Revenue Expectations - Preliminary revenue for Q4 2025 is expected to be approximately $411 million, representing a 12% growth on a reported basis and 11% growth on a constant currency basis[7]. - Preliminary full-year revenue for 2025 is expected to be approximately $1,523 million, reflecting a 9% growth on both a reported and constant currency basis[7]. Earnings Projections - Non-GAAP earnings per diluted share for Q4 2025 are expected to exceed $1.54, while for the full year 2025, it is expected to exceed $5.55[7]. Shipments and Production - Shipments of noninvasive technology boards and instruments are expected to be approximately 69 thousand for Q4 2025 and 270 thousand for the full year 2025[7]. Business Performance and Strategy - The company achieved a record level of incremental contract value from new customers and expanded hospital agreements in 2025, positioning for sustained performance[2]. - Financial guidance includes the impact of one additional calendar week, which is expected to contribute to revenue but is offset by revenue lost from discontinued product lines and a shift to a distributor model in some markets[4]. - The company is facing uncertainties related to new tariffs, which could materially affect actual results compared to projections[4]. Financial Reporting and Measures - Non-GAAP financial measures are used internally for operating and budgeting purposes and are believed to assist investors in comparing period-to-period operating results[6]. - The company has revised its definition of litigation-related expenses to exclude all Apple litigation expenses, aiming to provide clearer financial performance comparisons[17]. Future Guidance - Management plans to discuss complete Q4 results and full-year 2026 guidance after the market closes on February 26, 2026[3]. Technology and Market Position - Masimo develops and produces a wide array of industry-leading monitoring technologies, including innovative measurements, sensors, and patient monitors[31]. - Masimo SET pulse oximetry is estimated to be used on more than 200 million patients globally each year[31]. - Masimo SET has been shown to outperform other pulse oximetry technologies in over 100 independent studies[31]. - Masimo's technologies are the primary pulse oximetry used in all 10 top U.S. hospitals as ranked in the 2025 Newsweek World's Best Hospitals listing[31].

Patient Population and Market Potential - Claseprubart has a target patient population of over 100,000 in the U.S. for generalized myasthenia gravis (gMG), with approximately 85% of these patients having AChR autoantibody-driven disease[4] - The U.S. market for gMG biologics is currently valued at over $3.5 billion, with less than 20% of AChR+ patients treated with biologics, indicating significant growth potential[11] - The company anticipates that self-administered treatments will grow substantially, with expectations for the segment to increase from a small part of the market to approximately 50% in the next three years[10] - The US CIDP market presents a substantial growth opportunity, with current treatments exceeding $3.5 billion and a significant percentage of patients remaining refractory[37] - The US MMN market is projected to grow at ~11% per year, with an opportunity for claseprubart to become the new standard of care[43] - The MMN market has over 10,000 patients in the U.S., with no approved targeted biologic therapies currently available[60] Clinical Trial Results and Efficacy - Claseprubart's Phase 2 trial results demonstrated rapid and sustained symptom improvements, supporting its potential as a best-in-class treatment for gMG[14] - The Phase 2 trial for Claseprubart enrolled 65 participants, exceeding the target enrollment, indicating strong interest and potential for the treatment[15] - Statistically significant improvement in MG-ADL score for both claseprubart arms vs. placebo at Week 13, with mean changes of -1.8 for 300mg/2mL and -2.6 for 600mg/4mL[17] - 60% of participants on claseprubart 300mg/2mL achieved a ≥5 point improvement in MG-ADL at Week 13[21] - Statistically significant improvement in QMG score for both claseprubart arms vs. placebo at Week 13, with mean changes of -2.4 for 300mg/2mL and -2.5 for 600mg/4mL[18] - 37% of 300mg/2mL claseprubart-treated participants achieved Minimal Symptom Expression on MG-ADL at Week 13[23] - Statistically significant improvement in MGC score for both claseprubart arms vs. placebo at Week 13, with mean changes of -5.5 for 300mg/2mL and -5.6 for 600mg/4mL[24] - Statistically significant improvement in MG-QoL-15r score for 300mg/2mL vs. placebo at Week 13, with a mean change of -2.2[25] - Claseprubart demonstrated robust and clinically meaningful responses across key efficacy measures, achieving statistical significance vs. placebo across all five key efficacy measures for the 300mg/2mL treatment arm[26] - Claseprubart demonstrated robust reductions in MG-ADL and QMG scores, with a mean change of -3.0 in MG-ADL from baseline in patients receiving the treatment[32] Safety and Tolerability - Claseprubart was generally well tolerated, with a comparable clinical safety profile to placebo and no significant adverse events reported[29] - The proportion of participants achieving MG-ADL score of 0 or 1 was 14% for placebo, 37% for 300mg/2mL, and 23% for 600mg/4mL[26] - In Phase 1 trials, Claseprubart was generally well tolerated with no serious adverse events reported, and only mild/moderate treatment-related adverse events were observed[73] Dosing and Administration - The company is targeting a dosing regimen of 300mg/2mL every two weeks for Claseprubart, which supports convenient, infrequent self-administration[14] - Claseprubart's target profile aims for a patient-friendly administration with a single 300mg/2mL subcutaneous dose every two weeks, potentially replacing the current standard of care[38] - Claseprubart is designed for Q2W self-administration via a 300mg/2mL subcutaneous autoinjector, enhancing patient convenience[46] - The rationale for Q4W 300mg/2mL dosing is based on potential for enhanced, best-in-class efficacy in generalized Myasthenia Gravis (gMG)[30] Future Trials and Development - Claseprubart is expected to initiate its Phase 3 trial for gMG in 2026, with interim responder analysis planned for Q2 2026 and top-line results for Phase 2 MMN expected in the second half of 2026[3] - The Phase 3 trial design includes a new screening criterion of QMG >10 and MG-ADL >6, aiming to enhance efficacy and dosing convenience[34] - Interim responder analysis for the CIDP pivotal trial is expected to include the first 40 patients by Q2 2026, with a focus on a 52-week placebo-controlled study[40] - The Phase 2 trial for claseprubart in MMN is ongoing, with top-line data expected in the second half of 2026[48] Financial Position - The company has a strong financial position with approximately $514 million in cash, providing a runway into 2028 to fund multiple near-term catalysts[3] - The company has a strong balance sheet with approximately $514 million in cash, providing a runway into 2028[60] Mechanism of Action - The dual mechanism of action of Claseprubart targets both innate and adaptive immune systems, demonstrating superior in vitro efficacy compared to existing treatments[4] - Claseprubart selectively inhibits the classical pathway of the complement system, preserving alternative and lectin pathways, which may lower the risk of infections compared to downstream inhibitors[65] - In vitro studies indicate that Claseprubart maintains bacterial killing against Neisseria meningitidis, suggesting a differentiated safety profile compared to C5 inhibitors[65] - Claseprubart demonstrated superior classical pathway potency with an IC50 of 3.8 ± 0.8 µg/mL, approximately 6 times more potent than empasiprubart at 22.1 ± 5.7 µg/mL[45] - Claseprubart has shown superior affinity and potency compared to riliprubart, with an approximately 8X improvement in blocking the complement cascade[39] Intellectual Property - The expected expiration of the composition of matter patent for DNTH212 is no earlier than 2044, ensuring robust intellectual property protection[58]

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]