Month: March 2024

Following FDA Clearance of FemaSeed®, Company Secures Capital to Support Commercial Initiatives; Cash Expected to Fund Operations Into 2H 2025 ATLANTA, March 28, 2024 (GLOBE NEWSWIRE) — Femasys Inc. (NASDAQ: FEMY), a leading biomedical company focused on addressing significant unmet needs of women worldwide with a broad portfolio of in-office, accessible and innovative therapeutic and diagnostic products, announces financial results for the year ended December 31, 2023 and provides a corporate update. Corporate Highlights from 4Q 2023 to dateCompany announced positive topline data from pivotal trial for FDA-cleared FemaSeed® for the treatment of infertility Following FDA clearance of FemaSeed, the Company’s revolutionary approach to artificial insemination, Femasys announced completion of enrollment in pivotal trial in support...

Reported positive Phase 1/2 proof-of-concept data for lonigutamab, first subcutaneous anti-IGF-1R to demonstrate clinical responses in thyroid eye disease patients Achieved primary endpoint with high statistical significance in global Phase 2b/3 clinical trial of izokibep in psoriatic arthritis with robust clinical responses also achieved for higher hurdle endpoints Announced differentiated long-term 32-week data from global Phase 2b clinical trial of izokibep in hidradenitis suppurativa – ongoing Phase 3 trial is enrolling faster than previously expected and topline data now expected in second half of 2024 Cash, cash equivalents and short-term marketable securities of $721.3 million provides runway to support key late-stage data milestones including registrational studies for multiple indications LOS ANGELES, March 28, 2024 (GLOBE...

Company to Host Conference Call Today, March 28, at 4:30pm ET BOCA RATON, Fla., March 28, 2024 (GLOBE NEWSWIRE) — INmune Bio Inc. (NASDAQ: INMB) (the “Company”), a clinical-stage immunology company focused on developing treatments that harness the patient’s innate immune system to fight disease, today announces its financial results for the year ended December 31, 2023 and provides a business update. Q4 2023 and Recent Corporate Highlights   DN-TNF Platform Highlights (XPro™):The AD02 randomized, blinded program for patients with Early Alzheimer’s Disease remains on schedule to reach its final enrollment target by mid-2024, with top-line data expected to be presented approximately six months after the last patient is enrolled. The trial is currently active in North America, UK, EU, and the Pacific Rim. INmune Bio...

Company to host conference call at 4:30 PM EDT today, Thursday, March 28, 2024 SEATTLE and VANCOUVER, British Columbia, March 28, 2024 (GLOBE NEWSWIRE) — Achieve Life Sciences, Inc. (NASDAQ: ACHV), a late-stage pharmaceutical company committed to the global development and commercialization of cytisinicline for smoking cessation and nicotine dependence, today announced fourth quarter and year-end 2023 financial results and provided an update on the cytisinicline development program. Recent HighlightsAnnounced Company reached agreement with the U.S. Food and Drug Administration (FDA) on long-term cytisinicline exposure requirements to support a New Drug Application (NDA) submission Completed an equity financing of up to $124.2 million that included initial upfront gross proceeds of $60.0 million, prior to deducting placement agent...

SCY-247’s IND-enabling activities continue to advance with initiation of Phase I anticipated in the second half of 2024Data analysis for the FURI study is ongoing; top line data from the CARES study has been received and is positive and consistent with previously disclosed results from interim analysesThe clinical study reports for FURI, CARES and NATURE in refractory invasive fungal infections are on target for delivery to GSK in the first half of 2024 which would trigger a $10 million development milestone payment to SCYNEXISSCYNEXIS ended 2023 with cash, cash equivalents and investments of $98.0 million and projects a cash runway of more than two yearsJERSEY CITY, N.J., March 28, 2024 (GLOBE NEWSWIRE) — SCYNEXIS, Inc. (NASDAQ: SCYX), a biotechnology company pioneering innovative medicines to overcome and prevent...

Orlando, Fla., March 28, 2024 (GLOBE NEWSWIRE) — CNL Strategic Capital, LLC (“CNL Strategic Capital,” the “Company” or “we”) seeks to provide current income and long-term appreciation to investors by acquiring controlling equity stakes in combination with loan positions in privately owned middle-market businesses. The Company announced its operating results for the year ended Dec. 31, 2023. Highlights:As of Dec. 31, 2023, CNL Strategic Capital’s portfolio consisted of equity and debt investments in 13 portfolio companies and approximately $1.0 billion in total assets, compared with approximately $732.5 million as of Dec. 31, 2022. For the year ended Dec. 31, 2023, the Company recognized a net change in unrealized appreciation on investments of approximately $41.7 million and had total investment income of approximately $59.5...