QSAM Biosciences, Inc.
(Note: This is NOT an IPO. This is a NASDAQ uplisting – a unit offering of stock and warrants – from the OTCQB Venture Market. QSAM Biosciences has applied to list its stock and warrants on the NASDAQ under the symbols “QSAM” and “QSAMW,” respectively.)
**Note: “In order to obtain NASDAQ listing approval, we conducted a 1-for-40 reverse split of our issued and outstanding common stock that was made effective by Financial Industry Regulatory Authority (“FINRA”) approval on March 10, 2022. A “D” has been placed on the QSAM Biosciences Inc. ticker symbol, QSAM, for 20 business days starting on March 10, 2022, to alert the public of the 1-for-40 reverse stock split effectuated on that day on OTC Markets.”
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.
Note: Revenue and net loss figures are for the year ended Dec. 31, 2021.
(Note: QSAM Biosciences, Inc., downsized its unit IPO in an S-1/A filing dated April 1, 2022: The number of units was trimmed to 1.71 million (1,714,286) units, down from 1.74 million (1,739,130) units previously, and the estimated IPO price was cut to $7.00 from $11.50 previously. The new estimated IPO price of $7.00 is the last reported sale price of our common stock on the OTCQB Venture Market on March 31, 2022 – as adjusted to reflect the 1-for-40 reverse stock split of our common stock. Under the new terms filed on April 1st, the estimated IPO proceeds are now $12 million, down from $20.01 million previously. This IPO had been expected to price on March 29, 2022.)
|Address||9442 Capital of Texas Hwy N, Plaza 1, Suite 500 Austin, TX 78759|
|Phone Number||512) 343-4558|
|View Prospectus:||QSAM Biosciences, Inc.|
|Revenues||$0 mil (last 12 months)|
|Net Income||$-11.98 mil (last 12 months)|
|Price range||$7.00 - $7.00|
|Est. $ Volume||$12.0 mil|
|Manager / Joint Managers||ThinkEquity|
|Expected To Trade:|
|Quiet Period Expiration Date:||Available only to Subscribers|
|Lock-Up Period Expiration Date:||Available only to Subscribers|
|SCOOP Rating||Available only to Subscribers|
|Rating Change||Available only to Subscribers|