What changed in this filing

/stocks — the workspaceLOADING

Item 2. Management’s Discussion and Analysis

2025-08-12 compared with 2025-05-06 · 52 added, 26 removed, 149 unchanged (34% of the section changed)

40 unchanged sentences

Since inception, we have incurred significant operating losses.

Our net losses were $15.9 million and $52.7 million for the three months ended March 31, 2025 and the year ended December 31, 2024, respectively.

As of March 31, 2025, we had an accumulated deficit of $170.6 million and cash and cash equivalents of $96.7 million.

Our net losses were $31.3 million and $52.7 million for the six months ended June 30, 2025 and the year ended December 31, 2024, respectively.

As of June 30, 2025, we had an accumulated deficit of $186.0 million and cash and cash equivalents of $83.4 million.

We have funded our operations primarily through private placements of our common stock and preferred stock and issuance of convertible debt.

As of March 31, 2025, we believe our cash resources are sufficient to fund our planned operations for at least the next 12 months from the date of issuance of these financial statements.

As of June 30, 2025, we believe our cash resources are sufficient to fund our planned operations for at least the next 12 months from the date of issuance of these financial statements.

Components of Our Results of Operations

32 unchanged sentences

Results of Operations

Comparison of the Three Months Ended March 31, 2025 and 2024

Comparison of the Three Months Ended June 30, 2025 and 2024

The following table summarizes our results of operations for the periods indicated:

Three Months Ended

(in thousands, except share

and per share amounts)

(in thousands)

Operating expenses:

5 unchanged sentences

Interest income

Interest and other expense

Total other income and (expense)

Net loss and comprehensive loss

Research and Development Expenses

Research and development expenses were $13.0 million for the three months ended March 31, 2025 compared to $8.6 million for the three months ended March 31, 2024.

The increase of $4.4 million was primarily due to a $1.9 million increase in personnel-related costs, including $1.2 million of increased share-based compensation charges.

Research and development expenses were $12.6 million for the three months ended June 30, 2025 compared to $10.8 million for the three months ended June 30, 2024.

The increase of approximately $1.9 million was primarily due to a $1.4 million increase in clinical trial and outsourced manufacturing expenses, and a $0.3 million increase in outsourced research expenses which is a result of an increase in clinical trials.

General and Administrative Expenses

General and administrative expenses were $3.7 million for the three months ended June 30, 2025 compared to $3.6 million for the three months ended June 30, 2024.

The increase of approximately $0.1 million was primarily due to $1.3 million in increased personnel-related costs, including $1.0 million of increased share-based compensation charges.

In addition, director compensation, consulting, filing fees and franchise taxes and other professional service fees, including audit fees and insurance, increased by $0.3 million.

These increases were partially offset by a $1.6 million decrease in legal expenses in 2025 as compared to the same period in 2024 due to non-recurring costs related to the Merger completed in 2024.

Other Income (Expense)

Other income (expense), net was $0.9 million for the three months ended June 30, 2025 compared to $0.2 million for the three months ended June 30, 2024.

The change was primarily due to an increase in interest income due to an increase in cash and cash equivalents available to invest during the quarter ended June 30, 2025 as compared to the quarter ended June 30, 2024.

Comparison of the Six Months Ended June 30, 2025 and 2024

The following table summarizes our results of operations for the periods indicated:

Six Months Ended

(in thousands)

Operating expenses:

Research and development

General and administrative

Total operating expenses

Loss from operations

Other income and (expense):

Interest income

Interest and other expense

Total other income and (expense)

Net loss and comprehensive loss

Research and Development Expenses

Research and development expenses were $25.6 million for the six months ended June 30, 2025 compared to $19.3 million for the six months ended June 30, 2024.

The increase of approximately $6.3 million was primarily due to a $1.9 million increase in personnel-related costs, including $1.0 million of increased share-based compensation charges.

The increase was also the result of a $3.1 million increase in clinical trial and outsourced manufacturing expenses, and a $1.1 million increase in outsourced research expenses.

1 unchanged sentence

General and Administrative Expenses

General and administrative expenses were $4.0 million for the three months ended March 31, 2025 and $1.3 million for the three months ended March 31, 2024.

The increase of $2.7 million was primarily due to $1.6 million in increased personnel-related costs, including $1.2 million of increased share-based compensation charges.

In addition, legal expenses and director compensation, consulting, and other professional service fees, including audit fees and insurance, increased by $0.9 million.

General and administrative expenses were $7.7 million for the six months ended June 30, 2025 compared to $4.9 million for the six months ended June 30, 2024.

The increase of approximately $2.8 million was primarily due to $2.9 million in increased personnel-related costs, including $2.2 million of increased share-based compensation charges.

In addition, director compensation, consulting, filing fees and franchise taxes and other professional service fees, including audit fees and insurance, increased by $1.1 million.

These increases were partially offset by a $1.3 million decrease in legal expenses in 2025 as compared to the same period in 2024 due to non-recurring costs related to the Merger completed in 2024.

We expect general and administrative expenses in 2025 to be higher than 2024 as we operate as a public company for the full year in 2025.

Other income was $1.1 million for the three months ended March 31, 2025 compared to $0.3 million of interest income for the three months ended March 31, 2024.

The change was primarily due to an increase in interest

income due to an increase in cash and cash equivalents available to invest during the quarter ended March 31, 2025 as compared to the quarter ended March 31, 2024.

Other Income (Expense)

Other income (expense) was $2.0 million for the six months ended June 30, 2025 compared to $0.5 million for the six months ended June 30, 2024.

The change was primarily due to an increase in interest income due to an increase in cash and cash equivalents available to invest during the six months ended June 30, 2025 as compared to the six months ended June 30, 2024.

We expect other income in 2025 to be higher than 2024 with higher average available cash available to invest during 2025.

5 unchanged sentences

We have funded our operations primarily through private placements of equity and convertible debt.

Based on our current operating plan, we believe that our existing cash and cash equivalents will be sufficient to fund our planned operations for at least the next 12 months from the date of issuance of our unaudited condensed consolidated financial statements for the quarter ended March 31, 2025.

Funding Requirements

9 unchanged sentences

We may be unable to raise additional capital from these sources on favorable terms, or at all.

Our ability to secure capital is dependent upon a number of factors, including our success in developing our product candidates.

Our ability to secure capital is dependent upon a number of factors, including our success in developing our product candidates and our ability to access the capital markets.

The failure to obtain sufficient capital on acceptable terms when needed could have a material adverse effect on our business, results of operations, or financial condition, including requiring us to delay, reduce, or curtail our research, product development, or future commercialization efforts.

We may also be required to license rights to product candidates at an earlier stage of development or on less favorable terms than we would

otherwise choose.

We may also be required to license rights to product candidates at an earlier stage of development or on less favorable terms than we would otherwise choose.

We cannot provide assurance that we will ever generate positive cash flow from operating activities.

14 unchanged sentences

The following table summarizes our cash flows for the periods indicated, in thousands:

Three Months Ended March 31,

Six Months Ended June 30,

(in thousands)

5 unchanged sentences

Cash Flows from Operating Activities

Cash used in operating activities during the three months ended March 31, 2025 was $14.0 million.

Cash used in operating activities during the six months ended June 30, 2025 was $27.3 million.

This consisted primarily of a net loss of $31.3 million, a net decrease in operating assets and liabilities of $2.0 million, and non-cash share-based compensation of $5.7 million.

Cash used in operating activities during the three months ended March 31, 2024 was $10.6 million.

Cash used in operating activities during the six months ended June 30, 2024 was $17.1 million.

This consisted primarily of a net loss of $23.7 million, and a net decrease in our operating assets and liabilities of $4.4 million, partially offset for share-based compensation and depreciation and amortization.

Cash Flows from Investing Activities

Cash used in investing activities was $18 thousand and $9 thousand for the three months ended March 31, 2025 and 2024, respectively, and related to purchase of property and equipment.

Cash used in investing activities was $31 thousand and $19 thousand for the six months ended June 30, 2025 and 2024, respectively, and related to purchase of property and equipment.

Cash Flows from Financing Activities

Cash used in financing activities during the three months ended March 31, 2025 was $77 thousand and related to payment of issuance costs from the Concurrent Financing and reverse recapitalization transaction costs in connection with the Merger.

Cash provided by financing activities during the three months ended March 31, 2024 was $10 thousand and related to proceeds from the sale of shares of Common Stock in connection with equity plans.

Cash used in financing activities during the six months ended June 30, 2025 was $77 thousand and related to payment of issuance costs from the Concurrent Financing and reverse recapitalization transaction costs in connection with the Merger.

Cash provided by financing activities during the six months ended June 30, 2024 was $5.9 million and primarily related to proceeds from the issuance of convertible notes payable.

Material Cash Requirements

The discussion below summarizes our significant contractual obligations and commitments as of March 31, 2025.

The discussion below summarizes our significant contractual obligations and commitments as of June 30, 2025.

See Note 5 of Notes to our Condensed Consolidated Financial Statements included in this Quarterly Report on Form 10-Q for information regarding our leases, including the future operating lease minimum payments.

5 unchanged sentences

Our critical accounting policies are described in our audited financial statements and the related notes for the years ended December 31, 2024 and 2023 included in our Annual Report on Form 10-K for the year ended December 31, 2024, and the notes to the condensed consolidated financial statements appearing elsewhere in this Quarterly Report on Form 10-Q.

During the three months ended March 31, 2025, there were no material changes to our critical accounting policies from those discussed in our Annual Report on Form 10-K for the year ended December 31, 2024.

During the three months ended June 30, 2025, there were no material changes to our critical accounting policies from those discussed in our Annual Report on Form 10-K for the year ended December 31, 2024.

Recent Accounting Pronouncements

3 unchanged sentences

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