Year: 2021

Provided initial clinical update from its Phase 3 (FREEDOM-1) clinical trial evaluating FCR001 in living donor kidney transplant patients Initiated Phase 2 (FREEDOM-2) clinical trial for FCR001 in delayed tolerance induction patients BOSTON and LOUISVILLE, Ky., Nov. 12, 2021 (GLOBE NEWSWIRE) — Talaris Therapeutics, Inc. (Nasdaq: TALS), a late-clinical stage cell therapy company developing therapies with the potential to transform the standard of care in solid organ transplantation, certain severe autoimmune diseases, and certain severe non-malignant blood, immune and metabolic disorders, today reported financial results for the three- and nine-month periods ended September 30, 2021, and provided an update on its business. “We made significant progress in the quarter, providing our first Phase 3 clinical update in living donor kidney...

Ended the quarter with nearly $103M in cash and cash equivalents UNIONDALE, N.Y., Nov. 12, 2021 (GLOBE NEWSWIRE) — Angion Biomedica Corp (NASDAQ:ANGN), a late-stage biopharmaceutical company focused on the discovery, development, and commercialization of novel small molecule therapeutics to address acute organ injuries and fibrotic diseases, today provided a corporate update and reported financial results for the quarter ended September 30, 2021. “We continue to expect enrollment of the first patient in our exploratory global Phase 2 trial of ANG-3070 in primary proteinuric diseases before the end of the year. Based upon the Phase 1 data we reported earlier in the year, we believe ANG-3070, if approved, has the potential to be a best-in-class oral TKI for patients with kidney and lung fibrosis,” said Dr. Jay R. Venkatesan, Angion’s...

NOT FOR DISTRIBUTION TO U.S. NEWSWIRES OR OTHER DISSEMINATION IN THE UNITED STATES TORONTO, Nov. 12, 2021 (GLOBE NEWSWIRE) — Ceres Acquisition Corp. (NEO: CERE.U, CERE.WT; OTCQX: CERAF) (“Ceres” or the “Corporation”) is reporting its financial results as at September 30, 2021, and for the three and nine month periods then ended. The Corporation’s unaudited financial statements, along with the accompanying management’s discussion and analysis, have been filed on the System for Electronic Document Analysis and Retrieval (SEDAR) and may be viewed by interested parties under the Corporation’s profile at www.sedar.com. The Corporation is confident in its abilities to identify, evaluate and execute an attractive qualifying transaction by continuing to leverage its network to source a wide spectrum of meaningful investment opportunities. About...

Reports Third Quarter 2021 Operating & Financial Results Company to discontinue MarzAA development; focus on developing its complement portfolio Management to host a call today at 8:30 am ET SOUTH SAN FRANCISCO, Calif., Nov. 12, 2021 (GLOBE NEWSWIRE) — Catalyst Biosciences, Inc. (NASDAQ: CBIO) today announced a strategic decision to halt the clinical development of MarzAA, report data to date, and seek a buyer for its hemophilia assets. Catalyst plans to focus its resources on its complement therapeutics and protease medicines platform. The Company also reported its operating and financial results for the third quarter ended September 30, 2021. “We have made a strategic decision to stop the clinical development of MarzAA (engineered FVIIa) and focus solely on our complement programs and protease medicines platform. Based...

–-Type B meeting with FDA requested to affirm design for additional Phase 3 trial needed for resubmission of NDA for Oral Sulopenem– –Cash Runway into 2024–    –Iterum to host conference call today at 8:30am ET– DUBLIN, Ireland and CHICAGO, Nov. 12, 2021 (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 third quarter ended September 30, 2021. “We had a productive Type A meeting with the U.S. Food and Drug Administration (FDA) in the third quarter in which various potential paths forward to support potential resubmission of our New Drug Application...

TORONTO, Nov. 12, 2021 (GLOBE NEWSWIRE) — Venus Concept Inc. (“Venus Concept” or the “Company”) (NASDAQ: VERO), a global medical aesthetic technology leader, announced financial results for the three and nine months ended September 30, 2021. Third Quarter 2021 Summary & Recent Highlights:Total revenue of $24.6 million, up $3.9 million, or 19%, year-over-year.U.S. revenue of $13.0 million, up $5.2 million, or 67%, year-over-year. Total subscription and system revenue of $20.7 million, up $3.7 million, or 22% year-over-year.Gross margin of 70.5%, up 5.2% year-over-year. GAAP operating loss of $5.4 million, up $0.1 million, or 2%, year-over-year. GAAP net loss attributable to stockholders of $9.8 million, up $2.6 million, or 35%, year-over-year. Adjusted EBITDA loss of $3.5 million, up $2.2 million, or 155%, year-over-year. The...

Data from pilot trial of AT-007 in SORD deficiency expresses substantial and significant reduction in sorbitol Data from the ACTION-Galactosemia Kids study demonstrates statistically significant reduction in plasma galactitol NEW YORK, Nov. 12, 2021 (GLOBE NEWSWIRE) — Applied Therapeutics, Inc. (Nasdaq: APLT), 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 third quarter ended September 30, 2021. “This quarter we announced positive data in both the Galactosemia pediatric study as well as our pilot SORD Deficiency study, highlighting our execution across programs and expansion into additional indications with AT-007,” said Shoshana Shendelman, PhD, CEO, Founder and Chair...

Quarterly revenue increased 23% to $395.6 million Quarterly IPG Net Earnings decreased 5% to $25.3 million Quarterly adjusted net earnings(1) decreased 5% to $30.0 million Quarterly adjusted EBITDA(1) decreased 2% to $63.0 millionMONTREAL and SARASOTA, Fla., Nov. 12, 2021 (GLOBE NEWSWIRE) — Intertape Polymer Group Inc. (TSX:ITP) (“IPG” or the “Company”) today released results for its third quarter ended September 30, 2021. All amounts in this press release are denominated in US dollars (“USD”) unless otherwise indicated and all percentages are calculated on unrounded numbers. For more information, refer to the Company’s management’s discussion and analysis (“MD&A”) and unaudited interim condensed consolidated financial statements and notes thereto as of and for...

TORONTO and CAMBRIDGE, Mass., Nov. 12, 2021 (GLOBE NEWSWIRE) — ProMIS Neurosciences, Inc. (TSX: PMN) (OTCQB: ARFXF) (“ProMIS or the Company”), a biotechnology company focused on the discovery and development of antibody therapeutics targeting toxic oligomers implicated in the development of neurodegenerative diseases, today announced its operational and financial results for the three and nine months ended September 30, 2021. “We are pleased to be ramping up our efforts to advance our lead asset, PMN 310, closer toward the clinic,” said Gene Williams, ProMIS’ Chairman and CEO. “The financing we secured earlier this year is enabling us to unlock the potential of our platform, which we believe could have significant impact on the treatment of several neurological diseases, including Alzheimer’s Disease (AD), Parkinson’s Disease and...

SOUTH SAN FRANCISCO, Calif., Nov. 12, 2021 (GLOBE NEWSWIRE) — Akero Therapeutics, Inc. (Nasdaq: AKRO), a cardio-metabolic biotechnology company developing transformational treatments for non-alcoholic steatohepatitis (NASH), today reported third quarter financial results for the period ending September 30, 2021. “Our team remains focused on successfully completing two Phase 2b clinical trials, and diligently working with regulators to bring efruxifermin (EFX) to market, potentially as a treatment for patients with more advanced NASH who have the highest medical need,” said Andrew Cheng, M.D., Ph.D., president and chief executive officer of Akero. “We are pleased to have received a Fast Track designation from the FDA, which we believe is a testament to the strength of results we observed in our Phase 2a BALANCED study.” Third Quarter...