Harpoon Therapeutics Reports Second Quarter 2020 Financial Results and Provides Corporate Update
- Presented positive interim Phase 1 clinical trial data for PSMA-targeting HPN424 in prostate cancer at ASCO20, supporting increased dose escalation
- Dosed first patient with HPN217 targeting BCMA for the treatment of multiple myeloma, triggering a
$50 millionmilestone payment from AbbVie
“Our TriTAC® T cell engager pipeline continues to advance and we were pleased with the encouraging interim Phase 1 data for our lead program, HPN424, that we presented at the ASCO20 Virtual meeting,” said
Second Quarter 2020 Business Highlights and Other Recent Developments
- In April, Harpoon announced the first patient was dosed with HPN217 in a Phase 1/2 clinical trial focused on relapsed/refractory multiple myeloma (RRMM). HPN217 is covered by a global development and option agreement with AbbVie Inc. and dosing of the first patient in the clinical trial triggered a
$50 millionmilestone payment, which was received in June. HPN217 targets B-cell maturation antigen (BCMA), a well-validated target expressed on multiple myeloma cells. HPN217 is Harpoon’s third product candidate to enter the clinic.
- In April, Harpoon appointed
Andrew R. Robbinsand Joseph S. Bailes, M.D., to its Board of Directors as independent board members. Among his many achievements, Mr. Robbinsis credited with leading the highly successful U.S.launch of BRAFTOVI® (encorafenib) + MEKTOVI® (binimetinib) in BRAF-mutant metastatic melanoma. Dr. Bailesis a medical oncologist with substantial experience in clinical practice, legislation, public policy and advocacy. For nearly two decades, he served in various executive leadership capacities with ASCO, including as President.
- In May, Harpoon presented interim data from the ongoing dose-escalation portion of a Phase 1 trial for HPN424 in patients with metastatic castration-resistant prostate cancer (mCRPC) at the
American Society of Clinical Oncology(ASCO) 2020 Virtual Scientific Program. At the time of the data cutoff, 44 patients with progressive mCRPC had been treated in 11 cohorts. Initial safety data showed that HPN424 is generally well tolerated, and cytokine-related adverse events were transient and manageable. Early signals of clinical activity were suggested by multiple patients remaining on study for more than 24 weeks, and several patients with serum PSA declines. Additionally, pharmacokinetic data confirmed half-life extension, which supports the weekly dosing schedule, and pharmacodynamic data supports T cell activation and target engagement, which are consistent with the expected mechanism of action. Patient enrollment continues in the dose escalation phase of the trial in the U.S.and Europe, with a goal to identify a dose for an expansion phase planned for the second half of 2020.
- In May, Harpoon provided a corporate pipeline update. In addition to reiterating and expanding upon HPN424 data presented at ASCO20, Harpoon provided an update on HPN536, its TriTAC currently being studied for the treatment of mesothelin-expressing tumors. Harpoon highlighted that the dose escalation portion of the study was progressing and, as of
May 2020, included 15 ovarian and 10 pancreatic cancer patients. Adverse events were shown to be transient and manageable, and early pharmacokinetic data showed half-life extension supporting once-weekly dosing. In addition, Harpoon also presented advancements in the company’s second platform, ProTriTAC, which builds upon the core elements of the TriTAC platform by utilizing a prodrug approach, designed to allow T cell engagers to address cancer targets that would be limited by on-target toxicities.
- In July, Harpoon appointed
Joanne Viney, Ph.D., to its board of directors as an independent board member. Dr. Vineyis 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.
Second Quarter 2020 Financial Results
- Harpoon ended the second quarter of 2020 with
$175.4 millionin cash, cash equivalents, and marketable securities compared to $155.1 millionas of December 31, 2019. The increase was due to a $50.0 millionmilestone payment received from AbbVie, partially offset by cash used in operations.
- Revenue for the second quarter ended
June 30, 2020was $2.8 millioncompared to $1.1 millionfor the second quarter ended June 30, 2019. For the six months ended June 30, 2020, revenue was $6.1 millioncompared to $2.1 millionfor the six months ended June 30, 2019. During both the three and six month periods, the increase in revenue was primarily due to revenue recognized from the upfront payment under the development and option agreement with AbbVie, signed in November 2019.
- Research and development (R&D) expense for the second quarter ended
June 30, 2020was $11.9 millioncompared to $10.0 millionfor the second quarter ended June 30, 2019. For the six months ended June 30, 2020, R&D expense was $24.4 million, compared to $19.4 millionfor the six months ended June 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) expenses for the quarter ended
June 30, 2020was $3.9 millioncompared to $3.7 millionfor the quarter ended June 30, 2019. G&A expense for the six months ended June 30, 2020was $7.9 millioncompared to $9.6 millionfor the six months ended June 30, 2019. For the quarter ended June 30, 2020, the increase was primarily attributable to an increase in personnel expenses due to an increase in headcount, offset by a decrease in legal fees associated with the Maverick Litigation incurred in 2019. For the six months ended June 30, 2020, the decrease was due to higher expenses incurred in 2019 primarily related to legal fees associated with Maverick litigation and consulting and accounting services, 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 quarter ended
June 30, 2020was $12.7 millioncompared to $11.8 millionfor the quarter ended June 30, 2019. The net loss for the six months ended June 30, 2020was $25.2 millioncompared to $25.4 millionin the first six months of the prior year.
In response to the ongoing COVID-19 pandemic, Harpoon’s executive offices remain closed in compliance with county and state shelter-in-place orders, substantially all of the company’s employees continue to telecommute, with only a limited the number of staff working in the company’s laboratory. Harpoon is currently continuing its clinical trials it has underway at sites in
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 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, the timing of development milestones for product candidates, and the anticipated potential impacts to Harpoon Therapeutics’ business from the ongoing COVID-19 pandemic. 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, unanticipated or greater than anticipated impacts or delays due to COVID-19, 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
||Six Months Ended June 30,|
|Collaboration and license revenue||$||2,762||$||1,063||$||6,059||$||2,126|
|Research and development||11,924||9,971||24,443||19,353|
|General and administrative||3,945||3,734||7,858||9,566|
|Total operating expenses||15,869||13,705||32,301||28,919|
|Loss from operations||(13,107||)||(12,642||)||(26,242||)||(26,793||)|
|Other comprehensive loss:|
|Net unrealized gain (loss) on marketable securities||(229||)||84||201||110|
|Net loss per share, basic and diluted||$||(0.51||)||$||(0.49||)||$||(1.01||)||$||(1.30||)|
|Weighted-average shares used in computing net loss per share, basic and diluted||24,961,183||24,294,211||24,902,229||19,548,600|
Selected Balance Sheet Data
|Cash, cash equivalents, and marketable securities||$||175,448||$||155,129|
|Total stockholders' equity||71,906||94,220|
Source: Harpoon Therapeutics