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])

On February 13, 2026 Amgen (NASDAQ:AMGN) reported that it will present at Citi’s 2026 Virtual Oncology Leadership Summit at 12:15 p.m. PT on Wednesday, Feb. 18, 2026. Jean-Charles Soria, senior vice president of oncology within global development at Amgen, will present at the conference. The webcast will be broadcast over the internet simultaneously and will be available to members of the news media, investors and the general public.

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The webcast, as with other selected presentations regarding developments in Amgen’s business given by management at certain investor and medical conferences, can be found on Amgen’s website, www.amgen.com, under Investors. Information regarding presentation times, webcast availability and webcast links are noted on Amgen’s Investor Relations Events Calendar. The webcast will be archived and available for replay for at least 90 days after the event.

(Press release, Amgen, FEB 13, 2026, View Source [SID1234662668])

On February 13, 2026 Alivexis, Inc. (Headquartered in Minato-ku, Tokyo; CEO S. Roy Kimura) reported that it has entered into a Research Collaboration Agreement with OHARA Pharmaceutical Co., Ltd. ("OHARA") to identify small‑molecule compounds for multiple targets selected by OHARA, leveraging Alivexis’ drug discovery platform ModBind and related technologies.

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Under this collaboration, Alivexis will apply its computational drug discovery platform, including ModBind, to support the discovery of novel small‑molecule candidates for multiple targets in the neuroscience field. In addition to in silico evaluations, Alivexis will provide research support, including structural analysis of compound–target interactions, and will work jointly with OHARA to establish experimental systems and perform compound synthesis, evaluation, and optimization.
In support of this drug discovery program, Alivexis will receive a one‑time fee for the use of its computational drug discovery platform, research funding, and may be eligible to receive financial consideration, subject to the terms and conditions of the collaboration agreement.

About ModBind.
ModBind is a proprietary physics-based simulation technology developed by Alivexis that enables high-speed, highly accurate prediction of absolute binding strength between small molecule compounds and target proteins, without the need for experimentally-derived biological activity data. Leveraging ModBind along with other platform technologies, we have already advanced five compounds to clinical candidate status. One program resulted in a licensing agreement with a Swiss company in June 2024, valued at approximately 42.5 billion yen, demonstrating the practical and commercial utility of our technology. In addition, we have conducted multiple joint research projects with pharmaceutical companies, with ModBind serving as the core technology in these collaborations.

In addition, in August 2025, we were selected for the third round of the "GENIAC (Generative AI Accelerator Challenge)" program, a project led by the Ministry of Economy, Trade and Industry (METI) and the New Energy and Industrial Technology Development Organization (NEDO) which aims to strengthen domestic development capabilities in generative AI. By integrating ModBind with AI training, we aim to build and implement a generative AI foundation model for drug discovery that predicts the biological activity of small-molecule compounds with world-leading accuracy.

【CEO S. Roy Kimura’s Comments】
"I am excited to announce the signing of our drug discovery collaboration with OHARA focused on the use of our proprietary and ground-breaking ModBind simulation technology to accelerate early drug discovery for a selected disease target. Through our collaboration, we look forward to gaining further validation of our technology while contributing to the discovery of novel clinical candidate compounds for diseases with significant unmet medical needs."

(Press release, Alivexis, FEB 13, 2026, View Source [SID1234662667])

On February 13, 2026 HanchorBio, Inc. (TPEx: 7827), a global clinical-stage biotechnology company advancing next-generation immunotherapies for oncology and autoimmune diseases, reported that the U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation (ODD) to HCB101 for the treatment of gastric cancer. The designation covers gastric cancer broadly, including advanced gastric adenocarcinoma in both HER2-positive and HER2-negative subtypes. This milestone underscores the significant unmet medical need in gastric cancer and provides important regulatory support for the continued clinical development of HCB101 in this patient population.

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This designation marks the first FDA Orphan Drug Designation for HanchorBio, representing a significant regulatory milestone for the company and further validating its strategy of advancing differentiated immunotherapies in areas of high unmet medical need.

HCB101 is a next-generation CD47–SIRPα pathway inhibitor, engineered as an affinity-optimized and toxicity-mitigated SIRPα-IgG4 Fc fusion protein. The molecule is designed to restore macrophage-mediated phagocytosis and enhance antigen presentation while minimizing the hematologic toxicities that have historically limited earlier CD47-targeting approaches, enabling rational combination with established standards of care.

"Receiving our first FDA Orphan Drug Designation is a major milestone for HanchorBio and important validation of our scientific, regulatory, and development strategy," said Scott Liu, PhD, Founder, Chairman, and CEO of HanchorBio. "Gastric cancer remains an area of profound unmet medical need, and this designation reinforces our commitment to developing differentiated immunotherapies that can meaningfully improve outcomes for patients. This designation strengthens HCB101’s profile as a globally relevant asset and represents a strategically important step as we advance the program toward U.S. and international development. It further supports our ongoing engagement with multinational partners as we explore collaboration and licensing opportunities for HCB101 and our broader immunotherapy pipeline."

Gastric cancer is a rare disease in the United States, with prevalence well below the FDA’s statutory threshold for orphan designation. Despite advances in targeted therapy and immune checkpoint inhibition, outcomes, particularly in the second-line setting, remain poor, with limited durability of response and substantial treatment-related toxicity.

HCB101 is currently being evaluated in multiple ongoing clinical studies, including a Phase 1b/2a trial (NCT06771622) assessing HCB101 in combination with ramucirumab and paclitaxel in second-line advanced gastric cancer. Early clinical findings have demonstrated promising antitumor activity with a safety profile consistent with the molecule’s differentiated design.

Alvin Luk, PhD, MBA, CCRA, President & Chief Medical Officer (Group) and Chief Executive Officer (U.S.A.) of HanchorBio, added, "The FDA’s decision reflects the seriousness of gastric cancer and the clinical rationale underlying HCB101’s development. HCB101’s IgG4-based SIRPα-Fc design was intentionally selected to support repeated dosing and combination strategies as an innate immune checkpoint backbone in solid tumors. In a second-line gastric cancer setting, where standard regimens offer limited durability, the depth of tumor shrinkage and consistency of response observed to date, while remaining compatible with standard ramucirumab-paclitaxel administration, support the continued global advancement of HCB101 for patients with significant unmet need."

Orphan Drug Designation provides certain development incentives, including eligibility for tax credits on qualified clinical trial expenses, exemption from FDA user fees, and the potential for seven years of market exclusivity upon approval in the United States.

HanchorBio plans to continue advancing HCB101 through global clinical development while exploring its potential as a backbone immunotherapy across multiple solid tumor indications.

About HCB101
HCB101 is a rationally engineered SIRPα–IgG4 Fc fusion protein developed on HanchorBio’s FBDB platform to selectively block the CD47–SIRPα innate immune checkpoint while minimizing hematologic toxicity. Unlike earlier anti-CD47 approaches, HCB101 is designed to preserve macrophage-mediated antitumor activity while reducing binding to red blood cells, a limitation that historically constrained the clinical utility of CD47-directed therapies.

HCB101 was engineered using AI-assisted structural modeling to achieve differentiated binding to CD47 on cancer cells while maintaining low affinity for CD47 on red blood cells. Its safety profile, receptor occupancy characteristics, and pharmacologic properties are designed to support integration with established oncology regimens without disrupting standard dosing, safety expectations, or clinical workflows. Across ongoing clinical and translational evaluation, HCB101 has demonstrated consistent target engagement and early antitumor activity as both monotherapy and in combination settings, including tumor types historically considered challenging for CD47-directed therapies.

Together, these attributes position HCB101 as a differentiated innate immune checkpoint backbone with broad potential for a wide variety of combination strategies across solid tumors and hematologic malignancies.

(Press release, Hanchor Bio, FEB 13, 2026, View Source [SID1234662652])

On February 12, 2026 Daiichi Sankyo (TSE: 4568) reported the company has submitted a supplemental New Drug Application (sNDA) to Japan’s Ministry of Health, Labour and Welfare (MHLW) for DATROWAY (datopotamab deruxtecan) for the treatment of adult patients with hormone receptor negative and HER2 negative unresectable or recurrent breast cancer, a subtype commonly referred to as triple negative breast cancer (TNBC).

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DATROWAY is a specifically engineered TROP2 directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo and being developed and commercialized by Daiichi Sankyo in Japan.

The sNDA is based on data from the TROPION-Breast02 phase 3 trial presented at the 2025 European Society for Medical Oncology (#ESMO25) Congress. In the trial, DATROWAY demonstrated a statistically significant and clinically meaningful improvement for the dual primary endpoints of overall survival (OS) and progression-free survival (PFS) compared to investigator’s choice of chemotherapy as first-line treatment for patients with metastatic TNBC for whom immunotherapy was not an option.

"Metastatic triple negative breast cancer is highly aggressive and has one of the worst prognoses of any subtype of breast cancer," said Yuki Abe, PhD, Head of R&D Division in Japan and Head of Research, Daiichi Sankyo. "We are working as quickly as possible with the Japan health authority to make DATROWAY the first TROP2 directed antibody drug conjugate to become available in Japan for first-line triple negative breast cancer, addressing the unmet need for the seventy percent of patients in this setting who are not candidates for immunotherapy."

Additional regulatory submissions for DATROWAY in breast and lung cancer are underway globally.

About TROPION-Breast02
TROPION-Breast02 is a global, multicenter, randomized, open-label phase 3 trial evaluating the efficacy and safety of DATROWAY versus investigator’s choice of chemotherapy (paclitaxel, nab-paclitaxel, capecitabine, carboplatin or eribulin) in patients with previously untreated locally recurrent inoperable or metastatic TNBC for whom immunotherapy was not an option. This included patients whose tumors did not express PD-L1 as well as patients with PD-L1 expressing tumors who could not receive immunotherapy due to prior exposure in early-stage disease, comorbidities or immunotherapy not being accessible in their geography. Enrollment included patients with de novo or recurrent disease, regardless of disease-free interval, and those with poor prognostic factors such as stable brain metastases.

The dual primary endpoints of TROPION-Breast02 are PFS as assessed by blinded independent central review and OS. Secondary endpoints include PFS as assessed by investigator, objective response rate, duration of response, disease control rate, pharmacokinetics and safety.

TROPION-Breast02 enrolled 644 patients at sites in Africa, Asia, Europe, North America and South America. For more information visit ClinicalTrials.gov.

About Triple Negative Breast Cancer
TNBC accounts for approximately 15% of all breast cancer cases, with an estimated 345,000 diagnoses globally each year.1,2 In Japan, an estimated 12,700 cases of TNBC were diagnosed in 2024. 3,4 TNBC is diagnosed more frequently in younger and premenopausal women, and is more prevalent in Black and Hispanic women.5,6,7 Metastatic TNBC is the most aggressive type of breast cancer and has one of the worst prognoses, with median OS of just 12 to 18 months and only about 15% of patients living five years following diagnosis.8,9

While some breast cancers may test positive for estrogen receptors, progesterone receptors or overexpression of HER2, TNBC tests negative for all three.1 Due to its aggressive nature and absence of common breast cancer receptors, TNBC is characteristically difficult to treat.1 For patients with metastatic disease with PDL1 expressing tumors, the addition of immunotherapy to chemotherapy has improved outcomes in the firstline setting.2,3 However, for approximately 70% of patients with metastatic TNBC who are not candidates for immunotherapy, chemotherapy remains the only approved first-line treatment. 4,5

TROP2 is a protein broadly expressed in several solid tumors, including TNBC.6 TROP2 is associated with increased tumor progression and poor survival in patients with breast cancer.7,8

About DATROWAY
DATROWAY (datopotamab deruxtecan; datopotamab deruxtecan-dlnk in the U.S. only) is a TROP2 directed ADC. Designed using Daiichi Sankyo’s proprietary DXd ADC Technology, DATROWAY is one of six DXd ADCs in the oncology pipeline of Daiichi Sankyo, and one of the most advanced programs in AstraZeneca’s ADC scientific platform. DATROWAY is comprised of a humanized anti-TROP2 IgG1 monoclonal antibody, developed in collaboration with Sapporo Medical University, attached to a number of topoisomerase I inhibitor payloads (an exatecan derivative, DXd) via tetrapeptide-based cleavable linkers.

DATROWAY (6 mg/kg) is approved in more than 40 countries/regions worldwide for the treatment of adult patients with unresectable or metastatic HR positive, HER2 negative (IHC 0, IHC 1+ or IHC 2+/ISH-) breast cancer who have received prior endocrine-based therapy and chemotherapy for unresectable or metastatic disease based on the results from the TROPION-Breast01 trial.

About the DATROWAY Clinical Development Program
A comprehensive global clinical development program is underway with more than 20 trials evaluating the efficacy and safety of DATROWAY across multiple cancers, including NSCLC, TNBC and urothelial cancer. The program includes eight phase 3 trials in lung cancer, five phase 3 trials in breast cancer and one phase 2/3 trial in urothelial cancer evaluating DATROWAY as a monotherapy and in combination with other cancer treatments in various settings.

About the Daiichi Sankyo and AstraZeneca Collaboration
Daiichi Sankyo and AstraZeneca entered into a global collaboration to jointly develop and commercialize ENHERTU (trastuzumab deruxtecan) in March 2019 and DATROWAY in July 2020, except in Japan where Daiichi Sankyo maintains exclusive rights for each ADC. Daiichi Sankyo is responsible for the manufacturing and supply of ENHERTU and DATROWAY.

About the ADC Portfolio of Daiichi Sankyo
The Daiichi Sankyo ADC portfolio consists of eight ADCs in clinical development crafted from ADC technology discovered in-house by Daiichi Sankyo.

The DXd ADC Technology platform of Daiichi Sankyo consists of seven ADCs in clinical development where each ADC is comprised of a monoclonal antibody attached to a number of topoisomerase I inhibitor payloads (an exatecan derivative, DXd) via tetrapeptide-based cleavable linkers. The DXd ADCs include ENHERTU and DATROWAY, which are being jointly developed and commercialized globally with AstraZeneca, and ifinatamab deruxtecan (I-DXd), raludotatug deruxtecan (R-DXd) and patritumab deruxtecan (HER3-DXd), which are being jointly developed and commercialized globally with Merck & Co., Inc, Rahway, NJ, USA. DS-3939 and DS3790 are being developed by Daiichi Sankyo.

An additional ADC being developed by Daiichi Sankyo is DS3610, which consists of an antibody attached to a novel payload that acts as an agonist of STING.

Ifinatamab deruxtecan, raludotatug deruxtecan, patritumab deruxtecan, DS-3939, DS3610 and DS3790 are investigational medicines that have not been approved for any indication in any country. Safety and efficacy have not been established.

(Press release, Daiichi Sankyo, FEB 12, 2026, View Source [SID1234665015])