– Significant progress in Comera’s ongoing research collaboration with Regeneron, a leading
– Further development of Comera’s pipeline candidate CLS-001 (SQ vedolizumab), highlighted by identification of a lead formulation –
– Expanded Comera’s patent portfolio, broadening geographic coverage as well as scope of claims for core SQore™ excipient technology –
“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
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 ofthe 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 inSouth Korea and two Notices of Allowance inthe United States andJapan 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
Cost of revenue totaled
R&D expenses totaled
General and administrative expenses totaled
Comera reported a net loss of
Comera had
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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
Contacts
Comera Investor
ICR Westwicke
John.Woolford@westwicke.com
ICR Westwicke
ComeraPR@westwicke.com
CONSOLIDATED BALANCE SHEETS | |||||||||
(unaudited) | |||||||||
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, | 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 | |||||
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS | |||||||||
(unaudited) | |||||||||
Three Months Ended | |||||||||
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 | |||||||
Source:
2023 GlobeNewswire, Inc., source