Form 8-K

8-K — Ocugen, Inc.

Accession: 0001104659-26-115921

Filed: 2026-10-15

Period: 2026-10-13

CIK: 0001372299

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

Item: Entry into a Material Definitive Agreement

Item: Regulation FD Disclosure

Item: Other Events

Item: Financial Statements and Exhibits

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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, DC 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 13, 2026

OCUGEN, INC.

(Exact Name of Registrant as Specified in its Charter)

Delaware

001-36751

04-3522315

(State or Other Jurisdiction of

Incorporation)

(Commission

File Number)

(IRS Employer

Identification No.)

11 Great Valley Parkway

Malvern,

Pennsylvania 19355

(Address of principal executive offices) (Zip

Code)

Registrant’s telephone number, including

area code (484) 328-4701

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, $0.01 par value per share

OCGN

The Nasdaq Stock Market LLC

(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 ¨

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 13, 2026, Ocugen, Inc. (the “Company”

or “Ocugen”) entered into an Exclusive License Agreement (the “License Agreement”) with Roots Pharmaceutical Company

WLL (“Roots”), pursuant to which Roots was granted an exclusive, non-sublicensable, royalty-bearing license to (i) make, have

made, manufacture, import, export, distribute, use, have used, keep, sell, have sold, or offer for sale, including to research, develop,

commercialize, register, modify, enhance, improve, or otherwise exploit OCU400 (the “licensed product”)—Ocugen’s

novel modifier gene therapy for retinitis pigmentosa (“RP”) in certain countries in the Middle East and North Africa (“the

Territory”) and (ii) to use the trademark selected by Ocugen in the Territory solely in connection with the licensed product in

gene therapy for the treatment of RP in humans.

Roots will have sole control over preparing, filing

and maintaining regulatory submissions and communicating with regulatory authorities in the Territory. Roots has agreed to use commercially

reasonable efforts to develop, seek, register and obtain regulatory approval for, and to commercialize, the licensed product in the Territory.

The Company will own the global safety database with respect to the licensed product.

Under the License Agreement, the Company will

receive (i) an up-front license fee and potential regulatory and development milestone payments of up to $4 million in the aggregate;

and (ii) payments upon achievement of certain sales milestones of up to $255.0 million. Additionally, Ocugen will receive a royalty of

22% on net sales of the licensed product generated by Roots in the Territory. On October 13, 2026, Ocugen and Roots also entered into

a commercial supply agreement, pursuant to which Ocugen will manufacture and supply the licensed product to Roots.

The License Agreement and the licenses granted

thereunder will continue in force until the last to occur of: (a) the 20 year anniversary of the date of the first commercial sale of

the licensed product in the Territory; (b) the expiration of the last valid claim of a patent right within the licensor patent rights

in the Territory; and (c) the expiration of the market exclusivity, including any regulatory exclusivity for the licensed product in the

Territory, and on such date the License Agreement and the licenses granted thereunder will terminate automatically. In addition, the License

Agreement contains customary termination provisions in the event of an uncured material breach or upon certain corporate actions or events,

including bankruptcy, receivership, or liquidation.

The foregoing summary of the material terms of

the License Agreement is qualified in its entirety by the terms of the License Agreement, a copy of which will be filed as an exhibit

to the Company’s Annual Report on Form 10-K for the fiscal year ending December 31, 2026 to be filed with the Securities and Exchange

Commission (the “SEC”).

Item 7.01 Regulation FD Disclosure.

On October 14, 2026, the Company issued a

press release announcing the execution of the License Agreement. A copy of the press release is furnished hereto as Exhibit

99.1 and is incorporated herein by reference. The information contained in this Item 7.01 and Exhibit 99.1 shall not be

deemed to be “filed” for the purposes of Section 18 of the Exchange Act, or otherwise subject to the liabilities of such

section, nor will such information be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended,

or the Securities Exchange Act of 1934, as amended, except as may be expressly set forth by specific reference in such filing.

Item 8.01 Other Events.

On October 14, 2026, the Board of Directors

(the “Board”) of the Company determined to postpone the Special Meeting of Stockholders of the Company (the “Special

Meeting”), which was previously adjourned to October 26, 2026, solely with respect to the proposal to approve the adoption of an

amendment to the Company’s Sixth Amended and Restated Certificate of Incorporation, as amended, to increase the number of authorized

shares of common stock, par value $0.01 per share, by 250,000,000 shares (“Proposal 1”). The Special Meeting is postponed

in order to provide additional time for stockholders to consider and vote on Proposal 1.

The Special Meeting will be held on Tuesday, December

22, 2026, at 8:00 am, Eastern Time, virtually at www.virtualshareholdermeeting.com/OCGN2026SM2.

The close of business on October 30, 2026 will

be the new record date for the determination of stockholders of the Company entitled to vote at the Special Meeting. The Company intends

to file Definitive Additional Materials on Schedule 14A with the SEC related to the Special Meeting.

STOCKHOLDERS ARE URGED TO READ THE PROXY STATEMENT

FILED BY THE COMPANY ON JULY 30, 2026, AS WELL AS DEFINITIVE ADDITIONAL MATERIALS AND ANY OTHER RELEVANT SOLICITATION MATERIALS WHEN THEY

BECOME AVAILABLE, CAREFULLY AND IN THEIR ENTIRETY BECAUSE THESE DOCUMENTS CONTAIN IMPORTANT INFORMATION CONCERNING PROPOSAL 1 TO BE VOTED

ON AT THE SPECIAL MEETING.

Item 9.01

Financial Statements and Exhibits.

(d) Exhibits

Exhibit

No.

Document

99.1

Press Release of the Company, dated October 14, 2026.

104

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

SIGNATURE

Pursuant to the requirements of the Securities

Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly

authorized.

Date: October 14, 2026

OCUGEN, INC.

By:

/s/ Shankar Musunuri

Name: Shankar Musunuri

Title: Chairman, Chief Executive Officer, & Co-Founder

EX-99.1 — EXHIBIT 99.1

EX-99.1

Filename: tm2627592d1_ex99-1.htm · Sequence: 2

Exhibit 99.1

Ocugen and Roots Pharmaceutical Complete License Agreement for OCU400

Modifier Gene Therapy for Retinitis Pigmentosa in the Middle East and North Africa

October 14, 2026

Establishes strategic commercial reach across the Middle East and North Africa, advancing Ocugen’s goal of enabling global patient access to potentially transformational gene therapies

Expands access to a potential one-time gene therapy for retinitis pigmentosa in a region with high disease prevalence and substantial unmet need

Agreement includes upfront license fee and initial development payments up to $4 million, potential sales milestones up to $255 million, and royalties equaling 22% of net sales; Ocugen will manufacture and supply OCU400

MALVERN, Pa., Oct. 14, 2026 (GLOBE NEWSWIRE) -- Ocugen, Inc. (“Ocugen”

or the “Company”) (NASDAQ: OCGN), a pioneering biotechnology leader in gene therapies for blindness diseases, today announced

the execution of a licensing agreement with Roots Pharmaceutical, and its strategic partner Al-Dhow International Holding, for the exclusive

rights to OCU400, Ocugen's novel modifier gene therapy for the treatment of Retinitis Pigmentosa (RP), in the Middle East and North Africa

(MENA) region.

Subject to the terms of the License Agreement, Ocugen will receive

an upfront license fee and potential initial development milestone payments of up to $4 million, in the aggregate, as well as potential

sales milestone payments of up to $255 million, and royalties equaling 22% of OCU400 net sales generated by Roots Pharmaceutical. Ocugen

will manufacture the commercial supply of OCU400 under terms of a related supply agreement.

Ocugen believes RP is a leading cause of inherited vision loss globally,

with a particularly significant unmet need across the MENA region, where the prevalence of RP is estimated to be 10 to 20 times higher

than in the U.S. and EU. Through OCU400, Roots Pharmaceutical aims to help address this substantial unmet need by potentially providing

a treatment option for people in the MENA region living with RP and facing progressive vision loss and potential blindness.

“By partnering with Roots Pharmaceutical,

an established leader with strong reach across the Middle East and North Africa, we are expanding our ability to bring our potential one-time

gene therapy to patients in a region where retinitis pigmentosa is highly prevalent and the unmet medical need is significant,”

said Dr. Shankar Musunuri, Chairman, Chief Executive Officer and Co-founder of Ocugen. “This agreement represents another important

step in our strategy to build strong regional partnerships and expand global access to our potentially transformational gene therapies.”

Roots Pharmaceutical is an established and rapidly growing pharmaceutical

company serving key markets across the MENA region. With more than two decades of operating experience and expertise in commercializing

innovative medicines, the company’s regional capabilities and established healthcare relationships position it as a strong partner

for bringing OCU400 to RP patients across MENA.

"This partnership reflects Roots' commitment to bringing breakthrough

gene therapies to the Middle East and North Africa, leading and shaping the treatment paradigm for our patients, which is our main objective,"

said Dr. Islam Zayed, Chief Executive Officer and Co-Founder of Roots Pharmaceutical. "OCU400 has the potential to change the outlook,

and the lives, of patients living with retinitis pigmentosa. We look forward to working closely with Ocugen to build the diagnosis-to-treatment

pathway that gene therapy requires across our markets, and to exploring further collaboration across Ocugen's ophthalmology pipeline."

Ocugen continues to advance OCU400 through its Phase 3 liMeliGhT clinical

trial with a topline data readout expected in the first quarter of 2027, followed by global regulatory submissions, including a Biologics

License Application in the U.S. and a Marketing Authorization Application in Europe.

About Ocugen, Inc.

Ocugen, Inc. is a pioneering biotechnology company developing gene

therapies for blindness diseases. The Company’s breakthrough modifier gene therapy platform has the potential to address significant

unmet medical needs across large patient populations through a gene-agnostic approach. Unlike traditional gene therapies and gene-editing

technologies that target a single gene mutation, Ocugen’s modifier gene therapies are designed to address the underlying disease

biology by restoring balance across multiple gene networks. The Company is currently advancing programs for inherited retinal diseases

and other causes of blindness that affect millions worldwide, including retinitis pigmentosa, Stargardt disease, and geographic atrophy,

an advanced form of dry age-related macular degeneration. Discover more at www.ocugen.com and follow the Company on LinkedIn

and X.

About Roots Pharmaceutical Company

Founded in Kuwait in 2006, Roots Pharmaceutical

is a fully integrated healthcare provider specializing in commercializing innovative therapies, medical devices, and an aesthetic line

across the Middle East and North Africa. It is led by a team with over 25 years of pharmaceutical industry experience.

Roots Pharmaceuticals has established a direct commercial presence

in the MENA region (Middle East and North Africa), mainly in GCC countries and key North African countries, with a therapeutic portfolio

spanning neurology, hematology, oncology, rare diseases, dermatology, cardiovascular, medical devices and aesthetic line.

With 30+ global partners and a $300M+ product pipeline, Roots Pharmaceutical

and its strategic partner Al-Dhow Group are committed to delivering meaningful healthcare impact across the MENA region through innovation,

access and excellence. Its operations are ISO 9001:2015-certified and externally audited by PwC.

Cautionary Note on Forward-Looking Statements

This press release contains forward-looking

statements within the meaning of The Private Securities Litigation Reform Act of 1995, including, but not limited to, statements

regarding the anticipated benefits to Ocugen of the definitive license agreement and supply agreement with Roots Pharmaceutical

Company, as well as statements regarding strategy, the potential amounts of milestone payments and royalty payments that may be

received under the license agreement, business plans and objectives for Ocugen’s clinical programs, plans and timelines for

the preclinical and clinical development of Ocugen’s product candidates, including the therapeutic potential, clinical

benefits and safety thereof, expectations regarding timing, success and data announcements of current ongoing preclinical and

clinical trials, including the timing of data readouts and marketing applications, the ability to initiate new clinical programs,

statements regarding qualitative assessments of available data, potential benefits, expectations for ongoing clinical trials,

anticipated regulatory filings and anticipated development timelines, statements regarding potential market size and commercial

possibilities of Ocugen’s product candidates, which are subject to risks and uncertainties. Ocugen may, in some cases, use

terms such as “predicts,” “believes,” “potential,” “proposed,”

“continue,” “estimates,” “anticipates,” “expects,” “plans,”

“intends,” “may,” “could,” “might,” “will,” “should,” or

other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Such statements are

subject to numerous important factors, risks, and uncertainties that may cause actual events or results to differ materially from

Ocugen’s current expectations, including, but not limited to, the risks that the license agreement and supply agreement with

Roots Pharmaceutical Company will not lead to the current anticipated benefits to Ocugen; that preliminary, interim and top-line

clinical trial results may not be indicative of, and may differ from, final clinical data; that unfavorable new clinical trial data

may emerge in ongoing clinical trials or through further analyses of existing clinical trial data; that earlier non-clinical and

clinical data and testing may not be predictive of the results or success of later clinical trials; and that clinical trial data are

subject to differing interpretations and assessments, including by regulatory authorities. These and other risks and uncertainties

are more fully described in Ocugen’s filings with the Securities and Exchange Commission (SEC), including the risk factors

described in the section entitled “Risk Factors” in the quarterly and annual reports that Ocugen files with the SEC. Any

forward-looking statements that Ocugen makes in this press release speak only as of the date of this press release. Except as

required by law, Ocugen assumes no obligation to update forward-looking statements contained in this press release whether as a

result of new information, future events, or otherwise, after the date of this press release.

Contacts:

Investors:

Candice Masse, astr partners

candice.masse@astrpartners.com

Media:

Chris Clark, Ocugen

chris.clark@ocugen.com

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