On March 5, 2026 Immatics N.V. (NASDAQ: IMTX, "Immatics" or the "Company"), a clinical-stage biopharmaceutical company and the global leader in precision targeting of PRAME, reported a business update and announced financial results for the quarter and full year ended December 31, 2025.

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"Following a year of strong execution and data updates across our entire PRAME franchise, Immatics is entering 2026 with multiple high-impact milestones ahead, including advancing our PRAME cell therapy, anzu-cel, towards approval," said Harpreet Singh, Ph.D., Chief Executive Officer and Co-Founder of Immatics. "In parallel, we strive to expand our reach to more patients with our second-generation PRAME cell therapy, IMA203CD8, with meaningful data in gynecologic cancers expected this year, and with our PRAME bispecific IMA402, where we plan to report expanded clinical data supporting initiation of indication-specific expansion cohorts. In addition, we look forward to opening a new therapeutic avenue by initiating a combination study with IMA402 and IMA401, our MAGEA4/8 bispecific, in lung cancer. Above all, we remain focused on translating this positive momentum into transformative outcomes for patients with cancer."

Full Year 2025 and Subsequent Company Progress

PRAME Franchise – Cell Therapy

Anzu-cel (IMA203) PRAME Cell Therapy – First Market Entry in Advanced Melanoma
Anzu-cel (anzutresgene autoleucel), previously called IMA203, is Immatics’ lead PRAME cell therapy and is expected to be the Company’s first PRAME therapy to enter the market in advanced melanoma. The current addressable patient population for anzu-cel’s first target indications, second-line or later (2L) advanced cutaneous melanoma as well as metastatic uveal melanoma includes ~9,000 patients2.

Anzu-cel received Orphan Drug Designation as well as RMAT designation3 from the U.S. Food and Drug Administration (FDA) for the treatment of both cutaneous and uveal melanoma.

Phase 3 trial, SUPRAME, for anzu-cel (IMA203) in previously treated, advanced cutaneous melanoma

Immatics’ global, randomized, controlled, multi-center Phase 3 clinical trial, SUPRAME, is currently ongoing to evaluate the efficacy, safety and tolerability of anzu-cel PRAME cell therapy as monotherapy vs. investigator’s choice in patients with unresectable or metastatic cutaneous melanoma who have received prior treatment with a PD-1 immune checkpoint inhibitor.
SUPRAME is designed to be an adequate and well-controlled clinical trial intended to generate robust data to support regulatory approval of anzu-cel as Immatics advances this PRAME cell therapy.
Primary endpoint for seeking full approval is blinded independent central review ("BICR")-assessed (RECIST v1.1) progression-free survival (PFS). Secondary endpoints include overall survival (OS), objective response rate (ORR), safety and patient-reported outcomes measuring quality of life.
SUPRAME timelines remain unchanged. Pre-specified interim and final data analyses will be triggered upon the occurrence of a defined number of events for PFS (progressive disease or death). Interim and final analyses remain expected to be triggered in 2026 as planned, given current strong enrollment rate. As communicated previously and in line with general FDA guidance, data from the interim analysis is not intended to be published to protect the integrity of the clinical trial as long as enrollment remains ongoing.
The Company continues to expect BLA submission in the first half of 2027 and commercial launch of anzu-cel in the second half of 2027.
Patient recruitment is currently ongoing in North America and Europe.
Phase 1/2 trial for anzu-cel (IMA203) PRAME cell therapy in patients with advanced melanoma

Phase 1b data in patients with advanced melanoma were published at ASCO (Free ASCO Whitepaper) 2025 and a subset analysis in uveal melanoma was published at ESMO (Free ESMO Whitepaper) 2025, both showing favorable tolerability and strong clinical benefit of anzu-cel one-time infusion.
A Phase 2 cohort to treat approximately 30 additional metastatic uveal melanoma patients is ongoing and being conducted at select centers in the U.S. and Germany with expertise in uveal melanoma.
Data from the ongoing single-arm Phase 1b as well as Phase 2 trial in metastatic uveal melanoma are intended to support a potential label expansion for anzu-cel.
The next data update from the Phase 1/2 trial with ongoing follow-up of patients with cutaneous and uveal melanoma is planned for 2026.
Phase 1 combination trial for anzu-cel (IMA203) PRAME cell therapy and Moderna’s PRAME cell therapy enhancer, mRNA-4203, in patients with solid tumors

First patient dosed in Phase 1 dose escalation trial in 3Q 2025; the combination treatment has the potential to further enhance anti-tumor activity of anzu-cel, strengthen clinical outcomes and broaden the addressable patient population.
Each party retains full ownership of its investigational PRAME compound, and the parties fund the clinical study on a cost-sharing basis.
IMA203CD8 PRAME Cell Therapy (GEN2) – Expansion to all Advanced PRAME Cancers
IMA203CD8 is the Company’s second-generation PRAME cell therapy product candidate being developed with the goal of expanding into all advanced PRAME cancers. Given its enhanced pharmacology profile, once the target dose is reached, the Company intends to pursue the clinical development of this product candidate with a tumor-agnostic approach, starting with gynecologic cancers.

Updated Phase 1a dose escalation data presented at ESMO (Free ESMO Whitepaper)-IO 2025 Congress showed manageable tolerability as well as promising initial anti-tumor activity in PRAME-positive tumors at low median dose, including proof-of-concept data in ovarian carcinoma.
Results could support the positioning of IMA203CD8 to treat patients with PRAME cancers without post-infusion IL-2.
Immatics plans to present Phase 1a data with a focus on ovarian cancer at relevant doses at a major medical conference in the first half of 2026.
The Company is on track to complete Phase 1a dose escalation and determine recommended Phase 2 dose (RP2D) in 2026.
PRAME Franchise – Bispecifics

IMA402 PRAME Bispecific – Expansion to Earlier-Line PRAME Cancers

To expand the PRAME opportunity to earlier-line PRAME cancers, the Company is developing its off-the-shelf, next-generation, half-life extended TCR bispecific, IMA402, as a monotherapy or in combination with standard of care, with a focus on melanoma and gynecologic cancers. In addition, Immatics is exploring the potential combination of IMA402 with IMA401 MAGEA4/8 bispecific in squamous non-small cell lung cancer (sqNSCLC) and potentially other solid tumor indications.

In November 2025, Immatics announced clinical proof-of-concept for its IMA402 PRAME bispecific with updated data from the Phase 1a dose escalation trial in heavily pre-treated patients with solid tumors, including melanoma and ovarian cancer.
Immatics expects to determine the final RP2D and present a clinical data update from a larger patient population with a focus on melanoma and gynecologic cancers treated with IMA402 monotherapy or combination with an immune checkpoint inhibitor in the second half of 2026. Based thereon, the Company may seek to convert existing Phase 1b cohorts into Phase 2 trials, which may have the potential to become registration-enabling. As part of its strategy to maximize the IMA402 opportunity, the Company also plans 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.
Based on the initial promising activity of IMA401 in head and neck cancer and sqNSCLC, 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. The IMA402/IMA401 combination trial in sqNSCLC is expected to commence in 2026.

IMA401 MAGEA4/8 Bispecific – Maximizing the Potential of Bispecifics Combinations

In November 2025, Immatics presented clinical proof-of-concept data from the Phase 1a dose escalation trial evaluating IMA401 MAGEA4/8 bispecific as monotherapy or in combination with an immune checkpoint inhibitor in heavily pre-treated patients with solid tumors, including head and neck cancer and sqNSCLC.
The Company plans to present updated Phase 1a data at a major medical conference in the first half of 2026.
Consistent with Immatics’ focus on advancing its PRAME franchise, the Company is exploring IMA401 in combination with IMA402, starting with sqNSCLC.

Moderna Collaboration Expansion – TCER Multiplexing Strategy

In December 2025, Moderna decided to advance the first mRNA-based TCER product candidate from the existing collaboration with Immatics into clinical development.
This TCER, in-licensed by Moderna, is directed against an undisclosed Immatics proprietary target and is encoded in Moderna’s proprietary mRNA delivery system enabling in vivo production of the TCER molecule by the patient’s own body.
This collaboration aims to generate proof-of-principle data for the in vivo production of TCER molecules, potentially supporting a broader multiplex approach targeting multiple solid tumors.
This expansion of the collaboration triggered a milestone payment of $5 million to Immatics in January 2026. Immatics will conduct the Phase 1 trial, with all associated costs fully reimbursed by Moderna.
Corporate Developments

Chief Financial Officer Appointment: On October 1, 2025, Immatics announced the appointment of Venkat Ramanan, Ph.D., as Chief Financial Officer.
Chief People Officer Appointment: On October 27, 2025, Immatics announced the appointment of Amie Krause as Chief People Officer.
Full Year 2025 Financial Results

Cash Position: Cash and cash equivalents, as well as other financial assets, total $551.4 million1 (€469.3 million) as of December 31, 2025, compared to $710.3 million1 (€604.5 million) as of December 31, 2024. The decrease is mainly due to $234.9 million (€199.9 million) operational cash usage, principally as a result of ongoing research and development activities, as well as unrealized foreign exchange translational losses of $41.8 million1 (€35.6 million), which do not impact the expected cash reach, partially offset by the net proceeds of the public offering of $117.9 million1 (€100.3 million).

Revenue: Total revenue, consisting of revenue from collaboration agreements, was $56.8 million1 (€48.3 million) for the year ended December 31, 2025, compared to $183.1 million1 (€155.8 million) for the year ended December 31, 2024. The decrease is mainly the result of the one-time non-cash revenue associated with the acceleration of deferred revenue recognized due to the termination of the IMA401 and ACTallo collaborations by Bristol Myers Squibb during the year ended December 31, 2024.

Research and Development Expenses: R&D expenses were $216.0 million1 (€183.8 million) for the year ended December 31, 2025, compared to $174.0 million1 (€148.1 million) for the year ended December 31, 2024. The increase mainly resulted from costs associated with the advancement of the product candidates in clinical trials.

General and Administrative Expenses: G&A expenses were $60.2 million1 (€51.2 million) for the year ended December 31, 2025, compared to $54.5 million1 (€46.4 million) for the year ended December 31, 2024. The increase is driven by costs associated with early commercial activities supporting the planned market launch of anzu-cel (IMA203).

Net Profit and Loss: Net loss was $230.8 million1 (€196.4 million) for the year ended December 31, 2025, compared to a net profit of $17.9 million1 (€15.2 million) for the year ended December 31, 2024. The net loss mainly resulted from lower non-cash revenue recognized from the acceleration of deferred revenue recognized due to the termination of the collaboration agreements in the year ended December 31, 2024, and higher costs associated with the planned advancement of the Company’s PRAME franchise in clinical trials.

Full financial statements can be found in our Annual Report on Form 20-F filed with the Securities and Exchange Commission (SEC) on March 5, 2026, and published on the SEC website under www.sec.gov.

Upcoming Investor Conferences

Leerink Global Healthcare Conference, Miami, Florida, USA – March 8 – 11, 2026
Jefferies "Biotech by the Beach" Summit 2026, Miami, Florida, USA – March 10 – 11, 2026
To see the full list of events and presentations, visit: View Source

About PRAME
PRAME is a target expressed in more than 50 cancers. Immatics is the global leader in precision targeting of PRAME and has the broadest PRAME franchise with the most PRAME indications and modalities. The Immatics PRAME franchise currently includes three product candidates, two therapeutic modalities and two combination therapies that target PRAME: anzu-cel (anzutresgene autoleucel, IMA203) PRAME cell therapy, IMA203CD8 PRAME cell therapy (GEN2), IMA402 PRAME bispecific as monotherapy and in combination with an immune checkpoint inhibitor, as well as anzu-cel in combination with Moderna’s PRAME cell therapy enhancer.

(Press release, Immatics, MAR 5, 2026, View Source [SID1234663299])

On March 5, 2026 Evogene Ltd. (Nasdaq, TASE: EVGN), a pioneering company in computational chemistry specializing in the generative AI design of small molecules for the pharmaceutical and agricultural industries, reported its financial results for the fourth quarter and full year ended December 31, 2025.

Mr. Ofer Haviv, President & CEO of Evogene, stated: "During 2025, we executed a clear and decisive strategic shift. After a comprehensive review of our technology assets, target markets, and capital allocation priorities, we sharpened our focus to drive sustainable long-term value by concentrating on a single proprietary tech-engine – ChemPass AI- for small-molecule discovery and optimization. We streamlined our operations to focus on two high-impact markets: pharma and agriculture, while discontinuing non-core activities, divesting misaligned assets, resizing the organization, and aligning our business development efforts with this focused strategy. ChemPass AI’s competitive advantage combines two core strengths: generating truly novel molecules and simultaneously optimizing multiple critical parameters from the outset.

Throughout 2025, ChemPass AI was advanced through proprietary internal developments and strategic collaborations with Google Cloud. Our first collaboration delivered a foundation model trained on 38 billion structures, achieving 90% design precision, based on our calculation – approximately tripling our benchmarks for accuracy. A second collaboration, launched in February 2026, integrates AI agents via Google Cloud Vertex AI to automate workflows, reduce manual errors, and further strengthen candidate quality and commercial potential.

Evogene’s offering – our proprietary small-molecule product candidates – combines three unique powerful characteristics: novel molecules representing new and diverse chemical structures; optimized for simultaneous multi-parameters from the earliest design stages; and highly potent compounds refined through targeted experimental validation.

Our business model is built on an integrated, partnership-driven approach that supports both collaborations and the in-house advancement of proprietary candidates. Projects begin with joint strategic alignment and continue through rigorous experimental validation, with partners actively engaged at every stage and programs tailored to specific scientific and commercial objectives.

In pharma, since the second half of 2025, we have advanced multiple partnered drug discovery programs, with ChemPass AI candidates progressing into experimental testing by our partners; four collaborations have been publicly disclosed to date.

In agriculture, AgPlenus applies ChemPass AI to novel herbicide and fungicide development, supported by strategic collaborations with Bayer and Corteva and a differentiated internal pipeline, positioning us for continued growth."

Mr. Haviv continued: "As part of our focused strategy, we discontinued non-core activities, divested misaligned assets, and resized the organization. During 2025, Lavie Bio was acquired by ICL. In early 2026, Biomica licensed its lead oncology candidate, BMC128, to Lishan Pharmaceuticals. No additional activity is expected from these companies. At the same time, Evogene has retained select activities with meaningful value potential that are not at the core of our new strategy, including Casterra, and intends to continue supporting these activities until their full potential is realized.

Looking ahead, the advancement of proprietary small-molecule product candidates is at the heart of Evogene’s mission. Supported by ChemPass AI, our differentiated generative AI tech-engine, disciplined capital allocation across two high-potential markets, and strong strategic partnerships, we believe Evogene is well-positioned on a clearly defined and focused path toward sustainable long-term value creation."

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Financial Highlights:

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As part of the Company’s updated strategic plan, management implemented an organizational realignment and cost-reduction initiative. The effects of these measures are reflected in the significant decrease in operating expenses, net, which declined to approximately $13.8 million for the year ended 2025, compared to approximately $22.0 million in 2024. The impact is also evident in the fourth-quarter results, with total operating expenses, net, of approximately $3.2 million, compared to approximately $4.3 million in the corresponding period of 2024. The Company expects this reduced expense level to be sustained in future periods.

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In 2025, Lavie Bio, our subsidiary focused on agricultural biologicals, completed the sale of the majority of its operations to ICL Group Ltd. As a result of this transaction, Lavie Bio no longer maintains employees, and its operating expense level has decreased significantly. Lavie Bio anticipates distributing the majority of its remaining cash to its shareholders, including Evogene, during 2026.

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During 2025, as part of the Company’s updated strategic plan, we scaled down Biomica’s operations and research and development activities and reduced its personnel to a minimal level. In early 2026, Biomica entered into a license agreement with Lishan Pharmaceuticals for its lead oncology candidate, BMC128. Following this transaction, Biomica does not expect to conduct further material operational activities and anticipates distributing the majority of its remaining cash to its shareholders, including Evogene.

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With respect to AgPlenus, we integrated AgPlenus, our ag-chemical subsidiary, into our core operations, with the objective of maximizing the value of our ChemPass AI platform for the development of novel ag-chemical products. In alignment with the Company’s updated organizational structure, AgPlenus was resized and streamlined to reflect the revised operating model.

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During 2025, due to a significant decline in demand for castor seeds, Casterra Ag ceased its operations in Kenya, reduced its headcount and overall expense level, and is currently focusing its activities on the Brazilian market. As a result of these developments, Casterra recorded an impairment of approximately $2.2 million related to its seed inventory. This impairment is presented within Cost of Sales in the consolidated financial statements in a separate line item.

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In February 2026, we entered into a warrant inducement agreement with an existing investor providing for the immediate exercise in full of its August 2024 Series A and Series B warrants, resulting in gross proceeds to the Company of approximately $3.4 million, before deduction of placement agent fees and other offering expenses. In consideration for such exercise, the investor will receive, in a private placement, new unregistered Series A-1 and Series B-1 warrants to purchase up to an aggregate of 5,076,924 ordinary shares. The new warrants are exercisable immediately at an exercise price of $1.25 per ordinary share.

Financial reports:

Cash Position – As of December 31, 2025, Evogene held consolidated cash, cash equivalents, and short-term bank deposits of approximately $13.0 million. The consolidated cash usage during the fourth quarter of 2025 was approximately $3.0 million. Excluding Lavie Bio and Biomica, Evogene and its other subsidiaries used approximately $2.4 million in cash during the fourth quarter of 2025.

Revenues for 2025 totaled approximately $3.9 million, compared to approximately $5.6 million in the same period the previous year, reflecting a decrease of approximately $1.7 million. The decrease was primarily driven by lower revenue recognized from AgPlenus’ activity, which included one-time payment during the first quarter of 2024 and revenues recognized from the collaboration agreement with Corteva, that was completed during 2024. Revenues for the fourth quarter of 2025 were approximately $0.3 million; a decrease compared to approximately $1.5 million in the same period last year. The decrease was mainly due to reduced seed sales generated by Casterra during the fourth quarter of 2025.

Cost of Revenues for the year ending 2025 was approximately $4.1 million, compared to approximately $2.4 million in the previous year. The increase was primarily attributable to an inventory impairment of approximately $2.2 million recorded by Casterra during the fourth quarter of 2025 mainly due to its decision to cease its operations in Kenya as noted above. Cost of revenues for the fourth quarter of 2025 was $2.3 million, compared to $0.7 million in the fourth quarter of the previous year. The increase in quarterly cost of revenues was mainly driven by the same inventory impairment of Casterra as noted above.

R&D Expenses, net of non-refundable grants, for the year 2025 were approximately $8.0 million, a decrease of approximately $4.5 million compared to $12.5 million in the year 2024. The decrease was primarily due to reduced R&D expenses in Biomica, Casterra and AgPlenus. In the fourth quarter of 2025, R&D expenses were approximately $1.8 million, down from approximately $2.7 million in the same period of 2024. This decrease is mainly attributed to decreased expenses in Biomica.

Sales and Marketing Expenses for the year 2025 were approximately $1.5 million, a decrease of approximately $0.5 million compared to approximately $2.0 million in the same period last year. The decrease was mainly due to reductions in Evogene and Biomica personnel costs. Sales and marketing expenses for the fourth quarters of 2025 and 2024 were approximately $0.3 million and $0.4 million, respectively.

General and Administrative Expenses for the year 2025 decreased to approximately $4.3 million from approximately $7.0 million in the same period last year. This decrease is mainly attributable to expenses recorded during the year 2024 related to a provision for doubtful debt for one of Casterra’s seed suppliers as well as transaction costs associated with Evogene’s fundraising in August 2024. Additional decrease is attributable to a reduction in Biomica’s activities and personnel costs during 2025. General and administrative expenses for the fourth quarter of 2025 decreased to approximately $0.9 million compared to approximately $1.3 million in the same period of the previous year, primarily due to decreased expenses in Evogene and Biomica, as mentioned above.

Other Expenses, net of approximately $37 thousand were recorded in 2025 mainly due to the impairment of fixed assets associated with the reduction in Biomica’s activities, partially offset by income recognized in the first quarter of 2025 related to the accounting treatment of Evogene’s sub-lease agreement. The decision to cease Canonic’s operations in the first half of 2024 resulted in other expenses of approximately $0.5 million, primarily due to the impairment of fixed assets.

Operating Loss for 2025 was approximately $14.0 million, a significant decrease from approximately $18.8 million in the same period of the previous year, mainly due to decreased operating expenses, partially offset by the decreased revenues as mentioned above and the higher cost of revenues, mainly due to an inventory impairment of approximately $2.2 million recorded by Casterra, in the fourth quarter of 2025. The operating loss for the fourth quarter of 2025 was approximately $5.2 million, an increase from approximately $3.5 million in the same period of the previous year, primarily due to the decreased revenues and increased cost of revenues, mentioned above, partially offset by decreased operating expenses.

Financing Income, net for the year 2025 was approximately $0.6 million, compared to approximately $4.0 million in the previous year. The decrease in financing income, net was mainly associated with accounting treatment of pre-funded warrants and warrants issued in August 2024 fund raising. As a result, during the twelve months of 2025 the Company recorded financial income, net, related to pre-funded warrants and warrants of approximately $458 thousand as compared to a financial income of approximately $3.4 million in same period of 2024. Financing expenses, net, for the fourth quarter of 2025 were approximately $0.2 million, compared to financing income, net of approximately $4.5 million in the same period of the previous year. The decrease in financing income is mainly associated with accounting treatment of pre-funded warrants and warrants issued in the August 2024 fund raising as mentioned above.

Income from Discontinued Operations, net for the twelve months of 2025 was approximately $5.7 million, compared to a loss of approximately $3.2 million in the same period of 2024. For the fourth quarter of 2025, loss from discontinued operations, net was approximately $16 thousand, compared to a loss of approximately $1.0 million in the fourth quarter of the previous year. These amounts primarily reflect the financial results of Lavie Bio’s operations as well as expenses related to the development and maintenance of MicroBoost AI for Ag, which are presented as a single-line item in the consolidated statements of profit and loss. Following the sale of the majority of Lavie Bio’s assets as well as Evogene’s MicroBoost AI for Ag to ICL, the Company recognized a gain on sale of approximately $6.4 million which is also included in the income (loss) from discontinued operations, net, for the year of 2025. All prior period amounts have been reclassified to conform to this presentation.

Net loss for the twelve months of 2025 was approximately $7.8 million, compared to approximately $18.1 million in the same period last year. The $10.3 million decrease in net loss was primarily due to decreased operating expenses and an income derived from discontinued operations due to the asset sale to ICL, net, partially offset by reduced revenues, higher cost of revenues and a decreased financing income, net. The net loss for the fourth quarter of 2025 was approximately $5.4 million, compared to net loss of approximately $5 thousand in the same period last year. This increase in net loss was primarily due to decreased financial income, net, decreased revenues, and increased cost of revenues, partially offset by decreased operating expenses, as mentioned above.

(Press release, Evogene, MAR 5, 2026, View Source [SID1234663298])

On March 5, 2026 CytoDyn Inc. (OTCQB: CYDY) ("CytoDyn" or the "Company"), a clinical-stage oncology company advancing leronlimab, a first-in-class humanized monoclonal antibody targeting the CCR5 receptor with therapeutic potential across multiple indications, including triple-negative breast cancer (TNBC) and metastatic colorectal cancer (mCRC), reported that it has closed on a financing of $17.5 million in gross proceeds, with Paulson Investment Company acting as placement agent.

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The demand from both new and current investors highlights confidence in CytoDyn’s clinical progress and its versatile development strategy in immuno-oncology, exploring a number of potential roles for leronlimab – the Company’s first-in-class humanized monoclonal antibody that targets the CCR5 receptor.

"The successful completion of this financing in a challenging capital markets environment reflects meaningful investor support for our clinical strategy," said Robert E. Hoffman, CFO of CytoDyn. "The financing strengthens our balance sheet and is expected to fund current operations into 2027, supporting continued advancement of our clinical programs and strategic priorities. We appreciate the support of both new and existing investors, which underscores confidence in the continued development of leronlimab and its potential role in oncology, as we remain focused on disciplined execution and long-term value creation."

Net proceeds from the financing will primarily support the advancement of CytoDyn’s clinical development programs, including ongoing and planned trials, regulatory engagement, and data analysis. Additional funds may be allocated toward manufacturing readiness, regulatory and compliance infrastructure, and general working capital.

For more information on the Company’s recent fundraising activities, including key terms and conditions of some of the agreements, please see CytoDyn’s filings with the Securities and Exchange Commission, including its Current Report on Form 8-K filed on March 5, 2026.

(Press release, CytoDyn, MAR 5, 2026, View Source [SID1234663296])

On March 5, 2026 CorMedix Inc. (Nasdaq: CRMD), a biopharmaceutical company focused on developing and commercializing therapeutic products for life-threatening diseases and conditions, reported financial results for the fourth quarter and full-year ended December 31, 2025 and provided an update on its business.

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Recent Corporate Highlights:

CorMedix announces $128.6 million of net revenue for the fourth quarter of 2025, largely driven by continued utilization of DefenCath by its outpatient dialysis customers. DefenCath sales contributed $91.2 million of net revenue in the quarter.
For the full-year 2025, CorMedix achieved total revenue of $311.7 million and pro forma total revenue of $401.3 million.(1)
In the fourth quarter of 2025, the Company recognized Net Income of $14.0 million and adjusted EBITDA of $77.2 million.(2) Basic and Fully Diluted EPS were $0.18 and $0.16 per share, respectively.
CorMedix reiterates previously established guidance for 2026, including net revenue of between $300 and $320 million and adjusted EBITDA of between $100 and $125 million.
CorMedix announced in early February that its Board of Directors approved a share repurchase program, which authorizes the Company to repurchase up to $75 million of the Company’s outstanding common stock.
As highlighted during the Company’s recent Analyst Day, CorMedix expects clinical data from the Phase 3 ReSPECT study of REZZAYO (rezafungin for injection) in the prophylaxis of invasive fungal infections 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 the first half of 2027.
Cash and short-term investments, excluding restricted cash, at December 31, 2025 amounted to $148.5 million.
Joe Todisco, CorMedix Chairman and CEO, commented, "I am proud of the Company’s progress over the past year as we have accelerated the expansion of patient access for DefenCath, completed our acquisition and integration of Melinta, and saw progress in our two ongoing Phase 3 clinical programs for Rezzayo prophylaxis and DefenCath in TPN. With the announcement of our share repurchase program and multiple near-term milestones on the horizon, most notably the Rezzayo ReSPECT phase III data, CorMedix is focused on driving business growth and shareholder value over the year ahead."

Fourth Quarter and Full Year 2025 Financial Highlights

For the fourth quarter of 2025, CorMedix recorded $128.6 million in net revenue, comprised of $91.2 million in sales of DefenCath and $37.4 million in revenue associated with the Melinta portfolio, an increase from $31.2 million in net revenue in the comparable period of 2024. The fourth quarter of 2025 was the first full quarter of Melinta portfolio revenue after the closing of the acquisition in August 2025.

Total operating expenses in the fourth quarter of 2025 were $48.2 million, compared with $17.1 million in the fourth quarter of 2024, an increase of approximately 182%. The increase of $31.1 million over the prior period was driven primarily by the contribution of operating expenses from the Melinta acquisition for the full quarter. Fourth quarter 2025 operating expenses also included $4.1 million of non-recurring costs, including severance and other integration-related costs associated with the Melinta acquisition. Other drivers of increases year-over-year include stock-based compensation and investment in research and development programs associated with expanded indications for DefenCath, including the Phase III clinical study for prevention of CLABSI in TPN.

For the fourth quarter of 2025, the Company recorded $14.0 million in net income, or $0.16 per diluted share, compared with net income of $13.5 million, or $0.20 per diluted share, in the fourth quarter of 2024. Net income for the fourth quarter of 2025 included tax expense, primarily associated with the utilization of the Company’s deferred tax assets, of $42.4 million. These deferred tax assets were established in the third quarter of 2025 and are associated with the anticipated future use of CorMedix Net Operating Loss (NOL) carryforwards due to projected future sustained profitability of the Company. Also for the fourth quarter of 2025, CorMedix reported Adjusted EBITDA of $77.2 million, compared to adjusted EBITDA of $15.3 million in the fourth quarter of 2024.

For the year ended December 31, 2025, CorMedix recorded $311.7 million in total revenue, including $258.8 million in net sales of DefenCath and $52.9 million in net revenue from the legacy Melinta portfolio. Pro forma 2025 revenue, which reflects full-year revenue from the Melinta portfolio in addition to full-year net sales of DefenCath, was $401.3 million. The Company reported net income of $163.0 million, or $2.04 per diluted share, compared with a net loss of $17.9 million, or ($0.30) per share, in 2024. Net income was driven primarily by an increase in sales of DefenCath, and, to a lesser extent, net revenue from the acquisition of Melinta, partially offset by higher operating expenses.

Operating expenses during the year ended December 31, 2025 totaled $125.6 million compared with $62.6 million for 2024, an increase of $63.0 million, or 101%. The increase over the prior year was driven primarily by the acquisition of Melinta, including the contribution of operating expenses from Melinta’s business for the period from August 29, 2025 through the end of the year as well as transaction, integration and severance costs. Other drivers of the year-over-year increase include stock-based compensation and investment in research and development programs associated with expanded indications for DefenCath, including the Phase III clinical study for prevention of CLABSI in TPN.

The Company reported cash, cash equivalents and short-term investments of $148.5 million at December 31, 2025, excluding restricted cash.

(1) Pro Forma Total Revenue was prepared by combining the 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.

(2) Adjusted EBITDA is a non-GAAP financial measure and excludes non-cash items such as depreciation, amortization, stock-based compensation, interest and other income and expense, taxes and certain non-recurring items. See "Non-GAAP Financial Measures" on the following pages for additional information regarding the use of EBITDA and Adjusted EBITDA and a reconciliation to the most comparable GAAP measure.

Conference Call Information

The management team of CorMedix will host a conference call and webcast today, March 5, 2026, at 8:30AM Eastern Time, to discuss recent corporate developments and financial results. Call details and dial-in information are as follows:

March 5, 2026 @ 8:30am ET

Domestic: 1-844-676-2922
International: 1-412-634-6840
Webcast: Webcast Link

(Press release, CorMedix, MAR 5, 2026, View Source [SID1234663295])

On March 5, 2026 Caribou Biosciences, Inc. (Nasdaq: CRBU), a leading clinical-stage CRISPR genome-editing biopharmaceutical company, reported financial results for fourth quarter and full year 2025 and provided an overview of recent corporate highlights.

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"2025 was a year of strong execution for Caribou as we advance two potentially best-in-class allogeneic CAR-T cell therapy programs," said Rachel Haurwitz, PhD, Caribou’s president and CEO. "The vispa-cel ANTLER phase 1 data in second-line LBCL patients demonstrated efficacy and durability on par with autologous CAR-T therapy and solidified our confidence that this program is delivering on the promise of an off-the-shelf CAR-T cell therapy with speed, scalability, and access. We continue to engage with the FDA on the pivotal trial design and look forward to reporting longer follow up on the phase 1 data later this year. In addition, we initiated dose expansion of the CB-011 CaMMouflage phase 1 clinical trial for patients with multiple myeloma and look forward to sharing initial dose expansion data and longer follow-up on dose escalation data later this year."

Clinical highlights
Vispacabtagene regedleucel (vispa-cel; formerly CB-010), a clinical-stage allogeneic anti-CD19 CAR-T cell therapy for patients with relapsed or refractory B cell non-Hodgkin lymphoma
•On February 5, 2026, Caribou presented a poster at the 2026 Tandem Meetings that included the clinical data disclosed in November 2025 as well as new supportive translational data that demonstrate vispa-cel drives outcomes that are on par with autologous CAR-T cell therapies. These data highlight vispa-cel’s potential as the best-in-class allogeneic CAR-T cell therapy for second-line (2L) large B cell lymphoma (LBCL).
•Caribou is in ongoing engagement with the FDA regarding the design of the pivotal trial for vispa-cel in 2L LBCL.
•Longer follow up from the ANTLER phase 1 clinical trial data is expected in 2026.

CB-011, a clinical-stage allogeneic anti-BCMA CAR-T cell therapy for patients with relapsed or refractory multiple myeloma (r/r MM)
•On February 7, 2026, Caribou delivered an oral presentation at the 2026 Tandem Meetings that included the clinical data disclosed in November 2025 as well as new supportive translational data that correlate CAR-T cell expansion with deep, durable responses and support the regimen selected for dose expansion (450×106 CAR-T cells following a lymphodepletion regimen of 500 mg/m2 cyclophosphamide and 30 mg/m2 fludarabine daily for three days). These data highlight CB-011’s potential as the best-in-class allogeneic CAR-T cell therapy for patients with r/r MM.
•Caribou is enrolling BCMA naïve and prior BCMA exposed r/r MM patients in the dose expansion portion of the CaMMouflage trial and expects to report initial dose expansion data as well as longer follow up on dose escalation data in 2026.

Upcoming events
•Leerink 2026 Global Healthcare Conference, Miami, FL
March 10, 2026, fireside chat at 8:00 am ET
View Source

Fourth quarter and full year 2025 financial results
Licensing and collaboration revenue: Revenue from Caribou’s licensing and collaboration agreements was $3.9 million for the three months ended December 31, 2025 and $11.2 million for full year 2025, compared to $2.1 million and $10.0 million, respectively, for the same periods in 2024. The increase for full year 2025 was primarily driven by a net increase in revenues related to prior licenses of certain of Caribou’s intellectual property to third parties.
R&D expenses: Research and development expenses were $23.8 million for the three months ended December 31, 2025 and $109.4 million for full year 2025, compared to $30.5 million, and $130.2 million respectively, for the same periods in 2024. The decrease for full year 2025 was primarily due to lower R&D and personnel-related expenses related to the reduction in workforce and strategic pipeline prioritization, external contract manufacturing and contract research organization activities and timing of activities for clinical trials, expenses related to licenses, sublicensing revenue, and milestones, and other facilities and allocated expenses.

G&A expenses: General and administrative expenses were $8.6 million for the three months ended December 31, 2025 and $37.9 million for full year 2025, compared to $10.5 million and $46.5 million, respectively, for the same periods in 2024. The decrease for full year 2025 was primarily due to lower legal expenses and personnel-related expenses related to the reduction in workforce and strategic pipeline prioritization.
Non-recurring, non-cash impairment charges: Non-recurring, non-cash impairment charges were $21.3 million for the year ended December 31, 2025, and include charges related to the previously announced strategic pipeline prioritization and an impairment of Caribou’s stock investment in a private company. There were no non-recurring, non-cash impairment charges for full year 2024.
GAAP net loss and net loss per share (basic and diluted): Caribou reported GAAP net loss of $26.5 million, or $0.28 per share, for the three months ended December 31, 2025 and $148.1 million, or $1.59 per share, for full year 2025, compared to a net loss of $35.5 million, or $0.39 per share, and $149.1 million, or $1.65 per share, respectively, for the same periods in 2024.
Non-GAAP net loss and net loss per share (basic and diluted): Caribou reported non-GAAP net loss of $126.8 million, or $1.36 per share, for full year 2025, compared to non-GAAP net loss of $149.1 million, or $1.65 per share, for full year 2024. Non-GAAP net loss for full year 2025 excludes $21.3 million of non-cash impairment charges incurred for second quarter 2025.

Cash, cash equivalents, and marketable securities: Caribou reported $142.8 million in cash, cash equivalents, and marketable securities as of December 31, 2025, compared to $249.4 million as of December 31, 2024. Caribou expects its cash, cash equivalents, and marketable securities will be sufficient to fund its current operating plan, including dose expansion for CB-011 and certain start-up activities for its planned vispa-cel pivotal trial, into 2H 2027. Caribou is exploring multiple options to fully fund its planned vispa-cel pivotal trial.
Note regarding use of non-GAAP financial measures
In this press release, Caribou has presented certain financial information that has not been prepared in accordance with U.S. generally accepted accounting principles ("GAAP"). These non-GAAP financial measures are non-GAAP net loss and non-GAAP net loss per share, which are defined as net loss and net loss per share, respectively, excluding non-cash impairment charges. Caribou believes that these non-GAAP financial measures, when considered together with the GAAP figures, can enhance an overall understanding of Caribou’s operational performance from period-to-period by excluding items that are not indicative of Caribou’s core business operations. The non-GAAP financial measures are included with the intent of providing investors with a more complete understanding of Caribou’s operating results and underlying business trends. In addition, these non-GAAP financial measures are among the indicators Caribou’s management uses for planning purposes and to measure Caribou’s performance. These non-GAAP financial measures should be considered in addition to, and not as a substitute for, or superior to, financial measures calculated in accordance with GAAP. The non-GAAP financial measures used by Caribou may be calculated differently from, and therefore may not be comparable to, non-GAAP financial measures used by other companies. Please refer to the below reconciliation of these non-GAAP financial measures to the comparable GAAP financial measures.

About vispacabtagene regedleucel
Vispacabtagene regedleucel (vispa-cel; formerly known as CB-010) is an allogeneic anti-CD19 CAR-T cell therapy evaluated in patients with relapsed or refractory B cell non-Hodgkin lymphoma (r/r B-NHL). To Caribou’s knowledge, vispa-cel is the first allogeneic CAR-T cell therapy in the clinic with a PD-1 knockout, a genome-editing strategy designed to enhance CAR-T cell activity by limiting premature CAR-T cell exhaustion. The FDA granted vispa-cel Regenerative Medicine Advanced Therapy (RMAT), Fast Track, and Orphan Drug designations for B-NHL.

About the ANTLER phase 1 clinical trial
The ANTLER clinical trial is a multicenter, open-label phase 1 trial that evaluated vispa-cel in adult patients with r/r B-NHL. Eighty-four patients were treated in the ANTLER clinical trial as of September 2, 2025. Using a 3+3 enrollment strategy, safety and efficacy were assessed in 16 patients in dose escalation evaluating 40×106, 80×106, and 120×106 CAR-T cell dose levels with a lymphodepletion (LD) regimen of cyclophosphamide at 60 mg/kg/day for 2 days followed by fludarabine at 25 mg/m2/day for 5 days. Forty-one second-line large B cell lymphoma (2L LBCL) patients were enrolled in the dose expansion portion, and 80×106 CAR-T cells was selected as the recommended phase 2 dose (RP2D). An additional 22 2L LBCL patients were enrolled in the confirmatory cohort, which prospectively evaluated Caribou’s partial HLA matching strategy. Five patients were enrolled in a cohort of third-line or later LBCL patients with prior exposure to CD19-targeted therapy. Additional information on the ANTLER trial (NCT04637763) can be found at www.clinicaltrials.gov.

About CB-011
CB-011 is an allogeneic anti-BCMA CAR-T cell therapy being evaluated in patients with relapsed or refractory multiple myeloma (r/r MM). To Caribou’s knowledge, CB-011 is the first allogeneic CAR-T cell therapy in the clinic that is engineered to enable activity through an immune cloaking strategy with a B2M knockout and insertion of a B2M–HLA-E fusion protein to blunt immune-mediated rejection. CB-011 has been granted Fast Track and Orphan Drug designations by the FDA.

About the CaMMouflage phase 1 clinical trial
The CaMMouflage clinical trial is a multicenter, open-label phase 1 trial evaluating CB-011 in adults with r/r MM who have been treated with three or more prior lines of therapy. Using a 3+3 dose escalation design, safety and efficacy of CB-011 were evaluated in 48 patients at multiple dose levels and two different lymphodepletion (LD) regimens. Thirteen patients were treated with a single dose of CB-011 (50×106 [N=3], 150×106 [N=7], and 450×106 [N=3] CAR-T cells) with an LD regimen of 300 mg/m2 cyclophosphamide and 30 mg/m2 fludarabine daily for 3 days, and 35 patients were treated with a single dose of CB-011 (150×106 [N=6], 300×106 [N=13], 450×106 [N=13], and 800×106 [N=3] CAR-T cells) with an LD regimen of 500 mg/m2 cyclophosphamide and 30 mg/m2 fludarabine daily for 3 days. The dose expansion portion of the trial will evaluate safety and efficacy of CB-011 at 450×106 CAR-T cells with the selected LD of 500 mg/m2 cyclophosphamide and 30 mg/m2 fludarabine daily for three days. Additional information on the CaMMouflage trial (NCT05722418) can be found at www.clinicaltrials.gov.

(Press release, Caribou Biosciences, MAR 5, 2026, View Source [SID1234663294])