OncoArendi Therapeutics Reports Continued Strategic and Operational Momentum for 12 Months ended 31 December 2021

- Significant partnership agreement with the world-renowned International Institute of Molecular and Cell Biology in Warsaw (IIMCB) to accelerate the strategic development of OncoArendi’s small molecule RNA platform

- Novel dual acting first-in-class arginase inhibitor OATD-02 scheduled to begin Phase 1/2 clinical trials in 2022 

Warsaw, Poland, 25 March 2022 – OncoArendi Therapeutics S.A. (”OncoArendi”; WSE: OAT), a clinical stage biopharmaceutical company that uses its world leading medicinal chemistry capabilities to discover and develop first-in-class small molecule drug candidates that directly modulate RNA and unexplored protein targets to treat multiple incurable diseases, provides an update on operational activities and reports its consolidated results for the 12 months ended 31 December 2021. The full report in Polish can be found here

Marcin Szumowski, CEO and President of the Management Board of OncoArendi commented: “We have made excellent progress during 2021 on key strategic initiatives including establishing a significant partnership agreement with the world-renowned International Institute of Molecular and Cell Biology in Warsaw (IIMCB) to accelerate the development of our small molecule RNA targeting discovery platform. We have also successfully completed preclinical development of our novel dual acting first-in-class arginase inhibitor OATD-02, which is scheduled to begin Phase 1/2 clinical trials in 2022 for patients with different types of cancer, further validating our world leading medicinal capabilities and translational expertise.

Our progress in 2021, followed a key success in late 2020 when we signed an exclusive license agreement with Galapagos for the global development and commercialization of OATD-01 (now GLPG4716). Galapagos is planning the further clinical development as it prepares to advance GLPG4716 into Phase 2, which could generate significant revenues over the coming years if milestones are reached successfully.

Our strong balance sheet supports our ability to drive our organic, in-licensing and partnering opportunities that complement our existing expertise and could allow further value to be realized from our small molecule programmes and RNA discovery platform in the future. Further, the planned leadership changes announced recently are aimed at bringing new insights and drive to the Company as we evolve towards our goal of becoming a leading global biopharmaceutical company developing lifesaving therapies for people around the world.

We continue to be guided by our expertise in medicinal chemistry and biology of inflammatory disease and cancer to generate best-in-class treatments and look forward to achieving upcoming milestones across our portfolio in 2022.”

Operational highlights for 2021

• New strategic collaboration and licensing agreement with the world-renowned International Institute of Molecular and Cell Biology in Warsaw (IIMCB) accelerates the Company’s development of small molecule drug candidates that directly modulate mRNA function
• Successful completion of preclinical development of OATD-02, a first-in-class dual acting arginase inhibitor for the treatment of cancer, due to start First-In-Human Phase 1/2 in the second half of 2022
• Initiated 2 new drug discovery programs to add to the existing chitinase and deubiquitinase inhibitor platforms:

o    A selective CHIT1 inhibitor for the treatment of non-alcoholic steatohepatitis (NASH) and potentially a spectrum of neuroinflammatory diseases

o    USP, a ubiquitin-specific protease, a promising therapeutic target for the treatment of cancer

• Galapagos initiated a series of drug-drug interaction studies with OATD-01/GLPG4716 ahead of starting a planned Phase 2 study.

Important Post-period Highlights

• New license option agreement with University of Michigan to develop small molecule leads against a novel target for the treatment of fibrotic diseases

Key organizational changes to drive the Company through its next phase of evolution

• Internal team members appointed to the Management Board: Dr. Adam Gołębiowski, Dr. Zbigniew Zasłona and Agnieszka Rajczuk-Szczepańska
• Appointment of Samson Fung, M.D., PhD, as Chief Medical Officer.
• Supervisory board expanded to include Nancy Van Osselaer, Paul van der Horst and Rafal Kamiński as its new members

Financial Highlights for the 12-month Period ended 31 December 2021

• Operating income totalled PLN1.46 million (US$335,800), a decrease of PLN123.45 million (US$28.39 million). This was due to an upfront payment of US$28 million being received in 2020 from the deal with Galapagos.
• Operating expenses totalled PLN15.22 million (US$3.50 million), a decrease of PLN35.99 million (US$8.28 million) from 2020. This was due to transaction costs and R&D expenses associated with the Galapagos deal signed in 2020. 
• Net loss for the 12-months ended 31 December 2021 totalled PLN13.64 million (US$3.13 million). In 2020 the company made a profit of PLN64.27 million (US$14.78 million) due to the upfront payment from the Galapagos deal.
• As of December 31, 2021, OncoArendi had cash of PLN102m (US$23.46 million)
• Current funds are expected to fund the company’s operating expenses and capital expenditure requirements into the 4th quarter of 2023.

US$/PLN exchange rate 4.35

About OncoArendi

OncoArendi is a clinical stage biopharmaceutical company that uses its world leading medicinal chemistry capabilities to discover and develop first in class small molecule drug candidates that directly modulate RNA and underexplored protein targets to treat multiple incurable diseases.

OncoArendi has generated a diverse pipeline of nine distinct programs with the support of leading academic life science institutions globally, including the International Institute of Molecular and Cell Biology in Warsaw (IIMCB), which has significant expertise in RNA science.

OncoArendi’s most advanced in-house compound is OATD-02, an oral, potent and selective first in class, dual arginase inhibitor (ARG1 and ARG2) for the treatment of cancer that is expected to advance to Phase 1 in the second half of 2022.

OncoArendi has an exclusive collaboration and license agreement with Galapagos for the global development and commercialization of OncoArendi’s OATD-01. OATD-01 (GLPG4716) is a Phase 2-ready chitotriosidase/acidic mammalian chitinase (CHIT1/AMCase) inhibitor for the treatment of idiopathic pulmonary fibrosis (IPF) and other diseases with a fibrotic component.

OncoArendi’s headquarters and laboratories are located in Warsaw, Poland with an additional laboratories in Łódź. The company is listed on the Warsaw Stock Exchange (ticker: OAT).

For more information, please visit https://oncoarendi.com/en/ LinkedIn: @OncoArendi Therapeutics | Twitter: @oncoarendi | YouTube: @ OncoArendi Therapeutics

For further information, please contact:

OncoArendi (PR & IR)                                                          

Magdalena Licka

Email : m.licka@oncoarendi.com

MEDiSTRAVA Consulting (Financial PR)                                     

Frazer Hall, David Dible, Sandi Greenwood, Eleanor Perkin

Email: OncoArendi@medistrava.com