HELIUS MEDICAL TECHNOLOGIES INC
For the period ended Jun 30, 2024. Filed Aug 12, 2024.
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A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Jun 30, 2024 · Filed Aug 12, 2024
HSDT$1.930.0%Stored close · as of Nov 6, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2024-03-31; filed 2024-05-13.
0001558370-24-007971
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2024-06-30; filed 2024-08-12.
0001558370-24-011905
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
Compared 67 previous paragraphs and 94 current paragraphs.
42 unchanged; 20 reworded; 22 added; 3 removed; 2 previous and 10 current paragraphs rearranged.
Tables are not compared: 3 previous and 4 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
Added paragraphs (22)
Current report
On August 9, 2024, we received written notice (the “Notification Letter”) from The Nasdaq Stock Market LLC (“Nasdaq”) notifying us that the Company was not in compliance with the minimum bid price requirements set forth in Nasdaq Listing Rule 5550(a)(2) for continued listing on the Nasdaq Capital Market. Nasdaq Listing Rule 5550(a)(2) requires listed securities maintain a minimum closing bid price of $1.00 per share, and Nasdaq Listing Rule 5810(c)(3)(A) provides that a failure to meet the minimum closing bid price requirement exists if the deficiency continues for a period of 30 consecutive business days. Based on the closing bid price of the Company’s Class A common stock (“Common Stock”) for the 30 consecutive business days prior to the date of the Notification Letter, the Company did not meet the minimum closing bid price requirement. To regain compliance, the closing bid price of the Company’s Common Stock must be at least $1.00 per share for a minimum of 10 consecutive business days at any time prior to February 5, 2025. There can be no assurance that we will be able to regain compliance with the minimum bid price requirement and other Nasdaq listing criteria. If we fail to meet the applicable continued listing requirements for the Nasdaq Capital Market, Nasdaq may delist our Common Stock. If such delisting should occur, it would likely have a negative effect on the price of our Common Stock and would impair an investor’s ability to sell or purchase our Common Stock when desired. In the event of a delisting, we can provide no assurance that any action taken by us to restore compliance with listing requirements would allow our Common Stock to become listed again, stabilize the market price or improve the liquidity of our Common Stock, prevent our Common Stock from dropping below the Nasdaq minimum bid price requirement, or prevent future non-compliance with Nasdaq’s listing requirements. Additionally, Nasdaq rules allow an expedited delisting of securities of companies that have had one or more reverse stock splits with a cumulative ratio of one for 250 or more shares over the prior two-year period. Under these rules, if a company falls out of compliance with the $1.00 minimum bid price after completing reverse stock splits over the immediately preceding two years that cumulatively result in a ratio one for 250 shares, the company will not be able to avail itself of any compliance periods and Nasdaq will instead require the issuance of a Staff delisting determination, which is appealable to a hearings panel. Our ability to remain listed on the Nasdaq Capital Market may be negatively impacted by this Nasdaq rule.
Current report
During the second quarter of 2024, the Company received the first third-party reimbursement from a major insurance carrier at a 7% rebate, which results in pricing of $23,900 for the PoNS device, comprised of $16,554 for the PoNS controller and $7,347 for the PoNS mouthpiece, exclusive of rounding.
Current report
In June 2024, the Company began establishing sales representative agreements with organizations and individuals to sell PoNS devices to Veterans Affairs (“VA”) facilities in the U.S. The Company has since established agreements with representatives covering facilities in 13 states and Puerto Rico.
Current report
The cost of revenue decrease for the three months ended June 30, 2024 was primarily attributable to lower sales compared to the same period in the prior year.
Current report
Gross Profit
Current report
The increase in research and development expenses was driven primarily by an increase in clinical trial activities for stroke and risk of fall programs.
Current report
Six Months Ended June 30, 2024 compared to the Six Months Ended June 30, 2023
Current report
Revenue
Current report
The decrease in net product sales for the six months ended June 30, 2024 as compared to the same period in the prior year was primarily attributable to decreased U.S. sales of PoNS systems after the termination of PTAP on June 30, 2023 and the temporary cash pay pricing in May 2024.
Current report
Cost of Revenue
Current report
The cost of revenue decrease for the six months ended June 30, 2024 was primarily attributable to lower sales compared to the same period in the prior year.
Current report
Gross Profit
Current report
Gross profit for the six months ended June 30, 2024 was $76 thousand compared to $61 thousand for the same period in the prior year. The increase was primarily attributable to increased margin on U.S. sales of PoNS systems after the termination of PTAP on June 30, 2023.
Current report
Selling, General and Administrative Expense
Current report
The decrease in selling, general and administrative expenses in the six months ended June 30, 2024 as compared to the same period in prior year was primarily attributable to higher professional fees mostly related to securities filings in the prior year period.
Current report
Research and Development Expense
Current report
The increase in research and development expenses year-to-year was primarily comprised ofclinical trial activities for stroke and risk of fall programs.
Current report
Amortization Expense
Current report
Nonoperating income (expense)
Current report
Interest Income (Expense), Net
Current report
Foreign Exchange Loss
Current report
Other Income, Net
Removed paragraphs (3)
Previous report
Gross Profit (Loss)
Previous report
The decrease in selling, general and administrative expenses in the first quarter of 2024 as compared to 2023 resulted primarily from a $0.4 million decrease in professional fees and payroll related expenses, partially offset by a $0.1 million increase in contract manufacturer expense associated with the transition to the new contract manufacturer during the current year period.
Previous report
The decrease in research and development expenses was driven primarily by a decrease in product development expenses and clinical trial activities as we transitioned our focus from product development and clinical trials to U.S. commercialization activities.
Reworded paragraphs (20)
Previous wording
This Quarterly Report on Form 10-Q contains forward-looking statements that involve risks and uncertainties, including statements regarding the Company’s market, strategy, competition, capital needs, business plans and expectations. Any statements contained herein that are not statements of historical facts may be deemed to be forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as “may”, “will”, “should”, “expect”, “plan”, “intend”, “anticipate”, “believe”, “estimate”, “predict”, “potential” or “continue”, the negative of such terms or other comparable terminology. Forward-looking statements are made, without limitation, in relation to the Company’s future growth and operational progress including expected enrollment, receipt of prescriptions and progress of commercialization of the PoNS device in the U.S., the impacts of the current global macroeconomic environment on the Company, the issuance by the Centers for Medicare & Medicaid Services (“CMS”) of rules regarding coverage of emerging technologies, clinical development plans, product development activities, the safety and effectiveness of the Company’s product, the manufacturing plans for the Company’s product, sufficiency of cash and availability of funds, and operating costs. Such forward-looking statements involve risks and uncertainties, known and unknown, including capital requirements to achieve the Company’s business objectives, the impact on the Company of global macroeconomic conditions including effects from supply chain constraints, logistics challenges, labor shortages, disruptions in the banking system and financial markets, high levels of inflation and increased interest rates on the Company’s ability to operate its business and access capital markets, the success of the Company’s business plan, including the Company’s ability to secure contracts with rehabilitation clinics, obtain national Medicare coverage and a reimbursement code so that the PoNS device is covered by Medicare and Medicaid, to build internal commercial infrastructure, secure state distribution licenses, build a commercial team and build relationships with Key Opinion Leaders, neurology experts and neurorehabilitation centers, market awareness of the PoNS device, availability of funds, manufacturing, the Company’s ability to maintain and enforce its intellectual property rights, clinical trials and the clinical development process, the product development process, the regulatory submission review and approval process, the Company’s operating costs and use of cash, and the Company’s ability to achieve significant revenues and other factors discussed in the section entitled “Item 1A. Risk Factors” in our 2023 10-K and those described from time to time in the Company’s future reports filed with the SEC. While these forward-looking statements, and any assumptions upon which they are based, are made in good faith, based on information available to the Company as…
Excerpt shortened here; the source contains the full paragraph.
Current wording
This Quarterly Report on Form 10-Q contains forward-looking statements that involve risks and uncertainties, including statements regarding the Company’s market, strategy, competition, capital needs, business plans and expectations. Any statements contained herein that are not statements of historical facts may be deemed to be forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as “may”, “will”, “should”, “expect”, “plan”, “intend”, “anticipate”, “believe”, “estimate”, “predict”, “potential” or “continue”, the negative of such terms or other comparable terminology. Forward-looking statements are made, without limitation, in relation to the Company’s future growth and operational progress including expected enrollment, receipt of prescriptions and progress of commercialization of the PoNS device in the U.S., the impacts of the current global macroeconomic environment on the Company, the issuance by the Centers for Medicare & Medicaid Services (“CMS”) of rules regarding coverage of emerging technologies, clinical development plans, product development activities, the safety and effectiveness of the Company’s product, the manufacturing plans for the Company’s product, sufficiency of cash and availability of funds and operating costs and our ability to continue as a going concern and future liquidity. Such forward-looking statements involve risks and uncertainties, known and unknown, including capital requirements to achieve the Company’s business objectives, the impact on the Company of global macroeconomic conditions including effects from supply chain constraints, logistics challenges, labor shortages, disruptions in the banking system and financial markets, high levels of inflation and increased interest rates on the Company’s ability to operate its business and access capital markets, the success of the Company’s business plan, including the Company’s ability to secure contracts with rehabilitation clinics, obtain national Medicare coverage and a reimbursement code so that the PoNS device is covered by Medicare and Medicaid, to build internal commercial infrastructure, secure state distribution licenses, build a commercial team and build relationships with Key Opinion Leaders, neurology experts and neurorehabilitation centers, market awareness of the PoNS device, availability of funds, manufacturing, the Company’s ability to maintain and enforce its intellectual property rights, clinical trials and the clinical development process, the product development process, the regulatory submission review and approval process, the Company’s operating costs and use of cash, and the Company’s ability to achieve significant revenues and other factors discussed in the section entitled “Item 1A. Risk Factors” in our 2023 10-K and those described from time to time in the Company’s future reports filed with the SEC. While these forward-looking statements, and any assumptions upon which they are based, are m…
Excerpt shortened here; the source contains the full paragraph.
Previous wording
As discussed further in Note 6 to our unaudited condensed consolidated financial statements, in May 2024, the Company closed on a public offering of its Class A common stock (“Common Stock”) and warrants and received net proceeds of approximately 5.6 million.
Current wording
As discussed further in Note 6 to our unaudited condensed consolidated financial statements, in May 2024, the Company closed on a registered public offering of its Common Stock and warrants and received net proceeds of approximately $5.5 million.
Previous wording
On April 4, 2024, the Company received written notice from the Nasdaq Stock Market LLC (“Nasdaq”) stating that the Company no longer complies with the minimum stockholders’ equity requirement under Nasdaq Listing Rule 5550(b)(1) for continued listing on The Nasdaq Stock Market LLC because the Company’s stockholders' equity, as reported in our 2023 10-K, has fallen below $2.5 million. The notice also indicates that the Company does not meet the alternative compliance standards. Under applicable Nasdaq rules, the Company has 45 calendar days from the date of the notice, or until May 20, 2024, to submit a plan to regain compliance. The Company intends to timely submit such a plan to Nasdaq. If the Company’s plan is accepted, Nasdaq may grant the Company an extension of up to 180 calendar days from the date of the notice to evidence compliance. The notice has no immediate impact on the listing of the Company’s Common Stock, which will continue to trade on The Nasdaq Stock Market LLC under the symbol “HSDT”.
Current wording
Stock Market LLC because the Company’s stockholders' equity, as reported in our 2023 10-K, had fallen below $2.5 million. The notice also indicated that the Company did not meet the alternative compliance standards. Under applicable Nasdaq rules, the Company had 45 calendar days from the date of the notice, or until May 20, 2024, to submit a plan to regain compliance. On May 31, 2024, the Company received formal notification from Nasdaq confirming that, following the consummation of a registered public offering on May 9, 2024, the Company regained compliance with the minimum stockholders’ equity requirement, and that the Company satisfies all other applicable criteria for continued listing on The Nasdaq Capital Market.
Previous wording
During the first quarter of 2024, the Company partnered with Lovell Government Services (“Lovell”), an SBA-certified Service-Disabled Veteran-Owned Small Business (“SDVOSB”), to make the PoNS device available to federal healthcare systems.
Current wording
During the first quarter of 2024, the Company partnered with Lovell Government Services (“Lovell”), an SBA-certified Service-Disabled Veteran-Owned Small Business (“SDVOSB”), to make the PoNS device available to federal healthcare systems. In May 2024, PoNS became available on the Veteran Affairs Federal Supply Schedule and General Services Administration Advantage Contracts at $23,843.72 for the PoNS device and $7,344.97 for the PoNS mouthpiece. In July 2024, PoNS became available to the Department of Defense and U.S. Military facilities on the Distribution and Pricing Agreement (“DAPA”) at $23,724.50 for the PoNS device and $7,308.25 for the PoNS mouthpiece.
Previous wording
On May 2, 2024, CMS published a proposed fee schedule payment rates for the PoNS Controller and PoNS Mouthpiece to be discussed at CMS' bi-annual Healthcare Common Procedure Coding System (“HCPCS”) public meeting to be held on May 29, 2024. For the PoNS Controller (HCPCS Code A4593), CMS preliminarily set pricing by mapping reimbursement to existing code E0745, (Neuromuscular stimulator, electronic shock unit), resulting in a capped fee of $1,206.53. For the PoNS Mouthpiece (HCPCS code A4594), CMS based pricing on the cash pay price of $4,500, resulting in a total capped payment of $3,075.53.
Current wording
Presently, PoNS Therapy is not covered by CMS or reimbursed under contract by any third-party payers in the U.S. We are pursuing commercial insurance coverage and Medicare reimbursement for PoNS within the Durable Medical Equipment (“DME”) benefit category. On February 29, 2024, CMS assigned HCPCS Level II codes to the PoNS controller and PoNS mouthpiece, effective April 1, 2024. On May 2, 2024, CMS published a proposed fee schedule payment rates for the PoNS controller and PoNS mouthpiece to be discussed at CMS' bi-annual Healthcare Common Procedure Coding System (“HCPCS”) public meeting to be held on May 29, 2024. For the PoNS Controller (HCPCS Code A4593), CMS preliminarily set pricing by mapping reimbursement to existing code E0745, (Neuromuscular stimulator, electronic shock unit), resulting in a capped fee of $1,206.53. For the PoNS Mouthpiece (HCPCS code A4594), CMS based pricing on the previously offered, temporary, cash pay price of $4,500, resulting in a total capped payment of $3,075.53.
Previous wording
On February 29, 2024, CMS assigned HCPCS Level II codes to the PoNS controller and PoNS mouthpiece, effective April 1, 2024. The Company has since provided CMS additional information to support reimbursement economics ahead of the public meetings expected in late May 2024 for consideration by CMS for determination of a reimbursement amount for each of the PoNS controller and mouthpiece in our efforts to secure reimbursement by CMS to be effective October 1, 2024.
Current wording
The Company subsequently provided CMS additional information to support reimbursement economics and presented that information at the public meeting with CMS on May 29, 2024 for consideration by CMS for determination of the final reimbursement amount for each of the PoNS controller and mouthpiece. The Company expects that CMS will publish final reimbursement amounts in late August or early September to be effective October 1, 2024.
Previous wording
During the first quarter of 2024, the Company reached alignment with the FDA on the stroke program that consists of two studies a clinical trial of PoNS Therapy in stroke participants in collaboration with Medical University of South Carolina that commenced in 2023 and an open label study to evaluate the therapeutic benefit of PoNS in chronic stroke subjects started enrolling participants in the first quarter of 2024 in three sites in the U.S. and Canada as part of our registrational program for gait and balance deficit due to stroke. Enrollment for both studies is expected to be completed by the end of 2024 with a submission to FDA targeted for mid-to-late 2025.
Current wording
During the first quarter of 2024, the Company reached alignment with the FDA on a registrational program to evaluate the therapeutic benefit of PoNS on gait and balance deficits in chronic stroke subjects that consists of an investigator initiated clinical trial in collaboration with Medical University of South Carolina, which commenced in 2023 and is currently enrolling participants at two US sites, and a company-sponsored open label study, currently ongoing and, since the first quarter of 2024, enrolling participants at five additional US sites. To support national reimbursement in Canada, Helius has begun an additional study on the use of PoNS Therapy to treat stroke targeting enrollment of 40 to 60 subjects by the end of 2024 at three Canadian centers of excellence for stroke rehabilitation. The sites have started enrollment in July and the results from this study will be part of the data package submission to obtain FDA authorization for stroke in the United States. Enrollment for the registrational program is expected to be completed by the end of 2024 with a submission to FDA targeted for mid-to-late 2025. An outcome research program to assess the effect of on-label PoNS Therapy on the risk of falling in subjects with gait and balance deficit due to stroke, traumatic brain injury, and multiple sclerosis is ongoing in Canada with results expected by the end of 2024.
Previous wording
We also intend to provide broad access and reimbursement for the PoNS Therapy over time through commercial insurers. Prior to the initiation of CMS or broad commercial payer coverage, we anticipate the primary source of sales will be self-pay patients. We expect to support the cost of the PoNS Therapy by offering a cash pay discount, collaborating with third parties to provide self-pay patients with financing options as well as working with advocacy groups and charitable organizations to help self-pay patients access our technology. In general, we anticipate that it will take at least 24 months to obtain broad coverage and reimbursement among government and private payers once the HCPCS codes become effective.
Current wording
We also intend to provide broad access and reimbursement for the PoNS Therapy over time through commercial insurers. Prior to the initiation of CMS or broad commercial payer coverage, we anticipate the primary source of sales will be self-pay and VA patients. We expect to support the cost of the PoNS Therapy by working with advocacy groups and charitable organizations to help self-pay patients access our technology. In general, we anticipate that it will take at least 24 months to obtain broad coverage and reimbursement among government and private payers from the date that the HCPCS codes became effective.
Previous wording
Net product sales for the three months ended March 31, 2024 were comparable to the same period in the prior year.
Current wording
The decrease in net product sales for the three months ended June 30, 2024 as compared to the same period in the prior year was primarily attributable to a decrease in U.S. sales of PoNS systems after the termination of our Patient Therapy Access Program (“PTAP”) on June 30, 2023 as well as the termination of the previously offered temporary cash pay pricing in May 2024.
Previous wording
Gross profit for the three months ended March 31, 2024 was $12 thousand compared to gross loss of $11 thousand for the same period in the prior year. The increase was primarily a result of a decrease in inventory reserve and an increase in other revenue.
Current wording
Gross profit for the three months ended June 30, 2024 was $64 thousand compared to $72 thousand for the same period in the prior year. The decrease was primarily a result of an increase in fixed overhead costs, which were primarily comprised of salaries and benefits of employees involved in management of the supply chain.
Previous wording
The cost of revenue for the three months ended March 31, 2024 as compared with the same period in the prior year remained relatively flat year to year and is comprised of product costs from net product sales and fixed overhead costs.
Current wording
The selling, general and administrative expenses in the first quarter of 2024 as compared to the same period in prior year remained relatively flat year to year.
Previous wording
Net interest expense for the three months ended March 31, 2024 compared to net interest income in the prior year period resulted from lower balances earning interest income year to year, respectively, offset by interest expense related to lease commitments.
Current wording
Net interest expense for the three months ended June 30, 2024 compared to net interest income in the prior year period resulted from lower cash balances earning interest income year to year, respectively, offset by interest expense related to lease commitments.
Previous wording
As discussed in more detail in Note 6 to our Unaudited Condensed Consolidated Financial Statements, the warrants issued in connection with the public offering completed on August 9, 2022 are being accounted for as a derivative liability instrument. The gain on change in fair value of derivative liability for the three months ended March 31, 2024 of $1.1 million was primarily due to a decrease in our stock price.
Current wording
As discussed in more detail in Note 6 to our Unaudited Condensed Consolidated Financial Statements, the warrants issued in connection with the public offering completed on August 9, 2022 are being accounted for as a derivative liability instrument. The gain on change in fair value of derivative liability for the three months ended June 30, 2024 of $1.7 million was primarily due to a decrease in our stock price.
Previous wording
Our available capital resources have been primarily used to expand our U.S. commercialization efforts, fund manufacturing activities for the PoNS device, conduct clinical trials and for working capital and general corporate purposes. Our primary sources of cash and cash equivalents have been proceeds from public and private offerings of our Common Stock, which most recently included $16.3 million in net proceeds we received from a public offering of our Common Stock and warrants completed in August 2022 as discussed in more detail in Note 8 to our Consolidated Financial Statements included our 2023 10-K. As discussed in more detail in Note 6 to our Unaudited Condensed Consolidated Financial Statements, the Company entered into a sales agreement related to our at-the-market offering program (“ATM”) under which we may offer and sell shares having gross proceeds up to $2.0 million. During the three months ended March 31, 2024 the Company issued and sold shares with gross proceeds of $1.4 million under the ATM. As discussed in more detail in Note 6, the Company received gross proceeds of $0.2 million from the issuance of shares upon the exercise of warrants in the three months ended March 31, 2024.
Current wording
Our available capital resources have been primarily used to expand our U.S. commercialization efforts, fund manufacturing activities for the PoNS device, conduct clinical trials and for working capital and general corporate purposes. Our primary sources of cash and cash equivalents have been proceeds from public and private offerings of our Common Stock, which included $16.3 million in net proceeds we received from a public offering of our Common Stock and warrants completed in August 2022 as discussed in more detail in Note 8 to our Consolidated Financial Statements included our 2023 10-K. As discussed in more detail in Note 6 to our Unaudited Condensed Consolidated Financial Statements, the Company entered into a sales agreement related to our at-the-market offering program (“ATM”) under
Previous wording
The following table summarizes our cash flows for the three months ended March 31, 2024 and 2023 (in thousands):
Current wording
The following table summarizes our cash flows for the six months ended June 30, 2024 and 2023 (in thousands):
Previous wording
The lower level of cash used in operating activities in the three months ended March 31, 2024 primarily resulted from the decrease in selling, general and administrative expenses and research and development expenses as compared with the same period in the prior year.
Current wording
The lower level of cash used in operating activities in the six months ended June 30, 2024 primarily resulted from the decrease in selling, general and administrative expenses as compared with the same period in the prior year.
Previous wording
During the three months ended March 31, 2024, we received net proceeds of $1.3 million from the issuance and sale of shares under the ATM. In addition, we received $0.2 million in net proceeds from the exercise of warrants.
Current wording
During the six months ended June 30, 2024, we received net proceeds of $5.5 million from the issuance of Common Stock and warrants under the 2024 Public Offering, and $1.3 million from the issuance and sale of shares under the ATM. In addition, we received $0.2 million in net proceeds from the exercise of warrants.
Previous wording
31, 2024 and 2023. As of March 31, 2024, we had an accumulated deficit of $162.5 million. We expect to continue to incur significant expenses and operating losses for the foreseeable future. These and other factors indicate substantial doubt about our ability to continue as a going concern. Refer to Note 1 to our Unaudited Condensed Consolidated Financial Statements for additional discussion about our going concern uncertainty.
Current wording
Our ability to generate product revenues sufficient to achieve profitability will depend heavily on the successful commercialization of PoNS Therapy in the U.S. Our net loss was $4.1 million for each of the six months ended June 30, 2024 and 2023. As of June 30, 2024, we had an accumulated deficit of $164.1 million. We expect to continue to incur significant expenses and operating losses for the foreseeable future. These and other factors indicate substantial doubt about our ability to continue as a going concern. Refer to Note 1 to our Unaudited Condensed Consolidated Financial Statements for additional discussion about our going concern uncertainty.
Previous wording
We intend to use our available capital resources primarily to expand our U.S. commercialization efforts, fund manufacturing activities for the PoNS device, conduct clinical trials and for working capital and general corporate purposes. We believe that our existing capital resources, as well as the 5.6 million net proceeds from the issuance of Common Stock in May 2024 will be sufficient to fund our operations into 2025, but we will be required to seek additional funding through the sale of equity or debt financing to continue to fund our operations thereafter. We will need additional funding for our planned clinical trial for stroke. The amount required to fund operations thereafter will depend on various factors, including timing of approval of clinical trials, duration and result of clinical trials and other factors that affect the cost of the clinical trial, manufacturing costs of product, development of our product for new indications and demand for our authorized products in the market.
Current wording
We intend to use our available capital resources primarily to expand our U.S. commercialization efforts, fund manufacturing activities for the PoNS device, conduct clinical trials and for working capital and general corporate purposes. We believe that our existing capital resources, as well as the $5.5 million net proceeds from the issuance of Common Stock and warrants in May 2024 will be sufficient to fund our operations into 2025, but we will be required to seek additional funding through the sale of equity or debt financing to continue to fund our operations thereafter. We will need additional funding for our planned clinical trial for stroke. The amount required to fund operations thereafter will depend on various factors, including timing of approval of clinical trials, duration and result of clinical trials and other factors that affect the cost of the clinical trial, manufacturing costs of product, development of our product for new indications and demand for our authorized products in the market.
Previous wording
There can be no assurance that we will be successful in raising additional capital or that such capital, if available, will be on terms that are acceptable to us. If we are unable to raise sufficient additional capital, we may be compelled to reduce the scope of our operations and planned capital expenditure or sell certain assets, including intellectual property, and we may be forced to cease or wind down operations, seek protection under the provisions of the U.S. Bankruptcy Code, or liquidate and dissolve our company.
Current wording
There can be no assurance that we will be successful in raising additional capital or that such capital, if available, will be on terms that are acceptable to us. If we are unable to raise sufficient additional capital, we may be compelled to reduce the scope of our operations and planned capital expenditure or sell certain assets, including intellectual property, and we
Rearranged current paragraphs (10)
Current report — wording carried from elsewhere
On April 4, 2024, the Company received written notice from Nasdaq stating that the Company no longer complied with the minimum stockholders’ equity requirement under Nasdaq Listing Rule 5550(b)(1) for continued listing on The Nasdaq
Current report — wording carried from elsewhere
The following table summarizes our results of operations for the six months ended June 30, 2024 and 2023 (in thousands):
Current report — wording carried from elsewhere
Amortization expense was primarily comprised of the amortization of acquired finite-lived intangible assets. The change in amortization expense period over period is primarily due to certain intangible assets becoming fully amortized.
Current report — wording carried from elsewhere
Net interest expense for the six months ended June 30, 2024 compared to net interest income in the prior year period resulted from lower cash balances earning interest income year to year, respectively, offset by interest expense related to lease commitments.
Current report — wording carried from elsewhere
Change in Fair Value of Derivative Liability
Current report — wording carried from elsewhere
As discussed in more detail in Note 6 to our Unaudited Condensed Consolidated Financial Statements, the warrants issued in connection with the public offering completed on August 9, 2022 are being accounted for as a derivative liability instrument. The gain on change in fair value of derivative liability for the six months ended June 30, 2024 of $2.9 million was primarily due to a decrease in our stock price.
Current report — wording carried from elsewhere
The change in foreign exchange (loss) gain was primarily due to fluctuations in the Canadian to U.S. dollar exchange rates.
Current report — wording carried from elsewhere
Other income for the six months ended June 30, 2024 was primarily attributable to dividend income earned on investments of excess cash in money market mutual funds.
Current report — wording carried from elsewhere
which we may offer and sell shares having gross proceeds up to $2.0 million. During the six months ended June 30, 2024 the Company issued and sold shares with gross proceeds of $1.4 million under the ATM. As discussed in more detail in Note 6, the Company received gross proceeds of $0.2 million from the issuance of shares upon the exercise of warrants and a $5.5 million net proceeds from the 2024 Public Offering in the six months ended June 30, 2024.
Current report — wording carried from elsewhere
may be forced to cease or wind down operations, seek protection under the provisions of the U.S. Bankruptcy Code, or liquidate and dissolve our company.
Rearranged previous paragraphs (2)
Previous report — wording carried elsewhere
Presently, PoNS Therapy is not covered by CMS or reimbursed by any third-party payers in the U.S. We are pursuing commercial insurance coverage and Medicare reimbursement for PoNS within the Durable Medical Equipment, or DME, benefit category. We expect to interact again with CMS in late May 2024 to seek Medicare final payment determinations for both codes to be effective at the next scheduled date of October 1, 2024.
Previous report — wording carried elsewhere
Our ability to generate product revenues sufficient to achieve profitability will depend heavily on the successful commercialization of PoNS Therapy in the U.S. Our net loss was $2.5 million for each of the three months ended March