1stOncology™: Cancer Intelligence Service – Page 95 – 1stOncology is recognized as a Top 10 Global Pharma Analytic Provider

Cullinan Therapeutics Provides Corporate Update and Highlights Anticipated 2026 Milestones

On January 8, 2026 Cullinan Therapeutics, Inc. (Nasdaq: CGEM; "Cullinan"), a clinical-stage biopharmaceutical company accelerating potential first- or best-in-class, high-impact therapies in autoimmune diseases and cancer, reported a corporate update and shared anticipated business highlights for 2026.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

Schedule Your 30 min Free Demo!

"We have built strong momentum with CLN-978 and are pleased to share that we have completed multiple dose cohorts in our OUTRACE RA and OUTRACE SLE studies, and we have initiated dosing in our Sjögren’s disease study. This significant progress positions us to deliver the first company sponsored data with a CD19 T cell engager in autoimmune diseases. Throughout 2026, we will deliver data across all three indications, including important repeat dosing data in rheumatoid arthritis," said Nadim Ahmed, President and CEO of Cullinan Therapeutics.

"Our CLN-049 program continues to advance following the presentation of compelling efficacy and favorable safety data at ASH (Free ASH Whitepaper) 2025, which we believe enables an accelerated approval pathway. We plan to complete dose expansion in relapsed/refractory AML and TP53m AML to rapidly determine a recommended Phase 2 dose, while also initiating a frontline combination study this year. Additionally, 2026 marks a pivotal milestone for zipalertinib, as Taiho completes the rolling NDA submission in the beginning of the year, and completes enrollment in the frontline study REZILIENT3 in the first half of 2026. In summary, we are focused on generating multiple catalysts for our two high-priority T cell engager programs, CLN-978 and CLN-049, positioning us for a transformative year ahead."

Portfolio Highlights and Anticipated 2026 Milestones

Immunology

•
CLN-978 (CD19xCD3 bispecific T cell engager): Rheumatoid arthritis (RA), systemic lupus erythematosus (SLE), and Sjögren’s disease (SjD)
•
OUTRACE RA
o
Dose escalation is ongoing, and patients are currently being enrolled to the 30-microgram dose cohort. The 10- and 20-microgram dose cohorts are complete with no dose-limiting toxicities observed.
o
In Q2 2026, the Company plans to share initial data from the single target dose escalation portion of the study with a focus on safety and B cell depletion in peripheral blood and tissue, additional biomarker data, and preliminary clinical activity data.
o
In Q3 2026, the Company plans to share initial repeat dosing data, including B cell depletion in peripheral blood and tissue, additional biomarker data, and preliminary clinical activity data.
•
OUTRACE SLE
o
Dose escalation is ongoing, and patients are currently being enrolled in the 30-microgram dose cohort. The 10- and 20-microgram dose cohorts are complete with no dose-limiting toxicities observed.
o
In Q2 2026, the Company plans to share initial data from Part A (single target dose escalation) with a focus on safety and B cell depletion in peripheral blood, additional biomarker data, and preliminary clinical activity data.
•
OUTRACE SjD
o
The Company has initiated patient dosing, and enrollment is ongoing in the 10-microgram dose cohort.
o
In Q4 2026, the Company plans to share initial data from Part A (single target dose escalation) with a focus on safety and B cell depletion in peripheral blood and tissue, additional biomarker data, and preliminary clinical activity data.

•
Velinotamig (BCMAxCD3 bispecific T cell engager): Autoimmune diseases
o
In December 2025, Genrix Bio initiated a Phase 1 study in China in patients with autoimmune diseases, and initial clinical data from the study will be shared in Q4 2026. Cullinan intends to use the data generated to accelerate global clinical development of the program. Following the completion of the Genrix Bio Phase 1 study, Cullinan will conduct all further development of velinotamig in autoimmune diseases.
Oncology

•
CLN-049 (FLT3xCD3 bispecific T cell engager): Acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS)
o
In December 2025, CLN-049 received Fast Track designation for the treatment of relapsed/refractory AML from the U.S. FDA and, in an oral presentation at the 2025 ASH (Free ASH Whitepaper) Annual Meeting, the Company shared compelling clinical data in a heavily pretreated all-comer population of patients with relapsed/refractory AML. The Company plans to share an update from the dose escalation portion of the study in H2 2026.
o
In Q2 2026, the Company expects to initiate monotherapy dose expansion cohorts in patients with relapsed/refractory AML and TP53m AML. In Q4 2026, the Company expects to complete enrollment for dose expansion to determine the recommended Phase 2 dose (RP2D) for an expected single arm pivotal registrational trial.
o
In Q4 2026, the Company plans to initiate a Phase 1/2 combination study in frontline AML.
o
Enrollment also continues in a parallel Phase 1 study in patients with AML and measurable residual disease (MRD) immediately following induction therapy.

•
Zipalertinib (EGFR ex20ins inhibitor), collaboration with Taiho Oncology: EGFR ex20ins NSCLC
o
In November 2025, Taiho initiated a rolling submission of an NDA seeking accelerated approval of zipalertinib for the treatment of patients with relapsed EGFR ex20ins NSCLC. Taiho expects completion of the NDA submission in Q1 2026.
o
Taiho expects to complete enrollment of the pivotal study REZILIENT3 in 1L EGFR ex20ins NSCLC in H1 2026.
o
Cullinan is eligible to receive up to $130 million in payments for U.S. regulatory milestones and a 50/50 profit share in the U.S.

Cash Position and Cash Runway

Unaudited preliminary cash, cash equivalents, short- and long-term investments, and interest receivable were $439.0 million as of December 31, 2025. Consistent with prior guidance, Cullinan expects its cash resources to provide runway into 2029 under its current operating plan.

The Company expects to report its fourth quarter and full-year 2025 financial results in late February 2026 which will contain additional information required for a more complete understanding of the Company’s financial position and results of operations as of and for the year ended December 31, 2025.

(Press release, Cullinan Oncology, JAN 8, 2026, View Source [SID1234661850])

CORMEDIX THERAPEUTICS ANNOUNCES PRELIMINARY FOURTH QUARTER AND FULL YEAR 2025 RESULTS AND PROVIDES BUSINESS UPDATES

On January 8, 2026 CorMedix Therapeutics (Nasdaq: CRMD), a biopharmaceutical company focused on developing and commercializing therapeutic products for life-threatening diseases and conditions, reported its preliminary unaudited fourth quarter 2025 and full-year 2025 results, and provides guidance and an update on its business. These include the following key updates:

CorMedix announces preliminary, unaudited financial results for Q4 and FY 2025, including net revenue of approximately $127 million and $310 million, for Q4 2025 and FY 2025, respectively, FY 2025 Pro Forma net revenue(1) of approximately $400 million, and Q4 2025 adjusted EBITDA(2) in the range of $77 million to $81 million.
The Company reports preliminary unaudited cash and short-term investments, as of December 31, 2025, of approximately $148 million.
CorMedix expects clinical data from the Phase 3 ReSPECT study of REZZAYO (rezafungin for injection) in the prophylaxis of invasive fungal infection in adult patients undergoing allogeneic blood and marrow transplant in Q2 2026. In addition, the ongoing Phase 3 study of taurolidine/heparin catheter lock solution in TPN patients continues to enroll patients with targeted completion in early 2027.
The Company continues to see strong utilization and patient growth for DefenCath (taurolidine and heparin) by its outpatient dialysis organization customers. On July 1, 2026, DefenCath’s TDAPA reimbursement transitions into a post-TDAPA Add-On Adjustment, the calculation of which is determined by CMS. As a result of the methodology utilized by CMS, the level of reimbursement provided to institutions treating dialysis patients will significantly decline, and as a result, CorMedix expects a corresponding reduction to its net pricing for DefenCath in Q3 and Q4 of 2026. If CMS utilizes the same methodology to calculate the 2027 post-TDAPA Add-On Adjustment, which will be effective on January 1, 2027, CorMedix estimates the value of the Add-On Adjustment will be 3x – 5x higher than that granted for Q3 and Q4 of 2026, which the Company expects would result in higher DefenCath sales prices in 2027 relative to H2 2026.
CorMedix is introducing FY 2026 Revenue guidance of $300 million to $320 million, which includes $150 million to $170 million for DefenCath. 2026 DefenCath revenue guidance is heavily weighted toward H1 2026 and assumes modest utilization growth, which the Company expects will offset some of the price erosion over the course of the year. Based on the assumption of a higher net selling price in 2027 relative to H2 2026, the Company currently estimates full-year 2027 DefenCath sales in the range of $100 million to $140 million. DefenCath guidance for 2026 and 2027 assumes the maintenance of its current outpatient dialysis utilization run-rate with existing customers, and excludes any potential upside from new outpatient dialysis customers, increased utilization due to anticipated Medicare Advantage contracting, or any change in reimbursement due to pending TDAPA legislation.
In addition, management has operationalized synergies of approximately $35 million, on a full-year run rate basis, related to the acquisition of Melinta and is now focused on driving growth strategies for the business. The Company is estimating FY 2026 operating expenses of $145 million to $160 million, excluding non-cash items and one-time expenses, with the upper end of the spending range contingent upon positive Phase 3 data related to the ReSPECT study and a potential acceleration of enrollment in the DefenCath TPN study. Based on these estimates, CorMedix estimates FY 2026 Adjusted EBITDA in the range of $100 million to $125 million.
CorMedix is excited to announce that it will hold an Analyst Day on February 10, 2026, during which it will provide significant background on the medical need and the market potential for its key pipeline assets of REZZAYO in prophylaxis and DefenCath in TPN, as well as insights on the future strategic direction for the business. Details will be forthcoming.
Joseph Todisco, CorMedix Therapeutics CEO, commented, "I’m proud to announce our preliminary Q4 and FY 2025 results today, including surpassing our guidance for 2025. 2025 was a transformational year for CorMedix, as we evolved beyond a single-product company to an organization with multiple growth drivers and pipeline assets. We closed 2025 in a strong cash position, which we expect to further bolster over the coming year, providing the Company with financial flexibility to drive value for shareholders. With our new leadership team in place and multiple near-term pipeline catalysts, I am excited about the long-term potential for CorMedix Therapeutics."

The preliminary financial information presented in this press release is based on CorMedix’s current expectations and may be adjusted as a result of, among other things, the completion of our internal review process and the completion of customary annual audit procedures.

FY 2025 Unaudited Pro Forma Net Revenue was prepared by combining the estimated financial results and for CorMedix and Melinta for the full fiscal year ended December 31, 2025, without further adjustment, as if the transaction had closed on January 1, 2025.
Adjusted EBITDA is a non-GAAP financial measure and excludes non-cash items such as depreciation, amortization and stock-based compensation, and certain non-recurring items. The Company expects to provide a reconciliation of Adjusted EBITDA to the most comparable GAAP measure in its earnings release relating to the fourth quarter and full year 2025 financial results. Such reconciliation is not included in this release because CorMedix is currently finalizing certain amounts that would be required to be included in the U.S. GAAP measure or the individual adjustments for such reconciliation.

(Press release, CorMedix, JAN 8, 2026, View Source [SID1234661849])

Cellectis Announces 2026 Strategy and Catalysts

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.

"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])

ALX Oncology to Present at the 44th Annual J.P. Morgan Healthcare Conference

On January 8, 2026 ALX Oncology Holdings Inc. ("ALX Oncology"; Nasdaq: ALXO), a clinical-stage biotechnology company advancing a pipeline of novel therapies designed to treat cancer and extend patients’ lives, reported its participation in the 44th Annual J.P. Morgan Healthcare Conference in San Francisco. Chief Executive Officer Jason Lettmann and Chief Medical Officer Barbara Klencke will deliver a corporate presentation on Thursday, January 15, 2026, at 12:00 p.m. Pacific Time.

The live webcast of the J.P. Morgan fireside chat can be accessed by visiting the Investors section of ALX Oncology’s website at www.alxoncology.com under the Events section of the Events and Presentations tab. A replay of the webcast will be archived for up to 90 days following the fireside chat date.

(Press release, ALX Oncology, JAN 8, 2026, View Source [SID1234661847])

ALX Oncology Advances Separate Clinical Trials Evaluating Investigational CD47-Inhibitor Evorpacept and Novel EGFR-Targeted Antibody-Drug Conjugate ALX2004

On January 8. 2026 ALX Oncology Holdings Inc. ("ALX Oncology," Nasdaq: ALXO), a clinical-stage biotechnology company advancing a pipeline of novel therapies designed to treat cancer and extend patients’ lives, reported that the first patient has been dosed in the Company’s Phase 2 ASPEN-09-Breast trial evaluating its investigational CD47-inhibitor evorpacept. This trial will evaluate the combination of evorpacept with trastuzumab and physicians’ choice of chemotherapy in patients with HER2-positive metastatic breast cancer whose disease has progressed after ENHERTU (T-DXd).

Additionally, after successfully clearing the second dose cohort, the Phase 1 trial evaluating the Company’s epidermal growth factor receptor (EGFR)-targeted antibody-drug conjugate (ADC) ALX2004 for the treatment of EGFR-expressing solid tumors has begun enrolling patients in the third dose cohort at 4mg/kg. No dose-limiting toxicities were observed in the prior two dose cohorts.

"We are extremely pleased with the progress we are making on these clinical trials," said Jason Lettmann, Chief Executive Officer at ALX Oncology. "We believe both evorpacept and ALX2004 have the potential to fill significant gaps in the standard of care for many types of cancer."

Evorpacept is the first CD47 inhibitor to show substantial tumor response and a well-tolerated safety profile in a randomized trial. Data from this prior gastric cancer trial, ASPEN-06, show that evorpacept demonstrated benefit across all efficacy parameters in patients with HER2-positive disease and high CD47 expression levels. Research has demonstrated that increased CD47 expression is correlated with poor patient outcomes in many tumor types, including breast cancer.

The Phase 2 ASPEN-09-Breast clinical trial (NCT07007559) is a single-arm, open-label, multicenter study evaluating evorpacept plus trastuzumab and physicians’ choice of chemotherapy in 80 patients with HER2-positive breast cancer previously treated with ENHERTU (fam-trastuzumab deruxtecan-nxki), which was recently approved as first-line therapy. The trial will utilize participants’ CD47 expression levels as a biomarker to assess responses.

The primary endpoint of the trial is overall response rate (ORR) in patients who are confirmed HER2 positive by circulating tumor DNA (ctDNA). Key secondary endpoints are ORR in the HER2 ctDNA+ subpopulation by level of CD47 expression, clinical benefit rate (CBR), duration of response (DOR), progression-free survival (PFS) and overall survival (OS), and safety. ORR in the HER2 ctDNA-negative subpopulation is an exploratory endpoint. ALX Oncology anticipates sharing interim data from the trial in Q3 2026.

The ALX2004 Phase 1 clinical trial (NCT07085091) is a first-in-human, open-label, multicenter trial evaluating ALX2004 in participants with advanced or metastatic select EGFR-expressing solid tumors. The study consists of a Phase 1a dose escalation portion followed by optional dose exploration, and a Phase 1b dose expansion. The dose escalation portion of the trial is enrolling patients with previously treated advanced or metastatic non-small cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC), esophageal squamous cell carcinoma (ESCC) and colorectal cancer (CRC).

"Preclinical data suggest that ALX2004 has the potential to overcome the toxicity challenges associated with earlier generation EGFR-targeted ADCs," said Lettmann. "It is encouraging that, after clearing the second dose cohort in our Phase 1 trial at 2mg/kg, we are able to double the dosage to 4mg/kg in the third cohort."

ALX Oncology expects to provide an initial safety update from the Phase 1 ALX2004 trial during 1H 2026.

(Press release, ALX Oncology, JAN 8, 2026, View Source [SID1234661846])