Bryan, Garnier & Co acts as Joint Global Coordinator & Joint Bookrunner on Egetis Therapeutics’ Nasdaq Stockholm SEK 210 million Follow-on Offering

Headquartered in Stockholm, Egetis Therapeutics is an integrated pharmaceutical drug development company, focusing on late-stage drug development for the treatment of serious rare diseases with significant unmet medical needs.

The Company’s lead candidate Emcitate is under development for treatment of patients with MCT8 deficiency. MCT8 deficiency is a rare disease (approx. 1 in 70,000 males) that makes the body incapable of transporting thyroid hormone in several tissues, including the brain.

Thyroid hormone is a key metabolic regulator with effects on almost all cell types and plays an important role in the development and proper function of multiple organs. Deficiency of the hormone causes impaired development of both cognitive and physical abilities and such deficiency is hence detrimental to infants’ growth and development.

Egetis Therapeutics will apply for approval based on existing data in Europe in the first half of 2023 and in the US in the middle of 2023. The Company already has more than 160 patients on Emcitate under a compassionate use program. The majority of these patients may be converted into revenue as soon as approval and reimbursement have been granted.

The net proceeds will primarily finance the 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.

Acting as Joint Global Coordinator and Joint Bookrunner alongside Carnegie, Bryan, Garnier & Co delivered a SEK 210m transaction for EGETIS THERAPEUTICS on Nasdaq Stockholm.

The pricing was set at SEK 6.00, representing a 6.7% discount to last close.

Total deal size amounted 35,000,000 shares, equivalent to SEK 220m and representing 16% of issued share capital.

Book was multiple times oversubscribed and anchored by Tier 1 institutions domestically and internationally, including AXA Investment Managers, Handelsbanken Fonder, Medical Strategy and existing shareholders.

Bryan, Garnier & Co is opening the European Healthcare ECM market with this 1st capital increase in 2023, demonstrating its unique ability to raise capital for Nordic and healthcare companies in a highly competitive fundraising environment.

Egetis Therapeutics is an innovative and integrated pharmaceutical company, focusing on projects in late-stage development for commercialization for treatments of serious diseases with significant unmet medical needs in the orphan drug segment.

The Company’s lead candidate Emcitate is under development for the treatment of patients with monocarboxylate transporter 8 (MCT8) deficiency, a highly debilitating rare disease with no available treatment. In previous studies (Triac Trial I and a long-term real-life study) Emcitate has shown highly significant and clinically relevant results on serum T3 levels and secondary clinical endpoints. As a result of fruitful regulatory interaction Egetis intends to submit a marketing authorisation application (MAA) for Emcitate to the European Medicines Agency (EMA) in the first half of 2023 based on existing clinical data.

In the US, after discussions with the FDA, Egetis will conduct a small randomized, placebo-controlled study in 16 patients to verify the results on T3 levels seen in previous clinical trials and publications. Egetis intends to submit a new drug application (NDA) in the US for Emcitate in mid-2023 under the Fast-Track Designation granted by FDA.

Emcitate is currently being investigated in the Triac Trial II, a Phase II/III study in very young MCT8 deficiency patients (<30 months of age) exploring potential disease modifying effects of early intervention from a neurocognitive and neurodevelopmental perspective. The recruitment target was achieved in the second quarter 2022 and 22 patients have been included in the study. Results are expected mid 2024 and are expected to be submitted post-approval to regulatory authorities.

Emcitate holds Orphan Drug Designation (ODD) for MCT8 deficiency and resistance to thyroid hormone type beta (RTH-beta) in the US and the EU. MCT8 deficiency and RTH-beta are two distinct indications, with no overlap in patient populations. Emcitate has been granted Rare Pediatric Disease Designation (RPDD) which gives Egetis the opportunity to receive a Priority Review Voucher (PRV) in the US, after approval.

The drug candidate Aladote is a first in class drug candidate developed to reduce the risk of acute liver injury associated with paracetamol (acetaminophen) overdose. A proof of principle study has been successfully completed and the design of the upcoming pivotal Phase IIb/III study with the purpose of applying for market approval in the US and Europe for Aladote has been finalized after completed interactions with FDA, EMA and MHRA and study start is planned during 2023. Aladote has been granted ODD in the US and in the EU.

Egetis Therapeutics (STO: EGTX) is listed on the Nasdaq Stockholm main market.