QSAM Bioscience, Inc. (QSAM)


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QSAM Biosciences, Inc.

 Website: https://qsambio.com

QSAM Biosciences SEC Filings

QSAM Bioscience, Inc. (QSAM) holds the worldwide license for CycloSam (Samaium-153 DOTMP), a clinical stage novel radiopharmaceutical meant to treat different types of bone cancer and related diseases. This isn’t just bone cancer. This drug could be used to treat OsteoSarcoma and Bone Metastasis. There has been no new treatment for OsteoSarcoma in the last 40 years. Forget about the fact that this is a billion dollar market. OsteoSarcoma and Bone Metastasis are both very common in Ewing Sarcoma, which is a cancerous tumor that grows in the bones, or in the tissue around bones, of children. The result is often amputation of the affected limb. QSAM could change this.

Read this great CEO Letter dated November 24, 2020 for more information on QSAM. QSAM Biosciences Issues Letter from New CEO; Presents Opportunities Ahead for Company

QSAM is expecting to start the FDA approval process for CycloSam after the first of the year. The market cap on this company is much lower than just about every other company in the FDA approval process. The great thing about CycloSam is that the FDA has already approved it as Quadramet, which is an injectable radiopharmaceutical used for pain relief in cancer patients suffering from osteoblastic metastatic bone lesions. QSAM will be looking for FDA approval on CycloSam as a chelate vehicle that carries the drug that can stop the growth of a tumor to the site of the growth.

This nuclear technology uses low specific activity Samarium-153 (resulting in far less europium) and DOTMP, a chelator which is believed to eliminate off-target migration and targets high bone turn over making it an ideal agent to treat OsteoSarcoma, bone metastases and to perform bone marrow ablation. Sm-153 DOTMP has been cleared by the FDA under an investigator initiated IND to commence human dosing of cancer patients.

QSAM Therapeutics, Inc.

QSAM Therapeutics, Inc. (“QSAM”), a wholly-owned subsidiary of QSAM Biosciences, Inc. (OTCQB: QSAM), is developing next generation nuclear medicines for the treatment of cancer and related diseases and conditions.

QSAM’s initial technology is Samarium-153 DOTMP, aka CycloSam®, a clinical-staged bone targeting radiopharmaceutical​ from IsoTherapeutics Group, leaders in the nuclear medicine space who also developed FDA-approved and commercially available Quadramet® (Samarium-153 EDTMP), indicated for pain palliation.

CycloSam® has already demonstrated safety and efficacy in animal studies and a human trial performed at the prestigious Cleveland Clinic. This drug candidate utilizes an FDA approved radioisotope combined with a novel chelate that has demonstrated increased efficacy and decreased side effects in animal models. Further, CycloSam® utilizes a streamlined, just-in-time manufacturing process. Given these factors, management believes there is a strong pathway to commercialization.

CycloSam® is cleared by the FDA under an investigator IND to commence human dosing immediately in patients with osteosarcoma and bone metastasis. CycloSam® was also cleared by FDA and successfully used under a single-patient IND to perform bone marrow ablation prior to allogenic marrow transplantation (BMA/T) in 2020. 

Interested investors can find out more about QSAM Biosciences, Inc. and the Company’s wholly-owned subsidiary, QSAM Therapeutics, Inc. by visiting https://qsambio.com
*Nuclear Medicine Market Size Worth $12.6 Billion by 2027 | CAGR 9.5%

According to report published by Grand View Research, the global nuclear medicine market size was valued at USD 6.1 billion in 2019 and is estimated to witness a CAGR of 9.5%during the forecast period.

The global Nuclear Medicine Market size is expected to reach USD 12.6 billion by 2027, expanding at a CAGR of 9.5%, according to a new report by Grand View Research, Inc. Research and development of advanced technologies by the key players for diagnosis and treatment of diseases is expected to drive the radiopharmaceuticals market.

QSAM Management

In our opinion, the reason you want to look at QSAM can be summed up in one word, management. You will not find a management team of this caliber in any other small cap company with a $7 million market cap. Doug Baum, the CEO, has been in drug development since 1991. He has provided FDA navigance on several drugs that are already on the market. Dr. Richard Piazza is the Executive Chairman and he has had four successful exits on biotech companies. These guys are rock stars. I’m including their bios from the website https://qsambio.com. We will be putting together a more extensive report and do a deeper dive into their background, but wanted to get the word out on QSAM.

Douglas R. Baum – Chief Executive Officer, President and Director

Douglas R. Baum has 28+ years of experience serving in a number of executive management and business development positions within the drug development and life sciences industries. Currently, he serves as the CEO, President and Director of QSAM and its subsidiary, QSAM Therapeutics, Inc., a company he co-founded in 2019. QSAM is an Austin, Texas based clinical stage specialty pharmaceutical company developing a pipeline of radiopharmaceuticals focused on various bone and solid tumor cancers.

Previously, Doug was the President and CEO of Xeris Pharmaceuticals Inc. (NASDAQ: XERS) a specialty pharmaceutical company focused on developing drugs for diabetes and related metabolic diseases. Prior to Xeris he served as the COO of MacuCLEAR, a specialty pharmaceutical company developing novel treatments for retinal diseases of the eye. Prior to MacuCLEAR, Doug served as the Vice President, Global Corporate Development at Premier Research Group (PRG), Inc. a global contract research organization serving the pharmaceutical, biotechnology and medical device industries. In 2007 PRG acquired SCIREX Corporation where Doug served as Executive Vice President & General Manager, Early Drug Development. He also serves on the Board of Directors of Regent Technologies, Inc. and previously served on the boards of Xeris, MacuCLEAR, Halsa Pharmaceuticals, Inc. and the Texas Medical Device Alliance.

Doug obtained his Bachelor’s of Business Administration degree and his Master’s of Science in Technology Commercialization degree from the University of Texas at Austin.

C. Richard Piazza, Ph.D. – Executive Chairman

C. Richard Piazza, Ph.D. is a career healthcare executive with 48 years of experience in medical devices as well as the pharmaceutical/biotechnology sectors. Included in this is 44 years in general management positions in both public and private international companies including Ohmeda, Smith & Nephew Pharmaceuticals, Marquest & VitaGen (world’s first bioartifical liver). In 2019 he co-founded QSAM Therapeutics, Inc. with Doug Baum and currently serves as its Executive Chairman.

Richard has gained a reputation of not only introducing new technologies and driving them to success but recruiting and motivating “world class,” highly focused management teams. In addition to a highly successful business career, Richard has served on industry association boards & committees (Advamed, Biocomm, BioHouston etc.) and was an industry representative working with the FDA and the Congress to craft the FDA Modernization Act for Medical Devices. His Board experience also includes numerous directorships and Chairman roles in both public and private healthcare companies. In addition to industry affiliations, Richard remains committed to working with well-known medical pioneers to identify and advance new technologies. He acts as an advisor to some of world’s leading institutions. These include MD Anderson Cancer Center, Baylor College of Medicine, University of California San Diego, University of Chicago & Kings College Hospital (London.) Richard has been a guest Lecturer in Sales & Marketing strategy at numerous Universities including Rice University School of Management, UCLA, University of Wisconsin, CAL Tech-MIT forum, University of British Columbia & University of California San Diego.

Richard obtained a BS in Economics and a BS in Speech Pathology from the State University of New York and MA & PhD in Economics from the University of Buffalo and Leeds University.

Barry Sugarman – Senior Advisor

Barry Sugarman is a Senior Executive Generalist with over 30 years of experience spanning public and private companies in the pharmaceutical, medical device, dietary supplement, and cosmetic industries. Barry has considerable direct experience in pharmaceutical product development, manufacturing, clinical trials, regulatory affairs, FDA and government relations, marketing, and distribution.

Barry possesses broad experience in clinical trial operations and management, mergers, acquisitions, turnarounds, startups, reorganization, process improvements, and sales management and a very strong knowledge of Good Manufacturing Practices (GMP’s), Good Clinical Practices (GCP’s), Good Laboratory Practices (GLP’s), and International Conference for Harmonization (ICH) requirements. He is an author and co-author of numerous FDA filings and approvals including Investigational New Drug Applications (IND’s), New Drug Applications (NDA’s), Abbreviated New Drug Applications (ANDA’s), and Medical Device Applications 510(k)’s.

Barry is a member of the Regulatory Affairs Professional Society (www.raps.org), American Association of Pharmaceutical Scientists (www.aaps.org), Association of Clinical Research Professionals (www.acrpnet.org), and the National Association of Corporate Directors (www.nacdonline.org). He is a co-author of “Prompt, Accurate Diagnosis of Pediatric Cancer and Leukemia for Pediatricians, Orthopedists, and Family Practitioners” – Paperback (Aug. 28, 2007) by Andrew Pendleton, Jennifer Minigh, Lainie Shapiro, and Barry Sugarman.

R. Keith Frank, Ph.D. and Jim Simon, Ph.D. – Scientific Advisory Board

Over 30 years experience each with Dow Chemical leading R&D efforts in Radiopharmaceuticals & Chelators
Developed Quadramet®
Founded IsoTherapeutics in 2005 performing contract R&D for Big Pharma with emphasis on radiolabeling
Authored/co-authored more than 100 scientific papers & publications
Recognized as leading authorities in radiopharmaceuticals
60+ Patents
Internationally recognized experts in radiopharmaceuticals
Extensive interaction with research institutions, investigators and hospitals

Charles J. Link Jr, M.D. – Board of Directors

Dr. Link brings decades of biotech and drug development experience to QSAM. He currently serves on the executive committee of the Board of Directors at NovaScan Inc., a clinical-stage company focused on cancer detection; and is the founder and President of biotech startup Syncromune. Previously, Dr. Link was the CEO, CSO, Chairman, and founder of NewLink Genetics, a NASDAQ-listed immunotherapy company focused on developing novel immuno-oncology product candidates. During his tenure at NewLink, Dr. Link led a series of collaborative transactions totaling hundreds of millions of dollars with Merck, Roche and the United States government. He also oversaw the collaboration with Merck to develop EVERBO, the first Ebola vaccine to receive FDA approval. Prior to founding NewLink Genetics, Dr. Link was an attending physician at the National Cancer Institute. He has authored more than 150 peer-reviewed papers. He previously received funding from the National Institute of Health, the National Cancer Institute, the American Cancer Society, and others. Dr. Link received an M.D. from Stanford University, and he attended the Air Force Academy.

OTC Symbol: QSAM

Current Price: $0.70 x $0.72

Shares Outstanding: 15,524,020

Restricted Shares: 14,181,258

Unrestricted: 1,342,762

Held at DTC: 1,266,401

Float: 914,666
Market Cap: $10.9 million

52 Week Trading Range:
52-Week Low: $0.20
52-Week High: $2.10

Corporate Offices:
420 Royal Palm Way, #100,

Palm Beach, FL 33480
Contact Information
Website: www.qsambio.com

Phone: (561) 693-1423

Company Officers/Contacts:

Douglas R. Baum – Chief Executive Officer, President and Director

C. Richard Piazza, Ph.D. – Executive Chairman

Barry Sugarman – Senior Advis

R. Keith Frank, Ph.D. – Scientific Advisory Board

Jim Simon, Ph.D. – Scientific Advisory Board

Charles J. Link Jr, M.D. – Board of Directors