BORDEAUX, France–(BUSINESS WIRE)–Regulatory News:

Aelis Farma (ISIN: FR0014007ZB4 – ticker: AELIS, PEA-PME eligible), a clinical-stage biopharmaceutical company specialized in the development of treatments for brain diseases, today announces that its half-year financial report has been made available to the public and filled with the French Financial Markets Authority (Autorité des marchés financiers).

It can be consulted on the Company’s website, www.aelisfarma.com, in the section Investors/Documentation/Reports.

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About AELIS FARMA

Founded in 2013, Aelis Farma is a biopharmaceutical company that is developing a new class of drugs, the Signaling Specific inhibitors of the CB1 receptor of the endocannabinoid system (CB1-SSi). These new molecular entities hold great potential in the treatment of many brain diseases. CB1-SSi were developed by Aelis Farma on the basis of the discovery of a new natural defense mechanism of the brain made by the team of Dr. Pier Vincenzo Piazza, CEO of the Company, when he was Director of the Inserm Magendie Neurocenter in Bordeaux. For these discoveries, Dr. Piazza was awarded the Inserm Grand Prix and the Grand Prix of Neurology of the French Academy of Sciences, which are among the most prestigious French prizes in medicine and neurology.

Aelis Farma is developing two first-in-class drug candidates that are at the clinical stage, AEF0117 and AEF0217, and has a portfolio

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 addiction (the “Company” or “Anebulo”), today announced positive interim data from the first two cohorts of Part B of its ongoing Phase 2 clinical trial evaluating ANEB-001 as a treatment for ACI.

The first two cohorts were challenged with 21 mg of THC, dosed orally (twice the THC dose used in Part A). Subjects then received 30mg (cohort 1) or 10mg (cohort 2) oral doses of ANEB-001, or matching placebo. The interim data available from Part B include pharmacokinetics, key pharmacodynamic outcomes, and blinded safety data. Based on these data, subjects challenged with a higher 21 mg oral THC dose and treated with placebo showed greater central nervous system (CNS) effects than observed in Part A with 10.5 mg THC. The effects included a substantial increase in feeling high and body sway, decreased alertness, and slightly increased heart rate compared to baseline. In contrast, treatment of subjects with 10 mg or 30 mg ANEB-001 led to significant and sustained reductions in the visual analog scale (VAS) feeling high score (p < 0.001), improvement in the VAS alertness scale (p < 0.01), and a reduction in THC-induced body sway (p < 0.01), compared to placebo.

In addition, 100% of subjects given 21 mg THC with placebo in Cohorts 1 and 2 met the VAS threshold for feeling high (>20 mm on the 100 mm VAS scale) compared to only 1 subject per group treated with ANEB-001 at 10 mg or 30 mg doses. Although the THC-induced increase in heart rate in this study was small, there was a trend towards improvement with ANEB-001 compared to placebo. The 10 mg and 30 mg ANEB-001 doses had similar effects to previous higher doses used in Part A, despite doubling the THC dose. Pharmacokinetic data from Part A and the first two cohorts of Part B confirmed rapid absorption and dose-related plasma exposure for oral ANEB-001.

“These new Part B data showed that 10mg of ANEB-001 reversed key symptoms of ACI, comparing favorably to our Part A data showing similar effects with 50mg and 100mg. The 10mg data is even more impressive considering we doubled the THC challenge to 21mg in that cohort,” said Simon Allen, Chief Executive Officer of Anebulo. “Using lower doses of ANEB-001 to reduce ACI symptoms should allow us to optimize tolerability, while providing an even more favorable cost of goods if ANEB-001 is approved. We are currently exploring the effects of delayed dosing to better understand real-world conditions. In this circumstance, we challenge subjects with THC one hour before administering ANEB-001. With no FDA approved therapeutic, ACI often requires lengthy emergency department stays with expensive follow-on interventions for neuropsychiatric complications such as anxiety and acute psychosis. We believe ANEB-001 will play a critical role in reducing the burden of ACI for the patient and the healthcare system.”

The Phase 2 study is being conducted in healthy adult occasional cannabis users at the Centre for Human Drug Research (CHDR) in the Netherlands. Results of Part A of the study, announced in July 2022, showed positive effects of 50 mg or 100 mg of ANEB-001 in reducing the effects of a 10.5 mg oral THC dose. Part B of the study is an adaptive study design intended to evaluate lower doses of ANEB-001 at higher levels of THC. We intend to enroll a total of at least 6 cohorts in Part B, with up to 15 subjects per cohort, randomized 2:1 to active versus placebo.

Based on Part A and interim Part B results, the Company is continuing Part B of the study at CHDR to further evaluate the dose response and the effects of separating the doses of THC and ANEB-001. Enrollment of the third cohort of Part B is ongoing. Anebulo is currently collaborating with the Model-Informed Drug Development (MIDD) group at FDA to develop a PK/PD model that will be designed to predict 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. Based on blinded safety data, adverse events in Cohorts 1 and 2 were mild and transient, except for two cases of moderate dizziness in Cohort 1 likely attributable to THC.

About ANEB-001

Our lead product candidate is ANEB-001, a potent, small molecule cannabinoid receptor antagonist, to address the unmet medical need for a specific antidote for ACI. ANEB-001 is an orally bioavailable, rapidly absorbed treatment candidate that we anticipate will reverse the symptoms of ACI, in most cases within 1 hour of administration. 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 began a Phase 2 proof-of-concept trial for ANEB-001 in December 2021 in the Netherlands and announced positive Phase 2 Part A proof-of-concept topline data on July 5, 2022 and positive Part B data on September 26, 2022.

About Acute Cannabinoid Intoxication (ACI)

Symptoms of ACI can include increased somnolence, impaired cognition and perception, disorientation, anxiety, and acute psychosis. According to DSM-5, a diagnosis of cannabinoid intoxication should include recent history of cannabinoid use, clinically considerable behavioral or psychological changes, such as euphoria, impaired judgment and motor skills, which have taken place since cannabinoid exposure.

About Visual Analogue Scale (VAS)

VAS is a validated tool commonly used to help rate the intensity of certain subjective sensations and feelings, such as feeling high. For example, for rating feeling high, the visual analog scale is typically a straight line with one end meaning not high and the other end meaning extremely high. A subject marks a point on the line that matches how high they feel.

About CHDR

The Centre for Human Drug Research (CHDR) is an independent institute that specializes in cutting-edge early-stage clinical drug research. Combining innovative methods and technologies, state-of-the-art facilities, and talented, motivated researchers helps CHDR maximize their clients’ success. In addition, CHDR places the highest priority on their subjects’ comfort and safety, and they play an active role in helping educate the medical and clinical research communities.

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, is currently in a Phase 2 clinical trial (www.clinicaltrials.gov/ct2/show/NCT05282797) to evaluate its utility in reversing 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.

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,” “believe,” “designed,” “expect,” “intend,” “may,” “will,” “should” and other comparable terms. Forward-looking statements include statements regarding Anebulo’s intentions, beliefs, projections, outlook, analyses or current expectations regarding: our belief that using lower doses of ANEB-001 to reduce ACI symptoms should allow us to optimize safety and tolerability, while providing an even more favorable cost of goods if ANEB-001 is approved; our belief that ANEB-001 will play a critical role in reducing the burden of ACI for the patient and the healthcare system; the PK/PD model we are developing in collaboration with MIDD and its expected design and capabilities; are planned observational study in ACI subjects in the emergency department setting and its expected benefits; statements related to the remainder of Part B of the Phase 2 study; 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; clinical trial site challenges that may impact the expected timing of the Company’s ongoing clinical trials, including challenges related to the ongoing COVID-19 pandemic; the timing and success of clinical trials and potential safety and other complications thereof; future supply or manufacturing issues; our ability to successfully commercialize and distribute ANEB-001, if approved; any negative effects on the Company’s business and product development plans caused by or associated with COVID-19 or geopolitical issues; and our need for additional capital. These and other risks are described in under the “Risk Factors” heading of Anebulo’s most recent annual report on Form 10-K filed with the Securities and Exchange Commission (SEC) on September 9, 2022. 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.

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 addiction (the “Company” or “Anebulo”), today announced that it has agreed to sell an aggregate of 2,264,650 common shares and accompanying warrants to purchase up to 2,264,650 shares of common stock to certain institutional accredited investors through a private investment in public equity (“PIPE”) financing at a price of $2.935 per share and accompanying warrant. The warrants have an exercise price of $4.215 per share, are exercisable immediately, and will expire five years following the date of issuance. The closing of the PIPE is expected to occur on or about September 29, 2022, subject to customary closing conditions.

The PIPE financing included participation from new and existing investors, including 22NW, L.P. and its affiliates.

The Company anticipates using the net proceeds from the private placement to advance the development of ANEB-001 and for other general corporate purposes.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

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 addiction. Its lead product candidate, ANEB-001, is currently in a Phase 2 clinical trial (www.clinicaltrials.gov/ct2/show/NCT05282797) to evaluate its utility in reversing the negative effects of acute cannabinoid intoxication within one hour of administration. This trial is being run in the Netherlands by the Centre for Human Drug Research (CHDR). ANEB-001 is a competitive antagonist at the human cannabinoid receptor type 1 (CB1). 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,” “expect” and other comparable terms. Forward-looking statements include statements regarding the timing, size and completion of the private placement as well as the anticipated use of the net proceeds therefrom. 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, risks associated with market conditions and the Company’s business. These and other risks are described in under the “Risk Factors” heading of Anebulo’s most recent annual report on Form 10-K filed with the Securities and Exchange Commission (SEC) on September 9, 2022. 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.

BORDEAUX, France–(BUSINESS WIRE)–Regulatory News:

Aelis Farma (Paris: AELIS)(ISIN: FR0014007ZB4 – ticker: AELIS, PEA-PME eligible), a clinical-stage biopharmaceutical company specialized in the development of treatments for brain diseases, today announces its half-year results for the period ended June 30, 2022 and takes stock of its development.

Pier Vincenzo Piazza, CEO of Aelis Farma, said: “We are very happy with the progress made during the first months of our listing on Euronext. Raising €25.3 million during our IPO in February allowed us to considerably strengthen our financial structure and be able to deploy our strategy with a high visibility. In accordance with the roadmap presented to the financial community, we have reached an important milestone with the recruitment of the first patient in the phase 2b study with Aelis Farma most advanced compound: AEF0117 for the treatment of cannabis addiction. The second part of the year promises to be just as dynamic, in particular with the expected passage of our second drug candidate, AEF0217, into phase 1/2 in individuals with Down Syndrome (Trisomy 21). Built around the discovery of a new class of drugs, the CB₁-SSi, we believe Aelis Farma to be one of the most innovative companies in the field of brain diseases. Thanks to the progress of our various clinical programs, we are convinced that we can become one of the leading players in this space that has significant unmet medical needs.”

Half-year results 2022 (IFRS)

In the first half of 2022, Aelis Farma recorded income from ordinary activities of €4.3 million, of which:

• €2 million corresponding to the recognition, according to IFRS 15, of the share of revenue related to the sub-license option contract with Indivior PLC, a leading group in the treatment of addictions, for AEF0117 in cannabis use disorders. The balance of the lump sum payment received and remaining to be recognized over the residual term of the option is €13.6 million.
• €2.3 million of other income from ordinary activities consisting of the Research Tax Credit (€837 thousand) and operating subsidies (€1.424 million) relating to the research programs carried out by Aelis Farma. Their increase compared to the previous year is correlated to the increase in research and development expenses incurred over the half-year.

Research and development costs

The change in research and development costs (+124.7%) reflects the ramp-up of the development program for drug candidates AEF0117 and AEF0217, and the strengthening of research team. The decrease in intellectual property costs is explained by the payment, in 2021, of royalties (€1.2 million) to patent owners following the signing of the sublicense option agreement with Indivior PLC.

As of June 30, 2022 the operating result shows a loss of € (4.642) million against a profit of €4.647 million at June 30, 2021. This change is mainly due to:

• the start of the phase 2b study of AEF0117 and the pharmaceutical production activities (CMC) for both AEF0117 and AEF0217; and
• by the schedule of revenue recognition of the down payment of the license-option contract with Indivior PLC for AEF0117, based on the incurred costs of the phase 2b during the first half of 2022. As a reminder, €7.921 million had been recognized when the contract was signed in 2021.

As of June 30, 2022, the financial result shows a loss of € (5.710) million against a profit of €497 thousand as of June 30, 2021. This change mainly reflects the impact of the conversion of convertible bonds on the date of the Aelis Farma’s initial public offer (IPO). This non-cash financial expense corresponds to the difference between the fair value of the securities issued, based on the stock market price on the date of listing, and the nominal value of the initial debt.

The net result shows a loss of € (10.352) million for the first half of 2022 compared to a profit of €3.781 million for the previous financial year.

Cash flow

Financial structure

The financial structure of Aelis Farma was strengthened during the first half of 2022 by:

• the net proceeds of €22.5 million from the capital increase carried out on the occasion of Aelis Farma’s initial public offering in compartment B of Euronext Paris;
• the conversion into capital of the convertible bonds held by Inserm Transfert Initiative and the Nouvelle Aquitaine Region, leading to a reduction of €3.663 million in gross debt, which decreased from €7.917 million to €4.254 million; and
• income from operating activities related to the license option agreement with Indivior PLC. The positive evolution of this cash in dollars allowed the recognition of a foreign exchange gain of €0.9 million.

Aelis Farma believes that its current cash level makes it possible, according to its forecast, to finance its development in accordance with the strategy presented during the IPO at least up to the end of 2024.

Highlights of the first half of 2022

Inclusion of the first patient in the phase 2b study with AEF0117

At the beginning of June, Aelis Farma announced the recruitment of the first patient in the phase 2b study with AEF0117, its most advanced “CB₁-SSi” drug candidate, for the treatment of cannabis addiction. The study, coordinated by Prof. Frances Levin of Columbia University, should include approximately 330 patients in 9 participating clinical centers in the United States. The AEF017 program benefits from overall funding from the North American National Institute on Drug Abuse of the National institute of Health (NIDA-NIH) of $7.8 million, including $4.5 million allocated at the end of 2021 for this new phase of development.

Participation in the T21RS international conference

Aelis Farma participated in the 4th international conference organized by the Trisomy 21 Research Society (T21RS), which was held in Long Beach, California from June 9 to 12, 2022.

Pier Vincenzo Piazza, Co-founder and CEO of Aelis Farma, presented the drug candidate AEF0217 during a session entitled “AEF0217: a new approach for the treatment of cognitive impairment in Down syndrome”.

The Trisomy 21 Research Society (T21RS) is the leading international scientific society dedicated to translational and clinical research on Down syndrome (Trisomy 21). One of its main activities is to support the dissemination and discussion of the latest advances in clinical and preclinical research in this area through a series of biennial meetings. T21RS also connects researchers and patient & families associations which have very active interactions with the society.

Strategy & Outlook

Over the coming months, thanks to the strength of its financial position, Aelis Farma intends to pursue the development of its various assets, in accordance with the strategy presented at the time of its IPO:

Developing AEF0117 to address the adverse effects of excessive cannabis use

The phase 2b clinical trial with AEF0117 is continuing with a good level of recruitment and the results of the study are expected in 2024. If this study proves to be positive, Aelis Farma and its partner Indivior PLC intend to start phase 3 studies in late 2024 or early 2025, in order to quickly obtain approval for AEF0117 in the United States and Europe.

Develop AEF0217 to treat various cognitive deficits, including those of Down syndrome (Trisomy 21)

AEF0217 has completed the recruitment of its phase 1 program in healthy volunteers. The audited results of these studies are expected in the coming weeks. The launch of a phase 1/2 clinical study in subjects with Down syndrome is planned for the 4^th quarter of 2022. This study will investigate the safety and pharmacokinetics of AEF0217 in Down syndrome individuals and could provide the first indications about the activity in the first half of 2023. The development of AEF0217 as a treatment of the cognitive deficits associated with Trisomy 21 has received a €6 million grant from the European community (Project ICOD N° 899986).

Aelis Farma also works on the extension of the development of AEF0217 for the treatment of other cognitive deficits such as the ones associated to Fragile X syndrome or aging, for which AEF0217 has been shown to be effective in preclinical models.

Identify new drug candidates

Given the involvement of the CB₁ receptor in numerous pathologies, Aelis Farma is pursuing the characterization of its diversified and exclusive library of CB₁-SSi in order to identify new candidate drugs to address other brain diseases dependent on the CB₁ receptor.

About AELIS FARMA

Founded in 2013, Aelis Farma is a biopharmaceutical company that is developing a new class of drugs, the Signaling Specific inhibitors of the CB₁ receptor of the endocannabinoid system (CB₁-SSi). These new molecular entities hold great potential in the treatment of many brain diseases. CB₁-SSi were developed by Aelis Farma on the basis of the discovery of a new natural defense mechanism of the brain made by the team of Dr. Pier Vincenzo Piazza, CEO of the Company, when he was Director of the Inserm Magendie Neurocenter in Bordeaux. For these discoveries, Dr. Piazza was awarded the Inserm Grand Prix and the Grand Prix of Neurology of the French Academy of Sciences, which are among the most prestigious French prizes in medicine and neurology.

Aelis Farma is developing two first-in-class drug candidates that are at the clinical stage, AEF0117 and AEF0217, and has a portfolio of innovative CB₁-SSi for the treatment of other diseases associated with a dysregulation of the activity of the CB₁ receptor.

AEF0117, which targets the disorders due to excessive cannabis use (addiction and psychosis), has shown indications of efficacy in a phase 2a clinical trial and has entered a phase 2b clinical trial in the United States in Q2 2022. Aelis Farma has an exclusive option-license agreement with Indivior PLC, a leading pharmaceutical company in the treatment of addiction, for the development and commercialization of AEF0117 for disorders due to excessive cannabis use. As part of this agreement, Aelis Farma received $30 million (option payment). If Indivior exercises the license option at the end of the phase 2b, Aelis Farma will receive a $100 million license fee (potentially in 2024) and up to $340 million in additional payments contingent on the achievement of development, regulatory and commercial milestones as well as, royalties on net sales of AEF0117 ranging between 12% and 20%.

AEF0217, which targets various cognitive disorders including those associated with Down syndrome, has finished recruitments of its phase 1 program in healthy volunteers and will start in Q4 2022 a phase 1/2 study in Down syndrome subjects. This compound has undergone an extensive preclinical proof-of-concept program using highly innovative assessing cognitive functions. In this context, AEF0217 has demonstrated its ability to completely reverse cognitive deficits observed in several animal models of neurodevelopmental disorders, such as Down syndrome and Fragile X syndrome, as well as in models of certain cognitive deficits associated with aging.

Based in Bordeaux, within the Magendie Neurocenter, Aelis Farma has a team of 23 highly qualified employees and has benefited from investments from the Nouvelle-Aquitaine Region, Inserm Transfert Initiative, Bpifrance, regional funds ACI, NACO and Aqui-invest and IRDI Capital Investissement.

For more information: www.aelisfarma.com

ISIN: FR0014007ZB4

Ticker: AELIS

B Compartment of Euronext Paris

Disclaimer

Forward-looking statements

Some information contained in this press release are forward-looking statements, not historical data. These forward-looking statements are based on current beliefs, expectations, and assumptions, including, but not limited to, assumptions about Aelis Farma’s current and future strategy and the environment in which Aelis Farma operates. They involve known and unknown risks, uncertainties, and other factors, which may cause actual results, performance or achievements, or industry results or other events, to differ materially from those described or implied by such forward-looking statements. These risks and uncertainties include those set out and detailed in Chapter 3 “Risk Factors” of Aelis Farma’s registration document approved by the Autorité des marchés financiers on 14 January 2022 under number I.22-003.

These forward-looking statements are made only as of the date of this press release and Aelis Farma expressly disclaims any obligation or undertaking to release any updates or corrections to the forward-looking statements included in this press release to reflect any change in expectations or events, conditions or circumstances on which any such forward-looking statement is based. Forward-looking information and statements are not guarantees of future performance and are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond Aelis Farma’s control. Actual results could differ materially from those described in, or implied or projected by, forward-looking information and statements.

¹The half-year accounts were approved by the Board of Directors on September 23, 2022. The limited review of these accounts has been completed. The auditors’ limited review report is in the process of being issued.