53 unchanged sentences
In July 2023, we submitted the amended protocols to the FDA and we plan to initiate a Phase 3 program in the second half of 2023, assuming the receipt of final approval from the FDA.
−Removed: In addition, based on the multiple mechanisms of action and anti-inflammatory effect seen with DMT310 acne trial, we completed a Phase 1b proof of concept, or POC, trial in psoriasis where we saw encouraging results warranting further investigation.
+Added: In addition, based on the multiple mechanisms of action and anti-inflammatory effect seen with DMT310 acne trial, we have conducted a Phase 1b proof of concept, or POC, trial in psoriasis where we saw encouraging results warranting further investigation.
DMT310 consists of two grams of powder processed from the naturally grown freshwater sponge, Spongilla lacustris.
27 unchanged sentences
We have not generated any revenue to date and have incurred significant operating losses.
−Removed: Our net losses were $1.7 million and $2.7 million for the three months ended June 30, 2023, and 2022, respectively, and as of June 30, 2023, we had an accumulated deficit of $49.5 million.
+Added: Our net losses were $1.7 million and $2.4 million for the three months ended September 30, 2023, and 2022, respectively, and as of September 30, 2023, we had an accumulated deficit of $51.3 million.
We expect to continue to incur significant expenses and operating losses for the foreseeable future.
53 unchanged sentences
Results of Operations
−Removed: Three Months Ended June 30, 2023, and 2022
+Added: Three Months Ended September 30, 2023, and 2022
The following table summarizes our results of operations for the periods presented:
Three Months Ended
+Added: September 30,
Operating expenses:
8 unchanged sentences
Research and Development Expenses
−Removed: Research and development expenses decreased by $0.8 million from $1.6 million for the three months ended June 30, 2022, to $0.8 million for the three months ended June 30, 2023.
−Removed: The decrease in research and development expense from the second quarter of 2023 as compared the same period in 2022 resulted from $0.7 million of decreased clinical expenses from the DMT310 rosacea study completed in late 2022 and $0.2 million of decreased non-clinical expenses, offset by $0.1 million of increased chemistry, manufacturing, and controls, or CMC, expenses in preparation for the DMT310 Phase 3 program which is expected to start in the second half of 2023.
+Added: Research and development expenses decreased by $0.7 million from $1.6 million for the three months ended September 30, 2022, to $0.9 million for the three months ended September 30, 2023.
+Added: The decrease in research and development expenses from the third quarter of 2023 as compared the same period in 2022 resulted from $0.5 million of decreased clinical expenses from the DMT310 rosacea study completed in late 2022 and $0.3 million of decreased non-clinical expenses, offset by $0.1 million of increased chemistry, manufacturing, and controls, or CMC, expenses in preparation for the DMT310 Phase 3 program.
General and Administrative Expenses
−Removed: General and administrative expenses decreased by $0.2 million from $1.1 million for the three months ended June 30, 2022, to $0.9 million for the three months ended June 30, 2023.
−Removed: This decrease resulted from decreased insurance costs of $0.1 million, as well as decreased stock-based compensation expense of $0.1 million.
+Added: General and administrative expenses were $0.9 million for the three months ended September 30, 2023, and 2022, respectively.
Other Income and Expenses
−Removed: Other income and expenses increased by $31,050 from the three months ended June 30, 2023, as result of interest income earned from cash sweep accounts, which were opened during the third quarter of 2022.
−Removed: Six Months Ended June 30, 2023, and 2022
+Added: Other income and expenses increased by $71,281 from the three months ended September 30, 2023, as result of interest income earned from cash sweep accounts that were opened during the third quarter of 2022.
+Added: Nine Months Ended September 30, 2023, and 2022
The following table summarizes our results of operations for the periods presented:
−Removed: Six Months Ended June 30,
+Added: Nine Months Ended September 30,
Operating expenses:
5 unchanged sentences
Other income and expenses:
−Removed: Interest expense, net
+Added: Interest income, net
$ (5,660,717 )
1 unchanged sentence
Research and Development Expenses
−Removed: Research and development expenses decreased by $1.2 million from $3.2 million for the six months ended June 30, 2022, to $2.0 million for the six months ended June 30, 2023.
−Removed: The decrease in research and development expense resulted from $1.5 million of decreased clinical expenses from the DMT310 rosacea study completed in late 2022, offset by $0.3 million of increased CMC expenses in preparation for the DMT310 Phase 3 program which is expected to start in the second half of 2023.
+Added: Research and development expenses decreased by approximately $1.9 million from $4.8 million for the nine months ended September 30, 2022, to $2.9 million for the nine months ended September 30, 2023.
+Added: The decrease in research and development expenses resulted from a $2.0 million decrease in clinical expenses and a $0.3 million decrease in non-clinical expenses, offset by $0.4 million of increased CMC expenses in preparation for the DMT310 Phase 3 program.
General and Administrative Expenses
−Removed: General and administrative expenses decreased by $0.3 million from $2.3 million for the six months ended June 30, 2022, to $2.0 million for the six months ended June 30, 2023.
−Removed: This decrease resulted from decreased insurance costs of $0.2 million, as well as decreased stock-based compensation expense of $0.2 million, offset by an increase in employee costs of $0.1 million.
+Added: General and administrative expenses decreased by $0.3 million from $3.2 million for the nine months ended September 30, 2022, to $2.9 million for the nine months ended September 30, 2023.
+Added: This decrease resulted from decreased insurance costs of $0.2 million, as well as decreased stock-based compensation expense of $0.3 million, offset by an increase in public company expenses of $0.2 million primarily related to professional services.
Other Income and Expenses
−Removed: Other income and expenses increased by $68,590 from the six months ended June 30, 2023, as result of interest income earned from cash sweep accounts, which were opened during the third quarter of 2022.
+Added: Other income and expenses increased by $139,871 from the nine months ended September 30, 2023, as result of interest income earned from cash sweep accounts, which were opened during the third quarter of 2022.
The following table summarizes our cash flows from operating and financing activities:
−Removed: Six Months Ended
+Added: Nine Months Ended
+Added: September 30,
Statements of cash flows data:
5 unchanged sentences
Increase (decrease) in cash and cash equivalents
+Added: $ (2,731,984 )
Operating activities
−Removed: Cash used in operations of $3.5 million for the six months ended June 30, 2023, was the result of the net loss of $3.9 million, offset by non-cash stock-based compensation of $0.3 million, as well as a decrease in accounts payable and accrued and other current liabilities of $0.2 million and a decrease in prepaid expenses and other current assets of $0.4 million.
−Removed: Cash used in operations of $4.4 million for the six months ended June 30, 2022, was the result of the net loss of $5.5 million, offset by non-cash stock-based compensation of $0.5 million, as well as an increase in accounts payable and accrued and other current liabilities of $0.2 million and a decrease in prepaid expenses and other current assets of $0.4 million.
+Added: Cash used in operations of $5.3 million for the nine months ended September 30, 2023, was the result of the net loss of $5.7 million, offset by non-cash stock-based compensation of $0.4 million.
+Added: Cash used in operations of $7.0 million for the nine months ended September 30, 2022, was the result of the net loss of $7.9 million and an increase in prepaid expenses and other current assets of $0.1 million, offset by non-cash stock-based compensation of $0.7 million and an increase in accrued and other current liabilities of $0.3 million.
Financing activities
−Removed: Cash provided by financing activities of $5.7 million for the six months ended June 30, 2023, was the result of $4.2 million of net proceeds received from the issuance of Common Stock and warrants issued in the March 2023 Offering, as well as $1.5 million of net proceeds received from the May 2023 Offering.
−Removed: Cash provided by financing activities of $4.3 million for the six months ended June 30, 2022, was the result of the net proceeds received from the issuance of Common Stock and warrants issued in April 2022 from a private placement of the Company’s securities.
+Added: Cash provided by financing activities of $5.7 million for the nine months ended September 30, 2023, was the result of $4.2 million of net proceeds received from the issuance of Common Stock and warrants issued in the March 2023 Offering, as well as $1.5 million of net proceeds received from the May 2023 Offering.
+Added: Cash provided by financing activities of $4.3 million for the nine months ended September 30, 2022, was the result of the net proceeds received from the issuance of Common Stock and warrants issued in April 2022 from a private placement of the Company’s securities.
Liquidity and Capital Resources
Since our inception, we have not generated any revenue or commercialized any products.
−Removed: As of June 30, 2023, our cash and cash equivalents totaled $8.4 million, and we had an accumulated deficit of $49.5 million.
−Removed: For the six months ended June 30, 2023, and the year ended December 31, 2022, we used cash of $3.5 million and $8.8 million, respectively, in operations.
+Added: As of September 30, 2023, our cash and cash equivalents totaled $6.6 million, and we had an accumulated deficit of $51.3 million.
+Added: For the nine months ended September 30, 2023, and the year ended December 31, 2022, we used cash of $5.3 million and $8.8 million, respectively, in operations.
As a result of the sales of our Common Stock and warrants to purchase Common Stock in the March 2023 Offering and the May 2023 Offering for net proceeds of $4.2 million and $1.5 million, respectively, our cash balances are expected to fund operations into the second quarter of 2024.
5 unchanged sentences
Funding Requirements
−Removed: We plan to focus in the near term on the development, regulatory approval, and potential commercialization of DMT310 for the treatment of acne and psoriasis.
+Added: We plan to focus in the near term on the development, regulatory approval, and potential commercialization of DMT310 for the treatment of acne.
We anticipate we will incur net losses for the next several years as we complete clinical development of DMT310 for the treatment of acne and psoriasis and continue research and development of DMT410 for the treatment of aesthetic and medical skin conditions.
11 unchanged sentences
We will require additional capital to conduct Phase 3 studies for DMT310 for the treatment of acne, continue development of DMT310, and to pursue in licenses or acquisitions of other drug candidates.
−Removed: Additional funds may not be available on a timely basis, on favorable terms, or at all, and such funds, if raised, may not be sufficient to enable us to continue to implement our long-term business strategy.
−Removed: If we are unable to raise sufficient additional capital, we may need to substantially curtail our planned operations and the pursuit of our growth strategy.
+Added: Therefore, based on our recurring losses from operations incurred since inception, expectation of continuing operating losses for the foreseeable future, and the need to raise additional capital to finance future operations, we are developing plans to mitigate this risk, which may consist of raising additional capital through some combination of equity or debt financings, and/or potentially new collaborations, business transactions, and reducing cash expenditures.
+Added: If we are not able to secure adequate additional funding, we may be forced to make significant reductions in our operations and the pursuit of our growth strategy.
+Added: In that event, we may have to delay, scale back, or eliminate some or all of our research and development programs and activities which could adversely affect our business prospects, or we may be unable to continue operations.
We may raise additional capital through the sale of equity or convertible debt securities.
29 unchanged sentences
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.