Healthcare, ECM

Bryan, Garnier & Co acts as Sole Global Coordinator and Sole Bookrunner to Egetis Therapeutics on a Combined Offering of SEK 462m

Headquartered in Stockholm, Egetis Therapeutics is an integrated pharmaceutical drug development company, focusing on late-stage drug development for the treatment of ultra-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 applied for approval in Europe on October 2023. The Company already has more than 180 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 continue financing Emcitate’s development, applications for market authorisations for Emcitate in the EU and the US as well as the continued build-up of the company’s commercial and medical affairs infrastructure including pre-launch activities, as well as general corporate purposes and financial flexibility.

Acting as Sole Global Coordinator and Sole Bookrunner, Bryan, Garnier & Co delivered a SEK 462m Combined offering for Egetis Therapeutics on Nasdaq Stockholm.

The transaction consisted of a SEK 172m PIPE led by US healthcare investor Frazier Life Sciences and SEK 290m debt financing obtained from BlackRock (formerly Kreos).

The pricing was set at SEK 4.00, representing a +2.3% premium to the last close, and the stock rose by +28% the day following the offering.

The PIPE process was run through several months alongside key US specialist investors and resulted in demand well above the 20% authorized mandate with several termsheets received.

This is the first combined offering of Equity and Debt by a listed Swedish company.

The transaction comes after Bryan, Garnier & Co re-opened the European Healthcare ECM market in 2023 with a previous capital increase for Egetis Therapeutics, demonstrating its unique ability to raise capital for Nordic and healthcare companies in a highly competitive fundraising environment.

"Thanks to this transaction, we're poised to advance Emcitate's development and fortify our infrastructure as we continue progressing towards a New Drug Application (NDA) in 2024 in the US, to bring the first approved treatment for MCT8 deficiency to patients. Bryan, Garnier & Co's ability to market our story to US-based healthcare specialist institutions and to orchestrate a landmark transaction structure in Sweden combining both equity and debt with Frazier Life Sciences and BlackRock (formerly Kreos), made this financing round a great success."

— Nicklas Westerholm – CEO Egetis

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 drug 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 thyroid hormone T3 levels and secondary clinical endpoints. Egetis submitted a marketing authorisation application (MAA) for Emcitate to the European Medicines Agency (EMA) on October [9], 2023. After a dialogue with the FDA, Egetis is conducting a small randomized, placebo-controlled pivotal study (ReTRIACt) in 16 patients to verify the results on T3 levels seen in previous clinical trials and publications. Topline results are expected during the first half of 2024 and Egetis intends to submit a new drug application (NDA) in the US for Emcitate in mid 2024 under the Fast-Track Designation granted by FDA. 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. This voucher can be transferred or sold to another sponsor. 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 after Emcitate submissions have been completed. Aladote has been granted ODD in the US and in the EU.