Year: 2021

– Full clinical trial results from Phase 1a trial of PRA023 and announcement of a third Phase 2 indication for PRA023 expected in fourth quarter 2021 – – Enrollment on track for Phase 2 in ulcerative colitis and Phase 2a in Crohn’s disease with topline data from both trials anticipated by fourth quarter 2022 – – Enrolled over 1,500 patients in the Prometheus Enroll360TM platform to support future studies – – Strong cash position of $279 million as of September 30, 2021- SAN DIEGO, Nov. 12, 2021 (GLOBE NEWSWIRE) — Prometheus Biosciences, Inc. (Nasdaq: RXDX), a clinical-stage biotechnology company pioneering a precision medicine approach for the discovery, development, and commercialization of novel therapeutic and companion diagnostic products for the treatment of immune-mediated diseases,...

Dosed first healthy volunteers in Phase 1 clinical trial of oral IL-17 antagonist S011806 Successfully completed $234.6 million upsized initial public offeringSOUTH SAN FRANCISCO, Calif., Nov. 12, 2021 (GLOBE NEWSWIRE) — DICE Therapeutics, Inc. (Nasdaq: DICE), a biopharmaceutical company leveraging its proprietary technology platform to build a pipeline of novel oral therapeutic candidates to treat chronic diseases in immunology and other therapeutic areas, today reported financial results and business highlights for the third quarter ended September 30, 2021. “The third quarter represented a pivotal time for DICE both clinically and operationally as we transitioned into a clinical-stage, public company,” said Kevin Judice, Ph.D., CEO of DICE Therapeutics. “We recently dosed the first volunteers in our ongoing Phase 1 clinical...

Cash and investments of $936.4 million as of September 30, 2021 supports advancing multi-modality cell therapy pipelineSOUTH SAN FRANCISCO, Calif., Nov. 12, 2021 (GLOBE NEWSWIRE) — Lyell Immunopharma, Inc. (Lyell), (Nasdaq: LYEL), a T cell reprogramming company dedicated to the mastery of T cells to cure patients with solid tumors, today reported third quarter 2021 financial results and provided business highlights. “We continue to advance our multi-modality pipeline and remain on track to submit four INDs by the end of 2022 and are expanding our organizational capabilities across research, development and manufacturing to support our pipeline.” said Liz Homans, Chief Executive Officer of Lyell. “Our team is preparing to initiate multiple clinical trials incorporating our two platforms that enable T cells to overcome exhaustion...

Omaha, Nov. 12, 2021 (GLOBE NEWSWIRE) — FitLife Brands Announces Third Quarter 2021 Results OMAHA, NE – November 12, 2021 — FitLife Brands, Inc. (“FitLife” or the “Company”) (OTCQX: FTLF), an international provider of innovative and proprietary nutritional supplements for health-conscious consumers marketed under the brand names NDS Nutrition, PMD, SirenLabs, Nutrology, CoreActive, Metis Nutrition, iSatori, Energize, and BioGenetic Laboratories, today announced results for the three and nine months ended September 30, 2021. Highlights for the third quarter ended September 30, 2021 include:Total revenue decreased 3% to $6.7 million. Online revenue increased 40% to $1.7 million and accounted for 25% of total revenue. Wholesale revenue declined 12% driven by higher-than-normal purchases by GNC during the third quarter of 2020...

Reported approximately 40% increase in revenue compared to Q2 2021On track to file a 510(k) submission to FDA by end of 2021 for Pure-Vu EVS, an advanced, next-generation system that will enhance procedural ease of use and speed of deploymentDesigning a multi-center, randomized controlled trial to support reimbursement of Pure-Vu for high need outpatients, a subset of the US market of more than 20 million total annual colonoscopiesFORT LAUDERDALE, Fla., Nov. 12, 2021 (GLOBE NEWSWIRE) — Motus GI Holdings, Inc., (NASDAQ: MOTS) (“Motus GI” or the “Company”), a medical technology company providing endoscopy solutions that improve clinical outcomes and enhance the cost-efficiency associated with the diagnosis and management of gastrointestinal conditions, today reported its financial results for the third...

Longeveron to hold conference call today at 8:30 AM EST MIAMI, Nov. 12, 2021 (GLOBE NEWSWIRE) — Longeveron Inc. (NASDAQ: LGVN) (“Longeveron” or “Company”), a clinical stage biotechnology company developing cellular therapies for chronic aging-related and life-threatening conditions, today provided a business update regarding the status of the Company’s various clinical research programs and reported its financial results for the quarter ended September 30, 2021. “In the third quarter of 2021, we continued executing across our pipeline,” said Geoff Green, CEO of Longeveron. “With a growing base of encouraging clinical data, we continue to make excellent progress in advancing our lead candidate, Lomecel-B, into next phase trials. In addition to the ongoing Phase 1 and 2 trials in flu and COVID-related Acute...

Advancing Phase 1b study of VIP152 in MYC-driven relapsed or refractory aggressive lymphomas and advanced solid tumors Phase 1b dose escalation study of VIP152 in patients with CLL relapsed/refractory to venetoclax and BTK inhibitors on track to initiate in 2H2021 Strengthened balance sheet with $50M private placement PALO ALTO, Calif., Nov. 12, 2021 (GLOBE NEWSWIRE) —  Vincerx Pharma, Inc. (Nasdaq: VINC), a biopharmaceutical company aspiring to address the unmet medical needs of patients with cancer through paradigm-shifting therapeutics, today reported financial results for the third quarter ended September 30, 2021 and provided a corporate update. “Our Phase 1b study of VIP152 continues to enroll across diverse indications per our development plan. Despite the recent COVID surge, we remain on-track with our goal to initiate...

PRT543 and PRT811 Demonstrate Favorable Safety Profile, Tolerability and Evidence of Preliminary Clinical Activity in Phase 1 Dose Escalation in Unselected Patients Phase 1 Dose Expansion Ongoing in Biomarker-Selected Solid Tumor and Hematologic Malignancy Expansion Cohorts for PRT543; Dose Expansion Portion of Phase 1 Trial of PRT811 to Commence 4Q21 with Data Readouts Anticipated for Both Programs in 2022 PRT2527 IND Cleared by FDA; Phase 1 Clinical Trial Evaluating IV Monotherapy in Patients with Selected Solid Tumors Anticipated to Begin by Year-End Strong Cash, Cash Equivalents and Marketable Securities Position of $320 Million to Support Clinical and Discovery Pipeline Advancement WILMINGTON, Del., Nov. 12, 2021 (GLOBE NEWSWIRE) — Prelude Therapeutics Inc. (Nasdaq: PRLD), a clinical-stage precision oncology company, today...

Reports early patient mortality data in Tigris Trial on target with expectations TORONTO, Nov. 12, 2021 (GLOBE NEWSWIRE) — Spectral Medical Inc. (“Spectral” or the “Company”) (TSX: EDT), a late stage theranostic company advancing therapeutic options for sepsis and septic shock, as well as commercializing a new proprietary platform targeting the renal replacement therapy market through its wholly-owned subsidiary Dialco Medical Inc. (Dialco), today announced its financial results for the third quarter ended September 30, 2021, and provided a corporate update. Chris Seto, CEO of Spectral, commented, “We are pleased to report progress on the clinical development of Toraymyxin™ (“PMX”), though the direct impact of covid outbreaks continue to correlate to decreased enrollment. As we entered Q3 2021, enrollment activity ramped up significantly...

Continues to progress Phase 1b randomized, double-blind, placebo-controlled trial of ALRN-6924 in patients with p53-mutated non-small cell lung cancer (NSCLC) undergoing chemotherapyUpdated planned NSCLC study data readouts include interim results in 2Q22; topline full results in 4Q22  Reported preliminary data on ALRN-6924’s p21-mediated cell cycle arrest in healthy humansConfirmed biomarker-driven mechanism of action Characterized time to onset, magnitude and duration of cell cycle arrest, informing potential universal dose and schedule across distinct chemotherapy regimens        $52.2 million cash and cash equivalents as of September 30, 2021, expected to fund operations into second half of 2023BOSTON, Nov. 12, 2021 (GLOBE NEWSWIRE) — Aileron Therapeutics (NASDAQ:ALRN), a chemoprotection oncology company focused...