Abeona Reports Third Quarter 2017 Financial Results and Recent Business Highlights
- Investor Conference Call to be held Monday, November 20th at 10:00 am ET
- Global enrollment continues in ABO-102 trial for MPS IIIA
- Screening initiated in ABO-101 Phase 1/2 trial for MPS IIIB
- Pivotal Phase 3 planning underway for EB-101 program in RDEB
NEW YORK and CLEVELAND, Nov. 15, 2017 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (NASDAQ:ABEO), a leading clinical-stage biopharmaceutical company focused on developing novel gene therapies for life-threatening rare diseases, announced financial results for the third quarter and recent business highlights. The Company will provide investors an update on recent and ongoing business activities and an overview of its 3Q17 financials on Monday, November 20th, at 10:00 am (Eastern). Interested parties are invited to participate in the call by dialing 877-269-7756 (toll free domestic) or 201-689-7817 (international).
"The third quarter was marked with achievements across multiple clinical programs, including initiating enrollments at our global clinical sites for ABO-102 for MPS IIIA and reporting additional data that underscored the durability and clinical benefit of the gene therapy. Our Epidermolysis Bullosa program achieved FDA Breakthrough Therapy designation, completed its Phase 1/2 clinical trial and continues to advance as we finalize the clinical protocol before initiating the pivotal Phase 3 trial next year. We were pleased to have recently initiated screening in our MPS IIIB program and look forward to commencing enrollments shortly," stated Timothy J. Miller, Ph.D., President and CEO. "In addition, work in optimizing our AIM(TM) vector platform demonstrated exciting progress, including enhanced tissue tropisms compared to naturally occurring AAV capsids."
3rd Quarter Summary Financial Results:
- Cash position: Cash and cash equivalents as of September 30, 2017 were $56.5 million, compared to $58.3 million as of June 30, 2017. Net cash used in operating activities in the nine months ended September 30, 2017 was $17.6 million as compared to $9.6 million in the same period in 2016. Cash and cash equivalents includes approximately $5 million from exercised warrants in the third quarter. Subsequent to the end of the third quarter, the Company closed a public offering of common stock with gross proceeds of $92 million. Total cash as of October 31, 2017 was $142.6 million.
- Revenues: Revenues were $219 thousand for the third quarter of 2017, compared to $184 thousand in the third quarter of 2016. Revenues consisted of a combination of royalties from marketed products, primarily MuGard®, and recognition of deferred revenues related to upfront payments from early license agreements.
- Loss per share: Loss per share was $0.13 for the third quarter of 2017, compared to a loss per share of $0.08 in the comparable period in 2016.
Abeona Recent Highlights:
- November 9, 2017: Enrolled First Subject at Spain Clinical Site in Ongoing Phase 1/2 Clinical Trial in MPS IIIA
- October 19, 2017: Announced Closing of $92 Million Underwritten Public Offering and Full Exercise of Underwriters' Option to Purchase Additional Shares
- October 16, 2017: Announced a Grant of up to $13.85 Million from Leading Sanfilippo Syndrome Foundations for Clinical Development of MPS III Gene Therapies
- October 11, 2017: Hosted inaugural R&D day and announced enrollment of First Two Patients in Global Expansion of Phase 1/2 Clinical Trial in MPS IIIA
- October 6, 2017: Announced Top-Line One Year Data from ABO-102 MPS IIIA Trial at ARM's Cell & Gene Meeting on the Mesa
- Gene therapy demonstrated durable and significant reduction of underlying disease pathology across multiple clinical measures in Cohort 1 (n=3) compared to a natural history control group (n=8-12)
- Systemic biopotency demonstrated time- and dose-dependent reductions of disease causing Heparan Sulfate in the Cerebrospinal fluid (CSF) and liver volumes
- Preservation of deep brain architecture observed after intravenous administration
- Stabilization of neurocognitive assessment scores at one year post-injection
- October 4, 2017: Announced Dedication of Commercial Gene Therapy Manufacturing Facility in Cleveland, Ohio
- September 28, 2017: Announced Collaboration with Brammer Bio for Commercial Translation of ABO-102
- August 29, 2017: Received FDA Breakthrough Therapy Designation for EB-101 Autologous Cell Therapy in Epidermolysis Bullosa
- July 25, 2017: Announced Appointment of Juan Ruiz, M.D., Ph.D. as Chief Medical Officer
- July 18, 2017: Received Guidance from FDA to Commence Pivotal Phase 3 for EB-101 Gene Therapy for Patients with Epidermolysis Bullosa
"We have made great progress in the quarter towards becoming a key player in the development of novel breakthrough gene and cell therapies for rare genetic diseases," stated Steven H. Rouhandeh, Executive Chairman. "The recent investment from high-quality investors and leading foundations is another achievement that demonstrates our internal capabilities and commitment to the advancement of our robust pipeline and next generation vector platform, including MPS III gene therapy products. We look forward to further strengthening our efforts with key hires, advancing clinical capabilities, and commercial expansion in the coming quarters."
About Abeona: Abeona Therapeutics Inc. is a clinical-stage biopharmaceutical company developing cell and gene therapies for life-threatening rare genetic diseases. Abeona's lead programs include ABO-102 (AAV-SGSH), an adeno-associated virus (AAV) based gene therapy for Sanfilippo syndrome type A (MPS IIIA) and EB-101 (gene-corrected skin grafts) for recessive dystrophic epidermolysis bullosa (RDEB). Abeona is also developing ABO-101 (AAV-NAGLU) for Sanfilippo syndrome type B (MPS IIIB), ABO-201 (AAV-CLN3) gene therapy for juvenile Batten disease (JNCL), ABO-202 (AAV-CLN1) for treatment of infantile Batten disease (INCL), EB-201 for epidermolysis bullosa (EB), ABO-301 (AAV-FANCC) for Fanconi anemia (FA) disorder and ABO-302 using a novel CRISPR/Cas9-based gene editing approach to gene therapy for rare blood diseases. In addition, Abeona is developing a proprietary vector platform, AIM(TM), for next generation product candidates. For more information, visit www.abeonatherapeutics.com.
Vice President, Investor Relations
Abeona Therapeutics Inc.
Berry & Company Public Relations
+1 (212) 253-8881
This press release contains certain statements that are forward-looking within the meaning of Section 27a of the Securities Act of 1933, as amended, and that involve risks and uncertainties. These statements include, without limitation, statements about our ability to develop our products and technologies; our plans for continued development and internationalization of our clinical programs; that patients will continue to be identified, enrolled, treated and monitored in the EB-101 clinical trial, and that studies will continue to indicate that EB-101 is well-tolerated and may offer significant improvements in wound healing and we plan to initiate a pivotal Phase III trial early next year; we have recently initiated screening in our MPS IIIB program and look forward to commencing enrollments by year-end; our expectation that we will continue to advance our gene therapy for MPS IIIA patients, our expectation of accelerating enrollment with our active global sites in Spain and Australia, and that we remain encouraged by signs of tolerability and biological effects observed in Cohort 1 post injection. Such statements are subject to numerous risks and uncertainties, including but not limited to continued interest in our rare disease portfolio, our ability to enroll patients in clinical trials, the impact of competition, the ability to secure licenses for any technology that may be necessary to commercialize our products, the ability to achieve or obtain necessary regulatory approvals, the impact of changes in the financial markets and global economic conditions; our belief that initial signals of biopotency and clinical activity, which suggest that ABO-102 successfully reached target tissues throughout the body, including the central nervous system and the increased reductions in CNS GAG support our approach for intravenous delivery for subjects with Sanfilippo syndromes, risks associated with data analysis and reporting, and other risks as may be detailed from time to time in the Company's Annual Reports on Form 10-K and quarterly reports on Form 10-Q and other reports filed by the Company with the Securities and Exchange Commission. The Company undertakes no obligations to make any revisions to the forward-looking statements contained in this release or to update them to reflect events or circumstances occurring after the date of this release, whether as a result of new information, future developments or otherwise.
The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.
Source: Abeona Therapeutics Inc via Globenewswire
Om Nasdaq GlobeNewswire
One Liberty Plaza - 165 Broadway
NY 10006 New York
+1 212 401 8700http://www.nasdaqomx.com
NASDAQ (NASDAQ: NDAQ) is a leading provider of trading, exchange technology, information and public company services across six continents.
Følg saker fra Nasdaq GlobeNewswire
Registrer deg med din epostadresse under for å få de nyeste sakene fra Nasdaq GlobeNewswire på epost fortløpende. Du kan melde deg av når som helst.
Siste saker fra Nasdaq GlobeNewswire
MBA Hiring is Strong, with 4 in 5 Companies Planning to Hire Graduates in 201821.6.2018 15:00 | Pressemelding
MBA Graduates Commanding Salary Premiums RESTON, Va., June 21, 2018 (GLOBE NEWSWIRE) -- The Graduate Management Admission Council (GMAC) has released its 17th annual survey report, the GMAC 2018 Corporate Recruiters Survey report, and findings indicate that MBA hiring remains strong. Overall, 81 percent of responding companies plan to hire MBA graduates in 2018. Among all respondents globally, 52 percent of companies plan to increase MBA starting base salaries this year. Around the world , MBA graduates continue to command a salary premium relative to direct-from-industry hires and bachelor's degree hires. The projected median base starting salary for recent MBA graduates in the United States in 2018 is US$105,000, compared with US$85,000 for direct-from-industry new hires and US$65,000 for bachelor's degree new hires. The data reflect a slight decline in projected hiring among US and European employers compared to 2017's hiring plans: 85 percent of responding US companies and 64 perce
Clinical data demonstrates significantly increased cure rates using Resistance Guided Therapy for treating the STI Superbug M. genitalium21.6.2018 09:00 | Pressemelding
SpeeDx ResistancePlus® MG test supports new STI management guidelines SYDNEY, Australia, June 21, 2018 (GLOBE NEWSWIRE) -- SpeeDx Pty. Ltd. today announced clinical data contained in a new study published in the June 2018 issue of Clinical Infectious Diseases 1 [link ] supports the use of Resistance Guided Therapy for more effective treatment of Mycoplasma genitalium infections. Using the SpeeDx ResistancePlus® MG test, the authors recorded an overall cure rate of >92%, a significant increase compared with previous cure rates of 67% prior to using Resistance Guided Therapy.ResistancePlus MG test simultaneously detects the sexually transmitted infection (STI) M. genitalium and the genetic markers linked to antimicrobial resistance (AMR). The test is CE marked and in use across Europe, and available in laboratories across Australia and New Zealand. Clinical trials are underway in the U.S. in preparation for de novo clearance for the test with the U.S. Food and Drug Administration. "This
LM Industries Brings Manufacturing Into the Future as World's First Digital OEM20.6.2018 18:00 | Pressemelding
The creators of autonomous shuttle Olli form LM Industries, a company designing and building future-looking products with partners like Allianz, Airbus and the United States Marine Corps SAN FRANCISCO, June 20, 2018 (GLOBE NEWSWIRE) -- Today, the creators of the Rally Fighter and Olli announced the formation of LM Industries Group, Inc., a technology-enabled manufacturer focused on mobility products headquartered in San Francisco. LM Industries is the world's first digital OEM - which can take concepts to deployed products in under one year, all on its unique digital thread. It brings products to market in an entirely new way, designing with its global community of experts, and applying technology such as 3D printing to create and assemble products in small batches at agile microfactories. The process challenges the century-long dependency on mass manufacturing which has failed to keep up with the modern pace of technological innovation. LM Industries creates transportation, accessibil
Anglo American, Milliken & Company, MOL Group, Koch Industries, Goldcorp and AccorHotels among the Excellence Award winners at Enablon's Sustainable Performance Forum20.6.2018 17:15 | Pressemelding
Enablon recognizes companies for effectively leveraging technology to improve their sustainability performance CHICAGO, June 20, 2018 (GLOBE NEWSWIRE) -- Enablon, a Wolters Kluwer business and the world's leading provider of EHS, Operational Risk Management and Sustainability Software, announced today the winners of the 2018 Enablon Excellence Awards. The awards were given during a gala dinner at the Sustainable Performance Forum (SPF) in Chicago, and in Paris. The Enablon Excellence Awards recognize organizations that are leading the way within their industry and that effectively leverage technology to improve their sustainability performance to benefit their business, and also their employees, customers and the communities in which they operate. The 2018 Excellence Awards winners are: Enablon Excellence Award in EHS Performance: Koch Industries (Americas) & MOL Group (EMEA) Enablon Excellence Award in Governance, Risk & Compliance (EMEA): AccorHotels Enablon Excellence Award in Integ
Datameer Named Leader in Ovum Self-Service Data Prep Decision Matrix20.6.2018 15:40 | Pressemelding
Datameer ranked among top vendors for integration and exploration, data manipulation, data governance, and administration SAN FRANCISCO, June 20, 2018 (GLOBE NEWSWIRE) -- Datameer, the leader in big data management for analytics, is pleased to announce that it was named a leader in the Ovum Decision Matrix, Selecting a Self-Service Data Prep Solution, 2018-2019, ahead of Alteryx, Datawatch and Oracle. The report highlights Datameer as "a broad and complex platform [..] focused on building and managing data pipelines that enable data to be fed into any analytic tool." "In the self-service data prep market, we're increasingly seeing the trend of 'platformization' of products, whereby data prep becomes a feature rather than a stand-alone tool," said report author Paige Bartley, senior analyst at Ovum. "Datameer has taken this approach, offering a broad platform focused on data pipelines and self-service enablement. But with a broader platform and functionality comes the need for greater g
Kofax Robotic Process Automation Software Creates Smarter Robots20.6.2018 14:00 | Pressemelding
Kapow 10.3 Adds Artificial Intelligence, Machine Learning and Other Enhancements IRVINE, Calif., June 20, 2018 (GLOBE NEWSWIRE) -- Kofax ®, a leading supplier of software to automate and digitally transform information intensive processes, today announced the addition of artificial intelligence (AI), machine learning and other capabilities in its Kapow(TM) 10.3 Robotic Process Automation (RPA) software. Kapow, the #originalbot, automates and digitally transforms a wide range of human and information intensive processes across front and back office operations. It allows users to develop and deploy smart robots that mimic human actions while driving continuous improvement using AI and machine learning. Kapow robots interact seamlessly across desktop software, traditional enterprise and browser based systems and web sites, aggregating data, transforming it into actionable information, triggering responses, and communicating with other applications. Kapow 10.3 leverages AI and machine lear
I vårt presserom finner du alle våre siste saker, kontaktpersoner, bilder, dokumenter og annen relevant informasjon om oss.Besøk vårt presserom