Conference Call and Webcast Today at 8:30 a.m. ET
Ocugen, Inc. ("Ocugen") (NASDAQ: OCGN), a biopharmaceutical company focused on discovering, developing, and commercializing gene therapies to cure blindness diseases and developing a vaccine to save lives from COVID-19, today reported full year 2020 financial results along with a general business update.
"We made strong progress toward our goal of offering a differentiated vaccine to save lives from COVID-19 and in our work toward curing blindness diseases. We are actively working with U.S. regulatory authorities to develop a plan around Emergency Use Authorization in the United States for COVAXIN(TM) and are preparing to file an Investigational New Drug application to initiate our first two clinical trials for OCU400 in the second half of this year. Proceeds from our recent registered direct offering provide the financial resources to drive our COVAXIN(TM) development efforts and ophthalmology pipeline forward," said Dr. Shankar Musunuri, Chairman, Chief Executive Officer, and Co-Founder of Ocugen.
Full Year 2020 Financial Results:
Conference Call and Webcast Details
Ocugen has scheduled a conference call and webcast for 8:30 a.m. eastern time 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.
The call can be accessed by dialing (844) 873-7330 (U.S.) or (602) 563-8473 (international) and providing the conference ID 2375087. 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 gene therapies to cure blindness diseases and developing a vaccine to save lives from COVID-19. 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. We are co-developing Bharat Biotech's COVAXIN(TM) vaccine candidate for COVID-19 in the U.S. market. 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 forward-looking statements include information about qualitative assessments of available data, potential benefits, expectations for clinical trials, and anticipated timing of clinical trial readouts and regulatory submissions. This information involves risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, among other things, the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, as well as risks associated with preliminary and interim data (including the Phase 3 interim data related to COVAXIN(TM)), including the possibility of unfavorable new clinical trial data and further analyses of existing clinical trial data; the risk that clinical trial data are subject to differing interpretations and assessments, including during the peer review/publication process, in the scientific community generally, and by regulatory authorities; whether and when data from Bharat Biotech's clinical trials will be published in scientific journal publications and, if so, when and with what modifications; whether the U.S. Food and Drug Administration ("FDA") will be satisfied with the design of and results from preclinical and clinical studies of COVAXIN(TM), which have been conducted by Bharat Biotech in India; whether and when any biologics license and/or EUA applications may be filed in the United States for COVAXIN(TM); whether and when any such applications may be approved by the FDA; decisions by the FDA impacting labeling, manufacturing processes, safety and/or other matters that could affect the availability or commercial potential of COVAXIN(TM) in the United States, including development of products or therapies by other companies. 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.
This press release contains a preliminary estimate of Ocugen's cash, cash equivalents, and restricted cash as of February 28, 2021. The preliminary estimate should not be viewed as a substitute for interim financial statements prepared in accordance with U.S. generally accepted accounting principles. The preliminary estimate is based on preliminary unaudited information and management estimates as of February 28, 2021, is not a comprehensive statement of Ocugen's financial results, and is subject to the completion of Ocugen's financial closing procedures. As a result, this preliminary estimate may differ from the actual results that will be reflected in Ocugen's financial statements when they are completed and publicly disclosed. Additional information and disclosures would be required for a more complete understanding of Ocugen's financial position as of February 28, 2021. Ocugen's independent registered public accounting firm has not conducted an audit or review of, and does not express an opinion or any other form of assurance with respect to, the preliminary estimate.
Chief Financial Officer and Head of Corporate Development
(tables to follow)
CONSOLIDATED BALANCE SHEETS
December 31, December 31, 2020 2019 Assets Current assets Cash and cash equivalents $ 24,039,325 $ 7,444,052 Prepaid expenses and other current assets 1,838,357 1,322,167 Asset held for sale -- 7,000,000 Total current assets 25,877,682 15,766,219 Property and equipment, net 632,967 222,464 Restricted cash 151,226 151,016 Other assets 714,477 667,747 Total assets $ 27,376,352 $ 16,807,446 Liabilities and stockholders' equity Current liabilities Accounts payable $ 395,034 $ 1,895,613 Accrued expenses 2,930,395 2,270,045 Short-term debt, net 234,119 -- Operating lease obligation 44,248 172,310 Other current liabilities 9,755 205,991 Total current liabilities 3,613,551 4,543,959 Non-current liabilities Operating lease obligation, less current portion 389,317 163,198 Long term debt, net 1,823,043 1,072,123 Other non-current liabilities -- 9,755 Total liabilities 5,825,911 5,789,035 Stockholders' equity Common stock 1,841,334 527,467 Treasury Stock (47,864 ) (47,864 ) Additional paid-in capital 93,058,748 62,018,632 Accumulated deficit (73,301,777 ) (51,479,824 ) Total stockholders' equity 21,550,441 11,018,411 Total liabilities and stockholders' equity $ 27,376,352 $ 16,807,446
CONSOLIDATED STATEMENTS OF OPERATIONS
Year ended December 31, 2020 2019 Revenues Collaboration revenue $ 42,620 $ -- Total revenues 42,620 -- Operating expenses Research and development 6,353,287 8,085,522 In-process research and development 7,000,000 -- General and administrative 7,974,050 6,077,097 Total operating expenses 21,327,337 14,162,619 Loss from operations (21,284,717 ) (14,162,619 ) Other income (expense) Change in fair value of derivative liabilities -- (3,187,380 ) Loss on debt conversion -- (341,136 ) Interest income 1,065 1,214 Interest expense (720,963 ) (1,767,836 ) Other income (expense) 182,662 (784,873 ) Total other income (expense) (537,236 ) (6,080,011 ) Net loss $ (21,821,953 ) $ (20,242,630 ) Deemed dividend related to Warrant Exchange (12,546,340 ) -- Net loss to common stockholders $ (34,368,293 ) $ (20,242,630 ) Shares used in calculating net loss per common share -- basic and diluted 112,236,110 13,893,819 Net loss per share of common stock -- basic and diluted $ (0.31 ) $ (1.46 )