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Clarus Therapeutics Holdings, Inc. (OTC: CRXTQ) announced the conclusion of a court-supervised auction for its product JATENZO (testosterone undecanoate capsules). The auction, held on October 14, 2022, resulted in Tolmar, Inc. being selected as the winning bidder, pending final approval from the U.S. Bankruptcy Court on October 26, 2022. The asset sale is part of Clarus’ ongoing Chapter 11 proceedings, initiated in Delaware. Stakeholders can access further details through Clarus' claims agent, Stretto.
Clarus Therapeutics Holdings has filed for Chapter 11 bankruptcy, seeking to auction its primary asset, JATENZO, a testosterone treatment. The company aims to maintain operations during this process and believes it has enough financial resources to meet obligations. Clarus’s leadership expressed that a structured sale is necessary due to financial challenges, despite JATENZO's potential market value. Interested buyers can bid on the assets through a court-approved process, which is expected to conclude by late October 2022.
Clarus Therapeutics Holdings reported a 46% year-over-year increase in net revenue for Q2 2022, reaching $4.1 million. Prescription growth for JATENZO surged 72% year-over-year. However, the company announced a 40% workforce reduction to evaluate strategic alternatives, impacting their operational structure. Clarus faced a net loss of $10.7 million for the quarter, raising concerns about its ability to continue as a going concern. Cash reserves stood at $19.2 million as of June 30, 2022, with significant debt.
Clarus Therapeutics Holdings, Inc. (Nasdaq:CRXT) announced a notice of allowance from the USPTO for additional patent claims covering its oral testosterone replacement therapy, JATENZO (testosterone undecanoate). This patent, set to expire in 2030, will be the ninth patent for JATENZO listed in the FDA’s Orange Book. Dr. Robert Dudley, CEO, highlighted the strategic investment in JATENZO's intellectual property. Male hypogonadism affects an estimated 20 million men in the U.S., with JATENZO providing a treatment option for this condition.
Oragenics, Inc. (NYSE American: OGEN) has appointed Kimberly M. Murphy as President and CEO effective June 23, 2022. Murphy, a seasoned vaccine industry leader with over 25 years of experience, has previously held significant roles at companies like Merck and GSK. Her appointment is expected to enhance Oragenics' strategic vision and accelerate growth, particularly in their ongoing vaccine development efforts against infectious diseases, including COVID-19. As a board member since 2020, her insights have already contributed to the company’s strategies.
Clarus Therapeutics Holdings, Inc. (Nasdaq: CRXT) will present new data for JATENZO (testosterone undecanoate) at ENDO 2022, the Endocrine Society’s annual meeting, scheduled for June 11-14, 2022, in Atlanta. The presentation, titled Comparison Between Single Time Point Testing and 24-Hour Average Concentration of Total Testosterone, is set for June 13, 2022. JATENZO is the first FDA-approved oral softgel for testosterone replacement therapy in men with deficient testosterone levels due to medical conditions, potentially affecting 20 million men in the U.S.
Clarus Therapeutics announced the issuance of a new patent for JATENZO, its oral testosterone replacement therapy, by the USPTO. Patent No. 11,331,325 enhances the company’s intellectual property portfolio, now totaling eight patents listed in the FDA's Orange Book, with the latest patent expiring in January 2027. JATENZO addresses male hypogonadism, a condition affecting approximately 20 million men in the U.S. This development supports Clarus' strategy to protect and expand market opportunities for JATENZO.
Clarus Therapeutics (Nasdaq: CRXT) reported a 72% increase in net revenue for Q1 2022, totaling $4.0 million compared to $2.3 million last year. Total prescriptions for JATENZO® rose by 12% sequentially and 75% year-over-year. The company closed a $30 million public offering, extending its cash runway. Operating expenses increased by 33% to $16.9 million, while the net loss was $14.9 million, or $0.61 per share. Major clinical trials for JATENZO and CLAR-121 are anticipated in the second half of 2022.
Clarus Therapeutics Holdings (Nasdaq: CRXT) announced it will release its Q1 2022 financial results on May 16, 2022, after market close. A conference call is scheduled for the same day at 5:15 p.m. ET, where investors can discuss the results. Domestic callers can dial (844) 249-2007 and international callers can use (224) 619-3902, using conference ID 7677008. Clarus specializes in androgen and metabolic therapies, with its first product being JATENZO® (testosterone undecanoate). More details can be found on their investor website.
Clarus Therapeutics Holdings announced a notice of allowance from the USPTO for its patent on CLAR-121, a treatment for autoimmune inflammatory mastitis. The U.S. patent is set to expire in June 2040. The company aims to obtain Orphan Drug Designation from the FDA for CLAR-121, focusing on periductal mastitis (PDM), affecting around 150,000 women in the U.S. annually. Clarus plans to initiate a Phase 2 clinical trial in the second half of 2022, pending funding. The patent supports a novel approach to treating this painful condition without effective drug interventions.
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