ADDED
On March 24, 2026, there were 10,306,079 shares of the registrant s common stock outstanding.
Management s Discussion and Analysis of Financial Condition and Results of Operations 56 8.
Changes in and Disagreements with Accountants on Accounting and Financial Disclosure 65 9A.
With successful completion of the first Phase 3 FLASH ( F luorescent L ight A ctivated S ynthetic H ypericin) study and agreement from the European Medicines Agency ( EMA ) on the key design components of a confirmatory Phase 3 placebo-controlled study evaluating the safety and efficacy of HyBryte in the treatment of CTCL patients with early-stage disease, we began patient enrollment during December 2024 for the second Phase 3 study called FLASH2 ( F luorescent L ight A ctivated S ynthetic H ypericin 2).
Development programs in this business segment also include expansion of synthetic hypericin into psoriasis (SGX302), and our first-in-class Innate Defense Regulator ( IDR ) technology, dusquetide, for the treatment of inflammatory diseases, including aphthous ulcers in Beh et s Disease ( BD ) (SGX945) and oral mucositis in head and neck cancer (SGX942).
Our Public Health Solutions business segment includes development programs for (i) RiVax , a ricin toxin vaccine candidate, (ii) SGX943, a therapeutic candidate for antibiotic resistant and emerging infectious disease, and (iii) various vaccine programs, including a program targeting filoviruses (such as Marburg virus ( MARV ) and Ebola virus ( EBOV )) and CiVax , a vaccine candidate for the prevention of COVID-19 (caused by SARS-CoV-2).
Expand development of dusquetide under the research name SGX945 into BD by conducting a Phase 2 clinical trial, where previous studies with dusquetide in BD have validated the biologic activity in aphthous ulcers in BD.
Continue development of our heat stabilization platform technology, ThermoVax , in combination with programs for RiVax (ricin toxin vaccine), and filovirus vaccines (targeting EBOV, Sudan virus ( SUDV ), and MARV and multivalent combinations), with U.S.
In both settings, it appears that the mode of action is an induction of cell death in a concentration as well as a light dose-dependent fashion.
A confirmatory, placebo-controlled Phase 3 study based upon an EMA-accepted protocol is actively enrolling with interim analysis expected in the second quarter of 2026 and top-line results expected in the second half of 2026.
REMOVED
On March 14, 2025, there were 3,155,603 shares of the registrant s common stock outstanding.
Management s Discussion and Analysis of Financial Condition and Results of Operations 54 8.
Changes in and Disagreements with Accountants on Accounting and Financial Disclosure 64 9A.
Any fractional shares that would otherwise have resulted from the reverse stock split were rounded up to the next whole number.
Our common stock began trading on The Nasdaq Capital Market on a reverse split basis at the market opening on June 6, 2024.
All share and per share data have been restated to reflect this reverse stock split.
With successful completion of the first Phase 3 FLASH (Fluorescent Light Activated Synthetic Hypericin) study and agreement from the European Medicines Agency ( EMA ) on the key design components of a confirmatory Phase 3 placebo-controlled study evaluating the safety and efficacy of HyBryte in the treatment of CTCL patients with early stage disease, we began patient enrollment during December 2024 for the second Phase 3 study called FLASH2 (Fluorescent Light Activated Synthetic Hypericin 2).
Development programs in this business segment also include expansion of synthetic hypericin (SGX302) into psoriasis, and our first-in-class Innate Defense Regulator ( IDR ) technology, dusquetide (SGX942 and SGX945), for the treatment of inflammatory diseases, including oral mucositis in head and neck cancer and aphthous ulcers in Beh et s Disease.
Our Public Health Solutions business segment includes development programs for RiVax , our ricin toxin vaccine candidate and SGX943, our therapeutic candidate for antibiotic resistant and emerging infectious disease and our vaccine programs targeting filoviruses (such as Marburg and Ebola) and CiVax , our vaccine candidate for the prevention of COVID-19 (caused by SARS-CoV-2).
Following feedback from the United Kingdom ( UK ) Medicines and Healthcare products Regulatory Agency ( MHRA ) that a second Phase 3 clinical trial of SGX942 (dusquetide) in the treatment of oral mucositis would be required to support a marketing authorization, design a second study and attempt to identify a potential partner(s) to continue this development program.