Anebulo Pharmaceuticals Reports First Quarter Fiscal Year 2025 Financial Results and Recent Updates
Anebulo Pharmaceuticals (ANEB) has reported its Q1 FY2025 financial results and updates. The company received the first tranche of a $1.9 million NIDA grant to advance its intravenous selonabant formulation for treating acute cannabis-induced toxicities. The company plans to complete IND-enabling activities by end of 2024 and enroll first volunteers in H1 2025. Financial results show operating expenses of $2.4 million, with a net loss of $2.2 million ($0.08 per share). Cash position stands at $1.4 million, with access to an additional $10 million through a recent Loan Agreement.
Anebulo Pharmaceuticals (ANEB) ha reso noti i risultati finanziari del Q1 FY2025 e gli aggiornamenti. L'azienda ha ricevuto la prima tranche di un finanziamento NIDA di 1,9 milioni di dollari per sviluppare la sua formulazione di selonabant per via intramuscolare per il trattamento delle tossicità acute indotte da cannabis. L'azienda prevede di completare le attività per l'ottenimento dell'IND entro la fine del 2024 e di arruolare i primi volontari nel primo semestre del 2025. I risultati finanziari mostrano spese operative di 2,4 milioni di dollari, con una perdita netta di 2,2 milioni di dollari ($0,08 per azione). La posizione di cassa si attesta a 1,4 milioni di dollari, con accesso a ulteriori 10 milioni di dollari tramite un recente contratto di prestito.
Anebulo Pharmaceuticals (ANEB) ha informado sus resultados financieros del Q1 FY2025 y actualizaciones. La compañía recibió el primer tramo de una subvención NIDA de 1.9 millones de dólares para avanzar en su formulación de selonabant intravenosa para tratar toxicidades agudas inducidas por cannabis. La empresa planea completar las actividades habilitantes del IND para finales de 2024 y reclutar a los primeros voluntarios en el primer semestre de 2025. Los resultados financieros muestran gastos operativos de 2.4 millones de dólares, con una pérdida neta de 2.2 millones de dólares ($0.08 por acción). La posición de efectivo se sitúa en 1.4 millones de dólares, con acceso a un adicional de 10 millones de dólares a través de un reciente Acuerdo de Préstamo.
Anebulo Pharmaceuticals (ANEB)는 FY2025 1분기 재무 결과 및 업데이트를 발표했습니다. 이 회사는 급성 대마초 유도 독성 치료를 위한 정맥 주사용 selonabant 제형을 개발하기 위해 190만 달러 NIDA 보조금의 첫 번째 분할금을 받았습니다. 회사는 2024년 말까지 IND 승인 가능 활동을 완료하고 2025년 상반기에 첫 자원봉사자를 모집할 계획입니다. 재무 결과는 240만 달러의 운영 비용과 220만 달러 ($0.08 per 주식)의 순손실을 보여줍니다. 현금 보유액은 140만 달러이며, 최근 대출 계약을 통해 추가 1000만 달러에 접근할 수 있습니다.
Anebulo Pharmaceuticals (ANEB) a annoncé ses résultats financiers pour le premier trimestre de l'exercice 2025 et des mises à jour. L'entreprise a reçu la première tranche d'une subvention NIDA de 1,9 million de dollars pour faire progresser sa formulation de selonabant intraveineuse pour traiter les toxicités aiguës induites par le cannabis. L'entreprise prévoit de terminer les activités permettant d'obtenir l'IND d'ici la fin de 2024 et de recruter les premiers bénévoles au premier semestre 2025. Les résultats financiers montrent des dépenses opérationnelles de 2,4 millions de dollars, avec une perte nette de 2,2 millions de dollars (0,08 $ par action). La position de trésorerie s'élève à 1,4 million de dollars, avec un accès à un supplément de 10 millions de dollars grâce à un récent contrat de prêt.
Anebulo Pharmaceuticals (ANEB) hat seine finanziellen Ergebnisse für das Q1 des Geschäftsjahres 2025 und aktuelle Informationen veröffentlicht. Das Unternehmen erhielt die erste Tranche eines 1,9 Millionen Dollar NIDA-Stipendiums, um seine intravenöse Selonabant-Formulierung zur Behandlung akuter durch Cannabis verursachter Toxizitäten voranzutreiben. Das Unternehmen plant, die IND-ermöglichenden Aktivitäten bis Ende 2024 abzuschließen und im ersten Halbjahr 2025 die ersten Freiwilligen zu rekrutieren. Die finanziellen Ergebnisse zeigen Betriebsausgaben von 2,4 Millionen Dollar, mit einem Nettoverlust von 2,2 Millionen Dollar (0,08 Dollar pro Aktie). Die Liquiditätsposition liegt bei 1,4 Millionen Dollar, mit Zugang zu weiteren 10 Millionen Dollar durch einen kürzlichen Darlehensvertrag.
- Secured NIDA grant worth $1.9 million for development of IV selonabant
- Access to additional $10 million through Loan and Security Agreement
- Reduced net loss to $2.2 million from $2.5 million year-over-year
- Operating expenses decreased to $2.4 million from $2.5 million year-over-year
- Low cash position of $1.4 million as of September 30, 2024
- Continued quarterly net losses ($2.2 million)
Insights
The quarterly results and funding updates present a mixed financial picture. The
The NIDA grant validates the company's development direction and provides non-dilutive funding. However, with a quarterly cash burn rate of approximately
The development of an IV formulation of selonabant for acute cannabis toxicity represents a significant market opportunity, particularly in pediatric emergency care. The successful Phase 2 proof of concept for oral selonabant and NIDA's support indicate promising clinical potential. The focus on pediatric cannabis toxicity addresses a critical unmet need, as children are particularly vulnerable to severe CNS depression and respiratory complications from cannabis exposure.
The planned progression to clinical studies with the IV formulation by early 2025 could accelerate the path to market for emergency applications. The emphasis on rapid intervention capability through IV administration could provide a important advantage over existing treatment options.
First Quarter Fiscal Year 2025 and Subsequent Highlights:
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Anebulo announced it has been awarded the first tranche of a two-year cooperative grant of up to approximately
$1.9 million - With the support of NIDA, Anebulo aims to complete IND-enabling activities and the scale up of its intravenous (IV) formulation of selonabant around calendar year end 2024 as it prepares for clinical studies and the Company expects to enroll the first healthy adult volunteer in the first half of calendar 2025.
“We are excited to have the support of NIDA to advance our development of a rapid and clinically impactful emergency treatment for acute cannabis-induced toxicities, including cannabis-induced Central Nervous System (CNS) depression in children,” commented Richie Cunningham, Chief Executive Officer of Anebulo.
“We believe this important grant from NIDA recognizes the significant progress we have already made with the successful Phase 2 proof of concept study of oral selonabant. This grant, along with our access to an additional
Financial Results for the three months ended September 30, 2024
-
Operating expenses in the first quarter of fiscal 2025 were
$2.4 million $2.5 million -
Net loss in the first quarter of fiscal 2025 was
$2.2 million $(0.08) $2.5 million $(0.10) -
Cash and cash equivalents were
$1.4 million $10 million
About Selonabant (ANEB-001)
The Company’s lead product candidate is selonabant (ANEB-001), a potent, small molecule antagonist of the cannabinoid receptor type-1 (“CB1”), under development to address the unmet medical need for a specific antidote for acute cannabis-induced toxicity, including acute cannabinoid intoxication (“ACI”) in adults and unintentional cannabis poisoning in pediatric subjects. The Company anticipates that selonabant will rapidly reverse key symptoms of cannabis toxicity. Selonabant has been successfully formulated for oral administration in clinical studies and t as a potential IV treatment. In a Phase 2 proof-of-concept study in adult subjects challenged with oral delta-9-tetrahydrocannabinol (“THC”) (www.clinicaltrials.gov/ct2/show/NCT05282797), oral selonabant blocked or reversed key CNS effects of THC. Selonabant was well tolerated in this study and there were no serious adverse events. In the open-label extension of the study, THC challenge doses of 40 mg and 60 mg were well-tolerated when dosed in combination with oral selonabant, and all treatment-related adverse events were mild and transient. The prior Phase 1 and Phase 2 studies of oral selonabant have together enrolled a total of 250 subjects, of which 189 received selonabant. Selonabant is protected by two issued patents covering various methods of use of the compound and composition of matter of the crystalline form of selonabant. Anebulo also has multiple pending applications covering various methods of use of the compound and delivery systems. An observational study in patients presenting to Emergency Departments with cannabis toxicity is currently ongoing. The study is intended to 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 pharmaceutical company developing novel solutions for people suffering from acute cannabinoid intoxication and unintentional cannabis intoxication. Its lead product candidate, selonabant, has completed a Phase 2 clinical trial evaluating its utility in blocking and reversing the negative effects of acute cannabinoid intoxication in healthy adults challenged with oral THC. Rather than proceeding directly with Phase 3 studies of oral selonabant in adults with ACI, the Company is prioritizing the advancement of a selonabant IV formulation as a potential treatment for pediatric patients with acute cannabis-induced toxicity, which it believes offers the potential for a faster timeline to approval relative to the adult oral product. Anebulo is currently scaling up the intravenous formulation for initial clinical safety studies. Selonabant is a competitive antagonist at the human CB1 receptor. For further information about Anebulo, please visit www.anebulo.com.
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 healthy adult volunteer in the first half of 2025; the grant from NIDA recognizing the significant progress the Company has already made with the successful Phase 2 proof of concept study of oral selonabant; the grant further validating the significant and growing unmet medical need for an emergency antidote to acute cannabis-induced toxicity; the potential of selonabant to offer a much-needed targeted therapy for rapidly reversing the serious and life-threatening consequences of accidental cannabis ingestion in children; the observational study determining concentrations of cannabinoids and metabolites in plasma and gathering information on signs and symptoms, patients’ disposition and selected subjective assessments; and advancement of a selonabant IV formulation as a potential treatment for pediatric patients with acute cannabis-induced toxicity, offering the potential for a faster timeline to approval relative to the adult oral product. 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: the Company’s ability to pursue its regulatory strategy including completion of IND enabling activities and scale up of the intravenous formulation of selonabant around year end 2024 and enrolling the first healthy adult volunteer in the first half of 2025, its ability to obtain regulatory approvals for commercialization of product candidates or to comply with ongoing regulatory requirements, the Company’s ability to obtain or maintain the capital or grants necessary to fund its research and development activities, its ability to complete clinical trials on time and achieve desired results and benefits as expected, regulatory limitations relating to the ability to promote or commercialize product candidates for specific indications, acceptance of product candidates in the marketplace and the successful development, marketing or sale of Anebulo’s products, the Company’s ability to maintain its license agreements, the continued maintenance and growth of its patent estate and the Company’s ability to retain its key employees or maintain its Nasdaq listing. These risks should not be construed as exhaustive and should be read together with the other cautionary statements included in the Company’s Annual Report on Form 10-K for the year ended June 30, 2024, and its subsequent filings with the Securities and Exchange Commission, including subsequent periodic reports on Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. 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 |
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|
|
||||||
|
|
September 30, 2024 |
|
|
June 30, 2024 |
|
||
Cash and cash equivalents |
|
$ |
1,404,211 |
|
|
$ |
3,094,200 |
|
Total assets |
|
|
2,467,940 |
|
|
|
4,073,114 |
|
Total liabilities |
|
|
569,225 |
|
|
|
260,583 |
|
Total stockholders’ equity |
|
|
1,898,715 |
|
|
|
3,812,531 |
|
Condensed Statements of Operations |
||||||||
|
|
Three months ended September 30, |
|
|||||
|
|
2024 |
|
|
2023 |
|
||
Research and development |
|
$ |
1,314,859 |
|
|
$ |
1,270,220 |
|
General and administrative |
|
|
1,097,265 |
|
|
|
1,273,458 |
|
Total operating expenses |
|
|
2,412,124 |
|
|
|
2,543,678 |
|
Loss from operations |
|
|
(2,412,124 |
) |
|
|
(2,543,678 |
) |
Other (income) expenses: |
|
|
|
|
|
|
|
|
Interest expense |
|
|
59,697 |
|
|
|
- |
|
Interest income |
|
|
(26,006 |
) |
|
|
(55,198 |
) |
Grant income |
|
|
(245,362 |
) |
|
|
- |
|
Other |
|
|
283 |
|
|
|
(7,657 |
) |
Total other income, net |
|
|
(211,388 |
) |
|
|
(62,855 |
) |
Net loss |
|
$ |
(2,200,736 |
) |
|
$ |
(2,480,823 |
) |
Weighted average common shares outstanding, basic and diluted |
|
|
25,933,217 |
|
|
|
25,633,217 |
|
Net loss per share, basic and diluted |
|
$ |
(0.08 |
) |
|
$ |
(0.10 |
) |
View source version on businesswire.com: https://www.businesswire.com/news/home/20241113619603/en/
Anebulo Pharmaceuticals, Inc.
Daniel George
Part time Chief Financial Officer
(512) 598-0931
Dan@anebulo.com
Source: Anebulo Pharmaceuticals, Inc.
FAQ
What was Anebulo Pharmaceuticals (ANEB) Q1 FY2025 net loss?
How much grant funding did ANEB receive from NIDA in 2024?
What is ANEB's cash position as of September 30, 2024?
When does ANEB expect to enroll first volunteers for IV selonabant clinical studies?
