Exhibit 99.1
Anebulo Pharmaceuticals Reports Fourth Quarter and Fiscal Year 2024
Financial Results and Recent Updates
AUSTIN, Texas (September 25, 2024) – Anebulo Pharmaceuticals, Inc. (Nasdaq: ANEB), a clinical-stage biopharmaceutical company developing novel solutions for people suffering from acute cannabis-induced toxic effects (the “Company” or “Anebulo”), today announced financial results for the three and twelve months ended June 30, 2024, and recent updates.
Fourth Quarter Fiscal Year 2024 and Subsequent Highlights:
● | Anebulo announced it has been awarded the first tranche of a two year cooperative grant of up to approximately $1.9 million from the National Institute on Drug Abuse (“NIDA”), part of the National Institutes of Health (“NIH”) | |
● | With
the support of NIDA, Anebulo aims to complete IND-enabling activities and the scale up of its intravenous | |
● | Anebulo prioritizes development of selonabant IV formulation for unintentional cannabis poisoning in children in response to the growing medical need and impending change in Drug Enforcement Agency scheduling of marijuana from a Schedule I to a Schedule III controlled substance supported by the United States Department of Justice |
“The
recently awarded grant from NIDA further enables our efforts to provide a rapid and clinically impactful emergency treatment for acute
cannabis-induced toxicities, including cannabis-induced Central Nervous System
“We believe this important grant from NIDA recognizes the progress we have already made with the successful Phase 2 proof of concept study of oral selonabant and provides further momentum for advancing the intravenous formulation towards clinical testing. We also believe this awarded grant further validates the significant and growing unmet medical need for an emergency antidote to cannabis toxicity. In particular, acute cannabis exposure in children is a serious and potentially life-threatening condition that can result in CNS depression, respiratory depression, coma, and in rare cases death. Research has shown that children are much more sensitive to the toxic effects of cannabis, due in part to age-related differences in the abundance of cannabis receptors in their brains. As a direct consequence, pediatric cannabis ingestion can result in much more serious outcomes than in adults, and a much greater risk of hospitalization and admission to intensive care. If approved, we believe selonabant has the potential to offer a much-needed targeted therapy for rapidly reversing the serious and life-threatening consequences of accidental cannabis ingestion in children.”
Financial Results for the three months ended June 30, 2024
● | Operating expenses in the fourth quarter of fiscal 2024 were $1.3 million compared with $2.5 million in the same period in fiscal 2023. | |
● | Net loss in the fourth quarter of fiscal 2024 was $1.3 million, or $(0.05) per share, compared with a net loss of $2.5 million, or $(0.10) per share, in the fourth quarter of fiscal 2023. Cash and cash equivalents were $3.1 million as of June 30, 2024. | |
● | The Company has access to an additional $10 million in cash through the Loan and Security Agreement executed on November 13, 2023. |
Financial Results for the twelve months ended June 30, 2024
● | Operating expenses in fiscal year 2024 were $8.3 million compared with $11.8 million in the same period in fiscal 2023. Research and Development expenses decreased approximately $2.1 million from the prior year, primarily due to the completion of the Company’s Phase 2 proof of concept clinical trial for acute cannabinoid intoxication (“ACI”) during the first half of the fiscal year ended June 30, 2024, and prioritizing the advancement of a selonabant IV formulation, which resulted in a reduction in activities related to pre-clinical, clinical studies, and direct third-party costs. General and Administrative expenses decreased $1.4 million from the prior period, primarily due to an overall reduction in compensation and related benefits, including stock-based compensation, professional and consultant fees, and a decrease in directors’ and officer’s insurance premiums. | |
● | Net loss in fiscal year 2024 was $8.2 million, or $(0.32) per share, compared with a net loss of $11.7 million, or $(0.47) per share, in fiscal year 2023. The decrease in the net loss and resulting net loss per share was the result of decreased operating expenses as discussed above. |
About Selonabant (ANEB-001)
The
Company’s lead product candidate is selonabant (ANEB-001), a potent, small molecule antagonist of
About Anebulo Pharmaceuticals, Inc.
Anebulo
Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company developing novel solutions for people suffering from acute cannabinoid
intoxication and unintentional cannabis intoxication. Its lead product candidate, selonabant, has completed dosing in a Phase 2 clinical
trial (www.clinicaltrials.gov/ct2/show/NCT05282797) evaluating its utility in blocking and reversing the negative effects of acute
cannabinoid intoxication. Rather than proceeding directly with the Phase 3 studies of oral selonabant in adults with ACI,
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,” “designed,” “expect,” “may,”
“will,” “should” and other comparable terms. Forward-looking statements include statements regarding Anebulo’s
intentions, beliefs, projections, outlook, analyses or current expectations regarding: completion of IND-enabling activities and the
scale up of Anebulo’s intravenous formulation of selonabant around year end 2024 as Anebulo prepares for clinical studies; enrollment
of the first
CONTACTS:
Anebulo Pharmaceuticals, Inc.
Daniel George
Part time Chief Financial Officer
(512) 598-0931
Dan@anebulo.com
Condensed Balance Sheets
June 30, | ||||||||
2024 | 2023 | |||||||
Cash and cash equivalents | $ | 3,094,200 | $ | 11,247,403 | ||||
Total assets | 4,073,114 | 11,670,151 | ||||||
Total liabilities | 260,583 | 1,068,801 | ||||||
Total stockholders’ equity | 3,812,531 | 10,601,350 |
Condensed Statements of Operations
Three months ended June 30, | Year ended June 30, | |||||||||||||||
2024 | 2023 | 2024 | 2023 | |||||||||||||
Research and development | $ | 467,706 | $ | 1,417,159 | $ | 3,548,937 | $ | 5,600,197 | ||||||||
General and administrative | 872,661 | 1,077,230 | 4,759,818 | 6,183,402 | ||||||||||||
Total operating expenses | 1,340,367 | 2,494,389 | 8,308,755 | 11,783,599 | ||||||||||||
Loss from operations | (1,340,367 | ) | (2,494,389 | ) | (8,308,755 | ) | (11,783,599 | ) | ||||||||
Other (income) expenses: | ||||||||||||||||
Interest expense | 59,696 | - | 151,230 | - | ||||||||||||
Interest income | (50,218 | ) | (6 | ) | (249,022 | ) | (92,407 | ) | ||||||||
Other | 124 | 1,197 | (9,260 | ) | 41,146 | |||||||||||
Total other (income) expenses, net | 9,602 | 1,191 | (107,052 | ) | (51,261 | ) | ||||||||||
Net loss | $ | (1,349,969 | ) | $ | (2,495,580 | ) | $ | (8,201,703 | ) | $ | (11,732,338 | ) | ||||
Weighted average common shares outstanding, basic and diluted | 25,933,217 | 25,633,217 | 25,822,258 | 25,074,481 | ||||||||||||
Net loss per share, basic and diluted | $ | (0.05 | ) | $ | (0.10 | ) | $ | (0.32 | ) | $ | (0.47 | ) |