Oryzon’s stock closed the year significantly lower than it started. What do you think is due? What do investors need to trust your business model?
Stock prices have been affected by the general evolution of the economy, the fear of inflation and the consequences of the withdrawal of stimuli together with the news in the health field. The Omicron variant, which was detected in November, and the increasing rate of infections have affected the values in the market and Oryzon has not been an exception.
But the fundamentals of Oryzon have not changed and the news at the scientific level has been positive. It seems, however, that the market has recognized Oryzon’s potential in early 2022 and the stock has started to recover its valuation; At the beginning of the second fortnight of January, the value exceeded 3.20 euros and the trend should be positive and growing until reaching levels consistent with the situation of clinical trials that are underway.
What are the new objectives within the Oryzon Strategic Plan for this 2022?
Our strategic plan for 2022 is mainly based on advancing our drugs iadademstat for oncology and vafidemstat for diseases of the nervous system in trials that can lead to accelerated approvals by the International Medicines Agencies.
The 2021 financial year has been very positive for the company, with a succession of good news due to clinical advances. For this year we foresee new relevant progress. In this sense, with iadademstat we hope to report the final data of the ongoing Phase II trial in acute myeloid leukemia (AML) in December. In addition, with this same molecule we plan to start two new clinical trials in combination this year, in AML, the FRIDA trial, and in solid tumors, the STELLAR trial, which we believe could support applications for accelerated marketing approval if favorable results are obtained.
With vafidemstat we have two Phase IIb trials underway in Borderline Personality Disorder (BPD) and in schizophrenia. In addition, we are deploying a radically innovative approach to precision medicine as a result of the independent work of the scientific community showing that LSD1 inhibitors such as vafidemstat compensate for the effects of a series of genetic faults that occur in certain neurodevelopmental syndromes, such as Syndrome of Kabuki (SK) and others. In collaboration with the world leaders in this syndrome, we have prepared a Phase I/II clinical trial in patients with KS, with the potential for accelerated approval in the US, and we have several additional collaborations under way in the field of medicine of precision in Spain and the USA.
How is the line of inorganic growth raised?
If we see opportunities for acquisitions or mergers that create a qualitative leap in the value proposition or clear synergies, we will act accordingly, but we do not want to lose our focus as epigenetic drug leaders.
How is Oryzon’s presence evolving in the US market?
Oryzon maintains an increasingly prominent presence in the US We have just hired Dr. Ana Limón as Senior Vice President of Clinical Development and Medical Affairs. Her extensive scientific and clinical research experience in hematology and oncology will be key to the development of Oryzon’s clinical programs. In addition, last November we incorporated a new Global Business Director, Dr. Saikat Nandi, who is endorsed by significant experience in the US capital markets and who will allow us to intensify our contacts with Wall Street and with pharmaceutical companies. to explore alliances. Both appointments reinforce Oryzon’s continued presence in the United States at a time when the company is building strategic collaborations with US hospitals and research institutions to develop its pipeline and clinical programs. We hope to extend our presence with future additions.
ALICE, FRIDA or PORTICO are some of the essays developed by Oryzon. Will they continue to maintain the high rate of investment in R&D with a view to new projects? What progress do you expect to make throughout the year?
Our business model is based on clinical advances, therefore, it is necessary to continue maintaining the high rate of investment. In 2022 we have received authorization from the Serbian Medicines Agency to carry out the Serbian arm of our Phase IIb clinical study PORTICO with vafidemstat in patients with BPD. Thus, we culminate the deployment of PORTICO, in Europe and in the US, where we will soon have 16 Hospitals recruiting. We hope to be able to carry out the interim analysis at the end of 2022 with the results of the first 90 completed patients. Also in 2022, we will start the first precision medicine clinical trial in the CNS with vafidemstat, in SK (HOPE trial).
Iadademstat will complete the Phase II clinical trial (ALICE) in AML in combination with azacitidine and we plan to present the final ALICE data at ASH2022 in December. We will roll out FRIDA, a Phase Ib/II trial in combination with gilteritinib in patients with FLT3-mutated AML who are refractory or have relapsed, an unmet clinical need and an important market niche. Xospata®, the drug that will accompany our treatment in the combination, has peak sales forecasts by analysts of +$600m, which gives an idea of the potential of this market segment and of our molecule. In small cell lung cancer, the STELLAR trial, a Phase Ib/II trial combining iadademstat with an immune checkpoint inhibitor in first-line metastatic patients, and the basket trial in neuroendocrine tumors will complete activity in solid tumors .
