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]

Financial Performance & Outlook - PTC achieved total revenue of $807 million in 2024[14] - PTC has a strong cash position of over $2 billion, enabling future revenue growth and R&D innovation[15] - PTC aims to reach cash flow break-even without additional capital[16] - PTC's vision includes a path to $2 billion in topline revenue[53] Key Product Programs & Milestones - Four U S regulatory approval applications were submitted in 2024[11] - AADC Gene Therapy BLA was approved[12] - Sephience (sepiapterin) in PKU has a potential revenue opportunity greater than $1 billion[28] - Vatiquinone for Friedreich's Ataxia (FA) has an NDA filing accepted with Priority Review, with an approval decision expected August 19, 2025[32] - PTC518 for Huntington's Disease (HD) has a development and commercialization collaboration with Novartis, including $1 billion upfront payment and up to $19 billion in milestones[45] Research & Development - PTC has innovative research platforms, including a validated splicing platform[48] - PTC has inflammation & ferroptosis programs targeting CNS and non-CNS disorders[50]

Core Insights - Chemomab Therapeutics has achieved significant milestones in the development of nebokitug for the treatment of primary sclerosing cholangitis (PSC), including a clear regulatory pathway with the FDA for potential full approval and positive 48-week data from the Phase 2 SPRING trial [1][2][10] Company Developments - The company reported that nebokitug treatment in PSC patients with moderate/advanced disease resulted in continued improvements across key biomarkers of liver injury, inflammation, and fibrosis [1][2] - Chemomab has aligned with the FDA on a streamlined regulatory approval program for nebokitug, which will utilize a single pivotal Phase 3 trial based on clinical events associated with disease progression, eliminating the need for liver biopsies [2][10] - The positive results from the SPRING trial indicate that nebokitug-treated patients showed a significantly lower number of clinical events compared to historical controls, particularly in the 20 mg/kg dose group [2][4] Financial Highlights - As of March 31, 2025, Chemomab's cash position was $10.6 million, down from $14.3 million at the end of 2024, with a cash runway expected to last until the second quarter of 2026 [5][8] - The company reported a net loss of $3.3 million for the first quarter of 2025, compared to a net loss of $3.9 million in the same period of 2024 [8][14] Research and Development - R&D expenses for the first quarter of 2025 were $2.5 million, a decrease from $3.1 million in the first quarter of 2024, primarily due to the winding down of activities related to the Phase 2 SPRING trial [8][13] - The company is actively pursuing multiple partnering options to advance the nebokitug program and is in discussions with potential strategic partners [1][2] Clinical Trial Updates - Data from the Phase 2 SPRING trial was presented at major conferences, including Digestive Disease Week 2025 and EASL 2025, highlighting the drug's potential in treating PSC [3][4] - The Open Label Extension study confirmed that nebokitug was safe and well-tolerated over 12 months, with significant improvements in liver biomarkers and stabilization of cholestasis-related markers [6][10]

Financial Data and Key Metrics Changes - Earnings per share for Q1 2025 were $1.05, an increase of nearly 11% compared to $0.95 in Q1 2024 [7] - Consolidated reported earnings were $1.5 per share, up $0.10 per share versus the same period in 2024 [13] - Revenues increased by $0.44 per share, primarily due to authorized rate increases and organic customer growth [13] Business Line Data and Key Metrics Changes - Operating costs increased by $0.15 per share, driven by employee-related costs and acquisitions [14] - Depreciation increased by $0.11 per share and financing costs increased by $0.10 per share, both as expected to support investment growth [14] Market Data and Key Metrics Changes - The company achieved an annualized revenue increase of $63 million in Missouri, with new rates expected to take effect on May 31, 2025 [15] - In Virginia, an annualized increase of $15 million in water and wastewater revenues was approved [16] Company Strategy and Development Direction - The company affirmed long-term targets for earnings and dividend growth at 7% to 9%, driven by 8% to 9% rate base growth [10] - The Board approved an increase in the quarterly cash dividend from $0.765 to $0.825, an 8.2% increase [11] - The company is focused on infrastructure investments and acquisitions to support growth, with a capital investment goal of approximately $3.3 billion in 2025 [23] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving 2025 EPS guidance, representing 8% annual growth [20] - The company noted that recent tariff-related announcements are not expected to materially impact 2025 plans or financial results [21] - The management highlighted the need for significant investments in U.S. water infrastructure, estimating a total need of $625 billion over the next twenty years [30] Other Important Information - The company is well-positioned for growth through acquisitions, with about 37,000 customer connections under agreement [28] - The American Society of Civil Engineers rated the nation's drinking water systems a C- and wastewater systems a D+, indicating a dire need for infrastructure investment [30] Q&A Session Summary Question: Thoughts on pulling forward 2026 equity issuance - The company has no plans to pull forward equity issuance and will issue equity when needed [39] Question: Acquisition outlook under potential recession - The company expects a continuous flow of acquisition opportunities, potentially driven by recession or reduced federal funding [40] Question: Update on California desalination project - The company expects to break ground on the desalination project this year, which is separate from the rate case [52] Question: Legislative progress and opportunities - The company has not quantified the opportunities from legislative changes but noted they will help earned returns [61]

Table of Contents As filed with the Securities and Exchange Commission on January 23, 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 AARDVARK THERAPEUTICS, INC. (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporation or organization) 4370 La Jolla Village Drive, Suite 1050 San Diego, CA 92122 (858) 225-7696 (Address, including zip code, and telepho ...

As filed with the Securities and Exchange Commission on June 24, 2024 Registration No. 333-277066 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Amendment No. 3 to FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 Onconetix, Inc. (Exact Name of Registrant as Specified in its Charter) (State or other jurisdiction of incorporation or organization) Delaware 2834 83-2262816 (Primary Standard Industrial Classification Code Number) (I.R.S. Employer Identification No.) 201 E ...

As filed with the Securities and Exchange Commission on June 14, 2024. Registration No. 333-279121 UNITED STATES SECURITIES AND EXCHANGE COMMISSION AMENDMENT NO. 1 to FORM S-1 Washington, D.C. 20549 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 SERINA THERAPEUTICS, INC. (Exact Name of Registrant as Specified in our Charter) Delaware 2834 82-1436829 (State or Other Jurisdiction of Incorporation or Organization) (Primary Standard Industrial Classification Code Number) (I.R.S. Employer Identification ...

As filed with the Securities and Exchange Commission on June 4, 2024 Registration No. 333-277066 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Amendment No. 2 to FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 Onconetix, Inc. (Exact Name of Registrant as Specified in its Charter) (State or other jurisdiction of incorporation or organization) Delaware 2834 83-2262816 (Primary Standard Industrial Classification Code Number) (I.R.S. Employer Identification No.) 201 E. ...

As filed with the Securities and Exchange Commission on April 1, 2024. Table of Contents Registration No. 333-278003 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Amendment No. 1 to FORM S-1 REGISTRATION STATEMENT Under The Securities Act of 1933 CONTINEUM THERAPEUTICS, INC. (Exact name of Registrant as specified in its charter) (State or other jurisdiction of incorporation or organization) Delaware 2834 27-1467257 (Primary Standard Industrial Classification Code Number) (I.R.S. Em ...

Table of Contents As filed with the Securities and Exchange Commission on March 15, 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 CONTINEUM THERAPEUTICS, INC. (Exact name of Registrant as specified in its charter) (State or other jurisdiction of incorporation or organization) Delaware 2834 27-1467257 (Primary Standard Industrial Classification Code Number) (I.R.S. Employer Identification Nu ...