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SEC Filings

10-Q
ATHENEX, INC. filed this Form 10-Q on 05/09/2019
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Oratopo, combining HM30181A with an oral dosage form of topotecan; and

 

Eribulin ORA, combining HM30181A with an oral dosage form of eribulin.

We have received approval of the International Nonproprietary Name (INN) “encequidar” for our novel P-gp pump inhibitor molecule, HM30181A.

Src Kinase Inhibition platform—Targets the tyrosine kinase protein in regulating cell growth that leads to blockade of metastasis:

 

KX2-391 (also known as KX-01) ointment, Src kinase inhibitor topically administered to treat skin cancers and pre-cancers;

 

KX2-391 oral, Src kinase inhibitor orally administered to treat certain solid and liquid tumors; and

 

KX2-361 (also known as KX-02), Src kinase inhibitor orally administered to treat brain cancer, such as glioblastoma multiforme (GBM).

TCR-T Immunotherapy and Arginine Deprivation Therapy platformlicensed in July 2018, and are still in early stage R&D development phase:

 

The TCR-T immunotherapy technology harnesses and enhances the patient’s own immune cells to target and eliminate cancer.  It is a cell-based therapy that takes advantage of unique attributes of TCR mediated target recognition and provides a potent and selective TCR-T directed response against cancer cells.

 

The Arginine Deprivation Therapy product, based on pegylated genetically engineered human arginase, targets cancer growth and survival by interrupting the supply of an essential amino acid, arginine, to a proportion of cancers with disrupted urea cycle.

We expense research and development costs as incurred. We record costs for certain development activities, such as clinical trials, based on an evaluation of the progress to completion of specific tasks using data such as patient enrollment or clinical site activations. We do not allocate employee-related costs, depreciation, rental and other indirect costs to specific research and development programs because these costs are deployed across multiple product programs under research and development.

We cannot determine with certainty the duration, costs and timing of the current or future preclinical or clinical studies of our drug candidates. The duration, costs, and timing of clinical studies and development of our drug candidates will depend on a variety of factors, including:

 

The scope, rate of progress, and costs of our ongoing, as well as any additional, clinical studies and other research and development activities;

 

Future clinical study results;

 

Uncertainties in clinical study enrollment rates;

 

Significant and changing government regulation; and

 

The timing and receipt of any regulatory approvals.

A change in the outcome of any of these variables with respect to the development of a drug candidate could mean a significant change in the costs and timing associated with the development of that drug candidate.

Research and development activities are central to our business model. We expect our research and development expenses to continue to increase for the foreseeable future as we continue to support the clinical trials of Oraxol, Oratecan, Oradoxel, Oratopo, Eribulin ORA, KX-01 ointment, KX-01 oral and KX-02, as well as initiate and prepare for additional clinical and preclinical studies, including TCR-T and Arginine deprivation program activities. We also expect spending to increase in the research and development for API, 503B and specialty products. There are numerous factors associated with the successful commercialization of any of our drug candidates, including future trial design and various regulatory requirements, many of which cannot be determined with accuracy at this time based on our stage of development. Additionally, future commercial and regulatory factors beyond our control will likely impact our clinical development programs and plans.

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