Second Quarter Fiscal Year 2023 and Subsequent Highlights: Completed dosing its randomized, double-blind, placebo-controlled Phase 2 trial evaluating ANEB-001's potential in treating acute cannabinoid intoxication ('ACI').
Preliminary data showed that a single 10 mg oral dose of ANEB-001 reduced key symptoms of ACI induced by 30 mg of oral THC.
Final Phase 2 data expected by the end of the first calendar quarter of 2023
End of Phase 2A (EOP2A) meeting with FDA expected second calendar quarter of 2023.
Continued development of an ANEB-001 parenteral formulation
Management Commentary
We completed dosing our Phase 2 in December of last year and remain on-track to present final data before the end of this current calendar quarter, a milestone that enables an EOP2A meeting with FDA to determine the next steps in our development path. We have amassed a significant amount of human clinical data since
Financial Results for the three months ended
Operating expenses in the second quarter of fiscal 2023 were
Net loss in the second quarter of fiscal 2023 was
Cash was
About
About ANEB-001
Our lead product candidate is ANEB-001, a potent, small molecule cannabinoid receptor antagonist, to address the unmet medical need for a specific antidote for ACI. ANEB-001 is an orally bioavailable, readily absorbed treatment candidate that we anticipate will rapidly reverse key symptoms of ACI. ANEB-001 is protected by one issued patent and rights to one patent application covering various methods of use of the compound and delivery systems. We began a Phase 2 proof-of-concept trial for ANEB-001 in
Forward-Looking Statements
Statements contained in this press release that are not statements of historical fact are forward-looking statements as defined in Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. In some cases, these forward-looking statements can be identified by words such as 'anticipate,' 'believe,' 'designed,' 'expect,' 'intend,' 'may,' 'will,' 'should' and other comparable terms. Forward-looking statements include statements regarding Anebulo's intentions, beliefs, projections, outlook, analyses or current expectations regarding: the expected timing for full data from Anebulo's Phase 2 Study of ANEB-001 by the end of the first calendar quarter of 2023; the targeted timing for an End of Phase 2A meeting with the FDA in the first half of calendar 2023; Anebulo's plans to continue developing an ANEB-001 parenteral formulation; future results that may be implied by prior results; Anebulo's belief that the data from its Phase 2 Study of ANEB-001, together with data from its planned observational study in ACI subjects, will provide support for the potential approval of ANEB-001; the potential for ANEB-0001 to address an unmet medical need for a specific antidote for ACI and Anebulo's expectation that ANEB-001 will rapidly reverse key symptoms of ACI. You are cautioned that any such forward-looking statements are not guarantees of future performance and are subject to a number of risks, uncertainties and assumptions, including, but not limited to: initial and interim results from clinical studies are not necessarily indicative of results that may be observed in the future; clinical trial site challenges that may impact the expected timing of the Company's ongoing clinical trials, including challenges related to COVID-19; the timing and success of clinical trials and potential safety and other complications thereof; any negative effects on the Company's business and product development plans caused by or associated with COVID-19 or geopolitical issues and Anebulo's need for additional capital. These and other risks are described under the 'Risk Factors' heading of Anebulo's Quarterly Report on Form 10-Q for the quarter ended
Contact:
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Email: IR@anebulo.com
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