FibroBiologics, Inc 10-Q for FY2025 Q3
FibroBiologics, Inc. (FBLG)
About this 10-Q
FibroBiologics, Inc filed this 10-Q on October 31, 2025, covering the quarter ended September 30, 2025 (FY2025 Q3).
Headline figures
Quarter ended September 30, 2025, as reported in this filing, compared with the same period a year earlier where the filing states it.
- Net loss
- $5.78M
- compared with a net loss of $500K a year earlier
- Diluted EPS
- -$0.13
- compared with -$0.01 a year earlier
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
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QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) |
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or |
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TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) |
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Commission File Number:
(Exact name of registrant as specified in its charter)
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(State or other jurisdiction of |
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(I.R.S. Employer |
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N/A
(Former name, former address and former fiscal year, if changed since last report)
Securities registered pursuant to Section 12(b) of the Act:
Title of each class: |
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Name of each exchange on which registered: |
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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.
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, a 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 ☐ |
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Smaller reporting company |
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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
On October 31, 2025,
FibroBiologics, Inc.
Quarterly Report on Form 10-Q
For the Quarter Ended September 30, 2025
Table of Contents
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Item 1. |
4 |
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Condensed Consolidated Balance Sheets as of September 30, 2025 (Unaudited) and December 31, 2024 |
4 |
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5 |
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6 |
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7 |
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Notes to the Unaudited Condensed Consolidated Financial Statements |
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Item 2. |
Management’s Discussion and Analysis of Financial Condition and Results of Operations |
18 |
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Item 3. |
26 |
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Item 4. |
26 |
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Item 1. |
28 |
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Item 1A. |
28 |
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Item 2. |
31 |
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Item 3. |
32 |
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Item 4. |
32 |
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Item 5. |
32 |
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Item 6. |
33 |
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34 |
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1
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS
This quarterly report on Form 10-Q, or Quarterly Report, and the documents incorporated by reference herein, if any, contain forward-looking statements. We intend such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act of 1933, as amended, or the Securities Act, and Section 21E of the Securities Exchange Act of 1934, as amended, or the Exchange Act. All statements other than statements of historical facts contained in this Quarterly Report, including statements regarding our future results of operations and financial position, business strategy, prospective products, product approvals, research and development costs, future revenue, timing and likelihood of success, plans and objectives of management for future operations, future results of anticipated products and prospects, planned research programs, preclinical studies and clinical trials, and market opportunities are forward-looking statements. These statements involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance, or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements.
In some cases, you can identify forward-looking statements by terms such as “anticipate,” “believe,” “contemplate,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” or “would” or the negative of these terms or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements contained in this Quarterly Report include, but are not limited to, statements about:
We have based these forward-looking statements largely on our current expectations and projections about our business, the industry in which we operate and financial trends that we believe may affect our business, financial condition, results of operations and prospects, and these forward-looking statements are not guarantees of future performance or development. These forward-looking statements speak only as of the date of this Quarterly Report and are subject to a number of risks, uncertainties and assumptions described in the section titled “Risk Factors” and elsewhere in this Quarterly Report and in our Annual Report on Form 10-K for the year ended December 31, 2024, or the Annual Report. Because forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified, you should not rely on these forward-looking statements as predictions of future events. The events and circumstances reflected in our forward-looking statements may not be achieved or occur and actual results could differ materially from those projected in the forward-looking statements. You should read this Quarterly Report, the documents that we reference in this Quarterly Report and the other documents that we file with the Securities and Exchange Commission, or the SEC, with the understanding that our actual future results may be materially different from any future results expressed or implied by these forward-looking statements. Except as required by applicable law, we do not plan to publicly update or revise any forward-looking statements contained herein until after we distribute this Quarterly Report, whether as a result of any new information, future events or otherwise.
2
In addition, statements that “we believe” and similar statements reflect our beliefs and opinions on the relevant subject. These statements are based upon information available to us as of the date of this Quarterly Report, and while we believe such information forms a reasonable basis for such statements, such information may be limited or incomplete, and our statements should not be read to indicate that we have conducted an exhaustive inquiry into, or review of, all potentially available relevant information. These statements are inherently uncertain and you are cautioned not to unduly rely upon these statements.
3
PART I — FINANCIAL INFORMATION
Item 1. Financial Statements (Unaudited)
FibroBiologics, Inc.
Condensed Consolidated Balance Sheets
(in thousands, except shares and per share data)
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September 30, |
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December 31, |
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2025 |
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2024 |
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(unaudited) |
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Assets |
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Current assets |
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Cash and cash equivalents |
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$ |
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$ |
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Prepaid expenses |
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Other current assets |
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— |
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Total current assets |
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Property and equipment, net |
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Operating lease right-of-use asset, net |
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Other assets |
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— |
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Total assets |
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$ |
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$ |
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Liabilities and stockholders’ equity |
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Current liabilities |
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Accounts payable and accrued expenses |
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$ |
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$ |
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Operating lease liability, short-term |
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SEPA put option liability |
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Short-term convertible debt |
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Total current liabilities |
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Operating lease liability, long-term |
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Total liabilities |
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Stockholders’ equity |
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Preferred Stock, $ |
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Preferred Stock, $ |
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Voting Common Stock, $ |
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Additional paid-in capital |
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Accumulated deficit |
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Total stockholders’ equity |
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Total liabilities and stockholders’ equity |
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$ |
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$ |
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The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
4
FibroBiologics, Inc.
Condensed Consolidated Statements of Operations
(unaudited, in thousands, except shares and per share data)
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For the Three Months Ended September 30, |
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For the Nine Months Ended September 30, |
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2025 |
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2024 |
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2025 |
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2024 |
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Operating expenses: |
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Research and development |
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$ |
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$ |
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$ |
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$ |
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General, administrative and other |
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Total operating expenses |
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Loss from operations |
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( |
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( |
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( |
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( |
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Other income/(expense): |
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Change in fair value of warrant liability |
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Change in fair value of forward contract liability |
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Change in fair value of SEPA put option liability |
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Change in fair value of convertible debt |
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Commitment fee expenses |
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Other income/(expense) |
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( |
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Interest income |
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Interest expense |
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Total other income/(expense) |
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( |
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( |
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Net loss |
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$ |
( |
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$ |
( |
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$ |
( |
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$ |
( |
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Net loss per share, basic and diluted |
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$ |
( |
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$ |
( |
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$ |
( |
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$ |
( |
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Weighted-average shares outstanding, basic and diluted |
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The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
5
FibroBiologics, Inc.
Condensed Consolidated Statements of Changes in Stockholders’ Equity/(Deficit)
For the Three and Nine Months Ended September 30, 2025 and 2024
(unaudited, in thousands, except shares)
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Series A |
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Series B |
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Series B-1 |
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Series C |
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Non-voting |
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Voting |
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Additional |
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Accumulated |
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Total |
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Shares |
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Amount |
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Shares |
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Amount |
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Shares |
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Amount |
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Shares |
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Amount |
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Shares |
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Amount |
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Shares |
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Amount |
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Capital |
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Deficit |
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Equity |
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Balance – December 31, 2024 |
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— |
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$ |
— |
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— |
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$ |
— |
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— |
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$ |
— |
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$ |
— |
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— |
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$ |
— |
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$ |
— |
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$ |
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$ |
( |
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$ |
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Issuance of Voting Common Stock for commitment fee payable |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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Conversion of Short-term convertible debt into Voting Common Stock |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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Stock-based compensation expense |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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Net loss |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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( |
) |
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( |
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Balance (Unaudited) – March 31, 2025 |
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— |
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$ |
— |
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— |
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$ |
— |
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— |
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$ |
— |
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$ |
— |
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— |
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$ |
— |
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$ |
— |
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$ |
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$ |
( |
) |
$ |
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Conversion of Short-term convertible debt into Voting Common Stock |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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Stock-based compensation expense |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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Net loss |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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( |
) |
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( |
) |
Balance (Unaudited) – June 30, 2025 |
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— |
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$ |
— |
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— |
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$ |
— |
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— |
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$ |
— |
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$ |
— |
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— |
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$ |
— |
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$ |
— |
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$ |
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$ |
( |
) |
$ |
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Conversion of Short-term convertible debt into Voting Common Stock |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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Stock-based compensation expense |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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Net loss |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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( |
) |
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( |
) |
Balance (Unaudited) – September 30, 2025 |
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— |
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$ |
— |
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— |
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$ |
— |
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— |
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$ |
— |
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$ |
— |
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— |
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$ |
— |
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$ |
— |
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$ |
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$ |
( |
) |
$ |
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Series A |
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Series B |
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Series B-1 |
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Series C |
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Non-voting |
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Voting |
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Additional |
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Accumulated |
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Total |
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Shares |
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Amount |
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Shares |
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Amount |
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Shares |
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Amount |
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Shares |
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Amount |
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Shares |
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Amount |
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Shares |
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Amount |
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Capital |
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Deficit |
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Equity/(Deficit) |
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Balance – December 31, 2023 |
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$ |
— |
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$ |
— |
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$ |
— |
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— |
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$ |
— |
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$ |
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— |
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$ |
— |
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$ |
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$ |
( |
) |
$ |
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|||||||
Issuance of Series C Preferred Stock |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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Conversion of Series B Preferred Stock, Series B-1 Preferred Stock and Non-voting common stock to Voting Common Stock |
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— |
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— |
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( |
) |
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— |
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( |
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— |
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— |
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— |
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( |
) |
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( |
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— |
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— |
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— |
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Cancellation of Series A Preferred Stock upon Direct Listing |
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( |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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Sale of Voting Common Stock |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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Stock-based compensation expense |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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Net loss |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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( |
) |
|
( |
) |
Balance (Unaudited) – March 31, 2024 |
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— |
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$ |
— |
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— |
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$ |
— |
|
|
— |
|
$ |
— |
|
|
|
$ |
— |
|
|
— |
|
$ |
— |
|
|
|
$ |
— |
|
$ |
|
$ |
( |
) |
$ |
( |
) |
|||
Stock-based compensation expense |
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
|
|
— |
|
|
|
||
Net income |
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
|
|
|
||
Balance (Unaudited) – June 30, 2024 |
|
— |
|
$ |
— |
|
|
— |
|
$ |
— |
|
|
— |
|
$ |
— |
|
|
|
$ |
— |
|
|
— |
|
$ |
— |
|
|
|
$ |
— |
|
$ |
|
$ |
( |
) |
$ |
( |
) |
|||
Sale of Common Stock |
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
|
$ |
— |
|
|
|
|
— |
|
|
|
|||
Stock-based compensation expense |
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
|
|
— |
|
|
|
||
Net loss |
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
( |
) |
|
( |
) |
Balance (Unaudited) – September 30, 2024 |
|
— |
|
$ |
— |
|
|
— |
|
$ |
— |
|
|
— |
|
$ |
— |
|
|
|
$ |
— |
|
|
— |
|
$ |
— |
|
|
|
$ |
— |
|
$ |
|
$ |
( |
) |
$ |
|
||||
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
6
FibroBiologics, Inc.
Condensed Consolidated Statements of Cash Flows
(unaudited, in thousands)
|
|
For the Nine Months Ended September 30, |
|
|||||
|
|
2025 |
|
|
2024 |
|
||
Cash flows from operating activities |
|
|
|
|
|
|
||
Net loss |
|
$ |
( |
) |
|
$ |
( |
) |
Adjustments to reconcile net loss to net cash used in operating activities: |
|
|
|
|
|
|
||
Change in fair value of warrant liability |
|
|
|
|
|
( |
) |
|
Change in fair value of forward contract liability |
|
|
|
|
|
|
||
Change in fair value of SEPA put option liability |
|
|
( |
) |
|
|
|
|
Change in fair value of convertible debt |
|
|
|
|
|
|
||
Non-cash original discount on convertible debt |
|
|
|
|
|
|
||
Stock-based compensation expense |
|
|
|
|
|
|
||
Amortization of operating lease right-of-use asset |
|
|
|
|
|
|
||
Depreciation expense |
|
|
|
|
|
|
||
Changes in operating assets and liabilities: |
|
|
|
|
|
|
||
Prepaid expenses |
|
|
( |
) |
|
|
( |
) |
Accounts payable and accrued expenses |
|
|
( |
) |
|
|
( |
) |
Commitment fee payable |
|
|
|
|
|
|
||
Other current assets |
|
|
|
|
|
( |
) |
|
Other assets |
|
|
( |
) |
|
|
|
|
Payable to Parent |
|
|
|
|
|
( |
) |
|
Operating lease liability |
|
|
( |
) |
|
|
( |
) |
Net cash used in operating activities |
|
|
( |
) |
|
|
( |
) |
|
|
|
|
|
|
|
||
Cash flows from investing activities |
|
|
|
|
|
|
||
Purchases of property and equipment |
|
|
( |
) |
|
|
( |
) |
Net cash used in investing activities |
|
|
( |
) |
|
|
( |
) |
|
|
|
|
|
|
|
||
Cash flows from financing activities |
|
|
|
|
|
|
||
Proceeds from short-term convertible debt |
|
|
|
|
|
|
||
Repayments of short-term borrowing |
|
|
|
|
|
( |
) |
|
Proceeds from issuance of common stock, net of direct costs |
|
|
|
|
|
|
||
Net cash provided by financing activities |
|
|
|
|
|
|
||
|
|
|
|
|
|
|
||
Net decrease in cash and cash equivalents |
|
|
( |
) |
|
|
( |
) |
Cash and cash equivalents, beginning of period |
|
|
|
|
|
|
||
Cash and cash equivalents, end of period |
|
$ |
|
|
$ |
|
||
|
|
|
|
|
|
|
||
Supplemental disclosure of cash flow information: |
|
|
|
|
|
|
||
Cash paid for income taxes |
|
$ |
|
|
$ |
|
||
Cash paid for interest |
|
$ |
|
|
$ |
|
||
|
|
|
|
|
|
|
||
Supplemental disclosure of non-cash investing and financing activities: |
|
|
|
|
|
|
||
Settlement of forward contract liability for sale of shares to GEM pursuant to Draw Down and Closing Notices |
|
$ |
|
|
$ |
|
||
Right of use asset obtained in exchange for operating lease liability |
|
$ |
|
|
$ |
|
||
Issuance of Voting Common Stock for commitment fee payable |
|
$ |
|
|
$ |
|
||
Conversion of Short-term convertible debt into shares of common stock |
|
$ |
|
|
$ |
|
||
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
7
FibroBiologics, Inc.
Notes to the Unaudited Condensed Consolidated Financial Statements
September 30, 2025
1. Organization, Description of Business, and Liquidity
Organization and Business
FibroBiologics, Inc. (the “Company” or “FibroBiologics”) was originally formed as a limited liability company under the laws of the State of Texas on April 8, 2021 (“Inception”) and then converted to a Delaware corporation on December 14, 2021. FibroBiologics is an early stage, cell therapy company headquartered in Houston, Texas, developing innovative treatments for chronic diseases using fibroblast cells. The Company’s primary focus is the initiation and progression of preclinical studies and clinical-stage U.S. Food and Drug Administration trials related to fibroblast treatments for wound healing, multiple sclerosis, degenerative disc disease, psoriasis and certain cancers, and potential human longevity applications including thymic involution reversal. Prior to Inception, preclinical research and development related to these disease pathways took place under the parent company, SpinalCyte, LLC (the “Parent”).
Direct Listing
On January 31, 2024, the Company completed a direct listing of its common stock, $
Formation of Wholly-Owned Subsidiary
On June 12, 2025, the Company formed a wholly-owned subsidiary, FibroBiologics Australia Pty Ltd. This entity will act as the local sponsor for the Company's twelve-week Phase 1/2 clinical trial utilizing CYWC628 for treatment of diabetic foot ulcers in Australia.
Going Concern and Management’s Plan
The Company has incurred operating losses since Inception and expects such losses to continue in the future as it builds infrastructure, develops intellectual property, and conducts research and development activities. The Company has primarily relied on a combination of angel investors, private debt placements, convertible debt issuances, and sales of equity to fund its operations. As of September 30, 2025, the Company had an accumulated deficit of $
Segments
Operating segments are defined as components of an entity for which separate discrete financial information is made available and that is regularly evaluated by the chief operating decision maker (“CODM”) in making decisions regarding resource allocation and assessing performance. The Company is a clinical-stage cell therapy company with a limited number of employees working on fibroblast-based targets. The Company’s operations are organized and reported as a single reportable segment, which includes all activities related to the discovery, development, and commercialization of its products. The Company’s CODM, its , reviews operating results on an aggregate basis and manages the operations as a single operating segment.
The accounting policies of the Company’s single operating and reportable segment are the same as those described in the summary of significant accounting policies. The measure of segment assets is reported on the condensed consolidated balance sheets as total assets.
2. Summary of Significant Accounting Policies
Basis of Presentation
8
The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“GAAP”) for interim financial information and in accordance with the instructions to Form 10-Q and Article 8 of Regulation S-X of the rules and regulations of the U.S. Securities and Exchange Commission (“SEC”). The accompanying unaudited condensed consolidated balance sheet as of September 30, 2025, unaudited condensed consolidated statements of operations for the three and nine months ended September 30, 2025 and 2024, unaudited condensed consolidated statements of changes in stockholders’ equity/(deficit) for the three and nine months ended September 30, 2025 and 2024, and unaudited condensed consolidated statements of cash flows for the nine months ended September 30, 2025 and 2024, are unaudited. Accordingly, they do not include all of the information and footnotes required by GAAP for complete financial statements. The accompanying unaudited condensed consolidated financial statements should be read in conjunction with the Company’s Annual Report on Form 10-K for the year ended December 31, 2024 as filed with the SEC on March 31, 2025, which contains the audited financial statements and notes thereto. The 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 (consisting of normal recurring adjustments) necessary to state fairly the Company’s financial position as of September 30, 2025, the results of operations for the three and nine months ended September 30, 2025 and 2024, the unaudited condensed consolidated statements of changes in stockholders’ equity/(deficit) for the three and nine months ended September 30, 2025 and 2024, and the unaudited condensed consolidated statements of cash flows for the nine months ended September 30, 2025 and 2024. The December 31, 2024 condensed consolidated balance sheet included herein was derived from the audited financial statements, but it does not include all disclosures or notes required by GAAP for complete financial statements.
Interim results are not necessarily indicative of results for an entire year or for any future period.
Principles of Consolidation
The accompanying unaudited consolidated condensed financial statements, which include the accounts of the Company and its wholly-owned subsidiary, FibroBiologics Australia Pty Ltd, have been prepared in accordance with GAAP for interim financial information and with the instructions to Form 10-Q and Article 10 of Regulation S-X. All significant intercompany balances and transactions are eliminated in consolidation.
Use of Estimates
The preparation of the unaudited condensed consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the unaudited condensed consolidated financial statements and the reported amounts of expenses during the reporting periods. These estimates are based on information available as of the date of the unaudited condensed consolidated financial statements; therefore, actual results could differ from those estimates and assumptions. The most significant estimates include the warrant liability, fair value of forward contract liability, SEPA put option liability, fair value of the short-term convertible debt, and stock-based compensation.
Fair Value Option of Accounting
The Company has elected the option under Accounting Standards Codification ("ASC") 825-10, Financial Instruments (“ASC 825”), to measure its short-term convertible debt issued pursuant to the SEPA (see Note 7) at fair value. The fair value option may be elected on an instrument-by-instrument basis and is irrevocable unless a new election date occurs. When the fair value option is elected for an instrument, unrealized gains and losses for such instrument are reported in the condensed consolidated statements of operations at each subsequent reporting date. Up-front costs and fees related to items for which the fair value option is elected shall be recognized in earnings as incurred and not deferred. These amounts are included in other income/(expense) in the condensed cosolidated statements of operations.
Concentration of Credit Risk
Financial instruments that potentially subject the Company to concentrations of credit risk consist principally of cash and cash equivalents. The Company has significant cash balances at financial institutions, which, throughout the year, regularly exceed the federally insured limit of $
Risks and Uncertainties
The Company is subject to certain risks and uncertainties, including, but not limited to, changes in any of the following areas that the Company believes could have a material adverse effect on the future financial position or results of operations: the timing of, and the Company’s ability to advance its current and future product candidates into and through clinical development; costs and timelines associated with the manufacture of clinical supplies of the Company’s product candidates; regulatory approval and market acceptance of its product candidates; performance of third-party contract research organizations (“CROs”) and contract manufacturing organizations (“CMOs”); competition from pharmaceutical companies with greater financial resources or expertise; protection of the intellectual property, litigation or claims against the Company based on intellectual property, or other factors; the need to obtain additional funding; and its ability to attract and retain employees necessary to support its growth. Disruption from the operations of CROs, CMOs or suppliers would likely have a negative impact on the Company’s business, financial position, and results of operations.
Cash and Cash Equivalents
Cash and cash equivalents consist of unrestricted cash balances and short-term, liquid investments with an original maturity date of three months or less at the time of purchase. The Company had $
Property and Equipment
9
Property and equipment are stated at cost, net of accumulated depreciation. Depreciation of property and equipment is computed using the straight-line method over the estimated useful lives of the respective assets, generally to
Property and equipment are reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount of the assets might not be recoverable. Conditions that would necessitate an impairment assessment include a significant decline in the observable market value of an asset, a significant change in the extent or manner in which an asset is used, or a significant adverse change that would indicate that the carrying amount of an asset or group of assets is not recoverable. For long-lived assets to be held and used, the Company will recognize an impairment loss only if the carrying amount is not recoverable through its undiscounted cash flows and measure any impairment loss based on the difference between the carrying amount and estimated fair value. There were
Leases
The Company determines if an arrangement is a lease at inception. An arrangement is or contains a lease if it conveys the right to control the use of an identified asset for a period of time in exchange for consideration. If a lease is identified, classification is determined at lease commencement. Operating lease liabilities are recognized at the present value of the future lease payments at the lease commencement date. The Company’s leases do not provide an implicit interest rate and therefore the Company estimates its incremental borrowing rate to discount lease payments. The incremental borrowing rate reflects the interest rate that the Company would have to pay to borrow on a collateralized basis an amount equal to the lease payments in a similar economic environment over a similar term. Operating lease right-of-use (“ROU”) assets are based on the corresponding lease liability adjusted for any lease payments made at or before commencement, initial direct costs, and lease incentives. Renewals or early terminations are not accounted for unless the Company is reasonably certain to exercise these options. Operating lease expense is recognized and the ROU asset is amortized on a straight-line basis over the lease term.
Operating leases are included in operating lease right-of-use asset, operating lease liability, short-term, and operating lease liability, long-term on the Company’s unaudited condensed consolidated balance sheets.
The Company has elected in accordance with ASC 842-20-25-2 an accounting policy to not record short-term leases, defined as those with terms of 12 months or less, on the unaudited condensed consolidated balance sheets. Rent expense recorded under leases, for financial statement purposes, is recognized on a straight-line basis over the lease term based on the most recent contractual terms available.
Fair Value Measurements
ASC 820, Fair Value Measurement, establishes a fair value hierarchy for instruments measured at fair value that distinguishes between assumptions based on market data (observable inputs) and the Company’s own assumptions (unobservable inputs). Observable inputs are inputs that market participants would use in pricing the asset or liability based on market data obtained from sources independent of the Company. Unobservable inputs are inputs that reflect the Company’s assumptions about the inputs that market participants would use in pricing the assets or liability and are developed based on the best information available in the circumstances. ASC 820 identifies fair value 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. As a basis for considering market participant assumptions in fair value measurements, ASC 820 establishes a three-tiered value hierarchy that distinguishes between the following:
Level 1 - Quoted market prices in active markets for identical assets or liabilities.
Level 2 - Inputs other than Level 1 inputs that are either directly or indirectly observable, such as quoted market prices, interest rates, and yield curves.
Level 3 - Unobservable inputs for the asset or liability (i.e., supported by little or no market activity). Level 3 inputs include management’s own assumptions about the assumptions that market participants would use in pricing the asset or liability (including assumptions about risk).
Categorization within the valuation hierarchy is based upon the lowest level of input that is significant to the fair value measurement.
Derivatives
Derivative financial instruments are recorded at fair value on the unaudited condensed consolidated balance sheets. Liability classified derivatives are remeasured at their fair value at each reporting date, with decreases or increases in the fair value recognized as other gain or loss, respectively, within the unaudited condensed consolidated statements of operations. Equity classified derivatives are not remeasured at each reporting date. If a liability classified derivative becomes eligible for reclassification to an equity classified derivative, any gains or losses recognized up to the point of reclassification are not reversed.
Research and Development
Research and development costs are charged to expense as incurred. Research and development costs consist of costs incurred in performing research and development activities, including salaries and bonuses, scientist recruiting costs, employee benefits, facilities costs, laboratory supplies, manufacturing expenses, preclinical expenses, research materials, and consulting and other contracted services. Costs for certain research and
10
development activities are recognized based on the terms of the individual arrangements, which may differ from the pattern of costs incurred, and are reflected in the unaudited condensed consolidated financial statements as prepaid or accrued research and development.
Marketing and Advertising Costs
Marketing and advertising costs to promote the Company and its product candidates are expensed as incurred. Marketing and advertising expenses were $
Patent Costs
As the Company continues to incur costs to obtain market approval of patented technology, patent costs are expensed as incurred in general, administrative and other expense in the unaudited condensed consolidated statements of operations. Costs include fees to renew or extend the term of recognized intangible assets, patent defense costs, and patent application costs. Management will continue to expense such costs until market approval is obtained through regulatory approval by the appropriate governing body.
Income Taxes
The Company is a C corporation, and accounts for income taxes under the asset and liability method. Under this method, deferred tax assets and liabilities are determined based on the difference between the financial statement and tax basis of assets and liabilities using enacted tax rates in effect for the year in which the differences are expected to reverse. Valuation allowances are established when necessary to reduce deferred tax assets to an amount that is more likely than not to be realized.
Under the provisions of ASC 740-10, Income Taxes, the Company evaluates uncertain tax positions by reviewing against applicable tax law all positions taken by the Company with respect to tax years for which the statute of limitations is still open. ASC 740-10 provides that a tax benefit from an uncertain tax position may be recognized when it is more likely than not that the position will be sustained upon examination, including resolutions of any related appeals or litigation processes, based on the technical merits. The Company recognizes interest and penalties related to the liability for unrecognized tax benefits, if any, as a component of the income tax expense line in the accompanying unaudited condensed consolidated statements of operations.
In July 2025, the One Big Beautiful Bill Act (the "Tax Act") was enacted, introducing a series of corporate tax changes in the U.S., including 100% bonus depreciation on qualified property and full expensing for research and development expenditures. The impacts of the Tax Act are reflected in the Company's results for the fiscal quarter ended September 30, 2025, and there was no material impact to income tax expense or effective tax rate.
Stock-Based Compensation
The Company recognizes compensation costs related to stock options granted to employees and nonemployees based on the estimated fair value of the awards on the date of grant and recognizes expense on a straight-line basis over the requisite service period, which is generally the vesting period of the award. Forfeitures are recognized as they occur. The fair value of stock options is estimated on the date of grant using a Black-Scholes option pricing model which requires management to apply judgment and make estimates, including:
Emerging Growth Company
The Company is an emerging growth company (“EGC”), as defined in the Jumpstart Our Business Startups Act of 2012 (“JOBS Act”). Under the JOBS Act, an EGC can delay adopting new or revised accounting standards issued subsequent to the enactment of the JOBS Act until such time as
11
those standards apply to private companies. The Company has elected to use this extended transition period for complying with new or revised accounting standards that have different effective dates for public and private companies; however, the Company may adopt new or revised accounting standards early if the standard allows for early adoption.
In addition, the Company will utilize other exemptions and reduced reporting requirements provided to EGCs by the JOBS Act. Subject to certain conditions set forth in the JOBS Act, an EGC is not required to, among other things, (i) provide an auditor’s attestation report on the Company’s system of internal controls over financial reporting pursuant to Section 404(b) of the Sarbanes-Oxley Act of 2002, (ii) provide all of the compensation disclosure that may be required of non-EGC 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 financial statements (auditor discussion and analysis), or (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.
Recently Issued Accounting Pronouncements
In December 2023, the Financial Accounting Standards Board ("FASB") issued Accounting Standards Update ("ASU") No. 2023-09, Income Taxes (Topic 740) – Improvements to Income Tax Disclosures (“ASU 2023-09”), which is intended to improve the transparency of income tax disclosures by greater disaggregation of information in the rate reconciliation and income taxes paid disaggregated by jurisdiction. The standard is effective for public companies for fiscal years beginning after December 15, 2024, with early adoption permitted. The Company has determined that there is no impact that the adoption of ASU 2023-09 has had on its condensed consolidated financial statements.
In November 2024, the FASB issued ASU No. 2024-03, Income Statement – Reporting Comprehensive Income – Expense Disaggregation Disclosures (Subtopic 220-40) – Disaggregation of Income Statement Expenses (“ASU 2024-03”), which is intended to require more detailed disclosures about specified categories of expenses (including employee compensation, depreciation, and amortization) included in certain expense captions presented on the face of the income statement. ASU 2024-03 is effective for annual periods beginning after December 15, 2026, and interim reporting periods beginning after December 15, 2027. Early adoption is permitted. The amendments may be applied either prospectively to financial statements issued for reporting periods after the effective date of this ASU or retrospectively to all prior periods presented in the financial statements. The Company is in the process of evaluating the impact of this new guidance on its condensed consolidated financial statements.
3. Net Loss per Share Attributable to Common Stockholders
The following table summarizes the computation of basic and diluted net loss per share attributable to common stockholders of the Company:
|
|
Three Months Ended September 30, |
|
|
Nine Months Ended September 30, |
|
||||||||||
(in thousands, except share and per share amounts) |
|
2025 |
|
|
2024 |
|
|
2025 |
|
|
2024 |
|
||||
Numerator: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Net loss |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
Denominator: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Weighted-average number of common shares outstanding, basic and diluted |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Net loss per common share attributable to common stockholders, basic and diluted |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
As further described in Note 7, during the nine months ended September 30, 2025, the Company issued
4. Property and Equipment
Property and equipment, net consist of the following:
|
|
September 30, |
|
|
December 31, |
|
||
(in thousands) |
|
2025 |
|
|
2024 |
|
||
Laboratory equipment |
|
$ |
|
|
$ |
|
||
Computer equipment, software, and other |
|
|
|
|
|
|
||
Total property and equipment at cost |
|
|
|
|
|
|
||
Less: Accumulated depreciation |
|
|
( |
) |
|
|
( |
) |
Property and equipment, net |
|
$ |
|
|
$ |
|
||
12
The useful life of laboratory equipment is
5. Fair Value of Financial Instruments
The following tables summarize the Company’s financial assets and liabilities measured at fair value on a recurring basis based on the three-tier fair value hierarchy:
|
|
Fair Value Measurement as of September 30, 2025 |
|
|||||||||||||
(in thousands) |
|
Level 1 |
|
|
Level 2 |
|
|
Level 3 |
|
|
Total |
|
||||
Assets: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Cash equivalents |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
Total assets fair value |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Liabilities: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
SEPA put option liability |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
Short-term convertible debt |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Total liabilities fair value |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
|
|
Fair Value Measurement as of December 31, 2024 |
|
|||||||||||||
(in thousands) |
|
Level 1 |
|
|
Level 2 |
|
|
Level 3 |
|
|
Total |
|
||||
Assets: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Cash equivalents |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
Total assets fair value |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Liabilities: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
SEPA put option liability |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
Short-term convertible debt |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Total liabilities fair value |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
The following table summarizes the activity related to Level 3 financial liabilities for the nine months ended September 30, 2025:
(in thousands) |
|
Short-term |
|
|
SEPA Put |
|
||
Fair value at December 31, 2024 |
|
$ |
|
|
$ |
|
||
Change in fair value of SEPA put option liability |
|
|
|
|
|
( |
) |
|
Addition of short-term convertible debt |
|
|
|
|
|
|
||
Conversions of convertible debt into shares of common stock |
|
|
( |
) |
|
|
|
|
Change in fair value of convertible debt |
|
|
|
|
|
|
||
Fair value at September 30, 2025 |
|
$ |
|
|
$ |
|
||
The following table summarizes the activity related to Level 3 financial liabilities for the nine months ended September 30, 2024:
(in thousands) |
|
Liability Instrument |
|
|
Forward Contract Liability |
|
|
Warrant Liability |
|
|||
Fair value at December 31, 2023 |
|
$ |
|
|
$ |
|
|
$ |
|
|||
Bifurcation of the liability instrument upon Direct Listing |
|
|
( |
) |
|
|
|
|
|
|
||
Increase in forward contract liability for Draw Down Notice on June 27, 2024 |
|
|
|
|
|
|
|
|
|
|||
Change in fair value of Forward contract liability |
|
|
|
|
|
( |
) |
|
|
|
||
Increase in Warrant liability at issuance January 31, 2024 |
|
|
|
|
|
|
|
|
|
|||
Change in fair value of Warrant liability |
|
|
|
|
|
|
|
|
( |
) |
||
Fair value at September 30, 2024 |
|
$ |
|
|
$ |
|
|
$ |
|
|||
As further described in Note 7, the Company issued short-term convertible debt on December 20, 2024 and December 30, 2024 with a total principal balance of $
13
respectively, and a volatility of
As further described in Note 7, the Company entered into the SEPA on December 20, 2024 and recorded a put option liability for the Company’s right, subject to the satisfaction of the conditions to the investor's purchase obligations set forth therein, to require the investor to purchase up to an additional $
The carrying amounts of cash, prepaid expenses, other current assets, accounts payable and accrued expenses approximate their fair values due to their short-term maturities.
There were no transfers in or out of Level 1, Level 2 or Level 3 assets and liabilities for the nine months ended September 30, 2025 and for the year ended December 31, 2024.
6. Stockholders’ Equity/(Deficit)
Authorized Capital - As of September 30, 2025, the Company authorized
In January 2024, the Company issued
On January 31, 2024, the Company completed its Direct Listing, which qualified as an IPO transaction pursuant to the Company’s Amended and Restated Certificate of Incorporation. As a result of the Direct Listing, the outstanding shares of Series A Preferred Stock were canceled for no consideration and the outstanding shares of Series B Preferred Stock, Series B-1 Preferred Stock, and non-voting Common Stock were all converted 1:1 into shares of voting Common Stock.
In August 2024, the Company amended and restated its certificate of incorporation with the State of Delaware to eliminate its non-voting Common Stock, Series A Preferred Stock, Series B Preferred Stock, and Series B-1 Preferred Stock, and to reduce to
In June 2025, the Company amended and restated its certificate of incorporation with the State of Delaware to increase its authorized Common Stock, par value $
7. Standby Equity Purchase Agreement
On December 20, 2024, the Company entered into the Standby Equity Purchase Agreement (the "SEPA"). Pursuant to the SEPA, the investor will advance to the Company, subject to the satisfaction of certain conditions, a total principal amount of $
The Company received net proceeds of $
14
Below is a summary of conversions during the nine months ended September 30, 2025.
Date |
|
Tranche |
|
Principal Amount |
|
|
Shares Issued |
|
|
Price Per Share |
|
|||
January 23, 2025 |
|
Second Note |
|
$ |
|
|
|
|
|
$ |
|
|||
January 27, 2025 |
|
Second Note |
|
$ |
|
|
|
|
|
$ |
|
|||
January 29, 2025 |
|
Second Note |
|
$ |
|
|
|
|
|
$ |
|
|||
February 7, 2025 |
|
Second Note |
|
$ |
|
|
|
|
|
$ |
|
|||
February 21, 2025 |
|
Second Note |
|
$ |
|
|
|
|
|
$ |
|
|||
March 4, 2025 |
|
Second Note |
|
$ |
|
|
|
|
|
$ |
|
|||
April 11, 2025 |
|
Second Note |
|
$ |
|
|
|
|
|
$ |
|
|||
April 15, 2025 |
|
Second Note |
|
$ |
|
|
|
|
|
$ |
|
|||
May 15, 2025 |
|
Second Note |
|
$ |
|
|
|
|
|
$ |
|
|||
June 2, 2025 |
|
Second Note |
|
$ |
|
|
|
|
|
$ |
|
|||
June 3, 2025 |
|
Second Note |
|
$ |
|
|
|
|
|
$ |
|
|||
June 20, 2025 |
|
Second Note |
|
$ |
|
|
|
|
|
$ |
|
|||
June 24, 2025 |
|
Second Note |
|
$ |
|
|
|
|
|
$ |
|
|||
June 26, 2026 |
|
Third Note |
|
$ |
|
|
|
|
|
$ |
|
|||
June 27, 2025 |
|
Third Note |
|
$ |
|
|
|
|
|
$ |
|
|||
July 15, 2025 |
|
Third Note |
|
$ |
|
|
|
|
|
$ |
|
|||
July 28, 2025 |
|
Third Note |
|
$ |
|
|
|
|
|
$ |
|
|||
August 1, 2025 |
|
Third Note |
|
$ |
|
|
|
|
|
$ |
|
|||
August 18, 2025 |
|
Third Note |
|
$ |
|
|
|
|
|
$ |
|
|||
August 25, 2025 |
|
Third Note |
|
$ |
|
|
|
|
|
$ |
|
|||
September 9, 2025 |
|
Third Note |
|
$ |
|
|
|
|
|
$ |
|
|||
September 16, 2025 |
|
Third Note |
|
$ |
|
|
|
|
|
$ |
|
|||
September 25, 2025 |
|
Third Note |
|
$ |
|
|
|
|
|
$ |
|
|||
September 30, 2025 |
|
Third Note |
|
$ |
|
|
|
|
|
$ |
|
|||
The Company recognized a net loss of $
Pursuant to the SEPA, and subject to certain conditions, the Company will have the right, from time to time, until December 20, 2026, to require the investor to purchase up to an additional $
The Company paid the investor a structuring fee of $
The SEPA was accounted for as a liability under ASC 815 because it includes an embedded put option and an embedded forward option. The put option was recognized at inception and the forward option will be recognized upon the issuance of a notice for the sale of the Company’s Common Stock. The fair value of the derivative liability related to the embedded put option was estimated at $
8. Income Taxes
The Company did
9. Leases, Commitments and Contingencies
In October 2022, the Company entered into a lease agreement for office space with a term of
15
In June 2023, the Company entered into a new lease for temporary lab and office space for its research operations. This lease had a term of
In March 2025, the Company executed a new lease for
Rent expense for the nine months ended September 30, 2025 and 2024 was $
Maturities of operating lease liability as of September 30, 2025 were as follows:
(in thousands of dollars) |
|
|
|
|
2026 |
|
$ |
|
|
2027 |
|
|
|
|
2028 |
|
|
|
|
2029 |
|
|
|
|
2030 |
|
|
|
|
Thereafter |
|
|
|
|
Total lease payments |
|
|
|
|
Less: Imputed interest |
|
|
( |
) |
Total lease liability |
|
|
|
|
Less: Current lease liability |
|
|
( |
) |
Total non-current lease liability |
|
$ |
|
|
10. Stock-Based Compensation
The Company adopted on August 10, 2022, and the stockholders approved on August 18, 2022, the 2022 Stock Plan (the “Plan”). The Plan provides for the grant of incentive stock options, nonstatutory stock options, stock appreciation rights, restricted stock awards, restricted stock unit awards, and other stock awards.
As of September 30, 2025 and December 31, 2024, respectively, there were
Stock-based compensation expense is recognized in the condensed consolidated statements of operations as follows:
|
|
For the Three Months Ended September 30, |
|
|
For the Nine Months Ended September 30, |
|
||||||||||
(in thousands of dollars) |
|
2025 |
|
|
2024 |
|
|
2025 |
|
|
2024 |
|
||||
Research and development |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
General and administrative |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Total stock-based compensation expense |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
In addition to the $
Unrecognized stock-based compensation costs related to unvested awards and the weighted-average period over which the costs are expected to be recognized as of September 30, 2025, are as follows:
|
|
Stock Options |
|
|
Unrecognized stock-based compensation expense (in thousands) |
|
$ |
|
|
Expected weighted-average period compensation costs to be recognized (years) |
|
|
|
|
A summary of the Company’s stock option activity is as follows:
16
|
|
Stock Options |
|
|
Weighted-Average Exercise Price per Share |
|
|
Weighted-Average Remaining Contractual Life (years) |
|
|
Aggregate Intrinsic Value (in thousands) |
|
||||
Outstanding as of December 31, 2024 |
|
|
|
|
$ |
|
|
|
|
|
$ |
|
||||
Granted |
|
|
|
|
$ |
|
|
|
|
|
$ |
|
||||
Exercised |
|
|
|
|
$ |
|
|
|
— |
|
|
$ |
— |
|
||
Forfeited/canceled |
|
|
( |
) |
|
$ |
|
|
|
— |
|
|
$ |
— |
|
|
Outstanding as of September 30, 2025 |
|
|
|
|
$ |
|
|
|
|
|
$ |
|
||||
Exercisable as of September 30, 2025 |
|
|
|
|
$ |
|
|
|
|
|
$ |
|
||||
The fair value of stock options granted to employees, directors, and consultants was estimated on the date of grant using the Black-Scholes option pricing model using the following weighted-average assumptions:
Assumptions: |
|
Nine Months Ended |
|
|
Nine Months Ended |
|
Risk-free interest rate |
|
|
|
|||
Expected volatility |
|
|
|
|||
Expected term (years) |
|
|
|
|
||
Expected dividend |
|
|
|
|||
The weighted-average grant date fair value of the options granted during the nine months ended September 30, 2025 and 2024 was $
11. Related Party Transactions
During the three and nine months ended September 30, 2025, the Company paid an aggregate of $
12. Subsequent Events
On October 14, 2025, the investor converted $
On October 15, 2025, the investor converted $
On October 16, 2025, the investor converted $
On October 20, 2025, the investor converted $
On October 21, 2025, the investor converted $
On October 27, 2025, the investor converted $
17
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations
You should read the following discussion and analysis of our financial condition and results of operations together with our unaudited financial statements and related notes and other financial information appearing elsewhere in this Quarterly Report and with our audited financial statements and related notes and other financial information appearing in our Annual Report. Some of the information contained in this discussion and analysis or set forth elsewhere in this Quarterly Report, including information with respect to our plans and strategy for our business, includes forward-looking statements that involve risks and uncertainties. As a result of many factors, including those factors set forth in the “Risk Factors” section of this Quarterly Report and in the Annual Report, our actual results could differ materially from the results described in or implied by the forward-looking statements contained in the following discussion and analysis.
Overview
We are a clinical-stage biotechnology company focused on developing and commercializing fibroblast-based therapies for patients suffering from chronic diseases with significant unmet medical needs, including wound healing, multiple sclerosis, degenerative disc disease, psoriasis, certain cancers, and potential human longevity applications including thymic involution reversal using a thymic organoid. Our most advanced product candidates are CYWC628, CYPS317, CYMS101 and CybroCell™.
We have completed our IND-enabling pre-clinical studies for the development of CYWC628 as a topically administered allogeneic fibroblast cell-based therapy for wound healing. Our pre-clinical studies focused on utilizing single cell fibroblasts, fibroblast spheroids, and fibroblast-derived materials to treat wounds in diabetic mice. We completed pre-clinical studies investigating (i) multiple administrations of CYWC628 spheroids on a chemically induced chronic wound NONcNZO10/LtJ and BKS.Cg-Dock7m +/+ LepRdb/J mouse model, (ii) dose titration to provide information on the proposed dose range of CYWC628, and (iii) acute and chronic toxicity. The results of our studies have shown statistically significant acceleration in the rate of wound closure, and statistically significant improvement in the quality of the healed wounds in comparison with both a marketed wound care product and control.
We are developing CYMS101 as an intravenously administered allogeneic fibroblast single cell, and fibroblast spheroid cell-based therapy to treat MS. After completing animal studies using CYMS101, we received approval from a U.S.-based IRB to conduct clinical investigations in Mexico using the fibroblast cell composition for patients with MS, and completed a Phase 1 study. The study was conducted in five participants. The primary objective of the study was to assess safety, and the secondary objective was to assess efficacy. The primary objective was achieved as we saw no adverse events related to the treatment - no adverse events during intravenous injection of the tolerogenic fibroblasts, no short or long-impact in complete blood count tests during the 16-week monitoring period, and no short or long impact in electrocardiogram results during the 16-week monitoring period. In addition, the study assessed clinical activity using a standard set of neurological assessments routinely used to assess MS. We are currently conducting further research to more fully characterize the mode of action of fibroblasts in oligodendrocyte expansion. We plan to file an IND application for a Phase 1/2 clinical trial relating to MS in the United States in the fourth quarter of 2025. We expect to seek a strategic partner to collaborate with us on the development of CYMS101 either before initiating the Phase 1/2 study, or after its completion, if successful, and prior to commencing a potential Phase 3 clinical trial.
CybroCell™ is an investigational intradiscal administered allogeneic fibroblast cell-based therapy in development for degenerative disc disease and is being designed as an alternative method for repairing the cartilage of the intervertebral disc (or any other articular cartilage). We have completed two animal studies in rabbit models. The results from the studies were positive and supported our IND application to run a “first in human” trial. We received IND clearance from the FDA in 2018, conditional upon approval of our master cell bank, to evaluate this candidate in a planned clinical trial.
CYPS317 is our allogeneic intravenously administered fibroblast spheroid cell-based investigational therapeutic for the treatment of psoriasis. We have completed preliminary IND-enabling pre-clinical studies utilizing chronic and acute psoriasis mouse models to assess the potential use of intravenous administration of fibroblast spheroids for the treatment of psoriasis. We are continuing our IND-enabling animal model studies to determine the optimal efficacious dose range and the durability of treatment for mild to moderate, and moderate to severe, psoriasis, which we expect to complete in the fourth quarter of 2025. We plan to file an IND following completion of these studies if the results support continued development.
We also have human longevity, certain cancers, and artificial pancreatic organoid research programs in the very early stages of research and development. We plan to accelerate such programs as funding allows.
The manufacturing of our master cell bank and working cell bank for CYWC628 is now complete and both are certified as released by our CDMO. This CDMO will also manufacture CYWC628 for use in our twelve-week Phase 1/2 clinical trial for treatment of diabetic foot ulcers that we will conduct in Australia. If any of our product candidates receive marketing approval, we expect to evaluate the feasibility of building our own cGMP manufacturing facility or continuing to outsource manufacturing to a CDMO for clinical testing and commercial supply. We expect to rely on third parties for our cell therapy manufacturing process for the foreseeable future.
Since our April 2021 separation from SpinalCyte, LLC (also known as FibroGenesis), our activities have consisted primarily of (i) corporate and strategic planning, (ii) recruiting and retaining personnel, (iii) financing our operations, (iv) prosecuting, maintaining and expanding our intellectual property portfolio, and (v) conducting preclinical and other research and development related to our product candidates. These activities allow us to continue building our fibroblast cell-based therapy platform.
We have incurred net losses since inception and expect to incur losses in the future as we continue our research and development activities. To date, we have funded our operations primarily through investment from FibroGenesis, the sale of $15.0 million of our convertible promissory notes, which were all subsequently converted to equity, the sale of $18.6 million of preferred stock, $10.4 million in proceeds from the sale of common stock, $0.00001 par value per shares, or the Common Stock, through the share purchase agreement, dated November 12, 2021, or the GEM SPA, with GEM
18
Global Yield LLC SCS, or GEM Global, and GEM Yield Bahamas Limited, or GYBL, and together with GEM Global, GEM, and $13.1 million in proceeds from the issuance of additional convertible promissory notes.
As of September 30, 2025, we had cash and cash equivalents of $4.9 million. Since our inception, we have incurred significant operating losses. We incurred net losses of $15.4 million and $8.1 million for the nine months ended September 30, 2025 and 2024, respectively. As of September 30, 2025, we had an accumulated deficit of $50.9 million.
We expect to continue to incur significant losses for the foreseeable future, and we expect these losses to increase substantially if and as we:
Due to the numerous risks and uncertainties associated with biopharmaceutical product development and the economic and developmental uncertainty, we may be unable to accurately predict the timing or magnitude of all expenses. Our ability to ultimately generate revenue to achieve profitability will depend heavily on the development, approval, and subsequent commercialization of our product candidates. If we fail to become profitable or are unable to sustain profitability on a continuing basis, then we may be unable to continue our operations at planned levels and be forced to reduce or terminate our operations. As a result, we will need substantial additional funding to our support short-term and long-term continuing operations and pursue our growth strategy. Until such time as we can generate significant revenue from product sales, if ever, we expect to finance our operations through the sale of equity, debt financings or other capital sources, which may include collaborations with other companies or other strategic transactions. We may not be able to raise additional funds or enter into such other agreements or arrangements when needed on favorable terms, or at all. If we fail to raise capital or enter into such agreements as and when needed, we will have to significantly delay, reduce, or eliminate the development and commercialization of one or more of our product candidates or delay our pursuit of potential in-licenses or acquisitions.
General Trends and Outlook
Recent Developments
CYWC628
Based upon our progress to date, we expect to initiate our twelve-week Phase 1/2 clinical trial utilizing CYWC628 for treatment of diabetic foot ulcers in Australia in the first quarter of 2026 and we expect to complete the clinical trial in the third quarter of 2026. These timelines have been extended as we work to resolve process issues with the manufacturing training runs and increase the number of aseptic process simulation runs needed to confirm sterility of the manufacturing process before we begin the manufacturing of CYWC628 for the clinical trial. Please see “Risk Factors – Risks Related to Manufacturing” in our Annual Report and “Item 1A. Risk Factors – Risks Related to Manufacturing” in this Quarterly Report.
CybroCell™
We successfully carried out experiments that demonstrated the ability to use the CYWC628 spheroid master cell bank for the manufacturing of the CybroCell™ drug product. Animal trials are currently underway to confirm that the therapeutic effects of the CYWC628 spheroids are similar to those of single-cell fibroblasts, which supported our IND clearance with the FDA for the planned Phase I clinical trial. If the animal trial results demonstrate similarity of therapeutic effects, we will work to amend the IND clearance with the FDA to replace single-cell fibroblasts with CYWC628 spheroids. A timeline for the trial will be determined in connection with discussions with the FDA.
Components of Results of Operations
Revenue
19
To date, we have not generated any revenue from product sales and do not expect to generate any revenue from the sale of products in the foreseeable future. If our development efforts for any of our product candidates are successful and result in regulatory approval, we may generate revenue in the future from product sales. We cannot predict if, when or to what extent we will generate revenue from the commercialization and sale of any of our product candidates. We may never succeed in obtaining regulatory approval for any of our product candidates and, even if we do, we may never generate revenue that is significant enough for us to achieve profitability.
Research and Development Expenses
Our research and development expenses consist of expenses incurred in connection with the development of our product candidates and include:
We expense research and development costs as incurred. Nonrefundable advance payments that we make for goods or services to be received in the future for use in research and development activities are recorded as prepaid expenses. The prepaid amounts are expensed as the related goods are delivered or the services are performed.
We expect our research and development expenses to increase substantially for the foreseeable future as we continue to invest in research and development activities related to developing our product candidates as they advance into later stages of clinical development and our other product candidates in preclinical development as they advance into clinical development. The process of conducting the necessary clinical research to obtain regulatory approval is costly and time-consuming, and the successful development of our product candidates is highly uncertain. As a result, we are unable to determine the duration and completion costs of our research and development projects or when and to what extent we will generate revenue from the commercialization and sale of any of our product candidates. This is due to the numerous risks and uncertainties associated with developing product candidates, including uncertainty related to:
A change in the outcome of any of these variables with respect to the development of any of our programs or any product candidate we develop would significantly change the costs, timing and viability associated with the development and/or regulatory approval of such programs or product candidates.
20
General, Administrative and Other Expenses
Our general, administrative, and other expenses consist primarily of personnel costs, allocated facilities costs, and other expenses for outside professional services, including legal, marketing, investor relations, human resources services, and accounting services. Personnel costs consist of salaries, benefits, and stock-based compensation for our general and administrative personnel. We expect to continue incurring additional expenses as a result of operating as a public company, including expenses related to compliance with the rules and regulations of the SEC and Nasdaq, insurance, investor relations activities and other administrative and professional services. We also expect to increase the size of our administrative function to support the growth of our business.
Interest Expense
Our interest expense consists primarily of interest on short-term borrowing to finance D&O insurance premiums.
Statements of Operations
Results of Operations
Comparison of Three Months Ended September 30, 2025 and 2024
The following tables set forth our results of operations for the three months ended September 30, 2025 and 2024.
|
|
Three Months Ended September 30, |
|
|
Change Amount |
|
||||||
|
|
2025 |
|
|
2024 |
|
|
|
|
|||
|
|
(unaudited, in thousands) |
|
|
|
|
||||||
Operating expenses: |
|
|
|
|
|
|
|
|
|
|||
Research and development |
|
$ |
2,789 |
|
|
$ |
1,213 |
|
|
$ |
1,576 |
|
General, administrative and other |
|
|
2,249 |
|
|
|
2,139 |
|
|
|
110 |
|
Total operating expenses |
|
|
5,038 |
|
|
|
3,352 |
|
|
|
1,686 |
|
Loss from operations |
|
|
(5,038 |
) |
|
|
(3,352 |
) |
|
|
(1,686 |
) |
Other income/(expense) |
|
|
|
|
|
|
|
|
|
|||
Change in fair value of warrant liability |
|
|
— |
|
|
|
1,927 |
|
|
|
(1,927 |
) |
Change in fair value of forward contract liability |
|
|
— |
|
|
|
849 |
|
|
|
(849 |
) |
Change in fair value of SEPA put option liability |
|
|
33 |
|
|
|
— |
|
|
|
33 |
|
Change in fair value of convertible debt |
|
|
(846 |
) |
|
|
— |
|
|
|
(846 |
) |
Other income/(expense) |
|
|
— |
|
|
|
2 |
|
|
|
(2 |
) |
Interest income |
|
|
73 |
|
|
|
79 |
|
|
|
(6 |
) |
Interest expense |
|
|
— |
|
|
|
(5 |
) |
|
|
5 |
|
Total other income/(expense) |
|
|
(740 |
) |
|
|
2,852 |
|
|
|
(3,592 |
) |
Net loss |
|
$ |
(5,778 |
) |
|
$ |
(500 |
) |
|
$ |
(5,278 |
) |
Research and Development Expenses
Research and development expenses were $2.8 million and $1.2 million for the three months ended September 30, 2025 and 2024, respectively. The increase of $1.6 million was primarily due to:
Research and development expenses are not tracked by product candidate.
General, Administrative and Other Expenses
General, administrative and other expenses were $2.2 million and $2.1 million for the three months ended September 30, 2025 and 2024, respectively. The increase of $0.1 million was primarily due to:
Change in fair value of warrant liability
Change in fair value of warrant liability was $0 and a gain of $1.9 million for the three months ended September 30, 2025 and 2024, respectively. The liability instrument to investors under the GEM SPA was comprised of the contingent warrant liability and contingent put option.
Change in fair value of forward contract liability
21
Change in fair value of forward contract liability was $0 and $0.8 million for the three months ended September 30, 2025 and 2024, respectively. A forward contract liability to sell shares to the investor at 90% of the average daily closing price per share over the Draw Down Pricing Period is recorded each time we issue a Draw Down Notice to GEM under the Share Purchase Agreement. The forward contract liability is remeasured at the end of each quarter, if open, and again upon receipt of the Closing Notice from the investor. The forward contract liability is eliminated upon receipt of the Closing Notice and funds from the investor.
Change in fair value of SEPA put option liability
On December 20, 2024, we entered into a Standby Equity Purchase Agreement (the “SEPA”) with a certain investor. Pursuant to the SEPA, and subject to certain conditions, we have the right, from time to time, until December 20, 2026, to require the investor to purchase up to $10.0 million of shares of Common Stock by delivering written notice to the investor. The SEPA was accounted for as a liability under ASC 815 because it includes an embedded put option and an embedded forward option. The SEPA put option liability was recognized at inception, and its fair value was estimated at $0.4 million and $0.5 million at September 30, 2025 and December 31, 2024, respectively. The change in fair value of the SEPA put option liability was a gain of $0.0 million during the three months ended September 30, 2025 and resulted primarily from changes in stock price and other assumptions used in the valuation model.
Change in fair value of convertible debt
We received advances in the form of convertible notes pursuant to the SEPA in December 2024 and June 2025 and elected to account for the short-term convertible notes under the fair value option. Under the fair value option, all costs associated with raising the funds were expensed immediately. The convertible notes were adjusted to their fair values at September 30, 2025 with a $0.8 million loss resulting from the increase in fair value.
Gain/(loss) on issuance of common stock in exchange for convertible debt, net
The investor converted $3.9 million of convertible debt into shares of Common Stock during the three months ended September 30, 2025. We recognized an approximate $0.4 million net loss on these conversions, which results from the difference between the quoted market price per share used to record the issuance of Common Stock and the conversion price per share.
Other income/(expense)
There is no other expense for the three months ended September 30, 2025 and $2,000 in other income for the three months ended September 30, 2024.
Interest income
Interest income was $0.1 million and $0.1 million for the three months ended September 30, 2025 and 2024, respectively. Interest income is comprised of interest income and unrealized gain/losses on cash equivalents.
Interest expense
Interest expense was $0 and $5,000 for the three months ended September 30, 2025 and 2024, respectively.
Income taxes
The effective income tax rate was 0.0% for all periods. Currently, we have recorded a full valuation allowance against our net deferred tax assets.
Comparison of Nine Months Ended September 30, 2025 and 2024
The following tables set forth our results of operations for the nine months ended September 30, 2025 and 2024.
22
|
|
Nine Months Ended September 30, |
|
|
Change Amount |
|
||||||
|
|
2025 |
|
|
2024 |
|
|
|
|
|||
|
|
(unaudited, in thousands) |
|
|
|
|
||||||
Operating expenses: |
|
|
|
|
|
|
|
|
|
|||
Research and development |
|
$ |
6,610 |
|
|
$ |
3,148 |
|
|
$ |
3,462 |
|
General, administrative and other |
|
|
7,449 |
|
|
|
6,877 |
|
|
|
572 |
|
Total operating expenses |
|
|
14,059 |
|
|
|
10,025 |
|
|
|
4,034 |
|
Loss from operations |
|
|
(14,059 |
) |
|
|
(10,025 |
) |
|
|
(4,034 |
) |
Other income/(expense) |
|
|
|
|
|
|
|
|
|
|||
Change in fair value of warrant liability |
|
|
— |
|
|
|
4,349 |
|
|
|
(4,349 |
) |
Change in fair value of forward contract liability |
|
|
— |
|
|
|
(650 |
) |
|
|
650 |
|
Change in fair value of SEPA put option liability |
|
|
23 |
|
|
|
— |
|
|
|
23 |
|
Change in fair value of convertible debt |
|
|
(963 |
) |
|
|
— |
|
|
|
(963 |
) |
Commitment fee expenses |
|
|
— |
|
|
|
(1,941 |
) |
|
|
1,941 |
|
Other income/(expense) |
|
|
(625 |
) |
|
|
31 |
|
|
|
(656 |
) |
Interest income |
|
|
222 |
|
|
|
188 |
|
|
|
34 |
|
Interest expense |
|
|
— |
|
|
|
(14 |
) |
|
|
14 |
|
Total other income/(expense) |
|
|
(1,343 |
) |
|
|
1,963 |
|
|
|
(3,306 |
) |
Net loss |
|
$ |
(15,402 |
) |
|
$ |
(8,062 |
) |
|
$ |
(7,340 |
) |
Research and Development Expenses
Research and development expenses were $6.6 million and $3.1 million for the nine months ended September 30, 2025 and 2024, respectively. The increase of $3.5 million was primarily due to:
Research and development expenses are not tracked by product candidate.
General, Administrative and Other Expenses
General, administrative and other expenses were $7.4 million and $6.9 million for the nine months ended September 30, 2025 and 2024, respectively. The increase of $0.6 million was primarily due to:
Change in fair value of warrant liability
Change in fair value of warrant liability was $0 and $4.3 million for the nine months ended September 30, 2025 and 2024, respectively. The liability instrument to investors under the GEM SPA was comprised of the contingent warrant liability and contingent put option.
Change in fair value of forward contract liability
Change in fair value of forward contract liability was $0 and $0.7 million for the nine months ended September 30, 2025 and 2024, respectively. We issued a Draw Down Notice to GEM under the Share Purchase Agreement on June 27, 2024, which created the forward contract liability to sell shares to the investor at 90% of the average daily closing price per share over the Draw Down Pricing Period. The $0.7 million loss during the nine months ended September 30, 2024 is based upon the estimated fair value of the forward contract liability for the Draw Down Notice issued, as remeasured at September 30, 2024, and was marked to market upon receipt of the Closing Notice from the investor.
Change in fair value of SEPA put option liability
23
The change in fair value of the SEPA put option liability was a loss of $0.0 million during the nine months ended September 30, 2025 and resulted primarily from changes in stock price and other assumptions used in the valuation model.
Change in fair value of convertible debt
We received advances in the form of convertible notes pursuant to the SEPA in December 2024 and June 2025 and elected to account for the short-term convertible notes under the fair value option. Under the fair value option, all costs associated with raising the funds were expensed immediately. The convertible notes were adjusted to their fair values at September 30, 2025 with a $1.0 million loss resulting from the increase in fair value.
Gain/(loss) on issuance of common stock in exchange for convertible debt, net
The investor converted $9.7 million of convertible debt into shares of Common Stock during the nine months ended September 30, 2025. We recognized an approximate $0.9 million net loss on these conversions, which results from the difference between the quoted market price per share used to record the issuance of Common Stock and the conversion price per share.
Other income/(expense)
Other expense for the nine months ended September 30, 2025 consists of $0.6 million of non-cash original discount on convertible debt and $30,000 in interest income for the nine months ended September 30, 2024.
Commitment fee expense
Commitment fee expense was $0 and $1.9 million for the nine months ended September 30, 2025 and 2024, respectively. A $2.0 million commitment fee pursuant to the GEM SPA became payable to GEM upon completion of the Direct Listing in January 2024. The commitment fee was payable to GEM as drawdown notices are issued, with any remaining balance payable one year after public listing. We sold $3.0 million of Common Stock to GEM under the GEM SPA during the nine months ended September 30, 2024, which made $0.1 million of the commitment fee payable immediately. This $0.1 million portion of the commitment fee was netted against the proceeds received in additional paid-in capital. The remaining $1.9 million was expensed immediately because we were planning to raise funds through other sources and had no plans to issue further Draw Down Notices to GEM prior to the one-year anniversary of our public listing when this remaining amount would have been due.
Interest income
Interest income was $0.2 million for both the nine months ended September 30, 2025 and 2024. Interest income is comprised of interest income and unrealized gain/losses on cash equivalents.
Interest expense
Interest expense was $0 and $0 for the nine months ended September 30, 2025 and 2024, respectively.
Income taxes
The effective income tax rate was 0.0% for all periods. Currently, we have recorded a full valuation allowance against our net deferred tax assets.
Liquidity and Capital Resources
Overview
Through September 30, 2025, we have financed our operations primarily with investment from FibroGenesis, proceeds from borrowings under our convertible loan agreements, proceeds from the issuance of preferred stock, and proceeds from the sale of Common Stock through the GEM SPA and the SEPA. From inception through September 30, 2025, we have received aggregate proceeds of $15.0 million from sales of our convertible notes, $18.6 million from the sales of preferred stock, $10.4 million from the issuance of Common Stock and $13.1 million from the issuance of additional convertible promissory notes under the SEPA. As of September 30, 2025, we had cash and cash equivalents of $4.9 million and an accumulated deficit of $50.9 million. As of September 30, 2025, we had $5.3 million principal balance of outstanding debt with a fair value of $4.6 million.
Cash Flows
The following table sets forth a summary of our cash flows for the nine months ended September 30, 2025 and 2024.
|
|
Nine Months Ended September 30, |
|
|||||
|
|
2025 |
|
|
2024 |
|
||
|
|
(in thousands) |
|
|||||
Net cash used in operating activities |
|
$ |
(13,231 |
) |
|
$ |
(8,828 |
) |
Net cash used in investing activities |
|
|
(262 |
) |
|
|
(85 |
) |
Net cash provided by financing activities |
|
|
4,375 |
|
|
|
7,577 |
|
|
|
|
|
|
|
|
||
Net decrease in cash and cash equivalents |
|
$ |
(9,118 |
) |
|
$ |
(1,336 |
) |
Cash Flows from Operating Activities
24
Net cash used in operating activities was $13.2 million and $8.8 million for the nine months ended September 30, 2025 and 2024, respectively, and consisted primarily of net losses of $15.4 million and $8.1 million, respectively. Noncash expenses consisting of change in fair value of convertible debt of $1.0 million, stock-based compensation expense of $2.0 million, and amortization of operating lease right-of-use asset of $0.4 million partially offset the net loss, while a decrease in prepaid expenses of $0.1 million, a decrease in accounts payable and accrued expenses of $1.4 million, and a decrease in operating lease liability of $0.4 million added to the cash used in operations in the nine months ended September 30, 2025. Noncash losses on stock-based compensation expense of $1.7 million and change in fair value of forward contract liability of $0.7 million, and amortization of operating lease right-of-use asset of $0.3 million, and change in commitment fee payable of $1.9 million partially offset the net loss, while noncash gain on change in fair value of liability instrument of $4.3 million, an increase in prepaid expenses of $0.3 million, a decrease in accounts payable and accrued expenses of $0.3 million, a decrease in payable to Parent of $0.1 million, and a decrease in operating lease liability of $0.3 million added to the cash used in operations in the nine months ended September 30, 2024.
Cash Flows from Investing Activities
Net cash used in investing activities was $0.3 million and $0.1 million for the nine months ended September 30, 2025 and 2024, respectively, and consisted primarily of laboratory equipment purchases.
Cash Flows from Financing Activities
Net cash provided by financing activities was $4.4 million and $7.6 million for the nine months ended September 30, 2025 and 2024, respectively. During the nine months ended September 30, 2025, the Company issued short-term convertible debt with a principal balance of $5.0 million net cash of $4.4 million. During the nine months ended September 30, 2024, we entered into a $0.6 million short-term borrowing agreement to finance the D&O insurance policy premiums and repaid $0.5 million of the principal borrowed, and we raised $7.5 million of net proceeds from the sale of common stock under the GEM SPA.
Funding Requirements
We have incurred operating losses since our formation and expect such losses to continue in the future as we build infrastructure, develop intellectual property and conduct research and development activities. Moreover, we have incurred, and expect to continue to incur, additional costs associated with operating as a public company. We do not have any products approved for sale, and we have never generated any revenue from product sales. We have primarily relied on a combination of angel investors, private debt placements, convertible debt issuances, and sales of equity to fund our operations. As of September 30, 2025, we had an accumulated deficit of $50.9 million and cash and cash equivalents of $4.9 million. We do not expect to generate any meaningful revenue unless and until we obtain regulatory approval of and commercialize any of our current or future product candidates and we do not know when, or if, that will occur. Unless and until such time that revenue and net income are generated, we will need to continue to raise additional capital. These factors raise substantial doubt about our ability to continue as a going concern for one year from the issuance of the financial statements included in this Quarterly Report. The financial statements have been prepared as though we will continue as a going concern, which contemplates the realization of assets and satisfaction of liabilities in the normal course of business, and do not include any adjustments that might be necessary if we are unable to continue as a going concern.
Our ability to continue as a going concern is dependent on our ability to raise additional capital. We believe we will be able to obtain additional capital through equity financings or other arrangements to fund operations; however, there can be no assurance that such additional financing, if available, can be obtained on acceptable terms. If we are unable to obtain adequate financing when needed, we may have to delay, reduce the scope of, or suspend one or more of our preclinical studies, clinical trials, research and development programs or commercialization efforts. During the nine months ended September 30, 2025, we have implemented measures to reduce operating expenses including delaying certain research and development project spend while prioritizing near term pipeline projects, limiting finance, legal and administrative costs, and pursuing options to limit spend on office space. We may seek to raise any necessary additional capital through a combination of public or private equity offerings, debt financings, collaborations, and other licensing arrangements. If we raise additional capital through debt financing, we may be subject to covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures, or declaring dividends. If we raise additional capital through marketing and distribution arrangements or other collaborations, strategic alliances, or licensing arrangements with third parties, we may have to relinquish certain valuable rights to our product candidates, technologies, future revenue streams or research programs or grant licenses on terms that may not be favorable to us.
Our future funding requirements will depend on many factors, including, but not limited to:
25
We are subject to all the risks typically related to the development of new product candidates, and we may encounter unforeseen expenses, difficulties, complications, delays, and other unknown factors that may adversely affect our business. Further, our operating plan may change, and we may need additional funds to meet operational needs and capital requirements for clinical trials and other research and development expenditures.
Contractual Obligations and Commitments
We have material cash requirements and other contractual obligations related to our office and lab rent (as described in Note 9, “Leases, Commitments and Contingencies” to the financial statements in this Quarterly Report).
Critical Accounting Estimates
Our management’s discussion and analysis of our financial condition and results of operations is based on our financial statements, which have been prepared in accordance with GAAP. The preparation of these financial statements requires us to make estimates, judgments and assumptions that affect the reported amounts of assets and liabilities, disclosure of contingent assets and liabilities as of the dates of the balance sheets and the reported amounts of expenses during the reporting periods. In accordance with GAAP, we evaluate our estimates and judgments on an ongoing basis. We base our estimates on historical experience and on various other factors that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions.
We define our critical accounting estimates as those under GAAP that require us to make subjective estimates and judgments about matters that are uncertain and are likely to have a material impact on our financial condition and results of operations, as well as the specific manner in which we apply those principles. For a description of our critical accounting policies and estimates, please see the disclosures in Part II, Item 7 of the Annual Report.
Item 3. Quantitative and Qualitative Disclosures About Market Risk
We are a smaller reporting company as defined by Rule 12b-2 of the Securities Exchange Act of 1934, as amended, or the Exchange Act, and are not required to provide the information specified under this item.
Item 4. Controls and Procedures
We maintain disclosure controls and procedures (as defined in Exchange Act Rule 13a–15(e) and 15d-15(e)) that are designed to ensure that information required to be disclosed in our reports under the Exchange Act, and the rules and regulations thereunder, is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms and that such information is accumulated and communicated to our management, including our chief executive officer and chief financial officer, to allow for timely decisions regarding required disclosure. In designing and evaluating the disclosure controls and procedures, management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving the desired control objectives, and management is required to apply its judgment in evaluating the cost-benefit relationship of possible controls and procedures.
Evaluation of Disclosure Controls and Procedures
We have carried out an evaluation, under the supervision, and with the participation, of management, including our chief executive officer and chief financial officer, of our disclosure controls and procedures (as defined in Rule 13a-15(e)) of the Exchange Act) as of the end of the period covered by this Quarterly Report on Form 10–Q. During the preparation of our financial statements for the nine months ended September 30, 2025, our management identified a material weakness in our internal control over financial reporting due to a lack of segregation of duties. A material weakness is defined as a deficiency, or a 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.
Specifically, our management identified a material weakness in our internal controls within the financial reporting function that resulted from an ineffective design and implementation of controls over proper segregation of duties for the period of time covered by our financial statements prior to our then-Chief Financial Officer joining us in June 2022 when all financial functions were handled by a single individual, and afterward, through September 30, 2025, due to a limited number of individuals. Based upon such evaluation, and due to the material weakness identified, our principal executive officer and principal financial and accounting officer have concluded that our disclosure controls and procedures were not effective.
Remediation Plan for Material Weakness
26
With the addition of a chief financial officer and the changes made to our accounting and financial reporting processes and internal controls during the last half of fiscal year 2022 and through September 30, 2025, we have strengthened our internal controls and will continue to add staff, evaluate segregation of duties, and implement initiatives to improve our internal controls over financial reporting as we grow and funding allows.
Changes in Internal Control over Financial Reporting
There has been no change in the Company’s internal control over financial reporting as defined in Rules 13a-15(f) and 15d-15(f) that occurred during the three months ended September 30, 2025, that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
Limitations on the Effectiveness of Controls
A control system, no matter how well conceived and operated, can provide only reasonable, not absolute, assurance that the objectives of the control system are met. Because of inherent limitations in all control systems, no evaluation of controls can provide absolute assurance that all control issues, if any, within an organization have been detected. Accordingly, our disclosure controls and procedures and our internal control over financial reporting are designed to provide reasonable, not absolute, assurance that the objectives of the control system are met. We continue to implement, improve, and refine our disclosure controls and procedures and our internal control over financial reporting.
27
PART II — OTHER INFORMATION
Item 1. Legal Proceedings
From time to time, we may be involved in legal proceedings relating to intellectual property, commercial, employment and other matters arising in the ordinary course of business. Such matters are subject to uncertainty and there can be no assurance that such legal proceedings will not have a material adverse effect on our business, results of operations, financial position, or cash flows. We are not party to any legal proceedings at this time.
Item 1A. Risk Factors
Our business is subject to risks, uncertainties, and events that, if they occur, could adversely affect our financial condition and results of operations and the trading price of our securities. Except as set forth below, there have been no material changes from the risk factors previously described in “Part I, Item 1A. Risk Factors” of the Annual Report.
Risks Related to Our Financial Condition and Capital Requirements
There is substantial doubt about our ability to continue as a going concern.
We have incurred recurring operating losses and negative cash flows from operating activities since inception and expect to continue incurring operating losses and negative cash flows in the future. In connection with the preparation of our Quarterly Report, our management concluded that there is substantial doubt as to whether we can continue as a going concern for the twelve months following the issuance of the Quarterly Report. Our ability to continue as a going concern is dependent upon raising capital to maintain current operations and continue research and development efforts. We plan to raise additional capital to fund our operations through public or private equity offerings, debt financings, and/or potential collaborations and license arrangements or other sources. There is no assurance, however, that any additional financing or any revenue-generating collaboration will be available when needed or that we will be able to obtain financing or enter into a collaboration on terms acceptable to us.
These factors raise substantial doubt about our ability to continue as a going concern. Substantial doubt about our ability to continue as a going concern may materially and adversely affect the price per share of our Common Stock, and it may be more difficult for us to obtain financing. If existing or potential collaborators decline to do business with us or potential investors decline to participate in any future financings due to such concerns, our ability to increase our cash position may be limited. The perception that we may not be able to continue as a going concern may cause others to choose not to deal with us due to concerns about our ability to meet our contractual obligations. We have prepared our condensed consolidated financial statements on a going concern basis, which contemplates the realization of assets and the satisfaction of liabilities and commitments in the normal course of business. Our financial statements do not include any adjustments that might be necessary if we are unable to continue as a going concern. During the nine months ended September 30, 2025, we have implemented measures to reduce operating expenses including delaying certain research and development project spend while prioritizing near term pipeline projects, limiting finance, legal and administrative costs, and pursuing options to limit spend on office space. If we are unable to continue as a going concern, we will be forced to further delay, reduce, or discontinue our research and development programs or consider other various strategic alternatives and you could lose all or part of your investment in us.
Risks Related to Manufacturing
Manufacturing cell therapy products is complex and subject to both human and systemic risks. Our third-party manufacturers or we may encounter difficulties in production and sourcing and may be subject to variations and supply constraints of critical components. If we or any of our third-party manufacturers encounter such difficulties, our ability to supply our product candidates for clinical trials or our products for patients, if approved, could be delayed or prevented.
The manufacture of biologic cell therapy product candidates, and products, if approved, is complex and requires significant expertise and capital investment, including developing advanced manufacturing techniques and process controls. Manufacturers of biologic products often encounter difficulties in production and sourcing, particularly in scaling up or out, validating the production process, and assuring high reliability of the manufacturing processes (including the absence of contamination), in light of variations and supply constraints of critical components. These problems include logistics and shipping, difficulties with production costs and yields, quality control, including consistency, stability, purity, and efficacy of the product, product testing, operator error, and availability of qualified personnel, as well as compliance with strictly enforced federal, state, and foreign regulations. For example, timelines for our planned twelve-week Phase 1/2 clinical trial utilizing CYWC628 for treatment of diabetic foot ulcers in Australia have been extended as we work with our CDMO to resolve process issues with the manufacturing training runs and increase the number of aseptic process simulation runs needed to confirm sterility of the manufacturing process before we begin the manufacture of CYWC628 for the clinical trial. Furthermore, if contaminants are discovered in our supply of our product candidates or in the manufacturing facilities, such manufacturing facilities may need to be closed for an extended period of time to investigate and remedy the contamination. We cannot assure you that any stability, purity, and efficacy failures, deficiencies, or other issues relating to manufacturing our product candidates will not occur in the future.
Additionally, our product candidates are derived from cells collected from humans. Such cells may vary in type and quality as the donors may vary in age, medical history, and many other factors. We have strict specifications for donor cell material and our product candidates. The donor cell material variability may exceed our manufacturing process capability or deviate from the specified ranges and result in failure in the production of the cell therapy product, lower quality batches, or even require adjustments to the specifications approved by authorities. The donor cell material may also be variable in factors that we currently may not be able to detect with the analytical methods used or may not know how to measure. We may also discover failures with the material after production. As a result, we may not be able to deliver the quality and consistency of our cell therapy products that we need or may need to re-collect cell material which can increase costs and/or cause delay, result in recalls, adversely impact patient outcomes and otherwise harm our clinical trials, reputation, business, and prospects.
28
We may fail to manage the logistics of collecting and shipping patient material to the manufacturing site, shipping the product candidate back to the relevant parties, and experiencing delays or shortages of certain clinical or commercial-grade supplies and components. Logistical and shipment delays and problems caused by us, our vendors, or other factors not in our control, including business interruptions, global supply chain issues, and weather, could prevent or delay the delivery of product candidates to patients. Additionally, we have to maintain a complex chain of identity and chain of custody with respect to donor material as it moves to the manufacturing facility, through the manufacturing processes, and ultimately to a patient. Failure to maintain a chain of identity and chain of custody could result in patient death, loss of product, or regulatory action.
Our failure, or the failure of our third-party manufacturers, to comply with applicable regulations could result in sanctions being imposed on us, including clinical holds, fines, injunctions, civil penalties, delays, suspension or withdrawal of approvals, seizures or voluntary recalls of product candidates, operating restrictions, and criminal prosecutions, any of which could significantly affect supplies of our product candidates. The facilities used by our contract manufacturers to manufacture our product candidates must be evaluated by the FDA. We do not control the manufacturing process of, and are completely dependent on, our contract manufacturing partners for compliance with cGMPs. If our contract manufacturers cannot successfully manufacture material that conforms to our specifications and the strict regulatory requirements of the FDA, the EMA, or other comparable regulatory authorities, we may not be able to secure and/or maintain regulatory approval for our product candidates manufactured at these facilities. In addition, we have no control over the ability of our contract manufacturers to maintain adequate quality control, quality assurance and qualified personnel. If the FDA finds deficiencies or a comparable foreign regulatory authority does not approve these facilities for the manufacture of our product candidates or if it withdraws any such approval in the future, we may need to find alternative manufacturing facilities, which would significantly impact our ability to develop, obtain regulatory approval for or market our product candidates, if approved. Contract manufacturers may face manufacturing or quality control problems causing drug substance production and shipment delays or a situation where the contractor may not be able to maintain compliance with the applicable cGMP requirements. Any failure to comply with cGMP requirements or other FDA, EMA and comparable foreign regulatory requirements could adversely affect our clinical research activities and our ability to develop our product candidates and market our products, if approved.
The production of our cell banks and product candidates by a contract development manufacturing organization may fail and result in delays, additional costs, or technical failure.
We have contracted with CDMOs for the production of our master cell banks and working cell banks for our fibroblast cell-based product candidates to enable clinical trials. If the CDMO is unable to produce our master cell banks, working cell banks and our fibroblast cell-based product candidates to enable clinical trials, we may encounter delays, additional costs, or technical failure of one or more of our product candidates. For example, timelines for our planned twelve-week Phase 1/2 clinical trial utilizing CYWC628 for treatment of diabetic foot ulcers in Australia have been extended as we work with our CDMO to resolve process issues with the manufacturing training run and increase the number of aseptic process simulation runs needed to confirm sterility of the manufacturing process before we begin the manufacture of CYWC628 for the clinical trial.
Our reliance on third parties reduces our control over our product candidate development activities but does not relieve us of our responsibility to ensure compliance with all required legal, regulatory and industry standards. For example, the FDA and other regulatory authorities require that our product candidates and any products that we may eventually commercialize be manufactured according to cGMP requirements. Any failure by our third-party manufacturers to comply with cGMP or maintain a compliance status acceptable to the FDA or other regulatory authorities or failure to scale up manufacturing processes, including any failure to deliver sufficient quantities of product candidates in a timely manner, could lead to a delay in, or failure to obtain, regulatory approval of any of our product candidates.
If we were to need an alternate CDMO, we would incur added costs and delays in identifying and qualifying any such replacement. In addition, we expect to order drug product and services on a statement of work or purchase order basis and do not plan to enter into long-term dedicated capacity or minimum supply arrangements with any commercial manufacturer. We may not be able to timely secure needed supply arrangements on satisfactory terms, or at all. Our failure to secure these arrangements as needed could have a material adverse effect on our ability to complete the development of our product candidates or, to commercialize them, if approved. We may be unable to conclude agreements for commercial supply with third-party manufacturers or may be unable to do so on acceptable terms. There may be difficulties in scaling up to commercial quantities and formulation of our product candidates, and the costs of manufacturing could be prohibitive.
Changes in the methods of product candidate manufacturing or formulation may result in additional costs or delay.
As product candidates proceed through preclinical studies to late-stage clinical trials towards potential marketing approval and commercialization, it is common that various aspects of the development program, such as manufacturing methods, formulation, materials, and processes, are altered along the way in an effort to optimize processes and product characteristics. Such alterations can also occur due to changes in manufacturers. Such changes carry the risk that they will not achieve their intended objectives. Any such changes could cause our product candidates to perform differently and affect the results of planned clinical trials or other future clinical trials conducted with product candidates produced using the modified manufacturing methods, materials, and processes. Such changes may also require additional testing, FDA notification or FDA approval. This could delay the completion of clinical trials, require the conduct of bridging clinical trials or the repetition of one or more clinical trials beyond those we currently anticipate, increase clinical trial costs, delay approval of our product candidates and jeopardize our ability to commercialize our product candidates if approved. In addition, we may be required to make significant changes to our upstream and downstream processes across our pipeline, which could delay the development of future product candidates. For example, we encountered process issues with the manufacturing training run of CYWC628 and will need to increase the number of aseptic process simulation runs needed to confirm sterility of the manufacturing process before we begin the manufacture of CYWC628 for the clinical trial. These issues have caused us to extend the timelines for the initiation and completion of our planned twelve-week Phase 1/2 clinical trial utilizing CYWC628 for treatment of diabetic foot ulcers in Australia. If changes are needed to the manufacturing methods for CYWC628 as a result of these issues, the timing for the initiation and completion of our clinical trial in Australia may be further delayed.
We rely on third parties for our manufacturing process and may, in the future, depend on third-party manufacturers for our product candidates, and this increases the risk related to the timely and sufficient production of our product candidates.
29
We do not have complete control over all aspects of the manufacturing process of, and are dependent on, our contract manufacturing partners for compliance with cGMP regulations for manufacturing our cell therapy product candidates. Third-party manufacturers may be unable to comply with cGMP regulations or similar regulatory requirements outside the United States. If our contract manufacturers cannot successfully manufacture material that conforms to our specifications and the strict regulatory requirements of the FDA, the EMA, or other regulatory authorities, we will not be able to produce our product candidates. In addition, we do not have control over the ability of our contract manufacturers to maintain adequate quality control, quality assurance and qualified personnel. For example, we are currently working with our CDMO to resolve process issues with the manufacturing training runs of CYWC628 and to increase the number of aseptic process simulation runs needed to confirm sterility of the manufacturing process before we begin the manufacture of CYWC628 for our planned twelve-week Phase 1/2 clinical trial utilizing CYWC628 for treatment of diabetic foot ulcers in Australia. If these issues are not resolved, we will be unable to manufacture CYWC628 for our planned clinical trial in a timely manner. If the FDA, the EMA, or a comparable foreign regulatory authority does not approve these facilities for the manufacture of our product candidates or if it withdraws any such approval in the future, we may need to find alternative manufacturing facilities, which would significantly impact our ability to develop, obtain marketing approval for or market our product candidates, if approved. Our failure, or the failure of our third-party manufacturers, to comply with applicable regulations could result in sanctions being imposed on us, including fines, injunctions, civil penalties, delays, suspension or withdrawal of approvals, license revocation, seizures or recalls of product candidates, operating restrictions and criminal prosecutions, any of which could significantly and adversely affect supplies of our product candidates and harm our business and results of operations. Furthermore, the raw materials for our product candidates may be sourced, in some cases, from a single-source supplier. If we were to experience an unexpected loss of supply of any of our product candidates or any of our future product candidates for any reason, whether as a result of manufacturing, supply, or storage issues or otherwise, we could experience delays, disruptions, suspensions, or terminations of, or be required to restart or repeat, any pending or ongoing clinical trials.
We currently rely on third-party manufacturers to produce our product candidates. In the event that we or any of our third-party manufacturers fail to comply with such requirements or to perform with certain requirements in relation to quality, timing, or otherwise, or if our supply of components or other materials becomes limited or interrupted for other reasons, we may be forced to enter into an agreement with another third party, which we may not be able to do on commercially reasonable terms, if at all. In particular, any replacement of our third-party manufacturers could require significant effort and expertise because there may be a limited number of qualified replacements. In some cases, the technical skills or technology required to manufacture our product candidates may be unique or proprietary to us or the third-party manufacturer. We may have difficulty transferring such skills or technology to another third party, and a feasible alternative may not exist. In addition, certain of our product candidates and our own proprietary methods have never been produced or implemented outside of our company. Therefore, we may experience delays in our development programs if we attempt to establish new third-party manufacturing arrangements for these product candidates or methods. These factors would increase our reliance on such manufacturers or require us to obtain a license from such manufacturers in order to have another third party manufacture our product candidates. If we are required to or voluntarily stop manufacturing our product candidates for any reason, we will be required to verify that the new manufacturer maintains facilities and procedures that comply with quality standards and with all applicable regulations and guidelines and that the product produced is equivalent to that produced in our facility. The delays associated with the verification of a new manufacturer and equivalent product could negatively affect our ability to develop product candidates in a timely manner or within budget.
Our or a third party’s failure to execute our manufacturing requirements, do so on commercially reasonable terms and timelines, and comply with cGMP requirements could adversely affect our business in a number of ways, including:
|
● |
inability to meet our product specifications and quality requirements consistently; |
|
● |
inability to initiate or continue clinical trials of our product candidates under development; |
|
● |
delays in submitting regulatory applications or receiving marketing approvals for our product candidates, if at all; |
|
● |
inability to commercialize any product candidates that receive marketing approval on a timely basis; |
|
● |
loss of the cooperation of future collaborators; |
|
● |
subjecting third-party manufacturing facilities or our manufacturing facilities to additional inspections by regulatory authorities; |
|
● |
requirements to cease development or to recall batches of our product candidates; and |
|
● |
in the event of approval to market and commercialize our product candidates, an inability to meet commercial demands for our product candidates or any future product candidates. |
Risks Related to Ownership of Our Common Stock
Failure to maintain compliance with the applicable Nasdaq continued listing requirements could result in our common stock being delisted, which could limit stockholders’ ability to trade our common stock.
As a listed company on Nasdaq, we are required to meet certain financial, public float, bid price and liquidity standards on an ongoing basis to continue the listing of our common stock. If we fail to meet these continued listing requirements, our common stock may be subject to delisting, which could materially impact the liquidity of our common stock making it more challenging to buy and sell shares of our common stock. On April 1, 2025, the listing of our common stock was moved from the Nasdaq Global Market to the Nasdaq Capital Market. We requested this move to allow us to satisfy less stringent financial, liquidity, and market capitalization requirements to continue the listing of our common stock. For example, the market value requirement of the Nasdaq Capital Market is $35 million versus $50 million for the Nasdaq Global Market and the stockholders’ equity requirement
30
for the Nasdaq Capital Market is $2.5 million versus $10 million for the Nasdaq Global Market. Following the transfer, we remain subject to the $1 minimum bid price requirement and continued listing requirements for the Nasdaq Capital Market, and no assurance can be given that we will be able to satisfy these requirements. If we fail to meet any of these requirements after the transfer, our securities may be delisted from Nasdaq.
On July 1, 2025, we received a notification letter from the Nasdaq Listing Qualifications Staff notifying us that the closing bid price of our shares of common stock was below the minimum closing bid price of $1.00 per share during the previous 30 consecutive trading days, or the Notice, as required for continued listing on the Nasdaq Capital Market under Nasdaq Listing Rule 5550(a)(2).
In accordance with Nasdaq Listing Rule 5810(c)(3)(A), we have been provided an initial period of 180 calendar days, or until December 29, 2025, to regain compliance with this requirement. To regain compliance, the closing bid price of our common stock must be $1.00 per share or more for a minimum of 10 consecutive business days at any time before December 29, 2025. If we do not regain compliance with Rule 5550(a)(2) by December 29, 2025, we may be eligible for an additional 180 calendar day compliance period. To qualify, we will be required to meet the continued listing requirement for market value of publicly held shares and all other initial listing standards for the Nasdaq Capital Market, except the bid price requirement, and will need to provide written notice to Nasdaq of our intention to cure the deficiency during the second compliance period. If it appears to the Staff that we will not be able to cure the deficiency, or if we are otherwise not eligible, Nasdaq will notify us that our securities will be subject to delisting. In the event of such notification, we may appeal the Staff’s determination to delist our securities, but there can be no assurance the Staff will grant our request for continued listing.
Additionally, on August 4, 2025, we received a notification letter from the Staff notifying us that we do not meet the requirement in Nasdaq Listing Rule 5550(b)(2) to maintain a minimum market value of listed securities, or MVLS, of $35.0 million that is required for continued listing on The Nasdaq Capital Market.
In accordance with Nasdaq Listing Rule 5810(c)(3)(C), we have a period of 180 calendar days, or until February 2, 2026, to regain compliance with this requirement. To regain compliance, our MVLS must close at $35.0 million or more for a minimum of 10 consecutive business days at any time before February 2, 2026. If we do not regain compliance with Rule 5550(b)(2) by February 2, 2026, Nasdaq will notify us that our securities are subject to delisting. In the event of such notification, we may appeal the Staff’s determination to delist our securities, but there can be no assurance the Staff will grant our request for continued listing.
We continue to actively monitor our performance with respect to the listing standards and will consider available options to resolve any deficiency and maintain compliance with the Nasdaq rules. There can be no assurance that we will be able to maintain compliance or, if we fall out of compliance, regain compliance with any deficiency, or if we implement an option that regains our compliance, maintain compliance thereafter. If we fail to regain compliance with the Nasdaq continued listing standards, our common stock will be subject to delisting from Nasdaq.
Without a Nasdaq market listing, stockholders may have a difficult time getting a quote for the sale or purchase of our common stock, the sale or purchase of our common stock would likely be made more difficult and the trading volume and liquidity of our common stock could decline. Delisting from Nasdaq could also result in negative publicity and could also make it more difficult for us to raise additional capital. The absence of such a listing may adversely affect the acceptance of our common stock as currency or the value accorded by other parties. Further, if we are delisted, we would lose federal pre-emption of state securities laws as it relates to our securities and thus also incur additional costs under state blue sky laws in connection with any sales of our securities. These requirements could severely limit the market liquidity of our common stock and the ability of our stockholders to sell our common stock in the secondary market. If our common stock is delisted by Nasdaq, our common stock may be eligible to trade on an over-the-counter quotation system, such as the OTCQB market, where an investor may find it more difficult to sell our common stock or obtain accurate quotations as to the market value of our common stock. We cannot assure you that our common stock, if delisted from Nasdaq, will be listed on another national securities exchange or quoted on an over-the counter quotation system. If our common stock is delisted, it may come within the definition of “penny stock” as defined in the Exchange Act and would be covered by Rule 15g-9 of the Exchange Act. Rule 15g-9 imposes additional sales practice requirements on broker-dealers who sell securities to persons other than established customers and accredited investors. For transactions covered by Rule 15g-9, the broker-dealer must make a special suitability determination for the purchaser and receive the purchaser’s written agreement to the transaction prior to the sale. Consequently, Rule 15g-9, if it were to become applicable, would affect the ability or willingness of broker-dealers to sell our securities, and accordingly would affect the ability of stockholders to sell their securities in the public market. These additional procedures could also limit our ability to raise additional capital in the future.
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds
The following sets forth information regarding all unregistered securities we sold during the nine months ended September 30, 2025. Unless stated otherwise, the sales of the securities listed below were deemed to be exempt from registration pursuant to Section 4(a)(2) of the Securities Act, as transactions by an issuer not involving a public offering.
On January 7, 2025, we satisfied the commitment fee due under the SEPA with YA II PN, LTD., or the Investor, by issuing 118,991 shares of our Common Stock to the Investor at a $2.1010 price per share.
Below is a summary of conversions during the nine months ended September 30, 2025 by the Investor of short-term convertible notes issued to the Investor under the SEPA:
31
Date |
|
Tranche |
|
Principal Amount |
|
|
Shares Issued |
|
|
Price Per Share |
|
|||
January 23, 2025 |
|
Second Note |
|
$ |
900,000 |
|
|
|
552,113 |
|
|
$ |
1.6301 |
|
January 27, 2025 |
|
Second Note |
|
$ |
500,000 |
|
|
|
317,238 |
|
|
$ |
1.5761 |
|
January 29, 2025 |
|
Second Note |
|
$ |
500,000 |
|
|
|
334,336 |
|
|
$ |
1.4955 |
|
February 7, 2025 |
|
Second Note |
|
$ |
1,100,000 |
|
|
|
732,941 |
|
|
$ |
1.5008 |
|
February 21, 2025 |
|
Second Note |
|
$ |
250,000 |
|
|
|
232,169 |
|
|
$ |
1.0768 |
|
March 4, 2025 |
|
Second Note |
|
$ |
350,000 |
|
|
|
361,794 |
|
|
$ |
0.9674 |
|
April 11, 2025 |
|
Second Note |
|
$ |
200,000 |
|
|
|
263,643 |
|
|
$ |
0.7586 |
|
April 15, 2025 |
|
Second Note |
|
$ |
200,000 |
|
|
|
263,643 |
|
|
$ |
0.7586 |
|
May 15, 2025 |
|
Second Note |
|
$ |
300,000 |
|
|
|
388,450 |
|
|
$ |
0.7723 |
|
June 2, 2025 |
|
Second Note |
|
$ |
100,000 |
|
|
|
147,579 |
|
|
$ |
0.6776 |
|
June 3, 2025 |
|
Second Note |
|
$ |
300,000 |
|
|
|
442,739 |
|
|
$ |
0.6776 |
|
June 20, 2025 |
|
Second Note |
|
$ |
100,000 |
|
|
|
144,216 |
|
|
$ |
0.6934 |
|
June 24, 2025 |
|
Second Note |
|
$ |
200,000 |
|
|
|
295,377 |
|
|
$ |
0.6771 |
|
June 26, 2026 |
|
Third Note |
|
$ |
300,000 |
|
|
|
443,066 |
|
|
$ |
0.6771 |
|
June 27, 2025 |
|
Third Note |
|
$ |
500,000 |
|
|
|
738,443 |
|
|
$ |
0.6771 |
|
July 15, 2025 |
|
Third Note |
|
$ |
300,000 |
|
|
|
533,428 |
|
|
$ |
0.5624 |
|
July 28, 2025 |
|
Third Note |
|
$ |
300,000 |
|
|
|
493,258 |
|
|
$ |
0.6082 |
|
August 1, 2025 |
|
Third Note |
|
$ |
600,000 |
|
|
|
1,035,911 |
|
|
$ |
0.5792 |
|
August 18, 2025 |
|
Third Note |
|
$ |
300,000 |
|
|
|
571,537 |
|
|
$ |
0.5249 |
|
August 25, 2025 |
|
Third Note |
|
$ |
300,000 |
|
|
|
544,959 |
|
|
$ |
0.5505 |
|
September 9, 2025 |
|
Third Note |
|
$ |
300,000 |
|
|
|
566,572 |
|
|
$ |
0.5295 |
|
September 16, 2025 |
|
Third Note |
|
$ |
300,000 |
|
|
|
597,133 |
|
|
$ |
0.5024 |
|
September 25, 2025 |
|
Third Note |
|
$ |
400,000 |
|
|
|
815,660 |
|
|
$ |
0.4904 |
|
September 30, 2025 |
|
Third Note |
|
$ |
1,100,000 |
|
|
|
2,243,065 |
|
|
$ |
0.4904 |
|
Item 3. Defaults Upon Senior Securities
None.
Item 4. Mine Safety Disclosures
Not applicable.
Item 5. Other Information
Director and Officer Trading Plans and Arrangements
None of our directors or “officers,” as defined in Rule 16a-1(f) under the Securities Exchange Act of 1934,
32
Item 6. Exhibits
|
|
|
|
Incorporation By Reference |
||||||
Exhibit Number |
|
Exhibit Description |
|
Form |
|
SEC File No. |
|
Exhibit |
|
Filing Date |
|
|
|
|
|
|
|
|
|
|
|
3.1 |
|
Amended and Restated Certificate of Incorporation of the Registrant |
|
8-K |
|
001-41934 |
|
3.1 |
|
August 28, 2024 |
|
|
|
|
|
|
|
|
|
|
|
3.2 |
|
Amendment to Amended and Restated Certificate of Incorporation of FibroBiologics, Inc. |
|
8-K |
|
001-41934 |
|
3.1 |
|
June 13, 2025 |
|
|
|
|
|
|
|
|
|
|
|
3.3 |
|
|
8-K |
|
001-41934 |
|
3.1 |
|
June 27, 2024 |
|
|
|
|
|
|
|
|
|
|
|
|
31.1 |
|
|
|
|
|
|
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|
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|
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|
|
|
|
|
31.2 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
32.1 |
|
|
|
|
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|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
101.INS |
|
Inline XBRL Instance Document- the instance document does not appear in the Interactive Data File because its XBRL tags are embedded within the Inline XBRL document. |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
101.SCH |
|
Inline XBRL Taxonomy Schema Document. |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
101.CAL |
|
Inline XBRL Taxonomy Calculation Linkbase Document. |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
101.DEF |
|
Inline XBRL Taxonomy Definition Linkbase Document. |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
101.LAB |
|
Inline XBRL Taxonomy Label Linkbase Document. |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
101.PRE |
|
Inline XBRL Taxonomy Presentation Linkbase Document. |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
104 |
|
Cover Page Interactive Data File (formatted as inline XBRL with applicable taxonomy extension information contained in Exhibits 101.INS, 101.SCH, 101.CAL, 101.DEF, 101.LAB, and 101.PRE). |
|
|
|
|
|
|
|
|
* The certifications attached as Exhibit 32.1 accompany this Quarterly Report on Form 10-Q pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, and shall not be deemed “filed” by the Registrant for purposes of Section 18 of the Securities Exchange Act of 1934, as amended.
33
SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
|
FIBROBIOLOGICS, INC. |
|
|
|
|
Date: October 31, 2025 |
By: |
/s/ Jason D. Davis |
|
|
Jason D. Davis Chief Financial Officer (Duly Authorized Officer and Principal Financial Officer) |
34
Exhibit 31.1
CERTIFICATION
I, Pete O’Heeron, certify that:
Date: October 31, 2025 |
|
|
|
|
/s/ Pete O’Heeron |
|
Pete O’Heeron |
|
Chief Executive Officer Principal Executive Officer |
Exhibit 31.2
CERTIFICATION
I, Jason D. Davis, certify that:
Date: October 31, 2025 |
|
|
|
|
/s/ Jason D. Davis |
|
Jason D. Davis |
|
Chief Financial Officer Principal Financial Officer |
Exhibit 32.1
STATEMENT PURSUANT TO 18 U.S.C. SECTION 1350
With reference to the Quarterly Report of FibroBiologics, Inc. (the “Company”), on Form 10-Q for the period ended September 30, 2025, as filed with the Securities and Exchange Commission on the date hereof (the “Report”), I, Pete O’Heeron, Chief Executive Officer of the Company, and Jason D. Davis, Chief Financial Officer of the Company, certify, pursuant to 18 U.S.C. § 1350, as adopted pursuant to § 906 of the Sarbanes-Oxley Act of 2002, that to my knowledge:
1) 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.
/s/ Pete O’Heeron |
Pete O’Heeron |
Chief Executive Officer |
|
/s/ Jason D. Davis |
Jason D. Davis |
Chief Financial Officer |
|
Date: October 31, 2025 |