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May 24
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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

May 19
Love0

Iterum Secures $65 Million in Series B Financing

By Iterum, Press Release, Publicly Listed
Press Release.

 

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

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

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

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

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

said Corey Fishman, CEO of Iterum.

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

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

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

said Chin, investment manager at Arix Bioscience.

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

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

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

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

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

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

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

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

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

Media Contact:

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

Sep 29
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Aura Biosciences Secures $8 Million in Additional Funding

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

 

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

September 29, 2016

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

CAMBRIDGE, Mass.–(BUSINESS WIRE)–Aura Biosciences, a biotechnology company developing a new class of therapies to target and selectively destroy cancer cells using viral nanoparticle conjugates, announced today that it secured an additional $8 million round of funding. The company also announced the addition of Henri Termeer, former CEO of Genzyme and major Aura investor, to its Board of Directors, and welcomed key new Clinical Advisory Board (CAB) members, all distinguished ocular oncologists.

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

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

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

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

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

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

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

About Aura Biosciences

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

Media Contact

Ann Stanesa, 617-230-0347

Ten Bridge Communications

ann@tenbridgecommunications.com  

Mar 22
Love0

Acutus Medical Completes $75 Million Series C Financing

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

 

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

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

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

said Steve Hochberg, partner at Deerfield.

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

 

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

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

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

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

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

About Acutus Medical

Acutus Medical is a global heart rhythm technology company transforming the way electrophysiologists (EPs) diagnose and treat cardiac arrhythmias. The company is currently pursuing CE mark approval in Europe for the full suite of AcQMap™ System products. Acutus Medical is a privately held company located in Carlsbad, CA. To learn more, visit http://www.acutusmedical.com.

Forward Looking Statements

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

 

 

Media Contact

 

Julia Baron

Pure Communications, Inc.

(858) 692-2001

Julia@purecommunicationsinc.com

 

Investor Contact

 

Matt Clawson

Pure Communications, Inc.

(949) 370-8500

Matt@purecommunicationsinc.com

Mar 05
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Aura Biosciences Closes $21M Series B Financing

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

 

Prepares to enter clinical trials for the treatment of rare ocular cancers

CAMBRIDGE, MASSACHUSETTS – March 5, 2015 – Aura Biosciences, a biotech company developing highly tumor-targeted breakthrough therapies for rare cancers, has secured a $21M Series B round of funding.  The financing was led by Advent Life Sciences, with participation from new investors, Chiesi Ventures, Ysios Capital, and Alexandria Venture Investments.  Existing investors, including LI-COR Biosciences and Henri Termeer, former Chief Executive Officer of Genzyme, also participated in the financing.   The financing will be used to advance Aura’s unique and novel therapies into clinical trials for the treatment of rare cancers of the eye, and to further develop for additional cancer indications its first-in-class technology that was discovered and developed in partnership with Dr. John Schiller at the National Cancer Institute (NCI).

“Our investors share our vision and our conviction that our technology will uniquely enable the development of breakthrough therapies for orphan cancers that have no effective treatments,”

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

“Our lead product is focused on treating ocular cancers that are life-threatening, yet for which patients have no targeted or FDA-approved therapies available.  We are dedicated to bringing to this patient population first-in-class therapies that can both eliminate the tumor and preserve vision.”

Aura Biosciences’ platform is based on viral nanoparticles, a new class of drugs that harness the potential of a unique cell targeting for the treatment of cancer.  The technology was discovered and developed in partnership with Dr. John Schiller’s lab at the National Cancer Institute (NCI). Dr. Schiller is the recipient of the National Medal of Technology and Innovation by President Obama, the nation’s highest honor for technological achievement.

The nanoparticles demonstrate highly selective targeting of solid tumors and metastases while leaving normal epithelium untouched.  Aura’s lead product incorporates a viral nanoparticle conjugated with a potent cell-killing laser-activated molecule (IRDye 700DX, LI-COR Biosciences) that is delivered efficiently and selectively to cancerous cells, thereby reducing or eliminating the risk of non-specific activity and/or undesirable toxicity.  Aura Biosciences and the NCI have generated a considerable body of data in vitro and in vivo that shows highly selective tumor uptake in multiple animal models and provides a strong preclinical validation of the technology platform.

“Aura Biosciences is developing first-in-class drugs for rare ocular cancers that can improve patient outcomes and positively impact patient lives,”

said Dale Pfost, general partner at Advent Life Sciences.

“The data generated from Aura’s platform suggests that there is great potential to treat ocular cancers in a completely novel way with high tumor specificity along with maximal drug and laser penetration that can eliminate tumors with no damage to other ocular structures.”

“There is a tremendous unmet need for therapies that can help those with rare diseases,”

said Henri Termeer, former Chief Executive Officer of Genzyme, a pioneer in drug development for orphan indications.

“With Aura’s technology, once the product is confirmed in the clinic, patients with rare ocular cancers will have for the first time and in the near future a non-invasive targeted therapy available to them.”

In conjunction with the financing, Dale Pfost, General Partner at Advent Life Sciences, Art Pappas, CEO of A.M. Pappas & Associates, and Joël Jean-Mairet, Managing Partner at Ysios Capital will join Aura’s Board of Directors.  Current Board member Alan Walts, former head of Genzyme Ventures, will become Executive Chairman.  In addition, Alison Lawton, former Genzyme executive and former COO of OvaScience, will be appointed as Chief Operating Officer.

About Aura Biosciences
Aura Biosciences is applying nanotechnology to the fight against cancer.  Its novel viral nanoparticle technology, developed in partnership with the National Cancer Institute (NCI), harnesses the potential of viral evolution and tumor targeting for the treatment of cancer.  For more information, visit www.aurabiosciences.com.

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

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

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

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

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

Contact:

Matt Burke
+1 603.315.0618
mburke@aurabiosciences.com

Feb 05
Love0

Agenus Prices Public Offering of Common Stock

By Agenus, Press Release, Publicly Listed
Press Release.

 

Lexington, MA (February 5, 2014): Agenus Inc. (Nasdaq: AGEN) today announced the pricing
of an underwritten public offering of 19,335,653 primary shares of its common stock at a price of
$2.70 per share. Agenus has granted the underwriters a 30-day option to purchase up to
2,900,347 additional shares of common stock to cover over-allotments, if any.

William Blair & Company, L.L.C. is acting as sole book-running manager for the
offering. Maxim Group LLC is acting as lead manager and H.C. Wainwright & Co., LLC and
MLV & Co. LLC are acting as co-managers for the offering. Geller Biopharm Inc. is acting as
financial advisor for the offering.

The shares will be issued by Agenus pursuant to a shelf registration statement that was
previously filed with, and declared effective by, the Securities and Exchange Commission
(SEC). A preliminary prospectus supplement related to the offering has been filed with the SEC
and is available on the SEC’s website located at www.sec.gov. A final prospectus supplement
related to the offering will be filed with the SEC.

This press release does not constitute an offer to sell or a solicitation of an offer to buy
nor shall there be any sale of these securities in any state or jurisdiction in which such offer,
solicitation or sale would be unlawful prior to registration or qualification under the securities
laws of any such state or jurisdiction. Any offer, if at all, will be made only by means of a
prospectus supplement and accompanying prospectus forming a part of the effective registration
statement, copies of which may be obtained, when available, from William Blair & Company,
L.L.C., Attention: Prospectus Department, 222 West Adams Street, Chicago, IL 60606, by
telephone at (800) 621-0687, or by e-mail at prospectus@williamblair.com.

About Agenus

Agenus Inc. is a biotechnology company working to develop treatments for cancers and
infectious diseases. The company is focused on immunotherapeutic products based on strong
platform technologies with multiple product candidates advancing through the clinic, including
several product candidates that have advanced into late-stage clinical trials through corporate
partners. Between Agenus and its partners, 23 programs are in clinical development.

Additional Information

Statements made in this press release include forward-looking statements within the
meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the
Securities Exchange Act of 1934, as amended, regarding, but not limited to, the use of proceeds
from the offering. Forward-looking statements can be identified by the use of words such as
“may,” “will,” “plan,” “should,” “expect,” “anticipate,” “estimate,” “continue,” or comparable
terminology. Such forward-looking statements are inherently subject to certain risks, trends and
uncertainties, many of which Agenus cannot predict with accuracy and some of which Agenus
might not even anticipate, and involve factors that may cause actual results to differ materially
from those projected or suggested. These risks and uncertainties include, among others, the
factors described under the Risk Factors section of Agenus’ Current Report on Form 8-K, which
was filed with the SEC on February 4, 2014. Agenus cautions investors not to place considerable
reliance on the forward-looking statements contained in this release. These statements speak only
as of the date of this press release, and Agenus undertakes no obligation to update or revise the
statements.

Media and Investor Contact:
Jonae R. Barnes
Vice President
Investor Relations and
Corporate Communications
jonae.barnes@agenusbio.com
617-818-2985

Jan 13
Love0

Agenus Enters into Definitive Agreement to Acquire Privately Held 4-Antibody AG

By Agenus, Press Release, Publicly Listed
Press Release.

 

  • 4-Antibody has a powerful platform for rapid discovery and optimization of fully-human antibodies against a wide array of  molecular targets
  • Lead programs target six immune checkpoint molecules
  • Checkpoint antibodies have produced unprecedented results against a variety of cancers affecting a large number of patients
  • Collaborations with the Ludwig Institute for Cancer Research and Memorial Sloan-Kettering Cancer Center

Lexington, MA – January 13, 2014

Agenus Inc. (Nasdaq: AGEN) a biotechnology company developing novel immune system activating treatments for cancers and infectious diseases, today announced that it has entered into a definitive agreement to acquire 4-Antibody AG, a private European-based biopharmaceutical company. 4-Antibody has a technology platform for the rapid discovery and optimization of fully-human antibodies against a wide array of molecular targets of interest. These targets include checkpoint molecules that regulate immune response to cancers and other diseases. The company has multiple preclinical immune checkpoint antibody programs targeting numerous checkpoint molecules, including GITR and OX40, as well as four additional undisclosed checkpoint programs. These checkpoint programs are being pursued through a strategic collaboration with the Ludwig Institute for Cancer Research and Memorial Sloan-Kettering Cancer Center (MSKCC) in New York.

Checkpoint-targeting antibodies have produced unprecedented clinical results in various cancers, such as melanoma, renal cell carcinoma and non-small cell lung cancer (NSCLC). There is also a growing interest in combining checkpoint-targeting antibodies with other immune stimulating agents.

Under the terms of the agreement, Agenus has agreed to acquire all of the outstanding stock of 4-Antibody for an initial payment of $10 million in shares of Agenus common stock, plus additional contingent payments, payable in cash or Agenus common stock, that may exceed $40 million based on the combined company achieving certain milestones. The transaction is expected to be completed by the end of February 2014, subject to customary closing conditions.

Agenus intends to maintain 4-Antibody’s current operations in Basel, Switzerland and Jena, Germany, and to retain the 4-Antibody management team as part of the combined company. In addition, Shahzad Malik, M.D., General Partner at Advent Venture Partners, 4-Antibody’s largest investor, will be appointed to Agenus’ Board of Directors upon the closing.

“This acquisition will initially provide Agenus with two leading edge checkpoint antibody programs targeting GITR and OX40 as well as programs targeting numerous additional checkpoint molecules,”

said Garo Armen, Ph.D., CEO and chairman of Agenus.

“With these assets, we will be uniquely positioned to pursue cancer immunotherapy with a broad portfolio of innovative approaches. Furthermore, we will gain a flexible platform for rapid discovery and optimization of fully-human antibodies against a wide array of molecular targets of interest.”

4-Antibody is in collaboration with leading institutions such as the Ludwig Institute for Cancer Research and MSKCC, and corporate collaborations include Brazil based Recepta Biopharma. The company is in discussions for additional potential corporate partnerships.

“The translational expertise of the Ludwig Institute and MSKCC, coupled with 4-Antibody’s powerful antibody discovery platform, has allowed us to generate a robust product pipeline of programs in the fast moving immune checkpoint field. Agenus’ extensive experience in pre-clinical and clinical development of immunotherapies provides a unique combination of resources for the speedy development of these programs,”

said Robert Burns, Ph.D, CEO of 4-Antibody.

About Checkpoint Antibodies
Considerable recent interest in the field of cancer immunotherapy has been generated by promising clinical data with monoclonal antibodies that bind to checkpoint molecules, such as cytotoxic T lymphocyte antigen-4 (CTLA-4) and programmed death receptor-1 (PD-1). Blocking these checkpoint molecules unlocks the braking mechanism that gets in the way of immune cells attacking cancer cells.
Other checkpoint molecules, such as GITR and OX40, act to stimulate immune function. 4-Antibody has cutting edge programs to discover and develop fully human or humanized monoclonal antibodies that act as agonists for GITR or OX40 signaling.

About Agenus
Agenus Inc. is a biotechnology company developing treatments for cancers and infectious diseases. The company has multiple immunotherapeutic products in its clinical development portfolio. Through partnerships involving its QS-21 Stimulon adjuvant, there are 21 candidates in clinical development. These include four late stage Phase 3 programs with GlaxoSmithKline. For more information, please visit www.agenusbio.com, or connect with the company on Facebook, LinkedIn, Twitter and Google+.

About 4-Antibody AG
4-Antibody has developed a powerful fully-human antibody drug-discovery and optimization technology platform which it is utilizing to generate a novel pipeline of antibody therapeutic candidates. The company’s proprietary discovery engine Retrocyte Display® generates high quality therapeutic antibody drug candidates quickly using a high-throughput approach incorporating full-length IgG format human antibody libraries expressed in mammalian B-lineage cells. 4-Antibody is a private company located in Basel, Switzerland and Jena, Germany. For more information please visit: www.4-antibody.com

Forward-Looking Statement
This press release contains forward-looking statements, including without limitation, statements regarding the proposed acquisition of 4-Antibody, the potential effects that the acquisition of 4-Antibody may have on the business of the Company, and the ability of 4-Antibody platform to generate product candidates and their potential application in the prevention and treatment of diseases. These forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially. These risks and uncertainties include, among others, the factors described under the Risk Factors section of our Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission for the period ended September 30, 2013. Agenus cautions investors not to place considerable reliance on the forward-looking statements contained in this release. These statements speak only as of the date of this document, and Agenus undertakes no obligation to update or revise the statements. All forward-looking statements are expressly qualified in their entirety by this cautionary statement. Agenus’ business is subject to substantial risks and uncertainties, including those identified above. When evaluating Agenus’ business and securities, investors should give careful consideration to these risks and uncertainties.