IMMU Immunomedics Inc

For immediate release Press Release

19 May 2017

Immunicum: Quarterly Report January-March 2017

Immunicum AB (publ; First North Premier: IMMU.ST), a biopharmaceutical company advancing a novel immuno-oncology treatment against a range of solid tumors, today announced its financial results and a corporate update for the first quarter 2017.

First quarter in brief
Financial summary

• Operating loss amounted to TSEK -20,533 (-9,528 TSEK)
• Net loss amounted to TSEK -20,639 (-9,611 TSEK)
• Earnings per share before and after dilution amounted to SEK -0.80 (SEK -0.48)
• Bank balances and short-term investment amounted to TSEK 93.853 (TSEK 42.938)
• Shareholders' equity per share amounted to SEK 3.15 (SEK 1.93)
• Number of employees at the end of the period was 11 (7)

CEO Statement - first quarter

The first quarter of 2017 was an intense period of activity for Immunicum and the Company's management team has achieved key steps on the path toward reaching our overall goals.  Our primary focus is on the continued development of our cell-based therapy for the treatment of solid tumors, INTUVAX®, for which we completed important manufacturing advances among other regulatory milestones; we have expanded our leadership team to build a solid foundation to achieve success and we have been active in positioning Immunicum to compete on a global basis in our industry.

Most important has been our progress in the clinical trials with INTUVAX, Immunicum's unique cancer immune primer for the treatment of kidney and liver cancer as well as GastroIntestinal Stromal Tumors (GIST).

Renal Cell Carcinoma (RCC) - As of today, the enrollment process for the ongoing MERECA phase II study, where patients with newly diagnosed metastatic renal cell carcinoma are treated with INTUVAX in combination with sunitinib, is that we have a total of 58 patients enrolled at 26 centers in eight European countries.  We are excited to include in this total the treatment of the first patient in France, resulting from the approval by the French regulatory authorities for the trial, as we announced in the first quarter.  It is important to emphasize the achievement this regulatory approval represents:  France is a large market and one that is highly regulated in particular for cell-based therapies.  Gaining access to the clinics and patients in France supports further patient enrollment. It also provides further recognition of our approach and its potential for treating cancer.

Along the lines of providing detail on the additional steps required for the clinical development of a cell-based therapy like INTUVAX, I am pleased to give an update on the extension of the MERECA trial in the United States. As announced in December 2016, Immunicum received clearance on its Investigational New Drug (IND) application to the Food and Drug Administration (FDA) with INTUVAX. Since that time, we have focused our efforts on achieving all the steps needed to enable the recruitment of patients in the clinical centers in the US. With the FDA clearance as the necessary start of the process, Immunicum has since obtained authorization for the German INTUVAX manufacturing facility to produce the product as defined by the FDA, which required additional approvals in Germany for the production of the INTUVAX cells. Only after the successful production and shipping of INTUVAX to the centers in the US could the clinicians at those centers start the pre-screening of patients for the trial.  At this stage, the pre-screening process has been underway since mid-April, and we anticipate the first patients to be ready for treatment during the second quarter of 2017.

Hepatocellular Carcinoma (HCC) - As previously reported, we have now enrolled the last of the six additional liver cancer patients that receive INTUVAX concomitantly with first line standard of care medication in the extension of the study.  Top line results from this trial are expected in the third quarter of 2017.

GastroIntestinal Stromal Tumors (GIST) -Following the protocol amendment, our collaborators at the Karolinska UniversitetsSjukhuset have now enrolled 3 patients in our clinical phase I/II study with INTUVAX in patients with GIST.

Operations - Over the course of the first quarter we invested time and effort in meeting all the requirements for the Nasdaq Stockholm uplisting process, which the committee acknowledged we had achieved in their review of our application. As we announced earlier this quarter, the committee delayed their approval based on the desire to see that we can maintain all corporate governance and communications standards in an ongoing manner and establish a longer track record.  We are committed to meeting these requirements to achieve our listing on the Nasdaq Stockholm. 

As another focus for the long-term achievement of our corporate goals, we remain active in raising the awareness of the Company and our products in development.  In addition to adding a key member to the team to support overall business development, during the first quarter, I have been active at several events and conferences in the US and Europe. The goal is to introduce the Company to key audiences in the international biotechnology industry, including other biotech and pharmaceutical companies, international investors and industry thought-leaders. 

We as a leadership team, together with the Board of Directors, are focused on building value for our shareholders through the rigorous development of our clinical programs and the vision to increase the opportunities for success. We are grateful for your continued support and confidence.

Carlos de Sousa
President and CEO

  Business highlights

• The Agence Nationale de Sécurité du Médicament et des Produits de Santé (ANSM) in France approved the Company's Clinical Trial Application (CTA) for INTUVAX.  The CTA approval enables Immunicum to include patients in France in its ongoing Phase II study - MERECA (MEtastatic REnal Cell CArcinoma) - for the treatment of metastatic renal cell cancer. 
• Following the announcement in the first quarter of the first patient enrolled in the Phase I/II Gastrointestinal Stromal Tumor (GIST) study following the study protocol amendment as approved by the ethical committee and the Swedish Medical Products Agency, a total of 3 patients have now been included in the trial. The study is conducted in collaboration with the Karolinska Sjukhuset and investigates the safety and efficacy of INTUVAX® in combination with tyrosine kinase inhibitors in patients with incurable GIST.
• Sijme Zeilemaker joined the leadership team of Immunicum as Senior Director, Business Development.
• Nasdaq Stockholm's listing committee postponed the decision on Immunicum's application for admission to trading. Although the committee recognized that Immunicum has achieved the requirements needed for companies listed on Nasdaq Stockholm, the committee requested that Immunicum continues to apply them for a longer period before the committee can make a final decision on the application.

Significant events after end of period

• At the Annual General Meeting on April 26, 2017, The AGM re-elected the current board members Agneta Edberg, Martin Lindström, Magnus Nilsson, Magnus Persson, Steven Glazer, Charlotte Edenius and Kerstin Valinder Strinnholm as board members. Agneta Edberg was re-elected as chairman of the board of directors.
• The AGM resolved to authorize the board, for the period until the end of the next annual general meeting, at one or more occasions and with or without deviation from the shareholders' preferential rights, to issue a maximum of 2,595,000 new shares and warrants or convertible debentures giving a right to subscribe for a maximum of 2,595,000 shares. If fully exercised, the authorization corresponds to approximately 10 percent of the current share capital and votes in the Company.

The full quarterly report is available on:

http://immunicum.se/investors/financial-reports/

The information is such information that Immunicum is obliged to make public pursuant to the EU Market Abuse Regulation. The information was released for public disclosure through the agency of the company's contact person on May 19, 2017 at 08.00 CET.

Financial Calendar

Interim Report Q2 2017: 18 August 2017

Interim Report Q3 2017: 17 November 2017

Year-end report 2017: 16 February 2018

For more 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

Investor and Media Relations EU/US

MacDougall Biomedical Communications
Gretchen Schweitzer or Joanne Tudorica
Telephone: +49 89 2424 3494 or + 49 172 861 8540
E-mail: gschweitzer@macbiocom.com or jtudorica@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 clinical stage Company developing novel immuno-oncology therapies against a range of solid tumors. The Company's lead compound, INTUVAX® is currently being evaluated in clinical trials for the treatment of kidney cancer, liver cancer and gastrointestinal stromal tumors. INTUVAX® was designed to combine the best of two worlds: a cost-effective cell-based (allogeneic) and off-the-shelf therapy that is capable of triggering a highly personalized and potentially long-lasting immune response against tumor cells throughout the body. www.immunicum.com

 

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