On January 8, 2026 Cellectis (the "Company") (Euronext Growth: ALCLS – NASDAQ: CLLS), a clinical-stage biotechnology company using its pioneering gene editing platform to develop life-saving cell and gene therapies, reported its strategic priorities and key catalysts expected for 2026.

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"2025 was a transformational year for Cellectis, as we transitioned to a late-stage development allogeneic CAR-T company with the initiation of a pivotal Phase 2 trial for lasme-cel." said André Choulika, Ph.D., Chief Executive Officer of Cellectis. "As we enter 2026, we remain fully committed to executing our pivotal Phase 2 BALLI-01 trial for lasme-cel in ALL, with interim data expected in Q4, presenting the full Phase 1 data of the NATHALI-01 trial for eti-cel in NHL, and leveraging the momentum of our strategic partnership with AstraZeneca."

Allogeneic CAR-T Pipeline

Lasme-cel in r/r B-ALL (BALLI-01)

Following the initiation of the pivotal Phase 2 BALLI-01 clinical trial in October 2025, Cellectis expects to complete the first interim analysis in Q4 2026. This upcoming milestone (n=40) builds upon the encouraging Phase 1 clinical data presented at the Cellectis’ R&D Day, which highlighted:

Strong Efficacy: 68% overall response rate (ORR) with lasme-cel Process 2 (n=22), 83% at the recommended Phase 2 dose (RP2D) (n=12) and 100% in the target Phase 2 population (n=9). 56% complete remission or complete remission with incomplete hematologic recovery (CR/CRi) rate with ~80% of these patients achieving minimal residual disease (MRD)-negative status in the target Phase 2 population. 60% MRD- negative CR/CRi rate achieved in patients who relapsed following a prior CD22 targeted therapy.
Strong Survival Benefit: 14.8 months median overall survival (OS) in patients who achieved MRD-negative CR/CRi.
Favorable Safety Profile: lasme-cel was generally well tolerated, with a single case of grade 2 immune effector cell–associated hemophagocytic syndrome (IEC-HS), which resolved.
Eti-cel in r/r NHL (NATHALI-01)

Building on the preliminary Phase 1 data presented at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in December 2025, Cellectis is focused on maximizing the clinical impact of its dual-target CAR-T candidate:

Phase 1 interim Results: The NATHALI-01 clinical trial demonstrated an encouraging ORR of 88% and a CR rate of 63% at the current dose level, showcasing the potential of eti-cel in r/r NHL patients who have relapsed following multiple lines of therapy including, for most patients, an autologous CD19 CAR-T.
Q1 2026: Initiation of patient enrollment in the cohort with low dose interleukin-2 (IL-2) support to evaluate the potential to further enhance the already high response rates and durability of response in patients with r/r NHL.
Q4 2026: The Company expects to report the full Phase 1 dataset, including results from the IL-2 combination.
Strategic Partnerships

AstraZeneca

Activities are progressing under the Joint Research and Collaboration Agreement with AstraZeneca, which leverages Cellectis’ gene editing expertise and manufacturing capabilities to develop up to 10 novel cell and gene therapy products for areas of high unmet medical need, including oncology, immunology and rare genetic disorders.
Servier / Allogene

CD19: Servier’s sublicensee Allogene announced that the H1 2026 interim futility analysis from the pivotal Phase 2 ALPHA3 Trial with cema-cel in first-line consolidation large B-cell lymphoma remains on track. Under the Servier agreement, Cellectis is eligible to up to $340 million in development and sales milestones as well as low double-digit royalties on sales.
CD70: Allogene announced that the TRAVERSE trial in renal cell carcinoma has completed enrollment in its Phase 1b cohort, evaluating ALLO-316 in heavily pretreated patients, and that plans are ongoing to determine the next phase of the program.
Iovance

Iovance announced that clinical results for IOV-4001, a PD-1 inactivated tumor- infiltrating lymphocyte (TIL) cell therapy, in previously treated advanced melanoma patients are anticipated in the first quarter of 2026, and that other potential indications for IOV-4001 are also in development.
Cash Runway

Cellectis believes its cash, cash equivalents, and fixed-term deposits will be sufficient to fund its operations into H2 2027.
J.P. Morgan Healthcare Conference

Cellectis management will participate in the 44th Annual J.P. Morgan Healthcare Conference from January 12-15, 2026, and will be available for one-on-one investor meetings. To schedule a meeting, please contact Cellectis Investor Relations at [email protected]

(Press release, Cellectis, JAN 8, 2026, View Source [SID1234661848])

On January 8, 2026 KAHR Bio (KAHR or the Company), a clinical-stage biotechnology company developing DSP107, a first-in-class, bispecific 4-1BB–targeted, next-generation T-cell engager, reported topline results from its Phase 2a dose-expansion cohort in late-line metastatic microsatellite stable colorectal cancer (MSS-CRC). DSP107 was evaluated in combination with atezolizumab (Tecentriq), an anti–PD-L1 therapy. The combination demonstrated favorable safety, clinical evidence of antitumor activity, and extended survival, including in patients with liver metastases.

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KAHR also announced the closing of a $22 million round in equity financing. The equity investment was led by Flerie AB, Peregrine Ventures, Oriella Ltd. of the Consensus Business Group, aMoon Growth Fund, and the Cancer Focus Fund, with participation from certain additional existing investors and new investors including SPRIM Global Investments. The proceeds are expected to fully fund KAHR’s randomized, controlled Phase 2b trial of DSP107 in combination with atezolizumab versus fruquintinib (Fruzaqla) in fourth-line metastatic MSS-CRC. The trial was initiated in December 2025 following the U.S. Food and Drug Administration (FDA) investigational new drug (IND) clearance. In addition to the equity financing, KAHR has entered into a $10 million on-demand debt facility with SPRIM Global Investments, which the Company can draw down based on eligible research and development (R&D) activity under the Australian Government’s R&D tax rebate scheme. Additional equity commitments are under discussion as the Company continues to attract new investor interest.

The topline Phase 2a (NCT04440735) data demonstrated a median overall survival of 17.5 months, exceeding outcomes reported for currently approved therapies in this setting (6.4–10.8 months). Notably, approximately 75% of enrolled patients had liver metastases, a population historically refractory to immunotherapy. Across more than 130 patients treated with DSP107 to date in a variety of solid tumors and hematological malignancies, the therapy continues to demonstrate a favorable safety and tolerability profile.

Based on these encouraging results, KAHR has initiated a randomized, controlled, multicenter Phase 2b clinical trial in fourth-line metastatic, chemo-refractory MSS-CRC. The trial is expected to enroll at 18 sites across Australia and the United States, with the first patient having been enrolled in December 2025. Interim results are expected in late 2026, with topline data anticipated in the second half of 2027. Additional information about the study is available at clinicaltrials.gov (NCT07235293).

Anwaar Saeed, M.D., Chief of GI Oncology at the University of Pittsburgh and Co-Leader of the Cancer Therapeutics Program at UPMC Hillman Cancer Center, who co-led the Phase 2a trial said, "Observing efficacy with an immunotherapy approach in late line MSS-CRC patients with liver metastases is unexpected. DSP107’s mechanism is particularly suited to this setting as it utilizes CD47 overexpression on cancer cells to anchor a 4-1BB ligand to those cells, thereby attracting and activating T cells. CD47 expression increases in liver metastases following chemotherapy, creating a therapeutic window uniquely addressable by DSP107."

"Following these compelling topline results demonstrating anti-tumor activity and meaningful survival outcomes in heavily pretreated MSS-CRC patients, including those with liver metastases, we have made MSS-CRC our primary development focus and look forward to advancing the Phase 2b trial," said Yaron Pereg, Ph.D., Chief Executive Officer of KAHR.

Dr. Pereg added, "We highly appreciate the continued support from our existing and new investors. Their commitment reflects confidence in the clinical potential of DSP107 and the opportunity to meaningfully improve outcomes in MSS-CRC, a disease with a significant unmet medical need, and in our team’s ability to execute as we move toward our next milestones."

About DSP107
DSP107, KAHR Bio’s lead drug candidate, is a first-in-class, bispecific CD47×4-1BB targeting, next-generation T-cell engager. DSP107 utilizes tumor-expressed CD47 as an anchor, selectively binding CD47 on cancer cells while sparing red blood cells, thereby overcoming the safety challenges previously seen with other CD47-directed agents. Once bound, DSP107 converts the tumor’s immune-evasion signal into a potent 4-1BB co-stimulatory activation signal, recruiting and activating CD8 cytotoxic T cells and orchestrating engagement of both the innate and adaptive immune systems to generate a coordinated anti-tumor response. This approach is particularly relevant in colorectal cancer, where more than 70% of metastatic patients develop liver metastases that commonly upregulate CD47 following earlier-line chemotherapy. Unlike prior immunotherapy approaches in MSS-CRC, which have demonstrated limited benefit due to poor immune cell infiltration and low immunogenicity, DSP107 is designed to leverage tumor CD47 overexpression to enhance immune engagement within the tumor microenvironment, transforming it from immunosuppressive to immune-responsive and enabling productive anti-tumor immunity.

About Microsatellite Stable Metastatic Colorectal Cancer
Colorectal cancer (CRC) is one of the most common cancers worldwide and a leading cause of cancer mortality. Globally, CRC ranks among the top three most frequently diagnosed cancers, with approximately 1.9 million new cases and nearly 900,000 deaths annually, making it the second leading cause of cancer-related death and the third most common cancer overall. Among metastatic colorectal cancer (mCRC) cases, approximately 85–90 % are microsatellite stable (MSS). MSS-CRC is characterized by low tumor mutational burden and limited inherent immune activation, and as a result, tumors are typically unresponsive to current immunotherapies, including immune checkpoint inhibitors. Standard treatment for MSS-CRC continues to rely on cytotoxic chemotherapy, targeted agents, and VEGF inhibition. Despite advances in systemic therapy, there remains a significant unmet medical need for more effective treatment options, and ongoing research is focused on novel approaches, including immune-based and mechanism-driven combination strategies, to improve outcomes for patients with this challenging disease.

(Press release, KAHR Medical, JAN 8, 2026, View Source [SID1234661864])

On January 8, 2026 EpiBiologics, a leader in tissue-selective extracellular protein degradation, reported the completion of a $107 million Series B financing co-led by GV (Google Ventures) and Johnson & Johnson, through its corporate venture capital organization, Johnson & Johnson Innovation – JJDC, Inc (JJDC).

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Novartis Venture Fund (NVF), Aulis Capital, Avego BioScience Capital, and Samsara BioCapital joined JJDC as new investors. In addition to GV, existing investors Polaris Partners, Digitalis Ventures, Taiho Ventures, Vivo Capital, Codon Capital, and Mission BioCapital participated in the round.

"We’re delighted to work with this distinguished group of investors as we enter the next stage of EpiBiologics’ growth. This financing allows us to advance our pipeline of novel bispecific antibodies to selectively degrade disease-driving membrane and soluble targets in oncology and immunology," said Ann Lee-Karlon, Ph.D., Chief Executive Officer of EpiBiologics. "Our lead program, EPI-326, is moving rapidly to the clinic as a highly differentiated therapeutic to address substantial unmet needs for patients with EGFR-driven cancers."

EPI-326 is a tissue-selective bispecific antibody that degrades all oncogenic forms of EGFR, is mutation-agnostic, and overcomes limitations of existing EGFR therapies by localizing degradation to the tumor while sparing normal healthy tissue. In preclinical studies, EPI-326 drives strong and durable efficacy with favorable safety and pharmacokinetics, enabling both monotherapy and combination approaches for multiple cancer types.

EpiBiologics plans to initiate a first-in-human clinical trial of EPI-326 in early 2026 for non-small cell lung cancer (NSCLC) and head and neck squamous cell carcinoma (HNSCC). The company continues to build key capabilities as it moves towards the clinic and appointed two new executives in 2025, Eric Humke, M.D. Ph.D., Chief Medical Officer, and Aaron Mishel, Chief Financial Officer, who both have deep biopharma leadership expertise.

Concurrent with Series B financing, the company welcomes new Board members: Anika Gupta Vatsa, Ph.D. (GV), Laura Brass, Ph.D. (NVF), Gaurav Aggarwal, M.D. (Vivo), and a representative from JJDC. Nisa Leung (Aulis), Eric Pham, Ph.D. (Avego), and Mitchell Mutz, Ph.D. (Samsara) will join as Board observers.

"As an early investor, I’ve been impressed by EpiBiologics’ rapid scientific and operational progress as they’ve built the EpiTAC platform and portfolio in oncology, immunology, and beyond," said David Schenkein, M.D., General Partner at GV. "Anika and I are excited to co-lead this financing as the company translates this innovation into transformative medicines for patients."

(Press release, EpiBiologics, JAN 8, 2026, View Source [SID1234661880])

On January 7, 2026 Immuneering Corporation (Nasdaq: IMRX), a late-stage clinical oncology company focused on keeping cancer patients alive and helping them thrive, reported positive updated overall survival (OS) and safety data from its ongoing Phase 2a trial of atebimetinib (IMM-1-104) in combination with modified gemcitabine/nab-paclitaxel (mGnP) in first-line pancreatic cancer patients (N=34), with over 13 months median follow up time.

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"We are thrilled to report 64% overall survival at 12 months in first-line pancreatic cancer patients treated with atebimetinib in combination with mGnP," said Ben Zeskind, Ph.D., CEO of Immuneering. "The consistently strong separation observed between the overall survival in our clinical trial of atebimetinib in combination with mGnP in first-line pancreatic cancer patients and the benchmark for standard of care GnP from the MPACT study has now held at 6 months, 9 months, and 12 months. Having recently reached alignment on our planned pivotal Phase 3 clinical trial design with the FDA and EMA, with overall survival as our primary endpoint, we plan to dose the first patient in our MAPKeeper 301 pivotal trial in mid-2026, as we move to bring this new treatment option to patients as expeditiously as possible."

Extraordinary Overall Survival (OS) Observed at 12 Months in First-Line Pancreatic Cancer

Consistently Strong Separation Observed in Overall Survival from Standard of Care. Atebimetinib (320mg dosed once-daily) + mGnP demonstrated remarkable OS at 12 months (median follow up of 13.4 months) in first-line pancreatic cancer patients (N=34), with the median OS not yet reached as of the data cutoff date of December 15, 2025. The MPACT pivotal trial for the standard of care benchmark, gemcitabine/nab-paclitaxel, reported significantly lower OS as noted below.
64% OS observed at 12 months; standard of care benchmark reported a 35% OS at 12 months.
83% OS observed at 9 months; standard of care benchmark reported a ~47% OS at 9 months.
94% OS observed at 6 months; standard of care benchmark reported a 67% OS at 6 months.
Strong Separation Also Observed in Surrogate Endpoints from Standard of Care.
Confirmed Overall Response Rate (ORR) of 39% at 12 months; standard of care benchmark reported an ORR of 23%.
Disease Control Rate (DCR) of 81% at 12 months; standard of care benchmark reported a DCR of 48%.
Median Progression Free Survival (mPFS) of 8.5 months; standard of care benchmark reported a mPFS of 5.5 months.
Unless otherwise specified, all data are reported using a data cutoff date of December 15, 2025, from the same patient cohort (N=34) as previously reported in September 2025. The estimates of (and other references to) standard of care set forth above with respect to the 6- and 12-month follow-up data were reported directly from the publicly available third-party MPACT pivotal trial data for gemcitabine/nab-paclitaxel. The estimates of (and other references to) standard of care with respect to the nine-month follow-up data were extrapolated and reconstructed by the Company based on the publicly available third-party MPACT pivotal trial data for gemcitabine/nab-paclitaxel. The Company’s Phase 1/2a clinical trial of atebimetinib does not include a head-to-head comparison against any other agents, and caution should be exercised when comparing data across trials.

The Company believes these compelling updated OS data reflect the potential for a durable, compounding benefit with atebimetinib + mGnP in first-line pancreatic cancer patients.

Continued Favorable Tolerability Profile Observed
As of the data cutoff date of December 15 2025, atebimetinib (320mg dosed once-daily) + mGnP continued to demonstrate a favorable tolerability profile in first-line pancreatic cancer patients (N=34), 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 and were previously noted in the September 2025 update). No new safety signals were identified.

Continued Favorable Tolerability Profile in First-Line Pancreatic Cancer

Image 2
FOR ILLUSTRATIVE PURPOSES ONLY: No head-to-head clinical trial has been conducted evaluating atebimetinib and other candidates or products. Differences exist between trial designs, subject characteristics and other factors, and caution should be exercised when comparing data across studies. mGnP = 1,000 mg/m2 (Gem) + 125 mg/m2 (nab-Pac) days 1 & 15, every 4 weeks
FOR ILLUSTRATIVE PURPOSES ONLY: No head-to-head clinical trial has been conducted evaluating atebimetinib and other candidates or products. Differences exist between trial designs, subject characteristics and other factors, and caution should be exercised when comparing data across studies. mGnP = 1,000 mg/m2 (Gem) + 125 mg/m2 (nab-Pac) days 1 & 15, every 4 weeks

"Based on the exceptional data from the ongoing Phase 2a clinical trial of atebimetinib in combination with mGnP in first-line pancreatic cancer, we believe atebimetinib has the potential to deliver extraordinary overall survival with both durability and tolerability, two patient-centered essentials that oncologists have long struggled to balance," said Igor Matushansky, Chief Medical Officer at Immuneering. "Moving forward, in the first half of 2026 we plan to provide an update on an expanded cohort of over 50 first-line pancreatic cancer patients, which includes both the original 34 patients and additional patients we previously announced we planned to enroll, who are approaching sufficient median follow up time for presentation. We are excited to see that overall survival in the expanded cohort is trending consistently with what we have reported in the original 34 patients."

"The overall survival data reported for atebimetinib demonstrate its potential to be a better treatment option for patients with pancreatic cancer, for whom there is a need for more durable and better-tolerated treatments," said Dr. Meredith Pelster, Associate Director of Gastrointestinal Cancer Research for Sarah Cannon Research Institute, and investigator on the Phase 2a clinical trial. "Looking ahead, I share the enthusiasm of many in the field for the planned atebimetinib pivotal Phase 3 clinical trial and look forward to enrolling patients in the program."

Near-Term Milestone Expectations

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

Q2 2026: Report updated circulating tumor DNA data on acquired alterations at a major scientific meeting.
1H 2026: Report updated survival data from over 50 first-line pancreatic cancer patients treated with atebimetinib + mGnP.
Mid-2026: Dose first patient in pivotal Phase 3 clinical 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.
Conference Call

Immuneering will host a conference call and live webcast at 4:30 p.m. ET / 1:30 p.m. PT on January 7, 2026, to discuss the data and provide a business update. Individuals interested in listening to the live conference call may do so by dialing (800) 715-9871 for U.S callers and (646) 307-1963 for other locations and reference conference ID 8438896, or from the webcast link in the "investors" section of the company’s website at www.immuneering.com. A webcast replay will be available in the investor relations section on the company’s website for 90 days following the completion of the call.

About Atebimetinib
Atebimetinib is a Deep Cyclic Inhibitor (DCI), a new paradigm in targeted therapy. DCIs challenge the conventional model of sustained or continuous inhibition in oncology. Whereas most therapies are designed for sustained inhibition, driving cancer to adapt and develop resistance, so tumors shrink quickly but temporarily, DCIs are designed to pulse faster than tumors can adapt, so tumors shrink slowly but durably. Moreover, DCIs aim to restore full transient signaling to healthy cells, with the goal of leading to fewer adverse events. Atebimetinib targets MEK, a key control point in the MAPK pathway (RAS-RAF-MEK-ERK), which is pathologically activated in a majority of cancers, including approximately 97% of pancreatic cancers. Targeting MEK blocks a broader range of MAPK pathway alterations because it is further downstream, creating the potential for more durable benefit.

(Press release, Immuneering, JAN 7, 2026, View Source [SID1234661802])

On January 7, 2026 Pacira BioSciences, Inc. (Nasdaq: PCRX), the industry leader in its commitment to deliver innovative, non-opioid pain therapies to transform the lives of patients, reported that it will present at the 44th Annual J.P. Morgan Healthcare Conference at 11:15 AM PST (2:15 PM EST) on Wednesday, January 14, 2026. Live audio of the event can be accessed by visiting the "Events" page of the company’s website at investor.pacira.com. A replay of the webcast will also be available for two weeks following the event.

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(Press release, Pacira Pharmaceuticals, JAN 7, 2026, View Source [SID1234661817])