$AYTU “Penny Stock 101” Promoter Rank: 19/25 Aytu BioPharma, Inc. Newsletter 6:09:26 PM September 14, 2021

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AYTU Promotional Newsletter

The following is a newsletter released by "Penny Stock 101" promoting Aytu BioPharma, Inc.


The following newsletter has not been verified for accuracy or completeness.

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Closing Price $3.08

Analyst Price Target $24.00


We've just identified an amazing oversoldundervalued opportunity trading on the NASDAQ.

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Aytu BioScience, a pharmaceutical company whose primary focus is meeting the needs of children with pediatric onset conditions. The company has a of approved products in prescription therapeutics and consumer healthcare, and is even working on treatments for COVID-19. Even with a revenue-generating portfolio, however, AYTU shares have fallen 42% in the last 3 months.

The drop in share price has come despite a 64% year-over-year gain in the companys revenue stream. This included an increase in consumer health revenues during the fiscal third quarter coinciding with the calendar Q1 from $3.5 million to $8.4 million yoy, and in prescription revenues from $4.7 million to $5.1 million. The company attributed the strong consumer health performance the division revenues were a company record to a combination of product launches and e-commerce sales.

Aytus net loss, however, drew even as revenues were solid. At $1.41 per share, the net loss was almost as deep as in the year-ago quarter, and nearly double the 72-cent loss reported in F2Q21. Aytu attributed the increase in net loss to costs associated with its .

That merger deal was announced in December and closed this past March. The transaction, conducted all in stock, was worth $44.9 million and made Neos into a wholly-owned subsidiary of Aytu. The costs of the Neos merger were front-loaded for Aytu, and included a $15 million payment toward the debt notes held by Neos but Aytu expects to realize gains of $15 million annually starting in fiscal year 2022 2H CY21.

Finally, during fiscal Q3, Aytu added a new drug to its development pipeline, AR101, a new treatment for Vascular Ehlers Danlos syndrome vEDS. This is a severe, pediatric-onset, genetic condition, causing weakening and splitting of the blood vessels and internal organs. Aytu acquired a global license for development of AR101 from Rumpus Therapeutics, and plans to submit an Investigational New Drug application to the FDA in 2H21. The company expects a pivotal study to begin in 1H22.

All of this adds up to a sound foundation for the stock, according to 5-star analyst , of H.C. Wainwright. Bernardino rates AYTU shares a Buy along with a $24 price target. Should his thesis play out, a potential upside of 679% could be in the cards. To watch Bernardinos track record,

About Aytu BioPharma, Inc.

Aytu BioPharma is a specialty pharmaceutical company with a growing commercial portfolio of prescription therapeutics and consumer health products. The company's primary prescription products treat attention deficit hyperactivity disorder ADHD and other common pediatric conditions. Aytu markets ADHD products Adzenys XR-ODT amphetamine extended-release orally disintegrating tablets , Cotempla XR-ODT methylphenidate extended-release orally disintegrating tablets, and Adzenys-ER amphetamine extended-release oral suspension . The company's other pediatric products include Karbinal ER carbinoxamine maleate, an extended-release carbinoxamine antihistamine suspension indicated to treat numerous allergic conditions, and Poly-Vi-Flor and Tri-Vi-Flor, two complementary fluoride-based prescription vitamin product lines containing combinations of fluoride and vitamins in various formulations for infants and children with fluoride deficiency. The company's evolution has been driven by strategic in-licensing, acquisition-based transactions and organic product growth. Aytu is building a complimentary therapeutic development pipeline including a prospective treatment AR101enzastaurin for vascular Ehlers-Danlos Syndrome VEDS, a rare genetic disease resulting in high morbidity and a significantly shortened lifespan. VEDS is a devastating condition for which there are no currently approved treatments. AR101 is an orally available investigational first-in-class small molecule, serinethreonine kinase inhibitor of the PKC beta, PI3K and AKT pathways. AR101 has been studied in more than 3,300 patients across a range of solid and hematological tumor types, and we are now planning a randomized, controlled, pivotal clinical study with AR101 in VEDS. To learn more, please visit aytubio.com.


AR101 enzastaurin is a pivotal study-ready therapeutic candidate initially targeting the treatment of vascular Ehlers-Danlos Syndrome VEDS

Study being conducted using endotracheal UVA application on COVID-19, to determine safety and efficacy of novel approach to antimicrobial treatment via phototherapy on internal organs.

Proprietary microparticle delivery technology allows modified-release drug delivery of active pharmaceutical ingredient and has the potential to provide meaningful clinical improvement for a variety of disease states.

Product in development for the treatment of Sialorrhea drooling or excessive salivation as a result of limitations in a persons ability to control and swallow oral secretions.

The Company announced that data from a first in-human, open label, clinical trial in SARS-CoV-2 patients has been released.

The pre-print publication titled Endotracheal application of ultraviolet A light in critically ill severe acute respiratory syndrome coronavirus-2 patients A first-in-human study concluded that endotracheal UVA light treatment was associated with a significant reduction of SARS-CoV-2 viral load and improvement in WHO clinical severity scores. Additionally, the endotracheal UVA light treatment did not result in any serious adverse device effects and was well tolerated.

A total of five critically ill, mechanically ventilated COVID-19 patients underwent UVA light therapy for five consecutive days. The UVA light catheter was inserted into an endotracheal tube ETT and illuminated for 20 minutes during each treatment. The endotracheal ET treatment resulted in significant logarithmic reduction of the SARS-CoV-2 viral load of the ET aspirate, which was the study's primary endpoint. Average log changes from baseline to day five and day six were -2.41 99%, p0.0018 and -3.2 99.9%, p0.0005, respectively. WHO clinical severity scores improved by an average of 1.6 and 3.6 points on day 15 and day 30, respectively. Excluding subject two, who had undetectable viral load, WHO clinical severity scores improved by 4.75 points on day 30. Importantly, no serious adverse device effects were observed, and no early treatment discontinuation occurred.

Josh Disbrow, Chief Executive Officer of Aytu BioScience, commented, We believe the Healight technology can become an important tool for fighting the global COVID-19 pandemic, and we look forward to continuing discussions with the FDA on the advancement of this technology. There may be additional anti-infective applications for Healight beyond COVID-19, so having this initial proof of concept data gives us a great deal of enthusiasm for the potential of this investigational device. I would like to thank the team and our collaborators for the work that went into conducting this study and generating this data.

Aside from coronavirus, utilization of internal UVA light may have numerous other respiratory applications. Aytu BioScience will continue to engage with researchers in multiple therapeutic areas to continue to build on this technology platform.

The data have been published in MedRxiv, an online archive for health science pre-print manuscripts that are not yet peer reviewed. The manuscript has been submitted for peer review.

The complete study manuscript can be accessed at

AYTU announced that data from a laboratory study evaluating the ultraviolet A light used in the Healight endotracheal catheter technology was published in the peer reviewed journal Photodiagnosis and Photodynamics Therapy.

These latest in vitro findings continue to build upon the body of scientific evidence supporting the potential of this UVA platform technology and may help to explain the observed effects of Healight in SARS-CoV-2. These findings point to the fact that UVA light demonstrated a statistically significant effect on several key secreted cytokines and chemokines that are upregulated during CoV-229E induced cytokine secretion, which may translate to a clinical benefit in SARS-CoV-2. This in vitro finding supports the further pursuit of Healight as a prospective treatment for severely ill intubated patients with difficult to treat respiratory infections, including SARS-CoV-2, commented Josh Disbrow, Chief Executive Officer of Aytu BioPharma. We continue to believe in the potential clinical utility of this treatment and look forward to initiating a larger, sham-controlled Phase 2 clinical study in Europe in the second half of 2021.

The manuscript titled Ultraviolet-A light reduces cellular cytokine release from human endotracheal cells infected with Coronavirus concluded that that repeated narrow band UVA NB-UVA therapy may mitigate excessive immune system signaling by cells infected with human coronavirus. The study demonstrated that NB-UVA therapy decreases the level of several pro-inflammatory secreted cytokineschemokines in an in vitro model studying CoV-229E that partially mimics the cytokine storm commonly caused by coronavirus.

Data from this study show that transfection with CoV-229E which is related to the SARS-CoV-2 virus implicated in COVID-19 results in excessive cytokine production in human ciliated tracheal epithelial cells in vitro, and that these cytokines are significantly ameliorated following repeated treatment with specific and monitored UVA light therapy. Levels of secreted pro- and anti-inflammatory cytokineschemokines were analyzed in supernatants harvested from coronavirus-infectedUVA-exposed cells 24 hours after the last UVA treatment, and from matched non-infectedUVA-exposed controls, coronavirus-infectednon-exposed controls, and non-infectednon-exposed naïve controls.

Pro-inflammatory cytokines interleukin IL-6 and tumor necrosis factor TNF, and chemokines IL-8, monocyte chemoattractant protein-1 MCP1, and interferon gamma-induced protein 10 IP-10, were significantly increased in CoV-229E-infected cells, but significantly decreased following NB-UVA treatment. Specifically, NB-UVA treatment significantly reduced secreted levels of IL-6 and TNF-α by at least 50%. These are two major cytokines associated with the activation of the systemic immune system and inflammatory responses and are highly correlated with COVID-19 severity and patient survival.

Aside from coronavirus, utilization of internal UVA light may have numerous other clinical applications. Aytu BioPharma will continue to engage with researchers in various therapeutic areas to continue to build on this technology platform.

Healight Platform Overview

First-in-class UV-light based antimicrobial catheter In vitro and in vivo studies demonstrate broad antimicrobial activity against a range of pathogens including coronavirus

Worldwide license from Cedars-Sinai Medical Center In development since 2016 at Medical Associated Science Technology Program

Patents filed in key markets globally Multiple patent families terms extend to 2040

International sham-controlled study being planned in COVID-19 patientsVentilator Associated Pneumonia VAP

Recently announced positive clinical data from pilot study Average log changes from baseline to day 5 and day 6 were -2.41 99%, p0.0018 and -3.2 99.9%, p0.0005, respectively WHO clinical severity scores improved by an average of 1.6 and 3.6 points on day 15 and day 30, respectively

AYTU Sees Strong Revenue Growth

Net revenue was $13.5 million, compared to $8.2 million in the same quarter last year. The company continues to increase sales through both organic product growth and through the realization of the recently-completed Neos transaction.

Net revenue from the consumer health division was $8.4 million, an increase over the $3.5 million in the same quarter last year. Consumer health growth was driven primarily by multiple product launches and growth of the e-commerce channel.
Net revenue from the Rx division was $5.1 million, an increase over the $4.7 million in the same quarter last year and includes the product revenue contributed from Neos only for the period following the close of the merger on March 19, 2021.

Recent Corporate and Pipeline Highlights

Expanded development pipeline with pivotal study-ready protein kinase C β isoform PKCβ inhibitor, AR101 enzastaurin, for rare disease indications In April 2021, Aytu announced the acquisition of a global license to AR101 enzastaurin, a pivotal study-ready therapeutic candidate initially targeting the treatment of vascular Ehlers-Danlos Syndrome vEDS from Rumpus Therapeutics, a privately-held biopharmaceutical company focused on the treatment of pediatric onset rare and orphan diseases. vEDS is a rare genetic disorder typically diagnosed in childhood and characterized by arterial aneurysm, dissection and rupture, bowel rupture and rupture of the gravid uterus. There are currently no U.S. Food and Drug Administration FDA-approved treatments for vEDS.

Closed merger with Neos Therapeutics In March 2021, Aytu announced the close of its merger with Neos Therapeutics, putting it in a strong position to enhance its footprint in pediatrics and expand its presence in adjacent specialty care segments. The company expects to begin realizing estimated annualized cost synergies of $15.0 million in fiscal year 2022. As part of the go forward plan for the newly combined company to best serve its patients, management evaluated the operations cost structure and concluded that moving to a production outsourcing strategy for the company's ADHD products is expected to result in a more efficient supply and lower conversion cost of these ADHD products. As such, the company plans to close its Grand Prairie, Texas manufacturing operations over the next eighteen months as it completes the technology transfer of the production process.

Published in vitro data demonstrating ultraviolet-A light increases mitochondrial anti-viral signaling protein within cells In May 2021, Aytu announced the publication of in vitro data related to the ultraviolet A UVA light used in the Healight UVA endotracheal catheter technology in bioRxiv. The manuscript titled Ultraviolet-A light increases mitochondrial anti-viral signaling protein via cell-cell communication concluded that UVA light increases the expression of mitochondrial antiviral-signaling MAVS protein within cells, and the results suggest that this transmission of an increase in intracellular MAVS involves cell-to-cell communication. These findings confirm that an increase of MAVS in response to UVA light can be transmitted from cells directly exposed to UVA light to neighboring cells that have not been directly exposed to UVA light.

Reported positive clinical results from pilot study of Healight UVA light catheter technology in SARS-CoV-2 patients In March 2021, the company reported data from a first in-human, open label, clinical trial in SARS-CoV-2 patients. The data show that endotracheal UVA light treatment was associated with a significant reduction of SARS-CoV-2 viral load and improvement in WHO clinical severity scores. Additionally, the endotracheal UVA light treatment did not result in any serious adverse device effects and was well tolerated. The data was published in MedRxiv, and a manuscript has been submitted for peer review.

Sold rights to Natesto to Acerus Pharmaceuticals Corporation for $7.5 million In April, the company announced that it signed an agreement with Acerus whereby Acerus would acquire all remaining rights to Natesto in the United States from Aytu. In consideration, Aytu will received $7.5 million in cash from Acerus, which is payable in equal monthly payments of $250,000 over 30 months. Additionally, Acerus has assumed all product responsibilities associated with Natesto as of April 1, 2021.

Appointed Richard Eisenstadt as chief financial officer In April 2021, the company appointed Richard Eisenstadt as chief financial officer. Mr. Eisenstadt is an accomplished pharmaceutical industry executive with more than 20 years of experience in leading finance and accounting operations, supporting clinical development and commercialization, and raising capital within the life sciences sector. He was most recently CFO of Neos Therapeutics.

Substantially expanded management team In April 2021, the company added Rumpus Therapeutics co-founders and principal executive officers, Topher Brooke and Nate Massari as executive vice presidents and will be responsible for the AR101 program and the development of the company's pediatric onset rare disease pipeline.

Anticipated Milestones

Continue discussions with the FDA and other regulatory agencies regarding the advancement of its Healight UVA light catheter technology.
RxConnect platform expansion Rx and revenue growth
Realization of $15M in Neos merger synergies FY2022
Initiate Phase 2 trial of Healight in COVID-19 1H FY2022
Receipt of Orphan Designation for AR101 1H FY2022
File IND for AR101 for VEDS 1H FY2022
Launch AR101 pivotal study 2H FY2022
Manufacturing transfer and accompanying gross margin improvement of ADHD brands FY2023


The Bottom Line

As you can see, AYTU is a company with a bright future ahead of it.

We believe the downtrend is nearly over, and that a massive price reversal could take place in the near future.

With growing revenues and a strong pipeline, AYTU could be the steal of the year at these levels.

That being said, we suggest that you start your research on AYTU, and immediately add it to the top of your watchlist.

Best Regards,

The PennyStock101 Team

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