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CELLMED & PROCURE®: AT A GLANCE

  • CELLMED Research GmbH1:
    Austrian life science company founded in 2006
  • CLINICAL COMPANY:
    Phase I/IIa in ovarian cancer successfully completed and phase IIb coming up
  • PROCURE®:
    Patented unique double loaded dendritic cell therapy maximizing magnitude of efficacy directly activating both arms of the immune system without restrictions proven by striking phase I/IIa results
    - Highly significant immune responses in 100% of patients treated
    - Cancer recurrence delayed by 100% compared to control (interim data)
  • SUPERIOR TARGETS:
    Two universal tumor antigens Survivin & TERT, pivotal for development of most tumor types
    - Maximize efficacy, minimize side effects
    - Platform technology for a broad spectrum of therapeutic indications
  • MANUFACTURING:
    Robust and of reproducible high quality with off the shelf antigens and potency release assay
  • COMMERCIALIZATION:
    Automation concept ready for scale up
  •  IN-HOUSE:
    Production technology, logistics, distribution and management competence

CELLMED’S MISSION: THE APPROVAL OF PROCURE®

CELLMED is reshaping the future of cancer treatment by focusing on the clinical development of its lead product PROCURE®. By supporting the rise of personalized medicine and cellular immunotherapy CELLMED aims to provide a better treatment for patients.

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CELLMED board of directors

  • Gerhard Huber
  • Gerhard Nidetzky
  • Rudolf Zelenka
  • Thomas Zivny

Cellmed's Technology

PROCURE® is a vaccine manufactured from cells isolated from the individual patient. Precursor cells collected from the patient via leukapheresis are differentiated into dendritic cells, loaded with two universal tumor antigens, TERT mRNA and Survivin peptide, via the MHC I & II pathways. This unique dual antigen loading technology of PROCURE® is designed to elicit both short- and long-term anti-tumor immune responses and targets two fundamental and well characterized structures essential for tumor progression and development.

After passing stringent release criteria at the GMP laboratories, PROCURE® is stored frozen until the thawed vaccines are administered intradermally to the patient, in compliance with a pre-defined treatment scheme. CELLMED’s innovative cellular immunotherapy represents a technology platform applicable for the treatment of all solid tumors in general. Besides targeting ovarian cancer PROCURE® can be developed in additional cancer indications with potential for further pipeline products.

Cell life for long life

Development Plan

A phase I/IIa study with 15 patients randomized in two treatment arms to confirm the safety and immunological proof of concept of PROCURE® was conducted with last patient out in December 2012 and final report in June 2013. All results of the phase I/IIa trial confirmed product safety and results of specific T cell responses of all evaluable patients exhibit a striking 100% rate of positive immune responses with high significance1.

The median of progression free survival (PFS) as of February 2014 is already 14.5 months longer (interim data) which means a 100% improvement compared to the historical control group. Further data will be collected. It should be noted that Avastin, an angiogenesis inhibitor for the treatment of cancer, has received the EU approval based on results of two studies with improvement in PFS in the range of 14%-39% though substantial side effects.

Market and Competitors

Cancer is one of the leading causes of death in the industrialized world and one of the most prominent areas of research and development in the pharmaceutical industry. Certain cancers cannot be cured and improvements based on new therapies mostly focus on overall survival, often neglecting the patient ́s quality of life.

Today’s demography and modern way of life have led to a significant increase of cancer. In the EU alone, 2.7 million new cases of cancer are diagnosed annually. Cancer product sales constitute a USD 77bn market, in which CELLMED is positioning itself with its immunotherapy technology.

Considerable market potential in solid tumor indications

GLOBAL CANCER INCIDENCE IN ‘000

  • 48,0 % Asia
  • 24,5 % Europe
  • 20,5 % America
  • 6,0 % Africa
  • 1,0 % Australia / New Zealand

Structure and Team

CELLMED was founded in 2006. Today the CELLMED-group consists of the subsidiaries Life Research Technologies GmbH and Cellpro Danube GmbH. Currently the consolidation and simplification of the corporate structure are in progress.
structureandteam_1 structureandteam_2structureandteam_3 structureandteam_4structureandteam_5

Financial Planning

Up to now, CELLMED has raised more than EUR 16.9 million for its project. Now CELLMED is aiming for a EUR 5.0 million equity round for its clinical phase IIb study. Proof of concept in phase IIb data should lead to the exit point (M&A or IPO) within around 3.5 years after funding.

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Exit strategy

It is the clear objective of the present shareholders as well as the management team to prove efficacy of PROCURE® in ovarian cancer. In case of success, the product should preferably be sold or licensed out to big pharma. If the market environment is favorable at this point of time, an IPO could be seen as an alternative exit scenario, should the value of the company not be achievable in an M&A transaction according to plan.

Investment Considerations and Risk Factors

The investor shall thoroughly evaluate the following risk factors and considerations.

Cell life for good life

Letter from the CEO

letterfromtheceo_1

Dear Investor!

In 2006 a group of scientists, medical doctors and investors were inspired by the vision to develop a cellular immunotherapy against cancer and founded CELLMED, a biotech company focusing on oncological cell therapy. To find a cancer therapy that would support the human body's own defense mechanisms against cancer and would not cause such severe side effects, usually associated with cancer therapy, seemed a goal to invest eight years of hard work and EUR 16.9 million thus far.

 

Contact

CELLMED Research GmbH

Schönlaterngasse 11/13
1010 Wien
AUSTRIA

office@cellmed.at
www.cellmed.at

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