Financial Projections - Preliminary unaudited total revenue for full year 2025 is expected to be approximately $145 million, with U.S. XPOVIO net product revenue estimated at $115 million[1][4][8]. - Cash and cash equivalents as of December 31, 2025, were approximately $64 million, expected to fund operations into Q2 2026[8]. - The company is currently evaluating its preliminary financial information for Q4 and full year 2025, including expected cash runway and liquidity[28]. Clinical Trials and Research - The Phase 3 SENTRY trial in myelofibrosis completed enrollment with 353 patients, evaluating selinexor in combination with ruxolitinib[3][13]. - Top-line data from the Phase 3 SENTRY trial is expected in March 2026, which could redefine the standard-of-care in myelofibrosis[2][14]. - The Phase 3 XPORT-EC-042 trial in endometrial cancer is on track to report top-line data in mid-2026, focusing on a targeted patient population[2][10]. - The company modified the design of the Phase 3 XPORT-EC-042 trial to focus on patients with proficient and deficient mismatch repair status, increasing the sample size to approximately 276 patients[8][18]. Product and Market Development - Demand for XPOVIO remained consistent in 2025 compared to 2024, with approximately 60% of overall net product revenue driven by the community setting[4]. - Global patient access for selinexor expanded in 2025, with approvals in over 50 countries, including favorable reimbursement decisions in Spain and China[4]. - Karyopharm Therapeutics' lead compound, XPOVIO® (selinexor), is approved in the U.S. and marketed in three oncology indications, with regulatory approvals in over 50 territories including the EU and China[27]. Safety and Adverse Reactions - In the BOSTON trial, 6% of patients experienced fatal adverse reactions within 30 days of the last treatment, while serious adverse reactions occurred in 52% of patients[26]. - The treatment discontinuation rate due to adverse reactions in the BOSTON trial was 19%[26]. - In the STORM trial, 9% of patients experienced fatal adverse reactions, with serious adverse reactions occurring in 58% of patients[26]. - The discontinuation rate due to adverse reactions in the STORM trial was 27%[26]. - In the SADAL trial, fatal adverse reactions occurred in 3.7% of patients within 30 days and 5% within 60 days, with serious adverse reactions occurring in 46% of patients[26]. Strategic Outlook - Karyopharm anticipates 2026 to be a catalyst-rich year with significant opportunities for long-term value creation[2]. - The company completed strategic financing transactions to extend cash runway beyond the expected top-line readout of the Phase 3 SENTRY trial[8]. - Management emphasizes the importance of regulatory approvals and successful commercialization of XPOVIO and other drug candidates[29]. - Karyopharm is focused on developing therapies for multiple high unmet need cancers, including multiple myeloma and diffuse large B-cell lymphoma (DLBCL)[27]. Risks and Uncertainties - Karyopharm's forward-looking statements are subject to numerous risks and uncertainties that may cause actual results to differ materially from current expectations[28].

Financial Position - Cash runway expected to extend into Q1 2027 based on cash, cash equivalents, and marketable securities as of December 31, 2025[3] - As of December 31, 2025, the company reported a cash balance of approximately $46 million, providing a runway into the first quarter of 2027[31] Clinical Development - PBFT02 shows promising data from initial clinical study in FTD-GRN, with a one-time gene replacement therapy approach[4] - The ongoing upliFT-D trial is a global Phase 1/2 study currently enrolling patients, focusing on safety and biomarkers[13] - PBFT02's differentiated gene therapy approach is expected to address the urgent patient need in FTD-GRN with no approved disease-modifying therapies[4] - PBFT02 aims to provide a one-time therapy capable of achieving the highest progranulin levels, addressing underlying pathologies in frontotemporal dementia (FTD) and amyotrophic lateral sclerosis (ALS)[20] - The company plans to initiate discussions with the FDA regarding a registrational study design for FTD-GRN in the first half of 2026[30] - The company expects to declare a clinical candidate for Huntington's disease in the second half of 2026[27] Efficacy and Safety - PBFT02 administration in preclinical studies resulted in CSF hPGRN levels 5x higher than AAVhu68, indicating superior response[10] - PBFT02 demonstrated robust, durable increases in CSF PGRN levels, with a patient increasing from 1.5 ng/mL at baseline to 7.6 ng/mL at month 1[16] - Plasma NfL in PBFT02-treated patients showed a reduced annual rate of change of 3.7% compared to published natural history data of ~29%[17] - PBFT02 demonstrated a generally well-tolerated safety profile with no serious adverse events (SAEs) related to Dose 2, while two SAEs occurred at Dose 1[18] - The mean cerebrospinal fluid (CSF) PGRN level at 12 months was 26 ng/mL, with a durable elevation observed at 18 months in some patients[19] Manufacturing and Production - The company has completed a high-productivity manufacturing process, with a single production lot estimated to yield over 1,000 doses with over 70% full capsids[29] - The company has aligned with the FDA on an analytical approach to establish comparability of the suspension-based manufacturing process for PBFT02[29] Market Context - Estimated prevalence of neurodegenerative diseases includes ~70K for FTD-GRN, ~21K for FTD-C9orf72, and ~18K for Huntington's disease in the US and EU[5] - Key baseline demographics for FTD-GRN participants indicate a mean age of 64.4 years and a mean PGRN level of 36.6 ng/mL in CSF[15] - PBFT02 is positioned as a potentially transformative therapy for FTD-GRN patients, with no approved disease-modifying therapies currently available[32] - The company is pursuing a differentiated gene therapy approach in Huntington's disease, focusing on reducing MSH3 expression to decrease somatic instability in the HTT gene[27]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 OR 15(d) of The Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): January 12, 2026 MODERNA, INC. (Exact name of registrant as specified in its charter) Delaware 001-38753 81-3467528 325 Binney Street Cambridge, MA 02142 (Address of principal executive offices) (Zip code) Registrant's telephone number, including area code: (617) 714-6500 Not Applicable (Former ...

Financial Performance - Preliminary full year 2025 net revenues were $655.4 million, an increase of 8% compared to the prior year[4] - Fourth quarter net revenues were $174.4 million, also an increase of 8% compared to the same period in 2024[4] - The U.S. contributed $101.6 million to fourth quarter revenues, followed by Germany at $21.6 million, France at $20.5 million, and Japan at $10.2 million[4] - Cash, cash equivalents, and short-term investments were $448.3 million as of December 31, 2025, after repaying $561 million of convertible notes[4] Product Usage and Development - As of December 31, 2025, there were 4,620 total active patients on TTFields therapy globally, with 4,464 on Optune Gio and 122 on Optune Lua for NSCLC[8] - Optune Gio prescriptions for glioblastoma increased by 6% year-over-year, totaling 1,609 in the fourth quarter[4] - Novocure plans to stop reporting new prescriptions for indications that have been commercially available for over a year starting Q1 2026[7] - The company submitted the final module of its PMA application to the FDA for TTFields therapy for brain metastases from NSCLC in December 2025[7] - Topline data from the Phase 2 PANOVA-4 clinical trial in metastatic pancreatic cancer is expected in Q1 2026[7] - Novocure appointed Frank Leonard as CEO in December 2025, enhancing leadership for upcoming product launches[7] Treatment Risks and Side Effects - Optune Lua may cause treatment-related skin irritation and allergic reactions[24] - Potential adverse effects include overheating of the array leading to pain and local skin burns[24] - Users may experience infections at the site of contact with the arrays[24] - Local warmth and tingling sensations beneath the arrays are reported side effects[24] - Muscle twitching and skin breakdown/ulcers are also potential risks associated with Optune Lua[24]

Exhibit 99.1 Ionis well-positioned for continued momentum and substantial value creation in 2026 with two new independent launches and several pivotal data readouts CARLSBAD, Calif., January 12 – Ionis Pharmaceuticals, Inc. (Nasdaq: IONS) today announced highlights from the Company's 2025 achievements and provided additional updates on key milestones expected in 2026. Ionis will provide a business update at the 44th Annual J.P. Morgan Healthcare Conference on Tuesday, January 13 at 8:15am PT; the presentati ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): January 11, 2026 Registrant's Telephone Number, Including Area Code: 857 327-8775 (Former Name or Former Address, if Changed Since Last Report) Beam Therapeutics Inc. (Exact name of Registrant as Specified in Its Charter) (State or Other Jurisdiction of Incorporation) Delaware 001-39208 81-5238 ...

https://files.reportify.cc/m Utz Brands, Inc. Announces Preliminary Fourth Quarter and Fiscal Year 2025 Results Hanover, PA, January 12, 2026 (BUSINESS WIRE) – Utz Brands, Inc. (NYSE: UTZ) ("Utz" or the "Company"), a leading U.S. manufacturer of branded Salty Snacks and a small-cap growth and value Staples equity, today announced preliminary estimated Net Sales and Adjusted EBITDA results for the fourth quarter and fiscal year 2025 and provided a balance sheet update. The Company expects to report fourth qu ...

Financial Guidance - US Foods Holding Corp. reaffirmed its fiscal year 2025 guidance previously announced on November 6, 2025[4] Upcoming Events - The company will participate in the 28th Annual ICR Conference in Orlando on January 12, 2026[4] Investor Information - The press release regarding the financial results is available on the company's Investor Relations page[5]

Financial Performance - Regeneron reported Q4 2025 U.S. net sales of $1.1 billion, reflecting a year-over-year growth of 27%[6] - EYLEA HD and EYLEA global net sales reached $4.9 billion in the U.S. branded anti-VEGF category, maintaining a strong market position[6] - Dupixent global net sales increased to $754 million in Q4 2025, with a 27% year-over-year growth[6] - Capital returned to shareholders in 2025 totaled $3.8 billion, including $3.4 billion in share repurchases and $0.4 billion in dividends[6] - Approximately $1.5 billion remains under the current share repurchase program as of December 31, 2025[6] Research and Development - The company has 45 clinical programs across six core therapeutic areas, providing a robust foundation for future growth[4] - The company has internally discovered 14 therapies that have been approved, indicating strong R&D productivity[4] - Regeneron is leveraging the world's largest DNA and proteomics-linked healthcare database to enhance drug discovery and development[4] - The company is a leader in human antibodies and is pioneering bispecifics, siRNA, gene editing, and AAV gene therapy[4] - Estimated Non-GAAP R&D expense for 2026 is projected to be approximately $6.5 billion, with formal financial guidance to be provided at Q4 2025 earnings[6] - The internal R&D spend is aligned with the biopharma industry average of 43% of commercial cash flow, while external business development spend is at 27%[8] Market Opportunities - The global market opportunity across key therapeutic categories is projected to exceed $200 billion annually by 2030[9] - The estimated worldwide market sales for Geographic Atrophy in 2025 is approximately $1.1 billion, with a CAGR of about 34% from 2025 to 2030[15] - The U.S. treatment landscape shows approximately 30,000 patients in 1L (NDMM) and 17,000 patients in 2L, indicating significant market potential[14] Clinical Trials and Approvals - Positive Phase 3 results were demonstrated in allergy programs for cat (FelD1) and birch (BetV1) allergies, with registration-enabling studies set to begin in 2026[11] - The company is advancing a long-acting, fully-human IL-13 & IL-4 antibodies development plan, with first-in-human trials expected in 1H 2026[11] - The company anticipates pivotal data from the 1L metastatic melanoma trial for FIANLIMAB + LIBTAYO in 1H 2026, aiming to transform treatment paradigms[12] - Cemdisiran monotherapy reported the best MG-ADL improvement among C5 inhibitors, with FDA submission planned for Q1 2026 and decision expected by Q4 2026/Q1 2027[15] - The company is conducting 4 registrational studies for Lynozyfic, with 100% of evaluable patients achieving MRD-negativity in HRSMM and 1L multiple myeloma[14] - The anticipated pivotal data for the combination approach in PNH is expected in Q4 2026/Q1 2027[12] - The company is on track for FDA submission for gMG in Q1 2026, with pivotal data expected in Q4 2026/Q1 2027[12] - Regeneron is initiating trials for its investigational drug candidates in the anticoagulation market, with data expected in 2029 for one trial and 2028 for another[16] - Initiated additional Phase 3 trials in multiple myeloma and precursor conditions expected in 2026[19] - Reported results from Phase 3 trial in PNH anticipated in Q4 2026/Q1 2027[19] - Reported initial Phase 2 data in advanced NSCLC expected in 2026[19] - Initiated clinical program for atopic dermatitis with NDA submission for gMG in Q1 2026[19] - FDA decision for genetic hearing loss expected in 2026[19] - Reported interim results from lead-in cohort of Phase 3 trial in GA expected in 2026[19] - Initiated Phase 3 program in obesity with and without T2D expected in 2026[19] - Reported additional data from proof-of-concept data of combination of semaglutide and trevogrumab in obesity expected in 2026[19] - FDA decision for BP expected in Q1 2026[19] - Initiated clinical program for olatopratide and pralutamide expected in 2026[19] Strategic Focus - Regeneron expects to continue delivering growth through leadership in key therapeutic categories[6] - The company is focused on integrating genetics, proteomics, and big data to maintain competitive advantages in the market[4] - The company is prioritizing a combination approach with Praluent (PCSK9) to achieve over 50% LDL lowering along with weight loss[12] - Regeneron aims to achieve over 50% LDL lowering in combination therapies, which will be administered via weekly injections[17] - The anticoagulation market remains underpenetrated, with less than 50% of eligible patients receiving therapy due to safety concerns[16] - Regeneron is exploring preclinical solutions for muscle preservation in obesity treatment[17] Financial Commitments - $6 billion is committed to U.S. manufacturing and R&D infrastructure expansion over the coming years[6]

slide1 US-DOCS\166734234.2 Duolingo, Inc. 5900 Penn Avenue Pittsburgh, PA 15206 Main Office: 412-567-6602 January 9, 2026 Gillian Munson Employment Terms Dear Gillian: Duolingo, Inc., a Delaware corporation (the "Company"), is pleased to offer you employment in the exempt position of Chief Financial Officer, in which you will be responsible for such duties as are normally associated with such position or as otherwise determined by your supervisor to the extent not materially inconsistent with your title and ...