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Item 2. Management’s Discussion and Analysis

2026-08-04 compared with 2026-05-05 · 59 added, 41 removed, 127 unchanged (44% of the section changed)

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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.

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.

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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.

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.

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.

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Financial Overview

Since our inception, our operations have primarily focused on raising capital, establishing and protecting our intellectual property portfolio, organizing and staffing our company, business planning, and conducting preclinical and clinical development of and manufacturing development for our product candidates.

and clinical development of and manufacturing development for our product candidates.

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 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.

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.

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.

As of June 30, 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 June 30, 2026.

Components of Our Results of Operations

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

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

Product 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.

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Completion dates and completion costs can vary significantly for each product candidate and are difficult to predict.

We anticipate that we will make determinations as to which programs to pursue and how much funding to direct to each program on an ongoing basis in response to our ability to enter strategic alliances with respect to each program or product candidate, the scientific and clinical success of each product candidate, and ongoing assessments as to each product candidate’s commercial potential.

We anticipate that we will make determinations as to which programs to pursue and how much funding to direct to each program on an ongoing basis

in response to our ability to enter strategic alliances with respect to each program or product candidate, the scientific and clinical success of each product candidate, and ongoing assessments as to each product candidate’s commercial potential.

We will need to raise additional capital and may seek strategic alliances in the future to advance our various programs.

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Interest Income

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

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.

Results of Operations

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

Comparison of the three months ended June 30, 2026 and 2025

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

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Total other income and (expense)

Net loss and comprehensive loss

Research and Development Expenses

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.

Research and development expenses were $12.6 million for both the three months ended June 30, 2026 and June 30, 2025.

The research and development expenses for the three months ended June 30, 2026 included a $0.5 million increase in clinical trial costs which was offset by a decrease of $0.5 million in outsourced preclinical research and development expenses.

General and Administrative Expenses

General and administrative expenses were $4.3 million for the three months ended June 30, 2026 compared to $3.7 million for the three months ended June 30, 2025.

The increase of approximately $0.6 million was primarily

due to $0.3 million in increased personnel-related costs, including $0.1 million of increased share-based compensation charges.

In addition, consulting fees increased by $0.2 million.

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.

Comparison of the six months ended June 30, 2026 and 2025

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:

Interest income

Total other income and (expense)

Research and Development Expenses

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.

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 $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.

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.

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.

Other income was $2.0 million for the six months ended June 30, 2026 which was consistent with the six months ended June 30, 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.

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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.

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.

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.

As of June 30, 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 March 31, 2026.

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.

Funding Requirements

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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.

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.

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

• 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 OKI-345, OKI-355, and any other product candidates, 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;

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• 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, 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.

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.

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)

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Cash Flows from Operating Activities

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 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.

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 Flows from Investing Activities

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 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.

Cash Flows from Financing Activities

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.

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.

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.

Material Cash Requirements

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

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

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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 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.

During the three months ended June 30, 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

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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