Acurx Pharmaceuticals Inc
For the period ended Jun 30, 2024. Filed Aug 8, 2024.
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A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Jun 30, 2024 · Filed Aug 8, 2024
ACXP$1.06+12.1%Stored close · as of Nov 6, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2024-03-31; filed 2024-05-14.
0001558370-24-008130
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2024-06-30; filed 2024-08-08.
0001558370-24-011587
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
Compared 90 previous paragraphs and 91 current paragraphs.
66 unchanged; 11 reworded; 12 added; 11 removed; 2 previous and 2 current paragraphs rearranged.
Tables are not compared: 23 previous and 24 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 (12)
Current report
We convened an End-of-Phase 2 Meeting with the FDA on April 17, 2024 and announced on May 15, 2024 that we had a successful meeting, including confirmation of Phase 3 readiness for ibezapolstat for the treatment ofC. difficile infection. Agreement with the FDA was reached on key elements to move forward with our international Phase 3 clinical trial program. Agreement was also reached with the FDA on the complete non-clinical and clinical development plan for filing of a New Drug Application (“NDA”) for marketing approval. Planning continues to advance ibezapolstat into international Phase 3 clinical trials for treatment ofC. difficileinfection (“CDI”). We are also now preparing to submit requests for guidance to initiate clinical trials in the European Union, the United Kingdom, Japan and Canada, as well as preparing for a manufacturing meeting with the FDA to be scheduled prior to Phase 3 enrollment.
Current report
In July 2024, we announced that a new patent has been granted by the United States Patent and Trademark Office (“USPTO”). This patent relates to ibezapolstat and its use to treatC. difficile infection while reducing the recurrence of the infection, as well as improving the health of the gut microbiome. This is the latest in the series of granted patents and pending patent applications that we have filed to protect our proprietary technologies in the field of antimicrobials.
Current report
Following our successful End-of-Phase 2 Meeting with the FDA, which confirmed our Phase 3 clinical trial readiness, and per the FDA regulatory requirements, in August 2024, we submitted our request to the FDA for a meeting to review our manufacturing processes and specifications for drug substance and final project and packaging (typically referred to as Chemistry, Manufacturing and Controls (“CMC”)) for our Phase 3 clinical trials. We anticipate the FDA to grant a meeting in the fourth quarter.
Current report
Six Months Ended June 30, 2024 Compared to the Six Months Ended June 30, 2023
Current report
Research and development expenses were $3.4 million for the six months ended June 30, 2024 and $2.8 million for the six months ended June 30, 2023, an increase of $0.6 million primarily due to $0.8 million increase in manufacturing related costs offset by $0.2 million decrease in consulting fees.
Current report
General and administrative expenses were $5.1 million for the six months ended June 30, 2024 and $3.6 million for the six months ended June 30, 2023, an increase of $1.5 million. The increase was primarily due to $1.0 million increase in professional fees, $0.4 million increase in share-based compensation costs and $0.1 million increase in legal costs.
Current report
Net Loss
Current report
Net loss was $8.5 million for the six months ended June 30, 2024, and $6.3 million for the six months ended June 30, 2023, an increase of $2.2 million, due to the reasons stated above.
Current report
payments of $1.7 million and increase in accounts payable and accrued expenses of $0.9 million and decrease in prepaid expenses of $0.2 million.
Current report
Net cash provided from financing activities was $3.5 million for the six months ended June 30, 2023, which was attributable to the net proceeds from the registered direct offering.
Current report
Recent Accounting Pronouncements not yet adopted
Current report
In December 2023, the FASB issued ASU 2023-09,Income Taxes (Topic 740): Improvements to Income Tax Disclosures, which expands the disclosures required for income taxes. This ASU is effective for fiscal years beginning after December 15, 2024, with early adoption permitted. The amendment should be applied on a prospective basis while retrospective application is permitted. The Company is currently evaluating the effect of this pronouncement on its disclosures.
Removed paragraphs (11)
Previous report
Completion ofthe Phase 2b Segment of our Phase 2 Clinical Trial
Previous report
On October 2, 2023, we discontinued the Phase 2b segment of our clinical trial of our lead antibiotic candidate, ibezapolstat, targeting the treatment of patients with CDI and weanticipate advancing to Phase 3 clinical trials more expeditiously than originally planned. We made the decision to discontinue the Phase 2bsegment of ourclinical trial in consultation with our medical and scientific advisors and statisticians based upon observed aggregate blinded data and other factors, including the cost to maintain clinical trial sites and slow enrollment due to COVID-19.
Previous report
We determined that the Phase 2b segment of ourclinical trial performed as anticipated for each of ibezapolstat, our lead antibiotic candidate, and vancomycin, the control agent and a standard of care to treat patients with CDI, with high rates of clinical cure observed across the trial and no emerging safety concerns reported to date. Accordingly, the Independent Data Monitoring Committee was not required to perform an interim analysis of the Phase 2b clinical trial data as originally planned but was supportive of our decision to discontinue the Phase 2b segment of our clinical trial early and will remain involved for our Phase 3 clinical trials. Prior to discontinuing the Phase 2b clinical trial, we notified FDA of our decision to early discontinue the trial. The trial was not discontinued due to safety concerns.
Previous report
We convened an End-of-Phase 2 Meeting with FDA in April 2024 and expect to report the results of the FDA meeting as soon as the Company receives final meeting minutes from FDA which we anticipate in May 2024.
Previous report
Research and Development Expenses
Previous report
General and Administrative Expenses
Previous report
Research and Development Expenses
Previous report
General and Administrative Expenses
Previous report
There was no cash provided from financing activities for the three months ended March 31, 2023.
Previous report
Recent Accounting Pronouncements
Previous report
The Financial Accounting Standards Board has issued certain accounting pronouncements as of March 31, 2024 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, or that they will have a significant impact on us at the time they become effective.
Reworded paragraphs (11)
Previous wording
As of the period ended March 31, 2024, we sold a total of 1,819,914 shares of our common stock under the ATM Program at a weighted-average price of $3.88 per share, raising $7.1 million of gross proceeds and net proceeds of $6.7 million, after deducting commissions to the sales agent and other ATM Program related expenses. There remains approximately $9.9 million available for future sales of shares of common stock under the ATM Program.
Current wording
As of the period ended June 30, 2024, we sold a total of 1,952,980 shares of our common stock under the ATM Program at a weighted-average price of $3.78 per share, raising $7.4 million of gross proceeds and net proceeds of $7.0 million, after deducting commissions to the sales agent and other ATM Program related expenses. As of August 7, 2024, total sales under the ATM Program since it was implemented in November 2023 are approximately $8.0 million out of the total $17 million ATM facility.
Previous wording
Research and development expenses were $1.6 million for the three months ended March 31, 2024 and $1.0 million for the three months ended March 31, 2023, an increase of $0.6 million primarily due to increase in manufacturing related costs.
Current wording
Research and development expenses were $1.8 million for the three months ended June 30, 2024 and $1.7 million for the three months ended June 30, 2023, an increase of $0.1 million primarily due to $0.4 million increase in manufacturing related costs offset by $0.3 million decrease in consulting fees.
Previous wording
General and administrative expenses were $2.8 million for the three months ended March 31, 2024 and $1.9 million for the three months ended March 31, 2023, an increase of $0.9 million. The increase was primarily due to $0.7 million increase in professional fees and $0.2 million increase in share-based compensation costs.
Current wording
General and administrative expenses were $2.3 million for the three months ended June 30, 2024 and $1.7 million for the three months ended June 30, 2023, an increase of $0.6 million. The increase was primarily due to $0.3 million increase in professional fees and $0.2 million increase in share-based compensation related costs.
Previous wording
Net loss was $4.4 million for the three months ended March 31, 2024, and $2.9 million for the three months ended March 31, 2023, an increase of $1.5 million, due to the reasons stated above.
Current wording
Net loss was $4.1 million for the three months ended June 30, 2024, and $3.4 million for the three months ended June 30, 2023, an increase of $0.7 million, due to the reasons stated above.
Previous wording
Since inception, we have generated no revenue from operations and we have incurred cumulative losses of approximately $57.6 million as of March 31, 2024. We have funded our operations primarily from equity issuances. 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. On July 27, 2022, we completed a registered direct offering and concurrent private placement resulting in net proceeds of approximately $3.7 million after deducting placement agents fees of $0.3 million and offering costs of $0.2 million. On May 18, 2023, we completed a registered direct offering and a concurrent private placement resulting in net proceeds of approximately $3.5 million after deducting placement agents fee of $0.2 million and offering costs of $0.2 million. On November 15, 2023, we entered into a Sales Agreement and established the ATM Program, pursuant to which we may offer and sell, from time to time, through A.G.P./Alliance Global Partners, as sales agent, shares of our common stock having an aggregate offering price of up to $17.0 million. Under the ATM Program, we raised net proceeds of approximately $6.7 million after deducting sales agent commissions and other related expenses of $0.2 million.
Current wording
Since inception, we have generated no revenue from operations and we have incurred cumulative losses of approximately $61.7 million as of June 30, 2024. We have funded our operations primarily from equity issuances. 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. On July 27, 2022, we completed a registered direct offering and concurrent private placement resulting in net proceeds of approximately $3.7 million after deducting placement agents fees of $0.3 million and offering costs of $0.2 million. On May 18, 2023, we completed a registered direct offering and a concurrent private placement resulting in net proceeds of approximately $3.5 million after deducting placement agents fee of $0.2 million and offering costs of $0.2 million. On November 15, 2023, we entered into a Sales Agreement and established the ATM Program, pursuant to which we may offer and sell, from time to time, through A.G.P./Alliance Global Partners, as sales agent, shares of our common stock having an aggregate offering price of up to $17.0 million. Under the ATM Program, we raised net proceeds of approximately $7.0 million after deducting sales agent commissions and other related expenses of $0.4 million.
Previous wording
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
Current wording
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.
Previous wording
As of March 31, 2024, we had working capital of $6.0 million, consisting primarily of $8.9 million of cash and $0.2 million of prepaid expenses, offset by $3.1 million of accounts payable and accrued expenses.
Current wording
As of June 30, 2024, we had working capital of $3.4 million, consisting primarily of $6.4 million of cash, $0.2 million of other receivable and prepaid expenses, offset by approximately $3.2 million of accounts payable and accrued expenses.
Previous wording
Net cash used in operating activities was $3.1 million for the three months ended March 31, 2024. The net loss was greater than the net cash used in operating activities by $1.3 million, primarily attributable to share-based compensation and share-based vendor payments of $1.2 million.
Current wording
Net cash used in operating activities was $5.9 million for the six months ended June 30, 2024. The net loss was greater than the net cash used in operating activities by $2.6 million, primarily attributable to share-based compensation and share-based vendor payments of $2.4 million.
Previous wording
Net cash used in operating activities was $1.9 million for the three months ended March 31, 2023. The net loss was greater than the net cash used in operating activities by $1.0 million, primarily attributable to share-based compensation and share-based vendor payments of $0.9 million.
Current wording
Net cash used in operating activities was $3.5 million for the six months ended June 30, 2023. The net loss was greater than the net cash used in operating activities by $2.8 million, primarily attributable to share-based compensation and share-based vendor
Previous wording
Net cash provided from financing activities was $4.5 million for the three months ended March 31, 2024, which was primarily attributable to the ATM Program.
Current wording
Net cash provided from financing activities was $4.8 million for the six months ended June 30, 2024, which was primarily attributable to the ATM Program.
Previous wording
Costs for certain research and development activities, such as the provision of services for clinical trial activity, are estimated based on an evaluation of the progress to completion of specific tasks which may use data such as subject enrollment, clinical site activations or information provided to us by our vendors with respect to their actual costs incurred. Payments for these activities are based on the terms of the individual arrangements, which may differ from the pattern of costs incurred, and are reflected in the financial statements as prepaid or accrued research and development expense, as applicable. The estimates are adjusted to reflect the
Current wording
Costs for certain research and development activities, such as the provision of services for clinical trial activity, are estimated based on an evaluation of the progress to completion of specific tasks which may use data such as subject enrollment, clinical site activations or information provided to us by our vendors with respect to their actual costs incurred. Payments for these activities are based on the terms of the individual arrangements, which may differ from the pattern of costs incurred, and are reflected in the financial statements as prepaid or accrued research and development expense, as applicable. The estimates are adjusted to reflect the best information available at the time of the financial statement issuance. Although we do not expect our estimates to be materially different from amounts actually incurred, our estimate of the status and timing of services performed relative to the actual status and timing of services performed may vary.
Rearranged current paragraphs (2)
Current report — wording carried from elsewhere
There remains approximately $9.0 million available for future sales of shares of common stock under the ATM Program.
Current report — wording carried from elsewhere
The following table presents a summary of the changes in our results of operations for the six months ended June 30, 2024 compared with the six months ended June 30, 2023:
Rearranged previous paragraphs (2)
Previous report — wording carried elsewhere
certainty the amounts of increased capital outlays and operating expenditures associated with our anticipated clinical trials and development activities.
Previous report — wording carried elsewhere
best information available at the time of the financial statement issuance. Although we do not expect our estimates to be materially different from amounts actually incurred, our estimate of the status and timing of services performed relative to the actual status and timing of services performed may vary.