Interim report April-June 2019

Mölndal, August 23, 2019 – Vicore Pharma Holding (publ) publish the interim report for the second quarter 2019.

Important events during the second quarter

• In April, Vicore Pharma announced 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)

Important events after the period

• No significant events have taken place after the period.

Financial overview for the period
April 1 - June 30, 2019

• Operating income amounted to 0.0 MSEK (0.2)
• Operating loss was -24.8 MSEK (-9.6)
• Profit/Loss for the period amounted to -26.6 MSEK (7.1)
• Profit/Loss per share, before and after dilution, was -0.63 SEK (0.40)
• On June 30, 2019, cash and cash equivalents amounted to 193.5 MSEK (224.7 MSEK as of December 31, 2018).

Financial overview for the period
January 1 - June 30, 2019

• Operating income amounted to 0.0 MSEK (0.4)
• Operating loss was -40.9 MSEK (-16.8)
• Profit/Loss for the period amounted to -42.6 MSEK (7.0)
• Profit/Loss per share, before and after dilution, was -1.02 SEK (0.39)

CEO Comments 

During the second quarter we continued the intensive work to develop Vicore. We have 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 conditions 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 debilitating IPF cough, we have two distinctive and differentiated development programs within our portfolio. During the year, we will continue the focused development of our projects with the patient in the forefront of our minds.

In April, we were pleased to announce diffuse systemic sclerosis (dSSc) as the second indication for VP01 besides IPF. The disease has the highest mortality amongst all the rheumatological conditions and no approved disease modifying treatments exist. The strong upregulation of the angiotensin II type 2 receptor in dSSc provides us with the belief that VP01 could be highly interesting for this indication and thus another exciting opportunity. There is a clear logic in examining the effect on the vascular mechanisms of dSSc as a complement to the antifibrotic effects tested in IPF.

Two phase IIa studies, in patients with IPF and a mechanistic study in dSSc respectively, are on track to commence in the second half of 2019.

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

To implement our plans, we have built a strong medical and regulatory team. Rohit Batta, with extensive experience from orphan drug programs with GlaxoSmithKline, and Göran Tornling as our resident pulmonology medical expert, ensure that our patient centric study designs have an efficient, systematic and innovative approach. In addition, the in-house clinical operations team, under the leadership of Mimi Flensburg, is critical in securing the oversight of our trials. We have also appointed a senior regulatory partner with extensive rare disease experience, Rick Lilly, based in the UK to support us in our engagements with regulators. A top notch internal 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.

Developing and maintaining trusted relationships with the patient community is critical in rare diseases, and in Q2 we were delighted to become a bronze corporate sponsor for the EU-IPFF (European Idiopathic Pulmonary Fibrosis and related disorders Federation patient advocacy group). It is also a privilege to be invited to speak at their AGM.

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

Carl-Johan Dalsgaard, CEO

For further information, please contact:

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

Hans Jeppson, 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 23 August 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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