"Elevations in plasma ASC in early cognitive decline reinforce the role of inflammasome-induced inflammation in the development of neurodegenerative conditions such as Alzheimer's and Parkinson's diseases," stated Stephen C. Glover, ZyVersa's Co-founder, Chairman, CEO, and President. "ZyVersa is developing Inflammasome ASC Inhibitor IC 100 to inhibit multiple types of inflammasomes and their associated ASC specks that trigger damaging inflammation pathogenic in neurological and other inflammatory diseases, ...

ZyVersa is advancing a dynamic pipeline of drug candidates with multiple programs built around two proprietary technologies – Phase 2a Cholesterol Efflux Mediator™ VAR 200 for treatment of kidney diseases, and Inflammasome ASC Inhibitor IC 100 for treatment of obesity and its associated metabolic complications, among other inflammatory diseases. Mr. Glover welcomes one-on-one meetings with registered participants. Details regarding Mr. Glover's Presentation follow: About ZyVersa Therapeutics, Inc. WESTON, F ...

Financial Performance - ZyVersa Therapeutics reported a net loss of $2,826,737 for Q1 2024, a decrease of 20.2% compared to a net loss of $3,543,950 in Q1 2023[76] - Total operating expenses for Q1 2024 were $2,827,000, down 38.4% from $4,592,000 in Q1 2023[88] - Research and development expenses decreased by 51.4% to $513,000 in Q1 2024 from $1,056,000 in Q1 2023, primarily due to lower manufacturing costs and payroll[89] - General and administrative expenses were $2,314,000 in Q1 2024, a decrease of 34.6% from $3,536,000 in Q1 2023, attributed to reduced payments and accruals[90] - Net cash used in operating activities was $3.8 million for Q1 2024, compared to $4.6 million for Q1 2023, reflecting a decrease of $812,000[92] - Net cash provided by financing activities was $2.7 million in Q1 2024, a significant increase from a net cash used of $35,000 in Q1 2023[93] Financial Position - As of March 31, 2024, ZyVersa had an accumulated deficit of approximately $106.0 million and cash of $2.0 million[76] - Current assets as of March 31, 2024, were $2,900,000, while current liabilities were $9,583,000, resulting in a working capital deficiency of $6,683,000[94] - As of March 31, 2024, the company has approximately $9.6 million in current liabilities for accounts payable and accrued expenses[96] Future Outlook - The company has not generated any revenue since inception and anticipates continued operating losses until significant revenue can be generated from product candidates[78] - ZyVersa expects to require additional financing to support ongoing operations and development activities, with no assurance that such financing will be available on acceptable terms[77] - The company expects to incur substantial additional operating losses for at least the next several years as it continues to develop product candidates and seek marketing approval[100] - Future capital needs will depend on various factors, including the initiation and progress of clinical trials for product candidates[101] Strategic Plans - The company plans to commit substantial resources to research and development, clinical trials, and potential product acquisitions to grow its business over the long term[102] - The company intends to raise additional capital through equity, equity-linked securities, or debt in subsequent offerings[98] - If the company raises additional funds through collaboration and licensing arrangements, it may need to relinquish valuable rights to its technologies or future revenue streams[103] - The company has no current arrangements for acquisitions or in-licensing but continues to evaluate strategic relationships with established pharmaceutical companies[102] Compliance and Governance - The company expects to incur significant costs related to compliance with corporate governance and internal controls as a public company[100] - There are no off-balance sheet arrangements that materially affect the company's financial conditions or results[107] Investment Strategy - The company’s cash equivalents will primarily be invested in money market funds to preserve principal balance and provide liquidity[99]

Drug Development Focus - The company is focused on developing drugs for chronic renal and inflammatory diseases, addressing high unmet medical needs[18] - The company aims to expand its product portfolio through indication expansion for VAR 200 and IC 100, as well as potential in-licensing opportunities[27] - The company is focused on developing drugs for chronic renal and inflammatory diseases, with a mission to improve health outcomes and quality of life for patients[18] Lead Indications and Trials - The lead indication for VAR 200 is focal segmental glomerulosclerosis (FSGS), with approximately 40,000 patients affected in the U.S.[24] - VAR 200 has received FDA approval to proceed to a Phase 2a trial for FSGS, with a small open-label Phase 2a trial for diabetic kidney disease planned for H1-2024[20] - The company anticipates submitting an IND for IC 100 in Q4-2024, targeting multiple sclerosis and acute respiratory distress syndrome[21] - The company plans to select lead indications for IC 100 based on preclinical data prior to the IND filing[29] Market Opportunity and Unmet Needs - Chronic kidney disease (CKD) affects over 75 million people globally, with significant economic burdens, including $130 billion in Medicare spending in 2018[22] - The economic burden of CKD and the lack of disease-modifying therapies create a significant market opportunity for the company's products[22] - Current drugs for FSGS and other renal diseases do not effectively delay or halt disease progression, creating a significant unmet need in the market[31] - The company believes there is a significant unmet need for effective FSGS-specific treatments to improve patients' quality of life and reduce health economic burden[87] - There are currently no commercially available disease-specific treatments for AS, highlighting a significant unmet need for effective therapies[90] Product Development and Efficacy - VAR 200 is an injectable drug in clinical development targeting chronic glomerular diseases, with a Phase 2a trial in diabetic kidney disease expected to start in H1-2024[36] - VAR 200 demonstrated significant reduction in proteinuria in FSGS mouse models, indicating its potential to delay kidney disease progression[46] - VAR 200 significantly reduced renal damage and proteinuria in Alport Syndrome models, suggesting its protective effects on kidney function[53] - IC 100 targets the ASC component of inflammasomes, which are linked to various chronic inflammatory diseases, presenting a competitive advantage[26] - IC 100 has shown pharmacologic proof-of-concept data in animal models for ARDS and MS, with ongoing studies for Parkinson's disease, atherosclerosis, and obesity[60] Regulatory and Compliance - The FDA regulates drug products and requires extensive data demonstrating quality, safety, and efficacy before approval[126][127] - The FDA requires a user fee payment exceeding $2.5 million for each NDA or BLA submission, unless a waiver applies[142] - The FDA aims to review standard NDAs or BLAs within 12 months and prior review biologics within 8 months from submission[146] - The FDA may issue a complete response letter if the application is not ready for approval, which may require additional clinical data or trials[147] - The company is subject to extensive regulations from multiple authorities, including the FDA and CMS, which could impact its operational flexibility[177] Financial and Operational Aspects - Research and development expenses totaled approximately $5.4 million for the Predecessor period and $3.2 million for the year ended December 31, 2023[116] - The company currently relies on third-party suppliers for the manufacturing, testing, and distribution of its product candidates VAR 200 and IC 100[114] - The company is facing increasing pressure on product pricing due to regulatory changes and managed healthcare practices in the United States, which may lead to lower average selling prices[174] - The company must comply with various healthcare laws, including the False Claims Act and the Anti-Kickback Statute, which could impact sales and marketing activities[176] Employee and Operational Structure - As of December 31, 2023, the company had seven full-time employees, indicating a lean operational structure[185] - The company has a good relationship with its employees, which is crucial for maintaining operational efficiency[185] Strategic Partnerships and Agreements - The company has entered into a License Agreement with L&F Research, involving an upfront fee of $200,000 and potential milestone payments up to $21.5 million[104] - The InflamaCORE License Agreement includes an upfront fee of $346,321.08 and potential milestone payments up to $22.5 million, with royalties ranging from 5% to 10% on net sales[111] Competitive Landscape - The pharmaceutical and biotechnology industry is highly competitive, with many competitors having greater financial and technical resources[118] - VAR 200 is believed to be the only drug in development addressing lipid accumulation in the glomerulus, while IC 100 may be the only monoclonal antibody targeting the ASC component of the inflammasome[120][121]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2023 ☐ 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: 001-41184 ZYVERSA THERAPEUTICS, INC. (Exact name of registrant as specified in its charter) Delaware 86-268 ...

Financial Performance - For the six months ended June 30, 2023, the net loss was $82.1 million, compared to a net loss of $5.8 million for the same period in 2022, reflecting a significant increase in operating losses [97]. - The company recorded a pre-tax net loss of $86.3 million for the three months ended June 30, 2023, compared to a pre-tax net loss of $2.0 million for the same period in 2022, indicating a substantial increase in losses [112]. - The company incurred a net loss of $82.1 million for the six months ended June 30, 2023, compared to a net loss of $5.8 million for the same period in 2022, resulting in an accumulated deficit of $87.0 million [128]. Expenses - Research and development expenses for the three months ended June 30, 2023, were $1.2 million, an increase of 69.7% from $0.7 million in the same period in 2022, primarily due to increased manufacturing costs for IC 100 [113]. - General and administrative expenses for the three months ended June 30, 2023, were $3.9 million, a 237.5% increase from $1.2 million in the same period in 2022, driven by stock grants and increased professional fees [114]. - Total operating expenses for the three months ended June 30, 2023, were $86.3 million, a dramatic increase of 4338.6% compared to $1.9 million in the same period in 2022 [112]. - Research and development expenses increased to $2.3 million for the six months ended June 30, 2023, up $0.5 million or 27.4% from the same period in 2022 [119]. - General and administrative expenses rose to $7.5 million, an increase of $4.0 million or 115.4% compared to the prior year, primarily due to stock grants and professional fees [120]. - Impairment of in-process research and development was $69.3 million for the three months ended June 30, 2023, compared to none in the same period in 2022, due to a decline in stock value [115]. - Impairment of in-process research and development and goodwill totaled $69.3 million and $11.9 million, respectively, compared to none in the prior year, reflecting a decline in stock value [121]. Cash Flow and Financing - Net cash used in operating activities was $5.0 million for the six months ended June 30, 2023, compared to $0.7 million in the same period of 2022, driven by a net loss of approximately $82.1 million [124]. - Cash provided by financing activities was negative $0.7 million for the six months ended June 30, 2023, primarily due to the redemption of Series A Preferred Stock [125]. - The company will seek additional financing through public or private equity or debt financings to support its operations, as adequate financing may not be available on acceptable terms [98]. - The company plans to raise additional capital to fund operations and the development of product candidates VAR200 and IC100 [131]. - Future operations depend on successful capital raising efforts, as the current cash balance is only sufficient for month-to-month operational expenses [128]. Current Assets and Liabilities - Current assets decreased to $1.1 million as of June 30, 2023, from $6.4 million at the end of 2022, while current liabilities increased to $10.5 million [127]. - The company had an accumulated deficit of approximately $87.0 million as of June 30, 2023, with cash reserves of only $0.2 million [97]. - The company has significant contractual obligations totaling approximately $10.5 million for accounts payable and accrued expenses as of June 30, 2023 [129]. Future Outlook - The company has not generated any revenue to date and does not expect to do so in the near future, relying on future collaborations or regulatory approvals for potential revenue [99]. - The company anticipates continued significant expenses related to ongoing research and development activities, which are expected to increase as clinical trials progress [103].

Financial Performance - ZyVersa Therapeutics reported a net loss of $3,543,950 for the three months ended March 31, 2023, compared to a net loss of $3,748,495 for the same period in 2022, reflecting a decrease of 5.5%[77][90] - The company incurred a net loss of $3.5 million for the three months ended March 31, 2023, compared to a net loss of $3.7 million for the same period in 2022, with an accumulated deficit of $8.5 million as of March 31, 2023[100] - Total other income (expense), net was $1,000 for the three months ended March 31, 2023, a significant improvement from a net expense of $380,000 in the same period of 2022[94] Operating Expenses - Total operating expenses for the Successor Period were $4,592,000, an increase of 36.3% from $3,368,000 in the Predecessor Period[90] - General and administrative expenses increased to $3,536,000 for the three months ended March 31, 2023, up by 53.7% from $2,301,000 in the prior year, primarily due to higher costs in insurance and marketing[92] - Research and development expenses remained consistent at approximately $1,056,000 for the three months ended March 31, 2023, with a slight decrease of 1.0% from $1,067,000 in the same period of 2022[91] Cash Flow and Liquidity - Net cash used in operating activities was $4,589,000 for the three months ended March 31, 2023, compared to $374,000 for the same period in 2022[96] - The company had an accumulated deficit of approximately $8.5 million as of March 31, 2023, with cash reserves of $1.3 million[77] - As of March 31, 2023, current assets were $2.835 million, down from $6.363 million in 2022, while current liabilities increased to $8.578 million from $8.188 million, resulting in a working capital deficiency of $5.743 million compared to $1.825 million in 2022[98] - Cash requirements for current liabilities as of March 31, 2023, include approximately $8.6 million for accounts payable and accrued expenses[101] Future Financing and Development Plans - The company has not generated any revenue to date and does not expect to do so in the near future, relying on future financing to support operations[79][78] - The company expects to seek additional financing through public or private equity or debt financings to support ongoing operations[78] - The company plans to raise additional capital through equity or equity-linked securities to fund continued development of its product candidates[104] - The company plans to continue increasing research and development expenses as it advances its product candidates VAR 200 and IC 100[81] - Future operating cash and capital requirements will depend on various factors, including clinical trial costs and regulatory requirements[107] - The company intends to commit substantial resources to research and development, clinical trials, and potential product acquisitions to grow its business over the long term[108] Regulatory and Compliance - The company is classified as an "emerging growth company" under the JOBS Act, allowing it to delay compliance with new accounting standards[110] - There are no off-balance sheet arrangements that could materially affect the company's financial conditions or results of operations[113] - The company anticipates needing additional financing to fund operations and product development, with no assurance that such financing will be available on favorable terms[100]

Drug Development Focus - The company is focused on developing drugs for chronic renal and inflammatory diseases, leveraging proprietary technologies[17] - The company aims to expand its product portfolio through indication expansion for VAR 200 and IC 100, as well as potential in-licensing opportunities[26] - The company plans to capitalize on indication expansion strategies, targeting multiple indications for both VAR 200 and IC 100 platforms, including FSGS, Alport Syndrome, and diabetic kidney disease[32] - The company intends to maintain rights for developing and commercializing its product candidates in the U.S. while pursuing strategic alliances for international markets[32] - The company plans to expand its product portfolio by identifying and in-licensing additional drug candidates with significant clinical and commercial potential[32] VAR 200 Development - The lead indication for VAR 200 is focal segmental glomerulosclerosis (FSGS), with approximately 40,000 patients affected in the U.S.[19][23] - VAR 200 has received FDA approval to proceed to a Phase 2a trial for FSGS, with an open-label investigator-initiated trial planned for Q4-2023[19] - VAR 200 is in development for chronic glomerular diseases, initially focusing on Focal Segmental Glomerulosclerosis (FSGS), with plans for an open-label IIT in Q4-2023 and a Phase 2a trial to follow[34] - VAR 200 has shown significant reductions in proteinuria in animal models, indicating potential to delay or prevent progression of kidney disease[39] - VAR 200 is believed to be the only drug in development targeting lipid accumulation in the glomerulus, which could be used in combination with other therapies for renal disease[111] - The intellectual property for VAR 200 includes issued and pending patents covering glomerular disorders and diabetic kidney disease, with plans to seek orphan drug designation for FSGS and Alport Syndrome[32] - VAR 200 is an injectable drug targeting chronic glomerular diseases, initially focusing on FSGS, with potential expansion to Alport Syndrome and diabetic kidney disease[33] - The mechanism of action for VAR 200 involves mediating cholesterol efflux through interaction with the glomerular membrane, aiming to preserve renal structure and function[36] IC 100 Development - The inflammasome ASC inhibitor program, IC 100, is in preclinical development, with an IND submission planned for Q2-2024 and potential lead indications to be selected based on preclinical data[20] - IC 100 targets inflammasome ASC, which is linked to various chronic inflammatory diseases, presenting a broad market opportunity[25][28] - IC 100 is a monoclonal antibody in preclinical development targeting chronic inflammation in various diseases[55] - IC 100 has shown pharmacologic proof-of-concept in animal models for ARDS and MS, with plans for additional studies in up to 6 indications[56] - IC 100 demonstrated a reduction in inflammasome-mediated cytokine IL-1β in AD mice at 1-week post-injury, indicating its potential in neuroinflammatory conditions[60] - IC 100 has shown potential to mediate persistent damaging inflammation associated with various inflammatory diseases[68] - The IC 100 preclinical program is set for a planned IND submission in Q2-2024, with non-GLP toxicology data showing no adverse effects at doses up to 300mg/kg[32] Market Opportunity - Chronic kidney disease (CKD) affects over 75 million people globally, with significant economic burdens, including $130 billion in Medicare spending in 2018[21] - Approximately 40-60% of FSGS patients may progress to end-stage kidney disease within 10-20 years, necessitating dialysis or transplant[23] - The total addressable market for FSGS is estimated to affect around 40,000 people in the U.S., with over 5,400 new cases diagnosed annually[76] - Diabetic nephropathy is responsible for 30 to 40% of all end-stage renal disease cases in the U.S., highlighting a significant market opportunity[83] - The global anti-inflammatory biologics market was valued at $64.84 billion in 2019 and is projected to reach $149.80 billion by 2027[87] - In 2019, U.S. disease-modifying drugs for Multiple Sclerosis (MS) achieved $14.4 billion in sales[91] - The U.S. prevalence of Diabetic Kidney Disease is up to 12 million, with current drugs failing to effectively delay disease progression[30] - The U.S. prevalence of Multiple Sclerosis is approximately 1 million, with current treatments not effectively halting disease progression[30] Financial and Operational Aspects - The company spent approximately $6.5 million on research and development activities in 2020[108] - The company spent $2.2 million during the year ended December 31, 2021, and $5.4 million for the predecessor period from January 1, 2022, through December 12, 2022[108] - The company has no current manufacturing capabilities and relies on third-party suppliers for the production of its product candidates[105] - The company currently lacks marketing, sales, or distribution capabilities and plans to build its commercial infrastructure over time, potentially relying on strategic partnerships for product commercialization[109] - The company paid an upfront license fee of $200,000 to L&F Research for the development and commercialization of VAR 200[98] - The company agreed to make additional payments to L&F Research upon achieving certain development milestones, up to an aggregate maximum of $21.5 million[98] Regulatory Environment - Regulatory approval processes for new drugs in the U.S. require substantial time and financial resources, with compliance being critical to avoid sanctions[122] - The company must conduct extensive clinical trials, including Phase 1, Phase 2, and Phase 3, to demonstrate the safety and efficacy of its drug candidates before seeking FDA approval[129] - All clinical trials must adhere to FDA regulations, including good clinical practice requirements, to ensure participant safety and data integrity[130] - The cost of preparing and submitting a New Drug Application (NDA) or Biologics License Application (BLA) exceeds $2.5 million as of fiscal year 2019[134] - The FDA aims to review standard NDAs or BLAs within 12 months and priority review biologics within 8 months from submission[138] - The FDA may issue a complete response letter if the NDA or BLA is not ready for approval, which may require additional clinical data or trials[139] - The FDA can restore up to five years of patent life for a new product under the Hatch-Waxman Act, but cannot extend the total patent term beyond 14 years from the date of product approval[147] - The FDA requires that each component of a combination drug product contributes to the claimed effects, necessitating larger studies[132] - Sponsors must disclose clinical trial information, including results, which can be used by competitors to assess development progress[133] - The FDA conducts inspections of manufacturing facilities before approving an NDA or BLA to ensure compliance with current good manufacturing practices (cGMP)[140] - Post-approval testing and surveillance may be required by the FDA to monitor a product's safety or efficacy after approval[142] - Changes to approved applications may require submission and FDA approval of a new NDA or BLA supplement[144] - The FDA provides a five-year period of non-patent marketing exclusivity for the first applicant to gain approval of a New Drug Application (NDA) for a new chemical entity (NCE) in the U.S.[149] - Under the Biologics Price Competition and Innovation Act (BPCIA), a reference biologic is granted twelve years of exclusivity from the time of first licensure[151] - Fast track designation allows for greater interactions with the FDA and may expedite the review process for drugs intended to treat serious conditions[152] - Breakthrough Therapy designation requires the FDA to expedite the development and review of drugs that show substantial improvement over existing therapies[154] - Accelerated approval may be granted based on a surrogate endpoint that predicts clinical benefit, contingent on post-approval confirmatory studies[155] - Orphan drug designation provides a seven-year exclusive marketing period for drugs treating rare diseases affecting fewer than 200,000 individuals in the U.S.[158] - The Pediatric Research Equity Act mandates that NDAs must contain data assessing safety and effectiveness in pediatric populations[159] - The Best Pharmaceuticals for Children Act allows for a six-month extension of exclusivity for drugs if pediatric studies are conducted as requested by the FDA[160] - Compliance with FDA regulations is critical, as failure to do so may result in enforcement actions that could adversely affect the company's financial condition and operations[162] Company Structure and Legal Matters - The company has seven full-time employees as of December 31, 2022, engaged in various operational functions[180] - The company is not currently involved in any material legal proceedings, but potential litigation could impact its business operations[181]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 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: 001-41184 LARKSPUR HEALTH ACQUISITION CORP. (Exact name of registrant as specified in its charter) Delawa ...

Financial Performance - The company reported a net loss of $393,639 for the three-month period ended June 30, 2022, primarily due to formation and operating costs of $498,751, partially offset by interest income of $105,113 [111]. - For the six-month period ended June 30, 2022, the net loss was $1,113,645, consisting of formation and operating costs of $1,299,800, offset by interest income of $109,567 and a change in fair value of derivative liability of $76,588 [111]. - Cash used in operating activities for the six months ended June 30, 2022, was $588,350, primarily due to the net loss [123]. - The diluted net loss per common share is the same as the basic net loss per common share due to the absence of dilutive securities as of June 30, 2022 [131]. Capital Raising and Liquidity - The company completed its IPO on December 23, 2021, raising gross proceeds of $75,000,000 from the sale of 7,500,000 units at $10.00 per unit [112]. - An additional $2,698,306 was raised from the exercise of the underwriters' over-allotment option, bringing total gross proceeds to $77,698,306 [114]. - The company has approximately $1,250,000 available outside the trust account for identifying and evaluating target businesses and conducting due diligence [116]. - Estimated primary liquidity requirements include $425,000 for legal and accounting expenses, $600,000 for D&O insurance, and $150,000 for regulatory reporting fees [118]. - The company intends to use substantially all funds in the trust account to complete its initial business combination [115]. Debt and Going Concern - The company does not have any long-term debt obligations or capital lease obligations [124]. - There is substantial doubt about the company's ability to continue as a going concern within one year after the issuance of the financial statements [122]. Stockholder Rights and Securities - The company has agreed to waive redemption rights for founder shares in connection with business combinations and stockholder votes, with a potential extension of up to 18 months from the IPO closing [127]. - The company is required to register certain securities for sale under the Securities Act, allowing initial stockholders to make up to three demands for registration [128]. - As of June 30, 2022, the company reported Class A common stock subject to possible redemption amounting to $78,448,306, classified as temporary equity [133]. Accounting and Market Risk - The company has no identified critical accounting policies or estimates that could materially differ from actual results [129]. - The company evaluates its financial instruments to determine if they qualify as derivatives, with changes in fair value reported in the statements of operations [132]. - The company has not disclosed any market risk information as it qualifies as a smaller reporting company [134].