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QSAM Biosciences reported significant financial improvements in Q1 2021, highlighting a cash increase to $1.94 million from $8,300 at 2020's end, and reducing current liabilities to $389,000 from $4.19 million. Shareholder equity rose to $821,000 from a deficit of $5.1 million. Despite no revenue, operating expenses of $3.3 million included mainly non-cash charges. Key milestones include filing an IND with the FDA to begin clinical trials for CycloSam and engaging a CRO for trial management, with initial results expected in early 2022.
QSAM Biosciences Inc. (OTCQB: QSAM) announced the submission of an Investigational New Drug (IND) application to the FDA for a Phase 1 clinical trial of CycloSam® (Samarium-153 DOTMP) aimed at treating bone cancer. The IND submission was completed electronically and accepted for review. The study is a dose escalation and dose finding trial for various types of bone tumors. QSAM is also working with a contract research organization to recruit clinical investigators and sites, with patient enrollment expected to begin mid-year. Previous successes include FDA clearance for Osteosarcoma treatments.
QSAM Biosciences has appointed Dr. Richard K. Burt to its Scientific Board of Advisors. Dr. Burt is recognized for his expertise in stem cell procedures, vital for the high-dose applications of QSAM's radiopharmaceutical candidate, CycloSam. His experience spans over 35 years in using hematopoietic stem cells for treating autoimmune diseases and conducting NIH-backed clinical trials. The company anticipates that Dr. Burt's guidance will significantly enhance the development and commercialization of CycloSam, which has demonstrated safety and efficacy in both animal studies and a successful human trial.
QSAM Biosciences reported significant progress in 2020 and early 2021, including securing exclusive rights to CycloSam®, a novel treatment for bone cancer, and appointing industry veterans to its leadership team. The company completed a $2.5 million equity funding round and reduced its debt significantly, leaving only $35,000 in convertible debentures. Despite a net loss of $4.9 million in 2020, due largely to non-cash items, QSAM expects advancements in clinical trials and a strong balance sheet moving forward. The company anticipates filing for FDA clearance and initiating trials for CycloSam by mid-2021.
QSAM Biosciences has signed an Exclusive Option Agreement with IsoTherapeutics Group to secure a 120-day window for diligence and negotiation regarding a global license for BetaBrach™, a radiochemical therapy aimed at cancer treatment. This therapy aims to reduce the side effects commonly associated with traditional treatments by directly targeting tumors with beta radiation. The agreement aligns with QSAM's strategy to develop radiochemical assets for critical medical needs and follows their acquisition of CycloSam® rights.
QSAM Biosciences has appointed Charles J. Link Jr., M.D., to its Board of Directors as of February 15, 2021. Dr. Link will also serve as the company’s Medical Director. His extensive experience in managing drug development and breakthrough approvals is expected to drive QSAM’s growth. He emphasized the potential of CycloSam®, a promising treatment for bone cancers, particularly affecting children. The company also accepted the resignation of Scott S. Whitney from the Board, who served since 2016.
QSAM Biosciences Inc. (OTCQB: QSAM) reported on February 11, 2021, it became aware of promotional newsletters affecting its common stock. These newsletters, distributed from February 7-9, coincided with increased trading volume. QSAM clarified it had no prior knowledge of these promotions and urged investors to be cautious, emphasizing the misleading nature of claims regarding imminent FDA approval for its drug candidate CycloSam. The company noted significant activity due to recent financing, successful studies, and a European patent for its technology.
QSAM Biosciences Inc. has begun trading on the OTC Markets under the new symbol QSAM, replacing QPWR. This change follows the company's rebranding and new focus on developing the novel radiopharmaceutical, CycloSam, aimed at treating various bone cancers. CycloSam is expected to enter Phase 1 clinical trials in Q1 2021 and has been previously tested in human trials. The company holds exclusive global rights to this promising technology, signaling a strategic pivot to enhance its market position.