On November 12, 2025 Immatics N.V. (NASDAQ: IMTX, "Immatics" or the "Company"), a clinical-stage biopharmaceutical company and the global leader in precision targeting of PRAME, reported updated Phase 1a dose escalation data from both product candidates in its TCR Bispecifics (TCER) pipeline, IMA402 PRAME Bispecific and IMA401 MAGEA4/8 Bispecific, as well as next steps for clinical development.

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"Our off-the-shelf TCR Bispecifics have a proprietary next-generation format with half-life extension that is designed to combine optimized tolerability and potent anti-tumor activity while supporting patient-convenient dosing," said Carsten Reinhardt, M.D., Ph.D., Chief Development Officer at Immatics. "We have now achieved clinical proof-of-concept for both product candidates and seen their potential to make a meaningful impact on patients with limited treatment options through deep and durable responses. We look forward to continuing to drive the development of our bispecifics to advance accessible, innovative therapies that can reach more patients and make a lasting difference in cancer care."

"Today marks the beginning of a new phase for Immatics, expanding our reach beyond cell therapy and establishing a leading position in the TCR Bispecifics field, with a clear commitment to advancing the clinical development of our bispecifics pipeline," said Harpreet Singh, Ph.D., CEO and Co-Founder of Immatics. "Building on these data, we are excited to evaluate our IMA402 PRAME Bispecific now across multiple targeted cancer patient populations with significant unmet treatment needs and in potentially synergistic combinations. We are especially enthusiastic about the potential for profound benefit by combining IMA402 with IMA401, our MAGEA4/8 Bispecific, in patients with squamous non-small cell lung cancer, a large, highly underserved and difficult-to-treat indication."

Carsten Reinhardt, M.D., Ph.D., and Harpreet Singh, Ph.D., will present the complete TCR Bispecifics dataset and next development steps during a conference call and webcast today, November 12, at 8:30 am EST/2:30 pm CET. The presentation is accessible on the ‘Events & Presentations’ page on the Investors & Media section of the Company’s website.

IMA402 PRAME Bispecific Phase 1a Dose Escalation Data Summary

Patient Population: Advanced metastatic solid tumors with no available treatment options

As of the data cutoff on September 26, 2025, 80 heavily pre-treated patients (median of three prior systemic treatments) with recurrent and/or refractory solid tumors1 were treated with escalating dose levels of IMA402 monotherapy ranging from 0.02 mg to 30 mg. The safety population includes all 80 patients treated with IMA402. 29 patients received doses in the recommended Phase 2 dose (RP2D range) (10 to 30 mg) and, thereof, 20 patients were efficacy-evaluable2, including 14 patients with melanoma (12 cutaneous, 1 uveal, 1 unknown primary), 3 patients with ovarian carcinoma and 3 patients with other solid cancers3.

Safety: Treatment with IMA402 showed favorable tolerability

IMA402 showed favorable tolerability across a wide dose range in the 80 patients treated. The most frequent treatment-related adverse events (AEs) were expected and transient lymphopenia, consistent with the mechanism of action, and low-grade cytokine release syndrome (CRS): Grade 1: 33%, Grade 2: 5%, Grade 3: 0%, Grade 4: 1%. No ICANS or IMA402-related Grade 5 events occurred. Tolerability across all doses was consistent with tolerability at the RP2D range.

Phase 1a dose escalation in the monotherapy setting has been completed. The maximum tolerated dose (MTD) has not been reached. The provisional RP2D range has been identified at 10 to 30 mg. The Phase 1b dose expansion is ongoing at two distinct doses within the RP2D range, and the evaluation of IMA402 in combination with an immune checkpoint inhibitor has been initiated.

Anti-tumor Activity and Durability: Deep and durable responses observed at RP2D range

IMA402 showed a clear dose-response relationship across three different dose groups.

Deep and durable responses at RP2D range (RECIST 1.1)

All
Indications Melanoma Ovarian
Carcinoma

cORR 30% (6/20) 29% (4/14) 2/3
mDOR,
mFU month Not reached
4.2 Not reached
7.3 Not reached
2.2
Tumor shrinkage 55% (11/20) 57% (8/14) 2/3
DCR (at week 6) 65% (13/20) 71% (10/14) 2/3
mDOR: median duration of response; mFU: median follow-up; DCR: disease control rate

For patients across all indications treated within the RP2D range early, promising progression-free survival (PFS) and overall survival (OS) were observed:

Median PFS was 4.8 months at a mFU of 6.8 months; 6-month PFS rate was 45%
Median iPFS4 was not reached at a mFU of 6.3 months; 6-month iPFS rate was 58%
Median OS was not reached at a mFU of 5.4 months; 1-year OS rate was 94%

Clinical Development Opportunities for IMA402 PRAME Bispecific

Based on the promising Phase 1a dose escalation data, Immatics is advancing its IMA402 PRAME Bispecific into Phase 1b dose expansion at two distinct doses to determine the final RP2D, both as a monotherapy and in combination with an immune checkpoint inhibitor with a focus on melanoma and gynecologic cancers in 2026. Depending on the outcomes of these Phase 1b cohorts, the Company would seek to convert existing Phase 1b cohorts into Phase 2 trials, which will then have the potential to become registration-directed. As part of its strategy to maximize the IMA402 opportunity, the Company is also exploring the option to initiate additional Phase 1b cohorts in 2026 to determine the monotherapy and combination potential of IMA402 with immune checkpoint inhibitors and standard of care in late as well as earlier treatment lines. As an additional opportunity, the Company is exploring the potential combination of IMA402 with IMA401 MAGEA4/8 in squamous non-small cell lung cancer (sqNSCLC) and potentially other solid tumor indications.

IMA401 MAGEA4/8 Bispecific Phase 1a Data Summary

Patient Population: Heavily pre-treated patients with a broad range of tumor types with no available treatment options

As of the data cutoff on September 26, 2025, 55 heavily pretreated patients (median of four prior systemic treatments) with recurrent and/or refractory solid tumors5 were treated with escalating dose levels of IMA401 ranging from 0.0066 mg to 2.5 mg with or without an immune checkpoint inhibitor (ICI, pembrolizumab). The safety population includes all 55 patients treated with IMA401 as a monotherapy (n=46) or in combination with pembrolizumab (n=9). 44 patients were treated with doses from 1 to 2.5 mg, and thereof 38 were evaluable for efficacy6. All efficacy-evaluable patients treated with IMA401 in combination with pembrolizumab (n=4) had progressed on prior immune checkpoint inhibitor treatments.

Safety: Treatment with IMA401 showed favorable tolerability at RP2D

The most frequent and relevant treatment-related adverse events (AEs) across all 55 patients treated with IMA401 were low-grade cytokine release syndrome (CRS) (24% G1, 11% G2, no ≥ Grade 3), mostly at the first step dose, expected and transient lymphopenia, consistent with the mechanism of action, as well as neutropenia, which was mostly transient, not re-occurring after resolution under continued treatment and well-manageable at the RP2D range of 1-2 mg. Notably, no ICANS was observed. The tolerability of IMA401 in combination with pembrolizumab is consistent with the tolerability of IMA401 monotherapy.

The maximum tolerated dose (MTD) has not been reached; three dose-limiting events were observed at 2.5 mg. The Phase 1a dose escalation has been completed, and the provisional RP2D range has been identified at 1-2 mg. At RP2D, the tolerability profile was favorable.

Anti-tumor Activity and Durability: Promising clinical activity and deep and durable responses were observed in patients with head and neck cancer, melanoma and lung cancer treated at ≥1 mg

Patients in three focus indications treated with ≥1 mg of IMA401 as a monotherapy or in combination with pembrolizumab demonstrated clinical activity:

Head and neck cancer: cORR of 25% (2/8), disease control rate of 63% (5/8)
Melanoma: cORR of 29% (2/7), disease control rate of 57% (4/7)
Squamous non-small-cell lung cancer: 1 partial response at first scan for a heavily pre-treated, ICI-resistant patient, 1 patient with stable disease for >4 months and overall survival of approximately 16 months, 1 patient with progressive disease with shrinkage of liver target lesions

The duration of all confirmed responses was longer than 6 months post treatment, with the longest response ongoing over 2 years in a patient with advanced cutaneous melanoma.

Clinical Development Opportunity for IMA401 MAGEA4/8 Bispecific

Consistent with Immatics’ focus on advancing its PRAME franchise, the Company is exploring IMA401 in combination with IMA402, starting with squamous non-small cell lung cancer (sqNSCLC). Based on the clinical proof-of-concept of both bispecific candidates, including the initial promising activity of IMA401 in head and neck cancer and sqNSCLC, as well as preclinical proof-of-concept data, Immatics is well-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. As over 90% of patients with sqNSCLC are positive for PRAME and/or MAGEA4/8, a potential IMA402 and IMA401 combination treatment could provide broad treatment coverage for this patient population. Approximately 60% of patients with sqNSCLC are positive for both targets, which could boost anti-tumor activity and counteract potential tumor escape mechanisms. The current addressable patient population for metastatic sqNSCLC in the United States and EU5 includes an estimated 40,000 patients per year.

(Press release, Immatics, NOV 12, 2025, View Source [SID1234659819])

On November 12, 2025 Ascendis Pharma A/S (Nasdaq: ASND) reported financial results for the third quarter ended September 30, 2025, and provided a business update.

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"With our achievements in the third quarter and year to date, Ascendis is making great progress toward achieving Vision 2030. The ongoing strong global launch of YORVIPATH is transforming our financial profile and, based on positive feedback from physicians and patients, we expect to continue to build on this momentum," said Jan Mikkelsen, Ascendis Pharma’s President and Chief Executive Officer. "With TransCon CNP now under FDA and EMA review, we are on the verge of bringing our third high-value medicine to patients, and we expect our engine for future innovation to drive sustainable growth for years to come."

Select Highlights & Anticipated 2025 Milestones

TransCon PTH:
(palopegteriparatide, marketed as YORVIPATH)
YORVIPATH revenue for the third quarter of 2025 totaled €143.1 million, including a negative foreign currency impact of €3.6 million compared to the previous quarter.
Continued uptake from YORVIPATH in the U.S., with more than 4,250 unique patient enrollments and more than 2,000 prescribing health care providers as of September 30, 2025.
Outside the U.S., YORVIPATH is available commercially or through named patient programs in more than 30 countries.
Our strategic partner Teijin announced that YORVIPATH is now commercially available for prescription in Japan, expanding global access. In the third quarter, we recognized €12.9 million in milestone revenue related to the approval.
PaTHway60 trial, is ongoing as a single-arm safety and efficacy trial in adults with hypoparathyroidism to enable dose titration up to 60 mcg/day and is intended to support U.S. label expansion of YORVIPATH.
PaTHway Adolescent trial is planned to begin during the fourth quarter and is intended to support U.S. label expansion of YORVIPATH for the treatment of children with hypoparathyroidism, 12 to less than 18 years of age.
Presented pooled analysis of 3-year data from PaTHway and PaTH Forward trials at the American Society of Nephrology (ASN) Kidney Week 2025, reinforcing that treatment with TransCon PTH led to rapid and sustained improvements in kidney function in adults with hypoparathyroidism.

TransCon hGH:
(lonapegsomatropin, marketed as SKYTROFA)
SKYTROFA revenue for the third quarter of 2025 totaled €50.7 million, including a negative foreign currency impact of €1.6 million compared to the previous quarter.
The FDA approved our first label expansion for SKYTROFA in adult growth hormone deficiency, which represents the first of multiple additional label expansions we expect to pursue.
We initiated a basket trial for several established growth-hormone indications including idiopathic short stature (ISS), short stature homeobox-containing gene deficiency (SHOX deficiency), Turner syndrome, and small for gestational age (SGA).

TransCon CNP:
(navepegritide, FDA NDA and EMA MAA filed)
We recently completed our late-cycle meeting with the FDA, who accepted for priority review the New Drug Application (NDA) for the treatment of children with achondroplasia; Prescription Drug User Fee Act (PDUFA) goal date is November 30, 2025.
In Europe, our Marketing Authorisation Application (MAA) has been submitted and validated by the Committee for Medicinal Products for Human Use (CHMP) and is under review.
At the annual meeting of the American Society for Bone and Mineral Research (ASBMR), we presented new analyses from the pivotal ApproaCH Trial showing that children treated with TransCon CNP had improvements in the Physical Functioning domain of the Achondroplasia Child Experience Measure (ACEM-PF), with greatest benefits in younger children who had more severe genu varum (≥5°) at baseline, supporting benefits beyond linear growth.

TransCon CNP + TransCon hGH Combination Therapy
(navepegritide plus lonapegsomatropin)

Following a successful end-of-Phase 2 meeting with FDA, we plan to initiate a Phase 3 trial of TransCon CNP in combination with TransCon hGH this quarter.
Anticipate presenting 52-week data from the COACH Phase 2 trial of TransCon CNP + TransCon hGH in early 2026.
During the fourth quarter of 2025, we plan to submit an Investigational New Drug (IND) or similar to investigate TransCon CNP alone and in combination with TransCon hGH for the treatment of hypochondroplasia.

TransCon IL-2 β/γ
(onvapegleukin alfa)

In our IL-Believe trial, 70 patients with late-stage platinum-resistant ovarian cancer (PROC) (median 4 prior lines of therapy; 67% previously treated with at least 2 lines of taxane-containing therapy) have been enrolled. Data continued to suggest that TransCon IL-2 β/γ dosed every three weeks in combination with weekly paclitaxel is generally well-tolerated, with the majority of TransCon IL-2 β/γ-related treatment-emergent adverse events (TEAEs) being Grade 1 or 2 in severity.
We expect to provide median overall survival (OS) data for this cohort of 70 patients in the first quarter of next year as the dataset continues to mature.

Financial Update
Based on the continued growth of YORVIPATH, we achieved operating profitability. In the third quarter we recorded an operating profit of €11.0 million.
During the third quarter, our cash balance increased €45 million from €494 as of June 30, 2025, to €539 million as of September 30, 2025.

Third Quarter 2025 Financial Results
Total revenue for the third quarter of 2025 was €213.6 million, compared to €57.8 million during the same period in 2024. The year-over-year increase in revenue was primarily attributable to an increase in product revenue, which reflected a contribution of €134.6 million from YORVIPATH.

Total Revenue

(In EUR’000s) Three Months Ended
September 30,
Nine Months Ended
September 30,

2025
2024
2025
2024

Revenue
Commercial products 193,790 55,710 443,480 153,598
Rendering of services and clinical supply 6,134 1,272 13,228 9,637
Licenses 788 851 3,002 26,490
Milestones 12,922 — 12,922 —
Total revenue 213,634 57,833 472,632 189,725

Commercial Products Revenue

(In EUR’000s) Three Months Ended
September 30,
Nine Months Ended
September 30,

2025
2024
2025
2024

Revenue from commercial products
SKYTROFA 50,701 47,249 152,745 138,455
YORVIPATH 143,089 8,461 290,735 15,143
Total revenue from commercial products 193,790 55,710 443,480 153,598

Research and development costs for the third quarter of 2025 were €66.9 million, compared to €73.5 million during the same period in 2024. The decrease was driven by the completion of clinical trials and development activities within our Endocrinology Rare Disease pipeline.

Selling, general, and administrative expenses for the third quarter of 2025 were €113.4 million, compared to €69.8 million during the same period in 2024. The increase was primarily due to the continued impact from global commercial expansion, including launch activities for YORVIPATH.

Total operating expenses for the third quarter of 2025 were €180.3 million, compared to €143.4 million during the same period in 2024.

Operating profit for the third quarter of 2025 was €11.0 million primarily attributable to higher revenue from the launch of YORVIPATH in the U.S., partly offset by higher operating expenses.

Net finance expense for the third quarter of 2025 was €60.9 million, including non-cash remeasurement loss of financial liabilities of €47.2 million, compared to €2.9 million net finance income during the same period in 2024.

For the third quarter of 2025, Ascendis Pharma reported a net loss of €61.0 million, or €1.00 per share basic and diluted compared to a net loss of €99.2 million, or €1.72 per share basic and diluted for the same period in 2024.

As of September 30, 2025, Ascendis Pharma had cash and cash equivalents totaling €539 million compared to €560 million as of December 31, 2024. As of September 30, 2025, Ascendis Pharma had 61,695,211 ordinary shares outstanding, including 597,055 ordinary shares represented by ADSs held by the company.

Conference Call and Webcast Information
Ascendis Pharma will host a conference call and webcast today at 4:30 pm Eastern Time (ET) to discuss its third quarter 2025 financial results.

Those who would like to participate may access the live webcast here, or register in advance for the teleconference here. The link to the live webcast will also be available on the Investors & News section of the Ascendis Pharma website at View Source A replay of the webcast will be available in this section of the Ascendis Pharma website shortly after the conclusion of the event for 30 days.

(Press release, Ascendis Pharma, NOV 12, 2025, View Source [SID1234659839])

On November 12, 2025 SOTIO Biotech, a clinical-stage biopharmaceutical company owned by PPF Group, reported favorable preclinical results supporting the development of SOT106, its antibody-drug conjugate for the treatment of sarcoma, at the Connective Tissue Oncology Society (CTOS) Annual Meeting taking place November 12-15, 2025, in Boca Raton, FL.

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Data presented in SOTIO’s poster indicate that SOT106 is a potent and well-tolerated LRRC15-targeted ADC, showing strong potential for the treatment of sarcomas and other LRRC15-positive malignancies.

Specific results include:

SOT106 induces potent, antigen-specific cytotoxicity in vitro with nanomolar activity and a pronounced bystander effect.
In vivo, SOT106 drives dose-dependent tumor regression, including complete responses at 1 mg/kg, and surpasses benchmarks in both soft tissue sarcoma and osteosarcoma patient-derived xenograft (PDX) models, including those with low-to-medium LRRC15 expression and in orthotopic osteosarcoma.
In an exploratory non-human primate (NHP) study, SOT106 had a favorable pharmacokinetic profile and a high therapeutic index; dose-limiting toxicities aligned with known MMAE effects.
"Sarcomas continue to represent a significant unmet medical need, with limited therapeutic progress over the past several decades. LRRC15 is a clinically validated target broadly expressed across sarcoma subtypes, making it an ideal candidate for a differentiated ADC approach," said Amy Jensen-Smith, chief scientific officer of SOTIO. "These NHP data reinforce our confidence in SOT106’s therapeutic potential and mark a critical step toward delivering a novel treatment option for patients facing these aggressive diseases."

SOTIO is advancing SOT106 through IND-enabling studies toward an anticipated IND filing in Q4 2026. The company has additionally developed and validated a proprietary, highly sensitive, and specific LRRC15 immunohistochemistry assay to guide patient selection in upcoming clinical trials.

Poster presentation and Q&A details:

Poster Title: "Targeting leucine-rich repeat-containing protein 15 (LRRC15): SOT106 antibody-drug conjugate for soft tissue sarcoma and osteosarcoma treatment"
Presenter: Lenka Palova Jelinkova, Ph.D.
Date & Time: Thursday, Nov. 13, 2025, 5:30-6:30pm EST
Location: Grand Ballroom, The Boca Raton

Presentation materials will be available upon request following the live presentations.

(Press release, SOTIO, NOV 12, 2025, View Source [SID1234659858])

On November 12, 2025 Aprea Therapeutics, Inc. (Nasdaq: APRE) ("Aprea", or the "Company"), a clinical-stage biopharmaceutical company developing innovative treatments that exploit specific cancer cell vulnerabilities while minimizing damage to healthy cells, reported financial results for the third quarter ended September 30, 2025, and provided a business update. The Company reported continued clinical progress across both its WEE1 and ATR inhibitor programs and has cash runway into the fourth quarter of 2026.

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"We are pleased with the continued progress in our development programs, as the emerging data on both of our clinical assets demonstrate evidence of activity," said Oren Gilad, Ph.D., President and Chief Executive Officer of Aprea. "For APR-1051, our WEE1 kinase inhibitor, we’re encouraged by early signs of anti-tumor activity to date in the ongoing ACESOT-1051 trial, including 3 out of 4 patients with stable disease in the 100 mg once daily cohort. We have recently advanced into the 150 mg once daily cohort as dose escalation in this trial continues. For ATR-119, identifying the recommended Phase 2 dose for the once daily (QD) dosing provides a solid foundation for next-stage development, and we are now considering potential combination strategies, with radiation or checkpoint inhibitors, that could expand its clinical impact. These developments reinforce Aprea’s differentiated DDR approach and our commitment to helping patients with value creating clinical catalysts anticipated in 2026."

Key Business Updates and Potential Upcoming Key Milestones

ACESOT-1051: A Biomarker Focused, Phase 1 Trial of Oral WEE1 inhibitor, APR-1051

APR-1051 is a potent and selective small molecule WEE1 inhibitor designed to potentially solve tolerability challenges of the WEE1 class and has the potential to achieve improved clinical activity than other programs currently in development. APR-1051 is being advanced as a monotherapy in biomarker-defined cancers likely to respond to WEE1 inhibition. Among these, cancers over-expressing Cyclin E represent a high unmet medical need. Patients with Cyclin E over-expression have poor prognosis and, currently, lack effective therapies options.
APR-1051 is currently evaluated in the ongoing Phase 1 ACESOT-1051 (A Multi-Center Evaluation of WEE1 Inhibitor in Patients with Advanced Solid Tumors, APR-1051). Results from Dose Level 6 (100 mg once daily), show that 3 out of 4 patients achieved stable disease, per RECIST v1.1 in heavily pretreated gastrointestinal and gynecologic malignancies. Disease stabilization was observed in patients with FBXW7, CCNE1, and KRASG12V + TP53 alterations, molecular profiles known to drive replication stress and WEE1 dependency.
Following successful clearance of the 100 mg cohort, dose escalation has progressed to Dose Level 7 (150 mg once daily) with the goal of identifying doses that maximize therapeutic benefit while maintaining an acceptable safety profile. APR-1051 was manageable with mostly Grade 1 or 2 adverse events, which were mainly gastrointestinal events and fatigue.
A poster titled Early safety and efficacy of APR-1051, a novel WEE1 inhibitor, in patients with cancer-associated gene alterations: Updated data from ACESOT-1051 Phase 1 trial was presented on October 24, 2025at the AACR (Free AACR Whitepaper)-NCI-EORTC AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper). This poster summarizes preliminary results from the trial with a cutoff date of September 17, 2025. A copy is available on the Aprea corporate website here.
Pending additional data, future studies of ACESOT-1051 may evaluate APR-1051 in combination with checkpoint inhibitors to address unmet medical needs across distinct patient populations.
For more information, refer to ClinicalTrials.gov NCT06260514.
ABOYA-119: Ongoing Clinical Trial Evaluating ATR inhibitor, ATRN-119

ATRN-119 is a potent and highly selective first-in-class macrocyclic ATR inhibitor, designed and developed to be used in patients with tumors harboring mutations in DDR-related genes. Cancers with mutations in DDR-related genes represent a high unmet medical need. These patients often have a poor prognosis and currently lack effective therapeutics options.
ATRN-119 is being evaluated in the open-label Phase 1/2a clinical trial (ABOYA-119) as monotherapy in patients with advanced solid tumors having at least one mutation in a defined panel of DDR-related genes. As of September 8, 2025, 43 patients with advanced solid tumors have been enrolled.
Based on results to date, Aprea has determined the recommended Phase 2 dose (RP2D) to be 1,100 mg for the once daily dosing for ATRN-119.
Following RP2D determination Aprea is strategically pausing further enrollment in both once daily and twice daily monotherapy dosing arms of the ABOYA-119 trial to consider combination studies aimed at maximizing therapeutic benefits. Aprea is currently in discussions with leading academic centers to explore combining ATRN-119 with radiation in patients with HPV+ head and neck cancer, an indication where synergistic anti-tumor effects have been observed in preclinical data. Additional investigator-led studies evaluating ATRN-119 in combination with I/O agents and antibody-drug conjugates are also being explored.
A poster titled Updated data from ABOYA-119: A phase 1/2a trial of ATRN-119, a novel macrocyclic ATR inhibitor, in patients with advanced solid tumors harboring DNA damage trial was presented on October 24, 2025 at the AACR (Free AACR Whitepaper)-NCI-EORTC AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper). This poster summarizes preliminary results from the trial with a cutoff date of September 8, 2025. A copy can be found here.
For more information on ABOYA-119, please refer to clinicaltrials.gov NCT04905914.
Select Financial Results for the Third quarter Ended September 30, 2025

As of September 30, 2025, the Company reported cash and cash equivalents of $13.7 million compared to $22.8 million as of December 31, 2024. The Company believes its cash and cash equivalents as of September 30, 2025, will be sufficient to meet its currently projected operating expenses and capital expenditure requirements into the fourth quarter of 2026.
For the third quarter ended September 30, 2025, the Company reported an operating loss of $3.1 million, compared to an operating loss of $4.1 million in the third quarter of 2024.
Research and Development (R&D) expenses were $1.6 million for the quarter ended September 30, 2025, compared to $2.8 million for the third quarter of 2024. The decrease in R&D expenses was primarily related to higher expenses in 2024 related to study start up activities in preparation for enrollment of the first patient into ACESOT-105, our Phase 1 dose-escalation study of APR-1051, and lower expenses in 2025 related to the ABOYA-119 clinical trial to evaluate ATRN-119, our clinical-stage oral small molecule inhibitor of ATR.
General and Administrative (G&A) expenses were $1.5 million for the quarter ended September 30, 2025, compared to $1.6 million for the third quarter of 2024. The decrease in G&A expenses was primarily related to a decrease in insurance costs.
The Company reported a net loss of $3.0 million ($0.47 per basic share) on approximately 6.4 million weighted average common shares outstanding for the quarter ended September 30, 2025, compared to a net loss of $3.8 million ($0.64 per basic share) on approximately 5.9 million weighted average common shares outstanding for the comparable period in 2024.

(Press release, Aprea, NOV 12, 2025, View Source [SID1234659804])

On November 12, 2025 Immuneering Corporation (Nasdaq: IMRX) a clinical-stage oncology company focused on keeping cancer patients alive and helping them thrive, reported financial results for the third quarter ended September 30, 2025, and provided business and clinical updates.

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"The third quarter was truly transformational for Immuneering. We announced extraordinary overall survival data from our ongoing Phase 2a trial of atebimetinib in combination with modified gemcitabine/nab-paclitaxel (mGnP) in first-line pancreatic cancer and raised $225 million of cumulative financing on the strength of the data. I’m excited to say that the company is now funded into 2029 and, importantly, through the topline readout of our planned pivotal Phase 3 program in pancreatic cancer," said Ben Zeskind, Ph.D., CEO of Immuneering. "Today, we are also thrilled to share two remarkable examples of patients treated with atebimetinib in combination with FOLFIRINOX, one with a complete response, and another who had responded so well that they were able to pursue radiation and surgery with curative intent. Importantly, these patients are not among the ones we discussed in September. Looking ahead, we are excited to share updated survival data from our study of atebimetinib + mGnP in first-line pancreatic cancer patients in the first half of next year, and to begin dosing patients in our Phase 3 study of atebimetinib + mGnP by mid-next year. In summary, I have never been more excited about our company’s future, and our potential to help cancer patients live longer and feel better."

Corporate Highlights

Reported Extraordinary 86% Overall Survival at 9 Months in First-Line Pancreatic Cancer Patients Treated with Atebimetinib + mGnP: In September, the Company announced positive updated survival and safety data from its ongoing Phase 2a trial of atebimetinib in combination with mGnP in first-line pancreatic cancer patients (N=34), with 9 months median follow up. Immuneering reported an extraordinary 86% overall survival (OS) observed at 9 months. Atebimetinib (320mg dosed once-daily) + mGnP was reported to demonstrate a favorable tolerability profile, with only two categories of adverse events observed at the Grade 3 level in more than 10% of patients (neutropenia and anemia, both of which are categories commonly observed with standard of care chemotherapy).

Closed $175 Million Underwritten Public Offering and Concurrent $25 Million Private Placement to Sanofi: In September, the Company closed an underwritten public offering of 18,959,914 shares of its Class A common stock at an offering price of $9.23 per share. The gross proceeds from the public offering were approximately $175 million, before deducting underwriting discounts and commissions and offering expenses payable by Immuneering. The Company also announced that Sanofi purchased 2,708,559 shares of Immuneering’s Class A common stock at a purchase price of $9.23 per share, for gross proceeds of approximately $25 million before deducting placement agent discounts and commissions and placement expenses payable by Immuneering, in a separate private placement transaction that closed concurrently with the public offering.

Closed $25 Million Private Placement: In August, the Company announced that it had entered into a definitive securities purchase agreement for a private placement of securities to top-tier institutional and other accredited investors that resulted in up front gross proceeds to the Company of approximately $25 million, before deducting fees and expenses.

Announced Clinical Supply Agreement with Lilly to Evaluate Atebimetinib in Combination with Olomorasib: In August, the Company announced a clinical supply agreement with Eli Lilly and Company for its second-generation KRAS G12C inhibitor, olomorasib. The supply agreement intends to support the evaluation of Immuneering’s lead product candidate, atebimetinib, in combination with olomorasib in a planned Phase 2a clinical trial in patients with locally advanced or metastatic KRAS G12c-mutant non-small cell lung cancer (NSCLC) who have progressed on prior therapy. In February 2025, Immuneering announced a clinical trial agreement with Regeneron Pharmaceuticals similarly intended to evaluate atebimetinib in combination with the anti-PD-1 therapy Libtayo in a planned clinical trial in patients with advanced non-small cell lung cancer.

Granted U.S. Composition of Matter Patent for Atebimetinib: In July, the Company announced the United States Patent and Trademark Office (USPTO) granted the Company a composition of matter patent for atebimetinib. U.S. Patent No. 12,351,566, titled: "MEK Inhibitors and Therapeutic Uses Thereof", that includes claims to atebimetinib’s composition of matter. The patent’s term, which includes a patent term adjustment, is currently expected to expire in August 2042. The patent may also be eligible for patent term extension to recover a portion of the time required to fulfill regulatory approval requirements.

New Case Study of a Patient with Complete Response: A 71-year-old female patient with metastatic pancreatic cancer is being treated with atebimetinib in combination with FOLFIRINOX in the first-line setting in an ongoing Phase 2a study. The patient has been on treatment for approximately five months. During that time the patient’s target lesion, located in the liver, reduced steadily over the course of three scans to the point of being undetectable, for an unconfirmed complete response. The patient remains on treatment to date, feels extremely well, and has experienced improved quality of life and stable weight.

The investigator commented "It is very unusual to see a complete response with chemotherapy alone in a non-BRCA-mutated adenocarcinoma patient like this one. I believe atebimetinib has made a real difference here."

New Case Study of a Patient with Excellent Response Warranting Treatment with Curative Intent:
Dr. Gregory Botta, a medical oncologist who specializes in treating solid tumor cancers of the gastrointestinal system at the University of California San Diego (UCSD), described a 61-year-old female patient with metastatic pancreatic cancer treated with atebimetinib in combination with FOLFIRINOX in the first-line setting in an ongoing Phase 2a study. The treatment resulted in greater than 56% reduction in the primary tumor after 7 months to the point that treatment with radiation and surgery with curative intent was possible. The patient remains on atebimetinib adjuvant therapy and continues to do well with great quality of life and stable weight approximately 14 months after starting treatment. Dr. Botta commented "Rarely do metastatic pancreatic cancer patients improve to the point that surgery with curative intent is a possibility. I believe atebimetinib helped us convert this patient to a surgical candidate with curative intent – an outcome that I have rarely seen with chemotherapy alone – and today the patient has no radiological evidence of new disease."
"These case studies add to the growing body of evidence suggesting atebimetinib’s ability to produce transformative outcomes for cancer patients, including those with metastatic pancreatic cancer, and lend further robustness to the data we announced in September from a separate group of patients treated with atebimetinib in combination with mGnP chemotherapy," said Dr. Igor Matushansky, Chief Medical Officer of Immuneering.

Near-Term Milestone Expectations

Immuneering is planning for several near-term anticipated milestones related to atebimetinib, including to:

Q4 2025: Receive feedback from regulatory agencies and continue preparations to begin dosing patients in the pivotal trial of atebimetinib + mGnP
Q2 2026: Report updated circulating tumor DNA data on acquired alterations at a major scientific meeting
1H 2026: Report updated survival data from first-line pancreatic cancer patients treated with atebimetinib + mGnP, potentially at a major medical meeting
Mid-2026: Dose first patient in pivotal Phase 3 trial of atebimetinib in combination with mGnP in first-line pancreatic cancer
2H 2026: Dose first patient in trial of atebimetinib in combination with Libtayo in non-small cell lung cancer
Third Quarter 2025 Financial Highlights

Cash Position: Cash, and cash equivalents as of September 30, 2025 were $227.6 million, compared with $36.1 million as of December 31, 2024.

Research and Development (R&D) Expenses: R&D expenses for the third quarter of 2025 were $10.9 million, compared with $11.3 million for the third quarter of 2024. The decrease in R&D expenses was primarily attributable to decreases in clinical spend related to the IMM-6-415 program and decreases in personnel costs to support ongoing research and development activities, partially offset by higher clinical costs related to the Company’s lead atebimetinib program and spend related to other preclinical programs.

General and Administrative (G&A) Expenses: G&A expenses for the third quarter of 2025 were $4.5 million, compared with $4.0 million for the third quarter of 2024. The increase in G&A expenses was primarily attributable to increased public filing costs associated with the Company’s various financing efforts.

Net Loss: Net loss attributable to common stockholders was $15.0 million, or $0.38 per share, for the third quarter ended September 30, 2025, compared to $14.6 million, or $0.49 per share, for the third quarter ended September 30, 2024.

Financial Guidance

Based on cash, and cash equivalents as of September 30, 2025, and current operating plans, the Company expects its cash runway to be sufficient to fund operations into 2029.

Conference Call

Immuneering will host a conference call and live webcast today, November 12, 2025 at 4:30 pm ET. Individuals interested in listening to the live conference call may do so by dialing (800) 715-9871 in the U.S. or (646) 307-1963 for other locations and reference conference ID 7742025, or from the webcast link in the investors section of the company’s website: View Source A webcast replay will be available in the investor relations section on the company’s website for 90 days following completion of the call.

(Press release, Immuneering, NOV 12, 2025, View Source [SID1234659820])