QSAM Biosciences focused on completing Phase 1 study in 2023

QSAM Biosciences provides an update to shareholders regarding progress made in 2022 and milestone goals for 2023. The company said, "As many of you are aware, we are developing our lead therapeutic radiopharmaceutical drug candidate, CycloSam, to treat cancer that has either originated in the bone or has metastasized to the bone from the breast, prostate, lung, or other organs. These are areas of high unmet medical need that affect over 400,000 new patients a year in the US, and all too often results in death. Therapeutic radiopharmaceuticals are a relatively new sector in the fight against cancer that is experiencing significant growth in application among medical professionals and interest from global pharmaceutical companies. CycloSam is an asset that, in our opinion, is less risky from a clinical, manufacturing and regulatory standpoint than many other new drug development efforts. In addition to strong small and large animal data, we have initiated the clinical development for CycloSam with the benefit of human data showing efficacy in the treatment of bone tumors using a prior version of our radioisotope, Samarium-1531. We also have compelling data indicating safety in a single patient study we performed at the Cleveland Clinic in 2021.We believe that what we have accomplished to date demonstrates the experience of our management team in successfully and efficiently navigating drug candidates through the FDA process….Building upon these accomplishments, our goals for 2023 are clear and focused, primarily: Complete our Phase 1 study, consisting of up to 17 patients, and commence our Phase 2 study which will include providing patients with multiple doses of CycloSam over a four to six month regimen. We have preliminary data from prior investigators that demonstrates the efficacy in treating bone cancer when Samarium-153 is used on a repeated basis to bombard tumors, and we seek to replicate relevant portions of that study starting in late 2023 with our newer version of this targeted cancer-therapy radioisotope. Secure capital through an underwritten offering and concurrent NASDAQ uplisting to fund our clinical trials through Phase 2a, which we estimate to be approximately $12 – $15 million. Such a transaction, which we attempted but suspended in early 2022 due to market conditions, could provide our QSAM shareholders with added liquidity, and with what we believe to be a more appropriate valuation given the strength of our asset and progress achieved in our clinical studies. In reaching these goals, shareholders should expect to see progress through several nearer-term milestones, such as: securing additional trial sites and starting enrollment of patients at those sites; completing patient cohorts in our Phase 1 trial which will lead to escalating doses in subsequent cohorts; establishing a more robust supply chain through the qualification of additional nuclear reactors and other key vendors; and other important achievements."