Month: May 2024

Initiated MNPR-101-Zr First-in-Human Phase 1 Radiopharma Clinical Trial MNPR-101-RIT Phase 1 Clinical Trial Targeted for Launch as Early as Q4 2024 or Q1 2025 WILMETTE, Ill., May 09, 2024 (GLOBE NEWSWIRE) — Monopar Therapeutics Inc. (Monopar or the Company) (Nasdaq: MNPR), a clinical-stage radiopharmaceutical company focused on developing innovative treatments for cancer patients, today announced first quarter 2024 financial results and summarized recent developments. Recent Developments The radiopharma space has had numerous positive recent developments and announcements, from acquisitions to clinical data to reimbursement rates to commercial demand. Since this past December alone, four significant acquisitions have been publicly announced or completed which have had upfront payments ranging from approximately $1 billion to over...

Closed an oversubscribed $95 million equity financing in March with Q1 2024 cash balance of $195.1 million at quarter-end, expected to provide runway into 2027 Completed in-license agreement with Cornell University for intellectual property rights, including current and future clinical data from an ongoing investigator-initiated trial of AAVrh.10hFXN (LX2006) to support regulatory discussions Interim readout of combined data set of LX2006 at multiple doses anticipated in mid-2024; Lexeo expects to provide analysis of natural history data and baseline characteristics of these study participants in advance of interim readout Phase 1/2 clinical trial of LX2020 (HEROIC-PKP2) currently recruiting patients; data update from Cohort 1 on track for 2H 2024 NEW YORK, May 09, 2024 (GLOBE NEWSWIRE) — Lexeo Therapeutics, Inc. (Nasdaq: LXEO),...

MINNEAPOLIS, May 09, 2024 (GLOBE NEWSWIRE) — Tile Shop Holdings, Inc. (Nasdaq: TTSH) (the “Company”), a specialty retailer of natural stone, man-made and luxury vinyl tiles today announced results for its first quarter ended March 31, 2024. First Quarter 2024 Summary Net Sales Decreased 10.1%Comparable Store Sales Decreased 10.2% Gross Margin of 65.8%Net Income of $1.7 Million and Adjusted EBITDA of $7.4 MillionDiluted Earnings per Share of $0.04Cash Provided by Operating Activities of $18.6 MillionEnding Cash Balance of $24.0 Million and No Long-Term Debt Management Commentary – Cabell Lolmaugh, CEO “Continued softness in existing home sales contributed to lower levels of traffic in our stores and had an adverse impact on our comparable store sales during the first quarter of 2024. Despite these challenges, we saw an improvement...

Enrollment ongoing in IMPACT Phase 2b trial of pemvidutide in Metabolic Dysfunction-Associated Steatohepatitis (MASH), with top line results expected in Q1 2025 Cash, cash equivalents and short-term investments of $182.1 million at March 31, 2024 Webcast to be held today, May 9, 2024, at 8:30 am ET GAITHERSBURG, Md., May 09, 2024 (GLOBE NEWSWIRE) — Altimmune, Inc. (Nasdaq: ALT), a clinical-stage biopharmaceutical company, today announced financial results for the first quarter ended March 31, 2024, and provided a business update. “As the obesity therapeutics space evolves, increasing attention is being placed on agents that are able to drive weight loss while addressing the quality of that weight loss and the comorbidities of obesity. With significant weight loss, preservation of lean mass and reductions in serum lipids and liver...

Income and EBITDA Growth Highlight Performance GARDEN CITY, N.Y., May 09, 2024 (GLOBE NEWSWIRE) — Lifetime Brands, Inc. (NasdaqGS: LCUT), a leading global designer, developer and marketer of a broad range of branded consumer products used in the home, today reported its financial results for the quarter ended March 31, 2024. Rob Kay, Lifetime’s Chief Executive Officer, commented, “We are pleased with our performance in the first quarter as we delivered results that were both in line with our expectations and above the broader market. While shipments for the quarter were under pressure as a result of both economic headwinds and inventory rationalization efforts among select retailers, our sell-through rates remained strong, a testament to the strength of our product offerings across channels. Further, we were able to expand our...

Govorestat NDA for Classic Galactosemia under Priority Review, PDUFA target action date of November 28, 2024Govorestat MAA under review by EMA; Day 120 3-month clock-stop extension granted; decision expected in early Q1 2025 Company discussing potential NDA submission under Accelerated Approval for govorestat for treatment of SORD Deficiency with Neurology I Division of FDANEW YORK, May 09, 2024 (GLOBE NEWSWIRE) — Applied Therapeutics, Inc. (Nasdaq: APLT) (the “Company”), a clinical-stage biopharmaceutical company developing a pipeline of novel drug candidates against validated molecular targets in indications of high unmet medical need, today reported financial results for the first quarter ended March 31, 2024. “Preparations are underway for the potential approval and commercial launch of govorestat for the treatment of...

HeadlinesQ2 revenue above the high end of the guidance range due to OEM-related adjustments; however, Company lowering its FY24 guidance and withdrawing its multi-year plan Included in Q2 results is a Goodwill impairment charge of approximately $252 million Company believes that initial success with new generative AI products, including six design wins, and early validation of its next-gen platform will provide a solid foundation to reinvigorate future growthBURLINGTON, Mass., May 09, 2024 (GLOBE NEWSWIRE) — Cerence Inc. (NASDAQ: CRNC), AI for a world in motion, today reported its second quarter fiscal year 2024 results for the quarter ended March 31, 2024. Results Summary (1,2) (in millions, except per share data)    Three Months Ended     Six Months Ended      March 31,     March 31,      2024     2023     2024     2023  GAAP...

First Quarter Total Revenue of $80.4 Million, an Increase of 12% Versus Prior Year. Total ARR of $340.1 Million, an Increase of 7% Versus Prior Year. Enterprise ARR of $248.2 Million, an Increase of 8% Versus Prior Year AUSTIN, Texas, May 09, 2024 (GLOBE NEWSWIRE) — BigCommerce Holdings, Inc. (“BigCommerce”) (Nasdaq: BIGC), an open SaaS, composable ecommerce platform for fast-growing and established B2C and B2B brands and retailers, today announced financial results for its first quarter ended March 31, 2024. “Our first quarter results reflect a good start to the year as our total revenue exceeded $80 million, up 12% year-over-year. We also delivered strong profit improvement, with net income gaining nearly 23 points as a percent of revenue compared to last year,” said Brent Bellm, CEO of BigCommerce. “Looking forward, we anticipate...

First patient dosed in open label extension (OLE) study with 25 mg daily dosing of nomlabofusp; interim data on track for Q4 2024 Positive top-line Phase 2 dose exploration study data demonstrated nomlabofusp was generally well-tolerated with dose-dependent increases in tissue frataxin levels, reinforcing therapeutic potential Biologics License Application (“BLA”) submission targeted for 2H 2025; discussions initiated with Food and Drug Administration (“FDA”) on potential to pursue accelerated approval pathway Successful $161.8 million financing strengthens cash, cash equivalents, and marketable securities to $239 million as of March 31, 2024, extending projected cash runway into 2026BALA CYNWYD, Pa., May 09, 2024 (GLOBE NEWSWIRE) — Larimar Therapeutics, Inc. (“Larimar”) (Nasdaq: LRMR), a clinical-stage biotechnology company...

1Q 2024 Total Revenue of $110.4M, a 28% Increase Year-over-Year Guiding to Full-Year 2024 Total Revenue Growth of 25%-30% at CER Raising Full-Year 2024 Galafold® Guidance on Continued Strong Demand Strong Pombiliti® + Opfolda® Launch with Increasing Rate of Commercial Patient Starts Reiterating Full-Year Non-GAAP Profitability Projected in 2024 Conference Call and Webcast Today at 8:30 a.m. ET PRINCETON, N.J., May 09, 2024 (GLOBE NEWSWIRE) — Amicus Therapeutics (Nasdaq: FOLD), a patient-dedicated global biotechnology company focused on developing and commercializing novel medicines for rare diseases, today announced financial results for the first quarter ended March 31, 2024. “Amicus delivered a great start to the year across our global business,” said Bradley Campbell, President and Chief Executive Officer of Amicus Therapeutics,...