Jamaican Vomiting Sickness

AUSTIN, Texas--(BUSINESS WIRE)-- Anebulo Pharmaceuticals, Inc. (Nasdaq: ANEB), a clinical-stage biopharmaceutical company developing novel solutions for people suffering from acute cannabinoid intoxication (ACI) and substance abuse (the “Company” or “Anebulo”), today announced financial results for the three months ended December 31, 2023, and recent updates. Second Quarter Fiscal Year 2024 and Subsequent Highlights: Richie Cunningham announced as Chief Executive Officer United States Adopted Names (USAN) adopted selonabant as the generic name for ANEB-001 Advancing selonabant IV formulation as a second product Secured a credit facility of up to $10 million Bimal Shah announced as Board Member “Anebulo continues to make progress towards our goal of becoming the first company to have an approved treatment for acute cannabinoid intoxication. Our current efforts are focused on completion of critical steps needed to support the future Phase 3 studies of selonabant, including efficient scale up of manufacturing, completion of remaining nonclinical activities, and finalizing the designs of our proposed registrational studies for further discussion with the FDA. One important development at Anebulo is the advancement of a selonabant IV formulation, which we are currently scaling-up for initial clinical safety studies as a potential treatment for patients where oral dosing is not an option, such as younger pediatric patients accidentally exposed to cannabis, who may experience serious outcomes like CNS depression, seizures, or coma,” commented Richie Cunningham, Chief Executive Officer of Anebulo. “We find ourselves at a seminal moment to deliver a meaningfully constructive solution to healthcare providers and to their patients suffering with ACI and associated cannabis toxicities,” Cunningham continued. “Despite the high tolerability of cannabis in the majority of users, a significant number of users who develop ACI may experience moderate to severe neuropsychiatric symptoms such as anxiety, paranoia, and psychosis. In addition to poor patient outcomes, cannabis toxicity places a substantial burden on the healthcare system. “We are pleased to report that the USAN Council has adopted selonabant as the generic name for ANEB-001. This is just another step in the journey to delivering a much needed solution to patients. “Lastly, the company has recently strengthened its capital structure by executing a credit facility with certain existing investors that will allow us access of up to $10 million. This facility reflects their on-going confidence and support as we continue to prepare for Phase 3 trials, a very important step in our mission.” Financial Results for the three months ended December 31, 2023 Operating expenses in the second quarter of fiscal 2024 were $2.8 million compared with $3.8 million in the same period in fiscal 2023. Net loss in the second quarter of fiscal 2024 was $2.7 million, or $(0.11) per share, compared with a net loss of $3.8 million, or $(0.15) per share, in the second quarter of fiscal 2023. Cash was $6.6 million as of December 31, 2023. About Selonabant (ANEB-001) Our lead product candidate is selonabant (ANEB-001), a potent, small molecule antagonist of cannabinoid receptor type 1 (CB1), under development to address the unmet medical need for a specific antidote for cannabis toxicity, including ACI. Selonabant is an orally bioavailable, readily absorbed treatment candidate that we anticipate will rapidly reverse key symptoms of ACI. Selonabant is protected by two issued patents and rights to four pending patent applications covering various methods of use of the compound and delivery systems. We are targeting initiation of Phase 3 registrational studies of oral selonabant in the first half of calendar 2024. In addition, an observational study in patients presenting to Emergency Departments with ACI is currently ongoing. The study will determine concentrations of cannabinoids and metabolites in plasma and gather information on signs and symptoms, patients’ disposition and selected subjective assessments. About Anebulo Pharmaceuticals, Inc. Anebulo Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company developing novel solutions for people suffering from acute cannabinoid intoxication and, longer term, for substance use disorders. Its lead product candidate, selonabant, has completed dosing in a Phase 2 clinical trial ( ) evaluating its utility in blocking and reversing the negative effects of acute cannabinoid intoxication. Selonabant is a competitive antagonist at the human cannabinoid receptor type 1 (CB1). For further information about Anebulo, please visit . 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: the targeted commencement of phase 3 registrational trials for selonabant in the first half of calendar 2024; the advancement of a selonabant IV formulation; the observational study of selonabant; pending patent applications; the potential for selonabant to address an unmet medical need for a specific antidote for ACI; Anebulo becoming the first company to have an approved treatment for ACI; and Anebulo's expectation that selonabant will rapidly reverse key symptoms of ACI or related cannabis toxicities . 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; the ability to obtain regulatory approval; the timing and success of development efforts and clinical trials may be impacted by various factors, including safety and other complications; any negative effects on the Company's business and product development plans caused by or associated with health crises 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 September 30, 2023, as filed with the SEC on November 14, 2023, and in Anebulo's Quarterly Report on Form 10-Q for the quarter ended December 31, 2023, being filed with the SEC on February 13, 2024. All forward-looking statements made in this press release speak only as of the date of this press release and are based on management's assumptions and estimates as of such date. Except as required by law, Anebulo undertakes no obligation to update or revise forward-looking statements to reflect new information, future events, changed conditions or otherwise after the date of this press release. Condensed Balance Sheets December 31, June 30, 2023 2023 Cash $ 6,644,517 $ 11,247,403 Total assets 7,500,773 11,670,151 Total liabilities 1,013,556 1,068,801 Total stockholders’ equity 6,487,217 10,601,350 Condensed Statements of Operations Three Months Ended December 31, 2023 2022 Research and development $ 1,062,672 $ 1,869,920 General and administrative 1,697,787 1,943,202 Total operating expenses 2,760,459 3,813,122 Loss from operations (2,760,459 ) (3,813,122 ) Other (income) expenses: Interest income (75,522 ) (8,816) Other 32,432 22,646 Total other (income) expenses, net (43,090 ) 13,830 Net loss $ (2,717,369 ) $ (3,826,952 ) Weighted average common shares outstanding, basic and diluted 25,789,739 25,633,217 Net loss per share, basic and diluted $ (0.11 ) $ (0.15 )

AUSTIN, Texas--(BUSINESS WIRE)-- Anebulo Pharmaceuticals, Inc. (Nasdaq: ANEB), a clinical-stage biopharmaceutical company developing novel solutions for people suffering from acute cannabinoid intoxication (ACI) and substance abuse (the “Company” or “Anebulo”), today announced financial results for the three months ended September 30, 2023, and recent updates. First Quarter Fiscal Year 2024 and Subsequent Highlights: Richie Cunningham announced as Chief Executive Officer and Board Member Positive Type B meeting with the United States Food and Drug Administration (FDA), focusing on finalizing our registrational study designs The Company presented at two major scientific meetings: the American College of Emergency Physicians Research Forum and the North American Congress of Clinical Toxicology Secured a credit facility of up to $10 million Bimal Shah announced as Board Member “Anebulo continues to make progress towards becoming the first company to have an approved treatment for ACI. During my brief tenure at Anebulo, I have been profoundly impressed with the team and their expertise in the field of cannabis overdose. I have also had the opportunity to speak with key subject matter experts and key opinion leaders, who have shared their growing enthusiasm for the work we are doing in this area of unmet need,” commented Richie Cunningham, Chief Executive Officer of Anebulo. “The Company is at a critical juncture in its history as we endeavor to pioneer a much-needed solution to this large and growing problem. Data collected has been encouraging both on safety and efficacy, resulting in positive feedback from the FDA following a Type B meeting in July. The FDA indicated that a single, well-controlled study of ANEB-001 in ACI patients presenting to the emergency department (ED), combined with a larger THC challenge study in volunteers, could potentially provide substantial evidence to support a new drug application. Furthermore, recent data presented at the American College of Emergency Physicians Research Forum, included a pharmacokinetic / pharmacodynamic model of data from the THC challenge study of ANEB-001 in healthy volunteers. The model predicted that 10 mg ANEB-001 can rapidly reverse the effects of feeling high on THC doses up to 100 mg, a dose that cannot be directly tested in healthy volunteers, but may be relevant to the ED setting. “The potential of being first to market with an ACI treatment, offers Anebulo shareholders a tremendous opportunity for potential value creation. In preparation for initiation of the two Phase 3 studies, we are focusing on finalizing our registrational study designs, while continuing our dialogue with the FDA. We aim to confirm our belief that ANEB-001 can significantly reduce the treatment time of ACI patients by several hours, while providing superior patient outcomes. “Based on our company sponsored survey of 27 U.S. emergency room physicians, who on average each saw 10.5 patients per month with ACI, indicated there is a real need for a cannabinoid antagonist such as ANEB-001 to treat ACI in the ED setting. In addition to poor patient outcomes, ACI places a substantial burden on the healthcare system, especially for patients who present with concomitant neuropsychiatric symptoms. When you consider the deregulation of cannabis, this growing trend, has the potential to result in more patients, both young and old, showing up in EDs with moderate to severe ACI. “Lastly, the Company has recently strengthened its capital structure by executing a credit facility with certain existing investors, that will allow us access up to $10 million. This facility reflects their on-going confidence and support as we prepare to initiate Phase 3 trials.” Financial Results for the three months ended September 30, 2023 Operating expenses in the first quarter of fiscal 2024 were $2.5 million compared with $2.6 million in the same period in fiscal 2023. Net loss in the first quarter of fiscal 2024 was $2.5 million, or $(0.10) per share, compared with a net loss of $2.6 million, or $(0.11) per share, in the first quarter of fiscal 2023. Cash was $8.5 million as of September 30, 2023. About Anebulo Pharmaceuticals, Inc. Anebulo Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company developing novel solutions for people suffering from acute cannabinoid intoxication and substance abuse disorder. Its lead product candidate, ANEB-001, has completed dosing in a Phase 2 clinical trial ( ) evaluating its utility in blocking and reversing the negative effects of acute cannabinoid intoxication. ANEB-001 is a competitive antagonist at the human cannabinoid receptor type 1 (CB1). For further information about Anebulo, please visit . About ANEB-001 Our lead product candidate is ANEB-001, a potent, small molecule cannabinoid receptor antagonist, under development 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 are targeting initiation of Phase 3 registrational studies of ANEB-001 in the first half of calendar 2024. In addition, an observational study in patients presenting to EDs with ACI is currently ongoing. The study will determine concentrations of cannabinoids and metabolites in plasma and gather information on signs and symptoms, patients’ disposition and selected subjective assessments. 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: the potential for a single well-controlled study of ANEB-001 in ACI patients presenting to the ED combined with a larger THC challenge study in volunteers to provide substantial evidence to support a new drug application; Anebulo’s ability to become the first company to have an approved treatment for ACI; the potential value that ANEB-001 may create for stockholders if approved; intent to commence phase 3 registrational trials in the first half of 2024; the potential for ANEB-001 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; the ability to obtain regulatory approval; the stockholder value anticipated to be created if ANEB-001 is approved may not materialize or be as significant as anticipated; the Type B feedback should not be relied on as an indication that ANEB-001 will ultimately be approved; 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 health crises or geopolitical issues; and Anebulo's need for additional capital. These and other risks are described under the "Risk Factors" heading of Anebulo's Annual Report on form 10-K for the fiscal year ending June 30, 2023, filed with the SEC on September 22, 2023, and Anebulo’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2023, being filed with the SEC later today. All forward-looking statements made in this press release speak only as of the date of this press release and are based on management's assumptions and estimates as of such date. Except as required by law, Anebulo undertakes no obligation to update or revise forward-looking statements to reflect new information, future events, changed conditions or otherwise after the date of this press release. Condensed Balance Sheets September 30, June 30, 2023 2023 Cash $ 8,520,578 $ 11,247,403 Total assets 9,047,884 11,670,151 Total liabilities 716,560 1,068,801 Total stockholders’ equity 8,331,324 10,601,350 Condensed Statements of Operations Three Months Ended September 30, 2023 2022 Research and development $ 1,270,220 $ 1,223,776 General and administrative 1,273,458 1,388,271 Total operating expenses 2,543,678 2,612,047 Loss from operations (2,543,678 ) (2,612,047 ) Other (income) expenses: Interest income (55,198 ) - Other (7,657 ) 212 Total other (income) expenses, net (62,855 ) 212 Net loss $ (2,480,823 ) $ (2,611,835 ) Weighted average common shares outstanding, basic and diluted 25,633,217 23,416,495 Net loss per share, basic and diluted $ (0.10 ) $ (0.11 )

AUSTIN, Texas--(BUSINESS WIRE)-- Anebulo Pharmaceuticals, Inc. (Nasdaq: ANEB), a clinical-stage biopharmaceutical company developing novel solutions for people suffering from acute cannabinoid intoxication (ACI) and substance abuse (the “Company” or “Anebulo”), today announced financial results for the three and twelve months ended June 30, 2023, and recent updates. Fourth Quarter Fiscal Year 2023 and Subsequent Highlights: Positive feedback from the Type B meeting with the FDA supports advancing ANEB-001 to registrational studies. Dosing completed in Part C open-label extension of Phase 2 study evaluating up to a 60 mg challenge of THC with ANEB-001 given simultaneously in healthy volunteers. Data readout anticipated in Q4 2023. Observational PK study in patients reporting to the emergency department with ACI is ongoing. The Company will present at the following scientific conferences: North American Congress on Clinical Toxicology in Montreal, Quebec: Oral Presentation on September 29 from 1 p.m. to 3 p.m. ET. American Congress of Emergency Physicians in Philadelphia, PA: Poster presentation on October 9 at 10:30 a.m. ET and oral presentation on October 10, 2023, at 3:30 p.m. ET. Management Commentary “I am grateful for our team’s hard work and diligence in transitioning Anebulo to a Phase 3-ready company, a very important step in our mission to make ANEB-001 available to individuals who present at emergency departments with cannabinoid intoxication,” commented Simon Allen, Chief Executive Officer of Anebulo. “We believe ANEB-001 can significantly reduce the treatment time of ACI patients by several hours while providing superior patient outcomes. We are targeting to initiate Phase 3 registrational studies in the first half of 2024.” Financial Results for the three months ended June 30, 2023 Operating expenses in the fourth quarter of fiscal 2023 were $2.5 million compared with $2.3 million in the same period in fiscal 2022. Net loss in the fourth quarter of fiscal 2023 was $2.5 million, or $(0.10) per share, compared with a net loss of $2.3 million, or $(0.10) per share, in the fourth quarter of fiscal 2022. Cash was $11.2 million as of June 30, 2023. Financial Results for the twelve months ended June 30, 2023 Operating expenses in fiscal year 2023 were $11.8 million compared with $6.8 million in the same period in fiscal 2022. Research and Development increased approximately $2.6 million over the prior year period, primarily due to increased pre-clinical and clinical studies, and direct third-party costs, in the support of ANEB-001. General and Administrative expenses increased approximately $2.3 million over the prior year period, primarily due to compensation and related benefits, and professional and consultant fees, including legal and accounting fees. Net loss in fiscal year 2023 was $11.7 million, or $(0.47) per share, compared with a net loss of $6.8 million, or $(0.29) per share, in fiscal year 2022. The increase in the net loss was the result of higher operating expenses in fiscal year 2023, as explained above. About Anebulo Pharmaceuticals, Inc. Anebulo Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company developing novel solutions for people suffering from acute cannabinoid intoxication and substance abuse disorder. Its lead product candidate, ANEB-001, has completed dosing in a Phase 2 clinical trial ( ) evaluating its utility in blocking and reversing the negative effects of acute cannabinoid intoxication. ANEB-001 is a competitive antagonist at the human cannabinoid receptor type 1 (CB1). For further information about Anebulo, please visit . About ANEB-001 Our lead product candidate is ANEB-001, a potent, small molecule cannabinoid receptor antagonist, under development 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 are targeting initiation of Phase 3 registrational studies of ANEB-001 in the first half of 2024. In addition, an observational study in patients presenting to Emergency Departments with ACI is currently ongoing. The study will determine concentrations of cannabinoids and metabolites in plasma and gather information on signs and symptoms, patients’ disposition and selected subjective assessments. 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: the potential for a single well-controlled study of ANEB-001 in ACI patients presenting to the emergency department combined with a larger THC challenge study in volunteers to provide substantial evidence to support a new drug application; Anebulo’s intention to applications in the US and foreign jurisdictions to further cover ANEB-001; the expected data read out in Q4 2023 for Anebulo’s open-label Part C extension of its Phase 2 clinical trial; intent to commence phase 3 registrational trials in the first half of 2024; Anebulo’s intention to participate in and present at certain conferences; the potential for ANEB-001 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; the ability to obtain regulatory approval; the Type B feedback should not be relied on as an indication that ANEB-001 will ultimately be approved; 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 health crises 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 March 31, 2023, as filed with the SEC on May 11, 2023. All forward-looking statements made in this press release speak only as of the date of this press release and are based on management's assumptions and estimates as of such date. Except as required by law, Anebulo undertakes no obligation to update or revise forward-looking statements to reflect new information, future events, changed conditions or otherwise after the date of this press release. Condensed Balance Sheets June 30, 2023 2022 Cash $ 11,247,403 $ 14,548,471 Total assets 11,670,151 15,579,431 Total liabilities 1,068,801 512,531 Total stockholders’ equity 10,601,350 15,066,900 Condensed Statements of Operations Three months ended June 30, Year ended June 30, 2023 2022 2023 2022 Research and development $ 1,417,159 $ 1,118,141 $ 5,600,197 $ 2,961,538 General and administrative 1,077,230 1,207,343 6,183,402 3,869,636 Total operating expenses 2,494,389 2,325,484 11,783,599 6,831,174 Loss from operations (2,494,389 ) (2,325,484 ) (11,783,599 ) (6,831,174 ) Other (income) expenses Interest income (6 ) (1,929 ) (92,407 ) (7,332 ) Other 1,197 (813 ) 41,146 1,777 Total other (income) expenses, net 1,191 (2,742 ) (51,261 ) (5,555 ) Net loss $ (2,495,580 ) $ (2,322,742 ) $ (11,732,338 ) $ (6,825,619 )) Weighted average common shares outstanding, basic and diluted 25,633,217 23,344,567 25,074,481 23,344,567 Net loss per share, basic and diluted $ (0.10 ) $ (0.10 ) $ (0.47 ) $ (0.29 )