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KNOW LABS INC

For the period ended Jun 30, 2024. Filed Aug 14, 2024.

View on SEC.gov

About this filing

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 14, 2024

USBC$0.37+2.8%Stored close · as of Nov 6, 2026

What changed in Management’s Discussion and Analysis?

Read the current filing

Previous report: 10-Q

Period ended 2024-03-31; filed 2024-05-15.

0001654954-24-006410

ITEM 2. Management's Discussion and Analysis of Financial Condition and Results of Operations

Current report: 10-Q

Period ended 2024-06-30; filed 2024-08-14.

0001654954-24-010633

ITEM 2. Management's Discussion and Analysis of Financial Condition and Results of Operations

The 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 123 previous paragraphs and 120 current paragraphs.

87 unchanged; 27 reworded; 5 added; 9 removed; 0 previous and 1 current paragraphs rearranged.

Tables are not compared: 9 previous and 8 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 (5)

Current report

The other expense, net for the three months ended June 30, 2023 included (i) loss on disposal of assets of $384,000 related to the consolidation of leased offices; and offset by other income of $23,000.

Current report

Net Loss.** **Net loss for the three months ended June 30, 2024 was $4,103,000 as compared to $3,600,000 for the three months ended June 30, 2023. The net loss for the three months ended June 30, 2024 included non-cash expenses of $1,339,000. The non-cash items include (i) depreciation and amortization of $21,000; (ii) stock based compensation- stock options of $1,016,000;; (iii) amortization of operating lease right-of-use asset of $26,000; and (iv) interest expense for the extension of notes and warrants of $276,000.

Current report

The net loss for the three months ended June 30, 2023 included non-cash expenses of $1,005,000. The non-cash items include (i) depreciation and amortization of $54,000; (ii) stock based compensation- stock options of $567,000; and (iii) loss on disposal of assets of $384,000 related to the consolidation of leased offices.

Current report

The other expense, net for the nine months ended June 30, 2023 included (1) interest income of $114,000; offset by (ii) interest expense, net of $389,000; and (iii) loss on disposal of assets of $384,000 related to the consolidation of leased offices.

Current report

The net loss for the nine months ended June 30, 2023 included non-cash expenses of $3,553,000. The non-cash items include (i) depreciation and amortization of $259,000; (ii) loss on disposal of assets of $384,000 related to the consolidation of leased offices; (iii) modification of notes and warrants of $350,000; (ix) stock based compensation- stock options of $2,464,000; and (v) amortization of operating lease right-of-use asset of $96,000.
Removed paragraphs (9)

Previous report

On September 15, 2023, we signed amendments to the convertible promissory or OID notes, held by Clayton A. Struve and Ron Erickson, who also serves as our Chief Executive Officer, to extend the due dates to September 30, 2024.

Previous report

On September 29, 2023, we closed an offering of our common stock pursuant to which we sold 28,000,000 shares of common stock, at a purchase price of $0.25 per share. After deducting underwriting commissions and other offering expenses, we received net proceeds of $5,472,791. As part of the offering, we issued common stock purchase warrants to the underwriter representatives to purchase an aggregate of 1,960,000 shares of Common Stock at an exercise price of $0.25 per share, subject to adjustments. The warrants are immediately exercisable and may be exercised at any time and from time to time, in whole or in part, until September 26, 2028 and may be exercised on a cashless basis.

Previous report

On February 27, 2024, we (a) entered into a securities purchase agreement with the selling stockholder pursuant to which we may issue to the selling stockholder one or more senior convertible notes in the aggregate principal amount of up $14,400,000 for an aggregate purchase price equal to up to $12,000,000 and common stock purchase warrants and (b) issued a$4,800,000 Note and the Warrant to the selling stockholder in exchange for a purchase price of $4,000,000 and net proceeds of $3,805,699.

Previous report

The other expense, net for the three months ended March 31, 2023 included interest expense of $124,000.

Previous report

Net Loss.** **Net loss for the three months ended March 31, 2024 was $5,398,000 as compared to $4,930,000 for the three months ended March 31, 2023. The net loss for the three months ended March 31, 2024 included non-cash expenses of $976,000. The non-cash items include (i) depreciation and amortization of $20,000; (ii) stock based compensation- stock options of $617,000; (iii) issuance of common stock for services of $251,000; and (iv) amortization of operating lease right-of-use asset of $88,000.

Previous report

The net loss for the three months ended March 31, 2023 included non-cash expenses of $1,427,000. The non-cash items include (i) depreciation and amortization of $102,000; (ii) stock based compensation- stock options of $1,183,000; (iii) expenses for extension of notes, warrants and stock options of $143,000; and offset by (iv) other of $1,000.

Previous report

The other expense, net for the six months ended March 31, 2023 included interest expense of $299,000.

Previous report

The net loss for the six months ended March 31, 2023 included non-cash expenses of $2,479,000. The non-cash items include (i) depreciation and amortization of $205,000; (ii) stock based compensation- stock options of $1,927,000; (iii) expenses for extension of notes, warrants and stock options of $350,000; and offset by (iv) other of $3,000.
Reworded paragraphs (27)

Previous wording

On March 6, 2024, we announced interim results from our internal clinical research study, which assessed the accuracy of Know Labs’ proprietary radiofrequency (RF) dielectric sensor in non-invasively measuring blood glucose in participants with prediabetes and Type 2 diabetes using venous blood as a comparative reference – resulting in an overall Mean Absolute Relative Difference (MARD) of 11.1%. The ML model was trained to estimate reference venous blood glucose values on 80% of the data (520 paired values) randomly selected from measured values and then tested on the remaining, held out 20% (130 paired values), where a paired value is defined as data collected from the novel RF sensor paired with a single venous blood glucose value. This study has since been completed and represents an important step in our clinical development by using venous blood as a comparator, which will be required for future FDA clearance, and testing within the target population of the ultimate commercial product.

Current wording

On March 6, 2024, we announced interim results from our internal clinical research study, which assessed the accuracy of our proprietary radiofrequency (RF) dielectric sensor in non-invasively measuring blood glucose in participants with prediabetes and Type 2 diabetes using venous blood as a comparative reference – resulting in an overall Mean Absolute Relative Difference (MARD) of 11.1%. The ML model was trained to estimate reference venous blood glucose values on 80% of the data (520 paired values) randomly selected from measured values and then tested on the remaining, held out 20% (130 paired values), where a paired value is defined as data collected from the novel RF sensor paired with a single venous blood glucose value. This study has since been completed and represents an important step in our clinical development by using venous blood as a comparator, which will be required for future FDA clearance, and testing within the target population of the ultimate commercial product.

Previous wording

As the Company successfully completed its foundational studies, created a stable sensor that delivers repeatable results, and developed a software infrastructure to manage and interpret large, novel datasets, it will continue to expand its testing and data gathering with larger and more diverse populations. These new studies will help determine the need, if any, for individual calibration and will evaluate the technology’s performance throughout continuous wear, in more real-world environments, and within more expansive glycemic ranges, including the hypoglycemic range (<70 mg/dL). The Company’s data science and algorithm development efforts in 2024 include refining our algorithm to create personalized models, ensuring it is calibrated with blood glucose reference data from each individual using the KnowU and enabling an accurate glucose value estimation for a known population whenever the device is worn in the future. Building personalized models is an early step toward a generalized algorithm, but the ability to create these models may themselves prove to be viable in an FDA-cleared commercial device.

Current wording

As the Company successfully completed its foundational studies, created a stable sensor that delivers repeatable results, and developed a software infrastructure to manage and interpret large, novel datasets, it will continue to expand its testing and data gathering with larger and more diverse populations. These new studies will help determine the need, if any, for individual calibration and will evaluate the technology’s performance throughout continuous wear, in more real-world environments, and within more expansive glycemic ranges, including the hypoglycemic range (<70 mg/dL). Our data science and algorithm development efforts in 2024 include refining our algorithm to create personalized models, ensuring it is calibrated with blood glucose reference data from each individual using the KnowU and enabling an accurate glucose value estimation for a known population whenever the device is worn in the future. Building personalized models is an early step toward a generalized algorithm, but the ability to create these models may themselves prove to be viable in an FDA-cleared commercial device.

Previous wording

We group our competition into three large categories. Those are (i) large global technology companies who may enter the blood glucose monitoring and other medical diagnostic markets, (ii) legacy providers of blood glucose monitoring technology, and (iii) new entrants working to achieve a non-invasive solution or more acceptable blood glucose monitoring solutions which may or may not be similar to our technology. With regard to companies in each category, we perform due diligence from all publicly available sources of information on their relevant technologies and their product plans. This information informs and refines our activities and underscores our sense of urgency as we work to bring our own technology to the marketplace. As it relates to all competitors, we continue to focus on building the world’s most robust patent portfolio in this space. PatSnap Research and ipCapital Group, two leading patent analytic firms, have ranked Know Labs #1 for global patent leadership in non-invasive glucose monitoring patents. We have retained both organizations to perform patent related work. We continue to build out our patent portfolio and grow our trade secret AI and ML driven algorithms. Patents issued, pending, and in-process increased from 159 to 336 YoY (+109% vs. market +35%*) reflecting our high rate of innovation.

Current wording

We group our competition into three large categories. Those are (i) large global technology companies who may enter the blood glucose monitoring and other medical diagnostic markets, (ii) legacy providers of blood glucose monitoring technology, and (iii) new entrants working to achieve a non-invasive solution or more acceptable blood glucose monitoring solutions which may or may not be similar to our technology. With regard to companies in each category, we perform due diligence from all publicly available sources of information on their relevant technologies and their product plans. This information informs and refines our activities and underscores our sense of urgency as we work to bring our own technology to the marketplace. As it relates to all competitors, we continue to focus on building the world’s most robust patent portfolio in this space. PatSnap Research and ipCapital Group, two leading patent analytic firms, have ranked Know Labs #1 for global patent leadership in non-invasive glucose monitoring patents. We have retained both organizations to perform patent related work. We continue to build out our patent portfolio and grow our trade secret AI and ML driven algorithms. Patents issued, pending, and in-process increased from 159 to 336 year over year (+109% vs. market +35%*) reflecting our high rate of innovation.

Previous wording

The Know Labs non-invasive glucose monitor is the ‘Next generation” whether used in a continuous or as spot check screening manner.

Current wording

We believe that our non-invasive glucose monitor represents the “Next generation” whether used in a continuous or as spot check screening manner.

Previous wording

The current estimation of the size of the global population suffering from diabetes is estimated by the Internation Diabetes Federation to be 579 million. It is expected to reach 643 million by 2030 and 784 million by 2040. Currently, the leading CGM providers, Dexcom, Abbott and Medtronic have 100% of the market share of CGMs. Based upon latest available information from their regulatory filings they have penetrated less than 1% of the global addressable market. While competitive analysis is always an important part of our business strategy and thinking, the scope of the market provides room for a number of providers of accurate, less expensive and more sustainable technology.

Current wording

The current estimation of the size of the global population suffering from diabetes is estimated by the International Diabetes Federation to be 579 million. It is expected to reach 643 million by 2030 and 784 million by 2040. Currently, the leading CGM providers, Dexcom, Abbott and Medtronic have 100% of the market share of CGMs. Based upon latest available information from their regulatory filings they have penetrated less than 1% of the global addressable market. While competitive analysis is always an important part of our business strategy and thinking, the scope of the market provides room for a number of providers of accurate, less expensive and more sustainable technology.

Previous wording

Our current research and development efforts are primarily focused on improving our radio frequency spectroscopy technology for the monitoring of blood glucose. As part of this effort, we continuously perform clinical testing of our devices, and we conduct on-going laboratory testing to ensure that application methods are compatible with the end-user and regulatory requirements, and that they can be implemented in a cost-effective manner. Over time we plan to focus on extending the capacity of our sensor technology to identify new analytes and applications. Our current internal team along with outside consultants have considerable experience working with the application of our technologies. We engage third party experts as required to supplement our internal team. We incurred expenses of approximately $3,662,000 and $4,307,000 for the six months ended March 31, 2024 and 2023, respectively, on development activities.

Current wording

Our current research and development efforts are primarily focused on improving our radio frequency spectroscopy technology for the monitoring of blood glucose. As part of this effort, we continuously perform clinical testing of our devices, and we conduct on-going laboratory testing to ensure that application methods are compatible with the end-user and regulatory requirements, and that they can be implemented in a cost-effective manner. Over time, we plan to focus on extending the capacity of our sensor technology to identify new analytes and applications. Our current internal team along with outside consultants have considerable experience working with the application of our technologies. We engage third party experts as required to supplement our internal team. We incurred expenses of approximately $5,011,000 and $6,186,000 for the nine months ended June 30, 2024 and 2023, respectively, on development activities.

Previous wording

The cornerstone of our foundational platform technology is our intellectual property portfolio. We have pursued an active intellectual property strategy which includes focus on patents where appropriate and a diligent protection of trade secrets. To date, we have been granted 37 patents and 26 design patents. These include 13 patents on our early work on the visible and near visible portions of the electromagnetic spectrum, which were a point of creative departure as we explored and invented our current radio frequency sensor technology. These also include 9 patents related to our Particle subsidiary. We currently have a number of patents pending and continue, on a regular basis, with the filing of new patents. If we include pending patents, our IP portfolio reaches 327 patents issued and pending, which positions the company as the top worldwide IP holder in non-invasive blood glucose monitoring, according to ipCapital Group, a leading IP and innovation consulting firm. We possess all rights, title and interest to the issued patents.

Current wording

The cornerstone of our foundational platform technology is our intellectual property portfolio. We have pursued an active intellectual property strategy which includes focus on patents where appropriate and a diligent protection of trade secrets. To date, we have been granted 50 patents. We currently have a number of patents pending and continue, on a regular basis, with the filing of new patents. If we include pending patents, our IP portfolio reaches 325 patents issued and pending, which positions the company as the top worldwide IP holder in non-invasive blood glucose monitoring, according to ipCapital Group, a leading IP and innovation consulting firm. We possess all rights, title and interest to the issued patents.

Previous wording

As of March 31, 2024, we had 14 full-time and part-time employees. Our senior management and other personnel are co-located in our Seattle, Washington offices and remote. The Company expanded its utilization of consulting firms and individual contractors to supplement our reduced workforce in an effort to reduce fixed expenses and extend operating resources.

Current wording

As of June 30, 2024, we had fifteen full-time and part-time employees. Our senior management and other personnel are co-located in our Seattle, Washington offices and remote. The Company expanded its utilization of consulting firms and individual contractors to supplement our reduced workforce in an effort to reduce fixed expenses and extend operating resources.

Previous wording

Based upon the modified terms and conditions of our Series C preferred stock and Series D preferred stock certificates of designations, it was determined that Series C preferred stock and Series D preferred stock dividends need to be accreted going forward. As of March 31, 2024, cumulative unpaid Series C preferred stock and Series D preferred stock dividends totaled approximately $840,000, which on a converted-to-common-stock basis represents approximately 3,361,095 shares of common stock. We have recorded $3,590,283 in cumulative deemed dividends related to Series C preferred stock and D preferred stock which have not been paid, net of the approximately $351,000 of accumulated dividends with respect to the Series D preferred stock that were settled for 1,402,784 shares of common stock. Mr. Struve is subject to an ownership blocker limiting his ownership to 4.99% of our outstanding shares of common stock and thus the number of common shares he can receive for dividends. Unpaid accreted stock dividends will be issued to Mr. Struve if he converts preferred stock or if the Board declares a dividend thereon, limited to his 4.99% ownership blocker. Assuming no changes in the amount of outstanding Series C preferred stock or Series D preferred stock ownership, going forward on a quarterly basis the Company will accrete as a preferred dividend the value of approximately 160,000 shares of common stock, which are issuable if such dividends become payable as additional shares of preferred stock, and such preferred stock is then converted into common stock.

Current wording

Based upon the modified terms and conditions of our Series C and D Convertible Preferred Stock certificates of designations dated August 10, 2023, it was determined that Series C and D Convertible Preferred Stock dividends need to be accreted going forward. As of June 30, 2024, cumulative unpaid Series C and D Convertible Preferred Stock dividends totaled approximately $80,000, which on a converted-to-common-stock basis represents approximately 319,121 shares of common stock. We have recorded approximately $80,000 in cumulative deemed dividends related to Series C and D Convertible Preferred Stock which have not been paid, net of (i) $350,696 of accumulated dividends with respect to the Series D Convertible Preferred Stock that were settled for 1,402,784 shares of common stock on June 28, 2023 and (ii) the approximately $800,384 of accumulated dividends with respect to the Series C and D Convertible Preferred Stock that were settled for 3,201,534 shares of common stock on June 18, 2024. Mr. Struve is subject to an ownership blocker limiting his ownership to 4.99% of our outstanding shares of common stock and thus the number of common shares he can receive for dividends. Unpaid accreted stock dividends will be issued to Mr. Struve if he converts preferred stock or if the Board declares a dividend thereon, limited to his 4.99% ownership blocker. Assuming no changes in the amount of outstanding Series C Convertible Preferred Stock or Series D Convertible Preferred Stock ownership, going forward on a quarterly basis we will accrete as a preferred dividend the value of approximately 160,000 shares of common stock, which are issuable if such dividends become payable as additional shares of preferred stock, and such preferred stock is then converted into common stock.

Previous wording

On February 27, 2024, we (a) entered into a securities purchase agreement with the selling stockholder pursuant to which we may issue to the selling stockholder one or more senior convertible notes in the aggregate principal amount of up $14,400,000 for an aggregate purchase price equal to up to $12,000,000 and common stock purchase warrants and (b) issued a Note of $4,800,000 and the Warrant to the selling stockholder in exchange for a purchase price of $4,000,000 with net proceeds of $3,806,000.

Current wording

On February 27, 2024, we (i) entered into a securities purchase agreement with Lind pursuant to which we may issue to the selling stockholder one or more senior convertible notes in the aggregate principal amount of up $14,400,000 for an aggregate purchase price equal to up to $12,000,000 and common stock purchase warrants and (ii) issued a Note of $4,800,000 and the Warrant to the selling stockholder in exchange for a purchase price of $4,000,000 with net proceeds of $3,806,000.

Previous wording

On March 20, 2024, we entered into an At the Market Offering Agreement with The Benchmark Company, LLC pursuant to which we may, from time to time, offer and sell shares of our common stock through or to The Benchmark Company, LLC as our sales agent or manager in an aggregate amount of up to $5,000,000.

Current wording

On March 20, 2024, we entered into an At the Market Offering Agreement with The Benchmark Company, LLC pursuant to which we may, from time to time, offer and sell shares of our common stock through or to The Benchmark Company, LLC as our sales agent or manager in an aggregate amount of up to $5,000,000. We have not received any funds under this agreement as of June 30, 2024.

Previous wording

Research and Development Expenses.** **Research and development expenses for the three months ended March 31, 2024 decreased $388,000 to $2,175,000 as compared to $2,563,000 for the three months ended March 31, 2023. The decrease was due to reduced personnel, use of consultant, expenditures related to the development of our radio frequency spectroscopy Bio-RFID™ technology. During the year ended September 30, 2023, we reduced our headcount by nine and operating expenses and used external consultants to reduce the future cost of the development of our Bio-RFID™ technology. We launched the Generation 2 working prototype device during the three months ended March 31, 2024.

Current wording

Research and Development Expenses.** **Research and development expenses for the three months ended June 30, 2024 decreased $531,000 to $1,349,000 as compared to $1,880,000 for the three months ended June 30, 2023. The decrease was due to reduced personnel, use of consultant, expenditures related to the development of our radio frequency spectroscopy Bio-RFID™ technology. During the year ended September 30, 2023, we reduced our headcount by nine and operating expenses and used external consultants to reduce the future cost of the development of our Bio-RFID™ technology. We launched the Generation 2 working prototype device during the three months ended March 31, 2024.

Previous wording

Selling, General and Administrative Expenses.** **Selling, general and administrative expenses for the three months ended March 31, 2024 increased $308,000 to $2,551,000 as compared to $2,243,000 for the three months ended March 31, 2023. The increase primarily was due to (i) an increase of $296,000 in salaries; (ii) an increase in legal expense of $169,000; and offset by (iii) a decrease in other expenses of $157,000. As part of the selling, general and administrative expenses for the three months ended March 31, 2024 and 2023, we recorded $109,000 and $146,000, respectively, of investor relationship and business development expenses.

Current wording

Selling, General and Administrative Expenses.** **Selling, general and administrative expenses for the three months ended June 30, 2024 increased $1,128,000 to $2,487,000 as compared to $1,359,000 for the three months ended June 30, 2023. The increase primarily was due to (i) an increase of $276,000 in salaries; (ii) an increase in legal expense of $257,000; (iii) an increase in stock based compensation- stock option grants of $479,000; and (iv) an increase in other expenses of $116,000. As part of the selling, general and administrative expenses for the three months ended June 30, 2024 and 2023, we recorded $99,000 and $63,000, respectively, of investor relationship and business development expenses.

Previous wording

Other Income (Expense), Net.** **Other income (expense), net for the six months ended March 31, 2024 was $644,000 as compared to other expense net of $299,000 for the six months ended March 31, 2023. The other expense, net for the six months ended March 31, 2024 included interest income of $96,000. Increase in interest expense is related to $595,000 interest expense related to extension of notes and warrants in February 2024.

Current wording

Other Income (Expense), Net.** **Other expense, net for the three months ended June 30, 2024 was $267,000 as compared to other expense, net of $361,000 for the three months ended June 30, 2023. The other expense, net for the three months ended June 30, 2024 included interest income of $31,000, offset by interest expense of $298,000.

Previous wording

The following table sets forth key components of our results of operations during the six months ended March 31, 2024 and 2023.

Current wording

The following table sets forth key components of our results of operations during the nine months ended June 30, 2024 and 2023.

Previous wording

Research and Development Expenses.** **Research and development expenses for the six months ended March 31, 2024 decreased $646,000 to $3,661,000 as compared to $4,307,000 for the six months ended March 31, 2023. The decrease was due to reduced personnel, use of consultant, expenditures related to the development of our radio frequency spectroscopy Bio-RFID™ technology. During the year ended September 30, 2023, we reduced our headcount by nine and operating expenses and used external consultants to reduce the future cost of the development of our Bio-RFID™ technology. We launched the Generation 2 working prototype device during the three months ended March 31, 2024.

Current wording

Research and Development Expenses.** **Research and development expenses for the nine months ended June 30, 2024 decreased $1,175,000 to $5,011,000 as compared to $6,186,000 for the nine months ended June 30, 2023. The decrease was due to reduced personnel, use of consultant, expenditures related to the development of our radio frequency spectroscopy Bio-RFID™ technology. During the year ended September 30, 2023, we reduced our headcount by nine and operating expenses and used external consultants to reduce the future cost of the development of our Bio-RFID™ technology. We launched the Generation 2 working prototype device during the three months ended March 31, 2024.

Previous wording

Selling, General and Administrative Expenses.** **Selling, general and administrative expenses for the six months ended March 31, 2024 increased $392,000 to $4,539,000 as compared to $4,147,000 for the six months ended March 31, 2023. The increase primarily was due to (i) an increase of $576,000 in salaries; (ii) an increase in legal expense of $159,000; (iii) an increase in other expenses of $74,000; and offset by (iii) a decrease in stock based compensation of $417,000. As part of the selling, general and administrative expenses for the six months ended March 31, 2024 and 2023, we recorded $189,000 and $198,000, respectively, of investor relationship and business development expenses.

Current wording

Selling, General and Administrative Expenses.** **Selling, general and administrative expenses for the nine months ended June 30, 2024 increased $1,517,000 to $7,025,000 as compared to $5,508,000 for the nine months ended June 30, 2023. The increase primarily was due to (i) an increase of $851,000 in salaries; (ii) an increase in legal expense of $418,000; (iii) an increase in stock based compensation of $144,000; (iv) an increase in other expenses of $104,000. As part of the selling, general and administrative expenses for the nine months ended June 30, 2024 and 2023, we recorded $297,000 and $261,000, respectively, of investor relationship and business development expenses.

Previous wording

Other Income (Expense), Net.** **Other expense, net for the three months ended March 31, 2024 was $672,000 as compared to other expense, net of $124,000 for the three months ended March 31, 2023. The other expense, net for the three months ended March 31, 2024 included interest income of $45,000. Increase in interest expense is related to $595,000 interest expense related to extension of notes and warrants in February 2024.

Current wording

Other Income (Expense), Net.** **Other expense, net for the nine months ended June 30, 2024 was $912,000 as compared to other expense net of $559,000 for the nine months ended June 30, 2023. The other expense, net for the nine months ended June 30, 2024 included interest income of $127,000, offset by interest expense of $1,039,000. The increase in interest expense is related to $595,000 in interest expense for the extension of notes and warrants in February 2024.

Previous wording

Net Loss.** **Net loss for the six months ended March 31, 2024 was $8,844,000 as compared to $8,753,000 for the six months ended March 31, 2023. The net loss for the six months ended March 31, 2024 included non-cash expenses of $1,767,000. The non-cash items include (i) depreciation and amortization of $38,000; (ii) stock based compensation- stock options of $1,316,000; (iii) issuance of common stock for services of $277,000; and (iv) amortization of operating lease right-of-use asset of $136,000.

Current wording

Net Loss.** **Net loss for the nine months ended June 30, 2024 was $12,948,000 as compared to $12,354,000 for the nine months ended June 30, 2023. The net loss for the nine months ended June 30, 2024 included non-cash expenses of $3,801,000. The non-cash items include (i) depreciation and amortization of $59,000; (ii) stock based compensation- stock options of $2,332,000; (iii) issuance of common stock for services of $277,000; (iv) amortization of operating lease right-of-use asset of $163,000; (v) amortization of debt issuance costs of $376,000; and (vi) interest expense for extension of notes and warrants of $595,000.

Previous wording

We have cash and cash equivalents of approximately $4,710,000 and net working capital of approximately $3,467,000 (exclusive of current portion of convertible notes payable) as of March 31, 2024. We anticipate that we will record losses from operations for the foreseeable future. We believe that we have enough available cash to operate until October 31, 2024. As of March 31, 2024, we had an accumulated deficit of $130,847,000 and net losses in the amount of $8,844,000, $15,289,000 and $20,071,000 during the six months ended March 31, 2024 and years ended September 30, 2023 and 2022, respectively. We incurred non-cash expenses of $2,462,000, $4,768,000, and $12,164,000 during the six months ended March 31, 2024 and the years ended September 30, 2023 and 2022, respectively.

Current wording

We have cash and cash equivalents of approximately $2,130,000 and a net working capital deficit of $3,987,763 as of June 30, 2024. We anticipate that we will record losses from operations for the foreseeable future. We believe that we have enough available cash to operate until October 31, 2024. As of June 30, 2024, we had an accumulated deficit of $135,051,000 and net losses in the amount of $12,948,000, $15,289,000, and $20,071,000 during the nine months ended June 30, 2024 and years ended September 30, 2023 and 2022, respectively. We incurred non-cash expenses of $3,801,000, $4,768,000, and $12,164,000 during the nine months ended June 30, 2024 and the years ended September 30, 2023 and 2022, respectively.

Previous wording

On March 20, 2024, we entered into an At the Market Offering Agreement with The Benchmark Company, LLC pursuant to which we may, from time to time, offer and sell shares of our common stock through or to The Benchmark Company, LLC as our sales agent or manager in an aggregate amount of up to $5,000,000.

Current wording

On March 20, 2024, we entered into an At the Market Offering Agreement with The Benchmark Company, LLC pursuant to which we may, from time to time, offer and sell shares of our common stock through or to The Benchmark Company, LLC as our sales agent or manager in an aggregate amount of up to $5,000,000. We have not received any funds under this agreement as of June 30, 2024.

Previous wording

Net cash used in operating activities for the six months ended March 31, 2024 and 2023 was $7,048,000 and $6,341,000, respectively. The net cash used in operating activities for the six months ended March 31, 2024 was primarily related to (i) a net loss of $8,844,000; (ii) working capital changes of $666,000; and offset by (iii) non-cash expenses of $2,462,000. The non-cash items include (iv) depreciation and amortization of $38,000; (v) stock based compensation- stock options of $1,316,000; (vi) issuance of common stock for services of $277,000; (vii) amortization of operating lease right-of-use asset of $136,000; amortization of debt issuance costs of $100,000; and (viii) interest expense for extension of notes and warrants of 595,000.

Current wording

Net cash used in operating activities for the nine months ended June 30, 2024 and 2023 was $9,574,000 and $8,976,000, respectively. The net cash used in operating activities for the nine months ended June 30, 2024 was primarily related to (i) a net loss of $12,948,000; (ii) working capital changes of $427,000; and offset by (iii) non-cash expenses of $3,801,000. The non-cash items include (iv) depreciation and amortization of $59,000; (v) stock based compensation- stock options of $2,332,000; (vi) issuance of common stock for services of $277.000; (vii) amortization of operating lease right-of-use asset of $163,000; amortization of debt issuance costs of $376,000; and (viii) interest expense for extension of notes and warrants of $595,000.

Previous wording

The net cash used in operating activities for the six months ended March 31, 2023 was primarily related to (i) a net loss of $8,753,000; and (ii) working capital changes of $159,000; and offset by (iii) non-cash expenses of $2,572,000.

Current wording

The net cash used in operating activities for the nine months ended June 30, 2023 was primarily related to (i) a net loss of $12,353,000; and (ii) working capital changes of $77,000; and offset by (iii) non-cash expenses of $3,454,000. The non-cash items include (iv) depreciation and amortization of $259,000; (v) loss on disposal of assets of $384,000 related to the consolidation of leased offices; (vi) modification of notes and warrants of $350,000; (vii) stock based compensation- stock options of $2,464,000; and (xiii) amortization of operating lease right-of-use asset of $96,000.

Previous wording

Net cash used in investing activities for the six months ended March 31, 2024 and 2023 was $13,000 and $42,000, respectively. There amounts were primarily related to the investment in equipment for research and development.

Current wording

Net cash used in investing activities for the nine months ended June 30, 2024 and 2023 was $66,000 and $81,000, respectively. These amounts were primarily related to the investment in equipment for research and development.

Previous wording

Net cash provided by financing activities for the for the six months ended March 31, 2024 and 2023 was $3,746,000 and $15,000, respectively. The net cash provided by financing activities for the six months ended March 31, 2024 was primarily related to the proceeds from debt offering of $3,806,000 less expenses of $262,000 and issuance of common stock for a common stock offering, net of expenses of $203,000. On February 27, 2024, we (a) entered into a securities purchase agreement with the selling stockholder pursuant to which we may issue to the selling stockholder one or more senior convertible notes in the aggregate principal amount of up $14,400,000 for an aggregate purchase price equal to up to $12,000,000 and common stock purchase warrants and (b) issued the Note and the Warrant to the selling stockholder in exchange for a purchase price of $4,000,000. On October 26, 2023, we closed an offering of our common stock pursuant to which we sold 883,061 shares of common stock, at a purchase price of $0.25 per share. After deducting underwriting commissions and other offering expenses, we received net proceeds of $203,000.

Current wording

Net cash provided by financing activities for the for the nine months ended June 30, 2024 and 2023 was $3,746,000 and $392,000, respectively. The net cash provided by financing activities for the nine months ended June 30, 2024 was primarily related to the proceeds from debt offering of $3,806,000 less expenses of $262,000 and issuance of common stock for a common stock offering, net of expenses of $203,000. On February 27, 2024, we (a) entered into a securities purchase agreement with the selling stockholder pursuant to which we may issue to the selling stockholder one or more senior convertible notes in the aggregate principal amount of up $14,400,000 for an aggregate purchase price equal to up to $12,000,000 and common stock purchase warrants and (b) issued the Note and the Warrant to the selling stockholder in exchange for a purchase price of $4,000,000. On October 26, 2023, we closed an offering of our common stock pursuant to which we sold 883,061 shares of common stock, at a purchase price of $0.25 per share. After deducting underwriting commissions and other offering expenses, we received net proceeds of $203,000.

Previous wording

The net cash provided by financing activities for the six months ended March 31, 2023 was primarily related to (i) proceeds from the issuance of common stock for the exercise of warrants of $13,000; and (ii) proceeds from the issuance of common stock for the exercise of stock option grants of $2,000.

Current wording

The net cash provided by financing activities for the nine months ended June 30, 2023 was primarily related to (i) proceeds from the issuance of common stock for the exercise of warrants of $387,000; and (ii) proceeds from the issuance of common stock for the exercise of stock option grants of $5,000.

Previous wording

We have a money market account which is considered a Level 1 asset. The balance as of March 31, 2024 and September 30, 2023 was $4,783,000, and $7,836,000, respectively. No other assets or liabilities are required to be recorded at fair value on a recurring nature.

Current wording

We have a money market account which is considered a Level 1 asset. The balance as of June 30, 2024 and September 30, 2023 was $2,013,000 and $7,836,000, respectively. No other assets or liabilities are required to be recorded at fair value on a recurring nature.
Rearranged current paragraphs (1)

Current report — wording carried from elsewhere

On February 27, 2024, we (i) entered into a securities purchase agreement with Lind pursuant to which we may issue to the selling stockholder one or more senior convertible notes in the aggregate principal amount of up $14,400,000 for an aggregate purchase price equal to up to $12,000,000 and common stock purchase warrants and (ii) issued a Note of $4,800,000 and the Warrant to the selling stockholder in exchange for a purchase price of $4,000,000 with net proceeds of $3,806,000.