Year-end report 2018

Mölndal, March 15, 2019 – Vicore Pharma Holding (publ) (ticker: VICO) publish the year-end report for 2018

Important events during the fourth quarter

  •  In October, Vicore announced that the rights issue completed in September was oversubscribed by 33% and raised approximately 82 MSEK
  •  In October, Göran Wessman announced his resignation from the board of directors due to health reasons
  •  In November, the board of directors decided to act for the company’s shares to be admitted for trading on the Nasdaq Stockholm’s main list in 2019
  •  In November, the board of directors resolved on a directed share issue raising approximately 160 MSEK

Important events after the period

  •  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

Financial overview during the period Oct 1 to Dec 31, 2018

  •   Operating income amounted to 0.1 MSEK (0.3)
  •   Loss for the period was -13.8 MSEK (-9.1)
  •   Loss per share, before and after dilution, was -0.42 SEK
     (-0.26)
  •  On December 31, 2018, cash and cash equivalents
     amounted to 224.7 MSEK (24.0)

Financial summary of the group

Amounts in MSEK Oct-Dec
2018
Oct-Dec
2017
Jan-Dec
2018
Jan-Dec
2017
Jan-Dec
2016
Operating income 0.1 0.3 0.6 1.0 0.9
Operating loss -13.7 -9.1 -44.3 -28.6 -20.1
Loss for the period -13.8 -9.1 -21.7 -24.2 -24.5
Loss per share, before/after dilution (SEK)1 -0.42 -0.26 -0.95 -1.43 -1.77
Equity at the end of the period 295.5 57.6 295.5 57.6 31.6
Cash flow from operating activities -35.7 -5.9 -43.1 -27.9 -20.7
Cash and cash equivalents at the end of the period 224.7 24.0 224.7 24.0 4.3

CEO comments

2018 has indeed been a transformative year for Vicore, with the acquisition of INIM Pharma in July through an issue in kind, where Vicore gained an active and long-term owner in HealthCap. The subsequent streamlining of operations included the distribution of the majority of the shares held in I-Tech and creating a rare disease company with focus on patients with fibrotic lung disease. Vicore is now determined to develop a product portfolio targeting idiopathic pulmonary fibrosis (IPF) and other associated lung disorders. The emphasis has been on three important success factors: (1) securing financing; (2) building a world class team and (3) developing the pipeline including the design of the key phase II trial with the lead program VP01 (C21) in IPF to enable the detection of a therapeutic effect

The shareholders’ confidence in Vicore’s acquisition of INIM and start of transformation was confirmed in the over-subscribed rights issue which was completed in October, raising 82 MSEK. The Board of Directors also resolved on a directed share issue, raising 160 MSEK, to finance the new business plan. The directed issue was successfully performed in November and gained significant interest among a number of Swedish and international long-term institutional investors and sector specialist funds. Taken together, we raised approximately 242 MSEK in a few months which will enable us to execute on our plan to reach value-driving milestones for our key programs. In November, the Board of Directors decided to act for an up-listing of the company’s shares to the Nasdaq Stockholm main list. The up-listing will be a significant milestone for the company and aims to provide increased liquidity of its shares and increase the level of visibility for the company.

In order to execute on the new plans we are building a world class team, starting in the medical area with Dr. Rohit Batta as the new CMO. Dr Batta has been involved in GSKs pulmonary hypertension efforts and more recently bringing the pediatric gene therapy product Strimvelis to the market. Furthermore, Dr. Göran Tornling was employed as senior medical advisor who together with our external international clinical advisors, Professor Toby Maher and Dr Maureen Horton, bring significant disease specific expertise to the company. In addition we are building an internal clinical operations unit to secure control of future clinical trials.

Through the acquisition of INIM, Vicore also strengthened its Board of Directors with two experienced new board members; Hans Schikan and Jacob Gunterberg. Other key recruitments include Dr Johan Raud as CSO and Dr Ola Camber as responsible for CMC.

Following my appointment as CEO of Vicore in September, we made a strategic review of Vicore’s lead program VP01 (C21) and how we best could build on its unique profile to capture a functional effect already in our first patient trial. By redesigning the trial - extending the duration of treatment, increasing the number of subjects and monitoring lung function – we will be able to potentially detect a value-driving therapeutic effect of our drug. Together with exploring a second indication for VP01 and developing the VP02 (IMiD) program for IPF and IPF cough, we have two unique and differentiated drug development programs.

Goals for 2019

  •  Complete Phase I for VP01 (C21) with the extended dosing
  •  Initiate the Phase IIa study with VP01 (C21)
  •  Select a second indication for VP01 and initiate a mechanistic pilot study in patients
  •  Investigate safety and kinetics of the local VP02 (IMiD) programme
  •  Up-list to the Stockholm Nasdaq main list

All in all, 2018 was indeed a transformative year for Vicore, and building on what we now have initiated, I see Vicore taking off with value driving activities with the start of our phase II trial as the most important activity during 2019. This will help to make Vicore more visible among patients, doctors and other stakeholders.

I am looking forward to keeping you updated on our progress

Carl-Johan Dalsgaard, CEO 

For further information, please contact:

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

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

This information is information that Vicore Pharma Holding AB is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication through the agency of the contact person set out above, at 08:00 CET on March 15, 2019.

About Vicore Pharma Holding AB (publ)

Vicore Pharma is a Swedish rare disease 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”). As a result of the acquisition of INIM Pharma AB in August 2018, the Company’s pipeline was 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 IPF with regards to both the underlying disease and the severe cough associated to IPF. C21 and IMiD are also evaluated for other indications within interstitial lung diseases. The acquisition of INIM Pharma meant an expansion of Vicore Pharma's operation and that the Company's strategy focused on developing drugs for the treatment of rare and severe lung diseases. VP01 will perform the expanded dose escalating Phase I study and  then start the Phase IIa study in IPF patients 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

About Us

Vicore Pharma develops drugs that act through the AT2 receptor. The company’s drug candidate C21 aims to improve the treatment of idiopathic pulmonary fibrosis, a rare disease for which C21 has been granted orphan drug designation both in the EU and the US. In addition, C21 is explored pre-clinically in a number of rare diseases where the AT2 receptor plays an important role. Vicore Pharma is based in Astra Zeneca's Bioventurehub in Mölndal. The company's share (VICO) is listed for trading on Nasdaq First North in Stockholm with Erik Penser Bank as Certified Adviser. For more information, see www.vicorepharma.com

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