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- The key goals for Ryvu’s pipeline in 2022-2024: broad development of RVU120 (including potential fast-to-market strategy in AML/HR-MDS), advancement of one preclinical program into Phase I clinical trials, strengthening of Synthetic Lethality Platform, and acceleration in the early pipeline, achieving milestones in existing collaborations (i.e. Menarini, Galapagos, Exelixis) and execution of at least one new partnering deal per year;
- The financing of these Development Plans is planned from Company’s cash, recently announced venture debt from the European Investment Bank (EIB), existing and new grants, milestones from the current collaborations, new partnering deals, and additional sources, including equity capital markets;
- The Company announced a General Shareholders Meeting for September 19th, 2022, to obtain approval of the Authorized Capital (up to 8,465,615 shares), which would provide flexibility to optimize the timing and amount of equity capital financing through 2024;
- Ryvu announced a special, open webcast with regard to its Development Plans for Monday, August 22nd, at 9:00 AM CEST. Link to the registration is available HERE.
Ryvu Therapeutics S.A. (WSE:RVU), a clinical-stage drug discovery and development company focusing on novel small molecule therapies that address emerging targets in oncology, announced its Development Plans for 2022-2024. Key development goals are divided into three areas:
1. Clinical Development Pipeline:
a) Completing the ongoing Phase I clinical studies of Ryvu’s fully-owned lead asset RVU120 in:
i. acute myeloid leukemia (AML) and high-risk myelodysplastic syndrome (HR-MDS);
ii. solid tumors;
b) Advancing the clinical development of RVU120 as a monotherapy, by executing Phase II studies in:
i. hematology – with a potential fast-to-market strategy in AML/HR-MDS;
ii. selected solid tumor indications – with a primary focus on triple-negative breast cancer (TNBC);
c) Expanding the therapeutic potential of RVU120 by initiating Phase I/II clinical development in:
i. combination regimens in AML/HR-MDS with synergistic drug partners;
ii. additional hematology indications (e.g. low-risk myelodysplastic syndrome (LR-MDS) and MDS/MPN overlap syndrome) and solid tumor indications (e.g. metastatic castration-resistant prostate cancer (mCRPC) or sarcomas);
d) Supporting the clinical development of the partnered candidate, SEL24 (MEN1703) by Menarini Group;
2. Early Pipeline (Discovery and Preclinical Development):
a) Completing preclinical development and advancing into Phase I clinical trials of one program from Ryvu’s early pipeline;
b) Strengthening Ryvu’s Synthetic Lethality Platform to deliver first-in-class preclinical candidates and further expand the proprietary target discovery platform;
3. Business:
a) Achieving financial milestones in the existing R&D collaborations;
b) Advancing selected programs by partnering with collaborators with synergistic competencies and resources, signing at least one new partnering agreement per year.
– Our plans for 2022-2024 are focused on accelerating the execution of Ryvu’s mission, which is discovering and developing drugs that will improve the lives of cancer patients and their families. We are also aiming to maximize the value of the Company for our Shareholders. We intend to start a broad Phase II program for RVU120 – our lead asset in Phase I in AML/HR-MDS and solid tumors – including the potential fast-to-market strategy, as well as significantly accelerate our efforts in the early pipeline, especially in the area of Synthetic Lethality – said Pawel Przewiezlikowski, Ryvu’s co-founder, the largest shareholder, and the CEO.
The total budget for 2022-2024 Development Plans is estimated at USD 115m*, out of which approximately USD 64m will be dedicated to clinical development (development of RVU120 and initiation of Phase I study for one new candidate from the early pipeline); approximately USD 37m is planned for the development of early pipeline (including further strengthening of the Synthetic Lethality Platform); approximately USD 14m is planned to cover G&A costs.
The financing for the execution of Development Plans for 2022-2024 is planned to be secured from the existing cash (USD 9.6m**), venture debt from EIB (EUR 22.0m), committed partnering milestone payments, and currently secured grants (USD 10.6m) as well as assumed future grants (USD 6.5m), and various sources including equity capital markets, potential milestones from existing collaborations, new partnering deals, additional grant funding and other sources (USD 66.1m).
– We are securing capital for the pipeline development from various sources, and we are targeting to sign at least one new partnering deal per year. At the same time, we have developed several alternative scenarios to de-risk portfolio investments, for example in the case of broad development for RVU120 – said Pawel Przewiezlikowski.
Together with the Development Plans for 2022-2024, Ryvu announced its General Shareholders Meeting with an intention to obtain approval of the Authorized Capital (up to 8,465,615 shares, which will constitute up to 32% of the total number of shares in case of full execution) of the Company, which would provide flexibility to optimize the timing and amount of equity capital financing through 2024.
– We aim to accelerate our development to maximize the value of the Company for its Shareholders, but we also want to reduce their risk and minimize the share dilution. We think that Authorized Capital is a perfect tool to support these goals on the way to executing the current Company’s plans. At first, we aim to issue an optimal number of shares by the end of 1Q 2023. In parallel, we will seek to obtain additional financing from additional sources to reduce Ryvu’s equity capital needs. Authorized Capital will support our financing flexibility and strengthen our business position – said Pawel Przewiezlikowski.
More on RVU120
RVU120 (SEL120) is a clinical-stage, highly specific, and orally bioavailable dual inhibitor of CDK8/CDK19 kinases, which has demonstrated efficacy in a number of solid tumor in vitro and in vivo models as well as in hematologic malignancies. Clinical benefit has been demonstrated in patients with AML or HR-MDS: a complete remission (CR) in a DNMT3A/NPM1-mutated AML patient; more than 18 months’ duration of treatment in a DNMT3A-mutated high-risk MDS patient; stable diseases (SD) with blast reductions in three additional patients (data presented at European Hematology Association Congress, June 2022).
At present, Ryvu is conducting two clinical studies with RVU120: (i) Phase Ib in patients
with AML/HR-MDS (additional Phase I data expected in 4Q 2022) and (ii) Phase I/II in relapsed/refractory metastatic or advanced solid tumors (new Phase I data expected in 4Q 2022).
RVU120 has been internally discovered by Ryvu and has received prestigious support from the Leukemia & Lymphoma Society Therapy Acceleration Program® (TAP). On March 25, 2020, the U.S. Food and Drug Administration (FDA) granted an orphan drug designation (ODD) to RVU120, for the treatment of patients with AML.
More on Synthetic Lethality Platform
Ryvu is currently leading multiple initiatives in the area of Synthetic Lethality, focused on the identification and validation of novel targets for well-defined patient populations. Key criteria for prioritized targets are first-in-class and best-in-class potential. Several targets have already been identified. By the end of 2024, Ryvu intends to further expand its platform’s capabilities to build a robust portfolio of projects aiming at the identification of first-in-class, differentiated lead, and preclinical candidate molecules. Primary therapeutic indications in our focus are subsets of lung, colorectal, breast, ovarian, and kidney cancers, as well as hematology.
The most advanced program from the Synthetic Lethality Platform that could enter clinical development is a synthetic lethal PRMT5 inhibitor, targeting MTAP deficient cancers. Deletion of the metabolic gene MTAP occurs in 10% to 15% of all human tumors and represents a large unmet medical need. The rapid development of the PRMT5 program over the past year has built the foundation for the possible identification of a preclinical candidate by mid-2023, followed by an IND (Investigational New Drug) filing by mid-2024 and the initiation of Phase I studies in 2H 2024. The most likely first therapeutic indication for the clinical development of the PRMT5 program will be MTAP-deleted non-small-cell lung carcinoma (NSCLC), with further potential for a tumor-agnostic label and a fast-to-market track in orphan indications.
Another advanced project – focused on WRN inhibitors – is currently at the hit-to-lead stage. The primary therapeutic areas for Ryvu’s WRN inhibitor program are MSI-high cancers, with colorectal carcinoma as the potential first indication.
* additional cash buffer is not recognized as a budget item, the Company includes an additional USD 11m to the financial plan, to secure the cash position (proportional to the current cash balance) at the end of the forecasted period.
** as of June 30, 2022.
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