Revenue Guidance - Jazz Pharmaceuticals expects to meet its previously announced total revenue guidance range for the year ended December 31, 2025[4] - The company will provide specific revenue expectations for its products Xywav, Epidiolex, and Modeyso for the year ended December 31, 2025[4] Corporate Events - The corporate overview and financial update will be presented at the J.P. Morgan Healthcare Conference on January 13, 2026[4]

Washington, D.C. 20549 FORM 8-K _______________________________ CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Date of Report (Date of earliest event reported): January 12, 2026 CARIS LIFE SCIENCES, INC. (Exact name of registrant as specified in its charter) | Texas | 001-42706 85-2077369 | | --- | --- | | (State or other jurisdiction of | (Commission (IRS Employer | | incorporation) | File Number) Identification No.) | ...

Financial Results Announcement - Norwood Financial Corp will release its fourth quarter 2025 financial results on January 22, 2026[6] - A webcast and conference call will be held on the same day to discuss the financial results[6] - The press release announcing the financial results is included as exhibit 99.1[6]

Financial Results - Elutia Inc. announced preliminary results for Q4 2025, with results subject to year-end accounting and audit procedures[4] - The press release detailing the financial results was issued on January 12, 2026[4] Company Information - The company is listed on The Nasdaq Capital Market under the trading symbol ELUT[2]

Financial Results Announcement - Elutia Inc. announced preliminary results for Q4 2025, subject to year-end accounting and audit procedures[4] - The press release detailing these results was issued on January 12, 2026[4] Financial Statements - The financial statements and exhibits related to the report are included as Exhibit 99.1 and Exhibit 104 respectively[7]

Financial Results - Soleno Therapeutics, Inc. announced preliminary financial results for Q4 and the full year ended December 31, 2025[4] - The press release detailing these results was issued on January 12, 2026[4] Company Information - The company is listed on NASDAQ under the ticker symbol SLNO[2]

Collaboration and Financials - FHD-909 is being developed in collaboration with Lilly, with a significant agreement signed in December 2021, including $300 million cash and $80 million in common stock[9] - The collaboration includes a 50/50 U.S. economic split on the SMARCA2-target program and potential royalties ranging from low double-digit to 20s[9] - The collaboration with Lilly is expected to yield up to $1.3 billion in potential milestones across three programs[9] - Foghorn's cash position is $158.9 million, providing a runway into 2028, with a potential market impact on approximately 2.5 million patients[48] Clinical Development and Pipeline - FHD-909 is currently in Phase 1 clinical trials, targeting SMARCA4-mutant cancers, which account for approximately 10% of NSCLC and up to 5% of all solid tumors[12][14] - FHD-909 aims to become a first-line treatment for SMARCA4-mutant NSCLC, addressing significant unmet medical needs in this patient population[15][16] - The company is advancing multiple preclinical assets towards INDs, including selective inhibitors for SMARCA2, CBP, EP300, and ARID1B[10] - The selective SMARCA2 inhibitor FHD-909 is partnered with Lilly, with a $380 million upfront payment and is currently in Phase 1 trials[48] Efficacy and Mechanism of Action - The overall response rate (ORR) for patients with SMARCA4 mutations is significantly lower compared to those without, highlighting the urgent need for targeted therapies[17] - FHD-909 leverages a synthetic lethal relationship between SMARCA2 and mutated SMARCA4, representing a promising strategy in precision medicine[12][13] - FHD-909 demonstrated significant tumor regression in SMARCA4-mutant NSCLC models at tolerated doses, with a maximum dose of 60 mg/kg[52] - In vivo studies show that combining FHD-909 with cisplatin and pemetrexed enhances antitumor effects, resulting in significant tumor regression[54] - FHD-909 exhibits synergistic activity when combined with KRAS inhibitors in vitro, indicating potential for enhanced therapeutic efficacy[56] - FHD-909 sensitized tumor cells to pembrolizumab, resulting in enhanced anti-tumor activity, with pembrolizumab alone showing no effect compared to vehicle control[59] - Combination of FHD-909 with olomorasib demonstrated synergistic antitumor activity with a significant p-value of <0.05 in NCI-H2030 models[57] - FHD-909 combined with pan-KRAS inhibitor resulted in sustained tumor regression, also showing a significant p-value of <0.05 for the combination group[58] Preclinical Assets and Future Developments - The selective CBP degrader, FHT-171, is IND-ready in 2026, with a focus on CBP-dependent and EP300-mutant cancers, showing increased tolerability compared to non-selective compounds[24] - IND-enabling studies for selective EP300 degraders are planned for 2026, focusing on improved tolerability and deeper efficacy responses compared to non-selective molecules[32] - The selective EP300 degrader EP300d-007 shows superior efficacy in IMiD resistant multiple myeloma models, achieving deeper responses compared to pomalidomide and inobrodib[38] - The ARID1A mutation incidence in endometrial cancers is approximately 66,000 per year in the U.S., with ARID1B being a major synthetic lethal target[41] - The ARID1B degrader treatment has shown effects on downstream target genes, progressing towards in vivo proof-of-concept[47] - The company is advancing multiple preclinical assets towards INDs, including selective degraders for ARID1B and EP300[48] Safety and Tolerability - No significant impact on platelet counts was observed following treatment with selective CBP and EP300 degraders, indicating a favorable safety profile[35] - The long-acting injectable formulation of CBPd-171 enables weekly subcutaneous delivery, showing comparable efficacy to daily injections in gastric cancer models[30] Degradation Mechanisms - Selective degradation of CBP leads to reduced expression of estrogen receptor target genes, resulting in cancer cell growth inhibition[25] - The selective EP300 degrader shows anti-proliferative activity across a broad range of hematological malignancies, with approximately 70% of tested cell lines being sensitive[33] - EP300 degradation results in significant tumor growth inhibition in multiple myeloma and DLBCL models, with fold selectivity exceeding 1000x for certain compounds[34] - Experimental kinetic analysis indicates that degradation rates are crucial for determining the efficiency of protein degraders, with slower rates leading to partial degradation[62] - Prelude's SMARCA2 (VHL) degrader achieved improved degradation metrics compared to SMARCA2 (CRBN) degrader, indicating faster action at high concentrations[64] - Foghorn's analysis of degradation rates aligns with published data, confirming the efficacy of their degraders in achieving significant protein degradation[65]

Financial Results - Inogen, Inc. reported preliminary, unaudited revenue results for Q4 and full year 2025, with specific figures to be confirmed upon completion of audited financial statements[6] - The financial position and results of operations as of December 31, 2025, are subject to change, highlighting the need for further disclosures[6] Press Release - The press release detailing these results was issued on January 12, 2026, indicating the company's ongoing financial disclosures[6]

Financial Projections - Expected net product sales for 2026 are projected to be between $630 million and $650 million, with a compound annual growth rate (CAGR) of 91% from 2022 to 2025[3]. - The company expects FY 2026 net product sales guidance to be between $630 million and $650 million, with cash flow positive anticipated in 2027[39]. - The company has a cash balance of $392 million as of December 31, 2025, which is preliminary and subject to financial closing procedures[39]. Product Development and Pipeline - The peak revenue potential of Mirum's portfolio, including the proposed acquisition of Bluejay Therapeutics, is estimated to exceed $4 billion within the next 18 months[3]. - The ongoing EXPAND Phase 3 study for LIVMARLI® is expected to provide topline data by Q4 2026, targeting cholestatic liver disease patients[16]. - Volixibat, another product candidate, is undergoing a Phase 2b study for Primary Sclerosing Cholangitis (PSC) patients, with confirmatory topline data expected in Q2 2026[19]. - Four potentially registrational topline readouts are expected in the next 18 months, including VANTAGE (PBC) and VISTAS (PSC) results[39]. - The VANTAGE study for PBC patients with moderate-to-severe pruritus has completed enrollment and topline results are expected in H1 2026[25][39]. - Ongoing Phase 3 trials for Brelovitug are supporting FDA and EMA filings, with topline data expected in H2 2026[37]. - The Phase 2 study of MRM-3379 for Fragile X Syndrome is expected to provide topline data in 2027[33]. Market Expansion and Strategic Focus - The company aims to expand its international market presence and maintain intellectual property protection until at least 2040[9]. - The proposed acquisition of Bluejay Therapeutics is anticipated to close in January 2026, subject to customary conditions, which may enhance Mirum's operational capabilities[3]. - Mirum's strategic focus on rare diseases positions it as a leader in the global market, with significant commercial synergies anticipated from its bile acid portfolio[12]. - The company is actively pursuing market expansion and new product development strategies to enhance its portfolio and address unmet medical needs[45]. Product Performance and Safety - LIVMARLI® has shown significant year-over-year growth, with projected annual net product sales of $359 million for 2025, reflecting a 69% increase from 2024[8]. - LIVMARLI total net product sales for FY 2024 reached $336.4 million, with Q4 2024 sales projected at $99.4 million[45]. - LIVMARLI's US sales for Q1 2025 are estimated to be $49.5 million, increasing to $74 million by Q4 2025[45]. - 84% of patients treated with LIVMARLI experienced a clinically meaningful improvement in cholestatic pruritus, with 83% achieving a ≥20% reduction in serum bile acid (sBA) levels[48]. - In a post-hoc analysis, 93% of patients with a >1-point reduction in ItchRO[Obs] remained transplant-free six years after starting LIVMARLI[49]. - 62% of PFIC patients treated with LIVMARLI reported minimal to no itch after 26 weeks of treatment, compared to 28% in the placebo group[50]. - Significant reductions in serum bile acids were observed, with a mean decrease of 160 µmol/L in LIVMARLI patients compared to placebo[52]. - LIVMARLI has a well-characterized safety profile, with the most common adverse events being diarrhea and abdominal pain, occurring at rates of 41.6 and 38.6 events per 100 person-years, respectively[54]. Intellectual Property and Regulatory Designations - The company has intellectual property coverage for LIVMARLI in the United States extending to 2040, including multiple patents related to dosing and formulation[57]. - The company has multiple patents listed in the Orange Book, with key patents expiring between 2027 and 2043, indicating a strong pipeline for future treatments[60]. - The company has received orphan designation for its PBC indication, granting 10 years of market exclusivity from approval[60]. - The method of treatment for dosing is pending approval for several indications, showcasing ongoing innovation in the company's product offerings[60]. - The company has granted FDA Breakthrough Therapy Designation for Volixibat, which is expected to launch in H1 2026[25][39].

Financial Position - As of December 31, 2025, the preliminary unaudited cash, cash equivalents, and marketable securities of Disc Medicine, Inc. were approximately $791 million[6] - The estimate of cash and marketable securities is preliminary and subject to change upon completion of the year-end financial close process[7] - The independent registered public accounting firm has not audited or reviewed the preliminary results, indicating no assurance on the figures provided[7] - The company has no intention or obligation to update the preliminary estimate of its cash and marketable securities[7] - Additional information will be required for a complete understanding of the company's financial position and results of operations as of December 31, 2025[7] Business Objectives and Events - The company announced its recent achievements and key business objectives for 2026 on January 12, 2026[9] - Disc Medicine, Inc. will participate in the 44th Annual J.P. Morgan Healthcare Conference starting January 12, 2026, with a presentation scheduled for January 14, 2026[10] - The press release detailing the financial results and business objectives is attached as Exhibit 99.1[9] - The presentation materials for the conference are attached as Exhibit 99.2[10] Company Classification - The company is classified as an emerging growth company under the Securities Act[5]