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 reported on its financial results for Q2, the period ended June 30, 2022; the company also noted that progress has been shown in its phase 1 clinical program designed to evaluate CycloSam, its proprietary radiopharmaceutical drug candidate for the treatment of metastatic bone cancer. Specifically, the report noted that preliminary evaluation of the first patient dosed in the phase 1 trial suggests promising results with second patient dosing and completion of the first cohort of patients in the trial is expected in the third calendar quarter along with additional clinical trial sites and nuclear reactor sites. The company also noted that it received a third key U.S. patent covering the production and delivery of CycloSam, further strengthening its extensive patent portfolio. Financial results show a $1.33 million net loss attributable to common stockholders for the quarter, along with operating expenses totaling $1.26 million for the quarter and an increase in professional fees of $0.07 million related to QSAM’s terminated public offering. “We are encouraged by the initial, preliminary data from the first patient dosed with CycloSam,” said QSAM Biosciences cofounder and CEO Douglas R. Baum in the press release. “While it is too early for formal conclusions to be made of these early results, we did see positive signals in terms of safety and efficacy. CycloSam performed how we expected it to perform, even given the lowest dosage in our dose-escalating study. Over the next few months, we expect to make steady progress in our first clinical trial, including establishing additional trial sites that will help us treat more patients, and qualifying additional nuclear reactors to build redundancy and efficiencies in our supply chain. . . . Our decision to postpone our planned equity raise and NASDAQ uplisting in May was based on market conditions at that time. We are now seeing the beginnings of a turnaround in the broader biotech markets. If these continue, and we achieve the progress we expect in our clinical trials over the next six months, we intend to revisit the uplisting process in early 2023. We are actively working toward creating shareholder value in conjunction with our most important mission to help adult and pediatric patients suffering from bone cancer.”
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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 have developed other FDA-approved radiopharmaceutical products. 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 and in procedures to reduce external beam radiation to bone tumors. This multipatented 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
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