o
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, DC 20549
FORM
(Mark One)
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the quarterly period ended
OR
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the transition period from ___________________ to ___________________
Commission File Number:
(Exact Name of Registrant as Specified in its Charter)
(State or other jurisdiction of incorporation or organization) |
(I.R.S. Employer |
(Address of principal executive offices) |
(Zip Code) |
(
(Registrant’s telephone number, including area code)
Not Applicable
(Former name, former address and former fiscal year, if changed since last report)
Securities registered pursuant to Section 12(b) of the Act:
Title of each class |
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Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.
Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files).
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
Large accelerated filer |
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Accelerated filer |
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Smaller reporting company |
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Emerging growth company |
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If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No
As of May 11, 2023, the registrant had
Table of Contents
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PART I. |
3 |
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Item 1. |
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Consolidated Balance Sheets as of March 31, 2023 and December 31, 2022 (unaudited) |
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Consolidated Statements of Cash Flows for the Three Months Ended March 31, 2023 and 2022 (unaudited) |
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Notes to Condensed Consolidated Financial Statements (unaudited) |
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Item 2. |
Management’s Discussion and Analysis of Financial Condition and Results of Operations |
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Item 3. |
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Item 4. |
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PART II. |
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Item 1. |
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Item 1A. |
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Item 2. |
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Item 3. |
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Item 4. |
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Item 5. |
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Item 6. |
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2
PART I—FINANCIAL INFORMATION
Item 1. Financial Statements.
COMERA LIFE SCIENCES HOLDINGS, INC.
CONSOLIDATED BALANCE SHEETS
(unaudited)
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March 31, |
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December 31, |
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2023 |
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2022 |
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Assets |
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Current assets: |
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Cash and cash equivalents |
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$ |
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$ |
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Restricted cash - current |
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— |
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Accounts receivable |
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— |
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Deferred issuance costs |
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— |
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Prepaid expenses and other current assets |
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Total current assets |
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Restricted cash - non-current |
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Property and equipment, net |
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Right-of-use asset |
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Security deposit |
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Total assets |
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$ |
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$ |
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Liabilities, Convertible Preferred Stock and Stockholders’ Deficit |
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Current liabilities: |
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Accounts payable |
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$ |
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$ |
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Accrued expenses and other current liabilities |
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Insurance premium financing |
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— |
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Deposit liability |
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— |
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Deferred revenue |
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— |
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Lease liability - current |
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Total current liabilities |
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Derivative warrant liabilities |
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Lease liability - noncurrent |
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Total liabilities |
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Preferred stock, $ |
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Stockholders’ equity (deficit): |
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Common stock, $ |
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Additional paid-in capital |
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Accumulated deficit |
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( |
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( |
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Total stockholders’ deficit |
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( |
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( |
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Total liabilities, convertible preferred stock and stockholders’ deficit |
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$ |
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$ |
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The accompanying notes are an integral part of these condensed consolidated financial statements.
3
COMERA LIFE SCIENCES HOLDINGS, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(unaudited)
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Three Months Ended March 31, |
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2023 |
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2022 |
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Revenue |
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$ |
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$ |
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Cost of revenue |
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Operating expenses: |
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Research and development |
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General and administrative |
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Total operating expenses |
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Loss from operations |
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( |
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Other income (expense), net: |
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Change in fair value of derivative warrant liabilities |
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— |
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Interest expense |
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( |
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( |
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Other expense, net |
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— |
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( |
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Total other income (expense), net |
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( |
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Net loss and comprehensive loss |
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( |
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Less: accretion of convertible preferred |
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( |
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— |
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Net loss attributable to common stockholders |
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$ |
( |
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$ |
( |
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Net loss per share attributable to common stockholders — basic and diluted |
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$ |
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$ |
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Weighted-average number of common shares used in computing net loss |
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The accompanying notes are an integral part of these condensed consolidated financial statements.
4
COMERA LIFE SCIENCES HOLDINGS, INC.
CONSOLIDATED STATEMENTS OF CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS’ DEFICIT
(unaudited)
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Series A Convertible |
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Convertible |
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Additional |
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Preferred Stock |
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Preferred Stock |
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Common Stock |
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Paid-in |
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Accumulated |
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Total |
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Shares |
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Amount |
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Shares |
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Amount |
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Shares |
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Amount |
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Capital |
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Deficit |
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Stockholders’ Deficit |
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Balance as of December 31, 2022 |
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$ |
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— |
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$ |
— |
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$ |
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$ |
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$ |
( |
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$ |
( |
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Issuance of common stock in connection with the January 2023 PIPE, net of issuance costs |
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Issuance of common stock in connection with the Arena purchase agreement |
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— |
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— |
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— |
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— |
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— |
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Accretion of convertible preferred stock to redemption value |
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— |
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— |
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— |
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— |
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— |
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( |
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— |
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( |
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Stock-based compensation expense |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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Net loss |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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( |
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Balance as of March 31, 2023 |
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$ |
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— |
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$ |
- |
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$ |
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$ |
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$ |
( |
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$ |
( |
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Series A Convertible |
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Convertible |
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Additional |
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Preferred Stock |
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Preferred Stock |
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Common Stock |
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Paid-in |
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Accumulated |
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Total |
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Shares |
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Amount |
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Shares |
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Amount |
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Shares |
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Amount |
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Capital |
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Deficit |
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Stockholders’ Deficit |
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Balance as of December 31, 2021 |
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— |
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$ |
— |
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$ |
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$ |
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$ |
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$ |
( |
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$ |
( |
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Issuance of common stock upon exercise of stock options |
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— |
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— |
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— |
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— |
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— |
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Stock-based compensation expense |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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Net loss |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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( |
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( |
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Balance as of March 31, 2022 |
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— |
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$ |
— |
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$ |
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$ |
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$ |
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$ |
( |
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$ |
( |
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The accompanying notes are an integral part of these condensed consolidated financial statements.
5
COMERA LIFE SCIENCES HOLDINGS, INC.
CONSOLIDATED STATEMENTS OF CASH FLOWS
(unaudited)
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Three Months Ended March 31, |
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2023 |
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2022 |
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Cash flows from operating activities: |
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Net loss |
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$ |
( |
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$ |
( |
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Adjustments to reconcile net loss to net cash used in operating activities: |
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Stock-based compensation expense |
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Depreciation expense |
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Noncash lease expense |
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( |
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Change in fair value of derivative warrant liabilities |
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( |
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— |
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Changes in operating assets and liabilities: |
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Accounts receivable |
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( |
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Prepaid expenses and other current assets |
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Due from related parties |
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— |
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Accounts payable |
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Accrued expenses and other current liabilities |
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( |
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Deferred revenue |
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Net cash used in operating activities |
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( |
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Cash flows from investing activities: |
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Purchases of property and equipment |
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( |
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— |
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Net cash flows used in investing activities |
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( |
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— |
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Cash flows from financing activities: |
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Deferred offering costs paid in cash |
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— |
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( |
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Proceeds from January 2023 PIPE, net of issuance costs |
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— |
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Proceeds from the Arena Purchase Agreement |
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— |
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Repayment of insurance premium financing |
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( |
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— |
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Proceeds from exercise of stock options |
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— |
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Net cash provided by financing activities |
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Net decrease in cash, cash equivalents and restricted cash |
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( |
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( |
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Cash, cash equivalents and restricted cash at beginning of period |
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Cash, cash equivalents, and restricted cash at end of period |
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$ |
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$ |
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Supplemental information: |
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Cash and cash equivalents |
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$ |
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$ |
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Restricted cash |
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Total cash, cash equivalents, and restricted cash shown in statements of cash flows |
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$ |
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$ |
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Supplemental disclosure of noncash investing and financing activities: |
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Fixed asset additions in accounts payable |
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$ |
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$ |
— |
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Stock issuance costs in accounts payable and accrued expenses and other current liabilities |
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$ |
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$ |
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Issuance of common stock in exchange for services by the Company's Board of Directors |
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$ |
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$ |
— |
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Accretion on convertible preferred stock |
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$ |
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$ |
— |
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The accompanying notes are an integral part of these condensed consolidated financial statements.
6
COMERA LIFE SCIENCES HOLDINGS, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
1. Organization
Formation and Organization
Comera Life Sciences Holdings, Inc. (“CLS Holdings,” “Comera” or the “Company”) was incorporated in Delaware on
Legacy Comera was formed in the state of Delaware on January 2, 2014 as ReForm Biologics, LLC. On April 30, 2021, Legacy Comera completed a corporate reorganization (the “Reorganization”) and changed its name to ReForm Biologics, Inc. As part of the Reorganization, each issued and outstanding capital unit of Legacy Comera as of the date of the Reorganization was exchanged for shares of convertible preferred stock of Legacy Comera and previously outstanding incentive units of Legacy Comera were cancelled. On January 7, 2022, Legacy Comera changed its name to Comera Life Sciences, Inc. to emphasize Comera’s vision of a compassionate new era in medicine. On May 19, 2022, in connection with the closing of the Transaction, Legacy Comera became a wholly-owned subsidiary of CLS Holdings.
Comera is a biotechnology company dedicated to promoting a compassionate new era in medicine. The Company applies a deep knowledge of formulation science and technology to transform essential biologic medicines from intravenous (“IV”) to subcutaneous (“SQ”) forms. This revolutionary technology provides patients and families with the freedom of self-injectable care, allowing them to realize the potential of these life changing therapies, and to unlock the vast potential of their own lives. To accomplish this, Comera is developing an internal portfolio of proprietary therapeutics that incorporate Comera’s innovative proprietary formulation platform, SQore. Comera also collaborates with pharmaceutical and biotechnology companies, applying the SQore platform to Comera’s partners’ biologic medicines to deliver enhanced formulations that facilitate self-injectable care.
Transaction
On
The Transaction was accounted for as a reverse recapitalization because Legacy Comera has been determined to be the accounting acquirer. Under the reverse recapitalization model, the Transaction treated Legacy Comera as issuing equity for the net assets of OTR, with
2. Basis of Presentation and Significant Accounting Policies
Basis of Presentation
The accompanying condensed consolidated financial statements have been prepared pursuant to the rules and regulations of the Securities and Exchange Commission (the “SEC”) and in conformity with accounting principles generally accepted in the United States of America (“GAAP”). Any reference in these notes to applicable guidance is meant to refer to the authoritative United States generally accepted accounting principles as found in the Accounting Standards Codification (“ASC”) and Accounting Standards Updates (“ASU”) of the Financial Accounting Standards Board (“FASB”).
The condensed consolidated financial statements do not include all the information and footnotes required by GAAP for complete financial statements and should be read in conjunction with the Company’s consolidated financial statements and related notes for the years ended December 31, 2022 and 2021 included in the Form 10-K filed with the SEC on March 17, 2023 (the “2022 Annual Report”).
7
The financial information as of March 31, 2023, and for the three months ended March 31, 2023 and 2022, is unaudited. In the opinion of management, all adjustments, consisting only of normal recurring adjustments considered necessary for the fair presentation of financial position, results of operations, and cash flows at the dates and for the periods presented, have been included. The balance sheet data as of December 31, 2022 was derived from audited consolidated financial statements. The results of the Company’s operations for any interim periods are not necessarily indicative of the results that may be expected for any other interim period or for a full fiscal year.
Risks and Uncertainties
The Company is subject to risks and uncertainties common to early-stage companies in the biotechnology industry, including but not limited to, risks associated with completing preclinical studies and clinical trials, receiving regulatory approvals for product candidates, development by competitors of new biopharmaceutical products, dependence on key personnel, protection of proprietary technology, compliance with government regulations and the ability to secure additional capital to fund operations. Significant discovery, research and development efforts, including clinical testing and regulatory approval, are required prior to commercialization of any potential product candidates. These efforts require significant amounts of additional capital, adequate personnel and infrastructure and extensive compliance-reporting capabilities. Even if the Company’s product development efforts are successful, it is uncertain when, if ever, the Company will realize revenue from product sales.
Through March 31, 2023, the Company has funded its operations primarily with proceeds from the issuance of equity instruments and convertible notes. The Company has incurred recurring losses since its inception, including a net loss of $
The Company does not believe the cash, cash equivalents, and restricted cash on hand as of March 31, 2023 of $
Use of Estimates
The preparation of financial statements in accordance with GAAP requires management to make estimates and assumptions, based on judgments considered reasonable, which affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of expenses during the reporting periods. The Company bases its estimates and assumptions on historical experience, known trends and events and various other factors that management believes to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not readily apparent from other sources. Significant estimates and assumptions reflected in these condensed consolidated financial statements include, but are not limited to, the valuation of derivative warrant liabilities, valuation of earn-out shares, and revenue recognition. Changes in estimates are recorded in the period in which they become known. Due to the risks and uncertainties involved in the Company’s business and evolving market conditions and, given the subjective element of the estimates and assumptions made, actual results may differ from estimated results.
Summary of Significant Accounting Policies
The significant accounting policies of the Company are set forth in Note 2, Basis of Presentation and Significant Accounting Policies, of the consolidated financial statements included in the 2022 Annual Report. During the three months ended March 31, 2023, the Company did not make any changes to its significant accounting policies.
8
Recently Issued Accounting Pronouncements
From time to time, new accounting pronouncements are issued by the FASB or other standard setting bodies and adopted by us as of the specified effective date. Unless otherwise discussed, the Company believes that the impact of recently issued standards that are not yet effective will not have a material impact on the Company’s consolidated financial statements and disclosures.
3. Fair Value of Financial Assets and Liabilities
The following table presents the Company’s fair value hierarchy for its liabilities, which are measured at fair value on a recurring basis as of March 31, 2023:
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Fair Value Measurements at March 31, 2023 Using: |
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Level 1 |
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Level 2 |
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Level 3 |
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Total |
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Liabilities: |
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Derivative warrant liabilities |
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$ |
— |
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$ |
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$ |
— |
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$ |
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Fair Value Measurements at December 31, 2022 Using: |
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Level 1 |
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Level 2 |
|
|
Level 3 |
|
|
Total |
|
||||
Liabilities: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Derivative warrant liabilities |
|
$ |
— |
|
|
$ |
|
|
$ |
— |
|
|
$ |
|
||
|
|
|
|
|
|
|
|
|
|
|
|
|
There were no assets for which fair value was required to be disclosed as of March 31, 2023 or December 31, 2022. During the three months ended March 31, 2023, there were no transfers between Level 1, Level 2 and Level 3.
4. Prepaid Expenses and Other Current Assets
Prepaid expenses and other current assets consisted of the following:
|
|
March 31, |
|
|
December 31, |
|
||
Prepaid insurance |
|
$ |
|
|
$ |
|
||
Contract assets |
|
|
|
|
|
— |
|
|
Other |
|
|
|
|
|
|
||
Prepaid expenses and other current assets |
|
$ |
|
|
$ |
|
5. Property and Equipment, Net
Property and equipment, net consisted of the following:
|
|
March 31, |
|
|
December 31, |
|
||
Lab equipment |
|
$ |
|
|
$ |
|
||
Leasehold improvements |
|
|
|
|
|
|
||
Computer equipment |
|
|
|
|
|
|
||
Other equipment |
|
|
|
|
|
|
||
Construction in progress |
|
|
|
|
|
|
||
|
|
|
|
|
|
|
||
Less accumulated depreciation |
|
|
( |
) |
|
|
( |
) |
Property and equipment, net |
|
$ |
|
|
$ |
|
Depreciation expense for the three months ended March 31, 2023 and 2022 was $
9
6. Accrued Expenses and Other Current Liabilities
Accrued expenses and other current liabilities consisted of the following:
|
|
March 31, |
|
|
December 31, |
|
||
Accrued bonus |
|
$ |
|
|
$ |
|
||
Professional fees |
|
|
|
|
|
|
||
Accrued vacation |
|
|
|
|
|
|
||
Other |
|
|
|
|
|
|
||
Accrued expenses and other current liabilities |
|
$ |
|
|
$ |
|
7. Insurance Premium Financing
In May 2022, the Company entered into a finance agreement with First Insurance Funding in order to fund a portion of its insurance policies. The amount financed was $
8. Convertible Preferred Stock
As of March 31, 2023, the Company’s amended and restated certificate of incorporation (the “Articles”) provides for a class of authorized stock known as preferred stock, consisting of
Convertible preferred stock consisted of the following as of March 31, 2023:
|
|
Par Value |
|
|
Shares Authorized |
|
|
Shares Issued and |
|
|
Carrying Value |
|
|
Liquidation |
|
|
Common Stock |
|
||||||
Series A Preferred Stock |
|
$ |
|
|
|
|
|
|
|
|
$ |
|
|
$ |
|
|
|
|
In May 2022, the Company issued
As the preferred stock is considered to be contingently redeemable, the preferred stock has been classified outside of permanent equity. Since the contingent redemption is considered probable, the Series A Preferred Stock will be accreted to its redemption value at each reporting date. The Company recorded accretion of $
9
As of March 31, 2023, the authorized capital stock of the Company included
10
Each share of common stock entitles the holder to
As of March 31, 2023, the Company has reserved the following shares of common stock for future issuance:
Exercise of outstanding stock options |
|
|
|
|
Available for issuance under equity compensation plans |
|
|
|
|
Exercise of outstanding common stock warrants |
|
|
|
|
Conversion of Series A Preferred Stock |
|
|
|
|
Reserved for issuance pursuant to the Arena Purchase Agreement |
|
|
|
|
Total shares of authorized common stock reserved for future issuance |
|
|
|
January 2023 PIPE
On January 2, 2023, the Company entered into a securities purchase agreement (the “Securities Purchase Agreement”) with a select group of existing shareholders and members of the Company's board of directors (the “Purchasers”), pursuant to which the Company agreed to issue and sell to the Purchasers in a private placement (the “January 2023 PIPE”) an aggregate of
The following table reconciles the gross proceeds received from the January 2023 PIPE to the statement of cash flows:
Total gross proceeds |
|
|
|
|
Advanced deposits received in FY22 |
|
|
( |
) |
Non-cash proceeds related to board compensation |
|
|
( |
) |
Issuance costs paid in cash |
|
|
( |
) |
FY23 cash proceeds from January 2023 PIPE, net of issuance costs |
|
|
|
Common Stock Purchase Agreement
On August 31, 2022, the Company entered into a purchase agreement (the “Arena Purchase Agreement”) with Arena Business Solutions Global SPC II, Ltd. (“Arena”), pursuant to which Arena has committed to purchase up to $
The Company determined that its right to sell shares of the Company’s common stock to Arena represents a freestanding put option under ASC 815, but has a fair value of zero, and therefore no additional accounting was required. The Company issued
During the three months ended March 31, 2023, the Company sold
11
10. Stock-Based Compensation
2021 Stock Option and Grant Plan
On April 30, 2021, Legacy Comera established the 2021 Stock Option and Grant Plan (the “2021 Plan”), which provided for the grant of incentive stock options, non-statutory stock options, restricted stock awards, unrestricted stock awards and restricted stock units. In connection with the closing of the Transaction, option awards outstanding under the 2021 Plan were exchanged for options to purchase shares of the Company's common stock (the “Exchanged Options”), with proportional adjustments to the number of shares underlying the options and the exercise price of the options approved by the compensation committee and board of directors of Legacy Comera. Other than with respect to the exercise price and the underlying number of shares of the Company's common stock, the Exchanged Options remain subject to the terms and conditions of the Legacy Comera option awards issued pursuant to the 2021 Plan. The Exchanged Options are outstanding under and count against the number of shares reserved for issuance pursuant to the 2022 Equity and Incentive Plan (the “2022 Plan”). Following the closing of the Transaction, no additional awards may be granted under the 2021 Plan.
As of March 31, 2023, there were
2022 Equity and Incentive Plan
On May 10, 2022, the Company established the 2022 Plan, which provides for the grant of incentive stock options, non-statutory stock options, restricted stock awards, unrestricted stock awards, restricted stock units, stock appreciation rights, cash awards and dividend equivalent rights. Incentive stock options may be granted only to the Company’s employees, including officers. Non-statutory options, restricted stock awards, unrestricted stock awards, restricted stock units, stock appreciation rights, cash awards and dividend equivalent rights may be granted to employees, directors, consultants and key persons of the Company.
The total number of common shares authorized to be issued under the 2022 Plan was
Shares underlying awards that are forfeited, cancelled, reacquired by the Company prior to vesting, satisfied without the issuance of common stock, or are otherwise terminated under the 2022 Plan without having been fully exercised (including the Exchanged Options) will be available for future awards.
Stock Option Activity
The following table summarizes the Company’s stock option activity for the three months ended March 31, 2023:
|
|
Number of |
|
|
Weighted- |
|
|
Weighted- |
|
|
Aggregate |
|
||||
Outstanding as of December 31, 2022 |
|
|
|
|
$ |
|
|
|
|
$ |
|
|||||
Granted |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Cancelled or forfeited |
|
|
( |
) |
|
|
|
|
|
|
|
|
|
|||
Outstanding as of March 31, 2023 |
|
|
|
|
$ |
|
|
|
|
|
$ |
|
||||
Exercisable as of March 31, 2023 |
|
|
|
|
$ |
|
|
|
|
|
$ |
|
The aggregate intrinsic value of stock options is calculated as the difference between the exercise price of the underlying stock options and the estimated fair value of the Company’s common stock for those stock options that had exercise prices lower than the estimated fair value of the Company’s common stock.
The weighted-average grant date fair value of options granted during the three months ended March 31, 2023 was $
12
As of March 31, 2023, total unrecognized compensation cost related to the unvested stock options was $
Stock-Based Compensation
Stock-based compensation expense was allocated as follows:
|
|
Three Months Ended March 31, |
|
|||||
|
|
2023 |
|
|
2022 |
|
||
Cost of revenue |
|
$ |
|
|
$ |
|
||
Research and development |
|
|
|
|
|
|
||
General and administrative |
|
|
|
|
|
|
||
Total stock-based compensation |
|
$ |
|
|
$ |
|
11. Common Stock Warrants
During the three months ended March 31, 2023, there were
The following represents a summary of the warrants outstanding and exercisable at March 31, 2023:
|
|
|
|
|
|
|
|
|
|
|
Number of Shares Underlying Warrants |
|
||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||
Description |
|
Issue Date |
|
Classification |
|
Exercise Price |
|
|
Expiration Date |
|
Outstanding Shares |
|
|
Exercisable Shares |
|
|||
2020 Private Placement Warrants |
|
|
|
$ |
|
|
|
|
|
|
|
|
||||||
Public Warrants |
|
|
|
$ |
|
|
|
|
|
|
|
|
||||||
January 2023 PIPE Warrants |
|
|
|
$ |
|
|
|
|
|
|
|
|
||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The following table summarizes warrant activity for the three months ended March 31, 2023:
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
|
Number of Common Warrants |
|
|
Weighted Average Exercise Price |
|
|
Average Remaining Contractual Term (Years) |
|
|
Aggregate Intrinsic Value |
|
|||||
Outstanding as of December 31, 2022 |
|
|
|
|
$ |
|
|
|
|
|
$ |
— |
|
|||
Warrants issued |
|
|
|
|
$ |
|
|
|
|
|
|
|
||||
Outstanding as of March 31, 2023 |
|
|
|
|
$ |
|
|
|
|
|
$ |
— |
|
The Company’s freestanding warrant instruments consist of private placement warrants to purchase shares of common stock (the “2020 Private Placement Warrants”) and public warrants to purchase shares of common stock (the “Public Warrants”) that were assumed as part of the Transaction. In addition, the Company issued the January 2023 PIPE Warrants in connection with the January 2023 PIPE. The January 2023 PIPE Warrants are considered freestanding instruments and are immediately exercisable for
12. Concentrations of Risk
The Company has certain customers whose revenue individually represented 10% or more of the Company’s total revenue or whose accounts receivable balances individually represented 10% or more of the Company’s total accounts receivable.
For the three months ended March 31, 2023 and 2022,
There were
13
13. Income Taxes
The Company had
Management of the Company evaluated the positive and negative evidence bearing upon the realizability of its deferred tax assets and determined that it is more likely than not that the Company will not recognize the benefits of the deferred tax assets. As a result, a full valuation allowance was recorded as of March 31, 2023.
The Company applies ASC 740, Income Taxes, for the financial statement recognition, measurement, presentation, and disclosure of uncertain tax positions taken or expected to be taken in income tax returns. Unrecognized tax benefits represent tax positions for which reserves have been established. A full valuation allowance has been provided against the Company’s deferred tax assets, so that the effect of the unrecognized tax benefits is to reduce the gross amount of the deferred tax asset and the corresponding valuation allowance. The Company has no material uncertain tax positions as of March 31, 2023. The Company has never been examined by the Internal Revenue Service, or any other jurisdiction, for any tax years and, as such, all years within the applicable statutes of limitations are potentially subject to audit.
14. Net Loss per Share – Basic and Diluted
For the three months ended March 31, 2023 and 2022, basic net loss per share is computed by dividing the net loss attributable to common stockholders by the weighted average number of common shares. Undistributed losses were allocated entirely to common stockholders since neither the convertible preferred stock nor the contingently returnable earn-out shares from the Transaction (the “Earn-Out Shares”) are required to share in the losses of the Company.
For the three months ended March 31, 2023 and 2022, diluted net loss per share is the same as basic net loss per share since the effect of considering options to purchase common stock, warrants to purchase common stock, Earn-Out Shares, and convertible preferred stock in the calculation would be antidilutive.
The following potentially dilutive common stock instruments presented based on amounts outstanding at each period end, were excluded from the computation of diluted net loss per share because including them would have had an antidilutive effect:
|
|
Three Months Ended March 31, |
|
|||||
|
|
2023 |
|
|
2022 |
|
||
Options to purchase common stock |
|
|
|
|
|
|
||
Earn-Out Shares |
|
|
|
|
|
— |
|
|
Convertible preferred stock (as converted to common stock) |
|
|
|
|
|
|
||
Warrants to purchase common stock |
|
|
|
|
|
— |
|
The following table sets forth the calculation of basic and diluted net loss per share:
|
|
Three Months Ended March 31, |
|
|||||
|
|
2023 |
|
|
2022 |
|
||
Net loss available to common stockholders — basic and diluted |
|
$ |
( |
) |
|
$ |
( |
) |
Weighted-average number of common shares used in |
|
|
|
|
|
|
||
Net loss per share attributable to common |
|
$ |
( |
) |
|
$ |
( |
) |
15. Commitments and Contingencies
Leases
On March 8, 2018, the Company entered into a non-cancelable operating lease agreement for office and laboratory space in Woburn, Massachusetts.
14
The maturities and balance sheet presentation under all non-cancelable operating leases as of March 31, 2023, are as follows:
|
|
Operating Leases |
|
|
Maturity of lease liabilities |
|
|
|
|
2023 |
|
$ |
|
|
2024 |
|
|
|
|
Total lease liabilities |
|
|
|
|
Less imputed interest |
|
|
( |
) |
Present value of operating lease liability as of March 31, 2023 |
|
$ |
|
|
Reported as of March 31, 2023 |
|
|
|
|
Lease liabilities — current |
|
$ |
|
|
Lease liabilities — noncurrent |
|
|
|
|
|
|
$ |
|
As the Company’s leases do not provide an implicit rate, the Company estimated its incremental borrowing rate based on the information available at each lease commencement date in determining the present value of the lease payments. The weighted-average discount rate used for leases as of March 31, 2023 is
Amounts included in restricted cash as of March 31, 2023 and December 31, 2022 included $
Legal Proceedings
The Company, from time to time, may be party to litigation arising in the ordinary course of business. The Company was not subject to any material legal proceedings as of March 31, 2023, and, to the best of the Company’s knowledge, no material legal proceedings are currently pending or threatened.
Indemnification Agreements
The Company enters into standard indemnification agreements in the ordinary course of business. Pursuant to the agreements, the Company agrees to indemnify, hold harmless, and to reimburse the indemnified party for losses suffered or incurred by the indemnified party, generally the Company’s business partners, in connection with any U.S. patent or any copyright or other intellectual property infringement claim by any third-party with respect to the Company’s products. The term of these indemnification agreements is generally perpetual any time after execution of the agreement. In addition, the Company has entered into indemnification agreements with members of its board of directors and its executive officers that will require the Company, among other things, to indemnify them against certain liabilities that may arise by reason of their status or service as directors or officers. In addition, the Company maintains officers and directors insurance coverage. The maximum potential amount of future payments the Company could be required to make under these indemnification agreements is unlimited. Through March 31, 2023, the Company had
15
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations.
You should read the following discussion and analysis of our financial condition and results of operations together with our unaudited consolidated financial statements and the notes thereto included elsewhere in this Quarterly Report on Form 10-Q as well as the audited consolidated financial statements and the related notes included in our 2022 Annual Report. Some of the information contained in this discussion and analysis or set forth elsewhere in this Quarterly Report on Form 10-Q, including information with respect to our plans and strategy for our business and related financing, includes forward-looking statements that involve risks, uncertainties and assumptions. You should read the “Forward-Looking Statements” and “Risk Factors” sections of this Quarterly Report on Form 10-Q and our 2022 Annual Report for a discussion of important factors that could cause actual results to differ materially from the results described in or implied by the forward-looking statements contained in the following discussion and analysis. For periods prior to the closing of the Transaction, the use of “our”, “we” and words of similar import in this Item 2 refer to our predecessor, Legacy Comera.
Forward Looking Statements
This Quarterly Report on Form 10-Q contains forward-looking statements. All statements other than statements of historical fact contained herein, including statements regarding our business plans or strategies, projected or anticipated benefits or other consequences of our plans or strategies, projected or anticipated benefits from acquisitions to be made by us, or projections involving anticipated revenues, earnings, or other aspects of our operating results, are forward-looking statements. Words such as “anticipates,” “assumes,” “believes,” “can,” “could,” “estimates,” “expects,” “forecasts,” “guides,” “intends,” “is confident that,” “may,” “plans,” “seeks,” “projects,” “targets,” and “would,” and their opposites and similar expressions, as well as statements in future tense, are intended to identify forward-looking statements. Forward-looking statements should not be read as a guarantee of future performance or results and may not be accurate indications of when such performance or results will actually be achieved. Forward-looking statements are based on information we have when those statements are made or our management’s good faith belief as of that time with respect to future events and are subject to risks and uncertainties that could cause actual performance or results to differ materially from those expressed in or suggested by the forward-looking statements. Important factors that could cause such differences include, but are not limited to:
Should one or more of these risks or uncertainties materialize or should any of the assumptions made by the management of the Company prove incorrect, actual results may vary in material respects from those projected in these forward-looking statements.
Except to the extent required by applicable law or regulation, the Company undertakes no obligation to update these forward-looking statements to reflect events or circumstances after the date of this Quarterly Report on Form 10-Q or to reflect the occurrence of unanticipated events.
16
Overview
Comera is a pre-clinical biotechnology company dedicated to promoting a compassionate new era in medicine by applying a deep knowledge of formulation science and technology to transform essential biologic medicines from intravenous to subcutaneous forms. Although Comera’s product candidates are at the pre-clinical stage and none have been approved for commercial sale, Comera’s internal portfolio of proprietary techniques known as the SQoreTM platform, is designed to potentially transform essential biologic medicines from intravenous (“IV”) to subcutaneous (“SQ”) forms, optimize current versions of subcutaneous biologics, and produce biosimilar versions of existing subcutaneous products. If successful, this transformation in administration could provide patients using biological products through intravenous infusion, and their families, the freedom of self-injectable care which, Comera believes, would allow them to enjoy both the potential benefits of biologic treatments and the potential of their own lives while simultaneously lowering healthcare costs. To accomplish this, Comera is developing an internal portfolio of proprietary therapeutic product candidates using its innovative proprietary formulation platform, SQoreTM. Comera also collaborates with pharmaceutical and biotechnology companies, applying the SQoreTM platform to our partners’ biologic medicines to deliver enhanced SQ formulations.
Business
Comera is a preclinical stage life sciences company dedicated to promoting a compassionate new era in medicine. We apply a deep knowledge of formulation science and proprietary technology to optimize biologic medicines. Our internal portfolio of proprietary techniques known as our SQore platform, is designed to potentially:
We aim to develop these potentialities in order to transform administration from IV to SQ and thereby provide patients using biological products through intravenous infusion, and their families, with the freedom of self-injectable care which, we believe, would allow them to enjoy both the potential benefits of biologic treatments and the potential of their own lives while simultaneously lowering healthcare costs and increasing patient compliance.
The SQore platform, which is the foundation of our work, is supported by an extensive patent portfolio and encompasses years of knowledge and development from our team of scientists, including industry-leading experts in polymer engineering and interfacial dynamics (the way that different molecules interact) who are inventors on dozens of patents and have published widely-cited research in their fields. We believe that our combined polymer and small molecule capability will allow us to leverage a mechanistic understanding of protein-protein and protein-solvent interactions to identify suitable excipients for specific formulations, which allows the active, therapeutic ingredient to enter the body and arrive with sufficient potency.
We aim to achieve our mission by developing our own portfolio of therapeutic product candidates and by collaborating with pharmaceutical and biotechnology companies to transform their biologic medicines into enhanced SQ formulations.
Since our founding in 2014, we primarily engaged in early-stage, preclinical studies, commissioned on a fee-for-service basis by larger pharmaceutical companies and have not yet developed any products approved for marketing. Our studies for larger companies were generally early-stage investigations, often amounting to proof-of-concept work, aimed at moving existing formulations from IV infusion to SQ delivery via injection.
In 2021, we brought on a new leadership team and carried out a transition of our business model. We shifted away from simple “fee for services” formulation work and focused our efforts on engaging with higher-value-add partners in integrated, collaborative projects to develop formulations for their key products. We are currently working with multiple companies under research and development service agreements. These agreements typically have a term of less than 12 months and provide for an initial payment by the company of a fee to Comera for the evaluation by Comera of its proprietary technology for viscosity reduction with the other company’s proprietary biotherapeutic agent. The agreements set forth the detailed research plans and the related timeline for completion of the research. The agreements provide that each party retains ownership of its technology throughout the process. Upon completion of the project, the parties may negotiate in good faith the terms of a license agreement. If the parties do not successfully negotiate a license, each party retains ownership of its technology and neither party may use the joint invention. Because these research and development service agreements may result in the future negotiation and execution of licensing agreements, we believe these projects provide far greater opportunities for generating revenue. When we meet our partners’ defined project criteria for the formulations, we will seek a license agreement to receive license fees, milestone payments, and longer-term and more stable royalty revenue on commercial assets that are vital to our partners.
On January 7, 2022, we changed our name to Comera Life Sciences, Inc. from ReForm Biologics, Inc. to emphasize our vision of a compassionate new era in medicine.
On May 19, 2022, we consummated the acquisition of all of the issued and outstanding shares of OTR Acquisition Corp. and Comera Life Sciences, Inc. The transaction was accounted for as a reverse recapitalization.
17
SQore Platform
Comera’s SQore platform, supported by an extensive patent portfolio and encompassing years of development and experience, is designed to enable the conversion of IV biologics to SQ versions. We believe that our team of experienced scientists includes industry-leading experts in polymer engineering and interfacial dynamics who are inventors on dozens of patents and have published widely-cited research in their fields. This expertise complements our solid grounding in traditional protein chemistry. Our combined polymer and small molecule capability allows us to leverage a mechanistic understanding of protein-protein and protein-solvent interactions to tailor excipient selection for specific formulation needs. This scientific foundation supports the SQore platform for our formulation work. Based on this platform, our technology has the potential to lower healthcare costs, increase patient compliance and enhance patient lives – all major factors which we believe will help set Comera apart from its peers in the years ahead.
Financial Overview
Revenue
Through March 31, 2023, we have generated revenue from the second phase of a research agreement with a partner. These arrangements generally represent formulation development collaborations with rights to negotiate product-specific licenses for a broad spectrum of protein-based therapeutics. Initially, arrangements have provided compensation for research efforts. The arrangements also provide that if the research efforts are successful, additional development and commercialization arrangements may be separately negotiated and executed, which may include upfront payments, milestones, and royalties on commercial sales. We generally expect revenue to increase as we execute additional research agreements and as planned development and collaboration arrangements are executed.
We have not generated any revenue from product sales and do not expect to generate any revenue from the sale of products in the near future. If development efforts for our pipeline programs are successful and result in regulatory approval, we may generate product revenue in the future.
Cost of Revenue
Cost of revenue generally consists of personnel expenses (comprised of salaries, bonuses, employee benefits and stock-based compensation expenses), and direct materials costs, third-party laboratory costs, and other costs necessary to complete the research arrangements. In addition, costs include allocated depreciation of laboratory equipment and amortization of leasehold improvements, and certain overhead expenses including facilities costs. Costs associated with revenue are recorded as the research is performed. We generally expect cost of revenue to increase as revenue increases, however margins on our customer contracts may vary widely.
Operating Expenses
Research and Development Expenses
Research and development expenses consist primarily of costs incurred in connection with the enhancement of our product platform and with the discovery and development of our pipeline programs. We expense research and development costs as incurred. These expenses include:
We recognize external development costs based on an evaluation of the progress to completion of specific tasks using information provided to us by our service providers.
18
Research and development activities are central to our business model. Current activities primarily relate to the enhancement of our SQore technology platform and other research activities, as well as initiation of formulation development work and manufacturing activities for our pipeline programs. We expect that our research and development expenses will increase substantially over the next several years including increased costs related to the development of pipeline programs, particularly as we increase personnel costs, including stock-based compensation, contractor costs and facilities costs and direct costs paid to contract research, development, and manufacturing organizations to conduct pipeline research and development activities on our behalf. In addition, if we elect to in-license or otherwise acquire additional pipeline products or additional intellectual property, we will also incur additional expenses which may include upfront, milestone and royalty payments payable to third parties.
The successful discovery, development and commercialization of our pipeline programs is highly uncertain. At this time, we cannot reasonably estimate or know the nature, timing and costs of the efforts that will be necessary to complete the discovery or development of any of our potential pipeline programs or when, if ever, material net cash inflows may commence from any of our pipeline programs.
Our research and development expenses are not currently tracked on a program-by-program basis. Our research and development expenses consist primarily of external costs, such as fees paid to outside consultants, contract research organizations, contract manufacturing organizations, and central laboratories, and internal costs such as employee costs and facility expenses, including depreciation or other indirect costs.
General and Administrative Expenses
General and administrative expenses consist primarily of salaries, related benefits, travel and stock-based compensation expense for personnel in executive, finance and administrative functions. General and administrative expenses also include professional fees for legal, consulting, accounting and audit services. In addition, general and administrative expenses also include costs incurred in connection with the Transaction, expenses primarily related to advisory, legal, and accounting fees.
We anticipate that our general and administrative expenses will increase in the future as we increase our headcount to support our continued research activities, and as a result of operating as a public company, including compliance with federal securities laws, legal, audit, additional insurance expenses, investor relations activities, and other administrative and professional services. We anticipate the additional costs for these services will substantially increase our general and administrative expenses. Additionally, if and when we believe a regulatory approval of a pipeline programs appears likely, we anticipate an increase in payroll and expense as a result of our preparation for commercial operations, especially as it relates to the sales and marketing of our pipeline programs.
Critical Accounting Policies and Significant Judgments and Estimates
Our condensed consolidated financial statements are prepared in accordance with generally accepted accounting principles in the United States. The preparation of our condensed consolidated financial statements and related disclosures requires us to make estimates and judgments that affect the reported amounts of assets, liabilities, revenue, costs and expenses, and the disclosure of contingent assets and liabilities in our condensed consolidated financial statements. We base our estimates on historical experience, known trends and events and various other factors that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. We evaluate our estimates and assumptions on an ongoing basis. Our actual results may differ from these estimates under different assumptions or conditions.
There were no changes to our critical accounting policies during the three months ended March 31, 2023, including estimates, assumptions, and judgments as compared to those described in Management’s Discussion and Analysis of Financial Condition and Results of Operations included in the 2022 Annual Report. It is important that the discussion of our operating results that follow be read in conjunction with the critical accounting policies disclosed in the 2022 Annual Report.
19
Results of Operations
Three Months Ended March 31, 2023 Compared with Three Months Ended March 31, 2022
The following table sets forth our results of operations for the three months ended March 31, 2023 and 2022:
|
|
Three Months Ended March 31, |
|
|
Change |
|
||||||||||
|
|
2023 |
|
|
2022 |
|
|
Dollar |
|
|
Percentage |
|
||||
Revenue |
|
$ |
392,915 |
|
|
$ |
95,334 |
|
|
$ |
297,581 |
|
|
|
312 |
% |
Cost of revenue |
|
|
116,519 |
|
|
|
44,524 |
|
|
|
71,995 |
|
|
|
162 |
% |
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Research and development |
|
|
343,705 |
|
|
|
487,217 |
|
|
|
(143,512 |
) |
|
|
(29 |
)% |
General and administrative |
|
|
2,433,147 |
|
|
|
2,016,245 |
|
|
|
416,902 |
|
|
|
21 |
% |
Total operating expenses |
|
|
2,776,852 |
|
|
|
2,503,462 |
|
|
|
273,390 |
|
|
|
11 |
% |
Loss from operations |
|
|
(2,500,456 |
) |
|
|
(2,452,652 |
) |
|
|
(47,804 |
) |
|
|
2 |
% |
Other income (expense), net |
|
|
19,144 |
|
|
|
(426,743 |
) |
|
|
445,887 |
|
|
|
(104 |
)% |
Net loss and comprehensive loss |
|
$ |
(2,481,312 |
) |
|
$ |
(2,879,395 |
) |
|
$ |
398,083 |
|
|
|
(14 |
)% |
Revenue
Revenue was $393 thousand for the three months ended March 31, 2023, compared to $95 thousand for the three months ended March 31, 2022. The increase of $298 thousand is primarily related to the extension and expansion of the ongoing research collaboration with Regeneron Pharmaceuticals.
Cost of Revenue
Cost of revenue was $117 thousand for the three months ended March 31, 2023, compared to $45 thousand for the three months ended March 31, 2022. The increase of $72 thousand is primarily related to higher direct labor costs incurred during the three months ended March 31, 2023, due to an increase in research activities performed under customer contracts.
Research and Development Expenses
The following table sets forth our research and development expenses for the three months ended March 31, 2023 and 2022:
|
|
Three Months Ended March 31, |
|
|
Change |
|
||||||||||
|
|
2023 |
|
|
2022 |
|
|
Dollar |
|
|
Percentage |
|
||||
Employee related |
|
$ |
214,691 |
|
|
$ |
242,112 |
|
|
$ |
(27,421 |
) |
|
|
(11 |
)% |
Lab supplies and materials |
|
|
71,806 |
|
|
|
187,311 |
|
|
|
(115,505 |
) |
|
|
(62 |
)% |
Occupancy and facility related |
|
|
46,713 |
|
|
|
34,953 |
|
|
|
11,760 |
|
|
|
34 |
% |
Other |
|
|
10,495 |
|
|
|
22,841 |
|
|
|
(12,346 |
) |
|
|
(54 |
)% |
Total research and development expense |
|
$ |
343,705 |
|
|
$ |
487,217 |
|
|
$ |
(143,512 |
) |
|
|
(29 |
)% |
Research and development expenses were $344 thousand for the three months ended March 31, 2023, compared to $487 thousand for the three months ended March 31, 2022. The overall decrease of $144 thousand is primarily related to lower lab supply expenses in three months ended March 31, 2023 and a greater allocation of resources to cost of revenue in three months ended March 31, 2023.
General and Administrative Expenses
General and administrative expenses were $2.4 million for the three months ended March 31, 2023, compared to $2.0 million for the three months ended March 31, 2022. The increase of $417 thousand is primarily related to increases in expenses in connection with the Company’s growth and costs associated with operating a public company. These increases include $331 thousand of personnel costs, $256 thousand of non-cash stock compensation fees, $107 thousand of patent fees, and $374 thousand of directors and officers liability insurance. These increases were partially offset by decreases of $414 thousand in consulting fees and $333 thousand of accounting fees.
Other Income (Expense), Net
For the three months ended March 31, 2023, total other income, net is comprised of a $27 thousand change in fair value of derivative warrant liabilities, partially offset by $8 thousand of interest expense.
20
For the three months ended March 31, 2022, total other expense, net primarily related to $427 thousand related to a loss on diverted funds, as previously disclosed.
Liquidity and Capital Resources
Since our inception, we have incurred significant operating losses. We do not have any products approved for sale and have not generated any revenue from product sales. As of March 31, 2023, we have generated revenue from research agreements with various partners. Our ability to generate revenue sufficient to achieve profitability will depend heavily on the successful development and eventual licensing and/or commercialization of one or more of our current or future pipeline programs as well as continued successful execution of pharmaceutical research collaborations and subsequent execution of collaboration programs. Our net loss was $2.5 million for the three months ended March 31, 2023. As of March 31, 2023, we had an accumulated deficit of $37.4 million. We expect to continue to incur losses for at least the next several years as we continue to develop our SQore platform and conduct research and development activities on our pipeline programs. In addition, we expect our expenses to increase as our pipeline programs advance into clinical development and eventual regulatory approval stages. If we obtain marketing approval for any of our pipeline programs, we expect to incur significant commercialization expenses related to product manufacturing, marketing, sales and distribution. As of March 31, 2023, the Company has not engaged in any off-balance sheet arrangements that have or are reasonably likely to have a current or future material effect on the Company’s financial condition, results of operations or cash flows.
On January 2, 2023, we entered into the 2023 PIPE Purchase Agreement with a select group of existing shareholders and members of the Company's board of directors (the “Purchasers”), pursuant to which the Company issued and sold to the Purchasers in a private placement of our securities an aggregate of 2,406,242 units (collectively, the “Units”), each Unit consisting of (i) one share of common stock, and (ii) one warrant (the “January 2023 PIPE Warrants”) to purchase two shares of common stock (the “Warrant Shares”) at an exercise price of $1.23 per Warrant Share, for an aggregate purchase price of approximately $3.6 million, consisting of $1.48 per Unit, inclusive of $0.25 per 2023 January PIPE Warrant. The financing closed on January 4, 2023 (the “January 2023 PIPE”), resulting in net proceeds of $3.2 million, after deducting offering costs of $361 thousand.
We will receive up to an aggregate of $127.0 million if all of the outstanding Public Warrants and 2020 Private Placement Warrants and $5.9 million if all of the outstanding January 2023 PIPE Warrants are exercised for cash. However, we will only receive such proceeds if and when the warrant holders exercise such warrants, and we believe the likelihood that holders of the Public Warrants will exercise their warrants, and therefore the amount of cash proceeds that we would receive, is dependent upon the market price of our common stock. The closing price of Comera common stock on Nasdaq on March 31, 2023 was $0.90, which is $10.60 below the exercise price of the Public Warrants. If the market price for Comera common stock does not increase from the current level, it is unlikely that any of the Public Warrants will be exercised.
We will need substantial additional funding to support our continuing operations and pursue our growth strategy. Until such time, if ever, that we can generate product revenue sufficient to achieve profitability, we expect to finance our cash needs through a combination of equity offerings, debt financings, collaboration agreements, government and other third-party funding, strategic alliances, licensing arrangements or marketing and distribution arrangements. Debt financing and equity financing, if available, may involve agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends. If we raise additional funds through government and other third-party funding, collaboration agreements, strategic alliances, licensing arrangements or marketing and distribution arrangements, we may have to relinquish valuable rights to our technologies, future revenue streams, pipeline programs or grant licenses on terms that may not be favorable to us. If we are unable to raise additional funds when needed, we may be required to delay, limit, reduce or terminate our product development or future commercialization efforts or grant rights to develop and market products or pipeline programs that we would otherwise prefer to develop and market ourselves.
Because of the numerous risks and uncertainties associated with product development, we are unable to predict the timing or amount of increased expenses or when or if we will be able to achieve or maintain profitability. Even if we are able to generate product sales, we may not become profitable. If we fail to become profitable or are unable to sustain profitability on a continuing basis, we may be unable to continue our operations at planned levels and be forced to reduce or terminate our operations.
We do not believe the cash and cash equivalents as of March 31, 2023 will be sufficient to fund our operations for the next twelve months from the date of issuance of the condensed consolidated financial statements. We will be required to raise additional capital to continue to fund operations and capital expenditures. Such funding may not be available on acceptable terms, or at all. If we are unable to access additional funds when needed, we may not be able to continue operations or we may be required to delay, scale back or eliminate some or all of our ongoing research and development efforts and other operations. Our ability to access capital when needed is not assured and, if not achieved on a timely basis, will materially harm our business, financial condition and results of operations. These uncertainties create substantial doubt about our ability to continue as a going concern.
21
Cash Flows
The following table sets forth the sources and uses of cash, cash equivalents, and restricted cash for the three months ended March 31, 2023 and 2022:
|
|
Three Months Ended March 31, |
|
|||||
|
|
2023 |
|
|
2022 |
|
||
Net cash used in operating activities |
|
$ |
(1,905,768 |
) |
|
$ |
(2,869,552 |
) |
Net cash used in investing activities |
|
|
(88,359 |
) |
|
|
— |
|
Net cash provided by financing activities |
|
|
1,580,548 |
|
|
|
222,513 |
|
Net decrease in cash, cash equivalents and |
|
$ |
(413,579 |
) |
|
$ |
(2,647,039 |
) |
Operating Activities
During the three months ended March 31, 2023, net cash used in operating activities was $1.9 million which consisted of a $2.5 million net loss, partially offset by $304 thousand of net non-cash adjustments to reconcile net loss to cash used in operating activities and $272 thousand of changes in operating assets and liabilities. Our net non-cash adjustments to reconcile net loss to cash used in operating activities were primarily comprised of $301 thousand of stock-based compensation expense and $28 thousand of depreciation expense, partially offset by $27 thousand change in fair value of derivative warrant liabilities. The net cash inflows associated with changes in operating assets and liabilities was primarily due to increases of $126 thousand in accounts payable and $138 thousand in accrued expenses and other current liabilities and decreases of $118 thousand in prepaid expenses and other current assets and $34 thousand in accounts receivable, partially offset by $144 thousand decrease in deferred revenue.
During the three months ended March 31, 2022, net cash used in operating activities was $2.9 million which consisted of a $2.9 million net loss, partially offset by $67 thousand of net non-cash adjustments to reconcile net loss to cash used in operating activities and $57 thousand of changes in operating assets and liabilities. Our net non-cash adjustments to reconcile net loss to cash used in operating activities were primarily comprised of $43 thousand of stock-based compensation expense and $25 thousand of depreciation expense. The net cash outflows associated with changes in operating assets and liabilities was primarily due to a decrease of $301 thousand in accrued expenses and other current liabilities and an increase of $148 thousand in accounts receivable, partially offset by increases of $123 thousand in accounts payable and $48 thousand in deferred revenue and a decrease of $221 thousand of prepaid expenses and other current assets.
Investing Activities
The cash outflows from investing activities for the three months ended March 31, 2023 related to the purchase of property and equipment. There were no investing activities for the three months ended March 31, 2022.
Financing Activities
Financing activities during the three months ended March 31, 2023 related to $2.0 million of net proceeds received from the January 2023 PIPE (excluding $1.5 million in proceeds received as advanced deposits on or prior to December 31, 2022) and $49 thousand of proceeds from the Arena Purchase Agreement, partially offset by $456 thousand of repayments under our insurance premium financing arrangement.
Financing activities during the three months ended March 31, 2022 related to $429 thousand of proceeds from the exercise of stock options, partially offset by $207 thousand of deferred offering costs paid in cash.
Known Trends, Events and Uncertainties
On April 10, 2023, President Biden signed a joint congressional resolution ending the national emergency related to COVID-19 and the Biden Administration previously announced it will end the public health emergency declaration related to COVID-19 on May 11, 2023. Nonetheless, COVID-19 continues to present a public health and economic challenge around the world. COVID-19 has resulted in significant economic uncertainty and volatility in the credit and capital markets and has caused global inflationary and supply chain pressures. As a result, we may not be able to raise sufficient capital to commercialize our current and future product candidates. The length of time and full extent to which COVID-19 may directly or indirectly impact our business, results of operations and financial condition will depend on future developments that are highly uncertain, subject to change and difficult to predict. We plan to continue to closely monitor the ongoing impact of COVID-19 (including the emergence of new variants) on our operations.
22
Other than as discussed above and elsewhere in this Quarterly Report on Form 10-Q, we are not aware of any trends, events or uncertainties that are likely to have a material effect on our financial condition.
Recently Issued Accounting Pronouncements
A description of recently issued accounting pronouncements that may potentially impact our financial position, results of operations or cash flows is disclosed in Note 2, Basis of Presentation and Significant Accounting Policies, to our condensed consolidated financial statements included elsewhere in this Quarterly Report on Form 10-Q.
Item 3. Quantitative and Qualitative Disclosures About Market Risk.
Not applicable.
Item 4. Controls and Procedures.
Disclosure Controls and Procedures
Disclosure controls and procedures are controls and other procedures that are designed to ensure that information required to be disclosed in our reports filed or submitted under the Securities Exchange Act of 1934, as amended (the “Exchange Act”), is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms. Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that information required to be disclosed in company reports filed or submitted under the Exchange Act is accumulated and communicated to management, including our Chief Executive Officer and Chief Financial Officer, as appropriate, to allow timely decisions regarding required disclosure.
Our Chief Executive Officer and Chief Financial Officer, after evaluating the effectiveness of our disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) as of March 31, 2023, have concluded that, based on such evaluation, our disclosure controls and procedures were effective.
Changes in Internal Control Over Financial Reporting
There were no changes in our internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and
15d-15(f)) during the quarter ended March 31, 2023 that have materially affected, or are reasonably likely to materially affect, our
internal control over financial reporting.
Limitations of the Effectiveness of Internal Controls
A control system, no matter how well conceived and operated, can provide only reasonable, not absolute, assurance that the objectives of the internal control system are met. Because of the inherent limitations of any internal control system, no evaluation of controls can provide absolute assurance that all control issues, if any, within a company have been detected.
23
PART II—OTHER INFORMATION
Item 1. Legal Proceedings.
From time to time, we may be involved in litigation that arises through the normal course of business. As of the date of this filing, we are not aware of any material legal proceedings to which we or any of our subsidiaries is a party or to which any of our property is subject, nor are we aware of any such threatened or pending litigation or any such proceedings known to be contemplated by governmental authorities.
We are not aware of any material proceedings in which any of our directors, officers, or affiliates or any registered or beneficial stockholder of more than 5% of our common stock, or any associate of any of the foregoing, is a party adverse to or has a material interest adverse to, us or any of our subsidiaries.
Item 1A. Risk Factors.
Our business faces significant risks and uncertainties. Certain factors may have a material adverse effect on our business prospects, financial condition and results of operations, and you should carefully consider them. Accordingly, in evaluating our business, we encourage you to consider the risks described in the section of our 2022 Annual Report entitled “Item 1A. Risk Factors.” Other than those listed below, there have been no material changes to such risk factors during the quarter ended March 31, 2023. Other events that we do not currently anticipate or that we currently deem immaterial may also affect our business, prospects, financial condition and results of operations.
There can be no assurance that we will be able to comply with the continued listing standards of Nasdaq.
Our common stock and our Public Warrants are listed on Nasdaq. There can be no assurance that we will continue to meet Nasdaq’s listing standards. On November 18, 2022, we received a letter from the Nasdaq Listing Qualifications department staff of Nasdaq notifying us that, for the then prior 30 consecutive business days, the minimum Market Value of Listed Securities (“MVLS”) was below the minimum $35 million required for continued listing on Nasdaq, pursuant to Nasdaq Listing Rule 5550(b)(2). In accordance with Nasdaq listing rule 5810(c)(3)(C), we have 180 calendar days, or until May 17, 2023 (the “Compliance Period”), to regain compliance. The notice states that to regain compliance, the Company’s MVLS must close at or above $35 million for a minimum of ten consecutive business days (or such longer period of time as the Nasdaq staff may require in some circumstances, but generally not more than 20 consecutive business days) during the Compliance Period. We may also regain compliance by meeting the continued listing standard of a minimum stockholders’ equity of at least $2.5 million. If we do not regain compliance by May 17, 2023, Nasdaq staff will provide written notice to the Company that its securities are subject to delisting. At that time, we may appeal any such delisting determination to a Nasdaq hearings panel.
In addition, on May 2, 2023, we received a letter from the Nasdaq Listing Qualifications department staff notifying us that we are not in compliance with the $1.00 minimum bid price requirement for continued listing on Nasdaq, as set forth in Listing Rule 5550(a)(2). In accordance with Listing Rule 5810(c)(3)(A), the Company has a period of 180 calendar days, or until October 30, 2023, to regain compliance with the minimum bid price requirement. To regain compliance, the closing bid price of the Company’s common stock must meet or exceed $1.00 per share for a minimum of ten consecutive business days during this 180-day period. If the Company is not in compliance by October 30, 2023, the Company may be eligible for additional time to regain compliance. To qualify, the Company would be required to meet the continued listing requirement for market value of publicly held shares and all other initial listing standards for Nasdaq, except for the minimum bid price requirement. In addition, the Company would be required to notify Nasdaq of its intent to cure the minimum bid price deficiency. If the Company does not regain compliance within the allotted compliance periods, including any extensions that may be granted by Nasdaq, Nasdaq will provide notice that the Company’s common stock will be subject to delisting. The Company would then be entitled to appeal Nasdaq’s determination, but there can be no assurance that Nasdaq would grant the Company’s request for continued listing.
If we do not regain compliance, we and our stockholders could face significant material adverse consequences, including:
24
The National Securities Markets Improvement Act of 1996, which is a federal statute, prevents or preempts the states from regulating the sale of certain securities, which are referred to as “covered securities.” If our common stock remains listed on Nasdaq, it will be considered a covered security. Although the states are preempted from regulating the sale of our securities, the federal statute does allow the states to investigate companies if there is a suspicion of fraud, and, if there is a finding of fraudulent activity, then the states can regulate or bar the sale of covered securities in a particular case. Further, if we were not listed on Nasdaq, our securities would not be covered securities and we would be subject to regulation in each state in which it offers its securities.
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds.
As previously disclosed in the Company’s Current Report on Form 8-K filed on August 31, 2022, the Company entered into the Arena Purchase Agreement with Arena. As of May 12, 2023, the Company has sold an aggregate of 512,985 shares of its Common Stock at a weighted average price of approximately $1.71 per share for aggregate gross proceeds of approximately $879 thousand pursuant to the Arena Purchase Agreement. Of the 512,985 shares of Common Stock sold pursuant to the Arena Purchase Agreement, 37,230 shares of Common Stock were sold in the three months ended March 31, 2023, at a weighted average price of $1.32 per share, resulting in net proceeds of $49 thousand. The purchase price of the shares sold to Arena was equal to 96% of the simple average of the daily VWAP of the Company’s Common Stock immediately preceding the time of sale, as computed under the Arena Purchase Agreement. The issuances of the shares of the Company’s Common Stock pursuant to the Arena Purchase Agreement were deemed to be exempt from registration under Section 4(a)(2) of the Securities Act as a sale to an “accredited investor” as defined in Rule 501(a) of the Securities Act.
Item 3. Defaults Upon Senior Securities.
None.
Item 4. Mine Safety Disclosures.
Not applicable.
Item 5. Other Information.
None.
25
Item 6. Exhibits.
Exhibit Number |
|
Description |
2.1 |
|
|
2.2 |
|
|
3.1 |
|
|
3.2 |
|
|
3.3 |
|
|
4.1 |
|
|
10.1 |
|
|
10.2 |
|
|
31.1* |
|
|
31.2* |
|
|
32.1* |
|
|
32.2* |
|
|
101.INS |
|
Inline XBRL Instance Document – the instance document does not appear in the Interactive Data File because XBRL tags are embedded within the Inline XBRL document. |
101.SCH |
|
Inline XBRL Taxonomy Extension Schema Document |
101.CAL |
|
Inline XBRL Taxonomy Extension Calculation Linkbase Document |
101.DEF |
|
Inline XBRL Taxonomy Extension Definition Linkbase Document |
101.LAB |
|
Inline XBRL Taxonomy Extension Label Linkbase Document |
101.PRE |
|
Inline XBRL Taxonomy Extension Presentation Linkbase Document |
104 |
|
Cover Page Interactive Data File (embedded within the Inline XBRL document) |
* Filed herewith.
26
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
|
|
|
|
|
COMERA LIFE SCIENCES HOLDINGS, INC. |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Date: |
May 12, 2023 |
|
|
|
By: |
/s/ Jeffrey S. Hackman |
|
|
|
|
|
|
Name: Jeffrey S. Hackman |
|
|
|
|
|
|
|
Title: Chairman, President and Chief Executive Officer |
||
|
|
|
|
|
|
(Principal Executive Officer) |
|
|
|
|
|
|
|
|
|
Date: |
May 12, 2023 |
|
|
|
By: |
/s/ Michael Campbell |
|
|
|
|
|
|
Name: Michael Campbell |
|
|
|
|
|
|
|
Title: Executive Vice President and Chief Financial Officer |
||
|
|
|
|
|
|
(Principal Financial and Accounting Officer) |
|
27