On May 13, 2026 Acrivon Therapeutics, Inc. ("Acrivon" or "Acrivon Therapeutics") (Nasdaq: ACRV), a clinical stage biotechnology company discovering and developing precision medicines utilizing its proprietary Generative Phosphoproteomics AP3 (Acrivon Predictive Precision Proteomics) platform deployed for rational drug design and predictive clinical development, reported financial results for the first quarter ended March 31, 2026 and reviewed recent business highlights.

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"2026 is an important catalyst year for Acrivon as we advance our two differentiated, AP3-guided clinical oncology programs towards key data read-outs," said Peter Blume-Jensen, M.D., Ph.D., chief executive officer, president and co-founder of Acrivon. "For ACR-368, we are increasingly focused on serous endometrial cancer, a disease with high unmet need contributing upwards of 50% of all endometrial cancer deaths every year. This focus is supported by the compelling clinical activity observed thus far and the enthusiastic endorsement by external KOLs. We are particularly excited by the prospect of rapid enrollment of the serous population in our Phase 2b study in the U.S. and EU given that there is no requirement for a biopsy. Given the accelerated enrollment, we are now planning to conduct a pre-specified simultaneous interim analysis of both Arms 3 and 4 in second half of 2026. In parallel, we continue advancing ACR-2316 which has shown exciting initial clinical activity in AP3-prioritized tumor types, including lung cancers which are traditionally not sensitive to WEE1 inhibitors. With cash runway expected into the third quarter of 2027, we believe we are well positioned to execute through multiple potential value-inflection milestones."

Recent Highlights

ACR-368: CHK1 / CHK2 Inhibitor

Recently presented interim analysis of the ongoing, multi-arm, registrational intent Phase 2b study across both OncoSignature-positive (BM+) and BM- endometrial cancer (EC) subjects showed a confirmed overall response rate (cORR) of 52% (N = 23) in serous EC subjects versus an ORR of 22% (N = 37) in non-serous EC subjects, with all subjects having received up to two prior lines of therapy (LoT), including chemotherapy and anti-PD-1. This is consistent with the higher BM positivity rate and elevated biomarker levels in subjects with serous versus non-serous EC.
Arm 1 is ongoing and is stratifying for treatment of EC based on BM+ predicted sensitivity to ACR-368
Arm 2 was successfully completed, showing that ultra-low dose gemcitabine (ULDG) may contribute to ACR-368 efficacy, while maintaining a favorable tolerability profile, in BM- subjects
Arm 3 is investigating ACR-368 with ULDG sensitization in serous EC subjects with up to two prior LoT without the need for pre-treatment tumor biopsy or biomarker stratification ("serous all comer")
Arm 4 enrollment and dosing was recently initiated, investigating single agent ACR-368 without ULDG, in the same "serous all comer" subject population as Arm 3
Clinical data from the Phase 2b trial was featured in a late-breaking oral presentation by Professor Panagiotis Konstantinopoulos of the Dana-Farber Cancer Institute at the European Society of Gynecological Oncology (ESGO) Annual Congress, followed by a company-hosted KOL panel, during which renowned experts expressed strong enthusiasm for the data on ACR-368 and reiterated the high unmet need for patients suffering from serous EC
Two presentations at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting uncovered the underlying molecular mechanisms for potent synergies between ACR-368 and anti-PD-L1 checkpoint inhibitors or Topoisomerase 1 (Topo 1) inhibitors identified by AP3. These findings support potential clinical combination studies with antibody-drug conjugates (ADCs) or immune checkpoint inhibitors (ICIs), including a planned Phase 3 confirmatory study of ACR-368 with ICIs.

ACR-2316: WEE1 / PKMYT1 Inhibitor

Initial data from the Phase 1 monotherapy dose-escalation trial demonstrated a favorable safety profile, primarily limited to only transient neutropenia and notable absence of non-hematological adverse events, and demonstrated clinical activity with both tumor shrinkage as well as prolonged clinical benefit, notably including partial responses and strong disease control in small cell lung cancer (SCLC) and squamous non-small cell lung cancer (NSCLC), tumor types predicted sensitive by AP3 not previously shown sensitive to WEE1 or PKMYT1 inhibitors in development
AP3-based data presented at the AACR (Free AACR Whitepaper) Annual Meeting demonstrated the processes driving strong synergy and resulting in complete tumor regression with durable immune memory upon treatment with ACR-2316 and ICI. ACR-2316 was found to boost immune-mediated tumor killing and overcome anti-PD-L1 resistance by modulating T-cell exhaustion, providing a mechanistic rationale for potential combinations with ICIs.

CDK11 Inhibitor Program

Internally-discovered development candidate from company’s AP3-driven cell cycle program and several equally promising back-up lead compounds being advanced in Investigational New Drug (IND)-enabling studies.

Anticipated Upcoming Milestones

ACR-368 Ongoing Registrational Intent Phase 2b Study

A prespecified simultaneous interim analysis and data update from both all-comer (biopsy-independent) serous EC arms of the ACR-368 Phase 2b study in second half of 2026
Achieve readiness for Phase 3 confirmatory trial for ACR-368 in combination with PD-1 therapy by mid-2026
Based on interim data read-out, complete enrollment of the registrational intent all-comer (biopsy-independent) serous EC Arm 3 or Arm 4 by fourth quarter of 2026

Broader Pipeline

Additional ACR-2316 Phase 1/2 clinical data for weekly and bi-weekly dosing regimens and transition into dose expansion in AP3-identified tumor types in 2026
Submit IND filing to the FDA for ACR-6840, or alternative CDK11 inhibitor candidate, in first half of 2027
Initiate additional internal programs utilizing the AP3 platform in 2026

First Quarter 2026 Financial Results

Net loss for the quarter ended March 31, 2026 was $19.0 million compared to a net loss of $19.7 million for the same period in 2025.

Research and development expenses were $15.2 million for the quarter ended March 31, 2026 compared to $15.4 million for the same period in 2025, which is materially consistent.

General and administrative expenses were $4.7 million for the quarter ended March 31, 2026, compared to $6.2 million for the same period in 2025. The difference was primarily due to a decrease in employee-related expenses including stock-based compensation.

As of March 31, 2026, the company had cash, cash equivalents and investments of $97.7 million which, together with the net proceeds raised from subsequent equity financing, is expected to fund operating expenses and capital expenditure requirements into the third quarter of 2027.

(Press release, Acrivon Therapeutics, MAY 13, 2026, View Source [SID1234665657])

On May 13, 2026 Innate Pharma SA (Euronext Paris: IPH; Nasdaq: IPHA) ("Innate" or the "Company") reported its business update and consolidated financial results for the quarter ending March 31, 2026.

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"We have continued to make solid progress across our priority clinical assets during the first quarter. We are approaching completion of enrollment in the Phase 1 dose escalation and backfill cohorts for IPH4502. In parallel, we have advanced the negotiations for non-dilutive financing options to allow initiation of the lacutamab confirmatory Phase 3 TELLOMAK-3 trial in CTCL. Finally, the Phase 3 PACIFIC-9 trial with AstraZeneca is planned for data readout in the second half of 2026. Separately, we were pleased to see encouraging results from the MATISSE Phase 2 trial presented at the AACR (Free AACR Whitepaper) Annual Meeting 2026. It is exciting to see the continued advancement of our differentiated immunotherapy pipeline for patients with high unmet medical need," said Jonathan Dickinson, Chief Executive Officer of Innate Pharma.

Webcast and conference call will be held today at 1:30 p.m. CEST (7:30 a.m. EDT)

Click here to access the live webcast.

Analysts may also join via telephone to ask questions, click here to register.

This information can also be found on the Investors section of the Innate Pharma website, www.innate-pharma.com.

A replay of the webcast will be available on the Company’s website for 90 days following the event.

1 Including short term investments (€4.9m) and non-current financial instruments (€10.4m).

Pipeline highlights:

Lacutamab (anti-KIR3DL2 antibody):

Cutaneous T-Cell Lymphoma

The planned confirmatory Phase 3 TELLOMAK-3 trial is an open-label, multi-center, randomized, comparative study evaluating lacutamab in patients with Sézary syndrome and mycosis fungoides, who have failed at least one prior systemic therapy.
TELLOMAK-3 includes two cohorts: a confirmatory cohort in Sézary syndrome, intended to support a potential accelerated approval based on existing TELLOMAK Phase 2 data, and a registrational cohort in mycosis fungoides, intended to support full approval. The primary endpoint of the study for both cohorts is progression-free survival (PFS) evaluated by blinded central review.
Following the U.S. Food and Drug Administration (FDA) review of the Phase 3 protocol, with no further comments in November 2025, the trial is planned for initiation in H2 2026.
The FDA provided encouraging feedback on the TELLOMAK Phase 2 results and the proposed regulatory pathway, which may support an accelerated approval in Sézary syndrome once the Phase 3 trial is underway. In February 2025, the FDA granted Breakthrough Therapy Designation to lacutamab for relapsed or refractory Sézary syndrome.
The TELLOMAK Phase 2 trial is completed, and patients still on treatment at the end of the study continue to receive lacutamab through a Post Trial Access program.
An abstract authored by ZS Associates entitled "Cutaneous T-Cell Lymphoma Epidemiology in the United States: A Real-World Data Analysis of Administrative Claims" has been accepted for publication in the official Abstract Book of the European Hematology Association (EHA) (Free EHA Whitepaper) Congress 2026. The analysis, sponsored by Innate, reports approximately 12,400 prevalent patients with mycosis fungoides (MF) and 1,100 with Sézary syndrome (SS), with ~2,900 and ~300 new cases per year, respectively.
Peripheral T-Cell Lymphoma (PTCL)

KILT (anti-KIR in T-Cell Lymphoma) Phase 2 trial, an investigator-sponsored, randomized study led by the Lymphoma Study Association (LYSA) evaluating lacutamab in combination with GEMOX (gemcitabine and oxaliplatin) versus GEMOX alone in patients with KIR3DL2-expressing relapsed/refractory PTCL, is ongoing.
IPH4502 (Nectin-4 exatecan ADC):

The IPH4502-101 Phase 1 study (NCT06781983), recruiting in France and in the United States, is evaluating the safety, tolerability, and preliminary anti-tumor activity of IPH4502 in advanced solid tumors known to express Nectin-4, including but not limited to urothelial carcinoma, non-small cell lung, breast, ovarian, gastric, esophageal, and colorectal cancers.
The maximum tolerated dose has been reached and enrollment in the Phase 1 dose escalation and cohort enrichment is nearing completion. Preliminary anti-tumor activity continues to be observed in heavily pre-treated patients with advanced solid tumors, including in patients with urothelial cancer relapsed or refractory to enfortumab vedotin, with a favorable safety profile to date.
Monalizumab (anti-NKG2A antibody), developed in collaboration with AstraZeneca:

The PACIFIC-9 Phase 3 trial run by AstraZeneca evaluating durvalumab (anti-PD‑L1) in combination with monalizumab or AstraZeneca’s oleclumab (anti-CD73) in patients with unresectable, Stage III non-small cell lung cancer (NSCLC) who have not progressed following platinum-based chemoradiation therapy (CRT) is ongoing. Enrollment in the trial is complete, and data readout is expected in H2 2026.
Other Clinical stage assets

IPH5201 (anti-CD39 antibody, developed in collaboration with AstraZeneca): The MATISSE Phase 2 trial is evaluating IPH5201 in combination with durvalumab and platinum-based chemotherapy in the neoadjuvant lung cancer setting.

Interim results from MATISSE Phase 2 were presented in a Clinical Trials Plenary Session at the AACR (Free AACR Whitepaper) Annual Meeting 2026 on April 21, 2026 in San Diego, by Pr. Fabrice Barlesi (Institut Gustave Roussy). The pre-planned interim analysis was conducted on 40 patients with resectable early-stage (stage II–IIIA) NSCLC treated with perioperative IPH5201 in combination with durvalumab and platinum-based chemotherapy. The combination showed encouraging results with overall pathological complete response (pCR) rate of 27.5% (95% CI: 14.6–43.9). pCR rates were notably higher in patients with PD-L1-positive tumors, reaching 35.7% in PD-L1 ≥1% patients (n=28%) and 50.0% in PD‑L1 ≥50% patients (n=14). Higher baseline tumor CD39+ and CD8+ cell density was observed in patients achieving pCR/mPR, suggesting CD39 expression as a potentially emerging biomarker. The safety profile was comparable to that of preoperative platinum-based chemotherapy with durvalumab. Based on these encouraging results, the MATISSE study continues enrollment in the PD-L1 ≥1% patient population.
IPH5301 (anti-CD73, proprietary): The investigator-sponsored CHANCES Phase 1 trial of IPH5301 with Institut Paoli-Calmettes is ongoing.

IPH6101 (ANKET anti-CD123, proprietary): Innate has initiated a research collaboration to further assess next steps of development.

IPH6401/SAR’514 (ANKET anti-BCMA, partnered with Sanofi): During the first quarter, Sanofi announced deprioritization of SAR’514, a trifunctional anti-BCMA NK-cell engager. Sanofi retains exclusive development and commercialization rights, and the license terms remain unchanged.

Corporate Update:

As previously announced, in line with its strategic focus, the Company has streamlined its organization. Planned layoffs were implemented through a redundancy plan which is completed.
As of March 31, 2026, the balance available under our April 2023 sales agreement under the At-The-Market program remains at $75 million.
Financial highlights for Q1 2026:

Cash, cash equivalents and financial assets of the Company amounted to €25.4 million as of March 31, 2026. At the same date, financial liabilities amounted to €20.3 million.

Revenue for the three-month period ending March 31, 2026, amounted to €2.6 million (€1.2 million for the same period in 2025). Revenue from collaboration and licensing agreements mainly resulted from the partial or entire recognition of the proceeds received pursuant to the agreements with AstraZeneca and Sanofi.

(Press release, Innate Pharma, MAY 13, 2026, View Source [SID1234665656])

On May 13, 2026 Innate Pharma SA (Euronext Paris: IPH; Nasdaq: IPHA) ("Innate" or the "Company") reported its business update and consolidated financial results for the quarter ending March 31, 2026.

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"We have continued to make solid progress across our priority clinical assets during the first quarter. We are approaching completion of enrollment in the Phase 1 dose escalation and backfill cohorts for IPH4502. In parallel, we have advanced the negotiations for non-dilutive financing options to allow initiation of the lacutamab confirmatory Phase 3 TELLOMAK-3 trial in CTCL. Finally, the Phase 3 PACIFIC-9 trial with AstraZeneca is planned for data readout in the second half of 2026. Separately, we were pleased to see encouraging results from the MATISSE Phase 2 trial presented at the AACR (Free AACR Whitepaper) Annual Meeting 2026. It is exciting to see the continued advancement of our differentiated immunotherapy pipeline for patients with high unmet medical need," said Jonathan Dickinson, Chief Executive Officer of Innate Pharma.

Webcast and conference call will be held today at 1:30 p.m. CEST (7:30 a.m. EDT)

Click here to access the live webcast.

Analysts may also join via telephone to ask questions, click here to register.

This information can also be found on the Investors section of the Innate Pharma website, www.innate-pharma.com.

A replay of the webcast will be available on the Company’s website for 90 days following the event.

1 Including short term investments (€4.9m) and non-current financial instruments (€10.4m).

Pipeline highlights:

Lacutamab (anti-KIR3DL2 antibody):

Cutaneous T-Cell Lymphoma

The planned confirmatory Phase 3 TELLOMAK-3 trial is an open-label, multi-center, randomized, comparative study evaluating lacutamab in patients with Sézary syndrome and mycosis fungoides, who have failed at least one prior systemic therapy.
TELLOMAK-3 includes two cohorts: a confirmatory cohort in Sézary syndrome, intended to support a potential accelerated approval based on existing TELLOMAK Phase 2 data, and a registrational cohort in mycosis fungoides, intended to support full approval. The primary endpoint of the study for both cohorts is progression-free survival (PFS) evaluated by blinded central review.
Following the U.S. Food and Drug Administration (FDA) review of the Phase 3 protocol, with no further comments in November 2025, the trial is planned for initiation in H2 2026.
The FDA provided encouraging feedback on the TELLOMAK Phase 2 results and the proposed regulatory pathway, which may support an accelerated approval in Sézary syndrome once the Phase 3 trial is underway. In February 2025, the FDA granted Breakthrough Therapy Designation to lacutamab for relapsed or refractory Sézary syndrome.
The TELLOMAK Phase 2 trial is completed, and patients still on treatment at the end of the study continue to receive lacutamab through a Post Trial Access program.
An abstract authored by ZS Associates entitled "Cutaneous T-Cell Lymphoma Epidemiology in the United States: A Real-World Data Analysis of Administrative Claims" has been accepted for publication in the official Abstract Book of the European Hematology Association (EHA) (Free EHA Whitepaper) Congress 2026. The analysis, sponsored by Innate, reports approximately 12,400 prevalent patients with mycosis fungoides (MF) and 1,100 with Sézary syndrome (SS), with ~2,900 and ~300 new cases per year, respectively.
Peripheral T-Cell Lymphoma (PTCL)

KILT (anti-KIR in T-Cell Lymphoma) Phase 2 trial, an investigator-sponsored, randomized study led by the Lymphoma Study Association (LYSA) evaluating lacutamab in combination with GEMOX (gemcitabine and oxaliplatin) versus GEMOX alone in patients with KIR3DL2-expressing relapsed/refractory PTCL, is ongoing.
IPH4502 (Nectin-4 exatecan ADC):

The IPH4502-101 Phase 1 study (NCT06781983), recruiting in France and in the United States, is evaluating the safety, tolerability, and preliminary anti-tumor activity of IPH4502 in advanced solid tumors known to express Nectin-4, including but not limited to urothelial carcinoma, non-small cell lung, breast, ovarian, gastric, esophageal, and colorectal cancers.
The maximum tolerated dose has been reached and enrollment in the Phase 1 dose escalation and cohort enrichment is nearing completion. Preliminary anti-tumor activity continues to be observed in heavily pre-treated patients with advanced solid tumors, including in patients with urothelial cancer relapsed or refractory to enfortumab vedotin, with a favorable safety profile to date.
Monalizumab (anti-NKG2A antibody), developed in collaboration with AstraZeneca:

The PACIFIC-9 Phase 3 trial run by AstraZeneca evaluating durvalumab (anti-PD‑L1) in combination with monalizumab or AstraZeneca’s oleclumab (anti-CD73) in patients with unresectable, Stage III non-small cell lung cancer (NSCLC) who have not progressed following platinum-based chemoradiation therapy (CRT) is ongoing. Enrollment in the trial is complete, and data readout is expected in H2 2026.
Other Clinical stage assets

IPH5201 (anti-CD39 antibody, developed in collaboration with AstraZeneca): The MATISSE Phase 2 trial is evaluating IPH5201 in combination with durvalumab and platinum-based chemotherapy in the neoadjuvant lung cancer setting.

Interim results from MATISSE Phase 2 were presented in a Clinical Trials Plenary Session at the AACR (Free AACR Whitepaper) Annual Meeting 2026 on April 21, 2026 in San Diego, by Pr. Fabrice Barlesi (Institut Gustave Roussy). The pre-planned interim analysis was conducted on 40 patients with resectable early-stage (stage II–IIIA) NSCLC treated with perioperative IPH5201 in combination with durvalumab and platinum-based chemotherapy. The combination showed encouraging results with overall pathological complete response (pCR) rate of 27.5% (95% CI: 14.6–43.9). pCR rates were notably higher in patients with PD-L1-positive tumors, reaching 35.7% in PD-L1 ≥1% patients (n=28%) and 50.0% in PD‑L1 ≥50% patients (n=14). Higher baseline tumor CD39+ and CD8+ cell density was observed in patients achieving pCR/mPR, suggesting CD39 expression as a potentially emerging biomarker. The safety profile was comparable to that of preoperative platinum-based chemotherapy with durvalumab. Based on these encouraging results, the MATISSE study continues enrollment in the PD-L1 ≥1% patient population.
IPH5301 (anti-CD73, proprietary): The investigator-sponsored CHANCES Phase 1 trial of IPH5301 with Institut Paoli-Calmettes is ongoing.

IPH6101 (ANKET anti-CD123, proprietary): Innate has initiated a research collaboration to further assess next steps of development.

IPH6401/SAR’514 (ANKET anti-BCMA, partnered with Sanofi): During the first quarter, Sanofi announced deprioritization of SAR’514, a trifunctional anti-BCMA NK-cell engager. Sanofi retains exclusive development and commercialization rights, and the license terms remain unchanged.

Corporate Update:

As previously announced, in line with its strategic focus, the Company has streamlined its organization. Planned layoffs were implemented through a redundancy plan which is completed.
As of March 31, 2026, the balance available under our April 2023 sales agreement under the At-The-Market program remains at $75 million.
Financial highlights for Q1 2026:

Cash, cash equivalents and financial assets of the Company amounted to €25.4 million as of March 31, 2026. At the same date, financial liabilities amounted to €20.3 million.

Revenue for the three-month period ending March 31, 2026, amounted to €2.6 million (€1.2 million for the same period in 2025). Revenue from collaboration and licensing agreements mainly resulted from the partial or entire recognition of the proceeds received pursuant to the agreements with AstraZeneca and Sanofi.

(Press release, Innate Pharma, MAY 13, 2026, View Source [SID1234665656])

On May 13, 2026 Adicet Bio, Inc. (Nasdaq: ACET), a clinical stage biotechnology company discovering and developing allogeneic gamma delta T cell therapies for autoimmune diseases and cancer, today reported financial results and operational highlights for the first quarter ended March 31, 2026.

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"Adicet is approaching a key inflection point as we prepare to report Phase 1 data for prula-cel in mid-year 2026, including data from at least 20 LN and SLE patients with a minimum of six months of follow-up," said Chen Schor, President and Chief Executive Officer of Adicet Bio. "Reaching this important inflection point builds on the collaboration of our employees and a global network of investigators and clinical sites advancing a comprehensive Phase 1 trial of a potential first-in-class gamma delta 1 CAR-T cell therapy in autoimmune diseases."

Mr. Schor continued, "In parallel, we are continuing to build our portfolio with ADI-212, a gene-edited and armored product candidate designed to enhance clinical activity in solid tumors and deliver multiple anti-tumor mechanisms of action to the tumor microenvironment. We are also advancing our ongoing preclinical programs and activities focused on a differentiated in vivo CAR-T platform targeting heme malignancies."

First Quarter 2026 and Recent Operational Highlights:

Autoimmune diseases

Phase 1 prula-cel clinical update in LN and SLE patients anticipated in mid-2026. The Company plans to provide its next clinical update in mid-2026 for its ongoing Phase 1 clinical trial evaluating prula-cel across multiple autoimmune conditions. Adicet also intends to meet with the FDA in the second quarter of 2026 to inform potential pivotal trial design. Subject to regulatory clearance to proceed, the Company expects to initiate start up activities for a pivotal program in LN or LN and SLE patients in the second half of 2026. In addition, following alignment with the FDA in November 2025, LN and SLE patients in the ongoing Phase 1 study and future studies may be dosed with prula-cel in the outpatient setting. The Company plans to provide a clinical update in patients with systemic sclerosis in the second half of 2026.
Ongoing Phase 1 trial of prula-cel in treatment-refractory rheumatoid arthritis (RA) to assess reduced conditioning regimens. The Phase 1 trial of prula-cel in RA is designed to assess two lymphodepletion approaches, cyclophosphamide alone and in combination with fludarabine. Primary objectives include evaluating safety and tolerability, with secondary assessments focused on cellular kinetics, pharmacodynamic markers, and disease activity measures. The next update on this trial is expected in the second half of 2026.
Solid tumor indications

Regulatory submission for ADI-212 planned for the third quarter of 2026 with Phase 1 start anticipated in the fourth quarter of 2026 pending regulatory clearance. Adicet continues to advance its next-generation gene-edited, armored cell therapy candidate targeting prostate-specific membrane antigen (PSMA). ADI-212 is engineered to express a novel CAR binder designed to support enhanced tolerability and tumor specific recognition. It integrates membrane tethered IL-12 armoring, and CRISPR/Cas9-mediated disruption of subunit 12 (MED12) to enhance potency in solid tumors and deliver multiple anti-tumor mechanisms of action within the tumor microenvironment. Adicet expects to submit a regulatory filing for ADI-212 for the treatment of mCRPC in the third quarter of 2026, with initiation of Phase 1 enrollment anticipated in the fourth quarter of 2026, subject to regulatory clearance.
Additional early-stage programs (CAR and other technologies)

Advancing innovation through a differentiated cell therapy platform. Adicet’s pipeline also includes additional early-stage gamma delta CAR-T cell therapy programs for autoimmune diseases, hematological malignancies and solid tumors. Additionally, Adicet has ongoing preclinical programs and activities focused on a differentiated in vivo CAR-T platform targeting heme malignancies.
Financial Results for First Quarter 2026:

Three months ended March 31, 2026

Research and Development (R&D) Expenses: R&D expenses were $17.5 million for the three months ended March 31, 2026, compared to $22.8 million during the same period in 2025. The decrease in R&D expenses was primarily due to a $3.6 million decrease in payroll and personnel expenses due to lower headcount, a $1.4 million decrease in expenses related to lab supplies and materials, a $0.5 million decrease related to lower CRO expenses and a $0.2 million decrease in allocated facility-related expenses. The decrease was partially offset by a $0.4 million increase in professional fees.
General and Administrative (G&A) Expenses: G&A expenses were $4.1 million for the three months ended March 31, 2026, compared to $7.1 million during the same period in 2025. The decrease in G&A expenses was due to a $1.4 million decrease in payroll and personnel-related expenses primarily due to a decrease in stock-based compensation and lower headcount, a $1.0 million decrease in allocated facility-related expenses and a $0.6 million decrease in professional fees.
Net Loss: Net loss for the three months ended March 31, 2026 was $20.2 million, or a net loss of $1.88 per basic and diluted share, including non-cash stock-based compensation expense of $1.3 million, as compared to a net loss of $28.2 million, or a net loss of $4.96 per basic and diluted share, including non-cash stock-based compensation expense of $3.2 million during the same period in 2025.
Cash Position: Cash, cash equivalents and short-term investments were $137.6 million as of March 31, 2026, compared to $158.5 million as of December 31, 2025. The Company expects that current cash, cash equivalents and short-term investments as of March 31, 2026, will be sufficient to fund its operating expenses into the second half of 2027.

(Press release, Adicet Bio, MAY 13, 2026, View Source [SID1234665655])

On May 13, 2026 Takeda (TOKYO:4502/NYSE:TAK) reported financial results for the fiscal year 2025 (period ended March 31, 2026). The Company delivered solid results in line with its latest FY2025 Management Guidance, reflecting strong OPEX savings, mitigating revenue headwinds while continuing to invest in future growth.

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Key Highlights for FY2025

Revenue decreased by 1.7% YoY at actual exchange rates (AER), resulting from the loss of exclusivity for VYVANSE which was partially mitigated by Growth and Launch Products. On a Core basis, Revenue decreased by 2.6% at Constant Exchange Rate (CER).
Core Operating Profit increased by 0.8% YoY at AER and declined by 0.9% at CER, protected by OPEX savings, while still investing for growth.
Reported Operating Profit increased by 19.3% YoY at AER, also reflecting a step-down in amortization expenses for VYVANSE and lower restructuring expenses.
Core EPS increased by 5.2% YoY at AER and by 3.1% at CER, while reported EPS increased by 78.1% YoY.
Adjusted Free Cash Flow amounted to JPY 684.5 billion, in line with forecast, and the Company ended fiscal year with strong cash balance.
Delivered key milestones for oveporexton, rusfertide, and zasocitinib, with positive Phase 3 readouts; completed regulatory submissions for oveporexton and rusfertide, and launch preparations underway.
Takeda Chief Executive Officer (CEO)-elect, Julie Kim, commented:
"FY2025 was a pivotal year, validating the strength of our execution against demanding development and regulatory milestones, the resilience of our commercial portfolio and our strong position with three major launches planned in the next 12 months and the most robust late-stage pipeline in our history. Our growth roadmap is built around two strategic horizons: transforming for growth through near-term launches and strengthening competitiveness and accelerating growth by transitioning to a new cohort of blockbuster brands, together positioning us for long-term profitable growth and patient impact."

Takeda Chief Financial Officer, Milano Furuta, commented:
"In FY2025, despite topline headwinds, we delivered solid profit and cash flow through disciplined cost control, while directing growth investment toward new product launches and the pipeline. In FY2026, we will continue to focus on transforming operations and protecting profitability while delivering successful launches and advancing our pipeline. Strong cash flow generation and deleveraging will support long-term investment for growth acceleration and ensure competitive returns for our shareholders."

Full-year FY2026 Forecast and Guidance
Based on the current business outlook and planned investment profile, Takeda issued the following FY2026 forecast and management guidance.

(Billion yen, except percentages and per share amounts)

Item

FY2026
FORECAST

FY2026

MANAGEMENT GUIDANCE

Core Change at CER

(Non-IFRS)

Revenue

4,640.0

—

Core Revenue (Non-IFRS)

4,640.0

Low- single digit % decline

Operating Profit

420.0

—

Core Operating Profit (Non-IFRS)

1,160.0

5% ~ 8% decline

Net Profit

166.0

—

EPS (Yen)

104

—

Core EPS (Yen (Non-IFRS)

472

Mid-teens % decline

Adjusted Free Cash Flow (Non-IFRS)

650.0-750.0

—

Annual Dividend per Share (Yen)

204

—

Pipeline Achievements Set the Stage for Future Growth
Our three leading late-stage assets are positioned for regulatory approvals in the U.S. and other geographies in FY2026-2027. We expect this will be a pivotal period for launches and investment with clear near-term wins and proof points over the next 12–24 months.

oveporexton:

Oveporexton is potentially a first-of-its-kind orexin agonist designed to address the underlying orexin deficiency that causes narcolepsy type 1.
Granted Priority Review by the U.S. FDA, Takeda is preparing for a U.S. commercial launch for oveporexton in the second half of 2026 and has also completed regulatory filings in Japan and China.
rusfertide:

Rusfertide is a potential first‑in‑class hepcidin mimetic that has demonstrated rapid, stable, and durable hematocrit control in patients with polycythemia vera, or PV, and has the potential to shift the standard of care in this blood cancer.
Granted Priority Review by the U.S. FDA, Takeda is preparing for a U.S. commercial launch for rusfertide in the second half of 2026.
zasocitinib:

Zasocitinib is poised to be a leading oral treatment option for psoriasis patients with the potential to significantly expand the oral segment in a growing psoriasis market.
Takeda is making decisive investments to support a planned regulatory filing in 2026 and a commercial launch in the first half of 2027.
FINANCIAL HIGHLIGHTS for FY2025 Ended March 31, 2026

(Billion yen, except percentages and per share amounts)

Item

FY2025

(Billion JPY)

FY2024

(Billion JPY)

YoY Growth

(AER)

Revenue

4,505.7

4,581.6

-1.7%

Operating Profit

408.8

342.6

+19.3%

Margin

9.1%

7.5%

+1.6pp

Net Profit

191.8

107.9

+77.7%

EPS (Yen)

122

68

+78.1%

Operating Cash Flow

1,041.4

1057.2

-1.5%

Adjusted Free Cash
Flow (Non-IFRS)

684.5

769.0

-11.0%

Core (Non-IFRS)

(Billion yen, except percentages and per share amounts)

Item

FY2025

(Billion JPY)

FY2024

(Billion JPY)

YoY Growth

(AER)

YoY Growth

(CER)

Revenue

4,505.7

4,579.8

-1.6%

-2.6%

Operating Profit

1,172.5

1,162.6

+0.8%

-0.9%

Margin

26.0%

25.4%

+0.6pp

—

Net Profit

814.1

775.6

+5.0%

+2.9%

EPS (Yen)

517

491

+5.2%

+3.1%

Capital Allocation and Shareholder Returns
Takeda maintains a disciplined capital allocation framework that prioritizes investments in new launches and R&D innovation to drive growth and enables the company to deliver returns to shareholders under its progressive dividend policy. In FY2025, the proposed annual dividend was JPY 200 per share, and year-end adjusted net debt/adjusted EBITDA was 2.6x.

Additional Information About Takeda’s FY2025 Results
Takeda will host a conference call for investors and analysts on Wednesday, May 13, 2026, at 7:00 PM JST / 6:00 AM EDT to discuss its full-year 2025 financial results.

A live webcast of the conference call, along with presentation materials, will be available on the investor relations section of Takeda’s website at www.takeda.com/investors. The presentation will contain further details on Takeda’s FY2025 results, commercial progress, pipeline updates, and other financial information, including key assumptions for the FY2026 forecast and definitions of non-IFRS measures.

(Press release, Takeda, MAY 13, 2026, View Source [SID1234665654])