ANEB Anebulo Pharmaceuticals Inc.

7.08
+0.32  (+5%)
Previous Close 6.76
Open 6.91
52 Week Low 6.31
52 Week High 9.33
Market Cap $165,279,534
Shares 23,344,567
Float 4,256,680
Enterprise Value $163,475,774
Volume 3,944
Av. Daily Volume 2,791
Stock charts supplied by TradingView

Upcoming Catalysts

Drug Stage Catalyst Date
Anebulo
Cannabinoid overdose
Phase 2
Phase 2
Premium membership is required to view catalyst dates, analyst ratings, earnings dates and cash burn data. Click here to unlock and sign up to a 14-day FREE TRIAL.

Latest News

  1. Anebulo Pharmaceuticals, Inc. (NASDAQ:ANEB), a clinical-stage biopharmaceutical company developing novel solutions for people suffering from acute cannabinoid intoxication and substance addiction, today announced the completion of finished product manufacturing of its lead drug ANEB-001 for use in the Company's upcoming Phase 2 clinical study. In compliance with all current Good Manufacturing Practice requirements, ANEB-001's active pharmaceutical ingredient was delivered to its contract manufacturer and filled into 10mg and 50mg capsules for finished product.

    "Completion of manufacturing ANEB-001 capsules is a critical step in advancing the development of our drug candidate for the treatment of acute cannabis intoxication," stated Daniel…

    Anebulo Pharmaceuticals, Inc. (NASDAQ:ANEB), a clinical-stage biopharmaceutical company developing novel solutions for people suffering from acute cannabinoid intoxication and substance addiction, today announced the completion of finished product manufacturing of its lead drug ANEB-001 for use in the Company's upcoming Phase 2 clinical study. In compliance with all current Good Manufacturing Practice requirements, ANEB-001's active pharmaceutical ingredient was delivered to its contract manufacturer and filled into 10mg and 50mg capsules for finished product.

    "Completion of manufacturing ANEB-001 capsules is a critical step in advancing the development of our drug candidate for the treatment of acute cannabis intoxication," stated Daniel Schneeberger, M.D., Chief Executive Officer of Anebulo. "With more than 1.7 million cannabinoid-related emergency department visits in 2018 and the number of visits growing by an estimated 15% annually, we believe ANEB-001 addresses a significant unmet need. We are on track to commence our Phase 2 proof-of-concept study in the coming weeks, which is ahead of schedule, and expect initial topline results from the first cohort in the first half of next year."

    About ANEB-001

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

    ANEB-001 is being developed to be administered as an oral treatment, reaches potentially therapeutic blood levels within 30 minutes and is believed to rapidly reverse the signs and symptoms of cannabinoid overdose in as little as one hour. Anebulo believes there is a low likelihood of drug-drug interactions as preclinical testing demonstrated that ANEB-001 does not inhibit the metabolic cytochromes 1A2, 2C9, 2C19, 2D6 and 3A4 at pharmacologically relevant concentrations. No product is approved for acute cannabinoid intoxication and Anebulo is not aware of any competing products to reverse the symptoms of cannabinoid intoxication that are further along in the development process than ANEB-001.

    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 intended to reverse the negative effects of acute cannabinoid intoxication within one hour of administration. Clinical trials completed to date have shown that ANEB-001 is rapidly absorbed, well tolerated and leads to weight loss, an effect that is consistent with central cannabinoid receptor type 1 antagonism. For further information about 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, 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 recent registration statement on Form S-1 and in 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.

    View Full Article Hide Full Article
  2. Anebulo Pharmaceuticals, Inc. (NASDAQ:ANEB) ("Anebulo" or the "Company"), a clinical-stage biopharmaceutical company developing novel solutions for people suffering from acute cannabinoid intoxication and substance addiction, today announced that management will be participating in the H.C. Wainwright 23rd Annual Global investment Conference being held virtually on September 13-15, 2021. Management will deliver a company presentation and will be available for one-on-one meetings with investors. The recorded presentation will be available on demand beginning Monday, September 13th on the Investors section of Anebulo's website.

    About Anebulo Pharmaceuticals, Inc.

    Anebulo Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company developing…

    Anebulo Pharmaceuticals, Inc. (NASDAQ:ANEB) ("Anebulo" or the "Company"), a clinical-stage biopharmaceutical company developing novel solutions for people suffering from acute cannabinoid intoxication and substance addiction, today announced that management will be participating in the H.C. Wainwright 23rd Annual Global investment Conference being held virtually on September 13-15, 2021. Management will deliver a company presentation and will be available for one-on-one meetings with investors. The recorded presentation will be available on demand beginning Monday, September 13th on the Investors section of Anebulo's website.

    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 intended to reverse the negative effects of acute cannabinoid intoxication within one hour of administration. Clinical trials completed to date have shown that ANEB-001 is rapidly absorbed, well tolerated and leads to weight loss, an effect that is consistent with central cannabinoid receptor type 1 antagonism. For further information about Anebulo, please visit www.anebulo.com.

    View Full Article Hide Full Article
  3. Anebulo Pharmaceuticals, Inc. (NASDAQ:ANEB) ("Anebulo" or the "Company"), a clinical-stage biopharmaceutical company developing novel solutions for people suffering from acute cannabinoid intoxication and substance addiction, today announced the formation of a Scientific Advisory Board (SAB) to advise on the Company's clinical development programs and its product pipeline. The founding co-chairs are Andrew Monte, M.D., Ph.D. and Arjun Chanmugam, M.D., both recognized leaders in emergency medicine.

    "I am pleased to announce the formation of Anebulo's Scientific Advisory Board with co-chairs Drs. Monte and Chanmugam, both of whom bring significant expertise in emergency medicine and medical toxicology," stated Daniel Schneeberger, M.D., Chief…

    Anebulo Pharmaceuticals, Inc. (NASDAQ:ANEB) ("Anebulo" or the "Company"), a clinical-stage biopharmaceutical company developing novel solutions for people suffering from acute cannabinoid intoxication and substance addiction, today announced the formation of a Scientific Advisory Board (SAB) to advise on the Company's clinical development programs and its product pipeline. The founding co-chairs are Andrew Monte, M.D., Ph.D. and Arjun Chanmugam, M.D., both recognized leaders in emergency medicine.

    "I am pleased to announce the formation of Anebulo's Scientific Advisory Board with co-chairs Drs. Monte and Chanmugam, both of whom bring significant expertise in emergency medicine and medical toxicology," stated Daniel Schneeberger, M.D., Chief Executive Officer of Anebulo. "We look forward to their contributions to Anebulo and to adding additional SAB members as we progress ANEB-001, our lead candidate for the treatment of acute cannabis intoxication, into a single-site Phase 2 proof-of-concept study. This study is expected to commence in the fourth quarter of 2021 with results in the first half of next year."

    "With the increased liberalization of cannabis policy for medical and recreational use in Colorado, emergency department visits attributable to the drug have increased more than four-fold. Other states and countries are experiencing a similar rise in acute care visits as cannabis availability increases in their communities. This has created a pressing need for a treatment for the adverse effects of acute cannabis intoxication," noted Dr. Monte.

    "I am delighted to serve in a role where we might make a meaningful and positive impact on safety and quality of life for those patients who are at risk for intoxication of tetrahydrocannabinol, or THC, an active ingredient in marijuana. In addition, the SAB will explore other indications to expand the market opportunity for Anebulo's promising cannabinoid antagonist," stated Dr. Chanmugam.

    Andrew Monte, M.D., Ph.D., is trained as a medical toxicologist and has a Ph.D. in clinical sciences with a focus on genetics. Dr. Monte conducts research on novel psychoactive substances and precision medicine. He is an Associate Professor of Emergency Medicine & Medical Toxicology at the University of Colorado School of Medicine and an attending physician consultant at the Children's Hospital Colorado, Denver Health & Hospital Authority and the Rocky Mountain Poison & Drug Center. Dr. Monte is particularly interested in drug-drug and drug-gene interactions with a goal of improving emergency therapies through genomic and metabolomic methodologies. His work in substance abuse examines the public health effects of cannabis liberalization, drug detection and genomic variability in patient illicit drug responses. His work is funded by institutional grants, the National Institute on Drug Abuse, the National Institute of General Medical Sciences and the Department of Defense.

    Arjun Chanmugam, M.D. is a professor and Vice-Chair of Emergency Medicine at the Johns Hopkins University School of Medicine. In addition, he serves as the Chair of Emergency Medicine at the Johns Hopkins Bayview Medical Center and the Chief Medical Officer for Emergency Medicine for Johns Hopkins Medicine. Dr. Chanmugam is the editor of a number of textbooks and scholarly papers. He remains actively involved in healthcare innovation and integration. He continues to care for patients, in addition to performing his roles as an administrator and educator.

    About ANEB-001

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

    ANEB-001 is being developed to be administered as an oral treatment in the form of a pill, capsule or tablet, reaches potentially therapeutic blood levels within 30 minutes and is believed to rapidly reverse the signs and symptoms of cannabinoid overdose in as little as one hour. Anebulo believes there is a low likelihood of drug-drug interactions as preclinical testing demonstrated that ANEB-001 does not inhibit the metabolic cytochromes 1A2, 2C9, 2C19, 2D6 and 3A4 at pharmacologically relevant concentrations. No product is approved for acute cannabinoid intoxication and Anebulo is not aware of any competing products to reverse the symptoms of cannabinoid intoxication that are further along in the development process than ANEB-001.

    About Acute Cannabinoid Intoxication

    More than 140 million people are believed to use cannabis worldwide. In the U.S., there were approximately 1.7 million cannabinoid-related emergency department (ED) visits in 2018 and the number of visits is growing by an estimated 15% annually. ED visits are catalyzed by excessive use in adults and inadvertent ingestions in small children. Synthetic cannabinoids are the most abused synthetic drug and the second most abused drug among adolescents. The duration of acute cannabinoid intoxication is approximately 2-6 hours for inhalation and 8-12 hours for ingestion.

    The symptoms of acute cannabinoid intoxication include decreased systemic vascular resistance, elevated heart rate, decreased intraocular pressure, nystagmus, conjunctival injection, lethargy, decreased concentration and generalized psychomotor impairment. Synthetic cannabinoid toxicity symptoms include sympathomimetic toxicity, psychosis and agitation, as well as seizures and sedation. Severe cases have experienced hyperthermia, rhabdomyolysis and renal failure. In children, acute intoxication can lead to decreased muscle coordination, lethargy, seizures, dulled senses and death.

    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 intended to reverse the negative effects of acute cannabinoid intoxication within one hour of administration. Clinical trials completed to date have shown that ANEB-001 is rapidly absorbed, well tolerated and leads to weight loss, an effect that is consistent with central cannabinoid receptor type 1 antagonism. For further information about 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, 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 recent registration statement on Form S-1 and in 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.

    View Full Article Hide Full Article
  4. Anebulo Pharmaceuticals, Inc. (NASDAQ:ANEB) ("Anebulo" or the "Company"), a clinical-stage biotechnology company developing novel solutions for people suffering from cannabinoid intoxication and substance addiction, today reported recent business highlights and announced financial results for the fiscal year 2021 third quarter, ended March 31, 2021.

    Business highlights for the quarter and recent weeks include the following:

    • Completed an initial public offering (IPO) of 3,078,224 shares of common stock at $7.00 per share resulting in gross cash proceeds to the Company of approximately $20.2 million before deducting underwriting discounts, commissions and expenses. On May 7, 2021, the Company's common stock began trading on the Nasdaq Capital…

    Anebulo Pharmaceuticals, Inc. (NASDAQ:ANEB) ("Anebulo" or the "Company"), a clinical-stage biotechnology company developing novel solutions for people suffering from cannabinoid intoxication and substance addiction, today reported recent business highlights and announced financial results for the fiscal year 2021 third quarter, ended March 31, 2021.

    Business highlights for the quarter and recent weeks include the following:

    • Completed an initial public offering (IPO) of 3,078,224 shares of common stock at $7.00 per share resulting in gross cash proceeds to the Company of approximately $20.2 million before deducting underwriting discounts, commissions and expenses. On May 7, 2021, the Company's common stock began trading on the Nasdaq Capital Market under the symbol ANEB.
    • Management believes IPO net proceeds of $19.0 million provide adequate funding for the Company's planned business operations and clinical studies through December 31, 2022.
    • Anebulo remains on track to commence a Phase 2 proof-of-concept clinical trial with ANEB-001 for the treatment of cannabinoid overdose in the fourth quarter of 2021 with anticipated topline results in the first half of 2022.
    • The planned Phase 2 study will take place at a single site in the Netherlands. The study is expected to enroll 100 healthy volunteers with each to receive 10 mg of THC orally, and then randomized to one of three doses of ANEB-001 or placebo.
    • The study has been approved by the necessary regulatory and ethics committee and contract research organization capacity has been secured.

    Management Commentary

    "The pricing of our IPO in May was a tremendous milestone for Anebulo as the capital we raised allows us to advance our lead drug candidate ANEB-001 for the treatment of patients with cannabinoid intoxication," stated Daniel Schneeberger, MD, Chief Executive Officer of Anebulo. "There are currently no effective therapies for the negative effects of cannabinoid intoxication and the unmet need to address this issue is growing in lockstep with an increasing number of states legalizing cannabis for medical and recreational use. The number of cannabis-associated emergency department visits has increased by 15% annually since cannabis legalization began in the U.S. and reached 1.7 million in 2018 according to our analysis of National Emergency Department Sample. Overdoses from the ingestion of edible products and synthetic cannabinoids and accidental pediatric overdoses, in particular, are indications with high unmet medical need. We believe ANEB-001 has the ability to reverse these adverse symptoms within one hour of administration."

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

    ANEB-001 is being developed to be administered as an oral treatment in the form of a pill, capsule or tablet, reaches potentially therapeutic blood levels within 30 minutes and is believed to rapidly reverse the signs and symptoms of cannabinoid overdose in as little as one hour. Anebulo believes there is a low likelihood of drug-drug interactions as preclinical testing demonstrated that ANEB-001 does not inhibit the metabolic cytochromes 1A2, 2C9, 2C19, 2D6 and 3A4 at pharmacologically relevant concentrations. Anebulo is not aware of any competing products to reverse the symptoms of cannabinoid intoxication that are further along in the development process than ANEB-001.

    Third Quarter Financial Results

    • Operating expenses totaled $552,131 in the third quarter of fiscal 2021. The Company did not have any operations in the comparable prior-year period.
    • Net loss in the third quarter of fiscal 2021 was $555,832, or $0.04 per share on 12,982,500 weighted-average common shares outstanding. Net loss attributable to common shareholders was $8,764,225, or $0.69 per share, including a deemed dividend to preferred shareholders of $8,208,393. The Company did not have any operations in the comparable prior-year period. The shares outstanding have been adjusted to reflect the 6:1 stock split effected just prior to the Company's May 6, 2021 IPO.
    • Cash and cash equivalents were $3.3 million as of March 31, 2021.
    • On May 6, 2021, Anebulo priced its IPO and received net proceeds of approximately $19.0 million, including the underwriters' overallotment. Annual operating expenses are approximately $3 million.
    • Today's delayed release of the financial results for the third quarter of fiscal 2021 is in compliance with the SEC-established deadline of 45 days after an IPO.

    About Anebulo Pharmaceuticals, Inc.

    Anebulo Pharmaceuticals, Inc. is a clinical-stage biotechnology company developing novel solutions for people suffering from cannabinoid overdose and substance addiction. Its lead product candidate, ANEB-001, is intended to reverse the negative effects of cannabinoid overdose within one hour of administration. Clinical trials completed to date have shown that ANEB-001 is rapidly absorbed, well tolerated and leads to weight loss, an effect that is consistent with central cannabinoid receptor type 1 antagonism. For further information about 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, 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 recent registration statement on Form S-1 and in 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.

    Anebulo Pharmaceuticals, Inc.

    Balance Sheets

     

     

    March 31, 2021

     

     

    June 30, 2020

     

     

    (unaudited)

     

     

    (audited)

     

    Assets

     

     

     

     

     

     

    Current assets:

     

     

     

     

     

     

    Cash and cash equivalents

     

    $

    3,307,083

     

     

    $

    3,024,980

     

    Receivable - related party

     

     

    -

     

     

     

    3,500

     

    Prepaid expenses and other current assets

     

     

    591,662

     

     

     

    -

     

    Total current assets

     

     

    3,898,745

     

     

     

    3,028,480

     

    Deferred offering costs

     

     

    392,730

     

     

     

    -

     

    Total assets

     

    $

    4,291,475

     

     

    $

    3,028,480

     

     

     

     

     

     

     

     

     

     

    Liabilities, convertible preferred stock and stockholders' deficit

     

     

     

     

     

     

     

     

    Current liabilities:

     

     

     

     

     

     

     

     

    Accounts payable

     

    $

    82,027

     

     

    $

    -

     

    Accrued expenses

     

     

    211,139

     

     

     

    22,579

     

    Promissory notes - related party

     

     

    -

     

     

     

    201,286

     

    Total current liabilities

     

     

    293,166

     

     

     

    223,865

     

    Warrant liability

     

     

    10,458,393

     

     

     

    -

     

    Total Liabilities

     

     

    10,751,559

     

     

     

    223,865

     

     

     

     

     

     

     

     

     

     

    Commitments and contingencies

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

    Series A convertible preferred stock, $0.0001 par value; 8,943,906 shares authorized;

     

     

     

     

     

     

     

     

    2,047,500 shares issued and outstanding at March 31, 2021 and June 30, 2020

     

     

    2,975,752

     

     

     

    2,975,752

     

     

     

     

     

     

     

     

     

     

    Stockholders' deficit:

     

     

     

     

     

     

     

     

    Common stock, $0.001 par value; 22,800,000 shares authorized; 12,982,500 and 12,000,000

     

     

     

     

     

     

     

     

    shares issued and outstanding at March 31, 2021 and June 30, 2020, respectively

     

     

    12,983

     

     

     

    12,000

     

    Additional paid-in capital

     

     

    83,526

     

     

     

    -

     

    Accumulated deficit

     

     

    (9,532,345

    )

     

     

    (183,137

    )

    Total stockholders' deficit

     

     

    (9,435,836

    )

     

     

    (171,137

    )

    Total liabilities, convertible preferred stock, and stockholders' deficit

     

    $

    4,291,475

     

     

    $

    3,028,480

     

    Anebulo Pharmaceuticals, Inc.

    Statements of Operations

     

     

     

    Three months ended

     

     

    Nine months ended

     

     

     

    March 31, 2021

     

     

    March 31, 2021

     

    Research and development

     

    $

    273,038

     

     

    $

    463,306

     

    General and administrative

     

     

    279,093

     

     

     

    665,742

     

    Total operating expenses

     

     

    552,131

     

     

     

    1,129,048

     

    Other expense:

     

     

     

     

     

     

     

     

    Interest expense

     

     

    3,701

     

     

     

    11,767

     

    Loss from operations before taxes

     

     

    (555,832

    )

     

     

    (1,140,815

    )

    Income tax expense

     

     

    -

     

     

     

    -

     

    Net loss

     

    $

    (555,832

    )

     

    $

    (1,140,815

    )

    Deemed dividend

     

     

    (8,208,393

    )

     

     

    (8,208,393

    )

    Net loss attributable to common stockholders

     

    $

    (8,764,225

    )

     

    $

    (9,349,208

    )

     

     

     

     

     

     

     

     

     

    Weighted average common shares outstanding, basic and diluted

     

     

    12,982,500

     

     

     

    12,656,310

     

    Net loss per share, basic and diluted

     

    $

    (0.69

    )

     

    $

    (0.74

    )

     

    View Full Article Hide Full Article
View All Anebulo Pharmaceuticals Inc. News