As filed with the Securities and Exchange Commission on December 8, 2025. Registration No. 333- UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 GRI BIO, INC. (Exact name of registrant as specified in its charter) (Primary Standard Industrial Classification Code Number) Delaware 2834 82-4369909 (I.R.S. Employer Identification Number) (State or other jurisdiction of incorporation or organization) 2223 Avenida de la Playa, ...

Core Insights - Enlivex Therapeutics Ltd. will host a virtual fireside chat on December 11, 2025, to discuss its recent $212 million private placement and future plans [1][2][3] - The company is focusing on advancing the clinical development of Allocetra™, a therapy for osteoarthritis, which affects over 32.5 million Americans and 300 million people globally [5] Company Plans - Shai Novik, Executive Chairman, will provide updates on the digital asset treasury strategy centered around RAIN token accumulation [2] - Enlivex aims to offer investors exposure to RAIN as a primary treasury reserve asset [4] Clinical Development - Allocetra™ is designed to treat osteoarthritis, a prevalent joint disease with significant hospitalization rates in the U.S. [5] - There are currently no FDA or EMA approved medications that can halt or reverse joint damage in osteoarthritis patients [5]

Core Insights - The company has transitioned from being primarily a diabetes-focused entity to diversifying its portfolio, particularly in the area of rare diseases and orphan lung conditions [1] - The partnership with UT has been fruitful and continues to develop positively, indicating a strong collaborative effort in research and development [1] - The company aims to create more catalysts for growth and positive developments to attract momentum and catalyst-driven investors [1]

Core Insights - Nxera Pharma reported strong progress in the first half of 2025, with increasing revenues from its marketed products PIVLAZ® and QUVIVIQ®, and advancements in partnered programs [2][3][6] Operational Highlights - PIVLAZ® revenue increased by 7.6% from JPY 5,393 million to JPY 5,805 million compared to the prior corresponding period [6] - QUVIVIQ® generated JPY 1,586 million in revenue for the first half of 2025, with no sales in the prior corresponding period due to its launch in Q4 2024 [6] - Neurocrine Biosciences initiated Phase 3 trials for NBI-'568, resulting in a US$15 million payment to Nxera [6] - Nxera achieved a US$4.8 million milestone payment from Centessa Pharmaceuticals for the initiation of clinical development of ORX142 [6] Financial Highlights - Total revenue for the first half of 2025 was JPY 15,094 million (US$101.6 million), an increase of JPY 2,374 million (US$18.0 million) compared to the prior corresponding period [11] - R&D expenses rose to JPY 7,474 million (US$50.3 million), reflecting increased investment in R&D and currency impact [11] - SG&A expenses decreased to JPY 7,566 million (US$51.0 million), primarily due to targeted cost savings [11] - Operating loss improved to JPY 2,756 million (US$18.5 million) from JPY 3,654 million (US$24.0 million) in the prior corresponding period [11] - Net loss decreased to JPY 3,137 million (US$21.1 million) from JPY 4,703 million (US$30.9 million) in the prior corresponding period [11] - Cash and cash equivalents as of 30 June 2025 were JPY 32,997 million (US$228.1 million), an increase of JPY 729 million (US$22.3 million) from the beginning of the year [11] Pipeline and Future Outlook - Nxera is advancing a proprietary pipeline targeting obesity and chronic weight management, with over 30 active programs [5][10] - The company is well-positioned for significant value delivery for patients and shareholders with multiple key data readouts and new studies expected in the second half of 2025 [3][10]

Core Insights - Vanda Pharmaceuticals reported a significant increase in Fanapt revenue, driven by expanded sales efforts and a direct-to-consumer brand awareness campaign, with expectations for continued growth in upcoming quarters [2][6] - The company anticipates important regulatory and clinical milestones that could enhance its commercial portfolio and advance its clinical pipeline [2] Financial Highlights - In Q2 2025, net product sales from Fanapt® reached $29.3 million, a 27% increase from $23.2 million in Q2 2024 [6][7] - Total net product sales from Fanapt®, HETLIOZ®, and PONVORY® were $52.6 million in Q2 2025, a 4% increase compared to $50.5 million in Q2 2024 [7] - The net loss for Q2 2025 was $27.2 million, compared to a net loss of $4.5 million in Q2 2024 [9] - Cash and cash equivalents stood at $325.6 million as of June 30, 2025, reflecting a decrease of $15.4 million from March 31, 2025 [7] Operational Highlights - Bysanti™ NDA for bipolar I disorder and schizophrenia is under FDA review with a PDUFA target action date of February 21, 2026 [6][8] - Tradipitant NDA for motion sickness is also under review, with a PDUFA target action date of December 30, 2025 [6][14] - Fanapt® experienced a 24% increase in total prescriptions (TRx) in Q2 2025 compared to Q2 2024 [7] Financial Guidance - Vanda expects total revenues for the full year 2025 to be between $210 million and $250 million, with year-end cash projected to be between $280 million and $320 million [11]

Business Performance & Growth - VOQUEZNA achieved over 300,000 filled prescriptions launch-to-date[13, 24] - Commercial coverage exceeds 80%, covering over 120 million commercial lives[9, 41] - Primary Care Physicians (PCPs) are increasingly contributing to prescription growth, with a ~2x increase in PCP awareness[39] - Approximately 70% of prescriptions in Q4 were refills, indicating continued therapy[31] - HCPs reporting patient requests increased by over 55% since the Direct-to-Consumer (DTC) campaign launch[43] Financial Results - Q4 2024 net revenue reached $29.7 million, reflecting an ~81% increase from the previous quarter[50] - The company reported a GAAP net loss of ($74.451) million for Q4 2024 and ($334.326) million for the full year 2024[54] - Non-GAAP adjusted net loss was ($56.376) million for Q4 2024 and ($262.316) million for the full year 2024[54] - Cash and cash equivalents totaled $297.3 million as of December 31, 2024[55] Legal & Development - The FDA acknowledged the Citizen Petition on 12/11/24, related to VOQUEZNA Orange Book listings[16] - The company is developing a strategy for OTC acid control market, which generates ~$3 billion annually[15]

Core Insights - Inventiva, a clinical-stage biopharmaceutical company, has appointed Renée Aguiar-Lucander to its Board of Directors, a decision approved by shareholders at the recent Annual General Meeting [1][2] - The company is focused on developing oral therapies for metabolic dysfunction-associated steatohepatitis (MASH) and is currently in the final stages of clinical development for its drug lanifibranor [1][3] Company Overview - Inventiva specializes in the research and development of oral small molecule therapies aimed at treating MASH and other diseases with significant unmet medical needs [3] - The company is evaluating lanifibranor, a novel pan-PPAR agonist, in the NATiV3 pivotal Phase 3 clinical trial for adult patients with MASH, a progressive chronic liver disease [3] Leadership Background - Renée Aguiar-Lucander, the newly appointed board member, has a strong background in the biopharmaceutical industry, having served as CEO of Hansa Biopharma and Calliditas Therapeutics, where she led the latter to a $1.1 billion acquisition by Asahi Kasei in 2024 [2] - Under her leadership, Calliditas achieved the first-ever FDA approval for a treatment in IgA nephropathy and successfully launched the product in the U.S. [2] Strategic Importance - The appointment of Aguiar-Lucander is seen as pivotal for Inventiva as it prepares for the potential approval and launch of lanifibranor [2] - The NATiV3 Phase 3 trial is fully enrolled, indicating progress towards bringing lanifibranor to patients with MASH [2]

Core Insights - Windtree Therapeutics is focused on becoming a revenue-generating company by acquiring FDA-approved assets and advancing its cardiology and oncology pipeline [2] - The company reported a first-quarter operating loss of $4.1 million, an improvement from a loss of $4.4 million in the same period last year [4] - Windtree has entered into a strategic transaction to acquire a multifamily residential property, which is expected to generate revenue while the company develops its biotech pipeline [6] Financial Performance - For Q1 2025, research and development expenses remained stable at $2.3 million compared to Q1 2024 [5] - General and administrative expenses decreased to $1.8 million from $2.1 million in the previous year, primarily due to reduced professional fees [7] - The net loss attributable to common stockholders was $5.0 million ($4.63 per share) for Q1 2025, compared to a net income of $10.2 million ($1,099.37 per share) in Q1 2024 [8] Business Developments - The company is advancing its istaroxime program for cardiogenic shock, with ongoing enrollment in a clinical study and plans for an interim analysis in Q3 2025 [2] - Windtree has established a partnership with a biopharmaceutical company in China to reduce production costs by nearly 65%, with anticipated revenue generation by the end of 2026 [2] - The company has expanded its patent estate for istaroxime and received a notice of allowance in acute heart failure from the U.S. Patent and Trademark Office [6] Cash Position - As of March 31, 2025, Windtree reported cash and cash equivalents of $1.2 million and current liabilities of $6.5 million, indicating sufficient resources to fund operations through May 2025 [9]

Financial Data and Key Metrics Changes - CorMedix reported first quarter net sales of $39.1 million, achieving profitability with a net income of $20.6 million or $0.32 per share, compared to a net loss of $14.5 million or $0.25 per share in the same quarter of the previous year [14][15]. - Adjusted EBITDA for the first quarter was $23.6 million, slightly above earlier preannounced results [6]. Business Line Data and Key Metrics Changes - The company experienced steady utilization growth with existing anchor customer U.S. Renal Care and new utilization from smaller outpatient dialysis operators and inpatient hospitals [6]. - Inpatient hospital ordering accounted for more than 6% of shipments in April, more than double from the first quarter [7]. Market Data and Key Metrics Changes - U.S. Renal Care accounted for over 80% of shipments in the first quarter, indicating its significance as the largest customer [30][31]. - The company anticipates utilization growth in the latter half of 2025 as new patients initiate therapy and new customers are added [9]. Company Strategy and Development Direction - CorMedix is focused on expanding its customer base and therapeutic indications for DEFENCATH, with a dedicated inpatient sales team now fully operational [10][13]. - The company has initiated a Phase 3 clinical study targeting central line-associated bloodstream infections, aiming for FDA submission by late 2026 or early 2027 [10][11]. Management's Comments on Operating Environment and Future Outlook - Management expressed optimism regarding the implementation timeline with a large dialysis operator customer, expecting to start mid-2025 [9]. - The company is monitoring macroeconomic factors but does not foresee them impacting inventory or earnings significantly [25]. Other Important Information - Operating expenses increased by approximately 9% to $17.4 million, with R&D expenses rising by 281% due to increased personnel and clinical trial services [15][16]. - The company has cash and cash equivalents of $77.5 million as of March 31, 2025 [16]. Q&A Session Summary Question: Updates on LDO partnership and operational expectations - Management noted heightened preparatory activities with the LDO but did not provide specific patient numbers or timelines [20][22]. Question: Inventory control and macroeconomic impacts - Management clarified that current macroeconomic issues are not affecting inventory, which is well-stocked to meet demand [25][26]. Question: Drivers behind Q1 revenue and customer contributions - U.S. Renal Care was the primary driver of revenue, accounting for over 80% of shipments, with growth also seen in smaller customers and hospitals [30][31]. Question: Reimbursement negotiations with Medicare Advantage - Management expects to enter negotiations with MA plans during TDAPA coverage, with 40% of claims currently from MA plans [46][47]. Question: Inpatient segment growth potential - Management indicated that the inpatient segment has potential for growth but is difficult to quantify at this stage [52][53].

As filed with the Securities and Exchange Commission on September 25, 2024. Registration No. 333- UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 __________________________________________ APIMEDS PHARMACEUTICALS US, INC. (Exact name of registrant as specified in its charter) __________________________________________ | Delaware | 2834 | 85-1099700 | | --- | --- | --- | | (State or other jurisdiction of | (Primary Stand ...