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May 19
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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
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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
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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
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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

Jan 05
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NeRRe Therapeutics raises £23 million in oversubscribed Series B financing round

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

 

New funds to advance unique neurokinin receptor antagonist pipeline towards late-stage clinical development in common, chronic and debilitating respiratory and women’s health conditions.

New investors Fountain Healthcare Partners, Forbion Capital Partners and OrbiMed join existing investors Advent Life Sciences and Novo A/S

Stevenage, UK, 5th January 2017 – NeRRe Therapeutics (‘NeRRe’), a clinical-stage company developing a unique portfolio of neurokinin (NK) receptor antagonists for the treatment of common, chronic and debilitating conditions caused by neuronal hypersensitivity, announced it has raised £23 million in an oversubscribed Series B financing round.

The funds will be used by NeRRe to generate Phase 2 data on orvepitant, its lead oral NK-1 antagonist candidate as a potential new treatment for a common, chronic respiratory condition; and to advance NT-814, a dual NK-1,3 antagonist, into Phase 2 trials as a potential non-hormonal treatment of distressing post-menopausal vasomotor symptoms.

The financing round involved a syndicate of leading transatlantic life sciences investors led by new investor Fountain Healthcare Partners, and co-led by Forbion Capital Partners and OrbiMed. Existing investors, Advent Life Sciences and Novo A/S also participated.

Dr Ena Prosser, Partner at Fountain Healthcare Partners; Geert-Jan Mulder MD, General Partner at Forbion Capital Partners; and Dr Iain Dukes, Venture Partner at OrbiMed will join Dr Kaasim Mahmood, General Partner at Advent Life Sciences (Chairman), Dr Mary Kerr, NeRRe’s CEO and Jo Craig, Vice-President GSK (Board Observer) on the NeRRe Board of Directors.

OrbiMed’s Iain Dukes, formerly Senior Vice President, Business Development & Licensing at Merck & Co., said:

“We have been impressed by NeRRe’s clear strategy, and are pleased to be involved in funding the company to deliver important Phase 2 clinical data on both of these exciting candidates. We look forward to supporting the company in achieving these aims.”

Mary Kerr, NeRRe’s CEO, said:

“NeRRe is delighted to have attracted such a substantial investment from these high profile life sciences investors. Now that we are fully funded to execute the next phase of development, everyone at the company is focused on moving orvepitant and NT-814 closer to the market for the alleviation of these common, chronic and debilitating conditions.”

*Biographies of the Board of Directors can be found at www.nerretherapeutics.com

Notes to Editors

About NeRRe Therapeutics (www.nerretherapeutics.com)

NeRRe Therapeutics is a private, UK-based clinical-stage company focused on the development of its unique portfolio of NK receptor antagonists for the treatment of common, chronic and debilitating conditions caused by neuronal hypersensitivity.

NeRRe Therapeutics was founded in 2012 as a spin out from GSK, which transferred its NK antagonist portfolio, including clinical data, toxicity, safety and formulation packages, and all associated IP to NeRRe. NeRRe 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 is backed by leading international life sciences investors: Advent Life Sciences, Fountain Healthcare Partners, Forbion Capital Partners, OrbiMed, and Novo A/S.

NeRRe is based at the state-of-the-art Stevenage Bioscience Catalyst (www.stevenagecatalyst.com), the UK’s first open innovation bioscience campus.

About Fountain Healthcare Partners
Fountain Healthcare Partners is a life science focused venture capital fund with €176 million ($200 million) under management. Within the life science sector, specific areas of interest to Fountain include specialty pharma, medical devices, biotechnology and diagnostics. The firm deploys the majority of its capital in Europe, with the balance in the United States. Fountain’s main office is in Dublin, Ireland, with a second office in New York. www.fh-partners.com

About Forbion Capital Partners
Forbion Capital Partners is a dedicated life sciences venture capital firm with offices in The Netherlands and Germany. Forbion invests in life sciences companies in the pharmaceutical, as well as the medical device space. Forbion’s investment team has built an impressive performance track record since the late nineties with successful investments in multiple companies. With the new FCFIII fund, Forbion manages well over EUR 700M across six funds, including the new fund FCF III. Its investors include the EIF through its European Recovery Programme (ERP), LfA and Dutch Venture Initiative (DVI) facilities and the KFW through the ERP – Venture Capital Fondsfinanzierung facility. Forbion also operates a joint venture with BioGeneration Ventures, who manages two separate seed and early stage funds focused on Benelux. For further information please visit www.forbion.com.

About OrbiMed
OrbiMed is a leading investment firm dedicated exclusively to the healthcare sector, with over $14 billion in assets under management. OrbiMed invests globally across the spectrum of healthcare companies, from venture capital start-ups to large multinational companies utilizing a range of private equity funds, public equity funds, royalty/debt funds and other investment vehicles. OrbiMed maintains its headquarters in New York City, with additional offices in San Francisco, Shanghai, Mumbai and Herzliya. www.OrbiMed.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 16 professionals, each with extensive scientific, medical and operational experience, a long-standing record of entrepreneurial and investment success in the US and Europe, and is particularly focused on supporting entrepreneurs and founders to take innovative new medical entities from concept to approval. The Firm invests in a range of sectors within life sciences, principally drug discovery, enabling technologies and med tech, always with an emphasis on innovative, paradigm-changing approaches. Advent Life Sciences has a presence in the UK, US and France. For more information, please visit www.AdventLS.com

For more information, please contact:

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

Katja Stout/Mark Swallow, Citigate Dewe Rogerson
Tel: +44 20 7282 1066/2948
Email: NeRRe@citigatedr.co.uk

Sep 29
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Aura Biosciences Secures $8 Million in Additional Funding

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

 

Aura Biosciences Secures $8 Million in Additional Funding and Augments Board of Directors and Clinical Advisory Board

September 29, 2016

Proceeds will support clinical development of the company’s lead program in ocular melanoma

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 secured an additional $8 million round of funding. The company also announced the addition of Henri Termeer, former CEO of Genzyme and major Aura investor, to its Board of Directors, and welcomed key new Clinical Advisory Board (CAB) members, all distinguished ocular oncologists.

The round of financing consisted of expanded funding commitments from its existing investors:  Advent Partners, Chiesi Ventures, Ysios Capital, Alexandria Venture Investments and several individual investors, including Termeer. Proceeds from the financing will be used to advance to the clinic Aura’s lead program in ocular melanoma (OM), AU-011, which is the first targeted therapy ever to be developed for the primary treatment of this rare and life-threatening disease. AU-011 has been granted orphan drug designation by the U.S. Food and Drug Administration and is expected to enter clinical testing early next year.

“Since the closing of our Series B financing over a year ago, we’ve made significant strides toward our ultimate goal of creating a safe and effective therapy that selectively eliminates cancer cells early in the OM disease course, while preserving vision for these patients,”

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

“With the continued support of our investors, experienced clinical advisors and Board of Directors, we are moving AU-011 rapidly toward the clinic, while additionally advancing our preclinical programs in other indications where Aura’s approach of selective tumor targeting could revolutionize treatment for patients with rare cancers who have no other treatment options.”

To help guide the company’s clinical program, Aura has also expanded its CAB with two new members who are recognized world leaders in the diagnosis and treatment of patients with OM and other ocular cancers:

  • Jay S. Duker, M.D., Director of the New England Eye Center and Professor and Chairman of the department of ophthalmology at Tufts Medical Center and the Tufts University School of Medicine in Boston
  • Brian Marr, M.D., Associate Professor of Ophthalmology at Weill-Cornell Medical School, and Associate Attending and key member of the ophthalmic oncology service, department of surgery at Memorial Sloan-Kettering Cancer Center

Founding members of Aura’s CAB, which was formed last year, are world-renowned ocular oncology specialists Carol Shields, M.D., Evangelos Gragoudas, M.D., and Arun Singh, M.D. José Baselga, M.D., Ph.D., Physician-in-Chief and Chief Medical Officer at Memorial Sloan Kettering Cancer Center, is the Chairman of Aura’s CAB. Additional members include Miguel Burnier, Jr., M.D., Ph.D., Richard Carvajal, M.D., and Richard Peters, M.D., Ph.D.

About Aura Biosciences

Aura Biosciences is developing a new class of therapies to target and selectively destroy tumor cells. Its lead program in ocular melanoma, developed under a CRADA with the National Cancer Institute (NCI), has been granted orphan drug status by the US Food and Drug Administration. For more information, visit www.aurabiosciences.com.

Media Contact

Ann Stanesa, 617-230-0347

Ten Bridge Communications

ann@tenbridgecommunications.com  

Jun 20
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F2G Ltd Announces $60 Million Financing to Progress Development of Novel Antifungal Agents

By F2G, Press Release, Private Companies
Press Release.

 

Funding to Take Lead Compound Through to Product Approval and Development of Pipeline Assets

MANCHESTER, UK – 20 June 2016 – F2G Ltd, the UK-based antifungal drug discovery and development company, today announced that it has raised $60 million in financing to develop its pipeline of novel therapies to treat life threatening invasive fungal infections. The round was led by Sectoral Asset Management, with participation from Novo A/S, Aisling Capital and Brace Pharma Capital. Existing investors Advent Life Sciences LLP, Novartis Venture Fund, Sunstone Capital and Merifin Capital each participated in the round.

F2G has discovered and developed a completely new class of antifungal agents called the orotomides. The orotomides are active against Aspergillus and other rare and resistant moulds and act via a completely different mechanism than currently marketed antifungal agents. Existing antifungal therapies have known safety limitations and between 10-30% of patients cannot tolerate any initial given therapy. Due to their new mechanism of action, orotomides are active against infections resistant to current therapies, a growing problem globally.
F2G plans to advance its lead compound, F901318, a novel clinical stage candidate for the treatment of invasive aspergillosis and other serious rare mould infections, to completion of a pivotal registration study, and to further develop earlier stage assets in its pipeline. Aspergillosis is a serious pulmonary infection caused by Aspergillus, a common fungus that affects people with weakened immune systems or lung diseases.

Ian Nicholson, Chief Executive Officer, F2G Ltd commented:

“F2G has made significant progress in the last 12 months and this financing, achieved in a tough funding environment, demonstrates investor confidence in our novel class of therapies and outstanding team. We welcome our new investors to the company and thank our existing investors for their continuing support and confidence in our team and strategy. We are now well positioned to achieve our goal of product approval in an area with significant unmet medical need and look forward to conducting our pivotal registration study.”

Dr Maha Katabi, Private Equity Partner, Sectoral Asset Management added:

“We look forward to working with the F2G team and a high quality venture capital syndicate to bring an important medicine to patients with life-threatening fungal infections. We have been impressed by the progress that F2G has made to date and are pleased to support its next phase of growth.”

Dr Maha Katabi, Private Equity Partner at Sectoral Asset Management and Dr Martin Edwards, Senior Partner at Novo A/S will join the F2G Board of Directors.

About F2G Ltd: F2G is a world leading UK biotech company focused on the discovery and development of novel therapies to treat life threatening invasive fungal infections, with experienced management & board. F2G has discovered and developed a completely new class of antifungal agents called the orotomides. The orotomides are active against Aspergillus and other rare and resistant moulds and act via a completely different mechanism than currently marketed antifungal agents. Due to their new mechanism of action, orotomides are active against fungal infections resistant to current therapies, a growing problem globally. A small PK Phase 2 clinical trial for F901318 is planned for 2H 2016 with pivotal registration trials in Invasive Aspergillosis planned for 1H 2017 based on an accelerated regulatory pathway agreed with the relevant agencies. F901318 is being developed both as IV and oral formulations and promises to have a safe and well-tolerated profile.

Contact:
F2G Ltd
Ian Nicholson | Chief Executive Officer
inicholson@f2g.com | +44 (0)161 785 1271 | www.f2g.com

Hume Brophy
Mary Clark, Supriya Mathur
f2g@humebrophy.com | +44 (0)207 862 6475

Mar 22
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Acutus Medical Completes $75 Million Series C Financing

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

 

  • Expands Existing Blue Chip Syndicate with Institutional and Strategic Investors.
  • Financing Will Support Quest to Transform EP Market by Expanding Clinical Studies and Upcoming European and U.S. Launches of AcQMap™ High Resolution Imaging and Mapping System.

CARLSBAD, CA—March 22, 2016—Acutus Medical, an electrophysiology company committed to transforming how electrophysiologists (EPs) image, diagnose and treat complex arrhythmias, today announced that the company has closed a $75 million Series C financing. The all-equity financing round included new investors Deerfield Management Company, Xeraya Capital and an undisclosed strategic investor. Also participating in the round were existing Acutus Medical investors Advent Life Sciences, which has been an investor in the company since its inception along with OrbiMed and GE Ventures, which joined in the B-series.

“The Acutus Medical AcQMap™ technology has the potential to play an important role in the detection and treatment of atrial fibrillation (AFIB),”

said Steve Hochberg, partner at Deerfield.

“Presently, EPs are only able to map the inside of the heart chamber by actually touching the heart wall with a catheter one location at a time. This limitation prevents the EP from truly seeing the AFIB in a complete, full chamber, high-resolution view, leading them to treat the patient via an empirically-based approach versus an evidence-based approach. AcQMap allows EPs, for the first time, to see a three dimensional, high-definition view of the heart chamber and its electrical activity in real-time, helping them to make critical treatment decisions based on clear evidence of the abnormality causing the arrhythmia.”

 

The key differentiator of the AcQMap High Resolution Imaging and Mapping System is its ability to truly map AFIB and other complex arrhythmias, identify the mechanism of those arrhythmias, and provide a guide for ablation therapy. In addition, AcQMap can show the EP the effectiveness of the therapy in real-time. After the ablation has been delivered and upon the next heartbeat, a new complete map is rendered to confirm how the therapy changed the electrical pattern inside the heart. This real-time feedback loop can continue until the EP is satisfied that the therapy and the procedure have been successful.

Proceeds from the Series C financing will allow Acutus to continue to develop the entire suite of AcQMap products necessary to perform any catheter-based procedure, expand its clinical programs worldwide and continue developing a U.S. and European sales force in preparation for commercialization in both geographies.

“The rapid pace of progress in the past few years has brought Acutus from an early stage start-up to a company on the verge of a commercial launch,”

said Randy Werneth, president and chief executive officer of Acutus Medical.

“That progress has energized our existing syndicate of top-tier investors and financial partners, while attracting the participation of new, world-class investors to participate in the next critical stages of the company. Their support and shared vision for the company are essential for us to complete our regulatory and clinical milestones in preparation for commercialization.”

About Acutus Medical

Acutus Medical is a global heart rhythm technology company transforming the way electrophysiologists (EPs) diagnose and treat cardiac arrhythmias. The company is currently pursuing CE mark approval in Europe for the full suite of AcQMap™ System products. 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

 

Julia Baron

Pure Communications, Inc.

(858) 692-2001

Julia@purecommunicationsinc.com

 

Investor Contact

 

Matt Clawson

Pure Communications, Inc.

(949) 370-8500

Matt@purecommunicationsinc.com

Mar 08
Love0

Antibody firm Capella raises $15.5M for novel targets, good biology

By Press Release
Press Release.

 

LONDON – The U.K.’s latest antibody company, Capella Biosciences Ltd., announced the closing of an £11 million (US$15.5 million) series A round, providing the funding to take the lead program through to phase IIa development by the end of 2018, and to complete preclinical development of four other products.

That follows an initial investment of £1.5 million seed funding in 2014, with which, rather than shaping up an existing body of academic research, Capella Chief Operating Of cer (COO) Steve Holmes was charged to go out and prospect for five therapeutic antibody projects around which to form a company. The seed money came from the founding investors, Advent Life Sciences and Medicxi Ventures (then Index Ventures). As Holmes explained, the idea was to draw on his experience, and that of the VC backers, to select the best monoclonal antibody projects.

“The key was the targets; they had to be novel, and to have good biology to go with them,”

Holmes said.

Antibody generation has now advanced to the point where a number of platforms are available and in that sense products are commoditised.

“We are agnostic about platforms. Making antibodies is relatively straightforward; it is the targets that make the difference,”

Holmes told BioWorld Today.

“[Products] could be fully human or mouse, it depends what we want to get out of the antibody,”

he said.

From initial prospecting in 2014, London-based Capella has advanced to the point of having lead panels of antibodies for its top three programs and has in-licensed target biology for a further two programs.

The first program, in in amatory bowel disease, rests on research from Sanford Burnham Prebys Medical Discovery Institute in La Jolla, Calif. Although not revealing any details, Holmes said that is a known target in which Capella is aiming at a particular aspect of the biology that has not been exploited previously.

“It happens to be a difficult concept for developing an antibody, but we’ve got initial [constructs],”

Holmes said. The second program, in fibrosis, is based on intellectual property from Leeds University.

If target biology is now the key to antibody drug development, the central requirement in its selection is expertise in therapeutic targets.

Holmes has some form here, being former COO of murine antibody company Kymab Ltd. and of Domantis Ltd., and heading the monoclonal antibody group at Smithkline Beecham plc and then Glaxosmithkline plc, during the pioneering decade from 1990 to 2001. Capella’s clinical and scientific advisory group include antibody doyen Don Drakeman, founder of two leading U.S. and European companies, Medarex Inc. (acquired by Bristol-Myers Squibb Co. for $2.4 billion in 2009) and Genmab A/S. Meanwhile, Kevin Johnson, partner at Medicxi and board member at Capella, was head of research at Cambridge Antibody Technology plc, a corporate foundation stone of the monoclonal antibody therapeutics sector.

In addition to reflecting the maturity and quality of monoclonal antibody platforms, Capella exemplifies the asset-based investment strategies of the founding VCs. Rather than making an initial investment in forming a company, the two invest in taking on half-formed assets and shaping them up to be suitable for pharma pipelines. The focus then is on conducting a program of research that will validate – or not – a particular asset, with the aim of establishing proof of concept in around three years for an investment of around $20 million.

“The intention with our five therapeutic monoclonal antibodies, is quick in, quick out. This is a really good model for a start-up; we have been completely funded by Advent and Medicxi from nothing,”

Holmes said.

“In fact, we started one program and dropped it after five months and found a substitute – so we are very lethal. But with the last five targets everything has worked,”

said Holmes.

The intention will be to and commercialization partners at an early stage, and Holmes said he expects to be ready to start the hunt for partnerships before the end of the year. The profile and connections of the investors and the board means Capella “can go straight to the top” when trying to attract big pharma, he added.

Joining the founding investors Advent and Medicxi in the series A is Philadelphia-based Osage University Partners, a VC specializing in the commercialization of academic research.

The series A investment in Capella is Medicxi’s rst since splitting from Index Ventures and launching a new $250 million fund dedicated to early stage European research in February.

Feb 08
Love0

Medical device apparel innovator Vestagen completes financing and hires new CEO

By Press Release
Press Release.

 

  • Funds to Support Commercialization of VESTEX® Active Barrier Healthcare Apparel Proven to Reduce Acquisition and Retention of Dangerous Contaminants
  • New CEO Bill Bold Has Two Decades of Leadership in Growing Successful Medical Device Firms
  • New Sales Leader Jim Beyer is Accomplished Executive Bringing Extensive Experience In Selling New Medical Technologies

 

ORLANDO, FL – February 8, 2016 – Vestagen Technical Textiles, Inc., a medical technology company developing and marketing high performance apparel for healthcare and other demanding applications, today announced it has named Bill Bold Chief Executive Officer. He replaces Dale Pfost, PhD, who was serving as interim CEO and remains Chairman. Mr. Bold is also joining Vestagen’s Board of Directors.

The company also reported that it has completed a $7.0 million financing, which was a planned extension of its previous financing. Advent Life Sciences and HealthQuest Capital led the financing, and other Vestagen investors also participated. The proceeds will support commercialization of VESTEX®, the first in a new class of active barrier technologies that combines fluid repellent, antimicrobial and breathability properties. VESTEX is the only daily-use textile proven in a hospital setting to reduce harmful contaminants on garments, with the aim of reducing the risk of spreading dangerous pathogens.

Dr. Pfost noted.

“Bill has an outstanding record of successfully developing and commercializing novel medical devices that address new markets, including navigating the FDA review process and winning adoption of new technologies by large customers. He will be ably assisted by the highly experienced team we have assembled, including newly hired senior sales executive Jim Beyer, who has generated exponential growth for innovative medical devices in his previous positions.”

Dr. Pfost continued,

“We want to thank our investors for their continuing support. We will soon be expanding our product line and filing for FDA review of VESTEX as a protective medical device. These are exciting times for Vestagen, and we look forward to rapid progress going forward.”

Mr. Bold commented,

“Healthcare uniforms have been linked to the potential spread of dangerous pathogens. Vestagen is addressing the unmet need for better worker and patient safety with its game-changing VESTEX products and technologies, which transform everyday healthcare apparel into a protective medical device. Our scrubs are also comfortable, attractive and affordable. Vestagen’s commitment to evidence-based marketing and regulatory review distinguishes its strategy and provides us with a key competitive advantage. I look forward to working with the talented Vestagen team.”

Mr. Bold was formerly President and CEO at Vascular Pathways, where he headed a turnaround that resulted in its successful acquisition by CR Bard. During his tenure Mr. Bold developed and commercialized three FDA-approved products for new markets. Previously, he held senior leadership positions at catheter securement device maker Venetec International, where he helped grow revenues ten-fold in five years, and at vascular device firm Access Scientific and healthcare supply chain exchange Medibuy.com.

Jim Beyer is an accomplished medical device sales executive with established industry relationships at major hospitals, group purchasing organizations and health systems. He most recently was Vice President of Corporate Sales at Masimo, a cutting edge developer of noninvasive patient monitoring technologies, where he led the development of multiple new channels that helped increase sales from $45 million to $600 million in eight years. Previously, Mr. Beyer held sales and marketing positions of increasing responsibility in the medical device industry. He began his career at VHA/Novation and Columbia/HCA.

About Vestagen and VESTEX®

Vestagen develops and markets advanced performance apparel products and technologies. Its VESTEX® active barrier protective technology is the first to combine fluid repellent, antimicrobial and breathability properties for everyday protection from unanticipated fluid exposure and pathogen transmission. VESTEX is clinically proven to prevent or reduce the acquisition and retention of contaminants on clothing, reducing methicillin-resistant Staphylococcus aureus (MRSA), by 99.99% compared to traditional uniforms. VESTEX is also comfortable, durable and affordable. Product lines, including lab coats, scrubs and patient apparel, are manufactured and sold directly by Vestagen, its retail partners and select distributors. VESTEX is suitable for a variety of applications, including healthcare, public safety and athletics and is available for use in garment production by approved licensees. For more information, visit www.vestagen.com.

 

Contacts

Corporate:

Marc Lessem

407-781-2570

 

Media:

BLL Partners

Barbara Lindheim

212-584-2276

blindheim@bllbiopartners.com