TriSalus Life Sciences Announces Pricing of $40.0 Million Public Offering

On February 20, 2026 TriSalus Life Sciences, Inc. (Nasdaq: TLSI) ("TriSalus" or the "Company"), an oncology focused medical technology company advancing novel drug delivery technologies alongside standard-of-care therapies to improve outcomes for patients with solid tumors, reported it has priced its previously announced underwritten public offering of 9,756,100 shares of its common stock at a public offering price of $4.10 per share. All of the shares in the offering are being sold by TriSalus. In addition, TriSalus has granted the underwriter a 30-day option to purchase up to 1,463,415 shares of common stock, which equals 15% of the total number of shares of common stock sold in the offering, at the public offering price, less underwriting discounts and commissions. The gross proceeds to TriSalus from the offering are expected to be approximately $40.0 million, before deducting underwriting discounts and commissions and other offering expenses payable by TriSalus. The offering is expected to close on or about February 23, 2026, subject to the satisfaction of customary closing conditions.

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Lake Street Capital Markets is acting as the sole book-runner for the proposed offering.

The shares are being offered and sold by the Company pursuant to an effective shelf registration statement on Form S-3 (File No. 333-291509) previously filed with the U.S. Securities and Exchange Commission (the "SEC") on November 13, 2025 and declared effective by the SEC on December 4, 2025. The offering of such shares is being made only by means of a prospectus supplement that forms a part of the registration statement. A preliminary prospectus supplement and accompanying base prospectus relating to the offering have been filed with the SEC. A final prospectus supplement and accompanying base prospectus related to the offering will be filed with the SEC and made available on the SEC’s website. Copies of the final prospectus supplement, when available, and the accompanying base prospectus relating to the offering may also be obtained from Lake Street Capital Markets, LLC at 121 South Eighth Street, Suite 1000, Minneapolis, MN 55402, or e-mail at [email protected].

This press release shall not constitute an offer to sell or the solicitation of an offer to buy any of the securities described herein, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation, or sale would be unlawful prior to registration or qualification under the securities laws of any such state or other jurisdiction.

(Press release, TriSalus Life Sciences, FEB 20, 2026, View Source [SID1234662826])

enGene to Participate in Upcoming Investor Conferences

On February 20, 2026 enGene Holdings Inc. (Nasdaq: ENGN or "enGene"), a clinical-stage, non-viral genetic medicines company, reported that management will participate in the following investor conferences:

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Oppenheimer 36th Annual Healthcare Life Sciences Conference
Date: Thursday, February 26, 2026
Format: Presentation
Time: 1:20 p.m. ET

Leerink Partners 2026 Global Healthcare Conference
Date: Monday, March 9, 2026
Format: Fireside chat
Time: 8:00 a.m. ET

Barclays 28th Annual Global Healthcare Conference
Date: Tuesday, March 10, 2026
Format: Fireside chat
Time: 9:00 a.m. ET

Citizens Life Sciences Conference
Date: Wednesday, March 11, 2026
Format: Fireside chat
Time: 1:40 p.m. ET

A live webcast of these events can be accessed on the "Events and Presentations" page under the "Investors" section of the enGene website at www.engene.com and will be archived there for 90 days.

(Press release, enGene, FEB 20, 2026, View Source [SID1234662827])

ImmunityBio Partners with Biopharma and Cigalah Healthcare to Launch ANKTIVA® in Saudi Arabia for Bladder and Lung Cancer Patients

On February 20, 2026 ImmunityBio, Inc. (NASDAQ: IBRX), a commercial-stage immunotherapy company, reported a partnership with Biopharma and Cigalah, two of the largest and most respected healthcare commercial and distribution companies in the Middle East, to launch ANKTIVA (nogapendekin alfa inbakicept) in Saudi Arabia and, over time, across the broader MENA region.

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Under the agreement, Biopharma and Cigalah Healthcare will support the commercialization and distribution of ANKTIVA in two indications: In combination with Bacillus Calmette-Guérin (BCG) for patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) carcinoma in situ, with or without papillary disease; and in combination with a checkpoint inhibitor for patients with metastatic non-small cell lung cancer.

ImmunityBio has established a wholly owned subsidiary in Saudi Arabia, to support its distribution, commercialization, and growth across the Middle East and North Africa.

"We’re pleased to partner with two of the largest healthcare and distribution companies to launch to ANKTIVA to patients in Saudi Arabia and, across the broader Middle East and North Africa region," said Richard Adcock, President and CEO of ImmunityBio. "Their combined world-class commercial infrastructure and proven track record in bringing innovative therapies to patients with serious diseases will help accelerate access to ANKTIVA and support our commitment to serving physicians and health systems throughout the region, including Saudi Arabia, United Arab Emirates, Qatar and Egypt."

The MENA region has significant unmet needs for the treatment of serious cancers, which are on the rise in many countries. Lung cancer is among the most prevalent cancers in Saudi Arabia and is the third most common cancer among males over 45 years of age, according to the Saudi Ministry of Health1. Lebanon has the highest incidence of bladder cancer cases globally, while Syria and Egypt also rank among the countries with the greatest burden of the disease.2

"At Cigalah and Biopharma our goal is to ensure that physicians and their patients have ready access to the most advanced therapies available for the most difficult-to-treat diseases like cancer," said Tamer Eissa, General Manager, Biopharma. "That is exactly what ImmunityBio brings with ANKTIVA, and we are pleased to partner with them to help extend the lives of bladder and lung cancer patients in Saudi Arabia, and the rest of the Middle Eastern countries we serve."

"We have just returned from a highly productive trip to the Middle East and met with the leadership of Saudi FDA and the Emirates Drug Establishment (EDE) to advance the development of ANKTIVA for expanded patient and indication access to the Middle East," said Dr. Patrick Soon-Shiong, Founder, Executive Chairman, and Global Chief Scientific and Medical Officer of ImmunityBio. "I am highly encouraged by the collaborative engagement of the leadership of the regulatory authorities in the region and their desire to interact with ImmunityBio to expand access of the BioShield platform across multiple tumor types for their citizens. The initial approval by Saudi FDA for ANKTIVA in combination with checkpoint inhibitors, in patients with checkpoint failures in lung cancer has catalyzed the opportunity to build on Immunotherapy 2.0 across multiple tumor types with ANKTIVA as the backbone to NK cell therapy."

ANKTIVA received U.S. Food and Drug Administration approval in April 2024 for use in combination with BCG for the treatment of BCG-unresponsive NMIBC CIS, with or without papillary tumors. ANKTIVA was subsequently approved for the same indication by the UK Medicines and Healthcare products Regulatory Agency in July 2025 and the European Commission in February 2026, as well as the Saudi Food and Drug Authority (SFDA) in January 2026; in addition, the SFDA approved ANKTIVA in combination with a checkpoint inhibitor for the treatment of metastatic non-small cell lung cancer.

About ANKTIVA (nogapendekin alfa inbakicept)
The cytokine interleukin-15 (IL-15) plays a crucial role in the immune system by affecting the development, maintenance, and function of key immune cells—NK and CD8+ killer T cells—that are involved in killing cancer cells. By activating NK cells, ANKTIVA overcomes the tumor escape phase of clones resistant to T cells and restores memory T cell activity with resultant prolonged duration of complete response. ANKTIVA is a first-in-class IL-15 agonist IgG1 fusion complex, consisting of an IL-15 mutant (IL-15N72D) fused with an IL-15 receptor alpha, which binds with high affinity to IL-15 receptors on NK, CD4+, and CD8+ T cells. This fusion complex of ANKTIVA mimics the natural biological properties of the membrane-bound IL-15 receptor alpha, delivering IL-15 by dendritic cells and driving the activation and proliferation of NK cells with the generation of memory killer T cells that have retained immune memory against these tumor clones.

Saudi Arabia Indication and Usage
BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) carcinoma in situ:
ANKTIVA in combination with Bacillus Calmette-Guérin (BCG) is indicated for the treatment of adult patients with high-risk BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) of carcinoma in situ (CIS) with or without papillary disease.

Non-small cell lung cancer (NSCLC):
ANKTIVA is indicated in combination with immune checkpoint inhibitors for the treatment of adult patients with metastatic NSCLC with disease progression on or after standard of care (immune checkpoint inhibitors alone or in combination with chemotherapy). Patients with actionable genomic alteration should have disease progression on approved therapy for these alterations, before using ANKTIVA in combination with immune checkpoint inhibitors.

This indication is approved under accelerated approval based on the increase of ALC associated with overall survival in single arm study. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory clinical trials.

Limitation of use:
Insufficient evidence of benefit for the use of ANKTIVA in combination with immune checkpoint inhibitors in NSCLC with baseline ALC < 1.0 × 10³/μL. Experience is limited to patients with a baseline absolute lymphocyte count (ALC) ≥ 1.0 × 10³/μL who are maintained above this level after treatments.

IMPORTANT SAFETY INFORMATION

INDICATION AND USAGE:

ANKTIVA is an interleukin-15 (IL-15) receptor agonist indicated with Bacillus Calmette-Guérin (BCG) for the treatment of adult patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors.

WARNINGS AND PRECAUTIONS: Risk of Metastatic Bladder Cancer with Delayed Cystectomy. Delaying cystectomy can lead to the development of muscle-invasive or metastatic bladder cancer, which can be lethal. If patients with CIS do not have a complete response to treatment after a second induction course of ANKTIVA with BCG, reconsider cystectomy.

DOSAGE AND ADMINISTRATION: For Intravesical Use Only. Do not administer by subcutaneous or intravenous routes.

Please see the complete Prescribing Information for ANKTIVA at Anktiva.com.

(Press release, ImmunityBio, FEB 20, 2026, View Source [SID1234662828])

Calquence plus venetoclax approved in the US as first all-oral, fixed-duration combination for patients with chronic lymphocytic leukaemia in the 1st-line setting

On February 20, 2026 AstraZeneca reported that Calquence (acalabrutinib) in combination with venetoclax has been approved in the US as the first all-oral, fixed-duration regimen for the treatment of adult patients with chronic lymphocytic leukaemia (CLL) and small lymphocytic lymphoma (SLL).

The approval by the US Food and Drug Administration (FDA) was based on positive results from the AMPLIFY Phase III trial, which were presented at the American Society of Hematology (ASH) (Free ASH Whitepaper) 2024 Annual Meeting and published in The New England Journal of Medicine.1,2

CLL is the most common type of leukaemia in adults.3 An estimated 18,500 people were treated for CLL in the 1st-line setting in the US in 2024.4

Jennifer Brown, MD, PhD, Director of the CLL Center of the Division of Hematologic Malignancies, Dana-Farber Cancer Institute, and the Worthington and Margaret Collette Professor of Medicine at Harvard Medical School, and principal investigator of the AMPLIFY trial, said: "The continuous regimens frequently used to treat chronic lymphocytic leukaemia often come with side effects that may become burdensome to patients over time. The US approval of the Calquence combination offers patients an all-oral, 14-month, fixed-duration treatment option that is highly effective and well-tolerated, and gives physicians greater flexibility to tailor treatment plans for individual patient needs and goals."

Dave Fredrickson, Executive Vice President, Oncology Haematology Business Unit, AstraZeneca, said: "Today’s approval delivers the first all-oral, fixed-duration BTK inhibitor-based regimen in the US for the treatment of chronic lymphocytic leukaemia. This Calquence combination has the potential to meaningfully change 1st-line chronic lymphocytic leukaemia treatment decisions and underscores our commitment to improving on the current standard of care for people living with blood cancers."

Gwen Nichols, MD, Chief Medical Officer of Blood Cancer United, formerly The Leukemia & Lymphoma Society, said: "Managing an incurable blood cancer that progresses slowly can often feel indefinite and overwhelming. We welcome new treatment options that may ease the burden, restore a sense of control and offer renewed hope for those navigating life with chronic lymphocytic leukaemia."

Results from the AMPLIFY Phase III trial showed 77% of patients treated with Calquence plus venetoclax were progression free at three years, versus 67% of patients treated with standard-of-care chemotherapy (investigator’s choice of fludarabine-cyclophosphamide-rituximab or bendamustine-rituximab).2 Median progression-free survival (PFS) was not reached versus 47.6 months for chemoimmunotherapy.2 Further, Calquence plus venetoclax reduced the risk of disease progression or death by 35% compared to chemoimmunotherapy (based on hazard ratio 0.65; 95% confidence interval 0.49-0.87; p=0.0038).2

Calquence plus venetoclax is approved in the European Union, Canada, UK and several other countries, and regulatory applications for the regimen based on the AMPLIFY results are currently under review in additional countries.

The safety and tolerability of Calquence was consistent with its known safety profile, and no new safety signals were identified.

Notes

Chronic lymphocytic leukaemia (CLL)
CLL is the most prevalent type of leukaemia in adults, with an estimated 40,000 people being treated for CLL in the first line in the US, UK, France, Germany, Spain, Italy, Japan and China in 2024.4 Although some people with CLL may not experience any symptoms at diagnosis, others may experience symptoms, such as weakness, fatigue, weight loss, chills, fever, night sweats, swollen lymph nodes and abdominal pain.5 In CLL, there is an accumulation of abnormal lymphocytes within the blood, bone marrow and lymph nodes. As the number of abnormal cells increases, there is less room within the marrow for the production of normal white blood cells, red blood cells and platelets.3 This could result in infection, anaemia and bleeding. B-cell receptor signalling through BTK is one of the essential growth pathways for CLL.

AMPLIFY
AMPLIFY is a randomised, global, multi-centre, open-label Phase III trial evaluating the efficacy and safety of Calquence in combination with venetoclax, with or without obinutuzumab, compared to investigator’s choice of chemoimmunotherapy (fludarabine-cyclophosphamide-rituximab or bendamustine-rituximab) in adult patients with previously untreated CLL without del(17p) or TP53 mutation.6 Patients were randomised 1:1:1 to receive either Calquence plus venetoclax, or Calquence plus venetoclax with obinutuzumab for a fixed duration, or standard-of-care chemoimmunotherapy.6 Both the Calquence containing arms were administered for a fixed duration of 14 cycles (each 28 days), and the standard-of-care chemoimmunotherapy was administered for 6 cycles.6

The primary endpoint is PFS in the Calquence and venetoclax arm as assessed by an Independent Review Committee, and PFS is a key secondary endpoint in the Calquence plus venetoclax with obinutuzumab arm.7 Other key secondary endpoints include overall survival (OS) and undetectable measurable residual disease.6 The trial includes 27 countries across North and South America, Europe, Asia and Oceania.6

The AMPLIFY trial enrolled patients from 2019 to 2021, continuing through the COVID-19 pandemic.6

Calquence
Calquence (acalabrutinib) is a second-generation, selective inhibitor of Bruton’s tyrosine kinase (BTK). Calquence binds covalently to BTK, thereby inhibiting its activity.7 In B-cells, BTK signalling results in activation of pathways necessary for B-cell proliferation, trafficking, chemotaxis and adhesion.

Calquence is approved for the treatment of chronic lymphocytic leukaemia (CLL) and small lymphocytic lymphoma (SLL) in the US, Japan and China, and approved for CLL in Europe and many other countries. Calquence is also approved as a fixed-duration treatment for the treatment of adult patients with previously untreated CLL in combination with venetoclax in the US, and in combination with venetoclax, with or without obinutuzumab, in Europe, Canada, the U.K. and several other countries. Calquence is also approved for the treatment of adult patients with previously untreated mantle cell lymphoma (MCL) in the US, Europe, Japan and other countries. It is also approved for the treatment of adult patients with MCL who have received at least one prior therapy in China and several other countries.

As part of an extensive clinical development programme, Calquence is currently being evaluated as a single treatment and in combination with standard-of-care chemoimmunotherapy for patients with multiple B-cell blood cancers, including CLL, MCL and diffuse large B-cell lymphoma.

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(Press release, AstraZeneca, FEB 20, 2026, View Source [SID1234662814])

Calidi Biotherapeutics Presents Data on its New Approach to Bispecific T-Cell Engagers (BiTEs) Using its RedTail Platform at the 2026 AACR-IO Conference

On February 20, 2026 Calidi Biotherapeutics, Inc. (NYSE American: CLDI) ("Calidi" or the "Company"), a biotechnology company pioneering the development of targeted genetic medicines, reported data on its novel approach to the use of BiTEs in solid tumors by utilizing its systemically delivered RedTail platform at the AACR (Free AACR Whitepaper) Immuno-Oncology (AACR-IO) conference being held in Los Angeles, California. A link to the poster is available here and on the company’s website.

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RedTail is Calidi’s systemically delivered virotherapy platform designed to selectively target tumors, remodel the tumor microenvironment (TME), and enable high-level expression of therapeutic genetic payloads directly within the tumor. CLD-401, the lead candidate derived from the RedTail platform, is engineered to express high levels of IL‑15 superagonist (IL-15 SA), a known T-cell activator, in the TME.

In data presented at the meeting, Calidi demonstrated RedTail viruses that could express both a functional BiTE, capable of binding targeted solid tumor cells, and IL-15 SA at high concentrations, allowing for simultaneous alteration of the TME and T-cell activation and introduction into the TME of a solid-tumor targeting BiTE. BiTEs have shown exceptional efficacy in hematological malignancies but have failed to show clinical benefit in solid tumors where the TME inhibits T-cell activity. By remodeling the TME and driving T-cell activation while expressing a tumor-localized BiTE, RedTail may overcome the historical limitations of BiTEs in solid tumors.

"The RedTail platform allows for the systemic and targeted delivery of genetic payloads to distal sites of disease," said Eric Poma, PhD, Chief Executive Officer of Calidi. "Once at the target, RedTail can induce high levels of expression of one or more genetic payloads, representing a major advance in the delivery of genetic medicines."

"The data presented today highlight the ability of the RedTail platform to functionally overexpress complex biologics likes BiTEs and cytokines directly within the tumor microenvironment" said Antonio F. Santidrian, PhD, Chief Scientific Officer and Head of Technical Operations at Calidi. "Simultaneous tumor-localized expression of a T-cell activator and BiTE via RedTail can remodel the TME to allow for T-cell engagement precisely where it is needed."

Calidi is currently conducting IND-enabling studies with CLD-401, the first lead candidate from its RedTail platform. The company anticipates submitting an Investigational New Drug (IND) application for CLD-401 by the end of 2026. The Company continues to expand the functionality of the RedTail platform and is also actively pursuing strategic partnerships to accelerate clinical development and broaden the impact of its RedTail platform.

(Press release, Calidi Biotherapeutics, FEB 20, 2026, View Source [SID1234662815])