Day: March 26, 2024

Pivotal Phase 3 Data for ANX005 in Guillain-Barré Syndrome (GBS) Expected in Second Quarter 2024 Initiation of Pivotal Phase 3 ANX007 ARCHER II Trial in Geographic Atrophy (GA) Expected in mid-2024, a Global Sham-Controlled Trial Using Vision Preservation as Primary Outcome Measure Clinical Proof-of-Concept Data with ANX1502 Oral Inhibitor of the Classical Pathway Expected in Second Half of 2024 Robust Balance Sheet with Cash, Cash Equivalents, and Short-term Investments of Approximately $260 Million as of December 31, 2023, and Anticipated Runway into mid-2026 BRISBANE, Calif., March 26, 2024 (GLOBE NEWSWIRE) — Annexon, Inc. (Nasdaq: ANNX), a biopharmaceutical company advancing a late-stage clinical platform of novel therapies for people living with devastating classical complement-mediated neuroinflammatory diseases of the body,...

All performance targets achieved in single-ascending dose (SAD) cohorts of BT-600 clinical trial Results demonstrated targeted drug delivery and absorption in the colon, with 3-4 times lower drug levels in blood Remainder of BT-600 clinical trial progressing well and on schedule Management will host conference call and webcast today at 4:30 PM Eastern / 1:30 PM Pacific SAN DIEGO, March 26, 2024 (GLOBE NEWSWIRE) — Biora Therapeutics, Inc. (Nasdaq: BIOR), the biotech company that is reimagining therapeutic delivery, today provided a corporate update and reported financial results for the fourth quarter and year ended December 31, 2023. “We are thrilled by the results from the single ascending dose (SAD) portion of our clinical trial for BT-600. The data indicate exactly what we had hoped: NaviCap devices consistently delivered tofacitinib...

GRAPEVINE, Texas, March 26, 2024 (GLOBE NEWSWIRE) — GameStop Corp. (NYSE: GME) (“GameStop” or the “Company”) today released financial results for the fourth quarter and fiscal year ended February 3, 2024. The Company’s consolidated financial statements, including GAAP and non-GAAP results, are below. The Company’s Form 10-K and supplemental information can be found at https://investor.gamestop.com. FOURTH QUARTER OVERVIEWNet sales were $1.794 billion for the fourth quarter, compared to $2.226 billion in the prior year’s fourth quarter. Selling, general and administrative (“SG&A”) expenses were $359.2 million, or 20.0% of net sales, for the fourth quarter, compared to $453.4 million, or 20.4% of net sales, in the prior year’s fourth quarter. Net income was $63.1 million for the fourth quarter, compared to net...

WINNIPEG, Manitoba, March 26, 2024 (GLOBE NEWSWIRE) — Kane Biotech Inc. (TSX- V:KNE; OTCQB:KNBIF) (the “Company” or “Kane Biotech”) today announces its fourth quarter and full year 2023 financial results. On December 20, 2023, Kane Biotech announced that it received a non-binding offer for its interest in STEM Animal Health. The terms of the offer remain confidential but specify that Kane will sell its ownership of STEM. In addition, pursuant to the terms of the offer, Kane received a US $625,000 deposit. The parties have agreed to collaborate using their best efforts to enter into a binding share purchase agreement with respect to the sale of STEM within 90 days. On March 20, 2024, Kane announced that it has extended the exclusivity period from March 19, 2024 until March 31, 2024 and that it has received additional deposits totaling...

Advances strategic review to unlock shareholder value MOUNTAIN VIEW, Calif., March 26, 2024 (GLOBE NEWSWIRE) — Iridex Corporation (Nasdaq: IRIX), a worldwide leader providing innovative and versatile laser-based medical systems, delivery devices, and procedure probes for the treatment of glaucoma and retinal diseases, today reported financial results for the fourth quarter and full year ended December 30, 2023, and provided a business update. Fourth Quarter 2023 Results & Recent HighlightsGenerated total revenue of $12.5 million, compared to $15.2 million in the prior year period Cyclo G6® product family revenue in the fourth quarter of $3.0 million, compared to $4.2 million in the prior year periodSold 12,700 Cyclo G6 probes, compared to 16,400 in the prior year quarter Sold 35 Cyclo G6 Glaucoma Laser Systems in the fourth...

PLEASANTON, Calif., March 26, 2024 (GLOBE NEWSWIRE) — ProSomnus, Inc. (NASDAQ: OSA), the leading non-CPAP therapy™ for the treatment of Obstructive Sleep Apnea (OSA), today announced financial results for the fourth quarter and year ended December 31, 2023. Recent Business HighlightsGenerated record revenues of $7.8 million for the fourth quarter and $27.7 million for the fiscal year 2023, a 35% increase compared to $5.8 million for the fourth quarter 2022 and 43% increase compared to $19.4 million for fiscal year 2022. The quarter marked the eighth (8th) sequential quarter of record revenues. Continued focus on implementing reductions in operating expenses. Operating expenses, excluding cost of revenue, decreased over 8% compared to operating expenses reported for the second quarter of 2024 and decreased nearly 19% as...

On track for regulatory filing for First-in-Human study of KRRO-110 in Alpha-1 Antitrypsin Deficiency (AATD) patients anticipated in the second half of 2024 Demonstrated the versatility of Korro’s RNA editing platform by generating de-novo protein variants via multiple targets in non-human primates (NHPs) Demonstrated greater than 50% editing using GalNAc conjugates in the liver with subcutaneous administration in a preclinical mouse model Ended 2023 with a strong balance sheet of $166 million of cash and cash equivalents, including $117 million of proceeds from a successful private financing completed in November 2023 Cash runway into 2026, which enables key readouts for KRRO-110 and progression of additional pipeline candidatesCAMBRIDGE, Mass., March 26, 2024 (GLOBE NEWSWIRE) — Korro Bio, Inc. (Korro) (Nasdaq: KRRO), a biopharmaceutical...

CAB-CTLA-4 (BA3071) Phase 1 study cleared dose-limiting toxicity (DLT) observation period with 700 mg (10 mg/kg); initial Phase 2 monotherapy data readout anticipated in 2Q 2024 and in combination with pembrolizumab in 2H 2024 CAB-ROR2 (BA3021) Phase 2 melanoma and squamous cell carcinoma of the head and neck (SCCHN) clinical trials fully enrolled; on track for data readouts in 2Q 2024 CAB-AXL (BA3011) Phase 2 potentially registrational study in undifferentiated pleomorphic sarcoma (UPS) on track for enrollment completion of approximately 20 patients in April with anticipated FDA meeting for guidance on the remaining portion of the potentially registrational trial in 2H 2024 CAB-EpCAM x CAB-CD3 (BA3182) Phase 1 dose-escalation study on track with full data readout anticipated in 2H 2024; potential initiation of Phase 2 study in 2H 2024 Cash...

Tuspetinib to Advance to TUS+VEN+HMA Triplet Therapy Pilot Study in 1L AML Tuspetinib Continues Broad Activity Across Mutations with Excellent Safety Profile Luxeptinib G3 Formulation Achieves Desired Levels and Positions for Future Trials Conference Call and Webcast at 5:00 pm ET TodaySAN DIEGO and TORONTO, March 26, 2024 (GLOBE NEWSWIRE) — Aptose Biosciences Inc. (“Aptose” or the “Company”) (NASDAQ: APTO, TSX: APS), a clinical-stage precision oncology company developing highly differentiated oral targeted agents to treat hematologic malignancies, today announced financial results for the three months and year ended December 31, 2023, and provided a corporate update. “The data we have generated from tuspetinib thus far – as a single agent and in combination therapy with venetoclax in relapsed and refractory AML – have demonstrated...