UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
MARK ONE
for
the Quarterly Period ended
for the transition period from ________ to ________
Commission
File Number:
(Exact name of registrant as specified in its charter)
| (State or other jurisdiction of | (I.R.S. Employer | |
| incorporation or organization) | Identification No.) |
| (Address of principal executive offices) | Zip Code |
+
(Registrant’s telephone number, including area code)
Securities registered pursuant to Section 12(b) of the Act:
| Title of each class | Trading Symbol(s) | Name of each exchange on which registered | ||
| N/A | N/A | N/A |
Indicate
by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange
Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2)
has been subject to such filing requirements for the past 90 days.
Indicate
by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data
File required to be submitted and posted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding
12 months (or for such shorter period that the registrant was required to submit and post such files).
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
| Large accelerated filer | ☐ | Accelerated filer | ☐ |
| ☒ | Smaller reporting company | ||
| Emerging growth company |
If
an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying
with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.
Indicate
by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐
As of May 15, 2023, there were outstanding shares of the registrant’s common stock, par value $0.001 per share.
IR-MED, INC.
Form 10-Q
March 31, 2023
| 2 |
IR-Med .Inc
Interim Unaudited Condensed Consolidated Balance Sheets
March 31 2023 | December 31 2022 | |||||||
| U.S dollars (in thousands) | ||||||||
| Assets | ||||||||
| Current assets | ||||||||
| Cash and cash equivalents | ||||||||
| Accounts receivable | ||||||||
| Total current assets | ||||||||
| Non- current assets | ||||||||
| Long term restricted deposit | ||||||||
| Operating lease right of use assets | ||||||||
| Property and equipment, net | ||||||||
| Total non-current assets | ||||||||
| Total assets | ||||||||
| Liabilities and Stockholders’ equity | ||||||||
| Current liabilities | ||||||||
| Trade and other payables | ||||||||
| Total current liabilities | ||||||||
| Non-current liabilities | ||||||||
| Long term lease liability | ||||||||
| Total liabilities | ||||||||
| Stockholders’ Equity | ||||||||
| Common Stock, par value $ per share, , shares authorized. as of March 31, 2023 and December 31, 2022; and shares issued, respectively. | ||||||||
| Additional paid-in capital | ||||||||
| Accumulated deficit | ( | ) | ( | ) | ||||
| Total Stockholders’ equity | ||||||||
| Total liabilities and stockholders’ equity | ||||||||
The accompanying notes are an integral part of these interim unaudited condensed consolidated financial statements.
| 3 |
IR-Med .Inc
Interim Unaudited Condensed Consolidated Statements of Operations
For the three-month period ended March 31 | ||||||||
| 2023 | 2022 | |||||||
| U.S dollars (in thousands) | ||||||||
| Research and development expenses
| ||||||||
| Marketing expenses | ||||||||
| General and administrative expenses | ||||||||
| Total operating loss | ||||||||
| Financial income, net | ( | ) | ( | ) | ||||
| Loss for the period | ||||||||
| Basic and dilutive loss
per common stock (in dollars) | ( | ) | ( | ) | ||||
The accompanying notes are an integral part of these interim unaudited condensed consolidated financial statements.
| 4 |
IR-Med .Inc
Interim Unaudited Condensed Consolidated Statements of Changes in Stockholders’ Equity
| Common Stock | Additional | Total | ||||||||||||||||||
| Number of | paid-in | Accumulated | Stockholders’ | |||||||||||||||||
| Shares | Amount | Capital | deficit | equity | ||||||||||||||||
| U.S dollars (in thousands) | ||||||||||||||||||||
| For the three-month period ended March 31, 2023 | ||||||||||||||||||||
| Balance as of January 1, 2023 | ( | ) | ||||||||||||||||||
| Stock-based compensation | * | |||||||||||||||||||
| Loss for the period | - | ( | ) | ( | ) | |||||||||||||||
| Balance as of March 31, 2023 | ( | ) | ||||||||||||||||||
| (*) |
| Common Stock | Additional | Total | ||||||||||||||||||
| Number of | paid-in | Accumulated | Stockholders’ | |||||||||||||||||
| Shares | Amount | Capital | deficit | equity | ||||||||||||||||
| U.S dollars (in thousands) | ||||||||||||||||||||
| For the three-month period ended March 31, 2022 | ||||||||||||||||||||
| Balance as of January 1, 2022 | ( | ) | ||||||||||||||||||
| Stock-based compensation | - | |||||||||||||||||||
| Loss for the period | - | ( | ) | ( | ) | |||||||||||||||
| Balance as of March 31, 2022 | ( | ) | ||||||||||||||||||
The accompanying notes are an integral part of these interim unaudited condensed consolidated financial statements.
| 5 |
IR-Med .Inc
Interim Unaudited Condensed Consolidated Statements of Cash Flows
| For the three-month period ended | ||||||||
| March 31 | March 31 | |||||||
| 2023 | 2022 | |||||||
| U.S dollars (in thousands) | ||||||||
| Cash flows from operating activities | ||||||||
| Loss for the period | ( | ) | ( | ) | ||||
| Adjustments to reconcile loss for the period to net cash | ||||||||
| used in operating activities: | ||||||||
| Stock based compensation | ||||||||
| Depreciation | ||||||||
| Accrued financial income | ( | ) | ( | ) | ||||
| Increase in accounts receivable | ( | ) | ( | ) | ||||
| (Decrease) increase in trade and other payables | ( | ) | ||||||
| Net cash used in operating activities | ( | ) | ( | ) | ||||
| Cash flows from investing activities | ||||||||
| Purchase of property and equipment | ( | ) | ||||||
| increase in long term deposit | ( | ) | ||||||
| Net cash used in investing activities | ( | ) | ||||||
| Effect of exchange rate changes on cash and cash equivalents | ( | ) | ||||||
| Net Decrease in cash and cash equivalents | ( | ) | ( | ) | ||||
| Cash and cash equivalents as at the beginning of the period | ||||||||
| Cash and cash equivalents as at the end of the period | ||||||||
| Supplemental disclosure of cash flow information: | ||||||||
| Non-cash transactions: | ||||||||
| (Decrease) increase in non-current assets from recording of rights of use assets | ||||||||
| Increase (decrease) in non-current liabilities from recording of liability of lease agreements | ( | ) | ||||||
The accompanying notes are an integral part of these interim unaudited condensed consolidated financial statements.
| 6 |
IR-Med .Inc
Notes to the Interim Unaudited Condensed Consolidated Financial Statements
Note 1 - General
| A. | Description of Business |
IR-Med, Inc. (OTC QB: IRME, hereinafter: the “Parent Company”) was incorporated in Nevada in 2007 and is a holding company.
The registered office of IR-Med, Inc. and the corporate headquarters and research facility of IR. Med Ltd. are located in Rosh Pina, Israel.
The Company is a development stage medical device company developing its technology through its Subsidiary and is utilizing Infra-Red light spectroscopy (IR) combined with Artificial Intelligence (AI) technology platform to develop non-invasive devices for various medical indications, by detecting and measuring various biomarkers and molecules in the blood and in human tissue in real-time. The initial product candidates which are currently in various stages of development are non-invasive, user friendly and designed to address the medical needs of large and growing target patient groups by offering earlier and more accurate information for detection, which is expected to reduce healthcare expenses and reducing the widespread reliance on antibiotics administration, and other interventional options optimizing the delivery of the targeted medical services and, as a result, improving the efficacy and safety of administered treatments.
| B. | Going Concern |
The
Company is in its development stage and does not expect to generate significant revenue until such time as the Company shall have completed
the design and development of its initial product candidate and obtained the requisite approvals to market the product. During the three
months ended March 31, 2023, the Company has incurred losses of US$
Management’s plans regarding these matters include continued development and marketing of its products, as well as seeking additional financing arrangements. Although management continues to pursue these plans, there is no assurance that the Company will be successful in raising the needed capital from revenues or financing on commercially acceptable terms. The financial statements do not include any adjustments that might result from the outcome of this uncertainty. Management’s plans regarding these matters include continued development and marketing of its products, as well as seeking additional financing arrangements. As a result of the Company’s financial condition, substantial doubt exists that the Company will be able to continue as a going concern for one year from the issuance date of this first quarter of 2023 Report.
| 7 |
IR-Med Inc.
Notes to the Interim Unaudited Condensed Consolidated Financial Statements
Note 2 - Interim Unaudited Financial Information
The accompanying unaudited financial statements of the Company have been prepared in accordance with U.S. generally accepted accounting principles (“U.S GAAP”) for interim financial information. Accordingly, they do not include all of the information and footnotes required by U.S. GAAP for complete financial statements and therefore should be read in conjunction with the Company’s Annual Report on for the year ended December 31, 2022.
In the opinion of management, all adjustments considered necessary for a fair statement, consisting of normal recurring adjustments, have been included. Operating results for the three month period ended March 31, 2023 are not necessarily indicative of the results that may be expected for the year ending December 31, 2023.
Use of Estimates:
The preparation of financial statements in conformity with U.S GAAP requires management to make judgments, estimates and assumptions that affect the reported amounts of assets and liabilities and disclosures of contingent assets and liabilities at the date of the consolidated financial statements, and the reported amounts of expenses during the reporting period. Significant items subject to such estimates and assumptions including fair value of warrants and the share-based compensation. Actual results could differ from those estimates.
Note 3 - Significant Accounting Policies
These interim unaudited condensed consolidated financial statements have been prepared according to the same accounting policies as those discussed in the Company’s Annual Report for the year ended December 31, 2022.
On December 23, 2020 the Group’s board of directors approved and the shareholders adopted a share-based compensation plan (“2020 Incentive Stock Plan”) for future grants by the Parent Company.
As of March 31, 2023, the Parent Company awarded to its employees and service providers options to purchase up to shares of Common Stock, of which options for shares were at an exercise price of US$ per share, options for shares were at an exercise price of US$ per share, options for shares were at an exercise price of US$ per share and options for shares
| 8 |
IR-Med Inc.
Notes to the Interim Unaudited Condensed Consolidated Financial Statements
Note 4 - Stock options plan (Cont’d)
were
at an exercise price of $ per share. As of March 31, 2023 options for shares were vested and the remaining balance has
a vesting period ranging between to
The grant was approved following the adoption of the 2020 incentive stock plan (hereinafter the “Plan”) by the Parent Company on December 23, 2020 and the adoption of the sub plan (the “Israeli appendix”) on April 29, 2021. The Group recorded in the statement of operations a non-cash expense of $ thousands and $ thousands during the three months ended March 31, 2023 and 2022 respectively.
The stock-based compensation expenses for the three months ended March 31, 2023 and 2022 were recognized in the statements of operations as follows;
| For the three-month period ended | ||||||||
| March 31, 2023 | March 31, 2022 | |||||||
| US Dollars (In thousands) | ||||||||
| Research and development expenses | ||||||||
| Marketing expenses | ||||||||
| General and administrative expenses | ||||||||
| For the three-month period ended | ||||||||
| March 31, 2023 | March 31, 2022 | |||||||
| Dividend yields (see (I) below) | % | % | ||||||
| Share price (in U.S. dollar) (see (II) below) | ||||||||
| Expected volatility (see (III) below) | % - | % | % - | % | ||||
| Risk-free interest rates (see (IV) below) | % - | % | % - | % | ||||
| Expected life (in years) (see (V) below) | - | - | ||||||
| 9 |
Notes to the Interim Unaudited Condensed Consolidated Financial Statements
Note 4 - Stock options plan (Cont’d)
| I. |
| II. |
| III. |
| IV. |
| V. |
| 10 |
ITEM 2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
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 in Part I, Item 1A, of our Annual Report on Form 10-K for the fiscal year ended December 31, 2022 as filed with the Securities and Exchange Commission, or the SEC, on March 29, 2023. As used in this quarterly report, the terms “we”, “us”, “our”, the “Company” and “IR-Med” mean IR-Med, Inc.. and our wholly-owned subsidiary IR. Med Ltd. unless otherwise indicated or as otherwise required by the context.
Overview
IR-Med is a development stage medical device company that is developing non-invasive devices for various medical indications, by detecting and measuring various biomarkers and molecules in the blood and in human tissue in real-time, allowing healthcare professionals to detect and measure different molecules in the blood and in human tissue in real-time without any invasive procedures. Our initial product candidates are currently in various stages of development.
Our initial product under development, which we call PressureSafe, is a handheld optical monitoring device that is being developed to support early detection of pressure injuries (PI) to the skin and underlying tissue, regardless of skin tone and which calibrated personally to each patient’s skin, primarily caused by prolonged pressure associated with bed confinement. Our skin-device-interphase development of personalized medical devices allows high accuracy readings from the human body in a non-invasive method, that may provide caregiver the optimal decision support-system in cases where uncertainties disturb physicians in their decision processes. We plan to launch as a decision support system (DSS) tool for care givers in Hospitals, Nursing homes and Home-Care companies,
We are also in the preliminary stage of research and development of an innovative otoscope, which we call Nobiotics, to support physicians with an immediate indication as to whether mid-ear infection (Otitis Media), a common malady in children, is of a bacterial origin and thus requiring antibiotic treatment, or of a viral origin and does not require antibiotic treatment.
Our technology platform utilizes Artificial Intelligence (AI). 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.
The global diagnostics market is driven in large part by solutions that can be applied in 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 offering additional Decision Support Systems (DSS) tools may improve diagnoses and outcomes through the adoption of AI-based decision support tools.
| 11 |
Our initial focus is on the development of DSS solutions utilizing our proprietary platform for the pre-emptive diagnosis of pressure injuries (PI) and of mid-ear infections detection. Our current business plan focuses on two principal medical devices currently in development:
1. PressureSafe — a handheld optical monitoring device that is being developed to support early detection of pressure injuries (PI) to the skin and underlying tissue, primarily caused by prolonged pressure associated with bed confinement; and
2. Nobiotics, an innovative otoscope, being designed to support physicians with an immediate indication as to whether mid-ear infection (Otitis Media), a common malady in children, is of a bacterial origin and thus requiring antibiotic treatment, or of a viral origin and does not require antibiotic treatment.
Our product candidates are in various stages of development. The PressureSafe device is in an advanced stage of development and is planned to be our first go-to-market product, and the NoBiotics is in initial stage of research and development.
We have completed the development of the first generation PressureSafe prototype in the second quarter of 2022. In June 2022, IR Med. Ltd., our wholly owned subsidiary, entered into a study agreement with Beit Rivka, a Large Geriatric Hospital in Israel associated with Clalit, the largest Health Maintenance Organization (HMO) in Israel, to conduct a usability study of Pressuresafe. In August 2022, IR Med. Ltd., entered into an agreement with an Israeli boutique industrial design company specializing in the design of medical devices and diagnostic products servicing a broad array of companies, including large multinational companies, for the design of the PressureSafe device in its advanced configuration, which incorporates preliminary results from a usability study currently being performed in Israel, including feedback from healthcare professionals. In February 2023, our subsidiary IR-Med Ltd. entered into an agreement with Rabin Medical Center (RMC) in Israel to perform a usability study, as an additional study center to the current study that we have been performing at Beit-Rivka, a large geriatrics hospital in Israel. The agreement is to conduct a usability study of our proprietary and patent protected “PressureSafe” device, which we plan to launch as a decision support system (DSS) tool for care givers in Hospitals, Nursing homes and Home-Care companies.
We are currently working on completing the development of the commercial version of the PressureSafe device, planned to be launched during 2023, pending FDA clearance.
Distribution Agreement
In the third quarter of 2022, we began preparations in anticipation of commercialization of PressureSafe in the United States pending regulatory approvals. On October 7, 2022, IR. Med, Ltd. and PI Prevention Care LLC, a Delaware limited liability company (the “Distributor”) entered into an exclusive Distribution and License Agreement (the “Distribution Agreement”) pursuant to which the Distributor received exclusive royalty bearing rights to promote, market and sell solely in the United States our PressureSafe monitoring device.
The Distributor is a recently formed Delaware entity comprised of persons and other entities including Company shareholders, who are active in the markets relating to senior care facilities, hospitals, home care centers, hospital equipment distributors, among others, throughout the United States and who are familiar with and have wide experience in addressing and responding to the needs of these medical care organizations.
Under the Distribution Agreement, the Distributor is solely responsible for the distribution, marketing and sales of the PressureSafe and its accompanying components and agreed undertake all commercially reasonable efforts to establish the necessary distribution and sales network for the Products by not later than the date on which the Company shall have received all regulatory and other clearance required to launch the commercialization of the PressureSafe Solution (such Date being the “Commercial Launch Date”). Prior to the Commercial Launch Date, the Distributor is to invest such resources as is reasonable such that upon the occurrence of the Commercial Launch Date there will be a commercially reasonable distribution network in place for the immediate marketing of the Product.
| 12 |
The Distribution Agreement provides for the payment of annual licensing fees. The Distribution Agreement also specifies the prices of each component of the Products payable to the Company and also provides for minimum annual purchase requirements of Product components in order to maintain exclusivity. If for whatever reason the Distributor does not comply with the minimum purchase requirements in any year, the Distributor can continue to have a non-exclusive license and distribution rights in the United States if the Distributor pays the annual license fee.
Subject to the compliance by the Distributor of its obligation under the Distribution Agreement, including the purchase by the Distributor of minimum annual purchase requirements of the components of the Products, the Distribution Agreement continues in effect for a term of thirteen years following the Commercial Launch Date. At the end of the initial three and eight year period, the parties are to enter into good faith negotiations as to the pricing of the Products and the minimum purchase quantities for the subsequent period. The Distributor also agreed to not distribute any products that compete with the Products.
Distribution and Revenue Generation
We intend to establish sales and marketing structures and strategic partnerships in the United States, UK and in Europe to support all of our product candidates.
The target markets for our PressureSafe device are relevant Health care setting (i.e., hospitals, senior care facilities, home care companies etc.), nursing homes and a growing segment of long terms home care givers. Towards that end, in third quarter of 2022, we began preparations in anticipation of commercialization of PressureSafe in the United States during 2023, pending regulatory approvals.
Once we receive the appropriate sales approvals, we expect the marketing will be done with local partners who have the relevant abilities and connections per each territory the company will ask to sell the products at. Since each country has its own specific healthcare system, a local partner (one or more) will be chosen to address the specific market needs- in terms of regulation, technical support and so on. Pricing will be determined by the local partner, taking in account all overhead expected costs, regulation requirements and reimbursement methods.
Nobiotics’ target users will be pediatricians, family doctors and Ear, Nose and Throat (ENT) doctors. The distribution of the Nobiotics is expected to be carried out by companies who are suppling devices and disposables to the target audience.
In both the PressureSafe and the Nobiotics devices, the revenue stream is expected to be generated mainly from the disposables and PSaaS (PressureSafe solution as a service) that are needed for the proper operation of the device, while the device itself likely be given under lease agreements. It is envisioned that the disposable component will be mass produced.
It is expected that market penetration for Nobiotics will be achieved through OEM agreements with one of several large medical device companies, already selling to the target market. At the current time, we have no commitments from any such distributors or OEM partners.
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. Our current development plans focus on the development of our PressureSafe and Nobiotics diagnostic devices. The design and development of these devices will consume a large proportion of our current, as well as projected, resources.
| 13 |
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 preclinical testing, manufacturing and related testing and clinical trial activities.
Marketing
Marketing expenses consist primarily of salaries, employee benefits, equity compensation, and other personnel-related costs associated with executive and other support staff. Other significant marketing expenses include the costs associated with professional fees to develop our marketing strategy.
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.
Results of Operations
Comparison of the Three Months Ended March 31, 2023 to the Three Months Ended March 31, 2022
For the three months ended March 31, | ||||||||
| 2023 | 2022 | |||||||
| U.S dollars (in thousands) | ||||||||
| Research and development expenses | 605 | 477 | ||||||
| Marketing expenses | 172 | 51 | ||||||
| General and administrative expenses | 575 | 325 | ||||||
| Total operating expenses | 1,352 | 853 | ||||||
| Financial income, net | (2 | ) | (4 | ) | ||||
| Loss for the period | 1,350 | 849 | ||||||
Revenues. During the three-month period ended March 31, 2023 and 2022, we did not recorded any revenues from operation.
| 14 |
Research and Development Expenses- Research and development expenses consist of salaries and related expenses, consulting fees, service providers’, costs, and overhead expenses. Research and development expenses increased from $ 477,000 during the three months ended March 31, 2022 to $605,000 during the corresponding three month period in 2023. The increase in 2023 period resulted primarily from the recruitment of employees, increased use of third party contractors for further research and development activities, the performance of usability studies for our PressureSafe device and non-cash expenses recorded respecting stock based compensation to employees and service providers.
Marketing Expenses – Marketing expenses consist primarily of salaries and professional services. Marketing expenses increased from $51,000 during the three months ended March 31, 2022 to $172,000 during the corresponding three month period in 2023. The increase in marketing expenses resulted primarily from non-cash expenses attributable to stock-based compensation to service providers.
General and Administrative Expenses. General and administrative expenses consist primarily of salaries and related expenses and other non-personnel related expenses such as legal and accounting related expenses. General and Administrative expense increased from $325,000 during the three months ended March 31, 2022 to $575,000 in the corresponding three-months period in 2023. The increase in general and administrative expenses
resulted primarily from non-cash expenses attributable to stock-based compensation to our directors, officers and service providers.
Loss. Loss for the three months ended March 31, 2023 was $1,350,000 compared to $849,000 for the corresponding three month period in 2023. The increase in net loss is primarily attributable to non-cash expenses attributable to stock-based compensation to directors, officers and service providers, utilization of third party contractors for further research and development activities and the conduct of usability studies for our PressureSafe device.
Financial Condition, Liquidity and Capital Resources
We are subject to risks common to companies in the medical device industry, including but not limited to, the need for additional capital, the need to obtain marketing approval and reimbursement for any product candidate that we may identify and develop, the need to successfully commercialize and gain market acceptance of our product candidates, dependence on key personnel, protection of proprietary technology, compliance with government regulations, development of technological innovations by competitors, reliance on third-party manufacturers and the ability to transition from pilot-scale production to large-scale manufacturing of products.
From inception, we have funded our operations from a combination of loans and sales of equity instruments. In 2021 and 2022, we raised aggregate gross proceeds of $5,830,000 and $3,625,000, respectively, from sales of our equity and equity linked securities.
As of March 31, 2023, we had $2,103,000 in cash resources and approximately $653,000 of liabilities, including of $627,000 of current liabilities from operations.
The following table provides a summary of operating, investing, and financing cash flows for the three months ended March 31, 2023 (in thousands):
| For the three months ended | ||||||||
| March 31, 2023 | March 31, 2022 | |||||||
| US Dollars (In thousands) | ||||||||
| Net cash used in operating activities | (900 | ) | (754 | ) | ||||
| Net cash used in investing activities | - | (20 | ) | |||||
We have experienced operating losses since inception and had a total accumulated deficit of $11,280,000 as of March 31, 2023. We expect to incur additional costs and will require additional capital to realize our business plans. These losses have resulted in significant cash used in operations. During the three months ended March 31, 2023 and 2022, our cash used in operations was approximately $900,000 and $754,000, respectively. We need to continue and intensify 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.
| 15 |
We need to obtain additional funding in order to pursue our business plans. If we are unable to raise capital when needed or on attractive terms, we would be forced to delay, reduce or eliminate our research and development programs or future commercialization efforts.
We expect that our existing cash and cash equivalents will enable us to fund our operations and capital expenditure requirements through the fourth quarter of 2023. 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 the PressureSafe and Nobiotics 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. |
For the three months ended March 31, 2023 and as of the date of this report, we assessed our financial condition and concluded that based on our current and projected cash resources and commitments, as well as other factors mentioned above, there is a substantial doubt about our ability to continue as a going concern. We are planning to raise additional capital to continue our operations, as well as to explore additional avenues to increase revenues and reduce expenditures. 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.
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 favorable 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.
Off-Balance Sheet Arrangements
We do not have any off-balance sheet arrangements.
ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
A smaller reporting company, as defined by § 229.10(f)(1), is not required to provide the information required by this Item.
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ITEM 4. CONTROLS AND PROCEDURES
Evaluation of Disclosure Controls and Procedures
As of March 31, 2023, we conducted an evaluation under the supervision and with the participation of our management, including our Chief Executive Officer and Chief Financial Officer, regarding the effectiveness of the design and operation of our disclosure controls and procedures as defined in Rule 13a-15(e) and 15d-15(e) of the Securities Exchange Act of 1934 (the “Exchange Act”). The term “disclosure controls and procedures” means controls and other procedures of a company that are designed to ensure that information required to be disclosed by the company in reports that it files or submits under the Exchange Act is recorded, processed, summarized and reported within the requisite time periods and that such disclosure controls and procedures were effective to ensure that information required to be disclosed by the company in the reports that it files or submits under the Exchange Act is accumulated and communicated to its management, including its principal executive and principal accounting officers, or persons performing similar functions, as appropriate to allow timely decisions regarding required disclosure. Based on the evaluation of our disclosure controls and procedures as of March 31, 2023, our principal executive officer and principal financial officer concluded that, as of such date, our disclosure controls and procedures were effective at reasonable assurance level, as further described below.
Management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving their objectives and management necessarily applies its judgment in evaluating the cost-benefit relationship of possible controls and procedures. A material weakness is a deficiency, or a combination of deficiencies, in internal control over financial reporting, such that there is a reasonable possibility that a material misstatement of the company’s annual or interim financial statements will not be prevented or detected on a timely basis.
Changes in Internal Control Over Financial Reporting
During the quarter ended March 31, 2023, there were no changes in our internal control over financial reporting that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
PART II—OTHER INFORMATION
ITEM 1. LEGAL PROCEEDINGS
The Company is not currently involved in any legal proceedings. However, from time to time we may become involved in various legal proceedings that arise in the ordinary course of business, including actions related to our intellectual property. Although the outcomes of these legal proceedings cannot be predicted with certainty, we are currently not aware of any such legal proceedings that arise in the ordinary course of business, including actions related to our intellectual property. Although the outcomes of these legal proceedings cannot be predicted with certainty, we are currently not aware of any such legal proceedings or claims that we believe, either individually or in the aggregate, will have a material adverse effect on our business, financial condition, or results of operations.
ITEM 1A. RISK FACTORS
An investment in the Company’s Common Stock involves a number of very significant risks. You should carefully consider the risk factors included in the “Risk Factors” section of our Annual Report on Form 10-K for the year ended December 31, 2022, as filed with the SEC on March 29, 2023, in addition to other information contained in our reports and in this quarterly report in evaluating the Company and its business before purchasing shares of our Common Stock. There have been no material changes to our risk factors contained in our Annual Report on Form 10-K for the year ended December 31, 2022.
ITEM 2. UNREGISTERED SALES OF SECURITIES AND USE OF PROCEEDS
N/A
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ITEM 3. DEFAULTS UPON SENIOR SECURITIES
None.
ITEM 4. MINE SAFETY DISCLOSURES
N/A
ITEM 5. OTHER INFORMATION:
None
ITEM 6. EXHIBITS
Exhibit Index:
*** Portion of the Exhibit have been omitted.
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
IR-Med, Inc.
(Registrant)
| By: | /s/ Moshe Gerber | By: | /s/ Sharon Levkoviz | |
| Moshe Gerber | Sharon Levkoviz | |||
| Chief Executive Officer | Chief Financial Officer | |||
| (Principal Executive Officer) | (Principal Financial and Accounting Officer) | |||
| Date: | May 15, 2023 | Date: | May 15, 2023 |
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