On August 1, 2019 Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a late-stage biotechnology company developing novel cancer immunotherapies based on tumor-infiltrating lymphocyte (TIL) technology, reported financial results from second quarter and first six months of 2019 and provided a corporate update (Press release, Iovance Biotherapeutics, AUG 1, 2019, View Source [SID1234538014]).
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"We have had a highly productive second quarter at Iovance," commented Maria Fardis, Ph.D., MBA, president and chief executive officer of Iovance Biotherapeutics. "We presented data for both melanoma and cervical programs at ASCO (Free ASCO Whitepaper), met with the FDA to define our registration path for LN-145, received Breakthrough Therapy Designation for LN-145, and broke ground for our commercial manufacturing facility. Based on FDA feedback, we expect to submit a Biologics License Application (BLA) for LN-145 for advanced cervical cancer in late 2020. This time frame potentially overlaps with the expected timing of a submission in the advanced melanoma indication. In addition, we continue to expand the Iovance team and build our corporate infrastructure in anticipation of making TIL therapy broadly accessible to all patients that may benefit from this treatment approach."
Recent Achievements and Upcoming Milestones
Clinical
.Data from the C-144-01 melanoma study and from the C-145-04 cervical cancer study were presented in June 2019 at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting. Data from the C-145-04 study in 27 patients demonstrated an objective response rate (ORR) of 44 percent. At 7.4-month median follow-up, the median duration of response (DOR) had not been reached. Interim results from the C-144-01 study in 66 patients demonstrated an ORR of 38 percent. At 8.8-month median follow-up, median DOR had not been reached.
·Enrollment for Cohort 4, the pivotal cohort of the C-144-01, is on target for completion of enrollment in the first quarter of 2020.
·Study C-145-04 has been expanded to dose 75 patients to address the expected sample size in anticipation of a BLA submission in late 2020.
·The first patient has been dosed in the IOV-COM-202 study evaluating TIL monotherapy or TIL plus pembrolizumab in patients with melanoma, head and neck cancer, or non-small cell lung cancer (NSCLC). The company has amended the protocol for IOV-COM-202 to add an additional cohort to treat PD-1 naive NSCLC patients with TIL and pembrolizumab. The total number of patients expected to enroll in the study was increased to 48. This study has received regulatory approval for conduct in EU and Canada.
·To date, over 200 patients have been treated with TIL therapy at Iovance.
Regulatory
·In May 2019, LN-145 was granted Breakthrough Therapy designation from the U.S. Food and Drug Administration (FDA) for the treatment of advanced cervical cancer patients who have progressed during or after chemotherapy.
·At an End of Phase 2 meeting, the FDA acknowledged that the ongoing C-145-04 study of TIL therapy LN-145 may be sufficient to support registration in the treatment of patients with advanced cervical cancer. We plan to include in the BLA, patients who have progressed following initial systemic therapy for recurrent or metastatic disease, which constitutes almost all of the more advanced patients enrolled to date. The protocol may further be amended to enroll additional patients in order to support a BLA submission.
Research
·A poster entitled "Iovance Peripheral Blood Lymphocytes (PBL): A Potential Cell Therapy Strategy for the Treatment of Chronic Lymphocytic Leukemia" was presented at the 24th Congress of European Hematology Association (EHA) (Free EHA Whitepaper) in June 2019. The poster described the company’s nine-day manufacturing process and preclinical results for IOV-2001, PBL for chronic lymphocytic leukemia, created from 50 mL of blood.
·In July 2019, the company entered into a clinical trial agreement with the University of Montreal Health Centre (CHUM), under which CHUM will conduct a clinical study that it has designed using PD-1 positive selected TIL. The PD-1 positive TIL to be used in the study will be manufactured by a GMP cell processing facility within the University of Montreal network using a process developed by CHUM. Iovance also has an option to negotiate an exclusive license to the technology from CHUM. Iovance is expanding its footprint in Canada with this collaboration.
Corporate
·In May 2019, the company entered into a long-term lease agreement to build an approximately 136,000 square foot commercial-scale production facility in Philadelphia for commercial and clinical production of autologous TIL products. The company and its partners began construction of the facility in June 2019.
·Friedrich Graf Finckenstein, M.D., joined the company as chief medical officer.
·Athena Countouriotis, M.D., was appointed to the company’s board of directors.
·The company currently owns seven recently granted or allowed U.S. patents for compositions and methods of treatment in a broad range of cancers relating to its Gen 2 manufacturing process, including U.S. Patent Nos. 10,166,257, 10,130,659, and 10,272,113. The company’s owned and licensed intellectual property portfolio also includes patent applications relating to TIL, marrow infiltrating lymphocyte, and PBL therapies; methods of manufacturing; the use of costimulatory molecules in TIL therapy and manufacturing; stable and transient genetically-modified TIL therapies; and methods of treating patient subpopulations.
Second Quarter 2019 Financial Results
Net loss for the second quarter ended June 30, 2019, was $47.6 million, or $0.38 per share, compared to net loss of $30.7 million, or $0.34 per share for the second quarter ended June 30, 2018.
Research and development expenses were $39.3 million for the second quarter of 2019, an increase of $14.7 million compared to $24.6 million for the second quarter of 2018. The increase in research and development expenses was primarily attributable to costs associated with the transfer of the manufacturing process to additional facilities to increase our manufacturing capacity, an increase in total patients in our clinical studies which in turn resulted in higher study costs, and an increase in research and development employees.
General and administrative expenses were $10.9 million for the second quarter of 2019, an increase of $4.1 million compared to $6.8 million for the second quarter of 2018. The increase was primarily attributable to new general and administrative employees and higher stock-based compensation, legal expenses related to the intellectual property portfolio and real estate and external market research costs as we prepare for commercialization.
Six Months Ended June 30, 2019 Financial Results
Net loss for the six months ended June 30, 2019, was $84.5 million, or $0.68 per share, compared to net loss of $57.2 million, or $0.65 per share for the same period ended June 30, 2018.
Research and development expenses were $70.2 million for the six months ended June 30, 2019, an increase of $25.7 million compared to $44.5 million for the same period ended June 30, 2018. The increase in research and development expenses was primarily attributable to costs associated with the transfer of the manufacturing process to additional facilities to increase our manufacturing capacity, higher costs for drugs used in the clinical studies, an increase in total patients in our clinical studies which in turn resulted in higher study costs, and an increase in the number of research and development employees.
General and administrative expenses were $19.9 million for the six months ended June 30, 2019, an increase of $6.1 million compared to $13.8 million for the same period ended June 30, 2018. The increase was primarily attributable to the addition of general and administrative employees and higher stock-based compensation, legal expenses related to intellectual property, and external market research expenses.
Cash, Cash Equivalents, Short-Term Investments and Restricted Cash
At June 30, 2019, the company held $409.6 million in cash, cash equivalents, short-term investments and restricted cash as compared to $440.0 million at March 31, 2019. During the second quarter the company used $33.8 million for operating activities. The company anticipates that the year-end balance of cash, cash equivalents, short-term investments and restricted cash may be between $310 and $320 million.
Webcast and Conference Call
Iovance will host a conference call and live audio webcast to discuss financial results and provide a corporate update today at 4:30 p.m. EDT.
To participate in the conference call, please dial 1-844-646-4465 (domestic) or 1-615-247-0257 (international) and reference the access code 7574927. A live and archived webcast can be accessed in the Investors section of the company’s website at www.iovance.com.