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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.


GlobeNewswire Inc | Nov 16, 2021 09:58AM EST

November 16, 2021

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

-- Hosted a virtual science review to discuss the scientific rationale and evidence for PT00114 in the treatment of Depression, Anxiety, PTSD and Addiction. Replay available at www.protagenic.com. -- Hosted akey opinion leader (KOL) webinar focused on PT00114 for the regulation of stress in patients with Depression, PTSD, Anxiety and Addiction. Replay available at www.protagenic.com. -- Received FDA comment to provide clinical sites with ready-to-inject clinical vials of PT00114; to result in IND refiling in the fourth quarter

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.

AnticipatedUpcoming Milestones

-- Q4 2021:Re-filing of IND application for PT00114 -- Q12022:Initiation of Phase I/IIa study for PT00114 -- 2H2022:Initial Data Readout of Phase I/IIa study

FinancialResultsfortheSecondQuarterEndedSeptember 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 SubsidiaryBalance Sheet(In U.S. Dollars)(Unaudited)

September 30, December 31, 2021 2020ASSETS 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 441,435 1,081,384 discountPIK convertible notes payable, net of debt 120,654 292,412 discount - related parties 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 thefollowing classes:Preferred stock; par value $0.000001;2,000,000 shares authorized; none issued - - and outstandingSeries B convertible preferred stock,$0.000001 par value; 18,000,000 sharesauthorized; 0 and 872,766 shares issued and - 1 outstanding at September 30, 2021, andDecember 31, 2020 Common stock, $.0001 par value, 100,000,000shares authorized, 16,955,817 and 1,697 1,036 10,360,480 shares issued and outstanding atSeptember 30, 2021, and December 31, 2020Additional 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 $ 11,657,105 $ 879,247 (DEFICIT)

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

For the three months ended For the nine months ended September 30, September 30, 2021 2020 2021 2020 OPERATING ANDADMINISTRATIVE EXPENSESResearch and 257,279 539,770 990,222 657,737 developmentGeneral and 506,892 552,246 2,288,972 1,356,990 administrative TOTALOPERATING AND 764,171 1,092,016 3,279,194 2,014,727 ADMINISTRATIVEEXPENSES LOSS FROM (764,171 ) (1,092,016 ) (3,279,194 ) (2,014,727 )OPERATIONS OTHER(EXPENSE) INCOME Interest 336 17 568 494 incomeInterest (114,464 ) (58,827 ) (437,591 ) (152,757 )expenseChange in fairvalue of - 104,718 83,670 141,907 derivativeliability TOTAL OTHERINCOME (114,128 ) 45,908 (353,353 ) (10,356 )(EXPENSES) LOSS BEFORE (878,299 ) (1,046,108 ) (3,632,547 ) (2,025,083 )TAX INCOME TAX - - - - EXPENSE NET LOSS $ (878,299 ) $ (1,046,108 ) $ (3,632,547 ) $ (2,025,083 ) COMPREHENSIVE LOSS OtherComprehensive Loss - net oftaxNet unrealizedloss on (974 ) - (974 ) - marketablesecuritiesForeignexchange (791 ) 736 182 (599 )translationincome (loss) TOTALCOMPREHENSIVE $ (880,064 ) $ (1,045,372 ) $ (3,633,339 ) $ (2,025,682 )LOSS Net loss percommon share - $ (0.05 ) $ (0.10 ) $ (0.26 ) $ (0.20 )Basic andDiluted Weightedaverage common 16,521,882 10,275,758 13,939,400 10,274,005 shares - Basicand Diluted

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 Officer213-260-4342alex.arrow@protagenic.com

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







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