Protagenic Therapeutics Announces Third Quarter 2021 Results and Business Update


NEW YORK, Nov. 16, 2021 (GLOBE NEWSWIRE) -- Protagenic Therapeutics, Inc. (Nasdaq: PTIX) a biopharmaceutical company focused on developing therapies to treat stress-related neurologic disorders, today announced results for the third quarter ended September 30, 2021.

Recent Highlights

“During the third quarter and year to date, we made significant progress towards moving PT00114 into the clinic, in order to treat stress-related neuropsychiatric disorders which afflict a growing patient population,” said Dr. Garo Armen, Executive Chairman of Protagenic Therapeutics. “We have a well-defined clinical path targeting psychiatric disorders like depression, anxiety, PTSD, and drug & alcohol addiction. We anticipate gathering efficacy and safety data readouts in the second half of 2022.”

Anticipated Upcoming Milestones

  • Q4 2021: Re-filing of IND application for PT00114
  • Q1 2022: Initiation of Phase I/IIa study for PT00114
  • 2H 2022: Initial Data Readout of Phase I/IIa study

Financial Results for the Second Quarter Ended September 30, 2021:

  • Net loss attributable to common stockholders for the quarter ended September 30, 2021 was approximately $0.9 million, compared to approximately $1.0 million for the quarter ended September 30, 2020.
  • Research and development expense totaled approximately $0.3 million for the quarter ended September 30, 2021, compared to approximately $0.5 million during the quarter ended September 30, 2020.
  • General and administrative expense was approximately $0.5 million for the quarter ended September 30, 2021, compared to approximately $0.6 million during the quarter ended September 30, 2020.
  • As of September 30, 2021, the Company had cash and cash equivalents of approximately $10.8 million.
  • As of November 15, 2021, the Company had approximately 17.0 million common shares outstanding.

Select Financial Information

Protagenic Therapeutics, Inc., and Subsidiary
Balance Sheet
(In U.S. Dollars)
(Unaudited)

  September 30, 2021  December 31, 2020 
ASSETS        
         
CURRENT ASSETS        
         
Cash $460,115  $671,091 
Marketable securities  10,394,573   - 
Prepaid expenses  802,417   208,156 
         
TOTAL CURRENT ASSETS  11,657,105   879,247 
         
TOTAL ASSETS $11,657,105  $879,247 
         
LIABILITIES AND STOCKHOLDERS’ EQUITY (DEFICIT)        
         
CURRENT LIABILITIES        
         
Accounts payable and accrued expenses $724,417  $571,517 
Derivative liability  -   83,670 
         
TOTAL CURRENT LIABILITIES  724,417   655,187 
         
PIK convertible notes payable, net of debt discount  441,435   1,081,384 
PIK convertible notes payable, net of debt discount - related parties  120,654   292,412 
         
TOTAL LIABILITIES  1,286,506   2,028,983 
         
STOCKHOLDERS’ EQUITY (DEFICIT)        
Preferred stock, $0.000001 par value; 20,000,000 shares authorized; 872,766 shares issued and outstanding in the following classes:        
Preferred stock; par value $0.000001; 2,000,000 shares authorized; none issued and outstanding  -   - 
Series B convertible preferred stock, $0.000001 par value; 18,000,000 shares authorized; 0 and 872,766 shares issued and outstanding at September 30, 2021, and December 31, 2020  -   1 
         
Common stock, $.0001 par value, 100,000,000 shares authorized, 16,955,817 and 10,360,480 shares issued and outstanding at September 30, 2021, and December 31, 2020  1,697   1,036 
Additional paid-in-capital  31,872,763   16,719,749 
Accumulated deficit  (21,331,483)  (17,698,936)
Accumulated other comprehensive loss  (172,378)  (171,586)
         
TOTAL STOCKHOLDERS’ EQUITY (DEFICIT)  10,370,599   (1,149,736)
         
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY (DEFICIT) $11,657,105  $879,247 


Consolidated Statements of Operations
(In U.S. Dollars)
(Unaudited)

  For the three months ended
September 30,
  For the nine months ended
September 30,
 
  2021  2020  2021  2020 
OPERATING AND ADMINISTRATIVE EXPENSES                
Research and development  257,279   539,770   990,222   657,737 
General and administrative  506,892   552,246   2,288,972   1,356,990 
                 
TOTAL OPERATING AND ADMINISTRATIVE EXPENSES  764,171   1,092,016   3,279,194   2,014,727 
                 
LOSS FROM OPERATIONS  (764,171)  (1,092,016)  (3,279,194)  (2,014,727)
                 
OTHER (EXPENSE) INCOME                
                 
Interest income  336   17   568   494 
Interest expense  (114,464)  (58,827)  (437,591)  (152,757)
Change in fair value of derivative liability  -   104,718   83,670   141,907 
                 
TOTAL OTHER INCOME (EXPENSES)  (114,128)  45,908   (353,353)  (10,356)
                 
LOSS BEFORE TAX  (878,299)  (1,046,108)  (3,632,547)  (2,025,083)
                 
INCOME TAX EXPENSE  -   -   -   - 
                 
NET LOSS $(878,299) $(1,046,108) $(3,632,547) $(2,025,083)
                 
COMPREHENSIVE LOSS                
                 
Other Comprehensive Loss - net of tax                
Net unrealized loss on marketable securities  (974)  -   (974)  - 
Foreign exchange translation income (loss)  (791)  736   182   (599)
                 
TOTAL COMPREHENSIVE LOSS $(880,064) $(1,045,372) $(3,633,339) $(2,025,682)
                 
Net loss per common share - Basic and Diluted $(0.05) $(0.10) $(0.26) $(0.20)
                 
Weighted average common shares - Basic and Diluted  16,521,882   10,275,758   13,939,400   10,274,005 

See accompanying notes to these unaudited consolidated financial statements in our Form 10-Q filed with the SEC November 15, 2021

About Protagenic Therapeutics, Inc.

Protagenic Therapeutics, Inc. (Nasdaq: PTIX) is a pre-clinical biopharmaceutical company endeavoring to develop first-in-class neuro-active peptides into human therapeutics to treat several stress related disorders. For more information, visit http://www.protagenic.com.

Forward-Looking Statements

This press release contains forward-looking statements that are made pursuant to the safe harbor provisions of the federal securities laws, including statements regarding Protagenic Therapeutics’ product candidates and pre-clinical development and clinical trial plans and activities. Forward-looking statements include words such as "expects," "anticipates," "intends," "plans," "could," "believes," "estimates" and similar expressions. These forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially. These risks and uncertainties include, among others, our ability to obtain additional capital to meet our liquidity needs on acceptable terms, or at all, including the additional capital which will be necessary to complete the pre-clinical testing and eventual clinical trials of our product candidates; our ability to successfully complete research and further development and commercialization of our product candidates; the uncertainties inherent in pre-clinical and clinical testing; the timing, cost and uncertainty of obtaining regulatory approvals; our ability to protect the Company's intellectual property; the loss of any executive officers or key personnel or consultants; competition; changes in the regulatory landscape or the imposition of regulations that affect the Company's products; and the other factors described under the Risk Factors section of our most recent Annual Report on Form 10-K filed with the Securities and Exchange Commission.. Protagenic Therapeutics cautions investors not to place considerable reliance on the forward-looking statements contained in this release. These statements speak only as of the date of this press release, and Protagenic undertakes no obligation to update or revise the statements, other than to the extent required by law. All forward-looking statements are expressly qualified in their entirety by this cautionary statement.

Analyst Contact:
Alexander K. Arrow, MD, CFA
Chief Financial Officer
213-260-4342
alex.arrow@protagenic.com

Media Contact:
James Carbonara
Hayden IR
(646)-755-7412
james@haydenir.com