On May 13, 2025 iTeos Therapeutics, Inc. (Nasdaq: ITOS), a clinical-stage biopharmaceutical company pioneering the discovery and development of a new generation of immuno-oncology therapeutics for patients, reported topline results from an updated interim analysis of GALAXIES Lung-201, the Phase 2 platform study sponsored by iTeos’ development partner GSK assessing the belrestotug + dostarlimab doublet in previously untreated, unresectable, locally advanced or metastatic PD-L1 high non-small cell lung cancer (NSCLC) (Press release, iTeos Therapeutics, MAY 13, 2025, View Source [SID1234652972]).

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The GALAXIES Lung-201 data continued to demonstrate clinically meaningful improvements in the trial’s primary endpoint of objective response rate (ORR), however the analysis did not meet established criteria for clinically meaningful improvements in the secondary endpoint of progression free survival in the belrestotug + dostarlimab combination cohorts versus dostarlimab monotherapy. Additionally, an interim analysis of the GALAXIES H&N-202 Phase 2 trial showed a trend below the meaningful threshold for ORR in the belrestotug combination cohorts vs. dostarlimab monotherapy in PD-L1 positive head and neck squamous cell carcinoma.

Based on these results, iTeos and GSK have made the decision to terminate the belrestotug development program and end the collaboration. All belrestotug-containing cohorts are ending, and any new enrollment in the ongoing GALAXIES Lung-301 Phase 3 trial is ending. GSK is communicating with investigators, institutional review boards, ethics committees, and health authorities about next steps for appropriate management of currently enrolled patients.

"We are truly disappointed by the results from GALAXIES Lung-201," said Michel Detheux, Ph.D., president and chief executive officer of iTeos. "Following the analysis of the TIGIT data generated to-date with GSK, we have made the mutual decision to discontinue development of all ongoing TIGIT studies. We are grateful to all patients, caregivers, and investigators involved in the GALAXIES studies and believe it is important to share these data with the scientific community at an upcoming medical meeting in order to advance our collective understanding of immuno-oncology and TIGIT."

"Since founding this company over a decade ago, I could not be prouder of the team we have built, the quality of science produced, and our collective commitment to improving the lives of cancer patients in need. However, given current market conditions and our appreciation of the responsibility to our valued shareholders, we believe the best path forward is to promptly evaluate a full range of strategic alternatives to unlock the value of our assets. With a strong balance sheet and a commitment to disciplined execution, we are well positioned to pursue opportunities that maximize shareholder value," continued Dr. Detheux.

On May 13, 2025 Intensity Therapeutics, Inc. ("Intensity" or "the Company") (Nasdaq: INTS), a late-stage clinical biotechnology company focused on the discovery and development of proprietary, novel immune-based intratumoral cancer therapies designed to kill tumors and increase immune system recognition of cancers, reported first quarter 2025 financial results and provides a corporate update (Press release, Intensity Therapeutics, MAY 13, 2025, View Source [SID1234652971]).

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Corporate Update

INVINCIBLE-4 Study: Phase 2 randomized open-label, multicenter study to analyze the clinical activity, safety, and tolerability of INT230-6 given before administration of the standard of care ("SOC") treatment in patients with early-stage, operable triple-negative breast cancer ("TNBC") and SOC alone. The primary endpoint is the change in the pathological complete response rate for the combination compared to the SOC alone. The INVINCIBLE-4 Study is recruiting patients in Switzerland and is expected to enroll 54 patients across Switzerland and France.

In April 2025, the Company and The Swiss Group for Clinical Cancer Research SAKK, a decentralized academic research institute that has been conducting clinical trials of cancer treatments in all major Swiss hospitals since 1965, announced that the European Medicines Agency has authorized the initiation of the INVINCIBLE-4 Study in France in collaboration with Unicancer. The Unicancer French breast intergroup (UCBG) is the French referent cooperative group in breast cancer. The French National Cancer Institute (INCa) accredited the group in 2013, thus acknowledging its academic excellence and operational capability. Since its creation, the group has conducted more than 40 national and international multicenter clinical trials, as well as various translational research projects.

INVINCIBLE-3 Study: Phase 3 open-label, randomized study testing INT230-6 as monotherapy compared to the SOC drugs in second and third line treatment for certain soft tissue sarcoma subtypes. The INVINCIBLE-3 Study is expected to enroll 333 patients and initiate sites in eight countries. This study has been authorized by the US FDA, Health Canada, the European Medicines Authority (for France, Germany, Italy, Poland and Spain), and Australia’s Therapeutics Goods Administration. The primary endpoint in the INVINCIBLE-3 Study is overall survival.

In March 2025, the Company paused new site activations and patient enrollments due to funding constraints, and prioritized funding for the INVINCIBLE-4 Study. Prior to this pause, the trial had enrolled 23 patients. The Company will continue to treat all patients enrolled in this study in cooperation with its third-party contract research organizations to reduce ongoing costs during this pause.

April 2025 Public Offering: In April 2025, the Company entered into a Securities Purchase Agreement with certain institutional investors participating in a public offering and raised an aggregate of $2.35 million, with net proceeds after deducting the fees and expenses of approximately $1.9 million.

"The first quarter saw continued progress in our important programs despite high volatility in the markets and funding constraints," stated Lewis H. Bender, Intensity Founder, President, and CEO. "Several patients in our sarcoma study had their first follow-up scans, which showed high levels of necrosis in the injected tumors. Site contracting, site activation and patient enrollment were increasing nicely. However, due to cash needs, we made the necessary decision to pause the Phase 3 sarcoma enrollment and site activation until additional funding becomes available. We are working closely with our vendors and sites to treat those patients enrolled in INVINCIBLE-3, while maintaining the pharmacovigilance, site monitoring and the study database. Meanwhile, our partners SAKK and Unicancer will continue to work with the leading hospitals in Switzerland and France to seek patients for our breast cancer trial, INVINCIBLE-4. We believe in the potential for our drug to positively impact the lives of metastatic sarcoma and presurgical breast cancer patients worldwide. As cancer deaths increase, new and improved alternatives to current therapies are needed now more than ever."

First Quarter 2025 Financial Results

Research and development expenses were $2.2 million for the three months ended March 31, 2025, compared to $2.8 million for the same period in 2024. Clinical trial expenses increased marginally by $0.1 million due to the ongoing site initiations and patient enrollment of the INVINCIBLE-03 Study. Contract manufacturing costs declined by $0.2 million, as there were no manufacturing batches of INT230-6 in the first quarter of 2025. In addition, stock-based compensation was $0.4 million lower as no new equity grants were awarded in the first quarter of 2025.

General and administrative expenses were $1.2 million for the three months ended March 31, 2025, compared to $1.9 million for the same period in 2024. Legal, audit and other expenses decreased as a result of cost saving from the integration of new systems in the administrative areas. In addition, stock-based compensation was $0.3 million lower as no new equity grants were awarded in the first quarter of 2025.

Overall, net loss was $3.3 million for the three months ended March 31, 2025, compared to a net loss of $4.6 million for the three months ended March 31, 2024.

As of March 31, 2025, cash and cash equivalents totaled $0.9 million.

About INT230-6
INT230-6, Intensity’s lead proprietary investigational product candidate, is designed for direct intratumoral injection. INT230-6 was discovered using Intensity’s proprietary DfuseRx℠ technology platform. The drug is comprised of two proven, potent anti-cancer agents, cisplatin and vinblastine, and a penetration enhancer molecule (SHAO) that helps disperse potent cytotoxic drugs throughout tumors for diffusion into cancer cells. These agents remain in the tumor, resulting in a favorable safety profile. In addition to local disease control and direct tumor killing, INT230-6 causes a release of a bolus of neoantigens specific to the malignancy, leading to immune system engagement and systemic anti-tumor effects. Importantly, these effects are mediated without immunosuppression which often occurs with systemic chemotherapy.

On May 13, 2025 Instil Bio, Inc. ("Instil") (Nasdaq: TIL), a clinical-stage biopharmaceutical company focused on developing a pipeline of novel therapies, reported its first quarter 2025 financial results and provided a corporate update (Press release, Instil Bio, MAY 13, 2025, View Source [SID1234652970]).

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Recent Highlights:

ImmuneOnco’s Phase 1b/2 trial of AXN-2510/IMM2510 in combination with chemotherapy in 1L NSCLC in China is ongoing and ImmuneOnco anticipates initial clinical data from first-line NSCLC patients in 2H 2025.
U.S. clinical study of AXN-2510/IMM2510 in combination with chemotherapy in 1L NSCLC anticipated to commence before the end of 2025: Instil anticipates initiating a U.S. clinical trial of AXN-2510/IMM2510 in combination with chemotherapy for 1L NSCLC patients before the end of 2025, assuming the necessary regulatory approvals are obtained.
First Quarter 2025 Financial and Operating Results:

As of March 31, 2025, Instil had $111.8 million in total cash, cash equivalents, restricted cash, marketable securities and long-term investments, which consisted of $15.4 million in cash and cash equivalents, approximately $1.0 million in restricted cash, $88.3 million in marketable securities and $7.2 million in long-term investments, compared to $115.1 million in total cash, cash equivalents, restricted cash and marketable securities, which consisted of $8.8 million in cash and cash equivalents, $1.8 million in restricted cash, and $104.5 million in marketable securities, as of December 31, 2024. Instil expects that its cash, cash equivalents, marketable securities and long-term investments as of March 31, 2025 will enable it to fund its current operating plan beyond 2026.

Research and development expenses were $5.4 million for the three months ended March 31, 2025, compared to $7.3 million for the three months ended March 31, 2024.

General and administrative expenses were $9.1 million for the three months ended March 31, 2025, compared to $12.4 million for the three months ended March 31, 2024.

Restructuring and impairment charges were $16.1 million for the three months ended March 31, 2025, compared to $4.3 million for the three months ended March 31, 2024.

Net loss per share, basic and diluted were $4.32 for the three months ended March 31, 2025, compared to $3.74 for the three months ended March 31, 2024. Non-GAAP net loss per share, basic and diluted were $1.32 for the three months ended March 31, 2025, compared to $2.39 for the three months ended March 31, 2024.

Note Regarding Use of Non-GAAP Financial Measures

In this press release, Instil has presented certain financial information that has not been prepared in accordance with U.S. generally accepted accounting principles ("GAAP"). These non-GAAP financial measures include non-GAAP net loss and non-GAAP net loss per share, which are defined as net loss and net loss per share, respectively, excluding non-cash stock-based compensation expense and restructuring and impairment charges. Instil believes that these non-GAAP financial measures, when considered together with the GAAP figures, can enhance an overall understanding of Instil’s financial performance. The non-GAAP financial measures are included with the intent of providing investors with a more complete understanding of Instil’s operating results. In addition, these non-GAAP financial measures are among the indicators Instil’s management uses for planning purposes and to measure Instil’s performance. These non-GAAP financial measures should be considered in addition to, and not as a substitute for, or superior to, financial measures calculated in accordance with GAAP. The non-GAAP financial measures used by Instil may be calculated differently from, and therefore may not be comparable to, non-GAAP financial measures used by other companies. Please refer to the below reconciliation of these non-GAAP financial measures to the comparable GAAP financial measures.

On May 13, 2025 INOVIO (NASDAQ: INO), a biotechnology company focused on developing and commercializing DNA medicines to help treat and protect people from HPV-related diseases, cancer, and infectious diseases, reported its financial results for the first quarter of 2025 and provided an update on recent company developments (Press release, Inovio, MAY 13, 2025, View Source [SID1234652969]).

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"I’m pleased to confirm that we remain on track to submit our BLA for INO-3107 this year. As previously stated, our goal is to begin rolling submission in mid-2025, complete the submission in the second half of 2025 and receive file acceptance from the FDA by year end. If we receive priority review, it could allow for a PDUFA date in mid-2026," said Dr. Jacqueline Shea, INOVIO’s President and Chief Executive Officer. "We continue to focus our efforts and resources toward bringing this important product candidate to patients eager for a non-surgical therapeutic option to treat this devastating disease. Based on market research, we believe INO-3107 could be the preferred product for patients and providers, if approved. Beyond INO-3107, we are excited about the recently announced promising data from a proof-of-concept Phase 1 clinical trial with our next-generation DMAb technology, as well as the potential of our entire DNA medicines pipeline."

Operational Highlights

INO-3107 – Recurrent Respiratory Papillomatosis (RRP)
The DV testing for INO-3107 has been initiated and is anticipated to be completed in the first half of 2025. INOVIO plans to begin rolling submission of the BLA in mid-2025 under FDA’s accelerated approval program, subject to FDA concurrence, with the goal of completing the submission in the second half of 2025 and receiving FDA acceptance of the submission by the end of the year. FDA has previously awarded breakthrough therapy designation for INO-3107 and INOVIO plans to request priority review of its BLA, which if granted would allow for an FDA approval decision (PDUFA date) in mid-2026.

INOVIO is conducting ongoing market research with physicians, patients and payors to support its commercial readiness plans. Additionally, clinical and immunology data from a Phase 1/2 trial was published in the peer-reviewed scientific journal Nature Communications in February 2025 and longer-term follow up data was submitted to another peer-reviewed journal for publication. INOVIO has presented key efficacy, safety, immunological and durability data from the Phase 1/2 trial at a number of scientific conferences, including the following:

National HPV Conference (April 15)
World Vaccine Congress (April 21)
Festival of Biologics (April 23)
European Laryngological Society (ELS) Annual Congress (May 9)
American Society of Gene and Cell Therapy (May 13)
On May 14th INOVIO will also be presenting at the American Broncho-Esophagological Association Combined Otolaryngology Spring Meeting (ABEA/COSM), the largest US national meeting for otolaryngologists, the specialist physicians who treat the majority of RRP patients.

Available abstracts are posted to INOVIO’s website following presentations.

DNA-Encoded Monoclonal Antibodies (DMAbs)
In the first quarter, INOVIO and its collaborators announced top-line interim results from an ongoing Phase 1 proof-of-concept trial evaluating its DMAb technology. Additional data from this trial will be presented at the annual meeting of the American Society of Gene and Cell Therapy in May. The data is also anticipated to be published in a peer-reviewed journal. As previously announced, the interim results are currently available in preprint form on Research Square. In the trial, which used monoclonal antibodies against COVID-19 as proof-of-concept targets, 100% (24/24) of participants who reached week 72 maintained biologically relevant levels of DMAbs, confirming the durability of in vivo antibody production. Notably, no participant developed anti-drug antibodies, a common challenge observed in other gene-based delivery platforms, such as adeno-associated virus-mediated antibody expression.

First Quarter 2025 Financial Results

Research and Development (R&D) Expenses: R&D expenses for the three months ended March 31, 2025, decreased to $16.1 million from $20.9 million for the same period in 2024. The decrease was primarily the result of lower drug manufacturing and immunology expenses related to INO-3107, lower contract labor expenses and lower expensed inventory, partially offset by higher engineering professional and outside services related to our device development, among other variances.

General and Administrative (G&A) Expenses: G&A expenses decreased to $9.0 million for the three months ended March 31, 2025 from $10.6 million for the same period in 2024. The decrease was primarily related to a decrease in legal expenses and employee and consultant stock-based compensation, among other variances.

Total Operating Expenses: Total operating expenses decreased to $25.1 million for the three months ended March 31, 2025 from $31.5 million for the same period in 2024.

Net Loss: Net loss for the three months ended March 31, 2025 decreased to $19.7 million, or $0.51 per basic and diluted share, from a net loss of $30.5 million, or $1.31 per basic and diluted share, for the three months ended March 31, 2024.

Shares Outstanding: As of March 31, 2025, INOVIO had 36.7 million common shares outstanding and 51.3 million common shares outstanding on a fully diluted basis, after giving effect to the exercise, vesting, and conversion, as applicable, of its outstanding common stock warrants, including pre-funded warrants and stock options, restricted stock units and convertible preferred stock.

Cash, Cash Equivalents and Short-term Investments: As of March 31, 2025, cash, cash equivalents and short-term investments were $68.4 million, compared to $94.1 million as of December 31, 2024.
INOVIO’s balance sheet and statement of operations are provided below. Additional information is included in INOVIO’s quarterly report on Form 10-Q for the quarter ended March 31, 2025, which can be accessed at: View Source

Cash Guidance
INOVIO estimates its current cash, cash equivalents and short-term investments balances to support the company’s operations into the first quarter of 2026. This projection includes an operational net cash burn estimate of approximately $22 million for the second quarter of 2025. These projections do not include any further capital-raising activities that INOVIO may undertake.

Conference Call / Webcast Information
INOVIO’s management will host a live conference call and webcast with slides at 4:30 p.m. ET today to discuss INOVIO’s financial results and provide a general business update. The live webcast and replay may be accessed by visiting INOVIO’s website at View Source

On May 13, 2025 Immatics N.V. (NASDAQ: IMTX, "Immatics" or the "Company"), a clinical-stage biopharmaceutical company active in the discovery and development of T cell-redirecting cancer immunotherapies, reported a business update and announced financial results for the quarter ended March 31, 2025 (Press release, Immatics, MAY 13, 2025, View Source [SID1234652968]).

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"Our focus in the first quarter of 2025 was led by the execution of our SUPRAME Phase 3 clinical trial in melanoma as well as our other clinical-stage PRAME product candidates," said Harpreet Singh, Ph.D., CEO and Co-Founder of Immatics. "At the upcoming ASCO (Free ASCO Whitepaper) Annual Meeting, we will present another Phase 1b clinical update on our PRAME cell therapy, IMA203, in melanoma with substantially longer follow-up. We also look forward to providing clinical trial updates for our cell therapy and bispecific programs later this year, highlighting the potential of our therapies in and beyond melanoma. We maintain a strong cash position, enabling us to rapidly advance the development of all our clinical programs, with a specific focus on progressing IMA203 toward commercialization and delivering this highly differentiated PRAME therapy to cutaneous and uveal melanoma patients with unmet medical needs as quickly as possible."

First Quarter 2025 and Subsequent Company Progress

PRAME Programs

IMA203 PRAME Cell Therapy
IMA203 is Immatics’ lead PRAME cell therapy, currently being evaluated in a Phase 3 trial (SUPRAME) in patients with previously treated advanced melanoma. IMA203 has the potential to become the first PRAME therapy to enter the market. In parallel, Immatics is preparing its in-house, state-of-the-art cell therapy manufacturing facility to serve its planned commercial supply. As part of maximizing the PRAME cell therapy opportunity, Immatics plans to expand IMA203 into uveal melanoma through the ongoing Phase 1b clinical trial. The current addressable patient population of PRAME/HLA-A*02:01-positive 2L unresectable or metastatic cutaneous melanoma in the US and EU52 is ~7,300 plus ~1,300 uveal melanoma patients in the US and EU5.

Phase 3 trial, SUPRAME, for IMA203 in previously treated, advanced cutaneous melanoma

Based on the positive Phase 1b clinical data, Immatics has advanced its PRAME cell therapy, IMA203, into a randomized-controlled Phase 3 clinical trial, SUPRAME, evaluating the efficacy, safety and tolerability of IMA203 TCR T-cell therapy vs. investigator’s choice of treatment in patients with unresectable or metastatic cutaneous melanoma who have received prior treatment with a checkpoint inhibitor.
Primary endpoint for seeking full approval will be blinded independent central review ("BICR")-assessed (RECIST v1.1) progression-free survival (PFS). Secondary endpoints for the trial include objective response rate (ORR), safety, duration of response (DOR), overall survival (OS) and patient-reported outcomes.
The trial will be conducted internationally with approximately 50 sites in the US and Europe.
Patient enrollment and randomization for the trial was initiated in early 2025 and is expected to be completed in 2026. In April 2025, Immatics received regulatory approval from the German regulatory authority, Paul-Ehrlich-Institute (PEI), to commence the IMA203 SUPRAME Phase 3 trial in Germany.
A pre-specified interim data analysis will be triggered upon the occurrence of a defined number of events for PFS (progressive disease or death)3, anticipated to occur after approximately 200 patients. Immatics aims to submit a Biologics License Application (BLA) in 1Q 2027 for full approval.
IMA203 PRAME cell therapy development is supported by the FDA RMAT designation. Advantages of the RMAT designation (which includes all benefits of Breakthrough Therapy designation) include potential priority review of the BLA and frequent interactions with the US FDA as an opportunity to expedite development and review.
A trial-in-progress poster on SUPRAME will be presented in a poster presentation by the SUPRAME lead principal investigator, Jason Luke, MD, FACP, FASCO, at the 2025 ASCO (Free ASCO Whitepaper) Annual Meeting on June 2, 2025.

Phase 1b trial for IMA203 PRAME cell therapy in solid tumors with a focus on uveal melanoma

In addition to cutaneous melanoma, Immatics intends to expand the IMA203 opportunity to treat uveal melanoma patients and will continue to evaluate IMA203 in this patient population through the ongoing trial.
Updated data from the Phase 1b trial of IMA203 in metastatic melanoma with substantially longer follow-up compared to the last presentation in October 2024, and including data from additional uveal melanoma patients enrolled since then, will be highlighted by Martin Wermke, MD, in an oral presentation at the 2025 ASCO (Free ASCO Whitepaper) Annual Meeting on May 31, 2025.
In April 2025, Nature Medicine published a manuscript covering prior clinical results on IMA203. The publication includes data from 40 heavily pretreated patients with PRAME cancers, mostly treated during the Phase 1a dose escalation part of the trial.

Cell therapy manufacturing capabilities

The IMA203 PRAME cell therapy products are manufactured from a patient’s leukapheresis (with no surgery required) within 7-8 days, followed by 7-day QC release testing at >95% success rate4 to achieve the target dose (1-10×109 TCR T cells).
Immatics’ proprietary manufacturing process, timeline, capabilities and facility support late-stage clinical development and commercial cell therapy supply.
IMA203CD8 PRAME Cell Therapy (GEN2)
IMA203CD8 is the Company’s second-generation cell therapy product candidate targeting PRAME. Given its pharmacology profile, once the target dose is reached, the Company intends to pursue the clinical development of this product in multiple PRAME cancers, starting with gynecologic cancers.

Clinical data demonstrated enhanced pharmacology of IMA203CD8, which opens the possibility of addressing hard-to-treat solid tumor indications with both high- and medium-level PRAME copy numbers, such as ovarian cancer, uterine cancer, squamous non-small cell lung carcinoma, triple negative breast cancer and others.
Phase 1a dose escalation in solid tumors is ongoing to evaluate higher doses of IMA203CD8 with and without IL-2. As of today, patients are being treated with up to ~8 billion total GEN2 TCR T cells.
The next clinical trial update, which will report on the continued dose escalation in multiple PRAME cancers, including ovarian cancer patients treated at relevant doses, is planned in 2025.

IMA402 PRAME Bispecific

To expand the PRAME opportunity to additional solid cancer types and earlier lines of treatment, the Company is developing its half-life extended TCR Bispecific, IMA402. Upon delivering clinical proof-of-concept ("PoC") in last-line melanoma, Immatics plans to explore its potential in gynecologic cancers, NSCLC, breast cancer, and other solid tumor indications as well as earlier treatment lines of solid cancers, such as first-line (1L) cutaneous melanoma.

First clinical data from the early Phase 1a dose escalation trial demonstrated initial signs of dose-dependent and PRAME target expression-dependent clinical activity.
Phase 1a dose escalation at higher dose levels to determine the optimal therapeutic dose is advancing and currently ongoing at dose level 11 (12 mg).
The next Phase 1a clinical trial update with clinical data at relevant dose levels in second-line or later (2L) melanoma is planned in 2025.

Combination of IMA203 PRAME Cell Therapy and PRAME Adaptive Immune Modulating Therapy

In February 2025, the FDA granted IND clearance for a Phase 1 trial evaluating Immatics’ IMA203 PRAME cell therapy in combination with Moderna’s PRAME adaptive immune modulating therapy. The first-in-human, Phase 1a/1b trial is a multicenter, open-label, dose escalation/de-escalation (adaptive design) trial evaluating the safety, tolerability and efficacy of the combination therapy in an estimated 15 patients with advanced or recurrent cutaneous melanoma and synovial sarcoma. Immatics is responsible for conducting the Phase 1 trial. Each party retains full ownership of its investigational PRAME compound, and the parties will fund the clinical study on a cost sharing basis. In November 2024, Immatics presented preclinical proof-of-concept data at SITC (Free SITC Whitepaper) supporting this combination.

Other Programs

IMA401 MAGEA4/8 Bispecific
Immatics is further harnessing the potential of its proprietary bispecific platform to develop innovative therapeutics and unlock more cancer types. The Company’s half-life extended TCR Bispecific, IMA401 targeting MAGEA4/8, is progressing through a Phase 1 trial in patients with late-stage NSCLC, head & neck cancer, bladder cancer and other solid tumor indications, with the primary goal of developing this product candidate in earlier treatment lines.

Clinical proof-of-concept data from the Phase 1a dose escalation trial showed initial anti-tumor activity in multiple tumor types, including durable confirmed objective responses, a manageable tolerability profile and a half-life of 14+ days, which supported the switch to q2w dosing (once every two weeks).
The Phase 1a trial is ongoing and the Company continues to focus enrollment on indications with high MAGEA4/8 target expression, such as lung and head and neck cancer.
Dose refinement for IMA401 as monotherapy and in combination with a checkpoint inhibitor is ongoing. Through the combination, Immatics aims to generate relevant clinical data to position IMA401 as a combination therapy in earlier treatment lines.
The next update on IMA401 Phase 1a data, with a focus on head and neck cancer, is expected in 2025, and the Company plans to share data with a focus on non-small cell lung carcinoma in 2026.
Moderna Collaboration
Immatics generated regulatory support data for one of Moderna’s mRNA product candidates that leveraged Immatics’ XPRESIDENT and its bioinformatics and AI platform XCUBE. Pursuant to the Collaboration Agreement under the Database/Vaccine Program, Immatics received a milestone payment triggered by the initiation of the first Phase 1 clinical trial for the Moderna product candidate.

First Quarter 2025 Financial Results

Cash Position: Cash and cash equivalents as well as other financial assets total $588.1 million1 (€543.8 million) as of March 31, 2025, compared to $653.8 million1 (€604.5 million) as of December 31, 2024. The decrease is mainly due to ongoing research and development activities and includes unrealized foreign exchange translational losses of $14.2 million1 (€13.1 million).

Revenue: Total revenue, consisting of revenue from collaboration agreements, was $20.1 million1 (€18.6 million) for the three months ended March 31, 2025, compared to $32.8 million1 (€30.3 million) for the three months ended March 31, 2024. The decrease is mainly the result of the one-time revenue associated with the termination of the Genmab collaboration during the three months ended March 31, 2024.

Research and Development Expenses: R&D expenses were $45.3 million1 (€41.9 million) for the three months ended March 31, 2025, compared to $34.7 million1 (€32.1 million) for the three months ended March 31, 2024. The increase mainly resulted from costs associated with the advancement of the product candidates in clinical trials.

General and Administrative Expenses: G&A expenses were $13.1 million1 (€12.1 million) for the three months ended March 31, 2025, compared to $12.5 million1 (€11.6 million) for the three months ended March 31, 2024.

Net Profit and Loss: Net loss was $43.2 million1 (€39.9 million) for the three months ended March 31, 2025, compared to a net loss of $2.4 million1 (€2.2 million) for the three months ended March 31, 2024. The increase mainly resulted from lower revenue recognized and unrealized non-cash foreign exchange rate losses.

Full financial statements can be found in our Report on 6-K filed with the Securities and Exchange Commission (SEC) on May 13, 2025, and published on the SEC website under www.sec.gov.

Upcoming Investor Conferences

Bank of America Healthcare Conference, Las Vegas (NV) – May 13 – 15, 2025
Jefferies Global Healthcare Conference, New York (NY) – June 3 – 5, 2025
Cantor Global Healthcare Conference, New York (NY) – September 3 – 5, 2025

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