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Iovance (IOVA) Q3 Earnings Beat Estimates, Pipeline in Focus

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Iovance Biotherapeutics, Inc. (IOVA - Free Report) incurred loss of 40 cents per share in third-quarter 2020, narrower than the Zacks Consensus Estimate of a loss of 46 cents. However, the bottom line was flat year over year.

In the absence of any marketed products and revenue generating collaborations, the company did not record any revenues during the quarter.

Iovance’s shares have gained 46.1% so far this year against the industry’s decrease of 2.2%.

Quarter in Detail

Research & development (R&D) expenses were $43.1 million, 3.6% higher than the year-ago quarter, primarily due to an increase in related personnel costs, partially offset by a decline in manufacturing costs.

General and administrative (G&A) expenses increased 59% to $15.9 million due to an increase in related personnel costs.

The company had $719.7 million in cash, cash equivalents, short-term investments and restricted cash as of Sep 30, 2020 compared with $777.4 million as of Jun 30, 2020.

Pipeline Update

Iovance is developing its lead pipeline candidate, lifileucel, as a monotherapy for treating metastatic melanoma and metastatic cervical cancer in pivotal studies. Two separate pivotal studies are currently evaluating the candidate.

In October, the company and the FDA agreed upon the duration of follow up for its pivotal Cohort 4 in a phase II study, evaluating the candidate in metastatic melanoma patients to support a biologics license application (“BLA”). The extension of duration for Cohort 4 in order to reach the required potency assays to fully define tumor-infiltrating lymphocyte (TIL), has delayed the BLA submission to 2021, which was previously expected by the end of 2020.

Meanwhile, the company completed dosing of the last patient in the pivotal Cohort 1 of another phase II study evaluating lifileucel metastatic cervical cancer.

A multi-cohort phase II study is evaluating lifileucel in multiple settings and indications.

New interim clinical data from a cohort of the study evaluating a combination regimen of lifileucel and Merck’s (MRK - Free Report) Keytruda achieved an overall response rate of 44% in head and neck squamous cell carcinoma patients who were not treated with a checkpoint inhibitor earlier.

Iovance announced that it has finalized a protocol for the potential registration-directed study, IOV-LUN-202, which will evaluate lifileucel in patients with recurrent or metastatic non-small cell lung cancer, without driver mutations and patients who previously received a single line of approved systemic therapy.

Zacks Rank & Stocks to Consider

Iovance currently has a Zacks Rank #4 (Sell).

A couple of better-ranked stocks from the biotech sector include Emergent Biosolutions (EBS - Free Report) and miRagen Therapeutics . While Emergent sports a Zacks Rank #1 (Strong Buy), miRagen carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Emergent Biosolutions’ earnings per share estimates have moved up from $6.17 to $8.42 for 2021 in the past 60 days. The company delivered an earnings surprise of 106.11%, on average, in the last four quarters. The stock has risen 71.1% so far this year.

Miragen Therapeutics’ loss per share estimates narrowed from 51 cents to 42 cents for 2021 in the past 60 days. The stock has risen 116.7% so far this year.

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Iovance Biotherapeutics, Inc. (IOVA) - free report >>