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Apr 24
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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

Mar 04
Love0

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

Feb 24
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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

Jan 21
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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

Jan 08
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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

Jan 05
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Versartis Announces Positive 12 Month Data for VRS-317 from Ongoing Extension Study

By Press Release
Press Release.

 

Successful Dose Response Further Confirms Phase 3 Trial Design
Company to Hold Conference Call at 8:30 a.m. ET on Monday, January 5, 2015

MENLO PARK, Calif., Jan. 5, 2015 /PRNewswire/ — 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 positive data from its Extension Study of VRS-317 for naive to treatment, pre-pubertal children with growth hormone deficiency (GHD). The Extension Study is a long-term safety study initiated in March 2014 as patients completed the Versartis’ Phase 1b/2a clinical trial of VRS-317 in children with GHD.

“Data obtained after 12 months of continuous dosing with VRS-317 are very encouraging as they further demonstrate the safety and efficacy of our long-acting form of recombinant growth hormone,”

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

“In the group of patients in the Extension Study who were moved from a weekly dose of 1.15 mg/kg in the Phase 2a trial to a semi-monthly dose of 3.5 mg/kg in the Extension Study, we saw an increase in IGF-I levels as predicted by our PK/PD model. After 6 months in the Extension Study, the IGF-I levels of the patients who were moved to the 3.5 mg/kg semi-monthly dose were almost a full standard deviation higher than the IGF-I levels of the patients who received the 2.5 mg/kg semi-monthly dose. Furthermore, a subset of this group who were treated for 6 months at the higher dose recorded an average increase in height velocity of nearly two centimeters per year from the first 6 months to the second 6 months. Typically, a decrease in height velocity in the second 6 months of treatment would be expected for daily growth hormone therapy. These results clearly demonstrate a dose response in both IGF-I levels and height velocity providing further confirmation of the VRS-317 semi-monthly dose of 3.5 mg/kg selected for our Phase 3 VELOCITY Study.”

Dr. Cleland continued,

“The Extension Study continued to show that VRS-317 is well tolerated and that the safety profile is comparable to daily growth hormone therapy. There were no unexpected or serious adverse events and the few events noted were mild and transient. The number of adverse events declined in the second 6 months of therapy and there were no new adverse events or increases in adverse events for patients switching doses, giving us further confidence in the safety of using the 3.5 mg/kg semi-monthly dose in the Phase 3 trial. We believe the results to date from the Extension Study further demonstrate our ability to select a dose and regimen with the potential to achieve the desired efficacy in the Phase 3 study. We remain on track to launch our global Phase 3 VELOCITY Study in early 2015.”

The data presented below is included in the most recent corporate presentation, entitled “Versartis Corporate Presentation – January 2015”, and is available online within the “EVENTS AND PRESENTATIONS” section of the Company’s investor relations website at http://ir.versartis.com/events.cfm.

Extension Study Demonstrates Dose Response

The Extension Study was designed to allow all pediatric GHD patients in the previous VRS-317 clinical trials to continue to receive treatment prior to potential marketing authorization. Approximately 95% of patients completing the Phase 2a study elected to continue treatment and enroll in the Extension Study. As part of the Extension Study, the Company increased the dosing for a subset of the patient population such that 20 patients on the 1.15 mg/kg weekly dose in Phase 2a were switched to 3.5 mg/kg semi-monthly, the same dose that will be used in the upcoming global Phase 3 trial. These patients achieved a mean IGF-I SDS of 0.5, which is in the upper part of the therapeutic range and nearly a full standard deviation higher than the mean IGF-I SDS of -0.4 experienced by patients receiving the 2.5 mg/kg semi-monthly dose. This increase in IGF-I was achieved without overexposure to IGF-I.

More importantly, as seen below, a subset of patients in this group who were treated for 6 full months at the higher dose recorded an increase in mean annualized height velocity of nearly two centimeters per year, from 7.5 cm/year in the first 6 months to 9.3 cm/year in the second 6 months. Typically, a decrease in height velocity in the second 6 months of treatment would be expected for daily rhGH therapy. The 3.5 mg/kg semi-monthly dose was selected based upon confirmation of the Company’s PK/PD model from its Phase 1b study.

Lower Waning of Growth Rates Over First 12 Months

As shown below, the mean height velocity measured after 12 months of continuous VRS-317 therapy for the patients who remained on the 5 mg/kg monthly and 2.5 mg/kg semi-monthly doses in the Extension Study was not significantly different from the mean height velocity observed in the same patients at 3, 6, and 9 months. In addition, the mean height velocity for patients completing 12 months of treatment at 2.5 mg/kg semi-monthly was 8.5 cm/year, which is consistent with the first year growth rate for moderate GHD patients receiving the highest approved dose on the labels of Genotropin® or Norditropin®.

The Company believes the lower waning of height velocity over time with VRS-317 compared to that typically observed with daily growth hormone therapy suggests that a more consistent pattern of growth may be occurring in VRS-317 patients compared to patients on daily growth hormone therapy.

Safety Profile of VRS-317 Comparable to Daily rhGH Therapy

The safety profile of VRS-317 in all patients over 12 months of continuous VRS-317 therapy was comparable to daily growth hormone therapy. There were no unexpected or serious adverse events and the few events noted were mild and transient. The number of adverse events declined in the second 6 months of therapy and only a minority of patients reported any adverse events. There were no new adverse events or increases in adverse events for patients switching to the 3.5 mg/kg VRS-317 semi-monthly dose. There were only minimal transient excursions of IGF-I SDS above 2 and no excursions above 3. Throughout the second 6 months in the Extension Study, dose administration was performed at home by the parent or caregiver with nearly complete compliance with the schedule of dosing.

Conference Call and Webcast

Versartis will hold a conference call on Monday, January 5, 2015 at 8:30 a.m. ET (5:30 a.m. PT). The dial-in numbers are (877) 407-0789 for domestic callers and (201) 689-8562 for international callers. A live webcast of the conference call will be available online from the investor relations page of the Company’s corporate website at www.versartis.com.

After the live webcast, a replay will remain available on the Versartis website, www.versartis.com, for 90 days. In addition, a telephonic replay of the call will be available until January 19, 2015. The replay dial-in numbers are (877) 870-5176 for domestic callers and (858) 384-5517 for international callers. Please use the replay conference ID number 13598346.

The VRS-317 VELOCITY Study

The Versartis Long-Acting Growth Hormone in Children compared To Daily rhGH (VELOCITY) Study is a randomized, open-label, Phase 3 registration study 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® (somatropin [rDNA origin] for injection) and Norditropin® (somatropin [rDNA origin] for injection) 34 mcg/kg/day. The primary endpoint is non-inferiority between the two treatment groups for 12 month height velocity. GHD patients enrolling in this study will also be offered the opportunity to enroll in the ongoing pediatric Extension Study after completing the Phase 3 study.

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 a Phase 2a clinical trial evaluating weekly, semi-monthly and monthly dosing regimens of VRS-317 in children with GHD in June 2014 and is initiating a Phase 3 study in the same patient population in early 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 regarding our anticipated 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.

Contacts:

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

SOURCE Versartis, Inc.
News Provided by Acquire Media

Nov 10
Love0

Advent Life Sciences Promotes Kaasim Mahmood to General Partner and Alain Huriez to Partner

By Advent Life Sciences, Press Release
Press Release.

 

London, UK. November 10 2014

Advent Life Sciences today announced the promotion of Kaasim Mahmood, MD to General Partner. Kaasim has been with Advent since 2005 and has been responsible for several investments including uniQure, CN Creative and NeRRe Therapeutics.

Alain Huriez, MD is promoted to Partner. Alain, based in Paris France, joined Advent in 2012 as a Venture Partner.

About Advent Life Sciences.
Advent Life Sciences is one of Europe’s leading venture teams investing in life sciences businesses. The team consists of 11 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. Realisations in the last three years include Algeta, Avila, CN Creative, EUSA, Micromet. Current investments include Acutus, Biocartis, Cellnovo, F2G, NeRRe, Versartis. For more information, please visit www.adventLS.com

Contact : Advent Life Sciences
Raj Parekh, General Partner
Phone : +44(0)207 932 2100
email : Raj.Parekh@adventLS.com

Oct 28
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Advent Life Sciences Raises £145.5M (USD 235M) for its Second Life Sciences Venture Capital Fund

By Advent Life Sciences, Press Release
Press Release.

 

London, UK, October 28 2014. – Advent Life Sciences today announced the closing of Advent Life Sciences Fund II (ALSF II), a £145.5M (USD 235M) venture capital fund raised to seed and build life sciences companies in the UK, Europe and the US. The Fund will back entrepreneurs and early-stage and mid-stage companies with the potential to deliver first- or best-in-class breakthrough products for unmet medical needs. The Fund, which quickly exceeded its target, was raised entirely from independent financial investors including funds-of-funds, pension funds, and family offices.

“We thank our returning and new LPs for the strength of their support, which allowed us to raise the commitments for this Fund in a matter of weeks”

said Raj Parekh, General Partner. He added

“The interest from LPs and demand for the Fund, particularly in current markets, is in large part a recognition of the scientific and medical entrepreneurs, CEOs and Management teams whose commitment, vision and energy is enabling our portfolio companies to bring important medical innovations to patients. It is a privilege to work with them.”

About Advent Life Sciences

Advent Life Sciences is one of Europe’s leading venture teams investing in life sciences businesses. The team consists of 11 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. Realisations in the last three years include Algeta, Avila, CN Creative, EUSA, Micromet. Current investments include Acutus, Biocartis, Cellnovo, f2G, NeRRe, Versartis. For more information, please visit www.adventLS.com

 

Contact
Advent Life Sciences
Raj Parekh, General Partner
Phone : +44(0)207 932 2100
Email : Raj.Parekh@adventLS.com

Sep 04
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Biocartis raises eur 64.5 million (approx. USD 85 million)

By Biocartis, Press Release
Press Release.

 

Investment supports commercial roll-out of Idylla™, Biocartis’ flagship molecular diagnostics system, and the development of the system’s menu of diagnostics tests.

 

Mechelen (Belgium), September 4, 2014 (8.30 CET) – Biocartis announced today it has successfully completed an EUR 64.5 million equity fundraising, one of the largest private rounds in the European life sciences industry in recent years. The additional capital will fund the commercial roll-out of Idylla™ in Europe later this year, and the expansion of its commercial reach beyond Europe as of next year. Furthermore, the fundraising will also support and accelerate the development of a wide range of diagnostic tests for Idylla™. With this round, the total capital invested in Biocartis to date amounts to EUR 240 million (approx. USD 316 million).

The capital round is subscribed by Johnson & Johnson Development Corporation,   Hitachi Chemical Corporation, PMV Tina Fund and a few existing and new family offices.

Hilde Windels, CFO at Biocartis, stated:

“We believe this major fundraising demonstrates the support for Biocartis’ ambition to make personalized medicine a truly sustainable, everyday practice. By intensifying the development of our assay menu, we intend to demonstrate the potential of Idylla™ in the field of oncology, infectious diseases and beyond.  We thank our investors for their ongoing support and their belief in Biocartis’ groundbreaking role in transforming molecular diagnostics.”

About Biocartis (www.biocartis.com)

Biocartis strives to transform the global diagnostics market by providing instant access to personalized medicine for patients worldwide. The company develops fully integrated and broadly applicable molecular diagnostic solutions that can be used in a wide variety of healthcare settings to provide rapid, high-quality care to patients. Biocartis is working with Janssen Pharmaceutica and Abbott Molecular to develop a range of diagnostic tests in different disease areas. Biocartis has set up in-house commercial scale manufacturing capabilities at its premises in Mechelen (near Brussels). The Idylla™ system and its first oncology assay, the IdyllaTM BRAF Mutation Test, have obtained CE-IVD marking.

Baker & McKenzie acted as legal and tax advisor to Biocartis in relation to the new fundraising.