Month: March 2022

Two ongoing Phase 1 trials of unmodified placental-derived natural killer cell therapy candidate, CYNK-001, in acute myeloid leukemia (AML) and glioblastoma multiforme (GBM) An ongoing Phase 1 portion of a Phase 1/2a trial of genetically modified placental-derived natural killer cell therapy candidate, CYNK-101, in HER2+ gastric cancer All three ongoing clinical programs have been granted Fast Track designation by the U.S. Food and Drug Administration (FDA) CYNK-001 granted Orphan Drug Designation by the FDA for treatment of malignant gliomas, including GBM and CYNK-101 granted Orphan Drug Designation for treatment of HER2+ gastric cancer Announced three partnerships to expand the potential opportunities for placental-derived cell therapy in additional indications, including combination therapies and new therapeutic areas FLORHAM PARK,...

Provides update on ongoing FDA review of Tebipenem HBr NDA Phase 2 trial of SPR720 in nontuberculous mycobacterial-pulmonary disease on track for initiation in 2H 2022 following lifting of FDA clinical hold Topline results from Phase 1 bronchoalveolar lavage trial support further development of SPR206 in the setting of hospital-acquired pneumonia and ventilator-associated pneumonia Conference call and live webcast at 4:30 p.m. ET today CAMBRIDGE, Mass., March 31, 2022 (GLOBE NEWSWIRE) — Spero Therapeutics, Inc. (Nasdaq: SPRO) today announced financial results for the fourth quarter and full-year ended December 31, 2021 and provided a business update. The U.S. Food and Drug Administration (FDA) has notified Spero that, as part of its ongoing review of Spero’s New Drug Application (NDA) for tebipenem HBr, it has identified deficiencies...

REDWOOD CITY, Calif., March 31, 2022 (GLOBE NEWSWIRE) — Soleno Therapeutics, Inc. (Soleno) (NASDAQ: SLNO), a clinical-stage biopharmaceutical company developing novel therapeutics for the treatment of rare diseases, today provided a corporate update and announced financial results for the fourth quarter and full-year ended December 31, 2021. Fourth Quarter 2021 and Recent Corporate HighlightsReceived official meeting minutes on January 20, 2022, from the December 21, 2021, Type C meeting with the U.S. Food and Drug Administration’s (FDA) Division of Psychiatry. The purpose of the meeting was to discuss the adequacy of the data submitted to the FDA by Soleno in October 2021 to support a potential New Drug Application (NDA) submission for diazoxide choline extended-release (DCCR) tablets for the treatment of Prader-Willi syndrome...

~ Corporate Update Call to be Held Wednesday, April 6, 2022 ~ SAN DIEGO, March 31, 2022 (GLOBE NEWSWIRE) — Ensysce Biosciences, Inc. (“Ensysce” or the “Company”) (NASDAQ: ENSC, OTC: ENSCW), a clinical-stage biotech company applying transformative chemistry to improve prescription drug safety and performance with a current focus on reducing abuse and overdose, today reported financial results for the fourth quarter and full year 2021. Dr. Lynn Kirkpatrick, Chief Executive Officer of Ensysce, commented, “Following the successful completion of our convertible note financing of $15 million, providing the necessary funds to advance our clinical trials, the year concluded with an exceptional Company milestone as the first patients were enrolled in the Phase 1 study of PF614-MPAR™, the first product utilizing our MPAR™ platform designed...

– Global Phase 3 Trial of CBP-201 in Moderate-to-Severe Atopic Dermatitis Expected to Commence in H2 2022 –– Topline Phase 2 CBP-307 Results in Moderate-to-Severe Ulcerative Colitis Expected to Be Reported in H1 2022 –– Cash Balance of RMB 1,706.9 million (USD 267.7 million) at December 31, 2021 – SAN DIEGO, CA and TAICANG, SUZHOU, China, March 31, 2022 (GLOBE NEWSWIRE) — Connect Biopharma Holdings Limited (Nasdaq: CNTB) (“Connect Biopharma” or the “Company”), a global, clinical-stage biopharmaceutical company dedicated to improving the lives of patients with inflammatory diseases through the development of therapies derived from T cell-driven research, today announced financial results for the full year ended December 31, 2021 and recent corporate highlights. “During the past year, we advanced...

IRVING, Texas, March 31, 2022 (GLOBE NEWSWIRE) — AgileThought, Inc. (“AgileThought” or the “Company”) (NASDAQ: AGIL), a global provider of digital transformation services, custom software development, and next generation technologies, today reported results for the fourth quarter and full year ended December 31, 2021. Fourth Quarter 2021 Highlights and Results:Revenue was $42.1 million, a 22.0% increase over Q4 2020 revenue of $34.5 million and a 4.2% increase over Q3 2021 Gross profit was $12.5 million, a 40.4% increase over Q4 2020 gross profit of $8.9 million, and a 16.2% increase over Q3 2021 9 new clients added during the quarter $53 million in bookings (Total Contract Value) 1.3x Book to Bill ratio in Q4 2021 (Total Contract Value/Revenue)2021 Full Year Highlights and Results:Revenue was $158.7 million for 2021, a 3.2%...

Second Quarter Fiscal 2022 revenue grew 22% year-over-year SaaS Annual Recurring Revenue grew 28% year-over-yearBOSTON, March 31, 2022 (GLOBE NEWSWIRE) — Duck Creek Technologies (NASDAQ: DCT), a provider of SaaS-delivered enterprise software to the property & casualty (“P&C”) insurance industry, today announced its financial results for the three and six months ended February 28, 2022. “Duck Creek’s second quarter results reflected continued adoption of Duck Creek OnDemand by customers across all tiers.  New and existing customer interest on moving their critical core systems to the cloud remains very strong and is viewed as essential to their success,” said Michael Jackowski, Duck Creek’s Chief Executive Officer.                                                                               Mr. Jackowski added, “As...

Conference Call and Webcast to be held at 8:00 AM ET on Friday, April 1, 2022 BRANFORD, Conn., March 31, 2022 (GLOBE NEWSWIRE) — Sachem Capital Corp. (NYSE American: SACH) announces its financial results for the year ended December 31, 2021. The company will host a conference call on Friday, April 1, 2022 at 8:00 a.m. Eastern Time to discuss in greater detail its financial condition and operating results for the year ended December 31, 2021, as well as its outlook for 2022. John Villano, CPA, the company’s Chief Executive and Chief Financial Officer stated: “We continued to generate solid year-over-year revenue growth and achieved record net income attributable to common shareholders of $11.5 million, or $0.44 per share, for 2021. We believe these results illustrate the success and scalability of our business model. Heading into...

Reported positive data from Phase 1b trials of batiraxcept in clear cell renal cell carcinoma and pancreatic adenocarcinoma in 1Q’22; on track to report updated data in 2Q’22 Dosed first patient in Phase 2 trial of batiraxcept in ccRCC in January 2022; on track to report preliminary data in 2Q’22 Additional biomarker data from Phase 1b ccRCC trial anticipated in 2Q’22 Strengthened balance sheet with $20 million investment by Eshelman Ventures, LLC and a healthcare-focused institutional investor in 1Q’22 providing anticipated cash runway into 1Q’23; Appointed Fred Eshelman, Pharm.D., Executive Chairman of Aravive Board of DirectorsHOUSTON, March 31, 2022 (GLOBE NEWSWIRE) — Aravive, Inc. (Nasdaq: ARAV, “the Company”), a late clinical-stage oncology company developing targeted therapeutics to treat metastatic disease, today announced...

SAN DIEGO, March 31, 2022 (GLOBE NEWSWIRE) — CV Sciences, Inc. (OTCQB:CVSI) (the “Company”, “CV Sciences”, “our”, “us” or “we”), a preeminent supplier and manufacturer of hemp cannabidiol (CBD) products, today announced its financial results for the year ended December 31, 2021. Fiscal 2021 and Recent Financial and Operating HighlightsRevenue of $20.0 million for fiscal year 2021, compared to $24.4 million for 2020; Gross margin of 43.0% for fiscal year 2021, compared to 45.1% for 2020; Total cash balance of $1.4 million at year end, compared to $4.5 million at the end of 2020; Total retail distribution of more than 8,400 stores as of December 31, 2021, an increase from 7,300 stores as of December 31, 2020; Launched ProCBD™, a full product line of clinical strength products supported by clinical research and available exclusively...