On November 6, 2019 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 and nine months ended September 30, 2019 and provided a corporate update (Press release, Harpoon Therapeutics, NOV 6, 2019, View Source [SID1234550469]).
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"During the third quarter we made significant strides in the advancement of our novel T cell engagers, as we continue to advance our two clinical stage programs," said Gerald McMahon, Ph.D., President and Chief Executive Officer of Harpoon Therapeutics. "We are also excited by the progress of our two preclinical TriTAC programs, highlighted by the encouraging HPN328 data we recently presented at a medical meeting which further exemplifies the platform. We expect to present clinical data from both our HPN424 and HPN536 programs next year."
Third Quarter 2019 Business Highlights and Other Recent Developments
In October, Harpoon presented data on HPN328 for the treatment of small cell lung cancer at the AACR (Free AACR Whitepaper)-NCI-EORTC AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper) in Boston. The presentation demonstrated that HPN328 has the potential to be an efficacious, safe, and convenient therapeutic for patients with DLL3-expressing malignancies. HPN328 was well-tolerated in cynomolgus monkeys at 1 and 10 mg/kg and pharmacokinetic data support the potential for once weekly dosing.
Patient enrollment and dose escalation continues in Phase 1 trial for HPN424 and Phase 1/2a trial for HPN536. Harpoon plans to present interim HPN424 results at a medical meeting in the first half of 2020 and plans to present proof of concept data for HPN536 in 2020.
Anticipated Milestones
HPN424 – present interim Phase 1 data in the first half of 2020 at a medical conference and initiate expansion cohort in 2020
HPN536 – present proof of concept data in 2020
HPN217 – submit IND by the end of 2019 and initiate Phase 1/2 trial in the first half of 2020
HPN328 – initiate Phase 1 trial in 2020
Third Quarter and Year-to-Date Financial Results
Harpoon Therapeutics ended the third quarter of 2019 with $121.2 million in cash, cash equivalents, and marketable securities compared to $89.5 million as of December 31, 2018. The increase was due to approximately $70.7 million in net proceeds from Harpoon’s initial public offering, completed in February 2019, partially offset by cash used in operations.
Net loss for the third quarter ended September 30, 2019 was $15.9 million compared to $6.8 million for the third quarter ended September 30, 2018. The net loss for the nine months ended September 30, 2019 was $41.3 million compared to $17.6 million in the first nine months of the prior year.
Revenue for the third quarter of 2019 was $1.4 million compared to $1.1 million for the third quarter of 2018. For the nine months ended September 30, 2019, revenue was $3.5 million compared to $3.7 million for the nine months ended September 30, 2018. For the three months ended September 30, 2019, the increase was due to an increase in the recognized portion of the deferred $17.0 million upfront payment received by the company in October 2017 under the collaboration agreement with AbbVie. For the nine months ended September 30, 2019, the decrease was due to an upfront payment of $0.5 million recognized in the first quarter of 2018 related to the license agreement with Werewolf Therapeutics, Inc., offset by a $0.3 million increase in the portion of the upfront payment under the collaboration agreement with AbbVie recognized for the quarter ended September 30, 2019. During both the three and nine month periods, revenue primarily consisted of the recognized portion of the deferred $17.0 million upfront payment under the collaboration agreement with AbbVie.
Research and development (R&D) expense for the third quarter of 2019 was $9.5 million compared to $5.9 million for the third quarter of 2018. For the nine months ended September 30, 2019, R&D expense was $28.9 million, compared to $17.7 million for the nine months ended September 30, 2018. The increase for both periods primarily arose from clinical development expenses and an increase in personnel-related expenses, which included conducting preclinical studies, the continuation of the clinical trials for HPN424 and HPN536, and manufacturing activities for four TriTAC product candidates in various stages of development.
General and administrative (G&A) expense for the third quarter of 2019 was $8.5 million compared to $1.9 million for the third quarter of 2018. G&A expense for the nine months ended September 30, 2019 was $18.1 million compared to $3.9 million for the nine months ended September 30, 2018. The increase for both periods was due to higher expenses primarily related to legal fees associated with ongoing Maverick litigation, consulting and accounting services, an increase in headcount, and other professional services to support our ongoing operations as a public company.