On March 10, 2022 Harpoon Therapeutics, Inc. (Nasdaq: HARP), a clinical-stage immunotherapy company developing novel T cell engagers, reported financial results for the fourth quarter and full year ended December 31, 2021 and provided a corporate update (Press release, Harpoon Therapeutics, MAR 10, 2022, View Source [SID1234609891]).

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"We look forward to additional clinical advancements in the year ahead. We are focusing our resources on portfolio programs that show promising activity, including HPN328 and HPN217, while we advance new candidates into the clinic from our technology platforms," said Julie Eastland, President and Chief Executive Officer of Harpoon Therapeutics. "Additionally, we have conducted a careful and thorough analysis of our HPN424 data, including our clinical results to date, and based on those data we have made the decision to discontinue the HPN424 dose escalation study."

"We are committed to ongoing support of those patients who remain on our HPN424 trial. We thank the patients, investigators and our employees for supporting this clinical study," said Natalie Sacks, M.D., Chief Medical Officer of Harpoon Therapeutics.

Fourth Quarter 2021 and Recent Business Highlights and Upcoming Milestones

In March 2022, Harpoon announced Orphan Drug designation for HPN328 in small cell lung cancer

In March 2022, Harpoon announced Fast Track designation for HPN217 in relapsed, refractory multiple myeloma

In December 2021 Harpoon provided a pipeline update and in January 2022 issued milestone updates to highlight its TriTAC clinical progress, as well as its platform technologies and next clinical candidate in development:

oHPN328 (DLL3)
▪In the ongoing Phase 1/2 trial for HPN328, 3 out of 4 patients with small cell lung cancer in the two highest dose cohorts experienced target lesion (TL) reduction, with one patient achieving a confirmed partial response with a 53% TL reduction.
▪Harpoon to continue dose escalation to determine RP2D by year-end 2022.
oHPN217(BCMA)
▪Compelling initial clinical activity observed in escalation phase of ongoing trial;
▪Harpoon to select an RP2D and initiate dose expansion cohort by mid-2022.
oHPN536 (MSLN)
▪Complete dose escalation by year-end 2022.
oHPN601 (EpCAM)
▪Advancing Harpoon’s first ProTriTAC molecule, with an IND submission anticipated by year-end 2022.

In December 2021, at the 63rd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition, the company reported interim data from the Phase 1/2 study of HPN217, a half-life extended TriTAC targeting B cell maturation antigen (BCMA) for the treatment of relapsed, refractory multiple myeloma. An overall response rate of 63% and a

disease control rate of 88% in the HPN217 2150 µg/week cohort was observed. These interim data demonstrated clinical activity at higher dose levels, strong target engagement, and a manageable safety profile.

In November 2021, preclinical data supporting Harpoon’s proprietary TriTAC-XR T cell engager platform was highlighted in a poster presentation at the 36th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper), demonstrating that the platform could mitigate toxicities such as cytokine release syndrome.

Fourth Quarter and Full Year 2021 Financial Results

Harpoon ended the fourth quarter of 2021 with $136.6 million in cash, cash equivalents, and marketable securities compared to $150.0 million as of December 31, 2020. The decrease of $13.4 million to the cash balance at the end of the fourth 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 twelve months on operating expenses.

The company’s cash used in operating activities for the fiscal year ending December 31, 2021 was $122.1 million, which exclusive of the Maverick litigation resulted in cash OPEX used of $72.1 million compared to our guidance of $75 million to $80 million that was provided in November 2021.

Revenue for the quarter ended December 31, 2021 was $4.3 million compared to $7.5 million for the quarter ended December 31, 2020. Revenue for the year ended December 31, 2021 was $23.7 million, compared to $17.4 million for the year ended December 31, 2020. For the fourth quarter ended December 31, 2021, the decrease in revenue was primarily due to zero revenue recognized related to Harpoon’s Discovery Collaboration agreement with AbbVie. For the twelve months ended December 31, 2021, the increase in revenue was primarily due to revenue recognized from the Development and Option agreement with AbbVie.

Research and development (R&D) expense for the quarter ended December 31, 2021 was $20.7 million compared to $15.1 million for the quarter ended December 31, 2020. R&D expense for the year ended December 31, 2021 was $72.1 million, compared to $52.6 million for the prior year. 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 (G&A) expense for the quarter ended December 31, 2021 was $5.2 million compared to $3.9 million for the quarter ended December 31, 2020. For the year ended December 31, 2021, G&A expense was $18.3 million compared to $16.2 million for the year ended December 31, 2020. For both periods, the increase was primarily attributable 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 quarter ended December 31, 2021 was $21.6 million compared to $11.4 million for the quarter ended December 31, 2020. The net loss for the year ended December 31, 2021 was $116.7 million compared to $49.9 million for the prior year.