Day: March 16, 2023

– Company expecting Investigational New Drug (IND) clearance in the first half of 2023 for CABA-201, a 4-1BB-containing fully human CD19-CAR T cell therapy, with potential to generate initial clinical data by the first half of 2024 – PHILADELPHIA, March 16, 2023 (GLOBE NEWSWIRE) — Cabaletta Bio, Inc. (Nasdaq: CABA), a clinical-stage biotechnology company focused on developing and launching the first curative targeted cell therapies for patients with autoimmune diseases, today reported financial results for the fourth quarter and full year ended December 31, 2022, and provided a business update. “As we seek FDA clearance for CABA-201 in the next few months, we believe that our specifically designed product candidate for autoimmune patients, our experience with efficient autoimmune cell therapy clinical trial design coupled with...

Continued consumer purchases (scanned retail sales) growth of 24% for the 52 weeks ended January 28, 20231Q1 2023 net revenue decreased to $5.0 million, compared to $7.0 million in Q1 2022, mainly due to the remaining balance of an initial pipeline fill in Q1 2022 and a reduction in inventory on hand by the exclusive Canadian distributor in Q1 2023 Sustained strong gross margin of 53.7% in Q1 2023, compared to 54.5% in Q1 2022 Adjusted EBITDA2 loss of $2.6 million in Q1 2023, versus a $3.0 million loss in Q1 2022 Strong financial position with over $52.5 million in cash and cash equivalents, short-term investments and unused credit facilities, reflecting prudent balance sheet management Subsequent to Q1, appointment of Rajaa Grar as Chief Revenue Officer, an award-winning brand marketing and digital global leader, to drive GURU’s...

Reports Fourth Quarter 2022 Loss Lower than Prior GuidanceExpects Double-Digit Operating Margins in Back Half of 2023Expects a Return to Profitability for Full Year 2023 SECAUCUS, N.J., March 16, 2023 (GLOBE NEWSWIRE) — The Children’s Place, Inc. (Nasdaq: PLCE), the largest pure-play children’s specialty apparel retailer in North America, today announced financial results for the fourth quarter and fiscal year ended January 28, 2023. Jane Elfers, President and Chief Executive Officer commented, “As we previously announced, our 2022 operating results were negatively impacted by unprecedented input costs – the spike in cotton prices, airfreight, and container costs. While we still need to work through this higher cost inventory during the front half of 2023, input cost reductions in the back half of 2023, combined with our strong...

–-Registration Trial for uUTI Ongoing and On Track-––-Cash Runway until Mid-2024– –Company to host conference call today at 8:30amET– DUBLIN, Ireland and CHICAGO, March 16, 2023 (GLOBE NEWSWIRE) — Iterum Therapeutics plc (Nasdaq: ITRM), a clinical-stage pharmaceutical company focused on developing next generation oral and IV antibiotics to treat infections caused by multi-drug resistant pathogens in both community and hospital settings, today reported financial results for the fourth quarter and year ended December 31, 2022. “We made significant progress in 2022 to move the clinical development of oral sulopenem forward leading to a potential resubmission of our new drug application (“NDA”) next year,” said Corey Fishman, Iterum’s Chief Executive Officer. “Enrollment in our REASSURE trial, which...

– 19% Full Year Adjusted EBITDA Growth – – 7% Full Year Organic Revenue Growth – – Acquisition by GI Partners for $12.25 per share remains on track to close in Second Quarter 2023 – AUSTIN, Texas, March 16, 2023 (GLOBE NEWSWIRE) — Atlas Technical Consultants, Inc. (Nasdaq: ATCX) (“Atlas” or the “Company”), a leading infrastructure and environmental services provider, announced today results for the fourth quarter and full year ended December 30, 2022. Fourth Quarter 2022 Highlights:(all comparisons versus the prior-year period unless otherwise noted)Gross revenue grew 4% to $151.0 million. Gross margin, excluding subcontractor costs, was 61.4%, up 400 basis points; operating margin, excluding subcontractor costs, was 7.5%, up 320 basis points. Net loss was $4.2 million. Adjusted net income...

CAMBRIDGE, Mass., March 16, 2023 (GLOBE NEWSWIRE) — Evelo Biosciences, Inc. (Nasdaq: EVLO), (“Evelo” or the “Company”) a clinical stage biotechnology company developing a novel platform of orally delivered inflammation-resolving medicines acting on the small intestinal axis, SINTAX, today reported financial results and business highlights for the fourth quarter and full year 2022. “We continued to progress on our SINTAX platform and our clinical pipeline in 2022. We look forward to important clinical milestones in 2023. On mechanism of action, we have shown that the action of SINTAX medicines in the small intestine generates systemically circulating regulatory T cells. These T cells have the potential to induce durable resolution of inflammation throughout the body, as observed in Part B of the EDP1815 Phase 2 study in psoriasis...

2022 total revenues of $26.5 million FDA approval of NexoBrid® in December 2022; U.S. commercial availability expected in the second quarter of 2023 EscharEx® Phase III protocol design is under review by the FDA; study to be initiated in the second half of 2023 Cash position of $66 million, including cash received for the NexoBrid approval milestone and recent equity financing Conference call begins today at 8:30 a.m. Eastern Time YAVNE, Israel, March 16, 2023 (GLOBE NEWSWIRE) — MediWound Ltd. (NASDAQ: MDWD), a fully integrated biopharmaceutical company focused on next-generation biotherapeutic solutions for tissue repair and regeneration, today announced financial results for the fourth quarter and the year ended December 31, 2022 and provided a corporate update. “The year 2022 was truly transformative for MediWound on...

Clarified path to potential launch YUTREPIA upon resolution of litigation in late-2023 to mid-2024 Fortified financial position through 2024 Company to host webcast today at 8:30 a.m. ETMORRISVILLE, N.C., March 16, 2023 (GLOBE NEWSWIRE) — Liquidia Corporation (NASDAQ: LQDA) (“Liquidia” or the “Company”) today reported financial results for the full year ended December 31, 2022. The Company will host a webcast at 8:30 a.m. ET to discuss the 2022 financial results and provide a corporate update. Roger Jeffs, Liquidia’s Chief Executive Officer, said: “We made notable strides toward unlocking the full potential of Liquidia in 2022. Our legal and patent wins were major achievements, clarifying the path to legal resolution. If approved, YUTREPIA will provide patients with pulmonary arterial hypertension (PAH) and pulmonary hypertension...

Delivers Fourth Quarter Revenue to Achieve Full Year 2022 Revenue Outlook LOS ANGELES, March 16, 2023 (GLOBE NEWSWIRE) — The Honest Company (NASDAQ: HNST), a digitally-native consumer products company born in the Gen Z era to make purpose-driven consumer products designed for all people, today reported fourth quarter and full year 2022 financial results for the year ended December 31, 2022. “Honest’s mission to provide purpose-driven and purpose-designed products that reflect an ever-diversifying set of consumers is as meaningful today as when it was launched 11 years ago. Since joining Honest, just over two months ago, I’ve been impressed with the quality of the products, the strength of the brand, and the commitment of our teams and partners,” said Chief Executive Officer, Carla Vernón. “Honest is a brand with a demonstrated...

DODGEVILLE, Wis., March 16, 2023 (GLOBE NEWSWIRE) — Lands’ End, Inc. (NASDAQ: LE) today announced financial results for the fourth quarter and full year of the fiscal year ended January 27, 2023 compared to the fourth quarter and full year of the fiscal year ended January 28, 2022. The Company also provided the first quarter and full year fiscal 2023 outlook. Andrew McLean, Chief Executive Officer, stated, “We executed well throughout the fourth quarter to deliver sequential sales and margin improvement in each month of the quarter, resulting in revenue and adjusted EBITDA at the higher end of our expectations. We are pleased to see this momentum continue in the first quarter, particularly in our core swim category.” McLean, continued, “Looking ahead in 2023 and beyond, we plan to continue to focus on providing high-quality products...