On February 13, 2026 Precision Biologics, Inc. CEO Philip M. Arlen, MD reported a Keynote presentation describing in vitro and in vivo efficacy of its novel tumor-specific antibody-drug-conjugate PB-223 ADC (PB-vcMMAE-5). Recent tumor killing data showing specific non-toxic anti-tumor activity in several human cancer types expressing truncated core 2 O-glycans will be reported in "PB-223, A Novel Antibody Drug Conjugate Targeting Truncated Core-2 glycans in Solid Tumors", at the 6th Ace Drug Discovery Summit, The Insurance Hall, London, UK, February 18-19, 2026.

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"The exquisite sensitivity and specificity of our recently developed mAb enables maximum anti-tumor response to our PB-223 ADC with minimal toxicity in the preclinical animal studies. The target is found on a broad variety of human solid tumors but not on healthy tissue, suggesting a strong rationale to move this drug into clinical trials."

"We’re excited to discuss PB-223 ADC with the scientific community, to share compelling preclinical data with several human tumor types, showing animal xenograph human tumor models resulting in complete tumor eradication with minimal toxicity observed in blood and tissue analysis," he went on to say. Although some preliminary data was shown on posters at SITC (Free SITC Whitepaper) (Society for the Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)) and AACR (Free AACR Whitepaper)-Ovarian (American Association for Cancer Research, Ovarian Cancer) meetings, this is the first public talk presenting and explaining the full data in person.

Here are details of the presentation:

Title:

"PB-223, A Novel Antibody Drug Conjugate Targeting Truncated Core-2 glycans in Solid Tumors"

Date/Time:

Thursday, February 19, 12:00pm – 12:30pm – Day 2 – Presentation no. 15

Place:

6th ACE Drug Discovery Summit, The Insurance Hall, 20-21 Aldermanbury, London, UK

Keynote Speaker:

Philip Arlen, President & CEO, Precision Biologics, Inc.

(Press release, Precision Biologics, FEB 13, 2026, View Source [SID1234662676])

On February 13, 2026 Nektar Therapeutics (Nasdaq: NKTR), a clinical-stage biotechnology company focused on the development of innovative medicines in the field of immunotherapy, reported the closing of its underwritten public offering of $460 million of shares of its common stock and, in lieu of common stock to certain investors, pre-funded warrants. Nektar sold 7,637,931 shares of common stock in the offering, which includes 1,034,482 shares sold upon exercise in full by the underwriters of their option to purchase additional shares of common stock in the offering, and 293,103 pre-funded warrants. The shares of common stock were sold at a public offering price of $58.00 per share and the pre-funded warrants to purchase shares of common stock were sold at a public offering price of $57.9999 per pre-funded warrant, which represents the per share public offering price of each share of common stock less the $0.0001 per share exercise price of each pre-funded warrant. The gross proceeds to Nektar from the offering were approximately $460 million, before deducting underwriting discounts and commissions and estimated offering expenses. All of the securities sold in this offering were offered by Nektar.

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Jefferies, TD Cowen, and Piper Sandler acted as joint bookrunning managers for the offering. Oppenheimer & Co. and H.C. Wainwright & Co. acted as lead managers and B. Riley Securities acted as manager for the offering.

The securities described above were offered pursuant to a shelf registration statement on Form S-3ASR (No. 333-291466) that was filed with the U.S. Securities and Exchange Commission (the "SEC") on November 12, 2025 and automatically became effective upon filing. This offering was made only by means of a prospectus supplement and an accompanying prospectus that form a part of the registration statement.

A final prospectus supplement related to and describing the terms of the offering was filed with the SEC and is available on the SEC’s website located at www.sec.gov. Copies of the final prospectus supplement and an accompanying prospectus related to the offering may also be obtained from Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, New York, NY 10022, by telephone at (877) 821-7388, or by email at [email protected]; TD Securities (USA) LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717 or by email at [email protected]; or Piper Sandler & Co., 350 North 5th Street, Suite 1000, Minneapolis, MN 55401, Attention: Prospectus Department, by telephone at (800) 747-3924, or by email at [email protected].

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

(Press release, Nektar Therapeutics, FEB 13, 2026, View Source [SID1234662675])

On February 13, 2026 Beyond Air, Inc. (NASDAQ: XAIR) ("Beyond Air" or the "Company"), a commercial stage medical device and biopharmaceutical company focused on harnessing the power of nitric oxide (NO) to improve the lives of patients, reported its financial results for the fiscal third quarter ended December 31, 2025, and provided a corporate update.

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"We exceeded $2.0 million in quarterly revenue which marks an important milestone as we continue scaling our business and building awareness of the benefits our tankless NO system delivers in real-world settings," said Steve Lisi, Chief Executive Officer of Beyond Air. "Our commercial performance reflects steady momentum, with 21% sequential quarterly growth and a 105% increase over the same quarter last year. We will continue to grow our business with LungFit PH as we prepare for the FDA clearance of our second-generation LungFit PH system, which we expect to receive before the end of calendar 2026, subject to regulatory review. We believe the significant enhancements, including reduced weight and footprint, simplified operation, longer service interval, and full compatibility with both air and ground transport, will dramatically accelerate market share gains and position Beyond Air as a global leader in hospital-based NO delivery."

"We are excited that an abstract featuring Phase 1a data from Beyond Cancer’s UNO program in solid tumors was selected to be presented at the AACR (Free AACR Whitepaper) 2026 Annual Meeting in April. The team will present the latest exciting clinical data from this important trial," concluded Mr. Lisi.

The Company had a pro forma cash balance of approximately $22.3 million, which includes cash, cash equivalents, restricted cash and marketable securities of $17.8 million as of December 31, 2025, plus net proceeds of approximately $4.5 million from the Company’s previously announced private placement that closed on January 14, 2026, and assumes no other changes to cash, cash equivalents, restricted cash and marketable securities since December 31, 2025.

Commercial Execution, Recent Highlights and Upcoming Milestones

LungFit PH Commercial Execution
Revenue increased 105% to $2.2 million for the fiscal quarter ended December 31, 2025, compared to $1.1 million for the same period last year. Growth was driven by increased demand for LungFit PH in both the U.S. and international markets.
The Company completed its first sale of LungFit PH systems to a VA Medical Center during the fiscal third quarter of 2026, creating a potential pathway for future orders and broader adoption across the VA system. Engagement with VA centers provides access to the largest healthcare network in the U.S.
Expanded Global LungFit PH distribution network, including new agreements in Canada, Germany, Brazil, Austria, the Netherlands and Sri Lanka, bringing the total international coverage to 40 countries, representing a combined population of more than three billion people, nine times greater than the United States population.
Corporate Highlights
Appointed Dan Moorhead as Chief Financial Officer, effective January 5, 2026. Mr. Moorhead brings more than 20 years of finance leadership experience across both public and private companies.
Announced that Board member Bob Carey will assume the role of Chairman of the Board, reflecting the Board’s continued focus on strengthening governance and supporting the Company’s next phase of commercial and strategic growth. Mr. Carey’s experience and leadership are expected to provide valuable guidance as Beyond Air advances its regulatory, commercial, and strategic initiatives. Mr. Lisi will remain on the Board of Directors.
Strengthened the balance sheet with approximately $4.5 million in net proceeds from the private placement announced on January 14, 2026.
Pending Regulatory Milestones
Awaiting approval of the PMA supplement for the second-generation LungFit PH, which was submitted to U.S. FDA in June 2025.
International submissions for LungFit PH remain on track with local partners.
Beyond Cancer – Solid Tumor Program – clinical stage development of an intratumoral ultra-high concentration Nitric Oxide (UNO) technology as a gas delivery of NO at high concentrations to tumors to induce an immune response.

Clinical Development Execution
Phase 1a trial (monotherapy) – Part A of the trial evaluating UNO therapy in 10 subjects with advanced, relapsed or refractory unresectable, primary or metastatic cutaneous and subcutaneous solid tumors at a dose of 25,000 ppm has been completed.
An abstract featuring data from the study was selected for presentation at the 2026 AACR (Free AACR Whitepaper) Annual Meeting, which is taking place April 17-22, in San Diego, California.
Phase 1b trial (combination therapy) – Will assess the intratumoral administration of 25,000 ppm low volume (LV) Nitric Oxide (UNO) in subjects with unresectable cutaneous or subcutaneous histologically confirmed primary or metastatic lesions, who have shown disease progression or prolonged stable disease (12 weeks) after receiving a single agent anti-PD-1 containing treatment.
NeuroNOS – On January 13, 2026, XTL Biopharmaceuticals Ltd. announced a binding agreement to acquire 85% of NeuroNOS Ltd. for consideration, under which Beyond Air, for its approximately 85% ownership, will receive 19.9% of XTL’s issued share capital, $1.0 million in cash, and milestone-based contingent payments totaling up to $31.5 million.

Upon closing of the agreement, NeuroNOS will serve as XTL’s flagship platform for autism and neuro-oncology therapeutics.

Financial Results for the Fiscal Quarter Ended December 31, 2025

Revenues for the fiscal quarter ended December 31, 2025 increased 105% to $2.2 million, compared with $1.1 million for the fiscal quarter ended December 31, 2024. Gross profit increased to $0.3 million for the quarter ended December 31, 2025, compared with a gross loss of $0.2 million for the quarter ended December 31, 2024. The increase in gross profit was primarily attributed to sales growth.

Research and development expenses for the fiscal quarter ended December 31, 2025 decreased 19% to $2.4 million compared with $3.0 million for the fiscal quarter ended December 31, 2024.

Selling, general and administrative expenses for the quarters ended December 31, 2025 and 2024 were $4.5 million and $7.7 million, respectively. The decrease of 42% or $3.2 million was primarily attributed to a reduction in employee-related costs.

Other expense for the quarter ended December 31, 2025 was $1.0 million compared with other expense of $2.4 million for the quarter ended December 31, 2024. The decrease in expense of $1.4 million was primarily attributed to the prior period loss associated with the extinguishment of debt.

Net loss attributed to common stockholders of Beyond Air, Inc. for the quarter ended December 31, 2025 was ($7.3) million or a loss of ($0.85) per share, basic and diluted, compared to a net loss attributed to common stockholders of Beyond Air, Inc. for the fiscal quarter ended December 31, 2024 of ($13.0) million or a loss of ($2.96) per share, basic and diluted.

Net cash burn, excluding inflows from financing activities, in the fiscal quarter ended December 31, 2025 was $4.3 million.

As of December 31, 2025, the Company reported cash, cash equivalents, restricted cash and marketable securities of $17.8 million. Subsequent to the end of the fiscal third quarter, the Company completed a private placement for net proceeds of $4.5 million. The Company believes this provides a cash runway into calendar year 2027.

Total long-term debt outstanding was $22.0 million as of December 31, 2025. The Company has $18.8 million remaining through an equity line of credit. The $12 million promissory note announced in November 2025 bears a 15% interest rate and matures 24 months from the issuance date, with no payments due during the first 12 months.

(Press release, Beyond Air, FEB 13, 2026, View Source [SID1234662674])

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

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

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

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

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

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

Commercial Updates

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

Fourth Quarter 2025 Financial Results

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

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

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

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

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

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

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

Full Year 2025 Financial Results

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

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

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

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

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

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

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

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

2026 Financial Framework

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

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

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

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

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

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

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

Recent Progress and Upcoming Late-Stage Pipeline Milestones

Infectious disease vaccines:

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

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

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

Oncology therapeutics:

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

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

Rare disease therapeutics:

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

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

Moderna Corporate Updates

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

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

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

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

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

Company Accolades

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

Key 2026 Investor and Analyst Event Dates

Analyst Day: November 12

Investor Call and Webcast Information

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

Telephone: View Source

Webcast: View Source

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

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