36 unchanged sentences
Information that is contained in and can be accessed through our website, Twitter posts and LinkedIn are not incorporated into, and do not form a part of, this Quarterly Report or any other report or document we file with the SEC.
−Removed: We are developing a next-generation enhanced ultrasound devices to develop technology for increasing the capabilities of clinical diagnostic ultrasound, to broaden patient access to the safe diagnosis and treatment of a number of significant medical conditions in circumstances where expensive X-ray computed tomography (“CT”), magnetic resonance imaging (“MRI”) technology, or other diagnostic technologies such as surgical biopsy, are unavailable or impractical.
+Added: We are developing a next-generation enhanced ultrasound devices to develop technology for characterizing tissue non-invasively, at the point of patient care, to broaden patient access to the safe diagnosis and treatment of a number of significant medical conditions in circumstances where expensive X-ray computed tomography (“CT”), magnetic resonance imaging (“MRI”) technology, or other diagnostic technologies, such as surgical biopsy, are unavailable or impractical.
Building on our expertise in thermoacoustics, we have developed a next-generation technology platform—Thermo Acoustic Enhanced Ultrasound, or TAEUS—which is intended to enhance the capability of clinical ultrasound technology and support the diagnosis and treatment of a number of significant medical conditions that currently require the use of expensive CT or MRI imaging or where imaging is not practical using existing technology.
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In February 2022, we announced that we will pursue FDA reclassification and clearance of our TAEUS® FLIP System through the FDA’s “de novo” process.
−Removed: We voluntarily withdrew our 510(k) application and plan to submit an application for de novo review, which will include additional clinical data, as soon as practicable in 2023.
+Added: We subsequently voluntarily withdrew our 510(k) application, and on August 14, 2023, we announced the submission of a de novo request for the TAEUS system to the FDA.
Financial Operations Overview
−Removed: No revenue has been generated by our TAEUS technology, which we have not commercially sold as of June 30, 2023.
+Added: No revenue has been generated by our TAEUS technology, which we have not commercially sold as of September 30, 2023.
Research and Development Expenses
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In connection with the commercialization of our TAEUS applications, we are building a small sales and marketing team to train and support global ultrasound distributors, and expect to execute traditional marketing activities such as promotional materials, electronic media and participation in industry events and conferences.
−Removed: As of June 30, 2023, we had a full-time sales representative in each of the United Kingdom, France and Germany.
+Added: As of September 30, 2023, we had a full-time sales representative in each of the United Kingdom, France and Germany.
We expect to continue actively adding to our sales representation and support headcount for operations in the EU in the coming quarters, and plan to begin staffing our sales efforts in the United States once we have obtained FDA approval for the sale of the NAFLD TAEUS device in that region, in each case as our financial resources permit.
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On January 1, 2023, the pool of shares issuable under the Omnibus Plan automatically increased by 867,966 shares from 454,203 shares to 1,322,169 shares.
−Removed: As of June 30, 2023, there were 675,520 shares of common stock remaining available for issuance under the Omnibus Plan.
+Added: As of September 30, 2023, there were 675,520 shares of common stock remaining available for issuance under the Omnibus Plan.
We record share-based compensation in accordance with the provisions of the Share-based Compensation Topic of the FASB Codification.
6 unchanged sentences
Results of Operations
−Removed: Three months ended June 30, 2023 and 2022
−Removed: We had no revenue during the three months ended June 30, 2023 and 2022.
+Added: Three months ended September 30, 2023 and 2022
+Added: We had no revenue during the three months ended September 30, 2023 and 2022.
Cost of Goods Sold
−Removed: We had no cost of goods sold during the three months ended June 30, 2023 and 2022.
+Added: We had no cost of goods sold during the three months ended September 30, 2023 and 2022.
Research and Development
−Removed: Research and development expenses were $1,400,182 for the three months ended June 30, 2023, as compared to $1,847,560 for the three months ended June 30, 2022, a decrease of $447,378, or 24%.
+Added: Research and development expenses were $1,632,849 for the three months ended September 30, 2023, as compared to $1,830,297 for the three months ended September 30, 2022, a decrease of $197,448, or 11%.
The costs include primarily wages, fees and equipment for the development of our TAEUS product line.
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Sales and Marketing
−Removed: Sales and marketing expenses were $247,773 for the three months ended June 30, 2023, as compared to $342,039 for the three months ended June 30, 2022, a decrease of $94,266, or 28%.
+Added: Sales and marketing expenses were $243,332 for the three months ended September 30, 2023, as compared to $420,439 for the three months ended September 30, 2022, a decrease of $177,107, or 42%.
The costs include primarily headcount and pre-selling activities for our TAEUS product line.
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General and Administrative
−Removed: Our general and administrative expenses for the three months ended June 30, 2023 were $1,346,610, compared to $1,382,094 for the three months ended June 30, 2022, a decrease of $62,868, or 3%.
−Removed: Our wage and related expenses for the three months ended June 30, 2023 were $558,068, compared to $569,712 for the three months ended June 30, 2022.
−Removed: Wage and related expenses in the three months ended June 30, 2023 included $67,932 for accrued bonuses and $88,200 of stock compensation expense related to the issuance and vesting of options, compared to $67,932 for bonuses and $111,819 of stock compensation expense related to the issuance and vesting of options, for the three months ended June 30, 2022.
−Removed: Our professional fees, which include legal, audit, and investor relations, for the three months ended June 30, 2023 were $503,697, compared to $545,614 for the three months ended June 30, 2022.
−Removed: Other income for the three months ended June 30, 2023 was $437,433, and resulted mostly from the completion of the Employer Retention Tax Credit for employee retention in 2021 and 2022 of $ 413,844.
−Removed: As a result of the foregoing, for the three months ended June 30, 2023, we recorded a net loss of $2,557,132, compared to a net loss of $3,591,067 for the three months ended June 30, 2022.
−Removed: Six months ended June 30, 2023 and 2022
−Removed: We had no revenue during the six months ended June 30, 2023 and 2022.
+Added: Our general and administrative expenses for the three months ended September 30, 2023 were $1,252,881, compared to $1,166,480 for the three months ended September 30, 2022, an increase of $86,401, or 7%.
+Added: Our wage and related expenses for the three months ended September 30, 2023 were $565,639, compared to $479,228 for the three months ended September 30, 2022.
+Added: Wage and related expenses in the three months ended September 30, 2023 included $67,932 for accrued bonuses and $86,883 of stock compensation expense related to the issuance and vesting of options, compared to $67,932 for bonuses and $111,861 of stock compensation expense related to the issuance and vesting of options, for the three months ended September 30, 2022.
+Added: Our professional fees, which include legal, audit, and investor relations, for the three months ended September 30, 2023 were $447,515, compared to $454,707 for the three months ended September 30, 2022.
+Added: As a result of the foregoing, for the three months ended September 30, 2023, we recorded a net loss of $3,100,836, compared to a net loss of $3,440,227 for the three months ended September 30, 2022.
+Added: Nine months ended September 30, 2023 and 2022
+Added: We had no revenue during the nine months ended September 30, 2023 and 2022.
Cost of Goods Sold
−Removed: We had no cost of goods sold during the six months ended June 30, 2023 and 2022.
+Added: We had no cost of goods sold during the nine months ended September 30, 2023 and 2022.
Research and Development
−Removed: Research and development expenses were $2,791,496 for the six months ended June 30, 2023, as compared to $3,060,582 for the six months ended June 30, 2022, a decrease of $269,086, or 9%.
+Added: Research and development expenses were $4,424,345 for the nine months ended September 30, 2023, as compared to $4,890,879 for the nine months ended September 30, 2022, a decrease of $466,534, or 10%.
The costs include primarily wages, fees and equipment for the development of our TAEUS product line.
1 unchanged sentence
Sales and Marketing
−Removed: Sales and marketing expenses were $429,389 for the six months ended June 30, 2023, as compared to $681,942 for the six months ended June 30, 2022, a decrease of $252,553, or 37%.
+Added: Sales and marketing expenses were $672,721 for the nine months ended September 30, 2023, as compared to $1,102,381 for the nine months ended September 30, 2022, a decrease of $429,660, or 39%.
The costs include primarily headcount and pre-selling activities for our TAEUS product line.
2 unchanged sentences
General and Administrative
−Removed: Our general and administrative expenses for the six months ended June 30, 2023 were $2,713,008, compared to $2,684,438 for the six months ended June 30, 2022, an increase of $28,570, or 1%.
−Removed: Our wage and related expenses for the six months ended June 30, 2023 were $1,169,887, compared to $1,121,025 for the six months ended June 30, 2022.
−Removed: Wage and related expenses in the six months ended June 30, 2023 included $135,864 for accrued bonuses and $166,065 of stock compensation expense related to the issuance and vesting of options, compared to $113,475 for bonuses and $200,775 of stock compensation expense related to the issuance and vesting of options, for the six months ended June 30, 2022.
−Removed: Our professional fees, which include legal, audit, and investor relations, for the six months ended June 30, 2023 were $1,024,335, compared to $1,049,109 for the six months ended June 30, 2022.
−Removed: Other income for the six months ended June 30, 2023, was $434,015, and resulted mostly from the completion of the Employer Retention Tax Credit for employee retention in 2021 and 2022 of $413,844.
−Removed: As a result of the foregoing, for the six months ended June 30, 2023, we recorded a net loss of $5,499,878, compared to a net loss of $6,449,269 for the six months ended June 30, 2022.
+Added: Our general and administrative expenses for the nine months ended September 30, 2023 were $3,965,889, compared to $3,850,918 for the nine months ended September 30, 2022, an increase of $114,971, or 3%.
+Added: Our wage and related expenses for the nine months ended September 30, 2023 were $1,735,526, compared to $1,600,240 for the nine months ended September 30, 2022.
+Added: Wage and related expenses in the nine months ended September 30, 2023 included $203,796 for accrued bonuses and $252,948 of stock compensation expense related to the issuance and vesting of options, compared to $181,407 for bonuses and $312,636 of stock compensation expense related to the issuance and vesting of options, for the nine months ended September 30, 2022.
+Added: Our professional fees, which include legal, audit, and investor relations, for the nine months ended September 30, 2023 were $1,471,850, compared to $1,503,816 for the nine months ended September 30, 2022.
+Added: Other income for the nine months ended September 30, 2023, was $462,241, and resulted mostly from the completion of the Employer Retention Tax Credit for employee retention in 2021 and 2022 of $413,844.
+Added: As a result of the foregoing, for the nine months ended September 30, 2023, we recorded a net loss of $8,600,714, compared to a net loss of $9,889,496 for the nine months ended September 30, 2022.
Near-Term Liquidity and Capital Resources
Since inception, we have incurred losses and expect to continue to incur losses for the foreseeable future.
−Removed: As of June 30, 2023, we had an accumulated deficit of $87,369,780 and had $4,819,459 in cash.
+Added: As of September 30, 2023, we had an accumulated deficit of $90,470,616 and had $3,334,536 in cash.
To date we have funded our operations through private and public sales of our securities and will need to raise additional funds in order to execute on our business plan, fully commercialize our TAEUS technology, and generate revenues.
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The consolidated financial statements included in this Form 10-Q have been prepared assuming we will continue as a going concern, which contemplates the realization of assets and the settlement of liabilities and commitments in the normal course of business.
−Removed: As reflected in the accompanying consolidated financial statements, during the six months ended June 30, 2023, we incurred net losses of $5,499,878 and used cash in operations of $4,775,442.
−Removed: In light of our cash balance as of June 30, 2023, we will need to raise additional capital in order to fund operations through the next twelve months, and prior to any ability to fund operations from revenue generated from the sale of our products.
+Added: As reflected in the accompanying consolidated financial statements, during the nine months ended September 30, 2023, we incurred net losses of $8,600,714 and used cash in operations of $7,374,197.
+Added: In light of our cash balance as of September 30, 2023, we will need to raise additional capital in order to fund operations through the next twelve months, and prior to any ability to fund operations from revenue generated from the sale of our products.
The financial statements do not include any adjustments that might be necessary should we be unable to continue as a going concern.
Operating Activities
−Removed: During the six months ended June 30, 2023, we used $4,775,442 of cash in operating activities primarily as a result of our net loss of $5,499,878, offset by share-based compensation of $493,134, depreciation expense of $69,781, amortization of right of use assets of $73,974, and net changes in operating assets and liabilities of $87,547.
−Removed: During the six months ended June 30, 2022, we used $6,433,852 of cash in operating activities primarily as a result of our net loss of $6,449,269, offset by share-based compensation of $599,886, depreciation expense of $40,739, amortization of right of use assets of $67,158, and net changes in operating assets and liabilities of $(692,366).
+Added: During the nine months ended September 30, 2023, we used $7,374,197 of cash in operating activities primarily as a result of our net loss of $8,600,714, offset by share-based compensation of $745,873, depreciation expense of $101,839, amortization of right of use assets of $112,365, and net changes in operating assets and liabilities of $266,440.
+Added: During the nine months ended September 30, 2022, we used $9,680,682 of cash in operating activities primarily as a result of our net loss of $9,889,496, offset by share-based compensation of $909,069, depreciation expense of $64,532, amortization of right of use assets of $101,957, and net changes in operating assets and liabilities of $(866,744).
Investing Activities
−Removed: During the six months ended June 30, 2023, we used $27,000 in investing activities related to purchases of fixed assets.
−Removed: During the six months ended June 30, 2022, we used $149,153 in investing activities related to purchases of equipment.
+Added: During the nine months ended September 30, 2023, we used $27,000 in investing activities related to purchases of fixed assets.
+Added: During the nine months ended September 30, 2022, we used $164,014 in investing activities related to purchases of equipment.
Financing Activities
−Removed: During the six months ended June 30, 2023, our financing activities provided $4,732,803 in proceeds from issuances of common stock and warrants.
−Removed: During the six months ended June 30, 2022, our financing activities provided $8,399,512 in proceeds from issuances of common stock.
+Added: During the nine months ended September 30, 2023, our financing activities provided $5,846,635 in proceeds from issuances of common stock and warrants.
+Added: During the nine months ended September 30, 2022, our financing activities provided $8,399,512 in proceeds from issuances of common stock.
Long-Term Liquidity
23 unchanged sentences
Off-Balance Sheet Transactions
−Removed: At June 30, 2023, the Company did not have any transactions, obligations or relationships that could be considered off-balance sheet arrangements.
+Added: At September 30, 2023, the Company did not have any transactions, obligations or relationships that could be considered off-balance sheet arrangements.
Quantitative and Qualitative Disclosure About Market Risk
1 unchanged sentence
Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.