What changed in this filing

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Item 2. Management’s Discussion and Analysis

2026-08-06 compared with 2026-05-07 · 42 added, 26 removed, 126 unchanged (35% of the section changed)

11 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, 2026 through the issuance and sale of our capital stock, from which we have raised net proceeds of $75.9 million.

We have funded our operations since our inception to June 30, 2026 through the issuance and sale of our capital stock, from which we have raised net proceeds of $75.9 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 unaudited condensed consolidated financial statements for March 31, 2026 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 June 30, 2026 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 $3.0 million for the three months ended March 31, 2026 and $2.1 million for the three months ended March 31, 2025.

As of March 31, 2026 we had an accumulated deficit of $52.4 million.

We have incurred recurring losses since our inception, including a net loss of $6.3 million for the six months ended June 30, 2026 and $4.5 million for the six months ended June 30, 2025.

As of June 30, 2026 we had an accumulated deficit of $55.8 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 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.

Accordingly, until such time as we can generate significant revenue from sales of Product Candidates

or other product candidates, if ever, we expect to finance our cash needs through a combination of public or private equity offerings, debt financings or other capital sources, including potential collaborations, licenses and other similar arrangements.

Accordingly, until such time as we can generate significant revenue from sales of Product Candidates or other product candidates, if ever, we expect to finance our cash needs through a combination of public or private equity offerings, debt financings or other capital sources, including potential collaborations, licenses and other similar arrangements.

However, we may be unable to raise additional funds or enter into such other arrangements when needed on favorable terms or at all.

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Recent Developments

Stockholder Rights Plan

On July 10, 2026, the Board of Directors of the Company adopted a stockholder rights plan and entered into a Rights Agreement (the “Rights Agreement”) with Continental Stock Transfer & Trust Co.

Pursuant to the Rights Agreement, the Company declared a dividend of one preferred share purchase right (a “Right”) for each outstanding share of the Company’s common stock, payable to stockholders of record at the close of business on July 21, 2026 (the “Record Date”).

The Rights will become exercisable only if a person or a group of affiliated or associated persons has become an “Acquiring Person,” which is defined in the Rights Agreement as a person or group of affiliated or associated persons who acquires or obtains the right to acquire beneficial ownership of 10% or more of the Company’s outstanding common stock (15% in the case of a person who reports their beneficial ownership on Schedule 13G) without the prior approval of the Board of Directors.

In that case, each holder of a Right will be entitled to purchase one one-thousandth of a share of the Company’s Series B Preferred at a price of $20, subject to adjustment.

The Rights are not exercisable until the Distribution Date, which is the earlier of (i) ten calendar days after a public announcement that a person has become an Acquiring Person and (ii) ten business days after the commencement of a tender or exchange offer that would result in a person becoming an Acquiring Person.

In addition, the Rights Agreement has customary flip-in, flip-over and exchange features, and the Board of Directors may redeem all of the Rights at a price of $0.001 per Right, at any time before a person becomes an Acquiring Person.

The Rights expire on the first anniversary of the Rights Agreement unless the Company’s stockholders ratify the Rights Agreement before that date, in which case the Rights expire on the third anniversary of the date of such approval, in each case subject to earlier redemption or exchange.

Reverse Stock Splits

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Other Income (Expense), Net

Other income (expense), net primarily consists of interest income from our cash balances in savings accounts and foreign currency transaction gains and losses.

Other income (expense), net primarily consists of interest income from our cash balances in savings accounts and foreign currency transaction gains and losses, in addition to other gains or losses resulting from transactions that do not relate to our continuing operations, if any.

Results of Operations

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Three Months Ended

Six Months Ended

Operating expenses:

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Three Months Ended

Six Months Ended

GEM-AKI program expenses

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Total research and development expenses

Research and development expenses increased by $0.5 million, from $0.9 million for the three months ended March 31, 2025 to $1.4 million for the three months ended March 31, 2026.

Research and development expenses increased by $0.6 million, from $1.3 million for the three months ended June 30, 2025 to $1.9 million for the three months ended June 30, 2026.

The increase was primarily due to increases of $0.7 million in program expenses related to GEM-AKI, $0.2 million in manufacturing expenses related to GEM-AKI, $0.1 million of other expenses related to the new facility, and $0.1 million in personnel expenses, offset by a $0.5 million decrease in program expenses related to GEM-CKD.

Research and development expenses increased by $1.1 million, from $2.2 million for the six months ended June 30, 2025 to $3.3 million for the six months ended June 30, 2026.

The increase was primarily due to increases of $0.7 million in program expenses related to GEM-AKI, $0.5 million in manufacturing expenses related to GEM-AKI, $0.3 million of other expenses primarily related to the new facility, and $0.2 million in personnel expenses, offset by a $0.6 million decrease in program expenses related to GEM-CKD.

General and Administrative Expenses

General and administrative expenses increased by $0.5 million, from $1.2 million for the three months ended March 31, 2025 to $1.7 million for the three months ended March 31, 2026.

General and administrative expenses increased by $0.6 million, from $1.1 million for the three months ended June 30, 2025 to $1.7 million for the three months ended June 30, 2026.

The increase was primarily due to increases of $0.5 million in personnel expenses, including stock-based compensation, and $0.1 million in professional fees.

General and administrative expenses increased by $1.1 million, from $2.4 million for the six months ended June 30, 2025 to $3.5 million for the six months ended June 30, 2026.

The increase was primarily due to increases of $0.8 million in personnel expenses, including stock-based compensation, and $0.3 million in professional fees and costs related to the new facility lease.

Other Income (Expense), Net

Other income (expense), net, was income of less than $0.1 million for both the three months ended March 31, 2026 and 2025 and related primarily to interest income from our cash balances in savings accounts and foreign currency transaction gains and losses.

Other income (expense), net, increased by $0.3 million, from $17,000 for the three months ended June 30, 2025 to $0.3 million for the three months ended June 30, 2026.

The increase was primarily due to a refund received from the state of Delaware for overpaid franchise fees totaling $0.3 million.

Other income (expense), net, increased by $0.4 million, from $0.1 million for the six months ended June 30, 2025 to $0.4 million for the six months ended June 30, 2026.

The increase was primarily due to a refund received from the Delaware Secretary of State for overpaid franchise fees totaling $0.3 million, and an increase of $0.1 million in interest income from our cash balances in savings accounts.

Liquidity and Capital Resources

Since our inception to March 31, 2026, 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 $75.9 million.

As of March 31, 2026, we had available cash and cash equivalents of $14.1 million and an accumulated deficit of $52.4 million.

Since our inception to June 30, 2026, 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 $75.9 million.

As of June 30, 2026, we had available cash and cash equivalents of $11.5 million and an accumulated deficit of $55.8 million.

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

11 unchanged sentences

Going Concern

We have incurred recurring losses since our inception, including a net loss of $3.0 million for the three months ended March 31, 2026.

As of March 31, 2026 we had an accumulated deficit of $52.4 million, a stockholders’ equity of $13.0 million and available cash and cash equivalents of $14.1 million.

We have incurred recurring losses since our inception, including a net loss of $6.3 million for the six months ended June 30, 2026.

As of June 30, 2026 we had an accumulated deficit of $55.8 million, a stockholders’ equity of $10.1 million and available cash and cash equivalents of $11.5 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 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 unaudited financial statements for March 31, 2026 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 unaudited financial statements for June 30, 2026 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.

3 unchanged sentences

The unaudited condensed consolidated financial statements for March 31, 2026, 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 June 30, 2026, 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

1 unchanged sentence

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 three months ended March 31, 2026, net cash used in operating activities was $3.2 million, which consisted of a net loss of $3.0 million, adjusted for non-cash items of $0.5 million, including stock-based compensation expense, non-cash lease expense and depreciation expense, and a net change of $0.7 million in our net operating assets and liabilities.

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, adjusted for non-cash items of $0.2 million, including the change in fair value of the warrant liability, stock-based compensation expense and depreciation expense, and a net change of $1.0 million in our net operating assets and liabilities.

During the six months ended June 30, 2026, net cash used in operating activities was $5.8 million, which consisted of a net loss of $6.3 million, adjusted for non-cash items of $1.0 million, including stock-based compensation expense, non-cash lease expense and depreciation expense, and a net change of $0.4 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, adjusted for non-cash items of $0.2 million, including the change in fair value of the warrant liability, stock-based compensation expense and depreciation expense, and a net change of $0.5 million in our net operating assets and liabilities.

Net Cash Used in Investing Activities

During the three months ended March 31, 2026, net cash used in investing activities consisted of the purchase of property and equipment.

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

During the six months ended June 30, 2026, net cash used in investing activities consisted of the purchase of property and equipment.

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

Net Cash Provided by Financing Activities

During the three months ended March 31, 2026, net cash provided by financing activities was $6.7 million and was due to net proceeds received from the Class I Warrant Inducement in January 2026.

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

During the six months ended June 30, 2026, net cash provided by financing activities was $6.7 million and was due to net proceeds received from the Class I Warrant Inducement in January 2026.

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

Contractual Obligations and Other Commitments

3 unchanged sentences

Off-Balance Sheet Arrangements

As of March 31, 2026, 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, 2026, we did not have any off-balance sheet arrangements.

Quantitative and Qualitative Disclosure about Market Risk

6 unchanged sentences

however, actual results could differ materially from these estimates and could have an adverse effect on our consolidated financial statements.

As of March 31, 2026, there have been no material changes to our existing critical accounting policies and estimates discussed in Part II, Item 7 of our Annual Report on Form 10-K for the year ended December 31, 2025.

As of June 30, 2026, there have been no material changes to our existing critical accounting policies and estimates discussed in Part II, Item 7 of our Annual Report on Form 10-K for the year ended December 31, 2025.

Recent Accounting Pronouncements

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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