CRB-701 (Nectin-4 Targeting ADC) - Clinical data readouts are expected for CRB-701 in the second half of 2025, with complete dose optimization and RP2D determination expected in Q4 2025[5] - CRB-701 is designed to address unmet needs of PADCEV® by extending ADC half-life to reduce dosing frequency and enabling higher doses due to lower DAR and longer half-life[10] - Phase 1 dose escalation studies are ongoing, with continued expansion at 2 doses and dose optimization planned for HNSCC, cervical, and bladder tumors[17, 18] - In Phase 1 dose escalation studies, ocular toxicity was reduced from 66% in CSPC cohorts to 38% in Corbus cohorts through the use of prophylaxis and baseline selection[32] - Emerging combined safety profile of CRB-701 shows a Grade 3 or higher AE rate of 20% (n=15/75), compared to 58% for PADCEV® (n=179 of 310)[33] - Phase 1 data shows an ORR of 27% and DCR of 77% in Corbus patients (n=26), and an ORR of 28% and DCR of 68% in CSPC patients (n=25)[38] - In mUC patients, CRB-701 showed an ORR of 44% (4 out of 9) and a DCR of 78% (7 out of 9)[48] - In cervical cancer patients, CRB-701 showed an ORR of 43% (3 out of 7) and a DCR of 86% (6 out of 7)[52] - In HNSCC patients, CRB-701 showed an ORR of 4 out of 7 patients and a DCR of 6 out of 7 patients[57] Financials - As of March 31, 2025, the company had $133 million in cash, cash equivalents, and investments, with approximately 122 million common shares outstanding (~140 million fully-diluted shares)[5]

Pipeline Development - Pilavapadin (LX9211) Phase 2b PROGRESS study identified the 10 mg dose as the most clinically meaningful for DPNP[13], with post-hoc analysis showing statistically significant pain reduction compared to placebo (p = 0.04) in combined 10 mg dosing arms[16] - The PROGRESS study enrolled 496 patients[12], and the 10 mg dose had a completion rate of 87.8%[18], similar to the placebo group's 87.9%[18] - LX9851 IND-enabling studies are underway for obesity and related metabolic disorders[6], showing potential for weight loss maintenance after semaglutide discontinuation in preclinical studies[34] - SONATA-HCM Phase 3 trial is enrolling globally to evaluate sotagliflozin in both obstructive and non-obstructive HCM patients[21, 29] Sotagliflozin & INPEFA - Sotagliflozin has shown a 0.77 hazard ratio (95% CI 0.65-0.91, p=0.0020) for reduced major adverse cardiovascular events (MACE) in patients with T2D, CKD, and high CV risk[23] - Approximately 1.1 million people in the U.S. have HCM[26, 27], presenting a significant market opportunity for sotagliflozin[26] - Viatris is undertaking ex-US, ex-EU registration and regional development of sotagliflozin[21] Market Opportunity & Partnerships - Approximately 9 million U.S. patients have progressive DPNP[20], with 60% experiencing moderate-to-severe pain and low satisfaction with current treatments[20] - Lexicon entered an exclusive licensing agreement with Novo Nordisk for LX9851, receiving $75 million in upfront and near-term milestones, with potential for up to $1 billion in aggregate payments[40] - Lexicon entered an exclusive licensing agreement with Viatris for sotagliflozin outside the U.S. and Europe, receiving $25 million upfront, with potential for almost $200 million in milestone payments[40]

Industry Challenge - Clinical trial bottlenecks cause delays in new drug launches [1] AI Solution - AI-enabled technology aims to accelerate the clinical trial process [1] Company Focus - Two cancer doctors developed the AI solution [1]

Investment Ratings - Bristol-Myers Squibb (BMY): Neutral [6] - Eli Lilly (LLY): Buy [10] - Novartis (NOVN): Neutral [16] - Sanofi (SNY): Neutral [17] - Biogen (BIIB): Buy [20] - Insmed Therapeutics (INSM): Buy [25] - Jazz Pharmaceuticals (JAZZ): Buy [29] - MoonLake Immunotherapeutics (MLTX): Buy [36] Core Insights - The report emphasizes the importance of idiosyncratic catalysts in the biopharma sector, particularly in the context of macroeconomic volatility and healthcare policy uncertainty [1] - Key catalysts to watch in 3Q25 include pivotal studies from various companies, with a focus on Alzheimer's disease, obesity, Sjogren's syndrome, multiple sclerosis, and gastroesophageal adenocarcinoma [1][5] - The report highlights the potential for significant market opportunities based on upcoming trial results and regulatory approvals, particularly for drugs like Cobenfy, orforglipron, ianalumab, tolebrutinib, and zanidatamab [1][5][10][18][30] Summary by Company Bristol-Myers Squibb (BMY) - Monitoring Phase 3 data from the Cobenfy ADEPT-2 trial in Alzheimer's disease psychosis, with a primary completion date in July [8] - The trial's success could have implications for a large patient population, with approximately 6 million Alzheimer's patients in the U.S. [8][9] Eli Lilly (LLY) - Focus on the ATTAIN-1 trial for orforglipron in obesity without diabetes, with results expected in July [10] - Anticipated weight loss efficacy in the 12-15% range, with safety and tolerability being key metrics [13] Novartis (NOVN) - Key focus on ianalumab's readouts in Sjogren's syndrome and immune thrombocytopenia, with a potential peak sales opportunity of approximately $2 billion [18] Sanofi (SNY) - Expected data from the Phase 3 PERSEUS trial of tolebrutinib in primary progressive multiple sclerosis, with a primary completion date in July [19] Biogen (BIIB) - Monitoring Leqembi's commercial trajectory in early-onset Alzheimer's disease, with a potential peak sales of approximately $800 million [21] Insmed Therapeutics (INSM) - Regulatory review of brensocatib for bronchiectasis, with a PDUFA date of August 12 [25] - Potential for significant upside if approved with a broad label [27] Jazz Pharmaceuticals (JAZZ) - Anticipating topline data from the HERIZON-GEA-01 trial for zanidatamab in gastroesophageal adenocarcinoma, with a potential peak sales opportunity exceeding $2 billion [30] MoonLake Immunotherapeutics (MLTX) - Reporting topline results from the Ph. 3 VELA trials for sonelokimab in hidradenitis suppurativa, with expectations for best-in-class efficacy [36]

New drugs take too long to get to market because of clinical trial bottlenecks. Two cancer doctors built AI-enabled tech to speed up the process. (Photo: Maria Ponce) https://t.co/h2z5abwqHe https://t.co/7k3mmUwhfT ...

Financial Data and Key Metrics Changes - The company has a strong balance sheet with over $190 million in cash, providing a runway through the first half of 2028 [4][22] - The company has extended its cash runway by a quarter and a half since the transaction with Biogen [6] Business Line Data and Key Metrics Changes - The company has three assets in clinical development: ATI-2138, ATI-45, and ATI-52, with ongoing studies in various indications [3][4] - ATI-45 is in phase three clinical studies in China for severe asthma and CRS with NP, and phase two studies in COPD [4] - A global phase two study in atopic dermatitis has been initiated, with sites in the US, Canada, and Europe [5][14] Market Data and Key Metrics Changes - The pipeline includes highly differentiated large and small molecule assets targeting multibillion-dollar addressable markets [4] - The company is actively seeking partners for ATI-45 in respiratory indications outside of China [14][15] Company Strategy and Development Direction - The company focuses on developing best-in-class therapeutics with a strong emphasis on both large and small molecule drug development [3] - Future plans include reporting top-line data from various studies in 2026, including those for ATI-2138 and ATI-45 [6][7][13] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the clinical progress and the potential of their pipeline, highlighting a rich catalyst calendar expected in 2026 [6][22] - The company aims to demonstrate the unique pharmacology and safety profile of its assets, particularly in atopic dermatitis and alopecia areata [20][21] Other Important Information - The company has made significant progress in clinical and preclinical plans since the transaction with Biogen [6] - The IND for the bispecific antibody ATI-52 was recently allowed, and phase one SADMAD work has begun [5][17] Q&A Session Summary Question: What are the next steps for the clinical studies? - The company plans to report top-line data from the phase two study of ATI-2138 imminently and initiate a clinical study in alopecia areata [6][20] Question: How does ATI-45 compare to competitors? - Management highlighted that ATI-45 has demonstrated enhanced potency compared to competitors like tezepelumab, with a greater than 60x inhibition of CCL 17 production [9][12] Question: What is the timeline for the next gen ITK selective molecule? - The company plans to file an IND for the next gen ITK molecule in 2026 and begin phase one work shortly thereafter [21][22]

Core Viewpoint - Moleculin Biotech, Inc. has announced a public offering of 16,080,000 shares of common stock and Series E warrants, priced at $0.37 per share, aiming to raise approximately $5.9 million to advance its drug development pipeline [1][2]. Group 1: Offering Details - The public offering includes 16,080,000 shares of common stock and Series E warrants to purchase up to 48,240,000 shares, with a combined offering price of $0.37 per share [1]. - The offering is expected to close on or about June 23, 2025, subject to customary closing conditions [2]. - Gross proceeds from the offering are anticipated to be approximately $5.9 million before deducting fees and expenses [2]. Group 2: Use of Proceeds - The net proceeds from the offering will be used to advance the development of Annamycin and two other drug portfolios through clinical development [2]. - Funds will also support preclinical studies and research sponsorship, as well as working capital needs [2]. Group 3: Company Overview - Moleculin Biotech, Inc. is a late-stage pharmaceutical company focused on developing therapies for hard-to-treat tumors and viruses, with its lead program Annamycin targeting relapsed or refractory acute myeloid leukemia (AML) and soft tissue sarcoma [6][7]. - The company is conducting the MIRACLE trial, a pivotal Phase 3 study evaluating Annamycin in combination with cytarabine for AML treatment [7]. - Additionally, Moleculin is developing WP1066, an immune/transcription modulator for various cancers, and a portfolio of antimetabolites including WP1122 for treating pathogenic viruses [8].

Company Overview - Aligos Therapeutics, Inc. is a clinical stage biopharmaceutical company focused on developing therapies for liver and viral diseases [3] - The company aims to improve patient outcomes through its science-driven approach and deep R&D expertise [3] Leadership Appointment - Kieron Wesson, PhD, has been appointed as Vice President, Head of Chemistry Manufacturing Controls (CMC) at Aligos, effective immediately [1] - Dr. Wesson brings over 20 years of experience in pharmaceutical development, having previously held leadership roles at Kezar Life Sciences and AN2 Therapeutics [2] - His expertise will provide leadership and oversight on all CMC-related matters as Aligos prepares to begin its Phase 2 study of ALG-000184 in mid-2025 [2] Pipeline and Research Focus - Aligos is advancing a purpose-built pipeline targeting high unmet medical needs, including chronic hepatitis B virus infection and metabolic dysfunction-associated steatohepatitis (MASH) [3] - The company is set to initiate a Phase 2 clinical study for its therapeutic candidate ALG-000184 in mid-2025 [2]

Core Viewpoint - Biogen Inc. has initiated the BRAVE study, a global Phase 3 clinical trial to evaluate the efficacy and safety of omaveloxolone in children with Friedreich ataxia (FA) aged 2 to under 16 years, addressing a significant unmet need in the pediatric population [1][2][3]. Group 1: Study Design and Objectives - The BRAVE study will involve approximately 255 children with FA, randomized in a 2:1 ratio to receive either omaveloxolone or placebo for 52 weeks, followed by an open-label extension phase [2][4]. - The primary outcome measure is the change from baseline in the Upright Stability Score (USS), recognized as a sensitive measure of disease progression in children with FA [2][3]. - The study design has been informed by previous research and input from the FA community, with enrollment starting in the U.S. and plans to expand globally [4]. Group 2: Current Product Information - Omaveloxolone, marketed as SKYCLARYS, is currently approved for the treatment of FA in adults and adolescents aged 16 years and older in over 40 countries, including the U.S. and the European Union [1][5]. - The drug has received Orphan Drug, Fast Track, and Rare Pediatric Disease Designations from the U.S. FDA, highlighting its significance in treating this rare condition [5]. Group 3: Disease Context - Friedreich ataxia is a rare, genetic, life-shortening neuromuscular disorder, with early symptoms typically appearing in childhood and leading to significant disability [7][8]. - Patients with early onset FA often experience a more aggressive disease progression, underscoring the critical need for effective treatments in the pediatric population [3][7].

Teva Pharmaceutical Industries (TEVA) 2025 Conference Summary Company Overview - Teva Pharmaceutical Industries is focusing on a growth strategy initiated in 2023, emphasizing innovative medicines, pipeline advancements, generics, and business focus [2][3] Key Business Developments - Teva has experienced nine consecutive quarters of growth and is entering a new acceleration phase from 2025 to 2027 [3] - Key commercial assets include AUSTEDO, Yuzetti, and AJOVY, which are significant drivers for the company [3] AUSTEDO Insights - AUSTEDO is projected to achieve peak sales of over $3 billion, driven by an unmet need in the treatment of tardive dyskinesia (TD) [6][7] - Approximately 800,000 patients in the U.S. have TD, with only 15% diagnosed and 5-6% currently treated, indicating a substantial market opportunity [7] - AUSTEDO has seen 40% growth and 23% increase in total prescriptions (TRxs) [7] - Teva has invested in direct-to-consumer marketing to raise awareness and has filed for approval in Europe [8] Competitive Landscape - Teva views the competition with Neurocrine's INGREZZA as a collaborative effort to increase patient treatment rather than direct competition [9] - AUSTEDO maintains broad coverage, with patients paying an average of less than $10 out of pocket [10] Long-Acting Injectable (LAI) Developments - Teva is excited about the EZEDI long-acting injectable, which offers significant advantages for patient compliance and rapid relief [15][16] - The company aims to capture market share from existing LAIs like risperidone and paliperidone [16][19] - The long-acting olanzapine is expected to have a favorable launch trajectory, potentially faster than Yuzetti due to pent-up demand [20][21] TL1A Pipeline - TL1A is a promising new biologic targeting inflammatory pathways, with potential applications in ulcerative colitis and Crohn's disease [35][36] - The molecule has shown high efficacy in Phase II studies, with low rates of anti-drug antibodies [37][38] - Upcoming data updates are expected in the first half of 2026, focusing on maintenance data [40][41] DARE Program - The Dual Action Rescue Inhaler (DARE) targets the significant unmet need in asthma exacerbations, with a focus on combination therapies [57][58] - Teva is conducting the largest asthma study to date, aiming for broad labeling that includes pediatric populations [59][60] Market and Regulatory Considerations - Teva is actively managing tariff exposure, with a strong manufacturing presence in the U.S. and limited exposure to China and India [65][66] - The company has taken proactive measures to ensure inventory levels are sufficient to navigate potential market disruptions [67] Conclusion - Teva is positioned for growth with a robust pipeline and strategic focus on innovative therapies, while navigating competitive and regulatory landscapes effectively. The company remains committed to addressing significant unmet medical needs across its product offerings.