On November 4, 2020 Harpoon Therapeutics, Inc. (Nasdaq: HARP), a clinical-stage immunotherapy company developing a novel class of T cell engagers, reported financial results for the third quarter ended September 30, 2020 and provided a corporate update (Press release, Harpoon Therapeutics, NOV 4, 2020, View Source [SID1234569994]).
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"We continue to be excited by the advancement of our novel TriTAC pipeline, and are planning for our fourth program, HPN328, to enter the clinic this year for the treatment of DLL3-expressing tumors including small cell lung cancer," said Gerald McMahon, Ph.D., President and Chief Executive Officer of Harpoon Therapeutics. "Additionally, we expect to advance our HPN424, HPN536, and HPN217 clinical programs in the fourth quarter and present preclinical data at SITC (Free SITC Whitepaper) for our first ProTriTAC development program, HPN601, for the treatment of solid tumor malignancies."
Third Quarter 2020 Business Highlights and Other Recent Developments
Harpoon remains on track to initiate a Phase 1/2 clinical trial for HPN328 in the fourth quarter, which will be our fourth TriTAC in clinical development. HPN328 targets Delta-like canonical Notch ligand 3 (DLL3) for the treatment of small cell lung cancer (SCLC) and other DLL3-expressing tumors.
Harpoon has nominated its first ProTriTAC product candidate, HPN601, which targets epithelial cell adhesion molecule (EpCAM), and is applicable to a wide array of solid tumors. ProTriTACs have the potential for additional tumor specificity and enhanced safety profiles due to limited interaction with their molecular targets in healthy tissue, which enables targeting tumor-associated antigens that may be more broadly expressed. Furthermore, a HPN601 preclinical data abstract has been selected for an oral presentation at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) annual meeting on November 12.
Harpoon continues to expand the expertise within its executive team. In August, Harpoon appointed Karin Ann Thacker, M.Sc., as Vice President, Regulatory Affairs and Quality Assurance. In October, Harpoon appointed Omer Siddiqui as Vice President, Development Operations and Program Management. Both Ms. Thacker and Mr. Siddiqui are recognized R&D leaders in oncology across both early and late-stage clinical development.
In July, Harpoon appointed Joanne Viney, Ph.D., to its board of directors as an independent board member. Dr. Viney is an entrepreneurial scientist and experienced biotech executive with deep autoimmune and inflammatory disease expertise and currently serves as President, CSO and Co-founder of Pandion Therapeutics.
Third Quarter 2020 Financial Results
Harpoon ended the third quarter of 2020 with $162.3 million in cash, cash equivalents, and marketable securities compared to $155.1 million as of December 31, 2019. The increase was due primarily to a $50.0 million milestone payment received from AbbVie in the second quarter, partially offset by cash used in operations.
Revenue for the third quarter ended September 30, 2020 was $3.9 million compared to $1.4 million for the third quarter ended September 30, 2019. For the nine months ended September 30, 2020, revenue was $10.0 million compared to $3.5 million for the nine months ended September 30, 2019. During both the three and nine month periods, the increase in revenue was primarily due to revenue recognized from the development and option agreement with AbbVie, signed in November 2019.
Research and development (R&D) expense for the third quarter ended September 30, 2020 was $13.1 million compared to $9.5 million for the third quarter ended September 30, 2019. For the nine months ended September 30, 2020, R&D expense was $37.5 million, compared to $28.9 million for the nine months ended September 30, 2019. The increase for both periods primarily arose from higher clinical development and personnel-related expense, which included conducting preclinical studies and the continuation and preparation of the clinical trials for HPN424, HPN536, HPN217 and HPN328. These higher expenses were offset by a decrease in manufacturing costs due to a scale up of manufacturing activities in 2019 compared to 2020 to support our four TriTAC product candidates in various stages of development.
General and administrative (G&A) expense for the third quarter ended September 30, 2020 was $4.4 million compared to $8.5 million for the third quarter ended September 30, 2019. G&A expense for the nine months ended September 30, 2020 was $12.3 million compared to $18.1 million for the nine months ended September 30, 2019. For the third quarter ended September 30, 2020, the decrease was primarily attributable to a decrease in legal expenses associated with the Maverick litigation, partially offset by an increase in personnel expenses due to an increase in headcount. For the nine months ended September 30, 2020, the decrease was primarily attributable to a decrease in legal expenses associated with Maverick litigation, partially offset by an increase in personnel expenses related to an increase in headcount and other professional services to support our operations as a public company.
Net loss for the third quarter ended September 30, 2020 was $13.3 million compared to $15.9 million for the third quarter ended September 30, 2019. The net loss for the nine months ended September 30, 2020 was $38.6 million compared to $41.3 million in the first nine months of the prior year.
COVID-19 Business Update
In response to the ongoing COVID-19 pandemic, Harpoon has established testing and other protocols for personnel access to its headquarter offices and laboratory although substantially all of the company’s employees continue to telecommute. Harpoon is currently continuing its clinical trials it has underway at sites in the United States, and has not yet experienced any material delays or impacts as a result of the pandemic. In addition, Harpoon’s third-party contract manufacturers continue to operate at or near normal levels. Harpoon continues to assess the potential impact of the COVID-19 pandemic on its business and operations, including its programs, expected timelines, expenses, manufacturing activities and preclinical and clinical trials. The full extent to which the COVID-19 pandemic may have a negative impact on Harpoon’s business, assets, results of operations and financial condition will depend on future developments that are highly uncertain and cannot be accurately predicted.