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Nov 11
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F2G Receives US FDA Breakthrough Therapy Designation for Olorofim

By F2G, Press Release, Private Companies
Press Release.

 

MANCHESTER, UK / VIENNA, Austria – November 11, 2019 – F2G Ltd, a UK- and Austria-based biotech company developing novel therapies for life-threatening systemic fungal infections, announced today that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to its lead first-in-class candidate, olorofim (formerly F901318) for the indication of ‘Treatment of invasive mold infections in patients with limited or no treatment options, including aspergillosis refractory or intolerant to currently available therapy, and infections due to Lomentospora prolificans, Scedosporium, and Scopulariopsis species’. Olorofim is the first antifungal agent to be granted Breakthrough Therapy designation.

Olorofim is currently being investigated in an open-label single-arm Phase 2b study (ClinicalTrials.gov Identifier: NCT03583164) in patients with proven invasive fungal disease (IFD) or probable invasive aspergillosis (IA) and either refractory disease, resistance, or intolerance to available agents. Olorofim has been well tolerated across more than 10 years of patient dosing days with a median therapy duration of 12 weeks. Preliminary data from this study were provided to the FDA as part of the Breakthrough Therapy designation submission.

Breakthrough Therapy designation is an FDA process designed to expedite the development and review of drugs that are intended to treat a serious or life-threatening condition and is granted based on preliminary clinical evidence indicating that the drug may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints.

Breakthrough Therapy designation conveys all the features of fast track designation, more intensive FDA guidance on an efficient drug development program, an organisational commitment by FDA to involve senior managers, and eligibility for rolling review and priority review.

Commenting on the news, Ian Nicholson, CEO of F2G Ltd, said:

“The granting of FDA Breakthrough Therapy designation is a truly transformational step for our company and will support our goal of rapidly developing this novel treatment for patients suffering from serious and life-threatening fungal infections. Olorofim acts via a novel and differentiated mechanism to traditional antifungals, and preliminary data have indicated that it is efficacious in tackling life-threatening invasive fungal infections that cannot be managed with currently approved agents.

“Our Phase 2b programme is on track with over 40 patients recruited in Europe, Australia and the US. We look forward to working closely with the FDA to accelerate development of this therapy for patients having limited or no approved treatment options for an invasive mold infection.”

Professor Sharon Chen, Westmead Hospital Sydney and Principal Investigator for the Phase 2b study said:

“This news is very exciting for clinicians caring for patients with these very serious, and devastating mold infections. We have had limited treatment options for many years and now the news about olorofim brings realistic hope that we can cure these previously treatment–refractory infections.”

Contact:
F2G Ltd
Ian Nicholson | Chief Executive Officer
Ralf Schmid | Chief Financial Officer
Tel: +44 (0)161 785 1271 (UK) / +43 (0)1 997 4267 (A)

Optimum Strategic Communications
Mary Clark / Supriya Mathur / Charlotte Hepburne-Scott
Email: F2G@optimumcomms.com
Tel: +44 (0) 203 950 9144

Notes to Editors:

About Olorofim / Clinical trial
The Phase 2b study for olorofim (ClinicalTrials.gov Identifier: NCT03583164) is a global open-label study in patients who have limited treatment options for difficult-to-treat invasive fungal mold infections such as azole-resistant aspergillosis, scedosporiosis, lomentosporiosis, and other rare mold infections. 26 centres are currently open in six countries (AU, BE, ES, NL, USA, IS) and a further 20 will open in 2019/2020. Olorofim is being developed both as IV and oral formulations.

About F2G
F2G is a world-leading UK- and Austria-based biotech company (F2G Ltd and F2G Biotech GmbH) focused on the discovery and development of novel therapies to treat life-threatening invasive fungal infections. F2G has discovered and developed a completely new class of antifungal agents called the orotomides. The orotomides selectively target fungal dihydroorotate dehydrogenase (DHODH), a key enzyme in the de novo pyrimidine biosynthesis pathway. This is a completely different mechanism from that of the currently marketed antifungal agents and gives the orotomides fungicidal activity against a broad range of rare and resistant fungal mold infections. Olorofim (formerly, F901318) is F2G’s leading candidate from this class and is in a Phase 2b open-label study focussing on rare and resistant invasive fungal infections such as aspergillosis (including azole-resistant strains), scedosporiosis (including lomentosporiosis). Olorofim has received orphan drug status from the European Medicines Agency for the treatment of invasive aspergillosis and invasive scedosporiosis. Olorofim is being developed both as IV and oral formulations. www.f2g.com

Sep 09
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Axonics® Announces U.S. Food & Drug Administration Approval for its Sacral Neuromodulation System

By Axonics, Press Release
Press Release.

 

IRVINE, Calif.–(BUSINESS WIRE)– Axonics Modulation Technologies, Inc. (NASDAQ: AXNX), a medical technology company that has developed and is commercializing a novel implantable rechargeable sacral neuromodulation (“SNM”) device for the treatment of urinary and bowel dysfunction, today announced the approval of the Axonics r-SNM® System by the United States Food & Drug Administration (“FDA”). The Axonics System is the first rechargeable SNM system approved for sale in the United States, Europe, Canada and Australia.

The FDA approval grants Axonics the right to market its product in the United States for the clinical indication of fecal incontinence. The approval includes the claim of a 15-year functional life and the ability of patients to undergo full-body MRI scans without the necessity of having the device explanted.

Axonics has an additional pre-market approval (“PMA”) filing currently under review with the FDA for the clinical indications of overactive bladder (urinary urgency incontinence and urinary urgency frequency) as well as urinary retention for which the Company anticipates a determination in the near term.

Raymond W. Cohen, CEO of Axonics, commented,

“If we consider the millions of women who are suffering in silence with bladder and bowel dysfunction, we believe the market opportunity for Axonics goes well beyond the existing approximately $650 million of revenue that is currently being generated by the incumbent’s non-rechargeable SNM device. We believe the number of patients seeking SNM treatment will expand dramatically over the next few years given our fuss-free, long-lived, full body MRI-compatible device. In the months prior to FDA approval, we invested significant time and resources in building inventory to support our fully trained, U.S. commercial team which now includes 145 territory managers, clinical support specialists and sales managers strategically located around the country. We plan to begin shipping product to U.S. physicians and hospitals during the fourth quarter of 2019, following the fulfillment of customary, pre-launch regulatory requirements.”

About Sacral Neuromodulation and the Axonics r-SNM System

Sacral neuromodulation is used to treat bladder and bowel dysfunction. These conditions are caused by a miscommunication between the bladder and the brain and significantly impacts quality of life. Overactive bladder affects an estimated 87 million adults in the U.S. and Europe. Another estimated 40 million adults are reported to suffer from fecal incontinence/accidental bowel leakage. SNM therapy has been employed to reduce symptoms and restore pelvic floor function for the past two decades. Reimbursement coverage is well established in the U.S. and Europe. The Axonics r-SNM System is the first rechargeable SNM system approved for sale in the world, and the first to gain full-body MRI conditional labeling. The Axonics r-SNM System offers a long-lived miniaturized neurostimulator that is approximately the size of a USB stick and is qualified to last 15 years in the body as compared to the incumbent’s device which is non-rechargeable and requires patients to undergo a surgical intervention to replace the device every 3 to 5 years. In addition to full body MRI conditional labeling, the Axonics r-SNM System features many differentiating attributes. These include a patented tined lead, user-friendly accessories, a wireless charging system optimized for infrequent charging, a small easy-to-use patient remote control and an intuitive clinician programmer that facilitates lead placement and stimulation programming.

PMA approval process with the U.S. FDA

Determination by the FDA of the safety and effectiveness of the Axonics r-SNM System was supported by the results of a detailed review of technical data, published SNM clinical literature and the ARTISAN-SNM 129-patient pivotal clinical study. ARTISAN-SNM was conducted at 14 centers in the U.S. and five centers in Western Europe and met all primary and secondary endpoints. No serious device-related adverse events were reported. During the review period the FDA conducted two detailed PMA audits of the Axonics quality system and manufacturing. The audits were completed without any negative observations.

Conference Call and Webcast

The Company will host a conference call with the investment community to discuss the FDA approval and recent business developments, on September 9, 2019, at 9:00 a.m. Eastern Time.

Interested parties may access the live call via telephone by dialing (866) 687-5771 (U.S.) or (409) 217-8725 (International) and using passcode 3147028. A live webcast of the call may be accessed by visiting the Events & Presentations page of the investors section of the Company’s website at ir.axonicsmodulation.com. A replay of the webcast will be available shortly after the conclusion of the call and will be archived on the Company’s website for 90 days.

About Axonics Modulation Technologies, Inc.

Axonics, based in Irvine, CA, has developed and is commercializing a novel implantable SNM device for patients with urinary and bowel dysfunction. For more information, visit the Company’s website at www.axonicsmodulation.com

Forward-Looking Statements

Statements made in this press release that relate to future plans, events, prospects or performance are forward-looking statements as defined under the Private Securities Litigation Reform Act of 1995. Words such as “planned,” “expects,” “believes,” “anticipates,” “designed,” and similar words are intended to identify forward-looking statements. While these forward-looking statements are based on the current expectations and beliefs of management, such forward-looking statements are subject to a number of risks, uncertainties, assumptions and other factors that could cause actual results to differ materially from the expectations expressed in this press release, including the risks and uncertainties disclosed in Axonics filings with the Securities and Exchange Commission, all of which are available online at www.sec.gov. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Except as required by law, Axonics undertakes no obligation to update or revise any forward-looking statements to reflect new information, changed circumstances or unanticipated events.

View source version on businesswire.com: https://www.businesswire.com/news/home/20190909005226/en/

Contacts

Axonics’ Contact
Axonics Modulation Technologies, Inc.
Dan Dearen, +1-949-396-6320
President & Chief Financial Officer
ir@axonics.com

Investor & Media Contact
W2Opure
Matt Clawson, +1-949-370-8500
mclawson@w2ogroup.com

Source: Axonics Modulation Technologies, Inc.

Apr 26
Love0

Acutus Medical’s New Contact Mapping Software Receives CE Mark

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

 

FDA Clears Robust Second Generation AcQMap Platform

CARLSBAD, Calif. and MANNHEIM, Germany, April 26, 2019 – Acutus Medical today announced CE mark approval for AcQMap contact mapping software, offering expanded functionality that provides physicians with more options to inform individualized patient therapy. The company also announced FDA clearance of its second generation AcQMap platform. All AcQMap systems retain the unique ability to quickly reconstruct atrial anatomy using ultrasound and map electrical patterns using non-contact, charge density technology, creating ultra-high-resolution 3D images in real time.
AcQMap enables physicians to uncover the electrical activation pattern of the heart with real-time visualization during electrophysiology procedures.

“The contact mapping speed with the new Acutus system was extremely fast, which made it very easy to use,”

said Dr. Christian Meyer, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.

“Clinically, having this capability available on one system that also does non-contact mapping allows me to do exactly what makes sense case-by-case. For routine cases, my treatment strategy can be confirmed using conventional mapping catheters. In more complex cases, such as atrial fibrillation, I can gather more comprehensive data about each patient’s anatomy and arrhythmia in real time with the non-contact charge density catheter, making AcQMap the complete atrial mapping solution.”

Cardiac ablation treatment can improve quality of life for patients with atrial arrhythmias such as atrial fibrillation (AF). AF affects more than 33 million people globally and increases the risk of stroke and heart failure.1,2 AcQMap enables physicians to uncover the electrical activation pattern of the heart with real-time visualization during electrophysiology procedures. With non-contact mapping, physicians see full-chamber, continuous beat-by-beat arrhythmia conduction and can locate arrhythmias outside the pulmonary veins to inform their treatment strategy, enabling an iterative map-ablate-remap approach.

“With the introduction of contact mapping software in Europe, AcQMap is unquestionably the most agile and comprehensive cardiac imaging and mapping system available, offering full spectrum arrhythmia visualization in under three minutes. No other technology offers the suite of solutions incorporated into AcQMap,”

said Acutus Medical CEO Vince Burgess.

“Our second generation system is engineered to be the cornerstone platform for electrophysiology labs for many years to come. We worked alongside physician partners to understand complex challenges and simple needs to improve the efficiency and safety of electrophysiology procedures. This next-gen AcQMap system has the capability to exponentially improve the day-to-day clinical utility of cardiac mapping and deliver long-term value by offering health systems a comprehensive solution for electrophysiologists and their patients.”

Acutus Medical’s contact mapping software is compatible with both first and second generation AcQMap platforms and will be installed on all European systems in Q3. The second generation AcQMap system is built to support future software innovations and will be available in the U.S. in Q3.

About Acutus Medical
Acutus Medical is a dynamic arrhythmia care company focused on developing distinct, innovative technologies that provide physicians and patients with improved results. At Acutus, we know that seeing is better than believing. Diagnosing and treating patients with atrial arrhythmias requires eliminating the unknown. Acutus’ advanced cardiac imaging and mapping system provides real-time arrhythmia visualization displaying the heart’s true activation pattern, turning the chaos of an atrial arrhythmia into a clear vision for electrophysiologists. Founded in 2011, Acutus is based in Carlsbad, California.

References
1 Staerk L, Sherer JA, Ko D, et al. Atrial Fibrillation. Circ Res 2017;120:1501-17. DOI: 10.1161/CIRCRESAHA.117.309732.
2 Chugh, S.S., Havmoeller, R., Narayanan, K. et al. Worldwide epidemiology of atrial fibrillation: a Global Burden of Disease 2010 Study. Circ Feb 25. 2014; 129: 837–847. DOI: 10.1161/CIRCULATIONAHA.113.005119.

Indications for Use
In the U.S., the AcQMap System is intended for use in patients for whom electrophysiology procedures have been prescribed. When used with the AcQMap Catheters, the AcQMap System is intended to be used to reconstruct the selected chamber from ultrasound data for purposes of visualizing the chamber anatomy and displaying electrical impulses as either dipole density-based or voltage-based maps of complex arrhythmias that may be difficult to identify using conventional mapping systems alone. And, when used with the specified Patient Electrodes, the AcQMap System is intended to display the position of AcQMap Catheters and conventional electrophysiology (EP) catheters in the heart.

In the EU, the AcQMap System is intended for use in patients for whom electrophysiology procedures have been prescribed. When used with the AcQMap Catheters, the AcQMap System is intended to be used in the right and/or left atria to visualize the selected chamber and display atrial electrical impulses. And, when used with patient electrodes, the AcQMap System is intended to display the position of AcQMap Catheters and conventional electrophysiology (EP) catheters in the heart. Or, when used with conventional electrophysiology catheters, the AcQMap System provides information about electrical activity of the heart and about catheter location during the procedure.

U.S. Media Contacts
Holly Winder
Head of Marketing & Communications
Acutus Medical
(503) 805-3683
holly.windler@acutus.com

Mackenzie Mohr / Jessica Stebing
Levitate
(260) 408-5383
acutus@levitatenow.com

Apr 18
Love0

Arrakis Therapeutics Announces $75 Million Series B Financing To Advance a New Class of Small-Molecule Medicines Targeting RNA

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

 

April 18, 2019

Michael Gilman, Ph.D., to expand role to full-time CEO to lead company to clinical stage
Having established first-in-industry RNA-targeted Small Molecule (rSM) platform, Arrakis will focus pipeline in oncology and genetically validated targets in other diseases
Financing led by venBio Partners and Nextech Invest

Waltham, Mass., April 18, 2019 – Arrakis Therapeutics, a biopharmaceutical company pioneering the discovery of a new class of small-molecule medicines that directly target RNA, has completed a $75 million Series B financing co-led by venBio Partners and Nextech Invest, with participation by new investors Omega Funds, HBM Healthcare Investments, GV (formerly Google Ventures), WuXi AppTec Venture Fund, and Alexandria Venture Investments, as well as all existing investors, Canaan Partners, Advent Life Sciences, Pfizer Ventures, Celgene Corporation, Osage University Partners and the estate of Henri Termeer. In addition, the company announced that Michael Gilman, Ph.D., will expand his role to full-time Chief Executive Officer in addition to continuing to serve as Chairman of the Board of Directors.

“With this financing and outstanding syndicate of investors, Arrakis will leap to the next stage of realizing our vision of creating a new class of medicines with RNA-targeted small molecules, or rSMs,”

said Dr. Gilman.

“We have built an end-to-end platform for the discovery of rSMs by creating or adapting tools that allow us to predict and validate the structure of RNA targets, locate druggable pockets, identify drug-like hits, and conduct medicinal chemistry programs to improve potency, selectivity, and safety. We are now operating this platform at scale to create a pipeline of utterly novel rSM medicines. I am excited to commit my full effort, along with the Arrakis team and our investors, to drive our discoveries into powerful new medicines for patients.”

The proceeds from the Series B financing will enable Arrakis to build a pipeline of novel RNA‑targeted small molecules, with the goal of reaching clinical testing with one or more candidates. The company will focus its internal drug development in oncology and genetically validated targets in other disease areas. In addition, the funding will enable Arrakis to continue to refine and expand its first-in-industry rSM discovery platform, including a high-throughput, comprehensive suite of computational tools, biophysical and cellular assays, and chemical libraries that are uniquely designed to create new small-molecule drugs for RNA targets.

“Arrakis Therapeutics is the clear leader in the emerging rSM field. We are pleased to support their differentiated strategy to transform the drug discovery toolkit to focus on RNA and open hundreds of important new targets to therapeutic intervention. Arrakis’ deeply experienced team is uniquely qualified to execute this strategy,”

said Richard Gaster, M.D., Ph.D., Principal at venBio Partners.

“The demand for more effective and better tolerated cancer drugs is high, creating the biggest and fastest growing market in healthcare. RNA is now a validated therapeutic target, and drugging RNA with conventional small-molecule medicines can provide cancer patients with options not achievable by any other means,”

said Jakob Loven, Ph.D., Partner at Nextech Invest.

In conjunction with the Series B financing, Dr. Gaster and Dr. Loven will join the Arrakis Board of Directors.

In its next stage of growth, Arrakis will employ its proprietary rSM drug discovery platform to discover novel RNA-targeted small molecules and advance lead candidates toward clinical testing. Since the company’s inception, Arrakis has systematically reconfigured drug discovery tools for RNA targets and achieved the following:

A systematic approach to identify and validate druggable RNA targets, enabling the company to target multiple aspects of RNA biology; these approaches include:

  • in silico tools to identify druggable RNA targets at scale;
  • high-throughput molecular biology tools to validate these targets.

Multiple screening methods for identifying tractable targets and chemical matter, including:

  • screening of hundreds of targets to date;
  • identification of druggable RNA binding pockets;
  • deriving the principles of molecular recognition of RNA.

Advancement of rSM drug programs against novel RNA targets and with strong intellectual property, including:

  • launch of four programs against RNA targets that encode proteins that are otherwise undruggable;
  • chemical biology tools to elucidate the mechanism of action and selectivity of drug candidates;
  • an intellectual property estate comprising new methods, compounds and targets.

About Arrakis Therapeutics
Arrakis Therapeutics is a biopharmaceutical company pioneering the discovery of a new class of medicines that directly target RNA. The company has developed a proprietary platform to identify new RNA targets and drug candidates to treat diseases unaddressed by today’s medicines. Arrakis is building a proprietary pipeline of RNA-targeted small molecules (rSMs) focused on cancer and genetically validated targets in other disease areas. 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, Massachusetts. Please visit www.arrakistx.com.

Apr 08
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F2G appoints Dr Patrick Vink as Chairman

By F2G, Press Release, Private Companies
Press Release.

 

Brings successful track record of building and growing global businesses

MANCHESTER, UK & VIENNA, AUSTRIA – 8 April 2019 – F2G Ltd, the European biotech company developing novel therapies for life-threatening fungal infections, today announces the appointment of Dr Patrick Vink as Chairman of the Board of Directors with immediate effect. Dr Vink replaces Dr Richard J. White who stood down in December 2018.

Dr Vink has over 30 years of experience in the biotechnology and pharmaceutical industry and has a successful track record of building and growing global pharmaceutical businesses.  He was previously Chief Operating Officer at Cubist Pharmaceuticals Inc, with responsibility for global commercial operations, and the development and implementation of long- and short-term strategy. During his term, Cubist was acquired by Merck & Co.  Prior to Cubist, he was Head of the Global Hospital Business at Mylan Inc. as part of the global executive team. Before this, he was Head of Global Biopharmaceuticals at Sandoz (division of Novartis) and held senior positions at Biogen Inc Sanofi-Synthelabo, and Numico.

Dr Vink is currently on the board of several US and European publicly listed and private companies including Chairman of Acacia Pharma, Targovax and NMD Pharma and non-executive director of Spero Therapeutics, Arch Biopartners and Santhera AG. Dr Vink has an MD from the University of Leiden and an MBA from University of Rochester. He has attended a number of executive post-graduate courses at Insead and Harvard.

Ian Nicholson, CEO of F2G Ltd, said:

“We are delighted to welcome Patrick to the Board. During his career, he has been responsible for several successful new product launches and held senior roles overseeing R&D, commercial and technical operations. His breadth and depth of experience will be invaluable as we accelerate the development of our lead candidate olorofim as a treatment for rare invasive fungal infections. On behalf of the Board of Directors I would like to thank Richard for his dedication, commitment and steadfast leadership during the evolution of F2G from discovery to late stage clinical development.”

Dr Patrick Vink, Chairman of F2G, added:

“I am very pleased to join as Chairman and look forward to working closely with the team. F2G’s highly experienced management team and board, backed by renowned and committed investors, will enable the company to drive forward the development of these novel antifungals which have the potential to make a real impact to patients with life-threatening fungal diseases.”

F2G recently raised funding from life science investor Morningside Venture Investments Ltd and received a EUR 24 million loan from the European Investment Bank (EIB).

Ian Nicholson, CEO and Ralf Schmid, CFO will be attending and presenting at the 18th Annual Needham Healthcare Conference at 10:40am EDT on April 10, 2019 in New York.

For further information please contact:

F2G Ltd
Ian Nicholson | Chief Executive Officer
Tel: +44 (0)161 785 1271
Ralf Schmid | Chief Financial Officer
Tel: +43 (0)1 997 4267 (Austria)

Optimum Strategic Communications
Mary Clark / Supriya Mathur / Ellie Blackwell
Email: F2G@optimumcomms.com
Tel: +44 (0) 203 950 9144

Notes to Editors

About F2G

F2G is a world leading European biotech company focused on the discovery and development of novel therapies to treat life-threatening invasive fungal infections. F2G has discovered and developed a completely new class of antifungal agents called the orotomides. The orotomides target dihydroorotate dehydrogenase (DHODH), a key enzyme in the de novo pyrimidine biosynthesis pathway. This is a completely different mechanism from that of the currently marketed antifungal agents and gives the orotomides fungicidal activity against a broad range of rare and resistant fungal mould infections. Olorofim (formerly, F901318) is F2G’s leading candidate from this class and is in a Phase 2b open-label study focussing on rare and resistant invasive fungal infections such as aspergillosis (including azole-resistant strains), scedosporiosis, and lomentosporiosis. Olorofim is being developed both as IV and oral formulations. www.f2g.com

Apr 02
Love0

Aura Biosciences Completes $40 Million Series D Financing

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

 

CAMBRIDGE, MA – April 2, 2019 – Aura Biosciences, a leader in the development of novel targeted therapies in ocular oncology, today announced that it closed a $40 million Series D financing. New investor Medicxi led the round, with current investors also participating.

The Company plans to use the proceeds from the Series D financing to support the late stage clinical development of their lead asset, light-activated AU-011, for the treatment of primary choroidal melanoma.

“The additional funding provided by this Series D financing enables Aura to continue to execute on our goals of developing the first targeted treatment for patients with primary choroidal melanoma, a life and vision threatening rare disease with no drugs approved,”

said Elisabet de los Pinos, Ph.D., Chief Executive Officer of Aura.

“We are delighted to have the support from lead investor Medicxi, along with our existing investors, as we enter this next stage of the company’s growth.”

In conjunction with the closing of the financing, Giovanni Mariggi, Ph.D., a Partner at Medicxi, will join Aura’s Board of Directors.

About Choroidal Melanoma

Choroidal melanoma is a rare and aggressive type of eye cancer. Choroidal melanoma is the most common primary intraocular tumor in adults and develops in the uveal tract of the eye. No targeted therapies are commercially available at present. The most common current treatment for choroidal melanoma is plaque radiotherapy, which involves surgical placement of a radiation device on the exterior of the eye over the tumor and is associated with severe visual loss and other long-term sequelae such as dry eye, glaucoma, cataracts and radiation retinopathy. The only other alternative is enucleation, or total surgical removal of the eye. Choroidal melanoma metastasizes in approximately 50 percent of cases with liver involvement in 80-90% of cases and, unfortunately, metastatic disease is universally fatal (source: OMF). There is a very high unmet need for a new vision-sparing targeted therapy that could enable early treatment intervention for this life-threatening rare disease given the lack of approved therapies, and the comorbidities of radioactive treatment options.

About Light-Activated AU-011

AU-011 is a first-in-class targeted therapy in development for the primary treatment of choroidal melanoma. The therapy consists of proprietary viral-like particle bioconjugates (VPB) that are activated with an ophthalmic laser. The VPBs 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. Upon activation with an ophthalmic laser, the VPB rapidly and specifically disrupts the cell membrane 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 radiation treatment. AU-011 can be delivered using equipment commonly found in an 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 the treatment of choroidal 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 primary choroidal melanoma, is being developed under a CRADA with the National Cancer Institute (NCI), part of the National Institutes of Health. Current institutional investors participating in the financing includes Advent Life Sciences, Arix Bioscience, Chiesi Ventures, Columbus Venture Partners, Lundbeck Ventures and Ysios Capital. For more information, visit www.aurabiosciences.com.

About Medicxi

Medicxi is a European venture capital firm with the mission to create and invest in companies along the full drug development continuum. Medicxi was established by the former Index Ventures life sciences team, which has been active for over 20 years, and invests in both early and late-stage assets with a product vision that can fulfill a clear unmet need. GSK, Johnson & Johnson, Novartis and Verily, an Alphabet company, have invested in Medicxi funds. Please see www.medicxi.com for more information.

Contacts:

Media:

David Rosen

Argot Partners

212.600.1902 | david.rosen@argotpartners.com

Investors:

Joseph Rayne

Argot Partners

617.340.6075 | joseph@argotpartners.com

Feb 22
Love0

Axonics® Granted Expanded CE Mark Label; First and Only Sacral Neuromodulation System Approved for Use with Full-Body MRI Scans

By Axonics, Press Release
Press Release.

 

IRVINE, Calif.–(BUSINESS WIRE)–Feb. 22, 2019– Axonics Modulation Technologies, Inc. (NASDAQ: AXNX), a medical technology company focused on the development and commercialization of novel implantable Sacral Neuromodulation (“SNM”) devices for the treatment of urinary and bowel dysfunction, announced today that it has received CE mark approval for 1.5T and 3T full-body magnetic resonance imaging (“MRI”) conditional labeling for the Axonics r-SNM® System.

The Axonics r-SNM System is the only implantable SNM system that has received full-body MRI conditional labeling for sale in Europe1.

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

“Without this labeling, any patient requiring an MRI scan on any body part below the head must have their neurostimulator surgically explanted prior to the MRI scan, resulting in an additional surgery for the patient and additional costs to patients and the healthcare system. This authorization of full-body MRI scans in Europe is another important milestone for Axonics, differentiating our technology from the competitive system and further demonstrating the foresight of our engineers and our commitment to invest the time and capital to provide the best possible SNM solution for patients, clinicians and the healthcare system. As announced on February 12, Axonics submitted complete test data to the U.S. FDA for the purpose of gaining Conditional Full Body Magnetic Resonance Imaging labeling approval in the U.S.”

Full-body MRI labeling is a significant addition to the many differentiating attributes already offered by the Axonics r-SNM product: a miniaturized and long-lived implantable neurostimulator that is one-third the size of the only competitor and is qualified to last at least 15 years in the body. The Axonics r-SNM System also features, among other things, a fast and safe charging capability with an infrequent charging interval, and a patient-friendly wireless remote control.

“This is a game changer,”

said Karen L. Noblett, M.D., Chief Medical Officer of Axonics.

“Full-body MRI labeling is critical to patients who need, or may anticipate needing, magnetic resonance imaging. This new expanded labeling eliminates a major concern for both groups of patients and will allow more patients to choose SNM to treat their urinary and bowel dysfunction without compromising their quality of life.”

What is MRI Conditional Labeling
MRI is short for Magnetic Resonance Imaging. MR scanners come in different magnet field strengths measured in Tesla or “T”, usually between 0.5T and 3.0T. They also come in varying sizes including open and wide-bore. Simplistically, an MR scanner is a very large, strong magnet into which a patient lies. A radio wave is used to send signals to the body of the patient. The returning signals are received and converted into images by a computer attached to the MR scanner. The image quality of an MRI depends on signal and field strength. MRI Conditional Labeling means a product has been tested and demonstrated to pose no known hazards to the patient in a specified MRI environment with specified conditions of use and the results of testing are sufficient to characterize the behavior of the product in the MRI environment. Testing for devices that may be placed in the MRI environment should address magnetically induced displacement force and torque, unintended stimulation, and thermal injury. Other possible safety issues include but are not limited to, image artifact, device vibration, interaction among devices, the safe functioning of the device and the safe operation of the MRI system. Any parameter that affects the safety of the device should be listed and any condition that is known to produce an unsafe consequence must be described.

About Overactive Bladder and Sacral Neuromodulation
Overactive bladder (OAB) includes urinary urge incontinence and urinary frequency and affects an estimated 85 million adults in the U.S. and Europe. OAB is caused by a miscommunication between the bladder and the brain and significantly impacts quality of life. SNM therapy is a well-established treatment that has been widely employed to reduce symptoms and restore bladder function and is also employed to treat urinary retention and fecal incontinence. Reimbursement for SNM is well established in the United States and is a covered service in Europe, Canada and Australia.

About Axonics Modulation Technologies, Inc.
Axonics, based in Irvine, CA, is focused on development and commercialization of a novel implantable SNM system for patients with urinary and bowel dysfunction. The Axonics r-SNM System is the first rechargeable Sacral Neuromodulation system approved for sale in Europe, Canada and Australia. The r-SNM System offers a temporary disposable external trial system, a miniaturized and rechargeable long-lived stimulator that is qualified to function for at least 15 years. Also included is a tined lead, as well as patient-friendly accessories such as a charging system optimized for minimal charge time without overheating, a small, easy to use patient remote control and an intuitive clinician programmer that facilitates lead placement and programming. For more information, visit the Company’s website at www.axonicsmodulation.com.

Forward-Looking Statements
Statements made in this press release that relate to future plans, events, prospects or performance are forward-looking statements as defined under the Private Securities Litigation Reform Act of 1995. Words such as “planned,” “expects,” “believes,” “anticipates,” “designed,” and similar words are intended to identify forward-looking statements. While these forward-looking statements are based on the current expectations and beliefs of management, such forward-looking statements are subject to a number of risks, uncertainties, assumptions and other factors that could cause actual results to differ materially from the expectations expressed in this press release, including the risks and uncertainties disclosed in Axonics filings with the Securities and Exchange Commission, all of which are available online at www.sec.gov. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Except as required by law, Axonics undertakes no obligation to update or revise any forward-looking statements to reflect new information, changed circumstances or unanticipated events.

1 The Axonics r-SNM System is approved for sale in Europe, Canada and Australia. It currently is designated as an investigational medical device in the U.S.

View source version on businesswire.com: https://www.businesswire.com/news/home/20190222005367/en/

Source: Axonics Modulation Technologies, Inc.

Axonics’ Contact
Axonics Modulation Technologies, Inc.
Dan Dearen, +1-949-396-6320
President & Chief Financial Officer
ir@axonics.com

Investor & Media Contact
W2Opure
Matt Clawson, +1-949-370-8500
mclawson@w2ogroup.com

Oct 31
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Axonics Modulation Technologies, Inc. Announces Pricing of Initial Public Offering of Common Stock

By Axonics, Press Release
Press Release.

 

October 31, 2018

IRVINE, Calif.–(BUSINESS WIRE)–Oct. 30, 2018– Axonics Modulation Technologies, Inc. (“Axonics”), a medical technology company focused on the design, development and commercialization of innovative and minimally invasive sacral neuromodulation (“SNM”) solutions for the treatment of overactive bladder (“OAB”), fecal incontinence (“FI”), and urinary retention (“UR”), today announced the pricing of its initial public offering of
8,000,000 shares of common stock at an initial public offering price of $15.00 per share, before underwriting discounts and commissions. Axonics has also granted the underwriters a 30-day option to purchase an additional 1,200,000 shares of common stock at the initial public offering price, less underwriting discounts and commissions. All of the shares of common stock are being offered by Axonics.

The shares of Axonics’ common stock have been approved for listing on The Nasdaq Global Select Market and are expected to begin trading under the ticker symbol “AXNX” on October 31, 2018. The offering is expected to close on November 2, 2018, subject to customary closing conditions.

BofA Merrill Lynch and Morgan Stanley are acting as joint book-running managers for the offering. Wells Fargo Securities is acting as lead manager and SunTrust Robinson Humphrey is acting as co-manager for the offering.

A registration statement on Form S-1, including a prospectus, which is preliminary and subject to completion, relating to the offering has been filed with, and declared effective by, the U.S. Securities and Exchange Commission on October 30, 2018. The offering of these shares is being made only by means of a prospectus. Copies of the prospectus may be obtained from BofA Merrill Lynch, NC1-004-03-43, 200 North College Street, 3rd Floor, Charlotte, NC 28255-0001, Attention: Prospectus Department, or by email at dg.prospectus_requests@baml.com; or Morgan Stanley & Co. LLC, Attention: Prospectus Department, 180 Varick Street, 2nd Floor, New York, NY 10014.

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 orjurisdiction.

About Axonics Modulation Technologies, Inc.

Axonics has developed an innovative rechargeable SNM system for the treatment of patients with OAB, FI, and UR. Axonics’ proprietary r-SNM System is designed to be 60% smaller than existing technology and to last approximately 15 years. Axonics currently has marketing approvals in Europe, Canada, and Australia for OAB, FI, and UR.

Forward-Looking Statements

This press release contains certain forward-looking statements, including statements with regard to Axonics’ proposed initial public offering. Wordssuch as “expects,” “anticipates” and “intends” or similar expressions are intended to identify forward-looking statements. These forward-lookingstatements are subject to the inherent uncertainties in predicting future results and conditions and no assurance can be given that the proposed initial
public offering discussed above will be completed on the terms described. Completion of the proposed initial publicoffering and the terms thereof aresubject to numerous factors, many of which are beyond the control of Axonics, including, without limitation, failure of customary closing conditions andthe risk factors and other matters set forth in the prospectus included in the registration statement in the form last filed with the U.S. Securities and Exchange Commission. Axonics undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as may be required by law.

View source version on businesswire.com: https://www.businesswire.com/news/home/20181030006223/en/

Source: Axonics Modulation Technologies, Inc.

Axonics’ Contacts
Axonics Modulation Technologies, Inc.
Dan Dearen, +1-949-396-6320
President & Chief Financial Officer
ddearen@axonicsmodulation.com
or
Investor & Media Contact
W2Opure
Matt Clawson, +1-949-370-8500
mclawson@w2ogroup.com

Oct 15
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Aravive Biologics and Versartis Complete Merger

By Aravive, Press Release, Publicly Listed
Press Release.

 

October 15, 2018

The combined company, Aravive, Inc., to trade on Nasdaq under ticker symbol “ARAV” beginning October 16, 2018, concurrent with a 1-for-6 reversesplit of common shares

HOUSTON, Oct. 15, 2018 (GLOBE NEWSWIRE) — Aravive Biologics, Inc. and Versartis, Inc. (Nasdaq:VSAR) announced that the merger of the two companies has closed following Versartis stockholder approval on October 5, 2018. Beginning tomorrow, October 16, 2018, the combined company will operate as Aravive, Inc. and its shares will trade on the Nasdaq Global Select Market under the new ticker symbol “ARAV”. Aravive, Inc. is a clinical stage biotechnology company focusing on developing innovative therapies that target important survival pathways for cancer.

Concurrent with the close of the merger, the combined company, Aravive, Inc., announced a 1-for-6 reverse split of its common shares. The reverse split will be effective upon opening of trading tomorrow, October 16, 2018. When the reverse split becomes effective, every 6 shares of issued and
outstanding “ARAV” common stock will be combined into 1 issued and outstanding share of common stock with no changes to the par value of the shares. The reverse split will reduce the number of shares of Aravive’s outstanding common stock from approximately 67.1 million to approximately
11.2 million.

“We are excited to launch Aravive, Inc. as a newly merged, public company with a promising development program that has the potential to bring innovative cancer therapies to patients in need,”

said Jay Shepard, president and chief executive officer.

“Our initial focus is on the development of a first-in-class, GAS6 binding protein designed to prevent AXL signaling, a pathway known to play a role in tumor metastasis and treatment resistance. Aravive completed the first Phase 1 clinical trial of our lead candidate, AVB-S6-500, and we expect to initiate the Phase 1b portion of our Phase 1b/2 trial in patients with platinum resistant ovarian cancer before the end of the year. Based on compelling results from our non-clinical studies, we also plan to evaluate AVB-S6-500 in additional tumor types and, longer term, its potential for treating fibrosis.”

Unaudited pro forma cash and cash equivalents for the combined company as of the close of the merger is expected to be in the range of $60.0 million to $62.0 million, net of all estimated transaction costs. Following the completion of the merger, the board of directors of the combined company will include Srinivas Akkaraju, M.D., Ph.D., chairman; Jay Shepard, president and chief executive officer; Shahzad Malik, M.D; Amato Giaccia, Ph.D., scientific founder of Aravive Biologics; Ray Tabibiazar, M.D., founder and former executive chairman of Aravive Biologics; and Eric Zhang, CFA. In addition, concurrent with the close of the merger, the board of directors has appointed an additional independent director, Robert E. Hoffman. Mr. Hoffman is currently chief financial officer and senior vice president, finance of Heron Therapeutics.

About Aravive

Aravive, Inc. (Nasdaq: ARAV effective October 16, 2018) is a clinical stage biotechnology company focused on developing innovative therapies that target important survival pathways for cancer. Aravive’s lead candidate, AVB-S6-500, is a novel, high-affinity, soluble Fc-fusion protein designed to block the activation of the GAS6-AXL signaling pathway by intercepting the binding of GAS6 to its receptor AXL. AXL receptor signaling plays an important role in multiple types of malignancies by promoting metastasis, cancer cell survival, resistance to treatments, and immune suppression. Aravive expects to initiate the Phase 1b portion of a Phase 1b/2 clinical trial of AVB-S6-500 combined with standard of care therapies in patients with platinum-resistant ovarian cancer before the end of 2018, and intends to expand development into additional tumor types. For more information, please visit www.aravive.com.

Forward Looking Statements

This communication contains forward-looking statements (including within the meaning of Section 21E of the United States Securities Exchange Act of 1934, as amended, and Section 27A of the United States Securities Act of 1933, as amended) concerning the Company’s potential to bring innovative cancer therapies to patients in need, the expected timing of initiation of the Phase 1b portion of the Company’s Phase 1b/2 trial in patients with platinum resistant ovarian cancer and the plan to evaluate and expand the development of AVB-S6-500 in additional tumor types and, longer term, its potential for treating fibrosis. Forward-looking statements are based on current beliefs and assumptions that are subject to risks and uncertainties and are not guarantees of future performance. Actual results could differ materially from those contained in any forward-looking statement as a result of various factors. The foregoing review of important factors that could cause actual events to differ from expectations should not be construed as exhaustive and should be read in conjunction with statements that are included herein and elsewhere, including the risk factors included in the Company’s proxy statement/prospectus/information statement filed with the SEC on September 6, 2018, the Company’s Form S-4 filed with the SEC on August 3, 2018, as subsequently amended, Annual Report on Form 10-K and Form 10-K/A for the fiscal year ended December 31, 2017, Quarterly Report on Form 10-Q for the quarter ended June 30, 2018, and recent Current Reports on Form 8-K, each as filed with or furnished to the SEC. Except as required by applicable law, the Company undertakes no obligation to revise or update any forward-looking statement, or to make any other forward-looking statements, whether as a result of new information, future events or otherwise.

Contacts:
Investors:
Mike Zanoni
Endurance Advisors
mzanoni@enduranceadvisors.com
610-442-8570

Media:
Christine Labaree
Evergreen Communications
christine@evergreencomms.com

Aug 29
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KaNDy Therapeutics successfully raises £25 million in a Series C financing

By KaNDy Therapeutics, Press Release
Press Release.

 

Funding to advance a breakthrough non-hormonal treatment for symptoms of the menopause, into a Phase 2b study in Q4 2018

Stevenage, UK, 29 August 2018 – KaNDy Therapeutics, a clinical-stage Women’s Health company, today announces it has successfully closed a Series C financing round, raising £25 million from new US investor Longitude Capital, and existing internationally recognised life sciences investors Advent Life Sciences, Fountain Healthcare Partners, Forbion Capital Partners and OrbiMed.

The proceeds will enable KaNDy Therapeutics to advance its breakthrough non-hormonal drug candidate, NT-814, for treatment of multiple symptoms of the menopause, through a multi-country Phase 2b dose-ranging study due to start recruiting patients in Q4 2018 with headline results expected in late 2019.

Commenting on the financing round, Mary Kerr CEO of KaNDy Therapeutics, said:

“We are delighted by the level of enthusiasm and financial support we have received from our investors and would like to welcome Longitude Capital into the syndicate and the board of directors. Our investors and the KaNDy management team are united by the common belief that NT-814 has the potential to be a transformational treatment for the millions of women worldwide who suffer debilitating symptoms of the menopause.”

NT-814 is an orally administered once daily, potent and selective small molecule dual antagonist of both the neurokinin-1 and 3 receptors. It is being developed by KaNDy Therapeutics to provide a viable alternative to hormone replacement therapy. In June 2018, the Company announced positive data from the Phase Ib/IIa proof of concept clinical trial which showed that women who were treated with NT-814 once daily for two weeks at the most effective doses evaluated, experienced a rapid and profound reduction in two key symptoms of the menopause, namely frequency and severity of hot flashes and the number of night time awakenings

Josh Richardson, M.D., Managing Director of Longitude Capital said:

“We were very pleased to participate in this funding round.  We have been impressed with the data announced thus far, by KaNDy’s business strategy and the strong and experienced management team.  We believe NT-814 has the potential to greatly improve the quality of life of millions of women worldwide and we look forward to supporting the Company as it continues to progress this potentially transformational   candidate through the clinic towards commercialization.”

A Phase 2b study to further evaluate the safety and efficacy of NT-814 in women with bothersome post-menopausal symptoms, and to establish the optimum dose to take forward into Phase 3, is anticipated to start recruiting patients in the US, Canada and the UK in Q4 2018, with headline results expected in late 2019.

For more information, please contact:

KaNDy Therapeutics
Mary Kerr, Managing Director of KaNDy Therapeutics
Tel: +44 1438 906960
Email: info@kandytherapeutics.com

Consilium Strategic Communications
Mary-Jane Elliott/ Lindsey Neville/ Carina Jurs
Tel: +44 (0) 20 3709 5700
KaNDyTherapeutics@consilium-comms.com

About KaNDy Therapeutics
KaNDy Therapeutics is a clinical-stage company focused on optimizing the potential of NT-814 as a non-hormonal treatment for common, chronic debilitating female sex-hormone related conditions. These conditions, such as post-menopausal hot flashes, can impact womens’ quality of life for 10 years or more and are associated with significant social, healthcare and economic costs.

NT-814 is a once-a-day oral, potent and selective small molecule dual antagonist of both the neurokinin-1 and 3 receptors under development by KaNDy as a therapy for a range of Women’s Health conditions. NT-814 addresses hot flashes by modulating a group of oestrogen sensitive neurones in the hypothalamus in the brain (the KNDy neurones), that in menopausal women due to the absence of oestrogen, become hyperactive and consequently disrupt body heat control mechanisms resulting in the debilitating vasomotor symptoms of HF.

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 include Algeta, Avila, CardiAQ, CN Creative, EUSA and Micromet. Current investments include Acutus, Arrakis, Aura, Axonics, GMPO and NeRRe. For more information, please visit www.adventls.com.

About Forbion Capital Partners
Forbion is a dedicated life sciences venture capital firm with offices in The Netherlands and Germany. Forbion invests in life sciences companies that are active 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 over 50 companies. Forbion manages well over EUR 1 billion across ten funds. 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 BGV, the manager of seed and early stage funds focused on Benelux and Germany. www.forbion.com

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. For more information, please visit www.fh-partners.com.

About Longitude Capital
Longitude Capital is a private investment firm that makes venture growth investments in biotechnology and medical technology companies that seek to improve clinical outcomes, enhance quality of life and/or reduce system costs. Longitude Capital invests in both privately held and publicly traded life science companies through a variety of investment approaches. Since 2006, Longitude Capital has raised over $1.2 billion across three funds and has offices in Menlo Park, CA and Greenwich, CT. For more information, please visit www.longitudecapital.com.

About OrbiMed
OrbiMed is a leading healthcare investment firm, with $14 billion in assets under management. OrbiMed invests globally across the healthcare industry, from start-ups to large multinational corporations, utilizing a range of private equity funds, public equity funds, and royalty/credit funds. OrbiMed maintains offices in New York City, San Francisco, Shanghai, Hong Kong, Mumbai and Herzliya. OrbiMed seeks to be a capital provider of choice, providing tailored financing solutions and global team resources and support to help build world-class healthcare companies.