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Abeona Therapeutics (ABEO)

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Last Post: 11/1/2016 4:08:46 PM - Followers: 51 - Board type: Free - Posts Today: 0


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Abeona Therapeutics Announces Fourth Quarter and Full Year 2015 Summary Financial Results and Recent Operational Highlights

NEW YORK, NY and CLEVELAND, OH -- (Marketwired) -- 03/08/16 --  Abeona Therapeutics, Inc. (NASDAQ: ABEO), a biopharmaceutical company focused on developing and delivering gene therapy and plasma-based products for severe and life-threatening rare diseases, today announced summary financial results for the fourth quarter and full fiscal year ended December 31, 2015. The Company will provide a business update for investors and other stakeholders on a conference call, Wednesday, March 9th, at 4:45 pm (Eastern). Tim Miller, Ph.D., President and CEO and Jeffrey Davis, Chief Operating Officer, together with other executives, will conduct the call. Interested parties are invited to participate in the call by dialing 877-269-7756 (toll free domestic) or 201-689-7817 (international). The call will consist of an overview of the Company's 4Q15 financials, and a discussion of business highlights.

"The past year has led to significant advancements in our goal of building a leadership position in the field of gene therapy and plasma protein therapies towards transforming the lives of patients with rare diseases," stated Steven H. Rouhandeh, Executive Chairman. "In 2015, we expanded our pipeline with two clinical stage AAV gene therapies for Sanfilippo syndrome types A and B, added a third AAV gene therapy product in Juvenile Neuronal Ceroid Lipofuscinosis (JNCL) (also known as juvenile Batten disease), signed a license to an innovative CRISPR-Cas9 gene editing platform in rare blood disorders, with an initial focus in Fanconi anemia, strengthened our team, and added substantial financial resources to our balance sheet. In 2016, our priorities include driving our AAV gene therapy and alpha-1 protease inhibitor programs into the clinic, and advancing our gene editing programs including defining of regulatory pathways to bring our CRISPR product candidates to patients."

Tim Miller, Ph.D., President and CEO, stated, "2016 will be an exciting, transformative year for Abeona Therapeutics as we position ourselves to enter multiple human clinical trials with our pipeline of innovative product candidates. As recently announced, the FDA allowance of the IND for the Phase 1/2 clinical study of ABO-102 for patients with Sanfilippo syndrome type A (MPS IIIA) moves our programs into the clinic here in the US, and we look forward to working with our collaborators to expand this program into Europe and Australia later this year. We believe that our gene therapy programs in Sanfilippo syndrome type B (ABO-101) and Juvenile Neuronal Ceroid Lipofuscinosis (ABO-201) will follow shortly. Lastly, we would like to thank our dedicated researchers and clinical collaborators, as well as the many dedicated patient foundations, for their tireless efforts and commitment to advancing new treatment options for these devastating unmet medical needs."

Recent Abeona Highlights

  • Sanfilippo syndrome gene therapy programs: On February 29, 2016, Abeona announced the FDA allowance of an Investigational New Drug (IND) for systemic AAV Phase 1/2 clinical study with ABO-102 gene therapy for patients with Sanfilippo syndrome type A (MPS IIIA). On January 11, 2016, we announced that initial regulatory approvals from European bodies -- the Genetically Modified Organism (GMO) Voluntary Release regulatory filings, and the ethical committee regulatory filings -- for both the ABO-101 and ABO-102 programs in Spain. Abeona plans to commence both programs for the upcoming human clinical trials to be conducted at Cruces University Hospital in Bilbao, Spain. Both the ABO-101 and ABO-102 programs have received Orphan Drug and Pediatric Rare Disease designations from the FDA.
    SDF-Alpha plasma protein program: Abeona has completed optimization of the downstream chromatography steps for our SDF-Alpha™ (alpha-1 protease inhibitor) for inherited COPD. Additional provisional patent applications have been filed to provide the Company with expanded intellectual property protection. The Company has expanded its CMO relationships to ensure it has the ability to manufacture clinical material for future trials. The Company confirms that its proprietary SDF platform provides significantly enhanced yields of alpha-1 protease inhibitor, at levels up to 10 times of that achievable with the industry standard Cohn processes, and with purity levels consistent with that achieved by other commercial processes.
    Advanced pipeline programs: Together with its academic collaborators, the Company continued to progress its pre-clinical programs in juvenile Batten disease and its CRISPR-Cas9 program in Fanconi anemia (FA) and other rare blood disorders. Juvenile Batten disease is the most common form of a group of disorders known as neuronal ceriod lipofuscinosis (NCL), a lysosomal storage disease that affects the nervous system in children and for which there are no approved treatment options. Fanconi anemia is a rare pediatric blood disease characterized by multiple physical abnormalities, bone marrow failure and a higher than normal risk of cancer. 
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Bid Ask Day's Range
ABEO News: Post-effective Amendment to Registration Statement (pos Am) 04/25/2017 04:17:17 PM
ABEO News: Abeona Therapeutics Announces EB-101 Clinical Update to be Presented at the Society for Investigative Dermatology Annual Meet... 04/25/2017 08:05:00 AM
ABEO News: Abeona to Present At Multiple Upcoming Conferences 04/20/2017 08:05:00 AM
ABEO News: Proxy Statement (definitive) (def 14a) 04/11/2017 06:03:03 AM
ABEO News: Abeona Announces Rare Disease Gene Therapy Symposium with the New York Academy of Sciences 04/05/2017 07:43:00 AM
News News Alert: Post-effective Amendment to Registration Statement (pos Am) 04/25/2017 04:17:17 PM
#1143   Abeo closes offering @ $7.00 Roofer73 11/01/16 04:08:46 PM
#1142   6 million shares @ $7.00 is the offering Roofer73 10/27/16 09:20:57 AM
#1141   Isn't size and price of an offering a Roofer73 10/26/16 05:13:59 PM
#1140   no i'm sitting with free shares...i'm good Bob Stocks 10/20/16 08:44:39 PM
#1139   Oops! Glider549 10/18/16 12:38:00 PM
#1138   ABEO bullish 6.86 stocktrademan 10/10/16 05:00:49 PM
#1137   ABEO bullish 6.8223 stocktrademan 10/07/16 11:58:52 AM
#1136   I wouldnt say "no posts" ;) longhorn4lif 10/01/16 11:23:46 AM
#1135   I sold half also Bob Stocks 09/23/16 06:07:37 PM
#1134   Just sold half my position, sort of as SmallCapsMarket 09/20/16 02:38:43 PM
#1133   NICE Bob Stocks 09/20/16 12:27:49 PM
#1132   She doesn't act as if she wants to SmallCapsMarket 09/20/16 09:56:19 AM
#1131   Check out the article SeekingAlpha put out today 9/16/2016 Glider549 09/16/16 03:14:58 PM
#1130   Doubled since July...and no posts Bob Stocks 09/15/16 09:59:04 PM
#1129   $5 AH. Very nice..... SmallCapsMarket 09/07/16 05:05:48 PM
#1128   Great long term play here but 4.30 is longhorn4lif 08/19/16 12:11:59 PM
#1127   Still pretty low volume....seems under radar still to me! longhorn4lif 08/17/16 07:36:07 PM
#1126   It's noticed. It's just not being commented on...... SmallCapsMarket 08/17/16 09:34:33 AM
#1125   $4 today stil nobody notices wow longhorn4lif 08/16/16 10:40:58 PM
#1124   took a little longer then I thought to longhorn4lif 08/04/16 07:05:09 PM
#1123   still nobody like this play. Another long longhorn4lif 08/04/16 07:04:03 PM
#1122   Nobody found you yet? Dont worry your longhorn4lif 06/01/16 05:25:29 PM
#1121   ready now longhorn4lif 04/23/16 12:29:19 AM
#1120   Lonely and forgotten for now.....dont worry nobody wants longhorn4lif 04/14/16 10:14:50 AM
#1119   3.50 by next week longhorn4lif 04/13/16 11:04:51 PM
#1118   Will run big soon just needs to be found longhorn4lif 04/12/16 11:31:52 PM
#1117   Way under radar longhorn4lif 04/12/16 11:30:46 PM
#1116   Running! longhorn4lif 04/04/16 12:09:40 PM
#1115   Nobody seems to like this.....great time to buy! longhorn4lif 04/03/16 10:26:57 AM
#1114   ABEO: Gene edit investors on ABEO today. 4/1/2016 remind2 04/01/16 02:44:29 PM
#1113   Abeona Therapeutics Secures Key Regulatory Approvals for Clinical venturecapp 01/14/16 12:31:20 PM
#1112   $ABEO recent news/filings stocktrademan 12/01/15 04:40:21 PM
#1111   me too, got 2.5 k at 4.15, just stockdawg44 08/24/15 10:26:26 AM
#1110   I was able to get 3K @ $4.18 SmallCapsMarket 08/24/15 10:12:56 AM
#1109   Looking good here, again! stockdawg44 07/29/15 12:50:05 PM
#1108   ABEO stronger on news today. With some volume nokomis 07/28/15 12:49:27 PM
#1107   ABEO. Soros and another increasing stake. Bullish 9:04 nokomis 07/28/15 11:23:44 AM
#1106   ABEO. agree, but could be another two weeks nokomis 07/23/15 03:34:22 AM
#1105   ABEO (formerly PTBI) High time George Soros increased nokomis 07/21/15 08:00:26 PM
#1104   $AEBO – nice close above the 200 DMA ospreyeye 07/13/15 06:04:59 PM
#1103   ABEO....Moving right back up. Bit of a squeeze stockdawg44 07/10/15 03:29:03 PM
#1102   Yes Brock69 07/06/15 09:19:40 AM
#1101   This was PTBI? SwingTradeProdigy 07/06/15 12:49:53 AM
#1100   My $8.00 per share I bought in at Brock69 06/30/15 10:26:41 AM
#1099   Nice job mods, Wildbilly 06/23/15 03:40:49 PM
#1098   PlasmaTech Biopharmaceuticals Announces Name Change to Abeona Therapeutics lasers 06/22/15 07:00:04 AM
#1097   NEWS POSTED ON SCOTTRADE Roth Capital initiated coverage Brock69 06/11/15 10:22:09 AM
#1096   Really that's why it's up. I dont see mike007 06/11/15 10:06:28 AM
#1095   Showing on Scottrade via Dow Jones News scotsand 06/11/15 10:03:15 AM
#1094   Roth initiated coverage of the company with a stockdawg44 06/11/15 09:46:14 AM