Comera Life Sciences Holdings, Inc. (Nasdaq: CMRA), a life
sciences company developing a new generation of bio-innovative
biologic medicines to improve patient access, safety, and
convenience, today reported financial results for the first quarter
ended March 31, 2023, and provided a business update.
“Comera continued to execute on its core value
drivers, including significant advancement of its ongoing
pharmaceutical partnerships, including our collaboration with
Regeneron, and sustained progression of our proprietary programs,
led by CLS-001, a subcutaneous formulation of vedolizumab,” said
Jeffrey Hackman, Chairman and Chief Executive Officer of Comera.
“As we strive to drive value for both shareholders and patients, we
remain focused on our mission to transform the patient experience
by enabling the delivery of biologics from intravenous to
subcutaneous form allowing patients to self-medicate at home and
ultimately reduce healthcare costs, improving quality of life.”
Recent Business Highlights
- Significant
progress in its ongoing research collaboration with Regeneron, a
leading U.S. biotechnology company. The partnership includes a
right to negotiate a license after technical evaluation is
complete.
- Further
development of its lead pipeline candidate CLS-001 (SQ
vedolizumab), highlighted by identification of a lead formulation
for a once-monthly SQ dose. Vedolizumab, currently marketed as
Entyvio in the United States as an IV formulation and an IV and
biweekly SQ formulation outside of the United States, is used for
the treatment of IBD including Crohn’s disease and ulcerative
colitis. Comera believes that a once-monthly SQ form could have
significant advantages for patients and the healthcare system.
- Joined the
Subcutaneous Drug Development & Delivery Consortium (SC
Consortium) to advance the science, technology, and best practices
for SQ drug development and delivery.
- In April 2023,
announced the expansion of its patent portfolio with one new patent
granted in South Korea and two Notices of Allowance in the United
States and Japan covering expansion of claims, geographic coverage,
and exclusive rights pertaining to certain excipients in its
proprietary SQore™ platform.
- In January
2023, announced the completion of a private placement of 2,406,242
units, at a purchase price of $1.48 per unit, resulting in gross
proceeds of approximately $3.6 million and with each unit
consisting of one share of the Company’s common stock and one
five-year warrant to purchase two shares of the Company’s common
stock at an exercise price of $1.23 per share.
First Quarter 2023 Financial Results
Comera reported revenues of $393 thousand for
the three months ended March 31, 2023, compared to $95 thousand for
the same period in 2022, with the increase primarily related to the
expansion of its ongoing research collaboration with Regeneron.
Cost of revenue totaled $117 thousand for the
three months ended March 31, 2023, compared to $45 thousand for the
same period in 2022. The increase is primarily related to higher
direct labor costs due to an increase in research activities
performed under customer contracts.
R&D expenses totaled $344 thousand for the three months
ended March 31, 2023, compared to $487 thousand for the same period
in 2022. The overall decrease of approximately $143 thousand is
primarily related to lower lab supply expenses and a greater
allocation of resources to cost of revenue in the three months
ended March 31, 2023.
General and administrative expenses totaled $2.4
million for the three months ended March 31, 2023, compared to $2.0
million for the same period in 2022, due primarily to an increase
in expenses in connection with the Company’s growth and costs
associated with operating a public company, including an
incremental $256 thousand of non-cash stock compensation
expense.
Comera reported a net loss of $2.6 million, or
$0.13 loss per share for the three months ended March 31, 2023,
compared to a net loss of $2.9 million, or $4.01 loss per share,
for the same period in 2022. The decrease was primarily due to
higher non-operating expense in the prior year.
Comera had $1.6 million in cash, cash
equivalents and restricted cash at March 31, 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
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) |
|
|
|
March 31, |
|
December
31, |
|
|
|
|
2023 |
|
|
|
2022 |
|
|
Assets |
|
|
|
|
|
Current
assets: |
|
|
|
|
|
Cash and cash equivalents |
|
$ |
1,538,653 |
|
|
$ |
446,607 |
|
|
Restricted cash - current |
|
|
— |
|
|
|
1,505,625 |
|
|
Accounts receivable |
|
|
— |
|
|
|
34,320 |
|
|
Deferred issuance costs |
|
|
— |
|
|
|
90,047 |
|
|
Prepaid expenses and other current assets |
|
|
868,784 |
|
|
|
986,499 |
|
|
Total current assets |
|
|
2,407,437 |
|
|
|
3,063,098 |
|
|
Restricted
cash - non-current |
|
|
50,000 |
|
|
|
50,000 |
|
|
Property and
equipment, net |
|
|
234,576 |
|
|
|
257,186 |
|
|
Right-of-use
asset |
|
|
263,904 |
|
|
|
313,629 |
|
|
Security
deposit |
|
|
43,200 |
|
|
|
43,200 |
|
|
Total assets |
|
$ |
2,999,117 |
|
|
$ |
3,727,113 |
|
|
Liabilities, Convertible Preferred Stock and Stockholders’
Deficit |
|
|
|
|
|
Current
liabilities: |
|
|
|
|
|
Accounts payable |
|
$ |
1,772,187 |
|
|
$ |
1,458,267 |
|
|
Accrued expenses and other current liabilities |
|
|
1,365,334 |
|
|
|
1,295,764 |
|
|
Insurance premium financing |
|
|
— |
|
|
|
455,562 |
|
|
Deposit liability |
|
|
— |
|
|
|
1,505,625 |
|
|
Deferred revenue |
|
|
— |
|
|
|
144,280 |
|
|
Lease liability - current |
|
|
217,500 |
|
|
|
199,184 |
|
|
Total current liabilities |
|
|
3,355,021 |
|
|
|
5,058,682 |
|
|
Derivative
warrant liabilities |
|
|
250,745 |
|
|
|
277,507 |
|
|
Lease
liability - noncurrent |
|
|
53,669 |
|
|
|
120,302 |
|
|
Total liabilities |
|
|
3,659,435 |
|
|
|
5,456,491 |
|
|
Commitments
and contingencies (Note 15) |
|
|
|
|
|
Series A
convertible preferred stock |
|
|
4,604,526 |
|
|
|
4,517,710 |
|
|
Stockholders’ equity (deficit): |
|
|
|
|
|
Common stock, $0.0001 par value; 150,000,000 shares authorized;
19,152,693 and 16,709,221 shares issued and outstanding at March
31, 2023 and December 31, 2022, respectively |
|
|
1,915 |
|
|
|
1,671 |
|
|
Additional paid-in capital |
|
|
32,118,476 |
|
|
|
28,655,164 |
|
|
Accumulated deficit |
|
|
(37,385,235 |
) |
|
|
(34,903,923 |
) |
|
Total stockholders’ deficit |
|
|
(5,264,844 |
) |
|
|
(6,247,088 |
) |
|
Total liabilities, convertible preferred stock and stockholders’
deficit |
|
$ |
2,999,117 |
|
|
$ |
3,727,113 |
|
|
|
|
|
|
|
|
COMERA LIFE
SCIENCES HOLDINGS, INC. |
CONSOLIDATED STATEMENTS OF OPERATIONS AND
COMPREHENSIVE LOSS |
(unaudited) |
|
|
|
Three Months Ended March 31, |
|
|
|
|
2023 |
|
|
|
2022 |
|
|
Revenue |
|
$ |
392,915 |
|
|
$ |
95,334 |
|
|
Cost of
revenue |
|
|
116,519 |
|
|
|
44,524 |
|
|
Operating
expenses: |
|
|
|
|
|
Research and development |
|
|
343,705 |
|
|
|
487,217 |
|
|
General and administrative |
|
|
2,433,147 |
|
|
|
2,016,245 |
|
|
Total operating expenses |
|
|
2,776,852 |
|
|
|
2,503,462 |
|
|
Loss from
operations |
|
|
(2,500,456 |
) |
|
|
(2,452,652 |
) |
|
Other income
(expense), net: |
|
|
|
|
|
Change in fair value of derivative warrant liabilities |
|
|
26,762 |
|
|
|
— |
|
|
Interest expense |
|
|
(7,618 |
) |
|
|
(77 |
) |
|
Other expense, net |
|
|
— |
|
|
|
(426,666 |
) |
|
Total other income (expense), net |
|
|
19,144 |
|
|
|
(426,743 |
) |
|
Net loss and
comprehensive loss |
|
|
(2,481,312 |
) |
|
|
(2,879,395 |
) |
|
Less:
accretion of convertible preferred stock to redemption value |
|
|
(86,816 |
) |
|
|
— |
|
|
Net loss
attributable to common stockholders |
|
$ |
(2,568,128 |
) |
|
$ |
(2,879,395 |
) |
|
Net loss per
share attributable to common stockholders — basic and diluted |
|
$ |
(0.13 |
) |
|
$ |
(4.01 |
) |
|
Weighted-average number of common shares used in computing net loss
per share attributable to common stockholders — basic and
diluted |
|
|
19,033,436 |
|
|
|
718,419 |
|
|
|
|
|
|
|
|
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