ANEB Anebulo Pharmaceuticals Inc.

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Open
52 Week Low 4.4
52 Week High 9.33
Market Cap $163,411,969
Shares 23,344,567
Float 2,363,974
Enterprise Value $161,141,318
Volume 24
Av. Daily Volume 4,268
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Anebulo (ANEB-001)
Cannabinoid overdose
Phase 2
Phase 2
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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 abuse, announces that management will present a company overview at the H.C. Wainwright BioConnect Virtual Conference being held January 10-13, 2022. A webcast of the presentation will be available on-demand beginning January 10, 2022 at 7:00 a.m. Eastern time 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 abuse. Its lead product candidate, ANEB-001…

    Anebulo Pharmaceuticals, Inc. (NASDAQ:ANEB), a clinical-stage biopharmaceutical company developing novel solutions for people suffering from acute cannabinoid intoxication and substance abuse, announces that management will present a company overview at the H.C. Wainwright BioConnect Virtual Conference being held January 10-13, 2022. A webcast of the presentation will be available on-demand beginning January 10, 2022 at 7:00 a.m. Eastern time 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 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) with good oral bioavailability and brain penetration (rat brain:plasma ratio of approximately 1.5). Clinical trials completed to date have shown that ANEB-001 is rapidly absorbed, well tolerated, and may lead to weight loss, an effect that is consistent with CB1 antagonism in the central nervous system. For further information about Anebulo, please visit www.anebulo.com.

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  2. Anebulo Pharmaceuticals, Inc. (NASDAQ:ANEB), a clinical-stage biopharmaceutical company developing novel solutions for people suffering from acute cannabinoid intoxication and substance abuse, announced today that it has appointed Scott L. Anderson as Head of Investor Relations and Public Relations, effective immediately.

    In this position, Mr. Anderson will report directly to Rex Merchant, Anebulo's Chief Financial Officer. Mr. Anderson will be responsible for Anebulo's global investor relations and public relations programs. He serves as the primary spokesperson and point of contact with the analyst and investment community and is also responsible for the timely dissemination of information and data to these important stakeholders.

    Mr. Anderson…

    Anebulo Pharmaceuticals, Inc. (NASDAQ:ANEB), a clinical-stage biopharmaceutical company developing novel solutions for people suffering from acute cannabinoid intoxication and substance abuse, announced today that it has appointed Scott L. Anderson as Head of Investor Relations and Public Relations, effective immediately.

    In this position, Mr. Anderson will report directly to Rex Merchant, Anebulo's Chief Financial Officer. Mr. Anderson will be responsible for Anebulo's global investor relations and public relations programs. He serves as the primary spokesperson and point of contact with the analyst and investment community and is also responsible for the timely dissemination of information and data to these important stakeholders.

    Mr. Anderson will build on Anebulo's current investor relations and public relations programs to grow and diversify the Company's shareholder base as well as to enhance its communications with shareholders and other stakeholders. Scott will work closely with the management team to further develop the company's internal and external communications with a focus on strategy, branding, social media presence and investor communications.

    Mr. Anderson brings more than 20 years of public company experience to Anebulo, having served in various investor relations and corporate communications roles at such companies as Qualcomm, Qorvo (formerly RF Micro Devices), Actavis plc (formerly Watson Pharmaceuticals), and O2Micro International Limited.

    Commenting on the appointment, Dr. Daniel Schneeberger, CEO, said: "We are extremely pleased to welcome Scott to the Anebulo Team. His experience and insights make him ideally suited to support the continued development of our investor relations program and goals. Based on our plans to report topline results from our ongoing Phase 2 trial in the first half of the year, it is a great time to bolster our investor relations program and ensure best practices to drive shareholder value."

    Mr. Anderson added, "I'm delighted to be joining Anebulo at this unique and exciting time. I look forward to assisting Anebulo to communicate the Company's strategic initiatives and performance drivers to the financial community and its key stakeholders."

    Mr. Anderson earned a B.A. degree in Communication Arts & Sciences from the Annenberg School for Communication and Journalism at the University of Southern California.

    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. 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) with good oral bioavailability and brain penetration (rat brain:plasma ratio of approximately 1.5). Clinical trials completed to date have shown that ANEB-001 is rapidly absorbed, well tolerated, and may lead to weight loss, an effect that is consistent with CB1 antagonism in the central nervous system. 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 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.

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  3. Anebulo Pharmaceuticals, Inc. (NASDAQ:ANEB), a clinical-stage biopharmaceutical company developing novel solutions for people suffering from acute cannabinoid intoxication and substance abuse, has named Simon Allen as Chief Executive Officer and a member of the company's Board of Directors, effective February 1st, 2022. Mr. Allen succeeds Daniel Schneeberger, MD, who has resigned as CEO and as a Director as of that same date.

    Since March 2019, Mr. Allen has served as Chief Business Officer of Ambrx Biopharma Inc. (NYSE:AMAM), a position he previously held from 2010 through 2015. Ambrx is an engineered precision biologics company developing antibody-drug conjugate and immune-oncology conjugate candidates for breast cancer, gastric cancer and…

    Anebulo Pharmaceuticals, Inc. (NASDAQ:ANEB), a clinical-stage biopharmaceutical company developing novel solutions for people suffering from acute cannabinoid intoxication and substance abuse, has named Simon Allen as Chief Executive Officer and a member of the company's Board of Directors, effective February 1st, 2022. Mr. Allen succeeds Daniel Schneeberger, MD, who has resigned as CEO and as a Director as of that same date.

    Since March 2019, Mr. Allen has served as Chief Business Officer of Ambrx Biopharma Inc. (NYSE:AMAM), a position he previously held from 2010 through 2015. Ambrx is an engineered precision biologics company developing antibody-drug conjugate and immune-oncology conjugate candidates for breast cancer, gastric cancer and other solid tumors.

    "I am so very proud of all Anebulo has achieved over the past 18 months, including building out a highly effective team, securing new intellectual property protection, preparing and starting a proof-of-concept clinical trial, advancing regulatory discussions with the U.S. FDA and securing financing through a successful IPO," said Dr. Schneeberger. "Simon is a tremendous leader with significant commercial and business development experience, which are the most relevant skills for Anebulo at this stage. Having taken Anebulo through its start-up phase, I now plan to focus full time on my investment fund. I thank the Anebulo Board and all its employees for their collaboration and friendship."

    "Anebulo is ideally positioned to address the significant harm and burden of substance abuse. Our lead product, ANEB-001, has the potential to rapidly reverse the effects of acute cannabinoid intoxication, a relatively unknown yet serious affliction that sends more than 5,000 Americans to the hospital emergency department every day. Unfortunately, this number is expected to increase rapidly with legalized marijuana and access to substances that have five times the THC concentration of regular marijuana," said Mr. Allen. "We are currently focused on developing the first FDA-approved therapy for emergency department physicians to treat the serious and sometimes fatal effects of cannabinoid intoxication. I am very impressed with the clear mechanism of action of ANEB-001 and the company's successful efforts to navigate the clinical, regulatory, CMC and intellectual property aspects of this opportunity. I also believe 2022 will be another transformative year for Anebulo given our plans to report topline results from our ongoing Phase 2 trial in the first half of the year. I am honored and grateful for the opportunity to lead such a talented team and look forward to taking Anebulo to the next level."

    Joseph Lawler, MD, PhD, Chairman of the Anebulo Board of Directors, added, "Simon is a tremendously accomplished business executive who brings to Anebulo the skills, experience and relationships necessary to advance our business plan rapidly and efficiently. I welcome him to our company and to our Board of Directors. Also, I would like to thank Daniel for leading Anebulo through a time of great progress. All of us at Anebulo wish him well in his future professional endeavors."

    At Ambrx, Mr. Allen established multiple partnerships with companies including Bristol Myers Squibb, Pfizer, Merck, Eli Lilly, Astellas, BeiGene and Sino Biopharma that have generated more than $270 million in revenue with a potential $1 billion in future milestones and royalties. From 2016 to 2018 he was Chief Executive Officer of CohBar, where he transitioned the company from the preclinical to the clinical stage and managed the listing of its shares on Nasdaq, with subsequent inclusion in the Russell 2000 Index. Earlier Mr. Allen held various management, commercial and business development positions at Nuvelo, Skyepharma, CovX and Kalypsys.

    Mr. Allen started his career as a research biologist in the antiviral group at Gilead Sciences before working in healthcare equity research and investment banking in the U.S. and Australia. He holds a BSc in biochemistry and genetics from the University of Sydney and an MBA from the Australian Graduate School of Management.

    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. 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) with good oral bioavailability and brain penetration (rat brain:plasma ratio of approximately 1.5). Clinical trials completed to date have shown that ANEB-001 is rapidly absorbed, well tolerated, and may lead to weight loss, an effect that is consistent with CB1 antagonism in the central nervous system. 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 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.

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  4. Affirms expectations for initial topline results in 1H 2022

    Recent FDA pre-IND meeting provides valuable guidance on U.S. regulatory path; company expects to submit IND in 1Q 2022

    Anebulo Pharmaceuticals, Inc. (NASDAQ:ANEB), a clinical-stage biopharmaceutical company developing novel solutions for people suffering from acute cannabinoid intoxication and substance abuse, announces that the first patient has been dosed in a Phase 2 proof-of-concept clinical study investigating ANEB-001 as a potential treatment for acute cannabinoid intoxication.

    In addition, Anebulo recently held a pre-IND (Investigational New Drug) meeting with the U.S. Food and Drug Administration (FDA) during which the company received valuable guidance regarding the clinical…

    Affirms expectations for initial topline results in 1H 2022

    Recent FDA pre-IND meeting provides valuable guidance on U.S. regulatory path; company expects to submit IND in 1Q 2022

    Anebulo Pharmaceuticals, Inc. (NASDAQ:ANEB), a clinical-stage biopharmaceutical company developing novel solutions for people suffering from acute cannabinoid intoxication and substance abuse, announces that the first patient has been dosed in a Phase 2 proof-of-concept clinical study investigating ANEB-001 as a potential treatment for acute cannabinoid intoxication.

    In addition, Anebulo recently held a pre-IND (Investigational New Drug) meeting with the U.S. Food and Drug Administration (FDA) during which the company received valuable guidance regarding the clinical development of ANEB-001 in the U.S. Importantly, the FDA noted that a challenge model whereby subjects are exposed to THC in a controlled clinical setting may be acceptable to investigate primary efficacy, which would allow for the more efficient development of ANEB-001. Further, the FDA suggested that Anebulo submit a model-informed drug development (MIDD) paired-meeting request.

    "The initiation of our Phase 2 study in the Netherlands represents a significant milestone for Anebulo. We continue to anticipate reporting initial topline results from Part A of this trial in the first half of 2022, as we closely monitor the impact of COVID-19. Despite the recently announced national lockdown in the Netherlands, our CRO is continuing to screen and enroll patients," stated Daniel Schneeberger, M.D., Chief Executive Officer of Anebulo.

    "Additionally, we are pleased with the guidance provided by the FDA regarding ANEB-001's clinical and regulatory path in the U.S. We were able to rapidly incorporate the FDA's feedback into the design of the current Phase 2 trial to make the data generated in Europe as relevant as possible for a potential future NDA submission. We expect to file an IND with the FDA during the first quarter of 2022," he added. "There is a large and growing need to treat acute cannabinoid intoxication with 1.7 million cannabinoid-related emergency department visits in the U.S. in 2018, and we believe ANEB-001 holds potential to reverse symptoms safely and rapidly."

    The Phase 2 clinical trial is a randomized, double-blind, placebo-controlled study at a single site in the Netherlands to evaluate ANEB-001 in the inhibition of THC-induced effects. The new trial design anticipates enrolling a total of 60 patients in Part A, randomized 1:1:1 between 50mg of ANEB-001, 100mg of ANEB-001 and placebo. All participants will receive 10.5mg of THC as a challenge drug. The goal of Part A is to deliver clinical proof-of-concept that ANEB-001 can reverse the effects of THC. Part B will enroll additional cohorts and further explore the relationship between THC and ANEB-001 dose levels and clinical efficacy, and provide additional datapoints for pharmacokinetic/pharmacodynamic models. Anebulo believes the ability to quickly adapt the protocol and test additional hypotheses will save time and reduce development risk while designing future trials in 2022.

    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. 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) with good oral bioavailability and brain penetration (rat brain:plasma ratio of approximately 1.5). Clinical trials completed to date have shown that ANEB-001 is rapidly absorbed, well tolerated, and may lead to weight loss, an effect that is consistent with CB1 antagonism in the central nervous system. 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 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.

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  5. Tenaya Therapeutics, Inc. (NASDAQ:TNYA), a biotechnology company with a mission to discover, develop and deliver curative therapies that address the underlying causes of heart disease, today announced the appointments of Karah Parschauer, J.D., to its Board of Directors and of Joanna Auch as Senior Vice President of People and Culture.

    "Tenaya is at an important inflection point in our growth and maturity. We are now a public company with more than 100 employees who represent our commitment to internalize critical capabilities, including cGMP manufacturing and clinical development," said Faraz Ali, CEO of Tenaya. "Both Karah and Joanna are strong leaders who bring highly relevant strategic and operational experiences to Tenaya, and who also…

    Tenaya Therapeutics, Inc. (NASDAQ:TNYA), a biotechnology company with a mission to discover, develop and deliver curative therapies that address the underlying causes of heart disease, today announced the appointments of Karah Parschauer, J.D., to its Board of Directors and of Joanna Auch as Senior Vice President of People and Culture.

    "Tenaya is at an important inflection point in our growth and maturity. We are now a public company with more than 100 employees who represent our commitment to internalize critical capabilities, including cGMP manufacturing and clinical development," said Faraz Ali, CEO of Tenaya. "Both Karah and Joanna are strong leaders who bring highly relevant strategic and operational experiences to Tenaya, and who also add to the diversity of our Board and our leadership team. We welcome their contributions as Tenaya advances TN-201 and TYA-11631 towards INDs in 2022."

    "I am delighted to join Tenaya's Board of Directors at this important moment in the company's history," said Ms. Parschauer. "Tenaya is very well-positioned to take what the industry has learned from drug development efforts for rare diseases and gene therapies and to now apply that knowledge to advance potentially disease-modifying therapies for patients and families fighting severe genetic cardiomyopathies."

    Ms. Parschauer has nearly 20 years of relevant experience, including with biopharmaceutical companies, with proven success in corporate governance, mergers and acquisitions, and leading organizations through growth and transformation. She currently serves as Chief Legal Officer and Executive Vice President at Ultragenyx Pharmaceutical Inc., a global biopharmaceutical company advancing a diverse portfolio of approved therapies and product candidates – including gene therapies – for ultra-rare genetic diseases. Her previous experience includes over a decade in roles of increasing responsibility at Allergan plc. Ms. Parschauer began her legal career at Latham & Watkins LLP. She is currently a member of the Board of Directors for Evolus, Inc. (NASDAQ:EOLS) and Anebulo Pharmaceuticals, Inc. (NASDAQ:ANEB). Ms. Parschauer earned her B.A. from Miami University and J.D. from Harvard Law School.

    Ms. Auch brings over 15 years of human resources experience across various industries, including pharmaceutical, healthcare and technology. She most recently served as Head of Human Resources for North America at Santen, Inc., a global pharmaceutical company focused on ophthalmology, where among other responsibilities she led the human resources integration for two acquisitions. Ms. Auch earned her B.A. from San Jose State University and is a member of CSHRP, Community for Strategic HR Partnerships. She will report to Tenaya's CEO in a newly created role leading all aspects of human resources including talent acquisition and management, culture and values, compensation and benefits and organizational effectiveness.

    About Tenaya Therapeutics

    Tenaya Therapeutics is a biotechnology company committed to a bold mission: to discover, develop and deliver curative therapies that address the underlying drivers of heart disease. Founded by leading cardiovascular scientists from Gladstone Institutes and the University of Texas Southwestern Medical Center, Tenaya is developing therapies for rare genetic disorders as well as for more prevalent heart conditions through three distinct but interrelated product platforms: Gene Therapy, Cellular Regeneration and Precision Medicine. For more information, visit www.tenayatherapeutics.com.

    Forward-Looking Statements

    This press release contains forward-looking statements as that term is defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Statements in this press release that are not purely historical are forward-looking statements. Words such as "expects" and "will," and similar expressions are intended to identify forward-looking statements. Such forward-looking statements include, among other things, statements by Tenaya's chief executive officer and its board members. The forward-looking statements contained herein are based upon Tenaya's current expectations and involve assumptions that may never materialize or may prove to be incorrect. These forward-looking statements are neither promises nor guarantees and are subject to a variety of risks and uncertainties, including but not limited to: risks associated with the process of discovering, developing and commercializing drugs that are safe and effective for use as human therapeutics and operating as an early stage company; Tenaya's ability to develop, initiate or complete preclinical studies and clinical trials, and obtain approvals, for any of its product candidates; the timing, progress and results of preclinical studies for TN-201, TYA-11631 and Tenaya's other programs; Tenaya's ability to raise any additional funding it will need to continue to pursue its business and product development plans; negative impacts of the COVID-19 pandemic on Tenaya's manufacturing and operations, including preclinical studies and planned clinical trials; the timing, scope and likelihood of regulatory filings and approvals; the potential for any clinical trial results to differ from preclinical, interim, preliminary, topline or expected results; Tenaya's manufacturing, commercialization and marketing capabilities and strategy; the loss of key scientific or management personnel; competition in the industry in which Tenaya operates; Tenaya's reliance on third parties; Tenaya's ability to obtain and maintain intellectual property protection for its product candidates; general economic and market conditions; and other risks. Information regarding the foregoing and additional risks may be found in the section entitled "Risk Factors" in documents that Tenaya files from time to time with the Securities and Exchange Commission. These forward-looking statements are made as of the date of this press release, and Tenaya assumes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.

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