Will These 5 Biotechs Hit The Bulls-Eye Or Miss The Mark?

(RTTNews) - We have two more weeks left in June, and for the second quarter to end. The iShares Nasdaq Biotechnology ETF (IBB), a bellwether of investor sentiment, has lost nearly 8.5 percent of its value so far this quarter.

Provention Bio (PRVB), a clinical-stage biopharmaceutical company dedicated to intercepting and preventing immune-mediated diseases, which has returned over 390% so far this quarter, leads the list of gainers in the second quarter, thanks to encouraging news about its type 1 diabetes candidate PRV-031.

The biggest loser this quarter is InflaRx (IFRX), a clinical-stage biopharmaceutical company focused on developing treatments for a wide variety of autoimmune and other inflammatory diseases. The stock is down over 90% so far this quarter, and the Company's failed phase IIb study of IFX-1 in patients suffering from moderate to severe Hidradenitis Suppurativa, dubbed SHINE, reported early this month, is to be blamed.

PRVB and IFRX are just two examples of how notoriously volatile the biotech stocks can be when news related to clinical trial results are released.

Listed below are a few biotech companies that are slated to report their clinical study results in the coming weeks, if they stick to their timeline.

1. Aclaris Therapeutics Inc. (ACRS)

Aclaris is a biopharmaceutical company focused on immuno-inflammatory and dermatological diseases.

Watch out for...

A phase II trial evaluating the safety, efficacy, and dose response of two concentrations of ATI-502, a topical JAK1/3 inhibitor, on the regrowth of hair in patients with alopecia areata is underway, with data expected this quarter.

If all goes well as planned, the Company plans initiation of a phase III trial of ATI-502 as a topical treatment for alopecia areata in the first half of 2020.

Cash position:

As of March 31, 2019, Aclaris had cash of $136.8 million, which is expected to be sufficient to fund operations into the fourth quarter of 2020.

ACRS has traded in a range of $4.26 to $21.96. The stock closed Friday's (June 14, 2019) trading at $4.67, down 4.11%.

2. Intra-Cellular Therapies Inc. (ITCI)

Intra-Cellular Therapies is developing novel drugs for the treatment of neuropsychiatric and neurodegenerative diseases and diseases of the elderly, including Parkinson's and Alzheimer's disease.

The Company's lead drug candidate is Lumateperone, which is under phase III clinical development for the treatment of schizophrenia, bipolar depression and agitation associated with dementia, including Alzheimer's disease.

Watch out for...

Topline results from two phase III trials of Lumateperone as monotherapy in bipolar depression, dubbed Study 401 and Study 404, are expected this quarter.

Cash position:

At March 31, 2019, the Company had cash of $312.8 million.

ITCI has traded in a range of $10.21 to $23.62 in the last 1 year. The stock closed Friday's trading at $12.51, down 2.57%.

3. Krystal Biotech Inc. (KRYS)

Krystal Biotech is a gene therapy company focused on developing novel treatments for patients suffering from dermatological diseases through its proprietary gene therapy platform, known as Skin TARgeted Delivery platform, or STAR-D platform.

The Company's lead product candidate is KB103, a first-in-class topical gene therapy, for the treatment of dystrophic epidermolysis bullosa, or DEB, under phase I/II trial.

Interim data from the phase I/II trial of KB103, involving two adult Recessive Dystrophic Epidermolysis Bullosa ("RDEB"), NC1[+] patients aged 35 and 28 years old was reported last October. According to the Company, results on the 2 patients met all primary efficacy and safety endpoints in topically administered KB103 wounds.

Watch out for...

The final data from the phase I/II study of KB103 in dystrophic epidermolysis bullosa is due in the first half of this year.

Cash position:

On March 31, 2019, the Company had cash of $106.6 million.

KRYS has traded in a range of $13.66 to $38.95 in the last 1 year. The stock closed Friday's trading at $27.20, down 11.20%.

4. Minerva Neurosciences Inc. (NERV)

Minerva Neurosciences is a clinical-stage biopharmaceutical company focused on developing innovative therapies to treat unmet medical needs of central nervous system (CNS) disorders.

The Company's lead product candidate is Roluperidone, being evaluated as a monotherapy in a phase III trial for negative symptoms in patients diagnosed with schizophrenia.

Also in the pipeline are Seltorexant, under a phase IIb clinical trial in insomnia disorder, and MIN-117, in a phase IIb trial in patients with Major Depressive Disorder who also have symptoms of anxiety.

Watch out for...

The top-line results from the phase IIb trial of Seltorexant in insomnia are anticipated in the second quarter of 2019.

Cash position:

As of March 31, 2019, the Company had cash of $79.3 million.

NERV has traded in a range of $4.40 to $12.95 in the last 1 year. The stock closed Friday's trading at $4.40, down 2.22%.

5. Verrica Pharmaceuticals Inc. (VRCA)

Verrica Pharmaceuticals is a medical dermatology company.

The Company's lead product candidate is VP-102, a proprietary topical drug-device combination therapy containing a novel topical solution of 0.7% cantharidin, for the treatment of molluscum and verruca vulgaris (common warts).

In January of this year, the Company announced positive topline results from its phase III pivotal trials with VP-102 for the treatment of molluscum contagiosum, dubbed CAMP-1 and CAMP-2.

Watch out for...

Topline results from a phase II trial of VP-102 in verruca vulgaris, dubbed COVE-1, are expected in the second quarter of 2019.

VRCA has thus far hit a low of $6.44 and a high of $23.29. The stock closed Friday's trading at $9.35, down 5.27%.