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D3 Bio Presents KRAS Pipeline Updates at AACR 2026; Elisrasib (D3S-001), a Next-Generation KRAS G12C Inhibitor, Shows Strong Phase 2 Efficacy Across Multiple Tumor Types

On April 29, 2026 D3 Bio Inc., a global clinical-stage biotechnology company dedicated to developing innovative oncology therapeutics, reported new phase 2 clinical data from its lead asset elisrasib (D3S-001), a next-generation KRAS G12C inhibitor, alongside additional clinical and preclinical results from its KRAS-focused pipeline. The phase 2 studies demonstrate that elisrasib delivers broad antitumor activity across multiple KRAS G12C-mutant solid tumors, including NSCLC, CRC, and PDAC.

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Phase 2 data for elisrasib were shared as oral presentations at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2026 during both the Clinical Plenary Session (Abstract CT020) and the Clinical Trials Mini-Symposium (Abstract CT303) in San Diego, CA.

Extensive and Durable Clinical Activity Observed Across Indications

In 2L+ KRAS G12Ci-naïve NSCLC (n=68), elisrasib demonstrated robust efficacy at the RP2D (600 mg QD) with an ORR of 58.8%, median duration of response (mDoR) of 16.5 months, and mPFS of 12.2 months. Among late-line NSCLC patients refractory to prior KRAS G12C inhibitor therapy (n=31), an ORR of 32.3%, mDoR of 15.6 months, and mPFS of 8.1 months were recorded. In previously treated CRC, elisrasib showed significant efficacy as both monotherapy (n=32, ORR 46.9%, mDoR 13.1 months, and mPFS 9.5 months) and in combination with cetuximab (n=29, ORR 62.1%, mDoR 7.0 months, and mPFS 8.2 months). Further studies are planned to evaluate optimized combination strategies to enhance the durability of response in CRC. For late-line PDAC, monotherapy (n=20) achieved an ORR of 65.0%, mDoR of 10.8 months, and mPFS of 13.5 months.

Favorable Safety Profile

Elisrasib was well-tolerated across NSCLC, CRC, and PDAC populations. Grade 3 or higher treatment-related adverse events (TRAEs) ranged between 8.7% and 15.6% across these indications. Combination therapy with cetuximab was associated with a higher incidence of Grade 3 TRAEs, which were manageable and largely attributed to cetuximab. Only one transient, asymptomatic Grade 4 hypokalemia event was reported, with no other Grade 4 or 5 TRAEs observed.

Expert Commentary

"Elisrasib demonstrates the ability to provide deeper, longer-lasting tumor responses, even in cases where first-generation KRAS G12C inhibitors failed. Overall, these findings indicate that elisrasib may significantly improve treatment for lung cancer patients with KRAS G12C mutations," stated Professor Byoung Chul Cho, MD, PhD, Yonsei Cancer Center, Yonsei University College of Medicine, Korea, and lead study investigator. "Among patients whose disease progressed on first-generation inhibitors, we found five cases of KRAS gene amplification, an important mechanism of evasion of KRAS G12C inhibitor efficacy. Out of those five KRAS amplification cases, four experienced tumor shrinkage, three showed a clinical response, and the disease control rate was 100%, indicating elisrasib’s effectiveness in this biomarker-defined group."

Additional D3 Bio Presentations at AACR (Free AACR Whitepaper) 2026

D3 Bio also presented advancements in its KRAS program, notably:

First-in-human phase 1 investigation of D3S-002, a selective ERK1/2 inhibitor, in advanced solid tumors with MAPK pathway mutations — Poster (Abstract CT060)
Clinical pharmacokinetic modeling of D3S-003, an oral dual-state KRAS G12D inhibitor — Poster (Abstract 1831)
D3S-003: An allele-specific, orally available KRAS G12D (OFF/ON) inhibitor with best-in-class potential — Poster (Abstract 4569)
"We are encouraged by the consistent and robust clinical activity exhibited by elisrasib across various KRAS G12C–mutant tumors, reinforcing the strength and momentum of D3 Bio’s expanding KRAS pipeline," commented Dr. George Chen, Founder, Chairman and Chief Executive Officer of D3 Bio. "These data suggest elisrasib may become a foundational therapy for KRAS G12C mutant cancers."

About Elisrasib (D3S-001)

Elisrasib is a next-generation KRAS G12C inhibitor designed for rapid, complete, and selective target engagement. It covalently binds the GDP-bound (OFF) form of KRAS G12C, effectively blocking nucleotide cycling and suppressing oncogenic signaling. Preclinical studies show robust potency, complete KRAS G12C engagement at clinically relevant exposures, and CNS penetration capability. Elisrasib is currently being evaluated globally in a Phase 2 monotherapy and combination trial across KRAS G12C–mutant solid tumors including NSCLC, CRC, and others.

Key Publications:

Cancer Discovery

Nature Medicine (2025) 31(8):2768–2777

About D3S-002

D3S‑002 is a selective ERK1/2 inhibitor purposely designed for combination approaches, providing vertical MAPK‑pathway inhibition to enhance efficacy and overcome acquired resistance, particularly in tumors previously treated with KRAS G12C inhibitors.

Key Publication:

Cancer Res 1 April 2023; 83 (7_Supplement): 5501.

About D3S-003

D3S‑003 is a differentiated KRAS G12D inhibitor targeting both active (ON) and inactive (OFF) conformations, addressing one of the most common KRAS mutations. This program expands D3 Bio’s multi-allele KRAS portfolio, aiming to provide innovative therapies for diverse KRAS-driven malignancies.

(Press release, D3 Bio, APR 29, 2026, View Source [SID1234664908])

Immutep Quarterly Activities Report & Appendix 4C Q3 FY26

On April 29, 2026 Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep" or "the Company"), a clinical-stage biotechnology company targeting cancer and autoimmune diseases, reported an update on its activities for the quarter ended 31 March 2026 (Q3 FY26).

LUNG CANCER

TACTI-004 (KEYNOTE-F91) – Phase III Trial in 1L NSCLC

In March 2026, Immutep announced that the Independent Data Monitoring Committee (IDMC) for the TACTI-004 Phase III study evaluating eftilagimod alfa ("efti") in patients in first-line non-small cell lung cancer (1L NSCLC) had recommended the discontinuation of the trial following a planned interim futility analysis in accordance with the study protocol.

The futility analysis was based on data from approximately 170 patients and included a review of baseline disease characteristics, safety, and overall response rate ("ORR").

After carefully considering the recommendation of the IDMC, as well as conducting its own internal review of the data, Immutep has followed the IDMC’s recommendation and decided to discontinue TACTI-004. Notably, Immutep’s review included additional data such as early interim progression-free survival data.

More specifically, the Company decided that it was necessary to discontinue TACTI-004 because patients receiving a combination of efti, KEYTRUDA and chemotherapy (the "efti arm") were underperforming relative to patients receiving a combination of placebo, KEYTRUDA and chemotherapy (the "control arm"). This outcome was unexpected, given that efti combined with standard of care has typically produced higher response rates when compared to historical studies or controls. In particular, this outcome was notably inferior to results observed in INSIGHT-003 which was testing the same combinations in nonsquamous 1L NSCLC patients.

In response to the IDMC’s recommendation, enrolment in TACTI-004 has been halted and Immutep is implementing an orderly wind-down of the study, including appropriate patient follow-up and site close-out in accordance with regulatory and ethical obligations.

While this is a disappointing outcome, it is important to note that this decision relates specifically to TACTI-004 and does not necessarily mean that efti as a broader development program will be discontinued.

Immutep is conducting a thorough review of available data to understand factors behind the futility outcome, examining clinical, operational, analytical, and manufacturing aspects. The process includes collecting and analysing patient samples from TACTI-004 across up to 150 sites and relevant data cleaning. This root cause analysis may extend into Q3 CY2026, depending on data availability and logistics, covering database lock, statistical analysis, and laboratory data review.

Dr. Reddy’s Laboratories Ltd. ("Dr. Reddy’s"), a key licensing partner for Immutep’s efti, continues to demonstrate support and provide technical expertise to assist with the completion of the root cause analysis.

"We continue to work collaboratively with Immutep on the ongoing evaluation of eftilagimod alfa, with a shared focus on determining the appropriate path forward" stated M.V. Ramana, CEO – Global Generics, Dr. Reddy’s.

INSIGHT-003 – Phase I Trial in Non-Squamous 1L NSCLC

Patients in the investigator-initiated INSIGHT-003 trial, in which dosing had been completed, continue to be followed up.

In this study, the combination of efti with KEYTRUDA and chemotherapy has generated strong objective response rates (ORR) and disease control rates (DCR) in 51 evaluable patients with advanced or metastatic non-squamous 1L NSCLC across all PD-L1 expression levels.

SOFT TISSUE SARCOMA

EFTISARC-NEO – Phase II Trial in Soft Tissue Sarcoma

The investigator-initiated EFTISARC-NEO Phase II trial was evaluating efti with radiotherapy plus KEYTRUDA in the neoadjuvant setting for resectable soft tissue sarcoma (STS).

The study met its primary objective and patients show a strong immune system activation in line with efti’s mode of action, with statistically significant increases in the expression of key cytokines and chemokines in peripheral blood — specifically CXCL9, CXCL10, IL-23, and IFN-γ.2,3 Dosing is completed, and patients are being followed up for disease free survival.

In April 2026, Immutep announced that it had received an orphan drug designation for efti in this setting from the FDA.

Breast Cancer

AIPAC-003 – Phase II Trial in Metastatic Breast Cancer

Immutep continues to follow up patients in the AIPAC-003 Phase II trial which is evaluating efti in combination with chemotherapy in hormone receptor positive (HR+), HER2- negative/low metastatic breast cancer resistant to endocrine-based therapy or metastatic triple-negative breast cancer not eligible for PD-(L)1-based therapy.

Patients were randomised 1:1 (N=66) to receive either 30 mg or 90 mg efti in combination with chemotherapy to determine the optimal biological dose (OBD) of efti consistent with the FDA’s Project Optimus initiative. Dosing is complete, and patients are being followed up for overall survival.

Investigator-Initiated Phase II Trial for Neoadjuvant Efti in HR+/HER2-negative Breast Cancer

A proposed investigator-initiated Phase II trial evaluating neoadjuvant efti as monotherapy and in combination with chemotherapy prior to surgery in early-stage HR+/HER2-negative breast cancer patients is on hold and subject to the root cause analysis related to TACTI004.

IMP761 DEVELOPMENT PROGRAM FOR AUTOIMMUNE DISEASE

IMP761 – Phase I Trial

In March 2026, Immutep announced an update from the placebo-controlled, double-blind first-in-human Phase I study in healthy participants evaluating IMP761, a first-in-class LAG-3 agonist antibody for autoimmune diseases. The single ascending portion of the Phase I trial has now been completed, with dosing up to 14 mg/kg and no safety concerns observed. The study is now continuing in the multiple ascending dose (MAD) phase, which is evaluating pharmacokinetics and safety at two dose levels, with completion expected in 3Q CY2026. The Company will present details on IMP761 at the upcoming EULAR 2026 Congress, which will be held in London, from 3–6 June 2026 and plans to release additional data in 2H CY2026.

INTELLECTUAL PROPERTY

During the quarter, Immutep was granted a new patent in Mexico directed to an assay for use in measuring the potency of IMP761 as part of a quality control step in production of the agonist LAG-3 antibody.

A new Japanese patent was also granted during the quarter directed to LAG525. The patent is co-owned by Immutep S.A.S. and Novartis AG and exclusively licensed to Novartis AG.

FINANCIAL SUMMARY

During the quarter, Immutep continued to exercise prudent cash management, particularly in light of the TACTI-004 Phase III discontinuation.

The Company is well funded with a cash and cash equivalent, and term deposit balance as at 31 March 2026 of approximately A$110.6 million, which is better than the FY2026 budget. However, this cash balance will be reduced by the wind down costs of TACTI-004 and associated activities.

The total balance consists of 1) a cash and cash equivalent balance of A$84.3 million and 2) bank term deposits totaling A$26.3 million, which have been recognised as short-term investments due to having maturities of more than 3 months and less than 12 months.

In Q3 FY26, cash receipts from customers were A$28.85 million, which is mainly due to the US$20 million (~A$28.84 million4 ) upfront payment from Dr. Reddy’s. The net cash used in G&A activities in the quarter was A$0.9 million compared to A$1.3 million in Q2 FY26.

In respect of the upfront licence fee of US$20 million received from Dr. Reddy’s in January 2026, US$2.7million (A$4.1 million5 ) was recognised as revenue and US$17.3 million (A$25.8 million6 ) was recognised as unearned revenue in the Company’s Half Year Financial Report for the period ended 31 December 2025. Following the discontinuation of TACTI‑004, a payment obligation has arisen under the Company’s licence agreement with Dr. Reddy’s. Under the licence agreement terms, the Company must pay US$10 million to Dr. Reddy’s by June 2026 in these circumstances. No payment has been made to Dr. Reddy’s at the date of this announcement. The expected payment will result in a cash outflow of US$10 million in the June 2026 quarter and corresponding reduction in unearned revenue. The remaining balance of US$7.3 million in unearned revenue is expected to be recognised as revenue for the half-year ending 30 June 2026.

As previously disclosed, under the terms of the licensing agreement, Dr. Reddy’s has the exclusive rights to develop and commercialise efti in the licensed territories; Immutep has an entitlement to potential regulatory, development and commercial milestone payments of up to US$349.5 million; royalties on commercial sales in the licensed territories; and Immutep retains global manufacturing rights and will supply the product to Dr. Reddy’s in the licensed markets.

The cash used in R&D activities during the quarter was A$11.8 million, compared to A$9.9 million in Q2 FY26. Payment for staff costs was A$2.6 million in the quarter, remaining the same level as in Q2 FY26. Total net cash inflows from operating activities in the quarter were A$13.5 million compared to net cash outflow of A$9.4 million in Q2 FY26.

Payments to Related Parties (detailed in item 6.1 of the Appendix 4C) comprises NonExecutive Directors’ fees and Executive Directors’ remuneration of A$515k.

Total net cash inflow received in investing activities for the quarter was A$20k, which is mainly the refund of an office security deposit.

After the TACTI-004 Phase III futility outcome, the Company has started to initiate cost reduction measures to preserve capital and extend its cash runway. These measures include a targeted reduction in headcount and other operating expense reductions. The discontinuation of TACTI-004 also precipitates a reduction in cash outlays due to the trial activity being wound down. At the time of preparing this report, the Company expects its cash runway to extend into H1 of CY28.

(Press release, Immutep, APR 29, 2026, View Source;v=undefined [SID1234664907])

U.S. FDA Grants Priority Review to BeOne Medicines’ TEVIMBRA in First-Line HER2+ GEA

On April 29, 2026 BeOne Medicines Ltd. (Nasdaq: ONC; HKEX: 06160; SSE: 688235), a global oncology company, reported that the U.S. Food and Drug Administration (FDA) has granted Priority Review to a supplemental Biologics License Application (sBLA) for TEVIMBRA (tislelizumab) in combination with ZIIHERA (zanidatamab) and chemotherapy for the first-line treatment of unresectable locally advanced/metastatic HER2-positive (HER2) gastric, gastroesophageal junction, or esophageal adenocarcinoma. The FDA has also granted Breakthrough Therapy Designation to the regimen of ZIIHERA in combination with fluoropyrimidine- and platinum-containing chemotherapy, with and without TEVIMBRA, in this indication.

Mark Lanasa, M.D., Ph.D., Chief Medical Officer, Solid Tumors, BeOne Medicines, said:

"HERIZON‑GEA‑01 has the potential to shift the treatment paradigm in this historically difficult-to-treat disease, with the TEVIMBRA-containing arm demonstrating an unprecedented 26-month survival benefit. The FDA’s Priority Review designation is a major milestone in our effort to bring better first‑line options to patients with HER2‑positive gastroesophageal adenocarcinoma. We will work in partnership with regulators to support the review process, with the aim of rapidly bringing this new treatment option to patients."

Data supporting sBLA filing

The sBLA submission is based on the first interim analysis (IA1) of HERIZON-GEA-01, a global Phase 3 clinical trial designed to evaluate ZIIHERA plus chemotherapy, with and without TEVIMBRA, compared with the control arm of trastuzumab plus chemotherapy as first-line treatment for advanced/metastatic HER2+ GEA. Key findings of the trial include:

Overall survival (OS): The arm in which TEVIMBRA was added to ZIIHERA and chemotherapy resulted in a statistically significant improvement in OS (median OS of 26.4 months) at IA1. The ZIIHERA plus chemotherapy arm achieved a median OS of 24.4 months and the control arm resulted in a median OS of 19.2 months.
Progression-free survival (PFS): Both ZIIHERA-containing arms delivered a statistically significant and clinically meaningful improvement in median PFS of 12.4 months compared with 8.1 months in the control arm.
Improvement in OS and PFS was observed regardless of PD-L1 status.
The safety findings for the ZIIHERA plus TEVIMBRA and chemotherapy arm were generally consistent with the known effects of the components of the combination regimen, and no new safety signals were identified.
Project Orbis pathway

BeOne plans to participate in the FDA’s Project Orbis, an initiative that provides a framework for collaborative review of oncology products among international partners, for the submission of the HERIZON-GEA-01 data in territories in which BeOne holds the ZIIHERA license. With this pathway, BeOne aims to accelerate approval and patient access to this treatment, recognizing the global significance of the HERIZON‑GEA‑01 results, which demonstrated meaningful survival improvements in a disease where outcomes have remained largely unchanged for more than a decade.

About the HERIZON-GEA-01 Phase 3 Trial

HERIZON-GEA-01 (NCT05152147) is a global, randomized, open-label Phase 3 trial, conducted jointly with Jazz Pharmaceuticals, to evaluate and compare the efficacy and safety of ZIIHERA plus chemotherapy, with and without TEVIMBRA, to the standard of care (trastuzumab plus chemotherapy) as first-line treatment for adult patients with advanced/metastatic HER2+ GEA. The trial randomized 914 patients from approximately 300 trial sites in more than 30 countries. Patients for this trial had unresectable locally advanced, recurrent or metastatic HER2+ GEA (adenocarcinomas of the stomach or esophagus, including the gastroesophageal junction), defined as 3+ HER2 expression by IHC or 2+ HER2 expression by IHC with ISH positivity per central assessment. Patients were randomized to the three trial arms: ZIIHERA in combination with chemotherapy and TEVIMBRA; ZIIHERA in combination with chemotherapy; and trastuzumab plus chemotherapy. The trial is evaluating dual primary endpoints, PFS per blinded independent central review (BICR) and OS.

About Gastroesophageal Adenocarcinoma

Gastroesophageal adenocarcinoma (GEA), which includes cancers of the stomach, gastroesophageal junction, and esophagus, is the fifth most common cancer worldwide. Approximately 20% of GEA patients have HER2-positive disease1,2,3, which has high morbidity and mortality, and patients are urgently in need of new treatment options. The overall prognosis for patients with GEA remains poor, with a global five-year survival rate of less than 30% for gastric cancer and about 19% for GEA.4

About ZIIHERA (zanidatamab)

ZIIHERA (zanidatamab) is a bispecific human epidermal growth factor receptor 2, or HER2-directed antibody that binds to two extracellular sites on HER2. Binding of zanidatamab with HER2 results in internalization leading to a reduction in HER2 expression of the receptor on the tumor cell surface. Zanidatamab induces complement-dependent cytotoxicity (CDC), antibody-dependent cellular cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP). These mechanisms result in tumor growth inhibition and cell death in vitro and in vivo.5

Zanidatamab is being developed in multiple clinical trials as a targeted treatment option for patients with solid tumors that express HER2. Zanidatamab is approved in China for the treatment of patients who have unresectable, locally advanced, or metastatic HER2-high expression (IHC 3+) biliary tract cancer (BTC) and who have received prior systemic therapy. ZIIHERA has also been granted accelerated approval in the U.S. and conditional marketing authorization in the European Union for eligible BTC patients. Zanidatamab is being developed by Jazz and BeOne under license agreements from Zymeworks, which first developed the molecule. BeOne has licensed zanidatamab from Zymeworks in Asia (excluding India and Japan), Australia and New Zealand. Jazz Pharmaceuticals has rights in all other regions.

ZIIHERA is a registered trademark of Zymeworks BC Inc.

About TEVIMBRA (tislelizumab)

TEVIMBRA is a uniquely designed humanized immunoglobulin G4 (IgG4) anti-programmed cell death protein 1 (PD-1) monoclonal antibody with high affinity and binding specificity against PD-1. It is designed to minimize binding to Fc-gamma (Fcγ) receptors on macrophages, helping to aid the body’s immune cells to detect and fight tumors.

TEVIMBRA is the foundational asset of BeOne’s solid tumor portfolio and has shown potential across multiple tumor types and disease settings. The global TEVIMBRA clinical development program includes more than 15,000 patients enrolled to date in 30+ countries and regions across 72 trials, including 22 registration-enabling studies. TEVIMBRA is approved in 50 countries, and more than 1.9 million patients have been treated globally.

Select Important Safety Information

Serious and sometimes fatal adverse reactions occurred with TEVIMBRA treatment. Warnings and precautions include severe and fatal immune-mediated adverse reactions, including pneumonitis, colitis, hepatitis, endocrinopathies, dermatologic adverse reactions, nephritis with renal dysfunction, and solid organ transplant rejection. Other warnings and precautions include infusion-related reactions, complications of allogeneic HSCT, and embryo-fetal toxicity.

Please see full U.S. Prescribing Information including the U.S. Medication Guide.

The information in this press release is intended for a global audience. Product indications vary by region.

(Press release, BeOne Medicines, APR 29, 2026, View Source [SID1234664906])

Biogen reports strong first quarter 2026 results

On April 29, 2026 Biogen Inc. (Nasdaq: BIIB) reported first quarter 2026 financial results. Commenting on the quarter, President and Chief Executive Officer Christopher A. Viehbacher said:

"We significantly advanced our transformation into the New Biogen through strong commercial and pipeline execution and the announcement of our intent to acquire Apellis. We believe the planned acquisition of Apellis will bolster our revenue and earnings growth, adding two differentiated commercial medicines and deepening the foundation for felzartamab, our key Phase 3 asset in kidney disease. This acquisition and the acquired rights to felzartamab in China come while we also expanded sales of our growth products, demonstrated continued resilience in our MS portfolio and reported important positive new data that reinforce our confidence in the late‑stage pipeline."
Financial Highlights
Q1 ’26 Q1 ’25 △
r (CC*)
Total Revenue (in millions) $2,478 $2,431 2% (2)%
GAAP diluted EPS $2.15 $1.64 31% N/A
Non-GAAP diluted EPS $3.57 $3.02 18% N/A

Note: Percent changes represented as favorable/(unfavorable) versus the prior year period.
N/A = not applicable.
* Percentage changes in revenue growth at constant currency (CC) are presented excluding the impact of changes in foreign currency exchange rates and hedging gains or losses. Foreign currency revenue values are converted into U.S. Dollars using the exchange rates from the end of the previous calendar year.

A reconciliation of GAAP to Non-GAAP financial measures can be found in Table 4 at the end of this news release.
Revenue Summary
(in millions) Q1 ’26 Q1 ’25 △
r (CC*)
Multiple sclerosis (MS) product revenue(1)
$958 $953 —% (3)%
Rare disease revenue(2)
$557 $563 (1)% (5)%
Biosimilars revenue $182 $181 1% (7)%
Other product revenue(3)
$55 $29 88% 87%
Total product revenue $1,752 $1,727 1% (3)%
Revenue from anti-CD20 therapeutic programs $419 $378 11% 11%
Alzheimer’s collaboration revenue(4)
$60 $33 80% 80%
Contract manufacturing, royalty and other revenue $247 $293 (16)% (20)%
Total revenue $2,478 $2,431 2% (2)%

Note: Percent changes represented as favorable/(unfavorable) versus the prior year period. Numbers may not foot or recalculate due to rounding.
(1) Multiple sclerosis includes TECFIDERA, VUMERITY, AVONEX, PLEGRIDY and TYSABRI.
(2) Rare disease includes SPINRAZA, SKYCLARYS and QALSODY.
(3) Other includes ADUHELM, FUMADERM and ZURZUVAE.
(4) Includes Biogen’s 50% share of net revenue and cost of sales, including royalties, from the LEQEMBI Collaboration.

•Within MS product revenue TYSABRI benefitted from approximately $40 million from a favorable adjustment to discounts and allowances and inventory timing in the U.S. and $19 million of favorable inventory timing outside the U.S.

•Contract manufacturing, royalty and other revenue benefitted from the acceleration of manufacturing activity in the first quarter.

Expense Summary
(in millions) Q1 ’26 Q1 ’25 △
GAAP cost of sales*
$661 $629 (5)%
% of Total Revenue 27% 26%
Non-GAAP cost of sales*
$610 $580 (5)%
% of Total Revenue 25% 24%
GAAP R&D expense $539 $434 (24)%
Non-GAAP R&D expense $480 $427 (13)%
GAAP SG&A expense $607 $573 (6)%
Non-GAAP SG&A expense $600 $572 (5)%
GAAP and Non-GAAP acquired IPR&D, upfront and milestone expense $34 $201 NMF

Note: Percent changes represented as favorable/(unfavorable) versus the prior year period
IPR&D = in-process R&D; NMF = no meaningful figure.
* Excluding amortization and impairment of acquired intangible assets

•The increase in first quarter 2026 GAAP and Non-GAAP cost of sales as a percentage of total revenue was driven primarily by product mix.

•The increase in first quarter 2026 GAAP R&D expense was primarily driven by approximately $57 million of step-up amortization related to SKYCLARYS inventory as well as increased investment in late-stage programs including litifilimab and felzartamab. The increase in first quarter 2026 Non-GAAP R&D expense was primarily driven by increased investment in late-stage programs including litifilimab and felzartamab.

•The increase in first quarter 2026 GAAP and Non-GAAP SG&A was primarily driven by investments to support product launches.

•First quarter 2026 GAAP and Non-GAAP acquired IPR&D, upfront and milestone expense was $34 million.
Other Financial Highlights

•First quarter 2026 GAAP and Non-GAAP collaboration profit sharing was a net expense of approximately $74 million, which includes approximately $57 million related to Biogen’s collaboration with Samsung Bioepis, and approximately $17 million related to Biogen’s collaboration with Supernus Pharmaceuticals, Inc. for the commercialization of ZURZUVAE in the U.S.

•First quarter 2026 GAAP other expense was approximately $20 million driven by net interest expense partially offset by net unrealized gains on equity securities. First quarter 2026 Non-GAAP other expense was approximately $42 million primarily driven by net interest expense.

•First quarter 2026 GAAP and Non-GAAP effective tax rates were 15.4% and 15.3%, respectively. First quarter 2025 GAAP and Non-GAAP effective tax rates were 22.7% and 19.4%, respectively. The year over year decrease in the Non-GAAP effective tax rate was due to favorable impacts from a foreign tax settlement and vesting of certain share-based awards partly offset by the increase in U.S. taxation on foreign earnings in 2026 under the One Big Beautiful Bill Act.

Financial Position

•First quarter 2026 net cash flow from operations was approximately $646 million. Capital expenditures were approximately $51 million, and free cash flow, a Non-GAAP financial measure defined as net cash flow from operations less capital expenditures, was approximately $594 million.

•As of March 31, 2026, Biogen had cash and cash equivalents totaling approximately $4.7 billion and approximately $6.3 billion in total debt, resulting in net debt of approximately $1.5 billion.

•For the first quarter of 2026 the Company’s weighted average diluted shares were approximately 148 million.
Full Year 2026 Financial Guidance

Biogen is updating its guidance for full year 2026 to reflect an approximately $1.00 impact from acquired IPR&D charges resulting from ongoing business development activities to support Biogen’s growth strategy. This comprises approximately $0.20 recorded in the first quarter and approximately $0.80 expected in the second quarter. This updated guidance excludes the anticipated Apellis transaction. Full year 2026 Non-GAAP diluted EPS range is expected as follows:
Full Year 2026 Non-GAAP Diluted EPS
Prior Guidance (February 2026) $15.25 to $16.25
Approx. impact from acquired IPR&D charges recorded in Q1 and expected in Q2 2026*
(Excluding the Apellis transaction)
($1.00)
Updated Guidance $14.25 to $15.25

*Includes an expected approximately $0.55 Non-GAAP diluted EPS impact from the deal with TJ Biopharma for felzartamab Greater China region rights and an additional $0.25 Non-GAAP diluted EPS impact from a milestone expected to occur in the second quarter of 2026.

Total revenue is expected to decline by a mid-single digit percentage for 2026 as compared to 2025 as further declines in multiple sclerosis product revenue, excluding VUMERITY, are expected to be partially offset by increases in revenue from growth products.

For full year 2026 as compared to full year 2025, Biogen expects the gross margin percentage, and combined Non-GAAP R&D expense and Non-GAAP SG&A expense to be roughly consistent year-over-year. Biogen expects full year 2026 Non-GAAP effective tax rate to be between approximately 17% and 18%.

This guidance also assumes that foreign exchange rates as of April 24, 2026, will remain in effect for the remainder of the year, net of hedging activities.

Other than the acquired IPR&D impact expressly stated above, this financial guidance does not include any other potential future acquired IPR&D charges, impact from potential acquisitions or business development transactions or pending and future litigation or any impact of potential healthcare reform, as all are difficult to predict. Other important financial considerations will be provided on the conference call and webcast.

Biogen may incur charges, realize gains or losses, or experience other events or circumstances in 2026 that could cause any of these assumptions and expectations to change and/or actual results to vary from this financial guidance.

Biogen does not provide guidance for GAAP reported financial measures (other than revenue) or a reconciliation of forward-looking Non-GAAP financial measures to the most directly comparable GAAP reported financial measures because the Company is unable without unreasonable effort to predict with reasonable certainty the financial impact of items such as the transaction, integration, and certain other costs related to acquisitions or large business development transactions; unusual gains and losses; potential future asset impairments; gains and losses from equity security investments; and the ultimate outcome of pending or future litigation. These items are uncertain, depend on various factors, and could have a material impact on GAAP reported results for the guidance period. For the same reasons, the Company is unable to address the significance of the unavailable information, which could be material to future results.

Conference Call and Webcast

The Company’s earnings conference call for the first quarter will be broadcast via the internet at 8:00 a.m. ET on April 29, 2026 and will be accessible through the Investors section of Biogen’s website, www.biogen.com. Supplemental information in the form of a slide presentation is also accessible at the same location on the internet and will be subsequently available on the website for at least 90 days.

(Press release, Biogen, APR 29, 2026, View Source [SID1234664903])

Transgene Provides Business and Financial Update for Q1 2026

On April 29, 2026 Transgene (Euronext Paris: TNG), a biotech company that designs and develops virus-based immunotherapies for the treatment of cancer, reported a business update on its myvac platform, and its individualized neoantigen therapeutic vaccine (INTV) TG4050, and upcoming plans, including its financial position as of March 31, 2026.

TG4050, Transgene’s first INTV from its myvac platform continues to progress according to plan in the adjuvant treatment of head and neck cancer

TG4050 is designed to stimulate a strong and individualized immune response aimed at preventing relapse in HPV-negative head and neck cancer (HNSCC1) patients following surgery and adjuvant (chemo)radiotherapy. It is currently under evaluation in a randomized multicenter Phase 1/2 clinical trial (NCT04183166).

As a monotherapy, TG4050 met all trial endpoints in the Phase 1 part of the trial and induced long-lasting immune responses to individualized vaccine neoantigens that were sustained for up to two years after treatment initiation. All patients treated were disease-free at 2 years, providing robust clinical proof of principle.

A comprehensive analysis of these positive clinical and translational data from the Phase 1 part of the randomized Phase 1/2 trial of TG4050 was published on the preprint platform medRxiv, in January 2026 (see press release). The data suggest that individualized treatment with TG4050 has the potential to prevent cancer relapses. The article is under review by a peer-reviewed journal. These data have also been presented orally at the World Vaccine Congress (WVC) (see press release).

3-year disease-free survival (DFS) follow-up of Phase 1 patients is expected in Q2/Q3 2026.
Transgene announced that the randomization of the Phase 2 part of the Phase 1/2 trial for adjuvant treatment of HNSCC has been completed (see press release).

The primary endpoint of the trial is 2-year DFS. Transgene expects to communicate these top-line results by the end of Q1 2028.
Early April 2026, Transgene and NEC Bio signed a license agreement to advance the clinical development of TG4050 in head and neck cancer (see press release). Transgene secures access to NEC’s AI-based neoantigen prediction platform, as well as rights to enable TG4050’s further clinical development and to support commercialization and potential partnering of the program. Under this agreement, Transgene has paid a technology access fee of €2.5 million in Transgene shares as well as a first tranche of €0.5 million from a total payment of a total €2.5 million in cash that will be paid out in several instalments through early 2028. Additional development and milestone payments will be paid upon progress of the clinical development of TG4050 in head and neck cancer.

Expanding the value of the myvac platform

Transgene’s INTV platform, myvac, has the potential to generate INTVs that could be used to improve treatment across a range of solid tumors where in many cases a significant unmet medical need remains.

In parallel with the ongoing Phase 1/2 trial in HNSCC, Transgene is progressing with start-up activities for a new Phase 1 trial in a second indication in an early treatment setting, with the aim of initiating later in 2026, as soon as all conditions are met.
To further enhance value and unlock the full potential of the myvac platform, Transgene continues to invest in the optimization of the manufacturing of its INTV candidates, with the aim of reducing turnaround time, enabling scalability and increasing capacity.

Operating revenue and financial visibility

During the first quarter of 2026, operating revenue amounted to €1.4 million compared to €2.5 million for the same period in 2025. It mostly comprised the research tax credit of €1.1 million compared to €2.3 million for the same period in 2025. In Q1 2025, eligible activities against which research tax credit could be claimed comprised manufacturing for the patients in the Phase 2 part of the TG4050 trial in HNSCC; most of these manufacturing activities were completed in Q1 2026, explaining the decrease of the RTC.

As of March 31, 2026, Transgene had €103.8 million in cash, cash equivalents and other financial assets, compared to €111.9 million as of December 31, 2025. Over the first quarter of 2026, Transgene’s net cash burn2 was €8.1 million compared to €14.8 million for the same period in 2025.

Under current plans, the company has sufficient cash to ensure financial visibility until early 2028.

(Press release, Transgene, APR 29, 2026, View Source [SID1234664900])