美国
证券交易委员会
华盛顿，特区。20549
表格
(马克 一)
| 季度 根据1934年证券交易法第13或15(d)条的报告 |
截至季度结束
or
| 根据1934年证券交易法第13或15(d)节的过渡报告 |
在 <blank> <blank> 过渡期间
委员会
文件编号：
（公司章程中指定的准确公司名称）
| （注册地或组织所在管辖区） | （美国国税局雇主号码） | |
| 文件号码） | (主要 执行人员之地址) |
(323) 888-9999
注册人 电话号码，包括区号
根据法案第12(b)节注册的证券:
| 每一类别的名称 | 逐笔明细符号（s） | 在每个交易所注册的名称 | ||
请勾选标记以指示注册者是否（1）在过去12个月内（或注册者需要提交这些报告的更短时间内）已提交证券交易所法案第13或15（d）节要求提交的所有报告，及 （2）是否已被提交要求过去90天的提交要求所制约。
请在勾选框内勾选，以指示注册人在过去的12个月内(或注册人需要提交这些文件的时间更短)是否已经电子提交了每一份互动数据文件，该提交是根据证券法规定第405条规则和本章第232.405条规则规定。
请用勾选来指示注册者是大型加速申报人、加速申报人、非加速申报人、较小报告公司或新兴成长公司。有关“大型加速申报人”、“加速申报人”、“较小报告公司”和“新兴成长公司”的定义，请参见《交易所法》第120亿.2条。
| 大型加速文件提交人 | ☐ | 加速文件提交人 | ☐ |
| ☒ | 小型报告公司 | ||
| 新兴成长公司 |
如果是新兴成长型企业，请打勾，以表明注册人已选择不使用遵守《证券交易法》第13(a)条所规定的任何新的或修订后的财务会计准则的延长过渡期。 ☐
请通过勾选来指示注册人是否为空壳公司（根据《交易所法》第126-2条的定义）。☐ 是
截至2024年11月11日，有 普通股股票，$ 每股面值，尚有流通。
普罗泰因治疗公司。
表格 10-Q报告
截至2024年9月30日的财政季度
目录
| 页面 | |||
| 第一部分。 | 财务信息 | ||
| 项目 1 | 基本报表: | ||
| 2024年9月30日和2023年12月31日的合并资产负债表（未经审计） | 3 | ||
| 截至2024年9月30日和2023年的三个和九个月的合并损益表和综合损益表（未经审计） | 4 | ||
| 2024年和2023年截至9月30日的股东权益变动表（未经审计） | 5 | ||
| 2024年9月30日止的未经审计的综合现金流量表和2023年 | 6 | ||
| 合并财务报表注释（未经审计） | 7 | ||
| 项目 2 | 分销计划 | 16 | |
| 项目 3 | 市场风险的定量和定性披露 | 18 | |
| 项目 4 | 控制和程序 | 19 | |
| 第二部分。 | 其他信息 | ||
| 项目 1 | 法律诉讼 | 20 | |
| 项目 1A | 风险因素 | 20 | |
| 项目 2 | 未注册的股票股权销售和筹款用途 | 20 | |
| 项目 3 | 对高级证券的违约。 | 20 | |
| 项目 4 | 矿山安全披露 | 20 | |
| 项目 5 | 其他信息 | 20 | |
| 项目 6 | 展示资料 | 20 | |
| 签名 | 21 | ||
| 2 |
第I部分 - 财务信息
项目 1. 基本报表
原生物疗法公司及其子公司
汇总资产负债表
(未经审计)
| 2024年9月30日 | 2023年12月31日 | |||||||
| 资产 | ||||||||
| 流动资产 | ||||||||
| 现金 | $ | $ | ||||||
| 可交易证券 | ||||||||
| 预付费用 | ||||||||
| 总流动资产 | ||||||||
| 设备 - 净 | ||||||||
| 资产总计 | $ | $ | ||||||
| 负债和股东权益 | ||||||||
| 流动负债 | ||||||||
| 应付账款和应计费用 | $ | $ | ||||||
| 应付账款和应计费用 - 关联方 | ||||||||
| 流动负债合计 | ||||||||
| 负债合计 | ||||||||
| 股东权益 | ||||||||
| 优先股，$0.0001 面值； 授权股份数; 以下类别中已发行和流通股份： | ||||||||
| 优先股；面值$; 授权股份数; 已发行并流通 | ||||||||
| B类可转换优先股，$ 每股面值； 授权股份数; 和 2024年9月30日和2023年12月31日的已发行和流通股份 | ||||||||
| 普通股，每股面值为 $0.0001； 面值， 授权股数， 和 2024年9月30日和2023年12月31日发行和流通的股份 | ||||||||
| 股本溢价 | ||||||||
| 累积赤字 | ( | ) | ( | ) | ||||
| 累计其他综合损失 | ( | ) | ( | ) | ||||
| 总股东权益 | ||||||||
| 负债和股东权益总计 | $ | $ | ||||||
请参见相关说明以了解未经审计的合并基本报表
| 3 |
PROTAGENIC THERAPEUTICS, INC.及其附属公司
合并 运营和全面亏损报表
(未经审计)
截至三个月 九月三十日 | 截至九个月 九月三十日 | |||||||||||||||
| 2024 | 2023 | 2024 | 2023 | |||||||||||||
| 运营和管理费用 | ||||||||||||||||
| 研究和开发 | $ | $ | $ | $ | ||||||||||||
| 研发 - 关联方 | ||||||||||||||||
| 一般管理费用 | ||||||||||||||||
| 总运营和管理费用 | ||||||||||||||||
| 来自运营的亏损 | ( | ) | ( | ) | ( | ) | ( | ) | ||||||||
| 其他（费用）收入 | ||||||||||||||||
| 利息收入 | ||||||||||||||||
| 利息支出 | ( | ) | ( | ) | ||||||||||||
| 已实现的可交易证券收益（亏损） | ( | ) | ( | ) | ||||||||||||
| 应计负债结算的收益 | ||||||||||||||||
| 其他收入（费用）合计 | ( | ) | ||||||||||||||
| 税前亏损 | ( | ) | ( | ) | ( | ) | ( | ) | ||||||||
| 所得税费用 | ||||||||||||||||
| 净损失 | $ | ( | ) | $ | ( | ) | $ | ( | ) | $ | ( | ) | ||||
| 综合损失 | ||||||||||||||||
| 其他综合损失 - 税后 | ||||||||||||||||
| 可交易证券的未实现收益（损失） | ( | ) | ||||||||||||||
| 债务证券已实现损失的重分类 | ( | ) | ||||||||||||||
| 汇率期货翻译收入（损失） | ( | ) | ||||||||||||||
| 总综合亏损 | $ | ( | ) | $ | ( | ) | $ | ( | ) | $ | ( | ) | ||||
| 每普通股净亏损 - 基本和稀释 | $ | ) | $ | ) | $ | ) | $ | ) | ||||||||
| 加权平均普通股 - 基本和稀释 | ||||||||||||||||
请参见相关说明以了解未经审计的合并基本报表
| 4 |
PROTAGENIC THERAPEUTICS, INC.及其附属公司
合并 股东权益变动表
截至2024年和2023年9月30日的三个月和九个月
(未经审计)
B轮 Convertible 优先股 | 普通股 | 额外 已缴纳- | 累计 | 累计 其他 综合的 | 股东的 | |||||||||||||||||||||||||||
| 股份 | 金额 | 股份 | 金额 | 资本 | (赤字) | Loss | 股权 | |||||||||||||||||||||||||
| 余额 – 2022年12月31日 | $ | $ | $ | $ | ( | ) | $ | ( | ) | $ | | |||||||||||||||||||||
| 外币翻译收益 | - | - | ||||||||||||||||||||||||||||||
| 可市场证券的未实现收益 | - | - | ||||||||||||||||||||||||||||||
| 股票补偿 - 期权 | - | - | ||||||||||||||||||||||||||||||
| 反向拆股后的四舍五入 | - | |||||||||||||||||||||||||||||||
| 净损失 | - | - | ( | ) | ( | ) | ||||||||||||||||||||||||||
| 资产负债表 – 2023年3月31日 | $ | $ | $ | $ | ( | ) | $ | ( | ) | $ | ||||||||||||||||||||||
| 外币翻译收益 | - | - | ||||||||||||||||||||||||||||||
| 可市场证券的未实现收益 | - | - | ||||||||||||||||||||||||||||||
| 股票补偿 - 期权 | - | - | ||||||||||||||||||||||||||||||
| 净损失 | - | - | ( | ) | ( | ) | ||||||||||||||||||||||||||
| 资产负债表 – 2023年6月30日 | $ | $ | $ | $ | ( | ) | $ | ( | ) | $ | ||||||||||||||||||||||
| 外币翻译收益 | - | - | ||||||||||||||||||||||||||||||
| 未实现市场证券损失 | - | - | ( | ) | ( | ) | ||||||||||||||||||||||||||
| 股票补偿 - 期权 | - | - | ||||||||||||||||||||||||||||||
| 净损失 | - | - | ( | ) | ( | ) | ||||||||||||||||||||||||||
| 余额 - 2023年9月30日 | $ | $ | $ | $ | ( | ) | $ | ( | ) | $ | ||||||||||||||||||||||
| 余额 - 2023年12月31日 | ( | ) | ( | ) | ||||||||||||||||||||||||||||
| 外币翻译收益 | - | - | ||||||||||||||||||||||||||||||
| 可市场证券的未实现收益 | - | - | ||||||||||||||||||||||||||||||
| 股票补偿 - 期权 | - | - | ||||||||||||||||||||||||||||||
| 净损失 | - | - | ( | ) | ( | ) | ||||||||||||||||||||||||||
| 余额 - 2024年3月31日 | ( | ) | ( | ) | ||||||||||||||||||||||||||||
| 外币翻译收益 | - | - | ||||||||||||||||||||||||||||||
| 已实现债务证券损失的重新分类 | - | - | ( | ) | ( | ) | ||||||||||||||||||||||||||
| 股票补偿 - 期权 | - | - | ||||||||||||||||||||||||||||||
| 以现金发行的股票 | - | |||||||||||||||||||||||||||||||
| 净损失 | - | - | ( | ) | ( | ) | ||||||||||||||||||||||||||
| 余额 - 2024年6月30日 | $ | $ | $ | $ | ( | ) | $ | ( | ) | $ | ||||||||||||||||||||||
| 外币翻译损失 | - | - | ( | ) | ( | ) | ||||||||||||||||||||||||||
| 股票补偿 - 股票期权 | - | - | ||||||||||||||||||||||||||||||
| 为现金发行的股票 | ||||||||||||||||||||||||||||||||
| 净损失 | ( | ) | ( | ) | ||||||||||||||||||||||||||||
| 余额 - 2024年9月30日 | $ | $ | $ | $ | ( | ) | $ | ( | ) | $ | ||||||||||||||||||||||
请参见相关说明以了解未经审计的合并基本报表
| 5 |
PROTAGENIC THERAPEUTICS, INC.及其附属公司
合并现金流量表
(未经审计)
| 截至9月30日的九个月情况 | ||||||||
| 2024 | 2023 | |||||||
| 经营活动产生的现金流量 | ||||||||
| 净亏损 | $ | ( | ) | $ | ( | ) | ||
| 调整净亏损与经营活动使用的净现金 | ||||||||
| 折旧费用 | ||||||||
| 基于股票的补偿 | ||||||||
| 已实现（收益）出售可交易证券的损失 | ( | ) | ||||||
| 债务折扣的摊销 | ||||||||
| 结算应计负债的收益 | ( | ) | ||||||
| 经营资产和负债的变化 | ||||||||
| 预付费用 | ( | ) | ( | ) | ||||
| 应付账款和预提费用 | ( | ) | ||||||
| 应付账款和应计费用 - 相关方 | ( | ) | ||||||
| 经营活动中使用的净现金 | ( | ) | ( | ) | ||||
| 投资活动现金流量 | ||||||||
| 出售有价证券的收益 | ||||||||
| 购买可交易的证券 | ( | ) | ( | ) | ||||
| 固定资产的购买 | ( | ) | ||||||
| 通过投资活动提供的净现金 | ||||||||
| 融资活动的现金流 | ||||||||
| 发行股份所得，减去发行成本 | ||||||||
| 融资活动提供的现金净额 | ||||||||
| 汇率变化对现金的影响 | ||||||||
| 现金净变动 | ( | ) | ( | |||||
| 现金，期初 | ||||||||
| 现金，期末 | $ | $ | ||||||
| 现金流信息的补充披露 | ||||||||
| 支付的利息费用 | $ | $ | ||||||
| 支付的所得税现金 | $ | $ | ||||||
| 非现金融资和投资交易 | ||||||||
| 可市场证券的未实现收益 | $ | $ | ||||||
请参见相关说明以了解未经审计的合并基本报表
| 6 |
原生药物 生物科技公司及其子公司
附注 合并基本报表
2024年9月30日
(未经审计)
注意 1 - 组织和业务性质
公司 背景
Protagenic Therapeutics, Inc.（“我们”，“我们的”，“Protagenic”或“公司”），前身为Atrinsic, Inc.，是一个注册于特拉华州的公司，拥有一家名为Protagenic Therapeutics Canada (2006) Inc.（“PTI Canada”）的子公司，该公司于2006年在加拿大安大略省的法律下成立。
我们是一家生物制药公司，专注于发现和开发治疗与压力相关的神经精神疾病和情绪障碍的疗法。
NOTE 2 – LIQUIDITY AND GOING CONCERN
As shown in the accompanying consolidated financial statements, the Company has incurred significant recurring losses resulting in an accumulated deficit. The Company anticipates further losses in the development of its business. The Company also had negative cash flows used in operations. These factors raise substantial doubt about the Company’s ability to continue as a going concern.
Based on its cash resources and positive working capital as of September 30, 2024, the Company does not have sufficient resources to fund its operations past twelve months from the date these consolidated financial statements are available to be issued. The positive working capital as of September 30, 2024 was due to funds raised by the Company from its equity offering during the year ended December 31, 2021. Absent generation of sufficient revenue from the execution of the Company’s business plan, the Company will need to obtain debt or equity financing by the third quarter of 2025. Because the Company has insufficient resources on hand to fund operations through the next twelve months from the date these consolidated financial statements are available to be issued, the Company believes that there is substantial doubt in its ability to continue as a going concern. These financial statements do not include any adjustments to the recoverability and classification of recorded asset amounts and classification of liabilities that might be necessary should the Company be unable to continue as a going concern.
| 7 |
NOTE 3 - SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
Basis of presentation
The accompanying unaudited consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”) for interim financial information and the rules and regulations of the Securities and Exchange Commission (“SEC”) for interim financial information. In the opinion of the Company’s management, the accompanying consolidated financial statements reflect all adjustments, consisting of normal, recurring adjustments, considered necessary for a fair presentation of the results for the interim periods ended September 30, 2024 and 2023. Although management believes that the disclosures in these unaudited condensed consolidated financial statements are adequate to make the information presented not misleading, certain information and footnote disclosures normally included in financial statements that have been prepared in accordance with U.S. GAAP have been condensed or omitted pursuant to the rules and regulations of the Securities and Exchange Commission (the “SEC”).
The accompanying unaudited consolidated financial statements should be read in conjunction with the Company’s financial statements for the year ended December 31, 2023, which contain the audited financial statements and notes thereto, for the years ended December 31, 2023 and 2022 included within the Company’s Form 10-K filed with the SEC on April 1, 2024 and 10-K/A filed with the SEC on May 14, 2024. The interim results for the period ended September 30, 2024 are not necessarily indicative of the results to be expected for the year ending December 31, 2024 or for any future interim periods.
Reclassification
Certain reclassifications have been made to prior period amounts to conform to the current period financial statement presentation. These reclassifications relate to presenting “Research and development with related parties” as a separate line item in the Company’s Condensed Consolidated Statements of Operations and Comprehensive Loss.
Principles of consolidation
The consolidated financial statements include the accounts of Protagenic Therapeutics, Inc., and its wholly owned Canadian subsidiary, PTI Canada. All significant intercompany balances and transactions have been eliminated.
Use of estimates
The preparation of the consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the consolidated financial statements and the reported amounts of revenue and expense during the reporting period. Actual results could differ from those estimates. Significant estimates underlying the consolidated financial statements include valuation of stock options and warrants and assessment of deferred tax asset valuation allowance.
Concentrations of Credit Risk
The Company maintains its cash accounts at financial institutions which are insured by the Federal Deposit Insurance Corporation. At times, the Company may have deposits in excess of federally insured limits. As of September 30, 2024, the Company has bank balances that exceed the federally insured limits. The Company has not experienced losses on these accounts and management believes, based upon the quality of the financial institutions, that the credit risk with regard to these deposits is not significant.
Cash and Cash Equivalents
The
Company considers all highly liquid investments with an original maturity of three months or less when purchased to be cash equivalents.
As of September 30, 2024 and December 31, 2023 the Company did not have any cash equivalents. As of September 30, 2024 and December 31,
2023, the Company had cash of $
Marketable Securities
The Company accounts for marketable debt securities, the only type of securities it owns, in accordance with the FASB Accounting Standards Codification 320, Investments – Debt and Equity Securities (“ASC 320”).
| 8 |
Pursuant to ASC 320-10-35-1, investments in debt securities that are classified as available for sale shall be measured subsequently at fair value in the consolidated balance sheets at each balance sheet date. Unrealized holding gains and losses for available-for-sale securities (including those classified as current assets) shall be excluded from earnings and reported in other comprehensive income until realized.
During
the three months ended September 30, 2024 the Company purchased $
Equipment
Equipment
is stated at cost less accumulated depreciation. Cost includes expenditures for computer equipment and lab equipment. Maintenance and
repairs are charged to expense as incurred. When assets are sold, retired, or otherwise disposed of, the cost and accumulated depreciation
are removed from the accounts and any resulting gain or loss is reflected in operations. The cost of equipment is depreciated using the
straight-line method over the estimated useful lives of the related assets which is three years. Depreciation expense was $
Fair Value Measurements
ASC 820, “Fair Value Measurements and Disclosure,” defines fair value as the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date, not adjusted for transaction costs. ASC 820 also establishes a fair value hierarchy that prioritizes the inputs to valuation techniques used to measure fair value into three broad levels giving the highest priority to quoted prices in active markets for identical assets or liabilities (Level 1) and the lowest priority to unobservable inputs (Level 3).
The three levels are described below:
Level 1 Inputs – Unadjusted quoted prices in active markets for identical assets or liabilities that is accessible by the Company;
Level 2 Inputs – Quoted prices in markets that are not active or financial instruments for which all significant inputs are observable, either directly or indirectly;
Level 3 Inputs – Unobservable inputs for the asset or liability including significant assumptions of the Company and other market participants.
The carrying amount of the Company’s financial assets and liabilities, such as cash, accounts payable and accrued expenses approximate their fair value because of the short term maturity of those instruments.
Transactions involving related parties cannot be presumed to be carried out on an arm’s-length basis, as the requisite conditions of competitive, free-market dealings may not exist. Representations about transactions with related parties, if made, shall not imply that the related party transactions were consummated on terms equivalent to those that prevail in arm’s-length transactions unless such representations can be substantiated.
The assets or liability’s fair value measurement within the fair value hierarchy is based upon the lowest level of any input that is significant to the fair value measurement. The following table provides a summary of financial instruments that are measured at fair value on a recurring basis as of September 30, 2024.
| Carrying | Fair Value Measurement Using | |||||||||||||||||||
| Value | Level 1 | Level 2 | Level 3 | Total | ||||||||||||||||
| Marketable securities | $ | $ | $ | $ | $ | |||||||||||||||
| 9 |
The following table provides a summary of financial instruments that are measured at fair value on a recurring basis as of December 31, 2023.
| Carrying | Fair Value Measurement Using | |||||||||||||||||||
| Value | Level 1 | Level 2 | Level 3 | Total | ||||||||||||||||
| Marketable securities | $ | $ | $ | $ | $ | |||||||||||||||
Stock-Based Compensation
The Company accounts for stock-based compensation costs under the provisions of ASC 718, “Compensation—Stock Compensation”, which requires the measurement and recognition of compensation expense related to the fair value of stock-based compensation awards that are ultimately expected to vest. Stock based compensation expense recognized includes the compensation cost for all stock-based payments granted to employees, officers, non-employees, and directors based on the grant date fair value estimated in accordance with the provisions of ASC 718. ASC 718 is also applied to awards modified, repurchased, or cancelled during the periods reported.
If any award granted under the Company’s 2016 Equity Compensation Plan (the “2016 Plan”) payable in shares of common stock is forfeited, cancelled, or returned for failure to satisfy vesting requirements, otherwise terminates without payment being made, or if shares of common stock are withheld to cover withholding taxes on options or other awards, the number of shares of common stock as to which such option or award was forfeited, or which were withheld, will be available for future grants under the 2016 Plan. The Company recognizes the impact of forfeitures when they occur.
Basic (loss) per common share is computed by dividing the net (loss) by the weighted average number of shares of common stock outstanding for each period. Diluted (loss) per share is computed by dividing the net (loss) by the weighted average number of shares of common stock outstanding plus the dilutive effect of shares issuable through the common stock equivalents. The effect of dilution on net loss becomes anti-dilutive and therefore is not reflected on the consolidated statements of operations and comprehensive loss.
| Potentially Outstanding Dilutive Common Shares | ||||||||
| For the Nine Months Ended September 30, 2024 | For the Nine Months Ended September 30, 2023 | |||||||
| Conversion Feature Shares | ||||||||
| Stock Options | ||||||||
| Warrants | ||||||||
| Convertible Notes | ||||||||
| Total potentially outstanding dilutive common shares | ||||||||
Research and Development
Research and development expenses are charged to operations as incurred.
| 10 |
Foreign Currency Translation
The Company follows ASC 830, Foreign Currency Matters (“ASC 830”) for foreign currency translation to translate the financial statements of the foreign subsidiary from the functional currency, generally the local currency, into U.S. Dollars. ASC 830-10-45 sets out the guidance relating to how a reporting entity determines the functional currency of a foreign entity (including of a foreign entity in a highly inflationary economy), re-measures the books of record (if necessary), and characterizes transaction gains and losses. Pursuant to ASC 830-10-45, the assets, liabilities, and operations of a foreign entity shall be measured using the functional currency of that entity. An entity’s functional currency is the currency of the primary economic environment in which the entity operates; normally, that is the currency of the environment, or local currency, in which an entity primarily generates and expends cash.
The functional currency of each foreign subsidiary is determined based on management’s judgment and involves consideration of all relevant economic facts and circumstances affecting the subsidiary. Generally, the currency in which the subsidiary transacts a majority of its transactions, including billings, financing, payroll and other expenditures, would be considered the functional currency, but any dependency upon the parent and the nature of the subsidiary’s operations must also be considered. If a subsidiary’s functional currency is deemed to be the local currency, then any gain or loss associated with the translation of that subsidiary’s financial statements is included in accumulated other comprehensive income. However, if the functional currency is deemed to be the U.S. Dollar, then any gain or loss associated with the re-measurement of these financial statements from the local currency to the functional currency would be included in the consolidated statements of operations and comprehensive income (loss). If the Company disposes of foreign subsidiaries, then any cumulative translation gains or losses would be recorded into the consolidated statements of operations and comprehensive income (loss). If the Company determines that there has been a change in the functional currency of a subsidiary to the U.S. Dollar, any translation gains or losses arising after the date of change would be included within the consolidated statements of operations and comprehensive loss.
Based on an assessment of the factors discussed above, the management of the Company determined its subsidiary’s local currency (i.e. the Canadian dollar) to be the functional currency for its foreign subsidiary.
Recent Accounting Pronouncements
In August 2020, the FASB issued ASU 2020-06, which simplifies the guidance on the issuer’s accounting for convertible debt instruments by removing the separation models for convertible debt with a cash conversion feature and convertible instruments with a beneficial conversion feature. As a result, entities will not separately present in equity an embedded conversion feature in such debt and will account for a convertible debt instrument wholly as debt, unless certain other conditions are met. The elimination of these models will reduce reported interest expense and increase reported net income for entities that have issued a convertible instrument that is within the scope of ASU 2020-06. Also, ASU 2020-06 requires the application of the if-converted method for calculating diluted earnings per share and treasury stock method will be no longer available. ASU 2020-06 is applicable for fiscal years beginning after December 15, 2023, with early adoption permitted no earlier than fiscal years beginning after December 15, 2020. The adoption of this ASU did not have a material effect on the Company’s financial statements.
In November 2023, the FASB issued ASU 2023-07, “Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures,” which is intended to improve reportable segment disclosure requirements, primarily through enhanced disclosures about significant segment expenses. The purpose of the amendment is to enable investors to better understand an entity’s overall performance and assess potential future cash flows. The guidance is effective for fiscal years beginning after December 15, 2023, and interim periods within fiscal years beginning after December 15, 2024, with early adoption permitted. The guidance is to be applied retrospectively to all prior periods presented in the financial statements. The Company is continuing to evaluate the impact of adopting this new guidance but does not expect it to have a material impact on the Company’s financial statements.
NOTE 4 - ACCOUNTS PAYABLE AND ACCRUED EXPENSES
Accounts payable and accrued expenses consist of the following at:
| September 30, 2024 | December 31, 2023 | |||||||
| Accounting | $ | $ | ||||||
| Research and development | ||||||||
| Legal | ||||||||
| Other | ||||||||
| Total | $ | $ | ||||||
| 11 |
NOTE 5 - STOCKHOLDERS’ EQUITY
Common Stock
During the nine months ended September 30, 2024, the Company issued shares of common stock for cash.
During the nine months ended September 30, 2023, the Company issued shares of common stock for rounding of shares related to the Reverse Split.
Stock-Based Compensation
The Company adopted an Employee, Director and Consultant Stock Plan on June 17, 2016 (the “2016 Plan”). Pursuant to the 2016 Plan, the Company’s Compensation Committee may grant awards to any employee, officer, director, consultant, advisor or other individual service provider of the Company or any subsidiary. Due to an annual “evergreen” provision in the 2016 Plan, the number of shares reserved for future grants was increased by , and in 2024, 2023 and 2022, respectively. As a result of these increases, as of September 30, 2024 and December 31, 2023, the aggregate number of shares of common stock available for awards under the 2016 Plan was shares and shares, respectively. Options issued under the 2016 Plan are exercisable for up to ten years from the date of issuance.
There were options outstanding as of September 30, 2024. During the three and nine months ended September 30, 2024, the Company issued options and options, respectively. During the three and nine months ended September 30, 2023, the Company issued options.
There were options outstanding as of December 31, 2023.
| Exercise price | $ | -$ | ||
| Expected dividend yield | % | |||
| Risk free interest rate | %- | % | ||
| Expected life in years | ||||
| Expected volatility | - | % |
| Number | Weighted Average Exercise Price | Weighted Average Remaining Life | ||||||||||
| Stock Options | ||||||||||||
| Outstanding December 31, 2023 | $ | |||||||||||
| Granted | ||||||||||||
| Expired | ( | ) | - | |||||||||
| Exercised | - | |||||||||||
| Outstanding September 30, 2024 | $ | |||||||||||
| 12 |
| Nonvested Options | Options | Weighted-Average Exercise Price | ||||||
| Nonvested at December 31, 2023 | $ | |||||||
| Granted | ||||||||
| Vested | ( | ) | ||||||
| Forfeited | ||||||||
| Nonvested at September 30, 2024 | $ | |||||||
As of September 30, 2024, the Company had shares issuable under options outstanding at a weighted average exercise price of $ and an intrinsic value of $.
The Company recognized compensation expense related to options issued of $ and $ for the three months ended September 30, 2024 and 2023, respectively, in which $ and $ is included in general and administrative expenses and $ and $ in research and development expenses, respectively. For the three months ended September 30, 2024 and 2023, $ and $ of the stock compensation was related to employees and $ and $ was related to non-employees, respectively.
The Company recognized compensation expense related to options issued of $ and $ for the nine months ended September 30, 2024 and 2023, respectively, in which $ and $ is included in general and administrative expenses and $ and $ in research and development expenses, respectively. For the nine months ended September 30, 2024 and 2023, $ and $ of the stock compensation was related to employees and $ and $ was related to non-employees, respectively.
As of September 30, 2024, the unamortized stock option expense was $ with $ being related to employees and $ being related to non-employees. As of September 30, 2024, the weighted average remaining vesting period for the unamortized stock compensation to be recognized is years.
On January 8, 2024, the Company issued options to purchase the Company’s common stock to consultants and employees. These options have an exercise price of $ and expire in years from issuance. These options vest over .
On
February 12, 2024, the Company entered into a consulting agreement. As part of this agreement the Company agrees to pay $
On March 25, 2024, the Company issued options to purchase the Company’s common stock to officers, board of directors and consultants. These options have an exercise price of $ and expire in years from issuance. These options vest between and months with options to vest upon achievement of certain performance conditions.
Warrants:
A summary of warrant issuances are as follows:
| Number | Weighted Average Exercise Price | Weighted Average Remaining Life | ||||||||||
| Warrants | ||||||||||||
| Outstanding December 31, 2023 | $ | |||||||||||
| Granted | - | |||||||||||
| Expired | - | |||||||||||
| Exercised | - | |||||||||||
| Outstanding September 30, 2024 | $ | |||||||||||
| 13 |
As of September 30, 2024, the Company had shares issuable under warrants outstanding at a weighted average exercise price of $ and an intrinsic value of $.
The Company recognized compensation expense related to warrants issued of $ and $ during the three ended September 30, 2024 and 2023, respectively. The Company recognized compensation expense related to warrants issued of $ and $ during the nine ended September 30, 2024 and 2023, respectively.
NOTE 6 - COLLABORATIVE AGREEMENTS
The Company and the University of Toronto (the “University”) entered into an agreement effective April 1, 2014 (the “New Research Agreement”) for the performance of a research project titled “Teneurin C-terminal Associated Peptide (“TCAP”) mediated stress attenuation in vertebrates: Establishing the role of organismal and intracellular energy and glucose regulation and metabolism” (the “New Project”). The New Project is to perform research related to work done by Dr. David A. Lovejoy, a professor at the University and stockholder of the Company, in regard to TCAP mediated stress attenuation in vertebrates: Establishing the role of organismal and intracellular energy and glucose regulation and metabolism. In addition to the New Research Agreement, Dr. Lovejoy entered into an agreement with the University in order to commercialize certain technologies. The New Research Agreement expired on March 30, 2016. In February 2017, the New Research Agreement was extended to December 31, 2017. The extension allowed for further development of the technologies and use of their applications. On April 10, 2018, the agreement was amended and the research agreement has been further extended to September 30, 2024. As of the dated of this filing, this agreement has not been extended.
The
sponsorship research and development expenses pertaining to the Research Agreements were $
NOTE 7 - COMMITMENTS AND CONTINGENCIES
Licensing Agreements
On July 31, 2005, the Company had entered into a Technology License Agreement (“License Agreement”) with the University pursuant to which the University agreed to license to the Company patent rights and other intellectual property, among other things (the “Technologies”). The Technology License Agreement was amended on February 18, 2015 and currently does not provide for an expiration date.
Pursuant
to the License Agreement and its amendment, the Company obtained an exclusive worldwide license to make, have made, use, sell and import
products based upon the Technologies, or to sublicense the Technologies in accordance with the terms of the License Agreement and amendment.
In consideration, the Company agreed to pay to the University a royalty payment of
In
the event the Company fails to provide the University with semi-annual reports on the progress or fails to continue to make reasonable
commercial efforts towards obtaining regulatory approval for products based on the Technologies, the University may convert our exclusive
license into a non-exclusive arrangement. Interest on any amounts owed under the License Agreement and amendment will be at
| 14 |
The patent applications were made in the name of Dr. Lovejoy and other inventors, but the Company’s exclusive, worldwide rights to such patent applications are included in the License Agreement and its amendment with the University. The Company maintains exclusive licensing agreements and it currently controls the five intellectual patent properties.
Legal Proceedings
From time to time we may be named in claims arising in the ordinary course of business. Currently, no legal proceedings, government actions, administrative actions, investigations or claims are pending against us or involve us that, in the opinion of our management, could reasonably be expected to have a material adverse effect on our business and financial condition.
Notice of Delisting
On July 24, 2024, the Company received a deficiency letter (the “Notification Letter”) from the Nasdaq Listing Qualifications (“Nasdaq”) stating that it is not in compliance with the minimum bid price requirements set forth in Nasdaq Listing Rule 5550(a)(2) for continued listing on The Nasdaq Capital Market. Nasdaq Listing Rule 5550(a)(2) requires listed securities to maintain a minimum bid price of $1.00 per share, and Nasdaq Listing Rule 5810(c)(3)(A) provides that a failure to meet the minimum bid price requirement exists if the deficiency continues for a period of 30 consecutive business days. Based on the closing bid price of the Company’s common stock for the 30 consecutive business days prior to the date of the Notification Letter, the Company no longer meets the minimum bid price requirement. The Notification Letter has no immediate effect on the listing or trading of the Company’s common stock on the Nasdaq Capital Market and, at this time, the common stock will continue to trade on the Nasdaq Capital Market under the symbol “PTIX”.
The Notification Letter states that the Company has 180 calendar days, or until January 20, 2025, to regain compliance with Nasdaq Listing Rule 5550(a)(2). To regain compliance, the Company’s closing bid price of the Company’s common stock must have a closing bid price of at least $1.00 for a minimum of ten consecutive business days.
The letter further states that in the event the Company does not regain compliance by January 20, 2025, the Company may be eligible for an additional 180 days if it meets the continued listing requirement for market value of publicly held shares and all other initial listing standards for Nasdaq, with the exception of the bid price requirement, and will need to provide written notice of its intention to cure the deficiency during the second compliance period. If the Company does not qualify for the second compliance period or fails to regain compliance during the second compliance period, Nasdaq will provide written notification to the Company that its common stock is subject to delisting. At that time, the Company may appeal the delisting determination to a hearings panel pursuant to the procedures set forth in the applicable Nasdaq Listing Rules. However, there can be no assurance that, if the Company does appeal the delisting determination by Nasdaq to the panel, such appeal would be successful.
NOTE 8 – RELATED PARTY TRANSACTIONS
The Company is provided free office space consisting of a conference room by the Company Executive Chairman, Dr. Armen. The Company does not pay any rent for the use of this space. This space is used for quarterly board meetings and our annual shareholder meeting.
During
the year ended December 31, 2021, the Company engaged Agenus Inc., a related party, to perform research and development services. Agenus
Inc. is a related party due to the Company’s Director and Chairman of the Board being the CEO and Chairman of the Board for Agenus
Inc. The Company incurred $
During
the year ended December 31, 2022, the Company engaged CTC North, GmbH (“CTC”) to perform research and development services.
CTC is a related party due to the Company’s Director and Chairman of the Board being the CEO and Chairman of the Board for Agenus
Inc, CTC’s parent company. The total commitment for this agreement is $
NOTE 9 – SUBSEQUENT EVENTS
On
October 29, 2024, Protagenic Therapeutics, Inc. (the “Company”) entered into a Securities Purchase Agreement (the “Purchase
Agreement”) with certain institutional investors (the “Purchasers”), pursuant to which the Company agreed to issue
to the Purchasers in a private placement, shares of the Company’s common stock (the “Shares”), par value
$ per share (“Common Stock”), series A common stock purchase
warrants (the “Series A Common Stock Warrants”) to purchase an aggregate of shares of Common Stock (the “Series
A Common Stock Warrant Shares”) with an exercise price of $
Brookline Capital Markets, a division of Arcadia Securities, LLC (“Brookline”),
acted as sole placement agent for the Transaction. The Company issued to Brookline or its designees warrants (the “Placement Agent
Warrants”) to purchase up to
The
Purchase Agreement closed on November 4, 2024. The Company sold (a) shares
of Common Stock, (b) series A common stock purchase warrants to purchase an aggregate of shares
of Common Stock, (c) series B common stock purchase warrants to purchase an aggregate of shares
of Common Stock and (d) placement agent warrants to purchase an aggregate of
| 15 |
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operation
Forward-Looking Statements
This quarterly report on Form 10-Q contains forward-looking statements within the meaning of the federal securities laws and the Private Securities Litigation Reform Act of 1995. These forward-looking statements can be identified by the use of forward-looking terminology such as “may,” “will,” “expect,” “intend,” “anticipate,” “estimate,” “believe,” “continue,” “identify” or other similar words or the negatives thereof. These may include our financial estimates and their underlying assumptions, statements about plans, objectives, intentions and expectations. Such forward-looking statements are subject to various risks and uncertainties. Accordingly, there are or will be important factors that could cause actual outcomes or results to differ materially from those indicated in such statements. We believe these factors include but are not limited to those described under the section entitled “Risk Factors” in our prospectus and our Annual Report on form 10-K for the year ended December 31, 2023, and any such updated factors included in our periodic filings with the SEC, which are accessible on the SEC’s website at www.sec.gov. These factors should not be construed as exhaustive and should be read in conjunction with the other cautionary statements that are included in this document (or our prospectus and other filings). Except as otherwise required by federal securities laws, we undertake no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future developments or otherwise.
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS
This Quarterly Report on Form 10-Q and other written and oral statements we make from time to time contain certain “forward-looking” statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 (the “Exchange Act”). You can identify these forward-looking statements by the fact they use words such as “could,” “expect,” “anticipate,” “estimate,” “target,” “may,” “project,” “guidance,” “intend,” “plan,” “believe,” “will,” “potential,” “opportunity,” “future” and other words and terms of similar meaning and expression in connection with any discussion of future operating or financial performance. You can also identify forward-looking statements by the fact that they do not relate strictly to historical or current facts. Such forward-looking statements are based on current expectations and involve inherent risks and uncertainties, including factors that could delay, divert or change any of them, and could cause actual outcomes to differ materially from current expectations. These statements relate to, among other things, our business strategy, our research and development, our product development efforts, our ability to commercialize our product candidates, the activities of our licensees, our prospects for initiating partnerships or collaborations, the timing of the introduction of products, the effect of new accounting pronouncements, uncertainty regarding our future operating results and our profitability, anticipated sources of funds as well as our plans, objectives, expectations, and intentions.
We have included more detailed descriptions of these risks and uncertainties and other risks and uncertainties applicable to our business that we believe could cause actual results to differ materially from any forward-looking statements in Part II-Item 1A “Risk Factors” of this Quarterly Report on Form 10-Q. We encourage you to read those descriptions carefully. Although we believe we have been prudent in our plans and assumptions, no assurance can be given that any goal or plan set forth in forward-looking statements can be achieved. We caution investors not to place significant reliance on forward-looking statements contained in this document; such statements need to be evaluated in light of all the information contained in this document. Furthermore, the statements speak only as of the date of this document, and we undertake no obligation to update or revise these statements.
| 16 |
The discussion and analysis of our financial condition and results of operations are based on our financial statements, which we have prepared in accordance with U.S. generally accepted accounting principles. The preparation of these financial statements requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the financial statements, as well as the reported revenues and expenses during the reporting periods. On an ongoing basis, we evaluate such estimates and judgments, including those described in greater detail below. We base these estimates on historical experience and on various other factors that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions.
We expect to continue to incur significant expenses and minimal positive net cash flows from operations or negative net cash flows from operations for the foreseeable future, and those expenses and losses may fluctuate significantly from quarter-to-quarter and year-to-year. We anticipate that our expenses will fluctuate substantially as we:
| ● | continue our ongoing preclinical studies, clinical trials and our product development activities for our pipeline of product candidates; | |
| ● | seek regulatory approvals for any product candidates that successfully complete clinical trials; | |
| ● | continue research and preclinical development and initiate clinical trials of our other product candidates; | |
| ● | seek to discover and develop additional product candidates either internally or in partnership with other pharmaceutical companies; | |
| ● | adapt our regulatory compliance efforts to incorporate requirements applicable to marketed products; | |
| ● | maintain, expand and protect our intellectual property portfolio; and | |
| ● | incur additional legal, accounting and other expenses in operating as a public company. |
Overview
Our proprietary, patent-protected, first-in-class lead compound, PT00114, is a synthetic form of Teneurin Carboxy-terminal Associated Peptide (“TCAP”), an endogenous brain signaling peptide that can dampen overactive stress responses. Our preclinical models have demonstrated efficacy of PT00114 in animal models of depression, anxiety, substance abuse & addiction, and PTSD.
PT00114 leverages a completely novel mechanism of action. Protagenic owns exclusive, worldwide rights to PT00114 through its license agreement with the University of Toronto and has an exclusive right to license additional intellectual property generated by Dr. David Lovejoy’s lab at University of Toronto. Additionally, the company is engaged in the research & development of follow-on compounds in the TCAP family. Extensive publications in peer-reviewed scientific journals underline the central role stress plays in the onset and proliferation of neuropsychiatric disorders like depression, anxiety, substance abuse & addiction, and PTSD. The mechanism of action of TCAP suggests that it counterbalances stress overdrive at the cellular level within the brain’s stress response cascade. TCAP works to alleviate the harmful behavioral, biochemical, and physiological effects of these disorders, while simultaneously restoring brain health. This mechanism has been corroborated in preclinical animal models of the psychiatric disorders listed above. Preclinical experiments required for IND filing have been completed. The Company is in the process of answering regulatory questions in the US and Germany.
On September 26, 2023, we announced the commencement of the Phase I/IIa clinical trial for PT00114. The trial aims to evaluate the therapeutic potential of PT00114 in treating an array of neuro-psychiatric conditions, including depression, anxiety, and PTSD. Phase I will recruit 56 subjects, randomized to undergo subcutaneous injections of either PT00114 or a placebo. The Phase I/IIa study will assess both healthy volunteers and patients diagnosed with Treatment-Resistant Depression, PTSD, and Generalized Anxiety Disorder. Besides monitoring disease status, the trial will gauge disease response by measuring biomarkers, such as circulating cortisol levels before and after treatment.
| 17 |
Results of Operations
We are a development stage company currently performing clinical trials to obtain Food and Drug Administration (“FDA”) approval and commercialization of our product.
During the three months ended September 30, 2024, we incurred a loss from operations of $652,066 as compared to $1,431,712 for the three months ended September 30, 2023. The decrease in the loss is from a decrease in research and development expense of $799,678 from $1,124,030 for the three months ended September 30, 2023 to $324,352 for the three months ended September 30, 2024, a decrease in general and administrative expenses of $19,800 from $307,682 for the three months ended September 30, 2023 to $287,882 for the three months ended September 30, 2024, offset by an increase in research and development expenses from related parties of $39,832 from $0 for the three months ended September 30, 2023 to $39,832 for the three months ended September 30, 2024.
During the nine months ended September 30, 2024, we incurred a loss from operations of $4,057,772 as compared to $3,314,748 for the nine months ended September 30, 2023. The increase in the loss is from an increase in research and development expense of $929,813 from $2,051,685 for the nine months ended September 30, 2023 to $2,981,498 for the nine months ended September 30, 2024, an increase in general and administrative expenses of $12,485 from $1,006,308 for the nine months ended September 30, 2023 to $1,018,793 for the nine months ended September 30, 2024, offset by a decrease in research and development expenses from related parties of $199,274 from $256,755 for the nine months ended September 30, 2023 to $57,481 for the nine months ended September 30, 2024.
The increase in R&D expense is due to our clinical trials moving forward causing an increase in related expenses. This increase has been the primary driver of our increased loss from operations for both the three and nine months ended September 30, 2024 compared to the same period for 2023.
Liquidity and Going Concern
We continually project anticipated cash requirements, predominantly from the ongoing funding requirements of our neuropeptide drug development program. The majority of these costs relate to paying external vendors such as Contract Research Organizations, peptide synthesizer companies, and new drug development. As of September 30, 2024, we had cash of $1,055,805 and working capital of $633,389. We anticipate further losses from the development of our business. Based on its cash resources as of September 30, 2024, the Company does not have sufficient resources to fund its operations past twelve months from the date these consolidated financial statements are available to be issued. Absent generation of sufficient revenue from the execution of the Company’s business plan, the Company will need to obtain debt or equity financing by the third quarter of 2025. Because of these factors, the Company believes that there is substantial doubt in the Company’s ability to continue as a going concern. These financial statements do not include any adjustments to the recoverability and classification of recorded asset amounts and classification of liabilities that might be necessary should the Company be unable to continue as a going concern.
Operating activities used $3,396,726 and $2,559,342 in cash for the nine months ended September 30, 2024 and 2023, respectively. The use of cash in operating activities during the nine months ended September 30, 2024, primarily comprised of $3,971,601 net loss, $37,715 in depreciation expense, $677,703 in stock compensation expense, realized gain on sale of marketable securities of $51,732, a decrease in prepaid expenses of $222,879, and a $134,068 increase of accounts payable and accrued expenses for both related parties and non-related parties, which included payments to legal and accounting professionals, payments to consultants, and other administrative expenses.
Investing activities provided $2,802,880 and $2,497,407 in cash during the nine months ended September 30, 2024 and 2023, respectively. The cash provided by investing activities was from $3,100,000 sale of marketable securities, offset by $297,120 used in the purchase of marketable securities the nine months ended September 30, 2024.
Financing activities provided $361,490 and $0 in cash during the nine months ended September 30, 2024 and 2023, respectively. The cash provided by financing activities was from the sale of common stock.
Item 3. Quantitative and Qualitative Disclosures about Market Risk.
Not applicable.
| 18 |
Item 4. Controls and Procedures
Disclosure Controls and Procedures
Evaluation of disclosure controls and procedures
Under the supervision and with the participation of our management, including our principal executive officer and principal financial officer, we conducted an evaluation of our disclosure controls and procedures, as such term is defined under Rule 13a-15(e) and Rule 15d-15(e) promulgated under the Securities Exchange Act of 1934 (the “Exchange Act), as of September 30, 2024. Based on this evaluation, we have identified material weaknesses in our internal control over financial reporting. Due to material weaknesses, our principal executive officer and principal financial officer concluded that our disclosure controls and procedures are not effective to ensure that information required to be disclosed by us in the reports we file or submit under the Exchange Act, including this Quarterly Report on Form 10-Q, is recorded, processed, summarized, and reported within the time periods specified in the SEC’s rules and forms and that our disclosure and controls are not designed to ensure that information required to be disclosed by us in the reports that we file or submit under the Exchange Act is accumulated and communicated to our management, including our principal executive and principal financial officer, or persons performing similar functions, as appropriate to allow timely decisions regarding required disclosure.
Material Weakness in Internal Control Over Financial Reporting
A material weakness is a deficiency, or combination of deficiencies, in internal control over financial reporting, such that there is a reasonable possibility that a material misstatement of the Company’s annual or interim financial statements will not be prevented or detected on a timely basis.
The material weaknesses we identified are described below:
| 1) | We do not have sufficient segregation of duties within accounting functions, which is a basic internal control. Due to our size and nature, segregation of all conflicting duties may not always be possible and may not be economically feasible. However, to the extent possible, the initiation of transactions, the custody of assets and the recording of transactions should be performed by separate individuals. Management evaluated the impact of our failure to have segregation of duties on our assessment of our disclosure controls and procedures and has concluded that the control deficiency that resulted represented a material weakness. | |
| 2) | Limited level of multiple reviews among those tasked with preparing the financial statements. |
These material weaknesses could result in a material misstatement to the annual or interim consolidated financial statements that would not be prevented or detected.
Remediation Plan
To address the material weakness described above the Company has engaged an independent third party to enhance our segregation of duties.
Since we remain a small Company, with limited segregation of duties, the third party has identified certain areas where we can layer in added controls and procedures. Management intends to implement such controls and procedures in the future.
A control system, no matter how well conceived and operated, can provide only reasonable, not absolute assurance that the objectives of the control system are met. The design of any system of controls is also based in part on certain assumptions regarding the likelihood of certain events, and there can be no assurance that any design will succeed in achieving its stated goals under all potential future conditions. Given these and other inherent limitations of control systems, these are only reasonable assurances that our controls will succeed in achieving their stated goals under all potential future conditions.
| 19 |
Changes in Internal Control over Financial Reporting
Other than as discussed above, there were no changes in our internal controls over financial reporting that occurred during the quarter covered by this Report that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
Part II: Other Information
Item 1. Legal Proceedings
From time to time we may be named in claims arising in the ordinary course of business. Currently, no legal proceedings, government actions, administrative actions, investigations or claims are pending against us or involve us that, in the opinion of our management, could reasonably be expected to have a material adverse effect on our business and financial condition.
Item 1A. Risk Factors
Our business is subject to substantial risks and uncertainties. Investing in our securities involves a high degree of risk. You should carefully consider the risk factors in Part I, Item 1A of our Annual Report on Form 10-K for the year ended December 31, 2023, filed with the SEC on April 1, 2024, together with the information contained elsewhere in this report, including Part I, Item 1 “Financial Statements” and Part I, Item 2. “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” and in our other SEC filings in evaluating our business. These risks and uncertainties could materially and adversely affect our business, financial condition, results of operations, prospects for growth, and the value of an investment in our securities.
There were no material changes to the risk factors previously disclosed in our Annual Report on Form 10-K for the year ended December 31, 2023, filed with the SEC on April 1, 2024.
Item 2. Unregistered Sale of Equity Securities and Use of Proceeds
None.
Item 3. Defaults upon Senior Securities
None.
Item 4. Mine Safety Disclosures
Not applicable.
Item 5. Other Information
None.
Item 6. Exhibits
The following is a complete list of exhibits filed as part of this Form 10-Q. Exhibit numbers correspond to the numbers in the Exhibit Table of Item 601 of Regulation S-K.
| Exhibit | Description | |
| 31.1 | Chief Executive Officer Certification as required under section 302 of the Sarbanes Oxley Act (€) | |
| 31.2 | Chief Financial Officer Certification as required under section 302 of the Sarbanes Oxley Act (€) | |
| 32.1 | Chief Executive Officer and Chief Financial Officer Certification pursuant to 18 U.S.C. section 1350 as adopted pursuant to section 906 of the Sarbanes Oxley Act * | |
| 101.INS | Inline XBRL Instance Document (€) | |
| 101.CAL | Inline XBRL Taxonomy Extension Schema Document (€) | |
| 101.SCH | Inline XBRL Taxonomy Extension Calculation Linkbase Document (€) | |
| 101.LAB | Inline XBRL Taxonomy Extension Label Linkbase Document (€) | |
| 101.PRE | Inline XBRL Taxonomy Extension Presentation Linkbase Document (€) | |
| 101.DEF | Inline XBRL Taxonomy Extension Definition Linkbase Document (€) | |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) |
(€) - Filed herewith.
(*) -Furnished, not filed, in accordance with item 601(32)(ii) of Regulation S-K.
| 20 |
SIGNATURES
Pursuant to the requirements of Section 12 of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
| November 14, 2024 | Protagenic Therapeutics, Inc. | |
| By: | /s/ Alexander K. Arrow | |
| Chief Financial Officer | ||
| 21 |