Interim report Q2 2022
August 19, 2022
Egetis initiates the build-up of an organization in the US and Europe for the commercialization of Emcitate®
Financial overview April-June
· Quarterly revenues MSEK 4.7 (25.0)
· Quarterly loss MSEK -33.2 (-34.3)
· Cash balances at the end of the quarter amounted to MSEK 233.2 (207.4)
· Cash flow for the period MSEK 124.3 (-41.8)
· Loss per share before/after dilution SEK -0.2 (-0.2)
Financial overview January – June
· Revenues for the period MSEK 11.8 (28.8)
· Loss for the period MSEK -62.1 (-53.6)
· Cash balances at the end of the period amounted to MSEK 233.2 (207.4)
· Cash flow for the period MSEK 86.5 (-80.1)
· Loss per share before/after dilution SEK -0.3 (-0.3)
Significant events during the period April-June
· Received approximately MSEK 180 (gross) through an oversubscribed rights issue
· Recruited Sara Melton as President of Egetis North America
· Initiated the build-up of medical affairs and the commercial organization with the recruitment of three senior leaders for the commercialization of Emcitate
· The recruitment target was met in the Triac Trial II study with Emcitate. A total of 22 patients were included in the study
Significant events after the reporting period
· Established a wholly-owned subsidiary in the United States, Egetis Therapeutics US Inc.
· Received a positive opinion from EMA regarding orphan drug status for Aladote for the prevention of acute liver failure
· In August the European Commission classified Aladote as an orphan drug for the prevention of acute liver failure
Comments from the CEO
I am very pleased with our oversubscribed rights issue in May, from which Egetis received gross proceeds of approximately SEK 180 million. This was accomplished through strong support from our current shareholders, above all the specialized life science investor Flerie Invest AB, which increased its shareholding. We further strengthened the shareholder base with a new specialist investor through Linc AB, and I welcome them as a new shareholder. The new funds raised through the rights issue will be critical to continue the stepwise establishment of a commercial infrastructure in Europe and the US for Emcitate and pre-launch activities.
The Emcitate project is progressing according to plan for the application for market approval in the US and Europe in 2023
As a result of completed discussions with the European Medicines Agency (EMA), Egetis intends to submit a marketing authorization application for Emcitate to the EMA in the first half of 2023, based on existing clinical data.
In the US, Egetis, after discussions with the FDA, will conduct a confirmatory randomized, placebo-controlled study in 16 patients to verify the results on thyroid hormone T3 levels from previous clinical trials and publications. In dialogue with the FDA, the company has finalized the protocol for this study, which is expected to start in the autumn of 2022. Egetis intends to submit an application for market approval for Emcitate in the United States in mid-2023, under the 'Fast Track Designation' granted by the FDA.
The Triac Trial II study with Emcitate is fully recruited
In April, we announced that the recruitment target of 16 patients had been reached in the Triac Trial II study of Emcitate in patients with MCT8 deficiency. After we included the patients who had already then been screened, a total of 22 patients were included in the study.
The Triac Trial II is an ongoing international, open-label, multicenter study in children with MCT8 deficiency. The study is being conducted in Europe and North America and is investigating the neurocognitive effects of early intervention with Emcitate in very young patients (<30 months old). The first patient was dosed in December 2020. The primary endpoint is two different scales for the assessment and follow-up of neurocognitive development in children, which are analyzed after 96 weeks of treatment with Emcitate. The study also evaluates whether the patients achieve certain specific motor milestones such as holding the head up and sitting independently, as well as the effect on clinical and biochemical aspects of thyrotoxicosis.
Results from Triac Trial II are expected in the first half of 2024 and are planned to be submitted to regulatory authorities after market approvals have been obtained.
Global interest in Emcitate continues to grow
There is continued great interest from physicians all over the world to treat patients suffering from MCT8 deficiency with Emcitate, which is prescribed on an individual license basis to patients in over 25 countries. In total more than 160 patients are being treated with Emcitate, and we see that more and more patients are getting access to this treatment. This underlines the great medical need for a treatment for these patients.
From April 28 to May 2, Egetis participated with an exhibition stand at the European Paediatric Neurology Society congress in Glasgow, to raise awareness of MCT8 deficiency.
Egetis has initiated the build-up of medical affairs and the commercial organization
During the period we announced four key appointments to build-up medical affairs and the commercial organization to deliver the key activities required to ensure successful launches of Emcitate in Europe and the US in 2024, following expected market approvals. Marianne Berrens-Peijnenburg has joined as Global Head of Medical Affairs, Nadia Georges as Global Head of Market Access & Pricing, and Peter Verwaijen as Global Head of Marketing & Brand Strategy. Marianne and Peter will be based in the Netherlands while Nadia will be based in Switzerland. In addition, the Company has three ongoing recruitment campaigns for country managers in key European markets.
The US is also a key market for patients suffering from MCT8 deficiency. In June we announced that Sara Melton has been recruited as 'President' for Egetis in North America. Sara will be part of the Company's management team and has over 20 years of commercial leadership experience in biotechnology, pharmaceutical and medical technology companies, including rare diseases. She will be responsible for establishing and maintaining a successful organization for Egetis and the launch of its products in the US and Canada. This includes developing relationships with key national stakeholders as well as responsibility for the development and execution of the strategy for all initiatives necessary for the successful launch of Emcitate in the US in 2024.
We have also established a wholly owned subsidiary in the United States, Egetis Therapeutics US Inc., incorporated in the state of Delaware.
Orphan drug designation in the EU for Aladote for the prevention of acute liver failure
In July, the Committee for Orphan Medicinal Products (COMP) of the EMA gave a positive opinion on the orphan drug designation of Aladote for the prevention of acute liver failure, a life-threatening condition. The European Commission decided in August on orphan drug status for Aladote for the above indication. Orphan drug designation in the EU follows the already granted orphan drug designation for Aladote for the treatment of paracetamol overdose obtained by the FDA in 2019.
There is a significant medical need for the approximately 25% of patients who reach hospital more than eight hours after paracetamol poisoning. These patients have an increased risk of acute liver failure and need additional treatment options beyond the currently available N-acetylcysteine (NAC).
The design of the pivotal Phase IIb/III study with the aim of applying for market approval in the USA and Europe has been completed after discussions with the FDA, EMA and the Medicines and Healthcare products Regulatory Agency (MHRA, UK) and the start of the study is planned later in 2022.
Thanks to our rights issue, we reported a cash position of approximately SEK 233 million as of June 30, 2022.
Egetis is an innovative and integrated pharmaceutical company, focused on projects in late clinical development phase for commercialization within the orphan drug area for the treatment of serious and rare diseases with significant medical needs. We continue to be fully focused on developing our drug candidates Emcitate and Aladote in 2022 for all the patients who have a great need for these preparations. I look forward to informing you about the future development of Egetis and welcome you to our upcoming Capital Markets Day in Stockholm on 13 October 2022.
Nicklas Westerholm, CEO