Harpoon Therapeutics Reports Second Quarter 2022 Financial Results and Provides Corporate Update
11 August 2022 - 6:01AM
Harpoon Therapeutics, Inc. (Nasdaq: HARP), a clinical-stage
immunotherapy company developing novel T cell engagers, today
reported financial results for the second quarter ended June 30,
2022 and provided a corporate update.
“We continue to focus our resources and efforts on lead programs
HPN328 and HPN217 from the TriTAC® platform and next generation
ProTriTAC® T cell engager HPN601 to address unmet needs in both
solid and liquid tumors,” said Julie Eastland, President and Chief
Executive Officer of Harpoon Therapeutics. “We are making changes
in resource allocation to ensure Harpoon is well positioned for
future success in the current challenging biotech climate. The
HPN536 program shows promise however, requires continued dose
optimization. Based on our decision to prioritize other assets in
our portfolio, we will seek a partnership for further development
of this program in monotherapy and combination settings. As a
result of our focus and cost saving initiatives, we expect our
current cash balance to extend into the second half of 2023.”
Ms. Eastland continued, “Georgia Erbez, CFO, has decided to
pursue a COO opportunity. We would like to thank Georgia for her
leadership and financial stewardship since joining the company in
2018. Georgia built an organization that can provide the necessary
support until we fill this role. We wish her continued success in
her future endeavors.”
Recent Highlights and Upcoming Milestones
Tri-specific T cell Activating
Construct (TriTAC®)
PlatformHPN328 (DLL3) Phase 1/2 trial in small cell lung
cancer (SCLC) and other neuroendocrine cancers
- In June 2022 Harpoon presented encouraging interim clinical
results in a peer reviewed setting from the ongoing Phase 1 portion
of the trial at the American Society of Clinical Oncology (ASCO)
Annual Meeting 2022. HPN328 demonstrated clinical activity and a
favorable safety profile in patients with small cell lung cancer
(SCLC), neuroendocrine prostate cancer and other neuroendocrine
cancers. To date, study investigators have observed HPN328 is well
tolerated, with 27% of SCLC patients having demonstrated target
lesion reductions of 30% or more, including one confirmed partial
response.
- In April 2022, Harpoon entered into a Master Clinical Supply
Agreement with F. Hoffmann-La Roche Ltd for the supply of
atezolizumab (Tecentriq®). Harpoon is planning to conduct clinical
trials to evaluate HPN328 in combination with atezolizumab for the
treatment of patients with SCLC.
- Dose exploration is continuing with the goal to identify an
initial expansion dose in the Phase 1 safety study by year-end
2022. Additional clinical supply of HPN328 is on track for delivery
early in the fourth quarter of2022, which is expected to allow
further exploration of select doses. Data is anticipated in the
first half of 2023.
HPN217 (BCMA) Phase 1/2 trial for
relapsed, refractory multiple myeloma
- Granted Fast Track designation for the treatment of patients
with relapsed and refractory multiple myeloma.
- Compelling initial clinical activity observed in dose
escalation phase of the ongoing trial. Maximum tolerated dose (MTD)
has not been reached.
- Dose exploration is continuing with ongoing enrollment into
initial expansion cohorts in the Phase 1 safety study.
- Interim data expected by year end 2022.
HPN536 (MSLN) Phase 1/2a trial in
ovarian cancer and other solid tumors
- HPN536 has successfully dose escalated in both fixed and
step-dosing regimens and has been well tolerated at doses up to
7200ng/kg once weekly. Promising pharmacodynamic signals of T cell
engagement have been observed even at sub-therapeutic doses in
patients enrolled in our Phase 1 clinical study, consistent with
published preclinical data.
- Advancement of the program requires further optimization of the
dose and schedule. Based on corporate priorities, Harpoon intends
to seek a partner to further develop HPN536 in monotherapy or
combination studies.
- Patients enrolled in the trial who are benefiting from HPN536
will continue to receive doses and be followed per study
protocol.
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)
- HPN601 is the 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 preparation is advancing, however, due to a contract
manufacturer-driven delay, Harpoon expects to submit the IND in the
first half of 2023.
TriTAC-XR® The
proprietary TriTAC-XR extended-release T cell engager platform is
designed to minimize on-target cytokine release syndrome (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.
- In April 2022, preclinical data supporting Harpoon’s TriTAC-XR
platform were highlighted in a poster presentation at the American
Association for Cancer Research Annual Meeting, demonstrating
improved safety by minimizing CRS.
Nomination of a second clinical
candidate from one of our new platforms is expected by the end of
2022.
Corporate Update
- Georgia Erbez is leaving her current role as Chief Financial
Officer, effective August 31, 2022. Ms. Erbez will serve as a
consultant to the company through the end of the year. A search is
underway for a replacement.
- In July 2022, Harpoon announced the appointments of Wendy Chang
to Senior Vice President, Human Resources and Banmeet Anand, Ph.D.,
to Senior Vice President, Translational Medicine. Both bring deep
experience to their respective roles.
Second Quarter 2022 Financial
Results
- Harpoon ended the second quarter of 2022 with $90.2 million in
cash, cash equivalents and marketable securities compared to $136.6
million as of December 31, 2021. Current cash is expected to fund
operations into the second half of 2023.
- Revenue for the quarter ended June 30, 2022 was $8.3 million,
compared to $5.8 million for the quarter ended June 30, 2021. For
the six months ended June 30, 2022, revenue was $14.2 million
compared to $14.8 million for the six months ended June 30, 2021.
For the second quarter ended June 30, 2022, the increase in revenue
was primarily due to an increase in revenue recognized related to
Harpoon’s Development Option Agreement with AbbVie. For the six
months ended June 30, 2022, the decrease in revenue was primarily
due to a $5.2 million decrease in revenue recognized related to the
Restated Collaboration Agreement due to the delivery of the second
target in first quarter of 2021, under the Restated Collaboration
Agreement, where all remaining deferred revenue associated with
that target was recognized since Harpoon had no further continuing
performance obligations, offset by $4.6 million increase in revenue
recognized related to the Development and Option Agreement, for
research and development services performed.
- Research and development (R&D) expense for the quarter
ended June 30, 2022 was $20.7 million, compared to $18.3 million
for the quarter ended June 30, 2021. For the six months ended June
30, 2022, R&D expense was $41.5 million compared to $34.5
million for the six months ended June 30, 2021. 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 HPN536, HPN217 and HPN328.
- General and administrative (G&A) expense for the quarter
ended June 30, 2022 was $5.1 million, compared to $4.3 million for
the quarter ended June 30, 2021. For the six months ended June 30,
2022, G&A expense was $10.5 million compared to $8.9 million
for the six months ended June 30, 2020. The increase for both
periods was primarily attributable to an increase in
personnel-related expenses due to an increase in headcount and
other professional services to support Harpoon’s operations as a
public company.
- Net loss for the quarter ended June 30, 2022 was $17.4 million,
compared to $16.8 million for the quarter ended June 30, 2021. The
net loss for the six months ended June 30, 2022 was $37.7 million
compared to $78.5 million in the first six months of the prior
year
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 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,” “could,” “expect,” “look
forward,” “plan,” “potential,” “target,” “goal”, “will,” “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 development and advancement of Harpoon Therapeutics’
platforms and product candidates, including cash sufficiency
forecast, progress, plans for partnerships, timing, scope, design
and interim results of clinical trials, the safety and tolerability
profile of product candidates, 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, 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 March 31,
2022 and future filings by Harpoon Therapeutics,
including the Form 10-Q that will be filed for the quarter ended
June 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.
Contacts:
ICR WestwickeRobert H. UhlManaging Director858-356-5932
robert.uhl@westwicke.com
Media:uncapped communications862-368-4464media@harpoontx.com
Harpoon Therapeutics,
Inc.Statement of Operations and Comprehensive
Loss(Unaudited) (in thousands, except
share and per share amounts)
|
|
Three Months Ended June 30, |
|
|
Six Months Ended June 30, |
|
|
|
2022 |
|
|
2021 |
|
|
2022 |
|
|
2021 |
|
Revenue |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Collaboration and license revenue |
|
$ |
8,303 |
|
|
$ |
5,838 |
|
|
$ |
14,209 |
|
|
$ |
14,845 |
|
Total revenue |
|
|
8,303 |
|
|
|
5,838 |
|
|
|
14,209 |
|
|
|
14,845 |
|
Operating expenses |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
|
20,651 |
|
|
|
18,271 |
|
|
|
41,469 |
|
|
|
34,487 |
|
General and administrative |
|
|
5,063 |
|
|
|
4,335 |
|
|
|
10,464 |
|
|
|
8,939 |
|
Litigation settlement |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
49,954 |
|
Total operating expenses |
|
|
25,714 |
|
|
|
22,606 |
|
|
|
51,933 |
|
|
|
93,380 |
|
Loss
from operations |
|
|
(17,411 |
) |
|
|
(16,768 |
) |
|
|
(37,724 |
) |
|
|
(78,535 |
) |
Interest
income |
|
|
104 |
|
|
|
62 |
|
|
|
144 |
|
|
|
156 |
|
Other
expense |
|
|
(44 |
|
|
|
(58 |
) |
|
|
(92 |
) |
|
|
(108 |
) |
Net
loss |
|
|
(17,351 |
) |
|
|
(16,764 |
) |
|
|
(37,672 |
) |
|
|
(78,487 |
) |
Other
comprehensive loss: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net
unrealized gain (loss) on marketable securities |
|
|
32 |
|
|
|
16 |
|
|
|
(9 |
) |
|
|
(4 |
) |
Comprehensive loss |
|
$ |
(17,319 |
) |
|
$ |
(16,748 |
) |
|
$ |
(37,681 |
) |
|
$ |
(78,491 |
) |
Net loss
per share, basic and diluted |
|
$ |
(0.53 |
) |
|
$ |
(0.52 |
) |
|
$ |
(1.14 |
) |
|
$ |
(2.45 |
) |
Weighted-average shares used in computing net loss per share, basic
and diluted |
|
|
33,036,873 |
|
|
|
32,505,777 |
|
|
|
32,958,711 |
|
|
|
32,044,767 |
|
Harpoon Therapeutics,
Inc.Selected Balance Sheet
Data(Unaudited)
|
|
June 30, 2022 |
|
|
December 31, 2021 |
|
|
|
(in thousands) |
|
Cash, cash equivalents, and marketable securities |
|
$ |
90,153 |
|
|
$ |
136,620 |
|
Total
assets |
|
$ |
108,951 |
|
|
$ |
155,452 |
|
Total
liabilities |
|
$ |
82,309 |
|
|
$ |
97,382 |
|
Total
stockholders' equity |
|
$ |
26,642 |
|
|
$ |
58,070 |
|
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