Protagenic Therapeutics Announces Third Quarter 2021 Results and Business Update

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 a key 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.”

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 SubsidiaryBalance 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 endedSeptember 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 [e-mail]

Media Contact:James CarbonaraHayden IR(646)[e-mail]