OnKure Therapeutics, Inc.

Previous wording

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. We work under the belief that inhibiting target proteins with specific mutations instead of wild-type variants should enable precise patient selection that will, in turn, improve the probability of clinical success. We designed our current product candidates utilizing disciplined medicinal chemistry, x-ray crystallography, and computational chemistry to inhibit specified mutated versions of PI3Kα, a key mediator in cancer growth signaling.

Current wording

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 mutated form of these disease-driving 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. We work under the belief that inhibiting target proteins with specific mutations instead of wild-type variants should enable precise patient selection that will, in turn, improve the probability of clinical success. We designed our current product candidates utilizing disciplined medicinal chemistry, x-ray crystallography, and computational chemistry to inhibit specified mutated versions of PI3Kα, a key mediator in cancer growth signaling.

Previous wording

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.

Current wording

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

Previous wording

Further, it is possible that U.S. and non-U.S. government policy changes and related uncertainty about policy changes could increase market volatility and our operating expenses. The extent, severity, and duration of the impacts of these events and conditions on our business cannot be predicted and may not be fully reflected in our results of operations until future periods. If economic uncertainty continues or increases, or if the global economy worsens, our business, financial condition, and results of operations may be harmed. For further discussion of the potential impacts of macroeconomic events and conditions on our business, financial condition, and operating results, see the section titled “Risk Factors” included in this Quarterly Report.

Current wording

Our business and operations may be negatively affected by macroeconomic, geopolitical, and regulatory developments, including inflation, instability in the banking and financial services sector, tightening of the credit markets, international conflicts, cybersecurity, tariffs, sanctions, export controls, government policy positions, and changes in regulatory agencies with oversight of our operations. These developments could affect our supply chain, manufacturing processes, regulatory compliance costs, regulatory approval timelines, and cross-border operations. Further, it is possible that U.S. and non-U.S. government policy changes and related uncertainty about policy changes could increase market volatility and our operating expenses. The extent, severity, and duration of the impacts of these events and conditions on our business cannot be predicted and may not be fully reflected in our results of operations until future periods. If economic uncertainty continues or increases, or if the global economy worsens, our business, financial condition, and results of operations may be harmed. For further discussion of the potential impacts of macroeconomic events and conditions on our business, financial condition, and operating results, see the section titled “Risk Factors” included in this Quarterly Report.

Previous wording

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.

Current wording

Since our inception, we have incurred significant operating losses. Our net losses were $30.5 million and $59.5 million for the six months ended June 30, 2026 and the year ended December 31, 2025, respectively. As of June 30, 2026, we had an accumulated deficit of $244.7 million and cash, cash equivalents and marketable securities of $176.4 million.

Previous wording

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

Current wording

Interest income primarily consists of interest income generated from our cash equivalents and marketable securities in interest-bearing money market accounts and short-term government securities.

Previous wording

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.

Current wording

Other income was $1.6 million for the three months ended June 30, 2026 compared to $0.9 million for the three months ended June 30, 2025. The change was primarily due to an increase in interest income due to an increase in cash, cash equivalents and marketable securities available to invest during the quarter ended June 30, 2026 as compared to the quarter ended June 30, 2025.

Previous wording

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.

Current wording

Research and development expenses were $24.3 million for the six months ended June 30, 2026 compared to $25.6 million for the six months ended June 30, 2025. The decrease of approximately $1.3 million was primarily due to $1.5 million of decreased outsourced preclinical research and development expenses and $0.4 million of personnel-related costs, partially offset by an increase of $0.6 million clinical trial and outsourced manufacturing costs.

Previous wording

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.

Current wording

General and administrative expenses were $8.2 million for the six months ended June 30, 2026 compared to $7.7 million for the six months ended June 30, 2025. The increase of approximately $0.5 million was primarily due to a $0.5 million increase in personnel-related costs, including $0.2 million of increased share-based compensation charges, and $0.1 million increase in consulting costs. These increases were partially offset by a $0.1 million decrease in legal and filing fee costs.

Previous wording

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.

Current wording

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 our former lead product candidate, OKI-219, and for working capital and other general corporate purposes.

Previous wording

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, 2026.

Current wording

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, cash equivalents and marketable securities 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 June 30, 2026.

Previous wording

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;

Current wording

the scope, timing, progress, results, and costs of researching and developing OKI-345, OKI-355, and any other product candidates, and conducting preclinical studies and clinical trials;

Previous wording

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.

Current wording

A change in the outcome of any of these or other factors with respect to the development of OKI-345 and OKI-355 or any other 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.

Previous wording

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.

Current wording

Cash used in operating activities during the six months ended June 30, 2026 was $23.3 million. This consisted primarily of a net loss of $30.5 million, a net increase in operating assets and liabilities of $1.0 million, offset by non-cash share-based compensation of $5.8 million.

Previous wording

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.

Current wording

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.

Previous wording

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.

Current wording

Cash used in investing activities was $9.9 million for six months ended June 30, 2026, and primarily related to purchases of marketable securities. Cash used in investing activities was $31 thousand for six months ended June 30, 2025, related to purchase of property and equipment.

Previous wording

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.

Current wording

Cash provided by financing activities during the six months ended June 30, 2026 was $140.6 million and primarily related to the net proceeds from the sale of Common Stock and pre-funded warrants in connection with the 2026 Private Placement and proceeds from the sale of stock under the employee stock purchase plan.

Previous wording

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.

Current wording

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.