Ocugen Provides Business Update and Third Quarter 2020 Financial Results
November 06 2020 - 7:30AM
Ocugen, Inc. (NASDAQ: OCGN), a biopharmaceutical company focused on
discovering, developing and commercializing transformative
therapies to cure blindness diseases, today reported third quarter
2020 financial results along with a general business update.
“I am proud of the advancements we have made this quarter in
developing our modifier gene therapy and novel biologic product
candidates. We remain on-track to achieve multiple near and
mid-term milestones with a plan to initiate four Phase 1/2a trials
during 2021 and 2022. Additionally, I am pleased that we have
raised approximately $28 million of gross proceeds in 2020,
which have extended our cash runway for continued development of
our product candidates,” said Dr. Shankar Musunuri, Chairman, Chief
Executive Officer and Co-Founder of Ocugen.
Business Highlights:
- Steady Progress Towards Starting OCU400 Clinical Trials in 2021
– Ocugen has received materials for its Good Laboratory Practice
(“GLP”) toxicology study from its manufacturing partner, CanSino
Biologics Inc. Ocugen has commenced the detailed design of its two
parallel Phase 1/2a trials and is on target to commence them in
2021.
- Manufacturing Contract for OCU200 – In October 2020, Ocugen
entered into an agreement with Kemwell Biopharma Pvt. Ltd
(“Kemwell”) to manufacture Ocugen’s biologic product candidate,
OCU200. Kemwell offers proven expertise in supporting companies
with process development and clinical and commercial manufacturing
of biologicals. The agreement with Kemwell is a fundamental step
for OCU200 to enter the clinic in the first half of 2022.
- Full Repayment of Unsecured Notes – From July through October
2020, Ocugen made aggregate prepayments of $4.5 million on the
unsecured notes associated with the April 2020 amendment and
exchange of its Series A Warrants. Following the October 2020
prepayments, the unsecured notes have been repaid in full and are
no longer outstanding.
- Capital Raised – In the third quarter, Ocugen sold an aggregate
of 27.0 million shares of common stock in an at-the-market
offering commenced in August 2020, generating net proceeds of
$10.1 million and increasing its cash runway into the third
quarter of 2021.
Third Quarter 2020 Financial Results:
- Ocugen’s cash, cash equivalents, and restricted cash totaled
$19.3 million as of September 30, 2020, compared to
$7.6 million as of December 31, 2019. The Company had
162.0 million shares of common stock outstanding at
September 30, 2020.
- Research and development expenses for the three months ended
September 30, 2020 were $1.5 million compared to
$1.3 million for the three months ended September 30, 2019.
General and administrative expenses for the three months ended
September 30, 2020 were $1.7 million compared to
$1.4 million for the three months ended September 30, 2019.
Ocugen reported a $0.07 loss per share for the three months ended
September 30, 2020 compared to a $3.55 loss per share for the three
months ended September 30, 2019.
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:LaVoieHealthScienceKatie
Gallagherkgallagher@lavoiehealthscience.com+1 617-792-3937
(tables to follow)
OCUGEN, INC.CONSOLIDATED
BALANCE SHEETS(UNAUDITED)
|
|
September 30, 2020 |
|
December 31, 2019 |
Assets |
|
|
|
|
Current assets |
|
|
|
|
Cash and cash equivalents |
|
$ |
19,105,830 |
|
|
$ |
7,444,052 |
|
Prepaid expenses and other current assets |
|
652,893 |
|
|
1,322,167 |
|
Asset held for sale |
|
— |
|
|
7,000,000 |
|
Total current assets |
|
19,758,723 |
|
|
15,766,219 |
|
Property and equipment, net |
|
214,100 |
|
|
222,464 |
|
Restricted cash |
|
151,196 |
|
|
151,016 |
|
Other assets |
|
415,555 |
|
|
667,747 |
|
Total
assets |
|
$ |
20,539,574 |
|
|
$ |
16,807,446 |
|
Liabilities and
stockholders’ equity |
|
|
|
|
Current liabilities |
|
|
|
|
Accounts payable |
|
$ |
222,340 |
|
|
$ |
1,895,613 |
|
Accrued expenses |
|
2,333,733 |
|
|
2,270,045 |
|
Short-term debt, net |
|
1,210,645 |
|
|
— |
|
Operating lease obligation |
|
164,808 |
|
|
172,310 |
|
Other current liabilities |
|
199,261 |
|
|
205,991 |
|
Total current liabilities |
|
4,130,787 |
|
|
4,543,959 |
|
Non-current liabilities |
|
|
|
|
Operating lease obligation, less current portion |
|
42,746 |
|
|
163,198 |
|
Long term debt, net |
|
1,944,396 |
|
|
1,072,123 |
|
Other non-current liabilities |
|
— |
|
|
9,755 |
|
Total liabilities |
|
6,117,929 |
|
|
5,789,035 |
|
Stockholders’ equity |
|
|
|
|
Common stock |
|
1,621,480 |
|
|
527,467 |
|
Treasury Stock |
|
(47,864 |
) |
|
(47,864 |
) |
Additional paid-in capital |
|
82,359,494 |
|
|
62,018,632 |
|
Accumulated deficit |
|
(69,511,465 |
) |
|
(51,479,824 |
) |
Total stockholders’
equity |
|
14,421,645 |
|
|
11,018,411 |
|
Total liabilities and
stockholders’ equity |
|
$ |
20,539,574 |
|
|
$ |
16,807,446 |
|
OCUGEN, INC.CONSOLIDATED
STATEMENTS OF OPERATIONS(UNAUDITED)
|
|
Three months ended September 30, |
|
Nine months ended September 30, |
|
|
2020 |
|
2019 |
|
2020 |
|
2019 |
Revenues |
|
|
|
|
|
|
|
|
Collaboration revenue |
|
$ |
— |
|
|
$ |
— |
|
|
$ |
42,620 |
|
|
$ |
— |
|
Total revenues |
|
— |
|
|
— |
|
|
42,620 |
|
|
— |
|
Operating expenses |
|
|
|
|
|
|
|
|
Research and development |
|
1,477,382 |
|
|
1,305,461 |
|
|
4,759,569 |
|
|
6,338,530 |
|
In-process research and development |
|
7,000,000 |
|
|
— |
|
|
7,000,000 |
|
|
— |
|
General and administrative |
|
1,704,598 |
|
|
1,408,350 |
|
|
5,760,398 |
|
|
3,544,847 |
|
Total operating expenses |
|
10,181,980 |
|
|
2,713,811 |
|
|
17,519,967 |
|
|
9,883,377 |
|
Loss from operations |
|
(10,181,980 |
) |
|
(2,713,811 |
) |
|
(17,477,347 |
) |
|
(9,883,377 |
) |
Other income (expense) |
|
|
|
|
|
|
|
|
Change in fair value of derivative liabilities |
|
— |
|
|
(18,512,204 |
) |
|
— |
|
|
(19,896,626 |
) |
Loss on debt conversion |
|
— |
|
|
— |
|
|
— |
|
|
(341,136 |
) |
Interest income |
|
42 |
|
|
136 |
|
|
594 |
|
|
1,107 |
|
Interest expense |
|
(291,909 |
) |
|
(796,141 |
) |
|
(554,801 |
) |
|
(1,753,172 |
) |
Other income (expense) |
|
— |
|
|
(751,261 |
) |
|
(87 |
) |
|
(751,493 |
) |
Total other income
(expense) |
|
(291,867 |
) |
|
(20,059,470 |
) |
|
(554,294 |
) |
|
(22,741,320 |
) |
Net loss |
|
$ |
(10,473,847 |
) |
|
$ |
(22,773,281 |
) |
|
$ |
(18,031,641 |
) |
|
$ |
(32,624,697 |
) |
Deemed dividend related to
Warrant Exchange |
|
— |
|
|
— |
|
|
(12,546,340 |
) |
|
— |
|
Net loss to common
stockholders |
|
$ |
(10,473,847 |
) |
|
$ |
(22,773,281 |
) |
|
$ |
(30,577,981 |
) |
|
$ |
(32,624,697 |
) |
|
|
|
|
|
|
|
|
|
Shares used in calculating net
loss per common share — basic and diluted |
|
141,591,218 |
|
|
6,411,308 |
|
|
92,764,157 |
|
|
5,839,840 |
|
Net loss per share of common
stock — basic and diluted |
|
$ |
(0.07 |
) |
|
$ |
(3.55 |
) |
|
$ |
(0.33 |
) |
|
$ |
(5.59 |
) |
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