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MBIO Keeps Galloping, GERN On Fast Track, APVO Awes, INSY Continues Descent

Oct31 103117

The following are some of the biotech stocks that made their way onto the Day's Gainers & Losers' list of October 31, 2017.

GAINERS

1. Mustang Bio Inc. (MBIO)

Gained 17.62% to close Tuesday's (Oct 31st) trading at $11.75. This is the second straight day of gain for the stock.

News: The Company reported promising preclinical data of MB-103 HER2 chimeric antigen receptor engineered T (CAR T) cells targeting HER2+ breast cancer metastasis to the brain. The data support the clinical development of this therapy.

Pipeline:

Mustang Bio is focused on developing CAR T-cell therapies to cure cancer, and its lead CAR T therapies in clinical development include MB-101 in glioblastoma and MB-102 in acute myeloid leukemia.

MB-103 for glioblastoma multiforme; MB-104 for multiple myeloma; MB-105 for prostate, pancreatic, gastric & bladder cancers and MB-106 for B-cell non-Hodgkin Lymphoma are the Company's preclinical CAR T product candidates.

Near-term catalysts:

-- Read out phase I data of MB-101 in glioblastoma and MB-102 in acute myeloid leukemia in early 2018.
-- Initiate a first-in-human phase I study of MB-103 in 2018.

2. Geron Corp. (GERN)

Gained 9.22% to close Tuesday's trading at $2.25.

News: The FDA has granted Fast Track designation to the Company's investigational drug candidate Imetelstat for the potential treatment of adult patients with lower risk myelodysplastic syndromes.

Imetelstat is being evaluated in an ongoing Phase 2/3 clinical trial, dubbed IMerge, in transfusion dependent patients with Low or Intermediate-1 risk MDS who have relapsed after or are refractory to prior treatment with an erythropoiesis stimulating agent.

3. Intellia Therapeutics Inc. (NTLA)

Gained 8.89% to close Tuesday's trading at $31.12.

Intellia is a genome editing company focused on developing curative therapeutics using CRISPR technology.

News: The Company announced financial and operational results for the third quarter of 2017.

Net loss widened to $15.4 million or $0.44 for the third quarter 2017 from $7.5 million or $0.22 in the third quarter of 2016. Collaboration revenue was $7.3 million for the third quarter of 2017 compared to $4.9 million for the third quarter of the prior year.

As of September 30, 2017, the Company had $222 million in cash and cash equivalents.

4. Cellular Biomedicine Group Inc. (CBMG)

Gained 8.67% to close Tuesday's trading at $10.65.

News: No news

Pipeline:

A phase I trial of C-CAR011 in adult patients with r/r B-cell Acute Lymphoblastic Leukemia in China, and a new independent phase I trial of C-CAR011 in patients with chemorefractory and aggressive Diffuse Large B-Cell Lymphoma, dubbed CARD-1, are underway.

Near-term catalyst:

The Company is slated to report Q3 financial results next week.

5. Restoration Robotics Inc. (HAIR)

Gained 8.62% to close Tuesday's trading at $7.18.

News: No news

Recent event:

-- On October 16, 2017, the Company announced the closing of its initial public offering of 3.57 million shares of common stock at a public offering price of $7.00 each. The Company's common stock began trading on The NASDAQ Global Market on October 12, 2017.

The Company commercializes the ARTAS Robotic Hair Restoration System, which is CE-marked and FDA cleared.

6. Aptevo Therapeutics Inc. (APVO)

Gained 8.56% to close Tuesday's trading at $2.85.

News: The Company presented new preclinical data on APVO436demonstrating rapid and significant reduction in skeletal tumor burden in mice with well-established and disseminated tumors.

APVO436 is being developed for the treatment of acute myeloid leukemia (AML), a form of blood and bone marrow cancer that is characterized by rapid disease progression.
The Company plans to advance APVO436 into the clinic next year.

Pipeline:

In the pipeline are two clinical drug candidates - MOR209/ES414 monotherapy in patients with metastatic castration-resistant prostate cancer, under phase I trial, and Otlertuzumab for chronic lymphocytic leukemia, under phase II study.

The Company also has 4 marketed drugs.

LOSERS

1. Oxford Immunotec Global PLC (OXFD)

Lost 15.69% to close Tuesday's trading at $13.22.

News: The Company reported a wider-than-expected loss for the third quarter ended September 30, 2017 and tweaked its revenue forecast for full year 2017.

Net loss for the third quarter of 2017 widened to $16.9 million or $0.70 per share from $4.0 million or $0.18 per share, in the third quarter of 2016. Revenue for the recent third quarter rose 17% to $30.4 million from $26.1 million in the third quarter of 2016.

Analysts polled by Thomson Reuters were expecting the Company to incur a loss of $0.24 on revenue of $30.05 million.

For full year 2017, the Company now expects revenue of between $103.5 and $104.5 million compared to prior revenue guidance of between $103 and $106 million.

2. INSYS Therapeutics Inc. (INSY)

Lost 10.28% to close Tuesday's trading at $5.15.

Trading in the company's stock was halted on October 26, 2017 at 16:55:13 Eastern Time, and it resumed only on October 31, 2017 at 10:00:00 a.m., Eastern Time.

Recent events:

-- On October 26, 2017, the Company's founder and majority owner, John N. Kapoor, was arrested for allegedly bribing doctors and pharmacists to prescribe "Subsys", a Fentanyl spray, intended for cancer patients experiencing breakthrough pain.
-- On October 29, 2017, Kapoor stepped down from his seat on the Board of Directors of INSYS. The same day, another director Patrick P. Fourteau also relinquished his post.

3. Applied Genetic Technologies Corporation (AGTC)

Lost 8.11% to close Tuesday's trading at $3.40.

News: No news

Upcoming event:

-- The Company is slated to report financial results for the first quarter ended September 30, 2017 after the market closes on Tuesday, November 7, 2017.

In the fourth quarter ended June 30, 2017, net loss was $3.2 million or $0.18 per share compared to a net income of $2.73 million or $0.15 per share in the year-ago quarter. Revenue for the fourth quarter of 2017 dropped to $8.34 million from $12.11 million in the comparable year-ago period.

4. Corvus Pharmaceuticals Inc. (CRVS)

Lost 7.87% to close Tuesday's trading at $13.58.

News: No news

Pipeline:

The Company's lead drug candidate is CPI-444, which is under Phase 1/1b study, being evaluated both as a single agent and in combination with Roche's Tecentriq in renal cell cancer (RCC) and non-small cell lung cancer (NSCLC). The Company presented positive results from the study on June 6, 2017.

Near-term catalyst:

-- Additional data from the Phase 1/1b study of CPI-444 are expected to be presented at the Society for Immunotherapy of Cancer (SITC) 32nd Annual Meeting on November 11, 2017.

5. Voyager Therapeutics Inc. (VYGR)

Lost 7.35% to close Tuesday's trading at $21.06.

News: Sanofi Genzyme decided not to exercise the option for ex-U.S. development and commercial rights to Voyager's VY-AADC program for advanced Parkinson's disease.
Voyager now gains worldwide rights to VY-AADC program. The Company plans to start the global, pivotal Phase 2-3 program of VY-AADC later this year.

6. Presbia PLC (LENS)

Lost 7.20% to close Tuesday's trading at $3.61.

News: No news

Pipeline:

The Company's lead product candidate is Presbia Flexivue Microlens, a revolutionary optical lens implant for treating presbyopia, the age-related loss of near vision. The Presbia Flexivue Microlens is currently approved for sale in 42 countries around the world.

Near-term catalyst:

-- The Company is planning to make its final submission to the FDA seeking approval of Presbia Flexivue Microlens before the end of 2017 in anticipation of approval in 2018.

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