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Gainers & Losers Of The Day: BNTC, PULM, CALA, STML, CORI...

feb2 020217

The following are some of the biotech stocks that made their way onto the Day's Gainers & Losers' list of February 2, 2017.

Gainers

1. Benitec Biopharma Ltd. (BNTC)

Gained 134.38% to close Thursday's trading at $3.75 on a volume of 9.93 million shares.

News: Benitec Biopharma announced it has made significant progress in ocular program which is under preclinical testing, specifically the one in which it is collaborating with 4D Molecular Therapeutics.

In November 2014, Benitec entered into an agreement with 4D Molecular Therapeutics for the development of next generation novel vectors to enable advancement of its age related macular degeneration (AMD) program.

More details about the output from Benitec's collaboration with 4D Molecular Therapeutics will be presented at the Association for Research in Vision and Ophthalmology (ARVO)-Asia meeting being held in Brisbane on February 5th to February 8th.

2. Diffusion Pharmaceuticals Inc. (DFFN)

Gained 55.88% to close Thursday's trading at $4.77. The stock gained an impressive 520% in 2 trading days - touching an intraday high of $15.50 on January 10, 2017 - and has since given back almost all of its gains.

News: No news

Anticipated event:

The company's lead investigational drug is Trans Sodium Crocetinate or TCS, which is being investigated to enhance the efficacy of radiation and chemotherapy.

TSC is designed to work by safely re-oxygenating oxygen deprived (hypoxic) tissue. Hypoxia is an especially critical obstacle in the treatment of cardiovascular and respiratory diseases, as well as in cancer.

A phase II study of TCS in Glioblastoma produced encouraging results - with overall survival increasing by 37% at 2 years. An end of phase II meeting with the FDA was held in May 2015 and the company was informed that a single phase III study could serve as the basis for approval.

Diffusion Pharma expects to begin enrollment in the phase III study of TSC in Glioblastoma in the first half of this year.

The company's shares were uplisted from OTC to the NASDAQ on November 9, 2016.

3. Pulmatrix Inc. (PULM)

Gained 36.73% to close Thursday's trading at $5.10. The stock touched a 52-week high of $6.98 during the day.

News: No news

Recent happenings:

Last month, the company's drug candidate PUR1900, under preclinical testing, for treating fungal infections in the lungs of cystic fibrosis patients, was designated as a "Qualified Infectious Disease Product" by the FDA.

The company's most-advanced program is PUR0200, a branded generic in clinical development for chronic obstructive pulmonary disease. PUR0200 has successfully completed phase I testing.

PUR0200 is being developed by Pulmatrix in partnership with Mylan N.V (MYL). The option for non-US marketing rights to PUR0200 is retained by Mylan.

4. Windtree Therapeutics Inc. (WINT)

Gained 27.07% to close Thursday's trading at $1.69.

News: No news

Near-term catalysts:

Windtree's lead product candidate is AEROSURF, a novel, investigational combination drug/device product to potentially reduce or eliminate the need for endotracheal intubation and mechanical ventilation in the treatment of premature infants with respiratory distress syndrome (RDS).

-- Top line data for first 3 dose groups in its phase 2a trial of AEROSURF administered to premature infants 26-28 week gestational age is expected this quarter (Q1, 2017).
-- Top line data from phase 2b clinical trial of AEROSURF administered to premature infants 28 to 32 week gestational age is expected in mid-2017.

The company had cash of $12.4 million as of September 30, 2016, which is expected to be sufficient to fund operations through February 2017. During its recent presentation last month, the company revealed that it is pursuing potential strategic and other transactions to secure needed additional capital.

5. Calithera Biosciences Inc. (CALA)

Gained 21.58% to close Thursday's trading at $8.45.

News: No news.

Recent happenings:

On January 30, 2017, Calithera signed a deal with Incyte Corp. (INCY) to develop CB-1158, a phase I drug candidate. As per the deal terms, Calithera stands to earn as much as $483 million from Incyte.

6. Ignyta Inc. (RXDX)

Gained 14.71% to close Thursday's trading at $5.85.

News: No news

Near-term catalysts:

The company's lead compound is Entrectinib, under development for solid tumors.

-- An updated data from two phase I clinical trials of Entrectinib - ALKA-372-001 study and the STARTRK-1 are expected to be presented this quarter.
-- A phase II clinical trial of Entrectinib, dubbed STARTRK-2, is ongoing - with interim data anticipated in Q2, 2017.

LOSERS

1. Stemline Therapeutics Inc. (STML)

Lost 42.56% to close Thursday's trading at $5.60.

News: The company reported that 1 more patient has died in its ongoing pivotal phase II trial of SL-401 in blastic plasmacytoid dendritic cell neoplasm (BPDCN).

The patient who died had developed capillary leak syndrome (CLS), a known, sometimes fatal, and well-documented side effect of SL-401.

The report about the patient death was received by the company on January 18, 2017, and on January 20, 2017, it priced its public offering of 4.5 million shares of its common stock at $10.00 each.

The safety profile for SL-401 includes CLS, and there have been previous deaths reported in patients with CLS in this trial, which have been disclosed in public presentations, the company noted.

2. Corium International Inc. (CORI)

Lost 21.14% to close Thursday's trading at $2.91.

News: Corium prices follow-on offering of common stock

The company has priced its underwritten public offering of 6.66 million shares of common stock at $3.00 each. Gross proceeds to Corium from this offering are expected to be approximately $20 million. The offering is expected to close on February 7, 2017.

3. EnteroMedics Inc. (ETRM)

Lost 14.08% to close Thursday's trading at $7.20. Pullback after yesterday's (Feb.1st) gain of over 33%.

News: No news

Following the Jan.5th news about the company's vBloc neurometabolic therapy having been implanted at MedStar Health in Maryland and Roper St. Francis in South Carolina, bringing the total number of institutes to have implanted the therapy to 13, the company's shares have been on a tear. The stock touched an intra-day high of $30.41 on Jan.10th, and has since given back most of its gains.

The vBloc therapy is approved for use in helping with weight loss in people aged 18 years and older who are obese. It has received FDA approval and CE Mark.

On January 18th, the company announced a $16.5 million underwritten public offering. The underwritten public offering and full exercise of over-allotment option, which brought home gross proceeds of $19.0 million closed on January 23rd.

Anticipated event: Q4 and full-year 2016 financial results scheduled for Feb.15, 2017.

4. Spring Bank Pharmaceuticals Inc. (SBPH)

Lost 9.82% to close Thursday's trading at $7.06.

News: No news

Near-term catalyst: Initial results from the first dosing cohort in phase II trial of SB9200 in chronic Hepatitis B, dubbed ACHIEVE, are expected during the first half of 2017.

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