Form 8-K

8-K — Outlook Therapeutics, Inc.

Accession: 0001104659-26-096478

Filed: 2026-08-14

Period: 2026-08-14

CIK: 0001649989

SIC: 2836 (BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES))

Item: Results of Operations and Financial Condition

Item: Financial Statements and Exhibits

Documents

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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): August 14, 2026

Outlook Therapeutics,

Inc.

(Exact

name of registrant as specified in its charter)

Delaware

001-37759

38-3982704

(State or other jurisdiction

of incorporation)

(Commission File Number)

(IRS Employer Identification No.)

111

S. Wood Avenue,

Unit

#100

Iselin, New Jersey

08830

(Address of principal executive offices)

(Zip Code)

Registrant's telephone number, including area code:

(609) 619-3990

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 pursuant to Section 12(b) of the Act:

Title of Each Class

Trading Symbol(s)

Name of Each Exchange

on Which

Registered

Common Stock

OTLK

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

2.02 Results

of Operations and Financial Condition

On August 14, 2026, Outlook Therapeutics,

Inc. (the “Company”) issued a press release announcing its financial results for its second fiscal quarter ended June 30,

2026. A copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K. In addition, the Company will post

a business update slide presentation from the earnings call accompanying the earnings release on its website.

The information contained in this

Item 2.02 and in the accompanying Exhibit 99.1 shall not be deemed filed for purposes of Section 18 of the Securities Exchange Act of

1934, as amended (the “Exchange Act”), or incorporated by reference in any filing under the Exchange Act or the Securities

Act of 1933, as amended, except as shall be expressly set forth by specific reference in such filing.

Item 9.01 Financial Statements and Exhibits

(d) Exhibits

Exhibit No.

Description

99.1

Press Release dated August 14, 2026

104

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

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.

Outlook Therapeutics, Inc.

Date: August 14, 2026

By:

/s/ Lawrence A. Kenyon

Lawrence A. Kenyon

Chief Financial Officer

EX-99.1 — EXHIBIT 99.1

EX-99.1

Filename: tm2622399d3_ex99-1.htm · Sequence: 2

Exhibit 99.1

Outlook Therapeutics Reports Third Quarter

Fiscal Year 2026 Financial Results

and Provides Business Update Highlighting FDA Approval of LYTENAVA™

The

only FDA-approved ophthalmic bevacizumab, LYTENAVATM, addresses a significant need in the U.S. wet AMD market

where bevacizumab is already widely used

Advancing the U.S. launch strategy for LYTENAVA,

including broad market access, reimbursement, pricing, medical affairs, and supply capabilities

Potential to exceed $500 million in annual

U.S. LYTENAVA sales by 2030

Company to host corporate update conference

call today, August 14th, at

8:30

AM ET — registration details below

ISELIN,

N.J., August 14, 2026 — Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company focused

on the development and commercialization of LYTENAVA™ (bevacizumab-vikg, bevacizumab gamma) for the treatment of retinal diseases,

today reported financial results for the third quarter of fiscal year 2026, ended June 30, 2026, and provided a business update.

The Company continues to advance preparations for the U.S. commercial launch of LYTENAVA, the only FDA-approved ophthalmic bevacizumab

for the treatment of wet age-related macular degeneration (wet AMD).

“FDA approval of LYTENAVA marks a defining

moment for Outlook Therapeutics and creates a significant opportunity for the Company in the United States,” said Bob Jahr, Chief

Executive Officer of Outlook Therapeutics. “Our priorities are clear: build an exceptional commercial team with deep retina and

launch experience, prepare for our planned U.S. launch by the end of calendar 2026, and execute a strategy that reflects today’s

competitive and evolving wet AMD treatment landscape. We believe LYTENAVA is well positioned to become an important treatment option

for retina physicians and their patients.”

Outlook Therapeutics is advancing preparations

for the U.S. commercial launch of LYTENAVA, planned before the end of calendar 2026. The Company is expanding payer engagement, scaling

commercial supply, and building a focused commercial organization informed by feedback from retina physicians, practices, and other key

stakeholders. Based on current estimates, management believes LYTENAVA has the potential to exceed $500 million in annual U.S. sales

by 2030.

The Company has established its customer segmentation

and targeting strategy to prioritize retina practices with the greatest potential for early adoption and is building its commercial team

with experienced leaders with deep expertise in retina, product launches, and the increasingly competitive and complex wet AMD and anti-VEGF

market. The Company’s launch and go-to-market strategy is designed to reflect the evolving biosimilar landscape, affordability

considerations, and the potential for additional market entrants, while supporting broad patient access and reimbursement. As part of

these efforts, the Company plans to submit an application for a permanent Healthcare Common Procedure Coding System or HCPCS code by

October 1, 2026, to support reimbursement following launch.

“Our launch strategy reflects a deep understanding

of the retina market and the needs of patients, physicians, practices, and payers,” continued Mr. Jahr. “We are taking

a targeted approach to customer engagement, pricing, and reimbursement, while building the commercial and supply capabilities needed

to support the introduction of LYTENAVA in the United States. We believe this foundation will position us to drive broad access and successful

adoption following launch.”

In Europe, Outlook Therapeutics continues to

expand the commercialization of LYTENAVA in Germany, Austria and the United Kingdom. The Company is also preparing for a planned launch

in the Netherlands later in 2026 following its Netherlands submission. In Switzerland, the Company’s partner, Mediconsult, is leading

regulatory and commercial activities in support of an anticipated launch in 2027.

Wet AMD remains a leading cause of vision loss

among older adults, and anti-VEGF therapies represent the current standard of care for millions of patients worldwide. At the center

of the Company’s strategy is a commitment to ensuring broad patient access and reimbursement while removing barriers to adoption

for both patients and practices.

“For retina practices, the approval of

LYTENAVA represents more than a new treatment option. It addresses a longstanding need for an FDA-approved bevacizumab specifically for

ophthalmic use. The patient services and support resources available alongside LYTENAVA can also help practices navigate access and support

eligible patients with wet AMD throughout their treatment journey,” said Albert Shirakian, CEO, Retina Vitreous Associates Medical

Group.

“We have been working closely with the

Outlook Therapeutics team since LYTENAVA received FDA approval and appreciate their commitment to meeting a longstanding need in retina

care. Having an FDA-approved bevacizumab specifically for ophthalmic use gives physicians an important new option, supported by the clinical

data and quality standards of the FDA approval process. We are encouraged by this new treatment option for physicians and patients in

the treatment of wet AMD,” stated Miguel A. Busquets, MD, FACS, FASRS, Vice Chairman, EyeCare Partners.

Financial Results for the Third Quarter Fiscal

Year 2026 ended June 30, 2026

For the third fiscal quarter ended June 30,

2026, Outlook Therapeutics reported net loss attributable to common stockholders of $20.3 million, or $0.15 per basic and diluted share.

This compares with net loss attributable to common stockholders of $20.2 million, or $0.55 per basic and diluted share for the same period

last year.

For the fiscal quarter ended June 30, 2026,

Outlook Therapeutics reported an adjusted net loss attributable to common stockholders of $10.9 million, or $0.09 per basic and diluted

share, as compared to an adjusted net loss attributable to common stockholders of $15.8 million, or $0.44 per basic and diluted share

for the third fiscal quarter of 2025.

Adjusted net loss attributable to common stockholders

for the fiscal quarter ended June 30, 2026, excludes $1.1 million of loss from change in fair value of promissory notes, $1.3 million

of loss on extinguishment of debt, and $7.0 million of loss from change in fair value of warrant liability. Adjusted net loss attributable

to common stockholders for the fiscal quarter ended June 30, 2025, excludes $2.0 million of loss from change in fair value of warrant

liability, and $2.3 million of loss from change in fair value of promissory notes.

Subsequent to the quarter end, in August 2026,

the Company announced a public offering of 55,555,556 shares of common stock and accompanying warrants to purchase 55,555,556 shares

of common stock, at a combined public offering price of $0.99 per share and accompanying warrant, for approximately $51.1 million of

net proceeds, after deducting underwriting discounts and commissions and other estimated offering expenses. As of June 30, 2026,

Outlook Therapeutics had cash and cash equivalents of $11.2 million, which does not include the proceeds from the public offering.

Conference Call and Webcast

As previously announced, Outlook Therapeutics

will host a conference call and webcast to discuss the Company’s third quarter fiscal year 2026 operational and financial results

today, August 14, 2026, at 8:30 AM ET.

The

call will be hosted by members of Outlook Therapeutics’ leadership team, Bob Jahr, Chief Executive Officer and Lawrence A. Kenyon,

Executive Vice President and Chief Financial Officer. Interested participants and investors may access the conference call by dialing

877-407-8291 (domestic) or +1 201-689-8345 (international) and referencing the Outlook Therapeutics conference call. The webcast will

be accessible here and will be archived following the live event.

About LYTENAVA™ (bevacizumab-vikg, bevacizumab

gamma)

LYTENAVA™ is an ophthalmic formulation

of bevacizumab produced in the United States for the treatment of wet AMD. In the United States, ONS-5010/LYTENAVA (bevacizumab-vikg)

is the only ophthalmic formulation approved by the FDA. LYTENAVA™ (bevacizumab gamma) is also the subject of a centralized Marketing

Authorization granted by the European Commission in the EU and Marketing Authorization granted by the Medicines and Healthcare

products Regulatory Agency (MHRA) in the UK for the treatment of wet AMD. In certain European Union Member States, LYTENAVA™

must receive pricing and reimbursement approval before it can be sold.

Bevacizumab-vikg (bevacizumab gamma in the EU

and UK) is a recombinant humanized IgG1 monoclonal antibody specific tofor human vascular endothelial growth factor (VEGF). Bevacizumab

binds VEGF and prevents the interaction of VEGF to its receptors (Flt-1 and KDR) on the surface of endothelial cells. LYTENAVA binds

to all isoforms of VEGF-A, thereby preventing interaction with receptors VEGFR-1 and VEGFR-2. By inhibiting VEGF-A, LYTENAVA suppresses

endothelial cell proliferation, neovascularization, and vascular permeability. Inhibition of such activity targets a pathophysiologic

process that contributes to vision loss.

Important Safety Information and Indication

LYTENAVA (bevacizumab-vikg) is a vascular endothelial

growth factor (VEGF) inhibitor indicated for the treatment of patients with neovascular (wet) age-related macular degeneration (nAMD).

Contraindications

LYTENAVA is contraindicated in patients with ocular or periocular infections, in patients with active intraocular inflammation,

and in patients with a known hypersensitivity to bevacizumab products or any of the ingredients in LYTENAVA. Hypersensitivity reactions

may manifest as severe intraocular inflammation.

Warnings and Precautions

Intravitreal injections have been associated

with endophthalmitis and retinal detachments. Proper aseptic injection technique must always be used when administering LYTENAVA. In

addition, patients should be monitored following the injection to permit early treatment should an infection occur.

Increases in intraocular pressure have been noted

post-injection (up to 60 minutes) while being treated with LYTENAVA. Monitor intraocular pressure prior to and following intravitreal

injection with LYTENAVA and manage appropriately.

Although there was a low rate of arterial thromboembolic

events (ATEs) observed in the LYTENAVA clinical trials, there is a potential risk of ATEs following intravitreal use of VEGF inhibitors.

ATEs are defined as nonfatal stroke, nonfatal myocardial infarction, or vascular death (including deaths of unknown cause).

Adverse Reactions

The most common adverse reaction (≥1%) reported

in patients receiving LYTENAVA was conjunctival hemorrhage (4%), eye pain (2%), and vitreous floaters (2%). These are not all the possible

side effects of LYTENAVA.

You are encouraged to report side effects of

prescription drugs to the FDA.

Visit www.fda.gov/medwatch or

call 1-800-FDA-1088. You may also report side effects to Outlook Therapeutics at 1-833-999-OTLK (6855).

Please

see the full U.S. Prescribing Information for LYTENAVA here.

About Outlook Therapeutics, Inc.

Outlook Therapeutics is a biopharmaceutical company

focused on the development and commercialization of LYTENAVA (bevacizumab-vikg (U.S.), bevacizumab gamma (E.U.)). LYTENAVA is the only

ophthalmic formulation of bevacizumab to receive U.S. FDA approval and European Commission and MHRA Marketing Authorization for the treatment

of wet AMD. Outlook Therapeutics commenced commercial launch of LYTENAVA™ (bevacizumab gamma) in Germany, Austria, and the UK as

a treatment for wet AMD.

Non-GAAP Financial Measures

Outlook Therapeutics prepares its consolidated

financial statements in conformity with accounting principles generally accepted in the United States of America (U.S. GAAP) and pursuant

to accounting requirements of the Securities and Exchange Commission (SEC). In an effort to provide investors with additional information

regarding the results and to provide a meaningful period-over-period comparison of Outlook Therapeutics’ financial performance,

Outlook Therapeutics sometimes uses non-U.S. GAAP financial measures (NGFM) as defined by the SEC. In this press release, Outlook Therapeutics

uses “adjusted net loss attributable to common stockholders,” which is defined as net loss attributable to common stockholders

excluding loss on extinguishment of debt and changes in fair value of warrants and convertible promissory notes, as well as “adjusted

net loss attributable to common stockholders per share of common stock – basic and diluted,” which is defined as net loss

attributable to common stockholders per share of common stock – basic and diluted, excluding loss on extinguishment of debt and

changes in fair value of warrants and convertible promissory notes. Management uses these NGFMs because they adjust for certain non-cash

items that impact financial results but not cash flows, and that management believes are not related to its core business. Management

uses these NGFMs to evaluate Outlook Therapeutics’ financial performance against internal budgets and targets. Management believes

that these NGFMs are useful for evaluating Outlook Therapeutics’ core operating results and facilitating comparison across reporting

periods. Outlook Therapeutics believes these NGFMs should be considered in addition to, and not in lieu of, GAAP financial measures.

Outlook Therapeutics’ NGFMs may be different from the same NGFMs used by other companies. Reconciliations to the closest U.S. GAAP

financial measures are provided in the tables below.

Forward-Looking Statements

This press release contains statements that may

or are considered “forward-looking statements”. All statements other than statements of historical facts are “forward-looking

statements,” including those relating to future events. In some cases, you can identify forward-looking statements by terminology

such as “anticipate,” “believe,” “can,” “could,” “continue,” “expect,”

“may,” “on track,” “plan,” “potential,” “target,” “will,” or

“would”, the negative of terms like these or other comparable terminology, and other words or terms of similar meaning. These

include, among others, express or implied discussions regarding the Company’s planned launch of LYTENAVA in the United States and

other jurisdictions and the timing thereof; expectations concerning potential revenue generation from sales of LYTENAVA; expectations

surrounding market adoption of LYTENAVA; potential additional marketing approvals; expectations regarding the potential impact of LYTENAVA

in the retina community; new indications or labeling for LYTENAVA; Outlook Therapeutics development or future revenue plans for LYTENAVA

generally; and other statements that are not historical fact. Although Outlook Therapeutics believes that it has a reasonable basis for

the forward-looking statements contained herein, they are based on current expectations about future events affecting Outlook Therapeutics

and are subject to risks, uncertainties, and factors relating to its operations and business environment, all of which are difficult

to predict and many of which are beyond its control. These risk factors include those risks associated with developing and commercializing

pharmaceutical product candidates, risks in obtaining necessary regulatory approvals, the content and timing of decisions by regulatory

bodies, as well as those risks detailed in Outlook Therapeutics’ filings with the Securities and Exchange Commission (the SEC),

including the Current Report on Form 8-K filed with the SEC on August 12, 2026, and future reports Outlook Therapeutics files

with the SEC, which include uncertainty of market conditions and future impacts related to macroeconomic factors, including as a result

of the ongoing overseas conflicts, tariffs, and trade tensions, fluctuations in interest rates and inflation, and potential future bank

failures on the global business environment. These risks may cause actual results to differ materially from those expressed or implied

by forward-looking statements in this press release. All forward-looking statements included in this press release are expressly qualified

in their entirety by the foregoing cautionary statements. You are cautioned not to place undue reliance on these forward-looking statements,

which speak only as of the date hereof. Outlook Therapeutics does not undertake any obligation to update, amend, or clarify these forward-looking

statements, whether as a result of new information, future events, or otherwise, except as may be required under applicable securities

law.

Investor Inquiries:

Jenene Thomas

Chief Executive Officer

JTC Team, LLC

T: 908.824.0775

Outlook Therapeutics, Inc.

Consolidated Statements of Operations

(Amounts in thousands, except per share data)

Three months

ended June 30,

Nine months

ended June 30,

2026

2025

2026

2025

Revenues, net

$ 9

$ 1,505

$ (1,071 )

$ 1,505

Cost of revenues

440

196

440

Gross profit

(8 )

1,065

(1,267 )

1,065

Operating expenses:

Research

and development

$ 3,251

$ 7,135

11,386

21,202

Selling,

general and administrative

7,551

9,679

25,668

29,610

Loss from operations

(10,810 )

(15,749 )

(38,321 )

(49,747 )

Loss on equity method investment

125

100

Interest expense

—

Loss from change in fair value of promissory

notes

1,103

2,324

5,351

5,739

Warrant inducement expenses

—

33,857

Loss (gain) from change in fair value of

warrant liability

7,036

2,000

2,990

(40,333 )

Loss on extinguishment

of debt

1,329

—

1,043

—

Net loss before

income tax

$ (20,319 )

$ (20,152 )

(47,830 )

$ (49,129 )

Income tax expense

—

Net loss

(20,319 )

(20,152 )

(47,830 )

(49,132 )

Per share information:

Net loss per share

of common stock, basic and diluted

$ (0.15 )

$ (0.55 )

$ (0.51 )

$ (1.60 )

Weighted average shares outstanding,

basic and diluted

136,743

36,957

93,232

30,664

Condensed Consolidated Balance Sheet Data

(Amounts in thousands)

June 30,

2026

September 30,

2025

Cash and cash equivalents

$ 11,242

$ 8,083

Total assets

$ 26,185

$ 18,584

Current liabilities

$ 28,679

$ 45,815

Total stockholders' deficit

$ (10,393 )

$ (32,188 )

Reconciliation Between Reported Net Loss (GAAP)

and Adjusted Net Loss (Non-GAAP), in each case

Attributable to Common Stockholders

(Amounts in thousands, except per share data)

Three months

ended June 30,

Nine months

ended June 30,

2026

2025

2026

2025

Net loss attributable to common stockholders,

as reported (GAAP)

$ (20,319 )

$ (20,152 )

$ (47,830 )

$ (49,132 )

Adjustments for reconciled items:

Loss from change in fair value of promissory

notes

1,102

2,324

5,351

5,739

Warrant inducement expenses

—

33,857

Loss (gain) from change in fair value

of warrant liability

7,036

2,000

2,990

(40,333 )

Loss on extinguishment

of debt

1,329

—

1,043

—

Adjusted net loss attributable

to common stockholders (non-GAAP)

$ (10,852 )

$ (15,828 )

$ (38,446 )

$ (49,869 )

Net loss attributable to common stockholders per share

of common stock - basic as reported (GAAP)

$ (0.15 )

$ (0.55 )

$ (0.51 )

$ (1.60 )

Adjustments for reconciled items:

Loss from change in fair value of promissory

notes

0.01

0.06

0.19

Warrant inducement expenses

—

1.10

Loss (gain) from change in fair value

of warrant liability

0.05

0.03

(1.32 )

Loss on extinguishment

of debt

0.01

Adjusted net loss attributable to common stockholders

per share of common stock - basic (non-GAAP)

$ (0.09 )

$ (0.44 )

$ (0.42 )

$ (1.63 )

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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.

+ References

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

-Publisher SEC

-Name Exchange Act

-Number 240

-Section 12

-Subsection b-2

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- Definition

Local phone number for entity.

+ References

No definition available.

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- Definition

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.

+ References

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

-Publisher SEC

-Name Exchange Act

-Number 240

-Section 13e

-Subsection 4c

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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.

+ References

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

-Publisher SEC

-Name Exchange Act

-Number 240

-Section 14d

-Subsection 2b

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- Definition

Title of a 12(b) registered security.

+ References

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

-Publisher SEC

-Name Exchange Act

-Number 240

-Section 12

-Subsection b

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- Definition

Name of the Exchange on which a security is registered.

+ References

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

-Publisher SEC

-Name Exchange Act

-Number 240

-Section 12

-Subsection d1-1

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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.

+ References

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

-Publisher SEC

-Name Exchange Act

-Number 240

-Section 14a

-Subsection 12

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Trading symbol of an instrument as listed on an exchange.

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No definition available.

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- Definition

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.

+ References

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

-Publisher SEC

-Name Securities Act

-Number 230

-Section 425

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