Apellis Pharmaceuticals, Inc.


APLS

reported first-quarter 2021 loss per share of $2.32, wider than the Zacks Consensus Estimate of a loss of $1.69. The company had reported a loss of $2.29 per share in the year-ago quarter.

With no approved drug in its portfolio, the company does not generate revenues from the sale of products. The Zacks Consensus Estimate for revenues was $2 million. In the year-ago quarter, the company did not record any revenues.

Shares of Apellis have declined 20.8% in the year so far against the

industry’s

increase of 0.2%.

Quarter in Detail

Research and development (R&D) expenses were $84 million in the first quarter of 2021 compared with $69.3 million for the same period in 2020.

General and administrative expenses were $40.6 million in the first quarter of 2021 compared with $29.5 million reported in the year-ago quarter.

Apellis ended the first quarter of 2021 with cash, cash equivalents and marketable securities of $723.7 million, lower than $877.6 million at the end of the fourth quarter of 2020. Per the company, its cash and investments at the end of first-quarter 2021 is enough to support cash runway through the second half of 2022.

Pipeline Update

Apellis’ lead pipeline candidate, pegcetacoplan, is being developed for subcutaneous administration in several indications.

Notably, a new drug application for pegcetacoplan to treat paroxysmal nocturnal hemoglobinuria (“PNH”) is currently under priority review in the United States. A decision from the FDA is expected on May 14, 2021. A potential approval will be a boost for the company as it can generate revenues from the sale of the drug in future quarters.

Meanwhile, the company has also filed a marketing authorization application to the European Medicines Agency for pegcetacoplan for treating PNH with a potential decision from the European Commission expected in the second half of 2021.

Please note that in March 2021, the New England Journal of Medicine published results from the phase III PEGASUS study, which evaluated pegcetacoplan for treating PNH. Data from the same showed that treatment with pegcetacoplan led to statistically superior increases in mean hemoglobin levels compared with

Alexion

’s

ALXN

blockbuster drug, Soliris (eculizumab). It also demonstrated substantial improvements in other key markers of disease in adult patients with PNH who had persistent anemia after being treated with Soliris at week 16.

Meanwhile, pegcetacoplan is also being evaluated in the phase III PRINCE study in treatment-naive PNH patients. Top-line data from the same is expected in the second quarter of 2021. The candidate is also being evaluated in two phase III studies, namely, DERBY and OAKS, for treating in patients with geographic atrophy. Top-line results from both studies are expected in the third quarter of 2021.

We note that, in March 2021, Apellis discontinued the additional development of investigational targeted C3 therapy, APL-9, designed for acute interventions for treating severe COVID-19 infection. The decision was taken following an interim review of mortality data from the phase I/II study by an independent data monitoring committee (“DMC”). Data from the same showed no meaningful reduction in the overall mortality rate in patients who were treated with APL-9 in combination with standard of care therapy versus standard of care alone. Also, no safety signal was observed by the DMC.

Zacks Rank & Stocks to Consider

Apellis currently carries a Zacks Rank #3 (Hold). Better-ranked stocks in the biotech sector include

ASLAN Pharmaceuticals Limited


ASLN

and

Nabriva Therapeutics AG


NBRV

, both carrying a Zacks Rank #2 (Buy) at present. You can see


the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here


.

ASLAN Pharmaceuticals’ loss per share estimates have narrowed 26.3% for 2021 and 43.9% for 2022 over the past 60 days. The stock has surged 82% year to date.

Nabriva Therapeutics’ loss per share estimates have narrowed 40.9% for 2021 and 45.3% for 2022 over the past 60 days.

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