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Friday, 17 February 2017

Immunicum AB: Year-End Report 2016 (July 2016 - December 2016)

Immunicum AB    

Published: 07:30 CET 17-02-2017 /GlobeNewswire /Source: Immunicum AB / : IMMU /ISIN: SE0005003654

Immunicum AB: Year-End Report 2016 (July 2016 - December 2016)

GOTHENBURG, Sweden, February 17, 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 financial results for the year ended December 31, 2016 and provided a corporate update and overview of the Company's activities. Carlos de Sousa, MD, CEO of Immunicum, will conduct a webcast and conference call to present the update today at 10:00 am CET. Information for joining the webcast and call are listed at the end of this press release.

 

Significant events during the second quarter year

 

On October 26, 2016, the Annual General Meeting ("AGM") of Immunicum AB elected Steven Glazer, Charlotte Edenius and Kerstin Valinder Strinnholm as new Board members. Agneta Edberg, Martin Lindström, Magnus Nilsson and Magnus Persson were all re-elected as Board members. Bengt Furberg declined re-election. Agneta Edberg was re-elected as Chairman of the Board.

 

The AGM also resolved to authorize the Board of Directors to, on one or several occasions during the period until the next Annual General Meeting, with or without deviation from the shareholder's preferential rights, resolve on new share issues of a maximum of 5,040,000 shares.

 

AGM also resolved to change the fiscal year of the Company to calendar year as well as to shorten the current fiscal year to cover the period July 1, 2016 - December 31, 2016.

 

On November 14, 2016, at the Society for Immunotherapy of Cancer (SITC) 31st Annual Meeting, Immunicum presented updated immunological and survival phase I/II data on hepatocellular carcinoma (HCC) patients treated with INTUVAX®. Data showed that 67% of fully treated patients with advanced HCC experienced increases in circulating tumor-specific CD8+ T cells and that these increases appear to correlate with prolonged survival rates seen in the study as compared to historical median overall survival rates. It was furthermore announced that all six additional patients in an extension of the study had been included. These patients received INTUVAX® as first line systemic treatment in combination with standard treatments.

 

On December 13, 2016, Immunicum announced that the United States Food and Drug Administration (FDA) had cleared the Company's Investigational New Drug application (IND) for INTUVAX®. The IND clearance enables Immunicum to expand its ongoing phase II study - MERECA (MEtastatic REnal Cell CArcinoma) - for the treatment of metastatic renal cell cancer patients, into the United States.

 

Significant events after the financial year

 

In February 2017, the Company announced the appointment of Karin Hoogendoorn as Head of Chemistry Manufacturing and Controls (CMC). Dr. Hoogendoorn is a seasoned expert in the development of biotechnological products and has lead successful CMC efforts for a variety of products within positions at Novartis AG, Janssen Biologics BV and Crucell Holland and will be critical for the high quality production of Immunicum's products.

 

In February 2017, the Company announced that the Agence Nationale de Sécurité du Médicament et des Produits de Santé (ANSM) in France has 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.

 

Financials

 

Second quarter (October-December) 2016 compared with the same period in 2015

  • Operating profit/loss amounted to TSEK -24,719 (TSEK -11,227)
  • Net profit/loss amounted to TSEK -24,809 (TSEK -11,478)
  • Earnings per share before and after dilution (weighted average) amounted to SEK -0.96 (SEK -0.57)

 

Financial year (July-December) 2016 compared with the same period in 2015

  • Operating profit/loss amounted to TSEK -36,737 (TSEK -19,047)
  • Net profit/loss amounted to TSEK -36,794 (TSEK -19,294)
  • Earnings per share before and after dilution (weighted average) amounted to SEK -1.42 (SEK -0.96)
  • Liquid funds and unit trust/mutual fund investments amounted to TSEK 112,425
  • (TSEK 53,106) at 31 December 2016
  • Shareholders' equity per share amounted to SEK 3.94 (SEK 2.26)
  • Number of employees at the end of the period 11 (7)

 

CEO Statement

 

It is an exciting moment for Immunicum as we prepare for a transformative year in 2017. In addition to advancing our ongoing clinical trials for INTUVAX® and strengthening our leadership team at Immunicum, we continue to refine our near-term objectives for the overall development of our programs and to review all the Company's activities to ensure that we have the right team, right resources and right focus in place to build the most value for our investors. 

 

Since the Company's inception, Immunicum has achieved the clinical stage development of a promising immuno-oncology therapeutic approach for treating a range of solid tumors. It is a major achievement for a small organization like Immunicum to bring a discovery into multiple clinical trials. It goes without saying that immuno-oncology is one of the most exciting areas of pharmaceutical discovery and development, with the first approved drugs proving the value of the concept that a key way to fight cancer is to re-activate the patient's own immune system to destroy cancerous cells. Immunicum has a unique approach to immune-oncology and we believe that it has the potential to become an important part of treating solid tumors in the future. Our strategy remains to advance our programs successfully into the clinic and ensure the success of these trials. 

 

The following is an overview of the most up-to-date information from the INTUVAX® trials in kidney and liver cancer as well as GIST (gastrointestinal stromal tumor). 

 

Renal Cell Carcinoma (RCC): 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, has been implemented across Europe. To date, a total of 43 patients have been enrolled at 18 centers in seven European countries. The primary purpose of the MERECA trial is to examine safety as well as clinical benefit in terms of survival rate at 18 months and median overall survival for all patients. The Company will also study the objective tumor response after initiating treatment with sunitinib, as well as study intratumoral infiltration of CD8+ T cells. 

 

In the context of this open-label trial, we can report that safety remains positive and that levels of infiltration are in line with what we have seen previously, however, it is still too early to make any further interpretation of data. We will present all these data as well as those from the continued follow-up of the patients from the phase I/II trial in RCC in due course at scientific conferences and in peer-reviewed scientific journals. 

 

We announced in December that our Investigational New Drug (IND) application to the Food and Drug Administration (FDA) has been cleared to start enrolling kidney cancer patients in the U.S. as part of the MERECA trial. We anticipate to start this process in the second quarter of 2017.

 

To support this goal, we have optimized the production of the product at a large manufacturing facility in Germany. This has been a positive development for the ongoing trial in EU as well as our preparation for the start of the enrollment in the US. 

 

Hepatocellular Carcinoma (HCC): In November 2016 we provided updated immunological and survival data from our clinical phase I/II study in patients with advanced hepatocellular carcinoma which were presented at the Society for Immunotherapy of Cancer's (SITC) annual meeting. The data showed that 67% of fully treated patients with advanced HCC experienced increases in circulating tumor-specific CD8+ T cells. These increases appear to correlate with the prolonged survival rates seen in the study as compared to historical median overall survival rates. In the extension of the study we have now enrolled the last of the six additional liver cancer patients that received INTUVAX® concomitantly with first line standard of care medication. 

 

Gastrointestinal Stromal Tumors (GIST): As previously reported, the first patient has been included in our clinical phase I/II study with INTUVAX® in patients with GIST. Because the disease is both rare and complex, we have revised the study protocol in collaboration with the investigators at the Karolinska Institute, and this protocol has been reviewed and approved by the National Authorities and Ethical committee. 

 

Clinical Development Plan Analysis: The important information that we will gain from these ongoing trials will complement our ongoing analysis of the cancer treatment landscape to determine the most successful path for INTUVAX®. The most critical decisions here involve considering which indications we should select for the later stage clinical development of the program. There are several aspects to consider: patient need, clinical endpoints for the trial and overall success potential for regulatory approval. Over the last several months, we have considered the possibility of expanding the development plan with additional phase I/ II studies in different indications, such as melanoma, and in different combinations, e.g. with immune checkpoint inhibitors. These considerations are still underway and we look forward to providing an update on them in the near future. 


Development Programs and Academic Collaborations: Immunicum's major focus is to advance the ongoing clinical studies with INTUVAX®, however, we will continue to invest into deeper investigation of two of our earlier stage applications: CD70 and the adenovirus vector program, where the development is conducted in collaboration with professor Magnus Essand at Uppsala University. For CD70, we are currently evaluating the possibilities for clinical production and for the vector, we are currently conducting preclinical studies within the concept of SUBCUVAX. These efforts will allow us to build additional value from the research conducted to date. 

 

Corporate and Organizational Updates: We had the pleasure of announcing the addition of Karin Hoogendoorn as Head of CMC. We will continue to strengthen our leadership team with expertise in product development and production, regulatory strategy and business development to reinforce the strength of the current leadership and build a company well-positioned to succeed. 

 

Ongoing Communications Activities: We will continue to place a focus on providing regular updates to our shareholders as well as raising the profile of the Company both through industry and financial events as well as scientific and medical conferences. We will be announcing our participation in conferences in Sweden, Europe and in the US on a more frequent basis. 

 

Our vision for the Company is to increase our interaction within the larger biopharmaceutical industry while maintaining our operational focus on the further development of our programs. 

 

Carlos de Sousa
CEO

 

 

 

Webcast and conference call information:

 

Date: Friday, February 17, 2017

Time: 10:00 am CET

http://beta.redeye.se/live/immunicum

 

 

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

 

 

For more information, please contact

Carlos de Sousa, CEO, Immunicum

Ph: +46 (0) 31 41 50 52
E-mail:
info@immunicum.com

 

 

Media Contact

MacDougall Biomedical Communications

Gretchen Schweitzer or Stephanie May

Ph: +49 89 2424 3494 or + 49 175 571 1562

E-mail: gschweitzer@macbiocom.com

 

The company's Certified Adviser is Redeye AB

Ph: + 46 8 545 013 31

www.redeye.se

 

The information in this press release is disclosed pursuant to the EU Market Abuse Regulation. The information was released for public disclosure through the agency of the company's contact person on February 17, 2017 at 7:30 CET



Year-End Report 2016



This announcement is distributed by Nasdaq Corporate Solutions (One Liberty Plaza, 165 Broadway, New York, NY 10006. Tel: +1 212 401 8700. www.nasdaqomx.com) on behalf of NASDAQ OMX Corporate Solutions clients. Source: Immunicum AB, Grafiska vägen 2, Gothenburg SE-412 63, Sweden
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