QSAM Biosciences Reports Third Quarter 2022 Financial Results and Provides Corporate Update

Further Progress Demonstrated in Clinical Program Evaluating CycloSam® Radiopharmaceutical Drug Candidate for Treatment of Metastatic Bone Cancer

AUSTIN, Texas, Nov. 15, 2022 (GLOBE NEWSWIRE) -- QSAM Biosciences Inc. (OTCQB: QSAM), a company developing next-generation therapeutic radiopharmaceuticals, including Samarium-153-DOTMP (CycloSam®), for the treatment of bone cancer and related diseases, today announces financial results for the third quarter ended September 30, 2022, as filed with the SEC on November 14, 2022 in the Company’s Form 10-Q, and provides a corporate update.

Recent Corporate Highlights:

Second patient dosed in Phase 1 clinical trial; data continues to demonstrate preliminary positive results.  Completion of the initial cohort grouping of patients is expected in the fourth calendar quarter. 
Rutgers Cancer Institute of New Jersey (RCINJ) has been added as a clinical trial site to begin enrolling patients; expected to help accelerate pace of study and add key expertise. 
Approximately $1 million was raised in a common stock / warrant private placement during third quarter.

“Initial, preliminary data from our second patient dosed with CycloSam® continues to show positive signals in terms of safety and efficacy. While it is too early for formal conclusions to be made of these results, CycloSam generally performed how we expected it to perform, even given the lowest dosage in our dose-escalating study. This is all very encouraging,” stated Douglas R. Baum, CEO and co-founder of the Company.

“We expect the pace of our clinical trials to accelerate in the fourth quarter of 2022 and into 2023. This is partly due to the onboarding as a trial site the highly-regarded Rutgers Cancer Institute of New Jersey, which is a National Cancer Institute (NCI) – designated Comprehensive Cancer Center that treats a significant population of patients who could potentially qualify for our study. We have also been able to raise equity funding on favorable terms from supportive investors who share our long-term vision for QSAM. Our team continues to work towards creating shareholder value in conjunction with our most important mission to help adult and pediatric patients suffering from bone cancer,” added Baum.

Summary Financial Results for the Quarter Ended September 30, 2022:
(All numbers except shares are approximated)

For the three months ended September 30, 2022, we recorded a net loss of $1.23 million, an increase of $0.18 million from our net loss of $1.05 million for the same period in 2021. Our operating expenses were $1.21 million for the third quarter of 2022 as compared to $1.20 million in the 2021 period. The slight increase in operating expenses was largely due to an increase in compensation and related expenses of $0.23 million, an increase in research and development expenses of $0.08 million, and an increase in general and administrative expenses of $0.07 million, offset by a decrease in professional fees of $0.36 million in the three months ended September 30, 2022.

Net loss attributable to common stockholders for the third quarter of 2022 was $1.28 million as compared to $1.92 million for the 2021 period. The net loss attributed to common stockholders includes Series A and Series B preferred contractual dividends and deemed dividends. The net loss attributable to common stockholders, basic and diluted, for the three months ended September 30, 2022 was a loss of $0.75 per share as compared to a loss of $2.45 per share for the 2021 period.

As of September 30, 2022, we had cash on hand of $899,290, primarily from the closing of the first tranche of a common stock and warrant private placement.

As of November 10, 2022, the Company had 1,922,142 common shares outstanding, which includes the issuance of 205,556 shares in the quarter in connection with a private placement and 30,000 shares for a services contract. At the end of the second quarter of 2022 there were approximately 705,419 shares of common stock that could be issued upon the conversion of preferred stock, warrants and convertible debt, excluding employee stock options.

The following tables summarize our results of operations for the periods indicated, and are qualified in their entirety by the Company’s Form 10-Q for the period ended September 30, 2022, filed with the SEC on November 14, 2022, including the financial footnotes contained therein:


    September 30,     December 31,  
    2022     2021  
CURRENT ASSETS                
Cash   $ 899,290     $ 1,499,866  
Prepaid expenses and other current assets     66,159       135,014  
Deferred offering costs     -       35,000  
TOTAL CURRENT ASSETS     965,449       1,669,880  
TOTAL ASSETS   $ 965,449     $ 1,669,880  
Accounts payable and accrued expenses   $ 1,020,650     $ 569,321  
Accrued payroll and related expenses     810,454       95,400  
Accrued Series B preferred stock dividends     266,619       153,343  
Convertible notes payable, net of discount     559,625       532,400  
Notes payable - related parties     7,500       7,500  
Debentures     -       35,000  
TOTAL CURRENT LIABILITIES     2,664,848       1,392,964  
TOTAL LIABILITIES     2,664,848       1,392,964  
Redeemable convertible preferred stock - Series A; $0.0001 par value, 1,500 designated Series A, and 480 shares issued and outstanding (liquidation preference of $714,000 and $693,580) as of September 30, 2022 and December 31, 2021     714,000       693,580  
Preferred stock, Series B, $0.001 par value; 2,500 shares authorized, 1,509 shares issued and outstanding (liquidation preference of $1,737,585 and $1,662,757) as of September 30, 2022 and December 31, 2021     2       2  
Preferred stock, Series E-1, $0.0001 par value; 8,500 shares authorized, 0 shares issued and outstanding as of September 30, 2022 and December 31, 2021     -       -  
Common stock, $0.0001 par value, 300,000,000 shares authorized, 1,922,142 and 1,652,102 shares issued and outstanding as of September 30, 2022 and December 31, 2021, respectively     193       165  
Unearned deferred compensation     (348,548 )     (900,742 )
Additional paid-in capital     31,563,286       29,765,585  
Accumulated deficit     (33,628,332 )     (29,281,674 )
TOTAL STOCKHOLDERS’ DEFICIT     (2,413,399 )     (416,664 )



    For the three months ended     For the nine months ended  
    September 30,     September 30,  
    2022     2021     2022     2021  
REVENUES   $ -     $ -     $ -     $ -  
OPERATING EXPENSES                                
Payroll and related expenses     773,387       540,450       2,321,508       5,555,471  
Professional fees     108,841       473,017       966,251       1,427,703  
General and administrative     86,916       18,839       255,687       64,887  
Research and development expenses     245,853       164,378       704,902       385,785  
Total Operating Expenses     1,214,997       1,196,684       4,248,348       7,433,846  
LOSS FROM OPERATIONS     (1,214,997 )     (1,196,684 )     (4,248,348 )     (7,433,846 )
OTHER INCOME (EXPENSE)                                
Financing costs including interest     (18,744 )     (450 )     (57,084 )     (38,978 )
Gain on sale of equity method investment     -       -       -       100,000  
Loss on debentures and accrued expenses converted to common stock     -       -       -       (390,068 )
Gain on forgiveness of debt from Paycheck Protection Program     -       142,942       -       142,942  
Loss on conversion of bridge notes and accrued interest     -       -       -       (744,505 )
Total Other Expense, net     (18,744 )     (142,492 )