UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
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Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b–2 of the Securities Exchange Act of 1934 (§ 240.12b–2 of this chapter).
Emerging growth company
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If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.
Item 2.02 Results of Operations and Financial Condition.
On August 5, 2021, Harpoon Therapeutics, Inc. (“Harpoon”) issued a press release announcing its financial results for the three and six month periods ended June 30, 2021. A copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.
The information in this Item 2.02 of this Form 8-K and the Exhibit 99.1 attached hereto shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that Section, or incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such a filing.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits.
Exhibit No. |
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Description |
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99.1 |
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104 |
Cover Page Interactive Data File (embedded within the Inline XBRL document) |
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
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HARPOON THERAPEUTICS, INC. |
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By: |
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/s/ Gerald McMahon, Ph.D. |
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Gerald McMahon, Ph.D. President and Chief Executive Officer |
Dated: August 5, 2021
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EXHIBIT 99.1
FOR IMMEDIATE RELEASE
Harpoon Therapeutics Reports Second Quarter 2021 Financial Results and Provides Corporate Update
Presented updated interim Phase 1/2a clinical trial data for PSMA-targeting TriTAC® HPN424 in prostate cancer at ASCO Annual Meeting
Provided clinical trial updates for three additional TriTAC programs and ProTriTAC platform
SOUTH SAN FRANCISCO, Calif., August 5, 2021 - Harpoon Therapeutics, Inc. (Nasdaq: HARP), a clinical-stage immunotherapy company developing a novel class of T cell engagers, today reported financial results for the second quarter ended June 30, 2021 and provided a corporate update.
“The clinical data emerging for our proprietary TriTAC portfolio continues to be encouraging as HPN424, HPN536 and HPN328 have shown cancer target engagement, significant treatment duration, and either tumor size reductions or stable disease,” said Jerry McMahon, Ph.D., President and Chief Executive Officer of Harpoon Therapeutics. “Looking ahead into to the second half of 2021, we remain focused on increasing dose levels across all four programs and providing additional interim clinical pipeline data by year end.”
Second Quarter 2021 Business Highlights and Other Recent Developments
Dose escalation is ongoing, and we have recently opened a 450 ng/kg step dose cohort. The first patient has successfully reached the target dose of 450 ng/kg.
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Second Quarter 2021 Financial Results
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Anticipated 2021 Milestones
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 yet 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.
About Harpoon Therapeutics
Harpoon Therapeutics is a clinical-stage immunotherapy company developing a novel class of T cell engagers that harness the power of the body’s immune system to treat patients suffering from cancer and other diseases. T cell engagers are engineered proteins that direct a patient’s own T cells to kill target cells that express specific proteins, or antigens, carried by the target cells. Using its proprietary Tri-specific T cell Activating Construct (TriTAC®) platform, Harpoon is developing a pipeline of novel TriTACs initially focused on the treatment of solid tumors and hematologic malignancies. HPN424 targets PSMA and is in a Phase 1/2a trial for metastatic castration-resistant prostate cancer. HPN536 targets mesothelin and is in a Phase 1/2a trial for cancers expressing mesothelin, initially focused on ovarian and pancreatic cancers. HPN217 targets BCMA and is in a Phase 1/2 trial for relapsed, refractory multiple myeloma. HPN328 targets DLL3 and is in a Phase 1/2 trial for small cell lung cancer and other DLL3-associated tumors. Harpoon has also developed a proprietary ProTriTAC™ platform, which applies a prodrug concept to its TriTAC platform to create a therapeutic T cell engager that remains inactive until it reaches the tumor. For additional information about Harpoon Therapeutics, please visit www.harpoontx.com.
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,” “potential,” “anticipate,”
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“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 preclinical and clinical trials, the timing of the presentation of data, the association of data with potential treatment outcomes, the development and advancement of product candidates, anticipated 2021 development milestones for its product candidates and the timing thereof, the anticipated potential impacts to Harpoon Therapeutics’ business from the ongoing COVID-19 pandemic, and other statements that are not historical fact. 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, the timing and results of unexpected litigation or other disputes, and the sufficiency of Harpoon Therapeutics’ cash resources. These and 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 U.S. Securities and Exchange Commission, including under “Risk Factors” in Harpoon Therapeutics’ annual report on Form 10-K for the year ended December 31, 2020 and future filings by Harpoon Therapeutics. Except as required by law, Harpoon Therapeutics assumes no obligation to update any forward-looking statements contained herein to reflect any change in expectations, even as new information becomes available.
Contacts:
Harpoon Therapeutics, Inc.
Georgia Erbez
Chief Financial Officer
media@harpoontx.com
Westwicke ICR
Robert H. Uhl
Managing Director
858-356-5932
robert.uhl@westwicke.com
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Harpoon Therapeutics, Inc.
Statement of Operations and Comprehensive Loss
(Unaudited)
(in thousands, except share and per share amounts)
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Three Months Ended June 30, |
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Six Months Ended June 30, |
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2021 |
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2020 |
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2021 |
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2020 |
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Revenue |
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Collaboration and license revenue |
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$ |
5,838 |
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$ |
2,762 |
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$ |
14,845 |
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$ |
6,059 |
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Total revenue |
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5,838 |
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2,762 |
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14,845 |
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6,059 |
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Operating expenses |
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Research and development |
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18,271 |
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11,924 |
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34,487 |
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24,443 |
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General and administrative |
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4,335 |
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3,945 |
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8,939 |
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7,858 |
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Litigation settlement |
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— |
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— |
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49,954 |
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— |
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Total operating expenses |
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22,606 |
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15,869 |
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93,380 |
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32,301 |
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Loss from operations |
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(16,768 |
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(13,107 |
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(78,535 |
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(26,242 |
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Interest income |
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62 |
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415 |
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156 |
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999 |
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Other expense |
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(58) |
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— |
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(108 |
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(1 |
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Net loss |
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(16,764 |
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(12,692 |
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(78,487 |
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(25,244 |
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Other comprehensive loss: |
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Net unrealized gain (loss) on marketable securities |
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16 |
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(229) |
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(4) |
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201 |
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Comprehensive loss |
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$ |
(16,748 |
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$ |
(12,921 |
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$ |
(78,491 |
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$ |
(25,043 |
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Net loss per share, basic and diluted |
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$ |
(0.52 |
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$ |
(0.51 |
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$ |
(2.45 |
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$ |
(1.01 |
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Weighted-average shares used in computing net loss per share, basic and diluted |
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32,505,777 |
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24,961,183 |
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32,044,767 |
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24,902,229 |
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Harpoon Therapeutics, Inc.
Selected Balance Sheet Data
(Unaudited)
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June 30, 2021 |
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December 31, 2020 |
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(in thousands) |
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Cash, cash equivalents, and marketable securities |
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$ |
175,212 |
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$ |
149,976 |
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Total assets |
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$ |
196,177 |
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$ |
171,592 |
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Total liabilities |
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$ |
105,249 |
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$ |
117,753 |
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Total stockholders' equity |
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$ |
90,928 |
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$ |
53,839 |
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