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Apr 01
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Eloxx Pharmaceuticals Acquires Zikani Therapeutics

By Eloxx Pharmaceuticals, Press Release, Publicly Listed
Press Release.

 

Combined Company to be Leader in Ribosomal RNA-Targeted Genetic Therapy Bringing Together Complementary Platforms

Maximizes Potential for ELX-02 for Cystic Fibrosis in Phase 2 Development

Adds Preclinical Stage Pipeline in Rare Diseases and Oncology Targeting RNA
and Ribosomal Mutations

Expect to File IND for First Oral Drug to Treat Patients with Recessive Dystrophic
and Junctional Epidermolysis Bullosa (RDEB and JEB)

Sumit Aggarwal, Zikani President and CEO, to Lead the Combined Company

Eloxx to Issue Approximately 7.6 Million Shares to Zikani Stockholders

Company to Host Investor Call at 8:30 a.m. ET, April 1

WALTHAM, MA and WATERTOWN, MA – APRIL 1, 2021 – Eloxx Pharmaceuticals, Inc. (NASDAQ: ELOX) today announced it has acquired Zikani Therapeutics, Inc. in an all-stock transaction, with the potential to create a leader in ribosomal RNA-targeted therapies for treatment of rare diseases and oncology. Sumit Aggarwal, previously the President and Chief Executive Officer of Zikani, has been named President and Chief Executive Officer of Eloxx, and Vijay Modur, M.D., Ph.D., who was Zikani’s Chief Scientific and Medical Officer, has been named Eloxx’s Head of Research and Development.

“With the strength of our ELX-02 program for cystic fibrosis, this acquisition provides us with the opportunity to amplify the potential of our innovative science by developing a new class of therapies to treat diseases with limited to no treatment options under the stewardship of leaders with a proven ability to translate technology into treatments for patients,”

said Tomer Kariv, Eloxx Chairman.

“We are excited about the potential of ELX-02 and combining the companies opens the door to build a leadership position in genetic therapy by rapidly developing treatments that can restore functional proteins in patients with nonsense mutations in their RNA,”

said Aggarwal.

“The combined capabilities of Eloxx and Zikani in chemistry, biology, regulatory and drug development, including Zikani’s TURBO-ZMTM synthetic chemistry platform for designing macrolide-based Ribosome Modulating Agents (RMAs), along with a committed leadership team and talented employees, will further accelerate our ability to impact the lives of those who have rare diseases with the type of urgency and novel thinking that they deserve,”

added Aggarwal.

ELX-02 is currently in Phase 2 clinical trials in Cystic Fibrosis (CF) patients affected by nonsense mutations in the cystic fibrosis transmembrane conductance regulator (CFTR) gene. The investigational therapy has shown strong activity across a full range of mutations in CF preclinical models. In Phase 1 testing, ELX-02 was generally well- tolerated and demonstrated high bioavailability with consistent pharamacokinetics across both single and multiple-dose studies.

“The Phase 2 trials are designed to validate the safety of ELX-02 and assess its biological activity. We look forward to completing enrollment in the first four treatment arms by mid-year and reporting data from these treatment arms in the second half of this year,”

said Dr. Modur.

In addition to CF, the company plans to file an IND in 2022 for what could potentially become the first oral therapy for protein restoration for patients with nonsense mutations in Recessive Dystrophic Epidermolysis Bullosa (RDEB) and Junctional Epidermolysis Bullosa (JEB). RDEB is an incurable, extremely painful and often fatal skin blistering condition caused by a lack of collagen type VII that is estimated to affect more than 3,000 people worldwide. JEB is the most severe form of EB, with most patients dying in infancy.

By extending the application of ribosomal RNA modulation to the readthrough of nonsense mutations in tumor suppressor genes, the company is also rapidly advancing preclinical research for familial adenomatous polyposis (FAP), an inherited pre-cancerous colorectal disease frequently caused by nonsense mutations in the adenomatous polyposis coli (APC) gene.

Nonsense mutations cause approximately 10-12 percent of rare inherited diseases. ELX-02 along with the TURBO-ZMTM library of compounds are anticipated to significantly expand to include the treatment of many other rare diseases and certain cancers.

Acquisition Terms

Under the terms of the merger agreement, stockholders of Zikani received approximately 7.6 million Eloxx common shares and own approximately 16 percent of the combined company.

Board and Management Changes

In connection with the acquisition, Silvia Noiman, Ph.D., and Martijn Kleijwegt have stepped down from the Eloxx Board. Alan Walts, Ph.D., and Raj Parekh, Ph.D., who have both served as Zikani directors, were appointed to fulfill the vacancies and serve out the remaining terms of office.

“We’re pleased to welcome Sumit and Vijay to the Eloxx leadership team. They demonstrated their ability to transform Zikani by following the science and pursuing the creation of a new class of therapies on behalf of patients with unmet medical need. We want to extend our thanks and appreciation to Dr. Greg Williams for his stewardship of Eloxx and his commitment to advancing the critical work of the company. We are pleased that Greg will continue to advise Eloxx to facilitate a smooth transition” said Kariv.

Conference Call Information

Date: Thursday, April 1, 2021

Time: 8:30 a.m. ET

Domestic Dial-in Number: (866) 913-8546

International Dial-in Number: (210) 874-7715

Conference ID: 8180169

Live Webcast: accessible from the Company’s website at www.eloxxpharma.com under Events and Presentations or by clicking here. A replay of this conference call will be available on the Eloxx and Zikani websites.

Leadership Profiles

Sumit Aggarwal

Sumit Aggarwal served as Zikani’s President and CEO. He has led the transformation of Zikani from an early-stage technology company to a development-stage rare disease and oncology focused organization. Under Aggarwal’s leadership, Zikani has concentrated its focus on demonstrating pre-clinical proof of efficacy across several disease states using its TURBO-ZM™ technology platform.

In his more than 20 years in pharmaceutical and biotechnology commercial operations, investment management and management consulting, Aggarwal has been successful in transforming companies by re-invigorating innovation, growth and profitability, and raising capital for promising technology companies.

Prior to joining Zikani, he reinvigorated growth and profitability at Progenity, raised $125 million in capital and built a novel drug delivery-based GI pipeline. He also held leadership roles in healthcare and biotechnology at Adage Capital and as an Associate Partner at McKinsey & Company in its healthcare practice.

Aggarwal has an MBA with distinction from the Johnson School, Cornell University, and a Bachelor of Technology with Honors in Chemical Engineering from the Indian Institute of Technology, Kharagpur.

Vijay Modur, M.D., Ph.D.

Vijay Modur, M.D., Ph.D., served as Zikani’s Chief Scientific and Medical Officer and has led the scientific efforts to transform medicines based on ribosomal modulation using Zikani’s proprietary TURBO-ZM™ technology platform.

In his more than 20 years in pharmaceutical and diagnostic roles in R&D, he has successfully translated research discovery efforts into products that have impacted medical practice.

Prior to joining Zikani, Dr. Modur led the venglustat rare disease program at Sanofi across multiple rare disease indications into Phase 2 and Phase 3 clinical development along with leading other early development programs. Prior to Sanofi, he held leadership roles in HTG Molecular, Novartis Oncology and Merck Research Labs.

Dr. Modur obtained his MBBS from Karnatak University and his Ph.D. from the University of Utah. He was a resident in Clinical Pathology at Washington University School of Medicine where he also completed his post-doctoral fellowship.

About Eloxx Pharmaceuticals

Eloxx Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company developing novel RNA-modulating drug candidates (designed to be eukaryotic ribosomal selective glycosides) that are formulated to treat rare and ultra-rare premature stop codon diseases. Premature stop codons are point mutations that disrupt protein synthesis from messenger RNA. As a consequence, patients with premature stop codon diseases have reduced or eliminated protein production from the mutation bearing allele accounting for some of the most severe phenotypes in these genetic diseases. These premature stop codons have been identified in over 1,800 rare and ultra-rare diseases. Read-through therapeutic development is focused on extending mRNA half-life and increasing protein synthesis by enabling the cytoplasmic ribosome to read through premature stop codons to produce full-length proteins. Eloxx’s lead investigational product candidate, ELX-02, is a small molecule drug candidate designed to restore production of full-length functional proteins. ELX-02 is in the early stages of clinical development focusing on cystic fibrosis. ELX-02 is an investigational drug that has not been approved by any global regulatory body. Eloxx’s preclinical candidate pool consists of a library of novel drug candidates designed to be eukaryotic ribosomal selective glycosides identified based on readthrough potential. Eloxx also has preclinical programs focused on kidney diseases including autosomal dominant polycystic kidney disease, as well as rare ocular genetic disorders. Eloxx is headquartered in Waltham, MA, with operations in Rehovot, Israel, and Morristown, NJ. For more information, please visit www.eloxxpharma.com.

About Zikani Therapeutics

Zikani Therapeutics is an emerging leader in the science of ribosome modulation, leveraging its innovative TURBO-ZMTM chemistry technology platform to develop novel Ribosome Modulating Agents (RMAs) as therapeutics for people with limited treatment options. Zikani’s TURBO-ZMTM platform allows rapid synthesis of novel compounds that can be optimized to modulate the ribosome in a disease specific manner. As the company evolves its focus from early-stage to clinical-stage research, Zikani is actively moving into pre-clinical development to target select rare diseases including inherited diseases and cancers caused by nonsense mutations. For more information, visit zikani.com.

Forward-Looking Statements

This press release contains forward-looking statements, which are generally statements that are not historical facts. Forward-looking statements can be identified by the words “expects,” “anticipates,” “believes,” “intends,” “estimates,” “plans,” “will,” “outlook” and similar expressions. Forward-looking statements are based on management’s current plans, estimates, assumptions and projections, and speak only as of the date they are made. We undertake no obligation to update any forward-looking statement in light of new information or future events, except as otherwise required by law. Forward-looking statements involve inherent risks and uncertainties, most of which are difficult to predict and are generally beyond our control. Actual results or outcomes may differ materially from those implied by the forward-looking statements as a result of the impact of a number of factors, including: the development of the Company’s readthrough technology; the approval of the Company’s patent applications; the Company’s ability to successfully defend its intellectual property or obtain necessary licenses at a cost acceptable to the Company, if at all; the successful implementation of the Company’s research and development programs and collaborations; the Company’s ability to obtain applicable regulatory approvals for its current and future product candidates; the acceptance by the market of the Company’s products should they receive regulatory approval; the timing and success of the Company’s preliminary studies, preclinical research, clinical trials, and related regulatory filings; the ability of the Company to consummate additional financings as needed; the impact of global health concerns, such as the COVID-19 global pandemic, on our ability to continue our clinical and preclinical programs and otherwise operate our business effectively, including successfully integrating the combined companies; as well as those discussed in more detail in our Annual Report on Form 10-K and our other reports filed with the Securities and Exchange Commission.

Contact

Investors
John Woolford
john.woolford@westwicke.com
443.213.0506

Media
Laureen Cassidy
laureen@outcomescg.com

Mar 24
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Aura Biosciences Expands Executive Leadership Team with the Appointment of Mark De Rosch, Ph.D., as Chief Operating Officer

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

 

March 24, 2021

CAMBRIDGE, MA – March 24, 2021 – Aura Biosciences, a clinical-stage oncology company developing a novel class of virus-like drug conjugate (VDC) therapies for multiple oncology indications, today announced the appointment of Mark De Rosch, Ph.D. as Chief Operating Officer. In his role, he will be responsible for leading Aura’s global operations and regulatory strategy.

Dr. De Rosch brings to Aura more than 30 years of experience in leading global regulatory and development strategies across many therapeutic areas, including oncology and ophthalmology. He has expertise in transitioning companies from early-stage to late-stage and in building effective teams to achieve clinical and corporate objectives.

“Mark joins our team during an exciting time at Aura. His decades of experience with global regulatory strategy, as well as building successful teams and pipelines, will be invaluable as we work to realize the full potential of our VDC technology platform,” said Elisabet de los Pinos, Ph.D., founder and CEO of Aura. “His proven track record and strong scientific acumen aligns well with our goals as we advance AU-011 toward late-stage pivotal development.”

“I am delighted to join Aura at this important time in the Company’s history and I look forward to being part of its promising future, as we work to become a leader in ocular oncology,”

said Dr. De Rosch.

“Aura’s experienced team and the novel VDC technology make this a compelling opportunity. I look forward to contributing my global regulatory, operational and organizational expertise to grow the Company and advance this leading technology to transform the outcomes for cancer patients.”

Dr. De Rosch joins Aura from Epizyme, where he served as Chief Regulatory Officer and led regulatory efforts for their first approved product, TAZVERIK® (tazemetostat). Prior to Epizyme, Dr. De Rosch served as Senior Vice President, Regulatory Affairs and Quality Assurance for Nightstar Therapeutics (acquired by Biogen in 2019), where he developed and implemented global regulatory roadmaps for their gene therapy programs in choroideremia and retinitis pigmentosa. Prior to Nightstar, he served as Senior Vice President, Regulatory Affairs, Quality Assurance and CMC at Akebia Therapeutics.  Before that, Dr. De Rosch served in roles of increasing responsibility at several life science and healthcare consulting firms. Dr. De Rosch holds a Ph.D. and an M.S. in inorganic chemistry from the University of California, San Diego and a B.S. in chemistry/biochemistry from the University of Wisconsin-Parkside.

About Aura Biosciences

Aura Biosciences, Inc. is a clinical-stage oncology company developing a novel technology platform based on virus-like drug conjugates (VDCs) to target and destroy cancer cells selectively while activating the immune system to create long lasting anti-tumor immunity. The VDC technology platform is based on the pioneering discoveries of NIH distinguished investigator Dr. John Schiller of the Center for Cancer Research at the National Cancer Institute (NCI), recipient of the 2017 Lasker-DeBakey Award. The company has the goal of developing this technology in multiple cancer indications with an initial focus in ocular oncology, a group of rare diseases that have no drugs approved. Aura’s lead product candidate belzupacap sarotalocan (AU-011) is currently in Phase 2 development for the first line treatment of choroidal melanoma, a vision and life-threatening form of eye cancer where standard of care radioactive treatments leave patients with major vision loss and severe comorbidities. In a Phase 1b/2 study, AU-011 demonstrated compelling efficacy, including high rates of tumor control and vision preservation including patients with tumors close to the fovea and optic disk, along with a favorable safety profile. Future pipeline applications for Aura’s technology include additional ocular oncology indications like choroidal metastases and solid tumor indications like non-muscle invasive bladder cancer.  Aura is headquartered in Cambridge, MA. For more information, visit www.aurabiosciences.com or follow us on Twitter.

Investor and Media Contact:

Joseph Rayne

Argot Partners

617.340.6075 | joseph@argotpartners.com

Mar 18
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Aura Biosciences Announces Oversubscribed $80 Million Financing

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

 

Proceeds to Support Pivotal Program of AU-011 for the First Line Treatment of Choroidal Melanoma and Expansion of Virus-like Drug Conjugate (VDC) Platform in additional Ocular Oncology Indications and Solid Tumors

Lead Investors Matrix Capital Management and Surveyor Capital (a Citadel company) are Joined by New Investors Rock Springs Capital and Adage Capital Management LP, Along with All Existing Institutional Investors

CAMBRIDGE, MA – March 18, 2021 – Aura Biosciences, a clinical-stage oncology company developing a novel class of virus-like drug conjugate (VDC) therapies for multiple oncology indications, today announced the closing of an oversubscribed $80 million financing. The financing was led by Matrix Capital Management and Surveyor Capital (a Citadel company) with participation from new investors, including Rock Springs Capital, Adage Capital Management LP and Velosity Capital. Existing investors Medicxi, Advent Life Sciences, Lundbeckfonden Ventures, Arix Bioscience, Chiesi Ventures, Ysios Capital and Columbus Venture Partners also participated in the round.

Aura intends to use the proceeds from this financing to advance the clinical development of its VDC technology platform, including the pivotal Phase 3 program for AU-011, the Company’s lead candidate in development for the first line treatment of choroidal melanoma, and ongoing research for additional programs in ocular oncology, as well as expanding the VDC technology into bladder cancer, the first non-ophthalmic solid tumor indication.

“Aura is pioneering the development of a new class of targeted therapies for life-threatening cancers with our novel VDC technology platform. This funding from a syndicate of distinguished investors enables us to advance AU-011 into a pivotal Phase 3 program for the first line treatment of choroidal melanoma, a rare, life- and vision-threatening form of cancer with no drugs approved. It also allows us to continue to expand the reach of our VDC technology in additional ocular oncology indications and in the treatment of solid tumors like bladder cancer where there is a high unmet medical need for better targeted therapies to treat early and reduce the incidence of metastasis,”

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

In connection with this financing, Karan Takhar, Senior Managing Director of Matrix Capital Management, will join Aura’s Board of Directors.

Mr. Takhar said,

“Matrix believes in the long-term potential of Aura’s VDC technology to further strengthen the Company’s position as a leader in ocular oncology and beyond within other types of cancers in need of better treatment options. We look forward to supporting Aura’s leadership team through this next stage of pipeline growth and transition into late-stage development with the commencement of the AU-011 pivotal program.”

About AU-011 (belzupacap sarotalocan)

AU-011 is a first-in-class virus-like drug conjugate (VDC) therapy in development for the first line treatment of choroidal melanoma. The virus-like component of the VDC selectively binds unique heparan sulphate proteoglycans (HSPGs) that are modified and overexpressed on the tumor cell surface of choroidal melanoma cells (and other tumors) and delivers a potent cytotoxic drug that is activated with infrared light. Upon activation with an ophthalmic laser, the cytotoxic drug rapidly and specifically disrupts the cell membrane of malignant melanoma cells with a pro-immunogenic cell death that is believed to activate the immune system generating long term anti-tumor immunity. The unique specificity of tumor binding by the VDC enables the preservation of key eye structures, which may allow for the potential of preserving patients’ vision and reducing other long-term complications of radiation treatment. The possibility of early treatment intervention and the activation of the immune system could lead to a reduction in the metastatic rate for patients with this life-threatening disease. AU-011 can be delivered using equipment commonly found in an ophthalmologist’s office and does not require a surgical procedure, pointing to a potentially less invasive, more convenient therapy for patients and physicians. AU-011 for the treatment of choroidal melanoma has been granted Orphan Drug and Fast Track designations by the U.S. Food and Drug Administration and is currently in Phase 2 clinical development.

About Aura Biosciences

Aura Biosciences, Inc. is a clinical-stage oncology company developing a novel technology platform based on virus-like drug conjugates (VDCs) to target and destroy cancer cells selectively while activating the immune system to create long lasting anti-tumor immunity. The VDC technology platform is based on the pioneering discoveries of NIH Distinguished Investigator Dr. John Schiller of the Center for Cancer Research at the National Cancer Institute (NCI). The company has the goal of developing this technology in multiple cancer indications with an initial focus in ocular oncology, a group of rare diseases that have no drugs approved. Aura’s lead product candidate belzupacap sarotalocan (AU-011) is currently in Phase 2 development for the first line treatment of choroidal melanoma, a vision and life-threatening form of eye cancer where standard of care radioactive treatments leave patients with major vision loss and severe comorbidities. Aura has demonstrated the efficacy and safety of AU-011 in a Phase 1b/2 trial, including high rates of tumor control and vision preservation. Future pipeline applications for Aura’s technology include additional ocular oncology indications like choroidal metastases and solid tumor indications like non-muscle invasive bladder cancer. Aura is headquartered in Cambridge, MA. For more information, visit www.aurabiosciences.com or follow us on Twitter.

Investor and Media Contact:
Joseph Rayne
Argot Partners
617.340.6075 | joseph@argotpartners.com

Feb 16
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Centessa Pharmaceuticals Launches with $250 Million Series A Financing and Unveils a New Kind of Pharmaceutical R&D Model

By Centessa Pharmaceuticals, Press Release, Publicly Listed
Press Release.

 

Merger of 10 Privately Held Biotech Companies with Highly Validated Programs Led by Industry Leading Teams to Operate Under Centessa Umbrella

Company Founded by Medicxi with Financing Led by General Atlantic, and Co-led by Vida Ventures and Janus Henderson Investors

Saurabh Saha, M.D., Ph.D., Former Senior Vice President, R&D, and Global Head of Translational Medicine at Bristol Myers Squibb, Appointed as Chief Executive Officer

Moncef Slaoui, Ph.D., Former Chief Scientific Advisor of Operation Warp Speed, Former Chairman of R&D at GlaxoSmithKline, Partner at Medicxi, Appointed as Chief Scientific Officer, Advisor
February 16, 2021 06:30 AM Eastern Standard Time

CAMBRIDGE, Mass. & LONDON–(BUSINESS WIRE)–Centessa Pharmaceuticals (“Centessa”) launched today as a novel asset-centric pharmaceutical company designed and built to advance a portfolio of highly validated programs. Centessa’s asset-centric R&D model applied at scale has assembled best-in-class or first-in-class assets, each of which is led by specialized teams committed to accelerate development and reshape the traditional drug development process. The company was founded by Medicxi and raised $250 million in an oversubscribed Series A financing led by General Atlantic and co-led by Vida Ventures and Janus Henderson Investors. Additional blue-chip investors participated in the financing, including Boxer Capital, Cormorant Asset Management, T. Rowe Price Associates, Inc., Venrock Healthcare Capital Partners, Wellington Management Company, BVF Partners L.P., EcoR1 Capital, Franklin Templeton, Logos Capital, Samsara BioCapital, LifeSci Venture Partners and an undisclosed U.S.-based, healthcare-focused fund.

“This approach encourages an environment where scientific teams are incentivized to maintain an unwavering focus on advancing medicines to key go/no-go inflection points based on data-driven decisions.”

In conjunction with its launch, Centessa has completed the merger of 10 private biotech companies (“Centessa Subsidiaries”) that will each continue to develop its assets with oversight from the Centessa management team. Each Centessa Subsidiary team is asset-focused, in that it prosecutes a single program or biological pathway, with leadership provided by subject matter experts who are given a high degree of autonomy to advance each program. With a singular focus on advancing exceptional science, combined with proprietary capabilities, including structure-based drug discovery and design, the subsidiary teams enable Centessa to potentially develop and deliver impactful medicines to patients.

“The vision of Centessa is to build a pharmaceutical company with a unique operational framework that aims to reduce some of the key R&D inefficiencies that classical pharmaceutical companies face because of structural constraints,”

said Francesco De Rubertis, Ph.D., Co-Founder and Partner at Medicxi and Chairman of the Centessa Pharmaceuticals Board of Directors.

“Our operations will be driven by an asset-centric approach, whereby each Centessa Subsidiary is solely focused on the execution of its programs with oversight from the highly experienced Centessa management team. The ambition of applying asset centricity at scale is to be able to deliver life altering medicines to patients with improved efficiency by boosting R&D productivity.”

Our Approach
Centessa brings together 10 companies from Medicxi’s portfolio with 15 high conviction programs led by experienced teams. Each Centessa Subsidiary is led by industry leaders and subject matter experts with deep experience directly related to key biological pathways that underpin the programs being advanced. These entrepreneurs who have catalyzed the creation of subsidiary companies will continue to advance novel science within the Centessa enterprise.

The Centessa Subsidiaries are comprised of ApcinteX, Capella BioScience, Janpix, LockBody, Morphogen-IX, Orexia Therapeutics, Palladio Biosciences, PearlRiver Bio, Pega-One and Z Factor. The current Centessa Pharmaceuticals portfolio consists of four clinical stage programs, including two that are in late-stage clinical development, and more than 10 additional programs spanning diseases with high unmet need across oncology, hematology, immunology, inflammation, neuroscience and rare diseases.

“With this first-of-its-kind model, we are bringing together programs with robust genetic and biological validation under one new pharmaceutical company that provides centralized resources to enable and empower asset-focused teams to advance highly impactful programs for patients,”

said Saurabh Saha, M.D., Ph.D., Centessa’s Chief Executive Officer.

“This approach encourages an environment where scientific teams are incentivized to maintain an unwavering focus on advancing medicines to key go/no-go inflection points based on data-driven decisions.”

Centessa will have the flexibility to deploy capital by adhering to a “follow-the-data” philosophy and will support each Centessa Subsidiary with centralized capabilities that enable advancement of its respective programs. These include manufacturing, regulatory and operational support to enable and expedite scientific prosecution of programs by subsidiary teams. Each team is uniquely incentivized to expeditiously interrogate key scientific hypotheses.

Moncef Slaoui, Ph.D, Chief Scientific Officer, Advisor of Centessa added,

“In creating Centessa, we have strategically assembled our subsidiary portfolio to include programs with strong biological validation, mechanistic diversification, and teams with proprietary capabilities and insights. This high-quality portfolio aims to deliver enhanced diversification, reduced risk and asymmetric upside with a view to withstanding the inherent low probability of success associated with drug development.”

Meet the Team
The Centessa Pharmaceuticals management team consists of biotech and pharmaceutical industry leaders who oversee decisions related to capital allocation, development plans and strategic transactions in partnership with the Centessa Subsidiaries.

Saurabh Saha, M.D., Ph.D., former Senior Vice President, R&D, and Global Head of Translational Medicine at Bristol Myers Squibb, has been appointed as the company’s Chief Executive Officer and a member of the Board of Directors. In addition, Moncef Slaoui, Ph.D., former Chief Scientific Advisor of Operation Warp Speed, former Chairman of R&D at GlaxoSmithKline, and Partner at Medicxi, has been appointed as Chief Scientific Officer, Advisor.

The Centessa Board of Directors includes Francesco De Rubertis, Ph.D., Medicxi, who will serve as the company’s Chairman; Aaron Kantoff, Medicxi; Brett Zbar, M.D., General Atlantic; and Arjun Goyal, M.D., M.Phil., Vida Ventures.

“We believe Centessa represents a unique opportunity in our sector,”

said Brett Zbar, M.D., Managing Director and Global Head of Life Sciences at General Atlantic.

“The high-quality science and entrepreneurial drive within each of the Centessa Subsidiaries, combined with this deeply experienced leadership team, has the potential to bring important medicines to patients with speed and efficiency.”

“Centessa’s bold vision and unique operating model are supported by compelling clinical programs, strong data and a stellar team,” said Arjun Goyal, M.D., M.Phil., Co-Founder and Managing Director at Vida Ventures. “We believe Centessa’s approach can ultimately lead to impactful medicines that will benefit patients globally.”

ABOUT THE CENTESSA SUBSIDIARIES

ApcinteX
ApcinteX is developing SerpinPC, a specific inhibitor of the anticoagulant protease activated protein C (APC), for the treatment for hemophilia A and hemophilia B, with or without inhibitors.

Capella BioScience
Capella BioScience is developing CBS001, a neutralizing therapeutic monoclonal antibody to the inflammatory membrane form of LIGHT (known as TNFSF14), for the treatment of idiopathic pulmonary fibrosis. Capella BioScience is also developing CBS004, a therapeutic monoclonal antibody to blood dendritic cell antigen 2 (BDCA2), for the treatment of lupus erythematosus (systemic and cutaneous) and systemic sclerosis.

Janpix
Janpix is developing a novel class of selective dual-STAT3/5 small molecule monovalent degraders for the treatment of various hematological malignancies, including leukemias and lymphomas.

LockBody
LockBody is pioneering a platform technology to develop LockBody CD47 (LB1) and LockBody CD3 (LB2) for optimal targeting of solid tumors by the innate immune system.

Morphogen-IX
Morphogen-IX is developing MGX292, a protein-engineered variant of human bone morphogenetic protein-9 (BMP9), for the treatment of pulmonary arterial hypertension.

Orexia Therapeutics
Orexia Therapeutics is developing oral and intranasal orexin receptor agonists using structure-based drug design approaches. These agonists target the treatment of narcolepsy type 1, where they have the potential to directly address the underlying pathology of orexin neuron loss, as well as other neurological disorders characterized by excessive daytime sleepiness.

Palladio Biosciences
Palladio Biosciences is developing lixivaptan, an oral non-peptide, new chemical agent that works by selectively suppressing the activity of the hormone vasopressin at the V2 receptor, as a treatment for autosomal dominant polycystic kidney disease with the goal of slowing the progression of kidney function decline and avoiding the liver safety issues associated with tolvaptan.

PearlRiver Bio
PearlRiver Bio is developing ​potent and selective oral exon20 insertion mutation inhibitors intended to have ​minimal activity on wild-type EGFR and optimal pharmacokinetic properties, ​for the treatment of EGFR exon 20 insertion (with potential to target and treat Her2 exon 20 insertions) non-small cell lung cancer (NSCLC). PearlRiver Bio is also developing oral inhibitors targeting C797S-mutant EGFR and undisclosed next generation EGFR inhibitors for NSCLC.

PegaOne
PegaOne is developing imgatuzumab, a humanized, non-fucosylated, anti-EGFR monoclonal antibody for the treatment of cutaneous squamous cell carcinoma and other solid tumor indications.

Z Factor
Z Factor is developing ZF874, a small molecule chemical chaperone intended to rescue folding of the Z variant of alpha-1-antitrypsin, increasing serum levels of active protein and reducing accumulation in the liver, for the treatment of alpha-1-antitrypsin deficiency.

ABOUT CENTESSA PHARMACEUTICALS

Centessa Pharmaceuticals Limited is a next-generation biopharmaceutical company that aims to reshape the traditional drug development process. The company applies an asset-centric R&D model at scale to advance a portfolio of highly validated programs led by industry leading teams. Each program is developed by an Centessa Subsidiary and supported by a centralized infrastructure and the Centessa management team. The company is headquartered in Cambridge, Mass. For more information, visit www.centessa.com

FORWARD-LOOKING STATEMENTS

This press release contains forward-looking statements. Statements we make in this press release may include statements that are not historical facts and are considered forward-looking within the meaning of Section 27A of the Securities Act of 1933, as amended (the “Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), which are usually identified by the use of words such as “estimates,” “expects,” “intends,” “anticipates,” “believes,” “may,” “should,” “will,” “plans,” “projects,” “seeks,” and variations of such words or similar expressions. We intend these forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act and Section 21E of the Exchange Act and are making this statement for purposes of complying with those safe harbor provisions. These forward-looking statements, including statements relating to expectations, plans and prospects regarding the clinical development plans and timing, clinical trial designs, clinical and therapeutic potential, and strategy for any of our programs reflect our current views about our plans, intentions, expectations, strategies and prospects, which are based on the information currently available to us and on assumptions we have made. Although we believe that our plans, intentions, expectations, strategies and prospects as reflected in or suggested by those forward-looking statements are reasonable, we can give no assurance that the plans, intentions, expectations or strategies will be attained or achieved. Furthermore, actual results may differ materially from those described in the forward-looking statements and will be affected by a number of risks, uncertainties and assumptions, including, but not limited to, the success of clinical trials, regulatory filings, and approvals. These forward-looking statements are based upon the current expectations and beliefs of Centessa’s management team as of the date of this release and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Furthermore, Centessa operates in a very competitive and rapidly changing environment in which new risks emerge from time to time. Except as required by applicable law, we assume no obligation to update publicly any forward-looking statements, whether as a result of new information, future events or otherwise.

Contacts

Media:
Dan Budwick, 1AB
dan@1abmedia.com

UK/European media enquiries
Optimum Strategic Communications
Mary Clark, Shabnam Bashir
centessa@optimumcomms.com

Swiss media enquiries
VEITHing Spirit
Marcus Veith
marcus@vspirit.ch
Cellphone: +41 79 20 75 111

Jan 25
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Iterum Therapeutics Announces U.S. FDA Filing Acceptance of New Drug Application for Oral Sulopenem

By Iterum, Press Release, Publicly Listed
Press Release.

 

If approved, First Oral Penem in the U.S. and First New Oral Treatment for uUTIs in Over 20 Years

PDUFA goal date of July 25, 2021

DUBLIN, Ireland and CHICAGO, Jan. 25, 2021 (GLOBE NEWSWIRE) — Iterum Therapeutics plc (Nasdaq: ITRM) (the Company), a clinical-stage pharmaceutical company focused on developing next generation oral and IV antibiotics to treat infections caused by multi-drug resistant pathogens in both community and hospital settings, today announced that the U.S. Food and Drug Administration (FDA) accepted for review the New Drug Application (NDA) for sulopenem etzadroxil/probenecid (oral sulopenem) for the treatment of uncomplicated urinary tract infections (uUTIs) in patients with a quinolone non-susceptible pathogen. The FDA has designated this application as a priority review and consequently assigned a PDUFA (Prescription Drug User Fee Act) goal date for completion of the review of oral sulopenem of July 25, 2021. The agency currently plans to hold an advisory committee meeting to discuss the NDA.

“The FDA acceptance of our NDA for review is an important milestone for Iterum. If approved, oral sulopenem would be the first penem available orally in the U.S. with the ability to treat multi-drug resistant infections in the community,”

said Corey Fishman, Chief Executive Officer.

“Specifically, this important antibiotic is one step closer to relieving the growing problem of quinolone resistance found in over six million uncomplicated urinary tract infections in the U.S. each year.”

The NDA includes data from the SURE-1, SURE-2 and SURE-3 phase 3 clinical trials, in which oral sulopenem was well tolerated. The SURE-1 clinical trial (uUTIs) demonstrated statistical superiority of oral sulopenem to the widely used comparator, ciprofloxacin, for the primary efficacy endpoint of clinical and microbiologic response at the test-of-cure visit for patients with a quinolone non-susceptible pathogen.

About Iterum Therapeutics plc

Iterum Therapeutics plc is a 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 Therapeutics is advancing its first compound, sulopenem, a novel penem anti-infective compound, in Phase 3 clinical development with an oral formulation and IV formulation. Sulopenem has demonstrated potent in vitro activity against a wide variety of gram-negative, gram-positive and anaerobic bacteria resistant to other antibiotics. Iterum Therapeutics has received Qualified Infectious Disease Product (QIDP) and Fast Track designations for its oral and IV formulations of sulopenem in seven indications.

Forward-Looking Statements

This press release contains forward-looking statements. These forward-looking statements include, without limitation, statements regarding, among other things, timing of the review of regulatory filings and the market opportunity for, and potential market acceptance of, oral sulopenem for uUTIs, and the Company’s plans, strategies and prospects for its business. In some cases, forward-looking statements can be identified by words such as “may,” “believes,” “intends,” “seeks,” “anticipates,” “plans,” “estimates,” “expects,” “should,” “assumes,” “continues,” “could,” “would,” “will,” “future,” “potential” or the negative of these or similar terms and phrases. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause the Company’s actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Forward-looking statements include all matters that are not historical facts. Actual future results may be materially different from what is expected due to factors largely outside the Company’s control, including the uncertainties inherent in the initiation and conduct of clinical trials,  availability and timing of data from clinical trials, changes in regulatory requirements or decisions of regulatory authorities, the timing of approval of any submission, changes in public policy or legislation, commercialization plans and timelines, if oral sulopenem is approved, the actions of third-party clinical research organizations, suppliers and manufacturers, the accuracy of the Company’s expectations regarding how far into the future the Company’s cash on hand will fund the Company’s ongoing operations, the sufficiency of the Company’s cash resources and the Company’s ability to continue as a going concern, the impact of COVID-19 and related responsive measures thereto, the Company’s ability to maintain listing on the Nasdaq Capital Market, risks and uncertainties concerning the outcome, impact, effects and results of the Company’s evaluation of corporate, organizational, strategic, financial and financing alternatives, including the terms, timing, structure, value, benefits and costs of any corporate, organizational, strategic, financial or financing alternative and the Company’s ability to complete one at all, the price of the Company’s securities and other factors discussed under the caption “Risk Factors” in its most recently filed Quarterly Report on Form 10-Q, and other documents filed with the SEC from time to time. Forward-looking statements represent the Company’s beliefs and assumptions only as of the date of this press release. Except as required by law, the Company assumes no obligation to update these forward-looking statements publicly, or to update the reasons actual results could differ materially from those anticipated in the forward-looking statements, even if new information becomes available in the future.

Investor Contact:
Judy Matthews
Chief Financial Officer 312-778-6073
IR@iterumtx.com

Source: Iterum Therapeutics plc

Jan 05
Love0

Aura Biosciences Appoints David Johnson to Its Board of Directors

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

 

CAMBRIDGE, MA –January 5th, 2021– Aura Biosciences, a clinical-stage oncology company developing a novel class of drug conjugate therapies for multiple oncology indications, today announced the appointment of David Johnson to its Board of Directors. Mr. Johnson is a biopharmaceutical business leader with more than 25 years of experience in drug development and currently serves as Chief Executive Officer at VelosBio, a clinical-stage oncology company developing novel antibody-drug-conjugates and bispecific antibodies.

“With David’s impressive track record in oncology and as an accomplished CEO, his engagement and guidance will help Aura drive AU-011 for the treatment of choroidal melanoma to registration and commercialization,”

said George Golumbeski, Ph.D., Chairman of the Board of Aura Biosciences.

“In the last few years, David has led several biopharma transactions, including the acquisition of VelosBio by Merck for $2.75 billion. He has also successfully raised over $500 million in capital for his last two companies. We are really excited to have David’s strategic guidance as we work to accelerate the clinical development of our pipeline of innovative oncology therapies.”

“I am excited to be joining Aura’s Board of Directors during such an important period of growth for the Company,”

said Mr. Johnson.

“I look forward to leveraging my extensive clinical, business development, operational and executive leadership experience in the biotechnology industry to support Aura’s Board of Directors and leadership team in achieving their goal of advancing a new class of oncology drugs for life-threatening cancers.”

Prior to founding VelosBio, Mr. Johnson was the Chief Executive Officer at Acerta Pharma, an oncology-focused pharmaceutical company, where he led the Company through a critical phase of growth from approximately 40 to over 150 employees and from a signal-seeking, first-in-human trial to more than 20 active clinical studies. Under his leadership, Acerta designed and launched three registration-directed trials, including two global Phase 3 trials for acalabrutinib, an irreversible oral Bruton’s tyrosine kinase (BTK) inhibitor initially focused on hematological malignancies. Mr. Johnson and his leadership team ultimately led the acquisition of Acerta by AstraZeneca in a deal valued at up to $7 billion.

Before Acerta, Mr. Johnson held roles with increasing responsibility within commercial, pipeline development, medical affairs, and clinical development organizations at various healthcare companies including Hoffman-La Roche, Immunex (acquired by Amgen), Millennium (acquired by Takeda), Favrille, Gloucester (acquired by Celgene), and Calistoga (acquired by Gilead). He has made significant contributions to drugs ultimately garnering regulatory approvals, including bortezomib (Velcade®), romidepsin (Istodax®), idelalisib (Zydelig®), and acalabrutinib (Calquence®). In addition to Aura’s Board, Mr. Johnson serves on the Board of Directors of Zentalis Pharmaceuticals, a clinical-stage biopharmaceutical company focused on discovering and developing small molecule therapeutics targeting fundamental biological pathways of cancers. Mr. Johnson received a Bachelor’s degree from Indiana University.

About Aura Biosciences

Aura Biosciences, Inc. is a clinical-stage biopharmaceutical company developing a new class of oncology therapies based on a novel drug conjugate technology for initial application in ocular and bladder cancers with the potential to treat other cancers. The Company’s proprietary technology platform utilizes virus-like drug conjugates (VDCs) that have a dual mechanism of action with targeted necrosis of cancer cells, followed by a T-cell mediated anti-tumor response. This novel technology platform uses Virus-Like Particles to bind to a novel tumor cell surface target and can deliver hundreds of cytotoxic molecules selectively to tumor cells, while sparing surrounding healthy tissue. Aura’s lead product candidate belzupacap sarotalocan (AU-011) is currently in Phase 2 development for the first line treatment of choroidal melanoma, a vision and life-threatening form of eye cancer for which there are currently no approved therapies. In a Phase 1b/2 study, AU-011 demonstrated compelling efficacy, including high rates of tumor control and vision preservation, along with a favorable safety profile, in patients with choroidal melanoma. Future pipeline applications for Aura’s technology include choroidal metastases and non-muscle invasive bladder cancer.  Aura is headquartered in Cambridge, MA. For more information, visit www.aurabiosciences.com or follow us on Twitter.

Investor and Media Contact:

Joseph Rayne

Argot Partners

617.340.6075 | joseph@argotpartners.com

Aug 06
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Acutus Medical Announces Pricing of Initial Public Offering

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

 

August 6, 2020

CARLSBAD, Calif., Aug. 05, 2020 (GLOBE NEWSWIRE) — Acutus Medical, Inc. (“Acutus”) (NASDAQ: AFIB) today announced the pricing of its initial public offering of 8,823,529 shares of its common stock at a price to the public of $18.00 per share. All of the shares are being offered by Acutus. The gross proceeds from the offering, before deducting underwriting discounts and commissions and other offering expenses payable by Acutus, are expected to be approximately $158.8 million. The shares are expected to begin trading on The Nasdaq Global Select Market on August 6, 2020, under the symbol “AFIB.” The offering is expected to close on August 10, 2020, subject to the satisfaction of customary closing conditions. In addition, Acutus has granted the underwriters a 30-day option to purchase up to an additional 1,323,529 shares of Acutus’ common stock at the initial public offering price, less the underwriting discounts and commissions.

J.P. Morgan and BofA Securities are acting as joint book-running managers. William Blair is also acting as book-running manager. Canaccord Genuity and BTIG are acting as co-managers.

Registration statements relating to these securities have been filed with the Securities and Exchange Commission and became effective on August 5, 2020. The offering is being made only by means of a prospectus. Copies of the final prospectus, when available, may be obtained from J.P. Morgan Securities LLC, Attention: Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, by telephone at (866) 803-9204, or by email at prospectus-eq_fi@jpmchase.com; BofA Securities, NC1-004-03-43, 200 North College Street, 3rd floor, Charlotte, NC 28255-0001, Attention: Prospectus Department, or by email at dg.prospectus_requests@bofa.com; or William Blair & Company, L.L.C., Attention: Prospectus Department, 150 North Riverside Plaza, Chicago, IL 60606, by telephone at (800) 621-0687, or by email at prospectus@williamblair.com.

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 of these securities under the securities laws of any such state or jurisdiction.

About Acutus Medical, Inc.
Acutus Medical is an arrhythmia management company focused on improving the way cardiac arrhythmias are diagnosed and treated. Acutus is committed to advancing the field of electrophysiology with a unique array of products and technologies which will enable more physicians to treat more patients more efficiently and effectively. Through internal product development, acquisitions and global partnerships, Acutus has established a global sales presence delivering a broad portfolio of highly differentiated electrophysiology products that provide its customers with a complete solution for catheter-based treatment of cardiac arrhythmias. Founded in 2011, Acutus is based in Carlsbad, California.

Investor Contact:
Caroline Corner
Westwicke ICR
D: 415-314-1725
Caroline.corner@westwicke.com

Holly Windler
M: 619-929-1275
media@acutusmedical.com

Caution Regarding Forward-Looking Statements
This press release includes statements that may constitute “forward-looking” statements, usually containing the words “believe,” “estimate,” “project,” “expect” or similar expressions. These forward-looking statements include, without limitation, references to Acutus’ expectations regarding the commencement of trading on The Nasdaq Global Select Market and the completion, timing and size of the public offering. Forward-looking statements inherently involve risks and uncertainties that could cause actual results to differ materially from the forward-looking statements. Factors that would cause or contribute to such differences include, but are not limited to, risks and uncertainties related to completion of the public offering and the satisfaction of customary closing conditions related to the public offering. Additional factors that would cause or contribute to such differences include, but are not limited to, the Company’s ability to continue to manage expenses and cash burn rate at sustainable levels, continued acceptance of the Company’s products in the marketplace, the effect of global economic conditions on the ability and willingness of customers to purchase its systems and the timing of such purchases, competitive factors, changes resulting from healthcare policy in the United States, including changes in government reimbursement of procedures, dependence upon third-party vendors, timing of regulatory approvals, the impact of the recent coronavirus (COVID-19) pandemic and our response to it, and other risks discussed in the Company’s periodic and other filings with the Securities and Exchange Commission. By making these forward-looking statements, the Company undertakes no obligation to update these statements for revisions or changes after the date of this release

Apr 26
Love0

Acutus Medical’s New Contact Mapping Software Receives CE Mark

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

 

FDA Clears Robust Second Generation AcQMap Platform

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

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

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

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

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

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

said Acutus Medical CEO Vince Burgess.

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

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

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

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

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

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

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

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

Apr 02
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Aura Biosciences Completes $40 Million Series D Financing

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

 

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

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

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

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

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

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

About Choroidal Melanoma

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

About Light-Activated AU-011

AU-011 is a first-in-class targeted therapy in development for the primary treatment of choroidal melanoma. The therapy consists of proprietary viral-like particle bioconjugates (VPB) that are activated with an ophthalmic laser. The VPBs bind selectively to unique receptors on cancer cells in the eye and are derived from technology originally pioneered by Dr. John Schiller of the Center for Cancer Research at the National Cancer Institute (NCI), recipient of the 2017 Lasker-DeBakey Award. Upon activation with an ophthalmic laser, the VPB rapidly and specifically disrupts the cell membrane of tumor cells while sparing key eye structures, which may allow for the potential of preserving patients’ vision and reducing other long-term complications of radiation treatment. AU-011 can be delivered using equipment commonly found in an ophthalmologist’s office and does not require a surgical procedure, pointing to a potentially less invasive, more convenient therapy for patients and physicians. AU-011 for the treatment of choroidal melanoma has been granted orphan drug and fast track designations by the U.S. Food and Drug Administration and is currently in clinical development.

About Aura Biosciences

Aura Biosciences is developing a new class of therapies to selectively target and destroy cancer cells. Its lead program, AU-011 in primary choroidal melanoma, is being developed under a CRADA with the National Cancer Institute (NCI), part of the National Institutes of Health. Current institutional investors participating in the financing includes Advent Life Sciences, Arix Bioscience, Chiesi Ventures, Columbus Venture Partners, Lundbeck Ventures and Ysios Capital. For more information, visit www.aurabiosciences.com.

About Medicxi

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

Contacts:

Media:

David Rosen

Argot Partners

212.600.1902 | david.rosen@argotpartners.com

Investors:

Joseph Rayne

Argot Partners

617.340.6075 | joseph@argotpartners.com

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