Uncategorized – Page 382 – 1stOncology™: Cancer Intelligence Service

10x Genomics to Participate in the 46th Annual TD Cowen Health Care Conference

On February 19, 2026 10x Genomics, Inc. (Nasdaq: TXG), a leader in single cell and spatial biology, reported that members of its management team will participate in a fireside chat at the TD Cowen 46th Annual Health Care Conference on Tuesday, March 3, at 11:50 a.m. Eastern Time.

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Interested parties may access a live webcast of the fireside chat on the "Investors" section of the company’s website at: View Source The webcast will be archived and available for replay for at least 30 days after the event.

(Press release, 10x Genomics, FEB 19, 2026, View Source [SID1234662801])

Entry into a Material Definitive Agreement

On February 19, 2026, Moleculin Biotech, Inc. (the "Company") entered into warrant exercise inducement offer letters (each, an "Inducement Letter") with holders of certain existing warrants (the "Holders") to purchase up to 2,122,652 shares of Company common stock with an exercise price of $3.90 per share (the "Existing Warrants").

Pursuant to the Inducement Letter, the Holders agreed to exercise the Existing Warrants, and the Company agreed to issue the Holders new warrants to purchase up to a number of shares of Company common stock equal to 300% of the number of shares of Company common stock underlying the exercised Existing Warrants, comprised of new Series H warrants to purchase up to 6,367,956 shares of Company common stock (the "Inducement Warrants" and the shares of Company common stock underlying the Inducement Warrants, the "Inducement Warrant Shares") with an exercise term of five years from the initial exercise date.

The issuance and/or resale of the shares of Company common stock underlying the Existing Warrants have been registered pursuant to effective registration statements on Form S-1 (File No. 333-287727) and Form S-3 (File No. 333-290418). The Company anticipates receiving aggregate gross proceeds of up to approximately $8.3 million from the exercise of the Existing Warrants before deducting fees and other expenses payable by it.

Each Inducement Warrant has an initial exercise price per share equal to the lesser of (i) $3.90, and (ii) the lowest volume weighted average price of the Company common stock on any trading day during the five trading day period immediately following the public announcement of the Company entering into the Inducement Letters with the Holders, will be exercisable upon the receipt of shareholder approval of the issuance of the Inducement Warrant Shares, and may be exercised for a period of five years from such approval. If while the Inducement Warrants are outstanding, the Company issues or sells, or is deemed to have issued or sold, any common stock and/or common stock equivalents other than in connection with certain exempt issuances, at a purchase price per share less than the exercise price of the Inducement Warrants in effect immediately prior to such issuance or sale or deemed issuance or sale, then immediately after such issuance or sale or deemed issuance or sale, the exercise price of the Inducement Warrants then in effect will be reduced to an amount equal to the new issuance price, subject to a floor price of $0.962.

The Inducement Warrants may only be exercised on a cashless basis if there is no registration statement registering, or the prospectus contained therein is not available for, the resale of the shares of common stock underlying the Inducement Warrants by the Holders. The Holders of an Inducement Warrant may not exercise any such warrants to the extent that such exercise would result in the number of shares of common stock beneficially owned by such Holders and its affiliates exceeding 4.99% or 9.99% (at the election of the Holders) of the total number of shares of common stock outstanding immediately after giving effect to the exercise, which percentage may be increased or decreased at the Holders’ election not to exceed 9.99% (the "Beneficial Ownership Limitation"). In the event of certain fundamental transactions (as defined in the Inducement Warrants), the Holders of the Inducement Warrants will have the right to receive the Black Scholes value of the Inducement Warrants calculated pursuant to a formula set forth in the Inducement Warrants, payable either in cash or in the same type or form of consideration that is being offered and being paid to the Holders of common stock.

The Company agreed to file a registration statement on Form S-3 (or other appropriate form, including Form S-1, if it is not then Form S-3 eligible) providing for the resale of the Inducement Warrant Shares issuable upon the exercise of the Inducement Warrants (the "Resale Registration Statement"), on or before March 31, 2026, and to use commercially reasonable efforts to have such Resale Registration Statement declared effective by the SEC by April 30, 2026 and to keep the Resale Registration Statement effective at all times until no Holders of the Inducement Warrants own any Inducement Warrant Shares.

Roth Capital Partners, LLC served as financial advisor for the transaction and received as compensation for such services a fee of 7.0% of the gross proceeds the Company received from the warrant inducement of the Existing Warrants and reimbursement of $50,000 in legal fees.

The representations, warranties and covenants contained in the Inducement Letter were made solely for the benefit of the parties to the Inducement Letter. In addition, such representations, warranties and covenants: (i) are intended as a way of allocating the risk between the parties to such agreements and not as statements of fact, and (ii) may apply standards of materiality in a way that is different from what may be viewed as material by stockholders of, or other investors in, the Company. Accordingly, the Inducement Letter is filed with this report only to provide investors with information regarding the terms of transaction, and not to provide investors with any other factual information regarding the Company. Information concerning the subject matter of the representations and warranties may change after the date of the Inducement Letter, which subsequent information may or may not be fully reflected in public disclosures.

The forms of the Inducement Warrant and Inducement Letter are filed as Exhibits 4.1 and 10.1, respectively, to this Current Report on Form 8-K. The foregoing summaries of the terms of these documents are subject to, and qualified in their entirety by, such documents, which are incorporated herein by reference.

(Filing, Moleculin, FEB 19, 2026, View Source [SID1234662819])

ImmunityBio Expands Access to ANKTIVA® in EU with New Distribution Partnership and Opens Irish Subsidiary to Support European Launch

On February 19, 2026 ImmunityBio, Inc. (NASDAQ: IBRX), a commercial-stage immunotherapy company, reported a partnership with Accord Healthcare to provide access to ANKTIVA (nogapendekin alfa inbakicept) in combination with Bacillus Calmette-Guérin (BCG) for eligible patients in the European Union with BCG-unresponsive non-muscle invasive bladder cancer carcinoma in situ (NMIBC CIS), with or without papillary disease. ImmunityBio also announced the establishment of an Irish subsidiary in Dublin to support the company’s distribution and commercialization strategy throughout Europe.

"Our partnership with Accord marks a significant step in our European growth strategy and our mission to redefine cancer care," said Richard Adcock, President and CEO of ImmunityBio. "Accord’s scale, oncology leadership, and commercial reach support our goals to broaden patient access to ANKTIVA and unlock its full commercial potential in Europe."

As part of the partnership, Accord Healthcare will utilize over 100 Sales, Medical, and Marketing professionals to drive commercialization of ANKTIVA in the UK, European Union, as well as European Free Trade Association members Iceland, Liechtenstein, and Norway.

"Our partnership with ImmunityBio reflects our shared commitment to expanding access to innovative cancer therapies for patients in Europe," said Paul Tredwell, Global CEO at Accord Healthcare. "ANKTIVA represents an important advancement for eligible patients with BCG-unresponsive NMIBC CIS, and we are pleased to support its introduction across our markets."

"With approvals now spanning 33 countries, ImmunityBio has expanded global access to ANKTIVA for those with BCG-unresponsive NMIBC CIS, with or without papillary disease," said Dr. Patrick Soon-Shiong, Founder, Executive Chairman, and Global Chief Scientific and Medical Officer of ImmunityBio. "The 71% complete response rate and the durability of those responses support ANKTIVA’s role as a foundational backbone of next-generation immunotherapy for bladder cancer. Our goal is to further broaden access by rapidly completing the randomized trial in patients with BCG-naïve disease. In parallel, we have submitted our response to the U.S. FDA’s request for additional data related to BCG-unresponsive papillary-only NMIBC, and we await the Agency’s review."

ANKTIVA in combination with BCG for the treatment of BCG-unresponsive NMIBC CIS is now authorized across four major regulatory jurisdictions, encompassing 33 countries. These approvals include the United States (FDA, April 2024), the United Kingdom (MHRA, July 2025), the Kingdom of Saudi Arabia (SFDA accelerated approval, January 2026), and the European Union, where the European Commission granted conditional marketing authorization in February 2026 covering 27 EU member states plus Iceland, Liechtenstein, and Norway.

About ANKTIVA (nogapendekin alfa inbakicept)

ANKTIVA is a first-in-class interleukin-15 (IL-15) receptor agonist (ATC code: L03AC03) consisting of an IL-15 mutant (IL-15N72D) bound to an IL-15 receptor alpha Fc fusion protein. In the European Union, ANKTIVA is available as a 400 µg concentrate for intravesical suspension. ANKTIVA binds with high affinity to IL-15 receptors on natural killer (NK) cells, CD4+ T cells, and CD8+ T cells, activating and expanding these immune effector populations. By activating NK cells, ANKTIVA addresses tumor immune escape mechanisms, while simultaneously restoring memory T cell activity to generate durable antitumor responses. ANKTIVA has improved pharmacokinetic properties, longer persistence in lymphoid tissues, and enhanced antitumor activity compared to native IL-15 in vivo.

IMPORTANT SAFETY INFORMATION

INDICATION AND USAGE: ANKTIVA in combination with Bacillus Calmette-Guérin (BCG) is indicated for the treatment of adult patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumours.

WARNINGS AND PRECAUTIONS: The possibility of severe systemic BCG-infections with the necessity of anti-tuberculosis therapy should be considered before initiating the BCG-therapy.

Delaying cystectomy in patients with BCG-unresponsive NMIBC with CIS, with or without papillary tumours, treated with ANKTIVA therapy in combination with BCG could lead to development of muscle invasive or metastatic bladder cancer.

If patients with CIS that are medically eligible for cystectomy have not achieved a CR (absence of disease or low-grade Ta) to treatment after an induction course of ANKTIVA in combination with BCG at the 12-weeks assessment, cystectomy should be reconsidered as an alternative to re-induction. The risk of developing muscle-invasive or metastatic bladder cancer increases the longer cystectomy is delayed in the presence of persisting CIS.

DOSAGE AND ADMINISTRATION: For intravesical use only. ANKTIVA should NOT be administered by subcutaneous or intravenous or intramuscular use.

From a microbiological point of view, unless the method of opening/reconstitution/dilution precludes the risk of microbial contamination, the product should be used immediately. If not used immediately, in-use storage times and conditions are the responsibility of the user.

ANKTIVA is administered intravesically as a mixture with BCG.

USE IN SPECIFIC POPULATIONS: Pregnancy: Treatment is not recommended during pregnancy and in women of childbearing potential not using effective contraception.

Please see the Summary of Product Characteristics for ANKTIVA available on the European Medicines Agency website at www.ema.europa.eu.

(Press release, ImmunityBio, FEB 19, 2026, View Source [SID1234662784])

Tyra Biosciences to Participate in Upcoming Investor Conferences

On February 19, 2026 Tyra Biosciences, Inc. (Nasdaq: TYRA), a clinical-stage biotechnology company focused on developing next-generation precision medicines that target large opportunities in Fibroblast Growth Factor Receptor (FGFR) biology, reported participation at the following investor conferences:

36th Annual Oppenheimer Life Sciences Healthcare Conference
Format: Virtual fireside chat and one-on-one investor meetings
Presentation Date/Time: Thursday, February 26, 2026 at 12:00pm ET
Location: Virtual

46th Annual TD Cowen Healthcare Conference
Format: Hybrid presentation & fireside chat and one-on-one investor meetings
Presentation Date/Time: Wednesday, March 4th, 2026 at 11:50am ET
Location: Boston, MA

Leerink Global Healthcare Conference
Format: One-on-one investor meetings
Date: March 8-11, 2026
Location: Miami, FL

2026 Jefferies Biotech on the Beach Summit
Format: One-on-one investor meetings
Date: March 9-11, 2026
Location: Miami, FL

Barclays 28th Annual Global Healthcare Conference
Format: One-on-one investor meetings
Date: March 10-12, 2026
Location: Miami, FL

A live webcast of the presentations can be accessed by visiting the "For Investors" page on the Tyra Biosciences website and will be available for replay following the event.

(Press release, Tyra Biosciences, FEB 19, 2026, View Source [SID1234662802])

Insmed Reports Fourth-Quarter and Full-Year 2025 Financial Results and Provides Business Update

On February 19, 2026 Insmed Incorporated (Nasdaq: INSM), a people-first global biopharmaceutical company striving to deliver first- and best-in-class therapies to transform the lives of patients facing serious diseases, reported financial results for the fourth quarter and full year ended December 31, 2025, and provided a business update.

"As we close out 2025 and begin an exciting new year at Insmed, I am energized by the significant opportunities ahead to serve patients with serious diseases," said Will Lewis, Chair and Chief Executive Officer of Insmed. "Our U.S. commercial launch of BRINSUPRI continues to exceed our expectations, and we are proud to provide this medicine to patients who previously had no approved treatment for their disease. Throughout 2026, we will continue to bring BRINSUPRI to patients with bronchiectasis, expand our Phase 3 clinical programs for TPIP, and advance our early-stage pipeline, fueling the research engine that we hope will power the next wave of potentially life-transforming therapies for patients."

Progress and Anticipated Milestones by Therapeutic Area:

Respiratory

BRINSUPRI

•
Insmed anticipates full-year 2026 BRINSUPRI revenues of at least $1 billion.

•
In November 2025, the European Commission approved BRINSUPRI (brensocatib 25 mg tablets) for the treatment of non-cystic fibrosis bronchiectasis (NCFB) in patients 12 years of age and older with two or more exacerbations in the prior 12 months.

•
Insmed anticipates regulatory decisions for brensocatib for the treatment of NCFB in the United Kingdom (UK) and Japan in 2026.

•
Insmed continues to evaluate the potential effect of evolving U.S. policies which will then impact the timing for future potential international commercial launches.

ARIKAYCE

•
Insmed continues to anticipate full-year 2026 ARIKAYCE revenues in the range of $450 million to $470 million.

•
ARIKAYCE global revenue grew 19% in 2025 compared to 2024, reflecting year-over-year growth across all geographic regions and exceeding the upper end of 2025 guidance of $420 to $430 million.

•
In March or April of 2026, the Company anticipates the topline readout of the Phase 3 ENCORE trial in patients with newly diagnosed or recurrent Mycobacterium avium complex (MAC) lung disease who have not started antibiotics.

•
Pending positive topline data from the ENCORE trial, Insmed plans to submit a supplementary new drug application (sNDA) to the U.S. Food and Drug Administration (FDA) for ARIKAYCE in all patients with MAC lung disease in the second half of 2026. Similarly, Insmed plans to review the data with the Pharmaceuticals and Medical Devices Agency (PMDA) in the second half of 2026 to support potential label expansion in Japan.

TPIP

•
In January 2026, the Office of Orphan Products Development of the FDA granted orphan drug designation (ODD) to treprostinil palmitil for the treatment of patients with pulmonary arterial hypertension (PAH). Insmed plans to initiate a Phase 3 study of TPIP (treprostinil palmitil inhalation powder) in patients with PAH in the first half of 2026.

•
Insmed is actively enrolling patients in the PALM-ILD trial, a Phase 3 study of TPIP in patients with pulmonary hypertension associated with interstitial lung disease (PH-ILD).

•
In January 2026, Insmed presented four abstracts from across its TPIP program at the Pulmonary Vascular Research Institute (PVRI) 2026 congress in Dublin.

•
The Company expects to report data from the open-label extension (OLE) of its Phase 2b study of TPIP in PAH in the second half of 2026.

•
The Company anticipates initiating additional Phase 3 studies of TPIP in patients with progressive pulmonary fibrosis (PPF) and idiopathic pulmonary fibrosis (IPF) in the second half of 2026.

INS1148

•
In December 2025, Insmed acquired INS1148, a Phase 2-ready monoclonal antibody targeting a specific isoform of Stem Cell Factor, called Stem Cell Factor 248 (SCF248).

•
The Company plans to advance Phase 2 development programs for INS1148 initially in interstitial lung disease (ILD) and moderate to severe asthma.

Immunology & Inflammation

Brensocatib

•
In October 2025, Insmed completed enrollment in the Phase 2b CEDAR study of brensocatib in patients with hidradenitis suppurativa (HS). Insmed anticipates reporting topline data from CEDAR in the second quarter of 2026.

INS1033

•
Insmed’s second dipeptidyl peptidase 1 (DPP1) inhibitor, INS1033, is currently advancing toward the clinic in rheumatoid arthritis (RA) and inflammatory bowel disease (IBD), with an initial IND filing expected in 2026.

Neuro & Other Rare

INS1201

•
Insmed continues to enroll the Phase 1 ASCEND clinical study of INS1201, an intrathecally delivered gene therapy for patients with Duchenne muscular dystrophy (DMD).

INS1202

•
In January 2026, the Company dosed the first patient in the Phase 1 ARMOR study of INS1202, an intrathecally delivered gene therapy for patients with amyotrophic lateral sclerosis (ALS).

INS1203

•
Insmed’s third gene therapy candidate, INS1203, targeting Stargardt disease, is currently advancing toward the clinic, with an IND filing expected in 2026.

3
Fourth-Quarter and Full-Year 2025 Financial Results

The following table summarizes fourth-quarter and full-year 2025 and 2024 revenues and revenue growth for BRINSUPRI and ARIKAYCE across all commercial regions:

Three Months Ended

Twelve Months Ended

December 31,

December 31,

(in millions)

2025

2024

Growth

2025

2024

Growth

ARIKAYCE

U.S.

$
73.4

$
67.8

8
%

$
280.3

$
254.8

10
%
International

45.9

36.7

25
%

153.5

108.9

41
%
Total

$
119.2

$
104.4

14
%

$
433.8

$
363.7

19
%
BRINSUPRI

U.S.

$
144.6

$
–

N/A

$
172.7

$
–

N/A

International

–

–

N/A

–

–

N/A

Total

$
144.6

$
–

N/A

$
172.7

$
–

N/A

Total Revenues

U.S.

$
218.0

$
67.8

222
%

$
453.0

$
254.8

78
%
International

45.9

36.7

25
%

153.5

108.9

41
%
Total

$
263.8

$
104.4

153
%

$
606.4

$
363.7

67
%

•
Cost of product revenues (excluding amortization of intangibles) was $44.2 million for the fourth quarter of 2025, compared to $26.2 million for the fourth quarter of 2024. For full-year 2025, cost of product revenues (excluding amortization of intangibles) was $122.9 million compared to $85.7 million for full-year 2024. The increase in cost of product revenues in the fourth quarter of 2025 and full-year 2025 primarily reflects the increase in total product revenues for ARIKAYCE and BRINSUPRI, following BRINSUPRI’s U.S. commercial launch in August 2025. Cost of product revenues as a percentage of revenues decreased in the fourth quarter of 2025 and full-year 2025 due to sales of BRINSUPRI, which has a lower manufacturing cost than ARIKAYCE.

•
Research and development (R&D) expenses were $254.9 million for the fourth quarter of 2025, compared to $179.7 million for the fourth quarter of 2024. For full-year 2025, R&D expenses were $771.1 million compared to $598.4 million for full-year 2024. The increase in R&D expenses for fourth quarter of 2025 and full-year 2025 was primarily related to increases in compensation and benefit-related expenses, as well as stock-based compensation, increases in manufacturing expense, and the acquisition of INS1148.

•
Selling, general and administrative (SG&A) expenses for the fourth quarter of 2025 were $212.5 million, compared to $142.5 million for the fourth quarter of 2024. For full-year 2025, SG&A expenses were $701.2 million, compared to $461.1 million for full-year 2024. The increase in SG&A expenses for the fourth quarter of 2025 and full-year 2025 was primarily related to increases in compensation and benefit-related expenses, as well as stock-based compensation, and an increase in professional fees and other external expenses, both driven by commercial and commercial readiness activities for BRINSUPRI.

•
For the fourth quarter of 2025, Insmed reported a net loss of $328.5 million, or $1.54 per share, compared to a net loss of $235.5 million, or $1.32 per share, for the fourth quarter of 2024. For full-year 2025, Insmed reported a net loss of $1,276.8 million, or $6.42 per share, compared to a net loss of $913.8 million, or $5.57 per share, for full-year 2024.

Balance Sheet, Financial Guidance, and Planned Investments

•
As of December 31, 2025, Insmed had cash, cash equivalents, and marketable securities totaling approximately $1.4 billion.

•
The Company anticipates full-year 2026 BRINSUPRI revenues of at least $1 billion.

•
Insmed continues to anticipate full-year 2026 ARIKAYCE revenues in the range of $450 million to $470 million.

•
The Company anticipates submitting an average of one to two INDs per year from its pre-clinical research programs.

•
Insmed continues to anticipate that the totality of its pre-clinical research programs will comprise less than 20% of overall expenditures.

•
The Company plans to continue to invest in the following key activities in 2026:

(i)
commercialization and expansion of BRINSUPRI and ARIKAYCE;

(ii)
preparation of regulatory submissions for full approval for ARIKAYCE in the U.S. and label expansion to include all patients with a MAC lung infection in the U.S. and Japan, pending positive topline results from the Phase 3 ENCORE trial;

(iii)
advancement of the clinical development programs for TPIP, including the Phase 3 studies in patients with PH-ILD, PAH, PPF, and IPF;

(iv)
advancement of clinical development programs for INS1148 in ILD and moderate to severe asthma;

(v)
advancement of the clinical trial programs for INS1201 in DMD and INS1202 in ALS, as well as IND-enabling activities for INS1203 in Stargardt disease;

(vi)
advancement of IND-enabling activities for INS1033 in RA and IBD; and

(vii)
continued development of its pre-clinical research programs.

Conference Call

Insmed will host a conference call beginning today, February 19, 2026, at 8:00 AM Eastern Time. Shareholders and other interested parties may participate in the conference call by dialing (888) 210-2654 (U.S. and international) and referencing access code 7862189. The call will also be webcast live on the Company’s website at www.insmed.com.

A replay of the conference call will be accessible approximately 1 hour after its completion through February 26, 2026, by dialing (800) 770-2030 (U.S. and international) and referencing access code 7862189. A webcast of the call will also be archived for 90 days under the Investor Relations section of the Company’s website at www.insmed.com.

(Press release, Insmed, FEB 19, 2026, View Source [SID1234662785])

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Category: Uncategorized

10x Genomics to Participate in the 46th Annual TD Cowen Health Care Conference

Entry into a Material Definitive Agreement

ImmunityBio Expands Access to ANKTIVA® in EU with New Distribution Partnership and Opens Irish Subsidiary to Support European Launch

Tyra Biosciences to Participate in Upcoming Investor Conferences

Insmed Reports Fourth-Quarter and Full-Year 2025 Financial Results and Provides Business Update