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 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 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 Medicenna Therapeutics Corp. ("Medicenna" or the "Company") (TSX: MDNA, OTCQX: MDNAF), a clinical-stage immunotherapy company focused on the development of Superkines targeting cancer, autoimmune, and inflammatory diseases, reported financial results and corporate highlights for the fiscal quarter ended December 31, 2025, as well as anticipated corporate milestones.

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"We delivered strong clinical results in 2025 with our ABILITY-1 trial and 2026 is shaping up to be a milestone-rich year across our pipeline," said Dr Fahar Merchant, President and CEO of Medicenna. "MDNA11 continues to deliver best-in-class efficacy results in multiple solid tumors, following failure of other block-buster immunotherapies where the needs of cancer patients remain largely unfulfilled. MDNA113, our tumor targeted bi-functional conditionally activated anti-PD1-IL-2, is advancing towards IND enabling studies and has demonstrated solid efficacy signals in pre-clinical models and excellent tolerability in preliminary non-human primate studies. This year, we plan to file an IND for MDNA113 and arrange an End of Phase 1 meeting with the FDA for a potential registrational trial with MDNA11. As we execute on these programs, we remain committed on advancing high-impact opportunities that have the potential to improve standards of care for patients with cancer, drive partnerships, strengthen our balance sheet and build shareholder value."

PROGRAM AND BUSINESS UPDATE
Highlights for the three months ended December 31, 2025, along with recent developments, include:

MDNA11: ‘β-Enhanced Not-α’ Interleukin 2 Super Agonist

MDNA11 Clinical Data Update:

On January 16, 2026, Medicenna updated expansion cohort data demonstrating MDNA11’s best-in-class anti-tumor activity. When administered as a 2L/3L systemic treatment or as next line following resistance to checkpoint therapy, MDNA11 achieved a monotherapy objective response rate ("ORR") of 36% and a disease control rate ("DCR") of 86% (N=14), and when combined with pembrolizumab ORR was 43% and DCR was 72% (N=14).
ABILITY-1 Enrollment and Update:

Consequently, as a result of these compelling data, Medicenna is completing enrollment in the expansion portions of the ABILITY-1 study by enrolling patients where MDNA11 will be administered as 2/3L Tx or immediately following checkpoint-resistance.

Tumor types currently enrolling are: MSI-H, TMB-H, cutaneous melanoma, endometrial (combination only), non-small cell lung cancer (combination only), and colorectal cancer (mono- and combination in TMB-H and MSI-H cohorts). NSCLC and colorectal cancer cohorts have been added due to prior data demonstrating strong potential of IL-2 therapy in these cancers and have blockbuster market opportunities. Medicenna anticipates sharing updated clinical results from the ABILITY-1 study in H2 2026.

Medicenna anticipates completing enrollment of expansion cohorts in the ABILITY-1 study and is planning for an end-of-phase 1 meeting with the FDA, allowing for alignment regarding potential registrational trials.
NEO-CYT Trial:

In collaboration with the Fondazione Melanoma Onlus, the NEO-CYT Trial is a randomized, multi-centre neoadjuvant study in high-risk, resectable Stage III melanoma, evaluating MDNA11 in combination with nivolumab, with or without ipilimumab.

NEO‑CYT is designed to prospectively evaluate the potential of MDNA11 to enhance the efficacy of standard-of-care cancer immunotherapy in the neoadjuvant setting. Specifically, whether Medicenna’s best‑in‑class IL‑2 agonist can deepen neoadjuvant pathologic responses predictive of patient outcomes when added to established anti-PD‑1 ± anti-CTLA‑4 regimens at a time when the tumor is still present to optimize the anti-tumor immune response.

Medicenna anticipates sharing interim clinical data from this study in neoadjuvant melanoma in H2 2026.

MDNA113: First-in-Class Tumor-anchored and Activatable ‘Masked’ Anti-PD-1-IL-2 BiSKIT

MDNA113 is our most advanced pre-clinical asset encompassing both, the T-MASK and BiSKIT platforms. It is a novel first-in-class tumor targeted and activatable bifunctional anti-PD1-IL-2 superkine.
MDNA113 is advancing through preclinical development with plans to commence a first-in-human trial in H2 2026.
Non-human primate studies are currently underway, with updated data demonstrating its potential to dramatically widen the therapeutic index, and has shown a favorable safety profile in non-human primates at the highest tested dose of 30 mg/kg, supporting the potential for human dosing comparable to approved anti-PD-1 therapies.

Bizaxofusp (formerly MDNA55): IL-4 Superkine – Treatment of Recurrent Glioblastoma ("rGBM")

Medicenna’s phase 3 ready asset for rGBM, bizaxofusp, to-date, has been tested in 118 patients with high grade gliomas (including 112 patients with rGBM) and most recently completed a successful Phase 2b (N=44) trial for nonresectable rGBM where it demonstrated a doubling of median overall survival ("mOS") to 13.6 months in the WHO-defined IDHWT high-dose population compared to the standard-of-care mOS of 7 months.
Medicenna will present updated internal and external data sets related to bizaxofusp (MDNA55) at the 7th Annual Glioblastoma Development Summit to be held in Boston from 17-19 February 2026.
Title: Surmounting Barriers in Non-resectable Recurrent Glioblastoma with a Single Treatment of Bizaxofusp, an Engineered IL-4R Directed Fusion Protein
Time: Thursday, February 19, 2026, at 10:00 AM Eastern Time
Presenter: Dr. Fahar Merchant, President & CEO of Medicenna Therapeutics
Medicenna is actively pursuing strategic partnerships to advance the program into a registrational trial, and is preparing the program for commercialization and its subsequent launch in various countries where marketing authorization is granted.

CHANGE TO BOARD OF DIRECTORS

Medicenna announced changes to its Board of Directors. Mr. Richard Sutin and Mr. Angelos Georgakis have been appointed to the Board of Directors of the Company. Mr. Sutin and Mr. Georgakis’s appointments to the Board follow the retirement of Ms. Karen Dawes, who has served on the Board since 2019, most recently as Chair of the Compensation Committee and as a member of the Audit Committee.

QUARTERLY FINANCIAL RESULTS

Medicenna exited the quarter ended December 31, 2025, with cash and cash equivalents of $10.6 million. Based on the Company’s current operating plan, these funds are expected to be sufficient to fund planned operations into the third quarter of 2026.

For the three months ended December 31, 2025, the Company reported total operating costs of $5.6 million compared to $5.1 million for the three months ended December 31, 2024. The increase was primarily attributable to a $0.5 million increase in research and development ("R&D") expenditures related to higher MDNA11 clinical trial costs in the current quarter relative to the comparable period. General and administrative ("G&A") costs were consistent year over year.

Net loss for the quarter ended December 31, 2025, was $4.4 million, or $0.05 per share, compared to a net loss of $5.2 million, or $0.07 per share, for the three months ended December 31, 2024. The $0.8 million decrease in net loss was primarily due to a $2.9 million increase in the gain on the fair value of the derivative warrant liability, partially offset by a $1.3 million decrease in foreign exchange gain, a $0.5 million increase in R&D expenses, and a $0.3 million decrease in finance income.

R&D expenses were $4.1 million for the quarter ended December 31, 2025, compared to $3.6 million for the same period in 2024. The increase was primarily driven by higher clinical costs associated with the expansion of the MDNA11 ABILITY-1 study to additional clinical sites and increased patient enrollment, as well as the initiation of the NEO-CYT trial during the quarter. G&A expenses were $1.5 million for the quarter ended December 31, 2025, consistent with $1.5 million for the same period in 2024, reflecting stable operating activities year over year.

Medicenna’s financial statements for the three and nine months ended December 31, 2025, and the related management’s discussion and analysis (MD&A) will be available on SEDAR+ at www.sedarplus.ca.

(Press release, Medicenna Therapeutics, FEB 13, 2026, View Source [SID1234663800])

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])