ADDED
As of March 20, 2026, there were 10,895,725 shares of registrant s common stock outstanding, excluding 150,000 non-voting common stock held in escrow.
If we are unable to raise capital when needed, or if at all, we will be forced to delay, reduce or eliminate some of our product development programs or commercialization efforts , or cease our operations altogether.
Sponsor means First Light Acquisition Group, LLC, a Delaware series limited liability company.
3 SUMMARY OF RISK FACTORS The following is a summary of the principal factors that make an investment in our common stock speculative or risky.
This summary does not address every aspect of our risk factors, all of the risks that we face, or other factors not presently known to us or that we currently believe are immaterial.
As a result, the below summary risks do not contain all of the information that may be important to you, and you should read the summary risks together with the more detailed and complete discussion of risks set forth under the heading Risk Factors in Part I, Item 1A of this annual report, as well as elsewhere in this Annual Report and our other filings with the U.S.
Securities and Exchange Commission (SEC), before making investment decisions regarding our common stock.
Additional risks, beyond those summarized below or discussed elsewhere in this Annual Report, may apply to our activities or operations as currently conducted or as we may conduct them in the future or in the markets in which we operate or may in the future operate.
Consistent with the foregoing, we are exposed to a variety of risks, including risks associated with the following: Risks Related to Our Business, Financial Position and Capital Requirements We are a biotechnology company with a limited operating history and have not generated any revenue to date from product sales.
We have insufficient cash to continue our operations for the next 12 months and our continued operations are dependent on us raising capital and these conditions give rise to substantial doubt over the Company s ability to continue as a going concern.
REMOVED
As of March 24, 2025, there were 28,467,580 shares of registrant s common stock outstanding, excluding 1,800,000 non-voting common stock held in escrow.
If we are unable to raise capital when needed, or if at all, we will be forced to delay, reduce or eliminate some of our product development programs or commercialization efforts.
Significant Calidi Holder means Allan Camaisa and/or Scott Leftwich; and Sponsor means First Light Acquisition Group, LLC, a Delaware series limited liability company.
PART I ITEM 1 BUSINESS Overview We are a clinical stage immuno-oncology company that is developing proprietary allogeneic stem cell-based and enveloped virus platforms to potentiate and deliver oncolytic viruses (vaccinia virus and adenovirus) and, potentially, other molecules to cancer patients.
We are currently developing two proprietary stem cell-based platforms and one enveloped vaccinia virus platform designed to protect the oncolytic virus, whether natural or engineered, from neutralization by the patient s immune defenses, allowing for greater infection of the tumor cells and leading to a potential improvement in the antitumor activity of oncolytic viruses over traditional naked oncolytic virus therapies.
A naked virus means the virus is unprotected from the patient s immune defenses it has no relevance to engineering of the virus.
Similarly, engineered (modified virus) can be naked or protected.
Our Product candidates using allogeneic stem cells (stem cells derived from humans other than the patient) or enveloped virotherapies are being developed in order to: Protect oncolytic viruses from neutralizing antibodies and complement inactivation and innate immune cell inactivation; Enhance oncolytic viral amplification inside the allogeneic cells; and Modify the tumor microenvironment (TME) to allow improvements in cell targeting and viral amplification at the tumor site.
We believe our allogeneic stem cell product candidates have competitive advantages over other product candidates using autologous stem cells (stem cells derived only from the individual patient) including the following: Scale and patient compliance: Our allogeneic stem cell product candidates could be used to treat many patients upon FDA approval.
In contrast, the adipose tissue-derived autologous stem cell product candidates, if approved by the FDA, must be prepared and used the same day and only in a single patient.