Health and Healthcare

Why Investors Still Like Celator Pharma Despite a Loss

Chris Lange

Published: March 21, 2016 12:15 pm

Last Updated: January 13, 2020 11:42 am

Celator Pharmaceuticals Inc. (NASDAQ: CPXX) reported its fourth-quarter financial results before the markets opened on Monday. The company said it had a net loss of $0.13 per share. That compared to the consensus estimate from Thomson Reuters of a net loss of $0.12 per share and a net loss of $0.07 per share reported in the same period of last year.

This company has made a big push recently and has been big on the momentum trade. With these results it appears that investors don’t mind the loss, and they are looking ahead to the future.

Recently, the company announced that the Phase 3 trial for Vyxeos in patients with high-risk (secondary) acute myeloid leukemia demonstrated a statistically significant improvement in overall survival.

The company listed its expected milestones for Vyxeos as:

• New Drug Application (NDA) in third quarter of 2016.
• Market Authorization Application (MAA) submission in first quarter of 2017.
• Prescription Drug User Fee Act (PDUFA) date (assuming FDA priority review) in mid-2017.
• Committee for Medicinal Products for Human Use (CHMP) opinion date in first quarter of 2018.

In 2015, Celator continued to meet important milestones with VYXEOS and the CombiPlex platform. Recently, we announced positive results from our Phase 3 trial in patients with high-risk (secondary) acute myeloid leukemia (AML), comparing VYXEOS to the long established standard of care, known as 7+3.  We submitted results from the Phase 3 trial to the American Society of Clinical Oncology 2016 Annual Meeting. Based on these results, we expect to submit a New Drug Application to the FDA in the third quarter of this year.  In addition, in 2015 we embarked on a broader clinical development program via several trials evaluating VYXEOS in other AML patient populations as well as other blood cancers. Lastly, we were pleased to report data from novel combinations involving targeted therapies based on our CombiPlex technology platform. This is a very exciting and transformational time for Celator.

On the books, cash and cash equivalents totaled $23.3 million at the end of the quarter, compared to $32.4 million at the end of the same period from the previous year.

Shares of Celator were trading up 13% at $9.82 on Monday, with a consensus analyst price target of $18.33 and a 52-week trading range of $1.12 to $10.25.