Gracias Framus

«ANTH – 2016 – Be Ready For B-Mod and Sollpura
A meeting with CEO Paul Truex at JPM in San Francisco keeps our positive stance intact, and then some. The Company is well on its way to completing four important clinical trials, with trial data projected to be released in each of the next four quarters. In chronological order:

1. Q2: B-mod in IgAN – Top-line data, with the primary endpoint of reduction in proteinurea, is expected to be released in the second quarter. While IgAN is not in consensus models due to the end of the Zenyaku deal (officially ended on 1/7), the Company will report on the Phase II/III trial with ~50 patients. Importantly, proteinurea makes up four points on the lupus SRI-6 scale that is the primary
endpooint of CHABLIS-1/7.5 trials, in our view, a significant reduction in this marker will bode well for the lupus studies. Since this endpoint was highly significant in the PEARL trials, we believe this may represent the low hanging fruit for ANTH’s first clinical data release in three years. Hence, proteinurea/development in IgAN may provide upside surprise earlier in 2016 than the lupus/Sollpura
trials. Following the release, ANTH may be able to form a) a much larger Japanese partnership than the Zenyaku deal or b) a larger global deal for marketing b-mod.

2. Q3: CHABLIS-SC1 – Data from the recent ACR meeting continues to support b-mod’s clinical trial design in the advanced SLE population. Recent GSK results (Stohl, A., ACR, 2015) showed SELENA-SLEDAI score (≥6, ≥8, ≥10) correlated with the highest
Benlysta response in the “CHABLIS population” (% responder delta between Benlysta and placebo: +11.8%, +12.4%, and +15.2%) CHABLIS-SC1/CHABLIS7.5 are enrolling SELENA-SLEDAI ≥10 pts. Therefore, optimism is rising in favor of the blisibimod trials
(same mechanism of action as Benlysta but more potent and 1/week sub q). As mentioned above, the proteinurea endpoint of IgAN will make up four of the six symptom improvements in SRI-6 needed for a positive CHABLIS-SC1 outcome. Data are expected inQ3:16.

3. Q4:16/Q1:17 – SOLUTION/SIMPLICITY– SOLUTION and SIMPLICITYtrials are moving along schedule. Phase III trials in EPI – children and adult exocrine pancreatic insufficiency (EPI) patients –cystic fibrosis (CF), respectively, are due to be released in Q4:16/Q1:17.

At our meeting, management indicated that the Sollpura label could include “all EPI” vs. strictly cystic fibrosis-EPI. Management may therefore add 20-30 patients with EPI from chronic pancreatitis (CP) data (which was also positively generated by licensor Eli Lilly). Timelines would not be affected, but the granting of a wider Sollpura label would no question be positive. Manufacturing is also
progressing nicely, with pill formulations of 10K/40K/80K lipase units being rolled out initially depending on the dose optimization data from SOLUTION. SIMPLICITY, the small Phase III trial for children (n=~30) given Sollpura in powder form/saches, is also due to begin in Q2. ANTH is working preclinically on a possible celiac disease version of Sollpura.

With a market cap of just $120 million, ANTH remains one of the most undervalued Phase III biotech stocks around with not one but two de-risked compounds completing Phase III trials in 2016. Based on our confidence, either one of these two drug candidates’ in a pivotal trial would make ANTH a successful company and a highly attractive bolt-on acquisition.

ANTH is a BUY under 10 with a TARGET PRICE of 25″

Buenas tardes, hace algún tiempo que sigo este Valor y me gustaría me diese su opinión sobre si es buen momento para entrar en él una vez ha cerrado su primer gap en 2,66.

Gracias

A lista de seguimiento, gracias Super.