On November 10, 2021 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, 2021 and provided a corporate update (Press release, Harpoon Therapeutics, NOV 10, 2021, View Source [SID1234595216]).

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"I look forward to working with the leadership team at Harpoon as we advance our novel immuno-oncology therapies to address the unmet medical needs of patients. We are encouraged by the clinical progress for our four proprietary TriTAC clinical programs, and we are excited to advance our ProTriTAC platform and to announce our third technology platform called TriTAC-XR at SITC (Free SITC Whitepaper)," said Julie Eastland, newly appointed President and Chief Executive Officer of Harpoon Therapeutics. "We remain focused on dose escalation and optimization across all four programs, and we plan to provide a corporate update by year end."

Third Quarter 2021 Business Highlights and Other Recent Developments

Harpoon recently appointed Julie Eastland as President and Chief Executive Officer, effective November 8, 2021. Ms. Eastland succeeds Jerry McMahon, Ph.D., who has resigned from his position as President and Chief Executive Officer and as a member of the company’s Board of Directors and will continue to serve as an advisor. Ms. Eastland joined the Harpoon Board in 2018 and her career spans more than 20 years of executive leadership in biotechnology, immunology, and clinical oncology.

Dose escalation for Harpoon’s four clinical stage programs, HPN424 (PSMA), HPN536 (mesothelin), HPN217 (BCMA) and HPN328 (DLL3) is ongoing and each program is enrolling patients. IND enabling studies are underway for HPN601 (EpCAM targeting ProTriTAC) for potential use in a broad range of solid tumors with high unmet medical need.

Two abstracts have been accepted for poster presentation at the 63rd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition being held virtually and in person in Atlanta, Ga. from December 11-14, 2021. One of these presentations will report interim data from the Phase 1/2 study of HPN217, a half-life extended Tri-Specific T Cell Activating Construct (TriTAC) targeting B cell maturation antigen for the treatment of relapsed/refractory multiple myeloma.

The company’s third proprietary technology platform, extended release TriTAC-XR, is designed to mitigate cytokine release syndrome. Preclinical data supporting TriTAC-XR T cell engager platform will be highlighted in a poster presentation at the 36th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper). The presentation will be available beginning at 7 a.m. on November 12.

Third Quarter 2021 Financial Results

Harpoon ended the third quarter of 2021 with $154.2 million in cash, cash equivalents, and marketable securities compared to $150.0 million as of December 31, 2020. The increase of $4.2 million to the cash balance at the end of the third quarter includes Harpoon’s follow-on financing that closed on January 11, 2021 resulting in net proceeds of approximately $107.6 million, less cash spend during the nine months on operating expenses.

Our cash used in operating activities for the fiscal year ending December 31, 2021 is expected to be $75 million to $80 million, below our original guidance of $85 million to $95 million that was initially provided in March 2021.

Revenue for the third quarter ended September 30, 2021 was $4.5 million compared to $3.9 million for the quarter ended September 30, 2020. For the nine months ended September 30, 2021, revenue was $19.3 million compared to $10.0 million for the nine months ended September 30, 2020. For the third quarter ended September 30, 2021, the increase in revenue was primarily due to an increase in revenue recognized related to Harpoon’s Development and Option Agreement with AbbVie, for research and development services performed. For the nine months ended September 30, 2021, the increase in revenue was primarily due to an increase in revenue recognized due to the delivery of the second target under Harpoon’s Amended and Restated Discovery Collaboration Agreement with AbbVie.

Research and development expense for the third quarter ended September 30, 2021 was $17.0 million compared to $13.1 million for the quarter ended September 30, 2020. For the nine months ended September 30, 2021, R&D expense was $51.5 million compared to $37.5 million for the nine months ended September 30, 2020. The increase for both periods, primarily arose from higher clinical development and personnel-related expense, which included conducting preclinical studies and clinical trials for HPN424, HPN536, HPN217 and HPN328.

General and administrative expense for the third quarter ended September 30, 2021 was $4.2 million compared to $4.4 million for the quarter ended September 30, 2020. For the nine months ended September 30, 2021, G&A expense was $13.1 million compared to $12.3 million for the nine months ended September 30, 2020. For the third quarter ended September 30, 2021, 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, 2021, the increase was due to an increase in personnel expenses related to an increase in headcount and other professional services to support our operations as a public company, partially offset by a decrease in legal expenses associated with Maverick litigation.

Net loss for the third quarter ended September 30, 2021 was $16.7 million compared to $13.3 million for the quarter ended September 30, 2020. The net loss for the nine months ended September 30, 2021 was $95.2 million compared to $38.6 million in the first nine months of the prior year. Net loss for the nine months ended September 30, 2021, includes Maverick litigation settlement of $50.0 million.
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 the majority of the company’s employees continue to telecommute. Harpoon is currently continuing its clinical trials, and has not experienced any material delays or impacts as a result of the COVID-19 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.