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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

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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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

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.

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.

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

Macrolide Pharmaceuticals, Inc. Raises $22 Million in Series A Financing

By Press Release
Press Release.

 

CAMBRIDGE, Mass. – March 4, 2015 – Macrolide Pharmaceuticals, a new company with groundbreaking technology to develop novel antibiotics, completed a Series A financing of $22 million led by Novartis Venture Fund, Gurnet Point Capital, Roche Ventures, and SROne.  The financing follows a worldwide license agreement between Harvard’s Office of Technology Development and the company, providing exclusive rights to the technology.

Proceeds of the financing will enable Macrolide Pharmaceuticals to expand its proprietary drug discovery platform and accelerate the development of a pipeline of novel antibiotics.

“Andy Myers and I are excited to apply this new technology to a highly effective and safe class of antibiotics, the macrolides, where we already have encouraging data in gram-positive and gram-negative species,”

said Dr. Lawrence Miller, co-founder of Macrolide.

“We believe that we can use this technology platform to develop multiple antibiotic products.  We’re delighted to work with a superb group of sophisticated, highly experienced investors in this endeavor.”

Macrolide Pharmaceuticals focuses on the discovery and development of novel macrolide antibiotics for the treatment of life-threatening bacterial infections caused by drug resistant pathogens.   Macrolide Pharmaceuticals’ strategy is based on unique chemistry developed by Prof. Andrew Myers of Harvard University.  Prof. Myers has developed the first practical total synthesis of the macrolide class of antibiotics from basic building blocks.  The macrolide class is among the most successful antibiotic classes, but it has been limited by semi-synthesis so only a handful of macrolides have been commercialized since erythromycin was discovered in 1948.

Using the new technology, Macrolide Pharmaceuticals can synthesize a huge range of macrolides, and many macrolides have already been synthesized with promising anti-bacterial activity. The company seeks to extend the anti-bacterial spectrum of the macrolide class, both in Gram-negative infections where treatment options are limited and Gram-positive organisms where macrolides have been in widespread use.  The synthetic technology provides a platform for the creation of multiple antibiotic products.

The initial work to develop the Macrolide Pharmaceuticals technology was supported by funding from the Blavatnik Biomedical Accelerator at Harvard University.  Isaac T. Kohlberg, Senior Associate Provost and Chief Technology Development Officer at Harvard explained

“that the ideal development pathway to the clinic for this technology is a well-funded, professionally managed startup company fully committed to its advancement.  We are pleased that this investment group shares our confidence in the potential of Macrolide Pharmaceuticals and the Myers technology.”

The investors in this Series A financing are top-tier investors in the life sciences sector, including SROne (www.srone.com), Roche Ventures (www.roche.com/venturefund),  Gurnet Point Capital (www.gurnetpointcapital.com), and Novartis Venture Fund (http://www.nvfund.com).

The founders of Macrolide Pharmaceuticals are Prof. Myers and Dr. Lawrence Miller.  Prof. Myers and Dr. Miller previously co-founded Tetraphase Pharmaceuticals (NASDAQ:TTPH), an anti-bacterial company with a highly promising tetracycline platform.

About Macrolide Pharmaceuticals

Macrolide Pharmaceuticals focuses on the discovery and development of novel macrolide antibiotics for the treatment of life-threatening bacterial infections caused by drug resistant pathogens.  Using novel technology, Macrolide Pharmaceuticals can synthesize a broad range of macrolides, and initial compounds show promising anti-bacterial activity. The company seeks to extend the anti-bacterial spectrum of the macrolide class, both in Gram-negative infections d and Gram-positive organisms. The synthetic technology provides a platform for the creation of multiple antibiotic products.

Macrolide Pharmaceuticals’ strategy is based on unique chemistry developed by Prof. Andrew Myers of Harvard University.  Prof. Myers has developed the first practical total synthesis of the macrolide class of antibiotics from basic building blocks.  The macrolide class is among the most successful antibiotic classes, but it has been limited by semi-synthesis so only a handful of macrolides have been commercialized since erythromycin was discovered in 1948.

For further information, please contact:

Dr. Lawrence Miller

larry@macrolidepharma.com

www.macrolidepharma.com

 

Media Contact:

Kathryn Morris

The Yates Network

845-635-9828

kathryn@theyatesnetwork.com

The American Hospital Association Exclusively Endorses Vestex® Active Barrier Apparel from Vestagen Technical Textiles, Inc.

By Press Release
Press Release.

 

Chicago, Feb. 24, 2015 – – The American Hospital Association (AHA) today announced it has exclusively endorsed Vestagen Technical Textiles, Inc.’s Vestex® Active Barrier Apparel, a protective fabric that combines fluid repellency and antimicrobial technologies embedded into health care worker scrubs, lab coats and jackets. AHA Solutions, Inc., a subsidiary of the AHA, awards the AHA Endorsement to products and services that help member hospitals and health care organizations achieve operational excellence.

Following a proprietary due diligence process, Vestagen’s Vestex apparel was selected based on evidence-based research documenting the effectiveness and safety of Vestex apparel to protect health care professionals and reduce the risk of transmission of bacteria from clothing that cause health care acquired infections (HAIs).

As more studies document that apparel worn in the clinical setting plays a significant role in HAI transmission, more hospitals are requiring staff to wear apparel with fluid repellency and antimicrobial technology, or “active barrier” technology, in an effort to protect them from body fluids and decrease germ transmission risk.

Designed for wear throughout the entire work shift, Vestex protects health care workers and patients from unexpected exposure to body fluids and infectious microorganisms. In a clinical setting, Vestex apparel is proven to prevent and reduce bacteria on the garment using a dual mechanism of action[1]. The first level of protection comes from the fabric’s fluid barrier, which repels splatters, spills and body fluids. The repellency enables a second level of protection, a permanently fiber-bonded antimicrobial that prevents growth of bacteria on the fabric. The fabric also breathes and wicks moisture to keep wearers cool and comfortable all shift long.

“Vestagen’s AHA Endorsed solutions stand out for their effectiveness and safety performance, potential cost savings and patient preference, as demonstrated by published research results,”

said Anthony Burke, senior vice president of the AHA, and president and CEO of AHA Solutions, Inc.

“We are pleased that the AHA prioritized a thorough evaluation of solutions to combat the growing issue of health care apparel contamination and are honored to be recognized as meeting its criteria for excellence,”

said Uncas Benjamin Favret III, president and CEO of Vestagen Technical Textiles.

“As the first in a new class of technology-based, active barrier protective fabrics, Vestex elevates the standard for health care worker and patient safety and will help health care organizations strengthen their culture of safety and enhance patient care.”

[1] Bearman GM, Rosato A, Elam K, et al. A crossover trial of antimicrobial scrubs to reduce methicillin- resistant Staphylococcus aureus burden on healthcare worker apparel. Infect Control Hosp Epidemiol. 2012;33:268–275.

About the AHAThe American Hospital Association (AHA) is a not-for-profit association of health care provider organizations and individuals that are committed to the improvement of health in their communities. The AHA is the national advocate for its members, who include nearly 5,000 member hospitals, health systems and other health care organizations and 43,000 individual members. Founded in 1898, the AHA provides education for health care leaders and is a source of information on health care issues and trends. Visit www.aha.org to learn more.

About AHA Solutions, Inc.
AHA Solutions, Inc. is a subsidiary of the American Hospital Association dedicated to serving member hospitals by helping them identify the optimal solutions to their most pressing market challenges. Through the AHA Endorsement, along with educational programs featuring peers and industry experts, AHA Solutions supports the decision-making process for hospitals looking for partners to help with clinical integration, information technology, talent management, cultural transformation, financial sustainability, the patient flow and other key challenges.

AHA Solutions is proud to reinvest its profits in the AHA Mission: To advance the health of individuals and communities. For more information, contact AHA Solutions at 800.242.4677 or visit www.aha-solutions.org. Also connect with us via Facebook, LinkedIn, and Twitter.

About Vestagen Technical Textiles

Vestagen Technical Textiles develops and markets advanced performance textile products and technologies. Vestagen has developed Vestex®, which represents a new class of technology-based, active barrier protective fabrics combining antimicrobial, liquid repellent and breathability properties. Vestex uniforms and scrubs are designed to protect healthcare workers and their patients from dangerous contaminants. They are clinically proven to prevent and reduce the acquisition and retention of contaminants on clothing and are comfortable, durable and affordable. For more information, visit www.vestagen.com.

CONTACT INFORMATION

American Hospital Association:
Marie Watteau, Director Media Relations
202.626.2351
mwatteau@aha.org

Vestagen Technical Textiles, Inc.:
JD Spangler, Chief Commercial Officer
407.376.2706
jd.spangler@vestagen.com

Versartis Announces Pricing of Follow – On Offering

By Press Release
Press Release.

 

MENLO PARK, Calif., Jan. 21, 2015 (GLOBE NEWSWIRE) — Versartis, Inc. (Nasdaq:VSAR), an endocrine-focused biopharmaceutical company, today announced the pricing of an underwritten public offering of 4,347,826 shares of its common stock at a price to the public of $17.25 per share. In addition, Versartis has granted the underwriters a 30-day option to purchase up to 652,173 additional shares of common stock. The offering is expected to close on January 27, 2015, subject to customary closing conditions.

Citigroup and Credit Suisse are acting as joint book-running managers and representatives of the underwriters for the offering. Cowen and Company is also acting as a joint book-running manager. Canaccord Genuity and SunTrust Robinson Humphrey are acting as co-managers.

A registration statement related to the offering was declared effective by the U.S. Securities and Exchange Commission on January 21, 2015.The offering is being made only by means of a written prospectus forming part of the effective registration statement. A copy of the final prospectus relating to these securities may be obtained, when available, from Citigroup Global Markets Inc., c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY, 11717, by email at prospectus@citi.com or by phone at (800) 831-9146, from Credit Suisse Securities (USA) LLC, Attention: Prospectus Department, One Madison Avenue, New York, NY 10010, by email at newyork.prospectus@credit-suisse.com or by toll-free call to (800) 221-1037, or from Cowen and Company, LLC, c/o Broadridge Financial Services, 1155 Long Island Avenue, Edgewood, New York 11717, Attn:Prospectus Department, or by calling 631-274-2806, or by faxing 631-254-7140.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

About Versartis, Inc.

Versartis, Inc. is an endocrine-focused biopharmaceutical company initially developing VRS-317, a novel, long acting form of recombinant human growth hormone, for the treatment of growth hormone deficiency (GHD). VRS-317 is intended to reduce the burden of daily injection therapy by requiring significantly fewer injections, potentially improving compliance and therefore treatment outcomes. The Company completed the Phase 2a stage of a Phase 1b/2a trial evaluating weekly, semi-monthly and monthly dosing regimens of VRS-317 in children with GHD in June 2014 and began a global Phase 3 registration study in GHD children in January 2015. Further information on Versartis can be found at www.versartis.com.

CONTACT: Corporate
Joshua Brumm
Chief Financial Officer
(650) 963-8582
IR@versartis.com

Investors
Nick Laudico
The Ruth Group
(646) 536-7030
nlaudico@theruthgroup.com

Media
Debra Bannister
Corporate Communications
(530) 676-7373
media@versartis.com

Versartis Initiates Global Phase 3 Study of VRS-317 in Children With Growth Hormone Deficiency

By Press Release
Press Release.

 

The VELOCITY Study Begins for Long-Acting Recombinant Human Growth Hormone in GHD Pediatric Patients

MENLO PARK, Calif., Jan. 8, 2015 (GLOBE NEWSWIRE) — Versartis, Inc. (Nasdaq:VSAR), an endocrine-focused biopharmaceutical company that is developing a novel, long-acting form of recombinant human growth hormone (rhGH), today announced the initiation of its Phase 3 study of VRS-317 for semi-monthly dosing in children with growth hormone deficiency (GHD). This registration trial follows positive data from the Company’s completed Phase 1b/2a VERTICAL study and the ongoing long-term Extension Study.

“The initiation of our global Phase 3 study in pediatric GHD patients is a significant milestone in our goal of commercializing VRS-317,”

said Jeffrey L. Cleland, PhD, Chief Executive Officer.

“After 12 months of continuous dosing with VRS-317 in our Phase 1b/2a and Extension Study, we are confident in our trial design and look forward to furthering the development of our lead product candidate as a semi-monthly treatment. Our team has extensive knowledge and experience in bringing growth hormone therapies to market and we are diligently working towards commercializing VRS-317 for patients and families who suffer with the burden of daily dosing events.”

The Versartis Long-Acting Growth Hormone in Children compared To Daily rhGH (VELOCITY) Study is a randomized, open-label, Phase 3 registration study being conducted in the United States, Western Europe and Canada. This study is expected to enroll up to 136 naïve to treatment, pre-pubertal children with GHD and will include a 3:1 randomization of 3.5 mg/kg VRS-317 semi-monthly to daily rhGH at the highest approved dose on the labels of Genotropin® and Norditropin® 34 µg/kg/day. The primary endpoint is non-inferiority between the two treatment groups for 12 month height velocity. After completing the Phase 3 study, all patients will be offered the opportunity to continue treatment with VRS-317 in the ongoing pediatric Extension Study. The Company anticipates having six month interim results in mid-2016 and final data in early 2017.

About Versartis

Versartis, Inc. is an endocrine-focused biopharmaceutical company initially developing VRS-317, a novel, long-acting form of recombinant human growth hormone, for the treatment of growth hormone deficiency (GHD). VRS-317 is intended to reduce the burden of daily injection therapy by requiring significantly fewer injections, potentially improving compliance and, therefore, treatment outcomes. The Company completed the Phase 2a stage of a Phase 1b/2a trial evaluating weekly, semi-monthly and monthly dosing regimens of VRS-317 in children with GHD in June 2014 and began a global Phase 3 registration study in GHD children in January 2015. Further information on Versartis can be found at www.versartis.com.

Cautionary Note on Forward-Looking Statements

This press release contains forward-looking statements for purposes of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. We may, in some cases, use terms such as “expects,” “intend,” “potential,” “will” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Forward-looking statements include statements regarding our intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things: plans and timing regarding our Phase 3 VELOCITY Study, the potential efficacy of the selected Phase 3 dose of VRS-317 and potential safety, efficacy and other benefits of and market opportunity for VRS-317. These statements are subject to risks and uncertainties that could cause actual results and events to differ materially from those anticipated, including, but not limited to, risks and uncertainties related to: our success being heavily dependent on VRS-317; VRS-317 being a new chemical entity; the potential for serious adverse side effects, if they are associated with VRS-317; VRS-317 may not have favorable results in later clinical trials or receive regulatory approval; other long-acting rhGH products and product candidates have failed to generate commercial success or obtain regulatory approval; delays in enrollment of patients in our clinical trials could increase our costs and cause delay; VRS-317 may cause serious adverse side effects or have properties that delay or prevent regulatory approval or limit its commercial profile; we may encounter difficulties in manufacturing VRS-317; if approved, risks associated with market acceptance, including pricing and reimbursement; our ability to enforce our intellectual property rights; the importance of our license of intellectual property from Amunix Operating, Inc. and our need for additional funds to support our operations. We discuss many of these risks in greater detail under the heading “Risk Factors” section contained in our Quarterly Report on Form 10-Q for the 3 months ended September 30, 2014, which is on file with the Securities and Exchange Commission (SEC). Forward-looking statements are not guarantees of future performance and our actual results of operations, financial condition and liquidity, and the development of the industry in which we operate may differ materially from the forward-looking statements contained in this press release. Any forward-looking statements that we make in this press release speak only as of the date of this press release. We assume no obligation to update our forward-looking statements whether as a result of new information, future events or otherwise, after the date of this press release.

CONTACT: Corporate

Joshua Brumm

Chief Financial Officer

(650) 963-8582

IR@versartis.com

Investors

Nick Laudico

The Ruth Group

(646) 536-7030

nlaudico@theruthgroup.com

Media

Debra Bannister

Corporate Communications

(530) 676-7373

media@versartis.com