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Feb 22
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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
Love0

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.

May 24
Love0

Iterum Therapeutics Announces Pricing of Initial Public Offering

By Iterum, Press Release, Publicly Listed
Press Release.

 

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

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

A registration statement relating to these securities has been filed with, and declared
effective by, the SEC. This press release shall not constitute an offer to sell or the
solicitation of an offer to buy, nor shall there be any sale of these securities in any state or
jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or
qualification under the securities laws of any such state or jurisdiction.

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

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

SOURCE Iterum Therapeutics

Dec 21
Love0

Aura Biosciences Completes $30 Million Series C Financing

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

 

December 21, 2017

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

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

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

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

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

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

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

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

said Casper Breum, Senior Partner at Lundbeckfonden Ventures.

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

said Mark Chin, Investment Director at Arix Bioscience.

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

About ocular melanoma

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

About light-activated AU-011

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

About Aura Biosciences

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

About Lundbeckfonden

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

About Arix Bioscience plc

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

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

For further information, please visit www.arixbioscience.com.

About Advent Life Sciences

Advent Life Sciences is one of Europe’s leading venture teams investing in life sciences businesses. The team consists of professionals with extensive scientific, medical and operational experience, and a long-standing track record of entrepreneurial and investment success across the UK, Europe and the US. The firm invests in a range of sectors within life sciences, principally in new drug discovery, enabling technologies and med tech. Realizations in the last three years include Algeta, Avila, CN Creative, EUSA and Micromet. Current investments include Acutus, Biocartis, Cellnovo, f2G, NeRRe, and Versartis. For more information, please visit www.adventls.com.

About Chiesi Ventures

Chiesi Ventures is a venture capital firm focused on the area of rare and orphan disorders. Our goal is to complement the strategic interest of the Chiesi Group by investing in early stage development opportunities. Chiesi Ventures also aim to accelerate the expansion of the Chiesi network in the US among universities, venture capital investors, rare disease patient organizations and entrepreneurial companies developing treatments for rare diseases. For more information, please visit www.chiesiventures.com.

About Ysios Capital

Ysios Capital is a leading Spanish venture capital firm that provides private equity financing to early- and mid-stage human healthcare and life science companies with a special focus on pharmaceuticals, diagnostics and medical devices. Founded in 2008, Ysios Capital has €118 million in assets under management distributed over two funds. The second fund has a target size of €100 million and will remain open to new investors until September 2015. For further information see www.ysioscapital.com.

About Alexandria Venture Investments

Alexandria Venture Investments is the strategic venture capital arm of Alexandria Real Estate Equities, Inc. (NYSE: ARE). Founded in 1994, Alexandria is the largest and leading investment-grade real estate investment trust (REIT) focused principally on owning, operating, and developing high-quality, sustainable real estate for the broad and diverse life science and technology industries. In 1996, Alexandria founded Alexandria Venture Investments to actively invest at the cutting edge of novel, breakthrough discoveries in biopharmaceuticals, diagnostics, research tools, medical devices, digital health, and technology. Alexandria is uniquely positioned to fund life science and advanced technology companies based on its experience and in-depth understanding of these industries, its long-term relationships with leading investors, and its world-class international scientific advisory network. For more information, please visit www.are.com.

About LI-COR Biosciences

LI-COR Biosciences is a leading manufacturer of near-infrared and chemiluminescence imaging platforms, analysis software, and IRDye® infrared dye reagents for drug discovery, life science research, and pre-clinical imaging. Founded in 1971, the privately held company is based in Lincoln, Nebraska.

Media Contact

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

Oct 24
Love0

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

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

 

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Sep 27
Love0

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

By F2G, Press Release, Private Companies
Press Release.

 

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

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

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

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

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

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

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

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

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

–ENDS–

 

For further information, please contact:

Mary Kerr, Managing Director of KaNDy Therapeutics

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

Notes for editors

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

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

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

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

Sep 27
Love0

NeRRe Therapeutics appoints Andrew Kay as Chairman of the Board

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

 

Extensive development & commercial expertise to guide company growth

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

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

Dr Mary Kerr, CEO of NeRRe Therapeutics, said,

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

Andrew Kay, Chairman of NeRRe Therapeutics, said,

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

–ENDS–

A photograph of Andrew Kay is available on request

Notes to Editors

About NeRRe Therapeutics (www.nerretherapeutics.com)

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

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

For more information, please contact:

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

Sep 27
Love0

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

By KaNDy Therapeutics, Press Release
Press Release.

 

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

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

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

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

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

Iain Dukes, Chairman of KaNDy Therapeutics, said,

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

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

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

–ENDS–

 

For further information, please contact:

Mary Kerr, Managing Director of KaNDy Therapeutics

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

Notes for editors

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

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

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

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