What changed in this filing

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Item 2. Management’s Discussion and Analysis

2026-08-13 compared with 2026-05-11 · 65 added, 35 removed, 204 unchanged (33% of the section changed)

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New data presented at IDWeek in October 2025 demonstrated that representative novel compounds from our DNA pol IIIC inhibitor preclinical pipeline provide initial evidence that microbiome selectivity, when compared to the comparator antibiotic, linezolid, may be a class effect.

As of March 31, 2026, we had cash of approximately $9.3 million.

Recent Developments

April 2026 Registered Direct Offering and Concurrent Private Placement

On April 15, 2026, we entered into a Securities Purchase Agreement (the “Purchase Agreement”) with the investors named therein (the “Investors”), pursuant to which we agreed to issue and sell, in a registered direct offering by us directly to the Investors (the “April 2026 Registered Offering”) (i) 816,068 shares of common stock, par value $0.001 per share, of the Company (the “Common Stock”) at a purchase price of $3.03 per share and (ii) pre-funded common stock purchase warrants to purchase up to 9,017 shares of Common Stock at a purchase price of $3.029 per share for aggregate gross proceeds of approximately $2.5 million, before deducting the placement agent fees and related offering expenses.

(the “April 2026 Registered Offering”) (i) 816,068 shares of common stock, par value $0.001 per share, of the Company (the “Common Stock”) at a purchase price of $3.03 per share and (ii) pre-funded common stock purchase warrants to purchase up to 9,017 shares of Common Stock at a purchase price of $3.029 per share for aggregate gross proceeds of approximately $2.5 million, before deducting the placement agent fees and related offering expenses.

We intend to use the net proceeds from the offering for working capital and other general corporate purposes.

In a concurrent private placement to the April 2026 Registered Offering, the Company issued unregistered short-term warrants to purchase up to 1,650,170 shares of Common stock.

The short-term warrants have an exercise price of $2.78 per share, were immediately exercisable upon issuance and will expire twenty-four months following the effective date of the registration statement registering the resale of the share of common stock underlying the short-term warrants.

Pursuant to the terms of the Purchase Agreement, the Company agreed to use commercially reasonable efforts to cause a registration statement on Form S-1 providing for the resale by holders of shares of its Common Stock issuable upon the exercise of the short-term warrants, to become effective within 60 calendar days following the date of the Purchase Agreement (or within 90 calendar days following the date of the Purchase Agreement in case of a “full review” by the Commission) and to keep such registration statement effective at all times until the Investors do not own any short-term warrants or shares of Common Stock issuable upon exercise thereof.

In a concurrent private placement to the April 2026 Registered Offering, the Company issued unregistered 24 month term warrants to purchase up to 1,650,170 shares of Common stock.

These warrants have an exercise price of $2.78 per share, were immediately exercisable upon issuance and will expire on May 11, 2028.

Ibezapolstat Program Clinical Development

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The initiative includes an open label pilot trial in multiply recurrent CDI that will enroll up to 20 patients who have experienced at least two recurrences within the past 12 months.

Trial start up activities are scheduled to begin later this month, and first patient enrollment is expected in the fourth quarter of this year.

Trial start up activities began in the second quarter, and first patient enrollment is expected in the fourth quarter of this year.

The Company intends to use data from this 20 patient study to inform the design of a planned active controlled Phase 3 registration trial in rCDI.

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In addition, we met the minimum stockholders’ equity threshold of $2.5 million under Listing Rule 5550(b)(1).

We are now in full compliance with all Nasdaq continued listing requirements and our common stock will remain listed and traded on the Nasdaq Stock Market.

We are now in full compliance with all Nasdaq continued listing requirements and our common stock is currently listed and traded on the Nasdaq Stock Market.

The Lincoln Park Transaction

On May 8, 2025, we entered into a purchase agreement (the “Lincoln Park Purchase Agreement”) with Lincoln Park Capital Fund (“Lincoln Park”), pursuant to which Lincoln Park agreed to purchase from us up to an aggregate of $12.0 million of our common stock (subject to certain limitations) from time to time over the term of the Lincoln Park Purchase Agreement (of which an aggregate of $8.7 million of shares of common stock have already been issued and sold to Lincoln Park) (the “ELOC”).

Pursuant to the Lincoln Park

Purchase Agreement, we issued 44,963 shares of common stock to Lincoln Park as a fee for making its irrevocable commitment to purchase our common stock under the Lincoln Park Purchase Agreement (the “Commitment Shares”).

Pursuant to the Lincoln Park Purchase Agreement, we issued 44,963 shares of common stock to Lincoln Park as a fee for making its irrevocable commitment to purchase our common stock under the Lincoln Park Purchase Agreement (the “Commitment Shares”).

Also on May 8, 2025, we entered into a registration rights agreement with Lincoln Park (the “Registration Rights Agreement”), pursuant to which we filed with the SEC a registration statement (the “First Registration Statement”) on Form S-1 (Registration No.

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333-290968) to register up to 585,000 shares of common stock.

On February 2, 2026, we filed with the SEC a registration statement (the “Third Registration Statement and, together with the First Registration Statement and the Second Registration Statement, the “Prior Registration Statements”) on Form S-1 (Registration No.

On February 2, 2026, we filed with the SEC a registration statement (the “Third Registration Statement” on Form S-1 (Registration No.

333-293136) to register up to 750,000 shares of common stock.

On May 4, 2026, we filed with the SEC a registration statement (the “Fourth Registration Statement” and, together with the First Registration Statement and the

Second Registration Statement and the Third Registration Statement, the “Prior Registration Statements”) on Form S-1 (Registration No.

333-295527) to register up to 1,300,000 shares of common stock.

To date, we have issued and sold 2,754,359 shares of common stock pursuant to the Prior Registration Statements for aggregate gross proceeds of $8.7 million.

Nasdaq Market Value of Listed Securities Requirement

On July 22, 2026, the Securities and Exchange Commission (“SEC”) issued an order approving Nasdaq’s new rules requiring listed companies to maintain a Market Value of Listed Securities (“MVLS”) of at least $5 million.

Under the new rules, every company listed on the Nasdaq Global Select Market, Nasdaq Global Market, or Nasdaq Capital Market must now maintain an MVLS of at least $5 million as an ongoing condition of listing.

This requirement applies across all three Nasdaq tiers.

If a company’s MVLS falls below $5 million for 30 consecutive business days, Nasdaq staff will issue a staff delisting determination, the company’s securities will be immediately suspended from trading and delisting proceedings will commence.

Shares will then generally begin trading on the over-the-counter market.

Unlike certain other continued listing deficiencies (which afford companies an opportunity to submit a compliance plan or benefit from a cure period), the MVLS requirement provides no such relief.

A timely request for a hearing before the Nasdaq Hearings Panel will not automatically stay the suspension of trading.

The Hearings Panel may, in its discretion:

(a) reverse the delisting determination only if it was made in error, or (b) grant an exception of up to 180 days for the company to demonstrate compliance with Nasdaq’s initial listing standards (which are generally higher than continued listing standards).

An adverse decision may be further appealed to the Nasdaq Listing and Hearing Review Council.

On July 29, 2026, the SEC stayed the new $5 million MVLS requirement pending further review.

Effects of Coronavirus (COVID-19) on Our Business

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General and administrative expenses consist primarily of salaries and employee-related costs, including share-based compensation, for personnel in our executive, finance and other administrative functions.

Other significant costs include facility-related costs, legal fees relating to intellectual property and corporate matters, professional fees for accounting and consulting services and insurance costs.

Other significant costs include facility-related costs, legal fees relating to intellectual property and corporate matters, professional fees for accounting and consulting services

and insurance costs.

We anticipate that our general and administrative expenses will increase in the future to support our continued research and development activities, pre-commercialization and, if any product candidates receive marketing approval, commercialization activities.

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Results of Operations

Three Months Ended March 31, 2026 Compared to the Three Months Ended March 31, 2025

The following table presents a summary of the changes in our results of operations for the three months ended March 31, 2026 compared with the three months ended March 31, 2025:

Three Months Ended June 30, 2026 Compared to the Three Months Ended June 30, 2025

The following table presents a summary of the changes in our results of operations for the three months ended June 30, 2026 compared with the three months ended June 30, 2025:

Three Months Ended

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Research and Development Expenses

Research and development expenses were $0.3 million for the three months ended March 31, 2026 and $0.6 million for the three months ended March 31, 2025, a decrease of $0.3 million due to $0.1 million decrease in manufacturing related costs and $0.2 million decrease in consulting fees as the prior year had higher expenses related to Phase 2b and Phase 3 preparation costs.

Research and development expenses were $1.1 million for the three months ended June 30, 2026 and $0.5 million for the three months ended June 30, 2025, an increase of $0.6 million due to $0.3 million increase in manufacturing related costs and $0.3 million increase in consulting fees as a result of costs associated with new recurrent CDI trial program.

General and Administrative Expenses

General and administrative expenses were $1.4 million for the three months ended March 31, 2026 and $1.6 million for the three months ended March 31, 2025, a decrease of $0.2 million .

The decrease was primarily due to $0.1 million decrease in professional fees and $0.1 million decrease in legal fees.

Net loss was $1.7 million for the three months ended March 31, 2026, and $2.1 million for the three months ended March 31, 2025, a decrease of $0.4 million, due to the reasons stated above.

General and administrative expenses were $1.2 million for the three months ended June 30, 2026 and $1.7 million for the three months ended June 30, 2025, a decrease of $0.5 million .

The decrease was primarily due to a $0.3 million decrease in professional fees, a $0.1 million decrease in legal fees and a $0.1 million decrease in share-based compensation expense.

Net loss was $2.3 million and $2.2 million for the three months ended June 30, 2026, and 2025, respectively.

Six Months Ended June 30, 2026 Compared to the Six Months Ended June 30, 2025

The following table presents a summary of the changes in our results of operations for the six months ended June 30, 2026 compared with the six months ended June 30, 2025:

Six Months Ended

(in thousands)

OPERATING EXPENSES:

Research and Development

General and Administrative

TOTAL OPERATING EXPENSES

OPERATING LOSS

Interest Income

Research and Development Expenses

Research and development expenses were $1.4 million for the six months ended June 30, 2026 and $1.1 million for the six months ended June 30, 2025, an increase of $0.3 million primarily due to $0.1 million increase in consulting fees and $0.2 increase in manufacturing related costs as a result of costs associated with new recurrent CDI trial program.

General and Administrative Expenses

General and administrative expenses were $2.6 million for the six months ended June 30, 2026 and $3.3 million for the six months ended June 30, 2025, a decrease of $0.7 million.

The decrease was primarily due to $0.3 million decrease in professional fees, $0.2 million in legal fees and $0.2 million decrease in share-based compensation related costs.

Net loss was $3.9 million for the six months ended June 30, 2026 and $4.4 million for the six months ended June 30, 2025, a decrease of $0.5 million, due to the reasons stated above.

Liquidity and Capital Resources

Since inception, we have generated no revenue from operations and we have incurred cumulative losses of approximately $77.0 million as of March 31, 2026 .

Since inception, we have generated no revenue from operations and we have incurred cumulative losses of approximately $79.2 million as of June 30, 2026 .

We have funded our operations primarily from equity issuances.

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On November 15, 2023, we entered into a Sales Agreement and established an “At-the-Market” 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 (the “ATM Program”) .

Under the ATM Program, we raised net proceeds of approximately $ 8.8

million after deducting sales agent commissions and other related expenses of $0.4 million.

Under the ATM Program, we raised net proceeds of approximately $ 8.8 million after deducting sales agent commissions and other related expenses of $0.4 million.

As of January 6, 2025, we suspended the ATM Program.

In January 2025, we completed a registered direct offering and concurrent private placement for net proceeds of $2.1 million after deducting placement agent fees and offering expenses.

In January 2025, we completed a registered direct offering and concurrent private placement for net proceeds of $2.1

million after deducting placement agent fees and offering expenses.

In March 2025, we completed a registered direct offering and concurrent private placement for net proceeds of $0.9 million after deducting placement agent fees and offering expenses.

On May 8, 2025, we entered into the ELOC with Lincoln Park, pursuant to which Lincoln Park committed to purchase up to $12.0 million in shares of our common stock.

Under the ELOC, we raised net proceeds of approximately $ 6.9 million after deducting related fees and expenses as of March 31, 2026.

Under the ELOC, we raised net proceeds of approximately $ 7.8 million after deducting related fees and expenses as of June 30, 2026.

On June 17, 2025, we entered into a warrant inducement agreement with existing warrant holders, receiving net proceeds of approximately $2.5 million after deducting fees and transaction expenses.

In April 2026, we completed a registered direct offering and concurrent private placement for net proceeds of approximately $2.3 million after deducting placement agent fees and offering expenses.

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.

As of March 31, 2026, we had working capital of $7.0 million, consisting primarily of $9.3 million of cash and $0.3 million of prepaid expenses and other receivable, offset by approximately $2.5 million of accounts payable and accrued expenses.

As of June 30, 2026, we had working capital of $8.2 million, consisting primarily of $10.7 million of cash and $0.3 million of prepaid expenses and other receivable, offset by approximately $2.8 million of accounts payable and accrued expenses.

The following table sets forth selected cash flow information for the periods indicated:

Three Months Ended

Six Months Ended

(in thousands)

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Net Cash Used in Operating Activities

Net cash used in operating activities was $1.4 million for the three months ended March 31, 2026.

The net loss was greater than the net cash used in operating activities by $0.3 million, primarily attributable to share-based compensation and share-based vendor payments of $0.3 million.

Net cash used in operating activities was $2.1 million for the three months ended March 31, 2025.

The net loss was greater than the net cash used in operating activities by $0.1 million, primarily attributable to share-based compensation and share-based vendor payments of $0.4 million offset by a decrease in accounts payable and accrued expenses of $0.3 million.

Net cash used in operating activities was $3.1 million for the six months ended June 30, 2026.

The net loss was greater than the net cash used in operating activities by $0.8 million, primarily attributable to share-based compensation and share-based vendor payments of $0.6 million and increase in accounts payable and accrued expenses of $0.4 million, offset by increase in other receivable and prepaid expenses of $0.2 million.

Net cash used in operating activities was $3.7 million for the six months ended June 30, 2025.

The net loss was greater than the net cash used in operating activities by $0.7 million, primarily attributable to share-based compensation and share-based vendor payments of $0.9 million offset by decrease in accounts payable and accrued expenses of $0.2 million.

Net Cash Provided by Financing Activities

Net cash provided from financing activities was $3.1 million for the three months ended March 31, 2026, which was attributable to the sales related to the equity line of credit purchase agreement.

Net cash provided from financing activities was $3.0 million for the three months ended March 31, 2025, which was primarily attributable to the net proceeds from the January 2025 and March 2025 Registered Direct Offerings (as defined in Note-4 to our condensed interim financial statements contained in Item 1 of this Quarterly Report on Form 10-Q).

Net cash provided from financing activities was $6.2 million for the six months ended June 30, 2026, which was attributable to the sales related to the equity line of credit purchase agreement and the April 2026 Registered Direct Offering (as defined in Note-4 to our condensed interim financial statements contained in Item 1 of this Quarterly Report on Form 10-Q).

Net cash provided from financing activities was $6.1 million for the six months ended June 30, 2025, which was attributable to the net proceeds from the January and March Registered Direct Offerings, 2025 warrant exercise and sales related to the equity line of credit purchase agreement.

Critical Accounting Policies and Estimates

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The preparation of these financial statements requires us to make estimates and judgments that affect the reported amounts of assets, liabilities, revenues and expenses and the disclosure of contingent assets and liabilities in our financial statements.

On an ongoing basis, we evaluate our estimates and judgments, including those related to accrued expenses and share-based compensation.

We base our estimates on historical experience, known trends and events, and various other factors that we believe to be reasonable under the circumstances, the

results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources.

On an ongoing basis, we evaluate our

estimates and judgments, including those related to accrued expenses and share-based compensation.

We base our estimates on historical experience, known trends and events, and various other factors that we believe to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources.

Our actual results may differ from these estimates under different assumptions or conditions.

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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.

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.

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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.

What changed 10-Q

Item 2. Management’s Discussion and Analysis