8 unchanged sentences
• We have never generated revenue from product sales and may never achieve or maintain profitability.
−Removed: • We are substantially dependent on OKI-219.
−Removed: If we are unable to advance OKI-219 through clinical development, obtain regulatory approval and ultimately commercialize such product candidate, or experience significant delays in doing so, our business will be materially harmed.
−Removed: • We have limited resources and are currently focusing our efforts on OKI-219 for development in particular indications and advancing our other discovery research programs.
+Added: • We will need substantial additional funding before we can complete the development of our product candidates.
+Added: If we are unable to obtain such additional capital on favorable terms, on a timely basis, or at all, we would be forced to delay, reduce or eliminate our product development and clinical programs and may not have the capital required to otherwise operate our business.
+Added: • If we are unable to advance OKI-345 and OKI-355 through preclinical and clinical development, obtain regulatory approval and ultimately commercialize one or more of such product candidates, or experience significant delays in doing so, our business will be materially harmed.
+Added: • We have limited resources.
As a result, we may fail to capitalize on programs, product candidates or indications that may be more profitable or for which there is a greater likelihood of success.
5 unchanged sentences
• If we are unable to establish sales and marketing capabilities or enter into agreements with third parties to sell and market our product candidates on acceptable terms, we may be unable to successfully commercialize our product candidates that obtain regulatory approval.
−Removed: • If we are unable to obtain and maintain sufficient intellectual property protection for our technology and products and product candidates we may develop, or if the scope of the intellectual property protection obtained is not sufficiently broad, our competitors or other third parties could develop and commercialize products similar or identical to ours, and our ability to successfully develop and, if approved, commercialize our product candidates may be adversely affected.
+Added: • If we are unable to obtain and maintain sufficient intellectual property protection for our technology and product candidates, or if the scope of the intellectual property protection obtained is not sufficiently broad, our competitors or other third parties could develop and commercialize products similar or identical to ours, and our ability to successfully develop and, if approved, commercialize our product candidates may be adversely affected.
• We rely, and expect to continue to rely, on third parties, including independent clinical investigators and CROs, to conduct, supervise, and monitor certain aspects of our clinical trials and preclinical studies.
2 unchanged sentences
• The market price of our Class A Common Stock has been and is expected to continue to be volatile.
−Removed: • We will need substantial additional funding before we can complete the development of our product candidates.
−Removed: If we are unable to obtain such additional capital on favorable terms, on a timely basis, or at all, we would be forced to delay, reduce or eliminate our product development and clinical programs and may not have the capital required to otherwise operate our business.
• Our Amended Certificate of Incorporation, our Amended Bylaws, and provisions of Delaware law could make acquiring us more difficult and may prevent attempts by our stockholders to replace or remove our management.
1 unchanged sentence
As a result, we are subject to more stringent reporting requirements, offering limitations, and resale restrictions than some other companies.
−Removed: • A robust trading market for our Class A Common Stock may not develop, and the holders of our Class A Common Stock may not be able to resell their shares of our Class A Common Stock for a profit, if at all.
• We could be subject to securities class action litigation, which is expensive and could divert management attention.
6 unchanged sentences
As a result, it may be difficult for investors to accurately predict our likelihood of success and viability.
−Removed: In addition, we may encounter unforeseen expenses, difficulties, complications, delays and other known and unknown factors and risks frequently experienced by early-stage biopharmaceutical companies in rapidly evolving
+Added: In addition, we may encounter unforeseen expenses, difficulties, complications, delays and other known and unknown factors and risks frequently experienced by early-stage biopharmaceutical companies in rapidly evolving fields.
We also expect that, as we advance our product candidates, we will need to transition from a company with a research and development focus to a company capable of supporting commercial activities.
3 unchanged sentences
We have incurred significant net losses in each reporting period since inception, have not generated any revenue from the sale of products, and have funded our operations primarily from the sale and issuance of equity securities and convertible debt.
−Removed: 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.
−Removed: As of September 30, 2025, we had an accumulated deficit of $200.7 million.
+Added: Our net losses were $15.2 million and $59.5 million for three months ended March 31, 2026 and the year ended December 31, 2025, respectively.
+Added: As of March 31, 2026, we had an accumulated deficit of $229.4 million.
We have no products approved for sale.
11 unchanged sentences
Our ability to generate revenue and achieve profitability depends significantly on our ability to achieve several objectives, including:
−Removed: successful and timely completion of clinical development of OKI-219 and preclinical and clinical development of other pipeline programs and any other future programs;
−Removed: establishing and maintaining relationships with contract research organizations (or “CROs”) and clinical sites for the clinical development of OKI-219 and any other future programs;
+Added: successful and timely initiation and completion of preclinical and clinical development of OKI-345, OKI-355, our research programs and any other future programs;
+Added: establishing and maintaining relationships with contract research organizations (or “CROs”) and clinical sites for the clinical development of OKI-219, OKI-345, OKI-355 and any other future programs;
timely receipt of marketing approvals from applicable regulatory authorities for any product candidates for which we successfully complete clinical development;
26 unchanged sentences
Developing pharmaceutical products, including conducting preclinical studies and clinical trials, is expensive.
−Removed: We have not generated any revenues from the commercial sale of products and will not be able to generate any product revenues until, and only if, we receive approval to sell our product candidates from the FDA or other regulatory authorities.
−Removed: Our cash, cash equivalents and short-term investments are expected to fund operations into the fourth quarter of 2026.
−Removed: However, as we have not generated any revenue from commercial sales to date and do not expect to generate any revenue for several years, if ever, we will need to raise substantial additional capital in
−Removed: order to fund our general corporate activities and to fund our research and development, including our currently planned clinical trials and plans for new clinical trials and product development.
+Added: Our cash and cash equivalents are expected to fund operations into 2029.
+Added: As we have not generated any revenue from commercial sales to date and do not expect to generate any revenue for several years, if ever, we will need to raise substantial additional capital in order to fund our general corporate activities and to fund our research and development, including our currently planned clinical trials and plans for new clinical trials and product development.
We may seek to raise additional funds through various potential sources, such as equity and debt financings, or through strategic collaborations and license agreements.
We can give no assurances that we will be able to secure such additional sources of funds to support our operations or, if such funds are available, that such additional financing will be sufficient to meet our needs.
−Removed: Moreover, to the extent that we raise additional funds by issuing equity securities, our stockholders may experience additional significant dilution and new investors could gain rights, preferences and privileges senior to the holders of common stock.
−Removed: Debt financing, if available, may involve restrictive covenants.
+Added: Moreover, to the extent that we raise additional funds by issuing equity securities, our stockholders may experience additional significant dilution and new investors could
+Added: gain rights, preferences and privileges senior to the holders of common stock.
+Added: For example, pursuant to the 2026 Private Placement, we issued and sold 26,713,638 shares of our Common Stock and pre-funded warrants to purchase 9,320,957 shares of our Common Stock, which resulted, and may continue to result, in a significant increase in the number of our outstanding shares of common stock and substantially diluted the ownership interests of our existing stockholders.
+Added: Debt financing, if available, may involve restrictive covenants, and equity financing, if available, may include restrictions on our use of proceeds.
+Added: For example, pursuant to the 2026 PIPE Purchase Agreement, we are unable to use the proceeds from the 2026 Private Placement for research and development expenses for OKI-219.
+Added: This could hinder our ability to advance OKI-219 in the future.
+Added: We may experience similar or more onerous restrictions on use of proceeds in future financings.
To the extent that we raise additional funds through collaboration and licensing arrangements, it may be necessary to relinquish some rights to our technologies or product candidates, or grant licenses on terms that may not be favorable.
5 unchanged sentences
Risks Related to Our Development and Commercialization of Our Product Candidates
−Removed: We are substantially dependent on OKI-219.
−Removed: If we are unable to advance OKI-219 through clinical development, obtain regulatory approval and ultimately commercialize such product candidate, or experience significant delays in doing so, our business will be materially harmed.
−Removed: We are currently evaluating OKI-219 in a Phase 1 clinical trial.
−Removed: We will be required to demonstrate thorough, adequate, and well controlled clinical trials that OKI-219 is safe and effective, with a favorable benefit-risk profile, for use in its target indication before we can seek regulatory approvals for its commercial sale.
+Added: We are very early in our development efforts of OKI-345 or OKI-355.
+Added: If we are unable to advance OKI-345 or OKI-355 through preclinical and clinical development, obtain regulatory approval and ultimately commercialize one or more of such product candidates, or experience significant delays in doing so, our business will be materially harmed.
+Added: We are very early in our development efforts of OKI-345 or OKI-355.
+Added: We plan to submit an IND application to the FDA for each of OKI-345 and OKI-355 in the first half of 2027.
+Added: If we do not successfully complete preclinical testing of OKI-345 or OKI-355 and initiate and complete our planned clinical trials of such product candidates in a timely manner, or fail to achieve favorable results from the trials, we may experience significant delays or other issues in advancing our programs.
+Added: We will be required to demonstrate thorough, adequate, and well controlled clinical trials that our product candidates are safe and effective, with a favorable benefit-risk profile, for use in its target indication before we can seek regulatory approvals for its commercial sale.
Our initial clinical trials will begin with relatively small cohorts before expanding in size in subsequent cohorts .
If safety issues arise in an early cohort, we may be delayed or prevented from subsequently expanding into larger trial cohorts.
−Removed: Our ability to generate product revenue, which we do not expect will occur for many years, if ever, will depend heavily on the successful clinical development and eventual commercialization of OKI-219.
We are not permitted to market or promote any product candidate before we receive marketing approval from the FDA, European Medicines Agency (“EMA”) or any comparable foreign regulatory authorities, and we may never receive such marketing approvals.
−Removed: We have limited resources and are currently focusing our efforts on OKI-219 for development in particular indications and advancing our other discovery research programs.
+Added: We have limited resources and are currently focusing our efforts on advancing OKI-345 or OKI-355 and our research programs.
As a result, we may fail to capitalize on programs, product candidates or indications that may be more profitable or for which there is a greater likelihood of success.
−Removed: We are currently focusing our resources and efforts on OKI-219 and advancing our other research programs.
−Removed: Because we have limited financial and managerial resources, we must focus on a limited number of research programs and product candidates and on specific indications.
+Added: We are currently focusing our resources and efforts on advancing OKI-345 or OKI-355 and our research programs.
+Added: Because we have limited financial and managerial resources, we must focus on a limited number of product candidates and research programs and on specific indications.
As a result, we may forgo or delay pursuit of opportunities for other indications or with other product candidates that may have greater commercial potential.
+Added: For example, we have decided not to pursue further clinical development of OKI-219 independently at this time.
Our resource allocation decisions may cause us to fail to capitalize on viable commercial products or profitable market opportunities.
−Removed: Our spending on current and future research and development activities for OKI-219 and our other research programs may not yield any commercially viable products.
−Removed: If we do not accurately evaluate the commercial potential or target markets for OKI-219 and our other research programs, or the product candidates we are currently developing in these programs, we may relinquish valuable rights to our product candidates or programs through collaboration, licensing or other strategic arrangements in cases in which it would have been more advantageous for us to retain sole development and commercialization rights to such product candidate or program .
+Added: Our spending on current and future research and development activities for OKI-345, OKI-355 and our research programs may not yield any commercially viable products.
+Added: If we do not accurately evaluate the commercial potential or target markets for OKI-345, OKI-355 and our research programs, or the product candidates we are currently developing in these programs, we may relinquish valuable rights to our product candidates or programs through collaboration, licensing or other strategic arrangements in cases in which it would have been more advantageous for us to retain sole development and commercialization rights to such product candidate or program .
If clinical trials of our product candidates fail to demonstrate safety and efficacy to the satisfaction of regulatory authorities or do not otherwise produce positive results, we would incur additional costs or experience delays in completing, or ultimately be unable to complete, the development and commercialization of our product candidates.
39 unchanged sentences
In addition, even if clinical trials are successfully completed, we cannot guarantee that the FDA or foreign regulatory authorities will interpret the results as we do, and more trials could be required before we submit our product candidates for approval.
−Removed: For example, although we have sought and received feedback from the FDA on the designs of our clinical trials and intend to continue to do so, the FDA may ultimately disagree that our trials support approval for OKI-219.
Moreover, results acceptable to support approval in one jurisdiction may be deemed inadequate by another regulatory authority to support regulatory approval in that other jurisdiction.
25 unchanged sentences
The FDA has also increased its scrutiny of foreign drug manufacturing facilities and other contractors based in China, especially with respect to the transfer of biological materials, genetic data, and other sensitive data of American patients to parties located in China.
−Removed: FDA’s “real-time” release of newly issued Complete Response Letters associated with withdrawn or abandoned applications, if applicable to any of our product candidates, can materially impact our competitive advantage and intellectual
−Removed: There is significant uncertainty in the industry around how federal agencies like the FDA will change in the coming years under the current administration.
+Added: FDA’s “real-time” release of newly issued Complete Response Letters associated with withdrawn or abandoned applications, if applicable to any of our product candidates, can materially impact our competitive advantage and intellectual property.
+Added: There is significant uncertainty in the industry around how federal agencies like the FDA will change in
+Added: the coming years under the current administration.
It is unclear how our industry and our clinical programs will be affected by policies and regulations implemented under the current administration and FDA commissioner, or other executive orders.
16 unchanged sentences
Patient enrollment is a significant factor in the timing of clinical trials.
−Removed: While our Phase 1 dose-escalation and expansion cohort trial, OKI-219-101, known as PIKture-01, has begun enrollment, future difficulties we experience relating to enrollment in our clinical trials, or complications in the PIKture-01 trial or future clinical trials, could delay regulatory approval for OKI-219 or our future product candidates.
+Added: Difficulties we experience relating to enrollment in our planned clinical trials, or complications in such clinical trials, could delay regulatory approval for our product candidates.
Patient enrollment may be affected if our competitors have ongoing clinical trials for product candidates that are under development for the same indications as our product candidates, and subjects who would otherwise be eligible for our clinical trials instead enroll in clinical trials of our competitors’ product candidates.
30 unchanged sentences
Some potential therapeutics developed in the biotechnology industry that initially showed therapeutic promise in early-stage trials have later been found to cause side effects that prevented their further development.
−Removed: Even if the side effects do not preclude the product candidate from obtaining or maintaining marketing approval, undesirable side effects may inhibit market acceptance due to its tolerability versus other therapies.
+Added: Even if the side effects do not preclude the product candidate from obtaining or maintaining marketing
+Added: approval, undesirable side effects may inhibit market acceptance due to its tolerability versus other therapies.
Any of these developments could materially harm our business, financial condition, and prospects.
5 unchanged sentences
For example, we previously decided to cease developing another product candidate, known as OKI-179, despite promising early data.
−Removed: In addition, in December 2024, we announced preliminary safety, tolerability and PK data from PIKture-01, with a cutoff date of October 28, 2024, which supported our initiation of Part 1b of PIKture-01.
−Removed: These data are considered preliminary and do not include efficacy data.
−Removed: We plan to provide additional data in the first quarter of 2026.
−Removed: We cannot predict whether these additional data will be consistent with the preliminary data announced in December 2024, or whether the data will be positive or consistent with our preliminary data.
−Removed: If the additional data from PIKture-01 are not positive or fail to support further advancement of OKI-219, we could experience volatility or a substantial decline in our stock price.
−Removed: Further, even if such data are positive and we decide to pursue future clinical trials of OKI-219, these trials may not be successful.
Product candidates in later-stage clinical trials may fail to demonstrate sufficient safety and efficacy to the satisfaction of the FDA and other comparable foreign regulatory authorities despite having progressed through preclinical studies and early-stage clinical trials.
4 unchanged sentences
This subjectivity can increase the uncertainty of, and adversely impact, our clinical trial outcomes.
−Removed: We may also experience issues in conducting our clinical trials that would delay or prevent us from satisfying the applicable requirements of the FDA and other regulatory authorities, including:
−Removed: inability to generate sufficient preclinical, toxicology, or other in vivo or in vitro data to support the initiation of clinical trials for any future product candidates;
+Added: We may also experience issues in conducting clinical trials that would delay or prevent us from satisfying the applicable requirements of the FDA and other regulatory authorities, including:
+Added: inability to generate sufficient preclinical, toxicology, or other in vivo or in vitro data to support the initiation of clinical trials;
delays in sufficiently developing, characterizing or controlling a manufacturing process suitable for advanced clinical trials;
30 unchanged sentences
As a result, the top-line or preliminary results that we report may differ from future results of the same studies or trials, or different conclusions or considerations may qualify such results, once additional data have been received and fully evaluated.
−Removed: For example, in December 2024, we announced preliminary safety, tolerability and PK data from PIKture-01, with a cutoff date of October 28, 2024, which supported our initiation of Part 1b of PIKture-01.
−Removed: These data are considered preliminary and do not include efficacy data.
−Removed: We plan to provide additional data in the first quarter of 2026.
−Removed: We cannot predict whether these additional data will be consistent with the preliminary data announced in December 2024, or whether the data will be positive or consistent with our preliminary data.
−Removed: If the additional data from PIKture-01 are not positive or fail to support further advancement of OKI-219, we could experience volatility or a substantial decline in our stock price.
−Removed: Further, even if such data are positive and we decide to pursue future clinical trials of OKI-219, these trials may not be successful.
Further, others, including regulatory agencies, may not accept or agree with our assumptions, estimates, calculations, conclusions, or analyses, or may interpret or weigh the importance of data differently, which could impact the value of the particular program or the approvability or commercialization of the particular product candidate and could have a material adverse effect on the success of our business.
1 unchanged sentence
If the interim, top-line, or preliminary data that we report differ from actual results, or if others, including regulatory authorities, disagree with the conclusions reached, our ability to obtain approval for and commercialize our product candidates may be harmed, which could harm our business, results of operations, prospects or financial condition.
−Removed: Further, disclosure of interim, top-line, or preliminary data by us or by our competitors could result in volatility in the price of our Class A Common Stock.
+Added: Further, disclosure of interim, top-line, or preliminary data by us or by our competitors could result in volatility in the price of our Common Stock.
Changes in methods of product candidate manufacturing or formulation may result in additional costs or delay.
4 unchanged sentences
We may develop programs in combination with other therapies, which exposes us to additional risks.
−Removed: We intend to develop OKI-219, and may develop any other product candidate we develop, in combination with one or more currently approved cancer therapies or therapies in development.
+Added: We intend to develop OKI-345 and OKI-355 and may develop other product candidates, in combination with one or more currently approved cancer therapies or therapies in development.
Patients may not be able to tolerate our product candidates in combination with other therapies, or dosing of our product candidates in combination with other therapies may have unexpected consequences.
13 unchanged sentences
As a result of these factors, our competitors may succeed in obtaining approval from the FDA, EMA, or other comparable foreign regulatory authorities or in discovering, developing, and commercializing product candidates in our field before we do.
−Removed: There are multiple PI3Kα-pathway targeted agents either approved or under clinical development that will potentially compete with OKI-219 and our PI3Kα-targeted portfolio.
+Added: There are multiple PI3Kα-pathway targeted agents either approved or under clinical development that will potentially compete with our PI3Kα-targeted portfolio.
Alpelisib (Piqray, a PI3Kα-selective inhibitor marketed by Novartis) and capivasertib (Truqap, an AKT1 inhibitor marketed by AstraZeneca) are marketed medicines, both of which are approved for the treatment of PI3Kα-mutated breast cancer patients in combination with the selective estrogen receptor degrader (“SERD”) fulvestrant.
3 unchanged sentences
MEN1611 (Menarini) and TOS-358 (Totus Medicines) and inhibitors designed to have greater selectivity for mutated PI3Kα, including RLY-2608 (Relay Therapeutics), STX-478 (LLY4064809) (Loxo Oncology), and SNV4818 (Synnovation Therapeutics).
−Removed: Multiple other companies have disclosed or published research efforts in PI3K inhibitors that are at an early stage,
−Removed: but could potentially advance to the clinical trial stage.
+Added: Multiple other companies have disclosed or published research efforts in PI3K inhibitors that are at an early stage, but could potentially advance to the clinical trial stage.
Finally, there are numerous other investigational therapies, spanning many modalities that are being evaluated preclinically and in clinical trials for breast cancer.
3 unchanged sentences
If we are unable to compete effectively, our opportunity to generate revenue from the sale of our product candidates, if approved, could be adversely affected.
−Removed: Even if OKI-219 or any other product candidate receives marketing approval, they may fail to achieve market acceptance among physicians, patients, third-party payors, and others in the medical community.
−Removed: If OKI-219 or any other product candidate that we develop receives marketing approval, it may nonetheless fail to gain sufficient market acceptance by physicians, patients, third-party payors, and others in the medical community.
−Removed: The degree of market acceptance of OKI-219 or any other product candidate that we develop, if approved for commercial sale, will depend on a number of factors, including:
+Added: Even if OKI-219, OKI-345, OKI-355 or any other product candidate receives marketing approval, they may fail to achieve market acceptance among physicians, patients, third-party payors, and others in the medical community.
+Added: If OKI-219, OKI-345, OKI-355 or any other product candidate that we develop receives marketing approval, it may nonetheless fail to gain sufficient market acceptance by physicians, patients, third-party payors, and others in the medical community.
+Added: The degree of market acceptance of OKI-219, OKI-345, OKI-355 or any other product candidate that we develop, if approved for commercial sale, will depend on a number of factors, including:
the efficacy and potential advantages of our product candidates compared to alternative treatments, including the existing standard-of-care;
14 unchanged sentences
If we are unable to establish sales and marketing capabilities or enter into agreements with third parties to sell and market our product candidates on acceptable terms, we may be unable to successfully commercialize our product candidates that obtain regulatory approval.
−Removed: If OKI-219 or another product candidate is approved, we must build marketing, sales, distribution, managerial, and other non-technical capabilities or make arrangements with third parties to perform these services for each of the territories in which we intend to sell and market our product candidates.
+Added: If any of our product candidates is approved, we must build marketing, sales, distribution, managerial, and other non-technical capabilities or make arrangements with third parties to perform these services for each of the territories in which we intend to sell and market our product candidates.
We may not be successful in accomplishing these required tasks.
2 unchanged sentences
Alternatively, if we choose to collaborate, either globally or on a territory-by-territory basis, with third parties that have direct sales forces and established distribution systems, either to augment our own sales force and distribution systems or in lieu of our own sales force and distribution systems, we will be required to negotiate and enter into arrangements with such third parties relating to the proposed collaboration.
−Removed: If we are unable to enter into such arrangements when needed, on acceptable terms, or at all, we may not be able to successfully commercialize any of our product candidates that receive regulatory approval, or any such commercialization may experience delays or limitations.
−Removed: If we are unable to successfully commercialize our approved product candidates, either on our own or through collaborations with one or more third parties, our future product revenue will suffer, and we may incur significant additional losses.
+Added: are unable to enter into such arrangements when needed, on acceptable terms, or at all, we may not be able to successfully commercialize any of our product candidates that receive regulatory approval, or any such commercialization may experience delays or limitations.
+Added: If we are unable to successfully commercialize any approved product candidates, either on our own or through collaborations with one or more third parties, our future product revenue will suffer, and we may incur significant additional losses.
If product liability lawsuits are brought against us, we may incur substantial liabilities and may be required to limit commercialization of our products, if approved.
5 unchanged sentences
We currently have product liability insurance that we believe is appropriate for our stage of development and may need to obtain higher levels prior to marketing any of our product candidates, if approved.
−Removed: Any insurance we have or may obtain may not provide sufficient coverage against potential liabilities and, if judgments exceed our insurance coverage, could adversely affect our results of operations and business and cause the price of our Class A Common Stock to decline.
+Added: Any insurance we have or may obtain may not provide sufficient coverage against potential liabilities and, if judgments exceed our insurance coverage, could adversely affect our results of operations and business and cause the price of our Common Stock to decline.
Furthermore, clinical trial and product liability insurance is becoming increasingly expensive.
6 unchanged sentences
Coverage and reimbursement may impact the demand for, or the price of, any product candidate for which we obtain marketing approval.
−Removed: If coverage and reimbursement are not available or reimbursement is available
−Removed: only to limited levels, we may not successfully commercialize any product candidate for which we obtain marketing approval.
+Added: If coverage and reimbursement are not available or reimbursement is available only to limited levels, we may not successfully commercialize any product candidate for which we obtain marketing approval.
There is significant uncertainty related to third-party payor coverage and reimbursement of newly approved products.
7 unchanged sentences
Further, such payors are increasingly challenging the price, examining the medical necessity, and reviewing the cost effectiveness of medical product candidates.
−Removed: There may be especially significant delays in obtaining coverage and reimbursement for newly approved drugs.
+Added: There may be especially significant delays in obtaining coverage and reimbursement for newly
+Added: approved drugs.
Third-party payors may limit coverage to specific product candidates on an approved list, known as a formulary, which might not include all FDA-approved drugs for a particular indication.
32 unchanged sentences
For example, following Russia’s invasion of Ukraine, the United States and other countries imposed economic sanctions and severe export control restrictions against Russia, Belarus and the occupied regions of Ukraine.
−Removed: The situation continues to evolve, and the United States, the EU, the United Kingdom, and other countries may implement additional sanctions, export controls, or other measures against Russia and other countries, regions, officials, individuals, companies, or industries in the respective territories, as well as entities or individuals in other countries that are providing support to the sanctioned parties.
+Added: The situation continues to evolve, and the United States, the EU, the United Kingdom, and other countries have implemented and may continue to implement additional sanctions, export controls, or other measures against Russia and other countries, regions, officials, individuals, companies, or industries in the respective territories, as well as entities or individuals in other countries that are providing support to the sanctioned parties.
Such sanctions and measures, as well as existing and potential further responses from Russia or other countries, could adversely affect the global economy and financial markets, as well as our business, financial condition, and results of operations, which may also magnify the impact of other risks described in this “Risk Factors” section.
−Removed: There is also currently significant uncertainty about the future relationship between the United States and various other countries, most significantly China, with respect to trade policies, treaties, trade regulations, and tariffs, and such uncertainty could continue under the current U.S.
−Removed: presidential administration.
−Removed: In February 2025, the administration stated its intent to modify U.S.
+Added: There is also currently significant uncertainty about the future relationship between the United States and various other countries, including China, with respect to trade policies, treaties, trade regulations, and tariffs.
+Added: In February 2025, the current U.S.
+Added: presidential administration stated its intent to modify U.S.
trade policy and, in some cases, to renegotiate, or potentially terminate, certain existing bilateral or multilateral trade agreements.
−Removed: The administration has imposed a baseline tariff of 10% on virtually all imports and higher country-specific tariffs on China and other countries, including countries in the European Union.
−Removed: Commerce Department is also currently conducting a targeted investigation related to imports of pharmaceuticals and pharmaceutical ingredients under section 232 of the Trade Expansion Act of 1962 which could result in tariffs on imports of finished drug products, medical countermeasures, critical inputs such as active pharmaceutical ingredients, and key starting materials, and derivative products of those items.
+Added: Beginning that month, the administration imposed “fentanyl-related” tariffs of 10-35% on imported products of China, Canada, and Mexico, with an exception for goods that qualify for duty-free treatment under the U.S.-Mexico-Canada Agreement.
+Added: Beginning in April 2025, the administration also imposed “reciprocal” tariffs of 10% or more on imports from almost all U.S.
+Added: trading partners other than Canada and Mexico, including China and the European Union.
+Added: Both of the foregoing tariffs were implemented under authorities asserted under the International Emergency Economic Powers Act (“IEEPA”) and rescinded on February 24, 2026, following a Supreme Court decision invalidating the use of IEEPA to authorize these tariffs.
+Added: Though the U.S.
+Added: government has begun rolling out a system to automate the process of refunding payments made in connection with the IEEPA tariffs, the availability, timing, and amount of any related refunds associated with payments of these tariffs remain uncertain and subject to further legal, regulatory, and administrative action.
+Added: Beginning February 24, 2026, the U.S.
+Added: government implemented a new, global “temporary import surcharge” of 10% on many of the same products affected by the prior reciprocal tariffs, under authorities provided for in Section 122 of the Trade Act of 1974.
+Added: These tariffs supplement existing non-IEEPA tariff measures, including those already imposed under authorities provided in Section 232 of the Trade Expansion Act of 1962 and Section 301 of the Trade Act of 1974.
+Added: For example, the U.S.
+Added: government announced in April 2026 that it would impose a new Section 232 tariff of up to 100% on certain patented or branded pharmaceuticals and pharmaceutical products beginning in July 2026.
+Added: Commerce Department is currently conducting targeted investigations related to national security risks associated with imports of certain items under Section 232 which could result in additional tariffs on imports of those items.
+Added: In addition, the U.S.
+Added: Trade Representative is conducting investigations related to the trade policies and actions of certain U.S.
+Added: trading partners, including China, the EU, Singapore, Switzerland, Norway, Indonesia, Malaysia, Cambodia, Thailand, South Korea, Vietnam, Taiwan, Bangladesh, Mexico, Japan, and India, which could result in additional tariffs on imports from those countries.
The administration continues to implement new, reinstated, or adjusted tariffs, and we expect that the administration will continue with this practice.
−Removed: These tariffs (and the uncertainty around their implementation) could affect inputs to our products, as well as equipment, materials, or components that we import into the United States from our suppliers,
−Removed: which could significantly impact the cost of these items.
+Added: These tariffs (and the uncertainty around their implementation) could affect inputs to our products, as well as equipment, materials, or components that we import into the United States from our suppliers, which could significantly impact the cost of these items.
Retaliatory tariffs and trade barriers could also negatively affect our ability to export and sell our potential products into those countries.
−Removed: If these tariffs are implemented, reinstated or adjusted, if additional tariffs are placed, or if any related countermeasures are taken by China, the European Union, or other countries, our business, financial condition, and results of operations may be materially harmed.
+Added: tariffs are implemented, reinstated or adjusted, if additional tariffs are placed, or if any related countermeasures are taken by China, the European Union, or other countries, our business, financial condition, and results of operations may be materially harmed.
Trade restrictions, tariffs, and other general economic or political conditions may limit our ability to obtain key materials, components, or equipment for our products or significantly increase supply chain costs and other expenses associated with our business, which could further materially and adversely affect our results of operations, financial condition, and prospects.
10 unchanged sentences
Risks Related to Our Intellectual Property
−Removed: If we are unable to obtain and maintain sufficient intellectual property protection for our technology and products and product candidates we may develop, or if the scope of the intellectual property protection obtained is not sufficiently broad, our competitors or other third parties could develop and commercialize products similar or identical to ours, and our ability to successfully develop and, if approved, commercialize our product candidates may be adversely affected.
+Added: If we are unable to obtain and maintain sufficient intellectual property protection for our technology and product candidates, or if the scope of the intellectual property protection obtained is not sufficiently broad, our competitors or other third parties could develop and commercialize products similar or identical to ours, and our ability to successfully develop and, if approved, commercialize our product candidates may be adversely affected.
We rely upon a combination of patents, trademarks, trade secret protection and confidentiality agreements to protect the intellectual property related to our development programs and product candidates.
−Removed: Our success depends in part on our ability to obtain and maintain patent protection in the United States and other countries with respect to OKI-219 and any future product candidates.
+Added: Our success depends in part on our ability to obtain and maintain patent protection in the United States and other countries with respect to OKI-219, OKI-345, OKI-355 and any future product candidates.
We seek to protect our proprietary position by filing patent applications in the United States and abroad related to our development programs, product candidates and novel discoveries that are important to our business.
The patent prosecution process is expensive and time-consuming, and we may not be able to file, prosecute, enforce or license all necessary or desirable patent applications at a reasonable cost or in a timely manner.
−Removed: The patents and patent applications that we own may fail to result in issued patents with claims that protect OKI-219 or any future product candidate in the United States or in other foreign countries.
+Added: The patents and patent applications that we own may fail to result in issued patents with claims that protect OKI-219, OKI-345, OKI-355 or any future product candidate in the United States or in other foreign countries.
There is no assurance that all of the potentially relevant prior art relating to our patents and patent applications has been found, which can prevent a patent from issuing from a pending patent application, or be used to invalidate a patent.
−Removed: Even if patents do successfully issue and even if such patents cover OKI-219 or any future product candidate, third parties may challenge their validity, enforceability or scope, which may result in such patents being narrowed, invalidated or held unenforceable.
+Added: Even if patents do successfully issue and even if such patents cover OKI-219, OKI-345, OKI-355 or any future product candidate, third parties may challenge their validity, enforceability or scope, which may result in such patents being narrowed, invalidated or held unenforceable.
Any successful opposition to these patents or any other patents owned by or licensed to us could deprive us of rights necessary for the successful commercialization of any product candidates that we may develop.
5 unchanged sentences
the USPTO requires us to disclose all material references to the patent examiner during prosecution of our patent applications, and failure to do so could result in a third party successfully challenging our ability to enforce a patent against an infringer;
−Removed: patent applications may not result in any patents being issued;
+Added: patent applications may not result in any patents being issued or in patents with meaningful scope, coverage or exclusivity;
patents may be challenged, invalidated, modified, revoked, circumvented, found to be unenforceable or otherwise may not provide any competitive advantage;
11 unchanged sentences
If they fail to do so, this could cause us to lose rights in any applicable intellectual property that we in-license, and as a result our ability to develop and commercialize products or product candidates may be adversely affected, and we may be unable to prevent competitors from making, using and selling competing products.
−Removed: If the patent applications we hold or may in-license in the future with respect to our development programs and product candidates fail to issue, if their breadth or strength of protection is threatened, or if they fail to provide meaningful exclusivity for OKI-219 or any future product candidate, it could dissuade other companies from collaborating with us to develop product candidates, and threaten our ability to commercialize OKI-219 or future product candidates.
+Added: If the patent applications we hold or may in-license in the future with respect to our development programs and product candidates fail to issue, if their breadth or strength of protection is threatened, or if they fail to provide meaningful exclusivity for OKI-219, OKI-345, OKI-355 or any future product candidate, it could dissuade other companies from collaborating with us to develop product candidates, and threaten our ability to commercialize OKI-219, OKI-345, OKI-355 or future product candidates.
Any such outcome could have a materially adverse effect on our business.
1 unchanged sentence
Supreme Court decisions, which have increased uncertainties as to the ability to enforce patent rights in the future.
−Removed: In addition, the laws of foreign countries may not protect our
−Removed: rights to the same extent as the laws of the United States.
+Added: In addition, the laws of foreign countries may not protect our rights to the same extent as the laws of the United States.
For example, many countries restrict the patentability of methods of treatment of the human body.
−Removed: Publications in scientific literature often lag behind the actual discoveries, and patent applications in the United States and other jurisdictions are typically not published until 18 months after filing, or in some cases not at all.
+Added: Publications in scientific literature often lag behind the actual discoveries,
+Added: and patent applications in the United States and other jurisdictions are typically not published until 18 months after filing, or in some cases not at all.
Therefore, we cannot know with certainty whether we were the first to make the inventions claimed in our own patents or pending patent applications, or that we were the first to file for patent protection of such inventions.
27 unchanged sentences
Given the amount of time required for the development, testing and regulatory review of new product candidates, patents protecting such candidates might expire before or shortly after such product candidates are commercialized.
−Removed: Even if patents covering our product
−Removed: candidates are obtained, once the patent life has expired for a product, we may be open to competition from biosimilar or generic products.
−Removed: As a result, our patent portfolio may not provide us with sufficient rights to exclude others from commercializing product candidates similar or identical to ours.
+Added: Even if patents covering our product candidates are obtained, once the patent life has expired for a product, we may be open to competition from biosimilar or generic products.
+Added: As a result, our patent portfolio may not provide us with sufficient rights to exclude
+Added: others from commercializing product candidates similar or identical to ours.
Upon issuance in the United States, the term of a patent can be increased by patent term adjustment, which is based on certain delays caused by the USPTO, but this increase can be reduced or eliminated based on certain delays caused by the patent applicant during patent prosecution.
1 unchanged sentence
patent may also be shortened if the patent is terminally disclaimed over an earlier-filed patent.
−Removed: Depending upon the timing, duration and specifics of FDA marketing approval of OKI-219 and future product candidates, one or more of our U.S.
+Added: Depending upon the timing, duration and specifics of FDA marketing approval of OKI-219, OKI-345, OKI-355 and future product candidates, one or more of our U.S.
patents may be eligible for limited patent term restoration under the Drug Price Competition and Patent Term Restoration Act of 1984, referred to as the Hatch-Waxman Amendments.
14 unchanged sentences
Noncompliance events that could result in abandonment or lapse of patent rights include, but are not limited to, failure to timely file national and regional stage patent applications based on our international patent application, failure to respond to official actions within prescribed time limits, non-payment of fees and failure to properly legalize and submit formal documents.
−Removed: If we or any of our licensors fails to maintain the patents and patent applications covering OKI-219 or any future product candidate, our competitors may be able to enter the market, which would have an adverse effect on our business.
+Added: If we or any of our licensors fails to maintain the patents and patent applications covering OKI-219, OKI-345, OKI-355 or any future product candidate, our competitors may be able to enter the market, which would have an adverse effect on our business.
We may not identify relevant third-party patents or may incorrectly interpret the relevance, scope or expiration of a third-party patent, which might adversely affect our ability to develop and market our products.
As the biopharmaceutical industry expands and more patents are issued, the risk increases that our product candidates may be subject to claims of infringement of the patent rights of third parties.
−Removed: There can be no assurance that our operations do not, or will not in the future, infringe, misappropriate or otherwise violate existing or future third-party patents or other intellectual property rights.
+Added: There can be no assurance
+Added: that our operations do not, or will not in the future, infringe, misappropriate or otherwise violate existing or future third-party patents or other intellectual property rights.
Identification of third-party patent rights that may be relevant to our operations is difficult because patent searching is imperfect due to differences in terminology among patents, incomplete databases and the difficulty in assessing the meaning of patent claims.
14 unchanged sentences
Our determination of the expiration date of any patent in the United States or abroad that we consider relevant may be incorrect, and our failure to identify and correctly interpret relevant patents may negatively impact our ability to develop and market our products.
−Removed: We may become involved in third-party claims of intellectual property infringement, which may delay or prevent the development and commercialization of OKI-219 and any future product candidate.
+Added: We may become involved in third-party claims of intellectual property infringement, which may delay or prevent the development and commercialization of OKI-219, OKI-345, OKI-355 and any future product candidate.
Our commercial success depends in part on us avoiding infringement and other violations of the patents and proprietary rights of third parties.
4 unchanged sentences
Third parties may assert that we are infringing their patents or employing their proprietary technology without authorization.
−Removed: Also, there may be third-party patents or patent applications with claims to materials, formulations, methods of manufacture or methods for treatment related to the use or manufacture of our current and future product
+Added: Also, there may be third-party patents or patent applications with claims to materials, formulations, methods of manufacture or methods for treatment related to the use or manufacture of our current and future product candidates.
Because patent applications can take many years to issue, there may be currently pending patent applications which may later result in issued patents that our current or future product candidates may infringe.
13 unchanged sentences
If securities analysts or investors regard these announcements as negative, the perceived value of our existing products, programs or intellectual property could be diminished.
−Removed: Accordingly, the price of our Class A Common Stock may decline.
+Added: Accordingly, the price of our Common Stock may decline.
Such announcements could also harm our reputation or the market for our future products, which could have a material adverse effect on our business.
8 unchanged sentences
Grounds for an unenforceability assertion could be an allegation that someone connected with prosecution of the patent withheld relevant material information from the USPTO, or made a materially misleading statement, during prosecution.
−Removed: Third parties may also raise similar validity claims before the USPTO in post-grant proceedings such as ex parte reexaminations, inter partes review or post-grant review, or
−Removed: oppositions or similar proceedings outside the United States, in parallel with litigation or even outside the context of litigation.
+Added: Third parties may also raise similar validity claims before the USPTO in post-grant proceedings such as ex parte reexaminations, inter partes review or post-grant review, or oppositions or similar proceedings outside the United States, in parallel with litigation or even outside the context of litigation.
The outcome following legal assertions of invalidity and unenforceability is unpredictable.
−Removed: In any patent infringement proceeding, there is a risk that a court will decide that a patent of ours or a future licensor is invalid or unenforceable, in whole or in part, and that we do not have the right to stop the other party from using the invention at issue.
+Added: In any patent infringement proceeding, there is a risk that a court will decide that a patent of ours or a future licensor is invalid or
+Added: unenforceable, in whole or in part, and that we do not have the right to stop the other party from using the invention at issue.
There is also a risk that, even if the validity of such patents is upheld, the court will construe the patent’s claims narrowly or decide that we do not have the right to stop the other party from using the invention at issue on the grounds that our or any future licensors’ patent claims do not cover the invention, or decide that the other party’s use of our or any future licensors’ patented technology falls under the safe harbor to patent infringement under 35 U.S.C.
13 unchanged sentences
There could also be public announcements of the results of hearings, motions or other interim proceedings or developments.
−Removed: If securities analysts or investors perceive these results to be negative, it could have an adverse effect on the price of our Class A Common Stock.
+Added: If securities analysts or investors perceive these results to be negative, it could have an adverse effect on the price of our Common Stock.
Moreover, we cannot assure you that we will have sufficient financial or other resources to file and pursue such infringement claims, which typically last for years before they are concluded.
7 unchanged sentences
Obtaining, defending, maintaining and enforcing patents in the biopharmaceutical industry involves both technological and legal complexity and is therefore costly, time-consuming and inherently uncertain.
−Removed: Changes in either the patent laws or interpretation of the patent laws in the United States could increase the uncertainties and costs surrounding the prosecution of patent applications and the enforcement or defense of issued patents, and may diminish our ability to protect our inventions, obtain, maintain, enforce and protect our
−Removed: intellectual property rights and, more generally, could affect the value of our intellectual property or narrow the scope of our future owned and licensed patents.
+Added: Changes in either the patent laws or interpretation of the patent laws in the United States could increase the uncertainties and costs surrounding the prosecution of patent applications and the enforcement or defense of issued patents, and may diminish our ability to protect our inventions, obtain, maintain, enforce and protect our intellectual property rights and, more generally, could affect the value of our intellectual property or narrow the scope of our future owned and licensed patents.
The United States has enacted and implemented wide-ranging patent reform legislation.
−Removed: Supreme Court has ruled on several patent cases in recent years, either narrowing the scope of patent protection available in certain circumstances or weakening the rights of patent owners in certain situations.
+Added: Supreme Court has ruled on several patent cases in recent years, either narrowing the
+Added: scope of patent protection available in certain circumstances or weakening the rights of patent owners in certain situations.
In addition to increasing uncertainty with regard to our ability to obtain patents in the future, this combination of events has created uncertainty with respect to the value of patents, once obtained.
9 unchanged sentences
We may not be able to protect our intellectual property rights throughout the world, which could impair our business.
−Removed: Patents are of national or regional effect, and filing, prosecuting and defending patents covering OKI-219 and any future product candidate throughout the world would be prohibitively expensive.
+Added: Patents are of national or regional effect, and filing, prosecuting and defending patents covering OKI-219, OKI-345, OKI-355 and any future product candidate throughout the world would be prohibitively expensive.
In addition, the laws of some foreign countries do not protect intellectual property rights to the same extent as federal and state laws in the United States, even in jurisdictions in which we do pursue patent protection.
11 unchanged sentences
Furthermore, the laws of some foreign countries do not protect proprietary rights to the same extent or in the same manner as the laws within the United States.
−Removed: We may need to share our trade secrets and proprietary know-how with current or future partners, collaborators, contractors and others located in countries at heightened risk of
−Removed: theft of trade secrets, including through direct intrusion by private parties or foreign actors and those affiliated with or controlled by state actors.
+Added: We may need to share our trade secrets and proprietary know-how with current or future partners, collaborators, contractors and others located in countries at heightened risk of theft of trade secrets, including through direct intrusion by private parties or foreign actors and those affiliated with or controlled by state actors.
As a result, we may encounter significant problems in protecting and defending our intellectual property both in the United States and abroad.
−Removed: In addition, some courts inside and outside of the United States may be less willing or unwilling to protect trade secrets.
+Added: In addition, some courts inside and outside of the United
+Added: States may be less willing or unwilling to protect trade secrets.
If we choose to go to court to stop a third party from using any of our trade secrets, we may incur substantial costs.
8 unchanged sentences
If we are unable to prevent unauthorized material disclosure of our intellectual property to third parties, we will not be able to establish or maintain a competitive advantage in our market, which could materially adversely affect our business, operating results and financial condition.
−Removed: Because we expect to rely on third parties to manufacture OKI-219 and any future product candidates, and we expect to collaborate with third parties on the continuing development of OKI-219 and any future product candidates, we must, at times, share trade secrets with them.
+Added: Because we expect to rely on third parties to manufacture OKI-219, OKI-345, OKI-355 and any future product candidates, and we expect to collaborate with third parties on the continuing development of OKI-219, OKI-345, OKI-355 and any future product candidates, we must, at times, share trade secrets with them.
We also expect to conduct R&D programs that may require us to share trade secrets under the terms of our partnerships or agreements with CROs.
11 unchanged sentences
These lawsuits may consume our time and other resources even if we are successful.
−Removed: For example, significant elements of our products, including confidential aspects of sample preparation,
−Removed: methods of manufacturing, and related processes and software, are based on unpatented trade secrets.
−Removed: Although we take steps to protect our proprietary information and trade secrets, including through contractual means with our employees and consultants, third parties may independently develop substantially equivalent proprietary information and techniques or otherwise gain access to our trade secrets or disclose our technology.
+Added: For example, significant elements of our products, including confidential aspects of sample preparation, methods of manufacturing, and related processes and software, are based on unpatented trade secrets.
+Added: Although we take steps to protect our proprietary information and trade secrets, including through contractual means with our
+Added: employees and consultants, third parties may independently develop substantially equivalent proprietary information and techniques or otherwise gain access to our trade secrets or disclose our technology.
We may become subject to claims that our employees, consultants or independent contractors have wrongfully used or disclosed confidential information of their former employers or other third parties or claims asserting ownership of what we regard as our own intellectual property.
26 unchanged sentences
We may not be able to protect our rights to these trademarks and trade names, which we need to build name recognition among potential partners or customers in our markets of interest.
−Removed: At times, competitors may adopt trade names or trademarks similar to those of ours, thereby impeding our ability to build brand identity and possibly leading to market confusion.
+Added: At times, competitors may adopt trade
+Added: names or trademarks similar to those of ours, thereby impeding our ability to build brand identity and possibly leading to market confusion.
In addition, there could be potential trade name or trademark infringement claims brought by owners of other trademarks or trademarks that incorporate variations of our registered or unregistered trademarks or trade names.
83 unchanged sentences
Even if we were able to obtain a license, it could be non-exclusive, thereby giving our competitors and other third parties access to the same technologies licensed to us, and it could require us to make substantial licensing and royalty payments.
−Removed: Failure to obtain any necessary rights or licenses may detrimentally affect our planned development of our current or future product candidates and could
−Removed: increase the cost and extend the timelines associated with the development of such other product candidates, and we may have to abandon development of the relevant program or product candidate.
+Added: Failure to obtain any necessary rights or licenses may detrimentally affect our planned development of our current or future product candidates and could increase the cost and extend the timelines associated with the development of such other product candidates, and we may have to abandon development of the relevant program or product candidate.
Any of the foregoing could have a material adverse effect on our business, financial condition, results of operations and prospects.
43 unchanged sentences
If a prolonged government shutdown, a lapse of U.S.
−Removed: government appropriations, or other disruption occurs, or if global health or
−Removed: other concerns prevent the FDA or other regulatory authorities from conducting their regular inspections, reviews or other regulatory activities in a timely manner, it could significantly impact the ability of the FDA to timely review and process our regulatory submissions, which could have a material adverse effect on our business.
−Removed: Further, future government shutdowns or delays could impact our ability to access the public markets and obtain necessary capital in order to properly capitalize and continue our operations.
−Removed: Separately, in response to the COVID-19 pandemic, the FDA announced its intention to postpone most inspections of foreign and domestic manufacturing facilities at various points.
−Removed: Even though the FDA has since resumed standard inspection operations of domestic facilities, if a prolonged government shutdown occurs, either for global health related reasons or other reasons, preventing the FDA or other regulatory authorities from conducting business as usual or conducting inspections, reviews or other regulatory activities, it could significantly impact the ability of the FDA to timely review and process our regulatory submissions, which could have a material effect on our business.
+Added: government appropriations, or other disruption occurs, or if global health or other concerns prevent the FDA or other regulatory authorities from conducting their regular inspections, reviews or other regulatory activities in a timely manner, it could significantly impact the ability of the FDA to timely review and process our regulatory submissions, which could have a material adverse effect on our business.
+Added: Further, future
+Added: government shutdowns or delays could impact our ability to access the public markets and obtain necessary capital in order to properly capitalize and continue our operations.
+Added: If a prolonged government shutdown occurs, as it has previously, either for global health related reasons or other reasons, preventing the FDA or other regulatory authorities from conducting business as usual or conducting inspections, reviews or other regulatory activities, it could significantly impact the ability of the FDA to timely review and process our regulatory submissions, which could have a material effect on our business.
We may face difficulties from changes to current regulations and future legislation.
19 unchanged sentences
CMS has selected 15 additional Medicare Part D drugs for negotiated maximum fair pricing in 2027.
−Removed: For 2028, up to an
−Removed: additional 15 drugs, which may be covered under either Medicare Part B or Part D, will be selected, and for 2029 and subsequent years, up to 20 additional Part B or Part D drugs will be selected.
+Added: For 2028, up to an additional 15 drugs, which may be covered under either Medicare Part B or Part D, will be selected, and for 2029 and subsequent years, up to 20 additional Part B or Part D drugs will be selected.
However, various industry stakeholders, including pharmaceutical companies, the U.S.
Chamber of Commerce and the Pharmaceutical Research and Manufacturers of America, have initiated lawsuits against the federal government asserting that the price negotiation provisions of the IRA are unconstitutional.
−Removed: Further, the current administration has issued executive orders focused on decreasing prescription drug prices, including directing the Secretary of Health and Human Services to establish a mechanism through which American patients can buy drugs directly from manufacturers who sell at a most-favored-nation price and directing the U.S.
+Added: Further, the current administration has issued executive orders focused on decreasing prescription drug prices, including directing the Secretary of Health and Human
+Added: Services to establish a mechanism through which American patients can buy drugs directly from manufacturers who sell at a most-favored-nation price and directing the U.S.
Trade Representative and Secretary of Commerce to take action to ensure foreign countries are not engaged in practices that purposefully and unfairly undercut market prices and drive price hikes in the United States.
−Removed: In September and October 2025, the government announced the first agreements with two major pharmaceutical companies to bring American drug prices in line with the lowest paid by other developed nations, requiring the companies to offer medicines at a deep discount off the list price when selling directly to American patients.
−Removed: Such agreements and other government measures that use most-favored-nation pricing targets for prescription drugs, including the use of international pricing reference to set drug prices in the United States, or increase generic and biosimilar drug entry sooner than expected, could have a material adverse effect on our industry, ability to set adequate pricing for new drugs to recover R&D costs, or ability to attract potential investors and potential buyers in the future.
+Added: Government agreements with pharmaceutical companies and other government measures that use most-favored-nation pricing targets for prescription drugs, including the use of international pricing reference to set drug prices in the United States, or increase generic and biosimilar drug entry sooner than expected, could have a material adverse effect on our industry, ability to set adequate pricing for new drugs to recover R&D costs, or ability to attract potential investors and potential buyers in the future.
We cannot predict the full impact of the executive orders focused on reducing prescription drug prices or increasing domestic drug manufacturing capacity, or other measures that may be implemented by the current administration related to drug pricing, drug supply chains or manufacturing in the United States.
17 unchanged sentences
We cannot be sure to what extent these legislative and regulatory proposals will be implemented by the federal and state governments, whether additional legislative changes will be enacted, whether FDA regulations, guidance or interpretations will be changed or what the impact of such changes on the marketing approvals of our product candidates, if any, may be.
−Removed: In addition, increased scrutiny by Congress of the FDA’s approval process may significantly delay or prevent marketing approval, as well as subject us to more stringent product labeling and post-marketing testing and other requirements.
+Added: In addition, increased scrutiny
+Added: by Congress of the FDA’s approval process may significantly delay or prevent marketing approval, as well as subject us to more stringent product labeling and post-marketing testing and other requirements.
We may be subject to federal and state healthcare fraud and abuse laws, false claims laws, transparency laws and health information privacy and security laws, which could expose us to, among other things, criminal sanctions, civil penalties, contractual damages, reputational harm, administrative burdens, and diminished profits and future earnings.
12 unchanged sentences
When an entity is determined to have violated the federal civil FCA, the government may impose civil fines and penalties for each false claim, plus treble damages, and exclude the entity from participation in Medicare, Medicaid and other federal healthcare programs;
−Removed: HIPAA, which created new federal criminal statutes that prohibit knowingly and willfully executing, or attempting to execute, a scheme to defraud any healthcare benefit program or obtain, by means of false or fraudulent pretenses, representations or promises, any of the money or property owned by, or under the custody or control of, any healthcare benefit program, regardless of the payor (e.g., public or private) and knowingly and willfully falsifying, concealing or covering up by any trick or device a material fact or making any materially false statements in connection with the delivery of, or payment for, healthcare
−Removed: benefits, items or services relating to healthcare matters.
+Added: HIPAA, which created new federal criminal statutes that prohibit knowingly and willfully executing, or attempting to execute, a scheme to defraud any healthcare benefit program or obtain, by means of false or fraudulent pretenses, representations or promises, any of the money or property owned by, or under the custody or control of, any healthcare benefit program, regardless of the payor (e.g., public or private) and knowingly and willfully falsifying, concealing or covering up by any trick or device a material fact or making any materially false statements in connection with the delivery of, or payment for, healthcare benefits, items or services relating to healthcare matters.
Similar to the AKS, a person or entity can be found guilty of violating HIPAA without actual knowledge of the statute or specific intent to violate it;
−Removed: HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act of 2009 (“HITECH”), and their respective implementing regulations, which impose requirements on certain covered healthcare providers, health plans and healthcare clearinghouses as well as their respective business associates and their subcontractors that perform services for them that involve the use, or disclosure of, individually identifiable health information, relating to the privacy, security and transmission of individually identifiable health information without appropriate authorization.
+Added: HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act of 2009 (“HITECH”), and their respective implementing regulations, which impose requirements on certain covered healthcare providers, health plans and healthcare clearinghouses as well as their respective business associates and their subcontractors that perform services for them that involve the use, or disclosure of, individually identifiable health information, relating to the privacy, security and
+Added: transmission of individually identifiable health information without appropriate authorization.
HITECH also created new tiers of civil monetary penalties, amended HIPAA to make civil and criminal penalties directly applicable to business associates and gave state attorneys general new authority to file civil actions for damages or injunctions in federal courts to enforce the federal HIPAA laws and seek attorneys’ fees and costs associated with pursuing federal civil actions;
9 unchanged sentences
Our employees, independent contractors, consultants, commercial collaborators, principal investigators, CROs, suppliers, and vendors may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements.
−Removed: We are exposed to the risk that our employees, independent contractors, consultants, commercial collaborators, principal investigators, CROs, suppliers, and vendors may engage in misconduct or other improper
+Added: We are exposed to the risk that our employees, independent contractors, consultants, commercial collaborators, principal investigators, CROs, suppliers, and vendors may engage in misconduct or other improper activities.
Misconduct by these parties could include failures to comply with FDA regulations, provide accurate information to the FDA, comply with federal and state health care fraud and abuse laws and regulations, accurately report financial information or data, or disclose unauthorized activities to us.
1 unchanged sentence
These laws and regulations may restrict or prohibit a wide range of pricing, discounting, marketing and promotion, sales commission, customer incentive programs, and other business arrangements.
−Removed: Misconduct by these parties could also involve the improper use of information obtained in the course of clinical trials, which could result in regulatory sanctions and serious harm to our reputation.
+Added: Misconduct by these parties could also involve the improper use of information obtained in the course of clinical trials, which could result in regulatory sanctions and serious harm to
+Added: our reputation.
It is not always possible to identify and deter misconduct by these parties, and the precautions we take to detect and prevent this activity may not be effective in controlling unknown or unmanaged risks or losses or in protecting us from governmental investigations or other actions or lawsuits stemming from a failure to comply with these laws or regulations.
23 unchanged sentences
Restrictive laws and regulations govern the collection, use, transfer, and other processing of personal information.
−Removed: In conducting and enrolling patients in current or future clinical trials, we are subject to restrictions relating to privacy, data protection, and cybersecurity, and may be subject to additional restrictions associated with clinical
−Removed: operations in the future.
+Added: In conducting and enrolling patients in current or future clinical trials, we are subject to restrictions relating to privacy, data protection, and cybersecurity, and may be subject to additional restrictions associated with clinical operations in the future.
For example, the collection, use, storage, disclosure, transfer, or other processing of personal data regarding individuals in the EU, including personal health data, is subject to the General Data Protection Regulation (“GDPR”), which is wide-ranging in scope and imposes numerous requirements on companies that process personal data.
1 unchanged sentence
The GDPR also confers a private right of action on data subjects and consumer associations.
−Removed: Certain aspects of cross-border data transfers under the GDPR are uncertain as the result of legal proceedings in the EU, including a July 2020 decision by the Court of Justice for the European Union (“CJEU”) that invalidated the EU-U.S.
+Added: Certain aspects of cross-border data transfers under the GDPR are uncertain as the result of legal proceedings in the EU, including a July 2020 decision by the Court of Justice for the European Union (“CJEU”) that
+Added: invalidated the EU-U.S.
Privacy Shield and called into question the efficacy and legality of using standard contractual clauses (“SCCs”).
4 unchanged sentences
Further, aspects of data protection in the UK remain uncertain.
−Removed: On June 28, 2021, the European Commission issued an adequacy decision pursuant to which personal data generally may be transferred from the EU to the UK without restriction;
−Removed: however, this adequacy decision is subject to a four-year “sunset” period, after which it may be renewed.
−Removed: This decision may be revoked or modified at any time.
+Added: In 2021, the European Commission issued an adequacy decision pursuant to which personal data generally may be transferred from the EU to the UK without restriction.
+Added: This adequacy decision was renewed in December 2025 to extend through December 2031.
+Added: The UK’s adequacy determination may, however, be revoked or modified at any time.
Additionally, the UK’s Information Commissioner’s Office has issued standard contractual clauses to support personal data transfers out of the UK (“UK SCCs”).
10 unchanged sentences
states have also enacted laws and regulations addressing specific subject matter, such as Washington State’s My Health, My Data Act which, among other things, provides for a private right of action.
+Added: Department of Justice also has issued rules restricting, and imposing requirements in connection with, certain bulk transfers of sensitive personal information.
Compliance with U.S.
93 unchanged sentences
Despite the implementation of security measures in an effort to protect systems that store our information, given their size and complexity and the increasing amounts of information maintained on our internal information technology systems and external processing and storage (e.g., cloud) systems, and those of our third-party CROs, other contractors (including sites performing our current or future clinical trials), consultants and other third-party service providers, these systems are potentially vulnerable to breakdown or other damage or interruption.
−Removed: Our systems and the systems of third parties who support our operations are vulnerable to service interruptions, system malfunction, natural disasters, terrorism, war (such as the ongoing conflicts in the Middle East and between Ukraine and Russia), and telecommunication and electrical failures, as well as security breaches and incidents arising from or caused by inadvertent or intentional actions by our employees, contractors, consultants, business partners, or other third parties, or from cyberattacks by malicious third parties (including the deployment of harmful malware, ransomware, denial-of-service attacks, social engineering, and other means to affect service reliability and threaten the confidentiality, integrity, or availability of information), which may compromise our system infrastructure or lead to unauthorized access to or disruption of our or third-party systems and the unauthorized access to, misuse, disclosure, loss, destruction, alteration or dissemination of, or damage to, our data, including trade secrets or other confidential information, intellectual property, proprietary business information, and personal information.
+Added: Our systems and the systems of third parties who support our operations are vulnerable to service interruptions, system malfunction, natural disasters, terrorism, war (such as conflicts in the Middle East and between Ukraine and Russia), and telecommunication and electrical failures, as well as security breaches and incidents arising from or caused by inadvertent or intentional actions by our employees, contractors, consultants, business partners, or other third parties, or from cyberattacks by malicious third parties (including the deployment of harmful malware, ransomware, denial-of-service attacks, social engineering, and other means to affect service reliability and threaten the confidentiality, integrity, or availability of information), which may compromise our system infrastructure or lead to unauthorized access to or disruption of our or third-party systems and the unauthorized access to, misuse, disclosure, loss, destruction, alteration or dissemination of, or damage to, our data, including trade secrets or other confidential information, intellectual property, proprietary business information, and personal information.
For example, companies have experienced an increase in phishing and social engineering attacks in recent years.
1 unchanged sentence
As a result, we may have increased cyber security and data security risks, due to increased use of home wi-fi networks and virtual private networks.
−Removed: While we implement controls to reduce the risk of a
−Removed: resulting cyber security or data security incident or breach, we may experience data security incidents, and there is no guarantee that the measures we have implemented will be adequate to safeguard all systems and data, especially with some employees working from home or in a hybrid model where it is more difficult for us to monitor.
+Added: While we implement controls to reduce the risk of a resulting cyber
+Added: security or data security incident or breach, we may experience data security incidents, and there is no guarantee that the measures we have implemented will be adequate to safeguard all systems and data, especially with some employees working from home or in a hybrid model where it is more difficult for us to monitor.
Any disruption, security incident, or security breach resulting in any loss, destruction, unavailability, alteration or dissemination of, or damage to, our data (including confidential information) or other data we or any of our CROs, other contractors, consultants, potential future collaborators, or other third-party service providers maintain or otherwise process, or our applications, or for it to be believed or reported that any of these occurred, could result in us incurring liability and reputational damage, and the development and commercialization of our product candidates could be delayed.
7 unchanged sentences
There have been and may continue to be significant supply chain attacks and operational technology attacks globally, and we cannot guarantee that our systems or those of third-party service providers or other third parties that support us or our operations have not been breached or that they do not contain exploitable defects or bugs that could result in a security incident or breach of, or other disruption to, our systems or the systems of third parties that support us and our operations.
−Removed: To the extent that any disruption or security incident were to result in a loss, destruction or alteration of, or damage to, our data, or inappropriate disclosure of confidential or proprietary information, we could be exposed to litigation and governmental investigations, the further development and commercialization of our product candidates could be delayed, and we could be subject to significant fines or penalties for any noncompliance with certain state, federal or international laws relating to privacy, data protection, and information security.
−Removed: Litigation and governmental investigations could force us to spend money in defense or settlement, divert management’s time and attention, increase our costs of doing business, and adversely affect our reputation.
+Added: Any disruption or security incident may result in damage to, or loss, destruction, alteration, or other unauthorized processing of our data, or inappropriate disclosure of confidential or proprietary information, we could be exposed to litigation and governmental investigations and other proceedings and actions, delays in the development and commercialization of our product candidates, and subject us to significant fines, penalties, and other liabilities.
+Added: Litigation, governmental investigations, and other actions and proceedings could force us to spend money in defense or settlement, divert management’s time and attention, increase our costs of doing business, and adversely affect our reputation.
We could be required to fundamentally change our business activities and practices in response to such litigation or investigations, which could have an adverse effect on our business.
9 unchanged sentences
the timing and results of clinical trials for our current product candidates and any future product candidates that we may develop;
−Removed: commencement or termination of collaborations for our product development and research programs;
+Added: commencement or termination of collaborations for our product candidates and research programs;
failure to achieve development, regulatory or commercialization milestones under our collaborations;
−Removed: failure or discontinuation of any of our product development and research programs;
+Added: failure or discontinuation of any of our product candidates and research programs;
results of preclinical studies, clinical trials or regulatory approvals of product candidates of our competitors, or announcements about new research programs or product candidates of our competitors;
−Removed: the level of expenses related to any of our research programs, clinical development programs or product candidates;
+Added: the level of expenses related to any of our product candidates or research programs;
the results of our efforts to develop additional product candidates;
31 unchanged sentences
Even if we do achieve profitability, we may not be able to sustain or increase profitability on a quarterly or annual basis.
−Removed: We may be unable to successfully integrate the businesses of Reneo and Legacy OnKure and realize the anticipated benefits of the Merger.
−Removed: The Merger involved the combination of two companies that previously operated as independent companies.
−Removed: Following the Merger, we must devote significant management attention and resources to integrating the business practices and operations of the separate companies.
−Removed: We may fail to realize some or all of the anticipated benefits of the Merger if the integration process takes longer than expected or is more costly than expected.
−Removed: Potential difficulties in the integration process include the following:
−Removed: the inability to successfully combine the businesses of Reneo and OnKure in a manner that permits us to achieve the anticipated benefits from the Merger in the time frame currently anticipated or at all;
−Removed: creation of uniform standards, controls, procedures, policies, and information systems;
−Removed: potential unknown liabilities and unforeseen increased expenses, delays, or regulatory conditions associated with the Merger.
−Removed: Many of the other biotechnology companies that we compete against for qualified personnel have greater financial and other resources, different risk profiles, and a longer history in the industry than we do.
−Removed: competitors also may provide higher compensation, more diverse opportunities, and better prospects for career advancement.
−Removed: Some of these characteristics may be more appealing to high-quality candidates than what we have to offer.
−Removed: If we are unable to continue to attract and retain high-quality personnel, the rate and success at which we can discover, develop and commercialize our product candidates will be limited and the potential for successfully growing our business will be harmed.
If we fail to attract and retain management and other key personnel, we may be unable to continue to successfully develop or commercialize our product candidates or otherwise implement our business plan.
4 unchanged sentences
We might not be able to attract or retain qualified management and other key personnel in the future due to the intense competition for qualified personnel among biotechnology, pharmaceutical and other businesses.
−Removed: We will incur additional costs and increased demands upon management as a result of complying with the laws and regulations affecting public companies.
−Removed: We will incur significant legal, accounting and other expenses as a public company that Legacy OnKure did not incur as a private company, including costs associated with public company reporting obligations under the Exchange Act.
−Removed: Our management team consists of the executive officers of Legacy OnKure prior to the Merger, some of whom have not previously managed and operated a public company.
−Removed: These executive officers and other personnel will need to devote substantial time to gaining expertise related to public company reporting requirements and compliance with applicable laws and regulations to ensure that we comply with all of these requirements.
−Removed: Any changes we make to comply with these obligations may not be sufficient to allow us to satisfy our obligations as a public company on a timely basis, or at all.
+Added: We incur additional costs and increased demands upon management as a result of complying with the laws and regulations affecting public companies.
+Added: We incur significant legal, accounting and other expenses as a public company, including costs associated with public company reporting obligations under the Exchange Act.
+Added: Our management team, including executive officers and other personnel, need to devote substantial time to ensuring that we comply with applicable public company reporting requirements and applicable laws and regulations.
These reporting requirements, rules and regulations, coupled with the increase in potential litigation exposure associated with being a public company, could also make it more difficult for us to attract and retain qualified persons to serve on our Board or board committees or to serve as executive officers, or to obtain certain types of insurance, including directors’ and officers’ insurance, on acceptable terms.
4 unchanged sentences
It cannot be predicted if investors will find our Class A Common Stock less attractive because we may rely on these exemptions.
−Removed: If some investors find our Class A
−Removed: Common Stock less attractive as a result, there may be a less active trading market for our Class A Common Stock and the price of our Class A Common Stock may be more volatile.
+Added: If some investors find our Class A Common Stock less attractive as a result, there may be a less active trading market for our Class A Common Stock and the price of our Class A Common Stock may be more volatile.
Under the JOBS Act, emerging growth companies can also delay adopting new or revised accounting standards until such time as those standards apply to private companies.
7 unchanged sentences
The Sarbanes-Oxley Act requires, among other things, that we maintain effective disclosure controls and procedures and internal control over financial reporting.
−Removed: We must perform system and process evaluation and testing of our internal control over financial reporting to allow management to report on the effectiveness of our internal controls over financial reporting in our Annual Report on Form 10-K filing for that year, as required by Section 404 of the Sarbanes-Oxley Act.
−Removed: As a private company, Legacy OnKure was not required to test its internal controls within a specified period.
−Removed: This will require that we incur substantial professional fees and internal costs to expand our accounting and finance functions and that we expend significant management efforts.
+Added: We must perform system and process evaluation and testing of our internal control over financial reporting to allow management to report on the
+Added: effectiveness of our internal controls over financial reporting in our Annual Report on Form 10-K filing for that year, as required by Section 404 of the Sarbanes-Oxley Act.
+Added: This requires that we incur substantial professional fees and internal costs in connection with our accounting and finance functions and that we expend significant management efforts.
We may experience difficulty in meeting these reporting requirements in a timely manner.
−Removed: In addition to the matters described above in the context of Legacy OnKure being a private company, we may discover weaknesses in our system of internal financial and accounting controls and procedures that could result in a material misstatement of our financial statements.
+Added: We may discover weaknesses in our system of internal financial and accounting controls and procedures that could result in a material misstatement of our financial statements.
Our internal control over financial reporting will not prevent or detect all errors and all fraud.
17 unchanged sentences
require supermajority votes of the holders of our Common Stock to amend specified provisions of our Amended Certificate of Incorporation and Amended Bylaws.
−Removed: Moreover, because we are incorporated in Delaware, we are governed by the provisions of Section 203 of the DGCL, which prohibits stockholders owning in excess of 15% of our outstanding voting stock from merging or combining with us.
+Added: Moreover, because we are incorporated in Delaware, we are governed by the provisions of Section 203 of the DGCL, which prohibits stockholders owning in excess of 15% of our outstanding voting stock from merging or
+Added: combining with us.
Although we believe these provisions collectively will provide for an opportunity to receive higher bids by requiring potential acquirors to negotiate with the Board, they would apply even if the offer may be considered beneficial by some stockholders.
11 unchanged sentences
In addition, our Amended Bylaws provide that any person or entity purchasing or otherwise acquiring any interest in shares of our capital stock is deemed to have notice of and consented to these exclusive forum provisions.
−Removed: The forum selection provisions in our Amended Bylaws may limit our stockholders’ ability to litigate disputes with us in a judicial forum that they find favorable for disputes with us or our directors, officers or
−Removed: employees, which may discourage the filing of lawsuits against us and our directors, officers and employees, even though an action, if successful, might benefit our stockholders.
+Added: The forum selection provisions in our Amended Bylaws may limit our stockholders’ ability to litigate disputes with us in a judicial forum that they find favorable for disputes with us or our directors, officers or employees, which may discourage the filing of lawsuits against us and our directors, officers and employees, even though an action, if successful, might benefit our stockholders.
There is uncertainty as to whether a court would enforce such provisions, and investors cannot waive compliance with the federal securities laws and the rules and regulations thereunder.
17 unchanged sentences
As a result, capital appreciation, if any, of our Class A Common Stock will be your sole source of gain, if any, for the foreseeable future.
−Removed: A robust trading market for our Class A Common Stock may not develop, and the holders of our Class A Common Stock may not be able to resell their shares of our Class A Common Stock for a profit, if at all.
−Removed: Prior to the Merger, there had been no public market for shares of Legacy OnKure capital stock.
−Removed: A robust trading market for our Class A Common Stock may never develop or be sustained.
−Removed: If an active market for our Class A Common Stock does not develop or is not sustained, it may be difficult for our stockholders to sell their shares of our Class A Common Stock at an attractive price or at all.
We could be subject to securities class action litigation, which is expensive and could divert management attention.
11 unchanged sentences
investors who (i) were affiliates of OnKure at the time the Merger were submitted for the vote or consent of OnKure stockholders, (ii) received securities in the Merger and (iii) publicly offer or sell such securities will be deemed to be engaged in a distribution of such securities, and therefore would be underwriters with respect to resales of those securities, and accordingly such securities may not be included in the Form S-1 resale shelf registration statement that was filed after the closing of the Merger unless such securities are sold only in a fixed price offering in which such investors are named as underwriters in the prospectus;
−Removed: Rule 144(i)(2) limits the ability of holders of restricted securities and any affiliates of the public company to publicly resell Rule 145(c) securities per Rule 145(d), as well as any other of our “restricted” or “control” securities per Rule 144, until one year after the Super 8-K is filed with the SEC.
−Removed: Non-affiliate Reneo stockholders prior the Merger are not subject to such restrictions on public resales of their shares.
+Added: Rule 144(i)(2) limited the ability of holders of restricted securities and any affiliates of the public company to publicly resell Rule 145(c) securities per Rule 145(d), as well as any other of our “restricted” or “control” securities per Rule 144, until one year after the Super 8-K was filed with the SEC.
+Added: Non-affiliate Reneo stockholders prior the Merger were not subject to such restrictions on public resales of their shares.
The foregoing SEC requirements will increase our time and cost of raising capital, offering stock under equity plans, and complying with securities laws.
Furthermore, such requirements will add burdensome restrictions on the resale of our Class A Common Stock by our affiliates and any holders of our “restricted” or “control” securities.
+Added: We have issued a substantial number of pre-funded warrants which are exercisable into shares of our Class A Common Stock which could result in substantial dilution to the ownership interests of our existing stockholders.
+Added: Pursuant to the 2026 PIPE Purchase Agreement, we issued the 2026 PIPE Pre-Funded Warrants.
+Added: As of April 1, 2026, approximately 9,430,957 shares of our Class A Common Stock were reserved for issuance upon exercise of the 2026 PIPE Pre-Funded Warrants.
+Added: The exercise of these securities will result in a significant increase in the number of outstanding shares and substantially dilute the ownership interests of our existing stockholders.
Future sales of shares by existing stockholders could cause our Class A Common Stock price to decline.
−Removed: If existing securityholders sell, or indicate an intention to sell, substantial amounts of our Class A Common Stock in the public market after legal restrictions on resale lapse, the trading price of our Class A Common Stock could decline.
−Removed: Of the outstanding shares of our Class A Common Stock, approximately 6,733,253 shares became available for sale in the public market as a result of the expiration of lock-up agreements.
−Removed: All other outstanding shares of our Class A Common Stock, other than shares held by our affiliates, are also freely tradable, without restriction, in the public market.
+Added: Sales of a substantial number of our Class A Common Stock in the public market could occur at any time.
+Added: If existing securityholders sell, or indicate an intention to sell, substantial amounts of our Class A Common Stock in the public market, the trading price of our Class A Common Stock could decline.
+Added: All outstanding shares of our Class A Common Stock, other than shares held by our affiliates, are freely tradable, without restriction, in the public market.
+Added: For example, we registered all of the 36,144,595 shares of our Class A Common Stock issued (or issuable upon the exercise of the 2026 PIPE Pre-Funded Warrants) by us in the 2026 Private Placement on a Form S-3, which was declared effective by the SEC in May 2026.
In addition, shares of our Class A Common Stock that are subject to outstanding options or warrants will become eligible for sale in the public market to the extent permitted by the provisions of various vesting agreements and Rules 144 and 701 under the Securities Act.
1 unchanged sentence
Our executive officers, directors and principal stockholders have the ability to control or significantly influence all matters submitted to our stockholders for approval.
−Removed: As of September 30, 2025, our executive officers, directors and principal stockholders, in the aggregate, beneficially own approximately 36.1% of the outstanding shares of our Class A Common Stock.
+Added: As of April 1, 2026, our executive officers, directors and principal stockholders, in the aggregate, beneficially own approximately 60.4% of the outstanding shares of our Class A Common Stock.
As a result, if these stockholders were to choose to act together, they would be able to control or significantly influence all matters submitted to our stockholders for approval, as well as our management and affairs.
5 unchanged sentences
In the event that we do have equity research analyst coverage, we will not have any control over the analysts or the content and opinions included in their reports.
−Removed: The price of our Class A Common Stock could decline if one or more equity research analysts downgrades our stock or issues other unfavorable commentary or research.
+Added: The price of our Class A
+Added: Common Stock could decline if one or more equity research analysts downgrades our stock or issues other unfavorable commentary or research.
If one or more equity research analysts ceases coverage of us or fails to publish reports on it regularly, demand for our Class A Common Stock could decrease, which in turn could cause our stock price or trading volume to decline.
16 unchanged sentences
federal net operating loss carryforwards and other tax attributes may become subject to an annual limitation in the event of certain cumulative changes in ownership.
−Removed: An “ownership change” pursuant to Section 382 of the Code generally occurs if one or more stockholders or groups of stockholders who own at least 5% of a company’s stock
−Removed: increase their ownership by more than 50 percentage points (by value) over their lowest ownership percentage within a rolling three-year period.
+Added: An “ownership change” pursuant to Section 382 of the Code generally occurs if one or more stockholders or groups of stockholders who own at least 5% of a company’s stock increase their ownership by more than 50 percentage points (by value) over their lowest ownership percentage within a rolling three-year period.
Legacy OnKure had not conducted a study to determine whether such an ownership change had occurred in the previous years to impair the use of its net operating loss carryforwards.
−Removed: Reneo may have experienced such ownership changes in the past, and we believe that Reneo experienced an ownership change in connection with the Merger and the Concurrent Financing.
−Removed: Our ability to utilize these net operating loss carryforwards and other tax attributes to offset future taxable income or tax liabilities may be limited as a result of ownership changes, including, as discussed above, in connection with the Merger and the Concurrent Financing or other transactions.
+Added: Reneo may have experienced such ownership changes in the past, and we believe that Reneo experienced an ownership change in connection with the Merger and the private placement Reneo completed concurrently with the closing of the Merger.
+Added: Our ability to utilize these net operating loss carryforwards and other tax attributes to offset future taxable income or tax liabilities may be limited as a result of ownership changes, including, as discussed above, in connection with the Merger and the concurrent private placement or other transactions.
Similar rules may apply under state tax laws.
11 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.