Continued Progress, Promise With Oryzon's Pipeline

Last week, Oryzon Genomics (MADX: ORY) reported financial results and provided a corporate update following the end of the first quarter 2017. The company made a number of advancements during the first quarter, including successfully completing a Phase 1/2a clinical trial with ORY-1001 in acute leukemia. Preliminary data was presented at the American Society of Hematology (ASH) meeting in December 2016. With the final data now analyzed, Oryzon has passed off future development of ORY-1001 to commercial partner, Roche.

Oryzon also presented preliminary Phase 1 data from ORY-2001 at the 13th International Conference on Alzheimer's and Parkinson's Disease. The positive safety and pharmacologic data, along with confirmed proof-of-concept, positions Oryzon to move into Phase 2 studies later this year. Finally, pre-IND work on ORY-3001 continues, with the goal to file later in 2017.

Oryzon also raised €18 million in cash during the first quarter through a private placement with U.S. and European investors. As a result, the company exited the quarter with $29.8 million in cash and marketable securities. The solid cash position is sufficient to fund Oryzon for the foreseeable future. Below is a detailed update on the pipeline for investors.

Quick Review of the Financials

On May 9, 2017, Oryzon reported financial results for the first quarter 2017. Total collaborative revenue for the quarter was $0.02 million. Revenue is derived from collaborative research work with Roche on ORY-1001, deferred recognition of a previous upfront payment from Roche for ORY-1001 in 2014, and non-dilutive research grants that support work on ORY-2001.

Research grants have been a nice source of cash for the company. In December 2016, Oryzon announced a new grant in the form of a loan from the Ministry of Economy and Competitiveness, Government of Spain and FEDER Funds from the European Union and included under the RETOS Collaboration 2016 program. Oryzon will receive approximately $0.8 million through multiyear disbursements for further development of its epigenetic inhibitors against inflammatory indications.

In April 2017, the company announced another grant from the Alzheimer's Drug Discovery Foundation (ADDF) of $0.3 million. The grant will help fund the clinical development of a companion market for the treatment of AD with Oryzon's dual LSD1/MAO-B inhibitor, ORY-2001. ADDF is also a shareholder in Oryzon, owning just under 1% of the common stock.

Net loss for the quarter totaled $1.4 million, driven by $1.6 million in R&D and $1.0 million in general and administrative costs. Oryzon continues to invest in its therapeutic pipeline, having recently reported positive data on the multiple ascending dose part of the ORY-2001 Phase 1 study and nominated ORY-3001 for IND-enabling studies in non-oncological conditions. Nevertheless, the solid cash position of $29.2 million, recently strengthened by the €18.2 million private placement, is sufficient to fund operations well into 2018. The private placement took place at €3.20 per share; this is roughly where the shares are trading today (€3.30).

Pipeline Update - RG6016 (formerly ORY-1001)

Roche is now solely responsible for the development of ORY-1001 (now called RG6016). I think Oryzon did a fantastic job in stewarding development of ORY-1001, the company's potent and highly selective LSD1 inhibitor, from preclinical studies through the Phase 1/2a program. The Phase 1/2a data presented at the ASH demonstrate excellent safety and tolerability, along with initial signs of therapeutic effect in acute leukemia.

For example, in vivo blast differentiation (including differentiation syndrome) occurred in four of six (67%) subjects with MLL fusion gene. Falling bone marrow blasts was observed in one subject following subsequent cycles. Blast cells cleared from blood in another subject that achieved stable disease. In subjects with M6/AML, all achieved stable disease (n=4). Results in other subjects (n=4) with MLL were mixed, with one achieving differentiation and another showing only residual skin disease, whereas one saw progressive disease and another was unevaluable (withdrew).

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