On August 4, 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 second quarter and first half 2022 financial results and corporate updates (Press release, Iovance Biotherapeutics, AUG 4, 2022, View Source [SID1234617531]).

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Frederick Vogt, Ph.D., J.D., Interim President and Chief Executive Officer of Iovance, stated, "Iovance continues to solidify our global leadership across all three aspects of our mission to innovate, develop and deliver TIL therapy for patients with cancer. During the second quarter we executed toward our top priority, to submit the BLA for lifileucel in metastatic melanoma, while preparing for commercialization and advancing our robust immuno-oncology pipeline. Following our recent pre-BLA meeting in late July, we are finalizing our BLA to begin submission this month. With many opportunities to create significant value for cancer patients and our shareholders, Iovance is a true pioneer in the industry, driven by our experienced executive leadership team and talented organization with deep cell therapy experience."

Second Quarter 2022 Highlights and Recent Corporate Updates

Regulatory

Iovance TIL therapy (lifileucel) in metastatic melanoma (post-anti-PD-1): Iovance held a successful pre-BLA meeting with the U.S. Food and Drug Administration (FDA) in late July 2022. The FDA provided favorable feedback on the clinical efficacy data from Cohorts 2 and 4 of the C-144-01 clinical trial, including duration of follow up, and the potency assay matrix. The FDA agreed the clinical and safety dataset was sufficient for BLA review. Iovance will commence a rolling BLA submission for lifileucel in metastatic melanoma this month and complete the submission during the fourth quarter.
Clinical

Iovance TIL therapy (lifileucel) in metastatic melanoma:
Positive clinical data in advanced (post-anti-PD-1) metastatic melanoma: Iovance reported positive clinical data from the C-144-01 clinical trial and plans to present additional results at a medical meeting in the second half of 2022.
Frontline (anti-PD-1 naïve) metastatic melanoma: Iovance remains on track to open a Phase 3 trial of lifileucel in combination with pembrolizumab in frontline metastatic melanoma in late 2022. The trial is intended to expand the opportunity for lifileucel as an earlier treatment and serve as a confirmatory study for C-144-01 clinical trial Cohort 4.
Poster at American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting: A translational science poster highlighting the potential for lifileucel to benefit patients with melanoma regardless of immune checkpoint inhibitor (ICI) exposure and independent of tumor biomarkers of mutational burden, single-gene mutations, or inflammation.
Iovance TIL therapy (LN-145) in second-line mNSCLC: Enrollment is ongoing at more than 30 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.

First in human trial of genetically modified Iovance TIL therapy IOV-4001: site activation and patient recruitment are underway in the IOV-GM1-201 clinical trial of Iovance’s first genetically modified TIL therapy, IOV-4001, for the treatment of previously treated advanced melanoma or mNSCLC. IOV-4001 leverages the gene editing TALEN technology licensed from Cellectis to inactivate PD-1 expression.

Iovance TIL therapy (lifileucel) in advanced cervical cancer: Following FDA discussions and feedback on a registration strategy to address the shift in frontline standard of care, Iovance plans to reopen Cohort 2 of the ongoing C-145-04 trial to enroll additional patients who have received prior anti-PD-1 therapy. The expanded 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

Several targets for genetic modification using the gene-editing TALEN technology, including double genetic knock-out programs, are advancing in preclinical development.

Additional research and preclinical studies include approaches to increase TIL potency using CD39/69 double negative TILs and gene knock-in targets as well as development of a novel interleukin-2 (IL-2) analog (IOV-3001).
Manufacturing

The Iovance Cell Therapy Center (iCTC) is currently operating flex suites for clinical manufacturing and core suites for BLA readiness activities.

Iovance is building capacity to treat thousands of cancer patients annually, with capacity at iCTC for 2,000+ patients and flexibility to expand existing shell space to supply 5,000+ patients per year.
Corporate

Iovance entered into an amendment to its license agreement with the National Institutes of Health (NIH) to include additional exclusive, worldwide patent rights to TIL products expressing IL-12, expanded rights to TIL selection technologies, and additional non-exclusive, worldwide patent rights to certain technologies related to enhancing TIL potency.

Cash position of $430.9 million at June 30, 2022 is expected to be sufficient into 2024.

Iovance currently owns more than 50 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.
Second Quarter and First Half 2022 Financial Results

Iovance had $430.9 million in cash, cash equivalents, investments and restricted cash at June 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, we continue to maintain a strong balance sheet through prudent investments in commercial launch preparations, internal manufacturing and pipeline expansion. Our cash position is expected to take us through several milestones to create value for patients and shareholders."

Net loss for the second quarter ended June 30, 2022, was $99.3 million, or $0.63 per share, compared to a net loss of $81.4 million, or $0.53 per share, for the second quarter ended June 30, 2021. Net loss for the six months ended June 30, 2022, was $191.0 million, or $1.21 per share, compared to a net loss of $156.8 million, or $1.04 per share, for the same period ended June 30, 2021.

Research and development expenses were $73.4 million for the second quarter ended June 30, 2022, an increase of $11.3 million compared to $62.1 million for the same period ended June 30, 2021. Research and development expenses were $141.7 million for the six months ended June 30, 2022, an increase of $23.6 million compared to $118.1 million for the same period ended June 30, 2021.

The increases in research and development expenses in the second quarter and first half of 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 $26.3 million for the second quarter ended June 30, 2022, an increase of $7.0 million compared to $19.3 million for the same period ended June 30, 2021. General and administrative expenses were $49.7 million for the six months ended June 30, 2022, an increase of $10.8 million compared to $38.9 million for the same period ended June 30, 2021.

The increase in general and administrative expenses in the second quarter and first half of 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, 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/BI25a798dba7074946a0aa3082d603bf41. 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