New Premium Alert For 1/30 - Next Gen Biotech Company $5/shr (FDA Clearance) Surge Ahead?

Breakout Alert: Saturday January 28, 2023 QSAM Biosciences (Ticker: QSAM) Developing Next Generation Radiopharmaceuticals For The Treatment of Cancer... Lightyears Ahead of the Pack! Hi 10XProTrader Member, This is Kevin Vander with “10XProTrader” delivering you your new premium alert for Monday 1/30 - trading session is QSAM Biosciences Inc. (QSAM) The Company has several bullish catalysts in the pipeline, and is on the verge of disrupting a $200 Billion Cancer Treatment Industry, with developing next-generation nuclear medicines for the treatment of cancer and related diseases! QSAM Biosciences is poised to emerge as a key player in bone cancer treatment and other related diseases and indications via its focus on the novel use of radiopharmaceutical therapy (RPT). There has been a significant surge in the use of radiopharmaceuticals for the diagnosis and treatment of chronic diseases, with the market expected to reach $9.6 Billion in 2026, up from about $4.8 Billion in 2018. The Company’s initial indication for CycloSam® is for osteosarcoma, a bone cancer afflicting 800-900 adolescents in the US each year. Current therapies are sub-optimal in terms of efficacy and quality of life (QoL). As evidenced by results from animal studies and an FDA-cleared Single Patient IND in 2020, , management believes it is in a good position to be awarded Orphan Drug Designation and qualify for an FDA Expedited Program for CycloSam® to be potentially used as a front-line therapy for pain palliation, tumor resolution and QoL. Key results of the trial include: - CycloSam® trafficked exactly as seen in multi-species animal models - CycloSam® targeted bone - primary tumor and metastasis visible - 50% of CycloSam® delivered to bone - CycloSam® delivered an ablative radiation dose to marrow as well as primary tumor and metastases - CycloSam® no unexpected adverse effects. Cleared major organs within hours. This nuclear technology uses low specific activity Samarium-153 (resulting in far less undesirable) and DOTMP, a novel chelant which is believed to eliminate off-target migration and targets sites of high bone turnover making it an ideal agent to treat osteosarcoma or other bone metastases. Due to its ability to deliver radiation directly to the skeletal system, it is also believed to be an effective agent to use in bone marrow ablation as pre-conditioning for bone marrow transplantation. CycloSam® Could Emerge As The Standard of Care Versus Current Therapies, Representing an Estimated $105 Million Market for Osteosarcoma and $1 Billion for Bone Marrow Ablation Additionally, Management Intends to Further the Clinical Development of CycloSam® As a Treatment for Metastatic Bone Cancer, Representing a $20 Billion Market The Company’s flagship product CycloSam® is a clinical stage bone-seeking radiopharmaceutical therapy designed to specifically and safely deliver targeted radiation therapy to kill cancer cells in and near the bone. In animal studies and a recent single patient human trial, this approach appears to improve efficacy and safety. Image by QSAM Biosciences Inc. via Corporate Presentation Q1 2023 Page 5 QSAM Biosciences Combines The Tumor Killing Power of Radiation With Cancer Seeking Agents QSAM Biosciences is developing next-generation nuclear medicines for the treatment of cancer and related diseases. QSAM’s initial technology, CycloSam® is a clinical-stage bone targeting radiopharmaceutical developed by IsoTherapeutics Group LLC, pioneers in the nuclear medicine space who also have developed other FDA-approved radiopharmaceutical products. QSAM is led by an experienced executive team and Board of Directors that have completed numerous FDA approvals and multiple successful biotech exits. Image by QSAM Biosciences Inc. via Corporate Presentation Q1 2023 Page 13 CycloSam® has demonstrated preliminary safety and efficacy in animal studies and a single patient FDA-cleared human trial performed in 2020 at the Cleveland Clinic. This nuclear technology uses low specific activity Samarium-153 (resulting in far less undesirable europium impurity) and DOTMP, a chelator which targets sites of high mineral turnover (bone) and is believed to reduce or eliminate off-target migration making it, in management’s opinion, an ideal agent to treat primary and secondary bone cancers. Improved Next Generation Therapeutic Over Prior FDA-approved Pharmaceutical Since CycloSam® delivers targeted radiation selectively to the skeletal system, it is also believed to be an important candidate for use in bone marrow ablation as pre-conditioning for bone marrow transplantation, and in procedures to reduce external beam radiation to bone tumors. This multi-patented drug candidate utilizes a radioisotope previously approved by the FDA, combined with a novel targeting chelant that has demonstrated preliminary increased efficacy and decreased side effects in animal models and veterinary treatment of bone cancer in dogs. Further, CycloSam® utilizes a streamlined, just-in-time manufacturing process that is well established. We believe that what we have accomplished to date demonstrates the experience of our management team in successfully and efficiently navigating drug candidates through the FDA process. QSAM Is Led By An Experienced Executive Team And Board Of Directors That Have Completed Numerous FDA Approvals And Multiple Successful Biotech Exits Image by QSAM Biosciences Inc. via Corporate Presentation Q1 2023 Page 14 Radio Pharmaceuticals Is A Key Primer For Rapid Growth For The Loyal QSAM Shareholders There has been a huge surge in the use of radiopharmaceuticals for the diagnosis and treatment of chronic diseases, with the market expected to reach $9.6 Billion in 2026, up from about $4.8 Billion in 2018. According to an article published in a July 2020 edition of Nature.com. “Radiopharmaceutical therapy (RPT) is defined by the delivery of radioactive atoms to tumor-associated targets. RPT is a novel therapeutic modality for the treatment of cancer, providing several advantages over existing therapeutic approaches." - Nuclear medicine imaging techniques and other advanced diagnostics to assess targeting of the agent offer a defined advantage over existing therapeutic approaches and enables a precision medicine approach to RPT delivery. Moreover, as compared with most cancer treatment options, RPT has shown efficacy with limited toxicity. In addition, unlike chemotherapy, responses with RPT agents typically do not require multiple cycles of therapy and are often observed after injections. - Another advantage RPT has is pre-use observation. Having imaging and treatment molecules that use the same target as that imaging can give doctors a preview of whether the treatment is likely to work. If an imaging compound administered beforehand in a PET scan finds its way to the cancer cells and is detected on the scan, then observers can assume that the corresponding radiopharmaceutical treatment will hit its target. - There is a history of successful M&A in the RPT arena. Bayer acquired Xofigo in 2009 for $800 Million followed by Algeta for $2.9 Billion n 2014. Xofigo is estimated to have enjoyed peak sales of $1.5 Billion, a historically significant deal in the industry. - Xofigo (radium Ra 223 dichloride) is used to treat prostate cancer that no longer responds to hormonal or surgical treatment that lowers testosterone. It is for men whose prostate cancer has spread to the bone and exhibit symptoms, but not to other parts of the body. Radium-223 traces its roots to 1905 and has been used for skeletal metastases. Unfortunately, since its decay is 95% alpha radiation, radium-223 is estimated to give targeted osteogenic cells a radiation dose several times higher than other non-targeted tissues. - Separately, Novartis acquired Endocyte and AAA in 2018 for $3.9 Billion. Interestingly, the lead drug, Lutathera®, was awarded FDA approval in 2018 for treatment of neuroendocrine tumors of the pancreas and small intestine. According to an NCI article. Image by QSAM Biosciences Inc. via Corporate Presentation Q1 2023 Page 26 Six Milestones That Help Shape The Tremendous Upside Potential for Shareholders - Received Rare Pediatric Disease Designation for CycloSam® for the treatment osteosarcoma, a devastating form of bone cancer that afflicts mostly children and young adults. This designation is in addition to the Orphan Drug Designation received in 2021 and may provide substantial financial incentives by making QSAM eligible for a transferrable and saleable Priority Review Voucher (PRV) upon drug approval by the FDA. - Dosed initial two patients in our Phase 1 clinical trial. The preliminary data we have collected demonstrate early signs of safety and efficacy. CycloSam performed in these two patients in the same manner observed in animal patients in that the drug and its highly targeted radiation was delivered to the bone at and around the site of tumors and the remainder of the drug product was then rapidly eliminated from the body. Further, both patients reported a significant reduction of pain, even months after the dosing. This is early data that may not be indicative of future results, but it is quite encouraging. - Established two clinical trial sites, including Rutgers Cancer Institute of New Jersey (RCINJ), part of Rutgers Health and New Jersey’s only National Cancer Institute (NCI) – designated Comprehensive Cancer Center , an elite recognition that is granted competitively to institutions based on their scientific leadership, resources, and outstanding track record of research discoveries and ability to translate these discoveries to benefit cancer patients. - Completed approximately $1.5 Mil in common stock and warrant funding to continue to advance our trials; and reduced our balance sheet liabilities by approximately $800,000 in the fourth quarter and ongoing overhead expenses by approximately $600,000 per year so that we can dedicate more resources to the clinical trials. Building upon these accomplishments, our goals for 2023 are clear and focused, primarily: - Complete our Phase 1 study , consisting of up to 17 patients , and commence our Phase 2 study which will include providing patients with multiple doses of CycloSam® over a four to six month regimen. We have preliminary data from prior investigators that demonstrates the efficacy in treating bone cancer when Samarium-153 is used on a repeated basis to bombard tumors (see the “Vienna Protocol” per FN1), and we seek to replicate relevant portions of that study starting in late 2023 with our newer version of this targeted cancer-therapy radioisotope. - Secure capital through an underwritten offering and concurrent NASDAQ uplisting to fund our clinical trials through Phase 2a, which we estimate to be approximately $12 - $15 Million. Such a transaction, which we attempted but suspended in early 2022 due to market conditions, could provide our QSAM shareholders with added liquidity, and with what we believe to be a more appropriate valuation given the strength of our asset and progress achieved in our clinical studies. The QSAM Difference From Its Competition QSAM is developing next generation nuclear medicines for the treatment of cancer and related diseases and conditions with high unmet need. The Company’s flagship product, Cyclosam®, is a clinical stage bone-seeking radiopharmaceutical therapy designed to specifically and safely deliver targeted radiation to kill cancer cells in and near the bone via a radioisotope. In animal studies and a recent single-patient human trial, this approach appears to improve efficacy and safety. QSAM plans to commence additional trials during 2021.With two issued patents in the US, one allowed patent in Europe and fourteen pending patents that protect the use of CycloSam®, QSAM is set to protect its most valuable resource and enable management to leverage its IP going forward. INITIAL TECNOLOGY: CYCLOSAM® CycloSam® is a bone-seeking therapy designed to deliver targeted radiation therapy specifically and safely in the form of the radioisotope Samarium-153 (Sm-153) to areas of bone formation by employing the bone-seeking chelant (a molecule that binds to positively charged metal ions) — DOTMP. Sm-153 emits beta and gamma radiation and kills nearby cancer cells. QSAM Therapeutics Inc, a wholly owned subsidiary of QSAM, holds the worldwide license to this clinical stage, novel radiopharmaceutical meant to treat different types of bone cancer and related diseases. This therapeutic was developed by IsoTherapeutics Group LLC, leaders in the nuclear medicine space. It should be noted that while working at The Dow Chemical Company the founders of IsoTherapeutics Group also developed FDA-approved and commercially available Quadramet® (Samarium-153 EDTMP), indicated for pain palliation. CycloSam® uses Sm-153 radioisotope like Quadramet®, an FDA-approved and commercially released drug, but due to the proposed improved chelant, efficacy and safety are expected to be significantly improved. Long-lived radionuclidic impurities found in Quadramet are significantly reduced. CycloSam® was assigned to IsoTherapeutics Group’s subsidiary, IGL Pharma, Inc., presently a partner to QSAM. CycloSam® has already demonstrated preliminary safety and efficacy in animal studies and a successful FDA-cleared single patient human trial performed earlier in 2020. This nuclear therapeutic 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. Due to its innate ability to deliver radiation to the skeletal system, it is also believed to be an effective agent to be used in 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 be used in bone marrow ablation prior to allogenic marrow transplantation (BMA/T) in 2020. Conclusion... QSAM is poised to emerge as a key player in bone cancer treatment and other related diseases and indications via its focus on the novel use of radiopharmaceutical therapy (RPT). RPT has significant advantages over existing therapies, such as chemotherapy and radiation. The RPT market is huge, and its adoption along with M&A are on the rise. The market is expected to reach $9.6 billion in 2026, up from about $4.8 billion in 2018. QSAM’s lead product is a clinical-stage bone seeking, cancer-killing therapy. This product features a specialized binding molecule designed to safely and specifically deliver targeted radiation therapy to kill cancer cells in and near the bone via a radioisotope. QSAM’s flagship represents multiple indications with a potential addressable market in the billions. Separately, QSAM is primed to be awarded Orphan Drug Status for its lead indication and possibly an expedited program status following strong studies and a single patient human trial. I urge you and all of my 10XCommunity to add QSAM to the very top of your watchlist for Monday. Additionally, stay on the look out for my next update via email & SMS coming out on QSAM. Yours for greater gains, Kevin Vander 10XProTrader.com Investment Research Sources: 1: 2: 3: 4: Leg∙al Entity Information: 10XProTrader is a website owned and operated by 10XPublishing, LLC., which is a DBA of 10XMedia, LLC. You are receiving this e-mail as part of your subscription to 10XProTrader. 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