Core Insights - Ocular Therapeutix is preparing to present topline results from the SOL-1 Phase 3 superiority trial for AXPAXLI™ in wet AMD at the 49 Macula Society Annual Meeting scheduled for February 25-28, 2026 [1][3] - The company plans to submit a New Drug Application (NDA) for AXPAXLI based on the SOL-1 52-week data, contingent on positive results and discussions with the FDA [1][3] - The SOL-R Phase 3 non-inferiority trial has completed randomization of 631 subjects, with topline results expected in Q1 2027 [1][3] - Ocular has a cash balance of $737.1 million as of December 31, 2025, which is projected to support operations into 2028 [1][5] Business Highlights - The SOL-1 trial is designed to evaluate the safety and efficacy of AXPAXLI in treating wet AMD, with a primary endpoint focused on maintaining visual acuity [3][16] - The SOL-R trial aims to demonstrate non-inferiority compared to aflibercept, with a primary endpoint at Week 56 [3][19] - The HELIOS-3 trial for diabetic retinopathy is currently underway, with a focus on subjects with moderately severe to severe non-proliferative diabetic retinopathy [4][24] Financial Performance - Total net revenue for Q4 2025 was $13.3 million, a decrease of 22.4% from $17.1 million in Q4 2024 [6] - For the full year 2025, total net revenue was $52.0 million, down 18.5% from $63.7 million in 2024 [6] - Research and development expenses increased to $50.8 million in Q4 2025 from $41.0 million in Q4 2024, reflecting ongoing clinical trial costs [7] - The company reported a net loss of $(64.7) million for Q4 2025, consistent with a net loss of $(48.4) million in Q4 2024 [10] Future Developments - The SOL-X open-label extension trial is expected to begin in Q2 2026, allowing subjects from SOL-1 and SOL-R to enroll for additional safety follow-up [3][21] - The company raised approximately $475 million from an equity offering in September 2025, with net proceeds supporting operations into 2028 [4]

Summary of Plus Therapeutics Conference Call - January 22, 2026 Company Overview - **Company**: Plus Therapeutics (NasdaqCM:PSTV) - **Focus**: Development of CNSide and RIOVA clinical programs Key Points Financial Update - **Recent Offering**: Completed a $15 million oversubscribed financial offering on January 14, 2026, which extends the company's runway through 2027 [4] - **Use of Funds**: Funds will be used to expand CNSide investments to achieve break-even by 2027 and to complete ongoing phase II RIOVA clinical trials [4] RIOVA Clinical Program - **FDA Interaction**: Positive feedback from a Type B meeting with the FDA in November 2025, which will expedite RIOVA clinical development timelines [5] - **Trial Design**: Agreement on a randomized pivotal trial design focusing on neurologic condition improvements, patient-reported outcomes, and overall survival as key endpoints [6] - **2026 Goals**: Aim to identify optimal RIOVA dosing regimes and expand into a 12-patient dose expansion arm for additional safety and efficacy data [7] - **Enrollment Progress**: On track to complete phase II enrollment for recurrent glioblastoma (GBM) with data expected in Q4 2026 [7] CNSide Commercialization - **Licensure**: Achieved state licensure in 49 of 50 U.S. states, with agreements covering 67 million lives through partnerships with UnitedHealthcare and Humana [8] - **2026 Focus**: Targeting over 150 million covered lives through additional payer agreements, obtaining Medicare and Medicaid coverage, and ramping up testing utilization to reestablish previous commercial run rates of 1,250 tests per year [8] - **Physician Engagement**: Goal to establish a base of 50 unique ordering physicians, with a long-term target of reaching 200 [28] Operational Insights - **Testing Goals**: Aiming for 1,250 tests per year as a minimum goal, which is expected to cover only a quarter of the path to profitability; a target of 5,000 tests is needed for full profitability [31] - **Cost Efficiency**: Significant opportunities for automation and cost reductions have been identified since acquiring testing assets from the previous company [32] Strategic Outlook - **Market Positioning**: Emphasis on improving diagnostic capabilities with CNSide and bringing the RIOVA drug to market to address unmet medical needs in CNS cancers [35] - **Future Announcements**: Management is optimistic about upcoming announcements that could positively impact stock performance, with no immediate plans for a reverse stock split [19] Risk Factors - **Forward-Looking Statements**: The company has cautioned that actual results may differ from expectations due to various risks outlined in their SEC filings [3] Additional Considerations - **Payer Dynamics**: The company is working on obtaining PLA and DEX Z-Codes for Medicare and Medicaid coverage, which are crucial for expanding market access [26] - **Patient Demographics**: Noted that the demographic for CNSide testing skews younger, with a 60/40 split between private payers and Medicare [27] This summary encapsulates the critical updates and strategic direction of Plus Therapeutics as discussed in the conference call, highlighting both opportunities and challenges ahead.

Core Insights - Investors in biotechnology company Viking Therapeutics experienced significant volatility in 2025, primarily influenced by clinical trial data perceptions [1] Company Overview - Viking Therapeutics' lead drug candidate is VK2735, a Dual GLP-1/GIP agonist aimed at treating diabetes and obesity, competing with established drugs like Novo Nordisk's Wegovy and Eli Lilly's Zepbound [2] Drug Development - VK2735 is being developed in both subcutaneous and oral forms, with the oral version being particularly attractive due to patient preference for pills, ease of storage, and administration [3] 2025 Developments - In August 2025, the Phase 2 VENTURE trial results for oral VK2735 were disappointing, showing a 12.2% weight loss at 13 weeks but raising concerns over safety and tolerability, highlighted by a 20% discontinuation rate due to adverse events [4][5] Market Reaction - Following the initial negative results, Viking Therapeutics' stock began to recover as investors refocused on the company's potential, with optimism stemming from the possibility of overly high expectations for the VENTURE trial based on prior Phase 1 results [7] Trial Insights - The VENTURE trial's aggressive titration rate and short duration may have contributed to the high discontinuation rate, which was 20% in the treatment group compared to 13% in the placebo group, indicating potential challenges within the trial cohort [9] Future Prospects - Viking has completed patient enrollment for a trial testing the oral form of VK2735 as a maintenance dose following an initial subcutaneous dose, suggesting ongoing commitment to the drug's development [10]

Core Viewpoint - The proposed merger between Ai Technology Group Inc. and AVM Biotechnology Inc. is progressing, with funding timelines being extended to facilitate corporate growth and financial audits in 2026 [2] Group 1: Merger and Funding - The Company is funding the proposed merger with AVM on an exclusive basis and is extending funding dates to accommodate the merger and financial audit timelines [2] - The planned merger is expected to enhance the corporate growth of the combined entities [2] Group 2: Clinical Trials and Drug Development - AVM has resumed its FDA Phase 2 Clinical Trial for relapsed and refractory Non-Hodgkins Lymphoma, known as the OPAL Trial, for its drug AVM0703, with plans to enroll an additional 7-10 patients [3] - AVM0703 has been administered in cycles of 3-4 weeks for up to 9 repeat infusions without cumulative safety concerns, with promising survival data accumulating from 30 subjects over almost four years [3] - AVM also runs an FDA Expanded Access Program for various solid tumors and blood cancers, with over 19 repeat infusions administered and follow-up extending beyond 5 years [4] Group 3: Funding and Grants - More than 92 patients have received over 297 total infusions of AVM0703 without safety concerns, yielding exciting outcomes [5] - AVM has secured an additional US$2 million NCI SBIR grant, bringing total government grant funding to US$6.4 million [5]

Core Insights - Reviva Pharmaceuticals announced the publication of findings from the RECOVER Phase 3 trial, highlighting the efficacy of brilaroxazine in treating schizophrenia, particularly its impact on negative symptoms and other symptom domains [1][2] - The study emphasizes the use of speech latency as a novel biomarker that can enhance clinical trial outcomes by improving patient stratification and reducing sample sizes [2][4] Company Overview - Reviva Pharmaceuticals is a late-stage biopharmaceutical company focused on developing therapies for unmet medical needs in central nervous system (CNS), inflammatory, and cardiometabolic diseases [9] - The company's pipeline includes brilaroxazine and another candidate, RP1208, both of which are new chemical entities discovered in-house [9] Clinical Trial Findings - The RECOVER Phase 3 trial successfully met all primary and secondary endpoints, showing statistically significant reductions in major symptom domains, including negative symptoms, with a 50 mg dose of brilaroxazine compared to placebo [6] - Brilaroxazine demonstrated a well-tolerated side effect profile, with discontinuation rates lower than those observed in the placebo group [6] Biomarker Insights - Speech latency, an objective measure of verbal response time, effectively differentiates between patients with moderate-to-severe and low negative symptoms across various demographics [4][7] - VBM-positive patients exhibited a strong treatment response to brilaroxazine, particularly in negative symptoms, as assessed by clinician evaluations [7] Future Development - Reviva plans to explore brilaroxazine for additional neuropsychiatric indications, including bipolar disorder, major depressive disorder (MDD), and attention-deficit/hyperactivity disorder (ADHD) [6][8] - The company has received Orphan Drug Designation from the FDA for brilaroxazine in treating pulmonary arterial hypertension (PAH) and idiopathic pulmonary fibrosis (IPF) [8]

Core Insights - HUTCHMED (China) Limited announced positive data from the Phase 3 registration part of the ESLIM-02 clinical trial for sovleplenib in adult patients with warm antibody autoimmune hemolytic anemia (wAIHA) [1][4] Clinical Trial Results - The ESLIM-02 trial met its primary endpoint of durable hemoglobin response rate between weeks 5 to 24 of treatment [2] - The overall response rate was 43.8% in the first 8 weeks and 66.7% during the 24 weeks of treatment, compared to 0% in the placebo group [4] - The study included patients who had relapsed or were refractory to at least one prior line of standard treatment [3] Disease Prevalence and Impact - The incidence of autoimmune hemolytic anemia (AIHA) is estimated at 0.8-3.0 per 100,000 adults annually, with a prevalence of 17 per 100,000 adults and a death rate of 8-11% [2] - wAIHA accounts for approximately 75-80% of all adult AIHA cases [2] Regulatory Plans - HUTCHMED plans to submit a New Drug Application for sovleplenib for wAIHA to the China National Medical Products Administration (NMPA) in the first half of 2026 [4] Competitive Landscape - Novartis AG reported results from the VAYHIT2 Phase 3 trial showing that ianalumab plus eltrombopag had a median time to treatment failure 2.8 times longer than placebo plus eltrombopag [6] - CRISPR Therapeutics AG initiated a Phase 1 trial of its allogeneic CAR T therapy in ITP and wAIHA [6] Other Developments - HUTCHMED initiated the Phase 3 part of a trial for a combination treatment for metastatic pancreatic ductal adenocarcinoma [7] - HUTCHMED shares increased by 5.09% to $14.45 during premarket trading [7]

Core Insights - Several biotechnology and pharmaceutical companies experienced significant stock price increases in after-hours trading due to clinical trial updates, regulatory advancements, and investor anticipation for upcoming data releases [1] Company Updates - Alumis Inc. (ALMS) saw a surge of 17.33% to $9.75, gaining $1.44 after announcing that topline data from its Phase 3 ONWARD clinical program for envudeucitinib in moderate-to-severe plaque psoriasis will be reported on January 6, 2026, along with a conference call to discuss the results [2] - Genelux Corp. (GNLX) climbed 10.92% to $3.86, up $0.38, following interim results from ongoing trials evaluating Olvi-Vec in patients with progressive small cell lung cancer (SCLC) and non-small cell lung cancer (NSCLC) [3] - Bright Minds Biosciences Inc. (DRUG) rose 8.42% to $86.75, gaining $6.74, and announced a conference call on January 6, 2026, to report topline results from its Phase 2 trial of BMB-101 in patients with drug-resistant Absence Seizures [4] - Context Therapeutics Inc. (CNTX) shares increased by 8.36% to $1.68, adding $0.13, despite no specific news released [4] - BioAtla, Inc. (BCAB) gained 3.95% to $0.44, up $0.017, after announcing a special purpose vehicle transaction to advance ozuriftamab vedotin in a Phase 3 study for oropharyngeal squamous cell carcinoma, receiving $5 million in initial funding [5] - Femasys Inc. (FEMY) added 7.09% to $0.6223, up $0.04, with no new updates reported [5] - Acumen Pharmaceuticals, Inc. (ABOS) jumped 11.62% to $2.21, gaining $0.23, also without new corporate updates [6] - Alpha Tau Medical Ltd. (DRTS) rose 5.36% to $5.50, up $0.28, after submitting the first module of its pre-market approval application to the FDA for Alpha DaRT in treating recurrent cutaneous squamous cell carcinoma [7]

Core Insights - Neurocrine Biosciences announced that its Phase 3 KINECT-DCP study of valbenazine for dyskinetic cerebral palsy did not meet primary or key secondary endpoints [1][2] Company Overview - Neurocrine Biosciences is a biopharmaceutical company focused on neuroscience, dedicated to developing treatments for neurological, neuroendocrine, and neuropsychiatric disorders [7] - The company has a portfolio that includes FDA-approved treatments for tardive dyskinesia and chorea associated with Huntington's disease, among others [7] Study Details - The KINECT-DCP study was the largest double-blind placebo-controlled trial for dyskinetic cerebral palsy, evaluating 14 weeks of valbenazine treatment against placebo [2][5] - The primary objective was to assess the efficacy of valbenazine in improving chorea in participants aged 6 to 70 years with dyskinetic cerebral palsy [5] Drug Information - Valbenazine is a selective vesicular monoamine transporter 2 (VMAT2) inhibitor, previously approved for tardive dyskinesia and more recently for chorea associated with Huntington's disease [6] - The safety profile of valbenazine in the study was consistent with established data [2]

Core Viewpoint - Tvardi Therapeutics, Inc. experienced a significant decline in stock value, dropping over 80% following disappointing preliminary data from its Phase 2 REVERT clinical trial for TTI-101 in idiopathic pulmonary fibrosis [5]. Group 1: Company Overview - Tvardi Therapeutics, Inc. is a publicly traded company listed on NASDAQ under the ticker TVRD [4]. - The company is currently under investigation by Faruqi & Faruqi, LLP, a national securities law firm, for potential claims related to the significant losses suffered by investors [4]. Group 2: Clinical Trial Results - The Phase 2 REVERT clinical trial aimed to evaluate the safety, pharmacokinetics, and exploratory outcomes related to lung function of TTI-101 [5]. - Preliminary data indicated that the trial did not meet its goals, with changes in Forced Vital Capacity (FVC) not showing the expected efficacy [5]. - The baseline characteristics of patients were similar across treatment arms, except for a lower percent predicted FVC in the placebo group compared to those treated with TTI-101 [5].

Core Insights - Tenax Therapeutics announced that the Blinded Sample Size Re-estimation (BSSR) of the LEVEL trial shows it is adequately powered to detect a 25-meter change in the 6-minute walk distance (6MWD), confirming that the target enrollment remains unchanged and is expected to complete in the first half of 2026 [1][2][3] Group 1: LEVEL Study Details - LEVEL is a Phase 3 clinical trial evaluating TNX-103 (oral levosimendan) for patients with pulmonary hypertension in heart failure with preserved ejection fraction (PH-HFpEF) in the U.S. and Canada [2] - The BSSR results indicated that the observed change in 6MWD from the first 150 randomized patients was less than the assumed 55 meters [2] - The company expects to share topline data in the second half of 2026 and remains confident in executing its Phase 3 development plan for TNX-103 [3] Group 2: LEVEL-2 Study Initiation - Tenax has initiated LEVEL-2, a global Phase 3 study of TNX-103, aiming to enroll approximately 540 PH-HFpEF patients with a 2:1 randomization to receive TNX-103 or placebo [3][4] - The primary endpoint for LEVEL-2 is the change in 6MWD at Week 26, with secondary endpoints including changes in Kansas City Cardiomyopathy Questionnaire (KCCQ) and New York Heart Association (NYHA) Functional Class [3] Group 3: Global Study Sites and Safety Observations - Over 100 sites across 15 countries have been selected for participation in LEVEL-2, with a rigorous process implemented to ensure consistency in patient hemodynamic assessments [4] - The LEVEL-2 study includes a 6-month blinded safety observation following the 26-week efficacy assessment to provide a robust safety database for regulatory review [4] Group 4: Levosimendan Overview - Levosimendan is a first-in-class K-ATP channel activator/calcium sensitizer being evaluated for treating PH-HFpEF, with market authorization in 60 countries for intravenous use in acutely decompensated heart failure [5] - The Phase 2 HELP study demonstrated the potential of both intravenous (TNX-101) and oral (TNX-103) formulations to improve exercise capacity and quality of life in patients with PH-HFpEF [5] Group 5: Company Background - Tenax Therapeutics is a Phase 3 development-stage pharmaceutical company focused on novel cardiopulmonary therapies, holding global rights to develop and commercialize levosimendan for PH-HFpEF, which currently lacks approved treatments [7]