Harpoon Therapeutics Reports Third Quarter 2023 Financial Results and Provides Corporate Update
10 November 2023 - 8:01AM
Harpoon Therapeutics, Inc. (NASDAQ: HARP) (the “Company”), a
clinical-stage immunotherapy company developing novel T cell
engagers, today reported financial results for the third quarter
ended September 30, 2023 and provided corporate updates.
“Over the last several months, we have made important progress
and positioned Harpoon for continued momentum ahead. During ESMO
last month, we presented the largest data set so far for HPN328 and
are excited by the clinical benefit observed, particularly the
response data in our 1 mg priming dose cohorts, from which we plan
to select the recommended Phase 2 dose(s) by the of this year. The
HPN328 interim update shows compelling activity with the potential
for best-in-class efficacy as we select the optimized dose to study
across multiple tumor types, including small cell lung cancer,
neuroendocrine prostate cancer, and other neuroendocrine
neoplasms,” said Julie Eastland, President and CEO of Harpoon
Therapeutics. “We look forward to meeting with the regulators in
the first half of 2024 to discuss our development plans.
Additionally, our newly strengthened balance sheet allows us to
continue executing toward multiple value-creating events.”
Corporate Update
- In November, Harpoon regained compliance with all applicable
continued listing standards of the Nasdaq Capital Market.
- In October, Harpoon completed a financing supported by a
top-tier investor syndicate for up to approximately $150 million
including $100 million received at closing and up to $50 million in
cash warrants. The financing extends the cash runway into 2026
assuming $50 million from future exercises of cash warrants issued
with the financing, and into the second half of 2025 with $100
million received at closing, excluding any future proceeds from the
exercise of the cash warrants.
- In August, Harpoon’s Board of Directors approved a reverse
stock split of the Company’s outstanding common stock at a ratio of
one-for-ten. The reverse split became effective September 1,
2023.
Tri-specific T cell Activating Construct
(TriTAC®) Platform
HPN328 (DLL3) Phase 1/2 trial in small cell lung cancer (SCLC),
NEPC, and other neuroendocrine neoplasms
- In October, Harpoon completed enrollment in the Phase 1
monotherapy dose escalation cohorts.
- In October, Harpoon reported favorable interim monotherapy data
in a poster session at the European Society for Medical Oncology
(ESMO) in October in Madrid. The preliminary response data for all
tumor types and patient cohorts treated with 1 mg priming dose was
35%, including three confirmed complete responses. In SCLC, the
confirmed response rate was 32%, with one confirmed complete
response. In patients with other neuroendocrine tumor types, such
as prostate cancer, small cell cervical, small cell bladder, and
large cell lung cancer, the confirmed response rate was 42%,
including two confirmed complete responses. HPN328 was generally
well tolerated across all dose cohorts; cytokine release syndrome
(CRS) was the most common treatment-related adverse event (59%) and
was primarily Grade 1 or 2. No discontinuations were observed for
patients with Grade 1 or 2 CRS.
- In September, the first patients were dosed in the ongoing
Phase 1/2 dose escalation trial evaluating combination therapy of
HPN328 with atezolizumab (Tecentriq®) in patients with SCLC.
- Harpoon expects to identify the recommended Phase 2 dose(s) in
the monotherapy setting by the end of 2023 for discussion with
regulators in the first half of 2024.
- Phase 1 data update of the ongoing Phase 1/2 study is expected
in the first half of 2024.
- Harpoon is planning to conduct one or more Phase 2/3 trials
starting in the second half of 2024, pending dose(s) selection and
discussions with regulators.
HPN217 (BCMA) Phase 1 trial for relapsed, refractory multiple
myeloma (RRMM)
- In November, an abstract detailing the results from the
completed dose escalation portion, up to 24 mg, of the Phase 1
study of HPN217 in patients with RRMM was accepted as an oral
presentation at the upcoming 65th American Society of Hematology
(ASH) Annual Meeting and Exposition being held December 9-12, 2023,
in San Diego.
- In September, HPN217 demonstrated early and durable responses
at the target dose of 12 mg in a Phase 1 trial for RRMM. A 63% ORR
was reported, and a manageable tolerability profile was observed
with low rates of CRS (16%, all G1-2) and no ICANS. Results were
reported in a poster presentation at the 30th International Myeloma
Society (IMS) Annual Meeting in Athens, Greece.
- In September, Harpoon announced the termination of the
Development and Option Agreement, which granted AbbVie an option to
a worldwide, exclusive license to the HPN217 program. The program
remains exclusively owned by Harpoon, and the Company plans to
complete the ongoing Phase 1 trial.
- Recommended Phase 2 regimen(s) expected to be identified by the
end of 2023.
Third Quarter 2023 Financial Results
- Harpoon ended the third quarter of 2023 with $31.6 million in
cash, cash equivalents, short-term marketable securities, compared
to $53.1 million as of December 31, 2022. After the close of the
third quarter, the Company entered into a securities purchase
agreement for a PIPE financing that is expected to result in
upfront gross proceeds of approximately $100 million, with up
to an additional approximately $50 million of gross proceeds upon
cash exercise of warrants, before deducting placement agent fees
and offering expenses.
- Revenue for the third quarter ended September 30, 2023 was $4.5
million, compared to $13.6 million for the third quarter ended
September 30, 2022. For the nine months ended September 30, 2023,
revenue was $33.3 million compared to $27.8 million for the nine
months ended September 30, 2022.
- Research and development (R&D) expense for the third
quarter ended September 30, 2023 was $12.3 million, compared to
$21.0 million for the third quarter ended September 30, 2022. For
the nine months ended September 30, 2023, R&D expense was $39.7
million compared to $62.4 million for the nine months ended
September 30, 2022.
- General and administrative (G&A) expense for the third
quarter ended September 30, 2023 was $4.3 million, compared to $4.5
million for the third quarter ended September 30, 2022. For the
nine months ended September 30, 2023, G&A expense was $12.3
million compared to $15.0 million for the nine months ended
September 30, 2022.
- Impairment of long-lived assets charge for the three and nine
months ended September 30, 2023 was zero and $1.7 million compared
to zero for the three and nine months ended September 30, 2022. The
charge is due to subleasing all office and lab space at the Cove
facility as part of Harpoon’s completed restructuring plan which
required reducing the carrying values of long-lived assets to their
fair values.
- Net loss attributable to common stockholders for the third
quarter ended September 30, 2023 was $1.8 million compared to a net
loss attributable to common stockholders of $11.6 million for the
third quarter ended September 30, 2022. Net loss attributable to
common stockholders for the nine months ended September 30, 2023
was $12.1 million compared to $49.3 million for the nine months
ended September 30, 2022.
About Harpoon TherapeuticsHarpoon
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 Regarding Forward-Looking
StatementsAny statements in this press release about the
Company’s future expectations, plans and prospects, as well as any
other statements regarding matters that are not historical facts,
may constitute “forward-looking statements” within the meaning of
the Private Securities Litigation Reform Act of 1995. Such
statements are subject to risks and uncertainties and actual
results may differ materially from those expressed or implied by
such forward-looking statements. Such statements include, but are
not limited to, statements about the therapeutic potential of our
product candidates, the expected timing, progress, and results of
the Company’s clinical trials and interactions with regulators, the
association of interim clinical data and preclinical results with
potential treatment outcomes, the Company’s data presentation
plans, the Company’s cash sufficiency and runway, including
expected proceeds from warrant exercises , and other statements
containing the words “anticipates,” “believes,” “continue,”
“expects,” “intends,” “look forward,” “plans,” “toward,” “will” and
similar expressions. You should not place undue reliance on
forward-looking statements because they involve known and unknown
risks, uncertainties, and assumptions that are difficult or
impossible to predict and, in some cases, beyond the Company’s
control. These forward-looking statements are based upon the
Company’s current expectations and involve assumptions that may
never materialize or may prove to be incorrect. Actual results and
the timing of events could differ materially from those anticipated
in such forward-looking statements as a result of various risks and
uncertainties, which include, without limitation, risks associated
with market conditions. These and other risks are described in
additional detail in the Company’s filings with the U.S. Securities
and Exchange Commission (SEC). All forward-looking statements
contained in this press release speak only as of the date hereof,
and the Company specifically disclaims any obligation to update any
forward-looking statement, whether because of new information,
future events or otherwise.
Contact:Ana Kaporinvestors@harpoontx.com
Harpoon Therapeutics,
Inc.Statement of Operations and Comprehensive
Loss(Unaudited) (in thousands, except
share and per share amounts)
|
|
For the Three MonthsEnded September 30, |
|
|
For the Nine MonthsEnded September 30, |
|
|
|
2023 |
|
|
2022 |
|
|
2023 |
|
|
2022 |
|
Revenue |
|
|
|
|
|
|
|
|
|
|
|
|
Collaboration and license revenue |
|
$ |
4,448 |
|
|
$ |
13,617 |
|
|
$ |
33,252 |
|
|
$ |
27,826 |
|
Total revenue |
|
|
4,448 |
|
|
|
13,617 |
|
|
|
33,252 |
|
|
|
27,826 |
|
Operating expenses |
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
|
12,325 |
|
|
|
20,977 |
|
|
|
39,684 |
|
|
|
62,446 |
|
General and
administrative |
|
|
4,262 |
|
|
|
4,529 |
|
|
|
12,250 |
|
|
|
14,993 |
|
Impairment of long-lived
assets |
|
|
— |
|
|
|
— |
|
|
|
1,729 |
|
|
|
— |
|
Total operating expenses |
|
|
16,587 |
|
|
|
25,506 |
|
|
|
53,663 |
|
|
|
77,439 |
|
Loss from operations |
|
|
(12,139 |
) |
|
|
(11,889 |
) |
|
|
(20,411 |
) |
|
|
(49,613 |
) |
Interest income, net |
|
|
480 |
|
|
|
289 |
|
|
|
1,520 |
|
|
|
433 |
|
Interest expense |
|
|
(2,046 |
) |
|
|
— |
|
|
|
(3,744 |
) |
|
|
— |
|
Other income (expense),
net |
|
|
11,903 |
|
|
|
(40 |
) |
|
|
10,556 |
|
|
|
(132 |
) |
Net loss attributable to
common stockholders |
|
|
(1,802 |
) |
|
|
(11,640 |
) |
|
|
(12,079 |
) |
|
|
(49,312 |
) |
Other comprehensive loss: |
|
|
|
|
|
|
|
|
|
|
|
|
Net unrealized (loss) gain on
marketable securities |
|
|
(4 |
) |
|
|
28 |
|
|
|
4 |
|
|
|
19 |
|
Comprehensive loss |
|
$ |
(1,806 |
) |
|
$ |
(11,612 |
) |
|
$ |
(12,075 |
) |
|
$ |
(49,293 |
) |
Net loss attributable to
common stockholders per share, basic and diluted |
|
$ |
(0.46 |
) |
|
$ |
(3.52 |
) |
|
$ |
(3.17 |
) |
|
$ |
(14.95 |
) |
Weighted-average shares used
in computing net loss per share, basic and diluted |
|
|
3,947,995 |
|
|
|
3,306,215 |
|
|
|
3,807,955 |
|
|
|
3,299,357 |
|
Harpoon Therapeutics,
Inc.Selected Balance Sheet
Data(Unaudited)
|
|
September 30,2023 |
|
|
December 31,2022 |
|
|
|
(in thousands) |
Cash, cash equivalents and short-term marketable securities |
|
$ |
31,608 |
|
|
$ |
53,112 |
|
Total assets |
|
$ |
47,578 |
|
|
$ |
73,729 |
|
Total liabilities |
|
$ |
43,037 |
|
|
$ |
68,330 |
|
Total stockholders'
equity |
|
$ |
4,541 |
|
|
$ |
5,399 |
|
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