On September 8, 2021 Ryvu Therapeutics (WSE: RVU) reported its 2021 semiannual financial results and provided a corporate update (Press release, Ryvu Therapeutics, SEP 8, 2021, View Source [SID1234587441]).
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"The first half of 2021 was a time to remember for Ryvu. After some initial setbacks we reported major developments in our both clinical programs confirming single agent efficacy of RVU120 and SEL24/MEN1703, and we entered H2 2021 with a solid foundation for the further advancement of our pipeline" – commented Pawel Przewiezlikowski, Chief Executive Officer of Ryvu.
"In April 2021 the FDA placed a partial clinical hold on our Phase Ib clinical trial of RVU120 in AML/HR-MDS patients which was then successfully lifted in July. We also received a full approval to initiate Phase I/II trial with RVU120 in solid tumors, and the first patient has been already dosed in that trial. EHA (Free EHA Whitepaper) 2021 Congress was an exceptional one for us, as we got to present the first positive Phase I data for RVU120, along with the positive follow-up Phase II data presented for SEL24/MEN1703 by our partner, Menarini. We also enjoyed the first ever oral presentation of RVU120 at a major oncology conference, demonstrating its potential in promoting cell differentiation. Additionally, we welcomed Vatnak Vat-Ho, our new Chief Business Officer, on board" – adds Przewiezlikowski.
Recent Achievements
First patient dosed in Phase I/II study of RVU120 (SEL120) in patients with relapsed/refractory (R/R) metastatic or advanced solid tumors
On August 25, Ryvu announced that the first patient was dosed in the Phase I/II clinical trial investigating RVU120 in relapsed/refractory metastatic or advanced solid tumors. The single-agent, open-label Phase I/II trial is currently enrolling patients in Poland, and site expansion to Spain is in progress.
Initial positive clinical data presented at the EHA (Free EHA Whitepaper) Virtual Congress in June 2021; RVU120 Phase Ib study in AML and high-risk MDS patients resumed enrollment;
The initial safety and efficacy data from the first four cohorts in the trial were presented at the Virtual EHA (Free EHA Whitepaper) Congress on June 11, 2021. RVU120 demonstrated acceptable safety profile and two clinically relevant responses were observed in the first five AML and high-risk MDS patients treated: one complete response (CR) and one erythroid response. During the partial clinical hold, two patients continued on RVU120 treatment, and one MDS patients currently remains on study after more than 12 months of treatment with RVU120.
On July 14, Ryvu announced that the U.S. Food and Drug Administration lifted a partial clinical hold, previously announced on April 8, 2021, on the first-in-human (FIH) Phase Ib, dose escalation clinical trial of RVU120 in patients with R/R acute myeloid leukemia (AML) and high-risk myelodysplastic syndrome (high-risk MDS), being conducted in the United States.
Positive Phase I/II data for SEL24 (MEN1703) presented by development partner Menarini at EHA (Free EHA Whitepaper) 2021
A clinical poster on the first-in-human study of SEL24/MEN1703, the DIAMOND-01 trial conducted by Ryvu’s partner Menarini Group, reported four objective responses across the dose escalation (n=25) and cohort expansion (n=23) in patients with AML. Three out of five AML patients harboring IDH mutations treated at 75-125 mg achieved CR/CRi. A follow-up study in IDH-mutated patients was initiated by Menarini in July 2021.
Synthetic lethality platform highlighted in investor event: WRN, PRMT5 and novel targets advancing in the pipeline
On June 09, Ryvu held a live webinar called "Synthetic lethality in cancer treatment" with leading researchers in the field. The webinar targeted the Polish investor community and was well attended. Highlights of the webinar included Ryvu’s WRN/MSI-high and PRMT5/MTAP-deletion programs, as well as an overview of Ryvu’s discovery pipeline including novel synthetic lethality targets.
Publication of research on MCT4 inhibitors in the Journal of Medicinal Chemistry
On August 08, a joint publication of researchers from Ryvu Therapeutics and Merck KGaA on the discovery, development, and optimization of selective MCT4 inhibitors was published in the "Journal of Medicinal Chemistry": "Discovery of 5-{2-[5-Chloro-2-(5-ethoxyquinoline-8-sulfonamido)phenyl]ethynyl}-4-methoxypyridine-2-carboxylic Acid, a Highly Selective in Vivo Useable Chemical Probe to Dissect MCT4 Biology."
Ryvu is scheduled to participate in the following upcoming investor conferences:
Morgan Stanley 19th Annual Global Healthcare Conference on Thursday, September 9, 2021 – Wednesday, September 15, 2021. Ryvu will participate in a fireside chat on Friday, September 10 at 2:45 PM (ET), and host investor meetings during the conference.
H.C. Wainwright 23rd Annual Global Investment Conference, on Monday, September 13 – Wednesday, September 15, 2021. Ryvu’s corporate presentation will be available on-demand starting on September 13 at 7:00 AM (ET), and Ryvu will host investor meetings during the conference.
Ryvu 2021 Half Year, Financial Results
In the first Half Year of 2021, the Company reported PLN 12.2 million (USD 3.2 million) of revenues. Over 90% of the revenues were grants (PLN 11.3 million or USD 3.0 million) and the remainder consisted of income from partnering (PLN 0.4 million or $0.1 million), other revenues (PLN 0.3 million or USD 0.1 million) and other operating revenues in total PLN 0.2 million (USD 0.04 million).
Operating costs, excluding the non-cash cost of valuation of the Incentive Program (PLN 6.7 million or USD 1.8), in the audited period amounted to PLN 43.5 million (USD 11.5 million), and related in majority to research and development expenditures, while the operational loss without Incentive Program was PLN 31.3 million (USD 8.3 million) compared to PLN 11.8 million (USD 3.0 million) reported in the corresponding period in 2020. Net loss without Incentive Program for the first Half Year of 2021 amounted to PLN 30.9 million (USD 8.2 million) and the reported loss for the corresponding period of 2020 amounted to PLN 8.6 million (USD 2.1 million).
The results are consistent with the strategy assumptions of Ryvu Therapeutics. The company remains focused on increasing the value of its projects which are intended to be commercialised at later stages of the development cycle and generate substantial financial surpluses.
On August 31, 2021, Ryvu Therapeutics held PLN 96.4 million (USD 25.4 million) in cash, cash equivalents, and short-term investments.