Iovance (IOVA) Q4 Earnings In Line With Estimates, Revenues Nil
Iovance Biotherapeutics, Inc. IOVA incurred a loss of 64 cents per share in fourth-quarter 2022, in line with the Zacks Consensus Estimate. The quarterly earnings beat our model estimates of 68 cents. In the year-ago quarter, the company reported a loss of 63 cents.
Without any marketed product and revenue-generating collaboration, the company did not record any revenues during the quarter.
Shares of Iovance have lost 52.8% in the past year compared with the industry’s 11.0% fall.
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Quarter in Detail
Research & development expenses were $80.6 million, up 6.6% from the year-ago quarter’s levels, primarily due to increased related personnel and facility building costs.
General and administrative expenses increased 11.0% from the prior-year quarter’s figure to $26.5 million due to an increase in related personnel costs and facility-related costs.
The company had $478.3 million in cash, cash equivalents, short-term investments and restricted cash as of Dec 31, 2022, compared with $366.6 million on Sep 30, 2022.
Iovance has also raised $450 in net proceeds from ATM equity financing during the fourth-quarter 2022 and first-quarter 2023. Based on the cash position, management expects to fund the company’s current and planned operations into second-half 2024.
Full-Year Results
Iovance did not report any revenues for the full year. The company incurred a loss of $2.49 per share for 2022 compared with a loss of $2.23 in the year-ago period.
Proleukin Acquisition
In January, Iovance announced that it has entered into an in-licensing agreement with U.K.-based Clinigen Limited for the latter’s interleukin-2 (IL-2) product, Proleukin (aldesleukin). Per the terms of the agreement, the company will acquire worldwide rights to this drug. Currently, Proleukin is approved by the FDA for treating two cancer indications in adults –mRCC and metastatic melanoma.
Considering these rights, Clinigen will get an upfront payment of £166.7 million from Iovance and be eligible to receive double-digit royalties on global Proleukin sales. The transaction is expected to close by the end of first-quarter 2023 or early second-quarter 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 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.
Last August, Iovance initiated a rolling biologics license application (BLA) submission for lifileucel in melanoma indication, which is expected to be completed by the end of first-quarter 2023. If the BLA is approved, lifileucel will be the first FDA-approved individualized, one-time cell therapy for melanoma patients. It will also be Iovance’s first-ever therapy to receive FDA approval. The BLA filing is supported by data from the pivotal Cohort 4 of the C-144-01 study, wherein patients treated with the therapy achieved an objective response rate (ORR) of 29%.
IOVA has also recently started the phase III TILVANCE-301 study to evaluate the combination of lifileucel and Merck’s MRK PD-L1 inhibitor, Keytruda (pembrolizumab) in frontline advanced melanoma. This late-stage study will also serve as a confirmatory study for the pivotal Cohort 4 of the C-144-01 study.
Other than lifileucel, Iovance is also evaluating another TIL therapy, LN-145, as a potential treatment for head and neck squamous cell carcinoma (HNSCC) and non-small cell lung cancer (NSCLC) in two separate mid-stage studies, C-145-01 and IOV-LUN-202, respectively. Management is currently in discussion with the FDA to determine if IOV-LUN-202 can serve as a registrational study for LN-145 to address second-/third-line metastatic NSCLC.
Another ongoing phase II study, IOV-COM-202, composed of seven cohorts, is evaluating Iovance’s TIL therapies in multiple settings and for several indications, as a monotherapy and in combination with Merck’s Keytruda or Bristol Myers’ Opdivo/Yervoy.
In January, management reported positive data from cohort 3A of the IOV-COM-202 study, which evaluated LN-145 plus Merck’s Keytruda in anti-PD-1 naïve metastatic NSCLC. Data from this cohort demonstrated an ORR of 47%. Management plans to discuss these results with the FDA later this year and plans to start a registrational study evaluating lifileucel in frontline advanced NSCLC.
Iovance Biotherapeutics, Inc. Price
Iovance Biotherapeutics, Inc. price | Iovance Biotherapeutics, Inc. Quote
Zacks Rank & Stocks to Consider
Iovance currently has a Zacks Rank #3 (Hold). A couple of better-ranked stocks in the overall healthcare sector include Allogene ALLO and Amarin Corporation AMRN, each carrying a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Allogene’s stock has declined 26.1% in the past year. Allogene’s loss estimates for 2023 have narrowed from $2.84 to $2.83 per share in the past 60 days.
Allogene beat earnings estimates in each of the last four quarters, the average surprise being 8.33%. In the last reported quarter, the company delivered an earnings surprise of 7.04%.
Amarin’s stock has declined 36.4% in the trailing 12 months. Amarin’s loss estimates for 2023 narrowed from 8 cents per share to 6 cents in the past 60 days.
Amarin beat earnings estimates in two of the last four quarters and missed the mark on the other two occasions, the average negative surprise being 14.29%. In the last reported quarter, Amarin’s earnings beat estimates by 200.00%.
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