Ocugen Provides Business Update with Third Quarter 2024 Financial Results
Ocugen reported its Q3 2024 financial results and business updates. The company secured $30 million in debt financing and $35 million in equity financing, extending cash runway into Q1 2026. Their lead gene therapy program OCU400 for retinitis pigmentosa continues Phase 3 enrollment, with expansion into Canada. OCU410 is advancing in Phase 2 trials for geographic atrophy, while OCU410ST received DSMB approval for Phase 2 progression. Total operating expenses were $14.4 million for Q3 2024, compared to $16.1 million in Q3 2023. Cash position stood at $39.0 million as of September 30, 2024.
Ocugen ha riportato i risultati finanziari e degli aggiornamenti aziendali per il terzo trimestre del 2024. L'azienda ha ottenuto 30 milioni di dollari in finanziamenti mediante debito e 35 milioni di dollari in finanziamenti patrimoniali, estendendo la liquidità fino al primo trimestre del 2026. Il loro principale programma di terapia genica OCU400 per la retinite pigmentosa continua l'arruolamento nella fase 3, con un'espansione in Canada. OCU410 avanza nella fase 2 per l'atrofia geografica, mentre OCU410ST ha ricevuto l'approvazione del DSMB per la progressione alla fase 2. Le spese operative totali sono state di 14,4 milioni di dollari per il terzo trimestre del 2024, rispetto a 16,1 milioni di dollari nel terzo trimestre del 2023. La posizione di cassa era di 39,0 milioni di dollari al 30 settembre 2024.
Ocugen reportó sus resultados financieros y actualizaciones empresariales del tercer trimestre de 2024. La compañía aseguró 30 millones de dólares en financiamiento de deuda y 35 millones de dólares en financiamiento de capital, extendiendo su liquidez hasta el primer trimestre de 2026. Su principal programa de terapia génica OCU400 para la retinosis pigmentaria continúa con el reclutamiento en la fase 3, con una expansión hacia Canadá. OCU410 avanza en ensayos de fase 2 para la atrofia geográfica, mientras que OCU410ST recibió la aprobación del DSMB para progresar a la fase 2. Los gastos operativos totales fueron de 14,4 millones de dólares en el tercer trimestre de 2024, comparado con 16,1 millones de dólares en el tercer trimestre de 2023. La posición de efectivo era de 39,0 millones de dólares al 30 de septiembre de 2024.
Ocugen은 2024년 3분기 재무 결과 및 사업 업데이트를 보고했습니다. 이 회사는 3천만 달러의 부채 금융과 3천5백만 달러의 자본 금융을 확보하여 2026년 1분기까지 자금을 연장했습니다. 그들의 주요 유전자 치료 프로그램 OCU400은 색소 망막염에 대한 3단계 등록을 계속하고 있으며, 캐나다로 확장되고 있습니다. OCU410은 지리적 위축을 위한 2단계 시험에서 발전 중이며, OCU410ST는 2단계 진행에 대한 DSMB 승인을 받았습니다. 2024년 3분기 총 운영 비용은 1천4백40만 달러로, 2023년 3분기의 1천6백10만 달러에 비해 감소했습니다. 2024년 9월 30일 기준 현금 잔고는 3천9백만 달러였습니다.
Ocugen a publié ses résultats financiers et mises à jour commerciales pour le troisième trimestre 2024. L'entreprise a sécurisé 30 millions de dollars en financement par dette et 35 millions de dollars en financement par actions, prolongeant sa liquidité jusqu'au premier trimestre 2026. Leur programme phare de thérapie génique OCU400 pour la rétinite pigmentaire continue son inscription en phase 3, avec une expansion vers le Canada. OCU410 progresse dans des essais de phase 2 pour l'atrophie géographique, tandis que OCU410ST a obtenu l'approbation du DSMB pour sa progression en phase 2. Les frais d'exploitation totaux se sont élevés à 14,4 millions de dollars pour le troisième trimestre 2024, contre 16,1 millions de dollars pour le troisième trimestre 2023. La position de liquidités était de 39,0 millions de dollars au 30 septembre 2024.
Ocugen hat seine finanziellen Ergebnisse und Unternehmensupdates für das 3. Quartal 2024 bekannt gegeben. Das Unternehmen sicherte sich 30 Millionen Dollar an Schuldenfinanzierung und 35 Millionen Dollar an Eigenkapitalfinanzierung, was die Liquidität bis ins 1. Quartal 2026 verlängert. Ihr führendes Gentherapie-Programm OCU400 für die retinale Pigmentdegeneration setzt die Einschreibung in Phase 3 fort und expandiert nach Kanada. OCU410 wird in Phase 2 Trials für geografische Atrophie vorangetrieben, während OCU410ST die Genehmigung des DSMB für die Fortschritte in Phase 2 erhalten hat. Die gesamten Betriebsausgaben betrugen 14,4 Millionen Dollar im 3. Quartal 2024, verglichen mit 16,1 Millionen Dollar im 3. Quartal 2023. Die Liquiditätsposition belief sich zum 30. September 2024 auf 39,0 Millionen Dollar.
- Secured $65 million in combined debt and equity financing
- Cash runway extended into Q1 2026
- Operating expenses decreased to $14.4M from $16.1M YoY
- Expanded OCU400 Phase 3 trial into Canada, increasing market potential
- Received FDA approval for Expanded Access Program for OCU400
- Cash position decreased to $39.0M from $39.5M since December 2023
- Debt financing may increase financial obligations
Insights
The Q3 update reveals mixed financial signals. While securing
The clinical pipeline shows promising advancement across multiple programs. OCU400's Phase 3 trial expansion into Canada enhances market potential for the RP treatment, targeting a substantial patient pool of 300,000 across key markets. The Expanded Access Program approval strengthens the product's positioning. OCU410's development for geographic atrophy, affecting 2-3 million people, offers a compelling advantage with its single subretinal injection approach versus current treatments requiring 6-12 annual injections. The progression of three clinical-stage modifier gene therapies and positive DSMB reviews indicate strong execution of the development strategy.
Conference Call and Webcast Today at 8:30 a.m. ET
- Subsequent to quarter-end, closed
$30 million in debt financing - OCU400 Phase 3 liMeliGhT clinical trial for retinitis pigmentosa (RP) on track to complete enrollment in 1H2025
- OCU410 is currently in Phase 2 of the Phase 1/2 ArMaDa clinical trial
- Data and Safety Monitoring Board (DSMB) for the OCU410ST GARDian clinical trial approved enrollment for the second phase of the Phase 1/2 clinical trial
- New data on Phase 1/2 clinical trials for OCU410, OCU410ST and OCU400 to be presented at upcoming Clinical Showcase
MALVERN, Pa., Nov. 08, 2024 (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 third quarter 2024 financial results along with a general business update.
“I am very encouraged by the progress of our gene therapy programs and the clinical and regulatory milestones achieved in the third quarter of 2024, including the expansion of the OCU400 Phase 3 liMeliGhT clinical trial into Canada,” said Dr. Shankar Musunuri, Chairman, CEO, and Co-founder of Ocugen. “With the recent equity and debt financings, we have sufficient cash-on-hand to continue supporting our robust ophthalmology pipeline and extend our cash runway into 1Q2026.”
As OCU400 is advancing through Phase 3 clinical development, the expanded access program (EAP) for adult patients with early to advanced RP makes it possible to reach a greater segment of the RP patient population—300,000 in the U.S., Canada, and Europe combined. Additionally, including Canadian patients in the OCU400 Phase 3 liMeliGhT trial may allow for broader commercialization with the U.S. and Europe. These accomplishments and consistent trial enrollment are bringing the Company even closer to providing a potential one-time treatment for life to patients living with RP.
Phase 2 of the OCU410 Phase 1/2 ArMaDa clinical trial is underway and will assess the safety and efficacy of OCU410 in a larger group of patients who are randomized into either of two treatment groups (medium- or high-dose) or a control group. OCU410 is being developed for geographic atrophy (GA), an advanced stage of dry age-related macular degeneration (dAMD). GA affects approximately 2-3 million people in the U.S. & EU. Current FDA-approved treatments address only the complement system and require approximately 6-12 intravitreal injections per year, whereas OCU410 addresses all four pathways linked with dAMD pathophysiology and is delivered through a single subretinal injection. There remains no approved product to treat GA in the EU.
Over a series of conferences during the third quarter 2024, Ocugen had the opportunity to provide an update on its three clinical-stage modifier gene therapies to significant investor audiences as well as industry decision-makers during meetings like the Cell & Gene Meeting on the Mesa hosted by the Alliance for Regenerative Medicine.
“It is imperative to continue educating our key stakeholders about the differentiated mechanism of action of our gene-agnostic modifier gene therapy platform,” said Dr. Musunuri. “Unlike other product candidates in development to treat blindness diseases, our approach leverages master gene regulators that reset the functional network—rather than targeting a single mutation—and restore overall health to the retina. Our data continues to support the potential to treat multiple disease mutations with a one-time therapy for life.”
While gene therapy remains the primary focus for the Company, Ocugen continues to pursue funding opportunities across the portfolio to ensure that its innovative platforms reach the people who need them.
A clinical showcase, providing updates from Ocugen’s ongoing gene therapy trials, will be held on November 12, 2024, and will include preliminary safety and efficacy data from the Phase 1/2 OCU410 ArMaDa clinical trial for geographic atrophy and Phase 1/2 OCU410ST GARDian clinical trial for Stargardt disease, along with RP and LCA data updates from the OCU400 Phase 1/2 clinical trial.
Ophthalmic Gene Therapies—First-in-class
- OCU400 – Enrollment continues in the Phase 3 liMeliGhT clinical trial and Health Canada approved enrollment across a maximum of 5 sites in Canada. FDA approved EAP for the treatment of adult patients with RP who may benefit from the mechanism of action of OCU400.
- OCU410 – Actively recruiting patients in Phase 2 of the Phase 1/2 ArMaDa clinical trial. Preliminary safety and efficacy update on OCU410 Phase 1/2 ArMaDa clinical trial will be shared at upcoming clinical showcase.
- OCU410ST – DSMB approved proceeding to Phase 2 of the Phase 1/2 GARDian clinical trial. Preliminary safety and efficacy update will be shared at upcoming clinical showcase.
Ophthalmic Biologic Product
- OCU200 – FDA cleared the investigational new drug application for the Phase 1 clinical trial evaluating OCU200. The Company is planning to initiate the OCU200 Phase I clinical trial this quarter.
Third Quarter 2024 Financial Results
- With the recent
$30 million debt financing and$35 million equity financing in the third quarter, the cash runway now extends into 1Q2026. - The Company’s cash and restricted cash totaled
$39.0 million as of September 30, 2024, compared to$39.5 million as of December 31, 2023. - Total operating expenses for the three months ended September 30, 2024 were
$14.4 million and included research and development expenses of$8.1 million and general and administrative expenses of$6.3 million . This compares to total operating expenses for the three months ended September 30, 2023 of$16.1 million that included research and development expenses of$7.0 million and general and administrative expenses of$9.1 million .
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: 9923172
Webcast: Available on the events section of the Ocugen 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. 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, 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, expected cash runway into the first quarter of 2026, the ability to initiate new clinical programs, statements regarding 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 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 of 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 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.
Contact:
Tiffany Hamilton
Head of Communications
Tiffany.Hamilton@ocugen.com
(Tables to follow)
OCUGEN, INC. | |||||
CONSOLIDATED BALANCE SHEETS | |||||
(in thousands) | |||||
(Unaudited) | |||||
September 30, 2024 | December 31, 2023 | ||||
Assets | |||||
Current assets | |||||
Cash | $ | 38,696 | $ | 39,462 | |
Prepaid expenses and other current assets | 1,977 | 3,509 | |||
Total current assets | 40,673 | 42,971 | |||
Property and equipment, net | 17,130 | 17,290 | |||
Restricted cash | 305 | — | |||
Other assets | 3,828 | 4,286 | |||
Total assets | $ | 61,936 | $ | 64,547 | |
Liabilities and stockholders' equity | |||||
Current liabilities | |||||
Accounts payable | $ | 1,494 | $ | 3,172 | |
Accrued expenses and other current liabilities | 12,475 | 13,343 | |||
Operating lease obligations | 477 | 574 | |||
Current portion of long term debt | 1,316 | — | |||
Total current liabilities | 15,762 | 17,089 | |||
Non-current liabilities | |||||
Operating lease obligations, less current portion | 3,419 | 3,567 | |||
Long term debt, net | 1,571 | 2,800 | |||
Other non-current liabilities | 554 | 527 | |||
Total non-current liabilities | 5,544 | 6,894 | |||
Total liabilities | 21,306 | 23,983 | |||
Total stockholders' equity | 40,630 | 40,564 | |||
Total liabilities and stockholders' equity | $ | 61,936 | $ | 64,547 |
OCUGEN, INC. | |||||||||||||||
CONSOLIDATED STATEMENTS OF OPERATIONS | |||||||||||||||
(in thousands, except share and per share amounts) | |||||||||||||||
(Unaudited) | |||||||||||||||
Three months ended September 30, | Nine months ended September 30, | ||||||||||||||
2024 | 2023 | 2024 | 2023 | ||||||||||||
Collaborative arrangement revenue | $ | 1,136 | $ | 3,699 | $ | 3,291 | $ | 4,627 | |||||||
Total revenue | 1,136 | 3,699 | 3,291 | 4,627 | |||||||||||
Operating expenses | |||||||||||||||
Research and development | 8,108 | 7,048 | 23,836 | 31,794 | |||||||||||
General and administrative | 6,280 | 9,082 | 20,372 | 26,839 | |||||||||||
Total operating expenses | 14,388 | 16,130 | 44,208 | 58,633 | |||||||||||
Loss from operations | (13,252 | ) | (12,431 | ) | (40,917 | ) | (54,006 | ) | |||||||
Other income (expense), net | 282 | 714 | 743 | 1,898 | |||||||||||
Net loss | $ | (12,970 | ) | $ | (11,717 | ) | $ | (40,174 | ) | $ | (52,108 | ) |
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