Comera Life Sciences Holdings, Inc. (Nasdaq: CMRA), a life sciences
company developing a new generation of biologic medicines to
improve patient access, safety, and convenience, today reported
financial results for the third quarter ended September 30, 2023,
and provided a business update.
“Comera continues to generate significant
momentum, by expanding our patent portfolio, strengthening our cash
position and advancing key partnerships. These accomplishments
allow us to continue executing on our core value drivers, and
increase value for our shareholders and partners,” said Jeffrey
Hackman, Chairman and Chief Executive Officer of Comera. “As our
business advances and we execute our goals and drive our value
proposition, we remain focused on our mission to improve patient
quality of life and reduce healthcare costs by leveraging our
SQore™ platform to transform the delivery of biologics from
intravenous to self-administered subcutaneous forms.”
Recent Business Highlights
- Final stage of
technical evaluation is near completion as part of an ongoing
research collaboration with Regeneron, a leading U.S. biotechnology
company. The partnership includes a right to negotiate a license
after the technical evaluation is complete. Technical evaluation is
expected to be completed in Q4 2023.
- Presented
research demonstrating SQore platform’s capabilities in the
development of subcutaneous monoclonal antibody formulations at the
PODD: Partnerships in Drug Delivery conference in Boston, Mass. The
data presented highlighted that the SQore platform has successfully
reduced the viscosity of a diverse range of monoclonal antibodies,
demonstrating the platform’s versatility and remarkable
capabilities.
- Completed
previously announced $4.1 million private placement of shares of
its common stock, and accompanying warrants to purchase shares of
its common stock, to existing stockholders at a purchase price of
$0.51125 per share.
- Published data
in the Journal of Pharmaceutical Sciences that supports further
development of caffeine as a viscosity reducing agent for
subcutaneous formulations of monoclonal antibodies. The results
show the rapid dissociation of caffeine upon subcutaneous injection
and that caffeine does not affect pharmacokinetic profiles of the
model monoclonal antibody, both of which are critical features of a
successful subcutaneous formulation.
- Received a
Notice of Intention to Grant a European patent by the European
Patent Office, which would represent the first granted patent in
Europe for Comera’s SQore platform technology.
- Expanded SQore
platform patent portfolio with the issuance of four new patents and
two new notices of allowance. The six new patents, three issued in
the United States and three covering Canada, Korea and India,
expand the number of proprietary viscosity reducing excipients in
Comera’s SQore platform and significantly broaden claims covered by
previously issued patents.
- Entered into a
partnership with Quality Chemical Laboratories, Inc. to manufacture
one of Comera’s lead SQore excipients, as part of a broader
strategy to secure the GMP manufacturing and supply chain of key
proprietary technology owned by the Company. The collaboration
gives Comera full control over supply chain and greater flexibility
to support product development needs.
Third Quarter 2023 Financial Results
Comera reported revenues of $136 thousand for
the three months ended September 30, 2023, compared to $235
thousand for the same period in 2022, with the decrease primarily
related to a reduction in hours incurred on the ongoing research
collaboration with Regeneron, which is now in its final stages.
Cost of revenue totaled $42 thousand for the
three months ended September 30, 2023, compared to $61 thousand for
the same period in 2022, with the decrease primarily related to the
hours incurred on the Regeneron project during the three months
ending September 30, 2023.
R&D expenses totaled $366 thousand for the three months
ended September 30, 2023, compared to $395 thousand for the same
period in 2022. The overall decrease of approximately $29 thousand
is primarily related to a reduction in employee compensation
expense in the three months ended September 30, 2023.
General and administrative expenses totaled $1.9
million, inclusive of $260 thousand of non-cash stock compensation
expense, for the three months ended September 30, 2023, compared to
$2.3 million for the same period in 2022. The overall decrease of
approximately $429 thousand is primarily related to expenses in
connection with the Company’s transition to operating a public
company in the three months ended September 30, 2022, and an
overall reduction in general and administrative spending.
Comera reported a net loss of $2.2 million, or
$0.10 loss per share for the three months ended September 30, 2023,
compared to a net loss of $3.2 million, or $0.20 loss per share,
for the same period in 2022. The decrease was primarily due to an
overall reduction in spending in the current year and higher
non-operating expense in the prior year.
Comera had approximately $1.8 million in cash at
September 30, 2023.
About Comera Life Sciences
Leading a compassionate new era in medicine,
Comera Life Sciences is applying a deep knowledge of formulation
science and technology to transform essential biologic medicines
from intravenous (IV) to subcutaneous (SQ) forms. The goal of this
approach is to provide patients with the freedom of self-injectable
care, reduce institutional dependency and to put patients at the
center of their treatment regimen.
To learn more about the Comera Life Sciences
mission, as well as the proprietary SQore™ platform, visit
https://comeralifesciences.com/.
Forward-Looking Statements
This press release includes “forward-looking
statements” within the meaning of the federal securities laws.
These forward-looking statements generally are identified by the
words “believe,” “project,” “expect,” “anticipate,” “estimate,”
“intend,” “strategy,” “future,” “opportunity,” “plan,” “may,”
“should,” “will,” “would,” “will be,” “will continue,” “will likely
result,” and similar expressions. Forward-looking statements are
predictions, projections and other statements about future events
(including, for example, statements related to the Company’s
expectation that the technical evaluation as part of the research
collaboration with Regeneron will be completed, the Company’s
expectation that it will enter into negotiations with Regeneron for
a licensing arrangement and the extent to which that licensing
arrangement may be profitable, and dealings with the Company’s
SQore™ platform) that are based on current expectations and
assumptions and, as a result, are subject to risks and
uncertainties. Many factors could cause actual future events to
differ materially from the forward-looking statements in this
document, including, but not limited to: the Company’s ability to
maintain the listing of its securities on the Nasdaq Capital
Market; the price of the Company’s securities may be volatile due
to a variety of factors, including changes in the competitive and
highly regulated industries in which the Company plans to operate,
variations in performance across competitors, changes in laws and
regulations affecting the Company’s business and changes in the
capital structure; the Company’s ability to execute on its business
plans, forecasts, and other expectations and identify and realize
additional opportunities; the risk of economic downturns and the
possibility of rapid change in the highly competitive industry in
which the Company operates; the risk that the Company and its
current and future collaborators are unable to successfully develop
and commercialize the Company’s products or services, or experience
significant delays in doing so; the risk that we will be unable to
continue to attract and retain third-party collaborators, including
collaboration partners and licensors; the risk that the Company may
never achieve or sustain profitability; the risk that the Company
will need to raise additional capital to execute its business plan,
which may not be available on acceptable terms or at all; the risk
that the Company experiences difficulties in managing its growth
and expanding operations; the risk that third-party suppliers and
manufacturers are not able to fully and timely meet their
obligations; the risk that the Company is unable to secure or
protect its intellectual property; the risk that the Company is
unable to secure regulatory approval for its product candidates;
the effect of any resurgence of the COVID-19 pandemic or other
public health emergencies on the Company’s business; general
economic conditions; and other risks and uncertainties described in
Item 1A of Part I of the Company’s Annual Report on Form 10-K filed
with the SEC on March 17, 2023 under “Risk Factors” and in other
filings that have been made or will be made with the SEC. The
foregoing list of factors is not exhaustive. Forward-looking
statements speak only as of the date they are made. Readers are
cautioned not to put undue reliance on forward-looking statements,
and Comera assumes no obligation and does not intend to update or
revise these forward-looking statements, whether as a result of new
information, future events, or otherwise. Comera can give no
assurance that it will achieve its expectations.
Contacts
Comera Investor
John Woolford ICR Westwicke John.Woolford@westwicke.com
Comera Press
Jon Yu ICR WestwickeComeraPR@westwicke.com
COMERA LIFE SCIENCES HOLDINGS,
INC.CONSOLIDATED BALANCE SHEETS
(unaudited)
|
|
|
|
|
|
|
September 30, |
|
December
31, |
|
|
|
2023 |
|
|
|
2022 |
|
Assets |
|
|
|
|
Current
assets: |
|
|
|
|
Cash and cash equivalents |
|
$ |
1,767,870 |
|
|
$ |
446,607 |
|
Restricted cash - current |
|
|
— |
|
|
|
1,505,625 |
|
Accounts receivable |
|
|
— |
|
|
|
34,320 |
|
Deferred issuance costs |
|
|
— |
|
|
|
90,047 |
|
Prepaid expenses and other current assets |
|
|
862,626 |
|
|
|
986,499 |
|
Total current assets |
|
|
2,630,496 |
|
|
|
3,063,098 |
|
Restricted
cash - non-current |
|
|
50,000 |
|
|
|
50,000 |
|
Property and
equipment, net |
|
|
186,738 |
|
|
|
257,186 |
|
Right-of-use
asset |
|
|
161,515 |
|
|
|
313,629 |
|
Security
deposit |
|
|
43,200 |
|
|
|
43,200 |
|
Total assets |
|
$ |
3,071,949 |
|
|
$ |
3,727,113 |
|
Liabilities, Convertible Preferred Stock and Stockholders’
Deficit |
|
|
|
|
Current
liabilities: |
|
|
|
|
Accounts payable |
|
$ |
1,144,822 |
|
|
$ |
1,458,267 |
|
Accrued expenses and other current liabilities |
|
|
1,226,129 |
|
|
|
1,295,764 |
|
Insurance premium financing |
|
|
389,872 |
|
|
|
455,562 |
|
Deposit liability |
|
|
— |
|
|
|
1,505,625 |
|
Deferred revenue |
|
|
— |
|
|
|
144,280 |
|
Lease liability - current |
|
|
171,596 |
|
|
|
199,184 |
|
Total current liabilities |
|
|
2,932,419 |
|
|
|
5,058,682 |
|
Derivative
warrant liabilities |
|
|
37,266 |
|
|
|
277,507 |
|
Lease
liability - noncurrent |
|
|
— |
|
|
|
120,302 |
|
Total liabilities |
|
|
2,969,685 |
|
|
|
5,456,491 |
|
Commitments
and contingencies |
|
|
|
|
Preferred
stock, $0.0001 par value; 1,000,000 shares authorized; 3,895.53 and
4,305 shares designated Series A convertible preferred stock at
September 30, 2023 and December 31, 2022; 3,895.53 and 4,305 shares
issued and outstanding at September 30, 2023 and December 31, 2022,
respectively |
|
|
4,322,866 |
|
|
|
4,517,710 |
|
Stockholders’ deficit: |
|
|
|
|
Common stock, $0.0001 par value; 150,000,000 shares authorized;
30,737,796 and 16,709,221 shares issued and outstanding at
September 30, 2023 and December 31, 2022, respectively |
|
|
2,759 |
|
|
|
1,671 |
|
Additional paid-in capital |
|
|
36,727,205 |
|
|
|
28,655,164 |
|
Accumulated deficit |
|
|
(40,950,566 |
) |
|
|
(34,903,923 |
) |
Total stockholders’ deficit |
|
|
(4,220,602 |
) |
|
|
(6,247,088 |
) |
Total liabilities, convertible preferred stock and stockholders’
deficit |
|
$ |
3,071,949 |
|
|
$ |
3,727,113 |
|
|
|
|
|
|
COMERA LIFE SCIENCES HOLDINGS,
INC.CONSOLIDATED STATEMENTS OF OPERATIONS AND
COMPREHENSIVE LOSS (unaudited)
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended September 30, |
|
Nine months ended September 30, |
|
|
|
2023 |
|
|
|
2022 |
|
|
|
2023 |
|
|
|
2022 |
|
Revenue |
|
$ |
136,310 |
|
|
$ |
234,922 |
|
|
$ |
844,280 |
|
|
$ |
476,982 |
|
Cost of revenue |
|
|
41,961 |
|
|
|
60,963 |
|
|
|
214,520 |
|
|
|
160,030 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
Research and development |
|
|
366,015 |
|
|
|
394,800 |
|
|
|
945,415 |
|
|
|
1,250,570 |
|
General and administrative |
|
|
1,885,405 |
|
|
|
2,314,554 |
|
|
|
5,822,107 |
|
|
|
8,027,316 |
|
Total operating expenses |
|
|
2,251,420 |
|
|
|
2,709,354 |
|
|
|
6,767,522 |
|
|
|
9,277,886 |
|
Loss from operations |
|
|
(2,157,071 |
) |
|
|
(2,535,395 |
) |
|
|
(6,137,762 |
) |
|
|
(8,960,934 |
) |
Other income (expense), net: |
|
|
|
|
|
|
|
|
Change in fair value of derivative warrant liabilities |
|
|
9,325 |
|
|
|
500,327 |
|
|
|
108,678 |
|
|
|
1,954,767 |
|
Reverse recapitalization issuance costs in excess of gross
proceeds |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(6,566,821 |
) |
Common stock purchase agreement issuance costs |
|
|
— |
|
|
|
(1,029,077 |
) |
|
|
— |
|
|
|
(1,029,077 |
) |
Interest expense |
|
|
(5,965 |
) |
|
|
(12,696 |
) |
|
|
(17,559 |
) |
|
|
(12,773 |
) |
Other expense, net |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(426,666 |
) |
Total other income (expense), net |
|
|
3,360 |
|
|
|
(541,446 |
) |
|
|
91,119 |
|
|
|
(6,080,570 |
) |
Net loss and comprehensive loss |
|
|
(2,153,711 |
) |
|
|
(3,076,841 |
) |
|
|
(6,046,643 |
) |
|
|
(15,041,504 |
) |
Less: accretion of convertible preferred stock to redemption
value |
|
|
(85,468 |
) |
|
|
(86,816 |
) |
|
|
(258,156 |
) |
|
|
(287,984 |
) |
Net loss attributable to common stockholders |
|
$ |
(2,239,179 |
) |
|
$ |
(3,163,657 |
) |
|
$ |
(6,304,799 |
) |
|
$ |
(15,329,488 |
) |
Net loss per share attributable to common stockholders — basic and
diluted |
|
$ |
(0.10 |
) |
|
$ |
(0.20 |
) |
|
$ |
(0.31 |
) |
|
$ |
(1.85 |
) |
Weighted-average number of common shares used in computing net loss
per share attributable to common stockholders — basic and
diluted |
|
|
23,113,051 |
|
|
|
16,024,011 |
|
|
|
20,448,666 |
|
|
|
8,294,938 |
|
|
|
|
|
|
|
|
|
|
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