Month: August 2022

NORCROSS, Ga., Aug. 15, 2022 (GLOBE NEWSWIRE) — Galectin Therapeutics, Inc. (NASDAQ: GALT), the leading developer of therapeutics that target galectin proteins, today reported financial results and provided a business update for the three months ended June 30, 2022. These results are included in the Company’s Quarterly Report on Form 10-Q, which has been filed with the U.S. Securities and Exchange Commission and is available at www.sec.gov. Joel Lewis, Chief Executive Officer and President, stated: “Our team made significant progress on a number of fronts this quarter. The most consequential action for the Company undoubtedly was finalizing a $60 million line of credit facility from Richard Uihlein. Proceeds from this very favorable financing arrangement are expected to cover all our currently projected costs for the Phase...

WALTHAM, Mass., Aug. 15, 2022 (GLOBE NEWSWIRE) — Aerovate Therapeutics, Inc. (Nasdaq: AVTE), a clinical stage biopharmaceutical company focused on developing drugs that meaningfully improve the lives of patients with rare cardiopulmonary disease, today announced financial results for the quarter ended June 30, 2022, and recent business highlights. Recent HighlightsProgress Continued for IMPAHCT Global Phase 2b/Phase 3 Clinical Trial Presented Phase 1 Results at ATS Expanded Intellectual Property Portfolio Management Team StrengthenedProgress Continued for IMPAHCT Global Phase 2b/Phase 3 Clinical Trial. IMPAHCT (Inhaled iMatinib Pulmonary Arterial Hypertension Clinical Trial) is a Phase 2b/Phase 3 trial of AV-101, our dry powder inhaled formulation of the anti-proliferative drug imatinib for the treatment of pulmonary arterial...

– Added an anticipated additional year of runway into 2025 through securing non-dilutive debt facility from Hercules combined with execution of cost optimizations by prioritizing atai’s development programs with anticipated meaningful near-term clinical value inflections– Key achieved R&D milestones include completion of the clinical phase of the Drug-Drug-Interaction (DDI) study of PCN-101, database lock for the GRX-917 Phase 1 trial, completion of SAD portion of ongoing KUR-101 Phase 1 trial, and initiation of VLS-01 Phase 1 trial– Non-dilutive financing facility of up to $175M, plus $312M existing cash on hand as of June 30, 2022, gives atai access to up to $487M to continue developing next generation mental health treatments Video interview with Management to be posted today at 8:30 a.m. EDT NEW YORK and BERLIN,...

• Prioritized pipeline to focus on most advanced programs while maintaining financial flexibility to pursue business development opportunities • Appointed Rachel Humphrey, M.D., a senior biotech executive with extensive experience in drug development, to its Board of Directors • Cash balance of $207 million as of August 15, 2022 expected to provide runway through initial clinical value inflections for two lead pipeline programs CAMBRIDGE, Mass., Aug. 15, 2022 (GLOBE NEWSWIRE) — Pyxis Oncology, Inc. (Nasdaq: PYXS), a diversified oncology company focused on developing an arsenal of next-generation therapeutics to target difficult-to-treat cancers and improve quality of life for patients, today reported financial results for the second quarter and six months ended June 30, 2022 and provided a corporate update. “Our strong balance...

Advancing TCR-T Library Phase 1/2 trial targeting KRAS, TP53 and EGFR mutations across six solid tumor indications; plan to present early data in 3Q 2022 at a scientific conference; moving ahead with second dose levelExtended Cooperative Research and Development Agreement for development of personalized TCR-T cell therapies with the National Cancer Institute of the National Institute of Health to 2025Appointed Abhishek Srivastava, Ph.D. as VP, Technical OperationsAdvancing multi-pronged strategy to bolster in-house manufacturing capacityOperating cash burn in 2Q 2022 was $8.2 million, a decrease of 62% from the same period last yearHOUSTON, Aug. 15, 2022 (GLOBE NEWSWIRE) — Alaunos Therapeutics, Inc. (“Alaunos” or the “Company”) (Nasdaq: TCRT), a clinical-stage oncology-focused cell therapy company today announced financial...

BREXAFEMME® (ibrexafungerp tablets) prescriptions in Q2 2022 increased 29 percent over Q1 2022, generating net revenues of $1.3 million in Q2 2022, compared to $0.7 million in Q1.SCYNEXIS filed a supplemental New Drug Application (sNDA) to expand BREXAFEMME’s labelling to include the prevention of recurrent vulvovaginal candidiasis (RVVC); the FDA assigned a target PDUFA action date of November 30, 2022 for this additional indication. Enrollment has begun in two Phase 3 trials: the MARIO study is evaluating ibrexafungerp as an oral step-down treatment for invasive candidiasis (IC), and the VANQUISH study is evaluating ibrexafungerp for VVC patients that have failed treatment with fluconazole therapy. Based on a cash balance of $118.7 million at June 30, 2022, SCYNEXIS has a projected cash runway into Q1 2024. SCYNEXIS will host a conference...

Amy Mahery Amy MaheryEarly launch data for VTAMA® (tapinarof) with approximately 14,000 prescriptions written by more than 3,000 unique prescribers in initial eleven weeks of launch shows strong demand for first topical novel chemical entity for plaque psoriasis in 25 years The Journal of the American Academy of Dermatology (JAAD) published the Phase 3 long-term extension study highlighting the unique mechanism for the remittive effect of VTAMA showing mean duration off-therapy for patients achieving PGA=0 was 130 days Dermavant’s Japanese partner reported positive Phase 3 data for tapinarof for the treatment of atopic dermatitis (AD), including statistically significant results on the IGA and EASI scores, and plans to submit for approval in Japan Enrollment in Priovant’s potentially registrational trial for brepocitinib in systemic...

— Extended Cash Runway Into 2024 With US$20 Million Raise To Complete Phase 1/2 ABILITY Study And Advance Pipeline — New MDNA11 Data From Dose Escalation in ABILITY Study Shows Tumor Control In Four Of Ten Evaluable Patients Including Unconfirmed Partial Response In Pancreatic Cancer Patient — ABILITY Study Commences Enrolling In Its Fifth Dose Escalation Cohort With No Dose-Limiting Toxicities Reported To Date — Additional Clinical Results Including Tumor Control Data From Fourth And Fifth Dose Escalation Cohorts Expected During The Second Half Of Calendar 2022 — Management Hosting Conference Call And Webcast Today At 8:30 am EDT TORONTO and HOUSTON, Aug. 15, 2022 (GLOBE NEWSWIRE) — Medicenna Therapeutics Corp. (“Medicenna” or “the Company”) (NASDAQ: MDNA, TSX: MDNA), a clinical stage immunotherapy...

Topline results from the Phase 2 VISIONARY-MS clinical trial with CNM-Au8® met the primary and secondary endpoints of Low Contrast Letter Acuity (LCLA) and modified Multiple Sclerosis Functional Composite (mMSFC) compared to placebo over 48 weeks in the mITT populationUpdated data from RESCUE-ALS demonstrate a statistically significant decrease in mortality in participants who entered open-label extension study (5 CNM-Au8 deaths vs. 14 placebo deaths, HR=0.301, p=0.0143)Topline results from HEALEY ALS Platform Trial expected this quarterCash, cash equivalents and marketable securities of $26.3 million as of June 30, 2022Entered into a $3.0 million loan facility from State of Maryland to support development of commercial manufacturing facilitySALT LAKE CITY, Aug. 15, 2022 (GLOBE NEWSWIRE) — Clene Inc. (Nasdaq: CLNN)...