Month: March 2023

Received U.S. Food and Drug Administration (FDA) acceptance of Investigational New Drug (IND) application for CUE-102 in Wilms’ Tumor 1 (WT1)-expressing cancers and initiated dosing in a Phase 1 dose escalation monotherapy trial at 1mg/kg. Granted FDA Fast Track Designation for CUE-101 for the treatment of HPV+ recurrent/metastatic head and neck squamous cell carcinoma (R/M HNSCC) as a monotherapy and in combination with pembrolizumab (KEYTRUDA®). Presented new positive data from the ongoing Phase 1 trials of CUE-101 in combination with pembrolizumab and as a monotherapy for HPV+ (R/M HNSCC) at the Society for Immunotherapy of Cancer’s (SITC) 37th Annual Meeting on November 10, 2022. Entered into securities purchase agreements with accredited investors for a $30 million private investment in public equity (PIPE) financing. The transaction...

Telco Sales Increase 59%, Wireless Revenues Up 49%, for Year-Ended December 31, 2022 CARROLLTON, Texas, March 21, 2023 (GLOBE NEWSWIRE) — ADDvantage Technologies Group, Inc. (NASDAQ: AEY) (“ADDvantage Technologies” or the “Company”) today reported financial results for the three and 12 months ended December 31, 2022, the fourth quarter of 2022. The Company has changed its fiscal year end from September 30 to December 31 and the current fiscal year runs from January 1, 2022 through December 31, 2022 (fiscal 2022). “This was a milestone year for ADDvantage Technologies, as we grew both our segments and delivered full-year positive net income, even with a challenging fourth quarter impacted by weather and economic headwinds,” commented Joe Hart, Chief Executive Officer. “Our Telco segment drove the majority of our growth, and this...

Fourth Quarter 2022 Financial HighlightsRevenue of $402.1 million Net loss to common stockholders of $17.3 million Adjusted EBITDA(1) of $51.7 million Basic and diluted net loss per share of $0.11 Adjusted diluted net income per share(1) of $0.10 Executed contracts and awarded orders at December 31, 2022 totaling $1.9 billionFull Year 2022 Financial HighlightsRevenue of $1,638 million Net loss to common stockholders of $43.6 million Adjusted EBITDA(1) of $128.7 million Basic and diluted net loss per share of $0.29 Adjusted diluted net income per share(1) of $0.38(1) A reconciliation of the GAAP to the most comparable Non-GAAP results is included below. ALBUQUERQUE, N.M., March 21, 2023 (GLOBE NEWSWIRE) — Array Technologies (NASDAQ: ARRY) (“Array” or “the Company”), a leading provider of tracker solutions, software and...

Fiscal year 2022 net product sales from prescriptions increased by 179% to $2.5 million versus 2021Patient enrollment increased by 149% compared with 2021 SOLANA BEACH, Calif., March 21, 2023 (GLOBE NEWSWIRE) — Evoke Pharma, Inc. (NASDAQ: EVOK), a specialty pharmaceutical company focused primarily on treatments for gastrointestinal (GI) diseases with an emphasis on GIMOTI® (metoclopramide) nasal spray, today announced its financial results for the fourth quarter and full year ended December 31, 2022, and recent corporate developments. “Evoke’s fiscal year 2022 was a period of tremendous growth and progress on several key fronts. Year-over-year revenues, new prescribers, prescription fills, and patient enrollments showed significant improvement in 2022 compared with 2021. In 2021, our prime achievement was to call attention to GIMOTI’s...

Third quarter sales of $521 million, up 15% over the prior year Third quarter GAAP diluted earnings per share from continuing operations of $0.62, compared to $0.63 in Q3 FY2022 Adjusted diluted earnings per share from continuing operations of $0.75, up 19% from $0.63 in Q3 FY2022 Third quarter cash flow provided by operating activities from continuing operations of $17 million Acquired Trax, a leading provider of aircraft MRO and fleet management softwareWOOD DALE, Ill., March 21, 2023 (GLOBE NEWSWIRE) — AAR CORP. (NYSE: AIR), a leading provider of aviation services to commercial and government operators, MROs, and OEMs, today reported third quarter fiscal year 2023 consolidated sales of $521.1 million and income from continuing operations of $21.8 million, or $0.62 per diluted share. For the third quarter of the prior year,...

GUILFORD, Conn., March 21, 2023 (GLOBE NEWSWIRE) — Hyperfine, Inc. (Nasdaq: HYPR), the groundbreaking medical device company that created the Swoop® system, the world’s first FDA-cleared portable MRI system™ today announced fourth quarter and full year 2022 financial results and provided a business update. “We made measurable progress at Hyperfine over the past year. We delivered $6.8 million in revenue in 2022, received multiple FDA clearances and international approvals, including CE Marking, in recent months, and saw a large number of publications and presentations on the clinical value of Swoop published and presented via major journals and meetings. We also implemented important measures to right size our business and extend our cash runway through the end of 2025, ending the year with a healthy balance sheet....

REDWOOD CITY, Calif., March 21, 2023 (GLOBE NEWSWIRE) — Soleno Therapeutics, Inc. (Soleno) (NASDAQ: SLNO), a clinical-stage biopharmaceutical company developing novel therapeutics for the treatment of rare diseases, today provided a corporate update, and reported financial results for the fourth quarter and full-year ended December 31, 2022. Fourth Quarter 2022 and Recent Corporate HighlightsEnrollment is nearing completion in the randomized withdrawal period of Study C602, a long-term treatment study of DCCR (Diazoxide Choline) Extended-Release tablets for the treatment of Prader-Willi syndrome (PWS):58/63 (>90% of U.S. participants) have been randomized. 15/83 (18%) participants are in the U.K., where enrollment is expected to start imminently following recent approval of the protocol from the MHRA. 5 of 83 total participants...

— Record revenue of $9.5M in 4QFY22; Increase of 208% over 4QFY21 — BioXp® Revenue increased by 158% to $3.4M, in 4QFY22 over 4QFY21 SAN DIEGO, March 21, 2023 (GLOBE NEWSWIRE) — Telesis Bio Inc. (NASDAQ: TBIO), a leader in automated multi-omic and synthetic biology solutions, today reported financial results for the fourth quarter and year ended December 31, 2022 and provided financial guidance for 2023. “We are grateful to our Telesis Bio team for their tremendous efforts which resulted in strong performance in 2022 when we exceeded our revenue expectations, delivered meaningful expansion of gross margin due to favorable product mix and cost stabilization, delivered key products for our customers and achieved important milestones for our partners,” said Todd R. Nelson, PhD, CEO and founder of Telesis Bio. “We continue...

MALVERN, Pa., March 21, 2023 (GLOBE NEWSWIRE) — TELA Bio, Inc. (“TELA Bio”), a commercial-stage medical technology company focused on providing innovative soft-tissue reconstruction solutions that optimize clinical outcomes by prioritizing the preservation and restoration of the patient’s own anatomy, today reported financial results for the fourth quarter and full year ended December 31, 2022. Recent HighlightsReported revenue of $11.6 million for the fourth quarter and $41.4 million for the full year 2022, representing growth of 39% and 41%, respectively, over the corresponding periods of 2021; Increased demand for OviTex® and OviTex PRS Reinforced Tissue Matrix products during the full year 2022, resulting in a year-over-year revenue increase for each product of approximately 26% and 92%, respectively; Announced...