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Gainers & Losers Of Apr.11: WINT, GNCA, MESO, CYTX, ENDP...

April11-041117.jpg

The following are some of the biotech stocks that made their way onto the Day's Gainers & Losers' list of April 11, 2017.

GAINERS

1. Windtree Therapeutics Inc. (WINT)

Gained 20.97% to close Tuesday's (Apr.11) trading at $1.50.

News: The Company has successfully completed its second and final AEROSURF phase IIb clinical trial interim safety review.

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.

AEROSURF is 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).

2. Neothetics Inc. (NEOT)

Gained 15.47% to close Tuesday's trading at $2.09.

News: No news

Near-term catalyst:

-- Top-line data from a phase II proof of concept trial of LIPO-202 for the reduction of submental subcutaneous fat are expected to be reported in June 2017.

3. Conatus Pharmaceuticals Inc. (CNAT)

Gained 14.43% to close Tuesday's trading at $6.98.

News: No news

The Company's lead compound is Emricasan, for the treatment of patients with chronic liver disease.

Near-term catalysts:

-- A phase IIb trial of Emricasan in NASH cirrhosis patients, dubbed ENCORE-LF, is expected to be initiated in the second quarter of 2017.
-- Top-line data from an ongoing phase IIb trial of Emricasan in reducing hepatic venous pressure gradient in patients with compensated or early decompensated liver cirrhosis caused by nonalcoholic steatohepatitis (NASH), and severe portal hypertension, dubbed ENCORE-PH, are expected to be reported next year.
-- Top-line data from a phase IIb clinical trial of Emricasan evaluating potential improvements in fibrosis and steatohepatitis in patients with fibrosis caused by NASH, dubbed ENCORE-NF, are also expected next year.
-- Results after 2 years of twice-daily treatment or placebo from a phase 2b trial of Emricasan, in post-orthotopic liver transplant (POLT) recipients, dubbed POLT-HCV-SVR, are expected in the first half of 2018.

4. Aethlon Medical Inc. (AEMD)

Gained 11.67% to close Tuesday's trading at $2.68.

News: No news

Recent event: On March 13th, the Company announced the conclusion of its feasibility study designed to assess the safety of its Aethlon Hemopurifier in End-Stage Renal Disease (ESRD) volunteers who were also infected with Hepatitis C virus (HCV).

In the feasibility study, the Hemopurifier was found to be well tolerated. No device-related adverse events were observed.

5. Pulse Biosciences Inc. (PLSE)

Gained 10.86% to close Tuesday's trading at $23.89.

News: No news

Recent event:

The Company submitted a 510(k) to the FDA for its PulseTx System for a general indication for soft tissue ablation on March 14th.

The PulseTx System is based on the Company's proprietary technology called Nano-Pulse Stimulation, or NPS, and it marks Pulse Bio's first FDA 510(k) submission.

Near term catalyst:
-- The Company expects to initiate the first NPS pilot study in immuno-oncology this year.

Pulse Bio featured in our Company Spotlight column on February 17, 2017 when it was trading around $12.30.

6. MannKind Corp. (MNKD)

Gained 9.52% to close Tuesday's trading at $1.38.

News: No news

Recent event: On March 16th, 2017, the company reported Q4 and full-year 2016 financial results.

Net income in Q4, 2016 was $53.98 million or $0.56 per share on total net revenue of $12.40 million. This compared with a net loss of $277 million or $3.30 per share on nil revenue in the year-ago quarter.

7. Genocea Biosciences, Inc. (GNCA)

Gained 9.15% to close Tuesday's trading at $6.44.

News: The Company has been awarded the World Vaccine Congress 2017 Industry Excellence award for best therapeutic vaccine for GEN-003, an investigational immunotherapy to treat genital herpes.

Genocea reported positive efficacy data from its Phase 2 clinical trial of GEN-003 last March and positive 6-month results from its Phase 2b clinical trial of GEN-003 in January of this year.

Near-term catalysts:

-- Report 24-month data from Phase 2 clinical trial of GEN-003 in genital herpes in the second-half of 2017.
-- Report 12-month data from phase 2b trial of GEN-003 in genital herpes in the second-half of 2017.
-- Initiate phase III program of GEN-003 in genital herpes in Q4, 2017.

8. Mesoblast Ltd. (MESO)

Gained 8.73% to close Tuesday's trading at $11.08.

News: The Company announced that the phase III trial of its allogeneic mesenchymal precursor cell (MPC) product candidate MPC-150-IM in patients with moderate to advanced chronic heart failure (CHF) was successful in the pre-specified interim futility analysis of the efficacy endpoint in the trial's first 270 patients.

The trial is designed to enroll a total of about 600 patients.

The trial's Independent Data Monitoring Committee has also stated that they had no safety concerns relating to MPC-150-IM and formally recommended that the trial should continue as planned.

LOSERS

1. Cytori Therapeutics Inc. (CYTX)

Lost 34.88% to close Tuesday's trading at $1.12.

News: The Company has offered to sell 8.6 million shares of its common stock to the public at a price of $1.10 each.

The gross proceeds from the offering are expected to be approximately $9.5 million. The underwriter has a 45-day option to purchase up to 15% of additional shares of the Company's common stock.

The offering is expected to close on or about April 17, 2017.

2. Akari Therapeutics Plc (AKTX)

Lost 12.89% to close Tuesday's trading at $17.16. It's a pullback after having had gained 68% over the last 4 trading days.

News: No news

Near-term catalyst:

-- Interim results from the phase II trial evaluating Coversin in patients with PNH who have never received a complement blocking therapy will be released on April 24, 2017.

3. CombiMatrix Corp. (CBMX)

Lost 12.26% to close Tuesday's trading at $4.65.

News: No news

CombiMatrix is a clinical diagnostic laboratory serving the IVF, prenatal, miscarriage analysis and pediatric markets.

Recent event:

On Feb.22nd, the Company reported Q4 and full-year 2016 financial results.

The net loss attributable to common stockholders for the fourth quarter of 2016 narrowed to $558,000 or $0.22 per share on total revenue of $3.5 million. This compared with a net loss attributable to common stockholders of $1.7 million or $2.02 per share and revenue of $2.7 million in the fourth quarter of 2015.

The Company is confident of reaching positive cash flow from operations by the fourth quarter of 2017.

4. OncoMed Pharmaceuticals Inc. (OMED)

Lost 10.81% to close Tuesday's trading at $4.95. This is the stock's second straight day of decline.

News: On April 10th, the Company announced that its phase II trial of Demcizumab in pancreatic cancer missed primary endpoint. The other bad news yesterday was Bayer's decision of not to exercise its option to license OncoMed's the first-in-class Wnt pathway inhibitors Vantictumab and Ipafricept for strategic reasons. The stock lost more than 36% of its value on Apr.10th.

5. Endo International plc (ENDP)

Lost 9.35% to close Tuesday's trading at $10.76.

News: The Company announced that it intends to offer senior secured notes, subject to market and customary conditions.

Endo intends to use the net proceeds from the proposed offering, together with the proceeds of its new term loan facility and cash on hand, to repay all its outstanding loans and all other obligations under its existing credit facilities ") and to pay related fees and expenses.

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