What changed in this filing

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Item 2. Management’s Discussion and Analysis

2025-11-06 compared with 2025-08-08 · 44 added, 39 removed, 122 unchanged (40% of the section changed)

8 unchanged sentences

Our current Gemini based programs consist of:

GEM-AKI, which is being developed as a potential therapy for the prevention and treatment of acute kidney injury;

GEM-CKD, which is being developed as a potential therapy for the prevention and treatment of chronic kidney disease;

GEM-AKI, which is being developed as a potential therapy for the treatment of acute kidney injury;

GEM-CKD, which is being developed as a potential therapy for the treatment of chronic kidney disease;

GEM-PSI, which is being developed for the prevention and treatment of post surgical infection;

1 unchanged sentence

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

We have funded our operations since our inception to September 30, 2025 through the issuance and sale of our capital stock, from which we have raised net proceeds of $69.2 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 June 30, 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 unaudited condensed consolidated financial statements for September 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 $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 have incurred recurring losses since our inception, including a net loss of $6.4 million for the nine months ended September 30, 2025 and $13.3 million for the nine months ended September 30, 2024.

As of September 30, 2025 we had an accumulated deficit of $46.9 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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We also anticipate increased expenses as we continue to operate as a public company, including increased expenses related to financial advisory services, audit, legal, regulatory, investor relations costs, director and officer insurance premiums associated with maintaining compliance with exchange listing and SEC requirements.

Other (Expense) Income, Net

Other (expense) income, net primarily consists of the change in fair value of warrant liability, clinical trial related settlement expenses with A-IR Clinical Research Ltd., foreign currency transaction gains and losses, interest expense and interest income from our cash balances in savings accounts.

Other Income (expense), Net

Other income (expense), net primarily consists of interest income from our cash balances in savings accounts, foreign currency transaction gains and losses, the change in fair value of warrant liability, and clinical trial related settlement expenses.

Results of Operations

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Three Months Ended

Six Months Ended

September 30,

Nine Months Ended

September 30,

Operating expenses:

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Three Months Ended

Six Months Ended

September 30,

Nine Months Ended

September 30,

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

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Total research and development expenses

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.

Research and development expenses increased by $0.1 million, from $0.8 million for the three months ended September 30, 2024 to $0.9 million for the three months ended September 30, 2025.

The increase was primarily due to an increase in clinical study expenses related to our Product Candidates.

Research and development expenses increased by $0.2 million, from $2.9 million for the nine months ended September 30, 2024 to $3.1 million for the nine months ended September 30, 2025.

The increase was due to increases in personnel expenses of $0.1 million and $0.1 million of clinical study expenses related to our Product Candidates.

General and Administrative 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 $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.

General and administrative expenses for the three months ended September 30, 2025 and 2024 were $1.0 million for each period.

General and administrative expenses increased by $0.1 million, from $3.3 million for the nine months ended September 30, 2024 to $3.4 million for the nine months ended September 30, 2025.

The increase was primarily due to an increase of $0.1 million in investor relations expense and $0.1 million in consulting fees, offset by a reduction in personnel expenses.

Other Income (Expense), Net

Other income (expense), net, was income of less than $0.1 million for the three months ended September 30, 2025 and related primarily to interest income from our cash balances in savings accounts.

Other income (expense), net, was expense of $0.4 million for the three months ended September 30, 2024, primarily related to expense in connection with the deferred underwriting

commissions, partially offset by 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 income (expense), net, was income of $0.1 million for the nine months ended September 30, 2025, primarily related to interest income from our cash balances in savings accounts and foreign currency transaction gains and losses.

Other income (expense), net, was expense of $7.1 million for the nine months ended September 30, 2024, primarily related to the LifeSci judgment expense, including reimbursement of costs, the clinical trial related settlement expenses with A-IR Clinical Research Ltd, and expense in connection with the deferred underwriting commissions, offset by interest income from our cash balances in savings accounts.

Liquidity and Capital Resources

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.

Since our inception to September 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 $69.2 million.

As of September 30, 2025, we had available cash and cash equivalents of $12.7 million and an accumulated deficit of $46.9 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 $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 have incurred recurring losses since our inception, including a net loss of $6.4 million for the nine months ended September 30, 2025.

As of September 30, 2025 we had an accumulated deficit of $46.9 million, a stockholders’ equity of $11.0 million and available cash and cash equivalents of $12.7 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 June 30, 2025 were issued, which raises substantial doubt about our ability to continue as a going concern.

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 the 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 September 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 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 unaudited condensed consolidated financial statements for September 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:

Six Months Ended

Nine Months Ended

September 30,

Net cash used in operating activities

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Net cash provided by financing activities

Net (decrease) increase in cash and cash equivalents

Net increase (decrease) in cash and cash equivalents

Net Cash Used in Operating Activities

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.

During the nine months ended September 30, 2025, net cash used in operating activities was $6.3 million, which consisted of a net loss of $6.4 million and a net change of $0.3 million comprised primarily of stock-based compensation expense and depreciation expense, offset by a net change of $0.2 million in our net operating assets and liabilities.

During the nine months ended September 30, 2024, net cash used in operating activities was $14.6 million, which consisted of a net loss of $13.3 million and a net change of $1.3 million in our net operating assets and liabilities.

Net Cash Used in Investing Activities

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.

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

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

Net Cash Provided by Financing Activities

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.

During the nine months ended September 30, 2025, net cash provided by financing activities was $12.5 million and was primarily due to the May 2025 Public Offering of $3.4 million and the Class H Warrant Inducement in September 2025 of $8.7 million.

During the nine months ended September 30, 2024, net cash provided by financing activities was $9.2 million from net proceeds of $5.4 million received in connection with the February 2024 Public Offering, $0.2 million received from exercises of the Class D Common Stock Warrants, and $3.5 million received in connection with the Warrant Inducement.

Contractual Obligations and Other Commitments

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Off-Balance Sheet Arrangements

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.

As of September 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