Part I. Financial Information [Financial Statements](index=4&type=section&id=Item%201%20Financial%20Statements) The company reported a **$1.93 million** net loss for the six months ended June 30, 2023, with total assets decreasing and an accumulated deficit of **$27.7 million** raising going concern doubts [Consolidated Balance Sheets](index=4&id=Consolidated%20Balance%20Sheets) Total assets decreased to **$6.92 million** as of June 30, 2023, from **$8.04 million** at year-end 2022, primarily due to reduced marketable securities Consolidated Balance Sheets | Account | June 30, 2023 (Unaudited) ($) | December 31, 2022 ($) | | :--- | :--- | :--- | | **Assets** | | | | Cash | $219,435 | $215,189 | | Marketable securities | $5,823,420 | $7,763,517 | | Total Current Assets | $6,917,526 | $8,035,645 | | **Total Assets** | **$6,919,121** | **$8,037,420** | | **Liabilities & Equity** | | | | Total Current Liabilities | $1,505,390 | $1,119,862 | | **Total Liabilities** | **$1,505,390** | **$1,119,862** | | Total Stockholders' Equity | $5,413,731 | $6,917,558 | | **Total Liabilities and Stockholders' Equity** | **$6,919,121** | **$8,037,420** | [Consolidated Statements of Operations and Comprehensive Loss](index=5&id=Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) Net loss increased to **$1.21 million** for Q2 2023 due to higher R&D expenses, while the six-month net loss slightly decreased to **$1.93 million** Consolidated Statements of Operations and Comprehensive Loss | Metric | Q2 2023 ($) | Q2 2022 ($) | Six Months 2023 ($) | Six Months 2022 ($) | | :--- | :--- | :--- | :--- | :--- | | Research and development | $836,379 | $160,515 | $1,184,410 | $830,353 | | General and administrative | $307,363 | $476,159 | $698,626 | $1,147,597 | | Loss from Operations | $(1,143,742) | $(636,674) | $(1,883,036) | $(1,977,950) | | **Net Loss** | **$(1,209,591)** | **$(666,717)** | **$(1,927,687)** | **$(2,028,826)** | | Net loss per share | $(0.28) | $(0.15) | $(0.45) | $(0.47) | [Consolidated Statements of Cash Flows](index=8&id=Consolidated%20Statements%20of%20Cash%20Flows) Net cash used in operating activities increased to **$1.90 million** for the six months ended June 30, 2023, offset by **$1.91 million** from investing activities, ending with **$219,435** cash Consolidated Statements of Cash Flows | Cash Flow Activity (Six months ended June 30) | 2023 ($) | 2022 ($) | | :--- | :--- | :--- | | Net Cash Used in Operating Activities | $(1,903,576) | $(1,277,645) | | Net Cash Provided by Investing Activities | $1,906,684 | $1,077,679 | | Net Change in Cash | $4,246 | $(202,505) | | **Cash, End of the Period** | **$219,435** | **$338,666** | [Notes to Consolidated Financial Statements](index=9&id=Notes%20to%20Consolidated%20Financial%20Statements) Key notes detail the company's biopharmaceutical focus, a March 2023 reverse stock split, liquidity concerns, outstanding convertible notes, and related-party R&D transactions - The company is a biopharmaceutical firm developing therapeutics for stress-related neuropsychiatric and mood disorders[18](index=18&type=chunk) - A **1-for-4 reverse stock split** was effectuated on March 22, 2023, with all share and per-share data adjusted accordingly[19](index=19&type=chunk) - The company has recurring losses and negative cash flows, raising substantial doubt about its ability to continue as a going concern, though management believes it has sufficient resources to fund operations until the end of **Q3 2024**, alleviating this doubt[20](index=20&type=chunk)[21](index=21&type=chunk) - As of June 30, 2023, the company owes a total of **$430,000** on outstanding convertible notes, maturing on November 6, 2023[53](index=53&type=chunk)[54](index=54&type=chunk) - As of June 30, 2023, the company had **1,357,466 stock options** and **1,055,066 warrants** outstanding[57](index=57&type=chunk)[63](index=63&type=chunk) - The company engaged Agenus Inc. and CTC North, GmbH, related parties, for R&D services, with outstanding balances of **$255,928** and **$80,409** respectively as of June 30, 2023[75](index=75&type=chunk)[76](index=76&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=19&type=section&id=Item%202%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses lead compound PT00114 for stress disorders, with a Phase I/IIa trial planned for Q3 2023, noting increased Q2 losses due to R&D and reiterating sufficient liquidity until Q3 2024 - The company's lead compound, **PT00114**, is a synthetic peptide for treating stress-related disorders including depression, anxiety, and PTSD[82](index=82&type=chunk) - The company anticipates commencing a **Phase I/IIa trial** for PT00114 in the US or Germany in the **third quarter of 2023**[83](index=83&type=chunk) Operational Expense and Loss Trends | Metric (vs. Prior Year Period) | Three Months Ended June 30 ($) | Six Months Ended June 30 ($) | | :--- | :--- | :--- | | R&D Expense | Increased by $675,864 | Increased by $354,057 | | G&A Expense | Decreased by $168,796 | Decreased by $448,971 | | Loss from Operations | Increased to $1,143,742 | Decreased to $1,883,036 | - As of June 30, 2023, the company had cash of **$219,435** and working capital of **$5,412,136**, with sufficient resources to fund operations until the end of **Q3 2024**[87](index=87&type=chunk) [Quantitative and Qualitative Disclosures about Market Risk](index=21&type=section&id=Item%203%20Quantitative%20and%20Qualitative%20Disclosures%20about%20Market%20Risk) This section is not applicable to the company for the current reporting period - The company has stated that this item is not applicable[91](index=91&type=chunk) [Controls and Procedures](index=21&type=section&id=Item%204%20Controls%20and%20Procedures) Management concluded disclosure controls and procedures were ineffective as of June 30, 2023, due to material weaknesses, including insufficient segregation of duties, prompting a remediation plan - Management concluded that disclosure controls and procedures were not effective as of June 30, 2023, due to identified **material weaknesses**[92](index=92&type=chunk) - Identified material weaknesses include insufficient segregation of duties within accounting functions and a limited level of multiple reviews among those preparing financial statements[95](index=95&type=chunk) - To remediate these weaknesses, the company has engaged an independent third party to enhance segregation of duties and implement additional controls[96](index=96&type=chunk) Part II. Other Information [Legal Proceedings](index=22&type=section&id=Item%201%20Legal%20Proceedings) The company reports no pending legal proceedings or investigations expected to have a material adverse effect on its business or financial condition - Currently, no legal proceedings are pending against the company that would be expected to have a material adverse effect[99](index=99&type=chunk) [Risk Factors](index=22&type=page&id=Item%201A%20Risk%20Factors) The company states no material changes to its risk factors from those disclosed in its 2022 Form 10-K - There have been no material changes to the risk factors previously disclosed in the **2022 Form 10-K**[101](index=101&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=22&type=section&id=Item%202%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company reported no unregistered sales of equity securities during the period - None[102](index=102&type=chunk) [Other Information](index=22&type=section&id=Item%205%20Other%20Information) The company reported no other information for the period - None[105](index=105&type=chunk) [Exhibits](index=23&type=section&id=Item%206%20Exhibits) This section lists exhibits filed with the Form 10-Q, including CEO and CFO certifications and Inline XBRL documents - Exhibits filed include **CEO/CFO certifications (31.1, 31.2, 32.1)** and **Inline XBRL data files (101 series)**[107](index=107&type=chunk)

[Part I. Financial Information](index=4&type=section&id=Part%20I.%20Financial%20Information) [Financial Statements](index=4&type=section&id=Item%201%20Financial%20Statements) Unaudited Q1 2023 financial statements detail financial position, operations, equity, and cash flows, noting net loss improvement and going concern considerations [Consolidated Balance Sheets](index=4&type=section&id=Consolidated%20Balance%20Sheets) As of March 31, 2023, total assets decreased to $7.67 million, liabilities increased to $1.25 million, and equity declined to $6.41 million Consolidated Balance Sheets (Unaudited) | Account | March 31, 2023 | December 31, 2022 | | :--- | :--- | :--- | | **Assets** | | | | Cash | $138,491 | $215,189 | | Marketable securities | $7,512,093 | $7,763,517 | | **Total Current Assets** | **$7,664,603** | **$8,035,645** | | **Total Assets** | **$7,666,288** | **$8,037,420** | | **Liabilities & Equity** | | | | Total Current Liabilities | $1,251,975 | $1,119,862 | | **Total Liabilities** | **$1,251,975** | **$1,119,862** | | **Total Stockholders' Equity** | **$6,414,313** | **$6,917,558** | [Consolidated Statements of Operations and Comprehensive Loss](index=5&type=section&id=Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) Q1 2023 net loss improved to $718,096 ($0.17 per share) from $1.36 million ($0.32 per share) in Q1 2022, driven by reduced expenses Consolidated Statements of Operations (Unaudited) | Metric | Q1 2023 | Q1 2022 | | :--- | :--- | :--- | | Research and development | $348,031 | $669,838 | | General and administrative | $391,263 | $671,438 | | **Loss from Operations** | **($739,294)** | **($1,341,276)** | | **Net Loss** | **($718,096)** | **($1,362,109)** | | Net loss per common share | ($0.17) | ($0.32) | [Consolidated Statements of Cash Flows](index=7&type=section&id=Consolidated%20Statements%20of%20Cash%20Flows) Q1 2023 saw net cash used in operations decrease to $371,834, with $294,669 from investing activities, resulting in a cash balance of $138,491 Consolidated Statements of Cash Flows (Unaudited) | Cash Flow Activity | Three Months Ended March 31, 2023 | Three Months Ended March 31, 2022 | | :--- | :--- | :--- | | Net Cash Used in Operating Activities | ($371,834) | ($430,565) | | Net Cash Provided by Investing Activities | $294,669 | $370,763 | | Net Change in Cash | ($76,698) | ($58,996) | | **Cash, End of the Period** | **$138,491** | **$482,175** | [Notes to Consolidated Financial Statements](index=8&type=section&id=Notes%20to%20Consolidated%20Financial%20Statements) Notes detail a 1-for-4 reverse stock split, going concern doubt (alleviated until Q3 2024), outstanding convertible notes, and related party transactions - The company is a **biopharmaceutical firm** focused on developing therapeutics for stress-related neuropsychiatric and mood disorders[16](index=16&type=chunk) - On March 22, 2023, the company executed a **1-for-4 reverse stock split**, with all share and per-share data adjusted to reflect this split[17](index=17&type=chunk) - The company has incurred significant recurring losses and negative cash flows, raising **substantial doubt about its ability to continue as a going concern**, though management believes current resources are **sufficient to fund operations at least until the end of Q3 2024**, alleviating this doubt for the next twelve months[18](index=18&type=chunk)[19](index=19&type=chunk) - As of March 31, 2023, the company has **$430,000 in outstanding convertible notes** ($230,000 to third parties and $200,000 to related parties) that mature on **November 6, 2023**[49](index=49&type=chunk)[50](index=50&type=chunk) - The company has engaged **Agenus Inc.** and its subsidiary **CTC North, GmbH**, which are **related parties**, for research and development services, with outstanding balances of **$105,928** to Agenus and **$65,199** to CTC as of March 31, 2023[70](index=70&type=chunk)[71](index=71&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=16&type=section&id=Item%202%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses lead compound PT00114, reduced Q1 2023 operating loss to $0.74 million, and sufficient cash to fund operations until Q3 2024 - The company's lead compound, **PT00114**, is a synthetic peptide for treating stress-related disorders, with a **Phase I/IIa trial** anticipated to start in **Q3 2023** in the US or Germany[76](index=76&type=chunk)[77](index=77&type=chunk) - The **loss from operations decreased by $601,982** in Q1 2023 compared to Q1 2022, primarily due to a **$321,807 decrease in R&D expenses** and a **$280,175 decrease in G&A expenses**[79](index=79&type=chunk) - As of March 31, 2023, the company had **$138,491 in cash** and **$6.4 million in working capital**, which management believes is **sufficient to fund operations until the end of Q3 2024**, after which additional financing will be required[80](index=80&type=chunk) [Quantitative and Qualitative Disclosures about Market Risk](index=18&type=section&id=Item%203%20Quantitative%20and%20Qualitative%20Disclosures%20about%20Market%20Risk) This section is not applicable to the company - The company has indicated that this item is **not applicable**[84](index=84&type=chunk) [Controls and Procedures](index=18&type=section&id=Item%204%20Controls%20and%20Procedures) Management concluded disclosure controls and procedures were ineffective as of March 31, 2023, due to material weaknesses, and is engaging a third party for remediation - Management concluded that disclosure controls and procedures were **not effective** as of March 31, 2023, due to identified **material weaknesses**[85](index=85&type=chunk) - Identified material weaknesses include: 1) **Insufficient segregation of duties** within accounting functions, and 2) A **limited level of multiple reviews** during financial statement preparation[90](index=90&type=chunk) - To address the material weaknesses, the company has **engaged an independent third party** to enhance segregation of duties and implement additional controls[88](index=88&type=chunk) [Part II. Other Information](index=19&type=section&id=Part%20II.%20Other%20Information) [Legal Proceedings](index=19&type=section&id=Item%201%20Legal%20Proceedings) The company reports no pending legal proceedings, government actions, or investigations expected to have a material adverse effect - As of the report date, the company is **not involved in any material legal proceedings**[91](index=91&type=chunk) [Risk Factors](index=19&type=section&id=Item%201A%20Risk%20Factors) No material changes to risk factors previously disclosed in the 2022 Form 10-K have been reported - There have been **no material changes** to the company's risk factors from those disclosed in the 2022 Form 10-K[93](index=93&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=19&type=section&id=Item%202%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company reported no unregistered sales of equity securities during the period - **None**[94](index=94&type=chunk) [Defaults upon Senior Securities](index=19&type=section&id=Item%203%20Defaults%20upon%20Senior%20Securities) The company reported no defaults upon senior securities - **None**[95](index=95&type=chunk) [Mine Safety Disclosures](index=19&type=section&id=Item%204%20Mine%20Safety%20Disclosures) This section is not applicable to the company - **Not applicable**[96](index=96&type=chunk) [Other Information](index=19&type=section&id=Item%205%20Other%20Information) The company reported no other information for the period - **None**[97](index=97&type=chunk) [Exhibits](index=20&type=section&id=Item%206%20Exhibits) This section lists exhibits filed with Form 10-Q, including Sarbanes-Oxley certifications and Inline XBRL data - The exhibits filed with this Form 10-Q include **CEO and CFO certifications** under **Sarbanes-Oxley Sections 302 and 906**, as well as various **Inline XBRL documents**[100](index=100&type=chunk)

Part I [Business](index=7&type=section&id=Item%201%2E%20Business) Protagenic Therapeutics is a clinical-stage biopharmaceutical company developing treatments for stress-related neuropsychiatric disorders, with its lead candidate PT00114 advancing to a Phase I/IIa study in Q3 2023 - The company is a biopharmaceutical firm developing therapeutics for stress-related neuropsychiatric and mood disorders, with its lead compound being **PT00114**[25](index=25&type=chunk) - Protagenic anticipates re-submitting an Investigational New Drug (IND) application and initiating a **Phase I/IIa study for PT00114 in Q3 2023**, following regulatory feedback[26](index=26&type=chunk)[27](index=27&type=chunk) - The company operates under an exclusive worldwide license agreement with the University of Toronto for its core **TCAP technology**, requiring a **2.5% royalty** on net sales[64](index=64&type=chunk) - As of December 31, 2022, the company holds exclusive rights to a portfolio of intellectual property, including **four issued patents** in the US, Canada, EU, and Australia, with **three additional issued patents** and **ten pending applications**[79](index=79&type=chunk) [Clinical Development and Strategy](index=7&type=section&id=Item%201%2E%20Business%20-%20Clinical%20Development%20and%20Strategy) The company's strategy focuses on advancing its lead candidate, PT00114, through a Phase I/IIa 'basket trial' in Q3 2023 to evaluate safety and preliminary efficacy across multiple neuropsychiatric indications - The company plans a **'basket trial'** to assess safety in healthy volunteers, then safety and preliminary efficacy in patients with depression (MDD), anxiety (GAD), opioid use disorder (OUD), and PTSD[29](index=29&type=chunk)[32](index=32&type=chunk) - The clinical development program is led by **Dr. Maurizio Fava** of Massachusetts General Hospital, who also designed the Phase I/II clinical study[28](index=28&type=chunk) [Market and Competition](index=8&type=section&id=Item%201%2E%20Business%20-%20Market%20and%20Competition) The company targets large neuropsychiatric markets with unmet needs, facing intense competition but believing PT00114's novel mechanism and preclinical profile offer competitive advantages - The target indications represent large patient populations with significant unmet medical needs, including depression, anxiety, PTSD, and substance use disorders[31](index=31&type=chunk)[33](index=33&type=chunk)[36](index=36&type=chunk)[39](index=39&type=chunk)[40](index=40&type=chunk) - The company faces competition from established drug classes such as opioid receptor modulators, atypical antipsychotics (e.g., Rexulti, Vraylar), ketamine/esketamine (Spravato), and emerging GABA/NMDA receptor modulators[69](index=69&type=chunk)[72](index=72&type=chunk)[73](index=73&type=chunk)[74](index=74&type=chunk)[76](index=76&type=chunk)[77](index=77&type=chunk) - PT00114's potential competitive advantages, based on preclinical data, include **rapid onset of action**, **long-lasting effects**, natural crossing of the blood-brain barrier, and an anticipated better safety profile (e.g., no expected liver toxicities, non-addictive)[78](index=78&type=chunk)[80](index=80&type=chunk) [Intellectual Property](index=17&type=section&id=Item%201%2E%20Business%20-%20Intellectual%20Property) Protagenic's crucial intellectual property portfolio, primarily licensed from the University of Toronto, includes four issued patents on its core TCAP technology and additional patents and pending applications as of year-end 2022 Intellectual Property Portfolio Status (as of Dec 31, 2022) | Category | Issued Patents | Pending Applications | | :--- | :--- | :--- | | Original Platform Technology (TCAP) | 4 (US, CA, EU, AU) | - | | Related Technology | 3 | 10 | - The company's exclusive worldwide rights to its core patent applications are secured through a License Agreement with the University of Toronto[79](index=79&type=chunk) [Risk Factors](index=20&type=section&id=Item%201A%2E%20Risk%20Factors) The company faces substantial risks including ongoing operating losses, clinical trial uncertainties, reliance on third parties, potential Nasdaq delisting, and identified material weaknesses in internal financial controls - The company has a history of operating losses, with an accumulated deficit of **$25,777,375** as of December 31, 2022, and expects losses to continue, making its ability to continue as a going concern dependent on raising additional capital[98](index=98&type=chunk)[99](index=99&type=chunk) - The company's lead product candidate, PT00114, is in early development, and there is a high risk of failure in clinical trials, as the drug development and approval process is lengthy, expensive, and uncertain[114](index=114&type=chunk)[118](index=118&type=chunk) - Protagenic relies on third parties for non-clinical studies, clinical trials, and manufacturing, and any failure by these parties to perform could adversely affect its business[131](index=131&type=chunk)[138](index=138&type=chunk) - The company received a Nasdaq deficiency notice for its stock price falling below the **$1.00 minimum bid requirement**, and failure to regain and maintain compliance could lead to delisting[193](index=193&type=chunk)[194](index=194&type=chunk) - Management identified material weaknesses in internal controls over financial reporting, including a lack of segregation of duties and ineffective risk assessment[209](index=209&type=chunk)[210](index=210&type=chunk)[213](index=213&type=chunk) [Unresolved Staff Comments](index=43&type=section&id=Item%201B%2E%20Unresolved%20Staff%20Comments) The company reports no unresolved staff comments from the SEC - Not applicable[219](index=219&type=chunk) [Properties](index=43&type=section&id=Item%202%2E%20Properties) The company does not own real property, operating from leased executive office space in New York - The Company does not own any real property and leases its principal executive office space in New York[220](index=220&type=chunk) [Legal Proceedings](index=43&type=section&id=Item%203%2E%20Legal%20Proceedings) As of December 31, 2022, the company is not involved in any legal proceedings expected to materially affect its business or financial condition - There are no pending legal proceedings that are expected to have a material adverse effect on the company[221](index=221&type=chunk) [Mine Safety Disclosures](index=43&type=section&id=Item%204%2E%20Mine%20Safety%20Disclosures) This item is not applicable to the company's business - Not applicable[222](index=222&type=chunk) Part II [Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities](index=44&type=section&id=Item%205%2E%20Market%20for%20Registrant's%20Common%20Equity%2C%20Related%20Stockholder%20Matters%20and%20Issuer%20Purchases%20of%20Equity%20Securities) The company's common stock and warrants trade on the Nasdaq Capital Market, with limited volume and no anticipated cash dividends as earnings are retained for business development - The company's common stock and warrants are listed on the Nasdaq Capital Market under the symbols **'PTIX'** and **'PTIXW'**, respectively[224](index=224&type=chunk) Quarterly Stock Price (2022, Post-Split Adjusted) | Quarter | High ($) | Low ($) | | :--- | :--- | :--- | | Q1 2022 | 5.80 | 3.20 | | Q2 2022 | 3.68 | 2.60 | | Q3 2022 | 3.20 | 2.28 | | Q4 2022 | 2.60 | 1.40 | - The company has never paid cash dividends and does not intend to in the foreseeable future[227](index=227&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=45&type=section&id=Item%207%2E%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) For 2022, the company's loss from operations decreased to $3.6 million, with $0.2 million cash and $6.9 million working capital, believed sufficient to fund operations until Q3 2024 Results of Operations (in thousands) | Metric | 2022 | 2021 | Change | | :--- | :--- | :--- | :--- | | Research and Development | $1,589 | $1,137 | +$452 | | General and Administrative | $1,969 | $3,004 | -$1,035 | | **Loss from Operations** | **($3,558)** | **($4,140)** | **+$582** | | **Net Loss** | **($3,555)** | **($4,523)** | **+$968** | - The decrease in G&A expenses was primarily due to lower stock compensation expense in 2022 compared to 2021[234](index=234&type=chunk) - As of December 31, 2022, the company had cash of **$215,189** and working capital of **$6,915,783**, which management believes are sufficient to fund operations until the end of Q3 2024[240](index=240&type=chunk)[241](index=241&type=chunk) Cash Flow Summary (in thousands) | Activity | 2022 | 2021 | | :--- | :--- | :--- | | Net Cash Used in Operating | ($1,994) | ($2,799) | | Net Cash Provided by/(Used in) Investing | $1,597 | ($9,910) | | Net Cash Provided by Financing | $0 | $12,578 | [Quantitative and Qualitative Disclosures About Market Risk](index=49&type=section&id=Item%207A%2E%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) This item is not applicable to the company - Not applicable[253](index=253&type=chunk) [Financial Statements and Supplementary Data](index=49&type=section&id=Item%208%2E%20Financial%20Statements%20and%20Supplementary%20Data) Audited consolidated financial statements for 2022 and 2021 show decreased total assets to $8.0 million, stable liabilities, an accumulated deficit of $25.8 million, and a net loss of $3.6 million for 2022 Consolidated Balance Sheet Data (in thousands) | Account | Dec 31, 2022 | Dec 31, 2021 | | :--- | :--- | :--- | | Cash | $215 | $541 | | Marketable Securities | $7,764 | $9,830 | | **Total Assets** | **$8,037** | **$11,060** | | Total Current Liabilities | $1,120 | $800 | | **Total Liabilities** | **$1,120** | **$1,118** | | **Accumulated Deficit** | **($25,777)** | **($22,222)** | | **Total Stockholders' Equity** | **$6,918** | **$9,942** | Consolidated Statement of Operations Data (in thousands) | Account | 2022 | 2021 | | :--- | :--- | :--- | | Research and Development | $1,589 | $1,137 | | General and Administrative | $1,969 | $3,004 | | **Loss from Operations** | **($3,558)** | **($4,140)** | | **Net Loss** | **($3,555)** | **($4,523)** | | **Net Loss Per Share** | **($0.82)** | **($1.24)** | - The company effectuated a **1-for-4 reverse stock split** on March 22, 2023, and all share and per-share data in the financial statements have been adjusted to reflect this split[429](index=429&type=chunk) [Changes in and Disagreements with Accountants on Accounting and Financial Disclosure](index=49&type=section&id=Item%209%2E%20Changes%20in%20and%20Disagreements%20with%20Accountants%20on%20Accounting%20and%20Financial%20Disclosure) The company reports no changes in or disagreements with its accountants on accounting and financial disclosure - None[255](index=255&type=chunk) [Controls and Procedures](index=50&type=section&id=Item%209A%2E%20Controls%20and%20Procedures) Management concluded that internal controls over financial reporting were ineffective as of December 31, 2022, due to material weaknesses, with a remediation plan initiated - Management concluded that internal control over financial reporting was **not effective** as of December 31, 2022[257](index=257&type=chunk)[260](index=260&type=chunk) - Material weaknesses were identified, including: 1) lack of adequate segregation of duties within accounting functions, and 2) a limited level of multiple reviews in the financial reporting process[262](index=262&type=chunk)[268](index=268&type=chunk) - To remediate these weaknesses, the company has engaged an independent third party to help enhance segregation of duties and implement additional controls[265](index=265&type=chunk) [Other Information](index=52&type=section&id=Item%209B%2E%20Other%20Information) The company executed a 1-for-4 reverse stock split on March 22, 2023, to regain Nasdaq compliance after receiving a deficiency notice for its minimum bid price - On March 22, 2023, the company implemented a **1-for-4 reverse stock split** to regain compliance with Nasdaq's minimum **$1.00 bid price requirement**[270](index=270&type=chunk) Part III [Directors, Executive Officers and Corporate Governance](index=53&type=section&id=Item%2010%2E%20Directors%2C%20Executive%20Officers%20and%20Corporate%20Governance) This section details the company's leadership, board composition, five standing committees, and adopted Code of Business Conduct and Ethics - The executive team includes **Garo H. Armen, PhD**, as Executive Chairman and **Alexander K. Arrow, M.D., CFA**, as Chief Financial Officer[275](index=275&type=chunk) - The Board of Directors has five standing committees: Audit, Compensation, Nominating and Corporate Governance, Science, and Clinical and Regulatory[296](index=296&type=chunk) - The Audit Committee is composed of independent directors Brian Corvese (Chairperson), Timothy Wright, and Khalil Barrage, with Mr. Corvese designated as the **'audit committee financial expert'**[297](index=297&type=chunk) [Executive Compensation](index=59&type=section&id=Item%2011%2E%20Executive%20Compensation) Executive compensation for 2022 primarily included a $150,000 CFO salary, with other officers and directors compensated mainly through stock option grants Summary Compensation (2022) | Name and Principal Position | Salary ($) | Option Awards ($) | Total ($) | | :--- | :--- | :--- | :--- | | Garo H. Armen, Chairman | 0 | 0 | 0 | | Alexander K. Arrow, CFO | 150,000 | 0 | 150,000 | - Compensation for key personnel, including the COO, CMO, and scientific advisors, is provided through consulting agreements and primarily consists of stock option grants[312](index=312&type=chunk)[314](index=314&type=chunk)[315](index=315&type=chunk) - Non-employee directors are compensated with annual grants of stock options, with additional options for chairing a committee[319](index=319&type=chunk) [Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters](index=61&type=section&id=Item%2012%2E%20Security%20Ownership%20of%20Certain%20Beneficial%20Owners%20and%20Management%20and%20Related%20Stockholder%20Matters) As of March 26, 2023, Executive Chairman Garo H. Armen was the largest beneficial owner with 26% of common stock, while all directors and executive officers collectively owned 36% - Executive Chairman **Garo H. Armen** is the largest beneficial owner with **26%** of the common stock[371](index=371&type=chunk) - All directors and executive officers as a group beneficially own approximately **36%** of the company's outstanding common stock[371](index=371&type=chunk) Equity Compensation Plan Information (as of Dec 31, 2022) | Plan category | Securities to be issued upon exercise | Weighted-average exercise price ($) | Securities remaining available for future issuance | | :--- | :--- | :--- | :--- | | Approved by security holders | 2,894,624 | $10.54 | 48,719 | [Certain Relationships and Related Transactions, and Director Independence](index=71&type=section&id=Item%2013%2E%20Certain%20Relationships%20and%20Related%20Transactions%2C%20and%20Director%20Independence) The company discloses related-party transactions, including no-cost office space from Agenus, convertible note investments, and stock option grants, with a formal review policy and independent director determinations - The company utilizes office space from Agenus, Inc., where Executive Chairman Dr. Garo Armen is also Chairman and CEO, at no cost[380](index=380&type=chunk) - Past related-party transactions include investments in a convertible note offering by Dr. Armen and director Khalil Barrage, and stock option grants to Dr. Armen's son for consulting work[382](index=382&type=chunk)[383](index=383&type=chunk) - The Board has determined that Messrs. Barrage, Corvese, and Wright are independent directors, while Dr. Buell and Dr. Stein are not considered independent due to their roles and relationships with the company and its chairman[387](index=387&type=chunk)[390](index=390&type=chunk)[391](index=391&type=chunk) [Principal Accountant Fees and Services](index=73&type=section&id=Item%2014%2E%20Principal%20Accountant%20Fees%20and%20Services) This section details fees paid to Malone Bailey LLP for audit and other services in fiscal years 2022 and 2021, all pre-approved by the Audit Committee Accountant Fees (Malone Bailey LLP) | Fee Type | Fiscal Year 2022 ($) | Fiscal Year 2021 ($) | | :--- | :--- | :--- | | Audit fees | $85,000 | $68,000 | | Audit-related fees | $0 | $62,750 | | Tax Fees | $0 | $0 | | All other fees | $0 | $0 | | **Total** | **$85,000** | **$130,750** | Part IV [Exhibits, Financial Statement Schedules](index=74&type=section&id=Item%2015%2E%20Exhibits%2C%20Financial%20Statement%20Schedules) This section lists all documents filed as part of the Form 10-K report, including consolidated financial statements and a comprehensive index of exhibits - This section provides a list of all financial statements, schedules, and exhibits filed with the Form 10-K, including the company's certificate of incorporation, bylaws, material contracts like the technology license agreement, and executive certifications[399](index=399&type=chunk)[402](index=402&type=chunk)[403](index=403&type=chunk)[404](index=404&type=chunk)

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q Commission File Number: 001-12555 PROTAGENIC THERAPEUTICS, INC. (Exact name of registrant as specified in its charter) Delaware 06-1390025 (State or other jurisdiction of (I.R.S. Employer incorporation or organization) Identification No.) 149 Fifth Avenue, Suite 500, New York, New York 10010 (Address of Principal Executive Office) (Zip Code) (Mark One) ☒ Quarterly Report Pursuant to Section 13 or 15(d) of the Securities Exchan ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ Quarterly Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 For the quarterly period ended June 30, 2022 or ☐ Transition Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 For the transition period from _________to___________ Commission File Number: 000-51353 PROTAGENIC THERAPEUTICS, INC. (Exact name of registrant as specified in its charter) Delaware 06-13900 ...

☒ Quarterly Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 For the quarterly period ended March 31, 2022 or ☐ Transition Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 For the transition period from _________to___________ Commission File Number: 000-51353 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) PROTAGENIC THERAPEUTICS, INC. (Exact name of registrant as specified in its charter) Delaware 06-1390 ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-K ☒ ANNUAL REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For fiscal year ended: December 31, 2021 OR ☐ TRANSITION REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _______________ to _______________ Commission file number: 000-51353 Protagenic Therapeutics, Inc. (Exact name of registrant as specified in its charter) | Delaware | 06-1390025 | | --- | - ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ Quarterly Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 For the quarterly period ended September 30, 2021 or ☐ Transition Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 For the transition period from _________to___________ Commission File Number: 000-51353 PROTAGENIC THERAPEUTICS, INC. (Exact name of registrant as specified in its charter) Delaware 06- ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ Quarterly Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 For the quarterly period ended June 30, 2021 or ☐ Transition Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 For the transition period from _________to___________ Commission File Number: 000-51353 PROTAGENIC THERAPEUTICS, INC. (Exact name of registrant as specified in its charter) Delaware 06-13900 ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) [X] Quarterly Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 For the quarterly period ended March 31, 2021 or [ ] Transition Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 For the transition period from _________to___________ Commission File Number: 000-51353 PROTAGENIC THERAPEUTICS, INC. (Exact name of registrant as specified in its charter) Delaware 06- ...