Harpoon Therapeutics Reports Fourth Quarter and Full Year 2022 Financial Results and Provides Corporate Update
March 27 2023 - 4:05PM
Harpoon Therapeutics, Inc. (Nasdaq: HARP), a clinical-stage
immuno-oncology company developing novel T cell engagers, today
reported financial results for the fourth quarter and full year
ended December 31, 2022 and provided a corporate update.
“Harpoon is well positioned to reach 2023 key milestones on our
HPN217 and HPN328 clinical studies with a solid balance sheet
extending the cash runway into the second half of 2024,” said Julie
Eastland, President and Chief Executive Officer of Harpoon
Therapeutics. “Our leadership team remains focused on advancing our
clinical pipeline and we anticipate sharing Phase 1 data from our
two clinical programs in the second half of 2023.”
Corporate Update / Recent and Upcoming
Highlights
Tri-specific T cell Activating
Construct (TriTAC®)
Platform
HPN217 (BCMA) Phase 1 trial for
relapsed, refractory multiple myeloma
- Interim results presented at the 64th American Society of
Hematology (ASH) Annual Meeting (cut-off of October 17, 2022), with
additional observations post-ASH include the following:
- Continued evidence of clinical activity with 77% (10/13) ORR
observed in the two highest target dose levels (12 and 24 mg).
- Early durable responses for responding patients with at least 9
months follow up, the median time on treatment is 12 months.
- 86% (18 of 21) responders remain on study treatment with
sustained response, with many responses deepening over time.
- Low incidence of cytokine release syndrome (CRS) across the
patient population studied to date.
- Transient CRS has occurred in 27% of patients across highest
step-dose levels.
- Following ASH 2022, one patient experienced Grade 3 CRS and
Grade 1 ICANS followed by a post-traumatic Grade 5 event (subdural
hematoma).
- Phase 1 dose exploration is expected to complete in the first
half of 2023, with up to 94 patients and identification of a
recommended Phase 2 dose(s) by the end of 2023.
- Data presentation anticipated in the second half of 2023.
- Orphan and Fast Track designation granted for the treatment of
relapsed and refractory multiple myeloma.
HPN328 (DLL3) Phase 1/2 trial in small
cell lung cancer (SCLC) and other neuroendocrine cancers
- As of February 2023, observations in the monotherapy cohorts
included:
- Early signs of anti-tumor activity seen, with two confirmed
partial responses per RECIST in patients with SCLC.
- Priming dose lowered to 1mg and patients requiring oxygen prior
to dosing excluded due to two events of Grade 3 CRS after the
initial priming dose of 2 mg including one Grade 5 respiratory
failure after higher priming dose.
- Phase 1/2 dose and schedule optimization trial ongoing with
monotherapy cohorts enrolling at the 12mg 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 identifying 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 our 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 new candidates for 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 reduce the efficacy of these
potent anti-tumor drugs.
AACR 2023 – Five Preclinical
Posters to be Presented:
- HPN217: Preclinical abstract to be presented at AACR 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”
- HPN328: Two preclinical abstracts to be presented at AACR 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”
- “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”
- ProTriTAC™: Two preclinical abstracts to be presented at AACR
on April 17, 2023:
- “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”
Corporate Update
- Preferred equity financing closed in March 2023, extending cash
runway into the second half of 2024.
- In November 2022, Harpoon announced a corporate restructuring
designed to reduce discovery research and other operating expenses
in 2023 and align its core activities with the organization’s
clinical pipeline.
- In October 2022, Harpoon appointed Luke Walker, M.D., as Chief
Medical Officer. Dr. Walker leads the clinical development strategy
and execution for Harpoon’s multiple clinical programs.
Fourth Quarter and Full Year
2022 Financial Results
- Harpoon ended the fourth quarter of 2022 with $53.1 million in
cash, cash equivalents and marketable securities, compared to
$136.6 million as of December 31, 2021. 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 December 31, 2022 was $4.1
million, compared to $4.3 million for the quarter ended December
30, 2021. For the year ended December 31, 2022, revenue was $31.9
million, compared to $23.7 million for the year ended December 31,
2022. The increase for the year primarily arose from revenue
recognized in 2022 for research and development services performed
on the third and fourth targets 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 December 31, 2022 was $18.9 million, compared to $20.7
million for the quarter ended December 31, 2021. For the year ended
December 31, 2022, R&D expense was $81.4 million, compared to
$72.1 million for the year ended December 31, 2021. The decrease in
the fourth quarter was primarily due to lower costs in research and
lab supplies due to the corporate restructuring and lower costs in
clinical and development costs due to wind down of the HPN424 and
HPN536 programs. The increase for the year primarily arose from
higher clinical and development costs and personnel-related
expense, which included conducting preclinical studies and the
continuation and preparation of the clinical trials for HPN217,
HPN328 and HPN601.
- General and administrative (G&A) expense for the quarter
ended December 31, 2022 was $3.9 million, compared to $5.2 million
for the quarter ended December 31, 2021. For the year ended
December 31, 2022, G&A expense was $18.8 million, compared to
$18.3 million for the year ended December 31, 2021. The decrease in
the fourth quarter was primarily due to lower personnel-related
expense. The increase for the year was primarily attributable to an
increase in legal fees, consulting and other professional services
to support Harpoon’s operations.
- Net loss for the quarter ended December 31, 2022 was $18.4
million, compared to $21.6 million for the quarter ended December
31, 2021. The net loss for the year ended December 31, 2022 was
$67.7 million compared to $116.7 million for the prior year.
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,” “expect,” “look forward,” “plan,”
“potential,” “to be,” “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,
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 and
financing activities; 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, 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’ annual report on Form 10-K for the year
ended December 31, 2022 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:
ICR WestwickeRobert H. UhlManaging Director858-356-5932
robert.uhl@westwicke.com
Media:uncapped
Communications303-588-0599kerry.walton@uncappedcommunications.com
Harpoon Therapeutics,
Inc.Statement of Operations and Comprehensive
Loss (In thousands, except share and per
share amounts)
|
|
Three Months Ended December 31, |
|
Twelve Months Ended December 31, |
|
|
2022 |
|
2021 |
|
2022 |
|
2021 |
Revenue |
|
|
|
|
|
|
|
|
|
|
|
|
Collaboration and license revenue |
|
$ |
4,089 |
|
|
$ |
4,325 |
|
|
$ |
31,915 |
|
|
$ |
23,654 |
|
Total revenue |
|
|
4,089 |
|
|
|
4,325 |
|
|
|
31,915 |
|
|
|
23,654 |
|
Operating expenses |
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
|
18,947 |
|
|
|
20,664 |
|
|
|
81,393 |
|
|
|
72,124 |
|
General and administrative |
|
|
3,854 |
|
|
|
5,202 |
|
|
|
18,847 |
|
|
|
18,327 |
|
Litigation settlement |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
49,954 |
|
Total operating expenses |
|
|
22,801 |
|
|
|
25,866 |
|
|
|
100,240 |
|
|
|
140,405 |
|
Loss from operations |
|
|
(18,712 |
) |
|
|
(21,541 |
) |
|
|
(68,325 |
) |
|
|
(116,751 |
) |
Interest income |
|
|
342 |
|
|
|
36 |
|
|
|
776 |
|
|
|
240 |
|
Other expense |
|
|
(50 |
) |
|
|
(46 |
) |
|
|
(182 |
) |
|
|
(210 |
) |
Net loss |
|
|
(18,420 |
) |
|
|
(21,551 |
) |
|
|
(67,731 |
) |
|
|
(116,721 |
) |
Other comprehensive loss: |
|
|
|
|
|
|
|
|
|
|
|
|
Net unrealized loss on
marketable securities |
|
|
25 |
|
|
|
(47 |
) |
|
|
44 |
|
|
|
(50 |
) |
Comprehensive loss |
|
$ |
(18,395 |
) |
|
$ |
(21,598 |
) |
|
$ |
(67,687 |
) |
|
$ |
(116,771 |
) |
Net loss per share, basic and
diluted |
|
$ |
(0.55 |
) |
|
$ |
(0.66 |
) |
|
$ |
(2.04 |
) |
|
$ |
(3.62 |
) |
Weighted-average shares used
in computing net loss per share, basic and diluted |
|
|
33,683,363 |
|
|
|
32,704,000 |
|
|
|
33,167,435 |
|
|
|
32,274,362 |
|
Harpoon Therapeutics,
Inc.Selected Balance Sheet Data
|
|
As of December 31, |
|
|
|
2022 |
|
|
2021 |
|
|
|
(in thousands) |
|
Cash, cash equivalents, and marketable securities |
|
$ |
53,112 |
|
|
$ |
136,620 |
|
Total assets |
|
$ |
73,729 |
|
|
$ |
155,452 |
|
Total liabilities |
|
$ |
68,330 |
|
|
$ |
97,382 |
|
Total stockholders'
equity |
|
$ |
5,399 |
|
|
$ |
58,070 |
|
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