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重大事件 即時報告 8-K 2026-07-13

Ocugen與Roots Pharmaceutical簽訂OCU400中東北非獨家授權協議,最高可獲2.55億美元里程碑金

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Ocugen, Inc.(納斯達克:OCGN)於2026年7月13日提交8-K表格,披露已與Roots Pharmaceutical及其策略夥伴Al-Dhow International Holding簽訂具有約束力的條款清單,授予OCU400(修飾基因療法)在中東及北非(MENA)地區治療視網膜色素變性(RP)的獨家授權。 根據條款清單,Ocugen預計可收取前期授權費及近期開發里程碑付款合共最多400萬美元,以及累計銷售里程碑付款高達2.55億美元,另加基於淨銷售額22%的特許權使用費。Ocugen將負責OCU400的商業化生產及供應。雙方預計在90天內簽署最終協議。 RP是遺傳性視力損失的主因,在MENA地區尤其普遍,存在巨大未滿足醫療需求。Ocugen行政總裁Dr. Shankar Musunuri表示,此合作是OCU400區域策略的重要里程碑,能為當地急需治療的患者帶來一次性潛在治療方案。Roots Pharmaceutical行政總裁Dr. Islam Zayed強調,引進創新基因療法符合其使命,有望減輕疾病負擔。 Ocugen正推進OCU400的第三期liMeliGhT臨床試驗,預計2027年第一季公佈頂線數據,隨後提交生物製劑許可申請(BLA)。此協議為Ocugen開拓新市場及潛在收入來源,但投資者需留意最終協議可能延遲或無法簽署,以及臨床試驗結果存在不確定性。
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EX-99.1
2
tm2620295d1_ex99-1.htm
EXHIBIT 99.1

 

Exhibit 99.1

 

 

 

Ocugen, Inc. Announces Binding Term Sheet with Roots
Pharmaceutical to License OCU400 Modifier Gene Therapy for Retinitis Pigmentosa in the Middle East and North Africa

 

·Cumulative sales milestones up to $255 million and modest upfront/near-term development milestones

 

·Royalties equaling 22% of net sales

 

·Ocugen to manufacture and supply OCU400

 

MALVERN, Pa., July 13, 2026 (GLOBE NEWSWIRE) -- Ocugen,
Inc. (“Ocugen” or the “Company”) (NASDAQ: OCGN), a pioneering biotechnology leader in gene therapies for blindness
diseases, today announced the signing of a binding term sheet to negotiate and enter into a license 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
Retinitis Pigmentosa (RP), in the Middle East and North Africa (MENA) region.

 

Pursuant to the term sheet, under the license agreement,
Ocugen is expected to receive upfront license fees and near-term development milestone payments totaling up to $4 million. The Company
would be entitled to sales milestone payments up to $255 million, in addition to a 22% royalty on net sales of OCU400 generated by Ocugen's
partner. Additionally, Ocugen would manufacture commercial supply of OCU400 under the terms of a related supply agreement.

RP is a leading cause of inherited vision loss globally,
with notable prevalence across the MENA region, underscoring the significant unmet need OCU400 is positioned to address through this partnership.

 

"This step forward represents an important milestone
in our effort to advance OCU400 regional partnership strategy," said Dr. Shankar Musunuri, Chairman, CEO, and Co-founder of Ocugen.
 "By partnering with an established leader with strong reach across the Middle East and North Africa, we are expanding our ability
to bring this one-time potential treatment for life to a region where RP is highly prevalent with a significant unmet medical
need where patients are desperately looking for rescue from blindness. This agreement underscores the momentum behind OCU400 and our continued
commitment to patients."   

“Bringing innovative gene therapies to patients
across the MENA region is a strategic imperative for Roots Pharmaceutical and its strategic partner Al-Dhow International Holding,”
said Dr. Islam Zayed, CEO & Co founder of Roots Pharmaceutical. Dr. Zayed emphasized that “ OCU400 built on our legacy of bringing
Rare Disease therapies to patients in MENA and enables our combined teams to decrease disease burden in the region. Importantly, Roots
is dedicated to bringing OCU400 to patients with Retinitis Pigmentosa and creating a new treatment paradigm. We are excited to partner
with the Ocugen team.”

Additional details will be available once the definitive
agreement between the parties is executed, which is expected to occur within the next 90 days.

Ocugen continues to advance OCU400 through its Phase
3 liMeliGhT clinical development with a topline readout expected in 1Q 2027 and BLA submission to follow.

 

About Ocugen, Inc.

Ocugen, Inc. is a pioneering biotechnology leader in gene
therapies for blindness diseases. Our breakthrough modifier gene therapy platform has the potential to address significant unmet medical
need for large patient populations through our gene-agnostic approach. Unlike traditional gene therapies and gene editing, Ocugen’s
modifier gene therapies address the entire disease—complex diseases that are potentially caused by imbalances in multiple gene
networks. Currently we have programs in development for inherited retinal diseases and blindness diseases affecting millions across the
globe, including retinitis pigmentosa, Stargardt disease, and geographic atrophy—late-stage dry age-related macular degeneration.
Discover more at www.ocugen.com and follow us on X and LinkedIn.

 

  

  

 

 

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 terms of the definitive license and supply agreement with Roots Pharmaceutical, the timing of entering into such definitive agreement
or whether such definitive agreement will be executed at all, the anticipated benefits to Ocugen of such definitive agreement, qualitative
assessments of available data, potential benefits, expectations for ongoing clinical trials, anticipated regulatory filings and anticipated
development timelines, which are subject to risks and uncertainties. We 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 our current expectations, including, but not limited to, the risks that the definitive license and supply agreement with
Roots Pharmaceutical will be delayed or not executed at all, or that, if executed, it will not be on terms described above, the risk that
such definitive agreement, if executed, will not lead to the currently anticipated benefits to Ocugen, the risks 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 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 our periodic 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 we file with the SEC. Any forward-looking
statements that we make in this press release speak only as of the date of this press release. Except as required by law, we assume 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.

 

Investor Contact:
Candice Masse
astr partners
[email protected]