QSAM Biosciences Stock

QSAM Biosciences, Inc. engages in the business of developing a novel radiopharmaceutical drug candidate for the treatment of bone cancer.

The company is developing next-generation nuclear medicines for the treatment of cancer and related diseases. The company's initial technology is Samarium-153 DOTMP, also known as CycloSam (CycloSam or the New Technology), a clinical-stage bone targeting radiopharmaceutical. CycloSam features a patented, low specific activity form of Samarium-153, a beta-emitting radioisotope with a short 46-hour half-life, and the chelating agent DOTMP, which selectively targets sites of high bone mineral turnover and reduces off-site migration of the tumor-killing radiation.

In August 2021, the Food & Drug Administration (FDA) cleared the company's Investigational New Drug (IND) application to commence Phase 1 clinical trials for CycloSam as a treatment for cancer that has metastasized to the bone from the lung, breast, prostate and other areas. The company initiated this trial at its first site (Houston, TX) in November 2021 and to date it has dosed three patients, and has opened two other trial sites at Rutgers Cancer Institute of New Jersey and the Ellis Fischel Cancer Center at the University of Missouri. The company expects all 17 patients to be enrolled in its Phase 1 trial by the end of 2023, at which time it will seek to advance the study into a Phase 2 efficacy program.

Also in August 2021, the FDA granted Orphan Drug Designation for the use of CycloSam to treat a primary bone cancer called osteosarcoma, a devastating disease that mostly affects children and young adults; and in February 2022, the FDA granted Rare Pediatric Disease Designation for the same indication. In May 2020, CycloSam was also utilized in a Single Patient Investigational New Drug for Emergency Use at the Cleveland Clinic. As of December 31, 2022, CycloSam had completed animal studies in both small and large animals, including treating bone cancer in patient dogs at a university veterinary clinic.

CycloSam is a targeted, bone seeking radiopharmaceutical that combines the beta-emitting radioisotope Samarium-153 (153Sm) with a chelating agent, DOTMP (1, 4, 7, 10-tetraazacyclododecane-1, 4, 7, 10-tetramethylenephosphonic acid). Samarium-153 is acquired from a nuclear reactor from a third party and the chelating agent is supplied in the form of kits.

CycloSam utilizes a chelating agent called DOTMP that seeks out bone locations of high mineral turnover, typical in cancer cells and tumor growth. The DOTMP part of the molecule is taken up by calcium turnover locations in bones and carries the radioactive payload along with it. The radioisotope Samraium-153 emits radiation as it decomposes in the form of beta particles. Approximately 50% of the radioactivity concentrates in bone mineral with a very high lesion-to-normal bone ratio. The company's pre-clinical studies and single patient IND performed at the Cleveland Clinic has demonstrated that the remaining half of the administered activity is rapidly excreted through the kidneys.

CycloSam has a short half-life of 46 hours and is rapidly eliminated from the body. The final drug product of CycloSam is prepared from DOTMP kits and 153SmCl in 0.1 N HCl at a nuclear pharmacy local to the patient administration site. The final drug product is then delivered to the physician for use as an intravenous (IV) injection within 72 hours.

The company is enrolling patients in a Phase 1 multiple center, open label, dose escalation clinical trial intended to determine the maximum tolerated dose of CycloSam in participants, and also assess early efficacy signals. As of December 31, 2022, the company had completed the first of four patient groupings (cohorts), with a total of up to 17 participants expected to be enrolled.

In February 2022, the FDA cleared the company's amended protocol increasing the age criteria to participants 75 years old from the prior age limitation of 65. This amendment to the enrollment criteria expands the population of potential participants in QSAM's Phase 1 study evaluating CycloSam in the treatment of bone cancer.

Intellectual Property

Pursuant to the License Agreement, the company's IP estate includes 14 total patents issued and pending across three distinct patent families that provide protection for the use of CycloSam as a radiopharmaceutical in the U.S. and internationally. Under the License Agreement, the company holds three issued patents in the U.S., three issued patents in Japan, one issued patent in Canada, two allowed patents in Europe, and six pending patents in international jurisdictions.

CycloSam's therapeutic profile and presumed advantages over other radiopharmaceuticals, including Quadramet, translate to several potential key market indications as detailed in the following table:

License Agreement, Collaborations and Partnerships

License Agreement: The company, through its wholly-owned subsidiary QSAM Therapeutics, has an exclusive worldwide patent and technology License Agreement with IGL Pharma, Inc. (IGL). The company's License Agreement, as amended, with IGL is for 20 years or until the expiration of the multiple patents covered under the license and requires multiple milestone-based payments.

Contracted Research Organization: In January 2020, the company's licensor, IGL Pharma, entered into a Master Services Agreement (MSA) with a full-service Contract Research Organization (CRO) with over a 30 year history of service to pharmaceutical and biotechnology clients.

Research and Development

The company's research and development costs were $1,022,412 for the year ended December 31, 2022.

Government Regulation and Product Approval

The company must reach an agreement with the FDA on the proposed protocols for its future clinical trials, post-market safety monitoring, and on a Pediatric Development Plan in the United States. All new drugs require the presentation to the FDA after Phase II clinical trials have ended of a Pediatric Development Plan outlining the strategy and steps to be taken by the company to study CycloSam in children as appropriate.

Any products manufactured or distributed by the company pursuant to FDA approvals are subject to continuing regulation by the FDA, including requirements for record-keeping and reporting of adverse experiences with the drug and/or additional post-market clinical trials. Drug manufacturers are required to register their facilities with the FDA and certain state agencies and are subject to periodic unannounced inspections by the FDA and certain state agencies for compliance with current goods manufacturing practice regulations (cGMPs).

In the United States, the company is subject to complex laws and regulations pertaining to healthcare fraud and abuse, including, but not limited to, the Anti-Kickback Statute, the federal False Claims Act, and other state and federal laws and regulations. Except for the limitations excluded by the JOBS Act, the company is also subject to the Sarbanes-Oxley Act of 2002. The company is subject to the reporting requirements of Section 13 of the Exchange Act and subject to the disclosure requirements of Regulation S-K of the SEC, as a smaller reporting company.

History

The company was incorporated in 2004. The company was formerly known as Q2Earth, Inc. and changed its name to QSAM Biosciences, Inc. in 2020.