Management believes that the Company’s cash and cash equivalents are sufficient to fund operations and capital requirements into the first quarter of 2024. In the third quarter of 2022, the Company sold and issued 200,000 shares of its common stock under the 2022 Purchase Agreement with LPC in the open market resulting in gross proceeds of $0.2 million and net proceeds of $0.1 million, after deducting offering expenses. On July 21, 2022, the Company entered into a Purchase Agreement and registration rights agreement for up to $20 million with Lincoln Park Capital Fund, LLC (LPC), a Chicago-based institutional investor. In the third quarter of 2022, the Company sold and issued 2,579,346 shares of its common stock under the 2021 Sales Agreement in the open market resulting in gross proceeds of $3.2 million and net proceeds of $3.0 million, after deducting commissions and offering expenses. Inc., as sales agents, pursuant to which the Company may sell, from time to time, up to $75.0 million of its common stock. On May 11, 2021, the Company entered into a Controlled Equity Offering SM Sales Agreement (2021 Sales Agreement), with Cantor Fitzgerald & Co., Canaccord Genuity, LLC, H.C. Net loss for the third quarter of 2022 was $8.7 million, with basic and diluted loss per share of $(0.20).Īs of September 30, 2022, cash and cash equivalents were $55.9 million, compared to $67.8 million as of December 31, 2021. General and administrative expenses were $3.5 million in the third quarter of 2022, including stock-based compensation expense of $0.6 million. Research and development expenses were $5.0 million for the third quarter of 2022, including stock-based compensation of $0.5 million. Zygel was shown to be well tolerated, and the safety profile was consistent with previously released data from other Zygel clinical trials. In addition, the majority of patients showed clinically meaningful improvements as demonstrated by the Clinical Global Impression – Improvement (CGI-I). Statistically significant improvements from baseline were seen in the Pediatric Anxiety Rating Scale (PARS-R), the total score and all five subscales of the Anxiety, Depression and Mood Scale (ADAMS) and all five subscales of the Aberrant Behavior Checklist – Community (ABC-C). These data suggest a positive risk-benefit profile for Zygel in improving anxiety-related and behavioral symptoms in children and adolescents with 22q. The Company presented data at The Society for the Study of Behavioural Phenotypes (SSBP) 24 th International Research Symposium in September 2022 and the 2022 National Organization for Rare Disorders (NORD) Rare Diseases and Orphan Products Breakthrough Summit in October 2022 from the first 14-week treatment period of the Phase 2 INSPIRE trial. In November 2022, the Company announced that the USPTO issued a patent titled “Treatment of 22q11.2 Deletion Syndrome With Cannabidiol,” which includes claims directed to methods of treating one or more behavioral symptoms of 22q with cannabidiol, and expires in 2040. The Company currently plans to initiate a Phase 3 program in children and adolescents with 22q following topline results from RECONNECT. Food and Drug Administration (FDA) before the end of 2022 to obtain feedback on the Phase 2 data and regulatory pathway for Zygel in patients with 22q. ( Press Release)īased on the positive Phase 2 INSPIRE trial data announced in June 2022 ( Press Release), the Company requested and has been granted an initial meeting with the U.S. This new patent, which expires in 2038, is part of an expanding international intellectual property portfolio covering the Company’s transdermal cannabidiol product candidate, Zygel. Patent and Trademark Office (USPTO) issued a patent titled “Treatment of Fragile X Syndrome With Cannabidiol,” which includes claims directed to methods of treating Fragile X syndrome with cannabidiol. In October 2022 the Company announced that the U.S. The Company believes that the results from RECONNECT, if positive, will be sufficient to support the submission of a New Drug Application (NDA) for Zygel in patients with FXS. The Company continues to expect topline results from RECONNECT, a confirmatory pivotal Phase 3 trial of Zygel in patients with FXS, in the second half of 2023. Operational Highlights and Pipeline Update “With a cash runway into the first quarter of 2024, we remain well-positioned on achieving our goal of bringing Zygel to market as the first FDA approved treatment option for the significant unmet medical need that affects FXS patients and their families.” “Enrollment in our confirmatory pivotal Phase 3 RECONNECT trial continues, and we expect topline results in the second half of 2023,” said Armando Anido, Chairman and Chief Executive Officer of Zynerba.
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