On August 6, 2020 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 2020 financial results and provided a corporate update.
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"During a strong first half of 2020 we completed dosing and reported early data for our pivotal melanoma program for lifileucel, announced data at AACR (Free AACR Whitepaper) for our collaborator Moffitt’s TIL in non-small cell lung cancer, presented updated Cohort 2 data for lifileucel at ASCO (Free ASCO Whitepaper), and successfully completed a public financing," said Maria Fardis, Ph.D., MBA, Iovance President and Chief Executive Officer. "Iovance is now in an excellent position to execute our planned commercial launch while broadening our pipeline programs. The cumulative set of positive clinical data for lifileucel continue to support our planned BLA submission for this one-time treatment for metastatic melanoma. We are also pleased to report that our cervical cancer pivotal program has recently completed enrollment in Cohort 1, and we look forward to dosing the last few patients in the coming weeks. With the first potential cell therapy in solid tumors and a broadening TIL platform, we believe Iovance is the leader in development, manufacturing, and commercialization of TIL cell therapy for cancer."
Second Quarter 2020 Updates
Clinical:
·TIL therapy, lifileucel, in Melanoma: updated data from the C-144-01 trial continue to support the potential for lifileucel as a one-time treatment for advanced melanoma.
oUpdated Cohort 2 data presented at ASCO (Free ASCO Whitepaper) 2020 showed an ORR of 36.4% with median duration of response not reached at 18.7 months of median study follow up (n=66).
Early Cohort 4 data showed 32.4% ORR at 5.3 months of median study follow up (n=68).
·TIL therapy, lifileucel, in Cervical cancer: enrollment in the pivotal Cohort 1 is complete in the C-145-04 study of lifileucel, previously known as LN-145, for advanced cervical cancer.
·TIL therapy in non-small cell lung cancer (NSCLC): active planning is underway for a registration-directed study, IOV-LUN-202, for LN-145 in NSCLC patients with defined unmet medical need.
·T-cell based therapies in additional indications: patient recruitment continues in the IOV-COM-202 basket study in solid tumors as well as the C-145-03 study in squamous cell carcinoma of the head and neck (SCCHN). Additional sites are being activated for the IOV-CLL-01 study in relapsed or refractory chronic lymphocytic leukemia and small lymphocytic lymphoma (CLL/SLL).
Regulatory:
·Iovance continues preparing for submission of a Biologics License Application (BLA) in late 2020 through data compilation and internal readiness activities.
·Iovance scheduled a meeting with U.S. FDA Division of Manufacturing and Product Quality (DMPQ) to align on the commercial manufacturing facility design and capacity. Full alignment was reached with the DMPQ prior to the upcoming scheduled meeting with the division.
·United States Adopted Names (USAN) council accepted and published the use of the name "lifileucel" to describe Iovance TIL therapy for cervical cancer in addition to melanoma. Lifileucel will replace the former product code LN-145 for the cervical cancer indication.
Commercial Launch Planning:
·Iovance is committed to providing individualized support for a personalized therapy through IovanceCaresTM, a program that will allow communication and coordination with health care providers (HCPs) for patient care throughout the lifileucel journey. All elements of the system will be managed by dedicated Iovance case managers to handle the needs of HCPs and patients. This platform will allow the hospitals to place orders for lifileucel, with Iovance to monitor and track patients’ cells during the manufacturing process through the delivery of lifileucel to the hospitals. The system will also include reimbursement support for sites.
Manufacturing:
·Construction of the Iovance Cell Therapy Center (iCTC) at the Navy Yard in Philadelphia remains on schedule. Clean rooms are expected to be completed in late 2020 with clinical activities to initiate in early 2021. Commercial manufacturing is on track for 2022.
Research:
·Entered into an agreement with Avid Bioservices for the GLP and GMP manufacturing of novel IL-2 analog IOV-3001.
Corporate:
·Cash position of $777.4 million at June 30 includes net proceeds of $567.4 million from a common stock public offering in June 2020. The current cash position is sufficient for Iovance to execute commercial launch and pipeline activities including a clinical program in NSCLC.
·A strong and growing organization of over 200 employees is in place across multiple locations, including an experienced commercial team with extensive cell therapy experience preparing for launch of lifileucel.
·Iovance has been granted a total of 12 U.S. patents for compositions and methods of treatment in using Iovance TIL in a broad range of cancers related to its 22-day second generation (Gen 2) manufacturing process.
Upcoming Data Presentations:
·Three Abstracts Accepted for ESMO (Free ESMO Whitepaper) Virtual Congress 2020: the following three posters will be highlighted at the upcoming ESMO (Free ESMO Whitepaper) Virtual Congress 2020, Scientific Weekend, to be held September 19-21, 2020
oIn vivo persistence of Iovance tumor-infiltrating lymphocytes LN-145 in cervical cancer patients (Abstract #3688)
oGenetic Modification of Iovance’s TIL through TALEN-mediated knockout of PD-1 as a strategy to empower TIL therapy for cancer (Abstract #3721)
oIovance Generation-2 Tumor-infiltrating Lymphocyte (TIL) Product Is Reinvigorated During the Manufacturing Process (Abstract #4229)
Second Quarter and First Half 2020 Financial Results
At June 30, 2020, Iovance held $777.4 million in cash, cash equivalents, short-term investments and restricted cash compared to $312.5 million at December 31, 2019. The current cash position includes net proceeds of $567.4 million from a common stock public offering in June 2020. The company anticipates that the year-end balance of cash, cash equivalents, short-term investments and restricted cash may be over $630 million. The operating expenses in the second half of 2020 are forecasted to be in the same range as the first half of 2020.
Net loss for the second quarter ended June 30, 2020, was $63.0 million, or $0.47 per share, compared to a net loss of $47.6 million, or $0.38 per share, for the second quarter ended June 30, 2019. Net loss for the six months ended June 30, 2020, was $132.6 million, or $1.02 per share, compared to a net loss of $84.5 million, or $0.68 per share, for the same period ended June 30, 2019.
Research and development expenses were $49.3 million for the second quarter ended June 30, 2020, an increase of $10.0 million compared to $39.3 million for the second quarter ended June 30, 2019. Research and development expenses were $106.2 million for the six months ended June 30, 2020, an increase of $36.0 million compared to $70.2 million for the same period ended June 30, 2019.
The increase in research and development expenses in the second quarter 2020 over the prior year period was primarily attributable to an increase in costs associated with multiple clinical trials, and growth of the internal research and development team. The increase in research and development expenses in the first half 2020 over the prior year period was primarily attributable to higher patient enrollment in clinical trials, licensing fees and growth of the internal research and development team.
General and administrative expenses were $14.4 million for the second quarter ended June 30, 2020, an increase of $3.5 million compared to $10.9 million for the second quarter ended June 30, 2019. General and administrative expenses were $28.2 million for the six months ended June 30, 2020, an increase of $8.3 million compared to $19.9 million for the same period ended June 30, 2019.
The increases in general and administrative expenses in the second quarter and first half 2020 compared to the prior year periods were primarily attributable to growth of the internal general and administrative team and higher stock-based compensation expenses.
Webcast and Conference Call
Iovance will host a conference call today at 4:30 p.m. ET to discuss the second quarter 2020 financial results and to provide a corporate update. The conference call dial-in numbers are 1-844-646-4465 (domestic) or 1-615-247-0257 (international). The conference ID access number for the call is 7875997. The live webcast can be accessed in the Investors section of the company’s website at View Source The archived webcast will be available for a year in the Investors section at www.iovance.com.