Ocugen licenses OCU400; potential $255M sales milestones
Roots will control regulatory submissions in the territory, while Ocugen will own the global safety database and manufacture the commercial supply.
Sentiment and the balance of points
Rhea-AI Sentiment reads the wording of the document, how positive or negative its language is on a 1 to 5 scale. The balance of points shown with the takes weighs what the document actually discloses, so the two can disagree, for example when a trial that missed its main goal is described in upbeat language.
Rhea-AI Filing Summary
Ocugen, Inc. (OCGN) granted Roots Pharmaceutical Company WLL an exclusive, non-sublicensable, royalty-bearing license to develop and commercialize OCU400 for retinitis pigmentosa in certain Middle East and North Africa countries. Ocugen is to receive an upfront license fee, potential regulatory and development milestone payments of up to $4 million in the aggregate, potential sales milestone payments of up to $255.0 million, and a 22% royalty on net sales in the territory. Under a separate commercial supply agreement, Ocugen will manufacture and supply the product.
Roots will control regulatory submissions in the territory, while Ocugen will own the global safety database. The company also postponed its special meeting to December 22, 2026, with October 30, 2026 as the new record date, to allow more time for stockholders to consider a proposal to increase authorized common shares by 250,000,000. OCU400 remains in a Phase 3 trial, with topline data expected in the first quarter of 2027.
Insights
Analyzing...
8-K Event Classification
Key Figures
Key Terms
royalty-bearing license financial
regulatory and development milestone payments financial
global safety database technical
Biologics License Application regulatory
Marketing Authorization Application regulatory
FAQ
AI-generated questions and answers. How Rhea-AI works. Not financial advice.
What payments could Ocugen (OCGN) receive under the Roots agreement?
When is the OCGN special meeting, and what is the new record date?
Who controls OCU400 regulatory submissions in the OCGN license territory?
How long does the OCGN-Roots OCU400 license last?
When does OCGN expect OCU400 Phase 3 topline data?
AI-generated analysis. How Rhea-AI works. Not financial advice.
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, DC 20549
FORM
CURRENT REPORT
Pursuant to Section 13 OR 15(d)
of the Securities Exchange Act of 1934
Date of Report (Date of Earliest Event Reported):
(Exact Name of Registrant as Specified in its Charter)
| (State or Other Jurisdiction of Incorporation) |
(Commission File Number) |
(IRS Employer Identification No.) |
(Address of principal executive offices) (Zip Code)
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 | ||
|
The (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 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 | ||
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