MALVERN, Pa., Feb. 28, 2023 (GLOBE NEWSWIRE) -- Ocugen, Inc. (Ocugen or the Company) (NASDAQ: OCGN), a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies, biologics, and vaccines, today reported fourth quarter and full year 2022 financial results along with a general business update.
“We continue to grow and advance as a diversified biotechnology organization as reflected in our accomplishments of 2022,” said Dr. Shankar Musunuri, Chairman, Chief Executive Officer, and Co-Founder of Ocugen. “Our pipeline has been expanded to appropriately address the current challenges and gaps in the fight against COVID-19, application of OCU410 to address Stargardt (a rare eye disease), and our novel approach to address dry age-related macular degeneration (dAMD)—a disease affecting vision in over 266 million people worldwide.
“Following FDA concurrence in the fourth quarter of 2022 on a confirmatory Phase 3 clinical trial design for NeoCart®, we are developing internal capabilities to move our regenerative medicine asset, NeoCart®, into the clinic next year.”
“The FDA has granted expanded orphan drug designations to OCU400 for the treatment of retinitis pigmentosa (RP) and Leber congenital amaurosis (LCA),” said Dr. Musunuri. “These broad, gene-agnostic designations are encouraging at this stage in the development of OCU400.”
“During our first decade, we have built a strong foundation for addressing the diseases and conditions we aim to treat. We delivered on our promise to file an OCU200 IND in the first quarter of 2023 and look forward to delivering on important milestones in 2023, especially regarding preliminary efficacy data for gene therapy product OCU400, as we progress toward realizing our long-term vision to address unmet medical needs through courageous innovation,” Dr. Musunuri concluded.
Business Updates
Ophthalmic Gene Therapies
Ophthalmic Biologic Product
Regenerative Cell Therapies
Vaccines Portfolio
Financial Results
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 or webcast using the following details:
Dial-in Numbers: (800) 715-9871 for U.S. callers and (646) 307-1963 for international callers
Conference ID: 8912239
Webcast: Available on Ocugen’s investor site
A replay of the call and archived webcast will be available for approximately 45 days following the event on the Ocugen investor site.
About Ocugen, Inc.
Ocugen, Inc. is a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies, biologics, and vaccines that improve health and offer hope for patients across the globe. We are making an impact on patient’s lives through courageous innovation—forging new scientific paths that harness our unique intellectual and human capital. Our breakthrough modifier gene therapy platform has the potential to treat multiple retinal diseases with a single product, and we are advancing research in infectious diseases to support public health and orthopedic diseases to address unmet medical needs.
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 (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.
Contact:
Tiffany Hamilton
Head of Communications
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OCUGEN, INC.
CONSOLIDATED BALANCE SHEETS
(in thousands)
(Unaudited)
| As of December 31, | ||||||||
| 2022 | 2021 | |||||||
| Assets | ||||||||
| Current assets | ||||||||
| Cash and cash equivalents | $ | 77,563 | $ | 94,958 | ||||
| Marketable securities | 13,371 | — | ||||||
| Prepaid expenses and other current assets | 7,558 | 7,688 | ||||||
| Total current assets | 98,492 | 102,646 | ||||||
| Property and equipment, net | 6,053 | 1,164 | ||||||
| Restricted cash | — | 151 | ||||||
| Other assets | 4,087 | 1,800 | ||||||
| Total assets | $ | 108,632 | $ | 105,761 | ||||
| Liabilities and stockholders' equity | ||||||||
| Current liabilities | ||||||||
| Accounts payable | $ | 8,062 | $ | 2,312 | ||||
| Accrued expenses and other current liabilities | 9,900 | 4,325 | ||||||
| Operating lease obligations | 498 | 363 | ||||||
| Total current liabilities | 18,460 | 7,000 | ||||||
| Non-current liabilities | ||||||||
| Operating lease obligations, less current portion | 3,587 | 1,231 | ||||||
| Long term debt, net | 2,289 | 1,712 | ||||||
| Other non-current liabilities | 244 | — | ||||||
| Total liabilities | 24,580 | 9,943 | ||||||
| Stockholders' equity | ||||||||
| Convertible preferred stock | 1 | 1 | ||||||
| Common stock | 2,217 | 1,995 | ||||||
| Treasury stock | (48 | ) | (48 | ) | ||||
| Additional paid-in capital | 294,874 | 225,537 | ||||||
| Accumulated other comprehensive income | 26 | — | ||||||
| Accumulated deficit | (213,018 | ) | (131,667 | ) | ||||
| Total stockholders' equity | 84,052 | 95,818 | ||||||
| Total liabilities and stockholders' equity | $ | 108,632 | $ | 105,761 | ||||
OCUGEN, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except share and per share amounts)
(Unaudited)
| Three months ended December 31, | Year ended December 31, | |||||||||||||||||
| 2022 | 2021 | 2022 | 2021 | |||||||||||||||
| Operating expenses | ||||||||||||||||||
| Research and development | $ | 17,213 | $ | 7,102 | $ | 49,757 | $ | 35,108 | ||||||||||
| General and administrative | 6,937 | 7,470 | 35,111 | 22,920 | ||||||||||||||
| Total operating expenses | 24,150 | 14,572 | 84,868 | 58,028 | ||||||||||||||
| Loss from operations | (24,150 | ) | (14,572 | ) | (84,868 | ) | (58,028 | ) | ||||||||||
| Other income (expense), net | 2,211 | (9 | ) | 3,517 | (389 | ) | ||||||||||||
| Loss before income taxes | (21,939 | ) | (14,581 | ) | (81,351 | ) | (58,417 | ) | ||||||||||
| Income tax benefit | — | — | — | (52 | ) | |||||||||||||
| Net loss | $ | (21,939 | ) | $ | (14,581 | ) | $ | (81,351 | ) | $ | (58,365 | ) | ||||||
| Shares used in calculating net loss per common share — basic and diluted | 220,072,823 | 199,207,502 | 214,600,051 | 195,013,043 | ||||||||||||||
| Net loss per common share — basic and diluted | $ | (0.10 | ) | $ | (0.07 | ) | $ | (0.38 | ) | $ | (0.30 | ) | ||||||
| Last Trade: | US$0.74 |
| Daily Change: | -0.0051 -0.69 |
| Daily Volume: | 4,193,197 |
| Market Cap: | US$214.120M |
December 11, 2024 November 27, 2024 | |
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