Press release
19 may 2017
Quarterly report January – march 2017
Immunicum AB (publ), First North Premier: (IMMU.ST), a biotechnology company that develops new immunaktiverande cancer treatments for a number of solid tumors publishes today its interim report including an update of how the activity developed during the first quarter of 2017.
First quarter in brief – Financial overview
- Operating profit amounted to sek -20 533 THOUSAND (-9 528 THOUSAND)
- Net profit amounted to -20 639 THOUSAND (-9 611 THOUSAND)
- Earnings per share before and after dilution amounted to sek -0,80 $ (-0,48 SEC)
- Cash and cash equivalents and short-term investments, amounted as per 31 march 2017 to 93 853 THOUSAND (42 938 THOUSAND)
- Equity per share amounted to 3.15 SEK (1,93 SEC)
- Number of employees at the end of the period 11 (7)
CEO comments the first quarter
The first quarter of 2017 was an intense period for Immunicum and we have achieved important steps on the path toward reaching our overall goal. Our primary focus is on the development of our cell-based therapy for the treatment of solid tumours, INTUVAX®, for which we completed the important progress in respect of the production (among several regulatory milestones). We have expanded our management team to build a solid foundation for achieving success and we have been active in the positioning of the Immunicum in order to compete globally in our industry.
Most important has been our success in clinical studies with INTUVAX, Immunicums unique cancerimmunaktiverare for the treatment of cancer in the kidney and liver but also for GIST (Gastrointestinal stromacellstumör).
Renal Cell Carcinoma (RCC) – Per today’s date, we have in our ongoing MERECA phase II study, where patients with nydiagnosticerad metastaserade renal cell carcinoma treated with INTUVAX in combination with sunitinib, now 58 patients recruited in 26 centres in eight european countries. This includes the treatment of the first patient in France, which is a result of the French regulatory authorities ‘ approval of the study, something we announced during the quarter. It is important to highlight the progress that this regulatory approval means: France is a large market with high regulatory requirements in cell-based therapies. To get access to the clinics and patients in France continues to support the good patientrekrytering. It also means a recognition of our approach and its potential for the treatment of cancer.
In line with what we said about the possibilities to give the details of the additional steps required for the clinical development of a cell-based therapy that INTUVAX, I am pleased to provide an update on the development of MERECA study in the united states. As we notice in december last year, Immunicum approval by the FDA of its Investigational New Drug (IND) application for INTUVAX. Since then we have focused on achieving the requirements for us to be able to begin the recruitment of patients to clinical centers in the united states. With the FDA’s go-ahead as a necessary start have Immunicum then obtained the permit for the German manufacturer of INTUVAX to produce the product in accordance with FDA’s guidelines, which required additional permits in Germany for manufacturing of INTUVAX cells. It was only after the successful production and delivery of INTUVAX to the american clinics like these could begin to pre-screen the patients. This pre-screening has been going on since the middle of april, and we expect that the first patients could be available for treatment during the second quarter of 2017.
Hepatocellular Carcinoma (HCC) – As previously announced, we have now recruited the last of the six patients who will receive INTUVAX in combination with first-line standard of care in the extended part of the study. Results from this part of the study are expected in the third quarter of 2017.
Gastrointestinal stromacellstumör (GIST) – As a result of the addition to the studieprotokollet our collaborators at the Karolinska university Hospital now recruited three patients with GIST in the clinical phase I/II study with INTUVAX.
Activities – During the first quarter, we invested a lot of time and effort in fulfilling the requirements placed on a company that should be listed on the Nasdaq Stockholm, which they also admitted in their review of our application. But based on the short amount of time for a transition to the main list delayed bolagskommittén its approval, based on a desire to see that Immunicum will also be able to maintain the level of corporate governance and communication. We are determined to meet these requirements in order to achieve a listing on Nasdaq Stockholm.
Another long-term focus to achieve our goals is that we are active in increasing awareness Immunicum and our products. In addition to that we have strengthened the management team with a person in the business I have participated in several events and conferences in the U.S. and Europe. The goal has been to introduce Immunicum to key personnel within the international biotechnology industry, including biotechnology and pharmaceutical companies, international investors and industry leaders.
We as the management team, together with the board of directors, are focused on creating value to our shareholders through the rigorous development of our clinical programs and the vision to increase the possibilities to succeed. We are grateful for your continued support and confidence.
Carlos de Sousa
President and CEO
Significant events during the quarter
- Agence Nationale de Sécurité du The et des Produits de Santé (ANSM) in France has approved the company’s clinical prövningsansökan, Clinical Trial Application (CTA) for INTUVAX. The approval allows Immunicum can include patients in France in its ongoing phase II study – MERECA (MEtastatic REnal Cell CArcinoma) – for the treatment of metastaserade renal cancer.
- After the message that a first patient has been included in the phase I/II study of gastrointestinal stromacellstumör (GIST) after the addition of the studieprotokollet recently approved by the Ethical review board and by the medical products agency in Sweden, now has three of the patients included in the study. The study is being conducted in collaboration with the Karolinska university Hospital and examines the safety and effectiveness of the INTUVAX® in combination with tyrosinkinashämmare on patients with the incurable form of GIST.
- Sijme Zeilemaker, has been recruited as a Senior Director of Business Development.
- Nasdaq the Stockholm stock exchange listing committee bordlade Immunicums application for admission to trading. Bolagskommittén noted that Immunicum has formalized and adapted its corporate governance and information disclosure to the requirements for companies listed on the Nasdaq Stockholm, but the company needs to demonstrate a longer period of the application before the committee can inform the final decision on the company’s application.
Significant events after the end of the period
- At the annual general meeting on april 26, 2017 re-elected the existing board members Agneta Edberg, Martin Lindström, Magnus Nilsson, Magnus Persson, Steven Glazer, Charlotte Edenius and Kerstin Valinder Strinnholm as members of the board. Agneta Edberg was re-elected as chairman of the board.
- The agm also decided to authorise the board of directors during the period until the next agm, on one or several occasions and with or without deviation from shareholders ‘ preferential rights, resolve on a new issue of a maximum of 2 595 000 shares, and the issuance of the warrants and/or convertible bonds that give the right to subscription of a maximum of 2 595 000 shares. Upon full exercise corresponds to the authorization and about 10 per cent of the current share capital and number of votes.
The full report is available at:
The information in this press release is such that Immunicum AB (publ) is obliged to publish under the EU marknadsmissbruksförordning. The information was submitted, by the above contact person in the government, for publication on may 19, 2017 there is a 08.00 CET.
For further information, please contact:
Carlos de Sousa, CEO, Immunicum
Telephone: +46 (0) 31 41 50 52
E-mail: info@immunicum.com
Investor relations, Sweden
Helena Stångberg
Hallvarsson & Halvarsson
Telephone: + 46 709 71 12 53
E-mail: helena.stangberg@halvarsson.se
Media contact
MacDougall Biomedical Communications
Gretchen Schweitzer or Stephanie May
Telephone: +49 89 2424 3494 or + 49 175 571 1562
E-mail: gschweitzer@macbiocom.com or smay@macbiocom.com
The company’s Certified Adviser is Redeye AB
Telephone: +46 (0) 8 545 013 31.
www.redeye.se
ABOUT IMMUNICUM AB (PUBL) Immunicum AB (First North Premier: IMMU.ST) is a company in the clinical phase of developing new immunostimulerande cancer treatments for a number of solid tumors. The company’s most advanced product, INTUVAX®, is currently being evaluated in clinical trials for the treatment of renal cell cancer, liver cancer and gastrointestinal stromacellstumör. INTUVAX® has been designed to combine the best of two worlds: a cost-effective cell-based and easy to use (allogeneic) treatment that has the ability to trigger individual and potentially långtidsvarande immune response against the tumor cells throughout the body. www.immunicum.com
Q1 2017 Swe 170519 0010