Abeona Therapeutics Reports First Quarter 2018 Financial Results and Business Highlights
Investor Conference Call on Monday, May 14th at 10:00 am ET
NEW YORK and CLEVELAND, May 11, 2018 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (NASDAQ:ABEO), a leading clinical-stage biopharmaceutical company focused on developing novel cell and gene therapies for life-threatening rare genetic diseases, today announced financial results for the first quarter of 2018. The Company will host a call to update investors on recent clinical developments and quarter financial results on Monday, May 14th at 10:00 am (Eastern). Interested parties are invited to participate in the call by dialing 877-407-9210 (toll free domestic) or 201-689-8049 (International) or via webcast http://www.investorcalendar.com/event/29196.
"Abeona has made significant progress across multiple fronts, including various regulatory achievements, additional enrollments in our MPS IIIA trial, and the reporting of encouraging initial results for our MPS IIIB trial," stated Carsten Thiel, Ph.D., Abeona's CEO. "Notably, both our lead clinical programs, EB-101 and ABO-102, were recently granted RMAT designation by the FDA, supporting the strong safety and biopotency evidence from these programs, and their potential to address the unmet medical need for RDEB and MPS IIIA patients."
1st Quarter Summary Financial Results:
- Cash position: Cash and cash equivalents as of March 31, 2018 were $132 million, compared to $137.8 million as of December 31, 2017.
- Revenues: Revenues were $2.6 million for the first quarter of 2018, compared to $186 thousand in the first quarter of 2017. A large portion of the increased quarterly revenues consisted of the recognition of Foundation grants that were announced during the 4th quarter of 2017. A portion of the grants were received in the 4th quarter of 2017 and in the 1st quarter of 2018, and the amount recognized is matched against corresponding expenditures for drug manufacture and clinical readiness. Additional revenues consisted of royalties from marketed products, specifically MuGard. In the quarter, Abeona adopted ASC 606 pertaining to revenue recognition, and therefore there will no longer be any recognition of deferred revenues related to upfront payments from earlier license agreements.
- Loss per share: Loss per share was $0.18 for the first quarter of 2018, compared to a loss per share of $0.13 in the comparable period in 2017.
Abeona Recent Highlights:
April 23, 2018: Announced FDA Grants RMAT Designation to ABO-102 Gene Therapy in MPS IIIA
April 20, 2018: Announced EMA Grants Orphan Drug Designation in the European Union for ABO-202 Gene Therapy Program in Batten Disease
April 2, 2018: Announced Appointment of Carsten Thiel, Ph.D., as Chief Executive Officer
March 15, 2018: Announced FDA Grants Rare Pediatric Disease Designation for ABO-202 Gene Therapy Program in CLN1 Disease
February 12, 2018: Announced FDA Grants Orphan Drug Designation for ABO-202 Gene Therapy Program in Infantile Batten Disease
February 8, 2018: Reported Top-Line Data from Phase 1/2 Gene Therapy Trial in MPS IIIA
-- ABO-102 results presented at WORLDSymposium for Lysosomal Diseases show significant time- and dose-dependent reduction of underlying disease pathology, including decreased CSF and urine GAGs (HS fragments) and diminished liver volumes
-- Evidence of cognitive benefit at six months post treatment in Cohort 2 and at one year in Cohort 1
-- Company receives FDA allowance to lower enrollment age to six months
February 7, 2018: Reported on Initial Safety and Biopotency Signals in MPS IIIB Gene Therapy Clinical Trial
-- ABO-101 is well tolerated and demonstrates early biopotency signals with significant disease-specific heparan sulfate (HS) reductions in cerebral spinal fluid, urine, and plasma and greater than 300-fold increase in NAGLU enzyme activity observed in first subject at 30 days post injection
January 29, 2018: Announced FDA Grants Regenerative Medicine Advanced Therapy Designation for EB-101 Gene Therapy in Epidermolysis Bullosa
"2018 continues to be a year of execution for Abeona. With the expanded leadership, we look to a number of milestones in the year including the commencement of our pivotal Phase 3 trial in EB, the completion of enrollment in our Phase 1/2 trial in MPS IIIA, and significant progress on our in-house GMP manufacturing facility," stated Steven H. Rouhandeh, Abeona's Executive Chairman. "With the team focusing their efforts and leading the charge on clinical development, we look forward to our continued dialogue with the regulatory bodies and advancing our gene therapies to rare disease patients."
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 EB-101 (gene-corrected skin grafts) for recessive dystrophic epidermolysis bullosa (RDEB), ABO-102 (AAV-SGSH), an adeno-associated virus (AAV) based gene therapy for Sanfilippo syndrome type A (MPS IIIA) and ABO-101 (AAV-NAGLU), an adeno-associated virus (AAV) based gene therapy for Sanfilippo syndrome type B (MPS IIIB). Abeona is also developing ABO-201 (AAV-CLN3) gene therapy for CLN3 disease, ABO-202 (AAV-CLN1) for treatment of CLN1 disease, 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.
SVP, Finance & Investor Relations
Abeona Therapeutics Inc.
+1 (646) 813-4707
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 Section 21E of the Securities Exchange Act of 1934, 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; our expectation to commence our pivotal Phase3 trial in EB; 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; the completion of enrollment in our Phase 1/2 trial in MPS IIIA; we have recently initiated enrollment in our MPS IIIB program; our expectation that we will continue to advance our gene therapy for MPS IIIA patients; and our goal of achieving significant progress on our in-house GMP manufacturing facility. 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
One Liberty Plaza - 165 Broadway
NY 10006 New York
GlobeNewswire is one of the world's largest newswire distribution networks, specializing in the delivery of corporate press releases financial disclosures and multimedia content to the media, investment community, individual investors and the general public.
Følg saker fra GlobeNewswire
Registrer deg med din epostadresse under for å få de nyeste sakene fra GlobeNewswire på epost fortløpende. Du kan melde deg av når som helst.
Siste saker fra GlobeNewswire
PubMatic Launches OpenBid, Bringing Full Strength of Programmatic Monetization to the Mobile App Environment21.2.2019 15:00:00 | Pressemelding
The Programmatic-First SDK Offers App Developers Benefits of Header Bidding REDWOOD CITY, Calif., Feb. 21, 2019 (GLOBE NEWSWIRE) -- PubMatic, the publisher-focused sell-side platform (SSP) for an open digital media future, today announced the launch of OpenBid, a breakthrough programmatic-first solution that provides app publishers and developers with a gateway to programmatic demand and brand ad budgets. Consumers globally are increasingly interacting with media via mobile devices, and many brand advertisers are turning to in-app advertising to reach this highly-engaged audience. Many are focusing their budgets on automated buying channels such as the open exchange and private marketplaces, with over 90 percent of global media buyers planning to increase their programmatic direct in-app budgets in 2019 (Forrester Consulting). However, many app developers have been unable to fully capitalize on the growing interest from brand advertisers as they rely on legacy mobile mediation partners
Intrinsyc Announces Immediate Availability of Premium-Tier System on Module based on Qualcomm Technologies’ SDA83521.2.2019 13:30:00 | Pressemelding
Designed for use in XR Applications, IP Cameras, Enterprise Tablets, Medical Imaging, and other Next-Generation IoT Devices VANCOUVER, British Columbia, Feb. 21, 2019 (GLOBE NEWSWIRE) -- Intrinsyc Technologies Corporation (TSX: ITC and OTCQX: ISYRF) (“Intrinsyc” or the “Company”), a leading provider of solutions for the development and production of embedded and Internet of Things (IoT) products, today announced the availability of the Open-Q™ 835 µSOM (micro System on Module) and Development Kit. Intrinsyc’s Open-Q™ 835 µSOM is an ultra-compact (50mm x 25mm) production-ready embedded computing module that is ideal for powering premium performance IoT devices. It is powered by the Qualcomm® SDA835 system on chip (SoC) from Qualcomm Technologies, Inc. “Intrinsyc’s Open-Q™ 835 µSOM is Intrinsyc’s most advanced embedded computing module; enabling the highest combination of computing performance, thermal efficiency and power optimization,” said Cliff Morton, Vice President, Solutions Engin
IMImobile releases unified RCS Messaging API to accelerate RCS adoption for enterprise customer communications21.2.2019 11:09:00 | Pressemelding
Unified RCS Messaging API and low-code toolset available in IMImobile’s enterprise cloud communications platform IMIconnect will enable businesses to launch RCS customer journeys up to 10 times faster LONDON, Feb. 21, 2019 (GLOBE NEWSWIRE) -- Global cloud communications software and solutions provider IMImobile PLC, today releases a unified RCS Messaging API alongside its low-code toolset, in its enterprise cloud communications platform, IMIconnect, to drive the adoption of RCS business messaging by leading enterprises globally. Rich Communication Service (RCS) has been widely anticipated as the evolution for SMS messaging to deliver rich customer experiences to today’s digitally savvy consumers. According to Mobilesquared, there will be 1.01bn people using RCS messaging across 168 mobile operators globally by the end of 2019. This is expected to grow to 3.23bn across 486 mobile operators by the end of 2023.1 With the release of its unified RCS API in the IMIconnect platform, enterpris
Tenaris Announces 2018 Fourth Quarter and Annual Results20.2.2019 22:29:00 | Pressemelding
The financial and operational information contained in this press release is based on audited consolidated financial statements presented in U.S. dollars and prepared in accordance with International Financial Reporting Standards as issued by the International Accounting Standard Board and adopted by the European Union, or IFRS. Additionally, this press release includes non-IFRS alternative performance measures i.e., EBITDA, Net cash / debt and Free Cash Flow. See exhibit I for more details on these alternative performance measures. LUXEMBOURG, Feb. 20, 2019 (GLOBE NEWSWIRE) -- Tenaris S.A. (NYSE, Buenos Aires and Mexico: TS and MTA Italy: TEN) (“Tenaris”) today announced its results for the fourth quarter and year ended December 31, 2018 with comparison to its results for the fourth quarter and year ended December 31, 2017. Summary of 2018 Fourth Quarter Results (Comparison with third quarter of 2018 and fourth quarter of 2017) 4Q 2018 3Q 2018 4Q 2017 Net sales ($ million) 2,105 1,899
New Samsung Galaxy Ultrasonic Fingerprint System World’s First to Achieve FIDO Biometric Certification20.2.2019 21:30:00 | Pressemelding
Samsung’s new “in-display” Ultrasonic Fingerprint system certified by FIDO Alliance as meeting globally recognized standards for biometric recognition performance and Presentation Attack Detection (PAD) MOUNTAIN VIEW, Calif., Feb. 20, 2019 (GLOBE NEWSWIRE) -- The FIDO Alliance announced today that the Samsung Galaxy S10 and S10+ smartphones are the first products to feature certification from the FIDO Alliance’s new Biometric Component Certification Program. This certification validates that the new in-display fingerprint recognition system meets industry standards for user verification and detecting presentation (or “spoof”) attacks. “As mobile devices increasingly become our primary means of storing sensitive information and conducting critical transactions, the industry leaders in FIDO Alliance have determined the market needs a standard-based means to assess the efficacy of biometric certification components -- which is why we recently launched our Biometric Component Certification
Infovista Expands 5G Network Testing and Planning Capabilities20.2.2019 15:00:00 | Pressemelding
ASHBURN, Va., Feb. 20, 2019 (GLOBE NEWSWIRE) -- Infovista, the leader in modern network performance, today announced new versions of its TEMS Investigation and Planet solutions. With this announcement, Infovista is the only vendor offering the complete 5G portfolio comprising full network planning and testing in a single, integrated platform. Infovista is now uniquely positioned to help mobile network operators roll out 5G NR networks by including the ability to provide integrated Geodata, 5G Planning and Network Testing capabilities. Tweet This: @Infovista expands 5G network testing and planning capabilities, offering complete 5G portfolio in a single, integrated platform: https://bit.ly/2Nm8Rup With the new release of TEMS Investigation, Infovista introduces support for 5G smartphones based on the Qualcomm X50 chipset. With initial support of Qualcomm based devices and plans for agnostic device support, customers will be able to choose between different test devices and scanners to s