Biotech Values

[FreeNorth]

GNRO.PA:
LifeSci Capital released a report on GeNeuro SA (GNRO.PA), which recently had an IPO. See the full report. The material for this post was obtained from LSC's report and from the company's web site.

The company is developing treatments for neurological disorders and autoimmune diseases, such as multiple sclerosis, by neutralizing putative causal factors that are encoded by human endogenous retroviruses (HERV). MSRV-Env is an HERV genetic element that is normally unexpressed in people but often expressed in multiple sclerosis (MS). GNRO's first product, GNbAC1, is a monoclonal antibody against this protein. GNRO "reported positive data from a P2a trial that tested the safety, tolerability, and pharmacokinetics of GNbAC1 in 10 MS patients. GNbAC1 was found to be safe and well-tolerated and showed no signs of immunogenicity or broad immunosuppression. In addition, although the sample size in this study was small, the trial did show a slowing of disability progression" (LSC's report).

GNRO has a partnership with Servier that covers the use of GNbAC1 to treat MS. Servier is providing €37.5 million ($42.4 million) to finance the Phase IIb trial and has an option to license GNbAC1 after the trial's completion. Following the exercise of this option, Servier would cover the cost of Phase III development. GNRO has full rights in the US, which represents about two-thirds of the MS market, as well as Japan. GNRO also has full rights to develop GNbAC1 in other indications, and Servier has right of first negotiation within its territories. GNRO can receive up to €325 million ($366 million) in development and sales milestone payments as well as tiered royalties.

IPO on 14 April 2016 netted €29.4 M from 2,538,500 shares sold @ €13.00

July 18 GNRO reported cash and revenue for Q2 2016
- Cash: €42.4 million at 30 June 2016
- Revenue: €2.5 million in Q2

Upcoming events:
- Presentation at Rodman & Renshaw’s 18th Annual Healthcare Conference, September 11 to 13 in New York.
- First half 2016 results: Thursday 29 September 2016 (after trading hours)

near-term milestones
- H2 2016 – start P2a POC for GNbAC1 in type 1 diabetes.
- 2017 – Completion of enrolment for P2b in MS.
- Q4 2017 – Preliminary results from CHANGE MS P2b in RRMS.

Comment: The MSRV-Env hypothesis for MS is reminiscent of the amyloid hypothesis for Alzheimer's: correlation might mean causation. Trials, however, might be easier for GNRO.

Disclosure: I have no position and no plan to start one this year. And I have no connection with LSC or GNRO.