AI Terminal

MODULE: AI_ANALYST
Interactive Q&A, Risk Assessment, Summarization
MODULE: DATA_EXTRACT
Excel Export, XBRL Parsing, Table Digitization
MODULE: PEER_COMP
Sector Benchmarking, Sentiment Analysis
SYSTEM ACCESS LOCKED
Authenticate / Register Log In

RYVU Therapeutics S.A.

Quarterly Report Nov 20, 2025

5798_rns_2025-11-20_e3730ff0-0565-4292-9b30-4a2f0694c039.pdf

Quarterly Report

Open in Viewer

Opens in native device viewer

RYVU THERAPEUTICS S.A. Q3 2025 Report

TABLE OF CONTENTS

1. ECONOMIC AND FINANCIAL HIGHLIGHTS 2
1.1.
Financial Results Obtained in the Reporting Period 2
1.2.
Management Board comments to the financial results 4
1.3.
The Company's Assets and the Structure of Assets and Liabilities 6
1.4.
Current and Projected Financial Condition 7
2. MANAGEMENT BOARD INFORMATION ON ACTIVITIES 8
2.1.
The Pipeline 8
2.2.
Significant events in Q1- Q3 2025 14
2.3. Unusual events occurring in the reporting period 26
3. THE ISSUER'S CORPORATE BODIES 27
4. INFORMATION ON THE SHAREHOLDERS HOLDING (DIRECTLY OR INDIRECTLY) AT LEAST 5% OF THE
TOTAL NUMBER OF VOTES AT THE GENERAL SHAREHOLDERS' MEETING OF THE COMPANY AND ON
SHARES HELD BY MEMBERS OF THE ISSUER'S MANAGEMENT BOARD AND SUPERVISORY BOARD 28
5. STATEMENT OF THE MANAGEMENT BOARD REGARDING APPLICABLE ACCOUNTING PRINCIPLES . 30
6. ADDITIONAL INFORMATION 31

1. ECONOMIC AND FINANCIAL HIGHLIGHTS

1.1. Financial Results Obtained in the Reporting Period

Condensed Interim Financial Statements of Ryvu Therapeutics S.A. ("Company", "Issuer", "Ryvu") for the period from January 1, 2025 to September 30, 2025 are prepared in accordance with the requirements of the International Accounting Standard No. 34 "Interim Financial Reporting" endorsed by the EU ("IAS 34").

Selected data of the statement of financial position are as follows:

Ryvu Therapeutics S.A. Data a in PLN thousand Data in EUR thousand
Item 30.09.2025 31.12.2024
restated
30.09.2025 31.12.2024
restated
Total assets 255,338 378,777 59,809 88,644
Short-term receivables 18,212 35,776 4,266 8,373
Cash and cash equivalents 89,122 160,073 20,876 37,462
Other current and non-current financial assets 47,436 65,876 11,111 15,417
Total liabilities 184,115 226,484 43,126 53,004
Long-term liabilities 112,440 118,556 26,338 27,745
Short-term liabilities 71,674 107,928 16,789 25,258
Total equity 71,223 152,293 16,683 35,641
Share capital 9,248 9,248 2,166 2,164

Selected data of statement of comprehensive income are as follows:

Ryvu Therapeutics S.A. Data in PLN thousand Data in EUR thousand
Item From 01.01.2025
to 30.09.2025
From 01.01.2024
to 30.09.2024
From 01.07.2025
to 30.09.2025
From 01.07.2024
to 30.09.2024
From 01.01.2025
to 30.09.2025
From 01.01.2024
to 30.09.2024
From 01.07.2025
to 30.09.2025
From 01.07.2024
to 30.09.2024
Revenues from sales 34,357 33,954 11,445 11,559 8,110 7,892 2,682 2,698
Revenues from subsidies 17,667 21,049 4,577 9,959 4,170 4,893 1,072 2,324
Revenues from R&D projects 9,897 18,469 3,473 3,513 2,336 4,293 814 820
Other operating revenues 11 83 6 2 3 19 1 1
Revenues from operating activities 61,932 73,555 19,500 25,032 14,619 17,097 4,569 5,842
Operating expenses -152,691 -155,135 -44,896 -51,360 -36,042 -36,060 -10,519 -11,987
Operating expenses without Incentive Scheme and valuation of
Nodthera shares
-139,777 -151,215 -44,235 -49,512 -32,994 -35,148 -10,365 -11,555
Depreciation -7,576 -7,973 -2,858 -2,503 -1,788 -1,853 -670 -584
Valuation of Incentive Scheme -2,570 -2,951 -687 -710 -607 -686 -161 -166
Loss from operating activities (EBIT) -90,760 -81,580 -25,396 -26,327 -21,423 -18,962 -5,950 -6,144
Loss from operating activities (EBIT) without Incentive Scheme and
valuation of Nodthera shares
-77,845 -77,659 -24,735 -24,478 -18,375 -18,051 -5,796 -5,713
Loss before income tax -83,623 -76,242 -24,707 -26,552 -19,739 -17,722 -5,789 -6,197
Net loss -83,640 -76,383 -24,707 -26,565 -19,743 -17,755 -5,789 -6,200
Net loss without Incentive Scheme -81,071 -73,433 -24,019 -25,856 -19,136 -17,069 -5,628 -6,034
EBITDA -83,184 -73,607 -22,538 -23,824 -19,635 -17,109 -5,281 -5,560
EBITDA without Incentive Scheme and valuation of Nodthera shares -70,269 -69,686 -21,877 -21,975 -16,587 -16,198 -5,126 -5,129
Net cash flows from operating activities -86,008 -101,544 -17 417 -36,256 -20,302 -23,603 -4,081 -8,462
Net cash flows from investing activities 18,172 128,022 -13 75,507 4,289 29,758 3 17,856
Net cash flows from financing activities -2,784 92,044 -614 23,590 -657 21,395 -144 5,506
Total net cash flow -70,620 118,522 -18,044 63,841 -16,669 27,549 -4,228 14,900
Number of shares (weighted average) 23,120,148 23,120,148 23,120,148 23,120,148 23,120,148 23,120,148 23,120,148 23,120,148
Profit (loss) per share (in PLN) -3.62 -3.30 -1.07 -1.15 -0.85 -0.77 -0.25 -0.27
Diluted profit (loss) per share (in PLN) -3.62 -3.30 -1.07 -1.15 -0.85 -0.77 -0.25 -0.27
Book value per share (in PLN) 3.08 8.05 3.08 8.05 0.72 1.88 0.72 1.88
Diluted book value per share (in PLN) 3.08 8.05 3.08 8.05 0.72 1.88 0.72 1.88

Selected financial data presented in the quarterly report were converted to Euro as follows:

    1. Items relating to the profit and loss statement and the cash flow statement were converted using the exchange rate constituting the arithmetic average of the exchange rates, applicable as of the last day of every month in the given period, based on the information published by the National Bank of Poland (NBP):
  • for the period from 01/01/2025 30/09/2025: PLN 4.2365;
  • for the period from 01/01/2024 30/09/2024: PLN 4.3022;
    1. Balance sheet items were converted using the average exchange rate announced by the NBP applicable as of the balance sheet date; which were:

as of 30 September 2025: PLN 4.2692; as of 31 December 2024: PLN 4.2791.

1.2. Management Board comments to the financial results

In the first three quarters of 2025, Ryvu Therapeutics S.A. recognized total operating revenue of PLN 61,932 thousand, which constitutes a decrease compared to the corresponding period in 2024, when total operating revenue amounted to PLN 73,555 thousand. This results from a decrease in revenues from R&D projects (a decrease of PLN 8,573 thousand) and a decrease in revenues from subsidies (a decrease of PLN 3,382 thousand) partially compensated by an increase in revenues from sales (an increase of PLN 403 thousand) compared to the corresponding period in 2024.

The lower revenues from R&D projects in the first three quarters of 2025 were were primarily due to the recognition of a USD 2 million milestone payment under the exclusive license agreement with Exelixis Inc. in the first three quarters of 2024.

The increase in sales revenues resulted from collaboration with Berlin-Chemie AG (Menarini Group). Under the Agreement, Ryvu assumed responsibility from Menarini for conducting the Phase II clinical trial MEN1703 in relapsed/refractory DLBCL, which Menarini had previously implemented. The increase in sales revenue was partially offset by lower revenue from cooperation with BioNTech due to BioNTech's decision to exercise its right to terminate the STING program covering Ryvu's STING agonist portfolio as standalone small molecules (RVU312) along with two other of several previously undisclosed programs.

In the first nine months of 2025, Ryvu reported a net loss, as well as an operating loss. The net and operating losses result from the fact that the Company focuses on increasing the value of the ongoing projects that will be commercialized at a later stage of development.

The Company's net loss for the period ended September 30, 2025, amounted to PLN 83,640 thousand compared to the net loss of PLN 76,383 thousand in the corresponding period of 2024. The higher loss in first three quarters of 2025 in comparison to corresponding period in 2024, is related to lower operating revenues (described above) and higher negative impact in NodThera shares valuation of PLN 10,345 thousand (described below), partially compensated by positive impact of the put option issued by the Company to European Investment Bank to repurchase its equity instruments (described below). As a result of the cost discipline and the strategic reorganization announced in February 2025, the

Company's operating loss in Q3 2025 decreased by PLN 931 thousand compared to the corresponding period of 2024.

Valuation of shares in NodThera Inc.

Valuation of shares

The Company holds shares in NodThera Inc., a biotechnology company developing NALP3 inhibitors for the treatment of inflammatory and neuroinflammatory diseases.

As of September 30, 2025, four types of shares existed in NodThera Inc.: ordinary stock and preferred stock (Junior Preferred Stock, Series A1 and A2 Preferred Stock, Series B Preferred Stock, and Series C Preferred Stock). Ryvu is the holder of the Junior Preferred Stock.

On April 4, 2025, the Series D Preferred Stock was issued. The issuance included:

  • 12,666,663 Series D1 shares at a price of USD 1.50 per share,
  • 41,050,852 Series D2 shares at a price of USD 0.75 per share,
  • 30,048,510 Series D3 shares (constituting a conversion of debt financing) at a price of USD 0.7407 per share.

As a result, the issuance generated total funding of USD 49,788,133.50 (from Series D1 and D2) for NodThera Inc. The offering was limited to existing investors only. Series D shares carry the same preferential rights as Series A, B, and C shares. Ryvu did not participate in this issuance.

Therefore, the valuation was based on a share price of USD 0.9269 per share, which represents the weighted average price of Series D1 and D2 shares from the most recent financing round on April 4, 2025.

As of September 30, 2025, Ryvu held 1.2% shares in NodThera. Following the Series D issuance, Ryvu's shareholding decreased to 1.2%, and the total valuation of its stake amounts to PLN 6,429,131 (based on the NBP's average exchange rate of 3.6315 PLN/USD).

Valuation of shares in NodThera Inc. according to fair value:

New share issue price (in USD) 0.9269
Average NBP exchange rate from September 30, 2025 3.6315
New share issue price (in PLN) 3.3660
Number of the Company's shares in NodThera Inc. 1,910,000
Value of shares in the balance sheet as of September 30, 2025 6,429,131
Value of shares in the balance sheet as of December 31, 2024 16,773,742
Change in valuation – gross impact on the valuation of shares -10,344,611

Financing from the European Investment Bank

On August 16, 2022, the Company concluded a financing agreement with the European Investment Bank ("EIB"). Under the agreement, the EIB agreed to grant the Company a loan in the maximum amount of EUR 22,000,000. The purpose of the agreement is to support the development of the romaciclib (RVU120). The majority of the funding is allocated to cover expenses related to clinical trials, necessary regulatory approval activities, internal research and development for drug discovery, and costs associated with intellectual property protection.

The financing was paid in three tranches: Tranche A and Tranche B, each in the amount of EUR 8,000,000, and Tranche C, in the amount of EUR 6,000,000. The Company is obliged to repay each of the paid tranches in one installment, 5 years after its launch. The interest rate for Tranche A is 3% per annum, for Tranche B 2.7% per annum, and for Tranche C 2.4% per annum.

Additional consideration for Tranche A, Tranche B and Tranche C, are subscription warrants corresponding in total to 2.5% of the fully issued share capital of the Company. The validity period of the Warrants is 10 years, and EIB will have the right to exercise the Warrants upon the maturity of Tranche or a voluntary or mandatory prepayment event. Under the Warrant Agreement, the Company committed to issue 592,825 subscription warrants to the EIB, entitling the holder to acquire a total of 592,825 shares in the Company with a total nominal value of PLN 237,130.

Additionally, put option issued by the Company creates a contractual obligation to repurchase its equity instruments (warrants). On each reporting date after the initial recognition, the Company updates the amount of the liability for the put option, taking into account changes in the settlement price of this option, with the effects of the valuation reflected in the statement of comprehensive income. As of September 30, 2025, Ryvu recognized a positive impact of the put option in the amount of PLN 9,311 thousand.

1.3. The Company's Assets and the Structure of Assets and Liabilities

As of September 30, 2025, the value of the Company's assets was PLN 255,338 thousand and decreased by PLN 123,439 thousand compared to the end of 2024 (PLN 378,777 thousand), mainly due to expenditures on R&D projects. At the end of September 2025, the highest value of assets was cash, which amounted to PLN 89,122 thousand (at the end of 2024, it was PLN 160,073 thousand) and other financial assets of PLN 47,436 thousand (at the end of 2024, it was PLN 65,876 thousand). Fixed assets are mainly the Research and Development Centre for Innovative Drugs (named 'CBR') and laboratory equipment, as well as the valuation of NodThera shares of PLN 6,429 thousand.

Ryvu's equity amounted to PLN 71,223 thousand as of September 30, 2025 and decreased by PLN 81,070 thousand compared to December 31, 2024. The decrease in equity is primarily attributable to the net loss recorded for the period. The other source of asset funding are long-term liabilities, which amounted to PLN 112,440 thousand at the end of September 2025. The long-term liabilities are mainly related to the loan received from the European Investment Bank. Additionally, long-term liabilities include deferred income, largely related to deferred revenue from the BioNTech agreement and the infrastructure subsidy for CBR.

The asset structure demonstrates the Company's high financial liquidity, which is confirmed by the following ratios:

30.09.2025 31.12.2024
Current ratio
current assets/current liabilities including short
term provisions and accruals (excl. deferred
revenues)
2.36 2.67
Quick ratio
(current assets-inventory)/current liabilities
including short-term provisions and accruals (excl.
deferred revenues)
2.35 2,66

Cash surpluses not used in operating activities are deposited in low-risk financial instruments like short—and long-term bank deposits and investment funds.

1.4. Current and Projected Financial Condition

The Company's financial position as of the report date is strong, considering its current cash position and the financing received from the European Investment Bank. As of September 30, 2025, the value of the Company's cash amounted to PLN 136,554 thousand (PLN 89,164 thousand in cash at the banks and PLN 47,390 thousand in investment funds), and as of November 11, 2025, it was PLN 119,606 thousand (PLN 71,949 thousand in cash at the banks and PLN 47,657 thousand in investment funds). The decrease in cash resulted from expenditure incurred on early pipeline and clinical development projects.

The Company meets its obligations in a timely manner and maintains sustainable cash levels, ensuring its financial liquidity. Cash inflow from previous share issues, funds obtained from EU subsidies, financing received from the EIB, funds supporting R&D projects, and cash generated from the commercialization of projects enable the Company to execute its planned investments, particularly the development of ongoing and new innovative projects and the expansion of laboratory infrastructure. The Company's future revenues will strongly depend on the ability to commercialize its R&D projects.

2. MANAGEMENT BOARD INFORMATION ON ACTIVITIES

2.1. The Pipeline

Ryvu Therapeutics is advancing a broad pipeline addressing emerging targets in oncology.

Ryvu's pipeline includes candidates with differentiated therapeutic mechanisms, including programs directed at kinases, synthetic lethality, immuno-oncology and immunometabolism pathways. These research and development projects are represented below.

Source: Company's own data.

Romaciclib (RVU120)

Romaciclib (RVU120) is a clinical-stage, selective, first-in-class dual inhibitor of CDK8 and CDK19 kinases. The international nonproprietary name of romaciclib was assigned to RVU120 by the WHO and announced on the proposed list in February 2025, followed by the publication of the INN Recommended List 94 on 03 November, 2025. Romaciclib has demonstrated efficacy in several solid tumors and hematologic malignancies in in vitro and in vivo models. CDK8 and its paralog, CDK19, are kinase submodules of the mediator complex, involved in both transcriptional activation and repression, playing central roles in maintaining the viability of cancer cells and their undifferentiated state across various tumor types (Dannappel et al., 2019; Rzymski et al., 2015; Philip et al., 2018). CDK8/19 mediator complex integrates basal transcriptional machinery with the activity of oncogenic transcriptional and epigenetic factors. Inhibition of CDK8/19 can repress key oncogenic transcriptional programs and induce lineage commitment genes in acute myeloid leukemia (AML).

Romaciclib was internally discovered by Ryvu and has received support from the Leukemia & Lymphoma Society Therapy Acceleration Program® (TAP), a strategic initiative to partner directly with innovative biotechnology companies and leading research institutions to accelerate the development of promising new therapies for blood cancers.

On March 25, 2020, the U.S. Food and Drug Administration (FDA) granted romaciclib an orphan drug designation (ODD) for the treatment of patients with AML.

Two clinical Phase I studies with romaciclib are ongoing: (i) Phase Ib in patients with AML/HR-MDS (NCT04021368; CLI120-001, RIVER-51) and (ii) Phase I/II in patients with relapsed/refractory metastatic or advanced solid tumors (NCT05052255; RVU120-SOL-021, AMNYS-51). Enrollment is completed in both studies and all patients have discontinued study treatment.

Based on the available translational and clinical data, Ryvu initiated a Clinical Development Plan (CDP) for romaciclib, which includes four Phase II studies: RIVER-81, POTAMI-61, RIVER-52, and REMARK. Ryvu's focus of romaciclib CDP is on hematologic malignancies. Translational research is ongoing to determine the opportunities for romaciclib in solid tumors, and an investigator-initiated Phase I study to evaluate romaciclib in combination with everolimus in pediatric patients with medulloblastoma was announced in September 2025. The MEDWAY project will be executed by the Children's Memorial Health Institute (IPCZD) as a sponsor of the study under an approx. PLN 40 million grant awarded by the Medical Research Agency.

RIVER-81 Phase II study

On January 31, 2024, Ryvu announced the dosing of the first patient in the RIVER-81 Phase II study of romaciclib in combination with venetoclax (NCT06191263). RIVER-81 is a multicenter, open-label clinical trial that aims to assess the safety, tolerability, efficacy, pharmacokinetics (PK), and pharmacodynamics (PD) of romaciclib when administered in combination with venetoclax to patients with AML who are relapsed or refractory to prior therapy with venetoclax and a hypomethylating agent.

During the European Hematology Association (EHA) meeting in June 2025, in Milan, a data update was provided. As of May 14, 43 patients had been treated across various dose levels. After an initial expansion of 250 mg romaciclib administered every other day in combination with 400 mg venetoclax in a 2-week on 1-week off schedule (Part 2), dose optimization included another cohort of 150 mg romaciclib administered every day in combination with 400 mg venetoclax in a 2-week on 1-week off schedule (Cohort 4). In Part 2, 19 patients were treated, and 13 were evaluable for response at the time of data cut-off. Out of those, 3 achieved a CRx (23%, 2 CRi, 1 CRh). In Cohort 4, 7 patients were treated, and 6 patients were evaluable for response. The CR rate in the efficacy evaluable population was 50% (3/6, 2 CRi, 1 CR). All 3 patients were ongoing at the time of data presentation.

In an additional presentation for the same conference, translational data were presented to further support the scientific rationale of the RIVER-81 study. It could be demonstrated that romaciclib, in combination with venetoclax, has a strong capacity to overcome resistance to venetoclax. The underlying mechanism involves the downregulation of key resistance pathways, including the IL-6/JAK/STAT3, TGF-β, PI3K/AKT/mTOR, and inflammatory signaling pathways.

On November 3rd, Ryvu announced the acceptance of a poster presentation of updated results of the RIVER-81 study at the American Society of Hematology (ASH) Annual Meeting and Exposition in December 2025. The poster will include the most recent data. At the time of abstract submission in July 2025, Cohort 6 was ongoing, and in 2 evaluable patients, one achieved a CRi, and the other one achieved a substantial reduction of blasts.

The planned overall enrollment for RIVER-81 is approximately 98 patients. The execution of the RIVER-81 study is supported by a PLN 62.3 million grant from the Polish Medical Research Agency (ABM).

POTAMI-61 Phase II study

The Phase II POTAMI-61 study investigates romaciclib as both a monotherapy and a combination therapy for treating patients with myelofibrosis (MF). In Part A, Cohort 1 assesses romaciclib as a monotherapy in patients who have been previously treated with or are ineligible for treatment with a JAK inhibitor, and Cohort 2 assesses romaciclib in combination with ruxolitinib in patients experiencing a suboptimal response to JAK inhibitor therapy. Depending on results from Part A, cohorts 1 and/or 2 could be expanded in Part B, which will further assess safety, tolerability, and antitumor activity in a larger cohort, totaling up to approximately 230 patients for both Part A and Part B combined.

Romaciclib's potential in myelofibrosis is supported by its effect on bone marrow and hematopoietic cells observed in the clinical trial setting, as well as in translational data generated with Prof. Rajit Rampal at the Memorial Sloan Kettering Cancer Centre as part of a collaboration with Ryvu established in 2021. It was demonstrated that romaciclib successfully attenuates myelofibrosis phenotypes when used as a single agent or in combination with ruxolitinib in murine models of myelofibrosis, furthermore, romaciclib was shown to act synergistically with a whole class of JAK inhibitors and the BET inhibitor pelabresib.

The POTAMI-61 study was launched at clinical sites in Poland and Italy, and on December 5, 2024, the first patient received treatment.

An update of early study data was presented at the EHA Congress in June 2025. As of May 14, 21 patients had been treated across both cohorts. There were no new safety findings, and romaciclib, when used as a single agent or in combination with ruxolitinib, was tolerated by patients with MF. While the primary endpoint of spleen size reduction will be assessed after 24 weeks of treatment, the first response assessment is performed after 12 weeks of treatment. At the time of data cutoff, 8 patients (3 in Cohort 1 and 5 in Cohort 2) had undergone an assessment of spleen size. Four of these patients (2 in Cohort 1, 2 in Cohort 2) had a spleen size reduction of more than 10%. Data to assess the impact on the total symptom score, which is a secondary endpoint, was available in 4 patients (1 in Cohort 1, 3 in Cohort 2). One patient in Cohort 2 exceeded the 50% reduction, and another patient in Cohort 1 had a reduction of more than 45%. Notably, in one patient with a spleen size reduction of more than 35%, a reduction of the grade of bone marrow fibrosis was detected after 12 weeks of treatment.

The study is ongoing, and on November 3rd, Ryvu announced the acceptance of a poster presentation of updated results of the POTAMI-61 study at the ASH Annual Meeting and Exposition in December 2025. The poster will include the most recent data. At the time of abstract submission in July 2025, four patients had reached the 24-week assessment time point. One patient achieved a more than 20% reduction of spleen volume.

REMARK Phase II study

The Phase II REMARK study (NCT06243458) is being conducted as an investigator-initiated trial within the European Myelodysplastic Neoplasms Cooperative Group (EMSCO), with Prof. Uwe Platzbecker serving as the Coordinating Principal Investigator. This study explores romaciclib as a monotherapy for the treatment of patients with low-risk myelodysplastic syndromes (LR-MDS). The REMARK study has commenced enrollment of patients across five countries: Poland, Germany, France, Spain and Italy, with a total of 20 clinical sites initiated across these countries. Planned overall enrollment in the study

was set at approximately 40 patients. The first patient in the REMARK study was treated on September 19, 2024, and enrollment was completed in May 2025.

An oral presentation providing the scientific rationale for this study was presented at the EHA Congress in June 2025. It could be shown that romaciclib significantly enhances erythropoiesis in MDS primary cells at clinically relevant and lower doses, supporting its potential as a therapeutic strategy in this indication. The presence of ASXL1 mutations in romaciclib-sensitive samples may provide a patient stratification approach to enrich for responders.

On November 3rd, Ryvu announced the acceptance of a poster presentation of initial results of the REMARK study at the ASH Annual Meeting and Exposition in December 2025. At the time of abstract submission in July 2025, one patient that failed three prior lines treatment achieved a major erythroid response.

RIVER-52 Phase II study

RIVER-52 is a multicenter, open-label clinical trial designed to assess the safety, tolerability, anti-tumor activity (efficacy), pharmacokinetics (PK), and pharmacodynamics (PD) of romaciclib as a monotherapy in patients with genetically defined subtypes of AML (including NPM1 and DNMT3a mutations), as well as with HR-MDS, without alternative treatment options. The latest data update was presented at the EHA Congress in June 2025. Romaciclib showed an acceptable safety profile at the dose of 250 mg QOD in patients with relapsed or refractory AML. Nausea, vomiting, and infectious complications were among the most frequent events, consistent with prior findings from Phase 1 and with the risk profile of the patient population under investigation. Despite relevant blast reductions in some patients, no durable complete responses were observed in the investigated patient populations. Although single agent activity of romaciclib in patients with AML cannot be excluded, the Company announced on February 25, 2025, that the study would not recruit new patients. The results of this study will however be included in the romaciclib safety database, supporting potential future regulatory approvals.

The Phase II studies mentioned above are part of romaciclib's Clinical Development Plan, presented in October 2023, and align with the Company's cash runway to H2 2026.

Additionally, multiple translational research activities are underway, aimed at further confirming romaciclib's mechanism of action, defining the target patient population, identifying potential combination partners, and validating romaciclib in other hematological and solid tumor indications, including combination studies and academic collaborations on medulloblastoma and sarcoma.

Dapolsertib (MEN1703, SEL24)

Dapolsertib (also known as MEN1703 or SEL24) is a selective, small-molecule dual inhibitor of PIM and FLT3 kinases, two enzymes strongly implicated in the malignant transformation of hematopoietic cells and lymphomagenesis. The compound has been discovered by Ryvu and is currently in clinical development in collaboration with Menarini Group as a therapeutic option for various cancers. The licensing agreement with Menarini was executed in March 2017. Initially, dapolsertib was developed as a potential treatment for patients with relapsed/refractory acute myeloid leukemia (AML). More details of the completed Phase I/II clinical study can be found at ClinicalTrials.gov under the identifier NCT03008187. Data from this part of the study were presented at multiple scientific conferences and symposia. Ryvu has been supporting this project with translational research.

Based on a decision announced in September 2023, Menarini continues the development of dapolsertib by initiating a new Phase II study in patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) – JASPIS-01 study. Menarini fully funds all study activities, while Ryvu acts as the operational partner to execute JASPIS-01 study on behalf of Menarini. Translational work in other hematologic indications also continues. The licensing partnership with Menarini, including the total milestones and royalties due to Ryvu upon achieving certain events, remains unchanged.

The JASPIS-01 study is an open-label, Phase II clinical trial investigating dapolsertib as a monotherapy and in combination with glofitamab for patients with relapsed/refractory (r/r) diffuse large B-cell lymphoma (DLBCL). It comprises three parts: Part 1 focuses on evaluating safety and preliminary antilymphoma activity in approximately 18 patients; Part 2, based on Part 1 results, will assess anti-tumor activity as a primary objective in a larger group of patients, as well as safety and tolerability; and Part 3 will offer an optional randomized comparison.

The JASPIS-01 study was initiated in Q4 2024. On March 26, 2025, Ryvu announced dosing of the first patient. The study was initiated at clinical sites in Poland. Currently, it is also recruiting in France, Spain, and the United Kingdom. The study is registered on ClinicalTrials.gov under NCT06534437.

On November 3rd, Ryvu announced the acceptance of a Trial-in-Progress poster presentation of the JASPIS study at the ASH Annual Meeting and Exposition in December 2025.

PRECLINICAL AND DISCOVERY STAGE PROJECTS

Synthetic lethality projects

RVU305 Oral, brain-penetrant, MTA-cooperative PRMT5 inhibitor in IND/CTA-enabling studies

RVU305 is a potentially best-in-class, oral, brain-penetrant, MTA-cooperative PRMT5 inhibitor currently in IND/CTA-enabling studies. It is designed to target cancers characterized by deletion of the MTAP metabolic gene, a genetic alteration found in approximately 10–15% of all human tumors. Loss of MTAP leads to substantial accumulation of methylthioadenosine (MTA) within cells. At high concentrations, MTA acts as a highly selective inhibitor of the PRMT5 methyltransferase, specifically competing with its substrate, S-adenosylmethionine (SAM). In MTAP-deleted cells, MTA accumulation results in partial inhibition of PRMT5's methylation function, which in turn reduces symmetric arginine dimethylation across the proteome and increases cellular vulnerability to further modulation of methylosome activity. RVU305 leverages this vulnerability as an MTA-cooperative PRMT5 inhibitor, selectively impeding the growth of cancer cells harboring MTAP deletions.

During the reporting period, RVU305 advanced through key preclinical milestones—including toxicology and API/IMP manufacturing—with the objective of completing IND/CTA-enabling activities by Q4 2025. Repeated-dose toxicity studies were conducted, and a starting-dose range was defined for GLP (Good Laboratory Practice) toxicity studies in two species. Those GLP studies were completed with no major toxicology findings and a favorable safety profile. The resulting preclinical safety data will inform calculation of the first-in-human (FIH) starting dose. In parallel, synthesis of a GMP batch was completed and manufacturing of the final clinical-trial drug product was initiated, further supporting the planned Q4 2025 timeline.

In vivo preclinical data demonstrated that RVU305 treatment led to significant tumor growth inhibition (TGI) and good tolerability in an orthotopic U87-LUC glioblastoma mouse model. Notably, RVU305 showed CNS penetration with predicted efficacious brain exposure in cynomolgus monkeys, and Kp,uu modeling indicated brain target coverage significantly superior to a clinical-stage comparator. Together, these findings position RVU305 as a promising therapeutic candidate capable of delivering targeted, brain-penetrant efficacy for MTAP-deleted gliomas (GBM), addressing a critical unmet need in GBM.

Data on the Company's MTA-cooperative PRMT5 inhibitors, and specifically the RVU305 preclinical candidate, were presented at the annual AACR-NCI-EORTC conference in Boston, United States, in October 2025. Poster presentations are available on the company website at the following link: https://ryvu.com/investors-media/publications/

Novel Multi-Target Discovery

ONCO Prime –Novel Small Molecule Precision Oncology

In addition to disclosed projects, Ryvu is accelerating internal initiatives focused on identifying and validating novel synthetic lethal and precision oncology targets for first-in-class small-molecule drug discovery programs. In June 2024, Ryvu finalized a funding agreement with the Polish Agency for Enterprise Development (PARP) and expects to receive approximately \$6.6 million (PLN 26.3 million) in grant funding over five years to support the proprietary ONCO Prime discovery platform. The company is utilizing these funds to accelerate the development of ONCO Prime, including the expansion of its primary biobank and target discovery efforts across several cancer indications, such as lung adenocarcinoma and triple-negative breast cancer (TNBC).

Through the ONCO Prime platform, we have successfully identified new precision oncology targets in colorectal cancer and are advancing small-molecule programs in this area. Ryvu presented recent progress on the ONCO Prime platform at the Discovery on Target conference in Boston in September, as well as at the AACR-NCI-EORTC conference in Boston and the SMR Target Identification and Validation in Drug Discovery conference in Cambridge, UK, in October. Poster presentations from the conferences are available on the company website at the following link: https://ryvu.com/investorsmedia/publications/.

Our research was also published in Nature Scientific Reports in the article "Integrated transcriptomic and functional modeling reveals AKT and mTOR synergy in colorectal cancer" (Sci Rep. 2025 Jul 31;15(1):26643. doi: 10.1038/s41598-025-08649-0).

ADC – Novel ADC payloads

Beyond its ONCO Prime Platform, Ryvu has leveraged its expertise in small-molecule discovery and target selection to advance projects in the small-molecule payload and ADC space. Building on the success of its collaboration with Exelixis, the company is developing additional payload programs and ADCs aimed at improving efficacy and safety over traditional chemotherapy-based approaches. Ryvu's research focuses on cytotoxic, immunocytotoxic, and other innovative payloads within its core therapeutic areas.

STING agonist ADC collaboration with Exelixis

In July 2022, Ryvu signed a licensing agreement with Exelixis to collaborate on novel targeted therapies based on the advanced STING agonist technology developed at Ryvu. To date, Ryvu has received USD 3 million from Exelixis as an upfront payment, and an additional USD 3 million in total in milestone payments for the achievement of certain development milestones from Exilixis. The partnership has developed highly potent STING-activating antibody-drug conjugates that demonstrate picomolar in vitro activity and antigen-specific activation of the STING pathway; further development of these compounds is currently ongoing. Current progress on the project remains confidential.

BioNTech: Multi-target research collaboration

In November 2022, BioNTech and Ryvu initiated a comprehensive, multi-target research collaboration to advance small-molecule programs focused on immune modulation in cancer and potentially other disease areas. Under this partnership, BioNTech has the right to acquire global development and commercialization rights for these programs. While multiple research initiatives are underway as part of this collaboration, detailed information about these programs remains confidential.

BioNTech: Clinical collaboration

In September 2025, Ryvu concluded a strategic agreement with BioNTech to provide specialized services aimed at accelerating site activation and patient enrollment for several of BioNTech's priority oncology clinical programs in Poland, covering indications such as lung, breast, and colorectal cancers. Under the agreement, both parties will leverage Ryvu's operational excellence, extensive expertise in oncology clinical operations, and established trial site network to enhance and streamline Polish patients' access to BioNTech's investigational immunotherapies.

2.2. Significant events in Q1- Q3 2025

2.2.1. DURING THE REPORTING PERIOD

Termination of STING program under Research Collaboration Option and Exclusive License Agreement with BioNTech SE

On January 29, 2025, BioNTech SE, with its registered office in Mainz, Germany ("BioNTech"), notified the Company that for reasons relating to change of BioNTech's portfolio strategy, the collaborator has decided to exercise its right to terminate the STING program covering Ryvu's STING agonist portfolio as standalone small molecules ("STING Program"; RVU312) along with two other of several previously undisclosed  programs, which were implemented under the research collaboration and exclusive license agreement dated November 29, 2022 ("License Agreement").

As a result of the abovementioned termination, upon the expiration of the 3-month notice period, all licenses covering the terminated programs granted by the Company to BioNTech under the License Agreement expired. Ryvu regained full rights to the STING Program as standalone small molecules. 

BioNTech and Ryvu continue their multi-target research collaboration in the field of small-molecule immunotherapy under the terms and conditions concluded in the License Agreement, including the funding by BioNTech of all discovery, research, and development activities thereunder.

Conclusion of funding agreement with the Małopolska Centre for Entrepreneurship

On February 14, 2025, a funding agreement ("Agreement") was concluded with the Małopolska Centre for Entrepreneurship ("MCP") for the Company's project titled: "InfraADC - Research infrastructure enabling R&D activities on Antibody-Drug Conjugates (ADC) as next generation targeted therapies in oncology" ("Project").

The aim of the Project is to implement new technologies not previously used by the company and to adapt the DMPK (bioanalytical), biochemical, and biological laboratories accordingly. As part of the Project, the Company plans to purchase specialist research equipment and software to control and support the operation of these devices. The acquired equipment will enable work on the technology of drug-antibody conjugates (ADC). As part of the planned R&D work, the Company plans to launch new production processes, understood as a research process for the discovery and development of innovative oncological drugs, and to expand its product portfolio with ADC projects in oncology.

  • the total value of the Project is: PLN 7,523,159.70;
  • recommended amount of the funding: PLN 3,085,312.00;
  • assumed project implementation period: 24 months.

The funding granted in connection with the conclusion of the Agreement will reduce the Company's reliance on its funds.

Ryvu Therapeutics announces strategic reorganization to extend the cash runway for the development of romaciclib and the preclinical pipeline

On February 25, 2025, the Management Board of the Company announced its decision to undertake strategic reorganization measures aimed at extending the Company's cash runway from Q1 to H2 2026, with a focus on driving the romaciclib clinical program and the early pipeline to key data inflection points.

As part of the strategic reorganization mentioned above, the Company has taken actions primarily in two areas:

    1. Workforce reduction
    1. Pipeline adjustments.

Re 1. Workforce reduction

The Management Board of the Company informed about the completion of the consultation procedure with the representatives of the Company's employees on the intention to carry out a collective redundancy in the Company (the "Collective Redundancy") and about the adoption of the rules of the Collective Redundancy specifying the rules of conduct in matters concerning the employees affected by the intended Collective Redundancy and about the decision of the Management Board of the Company to carry out the Collective Redundancy on the terms set out in the established rules. The Collective Redundancy was carried out from February 25, 2025, to June 30, 2025, and affected approximately 30% (no more than 95) of the Company's employees. As a result of the Collective Redundancy, the Company still employed approximately 200 employees, retaining its full potential to develop the projects described below.

Re 2. Pipeline adjustments

The Management Board has made decisions regarding changes to the project pipeline. Current status and key project objectives in the period 2025-2026:

In case of RIVER-52 – a Phase II clinical trial of romaciclib as a monotherapy in patients with r/r AML or HR-MDS – initiated as in the Current Report No. 10/2024 dated February 14, 2024, the Management Board of Ryvu decided to suspend the enrolment of new patients to focus investment on the other romaciclib development paths. Currently enrolled patients will continue to receive treatment per protocol. Other romaciclib Phase II studies (RIVER-81, POTAMI-61, and REMARK) progress as planned. The decision to progress RIVER-81 and suspend enrolment in RIVER-52 was based on data analysis and feedback from advisory boards in February 2025.

In the RVU305 program, which the Company announced in Current Report No. 28/2024 dated September 10, 2024, IND/CTA-enabling studies are ongoing. Their completion is planned for the second half of 2025.

For preclinical discovery and research, the Company will pursue a dual-pronged strategy, each of which has the potential to generate multiple oncology medicines:

  • (i) ONCO Prime novel small molecule precision medicine: as part of its proprietary ONCO Prime platform, Ryvu will continue to advance several novel precision oncology targets, including synthetic lethality targets.
  • (ii) ADCs (antibody-drug conjugates) with novel payloads: Ryvu will continue to develop ADCs with next-generation novel payloads, including synthetically lethal and immunomodulatory mechanisms. Ryvu will develop novel ADCs internally and through its existing collaboration with Exelixis, focusing on STING-based ADCs. The WRN program, which was previously focused on standalone development, will be developed as a novel ADC payload program to differentiate itself in terms of efficacy, resistance profile, and safety compared to competitors.

Ryvu continues to advance three key biopharma partnerships (BioNTech, Exelixis, and Menarini), unchanged from its previous status, retaining full reimbursement for its expenses and the potential to earn financial milestones.

Dosing of the first patient in the JASPIS-01 phase II study of dapolsertib (MEN1703, SEL24) for the treatment of patients with relapsed/refractory (r/r) diffuse large B-cell lymphoma (DLBCL)

On March 26, 2025, the first patient was dosed with dapolsertib (MEN1703, SEL24) in the JASPIS-01 study ("JASPIS-01 Study") for the treatment of patients with relapsed/refractory (r/r) diffuse large Bcell lymphoma (DLBCL). The JASPIS-01 Study is being conducted by Syneos Health, LLC, a Delaware limited liability company with principal offices located in the United States at 1030 Sync Street, Morrisville, North Carolina 27560, together with Syneos Health UK Limited, a company with principal offices located at Farnborough Business Park, 1 Pinehurst Road, Farnborough, Hampshire, GU14 7BF, England, Europe, as announced by the Company in current report no. 31/2024 dated October 18, 2024.

The JASPIS-01 Study is an open-label, Phase II clinical trial investigating dapolsertib as monotherapy and in combination with glofitamab for the treatment of patients with relapsed/refractory (r/r) DLBCL. It comprises three parts: Part 1 focuses on evaluating safety and preliminary anti-tumor activity in approximately 18 patients; Part 2 will assess, based on the results of Part 1, anti-tumor activity as a primary objective in a larger group of patients, as well as safety and tolerability; and Part 3 will offer an optional randomized comparison to show the contribution of dapolsertib and glofitamab over glofitamab alone. The JASPIS-01 Study is registered on ClinicalTrials.gov under NCT06534437.  The

JASPIS-01 Study was initiated at clinical sites in Poland, with plans to expand to additional EU and non-EU countries.

Dapolsertib hydrochloride is the new International Non-proprietary Name (INN) for MEN1703 (SEL24) as accepted by the World Health Organization (WHO). Dapolsertib is a selective, small-molecule, dual inhibitor of PIM and FLT3 kinases, two enzymes strongly implicated in the malignant transformation of hematopoietic cells and lymphomagenesis. The Company has discovered the compound, which is currently in clinical development in collaboration with Menarini (as defined below), as a potential therapeutic option for various cancers.

The license agreement with Berlin-Chemie AG, headquartered in Berlin, Germany, a part of the Italian Menarini Group ("Menarini"), was signed on March 28, 2017, as previously reported by the Company in current report no. 4/2017. Menarini holds global development and commercial rights to dapolsertib. Initially, dapolsertib was developed as a potential treatment for patients with relapsed/refractory (r/r) acute myeloid leukemia (AML). More details on the completed Phase I/II clinical study can be found at ClinicalTrials.gov under NCT03008187. Data from this study were presented at multiple scientific conferences and symposia.

Encouraged by promising results from translational research, Menarini decided to continue the development of dapolsertib by initiating a new Phase II study in patients with r/r DLBCL – the JASPIS-01 study. Menarini fully funds all study activities, while the Company serves as the operational partner for executing the JASPIS-01 Study on behalf of Menarini, as announced by the Issuer in the current report No. 40/2023, dated September 14, 2023.

Decision not to enter into a Grant Agreement with the Medical Research Agency

On April 8, 2025, Management Board of the Company decided not to enter into a grant agreement with the Medical Research Agency (in Polish: Agencja Badań Medycznych, "MRA") regarding the project titled: "Identification of selection markers for patients that can benefit from the treatment with novel PRMT5 developed by Ryvu Therapeutics" (Ref. No. KPOD.07.07-IW.07-0250/24). This project had previously been recommended for funding under the Call for Proposals for Entrepreneurs to Conduct Research in the Area of Drug Safety, Innovative Therapies, and Medicines of the Future (2024/ABM/05/KPO), as reported by the Issuer in Current Report No. 3/2025 dated February 7, 2025.

The decision to withdraw from signing the agreement results from a strategic shift in the scope of the Company's translational research, which will now focus on the treatment of tumors that may benefit from the newly identified blood-brain barrier–penetrating properties of RVU305 — such as gliomas and cancers with a high propensity to metastasize to the brain.

Conclusion of a grant agreement with the Medical Research Agency

On April 23, 2025, the Company concluded a grant agreement (the "Agreement") with the Medical Research Agency (in Polish: Agencja Badań Medycznych, "MRA") for the co-financing of the Company's project entitled: "ADCraft – next-generation small-molecule payloads for antibody-drug conjugates in oncology" (the "Project"). The Company had previously informed about the recommendation of the Project for co-financing in Current Report No. 2/2025 dated February 7, 2025.

The aim of the Project is to develop methods for discovering and testing the new generation of payloads for Antibody-Drug Conjugates (ADC), along with a portfolio of R&D activities focused on new therapeutic modalities used in oncology.

  • the total net value of the Project is: PLN 13,172,227.85;
  • recommended amount of the funding: PLN 9,879,170.99;
  • the planned duration of the Project: 18 months.

In case the grant agreement is concluded and the Project is implemented, the granted funding may limit the use of the Company's funds.

Posters on preclinical data on RVU305 and Synthetic Lethality Programs presented at the 2025 AACR Annual Meeting

The Company presented preclinical data on the RVU305 program and its synthetic lethality platform at the 2025 AACR Annual Meeting, held from April 25 to 30, 2025, in Chicago, United States.

Details on poster presentations are as follows:

Poster Title: "Preclinical candidate RVU305, an MTA-cooperative PRMT5 inhibitor, shows activity in MTAP-deleted tumors resistant to immune checkpoint treatment." 

Session Name: HDAC and Methyltransferase Inhibitors 

Session date and time: Tuesday, April 29, 9:00 AM - 12:00 PM EST 

Poster Number: 17  

RVU305, a potentially best-in-class, brain-permeable MTA-cooperative PRMT5 inhibitor, demonstrates significant potential in targeting MTAP-deleted cancers. In preclinical studies, RVU305 effectively inhibited tumor growth in MTAP-null cancer models without affecting normal cells. RVU305 also demonstrated CNS penetration with predicted efficacious exposure in the brain in cynomolgus monkeys. In CNS cell lines, RVU305 exhibited high potency and efficacy. Furthermore, co-treatment with an anti-PD-1 antibody was well tolerated and resulted in antitumor activity in an MTAP-deleted model resistant to immune checkpoint inhibitors (ICI). The efficacy of RVU305 was supported by pharmacodynamic changes observed in tumor tissue. These results position RVU305 as a promising therapeutic option for patients with MTAP-deleted cancers that are resistant to ICI. 

Poster Title: "Discovery of novel synthetic lethal targets for effective and safe colorectal cancer therapies." 

Session Name: Experimental and Molecular Therapeutics 

Session date and time: Monday, April 28, 2:00 PM - 5:00 PM EST  

Poster Number: 3  

This study highlights the discovery and validation of novel therapeutic targets for colorectal cancer (CRC) through synthetic lethal (SL) interactions, addressing the urgent need for more effective and personalized treatment options for this disease. The team identified key vulnerabilities in CRC using advanced models, including genetically engineered human intestinal stem cells (hISCs) and patientderived xenografts (PDXs) in combination with CRISPR/Cas9 technology. 

Genome-wide SL screens identified targets associated with common CRC driver mutations, particularly those involving APC and KRAS. These findings were robustly validated. Notably, knock-out of the identified target selectively killed mutant patient-derived cells while sparing healthy intestinal stem cells, demonstrating a favorable therapeutic window. 

Furthermore, we identified small-molecule inhibitors that block the activity of the newly discovered target. These compounds modulate downstream biomarkers and phenocopy the differential effects observed in our genetic studies, thereby supporting the translational potential of this approach. 

Together, these results lay the groundwork for developing targeted therapies tailored to the genetic makeup of CRC tumors. 

Receipt of a notification under Article 69 of the Public Offering Act from TFI Allianz Polska S.A. regarding the decrease below the 5% threshold of the total number of votes in the Company

On May 2, 2025 Management Board of the Company received a notification from TFI Allianz Polska S.A., acting on behalf of the following funds: Allianz FIO, Allianz Inwestycje SFIO, Allianz Plan Emerytalny SFIO, and Bezpieczna Jesień SFIO (the "Funds"), prepared in accordance with Article 69(1)(1) and Article 87(1)(2)(a) of the Act of 29 July 2005 on Public Offering, Conditions Governing the Introduction of Financial Instruments to Organized Trading, and Public Companies, regarding a decrease below the 5% threshold of the total number of votes at the Company's General Meeting.

According to the content of the notification, as a result of a sale transaction of the Company's shares carried out on 28 April 2025 (settlement date: 30 April 2025), the total share of the Funds in the total number of votes at the General Meeting of the Company decreased below the 5% threshold and currently amounts to 4.96%.

Changes in the Management Board of Ryvu Therapeutics S.A.

On May 27, 2025, the Supervisory Board of the Company, acting pursuant to Article 368 § 4 of the Polish Commercial Companies Code (k.s.h.), appointed Ms. Justyna Żółtek to the Management Board of the Company, effective as of June 1, 2025.

Ms. Justyna Żółtek joined the Company in 2021 and has served as Chief People Officer since May 2024. She is responsible for the Administration and HR functions, including all employee development processes and the Company's internal culture.

Data on romaciclib (RVU120) presented at the 2025 European Hematology Association Congress

The Company has presented data on romaciclib (RVU120) at the 2025 European Hematology Association Congress (EHA), which took place from June 12 to June 15 in Milan, Italy.

Details on the oral and poster presentations are described below. The presentation related to the presented posters is attached to this report.

# RVU120 in combination with venetoclax in AML

Poster PS1509: Preliminary results from RIVER-81, a Phase II study of RVU120+VEN in patients with AML failing first-line VEN+HMA

Session date and time: 14 June 2025, 6:30 pm – 7:30 pm CEST

Preliminary results from the open-label RIVER-81 Phase II clinical study demonstrate that RVU120, when combined with venetoclax (VEN), shows promising anti-leukemic activity in patients with relapsed or refractory acute myeloid leukemia (r/r AML) who failed first-line VEN-based treatment. As of May 14, 2025, 43 patients had been treated, of which 27 patients were evaluable for response across exploratory Parts 1 and 2. In total, 7 out of 27 evaluable patients (26%) achieved a complete remission with or without incomplete hematologic recovery (CR/CRi). One out of three evaluable patients from Cohort 2 achieved a complete remission (CR). 3 out of 13 evaluable patients

from stage 1 of Part 2 achieved a complete remission with incomplete count recovery (CRi), suggesting that RVU120 may help overcome VEN resistance. With optimized dosing in Cohort 4 (150mg of RVU120 QD + 400mg VEN), the efficacy results have further improved – the CR rate in the evaluable population in this cohort was 50% (3 out of 6 patients. As of June 6, 2025, 4 patients who have achieved a CR/CRi across all cohorts remain in remission on study treatment. The study continues enrollment in Cohort 6 at a dose of 200mg of RVU120 QD + 400mg VEN, with the potential to maximize the duration of response. The study supports further exploration of RVU120+VEN as a potential therapeutic strategy for AML with poor prognosis. The combination has been tolerated, with nausea as the most common adverse event.

Poster PF415: Overcoming venetoclax resistance: synergistic potential of RVU120, a CDK8/CDK19 inhibitor, in combination treatment

Session date and time: 13 June 2025, 6:30 pm – 7:30 pm CEST

RVU120 demonstrates strong synergy when combined with venetoclax (VEN) to overcome resistance to VEN in the treatment of AML. Preclinical studies reveal that RVU120+VEN effectively targets key VEN resistance pathways, including IL6/JAK/STAT3, TGF-β, and PI3K/AKT/mTOR. The combination also retains efficacy in models of bone marrow stroma-mediated resistance, a common mechanism of therapy failure. These findings support the ongoing Phase II RIVER-81 trial, exploring RVU120+VEN in patients with AML who have failed prior VEN-based treatments. This research underscores RVU120's potential to improve treatment outcomes by overcoming venetoclax resistance in AML.

# RVU120 as a monotherapy and in combination with RUX in MF

Poster PF861: An Open-Label Clinical Trial of RVU120 as Monotherapy and in Combination with Ruxolitinib in Patients with Intermediate or High-Risk, Primary or Secondary Myelofibrosis (POTAMI-61)

Session date and time: 13 June 2025, 6:30 pm – 7:30 pm CEST

The open-label POTAMI-61 Phase II clinical trial evaluates RVU120 as a monotherapy and in combination with ruxolitinib (RUX) for patients with intermediate or high-risk myelofibrosis (MF). As of May 14, 2025, 21 patients were treated, completing the enrollment in the exploratory part. The median time on treatment was 10 weeks, with 8 patients completing at least 12 weeks of treatment, but no patient had met the follow-up for the primary endpoint at 24 weeks due to insufficient time on study. The ongoing trial is assessing spleen volume reduction, symptom burden, and safety over a 24-week period. Initial signs of clinical activity were observed in selected patients: TSS improvement was noted in 3 out of 4 patients at week 12; initial changes in spleen size reduction were observed in 4 out of 8 patients. Considering the early read-out after only 12 weeks, the data are encouraging and warrant further exploration of RVU120 in patients with MF. RVU120 was found to be tolerated by patients with MF, both when used as a single agent or in combination with RUX. The full week 24 data are anticipated in Q4 2025.

# RVU120 in MDS

Oral Presentation: RVU120 enhances erythroid potential in MDS patient-derived cells: preclinical mechanistic insights into CDK8/CDK19 inhibition and potential patient stratification

Session date and time: 12 June 2025, 5:00pm – 6:15pm CEST

Session title: s450 MDS cellular and molecular therapeutic targeting

RVU120 demonstrates significant potential in enhancing erythroid differentiation in MDS patientderived cells confirmed by transcriptomic and functional analysis. Data show that RVU120 promotes erythropoiesis in CD34+ bone marrow cells derived from MDS patients, particularly benefiting those with differentiation defects. Results from multiple patient-derived samples indicate potential patient stratification based on ASXL1 mutations. These findings support RVU120 as a promising therapeutic candidate in the REMARK Phase II clinical study in patients with low-risk myelodysplastic syndromes (LR-MDS).

# RVU120 as a monotherapy in AML

Poster PF548: RIVER-52: A Multicenter, Open-Label Clinical Trial of RVU120 in Patients with Relapsed or Refractory High-Risk Myelodysplastic Syndrome or Acute Myeloid Leukemia

Session date and time: 13 June 2025, 6:30 pm – 7:30 pm CEST

The open-label RIVER-52 Phase II clinical study evaluated RVU120 monotherapy in patients with acute myeloid leukemia (AML) or relapsed or refractory high-risk myelodysplastic syndrome (HR-MDS). As of May 14, 2025, 39 patients received RVU120 (27 AML and 12 HR-MDS patients). RVU120 demonstrated a manageable safety profile, with gastrointestinal and infectious adverse events being the most common. Two patients, one NPM1-mutated and one DNMT3A-mutated, showed more than 50% bone marrow blast reduction at their C2D13 disease assessment. A patient with HR-MDS achieved a CR but was lost to follow-up. Despite relevant blast reductions in some patients, no durable CRs were observed, and enrollment was suspended. The data collected will be used to support the RVU120 safety and efficacy database.

Conclusion of Strategic Agreement with BioNTech SE to Support Clinical Trials for BioNTech's Investigational Cancer Immunotherapies in Poland

On September 1st, 2025, Ryvu has concluded a Strategic Agreement ("Agreement") with BioNTech SE, with its registered office in Mainz, Germany ("BioNTech"). The Agreement is of a framework nature, and specific services will be performed by Ryvu under SOWs (Scope of Work) submitted by BioNTech.

As of the date of execution of the Agreement, the total value of SOWs attributed to Ryvu is € 2,946,000 (PLN 12,542,300 converted at the average exchange rate of the National Bank of Poland on September 1st, 2025, 1 EUR = 4.2574 PLN). Based on the SOWs received, the Company will support BioNTech in the acceleration of site activation and patient enrolment for several of BioNTech's priority oncology clinical programs in Poland, in indications such as lung, breast, and colorectal cancers.

By entering into the Agreement, the parties expand the scope of their current cooperation carried out under the exclusive research collaboration and license agreement concluded on November 29, 2022 ("License Agreement"), which the Company announced in its current report No. 26/2022. Based on the Agreement, the parties plan to leverage Ryvu's operational excellence, expertise in oncology clinical operations and existing trial site network to streamline access of Polish patients to BioNTech's investigational immunotherapies.

Romaciclib to be tested in an investigator-initiated Phase I study to treat pediatric patients with medulloblastoma

The Company has initiatied a collaboration with the Children's Memorial Health Institute (pl. Instytut "Pomnik – Centrum Zdrowia Dziecka", "IPCZD", "the Institute") as part of the MEDWAY project

("MEDWAY Project") – a new, non-commercial Phase I clinical study aimed to evaluate the CDK8/19 inhibitor romaciclib in combination with everolimus in children with recurrent or progressive Group 3 or 4 medulloblastoma. On September 9, 2025, IPCZD signed a funding agreement with the Polish Medical Research Agency (pl. Agencja Badań Medycznych "MDR") for the MEDWAY Project under a grant awarded in ABM's call for non-commercial clinical trials and research experiments in oncology (ABM/2024/2). The study will assess the safety and potential efficacy of romaciclib in combination with everolimus, targeting unique molecular mechanisms of the disease.

The study will be led by Prof. Bożenna Dembowska-Bagińska and the clinical team at IPCZD's Oncology Clinic, in collaboration with the research teams of Prof. Wiesława Grajkowska and Prof. Joanna Trubicka. The MEDWAY Project will be supported by the Pediatric Clinical Trials Support Center and the Pediatric Regional Center for Digital Medicine operating at IPCZD. Medulloblastoma is one of the most common and aggressive forms of childhood brain cancer, with limited treatment options, especially for recurrent or progressive cases.

The total value of the grant awarded to IPCZD under the MEDWAY Project is PLN 40,151,060.47. Of this amount, approximately PLN 2 million is allocated in the MEDWAY Project budget directly to cover the costs of manufacturing, preparing, and releasing the investigational medicinal product – romaciclib – for use in the planned clinical trial. These funds cover only the production costs, excluding commercial markups or margins; however, the Company will not bear any costs related to the supply of romaciclibfor the study. The first shipment of romaciclib is expected in Q2 2026. The MEDWAY Project is expected to run from July 1, 2025, to June 30, 2033, with the potential for earlier completion. Ryvu will work closely in collaboration with the IPCZD team throughout the study.

2.2.2. EVENTS OCCURRED BETWEEN THE END OF REPORTING PERIOD UNTIL THE APPROVAL OF FINANCIAL STATEMENT

RVU305 (PRMT5i) and ONCO Prime Platform data to be presented at the 2025 AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics

The Company presented preclinical data on RVU305 (PRMT5i) and the ONCO Prime Platform at the 2025 AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics, October 22-26, 2025, in Boston, MA.

Details on the poster presentations are as follows:

Poster Title: "RVU305, a brain-penetrant MTA-cooperative PRMT5 inhibitor, shows efficacy in GBM

preclinical models" Poster Number: B037

Session date and time: Friday, October 24, 12:30 PM - 4:00 PM EST

RVU305, a potentially best-in-class, brain-permeable MTA-cooperative PRMT5 inhibitor, demonstrates significant promise in the treatment of MTAP-deleted cancers. Preclinical studies show that RVU305 selectively inhibits PRMT5 activity in MTAP-deleted cells, inducing a strong synthetic lethal effect while

sparing regular counterparts. Mechanistically, RVU305 causes a dose-dependent reduction in SDMAmodified proteins, validating PRMT5 inhibition at the molecular level. Moreover, RVU305 delivers selective inhibition of PRMT5 in MTAP-deleted tumor cells. Its BID oral dosing and MTA-cooperative mechanism enable potent, on-target tumor inhibition while sparing healthy tissue. This translates into >100% tumor growth inhibition and multiple complete responses in MTAP-deleted models.

RVU305 demonstrates potent antiproliferative activity across multiple MTAP-deleted glioblastoma (GBM) cell lines with minimal effects on MTAP wild-type lines. In vivo, RVU305 showed significant tumor growth inhibition (TGI) and good tolerability in an orthotopic U87-LUC glioblastoma mouse model. RVU305 demonstrated CNS penetration with predicted efficacious exposure in the brain of cynomolgus monkeys. Kp,uu modeling indicates brain target coverage significantly superior to clinical stage comparator.

Together, these findings position RVU305 as a promising therapeutic candidate capable of delivering targeted, brain-penetrant efficacy for MTAP-deleted gliomas, addressing a critical unmet medical need in GBM treatment. GLP toxicology studies for RVU305 have been completed with no major toxicology findings and favorable safety profile which supports planned completion of IND/CTA-enabling studies in Q4 2025.

Poster Title: "Identification of novel molecular vulnerabilities in colorectal cancer through integrated transcriptomic profiling and functional genomics"

Poster Number: B050

Session date and time:  Friday, October 24, 12:30 PM - 4:00 PM EST

This study describes the development of a comprehensive discovery platform designed to identify synthetic lethal (SL) interactions linked to major oncogenic drivers in colorectal cancer (CRC), including APC, KRAS, and SMAD4. By combining CRISPR-based functional screening with genomic and transcriptomic analyses across human intestinal stem cell (hISC)-derived isogenic models, patientderived cells (PDCs), and clinical tumor specimens, the team uncovered novel molecular vulnerabilities specific to genetically defined CRC subtypes. Machine learning applied to RNA sequencing data enabled precise molecular subtyping and validation of model fidelity, while candidate targets were selected based on therapeutic relevance and selectivity for cancer cells. Through this integrated approach, three categories of actionable targets were identified:

  • first-in-class synthetic lethal targets currently under active drug discovery and optimization,
  • next-wave novel dependencies representing promising directions for future oncology programs,
  • novel indications for FDA-approved drugs supporting opportunities for drug repurposing.

Together, these findings establish a robust framework for precision oncology, supporting the discovery of new targeted therapies for CRC and offering broad applicability to other cancer types. .

All posters are now available online and can be obtained from the conference site:  https://www.aacr.org/ and https://ryvu.com/

Presentation of data on Romacyclib and Dapolsertib at the 2025 Annual Meeting of the American Society of Hematology (ASH)

The Company will present the latest data on romacyclib (RVU120) and dapolsertib (MEN1703) during the 2025 Annual Meeting of the American Society of Hematology (ASH), which will take place on December 6–10, 2025, in Orlando, USA

Details on the abstracts, which were submitted on July 31, 2025, are as follows:

Abstract Title: Preliminary results from RIVER-81, a phase 2 study of romaciclib (RVU120) + venetoclax in patients with acute myeloid leukemia failing first-line venetoclax + hypomethylating agent (HMA) Session name: 616. Acute myeloid leukemias: Investigational drug and cellular therapies: Poster 2

Session date and time: December 7, 6:00-8:00 PM EST

Poster number: 3424

The Phase II RIVER-81 study evaluates the combination of romaciclib (RVU120), a selective CDK8/CDK19 inhibitor, with venetoclax (VEN) in patients with relapsed or refractory AML following frontline VEN+HMA therapy. As of July 11, 2025, 48 patients with relapsed/refractory AML after VEN+HMA failure were treated in the ongoing RIVER-81 study. No dose-limiting toxicities were observed up to romaciclib 200 mg QD combined with venetoclax 400 mg QD, supporting favorable tolerability across dose levels. Pharmacokinetic analyses confirmed dose-proportional exposure, and pharmacodynamic assessments demonstrated robust inhibition of STAT5 phosphorylation, consistent with on-target CDK8/19 activity. The most common adverse events were low-grade gastrointestinal symptoms, anemia, febrile neutropenia, and pneumonia. Among 28 evaluable patients, composite complete remission (CR + CRi) rates were 23% in Stage 1 of Part 2 and 43% among treated patients in Cohort 4, with several ongoing durable responses. In Cohort 6, two patients were evaluable, with one achieving a CRi and the other patient achieving a substantial blast reduction. Five of eight responding patients remain on therapy, with durations ranging from 0.6 to 7 months. Early efficacy signals suggest romaciclib may restore sensitivity to venetoclax in resistant AML. These findings support continued enrollment and further evaluation of romaciclib + VEN as a potential therapeutic option for patients with poor-prognosis AML.

Abstract Title: An open-label, phase I/II clinical trial of romaciclib (RVU120) as monotherapy and in combination with ruxolitinib in patients with intermediate or high-risk, primary or secondary myelofibrosis (POTAMI-61)

Session name: 634. Myeloproliferative syndromes: Clinical and epidemiological: Poster 1

Session date and time: December 6, 5:30-7:30 PM EST

Poster number: 2045

The Phase II POTAMI-61 study evaluates romaciclib (RVU120), a selective CDK8/19 inhibitor, as monotherapy and in combination with ruxolitinib (RUX) in patients with myelofibrosis (MF) who have failed or shown suboptimal response to JAK inhibitor therapy. As of July 25, 2025, 23 patients were enrolled in Part A (12 monotherapy, 11 combination), with enrollment in Part B ongoing. Romaciclib was administered in 21-day cycles, and treatment was generally well tolerated; the most common adverse events were grade 1–2 nausea (52%) and vomiting (43%). Grade 3 events included anemia, thrombocytopenia, nausea, vomiting, urinary tract infection, and fatigue, each reported in ≤3 patients. Among four evaluable patients, one achieved spleen volume reduction (SVR) ≥20% at 24 weeks, three showed some degree of SVR, and two achieved >50% reduction in total symptom

<-- PDF CHUNK SEPARATOR -->

score (TSS). One patient demonstrated complete symptom resolution, and another achieved improvement in bone marrow fibrosis after 12 weeks. Pharmacokinetic results confirmed expected exposure and no drug-drug interaction between romaciclib and RUX. These early data indicate that romaciclib is well tolerated and show initial clinical activity, supporting continued evaluation of romaciclib as a potential therapeutic option for patients with MF.

Abstract Title: REMARK: A phase II, open-label, multicenter study of orally administered romaciclib (RVU120) for the treatment of anemia in patients with lower-risk myelodysplastic neoplasms (LR-MDS)

Session name: 637. Myelodysplastic syndromes: Clinical and Epidemiological: Poster 3

Session date and time: December 8, 6:00-8:00 PM EST

Poster number: 5649

The Phase II REMARK study evaluates romaciclib (RVU120), an oral CDK8/CDK19 inhibitor, in patients with lower-risk myelodysplastic neoplasms (LR-MDS), a disease characterized by anemia and limited treatment options. As of the data cutoff, 42 patients had initiated treatment, of whom 15 remained on therapy. Romaciclib was administered at 150 mg every other day for 13 days in 21-day cycles, with an option to escalate to 250 mg in non-responders or relapsing patients. Preliminary results demonstrated early signs of clinical activity, including one patient with high transfusion burden (≥8 RBC units/16 weeks) who achieved a primary erythroid response (HI-E) per IWG 2018 criteria after 24 weeks of treatment. This responder carried an SF3B1 mutation and had previously failed three standard therapies (ESA, luspatercept, lenalidomide). No new safety signals were identified; the most frequent treatment-related adverse events were nausea, vomiting, asthenia, and decreased appetite. These AEs were predominantly low grade; however, they led to discontinuation in some patients. Ongoing analyses aim to define further romaciclib's erythroid activity, optimal dosing, and molecular predictors of response in LR-MDS.

Abstract Title: An open-label, phase 2 study of dapolsertib (MEN1703, SEL24) as monotherapy and in combination with glofitamab in patients with relapsed or refractory aggressive B-cell non-Hodgkin lymphoma

Session name: 627. Aggressive lymphomas: Targeted and pharmacologic therapies: Poster 3

Session date and time: December 8, 6:00-8:00 PM EST

Poster number: 5481

The Phase II JASPIS-01 study evaluates dapolsertib (MEN1703), a dual PIM/FLT3 kinase inhibitor, as monotherapy and in combination with the CD20xCD3 bispecific antibody glofitamab in patients with relapsed or refractory (R/R) aggressive B-cell lymphomas who have received at least 2 prior lines of therapy. Dapolsertib targets key oncogenic and survival pathways, including MYC- and BCL6 associated signaling, and has demonstrated preclinical synergy with anti-CD20 antibodies. The study aims to assess the safety, tolerability, and preliminary efficacy of dapolsertib while exploring its potential to overcome resistance associated with CD20 downregulation. In Part 1, patients are enrolled into two groups: bispecific-naïve patients receiving dapolsertib + glofitamab in doseoptimization cohorts, and heavily pretreated patients receiving dapolsertib monotherapy. Two dosing schedules are being explored – 125 mg (2 weeks on/1 week off) and 150 mg (1 week on/2 weeks off) – to identify the optimal therapeutic window. Dose selection for Part 2 will be guided by the Data

and Safety Monitoring Board, following safety review after ≥2 treatment cycles. As of July 11, 2025, enrollment in Part 1 is ongoing in France, Poland, Spain, and the UK, with additional site activations planned. This study represents the first clinical evaluation of dapolsertib in B-cell lymphoma and seeks to establish a foundation for novel combination strategies addressing resistance to CD20-targeted immunotherapies.

All abstracts are now available online and can be obtained from the conference site:  https://worldannualmeeting.com/ash/index.php

2.3. Unusual events occurring in the reporting period

Conflict in Ukraine

Due to the outbreak of the conflict in Ukraine, the Issuer's Management Board has analyzed the potential impact of the ongoing war on the Issuer's operations. In the opinion of the Management Board, apart from the currency risk, the Management Board did not identify any other significant risks that could affect the Issuer's operations.

In particular, it should be noted that the Issuer has no assets in Ukraine and does not conduct business and operations in Ukraine and Russia. The share of entities from Ukraine or Russia as suppliers in the Issuer's structure remains insignificant and is mostly limited to the provision of compound libraries for discovery stage projects at their early stage.

Nevertheless, the Management Board of the Company analyzes the Issuer's situation on an ongoing basis. Any new circumstances having a significant impact on the financial results and business situation of the Issuer will be communicated to investors.

3. THE ISSUER'S CORPORATE BODIES

Issuer's Management Board:

  • 1) Paweł Przewięźlikowski President of the Management Board
  • 2) Krzysztof Brzózka Vice President of the Management Board
  • 3) Kamil Sitarz Member of the Management Board
  • 4) Vatnak Vat-Ho Member of the Management Board
  • 5) Hendrik Nogai Member of the Management Board
  • 6) Justyna Żółtek Member of the Management Board

Issuer's Supervisory Board:

  • 1) Piotr Romanowski Chairman of the Supervisory Board
  • 2) Tadeusz Wesołowski Vice Chairman of the Supervisory Board
  • 3) Rafał Chwast Supervisory Board Member
  • 4) Axel Glasmacher Supervisory Board Member
  • 5) Thomas Turalski Supervisory Board Member
  • 6) Scott Z. Fields Supervisory Board Member
  • 7) Peter Smith Supervisory Board Member

Issuer's Audit Committee:

  • 1) Rafał Chwast Chairman of the Audit Committee
  • 2) Piotr Romanowski Member of the Audit Committee
  • 3) Tadeusz Wesołowski Member of the Audit Committee

Issuer's Remuneration Committee:

  • 1) Piotr Romanowski Chairman of the Remuneration Committee
  • 2) Axel Glasmacher Member of the Remuneration Committee
  • 3) Thomas Turalski Member of the Remuneration Committee

4. INFORMATION ON THE SHAREHOLDERS HOLDING (DIRECTLY OR INDIRECTLY) AT LEAST 5% OF THE TOTAL NUMBER OF VOTES AT THE GENERAL SHAREHOLDERS' MEETING OF THE COMPANY AND ON SHARES HELD BY MEMBERS OF THE ISSUER'S MANAGEMENT BOARD AND SUPERVISORY BOARD

Shares held by members of the Management and Supervisory Board of Ryvu Therapeutics S.A. as of 30.09.2025 and as of the date of Report publication

Shareholder Preferred shares* Ordinary
shares
Number
of shares
% of Share
Capital
Number
of Votes
% of
Votes
at SM
The Management Board
Paweł Przewięźlikowski 3 500 000 482 160 3 982 160 17,22% 7 482
160
27,54
%
Krzysztof Brzózka 267 321 267 321 1,16% 267 321 0,98%
Kamil Sitarz 39 230 39 230 0,17% 39 230 0,14%
Vatnak Vat-Ho 57 000 57 000 0,25% 57 000 0,21%
Hendrik Nogai 22 500 22 500 0,10% 22 500 0,08%
Justyna Żółtek 18 265 18 265 0,08% 18 265 0.07%
The Supervisory Board
Tadeusz Wesołowski (directly) 92 975 92 975 0,40% 92 975 0,34%
Tadeusz Wesołowski (indirectly through
Fundacja Rodzinna Rodziny Wesołowskich
Fundacja Rodzinna w Krakowie**)
1 279
738
1 279 738 5,54% 1 279 73
8
4,71%
Rafał Chwast 121 115 121 115 0,52% 121 115 0,45%
Thomas Turalski 20 100 20 100 0,09% 20 100 0,07%

*A single Series A share entitles to two votes at the Shareholder Meeting.

Shares held by significant shareholders of the Company

Shares held by significant shareholders of the Company as of 30.09.2025 and as of the date of Report publication

Shareholder Shares % [Shares] Votes % [Votes]
Paweł Przewięźlikowski 3 982 160 17,22% 7 482 160 27,54%
Bogusław Sieczkowski 825 348 3,57% 1 375 348 5,06%

**The beneficiary of Fundacja Rodzinna Rodziny Wesołowskich Fundacja Rodzinna w Krakowie is Mr. Tadeusz Wesołowski - Vice-Chairman of the Issuer's Supervisory Board.

Tadeusz Wesołowski (with Fundacja Rodzinna
Rodziny Wesołowski Fundacja Rodzinna w
Krakowie*)
1 372 713 5,94% 1 372 713 5,05%
Nationale Nederlanden OFE 1 389 036 6,01% 1 389 036 5,11%
Allianz Polska OFE 2 132 540 9,22% 2 132 540 7,85%
BioNTech SE 1 917 437 8,29% 1 917 437 7,06%

*The beneficiary of Fundacja Rodzinna Rodziny Wesołowskich Fundacja Rodzinna w Krakowie is Mr. Tadeusz Wesołowski - Vice-Chairman of the Issuer's Supervisory Board.

The above information on the state of possession of the Issuer's shares by shareholders (including those being members of the Company's bodies) holding directly and indirectly at least 5% of the total number of votes at the Company's General Meeting has been prepared on the basis of information obtained from shareholders through their performance of duties imposed on shareholders of public companies by virtue of relevant legal regulations, including on the basis of the provisions of the Act of 29. July 2005 on public offering and the conditions for introducing financial instruments to the organized trading system and on public companies (art. 69 and art. 69a) and on the basis of the provisions of the Regulation (EU) No 596/2014 of the European Parliament and of the Council of 16 April 2014 on market abuse and repealing Directive 2003/6/EC of the European Parliament and of the Council and Commission Directive 2003/124/EC, 2003/125/EC and 2004/72/EC (MAR Regulation, art. 19). In addition, information on the ownership of the Company's shares is provided on the basis of publicly available data on the portfolio exposure and asset structure of investment funds or pension funds, including information on the number of shares registered at the Company's General Meeting (data available periodically, inter alia, based on information from the financial statements of investment funds and pension funds - data may be subject to change since the date of publication of the last information).

5. STATEMENT OF THE MANAGEMENT BOARD REGARDING APPLICABLE ACCOUNTING PRINCIPLES

The management board of Ryvu Therapeutics S.A. confirms that, to the best of its knowledge, these quarterly financial statements of Ryvu Therapeutics S.A. and comparative data have been prepared in accordance with the applicable accounting principles and reflect in a true, fair and clear manner the Company's property and financial position and its financial result.

The report of the management board on the activities of Ryvu Therapeutics S.A. contains a true picture of the development, achievements and situation of the Company, including a description of the main threats and risks.

6. ADDITIONAL INFORMATION

Proceedings pending at court, before an arbitration institution or a public administration authority

The Company has filed a lawsuit against DUNA POLSKA S.A. (formerly: Mota-Engil Central Europe S.A.)  ("Contractor") to the Regional Court in Kraków concerning the construction of the Research and Development Center under the agreement for "Construction of the Research and Development Center of Innovative Drugs Selvita S.A." dated August 13, 2018 ("Construction Agreement"). The claims include the payment of contractual penalties for failure to meet the final deadline and intermediate deadlines, as well as for rectification or untimely reflection of defects related to the scope of the Construction Agreement, totalling PLN 13,756,717.07. The total value of the Construction Agreement was PLN 68.783.585,34,, including VAT. The proceedings are taking place before the District Court in Kraków in the first instance. On July 8, 2024, the Court concluded the oral hearings of witnesses and the Parties, simultaneously requiring the Parties to pay advances towards the expert's opinion (by July 22, 2024) and to inform the Court about the mutually agreed candidates for experts (by September 1, 2024). The Parties responded to the Court's request on the above-mentioned dates. The Parties responded to the Court's request within the above-mentioned deadlines. Subsequently, the Court requested the Parties to take a position on the offer of the expert selected by the Parties, who will prepare an opinion within the scope of the evidence outlined by the Parties. Both Parties accepted the offer. The files have been sent to an expert who will prepare an opinion based on the questions outlined by the Parties.

The Contractor has filed a lawsuit for payment against the Company to the Regional Court in Kraków in connection with the performance of the Construction Agreement for the project entitled: "Construction of the Research and Development Center for Innovative Drugs Selvita S.A." In the lawsuit, the Contractor is claiming damages for the costs incurred in connection with prolonged performance of the Construction Agreement, the unpaid portion of the lump sum fee as well as supplementary remuneration for additional, replacement and omitted works (PLN 5,391,425.63) as well as damages resulting from the Company's unauthorized - in the Contractor's opinion - application of the performance bond and removal of the defects and faults (PLN 2,063,507.56). With the statutory interests, the Contractor demands a total amount of PLN 7,671,285 from the Company. On 22 November 2023, the hearings of all witnesses and parties were completed. Subsequently, the files were forwarded to a court expert for the preparation of an opinion. On 8 April 2025, the expert's opinion was delivered to the Company, to which the Parties submitted objections in a procedural letter dated 30 May 2025. Currently, the Parties are awaiting the expert's response to the objections to the opinion submitted by the Parties.

Significant non-arm's length transactions with related entities

Not applicable.

Information on organizational or capital relations of the Issuer with other entities

As of the report's publication date, the Issuer does not form a Capital Group. As at the date of this Report, the Issuer holds 1,2% of shares in NodThera Inc.

Warranties for loans and borrowings and guarantees granted

Not applicable.

Other information significant for the assessment of the Issuer's position in the area of human resources, assets, cash flows, financial results and changes thereof and information significant for the assessment of the Issuer's ability to settle its liabilities

Not applicable.

Factors which, in the Issuer's opinion, will affect the results over at least the following quarter

The results of the subsequent quarters will depend primarily on the execution of the Company's strategy, which assumes, in particular, that the following business objectives will be met:

  • Expanding therapeutic potential of romaciclib (RVU120) by initiating and executing broad Phase II clinical development across multiple hematology indications and in diverse treatment settings (monotherapy and combination therapy);
  • Supporting clinical development of our partnered candidate, SEL24 (MEN1703) by Menarini Group;
  • Conducting preclinical development and advancing into Phase I clinical trials of one new program;
  • Strengthening of our Synthetic Lethality Platform and accelerating progress in the early pipeline;
  • Achieving financial milestones in the existing R&D collaborations (i.e. BioNTech, Exelixis, Menarini);
  • Signing at least one new partnering agreement per year.

Explanations regarding the seasonal or cyclical nature of the Issuer's operations in the reported period

Not applicable.

Information on inventory write-downs to the net realizable amount and reversal of such writedowns

Not applicable.

Information on impairment write-downs in respect of financial assets, tangible fixed assets, intangible assets or other assets and the reversal of such write-downs

Not applicable.

Information on the set-up, increase, utilization and reversal of provisions

Information on the changes in provisions for holidays and bonuses is provided in note 17 to the financial statements.

Information on deferred income tax provisions and assets

No significant changes.

Information on significant purchases or disposals of tangible fixed assets

No significant changes.

Information on significant liabilities in respect of purchases of tangible fixed assets

No significant changes.

Information on significant settlements resulting from court cases

Not applicable.

Error corrections relating to previous periods

Information is provided in note 15 to the financial statements.

Information on changes in the economic situation and business conditions, which have a significant effect on the fair value of the entity's financial assets and financial liabilities

Not applicable.

Information on the failure to repay a loan or borrowing or a breach of significant terms and conditions of a loan agreement, with respect to which no corrective action had been taken by the end of the reporting period

Not applicable.

Information on changes in the method of valuation of financial instruments measured at the fair value

Not applicable.

Information on changes in the classification of financial assets due to a change in their purpose

Not applicable.

Information on the issue, redemption and repayment of non-equity and equity securities

Not applicable.

Information on dividends paid (or declared) in the total amount and per share, divided into ordinary and preference shares

Not applicable.

Events that occurred after the date for which the quarterly financial statements were prepared, not disclosed in these financial statements although they may have a significant effect on the Issuer's future financial results

Not applicable.

Information on changes in contingent liabilities or contingent assets that occurred after the end of the last financial year

Information on changes in contingent liabilities or contingent assets is provided in note 22 to the financial statements.

Other disclosures which may have a material impact on the assessment of the Issuer's financial position and results of operations

Not applicable.

Amounts and types of items affecting the assets, liabilities, equity, net profit/ (loss) or cash flows,
which are unusual in terms of type, amount or frequency

Not applicable.

Dokument podpisany przez Paweł Tadeusz Przewięźlikowsk

i Data: 2025.11.19 11:48:45 CET

_______________________ Paweł Przewięźlikowski President of the Management Board

Dokument podpisany przez Krzysztof Daniel Brzózka Data: 2025.11.19 10:55:27 CET

_____________________ Krzysztof Brzózka Vice-President of the Management Board

Dokument podpisany przez Kamil Sebastian Sitarz Data: 2025.11.19 09:55:59 CET

_____________________ Kamil Sitarz Management Board Member

Digitally signed by Vatnak Vat-Ho Date: 2025.11.19 04:57:31 MST

_______________________ Vatnak Vat-Ho Management Board Member

_____________________ _______________________

Hendrik Nogai Justyna Żołtek Management Board Member Management Board Member

Elektronicznie podpisany przez Justyna Katarzyna Żółtek Data: 2025.11.19 12:24:49 +01'00'

CONTACT

RYVU THERAPEUTICS

2 Sternbacha Street 30-394 Krakow, Poland P: +48 12 314 02 00

GENERAL INQUIRIES

[email protected]

Talk to a Data Expert

Have a question? We'll get back to you promptly.