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 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 STORM Therapeutics Ltd. (STORM), the clinical stage company pioneering cellular reprogramming through RNA modifications to treat disease, reported a strategic collaboration with Alida Biosciences Inc. (AlidaBio), a company at the forefront of epitranscriptomics and RNA modification analysis. STORM will utilize AlidaBio’s advanced EpiPlex and EpiScout next-generation sequencing (NGS) platforms to detect and quantitatively measure transcript-specific N6-methyladenosine (m6A) RNA modifications resulting from METTL3 inhibition. This will be achieved using STORM’s first-in-class METTL3 inhibitor, STC-15, which is the first small molecule drug targeting an RNA-modifying enzyme to enter human clinical trials.

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Post-transcriptional modification of RNA, including N6-methyladenosine (m6A), adds a crucial layer of regulation to RNA metabolism, influencing processes like synthesis, stability, maturation, transport, and translation. The METTL3/14 methyltransferase complex catalyzes the deposition of m6A, and inhibition of METTL3 reduces global m6A levels, disrupting RNA regulation. In this collaboration, STORM and AlidaBio will focus on the impact of METTL3 inhibition on RNA regulation, specifically m6A dynamics, in clinical samples from cancer patients treated with STC-15, currently in Phase 1/2 clinical trials.

In collaboration, the teams will correlate changes in m6A modifications at the transcript level with clinical response to treatment and identify baseline m6A features that could predict sensitivity to METTL3 inhibition. The collaboration aims to validate m6A-regulated genes and cell types affected by METTL3 inhibition, exploring epitranscriptomic biomarkers to guide patient selection and enrichment strategies for future clinical trials.

Dr. Eric Martin, Chief Development Officer of STORM Therapeutics, said: "AlidaBio has demonstrated exceptional expertise and leadership in the field of RNA modification analysis, particularly through the development of advanced NGS technologies capable of detecting key epitranscriptomic modifications in both healthy and diseased settings. Through this collaboration, our shared goal is to extend our understanding of transcript-specific m6A changes in relation to clinical benefit and patient response, to improve outcomes for cancer patients treated with STC-15."

Dr. Gudrun Stengel, Chief Executive Officer of AlidaBio, commented: "By applying the advanced features of our EpiPlex and EpiScout platforms, we aim to advance the clinical development and efficacy evaluation of STC-15 through comprehensive m6A biology analysis in patient samples. Our collaborative efforts are focused on generating deeper insights to ultimately deliver greater benefits for patients."

This collaboration highlights the growing importance of epitranscriptomics in drug development, combining targeted RNA-modifying enzyme inhibition with advanced molecular profiling to inform precision oncology strategies.

(Press release, STORM Therapeutics, JAN 8, 2026, View Source [SID1234661865])

On January 8, 2026 Alessa Therapeutics ("Alessa"), a clinical-stage biopharmaceutical company advancing novel localized drug delivery technology for the treatment of early-stage prostate cancers, reported that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for Enolen, the Company’s lead product candidate for the treatment of low to intermediate risk, localized prostate cancer.

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Fast Track designation is granted by the FDA to products that are developed to treat serious or life-threatening conditions and demonstrate the potential to address unmet medical needs. This designation is intended to facilitate development and expedite review of qualifying drugs. A drug that receives Fast Track designation may be eligible for more frequent meetings and communications with the FDA and rolling review of any application for marketing approval.

"Receiving Fast Track designation for Enolen is further evidence of the urgent need for new treatment options for early-stage prostate cancer. Patients living with prostate cancer deserve an alternative to active surveillance or being faced with the considerable negative side effects common with the more aggressive treatment options available today," said Cam Gallagher, President and Chief Executive Officer of Alessa Therapeutics. "We will continue to collaborate closely with the FDA to advance a new treatment option for men suffering not only from the disease itself, but who often face a heavy burden in deciding between not treating their cancer or pursuing therapies with significant health and lifestyle consequences."

Enolen utilizes novel anti-androgen eluting implants containing the FDA-approved prostate cancer compound enzalutamide. Enolen leverages Alessa’s proprietary local delivery technology which can deliver anti-androgens directly to diseased tissue in the prostate. This localized delivery can help eliminate the potential side effects of systemic anti-androgen and testosterone-lowering drugs, including sexual dysfunction, muscle mass loss, cognitive issues, metabolic syndrome and cardiovascular events.

Preclinical and clinical studies to date demonstrate that Alessa’s implant technology can deliver durable and continuous release of effective anti-cancer agents, achieving high local drug concentrations while minimizing the potential negative side effects which can result from systemic exposure.

Enolen is currently being studied in a Phase 1 trial evaluating its safety, tolerability and preliminary efficacy for localized sustained delivery of enzalutamide into the prostate. Alessa expects to present initial findings from the study in 2026.

(Press release, Alessa Therapeutics, JAN 8, 2026, View Source [SID1234661881])

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.

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"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

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CLN-978 (CD19xCD3 bispecific T cell engager): Rheumatoid arthritis (RA), systemic lupus erythematosus (SLE), and Sjögren’s disease (SjD)
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OUTRACE RA
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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.
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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.
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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.
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OUTRACE SLE
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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.
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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.
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OUTRACE SjD
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The Company has initiated patient dosing, and enrollment is ongoing in the 10-microgram dose cohort.
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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.

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Velinotamig (BCMAxCD3 bispecific T cell engager): Autoimmune diseases
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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

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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.
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In Q4 2026, the Company plans to initiate a Phase 1/2 combination study in frontline AML.
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Enrollment also continues in a parallel Phase 1 study in patients with AML and measurable residual disease (MRD) immediately following induction therapy.

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Zipalertinib (EGFR ex20ins inhibitor), collaboration with Taiho Oncology: EGFR ex20ins NSCLC
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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.
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Taiho expects to complete enrollment of the pivotal study REZILIENT3 in 1L EGFR ex20ins NSCLC in H1 2026.
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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])