
<p><a href="https://biotickr.com/biotech-stocks/united-states-of-america/aneb-anebulo-pharmaceuticals-inc">Anebulo Pharmaceuticals</a>, Inc., is a clinical-stage biotechnology company, developing therapeutic compounds for the management of acute cannabinoid intoxication (ACI) and substance addiction. The lead asset, ANEB-001 is a small molecule cannabinoid receptor antagonist being investigated as a specific anti-dote for ACI. To date, no specific treatment or drugs are available for ACI, which remains a highly unmet need.&nbsp;</p>



<p>As the legalization of medical and recreational cannabis use becomes more prevalent in the United States and other countries, habitual use, addiction, and overdose are becoming more common. </p>



<p>Inexperienced cannabis users are particularly susceptible to cannabis poisoning, as a standard dosage (often quoted as 1-5mg for edibles) may not be appropriate for everyone. This can lead to users attempting to adjust their dosage on their own, which can sometimes result in emergency room visits due to symptoms such as palpitations, lack of coordination, high blood pressure, and flushing. In some cases, cannabis poisoning can even result in death. With an increasing number of cannabis poisoning-related emergency room visits, it is crucial to have a reliable and specific treatment to reverse the symptoms of cannabinoid poisoning.</p>



<figure class="wp-block-image size-full"><img decoding="async" loading="lazy" width="705" height="388" src="https://author.biotickr.com/wp-content/uploads/2023/01/image.png" alt="" class="wp-image-31" srcset="https://author.biotickr.com/wp-content/uploads/2023/01/image.png 705w, https://author.biotickr.com/wp-content/uploads/2023/01/image-300x165.png 300w" sizes="(max-width: 705px) 100vw, 705px" /><figcaption class="wp-element-caption">From ANEB&#8217;s <a href="https://ir.anebulo.com/">latest IR deck.</a></figcaption></figure>



<p>ANEB-001 is a cannabinoid antagonist compound that reverses the effect of cannabinoid intoxication in less than 60 minutes. The non-availability of ACI-specific treatment drugs and the fast-acting mechanism of ANEB-001 make the drug stand out as a forerunner in the cannabinoid toxicity therapy race.</p>



<p>Despite, neutral CB1R antagonists appearing more&nbsp;<a rel="noreferrer noopener" href="https://academic.oup.com/ijnp/article/19/Suppl_1/3/2945959" target="_blank">promising</a>&nbsp;than CB1R competitive/orthosteric antagonists/inverse agonists for the treatment of drug abuse and addiction, the rapid onset of ANEB-001 drug action that lasts up to 4.5 to 6 hours (without psychiatric side effects) makes it a perfect and preferable treatment option for cannabinoid overdose.</p>



<p>THC overdose or synthetic marijuana intoxication treatment requires ER admission and short-term treatment with ANEB-001 will likely achieve the treatment goal with lesser likelihood or absolutely no risk of anxiety/depression-like side effects. Even if this occurs, the side effects are temporary (4-6 hours), as the treatment may not exceed one or two doses, underscoring the drug safety.</p>



<p>The phase 2 study was nearing the study completion date, at the end of December 2022.</p>



<h2><strong>Recent Activity&nbsp;</strong></h2>



<p><strong>January 9, 2023</strong> -Anebulo Pharmaceuticals <a href="https://www.otcdynamics.com/aneb-anebulo-pharmaceuticals-announces-completion-of-dosing-and-preliminary-data-from-part-b-of-its-phase-2-study-of-aneb-001-for-acute-cannabinoid-intoxication-2/?utm_campaign=twitter&amp;utm_medium=twitter&amp;utm_source=twitter">Announces</a> Completion of Dosing and Preliminary Data from Part B of its Phase 2 Study of ANEB-001 for Acute Cannabinoid Intoxication. &#8220;<em>Completing the dosing in this Phase 2 trial represents an important milestone for the company. Preliminary data showed that a single 10 mg dose of ANEB-001 reduced key symptoms of ACI induced with 30 mg of THC</em>&#8221; said Simon Allen, CEO of Anebulo.&nbsp;</p>



<p><strong>November 10, 2022</strong> – Anebulo Pharmaceuticals&nbsp;<a rel="noreferrer noopener" href="https://finance.yahoo.com/news/anebulo-pharmaceuticals-reports-first-quarter-130000742.html" target="_blank">reported</a>&nbsp;the first-quarter fiscal year 2023 financial results and recent updates</p>



<p><strong>November 2, 2022</strong> &#8211; Anebulo Pharmaceuticals&nbsp;<a rel="noreferrer noopener" href="https://finance.yahoo.com/news/anebulo-pharmaceuticals-announces-appointment-nat-200000135.html" target="_blank">announced</a>&nbsp;the appointment of Nat Calloway, Ph.D., to the Board of directors</p>



<p><strong>September 26, 2022</strong> &#8211; Lower doses of Anebulo&#8217;s pipeline ANEB-001&nbsp;<a rel="noreferrer noopener" href="https://finance.yahoo.com/news/lower-doses-anebulos-aneb-001-125654258.html" target="_blank">reduced</a>&nbsp;the negative effects of higher doses of THC, ANEB reported&nbsp;</p>



<p><strong>July 5th, 2022</strong> – Anebulo Pharmaceuticals&nbsp;<a rel="noreferrer noopener" href="https://finance.yahoo.com/news/anebulos-aneb-001-reduces-cannabis-115745219.html" target="_blank">reported</a>&nbsp;ANEB-001 reduced cannabis intoxication in healthy participants</p>



<h2><strong>Addressable market</strong></h2>



<p>The global cannabis market is estimated to be around USD 22.5 billion in 2021 and is expected to grow to USD 82.3 by 2027, accounting for both medical and recreational use. While no data are available a 2016 study that reported cannabis poisoning contributed to 0.014% of ED visits. After 6 years and widespread legalization of medical marijuana and recreational use incidence looks to be on the increase.</p>



<p>The Federal Government legalized medical cannabis in 35 states and recreational marijuana use in 15 states. There is no reliable data about street use of spice and/or THC, which increases the overdose risk and accounts for most of the ER visits of spice addicts and occasional recreational marijuana users. If the Federal Government passes the bill to decriminalize marijuana, the upside opportunity of ANEB-001 would naturally multiply.</p>



<p>If gets approved (ANEB-001 would likely be the first approved drug for ACI) the commercial potential is extremely high given there isn&#8217;t any available treatments specific to this indication.</p>



<h2><strong>Current finances:</strong></h2>



<p>As on September 2022, ANEB had USD 19m as cash and no debt. After extrapolating on last year’s cash burn of USD 6.7m, the cash runway could be in the range of 2 to 2.5 years from January 2023. ANEB is prudent with finances but would need to find capital to kickstart a bigger Phase III study.</p>



<h2><strong>Insider activity</strong></h2>



<figure class="wp-block-table"><table><thead><tr><td><strong>INSIDER TRADE</strong><strong></strong></td><td><strong>3 MONTHS</strong><strong></strong></td><td><strong>12 MONTHS</strong><strong></strong></td></tr></thead><tbody><tr><td>Number of Shares Bought</td><td>0</td><td>1,703,577</td></tr><tr><td>Number of Shares Sold</td><td>0</td><td>0</td></tr></tbody></table></figure>



<h2><strong>Competitors</strong></h2>



<p><a href="https://biotickr.com/biotech-stocks/united-kingdom/indv-ln-indivior-plc">Indivor</a> is working to treat patients for treatment of cannabis use disorder, substance abuse treatment and mental disorders. The cannabis use disorder asset AEF0117 is in Phase II clinical trial and is expected to be <a href="https://clinicaltrials.gov/ct2/show/NCT05322941">completed</a> by November 2023.</p>



<p><a href="https://biotickr.com/biotech-stocks/united-states-of-america/opnt-opiant-pharmaceuticals-inc">Opiant</a>’s OPNT004 Drinabant (CB-1 antagonist) is being developed jointly by Opiant pharmaceuticals and Sanofi. The pipeline is early stages of <a href="https://www.opiant.com/products-pipeline/pipeline/opnt004-drinabant-cb-1-antagonist/">development</a> and yet to initiate the human Phase-I clinical trial studies.</p>



<h2><strong>Summary</strong></h2>



<figure class="wp-block-embed is-type-video is-provider-youtube wp-block-embed-youtube wp-embed-aspect-16-9 wp-has-aspect-ratio"><div class="wp-block-embed__wrapper">
<iframe loading="lazy" title="ANEB Biotickr Summary" width="500" height="281" src="https://www.youtube.com/embed/T-KSnyLZLmw?feature=oembed" frameborder="0" allow="accelerometer; autoplay; clipboard-write; encrypted-media; gyroscope; picture-in-picture; web-share" allowfullscreen></iframe>
</div></figure>



<p>ANEB-001 looks like an effective treatment for short-term cannabinoid poisoning and has significant commercial potential for growth. With dosing for the Phase 2 trial complete, the next major step for the compound will be the initiation of a phase 3 clinical trial, which is planned to start in the second quarter of 2023. Among the CB1R-antagonists, ANEB-001 should be considered a frontrunner asset in a space with high unmet need. Holding ANEB at these levels is risky &#8211; with just $19M i the bank a dilutive event is expected despite the leadership being prudent with their capital. Though there is a plausible scenario in which a dilutive event does not happen; M&amp;A. High risk. High reward. Like always when investing in these <a href="https://biotickr.com/biotech-stock-finder/small-cap">small cap biotech stocks</a>.</p>


Quicktake – Anebulo Pharmaceuticals (ANEB)


<p><a href="https://biotickr.com/biotech-stocks/united-states-of-america/krbp-kiromic-biopharma-inc" data-type="URL" data-id="https://biotickr.com/biotech-stocks/united-states-of-america/krbp-kiromic-biopharma-inc">Kiromic BioPharma</a>, Inc. is a clinical-stage, fully integrated biotherapeutics company using its proprietary DIAMOND<sup>®</sup> artificial intelligence (AI) platform to discover and develop cell therapies with a therapeutic focus on immuno-oncology. Kiromic Biopharma is the only cell therapy company combining genetically edited Gamma Delta CAR-T (GD CAR-T) cells with proprietary targeting technology to address solid malignancies.</p>



<p>Kiromic is in the process of developing ALEXIS, a multi-indication allogeneic CAR-T cell therapy platform that exploits the natural potency of gamma delta T-cells to target solid cancers. Kiromic is focused on discovering, developing, and commercializing novel immuno-oncology applications through its robust product pipeline.</p>



<figure class="wp-block-image size-large"><img decoding="async" loading="lazy" width="1024" height="449" src="https://author.biotickr.com/wp-content/uploads/2022/12/testKRBP-1024x449.png" alt="" class="wp-image-14" srcset="https://author.biotickr.com/wp-content/uploads/2022/12/testKRBP-1024x449.png 1024w, https://author.biotickr.com/wp-content/uploads/2022/12/testKRBP-300x132.png 300w, https://author.biotickr.com/wp-content/uploads/2022/12/testKRBP-768x337.png 768w, https://author.biotickr.com/wp-content/uploads/2022/12/testKRBP-1536x674.png 1536w, https://author.biotickr.com/wp-content/uploads/2022/12/testKRBP.png 1780w" sizes="(max-width: 1024px) 100vw, 1024px" /></figure>



<p>The pipeline development is leveraged through the Company’s proprietary target discovery engine called DIAMOND AI<sup>TM</sup>. Kiromic&#8217;s DIAMOND AI<sup>TM</sup> is where data science meets target identification to dramatically compress the years and millions of dollars required to develop a cellular therapeutic.</p>



<h2><strong>Recent Events</strong></h2>



<ul>
<li><strong>May 11, 2022</strong> &#8211; Company Provides Regulatory Update on Progress to Address Previously Outlined Chemistry, Manufacturing, and Control (CMC) Issues Related to Clinical Hold on Investigational New Drug Applications (INDs)</li>



<li><strong>June 7, 2022</strong><em> – </em><a href="https://ir.kiromic.com/news-releases/news-release-details/kiromic-biopharma-significantly-expands-gamma-delta-t-cell">Kiromic Biopharma entered into a sponsored research agreement (SRA) with Principal Investigator James W. Welsh, M.D. of The University of Texas MD Anderson Cancer Center.&nbsp;&nbsp; Under the two-year SRA, in vivo preclinical data will be generated from Kiromic’s Gamma Delta T cell (GDT) allogeneic therapies. This SRA is intended to evaluate efficacy and patient safety outcomes to support three new investigational drug (IND) applications to the U.S. Food and Drug Administration (FDA).</a></li>



<li><strong>July 13, 2022</strong> <a href="https://docoh.com/filing/1792581/0001104659-22-079590/KRBP-S1A">Kiromic files S-1/A with SEC to amend IPO registration for a public offering</a></li>



<li><strong>August 19, 2022</strong><em> &#8211; </em><a href="https://docoh.com/filing/1792581/0001104659-22-092952/KRBP-RW">The Company has determined not to pursue, at this time, the contemplated public offering to which the Registration Statement relates. The Company confirms that no securities have been sold pursuant to the Registration Statement.</a></li>
</ul>



<h2><strong>Addressable Market</strong></h2>



<ul>
<li>Global CAR-T Cell Therapy Market by 2027 to exceed 33+ billion<a href="#_edn1" id="_ednref1">[i]</a></li>



<li>90% of call cancers are solid malignancies<a href="#_edn2" id="_ednref2">[ii]</a></li>
</ul>



<h2><strong>Current Finances</strong></h2>



<ul>
<li><strong>Cash Position</strong><em> $</em>6,510,600 as of Q2 2022 10-Q filing</li>
</ul>



<p>This is a huge red flag given the cash burn noted in previous 10-Q and 10-K filings.&nbsp; The company currently has 300,000,000 shares authorized as of June 30, 2022, and December 31, 2021; 15,839,112 and 15,488,516 shares issued and outstanding as of June 30, 2022, and December 31, 2021, respectively<a>. </a>The Company had negative cash flow from operations of $13,548,000 for the six months ended June 30, 2022, and an accumulated deficit of $83,019,400 as of June 30, 2022. To date, the Company has relied on equity and debt financing to fund its operations. The Company’s product candidates are still in the early stages of development, and substantial additional financing will be needed by the Company to fund its operations and ongoing research and development efforts prior to the commercialization, if any, of its product candidates. The Company does not have sufficient cash on hand or available liquidity to meet its obligations through the twelve months following the date the condensed consolidated financial statements are issued.<a href="#_edn3" id="_ednref3">[iii]</a></p>



<h2><strong>Insider Activity</strong></h2>



<p>No voluntary insider purchases were found within the last 12-month period ending 19 September 2022<a>. </a>All insider acquisitions were grant based compensation.<a href="#_edn4" id="_ednref4">[iv]</a></p>



<p>This is another red flag as any biotech company with near-term positive catalysts known internally may reflect this via insider purchases.</p>



<h2><strong>Legal Issues</strong></h2>



<p>A class action lawsuit has been filed on behalf of those who purchased or acquired Kiromic BioPharma, Inc. (&#8220;Kiromic&#8221;) (NASDAQ: KRBP) common stock between June 25, 2021, and August 5, 2022, inclusive (the &#8220;Class Period&#8221;).&nbsp; This is related to investors being misled by information pertaining to the FDA hold on multiple INDs not being communicated prior to the IPO date.&nbsp; Following the IPO date Kiromic cryptically released this information to investors.&nbsp; A sharp decline in share value quickly followed.&nbsp; A short video regarding this class-action suit can be found <a href="https://www.youtube.com/watch?v=Fhi5rFsBR7U">here</a>.</p>



<p>Legal actions are common in the biotech industry for a plethora of reasons<a>. </a>Many end up in settlements with minor impact to a company’s continued operation<a>. </a>It is, however, another red flag as this specific suit indicates failure of the company’s fiduciary responsibility to shareholders which is critical.</p>



<h2><strong>Summary</strong></h2>



<p>Given the <a>preliminary stages</a> of pipeline development, holds placed by the FDA, and current cash position Kironic Biopharma is ripe for further dilution to fund operations<a>. T</a>he timeline set by the company puts early pre-clinical data from leading INDs is at least a year away following submission to the FDA in late 2022<a>. Given the current macroeconomics at play and immediate dilution risk, investment at this time can pose a significant risk. </a>The company’s unique approach to utilize AI in the CAR-T space could pay out down the road when looking at current <a href="https://docoh.com/filing/1792581/0001104659-22-079956/KRBP-FWP">efficacy and safety data for Procel and Isocel</a>. (Pages 18-19 in prospectus)</p>



<hr class="wp-block-separator has-alpha-channel-opacity"/>



<p><a href="#_ednref1" id="_edn1">[i]</a> https://www.researchandmarkets.com/reports/5410182/global-car-t-cell-therapy-market-by-product</p>



<p><a href="#_ednref2" id="_edn2">[ii]</a> American Cancer Society, Cancer Facts &amp; Figures, 2022.. https://www.cancer.org/research/cancer-facts-statistics.html</p>



<p><a href="#_ednref3" id="_edn3">[iii]</a> https://docoh.com/filing/1792581/0001558370-22-013504/KRBP-10Q-2022Q2</p>



<p><a href="#_ednref4" id="_edn4">[iv]</a> https://docoh.com/company/1792581/KRBP/insider-ownership-history</p>


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