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]

Revenue Expectations - Moderna expects approximately $1.9 billion in revenue for the fiscal year ended December 31, 2025[4] Operating Expenses - The company anticipates GAAP operating expenses of $5.0 - $5.2 billion for the fiscal year ended December 31, 2025[4] Financial Position - Moderna's expected cash, cash equivalents, and investments in marketable securities as of December 31, 2025, is approximately $8.1 billion[4]

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 ...

Financial Position - As of December 31, 2025, Beam Therapeutics estimates its cash, cash equivalents, and marketable securities to be approximately $1.25 billion[6]. - The company is assessing the sufficiency of its capital resources to fund operating expenses and capital expenditures[11]. - The company may receive additional cash consideration related to the acquisition of Orbital Therapeutics by Bristol-Myers Squibb[11]. - The financial results for the fourth quarter and fiscal year ended December 31, 2025, are still being finalized and are subject to completion of financial statement closing procedures[7]. - The company cautions that its estimated cash balance is preliminary and should not be relied upon without further context regarding its financial condition[7]. Corporate Developments - The company announced progress across its base editing portfolio and outlined key anticipated milestones in a press release dated January 11, 2026[9]. - Beam Therapeutics plans to present at the 44th Annual J.P. Morgan Healthcare Conference on January 13, 2026, showcasing its corporate presentation[9]. Research and Development - The company is focused on developing life-long, curative, precision genetic medicines through base editing technology[11]. - Beam Therapeutics is evaluating therapeutic applications for its technology, including Sickle Cell Disease (SCD), Alpha-1 Antitrypsin Deficiency (AATD), and Glycogen Storage Disease Type 1a (GSD1a)[11]. - The company anticipates potential regulatory interactions and filings related to its clinical trials for product candidates such as risto-cel, BEAM-103, BEAM-301, and BEAM-302[11].

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]

Compensation and Benefits - Duolingo, Inc. offers a base salary of $800,000 annually for the Chief Financial Officer position[1] - The CFO will receive restricted stock units (RSUs) valued at $14 million, with vesting starting at 25% on February 15, 2027[1] - Annual equity awards for the CFO are expected to be approximately $4 million, contingent on continued employment[1] - The CFO will be eligible for standard employee benefits, including medical insurance and retirement plans[2] - The Company will cover healthcare premiums for the Executive and dependents for up to twelve months following termination under certain conditions[14] - Executive's benefits are limited to accrued but unpaid salary, bonus, and expense reimbursement, with healthcare coverage options under COBRA[16] Employment Terms - The employment is "at will," allowing either party to terminate the relationship at any time[2] - The Company emphasizes that the employment relationship is at-will, allowing for termination without cause or notice[9] - The Agreement includes provisions for the Executive to resign from all offices and directorships upon termination[15] Confidentiality and Intellectual Property - The CFO must sign a Proprietary Information and Invention Assignment Agreement to protect the company's confidential information[5] - The agreement includes provisions for the assignment of all inventions conceived during employment to the company[6] - The CFO is required to maintain records of all employment inventions, which remain the company's property[6] - Confidentiality and non-disparagement clauses are included, prohibiting both parties from disparaging each other publicly or privately[18] Severance and Change in Control - The Company has established a Change in Control and Severance Agreement to provide financial security and incentives for executives during potential acquisition scenarios[13] - In the event of a Covered Termination, the Executive is entitled to a severance payment equal to twelve months of base salary, payable in a cash lump sum[14] - If a Covered Termination occurs during a Change in Control Period, the Executive will receive a severance payment that includes a pro-rated portion of the target annual bonus[15] - All unvested equity awards will automatically vest upon a Covered Termination during a Change in Control Period[15] - The Company may reduce severance benefits by any other severance payments or benefits payable to the Executive upon termination[15] - "Constructive Termination" allows for resignation under certain conditions, including a material reduction in compensation or job responsibilities[17] - The Company must assume obligations under the agreement in the event of a successor entity following a change in control[17] Legal and Dispute Resolution - The agreement is governed by the laws of the Commonwealth of Pennsylvania, ensuring legal compliance[9] - The agreement represents the entire understanding between the parties, superseding any prior agreements regarding severance or change in control benefits[20] - Disputes arising from the agreement will be resolved through binding arbitration in Allegheny County, Pennsylvania[18] - Payments deemed deferred compensation will not be made until a "separation from service" occurs, with specific timing for installment payments[19] - The agreement may be executed in counterparts, each considered an original document[20] Goodwill and Company Strategy - The Company acknowledges the importance of maintaining goodwill with business partners and employees as part of its competitive strategy[6]

Financial Performance - The net loss for the three months ended December 31, 2025, was $0.8 million, or $0.02 per share, compared to a net loss of $0.5 million, or $0.01 per share, for the same period in 2024[6] - For the six months ended December 31, 2025, the net loss was $43.4 million, or $0.44 per share, compared to a net loss of $2.5 million, or $0.06 per share, for the same period in 2024[6] - The adjusted net loss for the three months ended December 31, 2025, was $5.3 million, or $0.06 per share, compared to an adjusted net loss of $1.9 million, or $0.05 per share, for the prior-year period[6] - The adjusted net loss for the six months ended December 31, 2025, was $13.6 million, or $0.15 per share, compared to an adjusted net loss of $3.3 million, or $0.08 per share, for the prior-year period[6] - Operating cash outflows for the six-month period totaled $7.6 million, primarily due to expenditures associated with the Elk Creek drilling program and feasibility study updates[7] Cash Position - As of December 31, 2025, NioCorp had a record cash balance of $307 million, following significant derisking of the Elk Creek Critical Minerals Project[3] Project Developments - The U.S. Department of Defense awarded Elk Creek Resources Corp. up to $10 million to support activities related to the Elk Creek Critical Minerals Project[3] - NioCorp completed an infill drilling campaign and closed on the acquisition of scandium alloy manufacturing assets during the reporting period[3] - The company is developing a critical minerals project expected to produce niobium, scandium, and titanium, with potential for rare earth production[14] Risks and Uncertainties - NioCorp faces significant risks including trade policies, inflationary pressures, and climate change impacts that may affect its operations[18] - The company acknowledges the speculative nature of mineral exploration and development, which includes risks of diminishing reserves and resources[18] - NioCorp's management emphasizes the possibility of cost overruns and unanticipated expenses in development programs[18] - There are concerns regarding the management of the water balance at the Elk Creek Project site and land reclamation requirements[18] - The company has not secured insurance covering all of its operations, which poses additional risks[18] - NioCorp warns that actual results may materially differ from projections if risks or uncertainties materialize[19] - The company does not undertake any obligation to update forward-looking statements unless required by law[20] Reporting and Compliance - NioCorp plans to file its unaudited interim condensed consolidated financial statements for the three- and six-month periods ended December 31, 2025, by February 16, 2026[8]