Verastem Oncology Provides Preliminary Fourth Quarter and 2025 Revenue and Business Updates and Outlines 2026 Strategic Priorities for Novel Portfolio Targeting RAS/MAPK Pathway-Driven Cancers

On February 4, 2026 Verastem Oncology (Nasdaq: VSTM), a biopharmaceutical company committed to advancing new medicines for patients with RAS/MAPK pathway-driven cancers, reported preliminary, unaudited fourth quarter and full year 2025 net product revenues for AVMAPKI FAKZYNJA CO-PACK, business updates, and 2026 priorities.

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"2025 was a transformative year for Verastem Oncology and the patients we serve. We transitioned to a commercial-stage company with the launch of AVMAPKI FAKZYNJA CO-PACK, the first treatment specifically approved by the FDA for KRAS-mutated recurrent low-grade serous ovarian cancer (LGSOC). We also advanced multiple clinical programs across several RAS/MAPK pathway-driven solid tumor cancers," said Dan Paterson, president and chief executive officer at Verastem Oncology. "In 2026, we are well-positioned to drive sustainable growth with our successful commercial launch and to accelerate our clinical path for VS-7375, our potential best-in-class oral KRAS G12D (ON/OFF) inhibitor, with several important data readouts and preparations for potential registration-directed clinical trials."

Financial Update

· Based on preliminary, unaudited results, Verastem expects AVMAPKI FAKZYNJA CO-PACK net product revenues of approximately $17.5 million for the fourth quarter of 2025 and approximately $30.9 million for the full year 2025. Full year 2025 net product revenue reflects the launch period of May, following U.S. Food and Drug Administration (FDA) approval, through December 2025.
· The Company also announced that as of January 25, 2026 outstanding cash warrants had been exercised, netting $29.4 million. No cash exercise warrants remain outstanding.
· As of December 31, 2025, the Company had cash, cash equivalents, and investments (unaudited) of $205 million; on a pro forma basis, taking into consideration the net proceeds of the cash exercise warrants, cash, cash equivalents and investments were $234 million. With its ongoing product revenue, recent equity financing, and exercise of the remaining cash warrants, the Company expects its cash runway to extend into the first half of 2027.
· Given the growth trajectory of the AVMAPKI FAKZYNJA CO-PACK, Verastem anticipates the LGSOC commercial launch and development program will be self-sustaining by the second half of 2026.

2026 Priorities

In 2026, Verastem will continue to focus on maximizing the commercial launch of AVMAPKI FAKZYNJA CO-PACK while advancing its differentiated pipeline targeting RAS/MAPK-pathway driven cancers to create sustainable long-term growth:

1. AVMAPKI FAKZYNJA CO-PACK (avutometinib; defactinib) – the first treatment specifically approved by the FDA for adults with KRAS-mutated recurrent LGSOC who have received prior systemic therapy. The combination is being evaluated in an ongoing international Phase 3 trial, RAMP 301, in recurrent LGSOC with or without a KRAS mutation. The trial is fully enrolled, as of December 2025, and will serve as a confirmatory study for the initial indication and has the potential to expand the indication regardless of KRAS mutation status. The results will also be leveraged for potential geographic expansion.

The Company announced today updated data from the ongoing RAMP201J Phase 2 clinical trial in Japan evaluating the combination in patients with LGSOC with or without a KRAS mutation. As of the data cutoff on January 30, 2026, 16 patients were efficacy evaluable by investigator assessment, having at least one post-baseline assessment with a median follow-up of 10 months. Of the 16 total patients, a confirmed overall response rate (ORR) of 38% (6/16) was achieved. Among patients with KRAS-mutated recurrent LGSOC, the confirmed ORR was 57% (4/7) and the disease control rate (DCR) was 100% (7/7). Among patients with KRAS wild-type recurrent LGSOC, the confirmed ORR was 22% (2/9) and the DCR was 89% (8/9). Of the 16 patients enrolled, 11 patients remain on treatment. No patients discontinued due to an adverse event. The safety profile was similar to previously reported data.

Verastem expects to:

· Maximize adoption of AVMAPKI FAKZYNJA CO-PACK in the U.S. as the treatment of choice at the earliest recurrence, leveraging its robust clinical data.
· Report a topline readout of the primary endpoint in the RAMP 301 trial in mid-2027.
· Continue to pursue regulatory paths for potential expansion of the product launch into Europe and Japan.

2. VS-7375 – is an investigational, highly selective and oral KRAS G12D (ON/OFF) inhibitor being evaluated in an international Phase 1/2 trial in advanced KRAS G12D solid tumors. The trial continues to enroll in both the monotherapy dose-escalation and dose-expansion cohorts and multiple dose-escalation combination cohorts in various solid tumors including colorectal cancer (CRC), pancreatic ductal adenocarcinoma (PDAC), and non-small cell lung cancer (NSCLC).

As previously reported, the Company cleared the 400, 600, and 900 mg once daily (QD) dose levels with no dose-limiting toxicities (DLTs) and no major toxicities. The monotherapy expansion cohorts have been initiated, and the cohort sizes have been expanded in second-line (2L) PDAC, 2L/3L NSCLC, and 2L+ tumor agnostic solid tumors, including biliary tract cancer (BTC) and endometrial cancer. The Company cleared the 400 mg QD dose in combination with cetuximab with no DLTs and is currently evaluating the 600 mg QD dose level with cetuximab. The combination dose escalation cohorts were initiated in first-line (1L) NSCLC and 2L PDAC at the end of 2025.

Verastem expects to:

· Report an interim update on the Phase 1/2 trial of VS-7375 in 1H 2026.
· Select the recommended Phase 2 dose (RP2D) with cetuximab and initiate the CRC combination expansion cohort in 1H 2026.
· Engage with the FDA in 1H 2026 to discuss its development path forward, including potential registration-directed clinical trials in PDAC, NSCLC, and CRC.
· Complete enrollment in combination dose-escalation cohorts in mid-2026.
· Complete enrollment in monotherapy expansion cohorts in 2H 2026.
· Select the RP2D and plan to initiate the PDAC and NSCLC combination expansion cohorts in 2H 2026.

3. Avutometinib Plus Defactinib – is being evaluated in an ongoing RAMP 205 study in combination with standard-of-care chemotherapy in the front line for patients with metastatic PDAC. At the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in 2025, the Company reported that the first 12 patients enrolled to dose level 1 (DL1) in the RAMP 205 study reported an ORR of 83% (10/12). Seventeen additional patients were enrolled in the DL1 expansion between May and August 2025, and with a minimum follow-up of approximately 4 months, the majority of these patients remain on treatment as of January 2026.

Verastem expects to:

· Report an update on the safety and efficacy of the RAMP 205 expansion cohort with at least six months of follow-up on all patients in Q2 2026.

1The information presented above is unaudited and reflects preliminary estimates subject to the completion of financial closing procedures and any adjustments that may result from the finalization of the quarter and annual review of the Company’s financial statements by external auditors. Verastem plans to report the final 4Q2025 and full year 2025 results during its fourth quarter 2025 earnings call in early March 2026

Guggenheim Emerging Outlook: Biotech Summit

The Company’s leadership will participate in a fireside chat at the Guggenheim Emerging Outlook: Biotech Summit on Wednesday, February 11, 2026, at 2:00 pm ET in New York. A live webcast of the fireside chat can be accessed under "Events & Presentations" on the Company’s website at www.verastem.com. A replay of the webcast will be archived on the website for approximately 90 days following the presentation.

About AVMAPKI and FAKZYNJA Combination Therapy  

AVMAPKI (avutometinib) inhibits MEK kinase activity while also blocking the compensatory reactivation of MEK by upstream RAF. RAF and MEK proteins are regulators of the RAS/RAF/MEK/ERK (MAPK) pathway. Blocking RAF and/or MEK activates FAK, a key mediator of drug resistance. FAKZYNJA (defactinib) is a FAK inhibitor and together, the avutometinib and defactinib combination was designed to provide a more complete blockade of the signaling that drives the growth and drug resistance of RAS/MAPK pathway-dependent tumors.

The U.S. Food and Drug Administration (FDA) approved AVMAPKI FAKZYNJA CO-PACK (avutometinib capsules; defactinib tablets) for the treatment of adult patients with KRAS-mutated recurrent LGSOC who have received prior systemic therapy on May 8, 2025. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. Verastem is conducting RAMP 301 (GOG-3097/ENGOT-ov81/GTG-UK) (NCT06072781), an international Phase 3 confirmatory trial evaluating the combination of avutometinib and defactinib versus standard chemotherapy or hormonal therapy for the treatment of recurrent low-grade serous ovarian cancer (LGSOC) with and without a KRAS mutation. Verastem is also evaluating avutometinib plus defactinib with standard-of-care chemotherapy as a potential treatment in the first-line for patients with advanced pancreatic cancer (RAMP 205; NCT05669482). Avutometinib and defactinib are not approved by the FDA or any other regulatory authority, either in combination or with other therapies, for any of these investigative uses. Neither avutometinib nor defactinib are approved by the FDA or any other regulatory authority on a stand-alone basis for any use.

AVMAPKI FAKZYNJA CO-PACK U.S. Indication  

Indication  

AVMAPKI FAKZYNJA CO-PACK is indicated for the treatment of adult patients with KRAS-mutated recurrent low-grade serous ovarian cancer (LGSOC) who have received prior systemic therapy.  

This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.  

Important Safety Information  

Warnings and Precautions  

· Ocular Toxicities: Ocular toxicities, including visual impairment and vitreoretinal disorders, occurred. Perform comprehensive ophthalmic evaluation at baseline, prior to cycle 2, every three cycles thereafter, and as clinically indicated. Withhold AVMAPKI FAKZYNJA CO-PACK for ocular toxicities until improvement at the same or reduced dose. Permanently discontinue AVMAPKI FAKZYNJA CO-PACK for any grade 4 toxicity.   
· Serious Skin Toxicities: Skin toxicities, including photosensitivity and severe cutaneous adverse reactions (SCARSs) occurred. Adhere to concomitant medications. Monitor for skin toxicities and interrupt, reduce or permanently discontinue AVMAPKI FAKZYNJA CO-PACK based on severity, tolerability and duration.  
· Hepatotoxicity: Monitor liver function tests prior to each cycle, on day 15 of the first 4 cycles, and as clinically indicated. Withhold, reduce or discontinue AVMAPKI FAKZYNJA CO-PACK based on severity and persistence of abnormality.   
· Rhabdomyolysis: Monitor creatine phosphokinase prior to the start of each cycle, on day 15 of the first four cycles, and as clinically indicated. If increased CPK occurs, evaluate patients for rhabdomyolysis or other causes. Withhold, reduce or permanently discontinue AVMAPKI FAKZYNJA CO-PACK based on severity and duration of the adverse reaction.   
· Embryo-Fetal Toxicity: AVMAPKI FAKZYNJA CO-PACK can cause fetal harm. Advise patients of the potential risk to a fetus and to use effective contraception.  

Adverse Reactions  

The most common (≥ 25%) adverse reactions, including laboratory abnormalities, were increased creatine phosphokinase, nausea, fatigue, increased aspartate aminotransferase, rash, diarrhea, musculoskeletal pain, edema, decreased hemoglobin, increased alanine aminotransferase, vomiting, increased blood bilirubin, increased triglycerides, decreased lymphocyte count, abdominal pain, dyspepsia, dermatitis acneiform, vitreoretinal disorders, increased alkaline phosphatase, stomatitis, pruritus, visual impairment, decreased platelet count, constipation, dry skin, dyspnea, cough, urinary tract infection, and decreased neutrophil count.  

Drug Interactions  

· Strong and moderate CYP3A4 inhibitors: Avoid concomitant use with AVMAPKI FAKZYNJA CO-PACK.  
· Strong and moderate CYP3A4 inducers: Avoid concomitant use with AVMAPKI FAKZYNJA CO-PACK.  
· Warfarin: Avoid concomitant use of AVMAPKI FAKZYNJA CO-PACK with warfarin and use an alternative to warfarin.   
· Gastric acid reducing agents: Avoid concomitant use of AVMAPKI FAKZYNJA CO-PACK with proton pump inhibitors (PPIs) or H2 receptor antagonists. If use of an acid-reducing agent cannot be avoided, administer FAKZYNJA 2 hours before or 2 hours after the administration of a locally acting antacid.   

Use in Specific Populations  

· Lactation: Advise not to breastfeed.  
· Fertility: May impair fertility in males and females.  

About VS-7375, an Oral KRAS G12D (ON/OFF) Inhibitor  

VS-7375 is a potential best-in-class, potent, and selective oral KRAS G12D dual ON/OFF inhibitor. VS-7375 is the lead program from the Verastem Oncology discovery and development collaboration with GenFleet Therapeutics. Verastem initiated VS-7375-101, an international Phase 1/2 clinical trial, in June of 2025 in the U.S., that is evaluating the safety and efficacy of VS-7375 in patients with advanced KRAS G12D mutant solid tumors. Verastem announced in April 2025 that the U.S. Investigational New Drug (IND) application for VS-7375 was cleared.

(Press release, Verastem, FEB 4, 2026, View Source [SID1234662481])

Defence Therapeutics To Present At The World Adc Europe 2026 Showcasing Accum Precision Intracellular Drug-Delivery Platform

On February 4, 2026 Defence Therapeutics Inc. ("Defence" or the "Company"), a publicly traded biotechnology and precision intracellular drug-delivery company, reported that it will present at World ADC Europe 2026, taking place February 23–26, 2026, in London, UK.

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Defence will showcase its proprietary Accum platform, a breakthrough intracellular delivery technology designed to actively transport biologic payloads to their intended intracellular and nuclear targets, unlocking the full potential of antibody-drug conjugates ("ADCs") and other complex cancer biologics by increasing intracellular potency and reducing the doses required to achieve therapeutic efficacy.

"At Defence, our mission is to transform advanced biologics into safer, more effective first-line cancer therapies through precision intracellular delivery," said Sébastien Plouffe, CEO of Defence Therapeutics. "World ADC Europe is a premier global forum to engage with innovators and potential partners who share our vision of a future where every cancer therapy reaches its full potential."

This announcement is being made on World Cancer Day, underscoring Defence’s commitment to accelerating next-generation cancer therapies that address critical unmet medical needs. "On World Cancer Day, we are reminded of the urgency to bring smarter, more precise cancer treatments to patients," added Mr. Plouffe. "Accum has the potential to help cancer therapies reach their full potential and deliver better outcomes for patients."

At the conference, Defence aims to engage with pharmaceutical and biotechnology companies and advance strategic partnering discussions around co-developing Accum-enabled ADCs and precision oncology biologics, leveraging Accum to enhance intracellular delivery and therapeutic performance. To explore partnering opportunities or schedule a meeting, please contact [email protected].

(Press release, Defence Therapeutics, FEB 4, 2026, View Source;utm_medium=rss&utm_campaign=defence-therapeutics-to-present-at-the-world-adc-europe-2026-showcasing-accum-precision-intracellular-drug-delivery-platform [SID1234662467])

Rezolute to Participate in the Guggenheim Emerging Outlook: Biotech Summit 2026

On February 4, 2026 Rezolute, Inc. (Nasdaq: RZLT) ("Rezolute" or the "Company"), a late-stage rare disease company focused on treating hypoglycemia caused by all forms of hyperinsulinism (HI), reported that management will participate in the Guggenheim Emerging Outlook: Biotech Summit 2026, taking place February 11-12, 2026 in New York.

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Management will be participating in one-on-one investor meetings throughout the conference. Investors interested in scheduling a meeting with the Rezolute management team should contact their Guggenheim representative.

(Press release, Rezolute, FEB 4, 2026, View Source [SID1234662482])

Lilly reports fourth-quarter 2025 financial results and provides 2026 guidance

On February 4, 2026 Eli Lilly and Company (NYSE: LLY) reported its financial results for the fourth-quarter of 2025 and provided 2026 financial guidance.

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"2025 was an important year for Lilly," said David A. Ricks, Lilly’s chair and CEO. "We reached millions more patients—launching Inluriyo, expanding Mounjaro and Kisunla globally, and submitting orforglipron for approval. We expanded our manufacturing capacity, and through our U.S. government agreement, opened new access to obesity medicines. Entering our 150th year with a deep pipeline and platforms like LillyDirect, we’re positioned to reach more patients than ever and expand our global health impact."

Financial Results

$ in millions, except

per share data

Fourth-Quarter

2025

2024

% Change

Revenue

$ 19,292

$ 13,533

43 %

Net income – Reported

6,636

4,410

50 %

Earnings per share – Reported

7.39

4.88

51 %

Net income – Non-GAAP

6,771

4,806

41 %

Earnings per share – Non-GAAP

7.54

5.32

42 %

A discussion of the non-GAAP financial measures is included below under "Reconciliation of GAAP Reported to Selected Non-GAAP Adjusted Information (Unaudited)."

Fourth-Quarter Reported Results
In Q4 2025, worldwide revenue was $19.3 billion, an increase of 43% compared with Q4 2024, driven by a 46% increase in volume, partially offset by a 5% decrease due to lower realized prices. Key Products[1] revenue grew to $13.8 billion in Q4 2025, led by Mounjaro and Zepbound.

Revenue in the U.S. increased 43% to $12.9 billion, driven by a 50% increase in volume, partially offset by a 7% decrease due to lower realized prices. The increase in U.S. volume and decline in realized prices were driven by Zepbound and Mounjaro.

Revenue outside the U.S. increased 43% to $6.4 billion, driven by a 38% increase in volume and to a lesser extent a 4% favorable impact on foreign exchange rates. The volume increase outside the U.S. was driven primarily by Mounjaro, partially offset by Jardiance. Volume growth was negatively impacted by a one-time benefit of $300 million related to Jardiance, associated with an amendment to the company’s collaboration with Boehringer Ingelheim, in Q4 2024.

1 The Company defines Key Products as Ebglyss, Inluriyo (effective Q4 2025), Jaypirca, Kisunla, Mounjaro, Omvoh, Verzenio and Zepbound.

Gross margin increased 43% to $15.9 billion in Q4 2025. Gross margin as a percent of revenue was 82.5%, an increase of 0.3 percentage points. The increase in gross margin percent was primarily driven by favorable product mix and improved cost of production, partially offset by lower realized prices.

In Q4 2025, research and development expenses increased 26% to $3.8 billion, or 20% of revenue, driven by continued investments in the company’s early and late-stage portfolio.

Marketing, selling and administrative expenses increased 29% to $3.1 billion in Q4 2025, primarily driven by promotional efforts supporting ongoing and planned launches.

The effective tax rate was 19.7% in Q4 2025 compared with 12.5% in Q4 2024 primarily driven by a less favorable jurisdictional mix of earnings in Q4 2025 relative to Q4 2024. Additionally, the effective tax rate for Q4 2025 was unfavorably impacted by U.S. tax law changes enacted earlier in 2025.

In Q4 2025, net income and earnings per share (EPS) were $6.6 billion and $7.39, respectively, compared with net income of $4.4 billion and EPS of $4.88 in Q4 2024. EPS in Q4 2025 and Q4 2024 included acquired IPR&D charges of $0.52 and $0.19, respectively.

Fourth-Quarter Non-GAAP Measures
On a non-GAAP basis, Q4 2025 gross margin increased 42% to $16.0 billion. Gross margin as a percent of revenue was 83.2%, consistent with Q4 2024. Favorable product mix and improved cost of production were offset by lower realized prices.

The non-GAAP effective tax rate was 19.7% in Q4 2025 compared with 13.2% in Q4 2024 primarily driven by a less favorable jurisdictional mix of earnings in Q4 2025 relative to Q4 2024. Additionally, the effective tax rate for Q4 2025 was unfavorably impacted by U.S. tax law changes enacted earlier in 2025.

On a non-GAAP basis, Q4 2025 net income and EPS were $6.8 billion and $7.54, respectively, compared with net income of $4.8 billion and EPS of $5.32 in Q4 2024. Non-GAAP EPS in Q4 2025 and Q4 2024 included acquired IPR&D charges of $0.52 and $0.19, respectively.

For further detail on non-GAAP measures, see the reconciliation below as well as the "Reconciliation of GAAP Reported to Selected Non-GAAP Adjusted Information (Unaudited)" table later in this press release.

Fourth-Quarter

2025

2024

% Change

Earnings per share (reported)

$ 7.39

$ 4.88

51 %

Amortization of intangible assets

.11

.12

Asset impairment, restructuring and other special charges

.07

.30

Net losses (gains) on investments in equity securities

(.03)

.02

Earnings per share (non-GAAP)

$ 7.54

$ 5.32

42 %

Acquired IPR&D

.52

.19

174 %

Numbers may not add due to rounding

Selected Revenue Highlights

(Dollars in millions)

Fourth-Quarter

Full Year

Selected Products

2025

2024

% Change

2025

2024

% Change

Mounjaro

$ 7,409

$ 3,530

110 %

$ 22,965

$ 11,540

99 %

Zepbound(1)

4,261

1,907

123 %

13,542

4,926

175 %

Verzenio

1,604

1,555

3 %

5,723

5,307

8 %

Total Revenue

19,292

13,533

43 %

65,179

45,043

45 %

(1) Tirzepatide is marketed for obesity under the brand name Zepbound in Canada, Japan, and the United States.

Mounjaro
For Q4 2025, worldwide Mounjaro revenue increased 110% to $7.4 billion. U.S. revenue was $4.1 billion, an increase of 57%, reflecting strong demand, partially offset by lower realized prices. Revenue outside the U.S. increased to $3.3 billion compared with $899 million in Q4 2024, primarily driven by volume growth.

Zepbound
For Q4 2025, U.S. Zepbound revenue increased 122% to $4.2 billion, compared with $1.9 billion in Q4 2024, primarily driven by increased demand, partially offset by lower realized prices.

Verzenio
For Q4 2025, worldwide Verzenio revenue increased 3% to $1.6 billion. U.S. revenue was $997 million, a decrease of 4%. Revenue outside the U.S. was $608 million, an increase of 18%, primarily driven by volume growth.

Lilly shared numerous updates recently on key regulatory, clinical, business development and other events, including:

Regulatory

Lilly’s sofetabart mipitecan receives U.S. FDA’s Breakthrough Therapy designation for the treatment of certain patients with platinum-resistant ovarian cancer (announcement)

U.S. FDA approves expanded indication for Lilly’s Jaypirca (pirtobrutinib), the first and only non-covalent (reversible) BTK inhibitor, for adults with relapsed or refractory CLL/SLL previously treated with a covalent BTK inhibitor (announcement)

Clinical

Lilly’s Taltz (ixekizumab) and Zepbound (tirzepatide) used together delivered superior efficacy in first-of-its-kind Phase 3b trial for adults with active psoriatic arthritis and obesity or overweight (announcement)

Lilly’s orforglipron helped people maintain weight loss after switching from injectable incretins to oral GLP-1 therapy in first-of-its-kind Phase 3 trial (announcement)

Updated data for Lilly’s Inluriyo (imlunestrant) reinforce efficacy results as monotherapy and in combination with Verzenio (abemaciclib) in ER+, HER2- advanced breast cancer (announcement)

Lilly’s triple agonist, retatrutide, delivered weight loss of up to an average of 71.2 lbs along with substantial relief from osteoarthritis pain in first successful Phase 3 trial (announcement)

Lilly’s Jaypirca (pirtobrutinib) significantly improved progression-free survival, reducing the risk of progression or death by 80%, versus chemoimmunotherapy in patients with treatment-naïve CLL/SLL (announcement)

Lilly’s Jaypirca (pirtobrutinib) met its primary endpoint in first-of-its-kind, head-to-head Phase 3 study versus Imbruvica (ibrutinib) (announcement)

Lilly’s selective amylin agonist, eloralintide, demonstrated meaningful weight loss and favorable tolerability in a Phase 2 study of adults with obesity or overweight (announcement)

Other

Lilly selects Pennsylvania as home for its newest injectable medicine and device manufacturing facility (announcement)

NVIDIA and Lilly Announce Co-Innovation AI Lab to Reinvent Drug Discovery In the Age of AI (announcement)

Lilly to acquire Ventyx Biosciences to advance oral therapies targeting inflammatory-mediated diseases (announcement)

Lilly to build $6 billion facility to manufacture active pharmaceutical ingredients in Alabama (announcement)

Lilly and Adverum announce expiration and completion of Adverum tender offer and acquisition (announcement)

Carolyn Bertozzi returns to Lilly board of directors (announcement)

Lilly announces plans to open Lilly Gateway Labs site in Philadelphia (announcement)

Lilly announces two new Executive Committee members and expansion of leadership roles to prepare for next wave of growth (announcement)

Lilly and U.S. government agree to expand access to obesity medicines to millions of Americans (announcement)

Lilly plans to build a new $3 billion facility to boost oral medicine manufacturing capacity in Europe for patients worldwide (announcement)

For information on important public announcements, visit the news section of Lilly’s website.

2026 Financial Guidance
In addition to providing guidance for GAAP revenue, Lilly provides guidance for certain non-GAAP measures. Lilly does not provide reconciliations of forward-looking non-GAAP measures to the most directly comparable GAAP measures because comparable GAAP measures are not reasonably accessible or reliable due to the inherent difficulty in forecasting and quantifying measures that would be necessary for a reconciliation. In particular, Lilly cannot reasonably predict certain items including net gains and losses on equity securities, asset impairment, acquisition or divestiture-related items, restructuring and other adjustments, without unreasonable effort. These items are uncertain, depend on various factors, and could have a material impact on Lilly’s reported results in accordance with GAAP.

The following table summarizes the company’s full-year 2026 financial guidance:

2026 Guidance

Revenue

$80 to $83 billion

Performance Margin(1)(2)

46.0% to 47.5%

Tax Rate(2)(3)

18% to 19%

Earnings per Share(2)(3)(4)

$33.50 to $35.00

(1) The Company defines performance margin as gross margin less research and development
and marketing, selling, and administrative expenses divided by revenue.

(2) Excludes the impact of intangible asset amortization.

(3) Guidance does not include acquired in-process research and development (IPR&D) either
incurred or expected to be incurred, after December 31, 2025.

(4) 2026 assumes shares outstanding of approximately 894 million

Webcast of Conference Call
As previously announced, investors and the general public can access a live webcast of the Q4 2025 financial results conference call through a link on Lilly’s website at investor.lilly.com/webcasts-and-presentations. The conference call will begin at 10 a.m. Eastern time today and will be available for replay via the website.

(Press release, Eli Lilly, FEB 4, 2026, View Source [SID1234662468])

Beyond Cancer Abstract Featuring Phase 1 Data on Intratumoral Ultra-High Concentration Nitric Oxide (UNO) in Solid Tumor Metastases to be Presented at the AACR Annual Meeting 2026

On February 4, 2026 Beyond Cancer, Ltd., a clinical stage biotechnology company developing ultra-high concentration nitric oxide (UNO) as an immunotherapeutic for solid tumors and subsidiary of Beyond Air, Inc. (NASDAQ: XAIR), reported being selected to present an abstract featuring data from the Phase 1 trial of intratumoral UNO in solid tumor metastases at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2026, which is scheduled to be held from Friday, April 17th, through Wednesday, April 22nd, at the San Diego Convention Center in San Diego, California. The original submitted abstract titles and text are scheduled to be published in an Online Itinerary Planner on March 17, 2026 at 4:30 PM ET / 1:30 PM PT.

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AACR Annual Meeting 2026 Abstract Details:
Presenter: Amichay Meirovitz, MD, Soroka University Medical Center, Beersheba, Israel
Session Category: Experimental and Molecular Therapeutics
Session Title: Innovative Therapeutic Modalities and Translational Platforms
Session Start: April 19, 2026 at 5:00 PM ET / 2:00 PM PT
Session End: April 19, 2026 at 8:00 PM ET / 5:00 PM PT
Location: Poster Section 13, San Diego Convention Center
Poster Board Number: 22
Poster Number: 304

(Press release, Beyond Air, FEB 4, 2026, View Source [SID1234662483])