Abeona Therapeutics Inc (NASDAQ: ABEO)
Still under the radar, ABEO appears to have put the pieces in place to ramp up its presence in 2017. Regardless of the recent misinformation that has plagued the market and confused investors, there is one thing that investors can rely on 100% of the time….the fact that the FDA has been presented accurate and timely data and that oversight in trial design and implementation is intense. Importantly, and to this point, investors need to rely on company sponsored data, instead of the misplaced and intentionally misleading rhetoric being published through editorial websites.
ABEO- An Early Start In 2017
Abeona has already been active in 2017, presenting at the JP Morgan investor conference during the early part of January. Management is clearly setting the stage for potential milestones to be delivered as early as the end of February 2017, when the company is planning to release additional data from its ABO-102 phase I/II study.
ABEO investors should pay attention to the scheduled February 16th WORLDSymposium conference, where management is planning to release data on two of three patients currently enrolled in the low dose cohort of the ABO-102 trial. The company is expected to release neurocognitive data from each patient, which if positive, may lead ABEO to initiate discussions with the FDA to designate breakthrough designation for the therapy. Additionally, ABEO may be in a position to further ask the FDA to grant a registration trial and begin the process of designing a mutually agreeable trial design.
ABEO is planning to discuss both options prior to the end of February 2017, perhaps an early indication of company confidence.
Investors can expect some material updates at the February 16th WORLDSymposium conference. ABEO is expected to release important data related to the ABO-102 trial, specifically, 90-day and six month data from patients treated in the low dose cohort of the MPS IIIA trial. Updates on the neurological data from all three patients are expected, with a focus on at least one of the patients being treated in the high dose cohort.
Consistent with past discussions, management continues to remain confident that neurological improvement may potentially be observed in the six month follow-up, and equally as important, expects to show additional improvement in urinary GAG reductions.
The expected data release may serve as milestone moments for ABEO, and investors would be wise to pay close attention to both the conference and the data.
Bring On The Facts
Paying close attention to the near term events, with material releases expected expected within the next 30-days, ABEO may be on the verge of delivering data that can be a transformative step forward for the company. Already demonstrating unparallelled results in Sanfilippo patients, ABEO can take the next step to quiet the critics of this potentially breakthrough therapy and seize an extremely lucrative Sanfilippo market. Although the market in terms of addressable patients is small, the financial benefit from a viable therapy is not, with expectations that an approved treatment will bring an enterprise value well in excess of a billion dollars.
With over $70MM in cash and virtually no debt, ABEO is extremely well fortified financially, as the company expects to burn less than $3MM dollars per quarter.
Gene therapy is grabbing the attention of investors, and ABEO has more than its fair share of well established institutional investors believing in their science, some holding in excess of 5% of the company stock. With promising data expected, investors may be wise to pay attention to actual company data, paying less focus toward disclosed short sellers that have an agenda to spew confusing and intentionally misleading information about the company.
Analyst price targets average in the range of $12.00 per share, and if ABEO can deliver some meaningful and durable results in the middle of February, these targets may be quickly met and revised higher. Without a doubt, the next 30-days for ABEO investors may prove to be a nail biter, however, with the company already focusing upon potential dialogue with the FDA regarding BT designation, reading between the lines might not be a bad way to gauge the likelihood of positive trial results.
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