Ventaleon GmbH reports clear clinical progress and additions to the Supervisory Board

  • Last participant enters human challenge trial, data expected by year end 2017
  • New Supervisory Board members and investment

Gemuenden, Germany, 12 October, 2017 – Ventaleon GmbH, a biotechnology company focusing on the development of inhaled treatments against viral infections, provided today a clinical and corporate update following an extraordinary shareholder meeting. The update includes details on the strong clinical progress the Company has made in the last two quarters as well as news on the Supervisory Board and a new investor.

In the clinic, Ventaleon recently signed up the last participant to the challenge trial (see, Ventaleon GmbH Initiates Challenge Trial with Inhaled Flu Treatment Candidate), which is testing an inhaled formulation of LASAG (D,L-lysine acetylsalicylate • glycine), in volunteers infected with the H3N2 subtype of the influenza A virus. Since May end, the trial has recruited over 80 volunteers.

Dr. Ulrich Dauer, CEO of Ventaleon GmbH, noted, “We are comfortably on track to expect topline results by year end 2017. The challenge trial has been designed specifically to show the causal effect of LASAG inhalation on the influenza virus and will be an important step in preparing the pivotal trials.”

On the Supervisory Board, Ventaleon has appointed Dr. Gonzalo de Miquel, Chief Medical Officer & Executive Vice President Development with Vectura Group plc, to the company’s Board. Prior to joining Vectura, Dr. de Miquel was Vice President of Clinical Development at Astra Zeneca and Head of the AZ Center of Respiratory Medicine in Barcelona (Catalonia, Spain) with responsibilities on the overall strategy, organization, resource assignment and project prioritization across Astra Zeneca’s respiratory portfolio. Dr. de Miquel held other senior positions such as Senior Director of Global Clinical Development at Almirall (Spain) where he was responsible of all early clinical and late-stage developments, and successfully led the aclidinium monotherapy franchise development throughout from early clinical to FDA and EMA submissions and approvals in 2012, and the aclidinium/formoterol approval by EMA in 2014. Dr. de Miquel was previously Head of Respiratory at Boehringer Ingelheim (Spain) working through the late stage development and the launch of tiotropum (Spiriva® Handihaler®) in Spain.

Also, appointed as a member of the Supervisory Board is Dr. Gerhard Scheuch, founder and former CEO of Ventaleon. Also, he was founder and CEO of Activaero, a drug development company that was acquired by Vectura Group in 2014. Formerly, Dr. Scheuch was founder of Inamed, a CRO specialized in the field of respiratory diseases. He is also involved in different pharmaceutical developments involving inhalation therapy and serves on scientific advisory boards of several big Pharma companies. Dr. Scheuch is a regulatory expert at EMA and former President of The International Society of Aerosols in Medicine (ISAM).

Dr. Scheuch substantially expanded his shareholding by a recent investment in the Company.

“With Dr. Gonzalo de Miquel and Dr. Gerhard Scheuch joining the Supervisory Board Ventaleon’s future will be further defined by two masters of the early and late stage clinical development environment for pulmonary technologies and therapies,” said Dr. Jean Lüchinger, Chairman of the Supervisory Board. “Furthermore, the joint knowledge and experience of these gentlemen will ensure the most efficient path through the regulatory approval process. We are also very pleased to welcome Dr. Scheuch as an investor in the Company.”

The new Supervisory Board includes the following members, all representing Ventaleon shareholders: Dr. Jean Lüchinger, Abalis Finance AG (Chairman); Dr. Arnd Kaltofen, VI Partners; Dr. Karsten Fischer, BioMed Partners; Dr. Christian Schneider, Vesalius Biocapital Partners; Dr. Jörg Neermann, LSP; Dr. Gonzalo de Miquel, Vectura; and Dr. Gerhard Scheuch. 

For further information, please contact:
Contact
Ventaleon GmbH
Dr. Ulrich Dauer, CEO
Tel.: +49-6453-58530-40
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Media Inquiries
MC Services AG
Julia von Hummel
Tel: +49 89 210228 34
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About Ventaleon GmbH: www.ventaleon.com

Ventaleon GmbH is a biotechnology company focused on the development of inhaled treatments against viral infections. The Company’s lead therapy candidate is an inhaled form of LASAG (D,L-lysine acetylsalicylate • glycine), which it is developing to treat severe influenza. A proof-of-concept study in influenza patients with moderate to severe symptoms demonstrated more rapid symptom decline when administered inhaled LASAG compared to standard of care. The Company is currently preparing to enter a pivotal clinical trial with inhaled LASAG. Ventaleon was founded as a spin-off from Activaero and is supported by a group of leading international investors, including Coöperatief LSP U.A., BioMedInvest II LP, Abalis Finance AG, Vesalius Biocapital I S.A., Venture Incubator AG, CatheyWorldInvestment Ltd. and BayBg as well as Vectura plc., Dr. Scheuch and other private investors.

Ventaleon founder Dr. Gerhard Scheuch receives Juraj Ferin Award 2017 for outstanding contributions to the International Society for Aerosols in Medicine

Gemuenden, Germany, June 14, 2017– Ventaleon GmbH, a biotechnology company focusing
on the development of inhaled treatments against viral infections, is pleased to congratulate
Dr. Gerhard Scheuch, who has received the Juraj Ferin Award 2017 for his outstanding
contributions to the International Society for Aerosols in Medicine (ISAM). The award was
presented on June 4, 2017 at the 21st ISAM Congress in Santa Fe, New Mexico, USA.

Dr. Scheuch is an internationally recognized expert in pulmonary drug delivery, inhalation
products as well as respiratory diseases and served as ISAM president from 2007 through 2013.
Dr. Scheuch founded Ventaleon in 2012 and was CEO until stepping down earlier this year but
will continue to serve as a member of the Supervisory Board of Ventaleon. He was founder and
CEO of Activaero as well as of Inamed, both companies dedicated to developing inhalation
technologies and therapies, and also served as chief scientific officer at Vectura group plc after
their acquisition of Activaero. He holds a PhD in physics from the Wolfgang Goethe University
Frankfurt (Germany).

For further information, please contact:

Contact
Ventaleon GmbH
Dr. Ulrich Dauer, CEO
Tel.: +49 6453 58530 40
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Media Inquiries
MC Services AG
Katja Arnold, Dr. Brigitte Keller
Tel: +49 89 21022 0
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About Ventaleon GmbH: www.ventaleon.com

Ventaleon GmbH is a biotechnology company focused on the development of inhaled
treatments against viral infections. The Company’s lead therapy candidate is an inhaled form
of LASAG (D,L-lysine acetylsalicylate • glycine), which it is developing to treat severe influenza.
A proof-of-concept study in influenza patients with moderate to severe symptoms
demonstrated more rapid symptom decline when administered inhaled LASAG compared to
standard of care. The Company is currently preparing to enter a pivotal clinical trial with inhaled
LASAG. Ventaleon was founded as a spin-off from Activaero and is supported by a group of
leading international investors, including Coöperatief LSP U.A,, BioMedInvest II LP, Abalis
Finance AG, Vesalius Biocapital I S.A., Venture Incubator AG, CatheyWorldInvestment Ltd. and
BayBg.

Ventaleon presents Phase II results with inhaled LASAG in severe influenza at ISAM Congress 2017

  • Study evaluated efficacy and safety of inhaled LASAG for treatment of severe
    influenza in hospitalized patients compared to standard of care treatment alone
  • Significant reduction in time to alleviation of symptoms and of clinical signs
  • No significant safety differences between LASAG and placebo

Gemuenden, Germany, 07 June, 2017 – Ventaleon GmbH, a biotechnology company
focusing on the development of inhaled treatments against viral infections, today presented
data from its Phase II trial with inhaled LASAG (D,L-lysine acetylsalicylate
glycine) in severe
influenza at the 21
st Congress of the International Society for Aerosols in Medicine (ISAM)
being held in Santa Fe, NM, USA. LASAG, a compound with a novel antiviral mode of action,
has been shown to inhibit the signaling factor NF-
B that is essential for the replication of
influenza viruses. This is believed to be the first time that a host-cell signalling inhibitor with an
off-virus effect demonstrated efficacy as an antiviral drug.

Prof. Dr. Oliver Planz, Head of the group “Translational Immunology of Infection” in the
Department of Immunology of University of Tuebingen, Germany., and co-author of the
study, said: “Therapeutic intervention strategies against severe, hospitalized influenza are
limited. The data presented at ISAM support that inhaled LASAG in addition to standard of
care has the potential to significantly reduce time to alleviation of symptoms in hospitalized
patients with severe influenza. I look forward to this treatment being evaluated in larger clinical
studies.”

“We are excited with the results presented for inhaled LASAG in patients with severe influenza,
as they clearly support advancing this program in development,” said Dr. Ulrich Dauer, CEO
of Ventaleon. “We just initiated a Phase Ib challenge study to show the causal effect of LASAG
inhalation on the influenza virus, which is an important step in preparing for pivotal trials.”

The randomized, double-blind, placebo-controlled Phase II clinical trial evaluated aerosolized
LASAG compared to placebo for the treatment of severe influenza (as shown by composite
symptom scores (CSS) ≥14). In addition to standard of care treatment, inhaled LASAG or
placebo were administered three times daily in adult hospitalized patients with acute serious
influenza. A total of 41 patients (LASAG: n=24; placebo: n=17) completed the study per
protocol.

The primary endpoint of the study was time to alleviation of clinical influenza symptoms. The
LASAG group showed significantly reduced time to alleviation of symptoms compared to
placebo (38.3 hrs vs. 56.2 hrs; Satterthwaite t-test p=0.0365). The secondary endpoint of
alleviation of clinical signs (including body temperature and oxygen saturation) was also
significantly improved in the LASAG group compared to placebo (24.9 hrs vs. 44.1 hrs; onesided t-test p=0.00246).

LASAG was generally well tolerated with no significant safety differences between the LASAG
and placebo groups. Based on the data of this Phase II study together with results from the
ongoing Phase Ib challenge trial expected towards year end, Ventaleon will define its pivotal
development strategy for this first in class product candidate for severe hospitalized influenza
and explore the potential to extend the inhaled LASAG therapy to a broader patient base
suffering from viral infections.

For further information, please contact:

Contact
Ventaleon GmbH
Dr. Ulrich Dauer, CEO
Tel.: +49-6453-58530-40
E-Mail: Diese E-Mail-Adresse ist vor Spambots geschützt! Zur Anzeige muss JavaScript eingeschaltet sein!

Media Inquiries
MC Services AG
Katja Arnold, Dr. Brigitte Keller
Tel: +49 89 21022 0
E-Mail: Diese E-Mail-Adresse ist vor Spambots geschützt! Zur Anzeige muss JavaScript eingeschaltet sein!

About Ventaleon GmbH: www.ventaleon.com

Ventaleon GmbH is a biotechnology company focused on the development of inhaled
treatments against viral infections. The Company’s lead therapy candidate is an inhaled form
of LASAG (D,L-lysine acetylsalicylate‧ glycine), which it is developing to treat severe influenza.
A proof-of-concept study in influenza patients with moderate to severe symptoms
demonstrated more rapid symptom decline when administered inhaled LASAG compared to
standard of care. The Company is currently preparing to enter a pivotal clinical trial with inhaled
LASAG. Ventaleon was founded as a spin-off from Activaero and is supported by a group of
leading international investors, including Coöperatief LSP U.A,, BioMedInvest II LP, Abalis
Finance AG, Vesalius Biocapital I S.A., Venture Incubator AG, CatheyWorldInvestment Ltd.
and BayBg

Ventaleon GmbH Initiates Challenge Trial with Inhaled Flu Treatment Candidate

  • Human challenge study to assess safety, tolerability and efficacy of inhaled LASAG
  • Topline results expected end of 2017

Gemuenden, Germany, 31 May, 2017. Ventaleon GmbH, a biotechnology company focusing on the development of inhaled treatments against viral infections, today announced the initiation of a human challenge trial for its flu treatment candidate. The study will assess the safety, tolerability and efficacy of Ventaleon’s lead therapy candidate, an inhaled formulation of LASAG (D,L-lysine acetylsalicylate • glycine), in healthy volunteers infected with the H3N2 subtype of the influenza A virus. Topline results are expected in late 2017. Following a previous Phase II study and based on consultation with the regulatory authorities, this Phase Ib challenge trial was designed to show the causal effect of LASAG inhalation on the influenza virus and is an important step in preparing for pivotal trials. Ventaleon is going to present data from the Phase II study at an upcoming scientific conference.

In the phase Ib study initiated now, approximately 80 volunteers will be randomized in a 2:2:1 ratio into three study arms: 1) 800 mg inhaled LASAG plus oral placebo; 2) inhaled placebo plus oral placebo or 3) inhaled placebo plus oral ASA (acetylsalicylic acid). Treatment will be administered in three daily doses over five days. The primary endpoints include the effect on viral shedding as well as safety. Secondary endpoints include the effect on peak viral titers as well as on alleviating clinical signs and symptoms. Additionally, three exploratory endpoints will be evaluated: serum levels of ASA and SA (salicylic acid), the viral target sequence to assess resistance development and correlations between pharmacokinetics, viral shedding, clinical influenza symptoms and other endpoints. The AKITA® Jet inhalation system (Vectura group plc, United Kingdom) will be used for all inhaled administrations.

In preclinical studies, LASAG showed effectiveness in preventing viral replication by stabilizing nuclear pores through NFkb inhibition, so that the newly generated viral genomes could not leave the nucleus and would not be available for particle assembly. This mode of action without involvement of viral proteins could prevent development of resistance against LASAG-based treatments.

“Influenza is a common, potentially life-threatening infection with lengthy recovery times and a high economic burden. Current treatments are often ineffective as new flu strains frequently develop resistance. Previous studies with inhaled LASAG support that it could be a faster, more effective treatment of influenza, including strains that are resistant to current treatment, addressing a major unmet medical need,” said Dr. Ulrich Dauer, CEO of Ventaleon. “It is Ventaleon’s primary goal to provide highly effective, inhaled therapies against viral infections to address these needs.”

For further information, please contact:

Contact
Ventaleon GmbH
Dr. Ulrich Dauer, CEO
Tel.: +49-6453-58530-40
E-Mail: Diese E-Mail-Adresse ist vor Spambots geschützt! Zur Anzeige muss JavaScript eingeschaltet sein!

Media inquiries
MC Services AG
Katja Arnold, Dr. Brigitte Keller
Tel: +49 89 21022 0
E-Mail: Diese E-Mail-Adresse ist vor Spambots geschützt! Zur Anzeige muss JavaScript eingeschaltet sein!

About Ventaleon GmbH: www.ventaleon.com

Ventaleon GmbH is a biotechnology company focused on the development of inhaled treatments against viral infections. The Company’s lead therapy candidate is an inhaled form of LASAG (D,L-lysine acetylsalicylate • glycine), which it is developing to treat severe influenza. A proof-of-concept study in influenza patients with moderate to severe symptoms demonstrated more rapid symptom decline when administered inhaled LASAG compared to standard of care. The Company is currently preparing to enter a pivotal clinical trial with inhaled LASAG. Ventaleon was founded as a spin-off from Activaero and is supported by a group of leading international investors, including Coöperatief LSP U.A,, BioMedInvest II LP, Abalis Finance AG, Vesalius Biocapital I S.A., Venture Incubator AG, CatheyWorldInvestment Ltd. and BayBg.

Ventaleon Appoints Dr. Ulrich Dauer as Chief Executive Officer

  • Well-known industry executive joins to grow company as it enters late-stage clinical development

Gemuenden, Germany, 24 May, 2017 – Ventaleon GmbH today announced that long-time biotech executive and entrepreneur, Dr. Ulrich Dauer, has joined the company as Chief Executive Officer. He succeeds Dr. Gerhard Scheuch who will continue to serve as a member of the Supervisory Board of Ventaleon.

“We would like to warmly thank Dr. Scheuch for his strong commitment and leadership in advancing Ventaleon’s business and are delighted that he will remain on the Board. His insight and expertise will continue to be highly valuable as the company advances,“ said Dr. Jean Luechinger, Chairman of Ventaleon’s Supervisory Board. He continued: “We are very pleased to have Dr. Dauer lead Ventaleon. He is joining the company at a critical time as it advances into late-stage clinical development. With many years of effectively leading biotechs, forming strong collaborations with the pharmaceutical industry and successfully completing major financial transactions, Dr. Dauer has the ideal skill set to take Ventaleon to the next stage of growth.“

Dr. Dauer has many years of senior executive management experience. He most recently served as Chief Executive Officer of OMEICOS Therapeutics GmbH. Previously he was Chief Strategy Officer at Activaero GmbH, where he led the transaction team responsible for the EUR 130 million sale of Activaero to Vectura plc. In 1997, he founded 4SC AG, serving as CEO for fourteen years, which included taking the company public, building a clinical pipeline and successfully concluding numerous partnerships. Dr. Dauer received his PhD in natural sciences from Julius-Maximilians Universitaet Wuerzburg.

“I am excited to join Ventaleon,“ said Dr. Ulrich Dauer, Chief Executive Officer. “I know Ventaleon’s technology very well from my time at Activaero and believe that the novel inhaled antiviral agents that Ventaleon is developing have the potential to help patients suffering from serious infections such as influenza to get better, faster. I very much look forward to growing the company and advancing it into the next stages of development.“

For further information, please contact:

Contact
Ventaleon  GmbH
Dr. Ulrich Dauer, CEO
Tel: +49-6453-58530-40
 E-Mail: Diese E-Mail-Adresse ist vor Spambots geschützt! Zur Anzeige muss JavaScript eingeschaltet sein!

Media Inquiries 
MC Services AG
Katja Arnold, Dr. Brigitte Keller
Tel: +49 89 21022 0
E-Mail: Diese E-Mail-Adresse ist vor Spambots geschützt! Zur Anzeige muss JavaScript eingeschaltet sein!

About Ventaleon GmbH: www.ventaleon.com

Ventaleon GmbH is a biotechnology company focused on the development of inhaled treatments against viral infections. The Company’s lead therapy candidate is an inhaled form of LASAG (D,L-lysine acetylsalicylate • glycine), which it is developing to treat severe influenza. A proof-of-concept study in influenza patients with moderate to severe symptoms demonstrated more rapid symptom decline when administered inhaled LASAG compared to standard of care. The Company is currently preparing to enter a pivotal clinical trial with inhaled LASAG. Ventaleon was founded as a spin-off from Activaero and is supported by a group of leading international investors, including Coöperatief LSP U.A,. BioMedInvest II LP, Abalis Finance AG, Vesalius Biocapital I S.A., Venture Incubator AG, CatheyWorldInvestment Ltd. and BayBg.