Protagenic Therapeutics Announces Third Quarter 2021 Results and Business Update
Protagenic Therapeutics, Inc. (Nasdaq: PTIX) reported its Q3 2021 results, highlighting significant advancements in developing PT00114 for stress-related neurological disorders. The company hosted a virtual science review and KOL webinar, discussing PT00114's potential for treating depression, anxiety, PTSD, and addiction. Financially, net loss decreased to approximately $0.9 million from $1.0 million year-over-year, with R&D expenses also down at $0.3 million. The company holds $10.8 million in cash and plans to refile its IND application in Q4 2021, with a Phase I/IIa study set for Q1 2022.
- Decreased net loss from $1.0 million to $0.9 million year-over-year.
- Reduced research and development expenses from $0.5 million to $0.3 million.
- Received FDA comment for clinical trial readiness, facilitating IND refiling.
- Continued net loss of $0.9 million indicates ongoing financial challenges.
- Accumulated deficit rose to $21.3 million from $17.7 million year-over-year.
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 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 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, | ||||||||
| Preferred stock; par value | - | - | ||||||
| Series B convertible preferred stock, | - | 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
FAQ
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