Forward-looking Statements
This Quarterly Report on Form 10-Q contains certain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other Federal securities laws, and is subject to the safe-harbor created by such Act and laws. In some cases, you can identify forward-looking statements by terminology such as "may," "will," "should," "expect," "intend," "plan," "anticipate," "believe," "estimate," "predict," "potential" or "continue," the negative of such terms, or other variations thereon or comparable terminology. The statements herein and their implications are merely predictions and therefore inherently subject to known and unknown risks, uncertainties, assumptions and other factors that may cause actual results, performance levels of activity, or our achievements, or industry results to be materially different from those contemplated by the forward-looking statements. Except as required by law, we undertake no obligation to release publicly the result of any revision to these forward-looking statements that may be made to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. Further information on potential factors that could affect our business is described under the heading "Risk Factors" in our registration statement on Form S-1 as filed with theSecurities and Exchange Commission , or theSEC , onOctober 28 , 2021As used in this quarterly report, the terms "we", "us", "our", the "Company" and "AppYea" meanAppYea, Inc. and our wholly-owned subsidiariesSleepx LTD andTa-Nooma LTD unless otherwise indicated or as otherwise required by the context. OverviewAppYea, Inc. is a digital health company, focused on the development of accurate wearable monitoring solutions to treat sleep apnea and snoring and fundamentally improve quality of life.
Our solutions are based on our proprietary intellectual property portfolio comprised of Artificial Intelligence (AI) and sensing technologies for the tracking, analysis, and diagnosis of vital signs and other physical parameters during sleep time, offering extreme accuracy at affordable cost.
AI is a broad term generally used to describe conditions where a machine mimics "cognitive" functions associated with human intelligence, such as "learning" and "problem solving. Basic AI includes machine learning, where a machine uses algorithms to parse data, learn from it, and then make a determination or prediction about a given phenomenon. The machine is "trained" using large amounts of data and algorithms that provide it with the ability to learn how to perform the task. General Background Snoring is a general disorder caused due to repetitive collapsing and narrowing of the upper airway. Individuals with snoring problems are at increased risk of accidental injury, depression and anxiety, heart disease and stroke. Currently available treatments include surgical and non-surgical devices. According to Fior Markets, a market intelligence company, the Global Anti-Snoring Treatment Market is expected to grow fromUSD 4.3 billion in 2020 toUSD 8.6 billion by 2028, with a 9.07% CAGR between 2021 and 2028. WhileNorth America had the largest market share of 28.12% in 2020,Asia-Pacific region is witnessing significant growth due to the increasing prevalence of obesity and sedentary lifestyles in emerging economies. Currently available anti-snoring devices consist mainly of oral appliances that are recommended for use by patients suffering of snoring or obstructive sleep apnea. These appliances are put before sleep and have a simple function of pushing either the lower jaw or the tongue forward. This keeps the epiglottis parted from the uvula and prevents the snoring sound created by the vibration of soft tissues of palate. Sleep apnea is a severe sleep condition in which individuals frequently stop breathing in their sleeping, this leads to insufficient oxygen supply to the brain and the rest of the body which, in turn may lead to critical problems. There are three main types of apnea: (i) Obstructive Sleep Apnea ("OSA"), the most common form caused by the throat muscles relaxing during sleep; (ii) Central sleep apnea, which occurs when the brain doesn't send the proper signals to the muscles that control the breathing; and (iii) complex sleep apnea syndrome, which occurs when an individual suffers from both OSA and central sleep apnea. While OSA is a common disorder in the elderly population, affecting approximately 13 to 32% of people aged over 65, sleep apnea can occur at any age and affects approximately 25% of men and nearly 10% of women. 18 In 2020,North America dominated the sleep apnea device market, as it accounted for 49% of the revenue, the global market size was valued atUSD 3.7 billion and is expected to expand by 6.2% CAGR, according to a report byGrand View Research Inc. , reachingUSD 6.1 billion by 2028. The global sleep apnea and snoring market is driven in large part by solutions that can be applied in at home-settings or healthcare settings, as these tools will drive decisions regarding specific treatments and the associated outlays. However, despite advances in medical imaging and other diagnostic tools, misdiagnosis remains a common occurrence. We believe that improved diagnoses and outcomes are achievable through the adoption of AI-based decision support tools.
Our Products and Product Candidates
Our initial focus is on the development of supporting solutions utilizing our proprietary platform. Our current business plan focuses on two principal devices and an App currently in development:
DreamIT - Biofeedback snoring treatment wristband, combined with the SleepX App.
This wristband uses unique algorithms designed by SleepX combined with sensors to monitor physiological parameters during sleep. Based on real time reactions, the wristband will vibrate, when necessary, in order to decrease the snoring and regulate breathing by gently bringing the user to a lighter sleep and thus ceasing the snoring event.
The DreamIT product is currently in testing and calibration stage in preparation for serial manufacturing.
DreamIT PRO - is a wristband for the treatment of sleep apnea using biofeedback in combination with SleepX PRO app. The unique algorithms of SleepX PRO, combined with the wristband sensors, monitor sleep apnea events and additional physiological parameters during sleep, and when necessary, the wristband vibrates according to real time events, in order to decrease and cease sleep apnea events. The DreamIT PRO product is currently in advanced development stages, following which it would be ready to begin the testing stage in preparation for filing for FDA approval.
SleepX PRO - Is a medical application, available for downloading on a smartphone, and used to monitor breathing patterns in the sleep and identify sleep apnea episodes without direct contact to the user.
The SleepX PRO product is currently awaiting approval from the
Recent Corporate History Reverse Merger OnAugust 2, 2021 ,AppYea entered into a stock exchange agreement withSleepX Ltd. , a company formed under the laws of theState of Israel ("SleepX") and controlled by the majority shareholder ofAppYea , our chief executive officer Barry Molchadsky. Pursuant to the agreement, the outstanding equity capital consisting of 1,724 common shares of SleepX was exchanged for 174,595,634 shares of common stock of the Company, based on the agreement that determined that to SleepX shareholders will be issued common shares in the amount that will result in them holding 80% of the common shares issued ofAppYea . The agreement was subject to certain terms before the agreement could be closed. OnDecember 31, 2021 , the agreement was consummated as the terms of the agreement were fulfilled; As a result, SleepX became a wholly owned subsidiary of the Company. The issuance of the shares to SleepX shareholders, due to administrative matters was completed inMarch 2022 after the Company completed a reverse stock split. In anticipation of the reverse merger described below, onJuly 2, 2021 , Boris Molchadsky a majority shareholder of the Company, acquired in a private transaction from the former majority shareholder two hundred and twenty-five thousand (225,000) Shares of Series A Preferred Stock of the Company. The Series A Preferred Shares have the right to vote 1,000 to 1 as shares of common stock and are convertible into 1,500 to 1 of the shares of common stock of the Company. The acquisition of the Preferred Shares provides Boris Molchadsky control of a majority of the Company's voting equity capital. 19 Funding arrangements (i) OnNovember 24, 2021 , the Company andLeonite Capital LLC ("Leonite") entered into a securities purchase agreement ("SPA") pursuant to which Leonite purchased a 8% secured convertible promissory note (the "Note") in the aggregate principal amount of amount of$588,235.29 (the "Principal Amount"). The Note carries an original issue discount of$88,235.29 (the "OID"), which is included in the principal balance of the Note. Thus, the purchase price of the Note is$500,000 computed as follows: the Principal Amount minus the OID. Leonite remitted to us onNovember 24, 2021 $110,000 , less$10,000 to cover Leonite's expenses, and remitted the balance of$390,000 onMay 9, 2022 , advanced upon the filing of the Registration Statement on Form S-1. Under the terms of the SPA, we issued, as a commitment fee, to Leonite 200,000 shares of our common stock onNovember 24, 2021 and 300,000 warrants to purchase additional shares of our common stock at a post-split per share exercise price of$0.6 . Upon receipt of the balance of the committed amount, we issued to Leonite an additional 200,000 shares of our common stock and 300,000 warrants to purchase additional shares of our common stock at a per share exercise price of$0.6 .
The maturity date of the Note is the earlier of 12 months from the date of each advance or the date the Company closes on a registered public offering (the "Maturity Date"). The Note bears interest at the greater of (i) the Prime Rate plus two percent (2%) per annum, or (ii) eight percent (8%) (the "Interest Rate"), which reset daily and shall accrue on a monthly basis and is payable on the first of each month following the date on which the Note was issued. The final payment of the Principal Amount and interest shall be paid by us to the Leonite on the Maturity Date. Leonite is entitled to, from time to time convert all or any amount of the Principal Amount and any accrued but unpaid interest of the Note into Common Stock, at a conversion price (the "Conversion Price")
equal to$0.50 (post-split). Following an event of default, the Note bears interest rate of 24% per annum with a Conversion Price equal to the lesser of (i) the$0.50 ; (ii) sixty percent (60%) of the lowest trading price during the twenty one (21) consecutive trading day period immediately preceding the Trading Day that the Company receives a Notice of Conversion, but in any case not lower than$0.04 (on a post split basis).
The outstanding principal amount of the Note is secured by substantially all of the assets of the Company.
Under the terms of the Note, the occurrence of any of the following constitute events of default (each an "Event of Default"): (i) the Company's failure to pay the principal, principal or other sum when due and such failure continues for three business days after the due date, (ii) the Company's failure to reserve a sufficient number of shares or issue shares as required under the SPA, (iii) breach of any material covenant or other term or condition of the SPA or any other transaction document in any material respect, (iv) ) the assignment by the Company for the benefit of creditors or application for or consent to the appointment of a receiver or trustee, or such receiver or trustee shall otherwise be appointed, (v) the entry of a monetary judgment or similar process in excess of$100,000 if such judgment remains unvacated for 45 day, (vi) if we are delisted from our current trading market, (vii) cessation of operations or failure to maintain assets to operate our business, (viii) a restatement of our financial statements, (ix) cross defaults or entering into a variable rate transaction, (x) DTC "chill", (xi) absence of a bid price for three trading days and (xii) the failure of this Registration Statement to be declared effective bySeptember 24, 2022
Under the SPA we agreed that Leonite, while the Note is outstanding, has a right of first refusal on any financing that we may undertake as well as Leonite's right, throughMay 24, 2023 , to participate in any future financing. (ii) OnAugust 22, 2021 Evergreen Venture partners LLC, owned byDouglas O. McKinnon , former CEO of the company, agreed to advance to the Company up to$265,000 in tranches under the terms of an 18 month unsecured promissory note. Under the terms of the note, which bears interest at a rate of 8% per annum, the investor can convert the note into shares of common stock at 35% discount to the highest daily trading price over the 10 days' preceding conversion but in any event not less than$0.1 per share. The note contains standard events of default. As of theDecember 31, 2021 , we were advanced$25,000 under the Note and there are no assurances that can be provided that additional funds will
be forthcoming. (iii) InNovember 2021 , we entered into a convertible loan agreement with for$250,000 with a maturity date ofMay 2023 . The loan is convertible at a price equal to the offering price of the company registration statement. 20
Key Financial Terms and Metrics
The following discussion summarizes the key factors our management believes are necessary for an understanding of our consolidated financial statements.
Revenues
We have not generated any revenues from product sales to date.
Research and Development Expenses
The process of researching and developing our product candidates is lengthy, unpredictable, and subject to many risks. We expect to continue incurring substantial expenses for the next several years as we continue to develop our product candidates. We are unable, with any certainty, to estimate either the costs or the timelines in which those expenses will be incurred. The design and development of our devices will consume a large proportion of our current,
as well as projected, resources.
Our research and development costs include costs are comprised of:
? internal recurring costs, such as personnel-related costs (salaries, employee benefits, equity compensation and other costs), materials and supplies, facilities and maintenance costs attributable to research and development functions; and
? fees paid to external parties who provide us with contract services, such as programming, preclinical testing, manufacturing and related testing and clinical trial activities.
General and Administrative Expenses
General and administrative expenses consist primarily of salaries, employee benefits, equity compensation, and other personnel-related costs associated with executive, administrative and other support staff. Other significant general and administrative expenses include the costs associated with professional fees for accounting, auditing, insurance costs, consulting and legal services, along with facility and maintenance costs attributable to general and administrative functions. Financial Expenses Financial expenses consist primarily impact of exchange rate derived from re-measurement of monetary balance sheet items denominated in non-dollar currencies. Other financial expenses include bank's fees and interest on long term loans. Financial income derives mainly from change in derivative value
of convertible loans. Results of Operations
Comparison of the Three and Nine Months Ended
For the three- months period ended For the nine- months period ended September 30 September 30 2022 2021 2022 2021 U.S dollars (in thousands) Research and development expenses 31 4 73 70 General and administrative expenses 513 156 1,592 186 Financing expenses, net (19 ) (1 ) (65 ) (2 ) Loss for the period (683 ) (161 ) (738 ) (258 ) 21
Revenues. We have not recorded any revenues to date.
Research and Development Expenses, Research and development expenses increased from$4,000 and$70,000 during the three and nine months endedSeptember 30, 2021 to$31,000 and$73,000 , respectively, for the corresponding periods in 2022. The increase in each of the three and nine month periods is primarily attributable to investment in intellectual property and development of our products.
General and Administrative Expenses. General and administrative expenses
increased from
Loss. Loss for the three months and nine months endedSeptember 30, 2022 was$683,000 and$738,000 , and is primarily attributable to non-cash stock based compensation expenses referred to above.
Liquidity and Capital Resources
From inception and through the date of the Acquisition, we have funded our operations from a combination of loans and sales of equity instruments.
As of
AppYea has experienced operating losses since its inception and had a total accumulated deficit of$3,943,000 as ofSeptember 30, 2022 . We expect to incur additional costs and require additional capital. We have incurred losses in nearly every year since inception. These losses have resulted in significant cash used in operations. During the fiscal quarters endedSeptember 30, 2022 and 2021, our cash used in operations was approximately$108,000 and$26,000 , respectively. We need to continue and amplify our research and development efforts for our product candidates (which are in various stages of development), strengthen our patent portfolio, establish operations processes and pursue FDA clearance and international regulatory approvals as we continue to conduct these activities, we expect the cash needed to fund operations to increase significantly over the next several years. We need to raise additional operating capital in order to maintain operations and realize our business plan. Management believes that funds on hand, will enable us to fund our operations and capital expenditure requirements throughDecember 2022 . Our requirements for additional capital during this period will depend on many factors, including the following:
? the scope, rate of progress, results and cost of our development and
engineering efforts to develop our devices, clinical studies (to the extent
necessary), preliminary testing activities and other related activities;
? the cost, timing and outcomes of regulatory related efforts for commercial
sales approvals;
? the cost and timing of establishing sales, marketing and distribution
capabilities;
? the terms and timing of any collaborative, licensing and other arrangements
that we may establish;
? the timing, receipt and amount of sales, profit sharing or royalties, if any,
from our potential products;
? the cost of preparing, filing, prosecuting, defending and enforcing any patent
claims and other intellectual property rights; and
? the extent to which we acquire or invest in businesses, products or
technologies, although we currently have no commitments or agreements relating
to any of these types of transactions. Our accompanying consolidated financial statements have been prepared assuming the Company will continue as a going concern, which contemplates realization of assets and the satisfaction of liabilities in the normal course of business for the twelve-month period following the date of these consolidated financial statements. However, the Company has incurred substantial losses. Our current liabilities exceed our current assets and available cash is not sufficient to fund the expected future operations. The Company is raising additional capital through debt and equity securities in order to continue the funding of its operations. However, there is no assurance that the Company can raise enough funds or generate sufficient revenues to pay its obligations as they become due, which raises substantial doubt about our ability to continue as a going concern. No adjustments have been made to the carrying value of assets or liabilities as a result of this uncertainty.
We cannot be sure that future funding will be available to us on acceptable terms, or at all. Due to often volatile nature of the financial markets, equity and debt financing may be difficult to obtain.
22
We may seek to raise any necessary additional capital through a combination of private or public equity offerings, debt financings, collaborations, strategic alliances, licensing arrangements and other marketing and distribution arrangements. To the extent that we raise additional capital through marketing and distribution arrangements or other collaborations, strategic alliances or licensing arrangements with third parties, we may have to relinquish valuable rights, future revenue streams, or product candidates or to grant licenses on terms that may not be favourable to us. If we raise additional capital through private or public equity offerings, the ownership interest of our existing stockholders will be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect our stockholders' rights. If we raise additional capital through debt financing, we may be subject to covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends. Going Concern The accompanying consolidated financial statements have been prepared assuming that we will continue as a going concern. We have a stockholders' deficit of$2,264,000 and a working capital of ($2,410,000 ) atSeptember 30, 2022 as well as negative operating cash flows. These conditions raise substantial doubt about our ability to continue as a going concern. The consolidated financial statements do not include any adjustments that might be necessary if we are unable to continue as a going concern.
Off-Balance Sheet Arrangements
We do not have any off-balance sheet arrangements.
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