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Virax Biolabs (NASDAQ: VRAX) reported clinical and operational progress and outlined 2026 priorities focused on its ViraxImmune™ T cell diagnostic programme for post-acute infection syndromes (PAIS).
Key facts: full recruitment completed in UK study VRX-002 (160 participants) with initial data expected in Q2 2026; second UK study VRX-003 fully enrolled (100 subjects); U.S. research collaboration with Emory University to support a planned U.S. study; ongoing expansion of the ImmuneSelect RUO product portfolio for near-term research revenue; and a debt-free balance sheet with $3.3M cash, total assets of $5.7M, liabilities of $0.6M and market capitalization of ~$1.7M.
Mammoth Energy Services (NASDAQ: TUSK) announced the sale of its engineering subsidiary Aquawolf to Qualus for an aggregate purchase price of $30.0 million on Dec 2, 2025. Aquawolf's revenue rose from $12.1M in 2022 to $17.3M in 2024, with net income increasing from $1.1M to $1.8M over the same period, and produced $12.0M revenue and $1.3M net income for the nine months ended Sept 30, 2025.
At closing Mammoth received $23.5M cash proceeds; $2.5M was placed in escrow for post-closing adjustments and indemnities through at least Dec 1, 2026. Fifth Third Bank consented and released associated collateral; the company said its borrowing base remains unchanged. Management characterized the sale as part of portfolio optimization and capital deployment to support long-term shareholder value.
Atossa (Nasdaq: ATOS) highlighted a newly published peer‑reviewed hypothesis article and an invited scientific presentation supporting the investigational therapy (Z)-endoxifen for Duchenne muscular dystrophy (DMD) and symptomatic female carriers (D‑CAPs).
The paper maps multi‑pathway mechanisms — ER modulation, PKC‑β1 inhibition, AKT/mTOR and NF‑κB effects — and notes potential advantages over tamoxifen due to more consistent exposure. Atossa plans preclinical validation and fit‑for‑purpose clinical studies focused on safety, PK/PD, functional and cardiac endpoints; a follow‑up manuscript on utrophin modulation is under review.
Atossa Therapeutics (Nasdaq: ATOS) announced four abstracts featuring (Z)-endoxifen research were accepted for presentation at the 2025 San Antonio Breast Cancer Symposium (SABCS), Dec 9-12, 2025 in San Antonio, TX. The company will present four posters on Dec 11-12 covering DCIS management, a low-dose I-SPY2 endocrine pilot, ESR1 mutant activity, and a Phase 2 neoadjuvant EVANGELINE trial.
Presentations include scheduled poster sessions on Dec 11 (12:30pm–2:00pm CT) and Dec 12 (7:00am–8:30am CT and 12:30pm–2:00pm CT).
Virax Biolabs (NASDAQ: VRAX) completed full UK recruitment for its multi-centre study of the ViraxImmune™ T cell assay in Post-Acute Infection Syndromes (PAIS), reaching the target of 160 participants in a 3:1 randomised design with 40 symptomatic patients each for Long COVID, PTLD, and ME/CFS. Clinical samples will undergo immunological analysis to evaluate assay performance to support UK regulatory filings with the MHRA and inform potential U.S. submissions.
Virax also received constructive FDA feedback from a Sept 10, 2025 pre-submission meeting and plans a U.S. clinical study with Emory University in 2026. Initial readouts are expected in Q2 2026.
Atossa Therapeutics (Nasdaq: ATOS) highlighted enrollment progress and biomarker strategy for the RECAST™ Phase 2 DCIS platform trial ahead of an Early Detection Research Conference presentation on October 21, 2025.
RECAST is a multi-arm, randomized neoadjuvant trial testing standard endocrine therapy and novel agents—(Z)-Endoxifen, elacestrant, Hav-088—with imaging, biomarker discovery, and quality-of-life endpoints. Enrollment began January 2024 with 50 of 400 patients enrolled across 17 active U.S. sites. The trial aims to identify patients suitable for long-term active surveillance and generate interim imaging and biomarker readouts to de-risk later-stage development.
Atossa Therapeutics (Nasdaq: ATOS) announced that Chairman & CEO Steven Quay, M.D., Ph.D. will present at the Maxim Growth Summit on October 22–23, 2025 at the Hard Rock Hotel, New York City.
The company invited new and existing investors to attend or request one-on-one meetings to discuss Atossa's clinical programs, development plans, and capital-allocation strategy focused on preparing data packages for potential regulatory submissions and commercialization.
Investors are directed to the Atossa investor website for presentations, SEC filings, FAQs, and meeting requests.
Atossa (NASDAQ: ATOS) appointed Mark Daniel, CPA, as Chief Financial Officer effective Oct 14, 2025 to lead finance, systems, and capital strategy as the company prepares for commercial launch of (Z)-endoxifen.
Mr. Daniel brings >25 years of life‑sciences finance experience, including weekly revenue forecasting with commercial teams, management of operating budgets >$200M, implementation and certification of SOX controls, programs delivering >$50M in cost savings, stewardship of a $400M cash and investments portfolio, and participation in nearly $1B of equity, convertible debt, and credit transactions.
Atossa Therapeutics (NASDAQ: ATOS) announced expansion of its global intellectual-property strategy for Z-endoxifen, including issuance of an Israeli patent (No. 304863) granted on July 2, 2025 and a Certificate of Patent Renewal confirming fee payment and active status.
The Israeli claims cover oral delayed-release enteric dosage forms with at least 90% Z-endoxifen, optional impurity limits (<2%), defined gastric/intestinal release characteristics, dose strengths (e.g., 1–4 mg and 8 mg), pharmacokinetic targets, and manufacturing methods that enrich the Z-isomer via crystallization and solvent control.
Stealth BioTherapeutics (NASDAQ) launched the Mito Assist™ Patient Support Program and named AnovoRx as exclusive U.S. specialty pharmacy distributor for FORZINITY™ (elamipretide) injection. FORZINITY received FDA accelerated approval on September 19, 2025 as the first treatment for Barth syndrome to improve muscle strength in patients ≥30 kg. Mito Assist provides co-pay assistance, patient assistance for uninsured or underinsured individuals, at-home subcutaneous injection training, and dedicated case management via AnovoRx. Current Expanded Access Program patients meeting the weight requirement will be contacted for transition. Commercial availability through AnovoRx is anticipated by December 2025, pending distribution readiness and payer coverage activation.