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Dec 21
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Axonics Modulation Technologies Announces $38.5 Million Series B Financing

By Axonics, Press Release
Press Release.

 

Irvine, CA – December 21, 2015 – Axonics Modulation Technologies, Inc., developer of miniaturized implantable Sacral Neuromodulation technology, announced today that it has completed a $38.5 million Series B financing.

Proceeds from the financing will be used to conduct a multi-center clinical study in Overactive Bladder patients anticipated to begin in early 2016 in Europe and North America.

Sacral Neuromodulation therapy is FDA-approved and has been proven to be safe and effective for patients suffering from various chronic conditions, including Overactive Bladder, Fecal Incontinence and Urinary Retention. These conditions affect over 100 million adults in the world.

New investors Advent Life Sciences, based in London and Cormorant Asset Management, based in Boston, joined the existing syndicate led by Edmond de Rothschild Investment Partners of Paris, France. Existing investors NeoMed Management based in Geneva, Beijing-based Legend Capital, a venture capital arm of Legend Holdings, Ltd., Valencia, CA- based The Alfred E. Mann Foundation and a select group of private individuals also participated. Since inception in late 2013, Axonics has raised a total of $59 million in capital.

Raymond W. Cohen, Chief Executive Officer of Axonics said,

“We appreciate that this group of world-class investors recognizes the quality work done by Axonics to create a state-of-the-art rechargeable implantable Sacral Neuromodulation (SNM) System. The Axonics SNM System is 60 percent smaller than the currently marketed SNM technology and also the first rechargeable device available for this market. Moreover, our implanted pulse generator promises to last over 15 years in the body – 3x longer than the other SNM device on the market today. Revenue from the sale of SNM devices is estimated to be approaching $600 million annually with nearly 30,000 devices implanted in patients in 2014 alone. Revenue for this market is projected to grow to over $1 billion by 2019. With only one player in the SNM market today, this represents a significant opportunity for Axonics stakeholders and patients alike.”

Shahzad Malik, M.D. of Advent Life Sciences will join the Axonics Board of Directors serving alongside Chairman, Raphaël Wisniewski of Edmond de Rothschild Investment Partners and other directors including Erik Amble of NeoMed, Darren Cai of Legend, John Petrovich and Barry Keenan of The Alfred E. Mann Foundation and Axonics CEO Raymond W. Cohen.

About Overactive Bladder Syndrome (OAB) and Fecal Incontinence (FI)

OAB is a chronic medical condition that significantly affects patients’ quality of life and often persists for many years. It is estimated that 85 million patients in Europe and the US suffer from OAB and another 40 million suffer from FI. OAB costs an estimated $65 billion every year to the US alone, including direct and indirect costs for physician visits, surgery, nursing home care, incontinence pads, drug therapy, comorbidities and lost productivity. OAB significantly affects quality of life, frequently resulting in depression, social isolation, comorbidities and significant life-style alteration. It is reported that over 3 million people are refractory to drugs and seek third line treatment options. Fecal Incontinence costs an estimated $75 billion every year to the US, including direct and indirect costs. FI is also a primary cause for institutionalization concerning up to 50 percent of nursing home patients. An estimated 2 million patients seek advanced treatment options.

About Sacral Neuromodulation (SNM)

SNM, which is an FDA-approved therapy to treat urinary and fecal dysfunction, is an implantable device-based treatment that delivers adjustable electrical stimulation to a target area of the sacral nerve. After behavioral interventions and medications as first- and second-line treatments, respectively, SNM (also called sacral nerve stimulation) has emerged as a guideline-recommended third-line treatment for OAB. A significant body of evidence demonstrates that patients treated with SNM have therapeutic success and sustained relief of symptoms and improvement in quality of life. The American Urological Association recommends SNM for OAB patients who have not responded to second-line treatment (drugs). SNM is recommended by the American College of Gastroenterology for FI patients who have not responded to conservative treatment. SNM benefits from broad reimbursement coverage in the US and Europe.

About Axonics Modulation Technologies, Inc.

Axonics, based in Irvine, CA, is a privately held venture-backed pre-revenue company that has developed a novel implantable neuromodulation technology. The Company was founded in October 2013 based on a license to numerous fields of use from the Alfred E. Mann Foundation of 19 issued patents directed toward neuromodulation technology.

About Advent Life Sciences

Advent Life Sciences founds and invests in early- and mid-stage life sciences companies that have a first- or best-in-class approach to unmet medical needs. The investing team consists of 16 professionals, each with extensive scientific, medical and operational experience, a long-standing record of entrepreneurial and investment success in the US and Europe, and is particularly focused on supporting entrepreneurs and founders to take innovative new medical entities from concept to approval. The Firm invests in a range of sectors within life sciences, principally drug discovery, enabling technologies and med tech, always with an emphasis on innovative, paradigm-changing approaches. Advent Life Sciences has a presence in the UK, US and France. For more information, please visit www.adventLS.com

About the Alfred Mann Foundation

Founded in 1985 by serial healthcare entrepreneur Alfred E. Mann, AMF is a non-profit medical research organization whose mission it is to bring advanced medical technologies to the public. AMF has developed a myriad of medical devices that have changed the lives of patients across the globe, including cochlear implants that enable deaf people to hear, implantable myoelectric sensors that enable amputees to control robotic prosthetics with their thoughts alone, several diabetes products as well as numerous products in the neural space for management of pain and the recovery of lost muscle function.

About Cormorant Asset Management

Boston-based Cormorant Asset Management is a biotech focused investment firm that was founded in 2013. With over $800 million in assets under management, Cormorant invests in both public and private companies in the biopharmaceutical, medical device and life science research tool fields. Cormorant looks to participate in financings that will enable the company to achieve their first key proof of concept and thereafter allow the company to attract growth capital. In both public and private companies, Cormorant supports innovation that will in the long run add great value to patient lives and healthcare system.

About Edmond de Rothschild Investment Partners

Paris-based Edmond de Rothschild Investment Partners is a leading investor in minority investments into privately owned companies. Affiliate of the Edmond de Rothschild Group, the fund management employs 41 employees and has approximately €1.3 billion under management. Its life sciences team of nine professionals brings together over 60 years of experience in the life science industry and more than 100 years of private equity and venture capital experience. The team has raised more than €450 million through its Biodiscovery franchise and is currently completing the investment of BioDiscovery 4 fund. Since their inception, BioDiscovery Funds have invested in 53 privately held companies, of which 15 have been sold and 14 listed on public financial markets, while 21 are active in the portfolios. BioDiscovery Funds, including BioDiscovery 4, are venture capital funds dedicated to professional investors. These funds are not authorized by the Autorité des Marchés Financiers and may adopt special investment rules. For more information, please visit: www.edrip.fr

About Legend Capital

Legend Capital, based in Beijing, China, focuses on early and expansion-stage venture capital investments with 20 partners managing five USD funds and two RMB funds with over $2 billion focused on innovation and growth enterprises primarily related to China. Legend Capital has invested in nearly 200 companies, of which 23 are already listed on the NYSE, NASDAQ, HKEx, Gretai Securities Market, Shanghai Stock Exchange, GEM and ChiNext of Shenzhen Stock Exchange, with an additional 13 exits through trade-sale. In the Healthcare and Life science sector, Legend Capital has invested in over 20 companies in recent years with outstanding growth trajectory in China and/or a clear China market entry strategy. For more information please visit: www.legendcapital.com.cn

About NeoMed Management

NeoMed Management is an international investment firm registered in Jersey, Channel Islands, with total capital under management in excess of $300 million that focuses exclusively on the healthcare products industry. NeoMed invests in all stages of development from start-up to later stage growth. Since inception in 1997, NeoMed has successfully invested in more than 40 innovative European and North American companies with outstanding growth prospects. For more information please visit: www.neomed.net

Dec 16
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The first electronic cigarette to be approved as a medicinal product

By Press Release
Press Release.

 

MHRA grants marketing authorisation for e-Voke, the first electronic cigarette to be approved as a medicinal product.

 

Advent Life Sciences is pleased to announce that the e-Voke electronic inhaler (e-Voke) is the first ‘electronic cigarette-type’ device to be granted a license as a nicotine replacement therapy by the UK Medicines & Healthcare products Regulatory Agency (MHRA). e-Voke was originally developed by CN Creative Ltd, a former Advent Life Sciences portfolio company acquired by British American Tobacco in 2012.

e-Voke is similar in physical form to available, non approved, electronic cigarettes, but has been designed, developed and tested to meet the strict regulatory requirements of safety and consistency of a medicinal product. For the first time, smokers looking to reduce the harm caused by smoking cigarettes will have a safe and effective nicotine replacement product in the form of an electronic cigarette.

“The harm caused to smokers of conventional cigarettes is primarily from tar, carbon monoxide and carcinogens, yet the addiction is from nicotine – a much less harmful substance”

said Kaasim Mahmood, General Partner at Advent Life Sciences.

“e-Voke will allow smokers to manage their nicotine dependency while largely eliminating the toxic and carcinogenic substances in cigarettes, with the potential for very considerable health benefits. It is for this reason that we supported CN Creative and its founding entrepreneurs in their aim to develop a medically regulated e-cigarette”

he added.

“For the first time adults will have a true safer alternative to smoking, that has been through the rigor of medicinal regulation, a world’s first and a leap forward for the category and the consumer”

said David Newns, former Joint CEO of CN Creative.

About e-Voke:
e-Voke is used to relieve and prevent withdrawal symptoms and reduce the cravings smokers get when they try to stop smoking or when they cut down the number of cigarettes they smoke. e-Voke contains nicotine and belongs to a group of medicines known as nicotine replacement therapy (NRT). When smokers stop smoking or cut down the number of cigarettes they smoke, their body misses the nicotine that they have been getting from cigarettes. They may experience unpleasant feelings and a strong desire or craving to smoke. The nicotine they get from using e-Voke replaces the nicotine and relives the unpleasant withdrawal symptoms. It will also help to stop their craving to smoke.

About Advent Life Sciences:
Advent Life Sciences founds and invests in early- and mid-stage life sciences companies that have a first- or best-in-class approach to unmet medical needs. The investing team consists of 16 professionals, each with extensive scientific, medical and operational experience, a long-standing record of entrepreneurial and investment success in the US and Europe, and is particularly focused on supporting entrepreneurs and founders to take innovative new medical entities from concept to approval. The Firm invests in a range of sectors within life sciences, principally drug discovery, enabling technologies and med tech, always with an emphasis on innovative, paradigm-changing approaches. Advent Life Sciences has a presence in the UK, US and France.

Sep 30
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Advent Life Sciences announces the Appointment of Roy Lobb as Venture Partner

By Advent Life Sciences, Press Release
Press Release.

 

London, UK. September 30 2015

Advent Life Sciences announced today the appointment of Roy Lobb as Venture Partner. Roy brings over 25 years of biotechnology industry experience with an outstanding record as a scientist and company founder. Following a career at Biogen where he led the discovery of a new cell adhesion pathway that became the basis of the development of TysabriTM, Roy co-founded Albor Biologics, Avila Therapeutics and Alvos Therapeutics. Roy received a DPhil from Oxford University, and completed post-doctoral research at Harvard Medical School, where he was a faculty member before joining Biogen. Raj Parekh, General Partner, said

“Roy’s record of innovation and his scientific judgement will be of real value to us as we look to create a new generation of biotech companies – we welcome Roy to the Team.” Roy Lobb commented “The Advent team has consistently focussed on supporting insightful new approaches to medical discovery, and I am excited by the opportunity to work closely with them to found and grow innovative new companies.”

– Ends –

About Advent Life Sciences.
Advent Life Sciences founds and invests in early- and mid-stage life sciences companies that have a first- or best-in-class approach to unmet medical needs. The investing team consists of 16 professionals, each with extensive scientific, medical and operational experience, a long-standing record of entrepreneurial and investment success in the US and Europe, and is particularly focussed on supporting entrepreneurs and founders to take innovative new medical entities from concept to approval. The Firm invests in a range of sectors within life sciences, principally drug discovery, enabling technologies and med tech, always with an emphasis on innovative, paradigm-changing approaches. Advent Life Sciences has a presence in the UK, US and France.
For more information, please visit AdventLS.com

Contact : Advent Life Sciences
Melanie McIntosh
Phone : +44 (0)207 932 2100
email : melanie@adventLS.com

Sep 23
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Advent Life Sciences announces the appointment of Mary Kerr as Operating Partner

By Advent Life Sciences, Press Release
Press Release.

 

London, UK. September 23 2015 

Advent Life Sciences announced today the appointment of Mary Kerr as an Operating Partner. Mary joins from GSK, where she has held a range of senior leadership roles most recently as Senior Vice President and Global franchise Leader for GSK’s Immuno-inflammation and Infectious Diseases portfolio. In conjunction with this appointment, Mary will take the role of CEO of NeRRe Therapeutics, a privately held biotechnology company funded by Advent Life Sciences and Novo A/S.

 

– Ends –

 

About Advent Life Sciences.

Advent Life Sciences founds and invests in early- and mid-stage life sciences companies that have a first- or best-in-class approach to unmet medical needs. The investing team consists of 16 professionals, each with extensive scientific, medical and operational experience, a long-standing record of entrepreneurial and investment success in the US and Europe, and is particularly focussed on supporting entrepreneurs and founders to take innovative new medical entities from concept to approval. The Firm invests in a range of sectors within life sciences, principally drug discovery, enabling technologies and med tech, always with an emphasis on innovative, paradigm-changing approaches. Advent Life Sciences has a presence in the UK, US and France.

For more information, please visit www.AdventLS.com

Contact : Advent Life Sciences
Melanie McIntosh
Phone : +44 (0)207 932 2100
email : melanie@adventLS.com

Sep 22
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Artax Biopharma Funded to Clinically Develop Breakthrough Oral Therapies for Autoimmune Diseases

By Artax Biopharma, Press Release, Private Companies
Press Release.

 

Raises $10M Series B to fund Phase Ib-IIa clinical trials for AX-024, a novel oral treatment; and to further develop its pipeline of preclinical candidates

September 22, 2015 08:05 AM Eastern Daylight Time

CAMBRIDGE, Mass.–(BUSINESS WIRE)–Artax Biopharma, a clinical stage biotechnology company developing first-in-class highly selective oral therapies for the treatment of autoimmune diseases, has secured a $10M Series B round of funding. The financing was led by Henri Termeer, former CEO of Genzyme, and Advent Life Sciences; with participation from A.M. Pappas and existing investors. In conjunction with the financing, Henri Termeer and Raj Parekh, General Partner at Advent Life Sciences, will join Artax’s Board of Directors.

Artax’s lead compound, AX-024, is a highly selective immunomodulator of T-cell Receptor (TCR) signaling in autoimmune T-cells. The new funding will be used to advance AX-024 through Phase Ib and IIa clinical trials for the treatment of autoimmune diseases, and to further develop selective Nck inhibitors in partnership with Dr. Balbino Alarcon. Dr. Alarcon’s lab discovered Nck’s role in T-cell activation at the Spanish National Council (CSIC). Nck is a member of the SH2/SH3 family of cytoplasmic adapter proteins involved in transducing signals from receptor tyrosine kinases to downstream effectors, which play a key role in T-cell activation.

“The selective inhibition of Nck is an area of tremendous therapeutic potential for treating autoimmune diseases and one where Artax leads the world’s research efforts. As our AX-024 program advances in the clinic, we continue developing additional Nck-specific compounds,”

said Damia Tormo, founder and CEO of Artax Biopharma.

“We are thrilled with the confidence the new investors have in Artax and its technology. They will help us realize the full potential of our products and enable us to bring them to patients in need.”

“Artax is pursuing breakthrough science: a targeted immunomodulatory approach for autoimmune diseases that does not compromise the protective function of T-cells to external threats,”

said Henri Termeer.

“Artax has the potential to treat a range of autoimmune conditions in which current therapies are not optimal and may result in serious side effects.”

“Artax’s compounds could have clinical utility in virtually any pathogenic T-cell mediated diseases,”

said Raj Parekh, General Partner at Advent Life Sciences.

“We are excited about the potential of this novel science and its broad clinical applications.”

Clinical Phase 1 Study: Excellent Safety and PK/PD Profile

In Phase I studies, orally dosed AX-024 was well tolerated in healthy volunteers even at very high doses. Experiments carried out ex vivo showed that treatment with AX-024 in humans has a significant immunomodulatory effect on T-cells, with dose-dependent behavior, measured either by inhibition of T-cell proliferation or by Th17, Th2 and Th1 cell cytokine secretion. Artax has validated the target and mechanism of action, and demonstrated preclinical proof of concept of AX-024 in various preclinical autoimmune disease (MS, Psoriasis, IBD, Type I diabetes) and GVHD models.

About Artax Biopharma

Artax Biopharma is a clinical stage biopharmaceutical company developing breakthrough therapies for autoimmune diseases. Its pipeline of drugs is based on novel science that targets the interaction between T-cell receptors (TCR) and Nck, a key protein involved in T-cell activation. Based in Cambridge, Massachusetts, more information on Artax Biopharma can be found at www.artaxbiopharma.com.

About Advent Life Sciences

Advent Life Sciences is one of Europe’s leading venture teams investing in life sciences businesses in the UK, Europe and US. The team consists of professionals with extensive scientific, medical and operational experience, and a long-standing track record of entrepreneurial and investment success across the UK, Europe and the US. The firm invests in a range of sectors within life sciences, principally in new drug discovery, enabling technologies and med tech. Realizations in the last three years include Algeta, Avila, CN Creative, EUSA and Micromet. Current investments include Acutus, Aura Biosciences, Biocartis, Cellnovo, f2G, GMP-Orphan, NeRRe, and Versartis. For more information, please visit www.adventls.com.

Contacts

 

For Artax Biopharma

Matt Burke, +1 603-315-0618

mattdavidburke@gmail.com

Sep 19
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Positive Topline Results Announced from Phase I/II Trial in Sanfilippo B Syndrome Patients Using uniQure’s Novel AAV5-Based Gene Therapy

By Press Release
Press Release.

 

  • Safety, Durable NaGlu Protein Expression and Positive Signs of Efficacy Demonstrated in All Four Patients
  • First Clinical Validation of AAV5 Vector Effectively Delivering Target Gene into the CNS
  • Company Intends to Advance Program into Pivotal Stage
  • Conference Call to Discuss Data Scheduled for 8:30 am EDT Monday, September 21

Amsterdam, the Netherlands, September 19, 2015 —uniQure N.V. (Nasdaq: QURE), a leader in human gene therapy, today announced the topline results of one-year follow-up data from a Phase I/II clinical trial conducted by Institut Pasteur(Biotherapies for Neurodegenerative Diseases Unit, Institut Pasteur/INSERM) in partnership with the French Muscular Dystrophy Association and Vaincre les Maladies Lysosomales (collectively “the consortium”) in four Sanfilippo B syndrome (MPSIIIB) patients treated with a novel gene therapy, AMT-110. In all four patients, researchers verified the restoration of catalytical activity of the NaGlu protein in the cerebrospinal fluid (CSF) from 0% at baseline up to 14-17% of normal at 3 months with persistent effect at 12 months. These results validate the effective transmission of the NAGLU gene with the AAV5 vector. The trial demonstrated that incremental cognitive development was maintained in all four patients, aged 20 to 53 months at study onset. The therapy consists of uniQure’s proprietary AAV5 viral vector and a gene cassette including the N-acetylglucosaminidase, alpha (NAGLU) gene, manufactured with uniQure’s proprietary insect cell based-technology. The results of the trial were presented on September 19th at the European Society of Gene and Cell Therapy (ESGCT) and Finnish Society of Gene Therapy (FSGT) Collaborative Congress held in Helsinki, Finland, by Dr. Marc Tardieu, Professor at the Université and Hôpitaux Universitaires Paris Sud and primary investigatorof the trial with co-investigators Professors Jean-Michel Heard and Michel Zérah.

“We are forging new ground in the treatment of Sanfilippo B with this study. For the first time we have shown persistent restoration of NaGlu protein expression over 12 months can be achieved with gene therapy in the CNS,”

said Professor Tardieu.

“Published case studies of attenuated Sanfilippo B patients support that NaGlu protein activity in the range of 5-10% of normal can be considered clinically meaningful and is associated with longer lifespans and higher quality of life for Sanfilippo B patients. We look forward to further confirming these encouraging trends on cognitive development over the next 6-12 months.”

In the trial, four patients received a one-time administration of AAV5 gene therapy dosed over two hours directly into the brain. All patients were maintained under coverage of a continuous immune suppression regimen. No local inflammation or other safety concerns related to the therapy or the procedure have been identified. In addition to establishing the safety of the procedure and the AAV5 viral vector, the most important result was the presence of catalytically active NaGlu protein in the CSF measured at 1, 3, and 12 months after treatment. The fact that all treated Sanfilippo B subjects continued to gain skills throughout the study is extremely encouraging.

“We are gratified that our pursuit of a gene therapy targeting CNS diseases has found this early and promising success. The data validates AAV5 from our insect cell-based manufacturing platform as a safe and effective vector choice for CNS administration. Based on these results, we are negotiating an agreement with the consortium to take over the sponsorship of the program and we intend to advance the program into the pivotal stage of development. We acknowledge the tremendous support we have received from the consortium that was paramount for generating this early proof in patients,” said Joern Aldag, CEO of uniQure. “Sanfilippo B syndrome represents a high unmet medical need and we are committed to developing a gene therapy that can improve and extend the lives of patients and making it available to them and their families worldwide as soon as possible.”

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About Sanfilippo B

Sanfilippo B is a rare inherited lysosomal storage disease that results in serious brain degeneration in children and is generally fatal. The disease stems from an enzyme deficiency caused by a malfunctioning NAGLU gene. Due to the inability to properly break down long chains of sugar molecules called mucopolysaccharides or glycosaminoglycans (GAGs) that are a normal by-product of cell metabolism, the cells accumulate partially degraded oligosaccharides of heparin sulfate, which are molecules that regulate various developmental processes. The clinical manifestations of the disease are mainly neurological with early symptoms observed during the first 5 years of age, leading to a progressive deterioration of cognitive abilities. Affected children begin developing cognitive symptoms at around 2 years of age, proceeding to a precipitous neurological decline with behavioral, sleep and social difficulties between the ages of 4 and 7. Further profound mental retardation ensues, with death occurring around age 17. No proven disease modifying treatments for Sanfilippo B are currently available.

Conference Call and Webcast
uniQure will discuss the data in a webcast conference call at 8:30 am EDT on Monday, September 21, 2015. The
conference call can be accessed by dialling one of the numbers listed below five minutes prior to the start of the call and providing the confirmation code: 3342119.

Local – London, United Kingdom: +44(0)20 3140 8286
Local – New York, United States of America: +1 212 444 0412
Local – Berlin, Germany: +49(0)30 3001 90539
Local – Amsterdam, Netherlands: +31(0)20 716 8296
Local – Milan, Italy: +3902 3600 9869
Local – Paris, France: +33(0)1 76 77 22 28
Local – Brussels, Belgium: +32(0)2 402 3092
Local – Montreal, Canada: +1514 841 2153

Investors may also listen to the webcast of the conference call live on the “Events” section of uniQure’s website, www.uniQure.com. To ensure a timely connection to the webcast, it is recommended that users register at least 15 minutes prior to the scheduled start time. The webcast replay will be available for at least 72 hours following the call.

About uniQure
uniQure is delivering on the promise of gene therapy – single treatments with potentially curative results. We are leveraging our modular and validated technology platform to rapidly advance a pipeline of proprietary and partnered gene therapies to treat patients with CNS, liver/metabolic and cardiovascular diseases. www.uniQure.com

FORWARD-LOOKING STATEMENTS
This press release contains forward-looking statements. All statements other than statements of historical fact are forwardlooking statements, which are often indicated by terms such as “anticipate,” “believe,” “could,” “estimate,” “expect,” “goal,” “intend,” “look forward to”, “may,” “plan,” “potential,” “predict,” “project,” “should,” “will,” “would” and similar expressions. Forward-looking statements are based on management’s beliefs and assumptions and on information available to management only as of the date of this press release. These forward-looking statements include, but are not limited to, statements regarding the progress or timing of the further development of AMT-110, the potential long-term clinical benefit of AMT-110, the ability to demonstrate the efficacy of AMT-110 in larger, late-stage clinical trials, and our ability ultimately to bring AMT-110 to market. Our actual results could differ materially from those anticipated in these forward-looking statements for many reasons, including, without limitation, risks associated with our clinical development activities,
manufacturing processes and facilities regulatory oversight, product commercialization, intellectual property claims, risks associated with our collaborations and collaboration partners, and the risks, uncertainties and other factors described under the heading “Risk Factors” in uniQure’s Form 20-F filed with the Securities and Exchange Commission dated April 7, 2015. Given these risks, uncertainties and other factors, you should not place undue reliance on these forward-looking statements, and we assume no obligation to update these forward-looking statements, even if new information becomes available in the future. www.uniQure.com

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CONTACT

uniQure:
Aicha Diba
Investor Relations
Direct : +31 20 240 6110
Main: +31 20 240 6000
a.diba@uniQure.com

Media inquiries:
Gretchen Schweitzer
MacDougall Biomedical
Direct: +49 172 861 8540
Main: +49 89 2424 3494 or
+1 781 235 3060
gschweitzer@macbiocom.com

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Jul 10
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Edwards Lifesciences enters into agreement to acquire CardiAQ

By CardiAQ Valve Technologies, Press Release
Press Release.

 

IRVINE, CA, July 10, 2015 – Edwards Lifesciences Corporation (NYSE: EW), the global leader in the science of heart valves and hemodynamic monitoring, today announced that it has agreed to acquire CardiAQ Valve Technologies, Inc., a privately held company and developer of a transcatheter mitral valve replacement system.

“Edwards’ primary strategy is to create valuable therapies that transform patient care. We
believe the acquisition and integration of CardiAQ will advance our development of a
transformational therapy for patients with mitral valve disease who aren’t well-served today,”

said Michael A. Mussallem, Edwards’ chairman and CEO.

“While still early in the development of this therapy, the progress of the team of employees and clinicians working on our FORTIS mitral replacement system has reinforced our confidence in a catheter-based approach. We believe the experiences and technologies of FORTIS and CardiAQ are complementary and that this combination will enable important advancements for patients.”

CardiAQ has received a U.S. Food and Drug Administration (FDA) Investigational Device Exemption (IDE) approval to conduct an early feasibility study of up to 20 patients, and also plans to initiate a CE Mark study in Europe.

“CardiAQ is proud of our pioneering efforts in the early development of this transcatheter mitral valve therapy conceived by cardiac surgeon Arshad Quadri, M.D. We believe our technology, which incorporates multiple delivery approaches with a single valve, shows great promise for patients,”

said Rob Michiels, chief executive officer of CardiAQ.

“We look forward to joining Edwards, whose experience and leadership as a developer of
breakthrough therapies for heart valve disease will advance our work,”

said J. Brent Ratz, cofounder, president and chief operating officer of CardiAQ.

The purchase price is up to $400 million, including $350 million in cash at closing, and the remainder payable upon achievement of a European regulatory milestone. The transaction remains subject to customary closing conditions. Edwards expects that this acquisition will be slightly dilutive to 2015 earnings per share. The company will provide updated financial guidance for 2015 when second quarter earnings are released on July 28.

As an update to the temporary pause in the FORTIS program, working closely with its global clinical investigators, Edwards recently completed its review and has reached agreement on protocol revisions to re-start enrollment.

The CardiAQ and FORTIS valve systems are not approved for sale in any country.

About Edwards Lifesciences
Edwards Lifesciences is the global leader in the science of heart valves and hemodynamic monitoring. Driven by a passion to help patients, the company partners with clinicians to develop innovative technologies in the areas of structural heart disease and critical care monitoring, enabling them to save and enhance lives. Additional company information can be found at www.edwards.com.

About CardiAQ Valve Technologies
Privately held CardiAQ, headquartered in Irvine, Calif., has developed a proprietary transcatheter mitral valve (TMV) implant that can be delivered through multiple delivery systems. Through its unique anchoring mechanism that engages and utilizes the patient’s native mitral valve anatomy, physicians will be able to implant a new mitral valve within a beating heart without circulatory support, thus avoiding open-heart surgery. Orbimed led the series B financing and is CardiAQ’s largest shareholder. Other venture investors include Broadview, Advent and Versant.

This news release includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. These forwardlooking statements include, but are not limited to, statements by Michael Mussallem, Rob Michiels and J. Brent Ratz regarding the timing and status of the transaction, and the timing, impact and success of clinical development of mitral valve replacement technologies. Forward-looking statements are based on estimates and assumptions made by management of the company and are believed to be reasonable, though they are inherently uncertain and difficult to predict. Our forward-looking statements speak only as of the date on which they are made and we do not undertake any obligation to update any forward looking statement to reflect events or circumstances after the date of the statement.

Forward-looking statements involve risks and uncertainties that could cause actual results to differ materially from those expressed or implied by the forward-looking statements based on a number of factors including but not limited to unexpected impediments or delays in closing the transaction, unexpected outcomes after more expanded clinical experience with the devices, unexpected changes or delays related to product supply, potentials for unexpected regulatory or quality developments, competitive dynamics, global economic conditions and customer acceptance.

These factors are detailed in the company’s filings with the Securities and Exchange Commission including its Annual Report on Form 10-K for the year ended December 31, 2014.

Edwards, Edwards Lifesciences, the stylized E logo and Edwards FORTIS are trademarks of Edwards Lifesciences Corporation. All other trademarks are the property of their respective owners.

Media Contact:
Sarah Huoh,
949-250-5070

Investor Contact:
David K. Erickson,
949-250-6826

Jul 09
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Success of Cellnovo’s IPO with €31.6 million raised on Euronext in Paris

By Cellnovo, Press Release
Press Release.

 

  • Offer price set at €10.63 per share
  • Market capitalization of €113.6 million
  • Funds to develop production capabilities and accelerate commercial expansion

Paris, France, July 9, 2015 – Cellnovo Group (« Cellnovo »), a medical technology company that has developed and markets the first connected all-in-one diabetes management system, today announces the success of its Initial Public Offering in compartment C of the Euronext regulated market in Paris (“Euronext Paris”), raising €31.56 million through a capital increase.

The Open Price Offering and the Global Placement price has been set at €10.63 per share. The total number of shares issued will be 2,969,557, resulting in a capital increase of €31.56 million. Based on a total of 10,683,873 shares to be admitted to the market and a price of €10.63 per share, Cellnovo’s market capitalization will be €113.6 million at the end of the operation. Cellnovo has granted Société Générale acting in the name and on behalf of the banking syndicate an overallotment option, exercisable from today until August 7, 2015 included, on a maximum of 80,000 new shares or approximately €0.85 million.

The shares offered within the framework of the Offering will be allocated as follows:

  • Global Placement: 2,806,823 shares allocated to institutional investors (which represents approximately €29.8m and 94.5% of the total number of shares allocated);
  • Open Price Offering: 162,734 shares allocated (which represents approximately €1.7m and 5.5% of the total number of shares allocated);
  • In respect to the Open Price Offering, A1 orders will be 100% satisfied and A2 orders will be 100% satisfied.

The settlement/delivery of issued shares in the Open Price Offering and the Global Placement will take place on July 13, 2015. Shares will begin their conditional trading on Euronext Paris from July 10, 2015 at 9.00 AM CET in the form of undertakings to deliver shares (promesses d’actions) until July 13, 2015, and will be traded under ISIN code FR0012633360 and ticker CLNV from July 14, 2015 onwards.

In a very difficult context on the financial markets, the offering benefited from the demand of few leading, long-only French and international investors.

Eric Beard, Chairman & CEO of Cellnovo states:

“We are delighted to announce the success of Cellnovo’s IPO and to be joining Euronext Paris. We are pleased with the interest shown for the placement, despite difficult market conditions, and we welcome new top-quality investors alongside our historical shareholders and Air Liquide Venture Capital. We thank each of them for putting their trust in our disruptive insulin pump technology. The funds raised in this offering will be mainly allocated to finance the scale-up of our production capabilities and the speed-up of our commercial expansion. We look forward to working with our investors towards bringing forward our new and innovative diabetes management system.”

Reminder of the use of proceeds

  • Scale-up its production capabilities;
  • Pursue its R&D investments;
  • Accelerate its commercial expansion, through proprietary sales force and specialized distributors;
  • Finance the obtainment of market approvals in the United States and in other key geographies; and
  • Finance the operational expenditure and the working capital requirement of the Company.

IPO schedule – Next steps

July 10 2015 – Beginning of conditional trading in the Company’s shares on Euronext Paris (in the form of undertakings to deliver shares (promesses d’actions) until July 13 inclusive, 2015)

July 13 2015 – Settlement and delivery of the Offering

July 14 2015 – Beginning of unconditional trading in the Company’s shares on Euronext Paris on the line “CLNV “

August 7 2015 – Deadline for exercise of the Overallotment Option
– End of stabilization period, if any

Identification codes for Cellnovo shares

  • Name: CELLNOVO GROUP
  • ISIN code: FR0012633360
  • Mnemonic: CLNV
  • Section: Compartment C
  • Business sector :  NAF Code: 4651Z – Wholesale trade (business to business) of computers, IT peripheral equipment and software

ICB classification: 4535 – Medical Equipment

Information available to the Public – Copies of the prospectus in the French language (the “Prospectus”), which received a visa from the AMF on June 26, 2015 under number 15-313, comprising a document de base registered with the AMF on February 27, 2015 under number I.15-008 (the “Document de Base”) and a securities note (the “Securities Note”) including the summary of the Prospectus, may be obtained free of charge at the company’s headquarter, (26-28 rue de Londres 75009 Paris, France) as well as from the company’s (www.cellnovo-corp.com) and the AMF’s (www.amf-france.org) websites.

Risk factors – Cellnovo draws the public’s attention to the business-related risks described in Chapter 4 “Risk Factors” of the Document de Base as updated by Chapter 10 “Additional Information” of the Securities Note and the offer-related risks described in Chapter 2 ”Offer-related Risk Factors” of the Securities Note.

About Cellnovo

An independent medical technology company specialising in diabetes, Cellnovo has developed and markets the first connected all-in-one diabetes management system that helps make life easier for patients. Compact, tubeless, intuitive and entirely connected, Cellnovo’s insulin pump comprises a mobile touchscreen controller with an integrated blood-glucose meter. With Cellnovo’s device, certain aspects of diabetes management still require an action from the patient (blood glucose monitoring and injection of insulin just before meals).This unique device allows optimal management of insulin injections whilst ensuring extensive freedom of movement and peace of mind for patients. Thanks to the automatic transmission of data, it also allows the patient’s condition to be continually monitored by family members and healthcare professionals in real-time.
Cellnovo aims to improve the quality of life of patients with type 1 diabetes and more generally all people living with insulin dependency, by using its technology to minimise the constraints and risks associated with this illness.
The current version of the system has already received CE Marking, is reimbursed in most countries and is already being marketed in France and the United Kingdom. Cellnovo has a clearly-defined expansion strategy that involves accelerating the product’s commercialisation, initially in Europe and then in the United States and Asia, and increasing its production capacity to cope with the expected high level of demand.
The insulin pump market is currently estimated to be worth around 2.2 billion dollars, and has substantial potential given that only 17% of the 3.5 million people with type 1 diabetes (in the US/Canada and main European countries) currently use a pump.
Based in France and the United Kingdom, Cellnovo has a 75-strong workforce.

For further information please visit www.cellnovo.com

Cellnovo
Sophie Baratte
investors@cellnovo.com

NewCap
Relations investisseurs
Antoine Denry
cellnovo@newcap.fr
+ 33 1 44 71 94 95

NewCap
Relations Médias
Nicolas Merigeau
cellnovo@newcap.fr
+33 1 44 71 94 98

The First Connected All-in-one Diabetes Management System
THIS PRESS RELEASE IS NOT FOR DISTRIBUTION DIRECTLY OR INDIRECTLY IN THE UNITED STATES, CANADA,
AUSTRALIA AND JAPAN OR TO U.S. PERSONS
Disclaimer

This press release and the information it contains does not, and will not, constitute a public offering to subscribe for or sell, nor the solicitation of an offer to subscribe for or buy, securities of Cellnovo in any jurisdiction, including the United States, Canada, Australia or Japan. No public offering can be made now or in the future without the prior approval by the French Financial Markets Authority (“AMF”) of a prospectus that consists of the Base Document (document de base), which is the subject of this press release, and a Securities Note (note d’opération) subsequently submitted to the AMF. The publication or distribution of this communication may violate applicable laws and regulations in some jurisdictions. Therefore, persons in such countries and in countries in which this communication is broadest, published or distributed must enquire about any local restrictions and comply with them.

In particular:

Cellnovo securities may not be offered or sold in the United States absent registration or an exemption from registration under the U.S. Securities Act of 1933, as amended. Cellnovo does not intend to register any securities in the United States or to conduct a public offering of securities in the United States.
This communication is an advertisement and does not constitute a prospectus for the purposes of the Prospectus Directive (as defined below). A prospectus prepared pursuant to the Prospectus Directive may be published, which, as and when published, can be obtained in accordance with the Prospectus Directive.
In relation to each Member State of the European Economic Area which has implemented the Prospectus Directive (each, a “Relevant Member State”), no action has been taken or will be taken to offer securities to the public that requires the publication of a prospectus in any Relevant Member State other than France. Cellnovo securities may be offered in a Relevant Member State (other than France) only (i) to any legal entity which is a qualified investor as defined in the Prospectus Directive; (ii) to fewer than 150 natural or legal persons (other than qualified investors as defined in the Prospectus Directive); or (iii) in any other circumstances falling within Article 3(2) of the Prospectus Directive, provided, that no such offer of securities shall require Cellnovo to publish a prospectus pursuant to Article 3 of the Prospectus Directive or supplement a prospectus pursuant to Article 16 of the Prospectus Directive.

For the purposes of this provision, the expressions “public offering” and “offer to the public” in relation to any Cellnovo securities in any Relevant Member State means the communication in any form and by any means of sufficient information on the terms of the offer and the securities to be offered so as to enable an investor to decide to purchase or subscribe the securities, as the same may be varied in that Member State by any measure implementing the Prospectus Directive in that Member State. The expression “Prospectus Directive” means Directive 2003/71/EC (as amended, including by Directive 2010/73/EU), and includes any relevant implementing measure in the Relevant Member State.

This communication is only being distributed to and is only directed at (i) persons who are outside the United Kingdom or (ii) persons in the United Kingdom who have professional experience in matters related to investments and who are investment professionals within the meaning of Article 19(5) of the Financial Services and Markets Act 2000 (Financial Promotion) Order 2005 (the “Order”) or (iii) high net worth companies, and other persons to whom it may lawfully be communicated, falling within Article 49(2)(a) to (d) of the Order (all such persons in (i), (ii) and (iii) above together being referred to as “relevant persons”). Cellnovo securities will only be available to, and any invitation, offer or agreement to subscribe, purchase or otherwise acquire Cellnovo securities will be engaged in only with, relevant persons. Any person who is not a relevant person should not act or rely on this release or any of its contents.

All statements other than statements of historical fact included in this press release about future events and are subject to (i) change without notice and (ii) factors beyond the Cellnovo’s control. These statements may include, without limitation, any statements preceded by, followed by or including words such as “target,” “believe,” “expect,” “aim,” “intend,” “may,” “anticipate,” “estimate,” “plan,” “project,” “will,” “can have,” “likely,” “should,” “would,” “could” and other words and terms of similar meaning or the negative thereof. Forward-looking statements are subject to inherent risks and uncertainties beyond Cellnovo’s control that could cause the Company’s actual results or performance to be materially different from the expected results or performance expressed or implied by such forward-looking statements.

Apr 24
Love0

Biocartis raises eur 100 million in successful initial public offering

By Biocartis, Press Release
Press Release.

 

Mechelen, Belgium, 24 April 2015 – Biocartis Group NV (the “Company” or “Biocartis”), an innovative molecular diagnostics company, today announces the results of its initial public offering, launched on 15 April 2015 (the “Offering”).

The final offer price for the Offering has been set at EUR 11.50, giving the Company an initial market capitalization of EUR 450.2 million, or EUR 465.2 million, assuming the exercise in full of the Over-allotment option. Gross proceeds for the Company from the Offering amounted to EUR 100 million, or EUR 115 million, assuming the exercise in full of the Over-allotment Option.

More than EUR 650 million in demand was generated in the Offering. The order book has been built with strong local support both from institutional and retail investors, as well as a wide interest from a mix of long-term, specialist investors across continental Europe, the UK and the US.

“The closing of this Offering, a week ahead of schedule, at the top of the price range and more than EUR 650 million demand generated, underscores the strong belief in the potential of Biocartis and the appeal of our technology and strategy to institutional and retail investors, both in Belgium and internationally,”

Rudi Pauwels, Chief Executive Officer of Biocartis, commented.

“We are delighted with this enthusiasm, and want to thank all our new investors for their support.”

Hilde Windels, Managing Director and Chief Financial Officer of Biocartis, added:

“This is a great testament to the quality of the science and technology at Biocartis and to the opportunities which precision medicine presents us. This successful fundraising gives us the support we need to deliver on these opportunities by ramping up our R&D and global commercial offerings for our unique Idylla™ system and we look forward to this exciting next stage in the Company’s development.”

Results of the Offering

  • The final offer price for the Offering is set at EUR 11.50 (the “Offer Price”).
  • The Offering ended on 23 April 2015 4:00 pm (CEST).
  • The total number of shares issued in the Offering amounts to 8,695,652 new shares of the Company (the “New Shares”).
  • In addition, an over-allotment option to subscribe to up to 1,304,347 additional new shares at the Offer Price, equivalent to EUR 15.0 million, has been granted to KBC Securities NV/SA, as stabilisation manager, on behalf of KBC Securities NV/SA, Kempen & Co N.V. and Petercam NV/SA, to cover over-allotments or short positions, if any, in connection with the Offering (the “Over-allotment Option”, and the additional new shares issued pursuant to the Over-allotment Option and the New Shares collectively being referred to as the “Offered Shares”). The Over-Allotment Option will be exercisable for a period of 35 days following the Listing Date (as defined below). The Company will announce if and when the Over-allotment Option is exercised.
  • 1,597,579 shares, representing approximately 16.0 % of the Offered Shares in the Offering, have been placed with retail investors in Belgium. The allocation table applicable for shares applied for by retail investors can be found below. The average number of shares that was allocated to other investors (excluding certain existing shareholders of the Company that committed to subscribe for an aggregate amount of EUR 21,512,800) amounts to approximately 14%.
  • The gross proceeds for the Company amount to EUR 100.0 million or EUR 115.0 million assuming the exercise in full of the Over-allotment Option. The implied market capitalization of Biocartis is approximately EUR 450.2 million or approximately EUR 465.2 million assuming the exercise in full of the Over-allotment Option.
  • Trading of Biocartis’ shares on the regulated market of Euronext Brussels under the symbol “BCART” is expected to commence, on an “if-and-when-issued and/or delivered” basis, on 27 April 2015 (the “Listing Date”). Payment and delivery of the shares will occur on 28 April 2015, subject to the successful closing of the Offering.
  • Certain existing shareholders of the Company that committed to subscribe for an aggregate amount of EUR 21,512,800 in the Offering at the Offer Price, subject to the closing of the Offering, will be allocated all of the shares that he or she committed to subscribe for, representing 1,870,673 shares.
  • KBC Securities acted as Sole Global Coordinator in the Offering, KBC Securities, Kempen & Co and Petercam acted as Joint Bookrunners.

The shares applied for by retail investors will be allotted according to the allocation table below.

[table omitted]

For more information, please contact:

Biocartis
Rudi Pauwels, CEO/Hilde Windels, CFO
+32 15 632 600
press@biocartis.com

Consilium Strategic Communications
Amber Bielecka/Jessica Hodgson/Chris Welsh/Laura Thornton
+44 (0) 203 709 5701 (London, UK)
biocartis@consilium-comms.com

About Biocartis

Biocartis is an innovative commercial stage molecular diagnostics (MDx) company providing next generation diagnostic solutions aimed at improving clinical practice for the benefit of patients, clinicians, payers and industry. The Company’s proprietary MDx Idylla™ platform is a fully automated, real-time PCR (Polymerase Chain Reaction) system which offers accurate, highly-reliable molecular information from virtually any biological sample in virtually any setting. Idylla™ addresses the growing demand for personalized medicine by allowing fast and effective treatment selection and treatment progress monitoring.

Biocartis is developing and marketing a rapidly expanding test menu addressing key unmet clinical needs in oncology and infectious diseases. These areas represent respectively the fastest growing and largest segments of the estimated US$5 billion MDx market1 which is expected to grow to approximately US$8 billion in 2018.1

Biocartis employs approximately 200 people and is headquartered in Mechelen, Belgium. Further information can be found at: www.biocartis.com

Important information

The information contained in this announcement is for general information only and does not purport to be full or complete. This announcement does not constitute, or form part of, an offer to sell or issue, or any solicitation of an offer to purchase or subscribe for shares, and any purchase of, subscription for or application for, shares in the Company to be issued in connection with the Offering should only be made on the basis of information contained in the prospectus that was made available by the Company (the “Prospectus”) and any supplements thereto, as the case may be. This announcement is not a Prospectus. Investors should not subscribe for any securities referred to in this document except on the basis of information contained in the Prospectus. The Prospectus contains detailed information about the Company and its management, risks associated with investing in the Company, as well as financial statements and other financial data. This announcement cannot be used as basis for any investment agreement or decision.

http://www.alliedmarketresearch.com/ivd-in-vitro-diagnostics-market

This announcement is not for distribution, directly or indirectly, in or into the United States and does not constitute or form a part of any offer or solicitation to purchase or subscribe for securities in the United States. The securities mentioned herein have not been, and will not be, registered under the US Securities Act of 1933, as amended (the “US Securities Act”) and may not be offered or sold in the United States, except pursuant to an exemption from the registration requirements of the US Securities Act. The Company has not registered, and does not intend to register, any portion of the Offering of the Offered Shares in the United States, and does not intend to conduct a public offering of securities in the United States.

This announcement is only addressed to and directed at persons in member states of the European Economic Area (“EEA”) other than Belgium who are “qualified investors” within the meaning of Article 2(1)(e) of the Prospectus Directive (Directive 2003/71/EC and amendments thereto, including Directive 2010/73/EU, to the extent implemented in the relevant Member State of the European Economic Area) and any implementing measure in each relevant Member State of the EEA (the “Prospectus Directive”) (“Qualified Investors”). In addition, in the United Kingdom, this announcement is being distributed only to, and is directed only at, Qualified Investors (i) who have professional experience in matters relating to investments falling within Article 19(5) of the Financial Services and Markets Act 2000 (Financial Promotion) Order 2005, as amended (the “Order”) and Qualified Investors falling within Article 49(2)(a) to (d) of the Order, and (ii) to whom it may otherwise lawfully be communicated (all such persons together being referred to as “relevant persons”). The Offering will only be available to, and any invitation, offer or agreement to subscribe for, purchase, or otherwise acquire securities will be engaged in only with relevant persons. Any person who is not a relevant person should not act or rely on this announcement or any of its contents.

The contents of this announcement include statements that are, or may be deemed to be, “forward-looking statements”. These forward-looking statements can be identified by the use of forward-looking terminology, including the words “believes”, “estimates,” “anticipates”, “expects”, “intends”, “may”, “will”, “plans”, “continue”, “ongoing”, “potential”, “predict”, “project”, “target”, “seek” or “should”, and include statements the Company makes concerning the intended results of its strategy. By their nature, forward-looking statements involve risks and uncertainties and readers are cautioned that any such forward-looking statements are not guarantees of future performance. The Company’s actual results may differ materially from those predicted by the forward-looking statements. The Company undertakes no obligation to publicly update or revise forward-looking statements, except as may be required by law.

The date of completion of listing on Euronext Brussels may be influenced by things such as market conditions. There is no guarantee that such listing will occur and you should not base your financial decisions on the Company’s intentions in relation to such listing at this stage. Acquiring investments to which this announcement relates may expose an investor to a significant risk of losing the entire amount invested. Persons considering such investments should consult an authorised person specialising in advising on such investments. This announcement does not constitute a recommendation concerning the Offering. The value of the shares can decrease as well as increase. Potential investors should consult a professional advisor as to the suitability of the Offering for the person concerned.

No announcement or information regarding the Offering or the Offered Shares may be disseminated to the public in jurisdictions outside of Belgium where a prior registration or approval is required for such purpose. No steps have been taken, or will be taken, for the Offering of shares of the Company in any jurisdiction outside of Belgium where such steps would be required. The issue, the subscription for or purchase of shares of the Company are subject to special legal or statutory restrictions in certain jurisdictions. The Company is not liable if the aforementioned restrictions are not complied with by any person.

KBC Securities NV, Kempen & Co N.V. and Petercam NV (the “Underwriters”) are acting for the Company and no one else in relation to the Offering, and will not be responsible to anyone other than the Company for providing the protections offered to their respective clients nor for providing advice in relation to the Offering.

The Company assumes responsibility for the information contained in this announcement. None of the Underwriters or any of their respective directors, officers, employees, advisers or agents accepts any responsibility or liability whatsoever for or makes any representation or warranty, express or implied, as to the truth, accuracy or completeness of the information in this announcement (or whether any information has been omitted from the announcement) or any other information relating to the Company its respective subsidiaries or associated companies, whether written, oral or in a visual or electronic form, and howsoever transmitted or made available or for any loss howsoever arising from any use of this announcement or its contents or otherwise arising in connection therewith.

In connection with the Offering, KBC Securities NV will act as stabilisation manager on behalf of the Underwriters (the “Stabilisation Manager”) and may engage in transactions that stabilise, maintain or otherwise affect the price of the shares or any options, warrants or rights with respect to, or other interest in, the shares or other securities of the Company for up to 30 days from the Listing Date (the “Stabilisation Period”). These activities may support the market price of the shares at a level higher than that which might otherwise prevail. Stabilisation will not be executed above the Offer Price. Such transactions may be effected on the regulated market of Euronext Brussels, in the over-the-counter markets or otherwise. The Stabilisation Manager and its agents are not required to engage in any of these activities and, as such, there is no assurance that these activities will be undertaken; if undertaken, the Stabilisation Manager or its agents may discontinue any of these activities at any time and they must terminate at the end of the 30-day period mentioned above. Within five business days of the end of the Stabilisation Period, the following information will be made public in accordance with article 5, §2 of the Belgian Royal Decree of 17 May 2007 on primary markets practices: (i) whether or not stabilisation was undertaken; (ii) the date at which stabilisation started; (iii) the date on which stabilisation last occurred; (iv) the price range within which stabilisation was carried out, for each of the dates on which stabilisation transactions were carried out; and (v) the final size of the Offering, including the result of the stabilisation and the exercise of the Over-allotment Option, if any.

This announcement and the information contained herein are not for publication, distribution or release in, or into, the United States, Australia, Canada, or Japan.
Mar 05
Love0

Aura Biosciences Closes $21M Series B Financing

By Aura Biosciences, Press Release, Publicly Listed
Press Release.

 

Prepares to enter clinical trials for the treatment of rare ocular cancers

CAMBRIDGE, MASSACHUSETTS – March 5, 2015 – Aura Biosciences, a biotech company developing highly tumor-targeted breakthrough therapies for rare cancers, has secured a $21M Series B round of funding.  The financing was led by Advent Life Sciences, with participation from new investors, Chiesi Ventures, Ysios Capital, and Alexandria Venture Investments.  Existing investors, including LI-COR Biosciences and Henri Termeer, former Chief Executive Officer of Genzyme, also participated in the financing.   The financing will be used to advance Aura’s unique and novel therapies into clinical trials for the treatment of rare cancers of the eye, and to further develop for additional cancer indications its first-in-class technology that was discovered and developed in partnership with Dr. John Schiller at the National Cancer Institute (NCI).

“Our investors share our vision and our conviction that our technology will uniquely enable the development of breakthrough therapies for orphan cancers that have no effective treatments,”

said Elisabet de los Pinos, founder and CEO of Aura Biosciences.

“Our lead product is focused on treating ocular cancers that are life-threatening, yet for which patients have no targeted or FDA-approved therapies available.  We are dedicated to bringing to this patient population first-in-class therapies that can both eliminate the tumor and preserve vision.”

Aura Biosciences’ platform is based on viral nanoparticles, a new class of drugs that harness the potential of a unique cell targeting for the treatment of cancer.  The technology was discovered and developed in partnership with Dr. John Schiller’s lab at the National Cancer Institute (NCI). Dr. Schiller is the recipient of the National Medal of Technology and Innovation by President Obama, the nation’s highest honor for technological achievement.

The nanoparticles demonstrate highly selective targeting of solid tumors and metastases while leaving normal epithelium untouched.  Aura’s lead product incorporates a viral nanoparticle conjugated with a potent cell-killing laser-activated molecule (IRDye 700DX, LI-COR Biosciences) that is delivered efficiently and selectively to cancerous cells, thereby reducing or eliminating the risk of non-specific activity and/or undesirable toxicity.  Aura Biosciences and the NCI have generated a considerable body of data in vitro and in vivo that shows highly selective tumor uptake in multiple animal models and provides a strong preclinical validation of the technology platform.

“Aura Biosciences is developing first-in-class drugs for rare ocular cancers that can improve patient outcomes and positively impact patient lives,”

said Dale Pfost, general partner at Advent Life Sciences.

“The data generated from Aura’s platform suggests that there is great potential to treat ocular cancers in a completely novel way with high tumor specificity along with maximal drug and laser penetration that can eliminate tumors with no damage to other ocular structures.”

“There is a tremendous unmet need for therapies that can help those with rare diseases,”

said Henri Termeer, former Chief Executive Officer of Genzyme, a pioneer in drug development for orphan indications.

“With Aura’s technology, once the product is confirmed in the clinic, patients with rare ocular cancers will have for the first time and in the near future a non-invasive targeted therapy available to them.”

In conjunction with the financing, Dale Pfost, General Partner at Advent Life Sciences, Art Pappas, CEO of A.M. Pappas & Associates, and Joël Jean-Mairet, Managing Partner at Ysios Capital will join Aura’s Board of Directors.  Current Board member Alan Walts, former head of Genzyme Ventures, will become Executive Chairman.  In addition, Alison Lawton, former Genzyme executive and former COO of OvaScience, will be appointed as Chief Operating Officer.

About Aura Biosciences
Aura Biosciences is applying nanotechnology to the fight against cancer.  Its novel viral nanoparticle technology, developed in partnership with the National Cancer Institute (NCI), harnesses the potential of viral evolution and tumor targeting for the treatment of cancer.  For more information, visit www.aurabiosciences.com.

About Advent Life Sciences
Advent Life Sciences is one of Europe’s leading venture teams investing in life sciences businesses.  The team consists of professionals with extensive scientific, medical and operational experience, and a long-standing track record of entrepreneurial and investment success across the UK, Europe and the US.  The firm invests in a range of sectors within life sciences, principally in new drug discovery, enabling technologies and med tech.  Realizations in the last three years include Algeta, Avila, CN Creative, EUSA and Micromet.  Current investments include Acutus, Biocartis, Cellnovo, f2G, NeRRe, and Versartis.  For more information, please visit www.adventls.com.

About Chiesi Ventures
Chiesi Ventures is a venture capital firm focused on the area of rare and orphan disorders. Our goal is to complement the strategic interest of the Chiesi Group by investing in early stage development opportunities. Chiesi Ventures also aim to accelerate the expansion of the Chiesi network in the US among universities, venture capital investors, rare disease patient organizations and entrepreneurial companies developing treatments for rare diseases. For more information, please visit www.chiesiventures.com.

About Ysios Capital
Ysios Capital is a leading Spanish venture capital firm that provides private equity financing to early- and mid-stage human healthcare and life science companies with a special focus on pharmaceuticals, diagnostics and medical devices. Founded in 2008, Ysios Capital has € 118 million in assets under management distributed over two funds. The second fund has a target size of € 100 million and will remain open to new investors until September 2015. For further information see www.ysioscapital.com

About Alexandria Venture Investments
Alexandria Venture Investments is the strategic venture capital arm of Alexandria Real Estate Equities, Inc. (NYSE: ARE). Founded in 1994, Alexandria is the largest and leading investment-grade real estate investment trust (REIT) focused principally on owning, operating, and developing high-quality, sustainable real estate for the broad and diverse life science and technology industries. In 1996, Alexandria founded Alexandria Venture Investments to actively invest at the cutting edge of novel, breakthrough discoveries in biopharmaceuticals, diagnostics, research tools, medical devices, digital health, and technology. Alexandria is uniquely positioned to fund life science and advanced technology companies based on its experience and in-depth understanding of these industries, its long-term relationships with leading investors, and its world-class international scientific advisory network. For more information, please visit www.are.com.

About LI-COR Biosciences
LI COR Biosciences is a leading manufacturer of near-infrared and chemiluminescence imaging platforms, analysis software, and IRDye® infrared dye reagents for drug discovery, life science research, and pre-clinical imaging. Founded in 1971, the privately held company is based in Lincoln, Nebraska.

Contact:

Matt Burke
+1 603.315.0618
mburke@aurabiosciences.com