Quarterly Report
Zug, Switzerland
2015
Q1
Quarterly Report Q1/2015
AmVac at a glance
AmVac AG is a biopharmaceutical company developing and marketing innovative vaccines. The life-science company was
founded in 2005, is headquartered in Zug, Switzerland and has research laboratories in Germany and Italy, and a
manufacturing operation in Hungary. Based on exclusive licenses from leading German scientific institutes of the
Helmholtz- and Max-Planck societies and own acquired IP, AmVac has developed an innovative portfolio of seven vaccine
candidates and three platform technologies – Lactobacillus, Sendai and Malp. The most advanced product of AmVac is
Gynevac, based on the Lactobacillus platform. Previously already approved for selected indications in certain geographies,
the product is currently being developed for the treatment of certain highly prevalent urogenital diseases on a broad
international level. With its particularly favourable safety profile, Gynevac could, for the first time, offer an effective
treatment or prevention of non-malignant prostate enlargement and inflammation and bacterial, virtually free of side
effects. Lastly, AmVac is currently directing a part of its research program to a promising Ebola vaccine in its pipeline.
Dear Shareholder
We are pleased with the development in the first quarter of 2015. As announced on March 10, 2015, the Board of Directors
has appointed Dr. Ali Pashazadeh as acting Chief Executive Officer of AmVac AG. Ali Pashazadeh is the founder of Treehill
Partners, an execution-focused consultancy and interim management firm led by four seasoned healthcare professionals
focused on the hands-on support of international companies in the Biopharma space. Prior to founding Treehill Partners,
Ali Pashazadeh held senior healthcare advisory positions at Blackstone, UBS and Goldman Sachs. He is a trained
surgeon, holding an MBBS and BSc from St Mary’s Hospital Medical School, London as well as an MBA from London
Business School. Ali Pashazadeh has taken over operating management responsibilities from company founder Melinda
Karpati who will continue to make her expertise available to AmVac through chairmanship of the Scientific Committee of
the Board of Directors.
“As over the last years key decisions have been taken and foundations been laid, the transition in AmVac’s management is
the logical next step in the development of our company”, commented Melinda Karpati. The Board of Directors expressed
its gratitude for her achievements in leading AmVac and is looking forward to the continuing collaboration.
As parts of its strategic review, AmVac is currently considering all of its strategic and financing options which may include
the launching of financial instruments to strengthen its balance sheet.
AmVac's product pipeline
Lactobacillus Platform
Gynevac
Enrolment into the Gynevac trial in Bacterial Vaginosis continues in Hungary and is currently on track to complete its phase
III study by the end of this year.
Sendai Vector Platform
RSV
Following promising results in mice, AmVac is in the process of preparing for initial experiments in non-human primates.
Should the positive efficacy observed in small animals be repeated in primates, this would provide a key indicator for
future strategic decisions regarding the development of our RSV vaccine candidate.
AmVac AG / Baarerstrasse 22 / 6300 Zug / Switzerland / www.amvac.eu / Tel. +41 41 725 32 30 / Fax +41 41 725 32 39
Quarterly Report Q1/2015
In such a case, the next step would be to conduct a full preclinical non-human primate study as basis for submission of a
dossier to the authorities applying for approval to enter into phase I clinical studies.
Further key preclinical steps including toxicology studies as well as designing a high quality manufacturing process could
then also be initiated.
Ebola
AmVac has started development of a vaccine candidate against Ebola in the last quarter of 2014. Since then a set of
potential product candidates have successfully been designed in-vitro.
Candidate selection is currently ongoing in order to refine and determine one or more suitable product candidates for
initial experiments in small animals. This process includes, for example, establishing whether a product candidate can be
produced on a scale sufficient for preclinical animal experiments.
MALP-2 Platform
Influenza
Preclinical work in form of initial small animal experiments on our two adjuvanted vaccine candidates for the prevention of
seasonal influenza (AMV401) and for the prevention of pandemic influenza (AMV411) have been continued during the first
quarter of 2015.
Cancer
In Q1 AMVAC also announced that it had licensed additional rights under the MALP-2 platform which cover the
development of the platform for the treatment of cancers. A MALP-2 adjuvanted vaccine was used in pancreatic cancer
in a 2007 Phase I/II study run by University Hospital Heidelberg with encouraging results.
Grants Projects
AmVac has continued its collaborations with its partners under the two major grant programs UniVax (universal influenza
vaccine) and MuLeVaClin (vaccine against Leishmaniasis).
This is an exciting time for our Company. We have made significant progress striving for operational optimization by
focusing on our key value drivers and strengthening our management team. Thus we look at the future with continued
optimism, and last but not least we thank our employees and partners for their dedication and our shareholders for their
valuable support.
Zug, May 4, 2015
Marie-Christine Kopkow
Chairwoman of the Board
Dr. Ali Pashazadeh
Chief Executive Officer
AmVac AG / Baarerstrasse 22 / 6300 Zug / Switzerland / www.amvac.eu / Tel. +41 41 725 32 30 / Fax +41 41 725 32 39