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Friday, 17 November 2017

Immunicum AB (publ): Interim Report Q3 - Corporate Update and Outlook

Immunicum AB    

Published: 08:00 CET 17-11-2017 /GlobeNewswire /Source: Immunicum AB / : IMMU /ISIN: SE0005003654

Immunicum AB (publ): Interim Report Q3 - Corporate Update and Outlook

Press Release

17 November 2017

Immunicum AB (publ): Interim Report Q3 - Corporate Update and Outlook

Immunicum AB (publ; First North Premier: IMMU.ST) a biopharmaceutical company advancing an off-the-shelf immune system primer against a range of solid tumors, today announced its financial results and a corporate update for the third quarter 2017.

CEO Comment - Third quarter

Our vision as a Company is to advance ilixadencel as a novel therapy for the treatment of solid tumors and to continue the strategic development of our pipeline to build long-term value for our shareholders. This past quarter and the weeks up until this report have been particularly exciting because we have achieved several scientific and clinical milestones and initiated a financial transaction to support our vision and long-term success.

Most importantly, we completed the HCC Phase I/II clinical study with positive safety and tolerability results as well as encouraging immune system activation data. Beyond the positive clinical data, we were pleased to announce the presentation of preclinical ilixadencel mode of action data at the Society for Immunotherapy of Cancer (SITC) 32nd Annual Meeting .

Looking forward, we have announced with our Board of Directors a Rights Issue that will support the ongoing operations and allow the Company to implement the next phase of our updated clinical development plan. We designed this plan with a clear focus on increasing the opportunities for ilixadencel in the evolving cancer therapeutic landscape based on its applicability in a variety of solid tumors, its potential synergistic effects with other cancer therapies and its encouraging safety profile. In order to minimize shareholder dilution while maximizing value creation for the Company and ilixadencel, Immunicum's management and board made the decision to finance the plan in stages. The secured proceeds from the announced Rights Issue will ensure that the Company and its ongoing projects are fully financed until completion in 2019, while also providing valuable data in combination with checkpoint inhibitors in three interesting new indications, advancing ilixadencel's potential on multiple fronts. While we still believe that HCC represents a very attractive indication where ilixadencel could make a significant impact to existing treatment, we also believe that it is important for the Company to reach its key value inflection points. Therefore, we will stay focused on achieving those milestones in the near-term and remain open to strategic options that could support a Phase II trial in HCC. The proceeds from the announced Rights Issue will allow us to concentrate on fulfilling ilixadencel's potential in multiple indications and combinations, while simultaneously taking the Company to the next stage of its development. Speaking for the management team, all of whom will participate in the Rights Issue, and as a company, we are committed to the opportunity before us to build value for our shareholders and bring innovative treatments to patients. 

Carlos de Sousa

President and CEO

Significant events during the third quarter

  • The first patient was enrolled in the United States (US) as part of the Company's ongoing global Phase II MERECA (MEtastatic REnal Cell CArcinoma) trial. This continues the expansion of Immunicum's clinical program to realize ilixadencel's potential and to execute a global clinical trial including meeting all regulatory and manufacturing requirements in the US which are significant for a cell-based therapy.
  • The Company announced the last patient last visit in the ongoing Phase I/II study of ilixadencel in hepatocellular carcinoma (HCC). The open label study enrolled eighteen patients and was conducted at the Sahlgrenska University Hospital at Gothenburg University. Positive topline results from the study were announced end of September. Ilixadencel was shown to be safe and well tolerated in these patients when given both as a single treatment and in combination with the current first line standard of care treatment, sorafenib. In addition, the results provide evidence of tumor-specific immune activation in the majority of patients.
  • Immunicum's leadership team, together with its Board of Directors and external advisors, completed a strategic review process to define the next phase of ilixadencel's clinical development program. The review process was initiated in the beginning of 2017 to evaluate the current therapeutic landscape and ensure that the Company's clinical development efforts are positioned to realize ilixadencel's full potential.

Significant events after end of period

  • Sharon Longhurst was appointed as Head of Chemistry, Manufacturing and Controls (CMC). She will support Immunicum's objective to develop a commercially-ready manufacturing process for lead product, ilixadencel.
  • The Company announced that Immunicum's Board of Directors resolved on a new issue of shares which will result in total proceeds of approxmately SEK 223 million before transaction costs, assuming the new share issue is fully subscribed. A guarantee consortium has, subject to certain conditions, undertaken to subscribe for new shares to such extent that the new share issue is secured up to SEK 200 million. The new Rights Issue with preferential rights for existing shareholders (the "Rights Issue") is subject to subsequent approval of an extraordinary general meeting.
  • Ilixadencel mode of action data was presented at the Society for Immunotherapy of Cancer (SITC) 32nd Annual Meeting. The preclinical results show how ilixadencel induces several complementary immunological processes that are needed in order to prime the immune system to recognize and destroy cancer cells.
  • Immunicum announced two online publications of preclinical studies investigating the mode of action of ilixadencel in the prestigious scientific journal Oncoimmunology. The studies show the multiple ways in which ilixadencel, or corresponding allogeneic proinflammatory mouse dendritic cells, create an immune-priming environment.

Financial Summary

Third quarter (July-September) 2017 compared with the same period in 2016

  • The operating loss amounted to TSEK -21,597 (TSEK -12,018)
  • Net loss amounted to TSEK -21,659 (TSEK -11,985)
  • Earnings per share before and after dilution amounted to SEK -0.83 (SEK -0.46)

The period January-September 2017 compared with the same period in 2016

  • The operating loss amounted to TSEK -61,245 (TSEK -36,614)
  • Net loss amounted to TSEK -61,512 (TSEK-36,614)
  • Earnings per share before and after dilution amounted to SEK -2.37 (SEK -1.65)
  • Cash and cash equivalents plus funds invested in mutual fund amounted to TSEK 53,112 at 30 September 2017 (TSEK 129,032)
  • Shareholders' equity per share amounted to SEK 1.57 (SEK 4.90)
  • Number of employees at the end of the period was 10 (9)

 

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 November 17, 2017 at 08.00 CET.

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: ir@immunicum.com

Investor and Media Relations EU/US

MacDougall Biomedical Communications

Joanne Tudorica

Telephone: +49 89 2424 3494

E-mail: ir@immunicum.com

 

 

The Company's Certified Adviser is Redeye AB

Telephone: +46 (0)8 545 013 30

www.redeye.se

 

 

About Immunicum AB (publ)

Immunicum is establishing a unique immuno-oncology approach through the development of allogeneic, off-the-shelf cell-based therapies. Our goal is to improve survival outcomes and quality of life by priming the patient's own immune system to fight cancer. The company's lead product ilixadencel, consisting of pro-inflammatory allogeneic dendritic cells, has the potential to become a backbone component of modern cancer combination treatments in a variety of solid tumor indications. Founded and based in Sweden, Immunicum is publicly traded on the Nasdaq First North Premier. www.immunicum.com

 

 

 



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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 Corporate Solutions clients. Source: Immunicum AB, Grafiska vägen 2, Gothenburg SE-412 63, Sweden
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