Inventiva (NasdaqGM:IVA) Q4 2025 Earnings call March 31, 2026 08:00 AM ET Speaker10Good day, and thank you for standing by. Welcome to the Inventiva Full Year 2025 Financial Report webcast and conference call. At this time, all participants are in listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during the session, you will need to press star 1 and 1 on your telephone. You will then hear an automated message advising your hand is raised. To w ...

Core Insights - Sagimet Biosciences has made significant progress in its clinical programs for MASH and acne, completing a Phase 1 PK trial of denifanstat and resmetirom, with plans to initiate a Phase 2 trial in F4 MASH patients in the second half of 2026 [1][2] - The company has secured a global, exclusive license for innovative forms of resmetirom active pharmaceutical ingredients from TAPI, enhancing its development capabilities [1][10] - Positive topline results from a Phase 3 trial of denifanstat for moderate to severe acne in China have been reported, supporting the NDA accepted by China's NMPA [1][10] Clinical and Regulatory Updates - The Phase 1 PK trial of denifanstat and resmetirom showed good tolerability with no serious adverse events, paving the way for further development in MASH patients with F4 fibrosis [5][10] - A first-in-human Phase 1 trial of TVB-3567, another FASN inhibitor for acne, is currently ongoing [1][5] - The company plans to explore the role of FASN inhibition in acne further in clinical development in 2026 [2] Financial Results - As of December 31, 2025, Sagimet reported cash, cash equivalents, and marketable securities totaling $113.1 million [10][21] - Research and development expenses for the year were $39.1 million, compared to $38.4 million in 2024, indicating a slight increase in investment in R&D [10][19] - The net loss for the year was $51.0 million, an increase from $45.6 million in 2024, reflecting ongoing investment in clinical trials and development [10][19] Upcoming Milestones - Sagimet plans to advance the denifanstat and resmetirom combination into a Phase 2 proof-of-concept trial for F4 MASH patients in the second half of 2026 [1][10] - Following the completion of the Phase 1 trial of TVB-3567, the company anticipates starting a Phase 2 trial in moderate to severe acne patients in 2026 [10][10]

Financial Data and Key Metrics Changes - The net loss for Q4 2025 was $27.4 million or $0.27 per share, compared to a net loss of $23.2 million or $0.33 per share in Q4 2024 [31][32] - R&D expenses in Q4 2025 were $18.4 million, down from $19.8 million in the same period of 2024, primarily due to the end of the phase 2b trial [30] - G&A expenses increased to $10.5 million in Q4 2025 from $5.1 million in Q4 2024, driven by a one-time charge related to executive transition [31] Business Line Data and Key Metrics Changes - The company is focused on advancing pemvidutide for liver diseases, particularly MASH, with promising results from phase 2 trials indicating strong therapeutic potential [6][9] - The phase 2 MASH study showed early resolution at 24 weeks and anti-fibrotic activity at 48 weeks, with significant improvements in liver fat and inflammation markers [9][17] Market Data and Key Metrics Changes - Market research indicated a high unmet need for therapies addressing tolerability issues in MASH patients, with many physicians seeking alternatives to existing treatments [25][26] - Over 70% of healthcare professionals surveyed expressed a high likelihood of prescribing pemvidutide, indicating strong market interest [28] Company Strategy and Development Direction - The company aims to strengthen its foundation for the advancement of pemvidutide and has enhanced its leadership team with expertise in liver disease and clinical development [11] - The phase 3 trial for pemvidutide is set to begin this year, with a focus on addressing both hepatic and metabolic drivers of MASH [20][22] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the potential of pemvidutide, especially after receiving FDA Breakthrough Therapy designation for MASH [10] - The company is preparing for the phase 3 trial while ensuring financial stability, with a cash position of approximately $340 million expected to support operations into 2028 [33][34] Other Important Information - The company has received valuable guidance from the FDA regarding the phase 3 trial design, which will include both biopsy-confirmed and non-invasive test cohorts [20][22] - The phase 2 trials for AUD and ALD are progressing well, with top-line data expected from the AUD trial in Q3 2026 [23][24] Q&A Session Summary Question: Can the FDA's new single pivotal framework save costs for the phase 3 trial? - Management indicated that the current approach remains unchanged and the single trial path for accelerated approval is still valid [38] Question: What are the statistical plans for the phase 3 trial? - The phase 3 trial is powered for two primary endpoints, with a sample size of around 990 patients, ensuring sufficient power for approval [41] Question: What is the FDA's stance on using non-invasive tests as registrational endpoints? - The FDA deemed it premature to consider non-invasive tests for approval, focusing instead on biopsy-driven endpoints [48] Question: What are the key elements locked in for the phase 3 protocol? - The protocol is nearing finalization, with critical elements like sample size and primary endpoints aligned, while ensuring comprehensive biopsy processes [85] Question: How will the company approach the AUD and ALD trials? - The company plans to assess AUD data and make decisions without waiting for ALD results, focusing on immediate next steps [93]

Financial Data and Key Metrics Changes - The net loss for Q4 2025 was $27.4 million or $0.27 per share, compared to a net loss of $23.2 million or $0.33 per share in Q4 2024, indicating an increase in losses year-over-year [31][32] - R&D expenses in Q4 2025 were $18.4 million, down from $19.8 million in the same period of 2024, primarily due to the completion of the Phase 2b trial [30] - G&A expenses increased to $10.5 million in Q4 2025 from $5.1 million in Q4 2024, driven by one-time charges related to executive transition and increased professional fees [31] Business Line Data and Key Metrics Changes - The company is focused on advancing pemvidutide for liver diseases, particularly MASH, with promising results from Phase 2 trials showing early MASH resolution and anti-fibrotic activity [9][16] - The Phase 2 AUD trial completed enrollment ahead of schedule, with top-line data expected in Q3 2026 [14][23] - The Phase 2 trial assessing pemvidutide in ALD is expected to complete enrollment in 2026 [14] Market Data and Key Metrics Changes - Market research indicated significant unmet needs among MASH patients, particularly for those who have discontinued semaglutide due to tolerability issues [25][26] - Physicians expressed a high unmet need for therapies that preserve lean muscle mass in MASH patients, highlighting the potential competitive advantage of pemvidutide [25][26] Company Strategy and Development Direction - The company aims to strengthen its foundation for the advancement of pemvidutide and has enhanced its leadership team with expertise in liver disease and late-stage clinical development [11] - A $75 million capital raise was completed to support the planned initiation of the Phase 3 trial for pemvidutide [12] - The company is preparing for a pivotal Phase 3 trial with a focus on MASH, aligning with FDA guidance on trial design and endpoints [20][22] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the potential of pemvidutide to address significant unmet needs in liver diseases, emphasizing its dual mechanism of action [6][9] - The company is committed to creating long-term value for shareholders while advancing its clinical programs [35] Other Important Information - The company reported total cash of $274 million at year-end 2025, with a pro forma cash position of approximately $340 million after recent capital raises [32][33] - The Phase 3 trial will enroll approximately 1,800 patients globally, with a focus on both biopsy-confirmed and non-invasive test-assessed MASH patients [21][22] Q&A Session Summary Question: Can the FDA's new single pivotal framework save costs for the Phase 3 trial? - Management indicated that the current approach remains unchanged and the path for approval is through a single trial for accelerated approval [36][38] Question: What are the statistical plans for the Phase 3 trial? - The study is powered for two primary endpoints, with a sample size of around 990 patients, ensuring sufficient power for approval [39][41] Question: What is the FDA's stance on using non-invasive tests as registrational endpoints? - The FDA deemed it premature to consider non-invasive tests for approval, focusing instead on biopsy-driven endpoints [47][48] Question: What are the key elements locked in for the Phase 3 protocol? - The protocol is nearing finalization, with critical elements like sample size and primary endpoints aligned, while finalizing biopsy details [86][87] Question: How will the company proceed with the AUD and ALD trials? - The company plans to assess AUD data and make decisions without waiting for ALD results, focusing on immediate next steps [93]

Summary of Sagimet Biosciences FY Conference Call Company Overview - **Company**: Sagimet Biosciences (NasdaqGM:SGMT) - **Focus**: Development of treatments for metabolic diseases, specifically targeting NASH (Non-Alcoholic Steatohepatitis) and acne Key Points Industry and Product Development - **NASH Treatment**: Sagimet is focusing on combination therapies for NASH, particularly using denifanstat, a FASN inhibitor, as a foundational treatment strategy [10][12] - **Combination Approach**: The company is exploring the combination of denifanstat with resmetirom, which has shown promising preclinical data indicating a synergistic effect in reducing inflammation and fibrosis [10][13][25] - **Clinical Data**: In patients with F4 stage disease, 11 out of 13 showed improvement in disease severity, indicating the effectiveness of denifanstat [12][13] Strategic Licensing and Development - **API License**: Sagimet has obtained a license for 20 novel forms of the resmetirom API from Teva, with no anticipated pharmacodynamic differences from the approved form [29][31] - **Selection Process**: The company is in the process of selecting the most effective version of resmetirom based on pharmacokinetics (PK), pharmacodynamics (PD), and solubility [40][41] Clinical Trials and Safety - **Phase 1 Study**: Completed with no safety signals reported, indicating compatibility and tolerability of the combination therapy [51][53] - **Phase 2 Plans**: The company plans to submit data from the Phase 1 study to EASL and is preparing for Phase 2 trials, which will not require new safety data for the new polymorph [57][127][128] Acne Treatment Development - **Market Size**: Approximately 50 million Americans suffer from acne, with 10 million having moderate to severe cases [184] - **Innovative Mechanism**: Sagimet's acne treatment aims to reduce sebum production, which is a novel approach compared to existing treatments [199][200] - **Phase 1 Study for Acne**: Initiated in June 2025, with expected readouts by the end of the year to inform Phase 2 program [205][206] Financial Outlook - **Cash Position**: As of the end of Q3, Sagimet reported $125 million, providing approximately two years of runway to support both MASH and acne programs [386] - **Milestone Payments**: Potential milestones from the Asian partner, Ascletis, could exceed $122 million, primarily based on commercial performance [378][380] Regulatory Considerations - **FDA Meetings**: The next critical step involves discussions with the FDA regarding the Phase 2 trial for MASH, expected in the first half of the year [156][160] - **Approval Timeline**: Anticipated approval from the NMPA for the Asian partner's product could occur within 10-16 months following NDA acceptance [376][377] Conclusion - **Dual Focus**: Sagimet is strategically prioritizing both MASH and acne treatment developments, leveraging its financial resources to advance both programs effectively [386][388]

Summary of MetaVia Inc. Conference Call Company Overview - **Company Name**: MetaVia Inc. - **Ticker Symbol**: MTVA - **Industry**: Clinical stage biotech focused on cardiometabolic diseases, specifically obesity and MASH (Metabolic Dysfunction-Associated Steatotic Liver Disease) [1][2] Core Points and Arguments Obesity Market Insights - Over 650 million adults globally are clinically obese, with the current obesity treatment market valued at approximately $10 billion, projected to grow to between $80 billion and $130 billion [3] - The MASH market is emerging, with analysts forecasting annual revenues between $20 billion and $35 billion [4] Product Development - **DA-1726**: An obesity drug currently in Phase I trials, showing promising early results with a 9.1% weight loss and 3.8 inches reduction in waist circumference over 8 weeks [9] - **Vanoglipol (DA-1241)**: A small molecule treatment for MASH, currently in Phase IIa trials, showing significant hepatic effects and well-tolerated in trials [12][25] Competitive Landscape - The obesity treatment space is highly competitive, with major players like Novo Nordisk and Madrigal Pharmaceuticals. Combination therapies are expected to dominate the market [4][27] - DA-1726 is positioned as a potential best-in-class drug, with a unique 3:1 ratio of GLP-1 to glucagon, aiming to achieve superior weight loss and glycemic control compared to competitors [16][20] Clinical Trial Updates - A new Phase I trial for DA-1726 is being initiated to explore higher dosages (up to 64 mg) to enhance efficacy and safety [10][11] - The company is actively seeking partnerships for both DA-1726 and Vanoglipol to enhance development and market entry [12][32] Financial Position - As of September 30, the company reported cash reserves of $14.3 million, with an additional $9 million raised in January [25] - The financial strategy includes maintaining a lean operational structure by leveraging partnerships with research centers in South Korea [13][14] Additional Important Information - The CEO emphasized the importance of conservative reporting of adverse events, noting that moderate vomiting was reported in 83.3% of participants, but this was counted conservatively [21][22] - The company is optimistic about the potential of both drugs and is preparing for data releases at major medical conferences throughout the year [12][26] Conclusion MetaVia Inc. is positioned in a rapidly growing market with promising drug candidates targeting obesity and MASH. The company is focused on advancing its clinical trials while maintaining a strong financial position and seeking strategic partnerships to enhance its market presence.

Lanifibranor's Potential - Lanifibranor is presented as a potential best-in-disease oral therapy for MASH (Metabolic dysfunction-Associated SteatoHepatitis), targeting progressive fibrosis in F2/F3 MASH patients[1,5] - The company anticipates regulatory filings in 2027 and a potential commercial launch in 2028, pending approval[8] - Phase 2b trial data showed a 24% effect size on the dual endpoint of fibrosis improvement and MASH resolution in just 24 weeks[70] - The Phase 3 NATiV3 clinical trial is fully recruited with 1,009 patients in the main cohort and 410 in the exploratory cohort[56] - Topline data from the Phase 3 trial is expected in the second half of 2026[8,64] MASH Market and Medical Understanding - The MASH market is expected to exceed $15 billion by 2035[15] - Approximately 19 million were diagnosed with MASH in the U S in 2025, representing ~10% of the patients with MASH[13] - Approximately 910,000 patients have clinically actionable F2/F3 disease, with about 374,000 (~40%) under treated care[14] Financial Position - The company raised $172 million from investors in November 2025[8] - The company's cash runway extends until the middle of Q3 2027, assuming full exercise of the 3rd tranche[8,67]

Summary of Madrigal Pharmaceuticals FY Conference Call Company Overview - **Company**: Madrigal Pharmaceuticals (NasdaqGS:MDGL) - **Industry**: Metabolic and liver disease - **Key Product**: Rezdiffra, the first-ever approved product for MASH (Metabolic Associated Steatotic Hepatitis) Core Points and Arguments 1. **Market Leadership**: Madrigal is positioned as a leader in the MASH space with a successful product launch, achieving over $1 billion in annualized sales after six quarters [3][4][29]. 2. **Future Growth**: The company anticipates significant growth opportunities with the upcoming F4C indication data expected in 2027, which could potentially double the market opportunity for Rezdiffra [4][30]. 3. **Patient Base**: As of Q3 2025, over 29,500 patients are on Rezdiffra therapy, with 10,000 prescribers, indicating a strong foundation for continued growth [9][10]. 4. **Market Dynamics**: The MASH market is currently under-penetrated, with only 10% of diagnosed patients being treated. The company sees potential for expansion similar to other large specialty markets [11][12]. 5. **Pipeline Development**: Madrigal is focused on building a robust pipeline in MASH, including new mechanisms of action and combination therapies to enhance treatment efficacy [17][18][20]. Important Developments 1. **Combination Therapies**: The company is exploring combination therapies with new assets like a DGAT2 inhibitor and an oral GLP-1 molecule, which are expected to enhance the efficacy of Rezdiffra [20][25]. 2. **Clinical Trials**: Ongoing and upcoming trials include the Maestro Outcomes trial for F4C and the Maestro NASH study for F2, F3, with data expected in 2027 and 2028 respectively [17][18]. 3. **Market Access**: Madrigal has secured first-line access with no step-edit requirements, which is crucial for maintaining strong market presence against competitors [10][49]. Financial Outlook 1. **Sales Growth**: The company expects robust net revenue growth in 2026 despite anticipated changes in gross-to-net dynamics due to commercial contracting [49][50]. 2. **Profitability Timeline**: While profitability is not the immediate focus, the company is confident in achieving it as top-line growth outpaces spending [45][46]. Additional Insights 1. **Global Expansion**: Madrigal has launched in Germany and is exploring opportunities in other countries, particularly in the Middle East, but does not expect significant contributions from international sales in 2026 [55][56]. 2. **Competitive Landscape**: The company acknowledges the presence of competitors but believes that the unique profile of Rezdiffra and its established market access will allow it to thrive [10][53]. Conclusion Madrigal Pharmaceuticals is strategically positioned to lead the MASH market with its innovative product Rezdiffra and a growing pipeline. The company is focused on maximizing its market potential through combination therapies and expanding its patient base while maintaining a strong financial outlook for the coming years [28][30].

Summary of Sagimet Biosciences FY Conference Call Company Overview - **Company**: Sagimet Biosciences (NasdaqGM:SGMT) - **Focus**: Development of novel therapeutics targeting fatty acid synthesis for diseases such as MASH (Metabolic Dysfunction-Associated Steatotic Liver Disease) and acne [1][2] Key Points on MASH Program - **Lead Molecule**: Denifenstat, a potent FASN (fatty acid synthase) inhibitor, is being developed for MASH and acne [2][3] - **Mechanism of Action**: Denifenstat targets fat, inflammation, and fibrosis, differentiating it from other treatments that primarily focus on fat oxidation or mobilization [3][10] - **Clinical Data**: - Phase IIB study showed a 30% placebo-adjusted improvement in fibrosis [10] - In F4 patients, 11 out of 13 showed a one or two-stage improvement in fibrosis [6][4] - **Combination Therapy**: A combination program with resmetirom is underway, showing enhanced effects on inflammation and fibrosis [6][18] - **Funding Needs**: Approximately $400 million is required to complete the Phase III study for the F2 and F3 populations, with current cash reserves at $125 million [16][30] Key Points on Acne Program - **Partnership**: Collaboration with Ascletis in China for acne studies, showing 20% placebo-adjusted improvements in lesion reduction [8][23] - **Regulatory Pathway**: Plans to seek FDA guidance in early 2026 regarding the use of Ascletis' Phase III data for U.S. regulatory approval [24][25] - **Next-Gen Molecule**: Development of TVB-3567, a more potent follow-on oral FASN product, is in Phase I [25][26] - **Market Potential**: The acne market is significant, with an estimated 50 million Americans affected, and the introduction of effective treatments is expected to increase patient demand [23][24] Financial Considerations - **Royalty Stream**: Expected inflow of approximately $120 million from milestones and royalties related to the acne program in China [29] - **Capitalization Requirements**: The company acknowledges the need for substantial funding to support ongoing and future clinical programs [30] Additional Insights - **Unique Positioning**: Denifenstat is the only FASN inhibitor in development, which is a significant differentiator in the market [11][12] - **Long-Term Strategy**: The company recognizes the necessity for combination therapies in treating patients effectively, indicating a strategic approach to drug development [20][21] - **Intellectual Property**: New IP filed for the combination therapy is expected to provide protection until 2044 [22] This summary encapsulates the critical insights from the Sagimet Biosciences FY conference call, highlighting the company's strategic direction, clinical advancements, and financial outlook.

Financial Data and Key Metrics Changes - The company reported a 15% top-line growth year-to-date and an 11% growth for the quarter, indicating strong momentum in its financial performance [5][21] - The guidance for top-line growth for 2025 has been narrowed to a range of 8%-11%, with corresponding adjustments to operating profit growth [21] Business Line Data and Key Metrics Changes - The diabetes segment experienced a 10% growth, while obesity care saw a remarkable 41% growth, with 83% of this growth coming from international operations (IO) and 24% from the U.S. [11] - Rare disease products returned to normal production levels, growing 13% in a balanced manner between IO and the U.S. [11] Market Data and Key Metrics Changes - The U.S. market for anti-obesity medications continues to expand, with a significant increase in out-of-pocket expenses for patients, rising from 4% to over 10% in just nine months [12] - The company is currently addressing only 3-4 million patients in the obesity market, compared to an estimated 100 million potential patients [12] Company Strategy and Development Direction - The company is sharpening its strategy to focus on treating patients with obesity and diabetes, emphasizing the overlap of these conditions with other comorbidities [8][10] - The acquisition of Akero is part of the strategy to deepen its focus on metabolic diseases, particularly MASH (Metabolic Dysfunction-Associated Steatotic Liver Disease) [9][10] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the growth potential in the obesity market, highlighting the significant unmet needs and the company's commitment to expanding its product portfolio [9][14] - The company is preparing for the launch of oral semaglutide, which is expected to capture a significant portion of the market due to its unique profile [96][97] Other Important Information - The company is facing regulatory challenges regarding the Metsera acquisition, but remains confident in the quality of the portfolio and its potential [59][68] - There are ongoing discussions about the competitive landscape in the U.S. for GLP-1 products, with management noting a slight decline in Ozempic scripts but a belief in continued growth potential outside the U.S. [82][84] Q&A Session Summary Question: What do you expect to learn from the amycretin trials? - Management indicated that they will not progress to phase III trials without clear differentiation in efficacy, safety, or scalability [25] Question: Can you explain the recent pricing trends for GLP-1 products? - Management confirmed that pricing for Ozempic is expected to decline by 10%-15% year-on-year, while Wegovy's pricing has also seen a decrease [27][28] Question: How are you addressing the consumerization of the sales force? - The company is focusing on understanding patient needs and behaviors, emphasizing the importance of direct purchasing channels and expanding product offerings [31][36] Question: What is the outlook for revenue growth in 2026? - Management refrained from providing specific guidance for 2026 but highlighted the potential of the Wegovy pill launch and ongoing pipeline developments as future growth drivers [49][51] Question: What if the FTC blocks the Metsera acquisition? - Management expressed confidence in the acquisition's merits and readiness to discuss its benefits with the FTC [56][59] Question: Are there any supply limitations for the oral semaglutide? - Management reassured that there are no anticipated supply limitations for the oral semaglutide launch [101]