Major Development For QSAM Biosciences Has Applied Their Common Stock on The NASDAQ
3/23/2022 Today's stock profile (Ticker Symbol: QSAMD) is currently witnessing a volume spike and is trending up. QSAMD is trading at approx $12/share as it's quickly gaining a lot of attention in the early trading hour. In a recent FORM S-1/A filed on March 10th, 2022 (QSAM) stated they have applied to list their common stock on the Nasdaq Capital Market ("NASDAQ") under the symbol "QSAM". This is an enormous catalyst for any stock, especially for a Biotech stock! Note: All of the information below comes directly from QSAM Biosciences FORM S1/A - Follow Link Here We are developing next-generation nuclear medicines for the treatment of cancer and related diseases. Our initial technology is Samarium-153 DOTMP, a/k/a CycloSam® ("CycloSam®" or the "New Technology"), a clinical-stage bone targeting radiopharmaceutical. CycloSam® features a patented, low specific activity form of Samarium-153, a beta-emitting radioisotope with a short 46-hour half-life, and the chelating agent DOTMP, which selectively targets sites of high bone mineral turnover and reduces off-site migration of the tumor-killing radiation. We believe improvements in formulation and manufacturing from a prior FDA-approved drug (Quadramet®) utilizing the same radioisotope has resulted in our drug candidate demonstrating significantly less impurities, lower costs and more frequent availability. Samarium-153 and DOTMP form a highly stable complex, which we believe, when used either as a monotherapy or in combination with other more widely used treatments such as external beam radiation, may demonstrate meaningful disease modifying results in primary and metastatic bone cancer. Ultimately, we may seek to further develop and commercialize CycloSam® for one or more market indications or license the technology to a larger pharmaceutical partner. In August 2021, the Food & Drug Administration (FDA) cleared our Investigational New Drug (IND) application to commence Phase 1 clinical trials for CycloSam® as a treatment for cancer that has metastasized to the bone from the lung, breast, prostate and other areas. We initiated this trial at our first site (Houston, TX) in November 2021, and we seek to commence dosing patients in this open-label, dose escalating study in the first quarter or early second quarter of 2022. Also in August 2021, the FDA granted Orphan Drug Designation for the use of CycloSam® to treat a primary bone cancer called osteosarcoma, a devastating disease that mostly affects children and young adults. Although patients with osteosarcoma or Ewing's sarcoma are eligible to participate in our initial Phase 1 trials, we anticipate filing an amended protocol to our current commercial IND application in 2022 to commence clinical trials specifically for these primary, pediatric bone cancers. In March 2020, CycloSam® was also utilized in a Single Patient Investigational New Drug for Emergency Use at the Cleveland Clinic. We believe the study we conducted at the Cleveland Clinic showed promising safety results in connection with a bone marrow ablation procedure, including patient tolerability at high dosages. To date, CycloSam® has completed animal studies in both small and large animals, including treating bone cancer in patient dogs at a university veterinary clinic.
Clinical trials, the drug approval process, and the marketing of drugs are intensively regulated in the United States and in all major foreign countries. In the United States, the FDA regulates drugs under the Federal Food, Drug, and Cosmetic Act ("FDCA"), and related regulations. Drugs are also subject to other federal, state, and local statutes and regulations. Failure to comply with the applicable U.S. regulatory requirements at any time during the product development process, approval process or after approval may subject an applicant to administrative or judicial sanctions. These sanctions could include the imposition by the FDA Institutional Review Board ("IRB") of a clinical hold on trials, the FDA's refusal to approve pending applications or supplements, withdrawal of an approval, warning letters, product recalls, product seizures, total or partial suspension of production or distribution, injunctions, fines, civil penalties or criminal prosecution. Any agency or judicial enforcement action could have a material adverse effect on us. Current Development Stage of CycloSam® for Target Indications. Our initial IND to commence Phase 1 clinical trials for CycloSam® as a treatment for cancer that has metastasized to the bone from the lung, breast, prostate and other areas has been cleared by the FDA, and we seek to commence dosing patients in the first quarter or early second quarter of 2022. Patients with primary bone cancer, such as osteosarcoma or Ewing's sarcoma, are eligible to participate in our initial Phase 1 trials; however, we anticipate filing an amended protocol to our current commercial IND application in 2022 to commence an additional clinical trial specifically for these primary, pediatric bone cancers. Our initial Phase 1 trial is an open label, dose escalating study of approximately 17 patients. Enrollment commenced in March 2022 and the Phase 1 trials are expected to continue over the following 12 to 24 months. | | What is CycloSam®.
CycloSam® is a targeted, bone seeking therapeutic radiopharmaceutical (or radiotherapeutic) that combines the beta-emitting radioisotope Samarium-153 (153Sm) with a chelating agent, DOTMP (1, 4, 7, 10-tetraazacyclododecane-1, 4, 7, 10-tetramethylenephosphonic acid). Samarium-153 is acquired from a nuclear reactor from a third party and the chelating agent is supplied in the form of kits. Chelating agents are organic compounds capable of linking together metal ions to form complex ring-like structures. This combination forms a stable complex which delivers a radioactive dose to sites of rapid bone mineral turnover such as bone cancers and tumors. CycloSam® has a physical half-life of 46 hours (radiation decreases by half in 46 hours) and emits both medium-energy beta particles that produce the therapeutic effect, and gamma photons that make it possible to take images of the skeleton and locate and characterize the size and nature of tumors. The use of radioisotopes to both diagnose and treat disease is called "theranostics" and is a rapidly growing area of medical discovery. | |
How CycloSam® Works
Mechanism of Action & Administration. CycloSam® utilizes a chelating agent called DOTMP that seeks out bone locations of high mineral turnover, typically near cancer cells and tumor growth. The DOTMP part of the molecule is taken up by calcium turnover locations in bones and carries the radioactive "payload" along with it. The radioisotope Samarium-153 emits radiation as it decomposes in the form of beta particles. Approximately 50% of the radioactivity concentrates in bone mineral with a very high lesion-to-normal bone ratio. We believe this provides a radiation dose to the adjacent tumor cells. The absorbed radiation dose produces the presumed therapeutic effect to the tumor, killing the cancer cells or slowing their growth by damaging their DNA. Our pre-clinical studies and single patient IND performed at the Cleveland Clinic demonstrates that the remaining half of the administered activity is rapidly excreted through the kidneys.
Generally, radiation therapy does not immediately kill cancer cells and more than one treatment is expected to eradicate a tumor, dramatically reduce its size, or slow its growth. CycloSam® has a short half-life of 46 hours and is rapidly eliminated from the body. This avoids an undesirable radioactive buildup in healthy tissues and organs when used in multiple treatments, which we believe, is an important feature of CycloSam® over predecessor drugs. CycloSam® has also not demonstrated saturation of the bone sites in animal studies, which supports a multi-dosage treatment regimen. Additionally, we believe that high dosages may be administered for ablating the marrow in patients that may require procedures such as stem cell transplants.
The final drug product of CycloSam® is prepared from DOTMP kits and 153SmCl in 0.1 N HCl at a nuclear pharmacy local to the patient administration site. The final drug product is then delivered to the physician for use as an intravenous (IV) injection within 72 hours.
What are CycloSam®'s anticipated competitive advantages. We believe CycloSam® has competitive advantages over current radiopharmaceutical offerings in the marketplace. Such potential competitive advantages include:
● CycloSam®'s radioisotope, Samarium-153, emits beta particles that travel farther than alpha particles with what we believe is sufficient energy to slow the growth or decrease the size of target cancer cells. We believe beta particles penetrate bone matter deeper than the alpha emitting radiopharmaceuticals currently in the marketplace and may be more effective in treating tumors that form in or metastasize to bones. ● CycloSam®'s delivery agent, DOTMP, compared to other chelating agents such as EDTMP used in Quadramet®, has shown in animal and other pre-clinical testing to have a high bone binding affinity allowing for the maximum delivery of the radioactive "payload" adjacent to the tumor without saturation of the bone, as observed from our pre-clinical trials. ● Our method of manufacturing Samarium-153 compared to Quadramet®, has shown in our pharmacopeial limits studies to produce a 30-fold reduction in levels of the long-lived radioactive impurity, Europium-154. We believe this may mitigate toxicity issues with the patient. ● Our initial studies show CycloSam® has fewer toxicities and a short 46 hour half-life that may allow for more frequent and repeated dosing of our radiopharmaceutical. We believe this may have a greater ability to slow or reverse tumor growth. ● We believe we have in place an efficient and cost-effective manufacturing process and established distribution system that may in the future allow for 24/7 availability and enable the clinician to order and have the treatment delivered to the patient within approximately 72 hours.
The competitive advantages we believe to be important to CycloSam® are based on pre-clinical animal and other studies including our single patient IND performed at the Cleveland Clinic. We cannot be sure that our technology will perform similarly in clinical trials with multiple human patients. Failure to achieve these competitive advantages could negatively affect our ability to achieve FDA approval as a new drug, or our ability to market CycloSam® as a treatment for bone cancer.
Radiopharmaceuticals and Market Growth
Radiation is one of the most widely used treatments for cancer, with approximately 50% of all cancer patients receiving radiation therapy during their course of treatment [Source: Baskar R, Lee KA, Yeo R, Yeoh KW. Cancer and Radiation Therapy: Current Advances and Future Directions. Int J Med Sci 2012; 9(3):193-199. doi:10.7150/ijms.3635]. A major limitation of some forms of radiation treatments, such as external beam therapy, is that radiation cannot be delivered with enough precision to prevent collateral damage to healthy tissue. Radiopharmaceuticals seek to overcome these limitations by delivering the tumor-killing power of radiation directly to tumor cells while sparing healthy tissue. This also expands the potential therapeutic benefit to a broader array of cancer type and stages, including metastatic disease.
To create radiopharmaceuticals, radiation emitting medical isotopes are typically attached to targeting molecules and administered via intravenous injection. Once administered, the radiopharmaceuticals selectively target tumor characteristics that are unique to, or preferentially expressed on, cancer cells. In the case of CycloSam®, we attach Samarium-153 to a chelating agent called DOTMP. This chelator seeks out and targets sites of high bone mineral turnover adjacent to cancer cells that have formed in or metastasized to the bone.
The radiopharmaceutical market is projected to reach $13.8 Billion by 2028 from $7.6 Billion in 2021, according to a published study by The Insight Partners: "Radiopharmaceuticals Market to 2028 – Global Analysis and Forecast – by Type, Product Type, Application, and End User." North America dominates the global radiopharmaceuticals market, which is attributed to the prevalence of chronic disorders and the presence of supportive government plans for the development of research regarding radiopharmaceuticals. Based on type, the radiopharmaceuticals market is bifurcated into diagnostic nuclear medicine and therapeutic nuclear medicine. By application, the market is segmented into oncology, cardiology, neurology, and others, with the oncology segment holding the largest market share in 2021.
Another study published in 2019 in Radiotherapeutics and Radiodiagnostics shows similar growth, but with therapeutics experiencing the highest CAGR from 2020 to 2025, and the overall market reaching over $13.8 Billion by 2025:
Potential Market Indications for CycloSam®.
CycloSam's therapeutic profile and presumed advantages over other radiopharmaceuticals, including Quadramet, translate to several potential key market indications as detailed in the following table: | | Recent Major Developments
1.) In connection with our application to list our shares of common stock on NASDAQ and to meet initial listing qualifications required by NASDAQ, on December 17, 2021, our board of directors approved via unanimous written consent a reverse stock split of outstanding shares of our common stock in the range of 1:2 to 1:40. On January 6, 2022, our stockholders holding 58.5% of the Company's voting stock, voting on as-converted basis took action by written consent to approve the same, and authorized the board to determine the exact ratio of split at its discretion in connection with the Company's uplisting to a national securities exchange. On February 22, 2022, our board through a unanimous written consent set the reverse stock split ratio at 1:40. Subsequently, we filed an amendment to our amended and restated certificate of incorporation with the Secretary of State of the State of Delaware on March 4, 2022 to effectuate the reverse stock split as of March 9, 2022. Further, FINRA approved the reverse stock split pursuant to Rule 6490 effective March 10, 2022. All share numbers in this Prospectus have been adjusted to account for this reverse split.
2.) On January 24, 2022, we appointed Adriann Sax as an independent member of our board of directors. Ms. Sax has a 30+ year career in biotech and life sciences, most recently serving as CEO and co-founder of Vetigenics LLC, an animal health biotech company, and earlier in her career as Entrepreneur in Residence at Fortress Biotech, Vice President at Bristol Myers Squibb, Executive Director at Merck & Co., and Executive Vice President in charge of Business Development and Strategic Planning at King Pharmaceuticals, leading to its acquisition by Pfizer.
3.) On March 3, 2022, Jeffrey M. Soinski agreed to join as an independent member of our board of directors and to chair our audit committee, effective immediately prior to the completion of this offering and listing on NASDAQ. Mr. Soinski has 30 years of experience building operating companies in diverse healthcare segments, including his current role as President and CEO and a member of the board of directors of Avinger, Inc., (NASDAQ: AVGR), a developer and manufacturer of proprietary image-guided medical devices for the treatment of vascular disease. Earlier in his career, Mr. Soinki has served in several executive positions within medicine and healthcare industry as well as in venture capital and investment banking.
4.) On March 3, 2022, we appointed Adam King to serve as our Chief Financial Officer. Since December 6, 2021, Mr. King served as Interim CFO for the Company. Mr. King is the founder and CEO of King Consulting Group, where he provides a range of financial and reporting services for clients that range from large private equity-backed international companies to small start-ups. Earlier in his career, Mr. King was Office Managing Audit Director at the national accounting firm BDO, Director of Revenue Assurance and Internal Controls at Bandwidth.com, and Audit Manager at Ernst & Young.
5.) On March 4, 2022, Christopher Nelson and Joel Mayersohn both resigned from our board. Both Messrs. Nelson and Mayersohn have served on our board since 2015. Mr. Mayersohn served on our audit and compensation committees at the time of his resignation. Their departure from the board was effected to provide open seats to new independent directors in contemplation of the Company's listing on, and pursuant to the board independence requirements of, NASDAQ. Mr. Nelson will remain General Counsel of the Company.
6.) As of March 9, 2022, the Company has reached agreements with all Series A Preferred Stock and Series B Preferred Stock holders to convert their respective shares of preferred stock into common stock, effective immediately prior to the closing of this offering. Our issued and outstanding shares of common stock disclosed in this Prospectus reflect these conversions.
7.) On March 8, 2022, the Company signed an extension to its Exclusive Option Agreement with IsoTherapeutics Group, LLC – inventors of the Company's CycloSam® technology -- to allow the Company period of time through June 30, 2022 to perform diligence and potentially negotiate a worldwide, exclusive license agreement for a pre-clinical stage radiochemical therapy called BetaBrachTM. BetaBrach is a brachytherapy, a cancer treatment where radioactive implants are inserted directly into diseased tissue to eradicate the target tumor. BetaBrach uses beta radiation (Yyttrium-90) chemically formulated to significantly reduce migration.
Ticker Symbol: QSAMD |
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