美國
證券及交易委員會
華盛頓特區20549

表格 10-Q

（標記一）

截止季度結束日期：2024年9月30日

過渡期從__________到__________

委託文件編號：001-39866001-39015

BIOVIE公司。

(根據其章程規定的註冊人準確名稱)

根據1933年證券法第12(b)條款註冊的證券:

根據證券法第12(g)條註冊的證券

無

如果申報人符合《證券法》第405條規定的知名老練發行人，請用複選標記表示。

是的 ☐No ☒

如果註冊人不需要根據法案第13條或第15條(d)的規定提交報告，請用複選標記表示。

是的 ☐No ☒

請通過勾選方式指明註冊人（1）在過去12個月（或註冊人需要提交此類報告的較短期間）是否已提交《交易所法》第13條或第15(d)條所要求的所有報告，以及（2）在過去90天內是否受到此類提交要求的約束。

是 ☒No ☐

請用複選標記表示，登記者在過去12個月（或登記者要求提交此類文件的更短時期）期間是否按照S-t規定第405條（本章第232.405條）要求提交了每個互動數據文件。

是 ☒No ☐

請選擇相應的複選框以指示註冊人是大型加速歸檔者、加速歸檔者、非加速歸檔者、小型報告公司還是新興增長型公司。請參閱《交易所法》第12億.2規則中「大型加速歸檔者」、「加速歸檔者」、「小型報告公司」和「新興增長型公司」的定義。

如果公司是新興成長型公司，請在選中的方框內打勾，以表示公司已選擇不使用根據交易法第13(a)條規定提供的任何新的或修訂的財務會計準則的延長過渡期來符合這些新的或修訂的財務會計準則。 ☐

如已註冊，請用複選標記表示，是否已根據《薩班斯—豪利法案》第404(b)條款（15 U.S.C.7362(b)）提交管理層對其內部財務報告制度有效性的評估報告，由準備或發佈其審計報告的註冊會計師事務所進行審定。

是的 ☐No ☒

如果證券根據證券法案第12(b)條註冊，請在複選框中標明，註冊人所提交的財務報表是否反映了以前發佈的財務報表的更正。 ☐

 ☐

請勾選註冊人是否爲殼公司（根據交易法第120億.2條的定義）。

是的 ☐                                          否 ☒

截至2023年7月31日，續借貸款協議下未償還的借款額爲17,768,174 2024年11月7日現有的註冊人的A類普通股股份0.0001美元每股。

目錄

BIOVIE公司。

前瞻性聲明

本報告包含根據1934年證券交易法第21E節和修正後的1933年證券法第27A節(「證券法」)的前瞻性聲明。本報告中包含的任何非歷史事實聲明均可能屬於前瞻性聲明。當我們使用「意圖」、「估計」、「預測」、「潛在」、「持續」、「預期」、「計劃」、「期望」、「相信」、「應該」、「可能」、「將」或這些術語的否定或其他類似術語時，我們正在確定前瞻性聲明。前瞻性聲明涉及風險和不確定性，這可能導致我們的實際結果、業績或成果與前瞻性聲明中表達或暗示的結果大相徑庭。這些因素包括我們的研發活動、分銷渠道、遵守監管強制性規定以及資本需求。儘管我們認爲前瞻性聲明中體現的期望是合理的，但我們無法保證未來的結果、活動水平、業績或成就。

除非適用法律要求，我們不進行更新或修訂前瞻性陳述的意圖，也不承擔更新任何此報告中包含的前瞻性陳述的義務，也不承擔由新信息或未來事件或情況導致前瞻性陳述的更新義務。因此，您不應假定我們在某段時間內保持沉默意味着實際事件的發展結果如同這些前瞻性陳述所表達或暗示的。您應該仔細審閱和考慮我們在此報告中以及在《交易所證券交易委員會》（「委員會」）提交的其他報告中所進行的各種披露，這些披露旨在告知相關各方可能影響我們業務的風險、不確定性和其他因素。

除了歷史事實陳述之外的所有陳述都可能被視爲前瞻性陳述。公司不承擔更新這些前瞻性陳述的義務，也不打算更新這些前瞻性陳述，除非法律要求。在本報告中使用時，「BioVie」、「公司」、「我們」以及「我們」指的是BioVie公司。

第一部分 - 財務信息

第 1 項。財務報表

BioVie股份有限公司。

簡明資產負債表

(未經審計)

請參閱不經審計的簡明財務報表附註

BioVie股份有限公司。

損益表和綜合損失簡明報表

(未經審計)

請參閱不經審計的簡明財務報表附註

BioVie股份有限公司。

股東權益變動簡明報表

(未經審計)

請參閱不經審計的簡明財務報表附註

BioVie股份有限公司。

現金流量簡明報表

(未經審計)

請參閱不經審計的簡明財務報表附註

BioVie股份有限公司。

基本財務報表附註。

截至2024年9月30日和2023年的三個月

(未經審計)

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

This report contains forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and Section 27A of the Securities Act of 1933, as amended. Any statements contained in this report that are not statements of historical fact may be forward-looking statements. When we use the words “intends,” “estimates,” “predicts,” “potential,” “continues,” “anticipates,” “plans,” “expects,” “believes,” “should,” “could,” “may,” “will” or the negative of these terms or other comparable terminology, we are identifying forward-looking statements. Forward-looking statements involve risks and uncertainties, which may cause our actual results, performance or achievements to be materially different from those expressed or implied by forward-looking statements. These factors include, among others: our research and development activities and distributor channel; compliance with regulatory requirements; and our ability to satisfy our capital needs Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance or achievements. 

You are cautioned not to place undue reliance on the forward-looking statements in this report, which speak only as of the date of this report. Except as may be required by applicable law, we do not undertake or intend to update or revise our forward-looking statements, and we assume no obligation to update any forward-looking statements contained in this report as a result of new information or future events or developments, except as required by law. Thus, you should not assume that our silence over time means that actual events are bearing out as expressed or implied in such forward-looking statements. You should carefully review and consider the various disclosures we make in this report and our other reports filed with the Securities and Exchange Commission (the “SEC”) that attempt to advise interested parties of the risks, uncertainties and other factors that may affect our business. 

The following discussion of the Company’s financial condition and the results of operations should be read in conjunction with the Financial Statements and Notes thereto appearing elsewhere in this report. 

Management’s Discussion

BioVie Inc. (the “Company” or “we” or “our”) is a clinical-stage company developing innovative drug therapies to treat chronic debilitating conditions including neurological and neuro-degenerative disorders and liver disease. 

Neurodegenerative Disease Program

The Company acquired the biopharmaceutical assets of NeurMedix, Inc. (“NeurMedix”) a privately held clinical-stage pharmaceutical company and a related party in June 2021. The acquired assets included NE3107. In April 2024, the Company announced that the United States Adopted Names Council, and the World Health Organization International Nonproprietary Names expert committee had approved “bezisterim” as the non-proprietary (generic) name for NE3107. Bezisterim (NE3107) is an investigational, novel, orally administered small molecule that is thought to inhibit inflammation-driven insulin resistance and major pathological inflammatory cascades with a novel mechanism of action. There is emerging scientific consensus that both inflammation and insulin resistance may play fundamental roles in the development of AD and PD, and bezisterim (NE3107) could, if approved by FDA, represent an entirely new medical approach to treating these devastating conditions affecting an estimated 6 million Americans suffering from AD and 1 million Americans suffering from PD.

In neurodegenerative disease, bezisterim (NE3107) inhibits activation of inflammatory ERK and nuclear factor kappa-light-chain-enhancer of activated B cells (“NFκB”) (including interactions with TNF signaling and other relevant inflammatory pathways) that lead to neuroinflammation and insulin resistance. Bezisterim (NE3107) does not interfere with their homeostatic functions (e.g., insulin signaling and neuron growth and survival). Both inflammation and insulin resistance are drivers of AD and PD.

Chronic neuroinflammation, insulin resistance, and oxidative stress are common features in the major neurodegenerative diseases, including AD, PD, frontotemporal lobar dementia, and Amyotrophic lateral sclerosis. Bezisterim (NE3107) is an investigational oral small molecule, blood-brain permeable, compound with potential anti-inflammatory, insulin sensitizing, and ERK-binding properties that may allow it to selectively inhibit ERK-, NFκB- and TNF-stimulated inflammation. Bezisterim’s (NE3107) potential to inhibit neuroinflammation and insulin resistance forms the basis for the Company’s work testing the molecule in AD, PD, and long COVID patients. Bezisterim (NE3107) is patented in the United States, Australia, Canada, Europe and South Korea.

Parkinson’s Disease

Parkinson’s disease (“PD”) is driven in large part by neuroinflammation and activation of brain microglia, leading to increased proinflammatory cytokines (particularly TNF). Multiple daily administrations of levodopa (converted to dopamine in the brain) is the current standard of care treatment for this movement disorder. However, levodopa effectiveness diminishes over time necessitating increased dosage and prolonged daily administration leads to side effects of uncontrolled movements called levodopa-induced dyskinesia, commonly referred to as LID, which is exacerbated by high dose levodopa. Although levodopa provides symptomatic benefit, it does not slow PD progression.

The Phase 2 study of bezisterim (NE3107) for the treatment of PD (NCT05083260), completed in December 2022, was a double-blind, placebo-controlled, safety, tolerability, and pharmacokinetics study in PD participants treated with carbidopa/levodopa and bezisterim (NE3107). Forty-five patients with a defined L-dopa “off state” were randomized 1:1 to placebo: bezisterim (NE3107) 20 mg twice daily for 28 days. This trial was launched with two design objectives: 1) the primary objective was safety and a drug-drug interaction study as requested by the FDA to measure the potential for adverse interactions of bezisterim (NE3107) with carbidopa/ levodopa; and 2) the secondary objective was to determine if preclinical indications of promotoric activity and apparent enhancement of levodopa activity could be seen in humans. Both objectives were met.

To extend this Phase 2 data in progressed patients, the Company has designed a new Phase 2 study of bezisterim (NE3107) as a potential first line therapy to treat patients with new onset PD. In August 2024, the FDA authorized the protocol for this new study.

Long COVID Program

In April 2024, the Company announced the grant of a clinical trial award of up to $13.1 million from the U.S. Department of Defense (“DOD”), awarded through the Peer Reviewed Medical Research Program of the Congressionally Directed Medical Research Programs. In August 2024, U.S. Army Medical Research and Development Command, Office of Human Research Oversight (“OHRO”) approved the Company’s plan to evaluate bezisterim (NE3107) for the treatment of neurological symptoms that are associated with long COVID. and the FDA authorized our Investigational New Drug (“IND”) application for bezisterim (NE3107) allowing us to study a novel, anti-inflammatory approach or the treatment of the debilitating neurocognitive symptoms associated with long covid. The Company anticipates the trial to commence by early 2025.

Liver Disease Program

In liver disease, our investigational drug candidate BIV201 (continuous infusion terlipressin), which has been granted both FDA Fast Track designation status and FDA Orphan Drug status, is being evaluated and discussed after receiving guidance from the FDA regarding the design of Phase 3 clinical testing of BIV201 for the treatment of ascites due to chronic liver cirrhosis. BIV201 is administered as a patent-pending liquid formulation.

In June 2021, the Company initiated a Phase 2 study (NCT04112199) designed to evaluate the efficacy of BIV201 (terlipressin, administered by continuous infusion for two 28-day treatment cycles) combined with standard-of-care (“SOC”), compared to SOC alone, for the treatment of refractory ascites. The primary endpoints of the study are the incidence of ascites-related complications and change in ascites fluid accumulation during treatment compared to a pre-treatment period.

In March 2023, the Company announced enrollment was paused and that data from the first 15 patients treated with BIV201 plus SOC appeared to show at least a 30% reduction in ascites fluid during the 28 days after treatment initiation compared to the 28 days prior to treatment. The change in ascites volume was significantly different from those patients receiving SOC treatment. Patients who completed the treatment with BIV201 experienced a 53% reduction in ascites fluid, which was sustained (43% reduction) during the three months after treatment initiation as compared to the three-month pre-treatment period.

In June 2023, the Company requested and subsequently received guidance from the FDA regarding the design and endpoints for definitive clinical testing of BIV201 for the treatment of ascites due to chronic liver cirrhosis. The Company is currently finalizing protocol designs for the Phase 3 study of BIV201 for the treatment of ascites due to chronic liver cirrhosis.

While the active agent, terlipressin, is approved in the U.S. and in about 40 countries for related complications of advanced liver cirrhosis, treatment of ascites is not included in these authorizations. Patients with refractory ascites suffer from frequent life-threatening complications, generate more than $5 billion in annual treatment costs, and have an estimated 50% mortality rate within 6 to 12 months. The FDA has not approved any drug to treat refractory ascites.

Comparison of the three months ended September 30, 2024 to the three months ended September 30, 2023

Net loss

The net loss for the three months ended September 30, 2024 was approximately $4.2 million and as compared to the net loss of $10.7 million for the three months ended September 30, 2023. The net decrease of $6.5 million for the three months ended September 30, 2024 was comprised of a decrease in research and development expenses of $6.9 million, offset by increased selling, general and administrative expenses of approximately $132,000 and a decrease in other (expense) income, net of approximately $195,000.

Total operating expenses for the three months ended September 30, 2024 were approximately $4.1 million as compared to $10.9 million for the three months ended September 30, 2023. The net decrease of approximately $6.8 million for the three months ended September 30, 2024, was comprised of decreased research and development expenses of approximately $6.9 million primarily due to the completion of clinical trials in the prior fiscal year, offset by a net increase in selling general and administrative expenses of approximately $132,000, primarily attributed to increased legal expenses related to regulatory, patent filings and litigation related to the class action suit.

Research and Development Expenses

Research and development (“R&D”) expenses were approximately $2.0 million for the three months ended September 30, 2024, a decline of approximately $6.9 million from $8.9 million for three months ended September 30, 2023. The net decrease in R&D expenses of approximately $6.9 million is primarily attributed to the completion of clinical trials in the prior fiscal year ended June 30, 2024, causing decreased clinical trials expenses of $5.2 million, a decline in the clinical team expense consisting of reductions in clinical team payroll of approximately $915,000, reduction in the use of consultants of approximately $547,000, a reduction in the use of regulatory and other consultants totaling approximately $274,000, and a decrease in other related expenses of approximately $126,000 in travel, conferences and publications. This was offset by increased expenses in Chemistry, Manufacturing and Controls (“CMC”) totaling approximately $155,000 related to drug production and drug discovery development.

The decline in clinical studies of $5.2 million represented the net decrease in clinical trial studies expense due the completion of the clinical trials in fiscal year 2024 offset by the planning and development of the two new clinical studies PD and LC. The table below summarizes the expense amounts for the three months ended September 30, 2024 and 2023 by study:

Selling, General and Administrative Expenses

Selling, general and administrative expenses were approximately $2.1 million and $1.9 million for the three months ended September 30, 2024 and 2023, respectively. The net decrease of approximately $132,000 was primarily attributed to the increases in legal fee expenses of approximately $400,000 and insurance premiums of approximately $29,000; offset by declines in the executive teams compensation of approximately $188,000, investor relations and other filing fees of approximately $49,000, and other professional and consulting fees of approximately $52,000.

Other Income and Expense

Other expense, net was approximately $30,000 compared to other income, net of $165,000, for the three months ended September 30, 2024 and 2023, respectively. The net increase in other expense of approximately $195,000 is comprised of a reduction in the change in fair value of the related derivative liabilities of approximately $705,000 and a reduction in interest expense of approximately $749,000, offset by a reduction in interest income of approximately $239,000.

Capital Resources and Liquidity

As of September 30, 2024, the Company had working capital of approximately $13.3 million, cash and cash equivalents totaling approximately $20.0 million, stockholders’ equity of approximately $14.1 million, and an accumulated deficit of approximately $338.7 million.

The Company used net cash in operations totaling approximately $3.6 million and net cash provided by financing activities was approximately $241,000 comprised of net proceeds from capital raise activities of $2.3 million offset by the payment of $2.5 million of the Company’s notes payable.

The Company has not generated any revenue and no revenues are expected in the foreseeable future. The Company’s future operations are dependent on the success of the Company’s ongoing development and commercialization efforts, as well as its ability to secure additional financing. Management expects that future sources of funding may include sales of equity, obtaining loans, or other strategic transactions.

Although management continues to pursue the Company’s strategic plans, there is no assurance that the Company will be successful in obtaining sufficient financing on terms acceptable to the Company, if at all, to fund continuing operations. These circumstances raise substantial doubt on the Company’s ability to continue as a going concern. The financial statements do not include any adjustments that might result from the outcome of this uncertainty.

Controlled Equity Offering

During the three months ended September 30, 2024, the Company sold approximately 2,143 shares of its Common Stock under its Controlled Equity Offering Sales Agreement with Cantor Fitzgerald & Co for total net proceeds of approximately $6,400 after 3% commissions and offering costs totaling approximately $200. On September 25, 2024, the Company filed a prospectus supplement to suspend sales under the Controlled Equity Offering Sales Agreement.

Registered Direct Offerings 

On September 25, 2024, the Company closed a best efforts public offering (the “September 2024 Offering”) of 1,360,800 shares of its common stock, par value $0.0001 per share, pre-funded warrants (the “September Pre-funded Warrants”) to purchase 600,000 shares of Common Stock, and warrants to purchase up to 1,960,800 shares of Common Stock (the “September Common Warrants”) at a combined public offering price of $1.53 per Share, or September Pre-funded Warrant, and the associated September Common Warrant. 265,000 September Pre-funded Warrants were exercised in the three months ended September 30, 2024 and reflected on the condensed statement of changes in stockholders’ equity as a component of proceeds from issuance of common stock. The September Common Warrants have an exercise price of $1.53 per share and are immediately exercisable upon issuance and will expire on the fifth anniversary date of the original issuance date. The gross proceeds to the Company from the September 2024 Offering were approximately $3.0 million, before deducting placement agent fees and offering expenses of approximately $747,000. Additionally, upon closing, the Company issued the placement agent warrants (“September Placement Agent’s Warrants”) to purchase 98,040 shares of Common Stock exercisable at a per share price of $1.91, which was equal to 125% of the public offering price per share. The September Placement Agent’s Warrants are exercisable during a five-year period commencing 180 days from September 25, 2024. 

In October 2024, the Company closed three registered direct offerings totaling 8,256,000 shares of its common stock, par value $0.0001 per share, and two concurrent private placements of warrants to purchase up to 8,256,000 shares of Common Stock (the “October Common Warrants”) priced at-the-market under Nasdaq rules at prices ranging from $1.50 to $2.83 per share (the “October Offerings”). The October Common Warrants have exercise prices ranging from $1.37 to $2.83 per share and are exercisable beginning six months following issuance and will expire on the fifth anniversary date of the original issuance dates. The gross proceeds to the Company from the October Offerings totaled approximately $15.9 million, before deducting placement agent fees and offering expenses of approximately $2.8 million. Additionally, upon closing of the October Offerings the Company issued placement agent warrants (the “October Placement Agent’s Warrants”) to purchase 412,800 shares of Common Stock in the aggregate exercisable at a per share price ranging from $1.88 to $3.54, which was equal to 125% of the offering price per share in the applicable October Offering. The October Placement Agent’s Warrants are exercisable during a five-year period commencing 180 days from each of the respective closing dates of the October Offerings. 

Critical Accounting Policies and Estimates

For the three-month period ended September 30, 2024, the Company added a Grant Program accounting policy that is disclosed in the Significant Accounting Policies section of the 10-Q. There were no other significant changes to the Company’s critical accounting policies as identified in the Annual Report Form 10-K for the fiscal year ended June 30, 2024.

New Accounting Pronouncements

The Company considered the applicability and impact of recent accounting pronouncements and determined those to be either not applicable or expected to have minimal impact on our balance sheets or statement of operations and comprehensive loss.

Item 3. Quantitative and Qualitative Disclosures About Market Risk

Not applicable to smaller reporting companies.

Item 4. Controls and Procedures

We maintain “disclosure controls and procedures.” Such term is defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act that are designed to ensure that information required to be disclosed by us in reports that we file or submit under the Exchange Act is recorded, processed, summarized, and reported within the time periods specified in Securities and Exchange Commission rules and forms, and that such information is accumulated and communicated to our management, including our Chief Executive Office and Chief Financial officer, as appropriate, to allow timely decisions regarding required disclosure. In designing and evaluating our disclosure controls and procedures, management recognized that disclosure controls and procedures, no matter how well conceived and operated, can provide only reasonable, not absolute, assurance that the objectives of the disclosure controls and procedures are met. Our disclosure controls and procedures have been designed to meet reasonable assurance standards. Additionally, in designing disclosure controls and procedures, our management necessarily was required to apply its judgement in evaluating the cost-benefit relationship of possible disclosure and procedures. The design of and disclosure controls and procedures also are based in part upon certain assumptions about the likelihood of future events, and there can be no assurance that any design will succeed in achieving its stated goals under all potential future conditions.

Based on their evaluation as of the end of the period covered by this Quarterly Report on Form 10-Q, our Chief Executive Officer and Chief Financial Officer have concluded that, as of such date, our disclosure controls and procedures were effective at the reasonable assurance level, as appropriate, to allow timely decisions regarding required disclosure.

Changes in Internal Control over Financial Reporting

There were no changes in our internal control over financial reporting (as defined in Rule 13a-15f and 15d-15(f) under the Exchange Act) that occurred during the quarter ended September 30, 2024, 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

To our knowledge, other than described below, neither the Company nor any of its officers or directors is a party to any material legal proceeding or litigation and such persons know of no material legal proceeding or contemplated or threatened litigation, other than as described below. There are no judgments against us or our officers or directors. None of our officers or directors has been convicted of a felony or misdemeanor relating to securities or performance in corporate office.

On January 19, 2024, a purported shareholder class action complaint, captioned Eric Olmstead v. BioVie Inc. et al., No. 3:24-cv-00035, was filed in the U.S. District Court for the District of Nevada, naming the Company and certain of its officers as defendants. On February 22, 2024, a second, related putative securities class action was filed in the same court asserting similar claims against the same defendants, captioned Way v. BioVie Inc. et al., No. 2:24-cv-00361. On April 15, 2024, the court consolidated these two actions under the caption In re BioVie Inc. Securities Litigation, No. 3:24-cv-00035, appointed the lead plaintiff, and approved selection of the lead counsel. On June 21, 2024, the lead plaintiff filed an amended complaint, alleging that the defendants made material misrepresentations and/or omissions of material fact relating to the Company’s business, operations, compliance, and prospects, including information related to the NM101 Phase 3 study and trial of bezisterim (NE3107) in mild to moderate probable AD, in violation of Sections 10(b) and 20(a) of the Exchange Act, and Rule 10b-5 promulgated thereunder. The class action is on behalf of purchasers of the Company’s securities during the period from December 7, 2022 through November 28, 2023 and seeks unspecified monetary damages on behalf of the putative class and an award of costs and expenses, including attorney’s fees. The defendants filed a motion to dismiss the amended complaint on August 21, 2024, and plaintiffs filed their opposition on October 21, 2024. The defendants’ reply brief is due December 5, 2024. The defendants believe that the claims are without merit and intend to defend vigorously against them, but there can be no assurances as to the outcome.

Item 1A. Risk Factors

Except as described below, there have been no material changes to the Risk Factors previously disclosed in our Form 10-K. The risks described in our Form 10-K and below are not the only risks facing our company. Additional risks and uncertainties not currently known to us or that we currently deem to be immaterial also may materially adversely affect our business, financial condition, and/or operating results.

Risks Relating to Our Business and Industry

We rely and will continue to rely on third parties to conduct our clinical trials. If these third parties do not successfully carry out their contractual duties or meet expected deadlines or do not successfully perform and comply with regulatory requirements, we may not be able to obtain regulatory approval of or commercialize our product candidates.

我們依賴，並將繼續依賴於第三方，包括但不限於醫藥外包概念（「CROs」）、臨床試驗地點和臨床試驗首席研究員、合同實驗室、IRB、製造商、供應商以及其他第三方來進行我們的臨床試驗，包括我們藥物候選物bezisterim（NE3107）和BIV201的試驗。在臨床試驗期間，我們在很大程度上依賴這些第三方，而我們只控制他們活動的某些方面。不過，我們仍然對確保每項研究按照協議和適用的法律、監管和科學標準及規定進行最終負責，我們對第三方的依賴並未減輕我們的監管責任。我們和這些第三方都必須遵守cGCPs，這是FDA及可比的外國監管機構執行的關於臨床開發中藥物候選產品的臨床試驗的相關規定和指南。監管機構通過定期檢查和因故檢查來強制執行cGCPs。如果由於公司或第三方的失誤，臨床試驗未能遵循適用的cGCPs、FDA的IND要求、其他適用的監管要求或適用的IRB批准協議中列出的要求，公司可能需要進行額外的臨床試驗以支持我們的市場申請，這將延遲監管批准過程。例如，我們的藥物產品候選物bezisterim（NE3107）已獲得FDA批准，用於在輕度至中度AD的受試者中進行的第三階段隨機、雙盲、安慰劑對照、平行組、多中心研究。該試驗的入組於2021年8月開始，計劃於2022年底/2023年初完成。在2023年11月29日，公司公佈了其在輕度至中度AD治療中關於bezisterim（NE3107）的第三階段臨床試驗（NCT04669028）的初步有效性數據。在試驗完成時，隨着公司開始分析試驗數據，發現15個研究地點存在重大偏離協議和cGCP違規（幾乎所有研究地點均來自同一地理區域）。這一飛凡水平的疑似不當行爲促使公司排除了這些地點的所有患者。隨後，我們通知了FDA的OSI有關研究協議重大偏離、疑似不當行爲和相關研究地點的情況。對多個研究地點的研究協議重大偏離和大量GCP違規的識別引發了有關來自這些研究地點數據有效性和可靠性的問題。如此多患者的非計劃性排除使得試驗在其主要終點上缺乏統計能力。然而，基於在協議和GCP合規的其他研究地點的剩餘數據，初步檢測到了一種有效性信號。公司正在考慮：(1) 利用協議的適應性試驗特性繼續招募患者以達到統計顯著性；和/或 (2) 設計一個新階段的bezisterim（NE3107）第三階段研究，結合最新的與AD相關的科學文獻以及公司對bezisterim（NE3107）在輕度至中度AD患者中的作用的理解。

Although we design the clinical trials for our product candidates, our CROs are tasked with facilitating and monitoring these trials. As a result, many aspects of our clinical development programs, including site and investigator selection, and the conduct, timing, and monitoring of the study, is outside our direct control, either partially or in whole. Our reliance on third parties to conduct clinical trials also results in less direct control over the collection, management, and quality of data developed through clinical trials than would be the case if we were relying entirely upon our own employees. Communicating with third parties can also be challenging, potentially leading to mistakes as well as difficulties in coordinating activities. Our business may be impacted if any of these third parties violates applicable federal, state, or foreign laws and/or regulations, including but not limited to FDA’s IND regulations, cGCPs, fraud and abuse or false claims laws, healthcare privacy and data security laws, or provide us or government agencies with inaccurate, misleading, or incomplete data.

Adverse Developments Affecting the Financial Services Industry and Concentration of Risk

As of September 30, 2024, the Company had cash deposited in a certain financial institution in excess of federally insured levels. The Company regularly monitors the financial stability of the financial institution and believes that it is not exposed to any significant credit risk in cash and cash equivalents. Bank failures, events involving limited liquidity, defaults, non-performance, or other adverse developments that affect financial institutions, or concerns or rumors about such events, may lead to liquidity constraints. In 2023, certain U.S. government banking regulators took steps to intervene in the operations of certain financial institutions due to liquidity concerns, which caused general heightened uncertainties in financial markets. While previous bank failures have not had a material direct impact on the Company’s operations, if further liquidity and financial stability concerns arise with respect to banks and financial institutions, either nationally or in specific regions, the Company’s ability to access cash or enter into new financing arrangements may be threatened, which could have a material adverse effect on its business, financial condition and results of operations. 

Risks Relating To Our Common Stock

您可能會在未來的股本發行或者我們發行受期權、認股權證、股票獎勵或其他安排約束的股份時遭受未來攤薄。

截至2024年9月30日，根據經過修改的公司章程，我們授權發行8億股普通股，而我們已發行和流通中的普通股數量分別爲7,982,986股和7,956,660股。因此，我們可能再發行高達792,043,340股普通股。未來發行普通股可能導致我們現有股東所持有的普通股百分比大幅稀釋。我們未來可能根據任意基礎評估任何普通股。未來爲服務、收購或其他公司行動發行普通股可能會導致投資者持有的股份價值被稀釋，並可能對我們的普通股交易市場產生不利影響，並可能損害我們通過出售股權證券籌集資本的能力。

爲了籌集額外資金，我們可能在未來提供更多的普通股或其他可轉換成或可交換成我們普通股的證券。我們可能會以低於當前市場價格的每股價格出售股票或其他證券，而未來購買股票或其他證券的投資者可能會擁有優於現有股東的權利。出售我們普通股或其他可轉換成或可交換成我們普通股的額外股票將稀釋所有股東的權益，如果這些可轉換證券的銷售以較低於我們在2022年8月以當前行使價格出售給Acuitas Group Holdings, LLC（「Acuitas」）的warrants的視同發行價格進行，那麼這些warrants的行使價格將依據這些warrants中包含的價格調整保護向下調整至視同發行價格。

截至2024年9月30日，尚未行使的warrants總計可購買4,316,002股我們的普通股，行使價格範圍爲每股1.53美元至125.00美元，並且517,996股可以通過行使尚未行使的期權獲得，行使價格範圍爲每股4.70美元至420.90美元，以及總計34,566股的限制性股票單位。此外，根據於2021年11月30日與Avenue Venture Opportunities Fund II, L.P.和Avenue Venture Opportunities Fund, L.P.簽署的貸款和安防-半導體協議及其補充協議，貸款方有權將最多500萬的未償貸款金額轉換爲我們的普通股，轉換價格爲每股69.80美元。我們還可以授予額外的期權、warrants或股權獎勵。在這些股份發行的情況下，我們普通股持有人的利益將會被稀釋。

此外，根據2021年4月27日簽署的資產購買協議，公司、NeurMedix和Acuitas之間的關於我們某些藥物候選品（即bezisterim（NE3107）、NE3291、NE3413和NE3789）在臨床、監管和商業方面取得特定里程碑必須發行我們的普通股。自2021年5月9日修訂協議後，這些里程碑的達成可能導致最多180萬股我們的普通股發行，進一步稀釋我們普通股持有者的利益。

未註冊股權證券的銷售

2024年8月12日，公司發行了15,000股普通股給供應商作爲他們服務的一部分費用。發行日期普通股的公平價值爲每股2.23美元。與這次普通股發行相關的股權報酬費用爲33,450美元。

上述證券的報價、銷售和發行被認定爲根據《證券法》第4（a）（2）條的規定，在《證券法》或其根據指示的《D條例》下豁免註冊，作爲發行人不涉及公共發行的交易。 在這些交易中，證券的收件人僅出於投資目的而獲取證券，並且適當的標籤被貼在這些交易中發行的證券上。 這些交易中的每位證券收件人都是一位獲准的或精明的人，並且通過就業、業務或其他關係，可以獲得關於我們的信息。

除了上述交易中發行的股票證券 和我們於2024年10月22日向美國證券交易委員會提交的8-k表格以及2024年10月24日和2024年10月29日提交的最新報告中披露的交易之外，在此期間未發生任何未經註冊的股票證券銷售。

項目3. 面對高級證券的違約情況

無

項目4.礦山安全披露

無

項目5.其他信息

無

第 6 項。展品

(a) 展覽指數

展覽

簽名

根據第 13 或 15 (d) 節的要求 根據1934年《證券交易法》，註冊人已正式安排下列簽署人代表其簽署本報告 正式授權。

BioVie 公司。