What changed in this filing

/stocks — the workspaceLOADING

Item 2. Management’s Discussion and Analysis

2025-08-08 compared with 2025-05-08 · 39 added, 26 removed, 122 unchanged (35% of the section changed)

13 unchanged sentences

Since our inception, we have devoted substantially all of our resources to organizing and staffing our Company, business planning, raising capital, and research and development of the Product Candidates.

We have funded our operations since our inception to March 31, 2025 through the issuance and sale of our capital stock, from which we have raised net proceeds of $56.8 million.

We have funded our operations since our inception to June 30, 2025 through the issuance and sale of our capital stock, from which we have raised net proceeds of $60.2 million.

Our current cash and cash equivalents balance will not be sufficient to complete all necessary product development or future commercialization efforts.

We anticipate that our current cash and cash equivalents balance will not be sufficient to sustain operations within one-year after the date that our audited financial statements for March 31, 2025 were issued, which raises substantial doubt about our ability to continue as a going concern.

We anticipate that our current cash and cash equivalents balance will not be sufficient to sustain operations within one-year after the date that our audited financial statements for June 30, 2025 were issued, which raises substantial doubt about our ability to continue as a going concern.

We plan to seek additional funding through public or private equity or debt financings.

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If we are unable to obtain funding we could be required to delay, reduce or eliminate research and development programs, product portfolio expansion or future commercialization efforts, which could adversely affect our business operations.

We have incurred recurring losses since our inception, including a net loss of $2.1 million for the three months ended March 31, 2025 and $2.7 million for the three months ended March 31, 2024.

As of March 31, 2025 we had an accumulated deficit of $42.6 million.

We have incurred recurring losses since our inception, including a net loss of $4.5 million for the six months ended June 30, 2025 and $11.1 million for the six months ended June 30, 2024.

As of June 30, 2025 we had an accumulated deficit of $45.0 million.

We expect to continue to generate operating losses and negative operating cash flows for the foreseeable future if and as we:

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Recent Developments

2025 Reverse Stock Split

One Big Beautiful Bill Act

On July 4, 2025, the One Big Beautiful Bill Act (OBBBA) was enacted in the U.S.

The OBBBA includes significant provisions, such as the permanent extension of certain expiring provisions of the Tax Cuts and Jobs Act, modifications to the international tax framework and the restoration of favorable tax treatment for certain business provisions.

The legislation has multiple effective dates, with certain provisions effective in 2025 and others implemented through 2027.

The Company is currently assessing its impact on its consolidated financial statements, which are expected to be immaterial.

Reverse Stock Splits

On January 28, 2025, the Company effected a 1-for-16 reverse stock split of our outstanding shares of common stock, which had been approved at a special meeting of stockholders.

Additionally, on July 7, 2025, the Company effected the approved 1-for-3 reverse stock split of our shares of common stock.

Research and Development

Research and development expenses consist primarily of costs incurred for the development of our product candidates Product Candidates.

Research and development expenses consist primarily of costs incurred for the development of our product candidates.

Our research and development expenses consist primarily of external costs related to clinical development, costs related to contract research organizations, costs related to consultants, costs related to acquiring and manufacturing clinical study materials, costs related to contract manufacturing organizations and other vendors, costs related to the preparation of regulatory submissions, costs related to laboratory supplies and services, and personnel costs.

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Three Months Ended

Six Months Ended

Operating expenses:

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Three Months Ended

Six Months Ended

GEM-AKI, GEM-CKD and GEM-PSI clinical study expenses

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Total research and development expenses

Research and development expenses increased by $0.1 million, from $0.7 million for the three months ended March 31, 2024 to $0.9 million for the three months ended March 31, 2025.

Research and development expenses decreased by $0.1 million, from $1.4 million for the three months ended June 30, 2024 to $1.3 million for the three months ended June 30, 2025.

The decrease was primarily due to a decrease of other research and development expenses.

Research and development expenses increased by $0.1 million, from $2.1 million for the six months ended June 30, 2024 to $2.2 million for the six months ended June 30, 2025.

The increase was primarily due to increases of $0.1 million of clinical study expense and $0.1 million of personnel expenses, offset by a decrease of $0.1 million of other research and development expenses.

Other program expenses include pre-clinical costs and clinical preparation costs primarily for new programs.

General and Administrative Expenses

General and administrative expenses increased by $0.05 million, from $1.1 million for the three months ended March 31, 2024 to $1.2 million for the three months ended March 31, 2025.

The increase was primarily due to a increase of $0.06 million in legal and professional fees, and an increase of $0.09 million in personnel expenses.

General and administrative expenses for the three months ended June 30, 2025 and 2024 were $1.1 million for both periods.

General and administrative expenses increased by $0.1 million, from $2.3 million for the six months ended June 30, 2024 to $2.4 million for the six months ended June 30, 2025.

The increase was primarily due to increases of $0.1 million in legal and professional fees.

Other (Expense) Income, Net

Other (expense) income, net, was expense of $0.8 million for the three months ended March 31, 2024, primarily related to the change in fair value of the warrant liability, the clinical trial related settlement expenses with A-IR Clinical Research Ltd., foreign currency transaction gains and losses, and interest income from our cash balances in savings accounts.

Other (expense) income, net, was income of $0.04 million for the three months ended March 31, 2025, primarily related to the change in fair value of the warrant liability, foreign currency transaction gains and losses, and interest income from our cash balances in savings accounts.

Other (expense) income, net was expense of $5.9 million for the three months ended June 30, 2024, primarily related to the clinical trial related settlement expenses with A-IR Clinical Research Ltd., offset by interest income from our cash balances in savings accounts.

Other (expense) income, net, was minimal for the three months ended June 30, 2025.

Other (expense) income, net, was expense of $6.6 million for the six months ended June 30, 2024, primarily related to the change in fair value of the warrant liability, the clinical trial related settlement expenses with A-IR Clinical Research Ltd., foreign currency transaction gains and losses, and interest income from our cash balances in savings accounts.

Other (expense) income, net,

was income of $0.06 million for the six months ended June 30, 2025, primarily related to the change in fair value of the warrant liability, foreign currency transaction gains and losses, and interest income from our cash balances in savings accounts.

Liquidity and Capital Resources

Since our inception to March 31, 2025, we have funded our operations from the issuance and sale of our common stock, preferred stock and warrants, from which we have raised net proceeds of $56.8 million.

As of March 31, 2025, we had available cash and cash equivalents of $3.7 million and an accumulated deficit of $42.6 million.

Since our inception to June 30, 2025, we have funded our operations from the issuance and sale of our common stock, preferred stock and warrants, from which we have raised net proceeds of $60.2 million.

As of June 30, 2025, we had available cash and cash equivalents of $5.2 million and an accumulated deficit of $45.0 million.

Our use of cash is to fund operating expenses, which consist primarily of research and development expenditures related to our Product Candidates.

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Going Concern

We have incurred recurring losses since our inception, including a net loss of $2.1 million for the three months ended March 31, 2025.

As of March 31, 2025 we had an accumulated deficit of $42.6 million, a stockholders’ equity of $2.9 million and available cash and cash equivalents of $3.7 million.

We have incurred recurring losses since our inception, including a net loss of $4.5 million for the six months ended June 30, 2025.

As of June 30, 2025 we had an accumulated deficit of $45.0 million, a stockholders’ equity of $3.8 million and available cash and cash equivalents of $5.2 million.

We expect to continue to incur significant operating and net losses, as well as negative cash flows from operations, for the foreseeable future as we continue to complete all necessary product development or future commercialization efforts.

We have never generated revenue and do not expect to generate revenue from product sales unless and until we successfully complete development and obtain regulatory approval for Product Candidates or other product candidates, which we expect will not be for at least several years, if ever.

We do not anticipate that our current cash and cash equivalents balance will be sufficient to sustain operations within one-year after the date that our audited financial statements for March 31, 2025 were issued, which raises substantial doubt about our ability to continue as a going concern.

We do not anticipate that our current cash and cash equivalents balance will be sufficient to sustain operations within one-year after the date that our audited financial statements for June 30, 2025 were issued, which raises substantial doubt about our ability to continue as a going concern.

To continue as a going concern, we will need, among other things, to raise additional capital resources.

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The unaudited consolidated financial statements for March 31, 2025, have been prepared on the basis that we will continue as a going concern, and do not include any adjustments to reflect the possible future effects on the recoverability and classification of assets or the amounts and classification of liabilities that may result from the possible inability for us to continue as a going concern.

The unaudited consolidated financial statements for June 30, 2025, have been prepared on the basis that we will continue as a going concern, and do not include any adjustments to reflect the possible future effects on the recoverability and classification of assets or the amounts and classification of liabilities that may result from the possible inability for us to continue as a going concern.

The following table summarizes our cash flows for the periods presented:

Three Months Ended

Six Months Ended

Net cash used in operating activities

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Net Cash Used in Operating Activities

During the three months ended March 31, 2025, net cash used in operating activities was $2.8 million, which consisted of a net loss of $2.1 million and a net change of $0.2 million comprised of the change in fair value of the warrant liability, stock-based compensation expense and depreciation expense, offset by a net change of $1.0 million in our net operating assets and liabilities.

During the three months ended March 31, 2024, net cash used in operating activities was $2.8 million, which consisted of a net loss of $2.7 million and a net change of $0.03 million comprised of the change in fair value of the warrant liability, stock-based compensation expense and depreciation expense, offset by a net change of $0.1 million in our net operating assets and liabilities.

During the six months ended June 30, 2025, net cash used in operating activities was $4.7 million, which consisted of a net loss of $4.5 million and a net change of $0.2 million comprised of the change in fair value of the warrant liability, stock-based compensation expense and depreciation expense, offset by a net change of $0.5 million in our net operating assets and liabilities.

During the six months ended June 30, 2024, net cash used in operating activities was $5.3 million, which consisted of a net loss of $11.1 million and a net change of $0.03 million comprised of the change in fair value of the warrant liability, stock-based compensation expense and depreciation expense, offset by a net change of $5.7 million in our net operating assets and liabilities.

Net Cash Used in Investing Activities

During the three months ended March 31, 2025, there was no net cash provided by or used in investing activities consisted of the disposal of lab equipment.

During the three months ended March 31, 2024, net cash used in investing activities consisted of the purchase of lab equipment.

During the six months ended June 30, 2025, there was no net cash provided by or used in investing activities.

During the six months ended June 30, 2024, net cash used in investing activities consisted of the purchase of lab equipment.

Net Cash Provided by Financing Activities

During the three months ended March 31, 2025, there was no net cash provided by financing activities.

During the three months ended March 31, 2024, net cash provided by financing activities was $5.4 million from the February Public Offering.

During the six months ended June 30, 2025, net cash provided by financing activities was $3.4 million from the May 2025 Public Offering.

During the six months ended June 30, 2024, net cash provided by financing activities was $5.4 million from the February Public Offering.

Contractual Obligations and Other Commitments

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Off-Balance Sheet Arrangements

As of March 31, 2025, we did not have any off-balance sheet arrangements as defined in Item 303(a)(4)(ii) of Regulation S-K.

As of June 30, 2025, we did not have any off-balance sheet arrangements as defined in Item 303(a)(4)(ii) of Regulation S-K.

Quantitative and Qualitative Disclosure about Market Risk

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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