Protagenic Therapeutics Reports Fourth Quarter and Full Year 2023 Results
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Insights
The transition of Protagenic Therapeutics from a pre-clinical to a clinical-stage company is a pivotal development. This transition often signals a material advancement in a biotech company's life cycle and can have a significant impact on its valuation. The initiation of Phase 1/2a trials is a critical step in drug development, as it marks the first time a drug candidate is tested in humans. The success of these trials is essential for the company to proceed to later stages of clinical development and eventually seek regulatory approval.
Investors often view the progression of a drug candidate into clinical trials positively, as it reduces the uncertainty surrounding the company's research and development efforts. However, the risks associated with clinical trials are high and the majority of drug candidates fail to make it past this stage. The focus on stress-related neuropsychiatric disorders, such as Treatment-Resistant Depression and PTSD, targets a market with a high unmet need, potentially offering a substantial opportunity if the drug proves to be safe and effective.
Entering the clinical trial phase for PT00114 positions Protagenic Therapeutics in a competitive segment of the healthcare market that is increasingly receiving attention due to the rising prevalence of mental health disorders. The potential addressable market for Treatment-Resistant Depression, PTSD, Generalized Anxiety Disorder and Addiction withdrawal is significant and a successful treatment could disrupt the current market, which is characterized by limited effective options.
From a market perspective, the successful development of PT00114 could lead to strategic partnerships, licensing agreements, or even acquisition interest from larger pharmaceutical companies seeking to expand their neuropsychiatric portfolios. However, the long-term impact on the company's financials will depend on the clinical trial outcomes, regulatory hurdles and the ability to commercialize the drug effectively in a competitive landscape.
The design of the Phase 1/2a trial for PT00114, which includes both healthy volunteers and patients with specific neuropsychiatric disorders, is tailored to gather early safety and efficacy data. The enrollment of the final two cohorts in the single-dose portion of the Phase 1 trial will provide initial insights into the drug's pharmacokinetics and pharmacodynamics. These insights are important for dose optimization and planning subsequent trial phases.
For stakeholders, the outcome of these early trials will be a key indicator of the drug candidate's potential. It is important to note that the journey from Phase 1 to regulatory approval is long and fraught with challenges. The data collected will not only influence the company's strategic decisions but also inform investors about the potential risks and rewards associated with the drug's development pathway.
- Transitioned from Pre-Clinical to Clinical Stage company in FY 2023
- Phase 1/2a trial, designed to assess both healthy volunteers and patients diagnosed with Treatment-Resistant Depression, PTSD or Generalized Anxiety Disorder, progressing through Phase 1 portion
- Plans to enroll final two out of five cohorts into the single dose portion of the Phase 1 trial within the next month
NEW YORK, NY / ACCESSWIRE / April 1, 2024 / Protagenic Therapeutics, Inc. (NASDAQ:PTIX), a leader in biopharmaceutical innovation, today provided a corporate update and reported financial results for the fourth quarter and full year 2023.
"In 2023, Protagenic Therapeutics achieved a significant milestone as we began enrolling patients for our neuropeptide drug candidate, PT00114," said Dr. Garo Armen, Executive Chairman. "Our primary focus lies in advancing this drug candidate, designed to address the substantial unmet needs across a spectrum of stress-related neuropsychiatric disorders, including Treatment-Resistant Depression, PTSD, Generalized Anxiety Disorder and Addiction withdrawal."
2023 Highlights about PT00114
First Clinical Trial: PT00114, the company's synthetic version of the stress-regulating peptide TCAP, began the single ascending dose (S.A,D,) portion of a Phase 1 clinical trial. Notably, PT00114 has shown excellent tolerability with no adverse safety findings during these ongoing Phase 1 studies. With promising preclinical efficacy in anxiety, depression, PTSD, and addiction models, PT00114 is moving forward in clinical evaluation, representing a key step toward transformative therapies.
Safety Validation: Building on the low dose safety validation announced February 13th, as announced on March 27th, PT00114 has now demonstrated safety at a medium dose of 500 micrograms administered subcutaneously in the third of five planned cohorts of subjects in the single dose portion of the Phase I trial. No adverse reactions were observed among subjects, consistent with the two lower dose cohorts (125 micrograms and 250 micrograms), with no reported injection site reactions or tolerability issues in the week following dosing. Based on preclinical pharmacology, PT00114 is expected to be administered once weekly via subcutaneous injection.
Clinical Protocol Progress: This marks progress in the ongoing Phase 1/2a trial, designed to assess both healthy volunteers and patients diagnosed with Treatment-Resistant Depression, PTSD, or Generalized Anxiety Disorder. The company plans to enroll the final two cohorts into the single dose portion of the Phase 1 trial within the next month.
Comprehensive Approach: In addition to monitoring disease status, the trial incorporates biomarker assessments, including circulating cortisol levels, to measure initial treatment response. Dr. Maurizio Fava, Psychiatrist-in-Chief at Massachusetts General Hospital, serves as the Principal Investigator in Protagenic's Phase 1/2a clinical trial with a basket design.
Strategic Collaboration: Axiom Real-Time Metrics, a CRO/Data Analytics firm, manages the clinical program.
Fourth Quarter and Full Year 2023 Financial Results
Our financial results reflect an increase in research & development spending to pursue our primary objective of developing and commercializing PT00114 during FY 2023, particularly during the fourth quarter. In the fourth quarter of 2023, we spent
For the full year 2023, we spent
For full year net income, we lost
For cash, we ended the year with
Profit and Loss Statements
| For the years ended December 31, | ||||||||
| 2023 | 2022 | |||||||
OPERATING AND ADMINISTRATIVE EXPENSES | ||||||||
Research and development | $ | 3,319,867 | $ | 1,589,239 | ||||
General and administrative | 1,207,107 | 1,968,549 | ||||||
TOTAL OPERATING AND ADMINISTRATIVE EXPENSES | 4,526,974 | 3,557,788 | ||||||
LOSS FROM OPERATIONS | (4,526,974 | ) | (3,557,788 | ) | ||||
OTHER INCOME | ||||||||
Interest income | 264,476 | 185,790 | ||||||
Interest expense | (107,682 | ) | (137,456 | ) | ||||
Realized loss on marketable securities | (630,317 | ) | (46,051 | ) | ||||
TOTAL OTHER INCOME | (473,523 | ) | 2,283 | |||||
LOSS BEFORE TAX | (5,000,497 | ) | (3,555,505 | ) | ||||
INCOME TAX EXPENSE | - | - | ||||||
NET LOSS | $ | (5,000,497 | ) | $ | (3,555,505 | ) | ||
COMPREHENSIVE LOSS | - | - | ||||||
Other Comprehensive Loss - net of tax | ||||||||
Net unrealized gain (loss) on marketable securities | 16,848 | (421,738 | ) | |||||
Reclassification of realized losses on debt securities | 489,120 | - | ||||||
Foreign exchange translation income (loss) | 57,393 | (6,820 | ) | |||||
TOTAL COMPREHENSIVE LOSS | $ | (4,437,136 | ) | $ | (3,984,063 | ) | ||
Net loss per common share - Basic and Diluted | $ | (1.15 | ) | $ | (0.82 | ) | ||
Weighted average common shares - Basic and Diluted | 4,344,580 | 4,317,875 | ||||||
Balance Sheet
| December 31, 2023 | December 31, 2022 | |||||||
ASSETS | ||||||||
CURRENT ASSETS | ||||||||
Cash | $ | 1,287,893 | $ | 215,189 | ||||
Marketable securities | 2,768,119 | 7,763,517 | ||||||
Prepaid expenses | 144,025 | 56,939 | ||||||
TOTAL CURRENT ASSETS | 4,200,037 | 8,035,645 | ||||||
Equipment - net | 123,332 | 1,775 | ||||||
TOTAL ASSETS | $ | 4,323,369 | $ | 8,037,420 | ||||
LIABILITIES AND STOCKHOLDERS' EQUITY | ||||||||
CURRENT LIABILITIES | ||||||||
Accounts payable and accrued expenses | $ | 439,757 | $ | 669,704 | ||||
Accounts payable and accrued expenses - related party | 215,495 | 105,928 | ||||||
PIK convertible notes payable, net of debt discount | - | 150,591 | ||||||
PIK convertible notes payable, net of debt discount - related parties | - | 193,639 | ||||||
TOTAL CURRENT LIABILITIES | 655,252 | 1,119,862 | ||||||
TOTAL LIABILITIES | 655,252 | 1,119,862 | ||||||
STOCKHOLDERS' EQUITY | ||||||||
Preferred stock, | - | - | ||||||
Preferred stock; par value | - | - | ||||||
Series B convertible preferred stock, | - | - | ||||||
Preferred stock value | - | - | ||||||
Common stock, $.0001 par value, 100,000,000 shares authorized, 4,435,132 and 4,321,315 shares issued and outstanding at December 31, 2023, and December 31, 2022 | 444 | 434 | ||||||
Additional paid-in-capital | 34,559,091 | 33,371,406 | ||||||
Accumulated deficit | (30,777,872 | ) | (25,777,375 | ) | ||||
Accumulated other comprehensive loss | (113,546 | ) | (676,907 | ) | ||||
TOTAL STOCKHOLDERS' EQUITY | 3,668,117 | 6,917,558 | ||||||
TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY | $ | 4,323,369 | $ | 8,037,420 | ||||
See accompanying notes to the consolidated financial statements in the company's Form 10-K, filed concurrently.
Conference Call
Date: April 1 , 2024, 4:30 p.m. ET
To access dial-in numbers, please register here.
Participant link (for all regular participants): https://www.webcaster4.com/Webcast/Page/3027/50127.
Or by phone: 888-506-0062
International: 973-528-0011
Participant Access Code: 628544
Webcast
A live webcast and replay of the conference call will be accessible on the company's website at: https://protagenic.com/investor/press-release/
About Protagenic Therapeutics, Inc.:
Protagenic Therapeutics, Inc. (Nasdaq: PTIX) is dedicated to pioneering therapeutics based on neuro-active peptides to alleviate the negative effects of stress and treat stress-related disorders such as anxiety, depression, PTSD, and addiction. For more information, visit www.protagenic.com.
About PT00114:
PT00114, a 41-amino-acid residue synthetic peptide, shows promise as a novel treatment for serious neuro-psychiatric conditions, including depression, anxiety, and PTSD. It is a synthetic form of the naturally occurring brain peptide TCAP, which counters the negative biochemical and behavioral effects of stress-induced brain hormones Corticotropin Releasing Factor and Arginine-Vasopressin. Among its benefits is the reduction of excessive circulating levels of cortisol often associated with various stressors.
Forward-Looking Statements:
This press release contains forward-looking statements concerning Protagenic Therapeutics' product candidates and clinical trial plans. These statements are subject to various risks and uncertainties. Investors are urged to exercise caution and not place undue reliance on these forward-looking statements.
Company Contact:
Alexander K. Arrow, MD, CFA
Chief Financial Officer
Protagenic Therapeutics, Inc. 149 Fifth Ave, Suite 500, New York, NY 10010. Tel: 213-260-4342
Email: alex.arrow@protagenic.com
Investor Relations Contact:
Kirin M. Smith, President, PCG Advisory, Inc. 950 Third Avenue, Suite #2700, New York, NY 10022. Tel: 646-823-8656 Email: ksmith@pcgadvisory.com
SOURCE: Protagenic Therapeutics, Inc.
View the original press release on accesswire.com
FAQ
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