Replies to post #374 on Ohr Pharmaceutical, Inc. (OHRP)

[drbio45]

Yasmeen Rahimi, Ph.D., [e-mail]
[phone]
Sales [phone], Trading [phone]


COMPANY NOTE | EQUITY RESEARCH | November 28, 2017


Healthcare: Biotechnology
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Ohr Pharmaceutical, Inc. | OHRP - $0.86 - NASDAQ | Buy
Company Update

Stock Data

52-Week Low - High
$0.56 - $2.90
Shares Out. (mil)
56.21
Mkt. Cap.(mil)
$48.3
3-Mo. Avg. Vol.
278,859
12-Mo.Price Target
$7.00
Cash (mil)
$18.1
Tot. Debt (mil)
$0.1


OHRP: Squalamine Remains Strong Wet-AMD Combo Player; Affirm Buy

With the announcement from Regeneron Pharmaceuticals (REGN-NC) yesterday that it will discontinue development of its REGN910 and Eylea combination therapy, we become more confident in the potential of squalamine. Squalamine is an easy to use non-invasive eye drop and has a novel mechanism of action that helps address a subgroup of patients largely ignored by anti-VEGF therapy alone. With that said, we affirm our Buy rating of OHRP.


Another combo trial bites the dust. Yesterday, Regeneron Pharmaceuticals Inc. (REGN-NC) announced its discontinuation of REGN910, an angiopoetin-2 antibody implicated in tumor and vascular endothelial anti-angiogenesis, and Eylea combo therapy for the treatment of diabetic macular edema (DME) and wet AMD. REGN explained it did not exhibit convincing efficacy over Eylea monotherapy in two Phase 2 trials, ONYX and RUBY. ONYX was a 365 wet-AMD subject trial and RUBY was a 304 DME subject trial, both testing for visual acuity baseline change measured by ETDRS score at 12 weeks. While the company did not reveal trial result details, it announced it will present them at an upcoming medical conference.
Squalamine: Non-invasive with novel MOA. Recall that the predominant method to treat wet AMD currently is anti VEGF-A, a monoclonal antibody that inhibits anti-vascular endothelial growth factor (VEGF). In our view, anti-VEGF therapy can carry significant burden because: it requires monthly injections, involving a regulated schedule difficult for both patients and physicians to maintain; it can be financially burdensome; and patients with occult CNV are often resistant to anti-VEGF. In our opinion, squalamine by OHRP, intended as a combination therapy with anti-VEGF injections, addresses these points. It is a simple non-invasive eye drop that can help reduce the number of required doctor visits by increasing treatment efficacy per visit, and it has shown most profound benefits in occult CNV <10mm2 patients. Squalamine has a novel MOA upstream of the VEGF pathway and modulates anti-angiogenic activity intra- and extra-cellularly by calmodulin-binding. Thus, Squalamine plus anti-VEGF presents a two-pronged approach to better address the subgroup of patients largely left out with anti-VEGF therapy alone.
Key binary event is MAKO Phase 3 top-line results in early January. OHRP's Phase 3 MAKO study tests for squalamine and Lucentis combo therapy in 200 wet-AMD subjects. Primary endpoint is BCVA at nine months in classic or occult CNV <10mm2. We believe the results will be positive, due to the strategic identification of the patient subgroup most likely to gain greatest therapeutic advantages, based upon its Phase 2 results.