Day: March 21, 2024

Launched and enrolling Phase 2 trial of allo-iNKTs with botensilimab/balstilimab and chemotherapy in second-line gastroesophageal cancersAnnounced collaboration with Immunoscape for development of TCR-based therapies Published clinical data in Nature Communications and Oncogene demonstrating clinical activity of allo-iNKTs, agenT-797, in solid tumors and severe acute respiratory distressNEW YORK, March 21, 2024 (GLOBE NEWSWIRE) —  MiNK Therapeutics, Inc. (NASDAQ: INKT), a clinical-stage biopharmaceutical company pioneering the discovery, development, and commercialization of allogeneic, off-the-shelf, invariant natural killer T (iNKT) cell therapies to treat cancer and other immune-mediated diseases, today announced results for the fourth quarter and full-year 2023. MiNK executives will host a conference call and webcast...

Key Fiscal Year data points:Revenue of $72.2 million, -8.5% vs. 2022 Gross margin improved by 205 basis points to 24.3%, while adjusted gross margin improved by 232 basis points GAAP net loss from continuing operations of ($4.2 million) or ($0.08) per fully diluted share, compared to a 2022 loss of ($1.1 million) or ($0.02) per fully diluted share Adjusted net income from continuing operations of $1.1 million or $0.02 per fully diluted share, compared to a 2022 adjusted net loss of ($0.8 million) or ($0.02) per fully diluted share Adjusted EBITDA of $2.5 million, compared to $0.3 million last year Working Capital improved from a deficit of ($3.2 million) at the end of 2022 to a surplus of $5.0 million at the end of 2023, representing an increase of approximately $8.2 million The refinancing of company debt, USDA debt guarantee, and...

– First patient dosed with CABA-201 in the RESET™ (REstoring SElf-Tolerance) clinical trial program – – Initial clinical data from each of the first patients in the RESET-Myositis™ and RESET-SLE™ trials anticipated in 1H24; longer term follow-up on these and additional patients to be reported in 2H24 – – RESET-SSc™ (systemic sclerosis) and RESET-MG™ trials initial clinical data anticipated to be reported in 2H24 – – Rare Pediatric Disease designation granted by FDA for CABA-201 in juvenile dermatomyositis – – Cash runway into 1H26 with cash, cash equivalents and short-term investments of $241.2 million as of December 31, 2023 – PHILADELPHIA, March 21, 2024 (GLOBE NEWSWIRE) — Cabaletta Bio, Inc. (Nasdaq: CABA), a clinical-stage biotechnology company focused on developing and launching the first...

Full-Year Sales of $521.8 million, Net Income of $27.9 million, $0.43 EPS, Adjusted EBITDA of $55.9 million CANTON, Mass., March 21, 2024 (GLOBE NEWSWIRE) — Destination XL Group, Inc. (NASDAQ: DXLG), the largest integrated commerce specialty retailer of Big + Tall men’s clothing and shoes, today reported financial results for the fourth quarter and fiscal year 2023. Fourth Quarter HighlightsTotal sales for the 14-week fourth quarter were $137.1 million, down 4.7% from $143.9 million for the 13-week fourth quarter of fiscal 2022. Comparable sales for the fourth quarter decreased 10.1% as compared to the fourth quarter of fiscal 2022. Net income for the fourth quarter was $5.2 million, or $0.08 per diluted share, as compared to net income of $8.3 million, or $0.13 per diluted share, for the fourth quarter of fiscal 2022.  Results...

— Delivers Solid Gross Margin of 15.0% Demonstrating Strength of Product Diversification andVariable Cost Structure — — Completes $350 Million Offering of Convertible Senior Notes for Refinancing 2025 Maturities — — Barletta Captures 7.9% Share of U.S. Aluminum Pontoon Market(1), up 80 Basis Points YoY — — Company Introduces Future Mid-Cycle Organic Growth Targets — EDEN PRAIRIE, Minn., March 21, 2024 (GLOBE NEWSWIRE) — Winnebago Industries, Inc. (NYSE: WGO), a leading outdoor lifestyle product manufacturer, today reported financial results for the fiscal 2024 second quarter ended February 24, 2024. Second Quarter Fiscal 2024 Financial SummaryRevenues of $703.6 millionGross profit of $105.3 million, representing 15.0% gross marginNet loss of $12.7 million, or $0.43 per share,...

$19 million revenue in 2023; $24 million projected revenue in 2024NexoBrid® commercially launched in U.S., Japan, IndiaPotential blockbuster EscharEx® to begin Phase III in the second half of 2024$42 million cash runway through profitability Conference call today, March 21 at 8:30am Eastern Time YAVNE, Israel, March 21, 2024 (GLOBE NEWSWIRE) — MediWound Ltd. (Nasdaq: MDWD), the global leader in next-generation enzymatic therapeutics for tissue repair, today announced financial results for the fourth quarter and full year ended December 31, 2023, and provided a corporate update. “2023 was an exceptional year for NexoBrid driven by new market launches, expanded indications, substantial new governmental grants, and increased global demand. Additionally, this lifesaving treatment was successfully battle-tested in real-life burn mass...

Interim clinical data update on ACTengine® IMA203 GEN1 (PRAME) in melanoma at RP2D in November 2023: 50% confirmed objective response rate with median duration of response not reached at median follow-up of 14.4 months; IMA203 was well tolerated Registration-enabling randomized Phase 2/3 trial for ACTengine® IMA203 GEN1 in 2L+ melanoma planned to begin in 2024 Next data update on IMA203 GEN1 and IMA203CD8 GEN2 planned for 2H 2024First clinical data updates for Immatics’ next-generation TCR Bispecifics, TCER® IMA401 (MAGEA4/8) and TCER® IMA402 (PRAME), from ongoing Phase 1 dose escalation trials planned for 2H 2024; updates to include details on safety, pharmacokinetics and initial anti-tumor activity In May 2023, Bristol Myers Squibb exercised first opt-in into the autologous cell therapy collaboration ($15 million option fee received)...

InflaRx will focus development activities and resources initially on selected indications in immuno-dermatology, with registrational-phase vilobelimab and potentially best-in-class oral C5aR inhibitor INF904INF904 development will be initially targeted at chronic spontaneous urticaria (CSU) and hidradenitis suppurativa (HS), with initiation of a Phase IIa PK dose-ranging study expected by the end of 2024, with data availability anticipated in 2025InflaRx is considering partnership options for INF904 in additional areas of interest with a goal of unlocking its “pipeline-in-a-product” potential more broadlyOngoing Phase III trial with vilobelimab in pyoderma gangrenosum (PG) is expected to have an interim analysis in 2025Cash, cash equivalents and marketable securities of €98.4 million expected to fund operations at least...

Q2 GAAP revenues of $545.9 million, up 6.0% from Q2 2023. Organic Q2 ASV plus professional services of $2,209.5 million, up 5.4% year over year. Q2 GAAP operating margin of 33.3%, up approximately 50 bps year over year, and adjusted operating margin of 38.3%, up approximately 130 bps from the prior year. Q2 GAAP diluted EPS of $3.65, up 8.0% from the prior year, and adjusted diluted EPS of $4.22, up 11.1% year over year. Top-line growth expected at the lower end of the previously published guidance ranges for the fiscal year: ASV plus professional services growth of $110 – $150 million and GAAP revenues between $2,200 – $2,210 million.NORWALK, Conn., March 21, 2024 (GLOBE NEWSWIRE) — FactSet (“FactSet” or the “Company”) (NYSE:FDS) (NASDAQ:FDS), a global financial digital platform and enterprise solutions provider,...

 – Enrollment in the two pivotal trials of lorundrostat for the treatment of uHTN or rHTN is on track, with topline data expected for Advance-HTN trial in Q4 2024 and Launch-HTN trial in 2H 2025 – – Explore-CKD Phase 2 trial, a study for lorundrostat in hypertensive patients with stage 2-3b CKD on track for Q4 2024 to Q1 2025 topline data – – Conference call today at 8:30 a.m. ET – RADNOR, Pa., March 21, 2024 (GLOBE NEWSWIRE) — Mineralys Therapeutics, Inc. (Nasdaq: MLYS), a clinical-stage biopharmaceutical company focused on developing medicines to target hypertension, chronic kidney disease (CKD) and other diseases driven by abnormally elevated aldosterone, today announced financial results for the fourth quarter and full year ending December 31, 2023, and provided a corporate update. “Throughout 2023 we accomplished key milestones...