24 unchanged sentences
On June 29, 2021, we completed our IPO, in which we issued and sold 2,875,000 shares of our common stock, including the full exercise by the underwriters of their option to purchase 375,000 additional shares of our common stock, at a public offering price of $6.00 per share, which resulted in net proceeds of $14.8 million after deducting underwriting discounts and commissions and offering expenses.
−Removed: The proceeds from the IPO are being used (i) to complete the Phase 2b clinical trial of ibezapolstat in patients with CDI (approximately $4 million), (ii) to complete pre-clinical development of ACX-375C and (iii) for general corporate purposes, which may include, without limitation, expenditures relating to research, development and clinical trials other than those specified above, manufacturing, capital expenditures, hiring additional personnel, acquisitions of new technologies or products, the payment, repayment, refinancing, redemption or repurchase of existing or future indebtedness, obligations or capital stock, and working capital.
+Added: The proceeds from the IPO are being used (i) to complete the Phase 2b clinical trial of ibezapolstat in patients with CDI, (ii) to complete pre-clinical development of ACX-375C and (iii) for general corporate purposes, which may include, without limitation, expenditures relating to research, development and clinical trials other than those specified above, manufacturing, capital expenditures, hiring additional personnel, acquisitions of new technologies or products, the payment, repayment, refinancing, redemption or repurchase of existing or future indebtedness, obligations or capital stock, and working capital.
Prior to the IPO, we converted from a Delaware limited liability company into a Delaware corporation, and our previously outstanding Class A membership interests and Class B membership interests were converted to shares of common stock pursuant to a conversion ratio of one-half of one share of common stock for each Class A membership interest or Class B membership interest outstanding, resulting in the conversion of 14,082,318 Class A membership interests and Class B membership interests into 7,041,208 shares of common stock.
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Upon forgiveness of the PPP Loan, we reduced the liability and recorded a gain on extinguishment of debt in our statement of operations.
+Added: Health Holland Innovative Research Grant
+Added: In July 2021, Health Holland awarded an innovative research grant of approximately $500,000 to Leiden University Medical Center (“LUMC”)..
+Added: The Company is participating as a scientific collaborator in this research study, which is designed to further study the mechanism of action of DNA Pol IIIC inhibitors.
Results of Operations
−Removed: Three Months Ended June 30, 2021 Compared to the Three Months Ended June 30, 2020
−Removed: The following table presents a summary of the changes in our results of operations for the three months ended June 30, 2021 compared with the three months ended June 30, 2020:
+Added: Three Months Ended September 30, 2021 Compared to the Three Months Ended September 30, 2020
+Added: The following table presents a summary of the changes in our results of operations for the three months ended September 30, 2021 compared with the three months ended September 30, 2020:
Three Months Ended
+Added: September 30,
Increase (Decrease)
3 unchanged sentences
Total Operating Expenses
−Removed: Gain on PPP Loan Forgiveness
Research and Development Expenses
−Removed: Research and development expenses were $0.1 million for the three months ended June 30, 2021, and $0.4 million for the three months ended June 30, 2020, a decrease of $0.3 million.
−Removed: The decrease was due to a $0.2 million decrease in Phase 2a clinical trial related costs which was completed in 2020, and a $0.1 million decrease in consulting costs.
+Added: Research and development expenses were $1.1 million for the three months ended September 30, 2021, and $0.7 million for the three months ended September 30, 2020, an increase of $0.4 primarily due to the increase in Phase 2b clinical trial related costs.
Selling, General and Administrative Expenses
−Removed: Selling, general and administrative expenses were $3.9 million for the three months ended June 30, 2021 and $0.5 million for the three months ended June 30, 2020, an increase of $3.4 million.
−Removed: The increase was primarily due to a $0.4 million increase in stock-based director fees due to accelerated vesting of certain stock awards, a $1.7 million increase in stock-based compensation expense, a $1.2 million increase in professional fees, and a $0.1 million related to other employee related expenses.
−Removed: Gain on the Forgiveness of the Paycheck Protection Program Loan
−Removed: We recorded a gain of $.07 million for the three months ended June 30, 2021 associated with the forgiveness of the PPP Loan.
−Removed: Net loss was $4.0 million for the three months ended June 30, 2021, and $0.9 million for the three months ended June 30, 2020, an increase of $3.1 million, due to the reasons stated above.
−Removed: Six Months Ended June 30, 2021 Compared to the Six Months Ended June 30, 2020
−Removed: The following table presents a summary of the changes in our results of operations for the six months ended June 30, 2021 compared with the six months ended June 30, 2020:
−Removed: Six Months Ended
+Added: Selling, general and administrative expenses were $3.5 million for the three months ended September 30, 2021 and $0.7 million for the three months ended September 30, 2020, an increase of $2.8 million.
+Added: The increase was primarily due to a $2.0 million increase in stock-based compensation expense, a $0.2 million increase in professional fees, $0.3 million related to other employee related expenses, and $0.3 million increase in legal and insurance costs
+Added: Net loss was $4.6 million for the three months ended September 30, 2021, and $1.3 million for the three months ended September 30, 2020, an increase of $3.3 million, due to the reasons stated above.
+Added: Nine Months Ended September 30, 2021 Compared to the Nine Months Ended September 30, 2020
+Added: The following table presents a summary of the changes in our results of operations for the nine months ended September 30, 2021 compared with the nine months ended September 30, 2020:
+Added: Nine Months Ended
+Added: September 30,
Increase (Decrease)
5 unchanged sentences
Research and Development Expenses
−Removed: Research and development expenses were $0.2 million for the six months ended June 30, 2021, and $1.1 million for the six months ended June 30, 2020, a decrease of $0.9 million.
−Removed: Research and development expenses decreased due to a $0.3 million decrease in Phase 2a clinical trial related costs which was completed in 2020, and a $0.6 million decrease in consulting costs.
+Added: Research and development expenses were $1.3 million for the nine months ended September 30, 2021, and $1.7 million for the nine months ended September 30, 2020, a decrease of $0.4 million primarily due to a decrease in Phase 2a clinical trial related costs which was completed in 2020.
Selling, General and Administrative Expenses
−Removed: Selling, general and administrative expenses were $5.4 million for the six months ended June 30, 2021, and $1.1 million for the six months ended June 30, 2020, an increase of $4.3 million.
−Removed: The increase in selling, general and administrative expenses is primarily attributable to a $2.4 million increase in stock-based compensation expenses, $1.4 million increase in professional fees, and a $0.5 million increase in stock-based director fees due to accelerated vesting of certain stock awards.
+Added: Selling, general and administrative expenses were $8.9 million for the nine months ended September 30, 2021, and $1.8 million for the nine months ended September 30, 2020, an increase of $7.1 million.
+Added: The increase in selling, general and administrative expenses is primarily attributable to a $4.5 million increase in stock-based compensation, $1.5 million increase in professional fees, $0.5 million of employee related expenses, a $0.3 million increase in stock-based director fees due to accelerated vesting, and $0.3 million increase in legal and insurance costs.
Gain on the Forgiveness of the Paycheck Protection Program Loan
−Removed: We recorded a gain of $.07 million for the six months ended June 30, 2021 associated with the forgiveness of the PPP Loan.
−Removed: Net loss was $5.5 million for the six months ended June 30, 2021, and $2.2 million for the six months ended June 30, 2020, an increase of $3.3 million, primarily due to an increase in selling, general, and administrative expenses due to the reasons stated above.
+Added: We recorded a gain of $.07 million for the nine months ended September 30, 2021 associated with the forgiveness of the PPP Loan.
+Added: Net loss was $10.1 million for the nine months ended September 30, 2021, and $3.5 million for the nine months ended September 30, 2020, an increase of $6.6 million, primarily due to the reasons stated above.
Liquidity and Capital Resources
−Removed: Since inception, we have generated no revenue from operations and we have incurred cumulative losses of approximately $19.3 million since inception as of June 30, 2021.
+Added: Since inception, we have generated no revenue from operations and we have incurred cumulative losses of approximately $23.9 million since inception as of September 30, 2021.
We have funded our operations primarily from equity issuances.
−Removed: We received net cash proceeds of approximately $12.9 million from equity financings closed between March 2018 and October 2020 On June 29, 2021, we completed our IPO resulting in net proceeds of approximately $14.8 million after deducting underwriter discounts of $1.4 million and offering costs of approximately $1.1 million.
+Added: We received net cash proceeds of approximately $12.9 million from equity financings closed between March 2018 and October 2020.
+Added: On June 29, 2021, we completed our IPO resulting in net proceeds of approximately $14.8 million after deducting underwriter discounts of $1.4 million and offering costs of approximately $1.1 million.
Based upon our lack of revenue expected for the foreseeable future, and because of numerous risks and uncertainties associated with the research, development and future commercialization of our product candidates, we are unable to estimate with certainty the amounts of increased capital outlays and operating expenditures associated with our anticipated clinical trials and development activities.
−Removed: These conditions raise substantial doubt about our ability to continue as a going concern within two years after the date that the financial statements included in this Quarterly Report on Form 10-Q were issued.
−Removed: We may see to raise capital through private or public equity offerings, debt financings, collaborations, other out-licensing arrangements, strategic alliances, federal and private grants, marketing, other distribution or licensing arrangements, or the sale of current or future assets.
+Added: These conditions raise substantial doubt about our ability to continue as a going concern within one year after the date that the financial statements included in this Quarterly Report on Form 10-Q were issued.
+Added: We may seek to raise capital through private or public equity offerings, debt financings, collaborations, other out-licensing arrangements, strategic alliances, federal and private grants, marketing, other distribution or licensing arrangements, or the sale of current or future assets.
If we raise additional funds through collaborations, strategic alliances or licensing arrangements with third parties, we might have to relinquish valuable rights to our technologies, future revenue streams, research programs or product candidates.
If we are not able to secure adequate additional funding, we may be forced to make reductions in spending, extend payment terms with suppliers, liquidate assets where possible or suspend or curtail planned programs.
−Removed: Due to the uncertainty regarding future financings and/or other potential options to raise additional funds, management has concluded that substantial doubt exists with respect to the our ability to continue as a going concern within one year after the date that the financial statements in this Quarterly Report on Form 10-Q were issued.
−Removed: As of June 30, 2021, we had working capital of $15.5 million, consisting primarily of $17.1 million of cash, offset by $1.9 million of accounts payable and accrued expenses.
+Added: Due to the uncertainty regarding future financings and/or other potential options to raise additional funds, management has concluded that substantial doubt exists with respect to our ability to continue as a going concern within one year after the date that the financial statements in this Quarterly Report on Form 10-Q were issued.
+Added: As of September 30, 2021, we had working capital of $14.3 million, consisting primarily of $14.5 million of cash, offset by $0.7 million of accounts payable and accrued expenses.
The following table sets forth selected cash flow information for the periods indicated:
−Removed: For the six months ended
+Added: For the nine months ended
+Added: September 30,
Net cash used in operating activities
Net cash provided by financing activities
−Removed: Net increase (decrease) in cash
+Added: Net increase in cash
Net Cash Used in Operating Activities
−Removed: Net cash used in operating activities was $0.9 million for the six months ended June 30, 2021.
−Removed: The net loss was greater than the net cash used in operating activities by $4.6 million, primarily attributable to share-based compensation of $3.4 million and an increase in accounts payable of $1.5 million, offset by an increase in prepaid expenses of $0.3 million.
−Removed: Net cash used in operating activities was $1.6 million for the six months ended June 30, 2020.
−Removed: The net loss was greater than the net cash used in operating activities by $0.6 million, primarily attributable to share-based compensation of $1.5 million, offset by a decrease in accounts payable of $0.9 million.
+Added: Net cash used in operating activities was $3.5 million for the nine months ended September 30, 2021.
+Added: The net loss was greater than the net cash used in operating activities by $6.6 million, primarily attributable to share-based compensation and share-based vendor payments of $6.9 million, an increase in accounts payable of $0.2 million, offset by an increase in prepaid expenses of $0.5 million.
+Added: Net cash used in operating activities was $2.4 million for the nine months ended September 30, 2020.
+Added: The net loss was greater than the net cash used in operating activities by $1.1 million, primarily attributable to share-based compensation and shared-based vendor payments of $1.8 million, offset by a decrease in accounts payable of $0.7 million.
Net Cash Used in Financing Activities
−Removed: Net cash provided by financing activities was $14.8 million for the six months ended June 30, 2021, which was attributable to the net proceeds from the Company’s IPO.
−Removed: Net cash provided by financing activities was $1.1 million for the six months ended June 30, 2020, which was primarily attributable to the net proceeds from the Company’s private placement offerings.
+Added: Net cash provided by financing activities was $14.8 million for the nine months ended September 30, 2021, which was attributable to the net proceeds from the Company’s IPO.
+Added: Net cash provided by financing activities was $3.3 million for the nine months ended September 30, 2020, which was primarily attributable to the net proceeds from the Company’s private placement offerings.
Critical Accounting Policies and Estimates
7 unchanged sentences
Federal Income Taxes
−Removed: The Company estimates an annual effective tax rate of 0% as the Company incurred losses for the six months ended June 30, 2021 and is forecasting additional losses through year-end, resulting in an estimated net loss for both financial statement and tax purposes.
+Added: The Company estimates an annual effective tax rate of 0% as the Company incurred losses for the nine months ended September 30, 2021 and is forecasting additional losses through year-end, resulting in an estimated net loss for both financial statement and tax purposes.
Therefore, no current federal or state income tax expense has been recorded in the financial statements.
10 unchanged sentences
At times, the cash balance may exceed the maximum insured limit of the FDIC.
+Added: As of September 30, 2021, the Company had cash of $14.5 million in U.S.
+Added: bank accounts which were not fully insured by the FDIC.
Guaranteed Payments to Members
5 unchanged sentences
These amounts are deferred and expensed in the period the service is provided.
−Removed: We incurred net research and development expenses in the amount of $2,202,979 and $3,510,088 for the years ended December 31, 2020 and 2019, respectively, and $186,981 and $1,085,469 for the six months ended June 30, 2021 and 2020, respectively.
+Added: We incurred net research and development expenses in the amount of $2,202,979 and $3,510,088 for the years ended December 31, 2020 and 2019, respectively, and $1,313,954 and $1,745,446 for the nine months ended September 30, 2021 and 2020, respectively.
Share-Based Compensation
23 unchanged sentences
In addition, we intend to rely on the other exemptions and reduced reporting requirements provided by the JOBS Act.
−Removed: Subject to certain conditions set forth in the JOBS Act, we are entitled to rely on certain exemptions as an emerging growth company, we are not required to, among other things, (i) provide an auditor’s attestation report on our system of internal controls over financial reporting pursuant to Section 404(b), (ii) provide all of the compensation disclosure that may be required of non-emerging growth public companies under the Dodd-Frank Wall Street Reform and Consumer Protection Act, (iii) comply with any requirement that may be adopted by the Public Company Accounting Oversight Board regarding mandatory audit firm rotation or a supplement to the auditor’s report providing additional information about the audit and the financial statements (auditor discussion and analysis), and (iv) disclose certain executive compensation-related items.
+Added: Subject to certain conditions set forth in the JOBS Act, we are entitled to rely on certain exemptions as an emerging growth company;
+Added: we are not required to, among other things, (i) provide an auditor’s attestation report on our system of internal controls over financial reporting pursuant to Section 404(b), (ii) provide all of the compensation disclosure that may be required of non-emerging growth public companies under the Dodd-Frank Wall Street Reform and Consumer Protection Act, (iii) comply with any requirement that may be adopted by the Public Company Accounting Oversight Board regarding mandatory audit firm rotation or a supplement to the auditor’s report providing additional information about the audit and the financial statements (auditor discussion and analysis), and (iv) disclose certain executive compensation-related items.
These exemptions will apply for a period of five years following the completion of our IPO or until we no longer meet the requirements of being an emerging growth company, whichever is earlier.
Recent Accounting Pronouncements
−Removed: The Financial Accounting Standards Board has issued certain accounting pronouncements as of June 30, 2021 that will become effective in subsequent periods;
+Added: The Financial Accounting Standards Board has issued certain accounting pronouncements as of September 30, 2021 that will become effective in subsequent periods;
however, we do not believe that any of those pronouncements would have significantly affected our financial accounting measurements or disclosures had they been in effect during 2021, or that they will have a significant impact on us at the time they become effective.
2 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.