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May 24
Love0

Iterum Therapeutics Announces Pricing of Initial Public Offering

By Iterum, Press Release, Publicly Listed
Press Release.

 

DUBLIN and CHICAGO, May 24, 2018 /PRNewswire/ — Iterum Therapeutics plc
(NASDAQ:ITRM), a clinical-stage pharmaceutical company developing anti-infectives
aimed at combatting the global crisis of multi-drug resistant pathogens, today announced
the pricing of its initial public offering of 6,150,000 ordinary shares at a price to the public
of $13.00 per share, for total gross proceeds of approximately $80 million. All of the
shares are being offered by Iterum Therapeutics. The shares are expected to begin
trading on the Nasdaq Global Market on May 25, 2018 under the symbol “ITRM” and the
offering is expected to close on May 30, 2018, subject to customary closing conditions. In
addition, Iterum Therapeutics has granted the underwriters a 30-day option to purchase up
to an additional 922,500 ordinary shares to cover over-allotments, if any.

Leerink Partners and RBC Capital Markets are acting as joint book-running managers for
the offering. Guggenheim Securities is acting as lead manager for the offering. Needham
& Company is acting as co-manager for the offering.
The offering is being made only by means of a prospectus. A copy of the final prospectus
related to the offering, when available, may be obtained from: Leerink Partners LLC,
Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA 02110, or
by telephone at (800) 808-7525, ext. 6132, or by email at syndicate@leerink.com; or from
RBC Capital Markets, LLC, Attention: Equity Syndicate Department, 200 Vesey Street, 8th
Floor, New York, NY 10281, or by telephone at (877) 822-4089, or by email at
equityprospectus@rbccm.com.

A registration statement relating to these securities has been filed with, and declared
effective by, the SEC. This press release shall not constitute an offer to sell or the
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.

Contact:
Jeff Schaffnit
Chief Commercial Officer
312-778-6076
jschaffnit@iterumtx.com

View original content:http://www.prnewswire.com/news-releases/iterum-therapeuticsannounces-
pricing-of-initial-public-offering-300654808.html

SOURCE Iterum Therapeutics

Dec 21
Love0

Aura Biosciences Completes $30 Million Series C Financing

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

 

December 21, 2017

Lead candidate, light-activated AU-011, currently being investigated in Phase 1b/2 study to treat ocular melanoma, an orphan indication

Funding to support ongoing clinical development, enabling buildout of company infrastructure and GMP manufacturing

CAMBRIDGE, Mass.–(BUSINESS WIRE)–Aura Biosciences, a biotechnology company developing a new class of therapies to target and selectively destroy cancer cells using viral nanoparticle conjugates, announced today that it closed a $30 million Series C financing. New investors Lundbeckfonden Ventures and Arix Bioscience plc led the round, with all current investors also participating. Existing investors include Advent Life Sciences, Chiesi Ventures, Ysios Capital, Alexandria Venture Investments, Columbus Venture Partners, LI-COR Biosciences and several individual investors, including the estate of Henri Termeer.

With interim positive data released at the American Academy of Ophthalmology (AAO) 2017 Annual Meeting in November for its Phase 1b/2 clinical trial for light-activated AU-011, the company plans to use proceeds from this round of financing to expand infrastructure supporting ongoing clinical development. Aura intends to continue enrolling patients who have early-stage ocular melanoma in its Phase 1b/2 study of AU-011, the first targeted therapy ever to be developed for the primary treatment of this rare and life-threatening eye cancer. This novel therapy has the potential to selectively destroy cancer cells in the eye while preserving vision. Aura is also expanding in 2018 its footprint in Cambridge, Mass., with the addition of new employees, space and equipment.

“This year has been one of incredible momentum for Aura, with interim positive data reported from our Phase 1b/2 study of AU-011 and enthusiasm from key opinion leaders in ocular oncology across the country,”

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

“We are pleased to enter 2018 with the renewed support of existing investors and to welcome Lundbeckfonden Ventures and Arix Bioscience to our Series C syndicate. We look forward this year to laying the groundwork for Phase 3 clinical development, furthering our commitment to enabling earlier treatment intervention for patients with ocular melanoma.”

“The Aura team has proven nimble while retaining a strong scientific rigor as it has made the transition to a clinical-stage company,”

said Casper Breum, Senior Partner at Lundbeckfonden Ventures.

“We believe that this timely investment will propel the company’s preparations for late-stage studies of AU-011, with the potential to provide a safe and effective therapy where plaque radiation or enucleation are the only options currently,”

said Mark Chin, Investment Director at Arix Bioscience.

With the close of this financing, Breum and Chin will join Alan Walts, Ph.D., Joël Jean-Mairet, Ph.D., Dale Pfost, Ph.D., Arthur Pappas and Dr. de los Pinos as members of Aura’s Board of Directors.

About ocular melanoma

Ocular melanoma, also known as uveal or choroidal melanoma, is a rare and aggressive eye cancer. Ocular melanoma is the most common primary ocular tumor and develops in the uveal tract of the eye. No targeted therapies are available at present, and current radiotherapy treatments can be associated with severe visual loss and other long-term sequelae such as dry eye, glaucoma, cataracts and radiation retinopathy. The most common current treatment is plaque radiotherapy, which involves surgical placement of a radiation device against the exterior of the eye over the tumor. This technique can control the melanoma but can also lead to radiation-related cataract, retinopathy, optic nerve damage and loss of vision. The alternative is enucleation, or removal of the eye. Ocular melanoma metastasizes to the liver in about 40 percent of cases in the long term (source: OMF), and only 15 percent of patients whose melanoma has metastasized survive beyond five years after diagnosis (source: ACS).

About light-activated AU-011

AU-011 is a first-in-class targeted therapy in development for the primary treatment of ocular melanoma. The therapy consists of patented viral nanoparticle conjugates with IR-700DX dye molecules that are activated with an ophthalmic laser. The viral nanoparticles bind selectively to unique receptors on cancer cells in the eye and are derived from technology originally pioneered by Dr. John Schiller of the Center for Cancer Research at the National Cancer Institute (NCI), recipient of the 2017 Lasker-DeBakey Award. The IR-700DX dye molecules are produced by LI-COR Biosciences and are licensed exclusively to Aura for treating ocular cancers.  Upon activation with an ophthalmic laser, the drug rapidly and specifically disrupts the membranes of tumor cells while sparing key eye structures, which may allow for the potential of preserving patients’ vision and reducing other long-term complications of treatment. This therapy can be delivered using equipment commonly found in the ophthalmologist’s office and does not require a surgical procedure, pointing to a potentially less invasive, more convenient therapy for patients and physicians. AU-011 for ocular melanoma has been granted orphan drug and fast track designations by the U.S. Food and Drug Administration and is currently in clinical development.

About Aura Biosciences

Aura Biosciences is developing a new class of therapies to selectively target and destroy cancer cells. Its lead program, AU-011 in ocular melanoma, is being developed under a CRADA with the National Cancer Institute (NCI), part of the National Institutes of Health. For more information, visit www.aurabiosciences.com.

About Lundbeckfonden

VenturesLundbeckfonden Ventures is a part of the asset management subsidiary of The Lundbeck Foundation, which in addition to substantial financial assets, has controlling ownerships in H. Lundbeck A/S, ALK-Abelló A/S and Falck A/S. Lundbeckfonden Ventures has an evergreen structure and invests around $60 million annually in life science companies. The Lundbeckfonden Ventures team is located in Copenhagen, Denmark, and is active in both Europe and USA.

About Arix Bioscience plc

Arix Bioscience plc is a global healthcare and life science company supporting medical innovation. Headquartered in London and with an office in New York, Arix Bioscience sources, finances and builds world class healthcare and life science businesses addressing medical innovation at all stages of development. Operations are supported by privileged access to breakthrough academic science and strategic relationships with leading research accelerators and global pharmaceutical companies.

Arix Bioscience plc is listed on the Main Market of the London Stock Exchange.

For further information, please visit www.arixbioscience.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.

Media Contact

Lynnea Olivarez, 956-330-1917
Ten Bridge Communications
lynnea@tenbridgecommunications.com

Oct 24
Love0

Acutus Medical® Receives FDA Clearance for Advanced Cardiac Mapping Technology for Complex Arrhythmias

By Acutus Medical, Press Release, Publicly Listed
Press Release.

 

FDA clearance of the AcQMap® High Resolution Imaging and Mapping System and AcQMap® 3D Imaging and Mapping Catheter is a major milestone for Acutus Medical

Clearance allows the AcQMap System to be used with commercially available cardiac ablation platforms

CARLSBAD, CA — October 24, 2017 – Acutus Medical® today announced that the U.S. Food and Drug Administration has cleared the AcQMap® High Resolution Imaging and Mapping System and the AcQMap® 3D Imaging and Mapping Catheter for use in patients for whom electrophysiology procedures have been prescribed. The Company plans to introduce initial commercial systems to U.S. customers in early 2018.

“This clearance will allow electrophysiologists (EP’s) in the United States access to a new technology that uses ultrasound to visualize cardiac anatomy and dipole density to map the pathway of every heartbeat. The System can also be used with existing commercially available cardiac ablation platforms,”

said Steven McQuillan, Senior Vice President, Regulatory and Clinical Affairs, for Acutus Medical.

“The AcQMap System was designed in close collaboration with some of the most respected names in the field to provide practitioners with a suite of tools that enables them to rapidly map and re-map to visualize changes throughout the ablation procedure. We firmly believe that by working together with EP practitioners and scientists, we will continue to uncover breakthrough innovations to improve and advance cardiac care.”

European Experience
The AcQMap System has been used in Europe over the past two years in a number of clinical trials and commercial settings. Clinical safety results from the DDRAMATIC-SVT trial were used to support the company’s 510(k) clearance.

“We are extremely excited to have participated in the early clinical work and are now using the technology as part of a patient-specific strategy to assess and treat complex arrhythmias,”

said Dr. Tom Wong, from the Royal Brompton Hospital in London, England.

“The AcQMap System is able to provide global dipole density mapping of irregular and chaotic activation in the atrial chambers, whereas conventional sequential mapping may struggle to provide us with the information that is required. In the cases we have performed thus far, real-time mapping of complex arrhythmias has allowed us to focus on areas of interest and terminate the arrhythmia using ablation therapy. We can now offer individualized, tailored therapy, and are one step closer to identifying the mechanisms of complex arrhythmias.”

About the AcQMap High Resolution Imaging and Mapping System
The AcQMap High Resolution Imaging and Mapping System detects and displays both standard voltage-based and higher resolution dipole density (charge-source) maps. The AcQMap System uniquely combines ultrasound anatomy construction with an ability to map the electrical-conduction of each heartbeat to identify complex arrhythmias across the entire atrial chamber. Following each ablation treatment, the heart can be re-mapped in seconds to continually visualize any changes from the prior mapping.

“Our company is dedicated to developing advanced intracardiac mapping tools that we hope will enable more precise diagnoses and less invasive and more targeted therapies, particularly in patients suffering from complex arrhythmias. The AcQMap System clearance represents a major step not seen since the inception of 3D mapping systems 20 years ago,”

said Graydon Beatty PhD, Chief Technology Officer, for Acutus Medical.

“Despite decades of procedural and technical advancement in the electrophysiology field, only about 50% of patients with persistent complex atrial arrhythmias treated with ablation therapy can expect to remain arrhythmia free at 12 months. At Acutus, we think better mapping and the ability to re-map during the initial therapeutic procedure has the potential to lead to better outcomes and quality of life.”

About Acutus Medical
Acutus Medical is a global heart rhythm technology company transforming the way electrophysiologists diagnose and treat cardiac arrhythmias. Acutus Medical is a privately held company located in Carlsbad, CA. To learn more, visit http://www.acutusmedical.com.

Forward Looking Statements
This press release contains forward-looking statements that are subject to many risks and uncertainties. Forward-looking statements include statements regarding our intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things, our ongoing and planned product development, and clinical and regulatory milestones. We may use terms such as “believes,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” “approximately” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Although we believe that we have a reasonable basis for each forward-looking statement contained herein, we caution you that forward-looking statements are not guarantees of future performance and that 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. As a result of these factors, we cannot assure you that the forward-looking statements in this press release will prove to be accurate. Acutus Medical expressly disclaims any intent or obligation to update these forward-looking statements, except as required by law.

Media Contact
Amy Covino
201-774-3111
Amy.covino@tmstrat.com

Sep 27
Love0

KaNDy Therapeutics launched to advance a breakthrough treatment in Women’s Health

By F2G, Press Release, Private Companies
Press Release.

 

KaNDy Therapeutics launched to advance a breakthrough treatment in Women’s Health

Press Release:
KaNDy Therapeutics launched to advance a breakthrough treatment in Women’s Health

First-in-class once daily NT-814 spun out of NeRRe Therapeutics into new company

Stevenage, UK, September 27th 2017 – KaNDy Therapeutics has been launched today to maximise the value of NT-814, a potential breakthrough medicine for the treatment of chronic debilitating Women’s Health conditions and is backed by internationally recognised life sciences investors: Advent Life Sciences, Fountain Healthcare Partners, Forbion Capital Partners and OrbiMed Advisors.

NT-814 is a first-in-class, once daily, dual mechanism neurokinin-1,3 receptor antagonist. The medicine is being developed as a non-hormonal alternative to hormone replacement therapy for the treatment of postmenopausal vasomotor symptoms (PMVMS). NT-814 has been spun out of NeRRe Therapeutics Holdings Ltd into KaNDy Therapeutics Ltd a separate legal entity.

KaNDy Therapeutics will advance the development of NT-814 into Phase 2b in the lead indication PMVMS while also exploring its potential in other Women’s Health conditions. All formulation, pre-clinical and clinical safety and efficacy data, and intellectual property associated with NT-814 have been transferred to the new company. KaNDy Therapeutics is led by Managing Director Mary Kerr and chaired by Iain Dukes, Venture Partner at OrbiMed Advisors. The company is based at the Stevenage Bioscience Catalyst in the UK.

NT-814 has significant potential to treat multiple debilitating Women’s Health conditions by virtue of the ability to beneficially modulate dysfunctional temperature control and reproductive hormone pathways. NT-814 has already successfully completed a Phase 2a proof of concept study demonstrating its potential to reduce the frequency and severity of PMVMS, and is now being prepared to enter an international Phase 2b study in this anchor indication.

Iain Dukes, Chairman of KaNDy Therapeutics, said, “The formation of KaNDy Therapeutics enables us to maximise the potential of NT-814 in a range of debilitating Women’s Health conditions. We believe NT-814 is one of the few true innovations in Women’s Health in more than two decades and potentially represents a major breakthrough in areas of significant unmet medical need such as PMVMS. Mary has built up an excellent team who have made substantial progress with NT-814 and we’re looking forward to advancing this exciting new product into a Phase 2b programme.”

Professor Richard Anderson, Clinical Adviser, University of Edinburgh, commented, “For many women, menopausal symptoms such as hot flashes are debilitating and long-lasting, and can have a major impact on quality of life. As a potential once daily alternative to HRT without the issues surrounding hormone replacement, NT-814 could bring them considerable relief.”

–ENDS–

 

For further information, please contact:

Mary Kerr, Managing Director of KaNDy Therapeutics

Tel:  +44 1438 906960
Email: info@kandytherapeutics.com

Notes for editors

About KaNDy Therapeutics
KaNDy Therapeutics is a UK based clinical-stage company focused on optimizing the potential of its unique NK-1,3 receptor antagonist NT-814 in the treatment of common, chronic debilitating female sex-hormone related conditions. NT-814 is in development initially as a non-hormonal therapy to treat moderate to severe post-menopausal vasomotor symptoms (PMVMS)).

PMVMS affect up to 75% of peri-menopausal women. Symptoms last for 1–2 years after menopause in most women, but may continue for up to 10 years or longer in others. Approximately 20% of women will have debilitating symptoms. Hot flashes are the primary reason women seek medical care at menopause. Hot flashes not only disturb women at work and interrupt daily activities, but also have a detrimental effect on sleep. Post-menopausal vasomotor symptoms are experienced by millions of women globally on a daily basis.

The company is led by an experienced management team including Dr Mary Kerr (Managing Director), formerly SVP and Global Franchise lead at GSK and Dr Mike Trower (CSO/COO), formerly VP & Head of the External Drug Discovery Group in the Neurosciences CEDD at GSK and Dr Steve Pawsey (CMO) formerly at Circassia and Vernalis.

KaNDy Therapeutics was spun out of NeRRe Therapeutics in September 2017, and is backed by internationally recognised life sciences investors: Advent Life Sciences, Fountain Healthcare Partners, Forbion Capital Partners and OrbiMed Advisors. KaNDy Therapeutics is based at Stevenage Bioscience Catalyst. You can find more information about KaNDy Therapeutics at www.kandytherapeutics.com.

Sep 27
Love0

NeRRe Therapeutics appoints Andrew Kay as Chairman of the Board

By NeRRe Therapeutics, Press Release, Private Companies
Press Release.

 

Extensive development & commercial expertise to guide company growth

Stevenage, UK, 27th September 2017 – NeRRe Therapeutics, which is developing a unique portfolio of neurokinin (NK)-1 receptor antagonists for the treatment of common debilitating conditions caused by neuronal hypersensitivity, has appointed Andrew Kay as Chairman of the Board. Mr. Kay, who has extensive product development and commercial experience across the pharma and biotechnology sectors, takes over from Dr Kaasim Mahmood of Advent, who remains on the Board. Following the demerger of KaNDy Therapeutics, announced today, NeRRe Therapeutics is primarily focused on its lead product orvepitant, which is in a multinational Phase IIb trial for chronic refractory cough.

Mr Kay has worked in the biotechnology sector as CEO of Algeta ASA, which was sold to Bayer for $2.9bn in 2014, and as Chief Commercial Officer and a Board Director of Renovo. He started his industry career in the pharmaceutical sector, working in international roles at Novartis, AstraZeneca and Eli Lilly, following a BPharm Hons degree from Nottingham University School of Pharmacy. Other current roles include Chairman of Blueberry Therapeutics, Chairman of Wilson Therapeutics and Senior Advisor to HealthCap VC. Mr Kay has also been appointed an adviser to KaNDy Therapeutics.

Dr Mary Kerr, CEO of NeRRe Therapeutics, said,

“With his broad experience, Andrew’s appointment as Chairman will bring tremendous value to the company as we advance orvepitant towards late-stage clinical development and commercialisation. NeRRe Therapeutics would also like to thank Kaasim for his guidance and we are pleased that he remains on the Board as Advent’s representative.”

Andrew Kay, Chairman of NeRRe Therapeutics, said,

“With its focus on conditions caused by neuronal hypersensitivity related to neurokinin-1 receptor system dysfunction, the company has the opportunity to make a real difference in areas of unmet medical need such as chronic refractory cough. These are debilitating conditions for thousands of patients worldwide, and I am looking forward to helping NeRRe Therapeutics develop further.”

–ENDS–

A photograph of Andrew Kay is available on request

Notes to Editors

About NeRRe Therapeutics (www.nerretherapeutics.com)

NeRRe Therapeutics is a private UK based clinical-stage company developing a unique pipeline of three neurokinin (NK)-1 antagonists for the treatment of common, chronic and debilitating conditions caused by neuronal hypersensitivity associated with neurokinin-1 receptor system dysfunction. Its portfolio is tackling a range of disorders with high unmet need including chronic refractory cough and chronic pruritus. The company is led by an experienced management team including Dr Mary Kerr (CEO), formerly SVP and Global Franchise lead at GSK and Dr Mike Trower (Co-founder, CSO/COO), formerly VP & Head of the External Drug Discovery Group in the Neurosciences CEDD at GSK.

NeRRe Therapeutics was founded in 2012 as a spin out from GSK.  Since it was founded, it has raised £31.5 million and is backed by leading international life sciences investors: Advent Life Sciences, Fountain Healthcare Partners, Forbion Capital Partners, OrbiMed, Novo A/S, and by GSK. KaNDy Therapeutics was spun out of NeRRe Therapeutics in September 2017. NeRRe Therapeutics is based at Stevenage Bioscience Catalyst.  You can find more information about NeRRe Therapeutics at www.nerretherapeutics.com.

For more information, please contact:

Mary Kerr, CEO of NeRRe Therapeutics
Tel:  +44 1438 906960
Email: info@nerretherapeutics.com 

Sep 27
Love0

KaNDy Therapeutics launched to advance a breakthrough treatment in Women’s Health

By KaNDy Therapeutics, Press Release
Press Release.

 

First-in-class once daily NT-814 spun out of NeRRe Therapeutics into new company

Stevenage, UK, September 27th 2017 – KaNDy Therapeutics has been launched today to maximise the value of NT-814, a potential breakthrough medicine for the treatment of chronic debilitating Women’s Health conditions and is backed by internationally recognised life sciences investors: Advent Life Sciences, Fountain Healthcare Partners, Forbion Capital Partners and OrbiMed Advisors.

NT-814 is a first-in-class, once daily, dual mechanism neurokinin-1,3 receptor antagonist. The medicine is being developed as a non-hormonal alternative to hormone replacement therapy for the treatment of postmenopausal vasomotor symptoms (PMVMS). NT-814 has been spun out of NeRRe Therapeutics Holdings Ltd into KaNDy Therapeutics Ltd a separate legal entity.

KaNDy Therapeutics will advance the development of NT-814 into Phase 2b in the lead indication PMVMS while also exploring its potential in other Women’s Health conditions. All formulation, pre-clinical and clinical safety and efficacy data, and intellectual property associated with NT-814 have been transferred to the new company. KaNDy Therapeutics is led by Managing Director Mary Kerr and chaired by Iain Dukes, Venture Partner at OrbiMed Advisors. The company is based at the Stevenage Bioscience Catalyst in the UK.

NT-814 has significant potential to treat multiple debilitating Women’s Health conditions by virtue of the ability to beneficially modulate dysfunctional temperature control and reproductive hormone pathways. NT-814 has already successfully completed a Phase 2a proof of concept study demonstrating its potential to reduce the frequency and severity of PMVMS, and is now being prepared to enter an international Phase 2b study in this anchor indication.

Iain Dukes, Chairman of KaNDy Therapeutics, said,

“The formation of KaNDy Therapeutics enables us to maximise the potential of NT-814 in a range of debilitating Women’s Health conditions. We believe NT-814 is one of the few true innovations in Women’s Health in more than two decades and potentially represents a major breakthrough in areas of significant unmet medical need such as PMVMS. Mary has built up an excellent team who have made substantial progress with NT-814 and we’re looking forward to advancing this exciting new product into a Phase 2b programme.”

Professor Richard Anderson, Clinical Adviser, University of Edinburgh, commented,

“For many women, menopausal symptoms such as hot flashes are debilitating and long-lasting, and can have a major impact on quality of life. As a potential once daily alternative to HRT without the issues surrounding hormone replacement, NT-814 could bring them considerable relief.”

–ENDS–

 

For further information, please contact:

Mary Kerr, Managing Director of KaNDy Therapeutics

Tel:  +44 1438 906960
Email: info@kandytherapeutics.com

Notes for editors

About KaNDy Therapeutics
KaNDy Therapeutics is a UK based clinical-stage company focused on optimizing the potential of its unique NK-1,3 receptor antagonist NT-814 in the treatment of common, chronic debilitating female sex-hormone related conditions. NT-814 is in development initially as a non-hormonal therapy to treat moderate to severe post-menopausal vasomotor symptoms (PMVMS)).

PMVMS affect up to 75% of peri-menopausal women. Symptoms last for 1–2 years after menopause in most women, but may continue for up to 10 years or longer in others. Approximately 20% of women will have debilitating symptoms. Hot flashes are the primary reason women seek medical care at menopause. Hot flashes not only disturb women at work and interrupt daily activities, but also have a detrimental effect on sleep. Post-menopausal vasomotor symptoms are experienced by millions of women globally on a daily basis.

The company is led by an experienced management team including Dr Mary Kerr (Managing Director), formerly SVP and Global Franchise lead at GSK and Dr Mike Trower (CSO/COO), formerly VP & Head of the External Drug Discovery Group in the Neurosciences CEDD at GSK and Dr Steve Pawsey (CMO) formerly at Circassia and Vernalis.

KaNDy Therapeutics was spun out of NeRRe Therapeutics in September 2017, and is backed by internationally recognised life sciences investors: Advent Life Sciences, Fountain Healthcare Partners, Forbion Capital Partners and OrbiMed Advisors. KaNDy Therapeutics is based at Stevenage Bioscience Catalyst. You can find more information about KaNDy Therapeutics at www.kandytherapeutics.com.

May 19
Love0

Iterum Secures $65 Million in Series B Financing

By Iterum, Press Release, Publicly Listed
Press Release.

 

Funding to support the Phase 3 clinical development of oral penem antibiotic

DUBLIN, IRELAND, and CHICAGO –May 19, 2017 – Iterum Therapeutics Limited, an Irish clinical-stage pharmaceutical company focused on the development and commercialization of anti-infectives for patients with infectious diseases and other acute illnesses, today announced that it has closed an oversubscribed Series B investment round raising $65 million. The financing was led by new investor Arix Bioscience plc, and included Pivotal bioVenture Partners, Advent Life Sciences, Domain Associates and Bay City Capital. All of Iterum’s current investors (Frazier Healthcare Partners, Canaan Partners, Sofinnova Ventures and New Leaf Venture Partners) also participated in the round.

Iterum is developing sulopenem, a novel oral and intravenous antibiotic, for the treatment of Gram-negative multi-drug resistant infections. The proceeds of this financing will be used for production of clinical supplies and registration batches, expanding the chemistry, manufacturing and control and development organizations and execution of the uncomplicated urinary tract infections Phase 3 pivotal program. The estimated timeline for filing an New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) is year-end 2019, with Phase 3 pivotal trials expected to begin in the first half of 2018.

Sulopenem has demonstrated broad-spectrum in vitro activity against extended spectrum β-lactamase producing and quinolone-resistant Gram-negative pathogens that are increasingly prevalent in both the inpatient and outpatient settings. These resistant pathogens are common causative agents of the initial target indications for sulopenem, including uncomplicated urinary tract infections, complicated urinary tract infections and complicated intra-abdominal infections (uUTI, cUTI and cIAI).

“The closing of this round, which was highly competitive and substantially oversubscribed, is an important milestone for Iterum,”

said Corey Fishman, CEO of Iterum.

“This success reflects the significant achievements we have made to date in the development of sulopenem. We are excited to welcome such high quality Series B investors into the existing blue-chip syndicate. With more than 25 million infections annually in the U.S. in our initial indications, and effective treatment options becoming more and more limited due to increasing resistance, we believe that sulopenem has the potential to play an important role in treating these infections.”

As part of the financing, Mark Chin of Arix Bioscience, Tracy Saxton of Pivotal bioVenture Partners and Shahzad Malik of Advent Life Sciences will join Iterum’s Board of Directors.

“Arix is delighted to lead Iterum’s financing of its novel, oral penem that has the potential to significantly improve the treatment paradigm for patients with multidrug resistant Gram-negative infections,”

said Chin, investment manager at Arix Bioscience.

“Since Iterum was founded in late 2015, it has made tremendous progress in the development of sulopenem, and we are excited to provide capital to fund the Phase 3 development of this novel product.”

About Iterum Therapeutics Limited
Iterum Therapeutics Limited is an Irish clinical-stage pharmaceutical company dedicated to developing differentiated anti-infectives aimed at combatting the global crisis of multi-drug resistant pathogens to significantly improve the lives of people affected by serious and life-threatening diseases around the world. Iterum is advancing its first compound, sulopenem, a novel penem anti-infective compound with oral and IV formulations in an IV only class of antibiotics that has demonstrated potent in vitro activity against a wide variety of gram-negative, gram-positive and anaerobic bacteria resistant to other antibiotics. Iterum has received QIDP designations for its oral and IV formulations for the treatment of uUTI, cUTI and cIAI. Iterum is led by a highly experienced team and backed by a blue-chip venture capital syndicate.For more information, please visit http://www.iterumtx.com.

About Arix Bioscience plc
Arix Bioscience plc is a global healthcare and life science company supporting medical innovation. Headquartered in London and with an office in New York, Arix Bioscience sources, finances and builds world class healthcare and life science businesses addressing medical innovation at all stages of development. Operations are supported by privileged access to breakthrough academic science and strategic relationships with leading research accelerators and global pharmaceutical companies.

Arix Bioscience plc is listed on the Main Market of the London Stock Exchange.

For further information, please visit http://www.arixbioscience.com.

About Pivotal bioVenture Partners
Pivotal bioVenture Partners is a newly launched, San Francisco-based venture capital firm. Pivotal’s investment strategy is centered on identifying companies developing differentiated science from discovery to early clinical development with the potential to deliver transformative therapies.
For more information, please visit http://www.pivotalbiovp.com.

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

About Domain Associates
Founded in 1985, Domain was one of the first venture capital firms to exclusively invest in the life sciences sector. Today, with more than $2.7 billion in capital raised, Domain has been a trusted partner in life sciences investing helping more than 260 companies develop novel medical products to advance human health. http://www.domainvc.com.

About Bay City Capital
Founded in 1997, Bay City Capital LLC is a life sciences venture capital firm with a global diversified strategy ranging from seed stage to public companies, and including innovation, restructuring opportunities, and growth investing. For more information, please visit http://www.baycitycapital.com.

Media Contact:

Theresa Maloney
Cogenta Communications
415-225-5261
theresa@cogentacom.com

May 02
Love0

Axonics Announces $14.5 Million First Close of Series C Financing

By Axonics, Press Release
Press Release.

 

Irvine, CA – May 2, 2017 – Axonics Modulation Technologies, Inc., developer of the first rechargeable Sacral Neuromodulation (r-SNM™) system for the treatment of urinary and fecal dysfunction, announced today that it has completed a $14.5 million first closing of its Series C financing.

Axonics intends to raise $30 million in its Series C financing. Proceeds from the financing will be used to conduct a pivotal clinical study in Overactive Bladder patients to gain U.S. FDA approval and prepare the Company to access markets around the world. The U.S. pivotal study is anticipated to begin in the second half of 2017 in select medical centers in North America and Europe.

The Series C financing first closing was comprised of all of Axonics’ major stockholders including Edmond de Rothschild Investment Partners based in Paris, London-based Advent Life Sciences, Boston-based Cormorant Asset Management, Beijing-based Legend Capital, Geneva-based NeoMed Management, and a select group of private individuals.

“These world-class investors have provided Axonics with phenomenal support throughout the development phase of our project, including attainment of key milestones such as European and Canadian regulatory approval and completion of our 50-patient European clinical study,”

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

“Revenue from the sale of SNM devices is estimated at nearly $700 million in 2016 and is projected to grow to over $1 billion by 2021. With only one player in the SNM market today, our miniaturized rechargeable system represents a very attractive opportunity in the medtech space.”

About Axonics Modulation Technologies, Inc.

Axonics, based in Irvine, CA, is a privately-held venture backed company that has developed a novel implantable neuromodulation technology for patients with urinary and fecal dysfunction and can be further directed towards several clinical indications. The Axonics r-SNM System includes a miniaturized rechargeable stimulator qualified to function at least 15 years, a charging system optimized for reduced charge time and minimal heating, a patient-friendly remote control and an intuitive clinician programmer that facilitates the lead placement procedure and programming. For more information, visit the Company’s website at www.axonicsmodulation.com

Mar 15
Love0

Moximed Closes Oversubscribed $50MM Financing Round

By Moximed, Press Release, Private Companies
Press Release.

 

Hayward, CA, USA, March 15, 2017 – Moximed®, Inc., developer of unicompartmental load absorber implants for active patients with painful knee osteoarthritis (OA), announced today an oversubscribed Series C round of $50MM with new investors Advent Life Sciences and Future Fund joining existing investors NEA, Morgenthaler Ventures, Gilde Healthcare, GBS Venture Partners, and Vertex Healthcare.  As part of the financing, Shahzad Malik, M.D., General Partner at Advent Life Sciences, and Brigitte Smith, Managing Director at GBS Venture Partners, will join the Board of Directors.

Moximed created the category of shock absorbing implants for knee OA, with treatment durability now established to nearly nine years on the initial patients. The Moximed implants do not require bone cutting or bone removal, and, importantly, they absorb excess joint load rather than shift load to other areas of the joint.  Moximed has fully enrolled its FDA pivotal clinical study of the KineSpring® System and is currently enrolling an FDA IDE clinical study of the Atlas® System.

“This financing round is timely, as we are completing the primary endpoint follow-up for our FDA pivotal study this month,”

said CEO Kevin Sidow.

“We expect this investment to fully fund the company through FDA approval and early US commercialization of our products.  There is a massive demand for new treatment options by patients who want to maintain an active lifestyle until they are ready for a knee replacement.  The tremendous patient interest and surgeon enthusiasm we are witnessing in our current Atlas IDE study is validating our effort to address this clinical need.”

“Patients between the ages of 35 and 65 years old represent the fastest growing segment of the knee OA population,” added Shahzad Malik, of Advent Life Sciences. “These patients are often considered too young for traditional joint replacement and are desperate for a treatment alternative.  We are excited to support Moximed’s effort to address this opportunity.”

Feb 27
Love0

Arrakis Therapeutics Announces $38M Series A Financing To Target RNA with Small-Molecule Medicines And Names Michael Gilman Chairman and CEO

By Arrakis Therapeutics, Press Release, Private Companies
Press Release.

 

Veteran management team to re-architect small molecule drug discovery to pursue new RNA targets within vast human transcriptome

Waltham, Mass., February 27, 2017 – Arrakis Therapeutics, a pioneering biopharmaceutical company, has completed a $38 million Series A financing led by Canaan Partners with participation by Advent Life Sciences, Pfizer Inc., Celgene Corporation, Osage University Partners, and biotech industry leader Henri Termeer.  The company has also named serial entrepreneur and biotech leader Michael Gilman, Ph.D., as Chairman and Chief Executive Officer of Arrakis.

The proceeds from the Series A financing will be used to advance Arrakis’ proprietary discovery platforms, comprised of a high-throughput, comprehensive system of bioinformatics tools, assays and chemical libraries that can identify new ribonucleic acid (RNA) targets and create new small-molecule drugs. Using its TRYST™ and PEARL-seq™ platforms, Arrakis is developing an internal product pipeline of RNA-targeted small molecules focused on neurology, oncology, and rare genetic disorders. The basis of Arrakis’ unique approach is a proprietary chemical biology technology that interrogates structures of folded RNAs in their native state, within cells, to enable discovery and rational design of potent, selective small-molecule inhibitors of RNA function.

“RNA is the locus of most human biology, yet our current pharmacopeia is largely limited to protein targets,”

said Dr. Gilman.

“Arrakis intends to re-architect small molecule drug discovery by redirecting, modifying, and creating tools that enable medicinal chemistry to directly address therapeutically-important RNA molecules. Our substantial intellectual property, financial resources, and the extensive experience of our team in discovering and developing novel drugs will enable us to build a pipeline of new small-molecule therapeutics for patients not helped by today’s medicines.”

Targeting RNA with Small Molecules

The transcriptome encompasses all of the RNA transcribed from our genetic blueprint, including coding RNAs, which are translated into proteins, and noncoding RNAs, which regulate the fate and function of both coding RNAs and proteins. There are over 200,000 RNA transcripts in the human transcriptome – a vast pool of potential therapeutic targets. Yet today’s small-molecule medicines address approximately 500 protein targets in a small number of structural classes. Accessing the biology embodied by the rest of the transcriptome has required the development of new therapeutic modalities, such as oligonucleotide drugs and gene therapies, which are at the early stages of their clinical evolution. Arrakis intends to open RNA biology to medicines with the attractive and predictable pharmaceutical properties of small-molecule drugs, including oral bioavailability, broad biodistribution, and efficient cell penetration.

“The importance of targeting RNA in disease is well recognized,”

said Russell C. Petter, Ph.D., founder and CSO of Arrakis Therapeutics.

“But until now, targeting RNA with small-molecule compounds has been thought to be too challenging. Nevertheless, there are a number of precedents for conventional small molecules that bind and modulate RNA, including several approved drugs. These molecules were all discovered in functional screens, and only later did we learn that they acted on RNA. Our goal is to intentionally discover RNA-modulating small-molecule medicines. We believe that new developments in informatics, structural biology, and biophysical tools now make that possible.”

Colleen Cuffaro, Ph.D., principal at Canaan, who is joining the Arrakis board said,

“Arrakis is pursuing a fundamentally different approach to RNA targets. For decades, the pharmaceutical industry has invested billions of dollars to develop tools and techniques to create drugs for protein targets. Arrakis is building on this toolkit to create a platform to discover RNA-targeted drugs. In doing so, I believe Arrakis has the potential to create an entirely new class of medicines for patients with unmet need.”

Industry-leading Experts on Management Team and Board

Arrakis has assembled an executive team and board of directors comprised of industry veterans with established records of building successful biopharmaceutical companies.

The Arrakis senior management team is comprised of the following:

  • Michael Gilman, Ph.D., CEO and chairman of Arrakis; former founding CEO of Padlock Therapeutics and Stromedix, as well as executive roles at Biogen and ARIAD Pharmaceuticals
  • Russell C. Petter, Ph.D., founder and chief scientific officer of Arrakis; former executive roles at Celgene, Avila, Mersana, Biogen, and Sandoz/Novartis
  • Daniel Koerwer, chief business officer of Arrakis; former executive roles at BIND and Biogen
  • James Barsoum, Ph.D., senior vice president of biology of Arrakis; former executive roles at RANA, Synta, and Biogen

Raj Parekh, Ph.D., founder of Arrakis and general partner at Advent Life Sciences said, “Our investor syndicate is a collaborative team committed to supporting Arrakis’ pioneering approach, and providing the company theresources needed to bring transformative new drugs to patients.”

The Arrakis board of directors is comprised of the following:

  • Michael Gilman, Ph.D., CEO and chairman of Arrakis Therapeutics
  • Colleen Cuffaro, Ph.D., principal at Canaan Partners
  • Carolyn Green, executive director of strategic investments, External R&D Innovation, Pfizer Worldwide Research & Development
  • Raj Parekh, Ph.D., founder of Arrakis Therapeutics and general partner at Advent Life Sciences
  • Alan Walts, Ph.D., founder of Arrakis Therapeutics and venture partner at Advent Life Sciences

Observers on the Arrakis board of directors are Tim Shannon, M.D., general partner at Canaan Partners; Elaine Jones, Ph.D., VP of Pfizer Ventures; Peter Worland, Ph.D., VP Integrative Research Development at Celgene; and Matthew Cohen, Ph.D., principal at Osage University Partners.

About Arrakis Therapeutics

Arrakis Therapeutics is a biopharmaceutical company pioneering the discovery of a new class of medicines that directly target RNA. The company’s TRYST™ and PEARL-seq™ platforms identify new RNA targets and drug candidates to treat diseases unaddressed by today’s medicines. Arrakis is developing a proprietary pipeline of RNA-targeted small molecules focused on neurologic diseases, cancer, and rare genetic diseases.

Arrakis was founded in 2015 by Russell Petter, Ph.D., Alan Walts, Ph.D., Henri Termeer and Raj Parekh, Ph.D. with a vision to create a proprietary, transformational discovery platform that identifies small-molecule drugs that act directly on disease-causing RNA.  The company was established with seed funding provided by Advent Life Sciences and Henri Termeer.  The company brings together scientific leaders in RNA structure, chemistry and biology, along with a highly experienced management team and the backing of leading life sciences investors. The company is located in Waltham, Mass.  Please visit www.arrakistx.com.

About Advent Life Sciences

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

About Canaan Partners

Canaan Partners is an early stage venture capital firm that invests in entrepreneurs with visionary ideas.  With $4.2 billion under management, a diversified fund and 190 exits to date, Canaan has invested in some of the world’s leading technology and health care companies over the past 30 years. Canaan’s focus areas include fin tech, enterprise/SaaS, marketplace, e-commerce, biopharma, digital health and medtech.  To learn more about our people and our portfolio, please visit canaan.com.

About Pfizer Inc.

At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products. Our global portfolio includes medicines and vaccines as well as many of the world’s best-known consumer health care products. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world’s premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 150 years, Pfizer has worked to make a difference for all who rely on us. For more information, please visit us at www.pfizer.com.

About Celgene Corporation

Celgene Corporation, headquartered in Summit, New Jersey, is an integrated global biopharmaceutical company engaged primarily in the discovery, development and commercialization of innovative therapies for the treatment of cancer and inflammatory diseases through next-generation solutions in protein homeostasis, immuno-oncology, epigenetics, immunology and neuro-inflammation. For more information, please visit www.celgene.com.

About Osage University Partners

Osage University Partners is a venture capital firm focused on investing in startups that are commercializing pioneering university technologies. Osage partners with top research universities to invest in their most innovative startups, and Osage shares its investment profit with its partner institutions. The firm invests in software, hardware, and life science companies at all stages of company development. Osage has partnered with over 80 universities, including 36 of the top 50 U.S. institutions by research expenditures, and has invested in over 60 of their spinouts. Osage University Partners is part of a family of investment funds within Osage Partners, which is based in Philadelphia, PA and manages in excess of $500 million. For more information, visit www.osageuniversitypartners.com.

Contact:
Kathryn Morris
The Yates Network
Tel:  845-635-9828
kathryn@theyatesnetwork.com