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Form 8-K

sec.gov

8-K — Longeveron Inc.

Accession: 0001213900-26-055806

Filed: 2026-05-13

Period: 2026-05-13

CIK: 0001721484

SIC: 2834 (PHARMACEUTICAL PREPARATIONS)

Item: Results of Operations and Financial Condition

Item: Financial Statements and Exhibits

Documents

8-K — ea0290436-8k_longeveron.htm (Primary)

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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):

May 13, 2026

Longeveron Inc.

(Exact name of registrant as specified in its

charter)

Delaware

001-40060

47-2174146

(State or Other Jurisdiction

of Incorporation)

(Commission File Number)

(IRS Employer

Identification No.)

1951 NW 7th Avenue, Suite 520

Miami, Florida

33136

(Address of Principal Executive Offices)

(Zip Code)

Registrant’s Telephone Number, Including

Area Code: (305) 909-0840

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

Class A Common Stock, $0.001 par value per share

LGVN

The Nasdaq Capital Market

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 2.02. Results of Operations and Financial Condition

On May 13, 2026, Longeveron Inc. (the “Company”)

issued a press release announcing its financial and operating results for the three months ended March 31, 2026 and certain other business

updates and information. The full text of the press release is attached as Exhibit 99.1 to this Current Report on Form 8-K and incorporated

by reference herein.

The information provided under this Form 8-K (including

Exhibit 99.1) shall not be deemed “filed” for any purposes of Section 18 of the Securities Exchange Act of 1934 (the “Exchange

Act”) or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under

the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such a filing.

Item 9.01. Financial Statements and Exhibits.

(d) Exhibits.

The exhibits listed in the following Exhibit Index

are being furnished as part of this Current Report on Form 8-K.

Exhibit No.

Description

99.1

Press Release issued by the Company on May 13, 2026

104

Cover Page Interactive Data File (embedded within the Inline XBRL document)

1

SIGNATURE

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.

LONGEVERON INC.

Date: May 13, 2026

/s/ Lisa A. Locklear

Name:

Lisa A. Locklear

Title:

Chief Financial Officer

2

EX-99.1 — PRESS RELEASE ISSUED BY THE COMPANY ON MAY 13, 2026

EX-99.1

Filename: ea029043601ex99-1.htm · Sequence: 2

Exhibit 99.1

Longeveron Announces 2026 First Quarter Financial

Results and Provides Business Update

● On track for August 2026 top-line results from Phase 2b clinical trial

(ELPIS II) evaluating laromestrocel as a potential adjunct treatment for hypoplastic left heart syndrome, a rare pediatric disease and

orphan-designated indication

● Closed a private placement of up to $30 million, with $15 million funded

in the initial closing, led by Coastlands Capital with participation from Janus Henderson Investors and other healthcare focused funds

● Company to host conference call and webcast today at 4:30 p.m. ET

MIAMI, Fla., May 13, 2026 -- Longeveron Inc. (NASDAQ:

LGVN), a clinical stage biotechnology company developing cellular therapy for life-threatening, rare pediatric and chronic aging-related

conditions, today reported financial results for the quarter ended March 31, 2026 and provided a business update.

“Earlier this year, we initiated a strategic

repositioning of Longeveron designed to maximize shareholder value while maintaining disciplined capital allocation,” said Stephen

H. Willard, Chief Executive Officer of Longeveron. “We have transitioned toward a more capital-efficient, asset-light operating

model, with an increased focus on securing strategic licensing partnerships for our stem cell therapy laromestrocel in four development

programs. Longeveron is approaching a series of potentially transformative milestones across these programs that have the potential to

redefine the trajectory of our business, with the first catalyst, top line results from our Phase 2b clinical trial in HLHS, anticipated

in August of this year.”

Development Programs

Longeveron’s investigational therapeutic

candidate laromestrocel (Lomecel-B®) is a proprietary, scalable, allogeneic cellular therapy being evaluated in multiple

indications.

Hypoplastic Left Heart Syndrome (HLHS)

– a rare pediatric congenital heart birth defect in which the left ventricle (one of the pumping chambers of the heart) is either

severely underdeveloped or missing.

● Topline results from the Phase 2b clinical trial

(ELPIS II) evaluating laromestrocel as a potential adjunct therapy for HLHS are anticipated in August 2026.

● In May, the Company announced that the U.S. Food

and Drug Administration (FDA) held a Type C meeting in late March 2026 focused on the ELPIS II Phase 2b clinic trial and upcoming data

readout.

● ELPIS II is being conducted in collaboration

with the National Heart, Lung, and Blood Institute (NHLBI) through grants from the National Institutes of Health (NIH).

● The FDA has granted laromestrocel Orphan Drug

designation, Fast Track designation, and Rare Pediatric Disease designation for the treatment of HLHS.

Alzheimer’s disease (AD) –

a neurodegenerative disorder that leads to progressive memory loss and death and currently has very limited therapeutic options.

● Laromestrocel data from the Phase 2a clinical

trial (CLEAR MIND) linking neuroinflammation to clinical outcomes in patients with mild Alzheimer’s disease were presented at the

18th Clinical Trials on Alzheimer’s Disease Conference (CTAD 2025) held in December 2025.

● Results from the Phase 2a clinical trial (CLEAR

MIND), which support the therapeutic potential of laromestrocel in the treatment of mild Alzheimer’s disease and provided evidence-based

support for further clinical development, were published in the peer-reviewed journal Nature Medicine in March 2025.

● Positive Type B meeting with FDA regarding pathway to BLA submission for

laromestrocel in Alzheimer’s disease held in March 2025 with alignment reached on proposed trial study design, population and endpoints

for a single Phase 2/3 clinical trial that, if positive, could be acceptable for BLA submission for Alzheimer’s disease.

● The FDA has granted laromestrocel both Regenerative Medicine Advanced Therapy

(RMAT) designation and Fast Track designation for the treatment of mild Alzheimer’s disease.

● The Company is seeking to forge strategic collaborations and/or partnerships

for the advancement of laromestrocel in addressing AD.

Pediatric Dilated Cardiomyopathy (PDCM)

– a rare pediatric cardiovascular disease in which the muscles in one or more of the heart chambers become enlarged or stretched

(dilated), with nearly 40% of children with PDCM requiring a heart transplant or dying within two years of diagnosis.

● Longeveron’s Investigational New Drug (IND)

application for its stem cell therapy laromestrocel as a potential treatment for PDCM became effective in July 2025. This IND provides

for moving directly to a single Phase 2 registrational clinical trial.

● The Company currently anticipates initiation

of the Phase 2 clinical trial in 2027, with planning and preparation beginning in 2026.

Partnering Strategy

Laromestrocel represents a pipeline in a product

opportunity that has delivered positive initial results from multiple clinical trials across several indications. Our stem cell therapy

development programs address life-threatening conditions in the most vulnerable populations - children and the elderly: Hypoplastic Left

Heart Syndrome; Alzheimer’s disease; Pediatric Dilated Cardiomyopathy and Aging-related Frailty (AF). These four initial indications

address market opportunities of what we estimate to be approximately ~$1 billion, ~$5+ billion, up to ~$1 billion, and ~$4 billion, respectively.

We plan to pursue a robust partnering strategy across our development programs to accelerate potential time to market, increase capital

use efficiency and leverage the greater resources of larger organizations.

- HLHS: If the Phase 2b ELPIS II trial in HLHS is successful and the trial results and other available

evidence are deemed sufficient by the FDA to support filing a BLA following the readout of the top-line results, then we would intend

to pursue a potential BLA filing with the FDA and a commercialization partner.

- AD: We plan to leverage the strength of our Phase 2 data and clarity on the clinical pathway to a potential BLA for AD to engage

with potential funding/commercialization partners.

- PDCM: We plan to conduct a single Phase 2 registrational clinical trial in accordance with the

Investigational New Drug (IND) application which became effective in July 2025. If this trial is successful, we would then seek to partner

the program for further development and potential commercialization.

- AF: Results from our AF Phase 2b clinical, which were published in Cell Stem Cell, further

reinforce the strength and credibility of laromestrocel’s clinical data sets and provide an engagement point for discussions with

potential strategic partners to further advance this important but underserved development area.

2

Longeveron will participate in the BIO International

Convention taking place June 22-25, 2026 at the San Diego Convention Center. Stephen Willard, CEO, Dr. Joshua Hare, Founder, CSO and Executive

Chairman, and Than Powell, Business Development, will host meetings with global pharmaceutical company executives to explore potential

partnership and strategic opportunities for the Company’s four stem cell development programs.

First Quarter Corporate Updates

● In January, the Company announced that the Japan

Patent Office granted a patent covering potency assay methods for assessing human mesenchymal stem cells (MSCs) derived from bone marrow,

adipose tissue, peripheral blood, a lung, a heart, amniotic fluid, inner organs, an amniotic membrane, an umbilical cord or a placenta

or differentiated from induced pluripotent stem cells (IPSCs).

● In February 2026, the Company announced that

its Board of Directors appointed Stephen H. Willard as Chief Executive Officer. Mr. Willard has a 30+ year track record of leadership

across public and private sectors as CEO of multiple biotechnology and pharmaceutical firms, with a history of delivering significant

fundraises and strategic collaborations.

● In February 2026, the Company implemented cash-saving

measures to manage cash utilization and extend cash runway.

● In March 2026, Mr. Richard Kender provided notice

of his resignation from the Company’s Board of Directors and Audit Committee, effective immediately, due to his assuming the roles

of Executive Chairman and Interim CEO of Seres Therapeutics, Inc.

● In March 2026, the Company completed a private

placement of up to $30 million; $15 million up front with a milestone-driven potential additional $15 million related to the results of

the Company’s Phase 2b ELPIS II clinical trial in HLHS and share price. The private placement was led by Coastlands Capital with

participation from Janus Henderson Investors, Logos Capital and Kalehua Capital.

2026 First Quarter Summary Financial Results

● Revenues, Cost of Revenues

and Gross Profit: Revenues for the three months ended March 31, 2026 were $0.4 million and consisted of $0.4 million of clinical

trial revenues and $20,000 of contract manufacturing revenues. Revenues for the three months ended March 31, 2025 were $0.4 million and

consisted of $0.3 million of clinical trial revenues and $0.1 million of contract manufacturing revenues. Clinical trial revenues for

the three months ended March 31, 2026 increased $0.1 million, or 46%, when compared to the same period in 2025, as a result of greater

participant demand for our Bahamas Registry Trial. Contract manufacturing revenues for the three months ended March 31, 2026 decreased

$0.1 million, or 84%, when compared to the same period in 2025, driven by reduced demand for these services from our third-party client.

Related cost of revenues was $0.1 million

in each of the three months ended March 31, 2026 and 2025. This resulted in a gross profit of $0.3 million in each of the three months

ended March 31, 2026 and 2025.

● General and Administrative

Expenses: General and administrative expenses for the three months ended March 31, 2026 were $2.7 million, compared to $2.9 million

for the same period in 2025. The $0.2 million, or 7%, decrease was primarily due to a $0.4 million reduction in personnel and related

costs, reflecting lower performance achievement relating to 2025 annual cash incentive bonuses, partially offset by higher legal, accounting

and consulting fees.

3

● Research and Development Expenses: Research

and development expenses were $2.3 million for the three months ended March 31, 2026, compared to $2.5 million for the same period in

2025. The $0.2 million, or 8%, decrease was due to lower performance achievement relating to 2025 annual cash incentive bonuses and a

$0.2 million non-recurring charge for amortization expense related to patent costs recorded in the 2025 period, partially offset by a

year over year increase in personnel and higher clinical spend as we prepare for ELPIS II study results in August.

● Other Income: Other

income was $39,000 and $0.2 million for the three months ended March 31, 2026 and 2025, respectively, and consisted of interest earned

on money market funds. The decrease in other income of $0.2 million, or 77%, was due to declining cash balance.

● Net Loss: Net loss

was $4.7 million for the three months ended March 31, 2026, compared to $5.0 million for the three months ended March 31, 2025. The decrease

of $0.3 million, or 6%, was due to the factors outlined above.

● Cash and cash equivalents:

As of March 31, 2026, the Company had cash and cash equivalents of $15.8 million. We currently anticipate our existing cash and cash

equivalents will enable us to fund our operating expenses and capital expenditure requirements into the fourth quarter of 2026, based

on our current operating budget and cash flow forecast. Our operating costs will continue to be substantial for the foreseeable future

in connection with our ongoing activities. We intend to seek additional financing opportunities, capital raises, as well as non-dilutive

funding options to support our operating plans.

Conference Call and Webcast Details:

Conference Call Number:

1.877.407.0789

Conference ID:

13759888

Call meTM Feature:

Click Here

Webcast:

Click Here

An archived replay of the webcast will be available

on the “Events & Presentations” section of the Company’s website following the conference.

About Longeveron Inc.

Longeveron is a clinical stage biotechnology

company developing regenerative medicines to address unmet medical needs. The Company’s lead investigational product is laromestrocel

(Lomecel-BTM), an allogeneic mesenchymal stem cell (MSC) therapy product isolated from the bone marrow of young, healthy adult

donors. Laromestrocel has multiple potential mechanisms of action encompassing pro-vascular, pro-regenerative, anti-inflammatory, and

tissue repair and healing effects with broad potential applications across a spectrum of disease areas. Longeveron is pursuing four pipeline

indications: hypoplastic left heart syndrome (HLHS), Alzheimer’s disease, Pediatric Dilated Cardiomyopathy (DCM) and Aging-related

Frailty. Laromestrocel development programs have received five distinct and important FDA designations: for the HLHS program - Orphan

Drug designation, Fast Track designation, and Rare Pediatric Disease designation; and, for the AD program - Regenerative Medicine Advanced

Therapy (RMAT) designation and Fast Track designation. For more information, visit www.longeveron.com or follow Longeveron on LinkedIn,

X, and Instagram.

4

Forward-Looking Statements

Certain statements in this press release that

are not historical facts are forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation

Reform Act of 1995, which reflect management’s current expectations, assumptions, and estimates of future operations, performance

and economic conditions, and involve known and unknown risks, uncertainties, and other important factors that could cause actual results,

performance, or achievements to differ materially from those anticipated, expressed, or implied by the statements made herein. Forward-looking

statements are generally identifiable by the use of forward-looking terminology such as “anticipate,” “believe,”

“contemplate,” “continue,” “could,” “estimate,” “expects,” “intend,”

“looks to,” “may,” “on condition,” “plan,” “potential,” “predict,”

“preliminary,” “project,” “see,” “should,” “target,” “will,” “would,”

or the negative thereof or comparable terminology, although not all forward-looking statements contain these words, or by discussion of

strategy or goals or other future events, circumstances, or effects. Factors that could cause actual results to differ materially from

those expressed or implied in any forward-looking statements in this release include, but are not limited to, the ability of our clinical

trials to demonstrate safety and efficacy of our product candidates, and other positive results; our ability to successfully transition

toward a more capital-efficient, asset-light operating model; our ability to secure one or more strategic licensing partnerships for our

stem cell therapy laromestrocel in our development programs; the ability to reach alignment with the FDA on a potential path toward regulatory

approval; receipt of trial results and other available evidence sufficient to support the Company filing a BLA following the readout of

top-line results of the ELPIS II data; the timing and focus of our ongoing and future preclinical studies and clinical trials, and the

reporting of data from those studies and trials;; market and other conditions, our cash position and need to raise additional capital,

the difficulties we may face in obtaining access to capital, and the dilutive impact it may have on our investors; our financial performance,

and ability to continue as a going concern; the period over which we estimate our existing cash and cash equivalents will be sufficient

to fund our future operating expenses and capital expenditure requirements; the ability of our clinical trials to demonstrate safety and

efficacy of our investigational product candidates, and other positive results; the timing and focus of our ongoing and future preclinical

studies and clinical trials, and the reporting of data from those studies and trials; the size of the market opportunity for certain of

our investigational product candidates, including our estimates of the number of patients who suffer from the diseases we are targeting;

our ability to scale production and commercialize the investigational product candidate for certain indications; the success of competing

therapies that are or may become available; the beneficial characteristics, safety, efficacy and therapeutic effects of our investigational

product candidates; our ability to obtain and maintain regulatory approval of our investigational product candidates in the U.S. and other

jurisdictions; our plans relating to the further development of our investigational product candidates, including additional disease states

or indications we may pursue; our plans and ability to obtain or protect intellectual property rights, including extensions of existing

patent terms where available and our ability to avoid infringing the intellectual property rights of others; the need to hire additional

personnel and our ability to attract and retain such personnel; and our estimates regarding expenses, future revenue, capital requirements

and needs for additional financing.

Further information relating to factors that may

impact the Company’s results and forward-looking statements are disclosed in the Company’s filings with the Securities and

Exchange Commission, including Longeveron’s Annual Report on Form 10-K for the year ended December 31, 2025, filed with the Securities

and Exchange Commission on March 17, 2026, its Quarterly Reports on Form 10-Q, and its Current Reports on Form 8-K. The Company operates

in highly competitive and rapidly changing environment; therefore, new factors may arise, and it is not possible for the Company’s

management to predict all such factors that may arise nor assess the impact of such factors or the extent to which any individual factor

or combination thereof, may cause results to differ materially from those contained in any forward-looking statements. The forward-looking

statements contained in this press release are made as of the date of this press release based on information available as of the date

of this press release, are inherently uncertain, and the Company disclaims any intention or obligation, other than imposed by law, to

update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise.

Investor and Media Contact:

Derek Cole

Investor Relations Advisory Solutions

derek.cole@iradvisory.com

---tables follow---

5

Longeveron Inc.

Balance Sheets

(In thousands, except share and per share data)

March 31,

2026

December 31,

2025

(Unaudited)

Assets

Current assets:

Cash and cash equivalents

$ 15,758

$ 4,661

Prepaid expenses and other current assets

1,029

686

Accounts receivable

68

104

Total current assets

16,855

5,451

Property and equipment, net

1,651

1,836

Intangible assets, net

2,238

2,285

Operating lease asset, net

448

513

Other assets

18

176

Total assets

$ 21,210

$ 10,261

Liabilities and stockholders’ equity

Current liabilities:

Accounts payable

$ 293

$ 423

Accrued expenses

2,921

2,969

Current portion of lease liability

688

655

Deferred revenue

102

40

Other current liabilities

341

Total current liabilities

4,345

4,087

Long-term liabilities:

Long-term portion of operating lease liability

60

169

Liability related to the sale of future PRV proceeds

778

Other liabilities

330

Total long-term liabilities

838

499

Total liabilities

5,183

4,586

Stockholders’ equity:

Preferred stock, $0.001 par value per share, 4,973,025 shares authorized, no shares

issued and outstanding at March 31, 2026, and December 31, 2025

Series A non-voting convertible preferred stock, $0.001 par value per share, 26,975 shares authorized, 11,873 issued and outstanding at March 31, 2026, no shares issued and outstanding at December 31, 2025

Class A common stock, $0.001 par value per share, 84,295,000 shares authorized, 29,296,386 shares issued and outstanding at March 31, 2026; 21,445,336 issued   and outstanding at December 31, 2025

29

21

Class B common stock, $0.001 par value per share, 15,705,000 shares authorized, 1,484,005 shares issued and outstanding at March 31, 2026, and December 31, 2025

1

1

Additional paid-in capital

153,044

137,964

Accumulated deficit

(137,047 )

(132,311 )

Total stockholders’ equity

16,027

5,675

Total liabilities and stockholders’ equity

$ 21,210

$ 10,261

See accompanying notes to financial statements.

6

Longeveron Inc.

Statements of Operations

(In thousands, except per share data)

(Unaudited)

Three months ended

March 31,

2026

2025

Revenues

Clinical trial revenue

$ 378

$ 259

Contract manufacturing lease revenue

6

Contract manufacturing revenue

20

116

Total revenues

398

381

Cost of revenues

134

106

Gross profit

264

275

Operating expenses

General and administrative

2,720

2,941

Research and development

2,319

2,515

Total operating expenses

5,039

5,456

Loss from operations

(4,775 )

(5,181 )

Other income

Other income, net

39

170

Total other income, net

39

170

Net loss

$ (4,736 )

$ (5,011 )

Basic and diluted net loss per share

$ (0.19 )

$ (0.34 )

Basic and diluted weighted average common shares

outstanding

24,786,282

14,950,734

See accompanying notes to financial statements.

7

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Indicate if an emerging growth company has elected not to use the extended transition period for complying with any new or revised financial accounting standards.

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Commission file number. The field allows up to 17 characters. The prefix may contain 1-3 digits, the sequence number may contain 1-8 digits, the optional suffix may contain 1-4 characters, and the fields are separated with a hyphen.

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Two-character EDGAR code representing the state or country of incorporation.

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The exact name of the entity filing the report as specified in its charter, which is required by forms filed with the SEC.

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The Tax Identification Number (TIN), also known as an Employer Identification Number (EIN), is a unique 9-digit value assigned by the IRS.

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-Publisher SEC

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Local phone number for entity.

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Boolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act.

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Reference 1: http://www.xbrl.org/2003/role/presentationRef

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Boolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act.

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Title of a 12(b) registered security.

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Name of the Exchange on which a security is registered.

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Boolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as soliciting material pursuant to Rule 14a-12 under the Exchange Act.

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Trading symbol of an instrument as listed on an exchange.

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Boolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as written communications pursuant to Rule 425 under the Securities Act.

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