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 quarter ended September 30, 2022
and provided a business update.
“We are extremely pleased with our progress this
quarter. We have made significant advancements in strengthening our
internal pipeline, team and capabilities, highlighted by a recent
extension and expansion of one of our noteworthy biotechnology
partnerships,” said Jeffrey Hackman, Chairman and Chief Executive
Officer of Comera. “We continue to execute on our long-term
strategy to leverage our SQore™ platform to transform the delivery
of biologics from intravenous to subcutaneous form, and achieve our
mission of reducing healthcare costs and improving patient quality
of life by offering treatments that support greater independence
while also creating value for our shareholders.”
3Q 2022 and Recent Business Highlights
- Recently,
Comera extended and broadened its ongoing research collaboration
with Regeneron, a leading U.S. biotechnology company. The
partnership includes a right to negotiate a license after further
technical evaluation is complete.
- Today, Comera
is introducing its lead pipeline candidate CLS-001 as a
subcutaneous (SQ) formulation of vedolizumab, a currently marketed
product for the treatment of IBD including Crohn’s disease and
ulcerative colitis. Comera believes that a SQ formulation of
vedolizumab could have significant advantages for patients and the
healthcare system, compared to the current intravenous (IV)
formulation.
- In July 2022,
Comera announced favorable topline results from its SEQURUS-1
study. The results of this preclinical study provide supportive
evidence of safety of Comera’s lead caffeine-based SQore excipient
when administered as a SQ biologic drug product formulation with a
monoclonal antibody (mAb). SEQURUS-1 demonstrated no evidence of
local or systemic toxicity of caffeine when administered
subcutaneously with ipilimumab, a mAb therapy that works to
activate the immune system by targeting CTLA-4 to treat melanoma,
in animals. Furthermore, a rapid clearance of caffeine was seen
within eight hours from test animals, in line with modeled
predictions. Initial data also demonstrate no evidence of caffeine
impact on ipilimumab absorption.
- In August
2022, Comera announced entry into a purchase agreement with Arena
Business Solutions Global SPC II, Ltd. (Arena) for up to $15
million of the Company’s common stock, with an option to increase
to $30 million. The equity line of credit will be used to invest in
Comera’s pipeline and proprietary SQore platform. Comera has the
right to sell to Arena up to $15 million worth of shares, in its
sole discretion, over a 36-month period subject to certain
limitations.
- In October
2022, Comera announced the expansion of its Woburn, Mass. facility.
The expanded facility spans over 5,000 square feet and includes
additional laboratory space for research and development (R&D)
activities as well as new executive offices. The increased
footprint will allow the company to double its workforce in the
coming years.
- In October
2022, Comera announced favorable safety and pharmacokinetic results
from its SEQURUS-2 study. Together with the SEQURUS-1 study, the
SEQURUS-2 data demonstrate no evidence of local or systemic
toxicity of caffeine in animals when administered subcutaneously
with ipilimumab. Additionally, the results establish that caffeine
had no impact on ipilimumab half-life and no effect on
pharmacokinetic data for both the IV and SQ groups.
- In November
2022, Comera appointed Janice Marie McCourt as Chief Business
Officer. In her role at Comera, Ms. McCourt will be responsible for
business development, including evaluation and execution of
out-licensing, in-licensing and strategic transaction
opportunities, and driving the execution of the Company’s
commercial strategy. Ms. McCourt brings more than 30 years of
biotechnology and pharmaceutical experience.
Third Quarter 2022 Financial Results
Comera reported revenues of $235 thousand for
the three months ended September 30, 2022, compared to $88 thousand
for the same period in 2021, with the increase primarily related to
an increase in research activities performed under customer
contracts.
Cost of revenue totaled $61 thousand for the
three months ended September 30, 2022, compared to $48 thousand for
the same period in 2021.
R&D expenses totaled $395 thousand for the
three months ended September 30, 2022, compared to $264 thousand
for the same period in 2021, with the increase primarily related to
expansion of R&D activities and higher employee related
expenses.
General and administrative expenses totaled $2.3
million for the three months ended September 30, 2022, compared to
$689 thousand for the same period in 2021, due primarily to an
increase in expenses in connection with the Company’s growth and
costs associated with transitioning to a public company.
Comera reported a net loss attributable to
common stockholders of $3.2 million, or $0.20 loss per share for
the three months ended September 30, 2022, primarily driven by
increased expenses to support the Company’s growth and public
company related costs, as compared to a net loss of $914 thousand,
or $6.34 loss per share, for the same period in
2021.
Comera had $3.0 million in cash and receivables
at September 30, 2022.
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: risks that the recently completed business combination
disrupts the Company’s current plans and ability to retain its
employees; the Company’s ability to maintain the listing of its
securities on the Nasdaq Capital Market; the effect of the COVID-19
pandemic on the Company’s business; 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
ability to implement business plans, forecasts, and other
expectations and identify and realize additional opportunities; the
risk of 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; general economic conditions;
and other risks and uncertainties indicated in the Current Report
on Form 8-K filed with the SEC on May 25, 2022 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. You should
carefully consider the foregoing factors and the other risks and
uncertainties described in the “Risk Factors” section of Comera’s
Current Report on Form 8-K filed with the SEC on May 25, 2022 and
other documents filed by Comera from time to time with the SEC.
These filings identify and address other important risks and
uncertainties that could cause actual events and results to differ
materially from those contained in the forward-looking statements.
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.BALANCE
SHEETS(unaudited)
|
September
30, |
|
December
31, |
|
2022 |
|
|
2021 |
|
Assets |
|
|
|
Current
assets: |
|
|
|
Cash and cash equivalents |
$ |
2,669,354 |
|
|
$ |
6,510,140 |
|
Accounts
receivable |
|
293,821 |
|
|
|
– |
|
Due from
related parties |
|
– |
|
|
|
286 |
|
Prepaid
expenses and other current assets |
|
1,325,753 |
|
|
|
270,648 |
|
Total
current assets |
|
4,288,928 |
|
|
|
6,781,074 |
|
Restricted
cash |
|
50,000 |
|
|
|
50,000 |
|
Property and
equipment, net |
|
192,590 |
|
|
|
234,167 |
|
Right of use
asset |
|
362,401 |
|
|
|
320,373 |
|
Security
deposit |
|
43,200 |
|
|
|
32,200 |
|
Total
assets |
$ |
4,937,119 |
|
|
$ |
7,417,814 |
|
Liabilities, Convertible Preferred Stock and Stockholders'
Deficit |
|
|
|
Current
liabilities: |
|
|
|
Accounts
payable |
$ |
1,436,692 |
|
|
$ |
416,941 |
|
Accrued
expenses and other current liabilities |
|
887,012 |
|
|
|
506,611 |
|
Insurance
premium financing |
|
911,124 |
|
|
|
– |
|
Lease
liability - current |
|
195,253 |
|
|
|
121,552 |
|
Total
current liabilities |
|
3,430,081 |
|
|
|
1,045,104 |
|
Derivative
warrant liabilities |
|
331,612 |
|
|
|
– |
|
Lease
liability - noncurrent |
|
171,596 |
|
|
|
201,504 |
|
Total
liabilities |
|
3,933,289 |
|
|
|
1,246,608 |
|
Commitments
and contingencies |
|
|
|
Series A
convertible preferred stock |
|
4,431,838 |
|
|
|
– |
|
Convertible
preferred stock |
|
– |
|
|
|
20,857,453 |
|
Stockholders' equity (deficit): |
|
|
|
Common
stock, $0.0001 par value; 150,000,000 shares authorized; 16,653,466
and 308,443 shares issued and outstanding at September 30, 2022 and
December 31, 2021, respectively |
|
1,665 |
|
|
|
31 |
|
Additional
paid-in capital |
|
28,511,656 |
|
|
|
2,213,547 |
|
Accumulated
deficit |
|
(31,941,329 |
) |
|
|
(16,899,825 |
) |
Total
stockholders' deficit |
|
(3,428,008 |
) |
|
|
(14,686,247 |
) |
Total
liabilities, convertible preferred stock and stockholders'
deficit |
$ |
4,937,119 |
|
|
$ |
7,417,814 |
|
|
|
|
|
|
|
COMERA LIFE SCIENCES HOLDINGS,
INC.STATEMENTS OF OPERATIONS AND COMPREHENSIVE
LOSS (unaudited)
|
Three Months Ended September 30, |
|
Nine Months Ended September 30, |
|
2022 |
|
|
2021 |
|
|
2022 |
|
|
2021 |
|
Revenue |
$ |
234,922 |
|
|
$ |
87,767 |
|
|
$ |
476,982 |
|
|
$ |
246,498 |
|
Cost of
revenue |
|
60,963 |
|
|
|
48,364 |
|
|
|
160,030 |
|
|
|
122,073 |
|
Operating
expenses: |
|
|
|
|
|
|
|
Research and
development |
|
394,800 |
|
|
|
263,620 |
|
|
|
1,250,570 |
|
|
|
1,262,329 |
|
General and
administrative |
|
2,314,554 |
|
|
|
689,483 |
|
|
|
8,027,316 |
|
|
|
2,373,621 |
|
Total
operating expenses |
|
2,709,354 |
|
|
|
953,103 |
|
|
|
9,277,886 |
|
|
|
3,635,950 |
|
Loss from
operations |
|
(2,535,395 |
) |
|
|
(913,700 |
) |
|
|
(8,960,934 |
) |
|
|
(3,511,525 |
) |
Other income
(expense), net: |
|
|
|
|
|
|
|
Change in
fair value of derivative warrant liabilities |
|
500,327 |
|
|
|
– |
|
|
|
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 |
) |
|
|
– |
|
Gain on debt
extinguishment |
|
– |
|
|
|
– |
|
|
|
– |
|
|
|
160,588 |
|
Change in
fair value of convertible notes |
|
– |
|
|
|
– |
|
|
|
– |
|
|
|
(76,738 |
) |
Interest
expense |
|
(12,696 |
) |
|
|
– |
|
|
|
(12,773 |
) |
|
|
– |
|
Other
expense, net |
|
– |
|
|
|
– |
|
|
|
(426,666 |
) |
|
|
– |
|
Total other
(expense) income, net |
|
(541,446 |
) |
|
|
– |
|
|
|
(6,080,570 |
) |
|
|
83,850 |
|
Net loss and
comprehensive loss |
|
(3,076,841 |
) |
|
|
(913,700 |
) |
|
|
(15,041,504 |
) |
|
|
(3,427,675 |
) |
Less:
accretion of convertible preferred stock to redemption value |
|
(86,816 |
) |
|
|
– |
|
|
|
(287,984 |
) |
|
|
– |
|
Net loss
attributable to common stockholders or unit holders |
$ |
(3,163,657 |
) |
|
$ |
(913,700 |
) |
|
$ |
(15,329,488 |
) |
|
$ |
(3,427,675 |
) |
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