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QSAM Promotional Newsletter
The following is a newsletter released by "OTC Stock Review" promoting QSAM Biosciences Inc.
QSAM Biosciences Inc.
Today we got the news on QSAM we've been looking for
QSAM Biosciences Announces Submission of IND Application for CycloSam with FDA
Austin, TX, May 04, 2021 GLOBE NEWSWIRE -- QSAM Biosciences Inc. OTCQB QSAM, a company developing next-generation nuclear medicines for the treatment of cancer and related diseases, announced today that it has submitted an Investigational New Drug IND application with the U.S. Food and Drug Administration FDA for the initiation of a Phase 1 clinical trial of Samarium-153 DOTMP CycloSam in patients with bone cancer. The IND submission was submitted fully electronically, was compliant with all current FDA electronic document requirements, and was accepted for review by the FDA.
This IND submission is an important accomplishment for QSAM as we continue to advance the development of CycloSam for the treatment of several types of primary and metastatic bone cancers, stated Douglas R. Baum, the Companys CEO and Co-Founder. We look forward to commencing this study and additional clinical trials to demonstrate the safety and efficacy of CycloSam in patients with primary and secondary bone cancer.
The first proposed clinical trial included in the IND is a dose escalation and dose finding study of CycloSam to treat solid tumors in the bone or metastatic to the bone. A wide group of all tumors metastatic to the bone from prostate, lung, and breast cancer are proposed to be eligible for this clinical trial.
In parallel with this regulatory submission, the Company has contracted with a well-established contract research organization CRO and is actively recruiting investigators and clinical trial sites to participate in this study, and expects to begin enrolling patients mid-year. The FDA has already cleared an investigator-initiated IND for CycloSam for the treatment of osteosarcoma, and a second single-patient IND in 2020 for a bone marrow ablation procedure prior to stem cell transplantation.
QSAM Bioscience, Inc. OTCQB QSAM holds the worldwide license for CycloSam Samaium-153 DOTMP, a clinical stage novel radiopharmaceutical therapy meant to treat different types of bone cancer and related diseases. Preliminary results of early studies support a potentially favorable safety and efficacy profile of Cyclosam. As a result of this, as well as a number of animal studies and one human trial conducted this past summer, and the streamlined manufacturing process that is already in place, QSAM is optimistic about the chances of advancing Cyclosam through the FDA process over the coming years. CycloSam is designed to specifically and safely deliver targeted radiation therapy to kill cancer cells in and near the bone. CycloSam is a significantly improved version of another FDA approved and commercialized radiopharmaceutical developed by the same inventors, but with the possibility of broader commercial indications.
The market for Cyclosam includes osteosarcoma, metastatic bone cancers from the breast, prostate and lungs, bone marrow ablation, and the reduction in external radiation. There has been no new treatment for OsteoSarcoma in the last 40 years, which along with Bone Metastasis, are both very common in Ewing Sarcoma. Ewing Sarcoma 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. In the first half of 2021 QSAM plans to commence a new, multi-site clinical trial in the US to further the development of the therapy. QSAM has two issued patents in the US, one allowed patent in Europe and fitsteen pending patents that protect the use of Cyclosam as a radiopharmaceutical in the U.S. and internationally.
QSAM IND with the FDA for Phase 1 clinical trial of Samarium-153 DOTMP CycloSam
QSAM is expecting to an Investigational New Drug IND application with the U.S. Food and Drug Administration FDA sometime in the second quarter of 2021 for the initiation of a Phase 1 clinical trial of Samarium-153 DOTMP CycloSam in patients with bone cancer. 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.
About Samarium-153 DOTMP, aka CycloSam
QSAMs 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 BMAT in 2020.
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 an $11 million market cap.
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 Bachelors of Business Administration degree and his Master 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 pharmaceuticalbiotechnology 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 worlds 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 worlds 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.
Charles J. Link Jr, M.D. Medical Director, 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.
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 GMPs, Good Clinical Practices GCPs, Good Laboratory Practices GLPs, 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 INDs, New Drug Applications NDAs, Abbreviated New Drug Applications ANDAs, and Medical Device Applications 510ks.
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 RD efforts in Radiopharmaceuticals Chelators
Founded IsoTherapeutics in 2005 performing contract RD for Big Pharma with emphasis on radiolabeling
Authoredco-authored more than 100 scientific papers publications
Recognized as leading authorities in radiopharmaceuticals
Internationally recognized experts in radiopharmaceuticals
Extensive interaction with research institutions, investigators and hospitals.
Richard K. Burt, M.D. Scientific Advisory Board
Over the last 35 years, Dr. Burt pioneered the use of hematopoietic stem cells to treat autoimmune diseases and he was among the first doctors in the United States and the World to perform autologous hematopoietic stem cell transplants for numerous immunemediated diseases including rheumatoid arthritis, multiple sclerosis, systemic lupus erythematosus, Crohns disease, type 1 diabetes, and other serious conditions. He was the first Autoimmune Committee Chairperson for the International Bone Marrow Transplant Registry IBMTR and was the principal investigator of a National Institute of Health NIH $10 million multi-center contract to develop stem cell clinical trials for autoimmune diseases.
In 2006, Dr. Burt was recognized by Scientific American along with Al Gore and Steve Jobs as one of the top 50 people in the world for improving humanity due to his pioneering stem cell work. In 2011, Science Illustrated recognized Dr. Burts stem cell work as one of the top 10 advances of the decade.
QSAM Is Primed to Achieve Near-Term, Value-Driving Objectives
QSAM has secured promising drug technology to treat bone cancer. In April 2020, we licensed on a worldwide, exclusive basis a novel and patented radiopharmaceutical called CycloSam, meant to target cancers that develop in or metastasize to the bone.
QSAM has established a management team of seasoned biotech experts. In November we appointed as its new Executive Chairman, C. Richard Piazza, who has more than 45 years of healthcare experience in both medical devices and pharmaceuticalbiotech development and has led several technology companies to market success including numerous FDA approvals in both sectors. QSAM also appointed Douglas Baum, as its CEO. Doug brings over 28 years of experience in the bioscience and biotech industries, overseeing 15 product approvals through the FDA. In February 2021, QSAM appointed a new independent director, Dr. Charles J. Link Jr., who brings decades of biotech and drug development experience to QSAM, including serving as CEO, CSO, Chairman, and founder of NewLink Genetics, a NASDAQ-listed immunotherapy company focused on developing novel immuno-oncology product candidates.
QSAM completed its Series B preferred stock offering in November, and by January 2021 the Company had closed on $2.5 million in funding to support its clinical trials and operations through 2021. In connection with this offering, QSAM also issued short-term warrants that, if exercised, could provide another $2 million in funding around the end of the second quarter of 2021.
QSAM has significantly reduced its debt and divested its legacy business. In 2020 QSAM converted almost $14.3 million in debt, promissory notes, accrued compensation and other liabilities into common stock. By March 31, 2021, QSAM had eliminated the remaining amount of approximately $1.5 million in debt, leaving just $35,000 in convertible debentures currently on its books. In connection with the equity raise completed in January, its balance sheet as of the present date has never been stronger.
12 to 24 month Objectives
Building upon this solid foundation through 2021 QSAM expects to demonstrate advancements from the achievement of several important milestones, including
Filing and ultimate clearance of its IND with the FDA to start clinical trials with CycloSam
Dosing of the first patient in the Phase 1 trials with CycloSam
Announcement of initial Phase 1 results of CycloSam possibly in 2022
Expansion of its intellectual property portfolio with newly issued patents
Possible acquisition of a second radiopharmaceutical asset to expand its product pipeline and
Adding additional biotech expertise to its team.
OTCQB Symbol QSAM
Current Price $0.40
Shares Outstanding 27,497,850
Restricted Shares 22,180,128
Held at DTC 5,241,361
Market Cap $11 million
52 Week Trading Range
52-Week Low $0.20
52-Week High $2.10
9442 Capital of Texas Hwy N,
Austin, TX 78759
Phone 512 343-4558
Douglas R. Baum Chief Executive Officer, President and Director
C. Richard Piazza, Ph.D. Executive Chairman
Barry Sugarman Senior Advisor
Charles J. Link, M.D. Medical Director
R. Keith Frank, Ph.D. Scientific Advisory Board
Jim Simon, Ph.D. Scientific Advisory Board
Dr. Richard Burt - Scientific Advisory Board
OTC Stock Review is not registered as an Investment Advisor or a BrokerDealer. The information in this newsletter is not an offer to buy or sell securities of the companies profiled. Information is for informative purposes, not intended as advice for investment and is subject to change without notice. OTC Stock Review has been compensated one hundred thousand shares of QSAM common stock restricted under Rule 144 to perform investor relations services for QSAM. Officers and directors of OTC Stock Review may hold a long equity position in QSAM and may from time to time trade in these securities for their own accounts. Information on each company is from public releases and can not be guaranteed by OTC Stock Review. Companies profiled herein may carry a high investment risk readers should carefully review profiled companies thoroughly with their investment advisor, stockbroker, or other such professional. OTC Stock Review is not liable for any investment decisions by its readers or their advisors. Any analysis contained herein does not purport to be a complete analysis of the profiled Companies and reflects the opinion of the author. Readers should obtain copies of the profiled Companys periodic reports filed with United States Securities and Exchange Commission, generally available at or .
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Last 2 Stock Promotions By "OTC Stock Review"
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