Smartkarma Daily Briefs

• Mayne Pharma’s acquisition by Cosette Pharmaceuticals faces challenges due to claims of material adverse changes, including financial performance and litigation issues.
• Australian activist fund Harvest Lane Asset Management is building a position in MYX, arguing Cosette lacks grounds to terminate the deal.
• Recent developments include FDA issue resolution, countersuit against TherapeuticsMD, and potential for a modest price cut agreement.

• Eli Lilly and Company has made a decisive move to expand its footprint in neuroscience and pain management by announcing its acquisition of SiteOne Therapeutics, a clinical-stage biotech focused on developing non-opioid pain treatments.
• The deal, valued at up to $1 billion including milestones, centers around STC-004, a Phase 2-ready NaV1.8 inhibitor that could become a next generation oral pain medication.
• The acquisition underscores Lilly’s broader ambition to lead in addiction-free, chronic pain solutions at a time when regulatory and societal pressures around opioid misuse continue to rise.

• Medical Data Vision [MDV] reported FY25 Q1 (Dec year-end) results with sales coming in largely in line with the firm’s guidance while operating profit [OP] was higher than expected.
• The firm produced Q1 gross profit [GP] of1,085mil (+3.8% YoY) and OP of ¥17mil (-67.6% YoY) on sales of ¥1,532mil (+10.4% YoY).
• Ther firm’s profit targets remain unchanged, guiding for FY25 OP of ¥2,600mil and RP of ¥2,500mil.

• Pharmaessentia Corp (6446 TT) reported record-high revenue, operating, and net profits in 1Q25. Revenue hit new highs for eight consecutive quarters, with revenue CQGR standing at 18% during 1Q23–1Q25.
• Continued sequential improvement in profitability is one of the key highlights of 1Q25 result. Pharmaessentia has turned profitable at both operating and net level for the first time in 2024.
• Geography and indication expansion of Besremi, and pipeline progress will remain growth engines. Potential BLA submission of Besremi for ET and Besremi pen launch in 2025 are the near-term catalysts.

• Omada Health is expected to IPO this week. The company’s amended prospectus puts the expected price range per share at $18 to $20, implying a market cap of ~$1.1B.
• Omada Health is a virtual-first healthcare provider, supporting people with chronic conditions: prediabetes, diabetes (T2D), hypertension, obesity and musculoskeletal.
• A digital care provider stayed private for longer. Its direct competitor, Livongo Health, went public in 2019 and was acquired by Teladoc Health for ~$18.5B in 2020.

• Interventional psychiatry clinic landscape evolving for the better.
• The interventional psychiatry landscape has significantly evolved over the past five years, with the emergence of ~5,000 clinics or mental health centers offering a range of services to patients from ECT and TMS to esketamine and regular ketamine.
• From Cybin’s interactions with these centers, they appear to be well prepared for potential dosing and treatment with psychedelics like Cybin’s CYB003 as they come to market. 

• The toxicology studies program for its lead TYK2/JAK1 inhibitor, SDC-1801, are starting.
• In 2024, SDC-1801 which is a dual inhibitor targeting autoimmune diseases, completed Phase 1 clinical trials in healthy volunteers which demonstrated a favorable safety and pharmacokinetic profile.
• These toxicology studies are the next key regulatory milestone on the pathway to a Phase 2 development programme.

• Grace is a clinical-stage, biotechnology company focused on rare disease.
• Its lead program, GTx-104, is a novel injectable formulation of nimodipine for the treatment of aneurysmal subarachnoid hemorrhage (aSAH).
• Other programs include GTX-102 for Ataxia Telangiectasia & GTX-101 for postherpetic neuralgia.

OSE has announced plans to strengthen its growth strategy and accelerate the key pillars of its pipeline, covering immuno-inflammation and immuno-oncology. In the inflammation space, the company revealed a potential path forward for lusvertikimab, which reported positive top-line data in Phase II (CoTikiS) for ulcerative colitis (UC) in Q424. A new predictive biomarker (a composite IL7R axis biomarker) has been identified through a retrospective analysis of CoTikiS, offering potential to improve clinical remission rates through a precision medicine approach with lusvertikimab, for the biomarker-positive population. Management is preparing for a Phase IIb programme to validate this biomarker, with the aim of demonstrating efficacy in this population by 2027. If successful, this should lay the foundation for late-stage clinical development efforts for lusvertikimab. In the oncology space, the latest update confirmed that the company is on track with its plans for regulatory submission, with the pivotal Phase III non-small cell lung cancer trial due to conclude in 2027, with potential to expand the label to other indications (such as pancreatic cancer) in later years, contingent on successful clinical progression.

• A contract extension has been signed with an existing large pharma client.
• This builds upon the contract awarded in June 2024 and uses Physiomics’s proprietary Virtual Tumour platform to model the client’s targeted oncology agents in combination with other modalities helping inform dose and scheduling decisions.
• The contract extension continues this work and supports the client’s expansion into new oncology indications.