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AYTU ISNT ON THIS LETTER. SUB DEALERS ARE PLAIN ENGLISH. DUH
Subs dealers???
Looks like there are more exclusive rights owners. Obviously
No PR’s
AYTU Website updated- no updates.
Why cancel investors conference scared to answer questions??? http://filings.irdirect.net/data/1385818/000121390020007828/ea120160-defa14a_ayutbio.pdf
No proof of sales/contracts/AIA/P.O.
Updates are from other sources not AYTU.
Net loss. https://irdirect.net/AYTU/financials
Risks Related to our Operations
We are relying on FDA policies and guidance provisions that have changed very recently and relate directly to the 2019 coronavirus health crisis. If we misinterpret this guidance or the guidance changes unexpectedly and/or materially, potential sales of the COVID-19 test would be impacted.
The U.S. Food and Drug Administration (FDA) issued non-binding guidance for manufacturers relating to the pathway to enable FDA approval for devices related to testing for COVID-19 under an Emergency Use Authorization (EUA). Following the issuance of the initial published guidance, on March 16, 2020, revised guidance specific to COVID-19 ‘antibody tests’ was issued. In this guidance document and in subsequent communications with FDA officials, the pathway to enable distribution of the COVID-19 test was further explained. If our interpretation of the newly revised guidance is incorrect or specifics around the guidance change, the sales of the COVID-19 test could be materially impacted.
If our recently licensed COVID-19 IgG/IgM Rapid Test does not perform as expected or the reliability of the technology is questioned, we could experience delayed or reduced market acceptance of the test, increased costs and damage to our reputation.
Our success depends on the market’s confidence that we can provide a reliable, high-quality COVID-19 diagnostic test. We believe that customers in our target markets are likely to be particularly sensitive to product defects and errors. Our reputation and the public image of our licensed COVID-19 diagnostic test may be impaired if it fails to perform as expected or is perceived as difficult to use. Despite quality control testing, defects or errors could occur with the test.
In the future, if our licensed COVID-19 diagnostic test experiences a material defect or error, this could result in loss or delay of revenues, delayed market acceptance, damaged reputation, diversion of development resources, legal claims, increased insurance costs or increased service and warranty costs, any of which could harm our business. Such defects or errors could also prompt us to amend certain warning labels or narrow the scope of the use of our diagnostic tests, either of which could hinder our success in the market. Even after any underlying concerns or problems are resolved, any widespread concerns regarding our technology or any manufacturing defects or performance errors in the test could result in lost revenue, delayed market acceptance, damaged reputation, increased service and warranty costs and claims against us.
If we become subject to claims relating to improper handling, storage or disposal of hazardous materials, we could incur significant cost and time to comply.
Our research and development processes involve the controlled storage, use and disposal of hazardous materials, including biological hazardous materials. We are subject to foreign, federal, state and local regulations governing the use, manufacture, storage, handling and disposal of materials and waste products. We may incur significant costs complying with both existing and future environmental laws and regulations. In particular, we are subject to regulation by the Occupational Safety and Health Administration, or OSHA, and the Environmental Protection Agency, or EPA, and to regulation under the Toxic Substances Control Act and the Resource Conservation and Recovery Act in the United States. OSHA or the EPA may adopt additional regulations in the future that may affect our research and development programs. The risk of accidental contamination or injury from hazardous materials cannot be eliminated completely. In the event of an accident, we could be held liable for any damages that result, and any liability could exceed the limits or fall outside the coverage of our workers’ compensation insurance. We may not be able to maintain insurance on acceptable terms, if at all.
S-7
Our licensed COVID-19 test has not been manufactured on a high-volume scale and could be subject to unforeseen scale-up risks.
While the manufacturer of the COVID-19 IgG/IgM Rapid Test has experience manufacturing diagnostic tests, there can be no assurance that they can manufacture the COVID-19 diagnostic test at a scale that is adequate for our current and future commercial needs. We may face significant or unforeseen difficulties in securing adequate supply of the COVID-19 diagnostic test, relating to the manufacturing of the test. These risks include but are not limited to:
• Technical issues relating to manufacturing components of the COVID-19 diagnostic test on a high-volume commercial scale at reasonable cost, and in a reasonable time frame;
• difficulty meeting demand or timing requirements for orders due to excessive costs or lack of capacity for part or all of an operation or process;
• changes in government regulations or in quality or other requirements that lead to additional manufacturing costs or an inability to supply product in a timely manner, if at all; and
• increases in raw material or component supply cost or an inability to obtain supplies of certain critical supplies needed to complete our manufacturing processes.
These and other difficulties may only become apparent when scaling up to the manufacturing process of the COVID-19 diagnostic test to a more substantive commercial scale. In the event the test cannot be manufactured in sufficient commercial quantities or manufacturing is delayed, our future prospects could be significantly impacted and our financial prospects could be materially harmed.
Our suppliers may experience development or manufacturing problems or delays that could limit the growth of our revenue or increase our losses.
We may encounter unforeseen situations in the manufacturing of the COVID-19 diagnostic test that could result in delays or shortfalls in our production. Suppliers may also face similar delays or shortfalls. In addition, suppliers’ production processes may have to change to accommodate any significant future expansion of manufacturing capacity, which may increase suppliers’ manufacturing costs, delay production of diagnostic tests, reduce our product gross margin and adversely impact our business. If we are unable to keep up with demand for the COVID-19 diagnostic test by successfully securing supply and shipping our diagnostic tests in a timely manner, our revenue could be impaired, market acceptance for the test could be adversely affected and our customers might instead purchase our competitors’ diagnostic tests.
We have relied and expect to continue to rely on third parties to conduct studies of the COVID-19 diagnostic test that will be required by the FDA or other regulatory authorities and those third parties may not perform satisfactorily.
Although we intend to sell the COVID-19 IgG/IgM Rapid Test by virtue of recent FDA guidance allowing for reduced product clinical and analytical studies, we have relied on third parties, such as independent testing laboratories and hospitals, to conduct such studies. Our reliance on these third parties will reduce our control over these activities. These third-party contractors may not complete activities on schedule or conduct studies in accordance with regulatory requirements or our study design. We cannot control whether they devote sufficient time, skill and resources to our studies. Our reliance on third parties that we do not control will not relieve us of any applicable requirement to prepare, and ensure compliance with, various procedures required under good clinical practices. If these third parties do not successfully carry out their contractual duties or regulatory obligations or meet expected deadlines, if the third parties need to be replaced or if the quality or accuracy of the data they obtain is compromised due to their failure to adhere to our clinical protocols or regulatory requirements or for other reasons, our studies may be extended, delayed, suspended or terminated, and we may not be able to obtain regulatory approval for additional diagnostic tests.
If the manufacturer’s delivery of the COVID-19 tests and the required clinical data is delayed, then our ability to obtain necessary regulatory approvals and/or authorizations to the distribute the COVID-19 test will be impaired, which will adversely affect our business plans.
While the FDA has provided a path forward to begin selling the COVID-19 tests on an expedited basis, we are still required to provide the FDA with data concerning the validation of the tests and to satisfy certain labelling conditions. If the manufacturer is delayed in delivering to us the COVID-19 tests and related validation data, we will, in turn, be delayed in obtaining FDA approval and/or distribution authorization required before we can begin selling the COVID-19 tests. Any such delays will adversely affect our business plans.
S-8
We rely on a third party to manufacture the COVID-19 test for us and if such third party refuses or is unable to supply us with the COVID-19 test, our business will be materially harmed.
We rely on a third party to manufacture the COVID-19 diagnostic test, which manufacturer licenses its rights from the owner of the intellectual property underlying the COVID-19 test. If any issues arise with respect to the manufacturer’s ability to manufacture and deliver to us the COVID-19 tests, our business could be materially harmed.
While we have obtained an exclusive distribution agreement for the right to commercialize the COVID-19 test in the United States, Canada and Mexico, the manufacturer has no obligation to supply us with a minimum amount of, or any, COVID-19 tests. The manufacturer may choose not to supply us with a sufficient quantity of such tests in order to supply such tests to other distributors, or for any reason. In addition, the manufacturer may be unable to provide us with an adequate supply of COVID-19 tests for various reasons, including, among others, if it becomes insolvent, if a United States regulatory authority or other governments block the import or sale of the COVID-19 tests, if it fails to maintain its rights to manufacture the COVID-19 test, or if the owner of the underlying intellectual property fails to adequately maintain such intellectual property.
If there is little or no demand for the COVID-19 test our business could be materially harmed.
While we have received a number of inquiries regarding the COVID-19 test and expect to receive orders upon our receipt of a supply of COVID-19 tests, there is no guarantee that such inquiries will result in customer orders. If no orders for the COVID-19 test are made, our business will be materially harmed.
The recent coronavirus (COVID-19) outbreak could adversely affect our financial condition and results of operation.
In December 2019, a novel strain of coronavirus (COVID-19) was reported to have surfaced in Wuhan, China. The impact of the outbreak of COVID-19 on the businesses and the economy in China and the rest of the world is unknown. If the impact is significant, the outbreak could impact our ability to implement logistic centers, develop business, conduct operations, and obtain components used in our products. The extent to which COVID-19 outbreak will impact business and the economy is highly uncertain and cannot be predicted. Accordingly, we cannot predict the extent to which our financial condition and results of operation will be affected.
No proof of exclusive rights? Other companies selling test kits.
Only registered with FDA to repack/relabel
READ RISK FACTORS
http://filings.irdirect.net/data/1385818/000121390020007010/ea119790-424b5_aytu.pdf#page2
DILUTIONS
Risks Related to this Offering
Purchasers of common shares in this offering will experience immediate and substantial dilution in the book value of their investment.
The offering price per share of common stock in this offering is substantially higher than the net tangible book value per share of our common shares before giving effect to this offering. Accordingly, if you purchase common stock in this offering, you will incur immediate substantial dilution of approximately $0.499 per common share, representing the difference between the offering price per share of common stock, and our as adjusted net tangible book value as of December 31, 2019 (after giving effect to the proceeds of the issuance of shares of common stock and the exercise of a certain number of warrants issued in connection with the First RD Offering and the Second RD Offering as if those actions had occurred as of December 31, 2019). Furthermore, if outstanding options or warrants are exercised, you could experience further dilution. For a further description of the dilution that you will experience immediately after this offering, see the section in this prospectus supplement entitled “Dilution.”
A substantial number of common shares may be sold in the market following this offering, which may depress the market price for our common shares.
Sales of a substantial number of common shares in the public market following this offering could cause the market price of our common shares to decline. A substantial majority of the outstanding common shares are, and the common shares offered hereby will be, freely tradable without restriction or further registration under the Securities Act.
You may experience future dilution as a result of future equity offerings and other issuances of our common shares or other securities. In addition, this offering and future equity offerings and other issuances of our common shares or other securities may adversely affect our common shares.
In order to raise additional capital, we may in the future offer additional common shares or other securities convertible into or exchangeable for common shares at prices that may not be the same as the price per share in this offering. We cannot assure you that we will be able to sell shares or other securities in any other offering at a price per share that is equal to or greater than the price per share paid by investors in this offering, and investors purchasing shares or other securities in the future could have rights superior to existing shareholders. The price per share at which we sell additional shares of common stock or securities convertible into common stock in future transactions may be higher or lower than the price per share in this offering.
In addition, the sale of shares in this offering and any future sales of a substantial number of shares of common stock in the public market, or the perception that such sales may occur, could adversely affect the price of our common stock. We cannot predict the effect, if any, that market sales of those shares of common stock or the availability of those shares of common stock for sale will have on the market price of our common stock.
Well them the to update their 6 months old website and update quarterly report. Lmao
https://irdirect.net/AYTU/financials
Real companies update.
AYTU Does not have 50 million in the bank.
https://irdirect.net/AYTU/financials
Consolidated Statements of Cash Flows (Unaudited) - USD ($)
6 Months Ended
Dec. 31, 2018
Dec. 31, 2017
Cash flows from operating activities
Net loss
$ (8,104,145) $ (7,917,720)
Adjustments to reconcile net loss to cash used in operating activities
Stock-based compensation expense
106,671 275,688
Issuance of restricted stock
239,505 103,635
Depreciation, amortization and accretion
1,230,671 1,315,063
Issuance of common stock to employee
11,690 0
Derivative (income)
(67,989) (817,785)
Changes in operating assets and liabilities:
(Increase) in accounts receivable
(903,708) (849,397)
(Increase) in inventory
(305,888) (67,585)
(Increase) in prepaid expenses and other
(504,757) (454,595)
Increase in accounts payable and other
252,113 1,124,558
Increase (decrease) in accrued liabilities
746,808 (524,905)
Increase in accrued compensation
203,160 497,586
Increase in interest payable
36,164 0
Increase in deferred revenue
13,990 0
(Decrease) in deferred rent
(1,450) (3,337)
Net cash used in operating activities
(7,047,165) (7,318,794)
Cash flows used in investing activities
Deposits
2,888 0
Purchases of property and equipment
(12,954) (12,195)
Contingent consideration payment
(50,221) 0
Purchase of assets
(800,000) 0
Net cash used in investing activities
(860,287) (12,195)
Cash flows from financing activities
Issuance of preferred, common stock and warrants
15,180,000 11,839,995
Issuance costs related to preferred, common stock and warrants
(1,479,963) (1,402,831)
Issuance of debt
5,000,000 0
Net cash provided by financing activities
18,700,037 10,437,164
Net change in cash, cash equivalents and restricted cash
10,792,585 3,106,175
Cash, cash equivalents and restricted cash at beginning of period
7,112,527 877,542
Cash, cash equivalents and restricted cash at end of period
17,905,112 3,983,717
Fair value of warrants issued to investors and underwriters
1,888,652 0
Issuance of preferred stock related to purchase of asset
519,600 0
Contingent consideration
8,833,219 0
Warrants issued to investors and underwriters (see Note 6)
0 4,117,997
Revenue share payment to Jazz included in accounts payable
0 7,385
Earn-out payment to Nuelle Shareholders
0 250,000
Fixed assets included in accounts payable
$ 0 $ 62,512
Plus
DILUTION
If you invest in this offering, your ownership interest will be immediately diluted to the extent of the difference between the offering price per share of common stock and the as adjusted net tangible book value per share of common stock after this offering.
As of December 31, 2019, we had a net tangible book value of $17,090,240, or $0.82 per share of common stock. Our net tangible book value per share of common stock represents total tangible assets less total liabilities, divided by the number of shares of common stock outstanding at December 31, 2019 (20,733,052 shares of common stock were outstanding as of December 31, 2019).
After giving effect to the issuance and sale by us of 16,000,000 shares of common stock in this offering and Warrants to purchase up to 16,000,000 shares of common stock in the aggregate amount of $20.0 million in this offering at an offering price of $1.25 per share of common stock deducting placement agent fees, our as adjusted net tangible book value as of December 31, 2019 would have been approximately $35,590,240, or approximately $0.97 per share of common stock (assuming 36,733,052 shares of common stock outstanding as of December 31, 2019 after giving effect to the issuance of 16,000,000 shares of common stock in this offering). This amount represents an immediate increase in net tangible book value of $0.15 per share of common stock to our existing shareholders and an immediate dilution in as adjusted net tangible book value of approximately $0.28 per share of common stock to new investors purchasing securities of in this offering.
Dilution per share of common stock to new investors is determined by subtracting as adjusted net tangible book value per share of common stock after this offering from the offering price per share of common stock paid by new investors. The following table illustrates this dilution on a per share of common stock basis:
Offering price per share of common stock $ 1.25
Net tangible book value per share of common stock as of December 31, 2019 $ 0.82
Increase in net tangible book value per share of common stock attributable to this offering 0.15
As adjusted net tangible book value per share of common stock after this offering $ 0.97
Dilution per share of common stock to new investors participating in this offering $ 0.28
Assuming the Warrants and Placement Agent Warrants were immediately exercised, this would result in an as adjusted net tangible book value as of December 31, 2019 would have been $57,215,240 or approximately $1.06 per share of common stock (assuming 53,773,052 shares of common stock outstanding as of December 31, 2019 after giving effect to the issuance of 16,000,000 shares of common stock in this offering, the exercise of the Warrants for 16,000,000 shares of common stock issued in this offering and the exercise of the Placement Agent Warrants for 1,040,000 shares of common stock issued in this offering),which represents an immediate dilution per share to new investors of $0.19 per share of common stock, and an increase in net tangible book value per share to existing shareholders of $0.24 per share of common stock.
The discussion of dilution, and the table quantifying it, assumes the sale of all shares covered by this prospectus supplement and no exercise of any outstanding options or warrants or other potentially dilutive securities. The exercise of potentially dilutive securities having an exercise price less than the offering price would increase the dilutive effect to new investors.
The above discussion and table are based on 20,733,052 common shares outstanding as of December 31, 2019, which does not include the following:
? 1,482 common shares issuable upon the exercise of stock options outstanding as of December 31, 2019 at a weighted average exercise price of $325.54 per share of common stock. As of March 10, 2020, there were 13,937 common shares issuable upon the exercise of stock options outstanding as of March 10, 2020 with a weighted exercise price of 34.69.
?
26,459,663 common shares issuable upon the exercise of warrants outstanding as of December 31, 2019, at a weighted average exercise price of $2.92 per share of common stock, of which 17,030,191 remain outstanding at March 12, 2020 with a weighted average exercise price of $3.76.
? an additional 403,209 common shares that are available for future issuance under our stock option plan, which was subsequently increased by 2,000,000 shares upon receiving shareholder approval on February 13, 2020.
? 17,040,000 shares issuable upon the exercise of the 1,040,000 Placement Agent Warrants or the 16,000,000 Warrants.
? 4,450,000 shares of common stock to be issued in connection with the expected closing of the First RD Offering on March 13, 2020.
? 3,376,087 shares of common stock issuable upon the exercise of the pre-funded warrants to be issued in connection with the First RD Offering on March 13, 2020.
? 508,696 shares of common stock issuable upon the exercise of the warrants issued to H.C. Wainwright & Co., LLC or its assignees in connection with the First RD Offering on March 13, 2020.
? To the extent any of these outstanding options or warrants are exercised, there will be further dilution
I see everyone finally did some DD.
Great job.
That’s not spamming. It’s news.
I read that yesterday it’s sad ppl fall for this.
Well like everyone else I’m at home looking at pump and dump stocks. Easy to see. Dilutions, lies. .... long and shorts are doomed.
If any of my post are wrong than prove it and I will admit I’m wrong. I’m stating facts. Show me your facts regarding AYTU.
DILUTION
If you invest in this offering, your ownership interest will be immediately diluted to the extent of the difference between the offering price per share of common stock and the as adjusted net tangible book value per share of common stock after this offering.
As of December 31, 2019, we had a net tangible book value of $17,090,240, or $0.82 per share of common stock. Our net tangible book value per share of common stock represents total tangible assets less total liabilities, divided by the number of shares of common stock outstanding at December 31, 2019 (20,733,052 shares of common stock were outstanding as of December 31, 2019).
After giving effect to the issuance and sale by us of 16,000,000 shares of common stock in this offering and Warrants to purchase up to 16,000,000 shares of common stock in the aggregate amount of $20.0 million in this offering at an offering price of $1.25 per share of common stock deducting placement agent fees, our as adjusted net tangible book value as of December 31, 2019 would have been approximately $35,590,240, or approximately $0.97 per share of common stock (assuming 36,733,052 shares of common stock outstanding as of December 31, 2019 after giving effect to the issuance of 16,000,000 shares of common stock in this offering). This amount represents an immediate increase in net tangible book value of $0.15 per share of common stock to our existing shareholders and an immediate dilution in as adjusted net tangible book value of approximately $0.28 per share of common stock to new investors purchasing securities of in this offering.
Dilution per share of common stock to new investors is determined by subtracting as adjusted net tangible book value per share of common stock after this offering from the offering price per share of common stock paid by new investors. The following table illustrates this dilution on a per share of common stock basis:
Offering price per share of common stock $ 1.25
Net tangible book value per share of common stock as of December 31, 2019 $ 0.82
Increase in net tangible book value per share of common stock attributable to this offering 0.15
As adjusted net tangible book value per share of common stock after this offering $ 0.97
Dilution per share of common stock to new investors participating in this offering $ 0.28
Assuming the Warrants and Placement Agent Warrants were immediately exercised, this would result in an as adjusted net tangible book value as of December 31, 2019 would have been $57,215,240 or approximately $1.06 per share of common stock (assuming 53,773,052 shares of common stock outstanding as of December 31, 2019 after giving effect to the issuance of 16,000,000 shares of common stock in this offering, the exercise of the Warrants for 16,000,000 shares of common stock issued in this offering and the exercise of the Placement Agent Warrants for 1,040,000 shares of common stock issued in this offering),which represents an immediate dilution per share to new investors of $0.19 per share of common stock, and an increase in net tangible book value per share to existing shareholders of $0.24 per share of common stock.
The discussion of dilution, and the table quantifying it, assumes the sale of all shares covered by this prospectus supplement and no exercise of any outstanding options or warrants or other potentially dilutive securities. The exercise of potentially dilutive securities having an exercise price less than the offering price would increase the dilutive effect to new investors.
The above discussion and table are based on 20,733,052 common shares outstanding as of December 31, 2019, which does not include the following:
? 1,482 common shares issuable upon the exercise of stock options outstanding as of December 31, 2019 at a weighted average exercise price of $325.54 per share of common stock. As of March 10, 2020, there were 13,937 common shares issuable upon the exercise of stock options outstanding as of March 10, 2020 with a weighted exercise price of 34.69.
?
26,459,663 common shares issuable upon the exercise of warrants outstanding as of December 31, 2019, at a weighted average exercise price of $2.92 per share of common stock, of which 17,030,191 remain outstanding at March 12, 2020 with a weighted average exercise price of $3.76.
? an additional 403,209 common shares that are available for future issuance under our stock option plan, which was subsequently increased by 2,000,000 shares upon receiving shareholder approval on February 13, 2020.
? 17,040,000 shares issuable upon the exercise of the 1,040,000 Placement Agent Warrants or the 16,000,000 Warrants.
? 4,450,000 shares of common stock to be issued in connection with the expected closing of the First RD Offering on March 13, 2020.
? 3,376,087 shares of common stock issuable upon the exercise of the pre-funded warrants to be issued in connection with the First RD Offering on March 13, 2020.
? 508,696 shares of common stock issuable upon the exercise of the warrants issued to H.C. Wainwright & Co., LLC or its assignees in connection with the First RD Offering on March 13, 2020.
? To the extent any of these outstanding options or warrants are exercised, there will be further dilution
Not my money. I don’t invest in scammers.
Norwegian Cruise Line Holdings (NCLH) is a holding company that is domiciled in Bermuda and based in the United States.
Same product different supplier. CE LABELED
https://www.confirmbiosciences.com/coronavirus-test/
I take them. And the longs. Save your money. This is a few month/ 1 year virus and 100+ companies are fighting for testing. No need to go all in.
Show me how many Orient Gene Biotech Co. Ltd. is manufacturing for AYTU. At least Abbott and other companies are giving a rough count. We are talking about manufacturing vs purchasing.
Really read your link
The test's maker, Abbott Laboratories, said it expects to deliver 50,000 tests per day beginning next week. The technology behind the test looks for genes that are present in the virus, similar to PCR (polymerase chain reaction) tests already on the market.
Not AYTU. Lol
https://www.cnn.com/2020/03/27/us/15-minute-coronavirus-test/index.html
The tests, which are “serological,” meaning they identify the presence of antibodies in a person’s blood, differ considerably from the molecular testing that is currently in use under Emergency Use Authorization (EUA) by FDA-approved labs and drive-through testing sites. The serological tests show that a person has developed antibodies to SARS-CoV-2, which means they very likely came into contact with it (and either have it, or have already recovered from having it). The molecular tests actually detect the presence of viral DNA in the blood stream, which is a much more definitive indicator that they currently have an active infection
It’s important to note that these tests have not been reviewed or validated by the FDA, unlike those molecular tests that are included in the organization’s emergency use category. Instead, the FDA “does not intend to object to the development and distribution by commercial manufacturers” of these tests, provided they meet a number of criteria, including qualifying the results of their reported test results with the following information:
This test has not been reviewed by the FDA.
Negative results do not rule out SARS-CoV-2 infection, particularly in those who have been in contact with the virus. Follow-up testing with a molecular diagnostic should be considered to rule out infection in these individuals.
Results from antibody testing should not be used as the sole basis to diagnose or exclude SARS-CoV-2 infection or to inform infection status.
Positive results may be due to past or present infection with non-SARS-CoV-2 coronavirus strains, such as coronavirus HKU1, NL63, OC43, or 229E.
https://www.cdc.gov/coronavirus/2019-ncov/lab/guidelines-clinical-specimens.html
Also if you read the full article
according to Josh Disbrow, the company’s CEO.
“We will make them available for sale.
So if you govern needs them AYTU better order 100k more. Because they have them for sale. ppl are reading and spreading this wrong.
https://www.google.com/amp/s/www.denverpost.com/2020/03/20/coronavirus-tests-colorado-aytu-cory-gardner/amp/
Yes but the problem is over 100 companies is applied FDA with these test. AYTU doesn’t make them. Abbott is producing 5 million per month. USA needs them now. AYTU hasn’t got any orders. Let’s say tomorrow the get 1 million order, It will take AYTU 1 month to receive this product. Then repack and ship. In that time Abbott made 5 million in the USA.
AYTU DEBT. NOT BECAUSE COVID-19
The debt-to-equity ratio of 1.39 is relatively high when compared with the subsector average, suggesting a need for better debt level management. Along with the unfavorable debt-to-equity ratio, AYTU maintains a poor quick ratio of 0.76, which illustrates the inability to avoid short-term cash problems.
Return on equity has greatly decreased when compared to its ROE from the same quarter one year prior. This is a signal of major weakness within the corporation. Compared to other companies in the Chemical Manufacturing subsector and the overall market, AYTU BIOSCIENCE INC's return on equity significantly trails that of both the subsector average and the S&P 500.
Net operating cash flow has decreased to -$6.10 million or 41.77% when compared to the same quarter last year. In addition, when comparing the cash generation rate to the subsector average, the firm's growth is significantly lower.
AYTU's stock share price has done very poorly compared to where it was a year ago: Despite any rallies, the net result is that it is down by 36.28%, which is also worse that the performance of the S&P 500 Index. Investors have so far failed to pay much attention to the earnings improvements the company has managed to achieve over the last quarter. Naturally, the overall market trend is bound to be a significant factor. However, in one sense, the stock's sharp decline last year is a positive for future investors, making it cheaper (in proportion to its earnings over the past year) than most other stocks in its subsector. But due to other concerns, we feel the stock is still not a good buy right now.
The gross profit margin for AYTU BIOSCIENCE INC is currently very high, coming in at 81.42%. It has increased from the same quarter the previous year. Regardless of the strong results of the gross profit margin, the net profit margin of -6.74% is in-line with the subsector average.
AYTU BIOSCIENCE INC's gross profit margin for the second quarter of its fiscal year 2020 has increased when compared to the same period a year ago. The company grew its sales and net income significantly quarter versus same quarter a year prior, and was able to outpace the average competitor in the subsector when comparing revenue growth, but not when comparing net income growth. AYTU BIOSCIENCE INC has weak liquidity. Currently, the Quick Ratio is 0.76 which shows a lack of ability to cover short-term cash needs. The company's liquidity has decreased from the same period last year, indicating deteriorating cash flow.
During the same period, stockholders' equity ("net worth") has decreased by 14.11% from the same quarter last year. Overall, the key liquidity measurements indicate that the company is in a position in which financial difficulties could develop in the future.
AYTU isn’t shipping world wide with there 100k unit lmao.
This stock is great for any new or existing investors. All cruise lines will rebound. Everyone loves vacations. Lol
Dear Healthcare Provider,
Aytu BioScience 373 Inverness Parkway, Suite 206 Englewood, CO 80112
Thank you for your interest in the COVID-19 IgG/IgM Rapid Test. This assay provides in vitro qualitative detection of human IgG & IgM antibodies to the SARS-CoV-2 virus (novel coronavirus 2019). The COVID-19 IgG/IgM Rapid Test is intended for use with fingerstick whole blood, venipuncture whole blood, serum, or EDTA plasma specimens of individuals meeting CDC COVID-19 disease clinical and/or epidemiological criteria for testing.
Its intended use is by laboratories in the U.S. that are certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, to perform high or moderate complexity tests, by similarly qualified non-U.S. laboratories, or by healthcare workers at point-of- care.
The U.S. Food and Drug Administration (FDA) has issued an Updated Policy Guidance on March 16, 2020 that enables the commercial availability and distribution of the Aytu BioScience, Inc. (Aytu) COVID-19 IgG/IgM Rapid Test. The COVID-19 IgG/IgM Rapid Test has been validated for use with human whole blood, serum, and EDTA plasma specimen types. However, confirmatory testing requires an approved SARS-CoV-2 nucleic acid amplification test (NAAT). Therefore, if a whole blood, serum, or EDTA plasma sample is used with COVID-19 IgG/IgM Rapid Test, a patient-matched nasopharyngeal swab should also be collected for molecular testing with or soon after the original specimen.
• This test has not been reviewed by the FDA.
• Negative results do not rule out SARS-CoV-2 infection, particularly in those who have
been in contact with the virus.
• Follow-up testing with a molecular diagnostic should be considered to rule out infection
in these individuals.
• Results from antibody testing should not be used as the sole basis to diagnose or
exclude SARS-CoV-2 infection or to inform infection status.
• Positive results may be due to past or present infection with non-SARS-CoV-2
coronavirus strains, such as coronavirus HKU1, NL63, OC43, or 229E.
• Not for the screening of donated blood.
If you have additional questions, please send your communication to medinfo@aytubio.com.
Best Regards,
Aytu BioScience Inc.
All companies got FDA EME APPROVAL
https://www.fda.gov/media/136522/download
Ok those numbers divided by over 100 other companies supplying these test. So one company like AYTU is not going to control the market. It’s everyone supplying anyone lol.
They are required to be CE labeled .....
They are producing 1mil per month.
50,000 per day buddy
https://www.msn.com/en-us/health/health-news/abbott-wins-us-approval-for-test-that-can-detect-coronavirus-in-minutes/ar-BB11OH8R?li=BBnbfcL
https://www.msn.com/en-us/health/health-news/abbott-wins-us-approval-for-test-that-can-detect-coronavirus-in-minutes/ar-BB11OH8R?li=BBnbfcL
Abbott wins U.S. approval for test that can detect coronavirus in minutes
https://www.msn.com/en-us/health/health-news/abbott-wins-us-approval-for-test-that-can-detect-coronavirus-in-minutes/ar-BB11OH8R?li=BBnbfcL
IS ANYONE CONCERN ABOUT
Risks Related to our Financial Position and Need to Raise Additional Capital
We were forced to curtail our operations due to a lack of operating capital and we will not be able to continue as a going concern if we do not obtain additional financing.
Since our inception, we have funded our operations through the sale of our securities. Our cash and restricted cash balances at September 30, 2019 was $50,000. In February 2018 we were forced to curtail our operations. Despite raising $500,000 in gross proceeds through the sale of convertible debentures in July 2018 and $25,000 in December 2018 through the sale of notes, our ability to continue as a going concern is still wholly dependent upon obtaining sufficient capital to fund our operations. We have no committed sources of additional capital and our access to capital funding is always uncertain. Accordingly, despite our ability to secure capital in the past, we cannot assure you that we will be able to secure additional capital through financing transactions, including issuance of debt, or through other means such as the licensing of our technology or grants. In the event that we are not able to secure additional funding, we may be forced to curtail operations, delay or stop ongoing clinical trials, cease operations altogether or file for bankruptcy.
Our auditors have expressed substantial doubt about our ability to continue as a going concern.
Our auditors’ report on our December 31, 2018 financial statements expressed an opinion that our capital resources as of the date of their audit report were not sufficient to sustain operations or complete our planned activities for the upcoming year unless we raised additional funds. Our current cash level raises substantial doubt about our ability to continue as a going concern past the fourth quarter of 2019. If we do not obtain additional funds by such time, we may no longer be able to continue as a going concern and will cease operation which means that our shareholders will lose their entire investment.
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Risks Relating to Our Stage of Development and Business
If we are unable to successfully build a new management team and secure additional members and employees, our business could be harmed.
On July 15, 2019, Christopher Lowe, our chief executive officer, president and principal accounting officer resigned. In February 2018, Ronald Shazer, MD, resigned as our chief medical officer. Effective July 26, 2019, we appointed Michael Cain as our interim Chief Executive Officer and Chief Financial Officer. We will need to continue to augment senior management as well as additional personnel to execute our business plan and grow our business. Our success depends largely on the development and execution of our business strategy by our senior management team. The recent transitions in our executive team may be disruptive to our business, and if we are unable to manage an orderly transition, our business may be adversely affected. Additionally, since our management team consists of only one individual, Mr. Cain, the loss of Mr. Cain would likely harm our ability to implement our business strategy and respond to the rapidly changing market conditions in which we operate. There may be a limited number of persons with the requisite skills to serve in these positions, and we cannot assure you that we would be able to identify or employ such qualified personnel on acceptable terms, if at all. Additionally, we cannot assure you that management will succeed in working together as a team. In the event that we are unsuccessful, our business and prospects could be harmed.
We are an early-stage company, have no product revenues, are not profitable and may never be profitable.
From inception through September 30, 2019, we have raised approximately $36.9 million through the sale of our securities and exercise of outstanding warrants. During this same period, we have recorded an accumulated deficit of approximately $60 million. Our net losses for the two most recent fiscal years ended December 31, 2018 and 2017 were $12,000 and $11.1 million, respectively. Our decrease in net losses is a result of our curtailment of operations beginning February 2018. None of our products in development have received approval from the United States Food and Drug Administration or FDA, or other regulatory authorities; we have no sales and have never generated revenues nor do we expect to for the foreseeable future. We have currently curtailed our pre-clinical and clinical trials related to mipsagargin and are currently focusing our efforts on the development of our adenosine receptor modulators. We expect to incur significant operating losses for the foreseeable future as we continue the research, pre-clinical and clinical development of our product candidates as well as the possible in-licensing of additional clinical and pre-clinical assets. Accordingly, we will need additional capital to fund our continuing operations and any expansion plans. Since we do not generate any revenue, the most likely sources of such additional capital include the sale of our securities, a strategic licensing collaboration transaction or joint venture involving the rights to one or more of our product candidates, or from grants. To the extent that we raise additional capital by issuing equity securities, our stockholders are likely to experience dilution with regard to their percentage ownership of the company, which may be significant. If we raise additional funds through collaborations or licensing arrangements, we may be required to relinquish some or all the rights to our technologies, product candidates, or grant licenses on terms that are not favorable to us. If we raise additional capital by incurring debt, we could incur significant interest expense and become subject to covenants that could affect the manner in which we conduct our business, including securing such debt obligations with our assets.
Our product candidates are at various stages of early development and significant financial resources are required to develop commercially viable products and obtain regulatory approval to market and sell such products. We will need to devote significantly more research and development efforts, financial resources and personnel to develop commercially viable products and obtain regulatory approvals. We may encounter hurdles and unexpected issues as we proceed in the development of our other product candidates. While initial data from our research appear promising, the outcome of the pre-clinical and development work is uncertain and future trials may ultimately be unsuccessful. If we fail to develop and successfully commercialize our product candidates, our business may be materially harmed and could fail.
We have a limited operating history as a company, and may not be able to effectively operate our business.
Our limited staff and operating history means that there is a high degree of uncertainty regarding our ability to:
? develop and commercialize our technologies and proposed products;
? obtain regulatory approval to commence the marketing of our products;
? identify, hire and retain the needed personnel to implement our business plan;
? manage growth;
? achieve market acceptance or insurance reimbursement for any of our proposed products, if successfully developed; or
? respond to competition.
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No assurances can be given as to exactly when, if at all, we will be able to fully develop, and take the necessary steps to derive any revenues from our proposed product candidates.
Raising capital may be difficult as a result of our history of losses and limited operating history in our current stage of development.
When making investment decisions, investors typically look at a company’s management, earnings and historical performance in evaluating the risks and operations of the business and the business’s future prospects. Our history of losses, new senior management team and relatively limited operating history in our current stage of development makes such evaluation, as well as any estimation of our future performance, substantially more difficult. As a result, investors may be unwilling to invest in us or on terms or conditions which are acceptable. If we are unable to secure additional financing, we may need to materially scale back our business plan and/or operations or cease operations altogether.
Risks Related to Commercialization
The market for our proposed products is rapidly changing and competitive.
The pharmaceutical and biotechnology industries are subject to rapid and substantial technological change and innovation. Developments by others may render our proposed products noncompetitive or obsolete, or we may be unable to keep pace with technological developments and other market factors. Competition from pharmaceutical and biotechnology companies, universities, governmental entities and others diversifying into the field is intense and is expected to increase.
As a pre-revenue company, our resources are limited and we may experience challenges inherent in the early development of novel therapeutics. Competitors have developed or are in the process of developing technologies that are, or in the future may be, the basis for competition. Some of these technologies may have an entirely different approach or means of accomplishing similar therapeutic efforts compared to our proposed products. Our competitors may develop therapies that are safer, more effective and less costly than our proposed products and therefore, present a serious competitive threat to us.
The acceptance of therapies that are alternatives to ours may limit market acceptance of our proposed products, even if commercialized. Many of our targeted diseases and conditions can also be treated by other medications and treatments. These treatments may be widely accepted in medical communities and have a longer history of use. The established use of other competing therapies may limit the potential for our proposed products, even if commercialized.
Our proposed products may not be accepted by the healthcare community.
Our proposed products, if approved for marketing, may not achieve market acceptance by the healthcare community since hospitals, physicians, patients or the medical community in general may decide not to utilize them. We are attempting to develop products that are likely to be first approved for marketing as a treatment for late stage cancer where there is no truly effective standard of care. If approved for use in late stage cancer, our proposed products might then be evaluated in earlier stages where they could represent a substantial departure from established treatment methods and would most likely compete with a number of more conventional drugs and therapies which are manufactured and marketed by major pharmaceutical companies. It is too early in the development cycle of our proposed products for us to predict our major competitors. The degree of market acceptance of our products, if developed, will depend on a number of factors, including but not limited to:
? our ability to demonstrate the clinical efficacy and safety of our proposed products to the medical community;
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? our ability to create products that are superior to alternative products;
? our ability to establish in the medical community the potential advantage of our treatments over alternative treatment methods; and
? the reimbursement policies of government and third-party payors.
If the healthcare community does not accept our products, our business could be materially harmed.
Our potential competitors in the biotechnology and pharmaceutical industries have significantly greater resources than we have.
We compete against numerous companies, many of which have substantially greater resources than we have. Several such competitors have research programs and/or efforts to treat the same diseases we target. Companies such as Roche, Novartis, Celgene, Merck & Co., Inc., Johnson & Johnson, and Sanofi S.A., as well as others, have substantially greater financial, research, manufacturing and marketing resources than we do. As a result, such competitors may find it easier to compete in our industry and bring competing products to market.
Risks Related to the Development and Manufacturing of Our Product Candidates
We intend to rely exclusively upon third-party FDA-regulated manufacturers and suppliers for our proposed products.
We currently have no internal manufacturing capability, and intend to rely exclusively on FDA-approved licensees, strategic partners or third party contract manufacturers or suppliers for the foreseeable future. Because manufacturing facilities are subject to regulatory oversight and inspection, the failure of any of our third-party FDA regulated manufactures or suppliers to comply with regulatory requirements could result in material manufacturing delays and product shortages, which could delay or otherwise negatively impact our clinical trials and product development plans. Should we be forced to manufacture our proposed products, we cannot give any assurance that we would be able to develop internal manufacturing capabilities or secure third party suppliers for raw materials. In the event that we seek third party suppliers or alternative manufacturers, they may require us to purchase a minimum amount of materials or could require other unfavorable terms. Any such event could materially impact our business prospects and could delay the development of our proposed products. Moreover, we cannot give any assurance that the contract manufacturers or suppliers that we select will be able to supply our products in a timely or cost effective manner or in accordance with applicable regulatory requirements or our own specifications.
We may not be able to establish or maintain the third-party relationships that are necessary to develop or potentially commercialize our product candidates.
As needed, we plan to rely heavily on third party collaborators, partners, licensees, clinical research organizations, clinical investigators, vendors or other third parties to support our research and development efforts and to conduct clinical trials for our product candidates. We cannot guarantee that we will be able to successfully negotiate agreements for, or maintain relationships with, these third parties on a commercially reasonable basis, if at all. Additionally, to commercialize our proposed products, we intend to rely on third party licensees or the outright sale of our proposed products to pharmaceutical partner(s). If we fail to establish or maintain such third-party relationships as anticipated, our business could be adversely effected.
We are dependent upon third parties to develop our product candidates, and such parties are, to some extent, outside of our control.
We depend upon independent contract research organizations, investigators and collaborators, such as universities and medical institutions, to conduct our pre-clinical and clinical studies. These individuals and/or entities are not our employees and we cannot control the amount or timing of resources that they devote to our programs. These third parties may not assign as great a priority to our programs or pursue them as diligently as we would if we were undertaking such programs ourselves. If these third parties fail to devote sufficient time and resources to our programs, or if their performance is substandard, the development of our drug candidates and corresponding FDA approval could be delayed or fail entirely.
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Our therapeutic compounds may not be able to be manufactured profitably on a large enough scale to support commercialization.
To date, our therapeutic compounds have only been manufactured at a scale which is adequate to supply our research activities and early-stage clinical trials. There can be no assurance that the procedures currently used to manufacture our therapeutic compounds will work at a scale which is adequate for commercial needs. In the event our therapeutic compounds cannot be manufactured in sufficient quantities for commercialization, our future prospects could be significantly impacted and our financial prospects would be materially harmed.
Risks Relating to our Intellectual Property
Our competitive position is dependent on our intellectual property and we may not be able to withstand challenges to our intellectual property rights.
We rely on our intellectual property, including our issued and applied for U.S. and foreign patents as well as our licenses, as the foundation of our business. If our intellectual property rights are challenged, no assurances can be given that our patents or licenses would survive claims alleging invalidity or infringement on other patents and/or licenses. In addition, disputes may arise regarding inventorship of our intellectual property. It is possible that our intellectual property may be infringing upon existing patents that we are not currently unaware of. As the number of participants in the marketplace grows, the possibility of patent infringement claims against us increases. It is difficult, if not impossible, to determine how such disputes would be resolved. Furthermore, because of the substantial amount of discovery required in connection with patent litigation, there is a risk that some of our confidential information could be required to be publicly disclosed. Any litigation claims against us may cause us to incur substantial costs and could place a significant strain upon our financial resources, divert the attention of management or restrict our core business or result in the public disclosure of confidential information.
We may incur substantial costs as a result of litigation or other proceedings relating to patent and other intellectual property rights and we may be unable to protect our rights to, or use of, our technology.
Some or all of our patent applications may not issue as patents, or the claims of any issued patents may not afford meaningful protection for our technologies or products. In addition, patents issued to us or our licensors, if any, may be challenged and subsequently narrowed, invalidated or circumvented. Patent litigation is widespread in the biotechnology industry and could harm our business. Litigation might be necessary to protect our patent position or to determine the scope and validity of third-party proprietary rights. If we choose to go to court to stop someone else from using the inventions claimed in our patents, that individual or company would have the right to ask the court to rule that such patents are invalid and/or should not be enforced against that third party. These lawsuits are expensive and we may not have the required resources to pursue such litigation or to protect our patent rights. In addition, there is a risk that the court might decide that these patents are not valid and that we do not have the right to stop the other party from using the inventions. There is also the risk that, even if the validity of these patents is upheld, the court could refuse to stop the other party on the ground that such other party’s activities do not infringe on our rights contained in these patents.
Furthermore, a third party may claim that we are using inventions covered by their patent rights and may go to court to stop us from engaging in our normal operations and activities, including making or selling our product candidates. These lawsuits are costly and could materially increase our operating expenses and divert the attention of managerial and technical personnel. There is a risk that a court would decide that we are infringing the third party’s patents and would order us to stop the activities covered by the patents. In addition, there is a risk that a court would order us to pay the other party damages for having violated the other party’s patents. The biotechnology industry has produced a proliferation of patents, and it is not always clear to industry participants, including us, which patents cover various types of products or methods of use. The coverage of patents is subject to interpretation by the courts, and the interpretation is not always uniform.
27
Because some patent applications in the United States may be maintained in secrecy until the patents are issued, patent applications in the United States and many foreign jurisdictions are typically not published until eighteen months after filing, and publications in the scientific literature often lag behind actual discoveries, we cannot be certain that others have not filed patent applications for technology covered by our issued patents or our pending applications or that we were the first to invent the technology. Our competitors may have filed, and may in the future file, patent applications covering technology similar to ours. Any such patent application may have priority over our patent applications and could further require us to obtain rights to issued patents covering such technologies.
If another party has filed a United States patent application on inventions similar to ours, we may have to participate in an interference or other proceeding in the U.S. Patent and Trademark Office, or the PTO, or a court to determine priority of invention in the United States. The costs of these proceedings could be substantial, and it is possible that such efforts would be unsuccessful, resulting in a loss of our United States patent position with respect to such inventions.
Some of our competitors may be able to sustain the costs of complex patent litigation more effectively than we can because they have substantially greater resources. In addition, any uncertainties resulting from the initiation and continuation of any litigation could have a material adverse effect on our ability to raise the capital necessary to continue our operations.
Obtaining and maintaining our patent protection depends upon compliance with various procedural, documentary, fee payment and other requirements imposed by governmental patent agencies, and our patent protection could be reduced or eliminated for non-compliance with these requirements.
The PTO and various foreign governmental patent agencies require compliance with a number of procedural, documentary, fee payment and other provisions during the patent process. There are situations in which noncompliance can result in abandonment or lapse of a patent or patent application, resulting in partial or complete loss of patent rights in the relevant jurisdiction. In such an event, competitors might be able to enter the market earlier than would otherwise have been the case.
We may not be able to adequately protect our intellectual property.
We rely in part on trade secret protection in order to protect our proprietary trade secrets and unpatented know-how. However, trade secrets are difficult to protect, and we cannot be certain that others do not develop the same or similar technologies on their own. Additionally, research with regard to our technologies has been performed in countries outside of the United States, and we also anticipate conducting joint ventures, collaborations and future clinical trials outside the US. The laws in some of these countries may not provide protection for our trade secrets and intellectual property. We have taken steps, including entering into confidentiality agreements with our employees, consultants, service providers, and potential strategic partners to protect our trade secrets and unpatented know-how. These agreements generally require that the other party keep confidential and not disclose to third parties all confidential information developed by the party or made known to the party by us during the course of the party’s relationship with us. We also typically obtain agreements from these parties which provide that inventions conceived by the party in the course of rendering services to us are our property. However, these agreements may not be honored, including in foreign countries in which we conduct research, and may not effectively assign intellectual property rights to us. Enforcing a claim that a party illegally obtained and is using our trade secrets or know-how is difficult, expensive and time consuming, and the outcome is unpredictable. In addition, courts outside the United States may be less willing to protect trade secrets or know-how. The failure to obtain or maintain trade secret protection could adversely affect our competitive position.
We may be subject to claims that our employees or consultants have wrongfully used or disclosed alleged trade secrets of their former employers.
As is common in the biotechnology and pharmaceutical industries, we employ and hire individuals and/or entities who were previously employed at other biotechnology or pharmaceutical companies, including our competitors or potential competitors. Although no claims against us are currently pending, we may be subject to claims that these individuals, entities or that we have inadvertently or otherwise used or disclosed trade secrets or other proprietary information of their former employers. Litigation may be necessary to defend against these claims. Even if we are successful in defending against these claims, litigation could result in substantial costs and be a distraction to management.
Our competitive position is dependent on our intellectual property and we may not be able to withstand challenges to our intellectual property rights.
We rely on our intellectual property, including our issued and applied for U.S. and foreign patents as well as our licenses, as the foundation of our business. If our intellectual property rights are challenged, no assurances can be given that our patents or licenses would survive claims alleging invalidity or infringement on other patents and/or licenses. In addition, disputes may arise regarding inventorship of our intellectual property. It is possible that our intellectual property may be infringing upon existing patents that we are not currently unaware of. As the number of participants in the marketplace grows, the possibility of patent infringement claims against us increases. It is difficult, if not impossible, to determine how such disputes would be resolved. Furthermore, because of the substantial amount of discovery required in connection with patent litigation, there is a risk that some of our confidential information could be required to be publicly disclosed. Any litigation claims against us may cause us to incur substantial costs and could place a significant strain upon our financial resources, divert the attention of management or restrict our core business or result in the public disclosure of confidential information.
We may incur substantial costs as a result of litigation or other proceedings relating to patent and other intellectual property rights and we may be unable to protect our rights to, or use of, our technology.
Some or all of our patent applications may not issue as patents, or the claims of any issued patents may not afford meaningful protection for our technologies or products. In addition, patents issued to us or our licensors, if any, may be challenged and subsequently narrowed, invalidated or circumvented. Patent litigation is widespread in the biotechnology industry and could harm our business. Litigation might be necessary to protect our patent position or to determine the scope and validity of third-party proprietary rights. If we choose to go to court to stop someone else from using the inventions claimed in our patents, that individual or company would have the right to ask the court to rule that such patents are invalid and/or should not be enforced against that third party. These lawsuits are expensive and we may not have the required resources to pursue such litigation or to protect our patent rights. In addition, there is a risk that the court might decide that these patents are not valid and that we do not have the right to stop the other party from using the inventions. There is also the risk that, even if the validity of these patents is upheld, the court could refuse to stop the other party on the ground that such other party’s activities do not infringe on our rights contained in these patents.
Furthermore, a third party may claim that we are using inventions covered by their patent rights and may go to court to stop us from engaging in our normal operations and activities, including making or selling our product candidates. These lawsuits are costly and could materially increase our operating expenses and divert the attention of managerial and technical personnel. There is a risk that a court would decide that we are infringing the third party’s patents and would order us to stop the activities covered by the patents. In addition, there is a risk that a court would order us to pay the other party damages for having violated the other party’s patents. The biotechnology industry has produced a proliferation of patents, and it is not always clear to industry participants, including us, which patents cover various types of products or methods of use. The coverage of patents is subject to interpretation by the courts, and the interpretation is not always uniform.
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Because some patent applications in the United States may be maintained in secrecy until the patents are issued, patent applications in the United States and many foreign jurisdictions are typically not published until eighteen months after filing, and publications in the scientific literature often lag behind actual discoveries, we cannot be certain that others have not filed patent applications for technology covered by our issued patents or our pending applications or that we were the first to invent the technology. Our competitors may have filed, and may in the future file, patent applications covering technology similar to ours. Any such patent application may have priority over our patent applications and could further require us to obtain rights to issued patents covering such technologies.
If another party has filed a United States patent application on inventions similar to ours, we may have to participate in an interference or other proceeding in the U.S. Patent and Trademark Office, or the PTO, or a court to determine priority of invention in the United States. The costs of these proceedings could be substantial, and it is possible that such efforts would be unsuccessful, resulting in a loss of our United States patent position with respect to such inventions.
Some of our competitors may be able to sustain the costs of complex patent litigation more effectively than we can because they have substantially greater resources. In addition, any uncertainties resulting from the initiation and continuation of any litigation could have a material adverse effect on our ability to raise the capital necessary to continue our operations.
Obtaining and maintaining our patent protection depends upon compliance with various procedural, documentary, fee payment and other requirements imposed by governmental patent agencies, and our patent protection could be reduced or eliminated for non-compliance with these requirements.
The PTO and various foreign governmental patent agencies require compliance with a number of procedural, documentary, fee payment and other provisions during the patent process. There are situations in which noncompliance can result in abandonment or lapse of a patent or patent application, resulting in partial or complete loss of patent rights in the relevant jurisdiction. In such an event, competitors might be able to enter the market earlier than would otherwise have been the case.
We may not be able to adequately protect our intellectual property.
We rely in part on trade secret protection in order to protect our proprietary trade secrets and unpatented know-how. However, trade secrets are difficult to protect, and we cannot be certain that others do not develop the same or similar technologies on their own. Additionally, research with regard to our technologies has been performed in countries outside of the United States, and we also anticipate conducting joint ventures, collaborations and future clinical trials outside the US. The laws in some of these countries may not provide protection for our trade secrets and intellectual property. We have taken steps, including entering into confidentiality agreements with our employees, consultants, service providers, and potential strategic partners to protect our trade secrets and unpatented know-how. These agreements generally require that the other party keep confidential and not disclose to third parties all confidential information developed by the party or made known to the party by us during the course of the party’s relationship with us. We also typically obtain agreements from these parties which provide that inventions conceived by the party in the course of rendering services to us are our property. However, these agreements may not be honored, including in foreign countries in which we conduct research, and may not effectively assign intellectual property rights to us. Enforcing a claim that a party illegally obtained and is using our trade secrets or know-how is difficult, expensive and time consuming, and the outcome is unpredictable. In addition, courts outside the United States may be less willing to protect trade secrets or know-how. The failure to obtain or maintain trade secret protection could adversely affect our competitive position.
We may be subject to claims that our employees or consultants have wrongfully used or disclosed alleged trade secrets of their former employers.
As is common in the biotechnology and pharmaceutical industries, we employ and hire individuals and/or entities who were previously employed at other biotechnology or pharmaceutical companies, including our competitors or potential competitors. Although no claims against us are currently pending, we may be subject to claims that these individuals, entities or that we have inadvertently or otherwise used or disclosed trade secrets or other proprietary information of their former employers. Litigation may be necessary to defend against these claims. Even if we are successful in defending against these claims, litigation could result in substantial costs and be a distraction to management.
IS ANYONE CONCERN ABOUT
Risks Related to our Financial Position and Need to Raise Additional Capital
We were forced to curtail our operations due to a lack of operating capital and we will not be able to continue as a going concern if we do not obtain additional financing.
Since our inception, we have funded our operations through the sale of our securities. Our cash and restricted cash balances at September 30, 2019 was $50,000. In February 2018 we were forced to curtail our operations. Despite raising $500,000 in gross proceeds through the sale of convertible debentures in July 2018 and $25,000 in December 2018 through the sale of notes, our ability to continue as a going concern is still wholly dependent upon obtaining sufficient capital to fund our operations. We have no committed sources of additional capital and our access to capital funding is always uncertain. Accordingly, despite our ability to secure capital in the past, we cannot assure you that we will be able to secure additional capital through financing transactions, including issuance of debt, or through other means such as the licensing of our technology or grants. In the event that we are not able to secure additional funding, we may be forced to curtail operations, delay or stop ongoing clinical trials, cease operations altogether or file for bankruptcy.
Our auditors have expressed substantial doubt about our ability to continue as a going concern.
Our auditors’ report on our December 31, 2018 financial statements expressed an opinion that our capital resources as of the date of their audit report were not sufficient to sustain operations or complete our planned activities for the upcoming year unless we raised additional funds. Our current cash level raises substantial doubt about our ability to continue as a going concern past the fourth quarter of 2019. If we do not obtain additional funds by such time, we may no longer be able to continue as a going concern and will cease operation which means that our shareholders will lose their entire investment.
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Risks Relating to Our Stage of Development and Business
If we are unable to successfully build a new management team and secure additional members and employees, our business could be harmed.
On July 15, 2019, Christopher Lowe, our chief executive officer, president and principal accounting officer resigned. In February 2018, Ronald Shazer, MD, resigned as our chief medical officer. Effective July 26, 2019, we appointed Michael Cain as our interim Chief Executive Officer and Chief Financial Officer. We will need to continue to augment senior management as well as additional personnel to execute our business plan and grow our business. Our success depends largely on the development and execution of our business strategy by our senior management team. The recent transitions in our executive team may be disruptive to our business, and if we are unable to manage an orderly transition, our business may be adversely affected. Additionally, since our management team consists of only one individual, Mr. Cain, the loss of Mr. Cain would likely harm our ability to implement our business strategy and respond to the rapidly changing market conditions in which we operate. There may be a limited number of persons with the requisite skills to serve in these positions, and we cannot assure you that we would be able to identify or employ such qualified personnel on acceptable terms, if at all. Additionally, we cannot assure you that management will succeed in working together as a team. In the event that we are unsuccessful, our business and prospects could be harmed.
We are an early-stage company, have no product revenues, are not profitable and may never be profitable.
From inception through September 30, 2019, we have raised approximately $36.9 million through the sale of our securities and exercise of outstanding warrants. During this same period, we have recorded an accumulated deficit of approximately $60 million. Our net losses for the two most recent fiscal years ended December 31, 2018 and 2017 were $12,000 and $11.1 million, respectively. Our decrease in net losses is a result of our curtailment of operations beginning February 2018. None of our products in development have received approval from the United States Food and Drug Administration or FDA, or other regulatory authorities; we have no sales and have never generated revenues nor do we expect to for the foreseeable future. We have currently curtailed our pre-clinical and clinical trials related to mipsagargin and are currently focusing our efforts on the development of our adenosine receptor modulators. We expect to incur significant operating losses for the foreseeable future as we continue the research, pre-clinical and clinical development of our product candidates as well as the possible in-licensing of additional clinical and pre-clinical assets. Accordingly, we will need additional capital to fund our continuing operations and any expansion plans. Since we do not generate any revenue, the most likely sources of such additional capital include the sale of our securities, a strategic licensing collaboration transaction or joint venture involving the rights to one or more of our product candidates, or from grants. To the extent that we raise additional capital by issuing equity securities, our stockholders are likely to experience dilution with regard to their percentage ownership of the company, which may be significant. If we raise additional funds through collaborations or licensing arrangements, we may be required to relinquish some or all the rights to our technologies, product candidates, or grant licenses on terms that are not favorable to us. If we raise additional capital by incurring debt, we could incur significant interest expense and become subject to covenants that could affect the manner in which we conduct our business, including securing such debt obligations with our assets.
Our product candidates are at various stages of early development and significant financial resources are required to develop commercially viable products and obtain regulatory approval to market and sell such products. We will need to devote significantly more research and development efforts, financial resources and personnel to develop commercially viable products and obtain regulatory approvals. We may encounter hurdles and unexpected issues as we proceed in the development of our other product candidates. While initial data from our research appear promising, the outcome of the pre-clinical and development work is uncertain and future trials may ultimately be unsuccessful. If we fail to develop and successfully commercialize our product candidates, our business may be materially harmed and could fail.
We have a limited operating history as a company, and may not be able to effectively operate our business.
Our limited staff and operating history means that there is a high degree of uncertainty regarding our ability to:
? develop and commercialize our technologies and proposed products;
? obtain regulatory approval to commence the marketing of our products;
? identify, hire and retain the needed personnel to implement our business plan;
? manage growth;
? achieve market acceptance or insurance reimbursement for any of our proposed products, if successfully developed; or
? respond to competition.
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No assurances can be given as to exactly when, if at all, we will be able to fully develop, and take the necessary steps to derive any revenues from our proposed product candidates.
Raising capital may be difficult as a result of our history of losses and limited operating history in our current stage of development.
When making investment decisions, investors typically look at a company’s management, earnings and historical performance in evaluating the risks and operations of the business and the business’s future prospects. Our history of losses, new senior management team and relatively limited operating history in our current stage of development makes such evaluation, as well as any estimation of our future performance, substantially more difficult. As a result, investors may be unwilling to invest in us or on terms or conditions which are acceptable. If we are unable to secure additional financing, we may need to materially scale back our business plan and/or operations or cease operations altogether.
Risks Related to Commercialization
The market for our proposed products is rapidly changing and competitive.
The pharmaceutical and biotechnology industries are subject to rapid and substantial technological change and innovation. Developments by others may render our proposed products noncompetitive or obsolete, or we may be unable to keep pace with technological developments and other market factors. Competition from pharmaceutical and biotechnology companies, universities, governmental entities and others diversifying into the field is intense and is expected to increase.
As a pre-revenue company, our resources are limited and we may experience challenges inherent in the early development of novel therapeutics. Competitors have developed or are in the process of developing technologies that are, or in the future may be, the basis for competition. Some of these technologies may have an entirely different approach or means of accomplishing similar therapeutic efforts compared to our proposed products. Our competitors may develop therapies that are safer, more effective and less costly than our proposed products and therefore, present a serious competitive threat to us.
The acceptance of therapies that are alternatives to ours may limit market acceptance of our proposed products, even if commercialized. Many of our targeted diseases and conditions can also be treated by other medications and treatments. These treatments may be widely accepted in medical communities and have a longer history of use. The established use of other competing therapies may limit the potential for our proposed products, even if commercialized.
Our proposed products may not be accepted by the healthcare community.
Our proposed products, if approved for marketing, may not achieve market acceptance by the healthcare community since hospitals, physicians, patients or the medical community in general may decide not to utilize them. We are attempting to develop products that are likely to be first approved for marketing as a treatment for late stage cancer where there is no truly effective standard of care. If approved for use in late stage cancer, our proposed products might then be evaluated in earlier stages where they could represent a substantial departure from established treatment methods and would most likely compete with a number of more conventional drugs and therapies which are manufactured and marketed by major pharmaceutical companies. It is too early in the development cycle of our proposed products for us to predict our major competitors. The degree of market acceptance of our products, if developed, will depend on a number of factors, including but not limited to:
? our ability to demonstrate the clinical efficacy and safety of our proposed products to the medical community;
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? our ability to create products that are superior to alternative products;
? our ability to establish in the medical community the potential advantage of our treatments over alternative treatment methods; and
? the reimbursement policies of government and third-party payors.
If the healthcare community does not accept our products, our business could be materially harmed.
Our potential competitors in the biotechnology and pharmaceutical industries have significantly greater resources than we have.
We compete against numerous companies, many of which have substantially greater resources than we have. Several such competitors have research programs and/or efforts to treat the same diseases we target. Companies such as Roche, Novartis, Celgene, Merck & Co., Inc., Johnson & Johnson, and Sanofi S.A., as well as others, have substantially greater financial, research, manufacturing and marketing resources than we do. As a result, such competitors may find it easier to compete in our industry and bring competing products to market.
Risks Related to the Development and Manufacturing of Our Product Candidates
We intend to rely exclusively upon third-party FDA-regulated manufacturers and suppliers for our proposed products.
We currently have no internal manufacturing capability, and intend to rely exclusively on FDA-approved licensees, strategic partners or third party contract manufacturers or suppliers for the foreseeable future. Because manufacturing facilities are subject to regulatory oversight and inspection, the failure of any of our third-party FDA regulated manufactures or suppliers to comply with regulatory requirements could result in material manufacturing delays and product shortages, which could delay or otherwise negatively impact our clinical trials and product development plans. Should we be forced to manufacture our proposed products, we cannot give any assurance that we would be able to develop internal manufacturing capabilities or secure third party suppliers for raw materials. In the event that we seek third party suppliers or alternative manufacturers, they may require us to purchase a minimum amount of materials or could require other unfavorable terms. Any such event could materially impact our business prospects and could delay the development of our proposed products. Moreover, we cannot give any assurance that the contract manufacturers or suppliers that we select will be able to supply our products in a timely or cost effective manner or in accordance with applicable regulatory requirements or our own specifications.
We may not be able to establish or maintain the third-party relationships that are necessary to develop or potentially commercialize our product candidates.
As needed, we plan to rely heavily on third party collaborators, partners, licensees, clinical research organizations, clinical investigators, vendors or other third parties to support our research and development efforts and to conduct clinical trials for our product candidates. We cannot guarantee that we will be able to successfully negotiate agreements for, or maintain relationships with, these third parties on a commercially reasonable basis, if at all. Additionally, to commercialize our proposed products, we intend to rely on third party licensees or the outright sale of our proposed products to pharmaceutical partner(s). If we fail to establish or maintain such third-party relationships as anticipated, our business could be adversely effected.
We are dependent upon third parties to develop our product candidates, and such parties are, to some extent, outside of our control.
We depend upon independent contract research organizations, investigators and collaborators, such as universities and medical institutions, to conduct our pre-clinical and clinical studies. These individuals and/or entities are not our employees and we cannot control the amount or timing of resources that they devote to our programs. These third parties may not assign as great a priority to our programs or pursue them as diligently as we would if we were undertaking such programs ourselves. If these third parties fail to devote sufficient time and resources to our programs, or if their performance is substandard, the development of our drug candidates and corresponding FDA approval could be delayed or fail entirely.
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Our therapeutic compounds may not be able to be manufactured profitably on a large enough scale to support commercialization.
To date, our therapeutic compounds have only been manufactured at a scale which is adequate to supply our research activities and early-stage clinical trials. There can be no assurance that the procedures currently used to manufacture our therapeutic compounds will work at a scale which is adequate for commercial needs. In the event our therapeutic compounds cannot be manufactured in sufficient quantities for commercialization, our future prospects could be significantly impacted and our financial prospects would be materially harmed.
Risks Relating to our Intellectual Property
Our competitive position is dependent on our intellectual property and we may not be able to withstand challenges to our intellectual property rights.
We rely on our intellectual property, including our issued and applied for U.S. and foreign patents as well as our licenses, as the foundation of our business. If our intellectual property rights are challenged, no assurances can be given that our patents or licenses would survive claims alleging invalidity or infringement on other patents and/or licenses. In addition, disputes may arise regarding inventorship of our intellectual property. It is possible that our intellectual property may be infringing upon existing patents that we are not currently unaware of. As the number of participants in the marketplace grows, the possibility of patent infringement claims against us increases. It is difficult, if not impossible, to determine how such disputes would be resolved. Furthermore, because of the substantial amount of discovery required in connection with patent litigation, there is a risk that some of our confidential information could be required to be publicly disclosed. Any litigation claims against us may cause us to incur substantial costs and could place a significant strain upon our financial resources, divert the attention of management or restrict our core business or result in the public disclosure of confidential information.
We may incur substantial costs as a result of litigation or other proceedings relating to patent and other intellectual property rights and we may be unable to protect our rights to, or use of, our technology.
Some or all of our patent applications may not issue as patents, or the claims of any issued patents may not afford meaningful protection for our technologies or products. In addition, patents issued to us or our licensors, if any, may be challenged and subsequently narrowed, invalidated or circumvented. Patent litigation is widespread in the biotechnology industry and could harm our business. Litigation might be necessary to protect our patent position or to determine the scope and validity of third-party proprietary rights. If we choose to go to court to stop someone else from using the inventions claimed in our patents, that individual or company would have the right to ask the court to rule that such patents are invalid and/or should not be enforced against that third party. These lawsuits are expensive and we may not have the required resources to pursue such litigation or to protect our patent rights. In addition, there is a risk that the court might decide that these patents are not valid and that we do not have the right to stop the other party from using the inventions. There is also the risk that, even if the validity of these patents is upheld, the court could refuse to stop the other party on the ground that such other party’s activities do not infringe on our rights contained in these patents.
Furthermore, a third party may claim that we are using inventions covered by their patent rights and may go to court to stop us from engaging in our normal operations and activities, including making or selling our product candidates. These lawsuits are costly and could materially increase our operating expenses and divert the attention of managerial and technical personnel. There is a risk that a court would decide that we are infringing the third party’s patents and would order us to stop the activities covered by the patents. In addition, there is a risk that a court would order us to pay the other party damages for having violated the other party’s patents. The biotechnology industry has produced a proliferation of patents, and it is not always clear to industry participants, including us, which patents cover various types of products or methods of use. The coverage of patents is subject to interpretation by the courts, and the interpretation is not always uniform.
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Because some patent applications in the United States may be maintained in secrecy until the patents are issued, patent applications in the United States and many foreign jurisdictions are typically not published until eighteen months after filing, and publications in the scientific literature often lag behind actual discoveries, we cannot be certain that others have not filed patent applications for technology covered by our issued patents or our pending applications or that we were the first to invent the technology. Our competitors may have filed, and may in the future file, patent applications covering technology similar to ours. Any such patent application may have priority over our patent applications and could further require us to obtain rights to issued patents covering such technologies.
If another party has filed a United States patent application on inventions similar to ours, we may have to participate in an interference or other proceeding in the U.S. Patent and Trademark Office, or the PTO, or a court to determine priority of invention in the United States. The costs of these proceedings could be substantial, and it is possible that such efforts would be unsuccessful, resulting in a loss of our United States patent position with respect to such inventions.
Some of our competitors may be able to sustain the costs of complex patent litigation more effectively than we can because they have substantially greater resources. In addition, any uncertainties resulting from the initiation and continuation of any litigation could have a material adverse effect on our ability to raise the capital necessary to continue our operations.
Obtaining and maintaining our patent protection depends upon compliance with various procedural, documentary, fee payment and other requirements imposed by governmental patent agencies, and our patent protection could be reduced or eliminated for non-compliance with these requirements.
The PTO and various foreign governmental patent agencies require compliance with a number of procedural, documentary, fee payment and other provisions during the patent process. There are situations in which noncompliance can result in abandonment or lapse of a patent or patent application, resulting in partial or complete loss of patent rights in the relevant jurisdiction. In such an event, competitors might be able to enter the market earlier than would otherwise have been the case.
We may not be able to adequately protect our intellectual property.
We rely in part on trade secret protection in order to protect our proprietary trade secrets and unpatented know-how. However, trade secrets are difficult to protect, and we cannot be certain that others do not develop the same or similar technologies on their own. Additionally, research with regard to our technologies has been performed in countries outside of the United States, and we also anticipate conducting joint ventures, collaborations and future clinical trials outside the US. The laws in some of these countries may not provide protection for our trade secrets and intellectual property. We have taken steps, including entering into confidentiality agreements with our employees, consultants, service providers, and potential strategic partners to protect our trade secrets and unpatented know-how. These agreements generally require that the other party keep confidential and not disclose to third parties all confidential information developed by the party or made known to the party by us during the course of the party’s relationship with us. We also typically obtain agreements from these parties which provide that inventions conceived by the party in the course of rendering services to us are our property. However, these agreements may not be honored, including in foreign countries in which we conduct research, and may not effectively assign intellectual property rights to us. Enforcing a claim that a party illegally obtained and is using our trade secrets or know-how is difficult, expensive and time consuming, and the outcome is unpredictable. In addition, courts outside the United States may be less willing to protect trade secrets or know-how. The failure to obtain or maintain trade secret protection could adversely affect our competitive position.
We may be subject to claims that our employees or consultants have wrongfully used or disclosed alleged trade secrets of their former employers.
As is common in the biotechnology and pharmaceutical industries, we employ and hire individuals and/or entities who were previously employed at other biotechnology or pharmaceutical companies, including our competitors or potential competitors. Although no claims against us are currently pending, we may be subject to claims that these individuals, entities or that we have inadvertently or otherwise used or disclosed trade secrets or other proprietary information of their former employers. Litigation may be necessary to defend against these claims. Even if we are successful in defending against these claims, litigation could result in substantial costs and be a distraction to management.
AYTU doesn’t have exclusive rights. Labrador Diagnostics LLC has granted patent rights to everyone for testing. US Patents 8,283,155 and 10,533,994). https://www.biospace.com/article/releases/labrador-diagnostics-will-grant-royalty-free-licenses-for-covid-19-testing/ Good luck Longs but this is going south everyday. Read the headlines.
There is over 100 companies applied for testing with the FDA