Interim report January-September 2019

Gothenburg, November 8, 2019 - Vicore Pharma Holding AB (publ) publish the interim report for the third quarter 2019. 

Important events during the third quarter

• In September, Vicore Pharma announced the outcome of the dose escalation phase I study with VP01 (C21). The study established that 200 mg daily has a good safety profile and that it was the maximum tolerated dose. This dose will be used in the planned phase II studies in idiopathic pulmonary fibrosis (IPF) and systemic sclerosis (SSc).
• In September, Vicore was approved for uplisting to Nasdaq Stockholm. First day of trading was on September 27.

Important events after the period

• No significant events have taken place after the period.

Financial overview for the period
July 1 – September 30, 2019

• Operating income amounted to 0.0 MSEK (0.1)
• Operating loss was -22.8 MSEK (-11.2)
• Profit/Loss for the period amounted to -22.9 MSEK (-14.9)
• Profit/Loss per share, before and after dilution, was -0.54 SEK (-0.65)
• On September 30, 2019, cash and cash equivalents amounted to 172.2 MSEK (224.7 MSEK as of December 31, 2018)

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

• Operating income amounted to 0.0 MSEK (0.5)
• Operating loss was -63.8 MSEK (-27.9)
• Profit/Loss for the period amounted to -65.5 MSEK (-8.0)
• Profit/Loss per share, before and after dilution, was -1.56 SEK (-0.41)

Financial summary of the group

CEO Comments

During the third quarter we continued the intensive and long-term work to develop Vicore into a company with 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 C21 within the VP01 project. This, together with our second project VP02 (IMiD) for IPF and the associated debilitating cough, means that we have two distinctive and differentiated development programs within our portfolio.

In early September, we completed a 54-subject phase I dose escalation study with C21. The study established that 200 mg daily has a good safety profile and that it is the maximum tolerated dose. This dose will be used in our planned phase II studies in idiopathic pulmonary fibrosis (IPF) and systemic sclerosis (SSc). Moreover, based on receptor binding data, we have concluded that this dose results in a free C21 plasma concentration that is sufficient to activate the angiotensin II type 2 receptor (AT2R) in our upcoming phase IIa trials. It is also exciting that we could confirm a dual action through both the AT2 and the thromboxane (TP) receptor. The relative role of the effects of C21 on these two receptors will be further investigated, particularly as both mechanisms are relevant for addressing fibrosis and vasculopathy, giving C21 a unique profile since also TP receptor activation may contribute to disease manifestations.

During the third quarter we filed a phase II CTA (clinical trial application) with the MHRA, the regulatory body in the UK, for studying the effect of a single dose of C21 on cold induced vasoconstriction in subjects with systemic sclerosis (SSc). This study will enable us to document a direct vasodilatory effect of C21 in man which may benefit patients with SSc, as well as patients with IPF.

During the quarter the pharmaceutical formulation development in VP01 progressed ahead of schedule allowing us to switch from an oral solution to capsules in the upcoming phase II proof of concept study in IPF. This is a significant advancement since a capsule formulation is much more nimble for the patient, superior from a logistical point of view and could be used in the commercial setting if the product reaches the market. The application for the IPF study with the new formulation is expected to be filed later this year.

The formulation work of VP02 continues and progresses in line with our goal for this year, 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 initiate a phase I study  in 2020.

On September 27, we reached an important milestone through the up-listing of Vicore’s shares to Nasdaq Stockholm’s main list. This is key to increase the attractiveness of our share longer term, mainly through enhanced liquidity, as the potential investor base grows significantly.

In summary, we continue to build Vicore, at a high pace and with a strong focus to maximize the probability of succeeding with our two main projects and thereby helping patients with serious lung diseases.

Carl-Johan Dalsgaard, CEO

The full interim report is available at: https://vicorepharma.com/investors/financial-reports/

For further information, please contact:

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

This information was submitted for publication on November 8 2019 at 08:00 CET.

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 systemic sclerosis (“SSc”). 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 VP01 Phase IIa studies in IPF and SSc patients are expected to be initiated 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 be initiated in 2020. 

The company's shares (VICO) are listed on Nasdaq Stockholm’s main market. For more information, see www.vicorepharma.com.