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This Day That Year: Athenex

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Shares of Athenex Inc. (ATNX) have returned nearly 46% over the last 1 year while the iShares NASDAQ Biotechnology Index (ETF) has gained a mere 12% during the same period.

It was on this day last year, i.e. on June 14, 2017, that Athenex debuted on the Nasdaq by setting a public offering at $11.00 per share.

Athenex is a global biopharmaceutical company focused on developing novel therapies for the treatment of cancer. The Company's Oncology pipeline includes three research platforms - Orascovery, Src Kinase Inhibition, and Dual inhibition - with the first two being clinical platforms and the third under pre-clinical testing.

The lead product candidate developed through the Orascovery research platform is Oraxol, for metastatic breast cancer.

Oraxol is a novel oral formulation of Paclitaxel, a very effective and commonly used chemotherapy treatment for many cancers, combined with HM30181A (a novel orally non-absorbable gastrointestinal tract P-glycoprotein pump inhibitor).

A phase III international trial comparing Oraxol monotherapy against intravenous (IV) paclitaxel monotherapy in patients with metastatic breast cancer is underway. The study's target sample size is 360 patients.

The first interim analysis of the study was conducted last October when 90 patients completed 18 weeks of treatment, and the independent Drug Safety Monitoring Board (DSMB) unanimously recommended continuation of the study.

The second interim analysis of the study is scheduled at 180 patients. With more than 180 patients having already been enrolled in the trial, the second interim analysis is expected to be conducted in the third quarter of 2018.

A phase 1b clinical trial of Oraxol (oral paclitaxel) plus Eli Lilly's (LLY) Cyramza  in gastric cancer patients who failed previous chemotherapies is also underway.

The Orascovery platform was developed by Hanmi Pharmaceuticals and licensed exclusively to Athenex for all major worldwide territories except Korea, which is retained by Hanmi.

In addition, there are three other major clinical product candidates in phase I testing in the Orascovery platform namely, Oratecan, Oradoxel and Oratopo, which include HM30181A co-administered with an oral formulation of the widely used IV-administered chemotherapeutic agents, irinotecan, docetaxel and topotecan, respectively.

Last December, the Company initiated the preparation of an IND for oral eribulin co-administered with HM30181A.

Next up is the Src Kinase inhibition platform, which consists of three key clinical product candidates namely, KX-01 ointments for actinic keratosis, or AK, pre-cancerous lesions and psoriasis; KX-01 oral for solid and liquid tumors and potential skin cancer indications and pre-cancerous lesions and KX-02 for glioblastoma multiforme, or GBM.

The most advanced investigational product in this research platform is KX-01 ointment (KX2 391), which is under two phase III trials for treatment of actinic keratosis, or AK, a pre-cancerous skin lesion. Enrollment in both the phase III trials have been completed.

The trials are expected to be complete in June 2018, with a 12-month recurrence follow-up period anticipated to be complete for the last subject in June 2019.

The final data for the two phase III trials are expected to be available in the fourth quarter of 2019.

In addition to the Oncology pipeline, the Company has a Commercial Platform and a Global Supply Chain Platform.

The Commercial platform markets and sells a variety of in-licensed pharmaceutical products, which are therapeutically related to its proprietary portfolio.

The Global Supply Chain Platform manufactures API for use internally in its research and development and clinical studies, and for sale to pharmaceutical customers globally.

Recent event:

On May 14, 2018, the Company reported  financial results for the first quarter ended March 31, 2018.

Net loss attributable to the Company in the recent first quarter narrowed to $7.3 million or $0.12 per share from $40.98 million or $1.01 per share in the year-ago quarter.

Total revenue in the first quarter of 2018 soared to $37.84 million from $4.58 million in the year-earlier quarter. Revenue is derived from licensing fees, proprietary product sales, and API product sales.

Looking ahead to full-year 2018, the Company expects revenue to be in the range of $100 million to $125 million, The annual revenue reported in 2017 was $38 million.

Athenex ended March 31, 2018 with cash of $106.5 million.

ATNX has traded in a range of $12.30 to $20.79 over the last 1 year. The stock closed Wednesday's trading at $17.50, up 4.42%.

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