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Iovance (IOVA) Reports Wider-Than-Anticipated Loss in Q3
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Iovance Biotherapeutics, Inc. (IOVA - Free Report) incurred a loss of 55 cents per share for third-quarter 2021, wider than the Zacks Consensus Estimate of a loss of 52 cents and the year-ago loss of 40 cents.
In the absence of any marketed products and revenue-generating collaborations, the company did not record any revenues during the quarter.
Shares of Iovance have plunged 47.2% so far this year in comparison with the industry’s 6.9% decrease.
Image Source: Zacks Investment Research
Quarter in Detail
Research & development expenses were $65.4 million, 51.8% higher than the year-ago quarter, primarily due to an increase in related personnel costs and facility building costs.
General and administrative expenses increased 31.2% from the prior-year quarter to $20.9 million due to an increase in related personnel costs.
The company had $660.8 million in cash, cash equivalents, short-term investments and restricted cash as of Sep 30, 2021 compared with $708.7 million on Jun 30, 2021.
It expects the cash level to be sufficient to fund the current and planned operations into 2023.
Pipeline Updates
Iovance is developing its lead pipeline candidate, lifileucel, as a monotherapy for treating metastatic melanoma and metastatic cervical cancer in separate pivotal studies. Currently, the company is developing lifileucel in separate pivotal phase II studies — C-144-01 and C-145-04 — for metastatic melanoma, and recurrent, metastatic or persistent cervical cancer, respectively, in previously-treated patients.
Following FDA concerns over potency assays for lifileucel, Iovance plans to submit additional assay data to the FDA later in 2021. Following a potential resolution, the company plans to submit a biologics license application (BLA) for lifileucel for the treatment of melanoma in first-half 2022. A resolution for the potential assay for lifileucel will also help Iovance to proceed with its regulatory plans for other indications.
In May 2021, Iovance announced plans to continue the ongoing work of developing and validating its potency assays for lifileucel following feedback from the FDA on its previously-submitted assay data. The company plans to submit additional assay data to the FDA later in 2021, with a potential BLA submission for lifileucel for melanoma planned in first-half 2022.
Iovance is also evaluating another tumor-infiltrating lymphocyte (TIL) therapy, LN-145, as a potential treatment for head and neck squamous cell carcinoma and non-small cell lung cancer in two separate studies.
A multi-center phase II study — IOV-COM-202 — composed of seven cohorts is evaluating Iovance’s TIL therapies in multiple settings and indications, both as a monotherapy and in combination with Merck’s (MRK - Free Report) Keytruda or Bristol-Myers’ (BMY - Free Report) Opdivo/Yervoy.
The company is also progressing well with IND-enabling studies including a novel IL-2 analog (IOV-3001) and a genetically modified TIL (IOV-4001). IOV-4001 leverages the TALEN technology licensed from Cellectis S.A. (CLLS - Free Report) to genetically knock out PD-1 in TIL cells.
Image: Bigstock
Iovance (IOVA) Reports Wider-Than-Anticipated Loss in Q3
Iovance Biotherapeutics, Inc. (IOVA - Free Report) incurred a loss of 55 cents per share for third-quarter 2021, wider than the Zacks Consensus Estimate of a loss of 52 cents and the year-ago loss of 40 cents.
In the absence of any marketed products and revenue-generating collaborations, the company did not record any revenues during the quarter.
Shares of Iovance have plunged 47.2% so far this year in comparison with the industry’s 6.9% decrease.
Quarter in Detail
Research & development expenses were $65.4 million, 51.8% higher than the year-ago quarter, primarily due to an increase in related personnel costs and facility building costs.
General and administrative expenses increased 31.2% from the prior-year quarter to $20.9 million due to an increase in related personnel costs.
The company had $660.8 million in cash, cash equivalents, short-term investments and restricted cash as of Sep 30, 2021 compared with $708.7 million on Jun 30, 2021.
It expects the cash level to be sufficient to fund the current and planned operations into 2023.
Pipeline Updates
Iovance is developing its lead pipeline candidate, lifileucel, as a monotherapy for treating metastatic melanoma and metastatic cervical cancer in separate pivotal studies. Currently, the company is developing lifileucel in separate pivotal phase II studies — C-144-01 and C-145-04 — for metastatic melanoma, and recurrent, metastatic or persistent cervical cancer, respectively, in previously-treated patients.
Following FDA concerns over potency assays for lifileucel, Iovance plans to submit additional assay data to the FDA later in 2021. Following a potential resolution, the company plans to submit a biologics license application (BLA) for lifileucel for the treatment of melanoma in first-half 2022. A resolution for the potential assay for lifileucel will also help Iovance to proceed with its regulatory plans for other indications.
In May 2021, Iovance announced plans to continue the ongoing work of developing and validating its potency assays for lifileucel following feedback from the FDA on its previously-submitted assay data. The company plans to submit additional assay data to the FDA later in 2021, with a potential BLA submission for lifileucel for melanoma planned in first-half 2022.
Iovance is also evaluating another tumor-infiltrating lymphocyte (TIL) therapy, LN-145, as a potential treatment for head and neck squamous cell carcinoma and non-small cell lung cancer in two separate studies.
A multi-center phase II study — IOV-COM-202 — composed of seven cohorts is evaluating Iovance’s TIL therapies in multiple settings and indications, both as a monotherapy and in combination with Merck’s (MRK - Free Report) Keytruda or Bristol-Myers’ (BMY - Free Report) Opdivo/Yervoy.
The company is also progressing well with IND-enabling studies including a novel IL-2 analog (IOV-3001) and a genetically modified TIL (IOV-4001). IOV-4001 leverages the TALEN technology licensed from Cellectis S.A. (CLLS - Free Report) to genetically knock out PD-1 in TIL cells.
Iovance Biotherapeutics, Inc. Price
Iovance Biotherapeutics, Inc. price | Iovance Biotherapeutics, Inc. Quote
Zacks Rank
Iovance currently has a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.