UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
CURRENT REPORT
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Item 2.02 Results of Operations and Financial Condition.
On November 14, 2022, Harpoon Therapeutics, Inc. (the “Company”) issued a press release announcing its financial results for the three and nine month periods ended September 30, 2022. 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/ Julie Eastland |
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Julie Eastland President and Chief Executive Officer |
Dated: November 14, 2022
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EX99.1
Harpoon Therapeutics Updates Strategic Priorities and Reports Third Quarter 2022 Financial Results
HPN217 (BCMA) interim data update at ASH 2022; HPN328 (DLL3) exploring dosing regimens and HPN601 (EpCAM) expected to enter the clinic in 2023
Strategic realignment to focus resources on ongoing clinical programs; restructuring workforce to support prioritized clinical development, reduce operating expense, and extend cash runway
Following restructuring, current cash and equivalents of $66.1 million expected to fund operations through the end of 2023
SOUTH SAN FRANCISCO, Calif., November 14, 2022 - Harpoon Therapeutics, Inc. (Nasdaq: HARP), a clinical-stage immunotherapy company developing novel T cell engagers, today provided an update on strategic priorities and reported financial results for the third quarter ended September 30, 2022.
“Harpoon continues to advance its next-generation T cell engagers to address a broad patient population with unmet needs in both solid tumor and blood cancer indications,” said Julie Eastland, President and Chief Executive Officer of Harpoon Therapeutics. “We have made the decision to fully focus our resources on our collaborations and the clinical development of HPN217 targeting BCMA, HPN328 targeting DLL3 and HPN601 targeting EpCAM, all of which are in or nearing the clinic. As a result, we will be reducing our workforce by approximately 45%, primarily research and supportive functions.”
Ms. Eastland continued, “We have implemented a corporate restructuring designed to reduce operating expenses and align core activities with the organization’s focused clinical programs that are expected to drive long-term growth. We are grateful for the dedication and contributions of our valued colleagues whose efforts have innovated and advanced this novel T cell engager technology into the clinic. These restructuring and cost reduction efforts are expected to fund and support our operations, further extending our cash position through the end of 2023.”
Business Update / Recent and Upcoming Highlights
Tri-specific T cell Activating Construct (TriTAC®) Platform
HPN217 (BCMA) Phase 1/2 trial for relapsed, refractory multiple myeloma
“We are really encouraged by what we are seeing with HPN217 in heavily pretreated relapsed/refractory multiple myeloma,” said Luke Walker, M.D., Chief Medical Officer of Harpoon Therapeutics. “We look forward to presenting updated clinical results, including additional safety, efficacy and pharmacodynamic data from patients enrolled at higher dose levels at ASH 2022.”
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HPN328 (DLL3) Phase 1/2 trial in small cell lung cancer (SCLC) and other neuroendocrine cancers
The HPN328 Phase 1 study continues to explore dose regimens to optimize tolerability and benefit in patients with neuroendocrine tumors. Recently, Harpoon lowered the priming dose from 2mg to 1mg for future cohorts and amended the protocol to exclude patients from being treated with HPN328 who require oxygen prior to dosing, to help reduce the risk of respiratory complications. These changes follow two events of Grade 3 cytokine release syndrome (CRS) following an initial 2mg priming dose of HPN328 during the dose escalation portion of the study. CRS in one patient resolved with treatment. CRS in a second patient was complicated by a requirement for oxygen prior to dosing and other complications that led to an additional event of Respiratory Failure, which led to the patient’s death. The events have been reported to regulatory authorities as required.
HPN536 (MSLN) Phase 1/2a trial in ovarian cancer and other solid tumors
ProTriTAC™
ProTriTAC is a conditionally active T cell engager platform designed to be preferentially active in the tumor. This enables Harpoon’s T cell engagers to address more broadly expressed solid tumor targets across multiple tumor types.
HPN601 (EpCAM)
TriTAC-XR®
The proprietary TriTAC-XR extended-release T cell engager platform is designed to minimize on-target CRS, a characteristic of many T cell engagers that can lead to dose limiting toxicities and reduce the efficacy of these potent anti-tumor drugs.
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Corporate Update
Third Quarter 2022 Financial Results
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. Harpoon has also
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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. Harpoon’s third proprietary technology platform, extended release TriTAC-XR, is designed to mitigate cytokine release syndrome. 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 “expect,” “look forward,” “plan,” “potential,” “will,” 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 development and advancement of, and milestones concerning, Harpoon Therapeutics’ platforms and product candidates, including timing, scope, design and interim results of clinical trials, the safety and tolerability profile of product candidates, including ability to resume enrollment in the HPN328 clinical trial and reduce the risk of respiratory complications; expectations concerning the ability to make regulatory submissions and the timing thereof; cash sufficiency forecast, including ability to extend cash runway as a result of the restructuring; progress and plans for partnerships, 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, preliminary data and trends may not be predictive of future data or results, may not demonstrate safety or efficacy or lead to regulatory approval by the FDA or other regulatory agencies, 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, the ability to realize the expected benefits from the restructuring, 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’ quarterly report on Form 10-Q for the quarter ended June 30, 2022 and future filings by Harpoon Therapeutics, including the Form 10-Q that will be filed for the quarter ended September 30, 2022. 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.
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Contacts:
ICR Westwicke
Robert H. Uhl
Managing Director
858-356-5932
robert.uhl@westwicke.com
Media:
uncapped Communications
512-825-2603
megan.russell@uncappedcommunications.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 September 30, |
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Nine Months Ended September 30, |
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2022 |
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2021 |
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2022 |
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2021 |
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Revenue |
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Collaboration and license revenue |
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$ |
13,617 |
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$ |
4,484 |
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$ |
27,826 |
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$ |
19,329 |
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Total revenue |
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13,617 |
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4,484 |
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27,826 |
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19,329 |
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Operating expenses |
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Research and development |
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20,977 |
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16,973 |
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62,446 |
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51,460 |
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General and administrative |
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4,529 |
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4,186 |
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14,993 |
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13,125 |
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Litigation settlement |
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— |
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— |
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— |
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49,954 |
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Total operating expenses |
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25,506 |
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21,159 |
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77,439 |
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114,539 |
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Loss from operations |
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(11,889 |
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(16,675 |
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(49,613 |
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(95,210 |
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Interest income |
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289 |
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48 |
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433 |
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204 |
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Other expense |
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(40) |
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(55) |
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(132 |
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(163 |
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Net loss |
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(11,640 |
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(16,682 |
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(49,312 |
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(95,169 |
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Other comprehensive loss: |
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Net unrealized gain (loss) on marketable securities |
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28 |
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1 |
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19 |
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(3) |
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Comprehensive loss |
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$ |
(11,612 |
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$ |
(16,681 |
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$ |
(49,293 |
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$ |
(95,172 |
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Net loss per share, basic and diluted |
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$ |
(0.35 |
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$ |
(0.51 |
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$ |
(1.49 |
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$ |
(2.96 |
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Weighted-average shares used in computing net loss per share, basic and diluted |
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33,062,148 |
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32,637,660 |
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32,993,568 |
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32,176,132 |
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Harpoon Therapeutics, Inc.
Selected Balance Sheet Data
(Unaudited)
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September 30, 2022 |
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December 31, 2021 |
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(in thousands) |
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Cash, cash equivalents, and marketable securities |
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$ |
66,098 |
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$ |
136,620 |
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Total assets |
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$ |
83,496 |
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$ |
155,452 |
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Total liabilities |
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$ |
66,584 |
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$ |
97,382 |
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Total stockholders' equity |
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$ |
16,912 |
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$ |
58,070 |
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