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

Progress Shown in Phase 1 Clinical Program Evaluating CycloSam® Radiopharmaceutical Drug Candidate for Treatment of Metastatic Bone Cancer

AUSTIN, Texas, Aug. 16, 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 second quarter ended June 30, 2022, as filed with the SEC on August 15, 2022 in the Company’s Form 10-Q, and provides a corporate update.

Recent Corporate Highlights:

  • Initial, preliminary evaluation of the first patient dosed in Phase 1 clinical trial for CycloSam® for the treatment of metastatic bone cancer suggests promising results.
  • Second patient dosing and completion of the first cohort of patients in the trial is expected in the third calendar quarter.
  • Additional clinical trial sites for CycloSam® and additional nuclear reactor sites expected to be added in the third calendar quarter.
  • Third key patent received in the United States covering the production and delivery of CycloSam®, strengthening Company’s extensive patent portfolio.

“We are encouraged by the initial, preliminary data from the first patient dosed with CycloSam®. While it is too early for formal conclusions to be made of these early results, we did see positive signals in terms of safety and efficacy. CycloSam performed how we expected it to perform, even given the lowest dosage in our dose-escalating study. Over the next few months, we expect to make steady progress in our first clinical trial, including establishing additional trial sites that will help us treat more patients, and qualifying additional nuclear reactors to build redundancy and efficiencies in our supply chain,” stated Douglas R. Baum, CEO and co-founder of the Company.

“Our decision to postpone our planned equity raise and NASDAQ uplisting in May was based on market conditions at that time. We are now seeing the beginnings of a turn-around in the broader biotech markets. If these continue, and we achieve the progress we expect in our clinical trials over the next six months, we intend to revisit the uplisting process in early 2023. We are actively working 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 June 30, 2022:
(All numbers except shares are approximated)

Net loss attributable to common stockholders for the quarter ended June 30, 2022, was $1.33 million, compared to $3.07 million for the quarter ended June 30, 2021, a decrease of 57%.

Operating expenses were $1.26 million for the three months ended June 30, 2022, as compared to $2.90 million for the three months ended June 30, 2021. The $1.64 million decrease in operating expenses was largely due to a decrease in compensation and related expenses of $1.76 million in the three months ended June 30, 2022, which is comprised of $2.44 million of expenses from the vesting of Series E-1 Stock in the 2021 period as compared to $0.22 million of expenses from Series E-1 Stock vesting in the 2022 period, plus stock option compensation of $0.21 million and deferred management compensation of $0.24 million from an agreement with management to take reduced salaries in the 2022 period. In the second quarter of 2022, we also had an increase in professional fees of $0.07 million related to our terminated public offering, and an increase in research and development expense of $0.06 million related to our clinical trials, over the previous year period.

As of June 30, 2022, the Company had cash of approximately $0.43 million. The Company believes this is sufficient capital to support operations at the current pace into the third quarter of 2022. The Company expects to raise additional capital through equity or debt offerings in 2022 to support its clinical trials and other operating expenses.

As of June 30, 2022, the Company had 1,686,587 common shares outstanding. The Company did not issue any shares or options in the quarter. At the end of the second quarter of 2022 there were approximately 497,594 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 June 30, 2022, filed with the SEC on August 15, 2022, including the financial footnotes contained therein:


    June 30,     December 31,  
    2022     2021  
CURRENT ASSETS                
Cash   $ 429,353     $ 1,499,866  
Prepaid expenses and other current assets     108,221       135,014  
Deferred offering costs     -       35,000  
TOTAL CURRENT ASSETS     537,574       1,669,880  
TOTAL ASSETS   $ 537,574     $ 1,669,880  
Accounts payable and accrued expenses   $ 994,464     $ 569,321  
Accrued payroll and related expenses     588,805       95,400  
Accrued Series B preferred stock dividends     228,584       153,343  
Convertible notes payable, net of discount     550,550       532,400  
Notes payable - related parties     7,500       7,500  
Debentures     -       35,000  
TOTAL CURRENT LIABILITIES     2,369,903       1,392,964  
TOTAL LIABILITIES     2,369,903       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 $706,800 and $693,580) as of June 30, 2022 and December 31, 2021     706,800       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 June 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 June 30, 2022 and December 31, 2021     -       -  
Common stock, $0.0001 par value, 300,000,000 shares authorized, 1,686,587 and 1,652,102 shares issued and outstanding as of June 30, 2022 and December 31, 2021, respectively     169       165  
Unearned deferred compensation     (472,292 )     (900,742 )
Additional paid-in capital     30,327,583       29,765,585  
Accumulated deficit     (32,394,591 )     (29,281,674 )
TOTAL STOCKHOLDERS’ DEFICIT     (2,539,129 )     (416,664 )


    For the three months ended     For the six months ended  
    June 30,     June 30,  
    2022     2021     2022     2021  
REVENUES   $ -     $ -     $ -     $ -  
OPERATING EXPENSES                                
Payroll and related expenses     791,721       2,552,199       1,548,120       5,015,020  
Professional fees     218,006       151,858       857,411       954,686  
General and administrative     49,300       51,794       168,768       46,048  
Research and development expenses     204,216       147,453       459,053       221,407  
Total Operating Expenses     1,263,243       2,903,304       3,033,352       6,237,161  
LOSS FROM OPERATIONS     (1,263,243 )     (2,903,304 )     (3,033,352 )     (6,237,161 )
OTHER INCOME (EXPENSE)                                
Financing costs including interest     (20,203 )     (899 )     (38,340 )     (38,528 )
Gain on sale of equity method investment     -       -       -       100,000  
Loss on debentures and accrued expenses converted to common stock     -       -       -       (390,068 )
Loss on conversion of bridge notes and accrued interest     -       -       -       (744,505 )
Total Other Expense, net     (20,203 )     (899 )     (38,340 )     (1,073,101 )