As filed with the Securities and Exchange Commission on April 21, 2023 Registration No. 333-269442 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 AMENDMENT NO. 4 TO FORM S-1 REGISTRATION STATEMENT Under The Securities Act of 1933 ZYVERSA THERAPEUTICS, INC. (Exact name of Registrant as specified in its charter) (State or other jurisdiction of incorporation or organization) (Primary Standard Industrial Classification Code Number) Delaware 2834 86-2685744 (I.R.S. Employer Identificatio ...

As filed with the Securities and Exchange Commission on April 17, 2023 Registration No. 333-269442 UNITED STATES SECURITIES AND EXCHANGE COMMISSION REGISTRATION STATEMENT Under The Securities Act of 1933 ZYVERSA THERAPEUTICS, INC. (Exact name of Registrant as specified in its charter) (State or other jurisdiction of incorporation or organization) Washington, D.C. 20549 AMENDMENT NO. 3 TO FORM S-1 (Primary Standard Industrial Classification Code Number) Delaware 2834 86-2685744 (I.R.S. Employer Identificatio ...

As filed with the Securities and Exchange Commission on April 11, 2023 Registration No. 333-268934 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 AMENDMENT NO. 2 TO FORM S-1 REGISTRATION STATEMENT Under The Securities Act of 1933 ZYVERSA THERAPEUTICS, INC. (Exact name of Registrant as specified in its charter) (State or other jurisdiction of incorporation or organization) (Primary Standard Industrial Classification Code Number) Delaware 2834 86-2685744 (I.R.S. Employer Identificatio ...

As filed with the Securities and Exchange Commission on April 4, 2023 Registration No. 333-269442 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 AMENDMENT NO. 2 TO FORM S-1 REGISTRATION STATEMENT Under The Securities Act of 1933 ZYVERSA THERAPEUTICS, INC. (Exact name of Registrant as specified in its charter) (State or other jurisdiction of incorporation or organization) (Primary Standard Industrial Classification Code Number) Delaware 2834 86-2685744 (I.R.S. Employer Identification ...

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]

As filed with the Securities and Exchange Commission on February 13, 2023 Registration No. 333-269442 ZYVERSA THERAPEUTICS, INC. (Exact name of Registrant as specified in its charter) UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 AMENDMENT NO. 1 TO FORM S-1 REGISTRATION STATEMENT Under The Securities Act of 1933 (State or other jurisdiction of incorporation or organization) (Primary Standard Industrial Classification Code Number) Delaware 2834 86-2685744 (I.R.S. Employer Identifica ...

As filed with the Securities and Exchange Commission on February 1, 2023 Registration No. 333-268934 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 AMENDMENT NO. 1 TO FORM S-1 REGISTRATION STATEMENT Under The Securities Act of 1933 ZYVERSA THERAPEUTICS, INC. (Exact name of Registrant as specified in its charter) Delaware 2834 86-2685744 (State or other jurisdiction of incorporation or organization) (Primary Standard Industrial Classification Code Number) (I.R.S. Employer Identificat ...

As filed with the Securities and Exchange Commission on January 27, 2023 Registration No. 333- UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM S-1 REGISTRATION STATEMENT Under The Securities Act of 1933 ZYVERSA THERAPEUTICS, INC. (Exact name of Registrant as specified in its charter) (State or other jurisdiction of incorporation or organization) Delaware 2834 86-2685744 (Primary Standard Industrial Classification Code Number) (I.R.S. Employer Identification Number) 2200 N. Comme ...

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].