Ocugen, Inc. (Ocugen or the Company) (NASDAQ: OCGN), a
biotechnology company focused on discovering, developing, and
commercializing novel gene and cell therapies and vaccines, today
provided a general business update with certain financials for the
year ending 2023.
"In 2023, our diligent efforts laid the foundation for continued
advancement towards our clinical and operational goals with a focus
on our game-changing modifier gene therapy platform,” said Dr.
Shankar Musunuri, Chairman, CEO, and Co-Founder of Ocugen. “2024 is
already proving to be a pivotal year with considerable developments
in our modifier gene therapy programs for blindness diseases, and
an increased understanding of the value of these assets among our
stakeholders. Promising initial OCU400 Phase 1/2 study results for
RP patients have been recognized by the FDA through the RMAT
designation, potentially accelerating our path to deliver this
critical therapy. With the FDA’s support, we feel confident that
this trial will continue to demonstrate the benefits of our
gene-agnostic mechanism utilizing a potential one-time treatment
for life via a single sub-retinal injection.”
Additionally, the Company’s OCU410 and OCU410ST modifier gene
therapy programs are currently enrolling patients with GA secondary
to dry AMD (dAMD) and Stargardt disease, respectively. In February
2024, Ocugen completed dosing patients in the first cohort of its
Phase 1/2 OCU410ST trial for Stargardt disease, and in March,
dosing was completed for the first cohort of the OCU410 trial for
GA.
The current treatment landscape for both GA and Stargardt
disease is extremely limited. The estimated 1 million patient GA
market in the U.S. saw some momentum with recent drug approvals.
However, these treatment options have significant limitations, as
they require multiple injections per year (impacting compliance)
and only target one pathway contributing to GA. OCU410 -regulates
multiple pathways involved with the disease including: lipid
metabolism, regulation of inflammation, oxidative stress, and
membrane attack complex (complement); and has the potential to
provide a one-time treatment for life. Presently, there is no
approved treatment for people living with Stargardt disease – an
orphan blindness disease that affects approximately 40,000 people
in the U.S. alone.
“As we pursue our pioneering efforts to change the paradigm for
gene therapy, our dedication is unwavering to patients living with
a constant fear of losing their sight,” said Dr. Musunuri. "With
millions of people affected by these conditions, our mission is
clear: to deliver treatments that cannot only stop disease
progression but potentially help to preserve or improve sight and
allow patients to maintain independence.”
Ocugen's team has strategically allocated resources to drive the
ongoing progress of its gene therapy trials and continues to pursue
government funding to support its vaccines programs. During the
fourth quarter of 2023, the Company announced its mucosal vaccine
candidate, OCU500, was chosen for the multi-billion-dollar NIAID
Project NextGen initiative. As a result, OCU500 is slated to enter
clinical trials mid-2024. In the planned Phase 1 clinical trial,
OCU500 will be tested via two different mucosal routes: inhalation
into the lungs and as a nasal spray. All administration of the
clinical trial is being led by NIAID.
NeoCart®, the Company’s 3-D regenerative cell therapy platform
for cartilage repair, remains on track to begin a Phase 3 trial by
the latter half of 2024 subject to availability of funding. Ocugen
completed renovations on a world-class cGMP facility last year to
produce NeoCart®, which has since received its full final clearance
and occupancy certificate. Simultaneously, the Company is
evaluating opportunities for NeoCart to maximize value for
shareholders and patients.
Modifier Gene Therapies
-
OCU400 – Received alignment with FDA for broad RP
indication in the Phase 3 clinical trial of OCU400—the first gene
therapy program to receive a broad indication for RP. The modified
Phase 3 trial design will include 150 adult and pediatric RP
patients with RHO and other gene mutations associated with RP. In
December, the FDA granted RMAT designation to OCU400 for the
treatment of RP. RP affects more than 100,000 people in the U.S.
and 1.6 million globally.
- OCU410
– Currently in Phase 1/2 stage of clinical development
with active patient enrollment. The first patient was dosed in the
Phase 1/2 trials to assess the safety and efficacy of OCU410 for GA
secondary to dAMD in December 2023. Dosing is complete for Cohort 1
(low dose).
- OCU410ST – Currently in Phase 1/2 stage of
clinical development with active patient enrollment. The first
patient was dosed in the Phase 1/2 trials to assess the safety and
efficacy of OCU410ST for Stargardt disease in November 2023. Dosing
is complete for Cohort 1 (low dose). The Data and Safety Monitoring
Board for the OCU410ST clinical trial determined that the safety
and tolerability profile for OCU410ST is favorable and approved to
proceed dosing with the medium dose of OCU410ST in the
dose-escalation phase of the study.
Financial Results
- The Company intends to restate its consolidated financial
statements as of and for the year ended December 31, 2022, in
connection with the filing of its 2023 Form 10-K. Similarly, the
Company will include restated unaudited financial information for
each of the first three quarters of 2023 and 2022 in its 2023 Form
10-K (each such annual and quarterly period to be restated, a
“Restated Period”).
- The identified errors in each of the Restated Periods
relate to the Company’s non-cash accounting for the estimated
costs in one of its collaboration arrangements. However, the
Company does not expect the errors to result in any impact on its
cash position, cash runway, or financial projections.
- Ocugen’s cash, cash equivalents, and investments totaled $39.5
million as of December 31, 2023, compared to $90.9 million as of
December 31, 2022. The Company estimates that its current cash,
cash equivalents, and investments will enable it to fund its
operations into the fourth quarter of 2024. The Company had 256.6
million shares of common stock outstanding as of December 31,
2023.
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
callersConference ID:
4947142Webcast: 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 patients’
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
StatementsThis 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 include, but are not limited to, statements regarding
the Company’s clinical development activities and related
anticipated timelines; strategy, business plans and objectives for
its clinical stage programs; plans and timelines for the
preclinical and clinical development of its 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;
the ability to initiate new clinical programs; Ocugen’s financial
condition and the expected impact of the restatement of certain
financials. 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, as well as discussions of potential risks, uncertainties, and
other important factors in Ocugen’s subsequent filings with the
SEC. Any forward-looking statements that we make in this press
release speak only as of the date of this press release and should
not be relied upon as representing its views as of any subsequent
date. 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 HamiltonHead of
CommunicationsIR@ocugen.com
Ocugen (NASDAQ:OCGN)
Historical Stock Chart
From Mar 2024 to Apr 2024
Ocugen (NASDAQ:OCGN)
Historical Stock Chart
From Apr 2023 to Apr 2024