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PTI

Proteostasis

$4.17

-0.14 (-3.25%)

07:07
03/25/19
03/25
07:07
03/25/19
07:07

Proteostasis reports Phase 1 results from CFTR modulators

Proteostasis Therapeutics announced results from Phase 1 clinical studies of its proprietary cystic fibrosis transmembrane conductance regulator modulators: PTI-801, a third-generation CFTR corrector; PTI-808, a novel CFTR potentiator; and PTI-428, a novel CFTR amplifier. This comprehensive data set includes efficacy and safety data from 14-day studies of PTI's proprietary combination therapy, as well as separate studies of PTI-801 over 14 days and PTI-428 over 28 days as add-on treatments to background tezacaftor/ivacaftor therapy, in CF subjects. Endpoints including safety, changes in sweat chloride concentration and in percent predicted FEV1 were assessed and evaluated. In a per protocol analysis, a PTI-801 dose-dependent improvement in ppFEV1 and SC concentration was observed across cohorts. Further, improvement in ppFEV1 did not reach a plateau by day 14, unlike the response profile in the company's previously reported mid-dose doublet and in reported results from non-PTI triple combinations, a finding that affirms PTI's plan for longer duration studies. Based on the totality of data, the company will be launching three new Phase 2, 28-day studies in CF subjects with at least one F508del mutation. The studies will employ entry criteria comparable to those used in other CFTR modulator combination studies. They will include a placebo controlled, triple and double combination trial in up to 30 patients exploring PTI-801 and PTI-808 with or without PTI-428 over a 28-day treatment period. PTI's CFTR modulators will also be evaluated in a homogeneous population over a longer duration. These studies will provide insight on the magnitude of PTI-428 contribution to efficacy.

PTI Proteostasis
$4.17

-0.14 (-3.25%)

11/07/18
CANT
11/07/18
INITIATION
Target $21
CANT
Overweight
Cantor sees 'clear opportunity' for Proteostasis, starts at Overweight
Cantor Fitzgerald analyst Elemer Piros last night initiated coverage of Proteostasis (PTI) with an Overweight rating and $21 price target. Proteostasis is developing CFTR modulator therapies for the treatment of cystic fibrosis, Piros tells investors in a research note. The analyst sees a "clear opportunity" for Proteostasis to carve out a good portion of the market and make a name for itself in CF. Vertex (VRTX) has opened the door for developing CFTR modulators, says Piros.
11/07/18
PIPR
11/07/18
NO CHANGE
Target $14
PIPR
Overweight
Piper Jaffray sees 'huge valuation disconnect' between Proteostasis, Vertex
Piper Jaffray analyst Edward Tenthoff notes that Proteostasis (PTI) ended Q3 with cash of $46M million subsequently completed an equity financing and sold 1.4M shares through an ATM, bringing pro forma cash to about $138M, which he estimates will fund the company into 2020. The primary driver remains initial Phase I data on Proteostasis' proprietary TripleRx regimen in homozygous F508del Cystic Fibrosis this quarter, he contends, adding that he remains encouraged based on recently reported positive Phase I data on proprietary CFTR potentiator PTI-808 and corrector PTI-801 in homozygous F508del CF patients. The analyst sees a "huge valuation disconnect" between Proteostasis and CF market leader Vertex (VRTX), and reiterates an Overweight rating and $14 price target on the former's shares.
11/07/18
11/07/18
INITIATION

On The Fly: Top analyst initiations
Catch up on today's top analyst initiations with this list compiled by The Fly: 1. Linde plc (LIN) initiated with a Market Perform at BMO Capital. 2. Posco (PKX) initiated with an Equal Weight at Morgan Stanley. 3. Proteostasis (PTI) initiated with an Overweight at Cantor Fitzgerald. This list is just a portion of The Fly's analyst coverage. To see The Fly's full Street Research coverage, click here.
12/17/18
PIPR
12/17/18
NO CHANGE
PIPR
Proteostasis deal with Genentech strenghtens balance sheet, says Piper Jaffray
Piper Jaffray analyst Edward Tenthoff reiterated an Overweight rating and $14 price target on Proteostasis (PTI), noting the company announced an agreement with Roche's (RHHBY) Genentech to license small molecule modulators of an undisclosed target that lie outside of Cystic Fibrosis, which makes the company eligible for $100M in upfront and milestone payments plus royalties. Tenthoff sees this deal strengthening Proteostasis' balance sheet. Additionally, Tenthoff is optimistic on Proteostasis' TripleRx combo, and expects full Phase I TripleRx data in Q1 of 2019. Longer term, the analyst anticipates TripleRx approval in 2021, with global sales of $2.0B by 2026.

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