Interim report January - March 2019

Mölndal, May 15, 2019 – Vicore Pharma Holding (publ) publishes the interim report for the first quarter 2018.

Important events during the first quarter

• In January, the directed share issue of approximately 160 MSEK was approved by an Extraordinary General Meeting. The total number of shares after the share issue amounts to 42,374,714.

Important events after the period

• Vicore Pharma announced on April 23 that it has selected the disease diffuse systemic sclerosis (dSSc) as the second indication for its lead program VP01 (C21). It complements the primary indication, idiopathic pulmonary fibrosis (IPF).

Financial overview for the period 
January 1 - March 31, 2019

• Operating income amounted to 0.0 MSEK (0.2)
• Operating loss was -16.1 MSEK (-7.2)
• Loss for the period was -16.0 MSEK (-0.2)
• Loss per share, before and after dilution, was -0.40 SEK (-0.01)
• On March 31, 2019, cash and cash equivalents amounted to 216.0 MSEK (13.7)

1. There is no dilutive effect for potential ordinary shares based on exercise of options and share rights, since the net results for the periods presented above have been negative.

CEO Comments

Vicore has a strong focus on developing an attractive portfolio of medicines for the treatment of rare lung diseases such as idiopathic pulmonary fibrosis (IPF) and other indications matching the specific properties of our most advanced drug candidate VP01 (C21). When you also include the second candidate VP02 (IMiD) for IPF and the associated IPF cough, we have two unique and differentiated drug development programs in our portfolio. In 2019, we will continue the focused development of our pipeline with the patient in the forefront of our minds.

Currently, we have intensified our effort into two phase IIa studies with VP01 that will begin in the second half of 2019, a proof-of concept study in IPF patients, and a mechanistic study in patients with dSSc. The design of the studies will enable us to identify potential value-creating therapeutic effects of our drug. The VP01 program is currently in an extended phase I study for dose optimization.

The formulation work of VP02 is ongoing and the goal for this year is to identify a formulation with the desired properties. The next step is to carry out toxicological work and then a phase I study in 2020.

To implement our plans, we are building a strong medical team. Rohit Batta, with extensive experience from orphan drug programs with GlaxoSmithKline, and Göran Tornling as our resident pulmonology medical expert, ensure that our study designs will be of good standard. In addition, the in-house clinical operations team, under the leadership of Mimi Flensburg, is critical in securing the oversight of the conduction of our trials. A top notch internal clinical organization is crucial to deliver quality. This personalised approach is critical in rare diseases and provides us the ability to readily communicate directly with investigators and sites plus a supervised control over our data to maximise quality. This makes us nimbler relative to just simply handing this to a contract research organization but instead working with them in tandem so that the study can be executed with maximal efficiency.

In parallel to the strong focus on developing our pipeline, preparations for the listing of our shares on Nasdaq Stockholm’s main list have high attention. The listing is an important step to further increase the attractiveness of our share.

In summary, 2019 will become an exciting and eventful year for Vicore. We will continue to build the company, at a high pace and with a strong focus. 

For further information, please contact:

Carl-Johan Dalsgaard, VD, tel: + 46 (0)70 975 98 63, carl-johan.dalsgaard@vicorepharma.com   

Hans Jeppsson, CFO, tel: +46 (0)70 553 14 65, hans.jeppsson@vicorepharma.com 

Christian Hall, IR-manager, tel: +46 (0)76 311 12 42, christian.hall@vicorepharma.com

This information was submitted for publication on 15 May 2019 at 08:00 CEST.

About Vicore Pharma Holding AB (publ)
Vicore Pharma is a Swedish rare disease pharmaceutical company focused on interstitial lung diseases and related indications. The company currently has two drug development programs, VP01 and VP02. 

VP01 aims to develop the substance C21 for the treatment of idiopathic pulmonary fibrosis (“IPF”) and diffuse systemic sclerosis (“dSSc”). As a result of the acquisition of INIM Pharma AB in August 2018, the company’s pipeline expanded with a second drug development program, VP02. VP02 is based on a new formulation and delivery route of an existing immunomodulatory compound (an “IMiD”). VP02 focuses on the underlying disease and the severe cough associated with IPF. VP01 and VP02 are also being actively evaluated for other indications within the field of interstitial lung diseases which has a significant high unmet need. The acquisition of INIM Pharma meant an expansion of Vicore Pharma's operation and a clear strategy focused on developing drugs for the treatment of rare and severe lung diseases. VP01 is currently within an extended phase I study and the start of the Phase IIa study in IPF patients is expected to commence during the second half of 2019. VP02 is entering a phase of optimization of formulation before local tolerability studies will commence. The first clinical studies with VP02 are expected to start in 2020. 

The company's share (VICO) is listed for trading on Nasdaq First North in Stockholm. The company´s certified adviser is Erik Penser Bank, telephone: +46 8 463 83 00, e-mail: certifiedadviser@penser.se. For more information, see www.vicorepharma.com

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