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
Följ NASDAQ OMX
Abonnera på våra pressmeddelanden.
Senaste pressmeddelandena från NASDAQ OMX
eGain Enables Conversational Customer Service Through Apple Business Chat20.7.2018 12:30 | Pressmeddelande
SUNNYVALE, Calif. and NEWBURY, United Kingdom, July 20, 2018 (GLOBE NEWSWIRE) -- eGain (NASDAQ:EGAN), the leading provider of cloud-based customer engagement solutions, today announced its integration with Apple Business Chat. According to Gartner, requests for customer support through consumer mobile messaging apps will exceed requests for customer support through traditional social media by 2019*. Moreover, 56% of consumers surveyed in a Nielsen study would rather message a business than call customer service, and 67% expect to message businesses even more over the next two years. Key capabilities Among key capabilities of the integrated solution are: Enabling hundreds of millions of consumers on iPhone and iPad to interact with businesses through the Messages app Leverage eGain AI to infer customer intent, power bot conversations through messaging, route escalations to contact center agents, and guide agents through messaging conversations Provide immersive customer experiences with
Marcus Hiles - Texas Takes #1 Four Years in a Row in America's Top States for Business19.7.2018 23:39 | Pressmeddelande
DALLAS, July 19, 2018 (GLOBE NEWSWIRE) -- The future business scene in Texas is looking brighter than ever as the state continues to hold its place as a national leader. Growth is spreading across areas such as North Texas, Houston and San Antonio with businesses quickly expanding their operations in the state that offers some of the best in business-friendly climates and overall growth potential. Tapping into the market recently are global leaders such as Toyota, Liberty Mutual and JP Morgan who have taken advantage of the state's increasing network of commercial properties, workforce and business resources. Named by CNBC for the fourth consecutive year as America's Top State for Business, Texas scored above all 50 states on overall business competitiveness. With the business hub building on its role as a national leader for the past decade, this top rank title reflects the progress Texas has made in cementing its place in the global economy. "This national recognition comes without s
Second Quarter 2018 Results Conference Call19.7.2018 21:34 | Pressmeddelande
AURORA, Ontario, July 19, 2018 (GLOBE NEWSWIRE) -- Magna International Inc. (TSX:MG) (NYSE:MGA) SECOND QUARTER 2018 RESULTS CONFERENCE CALL WEDNESDAY - AUGUST 8th, 2018 7:30 AM ET DIAL IN NUMBERS North America Toll Free: International Toll: Webcast: 1-888-223-4641 1-416-981-9080 www.magna.com Slide presentation will be available on our website prior to the call. REBROADCAST INFORMATION Replay available 2 hours after the call until August 15, 2018 North America Toll Free: International Toll: Reservation No.: 1-800-558-5253 1-416-626-4100 21892829 INVESTOR CONTACT Louis Tonelli, Vice-President, Investor Relations email@example.com, 905-726-7035 TELECONFERENCE CONTACT Nancy Hansford, Executive Assistant, Investor Relations firstname.lastname@example.org, 905-726-7108 This announcement is distributed by Nasdaq Corporate Solutions on behalf of Nasdaq Corporate Solutions clients. The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originali
Uganda National Airlines Company Limited Signs Firm Order for Four Bombardier CRJ900 Aircraft19.7.2018 18:36 | Pressmeddelande
First operator of the new CRJ Series ATMOSPHÈRE cabin in Africa MONTREAL, July 18, 2018 (GLOBE NEWSWIRE) -- Bombardier Commercial Aircraft announced today that it has signed a firm order for four new CRJ900 regional jets with Uganda National Airlines Company. Based on the list price for the CRJ900 aircraft, the firm order is valued at approximately US$190 million. "We congratulate the Government of Uganda for the revival of its national flag carrier, and are thrilled that the new airline has selected Bombardier and the CRJ900 regional jets for its upcoming debut," said Jean-Paul Boutibou, Vice President, Sales, Middle-East and Africa, Bombardier Commercial Aircraft. "Recognized for its superior economics and efficiency, the CRJ Series aircraft have enabled airlines worldwide to serve communities with better connectivity, and we look forward to supporting the development of Uganda's regional air travel with these CRJ900 regional jets." Uganda Airlines will operate the CRJ900 in dual-cla
CrownBio Supports Excellence in Translational Research with Grant Award that Funds Innovative PDX Model Development in Immuno-Oncology19.7.2018 15:03 | Pressmeddelande
"Cancer Research Center of Lyon iPS novel PDX models formulate new immune cell focused strategies" SAN DIEGO, July 19, 2018 (GLOBE NEWSWIRE) -- Crown Bioscience, a global drug discovery and development services company providing translational platforms to advance oncology, inflammation, cardiovascular and metabolic disease research, is proud to announce the award of its Patient-Derived Xenograft (PDX) grant program to doctors Fabrice Lavial, Christophe Caux and Bertrand Dubois from the Cancer Research Center of Lyon (CRCL). The grant program was established to support oncology researchers pursuing scientific advancements in cancer using PDX technology. Following an extensive review, CrownBio's Scientific Steering Committee selected Dr. Lavial and his colleagues at the CRCL due to their project's potential to create breakthroughs in preclinical oncology strategies. Their research combines PDX and iPS cell technologies to create patient-specific, humanized models. These unique models wil
Jumio Introduces Liveness Detection for Web to Better Deter Fraud During Account Onboarding19.7.2018 14:00 | Pressmeddelande
New identity proofing functionality ensures that the person behind a Web upload verification is present and the person actually creating a new online account PALO ALTO, Calif., July 19, 2018 (GLOBE NEWSWIRE) -- Jumio, the creator of Netverify(TM) Trusted Identity as a Service (TIaaS), today announced the addition of Liveness Detection for Web to better thwart fraudsters' evolving and sophisticated attempts to assume another individual's identity. With identity verification, Jumio's approach is to first verify the government-issued ID (e.g., driver's license, passport or ID card) and ensure that it is authentic and has not been doctored. For mobile SDK customers, Jumio then requires the user to take a selfie which enables the company to compare the person in the selfie to the person pictured in the ID document. Since Netverify is an omnichannel solution, Jumio also supports identity verification via desktop webcams. This channel enables our customers to reach large market segments who a
I vårt pressrum kan du läsa de senaste pressmeddelandena, få tillgång till pressmaterial och hitta kontaktinformation.Besök vårt pressrum