ATNX is a global biopharmaceutical company based in Buffalo, New York that is working to discover, develop, and commercialize novel therapies for the treatment of cancer. The company has several product candidates via its Orascovery and Src Kinase Inhibition research platforms. Their lead candidate is Oraxol (HM30181A tablet + Oral Paclitaxel), which has been studied across multiple clinical studies in advanced malignances and gastric cancer.
Oraxol has thus far completed four Phase 1 and 2 clinical studies. No maximum tolerated dose was reached and Oraxol has been well-tolerated by cancer patients overall. The company says it observed anti-cancer activity in a Phase 1/2 study of patients in gastric cancer with Oraxol monotherapy, where the overall survival in the study for 43 subjects was 10.7 months, which compared favorably to historical data for ramucirumab, the only FDA approved drug for second line treatment of gastric cancer. Athenex is currently conducting a Phase 3 study of Oraxol for the treatment of metastatic breast cancer in an open-label, randomized, multicenter study in approximately 360 adult female subjects. An interim analysis for the first 90 patients is expected this year. Oraxol is additionally poised to enter into a combination study for treatment of advanced gastric cancer with ramucirumab through a clinical trial collaboration with Eli Lilly and Company (LLY).
The company’s second most advanced candidate is KX-01, a compound that, as a free base, is believed to have advantageous physical properties for topical ointment formulations. A topical ointment with KX-01 showed promising results in a proof of concept clinical trial for actinic keratosis, a pre-cancerous skin lesion. Athenex completed enrollment of an approximately 160-patient Phase 2a study of KX-01 for treatment of AK in 2016 and expects complete primary endpoint data from this study in the first half of this year. Additionally, the company has received allowance from the FDA to conduct a Phase 3 study and expects to commence such a trial in the second half of this year.
In Q1, the company reported revs of $4.58 million, -1% y/y. The company derives its consolidated revenue primarily from the sales of API and medical devices by its Global Supply Chain Platform; licensing and collaboration projects conducted by its Oncology Innovation Platform, which generates revenue in the form of upfront payments, milestone payments and payments received for providing research and development services for the company’s collaboration projects and for other third parties; and grant awards from government agencies and universities for the company’s continuing research and development efforts. The company’s Global Supply Chain Platform manufactures API (active pharmaceutical ingredients) for use internally in research and development and clinical studies, and for sale to pharmaceutical customers globally.
Q1 net loss widened to $41 million from $10.6 million in the prior year period as R&D expenses spiked nearly 300% to $26.4 million. The company noted that the large increase in R&D costs was primarily due to increased licensing fees and increased payments for its proprietary drug programs. Cash and cash equivalents were $26 million as of March 31.
ATNX believes that the net proceeds from this offering, together with existing cash and cash equivalents and short-term investments will be sufficient to fund current operating plans through at least the next 12 months.