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Protagenic Therapeutics Announces Third Quarter 2021 Results and Business Update

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  • PTIX

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


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