Two Additional Orphan Drug Designations Granted for OCU400 Modifier Gene Therapy Program

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

MALVERN, Pa., Aug. 14, 2020 (GLOBE NEWSWIRE) -- Ocugen, Inc. (NASDAQ: OCGN), a biopharmaceutical company focused on discovering, developing and commercializing transformative therapies to cure blindness diseases, today reported second quarter 2020 financial results along with a general business update.

“I am very proud of the progress we have made this quarter as we work to develop transformative therapies with the potential to cure blindness diseases. Despite the challenges of the global pandemic, we remain on track to enter the clinic next year with our first gene therapy product candidate, OCU400, for retinitis pigmentosa. Our second gene therapy product, OCU410, for dry age-related macular degeneration and our first novel biologic, OCU200, for major retinal diseases are on track to enter the clinic in 2022,” said Dr. Shankar Musunuri, Chairman, Chief Executive Officer and Co-Founder of Ocugen.

Business Highlights:

  • Four Orphan Drug Designations (“ODD”) for OCU400 – In late July 2020, the United States Food and Drug Administration (“FDA”) granted the third ODD for OCU400 for the treatment of rhodopsin (“RHO”) mutation-associated retinal degeneration. The RHO mutation is one of the more common mutations that cause retinitis pigmentosa (“RP”), a group of rare genetic disorders, with the RHO mutation representing about 12% of RP patients in the United States. In early August 2020, the FDA granted another ODD for OCU400 for the treatment of phosphodiesterase 6B (“PDE6B”) mutation-associated RP.

  • World Orphan Drug Congress USA 2020 Conference – On August 24, 2020, Dr. Rasappa Arumugham, Chief Scientific Officer of Ocugen, will highlight Ocugen’s breakthrough modifier gene therapy platform as part of the Next Generation Therapies Seminar.

  • Chair Appointment for the Retina Scientific Advisory Board – In June 2020, Ocugen announced the appointment of Dr. Mohamed Genead as chair of the Ocugen, Inc. Retina Scientific Advisory Board, which is comprised of prominent experts who provide strategic advice, clinical and regulatory support, and scientific and industry expertise. The Company believes Dr. Genead’s deep experience in ophthalmology and gene therapy will be instrumental as it advances its breakthrough modifier gene therapy platform into the clinic next year.

  • Discontinuance of OCU300 for ocular Graft vs. Host Disease and Reduction in Force – In June 2020, after review of a pre-planned interim sample size analysis which indicated the trial was unlikely to meet its co-primary endpoints upon completion, Ocugen discontinued the Phase 3 trial and initiated a workforce reduction as part of this shift in focus towards its gene therapy platform and novel biologics program aimed at curing blindness diseases. Ocugen expects the workforce reduction will result in approximately $2.0 million in annualized cost savings commencing in 2021.

  • Extension of Cash Runway – Ocugen sold an aggregate of 59.1 million shares of common stock in separate at-the-market offerings (“ATMs”) commenced in May 2020 and June 2020, generating net proceeds of $15.4 million and increasing its cash runway into the first quarter of 2021.

Second Quarter 2020 Financial Results:

  • In April 2020, Ocugen completed an amendment and exchange of its Series A Warrants for an aggregate of 21.9 million shares of Ocugen’s common stock and non-interest-bearing unsecured notes in the aggregate principal amount of $5.6 million. The Company has made prepayments of $3.1 million on the unsecured notes from proceeds received under the May 2020 and June 2020 ATMs.

  • Ocugen’s cash, cash equivalents and restricted cash totaled $15.1 million as of June 30, 2020, compared to $7.6 million as of December 31, 2019. The Company had 135.0 million shares of common stock outstanding at June 30, 2020.

  • Research and development expenses for the three months ended June 30, 2020 were $1.6 million compared to $1.2 million for the three months ended June 30, 2019. General and administrative expenses for the three months ended June 30, 2020 were $1.8 million compared to $1.1 million for the three months ended June 30, 2019.

  • Ocugen reported a net loss of $3.6 million, or $0.19 loss per share, for the three months ended June 30, 2020, compared to a net loss of $3.5 million, or $0.58 loss per share, for the three months ended June 30, 2019.

Conference Call and Webcast Details

The Company has scheduled a conference call and webcast for 8:30 a.m. Eastern Time today to discuss the 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.

The call can be accessed by dialing (844) 873-7330 (U.S.) or (602) 563-8473 (international) and providing the conference ID 5587104. To access a live audio webcast of the call on the “Investors” section of the Ocugen website, please click here. A replay of the webcast will be archived on Ocugen’s website for approximately 45 days following the call.

About Ocugen, Inc.

Ocugen, Inc. is a biopharmaceutical company focused on discovering, developing, and commercializing transformative therapies to cure blindness diseases. Our breakthrough modifier gene therapy platform has the potential to treat multiple retinal diseases with one drug – “one to many” and our novel biologic product candidate aims to offer better therapy to patients with underserved diseases such as wet age-related macular degeneration, diabetic macular edema and diabetic retinopathy. For more information, please visit www.ocugen.com.

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, 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. These and other risks and uncertainties are more fully described in our periodic filings with the Securities and Exchange Commission (the “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.

Corporate Contact:
Ocugen, Inc.
Sanjay Subramanian
Chief Financial Officer
IR@Ocugen.com

Media Contact:
LaVoieHealthScience
Emmie Twombly
etwombly@lavoiehealthscience.com
+1 857-389-6042

(tables to follow)


OCUGEN, INC.
CONSOLIDATED BALANCE SHEETS
(UNAUDITED)

 June 30,
2020
 December 31,
2019
Assets   
Current assets   
Cash and cash equivalents$14,968,161   $7,444,052  
Prepaid expenses and other current assets924,500   1,322,167  
Asset held for sale7,000,000   7,000,000  
Total current assets22,892,661   15,766,219  
Property and equipment, net232,354   222,464  
Restricted cash151,157   151,016  
Other assets482,711   667,747  
Total assets$23,758,883   $16,807,446  
Liabilities and stockholders’ equity   
Current liabilities   
Accounts payable$507,864   $1,895,613  
Accrued expenses2,084,915   2,270,045  
Short-term debt, net4,068,176     
Operating lease obligation175,538   172,310  
Other current liabilities204,860   205,991  
Total current liabilities7,041,353   4,543,959  
Non-current liabilities   
Operating lease obligation, less current portion75,577   163,198  
Long term debt, net2,018,926   1,072,123  
Other non-current liabilities   9,755  
Total liabilities9,135,856   5,789,035  
Stockholders’ equity   
Common stock1,351,281   527,467  
Treasury Stock(47,864)  (47,864) 
Additional paid-in capital72,357,228   62,018,632  
Accumulated deficit(59,037,618)  (51,479,824) 
Total stockholders’ equity14,623,027   11,018,411  
Total liabilities and stockholders’ equity$23,758,883   $16,807,446  


OCUGEN, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS
(UNAUDITED)

 Three months ended June 30,  Six months ended June 30,
 2020 2019 2020 2019
Revenues       
Collaboration revenue$42,620   $   $42,620   $   
Total revenues42,620      42,620      
Operating expenses       
Research and development1,629,869   1,240,047   3,282,187   5,033,069   
General and administrative1,779,016   1,088,477   4,055,800   2,136,497   
Total operating expenses3,408,885   2,328,524   7,337,987   7,169,566   
Loss from operations(3,366,265)  (2,328,524)  (7,295,367)  (7,169,566)  
Other income (expense)       
Change in fair value of derivative liabilities   (608,149)     (1,384,422)  
Loss on debt conversion   (341,136)     (341,136)  
Interest income433   377   552   971   
Interest expense(248,143)  (261,562)  (262,892)  (957,031)  
Other income (expense)   184   (87)  (232)  
Total other income (expense)(247,710)  (1,210,286)  (262,427)  (2,681,850)  
Net loss$(3,613,975)  $(3,538,810)  $(7,557,794)  $(9,851,416)  
Deemed dividend related to Warrant Exchange(12,546,340)     (12,546,340)     
Net loss to common stockholders$(16,160,315)  $(3,538,810)  $(20,104,134)  $(9,851,416)  
        
Shares used in calculating net loss per common share — basic and diluted83,537,463   6,067,401   68,082,346   5,461,576   
Net loss per share of common stock — basic and diluted$(0.19)  $(0.58)  $(0.30)  $(1.80)