On May 12, 2026 Xilio Therapeutics, Inc. (Nasdaq: XLO), a clinical-stage biotechnology company discovering and developing masked immuno-oncology therapies for people living with cancer, reported pipeline progress and business updates and reported financial results for the first quarter ended March 31, 2026.

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"We ended the first quarter of 2026 with strong momentum across our pipeline of highly differentiated I-O therapies leveraging our best-in-class masking technology," said René Russo, Pharm.D., president and chief executive officer of Xilio. "XTX501 has the potential to be a foundational backbone therapy for combination regimens across a broad range of solid tumors, and we are on track to advance this program into the clinic this year. In addition, our recent data for our CLDN18.2 program presented at AACR (Free AACR Whitepaper) further demonstrate the power of our masking technology to unlock the potential of T cell engagers. This progress, together with the recent achievement of another financial milestone under our AbbVie collaboration, highlights the productivity of our pipeline and underscores our ability to maximize the value of our clinically-validated masking technology."

Pipeline Progress and Business Updates

XTX501: bispecific PD-1 / masked IL-2

XTX501 is a novel bispecific PD-1 / masked IL-2 that has the potential to be a foundational "backbone" therapy for combination treatment with other agents. XTX501 is designed to selectively stimulate PD-1 positive, antigen-experienced T cells and enhance their function while overcoming IL-2 receptor-mediated clearance, peripheral activity and tolerability issues associated with non-masked IL-2 agents. In preclinical studies, XTX501 demonstrated robust monotherapy activity (including in settings insensitive to PD-1 therapy) and tumor-selective pharmacodynamics consistent with its intended mechanism of action.

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Xilio is currently advancing XTX501 through investigational new drug (IND)-enabling studies and plans to submit an IND application in the middle of 2026.
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Xilio plans to initiate a Phase 1 trial for XTX501 in the second half of 2026 and report initial Phase 1 data in patients with metastatic non-small cell lung cancer in the second half of 2027, subject to clearance of the IND by the U.S. Food and Drug Administration.

Masked T Cell Engager Programs

Xilio is leveraging its proprietary, clinically-validated masking technology and modular T cell engager (TCE) architectures to advance two wholly-owned masked TCE programs, as well as an additional masked TCE program in collaboration with AbbVie Group Holdings Limited (AbbVie).

Xilio’s masked TCEs include a masked CD3 targeting domain and one or more tumor-associated antigen (TAA) binding domains (which may be masked) as part of the core molecule design. Depending on the desired properties that Xilio is seeking to achieve for a particular molecule, Xilio’s modular architecture enables the ability to incorporate a co-stimulatory domain designed to further enhance potency and durability of T cell response, include multiple TAA binding domains and/or also mask the TAA binding domain(s) and/or co-stimulatory signaling domain. Upon tumor-selective activation, Xilio’s TCE molecules are designed to release a potent, short half-life TCE in the tumor microenvironment.

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Xilio is advancing XTX601, a potential first-in-class masked TCE targeting CLDN18.2, a TAA expressed in gastrointestinal cancers (gastric, pancreatic and esophageal). In parallel, Xilio is leveraging its modular design architecture to evaluate designs that incorporate masking of the CLDN18.2 binding domain and/or the addition of a co-stimulatory domain. Xilio initiated IND-enabling activities for its CLDN18.2 program in the first quarter of 2026.
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In April 2026, Xilio presented new preclinical data for XTX601 at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting demonstrating protease-dependent, tumor-selective activation and potent anti-tumor activity in multiple preclinical models. In addition, XTX601 was well-tolerated in non-human primates with a favorable therapeutic index. For more information, read the press release here.
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Xilio is also advancing a potential first-in-class multi-specific, masked TCE program targeting PSMA and STEAP1 with built-in co-stimulatory signaling. PSMA and STEAP1 are expressed in most prostate cancer tumors, and targeting both TAAs with a single molecule has the potential to address tumor heterogeneity while minimizing the potential for resistance due to antigen escape. Xilio anticipates initiating IND-enabling activities for its PSMA+STEAP1 program in the second quarter of 2026.
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Xilio plans to submit IND applications for its CLDN18.2 and PSMA+STEAP1 programs in 2027.

Efarindodekin alfa: masked IL-12

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Xilio is evaluating efarindodekin alfa as a monotherapy in an ongoing Phase 2 clinical trial in patients with advanced solid tumors and expects to deliver an option data package to Gilead Sciences, Inc. (Gilead) in the first half of 2027.

Recent Corporate Updates
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Xilio strengthened its board of directors with the appointment of Cheryl R. Blanchard, Ph.D., a renowned biopharmaceutical leader, in April 2026. Dr. Blanchard brings more than 30 years of leadership experience to Xilio, with deep scientific, operational and commercial leadership in life science companies.
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In the second quarter of 2026, Xilio achieved a $6.0 million development milestone related to the masked antibody-based immunotherapy program under the company’s collaboration, license and option agreement with AbbVie.

First Quarter 2026 Financial Results

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Cash Position: Cash and cash equivalents were $150.3 million as of March 31, 2026, compared to $137.5 million as of December 31, 2025. The increase was primarily driven by $37.3 million in net proceeds from a follow-on offering in February 2026.
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Collaboration and License Revenue: Collaboration and license revenue was $12.6 million for the quarter ended March 31, 2026, compared to $2.9 million for the quarter ended March 31, 2025. The increase was primarily driven by an increase in collaboration and license revenue recognized under the collaboration and license agreements with AbbVie and Gilead.
Exhibit 99.1

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Research & Development (R&D) Expenses: R&D expenses were $19.8 million for the quarter ended March 31, 2026, compared to $8.3 million for the quarter ended March 31, 2025. The increase was primarily driven by manufacturing activities related to IND-enabling studies and preclinical development activities for XTX501, increased costs related to masked TCE programs and indirect research and development, increased clinical development activities related to efarindodekin alfa and increased personnel-related costs.
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General & Administrative (G&A) Expenses: G&A expenses were $6.9 million for the quarter ended March 31, 2026, compared to $8.5 million for the quarter ended March 31, 2025. The decrease was primarily driven by a decrease in professional and consulting fees, including legal fees and other professional costs and a decrease in personnel-related costs.
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Net Loss: Net loss was $9.5 million for the quarter ended March 31, 2026, compared to a net loss of $13.3 million for the quarter ended March 31, 2025.

Cash Runway

Based on its current operating plans, Xilio anticipates that its cash and cash equivalents as of March 31, 2026, together with the development milestone achieved under the AbbVie collaboration in the second quarter of 2026, will be sufficient to enable it to fund its operating expenses and capital expenditure requirements into early 2028.

This estimate excludes any potential additional milestone payments, option-related fees or other contingent payments under Xilio’s collaboration and license agreements with AbbVie and Gilead and excludes up to $36.2 million in additional gross proceeds in the second half of 2026 if all outstanding Series C warrants are exercised at their current exercise price.

Xilio has the potential to achieve up to $31.0 million in additional near-term milestones and option extension fees under the existing AbbVie collaboration through the first half of 2027.

(Press release, Xilio Therapeutics, MAY 12, 2026, View Source [SID1234665562])

On May 12, 2026 Tevogen ("Tevogen Bio Holdings Inc." or "Company") (Nasdaq: TVGN) reported that it has entered into a securities purchase agreement for a private investment in public equity (the "PIPE") financing with existing investor The Patel Family, LLP for gross proceeds of $3 million. The Company intends to use the proceeds from the PIPE financing to support ongoing operations, advance strategic growth initiatives, and for general corporate purposes.

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Pursuant to the terms of the securities purchase agreement, Tevogen will issue 375,000 prefunded warrants each exercisable for the purchase of one share of the Company’s common stock. The PIPE financing was priced at $8.00 per prefunded warrant, which represents a 14% premium to the closing price of the Company’s stock on May 11, 2026. The PIPE financing is expected to close on or about May 13, 2026.

"Having The Patel Family, LLP continue to support Tevogen reflects a shared belief in both our mission and our long-term vision for building a more accessible and sustainable healthcare model," said Tevogen Bio founding CEO Ryan Saadi, MD, MPH. "We believe this financing along with an existing ATM offering and loan agreement, provides the company with access to adequate capital to reach revenue milestones."

"Our continued investment emphasizes our conviction in Tevogen, its leadership and novel technology, and we look forward to being long-term holders," said investor Dr. Manmohan Patel, MD, on behalf of The Patel Family, LLP.

The securities issued in the PIPE financing have not been registered under the Securities Act of 1933, as amended, or applicable state securities laws. Accordingly, the securities may not be reoffered or resold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act and such applicable state securities laws. In connection with the private placement, the Company has agreed to file a registration statement with the U.S. Securities and Exchange Commission covering the resale of the shares issuable upon exercise of the prefunded warrants.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy any securities, nor shall there be any sale of these securities in any jurisdiction in which such offer, solicitation, or sale would be unlawful prior to the registration or qualification under the securities laws of any such jurisdiction.

(Press release, Tevogen Bio, MAY 12, 2026, View Source [SID1234665579])

On May 12, 2026 Bristol Myers Squibb (NYSE: BMY, "BMS") and Hengrui Pharma ("Hengrui") (600276.SH; 01276.HK) reported the companies have entered into global strategic collaboration and license agreements to advance a portfolio of 13 early stage programs in oncology, hematology and immunology, with the goal of accelerating discovery and development of innovative medicines for the benefit of patients worldwide.

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The agreements include four oncology/hematology assets from Hengrui, four immunology assets from BMS, and five innovative assets to be jointly discovered and developed by both companies, leveraging Hengrui’s discovery engine and platform technologies across several innovative modalities. Hengrui has the option to co-develop select assets and the potential to conduct certain commercialization activities globally with BMS.

Under the collaboration, BMS obtains exclusive worldwide rights to the Hengrui‑originated assets outside Chinese mainland, Hong Kong SAR, and Macau SAR (the "Hengrui Territory"), while Hengrui obtains exclusive rights to the BMS‑originated assets within the Hengrui Territory, with BMS retaining rights for the rest of the world. Hengrui will be fully responsible for early clinical development to accelerate clinical proof of concept for these programs.

Aligned with the collaborative innovation strategies of both BMS and Hengrui, these agreements reflect the companies’ continued focus on advancing innovative science through partnership in areas of significant unmet medical need. The collaboration brings together BMS’s differentiated research and discovery strengths, global clinical development capabilities, regulatory expertise, and commercial scale with Hengrui Pharma’s discovery engine, platform technologies, and efficient early-stage development expertise, enabling the advancement of a broad portfolio of high-value programs.

"This strategic collaboration reflects our commitment to advancing innovative science while maintaining a disciplined approach to portfolio management," said Robert Plenge, MD, PhD, Executive Vice President and Chief Research Officer, Bristol Myers Squibb. "By leveraging complementary capabilities across geographies, we aim to accelerate early clinical learning and make informed decisions that support driving top tier growth in the next decade and, ultimately, our mission to deliver medicines that help patients prevail over serious diseases."

"This broad strategic collaboration reflects a highly synergistic collaboration between two global innovators with complementary strengths. By leveraging Hengrui’s growing R&D capabilities and proven efficiency in discovering and advancing innovative therapies, we are poised to advance the best of both pipelines," said Frank Jiang, MD, PhD, Executive Vice President and Chief Strategy Officer of Hengrui Pharma. "It also reflects Hengrui’s continued commitment to strengthen our global presence. Together, we aim to deliver meaningful benefits to patients worldwide."

Under the terms of the agreement, BMS will pay Hengrui up to $950 million, including a $600 million upfront payment, a $175 million first anniversary payment, and a second contingent anniversary payment of $175 million in 2028. The potential total value of the agreement is up to approximately $15.2 billion, including the exercise of available options for the joint discovery programs and the achievement of applicable development, regulatory, and commercial milestones for all programs. In addition, Hengrui is eligible to receive tiered royalties on net sales of products commercialized outside the Hengrui Territory.

The transaction is subject to review under the Hart‑Scott‑Rodino Antitrust Improvements Act and other customary closing conditions. The parties expect that the agreement will close in the third quarter of 2026.

(Press release, Bristol-Myers Squibb, MAY 12, 2026, View Source [SID1234665453])

On May 12, 2026 Arvinas, Inc. (Nasdaq: ARVN), a clinical-stage biotechnology company creating a new class of drugs based on targeted protein degradation, reported financial results for the first quarter 2026, and provided a corporate update.

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"The approval of VEPPANU is a defining achievement for Arvinas and reflects the culmination of more than a decade of focused work to translate our PROTAC science into our first approved therapy," said Randy Teel, Ph.D., President and Chief Executive Officer at Arvinas. "I’m proud to lead an organization advancing an industry-leading portfolio of degraders – one that has now joined the short list of those able to bring a new therapeutic modality from discovery to approval. As we move through the remainder of the year, our focus is on delivering key data and clinical milestones that we believe will further validate our approach and clearly distinguish our programs in an increasingly competitive environment."

1Q 2026 Business Highlights and Recent Developments

Approved Product
VEPPANU (vepdegestrant): Oral PROTAC ER degrader
As part of Arvinas global collaboration with Pfizer, the companies:

Announced the approval of VEPPANU for the treatment of adults with estrogen receptor-positive (ER+)/human epidermal growth factor receptor 2-negative (HER2-), estrogen receptor 1 (ESR1)-mutated advanced or metastatic breast cancer, as detected by an FDA-authorized test, with disease progression following at least one line of endocrine therapy.
This approval marks the first time the U.S. Food and Drug Administration (FDA) has approved a PROteolysis TArgeting Chimera (PROTAC), a type of heterobifunctional protein degrader therapy.
Entered into a license agreement with Rigel Pharmaceuticals, Inc. for the for the exclusive global development, manufacturing, and commercialization rights for VEPPANU.
On May 8, 2026, the National Comprehensive Cancer Network (NCCN) added vepdegestrant (VEPPANU) to the latest NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines) for Breast Cancer. Vepdegestrant (VEPPANU) was added as a Category 2A treatment option for patients with hormone receptor (HR)-positive/HER2-negative, ESR1-mutated advanced or metastatic breast cancer after at least one line of endocrine therapy + cyclin-dependent kinase (CDK) 4/6 inhibitor.*
Pipeline
ARV-102: Oral PROTAC LRRK2 degrader

Presented Phase 1 data for ARV-102 at the 2026 International Conference on Alzheimer’s and Parkinson’s Diseases and Related Neurological Disorders (AD/PD 2026) showing greater than 50% LRRK2 degradation in cerebrospinal fluid (CSF) of patients with Parkinson’s disease treated for 28 days. Additional key findings from the trial showed:
Reduction of key endolysosomal and neuroinflammatory biomarkers (e.g., CD68, GPNMB) previously shown to be elevated in neurodegenerative diseases like Parkinson’s disease and progressive supranuclear palsy (PSP).
This level of biomarker modulation has not previously been demonstrated by LRRK2 inhibitors.
Dose-dependent exposure increases in CSF after multiple doses, indicating brain penetration.
Approximately 50% or greater LRRK2 reduction in CSF at all doses by day 14 and maintained through day 28, indicating substantial central LRRK2 protein degradation.
ARV-102 was generally safe and well tolerated with no serious adverse events reported after multiple doses.
ARV-806: Novel PROTAC KRAS G12D degrader

Completed dose escalation enrollment in the Phase 1 clinical trial evaluating ARV-806 in patients with solid tumors harboring KRAS G12D mutations (ClinicalTrials.gov Identifier: NCT07023731).
ARV-393: Oral PROTAC BCL6 degrader

Initiated a Phase 1 combination trial with glofitamab in patients with diffuse large B-cell lymphoma (DLBCL).
Continued dose escalation in the Phase 1 trial in patients with non-Hodgkin’s lymphoma (NHL).
Multiple responses observed in early cohorts at doses below the predicted effective exposure level in patients with both B- and T-cell lymphomas.
ARV-027: Oral PROTAC polyQ-AR degrader

Initiated a first-in-human Phase 1 clinical trial in healthy volunteers.
Presented preclinical data at the 2026 Kennedy’s Disease Association Conference.
In an aggressive spinal bulbar muscular atrophy mouse model, ARV-027 degraded polyQ-AR in muscle, which led to meaningful functional improvements and extended survival.
ARV-6723: Oral PROTAC HPK1 degrader

Presented preclinical data at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Immuno-Oncology Conference that we believe support clinical investigation of ARV-6723 in patients with solid tumors harboring high- or low-immunogenic tumor microenvironments (TME), including immune checkpoint inhibitor (ICI)-resistant tumor settings.
Robust single-agent antitumor and proinflammatory activity observed in multiple syngeneic tumor models, including those with immunosuppressive TMEs, and showed greater preclinical activity than an investigational HPK1 inhibitor or an anti-PD-1 antibody.
Presented preclinical data at the AACR (Free AACR Whitepaper) Annual Meeting demonstrating greater antitumor activity than standard-of-care ICIs or an investigational HPK1 inhibitor.
Unlike an inhibitor and ICIs, ARV-6723 reversed T-cell exhaustion, reversed the immunosuppressive TME, and boosted innate cell immunity in ICI-(aPD1 and aCTLA4) resistant models.
Novel pan-KRAS degrader:

Presented preclinical data at the AACR (Free AACR Whitepaper) Special Conference in Cancer Research: RAS Oncogenesis and Therapeutics.
Robust efficacy observed in CDX models of pancreatic, colorectal, and lung cancer.
Greater tumor growth inhibition than a pan-RAS (ON) inhibitor demonstrated in a KRAS G13D model.
Enhanced combination efficacy with immune checkpoint blockade compared with a pan-RAS (ON) inhibitor observed in a KRAS G12D syngeneic model.
Corporate

Announced the appointment of Randy Teel, Ph.D., as President, Chief Executive, and Director.
Dr. Teel succeeds John Houston, Ph.D., who retired from his role as President, Chief Executive Officer, and Chair of Arvinas’ Board of Directors. Dr. Houston will continue to serve as a member of the Board and has entered into a consulting agreement with Arvinas to provide consulting and advisory services to the Company.
Briggs Morrison, M.D., was elected by the Board to serve as Chair of the Arvinas Board of Directors.
Anticipated Upcoming Milestones and Expectations

Pipeline
ARV-102: Oral PROTAC LRRK2 degrader

Initiate Phase 1b clinical trial in patients with PSP upon receipt of FDA clearance to proceed (2H 2026, pending regulatory feedback).
Potential to initiate a registrational trial in PSP in late 2026, pending regulatory feedback.
Share additional biomarker data from Phase 1 trial in patients with Parkinson’s disease (2H 2026).
ARV-806: Novel PROTAC KRAS G12D degrader

Initiate enrollment in the dose expansion cohort of the Phase 1 trial of ARV-806 in patients with solid tumors harboring KRAS G12D mutations (ClinicalTrials.gov Identifier: NCT07023731).
Share initial clinical data in patients with solid tumors harboring KRAS G12D mutations (2026).
ARV-393: Oral PROTAC BCL6 degrader

Share updated clinical data from the ongoing Phase 1 clinical trial in patients with relapsed/refractory non-Hodgkin’s lymphoma (ClinicalTrials.gov Identifier: NCT06393738) at a medical congress (2H 2026).
Continue enrollment of a combination cohort with glofitamab in patients with DLBCL in the ongoing Phase 1 clinical trial.
ARV-027: Oral PROTAC polyQ-AR degrader

Continue enrollment in the Phase 1 clinical trial in healthy volunteers.
ARV-6723: Oral PROTAC HPK1 degrader

Initiate Phase 1 clinical trial in patients with advanced solid tumors (mid-2026).
ARV-6723 is Arvinas’ first immuno-oncology clinical candidate.
Approved Product
VEPPANU (vepdegestrant): Oral PROTAC ER degrader
As part of Arvinas’ global collaboration with Pfizer, the companies plan to:

Complete closing of the licensing transaction of VEPPANU to Rigel, which is subject to the parties’ receipt of any necessary consents or approvals, including the expiration or termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended.
Financial Guidance
Based on its current operating plan, Arvinas believes its cash, cash equivalents, and marketable securities as of March 31, 2026, is sufficient to fund planned operating expenses and capital expenditure requirements into the second half of 2028.

First Quarter Financial Results
Cash, Cash Equivalents, and Marketable Securities Position: As of March 31, 2026, cash, cash equivalents, and marketable securities were $614.9 million as compared with $685.4 million as of December 31, 2025. The decrease in cash, cash equivalents, and marketable securities of $70.5 million for the three months ended March 31, 2026, was primarily related to cash used in operations of $67.5 million, unrealized losses on marketable securities of $1.6 million, and the purchase of lab equipment and leasehold improvements of $1.3 million.

Research and Development Expenses: Generally Accepted Accounting Principles (GAAP) research and development (R&D) expenses were $60.3 million for the quarter ended March 31, 2026, as compared with $90.8 million for the quarter ended March 31, 2025. The decrease in R&D expenses of $30.5 million for the quarter was primarily due to a decrease in compensation and related personnel expenses of $15.6 million, which are not allocated by program, and a decrease in external expenses of $14.2 million. External expenses include program-specific expenses, which decreased by $9.5 million, primarily driven by a decrease in our vepdegestrant (ARV-471) program of $15.2 million, partially offset by an increase in our ARV-806 program of $5.6 million, and non-program specific expenses, which decreased by $4.7 million.

Non-GAAP R&D expenses were $54.3 million for the quarter ended March 31, 2026, as compared with $79.3 million for the quarter ended March 31, 2025, excluding $0.3 million of restructuring expense for the quarter ended March 31, 2026, and $5.7 million and $11.5 million of non-cash stock-based compensation expense for the quarters ended March 31, 2026, and 2025, respectively. A reconciliation of GAAP to non-GAAP financial measures used in this press release can be found at the end of this press release.

General and Administrative Expenses: GAAP General and administrative (G&A) expenses were $19.1 million for the quarter ended March 31, 2026, as compared with $26.6 million for the quarter ended March 31, 2025. The decrease in G&A expenses of $7.5 million for the quarter was primarily due to a decrease in professional fees of $5.3 million.

Non-GAAP G&A expenses were $13.0 million for the quarter ended March 31, 2026, as compared with $23.1 million for the quarter ended March 31, 2025, excluding $0.8 million of restructuring expenses for the quarter ended March 31, 2026, and $5.3 million and $3.5 million of non-cash stock-based compensation expense for the quarter ended March 31, 2026, and 2025, respectively. A reconciliation of GAAP to non-GAAP financial measures used in this press release can be found at the end of this press release.

Revenue: Revenue was $15.6 million for the quarter ended March 31, 2026, as compared with $188.8 million for the quarter ended March 31, 2025. Revenue for the quarter is related to the Vepdegestrant (ARV-471) Collaboration Agreement with Pfizer and the collaboration and license agreement with Pfizer. The decrease of $173.2 million was primarily due to a decrease in revenue from the Vepdegestrant (ARV-471) Collaboration Agreement with Pfizer driven by changes in total program cost estimates recognized in 2025 resulting from the removal of two Phase 3 trials from the development plan.

Investor Call & Webcast Details
Arvinas will host a conference call and webcast today, May 12, 2026, at 8:00 a.m. ET to review its first quarter 2026 financial results and discuss recent corporate updates. Participants are invited to listen by going to the Events and Presentation section under the Investors page on the Arvinas website at www.arvinas.com. A replay of the webcast will be available on the Arvinas website following the completion of the event and will be archived for up to 30 days.

(Press release, Arvinas, MAY 12, 2026, View Source [SID1234665523])

On May 12, 2026 Immatics N.V. (NASDAQ: IMTX, "Immatics" or the "Company"), the global leader in precision targeting of PRAME with multiple clinical-stage programs spanning cell therapies and bispecifics, reproted a business update and announced financial results for the quarter ended March 31, 2026.

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"Immatics is entering a pivotal period as we continue to progress toward the pre-specified interim and final analyses from the Phase 3 SUPRAME trial of anzu-cel and actively prepare for commercialization in 2027," said Harpreet Singh, Ph.D., Chief Executive Officer and Co-Founder of Immatics. "At the same time, we expect multiple meaningful clinical readouts across our PRAME franchise in 2026 that continue to validate PRAME as an important target across multiple solid cancers, extending well beyond melanoma, and across two different therapeutic modalities. Immatics today is a company defined not only by compelling science, but by a diversified late- and mid-stage clinical portfolio, growing commercial readiness, and a clear strategy to translate innovation into meaningful patient impact."

First Quarter 2026 and Subsequent Company Progress

PRAME Franchise – Cell Therapy

Anzu-cel (IMA203) PRAME Cell Therapy – First Market Entry in Advanced Melanoma
Anzu-cel (anzutresgene autoleucel), previously called IMA203, is Immatics’ lead PRAME cell therapy and is expected to be the Company’s first PRAME therapy to enter the market in advanced melanoma. The current addressable patient population for anzu-cel’s first target indications, second-line or later (2L) advanced cutaneous melanoma, as well as metastatic uveal melanoma includes ~9,000 patients2.

Anzu-cel received Orphan Drug Designation and RMAT designation3 from the U.S. Food and Drug Administration (FDA) for the treatment of both cutaneous and uveal melanoma.
Secondary analyses of Phase 1b clinical data on anzu-cel in advanced cutaneous and uveal melanoma will be presented during the Oral Abstract Session – Melanoma/Skin Cancers at the 2026 ASCO (Free ASCO Whitepaper) Annual Meeting, with a focus on characterizing response dynamics.
Phase 3 trial, SUPRAME, for anzu-cel (IMA203) in previously treated, advanced cutaneous melanoma

Immatics’ global, randomized, controlled, multi-center Phase 3 clinical trial, SUPRAME, is currently ongoing to evaluate the efficacy, safety and tolerability of anzu-cel PRAME cell therapy as monotherapy vs. investigator’s choice in patients with unresectable or metastatic cutaneous melanoma who have received prior treatment with a PD-1 immune checkpoint inhibitor.
SUPRAME is designed to be an adequate and well-controlled clinical trial intended to generate data to support regulatory approval of anzu-cel.
Primary endpoint for seeking full approval is blinded independent central review ("BICR")-assessed (RECIST v1.1) progression-free survival (PFS). Secondary endpoints include overall survival (OS), objective response rate (ORR), safety and patient-reported outcomes measuring quality of life.
Pre-specified interim and final data analyses are expected to be triggered in 2026 upon the occurrence of a defined number of events for PFS (progressive disease or death).
The Company continues to expect BLA submission in the first half of 2027 and commercial launch of anzu-cel in the second half of 2027.
Patient recruitment is currently ongoing in North America and Europe.
Phase 2 cohort for anzu-cel (IMA203) PRAME cell therapy in patients with metastatic uveal melanoma

A Phase 2 cohort to treat approximately 30 additional metastatic uveal melanoma patients is ongoing and being conducted at select centers in the U.S. and Germany with expertise in uveal melanoma.
Data from the ongoing single-arm Phase 1b trial as well as the Phase 2 cohort in metastatic uveal melanoma are intended to support a potential label expansion for anzu-cel following expected initial approval in cutaneous melanoma.
IMA203CD8 PRAME Cell Therapy (GEN2) – Expansion to all Advanced PRAME Cancers
IMA203CD8 is the Company’s second-generation PRAME cell therapy product candidate being developed with the goal of expanding into all advanced PRAME cancers. Given its enhanced pharmacology profile, once the target dose is reached, the Company intends to pursue the clinical development of this product candidate with a tumor-agnostic approach, starting with gynecologic cancers (ovarian and uterine).

Updated Phase 1a dose-escalation and Phase 1b dose-expansion data in gynecologic cancers at clinically relevant dose levels will be presented during the Rapid Oral Abstract Session – Gynecological Cancer at the 2026 ASCO (Free ASCO Whitepaper) Annual Meeting.
The Company is on track to complete Phase 1a dose escalation and determine the recommended Phase 2 dose (RP2D) in 2026.
Further Updates on PRAME Cell Therapies

PRAME cell therapy beyond melanoma and gynecologic cancers: updated Phase 1 data on PRAME cell therapies (anzu-cel or IMA203CD8 GEN2) in synovial sarcoma, further demonstrating the potential to address diverse tumor types beyond melanoma and gynecologic cancers, will be presented during the Rapid Oral Abstract Session – Sarcoma at the 2026 ASCO (Free ASCO Whitepaper) Annual Meeting.
PRAME cell therapy using Immatics’ TCR in a pediatric patient with cancer: a late-breaking poster on a PRAME-directed TCR T-cell therapy using Immatics’ PRAME TCR administered under named-patient use in a heavily pretreated pediatric patient with extensive, multifocal nephroblastoma was presented at AACR (Free AACR Whitepaper) Annual Meeting 2026. PRAME is expressed across multiple pediatric cancers, and these findings highlight the therapeutic potential of PRAME cell therapy in pediatric patients with solid tumors.
PRAME Franchise – Bispecifics

IMA402 PRAME Bispecific – Expansion to Earlier-Line PRAME Cancers

To expand our PRAME opportunity to earlier-line PRAME cancers, the Company is developing its off-the-shelf, next-generation, half-life extended TCR bispecific, IMA402, as a monotherapy or in combination with standard of care, with a focus on melanoma and gynecologic cancers. In addition, Immatics is exploring the potential combination of IMA402 PRAME bispecific with IMA401 MAGEA4/8 bispecific in squamous non-small cell lung cancer (sqNSCLC) and potentially other solid tumor indications.

IMA402 PRAME bispecific showed clinical proof-of-concept during the Phase 1a dose escalation trial in heavily pre-treated patients with solid tumors, including melanoma and ovarian cancer.
Immatics expects to determine the final RP2D and present a clinical data update from a larger patient population, with an initial focus on melanoma and gynecologic cancers treated with IMA402 monotherapy or combination with an immune checkpoint inhibitor, in the second half of 2026. As part of its strategy to maximize the IMA402 opportunity, the Company is in the process of opening additional Phase 1b cohorts in mid-2026 across both earlier and later treatment lines.
Based on the initial promising activity of IMA401 in head and neck cancer and sqNSCLC, Immatics believes it is uniquely positioned to assess the synergistic potential of combining two different bispecifics, IMA402 targeting PRAME and IMA401 targeting MAGEA4/8, with and without a checkpoint inhibitor. The Phase 1 trial evaluating the combination of IMA401/IMA402 in sqNSCLC is expected to commence mid-2026.

IMA401 MAGEA4/8 Bispecific – Maximizing the Potential of Bispecifics Combinations

Updated results for IMA401 targeting MAGEA4/8 across multiple cancers will be presented during the Developmental Therapeutics – Immunotherapy Oral Abstract Session at the 2026 ASCO (Free ASCO Whitepaper) Annual Meeting.
IMA401 clinical development will focus on a combination approach with the Company’s PRAME bispecific, IMA402, to exploit synergistic potential and expanded patient reach.
The Phase 1 trial evaluating the combination of IMA401/IMA402 is expected to commence with sqNSCLC in mid-2026.

Corporate Development:

In collaboration, Moderna and Immatics developed a cancer antigen therapeutic candidate under the Database Program, incorporating targets identified using Immatics’ XPRESIDENT target discovery and validation platform and its bioinformatics and AI platform XCUBE. The shared antigen therapeutic candidate owned by Moderna was submitted for IND, marking a key regulatory milestone under the Collaboration Agreement and triggering a milestone payment to Immatics.

First Quarter 2026 Financial Results

Cash Position: Cash and cash equivalents, as well as other financial assets, total $521.5 million1 (€453.6 million) as of March 31, 2026, compared to $539.6 million1 (€469.3 million) as of December 31, 2025. The decrease is the result of ongoing research and development activities, partially offset by the net proceeds of an at-the-market offering of $24.4 million1 net (€21.2 million) as well as changes in net working capital and foreign exchange rate differences.

Revenue: Total revenue, consisting of revenue from collaboration agreements, was $8.7 million1 (€7.6 million) for the three months ended March 31, 2026, compared to $21.4 million1 (€18.6 million) for the three months ended March 31, 2025. The decrease is mainly due to a lower proportion of costs incurred relative to the overall project progress within the quarter.

Research and Development Expenses: R&D expenses were $68.1 million1 (€59.2 million) for the three months ended March 31, 2026, compared to $48.2 million1 (€41.9 million) for the three months ended March 31, 2025. The increase mainly resulted from costs associated with the advancement of the product candidates in clinical trials, particularly the SUPRAME clinical trial.

General and Administrative Expenses: G&A expenses were $16.7 million1 (€14.5 million) for the three months ended March 31, 2026, compared to $13.9 million1 (€12.1 million) for the three months ended March 31, 2025. The increase is driven by costs associated with early commercial activities supporting the planned market launch of anzu-cel (IMA203).

Net Profit and Loss: Net loss was $66.5 million1 (€57.8 million) for the three months ended March 31, 2026, compared to a net profit of $45.9 million1 (€39.9 million) for the three months ended March 31, 2025. The decrease is driven by higher recognition of non-cash revenue in the three months ended March 31, 2025 compared to the three months ended March 31, 2026 and from higher costs associated with the planned advancement of the Company’s PRAME franchise in clinical trials in the three months ended March 31, 2026.

Full financial statements can be found in our Report on Form 6-K filed with the Securities and Exchange Commission (SEC) on May 12, 2026, and published on the SEC website under www.sec.gov.

Upcoming Investor Conferences

Bank of America Healthcare Conference, Las Vegas (NV), USA – May 12 – 14, 2026
Jefferies Global Healthcare Conference, New York (NY), USA – June 2 – 4, 2026
Cantor Global Healthcare Conference, New York (NY), USA – September 9 – 11, 2026

To see the full list of events and presentations, visit: View Source

About PRAME
PRAME is a target expressed in more than 50 cancers. Immatics is the global leader in precision targeting of PRAME and has the broadest PRAME franchise with the most PRAME indications and modalities. The Immatics PRAME franchise currently includes three product candidates, two therapeutic modalities and two combination therapies that target PRAME: anzu-cel (anzutresgene autoleucel, IMA203) PRAME cell therapy, IMA203CD8 PRAME cell therapy (GEN2), IMA402 PRAME bispecific as monotherapy and in combination with an immune checkpoint inhibitor, as well as anzu-cel in combination with Moderna’s PRAME mRNA designed to enhance cell therapy.

(Press release, Immatics, MAY 12, 2026, View Source [SID1234665538])