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QSAM Biosciences Inc. (QSAM)

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Last Post: 2/20/2021 2:31:27 PM - Followers: 12 - Board type: Free - Posts Today: 0

QSAM Biosciences

9442 Capital of Texas Hwy N
Plaza 1 Suite 500
Austin, TX 78759
United States
512 343 4558

Sector(s): Healthcare
Industry: Biotechnology
Full Time Employees: 5

QSAM Biosciences SEC Filings https://www.sec.gov/cgi-bin/browse-edgar?CIK=1310527&owner=exclude
QSAM Biosciences Press Releases https://www.globenewswire.com/en/Search?organization=QSAM%20Biosciences%20Inc.
Goldman Small Cap Research Report on QSAM Biosciences, Inc. (QSAM) https://bit.ly/3nGUocI

QSAM Biosciences, Inc. 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? developed by IsoTherapeutics Group LLC, leaders in the nuclear medicine space who also developed FDA-approved and commercially available Quadramet® (Samarium-153 EDTMP), indicated for pain palliation. CycloSam was assigned to IsoTherapeutics Group’s subsidiary, IGL Pharma, Inc.

CycloSam® has already demonstrated preliminary safety and efficacy in animal studies and a single patient FDA-cleared successful human trial performed in 2020. 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 sites of high bone turn over making it an ideal agent to treat osteosarcoma or other bone metastases. Osteosarcoma is the most common malignant bone tumor among children and adolescents. Because of its ability to deliver radiation to the skeletal system, it is also believed to be an effective agent to perform bone marrow ablation as pre-conditioning for bone marrow transplantation. This drug candidate utilizes an FDA approved radioisotope combined with a novel chelant 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 initiated 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.

The overall market for Radiopharmaceuticals is expected to exceed US$6.1 billion. The rising prevalence of cancer and cardiovascular diseases are the main factors driving the radiopharmaceuticals market.

QSAM Biosciences, Inc. (“QSAM”) is comprised of industry experts formed to acquire the rights to and seek commercialization of Samarium-153 DOTMP, aka CycloSam®, a bone targeting radiopharmaceutical? from IsoTherapeutics Group.

IsoTherapeutics’ scientists, leaders in the development of radiopharmaceuticals, also developed FDA approved and commercially released Quadramet® (Samarium-153 EDTMP), indicated for pain palliation.

CycloSam® shares the same FDA approved radioisotope as Quadramet®, but utilizes a novel chelate that had demonstrated preliminary increased efficacy and decreased side effects in animal models.

CycloSam® is cleared by the FDA under an investigator IND to commence human dosing immediately in patients with osteosarcoma and bone metastasis.

The study protocol, Principal Investigator, 1 clinical site and manufacturing plan are all finalized and the clinical trial is ready to commence. Additional sites are proposed to be coming online in the coming months to participate in the clinical trial.

CycloSam® is also cleared by the FDA under a second single-patient IND to perform bone marrow ablation prior to allogenic marrow transplantation (BMA/T).

Fifteen (15) patents under prosecution in the US and internationally; two of which have been issued.

What is CycloSam®?

CycloSam® is a bone seeking therapy designed to safely and specifically deliver targeted radiation therapy in the form of the radioisotope Samarium-153 (Sm-153) to areas of bone formation by employing the proposed superior chelant (a molecule that binds to positively charged metal ions) — DOTMP.

  • Sm-153 emits beta and gamma radiation and kills nearby cancer cells?
    Unlike other radiopharmaceuticals on the market, CycloSam® uses DOTMP, a proposed superior chelant to EDTMP used with Quadramet®
    CycloSam® uses the same Sm-153 radioisotope as Quadramet®, an FDA-approved and commercially released drug, but due to the proposed improved chelant, efficacy and safety are expected to be significantly improved.

Initial research has identified four initial potential indications for CycloSam®. that represent a large, multi-billion-dollar market. This includes osteosarcoma, metastatic bone cancers from the breast, prostate and lungs, bone marrow ablation, and the reduction in external radiation. Later this year, QSAM plans to commence a new, multi-site clinical trial in the US to further the development of the therapy. 





QSAM Leadership Team


The QSAM leadership team is made up of experts in the pharmaceutical, biotech, and medical devices industries.

Douglas BaumDouglas 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 PiazzaC. 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 SugarmanBarry 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

Keith Frank

Dr. R. Keith Frank

Dr. Jim Simon

Dr. Jim Simon
Charles J. Link Jr, M.D. - Board of Directors and Medical Director

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.
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QSAM News: Annual Statement of Changes in Beneficial Ownership (5) 02/16/2021 04:02:17 PM
QSAM News: Annual Statement of Changes in Beneficial Ownership (5) 02/16/2021 04:02:16 PM
QSAM News: Annual Statement of Changes in Beneficial Ownership (5) 02/16/2021 04:02:07 PM
QSAM News: Annual Statement of Changes in Beneficial Ownership (5) 02/16/2021 04:01:12 PM
QSAM News: Small Company Offering and Sale of Securities Without Registration (d) 02/05/2021 04:42:47 PM
#636  Sticky Note You are witnessing a pump of epic proportions... ChuckFinley305 01/27/21 08:48:20 AM
#557  Sticky Note WHY I THINK QSAM HAS A BRIGHT FUTURE! RandyKCMO 10/26/20 10:45:39 PM
#677   Thanks for the great post that is spot Notabadguy 02/20/21 02:31:27 PM
#676   I for one have not sold a share. Wrangler1 02/19/21 07:46:19 PM
#675   I'm going to go with Dr. Link over Notabadguy 02/19/21 03:20:34 PM
#674   What makes you think four or five positive Notabadguy 02/19/21 03:14:53 PM
#673   Why does the price always crash a couple ChuckFinley305 02/19/21 02:33:48 PM
#672   Nelson Christopher M. ChuckFinley305 02/17/21 08:52:18 AM
#671   Great add to the QSAM board. “During his Wrangler1 02/16/21 01:05:34 PM
#670   Sounds to me like QSAM is continuing to RandyKCMO 02/16/21 12:07:45 PM
#669   NEWS 2/16/2021 QSAM Biosciences Appoints Charles J. RandyKCMO 02/16/21 12:02:25 PM
#665   Yes it is. Good value un under $1 Wrangler1 02/09/21 09:32:40 PM
#664   I agree with you. QSAM's management team is Notabadguy 02/09/21 12:38:04 PM
#663   I continue to think they're are still better RandyKCMO 02/08/21 10:37:53 PM
#662   Great trade, man. I'm long since $0.28. Notabadguy 02/08/21 10:35:40 AM
#661   TICK TOCK $QSAM ;-) Penny Planet 02/08/21 09:35:51 AM
#660   Bid above the offer pre market. billionsmatter 02/08/21 09:01:18 AM
#659   It will take off well before they get Wrangler1 02/02/21 09:15:37 PM
#658   Actually I do. Once this product Mpphotopro 02/02/21 07:06:42 PM
#657   u really think this gonna take off? markgay 02/02/21 07:00:12 PM
#656   Nope. I’m dipping too. Good things ahead as Wrangler1 01/29/21 10:06:27 PM
#655   These flippers are crazy. Way bigger profits coming Mpphotopro 01/29/21 01:50:30 PM
#654   Y'all gonna let me buy this whole dip myself? Mpphotopro 01/29/21 10:45:18 AM
#653   There has been so much going on for Mpphotopro 01/29/21 08:49:15 AM
#652   Expecting a nice push today as savvy investors Penny Planet 01/29/21 08:08:09 AM
#651   So you think a 3 year old venture ChuckFinley305 01/29/21 07:54:46 AM
#650   I have to say... I was a little RandyKCMO 01/28/21 05:23:52 PM
#649   I don't know... it looks to me like RandyKCMO 01/28/21 05:22:26 PM
#648   NEWS QSAM Biosciences Closes Series B Preferred Private RandyKCMO 01/28/21 05:14:00 PM
#647   Great dip. I think the markets Mpphotopro 01/28/21 12:49:48 PM
#646   Great news. I see 5.00 in the future. Mpphotopro 01/28/21 09:09:39 AM
#645   $QSAM NEWS OUT —-> QSAM Biosciences Closes Series Penny Planet 01/28/21 09:06:31 AM
#644   The science is here folks. The proof Mpphotopro 01/27/21 03:24:47 PM
#643   Some big buys coming through now CSTI way lukin4winners 01/27/21 01:35:59 PM
#642   Here we go!!! $QSAM Penny Planet 01/27/21 01:34:53 PM
#641   Once CDEL is finished $1+ coming just have lukin4winners 01/27/21 01:04:14 PM
#640   I added a chunk today, it’s churning for Penny Planet 01/27/21 01:03:08 PM
#639   Adding here .86 chart is green reversal starting. lukin4winners 01/27/21 12:18:17 PM
#638   Like QSAM don't like the selling by CDEL. lukin4winners 01/27/21 10:54:48 AM
#637   These guys have a a buy recommendation from Mpphotopro 01/27/21 09:15:56 AM
#636   You are witnessing a pump of epic proportions... ChuckFinley305 01/27/21 08:48:20 AM
#635   CDEL buying a lot on the bid (not lukin4winners 01/26/21 02:07:38 PM
#634   Back to .88 important to keep green days lukin4winners 01/26/21 11:47:26 AM
#633   This little dip won't last much longer. Mpphotopro 01/26/21 11:37:42 AM
#632   Same here. I keep money on the Mpphotopro 01/26/21 10:23:45 AM
#631   Loading loading loading $QSAM Penny Planet 01/26/21 10:18:31 AM
#630   25.5K bid .75 they might have to hit lukin4winners 01/26/21 09:57:37 AM
#629   Adding while it's cheap and not many investors lukin4winners 01/26/21 09:40:43 AM
#628   Looking for that $1 break lots of big lukin4winners 01/26/21 09:36:23 AM
#627   I agree. QSAM has had several back Mpphotopro 01/26/21 09:35:56 AM
#626   Can't wait. Gotta be something huge Mpphotopro 01/26/21 09:21:46 AM
#625   Agree another hour and we would hit $1+ lukin4winners 01/25/21 06:11:34 PM
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