UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 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 Identification No.) |
(Address of principal executive offices) |
(Zip Code) |
Registrant’s telephone number, including area code: (
Securities registered pursuant to Section 12(b) of the Act:
Title of each class |
|
Trading Symbol(s) |
|
Name of each exchange on which registered |
|
|
The |
||
|
|
The |
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. Yes ☐
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 |
|
☐ |
|
Accelerated filer |
|
☐ |
|
☒ |
|
Smaller reporting company |
|
||
Emerging growth company |
|
|
|
|
|
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
Indicate by check mark whether the registrant has filed all documents and reports required to be filed by Sections 12, 13 or 15(d) of the Securities Exchange Act of 1934 subsequent to the distribution of securities under a plan confirmed by a court. Yes ☒ No ☐
As of April 30, 2024, the registrant had
Table of Contents
|
|
Page |
|
|
|
PART I. |
1 |
|
|
|
|
Item 1. |
1 |
|
|
1 |
|
|
2 |
|
|
Condensed Consolidated Statements of Changes in Stockholders' Deficit (Unaudited) |
3 |
|
4 |
|
|
5 |
|
Item 2. |
Management’s Discussion and Analysis of Financial Condition and Results of Operations |
18 |
Item 3. |
24 |
|
Item 4. |
24 |
|
|
|
|
PART II. |
26 |
|
|
|
|
Item 1. |
26 |
|
Item 1A. |
26 |
|
Item 2. |
26 |
|
Item 3. |
26 |
|
Item 4. |
26 |
|
Item 5. |
26 |
|
Item 6. |
27 |
|
28 |
i
PART I—FINANCIAL INFORMATION
Item 1. Condensed Consolidated Financial Statements.
SeaStar Medical Holding Corporation
Condensed Consolidated Balance Sheets
(in thousands, except for share and per-share amounts)
|
|
|
|
|
|
|
||
|
|
March 31, |
|
|
December 31, |
|
||
|
|
(unaudited) |
|
|
|
|
||
ASSETS |
|
|||||||
Current assets |
|
|
|
|
|
|
||
Cash |
|
$ |
|
|
$ |
|
||
Prepaid expenses |
|
|
|
|
|
|
||
Total current assets |
|
|
|
|
|
|
||
Other assets |
|
|
|
|
|
|
||
Total assets |
|
$ |
|
|
$ |
|
||
|
|
|
|
|
|
|
||
LIABILITIES AND STOCKHOLDERS' DEFICIT |
|
|||||||
Current liabilities |
|
|
|
|
|
|
||
Accounts payable |
|
$ |
|
|
$ |
|
||
Accrued expenses |
|
|
|
|
|
|
||
Contingent upfront payment for license agreement |
|
|
|
|
|
|
||
Notes payable, net of deferred financing costs |
|
|
|
|
|
|
||
Convertible notes, current portion |
|
|
|
|
|
|
||
Liability classified warrants |
|
|
|
|
|
|
||
Total current liabilities |
|
|
|
|
|
|
||
Notes payable, net of deferred financing costs |
|
|
|
|
|
|
||
Convertible notes, net of current portion |
|
|
|
|
|
|
||
Total liabilities |
|
|
|
|
|
|
||
|
|
|
|
|
|
|||
Stockholders' deficit |
|
|
|
|
|
|
||
Preferred stock - $ |
|
|
|
|
|
|
||
Common stock - $ |
|
|
|
|
|
|
||
Additional paid-in capital |
|
|
|
|
|
|
||
Accumulated deficit |
|
|
( |
) |
|
|
( |
) |
Total stockholders' deficit |
|
|
( |
) |
|
|
( |
) |
Total liabilities and stockholders' deficit |
|
$ |
|
|
$ |
|
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
1
SeaStar Medical Holding Corporation
Condensed Consolidated Statements of Operations
(unaudited)
(in thousands, except for share and per-share amounts)
|
|
Three Months Ended March 31, |
|
|||||
|
|
2024 |
|
|
2023 |
|
||
|
|
|
|
|
|
|
||
Operating expenses |
|
|
|
|
|
|
||
Research and development |
|
$ |
|
|
$ |
|
||
General and administrative |
|
|
|
|
|
|
||
Total operating expenses |
|
|
|
|
|
|
||
Loss from operations |
|
|
( |
) |
|
|
( |
) |
Other income (expense) |
|
|
|
|
|
|
||
Interest expense |
|
|
( |
) |
|
|
( |
) |
Change in fair value of convertible notes |
|
|
( |
) |
|
|
|
|
Change in fair value of warrants liability |
|
|
( |
) |
|
|
|
|
Change in the fair value of the forward purchase agreement derivative liability |
|
|
|
|
|
( |
) |
|
Total other income (expense), net |
|
|
( |
) |
|
|
( |
) |
Loss before provision for income taxes |
|
|
( |
) |
|
|
( |
) |
Provision for income taxes |
|
|
|
|
|
|
||
Net loss |
|
$ |
( |
) |
|
$ |
( |
) |
Net loss per share of common stock, basic and diluted |
|
$ |
( |
) |
|
$ |
( |
) |
Weighted-average shares outstanding, basic and diluted |
|
|
|
|
|
|
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
2
SeaStar Medical Holding Corporation
Condensed Consolidated Statements of Changes in Stockholders' Deficit
(unaudited)
(in thousands, except for share and per-share amounts)
|
|
Stockholders' Deficit (unaudited) |
|
|||||||||||||||||
|
|
Common Shares |
|
|
|
|
|
|
|
|
|
|
||||||||
|
|
Shares |
|
|
Amount |
|
|
Additional Paid-In Capital |
|
|
Accumulated Deficit |
|
|
Total Stockholders' Deficit |
|
|||||
Balance, December 31, 2022 |
|
|
|
|
$ |
|
|
$ |
|
|
$ |
( |
) |
|
$ |
( |
) |
|||
Issuance of shares - equity line of credit |
|
|
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
|
|||
Issuance of shares - commitment fee for equity line of credit |
|
|
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
|
|||
Issuance of shares - prepaid forward contracts |
|
|
— |
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
|
||
Stock-based compensation |
|
|
— |
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
|
||
Net loss |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
( |
) |
|
|
( |
) |
Balance, March 31, 2023 |
|
|
|
|
$ |
|
|
$ |
|
|
$ |
( |
) |
|
$ |
( |
) |
|||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||
Balance, December 31, 2023 |
|
|
|
|
$ |
|
|
$ |
|
|
$ |
( |
) |
|
$ |
( |
) |
|||
Issuance of shares - conversion of convertible notes |
|
|
|
|
|
|
|
|
|
|
|
— |
|
|
|
|
||||
Issuance of shares - exercise of warrants |
|
|
|
|
|
|
|
|
|
|
|
— |
|
|
|
|
||||
Issuance of shares - equity offering, net of issue costs |
|
|
|
|
|
|
|
|
|
|
|
— |
|
|
|
|
||||
Stock-based compensation |
|
|
— |
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
|
||
Net loss |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
( |
) |
|
|
( |
) |
Balance, March 31, 2024 |
|
|
|
|
$ |
|
|
$ |
|
|
$ |
( |
) |
|
$ |
( |
) |
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements
3
SeaStar Medical Holding Corporation
Condensed Consolidated Statements of Cash Flows
(unaudited)
(in thousands, except for shares and per-share amounts)
|
|
Three Months Ended March 31, |
|
|||||
|
|
2024 |
|
|
2023 |
|
||
|
|
|
|
|
|
|
||
Cash flows from operating activities |
|
|
|
|
|
|
||
Net loss |
|
$ |
( |
) |
|
$ |
( |
) |
Adjustments to reconcile net loss to net cash used in operating activities |
|
|
|
|
|
|
||
Amortization of deferred financing costs |
|
|
|
|
|
|
||
Change in fair value of convertible notes (issued, converted and outstanding) |
|
|
|
|
|
|
||
Change in fair value of forward purchase agreement derivative liability |
|
|
|
|
|
( |
) |
|
Change in fair value of liability classified warrants (exercised and outstanding) |
|
|
|
|
|
( |
) |
|
Stock-based compensation |
|
|
|
|
|
|
||
Changes in operating assets and liabilities |
|
|
|
|
|
|
||
Other receivables |
|
|
|
|
|
|
||
Prepaid expenses |
|
|
|
|
|
|
||
Other assets |
|
|
|
|
|
|
||
Accounts payable |
|
|
( |
) |
|
|
|
|
Accrued expenses |
|
|
|
|
|
|
||
Other liabilities |
|
|
|
|
|
|
||
Net cash used in operating activities |
|
|
( |
) |
|
|
( |
) |
|
|
|
|
|
|
|
||
Cash flows from financing activities |
|
|
|
|
|
|
||
Proceeds from issuance of convertible notes |
|
|
|
|
|
|
||
Payment of convertible notes |
|
|
|
|
|
( |
) |
|
Proceeds from issuance of shares |
|
|
|
|
|
|
||
Proceeds from exercise of convertible note warrants |
|
|
|
|
|
|
||
Proceeds of Pre-Funded warrants |
|
|
|
|
|
|
||
Payment of commitment fee - equity line of credit |
|
|
|
|
|
( |
) |
|
Proceeds from sale of recycled shares |
|
|
|
|
|
|
||
Proceeds from notes payable |
|
|
|
|
|
|
||
Payment of notes payable |
|
|
( |
) |
|
|
( |
) |
Net cash provided by financing activities |
|
|
|
|
|
|
||
Net increase in cash |
|
|
|
|
|
|
||
Cash, beginning of period |
|
|
|
|
|
|
||
Cash, end of period |
|
$ |
|
|
$ |
|
Supplemental disclosure of cash flow information |
|
|
|
|
|
|
||
Cash paid for interest |
|
$ |
|
|
$ |
|
||
Exercise of pre-funded warrants |
|
$ |
|
|
$ |
|
||
Shares issued as payment of convertible notes |
|
$ |
|
|
$ |
|
||
Issuance of convertible note warrants |
|
$ |
|
|
$ |
|
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
4
Notes to the Unaudited Condensed Consolidated Financial Statements
(in thousands, except for shares and per-share amounts)
Note 1. Description of Business
Organization and description of business
SeaStar Medical Holding Corporation, a Delaware corporation ("SeaStar", "we") and its wholly owned subsidiary, SeaStar Medical, Inc., are collectively referred to as the "Company". SeaStar Medical, Inc. was incorporated as a Delaware corporation in June 2007, and it is headquartered in Denver, Colorado. The Company is principally engaged in the research, development, and commercialization of a platform medical device technology designed to modulate inflammation in various patient populations. The primary target of this technology is for the treatment of acute kidney injuries.
The Company is in the pre-revenue stage focused on product development.
On October 28, 2022, LMF Merger Sub, Inc., a wholly owned subsidiary of LMF Acquisition Opportunities, Inc., (“LMAO”) merged with and into SeaStar Medical, Inc. (the "Business Combination"), with SeaStar Medical, Inc. surviving the Business Combination as a wholly owned subsidiary of LMAO. Following the consummation of the Business Combination, LMAO was renamed to "SeaStar Medical Holding Corporation."
Basis of presentation and consolidation
The accompanying unaudited condensed consolidated financial statements have been prepared in conformity with accounting principles generally accepted in the United States of America ("U.S. GAAP") and the rules and regulations of the Securities and Exchange Commission ("SEC") for interim reporting. As permitted under those rules and regulations, certain notes or other financial information normally included in financial statements prepared in accordance with U.S. GAAP have been condensed or omitted. The interim unaudited condensed consolidated financial statements have been prepared on the same basis as the annual consolidated financial statements and, in the opinion of management, reflect all adjustments, which include only normal, recurring adjustments that are necessary to present fairly the Company’s results for the interim periods presented. The results from operations for the three months ended March 31, 2024, are not necessarily indicative of the results to be expected for the year ended December 31, 2024, or for any future annual or interim period.
The accompanying interim unaudited condensed consolidated financial statements should be read in conjunction with the annual consolidated financial statements and the related notes for the year ended December 31, 2023. There have been no material changes in our significant accounting policies as described in our Annual Report on Form 10-K for the year ended December 31, 2023.
The interim unaudited condensed consolidated financial statements include the consolidated accounts of the Company's wholly owned subsidiary, SeaStar Medical, Inc. All significant intercompany transactions have been eliminated in consolidation.
Segment information
The Company operates in one operating segment and, accordingly, no segment disclosures have been presented herein.
Liquidity and going concern
As of March 31, 2024, the Company has an accumulated deficit of $
5
Notes to the Unaudited Condensed Consolidated Financial Statements
(in thousands, except for shares and per-share amounts)
Our need for additional capital will depend in part on the scope and costs of our development activities. To date, we have not generated any revenue from the sales of commercialized products. Our ability to generate product revenue will depend on the successful development and eventual commercialization of our product. Until such time, if ever, we expect to finance our operations through the sale of equity or debt, borrowing under credit facilities, or through potential collaborations, other strategic transactions or government and other grants. Adequate capital may not be available to us when needed or on acceptable terms.
Risks and uncertainties
The Company is subject to risks common to early-stage companies in the medical technology industry including, but not limited to, new medical and technological innovations, dependence on key personnel, protection of proprietary technology, and product liability. There can be no assurance that the Company's products or services will be accepted in the marketplace, nor can there be any assurance that any future products or services can be developed or deployed at an acceptable cost and with appropriate performance characteristics, or that such products or services will be successfully marketed, if at all. These factors could have a materially adverse effect on the Company's future financial results, financial position and cash flows.
Note 2. Summary of Significant Accounting Policies
Use of estimates
The preparation of the unaudited interim condensed consolidated financial statements in conformity with U.S. GAAP requires management to make estimates, assumptions and judgments that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the consolidated financial statements and reported amounts of revenues and expenses during the period. Significant estimates include the valuation of the liability classified warrants, prepaid forward purchase agreement derivative liability, provision for income taxes, convertible debt measured at fair value, and the amount of stock-based compensation expense. Although actual results could differ from those estimates, such estimates are developed based on the best information available to management and management's best judgments at the time.
Concentrations of credit risk
Financial instruments that potentially subject the Company to a significant concentration of credit risk consist primarily of cash. Periodically, the Company may maintain deposits in financial institutions in excess of government insured limits. Any loss incurred or a lack of access to such funds could have a significant adverse impact on the Company's financial condition, results of operations, and cash flows.
Fair value of financial instruments
The following provides a summary of those assets or liabilities for which the Company is required to measure at fair value either on a recurring basis, the valuation techniques and summary of inputs used to arrive at the measure of fair value. Changes in fair value of these assets or liabilities are recognized as a component of net income in the consolidated statement of operations. Changes in fair value of these assets or liabilities are considered unrealized gains or losses and therefore are classified as non-cash adjustments to reconcile net income to operating cash flows. Significant increases (decreases) in unobservable inputs used in fair value measurements could, in isolation, potentially result in a significantly lower or higher valuation for those assets or liabilities requiring recurring fair value measurements at each reporting date.
The Company uses a Black-Scholes option pricing model to fair value Warrants, using standard option pricing inputs such as the strike price of each warrant tranche, estimated volatility, time to maturity, and the risk-free interest rate. The risk-free interest rate is the U.S. Treasury rate at the date of issuance, and the time to maturity is based on the contractual life at the date of issuance, which is an interpolated value based on the remaining term of each individual instrument. The change in fair value of the liability classified warrants each reporting period is recorded to the change in fair value of warrants liability in the consolidated statement of operations.
6
Notes to the Unaudited Condensed Consolidated Financial Statements
(in thousands, except for shares and per-share amounts)
Emerging growth company status
The Company is an “emerging growth company”, as defined in the Jumpstart Our Business Startups Act of 2012 ("JOBS Act"). Under the JOBS Act, emerging growth companies can take advantage of an extended transition period for complying with new or revised accounting standards, delaying the adoption of these accounting standards until they would apply to private companies. The Company has elected to use this extended transition period for complying with certain new or revised accounting standards that have different effective dates for public and private companies until the earlier of the date that it is (1) no longer an emerging growth company or (2) affirmatively and irrevocably opt out of the extended transition period provided in the JOBS Act.
Recently issued accounting standards
In December 2023, the Financial Accounting Standards Board (“FASB”) issued ASU 2023-09 Income Taxes (Topic 740) Improvements to Income Tax Disclosures. ASU 2023-09 enhances the transparency and decision usefulness of income tax disclosures. The amendments in this update are effective for public business entities for annual periods beginning after December 15, 2024. Early adoption is permitted. We are currently assessing the impact of this guidance on our disclosures.
Note 3. Accrued Expenses
Accrued expenses consisted of the following amounts as of March 31, 2024 and December 31, 2023:
($ in thousands) |
March 31, |
|
|
December 31, |
|
||
Accrued bonus |
$ |
|
|
$ |
|
||
Accrued director compensation |
|
|
|
|
|
||
Accrued research and development |
|
|
|
|
|
||
Accrued legal |
|
|
|
|
|
||
Accrued interest |
|
|
|
|
|
||
Other |
|
|
|
|
|
||
Total accrued expenses |
$ |
|
|
$ |
|
Note 4. Notes Payable
Notes payable activity was as follows for the three month period ended March 31, 2024:
($ in thousands) |
|
|
|
LMFA |
|
|
LMFAO |
|
|
Maxim |
|
|
Insurance Financing |
|
|
Unamortized deferred financing costs |
|
|||||
Balance as of December 31, 2023 |
|
|
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
( |
) |
||||
Payments |
|
|
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
|
|
— |
|
Amortization of costs |
|
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
|
Balance as of March 31, 2024 |
|
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
|
|
$ |
|
|
$ |
( |
) |
Future maturities of principal repayment of the notes payable as of March 31, 2024 are as follows:
7
Notes to the Unaudited Condensed Consolidated Financial Statements
(in thousands, except for shares and per-share amounts)
($ in thousands) |
|
|
|
|
|
|
|
|
2024 (remaining) |
|
|
|
|
|
$ |
|
|
2025 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
|
Senior Secured LMFA Note Payable
The company entered into a senior secured note with LMFA in September 2022. The interest rate on the loan was
Senior Secured LMFAO Note Payable
The company entered into a senior secured note with LMFAO in October 2022. The interest rate on the loan was
Unsecured Maxim Note Payable
In October 2022, the Company entered into an unsecured promissory note with Maxim, for an aggregate principal amount of $
Insurance Financing
In October 2023, the Company entered into a financing arrangement with a lender to finance a portion of the annual premium of an insurance policy in the amount of $
Note 5. Convertible Notes
The Company completed Additional Closings related to the Second Amendment to the Investor D SPA on January 12, 2024 and January 24, 2024, issuing notes in principal amounts of $
8
Notes to the Unaudited Condensed Consolidated Financial Statements
(in thousands, except for shares and per-share amounts)
($ in thousands) |
|
3rd Investor D Note |
|
|
3rd Investor D Note |
|
|
3rd Investor D Note |
|
|
3rd Investor D Note |
|
|
4th Investor D Note |
|
|
5th Investor D Note |
|
|
6th Investor D Note |
|
|
Total |
|
||||||||
Balance as of December 31, 2023 |
$ |
|
|
|
|
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
|
|
$ |
|
||||||||
Issuance (Face Value) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||
Fair value of detachable warrants at issuance |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
|||||
(Gain)/Loss on conversion |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||
Conversion to common stock |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
(Gain)/Loss on reporting period remeasurement |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||
Balance as of March 31, 2024 |
$ |
|
|
|
|
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
|
|
|
|
Future maturities of principal repayment of convertible Notes as of March 31, 2024, was as follows:
($ in thousands) |
|
|
|
|
|
|
|
|
2024 (remaining) |
|
|
|
|
|
$ |
|
|
2025 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
|
On January 30, 2024, the institutional investor agreed to waive its Optional Redemption Rights and any event of default that may arise thereunder with respect to this offering and suspend the Optional Redemption Rights for a period of sixty (
During the quarter-ended March 31, 2024, the institutional investor converted approximately $
The Company incurred a loss of approximately $
Note 6. Equity Transactions
On January 26, 2024, the Company entered into a Securities Purchase Agreement with a single institutional investor, pursuant to which the Company issued to the Purchaser (the "Q1 2024 SPA"), (i) in a registered direct offering,
The Company received aggregate gross proceeds from the Transactions of approximately $
9
Notes to the Unaudited Condensed Consolidated Financial Statements
(in thousands, except for shares and per-share amounts)
Date and the Series B Common Warrants will expire on the 12 month anniversary of the Stockholder Approval Date. The Pre-Funded Warrants will not expire and will be exercisable commencing on January 26, 2024, and at any time until all of the Pre-Funded Warrants are exercised in full. All Pre-Funded Warrants were exercised during the first quarter ended March 31, 2024.
The Company paid approximately $
Tumin Equity Line of Credit
During the year ended December 31, 2023, the Company sold
Note 7. Warrants
Warrants Issued in FY 2024
As discussed in Note 7, as part of the Q1 2024 SPA, the Company issued on January 26, 2024 the following warrants to purchase the Company's common stock:
Maxim Group LLC acted as the placement agent in connection with the Transactions pursuant to the Placement Agency Agreement, dated January 26, 2024, by and between the Company and the Placement Agent. The Placement Agent will receive warrants to purchase common stock covering a number of shares equal to
In accordance with ASC 815-40, Derivatives and Hedging-Contracts in Entity’s own Equity, the Company determined the Investor E and PA Warrants meet the conditions for equity classification, and should be carried on the consolidated balance sheets as a component of stockholders equity (deficit). The initial fair value of the convertible note warrants was determined using a Black-Scholes option pricing model, which considers variables such as estimated volatility, time to maturity, and the risk-free interest rate. The risk-free interest rate is the U.S. Treasury rate at the date of issuance, and the time to maturity is based on the contractual life at the date of issuance, which is five years.
The Company had the following warrants outstanding at March 31, 2024 and December 31, 2023:
10
Notes to the Unaudited Condensed Consolidated Financial Statements
(in thousands, except for shares and per-share amounts)
|
|
March 31, |
|
|
December 31, |
|
||
Liability Classified Warrants |
|
|
|
|
|
|
||
Investor D Warrants |
|
|
|
|
|
|
||
Private Placement Warrants |
|
|
|
|
|
|
||
PIPE Investor Warrants |
|
|
|
|
|
|
||
Subtotal |
|
|
|
|
|
|
||
|
|
|
|
|
|
|
||
Equity Classified Warrants |
|
|
|
|
|
|
||
Investor E Warrants |
|
|
|
|
|
|
||
Placement agent Warrants |
|
|
|
|
|
|
||
Public Stockholders' Warrants |
|
|
|
|
|
|
||
Legacy Warrants |
|
|
|
|
|
|
||
Subtotal |
|
|
|
|
|
|
||
Grand Total |
|
|
|
|
|
|
The following tables provides the weighted-average strike price and time to maturity for each warrant tranche as of March 31, 2024 and December 31, 2023:
March 31, 2024 |
|
Warrant Share Equivalents |
|
|
Weighted-Average Strike Price |
|
|
Weighted-Average Time to Maturity |
|
|||
Liability Classified Warrants |
|
|
|
|
|
|
|
|
|
|||
Investor D Warrants |
|
|
|
|
$ |
|
|
|
|
|||
Private Placement Warrants |
|
|
|
|
$ |
|
|
|
|
|||
PIPE Investor Warrants |
|
|
|
|
$ |
|
|
|
|
|||
|
|
|
|
|
|
|
|
|
|
|||
Equity Classified Warrants |
|
|
|
|
|
|
|
|
|
|||
Investor E Warrants |
|
|
|
|
$ |
|
|
|
|
|||
Placement Agent Warrants |
|
|
|
|
$ |
|
|
|
|
|||
Public Stockholders' Warrants |
|
|
|
|
$ |
|
|
|
|
|||
Legacy SeaStar Inc. Warrants |
|
|
|
|
$ |
|
|
|
|
December 31, 2023 |
|
Warrant Share Equivalents |
|
|
Weighted-Average Strike Price |
|
|
Weighted-Average Time to Maturity |
|
|||
Liability Classified Warrants |
|
|
|
|
|
|
|
|
|
|||
Investor D Warrants |
|
|
|
|
$ |
|
|
|
|
|||
Private Placement Warrants |
|
|
|
|
$ |
|
|
|
|
|||
PIPE Investor Warrants |
|
|
|
|
$ |
|
|
|
|
|||
|
|
|
|
|
|
|
|
|
|
|||
Equity Classified Warrants |
|
|
|
|
|
|
|
|
|
|||
Public Stockholders' Warrants |
|
|
|
|
$ |
|
|
|
|
|||
Legacy SeaStar Inc. Warrants |
|
|
|
|
$ |
|
|
|
|
Below is the warrant activity for the period ended March, 31, 2024:
11
Notes to the Unaudited Condensed Consolidated Financial Statements
(in thousands, except for shares and per-share amounts)
|
|
Investor D Warrants |
|
|
Investor E Warrants |
|
|
Placement Agent Warrants |
|
|
Private Placement Warrants |
|
|
PIPE Investor Warrants |
|
|
Public Stockholders' Warrants |
|
|
Legacy Warrants |
|
|||||||
Outstanding as of December 31, 2023 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||
Issuance |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||
Exercised |
|
|
( |
) |
|
|
( |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||
Forfeited / cancelled |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||
Outstanding as of March 31, 2024 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
During the quarter-ended March 31, 2024, the Company incurred $
`
Note 8. Stock-Based Compensation Awards
The following table sets forth the total stock-based compensation cost included in the Company's condensed consolidated statements of operations for the period indicated:
Hi, I am hiring for my 9* logistics company. If interested, please send working stats and # of EE merits. Thank you!
|
|
|
|
Three Months Ended March 31, |
|
|||||||
($ in thousands) |
|
|
|
|
|
2024 |
|
|
2023 |
|
||
Research and development |
|
|
|
|
|
$ |
|
|
$ |
|
||
General and administrative |
|
|
|
|
|
|
|
|
|
|
||
Total stock-based compensation |
|
|
|
|
|
$ |
|
|
$ |
|
Equity incentive plan - summary
2022 Omnibus Incentive Plan
The Company's Board of Directors adopted, and the shareholders approved the 2022 Omnibus Incentive Plan to provide long-term incentive for its employees and non-employee service providers. The vesting of stock options is stated in each individual grant agreement, which is generally either or
2019 Stock Incentive Plan
The Company’s Board of Directors adopted the 2019 Stock Incentive Plan on February 25, 2019, to provide long-term incentive for its employees and non-employee service providers. The Stock Incentive Plan was terminated on October 28, 2022, and no further awards were granted under such plan.
Equity incentive plan - stock options
12
Notes to the Unaudited Condensed Consolidated Financial Statements
(in thousands, except for shares and per-share amounts)
Option activity for the periods ended March 31, 2024, is as follows:
2022 Omnibus Incentive Plan - Options
|
|
|
|
Options |
|
|
Weighted-Average Exercise Price |
|
|
Total Intrinsic Value |
|
|
Weighted-Average Remaining Contractual Life (Years) |
|
||||
Outstanding at December 31, 2023 |
|
|
|
|
|
|
$ |
|
|
$ |
|
|
|
|
||||
Exercised |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Issued |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Forfeited / cancelled |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Outstanding at March 31, 2024 |
|
|
|
|
|
|
$ |
|
|
$ |
|
|
|
|
||||
Vested and exercisable at March 31, 2024 |
|
|
|
|
|
|
$ |
|
|
$ |
|
|
|
|
2019 Omnibus Incentive Plan - Options
|
|
|
|
Options |
|
|
Weighted-Average Exercise Price |
|
|
Total Intrinsic Value |
|
|
Weighted-Average Remaining Contractual Life (Years) |
|
||||
Outstanding at December 31, 2023 |
|
|
|
|
|
|
$ |
|
|
$ |
|
|
|
|
||||
Exercised |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Issued |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Forfeited / cancelled |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Outstanding at March 31, 2024 |
|
|
|
|
|
|
$ |
|
|
$ |
|
|
|
|
||||
Vested and exercisable at March 31, 2024 |
|
|
|
|
|
|
$ |
|
|
$ |
|
|
|
|
Equity incentive plan - restricted stock units
A summary of the Company’s restricted stock unit (‘RSU”) activity is as follows:
2022 Omnibus Incentive Plan - RSUs
|
|
|
|
Number of RSU |
|
|
Weighted-Average Grand Date Fair Value (per share) |
|
||
Outstanding at December 31, 2023 |
|
|
|
|
|
|
$ |
|
||
Granted |
|
|
|
|
|
|
|
|
||
Vested |
|
|
|
|
|
|
|
|
||
Forfeited / cancelled |
|
|
|
|
|
|
|
|
||
Outstanding at March 31, 2024 |
|
|
|
|
|
|
$ |
|
13
Notes to the Unaudited Condensed Consolidated Financial Statements
(in thousands, except for shares and per-share amounts)
2019 Stock Incentive Plan - RSUs
|
|
|
|
Number of RSU |
|
|
Weighted-Average Grand Date Fair Value (per share) |
|
||
Outstanding at December 31, 2023 |
|
|
|
|
|
|
$ |
|
||
Exercised |
|
|
|
|
|
|
|
|
||
Vested |
|
|
|
|
( |
) |
|
|
|
|
Forfeited / cancelled |
|
|
|
|
|
|
|
|
||
Outstanding at March 31, 2024 |
|
|
|
|
|
|
$ |
|
Note 9. Commitments and Contingencies
License and distribution agreement
On December 27, 2022, the Company entered into a license and distribution agreement (“License Agreement”) with a distributor, appointing the distributor as the exclusive distributor to promote, advertise, market, distribute and sell the Selective Cytopheretic Device (“SCD”) in the United States. The Company received an upfront payment of $
Lease agreements
The Company is part of a membership agreement for shared office space and can cancel at any time. Rent expense was approximately $
Litigation
Liabilities for loss contingencies arising from claims, assessments, litigation, fines, penalties, and other sources are recorded when it is probable that a liability has been incurred and the amount can be reasonably estimated. From time to time, the Company may become involved in legal proceedings arising in the ordinary course of business.
In connection with the Business Combination, LMAO proposed, for stockholder approval, various amendments to its Amended and Restated Certificate of Incorporation, which included among other things a proposal to increase the authorized shares of common stock. A purported stockholder sent a Stockholder Litigation Demand letter (the “Demand”) to the Board of Directors of LMAO alleging that the Delaware General Corporation Law required a separate class vote of the Class A common stockholders to increase the authorized shares of common stock. Following receipt of the Demand, the Company canceled and withdrew the proposal to increase the authorized shares of common stock.
The stockholder’s counsel thereafter demanded that the Company pay counsel fees for the purported benefit conferred upon the Company’s shareholders by causing the Company to withdraw the allegedly invalid proposal to increase the authorized shares of common stock. The Company paid approximately $
14
Notes to the Unaudited Condensed Consolidated Financial Statements
(in thousands, except for shares and per-share amounts)
Note 10. Fair Value Measurements
Fair value is defined as the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date (exit price). Inputs used to measure fair value are classified into the following hierarchy:
Level 1 – quoted prices in active markets for identical assets and liabilities.
Level 2 – other significant observable inputs (including quoted prices for similar assets and liabilities, interest rate, credit risk, etc.).
Level 3 – significant unobservable inputs (including the Company’s own assumptions in determining the fair value of assets and liabilities).
The fair value of the forward option on prepaid forward contracts, convertible notes, and the warrants liability is classified as Level 3 in the fair value hierarchy.
Fair Value Measurement Hierarchy
The following table presents the Company's financial assets and/or liabilities that were accounted for at fair value on a recurring basis as of March 31, 2024 and December 31, 2023, by level withing the fair value hierarchy. There were no non-recurring fair value measurements, as the Company does not have any long-lived assets, including fixed assets, intangible assets or goodwill which can require non-recurring measurements for impairment.
|
|
Fair Value Measurements at March 31, 2024 |
|
|||||||||||||
|
|
(Level 1) |
|
|
(Level 2) |
|
|
(Level 3) |
|
|
Total |
|
||||
Liabilities: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Convertible notes |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
Liability classified warrants |
|
|
|
|
|
|
|
|
|
|
|
|
||||
|
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
|
|
Fair Value Measurements at December 31, 2023 |
|
|||||||||||||
|
|
(Level 1) |
|
|
(Level 2) |
|
|
(Level 3) |
|
|
Total |
|
||||
Liabilities: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Convertible notes |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
Liability classified warrants |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Total |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
Summary of Level 3 Input Changes
The following table presents the changes in the forward option-prepaid forward contracts, convertible notes measured at fair value, warrants liability, and the notes derivative liability for the periods ended March 31, 2024 and December 31, 2023 (in thousands):
Level 3 Roll Forward |
|
|
Convertible Notes |
|
|
Liability Classified Warrants |
|
|
|
||
Balance December 31, 2023 |
|
|
$ |
|
|
$ |
|
|
|
||
Additions |
|
|
|
|
|
|
|
|
|
||
Cash paid to settle |
|
|
|
|
|
|
|
|
|
||
Shares issued upon conversion or exercise |
|
|
|
( |
) |
|
|
( |
) |
|
|
Changes in fair value |
|
|
|
|
|
|
|
|
|
||
Balance March 31, 2024 |
|
|
$ |
|
|
$ |
|
|
|
15
Notes to the Unaudited Condensed Consolidated Financial Statements
(in thousands, except for shares and per-share amounts)
Level 3 Inputs
For assets or liabilities for which the Company is required to remeasure the fair value on a recurring basis at each reporting date, generally the Company is required to disclose certain quantitative data related to the inputs used at the most recent reporting period date. However, for those assets or liabilities for which the Company has elected to take the FVO in accordance with ASC 825, Financial Instruments, then such quantitative disclosures are not required.
Liability Classified Warrants
The liability classified warrants as of March 31, 2024 and December 31, 2023, include three classes of warrants, and therefore, the range of assumptions used has been provided. Significant assumptions used in valuing warrants which require liability classification were as follows as of March 31, 2024 and December 31, 2023.
|
|
March 31, 2024 |
|
||||||
|
|
Minimum |
|
|
|
Maximum |
|
||
Expected volatility |
|
|
% |
|
|
|
% |
||
Equivalent term (#) |
|
|
|
|
|
|
|
||
Risk-free rate |
|
|
% |
|
|
|
% |
||
Dividend yield |
|
|
% |
|
|
|
% |
||
Stock price |
$ |
|
|
|
$ |
|
|
||
Strike price (#) |
$ |
|
|
|
$ |
|
|
|
|
December 31, 2023 |
|
||||||
|
|
Minimum |
|
|
|
Maximum |
|
||
Expected volatility |
|
|
% |
|
|
|
% |
||
Equivalent term |
|
|
|
|
|
|
|
||
Risk-free rate |
|
|
% |
|
|
|
% |
||
Dividend yield |
|
|
% |
|
|
|
% |
||
Stock price |
$ |
|
|
|
$ |
|
|
||
Strike price |
$ |
|
|
|
$ |
|
|
Note 11. Income Taxes
In accordance with U.S. GAAP, a valuation allowance should be provided if it is more likely than not that some or all of the Company’s deferred tax assets will not be realized. The Company’s ability to realize the benefit of its deferred tax assets will depend on the generation of future taxable income. Due to the uncertainty of future profitable operations and taxable income, the Company has recorded a full valuation allowance against its net deferred tax assets. The Company believes its tax filing position and deductions related to tax periods subject to examination will be sustained under audit and, therefore, has no reserve for uncertain tax positions.
Note 12. Net Loss Per Share
The following table presents the calculation of basic and diluted net loss per share (in thousands except share and per share information):
|
|
|
Three Months Ended March 31, |
|
||||||
|
|
|
|
2024 |
|
|
2023 |
|
||
Net loss |
|
|
|
$ |
( |
) |
|
$ |
( |
) |
Weighted-average shares outstanding - basic and diluted |
|
|
|
|
|
|
|
|
||
Basic and diluted net loss per share |
|
|
|
$ |
( |
) |
|
$ |
( |
) |
16
Notes to the Unaudited Condensed Consolidated Financial Statements
(in thousands, except for shares and per-share amounts)
The following weighted-average outstanding shares of potentially dilutive securities were excluded from the computation of diluted net loss per share attributable to common stockholders for the periods presented because including them would have been anti-dilutive:
|
|
|
|
As of March 31, |
|
|||||||
|
|
|
|
|
|
2024 |
|
|
2023 |
|
||
Investor D warrants |
|
|
|
|
|
|
|
|
|
|
||
Investor E warrants |
|
|
|
|
|
|
|
|
|
|
||
Placement Agent warrants |
|
|
|
|
|
|
|
|
|
|
||
Public Stockholders' warrants |
|
|
|
|
|
|
|
|
|
|
||
Private Placement warrants |
|
|
|
|
|
|
|
|
|
|
||
PIPE Investor warrants |
|
|
|
|
|
|
|
|
|
|
||
Legacy warrants |
|
|
|
|
|
|
|
|
|
|
||
Employee based options to purchase common stock |
|
|
|
|
|
|
|
|
|
|
||
Unvested employee based restricted stock units |
|
|
|
|
|
|
|
|
|
|
||
Total |
|
|
|
|
|
|
|
|
|
|
Note 13. Subsequent Events
Investor D April 2024 Side Letter
On April 1, 2024, the Company and Investor D entered into the a side letter agreement (the "April 2024 Side Letter") whereby each party agreed to suspend certain rights of Investor D for a
17
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations.
The following discussion and analysis are intended to help you understand our business, financial condition, results of operations, liquidity, and capital resources. You should read this discussion in conjunction with the Company’s consolidated financial statements and related notes included elsewhere in this Form 10-Q and in our Annual Report on Form 10-K for the year ended December 31, 2023.
In addition to historical financial analysis, this discussion and analysis contains forward-looking statements based upon current expectations that involve risks, uncertainties, and assumptions, as described under the heading “Cautionary Note Regarding Forward Looking Statements.” Actual results and timing of selected events may differ materially from those anticipated in these forward-looking statements as a result of various factors, risks and uncertainties, including those set forth under “Risk Factors” included elsewhere (or incorporated by reference) in this Form 10-Q and in our Annual Report on Form 10-K for the year ended December 31, 2022. Unless the context otherwise requires, references in this “Management’s Discussion and Analysis of Financial Condition and Results of Operations” to “SeaStar Medical", “we", “us", “our,” and “the Company” are intended to mean the business and operations of SeaStar Medical Holding Corporation and its consolidated subsidiaries following the Business Combination.
Overview
On October 28, 2022, LMAO consummated a series of transactions that resulted in the combination of LMF Merger Sub, Inc. and SeaStar Medical, Inc. pursuant to an Agreement and Plan of Merger (the "Business Combination").
The Company is a medical technology company developing a platform therapy to reduce the consequences of hyperinflammation on vital organs. In a normal inflammatory response, neutrophils are the first immune cells to arrive at the site and are key to the entire immune response that kills pathogens and promotes tissue repair. If the inflammatory response becomes excessive and dysregulated, normal neutrophil die off may be delayed, altering feedback mechanisms that regulate the immune system. This results in damaging hyperinflammation spreading uncontrollably to other parts of the body, often leading to acute chronic solid organ dysfunction or failure, including heart, lung, kidney and liver diseases. This hyperinflammatory response is also known as the cytokine storm, referring to the body’s reaction to the category of small-secreted proteins released by hyperinflammatory cells that affect communication between cells. The cytokine storm, when left uncontrolled, can lead to organ damage and even death.
We are initially using our proprietary Selective Cytopheretic Device (“SCD”) technology platform to clinically validate several acute organ injury indications, including kidneys and lungs. Our investigational SCD is an extracorporeal synthetic membrane device designed to be easily integrated into existing Continuous Renal Replacement Therapy ("CRRT") systems that are commonly installed in hospitals, including in Intensive Care Units throughout the United States. Once approved and commercialized, the SCD would initially target acute kidney injury in both the pediatric CRRT population as well as adults on CRRT. In addition, we are developing our SCD to address inflammation associated with chronic dialysis and chronic heart failure. The regulatory approval process for our SCD product candidates is costly and involves significant risks and uncertainties. For a detailed description of these and other risks, please see “Risk Factors” under Part II, Item I of this Form 10-Q.
We have incurred net losses in each year since our inception in 2007. As of March 31, 2024 and December 31, 2023, we had an accumulated deficit of $127.4 million and $114.7 million, respectively. Our net losses were $12.7 million and $7.1 million for the three months ended March 31, 2024 and 2023, respectively. Substantially all our net losses resulted from costs incurred in connection with our research and development programs and from general and administrative costs associated with our operations.
As of March 31, 2024 and December 31, 2023, we had cash of $5.0 million and $0.2 million, respectively.
Our accompanying unaudited consolidated financial statements have been prepared on a going concern basis, which contemplates the realization of assets and liabilities in the normal course of business. Our consolidated financial statements do not include any adjustments relating to the recoverability and classification of asset amounts or the classification of liabilities that might be necessary should the Company be unable to continue as a going concern.
The recurring losses, working capital deficiency, the need for capital to fund our operations, including clinical trial and regulatory approval expenses, and the amount of cash reserve are factors that raise substantial doubt about our ability to continue as a going concern for the twelve-month period from the date the unaudited consolidated financial statements are made available. See Note 1 to our unaudited consolidated financial statements for the three months ended March 31, 2024 included elsewhere in this Form 10-Q for additional information on our assessment.
Our need for additional capital will depend in part on the scope and costs of our development activities. To date, we have not generated any significant revenue from the sale of commercialized products. Our ability to generate product revenue will depend on the successful development and eventual commercialization of our products. Until such time, if ever, we expect to finance our operations through the sale of equity or debt, borrowings under credit facilities, potential collaborations, other strategic transactions or government and other grants. Adequate capital may not be available to us when needed or on acceptable terms. If we are unable to raise capital, we could be forced to delay, reduce, suspend or cease our research and development programs or any future commercialization efforts,
18
which would have a negative impact on our business, prospects, operating results and financial condition. See Part I, Item 1A “Risk Factors” for additional information.
Key Components of Results of Operations
Revenue
To date, we have not generated any revenue from the sale of commercialized products. Our pediatric SCD received HDE approval from the Food and Drug Administration (the "FDA") in February 2024, and we expect to commercialize the product in the near term. Revenue has been primarily derived from government and other grants. We may generate revenue in the future based on payments from license or collaboration agreements and government and other grants, and, from product sales of our pediatric SCD. We expect that any revenue we generate will fluctuate from quarter to quarter. We also continue to develop our adult SCD product for which we are pursuing FDA approval. If we fail to complete the development of or obtain regulatory approval for commercialization of our adult SCD products in a timely manner, our ability to generate future revenue and our results of operations and financial position, would be materially adversely affected.
Research and Development Expenses
Since our inception, we have focused our resources on our research and development activities, including conducting preclinical studies and clinical trials, and developing our process and activities related to regulatory filings for our products. Subject to the availability of additional funding, we plan to further increase our research and development expenses for the foreseeable future as we continue the development of our products.
General and Administrative Expenses
General and administrative expenses consist primarily of salaries and related costs for employees in executive and finance roles, which also include stock-based compensation expenses and benefits for such employees.
Other significant general and administrative expenses include facilities costs, professional fees for accounting and legal services and expenses associated with obtaining and maintaining patents and obtaining financing. As we continue to expand and grow our operations, we expect that our general and administrative expenses will increase, including additional expenses relating to new hires, travel, a new enterprise resource planning platform, and branding.
Other Income (Expense), Net
Total other income (expense), net primarily consists of interest expense relating to interest incurred on our notes, interest incurred on our convertible notes, change in the fair value of warrants liability, change in fair value of convertible notes, gain on issuance of convertible notes, change in fair value of forward-option forward contracts, and gain on sale of recycled shares.
Net Loss
Net loss consists of the Company’s loss from operations, less other expense.
Factors Affecting the Company’s Operating Results
We believe that our performance and future success depend on a number of factors that present significant opportunities for us but also pose risks and challenges. Please see the factors discussed elsewhere in this Form 10-Q, including those discussed in Part I, Item 1A, “Risk Factors,” for additional information.
Results of Operations
Comparison of the Three Months Ended March 31, 2024 to the Three Months Ended March 31, 2023
The following table sets forth a summary of our results of operations. This information should be read together with our unaudited consolidated financial statements and related Notes included elsewhere in this Form 10-Q.
19
|
|
|
Three Months Ended |
|
|
|
|
|
|
|
|
||||||||
|
|
|
March 31, |
|
|
|
Change |
|
|||||||||||
($ in thousands) |
|
|
2024 |
|
|
|
2023 |
|
|
|
$ |
|
|
% |
|
||||
Revenue |
|
|
$ |
— |
|
|
|
$ |
— |
|
|
|
$ |
— |
|
|
|
— |
|
Operating expenses |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Research and development |
|
|
|
1,697 |
|
|
|
|
1,730 |
|
|
|
|
(33 |
) |
|
|
(2 |
)% |
General and administrative |
|
|
|
2,253 |
|
|
|
|
2,851 |
|
|
|
|
(598 |
) |
|
|
(21 |
)% |
Total operating expenses |
|
|
|
3,950 |
|
|
|
|
4,581 |
|
|
|
|
(631 |
) |
|
|
(14 |
)% |
Loss from operations |
|
|
|
(3,950 |
) |
|
|
|
(4,581 |
) |
|
|
|
631 |
|
|
|
(14 |
)% |
Total other income (expense) |
|
|
|
(8,747 |
) |
|
|
|
(2,515 |
) |
|
|
|
(6,232 |
) |
|
|
248 |
% |
Loss before income tax provision |
|
|
|
(12,697 |
) |
|
|
|
(7,096 |
) |
|
|
|
(5,601 |
) |
|
|
79 |
% |
Income tax provision (benefit) |
|
|
|
— |
|
|
|
|
— |
|
|
|
|
— |
|
|
|
— |
|
Net loss |
|
|
$ |
(12,697 |
) |
|
|
$ |
(7,096 |
) |
|
|
$ |
(5,601 |
) |
|
|
79 |
% |
Research and Development Expenses
The following table discloses the breakdown of research and development expenses:
|
|
|
Three Months Ended |
|
|
|
|
|
|
|
|
||||||||
|
|
|
March 31, |
|
|
|
Change |
|
|||||||||||
($ in thousands) |
|
|
2024 |
|
|
|
2023 |
|
|
|
$ |
|
|
% |
|
||||
Clinical trials |
|
$ |
|
613 |
|
|
|
|
550 |
|
|
$ |
|
63 |
|
|
|
11 |
% |
External services |
|
|
|
345 |
|
|
|
|
549 |
|
|
|
|
(204 |
) |
|
|
(37 |
)% |
Payroll and personnel expenses |
|
|
|
690 |
|
|
|
|
568 |
|
|
|
|
122 |
|
|
|
21 |
% |
Other research and development expenses |
|
|
|
49 |
|
|
|
|
63 |
|
|
|
|
(14 |
) |
|
|
(22 |
)% |
|
|
$ |
|
1,697 |
|
|
$ |
|
1,730 |
|
|
$ |
|
(33 |
) |
|
|
(2 |
)% |
Research and development expenses for the three months ended March 31, 2024 and 2023 were $1.7 million and $1.7 million, respectively. The slight decrease in research and development expenses of less than $0.1 million, or 2%, was primarily driven by (i) a decrease in the use of external services of $0.1 million, driven by a reduction in the amount of focus on the design of the technology, and (ii) a reduction in other expenses of less than $0.1 million, due to a reduction in patent fees. This was offset by (i) increases in clinical trial expenses of $0.1 million, and (ii) an increase in payroll and personnel expenses of $0.1 million, as the Company began to increase its clinical trial activity in order to gain future regulatory approvals.
General and Administrative Expenses
General and administrative expenses for the three months ended March 31, 2024 and 2023 were $2.3 million and $2.9 million, respectively. The decrease in general and administrative expenses of approximately $0.6 million was driven by a reduction in (i) $0.2 million reduction in accounting, finance, legal and SEC related fees, as the extension of the Form 10-K filing into April of 2024, moved some efforts into the second quarter of 2024 including proxy related costs, (ii) $0.1 million reduction in sales and marketing expenses, (iii) $0.1 million reduction in insurance fees, (iv) $0.1 million in other related business expenses driven mostly by a legal settlement in Q1 2023, and (v) $0.1 million reduction due to a combination of slightly lower personnel costs and use of third-party consultants during the first quarter of 2024.
Other Income (Expense)
Other expenses increased approximately $6.2 million, or 248% for the three months ended March 31, 2024, compared to the three months ended March 31, 2023. The key drivers for this increase was (i) a $4.6 million loss on the extinguishment of convertible notes, due to the fair value of the common stock issued in excess of the fair value of the underlying note; (ii) $2.8 million loss on the change in the fair value of liability classified warrants, whether exercised or outstanding at March 31, 2024, a (iii) $0.7 million loss on issuance of convertible notes, as a result of the fair value of the convertible notes exceeding the proceeds received from the investor, net of the fair value of detachable warrants and (iv) a $0.4 million loss on the increase in the fair value of convertible notes. This was offset by (i) the company recognized a $2.2 million dollar loss on a forward purchase agreement derivative liability at March 31, 2023, which no longer exists in 2024, and (ii) $0.3 million reduction in interest expense as a result of both paying down notes payable and converting all but $1.1 million in convertible notes at March 31, 2024.
20
Income Tax Provision (Benefit)
SeaStar Medical recorded a provision for income taxes of $0.0 million for the three months ended March 31, 2024, and a provision for income taxes of $0.0 million for the three months ended March 31, 2023.
Under Accounting Standards Codification (“ASC”) 740-10-30-5, Income Taxes, deferred tax assets should be reduced by a valuation allowance if, based on the weight of available evidence, it is more-likely-than-not (i.e., a likelihood of more than 50%) that some portion or all of the deferred tax assets will not be realized. SeaStar Medical considers all positive and negative evidence available in determining the potential realization of deferred tax assets including, primarily, the recent history of taxable earnings or losses. Based on operating losses reported during 2022 and 2021, the Company concluded there was not sufficient positive evidence to overcome this recent operating history. As a result, we believe that a valuation allowance continues to be necessary based on the more-likely-than-not threshold noted above.
Net Loss
During the three months ended March 31, 2024, SeaStar Medical had a net loss of $12.7 million compared to a net loss of $7.1 million for the three months ended March 31, 2023. The increased net loss of $5.6 million has been disclosed in the above discussion.
Liquidity and Capital Resources
Sources of Liquidity
To date, we have financed our operations primarily through the sale of equity securities and convertible debt and, to a lesser extent, through grants from governmental and other agencies. Since our inception, we have incurred significant operating losses and negative cash flows. As of March 31, 2024 and December 31, 2023, we had an accumulated deficit of $127.4 million and $114.7 million, respectively.
As of March 31, 2024 and December 31, 2023, we had cash of $5.0 million and $0.2 million, respectively. We expect that our existing cash will be insufficient to fund our operations, including clinical trial expenses and capital expenditure requirements. We believe that this raises doubt about our ability to continue as a going concern. To finance our operations beyond that point, we would need to raise additional capital, and there is no guarantee that we will be able to secure additional funding on favorable terms, or at all. We have concluded that these circumstances raise doubt about our ability to continue as a going concern within one year after the issuance date of this Form 10-Q. See Note 1 to our unaudited condensed consolidated financial statements for the period ended March 31, 2024.
We would receive the proceeds from any exercise of any warrants that are exercised for cash pursuant to their terms. Assuming the exercise in full of all of the warrants for cash, we would receive an aggregate of approximately $16.2 million, but would not receive any proceeds from the sale of the shares of common stock issuable upon such exercise. To the extent any warrants are issued on a “cashless basis,” the amount of cash we would receive from the exercise of the warrants will decrease. We would expect to use any such proceeds received from warrants that are exercised for cash in the future for general corporate and working capital purposes, which would increase our liquidity. However, we will only receive such proceeds if and when the warrant holders exercise the warrants. The exercise of the warrants, and any proceeds we may receive from their exercise, are highly dependent on the price of our common stock and the spread between the exercise price of the warrant and the price of our common stock at the time of exercise. There is no assurance that the warrant holders will elect to exercise for cash any or all of such warrants, and we believe that any such exercise currently is unlikely to occur as described below. As of the date of this Annual Report, we have neither included nor intend to include any potential cash proceeds from the exercise of our warrants in our short-term or long-term liquidity projections. We will continue to evaluate the probability of warrant exercise over the life of our warrants and the merit of including potential cash proceeds from the exercise in our liquidity projections.
We do not expect to rely on the cash exercise of warrants to fund our operations. Instead, we intend to rely on our primary sources of cash discussed elsewhere in this Form 10-Q to continue to support our operations. Accordingly, we believe that it is currently unlikely that warrant holders will exercise their warrants. The likelihood that warrant holders will exercise the warrants, and therefore the amount of cash proceeds that we would receive, is dependent upon the trading price of our common stock. If the trading price for our common stock remains less than $0.8302 per share, we believe our warrant holders will be unlikely to exercise their warrants. There is no guarantee that the warrants will be in the money following the time they become exercisable and prior to their expiration, and as such, the warrants may expire worthless, and we may not receive any proceeds from the exercise of the warrants. To the extent that any of the warrants are exercised on a “cashless basis,” the amount of cash we would receive from the exercise of the warrants will decrease.
Future Funding Requirements
21
We expect to incur significant expenses in connection with our ongoing activities as we seek to (i) continue clinical development of our adult SCD product for approval by the FDA, and (ii) if regulatory approval is obtained, to launch and commercialize our adult SCD product in the U.S. market, including subsequent launches in key international markets. We will need additional funding in connection with these activities. Our future funding requirements, both short-term and long-term, will depend on many factors, including:
Until such time, if ever, as we are able to successfully develop and commercialize our products, we expect to continue financing our operations through the sale of equity, debt, borrowings under credit facilities or through potential collaborations with other companies, other strategic transactions or government or other grants. Adequate capital may not be available to us when needed or on acceptable terms.
Based on our results of operations and liquidity as of March 31, 2024, we believe our cash and cash equivalents, including the cash we obtained from the Q1 2024 SPA registered direct financing are not sufficient to meet our working capital and capital expenditure requirements for a period of at least twelve months from the date of our unaudited consolidated financial statements for the three months ended March 31, 2024, are made available. In addition, we do not expect to receive any cash proceeds from the exercise of warrants in the near term, because the trading price of our common stock is currently below the exercise price of such warrants. We are seeking additional cash to fund our growth through future debt or equity financing transactions; however, there can be no assurance that we will be able to obtain additional capital on terms acceptable to us, if at all, or that we will generate sufficient future revenues and cash flows to fund our operations. Our estimates of our results of operations, working capital and capital expenditure requirements may be different than our actual needs, and those estimates may need to be revised if, for example, our actual revenue is lower, and our net operating losses are higher, than we project, and our cash and cash equivalents position is reduced faster than anticipated. We do not currently have any committed external source of funds.
To the extent that we raise additional capital through the sale of equity or convertible debt securities, the ownership interest of our stockholders will be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect the rights of stockholders. Debt financing and preferred 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 acquisitions or capital expenditures. Debt financing would also result in fixed payment obligations. If we are unable to raise additional funds through equity or debt financings or other arrangements when needed, we may be required to delay, reduce, suspend or cease our research and development programs or any future commercialization efforts, which would have a negative impact on our business, prospects, operating results, and financial condition. See the section titled “Risk Factors” for additional risks associated with our substantial capital requirements.
Cash Flows
The following table shows a summary of our cash flows for each of the periods shown below:
Cash Flow from Operating Activities
|
|
Three Months Ended |
|
|||||
|
|
March 31, |
|
|||||
($ in thousands) |
|
2024 |
|
|
2023 |
|
||
Statement of cash flow data: |
|
|
|
|
|
|
||
Total cash (used in)/provided by: |
|
|
|
|
|
|
||
Operating activities |
|
$ |
(3,488 |
) |
|
$ |
(2,294 |
) |
Investing activities |
|
|
— |
|
|
|
— |
|
Financing activities |
|
|
8,331 |
|
|
|
2,972 |
|
|
|
$ |
4,843 |
|
|
$ |
678 |
|
22
Net cash used in operating activities for the three months ended March 31, 2024 was $3.5 million compared to $2.3 million for the three months ended March 31, 2023. The increase in cash used for operating activities of $1.2 million is primarily due to the timing of certain payments to vendors, reducing our outstanding payables, as a result cash provided by financing activities as discussed below.
Net cash provided by financing activities for the three months ended March 31, 2024 was $8.3 million, primarily related to the issuance of new shares of common stock, proceeds from exercise of warrants, and the avoidance of certain principal payments due to the conversion of certain convertible notes. Cash provided by financing activities for the three months ended March 31, 2023 was $3.0 million, primarily from the issuance of notes payable.
Critical Accounting Policies and Estimates
The preparation of the unaudited consolidated financial statements and related disclosures in conformity with U.S. GAAP requires management to make estimates, assumptions and judgments that affect the reported amounts of assets and liabilities, disclosure of contingent assets and liabilities at the date of the consolidated financial statements, and income and expenses during the periods reported. Although actual results could materially differ from those estimates, such estimates are developed based on the best information available to management and management's best judgments at the time.
There has been no material change from the policies or methods disclosed in our Annual Report to Form 10-K filed April 16, 2024, as amended by Form 10-K/A filed April 26, 2024, for the year-ended December 31, 2023.
Emerging Growth Company Status
We are an emerging growth company (“EGC”), as defined in the Jumpstart Our Business Startups (“JOBS”) Act. The JOBS Act permits companies with EGC status to take advantage of an extended transition period to comply with new or revised accounting standards, delaying the adoption of these accounting standards until they apply to private companies. We have elected to use this extended transition period to enable us to comply with new or revised accounting standards that have different effective dates for public and private companies until the earlier of the date we (i) are no longer an emerging growth company or (ii) affirmatively and irrevocably opt out of the extended transition period provided in the JOBS Act. As a result, our consolidated financial statements may not be comparable to companies that comply with the new or revised accounting standards as of public company effective dates.
In addition, we intend to rely on the other exemptions and reduced reporting requirements provided by the JOBS Act. Since we intend to rely on such exemptions, we are not required to, among other things: (i) provide an auditor’s attestation report on our system of internal controls over financial reporting pursuant to Section 404(b) of the Sarbanes-Oxley Act; (ii) provide all of the compensation disclosure that may be required of non-emerging growth public companies under the Dodd-Frank Wall Street Reform and Consumer Protection Act; (iii) comply with any requirement that may be adopted by the Public Company Accounting Oversight Board regarding mandatory audit firm rotation or a supplement to the auditor’s report providing additional information about the audit and the consolidated financial statements (auditor discussion and analysis); and (iv) disclose certain executive compensation-related items such as the correlation between executive compensation and performance and comparisons of the Chief Executive Officer’s compensation to median employee compensation.
We will remain an EGC under the JOBS Act until the earliest of (i) the last day of our first fiscal year following the fifth anniversary of the closing of this the Business Combination, (ii) the last date of our fiscal year in which we have total annual gross revenue of at least $1.07 billion, (iii) the date on which we are deemed to be a “large-accelerated filer” under the rules of the SEC with at least $700.0 million of outstanding securities held by non-affiliates, or (iv) the date on which we have issued more than $1.0 billion in non-convertible debt securities during the previous three-years.
Contractual Obligations and Commitments
The following table summarizes our contractual obligations as of March 31, 2024:
|
|
Total |
|
|
Less than |
|
|
1-3 years |
|
|
3-5 years |
|
|
More than |
|
|||||
Contractual Obligations: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||
LMFA note payable |
|
$ |
— |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
— |
|
LMFAO note payable |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
Maxim note payable |
|
|
2,565 |
|
|
|
— |
|
|
|
2,565 |
|
|
|
— |
|
|
|
— |
|
Convertible Notes |
|
|
918 |
|
|
|
918 |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
Insurance Financing |
|
|
357 |
|
|
|
357 |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
Total contractual obligations |
|
$ |
3,840 |
|
|
$ |
1,275 |
|
|
$ |
2,565 |
|
|
$ |
— |
|
|
$ |
— |
|
23
Recent Developments
In April of 2024, the Company was included as part of a consortium with various research institutions as part of a National Institute for Health ("NIH") National Heart, Lung, and Blood Institute has awarded a $3.6 million grant, of which SeaStar expects to receive a portion, for serving as a contract research organization for the clinical trial, to evaluate the Selective Cytopheretic Device Adult (SCD-ADULT, a member of the Company’s Quelimmune product family). SCD-Adult is a potential bridging strategy to left ventricular assist device (LVAD) implantation in patients with chronic heart failure (CHF) who have progressed to acute decompensated heart failure (ADHF). This grant award follows a Breakthrough Device Designation for cardiorenal syndrome granted by the FDA's Center for Biologics Evaluation and Research (CBER) in September 2023. With current standard of care treatment, ADHF can accelerate worsening renal function in a feedback loop known as cardiorenal syndrome, which is associated with a poor prognosis. These patients are often ineligible for lifesaving LVAD implantation due to the severity of their condition. This grant was awarded to Innovative BioTherapies (IBT), which is led by SCD inventor H. David Humes, M.D., Professor, Division of Nephrology, Internal Medicine, University of Michigan and SeaStar Medical Scientific Advisor.
Item 3. Quantitative and Qualitative Disclosures About Market Risk.
We are a smaller reporting company as defined by Rule 12b-2 of the Exchange Act and are not required to provide the information required under this item.
Item 4. Controls and Procedures.
This Item 4 includes information concerning the controls and controls evaluation referred to in the certifications of our Chief Executive Officer and Chief Financial Officer required by Rule 13a-14 of the Exchange Act included in this Form 10-Q as Exhibits 31.1 and 31.2.
Evaluation of Disclosure Controls and Procedures
Our management, including our Chief Executive Officer and Chief Financial Officer, evaluated as of the effectiveness of our disclosure controls and procedures (as defined in Rule 13a-15(e) under the Securities Exchange Act of 1934, as amended (the “Exchange Act”)) as of March 31, 2024 and based on this evaluation, have concluded that, as a result of the material weaknesses in internal control over financial reporting as described below, our disclosure controls and procedures were not effective as of March 31, 2024.
Pursuant to Rule 13a-15(e), the term “disclosure controls and procedures” means controls and other procedures of an issuer that are designed to ensure that information required to be disclosed by the issuer in the reports that it files or submits under 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 by an issuer in the reports that it files or submits under the Exchange Act is accumulated and communicated to the issuer’s management, including its Chief Executive Officer and Chief Financial Officer, or persons performing similar functions, as appropriate to allow timely decisions regarding required disclosure.
Material Weaknesses
A material weakness is a deficiency, or combination of deficiencies, in internal control over financial reporting such that there is a reasonable possibility that a material misstatement of our annual or interim financial statements will not be prevented or detected on a timely basis.
In the course of preparing the audited consolidated financial statements as of and for the year-ended December 31, 2023, our management identified material weaknesses in its internal controls over financial reporting related to a deficiency in the design and operation of our financial accounting and reporting controls.
To help address the material weaknesses, we have strengthened our accounting team with the addition of an experienced Controller and Chief Financial Officer and have identified additional accounting resources that are expected to help to remediate the material weaknesses. We will also continue to review the overall internal control environment as we develop the requisite internal control framework. While we believe these efforts will remediate the material weakness, the material weakness cannot be considered fully remediated until the applicable remedial controls operate for a sufficient period of time and management has concluded, through testing, that these controls are operating effectively.
24
Changes in Internal Control over Financial Reporting
Except for the changes intended to remediate the material weakness described above, 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 period ended March 31, 2024 that materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
25
PART II—OTHER INFORMATION
Item 1. Legal Proceedings.
From time to time, we may become involved in various claims and legal proceedings. We are not currently a party to any legal proceedings that, in the opinion of our management, are likely to have a material adverse effect on our business, financial condition or results of operations. Regardless of outcome, litigation can have an adverse impact on us because of defense and settlement costs, diversion of management resources and other factors.
Item 1A. Risk Factors.
No additional risk factors have arisen not already disclosed in our Annual Report on Form 10-K for the year-ended December 31, 2023, filed April 16, 2024.
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds.
During the three months ended March 31, 2024, we did not have sales of unregistered securities
Item 3. Defaults Upon Senior Securities.
N/A
Item 4. Mine Safety Disclosures.
N/A
Item 5. Other Information.
During the three months ended March 31, 2024, no director or officer of the Company
trading arrangement” or “non-Rule 10b5-1 trading arrangement,” as each term is defined in Item 408(a) of Regulation
S-K.Item 6. Exhibits.
26
Item 6. Exhibits
Exhibit Index
|
|
|
Exhibit |
|
Description |
|
|
|
3.1 |
|
|
4.1 |
|
|
4.2 |
|
|
4.3 |
|
|
10.4+# |
|
|
10.5 |
|
|
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
+ Indicates management contract or compensatory plan or arrangement.
# Certain of the exhibits and schedules to this Exhibit have been omitted in accordance with Regulation S-K Item 601(a)(5). The
Registrant agrees to furnish a copy of all omitted exhibits and schedules to the SEC upon its request; provided, however, that the
Registrant may request confidential treatment pursuant to Rule 24b-2 of the Exchange Act, as amended, for any schedule or
exhibit so furnished.
27
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the Registrant has duly caused this Report to be signed on its behalf by the undersigned, thereunto duly authorized.
|
|
SeaStar Medical Holding Corporation |
|
|
|
|
|
Date: May 14, 2024 |
|
By: |
/s/ Eric Schlorff |
|
|
|
Eric Schlorff |
|
|
|
Chief Executive Officer (Principal Executive Officer) |
|
|
|
|
Date: May 14, 2024 |
|
By: |
/s/ David Green |
|
|
|
David Green |
|
|
|
Chief Financial Officer (Principal Financial and Accounting Officer) |
28
EXHIBIT 31.1
Certification Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
I, Eric Schlorff, certify that:
1. I have reviewed this Quarterly Report on Form 10-Q of SeaStar Medical Holding Corporation;
2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
4. The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
a. designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
b. designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
c. evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
d. disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
5. The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of registrant’s board of directors (or persons performing the equivalent functions):
a) all significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
b) any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.
Date: May 14, 2024
|
|
|
/s/ Eric Schlorff |
||
Eric Schlorff |
||
Chief Executive Officer |
EXHIBIT 31.2
Certification Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
I, David Green, certify that:
1. I have reviewed this Quarterly Report on Form 10-Q of SeaStar Medical Holding Corporation;
2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
4. The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
a) designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
b) designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
c) evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
d) disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
5. The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of registrant’s board of directors (or persons performing the equivalent functions):
a) all significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
b) any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.
Date: May 14, 2024
|
|
|
/s/ David Green |
||
David |
||
Chief Financial Officer |
EXHIBIT 32.1
Certification Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
I, Eric Schlorff, Chief Executive Officer of SeaStar Medical Holding Corporation (the “Company”), certify that:
1. the Quarterly Report on Form 10-Q of the Company for the three months ended March 31, 2024 as filed with the Securities and Exchange Commission (the “Report”) fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and
2. the information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.
Date: May 14, 2024
|
|
|
/s/ Eric Schlorff |
||
Eric Schlorff |
||
Chief Executive Officer |
EXHIBIT 32.2
Certification Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
I, David Green, Chief Financial Officer of SeaStar Medical Holding Corporation (the “Company”), certify that:
1. the Quarterly Report on Form 10-Q of the Company for the three months ended March 31, 2024 as filed with the Securities and Exchange Commission (the “Report”) fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and
2. the information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.
Date: May 14, 2024
|
|
|
/s/ David Green |
||
David Green |
||
Chief Financial Officer |
Condensed Consolidated Balance Sheets (Parenthetical) - $ / shares |
Mar. 31, 2024 |
Dec. 31, 2023 |
---|---|---|
Preferred stock par value | $ 0.0001 | $ 0.0001 |
Preferred stock, shares authorized | 10,000,000 | 10,000,000 |
Preferred stock, shares issued | 0 | 0 |
Preferred stock, shares outstanding | 0 | 0 |
Common stock, par value | $ 0.0001 | $ 0.0001 |
Common stock, shares authorized | 500,000,000 | 500,000,000 |
Common stock, shares issued | 75,419,458 | 47,615,285 |
Common stock, shares outstanding | 75,419,458 | 47,615,285 |
Condensed Consolidated Statements of Operations (Unaudited) - USD ($) $ in Thousands |
3 Months Ended | |
---|---|---|
Mar. 31, 2024 |
Mar. 31, 2023 |
|
Operating expenses | ||
Research and development | $ 1,697 | $ 1,730 |
General and administrative | 2,253 | 2,851 |
Total operating expenses | 3,950 | 4,581 |
Loss from operations | (3,950) | (4,581) |
Other income (expense) | ||
Interest expense | (143) | (433) |
Change in fair value of convertible notes | (5,758) | 100 |
Change in fair value of warrants liability | (2,846) | 36 |
Change in the fair value of the forward purchase agreement derivative liability | 0 | (2,218) |
Total other income (expense), net | (8,747) | (2,515) |
Loss before provision for income taxes | (12,697) | (7,096) |
Provision for income taxes | 0 | 0 |
Net loss | $ (12,697) | $ (7,096) |
Net loss per share: | ||
Net loss per share of common stock, basic | $ (0.19) | $ (0.54) |
Net loss per share of common stock, diluted | $ (0.19) | $ (0.54) |
Weighted-average shares outstanding - basic | 67,106,081 | 13,025,852 |
Weighted-average shares outstanding - diluted | 67,106,081 | 13,025,852 |
Pay vs Performance Disclosure - USD ($) $ in Thousands |
3 Months Ended | |
---|---|---|
Mar. 31, 2024 |
Mar. 31, 2023 |
|
Pay vs Performance Disclosure | ||
Net Income (Loss) | $ (12,697) | $ (7,096) |
Insider Trading Arrangements |
3 Months Ended |
---|---|
Mar. 31, 2024 | |
Trading Arrangements, by Individual | |
Rule 10b5-1 Arrangement Adopted | false |
Non-Rule 10b5-1 Arrangement Adopted | false |
Rule 10b5-1 Arrangement Terminated | false |
Non-Rule 10b5-1 Arrangement Terminated | false |
Description of Business |
3 Months Ended |
---|---|
Mar. 31, 2024 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Description of Business | Note 1. Description of Business Organization and description of business
SeaStar Medical Holding Corporation, a Delaware corporation ("SeaStar", "we") and its wholly owned subsidiary, SeaStar Medical, Inc., are collectively referred to as the "Company". SeaStar Medical, Inc. was incorporated as a Delaware corporation in June 2007, and it is headquartered in Denver, Colorado. The Company is principally engaged in the research, development, and commercialization of a platform medical device technology designed to modulate inflammation in various patient populations. The primary target of this technology is for the treatment of acute kidney injuries.
The Company is in the pre-revenue stage focused on product development.
On October 28, 2022, LMF Merger Sub, Inc., a wholly owned subsidiary of LMF Acquisition Opportunities, Inc., (“LMAO”) merged with and into SeaStar Medical, Inc. (the "Business Combination"), with SeaStar Medical, Inc. surviving the Business Combination as a wholly owned subsidiary of LMAO. Following the consummation of the Business Combination, LMAO was renamed to "SeaStar Medical Holding Corporation."
Basis of presentation and consolidation
The accompanying unaudited condensed consolidated financial statements have been prepared in conformity with accounting principles generally accepted in the United States of America ("U.S. GAAP") and the rules and regulations of the Securities and Exchange Commission ("SEC") for interim reporting. As permitted under those rules and regulations, certain notes or other financial information normally included in financial statements prepared in accordance with U.S. GAAP have been condensed or omitted. The interim unaudited condensed consolidated financial statements have been prepared on the same basis as the annual consolidated financial statements and, in the opinion of management, reflect all adjustments, which include only normal, recurring adjustments that are necessary to present fairly the Company’s results for the interim periods presented. The results from operations for the three months ended March 31, 2024, are not necessarily indicative of the results to be expected for the year ended December 31, 2024, or for any future annual or interim period.
The accompanying interim unaudited condensed consolidated financial statements should be read in conjunction with the annual consolidated financial statements and the related notes for the year ended December 31, 2023. There have been no material changes in our significant accounting policies as described in our Annual Report on Form 10-K for the year ended December 31, 2023.
The interim unaudited condensed consolidated financial statements include the consolidated accounts of the Company's wholly owned subsidiary, SeaStar Medical, Inc. All significant intercompany transactions have been eliminated in consolidation.
Segment information
The Company operates in one operating segment and, accordingly, no segment disclosures have been presented herein.
Liquidity and going concern
As of March 31, 2024, the Company has an accumulated deficit of $127.4 million and cash of $5.0 million. We do not believe that will be sufficient to enable us to fund our operations, including clinical trial expenses and capital expenditure requirements for at least 12 months from the issuance of these unaudited interim condensed consolidated financial statements. We believe that these conditions raise substantial doubt about our ability to continue as a going concern.
Our need for additional capital will depend in part on the scope and costs of our development activities. To date, we have not generated any revenue from the sales of commercialized products. Our ability to generate product revenue will depend on the successful development and eventual commercialization of our product. Until such time, if ever, we expect to finance our operations through the sale of equity or debt, borrowing under credit facilities, or through potential collaborations, other strategic transactions or government and other grants. Adequate capital may not be available to us when needed or on acceptable terms.
Risks and uncertainties
The Company is subject to risks common to early-stage companies in the medical technology industry including, but not limited to, new medical and technological innovations, dependence on key personnel, protection of proprietary technology, and product liability. There can be no assurance that the Company's products or services will be accepted in the marketplace, nor can there be any assurance that any future products or services can be developed or deployed at an acceptable cost and with appropriate performance characteristics, or that such products or services will be successfully marketed, if at all. These factors could have a materially adverse effect on the Company's future financial results, financial position and cash flows. |
Summary of Significant Accounting Policies |
3 Months Ended |
---|---|
Mar. 31, 2024 | |
Summary of Significant Accounting Policies | Note 2. Summary of Significant Accounting Policies
Use of estimates
The preparation of the unaudited interim condensed consolidated financial statements in conformity with U.S. GAAP requires management to make estimates, assumptions and judgments that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the consolidated financial statements and reported amounts of revenues and expenses during the period. Significant estimates include the valuation of the liability classified warrants, prepaid forward purchase agreement derivative liability, provision for income taxes, convertible debt measured at fair value, and the amount of stock-based compensation expense. Although actual results could differ from those estimates, such estimates are developed based on the best information available to management and management's best judgments at the time.
Concentrations of credit risk
Financial instruments that potentially subject the Company to a significant concentration of credit risk consist primarily of cash. Periodically, the Company may maintain deposits in financial institutions in excess of government insured limits. Any loss incurred or a lack of access to such funds could have a significant adverse impact on the Company's financial condition, results of operations, and cash flows.
Fair value of financial instruments
The following provides a summary of those assets or liabilities for which the Company is required to measure at fair value either on a recurring basis, the valuation techniques and summary of inputs used to arrive at the measure of fair value. Changes in fair value of these assets or liabilities are recognized as a component of net income in the consolidated statement of operations. Changes in fair value of these assets or liabilities are considered unrealized gains or losses and therefore are classified as non-cash adjustments to reconcile net income to operating cash flows. Significant increases (decreases) in unobservable inputs used in fair value measurements could, in isolation, potentially result in a significantly lower or higher valuation for those assets or liabilities requiring recurring fair value measurements at each reporting date.
The Company uses a Black-Scholes option pricing model to fair value Warrants, using standard option pricing inputs such as the strike price of each warrant tranche, estimated volatility, time to maturity, and the risk-free interest rate. The risk-free interest rate is the U.S. Treasury rate at the date of issuance, and the time to maturity is based on the contractual life at the date of issuance, which is an interpolated value based on the remaining term of each individual instrument. The change in fair value of the liability classified warrants each reporting period is recorded to the change in fair value of warrants liability in the consolidated statement of operations.
Emerging growth company status
The Company is an “emerging growth company”, as defined in the Jumpstart Our Business Startups Act of 2012 ("JOBS Act"). Under the JOBS Act, emerging growth companies can take advantage of an extended transition period for complying with new or revised accounting standards, delaying the adoption of these accounting standards until they would apply to private companies. The Company has elected to use this extended transition period for complying with certain new or revised accounting standards that have different effective dates for public and private companies until the earlier of the date that it is (1) no longer an emerging growth company or (2) affirmatively and irrevocably opt out of the extended transition period provided in the JOBS Act.
Recently issued accounting standards
In December 2023, the Financial Accounting Standards Board (“FASB”) issued ASU 2023-09 Income Taxes (Topic 740) Improvements to Income Tax Disclosures. ASU 2023-09 enhances the transparency and decision usefulness of income tax disclosures. The amendments in this update are effective for public business entities for annual periods beginning after December 15, 2024. Early adoption is permitted. We are currently assessing the impact of this guidance on our disclosures. |
Accrued Expenses |
3 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Mar. 31, 2024 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Accrued Liabilities, Current [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Accrued Expenses | Note 3. Accrued Expenses Accrued expenses consisted of the following amounts as of March 31, 2024 and December 31, 2023:
|
Notes Payable |
3 Months Ended | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Mar. 31, 2024 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Notes Payable [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Notes Payable | Note 4. Notes Payable Notes payable activity was as follows for the three month period ended March 31, 2024:
Future maturities of principal repayment of the notes payable as of March 31, 2024 are as follows:
Senior Secured LMFA Note Payable
The company entered into a senior secured note with LMFA in September 2022. The interest rate on the loan was 7.0% and was to mature on March 27, 2025. The Company paid this note in full during Q1 2024.
Senior Secured LMFAO Note Payable
The company entered into a senior secured note with LMFAO in October 2022. The interest rate on the loan was 7.0% and was to mature on March 27, 2025. The Company paid this note in full during Q1 2024.
Unsecured Maxim Note Payable
In October 2022, the Company entered into an unsecured promissory note with Maxim, for an aggregate principal amount of $4.2 million. The interest rate on the note is 7% and matures on May 8, 2025.
Insurance Financing
In October 2023, the Company entered into a financing arrangement with a lender to finance a portion of the annual premium of an insurance policy in the amount of $0.7 million. The Company will pay the remaining five monthly installments of principal and interest with the last payment being made in August 2024. |
Convertible Notes |
3 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Mar. 31, 2024 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Debt Disclosure [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Convertible Notes | Note 5. Convertible Notes The activity for the convertible notes is disclosed in the table below for the period ended March 31, 2024. See our Annual Report on Form 10-K for the year-ended for December 31, 2023, for all other details relating to the Investor D convertible notes issued prior to December 31, 2023. During the quarter-ended March 31, 2024, the Company entered into two additional Investor D note issuances: The Company completed Additional Closings related to the Second Amendment to the Investor D SPA on January 12, 2024 and January 24, 2024, issuing notes in principal amounts of $0.3 million and $0.8 million, respectively, each at 7.00% per annum (the "Fifth Investor D Note" and "Sixth Investor D Note", collectively called the "2024 Investor D Notes"). The 2024 Investor D Notes mature on April 12, 2025 and April 24, 2025, respectively. The 2024 Investor D Notes have an initial conversion price of $0.56 per share and are convertible into shares of the Company's common stock, par value $0.0001 (the "common stock"), beginning on the earlier of June 11, 2024 (or earlier upon mutual written agreement of the Company and the purchaser), or the date of an event of default, as defined in the note. The Company also issued warrants to purchase up to 131,927 and 395,781 shares of common stock, respectively, with an exercise price of $0.56 per share, and an additional warrants to purchase up to 131,927 and 395,781 shares of common stock, respectively, with an exercise price of $0.56 per share.
Future maturities of principal repayment of convertible Notes as of March 31, 2024, was as follows:
On January 30, 2024, the institutional investor agreed to waive its Optional Redemption Rights and any event of default that may arise thereunder with respect to this offering and suspend the Optional Redemption Rights for a period of sixty (60) days following the closing of this offering (the “Suspension Period”), and the Company granted the institutional investor a right to redeem all or a portion of the then outstanding Conversion Amount (as defined in the Note Documents) within three (3) trading days after the Suspension Period at an amount equal to 200% of the Conversion Amount.
During the quarter-ended March 31, 2024, the institutional investor converted approximately $3.3 million (face value) of outstanding debt, by converting the outstanding debt into approximately $9.5 million of the Company's common stock. As of March 31, 2024, the Company still owed the institutional investor approximately $1.0 million (face value) in convertible debt, with a fair value of approximately $1.1 million.
The Company incurred a loss of approximately $5.8 million as a result of the following: (i) $4.7 million loss on conversion into equity as a result of the difference between the fair value of the convertible notes being converted and the equity being delivered, (ii) $0.7 million losses on issuance of the Investor D convertible notes issued during the three-months ended March 31, 2024, as a result of the combination of the fair value of detachable warrants issued in conjunction to the Investor D Notes issues during the three-months ended March 31, 2024, and the excess fair value over the proceeds received for the Investor D convertible notes issues during the three-months ended March 31, 2024, and (iii) $0.4 million loss on the change in fair value of those Investor D convertible notes still outstanding as of March 31, 2024. |
Equity Transactions |
3 Months Ended |
---|---|
Mar. 31, 2024 | |
Stockholders' Equity Note [Abstract] | |
Equity Transactions | Note 6. Equity Transactions On January 26, 2024, the Company entered into a Securities Purchase Agreement with a single institutional investor, pursuant to which the Company issued to the Purchaser (the "Q1 2024 SPA"), (i) in a registered direct offering, 6,304,545 shares of the Company’s common stock, par value $0.0001 per share, and pre-funded warrants to purchase 4,536,216 shares of Common Stock with an exercise price of $0.0001 per share, and (ii) in a concurrent private placement, series A warrants to purchase 10,840,761 shares of common stock (the "Series A Common Warrants") and series B warrants to purchase 5,420,381 shares of common stock each with an exercise price of $0.8302 (the "Series B Common Warrants" and together with the Series A Common Warrants, the "Investor E Warrants". Such registered direct offering and concurrent private placement are referred to herein as the “Transactions.” The Company received aggregate gross proceeds from the Transactions of approximately $9.0 million, before deducting fees to the Placement Agent and other estimated offering expenses payable by the Company. The Shares were declared effective on December 22, 2023. The Investor E Warrants will be exercisable commencing on the effective date of stockholder approval for the issuance of the shares of common stock issuable upon exercise of the Investor E Warrants. The Series A Common Warrants will expire on the fifth anniversary of the Stockholder Approval Date and the Series B Common Warrants will expire on the 12 month anniversary of the Stockholder Approval Date. The Pre-Funded Warrants will not expire and will be exercisable commencing on January 26, 2024, and at any time until all of the Pre-Funded Warrants are exercised in full. All Pre-Funded Warrants were exercised during the first quarter ended March 31, 2024. The Company paid approximately $0.7 million in fees to the Placement Agent and issued 542,038 warrants (the "PA Warrants") to purchase shares of the Company's common stock, with a fair value of approximately $0.3 million at issuance. The exercise price of these warrants is $0.9132 and the warrants became exercisable on January 30, 2024, expiring one year after the grant date. Tumin Equity Line of Credit During the year ended December 31, 2023, the Company sold 6,500,000 shares of common stock to Tumim for proceeds of approximately $4.7 million as part of the Tumin Equity Line of Credit (see the Company's Annual Report on Form 10-K for the year-ended December 31, 2023, for additional information on the structure and purpose). As of December 31, 2023, approximately $95.3 million was available to draw. In February 2024, the Company and Tumim agreed to terminate the Purchase Agreement. |
Warrants |
3 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Mar. 31, 2024 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Warrants and Rights Note Disclosure [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Warrants | Note 7. Warrants
Warrants Issued in FY 2024 As discussed in Note 7, as part of the Q1 2024 SPA, the Company issued on January 26, 2024 the following warrants to purchase the Company's common stock: • Pre-Funded Warrants - warrants to purchase 4,536,216 shares of common stock with an exercise price of $0.0001. The Pre-Funded Warrants had no expiration date and were exercisable commencing on the date of issuance and at any time until all of the Pre-Funded Warrants are exercised in full. The Pre-Funded Warrants were exercised in full during the first quarter-ended March 31, 2024 • Series A and Series B Warrants - in a concurrent private placement, Series A Common Warrants to purchase 10,840,761 shares of Common Stock and Series B Common Warrants to purchase 5,420,381 shares of common stock each with an exercise price of $0.8302. • Investor E Warrants will be exercisable commencing on the effective date of stockholder approval for the issuance of the shares of common stock issuable upon exercise of the Investor E Warrants. The Series A Common Warrants will expire on the fifth anniversary of the Stockholder Approval Date and the Series B Common Warrants will expire on the 12-month anniversary of the Stockholder Approval Date.
Maxim Group LLC acted as the placement agent in connection with the Transactions pursuant to the Placement Agency Agreement, dated January 26, 2024, by and between the Company and the Placement Agent. The Placement Agent will receive warrants to purchase common stock covering a number of shares equal to 5% of the total number of shares of common stock sold in the Transactions. The PA Warrants will be exercisable commencing six months after the Closing and will expire five years after such date. The PA Warrants are exercisable at a price equal to 110.0% of the offering price in connection with the placement. In accordance with ASC 815-40, Derivatives and Hedging-Contracts in Entity’s own Equity, the Company determined the Investor E and PA Warrants meet the conditions for equity classification, and should be carried on the consolidated balance sheets as a component of stockholders equity (deficit). The initial fair value of the convertible note warrants was determined using a Black-Scholes option pricing model, which considers variables such as estimated volatility, time to maturity, and the risk-free interest rate. The risk-free interest rate is the U.S. Treasury rate at the date of issuance, and the time to maturity is based on the contractual life at the date of issuance, which is five years. The Company had the following warrants outstanding at March 31, 2024 and December 31, 2023:
The following tables provides the weighted-average strike price and time to maturity for each warrant tranche as of March 31, 2024 and December 31, 2023:
Below is the warrant activity for the period ended March, 31, 2024:
During the quarter-ended March 31, 2024, the Company incurred $1.6 million from losses on exercises of certain Investor D Warrants, and a loss of approximately $1.2 million from the mark-to-market adjustment for all remaining liability classified warrants; which are required to be remeasured at fair value at each reporting period, including March 31, 2024. ` |
Stock-Based Compensation Awards |
3 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Mar. 31, 2024 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Share-Based Payment Arrangement [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Stock-Based Compensation Awards | Note 8. Stock-Based Compensation Awards The following table sets forth the total stock-based compensation cost included in the Company's condensed consolidated statements of operations for the period indicated: Hi, I am hiring for my 9* logistics company. If interested, please send working stats and # of EE merits. Thank you!
Equity incentive plan - summary 2022 Omnibus Incentive Plan The Company's Board of Directors adopted, and the shareholders approved the 2022 Omnibus Incentive Plan to provide long-term incentive for its employees and non-employee service providers. The vesting of stock options is stated in each individual grant agreement, which is generally either or four years. Options granted expire 10 years after the date of grant. 2019 Stock Incentive Plan The Company’s Board of Directors adopted the 2019 Stock Incentive Plan on February 25, 2019, to provide long-term incentive for its employees and non-employee service providers. The Stock Incentive Plan was terminated on October 28, 2022, and no further awards were granted under such plan. Equity incentive plan - stock options Option activity for the periods ended March 31, 2024, is as follows: 2022 Omnibus Incentive Plan - Options
2019 Omnibus Incentive Plan - Options
Equity incentive plan - restricted stock units A summary of the Company’s restricted stock unit (‘RSU”) activity is as follows: 2022 Omnibus Incentive Plan - RSUs
2019 Stock Incentive Plan - RSUs
|
Commitments and Contingencies |
3 Months Ended |
---|---|
Mar. 31, 2024 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | Note 9. Commitments and Contingencies License and distribution agreement On December 27, 2022, the Company entered into a license and distribution agreement (“License Agreement”) with a distributor, appointing the distributor as the exclusive distributor to promote, advertise, market, distribute and sell the Selective Cytopheretic Device (“SCD”) in the United States. The Company received an upfront payment of $0.1 million on January 3, 2023. Pursuant to the License Agreement, the Company received milestone payments in the amounts of approximately $0.5 million for obtaining a Humanitarian Device Approval ("HDE") from the Food and Drug Administration (the "FDA") and shall receive another milestone payment of approximately $0.4 million after the distributor sells the first sixty units to third parties. The term of the agreement is three years. The license agreement was amended in December 2023, removing the potential to require refund of the $0.1 million up-front payment from the Company to the distributor, while extending a certain milestone payment owed to the Company upon certain regulatory achievements. However, recognition for such relief from repayment of the deposit would be recognized over the remaining term of the agreement due to certain ongoing future obligations of the Company under the arrangement. Lease agreements The Company is part of a membership agreement for shared office space and can cancel at any time. Rent expense was approximately $8 thousand for the three months ended March 31, 2024 and 2023, respectively. Litigation Liabilities for loss contingencies arising from claims, assessments, litigation, fines, penalties, and other sources are recorded when it is probable that a liability has been incurred and the amount can be reasonably estimated. From time to time, the Company may become involved in legal proceedings arising in the ordinary course of business. In connection with the Business Combination, LMAO proposed, for stockholder approval, various amendments to its Amended and Restated Certificate of Incorporation, which included among other things a proposal to increase the authorized shares of common stock. A purported stockholder sent a Stockholder Litigation Demand letter (the “Demand”) to the Board of Directors of LMAO alleging that the Delaware General Corporation Law required a separate class vote of the Class A common stockholders to increase the authorized shares of common stock. Following receipt of the Demand, the Company canceled and withdrew the proposal to increase the authorized shares of common stock. The stockholder’s counsel thereafter demanded that the Company pay counsel fees for the purported benefit conferred upon the Company’s shareholders by causing the Company to withdraw the allegedly invalid proposal to increase the authorized shares of common stock. The Company paid approximately $0.2 million for a legal settlement during the year ended December 31, 2023. |
Fair Value Measurements |
3 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Mar. 31, 2024 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Fair Value Disclosures [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Fair Value Measurements | Note 10. Fair Value Measurements Fair value is defined as the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date (exit price). Inputs used to measure fair value are classified into the following hierarchy: Level 1 – quoted prices in active markets for identical assets and liabilities. Level 2 – other significant observable inputs (including quoted prices for similar assets and liabilities, interest rate, credit risk, etc.). Level 3 – significant unobservable inputs (including the Company’s own assumptions in determining the fair value of assets and liabilities). The fair value of the forward option on prepaid forward contracts, convertible notes, and the warrants liability is classified as Level 3 in the fair value hierarchy.
Fair Value Measurement Hierarchy The following table presents the Company's financial assets and/or liabilities that were accounted for at fair value on a recurring basis as of March 31, 2024 and December 31, 2023, by level withing the fair value hierarchy. There were no non-recurring fair value measurements, as the Company does not have any long-lived assets, including fixed assets, intangible assets or goodwill which can require non-recurring measurements for impairment.
Summary of Level 3 Input Changes The following table presents the changes in the forward option-prepaid forward contracts, convertible notes measured at fair value, warrants liability, and the notes derivative liability for the periods ended March 31, 2024 and December 31, 2023 (in thousands):
Level 3 Inputs
For assets or liabilities for which the Company is required to remeasure the fair value on a recurring basis at each reporting date, generally the Company is required to disclose certain quantitative data related to the inputs used at the most recent reporting period date. However, for those assets or liabilities for which the Company has elected to take the FVO in accordance with ASC 825, Financial Instruments, then such quantitative disclosures are not required.
Liability Classified Warrants
The liability classified warrants as of March 31, 2024 and December 31, 2023, include three classes of warrants, and therefore, the range of assumptions used has been provided. Significant assumptions used in valuing warrants which require liability classification were as follows as of March 31, 2024 and December 31, 2023.
|
Income Taxes |
3 Months Ended |
---|---|
Mar. 31, 2024 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | Note 11. Income Taxes In accordance with U.S. GAAP, a valuation allowance should be provided if it is more likely than not that some or all of the Company’s deferred tax assets will not be realized. The Company’s ability to realize the benefit of its deferred tax assets will depend on the generation of future taxable income. Due to the uncertainty of future profitable operations and taxable income, the Company has recorded a full valuation allowance against its net deferred tax assets. The Company believes its tax filing position and deductions related to tax periods subject to examination will be sustained under audit and, therefore, has no reserve for uncertain tax positions. |
Net Loss Per Share |
3 Months Ended | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Mar. 31, 2024 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Earnings Per Share [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Net Loss Per Share | Note 12. Net Loss Per Share
The following table presents the calculation of basic and diluted net loss per share (in thousands except share and per share information):
The following weighted-average outstanding shares of potentially dilutive securities were excluded from the computation of diluted net loss per share attributable to common stockholders for the periods presented because including them would have been anti-dilutive:
|
Subsequent Events |
3 Months Ended |
---|---|
Mar. 31, 2024 | |
Subsequent Events [Abstract] | |
Subsequent Events | Note 13. Subsequent Events Investor D April 2024 Side Letter On April 1, 2024, the Company and Investor D entered into the a side letter agreement (the "April 2024 Side Letter") whereby each party agreed to suspend certain rights of Investor D for a 60 day period, extending those rights from March 30, 2024, to May 30, 2024. Those rights included a 10 day notice period for any subsequent financing and rights to review terms of such financing arrangements. Finally, Investor D waived its rights or notice of default in the event of such financings. In addition, after the end to the May 30, 2024, suspension period has been reached, Investor D has the right to require the Company to redeem all or a portion of any outstanding Investor D convertible notes in the amount equity to 200% of the conversion amount. |
Summary of Significant Accounting Policies (Policies) |
3 Months Ended |
---|---|
Mar. 31, 2024 | |
Use of Estimates | Use of estimates
The preparation of the unaudited interim condensed consolidated financial statements in conformity with U.S. GAAP requires management to make estimates, assumptions and judgments that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the consolidated financial statements and reported amounts of revenues and expenses during the period. Significant estimates include the valuation of the liability classified warrants, prepaid forward purchase agreement derivative liability, provision for income taxes, convertible debt measured at fair value, and the amount of stock-based compensation expense. Although actual results could differ from those estimates, such estimates are developed based on the best information available to management and management's best judgments at the time. |
Concentrations of credit risk | Concentrations of credit risk
Financial instruments that potentially subject the Company to a significant concentration of credit risk consist primarily of cash. Periodically, the Company may maintain deposits in financial institutions in excess of government insured limits. Any loss incurred or a lack of access to such funds could have a significant adverse impact on the Company's financial condition, results of operations, and cash flows. |
Fair value of financial instruments | Fair value of financial instruments
The following provides a summary of those assets or liabilities for which the Company is required to measure at fair value either on a recurring basis, the valuation techniques and summary of inputs used to arrive at the measure of fair value. Changes in fair value of these assets or liabilities are recognized as a component of net income in the consolidated statement of operations. Changes in fair value of these assets or liabilities are considered unrealized gains or losses and therefore are classified as non-cash adjustments to reconcile net income to operating cash flows. Significant increases (decreases) in unobservable inputs used in fair value measurements could, in isolation, potentially result in a significantly lower or higher valuation for those assets or liabilities requiring recurring fair value measurements at each reporting date.
The Company uses a Black-Scholes option pricing model to fair value Warrants, using standard option pricing inputs such as the strike price of each warrant tranche, estimated volatility, time to maturity, and the risk-free interest rate. The risk-free interest rate is the U.S. Treasury rate at the date of issuance, and the time to maturity is based on the contractual life at the date of issuance, which is an interpolated value based on the remaining term of each individual instrument. The change in fair value of the liability classified warrants each reporting period is recorded to the change in fair value of warrants liability in the consolidated statement of operations. |
Emerging growth company status | Emerging growth company status
The Company is an “emerging growth company”, as defined in the Jumpstart Our Business Startups Act of 2012 ("JOBS Act"). Under the JOBS Act, emerging growth companies can take advantage of an extended transition period for complying with new or revised accounting standards, delaying the adoption of these accounting standards until they would apply to private companies. The Company has elected to use this extended transition period for complying with certain new or revised accounting standards that have different effective dates for public and private companies until the earlier of the date that it is (1) no longer an emerging growth company or (2) affirmatively and irrevocably opt out of the extended transition period provided in the JOBS Act. |
Recently issued accounting standards | Recently issued accounting standards
In December 2023, the Financial Accounting Standards Board (“FASB”) issued ASU 2023-09 Income Taxes (Topic 740) Improvements to Income Tax Disclosures. ASU 2023-09 enhances the transparency and decision usefulness of income tax disclosures. The amendments in this update are effective for public business entities for annual periods beginning after December 15, 2024. Early adoption is permitted. We are currently assessing the impact of this guidance on our disclosures. |
Accrued Expenses (Tables) |
3 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Mar. 31, 2024 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Accrued Liabilities, Current [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Summary of Accrued Expenses | Accrued expenses consisted of the following amounts as of March 31, 2024 and December 31, 2023:
|
Notes Payable (Tables) |
3 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Mar. 31, 2024 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Notes Payable [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Summary of Notes Payable | Notes payable activity was as follows for the three month period ended March 31, 2024:
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of Future Maturities of Principal Repayment of Convertible Notes | Future maturities of principal repayment of the notes payable as of March 31, 2024 are as follows:
|
Convertible Notes (Tables) |
3 Months Ended | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Mar. 31, 2024 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Debt Instrument [Line Items] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
The Activity for the Convertible Notes | The activity for the convertible notes is disclosed in the table below for the period ended March 31, 2024.
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Convertible Notes [Member] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Debt Instrument [Line Items] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Future Maturities of Principal Repayment of Convertible Notes | Future maturities of principal repayment of convertible Notes as of March 31, 2024, was as follows:
|
Warrants (Tables) |
3 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Mar. 31, 2024 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Warrants and Rights Note Disclosure [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of Warrants Outstanding | The Company had the following warrants outstanding at March 31, 2024 and December 31, 2023:
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of Weighted-Average Strike Price and Time to Maturity for Each Warrant Tranche | The following tables provides the weighted-average strike price and time to maturity for each warrant tranche as of March 31, 2024 and December 31, 2023:
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of Warrant Activity | Below is the warrant activity for the period ended March, 31, 2024:
|
Stock-Based Compensation Awards (Tables) |
3 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Mar. 31, 2024 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of Stock-based Compensation Expense | The following table sets forth the total stock-based compensation cost included in the Company's condensed consolidated statements of operations for the period indicated: Hi, I am hiring for my 9* logistics company. If interested, please send working stats and # of EE merits. Thank you!
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
2022 Omnibus Incentive Plan [Member] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Summary of Option activity | 2022 Omnibus Incentive Plan - Options
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Summary of RSU Activity | A summary of the Company’s restricted stock unit (‘RSU”) activity is as follows: 2022 Omnibus Incentive Plan - RSUs
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
2019 Stock Incentive Plan [Member] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Summary of Option activity | 2019 Omnibus Incentive Plan - Options
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Summary of RSU Activity | 2019 Stock Incentive Plan - RSUs
|
Fair Value Measurement (Tables) |
3 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Mar. 31, 2024 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Fair Value Disclosures [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of Financial Assets and Liabilities Measured at Fair Value on Recurring Basis | The following table presents the Company's financial assets and/or liabilities that were accounted for at fair value on a recurring basis as of March 31, 2024 and December 31, 2023, by level withing the fair value hierarchy. There were no non-recurring fair value measurements, as the Company does not have any long-lived assets, including fixed assets, intangible assets or goodwill which can require non-recurring measurements for impairment.
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Summary of Changes in Forward Option and Convertible Notes Derivative Liability | The following table presents the changes in the forward option-prepaid forward contracts, convertible notes measured at fair value, warrants liability, and the notes derivative liability for the periods ended March 31, 2024 and December 31, 2023 (in thousands):
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of Significant Assumptions Valuing of Fair Value | The liability classified warrants as of March 31, 2024 and December 31, 2023, include three classes of warrants, and therefore, the range of assumptions used has been provided. Significant assumptions used in valuing warrants which require liability classification were as follows as of March 31, 2024 and December 31, 2023.
|
Net Loss Per Share (Tables) |
3 Months Ended | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Mar. 31, 2024 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Earnings Per Share [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Summary of Weighted-Average Outstanding Shares | The following weighted-average outstanding shares of potentially dilutive securities were excluded from the computation of diluted net loss per share attributable to common stockholders for the periods presented because including them would have been anti-dilutive:
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Summary of Weighted Average Shares Outstanding for Basic and Diluted Net Loss Per Share | The following table presents the calculation of basic and diluted net loss per share (in thousands except share and per share information):
|
Description of Business - Additional Information (Details) - USD ($) $ in Thousands |
Mar. 31, 2024 |
Dec. 31, 2023 |
---|---|---|
Organization, Consolidation and Presentation of Financial Statements [Abstract] | ||
Accumulated deficit | $ 127,431 | $ 114,734 |
Cash | $ 5,019 | $ 176 |
Accrued Expenses - Summary of Accrued Expenses (Details) - USD ($) $ in Thousands |
Mar. 31, 2024 |
Dec. 31, 2023 |
---|---|---|
Accrued Liabilities, Current [Abstract] | ||
Accrued bonus | $ 671 | $ 501 |
Accrued director compensation | 519 | 427 |
Accrued research and development | 308 | 507 |
Accrued legal | 0 | 43 |
Accrued interest | 29 | 19 |
Other | 17 | 26 |
Total accrued expenses | $ 1,544 | $ 1,523 |
Notes Payable - Summary of Notes payable (Details) - USD ($) $ in Thousands |
3 Months Ended | ||
---|---|---|---|
Mar. 31, 2024 |
Mar. 31, 2023 |
Dec. 31, 2023 |
|
Notes Payable [Line Items] | |||
Payments | $ (1,813) | $ (2,596) | |
Unamortized deferred financing costs, Balance | (52) | ||
Amortization of costs | 27 | $ 4 | |
Unamortized deferred financing costs, Balance | (25) | ||
Total | 1,135 | $ 4,373 | |
LMFA [Member] | |||
Notes Payable [Line Items] | |||
Notes payable, Balance | 296 | ||
Payments | (296) | ||
LMFAO [Member] | |||
Notes Payable [Line Items] | |||
Notes payable, Balance | 1,128 | ||
Payments | (1,128) | ||
Maxim [Member] | |||
Notes Payable [Line Items] | |||
Notes payable, Balance | 2,771 | ||
Payments | (181) | ||
Notes payable, Balance | 2,590 | ||
Insurance Financing [Member] | |||
Notes Payable [Line Items] | |||
Notes payable, Balance | 565 | ||
Payments | (208) | ||
Notes payable, Balance | $ 357 |
Notes Payable - Future Maturities of Principal Repayment of Convertible Notes (Details) $ in Thousands |
Mar. 31, 2024
USD ($)
|
---|---|
Notes Payable [Abstract] | |
2024 (remaining) | $ 357 |
2025 | 2,590 |
Total | $ 2,947 |
Notes Payable - Senior Secured LMFA Notes Payable - Additional Information (Details) - USD ($) $ in Thousands |
3 Months Ended | |
---|---|---|
Mar. 31, 2024 |
Mar. 31, 2023 |
|
Notes Payable [Line Items] | ||
Cash proceeds | $ 0 | $ 100 |
Senior Secured LMFA Notes Payable [Member] | ||
Notes Payable [Line Items] | ||
Debt instrument, interest rate | 7.00% | |
Debt instrument, maturity date | Mar. 27, 2025 |
Notes Payable - Senior Secured LMFAO Note Payable - Additional Information (Details) - Senior Secured LMFAO Note Payable [Member] |
3 Months Ended |
---|---|
Mar. 31, 2024 | |
Notes Payable [Line Items] | |
Debt instrument, maturity date | Mar. 27, 2025 |
Debt instrument, interest rate | 7.00% |
Notes Payable - Unsecured Maxim Note Payable - Additional Information (Details) - Unsecured Maxim Note Payable [Member] $ in Millions |
1 Months Ended |
---|---|
Oct. 31, 2022
USD ($)
| |
Notes Payable LineItems | |
Professional fees | $ 4.2 |
Debt instrument, interest rate | 7.00% |
Debt instrument, maturity date | May 08, 2025 |
Notes Payable - Insurance Financing - Additional Information (Details) - USD ($) $ in Thousands |
1 Months Ended | 3 Months Ended | |
---|---|---|---|
Oct. 31, 2023 |
Mar. 31, 2024 |
Dec. 31, 2023 |
|
Notes Payable [Line Items] | |||
Annual premium of insurance policy amount | $ 700 | ||
Frequency of principal and interest payments | monthly | ||
Payment terms | The Company will pay the remaining five monthly installments of principal and interest with the last payment being made in August 2024 | ||
Insurance Financing [Member] | |||
Notes Payable [Line Items] | |||
Notes payable, gross | $ 357 | $ 565 |
Convertible Notes - Future Maturities of Principal Repayment of Convertible Notes (Details) - USD ($) $ in Thousands |
Mar. 31, 2024 |
Dec. 31, 2023 |
---|---|---|
Debt Instrument [Line Items] | ||
Total | $ 1,135 | $ 4,373 |
Convertible Notes [Member] | ||
Debt Instrument [Line Items] | ||
2024 (remaining) | 0 | |
2025 | 1,135 | |
Total | $ 1,135 |
Stock-Based Compensation Awards - Schedule of Stock-based Compensation Expense (Details) - USD ($) $ in Thousands |
3 Months Ended | |
---|---|---|
Mar. 31, 2024 |
Mar. 31, 2023 |
|
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||
Stock-based compensation expense | $ 434 | $ 505 |
Research and Development [Member] | ||
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||
Stock-based compensation expense | 119 | 39 |
General and Administrative [Member] | ||
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||
Stock-based compensation expense | $ 315 | $ 466 |
Stock-Based Compensation Awards - Additional Information (Details) - Key Employees and Non-Employee Service Providers [Member] - 2022 Omnibus Incentive Plan [Member] |
3 Months Ended |
---|---|
Mar. 31, 2024 | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |
Options expiration period | 10 years |
Minimum [Member] | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |
Vesting period | 1 year |
Maximum [Member] | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |
Vesting period | 4 years |
Stock-Based Compensation Awards - Summary of RSU Activity (Details) - Restricted Stock Units (RSUs) [Member] |
3 Months Ended |
---|---|
Mar. 31, 2024
$ / shares
shares
| |
2022 Omnibus Incentive Plan [Member] | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |
Beginning Balance, Outstanding | 234,019 |
Granted | 0 |
Vested | 0 |
Forfeited / cancelled | 0 |
Ending Balance, Outstanding | 234,019 |
Beginning Balance, Outstanding | $ / shares | $ 1.47 |
Ending Balance, Outstanding | $ / shares | $ 1.47 |
2019 Stock Incentive Plan [Member] | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |
Beginning Balance, Outstanding | 92,442 |
Exercised | 0 |
Vested | (19,689) |
Forfeited / cancelled | 0 |
Ending Balance, Outstanding | 72,753 |
Beginning Balance, Outstanding | $ / shares | $ 8 |
Ending Balance, Outstanding | $ / shares | $ 8 |
Commitments and Contingencies - Additional Information (Details) - USD ($) $ in Thousands |
1 Months Ended | 3 Months Ended | |||
---|---|---|---|---|---|
Jan. 03, 2023 |
Dec. 27, 2022 |
Dec. 31, 2023 |
Mar. 31, 2024 |
Mar. 31, 2023 |
|
Loss Contingencies [Line Items] | |||||
Legal settlement in accrued expenses | $ 200 | ||||
Rent expense | $ 8 | $ 8 | |||
Upfront payment liability | 100 | $ 100 | |||
License and Distribution Agreement [Member] | |||||
Loss Contingencies [Line Items] | |||||
Proceeds from upfront payment | $ 100 | ||||
Proceeds from milestone payment | $ 400 | ||||
Agreement term | 3 years | ||||
Amended License and Distribution Agreement [Member] | |||||
Loss Contingencies [Line Items] | |||||
Nonrefundable upfront payment | $ 100 | ||||
Humanitarian Device Approval ("HDE") from FDA [Member] | License and Distribution Agreement [Member] | |||||
Loss Contingencies [Line Items] | |||||
Proceeds from milestone payment | $ 500 |
Fair Value Measurement - Summary of Changes in Forward Option and Convertible Notes Derivative Liability (Detail) - Level 3 [Member] $ in Thousands |
3 Months Ended |
---|---|
Mar. 31, 2024
USD ($)
| |
Convertible Notes [Member] | |
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items] | |
Balance | $ 4,373 |
Additions | 501 |
Cash paid to settle | 0 |
Shares issued upon conversion or exercise | (4,100) |
Changes in fair value | 361 |
Balance | 1,135 |
Liability Classified Warrants [Member] | |
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items] | |
Balance | 2,307 |
Additions | 586 |
Cash paid to settle | 0 |
Shares issued upon conversion or exercise | (3,106) |
Changes in fair value | 2,846 |
Balance | $ 2,633 |
Net Loss Per Share - Schedule of Earnings Per Share Basic And Diluted (Details) - USD ($) $ / shares in Units, $ in Thousands |
3 Months Ended | |
---|---|---|
Mar. 31, 2024 |
Mar. 31, 2023 |
|
Earnings Per Share [Abstract] | ||
Net loss | $ (12,697) | $ (7,096) |
Weighted-average shares outstanding - basic | 67,106,081 | 13,025,852 |
Basic net loss per share | $ (0.19) | $ (0.54) |
Weighted-average shares outstanding - diluted | 67,106,081 | 13,025,852 |
Diluted net loss per share | $ (0.19) | $ (0.54) |
Subsequent Events - Additional Information (Details) - Subsequent Event [Member] |
Apr. 01, 2024 |
---|---|
Subsequent Event [Line Items] | |
Percentage of conversion amount | 200.00% |
Suspention period | 60 days |
Investment right notice period | 10 days |
2(//:[IEN,K8
MU8R+^4JOL[2=V\U^;NC$W#Y3C@N-V<)LMJ!E2=N9@G\_DO*!U/]I8)9FF ^9
M"$C4,B[ ' ^ Y3:>+DL=?T7/>ULDP'*M]K(] )-O./"CA:EM@M^&M>X@$?0/^JM-#-_H!!: 5=4
M<"0A3[S59+E>V'@7\)-"JT[&R%:R%^+93C8D\0(K! PR;0G8/ YP#XQ9D-'X
MW3.]84N;>#H^TK^ZVDTM>ZS@7K!?E.@R\3YXB$".&Z9WHOT&?3TSR\L$4^X7
MM5UL]-%#6:.TJ/ID8U!1WCWQ2W\.)PF& \$^_';
MV=7,X:60[0S;TQJB0=(Q)N>WM>!M?=Z/21\]=D2E<1"O1TG<96+W<8&I*'93
MH!?W)/)>A=#GC4\+A">DD2N6' 1&6S&6JV.B5-/:VRXPO])^XV8I]1-IX6X;
M28?@ ]BUEB:&R>Y:8RC/:3&81%%(<_90X9/G67/A&D;7?/?XB4$WR%=-(E0IL 5;:X<:#4;'2^
M9G5 Z@[W,P00[!00-$L@TQ]6=+4BM=@A+T$E.GTQ(!>#B?CELS,E;%,'+: J
MA +7\7Q/V19MNDULH?4?(W3:"IFUU6OSHGV\H J9R(7#BFY'&1\OZ(
' T:CS 6-O7>$>S:'4#HE1^-*KH'"[29W%(0OR]($NQ-VP"HC
M[D['SFA\A(]#''OOL^,OM.^VFTU9O]U@)2J$SDNIMZJ9>5_6?U"G$??D
DUUS8I@QN>LLQBV9,'Q[U[[6_$=OBQUH->N
M_LU4<7-:O"A412O=U?V_Y"V9]GK*]T=9"_:IO7'A2J[$)T31:&!8VQZ;_^
MDN/P+0+S+# 7N]-&8N6%COKLQ+NM\KP:VOB'N"K2,,Y83LIU]/AJ(!?/+BB4
MWK02(;=2YUW @A!.9A'*>^U>8QY6,I]M7%E;+@WINC0F\M-,
M!V)!:6?9TNH?G*^6\&7/P_:P\61O:LG32:++?+;#V]NIX'^VCPI^2=
M.UI3B*0RYB%L/C3+;!($L>+:!P:!ORW?L%*!"#+^W7-F!Y+Q^9O\UQHY8
M*N'XQJBOLO'=,KO,J.%6C,I_,KO?>1_/F\!7&^7B+^V2[6R643TZ;_H]& IZ
MJ=._>-SGX0AP.?D!H-P#RJ@[.8HJ;X47JX4U.[+!&FQA$4.-:(B3.A3EWEM\
ME<#YU0==FY[ILWADMR@\&,-Y4>_1UPE=_@ ]HX]&^\[1+[KAYEM\ 24'.>6S
MG.OR+.%'87.:32^HG)3S,WRS0WBSR#?[:7AT*UVMC!LMTU_KRGF+"_'WJ9 3
MX_PT8VB2*S>(FI<9NL"QW7*V>OUJ^G;R_HS>^4'O_!S[3\MQ'OV'\4S3:4['
M--C@[M?&-D+7C.OE._J2W^?TVWI]=T&"MD*-(K6(0H]&*]>94354,0W6;"6*
M2[(EZ4DZZ@U2J.0#JR?RG="DC0\+3RXX-3;PD&EQQG1C^D'HI]>O+LOIN_
T
M4F,47[5=LHVTR I!>.7DCZ44!5,:52O'BB@N,8F[FD#"%
2B"<*R/W2W= '^ +?(;7N&D6G#'WV3V;%)T(N"%N"(R%.5K*"7
MX%CQ,43UOHSI#J<6P3]M=Z-[$>\Q^>;P-_BBI
M+-$958:M\^D%SDLNWK#&AV KOM5<.VS:-AG81#&!_1%+>/(Z8O^
MG?&U,*E41-JPORYGQFH,DK_W<:Y5QOM54N*