Form 8-K
8-K — Aclaris Therapeutics, Inc.
Accession: 0001104659-26-119231
Filed: 2026-10-27
Period: 2026-10-27
CIK: 0001557746
SIC: 2834 (PHARMACEUTICAL PREPARATIONS)
Item: Entry into a Material Definitive Agreement
Item: Financial Statements and Exhibits
Documents
8-K — tm2628355d1_8k.htm (Primary)
EX-1.1 — EXHIBIT 1.1 (tm2628355d1_ex1-1.htm)
EX-4.1 — EXHIBIT 4.1 (tm2628355d1_ex4-1.htm)
EX-5.1 — EXHIBIT 5.1 (tm2628355d1_ex5-1.htm)
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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of
The Securities Exchange Act of 1934
Date of Report (Date of earliest event
reported): October 27, 2026
Aclaris Therapeutics, Inc.
(Exact name of registrant as specified in
its charter)
Delaware
001-37581
46-0571712
(State or other jurisdiction of
incorporation)
(Commission File Number)
(IRS Employer
Identification No.)
701 Lee Road, Suite 103
Wayne, PA 19087
(Address of principal executive offices,
including zip code)
(484) 324-7933
(Registrant’s telephone number, including
area code)
N/A
(Former name or former address, if changed
since last report)
Check the appropriate box below if the Form 8-K filing is intended
to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
¨ Written
communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
¨ Soliciting material pursuant to Rule
14a-12 under the Exchange Act (17 CFR 240.14a-12)
¨ Pre-commencement communications pursuant
to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
¨ Pre-commencement communications pursuant
to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Securities registered pursuant to Section 12(b) of the
Act:
Title of Each Class:
Trading
Symbol(s)
Name of Each Exchange on which
Registered
Common Stock, $0.00001 par value
ACRS
The Nasdaq Stock Market, LLC
Indicate by check mark whether the registrant is an emerging growth
company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange
Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company ¨
If an emerging growth company, indicate
by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial
accounting standards provided pursuant to Section 13(a) of the Exchange Act. ¨
Item 1.01
Entry into a Material Definitive Agreement.
On October 27, 2026, Aclaris
Therapeutics, Inc. (the “Company”) entered into an underwriting agreement (the “Underwriting Agreement”) with
Leerink Partners LLC, Piper Sandler & Co. and Cantor Fitzgerald & Co., as representatives of the underwriters (the “Underwriters”)
listed therein, to issue and sell 7,785,714 shares of common stock of the Company, par value $0.00001 per share (“Common Stock”)
and pre-funded warrants to purchase 6,500,000 shares of Common Stock (the “Pre-Funded Warrants”), in an underwritten offering
pursuant to an effective registration statement on Form S-3 (File No. 333-298084) and a related prospectus and prospectus supplement,
in each case filed with the Securities and Exchange Commission (the “Offering”). The offering price is $3.50 per share of
Common Stock and $3.49999 per Pre-Funded Warrant. The Company estimates that the net proceeds from the Offering will be approximately
$46.7 million, after deducting underwriting discounts and commissions and estimated offering expenses. The closing of the Offering is
expected to occur on October 28, 2026, subject to customary closing conditions.
The Pre-Funded Warrants have
a per share exercise price of $0.00001, subject to proportional adjustments in the event of stock splits or combinations or similar events.
The Pre-Funded Warrants are exercisable at any time after the date of issuance and will not expire until exercised in full.
A holder of Pre-Funded Warrants may not exercise the warrant if the holder, together with its affiliates, would beneficially
own more than 9.99% of the number of shares of Common Stock outstanding immediately after giving effect to such exercise. A holder of Pre-Funded Warrants
may increase or decrease this percentage to a percentage not in excess of 19.99% by providing notice to the Company, provided that any
increase will not be effective until the 61st day after such notice is delivered to the Company.
The Underwriting Agreement
contains customary representations, warranties, covenants and agreements by the Company, indemnification obligations of the Company and
the Underwriters, including for liabilities under the Securities Act of 1933, as amended (the “Securities Act”), other obligations
of the parties and termination provisions. The representations, warranties and covenants contained in the Underwriting Agreement were
made only for purposes of such agreement and as of specific dates, were solely for the benefit of the parties to such agreement, and may
be subject to limitations agreed upon by the contracting parties.
Copies of the Underwriting
Agreement and the form of Pre-Funded Warrant are filed as Exhibit 1.1 and 4.1, respectively, to this Current Report on Form 8-K and are
incorporated herein by reference. The foregoing description of the Underwriting Agreement and the Pre-Funded Warrants is qualified in
its entirety by reference to such exhibits. A copy of the opinion of Cooley LLP as to the legality of the shares of Common Stock, the
Pre-Funded Warrants and the shares of Common Stock underlying the Pre-Funded Warrants to be issued and sold in the Offering and related
consent is filed as Exhibit 5.1 to this Current Report on Form 8-K.
Cautionary Note Regarding Forward-Looking Statements
This Current Report on Form
8-K contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and
Section 21E of the Exchange Act, and such forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities
Litigation Reform Act of 1995. These statements may be identified by words such as “anticipate,” “believe,” “expect,”
“intend,” “may,” “plan,” “potential,” “will,” and similar expressions, and
are based on the Company’s current beliefs and expectations. These forward-looking statements include statements about the Company’s
offering, such as the expected net proceeds and anticipated closing date. These statements involve risks and uncertainties that could
cause actual results to differ materially from those reflected in such statements. Risks and uncertainties that may cause actual results
to differ materially include uncertainties related to market conditions and the completion of the offering on the anticipated terms or
at all, and other risks and uncertainties that are described in the Risk Factors section of the Company’s Annual Report on Form
10-K for the year ended December 31, 2025, and other filings the Company makes with the U.S. Securities and Exchange Commission from time
to time. These documents are available under the “SEC Filings” page of the “Investors” section of the Company’s
website at www.aclaristx.com. Any forward-looking statements speak only as of the date of this Current Report on Form 8-K and are based
on information available to the Company as of the date of this Current Report on Form 8-K, and the Company assumes no obligation to, and
does not intend to, update any forward-looking statements, whether as a result of new information, future events or otherwise.
Item 9.01
Financial Statements and Exhibits.
(d) Exhibits
Exhibit
Number
Exhibit
Description
1.1
Underwriting Agreement by and among Aclaris Therapeutics,
Inc., Leerink Partners LLC, Piper Sandler & Co. and Cantor Fitzgerald & Co., dated October 27, 2026.
4.1
Form of Pre-Funded Warrant
to Purchase Common Stock.
5.1
Opinion of Cooley LLP.
23.1
Consent of Cooley LLP (included
in Exhibit 5.1).
104
The cover page from Aclaris
Therapeutics, Inc.’s Form 8-K filed on October 27, 2026, formatted in Inline XBRL.
SIGNATURES
Pursuant to the requirements
of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto
duly authorized.
ACLARIS THERAPEUTICS, INC.
By:
/s/ Kevin Balthaser
Date: October 27, 2026
Kevin Balthaser
Chief Financial Officer
EX-1.1 — EXHIBIT 1.1
EX-1.1
Filename: tm2628355d1_ex1-1.htm · Sequence: 2
Exhibit 1.1
7,785,714 Shares
Pre-Funded Warrants to Purchase 6,500,000 Shares
of Common Stock
Aclaris Therapeutics, Inc.
UNDERWRITING AGREEMENT
October 27, 2026
LEERINK PARTNERS LLC
PIPER SANDLER & CO.
CANTOR FITZGERALD & CO.
As Representatives of the several Underwriters
c/o LEERINK PARTNERS LLC
1301 Avenue of the Americas, 5th Floor
New York, New York 10019
c/o PIPER SANDLER & CO.
350 North 5th Street, Suite 1000
Minneapolis, Minnesota 55401
c/o CANTOR FITZGERALD & CO.
110 East 59th Street
New York, New York 10022
Ladies and Gentlemen:
Introductory. Aclaris Therapeutics, Inc., a Delaware corporation
(the “Company”), proposes to issue and sell to the several underwriters named in Schedule A (the “Underwriters”)
(i) an aggregate of 7,785,714 shares of its common stock, par value $0.00001 per share (the “Shares”) and (ii) pre-funded
warrants of the Company to purchase an aggregate of 6,500,000 Shares (the “Pre-Funded Warrants”). The 7,785,714 Shares
to be sold by the Company are called the “Offered Shares.” The Offered Shares, together with the Pre-Funded Warrants,
are collectively called the “Offered Securities.” Shares issuable upon exercise of the Pre-Funded Warrants are called
the “Warrant Shares.”
Leerink Partners LLC (“Leerink Partners”),
Piper Sandler & Co. (“Piper Sandler”) and Cantor Fitzgerald & Co. (“Cantor”) have
agreed to act as representatives of the several Underwriters (in such capacity, the “Representatives”) in connection
with the offering and sale of the Offered Securities. To the extent there are no additional underwriters listed on Schedule A,
the term “Representatives” as used herein shall mean you, as Underwriters, and the term “Underwriters” shall mean
either the singular or the plural, as the context requires.
The Company has prepared and filed with the Securities
and Exchange Commission (the “Commission”) a shelf registration statement on Form S-3, File No. 333-298084,
including a base prospectus (the “Base Prospectus”) to be used in connection with the offering and sale of the Offered
Securities. Such registration statement, as amended, including the financial statements, exhibits and schedules thereto, in the form in
which it became effective under the Securities Act of 1933, as amended, and the rules and regulations promulgated thereunder (collectively,
the “Securities Act”), including all documents incorporated or deemed to be incorporated by reference therein and any
information deemed to be a part thereof at the time of effectiveness pursuant to Rule 430B under the Securities Act, is called the
“Registration Statement.” As used herein, the term “Prospectus” shall mean the prospectus supplement
to the Base Prospectus that describes the Offered Securities and the offering thereof, together with the Base Prospectus, in the form
first used by the Underwriters to confirm sales of the Offered Securities or in the form first made available to the Underwriters by the
Company to meet requests of purchasers pursuant to Rule 173 under the Securities Act. References herein to the Prospectus shall refer
to both the prospectus supplement and the Base Prospectus components of such prospectus. As used herein, “Applicable Time”
is 6:10 a.m. (New York City time) on October 27, 2026. As used herein, “free writing prospectus” has the
meaning set forth in Rule 405 under the Securities Act, and “Time of Sale Prospectus” means the Base Prospectus,
as amended or supplemented immediately prior to the Applicable Time, together with the free writing prospectuses, if any, identified in
Schedule B hereto, and the Pricing Information. As used herein, “Pricing Information” means (i) the number
of Offered Securities offered for sale and (ii) the offering price per Offered Security, in each case as set forth on the cover page of
the Prospectus. As used herein, “Road Show” means a “road show” (as defined in Rule 433 under the
Securities Act) relating to the offering of the Offered Securities contemplated hereby that is a “written communication” (as
defined in Rule 405 under the Securities Act). As used herein, “Written Testing-the-Waters Communication” means
each written communication (within the meaning of Rule 405 under the Securities Act) that is made in reliance on Rule 163B under
the Securities Act by the Company or any person authorized to act on behalf of the Company to one or more potential investors that are
qualified institutional buyers (“QIBs”) and/or institutions that are accredited investors (“IAIs”),
as such terms are respectively defined in Rule 144A and Rule 501(a) under the Securities Act, to determine whether such
investors might have an interest in the offering of the Offered Securities; “Oral Testing-the-Waters Communication”
means each oral communication, if any, made in reliance on Rule 163B under the Securities Act by the Company or any person authorized
to act on behalf of the Company made to one or more QIBs and/or one or more IAIs to determine whether such investors might have an interest
in the offering of the Offered Securities; “Marketing Materials” means any materials or information provided to investors
by, or with the approval of, the Company in connection with the marketing of the offering of the Offered Securities, including any roadshow
or investor presentations made to investors by the Company (whether in person or electronically); and “Permitted Testing-the-Waters
Communication” means the Written Testing-the-Waters Communication(s) and Marketing Materials listed on Schedule C
attached hereto.
All references in this Agreement to the Registration
Statement, the Base Prospectus and the Prospectus shall include the documents incorporated or deemed to be incorporated by reference therein.
All references in this Agreement to financial statements and schedules and other information which are “contained,” “included”
or “stated” in, or “part of” the Registration Statement, the Base Prospectus, the Time of Sale Prospectus or the
Prospectus, and all other references of like import, shall be deemed to mean and include all such financial statements and schedules and
other information which is or is deemed to be incorporated by reference in the Registration Statement, the Base Prospectus, the Time of
Sale Prospectus or the Prospectus, as the case may be. All references in this Agreement to amendments or supplements to the Registration
Statement, the Base Prospectus, the Time of Sale Prospectus or the Prospectus shall be deemed to mean and include the filing of any document
under the Securities Exchange Act of 1934, as amended, and the rules and regulations promulgated thereunder (collectively, the “Exchange
Act”) that is or is deemed to be incorporated by reference in the Registration Statement, the Base Prospectus, or the Prospectus,
as the case may be. All references in this Agreement to (i) the Registration Statement, the Base Prospectus or the Prospectus, any
amendments or supplements to any of the foregoing, or any free writing prospectus, shall include any copy thereof filed with the Commission
pursuant to its Electronic Data Gathering, Analysis and Retrieval System (“EDGAR”) and (ii) the Prospectus shall
be deemed to include any “electronic Prospectus” provided for use in connection with the offering of the Offered Securities
as contemplated by Section 3(n) of this Agreement.
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In the event that the Company has only one subsidiary,
then all references herein to “subsidiaries” of the Company shall be deemed to refer to such single subsidiary, mutatis
mutandis.
The Company hereby confirms its agreements with
the Underwriters as follows:
Section 1. Representations
and Warranties of the Company. The Company hereby represents, warrants and covenants to each Underwriter, as of the date of this Agreement
and as of the Closing Date (as hereinafter defined) as follows:
(a) Compliance
with Registration Requirements. The Registration Statement has become effective under the Securities Act. The Company has complied,
to the Commission’s satisfaction, with all requests of the Commission for additional or supplemental information, if any. No stop
order suspending the effectiveness of the Registration Statement is in effect and no proceedings for such purpose have been instituted
or are pending or, to the knowledge of the Company, are contemplated or threatened by the Commission. At the time the Registration Statement
was originally filed with the Commission, as well as at the time the Company or any person acting on its behalf (within the meaning,
for this clause only, of Rule 163(c) under the Securities Act) made any offer relating to the Offered Securities in reliance
on the exemption of Rule 163 under the Securities Act, the Company was a “well known seasoned issuer” as defined in
Rule 405 under the Securities Act. The Registration Statement is an “automatic shelf registration statement,” as defined
in Rule 405 under the Securities Act, and became effective on August 6, 2026. The Company has not received from the Commission
any notice pursuant to Rule 401(g)(2) under the Securities Act objecting to the Company’s use of the automatic shelf
registration form. The documents incorporated or deemed to be incorporated by reference in the Registration Statement, the Time of Sale
Prospectus and the Prospectus, at the time they were or hereafter are filed with the Commission, or became effective under the Exchange
Act, as the case may be, complied and will comply in all material respects with the requirements of the Exchange Act.
(b) Disclosure.
The Prospectus when first used or filed, as applicable, complied in all material respects with the Securities Act and, if filed by electronic
transmission pursuant to EDGAR, was identical (except as may be permitted by Regulation S-T under the Securities Act) to the copy
thereof delivered to the Underwriters for use in connection with the offer and sale of the Offered Securities. Each of the Registration
Statement and any post-effective amendment thereto, at the time it became or becomes effective, complied and will comply in all material
respects with the Securities Act and did not and will not contain any untrue statement of a material fact or omit to state a material
fact required to be stated therein or necessary to make the statements therein not misleading. As of the Applicable Time, the Time of
Sale Prospectus did not, and at the Closing Date will not, contain any untrue statement of a material fact or omit to state a material
fact necessary to make the statements therein, in the light of the circumstances under which they were made, not misleading. The Prospectus,
as of its date, did not, and at the Closing Date will not, contain any untrue statement of a material fact or omit to state a material
fact necessary in order to make the statements therein, in the light of the circumstances under which they were made, not misleading.
The representations and warranties set forth in the three immediately preceding sentences do not apply to statements in or omissions from
the Registration Statement or any post-effective amendment thereto, or the Prospectus or the Time of Sale Prospectus, or any amendments
or supplements thereto, made in reliance upon and in conformity with written information relating to any Underwriter furnished to the
Company in writing by the Representatives expressly for use therein, it being understood and agreed that the only such information consists
of the information described in Section 9(b) below. There are no contracts or other documents required to be described in the
Time of Sale Prospectus or the Prospectus or to be filed as an exhibit to the Registration Statement which have not been described or
filed as required.
-3-
(c) Free
Writing Prospectuses; Road Show. As of the determination date referenced in Rule 164(h) under the Securities Act, the
Company was not, is not or will not be (as applicable) an “ineligible issuer” in connection with the offering of the Offered
Securities pursuant to Rules 164, 405 and 433 under the Securities Act. Each free writing prospectus that the Company is required
to file pursuant to Rule 433(d) under the Securities Act has been, or will be, filed with the Commission in accordance with
the requirements of the Securities Act. Each free writing prospectus that the Company has filed, or is required to file, pursuant to Rule 433(d) under
the Securities Act or that was prepared by or on behalf of or used or referred to by the Company complies or will comply in all material
respects with the requirements of Rule 433 under the Securities Act, including timely filing with the Commission or retention where
required and legending, and each such free writing prospectus, as of its issue date and at all subsequent times through the completion
of the offer and sale of the Offered Securities did not, does not and will not include any information that conflicted, conflicts or will
conflict with the information contained in the Registration Statement or the Prospectus. Except for the free writing prospectuses, if
any, identified in Schedule B, and electronic road shows, if any, furnished to you before first use, the Company has not prepared,
used or referred to, and will not, without your prior written consent, prepare, use or refer to, any free writing prospectus. Each Road
Show, when considered together with the Time of Sale Prospectus, did not, as of the Applicable Time, contain any untrue statement of a
material fact or omit to state a material fact necessary to make the statements therein, in the light of the circumstances under which
they were made, not misleading.
(d) Distribution
of Offering Material By the Company. Prior to the completion of the Underwriters’ distribution of the Offered Securities,
the Company has not distributed and will not distribute any offering material in connection with the offering and sale of the Offered
Securities other than the Registration Statement, the Time of Sale Prospectus, the Prospectus or any free writing prospectus reviewed
and consented to by the Representatives and the free writing prospectuses, if any, identified on Schedule B hereto.
(e) Incorporated
Documents. The documents incorporated or deemed to be incorporated by reference in the Registration Statement, the Time of Sale
Prospectus and the Prospectus, when they were filed with the Commission, complied in all material respects with the requirements of the
Exchange Act, and none of such documents contain any untrue statement of a material fact or omit to state a material fact necessary to
make the statements therein, in the light of the circumstances under which they were made, not misleading; and any further documents so
filed and incorporated or deemed to be incorporated by reference in the Registration Statement, the Time of Sale Prospectus and the Prospectus,
when such documents are filed with the Commission, will comply in all material respects with the requirements of the Exchange Act and
will not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements therein, in
the light of the circumstances under which they were made, not misleading.
(f) Statistical
and Market-Related Data. The statistical, demographic and market-related data included or incorporated by reference in the Registration
Statement, the Time of Sale Prospectus and the Prospectus are based on or derived from sources that the Company believes to be reliable
and accurate or represent the Company’s good faith estimates that are made on the basis of data derived from such sources.
(g) Disclosure
Controls and Procedures; Deficiencies in or Changes to Internal Control Over Financial Reporting. The Company has established
and maintains disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)), which (i) are
designed to ensure that material information relating to the Company, including its consolidated subsidiaries, is made known to the Company’s
principal executive officer and its principal financial officer by others within those entities, particularly during the periods in which
the periodic reports required under the Exchange Act are being prepared; (ii) have been evaluated by management of the Company for
effectiveness as of the end of the Company’s most recent fiscal quarter; and (iii) are effective in all material respects to
perform the functions for which they were established. Based on the most recent evaluation of its disclosure controls and procedures,
the Company is not aware of (A) any significant deficiencies or material weaknesses in the design or operation of internal control
over financial reporting which are reasonably likely to adversely affect the Company’s ability to record, process, summarize and
report financial information; or (B) any fraud, whether or not material, that involves management or other employees who have a significant
role in the Company’s internal control over financial reporting. The Company is not aware of any change in its internal control
over financial reporting that has occurred during its most recent fiscal quarter that has materially affected, or is reasonably likely
to materially affect, the Company’s internal control over financial reporting.
-4-
(h) Authorization
of the Agreement. This Agreement has been duly authorized, executed and delivered by, and is a valid and binding agreement of,
the Company, enforceable in accordance with its terms, except as rights to indemnification hereunder may be limited by applicable law
and except as the enforcement hereof may be limited by bankruptcy, insolvency, reorganization, moratorium or other similar laws relating
to or affecting the rights and remedies of creditors or by general equitable principles.
(i) Authorization
of the Offered Securities. The Offered Shares have been duly authorized for issuance and sale pursuant to this Agreement and,
when issued and delivered by the Company against payment therefor pursuant to this Agreement, will be validly issued, fully paid and nonassessable;
and the issuance and sale of the Offered Shares is not subject to any preemptive rights, rights of first refusal or other similar rights
that have not been duly waived. The Pre-Funded Warrants have been duly authorized by the Company and, when executed and delivered by the
Company, will be valid and binding agreements of the Company, enforceable against the Company in accordance with their terms, except as
the enforcement thereof may be limited by bankruptcy, insolvency, reorganization, moratorium or other similar laws relating to or affecting
the rights and remedies of creditors or by general equitable principles. The Warrant Shares have been duly authorized and validly reserved
for issuance upon exercise of the Pre-Funded Warrants in a number sufficient to meet the current exercise requirements. The Warrant Shares,
when issued and delivered upon exercise of the Pre-Funded Warrants in accordance therewith, will be validly issued, fully paid and nonassessable,
and the issuance of the Warrant Shares is not subject to any preemptive rights, rights of first refusal or other similar rights to subscribe
for or purchase the Warrant Shares.
(j) XBRL.
The interactive data in eXtensible Business Reporting Language included or incorporated by reference in the Registration Statement, the
Time of Sale Prospectus and the Prospectus fairly presents the information called for in all material respects and has been prepared in
accordance with the Commission’s rules and guidelines applicable thereto.
(k) No
Applicable Registration or Other Similar Rights. There are no persons with registration or other similar rights to have any equity
or debt securities registered for sale under the Registration Statement or included in the offering contemplated by this Agreement, except
for such rights as have been duly waived.
(l) No
Material Adverse Change. Except as otherwise disclosed in the Registration Statement, the Time of Sale Prospectus and the Prospectus,
subsequent to the respective dates as of which information is given in the Registration Statement, the Time of Sale Prospectus and the
Prospectus: (i) there has been no material adverse change, or any development that could reasonably be expected to result in a material
adverse change, in (A) the condition, financial or otherwise, or in the earnings, business, operations or prospects, whether or not
arising from transactions in the ordinary course of business, of the Company and its subsidiaries, considered as one entity or (B) the
ability of the Company to consummate the transactions contemplated by this Agreement or perform its obligations hereunder (any such change
is called a “Material Adverse Change”); (ii) the Company and its subsidiaries, considered as one entity,
have not incurred any material liability or obligation, indirect, direct or contingent, not in the ordinary course of business nor entered
into any material transaction or agreement not in the ordinary course of business; and (iii) there has been no dividend or distribution
of any kind declared, paid or made by the Company or, except for dividends paid to the Company or other subsidiaries, by any of its subsidiaries
on any class of capital stock or repurchase or redemption by the Company or any of its subsidiaries of any class of capital stock.
-5-
(m) Independent
Accountants. PricewaterhouseCoopers LLP, which has expressed its opinion with respect to the financial statements (which term
as used in this Agreement includes the related notes thereto) filed with the Commission as a part of or incorporated by reference in the
Registration Statement, the Time of Sale Prospectus and the Prospectus is (i) an independent public or certified public accountant
as required by the Securities Act and the Exchange Act, (ii) in compliance with the applicable requirements relating to the qualification
of accountants under Rule 2-01 of Regulation S-X; and (iii) a registered public accounting firm as defined by the Public Company
Accounting Oversight Board (the “PCAOB”) whose registration has not been suspended or revoked and who has not requested
such registration to be withdrawn.
(n) Preparation
of the Financial Statements. The financial statements filed with the Commission as a part of or incorporated by reference in the
Registration Statement, the Time of Sale Prospectus, and the Prospectus present fairly, in all material respects, the consolidated financial
position of the Company and its subsidiaries as of and at the dates indicated and the results of their operations, changes in stockholders’
equity and cash flows for the periods specified. Such financial statements have been prepared in conformity with generally accepted accounting
principles as applied in the United States (“GAAP”) applied on a consistent basis throughout the periods involved,
except as may be expressly stated in the related notes thereto and except in the case of unaudited financial statements, which are subject
to normal and recurring year-end adjustments and do not contain certain footnotes as permitted by the applicable rules of the Commission.
No other financial statements or supporting schedules are required to be included in or incorporated in the Registration Statement, the
Time of Sale Prospectus or the Prospectus. The financial data set forth or incorporated in the Registration Statement, the Time of Sale
Prospectus and the Prospectus fairly present, in all material respects, the information set forth therein on a basis consistent with that
of the audited or unaudited financial statements contained, as applicable, incorporated or deemed to be incorporated in the Registration
Statement, the Time of Sale Prospectus and the Prospectus. To the Company’s knowledge, no person who has been suspended or barred
from being associated with a registered public accounting firm, or who has failed to comply with any sanction pursuant to Rule 5300
promulgated by the PCAOB, has participated in or otherwise aided the preparation of, or audited, the financial statements, supporting
schedules or other financial data filed with the Commission as a part of the Registration Statement, the Time of Sale Prospectus or the
Prospectus.
(o) Company’s
Accounting System. The Company and each of its subsidiaries make and keep accurate books and records and maintain a system of
internal accounting controls sufficient to provide reasonable assurance that (i) transactions are executed in accordance with management’s
general or specific authorization; (ii) transactions are recorded as necessary to permit preparation of financial statements in conformity
with GAAP and to maintain accountability for assets; (iii) access to assets is permitted only in accordance with management’s
general or specific authorization; (iv) the recorded accountability for assets is compared with existing assets at reasonable intervals
and appropriate action is taken with respect to any differences; and (v) the interactive data in eXtensible Business Reporting Language
included or incorporated by reference in the Registration Statement, the Time of Sale Prospectus and the Prospectus fairly presents the
information called for in all material respects and is prepared in accordance with the Commission’s rules and guidelines applicable
thereto.
-6-
(p) Incorporation
and Good Standing of the Company. The Company has been duly incorporated and is validly existing as a corporation in good standing
under the laws of the State of Delaware and has the power and authority (corporate or other) to own, lease and operate its properties
and to conduct its business as described in the Registration Statement, the Time of Sale Prospectus and the Prospectus and to enter into
and perform its obligations under this Agreement. The Company is duly qualified as a foreign corporation to transact business and is
in good standing in each jurisdiction (to the extent such concept applies) in which such qualification is required, whether by reason
of the ownership or leasing of property or the conduct of business, except where the failure to so qualify or to be in good standing,
individually or in the aggregate, would not reasonably be expected to result in a Material Adverse Change.
(q) Incorporation
and Good Standing of the Company’s Subsidiaries. Each subsidiary of the Company has been duly incorporated or organized,
as the case may be, and is validly existing as a corporation, partnership or limited liability company, as applicable, in good standing
under the laws of the jurisdiction of its incorporation or organization and has the power and authority (corporate or other) to own, lease
and operate its properties and to conduct its business as described in the Registration Statement, the Time of Sale Prospectus and the
Prospectus and is duly qualified as a foreign corporation, partnership or limited liability company, as applicable, to transact business
and is in good standing (to the extent such concept applies) in each jurisdiction in which such qualification is required, whether by
reason of the ownership or leasing of property or the conduct of business, except where the failure to so qualify or be in good standing
would not reasonably be expected, individually or in the aggregate, to result in a Material Adverse Change. All of the issued and outstanding
capital stock or other equity or ownership interests of each subsidiary have been duly authorized and validly issued, are fully paid and
nonassessable and are owned by the Company, directly or through subsidiaries, free and clear of any security interest, mortgage, pledge,
lien, encumbrance or adverse claim. The Company does not own or control, directly or indirectly, any corporation, association or other
entity other than (i) the subsidiaries listed on Exhibit 21.1 to the Company’s most recent annual report on Form 10-K
and (ii) such other entities omitted from Exhibit 21.1 which, when such omitted entities are considered in the aggregate as
a single subsidiary, would not constitute a “significant subsidiary” within the meaning of Rule 1-02(w) of Regulation
S-X.
(r) Capitalization
and Other Capital Stock Matters. The authorized, issued and outstanding capital stock of the Company is as set forth in the Registration
Statement, the Time of Sale Prospectus and the Prospectus under the caption “Description of Capital Stock” (other than for
subsequent issuances, if any, pursuant to employee benefit plans described in the Registration Statement, the Time of Sale Prospectus
and the Prospectus or upon the conversion or exercise of outstanding options, convertible securities or warrants or vesting of restricted
stock units, in each case as described in the Registration Statement, the Time of Sale Prospectus and the Prospectus). The Shares (including
the Offered Shares and the Warrant Shares) and the Pre-Funded Warrants conform in all material respects to the descriptions thereof contained
in the Registration Statement, the Time of Sale Prospectus and the Prospectus. All of the issued and outstanding Shares have been duly
authorized and validly issued, are fully paid and nonassessable and have been issued in compliance with applicable federal and state securities
laws. None of the outstanding Shares were issued in violation of any preemptive rights, rights of first refusal or other similar rights
to subscribe for or purchase securities of the Company that have not been duly waived or satisfied. There are no authorized or outstanding
options, warrants, preemptive rights, rights of first refusal or other rights to purchase, or equity or debt securities convertible into
or exchangeable or exercisable for, any capital stock of the Company or any of its subsidiaries other than those accurately described
in all material respects in the Registration Statement, the Time of Sale Prospectus and the Prospectus. The description of the Company’s
stock option, stock bonus and other stock plans or arrangements, and the options or other rights granted thereunder, set forth in the
Registration Statement, the Time of Sale Prospectus and the Prospectus, accurately and fairly presents in all material respects the information
required to be shown with respect to such plans, arrangements, options and rights.
-7-
(s) Stock
Exchange Listing. The Company is subject to and in compliance in all material respects with the reporting requirements of Section 13
or Section 15(d) of the Exchange Act. The Company’s common stock is registered pursuant to Section 12(b) of
the Exchange Act and is listed on The Nasdaq Global Select Market (the “Nasdaq”), and the Company has taken no action
designed to, or reasonably likely to have the effect of, terminating the registration of the Company’s common stock under the Exchange
Act or delisting the Company’s common stock from the Nasdaq, nor has the Company received any notification that the Commission
or the Nasdaq is contemplating terminating such registration or listing. To the Company’s knowledge, it is in compliance with all
applicable listing requirements of Nasdaq.
(t) Non-Contravention
of Existing Instruments; No Further Authorizations or Approvals Required. Neither the Company nor any of its subsidiaries is in
violation of its charter or by-laws, partnership agreement or operating agreement or similar organizational document, as applicable, or
is in default (or, with the giving of notice or lapse of time, would be in default) (“Default”) under any indenture,
mortgage, loan or credit agreement, note, contract, franchise, lease or other instrument to which the Company or any of its subsidiaries
is a party or by which it or any of them may be bound (including, without limitation, any credit agreement, indenture, pledge agreement,
security agreement or other instrument or agreement evidencing, guaranteeing, securing or relating to indebtedness of the Company or any
of its subsidiaries ), or to which any of the property or assets of the Company or any of its subsidiaries is subject (each, an “Existing
Instrument”), except for such Defaults as would not, individually or in the aggregate, result in a Material Adverse Change.
The Company’s execution, delivery and performance of this Agreement and the Pre-Funded Warrants, consummation of the transactions
contemplated hereby and thereby and by the Registration Statement, the Time of Sale Prospectus and the Prospectus and the issuance and
sale of the Offered Securities (including the use of proceeds from the sale of the Offered Securities as described in the Registration
Statement, the Time of Sale Prospectus and the Prospectus under the caption “Use of Proceeds”) (i) have been duly authorized
by all necessary corporate action and will not result in any violation of the provisions of the charter or by-laws, partnership agreement
or operating agreement or similar organizational document of the Company or any subsidiary, as applicable; (ii) will not conflict
with or constitute a breach of, or Default under, or result in the creation or imposition of any lien, charge or encumbrance upon any
property or assets of the Company or any of its subsidiaries pursuant to, or require the consent of any other party to, any Existing Instrument,
except for such conflicts, breaches, Defaults, liens, charges or encumbrances as would not, individually or in the aggregate, result in
a Material Adverse Change; and (iii) will not result in any violation of any law, administrative regulation or administrative or
court decree applicable to the Company or any subsidiary, except as would not reasonably be expected, individually or in the aggregate,
to result in a Material Adverse Change. No consent, approval, authorization or other order of, or registration or filing with, any court
or other governmental or regulatory authority or agency, is required for the Company’s execution, delivery and performance of this
Agreement and consummation of the transactions contemplated hereby and by the Registration Statement, the Time of Sale Prospectus and
the Prospectus, except such as have been obtained or made by the Company and are in full force and effect under the Securities Act, applicable
state securities or blue sky laws, and from the Financial Industry Regulatory Authority (“FINRA”).
(u) No
Material Actions or Proceedings. Except as otherwise disclosed in the Registration Statement, the Time of Sale Prospectus and
the Prospectus, there are no material legal or governmental actions, suits or proceedings pending or, to the Company’s knowledge,
threatened (i) against or affecting the Company or any of its subsidiaries; (ii) which have as the subject thereof any officer
or director of, or property owned or leased by, the Company or any of its subsidiaries; or (iii) relating to environmental or discrimination
matters; where in any such case (A) there is a reasonable possibility that such action, suit or proceeding might be determined adversely
to the Company, such subsidiary or such officer or director, (B) any such action, suit or proceeding, if so determined adversely,
would reasonably be expected to result in a Material Adverse Change or adversely affect the consummation of the transactions contemplated
by this Agreement, or (C) any such action, suit or proceeding is or would be material in the context of the sale of Offered Securities.
Except as otherwise disclosed in the Registration Statement, the Time of Sale Prospectus and the Prospectus, no material labor dispute
with the employees of the Company or any of its subsidiaries, or with the employees of any principal supplier, manufacturer, customer
or contractor of the Company, exists or, to the Company’s knowledge, is threatened or imminent.
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(v) Intellectual
Property Rights. The Company and its subsidiaries own or possess the valid right to use all (i) patents, patent applications,
trademarks, trademark registrations, service marks, service mark registrations, Internet domain name registrations, copyrights, copyright
registrations, licenses, trade secret rights (“Intellectual Property Rights”) and (ii) inventions, software, works
of authorships, trademarks, service marks, trade names, databases, formulae, know how, Internet domain names and other intellectual
property (including trade secrets and other unpatented and/or unpatentable proprietary confidential information, systems, or procedures)
(collectively, “Intellectual Property Assets”) necessary to conduct their respective businesses described in the Registration
Statement, the Time of Sale Prospectus and the Prospectus, except where the failure to own or possess the valid right to use the Intellectual
Property Assets would not, individually or in the aggregate, result in a Material Adverse Change. The Company and its subsidiaries have
not received any opinion from their legal counsel concluding that any activities of their respective businesses infringe, misappropriate,
or otherwise violate, valid and enforceable Intellectual Property Rights of any other person. The Company and its subsidiaries have not
received written notice of any challenge, which is to their knowledge still pending, by any other person to the rights of the Company
and its subsidiaries with respect to any Intellectual Property Rights or Intellectual Property Assets owned or used by the Company or
its subsidiaries that would reasonably be expected to result in a Material Adverse Change. To the knowledge of the Company, the Company
and its subsidiaries’ respective businesses as now conducted do not give rise to any infringement of, any misappropriation of, or
other violation of, any valid and enforceable Intellectual Property Rights of any other person. All licenses for the use of the Intellectual
Property Rights described in the Registration Statement, the Time of Sale Prospectus and the Prospectus are valid, binding upon, and enforceable
by or against the parties thereto in accordance to its terms. The Company has complied in all material respects with, and is not in breach
nor has received any asserted or threatened claim of breach of any Intellectual Property Rights license, and the Company has no knowledge
of any breach or anticipated breach by any other person to any Intellectual Property Rights license. Except as described in the Registration
Statement, the Time of Sale Prospectus or the Prospectus, no claim has been made against the Company alleging the infringement by the
Company of any patent, trademark, service mark, trade name, copyright, trade secret, license in or other intellectual property right or
franchise right of any person that would reasonably be expected to result in a Material Adverse Change. The Company has taken all reasonable
steps to protect, maintain and safeguard its Intellectual Property Rights, including the execution of appropriate nondisclosure and confidentiality
agreements. The consummation of the transactions contemplated by this Agreement will not result in the loss or impairment of or payment
of any additional amounts with respect to, nor require the consent of any other person in respect of, the Company’s right to own,
use, or hold for use any of the Intellectual Property Rights as owned, used or held for use in the conduct of the business as currently
conducted.
(w) All
Necessary Permits, etc. Except as otherwise disclosed in the Registration Statement, the Time of Sale Prospectus and the
Prospectus, the Company and each subsidiary possess such valid and current certificates, authorizations or permits issued by the appropriate
state, federal or foreign regulatory agencies or bodies necessary for the ownership or lease of its properties or the conduct of its business
(“Permits”) as described in the Registration Statement, the Time of Sale Prospectus and the Prospectus, or to permit
all clinical and nonclinical studies and trials conducted by or on behalf of the Company and its subsidiaries, except where failure to
so possess would not reasonably be expected to, individually or in the aggregate, result in a Material Adverse Change; and neither
the Company nor any subsidiary has received, or has any reason to believe that it will receive, any notice of proceedings relating to
the revocation or modification of, or non-compliance with, any such certificate, authorization or permit which, singly or in the aggregate,
if the subject of an unfavorable decision, ruling or finding, could result in a Material Adverse Change.
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(x) Title
to Properties. The Company and its subsidiaries have good and marketable title to all of the real and personal property and other
assets reflected as owned in the financial statements referred to in Section 1(n) above (or elsewhere in the Registration Statement,
the Time of Sale Prospectus or the Prospectus), in each case free and clear of any security interests, mortgages, liens, encumbrances,
equities, adverse claims and other defects, except such as would not reasonably be expected, individually or in the aggregate, to have
a Material Adverse Change. The real property, improvements, equipment and personal property held under lease by the Company or any of
its subsidiaries are held under valid and enforceable leases, with such exceptions as are not material and do not materially interfere
with the use made or proposed to be made of such real property, improvements, equipment or personal property by the Company or such subsidiary.
(y) Tax
Law Compliance. The Company and its consolidated subsidiaries have filed all necessary federal, state and foreign income, property
and franchise tax returns (or have properly requested extensions thereof) and have paid all taxes required to be paid by any of them and,
if due and payable, any related or similar assessment, fine or penalty levied against any of them except as may be being contested in
good faith and by appropriate proceedings. The Company has made adequate charges, accruals and reserves in the applicable financial statements
referred to in Section 1(n) above in respect of all federal, state and foreign income, property and franchise taxes for all
periods as to which the tax liability of the Company or any of its consolidated subsidiaries has not been finally determined.
(z) Company
Not an “Investment Company.” The Company is not, and after receipt of payment for the Offered Securities will not
be, an “investment company” within the meaning of the Investment Company Act of 1940, as amended (the “Investment
Company Act”).
(aa) Insurance.
Except as otherwise disclosed in the Registration Statement, the Time of Sale Prospectus and the Prospectus, each of the Company and its
subsidiaries are insured by recognized, financially sound and reputable institutions with policies in such amounts and with such deductibles
and covering such risks as are generally deemed adequate and customary for their businesses including, but not limited to, policies covering
real and personal property owned or leased by the Company and its subsidiaries against theft, damage, destruction, acts of vandalism and
earthquakes and policies covering the Company and its subsidiaries for product liability claims and clinical trial liability claims. The
Company has no reason to believe that it or any subsidiary will not be able (i) to renew its existing insurance coverage as and when
such policies expire; or (ii) to obtain comparable coverage from similar institutions as may be necessary or appropriate to
conduct its business as now conducted and at a cost that would not result in a Material Adverse Change. Neither of the Company nor any
subsidiary has been denied any insurance coverage which it has sought or for which it has applied.
(bb) No
Price Stabilization or Manipulation; Compliance with Regulation M. Neither the Company nor any of its subsidiaries has taken,
directly or indirectly, any action designed to or that would reasonably be expected to cause or result in stabilization or manipulation
of the price of the Shares or any other “reference security” (as defined in Rule 100 of Regulation M under the Exchange
Act (“Regulation M”)), whether to facilitate the sale or resale of the Offered Securities or otherwise, and has taken
no action which would directly or indirectly violate Regulation M. The Company acknowledges that the Underwriters may engage in passive
market making transactions in the Shares on the Nasdaq in accordance with Regulation M. The Shares are “actively traded securities”
(as defined in Regulation M).
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(cc) Related
Party Transactions. There are no business relationships or related-party transactions involving the Company or any of its subsidiaries
or any other person required to be described in Registration Statement, the Time of Sale Prospectus or the Prospectus which have not
been described as required.
(dd) FINRA
Matters. All of the information provided to the Underwriters or to counsel for the Underwriters by the Company, its officers and
directors and the holders of any securities (debt or equity) or options to acquire any securities of the Company in connection with letters,
filings or other supplemental information provided to FINRA pursuant to FINRA Rules 5110, 5190 and 5121 is true, complete and correct.
The Company meets the definition of an “experienced issuer” as specified in FINRA Rule 5110(j)(6). Neither the Company
nor any of its affiliates directly, or indirectly through one or more intermediaries, controls, or is controlled by, or is under common
control with, or is a person associated with any member firm of FINRA.
(ee) No
Unlawful Contributions or Other Payments. Except as otherwise disclosed in Registration Statement, the Time of Sale Prospectus
or the Prospectus, neither the Company nor any of its subsidiaries nor, to the Company’s knowledge, any employee or agent of the
Company or any subsidiary, has made any contribution or other payment to any official of, or candidate for, any federal, state or foreign
office in violation of any law or of the character required to be disclosed in the Registration Statement, the Time of Sale Prospectus
and the Prospectus.
(ff) Compliance
with Environmental Laws. Except as otherwise described in Registration Statement, the Time of Sale Prospectus or the Prospectus,
and except as would not, individually or in the aggregate, result in a Material Adverse Change (i) neither the Company nor any of
its subsidiaries is in violation of any federal, state, local or foreign law or regulation relating to pollution or protection of human
health or the environment (including, without limitation, ambient air, surface water, groundwater, land surface or subsurface strata)
or wildlife, including without limitation, laws and regulations relating to emissions, discharges, releases or threatened releases of
chemicals, pollutants, contaminants, wastes, toxic substances, hazardous substances, petroleum and petroleum products (collectively, “Materials
of Environmental Concern”), or otherwise relating to the manufacture, processing, distribution, use, treatment, storage, disposal,
transport or handling of Materials of Environmental Concern (collectively, “Environmental Laws”), which violation includes,
but is not limited to, noncompliance with any permits or other governmental authorizations required for the operation of the business
of the Company or its subsidiaries under applicable Environmental Laws, or noncompliance with the terms and conditions thereof, nor has
the Company or any of its subsidiaries received any written communication, whether from a governmental authority, citizens group, employee
or otherwise, that alleges that the Company or any of its subsidiaries is in violation of any Environmental Law; (ii) there is no
claim, action or cause of action filed with a court or governmental authority, no investigation with respect to which the Company has
received written notice, and no written notice by any person or entity alleging potential liability for investigatory costs, cleanup costs,
governmental responses costs, natural resources damages, property damages, personal injuries, attorneys’ fees or penalties arising
out of, based on or resulting from the presence, or release into the environment, of any Material of Environmental Concern at any location
owned, leased or operated by the Company or any of its subsidiaries, now or in the past (collectively, “Environmental Claims”),
pending or, to the Company’s knowledge, threatened against the Company or any of its subsidiaries or any person or entity whose
liability for any Environmental Claim the Company or any of its subsidiaries has retained or assumed either contractually or by operation
of law; and (iii) to the Company’s knowledge, there are no past or present actions, activities, circumstances, conditions,
events or incidents, including, without limitation, the release, emission, discharge, presence or disposal of any Material of Environmental
Concern, that reasonably could result in a violation of any Environmental Law or form the basis of a potential Environmental Claim against
the Company or any of its subsidiaries or against any person or entity whose liability for any Environmental Claim the Company or any
of its subsidiaries has retained or assumed either contractually or by operation of law.
-11-
(gg) ERISA
Compliance. The Company and its subsidiaries and any “employee benefit plan” (as defined under the Employee Retirement
Income Security Act of 1974, as amended, and the regulations and published interpretations thereunder (collectively, “ERISA”))
established or maintained by the Company, its subsidiaries or their “ERISA Affiliates” (as defined below), are in compliance
in all material respects with ERISA. “ERISA Affiliate” means, with respect to the Company or any of its subsidiaries,
any member of any group of organizations described in Sections 414(b), (c), (m) or (o) of the Internal Revenue Code of 1986,
as amended, and the regulations and published interpretations thereunder (the “Code”) of which the Company or such
subsidiary is a member. No “reportable event” (as defined under ERISA) has occurred or is reasonably expected to occur with
respect to any “employee benefit plan” established or maintained by the Company, its subsidiaries or any of their ERISA Affiliates.
Except as would not reasonably be expected, individually or in the aggregate, to result in a Material Adverse Change, no “employee
benefit plan” established or maintained by the Company, its subsidiaries or any of their ERISA Affiliates, if such “employee
benefit plan” were terminated, would have any “amount of unfunded benefit liabilities” (as defined under ERISA). Neither
the Company, its subsidiaries nor any of their ERISA Affiliates has incurred or reasonably expects to incur any liability under (i) Title
IV of ERISA with respect to termination of, or withdrawal from, any “employee benefit plan” or (ii) Sections 412, 4971,
4975 or 4980B of the Code. Each employee benefit plan established or maintained by the Company, its subsidiaries or any of their ERISA
Affiliates that is intended to be qualified under Section 401(a) of the Code is so qualified and nothing has occurred, whether
by action or failure to act, which would cause the loss of such qualification.
(hh) Brokers.
Except for the Underwriters, there is no broker, finder or other party that is entitled to receive from the Company any brokerage or finder’s
fee or other fee or commission as a result of any transactions contemplated by this Agreement.
(ii) No
Outstanding Loans or Other Extensions of Credit. Except as described in Registration Statement, the Time of Sale Prospectus or
the Prospectus, there are no outstanding loans, advances (except normal advances for business expenses in the ordinary course of business)
or guarantees or indebtedness by the Company to or for the benefit of any of the officers or directors of the Company or any of the immediate
family members of any of them.
(jj) Compliance
with Laws. The Company has not been advised, and has no reason to believe, that it and each of its subsidiaries are not conducting
business in compliance with all applicable laws, rules and regulations of the jurisdictions in which it is conducting business, except
where failure to be so in compliance would not be reasonably expected to result in a Material Adverse Change.
(kk) Dividend
Restrictions. Except as disclosed in the Registration Statement, the Time of Sale Prospectus and the Prospectus, no subsidiary
of the Company is prohibited or restricted, directly or indirectly, from paying dividends to the Company, or from making any other distribution
with respect to such subsidiary’s equity securities or from repaying to the Company or any other subsidiary of the Company any
amounts that may from time to time become due under any loans or advances to such subsidiary from the Company or from transferring any
property or assets to the Company or to any other subsidiary.
-12-
(ll) Anti-Corruption
and Anti-Bribery Laws. Neither the Company nor any of its subsidiaries nor, to the knowledge of the Company, any director, officer,
agent, employee, affiliate or other person acting on behalf of the Company or any of its subsidiaries has, in the course of its actions
for, or on behalf of, the Company or any of its subsidiaries (i) used any corporate funds for any unlawful contribution, gift, entertainment
or other unlawful expenses relating to political activity; (ii) made or taken any act in furtherance of an offer, promise, or authorization
of any direct or indirect unlawful payment or benefit to any foreign or domestic government official or employee, including of any government-owned
or controlled entity or public international organization, or any political party, party official, or candidate for political office;
(iii) violated or is in violation of any provision of the U.S. Foreign Corrupt Practices Act of 1977, as amended (the “FCPA”),
the UK Bribery Act 2010, or any other applicable anti-bribery or anti-corruption law; or (iv) made, offered, authorized, requested,
or taken an act in furtherance of any unlawful bribe, rebate, payoff, influence payment, kickback or other unlawful payment or benefit.
The Company and its subsidiaries and, to the knowledge of the Company, the Company’s affiliates have conducted their respective
businesses in compliance with the FCPA and have instituted and maintain policies and procedures designed to ensure, and which are reasonably
expected to continue to ensure, continued compliance therewith.
(mm) Money
Laundering Laws. The operations of the Company and its subsidiaries are, and have been conducted at all times, in compliance with
applicable financial recordkeeping and reporting requirements of the Currency and Foreign Transactions Reporting Act of 1970, as amended,
the money laundering statutes of all applicable jurisdictions, the rules and regulations thereunder and any related or similar applicable
rules, regulations or guidelines, issued, administered or enforced by any governmental agency (collectively, the “Money Laundering
Laws”) and no action, suit or proceeding by or before any court or governmental agency, authority or body or any arbitrator
involving the Company or any of its subsidiaries with respect to the Money Laundering Laws is pending or, to the knowledge of the Company,
threatened.
(nn) Clinical
Studies. The preclinical tests and clinical trials, and other studies (collectively, “studies”) conducted by
or on behalf of or sponsored by the Company or any of its subsidiaries or in which the Company or any of its subsidiaries or their products
or product candidates have participated were and, if still pending, are being conducted in all material respects in accordance with the
protocols, procedures and controls designed and approved for such studies and all applicable laws and regulations, including, without
limitation, 21 C.F.R. Parts 50, 54, 56, 58, 312 and 812; each description of the results of such studies is accurate and complete in all
material respects and fairly presents the data derived from such studies, and the Company and its subsidiaries have no knowledge of any
other studies the results of which are inconsistent with, or otherwise call into question, the results described or referred to in Registration
Statement, the Time of Sale Prospectus or the Prospectus; no investigational new drug application filed by or on behalf of the Company
or any of its subsidiaries with the U.S. Food and Drug Administration (“FDA”) has been terminated or suspended by the
FDA, and neither the FDA nor any applicable foreign regulatory agency has commenced, or, to the knowledge of the Company, threatened to
initiate, any action to place a clinical hold order on, or otherwise terminate, delay or suspend, any proposed or ongoing studies conducted
or proposed to be conducted by or on behalf of the Company or any of its subsidiaries; the Company and its subsidiaries have made all
such filings and hold all such Permits for the operation of its business required by the FDA or any committee thereof or from any other
U.S. or foreign government or drug or medical device regulatory agency, or health care facility Institutional Review Board (collectively,
the “Regulatory Agencies”); and the Company and its subsidiaries have fulfilled and performed all of their material
obligations with respect to such Permits, and no event has occurred which allows, or after notice or lapse of time would allow, revocation
or termination thereof or results in any other material impairment of the rights of the holder of any such Permit.
-13-
(oo) Compliance
with Health Care Laws. The Company and its subsidiaries are, and at all times have been, in compliance in all respects with all
applicable Health Care Laws (as defined below), and have not engaged in activities which are, as applicable, cause for false claims liability,
civil penalties, or mandatory or permissive exclusion from Medicare, Medicaid, or any other state health care program or federal health
care program, except as would not reasonably be expected, individually or in the aggregate, to have a Material Adverse Change. For purposes
of this Agreement, “Health Care Laws” means: (i) the Federal Food, Drug, and Cosmetic Act and the regulations
promulgated thereunder; (ii) all applicable federal, state, local and all applicable foreign health care related fraud and abuse
laws, including, without limitation, the U.S. Anti-Kickback Statute (42 U.S.C. Section 1320a-7b(b)), the U.S. Physician Payments
Sunshine Act (42 U.S.C. § 1320a-7h), the U.S. Civil False Claims Act (31 U.S.C. Section 3729 et seq.), the criminal False Claims
Law (42 U.S.C. § 1320a-7b(a)), all criminal laws relating to health care fraud and abuse, including but not limited to 18 U.S.C.
Sections 286 and 287, and the health care fraud criminal provisions under the U.S. Health Insurance Portability and Accountability Act
of 1996 (“HIPAA”) (42 U.S.C. Section 1320d et seq.), the exclusions law (42 U.S.C. § 1320a-7), the civil
monetary penalties law (42 U.S.C. § 1320a-7a), HIPAA, as amended by the Health Information Technology for Economic and Clinical Health
Act (42 U.S.C. Section 17921 et seq.) (“HITECH”), and the regulations promulgated pursuant to such statutes; (iii) Medicare
(Title XVIII of the Social Security Act); (iv) Medicaid (Title XIX of the Social Security Act); and (v) any and all other applicable
health care laws and regulations. Neither the Company nor any of its subsidiaries have received notice of any claim, action, suit, proceeding,
hearing, enforcement, audit, investigation, arbitration or other action from any court or arbitrator or governmental or regulatory authority
or third party alleging that any product operation or activity is in material violation of any Health Care Laws, and, to the Company’s
knowledge, no such claim, action, suit, proceeding, hearing, enforcement, audit, investigation, arbitration or other action is threatened.
Neither the Company nor any of its subsidiaries are a party to or have any ongoing reporting obligations pursuant to any corporate integrity
agreements, deferred prosecution agreements, monitoring agreements, consent decrees, settlement orders, plans of correction or similar
agreements with or imposed by any Regulatory Agency or other governmental or regulatory authority. Additionally, neither the Company nor
any of its subsidiaries, nor any of their respective employees, officers or directors has been excluded, suspended or debarred from participation
in any U.S. federal health care program or human clinical research or, to the knowledge of the Company, is subject to a governmental inquiry,
investigation, proceeding, or other similar action that could reasonably be expected to result in debarment, suspension, or exclusion.
(pp) Sanctions.
Neither the Company nor any of its subsidiaries, directors, officers, or employees, nor, to the knowledge of the Company, after due inquiry,
any agent, affiliate or other person acting on behalf of the Company or any of its subsidiaries is currently the subject or the target
of any U.S. sanctions administered by the Office of Foreign Assets Control of the U.S. Department of the Treasury or the U.S. Department
of State, the United Nations Security Council, the European Union, His Majesty’s Treasury of the United Kingdom, or other relevant
sanctions authority (collectively, “Sanctions”); nor is the Company or any of its subsidiaries located, organized or
resident in a country or territory that is the subject or the target of Sanctions, currently, the so-called Donetsk People’s Republic,
the so-called Luhansk People’s Republic, the non-government controlled areas of the Zaporizhzhia and Kherson Regions, Cuba, Iran,
North Korea and the Crimea Region (collectively, “Sanctioned Countries” and each, a “Sanctioned Country”);
and the Company will not directly or indirectly use the proceeds of this offering, or lend, contribute or otherwise make available such
proceeds to any subsidiary, or any joint venture partner or other person or entity, for the purpose of financing the activities of or
business with any person, or in any country or territory, that at the time of such financing, is the subject or the target of Sanctions
or in any other manner that will result in a violation by any person (including any person participating in the transaction whether as
underwriter, advisor, investor or otherwise) of applicable Sanctions. For the past five years, the Company and its subsidiaries have not
knowingly engaged in and are not now knowingly engaged in any dealings or transactions with any person that at the time of the dealing
or transaction is or was the subject or the target of Sanctions or with any Sanctioned Country.
(qq) Sarbanes-Oxley.
The Company is in compliance, in all material respects, with all applicable provisions of the Sarbanes-Oxley Act of 2002, as amended,
and the rules and regulations promulgated thereunder.
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(rr) Duties,
Transfer Taxes, Etc. No stamp or other issuance or transfer taxes or duties and no capital gains, income, withholding or other
taxes are payable by the Underwriters in the United States or any political subdivision or taxing authority thereof or therein in connection
with the execution, delivery or performance of this Agreement by the Company or the sale and delivery by the Company of the Offered Securities.
(ss) Cybersecurity.
To the Company’s knowledge, the Company and its subsidiaries’ information technology assets and equipment, computers, systems,
networks, hardware, software, websites, applications, and databases (collectively, “IT Systems”) are adequate for,
and operate and perform in all material respects as required in connection with the operation of the business of the Company and its subsidiaries
as currently conducted, free and clear of all material bugs, errors, defects, Trojan horses, time bombs, malware and other corruptants.
The Company and its subsidiaries have implemented and maintained commercially reasonable physical, technical and administrative controls,
policies, procedures, and safeguards to maintain and protect their material confidential information and the integrity, continuous operation,
redundancy and security of all IT Systems and data, including “Personal Data,” used in connection with their businesses. “Personal
Data” means (i) a natural person’s name, street address, telephone number, e-mail address, photograph, social security
number or tax identification number, driver’s license number, passport number, credit card number, bank information, or customer
or account number; (ii) any information which would qualify as “personally identifying information” under the Federal
Trade Commission Act, as amended; (iii) if applicable to the Company, “personal data” as defined by GDPR (as defined
below); (iv) if applicable to the Company, any information which would qualify as “protected health information” under
HIPAA, as amended by HITECH; and (v) any other piece of information that allows the identification of such natural person, or his
or her family, or permits the collection or analysis of any data related to an identified person’s health or sexual orientation.
To the Company’s knowledge, there have been no breaches, violations, outages or unauthorized uses of or accesses to the same, except
for those that have been remedied without material cost or liability or the duty to notify any other person, and there are no incidents
under internal review or investigations relating to the same. The Company and its subsidiaries are presently in material compliance with
all applicable laws or statutes and all judgments, orders, rules and regulations of any court or arbitrator or governmental or regulatory
authority, internal policies and contractual obligations relating to the privacy and security of IT Systems and Personal Data and to the
protection of such IT Systems and Personal Data from unauthorized use, access, misappropriation or modification.
(tt) Compliance
with Data Privacy Laws. The Company and its subsidiaries are, and at all prior times were, in material compliance with all applicable
state and federal data privacy and security laws and regulations, including without limitation HIPAA as amended by HITECH, and the Company
and its subsidiaries have taken commercially reasonable actions to prepare to comply with, and since May 25, 2018, have been and
currently are in compliance with, the European Union General Data Protection Regulation (“GDPR”) (EU 2016/679) (collectively,
the “Privacy Laws”) in all material respects. To ensure compliance with the Privacy Laws, the Company and its subsidiaries
have in place, comply with, and take appropriate steps reasonably designed to ensure compliance in all material respects with their policies
and procedures relating to data privacy and security and the collection, storage, use, disclosure, handling, and analysis of Personal
Data (the “Policies”). The Company and its subsidiaries have at all times made all disclosures to users or customers
required by applicable laws and regulatory rules or requirements, and none of such disclosures made or contained in any Policy have,
to the knowledge of the Company, been inaccurate or in violation of any applicable laws and regulatory rules or requirements in any
material respect. The Company further certifies that neither it nor any subsidiary: (i) has received written notice of any actual
or potential liability under or relating to, or actual or potential violation of, any of the Privacy Laws, and has no knowledge of any
event or condition that would reasonably be expected to result in any such notice; (ii) is currently conducting or paying for, in
whole or in part, any investigation, remediation, or other corrective action pursuant to any Privacy Law; or (iii) is a party to
any order, decree, or agreement that imposes any obligation or liability under any Privacy Law.
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(uu) No
Reliance. The Company has not relied upon the Underwriters or the Underwriters’ legal counsel for any legal, tax or accounting
advice in connection with the offering and sale of the Offered Securities.
(vv) Forward-Looking
Statements. No forward-looking statement (within the meaning of Section 27A of the Securities Act and Section 21E of
the Exchange Act) contained in the Registration Statement, the Time of Sale Prospectus or the Prospectus has been made or reaffirmed without
a reasonable basis or has been disclosed other than in good faith.
(ww) Outbound
Investment Rule. Neither the Company nor any of its subsidiaries is a “covered foreign person,” as that term is defined
in 31 C.F.R. Section 850.209. Neither the Company nor any of its subsidiaries currently engage, or have plans to engage, directly
or indirectly, in a “covered activity,” as that term is defined in 31 C.F.R. Section 850.208.
(xx) Parties
to Lock-Up Agreements. The Company has furnished to the Underwriters a letter agreement in the form attached hereto as Exhibit A
(the “Lock-up Agreement”) from each of the persons listed on Exhibit B. Such Exhibit B lists
under an appropriate caption the directors and executive officers of the Company. If any additional persons shall become directors or
executive officers of the Company prior to the end of the Lock-up Period (as defined below), the Company shall cause each such person,
prior to or contemporaneously with their appointment or election as a director or executive officer of the Company, to execute and deliver
to the Representatives a Lock-up Agreement.
(yy) Communications.
The Company (i) has not alone engaged in communications with potential investors in reliance on Rule 163B under the Securities
Act other than Permitted Testing-the-Waters Communications with the consent of the Representatives with entities that are QIBs or IAIs
and (ii) has not authorized anyone other than the Representatives to engage in such communications; the Company reconfirms that the
Representatives have been authorized to act on its behalf in providing Marketing Materials or in making Oral Testing-the-Waters Communications
and Written Testing-the-Waters Communications; as of the Applicable Time, each Permitted Testing-the-Waters Communication, when considered
together with the Time of Sale Prospectus, did not, as of the Applicable Time, include an untrue statement of a material fact or omit
to state a material fact necessary in order to make the statements therein, in the light of the circumstances under which they were made,
not misleading; and each Permitted Testing-the-Waters Communication, if any, does not, as of the date hereof, conflict with the information
contained in the Registration Statement and the Prospectus.
Section 2. Purchase,
Sale and Delivery of the Offered Securities.
(a) The
Offered Securities. Upon the terms herein set forth, the Company agrees to issue and sell to the several Underwriters an aggregate
of 7,785,714 Offered Shares and an aggregate of 6,500,000 Pre-Funded Warrants. On the basis of the representations, warranties and agreements
herein contained, and upon the terms but subject to the conditions herein set forth, the Underwriters agree, severally and not jointly,
to purchase from the Company the respective number of Offered Shares and Pre-Funded Warrants set forth opposite their names on Schedule
A. The purchase price per Offered Share to be paid by the several Underwriters to the Company shall be $3.29 per share and the purchase
price per Pre-Funded Warrant to be paid by the several Underwriters to the Company shall be $3.28999.
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(b) The
Closing Date. Delivery of the Offered Shares to be purchased by the Underwriters and payment therefor shall be made at the offices
of Covington & Burling LLP, 30 Hudson Yards, New York, NY 10001 (or such other place as may be agreed to by the Company and the
Representatives), and delivery of the Pre-Funded Warrants shall be made by the Company in accordance with instructions provided by the
Underwriters, in each case against payment therefor, at 9:00 a.m. New York City time, on October 28, 2026, or such other time
and date not later than 1:30 p.m. New York City time, on November 12, 2026 as the Representatives shall designate by notice
to the Company (the time and date of such closing are called the “Closing Date”). The Company hereby acknowledges that
circumstances under which the Representatives may provide notice to postpone the Closing Date as originally scheduled include, but are
not limited to, any determination by the Company or the Representatives to recirculate to the public copies of an amended or supplemented
Prospectus or a delay as contemplated by the provisions of Section 11.
(c) [Reserved].
(d) Offering
of the Offered Securities. The Representatives hereby advise the Company that the Underwriters intend to offer for sale, initially
on the terms set forth in the Registration Statement, the Time of Sale Prospectus and the Prospectus, their respective portions of the
Offered Securities as soon after this Agreement has been executed as the Representatives, in their sole judgment, have determined is advisable
and practicable.
(e) Payment
for the Offered Securities.
(i) Payment
for the Offered Securities shall be made at the Closing Date by wire transfer of immediately available funds to the order of the Company.
(ii) It
is understood that the Representatives have been authorized, for their own account and the accounts of the several Underwriters, to accept
delivery of and receipt for, and make payment of the purchase price for, the Offered Securities. Each of Leerink Partners, Piper Sandler
and Cantor, acting individually and not as a Representative of the Underwriters, may (but shall not be obligated to) make payment for
any Offered Securities to be purchased by any Underwriter whose funds shall not have been received by the Representatives by the Closing
Date, for the account of such Underwriter, but any such payment shall not relieve such Underwriter from any of its obligations under this
Agreement.
(f) Delivery
of the Offered Securities. Delivery of the Offered Shares at the Closing Date shall be made through the facilities of the Depository
Trust Company (“DTC”), unless the Representatives shall otherwise instruct, against release of a wire transfer of immediately
available funds for the amount of the purchase price therefor. The Offered Securities shall be registered in such names and denominations
as the Representatives shall have requested at least two full business days prior to the Closing Date and shall be made available for
inspection on the business day preceding the Closing Date at a location in New York City as the Representatives may designate. Notwithstanding
the foregoing, the Company and the Representatives shall instruct purchasers of the Pre-Funded Warrants to make payment
for the Pre-Funded Warrants on the Closing Date to the Company by wire transfer in immediately available funds to the account
specified by the Company at a purchase price of $3.49999 per Pre-Funded Warrant, in lieu of payment by the Underwriters for
such Pre-Funded Warrants, and the Company shall deliver such Pre-Funded Warrants to such purchasers on the Closing
Date against such payment, in lieu of the Company’s obligation to deliver such Pre-Funded Warrants to the Underwriters; provided
that, upon receipt by the Company of payment for the Pre-Funded Warrants, the Company shall promptly (but in no event later
than the Closing Date), pay $0.21 per such Pre-Funded Warrant to the Underwriters by wire transfer in immediately available
funds to the account specified by the Representatives. In the event that any purchaser of Pre-Funded Warrants fails to make
payment to the Company for all or part of such purchaser’s Pre-Funded Warrants on the Closing Date, the Representatives
may elect, by written notice to the Company, to receive Shares at the share purchase price specified in Section 2(a) in lieu
of all or a portion of such Pre-Funded Warrants to be delivered to the Underwriters under this Agreement.
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Section 3. Additional
Covenants.
The Company further covenants and agrees with each
Underwriter as follows:
(a) Delivery
of Registration Statement, Time of Sale Prospectus and Prospectus. The Company shall furnish to you in New York City, without
charge, prior to 10:00 a.m. New York City time on the business day next succeeding the date of this Agreement and during the period
when a prospectus relating to the Offered Securities is required by the Securities Act to be delivered (whether physically or through
compliance with Rule 172 under the Securities Act or any similar rule) in connection with sales of the Offered Securities, as many
copies of the Time of Sale Prospectus, the Prospectus and any supplements and amendments thereto or to the Registration Statement as you
may reasonably request.
(b) Representatives’
Review of Proposed Amendments and Supplements. During the period when a prospectus relating to the Offered Securities is required
by the Securities Act to be delivered (whether physically or through compliance with Rule 172 under the Securities Act or any similar
rule), the Company (i) will furnish to the Representatives for review, a reasonable period of time prior to the proposed time of
filing of any proposed amendment or supplement to the Registration Statement, a copy of each such amendment or supplement and (ii) will
not amend or supplement the Registration Statement (including any amendment or supplement through incorporation of any report filed under
the Exchange Act) without the Representatives’ prior written consent, which consent shall not be unreasonably withheld, conditioned
or delayed. Prior to amending or supplementing the Time of Sale Prospectus or the Prospectus (including any amendment or supplement through
incorporation of any report filed under the Exchange Act), the Company shall furnish to the Representatives for review, a reasonable amount
of time prior to the time of filing or use of the proposed amendment or supplement, a copy of each such proposed amendment or supplement.
The Company shall not file or use any such proposed amendment or supplement without the Representatives’ prior written consent,
which consent shall not be unreasonably withheld, conditioned or delayed. The Company shall file with the Commission within the applicable
period specified in Rule 424(b) under the Securities Act any prospectus required to be filed pursuant to such Rule.
(c) Free
Writing Prospectuses. The Company shall furnish to the Representatives for review, a reasonable amount of time prior to the proposed
time of filing or use thereof, a copy of each proposed free writing prospectus or any amendment or supplement thereto prepared by or on
behalf of, used by, or referred to by the Company, and the Company shall not file, use or refer to any proposed free writing prospectus
or any amendment or supplement thereto without the Representatives’ prior written consent, which consent shall not be unreasonably
withheld, conditioned or delayed. The Company shall furnish to each Underwriter, without charge, as many copies of any free writing prospectus
prepared by or on behalf of, used by or referred to by the Company as such Underwriter may reasonably request. If at any time when a prospectus
is required by the Securities Act to be delivered (whether physically or through compliance with Rule 172 under the Securities Act
or any similar rule) in connection with sales of the Offered Securities (but in any event if at any time through and including the Closing
Date) there occurred or occurs an event or development as a result of which any free writing prospectus prepared by or on behalf of, used
by, or referred to by the Company conflicted or would conflict with the information contained in the Registration Statement or included
or would include an untrue statement of a material fact or omitted or would omit to state a material fact necessary in order to make the
statements therein, in the light of the circumstances prevailing at such time, not misleading, the Company shall promptly amend or supplement
such free writing prospectus to eliminate or correct such conflict so that the statements in such free writing prospectus as so amended
or supplemented will not include an untrue statement of a material fact or omit to state a material fact necessary in order to make the
statements therein, in the light of the circumstances prevailing at such time, not misleading, as the case may be; provided, however,
that prior to amending or supplementing any such free writing prospectus, the Company shall furnish to the Representatives for review,
a reasonable amount of time prior to the proposed time of filing or use thereof, a copy of such proposed amended or supplemented free
writing prospectus, and the Company shall not file, use or refer to any such amended or supplemented free writing prospectus without the
Representatives’ prior written consent, which consent shall not be unreasonably delayed, withheld or conditioned.
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(d) Filing
of Underwriter Free Writing Prospectuses. The Company shall not take any action that would result in an Underwriter or the Company
being required to file with the Commission pursuant to Rule 433(d) under the Securities Act a free writing prospectus prepared
by or on behalf of such Underwriter that such Underwriter otherwise would not have been required to file thereunder.
(e) Amendments
and Supplements to Time of Sale Prospectus. If the Time of Sale Prospectus is being used to solicit offers to buy the Offered
Securities at a time when the Prospectus is not yet available to prospective purchasers, and any event shall occur or condition exist
as a result of which it is necessary to amend or supplement the Time of Sale Prospectus so that the Time of Sale Prospectus does not include
an untrue statement of a material fact or omit to state a material fact necessary in order to make the statements therein, in the light
of the circumstances when delivered to a prospective purchaser, not misleading, or if any event shall occur or condition exist as a result
of which the Time of Sale Prospectus conflicts with the information contained in the Registration Statement, or if, in the opinion of
counsel for the Company or counsel for the Underwriters, it is necessary to amend or supplement the Time of Sale Prospectus to comply
with applicable law, the Company shall (subject to Section 3(b) and Section 3(c) hereof) promptly prepare, file with
the Commission and furnish, at its own expense, to the Underwriters and to any dealer upon request, either amendments or supplements to
the Time of Sale Prospectus so that the statements in the Time of Sale Prospectus as so amended or supplemented will not include an untrue
statement of a material fact or omit to state a material fact necessary in order to make the statements therein, in the light of the circumstances
when delivered to a prospective purchaser, not misleading or so that the Time of Sale Prospectus, as amended or supplemented, will no
longer conflict with the information contained in the Registration Statement, or so that the Time of Sale Prospectus, as amended or supplemented,
will comply with applicable law.
(f) Certain
Notifications and Required Actions. After the date of this Agreement, the Company shall promptly advise the Representatives in
writing of: (i) the receipt of any comments of, or requests for additional or supplemental information from, the Commission; (ii) the
time and date of any filing of any post-effective amendment to the Registration Statement or any amendment or supplement to the Time of
Sale Prospectus, any free writing prospectus or the Prospectus; (iii) the time and date that any post-effective amendment to the
Registration Statement becomes effective; and (iv) the issuance by the Commission of any stop order suspending the effectiveness
of the Registration Statement or any post-effective amendment thereto or any amendment or supplement to the Time of Sale Prospectus or
the Prospectus or of any order preventing or suspending the use of the Time of Sale Prospectus, any free writing prospectus or the Prospectus,
or of any proceedings to remove, suspend or terminate from listing or quotation the Shares from any securities exchange upon which they
are listed for trading or included or designated for quotation, or of the threatening or initiation of any proceedings for any of such
purposes. If the Commission shall enter any such stop order at any time, the Company will use its reasonable best efforts to obtain the
lifting of such order as soon as possible. Additionally, the Company agrees that it shall comply with all applicable provisions of Rule 424(b),
Rule 433 and Rule 430B under the Securities Act and will use its reasonable efforts to confirm that any filings made by the
Company under Rule 424(b) or Rule 433 were received in a timely manner by the Commission. If, after the date of this Agreement
and during any time when a prospectus is required by the Securities Act to be delivered (whether physically or through compliance with
Rule 172 under the Securities Act or any similar rule), the Company receives notice pursuant to Rule 401(g)(2) under the
Securities Act from the Commission or otherwise ceases to be eligible to use the automatic shelf registration form, the Company shall
promptly advise the Representatives in writing (which may be by electronic mail) of such notice or ineligibility and will (i) promptly
file a new registration statement or post-effective amendment on the proper form relating to the Offered Securities, (ii) use its
best efforts to cause such registration statement or post-effective amendment to be declared effective by the Commission as soon as reasonably
practicable and (iii) promptly notify the Representatives in writing (which may be by electronic mail) of such effectiveness.
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(g) Amendments
and Supplements to the Prospectus and Other Securities Act Matters. If any event shall occur or condition exist as a result of
which it is necessary to amend or supplement the Prospectus so that the Prospectus does not include an untrue statement of a material
fact or omit to state a material fact necessary in order to make the statements therein, in the light of the circumstances when the Prospectus
is delivered (whether physically or through compliance with Rule 172 under the Securities Act or any similar rule) to a purchaser,
not misleading, or if in the opinion of the Representatives or counsel for the Underwriters it is otherwise necessary to amend or supplement
the Prospectus to comply with applicable law, the Company agrees (subject to Section 3(b) and Section 3(c)) hereof to promptly
prepare, file with the Commission and furnish, at its own expense, to the Underwriters and to any dealer upon request, amendments or supplements
to the Prospectus so that the statements in the Prospectus as so amended or supplemented will not include an untrue statement of a material
fact or omit to state a material fact necessary in order to make the statements therein, in the light of the circumstances when the Prospectus
is delivered (whether physically or through compliance with Rule 172 under the Securities Act or any similar rule) to a purchaser,
not misleading or so that the Prospectus, as amended or supplemented, will comply with applicable law. Neither the Representatives’
consent to, nor delivery of, any such amendment or supplement shall constitute a waiver of any of the Company’s obligations under
Section 3(b) or Section 3(c).
(h) Blue
Sky Compliance. The Company shall cooperate with the Representatives and counsel for the Underwriters to qualify or register the
Offered Securities for sale under (or obtain exemptions from the application of) the state securities or blue sky laws or Canadian provincial
securities laws (or other foreign laws) of those jurisdictions designated by the Representatives, shall comply with such laws and shall
continue such qualifications, registrations and exemptions in effect so long as required for the distribution of the Offered Securities.
The Company shall not be required to qualify as a foreign corporation or to take any action that would subject it to general service of
process in any such jurisdiction where it is not presently qualified or where it would be subject to taxation as a foreign corporation.
The Company will advise the Representatives promptly of the suspension of the qualification or registration of (or any such exemption
relating to) the Offered Securities for offering, sale or trading in any jurisdiction or any initiation or threat of any proceeding for
any such purpose, and in the event of the issuance of any order suspending such qualification, registration or exemption, the Company
shall use its reasonable best efforts to obtain the withdrawal thereof as soon as possible.
(i) Use
of Proceeds. The Company shall apply the net proceeds from the sale of the Offered Securities sold by it in all material respects
in the manner described under the caption “Use of Proceeds” in the Registration Statement, the Time of Sale Prospectus and
the Prospectus.
(j) Transfer
Agent. The Company shall engage and maintain, at its expense, a registrar and transfer agent for the Shares.
(k) Earnings
Statement. The Company will make generally available to its security holders and to the Representatives as soon as practicable
an earnings statement (which need not be audited) covering a period of at least twelve months beginning with the first fiscal quarter
of the Company commencing after the date of this Agreement that will satisfy the provisions of Section 11(a) of the Securities
Act and the rules and regulations of the Commission thereunder; provided, however, that the requirements of this Section 3(k) shall
be satisfied to the extent that such financial statements are available on EDGAR.
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(l) Continued
Compliance with Securities Laws. The Company will comply with the Securities Act and the Exchange Act so as to permit the completion
of the distribution of the Offered Securities as contemplated by this Agreement, the Registration Statement, the Time of Sale Prospectus
and the Prospectus. Without limiting the generality of the foregoing, the Company will, during the period when a prospectus relating to
the Offered Securities is required by the Securities Act to be delivered (whether physically or through compliance with Rule 172
under the Securities Act or any similar rule), file on a timely basis with the Commission and the Nasdaq all reports and documents required
to be filed under the Exchange Act.
(m) Listing.
The Company will use its best efforts to maintain the listing and trading, subject to notice of issuance, of the Offered Shares and the
Warrant Shares on the Nasdaq.
(n) Company
to Provide Copy of the Prospectus in Form That May be Downloaded from the Internet. If requested by the Representatives,
the Company shall cause to be prepared and delivered, at its expense, within one business day from the effective date of this Agreement,
to the Representatives an “electronic Prospectus” to be used by the Underwriters in connection with the offering and
sale of the Offered Securities. As used herein, the term “electronic Prospectus” means a form of Prospectus, and any
amendment or supplement thereto, that meets each of the following conditions: (i) it shall be encoded in an electronic format, satisfactory
to the Representatives, that may be transmitted electronically by the Representatives and the other Underwriters to offerees and purchasers
of the Offered Securities; (ii) it shall disclose the same information as the paper Prospectus, except to the extent that graphic
and image material cannot be disseminated electronically, in which case such graphic and image material shall be replaced in the electronic
Prospectus with a fair and accurate narrative description or tabular representation of such material, as appropriate; and (iii) it
shall be in or convertible into a paper format or an electronic format, satisfactory to the Representatives, that will allow investors
to store and have continuously ready access to the Prospectus at any future time, without charge to investors (other than any fee charged
for subscription to the Internet as a whole and for on-line time). The Company hereby confirms that it has included or will include in
the Prospectus filed pursuant to EDGAR or otherwise with the Commission and in the Registration Statement at the time it became effective
an undertaking that, upon receipt of a request by an investor or his or her representative, the Company shall transmit or cause to be
transmitted promptly, without charge, a paper copy of the Prospectus.
(o) Agreement
Not to Offer or Sell Additional Shares. During the period commencing on and including the date hereof and continuing through and
including the 60th day following the date of the Prospectus (such period being referred to herein as the “Lock-up Period”),
the Company will not, without the prior written consent of the Representatives (which consent may be withheld in their sole discretion),
directly or indirectly: (i) sell, offer to sell, contract to sell or lend any Shares or Related Securities (as defined below); (ii) effect
any short sale, or establish or increase any “put equivalent position” (as defined in Rule 16a-1(h) under the Exchange
Act) or liquidate or decrease any “call equivalent position” (as defined in Rule 16a-1(b) under the Exchange Act)
of any Shares or Related Securities; (iii) pledge, hypothecate or grant any security interest in any Shares or Related Securities;
(iv) in any other way transfer or dispose of any Shares or Related Securities; (v) enter into any swap, hedge or similar arrangement
or agreement that transfers, in whole or in part, the economic risk of ownership of any Shares or Related Securities, regardless of whether
any such transaction is to be settled in securities, in cash or otherwise; (vi) announce the offering of any Shares or Related Securities;
(vii) submit or file any registration statement under the Securities Act in respect of any Shares or Related Securities (other than
as contemplated by this Agreement with respect to the Offered Securities and other than filings of Form S-8 registration statements
relating to any stock-based compensation plans of the Company and its subsidiaries that are in existence at the Applicable Time and disclosed
in the Registration Statement, the Time of Sale Prospectus and the Prospectus (“Company Stock Plans”)); (viii) effect
a reverse stock split, recapitalization, share consolidation, reclassification or similar transaction affecting the outstanding Shares;
or (ix) publicly announce the intention to do any of the foregoing; provided, however, that the Company may (A) effect
the transactions contemplated hereby, (B) issue Shares or options to purchase Shares or restricted stock units, or issue Shares upon
exercise of options or vesting of restricted stock units pursuant to any Company Stock Plan described in the Registration Statement, the
Time of Sale Prospectus and the Prospectus, (C) issue and sell, from time to time, Shares pursuant to the conversion or exchange
of convertible or exchangeable securities or the exercise of options or warrants, in each case outstanding on the date hereof, (D) issue
Shares in connection with any joint venture, commercial or collaborative relationship or the acquisition or license by the Company of
the securities, businesses, property or other assets of another person or entity or pursuant to any employee benefit plan as assumed by
the Company in connection with any such acquisition; provided, however, that in the case of clause (D), (x) such Shares shall not
in the aggregate exceed five percent (5%) of the Company’s outstanding shares of common stock immediately following the consummation
of the offering of the Offered Securities contemplated by this Agreement and (y) the recipients thereof provide to the Representatives
a signed Lock-up Agreement in the form of Exhibit A hereto, or (E) issue and sell, from time to time, Shares pursuant
to the Second Amended and Restated Sales Agreement, dated August 6, 2026 (the “Sales Agreement”), by and among
the Company, Leerink Partners and Cantor, provided that no sales shall be made under the Sales Agreement until the 30th day following
the date of this Agreement. For purposes of the foregoing, “Related Securities” shall mean any options or warrants
or other rights to acquire Shares or any securities exchangeable or exercisable for or convertible into Shares, or to acquire other securities
or rights ultimately exchangeable or exercisable for, or convertible into, Shares.
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(p) Future
Reports to the Representatives. During the period of five years hereafter for so long as the Company is subject to the reporting
requirements of the Exchange Act, the Company will furnish to the Representatives, c/o Leerink Partners LLC, at 1301 Avenue of the Americas,
5th Floor, New York, New York 10019, Attention: Stuart R. Nayman; c/o Piper Sandler & Co., at 350 North 5th Street, Suite 1000,
Minneapolis, Minnesota 55401, Attention: Equity Capital Markets; and c/o Cantor Fitzgerald & Co., at 110 East 59th Street, New
York, New York 10022, Attention: Equity Capital Markets, with copies to Cantor Fitzgerald & Co., 110 East 59th Street, New York,
New York 10022, Attention: General Counsel: (i) as soon as practicable after the end of each fiscal year, copies of the Company’s
Annual Report on Form 10-K containing the balance sheet of the Company as of the close of such fiscal year and statements of income,
stockholders’ equity and cash flows for the year then ended and the opinion thereon of the Company’s independent public or
certified public accountants; (ii) as soon as practicable after the filing thereof, copies of each proxy statement, Annual Report
on Form 10-K, Quarterly Report on Form 10-Q, Current Report on Form 8-K or other report filed by the Company with the Commission;
and (iii) as soon as available, copies of any report or communication of the Company furnished or made available generally to holders
of its capital stock; provided, however, that the requirements of this Section 3(p) shall be satisfied to the extent
that such reports, statement, communications, financial statements or other documents are available on EDGAR.
(q) Investment
Limitation. The Company shall not invest or otherwise use the proceeds received by the Company from its sale of the Offered Securities
in such a manner as would require the Company or any of its subsidiaries to register as an investment company under the Investment Company
Act.
(r) No
Stabilization or Manipulation; Compliance with Regulation M. The Company will not take, and will ensure that no affiliate of the
Company will take, directly or indirectly, any action designed to or that would reasonably be expected to cause or result in stabilization
or manipulation of the price of the Shares or any reference security with respect to the Shares, whether to facilitate the sale or resale
of the Offered Securities or otherwise, and the Company will, and shall cause each of its affiliates to, comply with all applicable provisions
of Regulation M.
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(s) Enforce
Lock-Up Agreements. During the Lock-up Period, the Company will enforce all agreements between the Company and any of its securityholders
that restrict or prohibit, expressly or in operation, the offer, sale or transfer of Shares or Related Securities or any of the other
actions restricted or prohibited under the terms of the form of Lock-up Agreement. In addition, the Company will direct the transfer agent
to place stop transfer restrictions upon any such securities of the Company that are bound by such “lock-up” agreements for
the duration of the periods contemplated in such agreements, including, without limitation, “lock-up” agreements entered into
by the Company’s officers and directors pursuant to Section 6(i) hereof.
(t) Company
to Provide Interim Financial Statements. Prior to the Closing Date, the Company will furnish the Underwriters, as soon as they
have been prepared by or are available to the Company, a copy of any unaudited interim financial statements of the Company for any period
subsequent to the period covered by the most recent financial statements appearing in the Registration Statement and the Prospectus; provided,
however, that the requirements of this Section 3(t) shall be satisfied to the extent that such financial statements are
available on EDGAR.
(u) Amendments
and Supplements to Permitted Testing-the-Waters Communications. If at any time following the distribution of any Permitted Testing-the-Waters
Communication, there occurred or occurs an event or development as a result of which such Permitted Testing-the-Waters Communication included
or would include an untrue statement of a material fact or omitted or would omit to state a material fact necessary in order to make the
statements therein, in the light of the circumstances existing at that subsequent time, not misleading, the Company will promptly notify
the Representatives and will promptly amend or supplement, at its own expense, such Permitted Testing-the-Waters Communication to eliminate
or correct such untrue statement or omission.
(v) Warrant
Shares Reserved. The Company shall, at all times while any Pre-Funded Warrants are outstanding, reserve and keep
available out of the aggregate of its authorized but unissued and otherwise unreserved Shares, solely for the purpose of enabling it to
issue Warrant Shares upon exercise of such Pre-Funded Warrants, the number of Warrant Shares that are initially issuable and
deliverable upon the exercise of the then-outstanding Pre-Funded Warrants.
(w) Commission
Filing Fees. The Company agrees to pay the required Commission filing fees relating to the Offered Securities within the time
required by Rule 456(b)(1) under the Securities Act without regard to the proviso therein and otherwise in accordance with the
Rules 456(b) and 457(r) under the Securities Act.
The Representatives, on behalf
of the several Underwriters, may, in their sole discretion, waive in writing the performance by the Company of any one or more of the
foregoing covenants or extend the time for their performance.
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Section 4. Payment
of Expenses. The Company agrees to pay all costs, fees and expenses incurred in connection with the performance of its obligations
hereunder and in connection with the transactions contemplated hereby, including without limitation (i) all expenses incident to
the issuance and delivery of the Offered Securities (including all printing and engraving costs), (ii) all fees and expenses of
the registrar and transfer agent of the Shares, (iii) all necessary issue, transfer and other stamp taxes in connection with the
issuance and sale of the Offered Securities to the Underwriters, (iv) all fees and expenses of the Company’s counsel, independent
public or certified public accountants and other advisors, (v) all costs and expenses incurred in connection with the preparation,
printing, filing, shipping and distribution of the Registration Statement (including financial statements, exhibits, schedules, consents
and certificates of experts), the Time of Sale Prospectus, the Prospectus, any free writing prospectus prepared by or on behalf of, used
by, or referred to by the Company, each Permitted Testing-the-Waters Communication and all amendments and supplements thereto, and this
Agreement, (vi) all filing fees, attorneys’ fees and expenses incurred by the Company or the Underwriters in connection with
qualifying or registering (or obtaining exemptions from the qualification or registration of) all or any part of the Offered Securities
for offer and sale under the state securities or blue sky laws or the provincial securities laws of Canada, and, if requested by the
Representatives, preparing and printing a “Blue Sky Survey” or memorandum (such “Blue Sky Survey” or memorandum,
fees and expenses of counsel not to exceed $5,000) and a “Canadian wrapper,” and any supplements thereto, advising the Underwriters
of such qualifications, registrations and exemptions, (vii) the costs, fees and expenses incurred by the Underwriters in connection
with determining their compliance with the rules and regulations of FINRA related to the Underwriters’ participation in the
offering and distribution of the Offered Securities, including any related filing fees and the legal fees of, and disbursements by, counsel
to the Underwriters not to exceed $20,000 (exclusive of any filing fees) without the prior written consent of the Company, (viii) the
costs and expenses of the Company relating to investor presentations on any “road show”, any Permitted Testing-the-Waters
Communication or any Oral Testing-the-Waters Communication undertaken in connection with the offering of the Offered Securities, including,
without limitation, expenses associated with the preparation or dissemination of any electronic road show, expenses associated with the
production of road show slides and graphics, fees and expenses of any consultants engaged in connection with the road show presentations
with the prior approval of the Company, travel and lodging expenses of the representatives, employees and officers of the Company and
any such consultants, and 50% of the cost of any aircraft chartered in connection with the road show (the remaining 50% of the cost of
such aircraft to be paid by the Underwriters), (ix) the fees and expenses associated with listing the Offered Securities on the
Nasdaq, and (x) all other fees, costs and expenses of the nature referred to in Item 14 of Part II of the Registration Statement.
Except as provided in this Section 4 or in Section 7,
Section 9 or Section 10 hereof,
the Underwriters shall pay their own expenses, including the fees and disbursements of their counsel and their own travel and lodging
expenses.
Section 5. Covenant
of the Underwriters. Each Underwriter severally and not jointly covenants with the Company not to take any action that would result
in the Company being required to file with the Commission pursuant to Rule 433(d) under the Securities Act a free writing prospectus
prepared by or on behalf of such Underwriter that otherwise would not, but for such actions, be required to be filed by the Company under
Rule 433(d).
Section 6. Conditions
of the Obligations of the Underwriters. The respective obligations of the several Underwriters hereunder to purchase and pay for the
Offered Securities as provided herein on the Closing Date shall be subject to the accuracy of the representations and warranties on the
part of the Company set forth in Section 1 hereof as of the date hereof and as of
the Closing Date as though then made, to the timely performance by the Company of its covenants and other obligations hereunder, and to
each of the following additional conditions:
(a) Comfort
Letter. On the date hereof, the Representatives shall have received from PricewaterhouseCoopers LLP, independent registered public
accountants for the Company, a letter dated the date hereof addressed to the Underwriters, in form and substance satisfactory to the Representatives,
containing statements and information of the type ordinarily included in accountant’s “comfort letters” to underwriters,
delivered according to Statement of Auditing Standards No. 72 (or any successor bulletin), with respect to the audited and unaudited
financial statements and certain financial information contained in the Registration Statement, the Time of Sale Prospectus, and each
free writing prospectus, if any.
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(b) Compliance
with Registration Requirements; No Stop Order; No Objection from FINRA. For the period from and after the date of this Agreement
and through and including the Closing Date:
(i) The
Company shall have filed the Prospectus with the Commission (including the information previously omitted from the Registration Statement
pursuant to Rule 430B under the Securities Act) in the manner and within the time period required by Rule 424(b) under
the Securities Act; or the Company shall have filed a post-effective amendment to the Registration Statement containing the information
previously omitted from the Registration Statement pursuant to such Rule 430B, and such post-effective amendment shall have become
effective.
(ii) No
stop order suspending the effectiveness of the Registration Statement or any post-effective amendment to the Registration Statement shall
be in effect, and no proceedings for such purpose shall have been instituted or threatened by the Commission.
(iii) If
a filing has been made with FINRA, FINRA shall have raised no objection to the fairness and reasonableness of the underwriting terms and
arrangements.
(c) No
Material Adverse Change or Ratings Agency Change. For the period from and after the date of this Agreement and through and including
the Closing Date:
(i) in
the judgment of the Representatives there shall not have occurred any Material Adverse Change; and
(ii) there
shall not have occurred any downgrading, nor shall any notice have been given of any intended or potential downgrading or of any review
for a possible change that does not indicate the direction of the possible change, in the rating accorded any securities of the Company
or any of its subsidiaries by any “nationally recognized statistical rating organization” as that term is used in Rule 15c3-1(c)(2)(vi)(F) under
the Exchange Act.
(d) Opinion
of Counsel for the Company. On the Closing Date, the Representatives shall have received the opinion and negative assurance letter
of Cooley LLP, counsel for the Company, dated as of such date, in form and substance reasonably satisfactory to the Representatives.
(e) Opinion
of Intellectual Property Counsel. On the Closing Date, the Representatives shall have received the opinion of DLA Piper LLP, counsel
for the Company with respect to intellectual property matters, dated as of such date, in form and substance reasonably satisfactory to
the Representatives.
(f) Opinion
of Counsel for the Underwriters. On the Closing Date, the Representatives shall have received the opinion and negative assurance
letter of Covington & Burling LLP, counsel for the Underwriters in connection with the offer and sale of the Offered Securities,
in form and substance reasonably satisfactory to the Representatives, dated as of such date.
(g) Officers’
Certificate. On the Closing Date, the Representatives shall have received a certificate executed by the Chief Executive Officer
or President of the Company and the Chief Financial Officer of the Company, dated as of such date, to the effect set forth in Section 6(b)(ii) and
further to the effect that:
(i) for
the period from and including the date of this Agreement through and including such date, there has not occurred any Material Adverse
Change;
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(ii) the
representations, warranties and covenants of the Company set forth in Section 1 of this Agreement are true and correct with the same
force and effect as though expressly made on and as of such date; and
(iii) the
Company has complied with all the agreements hereunder and satisfied all the conditions on its part to be performed or satisfied hereunder
at or prior to such date.
(h) Bring-down
Comfort Letter. On the Closing Date the Representatives shall have received from PricewaterhouseCoopers LLP, independent registered
public accountants for the Company, a letter dated such date, in form and substance satisfactory to the Representatives, which letter
shall: (i) reaffirm the statements made in the letter furnished by them pursuant to Section 6(a),
except that the specified date referred to therein for the carrying out of procedures shall be no more than three business days prior
to the Closing Date; and (ii) cover certain financial information contained in the Prospectus.
(i) Lock-Up
Agreements. On or prior to the date hereof, the Company shall have furnished to the Representatives an agreement in the form of
Exhibit A hereto from each of the persons listed on Exhibit B hereto, and each such agreement shall be in full
force and effect on the Closing Date.
(j) [Reserved].
(k) CFO
Certificate. On the date of this Agreement and on the Closing Date, the Company shall have furnished to the Representatives a
certificate, dated the respective dates of delivery thereof and addressed to the Underwriters, of its chief financial officer with respect
to certain financial data contained in the Time of Sale Prospectus and the Prospectus, providing “management comfort” with
respect to such information, in form and substance reasonably satisfactory to the Representatives.
(l) Additional
Documents. On or before the Closing Date, the Representatives and counsel for the Underwriters shall have received such information,
documents and opinions as they may reasonably request for the purposes of enabling them to pass upon the issuance and sale of the Offered
Securities as contemplated herein, or in order to evidence the accuracy of any of the representations and warranties, or the satisfaction
of any of the conditions or agreements, herein contained; and all proceedings taken by the Company in connection with the issuance and
sale of the Offered Securities as contemplated herein and in connection with the other transactions contemplated by this Agreement shall
be satisfactory in form and substance to the Representatives and counsel for the Underwriters.
(m) Warrants.
The Representatives shall have received a form of Pre-Funded Warrant in form and substance reasonably acceptable to the Representatives.
If any condition
specified in this Section 6 is not satisfied when and as required to be satisfied, this
Agreement may be terminated by the Representatives by notice from the Representatives to the Company at any time on or prior to the Closing
Date, which termination shall be without liability on the part of any party to any other party, except that Section 4,
Section 7, Section 9 and Section 10
shall at all times be effective and shall survive such termination.
Section 7. Reimbursement
of Underwriters’ Expenses. If this Agreement is terminated by the Representatives pursuant to Section 6,
Section 11 or Section 12, or if the sale to the Underwriters of the Offered
Securities on the Closing Date is not consummated because of any refusal, inability or failure on the part of the Company to perform any
agreement herein or to comply with any provision hereof, the Company agrees to reimburse the Representatives and the other Underwriters
(or such Underwriters as have terminated this Agreement with respect to themselves), severally, upon demand for all documented out-of-pocket
expenses that shall have been reasonably incurred by the Representatives and the other Underwriters in connection with the proposed purchase
and the offering and sale of the Offered Securities, including, but not limited to, fees and disbursements of counsel, printing expenses,
travel expenses, postage, facsimile and telephone charges, subject to the limits contained in Sections 4(vi)-(viii). For the avoidance
of doubt, it is understood that the Company will not pay or reimburse any costs, fees or expenses incurred by any Underwriter that defaults
on its obligations to purchase the Offered Securities.
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Section 8. Effectiveness
of this Agreement. This Agreement shall become effective upon the execution and delivery hereof by the parties hereto.
Section 9. Indemnification.
(a) Indemnification
of the Underwriters. The Company agrees to indemnify and hold harmless each Underwriter, its affiliates, directors, officers,
employees and agents, and each person, if any, who controls any Underwriter within the meaning of the Securities Act or the Exchange Act
against any loss, claim, damage, liability or expense, as incurred, to which such Underwriter or such affiliate, director, officer, employee,
agent or controlling person may become subject, under the Securities Act, the Exchange Act, other federal or state statutory law or regulation,
or the laws or regulations of foreign jurisdictions where Offered Securities have been offered or sold or at common law or otherwise (including
in settlement of any litigation, if such settlement is effected with the written consent of the Company), insofar as such loss, claim,
damage, liability or expense (or actions in respect thereof as contemplated below) arises out of or is based upon (i) any untrue
statement or alleged untrue statement of a material fact contained in the Registration Statement, or any amendment thereto, or the omission
or alleged omission to state therein a material fact required to be stated therein or necessary to make the statements therein not misleading;
or (ii) any untrue statement or alleged untrue statement of a material fact included in the Time of Sale Prospectus, any free writing
prospectus that the Company has used, referred to or filed, or is required to file, pursuant to Rule 433(d) of the Securities
Act, any Marketing Material, any Written Testing-the-Waters Communication or the Prospectus (or any amendment or supplement to the foregoing),
or the omission or alleged omission to state therein a material fact necessary in order to make the statements, in the light of the circumstances
under which they were made, not misleading; or (iii) any act or failure to act or any alleged act or failure to act by any Underwriter
in connection with, or relating in any manner to, the Offered Securities or the offering contemplated hereby, and which is included as
part of or referred to in any loss, claim, damage, liability or action arising out of or based upon any matter covered by clause (i) or
(ii) above; and to reimburse each Underwriter and each such affiliate, director, officer, employee, agent and controlling person
for any and all expenses (including the fees and disbursements of counsel) as such expenses are incurred by such Underwriter or such affiliate,
director, officer, employee, agent or controlling person in connection with investigating, defending, settling, compromising or paying
any such loss, claim, damage, liability, expense or action; provided, however, that the foregoing indemnity agreement shall not
apply to any loss, claim, damage, liability or expense to the extent, but only to the extent, arising out of or based upon any untrue
statement or alleged untrue statement or omission or alleged omission made in reliance upon and in conformity with information relating
to any Underwriter furnished to the Company by the Representatives in writing expressly for use in the Registration Statement, the Time
of Sale Prospectus, any such free writing prospectus, any Marketing Material, any Written Testing-the-Waters Communication or the Prospectus
(or any amendment or supplement thereto), it being understood and agreed that the only such information consists of the information described
in Section 9(b) below. The indemnity agreement set forth in this Section 9(a) shall
be in addition to any liabilities that the Company may otherwise have.
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(b) Indemnification
of the Company, its Directors and Officers. Each Underwriter agrees, severally and not jointly, to indemnify and hold harmless
the Company, each of its directors, each of its officers who signed the Registration Statement and each person, if any, who controls the
Company within the meaning of the Securities Act or the Exchange Act, against any loss, claim, damage, liability or expense, as incurred,
to which the Company, or any such director, officer or controlling person may become subject, under the Securities Act, the Exchange Act,
or other federal or state statutory law or regulation, or at common law or otherwise (including in settlement of any litigation, if such
settlement is effected with the written consent of such Underwriter), insofar as such loss, claim, damage, liability or expense (or actions
in respect thereof as contemplated below) arises out of or is based upon (i) any untrue statement or alleged untrue statement of
a material fact contained in the Registration Statement, or any amendment thereto, or any omission or alleged omission to state therein
a material fact required to be stated therein or necessary to make the statements therein not misleading or (ii) any untrue statement
or alleged untrue statement of a material fact included in the Time of Sale Prospectus, any free writing prospectus that the Company has
used, referred to or filed, or is required to file, pursuant to Rule 433 of the Securities Act, any Written Testing-the-Waters Communication
or the Prospectus (or any such amendment or supplement) or the omission or alleged omission to state therein a material fact necessary
in order to make the statements, in the light of the circumstances under which they were made, not misleading, in each case to the extent,
but only to the extent, that such untrue statement or alleged untrue statement or omission or alleged omission was made in the Registration
Statement, the Time of Sale Prospectus, such free writing prospectus, such Written Testing-the-Waters Communication or the Prospectus
(or any such amendment or supplement), in reliance upon and in conformity with information relating to such Underwriter furnished to the
Company by the Representatives in writing expressly for use therein; and to reimburse the Company, or any such director, officer or controlling
person for any and all expenses (including the fees and disbursements of counsel) as such expenses are incurred by the Company, or any
such director, officer, or controlling person in connection with investigating, defending, settling, compromising or paying any such loss,
claim, damage, liability, expense or action. The Company hereby acknowledges that the only information that the Representatives have furnished
to the Company expressly for use in the Registration Statement, the Time of Sale Prospectus, any free writing prospectus that the Company
has filed, or is required to file, pursuant to Rule 433(d) of the Securities Act, any Written Testing-the-Waters Communication
or the Prospectus (or any amendment or supplement to the foregoing) are the statements set forth in the first sentence of the fourth paragraph
under the caption “Underwriting,” the first sentence of the first paragraph under the caption “Underwriting—Commission
and Expenses” and the first sentence of the first paragraph under the caption “Underwriting—Stabilization” in
the Prospectus. The indemnity agreement set forth in this Section 9(b) shall be in
addition to any liabilities that each Underwriter may otherwise have.
(c) Notifications
and Other Indemnification Procedures. Promptly after receipt by an indemnified party under this Section 9
of notice of the commencement of any action, such indemnified party will, if a claim in respect thereof is to be made against an indemnifying
party under this Section 9, notify the indemnifying party in writing of the commencement
thereof, but the omission to so notify the indemnifying party will not relieve the indemnifying party from any liability which it may
have to any indemnified party to the extent the indemnifying party is not materially prejudiced as a proximate result of such failure
and shall not in any event relieve the indemnifying party from any liability that it may have otherwise than on account of this indemnity
agreement. In case any such action is brought against any indemnified party and such indemnified party seeks or intends to seek indemnity
from an indemnifying party, the indemnifying party will be entitled to participate in, and, to the extent that it shall elect, jointly
with all other indemnifying parties similarly notified, by written notice delivered to the indemnified party promptly after receiving
the aforesaid notice from such indemnified party, to assume the defense thereof with counsel reasonably satisfactory to such indemnified
party; provided, however, that if the defendants in any such action include both the indemnified party and the indemnifying party
and the indemnified party shall have reasonably concluded that a conflict may arise between the positions of the indemnifying party and
the indemnified party in conducting the defense of any such action or that there may be legal defenses available to it and/or other indemnified
parties which are different from or additional to those available to the indemnifying party, the indemnified party or parties shall have
the right to select separate counsel to assume such legal defenses and to otherwise participate in the defense of such action on behalf
of such indemnified party or parties. Upon receipt of notice from the indemnifying party to such indemnified party of such indemnifying
party’s election to so assume the defense of such action and approval by the indemnified party of counsel, the indemnifying party
will not be liable to such indemnified party under this Section 9 for any legal or other
expenses subsequently incurred by such indemnified party in connection with the defense thereof unless (i) the indemnified party
shall have employed separate counsel in accordance with the proviso to the preceding sentence (it being understood, however, that the
indemnifying party shall not be liable for the fees and expenses of more than one separate counsel (together with local counsel), representing
the indemnified parties who are parties to such action), which counsel (together with any local counsel) for the indemnified parties shall
be selected by the Representatives (in the case of counsel for the indemnified parties referred to in Section 9(a) above) or
by the Company (in the case of counsel for the indemnified parties referred to in Section 9(b) above) or (ii) the indemnifying
party shall not have employed counsel satisfactory to the indemnified party to represent the indemnified party within a reasonable time
after notice of commencement of the action or (iii) the indemnifying party has authorized in writing the employment of counsel for
the indemnified party at the expense of the indemnifying party, in each of which cases the fees and expenses of counsel shall be at the
expense of the indemnifying party and shall be paid as they are incurred.
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(d) Settlements.
The indemnifying party under this Section 9 shall not be liable for any settlement of any
proceeding effected without its written consent, but if settled with such consent or if there be a final judgment for the plaintiff, the
indemnifying party agrees to indemnify the indemnified party against any loss, claim, damage, liability or expense by reason of such settlement
or judgment. Notwithstanding the foregoing sentence, if at any time an indemnified party shall have requested an indemnifying party to
reimburse the indemnified party for fees and expenses of counsel as contemplated by Section 9(c) hereof,
the indemnifying party shall be liable for any settlement of any proceeding effected without its written consent if (i) such settlement
is entered into more than 30 days after receipt by such indemnifying party of the aforesaid request and (ii) such indemnifying
party shall not have reimbursed the indemnified party in accordance with such request prior to the date of such settlement. No indemnifying
party shall, without the prior written consent of the indemnified party, effect any settlement, compromise or consent to the entry of
judgment in any pending or threatened action, suit or proceeding in respect of which any indemnified party is or could have been a party
and indemnity was or could have been sought hereunder by such indemnified party, unless such settlement, compromise or consent includes
an unconditional release of such indemnified party from all liability on claims that are the subject matter of such action, suit or proceeding
and does not include an admission of fault or culpability or a failure to act by or on behalf of such indemnified party.
Section 10. Contribution.
If the indemnification provided for in Section 9 is for any reason held to be unavailable
to or otherwise insufficient to hold harmless an indemnified party in respect of any losses, claims, damages, liabilities or expenses
referred to therein, then each indemnifying party shall contribute to the aggregate amount paid or payable by such indemnified party,
as incurred, as a result of any losses, claims, damages, liabilities or expenses referred to therein (i) in such proportion as is
appropriate to reflect the relative benefits received by the Company, on the one hand, and the Underwriters, on the other hand, from the
offering of the Offered Securities pursuant to this Agreement or (ii) if the allocation provided by clause (i) above is
not permitted by applicable law, in such proportion as is appropriate to reflect not only the relative benefits referred to in clause (i) above
but also the relative fault of the Company, on the one hand, and the Underwriters, on the other hand, in connection with the statements
or omissions which resulted in such losses, claims, damages, liabilities or expenses, as well as any other relevant equitable considerations.
The relative benefits received by the Company, on the one hand, and the Underwriters, on the other hand, in connection with the offering
of the Offered Securities pursuant to this Agreement shall be deemed to be in the same respective proportions as the total proceeds from
the offering of the Offered Securities pursuant to this Agreement (before deducting expenses) received by the Company, and the total underwriting
discounts and commissions received by the Underwriters, in each case as set forth on the front cover page of the Prospectus, bear
to the aggregate initial public offering price of the Offered Securities as set forth on such cover. The relative fault of the Company,
on the one hand, and the Underwriters, on the other hand, shall be determined by reference to, among other things, whether any such untrue
or alleged untrue statement of a material fact or omission or alleged omission to state a material fact relates to information supplied
by the Company, on the one hand, or the Underwriters, on the other hand, and the parties’ relative intent, knowledge, access to
information and opportunity to correct or prevent such statement or omission.
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The amount paid or
payable by a party as a result of the losses, claims, damages, liabilities and expenses referred to above shall be deemed to include,
subject to the limitations set forth in Section 9(c), any legal or other fees or expenses
reasonably incurred by such party in connection with investigating or defending any action or claim. The provisions set forth in Section 9(c) with
respect to notice of commencement of any action shall apply if a claim for contribution is to be made under this Section 10;
provided, however, that no additional notice shall be required with respect to any action for which notice has been given under
Section 9(c) for purposes of indemnification.
The Company and the
Underwriters agree that it would not be just and equitable if contribution pursuant to this Section 10
were determined by pro rata allocation (even if the Underwriters were treated as one entity for such purpose) or by any other method of
allocation which does not take account of the equitable considerations referred to in this Section 10.
Notwithstanding the
provisions of this Section 10, no Underwriter shall be required to contribute any amount
in excess of the underwriting discounts and commissions received by such Underwriter in connection with the Offered Securities underwritten
by it and distributed to the public. No person guilty of fraudulent misrepresentation (within the meaning of Section 11(f) of
the Securities Act) shall be entitled to contribution from any person who was not guilty of such fraudulent misrepresentation. The Underwriters’
obligations to contribute pursuant to this Section 10 are several, and not joint, in proportion
to their respective underwriting commitments as set forth opposite their respective names on Schedule A. For purposes of this Section 10,
each affiliate, director, officer, employee and agent of an Underwriter and each person, if any, who controls an Underwriter within the
meaning of the Securities Act or the Exchange Act shall have the same rights to contribution as such Underwriter, and each director of
the Company, each officer of the Company who signed the Registration Statement, and each person, if any, who controls the Company within
the meaning of the Securities Act and the Exchange Act shall have the same rights to contribution as the Company.
Section 11. Default
of One or More of the Several Underwriters. If, on the Closing Date any one or more of the several Underwriters shall fail
or refuse to purchase Offered Securities that it or they have agreed to purchase hereunder on such date, and the aggregate number of Offered
Securities which such defaulting Underwriter or Underwriters agreed but failed or refused to purchase does not exceed 10% of the aggregate
number of the Offered Securities to be purchased on such date, the Representatives may make arrangements satisfactory to the Company for
the purchase of such Offered Securities by other persons, including any of the Underwriters, but if no such arrangements are made by such
date, the other Underwriters shall be obligated, severally and not jointly, in the proportions that the number of Offered Shares and Pre-Funded
Warrants set forth opposite their respective names on Schedule A bears to the aggregate number of Offered Shares and Pre-Funded
Warrants set forth opposite the names of all such non-defaulting Underwriters, or in such other proportions as may be specified by the
Representatives with the consent of the non-defaulting Underwriters, to purchase the Offered Securities which such defaulting Underwriter
or Underwriters agreed but failed or refused to purchase on such date. If, on the Closing Date any one or more of the Underwriters shall
fail or refuse to purchase Offered Securities and the aggregate number of Offered Securities with respect to which such default occurs
exceeds 10% of the aggregate number of Offered Securities to be purchased on such date, and arrangements satisfactory to the Representatives
and the Company for the purchase of such Offered Securities are not made within 48 hours after such default, this Agreement shall terminate
without liability of any party to any other party except that the provisions of Section 4,
Section 7, Section 9 and Section 10
shall at all times be effective and shall survive such termination. In any such case either the Representatives or the Company shall have
the right to postpone the Closing Date, but in no event for longer than seven days in order that the required changes, if any, to the
Registration Statement and the Prospectus or any other documents or arrangements may be effected.
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As used in this Agreement,
the term “Underwriter” shall be deemed to include any person substituted for a defaulting Underwriter under this Section 11.
Any action taken under this Section 11 shall not relieve any defaulting Underwriter from
liability in respect of any default of such Underwriter under this Agreement.
Section 12. Termination
of this Agreement. Prior to the purchase of the Offered Securities by the Underwriters on the Closing Date, this Agreement
may be terminated by the Representatives by notice given to the Company if at any time: (i) trading or quotation in any of the Company’s
securities shall have been suspended or limited by the Commission or by the Nasdaq, or trading in securities generally on either the Nasdaq
or the NYSE shall have been suspended or limited, or minimum or maximum prices shall have been generally established on any of such stock
exchanges; (ii) a general banking moratorium shall have been declared by any of federal, New York, or Pennsylvania authorities; (iii) there
shall have occurred any outbreak or escalation of national or international hostilities or any crisis or calamity, or any change in the
United States or international financial markets, or any substantial change or development involving a prospective substantial change
in United States’ or international political, financial or economic conditions, as in the judgment of the Representatives is material
and adverse and makes it impracticable to market the Offered Securities in the manner and on the terms described in the Time of Sale Prospectus
or the Prospectus or to enforce contracts for the sale of securities; (iv) in the judgment of the Representatives there shall have
occurred any Material Adverse Change; or (v) the Company shall have sustained a loss by strike, fire, flood, earthquake, accident
or other calamity of such character as in the judgment of the Representatives may interfere materially with the conduct of the business
and operations of the Company regardless of whether or not such loss shall have been insured. Any termination pursuant to this Section 12
shall be without liability on the part of (a) the Company to any Underwriter, except that the Company shall be obligated to reimburse
the expenses of the Representatives and the other Underwriters pursuant to Section 4
or Section 7 hereof or (b) any Underwriter to the Company; provided, however,
that the provisions of Section 9 and Section 10
shall at all times be effective and shall survive such termination.
Section 13. No
Advisory or Fiduciary Relationship. The Company acknowledges and agrees that (a) the purchase and sale of the Offered Securities
pursuant to this Agreement, including the determination of the public offering price of the Offered Securities and any related discounts
and commissions, is an arm’s-length commercial transaction between the Company, on the one hand, and the several Underwriters, on
the other hand, (b) in connection with the offering contemplated hereby and the process leading to such transaction, each Underwriter
is and has been acting solely as a principal and is not the agent or fiduciary of the Company, or its stockholders, creditors, employees
or any other party, (c) no Underwriter has assumed or will assume an advisory or fiduciary responsibility in favor of the Company
with respect to the offering contemplated hereby or the process leading thereto (irrespective of whether such Underwriter has advised
or is currently advising the Company on other matters) and no Underwriter has any obligation to the Company with respect to the offering
contemplated hereby except the obligations expressly set forth in this Agreement, (d) the Underwriters and their respective affiliates
may be engaged in a broad range of transactions that involve interests that differ from those of the Company, and (e) the Underwriters
have not provided any legal, accounting, regulatory or tax advice with respect to the offering contemplated hereby and the Company has
consulted its own legal, accounting, regulatory and tax advisors to the extent it deemed appropriate.
-31-
Section 14. Representations
and Indemnities to Survive Delivery. The respective indemnities, agreements, representations, warranties and other statements
of the Company, of its officers and of the several Underwriters set forth in or made pursuant to this Agreement will remain in full force
and effect, regardless of any investigation made by or on behalf of any Underwriter or the Company or any of its or their partners, officers
or directors or any controlling person, as the case may be, and, anything herein to the contrary notwithstanding, will survive delivery
of and payment for the Offered Securities sold hereunder and any termination of this Agreement.
Section 15. Notices.
All communications hereunder shall be in writing and shall be mailed, hand delivered or telecopied and confirmed to the parties hereto
as follows:
If to the Representatives:
Leerink Partners LLC
1301 Avenue of the Americas, 5th Floor
New York, New York 10019
Attention: Stuart R. Nayman
Piper Sandler & Co.
350 North 5th Street, Suite 1000
Minneapolis, Minnesota 55401
Attention: General Counsel
Cantor Fitzgerald & Co.
110 East 59th Street
New York, New York 10022
Facsimile: (212) 829-4708
Attention: General Counsel
with a copy to:
Covington & Burling LLP
30 Hudson Yards
New York, New York 10001
Attention: Brian K. Rosenzweig
If to the Company:
Aclaris Therapeutics, Inc.
701 Lee Road, Suite 103
Wayne, Pennsylvania 19087
Attention: Legal Department
E-mail:
with a copy to:
Cooley LLP
11951 Freedom Drive, 14th Floor
Reston, Virginia 20190-5640
Facsimile: (703) 456-8100
Attention: Mark Ballantyne, Esq.
E-mail:
Any party hereto may change the address for receipt of communications
by giving written notice to the others.
-32-
Section 16. Successors.
This Agreement will inure to the benefit of and be binding upon the parties hereto, including any substitute Underwriters pursuant to
Section 11 hereof, and to the benefit of the affiliates, directors, officers, employees,
agents and controlling persons referred to in Section 9 and Section 10,
and in each case their respective successors, and no other person will have any right or obligation hereunder. The term “successors”
shall not include any purchaser of the Offered Securities as such from any of the Underwriters merely by reason of such purchase.
Section 17. Partial
Unenforceability. The invalidity or unenforceability of any section, paragraph or provision of this Agreement shall not affect the
validity or enforceability of any other section, paragraph or provision hereof. If any section, paragraph or provision of this Agreement
is for any reason determined to be invalid or unenforceable, there shall be deemed to be made such minor changes (and only such minor
changes) as are necessary to make it valid and enforceable.
Section 18. Recognition
of the U.S. Special Resolution Regimes.
(a) In
the event that any Underwriter that is a Covered Entity becomes subject to a proceeding under a U.S. Special Resolution Regime, the transfer
from such Underwriter of this Agreement, and any interest and obligation in or under this Agreement, will be effective to the same extent
as the transfer would be effective under the U.S. Special Resolution Regime if this Agreement, and any such interest and obligation, were
governed by the laws of the United States or a state of the United States.
(b) In
the event that any Underwriter that is a Covered Entity or a BHC Act Affiliate of such Underwriter becomes subject to a proceeding under
a U.S. Special Resolution Regime, Default Rights under this Agreement that may be exercised against such Underwriter are permitted to
be exercised to no greater extent than such Default Rights could be exercised under the U.S. Special Resolution Regime if this Agreement
were governed by the laws of the United States or a state of the United States.
For purposes of this Agreement, (A) “BHC Act Affiliate”
has the meaning assigned to the term “affiliate” in, and shall be interpreted in accordance with, 12 U.S.C. § 1841(k);
(B) “Covered Entity” means any of the following: (i) a “covered entity” as that term is defined
in, and interpreted in accordance with, 12 C.F.R. § 252.82(b); (ii) a “covered bank” as that term is defined in,
and interpreted in accordance with, 12 C.F.R. § 47.3(b); or (iii) a “covered FSI” as that term is defined in, and
interpreted in accordance with, 12 C.F.R. § 382.2(b); (C) “Default Right” has the meaning assigned to that
term in, and shall be interpreted in accordance with, 12 C.F.R. §§ 252.81, 47.2 or 382.1, as applicable; and (D) “U.S.
Special Resolution Regime” means each of (i) the Federal Deposit Insurance Act and the regulations promulgated thereunder
and (ii) Title II of the Dodd-Frank Wall Street Reform and Consumer Protection Act and the regulations promulgated thereunder.
Section 19. Governing
Law Provisions. This Agreement shall be governed by and construed in accordance with the internal laws of the State of New
York applicable to agreements made and to be performed in such state. Any legal suit, action or proceeding arising out of or based upon
this Agreement or the transactions contemplated hereby may be instituted in the federal courts of the United States of America located
in the Borough of Manhattan in the City of New York or the courts of the State of New York in each case located in the Borough of Manhattan
in the City of New York (collectively, the “Specified Courts”), and each party irrevocably submits to the exclusive
jurisdiction (except for proceedings instituted in regard to the enforcement of a judgment of any such court, as to which such jurisdiction
is non-exclusive) of such courts in any such suit, action or proceeding. Service of any process, summons, notice or document by mail to
such party’s address set forth above shall be effective service of process for any suit, action or other proceeding brought in any
such court. The parties irrevocably and unconditionally waive any objection to the laying of venue of any suit, action or other proceeding
in the Specified Courts and irrevocably and unconditionally waive and agree not to plead or claim in any such court that any such suit,
action or other proceeding brought in any such court has been brought in an inconvenient forum.
-33-
Section 20. General
Provisions. This Agreement constitutes the entire agreement of the parties to this Agreement and supersedes all prior written or oral
and all contemporaneous oral agreements, understandings and negotiations with respect to the subject matter hereof. This Agreement may
be executed in two or more counterparts, each one of which shall be an original, with the same effect as if the signatures thereto and
hereto were upon the same instrument, provided that a facsimile or pdf signature including any electronic signatures complying with the
U.S. federal ESIGN Act of 2000, e.g., www.docusign.com shall be considered due execution and shall be binding upon the signatory thereto
with the same force and effect as if the signature were an original, not a facsimile or pdf (or other electronic reproduction of a) signature.
This Agreement may not be amended or modified unless in writing by all of the parties hereto, and no condition herein (express or implied)
may be waived unless waived in writing by each party whom the condition is meant to benefit. The section headings herein are for the convenience
of the parties only and shall not affect the construction or interpretation of this Agreement.
Each of the parties
hereto acknowledges that it is a sophisticated business person who was adequately represented by counsel during negotiations regarding
the provisions hereof, including, without limitation, the indemnification provisions of Section 9
and the contribution provisions of Section 10, and is fully informed regarding said provisions.
Each of the parties hereto further acknowledges that the provisions of Section 9 and Section 10
hereof fairly allocate the risks in light of the ability of the parties to investigate the Company, its affairs and its business in order
to assure that adequate disclosure has been made in the Registration Statement, the Time of Sale Prospectus, each free writing prospectus
and the Prospectus (and any amendments and supplements to the foregoing), as contemplated by the Securities Act and the Exchange Act.
-34-
If the foregoing is in accordance with your understanding
of our agreement, kindly sign and return to the Company the enclosed copies hereof, whereupon this instrument, along with all counterparts
hereof, shall become a binding agreement in accordance with its terms.
Very truly yours,
ACLARIS THERAPEUTICS, INC.
By:
/s/ Neal Walker
Name:
Neal Walker
Title:
Chief Executive Officer
The foregoing Underwriting Agreement is hereby
confirmed and accepted by the Representatives in New York, New York as of the date first above written.
LEERINK PARTNERS LLC
PIPER SANDLER & CO.
CANTOR FITZGERALD & CO.
For themselves and as Representatives of the several Underwriters
named in Schedule A hereto.
LEERINK PARTNERS LLC
By:
/s/ Dan Dubin
Name:
Dan Dubin, M.D.
Title:
Vice Chairman, Head of BioPharma Investment
Banking
PIPER SANDLER & CO.
By:
/s/ Paul Scansaroli
Name:
Paul Scansaroli
Title:
Managing Director
CANTOR FITZGERALD & CO.
By:
/a/ Asif Ahmed
Name:
Asif Ahmed
Title:
Managing Director
[Signature Page to Underwriting
Agreement]
Schedule A
Underwriters
Number of
Offered Shares
to be Purchased
Number of Pre-
Funded Warrants
to be Purchased
Leerink Partners LLC
2,958,571
2,470,000
Piper Sandler & Co.
2,102,143
1,755,000
Cantor Fitzgerald & Co.
2,024,286
1,690,000
LifeSci Capital LLC
700,714
585,000
Total
7,785,714
6,500,000
Schedule B
Free Writing Prospectuses Included in the
Time of Sale Prospectus
None.
Schedule C
Permitted Testing-the-Waters Communications
None.
Exhibit A
Form of Lock-up Agreement
October [●], 2026
Leerink Partners LLC
Piper Sandler & Co.
Cantor Fitzgerald & Co.
As Representatives of the several Underwriters
c/o Leerink Partners LLC
1301 Avenue of the Americas, 5th Floor
New York, New York 10019
c/o Piper Sandler & Co.
350 North 5th Street, Suite 1000
Minneapolis, Minnesota 55401
c/o Cantor Fitzgerald & Co.
110 East 59th Street
New York, New York 10022
RE: Aclaris Therapeutics, Inc.
(the “Company”)
Ladies & Gentlemen:
The undersigned is an owner of shares of common
stock, par value $0.00001 per share, of the Company (“Shares”) or of securities convertible into or exchangeable or
exercisable for Shares (together with Shares, “Securities”). The Company proposes to conduct an offering of Securities
(the “Offering”) for which Leerink Partners LLC, Piper Sandler & Co. and Cantor Fitzgerald & Co.
(together, the “Representatives”) will act as the representatives of the underwriters. The undersigned recognizes that
the Offering will benefit each of the Company and the undersigned. The undersigned acknowledges that the underwriters are relying on the
representations and agreements of the undersigned contained in this letter agreement in conducting the Offering and, at a subsequent date,
in entering into an underwriting agreement (the “Underwriting Agreement”) and other underwriting arrangements with
the Company with respect to the Offering.
Annex A sets forth definitions for capitalized
terms used in this letter agreement that are not defined in the body of this letter agreement. Those definitions are a part of this letter
agreement.
In consideration of the foregoing, and for other
good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the undersigned hereby agrees that, during
the Lock-up Period, the undersigned will not (and will cause any Family Member not to), without the prior written consent of the Representatives,
which may withhold their consent in their sole discretion:
3
· Sell
or Offer to Sell any Shares or Related Securities currently or hereafter owned either of
record or beneficially (as defined in Rule 13d-3 under the Exchange Act) by the undersigned
[(which shall not include Aisling Shares (as defined below)] or such Family Member,
· enter into any Swap,
· make any demand for, or exercise any right with
respect to, the registration under the Securities Act of the offer and sale of any Shares or Related Securities, or cause to be filed
a registration statement, prospectus or prospectus supplement (or an amendment or supplement thereto) with respect to any such registration,
or
· publicly announce any intention to do any of
the foregoing.
[For purposes of this letter agreement, in no event
shall Shares or Related Securities include any shares owned either of record or beneficially directly or indirectly by Aisling Capital
IV, LP or any affiliate thereof (the “Aisling Shares”), and in no event shall the Aisling Shares be restricted by,
or subject to, this letter agreement.]
The foregoing will not apply to the registration
of the offer and sale of the Securities, and the sale of the Securities to the underwriters, in each case as contemplated by the Underwriting
Agreement. In addition, the foregoing will not apply to:
(i) the transfer of Shares or Related Securities by gift or by will or intestate succession to the legal representative,
heir, beneficiary or any Family Member or to a trust whose beneficiaries consist exclusively of one or more of the undersigned and/or
Family Member(s);
(ii) transfers or dispositions of the undersigned’s Shares or Related Securities to any corporation,
partnership, limited liability company or other entity all of the beneficial ownership interests of which are held by the undersigned
or any Family Member;
(iii) distributions of the undersigned’s Shares or Related Securities to partners, members, stockholders
or other equityholders of the undersigned, provided that any such transfer or distribution shall not involve a disposition of value;
(iv) the transfer of Shares or Related Securities by operation of law, including pursuant to a domestic order
or negotiated divorce settlement;
(v) the exercise of options to purchase Shares granted under any equity incentive plan or stock purchase plan
of the Company, existing as of the date hereof and described in the Prospectus, provided that the underlying Shares shall continue to
be subject to the restrictions on transfer set forth in this letter agreement;
(vi) the establishment of a trading plan pursuant to Rule 10b5-1 under the Exchange Act for the transfer
of Shares, provided that such plan does not provide for any transfers of Shares or Related Securities during the Lock-up Period;
(vii) subject to the provisions below regarding stop transfer instructions with the Company’s transfer
agent and registrar, the transfer or disposal of Shares acquired in the open market following the Offering; and
4
(viii) the transfer of Shares (A) to the Company as forfeitures to satisfy tax withholding obligations of
the undersigned in connection with the vesting or exercise of equity awards by the undersigned pursuant to the Company’s equity
incentive plans existing as of the date hereof and described in the Prospectus, (B) pursuant to a net exercise or cashless exercise
by the undersigned of outstanding equity awards pursuant to the Company’s equity incentive plans existing as of the date hereof
and described in the Prospectus, including any transfer of Shares to the Company for the payment of tax withholdings or remittance payments
due as a result of the vesting, settlement or exercise of such equity awards, or sales of Shares pursuant to a “sell-to-cover” arrangement
upon the vesting, settlement or exercise of such equity awards solely to cover tax withholding obligations in connection with such transaction
and any transfer of Shares to the Company for the payment of taxes as a result of such transaction, provided that any Shares acquired
upon the net exercise or cashless exercise of equity awards described in this clause (B) shall be subject to the restrictions set
forth in this letter agreement, or (C) pursuant to a bona fide third-party tender offer for all outstanding shares of the Company,
merger, consolidation or other similar transaction made to all holders of the Company’s securities involving a change of control
of the Company (including, without limitation, the entering into any lock-up, voting or similar agreement pursuant to which the undersigned
may agree to transfer, sell, tender or otherwise dispose of common stock or other such securities in connection with such transaction,
or vote any common stock or other such securities in favor of any such transaction), provided that in the event that such tender offer,
merger, consolidation or other such transaction is not completed, such securities held by the undersigned shall remain subject to the
provisions of this letter agreement, provided that, in the case of a transfer pursuant to clause (A) or (B) above, if the undersigned
is required to make a filing under the Exchange Act reporting a reduction in beneficial ownership of Shares during the Lock-up Period,
the undersigned shall include a statement in such report to the effect that the purpose of such transfer was to cover tax obligations
of the undersigned in connection with such exercise;
provided, however, that (A) in
any such case, it shall be a condition to a transfer pursuant to subparagraphs (i), (ii), (iii) and (iv) that each transferee
executes and delivers to the Representatives an agreement in form and substance satisfactory to the Representatives stating that such
transferee is receiving and holding such Shares and/or Related Securities subject to the provisions of this letter agreement and agrees
not to Sell or Offer to Sell such Shares and/or Related Securities, engage in any Swap or engage in any other activities restricted under
this letter agreement except in accordance with this letter agreement (as if such transferee had been an original signatory hereto), and
(B) in any such case it shall be a condition to a transfer that prior to the expiration of the Lock-up Period, no public disclosure
or filing under the Exchange Act by any party to the transfer (donor, donee, transferor or transferee) shall be required, or made voluntarily,
reporting a reduction in beneficial ownership of Shares in connection with such transfer, except as provided in subparagraph (viii) above.
The undersigned also agrees and consents to the
entry of stop transfer instructions with the Company’s transfer agent and registrar against the transfer of Shares and/or Related
Securities held by the undersigned and the undersigned’s Family Members, if any, except in compliance with the foregoing restrictions.
With respect to the Offering only, the undersigned
waives any registration rights relating to registration under the Securities Act of the offer and sale of any Shares and/or any Related
Securities owned either of record or beneficially by the undersigned, including any rights to receive notice of the Offering.
5
The undersigned confirms that the undersigned
has not, and has no knowledge that any Family Member has, directly or indirectly, taken any action designed to or that might reasonably
be expected to cause or result in the stabilization or manipulation of the price of any security of the Company to facilitate the sale
of the Shares. The undersigned will not, and will cause any Family Member not to take, directly or indirectly, any such action.
The undersigned acknowledges and agrees that the
underwriters have not provided any recommendation or investment advice nor have the underwriters solicited any action from the undersigned
with respect to the Offering and the undersigned has consulted their own legal, accounting, financial, regulatory and tax advisors to
the extent deemed appropriate.
Whether or not the Offering occurs as currently
contemplated or at all depends on market conditions and other factors. The Offering will only be made pursuant to the Underwriting Agreement,
the terms of which are subject to negotiation between the Company and the underwriters.
The undersigned hereby represents and warrants
that the undersigned has full power, capacity and authority to enter into this letter agreement. This letter agreement is irrevocable
and will be binding on the undersigned and the successors, heirs, personal representatives and assigns of the undersigned.
This letter agreement may be delivered via facsimile,
electronic mail (including pdf or any electronic signature complying with the U.S. federal ESIGN Act of 2000, e.g., www.docusign.com or
www.echosign.com) or other transmission method and any counterpart so delivered shall be deemed to have been duly and validly delivered
and be valid and effective for all purposes.
This letter agreement shall be governed by, and
construed in accordance with, the laws of the State of New York.
If (i) the Company notifies the Representatives
in writing that it does not intend to proceed with the Offering, (ii) the Underwriting Agreement is not executed before November 15,
2026, or (iii) the Underwriting Agreement (other than the provisions thereof that survive termination) terminates or is terminated
prior to payment for and delivery of the Offered Securities (as defined in the Underwriting Agreement), then in each case, this letter
agreement shall automatically, and without any action on the part of any other party, terminate and be of no further force and effect,
and the undersigned shall automatically be released from the obligations under this letter agreement.
6
Signature
Printed Name of Person Signing
(Indicate capacity of person signing if signing as custodian or trustee, or on behalf of an entity)
[Signature Page to Lock-up Agreement]
Annex A
Certain Defined Terms
Used in Lock-up Agreement
For purposes of the letter agreement to which
this Annex A is attached and of which it is made a part:
· “Call Equivalent Position”
shall have the meaning set forth in Rule 16a-1(b) under the Exchange Act.
· “Exchange Act” shall mean
the Securities Exchange Act of 1934, as amended.
· “Family Member” shall mean
the spouse of the undersigned, an immediate family member of the undersigned or an immediate family member of the undersigned’s
spouse, in each case living in the undersigned’s household or whose principal residence is the undersigned’s household (regardless
of whether such spouse or family member may at the time be living elsewhere due to educational activities, health care treatment, military
service, temporary internship or employment or otherwise). “Immediate family member” as used above shall have the meaning
set forth in Rule 16a-1(e) under the Exchange Act.
· “Lock-up Period” shall mean
the period beginning on the date hereof and continuing through the close of trading on the date that is 60 days after the date of the
Prospectus (as defined in the Underwriting Agreement).
· “Put Equivalent Position”
shall have the meaning set forth in Rule 16a-1(h) under the Exchange Act.
· “Related Securities” shall
mean any options or warrants or other rights to acquire Shares or any securities exchangeable or exercisable for or convertible into Shares,
or to acquire other securities or rights ultimately exchangeable or exercisable for or convertible into Shares.
· “Securities Act” shall mean
the Securities Act of 1933, as amended.
· “Sell or Offer to Sell” shall
mean to:
– sell, offer to sell, contract to sell or lend,
– effect any short sale or establish or increase a Put Equivalent Position or liquidate or decrease any
Call Equivalent Position,
– pledge, hypothecate or grant any security interest in, or
– in any other way transfer or dispose of,
in each case whether
effected directly or indirectly.
· “Swap” shall mean any swap,
hedge or similar arrangement or agreement that transfers, in whole or in part, the economic risk of ownership of Shares or Related Securities,
regardless of whether any such transaction is to be settled in securities, in cash or otherwise.
Capitalized terms not defined in this Annex A
shall have the meanings given to them in the body of this lock-up agreement.
Exhibit B
Directors and Officers
Directors:
Neal Walker
Christopher Molineaux
Hugh Davis
Maxine Gowen
William Humphries
Anand Mehra
Vincent Milano
Andrew Schiff
Officers:
Neal Walker
Kevin Balthaser
Hugh Davis
Jesse Hall
Roland Kolbeck
James Loerop
EX-4.1 — EXHIBIT 4.1
EX-4.1
Filename: tm2628355d1_ex4-1.htm · Sequence: 3
Exhibit 4.1
PRE-FUNDED COMMON STOCK PURCHASE WARRANT
ACLARIS THERAPEUTICS, INC.
Warrant Shares:
Date of Issuance: ,
2026 (such date, the “Issue Date”)
Warrant No.: PF-[ ]
THIS PRE-FUNDED COMMON STOCK PURCHASE WARRANT
(the “Warrant”) certifies that, for value received, the registered holder hereof or its permitted assigns (the “Holder”)
is entitled, upon the terms and subject to the limitations on exercise and the conditions set forth herein, at any time on or after the
Issue Date, to subscribe for and purchase from Aclaris Therapeutics, Inc., a Delaware corporation (the “Company”),
up to shares
(the “Warrant Shares”) of the Company’s common stock, par value $0.00001 per share (“Common Stock”).
The purchase price of one share of Common Stock under this Warrant shall be equal to the Exercise Price, as defined in Section 2(b).
This Warrant has been issued pursuant to (i) the terms of the Underwriting Agreement, dated October [•], 2026, among the
Company on the one hand and, on the other, Leerink Partners LLC, Piper Sandler & Co. and Cantor Fitzgerald & Co., as
representatives of the several underwriters named therein, (ii) the Company’s registration statement on Form S-3 (Commission
File No. 333-298084) and (iii) the Company’s prospectus supplement dated as of October [•], 2026.
Section 1. Definitions. For
purposes of this Warrant, the following terms shall have the following meanings:
(a) “Affiliate” means
any Person that, directly or indirectly through one or more intermediaries, controls or is controlled by or is under common control with
a Person, as such terms are used in and construed under Rule 405 under the Securities Act of 1933, as amended (the “1933
Act”).
(b) “Attribution Parties”
means, collectively, the following Persons and entities: (i) any investment vehicle, including any funds, feeder funds or managed
accounts, currently, or from time to time after the Issue Date, directly or indirectly managed or advised by the Holder’s investment
manager, (ii) any direct or indirect Affiliates of the Holder or any of the foregoing, (iii) any Person acting or who could
be deemed to be acting as a Group together with the Holder or any of the foregoing and (iv) any other Persons whose beneficial ownership
of Common Stock would or could be aggregated with the Holder’s and the other Attribution Parties for purposes of Section 13(d) or
Section 16 of the Securities Exchange Act of 1934, as amended (the “1934 Act”). For clarity, the purpose of the
foregoing is to subject collectively the Holder and all other Attribution Parties to the Maximum Percentage (as defined in Section 2(e)).
(c) “Business Day” means
any day except any Saturday, any Sunday, any day that is a federal legal holiday in the United States or any day on which banking institutions
in the city of New York, New York are authorized or required by law or other governmental action to remain closed.
(d) “Closing Sale Price”
means, for any security as of any date, the last trade price for such security on the Trading Market for such security, as reported by
the Trading Market, or, if such Trading Market begins to operate on an extended hours basis and does not designate the last trade price,
then the last trade price of such security prior to 4:00 P.M., New York City time, as reported by Bloomberg Financial Markets, or if
the foregoing do not apply, the last trade price of such security in the over-the-counter market on the electronic bulletin board for
such security as reported by Bloomberg Financial Markets. If the Closing Sale Price cannot be calculated for a security on a particular
date on any of the foregoing bases, the Closing Sale Price of such security on such date shall be the fair market value as mutually determined
by the Company and the Holder. If the Company and the Holder are unable to agree upon the fair market value of such security, then the
Board of Directors of the Company shall use its good faith judgment to determine the fair market value. The Board of Directors’
determination shall be binding upon all parties absent demonstrable error. All such determinations shall be appropriately adjusted for
any stock dividend, stock split, stock combination or other similar transaction during the applicable calculation period..
(e) “Group” means a “group”
as that term is used in Section 13(d) of the 1934 Act and as defined in Rule 13d-5 thereunder.
(f) “Person” means an
individual, a limited liability company, a partnership, a joint venture, a corporation, a trust, an unincorporated organization, any
other entity and a government or any department or agency thereof.
1
(g) “Standard Settlement Period”
means the standard settlement period, expressed in a number of Trading Days, for the Trading Market with respect to the Common Stock
that is in effect on the date of delivery of an applicable Notice of Exercise, which as of the Issue Date was “T+1.”
(h) “Trading Day” means
any day on which the Common Stock is traded on the Trading Market.
(i) “Trading Market”
means the principal securities exchange or securities market, including an over-the-counter market, on which the Common Stock is then
traded in the United States.
Section 2. Exercise.
(a) Exercise of Warrant. Subject
to the terms and conditions hereof, the purchase rights represented by this Warrant may be exercised, in whole or in part, at any time
or times on or after the Issue Date by delivery (whether via email or otherwise) to the Company (or such other office or agency of the
Company as it may designate by notice in writing to the registered Holder at the address of the Holder appearing on the books of the
Company) of a duly executed copy of the Notice of Exercise form annexed hereto (the “Notice of Exercise”) and by payment
to the Company of an amount equal to the aggregate Exercise Price of the Warrant Shares thereby purchased by wire transfer (or by notifying
the Company that this Warrant is being exercised pursuant to a Cashless Exercise (as defined below)). No ink-original Notice of Exercise
shall be required, nor shall any medallion guarantee (or other type of guarantee or notarization) of any Notice of Exercise form be required.
The Holder shall not be required to deliver the original Warrant in order to effect an exercise hereunder. Execution and delivery of
the Notice of Exercise Notice shall have the same effect as cancellation of the original Warrant and issuance of a new Warrant evidencing
the right to purchase the remaining number of Warrant Shares, if any. The Holder and the Company shall maintain records showing the number
of Warrant Shares purchased and the date of such purchases. The Holder and any assignee, by acceptance of this Warrant, acknowledge
and agree that, by reason of the provisions of this paragraph, following the purchase of a portion of the Warrant Shares hereunder, the
number of Warrant Shares available for purchase hereunder at any given time may be less than the amount stated on the face hereof.
(b) Exercise Price. The
aggregate exercise price of this Warrant, except for a nominal exercise price of $0.00001 per Warrant Share (subject to adjustment as
provided herein), was pre-funded to the Company on or prior to the Issue Date and, consequently, no additional consideration
(other than such nominal exercise price) shall be required to be paid by the Holder to effect any exercise of this Warrant. The Holder
shall not be entitled to the return or refund of all, or any portion, of such pre-paid aggregate exercise price under any circumstance
or for any reason whatsoever. The remaining unpaid exercise price per Warrant Share shall be $0.00001, subject to adjustment as provided
herein (the “Exercise Price”).
(c) Mechanics of Exercise.
(i). Delivery of Warrant Shares Upon Exercise.
Warrant Shares purchased hereunder shall be transmitted to the Holder by crediting the account of the Holder’s prime broker with
The Depository Trust Company (“DTC”) through its Deposit/Withdrawal at Custodian (“DWAC”) system
if the Company is then a participant in such system and either (A) there is an effective registration statement permitting the issuance
of the Warrant Shares to or resale of the Warrant Shares by the Holder or (B) the Warrant Shares are eligible for resale by the
Holder without volume or manner-of-sale limitations pursuant to Rule 144 (assuming cashless exercise of the Warrant), and otherwise
in book-entry form via a direct registration system (“DRS”) maintained by or on behalf of the Company’s transfer
agent no later than the number of Trading Days comprising the Standard Settlement Period after the receipt by the Company of the Notice
of Exercise (provided that payment of the Exercise Price (or notification of Cashless Exercise, if applicable) has then been received
by the Company) (such date, the “Warrant Share Delivery Date”). This Warrant shall be deemed to have been exercised
upon proper delivery of the Notice of Exercise and payment of the Exercise Price (or notification of Cashless Exercise). The Warrant
Shares shall be deemed to have been issued, and the Holder or any other person so designated to be named therein shall be deemed to have
become a holder of record of such shares for all purposes, as of the date the Warrant has been exercised. The Company shall use commercially
reasonable efforts to maintain a transfer agent that is a participant in the FAST program so long as this Warrant remains outstanding
and exercisable.
(ii). Delivery of New Warrant Upon Exercise.
If this Warrant shall have been exercised in part, the Company shall, at the request of a Holder, at the time of delivery of the certificate
or certificates representing Warrant Shares, deliver to the Holder a new Warrant evidencing the rights of the Holder to purchase the
unpurchased Warrant Shares called for by this Warrant, which new Warrant shall in all other respects be identical to this Warrant.
2
(iii). Compensation for Buy-In on Failure
to Timely Deliver Warrant Shares Upon Exercise. In addition to any other rights available to the Holder, if the Company fails to
cause its transfer agent to transmit to the Holder the Warrant Shares in accordance with the provisions of Section 2(c)(i) pursuant
to an exercise on or before the Warrant Share Delivery Date (other than a failure caused by incorrect or incomplete information provided
by the Holder to the Company), and if after such date the Holder is required by its broker to purchase (in an open market transaction
or otherwise) or the Holder’s brokerage firm otherwise purchases, shares of Common Stock to deliver in satisfaction of a sale by
the Holder of the Warrant Shares which the Holder anticipated receiving upon such exercise (a “Buy-In”), then the
Company shall promptly, and in any event within two (2) Business Days of receipt of notice from the Holder of the occurrence of
a Buy-In, either (A) pay in cash to the Holder the amount, if any, by which (x) the Holder’s total purchase price (including
brokerage commissions, if any) for the shares of Common Stock so purchased exceeds (y) the amount obtained by multiplying (1) the
number of Warrant Shares that the Company was required to deliver to the Holder in connection with the exercise at issue times (2) the
price at which the sell order giving rise to such purchase obligation was executed, or (B) at the option of the Holder, either reinstate
the portion of the Warrant an equivalent number of Warrant Shares for which such exercise was not honored (in which case such exercise
shall be deemed rescinded) or deliver to the Holder the number of shares of Common Stock that would have been issued had the Company
timely complied with its exercise and delivery obligations hereunder. For example, if the Holder purchases Common Stock having a total
purchase price of $11,000 to cover a Buy-In with respect to an attempted exercise of this Warrant with an aggregate sale price giving
rise to such purchase obligation of $10,000, under clause (A) of the immediately preceding sentence the Company shall be required
to pay the Holder $1,000. In connection with the foregoing, the Holder shall provide the Company written notice within three (3) Business
Days after the occurrence of a Buy-In, indicating the amounts payable to the Holder in respect of the Buy-In and, upon request of the
Company, evidence of the amount of such loss. Subject to Section 5(i), nothing herein shall limit a Holder’s right to pursue
any other remedies available to it hereunder, at law or in equity including, without limitation, a decree of specific performance and/or
injunctive relief with respect to the Company’s failure to timely deliver Warrant Shares upon exercise of the Warrant as required
pursuant to the terms hereof.
(iv). No Fractional Shares or Scrip. No
fractional shares or scrip representing fractional shares shall be issued upon the exercise of this Warrant. As to any fraction of a
share which the Holder would otherwise be entitled to purchase upon such exercise, the Company shall, at its election, either pay a cash
adjustment in respect of such final fraction in an amount equal to such fraction multiplied by the Exercise Price or round down to the
nearest whole share.
(v). Charges, Taxes and Expenses. Issuance
of certificates for Warrant Shares shall be made without charge to the Holder for any issue or transfer tax or other incidental expense
in respect of the issuance of such certificate, all of which taxes and expenses shall be paid by the Company, and such certificates shall
be issued in the name of the Holder or in such name or names as may be directed by the Holder; provided, however, that
in the event certificates for Warrant Shares are to be issued in a name other than the name of the Holder, this Warrant when surrendered
for exercise shall be accompanied by the Assignment Form attached hereto duly executed by the Holder and the Company may require,
as a condition thereto, the payment of a sum sufficient to reimburse it for any transfer tax incidental thereto.
(vi). Closing of Books. The Company will
not close its stockholder books or records in any manner which prevents the timely exercise of this Warrant pursuant to the terms hereof.
(d) Cashless Exercise. Notwithstanding
anything contained herein to the contrary, the Holder may exercise this Warrant, whether in whole or in part, and in lieu of making the
cash payment otherwise contemplated to be made to the Company upon such exercise in payment of the Exercise Price, by effecting a cashless
exercise of this Warrant pursuant to which the Holder shall receive upon such cashless exercise the “Net Number” of Warrant
Shares determined according to the following formula (a “Cashless Exercise”):
Net Number = (A
x B) - (A x C)
B
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For purposes of the foregoing formula:
A = the total number of shares of Common Stock with respect to which this
Warrant is then being exercised.
B = the Closing Sale Price of the shares of Common Stock on the date immediately
preceding the date of the Notice of Exercise.
C = the Exercise Price then in effect for the applicable Warrant Shares
at the time of such exercise.
In addition, if at the time of the proposed exercise
of this Warrant, there is not an effective registration statement for the sale of the Warrant Shares to the Holder for cash, then this
Warrant may only be exercised through a Cashless Exercise.
If Warrant Shares are issued in a Cashless Exercise,
the Company acknowledges and agrees that in accordance with Section 3(a)(9) of the 1933 Act, the Warrant Shares shall take
on the characteristics of the Warrant being exercised, and the holding period of the Warrant being exercised may be tacked on to the
holding period of the Warrant Shares. The Company agrees not to take any position contrary to this Section 2(d).
(e) Holder’s Exercise Limitations.
Notwithstanding anything to the contrary contained herein, the Company shall not effect the exercise of any portion of this Warrant,
and the Holder shall not have the right to exercise any portion of this Warrant, pursuant to the terms and conditions of this Warrant
and any such exercise shall be null and void and treated as if never made, to the extent that immediately prior to or after giving effect
to such exercise, the Holder together with the other Attribution Parties collectively would beneficially own in excess of 9.99% (the
“Maximum Percentage”) of the number of shares of Common Stock outstanding immediately after giving effect to such
exercise. For purposes of the foregoing sentence, the aggregate number of shares of Common Stock beneficially owned by the Holder and
the other Attribution Parties shall include the number of shares of Common Stock held by the Holder and all other Attribution Parties
plus the number of shares of Common Stock issuable upon exercise of this Warrant with respect to which the determination of such sentence
is being made, but shall exclude the number of shares of Common Stock which would be issuable upon (A) exercise of the remaining,
unexercised portion of this Warrant beneficially owned by the Holder or any of the other Attribution Parties and (B) exercise or
conversion of the unexercised or unconverted portion of any other securities of the Company (including, without limitation, any convertible
notes or convertible preferred stock or warrants, including the other Warrants) beneficially owned by the Holder or any other Attribution
Party subject to a limitation on conversion or exercise analogous to the limitation contained in this Section 2(e). For purposes
of this Section 2(e), beneficial ownership shall be calculated in accordance with Section 13(d) of the 1934 Act and the
rules and regulations promulgated thereunder, it being acknowledged by the Holder that the Company is not representing to the Holder
that such calculation is in compliance with Section 13(d) of the 1934 Act and the Holder is solely responsible for any schedules
required to be filed in accordance therewith. In addition, a determination as to any group status as contemplated above shall be determined
in accordance with Section 13(d) of the 1934 Act and the rules and regulations promulgated thereunder. For purposes of
this Warrant, in determining the number of outstanding shares of Common Stock the Holder may acquire upon the exercise of this Warrant
without exceeding the Maximum Percentage, the Holder may rely on the number of outstanding shares of Common Stock as reflected in (x) the
Company’s most recent Annual Report on Form 10-K, Quarterly Report on Form 10-Q and Current Reports on Form 8-K
or other public filing with the Securities and Exchange Commission (the “SEC”), as the case may be, (y) a more
recent public announcement by the Company or (z) any other written notice by the Company setting forth the number of shares of Common
Stock outstanding (the “Reported Outstanding Share Number”). If the Company receives a Notice of Exercise from the
Holder at a time when the actual number of outstanding shares of Common Stock is less than the Reported Outstanding Share Number, the
Company shall (i) notify the Holder in writing of the number of shares of Common Stock then outstanding and, to the extent that
such Exercise Notice would otherwise cause the Holder’s beneficial ownership, as determined pursuant to this Section 2(e),
to exceed the Maximum Percentage, the Holder must notify the Company of a reduced number of Warrant Shares to be purchased pursuant to
such Exercise Notice (the number of shares by which such purchase is reduced, the “Reduction Shares”) and (ii) as
soon as reasonably practicable, the Company shall return to the Holder any exercise price paid by the Holder for the Reduction Shares.
Upon the written request of the Holder, the Company shall within one (1) Business Day confirm in writing (including by electronic
mail) to the Holder that the number of shares of Common Stock then outstanding is not less than the Company’s most recently reported
outstanding share number or, if the number of shares of Common Stock then outstanding is less than the Company’s most recently
reported outstanding share number, the Company shall confirm in writing (including by electronic mail) to the Holder the number of shares
of Common Stock outstanding. In any case, the number of outstanding shares of Common Stock shall be determined after giving effect to
the conversion or exercise of securities of the Company, including this Warrant, by the Holder and any other Attribution Party since
the date as of which the Reported Outstanding Share Number was reported. In the event that the issuance of Common Stock to the Holder
upon exercise of this Warrant results in the Holder and the other Attribution Parties being deemed to beneficially own, in the aggregate,
more than the Maximum Percentage of the number of outstanding shares of Common Stock (as determined under Section 13(d) of
the 1934 Act), the number of shares so issued by which the Holder’s and the other Attribution Parties’ aggregate beneficial
ownership exceeds the Maximum Percentage (the “Excess Shares”) shall be deemed null and void and shall be cancelled
ab initio, and the Holder shall not have the power to vote or to transfer the Excess Shares. As soon as reasonably practicable after
the issuance of the Excess Shares has been deemed null and void, the Company shall return to the Holder the exercise price paid by the
Holder for the Excess Shares. Upon delivery of a written notice to the Company, the Holder may from time to time increase or decrease
the Maximum Percentage to any other percentage (not in excess of 19.99% of the issued and outstanding shares of Common Stock immediately
after giving effect to the issuance of the shares of Common Stock issuable upon exercise of this Warrant if exceeding that limit would
result in a change of control under Nasdaq Listing Rule 5635(b) or any successor rule) as specified in such notice; provided
that (i) any such increase in the Maximum Percentage will not be effective until the sixty-first (61st) day after such notice is
delivered to the Company and (ii) any such increase or decrease will apply only to the Holder and the other Attribution Parties
and not to any other holder of Warrants that is not an Attribution Party of the Holder. For purposes of clarity, the shares of Common
Stock issuable pursuant to the terms of this Warrant in excess of the Maximum Percentage shall not be deemed to be beneficially owned
by the Holder for any purpose including for purposes of Section 13(d) or Rule 16a-1(a)(1) of the 1934 Act. No prior
inability to exercise this Warrant pursuant to this paragraph shall have any effect on the applicability of the provisions of this paragraph
with respect to any subsequent determination of exercisability. The provisions of this paragraph shall be construed and implemented in
a manner otherwise than in strict conformity with the terms of this Section 2(e) to the extent necessary to correct this paragraph
or any portion of this paragraph which may be defective or inconsistent with the intended beneficial ownership limitation contained in
this Section 2(e) or to make changes or supplements necessary or desirable to properly give effect to such limitation. The
19.99% limitation contained in this paragraph may not be waived and both the nonwaivable 19.99% limitation and the Maximum Percentage
shall apply to a successor holder of this Warrant.
4
Section 3. Certain Adjustments.
(a) Subdivision or Combination of Common
Stock. If at any time while this Warrant is outstanding the Company subdivides (by any stock
split, stock dividend, recapitalization or otherwise) one or more classes of its outstanding shares of Common Stock into a greater number
of shares, the Exercise Price in effect immediately prior to such subdivision will be proportionately reduced and the number of Warrant
Shares will be proportionately increased. If at any time while this Warrant is outstanding the
Company combines (by combination, reverse stock split or otherwise) one or more classes of its outstanding shares of Common Stock into
a smaller number of shares, the Exercise Price in effect immediately prior to such combination will be proportionately increased and
the number of Warrant Shares will be proportionately decreased. Any adjustment under this Section 3(a) shall become effective
at the close of business on the date the subdivision or combination becomes effective.
(b) Subsequent Rights Offerings.
In addition to any adjustments pursuant to Section 3(a) above, if during such time as this Warrant is outstanding the Company
grants, issues or sells any rights to purchase stock, warrants, securities or other property, in each case pro rata to the record holders
of any class of shares of Common Stock (the “Purchase Rights”), then the Holder will be entitled to acquire, upon
the terms applicable to such Purchase Rights, the aggregate Purchase Rights which the Holder could have acquired if the Holder had held
the number of shares of Common Stock acquirable upon complete exercise of this Warrant (without regard to any limitations on exercise
hereof, including without limitation, Section 2(e) hereof) immediately before the date on which a record is taken for the grant,
issuance or sale of such Purchase Rights, or, if no such record is taken, the date as of which the record holders of shares of Common
Stock are to be determined for the grant, issue or sale of such Purchase Rights (provided, however, to the extent that
the Holder’s right to participate in any such Purchase Right would result in the Holder and
the other Attribution Parties exceeding the Maximum Percentage, then the Holder shall
not be entitled to participate in such Purchase Right to such extent (or beneficial ownership of such shares of Common Stock as a result
of such Purchase Right to such extent) and such Purchase Right to such extent shall be held in abeyance for the Holder until such time,
if ever, as its right thereto would not result in the Holder and the other Attribution Parties
exceeding the Maximum Percentage).
5
(c) Pro Rata Distributions. If at
any time while this Warrant is outstanding the Company shall declare or make any dividend or other distribution of its assets (or rights
to acquire its assets) to all holders of shares of Common Stock, by way of return of capital or otherwise (including, without limitation,
any distribution of cash, stock or other securities, property or options by way of a dividend, spin off, reclassification, corporate
rearrangement, scheme of arrangement or other similar transaction) (a “Distribution”), then, in each such case, the
Holder shall be entitled to participate in such Distribution to the same extent that the Holder would have participated therein if the
Holder had held the number of shares of Common Stock acquirable upon complete exercise of this Warrant (without regard to any limitations
on exercise hereof, including without limitation, Section 2(e) hereof) immediately before the date of which a record is taken
for such Distribution, or, if no such record is taken, the date as of which the record holders of shares of Common Stock are to be determined
for the participation in such Distribution (provided, however, to the extent that the Holder’s right to participate
in any such Distribution would result in the Holder and the other Attribution Parties exceeding
the Maximum Percentage, then the Holder shall not be entitled to participate in such Distribution
to such extent (or in the beneficial ownership of any shares of Common Stock as a result of such Distribution to such extent) and the
applicable portion of such Distribution shall be held in abeyance for the benefit of the Holder until such time, if ever, as its right
thereto would not result in the Holder and the other Attribution Parties exceeding the Maximum
Percentage).
(d) Fundamental Transaction. Unless
earlier exercised, this Warrant shall automatically be deemed fully exercised in accordance with the provisions of Section 2(d) hereof
immediately prior to the consummation of a Fundamental Transaction, without regard to any limitations on exercise contained herein, and
after the completion of such full exercise, shall be deemed terminated upon the consummation of such Fundamental Transaction. “Fundamental
Transaction” means that (A) the Company shall, directly or indirectly, in one or more related transactions, (i) consolidate
or merge with or into another Person in a transaction in which the Company is not the surviving entity or the stockholders of the Company
immediately prior to such merger or consolidation do not own, directly or indirectly, more than 50% of the voting power of the surviving
entity immediately after such merger or consolidation, (ii) sell, assign, transfer, convey or otherwise dispose of all or a majority
of the properties or assets of the Company on a consolidated basis to another Person, (iii) allow another Person to make a purchase,
tender or exchange offer that results in such Person acquiring more than 50% of the outstanding shares of Common Stock (not including
any shares of Common Stock held by the Person or Persons making or party to, or associated or affiliated with the Persons making or party
to, such purchase, tender or exchange offer), or (iv) consummate a stock purchase agreement or other business combination (including,
without limitation, a reorganization, recapitalization, spin-off or similar transaction) with another Person whereby (A) such other
Person acquires more than 50% of the outstanding shares of Common Stock (not including any shares of Common Stock held by the other Person
or other Persons making or party to, or associated or affiliated with the other Persons making or party to, such stock purchase agreement
or other business combination) or (B) any Person or Group is or shall become the beneficial owner (determined in accordance with
Section 13(d) of the 1934 Act and the rules and regulations promulgated thereunder), directly or indirectly, of more than
50% of the aggregate ordinary voting power represented by issued and outstanding Common Stock.
(e) Calculations. All calculations
under this Section 3 shall be made to the nearest cent or the nearest whole share, as the case may be. For purposes of this Section 3,
any calculation of the number of shares of Common Stock deemed to be issued and outstanding as of a given date shall not include treasury
shares, if any. In any case in which this Section 3 shall require that an adjustment in the Exercise Price be made effective as
of a record date for a specified event, if Holder exercises this Warrant after such record date, the Company may elect to defer, until
the occurrence of such event, the issuance of the shares of Common Stock and other capital stock of the Company in excess of the shares
of Common Stock and other capital stock of the Company, if any, issuable upon such exercise on the basis of the Exercise Price in effect
prior to such adjustment; provided, however, that in such case the Company shall deliver to the Holder a due bill or other
appropriate instrument evidencing the Holder’s right to receive such additional shares and/or other capital securities upon the
occurrence of the event requiring such adjustment.
(f) Par Value. Notwithstanding anything
to the contrary in this Warrant, in no event shall the Exercise Price be reduced below the par value of the Company’s Common Stock.
6
Section 4. Transfer of Warrant.
(a) Transferability. Subject to compliance
with any applicable securities laws, this Warrant and all rights hereunder are transferable, in whole or in part, upon surrender of this
Warrant at the principal office of the Company (or other designated agent), together with a written assignment of this Warrant substantially
in the form attached hereto duly executed by the Holder or its agent or attorney and funds sufficient to pay any transfer taxes payable
upon the making of such transfer. Upon such surrender and, if required, such payment, the Company shall execute and deliver a new Warrant
or Warrants in the name of the assignee or assignees, as applicable, and in the denomination or denominations specified in such instrument
of assignment, and shall issue to the assignor a new Warrant evidencing the portion of this Warrant not so assigned, and this Warrant
shall promptly be cancelled. The Warrant, if properly assigned in accordance herewith, may be exercised by a new holder for the purchase
of Warrant Shares without having a new Warrant issued.
(b) New Warrants. This Warrant may
be divided or combined with other Warrants upon presentation hereof at the aforesaid office of the Company (or other designated agent),
together with a written notice specifying the names and denominations in which new Warrants are to be issued, signed by the Holder or
its agent or attorney. Subject to compliance with Section 4(a), as to any transfer which may be involved in such division or combination,
the Company shall execute and deliver a new Warrant or Warrants in exchange for the Warrant or Warrants to be divided or combined in
accordance with such notice. All Warrants issued on transfers or exchanges shall be dated the Issue Date set forth on the first page of
this Warrant and shall be identical to this Warrant except as to the number of Warrant Shares issuable pursuant thereto.
(c) Warrant Register. The Company
shall initially serve as warrant agent under this Warrant. The Company shall register ownership of this Warrant, upon records to be maintained
by the Company for that purpose (the “Warrant Register”), in the name of the record Holder (which shall include the
initial Holder or, as the case may be, any assignee to which this Warrant is assigned hereunder) from time to time. Upon thirty (30)
days’ notice to the Holder, the Company may appoint a new warrant agent. Any corporation into which the Company or any new warrant
agent may be merged or any corporation resulting from any consolidation to which the Company or any new warrant agent shall be a party
or any corporation to which the Company or any new warrant agent transfers substantially all of its corporate trust or shareholders services
business shall be a successor warrant agent under this Warrant without any further act. Any such successor warrant agent shall promptly
cause notice of its succession as warrant agent to be mailed (by first class mail, postage prepaid) to the Holder at the Holder’s
last address as shown on the Warrant Register. The Company may deem and treat the registered Holder of this Warrant as the absolute owner
hereof for the purpose of any exercise hereof or any distribution to the Holder, and for all other purposes, absent actual notice to
the contrary.
Section 5. Miscellaneous.
(a) No Rights as Stockholder Until Exercise.
This Warrant does not entitle the Holder to any voting rights, dividends or other rights as a stockholder of the Company prior to the
exercise hereof as set forth in Section 2.
(b) Loss, Theft, Destruction or Mutilation
of Warrant. The Company covenants that upon receipt by the Company of evidence reasonably satisfactory to them of the loss, theft,
destruction or mutilation of this Warrant, and in case of loss, theft or destruction, of indemnity or security reasonably satisfactory
to it, and upon surrender and cancellation of such Warrant, if mutilated, the Company will make and deliver a new Warrant of like tenor
and dated as of such cancellation, in lieu of such Warrant or stock certificate.
(c) Saturdays, Sundays, Holidays, etc.
If the last or appointed day for the taking of any action or the expiration of any right required or granted herein shall not be a Business
Day, then such action may be taken or such right may be exercised on the next succeeding Business Day.
(d) Authorized Shares. The Company
covenants that, during the period the Warrant is outstanding, it will reserve from its authorized and unissued Common Stock a sufficient
number of shares to provide for the issuance of the Warrant Shares upon the exercise of any purchase rights under this Warrant (without
regard to any limitations on exercise contained herein). The Company further covenants that its issuance of this Warrant shall constitute
full authority to its officers who are charged with the duty of executing stock certificates to execute and issue the necessary certificates
for the Warrant Shares upon the exercise of the purchase rights under this Warrant. The Company will take all such reasonable action
as may be necessary to assure that such Warrant Shares may be issued as provided herein without violation of any applicable law or regulation,
or of any requirements of the Trading Market. The Company covenants that all Warrant Shares which may be issued upon the exercise of
the purchase rights represented by this Warrant will, upon exercise of the purchase rights represented by this Warrant and payment for
such Warrant Shares in accordance herewith, be duly authorized, validly issued, fully paid and nonassessable and free from all taxes,
liens and charges created by the Company in respect of the issuance thereof (other than taxes in respect of any transfer occurring contemporaneously
with such issuance). Except and to the extent as waived or consented to by the Holder, the Company shall not by any action, including,
without limitation, amending its certificate of incorporation or through any reorganization, transfer of assets, consolidation, merger,
dissolution, issuance or sale of securities or any other voluntary action, in each case to avoid or seek to avoid the observance or performance
of any of the terms of this Warrant, but will at all times in good faith assist in the carrying out of all such terms and in the taking
of all such actions as may be necessary or appropriate to protect the rights of Holder as set forth in this Warrant against impairment.
Without limiting the generality of the foregoing, the Company will (i) not increase the par value of any Warrant Shares above the
amount payable therefor upon such exercise immediately prior to such increase in par value, (ii) take all such action as may be
necessary or appropriate in order that the Company may validly and legally issue fully paid and nonassessable Warrant Shares upon the
exercise of this Warrant and (iii) use commercially reasonable efforts to obtain all such authorizations, exemptions or consents
from any public regulatory body having jurisdiction thereof, as may be, necessary to enable the Company to perform its obligations under
this Warrant.
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(e) Governing Law. This Warrant shall
be governed by, and construed in accordance with, the laws of the State of New York without giving effect to the conflicts of law principles
thereof.
(f) Nonwaiver and Expenses. No course
of dealing or any delay or failure to exercise any right hereunder on the part of the Holder shall operate as a waiver of such right
or otherwise prejudice the Holder’s rights, powers or remedies. Without limiting any other provision of this Warrant, if the Company
willfully and knowingly fails to comply with any provision of this Warrant, which results in any material damages to the Holder, the
Company shall pay to the Holder such amounts as shall be sufficient to cover any costs and expenses including, but not limited to, reasonable
attorneys’ fees, including those of appellate proceedings, incurred by the Holder in collecting any amounts due pursuant hereto
or in otherwise enforcing any of its rights, powers or remedies hereunder.
(g) Notices.
(i). Notice Procedures. Any and all notices
or other communications or deliveries required or permitted to be provided hereunder shall be in writing and shall be deemed given and
effective on the earliest of: (a) the date of transmission, if such notice or communication is delivered via email at or prior to
5:30 p.m. (New York City time) on a Trading Day, (b) the next Trading Day after the date of transmission, if such notice or
communication is delivered via email on a day that is not a Trading Day or later than 5:30 p.m. (New York City time) on any Trading
Day, (c) the second (2nd) Trading Day following the date of mailing, if sent by U.S. nationally recognized overnight courier service
or by International Federal Express, (d) the third (3rd) Trading Day following the
date of mailing if sent by first-class registered or certified mail domestic, or (e) upon
actual receipt by the party to whom such notice is required to be given. The addresses for such communications shall be:
If to the Company:
Aclaris Therapeutics, Inc.
701 Lee Road, Suite 103
Wayne, PA 19087
Attention: Legal Department
With copy to:
Cooley LLP
11951 Freedom Drive
Reston, Virginia 20190-5640
Attention: Mark Ballantyne
8
If to the Holder:
To the address or email address set
forth in the Warrant Register, or as otherwise provided by the Holder to the Company in accordance with this Section 5(g)(i).
(ii). Adjustment to Exercise Price. Whenever
the Exercise Price or number of Warrant Shares is adjusted pursuant to any provision of Section 3, the Company shall, at the written
request of the Holder, promptly provide the Holder a notice setting forth the Exercise Price and number of Warrant Shares after such
adjustment and setting forth a brief statement of the facts requiring such adjustment.
(iii). Notice to Allow Exercise by the Holder.
After the Issue Date if (A) the Company shall declare a dividend (or any other distribution in whatever form) on the Common Stock,
(B) the Company shall declare a special nonrecurring cash dividend on or a redemption of the Common Stock, (C) the Company
shall authorize the granting to all holders of the Common Stock rights or warrants to subscribe for or purchase any shares of capital
stock of any class or of any rights, (D) the approval of any stockholders of the Company shall be required in connection with any
reclassification of the Common Stock, any consolidation or merger to which the Company is a party, any sale or transfer of all or substantially
all of the assets of the Company (which, for the avoidance of doubt, shall not include a license or other agreement granting rights to
intellectual property), or any compulsory share exchange whereby the Common Stock is converted into other securities, cash or property,
or (E) the Company shall authorize the voluntary or involuntary dissolution, liquidation or winding up of the affairs of the Company,
then, in each case, the Company shall cause to be mailed to the Holder at its last address as it shall appear upon the Warrant Register,
at least ten (10) calendar days prior to the applicable record or effective date hereinafter specified, a notice stating (x) the
date on which a record is to be taken for the purpose of such dividend, distribution, redemption, rights or warrants, or vote of stockholders,
or if a record is not to be taken, the date as of which the holders of the Common Stock of record to be entitled to such dividend, distributions,
redemption, rights or warrants are to be determined or (y) the date on which such reclassification, consolidation, merger, sale,
transfer, share exchange, dissolution, liquidation or winding up is expected to become effective or close, and the date as of which it
is expected that holders of the Common Stock of record shall be entitled to exchange their shares of the Common Stock for securities,
cash or other property deliverable upon such reclassification, consolidation, merger, sale, transfer, share exchange, dissolution, liquidation
or winding up; provided that the failure to mail such notice or any defect therein or in the mailing thereof shall not affect
the validity of the corporate action required to be specified in such notice. To the extent that any notice provided hereunder constitutes,
or contains, material, non-public information regarding the Company or any of its subsidiaries, the Company shall promptly file such
notice with the SEC pursuant to a Current Report on Form 8-K.
(h) Limitation of Liability. No provision
hereof, in the absence of any affirmative action by the Holder to exercise this Warrant to purchase Warrant Shares, and no enumeration
herein of the rights or privileges of the Holder, shall give rise to any liability of the Holder for the purchase price of any Common
Stock or as a stockholder of the Company, whether such liability is asserted by the Company or by creditors of the Company.
(i) Remedies. The Holder, in addition
to being entitled to exercise all rights granted by law, including recovery of damages, will be entitled to specific performance of its
rights under this Warrant. The Company agrees that monetary damages would not be adequate compensation for any loss incurred by reason
of a breach by it of the provisions of this Warrant and hereby agrees to waive and not to assert the defense in any action for specific
performance that a remedy at law would be adequate. Notwithstanding the foregoing or anything else herein to the contrary, if the Company
is for any reason unable to issue and deliver Warrant Shares upon exercise of this Warrant as required pursuant to the terms hereof,
the Company shall have no obligation to pay to the Holder any cash or other consideration or otherwise “net cash settle”
this Warrant.
(j) Successors and Assigns. Subject
to applicable securities laws, this Warrant and the rights and obligations evidenced hereby shall inure to the benefit of and be binding
upon the successors and permitted assigns of the Company and the successors and permitted assigns of the Holder. The provisions of this
Warrant are intended to be for the benefit of any Holder from time to time of this Warrant and shall be enforceable by the Holder or
holder of Warrant Shares.
(k) Amendment. This Warrant may be
modified or amended or the provisions hereof waived with the written consent of the Company and the Holder.
(l) Severability. Wherever possible,
each provision of this Warrant shall be interpreted in such manner as to be effective and valid under applicable law, but if any provision
of this Warrant shall be prohibited by or invalid under applicable law, such provision shall be ineffective to the extent of such prohibition
or invalidity, without invalidating the remainder of such provisions or the remaining provisions of this Warrant.
9
(m) Confidentiality. The Holder agrees
to keep confidential any proprietary information relating to the Company delivered by the Company hereunder; provided that nothing herein
shall prevent the Holder from disclosing such information: (i) to any holder of Warrants or Warrant Shares, (ii) to any Affiliate
of any holder of Warrants or Warrant Shares or any actual or potential transferee of the rights or obligations hereunder that agrees
to be bound by this Section 5(m), (iii) upon order, subpoena, or other process of any court or administrative agency or otherwise
required by law, (iv) upon the request or demand of any regulatory agency or authority having jurisdiction over such party, (v) which
has been publicly disclosed without breach of any obligation to the Company, (vi) which has been obtained from any Person that is
not a party hereto or an Affiliate of any such party without any breach of any obligation to the Company, (vii) in connection with
the exercise of any remedy, or the resolution of any dispute hereunder, (viii) to the legal counsel or certified public accountants
for any holder of Warrants or Warrant Shares, or (ix) as otherwise expressly contemplated by this Warrant. Notwithstanding the foregoing,
the Company shall not provide material, non-public information or confidential or proprietary information to the Holder without such
Holder’s written consent. If the Company does provide material, non-public information or confidential or proprietary information
to the Holder without such Holder’s written consent, the Company shall promptly file such information with the SEC pursuant to
a Current Report on Form 8-K and the Holder shall not be subject to any duty of confidentiality contained herein with respect to
such information.
(n) Dispute Resolution. In the case
of a dispute as to the determination of the Exercise Price or the arithmetic calculation of the Warrant Shares, the Company shall submit
the disputed determinations or arithmetic calculations via email within two (2) Business Days of receipt of the Notice of Exercise
giving rise to such dispute, as the case may be, to the Holder. If the Holder and the Company are unable to agree upon such determination
or calculation of the Exercise Price or the Warrant Shares within three (3) Business Days of such disputed determination or arithmetic
calculation being submitted to the Holder, then the Company shall, within two (2) Business Days submit via email (i) the disputed
determination of the Exercise Price to an independent, reputable investment bank selected by the Company and approved by the Holder or
(ii) the disputed arithmetic calculation of the Warrant Shares to the Company’s independent, outside accountant. The Company
shall cause at its expense the investment bank or the accountant, as the case may be, to perform the determinations or calculations and
notify the Company and the Holder of the results no later than ten (10) Business Days from the time it receives the disputed determinations
or calculations. Such investment bank’s or accountant’s determination or calculation, as the case may be, shall be binding
upon all parties absent demonstrable error. The expenses of the investment bank and accountant will be borne by the Company unless the
investment bank or accountant determines that the determination of the Exercise Price or the arithmetic calculation of the Warrant Shares
by the Holder was incorrect, in which case the expenses of the investment bank and accountant will be borne by the Holder.
(o) Headings. The headings used in
this Warrant are for the convenience of reference only and shall not, for any purpose, be deemed a part of this Warrant.
********************
(Signature Pages Follow)
10
IN WITNESS WHEREOF, the Company has caused this
Pre-Funded Common Stock Purchase Warrant to be executed by its officer thereunto duly authorized as of the date first above indicated.
ACLARIS
THERAPEUTICS, INC.
By:
Name:
Title:
11
NOTICE OF EXERCISE
TO: ACLARIS THERAPEUTICS, INC.
(1) The undersigned holder of Warrant No. PF-
hereby elects to purchase Warrant
Shares of the Company pursuant to the terms of the attached Warrant (only if exercised in full), and tenders herewith payment of the
exercise price in full, together with all applicable transfer taxes, if any.
(2) Payment shall take the form of (check
applicable box):
¨
Cash Exercise: lawful money of the United States; or
¨
Cashless Exercise: the cancellation of such number of Warrant Shares as is necessary,
in accordance with the formula set forth in Section 2(d), to exercise this Warrant with respect to the maximum number of Warrant
Shares purchasable pursuant to the cashless exercise procedure set forth in Section 2(d).
(3) Please issue said Warrant Shares in
the name of the undersigned or in such other name as is specified below:
(4) By its delivery of this Notice of Exercise,
the undersigned represents and warrants to the Company that in giving effect to the exercise evidenced hereby the Holder will not beneficially
own in excess of the number of shares of Common Stock (as determined in accordance with Section 13(d) of the Securities Exchange
Act of 1934, as amended) permitted to be owned under Section 2(e) of the Warrant to which this notice relates.
The Warrant Shares shall be delivered to the
following DWAC Account Number or in book-entry form via a direct registration system to:
[SIGNATURE OF HOLDER]
Name
of Investing Entity:
Signature
of Authorized Signatory of Investing Entity:
Name
of Authorized Signatory:
Title
of Authorized Signatory:
Date:
12
ASSIGNMENT FORM
(To assign the foregoing warrant, execute
this form and supply required information.
Do not use this form to exercise the warrant.)
FOR VALUE RECEIVED, [ ]
all of or [ ] shares of the foregoing Warrant and all rights evidenced
thereby are hereby assigned to
whose
address is
.
Dated:
Holder’s
Signature:
Holder’s
Address:
NOTE: The signature to this Assignment Form must
correspond with the name as it appears on the face of the Warrant, without alteration or enlargement or any change whatsoever.
13
EX-5.1 — EXHIBIT 5.1
EX-5.1
Filename: tm2628355d1_ex5-1.htm · Sequence: 4
Exhibit 5.1
Mark D. Ballantyne
T: +1 703 456 8084
mballantyne@cooley.com
October 27, 2026
Aclaris Therapeutics, Inc.
701 Lee Road, Suite 103
Wayne, Pennsylvania 19087
Ladies and Gentlemen:
We have acted as counsel to Aclaris Therapeutics, Inc.,
a Delaware corporation (the “Company”), in connection with the offering by the Company of (i) up to 7,785,714
shares (the “Shares”) of the Company’s common stock, par value $0.00001 per share (“Common
Stock”), and (ii) pre-funded warrants (the “Warrants”) to purchase up to 6,500,000 shares
of Common Stock (the “Warrant Shares”), pursuant to a Registration Statement on Form S-3 (File No. 333-298084)
(the “Registration Statement”) filed by the Company with the Securities and Exchange Commission (the “Commission”)
under the Securities Act of 1933, as amended (the “Securities Act”), the base prospectus included in the Registration
Statement (the “Base Prospectus”) and the prospectus supplement with respect to the Shares, the Warrants and
the Warrant Shares dated October 27, 2026, filed with the Commission pursuant to Rule 424 under the Securities Act (together
with the Base Prospectus, the “Prospectus”).
In connection with this opinion, we have examined
and relied upon (a) the Registration Statement and the Prospectus, (b) the form of the Warrants to be filed as an exhibit to
a Current Report on Form 8-K, (c) the Company’s certificate of incorporation and bylaws, each as currently in effect,
and such other records, documents, opinions, certificates, memoranda and instruments as in our judgment are necessary or appropriate
to enable us to render the opinion expressed below. We have assumed the genuineness of all signatures, the authenticity of all documents
submitted to us as originals, the conformity to originals of all documents submitted to us as copies, the accuracy, completeness and
authenticity of certificates of public officials, and the due authorization, execution and delivery of all documents by all persons other
than the Company. As to certain factual matters, we have relied upon a certificate of an officer of the Company and have not independently
verified such matters.
With regard to our opinion below with respect
to the Warrants and the Warrant Shares, we have assumed (i) that a sufficient number of shares of Common Stock will be available
for issuance under the Company’s certificate of incorporation at the time the Warrant Shares are issued and (ii) that the
consideration received by the Company upon exercise of the Warrants will be at least equal to the par value of the Warrant Shares.
Our opinion is expressed solely with respect
to the General Corporation Law of the State of Delaware and, as to the Warrants constituting binding obligations of the Company, the
laws of the State of New York. We express no opinion to the extent that any other laws are applicable to the subject matter hereof and
express no opinion and provide no assurance as to compliance with any federal or state securities law, rule or regulation.
Cooley LLP Reston Town Center
11951 Freedom Drive 14th Floor Reston, VA 20190-5656
t: +1 703 456 8000 f: +1 703 456 8100 cooley.com
Aclaris Therapeutics, Inc.
October 27, 2026
Page Two
With regard
to our opinion concerning the Warrants constituting binding obligations of the Company:
(i) Our
opinion is subject to, and may be limited by, (a) applicable bankruptcy, reorganization, insolvency, moratorium, fraudulent conveyance,
debtor and creditor, and similar laws which relate to or affect creditors’ rights generally, and (b) general principles of
equity (including, without limitation, concepts of materiality, reasonableness, good faith and fair dealing) regardless of whether considered
in a proceeding in equity or at law;
(ii) Our
opinion is subject to the qualification that (a) the enforceability of provisions for indemnification or limitations on liability
may be limited by applicable law and by public policy considerations, and (b) the availability of specific performance, an injunction
or other equitable remedies is subject to the discretion of the court before which the request is brought;
(iii) We
express no opinion with respect to any provision of the Warrants that: (a) relates to the subject matter jurisdiction of any federal
court of the United States of America or any federal appellate court to adjudicate any controversy related to the Warrants; (b) specifies
provisions may be waived in writing, to the extent that an oral agreement or implied agreement by trade practice or course of conduct
has been created that modifies such provision; (c) contains a waiver of an inconvenient forum; (d) provides for liquidated
damages, default interest, late charges, monetary penalties, prepayment or make-whole payments or other economic remedies; (e) relates
to advance waivers of claims, defenses, rights granted by law, or notice, opportunity for hearing, evidentiary requirements, statutes
of limitations, trial by jury, service of process or procedural rights; (f) restricts non-written modifications and waivers; (g) provides
for the payment of legal and other professional fees where such payment is contrary to law or public policy; (h) relates to exclusivity,
election or accumulation of rights or remedies; or (i) provides that provisions of the Warrants are severable to the extent an essential
part of the agreed exchange is determined to be invalid and unenforceable; and
(iv) We
express no opinion as to whether a state court outside of the State of New York or a federal court of the United States would give effect
to the choice of New York law or jurisdiction provided for in the Warrants.
On the basis of the foregoing, in reliance thereon
and subject to the assumptions, qualifications, limitations and exceptions set forth herein, we are of the opinion that (i) the
Shares, when sold and issued against payment therefor in accordance with the Registration Statement and the Prospectus, will be validly
issued, fully paid and nonassessable, (ii) the Warrants, when duly executed and delivered by the Company against payment therefor
as described in the Registration Statement and the Prospectus, will be binding obligations of the Company and (iii) the Warrant
Shares, when issued and paid for in accordance with the terms of the Warrants, will be validly issued, fully paid and nonassessable.
This opinion is limited to the matters expressly
set forth in this letter, and no opinion has been or should be implied, or may be inferred, beyond the matters expressly stated. This
opinion speaks only as to law and facts in effect or existing as of the date hereof, and we have no obligation or responsibility to update
or supplement this letter to reflect any facts or circumstances that may hereafter come to our attention or any changes in law that may
hereafter occur.
Cooley LLP Reston Town Center
11951 Freedom Drive 14th Floor Reston, VA 20190-5656
t: +1 703 456 8000 f: +1 703 456 8100 cooley.com
Aclaris Therapeutics, Inc.
October 27, 2026
Page Three
We consent to the reference to our firm under
the heading “Legal Matters” in the Prospectus and to the filing of this opinion as an exhibit to the Company’s Current
Report on Form 8-K to be filed with the Commission for incorporation by reference into the Registration Statement. In giving such
consents, we do not thereby admit that we are in the category of persons whose consent is required under Section 7 of the Securities
Act or the rules and regulations of the Commission thereunder.
Very truly yours,
Cooley LLP
By:
/s/ Mark D. Ballantyne
Mark D. Ballantyne
Cooley LLP Reston Town Center
11951 Freedom Drive 14th Floor Reston, VA 20190-5656
t: +1 703 456 8000 f: +1 703 456 8100 cooley.com
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