Month: May 2022

First quarter 2022 results reflect strong CAPLYTA® (lumateperone) launch in bipolar depression  First quarter 2022 CAPLYTA new and total prescriptions increased 63% and 45%, respectively, versus the fourth quarter 2021     First quarter 2022 CAPLYTA new and total prescriptions increased 154% and 134%, respectively, versus the same period in 2021     New-to-brand CAPLYTA prescriptions, representing new patient starts, have increased approximately 300% following bipolar depression approvalTotal revenues for the first quarter 2022 were $35 million, compared to $15.9 million for the same period in 2021, representing a 120% increase CAPLYTA net product revenues of $34.8 million for the first quarter 2022, representing a 36% increase over the fourth quarter 2021 and a 123% increase over the same period in 2021 NEW YORK, May...

           – 20% growth in CGuard™ revenue Year-over-Year –            – C-Guardian FDA IDE Trial Completes First European Enrollment –            – Held Key Opinion Leader (KOL) Webinar on Carotid Artery Disease Management and Stroke Prevention, highlighting CGuard™ clinical advantages –            – European logistics hub established with BOMI Group –for direct market access as well as establishing the commercial footprint for a growing portfolio of new systems across different channels –            – Upcoming Clinical Evidence and Live Case to be presented at LINNC 2022- —Management to Host Investor Conference Call Today, May 10, at 8:30am ET— TEL AVIV, Israel, May 10, 2022 (GLOBE NEWSWIRE) — InspireMD, Inc. (Nasdaq: NSPR), developer of the CGuard™ Embolic Prevention...

NEW YORK , May 10, 2022 (GLOBE NEWSWIRE) — Delcath Systems, Inc. (Nasdaq: DCTH), an interventional oncology company focused on the treatment of primary and metastatic cancers of the liver, today reported business highlights and financial results for the first quarter ended March 31, 2022. Recent Business Highlights During and since the first quarter, Delcath:Held a pre-NDA meeting with FDA and announced plans to file an NDA in the third quarter of 2022, Announced the acceptance of a poster presentation updating results from the FOCUS Phase 3 Trial at the upcoming American Society of Clinical Oncology (ASCO) 2022 Annual Meeting, Resumed direct responsibility for sales, marketing, and distribution activities for the CHEMOSAT® Hepatic Delivery System in all of Europe, Achieved medical device regulation (MDR) certification for CHEMOSAT in...

CHICAGO, May 10, 2022 (GLOBE NEWSWIRE) — Whole Earth Brands, Inc. (the “Company” or “we” or “our”) (Nasdaq: FREE), a global food company enabling healthier lifestyles through premium plant-based sweeteners, flavor enhancers and other foods, today announced its financial results for its first quarter ended March 31, 2022. The Company also reaffirmed fiscal year 2022 guidance. First Quarter HighlightsReported consolidated revenue growth of 23%, including a full quarter of the Wholesome acquisition compared to approximately two months in the prior year period First quarter proforma organic constant currency revenue growth of approximately 5% Branded CPG proforma organic constant currency revenue growth of approximately 3% compared to 2021 Flavors & Ingredients revenue growth of approximately 12% compared to 2021 Operating income...

Financial HighlightsDouble-Digit Revenue Growth Highlighting Strong Fundamentals Healthy Streaming Performance Driven by Growth in Traditional and Emerging Streaming Platforms Strong Margins Despite Continued Recovery in Lower-Margin Artist Services Revenue Continued Momentum in Music Publishing with Double-Digit Revenue Growth and Margin ImprovementFor the three months ended March 31, 2022Total revenue grew 10% or 13% in constant currency Digital revenue grew 8% or 11% in constant currency Net income was $92 million versus $117 million in the prior-year quarter OIBDA increased 12% to $255 million versus $228 million in the prior-year quarter Adjusted OIBDA increased 7% to $274 million versus $255 million in the prior-year quarter Adjusted EBITDA increased 5% to $282 million versus $268 million in the prior-year quarterNEW YORK,...

– SNS-101 preclinical data provide encouraging validation of pH-sensitive approach to inhibiting VISTA with high selectivity to treat solid tumors – – Cash runway extended into the first quarter of 2025 with $136.2 million on hand at end of first quarter 2022 – BOSTON, May 10, 2022 (GLOBE NEWSWIRE) — Sensei Biotherapeutics, Inc. (NASDAQ: SNSE), an immunotherapy company focused on the discovery and development of next generation therapeutics for cancer, today reported financial results for the first quarter ended March 31, 2022, and provided recent corporate updates. “We continue to make significant progress in the development of our TMAb™ platform, which is designed to address the challenge of resistance to checkpoint blockade. New preclinical data show that SNS-101, our anti-VISTA antibody, binds selectively...

– Recently reported positive preliminary biomarker and safety data from ongoing Phase 1/2 clinical trial of INZ-701 in ENPP1 Deficiency – – Preliminary biomarker and safety data from ongoing Phase 1/2 trial of INZ-701 in ABCC6 Deficiency on track for the second quarter of 2022 – – Cash, cash equivalents and investments as of quarter end, together with proceeds from April 2022 offering, extends runway into the fourth quarter of 2023 – BOSTON, May 10, 2022 (GLOBE NEWSWIRE) — Inozyme Pharma, Inc. (Nasdaq: INZY), a clinical-stage rare disease biopharmaceutical company developing novel therapeutics for the treatment of abnormal mineralization, today reported financial results for the first quarter ended March 31, 2022 and provided recent business highlights. “Inozyme is off to an exceptionally strong start for the year. We now have...

Oral presentation at 2022 ASCO annual meeting to highlight initial data from ongoing Phase 1/2 PYNNACLE study of PC14586 in patients with advanced solid tumorsCRANBURY, N.J., May 10, 2022 (GLOBE NEWSWIRE) — PMV Pharmaceuticals, Inc. (Nasdaq: PMVP), a precision oncology company pioneering the discovery and development of small molecule, tumor-agnostic therapies targeting p53, today reported financial results for the first quarter ended March 31, 2022, and provided a corporate update. “Our priority in 2022 is execution of the ongoing Phase 1/2 trial evaluating PC14586, our investigational first-in-class p53 Y220C reactivator, in patients with solid tumors, as well as continued progress on our pipeline” said David Mack, Ph.D., President, and Chief Executive Officer. “We look forward to presenting initial data from the Phase 1 dose...

Total GAAP revenue increased 40.1% year-over-year to $75.0 million Annual recurring revenue (ARR) increased 37.6% year-over-year to $305.9 million Total number of customers reached approximately 49,600 Cash flow from operations was $25.1 million and free cash flow was $23.4 millionTAMPA BAY, Fla., May 10, 2022 (GLOBE NEWSWIRE) —  KnowBe4, Inc. (NASDAQ: KNBE), provider of the leading security awareness training and simulated phishing platform, today reported results for the first quarter ended March 31, 2022. “We are pleased to report another outstanding quarter with ARR reaching $305.9 million and total customers closing in on 50,000.” said Stu Sjouwerman, founder and chief executive officer of KnowBe4. “As current geopolitical events have indicated, the need for organizations to establish a strong security culture has never...

U.S. Food and Drug Administration (FDA) approval received for VOQUEZNA™ TRIPLE PAK™ (vonoprazan, amoxicillin, clarithromycin) and VOQUEZNA™ DUAL PAK™ (vonoprazan, amoxicillin) for treatment of H. pylori infection in adultsUp to $260 million revenue interest financing agreement strengthens balance sheet with non-dilutive financingFLORHAM PARK, N.J., May 10, 2022 (GLOBE NEWSWIRE) — Phathom Pharmaceuticals, Inc. (Nasdaq: PHAT), a biopharmaceutical company focused on developing and commercializing novel treatments for gastrointestinal diseases, today reported financial results for the first quarter of 2022 and provided updates on recent clinical, regulatory, and business progress. “Phathom demonstrated strong execution on several key initiatives throughout the start of 2022, resulting in the accomplishment of important regulatory...