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VTL To Dump ELAD System, KRYS Awaits Data Readout In Q4, COOL On Watch

pharma-020618_12sep18-lt.jpg

The following are some of the pharma/biotech stocks that posted the biggest percentage decline today.

1. Vital Therapies Inc. (VTL)

Lost 92.86% to close Wednesday's (Sep.12) trading at $0.45.

News: The phase III trial evaluating the Company's lead investigational product ELAD System in subjects with severe alcoholic hepatitis, dubbed VTL-308, failed to achieve primary and secondary endpoints of improvement in survival.

In light of the disappointing results, the Company has decided to cease any further development of the ELAD System and explore strategic options.

2. Krystal Biotech Inc. (KRYS)

Lost 14.71% to close Wednesday's trading at $17.91.

News: No news

Near-term Catalysts:

-- Data readout from phase I/II trial of KB103 in the treatment of dystrophic epidermolysis bullosa is expected in Q4, 2018.
-- The investigational new drug application (IND) for KB105, proposed for treatment of patients with transglutaminase 1 (TGM-1) deficient autosomal recessive congenital ichthyosis ("ARCI"), is expected to be filed in Q4, 2018, with clinical studies commencing in the second half of 2019.

3. ProQR Therapeutics N.V. (PRQR)

Lost 14.35% to close Wednesday's trading at $18.50.

News: No news

Recent events:

-- On September 5, the Company announced positive interim results from its phase I/II trial of QR-110 in patients with Leber's congenital amaurosis 10 (LCA10), the most common cause of blindness due to genetic disease in children. The news sent the stock as much as 120% to $17.55 that day.

-- On September 12, the Company announced the closing of its previously announced underwritten public offering of 6.61 million ordinary shares at a price to the public of $15.75 per share, including the full exercise of the underwriters' option to purchase additional shares. Gross proceeds from the offering totaled approximately $104.1 million.

Near-term Catalysts:
-- A phase I/II clinical trial of QR-313 in patients that have recessive dystrophic epidermolysis bullosa (RDEB) due to mutations in exon 73 of the COL7A1 gene, dubbed WINGS, is underway. Interim results from this trial are expected in late 2018, with full data expected in 2019.
-- A phase II/III pivotal trial of QR-110 in patients with Leber's congenital amaurosis 10 (LCA10) is expected to start in the first half of 2019.

4. Neon Therapeutics Inc. (NTGN)

Lost 13.65% to close Wednesday's trading at $9.55.

News: No news

Recent event:

The Company's shares debuted on The Nasdaq Global Select Market on June 27, 201, at an offering price of $16.00 each.

Near-term Catalysts:

Neon is a clinical-stage immuno-oncology company developing neoantigen-targeted therapies.

-- A phase 1b clinical trial of NEO-PV-01 in the metastatic setting, dubbed NT-001, has completed enrollment, with updated data expected to be presented in October 2018 at ESMO, and 52-week data expected in the first half of 2019.
-- Initiation of phase 1b clinical trial of NEO-PV-01 in metastatic melanoma combinations, dubbed NT-003, is expected in the second half of 2018.
-- The 52-week data from a phase Ib trial of NEO-PV-01 in Metastatic Non-Small Cell Lung Cancer, dubbed NT-002, is expected in the second half of 2019.
-- Submission of a European Clinical Trial Application (CTA) for NEO-PTC-01, a personal neoantigen T-cell therapy, in the first half of 2019.
-- Submission of an Investigational New Drug (IND) application for NEO-SV-01 in subset of ER+ breast cancer to the FDA in the first half of 2019.

5. PolarityTE Inc. (COOL)

Lost 12.47% to close Wednesday's trading at $17.90.

News: The Company reported fiscal third quarter 2018 financial results.

PolarityTE is a commercial-stage biotechnology and regenerative biomaterials company.

The net loss attributable to common shareholders for the third quarter ended July 31, 2018 was $17.2 million or $0.86 per share compared to a net loss of $5.2 million or $0.93 per for the three months ended July 31, 2017. The total revenue in the recent third quarter was $416 thousand compared to nil revenue in the year-ago quarter.

As of July 31, 2018, the Company had cash and cash equivalents of $84.8 million.

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