Ocugen第二季虧損擴大惟現金增至1億美元，失明基因療法臨床進展成焦點

EX-99.1
2
tm2622368d1_ex99-1.htm
EXHIBIT 99.1

 

 

Exhibit 99.1

 

 

 

Ocugen Provides Business Update with Second
Quarter 2026 Financial Results

 

Conference Call and Webcast Today at 8:30 a.m. ET

 

·Received
 U.S. Food and Drug Administration (FDA) clearance to initiate OCU410 Phase 3 trial for geographic
 atrophy (GA), secondary to dry age-related macular degeneration (AMD); on track to initiate
 Phase 3 this quarter

 

·Granted
 Regenerative Medicine Advanced Therapy (RMAT) designation by FDA for OCU410, enabling eligibility
 for priority review and accelerated approval

 

·Signed
 a binding term sheet with Roots Pharmaceutical, and its strategic partner Al-Dhow International
 Holding, to negotiate an exclusive license for OCU400 in retinitis pigmentosa (RP) across
 the Middle East and North Africa (MENA) region

 

·Successfully
 completed OCU400 Process Performance Qualification (PPQ) batches, supporting Biologics License
 Application (BLA) and commercial launch supplies

 

·Closed
 $130.0 million convertible senior notes financing, extending cash runway into 2028

 

·Remain
 on track to announce top-line results for two late-stage clinical programs, OCU400 for RP
 and OCU410ST for Stargardt disease in 1Q 2027 and 2Q 2027, respectively

 

·Strengthened
 leadership team with the appointments of Mohamed Genead, M.D., M.Sc., as Chief Medical Officer
 and Chris Clark as Head of Corporate Communications

 

MALVERN, Pa., August 6, 2026 (GLOBE NEWSWIRE) -- Ocugen, Inc.
(“Ocugen” or the “Company”) (NASDAQ: OCGN), a pioneering biotechnology leader in gene therapies for blindness
diseases, today reported second quarter 2026 financial results along with a general business update.

 

“The second quarter of 2026 marked a pivotal inflection point
for Ocugen. We closed $130 million convertible senior notes financing, extending our cash runway into 2028, and signed a binding term
sheet for exclusive license of OCU400 in retinitis pigmentosa across the Middle East and North Africa region,” said Dr. Shankar
Musunuri, Chairman, Chief Executive Officer, and Co-Founder of Ocugen. “Ocugen is a leading gene therapy company, focused on vision
loss diseases with significant unmet medical needs, with multiple catalysts through 2028 across three distinct retinal disease indications.
As we advance toward key data milestones in the first half of 2027, we remain focused on creating long-term value for our patients and
shareholders.”

 

Unlike traditional gene therapies that correct a single mutation,
Ocugen's modifier gene therapy platform targets master regulatory genes that control multiple gene networks of biological pathways, supporting
a gene-agnostic approach applicable across a broad range of genetic mutations, as well as diseases with complex pathways such as dry
AMD. This allows the Company to address large, underserved patient populations rather than narrow single-gene subsets. This platform
underpins each of Ocugen's three late-stage programs, which advanced meaningfully during the quarter.

 

  

  

 

 

 

 

Clinical Program Updates

 

OCU410 (GA)

 

·Received
 FDA clearance for the Phase 3 registrational trial (ArMaDa3) for GA secondary to dry age-related
 macular degeneration, anchored by positive 12-month Phase 2 ArMaDa data (statistically significant
 31% reduction in GA lesion growth versus control [patient population: lesion size ≥2.5
 mm2 and ≤17.5 mm2], p<0.05, at the optimal dose planned for Phase
 3)

 

·Planned
 combined global Phase 3 trial of approximately 237 subjects powered at 95% for primary end
 point on track to initiate this quarter, with BLA and MAA filings targeted for 2028

 

·Granted
 Regenerative Medicine Advanced Therapy RMAT designation by FDA, enabling eligibility for
 priority review and accelerated approval

 

·GA
 affects approximately 2 to 3 million people in the U.S. and Europe

 

OCU410ST (Stargardt disease)

 

·Completed
 enrollment and dosing of 63 subjects ahead of schedule, in less than nine months, in the
 pivotal Phase 2/3 GARDian3 trial evaluating OCU410ST in patients with all mutations of Stargardt
 disease

 

·Topline
 results anticipated in the second quarter of 2027, with a BLA submission to follow mid-2027

 

·Holds
 Orphan Drug and Rare Pediatric Disease Designations from the FDA and Orphan Medicinal Product
 Designation and Advanced Therapy Medicinal Product classification from the EMA

 

·Stargardt
 disease affects approximately 100,000 patients across the U.S. and Europe, with no approved
 therapies globally

 

OCU400 (RP)

 

·Completed
 enrollment in liMeliGhT (N=140), the first and largest genetic medicine registrational trial
 for broad RP patients, spanning more than 30 genetic mutations

 

·FDA
 feedback confirmed that the path to rolling BLA submission remains tied to topline data expected
 in the first quarter of 2027, and the company is advancing preparation accordingly, including
 successfully completing Process Performance Qualification (PPQ) batches

 

·Approximately
 300,000 people in the U.S. and Europe are living with RP

 

Corporate Updates

 

·Closed
 the offering of $130.0 million aggregate principal amount of 6.75% Convertible Senior Notes
 due 2034, including the full exercise of the $15.0 million over-allotment option, for net
 proceeds of approximately $112.5 million

 

oApproximately $32.7 million of net proceeds was used to fully retire
 the Avenue Capital loan, eliminating 12.25% interest-rate debt from the Company’s capital
 structure

 

oThe offering extends Ocugen’s cash runway into 2028

 

·Signed
 a binding term sheet with Roots Pharmaceutical to negotiate an exclusive OCU400 license in
 the MENA region, with up to $255 million in sales milestones and a 22% royalty on net sales,
 as well as moderate upfront payment to Ocugen

 

·Ocugen
 appointed two new members to its leadership team

 

oMohamed Genead, M.D., M.Sc., was named Chief Medical Officer on June 11,
 2026. Dr. Genead is an ophthalmologist and retina specialist with more than 20 years
 of experience in ophthalmology and gene therapy, having previously served as Co-Founder and
 Chief Executive Officer of Aviceda Therapeutics and in senior leadership roles at GenSight
 Biologics, Biogen, and Allergan

 

oChris Clark was named Vice President, Corporate Communications on
 July 16, 2026. He has more than 20 years of communications and investor relations experience
 in the pharmaceutical and biopharmaceutical industries, having held leadership positions
 at Bausch + Lomb, Idorsia Pharmaceuticals, and Pfizer, as well as communications and
 investor relations roles at Novo Nordisk, Bristol Myers Squibb, Endo Pharmaceuticals, and
 Johnson & Johnson

 

  

  

 

 

 

 

Second Quarter 2026 Financial Results

 

·The
 Company’s cash, cash equivalents, and restricted cash totaled $100.4 million as of
 June 30, 2026, compared to $32.2 million as of March 31, 2026.

 

·The
 Company had 339.0 million shares of common stock outstanding as of June 30, 2026.

 

·Total
 operating expenses for the three months ended June 30, 2026, were $17.9 million and
 included research and development expenses of $10.7 million and general and administrative
 expenses of $7.2 million, compared to total operating expenses for the three months ended
 June 30, 2025, of $15.2 million that included research and development expenses of $8.4
 million and general and administrative expenses of $6.8 million.

 

·Ocugen
 reported a $0.07 net loss per common share for the three months ended June 30, 2026,
 compared to a $0.05 net loss per common share for the three months ended June 30, 2025.

 

Conference Call and Webcast Details

 

Ocugen has scheduled a conference call and webcast for 8:30 a.m. ET
today to discuss the financial results and recent business highlights. Ocugen’s senior management team will host the call, which
will be open to all listeners. There will also be a question-and-answer session following the prepared remarks.

 

Attendees are invited to participate on the call using the following
details:

 

Dial-in Numbers: (800) 715-9871 for U.S. callers and (646)
307-1963 for international callers
Conference ID: 2222566
Webcast: Available on the events section of the Ocugen investor site

 

A replay of the call and archived webcast will be available on the
Ocugen investor site.

 

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 us on LinkedIn and
X.

 

  

  

 

 

 

 

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, strategy, 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 enrollment and data readouts, the ability to initiate new
clinical programs, Ocugen’s financial condition and expected cash runway into 2028, 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. 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 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 our annual and 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.

 

Contacts:

 

Investors:
Candice Masse
astr partners
[email protected]

 

Media:
Chris Clark
[email protected]

 

(Tables to follow)

 

  

  

 

 

 

 

OCUGEN, INC.

CONDENSED CONSOLIDATED BALANCE SHEETS

(in thousands, except share and per share amounts)

(Unaudited)

 

 
  
  
 June 30, 2026
  
  
 Dec 31, 2025
  

 
 Assets
  
  
  
  
  
  
  
  

 
 Current assets
  
  
  
  
  
  
  
  

 
 Cash
  
 $
 100,051
  
  
 $
 18,571
  

 
 Prepaid expenses and other current assets
  
  
 6,670
  
  
  
 5,769
  

 
 Total current assets
  
  
 106,721
  
  
  
 24,340
  

 
 Property and equipment, net
  
  
 13,347
  
  
  
 14,392
  

 
 Restricted cash
  
  
 320
  
  
  
 316
  

 
 Other assets
  
  
 3,818
  
  
  
 4,468
  

 
 Total assets
  
 $
 124,206
  
  
 $
 43,516
  

 
 Liabilities and stockholders' equity
  
  
  
  
  
  
  
  

 
 Current liabilities
  
  
  
  
  
  
  
  

 
 Accounts payable
  
 $
 5,140
  
  
 $
 6,202
  

 
 Accrued expenses and other current liabilities
  
  
 11,014
  
  
  
 14,733
  

 
 Operating lease obligations
  
  
 839
  
  
  
 858
  

 
 Convertible notes
  
  
 82,359
  
  
  
 -
  

 
 Derivative liability
  
  
 33,708
  
  
  
 -
  

 
 Current portion of long-term debt
  
  
 20
  
  
  
 1,250
  

 
 Total current liabilities
  
  
 133,080
  
  
  
 23,043
  

 
 Non-current liabilities
  
  
  
  
  
  
  
  

 
 Operating lease obligations, less current portion
  
  
 3,039
  
  
  
 3,494
  

 
 Long term debt, net
  
  
 1,729
  
  
  
 27,542
  

 
 Other non-current liabilities
  
  
 2,914
  
  
  
 1,603
  

 
 Total non-current liabilities
  
  
 7,682
  
  
  
 32,639
  

 
 Total liabilities
  
 $
 140,762
  
  
 $
 55,682
  

 
  
  
  
  
  
  
  
  
  

 
 Stockholders' equity
  
  
  
  
  
  
  
  

 
 Common stock
  
  
 3,390
  
  
  
 3,125
  

 
 Treasury stock
  
  
 (48
 )
  
  
 (48
 )

 
 Additional paid-in capital
  
  
 432,010
  
  
  
 392,763
  

 
 Accumulated other comprehensive income
  
  
 213
  
  
  
 61
  

 
 Accumulated deficit
  
  
 (452,121
 )
  
  
 (408,067
 )

 
 Total stockholders' equity
  
  
 (16,556
 )
  
  
 (12,166
 )

 
 Total liabilities and stockholders' equity
  
 $
 124,206
  
  
 $
 43,516
  

 

 

  

  

 

 

 

 

OCUGEN, INC.

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
AND COMPREHENSIVE LOSS

(in thousands, except share and per share amounts)

(Unaudited)

 

 
   
 Three months ended June 30,  
 Six months ended
 June 30,
 

 
   
 2026  
 2025  
 2026  
 2025 

 
 Collaborative arrangement revenue 
 $1,488  
 $1,373  
 $3,022  
 $2,854 

 
 Total revenue 
  1,488  
  1,373  
  3,022  
  2,854 

 
 Operating expenses 
     
     
     
    

 
 Research and development 
  10,690  
  8,402  
  21,945  
  17,932 

 
 General and administrative 
  7,242  
  6,766  
  15,359  
  13,218 

 
 Total operating expenses 
 $17,932  
 $15,168  
 $37,304  
 $31,150 

 
 Loss from operations 
  (16,444) 
  (13,795) 
  (34,282) 
  (28,296)

 
 Interest income 
  395  
  227  
  526  
  571 

 
 Interest expense 
  (4,476) 
  (1,285) 
  (5,796) 
  (2,543)

 
 Loss on extinguishment of debt 
  (2,383) 
  -  
  (2,383) 
  - 

 
 Change in fair value of derivative liability 
  (1,891) 
  -  
  (1,891) 
  - 

 
 Other (expense) income, net 
  (78) 
  114  
  (228) 
  179 

 
 Total other (expense) income 
 $(8,433) 
 $(944) 
 $(9,772) 
 $(1,793)

 
 Net loss 
 $(24,877) 
 $(14,739) 
 $(44,054) 
 $(30,089)

 
 Other comprehensive income (loss) 
     
     
     
    

 
 Foreign currency translation adjustment 
  49  
  (28) 
  152  
  (36)

 
 Comprehensive loss 
 $(24,828) 
 $(14,767) 
 $(43,902) 
 $(30,125)

 
   
     
     
     
    

 
 Net loss attributable to common shareholders — basic and diluted 
  (24,877) 
  (14,739) 
  (44,054) 
  (30,089)

 
 Weighted shares used in calculating net loss per common share — basic and diluted 
  338,679,856  
  292,067,192  
  333,142,618  
  292,032,072 

 
 Net loss per share attributable to common shareholders — basic and diluted 
 $(0.07) 
 $(0.05) 
 $(0.13) 
 $(0.10)