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:

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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])

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 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.

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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])

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).

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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])

On January 8, 2026 Allogene Therapeutics, Inc. (Nasdaq: ALLO), a clinical-stage biotechnology company pioneering the development of allogeneic CAR T (AlloCAR T) products for cancer and autoimmune disease, reported 2026 as a program-defining year for allogeneic CAR T, with multiple first-half clinical readouts expected to test, and potentially validate, whether off-the-shelf CAR T can be delivered at biologic-like scale, in real-world settings, across oncology and autoimmune disease.

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After nearly eight years of platform development and treatment of more than 200 patients across six clinical studies, Allogene has built an off-the-shelf CAR T platform designed to deliver clinical utility, broad patient access, predictable manufacturing, and scalable economics which are core requirements for cell therapy to move beyond a bespoke process toward routine medical practice.

"We believe 2026 is a program-defining year for allogeneic CAR T and Allogene with value-defining readouts and clinical maturity unmatched in the allogeneic field," said David Chang, M.D., Ph.D., President, Chief Executive Officer and Co-Founder of Allogene. "With multiple first-half clinical milestones, we aim to demonstrate that CAR T can be delivered at biologic-like scale in real-world settings."

A Biologic-Like CAR T Platform Built for Real-World Demand
The Company’s off-the-shelf approach is purpose-built seeking to deliver the attributes required for sustainable growth and broad patient access, including:

Rapid, on-demand availability
Consistent, predictable product performance
Simplified administration compatible with outpatient use and deployment beyond academic centers into community settings
Manufacturing scalability of approximately 30,000 – 60,000+ doses annually
Efficient cost-of-goods profile (<$10K – 20K/dose)

Together, these attributes will position Allogene’s platform to support broad deployment across hematologic malignancies, autoimmune disease, and solid tumors – enabling CAR T therapy to reach patients earlier, more reliably, and in care settings where most patients are treated.

Cema-Cel: Giving LBCL Patients a Second Chance at First-Line Success
Allogene’s lead program, cemacabtagene ansegedleucel (cema-cel), is being evaluated in the pivotal Phase 2 ALPHA3 trial, a randomized study designed to test whether early, MRD-guided consolidation with cema-cel can prevent recurrence of large B-cell lymphoma (LBCL).

ALPHA3 seamlessly integrates cema-cel as a "7th cycle" of first-line therapy, without altering existing first-line treatment workflows, enabling early, MRD-guided treatment intervention for patients at high risk of relapse. The trial is enrolling patients across both academic and community cancer centers to improve patient access as the majority of LBCL patients are treated in the community cancer setting in the US.

An early Q2 2026 interim futility analysis focused on MRD clearance represents the first program-defining test of whether early, MRD-guided allogeneic CAR T can prevent recurrence of lymphoma. A 25–30% improvement in MRD clearance versus observation could signal one of the most meaningful advances in LBCL since the introduction of rituximab, based on historical benchmarks and growing data linking MRD clearance to long-term outcomes.

ALLO-329: Purpose-Built Allogeneic CAR T for Autoimmune Disease with Built-In Lymphodepletion
ALLO-329 is a next-generation dual-targeted CD19/CD70 AlloCAR T incorporating Allogene’s proprietary Dagger technology, which provides built-in, targeted lymphodepletion by selectively depleting cells in the patient that are responsible for rejecting AlloCAR T products: activated CD70-positive T cells.

This approach could reduce or eliminate the need for conventional cytotoxic lymphodepletion and significantly expand access, especially for:

Younger patients and women of child-bearing age for whom cytotoxic lymphodepletion is problematic
Settings where rheumatologists, not oncologists, are the primary treating physicians
Patients with moderate disease where a streamlined treatment could improve adoption

The Phase 1 RESOLUTION trial, a 3+3 dose escalation study, is enrolling patients across multiple autoimmune indications, including systemic lupus erythematosus, lupus nephritis, scleroderma, and inflammatory myositis. The trial plans to test up to four cell dose levels from a starting cell dose of 20 million CAR T cells in two parallel cohorts (one with a low intensity lymphodepletion and one with no lymphodepletion).

Initial proof-of-concept data are expected by the end of 1H 2026. Expected to be included in the initial data release are early clinical outcome and supporting translational data covering disease-related biomarkers, CAR T expansion, and immune reconstitution from the first dose level (20 million CAR T cells) cohorts.

If successful, ALLO-329 could open one of the largest new markets in cell therapy, where scalable manufacturing, reduced toxicity, and accessibility to rheumatologists become critical competitive differentiators.

ALLO-316: TRAVERSE Trial Establishes CAR T Potential in Solid Tumors
ALLO-316 has demonstrated early, durable responses in heavily pretreated patients with renal cell carcinoma (RCC), representing one of the first credible signals that CAR T – autologous or allogeneic – may deliver meaningful benefit in solid tumors. The Phase 1 trial demonstrated:

Robust CAR T cell expansion following standard Flu/Cy-based lymphodepletion, providing proof-of-concept for the Dagger technology platform
31% confirmed ORR with a single ALLO-316 dose1 in patients with high CD70 expression, which represents ~2/3 of clear cell RCC
All responses were durable beyond 6 months after ALLO-316 with no further treatment2
The Company continues pathway exploration for its continued development

"Each of our programs represents a different frontier where our products can change the trajectory of disease," said Zachary Roberts, M.D., Ph.D., Executive Vice President of Research and Development and Chief Medical Officer. "Cema-cel has the potential to reshape first-line lymphoma treatment by reaching patients destined to suffer a cancer recurrence before they relapse. ALLO-329 is designed to bring CAR T into the autoimmune setting with a therapy that is scalable, precise, and potentially deliverable without traditional lymphodepletion. And ALLO-316 has shown promising activity in a metastatic solid tumor context – something many considered unattainable for cell therapy. What these programs collectively demonstrate is that allogeneic CAR T is no longer a theoretical platform. It is a clinical reality advancing across multiple major therapeutic areas."

Cash Runway into 2H 2027
The Company continues to expect its cash runway to extend into the second half of 2027, excluding any impact from potential business development activities.

Together, these catalysts position Allogene to enter 2026 with an increasingly differentiated platform, strengthening fundamentals and the potential to reshape multiple high-value therapeutic categories through scalable, real-world allogeneic CAR T.

(Press release, Allogene, JAN 8, 2026, View Source [SID1234661845])