Anebulo Pharmaceuticals Reports Fourth Quarter and Fiscal 2021 Financial Results and Business Update

AUSTIN, Texas – (COMMERCIAL THREAD) – Anebulo Pharmaceuticals, Inc. (Nasdaq: ANEB), a clinical-stage biopharmaceutical company developing new solutions for people with acute cannabinoid poisoning and drug addiction, today announced its financial results for the three and 12 months ended June 30, 2021 and reported recent company highlights.

Highlights of activities for the fourth quarter of fiscal 2021 and recent weeks are as follows:

• Manufacturing of ANEB-001 capsules completed for the next phase 2 clinical trial. In accordance with current good manufacturing practice requirements, the Company delivered the active pharmaceutical ingredient of ANEB-001 to its subcontractor for filling with 10 mg and 50 mg capsules for the finished product.

• Formation of the Scientific Advisory Board (SAB) with two founding co-chairs. In August 2021, the Company formed the SAB to advise the Company on its clinical development programs and product portfolio. The founding co-chairs are Andrew Monte, MD, Ph.D. and Arjun Chanmugam, MD, both recognized leaders in emergency medicine.

• Initial closed public offering (IPO) of ordinary shares. The Company completed its IPO of 3,078,224 common shares at $ 7.00 per share for gross proceeds of $ 21.5 million to Anebulo. On May 7, 2021, the Company’s common shares began trading on the Nasdaq Capital Market under the symbol ANEB.

• Raised sufficient capital to fund operations through calendar year 2022. Management estimates that the net IPO proceeds of $ 19.8 million provide adequate funding for the Company’s planned business activities and clinical studies through the end of calendar year 2022.

• On track to begin Phase 2 proof-of-concept clinical trial with ANEB-001 for the treatment of acute cannabinoid poisoning in Q4 2021. The planned phase 2 study will take place at a single site in the Netherlands and has been approved by the institution’s regulatory and ethics committee. The study is expected to recruit 100 healthy volunteers, each receiving 10 mg of THC orally, and then randomized to receive one of three doses of ANEB-001 or a placebo. The Company expects the first results to be available in the first half of 2022.

Management commentary

“We are delighted with our progress towards the launch of the Phase 2 clinical study of ANEB-001 for the treatment of patients with acute cannabinoid poisoning later this year. As the number of emergency room visits related to cannabis poisoning continues to increase by approximately 15% per year, we believe there is a significant unmet medical need for our drug candidate, ”said Daniel Schneeberger, MD , CEO of Anebulo. “Manufacturing the finished product for ANEB-001 was a critical step in preparing for our proof of concept study in the Netherlands. In addition, we were delighted to announce the formation of our SAB with founding members who bring significant expertise in emergency medicine and medical toxicology. We intend to expand the SAB over time and look forward to their valuable contributions in our initial indication, as well as in exploring other potential indications to expand our addressable market. ”

Financial results

Anebulo Pharmaceuticals started operations in May 2020. So all comparisons from the previous year reflect approximately one month of operation.

• Operating expenses for the fourth quarter of fiscal 2021 were $ 2,484,705, compared to $ 173,351 for the same period of fiscal 2020. Operating expenses for fiscal 2021 were high. at $ 3,613,753 compared to $ 173,351 in fiscal 2020.

• The net loss in the fourth quarter of fiscal 2021 was $ 29,111,739, or ($ 1.59) per share, compared to a net loss of $ 174,637, or ($ 0.01) per share, in the fourth quarter of fiscal 2020. The net loss for fiscal 2021 was $ 30,252,554, or ($ 2.83) per share, compared to a net loss of $ 174,637, or ($ 0.01) per share. share, during fiscal year 2020. The number of shares outstanding has been adjusted to reflect the 6: 1 stock split performed prior to the Company’s IPO on May 6, 2021.

• Cash was approximately $ 20 million as of June 30, 2021.

About ANEB-001

Anebulo believes that ANEB-001 is an asset with a well understood mechanism of action. ANEB-001 is a competitive antagonist of the human CB1 receptor with an affinity of 0.6 nM with good oral bioavailability and good brain penetration (brain: plasma ratio = 1.5). ANEB-001 has been shown to antagonize THC-induced hypolocomotion in mice, a response mediated by CB1 receptors.

ANEB-001 is in development for oral administration, reaches potentially therapeutic blood levels within 30 minutes, and is believed to rapidly reverse signs and symptoms of cannabinoid overdose in less than an hour. Anebulo believes that there is a low likelihood of drug interactions, as preclinical testing has shown that ANEB-001 does not inhibit metabolic cytochromes 1A2, 2C9, 2C19, 2D6 and 3A4 at pharmacologically relevant concentrations. No product is approved for acute cannabinoid poisoning, and Anebulo is not aware of any competitor products for reversing symptoms of cannabinoid poisoning that are more advanced in the developmental process than ANEB-001.

About Anebulo Pharmaceuticals, Inc.

Anebulo Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company developing new solutions for people with acute cannabinoid poisoning and addiction. Its lead product candidate, ANEB-001, is intended to reverse the negative effects of acute cannabinoid poisoning within one hour of administration. Clinical trials completed to date have shown that ANEB-001 is rapidly absorbed, well tolerated and causes weight loss, an effect consistent with type 1 central cannabinoid receptor antagonism. For more information on Anebulo, please visit www.anebulo.com.

Forward-looking statements

This 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, as well as 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. These statements include statements regarding the current intention, belief or expectations of Anebulo Pharmaceuticals and members of its management, as well as the assumptions on which these statements are based. Potential investors are cautioned that these forward-looking statements are not guarantees of future performance and involve risks and uncertainties, including risks relating to the development, testing and commercialization of the Company’s product candidates, including financing. clinical trials, and those described in Anebulo Pharmaceutical 2021. Annual Report on Form 10-K filed with the SEC, and that actual results may differ materially from those contemplated in these forward-looking statements. Except as required by Federal Securities Law, Anebulo Pharmaceuticals assumes no obligation to update or revise any forward-looking statements to reflect the amended terms.

Anebulo Pharmaceuticals, Inc.

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