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CVM Gearing Up For Big Event, BLFS Full Of Life, CRON Abuzz, AXON Awaits Data

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The following are some of today's top gainers in the pharma/biotech sector.

1. CEL-SCI Corporation (CVM)

Gained 35.59% to close Tuesday's (Aug.21) trading at $1.60.

News: In its letter to the shareholders for the upcoming annual meeting, the Company once again reminded that top line results from a phase III trial of its investigational immunotherapy Multikine in the treatment of head and neck cancer may be available as soon as early 2019.

The Company also highlighted why its market cap of about $20 million makes little sense. In the past 18 months, several successful Phase 3 cancer immunotherapy companies were sold for $7 billion to almost $12 billion. They had positive survival data from their pivotal studies, but had not yet received FDA approval. In addition, recently one cancer immunotherapy company with Phase 3 studies that were not yet complete was sold for about $1.6 billion.

2. Agenus Inc. (AGEN)

Agenus is an immuno-oncology company with a pipeline of immune checkpoint antibodies, cancer vaccines and adoptive cell therapies.

Gained 18.24% to close Tuesday's trading at $1.88.

News: No news

Pipeline:

This year alone, 3 investigational new drug applications (INDs) from its discovery engines have been filed and 3 additional INDs will be filed by year end.

A phase 1/2 study designed to evaluate the safety, tolerability, pharmacokinetics, and clinical activity of combination AGEN1884 and AGEN2034 in patients with advanced solid tumors, launched in December 2017, is underway.

3. BioLife Solutions Inc. (BLFS)

Gained 16% to close Tuesday's trading at $24.14.

News: No news

Recent event:

On August 9, the Company reported financial results for the three months ended June 30, 2018.

Net income attributable to common shares was $1.05 million or $0.05 per share on revenue of $5.2 million in the recent second quarter. This compared to a loss of $768 thousand or $0.06 per share and revenue of $2.56 million in the year-earlier quarter.
Looking ahead, the Company expects 2018 to be its first full year of profitability.

4. Axovant Sciences Ltd. (AXON)

Gained 14.43% to close Tuesday's trading at $2.30.

News: No news

Clinical Trials & Near-term Catalysts:

-- Top-line data from a phase II study evaluating Nelotanserin for treatment of REM Sleep Behavior Disorder in subjects with Lewy body dementia are expected in the second half of 2018.
-- Initiate a phase I/II dose escalation study of AXO-Lenti-PD, an investigational gene therapy, in patients with advanced Parkinson's disease by the end of 2018, with initial clinical data from the study available in 2019.
-- Initiate a placebo-controlled clinical study of AXO-AAV-OPMD, a potential one-time treatment for oculopharyngeal muscular dystrophy, in 2019.

5. CohBar Inc. (CWBR)

Gained 13.25% to close Tuesday's trading at $5.64.

News: No news

Near-term Catalysts:

-- A phase 1a/1b safety and biomarker study of CB4211, the Company's lead mitochondria based therapeutic candidate under development as a potential treatment for non-alcoholic steatohepatitis (NASH) and obesity, was initiated as recently as last month. Data from the study are expected to be available in early 2019.

Recent events:

-- On August 14, the Company reported financial results for the second quarter ended June 30, 2018.

Net loss for the recent second quarter widened to $3.32 million or $0.08 per share from $1.91 million or $0.05 per share in the comparable year-ago quarter. CohBar had cash and investments of $28 million on June 30, 2018.

-- On June 22, the company was added to the Russell 2000 and 3000 Indexes.

6. Cronos Group Inc. (CRON)

Gained 13.25% to close Tuesday's trading at $8.29.

News: The Company announced its initial supply agreements for retail distribution, both government-operated and private, across Canada for the upcoming launch of the cannabis recreational market in October 2018.

Cronos Group has secured listings and signed binding master supply agreements with both the Ontario Cannabis Retail Corporation and the BC Liquor Distribution Branch. The Company has also secured listings and has accepted supplier terms with the Nova Scotia Liquor Corporation and Prince Edward Island Liquor Corporation.

7. KalVista Pharmaceuticals Inc. (KALV)

KalVista is a clinical-stage company developing drugs for hereditary angioedema, diabetic macular edema, and other plasma kallikrein-associated diseases.

Gained 12.26% to close Monday's trading at $16.66.

News: No news

Clinical Trials & Near-term Catalysts:

-- The Company's most advanced program is KVD001, an intravitreally administered plasma kallikrein inhibitor, under phase II trial in patients with diabetic macular edema, with data expected to be reported in the second half of 2019.
-- A phase II trial of KVD900 as an on-demand treatment for acute Hereditary Angioedema attacks is expected to be initiated in late 2018, with completion anticipated in mid-2019.

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