QSAM Biosciences (OTCQB: QSAM), a company developing next-generation therapeutic radiopharmaceuticals, including Samarium-153-DOTMP, or CycloSam(R), for the treatment of bone cancer and related diseases, has provided key updates and milestone goals in a shareholder letter; the letter is from QSAM Biosciences executive chair and cofounder C. Richard Piazza and CEO and cofounder Douglas Baum. The letter noted that QSAM is developing its 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. During 2022, CycloSam received rare pediatric disease designation for the treatment osteosarcoma. The company also reported dosing the initial two patients in its phase 1 clinical trial, establishing two clinical trial sites and completing an estimated $1.5 million in common stock and warrant funding.
The letter outlined goals for 2023 to complete the phase 1 study, secure capital through an underwritten offering and a concurrent NASDAQ uplisting. “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 (groupings) 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,” said the QSAM executives in the shareholder letter. “We are looking forward to progress in 2023, which we expect will create fundamental value for our shareholders. While we cannot predict the tide of external market forces, we are confident in our team, our technology, and our ability to advance CycloSam through the FDA process. Ultimately, however, our primary mission is to help the hundreds of thousands of adults and children each year suffering from bone cancer.”
To view the full letter, visit https://ibn.fm/ko0Lb
About QSAM Biosciences Inc.
QSAM Biosciences is developing next-generation nuclear medicines for the treatment of cancer and related diseases. QSAM’s initial technology, CycloSam (Samarium-153 DOTMP), is a clinical-stage, bone-targeting radiopharmaceutical developed by IsoTherapeutics Group LLC, pioneers in the nuclear medicine space that also developed the FDA-approved Quadramet(R) (Samarium-153 EDTMP) radiopharmaceutical product, which is indicated for pain palliation. QSAM is led by an experienced executive team and board of directors that have completed numerous FDA approvals and multiple successful biotech exits. CycloSam has demonstrated preliminary safety and efficacy in animal studies and a single patient FDA-cleared human trial performed in 2020 at the Cleveland Clinic. This nuclear technology uses low specific activity Samarium-153 (resulting in far less undesirable europium impurity) and DOTMP, a chelator that targets sites of high mineral turnover (bone) and is believed to reduce or eliminate off-target migration, making it, in management’s opinion, an ideal agent to treat primary and secondary bone cancers. Since CycloSam delivers targeted radiation selectively to the skeletal system, it is also believed to be an important candidate for use in bone marrow ablation as preconditioning for bone marrow transplantation as well as in procedures to reduce external beam radiation to bone tumors. This multi-patented drug candidate utilizes a radioisotope previously approved by the FDA, combined with a novel targeting chelant that has demonstrated preliminary increased efficacy and decreased side effects in animal models and veterinary treatment of bone cancer in dogs. Further, CycloSam utilizes a streamlined, just-in-time manufacturing process that is well established. For more information about the company, please visit www.QSAMBio.com
NOTE TO INVESTORS: The latest news and updates relating to QSAM are available in the company’s newsroom at http://ibn.fm/QSAM
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