What changed in this filing

/stocks — the workspaceLOADING

Item 1. Business

2026-02-24 compared with 2025-02-27 · 188 added, 146 removed, 858 unchanged (28% of the section changed)

1 unchanged sentence

Our goal is to target tumor vulnerabilities with treatment combinations of onvansertib, our oral and highly selective PLK1 inhibitor, and standard-of-care ("SoC") therapeutics.

We are focusing our clinical program in indications such as RAS-mutated metastatic colorectal cancer ("mCRC"), as well as in investigator-initiated ongoing or planned trials in metastatic pancreatic ductal adenocarcinoma ("mPDAC"), small cell lung cancer ("SCLC"), and triple negative breast cancer ("TNBC").

Our clinical development programs incorporate tumor genomics and biomarker assays to refine assessment of patient response to treatment.

We are focusing our clinical program in indications such as RAS-mutated metastatic colorectal cancer ("mCRC"), as well as in investigator-initiated trials in metastatic pancreatic ductal adenocarcinoma ("mPDAC"), small cell lung cancer ("SCLC"), metastatic triple negative breast cancer ("mTNBC") and Chronic Myelomonocytic Leukemia ("CMML").

Our clinical development programs incorporate tumor genomics and biomarker assays to refine patient selection and assessment of patient response to treatment.

Our Lead Drug Candidate, Onvansertib

9 unchanged sentences

Combining onvansertib with SoC cancer agents may provide opportunities for synergy with many cancer therapies.

There are several ongoing and planned clinical trials of onvansertib in multiple indications:

one trial (CRDF-004) in first-line treatment in patients with RAS-mutated mCRC, and investigator-initiated trials in first-line mPDAC, relapsed SCLC and unresectable locally advanced or metastatic TNBC.

There are several ongoing clinical trials of onvansertib in multiple indications:

one trial (CRDF-004) in first-line treatment in patients with RAS-mutated mCRC, and investigator-initiated trials in first-line mPDAC, relapsed SCLC, unresectable locally advanced or metastatic TNBC and CMML.

RAS-mutated mCRC Program:

CRDF-004 Randomized Clinical Trial in First-Line RAS-mutated mCRC

CRDF-004 is a Phase 2 open-label, randomized multi-center clinical trial of onvansertib in combination with SoC FOLFIRI and bevacizumab or SoC FOLFOX and bevacizumab for the first-line treatment of patients with RAS-mutated mCRC.

The primary objectives of the CRDF-004 trial are to evaluate onvansertib’s safety and efficacy in combination with the SoC, as well as to evaluate two doses of onvansertib, 20mg and 30mg, given in combination with SoC, against SoC alone.

The primary endpoint of the trial is objective response rate ("ORR").

Progression-free survival and duration of response will be secondary endpoints.

This trial is conducted in partnership with Pfizer Ignite, an end-to-end service for biotech companies, and it is expected to enroll approximately 90 evaluable patients.

CRDF-004 is a Phase 2 open-label, randomized multi-center clinical trial to assess the efficacy of two doses of onvansertib (20mg and 30mg) in combination with FOLFIRI and bevacizumab or FOLFOX and bevacizumab, compared with FOLFIRI or FOLFOX and bevacizumab (SOC) alone, for the treatment of confirmed metastatic and unresectable colorectal cancer (mCRC) in patients with a KRAS or NRAS mutation in the first-line setting.

Trial endpoints include objective response rate ("ORR"), progression-free survival ("PFS") and duration of response ("DoR") together with pharmacokinetics, and pharmacodynamics and safety assessments.

Selection of the recommended phase 3 onvansertib dose will be based on a benefit-risk assessment of the totality of the evidence,

including numerical differences between the onvansertib and SoC arms.

The trial enrolled 110 patients in the intent-to-treat ("ITT") population and is conducted in partnership with Pfizer Ignite, an end-to-end service for biotech companies.

For more information, please visit NCT06106308 at www.clinicialtrials.gov .

Contingent upon the results of CRDF-004, we plan to initiate CRDF-005, a Phase 3, randomized trial with registrational intent.

The FDA has agreed that a seamless trial with an interim endpoint of ORR, with duration of response, is acceptable to pursue accelerated approval, with progression-free survival and trend in overall survival being the endpoints for full approval.

Data presented on December 10, 2024 provided initial results from the ongoing CRDF-004 Phase 2 randomized clinical trial in first-line RAS-mutated metastatic colorectal cancer.

ORR, as of the data cut-off date of November 26, 2024, are shown below.

Control Arm (SoC alone)

20mg dose of onvansertib + SoC

30mg dose of onvansertib + SoC

All onvansertib patients

Spider Plots, displaying the change in tumor size from baseline for each patient over time, demonstrate deeper responses observed in patients receiving the 30mg dose of onvansertib in combination with the SoC compared to both the control arms and 20mg dose of onvansertib arms.

Radiographic response determined per RECIST 1.1 by blinded independent central review.

Spider plot reflects interim data as of November 26, 2024 from an ongoing trial and unlocked database.

Onvansertib in combination with chemo/bevacizumab was well-tolerated and there have been no major or unexpected toxicities observed.

Phase 1b/2 Clinical Trial in Second-Line KRAS-mutated mCRC

TROV-054, a Phase 1b/2 open-label multi-center clinical trial of onvansertib in combination with SoC FOLFIRI and bevacizumab for the second-line treatment of patients with KRAS-mutated mCRC, completed enrollment in October 2022.

The primary objectives of this trial were to evaluate the Dose-Limiting Toxicities ("DLTs"), maximum tolerated dose ("MTD") and recommended Phase 2 dose ("RP2D") of onvansertib in combination with FOLFIRI and bevacizumab (Phase 1b) and to continue to assess the safety and preliminary efficacy of onvansertib in combination with FOLFIRI and bevacizumab patients with KRAS-mutated mCRC (Phase 2).

For more information, please visit NCT03829410 at www.clinicialtrials.gov .

Data presented on August 7, 2023, provided an update of the ongoing TROV-054 Phase 1b/2 single arm clinical trial in KRAS-mutated metastatic colorectal cancer:

• ORR across all evaluable patients was 29%, with 19 of 66 evaluable patients achieving an objective response.

Responses have been observed across multiple KRAS variants;

• Median duration of response ("mDoR") across all evaluable patients was 12.0 months (95% confidence interval ("CI"):

8.9 – not reached);

• Median progression free survival ("mPFS") across all evaluable patients was 9.3 months (95% CI:

Historical control trials of different drug combinations, including the SoC of FOLFIRI with bevacizumab, in similar patient populations have shown ORR and mPFS of 5 – 13% and ~4.5 – 6.7 months, respectively;

• A subgroup analysis of patients who were bevacizumab naïve when they entered second-line therapy vs.

patients who had received prior bevacizumab in first-line therapy showed that patients who were bevacizumab naïve (n=15) had an ORR of 73% and mPFS of 15 months, which is well above historical controls.

In contrast, patients previously treated with bevacizumab (n=51) had an ORR of 16% and mPFS of 7.8 months;

• Data on Treatment Emergent Adverse Events ("TEAEs") on the trial showed that onvansertib is well-tolerated when used in combination with FOLFIRI and bevacizumab.

The more severe, grade 4 TEAEs are either neutropenia or leukopenia, which are common events in patients treated with FOLFIRI and bevacizumab.

None of the patients with grade 4 TEAEs discontinued treatment due to their condition and all resolved without issue.

There were no major or unexpected toxicities seen in the trial;

• Data from the Phase 1b portion of this trial was published in the peer-reviewed journal Clinical Cancer Research, February 6, 2024 edition;

• Data from the Phase 2 portion of this trial was published online in the peer-reviewed journal of Clinical Oncology on October 30, 2024.

Based on the interim results of the TROV-054 trial, we designed the ONSEMBLE trial (CRDF-003) as the next phase of our mCRC program.

Upon further review of the clinical data from the bevacizumab naïve subgroup (those patients who did not receive bevacizumab in their first-line therapy), the preclinical data on the mechanism of action and the feedback from the FDA on our clinical development strategy, we made the decision to discontinue enrollment in the ONSEMBLE trial and to initiate the CRDF-004 clinical trial.

Phase 2 Clinical Trial in Second-Line RAS-mutated mCRC

The ONSEMBLE trial (CRDF-003) was a Phase 2 randomized, open-label multi-center clinical trial of onvansertib in combination with SoC FOLFIRI and bevacizumab for the second-line treatment of patients with RAS-mutated mCRC.

The ONSEMBLE trial completed enrollment in August 2023 as part of our shift to a first-line mCRC program.

The primary objectives of the ONSEMBLE trial were to evaluate onvansertib’s safety and efficacy in combination with FOLFIRI and bevacizumab, as well as to evaluate two doses of onvansertib, 20mg and 30mg, given in combination with FOLFIRI and bevacizumab, against FOLFIRI and bevacizumab alone.

The primary endpoint of the trial was ORR.

For more information, please visit NCT05593328 at www.clinicialtrials.gov .

The ORR data from the randomized ONSEMBLE trial validates the findings observed in our earlier single-arm Phase 1b/2 KRAS-mutated mCRC trial (TROV-054).

In the ONSEMBLE trial, objective responses were observed only in bevacizumab naïve patients, not bevacizumab exposed patients.

In addition, these objective responses were present only in bevacizumab naïve patients randomized to the experimental arms of onvansertib in combination with FOLFIRI and bevacizumab versus bevacizumab naïve patients randomized to the FOLFIRI and bevacizumab alone control arm.

mPDAC Program:

The FDA agreed at a Type C meeting in June 2023 that a seamless trial with an interim endpoint of ORR, with DoR, is acceptable to pursue accelerated approval, with PFS and lack of detriment on overall survival being the endpoints for full approval.

The complete Phase 3 trial design will be finalized after discussion with the FDA upon sharing the full CRDF-004 trial results.

Data provided in the press release dated January 27, 2026 included updated data from the ongoing CRDF-004 Phase 2 randomized clinical trial in first-line RAS-mutated mCRC.

The results as of the data cut-off date of January 22, 2026, are shown below.

SoC c (FOLFIRI/bev+FOLFOX/bev) (n=37)

Objective Response Rate (per BICR) a

Confirmed Responders

Confirmed ORR (%)

p-value = 0.051 f (vs SoC)

Progression Free Survival b

Median PFS (months, 95% CI)

10.97 (9.43-15.44)

10.97 (7.52-NR)

PFS HR (vs FOLFIRI/bev)

0.56 (0.18-1.73) d

0.38 (0.12-1.17) d

PFS HR (vs SoC)

0.57 (0.21-1.58) e

0.37 (0.13-1.02) e

p-value = 0.048 g (vs SoC)

PFS Rate at 6 months (95% CI)

88.8 (77.4-100)

79.5 (61.1-100)

88.1 (73.9-100)

94.1 (83.6-100)

Bev=bevacizumab;

BICR=Blinded Independent Central Review;

CI=confidence interval;

HR=hazard ratio;

NR=not reached;

Onv=onvansertib;

ORR=objective response rate;

PFS=progression-free survival;

SoC=standard of care.

a ORR is confirmed responses

b Progressive disease events were based on combined BICR and Investigator assessments due to very small number of events in BICR assessment.

The earliest reported date was used for a conservative estimate.

c SoC is the combination of the FOLFIRI/bev and FOLFOX/bev arms

d PFS HR is the comparison of the onvansertib arm to FOLFIRI/bev

e PFS HR is the comparison of the onvansertib arm to SoC

f Fisher’s exact test

g Log-rank test

Onvansertib in combination with chemo/bevacizumab was well-tolerated and to date there have been no major or unexpected toxicities observed.

The patients who remain on the CRDF-004 study are continuing to be monitored for efficacy as well as safety in the ongoing trial.

Other Clinical Programs:

Phase 1b/2 Investigator-Initiated Clinical Trial in First-Line mPDAC

In February 2024, the FDA approved NALIRIFOX as a first-line treatment option for mPDAC.

As a result, we are currently supporting a new investigator-initiated mPDAC Phase 1b/2 trial of onvansertib in combination with first-line SoC NALIRIFOX, which is now open for enrollment at the University of Kansas Medical Center.

The trial replaced a previously planned two-cohort, non-randomized Phase 2 trial of onvansertib in combination with first-line SoC Gemzar ® and Abraxane ® .

As a result, we are currently supporting an investigator-initiated mPDAC Phase 1b/2 trial of onvansertib in combination with first-line SoC NALIRIFOX, which is now open for enrollment at the University of Kansas Medical Center.

replaced a previously planned two-cohort, non-randomized Phase 2 trial of onvansertib in combination with first-line SoC Gemzar ® and Abraxane ® .

For more information, please visit NCT06736717 at www.clinicaltrials.gov.

The primary objective in this study is to determine anti-tumor activity by measuring Overall Response Rate (ORR).

The primary objective in this study is to determine anti-tumor activity by measuring ORR.

The secondary objectives are to determine treatment safety based on toxicities in participants who have received at least one dose of onvansertib, to determine anti-tumor activity by Progression Free Survival ("PFS"), to determine anti-tumor activity by Disease Control Rate ("DCR"), to determine Overall Survival ("OS").

Phase 2 Clinical Trial in mPDAC

CRDF-001, a Phase 2 open-label multi-center clinical trial of onvansertib in combination with nanoliposomal irinotecan (Onivyde ® ), leucovorin, and fluorouracil for 2 nd line treatment of patients with mPDAC, completed enrollment in October 2023.

The objective of this trial was to assess the safety and preliminary efficacy of onvansertib in combination with nanoliposomal irinotecan (Onyvide ® ), 5-FU and leucovorin as a 2 nd line treatment in patients with mPDAC who have failed first-line gemcitabine-based therapy.

For more information, please visit NCT04752696 at www.clinicialtrials.gov .

Preliminary data presented on September 26, 2023, and updated on February 29, 2024, showed promising data that caused us to shift the program to a first-line investigator initiated trial.

mPDAC biomarker discovery trial

The investigator-initiated biomarker discovery trial is exploring the impact of onvansertib 10-day monotherapy on tumors in mPDAC patients, and enrolled at the Oregon Health & Science University (OHSU) Knight Cancer Institute.

Enrollment for this trial is closed.

Preliminary data were presented on September 26, 2023.

One patient demonstrated an 86% decrease in Ki67, a well-established biomarker of tumor proliferation, and a 28% decrease in CA 19-9, a clinically-used biomarker to monitor treatment response.

Other Clinical Programs:

Phase 2 Investigator-Initiated Clinical Trial in SCLC

2 unchanged sentences

Stage 2 is designed to enroll an additional 20 patients.

The primary endpoint of the trial is ORR, while key secondary endpoints include PFS and overall survival.

The primary endpoint of the trial is ORR, while key secondary endpoints include PFS and OS.

For more information, please visit NCT05450965 at www.clinicialtrials.gov .

1 unchanged sentence

Preliminary efficacy data for seven patients presented on September 26, 2023, showed one confirmed partial response (“PR”), three stable disease (“SD”) and three progressive disease (“PD”).

The disease control rate (“DCR”), including PR and SD, is 57% (4 of 7 patients).

Phase 1b Investigator-Initiated Clinical Trial in TNBC

A single-arm, Phase 1b trial of onvansertib in combination with paclitaxel in patients with unresectable locally advanced or metastatic TNBC is open for enrollment at Dana Farber Cancer Institute ("DFCI").

In Phase 1b, approximately 14-16 patients will be treated with different doses of onvansertib in combination with a fixed dose of paclitaxel to determine the maximum tolerated dose and the safety and efficacy of onvansertib in combination with paclitaxel.

The DCR, including PR and SD, is 57% (4 of 7 patients).

Phase 1b Investigator-Initiated Clinical Trial in mTNBC

A single-arm, Phase 1b trial of onvansertib in combination with paclitaxel in patients with unresectable locally advanced or metastatic TNBC at Dana Farber Cancer Institute ("DFCI") has completed enrollment.

The trial was designed to treat approximately 14-16 patients with different doses of onvansertib in combination with a fixed dose of paclitaxel to determine the maximum tolerated dose and the safety and efficacy of onvansertib in combination with paclitaxel.

In June 2025, the investigator presented promising data from this trial at ASCO:

• Patients enrolled in the trial received a median of 3 prior lines of chemotherapy.

• Onvansertib in combination with paclitaxel demonstrated 40% objective response rate by RECIST 1.1 at RP2D of 18mg/m 2 (n=10), with two confirmed partial responses and two unconfirmed partial responses.

• The combination of onvansertib and paclitaxel was well-tolerated and demonstrated a safe and manageable toxicity profile with myelosuppression being the most common adverse event.

• Collectively, this clinical data further supports the potential exploration of the combination of onvansertib plus paclitaxel for the treatment of mTNBC.

For more information, please visit NCT05383196 at www.clinicialtrials.gov .

Phase 1 Investigator-Initiated Clinical Trial in CMML

This phase I trial is designed to evaluate the safety, effectiveness, and best dose of onvansertib for the treatment of patients with chronic myelomonocytic leukemia and Myelodysplastic syndrome/myeloproliferative neoplasm (MDS/MPN) overlap neoplasms that has come back (recurrent) or that does not respond to treatment (refractory).

Data presented at the American Society of Hematology (ASH) meeting on December 8, 2025, from this ongoing Phase 1 dose-escalation trial (N=9) showed that onvansertib monotherapy was generally well tolerated and demonstrated preliminary efficacy in approximately 40% of patients.

One patient achieved an optimal marrow response at the 9 mg/m² dose and three patients achieved clinical benefit at 6 mg/m2 and 12 mg/m2.

Dose expansion is currently open and recruiting at the 12 mg/m2 dose.

These findings, together with previously reported results from an investigator-sponsored trial in small cell lung cancer, support onvansertib’s single-agent activity across both hematologic and solid tumors.

Identifying Biomarkers that Predict Patient Benefit

6 unchanged sentences

We operate in one business segment, using one measurement of profitability to manage our business.

We do not assess the performance of geographic regions on measures of revenue or comprehensive income or expense.

We do not assess the performance of geographic regions on measures of revenue or comprehensive income (loss) or expense.

In addition, all of our principal operations, assets and decision-making functions are located in the U.S.

10 unchanged sentences

Additional Cancer Indications

We and certain investigators are currently conducting signal-finding clinical trials to explore the treatment opportunity for onvansertib in mPDAC, SCLC and TNBC.

We and certain investigators are currently conducting signal-finding clinical trials to explore the treatment opportunity for onvansertib in mPDAC, SCLC, TNBC and CMML.

Collaborative Relationship

1 unchanged sentence

In connection with the stock purchase, we and Pfizer entered into an Information Rights Agreement pursuant to which Pfizer had the right until May 17, 2024 to appoint an individual to our Scientific Advisory Board.

Currently Nicholas Choong,

MD, Vice President of Clinical Development and Therapeutic Area Head of GI cancers, Gynecologic cancers and Melanoma is Pfizer's designee to our Scientific Advisory Board.

In addition, until May 17, 2024 we agreed to provide Pfizer with rights of first access to any pre-clinical or final clinical data and results generated as part of the onvansertib development program at least two business days prior to us providing such data to a third party.

Currently Nicholas Choong, MD, Vice President of Clinical Development and Therapeutic Area Head of GI cancers, Gynecologic cancers and Melanoma is Pfizer's designee to our Scientific Advisory Board.

In addition, until May 17, 2024 we agreed to

provide Pfizer with rights of first access to any pre-clinical or final clinical data and results generated as part of the onvansertib development program at least two business days prior to us providing such data to a third party.

In August 2023, we announced that Pfizer Ignite, a new end-to-end service for biotech companies, will be responsible for the clinical activities of our new CRDF-004 trial in first-line RAS-mutated mCRC.

5 unchanged sentences

As of December 31, 2025, our owned and licensed intellectual property included 51 issued patents and 65 pending patent applications in the U.S.

and abroad, some of which are related to our legacy patent portfolio.

The pending patent applications include multiple international patent applications filed under the Patent Cooperation Treaty that may be used as the basis for multiple additional patent applications worldwide.

We licensed onvansertib from Nerviano Medical Sciences ("NMS" or "Nerviano") pursuant to a license agreement with NMS dated March 13, 2017 which grants us exclusive, worldwide rights under a portfolio of three patent families of U.S.

Our owned intellectual property includes twenty-five patent families relating to onvansertib.

One of the patent families includes U.S.

12,144,813 and 12,263,173 with an expected expiration date of no earlier than 2043.

The claims of these patents cover the method of using onvansertib in combination with bevacizumab (bev) for the treatment of KRAS mutated metastatic colorectal cancer (mCRC) patients who have not previously been treated with bev.

Additional families are directed to treating cancer using PLK1 inhibitors and determining efficacy of the treatment, treating benign prostatic hyperplasia using onvansertib, treating prostate cancer using PLK1 inhibitors, determining or predicting efficacies or responsiveness of PLK1 inhibitor treatments based on biomarkers, and treating cancers with combination therapies of PLK1 inhibitors (including combination therapies of PLK1 inhibitors with B-cell lymphoma 2 inhibitors, poly ADP ribose polymerase inhibitors, fibroblast growth factor receptor inhibitors, lysine-specific demethylase 1 inhibitors, irinotecan, MTDP inhibitors, anti-angiogenics, cell cycle inhibitors, phosphoinositide 3-kinase inhibitors, Akt (protein kinase B) inhibitors).

Any patents issued in these families will expire between 2039 and 2045.

Our intellectual property includes two patent families licensed from MIT.

On September 19, 2018, we entered into an Exclusive Patent License Agreement with MIT to a patent family directed to combination therapies including an antiandrogen or androgen antagonist and a polo-like kinase inhibitor (such as onvansertib) for the treatment of cancer.

The license agreement as amended covers the rights to develop combination therapies, expanding potential indications for onvansertib.

Under the agreement, we have exclusive rights to develop, make, use, and sell combination therapies that include a PLK inhibitor in combination with an anti-androgen or androgen antagonist, or in combination with a microtubule polymerization inhibitor, for the treatment of cancer.

The exclusive license agreement is part of our strategy to explore the efficacy of onvansertib in combination with an anti-androgen drug or a microtubule polymerization inhibitor in cancers including prostate, breast, pancreatic, lung and gastrointestinal.

The family relating to the combination of a PLK inhibitor and an anti-androgen or androgen antagonistincludes U.S.

9,566,280, 10,155,006, 10,772,898, and 12,115,171 which will expire in 2035.

9,566,280 encompasses using abiraterone in combination with onvansertib to treat cancer.

10,155,006, 10,772,898 and 12,115,171 broaden earlier issued U.S.

9,566,280, by expanding the use of onvansertib to encompass combination therapies with any anti-androgen and androgen antagonist drug, such as Zytiga®, Xtandi® and Erleada® for the treatment of cancer, including metastatic and non-metastatic castrate-resistant prostate cancer.

Our intellectual property includes three patent families licensed from Nerviano Medical Sciences ("NMS" or "Nerviano").

We licensed onvansertib from NMS pursuant to a license agreement dated March 13, 2017 which grants us exclusive, worldwide rights under a portfolio of three patent families of U.S.

and foreign patents covering three broad areas:

6 unchanged sentences

patents of this licensed patent portfolio will expire in 2030, with patent term extension up to 2035.

The license agreement as amended covers the rights to develop combination therapies and identified predictive clinical biomarkers across cancer types, expanding potential indications for onvansertib.

The exclusive license agreement is part of our strategy to explore the efficacy of onvansertib in combination with anti-androgen drugs in cancers including prostate, breast, pancreatic, lung and gastrointestinal.

The licensed MIT patent family includes U.S.

9,566,280, 10,155,006, 10,772,898, and 12,115,171 which will expire in 2035, with patent term extension up to 2040.

9,566,280 encompasses using abiraterone in combination with onvansertib to treat cancer.

10,155,006, 10,772,898 and 12,115,171 broaden earlier issued U.S.

9,566,280, by expanding the use of onvansertib to encompass combination therapies with any anti-androgen and androgen antagonist drug, such as Zytiga ® , Xtandi ® and Erleada ® for the treatment of cancer, including metastatic and non-metastatic castrate-resistant prostate cancer.

Our owned intellectual property includes twenty-eight patent families related to onvansertib.

These families include patent applications directed to treating cancer using PLK1 inhibitors and determining efficacy of the treatment, treating benign prostatic hyperplasia using onvansertib, treating prostate cancer using PLK1 inhibitors, determining or predicting efficacies or responsiveness of PLK1 inhibitor treatments based on biomarkers, and treating cancers with combination therapies of PLK1 inhibitors (including combination therapies of PLK1 inhibitors with B-cell lymphoma 2 inhibitors, poly ADP ribose polymerase inhibitors, fibroblast growth factor receptor

inhibitors, lysine-specific demethylase 1 inhibitors, irinotecan, MTDP inhibitors, or anti-agiogenics).

Any patents issued in these families will expire between 2039 and 2045.

One of the patent families includes U.S.

12,144,813 with an expected expiration date of no earlier than 2043.

The claims of the patent cover the method of using onvansertib in combination with bevacizumab (bev) for the treatment of KRAS mutated metastatic colorectal cancer (mCRC) patients who have not previously been treated with bev.

Another one of the patent families includes a patent application directed to selecting and treating cancers with combination therapies of PLK1 inhibitors.

MIT and we co-own this family.

On November 17, 2021, we amended the Exclusive Patent License Agreement with MIT to include this patent family.

On February 18, 2026, Nerviano sent us a written notice alleging that we are in material breach of the license agreement with respect to (i) alleged joint ownership of certain of our U.S.

12.144.813 and 12.263.173 (the “Cardiff Patents”) and (ii) the filing of a joint invention continuation patent application.

We are currently reviewing the notice and believe we have meritorious defenses to the allegations contained therein.

The referenced Cardiff Patents are based on the results of our TROV-054 study with claims that cover the method of using onvansertib in combination with bevacizumab for the treatment of metastatic colorectal cancer patients who have not previously been treated with bevacizumab.

We intend to vigorously defend our rights under the license agreement.

If we are unable to cure or successfully dispute the alleged breach, Nerviano may have the right to terminate the license agreement, which would have a material adverse effect on our business, financial condition, and results of operations.

Wherever possible, we seek to protect our inventions by filing U.S.

15 unchanged sentences

The FDC Act and other federal and state statutes and regulations govern the testing, manufacturing, safety, effectiveness, labeling, storage, record keeping, approval, advertising and promotion of our products.

As a result of these laws and regulations, product development and product approval processes are very expensive and time-consuming.

As a result of

these laws and regulations, product development and product approval processes are very expensive and time-consuming.

FDA Approval Process

28 unchanged sentences

Once the submission is accepted for filing, the FDA begins an in-depth review.

agreed to certain performance goals in the review of marketing applications.

The FDA has agreed to certain performance goals in the review of marketing applications.

Most such applications for non-priority drug products are reviewed within ten months.

19 unchanged sentences

Biologics may be marketed only for the approved indications and in accordance with the provisions of the approved labeling.

Changes to some of the conditions established in an approved application, including changes in indications, labeling, or manufacturing processes or facilities, require submission and FDA approval of a new BLA or BLA supplement, before the change can be implemented.

or BLA supplement, before the change can be implemented.

A BLA supplement for a new indication typically requires clinical data similar to that in the original application, and the FDA uses the same procedures and actions in reviewing BLA supplements as it does in reviewing BLAs.

3 unchanged sentences

In addition, quality control as well as product manufacturing, packaging, and labeling procedures must continue to conform to CGMPs after approval.

Manufacturers and certain of their subcontractors are required to register their establishments with the FDA and certain state agencies, and are subject to periodic unannounced inspections by the FDA during which the agency inspects manufacturing facilities

to assess compliance with CGMPs.

Accordingly, manufacturers must continue to expend time, money, and effort in the areas of production and quality control to maintain compliance with CGMPs.

13 unchanged sentences

In addition, a claim including items or services resulting from a violation of the federal Anti-Kickback Statute constitutes a false or fraudulent claim for purposes of the False Claims Act.

As a result of a modification made by the Fraud Enforcement and Recovery Act of 2009, a claim includes “any request or demand” for money or property presented to the U.S.

As a result of a modification made by the Fraud Enforcement and Recovery Act of 2009, a claim includes “any request or demand”

for money or property presented to the U.S.

In addition, manufacturers can be held liable under the False Claims Act even when they do not submit claims directly to government payors if they are deemed to “cause” the submission of false or fraudulent claims.

2 unchanged sentences

Other companies have been prosecuted for causing false claims to be submitted because of the company’s marketing of the product for unapproved, and thus non-reimbursable, uses.

laws that prohibit knowingly and willfully falsifying, concealing or covering up a material fact or making any materially false, fictitious or fraudulent statements or representations, or making or using any false writing or document knowing the same to contain any materially false, fictitious or fraudulent statement or entry in connection with the delivery of, or payment for, benefits, items or services.

The federal Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) which, among other things, imposes criminal liability for executing or attempting to execute a scheme to defraud any healthcare benefit program, including private third-party payors, knowingly and willfully embezzling or stealing from a healthcare benefit program, willfully obstructing a criminal investigation of a healthcare offense, and creates federal criminal laws that prohibit knowingly and willfully falsifying, concealing or covering up a material fact or making any materially false, fictitious or fraudulent statements or representations, or making or using any false writing or document knowing the same to contain any materially false, fictitious or fraudulent statement or entry in connection with the delivery of, or payment for, benefits, items or services.

HIPAA, as amended by the Health Information Technology and Clinical Health Act of 2009 (“HITECH”) and its implementing regulations, which impose certain requirements relating to the privacy, security, transmission and breach reporting of individually identifiable health information upon entities subject to the law, such as health plans, healthcare clearinghouses and healthcare providers and their respective business associates that perform services for them that involve individually identifiable health information.

33 unchanged sentences

imposes rebates under Medicare Part B and Medicare Part D to penalize price increases that outpace inflation (first due in 2023);

and replaces the Part D coverage gap discount program with a new discounting program (beginning in 2025).

and replaces the Part D coverage gap discount

program with a new discounting program (beginning in 2025).

The IRA permits the Secretary of the Department of Health and Human Services (“HHS”) to implement many of these provisions through guidance, as opposed to regulation, for the initial years.

1 unchanged sentence

Individual states in the United States have also become increasingly active in implementing regulations designed to control pharmaceutical product pricing, including price or patient reimbursement constraints, discounts, restrictions on certain product access and marketing cost disclosure and other transparency measures, and, in some cases, measures designed to encourage importation from other countries and bulk purchasing.

In addition, regional healthcare authorities and individual hospitals are increasingly using bidding procedures to determine which drugs

and suppliers will be included in their healthcare programs.

In addition, regional healthcare authorities and individual hospitals are increasingly using bidding procedures to determine which drugs and suppliers will be included in their healthcare programs.

Furthermore, there has been increased interest by third party payors and governmental authorities in reference pricing systems and publication of discounts and list prices.

24 unchanged sentences

The PLK inhibitor that reached the latest stage of clinical development (Phase 3), is volasertib, a pan-PLK inhibitor developed by Boehringer Ingelheim.

Boehringer Ingelheim was developing volasertib plus LDAC for the

treatment of AML which did not meet the primary endpoint of ORR (EHA 2016).

Boehringer Ingelheim was developing volasertib plus LDAC for the treatment of AML which did not meet the primary endpoint of ORR (EHA 2016).

The data showed an unfavorable overall survival trend with the safety profile of volasertib plus LDAC considered as the main reason.

5 unchanged sentences

Plogosertib has primary selectivity for PLK1 and secondary selectivity for PLK2 and PLK3.

Our most advanced onvansertib program is in RAS-mutated metastatic colorectal cancer (mCRC).

The competitive landscape in metastatic colorectal cancer (mCRC) includes approved and investigational therapies, including BMS’s KRAZATI® (adagrasib), which has received accelerated FDA approval for previously treated KRAS G12C-mutated locally advanced or mCRC, as well as ongoing clinical trials in mCRC sponsored by Amgen, Pfizer, BMS, and Summit Therapeutics evaluating targeted and immuno-oncology approaches focusing on KRAS G12C inhibitors, ID-1/VEGF and PD-L1/VEGF.

Human Capital

29 unchanged sentences

We have generated limited revenue from operations, and we expect to incur substantial net losses for the foreseeable future as we seek to further develop and commercialize onvansertib.

We cannot predict the extent of

these future net losses, or when we may attain profitability, if at all.

We cannot predict the extent of these future net losses, or when we may attain profitability, if at all.

If we are unable to generate significant revenue from onvansertib or attain profitability, we will not be able to sustain operations.

11 unchanged sentences

Failure to obtain additional capital at acceptable terms would result in a material and adverse impact on our operations.

Our product candidate, onvansertib, is in the early stages of clinical development and its commercial viability remains subject to current and future preclinical studies, clinical trials, regulatory approvals and the risks generally inherent in the development of a pharmaceutical product candidate.

Management has performed an analysis and concluded that there exists a substantial doubt about our ability to continue as a going concern, which may hinder our ability to obtain future financing on terms acceptable to us, if at all.

Our financial statements as of December 31, 2025 have been prepared under a going concern basis.

Management has performed an analysis and concluded that there exists a substantial doubt about our ability to continue as a going concern.

Separately, our independent registered public accounting firm included in its opinion for the year ended December 31, 2025 an explanatory paragraph referring to our recurring losses from operations and expressing substantial doubt in our ability to continue as a going concern without additional capital becoming available.

Our ability to continue as a going concern is dependent upon our ability to obtain additional equity or debt financing, obtain government grants or reduce expenditures.

Our financial statements as of December 31, 2025 did not include

any adjustments that might result from the outcome of this uncertainty.

The reaction of investors to the inclusion of a going concern statement in the accompanying financial statement, and our potential inability to continue as a going concern, in future years could materially adversely affect our share price and our ability to raise new capital or enter into strategic alliances.

Our product candidate, onvansertib, is in the early-mid stages of clinical development and its commercial viability remains subject to current and future preclinical studies, clinical trials, regulatory approvals and the risks generally inherent in the development of a pharmaceutical product candidate.

If we are unable to successfully advance or develop our product candidate, our business will be materially harmed.

50 unchanged sentences

By contrast, larger pharmaceutical and bio-pharmaceutical companies often have substantial staff with extensive experience in conducting clinical trials with multiple product candidates across multiple indications.

In addition, they may have greater financial resources to compete for the same clinical

investigators and patients that we are attempting to recruit for our clinical trials.

In addition, they may have greater financial resources to compete for the same clinical investigators and patients that we are attempting to recruit for our clinical trials.

If potential competitors are successful in completing drug development for their product candidates and obtain approval from the FDA, they could limit the demand for onvansertib.

22 unchanged sentences

• fines, civil penalties and criminal prosecutions.

Additionally, at any time we or our collaborators may voluntarily suspend or terminate the preclinical or clinical development of a product candidate, or withdraw any approved product from the market if we believe that it may pose an unacceptable safety risk to patients, or if the product candidate or approved product no longer meets

our business objectives.

The ability to develop or market a pharmaceutical product outside of the U.S.

8 unchanged sentences

In order to develop our product candidate, we need to retain or attract certain personnel, consultants or advisors with experience in drug development activities that include a number of disciplines, including research and development, clinical trials, medical matters, government regulation of pharmaceuticals, manufacturing, formulation and chemistry, business development, accounting, finance, regulatory affairs, human resources and information systems.

We are highly dependent upon our senior management and scientific staff, particularly Mark Erlander, our Chief Executive Officer (“CEO”).

We are highly dependent upon our senior management and scientific staff, particularly Mani Mohindru, our interim Chief Executive Officer (“CEO”).

The loss of services of Dr.

Erlander or one or more of our other members of senior management could delay or prevent the successful completion of our planned clinical trials or the commercialization of our product candidate.

Mohindru or one or more of our other members of senior management could delay or prevent the successful completion of our planned clinical trials or the commercialization of our product candidate.

Our success depends in part on our continued ability to attract, retain and motivate highly qualified management, clinical and scientific personnel and on our ability to develop and maintain important relationships with leading academic institutions, clinicians and scientists.

4 unchanged sentences

If we lose any key managers or employees, or are unable to attract and retain qualified key personnel, directors, advisors or consultants, the development of our product candidate could be delayed or terminated and our business may be harmed.

Dependence on Third-Party Consultants

We rely heavily on third-party consultants and advisors to support key aspects of our operations, including research and development, regulatory strategy, clinical trial management, manufacturing, quality assurance, and business development.

These consultants are not our employees and may have commitments to other organizations, which could limit their availability to us.

If we are unable to retain these consultants, replace them on commercially reasonable terms, or effectively manage their performance, our development programs, regulatory submissions, and overall business operations could be delayed or adversely affected.

In addition, we have limited control over the timing, quality, and outcomes of the services provided by third-party consultants, and any failure by such consultants to perform in accordance with applicable regulatory standards or contractual obligations could expose us to reputational harm, increased costs, or regulatory enforcement actions.

Clinical trials involve a lengthy and expensive process with an uncertain outcome, and results of earlier studies and trials may not be predictive of future trial results.

7 unchanged sentences

Product candidates in later stages of clinical trials may fail to show safety and efficacy sufficient to support intended use claims despite having progressed through initial clinical testing.

The data collected from clinical trials of our product

candidate may not be sufficient to support the filing of an NDA or to obtain regulatory approval in the United States or elsewhere.

The data collected from clinical trials of our product candidate may not be sufficient to support the filing of an NDA or to obtain regulatory approval in the United States or elsewhere.

Because of the uncertainties associated with drug development and regulatory approval, we cannot determine if or when we will have an approved product for commercialization or achieve sales or profits.

57 unchanged sentences

Satisfaction of these requirements typically takes several years and the time needed to satisfy them may vary substantially, based on the type, complexity and novelty of the pharmaceutical product.

We cannot predict if or when we will submit an NDA for approval for our product candidate currently under development.

We cannot predict if or when we will submit an NDA for approval for our product

candidate currently under development.

Any approvals we may obtain may not cover all of the clinical indications for which we are seeking approval or may contain significant limitations on the conditions of use.

9 unchanged sentences

We cannot assure you that clinical trials conducted in one country will be accepted by other countries or that an approval in one country or region will result in approval elsewhere.

Inadequate funding for the FDA, the SEC and other government agencies could hinder their ability to hire and retain key leadership and other personnel, prevent new products and services from being developed or commercialized in a timely manner or otherwise prevent those agencies from performing normal business functions on which the operation of our business may rely, which could negatively impact our business.

The ability of the FDA to review and approve new products can be affected by a variety of factors, including government budget and funding levels, ability to hire and retain key personnel and accept the payment of user fees and statutory, regulatory and policy changes.

Average review times at the agency have fluctuated in recent years as a result.

In addition, government funding of the FDA and other government agencies on which our operations may rely, including those that fund research and development activities, is subject to the political process, which is inherently fluid and unpredictable.

Disruptions at the FDA and other agencies may also slow the time necessary for new drugs to be reviewed and/or approved by necessary government agencies, which would adversely affect our business.

For example, over the last several years, the U.S.

government has shut down several times and certain regulatory agencies, such as the FDA and the SEC, have had to furlough critical employees and stop critical activities.

If a prolonged government shutdown occurs, or if global health concerns prevent the FDA or other regulatory authorities from conducting their regular 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 adverse effect on our business.

Further, in our operations as a public company, future government shutdowns could impact our ability to access the public markets and obtain necessary capital in order to properly capitalize and continue our operations.

If our product candidate is unable to compete effectively with marketed drugs targeting similar indications as our product candidate, our commercial opportunity will be reduced or eliminated.

We face competition generally from established pharmaceutical and biotechnology companies, as well as from academic institutions, government agencies and private and public research institutions.

Many of our competitors have significantly greater financial resources and expertise in research and development, manufacturing, preclinical testing, conducting clinical trials, obtaining regulatory approvals and marketing approved products than we do.

Many of our competitors have significantly greater financial resources and expertise in research and development, manufacturing, preclinical

testing, conducting clinical trials, obtaining regulatory approvals and marketing approved products than we do.

Small or early-stage companies may also prove to be significant competitors, particularly through collaborative arrangements with large, established companies.

26 unchanged sentences

Manufacturers of pharmaceutical products may encounter difficulties in production, particularly in scaling up production.

These problems include difficulties with production costs and yields, quality control, including stability of the product and quality assurance testing, shortages of qualified personnel, as well as compliance with federal, state and foreign regulations.

These problems include

difficulties with production costs and yields, quality control, including stability of the product and quality assurance testing, shortages of qualified personnel, as well as compliance with federal, state and foreign regulations.

In addition, any delay or interruption in the supply of clinical trial supplies could delay the completion of our clinical trials, increase the costs associated with conducting our clinical trials and, depending upon the period of delay, require us to commence new clinical trials at significant additional expense or to terminate a clinical trial.

22 unchanged sentences

If our manufacturers are unable to obtain these materials for our clinical trials, testing of the affected product candidate would be delayed, which may significantly impact our ability to develop the product candidate.

If we or our manufacturers are unable to purchase these materials after regulatory approval has been obtained for one of our products, the commercial launch of such product would be delayed or there would be a shortage in supply of such product, which would harm our ability to generate revenues from such product and achieve or sustain profitability.

be a shortage in supply of such product, which would harm our ability to generate revenues from such product and achieve or sustain profitability.

Our product candidate, if approved for sale, may not gain acceptance among physicians, patients, and the medical community, thereby limiting our potential to generate revenues.

44 unchanged sentences

Accordingly, in order to generate and expand our development pipeline, we have relied, and will continue to rely, on obtaining discoveries, new technologies, intellectual property and product candidates from third-parties through sponsored research, in-licensing arrangements or acquisitions.

We may face substantial competition from other biotechnology and pharmaceutical companies, many of which may have greater resources then we have, in obtaining these in-licensing, sponsored research or acquisition opportunities.

We may face substantial competition from other biotechnology and

pharmaceutical companies, many of which may have greater resources then we have, in obtaining these in-licensing, sponsored research or acquisition opportunities.

Additional in-licensing or acquisition opportunities may not be available to us on terms we find acceptable, if at all.

17 unchanged sentences

In addition, the Nerviano Agreement requires us to make certain payments, including license fees, milestone payments, royalties, and other such terms typically required under licensing agreements and these types of technology in-licenses generally could make it difficult for us to find corporate partners and less profitable for us to develop product candidates utilizing these existing product candidates and technologies.

On February 18, 2026, Nerviano sent us a written notice alleging that we are in material breach of the Nerviano Agreement with respect to (i) alleged joint ownership of certain of our patents and (ii) the filing of a joint invention continuation patent application.

We are currently evaluating the notice and intend to respond within the applicable cure period set forth in the Nerviano Agreement.

If we are unable to cure the alleged breach or successfully dispute the alleged breach within the applicable cure period, Nerviano may exercise its right to terminate the Nerviano Agreement.

Any such termination would result in the loss of our license rights to onvansertib and any other intellectual property licensed thereunder, which would have a material adverse effect on our business, financial condition, results of operations, and prospects.

We may delay or terminate the development of our product candidate at any time if we believe the perceived market or commercial opportunity does not justify further investment, which could materially harm our business.

Even though the results of preclinical studies and clinical trials that have been conducted or may conduct in the future may support further development of our product candidate, we may delay, suspend or terminate the future development of a product candidate at any time for strategic, business, financial or other reasons, including the determination or belief that the emerging profile of the product candidate is such that it may not receive FDA approval, gain meaningful market acceptance, generate a significant return to shareholders, or otherwise provide any competitive advantages in its intended indication or market.

determination or belief that the emerging profile of the product candidate is such that it may not receive FDA approval, gain meaningful market acceptance, generate a significant return to shareholders, or otherwise provide any competitive advantages in its intended indication or market.

We will need to increase the size of our organization, and we may experience difficulties in managing growth.

23 unchanged sentences

It is essential to our business strategy that our technology and network infrastructure and our physical buildings remain secure and are perceived by our customers and corporate partners to be secure.

Despite security measures, however, any network infrastructure may be vulnerable to cyber-attacks by hackers and other security threats.

Despite security measures, however, any network infrastructure may be vulnerable to cyber-attacks by hackers and other security

We may face cyber-attacks that attempt to penetrate our network security, sabotage or otherwise disable our research, products and services, misappropriate our or our partners’ and third party providers proprietary information, which may include personally identifiable information, or cause interruptions of our internal systems and services.

51 unchanged sentences

There have been several Congressional inquiries and proposed bills designed to, among other things, bring more transparency to product pricing, review the relationship between pricing and manufacturer patient programs, and reform government program reimbursement methodologies for drug products.

Most recently, on August 16, 2022, the Inflation Reduction Act of 2022 (IRA) was signed into law.

On August 16, 2022, the Inflation Reduction Act of 2022 (IRA) was signed into law.

Among other things, the IRA requires manufacturers of certain drugs to engage in price negotiations with Medicare (beginning in 2026), with prices that can be negotiated subject to a cap;

3 unchanged sentences

For that and other reasons, it is currently unclear how the IRA will be effectuated.

Additionally, in April 2025, an executive order was signed directing the Secretary of HHS to take appropriate steps to, among other things, modify certain provisions of the Medicare Drug Price Negotiation Program, develop and implement a payment model to reduce the price of high-cost prescription drugs and biological products covered by Medicare, accelerate approval of generic and biosimilar products, and facilitate the ability of states to import pharmaceuticals from other countries, and in May 2025, an executive order was signed, among other things, directing the Secretary of HHS to propose rules that impose “most-favored-nation” pricing and take other measures to reduce the cost of prescription drugs.

currently unclear whether and to what extent these measures will be implemented and what impact any such implementation would have on our business.

Further, there can be no assurance that the current administration or future administrations will not pursue different or additional measures, such as those intended to more closely align U.S.

drug prices with international drug prices (often referred to as “reference” or “international price index” drug pricing).

Future price controls or other changes in pricing regulation or negative publicity related to the pricing of pharmaceutical drugs could restrict the amount that we are able to charge for our product candidates, which could render our product candidates, if approved, commercially unviable and materially adversely affect our ability to raise additional capital on acceptable terms.

15 unchanged sentences

Geopolitical risks associated with Russia’s invasion of Ukraine could result in increased market volatility and uncertainty, which could negatively impact our business, financial condition, and results of operations.

The uncertain nature, scope, magnitude, and duration of hostilities stemming from Russia’s military invasion of Ukraine, including the potential effects of such hostilities as well as sanctions, embargoes, asset freezes, cyber-attacks and other actions taken in response to such hostilities on the world economy and markets, have disrupted global markets and contributed to increased market volatility and uncertainty, which could have an adverse impact on macroeconomic and other factors that affect our business and supply chain.

cyber-attacks and other actions taken in response to such hostilities on the world economy and markets, have disrupted global markets and contributed to increased market volatility and uncertainty, which could have an adverse impact on macroeconomic and other factors that affect our business and supply chain.

There can be no certainty regarding the impacts stemming from the invasion, including the imposition of additional sanctions, embargoes, asset freezes or other economic or military measures resulting from the invasion.

22 unchanged sentences

In addition to our patents, we rely on contractual restrictions to protect our proprietary technology.

We require our employees and third parties to sign confidentiality agreements and our employees are also required to sign agreements assigning to us all intellectual property arising from their work for us.

We require our employees and third parties to sign confidentiality agreements and our employees are also required to sign

agreements assigning to us all intellectual property arising from their work for us.

Nevertheless, we cannot guarantee that these measures will be effective in protecting our intellectual property rights.

30 unchanged sentences

An adverse determination may subject us to significant liabilities or require us to seek licenses that may not be available from third parties on commercially favorable terms, if at all.

Further, if such claims are proven valid, through litigation or otherwise, we may be required to pay substantial monetary damages, which can be tripled if the infringement is deemed willful, or be required to discontinue or significantly delay development, marketing, selling and licensing of the affected products and intellectual property rights.

Further, if such claims are proven valid, through litigation or otherwise, we may be required to pay substantial monetary damages, which can be tripled if the

infringement is deemed willful, or be required to discontinue or significantly delay development, marketing, selling and licensing of the affected products and intellectual property rights.

Our competitors may have filed, and may in the future file, patent applications covering technology similar to ours.

22 unchanged sentences

An ownership change can therefore result in significantly greater tax liabilities than a corporation would incur in the absence of such a change and any increased liabilities could adversely affect the corporation’s business, results of operations, financial condition and cash flow.

federal income tax reform could adversely affect us.

On December 22, 2017, President Trump signed into law the TCJA that significantly reforms the Internal Revenue Code of 1986, as amended.

The TCJA, among other things, includes changes to U.S.

federal tax rates, imposes significant additional limitations on the deductibility of interest, allows for the expensing of capital expenditures, and puts into effect the migration from a “worldwide” system of taxation to a territorial system.

We do not expect tax reform to have a material impact to our projection of minimal cash taxes or to our net operating losses.

Further, any eligibility we may have or may someday have for tax credits associated with the qualified clinical testing expenses arising out of the development of orphan drugs will be reduced to 25% as a result of the TCJA;

thus, our net future taxable income may be affected.

We continue to examine the impact this tax reform legislation may have on our business.

The impact of this tax reform on holders of our common stock is uncertain and could be adverse.

Uncertainties in the interpretation and application of existing, new and proposed tax laws and regulations could materially affect our tax obligations and effective tax rate.

The tax regimes to which we are subject or under which we operate are unsettled and may be subject to significant change.

The issuance of additional guidance related to existing or future tax laws, or changes to tax laws or regulations proposed or implemented by the current or a future U.S.

presidential administration, Congress, or taxing authorities in other jurisdictions, including jurisdictions outside of the United States, could materially affect our tax obligations and effective tax rate.

To the extent that such changes have a negative impact on us, including as a result of related uncertainty, these changes may adversely impact our business, financial condition, results of operations, and cash flows.

In July 2025, the OBBBA was signed into law, and it (along with other recent U.S.

federal tax reform) has resulted in significant changes to the taxation of business entities including, among other changes, changes to the taxation of income derived from international operations, changes in the deduction and amortization of research and development expenditures, and limitations on the deductibility of business interest.

Future guidance from the Internal Revenue Service and other tax authorities with respect to any legislation may affect us, and certain aspects of such legislation could be repealed or modified or sunset in future years.

The rights of the holders of our common stock may be impaired by the potential issuance of preferred stock.

96 unchanged sentences

We require that our subcontractors report cybersecurity incidents to our IT Incident Response Coordinator who will investigate the direct impact of the incident.

Once a potential incident has been confirmed, the Incident Response Coordinator will notify senior management that activation of the incident response plan is required and assign a severity rating, ranging from none to critical, based on the perceived impact.

Once a potential incident has been confirmed, the Incident Response Coordinator will notify senior

management that activation of the incident response plan is required and assign a severity rating, ranging from none to critical, based on the perceived impact.

The Audit Committee has oversight responsibility for risks and incidents relating to cybersecurity threats, including compliance with disclosure requirements, cooperation with law enforcement, and related effects on financial and other risks , and it reports any findings and recommendations, as appropriate, to the full Board for consideration.

1 unchanged sentence

Our Information Technology Lead is responsible for the strategic leadership and day-to-day management of our cybersecurity risk management program.

The individual is working in that role for more than 10 years for the company.

This individual has been working in that role for more than 10 years for the company.

We also engaged with third-party IT service providers, who specialize in the field of cybersecurity risk management, for targeted employee training and system risk assessments.

6 unchanged sentences

LEGA L PROCEEDINGS

From time to time, we may become involved in various lawsuits and legal proceedings that arise in the ordinary course of business.

Litigation is subject to inherent uncertainties, and an adverse result in matters may arise from time to time that may harm our business.

As of the date of this report, management believes that there are no claims against us, which it believes will result in a material adverse effect on our business or financial condition.

The information called for by this item is incorporated herein by reference to the information set forth in "Note 9.

Commitments and Contingencies” in the Notes to Consolidated Financial Statements included in Item 8 of this Report.

MI NE SAFETY DISCLOSURES

1 unchanged sentence

Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 1. Business