What changed in this filing

/stocks — the workspaceLOADING

Item 2. Management’s Discussion and Analysis

2026-05-05 compared with 2025-11-06 · 56 added, 91 removed, 112 unchanged (57% of the section changed)

Management’s Discussion and Analysis of Financial Condition and Results of Operations

You should read the following discussion and analysis of our financial condition and results of operations together with our condensed consolidated financial statements and related notes included elsewhere in this Quarterly Report on Form 10-Q and our audited consolidated financial statements and notes thereto and the related Management’s Discussion and Analysis of Financial Condition and Results of Operations included in Legacy OnKure’s 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 subsequent filings.

You should read the following discussion and analysis of our financial condition and results of operations together with our condensed consolidated financial statements and related notes included elsewhere in this Quarterly Report on Form 10-Q and our audited consolidated financial statements and notes thereto and the related Management’s Discussion and Analysis of Financial Condition and Results of Operations included in our audited financial statements and the related notes for the years ended December 31, 2025 and 2024 included in our Annual Report on Form 10-K for the year ended December 31, 2025, and subsequent filings.

Unless otherwise indicated, all references in this Quarterly Report on Form 10-Q to “OnKure,” the “Company,” “we,” “our,” “us,” or similar terms refer to OnKure Therapeutics, Inc.

and its subsidiaries after completion of the Merger.

In addition, references to “Reneo” refer to the Company prior to the completion of the Merger.

Forward-Looking Statements

In addition to historical financial information, this discussion and analysis contains forward-looking statements based upon our current beliefs, estimates, plans, and expectations that involve risks, uncertainties, and assumptions.

Our actual results may differ materially from those contained in these forward-looking statements as a result of various factors, including those set forth in the section titled “Risk Factors” under Part II, Item 1A below.

In some cases, you can identify forward-looking statements by terminology such as “aim,” “anticipate,” “assume,” “believe,” “contemplate,” “continue,” “could,” “design,” “due,” “estimate,” “expect,” “goal,” “intend,” “may,” “objective,” “plan,” “predict,” “project,” “positioned,” “potential,” “seek,” “should,” “target,” “will,” “would” or the negative of these terms or other similar expressions.

In addition, statements that “we believe” and similar statements reflect our beliefs and opinions on the relevant subject.

These statements are based upon information available to us as of the date of this Quarterly Report on Form 10-Q, and while we believe such information forms a reasonable basis for such statements, such information may be limited or incomplete, and our statements should not be read to indicate that we have conducted an exhaustive inquiry into, or review of, all potentially available relevant information.

These statements are inherently uncertain, and investors are cautioned not to unduly rely upon these statements.

We are a clinical-stage biopharmaceutical company focused on the discovery and development of precision medicines that target biologically validated drivers of cancers underserved by available therapies.

Using a structure- and computational chemistry-driven drug design platform, we are committed to improving clinical outcomes for patients by building a robust pipeline of small molecule drugs designed to selectively target specific mutations thought to be key drivers of cancer.

We are a clinical-stage biopharmaceutical company focused on the discovery and development of precision medicines that target biologically validated drivers of vascular anomalies and cancers that are underserved by available therapies.

Using a structure- and computational chemistry-driven drug design platform, we are committed to improving clinical outcomes for patients by building a pipeline of small molecule drugs designed to selectively target specific mutations thought to be key drivers of cancer and vascular anomalies.

By improving selectivity for the oncogenic and mutated form of these cancer-driver proteins, we aim to discover and develop drugs with improved safety and efficacy by sparing toxicity that arises from non-selective inhibition of the non-mutated (or wild-type) version of the protein.

1 unchanged sentence

We designed our current product candidates utilizing disciplined medicinal chemistry, x-ray crystallography, and computational chemistry to inhibit specified mutated versions of PI3K α , a key mediator in cancer growth signaling.

Our lead product candidate, OKI-219, is a highly selective inhibitor of PI3K α H1047R that has a much smaller impact on PI3K α WT .

We plan to initially focus on the development of OKI-219 in patients with advanced breast cancer of genetic subtypes that are (a) both HR+ and HER2-;

and (b) HER2+.

We believe we can potentially expand the application of OKI-219 by conducting appropriate clinical trials in earlier lines of treatment within breast cancer, other subtypes of breast cancer, and potentially in other solid tumors.

OKI-219 is currently in a first-in-human Phase 1a/1b clinical trial.

On the Closing Date, Reneo consummated the previously announced Merger pursuant to the terms of the Merger Agreement, by and among Reneo, Merger Sub I, Merger Sub II, and Legacy OnKure.

Pursuant to the Merger Agreement, on the Closing Date, (i) Reneo effected a reverse stock split of Reneo’s issued common stock at a ratio of 1:10, (ii) Reneo changed its name to “OnKure Therapeutics, Inc.”, (iii) Reneo reclassified all of its common stock as “Class A Common Stock” or “Class B Common Stock”, and (iv) Radiate Merger Sub I merged with and into Legacy OnKure, with Legacy OnKure as the surviving company in the Merger and, after giving effect to such Merger, Legacy OnKure becoming a wholly owned subsidiary of OnKure

Therapeutics, Inc.

Concurrently with the closing of the Merger, Reneo completed a private placement with certain investors (the “Concurrent Investors”) to purchase 2,839,005 shares of Common Stock at a price per share of approximately $22.895 per share for an aggregate purchase price of approximately $65.0 million, including the conversion of outstanding convertible notes and accrued but unpaid interest thereon held by certain Legacy OnKure investors (the “Concurrent Financing”).

In connection with the Concurrent Financing, Reneo entered into a registration rights agreement with certain investors, pursuant to which Reneo agreed to use commercially reasonably efforts to prepare and file a registration statement with the SEC within 45 calendar days after the Closing Date, registering the resale of the shares of Common Stock issued pursuant to the Concurrent Financing, which was filed in October 2024.

Immediately after the effective time of the Merger, following the consummation of the Concurrent Financing, shares received by Legacy OnKure stockholders represented approximately 53.6%, pre-Merger Reneo shares outstanding represented approximately 25.1%, and the shares purchased in the Concurrent Financing represented approximately 21.3% of our outstanding Common Stock.

As of the open of trading on October 7, 2024, our Common Stock began trading on Nasdaq under the symbol “OKUR.”

Next-Generation PI3K α Pan-Mutant Programs

Our portfolio includes two next-generation PI3Kα pan-mutant programs, OKI-345 in breast cancer and OKI-355 in vascular anomalies.

These candidates are designed to selectively inhibit mutant PI3Kα while sparing wildtype PI3Kα, potentially enabling a wider therapeutic index and avoidance of class-limiting toxicities.

High and sustained target coverage across all hotspot PI3Kα mutations can support the potential for deep and durable responses in breast cancer, both as monotherapy and in combination regimens.

The PI3Kα pan-mutant candidates are designed to have minimal drug-drug interaction potential, supporting broad combinability with current standards of care.

We plan to submit an Investigational New Drug (“IND”) application to the U.S.

Food and Drug Administration for each of OKI-345 and OKI-355 in the first half of 2027.

PIKture-01 Trial and OKI-219 Update

The PIKture-01 trial is a global, multi-center, dose-escalation, first-in-human Phase 1a/1b study evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of OKI-219 as monotherapy and in combination with other anti-cancer drugs for the treatment of HR+ and HER2+ advanced breast cancer.

As of March 26, 2026, the PIKture-01 trial has completed enrollment in single-agent OKI-219 dose escalation (n=38) and OKI-219 + fulvestrant dose escalation (n=33).

Phase 2 dose evaluation in the OKI-219 + tucatinib and trastuzumab triplet and the OKI-219 + ribociclib and fulvestrant triplets will be completed in 2026.

Given the progress of our PI3Kα pan-mutant inhibitors, we do not plan to pursue further clinical development of OKI-219 independently.

On October 4, 2024, we completed the Merger.

Refer to Note 1 “Organization and Business” to the condensed consolidated financial statements included in Part I, Item 1 of this Quarterly Report on Form 10-Q for information regarding the Merger.

Macroeconomic and Geopolitical Considerations

9 unchanged sentences

We do not have any product candidates approved for sale, have not generated any revenue from product sales, and do not expect to generate revenues from the commercial sale of any products for the foreseeable future, if ever.

Since inception, we have incurred significant operating losses.

Our net losses were $46.0 million and $52.7 million for the nine months ended September 30, 2025 and the year ended December 31, 2024, respectively.

As of September 30, 2025, we had an accumulated deficit of $200.7 million and cash and cash equivalents of $70.3 million.

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

As of September 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.

Since our inception, we have incurred significant operating losses.

Our net losses were $15.2 million and $59.5 million for the three months ended March 31, 2026 and the year ended December 31, 2025, respectively.

As of March 31, 2026, we had an accumulated deficit of $229.4 million and cash and cash equivalents of $192.1 million.

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

As of March 31, 2026, 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 our unaudited condensed consolidated financial statements for the quarter ended March 31, 2026.

Components of Our Results of Operations

12 unchanged sentences

Employees and infrastructure are not directly tied to any one program and are typically deployed across multiple programs;

therefore, we do not track our research and development expenses on a program-specific basis.

therefore, we do not track these research and development expenses on a program-specific basis.

Conducting preclinical studies and clinical trials necessary to obtain regulatory approval is costly and time-consuming.

As we initiate new clinical trials, our research and development expenses may increase.

Product candidates in later stages of development generally have higher development costs than those in earlier stages.

candidates in later stages of development generally have higher development costs than those in earlier stages.

As a result, we expect that our research and development expenses will increase substantially over the next several years as we advance product candidates through preclinical studies into and through clinical trials, continue to discover and develop additional product candidates, undertake activities to expand, maintain, protect, and enforce our intellectual property portfolio, and hire additional research and development personnel.

11 unchanged sentences

Interest income primarily consists of interest income generated from our cash equivalents in interest-bearing money market accounts.

Interest Expense

Interest expense consists primarily of interest expense generated from our convertible notes payable, which were issued in 2024 and converted at the time of the Merger in 2024.

Results of Operations

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

Comparison of the three months ended March 31, 2026 and 2025

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

Three Months Ended

September 30,

(in thousands)

6 unchanged sentences

Interest income

Interest and other expense

Total other income and (expense)

1 unchanged sentence

Research and Development Expenses

Research and development expenses were $11.9 million for the three months ended September 30, 2025 compared to $10.1 million for the three months ended September 30, 2024.

The increase of approximately $1.8 million was primarily due to a $1.9 million increase in personnel-related costs, including $1.3 million of increased share-based compensation charges.

General and Administrative Expenses

General and administrative expenses were $3.6 million for the three months ended September 30, 2025 compared to $1.4 million for the three months ended September 30, 2024.

The increase of approximately $2.2 million was primarily due to $1.5 million in increased personnel-related costs, including $1.3 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 $0.5 million.

Other Income (Expense)

Other income (expense), net was $0.8 million for the three months ended September 30, 2025 compared to $0.1 million for the three months ended September 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 September 30, 2025 as compared to the quarter ended September 30, 2024.

Comparison of the Nine Months Ended September 30, 2025 and 2024

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

Nine Months Ended

September 30,

(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 $37.5 million for the nine months ended September 30, 2025 compared to $29.4 million for the nine months ended September 30, 2024.

The increase of approximately $8.1 million was primarily due to a $3.8 million increase in personnel-related costs, including $2.4 million of increased share-based compensation charges.

The increase was also the result of a $2.9 million increase in clinical trial and outsourced manufacturing expenses, and a $1.1 million increase in outsourced research expenses.

We expect research and development expenses in 2025 to be higher than 2024 due to continued efforts to advance our clinical and preclinical programs.

Research and development expenses were $11.7 million for the three months ended March 31, 2026 compared to $13.0 million for the three months ended March 31, 2025.

The decrease of approximately $1.3 million was primarily due to $1.8 million of decreased outsourced research and development, partially offset by an increase of $0.7 million clinical trial costs.

We expect research and development expenses in 2026 to be higher than 2025 due to continued efforts to advance our programs.

General and Administrative Expenses

General and administrative expenses were $11.3 million for the nine months ended September 30, 2025 compared to $6.3 million for the nine months ended September 30, 2024.

The increase of approximately $5.0 million was primarily due to $4.4 million in increased personnel-related costs, including $3.5 million of increased share-based compensation charges.

In addition, director compensation, consulting, filing fees and franchise taxes and other professional service fees, including audit, filing fees and insurance, increased by $1.6 million.

These increases were partially offset by a $1.2 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 (Expense)

Other income (expense) was $2.8 million for the nine months ended September 30, 2025 compared to $0.5 million for the nine months ended September 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 nine months ended September 30, 2025 as compared to the nine months ended September 30, 2024.

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

General and administrative expenses were $3.9 million for the three months ended March 31, 2026 compared to $4.0 million for the three months ended March 31, 2025.

The decrease of approximately $0.1 million was primarily due to a $0.3 million decrease in legal and filing fee costs.

This decrease was partially offset by a $0.2 million increase personnel-related costs, including share-based compensation.

We expect general and administrative expenses in 2026 to be higher than 2025.

Other income was $0.5 million for the three months ended March 31, 2026 compared to $1.1 million for the three months ended March 31, 2025.

The change was primarily due to a decrease in interest income due to a decrease in cash and cash equivalents available to invest during the quarter ended March 31, 2026 as compared to the quarter ended March 31, 2025.

We expect other income in 2026 to be higher than 2025 with higher average available cash to invest during 2026 given the 2026 Private Placement that closed March 31, 2026.

Liquidity and Capital Resources

Since inception, we have not generated any revenue from product sales and have incurred significant operating losses and negative cash flows from our operations.

We expect to continue to incur significant expenses and operating losses for the foreseeable future as we advance the clinical development of our product candidates.

We expect that our research and development and general and administrative costs will continue to increase significantly, including in connection with conducting clinical trials and manufacturing our product candidates to support commercialization and providing general and administrative support for our operations, including the costs associated with operating as a public company following the Closing.

We expect to continue to incur significant expenses and operating losses for the foreseeable future as we advance the development of our product candidates.

We expect that our research and development and general and administrative costs will continue to increase significantly, including in connection with initiating and conducting clinical trials and manufacturing our product candidates to support such clinical trials and commercialization and providing general and administrative support for our operations.

As a result, we will need additional capital to fund our operations, which we may seek to obtain from equity or debt financings, collaborations, licensing arrangements or other sources.

In March 2026, we completed the 2026 Private Placement for aggregate gross proceeds of approximately $150.0 million, before deducting placement agent fees and offering expenses.

Pursuant to the 2026 PIPE Purchase Agreement, we agreed to use the proceeds from the 2026 Private Placement for research and development expenses for our vascular anomalies and breast cancer programs, excluding OKI-219, and for working capital and other general corporate purposes.

In November 2025, we filed the Registration Statement, which registered an aggregate of up to $200 million of securities that may be issued and sold from time to time, including initially up to an aggregate offering price of $16.0 million of Common Stock (which is included in the $200 million aggregate offering price set forth in the base prospectus) that may be issued and sold pursuant to the ATM Sales Agreement.

As of March 31, 2026, no shares have been sold under the ATM Sales Agreement.

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 September 30, 2025.

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, 2026.

Funding Requirements

14 unchanged sentences

Our future funding requirements will depend on many factors, including:

• the scope, timing, progress, results, and costs of researching and developing OKI-219, and conducting preclinical studies and clinical trials;

• the scope, timing, progress, results, and costs of researching and developing OKI-219, OKI-345 and OKI-355 and conducting preclinical studies and clinical trials;

• the scope, timing, progress, results and costs of researching and developing other product candidates that we may pursue;

8 unchanged sentences

• the costs associated with operating as a public company.

A change in the outcome of any of these or other factors with respect to the development of OKI-219 or any of our future product candidates could significantly change the costs and timing associated with the development of that product candidate.

A change in the outcome of any of these or other factors with respect to the development of OKI-219, OKI-345 and OKI-355 or any of our future product candidates could significantly change the costs and timing associated with the development of that product candidate.

Furthermore, our operating plans may change in the future, and we may need additional capital to meet the capital requirements associated with such operating plans.

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

Nine Months Ended

September 30,

Three Months Ended March 31,

(in thousands)

3 unchanged sentences

Financing activities

Net decrease in cash and cash equivalents

Net increase (decrease) in cash and cash equivalents

Cash Flows from Operating Activities

Cash used in operating activities during the nine months ended September 30, 2025 was $40.3 million.

This consisted primarily of a net loss of $46.0 million, a net decrease in operating assets and liabilities of $3.5 million, and non-cash share-based compensation of $8.6 million.

Cash used in operating activities during the nine months ended September 30, 2024 was $27.8 million.

This consisted primarily of a net loss of $35.2 million, and a net decrease in our operating assets and liabilities of $4.9 million, and by an increase in non-cash charges for share-based compensation and depreciation and amortization of $2.6 million.

Cash used in operating activities during the three months ended March 31, 2026 was $12.9 million.

This consisted primarily of a net loss of $15.2 million, a net decrease in operating assets and liabilities of $0.8 million, offset by non-cash share-based compensation of $2.8 million.

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

This consisted primarily of a net loss of $15.9 million, a net decrease in operating assets and liabilities of $1.0 million, offset by non-cash share-based compensation of $2.7 million.

Cash Flows from Investing Activities

Cash used in investing activities was $37 thousand and $37 thousand for the nine months ended September 30, 2025 and 2024, respectively, and related to purchase of property and equipment.

Cash used in investing activities was $5 thousand and $18 thousand for three months ended March 31, 2026 and 2025, respectively, and related to purchase of property and equipment.

Cash Flows from Financing Activities

Cash used in financing activities during the nine months ended September 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 nine months ended September 30, 2024 was $5.9 million and primarily related to proceeds from the issuance of convertible notes payable.

Cash provided by financing activities during the three months ended March 31, 2026 was $146.0 million and related to proceeds from the sale of Common Stock and pre-funded warrants in connection with the 2026 Private Placement.

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.

Material Cash Requirements

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

The discussion below summarizes our significant contractual obligations and commitments as of March 31, 2026.

See Note 4 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, 2025 and 2024 included in our Annual Report on Form 10-K for the year ended December 31, 2025, and the notes to the condensed consolidated financial statements appearing elsewhere in this Quarterly Report on Form 10-Q.

During the three months ended September 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.

During the three months ended March 31, 2026, 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, 2025.

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