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News is spreading just saw story on NBC 9 News Colorado
Funny that pi’s can get two tests done and the public can’t even get one unless there dying then it’s to late. Imo
I agree! Governor will talk about this tomorrow
Aytu in Fox News channel 2 Colorado
Will try to find link. Shows Aytu loading tests into Denver police van.
Ok kids pay attention Crayons is here to teach us about charts. Pay attention to when the line go’s up and when it go’s down! There will be a test in the AM! Lol imo
Bodysphere
Today CNN reported that they don’t!
Bioscience falsely claimed they had FDA approval. CNN reported they do not have approval. Bioscience phone lines are down as per there web page. Things that make you go Mmm
They where just on CNN they have no FDA approval!
It’s the Wild West out there highest bidder wins
Lol right going to miss the train!
Nice!
Go figure I buy more and the stock drops
CNN news testing labs have a 160,000. Test backlogged waiting for results
Here we go again. Up ah and pm then down during trading hrs. So tired of this channel
Not so much today
Can’t believe we are still trading in this channel
Never seen so much manipulation of a stock
Get tested if positive you get to wear a mask till you test negative!
Current Report Filing (8-k)
Source: Edgar (US Regulatory)
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): March 31, 2020
AYTU BIOSCIENCE, INC.
(Exact name of registrant as specified in its charter)
Delaware
001-38247
47-0883144
(State or other jurisdictionof incorporation)
(Commission File Number)
(IRS Employer Identification No.)
373 Inverness Parkway, Suite 206
Englewood, CO 80112
(Address of principal executive offices, including Zip Code)
Registrant’s telephone number, including area code: (720) 437-6580
N/A
(Former name or former address, if changed since last report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
? Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
? Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
? Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
? Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Securities registered pursuant to Section 12(b) of the Act:
Title of each class
Trading Symbol(s)
Name of each exchange on which registered
Common Stock, par value $0.0001 per share
AYTU
The NASDAQ Stock Market LLC
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company ?
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ?
Item 8.01 Other Events
On April 1, 2020, Aytu BioScience, Inc. (the “Company”) a specialty pharmaceutical company focused on commercializing novel products that address significant patient needs announced today that it has received its first Coronavirus Disease 2019 (“COVID-2019”) IgG/IgM Rapid Test shipment containing 100,000 tests from the manufacturer on March 31, 2020. The Company is now in the process of relabeling the test kits to comply with Food and Drug Administration (FDA) requirements relating to labeling of COVID-19 serology test kits and expects to begin filling current backorders and additional incoming orders shortly thereafter.
Additionally, the Company announced that it expects to receive another 500,000 rapid tests from the manufacturer in the next two to three weeks in order to fulfill additional customer orders.
Forward-Looking Statement
This current report on Form 8-K 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 presentation, 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. 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: market and other conditions, the regulatory and commercial risks associated with introducing the COVID-19 IgG/IgM Rapid Test, shipping delays and their impact on our ability to introduce the COVID-19 IgG/IgM Rapid Test, our ability to enforce our exclusive rights to distribute the COVID-19 IgG/IgM Rapid Test in the jurisdictions set forth in the distribution agreement, the ability of the COVID-19 IgG/IgM Rapid Test to accurately and reliably test for COVID-19, the manufacture of the COVID-19 IgG/IgM Rapid Test’s ability to manufacture such testing kits on a high volume scale, manufacturing problems or delays related to the COVID-19 IgG/IgM Rapid Test, our ability to satisfy any labelling conditions or other FDA or other regulatory conditions to sell the COVID-19 IgG/IgM Rapid Test Kit, the ability to obtain a sufficient number of COVID-19 IgG/IgM Rapid Test kits to meet demand if any, the demand or lack thereof for the COVID-19 IgG/IgM Rapid Test Kit, effects of the business combination of Aytu and the Commercial Portfolio and the recently completed merger ("Merger") with Innovus Pharmaceuticals, 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 operationsin the manner expected, the diversion of management time on Merger-related issues and integration of the Commercial Portfolio, the ultimate timing, outcome and results of integrating the operations the Commercial Portfolio and Innovus with Aytu's existingoperations, risks relating to gaining market acceptance of our products, obtaining or maintaining reimbursement by third-party payors for our prescription products, the potential future commercialization of our product candidates, the anticipated start dates, durations and completion dates, as well as the potential future results, of our ongoing and future clinical trials, the anticipated designs of our future clinical trials, anticipated future regulatory submissions and events, our anticipated future cash position and future events under our current and potential future collaboration. We also refer you to the risks described in ''Risk Factors'' in Part I, Item 1A of the company's Annual Report on Form 10-K and in the other reports and documents we file with the Securities and Exchange Commission from time to time.
Item 9.01 Financial Statements and Exhibits.
(d) The following exhibit is being filed herewith:
Exhibit
Description
99.1
Press release announcement dated April 1, 2020
1
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
AYTU BIOSCIENCE, INC.
Date: April 1, 2020
By:
/s/ Joshua R. Disbrow
Joshua R. Disbrow
Chief Executive Officer
2
There here!
NEWS
Aytu BioScience Announces Receipt of Initial Shipment of 100,000 COVID-19 IgG/IgM Point-of-Care Rapid Tests; Additional 500,000 Tests on Order
Initial Shipment of 2-10 Minute COVID-19 Rapid Tests Received at Company's Englewood, Colorado Facility
ENGLEWOOD, CO / ACCESSWIRE / April 1, 2020 / Aytu BioScience, Inc. (NASDAQ:AYTU),(the "Company"), a specialty pharmaceutical company focused on commercializing novel products that address significant patient needs announced today that it has received its first Coronavirus Disease 2019 ("COVID-2019") IgG/IgM Rapid Test shipment containing 100,000 tests from the manufacturer. The Company is now in the process of relabeling the test kits to comply with Food and Drug Administration (FDA) requirements relating to labeling of COVID-19 serology test kits and expects to begin filling current backorders and additional incoming orders shortly thereafter.
Additionally, the Company expects to receive another 500,000 rapid tests from the manufacturer in the next two to three weeks in order to fulfill additional customer orders.
Josh Disbrow, Chief Executive Officer of Aytu BioScience, commented, "We're pleased to have the first 100,000 tests now in stock at our facility in Englewood, Colorado. The Company is now preparing the kits for shipment to customers. Following the completion of the labeling process and final clearance by FDA, we'll be shipping this initial inventory to healthcare professionals across the country. While preparing these kits for distribution, we are also preparing to receive our next shipment of 500,000 tests."
The COVID-19 IgG/IgM Rapid Test is a solid phase immunochromatographic assay used in the rapid, qualitative and differential detection of IgG and IgM antibodies to the 2019 Novel Coronavirus in human whole blood, serum or plasma. This point-of-care test has been validated in a 126 patient clinical trial and is CE marked. The COVID-19 IgG/IgM Rapid Test is registered with the FDA and listed on the FDA website as one of the serology tests allowed by the agency to be commercialized in the United States. The COVID-19 IgG/IgM Rapid Test is intended for professional use and delivers results between 2 and 10 minutes at the point-of-care.
About Aytu BioScience, Inc.
Aytu BioScience is a commercial-stage specialty pharmaceutical company focused on commercializing novel products that address significant patient needs. The Company currently markets a portfolio of prescription products addressing large primary care and pediatric markets. The primary care portfolio includes (i) Natesto®, the only FDA-approved nasal formulation of testosterone for men with hypogonadism (low testosterone, or "Low T"), (ii) ZolpiMist™, the only FDA-approved oral spray prescription sleep aid, and (iii) Tuzistra® XR, the only FDA-approved 12-hour codeine-based antitussive syrup. The pediatric portfolio includes (i) AcipHex® Sprinkle™, a granule formulation of rabeprazole sodium, a commonly prescribed proton pump inhibitor; (ii) Cefaclor, a second-generation cephalosporin antibiotic suspension; (iii) Karbinal® ER, an extended-release carbinoxamine (antihistamine) suspension indicated to treat numerous allergic conditions; and (iv) Poly-Vi-Flor® and Tri-Vi-Flor®, two complementary prescription fluoride-based supplement product lines containing combinations of fluoride and vitamins in various for infants and children with fluoride deficiency. Aytu recently acquired exclusive U.S. distribution rights to the COVID-19 IgG/IgM Rapid Test. This coronavirus test is a solid phase immunochromatographic assay used in the rapid, qualitative and differential detection of IgG and IgM antibodies to the 2019 Novel Coronavirus in human whole blood, serum or plasma. This point-of-care test has been validated in a 113 patient clinical trial and has received CE marking.
Aytu recently acquired Innovus Pharmaceuticals, a specialty pharmaceutical company commercializing, licensing and developing safe and effective consumer healthcare products designed to improve men's and women's health and vitality. Innovus commercializes over thirty-five consumer health products competing in large healthcare categories including diabetes, men's health, sexual wellness and respiratory health. The Innovus 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 products, leveraging its focused commercial team and expertise to build leading brands within large therapeutic markets. For more information visit aytubio.com and visit innovuspharma.com to learn about the Company's consumer healthcare products.
The lack of testing is killing Americans.
Where is the 25 million test that was promised by the United States Government by the end of March!
It’s great that there getting test but where does it say there Aytu kits?
Want to hear from the Company
Looks like everyone is getting out
Oh well we will see got to go to work
Hope there just shaking this in pre market and it climbs during the day
Every State is asking for rapid testing and still no news from this outfit and price keeps dropping.
Lol seems no matter what information gets put out there this stock just won’t move
Morgan Stanley is an institutional holder in this stock
Institutional Ownership and Shareholders
AYTU / Aytu BioScience, Inc. Institutional Ownership
Aytu BioScience, Inc. (NASDAQ:AYTU) has 29 institutional investors and shareholders that have filed 13D/G or 13F forms with the Securities Exchange Commission (SEC). These institutions hold a total of 8,463,194 shares. Largest shareholders include Armistice Capital, Llc, Searle & Co., VEXMX - Vanguard Extended Market Index Fund Investor Shares, Vanguard Group Inc, Geode Capital Management, Llc, FSMAX - Fidelity Extended Market Index Fund, Morgan Stanley, BlackRock Inc., IWC - iShares Micro-Cap ETF, and Northern Trust Corp.
Aytu BioScience, Inc. (NASDAQ:AYTU) ownership structure shows current positions in the company by institutions and funds, as well as latest changes in position size. Major shareholders can include individual investors, mutual funds, hedge funds, or institutions. The Schedule 13D indicates that the investor holds (or held) more than 5% of the company and intends (or intended) to actively pursue a change in business strategy. Schedule 13G indicates a passive investment of over 5%.
Good surmise. I am a Project Manager for a GC company. You have to know how to play the game, and have a good working relationship with all your Inspetor’s to make your project run smoothly. Your fist inspection with a new inspector is all ways the rough one fix any listed discrepancies reinspect and it gets easier from then on if you follow the rules
Company needs to say something to reassure the investors of this company. The silence by the company not fairing well with many.
Additional Proxy Soliciting Materials (definitive) (defa14a)
Source: Edgar (US Regulatory)
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, DC 20549
SCHEDULE 14A
(RULE 14a-101)
SCHEDULE 14A INFORMATION
Proxy Statement Pursuant to Section 14(A) of the
Securities Exchange Act of 1934
Filed by the Registrant ?
Filed by a Party other than the Registrant ?
Check the appropriate box:
? Preliminary Proxy Statement
? Confidential, for Use of the Commission Only (as permitted by Rule 14a-6(e)(2))
? Definitive Proxy Statement
? Definitive Additional Materials
? Soliciting Material Pursuant to § 240.14a-12
Aytu BioScience, Inc.
(Name of Registrant as Specified In Its Charter)
(Name of Person(s) Filing Proxy Statement if other Than the Registrant)
Payment of Filing Fee (Check the appropriate box):
? No fee required.
? Fee computed on table below per Exchange Act Rules 14a-6(i)(1) and 0-11.
(1) Title of each class of securities to which transaction applies:
(2) Aggregate number of securities to which transaction applies:
(3) Per unit price or other underlying value of transaction computed pursuant to Exchange Act Rule 0-11 (set forth the amount on which the filing fee is calculated and state how it was determined):
(4) Proposed maximum aggregate value of transaction:
(5) Total fee paid:
? Fee paid previously with preliminary materials.
? Check box if any part of the fee is offset as provided by Exchange Act Rule 0-11(a)(2) and identify the filing for which the offsetting fee was paid previously. Identify the previous filing by registration statement number, or the Form or Schedule and the date of its filing.
(1) Amount Previously Paid:
(2) Form, Schedule or Registration Statement No.:
(3) Filing Party:
(4) Date Filed:
AYTU BIOSCIENCE, INC.
373 Inverness Parkway, Suite 206
Englewood, Colorado 80112
NOTICE OF ANNUAL MEETING OF STOCKHOLDERS
TO BE HELD MARCH 31, 2020
To the Stockholders of Aytu BioScience, Inc.:
Aytu BioScience, Inc. (the “Company”) a specialty pharmaceutical company focused on commercializing novel products that address significant patient needs, announced today that its annual meeting of stockholders originally scheduled to be held on March 31, 2020 at 10:00 a.m. MST will be delayed to a later date to be determined by its Board of Directors (the “Annual Meeting”). The Company hopes to have the Annual Meeting by April 25, 2020 so that the record date for determining shareholders entitled to vote will remain unchanged. The Annual Meeting is being delayed due to the public health impact of the coronavirus pandemic (COVID-19) and the “shelter in place” order from the Governor of the State of Colorado. This change has been made out of an abundance of caution and is intended to support the health and well-being of the Company’s stockholders, employees and the Colorado community. The Company is assessing all options including the possibility of holding a virtual or hybrid meeting with a view to protect the health and safety of the Company’s employees, stockholders and others who usually attend the annual meeting.
There going to delete this
Short bus is here spreading false information again. Check Aytu web site for new FDA approved insert for packages
We are golden here.
And it was in Chinese not English
Need this sticked
Awesome news thanks for this