ORYZON Q1 2024 Financial Results and Corporate Update

ORYZON Genomics, a clinical-stage biopharmaceutical company, recently shared its financial results for the first quarter of 2024 and provided updates on its ongoing clinical programs.

The company reported research and development (R&D) expenses of $2.6 million for the quarter ending March 31, 2024, a significant decrease from the $4.4 million spent during the same period in 2023. This reduction was attributed to the completion of the PORTICO clinical trial. General and administrative expenses also decreased, totaling $0.9 million compared to $1.2 million in the previous year. Overall, net losses narrowed to $1.1 million from $1.4 million year-over-year.

Oryzon's CEO, Dr. Carlos Buesa, highlighted advancements in the company's clinical programs. In the Central Nervous System (CNS) area, the company is finalizing the full data analysis from its Phase IIb PORTICO trial, which evaluated vafidemstat for Borderline Personality Disorder (BPD). The company plans to request an End-of-Phase II meeting with the FDA to discuss a Phase III trial. Additionally, Oryzon received an "intention to grant" patent from the European Patent Office for the use of vafidemstat to treat aggression and social withdrawal, enhancing its intellectual property position.

In oncology, the iadademstat program made significant strides. The FRIDA trial, which combines iadademstat with gilteritinib for relapsed/refractory FLT3-mutant Acute Myeloid Leukemia (AML) patients, has completed its second cohort and is recruiting for the third. Preliminary data appear promising, and further details will be shared at the EHA Conference in Madrid. Additionally, a Phase I/II trial of iadademstat plus immune checkpoint inhibitors for extensive-stage Small Cell Lung Cancer (SCLC) has received FDA approval, and patient enrollment is expected to begin soon.

Moreover, Oryzon continues to explore the minimal effective dose of iadademstat in combination with gilteritinib under the FDA’s OPTIMUS doctrine. The company is also expanding its clinical development of iadademstat in AML through an Investigator-Initiated Study (IIS) led by Oregon Health & Science University. This study will evaluate iadademstat in combination with venetoclax and azacitidine in first-line AML patients and is expected to start recruiting in the second quarter of 2024.

The collaborative Phase II basket trial of iadademstat in combination with paclitaxel for relapsed/refractory small cell lung cancer (SCLC) and high-grade neuroendocrine tumors continues patient enrollment. This trial is conducted under a collaborative agreement with Fox Chase Cancer Center, where Oryzon provides funding and technical expertise.

In terms of financial health, Oryzon reported a decrease in net losses to $1.1 million for the first quarter of 2024, compared to $1.4 million during the same period in 2023. The company's cash, cash equivalents, and marketable securities stood at $11.6 million as of March 31, 2024, down from $13.5 million at the end of 2023.

Founded in 2000, Oryzon is a leader in epigenetics with a focus on personalized medicine for CNS disorders and oncology. The company’s clinical pipeline includes vafidemstat for CNS diseases and iadademstat for cancer, both in various stages of clinical trials. Additionally, Oryzon is advancing ORY-4001, a selective HDAC6 inhibitor, for neurological diseases like Charcot-Marie-Tooth disease and Amyotrophic Lateral Sclerosis.

Overall, Oryzon is making notable progress in both its CNS and oncology programs while maintaining financial discipline and advancing its clinical pipeline towards pivotal trials and potential market approvals.