Harpoon Therapeutics Reports First Quarter 2023 Financial Results and Provides Corporate Update
May 11 2023 - 4:30PM
Harpoon Therapeutics, Inc. (Nasdaq: HARP), a clinical-stage
immuno-oncology company developing novel T cell engagers, today
reported financial results for the first quarter ended March 31,
2023 and provided a corporate update.
“Harpoon is executing its business plan in 2023 with a
strengthened balance sheet, advancing multiple programs based on
the TriTAC® platform, and ProTriTAC™ IND candidates ready for
further development,” said Julie Eastland, President and Chief
Executive Officer of Harpoon Therapeutics. “Following the $25
million preferred equity financing in March 2023, we have the
financial strength to fund current operations into the second half
of 2024. Additionally, we expect to see a positive impact on our
cash burn over the course of the year from the restructuring
implemented in the fourth quarter of last year. We also anticipate
completion of enrollment for two of our Phase 1 clinical programs,
HPN217 and HPN328, and achievement of key data milestones this
year. Our clinical and leadership teams remain focused on advancing
a rich pipeline of next-generation T cell engagers to address a
broad patient population with unmet needs in both solid tumor and
blood cancer indications.”
Corporate Update / Recent and Upcoming
Highlights
Tri-specific T cell Activating
Construct (TriTAC®)
PlatformHPN217 (BCMA) Phase 1 trial for relapsed,
refractory multiple myeloma
- Interim results reported at the 64th American Society of
Hematology (ASH) Annual Meeting (cut-off of October 17, 2022)
demonstrated continued evidence of clinical activity with 77%
(10/13) ORR observed in the two highest target dose levels (12 and
24 mg).
- Overall low incidence of cytokine release syndrome (CRS) across
the patient population studied to date.
- Completion of Phase 1 dose exploration is expected in the first
half of 2023, with identification of a recommended Phase 2 dose(s)
expected by the end of 2023.
- Data presentation anticipated in the second half of 2023.
HPN328 (DLL3) Phase 1/2 trial in small
cell lung cancer (SCLC) and neuroendocrine cancers
- Observations in the monotherapy cohorts, as of February 2023,
included early signs of anti-tumor activity, with two confirmed
partial responses per RECIST in patients with SCLC.
- Phase 1/2 dose and schedule optimization trial ongoing with
monotherapy cohorts enrolling at the 24 mg target dose.
- Enrollment in combination therapy of HPN328 with atezolizumab
(Tecentriq®) in patients with SCLC, as part of the Phase 1/2 dose
escalation trial, is anticipated to begin in the second half of
2023.
- Phase 1 dose exploration is expected to complete in the second
half of 2023, including the identification of a recommended Phase 2
dose(s) in the monotherapy setting by the end of 2023.
- Data presentation anticipated in the second half of 2023.
ProTriTAC™
HPN601 (EpCAM)
- HPN601 is Harpoon’s first conditionally active T cell engager
based on the ProTriTAC™ platform. EpCAM is expressed in a broad
range of solid tumors, potentially enabling HPN601 to address
multiple indications with high unmet medical need.
- IND filing timeline to enable a Phase 1 dose exploration study
dependent on resource allocation.
Two additional candidates
- Two new candidates for potential IND-enabling studies from the
ProTriTAC platform have been identified against the targets
trophoblast cell surface antigen 2 (TROP2) and Integrin-β6
(ITGB6).
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 can reduce
the efficacy of these potent anti-tumor drugs.
AACR 2023 – Five Preclinical
Posters Presented
- HPN217: Poster presented on April 18, 2023:
- “Anti-tumor activity of HPN217, a BCMA-targeting tri-specific T
cell engager, is enhanced by γ-secretase inhibitors in preclinical
models”
- In preclinical mouse models, γ-secretase inhibitors increased
the potency of HPN217 in vitro in multiple cell lines.
- Combination therapy with 1mg/kg LY-3039478 and a subtherapeutic
dose of 4ug/kg HPN217 led to decreased tumor burden and increased
survival in a disseminated MOLP8 xenograft compared to either
monotherapy alone.
- HPN328: Two posters presented on April 18, 2023:
- “Long-term anti-tumor immunity induced by HPN328, a
DLL3-targeting tri-specific, half-life extended T cell engager, in
a preclinical immunocompetent mouse model”
- These results suggest that HPN328 can induce epitope spreading
and prolonged anti-tumor immunity, with an increase in memory T
cells, suggesting a novel mechanism for its activity and efficacy
in vivo.
- These findings suggest that long-term anti-tumor immunity
induced by HPN328 can potentially lead to more durable anti-tumor
responses in cancer patients
- “Anti-tumor activity of HPN328, a DLL3-targeting tri-specific,
half-life extended T cell engager, is enhanced by combining with an
anti-PD-L1 antibody in an immunocompetent mouse model”
- These results demonstrate the utility of combining anti-PD-L1
antibodies to enhance the anti-tumor activity of HPN328 and further
supports investigation of this combination approach in
patients.
- Clinical studies of HPN328 in combination with atezolizumab are
planned.
- ProTriTAC™: Two posters presented on April 17, 2023 introducing
new candidates for IND-enabling studies:
- “TROP2 ProTriTAC™, a protease-activated T cell engager prodrug
targeting TROP2 for the treatment of solid tumors”
- “ITGB6 ProTriTAC™, a protease-activated T cell engager prodrug
targeting Integrin-β6 for the treatment of solid tumors”
- Both data sets support further investigation of Harpoon’s
conditionally active next-generation T cell engager platform,
ProTriTAC™, with demonstrated therapeutic potential in a broad
range of TROP2- and ITGB6-expressing solid tumors.
Corporate Update
- $25 million preferred equity financing closed in March 2023,
extending cash runway into the second half of 2024.
First Quarter 2023 Financial
Results
- Harpoon ended the first quarter of 2023 with $61.4 million in
cash and cash equivalents compared to $53.1 million as of December
31, 2022. Following the $25.0 million preferred equity financing
and year to date ATM sales, cash and cash equivalents are expected
to fund current operations into the second half of 2024.
- Revenue for the quarter ended March 31, 2023 was $8.6 million,
compared to $5.9 million for the first quarter ended March 31,
2022. The increase in revenue was primarily due to revenue
recognized in first quarter 2023 for research and development
services performed on the fourth target under Harpoon’s Restated
Collaboration Agreement with AbbVie, and an increase in revenue
recognized related to Harpoon’s Development and Option Agreement
with AbbVie for research and development services performed.
- Research and development (R&D) expense for the quarter
ended March 31, 2023 was $15.2 million, reduced from $20.8 million
during the first quarter ended March 31, 2022. The decrease
primarily arose from lower personnel-related costs due to corporate
restructuring implemented in November 2022 and lower clinical and
development costs due to the wind down of the HPN424 and HPN536
programs.
- General and administrative (G&A) expense for the quarter
ended March 31, 2023 decreased to $4.2 million, compared to $5.4
million for the first quarter ended March 31, 2022. The decrease
was primarily attributable to lower personnel-related expenses,
lower legal costs, and lower professional service fees to support
Harpoon’s operations.
- Net loss for the first quarter ended March 31, 2023 was $11.3
million, improved from $20.3 million for the first quarter ended
March 31, 2022.
About Harpoon Therapeutics
Harpoon Therapeutics is a clinical-stage immuno-oncology
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 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 “anticipate,” “may,” “expect,” “plan,”
“potential,” “further,” “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 expected progress, results, and plans pertaining to
Harpoon Therapeutics’ clinical trials, including timing, scope,
design and interim results of clinical trials and the safety and
tolerability profile of product candidates, the association of
interim clinical data and preclinical results with potential
treatment outcomes, achievement of future milestones, cash
sufficiency forecasts, including ability to extend cash runway as a
result of the restructuring and financing activities, 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, 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, including
that Harpoon Therapeutics may not achieve the expected benefits of
its restructuring or may incur unexpected additional expenses in
connection with such restructuring. 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 March 31, 2023, 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:
Investors:ICR WestwickeRobert H. Uhl619-228-5886
robert.uhl@westwicke.com
Media:uncapped
Communications303-588-0599kerry.walton@uncappedcommunications.com
Harpoon Therapeutics,
Inc.Statement of Operations and Comprehensive
Loss(Unaudited) (in
thousands, except share and per share amounts)
|
|
For the Three Months Ended
March 31, |
|
|
|
2023 |
|
|
2022 |
|
Revenue |
|
|
|
|
|
|
|
|
Collaboration and license revenue |
|
$ |
8,583 |
|
|
$ |
5,906 |
|
Total revenue |
|
|
8,583 |
|
|
|
5,906 |
|
Operating expenses |
|
|
|
|
|
|
|
|
Research and development |
|
|
15,163 |
|
|
|
20,818 |
|
General and administrative |
|
|
4,185 |
|
|
|
5,401 |
|
Total operating expenses |
|
|
19,348 |
|
|
|
26,219 |
|
Loss
from operations |
|
|
(10,765 |
) |
|
|
(20,313 |
) |
Interest
income, net |
|
|
425 |
|
|
|
40 |
|
Interest
expense |
|
|
(138 |
) |
|
|
— |
|
Other
expense, net |
|
|
(860 |
) |
|
|
(48 |
) |
Net loss
attributable to common stockholders |
|
|
(11,338 |
) |
|
|
(20,321 |
) |
Other
comprehensive loss: |
|
|
|
|
|
|
|
|
Net
unrealized loss on marketable securities |
|
|
3 |
|
|
|
(41 |
) |
Comprehensive loss |
|
$ |
(11,335 |
) |
|
$ |
(20,362 |
) |
Net loss
attributable to common stockholders per share, basic and
diluted |
|
|
(0.31 |
) |
|
|
(0.62 |
) |
Weighted-average shares used in computing net loss per share, basic
and diluted |
|
|
36,968,214 |
|
|
|
32,879,188 |
|
Harpoon Therapeutics,
Inc.Selected Balance Sheet
Data(Unaudited)
|
|
March 31,2023 |
|
|
December 31,2022 |
|
|
|
(in thousands) |
|
Cash and cash equivalents |
|
$ |
61,385 |
|
|
$ |
53,112 |
|
Total
assets |
|
$ |
80,809 |
|
|
$ |
73,729 |
|
Total
liabilities |
|
$ |
80,094 |
|
|
$ |
68,330 |
|
Total
stockholders' equity |
|
$ |
715 |
|
|
$ |
5,399 |
|
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