QSAM Biosciences, Inc. (OTCQB: QSAM) @ 06/25/2021

Next Generation Nuclear Technology Focused on the Eradication of Bone Cancer

Management believes its initial technology, CycloSam® has a strong pathway to commercialization in a Global Market Size that is valued at $12.6 Billion*

BREAKING NEWS: QSAM submits application with FDA for Phase 1 clinical trial of Samarium-153 DOTMP (CycloSam®) in patients with bone cancer

Company Summary:

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 CycloSam® (Samarium-153 DOTMP), a clinical-staged bone targeting radiopharmaceutical that is cleared by the FDA under an investigator IND to commence human dosing immediately in patients with osteosarcoma and bone metastasis. The Company expects to enter Phase 1 clinical trials for CycloSam in the first half of this year.

Key Metrics @ 06/25/2021

Closing Price $0.34
52 Week Range $0.15 to $2.10
Shares Outstanding 27.73M
Shares in the Float  17.71M
Held @ DTC (06/27/2021) 8.64M
Shares Authorized 300M
Average Daily Volume: (10 day) 36.2k
Market Cap $8.88M
Reporting Status SEC Reporting
Financials Audited
Most Recent Filing: 10-Q  for 03/31/2021 Filed:  05/21/2021
Fiscal Year-end 12/31

(Source: OTC Markets, Yahoo Finance, SEC filings)

Corporate News:

QSAM Biosciences Issues Letter from CEO on Successful First Quarter 2021

Austin, TX, May 25, 2021 (GLOBE NEWSWIRE) — The Chief Executive Officer of QSAM Biosciences Inc. (OTCQB: QSAM), Douglas Baum, provided the following letter to shareholders today:

Dear Shareholders:

QSAM Biosciences had a transformative first quarter of 2021. We want to take this opportunity to summarize the progress we’ve made since the end of 2020, much of which can be found on our Form 10-Q filed with the SEC on May 20, 2021, as well as the latest on the development of our core radiopharmaceutical technology, CycloSam®.

Key Take-Aways from our March 31, 2021 Financial Statements and 10-Q

On May 20, we filed our Form 10-Q for the first quarter of 2021. The financial statements presented in that filing show a significantly improved balance sheet from December 31, 2020, and in fact, present the strongest position the Company has been in since inception. Most notably, we reported at the end of March:

  • $1.94 million in available cash, up from $8,300 at the end of 2020;
  • $389,000 of total current liabilities, down from $4.19 million at the end of 2020; and
  • $821,000 of Shareholder Equity, up from a Shareholder Deficit of $5.1 million at the end of 2020

The dramatic change in our cash and equity position resulted from the completion of our $2.5 million Series B Preferred Stock offering in January 2021, as well as the conversion to common stock of all Bridge Notes, which were previously in default, and additional common stock conversions of debentures and payables in the quarter. As of March 31, 2021, we only had $35,000 of debentures outstanding in addition to a Payroll Protection Program loan received in 2020 which we expect to be forgiven in future periods.

Please click on the above link to read the full press release

 

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 Company’s 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 tumor(s) 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.

Please click on the above link to read the full press release

 

QSAM Biosciences Issues Letter from CEO on Successful Achievements and Future Milestones for Company

Austin, TX, April 19, 2021 (GLOBE NEWSWIRE) — The Chief Executive Officer of QSAM Biosciences Inc. (OTCQB: QSAM), Douglas R. Baum, provided the following letter to shareholders:

Dear Shareholders:

We are pleased to report that 2020 was pivotal year for QSAM Biosciences as we established the foundation for significant advancements in 2021, several of which have already been achieved. We want to take this opportunity to summarize some of the more material items that we believe will help build value for our shareholders in the years ahead, and which are also detailed in our Form 10-K filed with the SEC on April 15, 2021.

During 2020 and the first quarter of 2021 we accomplished the following:

     Secured promising drug technology to treat bone cancer

     Established a team of seasoned biotech experts

     Completed $2.5 million in new equity funding

     Significantly reduced our debt and divested our legacy business

Building upon this solid foundation, through 2021 we expect to demonstrate advancements from the achievement of several important milestones, including:

  • Filing and ultimate clearance of our 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 our intellectual property portfolio with newly issued patents;

  • Possible acquisition of a second radiopharmaceutical asset to expand our product pipeline; and

  • Adding additional biotech expertise to our team

On April 15, we filed our Form 10-K for the year ended December 31, 2020. The financial statements included therein contain certain items that we would like to further explain, as we had several unusual transactions during the year. 

Please click on the above link to read the full press release

 

Palm Beach, FL, Jan. 21,2021 (GLOBE NEWSWIRE) — QSAM Biosciences, Inc. (OTCQB: QSAM), a company developing next generation nuclear medicines for the treatment of cancer and related diseases and conditions, announced today favorable results from a study to evaluate the radioactive impurity levels in its flagship drug candidate Samarium-153-DOTMP (aka CycloSam®). The results of this study are positive indicators about the safety profile and potential expanded uses of CycloSam if ultimately approved for commercial usage by the U.S. Food and Drug Administration (FDA).

The study, conducted by leading radiopharmaceutical research firm, IsoTherapeutics Group, LLC, confirmed that the long-lived radionuclidic impurities of Europium-154 (Eu-154) in CycloSam are decreased over 40-fold to nearly non-detectable levels from those reported for a similar radiopharmaceutical product previously approved by the FDA for commercial usage.

The findings also indicate significantly less buildup of these impurities, which enhances the clinical utility of CycloSam, potentially allowing safe, multiple dosing regimens, and possibly leading to broader therapeutic applications across multiple indications.

“We are very pleased with the results of this study as it confirms CycloSam’s superior safety profile for impurities and the integrity of our manufacturing procedures, stated Douglas R. Baum, CEO and Co-Founder of QSAM. 

 Click on the above link to read the full press release.

Palm Beach, FL, Dec. 10, 2020 (GLOBE NEWSWIRE) — QSAM Biosciences, Inc. (OTCQB: QSAM), a company developing next generation nuclear medicines, including Cyclosam® Samarium-153-DOTMP, for the treatment of cancer and related diseases and conditions, announced today that the European Patent Office (EPO) has allowed the first patent covering “DOTMP kit formulations for radioisotopes.”

This is the first patent outside the United States and is in addition to the two prior patents issued by the United States Patent & Trademark Office (USPTO) covering “High purity and low specific activity therapeutic bone agents.”

The EPO patent allowance covers technology licensed exclusively by QSAM from IGL Pharma, Inc. that protects the radiopharmacy preparation of CycloSam. The DOTMP kits, which refer to the chelating agent that binds the radioisotopes to growing cells in the bone and is believed by management to reduce toxicity and increase efficacy of the drug candidate, are a crucial component of the Cyclosam radiopharmaceutical product.

Click on the above link to read the full press release.

Pharmaceutical Industry Experts Assume Leadership Roles at QSAM;
Over $4M in Debt Eliminated from Balance Sheet

Palm Beach, FL, Nov. 10, 2020 (GLOBE NEWSWIRE) — QSAM Biosciences, Inc. (OTCQB: QSAM) announced today that it has signed an Omnibus Separation Agreement with Earth Property Holdings LLC (“EPH”) to provide for the termination of management services to EPH and the elimination of over $1.1 million in debt owed to EPH, among other terms.

In connection with this agreement, Kevin Bolin has stepped down as Chairman and CEO of the Company and has been replaced by Douglas Baum as CEO and C. Richard Piazza as Executive Chairman of the Board.

In separate transactions, the Company has also converted approximately $2.8 million in promissory notes previously in default, and approximately an additional $0.37 million in deferred compensation and other liabilities, into shares of common stock at a conversion price of $0.22 per share.

Click on the above link to read the full press release.

Palm Beach, FL, Oct. 09, 2020 (GLOBE NEWSWIRE) –QSAM Biosciences, Inc. announced today that it has commenced trading on The OTC Markets under the new stock symbol QSAM.

Last month QSAM announced its new name and business direction pursuing the development and commercialization of a clinical stage novel radiopharmaceutical called CycloSam® which is meant to treat different types of bone cancer and related diseases.

QSAM has worldwide, exclusive rights to this promising nuclear technology. CycloSam is expected to go into Phase 1 clinical trials in Q1 2021, and has already been used successfully in one human trial this past summer.

“This is another step forward in our corporate development, which should be matched over the next several months with important advancements preparing for human trials of CycloSam, and developing strategic partnerships that can help us on our mission to treat bone cancer,” stated Douglas Baum, a company Director and President and CEO of the company’s wholly subsidiary QSAM Therapeutics.

Click on the above link to read the full press release.

Key Investment Considerations:

  • Management: “You will not find a management team of this caliber in any other small cap company with a $12 million market cap.” (OTC Stock Review)
  • CycloSam® has already demonstrated safety and efficacy in animal studies and a human trial performed at the prestigious Cleveland Clinic and is cleared by the FDA under an investigator IND to commence human dosing immediately in patients with osteosarcoma and bone metastasis. 
  • Initial research has identified four initial potential indications for CycloSam®: Osteosarcoma (bone cancer); Metastatic Bone Cancers; Bone Marrow Ablation (removal); Lower Dose Radiation.
  • Executive Leadership and Advisory Team has extensive domain as well as FDA application/approval process experience.
  • QSAM shares are significantly undervalued compared to other companies in the FDA approval process. (Penny Stocks News)

Bottom Line Observation:

This is just the beginning of what looks like a ground floor opportunity for bio-tech/bio-science investors and a high upward movement in share price.

Interested investors definitely want to keep QSAM on their radar screens or even start building a position in the shares at what appears to be a nice entry point.

Research and Editorial Staff of MicroCap MarketPlace

_________________________________________________________________________

More about QSAM Biosciences, Inc. (OTCQB: QSAM)

QSAM Biosciences, Inc. (f/k/a) Q2Earth, 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​ 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%

February 2020 | Report Format: Electronic (PDF) 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.

__________________________________________________________________________

Disclaimer and Disclosures: MicroCap MarketPlace (MCMP) is a financial publisher and not a FINRA broker/dealer or investment adviser. MCMP is not registered with the SEC / U.S. Securities and Exchange Commission or any state securities regulatory agency. Readers, subscribers and web site visitors are responsible for individual investment decisions. All information contained in our newsletters or on our web site and in our blogs should be independently verified with the featured companies and readers should always conduct their own research and due diligence and engage professional investment advisers as they deem appropriate before making investment decisions. Please review the Terms and Conditions of Use, including without limitation all disclaimers of warranties and limitations on liability contained therein. Your use of any information on our websites, contained herein or in our newsletters and blogs constitutes your agreement of same. Officers, employees and affiliates may hold positions in the featured securities discussed in our newsletters or on our web site and blogs and may buy or sell said securities at any time without further notice. MCMP and/or affiliates may from time to time receive cash and/or equity compensation from featured companies for corporate marketing and communications services. In the interest of full disclosure, Mike Casson, MCMP’s Founder/Executive Editor is also president of Casson Communications, LLC (CCLLC) an affiliated company. CCLLC has received five thousand four hundred dollars in cash compensation from OTC Stock Review for marketing and communication services and allocated a portion of that compensation for the distribution of this article as part of said services. You should be aware of these potential conflicts of interest. We believe the information contained herein and in our publications to be reliable but cannot guarantee its accuracy; therefore, all information is provided as is without warranty of any kind. Past results are not necessarily indicative of future performance.

© 2021 MicroCap MarketPlace, All Rights Reserved