On February 13, 2026 vTv Therapeutics Inc. (Nasdaq: VTVT), a late-stage biopharmaceutical company focused on the development of cadisegliatin, a novel, potential first-in-class oral adjunctive therapy to insulin being investigated for the treatment of type 1 diabetes (T1D), reported that management will participate in the following upcoming investor conferences:

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Oppenheimer 36th Annual Healthcare Life Sciences Conference
Date: Thursday, February 26, 2026
Time: 11:20 AM ET
Format: Presentation Only
Location: Virtual
Webcast Link

TD Cowen 46th Annual Health Care Conference
Date: Tuesday, March 3, 2026
Time: 9:50 AM ET
Format: Presentation and 1×1 Meetings
Location: Boston, MA

(Press release, vTv Therapeutics, FEB 13, 2026, View Source [SID1234662673])

On February 13, 2026 Moderna, Inc. (NASDAQ:MRNA) reported financial results and provided business updates for the fourth quarter of 2025.

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"In 2025, we sharpened our commercial execution, launched our third product and brought online three international manufacturing sites, while advancing our mRNA pipeline. At the same time, we lowered our annual operating expenses by approximately $2.2 billion, significantly surpassing our cost-reduction targets," said Stéphane Bancel, Chief Executive Officer of Moderna. "We entered the new year with strong momentum despite the continued challenging environment in the U.S., poised to deliver up to 10 percent revenue growth through mNEXSPIKE expansion and our international strategic partnerships. We look forward to delivering multiple potential product approvals and late-stage clinical readouts, while driving continued innovation across our mRNA platform."

Commercial Updates

Moderna is entering the year with three approved products, Spikevax, mNEXSPIKE and mRESVIA, with seasonal vaccines expected to deliver up to 10% revenue growth in 2026. In line with its strategy to drive growth through geographic expansion and new product launches, the Company recently announced long-term agreements with Mexico and Taiwan for respiratory vaccines, received regulatory approvals in Canada and Australia for mNEXSPIKE, and the strain-updated Spikevax vaccine was authorized in the UK for use in the spring vaccination campaign. The Company also announced a strategic collaboration with Recordati to globally commercialize Moderna’s propionic acidemia candidate.

Fourth Quarter 2025 Financial Results

Revenue: Total revenue for the fourth quarter of 2025 was $678 million, on the higher end of the Company’s prior expectations, and was driven primarily by COVID vaccine sales. Product sales were $264 million in the U.S. and $381 million in international markets. Fourth quarter revenue decreased 30% compared to the same period in 2024, primarily reflecting lower COVID vaccine sales volume compared to the prior-year period.

Cost of Sales: Cost of sales for the fourth quarter of 2025 was $452 million, including third-party royalties of $34 million and inventory write-downs of $144 million. Cost of sales decreased 39% compared to the same period in 2024, primarily reflecting lower contract manufacturing wind-down costs and inventory write-downs.

Research and Development Expenses: Research and development expenses for the fourth quarter of 2025 were $775 million, a 31% decrease compared to the same period in 2024. The decrease was driven primarily by lower clinical development and manufacturing costs, reflecting the wind-down of large Phase 3 respiratory programs, continued portfolio prioritization and cost discipline across the organization.

Selling, General and Administrative Expenses: Selling, general and administrative expenses for the fourth quarter of 2025 were $308 million, a 12% decrease compared to the same period in 2024. The decline was primarily driven by reductions in consulting and external services across multiple functions, reflecting continued discipline across the organization.

Income Taxes: Income tax provisions for both periods were not material, as the Company continues to maintain a global valuation allowance against most of its deferred tax assets.

Net Loss: Net loss was $(826) million for the fourth quarter of 2025, compared to net loss of $(1.1) billion for the fourth quarter of 2024.

Loss Per Share: Loss per share was $(2.11) for the fourth quarter of 2025, compared to loss per share of $(2.91) for the fourth quarter of 2024.

Full Year 2025 Financial Results

Revenue: Total revenue for the full year 2025 was $1.9 billion, a 40% decrease compared to 2024, with the majority generated from COVID vaccine sales, along with $126 million of other revenue. U.S. revenue totaled $1.2 billion, while revenue from international markets was $745 million. The year-over-year decrease primarily reflected lower COVID vaccine sales volume across all regions. During 2025, the Company also began recognizing stand-ready manufacturing revenue related to its long-term strategic partnerships, which is reported in other revenue.

Cost of Sales: Cost of sales for the full year 2025 was $868 million, including third-party royalties of $88 million and inventory write-downs of $291 million. Cost of sales decreased 41% compared to 2024, driven primarily by manufacturing productivity and operational efficiencies, lower inventory write-downs, lower contract manufacturing wind-down costs, and lower sales volume.

Research and Development Expenses: Research and development expenses for the full year 2025 were $3.1 billion, a 31% decrease compared to 2024. The decrease was driven primarily by lower clinical development and manufacturing costs, reflecting the wind-down of large Phase 3 respiratory programs, continued portfolio prioritization and cost discipline across the organization. These decreases were partially offset by increased investment in the Company’s norovirus vaccine and oncology programs. In addition, 2024 included costs related to the purchase of two priority review vouchers, which did not recur in 2025.

Selling, General and Administrative Expenses: Selling, general and administrative expenses for the full year 2025 were $1.0 billion, a 13% decrease compared to 2024. The decrease was driven primarily by lower consulting and external services, along with reduced spending across multiple functions and operating areas, while the Company continued to invest in supporting its commercial operations and broader business activities.

Income Taxes: Income tax provisions for both periods were not material, as the Company continues to maintain a global valuation allowance against most of its deferred tax assets.

Net Loss: Net loss for the full year 2025 was $2.8 billion, compared to $3.6 billion for the full year 2024.

Loss Per Share: Loss per share for the full year 2025 was $(7.26), compared to $(9.28) for the full year 2024.

Cash Position: Cash, cash equivalents and investments as of December 31, 2025, were $8.1 billion, compared to compared to $9.5 billion as of December 31, 2024. The year-end balance included a $600 million initial draw on the Company’s $1.5 billion credit facility, with the year-over-year decrease primarily driven by operating losses associated with continued investment in research and development and advancement of the Company’s pipeline.

2026 Financial Framework

Revenue: The Company is targeting up to 10% growth from 2025 revenue and expects 2026 revenue split to be approximately 50% U.S. and approximately 50% international.

Cost of Sales: Cost of sales for 2026 is expected to be approximately $0.9 billion.

Research and Development Expenses: Research and development expenses for 2026 are anticipated to be approximately $3.0 billion.

Selling, General and Administrative Expenses: Selling, general and administrative expenses for 2026 are projected to be approximately $1.0 billion.

Income Taxes: The Company expects its full-year tax expense to be negligible.

Capital Expenditures: Capital expenditures for 2026 are expected to be $0.2 to $0.3 billion.

Cash and Investments: Year-end cash and investments for 2026 are projected to be $5.5 to $6.0 billion. Excludes any additional draw down from the Company’s credit facility.

Recent Progress and Upcoming Late-Stage Pipeline Milestones

Infectious disease vaccines:

Seasonal flu + COVID vaccine: Currently, the Company’s mRNA-1083 regulatory filing is under review in Europe and Canada. Moderna is awaiting further guidance from U.S. FDA on refiling the submission for its flu/COVID combination vaccine.

Seasonal flu vaccine: The Company’s mRNA-1010 regulatory filings are under review in Europe, Canada and Australia and potential approvals are expected to begin in 2026. Moderna received a Refusal-to-File letter from the U.S. FDA and has requested a Type A meeting to understand the path forward.

Norovirus vaccine: Moderna’s ongoing Phase 3 safety and efficacy study of mRNA-1403 is fully enrolled in a second Northern Hemisphere season (2025-2026) with a data readout expected in 2026, subject to case accruals.

Oncology therapeutics:

Intismeran autogene: The Company is advancing mRNA-4157 in collaboration with Merck, with eight total Phase 2 and Phase 3 clinical trials underway across multiple tumor types including melanoma, non-small cell lung cancer (NSCLC), bladder cancer and renal cell carcinoma. The Phase 3 adjuvant melanoma, the Phase 2 adjuvant renal cell carcinoma, and most recently, the Phase 2 adjuvant muscle invasive bladder cancer trials are fully enrolled. Moderna and Merck recently announced positive five-year Phase 2b adjuvant melanoma data, which showed intismeran autogene in combination with KEYTRUDA reduced the risk of recurrence or death by 49% compared to KEYTRUDA alone. Moderna expects Phase 3 adjuvant melanoma data potentially in 2026.

mRNA-4359: Moderna’s Phase 1/2 study of mRNA-4359, an investigational wholly-owned cancer antigen therapy, is ongoing. The Phase 2 portion of the study includes cohorts in first-line metastatic melanoma, second-line+ metastatic melanoma and first-line metastatic NSCLC, and the Company expects a potential Phase 2 data readout in 2026.

Rare disease therapeutics:

Propionic acidemia (PA) therapeutic: The Company’s PA candidate, mRNA-3927, is in a registrational study and target enrollment has been reached. Moderna expects a potential data readout in 2026.

Methylmalonic acidemia (MMA) therapeutic: Moderna’s mRNA-3705 has been selected by the FDA for the Support for Clinical Trials Advancing Rare Disease Therapeutics (START) pilot program, with a registrational study expected to begin in 2026.

Moderna Corporate Updates

Hosted Analyst Day event highlighting pipeline progress and business strategy updates on November 20, 2025.

Published Moderna CEO Stéphane Bancel’s annual letter to shareholders on January 5, 2026.

Provided business and pipeline updates at the 44th Annual J.P. Morgan Healthcare Conference on January 12, 2026.

Appointed David Berman, M.D., Ph.D. to Chief Development Officer of Moderna, effective March 2, 2026.

Scheduled the Moderna Annual Meeting of Shareholders to be held on Wednesday, May 6, 2026, at 8:00 a.m. ET.

Company Accolades

Moderna was recognized by TIME as one of America’s Most Iconic Companies.

Key 2026 Investor and Analyst Event Dates

Analyst Day: November 12

Investor Call and Webcast Information

Moderna will host a live conference call and webcast at 8:00 a.m. ET on February 13, 2026. To access the live conference call via telephone, please register at the link below. Once registered, dial-in numbers and a unique pin number will be provided. A live webcast of the call will also be available under "Events and Presentations" in the Investors section of the Moderna website.

Telephone: View Source

Webcast: View Source

The archived webcast will be available on Moderna’s website approximately two hours after the conference call and will be available for one year following the call.

(Press release, Moderna Therapeutics, FEB 13, 2026, View Source [SID1234662672])

On February 13, 2026 HCW Biologics Inc. ("HCW Biologics") (NASDAQ: HCWB), a U.S.-based clinical-stage biopharmaceutical company focused on discovering and developing innovative immunotherapies to extend health span by targeting the link between chronic inflammation and disease, and WY Biotech Co., Ltd. ("WY Biotech"), a China-based company specializing in the early-stage development of recombinant protein drugs and gene/cell therapies, today jointly announced the commencement of an exclusive worldwide license agreement covering the development and commercialization rights for certain in vivo applications for one of HCW Biologics’ proprietary molecules, HCW11-006. For additional consideration, the deal also includes an option to license the exclusive Greater China rights to clinical development and commercialization for in vivo applications of HCW9302, HCW Biologics’ clinical-stage molecule currently being evaluated for the treatment of an autoimmune disorder.

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For this venture, WY Biotech and HCW Biologics formed a new operating entity, Beijing Trimmune Biotech Co., Ltd. ("Trimmune"), which is the licensee responsible for the development and commercialization of the licensed molecules. Trimmune is backed by the CITIC Medical Fund ("CITIC"), a multi-billion-dollar investment fund focused on innovative companies primarily targeting pharmaceuticals, biotechnology, medical devices, and diagnostics, and TigerYeah Capital Fund of TigerMed ("TigerMed"), a global leading Contract Research Organization. Trimmune is led by a team with an impressive track record for success in the development and commercialization of innovative drugs that treat diseases with large, unmet medical needs for the Chinese market.

Upon completing the financing agreements with CITIC and TigerMed, Roger Lu, Chairman of Trimmune, stated, "With a strong financial foundation now in place, including receipt of initial funding from TigerMed, Trimmune is now able to begin funding the upfront licensing fee and formally commence our partnership with HCW Biologics. The scientists at HCW Biologics are partners who will make critical contributions to the development of HCW11-006 as well as share in the success of this program through our profit-sharing arrangement for major transactions and its significant equity stake in this joint enterprise. With the expertise of HCW Biologics and TigerMed, and with the strong support of Chinese venture partners, we have the expertise and resource commitments to build a strong clinical development program to treat cancer-related diseases in both the Chinese-NMPA and the US-FDA systems."

Mr. Lu continued, "Based on strong data seen in results of preclinical in-vitro and in-vivo studies, Trimmune expects to initiate a Phase 1 clinical trial in China to evaluate HCW11-006 in the treatment of solid tumors in the first half of 2027. Our strategy is to demonstrate clinical data that we believe will provide significant medical benefits to a large patient population."

Mr. Lu added, "The value of HCW11-006 development, together with Trimmune’s development capability, is well recognized by the venture capital circle, the pharmaceutical industry, and the top oncologists in China." He further said, "Closely collaborating with HCW Biologics, Trimmune believes it will be able to demonstrate HCW11-006’s clinical benefits that will capture the global pharmaceutical industry’s attention, opening the door for further business development opportunities."

Today, Trimmune is initiating payment of half of the $3.5 million upfront cash license fee to HCW Biologics ($1,750,000), with the remainder to be paid on or before March 6, 2026. The $3.5 million upfront license fee, combined with HCW Biologics’ minority co-founder equity position in Trimmune, also currently valued at approximately $3.5 million, constitute consideration for the HCW11-006 license. In addition to the upfront license fee, HCW Biologics is eligible to receive significant development milestone payments and double-digit royalties on future product sales, as well as a portion of the proceeds from future transaction(s) involving the licensed molecule, if and when such transaction(s) occur.

Additionally, HCW Biologics has a payment-free, milestone-free, and royalty-free option to recapture all rights to the development and commercialization of HCW11-006 for in vivo applications in the United States, Canada, Central America, and South America (Opt-in Territory) after the conclusion of the Phase 1 clinical trial in China. If HCW Biologics exercises the option, HCW Biologics and Trimmune will be co-development partners. The parties agreed to build unified clinical programs, and to work together in the business development operations when the HCW11-006 co-development project generates key clinical data, to actively explore business development opportunities with multi-national corporations.

Each party will be financially responsible for all costs associated with research and development, manufacturing, clinical development, regulatory approval, and commercialization for the licensed molecule in its territory. Therefore, expenses to complete the first Phase 1 clinical trial in China will be paid by Trimmune. This arrangement allows HCW Biologics to have direct access to the Phase 1 results without financial responsibility for the cost.

Dr. Hing C. Wong, Ph.D., Chief Executive Officer of HCW Biologics, said, "We are excited that WY Biotech and HCW Biologics have successfully established an entity to laser focus on the development and commercialization of HCW11-006. We believe we have provided Trimmune with a running start in its clinical development efforts. Along with our collaborators, who are leaders in the immunotherapeutic field, HCW Biologics has already demonstrated that HCW11-006 is a highly promising drug candidate as an injectable immunotherapeutic for cancer and infectious diseases."

Dr. Wong continued, "We are also pleased to be working with Trimmune’s seasoned management team. We are satisfied with Trimmune’s capabilities in financing, pre-clinical and clinical development, and business development. HCW11-006 is the first high-potential molecule created with our promising TRBC platform. We will be working closely with Trimmune to continue to develop HCW11-006 with the goal of creating treatments for indications that currently have none available, to benefit a large population of patients."

(Press release, HCW Biologics, FEB 13, 2026, View Source [SID1234662671])

On February 13, 2026 Exact Sciences Corp. (Nasdaq: EXAS), a leading provider of cancer screening and diagnostic tests, reported that the Company generated revenue of $878 million for the fourth quarter of 2025 and $3.25 billion for the full year of 2025, both ended December 31, 2025.

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"In 2025 the Exact Sciences team delivered on our mission by screening more people than ever before, helping guide more personalized treatment decisions, and successfully launching three new tests," said Kevin Conroy, Chairman and CEO of Exact Sciences. "These defining milestones show what the Exact Sciences team can achieve through a relentless focus on our mission and a dedication to improving the lives of patients. As we look to the future, momentum continues to build. Our core products are driving strong growth, our portfolio is expanding, and we are uniquely positioned to drive lasting change in the way cancer is found and treated globally."

Fourth quarter 2025 financial results

For the three-month period ended December 31, 2025, as compared to the same period of 2024 (where applicable):

Total revenue was $878 million, an increase of 23% on a reported and core revenue basis
Screening revenue was $695 million, an increase of 26%
Precision Oncology revenue was $183 million, an increase of 14%, or 16% on a core revenue basis
Gross margin was 70% and adjusted gross margin was 73%
Net loss was $86 million, or $0.45 per share, compared to a net loss of $49.8 million, or $0.27 per share
Adjusted EBITDA was $63 million, and adjusted EBITDA margin was 7%. As previously announced, adjusted EBITDA was impacted by an R&D expense of $75.0 million related to our collaboration and license agreement with Freenome Holdings, Inc. in the fourth quarter
Operating cash flow was $152 million and free cash flow was $120 million in the fourth quarter, an improvement of $105 million and $110 million, respectively
Cash, cash equivalents, and marketable securities were $965 million at the end of the quarter
Screening primarily includes laboratory service revenue from Cologuard tests and PreventionGenetics. Precision Oncology includes laboratory service revenue from global Oncotype DX and therapy selection tests.

Platform and pipeline advancements

In the fourth quarter, Exact Sciences announced the first clinical study results from its Oncodetect molecular residual disease test in breast cancer. Findings from the NSABP B-59 substudy, conducted in collaboration with the NSABP Foundation and the German Breast Group, demonstrated that the Oncodetect test strongly predicts distant recurrence following surgery in patients with early triple-negative breast cancer, one of the most aggressive and difficult-to-treat breast cancer subtypes.

Exact Sciences also announced pivotal clinical validation results from the ALTUS study in the fourth quarter. The prospective, head-to-head trial demonstrated that the company’s Oncoguard Liver blood test delivers superior early-stage and overall sensitivity for hepatocellular carcinoma — the most common form of liver cancer — compared to the current standard of care.

Additionally, in the fourth quarter, the Company announced the expiration of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 for its previously announced license agreement with Freenome. Under the agreement, the Company acquired exclusive rights in the United States to Freenome’s blood-based colorectal cancer screening tests. The exclusive license expands the Company’s leadership in cancer screening by adding blood-based CRC screening options to its portfolio. Exclusivity remains subject to Freenome’s test receiving first-line FDA approval.

Pending merger

As previously announced, on November 19, 2025, the Company entered into an Agreement and Plan of Merger (the "Merger Agreement") with Abbott Laboratories ("Abbott") and Badger Merger Sub I, Inc., a direct, wholly owned subsidiary of Abbott ("Merger Sub"), providing for the merger of Merger Sub with and into Exact (the "Merger"). On February 20, 2026, we will hold a special meeting of stockholders to adopt the Merger Agreement. Upon the terms and subject to the conditions set forth in the Merger Agreement, at the effective time of the Merger, the separate existence of Merger Sub will cease, and we will continue as the surviving corporation in the Merger as a wholly-owned subsidiary of Abbott.

The consummation of the Merger remains subject to the satisfaction or waiver of customary closing conditions. The two parties are continuing to engage with regulators reviewing the proposed transaction and are working toward closing in the second quarter of 2026, subject to obtaining required regulatory approvals and satisfaction or waiver of other customary closing conditions.

Fourth quarter conference call

As a result of the pending Merger with Abbott, the Company will not be holding a fourth quarter conference call.

(Press release, Exact Sciences, FEB 13, 2026, View Source [SID1234662670])

On February 13, 2026 Citius Pharmaceuticals, Inc. ("Citius Pharma" or the "Company") (Nasdaq: CTXR), a biopharmaceutical company dedicated to the development and commercialization of first-in-class critical care products reported business and financial results for the fiscal first quarter ended December 31, 2025, and provided a business update, including progress at its majority-owned subsidiary, Citius Oncology, Inc. (Nasdaq: CTOR)..

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"I am thrilled to report that we have successfully transitioned to a revenue generating company following Citius Oncology’s December 2025 launch of LYMPHIR. We recorded $3.9 million in revenue during the quarter, reflecting the initial sales at Citius Oncology’s nationwide network of distributors. This milestone is the result of years of focused execution designed to translate innovation into tangible value for the cutaneous T-cell community and Citius stakeholders alike. I congratulate the entire Citius team on an outstanding effort to bring LYMPHIR to market," said Leonard Mazur, Chairman and Chief Executive Officer of Citius Oncology and Citius Pharma.

"While we are still in the early stages of the launch, we expect momentum to build as we continue to stand up the full commercial organization and more fully deploy our technology-driven platform to expand patient access and drive market penetration. Looking ahead, we see multiple avenues for growth, including encouraging early signals from investigator-initiated studies, opportunities to expand access in international markets, and the potential to build a durable oncology franchise. Most importantly, LYMPHIR now offers patients living with cutaneous T-cell lymphoma a meaningful new treatment option and a more hopeful future," added Mazur.

"We remain committed to financial stewardship to sustain this momentum, and focused execution to advance our late-stage pipeline, which includes Mino-Lok and Halo-Lido. Our goal remains to serve our community with first-in-class critical care products, and in so doing maximize long-term shareholder value," concluded Mazur.

Business Highlights and Subsequent Developments

● Commercial inflection achieved through majority-owned subsidiary: Citius Oncology successfully launched LYMPHIR (denileukin diftitox-cxdl) in the U.S. in December 2025 for adult patients with relapsed or refractory Stage I–III cutaneous T-cell lymphoma (CTCL) following at least one prior systemic therapy;

● Early physician adoption underway: Initial specialty distributor sales were completed nationwide, enabling product availability across U.S. treatment centers. Patients have begun receiving LYMPHIR at leading cancer centers;

● Commercial execution supported by technology: Citius Oncology deployed an AI-enabled commercial platform to support targeted physician engagement and efficient penetration of a highly concentrated prescriber base in this rare oncology market;

● International patient access advancing: Agreements have been negotiated with regional partners to enable patient access to LYMPHIR utilizing Named Patient Programs (NPPs) where permitted in territories throughout European and the Middle East;

● Continued support of promising upside opportunities for LYMPHIR: Preliminary topline data from two investigator-initiated Phase I combination studies evaluating the potential to expand clinical utility and future label expansion opportunities. include:

o use in combination with pembrolizumab in patients with recurrent solid tumors;

o incorporation as part of lymphodepletion regimens prior to CAR-T therapy;

● Late-stage pipeline progress maintained: Citius Pharma continues to advance Mino-Lok, an antibiotic lock solution to salvage catheters when treating catheter-related bloodstream infections, and Halo-Lido (CITI-002), a topical prescription formulation for hemorrhoids. The Company remains engaged with the FDA regarding both programs.

First Quarter 2026 Financial Highlights

● Cash and cash equivalents totaled $7.7 million as of December 31, 2025;

● Generated net proceeds of approximately $20.9 million from equity financings during the quarter, including capital raised at both Citius Pharma and Citius Oncology;

● Consolidated revenue was $3.9 million, reflecting initial U.S. sales of LYMPHIR at Citius Oncology;

● Research and development expenses were $1.6 million, compared to $2.1 million in the prior-year period, reflecting reduced clinical development activity;

● General and administrative expenses totaled $5.7 million, compared to $5.4 million in the prior-year period;

● Stock-based compensation expense totaled $4.3 million, compared to $2.5 million in the prior-year period; and,

● Net loss applicable to common stockholders was $8.2 million, or $(0.41) per share, compared to a net loss of $9.8 million, or $(1.30) per share, in the prior-year period.

(Press release, Citius Pharmaceuticals, FEB 13, 2026, View Source [SID1234662669])