On November 3, 2022 Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a late-stage biotechnology company developing novel T cell-based cancer immunotherapies (tumor infiltrating lymphocyte, TIL, and peripheral-blood lymphocyte, PBL), reported third quarter and year-to-date 2022 financial results and corporate updates (Press release, Iovance Biotherapeutics, NOV 3, 2022, View Source [SID1234622954]).

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Frederick Vogt, Ph.D., J.D., Interim President and Chief Executive Officer of Iovance, stated, "Iovance has made tremendous progress year-to-date. With our rolling BLA submission for lifileucel and six active clinical trials of TIL therapy underway, we are executing our mission to innovate, develop and deliver TIL therapy for patients with cancer. We are on track to complete our BLA submission in the fourth quarter. As we prepare for our first potential FDA approval and commercial launch and advance our pipeline and technology platforms, we believe we have multiple opportunities to create significant value for patients with cancer as well as for our shareholders."

Third Quarter 2022 Highlights and Recent Corporate Updates

Regulatory and Clinical Updates for Iovance TIL Therapy (Lifileucel) in Advanced Melanoma

BLA Submission: A rolling BLA submission for lifileucel in advanced melanoma (post-anti-PD-1 therapy) commenced in August 2022 and is anticipated to complete in the fourth quarter of 2022.

C-144-01 Trial Presentation and Poster at Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper): Iovance reported positive topline clinical data from Cohorts 2 and 4 of the C-144-01 clinical trial in advanced melanoma in the second quarter of 2022. A pooled analysis and additional results for Cohorts 2 and 4 will be presented during SITC (Free SITC Whitepaper)’s 37th Annual Meeting as well as a Webcast on November 10, 2022.

Phase 3 trial in frontline advanced melanoma: Iovance remains on track to begin the Phase 3 trial of lifileucel in combination with pembrolizumab in frontline advanced melanoma in late 2022. The Phase 3 trial is intended to expand the opportunity for lifileucel as an earlier treatment and serve as a confirmatory study.

Poster at European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2022: A poster at ESMO (Free ESMO Whitepaper) highlighted the potential for lifileucel in advanced melanoma patients who progress after anti-LAG-3 and anti-PD-1 combination therapy. Lifileucel response rates were consistent between the overall C-144-01 study population and a C-144-01 subgroup analysis of patients treated with prior anti-LAG-3 containing therapy.
Manufacturing and Commercial Preparations

The Iovance Cell Therapy Center (iCTC) is currently operating flex suites for clinical manufacturing and core suites for activities to support BLA submission and review, including pre-approval inspections, in preparation for commercial supply.

The iCTC facility as currently built has annual capacity to supply TIL therapies for 2,000+ patients, with flexibility to build out existing shell space to supply 5,000+ patients.

Contract manufacturers provide additional flexibility and capacity for Iovance to meet potential commercial and clinical demand, including a new agreement for two cGMP manufacturing suites for commercial manufacturing and supply.

Iovance is executing several initiatives ahead of potential commercialization in 2023, including on-boarding and personnel training at authorized treatment centers (ATCs), education and awareness, and other launch readiness activities.
Clinical Pipeline

Iovance TIL therapy (LN-145) in mNSCLC: Enrollment is ongoing at more than 40 active clinical sites in the U.S., Canada and Europe for the IOV-LUN-202 trial of LN-145 in patients with mNSCLC. Iovance is engaged in discussions with the FDA about the potential for IOV-LUN-202 to serve as a registrational trial for LN-145 in mNSCLC and intends to execute an updated regulatory strategy based on this dialogue and feedback.

Iovance PD-1 inactivated TIL therapy (IOV-4001) in previously treated advanced melanoma or mNSCLC: the first patient was dosed, and completed the safety observation period, in the IOV-GM1-201 trial of IOV-4001, Iovance’s first genetically modified TIL therapy. To inactivate the gene coding for the PD-1 protein, IOV-4001 utilizes the gene editing TALEN technology licensed from Cellectis.

Lifileucel in advanced cervical cancer: Iovance expanded Cohort 2 of the ongoing C-145-04 trial to enroll additional patients. Following FDA discussions and feedback, Cohort 2 is intended to support a BLA in cervical cancer following progression on chemotherapy and pembrolizumab.
Research Programs for Next-Generation TIL Therapies and Related Technologies

Additional research and preclinical studies focused on optimizing TIL therapy consist of several targets for genetic modification using the gene-editing TALEN technology, including double genetic knock-out programs, as well as approaches to increase TIL potency using CD39/69 double negative TILs and gene knock-in targets that incorporate enhancements such as tethered cytokines.

A novel interleukin-2 (IL-2) analog (IOV-3001) is in IND-enabling studies supporting its use as part of the TIL treatment regimen following TIL infusion.
Corporate

Cash position of $366.6 million at September 30, 2022 is expected to be sufficient into 2024.

Iovance currently owns at least 60 granted or allowed U.S. and international patents for TIL compositions and methods of treatment and manufacturing in a broad range of cancers, with Gen 2 patent rights expected to provide exclusivity into 2038. More information on Iovance’s patent portfolio can be found on the Intellectual Property page on www.iovance.com.
Third Quarter and Year-to-Date 2022 Financial Results

Iovance had $366.6 million in cash, cash equivalents, investments and restricted cash at September 30, 2022, compared to $602.1 million at December 31, 2021. The cash position is expected to be sufficient to fund current and planned operations into 2024.

Jean-Marc Bellemin, Chief Financial Officer of Iovance, said, "As a late-stage oncology company approaching potential commercialization, our cash position continues to support our prudent investments in commercial launch preparations, internal manufacturing and pipeline expansion into several milestones to create value for patients and shareholders."

Net loss for the third quarter ended September 30, 2022, was $99.6 million, or $0.63 per share, compared to a net loss of $86.1 million, or $0.55 per share, for the third quarter ended September 30, 2021. Net loss for the nine months ended September 30, 2022, was $290.6 million, or $1.85 per share, compared to a net loss of $242.9 million, or $1.60 per share, for the same period ended September 30, 2021.

Research and development expenses were $72.5 million for the third quarter ended September 30, 2022, an increase of $7.1 million compared to $65.4 million for the same period ended September 30, 2021. Research and development expenses were $214.2 million for the nine months ended September 30, 2022, an increase of $30.8 million compared to $183.4 million for the same period ended September 30, 2021.

The increases in research and development expenses in the third quarter and year-to-date 2022 over the prior year periods were primarily attributable to growth of the internal research and development team, including stock-based compensation expense, as well as facility-related and internal research program costs, which were partially offset by lower clinical and manufacturing costs driven by completion of enrollment of pivotal clinical trials.

General and administrative expenses were $27.9 million for the third quarter ended September 30, 2022, an increase of $7.0 million compared to $20.9 million for the same period ended September 30, 2021. General and administrative expenses were $77.6 million for the nine months ended September 30, 2022, an increase of $17.8 million compared to $59.8 million for the same period ended September 30, 2021.

The increase in general and administrative expenses in the third quarter and year-to-date 2022 compared to the prior year periods were primarily attributable to growth of the internal general and administrative and commercial teams, including stock-based compensation expense, and facility-related costs associated with the build-out of the new corporate headquarters, as well as costs associated with pre-commercial activities.

For additional information, please see the Company’s Selected Condensed Consolidated Balance Sheet and Statement of Operations below.

Webcast and Conference Call

To participate in the conference call, please register at https://register.vevent.com/register/BI4721983fb77a4615b46f4ab97c051712. The live and archived webcast can be accessed in the Investors section of the Company’s website, IR.Iovance.com. The archived webcast will also be available for one year.