What Changed
Risk factors · Mar 28, 2025 → Mar 26, 202613 added · 10 removed between the two most recent 10-Ks. The risks a company starts — or stops — disclosing are often the story.
Newly disclosed
- Implementation of our plans and our ability to continue as a going concern will depend upon our ability to develop our prescription drug candidates and prescription drug formulation candidates, and to raise additional capital.
- Management believes that we may have access to capital resources through possible public or private equity offerings, including the 2025 Financing, exchange offers, debt financings, corporate collaborations, or other means.
- There was no restricted cash associated with the grant received from the State of Tennessee as of December 31, 2025 due to the completion of the grant award program during 2025.
- Cash balances as of December 31, 2024 included $182,284 of restricted cash associated with a grant received from the State of Tennessee.
- The Company’s working capital deficit was $6,329,503 and $5,998,712 as of December 31, 2025 and 2024, respectively.
- Moreover, we or the FDA may suspend our clinical trials at any time if it appears we are exposing participants to unacceptable health risks or if the FDA finds deficiencies in our submissions or the conduct of these trials.
- We currently intend to retain all of our future earnings, if any, for use in our business and therefore do not anticipate paying any cash dividends on our common stock in the foreseeable future.
- Accordingly, our technologies may be rendered obsolete by advances in existing technologies or the development of different technologies by one or more of our current or future competitors.
- We also expect to experience negative operating cash flow for the foreseeable future as we fund our operating losses and any future capital expenditures.
- International regulatory approval processes generally include all of the risks associated with the FDA approval procedures described above.
- Many companies are also developing novel therapies to treat cancer and dermatological conditions and, in this regard, are our competitors.
- The Company’s cash balance was $251,291 at December 31, 2025.
No longer disclosed
- Implementation of our plans and our ability to continue as a going concern will depend upon our ability to develop our prescription drug candidates and prescription drug formulation candidates, and to raise additional capital. 13 Management believes that we may have access to capital resources through possible public or private equity offerings, including the 2025 Financing, exchange offers, debt financings, corporate collaborations, or other means.
- The Company’s cash balance was $489,726 at December 31, 2024, which includes $182,284 of restricted cash resulting from a grant received from the State of Tennessee.
- Events which may result in delays or unsuccessful completion of clinical trials, including our future clinical trials, include inability to raise funding, initiate or continue a trial, delays in obtaining regulatory approval to commence a trial, delays in reaching agreement with the FDA or other regulatory authorities on final trial design, imposition of a clinical hold following an inspection of our clinical trial operations or trial sites by the FDA or other regulatory authorities, delays in reaching agreement on acceptable terms with prospective contract research organizations and clinical trial sites, delays in obtaining required institutional review board approval at each site, delays in recruiting suitable patients to participate in a trial, delays in having subjects complete participation in a trial or return for post-treatment follow-up, delays caused by subjects dropping out of a trial, delays caused by clinical sites dropping out of a trial, time required to add new clinical sites or to obtain regulatory approval and open sites in geographic regions beyond the sites initially planned, and delays by our contract manufacturers to produce and deliver sufficient supply of clinical trial materials.
- The Company’s working capital deficiency was $5,998,712 and $7,652,098 as of December 31, 2024 and 2023, respectively.
- There is substantial doubt as to our ability to continue as a going concern.
- Even if we comply with all FDA requests, we cannot be sure that we will ever obtain regulatory clearance for any of our drug product candidates.
- Future sales by our stockholders may adversely affect our stock price and our ability to raise funds in new stock offerings.