Inovio Pharmaceuticals, Inc. (INO - Free Report) incurred a loss of 34 cents per share for the fourth quarter of 2018, wider than the Zacks Consensus Estimate of a loss of 30 cents and the year-ago loss of 24 cents.
Inovio generated revenues of $2.5 million in fourth-quarter 2018, missing the Zacks Consensus Estimate of $2.69 million. Revenues decreased 71.6% from the year-ago quarter’s figure of $8.8 million due to significantly lower collaboration payments and grants compared to the year-ago period.
Inovio’s shares fell 4.8% in after-market trading on Mar 12, following the dismal quarterly results. Shares of Inovio have declined 11% year to date against the industry’s increase of 11.9%.
Research and development expenses increased 7.3% to $26.4 million due to higher expenses related to clinical studies, partially offset by lower expenses related to the DARPA Ebola grant.
General and administrative expenses decreased 30% to $5.6 million in the fourth quarter.
Inovio reported total revenues of $30.5 million in 2018, down 27.7% year over year. The company earned $15.4 million from AstraZeneca (AZN - Free Report) under a collaboration agreement, $8.8 million in DARPA Ebola grant and received an agreement termination payment of $6.1 million from Roche (RHHBY - Free Report) in 2017. The year-over-year decline in revenues was partially offset by an upfront payment of $23 million from China-based ApolloBio related to amendment of an agreement for VGX-3100 rights and an increase in grant funding from the CEPI grant of $4.3 million.
For the full year, the company incurred a loss of $1.05 per share, 3.7% narrower than the year-ago period due to lower operating expenses.
Pipeline and Other Updates
VGX-3100, an HPV immunotherapy, is the most advanced candidate in the company’s pipeline.
VGX-3100 is currently being evaluated in a phase III study (REVEAL 1) for the treatment of cervical dysplasia, caused by human papillomavirus (“HPV”). The company expects to complete enrollment in REVEAL 1 study soon and has initiated enrollment in the confirmatory REVEAL II study. The company plans to submit a biologics license application (“BLA”) in 2021. Two more phase II studies are examining the efficacy of VGX-3100 on patients with vulvar dysplasia and anal dysplasia.
Apart from VGX-3100, Inovio has several candidates in its pipeline under early-to-mid-stage development.
The company is evaluating immuno-oncology combo, INO-5401 plus INO-9012, in two phase I/II studies. One study is evaluating thecombo in combination with Regeneron’s (REGN - Free Report) cemiplimab on patients with newly-diagnosed glioblastoma while the other is in combination with Roche’s Tecentriq as a treatment for advanced or metastatic bladder cancer. Interim data from both the studies are expected this year.
Inovio expects data in 2019 from a phase I/IIa study, evaluating its Middle East respiratory syndrome ("MERS") vaccine, INO-4700, to prevent infection from the deadly virus. The company expects to begin a phase II program on MERS vaccine in the Middle East during the second half of 2019.
In February 2019, Inovio announced initiation of first-ever human study of INO-A002, a DNA-encoded monoclonal antibody (dMAb), as a prevention treatment for Zika virus.
MEDI0457 (a combination of VGX-3100 and its DNA-based IL-12 cytokine), out-licensed to AstraZeneca, is currently being evaluated in a phase II study combined with the AstraZeneca’s PD-L1 checkpoint inhibitor, Imfinzi, for the treatment of HPV-caused cervical, head and neck cancers. The company announced that complete response was achieved in two patients or was 50%.
In December 2018, Inovio had announced the initiation of a phase II study to evaluate the anti-tumor activity of MEDI0457 in combination with Imfinzi (durvalumab) in several cancer indications associated with HPV.
Inovio currently carries a Zacks Rank #4 (Sell).
You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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