Ryvu Therapeutics Summarizes 2023 Fiscal Year and Provides Corporate Update
-
Total operating revenues for the full year 2023 were
$16.3M , compared to$15.8M for the same period in 2022. -
As of
March 7, 2024 , Ryvu's cash position was$57.2M , excluding the first tranche of €8M in venture debt from the EIB, expected imminently. Together with other already secured funding sources, this cash position provides a runway through Q1 2026. -
Ryvu will present preclinical data from its synthetic lethality pipeline, RVU120, and MEN1703 (SEL24) at the upcoming 2024
American Association for Cancer Research (AACR) Annual Meeting (April 5-10 ,San Diego, California ). - After announcing the hematology-focused RVU120 development plan in Q4 2023, Ryvu launched two Phase II studies in early 2024. An additional two Phase II clinical trials for RVU120 are expected to be launched in mid-2024. By the end of the year, the company plans to enroll over 100 patients across all RVU120 Phase II studies and aims to present initial Phase II data.
KRAKOW,
Pawel Przewiezlikowski, co-founder, largest shareholder, and Chief Executive Officer of
- In 2023, we made significant progress in all key business areas and look forward to multiple catalysts in 2024. We have already started two Phase II studies of RVU120, and around mid-year, we plan to launch two more Phase II studies in hematology. By the end of the year, we plan to enroll more than 100 patients across these clinical trials. We also plan to launch a new Phase II study of MEN1703 (SEL24) in DLBCL, which is being developed under a license agreement with the
- We are pleased with the significant progress made in our early-phase projects. Among the most advanced projects from our synthetic lethality platform – PRMT5 and WRN – we plan to identify a clinical candidate in 2024. We are also seeing progress in the programs being developed by our partners – particularly BioNTech and Exelixis. We were excited to achieve the second milestone in the Exelixis collaboration, and we look forward to presenting data on our synthetic lethality assets and novel platform at AACR.
2023 SUMMARY AND RECENT CORPORATE EVENTS
RVU120 clinical development plan
- In 2023 Ryvu prepared for the launch of two Phase II RVU120 trials, which then initiated in early 2024: 1) RVU120 as monotherapy in genetically defined cohorts of patients with relapsed/refractory acute myeloid leukemia (r/r AML) and high-risk myelodysplastic syndromes (HR-MDS, RIVER-52 study), and 2) RVU120 in combination with venetoclax for patients with relapsed/ refractory AML (RIVER-81 study).
- Ryvu will financially support the REMARK study's Phase II clinical trial of RVU120 in patients with low-risk myelodysplastic syndromes (LR-MDS). REMARK will be conducted as an investigator-initiated study through the
EMSCO network, with Prof.Uwe Platzbecker , a globally renowned expert in the field of LR-MDS, as the Coordinating Principal Investigator. Start-up activities have already been launched, and patient enrollment will start in mid-2024. - Study start-up is also underway for POTAMI-61, a Phase II study evaluating the efficacy of RVU120 in patients with myelofibrosis (MF). Initiation of patient recruitment is scheduled for mid-2024.
- Translational research on RVU120 in solid tumors will continue, including combination studies, as well as academic collaborations in the areas of medulloblastoma (MB) and sarcoma-related research.
- The company plans to enroll more than 100 patients across all RVU120 Phase II trials this year and aims to present initial Phase II data by the end of 2024.
- RVU120's updated clinical development plan includes studies (RIVER-52, RIVER-81, and POTAMI-61) that could lead to three drug approvals between 2026 and 2027.
Key data presented during 2023 conferences
In 2023,
- RVU120 monotherapy demonstrated clinical activity in a Phase Ib study in which 50% of evaluable patients with r/r AML or HR-MDS achieved clinical benefit, including a complete response, morphologically leukemia-free status, clinically significant reduction of blasts including reductions that allowed bridging to a bone marrow transplantation, two-year disease stabilization, hematologic improvements, as well as reduction in bone marrow fibrosis.
- In particular, early signs of efficacy were observed in patients with an NPM1 mutation, DNMT3a mutation, and HR-MDS.
- The recommended Phase II dose (RP2D) of 250 mg was found to be safe and well-tolerated, achieving RVU120 concentrations in the pharmacologically active range, with a level of target inhibition between 50% and 70%. This level of target inhibition is expected to result in therapeutic efficacy in selected patients or in combinations with synergistic therapies.
- RVU120 is emerging as a potential candidate in the first-line treatment of AML, supported by its activity against leukemic stem cells.
- RVU120 acts synergistically with venetoclax in both sensitive and venetoclax-resistant models.
At the ENA conference in
- Ryvu has developed potentially best-in-class MTA-cooperative PRMT5 inhibitors with outstanding drug-like physicochemical properties and the ability to block methyltransferase activity of PRMT5 with nanomolar concentrations and bioavailable upon oral administration. The novel, optimized inhibitors exhibit a significantly improved pharmacokinetic profile. In addition, the compounds show antitumor efficacy and target engagement in vivo, providing a solid foundation for further development towards clinical trials.
- MEN1703 (SEL24) has shown promising antitumor activity in translational studies in various types of DLBCL. These data justify the development of MEN1703 in Phase II clinical trials in this indication.
Expansion of MEN1703 (SEL24) development by Ryvu's partner –
In
- A Phase II study in DLBCL is scheduled to begin in mid-2024. The goal is to evaluate the activity of MEN1703 (SEL24) as monotherapy and in combination with standard therapy in patients with DLBCL.
- The study will be initiated based on the potent activity of MEN1703 (SEL24) observed in preclinical lymphoma models. Clinical trials have confirmed the acceptable safety profile and early signs of activity of MEN1703 (SEL24) as a monotherapy. Based on the available data, further program development will continue in patients with DLBCL and potentially in additional indications.
Recent financial events
- On
February 3, 2024 , Ryvu received notice that the second financial milestone was achieved under the collaboration agreement with Exelixis, resulting in a$2M payment to Ryvu. Ryvu and Exelixis are working under a research collaboration and license agreement to develop antibody-drug conjugates (ADCs) with Ryvu's portfolio ofSTING agonists. - On
March 5, 2024 , Ryvu received notice from theEuropean Investment Bank (EIB) that it had met the conditions for disbursement of the first venture debt tranche of €8M. These funds are not yet included in the cash balance reported in this press release, but Ryvu expects to receive the funds onMarch 13, 2024 . As part of the agreement announced inAugust 2022 , Ryvu still has access to an additional €14M in venture debt from the EIB.
UPCOMING EVENTS
- Ryvu will attend the AACR Annual Meeting (
San Diego, USA ) fromApril 5-10, 2024 , to present preclinical data from its synthetic lethality pipeline, RVU120, and MEN1703 (SEL24).
2023 Fiscal Year Financial Update[1]
Cash Position – On
Operating Revenues – In 2023, Ryvu recognized total operating revenues (including grants) of
Operating costs, excluding the non-cash cost of valuation of the Incentive Program (
Net Loss Attributable to Common Shareholders – In 2023, the net loss attributable to common shareholders, excluding the non-cash cost of valuation of the Incentive Program, amounted to
About Ryvu Therapeutics
Ryvu's most advanced programs include RVU120, a selective CDK8/CDK19 kinase inhibitor with the potential to treat hematological malignancies and solid tumors, currently in Phase II development (i) as a monotherapy for the treatment of patients with relapsed/refractory acute myeloid leukemia (r/r AML) and high-risk myelodysplastic syndromes (HR-MDS) as well as (ii) in combination with venetoclax for the treatment of patients with r/r AML. Another clinical program, SEL24 (MEN1703), is a dual PIM/FLT3 kinase inhibitor licensed to the
The Company was founded in 2007 and is headquartered in Kraków,
For more information, please see www.ryvu.com.
[1] USD figures are provided at a conversion rate of:
- for the period from
01/01/2023 – 31/12/2023: PLN 4.1823; - for the period from
01/01/2022 – 31/12/2022: PLN 4.4679; - as of 7/03/2024: PLN 3.9485
- as of 31/12/2023: PLN 3.9350
- as of 31/12/2022: PLN 4.4018
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