QSAM Biosciences Inc. (OTCQB: QSAM)

QSAM Biosciences Inc. (OTCQB: QSAM) is a clinical stage biotechnology company focused on bringing to market targeted therapeutic radiopharmaceuticals. The company is committed to advancing the fight against cancer through the discovery, development and delivery of effective treatment options for adult and pediatric patients.

QSAM Biosciences was founded in 2020 by Executive Chairman Dr. C. Richard Piazza and CEO Douglas Baum. It is headquartered in Austin, Texas.

CycloSam®

CycloSam®, QSAM Biosciences' initial technology, is a clinical-stage bone targeting radiopharmaceutical invented by world-renowned scientists at IsoTherapeutics Group LLC. By leveraging a patented, low specific activity form of Samarium-153 (resulting in far less undesirable europium impurity) and what management believes to be a superior chelating agent in DOTMP, CycloSam is designed to selectively target sites of high bone mineral turnover to deliver a prescribed tumor-killing dose of radiation to the bone tumor sites while minimizing radiation exposure to nearby healthy tissue. These parameters are currently being tested in an FDA-cleared clinical trial.

CycloSam® has been shown in laboratory testing to cause significantly less (30x less) buildup of long-lived radionuclidic impurities than prior FDA-approved drugs, which management believes will enable the ability to safely administer therapeutic doses via higher and multiple-dose regimens and effectively expand its potential clinical utility to therapeutic uses in areas of high unmet medical needs.

The indications for CycloSam® currently being evaluated by QSAM Biosciences include:

• Metastatic Bone Cancers – On April 28, 2022, QSAM Biosciences announced that the first patient had commenced treatment in its clinical trial evaluating CycloSam in patients with metastatic bone cancer. As noted in the release, the study is a Phase 1 open-label, dose-escalation trial to evaluate the safety, tolerability, dosimetry, and preliminary efficacy of CycloSam®.
• Pediatric Osteosarcoma/Ewing's Sarcoma – On February 2, 2022, the company announced that the U.S. FDA has granted Rare Pediatric Disease Designation to CycloSam for the treatment of osteosarcoma. Combined with a previously granted orphan drug designation for osteosarcoma received in 2021, this milestone "may allow QSAM to potentially bring CycloSam® to market more rapidly through additional incentives and eligibilities," according to CEO Douglas Baum.
• Bone Marrow Ablation – In a 2020 single patient Investigational New Drug (IND) study, an investigator concluded that high-dose CycloSam® can be administered safely to ablate bone marrow in advance of a stem cell transplant with no apparent renal toxicity and no unexpected adverse events attributable to the drug.

QSAM Biosciences' preclinical and clinical development pipeline is supported by a strong IP portfolio. The company has secured 14 patents across three distinct patent families spanning the U.S., Japan, Canada and the European Union.

Market Outlook

Through its ongoing development of CycloSam®, QSAM Biosciences is targeting multiple large and underserved market opportunities. According to the American Cancer Society, roughly 400,000 new cases of malignant bone metastasis are diagnosed annually in the U.S. alone. Additionally, QSAM will pursue indications for osteosarcoma and Ewing's sarcoma that are the most common primary malignancies of bone tissues in children.

Despite this pressing need, the current standard of care for bone cancer is aggressive and suboptimal, leading to marginal success with significant side effects and poor long-term survival prognosis. As a result, QSAM Biosciences estimates a sizable market opportunity for its development pipeline.

• Bone Metastasis has an estimated total addressable market of $20 billion in the U.S. based on total new cases and comparable drug pricing.
• Osteosarcoma/Ewing's Sarcoma have a total addressable market of roughly $125 million in the U.S. based on approximately 1,000 new cases in 2021.
• The total addressable market for Bone Marrow Ablation is projected at $1 billion, with an estimated 32,000 procedures completed annually.

The company anticipates that the ability to administer CycloSam® for higher and multiple-dose regimens may expand its clinical utility for therapeutic uses in additional areas of high unmet medical needs.

Management Team

QSAM Biosciences is led by an experienced management team and board with an extensive record of FDA approvals, big pharma partnerships and M&A transactions.

Dr. C. Richard Piazza is the Executive Chairman of QSAM Biosciences. Since 2017, he has also served as President and CEO of IGL Pharma Inc., the licensor of CycloSam®, and as a consultant to IsoTherapeutics Group LLC, the inventors of the technology. Dr. Piazza also currently serves on the board of directors of NovaScan LLC, a privately held cancer detection and diagnostics company. He has more than 48 years of health care experience in both medical devices and pharmaceutical/biotech and has led several technology companies to market success, including numerous FDA approvals in both sectors. Dr. Piazza obtained a BS in Economics and a BS in Speech Pathology from the State University of New York and an MA & PhD in Economics from the University of Buffalo and Leeds University.

Douglas R. Baum is the company's CEO and Director. He brings to QSAM Biosciences over 30 years of experience in the bioscience and biotech industries, including development, FDA/EMA approval and commercialization of multiple drugs and medical devices. Mr. Baum has overseen 15 product approvals through the FDA and EMA and raised over $85 million in capital to fund breakthrough technologies. From 2017 to 2020, he consulted with multiple medical schools and biotech and pharmaceutical companies, and, from 2012 to 2017, he served as President, Chief Executive Officer and Director of Xeris Pharmaceuticals Inc. Mr. Baum holds a Master of Science in Technology Commercialization and a BBA in International Business and Marketing from the University of Texas.

Adam King is the CFO of QSAM Biosciences. He is also the Founder and CEO of King Consulting Group, where he provides a range of financial and reporting services for clients. Before founding King Consulting Group in January 2021, Mr. King was the CFO for Netsertive, a venture-backed digital marketing company. From 2016 to 2018, he was the Office Managing Audit Director for BDO's Greenville, South Carolina, office, in addition to serving as Audit Director in Raleigh, North Carolina, and Boston, Massachusetts. While at BDO, Mr. King worked with various clients, from tech and life science start-ups to billion-dollar publicly traded companies. He holds a Bachelor of Science in Accounting from Elon University and is a CPA in Raleigh, North Carolina.