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
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
Significant events during the period April-June
·
· Dr Thomas Lönngren (Chairman) and
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
· 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
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
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
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
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,
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
Cash position
To continue the development of our clinical portfolio, we reported a cash position of approximately
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,
At the Annual General Meeting on
I am grateful to employees and directors for their support and strong belief in the company. This was illustrated amongst others by executives in
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
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