Ocugen Provides Business Update and Second Quarter 2020 Financial Results
August 14 2020 - 6:30AM
Ocugen, Inc. (NASDAQ: OCGN), a biopharmaceutical company focused on
discovering, developing and commercializing transformative
therapies to cure blindness diseases, today reported second quarter
2020 financial results along with a general business update.
“I am very proud of the progress we have made this quarter as we
work to develop transformative therapies with the potential to cure
blindness diseases. Despite the challenges of the global pandemic,
we remain on track to enter the clinic next year with our first
gene therapy product candidate, OCU400, for retinitis pigmentosa.
Our second gene therapy product, OCU410, for dry age-related
macular degeneration and our first novel biologic, OCU200, for
major retinal diseases are on track to enter the clinic in 2022,”
said Dr. Shankar Musunuri, Chairman, Chief Executive Officer and
Co-Founder of Ocugen.
Business Highlights:
- Four Orphan Drug Designations (“ODD”) for OCU400 – In late July
2020, the United States Food and Drug Administration (“FDA”)
granted the third ODD for OCU400 for the treatment of rhodopsin
(“RHO”) mutation-associated retinal degeneration. The RHO mutation
is one of the more common mutations that cause retinitis pigmentosa
(“RP”), a group of rare genetic disorders, with the RHO mutation
representing about 12% of RP patients in the United States. In
early August 2020, the FDA granted another ODD for OCU400 for the
treatment of phosphodiesterase 6B (“PDE6B”) mutation-associated
RP.
- World Orphan Drug Congress USA 2020 Conference – On August 24,
2020, Dr. Rasappa Arumugham, Chief Scientific Officer of Ocugen,
will highlight Ocugen’s breakthrough modifier gene therapy platform
as part of the Next Generation Therapies Seminar.
- Chair Appointment for the Retina Scientific Advisory Board – In
June 2020, Ocugen announced the appointment of Dr. Mohamed Genead
as chair of the Ocugen, Inc. Retina Scientific Advisory Board,
which is comprised of prominent experts who provide strategic
advice, clinical and regulatory support, and scientific and
industry expertise. The Company believes Dr. Genead’s deep
experience in ophthalmology and gene therapy will be instrumental
as it advances its breakthrough modifier gene therapy platform into
the clinic next year.
- Discontinuance of OCU300 for ocular Graft vs. Host Disease and
Reduction in Force – In June 2020, after review of a pre-planned
interim sample size analysis which indicated the trial was unlikely
to meet its co-primary endpoints upon completion, Ocugen
discontinued the Phase 3 trial and initiated a workforce reduction
as part of this shift in focus towards its gene therapy platform
and novel biologics program aimed at curing blindness diseases.
Ocugen expects the workforce reduction will result in approximately
$2.0 million in annualized cost savings commencing in
2021.
- Extension of Cash Runway – Ocugen sold an aggregate of
59.1 million shares of common stock in separate at-the-market
offerings (“ATMs”) commenced in May 2020 and June 2020, generating
net proceeds of $15.4 million and increasing its cash runway
into the first quarter of 2021.
Second Quarter 2020 Financial Results:
- In April 2020, Ocugen completed an amendment and exchange of
its Series A Warrants for an aggregate of 21.9 million shares
of Ocugen’s common stock and non-interest-bearing unsecured notes
in the aggregate principal amount of $5.6 million. The Company
has made prepayments of $3.1 million on the unsecured notes
from proceeds received under the May 2020 and June 2020 ATMs.
- Ocugen’s cash, cash equivalents and restricted cash totaled
$15.1 million as of June 30, 2020, compared to
$7.6 million as of December 31, 2019. The Company had
135.0 million shares of common stock outstanding at
June 30, 2020.
- Research and development expenses for the three months ended
June 30, 2020 were $1.6 million compared to $1.2 million
for the three months ended June 30, 2019. General and
administrative expenses for the three months ended June 30, 2020
were $1.8 million compared to $1.1 million for the three
months ended June 30, 2019.
- Ocugen reported a net loss of $3.6 million, or $0.19 loss
per share, for the three months ended June 30, 2020, compared to a
net loss of $3.5 million, or $0.58 loss per share, for the three
months ended June 30, 2019.
Conference Call and Webcast Details
The Company has scheduled a conference call and
webcast for 8:30 a.m. Eastern Time today to discuss the 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
5587104. 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 transformative
therapies to cure blindness diseases. 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. 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 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 (the “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.
Corporate Contact:Ocugen, Inc.Sanjay
SubramanianChief Financial OfficerIR@Ocugen.com
Media Contact:LaVoieHealthScienceEmmie
Twomblyetwombly@lavoiehealthscience.com+1 857-389-6042
(tables to follow)
OCUGEN, INC.CONSOLIDATED
BALANCE SHEETS(UNAUDITED)
|
June 30, 2020 |
|
December 31, 2019 |
Assets |
|
|
|
Current assets |
|
|
|
Cash and cash equivalents |
$ |
14,968,161 |
|
|
|
$ |
7,444,052 |
|
|
Prepaid expenses and other current assets |
924,500 |
|
|
|
1,322,167 |
|
|
Asset held for sale |
7,000,000 |
|
|
|
7,000,000 |
|
|
Total current assets |
22,892,661 |
|
|
|
15,766,219 |
|
|
Property and equipment, net |
232,354 |
|
|
|
222,464 |
|
|
Restricted cash |
151,157 |
|
|
|
151,016 |
|
|
Other assets |
482,711 |
|
|
|
667,747 |
|
|
Total
assets |
$ |
23,758,883 |
|
|
|
$ |
16,807,446 |
|
|
Liabilities and
stockholders’ equity |
|
|
|
Current liabilities |
|
|
|
Accounts payable |
$ |
507,864 |
|
|
|
$ |
1,895,613 |
|
|
Accrued expenses |
2,084,915 |
|
|
|
2,270,045 |
|
|
Short-term debt, net |
4,068,176 |
|
|
|
— |
|
|
Operating lease obligation |
175,538 |
|
|
|
172,310 |
|
|
Other current liabilities |
204,860 |
|
|
|
205,991 |
|
|
Total current liabilities |
7,041,353 |
|
|
|
4,543,959 |
|
|
Non-current liabilities |
|
|
|
Operating lease obligation, less current portion |
75,577 |
|
|
|
163,198 |
|
|
Long term debt, net |
2,018,926 |
|
|
|
1,072,123 |
|
|
Other non-current liabilities |
— |
|
|
|
9,755 |
|
|
Total liabilities |
9,135,856 |
|
|
|
5,789,035 |
|
|
Stockholders’ equity |
|
|
|
Common stock |
1,351,281 |
|
|
|
527,467 |
|
|
Treasury Stock |
(47,864 |
) |
|
|
(47,864 |
) |
|
Additional paid-in capital |
72,357,228 |
|
|
|
62,018,632 |
|
|
Accumulated deficit |
(59,037,618 |
) |
|
|
(51,479,824 |
) |
|
Total stockholders’ equity |
14,623,027 |
|
|
|
11,018,411 |
|
|
Total liabilities and
stockholders’ equity |
$ |
23,758,883 |
|
|
|
$ |
16,807,446 |
|
|
OCUGEN, INC.CONSOLIDATED
STATEMENTS OF OPERATIONS(UNAUDITED)
|
Three months ended June 30, |
|
Six months ended June 30, |
|
2020 |
|
2019 |
|
2020 |
|
2019 |
Revenues |
|
|
|
|
|
|
|
Collaboration revenue |
$ |
42,620 |
|
|
|
$ |
— |
|
|
|
$ |
42,620 |
|
|
|
$ |
— |
|
|
|
Total revenues |
42,620 |
|
|
|
— |
|
|
|
42,620 |
|
|
|
— |
|
|
|
Operating expenses |
|
|
|
|
|
|
|
Research and development |
1,629,869 |
|
|
|
1,240,047 |
|
|
|
3,282,187 |
|
|
|
5,033,069 |
|
|
|
General and administrative |
1,779,016 |
|
|
|
1,088,477 |
|
|
|
4,055,800 |
|
|
|
2,136,497 |
|
|
|
Total operating expenses |
3,408,885 |
|
|
|
2,328,524 |
|
|
|
7,337,987 |
|
|
|
7,169,566 |
|
|
|
Loss from operations |
(3,366,265 |
) |
|
|
(2,328,524 |
) |
|
|
(7,295,367 |
) |
|
|
(7,169,566 |
) |
|
|
Other income (expense) |
|
|
|
|
|
|
|
Change in fair value of derivative liabilities |
— |
|
|
|
(608,149 |
) |
|
|
— |
|
|
|
(1,384,422 |
) |
|
|
Loss on debt conversion |
— |
|
|
|
(341,136 |
) |
|
|
— |
|
|
|
(341,136 |
) |
|
|
Interest income |
433 |
|
|
|
377 |
|
|
|
552 |
|
|
|
971 |
|
|
|
Interest expense |
(248,143 |
) |
|
|
(261,562 |
) |
|
|
(262,892 |
) |
|
|
(957,031 |
) |
|
|
Other income (expense) |
— |
|
|
|
184 |
|
|
|
(87 |
) |
|
|
(232 |
) |
|
|
Total other income
(expense) |
(247,710 |
) |
|
|
(1,210,286 |
) |
|
|
(262,427 |
) |
|
|
(2,681,850 |
) |
|
|
Net loss |
$ |
(3,613,975 |
) |
|
|
$ |
(3,538,810 |
) |
|
|
$ |
(7,557,794 |
) |
|
|
$ |
(9,851,416 |
) |
|
|
Deemed dividend related to
Warrant Exchange |
(12,546,340 |
) |
|
|
— |
|
|
|
(12,546,340 |
) |
|
|
— |
|
|
|
Net loss to common
stockholders |
$ |
(16,160,315 |
) |
|
|
$ |
(3,538,810 |
) |
|
|
$ |
(20,104,134 |
) |
|
|
$ |
(9,851,416 |
) |
|
|
|
|
|
|
|
|
|
|
Shares used in calculating net
loss per common share — basic and diluted |
83,537,463 |
|
|
|
6,067,401 |
|
|
|
68,082,346 |
|
|
|
5,461,576 |
|
|
|
Net loss per share of common
stock — basic and diluted |
$ |
(0.19 |
) |
|
|
$ |
(0.58 |
) |
|
|
$ |
(0.30 |
) |
|
|
$ |
(1.80 |
) |
|
|
Ocugen (NASDAQ:OCGN)
Historical Stock Chart
From Apr 2024 to May 2024
Ocugen (NASDAQ:OCGN)
Historical Stock Chart
From May 2023 to May 2024