Harpoon Therapeutics Reports Second Quarter 2019 Financial Results and Provides Corporate Update
- Continued enrollment and dose escalation of Phase 1 trial for HPN424, Harpoon’s lead TriTAC product candidate in development for the treatment of prostate cancer
- Initiated Phase 1/2a clinical trial for HPN536, Harpoon’s second TriTAC product candidate
- IND submission for HPN217 for the treatment of multiple myeloma expected by year end followed by Phase 1 clinical trial initiation in the first quarter of 2020
“I am pleased with the exciting progress Harpoon has made so far in 2019 with two T cell engagers, HPN424 and HPN536, in the clinic as planned,” said
“Consistent with the TriTAC mechanism of action, we observed T cell activation and cytokine induction with HPN424 treatment, which prompted us to explore the use of dexamethasone as a premedication to limit potential adverse events,” said
Second Quarter 2019 Business Highlights and Other Recent Developments
- HPN424, Harpoon’s lead product candidate in development as a potential treatment for prostate cancer, continues to enroll patients in a Phase 1 clinical trial. The treatment regimen has been modified to include premedication with dexamethasone, tapered over several weeks. Several patients have completed the scheduled taper, and have successfully continued treatment with HPN424 in the absence of dexamethasone. Enrollment is ongoing, with patients now being treated in the seventh dose-escalation cohort. Pharmacokinetics observed to date continue to support once-weekly dosing of HPN424. Harpoon plans to present interim results at a medical meeting in the first half of 2020.
- In April, Harpoon advanced its second TriTAC, HPN536, a mesothelin-targeting T cell engager, into the clinic and dosed the first patient in a Phase 1/2a clinical trial for ovarian and other mesothelin-expressing solid tumors. Patient enrollment continues as planned and two dosing cohorts have been completed. The study consists of two phases, an initial dose escalation phase of approximately 20 ovarian cancer patients, followed by an expansion phase of up to three additional parallel cohorts of 20 patients each with ovarian, pancreatic and mesothelioma cancer. The study is collecting data to evaluate the safety, tolerability, pharmacokinetics and activity of HPN536. For additional information about the trial, please visit clinicaltrials.gov using the identifier NCT03872206.
- 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 trial in the first quarter of 2020
- HPN328 – initiate Phase 1 trial in 2020
Second Quarter Financial Results
Harpoon Therapeuticsended the second quarter of 2019 with $133.9 millionin cash, cash equivalents, and marketable securities compared to $89.5 millionas of December 31, 2018. The increase was due to approximately $71 millionin net proceeds from Harpoon’s initial public offering, completed in February 2019, partially offset by cash used in operations.
- Net loss for the second quarter ended
June 30, 2019was $11.8 millioncompared to $6.0 millionfor the second quarter ended June 30, 2018. The net loss for the six months ended June 30, 2019was $25.4 millioncompared to $10.9 millionin the first six months of the prior year.
- Revenue for the second quarter of 2019 was
$1.1 millioncompared to $1.1 millionfor the second quarter of 2018. For the six months ended June 30, 2019, revenue was $2.1 millioncompared to $2.6 millionfor the six months ended June 30, 2018. For the six months ended June 30, 2019, the decrease was due to an upfront payment of $0.5 millionrecognized in the first quarter of 2018 related to our license agreement with Werewolf Therapeutics, Inc.During both the three and six month periods, revenue primarily consisted of the amortized portion of the deferred $17.0 millionupfront payment received in October 2017under the collaboration agreement with AbbVie.
- Research and development (R&D) expense for the second quarter of 2019 was
$10.0 millioncompared to $6.2 millionfor the second quarter of 2018. For the six months ended June 30, 2019, R&D expense was $19.4 million, compared to $11.7 millionfor the six months ended June 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 second quarter of 2019 was
$3.7 millioncompared to $1.0 millionfor the second quarter of 2018. G&A expense for the six months ended June 30, 2019was $9.6 millioncompared to $1.9 millionfor the six months ended June 30, 2018. The increase for both periods was due to an increase in consulting and accounting services primarily related to the 2018 audit, legal fees, headcount, and other professional services to support our ongoing operations as a public company.
Cautionary Note on Forward-looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as “may,” “will,” “expect,” “plan,” “anticipate,” “target,” “estimate,” “intend” and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. These forward-looking statements are based on Harpoon Therapeutics’ expectations and assumptions as of the date of this press release. Each of these forward-looking statements involves risks and uncertainties that could cause Harpoon Therapeutics’ clinical development programs, future results or performance to differ significantly from those expressed or implied by the forward-looking statements. Forward-looking statements contained in this press release include, but are not limited to, statements about the timing of IND submissions, the progress, timing, scope and anticipated results of clinical trials, the timing of the presentation of data, the association of data with potential treatment outcomes, the development and advancement of product candidates, and the timing of development milestones for product candidates. Many factors may cause differences between current expectations and actual results, including unexpected safety or efficacy data observed during clinical studies, clinical trial site activation or enrollment rates that are lower than expected, changes in expected or existing competition, changes in the regulatory environment, the uncertainties and timing of the regulatory approval process, and unexpected litigation or other disputes. Other factors that may cause Harpoon Therapeutics’ actual results to differ from those expressed or implied in the forward-looking statements in this press release are discussed in Harpoon Therapeutics’ filings with the
Chief Financial Officer
Statement of Operations and Comprehensive Loss
(in thousands, except share and per share amounts)
|Three Months Ended June 30,||Six Months Ended June 30,|
|Collaboration and license revenue||$||1,063||$||1,063||$||2,126||$||2,626|
|Research and development||9,971||6,151||19,353||11,684|
|General and administrative||3,734||967||9,566||1,949|
|Total operating expenses||13,705||7,118||28,919||13,633|
|Loss from operations||(12,642||)||(6,055||)||(26,793||)||(11,007||)|
|Other comprehensive loss:|
|Net unrealized gain on marketable securities||84||—||110||—|
|Net loss per share, basic and diluted||$||(0.49||)||$||(5.89||)||$||(1.30||)||$||(10.95||)|
|Weighted-average shares used in computing net loss per share, basic and diluted||24,294,211||1,017,336||19,548,600||993,418|
Selected Balance Sheet Data
|June 30, 2019||December 31, 2018|
|Cash, cash equivalents, and marketable securities||$||133,884||$||89,493|
|Total convertible preferred stock||—||129,577|
|Total stockholders' equity (deficit)||122,473||(53,479||)|
Source: Harpoon Therapeutics