
<p><a href="https://biotickr.com/biotech-stocks/united-states-of-america/pdsb-pds-biotechnology-corporation">PDS Biotech</a> is a clinical-stage immunotherapeutic company developing treatments for cancer and infectious diseases. The proprietary T-cell activating platform Versamune is being employed to deliver disease-specific antigens to treat cancers and infectious diseases. The disease-specific T-cells and neutralizing antibodies effectively attack and destroy cancer cells and infectious organisms.</p>



<p>The lead asset is PDS0101 (HPV16) intended for the treatment of recurrent metastatic head and neck cancer, cervical cancer, and human papillomavirus-related cancers. Several other pipelines include PDS0102 for breast and prostate cancers, PDS0103 for ovarian, lung, and colorectal cancers, and PDS0104 for melanoma. The vaccine pipelines include PDS0203 for COVID-19 prophylaxis and PDS0202 for the influenza vaccine.</p>



<p>PDS0101 is an experimental HPV-targeted immunotherapy for targeted T-cells against various HPV-associated cancers. PDS0101 is being investigated as a combined therapywith immunotherapies and other anti-cancer drugs. The USFDA has granted fast-track&nbsp;<a href="https://www.cancernetwork.com/view/fda-grants-fast-track-designation-to-pds0101-plus-pembrolizumab-in-advanced-head-and-neck-cancer" target="_blank" rel="noreferrer noopener">designation</a>&nbsp;for PDS0101 with Pembrolizumab for advanced head and neck cancer. According to recent studies, the PDS0101-based triplet regimen&nbsp;<a href="https://www.cancernetwork.com/view/pds0101-based-triplet-regimen-demonstrates-long-lasting-benefit-in-difficult-to-treat-hpv-cancers" target="_blank" rel="noreferrer noopener">demonstrated</a>&nbsp;sustained benefits with&nbsp;<a href="https://www.targetedonc.com/view/pds0101-based-triplet-improves-overall-survival-in-hpv-positive-cancers" target="_blank" rel="noreferrer noopener">improved</a>&nbsp;overall survival rates in difficult-in-treat HPV+ cancers without causing additional side effects.</p>



<p>PDS0102 is a novel T-cell receptor gamma alternate reading frame protein (TARP)-targeted immunotherapy to effectively treat TARP-positive cancers. PDS0102 can be administered as a monotherapy or a combined therapy with other immunotherapies. In an early study, PDS0102&nbsp;<a href="https://finance.yahoo.com/news/pds-biotech-announces-abstract-demonstrating-120000045.html" target="_blank" rel="noreferrer noopener">elicited</a>&nbsp;a significant immune response with remarkable tumor shrinking with delayed disease progression.</p>



<p>PDS0103 is an experimental mucin-1-specific immunotherapy to treat MUC-1-positive cancers. The immunotherapy can be administered as a monotherapy or as a combined therapy with other immunotherapies. PDS0103 is best suited to employ the Versamune platform to treat MUC1-related cancers.</p>



<h2><strong>Recent Activity</strong></h2>



<p><strong>February 9th, 2023</strong> &#8211; PDS biotech <a href="https://www.pdsbiotech.com/index.php/investors/news-center/press-releases/press-releases1/125-2023-news/787-iotechnnouncesublicationofreclinicalnfectimun20230208">announces</a> preclinical findings “<em>We are encouraged by the data reported in&nbsp;Viruses&nbsp;which suggest that Infectimune™ is a promising platform for the effective delivery of recombinant protein antigens to the immune system and activation of the immune system for the development of next‐generation universal vaccines against respiratory viruses, including influenza and SARS-CoV-2,</em>” stated Dr. Lauren V. Wood, Chief Medical Officer of PDS Biotech</p>



<p><strong>January 13th, 2023</strong> – PDS Biotech&nbsp;<a rel="noreferrer noopener" href="https://finance.yahoo.com/news/pds-biotech-participate-b-riley-130000359.html" target="_blank">participated</a>&nbsp;at the B. Riley Securities 3rd Annual Oncology Conference</p>



<p><strong>January 3rd, 2023</strong> – PDS Biotech, Merck Germany&nbsp;<a rel="noreferrer noopener" href="https://finance.yahoo.com/news/pds-biotech-merck-germany-enter-161350380.html" target="_blank">entered</a>&nbsp;licensing pact for investigational cancer treatment</p>



<p><strong>December 22nd, 2023</strong> – PDS Biotech&nbsp;<a rel="noreferrer noopener" href="https://finance.yahoo.com/news/pds-biotech-reports-median-overall-130000824.html" target="_blank">reported</a>&nbsp;a median Overall Survival (OS) of 21 Months in advanced, refractory cancer patients having few remaining treatment options and with reported historical survival of 3-4 months</p>



<p><strong>November 14th, 2022</strong> – PDS Biotech&nbsp;<a rel="noreferrer noopener" href="https://finance.yahoo.com/news/pds-biotech-reports-third-quarter-123000137.html" target="_blank">reported</a>&nbsp;third-quarter 2022 financial results and provides a business update.</p>



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



<p>The global HPV-related cancer treatment market size was&nbsp;<a href="https://www.grandviewresearch.com/industry-analysis/human-papillomavirus-associated-disorders-market" target="_blank" rel="noreferrer noopener">valued</a>&nbsp;atUSD 710 million in 2020 and is estimated to hit around USD 23.2 billion by 2026 at a CAGR of 4.5%. The market size is expected to be driven by increasing prevalence rate, various HPV strains and associated cancers, and penetration of approved treatment options.&nbsp;</p>



<h2><strong>Current Finance</strong></h2>



<p>As of November 2022, the company had a cash&nbsp;<a href="https://seekingalpha.com/article/4557547-pds-biotechnology-corporation-pdsb-q3-2022-earnings-call-transcript" target="_blank" rel="noreferrer noopener">position</a>&nbsp;of USD 71.61 million. The total asset was USD 74.89 million, an increase of 33.7% from Q2 2022.</p>



<p>With a total debt of USD 375.25K, the company generated less than USD 1 million in revenue. The net profit was down by -6.66% to USD 7.42 million in Q3 2022. The company is currently unprofitable and not forecasted to be profitable over the next three years.&nbsp;</p>



<p>PDSB&#8217;s total assets were USD 74.89 million, a significant increase of 33.72% from Q2 2022. The total liabilities increased by 5.80% to USD 4.84 million.</p>



<p>Over the past three months, the share price was significantly volatile (+/-17%).</p>



<p>As of Q3 2022, the free cash flow was USD-5.89 million and the cash burn rate was USD 2.47 million. The net used cash was 9.92 million with USD 61.73 million as remaining cash. With remaining cash of USD 61.73 million, the forecasted cash runway is 24.6 months of cash.</p>



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



<figure class="wp-block-image size-full"><img decoding="async" loading="lazy" width="717" height="80" src="https://author.biotickr.com/wp-content/uploads/2023/02/image-4.png" alt="" class="wp-image-119" srcset="https://author.biotickr.com/wp-content/uploads/2023/02/image-4.png 717w, https://author.biotickr.com/wp-content/uploads/2023/02/image-4-300x33.png 300w" sizes="(max-width: 717px) 100vw, 717px" /></figure>



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



<p>Some of the main competitors of <a href="https://biotickr.com/biotech-stocks/united-states-of-america/pdsb-pds-biotechnology-corporation">PDSB</a> are Biotech Acquisition (BIOT), <a href="https://biotickr.com/biotech-stocks/united-states-of-america/atnm-actinium-pharmaceuticals-inc">Actinium Pharmaceuticals (ATNM)</a>, and <a href="https://biotickr.com/biotech-stocks/united-states-of-america/rani-rani-therapeutics-holdings-inc">Rani Therapeutics (RANI)</a>.</p>



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



<p>The potential clinical success of PDS0101 as a treatment option for various HPV-related cancers could be a game-changer in the field. Receiving marketing approval for at least two of these cancers would meet a long-standing need. The versatility of Versamune as a drug delivery platform has the potential to enhance the effectiveness of treatments for both oncological and infectious diseases.</p>



<p>There are no imminent catalyst events for short-term investment, as <a href="https://biotickr.com/biotech-stocks/united-states-of-america/pdsb-pds-biotechnology-corporation">PDSB</a> is currently valued at around $250 million, making it a <a href="https://biotickr.com/biotech-stock-finder/micro-cap">micro</a>&#8211; or <a href="https://biotickr.com/biotech-stock-finder/small-cap">small-cap biotech</a> company. Any partnership, announcement, or data release would have a significant impact on the share price. This stock carries both high risk and high reward, and retail investors are optimistic about its potential as shown below;</p>


<div class="wp-block-image">
<figure class="aligncenter size-full"><img decoding="async" loading="lazy" width="594" height="314" src="https://author.biotickr.com/wp-content/uploads/2023/02/image-11.png" alt="" class="wp-image-136" srcset="https://author.biotickr.com/wp-content/uploads/2023/02/image-11.png 594w, https://author.biotickr.com/wp-content/uploads/2023/02/image-11-300x159.png 300w" sizes="(max-width: 594px) 100vw, 594px" /></figure></div>

<div class="wp-block-image">
<figure class="aligncenter size-full"><img decoding="async" loading="lazy" width="595" height="156" src="https://author.biotickr.com/wp-content/uploads/2023/02/image-12.png" alt="" class="wp-image-137" srcset="https://author.biotickr.com/wp-content/uploads/2023/02/image-12.png 595w, https://author.biotickr.com/wp-content/uploads/2023/02/image-12-300x79.png 300w" sizes="(max-width: 595px) 100vw, 595px" /></figure></div>

Quicktake – PDS Biotech (PDSB)


<p><a href="https://biotickr.com/biotech-stocks/united-states-of-america/imgn-immunogen-inc">ImmunoGen </a>Inc. is a clinical-stage biotechnology company focusing on the development of antibody-drug conjugate (ADC) as a treatment for cancer. The lead pipeline is mirvetuximab soravtansine, an inhibitor of folate-receptor alpha (FRa). The pipeline is in Phase III clinical trial to investigate the safety and efficacy against platinum-resistant ovarian cancer.</p>



<p>The next important pipeline is Pivekimab sunirine, a CD123-specific ADC for the treatment of acute myeloid leukemia and blastic plasmacytoid dendritic cell neoplasm (Phase II). Two other pipelines such as IMGC936 and IMGN151 are in the pre-clinical stages&nbsp;</p>



<p>Platinum-resistant ovarian cancer (PROC) is a type of high-end treatment-resistant ovarian cancer that can unlikely treated by the existing standard-of-care treatment drugs. Limited clinical benefits and significant side effects impede the use of these drugs in PROC.</p>



<p>Mirvetuximab soravtansine (MIRV) is a first-in-class antibody-drug conjugate (ADC) comprising a folate receptor alpha (FRα)-binding antibody, cleavable linker, and the maytansinoid payload DM4, a potent tubulin-targeting agent that has demonstrated significant anti-tumor activity in this difficult-to-treat population. MIRV, an antibody-drug conjugate, delivers the potent tubulin-target agent maytansinoid DM4 directly to the tumor in women with folate receptor (FR)-alpha-positive ovarian cancer.</p>


<div class="wp-block-image">
<figure class="aligncenter size-full"><img decoding="async" loading="lazy" width="483" height="458" src="https://author.biotickr.com/wp-content/uploads/2023/02/image-1.png" alt="" class="wp-image-113" srcset="https://author.biotickr.com/wp-content/uploads/2023/02/image-1.png 483w, https://author.biotickr.com/wp-content/uploads/2023/02/image-1-300x284.png 300w" sizes="(max-width: 483px) 100vw, 483px" /></figure></div>


<p>According to a&nbsp;<a href="https://ascopubs.org/doi/abs/10.1200/JCO.2022.40.16_suppl.5574" target="_blank" rel="noreferrer noopener">pooled</a>&nbsp;analysis of 464 patients (pool of sub-group patients out of other PROC patients), MIRV monotherapy has unique efficacy and low-grade side effects including gastrointestinal and eye problems. According to IMGN, these side effects are manageable, highlighting the favorable risk/benefit in PROC patients.</p>



<p>While similar drugs failed to demonstrate efficacy in platinum-resistant ovarian cancer patients, Mirvetuximab consistently proved the efficacy. The possible reason for these two variable results might be – the competitor drug clinical trials like Farletuzumab&nbsp;<a href="https://clinicaltrials.gov/ct2/show/NCT00738699" target="_blank" rel="noreferrer noopener">failed</a>&nbsp;to include patients with FRα expression; however, IMGN has&nbsp;<a href="https://clinicaltrials.gov/ct2/show/NCT02631876?term=NCT02631876" target="_blank" rel="noreferrer noopener">included</a>&nbsp;the patients expressing FRα in the tumors (proper patient selection).</p>



<p>A durable treatment response with&nbsp;<a href="https://www.healio.com/news/hematology-oncology/20220322/mirvetuximab-soravtansine-shows-durable-efficacy-in-ovarian-cancer-subset" target="_blank" rel="noreferrer noopener">a better</a>&nbsp;safety profile was observed in combined therapy of MIRV and Bevacizumab in high folate receptor alpha recurrent ovarian cancer. The reported reduction in tumor burden was 97% with durable and rapid tumor shrinkage among PROC patients.</p>



<p>FRα is a glycosylphosphatidylinositol (GPI)-anchored membrane protein. Its over-expression in&nbsp;<a href="https://www.oncotarget.com/article/9651/text/" target="_blank" rel="noreferrer noopener">tumors</a>&nbsp;such as ovarian, breast, and lung cancers, low and restricted distribution in normal tissues, alongside emerging insights into tumor-promoting functions and&nbsp;<a href="https://aacrjournals.org/mct/article/16/5/819/92299/Dual-Targeting-of-Epithelial-Ovarian-Cancer-Via" target="_blank" rel="noreferrer noopener">association</a>&nbsp;of expression with patient prognosis, together render FRα an attractive therapeutic target.&nbsp;</p>



<p>Theoretically, great drug but practically, the drug faced failure in the phase III study, and the second phase III clinical is being analyzed and demonstrated the efficacy based on sub-group analysis of patients, a study design that has a long history of failure to gain regulatory approval.</p>



<p>Even an investor with basic knowledge on clinical trials can see the flaws in the clinical trial study&nbsp;<a href="https://clinicaltrials.gov/ct2/show/NCT04296890" target="_blank" rel="noreferrer noopener">design</a>&nbsp;such as</p>



<ol type="1" start="1">
<li>The single group as treatment without a comparator arm or placebo group to demonstrate the efficacy as a comparison</li>



<li>Open-label study or non-masked or blinded study – to reduce treatment bias, it is good to conduct a double-blinded study (neither patient nor investigator is aware whether the patient is taking treatment drug or placebo)</li>



<li>A low number of patient recruitment – just 106 patients in phase III</li>



<li>A high possibility (up to 60%) of repeat studies with a comparator group could be demanded by FDA</li>



<li>In that case, IMGN could try to convince the FDA by showcasing the number of patients in&nbsp;<a href="https://clinicaltrials.gov/ct2/show/NCT01609556?term=NCT01609556" target="_blank" rel="noreferrer noopener">the phase</a>&nbsp;I study (206 patients) and&nbsp;<a href="https://clinicaltrials.gov/ct2/show/NCT02631876?term=NCT02631876" target="_blank" rel="noreferrer noopener">the completed</a>&nbsp;phase III study (366 patients)</li>



<li>Risk of developing eye toxicity – blurred vision, keratopathy, etc, which are said to be reversible (it could be possibly worse and force the patients to discontinue the treatment)</li>
</ol>



<h2><strong>Recent Activity</strong></h2>



<p><strong>January 5th, 2023</strong> – ImmunoGen&nbsp;<a rel="noreferrer noopener" href="https://finance.yahoo.com/news/immunogen-announces-inducement-grants-under-213000560.html" target="_blank">announced</a>&nbsp;inducement grants under Nasdaq listing Rule 5635(c)(4)</p>



<p><strong>January 4th, 2023</strong> – ImmunoGen&nbsp;<a rel="noreferrer noopener" href="https://finance.yahoo.com/news/immunogen-appoints-michael-vasconcelles-md-113000284.html" target="_blank">appointed</a>&nbsp;Michael Vasconcelles, MD, as Executive Vice President, Research, Development, and Medical Affairs</p>



<p><strong>December 26th, 2022</strong> &#8211; ImmunoGen&nbsp;<a rel="noreferrer noopener" href="https://finance.yahoo.com/news/immunogen-announces-webcast-presentation-q-213000333.html" target="_blank">announced</a>&nbsp;a Webcast of Presentation and Q&amp;A at the 41st Annual J.P. Morgan Healthcare Conference</p>



<p><strong>December 10th, 2022</strong> &#8211; ImmunoGen&nbsp;<a rel="noreferrer noopener" href="https://finance.yahoo.com/news/immunogen-presents-findings-expansion-cohorts-153000370.html" target="_blank">presented</a>&nbsp;findings from expansion cohorts in Phase 1b/2 study of Pivekimab Sunirine with Vidaza® and Venclexta® in acute myeloid leukemia at ASH</p>



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



<p>The highest unmet medical need in the cancer niche is platinum-resistant recurrent ovarian cancer. In fact, since the FDA approval of bevacizumab in 2014, no new agents hit the market. While the need to continue to push in both platinum-sensitive and platinum-recurrent diseases, the platinum-resistant disease have the highest unmet need.</p>



<p>The global market size of ovarian cancer was&nbsp;<a href="https://www.businesswire.com/news/home/20191105005512/" target="_blank" rel="noreferrer noopener">valued</a>&nbsp;at USD1.8 billion in 2018 which will continue to increase by USD6.7 billion by 2028 at a CAGR of 14.4%</p>



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



<p>As of September 30th, 2022 <a href="https://biotickr.com/biotech-stocks/united-states-of-america/imgn-immunogen-inc">IMGN</a> had USD309.5 million in cash and cash equivalents. During the same period, the company generated USD15.4 million in revenue including USD8 million from non-cash royalty revenue and the rest from licensing and other milestone fees. The operating expenses were USD92.8 million.</p>



<p>Even though IMGN is currently unprofitable and not forecasted to be profitable over the next 3 years, the stock has returned 7.1% over the past year. IMGN is not significantly volatile over the past three months and remains stable. The company’s revenue is growing faster than the other stocks at the rate of 40.4% per year.</p>



<p>The total cash and short-term investment are USD 309.5 million. The long-term and other assets are equivalent to USD 29.8 million.</p>



<p>The short-term liabilities of USD103.6 million were exceeded by the short-term assets of USD330.4 million.</p>



<p>The long-term liabilities of USD77.2 million were exceeded by the long-term assets of USD330.4 million.</p>



<p>IMGN is debt-free and has an adequate cash runway for more than a year based on the free cash flow.</p>



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



<figure class="wp-block-image size-full"><img decoding="async" loading="lazy" width="715" height="79" src="https://author.biotickr.com/wp-content/uploads/2023/02/image-2.png" alt="" class="wp-image-115" srcset="https://author.biotickr.com/wp-content/uploads/2023/02/image-2.png 715w, https://author.biotickr.com/wp-content/uploads/2023/02/image-2-300x33.png 300w" sizes="(max-width: 715px) 100vw, 715px" /></figure>



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



<p><strong>Genentech</strong>: Avastin® (bevacizumab)&nbsp;</p>



<p>Bevacizumab (approved in 2014) and it is the only drug available in the market, enjoying a monopoly in PROC market.</p>



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



<p>While the science of MIRV appears to be good, the drug failed to demonstrate reasonable efficacy in the late-phase clinical trials. The subgroup analysis could be the last resort, but retail twitter has mixed feelings about the outcome;</p>



<figure class="wp-block-image size-full"><img decoding="async" loading="lazy" width="585" height="274" src="https://author.biotickr.com/wp-content/uploads/2023/02/image.png" alt="" class="wp-image-111" srcset="https://author.biotickr.com/wp-content/uploads/2023/02/image.png 585w, https://author.biotickr.com/wp-content/uploads/2023/02/image-300x141.png 300w" sizes="(max-width: 585px) 100vw, 585px" /></figure>



<p></p>


Quicktake – ImmunoGen Inc., (IMGN)


<p><a href="https://biotickr.com/biotech-stocks/israel/ppbt-it-purple-biotech-ltd">Purple Biotech Ltd.</a>, a clinical-stage company, is developing treatments for cancers to overcome drug resistance. The lead oncology asset CM24 is a monoclonal antibody that is intended to block the cancer-associated antigen (carcinoembryonic antigen). CM24 is being investigated as a combined therapy with anti-PD-1 checkpoint inhibitors. The pipeline is in Phase Ib/II clinical trials for the treatment of pancreatic cancer and non-small cell lung cancer. The next important asset &#8211; NT219 is an insulin receptor substrate 1 and 2 being developed as a treatment for recurrent and/or metastatic solid tumors and squamous cell carcinoma of the head and neck cancer.</p>



<figure class="wp-block-image size-full"><img decoding="async" loading="lazy" width="938" height="458" src="https://author.biotickr.com/wp-content/uploads/2023/01/image-10.png" alt="" class="wp-image-67" srcset="https://author.biotickr.com/wp-content/uploads/2023/01/image-10.png 938w, https://author.biotickr.com/wp-content/uploads/2023/01/image-10-300x146.png 300w, https://author.biotickr.com/wp-content/uploads/2023/01/image-10-768x375.png 768w" sizes="(max-width: 938px) 100vw, 938px" /></figure>



<p>The mechanism of action of CM24 involves immunostimulation, eliciting antibody-dependent cell-mediated cytotoxicity and inhibition of CD66 antigen, which are collectively important to achieve anti-cancer activity. So far, the <a href="https://adisinsight.springer.com/drugs/800042144">reported</a> pharmacokinetics and side effect profile of CM24 appears to be promising. No scientific red flags can be observed.</p>



<p>Similarly, the interim safety studies readout of NT219 appears to be encouraging without serious side effects in advanced cancer patients. Durable efficacy was <a href="https://ascopubs.org/doi/abs/10.1200/JCO.2022.40.16_suppl.3096">observed</a> in gastroesophageal junction cancer and colorectal carcinoma patients. Studies are underway to demonstrate the efficacy in squamous cell carcinoma of the head and neck (SCCHN) and recurrent/metastatic SCCHN patients.</p>



<p>Taken together, so far so good in the clinical trials and the possibilities of clinical trial success appear to be high, if no safety signals are detected.</p>



<h2><strong>Recent events</strong></h2>



<p><strong>January 3<sup>rd</sup>, 2023</strong> Purple Biotech and Mor Research Applications <a href="https://finance.yahoo.com/news/purple-biotech-mor-research-applications-120000046.html">announced</a> research collaboration to identify promising investigational oncology treatments</p>



<p><strong>November 15<sup>th</sup>, 2022</strong> &#8211; <a href="https://finance.yahoo.com/news/purple-biotech-mor-research-applications-120000046.html"></a><a rel="noreferrer noopener" href="https://www.facebook.com/dialog/feed?app_id=458584288257241&amp;link=https%3A%2F%2Ffinance.yahoo.com%2Fnews%2Fpurple-biotech-mor-research-applications-120000046.html%3Fsoc_src%3Dsocial-sh%26soc_trk%3Dfb%26tsrc%3Dfb" target="_blank"></a><a rel="noreferrer noopener" href="https://twitter.com/intent/tweet?text=Purple%20Biotech%20and%20Mor%20Research%20Applications%20Announce%20Research%20Collaboration%20to%20Identify%20Promising%20Investigational%20Oncology%20Treatments&amp;url=https%3A%2F%2Ffinance.yahoo.com%2Fnews%2Fpurple-biotech-mor-research-applications-120000046.html%3Fsoc_src%3Dsocial-sh%26soc_trk%3Dtw%26tsrc%3Dtwtr&amp;via=YahooFinance" target="_blank"></a><a rel="noreferrer noopener" href="mailto:?subject=Purple%20Biotech%20and%20Mor%20Research%20Applications%20Announce%20Research%20Collaboration%20to%20Identify%20Promising%20Investigational%20Oncology%20Treatments&amp;body=https%3A%2F%2Ffinance.yahoo.com%2Fnews%2Fpurple-biotech-mor-research-applications-120000046.html%3Fsoc_src%3Dsocial-sh%26soc_trk%3Dma" target="_blank"></a>Purple Biotech <a href="https://finance.yahoo.com/news/purple-biotech-presents-data-mechanism-120000202.html">presented</a> new data on mechanism of action for CM24 at the AACR Special Conference: cancer metastasis</p>



<p><strong>November 8<sup>th</sup>, 2022</strong> – Purple Biotech <a href="https://finance.yahoo.com/news/purple-biotech-reports-third-quarter-125300303.html">reported</a> third quarter 2022 financial results</p>



<p><strong>November 2<sup>nd</sup>, 2022</strong> – Purple Biotech <a href="https://finance.yahoo.com/news/purple-biotech-appoints-lior-fhima-113700913.html">appointed</a> Lior Fhima as chief financial officer</p>



<p><a href="https://finance.yahoo.com/news/purple-biotech-appoints-lior-fhima-113700913.html"></a><a href="https://www.facebook.com/dialog/feed?app_id=458584288257241&amp;link=https%3A%2F%2Ffinance.yahoo.com%2Fnews%2Fpurple-biotech-appoints-lior-fhima-113700913.html%3Fsoc_src%3Dsocial-sh%26soc_trk%3Dfb%26tsrc%3Dfb" target="_blank" rel="noreferrer noopener"></a><a href="https://twitter.com/intent/tweet?text=Purple%20Biotech%20Appoints%20Lior%20Fhima%20as%20Chief%20Financial%20Officer&amp;url=https%3A%2F%2Ffinance.yahoo.com%2Fnews%2Fpurple-biotech-appoints-lior-fhima-113700913.html%3Fsoc_src%3Dsocial-sh%26soc_trk%3Dtw%26tsrc%3Dtwtr&amp;via=YahooFinance" target="_blank" rel="noreferrer noopener"></a><a href="mailto:?subject=Purple%20Biotech%20Appoints%20Lior%20Fhima%20as%20Chief%20Financial%20Officer&amp;body=https%3A%2F%2Ffinance.yahoo.com%2Fnews%2Fpurple-biotech-appoints-lior-fhima-113700913.html%3Fsoc_src%3Dsocial-sh%26soc_trk%3Dma" target="_blank" rel="noreferrer noopener"></a></p>



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



<p><strong>Solid tumor:</strong></p>



<p>The global solid tumor treatment market is <a href="https://www.precedenceresearch.com/solid-tumor-cancer-treatment-market#:~:text=">valued</a> at USD 185.97 billion in 2022 and expected to reach around USD 532.42 billion by 2032, at a CAGR of 11.09% during 2023 to 2032.</p>



<p><strong>Pancreatic cancer:</strong></p>



<p>The global pancreatic market was <a href="https://www.globenewswire.com/en/news-release/2022/10/27/2542488/0/en/">valued</a> at USD 3.43 billion in 2021 and likely to hit 6.93 billion by 2030 at a CAGR of 8.13% during 2022 – 2030.</p>



<p><strong>Head and neck cancer:</strong></p>



<p>In 2021, the global head and neck cancer treatment <a href="https://www.precedenceresearch.com/head-and-neck-cancer-drugs-market#:~:text=">market</a> was USD 1.51 billion and expected to reach USD 2.99 billion by 2030 at a CAGR of 7.9%.</p>



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



<p><strong>Cash position:</strong></p>



<p>Over the last 5 years, the earnings have declined by around 18% per year and generated less than USD 1 million in revenue. The share price has been highly volatile in the last few months and shareholders could get diluted in the upcoming months.</p>



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



<p>Over the last 6 months, no <a href="https://au.finance.yahoo.com/quote/PPBT/insider-transactions/">shares</a> were transacted (sold or purchased) by the insiders, which is a huge red flag.</p>



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



<p>One of the important <a href="https://www.immunocore.com/our-science">competitors</a> of PPBT is Immunocore, a biotechnology company developing treatments for various cancers, infectious diseases and autoimmune disorders. The lead asset is ImmTAX™ (Immune Mobilizing Monoclonal TCRs against X disease), a bispecific molecule with TCR and effector function against cancer, infections and autoimmunity.</p>



<p>The lead candidate KIMMTRAK that targets gp100 for treatment of uveal melanoma has received USFDA approval and other pipelines such as Tebentafusp is in phase II clinical trial for treatment of advanced melanoma, IMC-F106C and IMC-C103C are intended for treatment of multiple solid tumors. Other candidates are in early stages of clinical trials.&nbsp;</p>



<p><a href="https://biotickr.com/biotech-stocks/united-states-of-america/imvt-immunovant-inc">Immunovant</a> is a clinical-stage biopharmaceutical company <a href="https://www.immunovant.com/pipeline">developing</a> therapies for various autoimmune disorders. The important pipeline Batoclimab (IMVT-1401 is a human monoclonal antibodies to reduce circulatory levels IgG antibody in autoimmune disorders. The next asset IMVT-1402 is a humanized FcRn-targeting antibody,</p>



<p>Some of the medical conditions that can be treated by IMVT-1401 and IMVT-1402 are myasthenia gravis, thyroid eye disorder (TED), chronic inflammatory demyelinated polyneuropathy (CIDP), Graves’ disease, and warm autoimmune hemolytic anemia (WAIHA).</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="Summary of Purple Biotech (PPBT)" width="500" height="281" src="https://www.youtube.com/embed/lPre2ONKy5s?feature=oembed" frameborder="0" allow="accelerometer; autoplay; clipboard-write; encrypted-media; gyroscope; picture-in-picture; web-share" allowfullscreen></iframe>
</div></figure>



<p>Based on the available data, it appears that the science behind PPBT&#8217;s NT219 drug has the potential for success in clinical trials. The company is currently conducting a <a href="https://clinicaltrials.gov/ct2/show/NCT04474470">phase I/II study</a> evaluating NT219 as both a monotherapy and a combination therapy with cetuximab for the treatment of advanced solid tumors and head and neck cancer. The results of this study are expected to be released in Q2 2023, which will be a crucial determining factor in the drug&#8217;s development. </p>



<p>The oncology industry is a highly competitive field, but <a href="https://biotickr.com/biotech-stocks/israel/ppbt-it-purple-biotech-ltd">Purple Biotech</a> appears to have a strong chance of success with its pipeline of drugs in development, despite being in early stages. The company&#8217;s NT219 drug is considered as one of the shots on goal by the company to make an impact in the field of oncology.</p>


Quicktake – Purple Biotech (PPBT)


<p><a href="https://biotickr.com/biotech-stocks/united-states-of-america/bysi-beyondspring-inc">BeyondSpring Inc.</a> is an early-stage clinical trial biopharmaceutical company developing immuno-oncology therapies (anti-cancer drugs). The main pipeline is Plinabulin, an anti-cancer drug that is being investigated as a combined therapy with other biologics such as Nivolumab, a PD-1 antibody for the treatment of NSCLC, Ipilimumab a CTLA-4 antibody for the treatment of small cell lung cancer and other PD-1 and/or PD-L1 inhibitors for the treatment of various cancers. Additionally, three other immuno-oncology pipelines are being developed in pre-clinical stages.</p>



<figure class="wp-block-image size-full"><img decoding="async" loading="lazy" width="950" height="407" src="https://author.biotickr.com/wp-content/uploads/2023/01/image-8.png" alt="" class="wp-image-63" srcset="https://author.biotickr.com/wp-content/uploads/2023/01/image-8.png 950w, https://author.biotickr.com/wp-content/uploads/2023/01/image-8-300x129.png 300w, https://author.biotickr.com/wp-content/uploads/2023/01/image-8-768x329.png 768w" sizes="(max-width: 950px) 100vw, 950px" /></figure>



<p>Last year, BYSI got the&nbsp;<a href="https://beyondspringpharma.com/beyondspring-pharmaceuticals-receives-complete-response-letter-from-the-fda-for-plinabulin-new-drug-application-for-prevention-of-chemotherapy-induced-neutropenia-cin/" target="_blank" rel="noreferrer noopener">complete</a>&nbsp;response letter from the FDA for Plinabulin&#8217;s new drug application (NDA) for the treatment of chemotherapy-induced neutropenia. The company is pushing a late-stage clinical trial to demonstrate the efficacy against CIN and re-submit NDA for the same indication</p>



<p><a href="https://biotickr.com/biotech-stocks/united-states-of-america/bysi-beyondspring-inc">BYSI </a>has published the clinical trial study results that&nbsp;<a rel="noreferrer noopener" href="https://pubmed.ncbi.nlm.nih.gov/32970104/" target="_blank">concluded</a>&nbsp;– the efficacy of Plinabulin is almost similar to pegfilgrastim against neutropenia protection. What we should note is, the study was funded and published by BYSI, which is typically considered as a conflict of interest among the scientific community. No other independent studies are available to verify these scientific claims.</p>



<p>Another important aspect is, the mechanism of action of Plinabulin is almost&nbsp;<a href="https://www.onclive.com/view/unique-mechanism-of-action-positions-plinabulin-as-a-preventive-and-active-therapy-in-breast-cancer-nsclc" target="_blank" rel="noreferrer noopener">similar</a>&nbsp;to that of VERU’s Sabizabulin, which failed to gain FDA approval for COVID-19 treatment.&nbsp;<a href="https://jmedicalcasereports.biomedcentral.com/articles/10.1186/s13256-018-1737-5" target="_blank" rel="noreferrer noopener">Most</a>&nbsp;<a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7213772/" target="_blank" rel="noreferrer noopener">skeptics</a>&nbsp;and&nbsp;<a href="https://www.sciencedirect.com/science/article/pii/S2666084920302291" target="_blank" rel="noreferrer noopener">scientific</a>&nbsp;experts have cried foul about the&nbsp;<a href="https://emj.bmj.com/content/19/3/265" target="_blank" rel="noreferrer noopener">safety</a>&nbsp;of Colchicine, which exerts the same mechanism of action as Sabizabulin and Plinabulin as well.</p>



<h2><strong>Recent events</strong></h2>



<p><strong>December 13th, 2022</strong> &#8211; BeyondSpring <a rel="noreferrer noopener" href="https://finance.yahoo.com/news/beyondspring-presents-positive-data-plinabulin-130000288.html" target="_blank">presented</a> positive data with Plinabulin for the Prevention of Docetaxel-Induced neutropenia in patients with Non-Small cell lung cancer and breast cancer at three medical conferences</p>



<p><strong>September 13th, 2022</strong> – BeyondSpring <a rel="noreferrer noopener" href="https://finance.yahoo.com/news/beyondsprings-lead-cancer-drug-protects-135754761.html" target="_blank">reported</a> the lead cancer drug protects bone marrow stem cells within 24 hours</p>



<p><strong>May 27th, 2022</strong> – BeyondSpring <a rel="noreferrer noopener" href="https://finance.yahoo.com/news/beyondspring-presents-clinical-data-chemotherapy-110000449.html" target="_blank">presented</a> new clinical data in the chemotherapy-Induced Neutropenia and NSCLC programs at the 2022 ASCO annual meeting</p>



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



<p><strong>Non-small cell lung cancer (NSCLC):</strong></p>



<p>The global NSCLC treatment market is&nbsp;<a href="https://www.researchandmarkets.com/reports/5303629/non-small-cell-lung-cancer-nsclc-therapeutics" target="_blank" rel="noreferrer noopener">valued</a>&nbsp;at USD 22.3 billion in 2020 and is expected to reach USD 40.3 billion by 2027 at a CAGR of 8.9%.</p>



<p><strong>Small cell lung cancer (SCLC):</strong></p>



<p>The global SCLC was estimated to be USD 10 billion and&nbsp;<a href="https://www.databridgemarketresearch.com/reports/global-small-cell-lung-cancer-sclc-therapeutics-market" target="_blank" rel="noreferrer noopener">is forecasted</a>&nbsp;to grow up to USD 21.44 billion by 2029.</p>



<p>The global market for&nbsp;<a href="https://www.futuremarketinsights.com/reports/chemotherapy-induced-myelosuppression-treatment-market" target="_blank" rel="noreferrer noopener">the treatment</a>&nbsp;of chemotherapy-induced myelosuppression was USD 8.06 billion in 2022 and is expected to reach USD 9.78 billion by 2028 at a CAGR of 3.3%.</p>



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



<p>Despite the share price being highly volatile over the past three months, the revenue grew by 650.6% in the last year. A few of the notable upsides are: the short-term assets are valued at USD 75.1 million and exceed its short-term liabilities of USD 15.2 million and long-term liabilities of USD 40.1 million.</p>



<p>However, the company is now unprofitable and unlikely to generate revenue or be profitable over the next three years (forecasted decline in earnings by 33.4% per year). The risk of shareholder dilution is high in the coming years.</p>



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



<p><a href="https://biotickr.com/biotech-stocks/united-states-of-america/syrs-syros-pharmaceuticals-inc">Syros Pharmaceuticals</a> are developing small-molecule medicines to control the expression of genes, with the aim to make a profound difference in patients’ lives. They are advancing a pipeline of investigational medicines for diseases that have largely eluded other genomics-based approaches. The main focus is on cancer.</p>



<p>The&nbsp;<a rel="noreferrer noopener" href="https://clinicaltrials.gov/ct2/show/NCT04797780?term=Tamibarotene&amp;draw=2&amp;rank=1" target="_blank">lead</a>&nbsp;asset Tamibarotene is in a phase III clinical trial for the treatment of myelodysplastic disorder and acute myeloid leukemia.</p>



<p><a href="https://biotickr.com/biotech-stocks/united-states-of-america/hcwb-hcw-biologics-inc">HCW Biologics</a> is a clinical-stage company focusing on transformative immunotherapeutic pipelines for the treatment of inflammation-related aging diseases including cancer.</p>



<p>The lead asset is HCW9218 is being investigated in phase 1 and phase ½ clinical trials as a treatment for solid&nbsp;<a href="https://clinicaltrials.gov/ct2/show/NCT05322408" target="_blank" rel="noreferrer noopener">tumors</a>&nbsp;and advanced&nbsp;<a href="https://clinicaltrials.gov/ct2/show/NCT05304936" target="_blank" rel="noreferrer noopener">pancreatic</a>&nbsp;cancer, respectively. HCW9218 is a bifunctional fusion protein complex formulated with the TGF-β receptor, IL-15, and other immunostimulatory molecules to achieve significant anti-cancer benefits. HCW9218 is said to be effective against the chemotherapy-resistant mechanisms of cancer.</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="Summary of BYSI" width="500" height="281" src="https://www.youtube.com/embed/PK5cn0-Pq_8?feature=oembed" frameborder="0" allow="accelerometer; autoplay; clipboard-write; encrypted-media; gyroscope; picture-in-picture; web-share" allowfullscreen></iframe>
</div></figure>



<p>The underlying science of Plinabulin appears to be unviable for anti-cancer treatment. Even if it demonstrates some efficacy, it might not be superior to the existing drug Pegfilgrastim for the prevention of chemotherapy-induced neutropenia. It makes no sense to develop a drug that is not so effective or superior to an existing drug for the same indication. As per the available open-source data, there is no near-term binary or catalyst event for short-term investment in <a href="https://biotickr.com/biotech-stocks/united-states-of-america/bysi-beyondspring-inc">Beyondspring stock</a>.</p>


Quicktake – BeyondSpring (BYSI)


<p><a href="https://biotickr.com/biotech-stocks/united-states-of-america/cytk-cytokinetics-inc">Cytokinetics (CYTK)</a>, is a late clinical-stage biopharmaceutical company focusing on the development and commercialization of muscle activators and inhibitors as therapeutics for cardiovascular disorders. These small molecules are believed to optimize muscle function and contractility. The main asset, Omecamtiv mecarbil is a cardiac myosin activator that is investigated as a treatment for heart failure and is waiting for the USFDA marketing application approval. The USFDA has raised&nbsp;<a rel="noreferrer noopener" href="https://www.reuters.com/business/healthcare-pharmaceuticals/fda-staff-reviewers-flag-safety-concerns-over-cytokinetics-heart-drug-2022-12-09/" target="_blank">safety</a>&nbsp;concerns and observed limited efficacy, and the Cardiovascular and Renal Drugs Advisory Committee (CRDAC) voted 8-3 against the marketing approval. The panel&nbsp;<a rel="noreferrer noopener" href="https://finance.yahoo.com/news/fda-adcomm-gives-thumbs-down-114054817.html" target="_blank">observed</a>&nbsp;the drug’s potential benefits did not outweigh the risks. The marketing approval application for Omecamtiv mecarbil is under regulatory agency review with a Prescription Drug User Fee Act (PDUFA) target action date of February 28, 2023.</p>



<figure class="wp-block-image size-full"><img decoding="async" loading="lazy" width="840" height="408" src="https://author.biotickr.com/wp-content/uploads/2023/01/image-7.png" alt="" class="wp-image-61" srcset="https://author.biotickr.com/wp-content/uploads/2023/01/image-7.png 840w, https://author.biotickr.com/wp-content/uploads/2023/01/image-7-300x146.png 300w, https://author.biotickr.com/wp-content/uploads/2023/01/image-7-768x373.png 768w" sizes="(max-width: 840px) 100vw, 840px" /></figure>



<p>The next important pipeline Reldesemtiv is being&nbsp;<a href="https://clinicaltrials.gov/ct2/show/NCT04944784" target="_blank" rel="noreferrer noopener">investigated</a>&nbsp;in Phase III clinical trial as a treatment for amyotrophic lateral sclerosis (ALS). It is noteworthy to mention – the drug terribly&nbsp;<a href="https://www.als.net/news/cytokinetics-reldesemtiv-improves-decline-in-als-but-fails-to-meet-clinical-endpoints/" target="_blank" rel="noreferrer noopener">failed</a>&nbsp;to meet all the endpoints in Phase II clinical trial (no better than the sham treatment group), and still pushed forward to the Phase III study.&nbsp;</p>



<p>Another important pipeline Aficamten, a novel cardiac myosin inhibitor is in Phase III study as a treatment for symptomatic obstructive hypertrophic cardiomyopathy. The safety and efficacy of Aficamten, particularly in long-term studies is yet to be demonstrated beyond doubt.&nbsp;</p>



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



<p><strong>December 14th, 2022</strong> – FDA Adcomm gave&nbsp;<a rel="noreferrer noopener" href="https://finance.yahoo.com/news/fda-adcomm-gives-thumbs-down-114054817.html" target="_blank">thumbs</a>&nbsp;down to Cytokinetics&#8217; heart failure candidate</p>



<p><strong>December 9th, 2022</strong> &#8211; Cytokinetics&nbsp;<a rel="noreferrer noopener" href="https://finance.yahoo.com/news/cytokinetics-announces-availability-briefing-documents-135900536.html" target="_blank">announced</a>&nbsp;the availability of briefing documents for the FDA Advisory Committee Meeting on Omecamtiv Mecarbil</p>



<p><strong>December 7th, 2022</strong> &#8211; Cytokinetics announced&nbsp;<a rel="noreferrer noopener" href="https://finance.yahoo.com/news/cytokinetics-announces-initiation-phase-1-123000435.html" target="_blank">the initiation</a>&nbsp;of Phase 1 clinical study of CK-3828136</p>



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



<p>The HCM market size was&nbsp;<a href="As%20a%20fall%20out%20of%20the%20USFDA%20panel%20negative%20voting,%20the%20regulatory%20agency’s%20decision%20on%20marketing%20application%20approval%20is%20highly%20unlikely.%20CYTK%20investors%20are%20now%20eyeing%20on%20the%20next%20important%20pipeline,%20Aficamten,%20a%20drug%20being%20investigated%20for%20the%20treatment%20of" target="_blank" rel="noreferrer noopener">around</a>&nbsp;USD 301.3 million in 2020 and is estimated to reach USD 1.9 billion by 2029.&nbsp;&nbsp;</p>



<p>The&nbsp;<a href="https://www.ahajournals.org/doi/10.1161/circresaha.117.311059" target="_blank" rel="noreferrer noopener">prevalence</a>&nbsp;of HCM among the adult population is estimated to be 0.16% to 0.29% ((≈ 1:625–1:344)</p>



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



<p><a href="https://biotickr.com/biotech-stocks/united-states-of-america/cytk-cytokinetics-inc">Cytokinetics</a> has a considerable amount of cash on hand, with an estimated $896 million available to fund operations for the next two years. The company&#8217;s projected R&amp;D spending for 2023 is approximately $148 million, with a significant portion of that budget allocated towards the development of Aficamten. Specifically, it is estimated that spending for Aficamten accounts for approximately 60% of the total R&amp;D budget for the year. This highlights the importance of Aficamten in the company&#8217;s pipeline, and the significant resources being dedicated towards its advancement. It is worth noting that having a sufficient cash reserve is crucial for a biopharmaceutical company like Cytokinetics as it allows them to continue to invest in research and development, as well as maintain operations. With this in mind, the company&#8217;s strong financial position is a positive sign for the future.</p>



<h2><strong>Insider activity&nbsp;</strong></h2>



<figure class="wp-block-image size-full"><img decoding="async" loading="lazy" width="715" height="75" src="https://author.biotickr.com/wp-content/uploads/2023/01/image-2.png" alt="" class="wp-image-49" srcset="https://author.biotickr.com/wp-content/uploads/2023/01/image-2.png 715w, https://author.biotickr.com/wp-content/uploads/2023/01/image-2-300x31.png 300w" sizes="(max-width: 715px) 100vw, 715px" /></figure>



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



<p><a href="https://biotickr.com/biotech-stocks/united-states-of-america/0r1f-ln-bristol-myers-squibb-co">Bristol-Myers Squibb</a> is developing Mavacamten (MYK-461) for the management of symptomatic obstructive hypertrophic cardiomyopathy and the&nbsp;<a rel="noreferrer noopener" href="https://clinicaltrials.gov/ct2/show/NCT03496168?cond=hypertrophic+cardiomyopathy&amp;draw=2&amp;rank=34" target="_blank">study</a>&nbsp;is in a phase II clinical trial.</p>



<p><a href="https://biotickr.com/biotech-stocks/south-korea/068760-kq-celltrion-pharm-inc">Celltrion</a> is&nbsp;<a rel="noreferrer noopener" href="https://clinicaltrials.gov/ct2/show/NCT04418297?cond=hypertrophic+cardiomyopathy&amp;draw=3&amp;rank=130" target="_blank">conducting</a>&nbsp;a phase I clinical trial to assess the pharmacokinetics and pharmacodynamics of CT-G20 as a treatment for obstructive hypertrophic cardiomyopathy.</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="CYTK Biotickr Summary" width="500" height="281" src="https://www.youtube.com/embed/wVGYQ6Wqa5A?feature=oembed" frameborder="0" allow="accelerometer; autoplay; clipboard-write; encrypted-media; gyroscope; picture-in-picture; web-share" allowfullscreen></iframe>
</div></figure>



<p>As a result of the negative vote by the US FDA panel, it is highly unlikely that the regulatory agency will approve the marketing application for Omecamtiv mecarbil. Should this be the case, <a href="https://biotickr.com/biotech-stocks/united-states-of-america/cytk-cytokinetics-inc">CYTK</a> can redirect its capital towards other segments of its pipeline. Additionally, there is always the possibility of addressing/revisiting the FDA&#8217;s findings in the future. The main short term concern is the potential impact on the company&#8217;s share price, and hence its ability to raise further cash at a decent valuation. However, for investors who are willing to take a long-term view, there may be value to be found in this company.</p>



<p>In the long term, there&#8217;s Aficamten (an investigational, novel, oral, small molecule cardiac myosin inhibitor), a different asset in <a href="https://biotickr.com/biotech-stocks/united-states-of-america/cytk-cytokinetics-inc">CYTK</a>&#8216;s pipeline, might turn into its lead compound. However, it is important to note that the science, efficacy and safety of Aficamten have yet to be proven. Investing in <a href="https://biotickr.com/biotech-stocks/united-states-of-america/cytk-cytokinetics-inc">CYTK</a> carries a significant level of risk at these levels &#8211; with the PDUFA date just weeks away.</p>


Quicktake – Cytokinetics (CYTK)


<p>Formerly known as Impel Neuropharma Inc, <a href="https://biotickr.com/biotech-stocks/united-states-of-america/impl-impel-pharmaceuticals-inc">Impel Pharmaceuticals</a> Inc is a commercial-stage biopharmaceutical company, developing and commercializing treatments for central nervous system disorders in the United States. The approved asset is Trudhesa, an upper nasal formulation of dihydroergotamine for the treatment of migraine. <a href="https://biotickr.com/biotech-stocks/united-states-of-america/impl-impel-pharmaceuticals-inc">IMPL</a> is now developing INP105 (upper nasal formulation of Olanzepine) as a treatment for acute agitation and aggression in autism spectrum disorder. INP107 is an upper nasal formulation of carbidopa/levodopa being developed in late phase clinical trial (completed Phase 2a) as a treatment for off episodes in Parkinson’s disease. All the assets are wholly owned by IMPL and the upper nasal drug delivery route is an easy and potentially effective route of administration for these CNS indications. The drug absorption via the upper nasal route is high and thus has a high likelihood of good efficacy outcomes.&nbsp;</p>



<figure class="wp-block-image size-full"><img decoding="async" loading="lazy" width="791" height="357" src="https://author.biotickr.com/wp-content/uploads/2023/01/image-12.png" alt="" class="wp-image-71" srcset="https://author.biotickr.com/wp-content/uploads/2023/01/image-12.png 791w, https://author.biotickr.com/wp-content/uploads/2023/01/image-12-300x135.png 300w, https://author.biotickr.com/wp-content/uploads/2023/01/image-12-768x347.png 768w" sizes="(max-width: 791px) 100vw, 791px" /></figure>



<p>Trudhesa is a reliable treatment option for migraine and its real-time clinical applicability has been reported to be promising.&nbsp;</p>



<p>These drugs can be self-administered by POD devices and on-demand access to treatment can be ensured without the need for injections and hospitalization.&nbsp;</p>



<h2><strong>Recent events</strong></h2>



<p><strong>November 14th, 2022</strong> &#8211; Impel Pharmaceuticals&nbsp;<a rel="noreferrer noopener" href="https://finance.yahoo.com/news/impel-pharmaceuticals-announces-third-quarter-130000355.html" target="_blank">announced</a>&nbsp;third quarter 2022 financial results and provides a corporate update</p>



<p><strong>November 14th, 2022</strong> – Impel Pharmaceuticals&nbsp;<a rel="noreferrer noopener" href="https://finance.yahoo.com/news/impel-pharmaceuticals-report-third-quarter-210100493.html" target="_blank">reported</a>&nbsp;third-quarter 2022 financial results</p>



<p><strong>August 15th, 2022</strong> &#8211; Impel Pharmaceuticals&nbsp;<a rel="noreferrer noopener" href="https://finance.yahoo.com/news/impel-pharmaceuticals-report-second-quarter-120000605.html" target="_blank">reported</a>&nbsp;second quarter 2022 financial results.&nbsp;</p>



<h2><strong>Addressable markets</strong></h2>



<p>The global acute migraine treatment market was&nbsp;<a href="https://www.globenewswire.com/news-release/2022/09/02/2509070/0/en/Acute-Migraine-Drugs-Market-Size-to-Reach-USD-9-26-Billion-by-2030-Says-The-Brainy-Insights.html#:~:text=02%2C 2022" target="_blank" rel="noreferrer noopener">valued</a>&nbsp;at USD 4.3 billion and is expected to hit USD 9.26 million by 2030 at a CAGR of 8.9% in the forecasted period.&nbsp;</p>



<p>The global autism spectrum disorder treatment market was&nbsp;<a href="https://www.futuremarketinsights.com/reports/autism-spectrum-disorder-management-market" target="_blank" rel="noreferrer noopener">valued</a>&nbsp;at USD 2063 million in 2022 and is expected to reach USD 3630 billion by 2032 at a CAGR of 5.3%</p>



<p>By 2021, the global Parkinson’s disease treatment market size was&nbsp;<a href="https://www.grandviewresearch.com/industry-analysis/parkinsons-disease-treatment-market#:~:text=The global Parkinson's disease treatment,12.1% from 2022 to 2030." target="_blank" rel="noreferrer noopener">estimated</a>&nbsp;to be USD 4.28 billion and expected to grow at a CAGR of 12.1% until 2030.&nbsp;</p>



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



<p>While the company has USD 79.9 M as cash and short-term investment, it has a whooping USD 107.7 M as debt and liabilities.</p>



<p><a href="https://biotickr.com/biotech-stocks/united-states-of-america/impl-impel-pharmaceuticals-inc">IMPL</a> revenue grew by 8934.1% over the past year and is forecasted to grow by at least 44% every year.</p>



<p>The notable risk of IMPL is the company has a cash runway of less than a year risking the dilution of shareholders. The free cash flow continues to shrink at the rate of 40% per year. The short-term assets are not covering short-term and long-term liabilities, which is mention-worthy. Other than the given revenue generation, the company is not profitable and is not expected to be profitable over the next three years.</p>



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



<figure class="wp-block-image size-full"><img decoding="async" loading="lazy" width="715" height="79" src="https://author.biotickr.com/wp-content/uploads/2023/01/image-5.png" alt="" class="wp-image-57" srcset="https://author.biotickr.com/wp-content/uploads/2023/01/image-5.png 715w, https://author.biotickr.com/wp-content/uploads/2023/01/image-5-300x33.png 300w" sizes="(max-width: 715px) 100vw, 715px" /></figure>



<h2><strong>Competitors&nbsp;</strong></h2>



<p><a href="https://biotickr.com/biotech-stocks/united-states-of-america/atos-atossa-therapeutics-inc">Atossa therapeutics</a> is developing (Z)-endoxifen as a potential treatment for cancer. The product is a selective estrogen receptor modulator (SERM) and an active metabolite of tamoxifen. At higher doses, (Z)-endoxifen is effective against certain breast cancer-causing proteins. The experimental drug is being evaluated as a preventive option in certain individuals at-risk of breast cancer. Z-endoxifen has been approved as a treatment for breast cancer in the United States and the company is running several clinical trials&nbsp;<a rel="noreferrer noopener" href="https://clinicaltrials.gov/ct2/results?cond=&amp;term=atossa&amp;cntry=&amp;state=&amp;city=&amp;dist=" target="_blank">including</a>&nbsp;phase II clinical trials.</p>



<p><a href="https://biotickr.com/biotech-stocks/united-states-of-america/seel-seelos-therapeutics-inc">Seelos Therapeutics</a> is developing treatments for various unmet needs in rare disorders and neurological disorders including CNS disorders. Some of the other indications being focused on are acute suicidal ideation and behavior in major depressive disorder and post-traumatic stress disorder. Some of these indications have no approved therapy and hence it is a multibillion-dollar opportunity. The company owns a variety of pipelines that are being investigated in pre-clinical to phase IIb/III studies.&nbsp;</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="IMPL Biotickr Summary" width="500" height="281" src="https://www.youtube.com/embed/xpabyvrTLNo?feature=oembed" frameborder="0" allow="accelerometer; autoplay; clipboard-write; encrypted-media; gyroscope; picture-in-picture; web-share" allowfullscreen></iframe>
</div></figure>



<p>Despite not receiving much attention from the media or investors, the company has been steadily working towards the successful launch of this innovative new drug. With a strong team in place and a well-designed plan for the launch of the drug, <a href="https://biotickr.com/biotech-stocks/united-states-of-america/impl-impel-pharmaceuticals-inc">Impel Pharmaceuticals</a> is well-positioned to make a significant impact in the market. While the company may have slipped under the radar in the past, it is definitely one to keep an eye on in the future as it continues to move its pipeline forward and scale up the commercial operation. The bigger question is will the Trudhesa reduce the need for cash?</p>


Quicktake – Impel Pharmaceuticals (IMPL)


<p><a href="https://biotickr.com/biotech-stocks/germany/9vc-gf-atai-life-sciences-nv">ATAI Life Sciences</a> is a clinical-stage biopharmaceutical company focusing on the development of therapeutic solutions for various mental health disorders including treatment-resistant depression (TRD).</p>



<p>ATAI has a plethora of pipelines&nbsp;<a rel="noreferrer noopener" href="https://atai.life/programs/psilocybin/" target="_blank">including</a>&nbsp;COMP360 psilocybin for TRD in Phase 2 clinical trial, PCN-101, a subcutaneous formulation of R-ketamine for TRD, GRX-917, a deuterated version of Etifoxine, DMX-1002 ibogaine and KUR-101, a deuterated mitragynine for opioid use disorder.&nbsp;</p>



<figure class="wp-block-image size-full is-resized"><img decoding="async" loading="lazy" src="https://author.biotickr.com/wp-content/uploads/2023/01/image-6.png" alt="" class="wp-image-59" width="840" height="425" srcset="https://author.biotickr.com/wp-content/uploads/2023/01/image-6.png 560w, https://author.biotickr.com/wp-content/uploads/2023/01/image-6-300x152.png 300w" sizes="(max-width: 840px) 100vw, 840px" /></figure>



<p>Although the R-ketamine pipeline PCN-101 has&nbsp;<a rel="noreferrer noopener" href="https://markets.businessinsider.com/news/stocks/atai-life-sciences-phase-2a-trial-of-pcn-101-fails-to-meet-primary-endpoint-1032004187" target="_blank">failed</a>&nbsp;to show therapeutic benefit in phase II clinical trials, the psilocybin pipeline looks like a potential win in TRD.</p>



<p>Psilocybin is a naturally-occurring psychedelic compound, being investigated for the treatment of treatment-resistant depression (TRD), which is unlikely treated by existing anti-depressant drugs. Psilocybin treats TRD effectively without significant side effects.&nbsp;<a href="https://jamanetwork.com/journals/jamapsychiatry/fullarticle/210962" target="_blank" rel="noreferrer noopener">Accumulating</a>&nbsp;evidence suggests that psilocybin with accompanying psychological support can be used safely to treat a&nbsp;<a href="https://pubmed.ncbi.nlm.nih.gov/27909165/?dopt=Abstract" target="_blank" rel="noreferrer noopener">range</a>&nbsp;of psychiatric conditions,&nbsp;<a href="https://journals.sagepub.com/doi/10.1177/0269881116675512" target="_blank" rel="noreferrer noopener">including</a>&nbsp;end-of-life&nbsp;<a href="https://journals.sagepub.com/doi/10.1177/0269881114565144" target="_blank" rel="noreferrer noopener">anxiety</a>&nbsp;and depression,&nbsp;<a href="https://journals.sagepub.com/doi/10.1177/0269881114548296" target="_blank" rel="noreferrer noopener">alcohol</a>&nbsp;and tobacco addiction,&nbsp;<a href="https://www.psychiatrist.com/jcp/ocd/safety-tolerability-efficacy-psilocybin-patients-obsessive/" target="_blank" rel="noreferrer noopener">obsessive-compulsive</a>&nbsp;disorder, and most&nbsp;<a href="https://linkinghub.elsevier.com/retrieve/pii/S2215036616300657" target="_blank" rel="noreferrer noopener">recently</a>, treatment-resistant major depression.&nbsp;</p>



<p>Clinical&nbsp;<a href="https://pubmed.ncbi.nlm.nih.gov/35166158/" target="_blank" rel="noreferrer noopener">trials</a>&nbsp;have shown – one or two&nbsp;<a href="https://pubmed.ncbi.nlm.nih.gov/33146667/" target="_blank" rel="noreferrer noopener">doses</a>&nbsp;of psilocybin&nbsp;<a href="https://pubmed.ncbi.nlm.nih.gov/27210031/" target="_blank" rel="noreferrer noopener">rapidly</a>&nbsp;relieved depression symptoms and the&nbsp;<a href="https://www.nejm.org/doi/full/10.1056/NEJMe2210975" target="_blank" rel="noreferrer noopener">treatment</a>&nbsp;benefits&nbsp;<a href="https://www.nejm.org/doi/full/10.1056/NEJMoa2206443" target="_blank" rel="noreferrer noopener">lasted</a>&nbsp;over 4 weeks to 12 months. These&nbsp;<a href="https://www.nejm.org/doi/full/10.1056/NEJMoa2206443" target="_blank" rel="noreferrer noopener">results</a>&nbsp;are also from a well-powered rigorous, multi-centric phase II clinical trial involving depressive patients, who received one or three doses of psilocybin.</p>



<p>A single oral dose of 25mg of psilocybin with psychological support for 5-8 during the hallucinogenic side effects (if any) could&nbsp;<a href="https://pubmed.ncbi.nlm.nih.gov/36040772/" target="_blank" rel="noreferrer noopener">significantly</a>&nbsp;decrease the depression severity with acceptable side effects. The anti-depressant benefits are comparable to Escitalopram (a well-established anti-depressant drug)</p>



<p>Another well-controlled clinical&nbsp;<a href="https://journals.sagepub.com/doi/10.1177/02698811211073759" target="_blank" rel="noreferrer noopener">study</a>&nbsp;that involved 27 depression patients who were assigned to receive two doses of psilocybin and followed up for 8 weeks to 12 months showed a significant reduction in depression symptoms (before Vs after treatment) and treatment&nbsp;<a href="https://d-nb.info/1150055693/34" target="_blank" rel="noreferrer noopener">benefits</a>&nbsp;were sustained/durable over 12 months (with just two doses). None of the existing anti-depressant drugs can achieve such a treatment success without any risk of side effects.</p>



<p>Based on these findings, the investors could understand &#8211; sustained treatment response over months could be something like a ‘functional cure’ than remission (staying without symptoms).</p>



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



<p><strong>6th January 2023</strong> &#8211; atai Life Sciences&nbsp;<a rel="noreferrer noopener" href="https://finance.yahoo.com/news/atai-life-sciences-announces-results-120000945.html" target="_blank">announced</a>&nbsp;results from Phase 2a Trial of PCN-101 (R-ketamine) for treatment-resistant depression.</p>



<p><strong>23rd December 2022</strong> &#8211; Atai Life Sciences announced&nbsp;<a rel="noreferrer noopener" href="https://finance.yahoo.com/news/atai-life-sciences-announces-results-115900336.html" target="_blank">results</a>&nbsp;from the Kures Therapeutics Phase 1 Trial of KUR-101</p>



<p><strong>19th December 2022</strong> &#8211; Atai Life Sciences&nbsp;<a rel="noreferrer noopener" href="https://finance.yahoo.com/news/atai-life-sciences-initiates-phase-115900146.html" target="_blank">initiated</a>&nbsp;phase 2b proof-of-concept trial of RL-007 for cognitive impairment associated with schizophrenia</p>



<p><strong>November 29th, 2022</strong> &#8211; Atai Life Sciences&nbsp;<a rel="noreferrer noopener" href="https://finance.yahoo.com/news/atai-life-sciences-strengthens-leadership-115900075.html" target="_blank">strengthens</a>&nbsp;its leadership team with the appointment of Dr. Sahil V. Kirpekar as Chief business officer</p>



<p><strong>November 10th, 2022</strong> – Atai Life Sciences&nbsp;<a rel="noreferrer noopener" href="https://finance.yahoo.com/news/atai-life-sciences-reports-third-115900575.html" target="_blank">reported</a>&nbsp;the third quarter 2022 financial results and business update.</p>



<p><strong>October 13th, 2022</strong> – IntelGenx’s&nbsp;<a rel="noreferrer noopener" href="https://finance.yahoo.com/news/intelgenx-collaboration-atai-life-sciences-132100606.html" target="_blank">collaboration</a>&nbsp;with Atai Life Sciences culminates in the initiation of the first-in-human clinical study of an oral thin film psychedelic drug candidate.&nbsp;</p>



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



<p>Global treatment-resistant depression is the highest unmet need in mental health disorders – depressive disorder particularly treatment-resistant depression.</p>



<p>Valued at $1.52 billion in 2021 and&nbsp;<a href="https://www.fortunebusinessinsights.com/treatment-resistant-depression-treatment-market-102820" target="_blank" rel="noreferrer noopener">expected</a>&nbsp;to grow by $1.55 billion to $2.83 billion by 2029.</p>



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



<p><a href="https://biotickr.com/biotech-stocks/germany/9vc-gf-atai-life-sciences-nv">ATAI</a> is heavily relying on equity and debt financing for operational funds and the pipelines are in the early stages of development, raising financial red flags. ATAI likely requires substantial additional funding for the ongoing research and development until commercialization, if approved.</p>



<p>As of mid-August 2022, the company&nbsp;<a href="https://ir.atai.life/news-releases/news-release-details/atai-life-sciences-reports-second-quarter-2022-financial-results" target="_blank" rel="noreferrer noopener">positioned</a>&nbsp;itself well to secure a non-dilutive loan of up to USD175M, and thus generated USD 312M as cash to run operations. The cash burn trajectory over a year could be USD73M and a cash runway of approximately 3.8 years from now.</p>



<p>With cash deficits and the non-availability of liquidity, the risk of shareholder dilution is high.&nbsp;&nbsp;</p>



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



<figure class="wp-block-image size-full"><img decoding="async" loading="lazy" width="612" height="77" src="https://author.biotickr.com/wp-content/uploads/2023/01/image-1.png" alt="" class="wp-image-47" srcset="https://author.biotickr.com/wp-content/uploads/2023/01/image-1.png 612w, https://author.biotickr.com/wp-content/uploads/2023/01/image-1-300x38.png 300w" sizes="(max-width: 612px) 100vw, 612px" /></figure>



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



<p><a href="https://biotickr.com/biotech-stocks/canada/trypf-tryp-therapeutics-inc">Tryp Therapeutics</a> is conducting Phase II clinical trials to assess the efficacy and safety of psilocybin and psilocybin-based drug products for chronic pain and eating disorders. The lead&nbsp;<a rel="noreferrer noopener" href="https://tryptherapeutics.com/pipeline" target="_blank">asset</a>&nbsp;TRP-0082 is now in Phase 2a clinical trial for the management of binge eating disorder.&nbsp;</p>



<p><a href="https://biotickr.com/biotech-stocks/canada/cybn-cybin-inc">Cybin</a> is&nbsp;<a rel="noreferrer noopener" href="https://cybin.com/development-pipeline/" target="_blank">developing</a>&nbsp;the lead asset CYB003 (Deuterated psilocybin analogue) in phase I/II&nbsp;<a rel="noreferrer noopener" href="https://clinicaltrials.gov/ct2/show/NCT05385783" target="_blank">study</a>&nbsp;for the management of the major depressive disorder. The study is expected to be completed by mid-2023.</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="ATAI Biotickr Summary" width="500" height="281" src="https://www.youtube.com/embed/rCAIguHpVsI?feature=oembed" frameborder="0" allow="accelerometer; autoplay; clipboard-write; encrypted-media; gyroscope; picture-in-picture; web-share" allowfullscreen></iframe>
</div></figure>



<p>The scientific evidence supporting the use of naturally-derived psilocybin as an anti-depressant is well-established through various clinical studies. The chances of COMP360&#8217;s psilocybin product successfully completing clinical trials and receiving regulatory approval are high. A single dose or a small number of doses of psilocybin has been shown to effectively alleviate symptoms of treatment-resistant depression (TRD) and the benefits can last for up to a year, which is not typically seen with current anti-depressant medications. A key upcoming event for <a href="https://biotickr.com/biotech-stocks/germany/9vc-gf-atai-life-sciences-nv">ATAI</a> will be the start of the Phase III psilocybin study, which is expected to begin within six months.</p>


Quicktake – Atai Life Sciences (ATAI)


<p><a href="https://biotickr.com/biotech-stocks/united-states-of-america/aqst-aquestive-therapeutics-inc">Aquestive Therapeutics</a>, Inc is a clinical and commercial-stage pharmaceutical company focusing on the development and commercialization of various therapeutic drugs to meet various unmet needs in the United States and across the globe.&nbsp;</p>



<p>AQST has focused on the development of orally-soluble film as a delivery platform for several drugs to treat various medical conditions. The core strength of the company’s pipeline is reinventing the way of treatment by administering the pre-existing drug via a novel drug delivery proprietary platform called Pharmafilm Technology.&nbsp;</p>



<figure class="wp-block-image size-large"><img decoding="async" loading="lazy" width="1024" height="450" src="https://author.biotickr.com/wp-content/uploads/2023/01/image-9-1024x450.png" alt="" class="wp-image-65" srcset="https://author.biotickr.com/wp-content/uploads/2023/01/image-9-1024x450.png 1024w, https://author.biotickr.com/wp-content/uploads/2023/01/image-9-300x132.png 300w, https://author.biotickr.com/wp-content/uploads/2023/01/image-9-768x337.png 768w, https://author.biotickr.com/wp-content/uploads/2023/01/image-9.png 1127w" sizes="(max-width: 1024px) 100vw, 1024px" /></figure>



<p><a href="https://biotickr.com/biotech-stocks/united-states-of-america/aqst-aquestive-therapeutics-inc">AQST </a>believes – the drug efficacy tends to be higher upon administration via the novel drug delivery platform.</p>



<p>Some of the drugs that AQST markets are Sympazan, an oral film formulation of Clobazam for the treatment of Lennox-gastaut syndrome (LGS), Suboxone, a sub-lingual film formulation of buprenorphine and naloxone for the management of opioid dependence, Zuplenz, a soluble film formulation of ondansetron for management of chemotherapy and postoperative nausea and vomiting and Azstarys for treatment of attention-deficit hyperactivity disorder. Exservan (Riluzole) for amyotrophic lateral sclerosis. Libervant is the&nbsp;<a href="https://aquestive.com/aquestive-therapeutics-receives-fda-tentative-approval-for-libervant-diazepam-buccal-film/" target="_blank" rel="noreferrer noopener">proprietary</a>, oral soluble film formulation of diazepam for seizures; Libervant has received tentative approval from the USFDA. Other pipelines include AQST-108, AQST-305, AQST-109, and KYNMOBI for the treatment of emergencies other than anaphylaxis, acromegaly, allergic reactions including anaphylaxis, and management of episodic off-periods in Parkinson’s disease, respectively.&nbsp;</p>



<h2><strong>Recent events</strong></h2>



<p><strong>December 22nd, 2022</strong> &#8211; Aquestive Therapeutics&nbsp;<a rel="noreferrer noopener" href="https://finance.yahoo.com/news/aquestive-therapeutics-announces-completion-fda-130000946.html" target="_blank">announced</a>&nbsp;completion of FDA End-of-Phase 2 meeting for AQST-109 (epinephrine sublingual film)</p>



<p><strong>November 10th, 2022</strong> &#8211; Aquestive Therapeutics to present&nbsp;<a rel="noreferrer noopener" href="https://finance.yahoo.com/news/aquestive-therapeutics-present-positive-data-213300949.html" target="_blank">positive</a>&nbsp;data from pharmacokinetic studies for AQST-109 (epinephrine sublingual film) at the American Academy of Allergy, Asthma, and Immunology (ACAAI) Annual Scientific Meeting</p>



<p><strong>November 2nd, 2022</strong> &#8211; Aquestive Therapeutics&nbsp;<a rel="noreferrer noopener" href="https://finance.yahoo.com/news/aquestive-therapeutics-reports-third-quarter-200100950.html" target="_blank">reported</a>&nbsp;third-quarter 2022 financial results and provides a business update.</p>



<p><strong>October 27th, 2022</strong> &#8211; Aquestive Therapeutics&nbsp;<a rel="noreferrer noopener" href="https://finance.yahoo.com/news/aquestive-therapeutics-licenses-sympazan-clobazam-130500546.html" target="_blank">licensed</a>&nbsp;Sympazan® (clobazam) oral film to Assertio Holdings, Inc.</p>



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



<p><strong>ALS:</strong></p>



<p>In 2020, the global ALS treatment market was USD 513 million and&nbsp;<a href="https://www.researchandmarkets.com/reports/5357405/global-amyotrophic-lateral-sclerosis-als" target="_blank" rel="noreferrer noopener">is forecasted</a>&nbsp;to reach USD 762.3 million by 2027.</p>



<p><strong>Seizures associated with Lennox-Gastaut syndrome (LGS):&nbsp;</strong></p>



<p>The LGS treatment market is&nbsp;<a href="https://www.technavio.com/report/lennox-gastaut-syndrome-treatment-market-industry-analysis#:~:text=The Lennox-Gastaut Syndrome (LGS,at a CAGR of 4.42%." target="_blank" rel="noreferrer noopener">expected</a>&nbsp;to reach USD684.75 between 2021 and 2026 at a CAGR of 4.42%.&nbsp;</p>



<p><strong>Vomiting:</strong></p>



<p>The global vomiting and nausea treatment market was USD4883.4 million in 2020, which is&nbsp;<a href="https://www.globenewswire.com/news-release/2022/05/26/2451345/0/en/At-6-5-CAGR-Nausea-and-Vomiting-Treatment-Market-Size-to-Surpass-USD-7580-9-Million-by-2027-Nausea-and-Vomiting-Treatment-Industry-Worldwide-Industry-Demand-Regional-Overview-Trend.html" target="_blank" rel="noreferrer noopener">projected</a>&nbsp;to reach USD7580.9 million by 2027.&nbsp;</p>



<p><strong>Parkinson’s disease:</strong></p>



<p>In 2021, the global Parkinson’s disease treatment&nbsp;<a href="https://www.coherentmarketinsights.com/market-insight/parkinsons-disease-therapeutic-market-494" target="_blank" rel="noreferrer noopener">market</a>&nbsp;was USD 4697.3 million and is expected to increase at a rate of 6.3% from 2021 to 2028.&nbsp;</p>



<p><strong>Attention deficit hyperactivity disorder (ADHD):</strong></p>



<p>The global ADHD treatment market was&nbsp;<a href="https://www.coherentmarketinsights.com/market-insight/attention-deficit-hyperactivity-disorder-treatment-market-830" target="_blank" rel="noreferrer noopener">valued</a>&nbsp;at USD 2018.1 million and is forecasted to increase at the rate of 7.1% between 2020 and 2030.&nbsp;</p>



<p>The global&nbsp;<a href="https://www.alliedmarketresearch.com/opioids-market" target="_blank" rel="noreferrer noopener">market</a>&nbsp;size of medical opioids was USD 4.4 billion in 2020 and is expected to reach USD 6.1 million by 2030 at a CAGR of 3.2% between 2021 and 2030.&nbsp;</p>



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



<p>By Q3 2022, the total revenue was USD 11.5 million, compared to USD 13.3 million in Q3 2021. While the company reported a 15% increase in Sympazan net revenue, the net loss for Q32022 was USD 12.5 million due to a decrease in interest expenditure, and decrease in R&amp;D expenses and cost, etc.</p>



<p>As of September 2022, the net cash and cash equivalents were USD 18.6 million.</p>



<p>The total revenue in 2022 was USD 46-49 million and non-GAAP adjusted EBITDA loss was USD 37-43 million. Not so appreciable revenue, considering the company’s novel treatment approach!&nbsp;&nbsp;</p>



<p>The revenue generated says all about the market potential of the drugs and clinical viability. Maybe, the old wine in the new bottle approach fails to work.</p>



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



<figure class="wp-block-image size-full"><img decoding="async" loading="lazy" width="716" height="79" src="https://author.biotickr.com/wp-content/uploads/2023/01/image-3.png" alt="" class="wp-image-52" srcset="https://author.biotickr.com/wp-content/uploads/2023/01/image-3.png 716w, https://author.biotickr.com/wp-content/uploads/2023/01/image-3-300x33.png 300w" sizes="(max-width: 716px) 100vw, 716px" /></figure>



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



<p>Like <a href="https://biotickr.com/biotech-stocks/united-states-of-america/aqst-aquestive-therapeutics-inc">AQST</a>, Eagle Pharmaceuticals has been&nbsp;<a rel="noreferrer noopener" href="https://www.eagleus.com/pipeline/" target="_blank">developing</a>&nbsp;small molecule pipelines for various unmet needs including nerve-agent-induced brain damage. Other portfolio includes Ryanodex (Dantrolene sodium), vasopressin, Pemetrexed injection, Fulvestrant, Belrapzo (bendamustine) injection, and Bendeka (bendamustine) injection.</p>



<p><a href="https://biotickr.com/biotech-stocks/united-states-of-america/hrtx-heron-therapeutics-inc">Heron Therapeutics</a> is developing a variety of oncology care solutions such as Sustol (Ganisedron) injection and Cinvanti (Aprepitant) injectable solutions, in addition to, acute care solutions including Zynrelef (bupivacaine and meloxicam) solution, Aponvie (aprepitant) injectable emulsion and HTX-034 (bupivacaine, meloxicam, and aprepitant) injectable solutions. Except for HTX-034, other portfolio drugs are in the commercial stage.&nbsp;</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="AQST Biotickr Summary" width="500" height="281" src="https://www.youtube.com/embed/smqMqNjMyC0?feature=oembed" frameborder="0" allow="accelerometer; autoplay; clipboard-write; encrypted-media; gyroscope; picture-in-picture; web-share" allowfullscreen></iframe>
</div></figure>



<p><a href="https://biotickr.com/biotech-stocks/united-states-of-america/aqst-aquestive-therapeutics-inc">AQST</a> has a plethora of assets in their pipeline for various indications, all of which existing drugs being tried in a new proprietary platform to achieve better drug delivery and improved treatment success. They have been making deals to generate cash to help develop their epinephrine candidate, AQST-109. <a href="https://biotickr.com/biotech-stocks/united-states-of-america/aqst-aquestive-therapeutics-inc">Aquestive</a> appears to be going all-in on AQST-109’s clinical and commercial success.</p>



<p>Retail loves AQST, some comments from twitter:<br><em>&#8220;JMP Securities analyst Jason Butler reiterated a Buy rating on Aquestive Therapeutics today and set a price target of $7.00. The company’s shares closed last Friday at $0.89, close to its 52-week low of $0.62&#8221;</em></p>



<p>&#8220;<em>invest for 2025 for buccal film epinephrine, 700%-1000% upside pending FDA approval</em>&#8220;</p>



<p>The initiation of Phase III AQST-109 (epinephrine sublingual film) is expected by early Q2 2023, and no other near-term catalysts are available for short-term investment.&nbsp; &nbsp;</p>



<h1>&nbsp;</h1>


Quicktake – Aquestive Therapeutics (AQST)


<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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