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Egetis is an innovative, unique, and integrated pharmaceutical drug development company, focusing on projects in late-stage development for treatment of serious rare/niche diseases with significant unmet medical needs in the orphan drug segment

Emcitate development program progressing according to plan

August 19, 2021

Financial overview April-June
· Quarterly net revenues MSEK 25.0 (21.7)
· Quarterly loss MSEK -34.3 (-36.2)
· Cash and cash equivalents MSEK 207.4 (184.5)
· Cash flow for the period MSEK-41.8 (-33.8)
· Loss per share before/after dilution SEK -0.2 (-0.7)

Financial overview January – June
· Net revenues for the period MSEK 28.8 (33.2)
· Loss for the period MSEK -53.6 (-79.0)
· Cash and cash equivalents MSEK 207.4 (184.5)
· Cash flow for the period MSEK -80.1 (-71.1)
· Loss per share before/after dilution SEK -0.3 (-1.5)

Significant events during the period April-June
· Kristina Sjöblom Nygren, MD, joined Egetis Therapeutics as Chief Medical Officer (CMO) and Yilmaz Mahshid, PhD, joined Egetis Therapeutics as Chief Financial Officer (CFO).
· Dr Thomas Lönngren (Chairman) and Mats Blom were elected as new Directors of the Board at the Annual General Meeting on the 29th of April.

Emcitate®
· Patient recruitment in the pivotal Phase IIb/III early intervention study with the drug candidate Emcitate progresses according to plan. Patient recruitment is expected to be completed in Q4 2021.
· Continued interest in the opportunity to treat MCT8 deficiency with Emcitate from physicians across the globe. Emcitate is supplied on a named patient basis in several countries, following special approval from the national regulatory authority with more than 120 patients in total already getting access to Emcitate treatment.

Aladote®
· Aladote was presented at the scientific meeting of the American College of Medical Toxicology (ACMT) on April 14, under the heading Antidote Updates.
· Preparation for the pivotal Phase IIb/III study for Aladote continues targeting study start at the end of 2021, pending the COVID-19 pandemic situation.
 
PledOx®
· The company has parked further PledOx development following the POLAR results. Our partner Solasia Pharma KK will continue the pre-clinical program in taxane induced peripheral neuropathy.
Significant events after the reporting period
· The results of the prematurely discontinued POLAR program with PledOx were presented at the ESMO World Congress on Gastrointestinal Cancer on July 2.

Comments from the CEO
The second quarter continued the positive momentum of integrating RTT (Rare Thyroid Therapeutics) and progressing the Emcitate development program. We have indeed sustained the good start to Egetis Therapeutics, dedicated to development and commercialization of therapies for rare diseases, with two important assets Emcitate and Aladote – both in late-stage clinical development. Our aim is to offer medicines to patients with serious and rare diseases lacking adequate medical treatments and thereby create value for patients, shareholders and society.

Recruitment to the Phase IIb/III study TRIAC II with Emcitate is progressing well according to plan
Emcitate, which has been granted Orphan Drug Designation (ODD) in both EU and the US and received a US Rare Pediatric Disease designation (RPD) in November 2020, is being developed for the treatment of MCT8 deficiency, a rare congenital disorder of thyroid hormone trafficking with detrimental natural history and no currently available therapy. Approximately 1 in 70,000 males are affected.
Patient recruitment to the TRIAC II study with Emcitate progressed well in the second quarter, and the recruitment is expected to be completed in Q4 2021 according to plan. I am gratified that we continue to recruit patients to the study according to plan despite the challenging Covid-19 situation. Interim results are targeted to be available in Q4 2022 and are expected to pave the way for regulatory approvals and commercial launch. TRIAC II is an international, open label, multi-center study in children younger than 30 months with MCT8 deficiency, conducted in both Europe and North America.
We also see a continued interest from physicians across the globe to treat patients that suffer from MCT8 deficiency with Emcitate. Emcitate is supplied on a named patient basis, following individual regulatory approval from the national regulatory agency. Named patient access is a mechanism to allow for early access before market approval to important and life-saving medicines in situations with high unmet medical needs and where no available treatment alternatives exist or are suitable. Already more than 120 patients in more than 20 countries have been granted such named patient approval and are being treated with Emcitate, underlining the significant unmet medical need in this patient population.

Preparations for the Aladote pivotal Phase IIb/III study are ongoing
Preparations for the planned Phase IIb/III study with Aladote are ongoing in the US, UK and EU together with the selected CRO. The Covid-19 pandemic is still making it very challenging to start a clinical study in an emergency/intensive care setting. Therefore, pending how the situation evolves, we expect study start will likely take place at the end of this year.
We remain committed to the continued development of Aladote, which has the potential to be the first approved drug to benefit patients with an increased risk of liver injury, who are not adequately treated with NAC after a paracetamol overdose. Aladote has been granted ODD in the US, and an application for an ODD in the EU was submitted to the EMA in March.
We continue to see a strong interest in the scientific community for Aladote. At the scientific meeting of the American College of Medical Toxicology (ACMT) in April Professor James Dear from the University of Edinburgh, UK, presented Aladote as a novel emerging treatment of paracetamol overdose.

Cash position
To continue the development of our clinical portfolio, we reported a cash position of approximately 207 million SEK on June 30, 2021, which is planned to finance the development of Emcitate and Aladote.

Strengthened organization and board
We continued to strengthen the company, in order to adapt to our new strategic direction, prepare for the next steps of our clinical programs and ultimately launch our innovative drug candidates. In May, Kristina Sjöblom Nygren, MD, joined us as Chief Medical Officer (CMO). In June, Yilmaz Mahshid, PhD, joined the company as Chief Financial Officer (CFO). I worked with Yilmaz for three years at PledPharma and am pleased to renew this fruitful collaboration.
At the Annual General Meeting on April 29, Dr Thomas Lönngren (chairman) and Mats Blom were elected as new Board of Directors. We are grateful to have Thomas and Mats on the Board adding valuable experience, knowledge and expertise to Egetis when building the company with focus on orphan late-stage development, registration and commercialization for the future. Among other things, Thomas’s ten-year tenure as Head of the European Medicines Agency (EMA) will provide superior expertise of the regulatory framework in the life science sector.
 I am grateful to employees and directors for their support and strong belief in the company. This was illustrated amongst others by executives in Egetis Therapeutics acquiring shares. We have proactively continued to promote the company’s equity story and participated at a number of conferences during the period, including ABG Life Science Summit, Erik Penser Bank Commercialization of Pharmaceuticals, and Redeye Orphan Drugs event.

Looking ahead
Our focus on our clinical candidates with their opportunity to provide treatment for patients suffering from rare and serious diseases is firm as we shape the future of Egetis, our exciting company focusing on the orphan drug and rare disease segment. We continue to carefully monitor the impact of the Covid-19 pandemic and take every precaution to ensure that staff, collaborators, and study participants are safe and stay well, while progressing our clinical studies with high data quality.
I believe we are well positioned to deliver on our projects Emcitate and Aladote and their respective development programs. I look forward to relaying news to you around the projects and the progress of Egetis Therapeutics.

Nicklas Westerholm, CEO

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Phone: +46 8 679 72 10

E-mail: info@egetis.com