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Day: May 9, 2024

Applied Therapeutics Reports First Quarter 2024 Financial Results

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...

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Cerence Announces Second Quarter Fiscal Year 2024 Results

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...

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BigCommerce Announces First Quarter 2024 Financial Results

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...

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Larimar Therapeutics Reports First Quarter 2024 Operating and Financial Results

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...

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Amicus Therapeutics Announces First Quarter 2024 Financial Results and Corporate Updates

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,...

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Monte Rosa Therapeutics Announces First Quarter 2024 Financial Results and Provides Corporate Update

MRT-2359, a molecular glue degrader (MGD) being developed for MYC-driven solid tumors, advancing in ongoing Phase 1/2 clinical trial; determination of recommended Phase 2 dose expected in Q2 2024; Phase 1 clinical data anticipated in H2 2024 MRT-6160, a VAV1-directed MGD in development for systemic and neurological autoimmune diseases, on track toward expected IND submission in Q2 2024 and initiation of Phase 1 SAD/MAD study mid-year; Phase 1 clinical data expected in Q1 2025 MRT-8102, a first-in-class NEK7-directed MGD and NLRP3/IL-1β pathway inhibitor, demonstrated efficient blood-brain barrier penetration and CNS activity in non-human primates (NHPs); IND submission on track for Q1 2025 New discovery program unveiled for CCNE1-directed MGDs; first to directly drug important, previously undruggable solid tumor oncology target Strong...

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BioXcel Therapeutics Reports First Quarter 2024 Financial Results

     Advancing TRANQUILITY and SERENITY program plans for two pivotal Phase 3 trials to expand BXCL501 market potential in acute treatment of agitation Strengthened intellectual property portfolio for BXCL501 with grant of two new patents, in Japan and the U.S. Completed $25 million registered direct offering Conference call set for 8:00 a.m. ET today NEW HAVEN, Conn., May 09, 2024 (GLOBE NEWSWIRE) — BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a biopharmaceutical company utilizing artificial intelligence to develop transformative medicines in neuroscience and immuno-oncology, today announced its financial results for the first quarter of 2024. “The fundamentals of our business are strong as we look to continue advancing and expanding our agitation portfolio,” said Vimal Mehta, Ph.D., CEO of BioXcel Therapeutics. “We have designed...

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LanzaTech Announces First Quarter 2024 Financial Results and Reiterates Full Year 2024 Outlook

Achieved total revenue of $10.2 million for first quarter 2024 in-line with annual guidance and consistent with outlook of back-end weighted full year 2024 revenue Reiterating full year 2024 outlook including total revenue of $90 – $105 million Cash, restricted cash, and investments of $92.3 million at March 31, 2024 CHICAGO, May 09, 2024 (GLOBE NEWSWIRE) — LanzaTech Global, Inc. (Nasdaq: LNZA) (“LanzaTech” or the “Company”), the carbon recycling company transforming waste carbon into sustainable raw materials, today reported its financial and operating results for the first quarter 2024 and reiterated its previously issued financial outlook for full year 2024. “We delivered first quarter financial results in-line with our previously issued annual guidance, while achieving a key milestone with Project SECURE, showcasing...

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Black Diamond Therapeutics Reports First Quarter 2024 Financial Results and Provides Corporate Update

Initial Phase 2 data of BDTX-1535 in 2L/3L EGFRm NSCLC patients on track for Q3 2024 Enrollment ongoing in Phase 2 trial of BDTX-1535 in 1L patients with non-classical EGFRm NSCLC; initial data expected Q1 2025 Presented real world evidence on the evolving EGFR mutation landscape in NSCLC, and the potential of BDTX-1535 across multiple lines of therapy at the 2024 AACR annual meeting Poster presentations upcoming June 1st at 2024 ASCO Annual Meeting on BDTX-1535 in GBM patients: Phase 1 dose-escalation data and initial “window of opportunity” trial results Cash, cash equivalents, and investments of $115.2 million as of March 31, 2024, expected to be sufficient to fund operations into Q3 of 2025CAMBRIDGE, MA, May 09, 2024 (GLOBE NEWSWIRE) — Black Diamond Therapeutics, Inc. (Nasdaq: BDTX), a clinical-stage oncology company developing...

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SPS Commerce Acquires Traverse Systems

Acquisition expands company’s product portfolio in supply chain performance and optimization Company to host conference call today at 8:30 a.m. ET MINNEAPOLIS, May 09, 2024 (GLOBE NEWSWIRE) — SPS Commerce, Inc. (NASDAQ: SPSC), a leader in retail supply chain cloud services, today announced the acquisition of Traverse Systems, an industry leading SaaS platform that provides retailers and their merchandise suppliers a unified view of supply chain performance to improve collaboration and enhance the consumer experience. Traverse Systems provides scorecarding and vendor performance management solutions for retailers, driving supply chain efficiencies such as increased on-time and in-full shipments, enhanced inventory accuracy, greater visibility into inbound shipments, real-time disruption management, and improved invoice accuracy. “Retailers...

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