Day: November 12, 2021

Interim Management Statement covering Q1 2021/22 The Board of Directors of Rovsing A/S has today considered and approved the Interim Management Statement for the first quarter (1 July 2021 – 30 September 2021) of the financial year 2021/22. Q1 highlightsIn Q1 of the financial year 2021/22, the revenue amounted to DKK 5,6 million (DKK 5,8 million in Q1 2020/21).Q1 EBITDA amounts to DKK 0,1 million (DKK 0,4 million in Q1 2020/21).Rovsing’s Q1 is traditionally a quarter with a lower activity level in our industry due to the summer vacation period.Rovsing’s market situation remains positive, with many new programmes upcoming in the industry both commercially and as well in the institutional segment, with further tenders and prospects expected during the financial year. The order backlog currently amounts to DKK 39 million, covering...

First Patients Dosed in Camsirubicin Phase 1b Clinical Trial in U.S.Validive® Phase 2b/3 VOICE Trial Cleared to Enroll in Europe andon Track for Reaching Interim in H1 2022 WILMETTE, Ill., Nov. 12, 2021 (GLOBE NEWSWIRE) — Monopar Therapeutics Inc. (Monopar or the Company) (Nasdaq: MNPR), a clinical-stage biopharmaceutical company focused on developing proprietary therapeutics designed to extend life or improve the quality of life for cancer patients, today announced third quarter 2021 financial results and summarized recent clinical developments. Recent Clinical Developments ValidiveMonopar received clearance in multiple European countries to conduct its Phase 2b/3 VOICE clinical trial of Validive (clonidine HCl mucobuccal tablet) for the prevention of severe oral mucositis (SOM) in patients undergoing chemoradiotherapy (CRT)...

NEEDHAM, Mass., Nov. 12, 2021 (GLOBE NEWSWIRE) — Candel Therapeutics, Inc. (“Candel” or “the Company”) (Nasdaq: CADL), a late clinical stage biopharmaceutical company developing novel oncolytic viral immunotherapies, today reported financial results for the third quarter ended September 30, 2021 and provided a corporate update. “With the completion of our IPO in August 2021 and multiple data readouts across our product candidates expected over the next 12 months, we are well-capitalized and in a strong position to advance on the Company’s goal to bring novel oncolytic viral immunotherapies to patients with cancer,” said Paul Peter Tak, MD, PhD, FMedSci, President and Chief Executive Officer of Candel Therapeutics. “In the quarter and recent weeks, we expanded visibility of our technology and clinical programs with six presentations...

– 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...