Harpoon Therapeutics Reports Fourth Quarter and Full Year 2018 Financial Results and Provides Corporate Update
- Lead Tri-specific T cell Activating Construct (TriTAC) candidate, HPN424, continues to advance in a Phase 1 clinical trial for the treatment of prostate cancer
Initial public offering, successfully completed in February, raised
$70.7 millionin net cash proceeds
- Advanced HPN328, a DLL3 (Delta-like 3) -targeting TriTAC, for the treatment of small cell lung cancer, into IND-enabling studies
Webcast and conference call today at
1:30 p.m. PT
“The past year included achievement of significant clinical, scientific
and operational milestones for Harpoon Therapeutics,” said Gerald
McMahon Ph.D., President and Chief Executive Officer of
“Our scientific expertise has led to the discovery and development of
three TriTACs on paths for clinical development. We are pleased to
announce today that we have selected an additional drug candidate,
targeting DLL3, for potential clinical development in small cell lung
2018 Business Highlights
- Advanced our lead TriTAC product candidate, HPN424 into a Phase 1 clinical trial in prostate cancer. Utilizing its proprietary TriTAC platform, Harpoon has developed HPN424, a half-life extending T cell engager specifically designed to target prostate specific membrane antigen, or PSMA, for the treatment of prostate cancer. PSMA is present in 80-95% of patients with advanced prostate cancer. In July, Harpoon filed an IND for HPN424 and in August, commenced a Phase 1 trial. The Phase 1 trial is designed to enroll patients with progressive metastatic castration-resistant prostate cancer (mCRPC) in two parts, dose escalation and dose expansion. The company is currently enrolling patients in the dose escalation part of the trial.
Advanced two additional TriTAC product candidates, creating a robust
development pipeline. The company’s proprietary TriTAC platform was
designed to advance the therapeutic potential of T cell engagers, with
a proprietary half-life extended format. Harpoon achieved multiple
development milestones with its TriTAC pipeline in 2018 and intends to
have four TriTACs in on-going clinical trials by the end of 2020.
HPN536 is a mesothelin-targeting TriTAC, designed as a potential
therapy for ovarian cancer and other solid tumors. Mesothelin, a
clinically validated target, is expressed on malignant cells of
ovarian cancer, mesothelioma, pancreatic carcinoma, non-small cell
lung cancer and triple-negative breast cancer, among others.
Harpoon submitted the IND for HPN536 in December and received
FDAclearance in January 2019. Harpoon anticipates a Phase 1/2a trial will commence in the first half 2019.
HPN217 is a TriTAC that targets BCMA and is in preclinical
development for the potential treatment of multiple myeloma. At
American Society of HematologyAnnual Meeting, the company released new preclinical data for HPN217 which demonstrated BCMA- and T cell-dependent antitumor activity in tissue culture and in xenografts modeling multiple myeloma and lymphoma. Harpoon expects to file an IND for HPN217 later this year.
- HPN536 is a mesothelin-targeting TriTAC, designed as a potential therapy for ovarian cancer and other solid tumors. Mesothelin, a clinically validated target, is expressed on malignant cells of ovarian cancer, mesothelioma, pancreatic carcinoma, non-small cell lung cancer and triple-negative breast cancer, among others. Harpoon submitted the IND for HPN536 in December and received
Harpoon raised approximately
$89.7 millionin two financings in 2018. In November, the company closed a Series C equity financing, receiving $69.7 millionin net proceeds. In July, in connection with the successful filing of the IND for HPN424, Harpoon received $20.0 millionin net proceeds for closing the second tranche of its Series B equity financing.
Harpoon broadened its leadership team, adding expertise to support
clinical development and public company readiness. Additions in 2018
included the appointments of
Georgia Erbezas Chief Financial Officer and Natalie Sacks, M.D., as Chief Medical Officer. Holger Wesche, Ph.D., was promoted to Chief Scientific Officer. The leadership team at Harpoon has proven expertise in drug development, spanning early-stage development of oncology therapies through commercialization.
Expanded the board with the appointment of three independent
Jonathan Drachman, M.D., former Chief Medical Officer, Seattle Genetics; Scott Myers, Chairman and Chief Executive Officer, Rainier Therapeutics; and Julie Eastland, Chief Business and Financial Officer, Rainier Therapeutics. These board members, along with the existing directors, provide a wealth of experience in drug development, financial strategy and business development.
January 2019, Harpoon announced preliminary data for HPN424 that suggested HPN424 activated T cells in a manner that is consistent with target engagement. In addition, early evidence suggested that there was sufficient drug exposure during the treatment course to support once-weekly dosing. Side effects were consistent with T cell activation and were managed clinically.
February 2019, Harpoon successfully completed its initial public offering, raising net proceeds of approximately $70.7 million.
- Harpoon today announced the designation of its fourth TriTAC in development, HPN328, for the potential treatment of small cell lung cancer (SCLC). HPN328 targets DLL3, a protein highly expressed in a majority of SCLC tumors but not in normal tissue. This selective expression makes DLL3 an attractive drug target for T cell engagers. Harpoon is currently conducting IND-enabling studies and expects to initiate a Phase 1 clinical trial of HPN328 in 2020.
Harpoon plans to have three TriTAC product candidates in the clinic by the end of 2019, with a fourth expected in 2020, as follows:
- HPN424 – present additional Phase 1 data in the second half of 2019 at a medical conference
- HPN536 – initiate Phase 1/2a trial in the first half of 2019
- HPN217 – initiate Phase 1 trial in the second half of 2019
- HPN328 – initiate Phase 1 trial in 2020
Fourth Quarter and Full Year 2018 Financial Results
Harpoon Therapeuticsended 2018 with $89.5 millionin cash and cash equivalents compared to $29.4 millionas of December 31, 2017. Net cash provided by financing activities for the year ended December 31, 2018was $88.3 million, primarily comprised of $69.7 millionin net cash proceeds received from the November 2018issuance of Series C convertible preferred stock and $20.0 millionin net cash proceeds received from the July 2018issuance of Series B convertible preferred stock as a result of the IND filing for HPN424. Net cash used in operations for the year ended December 31, 2018was $27.1 million.
Net loss for the fourth quarter ended
December 31, 2018was $9.7 millioncompared to $4.9 millionfor the fourth quarter ended December 31, 2017. Net loss for the year ended December 31, 2018was $27.4 million, compared to $16.8 millionfor the prior year.
Revenue for the fourth quarter ended
December 31, 2018was $1.1 millioncompared to $0.7 millionfor the fourth quarter ended December 31, 2017. Revenue for the year ended December 31, 2018was $4.8 million, compared to $0.7 millionfor the prior year. During both periods, the revenue primarily consisted of the amortized portion of the deferred $17.0 millionupfront payment received in October 2017under a collaboration agreement with AbbVie.
Research and development expense for the fourth quarter ended
December 31, 2018was $8.7 millioncompared to $4.8 millionfor the fourth quarter ended December 31, 2017. R&D expense for the year ended December 31, 2018was $26.4 million, compared to $13.6 millionfor the prior year. The increases in both comparative periods were primarily due to clinical development expenses and an increase in personnel-related expenses, including conducting preclinical studies, initiating the first clinical trial for lead product candidate, HPN424, and manufacturing activities for four TriTAC product candidates in various stages of development.
General and administrative expense for the quarter ended
December 31, 2018was $2.2 millioncompared to $0.9 millionfor the quarter ended December 31, 2017. General and administrative expenses for the year ended December 31, 2018were $6.1 million, compared to $3.6 millionfor the prior year. The increases over both comparative periods were primarily due to an increase in consulting and accounting services related to quarterly reviews and year-end audits and an increase in headcount.
Conference Call Information
Harpoon will host a conference call and live audio webcast this
The live call may be accessed by dialing 866-951-6894 for domestic
callers and 409-261-0624 for international callers and using conference
ID: 2497976. A live webcast of the call will be available online from
the investor relations section of the
An archived replay of the webcast will be available on Harpoon Therapeutics’ website shortly after the conference call.
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 “may,” “will,” “expect,” “plan,” “anticipate,” “target,”
“estimate,” “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 progress, timing, scope and results of clinical
trials, the association of data with treatment outcomes and the timing
and likelihood of development milestones for product candidates. Many
factors may cause differences between current expectations and actual
results, including unexpected safety or efficacy data observed during
preclinical or clinical studies, 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, and
unexpected litigation or other disputes. 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
|Harpoon Therapeutics, Inc.|
|Statements of Operations|
(in thousands, except share and per share amounts)
Three Months Ended December 31,
Twelve Months Ended December 31,
|Collaboration and license revenue||$||1,063||$||708||$||4,750||$||708|
|Research and development||8,717||4,791||26,368||13,622|
|General and administrative||2,215||912||6,106||3,614|
|Total operating expenses||10,932||5,703||32,474||17,236|
|Loss from operations||(9,869||)||(4,995||)||(27,724||)||(16,528||)|
|Net loss per share, basic and diluted||(8.15||)||(5.27||)||(25.65||)||(18.81||)|
|Weighted-average shares used in computing net loss per share, basic and diluted||1,193,797||938,372||1,066,877||894,901|
|Harpoon Therapeutics, Inc.|
|Selected Balance Sheet Data|
|As of December 31,|
|Cash and cash equivalents||$||89,493||$||29,423|
|Total convertible preferred stock||129,577||39,841|
|Total stockholders' deficit||(53,479||)||(26,943||)|
Harpoon Therapeutics, Inc.
Chief Financial Officer
Westwicke Partners, LLC.
Robert H. Uhl