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10-Q
ATHENEX, INC. filed this Form 10-Q on 05/09/2019
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We can provide no assurance that we will be successful in obtaining the FDA’s approval to commercialize oral paclitaxel and encequidar.

Lead candidate in the Src Kinase Inhibition platform: KX2-391 ointment, for Actinic Keratosis (AK)

Patient enrollment in two Phase 3 studies was completed in February 2018. The studies enrolled a total of 702 patients across 62 sites in the US. KX2-391 ointment 1% or vehicle (randomized 1:1) was self-administered to 25 cm2 of the face or scalp encompassing 4-8 typical AK lesions, once daily for 5 consecutive days.

In July 2018, we announced that both of our Phase 3 pivotal efficacy studies achieved their primary endpoint of 100% clearance of AK lesions at Day 57 within the face or scalp treatment areas, with each study achieving statistical significance (p<0.0001).

In March 2019, we presented topline results from the two Phase 3 studies in a late breaker session at the 2019 American Academy of Dermatology Annual Meeting. Results showed that 44% and 54% of patients in studies KX01-AK-003 and KX-01-AK-004, respectively, achieved 100% AK lesion clearance at Day 57 (see Table 1). The patient compliance rate in these two studies was greater than 99%. There was a statistically significant clearance rate in favor of the KX2-391 ointment versus the vehicle in each of the patient subgroups. Safety results showed that KX2-391 ointment was well tolerated. Adverse events were few. Treatment related adverse events were mild to moderate application site symptoms, such as pruritus or pain. There were no serious adverse events or early discontinuations due to study drug related adverse events. Local skin reactions (LSRs) (erythema, flaking/scaling, crusting, swelling, vesiculation/postulation and erosion/ulceration) were mostly mild to moderate. We believe that this product, if approved by the regulatory authorities, could have a major impact in the medical treatment of AK.

Table 1: Efficacy Results of KX2-391 Ointment in the Field Treatment of Actinic Keratosis

 

Study

KX01-AK-003

KX01-AK-004

% of Subjects in the Intent-To-Treat Population

(Number of Subjects)

KX2-391

N=175

Vehicle

N=176

p-value

KX2-391

N=178

Vehicle

N=173

p-value

100% AK Clearance on Day 57

44% (N=77)

5% (N=8)

<0.0001a

54% (N=97)

13% (N=22)

<0.0001a

Face

Scalp

50%

30%

6%

2%

<0.0001

<0.0001

61%

41%

14%

11%

<0.0001

0.0003

≥75% AK Clearance on Day 57

68%

16%

<0.0001a

76%

20%

<0.0001a

 

Note:

a = p-value calculated based on Cochran-Mantel-Haenszel (CMH)

 

New in-licensed programs: TCR-T Immunotherapy and Arginine Deprivation Therapy

 

In 2018, we commenced development of two new in-licensed programs. 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 the unique attributes of TCR mediated target recognition and provides a potent and selective TCR-T directed response against cancer cells.

We have three operating segments: our Oncology Innovation Platform, Global Supply Chain Platform and Commercial Platform. Since inception, we have devoted a substantial amount of our resources to research and development of our lead product candidates under our Orascovery, Src Kinase Inhibition research platforms, and TCR-T Immunotherapy and Arginine Deprivation Therapy. We have incurred significant net losses since inception. Our net losses were $36.2 million and $7.3 million for the three months ended March 31, 2019 and 2018, respectively. As of March 31, 2019 and December 31, 2018 we had an accumulated deficit of $478.9 million and $443.7 million, respectively. We expect to incur significant expenses and increasing operating losses for the foreseeable future. We anticipate that our expenses will increase substantially as we:

 

Continue to advance our lead programs, Orascovery and Src Kinase Inhibition research platforms, through clinical development;

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