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Anebulo Pharmaceuticals Reports Fourth Quarter and Fiscal Year 2022 Financial Results and Highlights Recent Business Progress AUSTIN, Texas (

Key Takeaway: Pharmaceuticals Reports Fourth Quarter and Fiscal Year 2022 Results and Highlights Recent Business Progress Texas (September 9, 2022) - Anebulo Pharmaceuticals, Inc. (Nasdaq: ANEB), a clinical-stage biopharmaceutical company developing novel solutions for people suffering from

Full Press Release Details

Pharmaceuticals Reports Fourth Quarter and Fiscal Year 2022
Results and Highlights Recent Business Progress
Texas (September 9, 2022) - Anebulo Pharmaceuticals, Inc. (Nasdaq: ANEB), a clinical-stage biopharmaceutical company developing
novel solutions for people suffering from acute cannabinoid intoxication and substance abuse (the "Company" or "Anebulo"),
today announced financial results for the three months and twelve months ended June 30, 2022 and reported recent business updates.
Quarter Fiscal Year 2022 and Subsequent Highlights:
Anebulo to hold its Inaugural R&D Day in New York City on September 26, 2022
Announced positive topline data from Part A of an ongoing Phase 2 clinical trial evaluating the potential of ANEB-001 to treat acute cannabinoid intoxication (ACI)
Company executives are scheduled to participate in the following investor conferences:
H.C. Wainwright 24 th Annual Global Investment Conference, September 12-14, 2022
Cowen 4 th Annual Cannabis Policy Summit, September 12, 2022
LD Micro Invitational Main Event XV Investor Conference, October 25-27, 2022
Updates and Upcoming Milestones
Company's lead product candidate, ANEB-001, is being developed as a potential treatment to rapidly reverse the negative effects
of ACI. The signs and symptoms of ACI include profound sedation, anxiety, panic, hallucinations, and psychosis. More than
1.7 million emergency department visits in the United States were related to cannabinoid use in 2019, which includes ACI and other
cannabis-related conditions. There are currently no FDA approved drugs to treat ACI.
July 2022, the Company announced positive topline data from Part A of its ongoing Phase 2 clinical trial evaluating the potential of
ANEB-001 to treat ACI. Part A was a 60-subject randomized, double-blind, placebo-controlled trial designed to evaluate the effectiveness
of a single dose of ANEB-001 in treating healthy subjects challenged with delta-9-tetrahydrocannabinol, better known as THC, the primary
psychoactive constituent of cannabis. Healthy subjects received a single dose of oral THC (10.5 mg) with a single oral dose of ANEB-001
(50 mg or 100 mg) or placebo.
topline data demonstrated a significant, robust, and sustained reduction in key symptoms of ACI, including reduction of the VAS feeling
high score (p < 0.0001) and improvement in the VAS alertness scale (p < 0.01). In addition, the proportion of subjects reporting
feeling high on the VAS was significantly reduced by ANEB-001 (p < 0.001). The effects of a 50 mg ANEB-001 were similar to those of
a 100 mg dose, indicating lower doses should be evaluated. ANEB-001 was well tolerated in these healthy volunteers. Preliminary safety
information showed all adverse events were mild and transient, except in the case of one subject in the 50 mg ANEB-001 group who experienced
transient moderate nausea and vomiting.
on the encouraging data from Part A, the Company plans to initiate Part B of the study at CHDR by the end of third quarter 2022 to evaluate
lower doses of ANEB-001. Anebulo is currently collaborating with the Model-Informed Drug Development (MIDD) group at FDA to develop a
PK/PD model that will potentially allow prediction of optimal doses for treatment of ACI subjects. Preparations are ongoing for an observational
study in ACI subjects in the emergency department setting to further support the PK/PD model and ANEB-001 development. Submission of
an Investigational New Drug application (IND) for ANEB-001 to initiate U.S. trials is anticipated by the end of 2022.
"2022 has been a time of diligent execution
as we continue our efforts to develop the first FDA approved therapy for ACI," stated Simon Allen, Chief Executive
Officer of Anebulo. "The positive topline data from Part A of our ongoing Phase 2 trial provided a solid foundation
for the continued development of ANEB-001. As such, we look forward to presenting our strategy and vision for this program
in greater detail, including new Part B data, during our R&D Day on September 26. Operations and expenditures for this most
recent quarter keep us on budget and on target to progress ANEB-001 deeper into the clinic."
Results for the three months ended June 30, 2022
Operating expenses in the fourth quarter of fiscal 2022 were $2.3 million compared with $2.5 million in the same period in fiscal 2021.
Net loss in the fourth quarter of fiscal 2022 was $2.3 million, or $(0.10) per share, compared with a net loss of $29.1 million, or $(1.59) per share, in the fourth quarter of fiscal 2021.
Cash burn in the fourth quarter of fiscal 2022 was $2.0 million.
Cash was $14.5 million as of June 30, 2022.
Results for the twelve months ended June 30, 2022
Operating expenses in fiscal year 2022 were $6.8 million compared with $3.6 million in fiscal year 2021.
Net loss in fiscal year 2022 was $6.8 million, or $(0.29) per share, compared with a net loss of $30.3 million, or $(2.83) per share, in fiscal year 2021.
Cash burn in fiscal year 2022 was $5.4 million.
to Host Inaugural R&D Day in New York City on Monday, September 26
Company will host its inaugural R&D Day on Monday, September 26, 2022, from 10:00 a.m. to 12:30 p.m. (ET) in Midtown, New York City.
Anebulo's CEO, Simon Allen will be joined Dr. Joseph Lawler (Founder and Chairman), Dr. Ken Cundy (CSO) and other
senior executives to discuss the Company's vision and strategy for ANEB-001, including new data from Part B of our ongoing
Investors and financial analysts are invited
to attend and can register via email at AnebuloIR@mww.com.
Anebulo Pharmaceuticals, Inc.
Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company developing novel solutions for people suffering from acute cannabinoid
intoxication and substance abuse. Its lead product candidate, ANEB-001, is intended to reverse the negative effects of acute cannabinoid
intoxication within one hour of administration. ANEB-001 is a competitive antagonist at the human cannabinoid receptor type 1 (CB1).
For further information about Anebulo, please visit www.anebulo.com.
press release contains 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. These forward-looking statements, along with terms such as "anticipate,"
"expect," "intend," "may," "will," "should" and other comparable terms, involve
risks and uncertainties because they relate to events and depend on circumstances that will occur in the future. Those statements include
statements regarding the intent, belief or current expectations of Anebulo Pharmaceuticals and members of its management, as well as
the assumptions on which such statements are based. Prospective investors are cautioned that any such forward-looking statements are
not guarantees of future performance and involve risks and uncertainties, including risks attendant to developing, testing and commercializing
the company's product candidates, and those described in Anebulo Pharmaceutical's most recent annual report on Form 10-K
and in other periodic reports filed with the SEC, and that actual results may differ materially from those contemplated by such forward-looking
statements. Except as required by federal securities law, Anebulo Pharmaceuticals undertakes no obligation to update or revise forward-looking
statements to reflect changed conditions.
Pharmaceuticals, Inc.
of Investor Relations and Public Relations
June 30,
2022 2021
Cash $ 14,548,471 $ 19,985,645
Total assets 15,579,431 21,653,491
Total liabilities 512,531 241,633
Total stockholders' equity 15,066,900 21,411,858
Statements of Operations
Three months ended June 30, Year ended June 30,
2022 2021 2022 2021
Research and development $ 1,118,141 $ 1,806,692 $ 2,961,538 $ 2,269,998
General and administrative 1,207,343 678,013 3,869,636 1,343,755
Total operating expenses 2,325,484 2,484,705 6,831,174 3,613,753
Loss from operations (2,325,484 ) (2,484,705 ) (6,831,174 ) (3,613,753 )
Other (income) expenses
Interest income (1,929 ) (1,020 ) (7,332 ) (1,020 )
Interest expense - - - 11,767
Fair value adjustments for milestone warrants - 26,626,710 - 26,626,710
Other (813 ) 1,344 1,777 1,344
Total other expenses, net (2,742 ) 26,627,034 (5,555 ) 26,638,801
Net loss $ (2,322,742 ) $ (29,111,739 ) $ (6,825,619 ) $ (30,252,554 )
Deemed dividends - - - (8,208,393
Net loss attributable to common stockholders $ (2,322,742 ) $ (29,111,739 ) $ (6,825,619 ) $ (38,460,947 )
Weighted average common share outstanding, basic and diluted 23,344,567 18,293,103 23,344,567 13,612,701
Net loss per share, basic and diluted $ (0.10 ) $ (1.59 ) $ (0.29 ) $ (2.83 )
Last updated: Sep 9, 2022