Ocugen Provides Business Update & Second Quarter 2022 Financial Results
August 05 2022 - 7:30AM
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
reported financial results for the quarter ended June 30, 2022, and
provided a general business update.
“The second quarter was marked by several important milestones,”
said Dr. Shankar Musunuri, Chairman, Chief Executive Officer, and
Co-Founder of Ocugen. “On the vaccine front, we continued to work
diligently with our co-development partner, Bharat Biotech, to
ensure we execute our planned clinical and commercial objectives
for COVAXIN™ – a whole-virion inactivated COVID-19 vaccine
candidate.”
“We are also excited and encouraged by the positive momentum of
our investigational modifier gene therapy platform, with the
potential to address many different gene mutations in the retina
and look forward to bringing hope to patients for whom no treatment
options exist,” Dr. Musunuri added.
During the second quarter, Ocugen expanded its dynamic clinical
product pipeline with the introduction of NeoCart®, an innovative
Phase 3-ready cell therapy platform. The U.S. Food and Drug
Administration (FDA) recently granted NeoCart® a Regenerative
Medicine Advanced Therapy (RMAT) designation for the repair of
full-thickness lesions of the knee cartilage in adults, and this
candidate, if approved, offers the potential for a new therapeutic
option in this area.
“With our diversified portfolio, Ocugen is well-positioned to
advance our product development efforts and we look forward to
sharing key data as these programs progress,” Dr. Musunuri
concluded.
Clinical and Business Updates
Vaccines
- COVAXIN™ Development in the United States –
The Phase 2/3 immuno-bridging and broadening clinical trial,
OCU-002, for COVAXIN™ is progressing well.
- The Company is actively engaged in planning for the initiation
of an adult safety clinical trial this year.
- COVAXIN™ Data Published in Scientific Journals
– In June 2022, positive pediatric Phase 2/3 study results in
children aged 2-18 years were published in The Lancet Infectious
Diseases. A study published in Nature Scientific Reports in July
shows that COVAXIN™ (BBV152) generated a persistent cell mediated
memory immune response for up to 12 months. Additionally, a booster
dose is safe and ensures persistent immunity to minimize
breakthrough infections of COVID-19.
Gene Therapies
- OCU400 Clinical Trial – Dosing of subjects
with retinitis pigmentosa in Cohort 1 was completed. Previously,
the Company reported “first patient, first dose” in late March
2022.
- The Independent Data and Safety Monitoring Board (DSMB) for the
clinical trial recently completed a review of safety data based on
dosing from Cohort 1 and recommends proceeding to dosing in Cohort
2. The Company expects to begin dosing in Cohort 2 this month.
- OCU410 Development Program – Ocugen is
conducting IND-enabling studies as per discussions with the FDA. A
clinical trial is scheduled to begin next year, and the Company is
currently manufacturing materials to support the clinical
trial.
- Improved Patent Estate – In June 2022, the
Company announced that the United States Patent and Trademark
Office issued U.S. Patent No. 11,351,225, which is directed to
methods for preventing or treating an ocular disease or disorder
associated with retinal degenerative disease. The patent covers the
use of a nuclear hormone receptor gene, such as nuclear receptor
subfamily 2 group E member 3 (NR2E3), RAR-related orphan receptor A
(RORA), Nuclear Protein 1, Transcriptional Regulator (NUPR1), and
Nuclear Receptor Subfamily 2 Group C Member 1 (NR2C1), in treating
retinal degenerative diseases as well as reducing the risk of
developing such diseases.
Cell Therapies
- Expansion of Product Candidate Pipeline with
NeoCart® – Ocugen added NeoCart®, a Phase 3-ready cell
therapy platform technology to its diverse product candidate
pipeline. The Company originally acquired NeoCart® as part of the
Company’s reverse merger with Histogenics Corporation in 2019.
Ocugen is currently working with the FDA to finalize the Phase 3
protocol necessary to advance the clinical development program of
NeoCart®. Also, the Company entered into a collaborative research
agreement with Brigham and Women’s Hospital, Harvard Medical
School, to support NeoCart® development and explore expansion of
the pipeline.
Other Business
- At-the-Market Stock Issuance – In June 2022,
the Company announced it had entered into an At Market Issuance
Sales Agreement relating to the sale of shares of Ocugen’s common
stock having an aggregate gross sales price of up to $160.0
million. Proceeds will be used for general corporate purposes.
- Community Recognition – In June 2022, the
Philadelphia Business Journal named Ocugen among the region’s “2022
Best Places to Work.”
Second Quarter 2022 Financial Results
- The Company’s cash, cash equivalents, and restricted cash
totaled $115.0 million as of June 30, 2022, compared to $95.1
million as of December 31, 2021. The Company believes that its
current cash and cash equivalents balance will enable it to fund
its operations into the second quarter of 2023. The Company had
216.1 million shares of common stock outstanding as of June 30,
2022.
- Research and development expenses for the three months ended
June 30, 2022, were $9.0 million compared to $18.9 million for the
three months ended June 30, 2021. Research and development expenses
for the three months ended June 30, 2021, included a $15.0 million
upfront payment to Bharat Biotech for the right and license to
COVAXIN™ development, manufacturing, and commercialization in
Canada.
- General and administrative expenses for the three months ended
June 30, 2022, were $10.6 million compared to $6.8 million for the
three months ended June 30, 2021.
- Ocugen reported a $0.09 net loss per share for the three months
ended June 30, 2022, compared to a $0.13 net loss per share for the
three months ended June 30, 2021.
Conference Call and Webcast DetailsOcugen 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
executive 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 using the
following details:
Dial-in Numbers: (800) 715-9871 for U.S.
callers and (646) 307-1963 for international
callersConference ID:
7036957Webcast: 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 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 Twitter 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
forward-looking statements include, but are not limited to,
statements about the potential for NeoCart® (autologous
chondrocyte-derived neocartilage), if approved, to provide an
innovative new option for the repair of full-thickness lesions of
the knee cartilage in adults, as well as Ocugen’s intention to
begin dosing in Cohort 2 of the OCU400 clinical trial this month.
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 HamiltonHead of
CommunicationsIR@ocugen.com
(Tables to follow)
OCUGEN, INC.
CONSOLIDATED BALANCE SHEETS
(in thousands)
(Unaudited)
|
June 30, 2022 |
|
December 31, 2021 |
Assets |
|
|
|
Current assets |
|
|
|
Cash and cash equivalents |
$ |
115,005 |
|
|
$ |
94,958 |
|
Prepaid expenses and other current assets |
|
7,564 |
|
|
|
7,688 |
|
Total current assets |
|
122,569 |
|
|
|
102,646 |
|
Property and equipment, net |
|
3,153 |
|
|
|
1,164 |
|
Restricted cash |
|
— |
|
|
|
151 |
|
Other assets |
|
4,366 |
|
|
|
1,800 |
|
Total
assets |
$ |
130,088 |
|
|
$ |
105,761 |
|
Liabilities and stockholders' equity |
|
|
|
Current liabilities |
|
|
|
Accounts payable |
$ |
5,921 |
|
|
$ |
2,312 |
|
Accrued expenses |
|
4,103 |
|
|
|
4,325 |
|
Operating lease obligations |
|
314 |
|
|
|
363 |
|
Total current liabilities |
|
10,338 |
|
|
|
7,000 |
|
Non-current liabilities |
|
|
|
Operating lease obligations, less current portion |
|
3,892 |
|
|
|
1,231 |
|
Long term debt, net |
|
1,750 |
|
|
|
1,712 |
|
Total
liabilities |
|
15,980 |
|
|
|
9,943 |
|
Stockholders' equity |
|
|
|
Convertible preferred stock |
|
1 |
|
|
|
1 |
|
Common stock |
|
2,163 |
|
|
|
1,995 |
|
Treasury stock |
|
(48 |
) |
|
|
(48 |
) |
Additional paid-in capital |
|
281,139 |
|
|
|
225,537 |
|
Accumulated other comprehensive income |
|
10 |
|
|
|
— |
|
Accumulated deficit |
|
(169,157 |
) |
|
|
(131,667 |
) |
Total
stockholders' equity |
|
114,108 |
|
|
|
95,818 |
|
Total liabilities and stockholders' equity |
$ |
130,088 |
|
|
$ |
105,761 |
|
OCUGEN, INC.
CONSOLIDATED STATEMENTS OF
OPERATIONS
(in thousands, except share and per share
amounts)
(Unaudited)
|
Three months ended June 30, |
|
Six months ended June 30, |
|
|
2022 |
|
|
|
2021 |
|
|
|
2022 |
|
|
|
2021 |
|
Operating expenses |
|
|
|
|
|
|
|
Research and development |
$ |
9,007 |
|
|
$ |
18,853 |
|
|
$ |
16,922 |
|
|
$ |
21,725 |
|
General and administrative |
|
10,558 |
|
|
|
6,757 |
|
|
|
20,677 |
|
|
|
10,942 |
|
Total operating expenses |
|
19,565 |
|
|
|
25,610 |
|
|
|
37,599 |
|
|
|
32,667 |
|
Loss from operations |
|
(19,565 |
) |
|
|
(25,610 |
) |
|
|
(37,599 |
) |
|
|
(32,667 |
) |
Other income (expense),
net |
|
94 |
|
|
|
(342 |
) |
|
|
109 |
|
|
|
(362 |
) |
Net loss |
$ |
(19,471 |
) |
|
$ |
(25,952 |
) |
|
$ |
(37,490 |
) |
|
$ |
(33,029 |
) |
Shares used in calculating net
loss per common share — basic and diluted |
|
215,862,977 |
|
|
|
195,572,189 |
|
|
|
210,806,330 |
|
|
|
190,960,775 |
|
Net loss per share of common
stock — basic and diluted |
$ |
(0.09 |
) |
|
$ |
(0.13 |
) |
|
$ |
(0.18 |
) |
|
$ |
(0.17 |
) |
Ocugen (NASDAQ:OCGN)
Historical Stock Chart
From Mar 2024 to Apr 2024
Ocugen (NASDAQ:OCGN)
Historical Stock Chart
From Apr 2023 to Apr 2024