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Iovance (IOVA) Q4 Earnings Miss Estimates, Pipeline in Focus

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Iovance Biotherapeutics, Inc. (IOVA - Free Report) incurred loss of 47 cents per share in fourth-quarter 2020, wider than the Zacks Consensus Estimate of a loss of 46 cents. However, the bottom line narrowed from a loss of 50 cents per share in the year-ago quarter.

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

Shares of Iovance were down 1.9% in after-market trading on Feb 25 following the earnings release. The stock has however gained 10.6% in the past year compared with the industry’s increase of 15.9%.

Quarter in Detail

Research & development (R&D) expenses were $52.4 million, 3.3% lower than the year-ago quarter, primarily due to lower manufacturing and clinical costs following the completion of enrollment in the pivotal cohorts for melanoma and cervical cancer studies.

General and administrative (G&A) expenses increased 47.9% to $16.1 million due to an increase in related personnel costs.

The company had $635 million in cash, cash equivalents, short-term investments and restricted cash as of Sep 30, 2020 compared with $719.7 million as of Sep 30, 2020.

Full-Year Results

Iovance did not report any revenues for the full year. The company incurred loss of $1.88 per share for 2020, compared with a loss of $1.59 per share in the year-ago period.

Pipeline Update

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

Per a corporate update from the company last month, median duration of response has not been reached in cohort 2 of the C-144-01 study after median study follow up of 28.1 months evaluating lifileucel in metastatic melanoma patients.

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 company and the FDA are yet to reach an agreement on the potency assays to fully define tumor-infiltrating lymphocyte (TIL). However, the company anticipates to file a BLA in 2021.

Meanwhile, the company completed enrollment in the pivotal cohort 1 as well as cohort 2 of another phase II study — C-145-04 — evaluating lifileucel in metastatic cervical cancer. While cohort 1 is evaluating lifileucel in patients treated with chemotherapy, cohort 2 evaluating it in patients previously treated with anti-PD-1/PDL-1 therapies.

A multi-cohort phase II study — IOV-COM-202 — is evaluating lifileucel in multiple settings and indications in combination with Merck’s (MRK - Free Report) Keytruda or Bristol-Myers’ (BMY - Free Report) Opdivo/Yervoy. New interim clinical data from a cohort of the study evaluating a combination regimen of lifileucel and Keytruda, announced in November 2020, showed that the regimen achieved an overall response rate of 44% in head and neck squamous cell carcinoma (HNSCC) patients who were not treated with a checkpoint inhibitor earlier.

During the reported quarter, the company completed enrollment in a phase II study — C-145-03 — evaluating lifileucel in HNSCC patients.

Zacks Rank & Stocks to Consider

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

Lexicon Pharmaceuticals, Inc. (LXRX - Free Report) is a better-ranked stock to consider from the drug sector carrying a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Lexicon’s loss per share estimates have narrowed from 63 cents to 17 cents for 2021 in the past 60 days. The company delivered an earnings surprise of 21.72%, on average, in the last four quarters. The stock has risen 170% in the past year.

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