BURLINGTON, Mass., May 01, 2024 (GLOBE NEWSWIRE) -- Minerva Neurosciences, Inc. (NASDAQ:NERV), a clinical-stage biopharmaceutical company focused on the development of therapies to treat central nervous system (CNS) disorders, today reported business updates and financial results for the first quarter of 2024 ending March 31, 2024. Roluperidone NDA Update On February 27, 2024, the Company announced that the U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) to its New Drug Appli ...

Financial Performance - The company reported an accumulated deficit of $405.4 million as of March 31, 2024, compared to $396.8 million as of December 31, 2023[70]. - For the three months ended March 31, 2024, the company recorded a net loss of $8.6 million, an increase from a net loss of $7.0 million for the same period in 2023[70]. - The company has not generated any revenue from the sales or licensing of its product candidates, and it anticipates continuing to incur net losses for the foreseeable future[70]. - Net cash used in operating activities for Q1 2024 was approximately $6.1 million, compared to $0.1 million in Q1 2023, primarily due to a net loss of $8.6 million[102][103]. - The company reported a net loss of $8.6 million for the three months ended March 31, 2024, which was higher than the net loss of $7.0 million for the same period in 2023[102][103]. - There were no cash flows from investing or financing activities during the three months ended March 31, 2024 and 2023, resulting in a net decrease in cash of $6.1 million for Q1 2024[101][104][105]. Expenses - Research and development expenses increased to $4.2 million for the three months ended March 31, 2024, up from $2.7 million in the same period in 2023, primarily due to costs associated with the FDA's review of the NDA and the MIN-101C18 study[83]. - General and administrative expenses decreased to $2.5 million for the three months ended March 31, 2024, down from $2.7 million in the same period in 2023, mainly due to lower professional service fees[84]. Cash Position - As of March 31, 2024, the company had approximately $34.9 million in cash, cash equivalents, and restricted cash, expected to meet operating commitments for the next 12 months[89]. - The company expects to finance its cash needs through equity offerings, debt financings, and collaborations, but additional funding may dilute existing stockholder interests[99]. - Existing cash, cash equivalents, and restricted cash are believed to be sufficient to meet cash commitments for at least the next 12 months[99]. Regulatory and Clinical Developments - The FDA issued a Complete Response Letter on February 26, 2024, citing clinical deficiencies in the NDA for roluperidone, requiring additional studies to support its safety and effectiveness[71]. - The company completed a Phase 1b clinical trial in Q1 2024, enrolling 17 patients to evaluate the safety and pharmacokinetics of roluperidone co-administered with olanzapine[74]. Funding Activities - The company raised $20.0 million in gross proceeds from a private placement of common stock and warrants on June 30, 2023[92]. - The company sold its royalty interest in seltorexant to Royalty Pharma for an upfront payment of $60 million, with potential future milestone payments of up to $95 million[96]. Accounting and Reporting - The company identified critical accounting policies related to research and development costs and the liability for the sale of future royalties as significant for its financial status[106]. - The company is classified as a "smaller reporting company," allowing it to take advantage of scaled disclosures as long as certain market value and revenue thresholds are met[108].

Financial Performance - The company incurred a net loss of $30.0 million for the fiscal year ended December 31, 2023, compared to a loss of $32.1 million in 2022, with an accumulated deficit of approximately $396.8 million as of the end of 2023[158]. - The company expects to continue incurring significant losses as it advances research and development for roluperidone and other product candidates, with future losses potentially increasing[159]. - As of December 31, 2023, the company had cash, cash equivalents, and restricted cash totaling $41.0 million, which is expected to meet cash commitments for at least the next 12 months[161]. - The company will require additional capital to finance operations and product development, with potential challenges in raising funds due to global economic conditions[162]. - The company has approximately $126.2 million in federal net operating losses (NOLs) as of December 31, 2023, with some NOLs beginning to expire in 2036 if not utilized[168]. - The company has no products approved for commercial sale and has not generated any revenue from product sales to date, indicating a high level of financial risk[158]. Regulatory Approval and Clinical Trials - The FDA has assigned a Prescription Drug User Fee Act (PDUFA) goal date of February 26, 2024, for the review of the NDA for roluperidone, following a previous refusal to file[157]. - The FDA filed the NDA for roluperidone on April 27, 2023, with a PDUFA goal date of February 26, 2024[174]. - The FDA identified potential review issues including the efficacy and safety of roluperidone in patients requiring antipsychotic treatment[174]. - The Phase 3 trial of roluperidone failed to meet its primary endpoint, despite the Phase 2b trial achieving statistical significance[178]. - Regulatory authorities may require additional studies or data, which could increase costs and delay the approval process[174]. - The company has no experience in advancing product candidates beyond Phase 3, which complicates the assessment of its commercialization capabilities[186]. - Enrollment challenges in clinical trials may arise due to the mental health conditions of subjects, impacting timely completion[187]. - The results of clinical trials conducted outside the U.S. may not be accepted by the FDA, potentially necessitating additional trials[179]. - The company may face significant setbacks in clinical trials due to safety or efficacy concerns, which are common in the pharmaceutical industry[178]. - Regulatory approval processes may be impacted by government funding issues or global health concerns, affecting review times[184]. - The company has previously discontinued development of MIN-117 for MDD after failing to achieve its primary endpoint in a Phase 2b trial[188]. - The company is prioritizing the development of its most advanced product candidate, roluperidone, while suspending further development of MIN-301[191]. - Regulatory approval for product candidates may be delayed or granted for narrower indications than expected, impacting commercialization timelines[192]. - Approved products will be subject to ongoing regulatory obligations, which may result in significant expenses and limit commercialization capabilities[194]. - Changes in drug indications, labeling, or safety issues may require additional regulatory submissions, potentially delaying market entry[195]. - The regulatory pathway for MIN-301 has not yet been determined, and the company plans to discuss the appropriate regulatory requirements with the FDA[208]. - The European Commission's proposal to revise pharmaceutical legislation may decrease data and market exclusivity for product candidates in the EU[206]. - Compliance with the new EU Clinical Trials Regulation may impact development plans and timelines[205]. Market and Competitive Landscape - The biopharmaceutical industry is highly competitive, with major pharmaceutical companies and biotechnology firms posing significant challenges due to their greater resources[212]. - Competitors may achieve regulatory approval faster or develop more effective products, which could hinder the company's market position[213]. - The company currently has a limited marketing and sales organization, which may impede its ability to effectively commercialize approved products[218]. - If the company commercializes its product candidates, it may face unfavorable pricing regulations and reimbursement practices that could adversely affect revenue[225]. - Coverage and adequate reimbursement from third-party payors are critical for product acceptance, and any limitations could materially harm the company's business[229]. - The company anticipates that pricing negotiations in international markets may delay product launches and impact revenue generation[226]. - The introduction of cost-containment measures in the EU could lead to price reductions and affect the company's ability to recoup investments in product development[228]. - The U.S. federal government may impose mandatory additional rebates and discounts on drug manufacturers if commercial prices increase faster than the Consumer Price Index-Urban, potentially impacting the ability to raise commercial prices[232]. - Coverage and reimbursement for drug products in the U.S. can vary significantly among third-party payors, leading to a time-consuming and costly coverage determination process[233]. - There may be significant delays in obtaining coverage and reimbursement for newly approved drugs, which could adversely affect the commercialization of product candidates[235]. - The Inflation Reduction Act of 2022 allows HHS to negotiate prices for certain drugs under Medicare, which could significantly impact the pharmaceutical industry[237]. - The EU's Regulation No 2021/2282 on Health Technology Assessment, effective January 2025, aims to enhance cooperation among EU Member States in assessing health technologies, potentially affecting pricing and reimbursement[244]. - The legislative landscape in the U.S. and EU continues to evolve, with potential future measures that may impose more rigorous coverage criteria and lower reimbursement rates[241]. - The UK’s withdrawal from the EU may lead to additional regulatory challenges and costs for drug manufacturers, particularly regarding batch testing and release requirements[249]. - Currency fluctuations, especially with the Euro, could significantly impact the costs of conducting clinical trials in Europe[246]. - The company may face increased operational risks due to geopolitical instability and public health issues, which could adversely affect business prospects[247]. - The company may need to compile additional data for cost-effectiveness assessments in some EU Member States to obtain reimbursement for its products[243]. Legal and Compliance Risks - The company faces significant risks related to product liability claims, which could result in substantial liabilities and limit the commercialization of its product candidates[263]. - The company does not currently carry product liability insurance, which may hinder its ability to commercialize products if claims arise[264]. - The company actively evaluates strategic transactions and may pursue acquisitions or joint ventures, but lacks substantial experience in integrating acquired businesses[260]. - The potential divergence of UK legislation from EU regulations post-Brexit could materially impact the company's regulatory regime and development plans[252]. - The company may incur significant additional expenses due to delays in obtaining regulatory approvals, which could adversely affect its ability to generate revenue[253]. - The company is highly dependent on key personnel, and the loss of such individuals could harm its business and financial condition[254]. - The company must manage its growth effectively to maintain relationships with strategic partners and ensure successful commercialization of its product candidates[258]. - The company faces challenges in maintaining effective internal controls over financial reporting, which could affect investor confidence and stock value[267]. - The company is exposed to risks of employee misconduct, including non-compliance with FDA regulations, which could lead to significant penalties and reputational harm[272]. - Misconduct could result in civil, criminal, and administrative penalties, including possible exclusion from federal healthcare programs, which would adversely affect the company's operations[273]. - The company must comply with various healthcare laws, including the federal Anti-Kickback Statute and the False Claims Act, which could impact its sales and marketing activities[275]. - Non-compliance with healthcare laws may lead to penalties, reputational harm, and diminished profits, affecting future earnings and operational restructuring[274]. - The company is subject to the Foreign Corrupt Practices Act, which imposes strict accounting and compliance requirements for international operations[279]. - Data privacy and security obligations are stringent, with potential regulatory investigations and penalties for non-compliance, impacting business operations[280]. - The company faces significant fines under the California Consumer Privacy Act, which can reach up to $7,500 per intentional violation, complicating compliance efforts[282]. - The European Union's GDPR imposes fines of up to €20 million or 4% of annual global revenue for violations, increasing legal risks and compliance costs[285]. - Compliance with the Swiss Federal Act on Data Protection may lead to increased costs and risks of noncompliance penalties[286]. - The company may face significant adverse consequences if unable to lawfully transfer personal data from the EEA or UK, including increased regulatory exposure and potential fines[288]. - Compliance with data privacy and security obligations requires significant resources and may necessitate changes to information technologies and data processing practices[290]. Cybersecurity and Operational Risks - The company is subject to U.S. and foreign export controls, sanctions, and anti-corruption laws, which could impair its ability to compete in markets[294]. - Cyberattacks and malicious activities pose a threat to the confidentiality and integrity of sensitive information, with ransomware attacks becoming increasingly prevalent[298]. - The company relies on third-party service providers for critical business systems, which may expose it to cybersecurity risks and vulnerabilities[299]. - Security incidents could disrupt the company's ability to provide services and may lead to significant financial and reputational harm[302]. - The company must conduct clinical trials in compliance with Good Clinical Practices (GCP), and failure to do so could delay regulatory approvals[304]. - Regulatory authorities enforce GCP compliance through inspections, and any non-compliance could result in the need for additional clinical trials[304]. - The company may face substantial civil and criminal penalties for violations of data privacy and security laws, impacting its operations and reputation[295]. - The company’s contracts may not sufficiently limit liability related to data privacy and security obligations, and insurance coverage may be inadequate[303]. - The company relies on third-party contract research organizations (CROs) for clinical programs, which may lead to delays and impact clinical development timelines[305]. - If CROs fail to meet contractual obligations, it could result in extended or terminated clinical trials, increased costs, and delayed revenue generation[306]. - The company does not have its own manufacturing facilities and depends on third-party manufacturers, increasing the risk of insufficient product quantities or quality issues[307]. - Regulatory compliance and quality assurance are critical, as any noncompliance by third-party manufacturers could lead to significant operational disruptions[309]. - The company faces risks related to the potential noncompliance of suppliers with regulatory requirements, which could result in delays and market disruptions[310]. Intellectual Property and Market Position - The company has a license agreement with Mitsubishi Tanabe Pharma Corporation for its lead product candidate, roluperidone, which is crucial for its operations[318]. - Future milestone payments from Royalty Pharma, totaling up to $95 million, depend on the successful development and commercialization of seltorexant by Janssen Pharmaceutica NV[319]. - The company may not successfully establish new collaborations, which could adversely affect its ability to develop and commercialize future product candidates[321]. - The patent prosecution process is expensive and time-consuming, and failure to secure patents could limit the company's competitive position[322]. - The uncertainty surrounding patent rights in the biotechnology sector poses risks to the company's ability to protect its technology and products[324]. - The expiration of patents related to proprietary products may lead to increased competition and reduced ability to recover development costs, with some patents expected to expire as early as 2028[325]. - The company has in-licensed or acquired intellectual property necessary for product development, and failure to comply with obligations could result in loss of these rights[328]. - Legal proceedings to protect intellectual property may be costly and time-consuming, with the risk of competitors infringing on patents[329]. - The company may need to license additional patents from third parties, and failure to obtain these licenses could materially harm the business[330]. - Changes in patent law could diminish the value of patents, impacting the company's ability to protect its product candidates[335]. - The company faces uncertainties regarding patent protection in foreign jurisdictions, which may allow competitors to develop similar products[338]. - Compliance with procedural requirements is crucial for maintaining patent rights, as non-compliance could lead to loss of patent protection[341]. - The company may be subject to claims regarding the wrongful use of trade secrets, which could result in costly litigation and loss of valuable rights[343]. - The confidentiality of trade secrets is critical, as breaches could harm the company's competitive position[344]. Stock and Capital Structure - The market price of the company's common stock may be volatile, affecting the ability to raise capital and enter strategic partnerships[346]. - As of December 31, 2023, executive officers, directors, and holders of 5% or more of the capital stock beneficially own approximately 49.2% of the voting stock, with 19.3% held by Federated Hermes, Inc. and 18.2% held by BI[348]. - The company anticipates significant additional capital will be needed in the future to fund planned operations, including completing clinical trials for product candidates[351]. - The management is authorized to grant stock options and other equity-based awards of up to 2,078,917 shares, which may lead to additional dilution for stockholders[352]. - The company incurs significant additional legal, accounting, and compliance costs as a public company, which may divert management's time and attention[353]. - The company is classified as a "smaller reporting company," allowing it to comply with reduced reporting requirements, potentially making its securities less attractive to investors[355]. - Future sales of common stock by existing stockholders could significantly impact the market price of the company's common stock[349]. - The company may issue additional equity or debt securities in the future, which could result in further dilution for existing stockholders[351]. - The concentration of stock ownership may delay or deter a change of control and affect the market price and liquidity of the common stock[348]. - The company faces risks related to market conditions, including economic downturns and regulatory changes, which may negatively affect stock prices[347]. - The management has broad discretion over the use of proceeds from public offerings and may not apply them in ways that enhance stockholder value[350].

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(D) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2023 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 No. 001-36517 Minerva Neurosciences, Inc. (Exact Name of Registrant as Specified in its Charter) Delaware 26-0784194 (State or Other Jurisdictio ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(D) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2023 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 No. 001-36517 Minerva Neurosciences, Inc. (Exact Name of Registrant as Specified in its Charter) Delaware 26-0784194 (State or Other Jurisdiction of ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(D) OF THE SECURITIES EXCHANGE ACT OF 1934 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(D) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2023 OR For the transition period from to . (I.R.S. Employer Identification No.) Commission File No. 001-36517 Registrant's telephone number, including area code: (617) 600-7373 (Former Name, Former Address a ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 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 001-36517 Minerva Neurosciences, Inc. (Exact name of Registrant as specified in its Charter) (State or other jurisdiction of incorporatio ...

Minerva Neurosciences, Inc. (NASDAQ:NERV) Q3 2022 Earnings Conference Call November 9, 2022 8:30 AM ET Company Participants Geoff Race - President Remy Luthringer - CEO Frederick Ahlholm - CFO Conference Call Participants Andrew Tsai - Jefferies Douglas Tsao - H.C. Wainwright Myles Minter - William Blair Operator Thank you for standing by. Welcome to the Minerva Neurosciences Third Quarter 2022 Conference Call. At this time, all participants are in a listen-only mode. After the speakers’ presentation, there ...

PART I [Financial Statements](index=4&type=section&id=Item%201.%20Financial%20Statements) Unaudited H1 2022 financial statements report a net loss of $18.5 million, a $8.4 million stockholders' deficit, and a 1-for-8 reverse stock split - On June 17, 2022, the company effected a **1-for-8 reverse stock split** of its common stock, with all share and per-share amounts retroactively adjusted[31](index=31&type=chunk)[32](index=32&type=chunk)[34](index=34&type=chunk) - In January 2021, the company sold its royalty interest in seltorexant for a **$60 million upfront payment**, with the liability growing to **$69.9 million** by June 30, 2022, due to accrued non-cash interest[46](index=46&type=chunk)[48](index=48&type=chunk) Condensed Consolidated Balance Sheets (Unaudited) | Metric | June 30, 2022 ($) | December 31, 2021 ($) | | :--- | :--- | :--- | | Cash and cash equivalents | $49,753,998 | $60,755,080 | | Total assets | $64,959,298 | $77,121,918 | | Liability related to the sale of future royalties | $69,932,614 | $66,327,321 | | Total liabilities | $73,341,542 | $69,146,275 | | Total stockholders' (deficit) equity | $(8,382,244) | $7,975,643 | Condensed Consolidated Statements of Operations (Unaudited) | Metric | Three Months Ended June 30, 2022 ($) | Three Months Ended June 30, 2021 ($) | Six Months Ended June 30, 2022 ($) | Six Months Ended June 30, 2021 ($) | | :--- | :--- | :--- | :--- | :--- | | Research and development | $4,131,978 | $5,520,928 | $9,091,841 | $8,779,635 | | General and administrative | $2,833,211 | $3,442,365 | $5,862,606 | $7,691,179 | | Net loss | $(8,717,714) | $(10,589,163) | $(18,482,143) | $(19,393,896) | | Net loss per share, basic and diluted | $(1.63) | $(1.98) | $(3.46) | $(3.63) | Condensed Consolidated Statements of Cash Flows (Unaudited) | Metric | Six Months Ended June 30, 2022 ($) | Six Months Ended June 30, 2021 ($) | | :--- | :--- | :--- | | Net cash used in operating activities | $(11,001,077) | $(11,142,185) | | Net cash provided by financing activities | $(5) | $60,000,000 | | Net (decrease) increase in cash | $(11,001,082) | $48,857,815 | [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=16&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses roluperidone NDA preparation, Q2 2022 operating expense decreases, and the sufficiency of $49.9 million cash for the next 12 months - The company is preparing for a potential **NDA submission for roluperidone in Q3 2022**, despite FDA concerns regarding Phase 2b study applicability and post hoc analyses for the Phase 3 study[73](index=73&type=chunk)[77](index=77&type=chunk)[79](index=79&type=chunk) - As of June 30, 2022, the company had approximately **$49.9 million** in cash, cash equivalents, and restricted cash, believed sufficient for **at least the next 12 months**[97](index=97&type=chunk) - Net cash used in operating activities for the six months ended June 30, 2022, was **$11.0 million**, primarily due to a net loss of **$18.5 million**, offset by non-cash expenses[105](index=105&type=chunk) Operating Expense Comparison (Q2 2022 vs Q2 2021) | Expense Category | Q2 2022 ($ millions) | Q2 2021 ($ millions) | Change ($ millions) | | :--- | :--- | :--- | :--- | | Research & Development | $4.1 million | $5.5 million | -$1.4 million | | General & Administrative | $2.8 million | $3.4 million | -$0.6 million | [Quantitative and Qualitative Disclosures about Market Risk](index=22&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20about%20Market%20Risk) The company reports this section is not applicable - Not applicable[115](index=115&type=chunk) [Controls and Procedures](index=22&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded disclosure controls and procedures were effective as of June 30, 2022, with no material changes to internal control over financial reporting - Based on an evaluation as of June 30, 2022, the Chief Executive Officer and Chief Financial Officer concluded that the company's disclosure controls and procedures were **effective**[117](index=117&type=chunk) - There were **no material changes** in internal control over financial reporting during the quarter[118](index=118&type=chunk) PART II — Other Information [Legal Proceedings](index=23&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently party to any legal proceedings expected to have a material adverse effect on its business - As of the report date, the company is **not party to any claim or litigation** that is expected to have a **material adverse effect** on its business[120](index=120&type=chunk) [Risk Factors](index=23&type=section&id=Item%201A.%20Risk%20Factors) Updated risk factors include significant accumulated losses, need for additional capital, potential Nasdaq delisting due to equity deficiency, and regained bid price compliance - The company has a history of **significant losses**, with an **accumulated deficit of $353.2 million** as of June 30, 2022, and expects to continue incurring losses[123](index=123&type=chunk)[124](index=124&type=chunk) - The company will require **additional capital** to finance operations, with existing cash of **$49.9 million** deemed sufficient for **at least the next 12 months**, though future financing is not guaranteed[126](index=126&type=chunk)[127](index=127&type=chunk) - On March 8, 2022, the company received a **deficiency letter from Nasdaq** for not meeting the **$10 million stockholders' equity requirement**, but was granted an **extension until September 5, 2022**, to regain compliance[156](index=156&type=chunk) - The company **regained compliance** with Nasdaq's **$1.00 minimum bid price requirement** on July 6, 2022, following a **1-for-8 reverse stock split** implemented in June 2022[155](index=155&type=chunk) - The company is subject to **evolving U.S. and foreign data privacy and security laws**, and non-compliance could lead to **significant penalties, litigation, and reputational harm**[136](index=136&type=chunk)[137](index=137&type=chunk)[138](index=138&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=29&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company reports no unregistered sales of equity securities during the period - None[159](index=159&type=chunk) [Defaults Upon Senior Securities](index=29&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) The company reports this section is not applicable - Not applicable[160](index=160&type=chunk) [Mine Safety Disclosures](index=29&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) The company reports this section is not applicable - Not applicable[161](index=161&type=chunk) [Other Information](index=29&type=section&id=Item%205.%20Other%20Information) The company reports this section is not applicable - Not applicable[162](index=162&type=chunk) [Exhibits](index=30&type=section&id=Item%206.%20Exhibits) This section lists exhibits filed with the report, including the Certificate of Amendment for the reverse stock split and Sarbanes-Oxley certifications - Lists exhibits filed with the report, including the **Certificate of Amendment** to the Amended and Restated Certificate of Incorporation effective June 17, 2022, and **Sarbanes-Oxley certifications**[164](index=164&type=chunk)

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ 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 No. 001-36517 Delaware 26-0784194 (State or Other Jurisdiction of Incorporation or Organization) Indicate by check mark whether the registrant has sub ...