On November 11, 2026 Novavax, Inc. (Nasdaq: NVAX) reported that company management will participate in the following upcoming investor conference:

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Jefferies London Healthcare Conference, London, United Kingdom
Fireside chat on Tuesday, November 17, 2026, at 5:00 p.m. GMT

A live webcast of the fireside chat will be available on the "Events & Presentations" page of the Company’s website at ir.novavax.com. A replay of each webcast will be available for 30 days following the presentation.

(Press release, Novavax, NOV 11, 2026, View Source [SID1234674614])

On November 11, 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 patients’ lives, reported financial results for the quarter ended September 30, 2026, and provided a corporate update.

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"Building on the commercial momentum we are generating with our first-generation LungFit PH system, we believe our second-generation system has the potential to substantially expand our market opportunity and accelerate growth, pending FDA approval," said Robert Goodman, Chief Executive Officer of Beyond Air. "Our US pipeline is now experiencing unprecedented expansion with an acceleration in demand for our first-generation system and high receptivity to our technology and its operational efficiencies, creating a natural demand for our next generation product. We are especially pleased with the pace of new account wins and rate of renewals, which speak to the high level of customer satisfaction with our unique technology – all of which we believe we can leverage into the potential future launch of our second-generation LungFit PH system. Subject to FDA approval, the system is designed to provide a smaller footprint, reduced weight, simplified operation, longer service intervals and expanded operational flexibility. The PMA supplement seeks expanded FDA labeling that would permit use during patient transport by air and ground."

Mr. Goodman continued, "We remain encouraged by our active and productive discussions with the FDA and the progress we are making toward completing the remaining steps in the review process for the second-generation LungFit PH system. We expect to complete our audit-readiness process in mid-December, and subject to FDA inspections and final approval thereafter."

Recent Financial and Operating Highlights

Reported revenue of $2.3 million for the quarter ended September 30, 2026, the highest quarterly revenue in the Company’s history, representing approximately 28% growth over the same period last year and 31% growth compared with the quarter ended June 30, 2026.
Executed the Company’s enhanced commercial strategy for first-generation LungFit PH, supporting increased adoption of its cylinder-free nitric oxide technology.
Advanced preparations for the potential U.S. commercial launch of the second-generation LungFit PH system, subject to FDA approval. If approved, the Company believes the addition of transport capability would enable Beyond Air to serve as a single-source nitric oxide provider for hospitals and health systems.
Received FDA Breakthrough Device Designation for LungFit GO for the treatment of nontuberculous mycobacterial pulmonary disease (NTM-PD). The Company does not plan to allocate resources to further development of LungFit GO until the commercial launch of second-generation LungFit PH is well established, following FDA approval.
Announced a definitive agreement under which UNIVO Pharmaceutical Industries Ltd. would acquire the Company’s controlling interest in NeuroNOS Israel Ltd. The transaction is intended to provide NeuroNOS with dedicated resources, funding and strategic focus to advance its development programs.
Evaluating potential development partnerships and other strategic arrangements to support the continued advancement of Beyond Cancer’s pipeline, while maintaining Beyond Air’s focus and resource allocation on its commercialization of LungFit PH.
Pending Regulatory Milestones

The PMA supplement for the second-generation LungFit PH system, submitted in June 2025, remains under FDA review.
Financial Results for the Quarter Ended September 30, 2026

Revenue for the quarter ended September 30, 2026 was $2.3 million, compared with $1.8 million for the same period last year.

Research and development expenses for the three months ended September 30, 2026 were $1.6 million as compared to $2.5 million for the three months ended September 30, 2025. The decrease was primarily attributed to lower costs related to the second-generation LungFit PH as the majority of development is complete.

Selling, general and administrative expenses for the three months ended September 30, 2026 were $4.6 million as compared to $4.9 million for the three months ended September 30, 2025. The decrease was attributed primarily to decreases in stock-based compensation costs, partially offset by increased salaries in our sales organization as we build out our commercial team.

Other expense for the three months ended September 30, 2026 was $2.2 million as compared to other expense of $0.6 million for the three months ended September 30, 2025. The increase in expense was attributed primarily to an increase in the Company’s outstanding debt and related interest expense, in addition to a charge for scrapped materials.

Net loss attributed to common stockholders of Beyond Air, Inc. for the three months ended September 30, 2026 was $7.8 million, or a loss of $3.76 per basic and diluted share, compared with a net loss of $7.9 million, or a loss of $24.98 per basic and diluted share, for the three months ended September 30, 2025.

As of September 30, 2026, the Company reported cash, cash equivalents, restricted cash and marketable securities of $18.5 million, including $2.7 million of cash held by NeuroNos which is included within current assets held for sale on the balance sheet and $0.7 million of cash held by Beyond Cancer. Restricted cash at September 30, 2026 was $4.8 million.

Financial Guidance

The Company reaffirms its previously issued revenue guidance of $8 million for calendar year 2026, which excludes revenue from the second-generation LungFit PH system. The Company also reaffirms its revenue guidance of $16 million to $18 million for calendar year 2027, which includes anticipated revenue from the second-generation system, pending FDA approval.

Conference Call and Webcast

Wednesday, November 11, 2026 at 4:30 p.m. ET

Domestic: 1-877-407-0784

International: 1-201-689-8560

Conference ID: 13763626

Webcast: A webcast of the live conference call can be accessed by visiting the Events section of the Company’s website (click here) or directly (click here). An online replay will be available on the Company’s website or via the direct link an hour after the call.

As previously announced, and formally approved by the Board of Directors, the Company is transitioning its fiscal year end from March 31 to December 31, effective December 31, 2026. As a result, the Company expects to report financial results for the nine-month transition period ending December 31, 2026 on a Form 10-K/T.

(Press release, Beyond Air, NOV 11, 2026, View Source;beyond-air-reports-financial-results-and-provides-corporate-update-for-the-quarter-ended-september-30-2026 [SID1234674613])

On November 11, 2026 enGene Therapeutics Inc. (Nasdaq: ENGN, "enGene" or the "Company"), a clinical-stage, non-viral genetic medicines company, reported updated results from the pivotal Cohort 1 of its ongoing, Phase 2 LEGEND trial of detalimogene voraplasmid (also known as detalimogene). Data from Cohort 1, which enrolled 125 patients with high-risk, Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without concomitant papillary disease, are expected to form the basis for a Biologics License Application (BLA) with the U.S. Food and Drug Administration (FDA).

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"For patients with high-risk BCG-unresponsive NMIBC, we need therapies that provide meaningful and durable disease control while minimizing treatment-related toxicity and burden," said Ashish M. Kamat, MD, Professor of Urologic Oncology at The University of Texas MD Anderson Cancer Center and Primary Investigator of the LEGEND trial. "The updated LEGEND data are encouraging, demonstrating clinically meaningful antitumor activity with a favorable tolerability profile. Combined with its straightforward administration and handling requirements, detalimogene has the potential to become a valuable addition to our bladder-preserving treatment options, particularly in community urology practices where ease of administration and practical considerations can influence treatment selection."

"The updated results from Cohort 1 demonstrate encouraging improvements across all key efficacy measures as the data have matured, bringing detalimogene’s efficacy profile to date within range of approved products for this indication," said Ron Cooper, President and Chief Executive Officer, enGene. "Importantly, our recent interactions with the FDA provide a clear path to initiate a BLA submission before year-end 2026, representing a significant step toward bringing detalimogene to patients, with potential approval in 2027."

Mr. Cooper continued, "In parallel, we are preparing for commercialization, with a focus on positioning detalimogene for broad adoption across community urology practices, where more than 75% of high-risk, BCG-unresponsive NMIBC patients receive care. We believe detalimogene’s differentiated ease of use and handling could facilitate integration into existing treatment settings, helping expand access to a new bladder-preserving treatment option for patients."

LEGEND Pivotal Cohort Update

The following efficacy data are based on 120 efficacy-evaluable patients enrolled in Cohort 1 as of the data cutoff date, October 29, 2026.

Efficacy Overview:

CR at any time of 56% (CI:47%, 65%) (n=120)
Landmark 12-month CR rate is 24% (CI: 16%, 33%) (n=110)
1 patient is pending the 12-month landmark disease assessment
Median follow-up for responders increased to 12.0 months from 9.2 months since April 2026 data analysis
Preliminary Kaplan-Meier Estimate of DoR ≥12 months is 43% (CI: 30%, 55%)
9 patients are pending the DoR ≥12 months disease assessment
8 patients currently in maintenance are pending a durability assessment
1 patient is pending the 12-month landmark disease assessment
100% of patients who entered maintenance and had been assessed for durability have recorded durable responses
Median duration of complete response is 10.1 months (CI: 7.5, Not Estimable)
97% of all efficacy evaluable patients were free from progression to muscle-invasive or metastatic bladder cancer, defined as T2 or greater disease
100% of responders were free from progression to T2 or greater disease in the bladder
86% of all efficacy evaluable patients remain free from cystectomy
96% of responders remain free from cystectomy
Safety Overview:

The overall tolerability profile associated with detalimogene has been favorable. Of the 125 patients assessed for safety in Cohort 1, 59% experienced at least one TRAE, which were mainly Grade 1/2 in severity. The most common TRAEs were fatigue (21%), dysuria (16%), pollakiuria (16%), and bladder spasm (13%), micturition urgency (13%), and urinary tract infection (10%). Only 4% of patients experienced Grade 3 TRAE, with just 2% of patients experiencing a serious TRAE. No Grade 4 or Grade 5 TRAEs were reported. TRAEs leading to dose discontinuation (1%) or dose interruption (4%) were rare.

Regulatory Update and Anticipated Milestones:

Following the Company’s pre-BLA meeting with the FDA, enGene reached alignment on key components of the planned BLA for detalimogene, including the efficacy evaluable patient population. The Company expects to initiate the submission by year-end 2026 and plans to complete the BLA submission in the first half of 2027, with potential FDA approval in 2027. In addition, the Company expects to provide an update on the detalimogene plus surfactant bladder rinse cohort mid- 2027.

Conference Call and Webcast

enGene will host a conference call and webcast on November 11, 2026, at 4:30 p.m. Eastern Time to discuss the updated LEGEND data and provide an overview of the regulatory path for detalimogene. Details for the conference call and webcast are included below.

Conference Call Dial-in Numbers:

North America Toll-Free: +1 833-461-5787
International Toll: +1 585-542-9983
Additional International Dial-Ins can be found here

Meeting ID: 485 327 198

Webcast Link: View Source

A link to the webcast will also be available on the Investors section of enGene’s website. A replay of the webcast will be available at this same link within two hours of the event’s conclusion.

About Non-Muscle Invasive Bladder Cancer (NMIBC)

Non-muscle invasive bladder cancer (NMIBC) is a disease that poses a significant burden on both patients and clinics and has a massive economic impact on the healthcare system. NMIBC occurs when cancer cells grow in the tissues that line the interior of the bladder, but the cancer has not yet penetrated the muscle of the bladder wall. NMIBC can present as papillary outgrowths from the bladder wall, which are typically resected, or as carcinoma in situ (CIS), which consists of flat, multifocal lesions that cannot generally be resected. The two forms can also co-occur. About 75%-80% of new bladder cancer diagnoses are NMIBC. Patients suffering from high-risk NMIBC who are unresponsive to the standard of care, Bacillus Calmette-Guérin (BCG), face high rates of disease recurrence (50%-70%) and are potentially subject to full removal of the bladder (cystectomy) as a curative but life-altering next step.

About Detalimogene Voraplasmid

Detalimogene is a novel, investigational, non-viral gene therapy for patients with high-risk, non-muscle invasive bladder cancer (NMIBC), including Bacillus Calmette-Guérin (BCG)-unresponsive disease. It is designed to be instilled in the bladder and elicit a powerful yet localized anti-tumor immune response.

Detalimogene was developed using the Company’s Dually Derivatized Oligochitosan (DDX) platform, a technology designed to transform how gene therapies are accessed by patients and utilized by clinicians. Medicines developed with the DDX platform can potentially overcome the limitations of viral-based gene therapies, reduce complexities related to safe handling and cold storage, and streamline both manufacturing processes and administration paradigms.

Regenerative Medicine Advanced Therapy (RMAT) and Fast Track Designations

Detalimogene has received Regenerative Medicine Advanced Therapy (RMAT) and Fast Track designations from the U.S. Food and Drug Administration (FDA) based on its potential to address the high unmet medical need for patients with BCG-unresponsive carcinoma in situ (CIS) NMIBC with or without resected papillary tumors who are unable or refuse to undergo cystectomy. These designations are intended to expedite the development and review of drugs intended to treat serious or life-threatening conditions and fill an unmet medical need. Detalimogene has also been selected for the FDA’s Chemistry, Manufacturing, and Controls (CMC) Development and Readiness Pilot (CDRP) program, designed to facilitate CMC development for therapies with compressed clinical development timeframes based on the anticipated clinical benefits of earlier patient access to the therapy.

About the LEGEND Trial

Detalimogene is being evaluated in the ongoing, open-label, multi-cohort, Phase 2 LEGEND trial to establish its safety and efficacy in high-risk NMIBC. LEGEND’s pivotal cohort (Cohort 1) consists of 125 patients with high-risk, BCG-unresponsive NMIBC with CIS (with or without papillary disease) and is designed to serve as the basis of the Company’s planned Biologics License Application (BLA) filing. In addition to this pivotal cohort, LEGEND includes four additional cohorts, including NMIBC patients with CIS who are naïve to treatment with BCG (Cohort 2a); NMIBC patients with CIS who have been exposed to BCG but have not received adequate BCG treatment (Cohort 2b); BCG-unresponsive high-risk NMIBC patients with papillary-only disease (Cohort 3); and BCG-unresponsive high-risk NMIBC patients with CIS who receive polidocanol plus detalimogene.

(Press release, enGene Therapeutics, NOV 11, 2026, View Source [SID1234674612])

On November 11, 2026 Aptevo Therapeutics Inc. (NASDAQ:APVO) ("Aptevo" or the "Company"), a clinical-stage biotechnology company developing novel multispecific immuno-oncology therapeutics, reported that the Company has entered into warrant inducement letter agreements with certain holders of its existing common warrants (the "Existing Warrants"), pursuant to which such holders have agreed to exercise in full for cash their Existing Warrants to purchase up to an aggregate of 2,777,778 shares of common stock of the Company ("common stock") at a reduced exercise price of $1.08 per share. In consideration for such cash exercises, the Company will issue new unregistered common stock purchase warrants (the "Inducement Warrants") to purchase up to an aggregate of 13,888,890 shares of common stock at an exercise price of $1.08 per share. The Inducement Warrants will be exercisable on or after the date on which the Company obtains the required stockholder approval and will expire five years after their initial exercise date. The shares of common stock issuable upon exercise of the Existing Warrants are registered pursuant to effective registration statements on Form S-1 (File No. 333-298483).

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The aggregate gross proceeds from the transaction described herein are expected to total approximately $3.0 million, before deducting placement agent fees and expenses.

Roth Capital Partners is acting as the Company’s financial advisor in connection with this transaction.

The transaction is expected to close on or about November 12, 2026, subject to satisfaction of customary closing conditions. The Company intends to use the net proceeds from the transaction for working capital purposes.

The Inducement Warrants described above were offered in a private placement pursuant to an applicable exemption from the registration requirements of the Securities Act of 1933 (the "Securities Act"). The Inducement Warrants, along with the common stock issuable upon their exercise, have not been registered under the Securities Act, and may not be offered or sold in the United States absent registration with the Securities and Exchange Commission ("SEC") or an applicable exemption from such registration requirements. The Company has agreed to file a registration statement with the SEC covering the resale of common stock issuable upon exercise of the New Warrants.

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 the registration or exemption under the securities laws of any such state or jurisdiction.

(Press release, Aptevo Therapeutics, NOV 11, 2026, View Source [SID1234674611])

On November 11, 2026 Tempest Therapeutics, Inc. (Nasdaq: TPST) ("Tempest"), a clinical-stage biotechnology company developing in vivo CAR-T therapies designed to reset dysfunctional immunity in cancer and autoimmune disease, reported that it has exercised its option under its agreement with Hebei Senlang Biotechnology Co., Ltd. ("Senlang") to obtain an exclusive license to develop and commercialize Senlang’s CD7-targeted lentiviral vector platform and associated in vivo CAR-T candidates worldwide, excluding China.

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The CD7-targeted lentiviral platform is designed to deliver CAR payloads into the patient’s own immune cells, complementing Tempest’s existing lipid nanoparticle (LNP) delivery platform, for the in vivo generation of antigen-directed CAR-T cells. The lead program is SL4903, which Tempest is designating TPST-4903, a BCMA/GPRC5D dual-targeting candidate being studied in relapsed or refractory multiple myeloma (rrMM). By targeting two clinically validated targets in rrMM, TPST-4903 may reach a broader range of malignant plasma cells and limit tumor escape resulting from the loss or reduced expression of either target. The license also provides access to additional in vivo CAR-T candidates for potential development in blood cancers, solid tumors, and autoimmune conditions.

"Our decision to exercise this option and obtain an exclusive license reflects our confidence in the platform and the differentiating clinical observations from the lead program," said Matt Angel, Ph.D., President and Chief Executive Officer of Tempest. "We are encouraged by the emerging clinical data from the ongoing DELIVER-1 Phase 1 dose-escalation study of TPST-4903, which includes multiple myeloma patients with a substantial unmet need for new treatment options, such as those with extramedullary disease and those previously treated with CAR-T therapy. We look forward to sharing the detailed results with the scientific community."

At the data cutoff for the current analysis, 13 patients in the DELIVER-1 study had received TPST-4903. The study population includes heavily pretreated patients with rrMM, including patients with extramedullary disease (EMD) and patients who previously received a BCMA-targeted CAR-T therapy. Tempest believes that preliminary observations of clinical activity and tolerability are encouraging and support further evaluation. The findings remain early, and additional follow-up is needed to characterize the benefit-risk profile. The data are expected to be presented at a major scientific conference.

"With the addition of this clinical-stage lentiviral platform alongside our targeted LNP platform, we have expanded our capabilities to develop in vivo immune reset therapies for cancer and autoimmune disease," said Dr. Angel. "We continue to believe that these complementary platforms provide Tempest with the flexibility to match the delivery approach to the biology and treatment requirements of different cancers and autoimmune diseases."

Tempest originally announced the exclusive option agreement with Senlang in September 2026. The license is subject to the financial obligations and development requirements set out in that agreement.

About TPST-4903, DELIVER-1, and Tempest’s CD7-Directed Lentiviral Platform

TPST-4903 is an investigational in vivo CAR-T therapy targeting BCMA and GPRC5D and delivered using a CD7-targeted lentiviral vector. DELIVER-1 (NCT07586709) is a single-center, open-label Phase 1 dose-escalation study enrolling patients with rrMM who have received at least two prior lines of therapy. The study is evaluating safety, tolerability, preliminary antimyeloma activity, and pharmacokinetic and pharmacodynamic characteristics. Tempest’s CD7-directed lentiviral platform, exclusively licensed from Senlang, includes a pipeline of clinical and preclinical-stage in vivo CAR-T programs, which are designed to selectively deliver CAR payloads to endogenous CD7-positive T cells and NK cells, enabling in vivo generation of antigen-directed CAR immune cells.

(Press release, Tempest Therapeutics, NOV 11, 2026, View Source [SID1234674610])