Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
So what. Just more hype. Good luck with any real sales over next 5-7 years
NEWS -- Aytu BioPharma Announces Publication of In Vitro Study Demonstrating That Ultraviolet-A Light Increases Mitochondrial Anti-Viral Signaling Protein Within Cells
ENGLEWOOD, CO / ACCESSWIRE / May 12, 2021 / Aytu BioPharma, Inc. (NASDAQ:AYTU), a specialty pharmaceutical company focused on commercializing novel therapeutics and consumer healthcare products, announced today that in vitro data related to the ultraviolet (UV) A light used in the Healight™ UVA endotracheal catheter technology was published in BioRxiv, an online archive for health science manuscripts that are not yet peer reviewed.
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 and suggest that cell-to-cell signaling is involved in the process of eliciting UVA light's antiviral effect.
"These latest findings continue to build upon the potential of the UVA light platform technology and may reveal the fundamental basis for the therapeutic effect of the specific UVA light used in the Healight endotracheal catheter . These findings point to the fact that direct exposure of cells to UVA light may not be required to elicit an antiviral effect against a pathogen like SARS-CoV-2 because the mitochondrial activation results in a wide-ranging cell-to-cell response which could result in an increased antiviral effect, "commented Josh Disbrow, chief executive officer of Aytu BioPharma.
In the study, MAVS levels were compared in primary human tracheal epithelial cells (HTEpC) exposed to narrow band (NB)-UVA light for 20 minutes and in unexposed controls, at 30-40% and at 100% cell culture confluency. MAVS levels were also compared in unexposed HTEpC cells treated with supernatants or lysates from UVA-exposed cells or from unexposed controls, and in cells from different sections of confluent monolayer plates where only one section of the plate was exposed to NB-UVA. This study did not test the use of the actual Healight device to treat COVID-19, the disease caused by the SARS-CoV-2 virus.
Normalized MAVS levels, as detected by western blot, were increased in NB-UVA exposed cells when compared to unexposed controls (P=0.0193). There were no changes in normalized MAVS levels, when naïve 30-40% confluent HTEpC cells were treated with supernatants or cell lysates from NB-UVA exposed 30-40% confluent HTEpC cells (P=0.4022, P=0.1256). Normalized MAVS levels gradually increased from section 4 (farthest unexposed area) through section 1 (closest area exposed to NB-UVA) (P=0.08), and there was a significant increase in MAVS levels in section 1 (exposed to NB-UVA) when compared to unexposed section 4 (P=0.0382).
About MAVS
Mitochondrial antiviral-signaling protein (MAVS) is a protein that is essential for antiviral innate immunity. MAVS is located in the outer membrane of the mitochondria, peroxisomes, and endoplasmic reticulum (ER). Upon viral infection, a group of cytosolic proteins will detect the presence of the virus and bind to MAVS, thereby activating MAVS. The activation of MAVS leads the virally infected cell to secrete cytokines. This induces an immune response which kills the host's virally infected cells, resulting in clearance of the virus.
To access the BioRxiv pre-print, click here:
https://www.biorxiv.org/content/10.1101/2021.05.11.443549v1
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 (see Full Prescribing Information, including Boxed WARNING), Cotempla XR-ODT® (methylphenidate) extended-release orally disintegrating tablets (see Full Prescribing Information, including Boxed WARNING), and Adzenys-ER® (amphetamine) extended-release oral suspension (see Full Prescribing Information, including Boxed WARNING). 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 (AR101/enzastaurin) for vascular Ehlers-Danlos Syndrome (vEDS), a rare genetic disease resulting in high morbidity and a significantly shortened lifespan. There are no currently approved treatments for vEDS. To learn more, please visit https://aytubio.com.
Forward-Looking Statements
This press release includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, or the Exchange Act. All statements other than statements of historical facts contained in this press release, are forward-looking statements. Forward-looking statements are generally written in the future tense and/or are preceded by words such as ''may,'' ''will,'' ''should,'' ''forecast,'' ''could,'' ''expect,'' ''suggest,'' ''believe,'' ''estimate,'' ''continue,'' ''anticipate,'' ''intend,'' ''plan,'' or similar words, or the negatives of such terms or other variations on such terms or comparable terminology. All statements other than statements of historical facts contained in this presentation, are forward-looking statements, including but not limited to any statements regarding the scientific or clinical results from the Healight studies, the potential regulatory authorizations or approvals that may be enabled by such studies, the market potential of Healight, and any factors that could influence any future commercialization plans for Healight t We also refer you to (i) the risks described in ''Risk Factors'' in Part I, Item 1A of Aytu's Annual Report on Form 10-K and in the other reports and documents it files with the Securities and Exchange Commission and (ii) the Risk Factors set forth in Aytu's Annual Report on Form 10-K and Quarterly Reports on Form 10-Q filed with the SEC.
Contact for Media and Investors:
Sarah McCabe
Stern Investor Relations, Inc.
mailto://sarah.mccabe@sternir.com
SOURCE: Aytu BioPharma, Inc.
View source version on accesswire.com:
https://www.accesswire.com/646801/Aytu-BioPharma-Announces-Publication-of-In-Vitro-Study-Demonstrating-That-Ultraviolet-A-Light-Increases-Mitochondrial-Anti-Viral-Signaling-Protein-Within-Cells
NEWS -- Aytu BioPharma to Report Third Quarter Fiscal 2021 Results on May 17, 2021
ENGLEWOOD, CO / ACCESSWIRE / May 10, 2021 / Aytu BioPharma, Inc. (NASDAQ:AYTU), a specialty pharmaceutical company focused on commercializing novel therapeutics and consumer healthcare products, announced today that it will host a conference call and live webcast on Monday, May 17, 2021, at 4:30 p.m. ET to report its financial results for the fiscal third quarter ended March 31, 2021 and review recent accomplishments.
Conference Call Information
877-407-9124 (toll-free)
201-689-8584 (international)
The webcast will be accessible live and archived at the following link https://www.webcaster4.com/Webcast/Page/2142/40724 and on Aytu BioPharma's website, within the Investors section under Events & Presentations, at https://aytubio.com, for 90 days.
A replay of the call will be available for fourteen days. Access the replay by calling 1-877-481-4010 (toll-free) or 919-882-2331 (international) and using the replay access code 40724.
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 (see Full Prescribing Information, including Boxed WARNING), Cotempla XR-ODT® (methylphenidate) extended-release orally disintegrating tablets (see Full Prescribing Information, including Boxed WARNING), and Adzenys-ER® (amphetamine) extended-release oral suspension (see Full Prescribing Information, including Boxed WARNING). 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 (AR101/enzastaurin) for vascular Ehlers-Danlos Syndrome (vEDS), a rare genetic disease resulting in high morbidity and a significantly shortened lifespan. There are no currently approved treatments for vEDS. To learn more, please visit https://aytubio.com.
Contact for Media and Investors:
Sarah McCabe
Stern Investor Relations, Inc.
mailto://sarah.mccabe@sternir.com
SOURCE: Aytu BioPharma, Inc.
View source version on accesswire.com:
https://www.accesswire.com/646144/Aytu-BioPharma-to-Report-Third-Quarter-Fiscal-2021-Results-on-May-17-2021
Wow. A2, the forgotten stock. Should be a documentary made on what happens when poor management hops in bed with crooked hedge fund guys.
I remember the good old days, when news of that CV test had Fox News guy, Rob Low's heart all aflutter for Josh, and there were 200 posts per minute on the message boards.
Well, I'm sure all of the Dimbrows are at least living high on the hog, fine dining and wine, maybe some new mountain cabins.......in the Swiss Alps?
What a sham(e).
Well I remember being blasted for speaking/revealing the truth last year, based on my prior experience with this schittshow.
Btw, has that slow boat from China ever arrived at Denver International with those test kits?
Good posts. Company won't be profitable and more dilutio along with another RS within 2.5 years. Nothing more than a piggy bank for insiders.
oh i found it... Stock and or cash will be paid if certain revenue or profitability is achieved within 5 years. Cant get anymore concrete than that.
(if, maybe, possible, certain, depending). yes your love of a company AYTU provided this deal with scam innv and chewed up innocent shareholders. It will happen to all of you when they sell themselves off to another pos scam “potential company”
Does anyone know what the conditions or expiration dates are on the INNV cvr’s? Or should they just be completely forgotten about because they were BS?! I completely forgot about those. Just saw them in my portfolio and started laughing.
Oh INNV... what a scam that was lol
Anyone know why they paid us yesterday?
Taking on more debt with revs that don't cover the additional expenses. Look for more significant dilution over the next 12 months. I'm still sticking with RS within the next 2.5 yrs.
NEWS -- Aytu BioPharma Adds Late-Stage Pediatric Onset Rare Disease Asset to Development Pipeline from Rumpus Therapeutics
ENGLEWOOD, CO / ACCESSWIRE / April 12, 2021 / Aytu BioPharma, Inc. (NASDAQ:AYTU), a specialty pharmaceutical company focused on commercializing novel therapeutics and consumer healthcare products, today 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 (Rumpus), 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.
"This acquisition positions us to greatly accelerate our growth plans both through the addition of this novel rare disease asset to our development pipeline, as well as the expansion of our management team with co-founders Topher Brooke and Nate Massari joining the team. As we seek to expand our high-value pipeline of late-stage assets, and grow our commercial products, this milestone further solidifies our position as a leading pediatric specialty pharmaceutical company," commented Josh Disbrow, Chief Executive Officer of Aytu BioPharma. "The AR101 program is expected to progress directly to a single pivotal study, and the Rumpus team has employed numerous strategies in the development plan to minimize clinical risk associated with the trial. We are greatly encouraged by the potential speed to FDA approval, especially as we believe it can provide much needed hope for vEDS patients and their families."
"I'm excited to get to work on this important late-stage program and draw from the deep expertise of both Topher and Nate. Both of these executives have distinguished careers in rare disease, business development, and strategic planning across a range of leading pharmaceutical companies and I'm pleased to welcome them to the Aytu team," continued Mr. Disbrow.
Terms of the Transaction
Under the terms of the transaction, Aytu has acquired the vEDS enzastaurin program of Rumpus and all associated intellectual property for $1.5 million upfront in cash. In addition, Aytu paid fees associated with the transfers of third-party licenses from Rumpus to Aytu and will take over any royalty obligations under these licenses. Aytu has also agreed to make performance-based milestone payments to Rumpus upon the achievement of regulatory, clinical and commercial milestones. The Company will pay up to $22.5 million in milestone payments if certain regulatory milestones are met, including $15.0 million in milestone payments if AR101 receives approval by the FDA and another major market regulatory authority. Commercial milestones of up to an additional $45.0 million may be paid if a series of global commercial milestones are met over the life of the product. All milestone consideration may be paid in any combination of cash or stock at the Company's option, with the provision that shares will not be issued in excess of 19.9% of the now-outstanding shares of Aytu unless subsequently approved by Aytu's shareholders.
Rumpus Therapeutics co-founders and principal executive officers, Topher Brooke and Nate Massari, will join the Aytu executive team and report to CEO, Josh Disbrow. Both Mr. Brooke and Mr. Massari will lead all aspects of the AR101 vEDS program and the further development of the Company's pediatric onset rare disease pipeline.
Nate Massari has more than 20 years of healthcare experience in consulting, in-line marketing and sales, pipeline marketing, corporate strategy, sales management and corporate development across the pharmaceutical, biotech, device, health services, and distribution industries. He began his career in management consulting within the Health & Life Sciences practice at Accenture. Nate also held various leadership roles at Johnson & Johnson, AstraZeneca, Endo Pharmaceuticals, and AmerisourceBergen. He has completed numerous business development transactions totaling over $6 billion in capital deployment, and his rare disease expertise includes launching pediatric inflammatory bowel disease indications while at Johnson & Johnson as well as leading the orphan drug pediatric endocrinology franchise at Endo Pharmaceuticals. Most recently, Nate co-founded Rumpus Therapeutics to develop new medicines for pediatric onset rare and orphan diseases. Nate has a BA from Princeton University and an MBA from the Wharton School at the University of Pennsylvania.
Christopher "Topher" Brooke has over 20 years of general management experience in healthcare across all phases of development and commercialization. He has depth of experience from target selection and clinical development planning through running several blockbuster commercial pharmaceutical franchises. He has worked across several modalities (proteins, small molecules and vaccines) and across multiple therapeutic areas. Topher has held roles of increasing responsibility at Johnson & Johnson, AstraZeneca, and AmerisourceBergen. His rare disease experience includes launching pediatric inflammatory bowel disease indications while at Johnson & Johnson as well as leading the pediatric infectious disease franchise at AstraZeneca. Topher went on to lead the fully integrated Diabetes Division at AstraZeneca. Most recently, Topher co-founded Rumpus Therapeutics to develop new medicines for pediatric onset rare and orphan diseases. Topher has a BA from Colgate University and an MBA from the Wharton School at the University of Pennsylvania.
The landmark research supporting AR101 was conducted by Dr. Hal Dietz, Professor of Genetic Medicine at Johns Hopkins University School of Medicine and an Investigator at the Howard Hughes Medical Institute.
"I have dedicated my career to researching and treating patients with connective tissue disorders, and these efforts include vascular Ehlers-Danlos Syndrome and Marfan Syndrome. In particular with vEDS, patients face catastrophic vascular events without warning. There are no currently approved therapies, but our research has shown that a clear pathway exists to potentially beat this disease. Our aim is to prove that in a well-controlled clinical trial, which we hope will be underway soon," commented Dr. Hal Dietz.
Dr. Josephine Grima, Chief Science Officer of The Marfan Foundation, and Katie Wright, Director of The VEDS Movement, a division of the Foundation, added, "The unmet need for people with VEDS is massive. Many of these individuals find out they have the condition via genetic testing after suffering severe medical complications, and some find out after losing family members who weren't even diagnosed yet. Currently, there are no therapies proven to prevent the life-threatening emergencies that can occur. We are thrilled to partner with Aytu by providing education and awareness to physicians, patients and families to help maximize the success of this trial."
Lara Bloom, CEO of the Ehlers-Danlos Society added, "This community is thirsting for additional research across all types of Ehlers-Danlos Syndromes. It's also a mobilized and well-connected community that is excited to participate in advancing research and clinical development."
About vascular Ehlers-Danlos Syndrome (vEDS)
Vascular Ehlers Danlos Syndrome (vEDS) is the severe subtype of Ehlers-Danlos Syndrome, affecting 1 in 50,000 people worldwide and results from pathogenic variants in the COL3A1 gene, which encodes the chains of type III procollagen, a major protein in vessel walls and hollow organs. Twenty-five percent of vEDS patients have a first complication by the age of 20 years, and more than eighty percent have at least one complication by the age of 40. vEDS is a devastating condition, and vEDS patients have a median lifespan of 51 years. There are no FDA-approved therapies for vEDS.
About AR101 (enzastaurin)
AR101 (enzastaurin) is an orally available investigational first-in-class small molecule, serine/threonine 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. Dr. Hal Dietz developed the first preclinical model that mimics the human condition and recapitulates vEDS. This knock-in model has the same genetic mutation most prevalent in vEDS patients and is representative of the human condition in both the timing and location of vascular events. The model has generated identical structural histology and mechanical characteristics, and unbiased findings demonstrated that structure alone does not lead to vascular events. Objective comparative transcriptional profiling by high-throughput RNA sequencing of the aorta displayed a molecular signature for excessive PKC/ERK cell signaling that is the driver of disease. PKC inhibition proved efficacious in multiple pre-clinical models and indeed prevented death due to vascular rupture.
Pivotal Phase 3 studies for both newly-diagnosed diffuse large B-cell lymphoma (DLBCL) and GBM are currently being conducted by Denovo Biopharma LLC, enzastaurin's owner. Enzastaurin received orphan drug designation in DLBCL and glioblastoma multiforme (GBM) from the FDA and EMA. In July 2020, the FDA granted enzastaurin Fast Track qualification for the first-line treatment of GBM. Through this transaction Aytu has secured exclusive global rights to enzastaurin/AR101 from Denovo Biopharma LLC in the fields of rare genetic pediatric onset or congenital disorders outside of oncology. The Company expects to receive Orphan Drug Designation for AR101, allowing for seven years' marketing exclusivity in the United States and ten years in Europe and Japan. AR101 is protected by a suite of pending patents being pursued in major markets globally which have been licensed from The Johns Hopkins University and have an earliest priority date of March 2017.
Conference Call & Webcast (with Slides)
Aytu will host a conference call and webcast this afternoon, Monday, April 12, 2021 at 4:30 p.m. Eastern Time. Josh Disbrow, Chief Executive Officer of Aytu BioPharma, and Dr. Hal Dietz will discuss the Rumpus transaction and the AR101 scientific background, and they will be available to answer questions. Interested participants and investors may access the conference call by dialing (877) 407-9124 (U.S./Canada) or (201) 689-8584 (international). A live webcast presentation can also be accessed via the Investors section of the Aytu BioPharma corporate web site at: https://www.aytubio.com.
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 (see Full Prescribing Information, including Boxed WARNING), Cotempla XR-ODT® (methylphenidate) extended-release orally disintegrating tablets (see Full Prescribing Information, including Boxed WARNING), and Adzenys-ER® (amphetamine) extended-release oral suspension (see Full Prescribing Information, including Boxed WARNING). 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. As Aytu continues this trajectory, the company is building a complimentary therapeutic development pipeline that will address significant unmet needs. For more information, please visit https://aytubio.com.
About Rumpus Therapeutics
Rumpus Therapeutics is a private, specialty biopharmaceutical company dedicated to advancing innovative science for neglected pediatric diseases. Rumpus Therapeutics is focused on drug development for rare and orphan diseases that predominantly have pediatric onset and for which there are no currently approved therapies. For additional information please visit https://www.rumpustx.com.
Forward-Looking Statements
This press release includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, or the Exchange Act. All statements other than statements of historical facts contained in this press release, are forward-looking statements. Forward-looking statements are generally written in the future tense and/or are preceded by words such as ''may,'' ''will,'' ''should,'' ''forecast,'' ''could,'' ''expect,'' ''suggest,'' ''believe,'' ''estimate,'' ''continue,'' ''anticipate,'' ''intend,'' ''plan,'' or similar words, or the negatives of such terms or other variations on such terms or comparable terminology. All statements other than statements of historical facts contained in this presentation, are forward-looking statements, including but not limited to any statements regarding the results and effects of the Rumpus asset purchase, future opportunities for the newly constituted company, future financial performance and condition, guidance and any other statements regarding the newly constituted company's future expectations, beliefs, plans, objectives, financial conditions, assumptions or future events or performance including clinical trial results. These statements are just predictions and are subject to risks and uncertainties that could cause the actual events or results to differ materially. These risks and uncertainties include, among others: potential adverse changes to our business, including those resulting from the completion of the Rumpus transaction, the diversion of management time on transaction-related issues, the ultimate timing, outcome and results of integrating the operations and personnel of Rumpus, the effects of the acquisition of the Rumpus assets, including the combined company's future financial condition with the addition of these assets, results of operations, strategy and plans, changes in capital markets and the ability of the combined company to finance operations in the manner expected, risks relating to gaining market acceptance of our products, obtaining reimbursement by third-party payors, the potential future commercialization of the combined company's product candidates, the anticipated start dates, durations and completion dates, as well as the potential future results, of the combined company's ongoing and future clinical trials, the anticipated designs of the combined company's future clinical trials, anticipated future regulatory submissions and events, the combined company's anticipated future cash position and future events under current and potential future collaboration. We also refer you to (i) the risks described in ''Risk Factors'' in Part I, Item 1A of Aytu's Annual Report on Form 10-K and in the other reports and documents it files with the Securities and Exchange Commission and (ii) the Risk Factors set forth in Aytu's Annual Report on Form 10-K and Quarterly Reports on Form 10-Q filed with the SEC.
Contact for Media and Investors:
Sarah McCabe
Stern Investor Relations, Inc.
mailto://sarah.mccabe@sternir.com
SOURCE: Aytu BioPharma, Inc.
View source version on accesswire.com:
https://www.accesswire.com/639869/Aytu-BioPharma-Adds-Late-Stage-Pediatric-Onset-Rare-Disease-Asset-to-Development-Pipeline-from-Rumpus-Therapeutics
NEWS -- Aytu BioPharma Strengthens Leadership Team with Appointment of Richard Eisenstadt as Chief Financial Officer
ENGLEWOOD, CO / ACCESSWIRE / April 5, 2021 / Aytu BioPharma, Inc. (NASDAQ:AYTU), a specialty pharmaceutical company focused on commercializing novel therapeutics and consumer healthcare products, today announced the appointment of 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.
Mr. Eisenstadt replaces David Green who has stepped down as Chief Financial Officer as of March 31, 2021.
Mr. Eisenstadt most recently was Chief Financial Officer at Neos Therapeutics, Inc. where he raised over $340 million in private and public equity and debt financings and supported the transition of the company from clinical stage to commercial operations prior to its merger with Aytu in March 2021. Prior to Neos, Mr. Eisenstadt served as Chief Financial Officer at Arborgen, Inc., and prior to that, Chief Financial Officer at Tranzyme, Inc., where he led its IPO, negotiated several licensing agreements, and financed the company through late-stage clinical development. Mr. Eisenstadt received an M.B.A. from James Madison University and a B.A. in Economics from the University of North Carolina at Chapel Hill.
"Rich's deep experience with financial planning and accounting, raising capital, investor relations, clinical development, and commercial operations will be a tremendous asset to Aytu, especially as we continue to grow our commercial portfolio of prescription therapeutics and consumer health products and expand our development pipeline. His appointment comes at a pivotal time for the company, and we are very pleased to have him join the team," commented Josh Disbrow, Chief Executive Officer of Aytu BioPharma. "Also, as Dave departs the company, the Board and I wish to express our sincere gratitude to Dave for his many contributions and service to Aytu and wish him well."
Mr. Eisenstadt commented, "I am honored to be asked to join Aytu to support the combination of the Neos and Aytu branded prescription therapeutic portfolios. Together with Josh and the incumbent management team, I look forward to continuing to build value through both organic growth in our product offerings and through strategic acquisitions of late-stage product candidates and on-market assets."
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 (see Full Prescribing Information, including Boxed WARNING), Cotempla XR-ODT® (methylphenidate) extended-release orally disintegrating tablets (see Full Prescribing Information, including Boxed WARNING), and Adzenys-ER® (amphetamine) extended-release oral suspension (see Full Prescribing Information, including Boxed WARNING). 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. As Aytu continues this trajectory, the company is building a complimentary therapeutic development pipeline that will address significant unmet needs. For more information, please visit https://aytubio.com.
Forward-Looking Statements
This press release includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, or the Exchange Act. All statements other than statements of historical facts contained in this press release, are forward-looking statements. Forward-looking statements are generally written in the future tense and/or are preceded by words such as ''may,'' ''will,'' ''should,'' ''forecast,'' ''could,'' ''expect,'' ''suggest,'' ''believe,'' ''estimate,'' ''continue,'' ''anticipate,'' ''intend,'' ''plan,'' or similar words, or the negatives of such terms or other variations on such terms or comparable terminology. All statements other than statements of historical facts contained in this presentation, are forward-looking statements, including but not limited to any statements regarding future growth of the company's product offerings and expansion of its development and commercial pipeline. Please also refer to the risks described in ''Risk Factors'' in Part I, Item 1A of Aytu's Annual Report on Form 10-K and in the other reports and documents it files with the Securities and Exchange Commission.
Contact for Media and Investors:
Sarah McCabe
Stern Investor Relations, Inc.
mailto://sarah.mccabe@sternir.com
SOURCE: Aytu BioPharma, Inc.
View source version on accesswire.com:
https://www.accesswire.com/638696/Aytu-BioPharma-Strengthens-Leadership-Team-with-Appointment-of-Richard-Eisenstadt-as-Chief-Financial-Officer
NEWS -- Aytu BioPharma Divests U.S. Rights to Natesto(R) to Acerus Pharma
Strategic Transaction Provides $7.5M in Non-Dilutive Capital and Enables Pediatric and ADHD Product Focus Following the Recently Closed Merger with Neos Therapeutics
ENGLEWOOD, CO / ACCESSWIRE / April 1, 2021 / Aytu BioPharma, Inc. (NASDAQ:AYTU) a specialty pharmaceutical company focused on commercializing novel therapeutics and consumer healthcare products, today announced the signing of an agreement with Acerus Pharmaceuticals Corporation (ASP)(ASPCF) whereby Acerus will acquire all remaining rights to Natesto in the United States from Aytu. In consideration, Aytu will receive $7.5M in cash from Acerus, which is payable in $250,000 monthly payments over 30 months. Additionally, Acerus will assume all product responsibilities associated with Natesto following the April 1, 2021 effective date. Aytu will provide transition support to Acerus over a 120-day transition period.
"This strategic transaction is an important milestone for Aytu BioPharma as it solidifies our go-forward therapeutic focus on pediatric medicine and plan to become a leading specialty pediatrics company," said Josh Disbrow, Chief Executive Officer of Aytu BioPharma. He further commented, "In conjunction with finalizing and closing the merger with Neos Therapeutics, we conducted a strategic review of our legacy Rx business. Following that review, we believe focusing commercial efforts on our newly expanded portfolio of ADHD and pediatric products provides the best opportunity to increase shareholder value. As such we will deploy our resources and sales force accordingly against pediatricians and ADHD clinicians as the newly formed Aytu BioPharma." Along with receiving $7.5M in cash, Acerus will purchase all on-hand Natesto inventory from Aytu.
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 (see Full Prescribing Information, including Boxed WARNING), Cotempla XR-ODT® (methylphenidate) extended-release orally disintegrating tablets (see Full Prescribing Information, including Boxed WARNING), and Adzenys-ER® (amphetamine) extended-release oral suspension (see Full Prescribing Information, including Boxed WARNING). 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. As Aytu continues this trajectory, the company is building a complimentary therapeutic development pipeline that will address significant unmet needs. For more information, please visit https://aytubio.com.
Forward-Looking Statements
This press release includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, or the Exchange Act. All statements other than statements of historical facts contained in this press release, are forward-looking statements. Forward-looking statements are generally written in the future tense and/or are preceded by words such as ''may,'' ''will,'' ''should,'' ''forecast,'' ''could,'' ''expect,'' ''suggest,'' ''believe,'' ''estimate,'' ''continue,'' ''anticipate,'' ''intend,'' ''plan,'' or similar words, or the negatives of such terms or other variations on such terms or comparable terminology. All statements other than statements of historical facts contained in this presentation, are forward-looking statements, including but not limited to any statements regarding future growth of the company's product offerings and expansion of its development and commercial pipeline. Please also refer to the risks described in ''Risk Factors'' in Part I, Item 1A of Aytu's Annual Report on Form 10-K and in the other reports and documents it files with the Securities and Exchange Commission.
Contact for Media and Investors:
Sarah McCabe
Stern Investor Relations
mailto://sarah.mccabe@sternir.com
SOURCE: Aytu BioPharma, Inc.
View source version on accesswire.com:
https://www.accesswire.com/638540/Aytu-BioPharma-Divests-US-Rights-to-NatestoR-to-Acerus-Pharma
Aytu BioPharma Divests US Rights To Natesto To Acerus Pharma
Aytu BioPharma, Inc. (NASDAQ:AYTU) a specialty pharmaceutical company focused on commercializing novel therapeutics and consumer healthcare products, today announced the signing of an agreement with Acerus Pharmaceuticals Corporation (ASP)(ASPCF) whereby Acerus will acquire all remaining rights to Natesto in the United States from Aytu. In consideration, Aytu will receive $7.5M in cash from Acerus, which is payable in $250,000 monthly payments over 30 months. Additionally, Acerus will assume all product responsibilities associated with Natesto following the April 1, 2021 effective date. Aytu will provide transition support to Acerus over a 120-day transition period.
Current Report Filing (8-k)
https://ih.advfn.com/stock-market/NASDAQ/aytu...
1 hour ago · Item 8.01 – Other Events. On March 20, 2021, Aytu BioPharma, Inc. (the “Company”) issued 102,759 shares of the Company’s common stock valued at $1.0 million to the holders of the Contingent Value Rights (“CVR”) relating to the February 14, 2020 merger with Innovus Pharmaceuticals, Inc. (“Innovus”), as a result of the Consumer Business Unit achieving one of two components of ..
Then you'd better be out within 2-3 years. I don't see this company being profitable.
I'm just hoping there's no more reverse splits. One more reverse split and I'm out
To bad they played games to get the share price up so the merger would go through. Smart people bailed when got above 10. Even smarter people shorted when 10 or above. Now comes the money burn
And they will still lose big piles of money and sell more shares to keep this operation running...
NEWS -- Aytu BioScience Announces Close of Merger with Neos Therapeutics
Finally we have a nice uptrend here. Soon we will trade in the double digits.
This company could turn farts into gold and it would still trade red
NEWS -- Aytu BioScience Announces Positive Clinical Results from Healight(TM) Pilot Study in SARS-CoV-2 Patients
Data indicate endotracheal UVA light catheter therapy reduces SARS-CoV-2 viral load and improves clinical outcomes in mechanically ventilated SARS-CoV-2 patients
ENGLEWOOD, CO / ACCESSWIRE / March 8, 2021 / Aytu BioScience, Inc. (NASDAQ:AYTU), a specialty pharmaceutical company focused on commercializing novel products that address significant patient needs, announced today 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%, p=0.0018) and -3.2 (>99.9%, p=0.0005), 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:
https://www.medrxiv.org/content/10.1101/2021.03.05.21252997v1.article-metrics
About Aytu BioScience, Inc.
Aytu BioScience is a commercial-stage specialty pharmaceutical company focused on commercializing novel products that address significant patient needs. Aytu currently markets a portfolio of prescription products addressing large primary care and pediatric markets. The portfolio includes Natesto®, the only FDA-approved nasal formulation of testosterone for men with hypogonadism (low testosterone, or "Low T"), ZolpiMist®, the only FDA-approved oral spray prescription sleep aid, Tuzistra® XR, the only FDA-approved 12-hour codeine-based antitussive syrup, Karbinal® ER, an extended-release carbinoxamine (antihistamine) suspension indicated to treat numerous allergic conditions, and Poly-Vi-Flor® and Tri-Vi-Flor®, two complementary prescription fluoride-based supplement product lines containing combinations of fluoride and vitamins in various formulations for infants and children with fluoride deficiency. Aytu also distributes a COVID-19 IgG/IgM rapid antibody test and a rapid COVID-19 antigen test. These tests are used separately in the rapid, qualitative diagnostic assessment of the 2019 Novel Coronavirus. Additionally, Aytu has licensed worldwide rights to develop the Healight™ technology platform. Healight is an investigational medical device being studied as a prospective treatment for COVID-19 and other respiratory infections.
Aytu operates a consumer health subsidiary, Aytu Consumer Health that licenses and develops safe and effective consumer healthcare products designed to improve men's and women's health and vitality. Aytu Consumer Health commercializes numerous novel consumer health products competing in large healthcare categories including diabetes, men's health, sexual wellness, respiratory health, and general wellness. The Aytu Consumer Health product portfolio is commercialized through direct-to-consumer marketing channels utilizing the company's proprietary Beyond Human® marketing and sales platform.
Aytu's strategy is to continue building its portfolio of revenue-generating Rx and consumer health products, leveraging its focused commercial team and expertise to build leading brands within large therapeutic markets. For more information visit http://aytubio.com.
Forward-Looking Statements
This press release includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, or the Exchange Act. All statements other than statements of historical facts contained in this press release, are forward-looking statements. Forward-looking statements are generally written in the future tense and/or are preceded by words such as ''may,'' ''will,'' ''should,'' ''forecast,'' ''could,'' ''expect,'' ''suggest,'' ''believe,'' ''estimate,'' ''continue,'' ''anticipate,'' ''intend,'' ''plan,'' or similar words, or the negatives of such terms or other variations on such terms or comparable terminology. All statements other than statements of historical facts contained in this presentation, are forward-looking statements, including but not limited to any statements regarding the results of the Healight clinical studies, the effectiveness of Healight in treating SARS-CoV-2, the effectiveness of Healight as compared to other treatments of SARS-CoV-2, the safety of Healight as compared to other treatments of SARS-CoV-2, the outcomes of discussions relating to Healight with regulators including the Food & Drug Administration (FDA), the commercial plans involving Healight, and other forward-looking aspects related to the Healight program. These statements are just predictions and are subject to risks and uncertainties that could cause the actual events or results to differ materially. These risks and uncertainties include, among others: our future financial results, the results of the Healight clinical program and outcomes of regulatory discussions, failure to obtain the required votes of Neos' shareholders or Aytu's shareholders to approve the recently announced Neos merger transaction and related matters, the risk that a condition to closing of the proposed transaction may not be satisfied, that either party may terminate the merger agreement or that the closing of the proposed transaction might be delayed or not occur at all, potential adverse reactions or changes to business or employee relationships, including those resulting from the announcement or completion of the transaction, the diversion of management time on transaction-related issues, the ultimate timing, outcome and results of integrating the operations of Aytu and Neos, the effects of the business combination of Aytu and Neos, including the combined company's future financial condition, results of operations, strategy and plans, the ability of the combined company to realize anticipated synergies in the timeframe expected or at all, changes in capital markets and the ability of the combined company to finance operations in the manner expected, regulatory approval of the transaction, risks relating to gaining market acceptance of our products, obtaining reimbursement by third-party payors, the potential future commercialization of the combined company's product candidates, the anticipated start dates, durations and completion dates, as well as the potential future results, of the combined company's ongoing and future clinical trials, the anticipated designs of the combined company's future clinical trials, anticipated future regulatory submissions and events, the combined company's anticipated future cash position and future events under current and potential future collaboration, the regulatory and commercial risks associated with the Company's distributed COVID-19 rapid tests, the accuracy of the COVID-19 rapid tests as compared to other COVID-19 tests, market acceptance of the tests, the ability to obtain FDA approval or authorization for the tests, our ability to obtain sufficient tests to meet consumer demand, if any, the manufacturers' ability to meet customer demand, if any, reputation risks if the tests are not as effective as anticipated, and that the current regulatory environment continues to permit the sale of the tests.
Contact for Media and Investors:
Sarah McCabe
Stern Investor Relations
mailto://sarah.mccabe@sternir.com
SOURCE: Aytu BioScience, Inc.
View source version on accesswire.com:
https://www.accesswire.com/634168/Aytu-BioScience-Announces-Positive-Clinical-Results-from-HealightTM-Pilot-Study-in-SARS-CoV-2-Patients
$aytu $7.3501 ? 0.0001 (0.00%)
Volume: 523,793 @03/05/21 7:59:30 PM EST
NEWS -- Aytu BioScience to Present at Upcoming March Investor Conferences
ENGLEWOOD, CO / ACCESSWIRE / February 24, 2021 / Aytu BioScience, Inc. (NASDAQ:AYTU), a specialty pharmaceutical company focused on commercializing novel products that address significant patient needs, today announced that Josh Disbrow, Chairman and Chief Executive Officer will present at three upcoming investor conferences in March:
$aytu $8.5 v -0.24 (-2.75%)
Volume: 542,770 @02/12/21 7:25:19 PM EST
Bid Ask Day's Range
8.55 8.56 8.15 - 8.62
So revs are up, yoy increase, still not profitable and no headlight mention and people cry and dump. Sounds about right same shit every q.
NEWS -- Aytu BioScience and Neos Therapeutics Announce Special Meetings of Stockholders Related to Proposed Merger to Be Held on March 18, 2021
now trading above the RS price of $8.80
NEWS -- Aytu BioScience to Report Second Fiscal 2021 Results and Provide Business Update on Thursday, February 11, 2021
Looks like there was a reduction of short positions a few weeks ago anyway.
The question is, "Do they know something"?
Shares Short (Jan 15, 2021) 455.95k
Short Ratio (Jan 15, 2021) 0.59
Short % of Float (Jan 15, 2021) 2.68%
Short % of Shares Outstanding (Jan 15, 2021) 2.64%
Shares Short (prior month Dec 15, 2020) 801.77k
https://finance.yahoo.com/quote/AYTU/key-statistics?p=AYTU
Squeeze has to be orchestratedike games top was. The stockholders of AYTU either aren't interested or sophisticated enough to pu a squeeze off
With all of the news about the hedge fund shorting, and the stock is going up even with a 28% short position, I wonder if the "little guys" are putting up a fight to force the shorts out.
Just an interesting thought. For me anyway, the lower the share price goes down the more shares I buy. I'm truly averaging down thanks to the shorts.
Still a significant amount of short interest:
https://fintel.io/ss/us/aytu
In my previous post Healight: The Moonshot Not Yet Heard Round the World
This is one of the potential aspects Healight could be used for:
“We see broad potential application well beyond Healight’s use in COVID,” Mr. Disbrow said when speaking to investors last week, “including ventilator associated pneumonia, severe influenza and other infections.”
Also many places around the globe do not have decent ICUs nor necessarily enough qualified physicians or drugs available. If Healight could could be used early on it could save a lot of lives. "It's just a small catheter that can be inserted down the throat of an intubated, critically ill coronavirus patient." (Same article).
Well I sure wish they wouldn't have wasted all that money researching this idea at Cedars-Sinai. Heck they should have just read the post here at iHub and saved millions.
Someone call Josh and give him this hot tip,,,
The light will only work if caught early enough. Once you're in respiratory distress, it's possible the bacteria has started to enter the blood stream (from what I understand). The bacteria normally starts in the nasal passage and works it's way down. I'm also assuming yours peaking of pneumococcus bacteria.
We're talking about the ventilator associated pneumonia that kills hundreds of thousands of people a year.....They die because they can't breath not because some of the bacteria may be in the rest of the body.
If they can kill what's in the lungs, that's what counts.
The shorts are having their turn. If you want to win over the shorter, request your certs.
First of all Dishow's comments are mere huff and puff at this time. Your link refers to mostly microbial infections which are throughout the body. UV light will only work on surface or exposed microbes. As time goes on they will become more resistant through mutation. It will take a lot more evidence for widespread approval. AYTU doesn't have that kind of money.
Healight has an enormous potential.
"Mr. Disbrow stated. “With such a broad set of potential clinical applications, we envision Healight, if successful, to become an important tool in hospital ICUs around the world. Antimicrobial resistance is a global problem and attacking it in a nontraditional way may prove to be a better way to treat difficult infections and rely less on traditional antibiotic and antiviral therapy.”
Antimicrobial resistance: a global multifaceted phenomenon
"The US Center for Disease Control and Prevention (CDC) conservatively estimated that, in the US, more than two million people every year are affected with antibiotic-resistant infections, with at least 23?000 dying as a result of the infection.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4768623/
Healight: The Moonshot Not Yet Heard Round the World
https://swich.medium.com/healight-the-moonshot-not-yet-heard-round-the-world-6d93d5fafece
$aytu $8.35 ^ 0.32 (3.99%)
Volume: 696,585 @01/25/21 5:09:47 PM EST
$aytu $8.05 ^ 0.13 (1.64%)
Volume: 323,425 @01/22/21 7:52:08 PM EST
Great uptrend this year. Healight is coming, soon we trade above $100,00.
Common Viral Respiratory Infections
https://accessmedicine.mhmedical.com/content.aspx?bookid=2683§ionid=225054979#1175820964
ATYU's Healight has a HUGE potential worldwide.
Obviously shorting a stock can only make you money if it goes down. I personally doubt if AYTU will go significantly lower. It'll certainly have small dip days, but only enough to earn beer money.There's too much synergy from their potential merger that'll lower costs as revenue rises.
So the stock was $6 a share for a good while... How are those that shorted at $6 doing now?
Followers
|
237
|
Posters
|
|
Posts (Today)
|
0
|
Posts (Total)
|
18805
|
Created
|
04/30/13
|
Type
|
Free
|
Moderators |
Aytu BioScience is pursuing an emergency use authorization with the FDA for the COVID-19 IgG/IgM test. The COVID-19 IgG/IgM is a rapid test intended for the presumptive qualitative detection of IgG/IgM antibodies from the 2019-nCoV in blood samples from individuals with signs and symptoms of infection who are suspected of Sars Cov-2.
Healthcare professionals, institutions, and other interested parties with questions about the Company’s recently licensed COVID-19 IgG/IgM Rapid Test are asked to send email inquiries to COVID-19@aytubio.com
_________________________________________________________________________________________________________________________________________________________________________
Volume | |
Day Range: | |
Bid Price | |
Ask Price | |
Last Trade Time: |