Penger på bok - og gjør klar for “the successful launch of Emcitate in 2024” i Nord-Amerika.
Egetis Therapeutics AB (publ) (Nasdaq Stockholm: EGTX) today announced the appointment of Sara Melton as President of North America. Ms. Melton will be part of the Company’s leadership team and brings over 20 years of commercial leadership experience in biotechnology, pharmaceutical, and medical device companies, including rare disease. She will be responsible for establishing and maintaining a successful presence of Egetis and its products in the United States and Canada, including building the infrastructure for Egetis North America, developing relationships with key national stakeholders, and recruiting a highly effective team to support all initiatives necessary for the successful launch of Emcitate in 2024.
juli 2022:
PAS biotech analyst Dan Akschuti interviewed Egetis Therapeutics’ CEO Nicklas Westerholm as well as board member & main shareholder Peder Walberg on the progress the company has gone through since its formation in 2020 and the exciting path ahead towards market approval in a currently untreatable rare disease affecting newborns.
Q3 report, silently moving towards final development stages
Egetis Therapeutics today released its Q3 report, which came as expected and with no new material information. At the capital markets day on October 13, the company gave a broad overview yet deep insight into its projects and strategy (link to recording). The number of treated patients remained stable compared to last quarter at over 160 by end of Q3 2022 (through named patient/ compassionate use programs). The cash burn rate has been increasing from SEK -35.3 in Q2 to SEK -42.7 (31.7) in Q3, which is related to the initiation of the 16-patient US registrational study that is expected to start any day now. Liquid funds are approximately SEK 190.1m and expected to last until Q4 2023. The stock remains highly undervalued, likely related to lack of newsflow at this point and the remaining development time, yet the path to market is clear and de-risked (we see a 75% chance of commercial success and a fully diluted potential upside to SEK 39). We therefore expect the share price to pick up sooner or later – the closer it gets to key regulatory milestones in 2023 & 1H 2024. We have a Buy rating on EGTX with a target price of SEK 24/share.
PAS’ kommentar: Attracting high profile commercial team incl. ex Biogen & Biomarin
Egetis Therapeutics today announced ten additions to its commercial and medical affairs team. All additions have a proven-track record in bringing some of the most successful rare disease drugs to the market such as Biogen’s Spinraza (peak sales in 2019 of USD 1.2bn), one of three drugs indicated for spinal muscular atrophy (SMA). Today’s news is an additional validation that Emcitate is moving towards commercialization in 2024. Based on existing clinical data and regulatory agencies feedback, we see Emcitate as highly de-risked and expect the share price to pick up the closer it will get to regulatory and commercial milestones. We reiterate our Buy rating on EGTX with a target price of SEK 24.
Emcitate® project progressing with focus on applications for market approvals in the US and EU in 2023
Financial overview October-December
· Quarterly revenues MSEK 5,7 (3,2)
· Quarterly loss MSEK -77,8 (-32,1)
· Cash balances at the end of the quarter amounted to MSEK 127,7 (144,0)
· Cash flow for the period MSEK -62,8 (-29,6)
· Loss per share before/after dilution SEK -0.4 (-0.2)
Financial overview January-December
· Revenues for the period MSEK 22,6 (38,2)
· Loss for the period MSEK -193,8 (-104,5)
· Cash balances at the end of the period amounted to MSEK 127,7 (144,0)
· Cash flow for the period MSEK -19,5 (-145,0)
· Loss per share before/after dilution SEK -1.0 (-0.6)
Significant events during the period October-December
· Hosted a Capital Markets Day on October 13 in Stockholm, where an overview of the Company’s strategy and project portfolio was presented (a video from the day can be found here)
· Continued to strengthen the commercial and medical affairs organizations for the expected launch of Emcitate in 2024
· Recruited Anny Bedard as President of Egetis North America
Significant events after the reporting period
· Received MSEK 210 (gross) through an oversubscribed directed share issue
· Recruited Katayoun Welin-Berger as Vice President Operations, responsible for designing and managing the supply chains for development candidates and commercial products. Katayoun will join Egetis from Calliditas Therapeutics in March 2023
Comments from the CEO
I am very pleased with our progress during the last quarter of 2022, which enabled our directed share issue in the beginning of 2023. The Directed Issue was oversubscribed and Egetis received SEK 210 million before transaction costs. New investors comprise institutional international and Swedish sector specialist investors, including AXA Investment Managers, Handelsbanken Fonder AB through the investment fund Hälsovård Tema, and Medical Strategy GmbH, as well as existing investors including The Fourth Swedish National Pension Fund (AP4), Linc AB and Unionen. The net proceeds from the Directed Issue will primarily finance continued build-up of the Company’s commercial infrastructure in Europe and the US and pre-launch activities for the planned commercialization of Emcitate in 2024, as well as general corporate purposes and financial flexibility.
PAS etter rapport: Q4 takes – waiting for progress of the programs
Egetis Therapeutics today released their Q4 report with no new material information. The number of patients on Emcitate increased from over 160 to over 170, showing the need for the ultra-rare disease drug. In late 2021, the company communicated that they would have to conduct a small 16 patients’ trial for the FDA, yet over 1 year later it has still not started. In July 2022, we suspended the second program Aladote from our valuation of the company due to lack of progress since 2018. After continuous delays of the program, the company still communicated that the next clinical trial should start in 2H 2022, in the Q3 2022 report that it should start early 2023 and now in the Q4 the company continues with that practice and mentions a start “within 2023”. We hope the company soon delivers clinical progress & does not continue for Emcitate as with Aladote. The cash burn was slightly up with SEK -63 for the quarter and ending cash balance was SEK 128 to which the company added SEK 210 before transaction costs through an equity offering this quarter, which should last the company into Q1 2024. We have a Buy rating on EGTX with a target price of SEK 24.
mars 2023 kl. 16:20 CESTUpdated on30. mars 2023 kl. 17:38 CEST
Egetis Therapeutics AB, a Swedish developer of rare disease treatments, said it’s been holding talks about a potential sale.
The Stockholm-based company “has ongoing discussions with certain external parties regarding a potential acquisition of the company,” Egetis said in a statement Thursday, confirming an earlier Bloomberg News report. It said there was no certainty any takeover offer will be made.
Egetis has been working with an adviser to gauge interest from potential buyers including large drugmakers, people with knowledge of the matter said earlier.
Shares of Egetis were up 38% at the close Thursday in Stockholm, marking the biggest daily gain since April 2020 and giving the company a market value of 1.75 billion kronor ($169 million). It earlier jumped as much as 45%.
The company is developing a drug for Allan-Herndon-Dudley syndrome, a debilitating genetic disorder that disrupts children’s brain development and can leave patients wheelchair-bound. It’s also been working on a treatment for paracetamol poisoning.
Health care dealmaking has been picking up as big pharmaceutical companies seek to replenish their pipelines. In January, AstraZeneca Plc agreed to buy US biotech firm CinCor Pharma Inc. for as much as $1.8 billion to gain a promising new treatment for hypertension and kidney disease. Sanofi said earlier this month it will acquire Provention Bio Inc. in a $2.9 billion deal to bolster its portfolio of diabetes medicines.
