On August 10, 2022 Deciphera Pharmaceuticals, Inc. (NASDAQ: DCPH), a biopharmaceutical company focused on discovering, developing, and commercializing important new medicines to improve the lives of people with cancer, reported that the Journal of Clinical Oncology has published results from its INTRIGUE Phase 3 study of QINLOCK (ripretinib) in patients with advanced gastrointestinal stromal tumor (GIST) previously treated with imatinib (Press release, Deciphera Pharmaceuticals, AUG 10, 2022, View Source [SID1234618050]). Although QINLOCK did not offer a statistically significant improvement in progression-free survival (PFS) compared to sunitinib, QINLOCK showed meaningful clinical activity with fewer Grade 3/4 treatment-emergent adverse events (TEAEs) and improved tolerability.

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The article, titled "Ripretinib versus sunitinib in patients with advanced gastrointestinal stromal tumor after treatment with imatinib (INTRIGUE): A randomized, open-label, phase III trial" is now available online and will be published in a future print issue of the Journal of Clinical Oncology.

"These full Phase 3 INTRIGUE study results continue to deepen our understanding of QINLOCK and its place in the GIST treatment landscape," said Matthew L. Sherman, M.D., Chief Medical Officer of Deciphera. "Although the INTRIGUE study did not meet its primary endpoint of superiority in PFS compared to sunitinib for patients in the post-imatinib setting, the efficacy of QINLOCK was comparable to sunitinib. In addition, QINLOCK had a more favorable safety profile than sunitinib with fewer Grade 3/4 adverse events and patients in the QINLOCK arm reported less deterioration in role functioning and better outcomes on several other key patient-reported outcome measures of tolerability compared to sunitinib."

INTRIGUE is an international, multi-center study conducted in 122 active sites across 22 countries, where 453 patients with second-line GIST were randomized to receive ripretinib (n=226) or sunitinib (n=227). Key study results include:

In patients with a KIT exon 11 primary mutation, ripretinib demonstrated a median PFS (mPFS) of 8.3 months compared to 7.0 months for the sunitinib arm (Hazard Ratio [HR] 0.88, p=0.36). In the intention-to-treat (ITT) population (n=453), ripretinib demonstrated an mPFS of 8.0 months compared to 8.3 months for the sunitinib arm (HR 1.05, nominal p value=0.72).
In patients with a KIT exon 11 primary mutation, ripretinib demonstrated an objective response rate (ORR) of 23.9% (n=39 of 163) compared to 14.6% (n=24 of 164) for sunitinib (nominal p value=0.03). In the ITT population, ripretinib demonstrated an ORR of 21.7% (n=49 of 226) compared to 17.6% (n=40 of 227) for sunitinib (nominal p value=0.27).
Ripretinib was generally well tolerated. Fewer patients in the ripretinib arm experienced Grade 3/4 treatment-emergent adverse events compared to sunitinib (41.3% vs 65.6%).
Patients receiving sunitinib were three times more likely to develop Grade 3 hypertension compared to patients receiving ripretinib (26.7% vs. 8.5%) and patients receiving sunitinib were seven times more likely to develop Grade 3 palmar-plantar erythrodysesthesia compared to patients receiving ripretinib (10.0% vs. 1.3%).
Patient reported outcome measures also showed a more favorable tolerability profile for patients receiving ripretinib compared to patients receiving sunitinib. Patients receiving ripretinib experienced less deterioration in their ability to engage in either work or leisure activities during treatment, and fewer patients receiving ripretinib experienced moderate to extremely large impact on their lives due to skin toxicity across treatment cycles compared to patients receiving sunitinib.
QINLOCK is approved by the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with advanced GIST who have received prior treatment with three or more kinase inhibitors, including imatinib. The new drug application (NDA) for QINLOCK was based on positive results from the Phase 3 INVICTUS trial in patients with fourth-line and fourth-line plus GIST1.

About QINLOCK (ripretinib)
QINLOCK is a switch-control tyrosine kinase inhibitor that was engineered to broadly inhibit KIT and PDGFRA mutated kinases by using a dual mechanism of action that regulates the kinase switch pocket and activation loop. QINLOCK inhibits primary and secondary KIT mutations in exons 9, 11, 13, 14, 17, and 18 involved in GIST, as well as the primary exon 17 D816V mutation2,3. QINLOCK also inhibits primary PDGFRA mutations in exons 12, 14, and 18, including the exon 18 D842V mutation, involved in a subset of GIST2,3.

On August 10, 2022 VolitionRx Limited (NYSE AMERICAN: VNRX) ("Volition") reported financial results and a business update for the second quarter ended June 30, 2022 (Press release, VolitionRX, AUG 10, 2022, View Source [SID1234618049]). Volition management will host a conference call tomorrow, August 11 at 8:30 a.m. U.S. Eastern Time to discuss these results. Conference call details can be found below.

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"I am delighted with the progress we are making, and in particular could not be prouder of the team’s achievement in securing a CE Mark for Nu.Q NETs in Europe and in announcing new clinical studies for NETosis, or NETs, in the U.S. with both MD Anderson and with Diagnostic Oncology CRO LLC, or DXOCRO. As the only analytically validated test for NETs currently available, we believe that there is enormous potential for Nu.Q NETs to support clinical decision-making, enabling physicians to act quickly, and improve patient outcomes," commented Cameron Reynolds, President and Chief Executive Officer of Volition.

"Following the execution of our global licensing and supply agreement for the Nu.Q Vet Cancer Screening Test with Heska Corporation, the team has been hard at work with the technology transfer program and launch preparation. We also continue to make good progress with other potential licensing and supply partners. Finally, we have recently executed a number of contracts for Nu.Q Discover."

Company Highlights

Financial

Cash and cash equivalents as of June 30, 2022, totaled approximately $16.7 million compared with $20.6 million as of December 31, 2021.
Subsequent to quarter end, Volition received approximately $6.4 million net of underwriter’s fees and expenses in cash through an underwritten public offering of its common stock that closed on August 2.
Secured a further $1.5 million in non-dilutive funding from Namur Invest Capital Risk in Belgium to fund an early access program for Volition’s Nu.Q product portfolio at key sites across the EU, UK, and U.S.
Continued to manage expenditures carefully with net cash used in operating activities averaging approximately $2.1 million per month in the quarter.
Personnel/ Operational

Appointed Sharon Ballesteros as U.S. Head of Quality and Development Process to spearhead Volition’s clinical product development program in the U.S. and expanded her team and operations in California.
Nu.Q NETs

Nu.Q NETs test has been CE marked for the detection and evaluation of NETosis, enabling clinical use in Europe in both ELISA (enzyme-linked immunoassay) and automated ChLIA (ChemiLuminescence ImmunoAssay) formats.
Announced a sponsored research agreement with The University of Texas MD Anderson Cancer Center to evaluate the role of NETS in cancer patients with sepsis.
Appointed DXOCRO to undertake development and clinical validation studies for Volition’s Nu.Q product portfolio in the United States.
DXOCRO will conduct large-scale finding studies across multiple sites in the U.S. using Volition’s Nu.Q NETs and Nu.Q Cancer tests to determine clinical utility in sepsis and cancer.
Volition anticipates that subsequent studies will investigate the chosen intended use claims of the tests, with the objective to gain clearance, authorization, or approval from the United States Food and Drug Administration (the "FDA") and allow the tests to be marketed in the U.S.
These multi-site development studies will help demonstrate how Volition’s Nucleosomics technology can directly benefit patients and support our application to the FDA’s Breakthrough Devices Program and a Pre-submission anticipated in 2023.
In collaboration with researchers at the University of Namur and QUALIblood in Belgium, published:
a clinical paper entitled "NETosis and Nucleosome Biomarkers in Septic Shock and Critical COVID-19 Patients: An Observational Study", and
a poster presentation entitled "Evaluation and comparison of NETosis biomarkers in sepsis and COVID-19 patients" at the International Society on Thrombosis and Haemostasis (ISTH) Congress in July.
Subsequent to quarter end, sponsored a GenomeWeb webinar titled ‘The Promise of Neutrophil Extracellular Traps (NETs) as Biomarkers in Inflammatory Disease’. To watch on demand, visit the GenomeWeb website.
Commenced a Market Access Program with European Key Opinion Leaders and early adopters.
Volition Veterinary

Following the execution of a global licensing and supply agreement with one of the industry’s leading companies, Heska Corporation, started the technology transfer and launch preparations with Heska.
SAGE Healthcare launched the Nu.Q Vet Cancer Test in Singapore.
Advanced negotiations with other potential licensing and supply partners in efforts to make Nu.Q Vet products as accessible as possible worldwide and anticipate further announcements in 2022.
Expanded product claims with the presentation of new clinical data at:
the European Society of Veterinary Oncology Congress in May. To view click here.
the American College of Veterinary Internal Medicine (ACVIM) in June. To view click here.
Expanded access to a larger clinical research laboratory at Texas A&M University and appointed a veterinary emergency criticalist to commence work in non-cancer indications in addition to developing our clinical research network in Europe.
Nu.Q Capture

Nu.Q Capture, when used in combination with either sequencing, mass spectrometry and/or Volition’s Nu.Q assays could potentially aid diagnosis, treatment selection, and both treatment and disease monitoring in addition to aiding biomarker discovery.
The Nu.Q Capture program now has several strands of technology which:
essentially remove background noise, thereby amplifying the signal,
look to identify the signal in a novel way including through mass spectrometry, or
isolate various chromatin fragments, including nucleosomes and transcription factors.
Sponsored a GenomeWeb webinar entitled "Novel Proteomics Approach to Epigenetic Profiling of Circulating Nucleosomes" featuring Professor Axel Imhof. To watch on demand, visit the GenomeWeb website.
Nu.Q Discover

Progressing projects with a range of customers.
Recently signed contracts with three bio-pharmaceutical companies who are accessing our assay portfolio for rapid epigenetic profiling of their drugs in development.
Upcoming Priorities

Drive near term revenue in the following key areas:
Licensing of its technology, with a particular but not exclusive focus on Nu.Q Vet.
Complete Heska Corporation agreement milestones in order to receive further milestone payments.
Sales of key components of Point of Care test with Heska.
Sales of kits from non-exclusive agreements for the use of Nu.Q Vet via central reference labs.
Ongoing and new Nu.Q Discover agreements.
Sales of its disease monitoring tests (e.g. COVID-19, sepsis).
Continue to progress the research program for the use of Nu.Q NETs, in monitoring disease progression of COVID-19, sepsis, and potentially other diseases and as a possible companion diagnostic for the treatment of sepsis.
Continue to advance its previously announced large-scale blood, lung, and colorectal cancer trials in Europe, Asia, and the U.S.
Publish several abstracts and peer-reviewed scientific papers with clinical results showing the robustness and utility of its Nu.Q platform.
Advance the development of Nu.Q Capture.
Continue to file patents to expand and extend its intellectual property portfolio.

Cameron Reynolds, President and Chief Executive Officer of Volition, will host the call along with Terig Hughes, Chief Financial Officer of Volition, Dr. Tom Butera, Chief Executive Officer of Volition Veterinary Diagnostics Development LLC, and Scott Powell, Executive Vice President, Investor Relations of Volition. The call will provide an update on important events which have taken place in the second quarter of 2022 and upcoming milestones.

A live audio webcast of the conference call will also be available on the investor relations page of Volition’s corporate website at View Source In addition, a telephone replay of the call will be available until August 25, 2022. The replay dial-in numbers are 1-844-512-2921 (toll-free) in the U.S. and Canada and 1-412-317-6671 (toll) internationally. Please use replay pin number 13732149.

On August 10, 2022 MaxCyte, Inc., (NASDAQ: MXCT; LSE: MXCT), a leading commercial cell-engineering company focused on providing enabling platform technologies to advance innovative cell-based research as well as next-generation cell therapeutic discovery, development and commercialization, reported financial results for the second quarter and six months ended June 30, 2022 (Press release, MaxCyte, AUG 10, 2022, View Source [SID1234618048]).

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Second Quarter and Recent Highlights

Total revenue of $9.6 million in the second quarter of 2022, an increase of 35% over the second quarter of 2021 driven by strong growth in the cell therapy market; core business revenues grew 45% led by revenue from cell therapy customers which increased 61%, with drug discovery revenues growing by 4%.
Raising 2022 revenue guidance for core business revenue growth to approximately 30%.
Expecting SPL Program-related revenue to be approximately $4 million for the full year.
Total cash, cash equivalents and short-term investments were $240.9 million as of June 30, 2022.
Signed the Company’s 17th SPL agreement in July 2022; LG Chem licensed the use of MaxCyte’s Flow Electroporation ExPERT platform to advance cellular research and development of engineered cell-based therapies.
"We are pleased with these strong second quarter 2022 results, with 45% year-over-year core business revenue growth, highlighted by 61% growth in revenues from Cell Therapy customers. We remain encouraged by the ongoing growth of our SPL portfolio with the addition of LG Chem, our 17th SPL partner, and second SPL agreement signed in 2022, as well as the continued progress of our existing partnerships. Importantly, our LG Chem partnership broadens the reach of our SPL portfolio into Asia," said Doug Doerfler, President and CEO of MaxCyte.

"Overall, our optimism about the potential for the development programs covered by our existing partners to generate growing revenue in both pre-clinical research and clinical progress remains high. Our ExPERT platform continues to be used to enable a broad range of cell types and approaches targeting a wide array of indications, and its adoption is increasing within the industry. We are making ongoing investments to drive revenue growth, support and expand the widening array of applications for our technology, while also strengthening our team and expanding our ability to support customers through in-house manufacturing and robust infrastructure. These investments should allow us to take advantage of expanding markets and support our partners as they move forward in development and commercialization."

Second Quarter 2022 Financial Results

Total revenue for the second quarter of 2022 was $9.6 million, compared to $7.1 million in the second quarter of 2021, representing growth of 35%.

Core business revenue was $9.6 million, including 61% revenue growth from cell therapy customers and 4% from drug discovery customers, compared to core business revenue of $6.6 million in the same period last year.

We did not have any material SPL Program-related revenue in the second quarter of 2022, as compared to $0.5 million in the second quarter of 2021.

Gross profit for the second quarter of 2022 was $8.5 million (88% gross margin), compared to $6.3 million (89% gross margin) in the same period of the prior year.

Operating expenses for the second quarter of 2022 were $17.2 million, compared to operating expenses of $10.7 million in the second quarter of 2021. The overall increase in operating expenses was primarily driven by increased staff in field sales and science, manufacturing, and lab teams to support our customers’ and partners’ growth. The increase also included additional public company-related, stock-based compensation, and marketing expenses compared with the same period a year ago.

Second quarter 2022 net loss was $8.3 million compared to net loss of $4.4 million for the same period in 2021. EBITDA, a non-GAAP measure, was a loss of $8.2 million for the second quarter of 2022, compared to a loss of $4.1 million for the second quarter of the prior year. Stock-based compensation expense was $3.0 million for the second quarter versus $1.9 million for the same period in the prior year.

Total cash, cash equivalents and short-term investments were $240.9 million as of June 30, 2022.

First Half 2022 Financial Results

Total revenue for the first half of 2022 was $21.2 million, compared to $13.6 million in the first half of 2021, representing growth of 56%. Overall sales to the cell therapy (up 59%) and the drug discovery (up 13%) markets were sources of strength in the first half.

The Company recognized $2.0 million of program-related revenue in the first half of 2022, as compared to $0.5 million in program-related revenue in the first half of 2021.

Gross profit for the first half of 2022 was $19.0 million (90% gross margin), compared to $12.1 million (89% gross margin) in the same period of the prior year.

Operating expenses for the first half of 2022 were $31.9 million, compared to operating expenses of $22.9 million in the first half of 2021. The overall increase in operating expenses was primarily driven by increased staff in field sales and science, manufacturing, and lab teams to support our customers’ and partners’ growth. The increase also included additional stock-based compensation, public company-related, and marketing expenses compared with the same period a year ago.

First half 2022 net loss was $12.3 million compared to net loss of $11.5 million for the same period in 2021. EBITDA was a loss of $11.9 million for the first half of 2022, compared to a loss of $10.5 million for the same period of the prior year. Stock-based compensation expense was $5.4 million for the first half of 2022 versus $3.2 million for the same period in the prior year.

2022 Revenue Guidance

We expect core business revenue (instruments and disposables to cell therapy and drug discovery customers and excluding program-related revenue) in 2022 to grow approximately 30% compared to 2021. We continue to expect SPL Program-related revenue to be approximately $4 million in 2022.

Webcast and Conference Call Details

MaxCyte will host a conference call today, August 10, 2022, at 4:30 p.m. Eastern Time. Investors interested in listening to the conference call are required to register online. A live and archived webcast of the event will be available on the "Events" section of the MaxCyte website at View Source

On August 10, 2022 Pulse Biosciences, Inc. (Nasdaq: PLSE), a novel bioelectric medicine company commercializing the CellFX System powered by Nano-Pulse Stimulation (NPS) technology, reported financial results for the second quarter ended June 30, 2022 (Press release, Pulse Biosciences, AUG 10, 2022, View Source [SID1234618047]).

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Company Updates

Continued active engagement and collaboration with the nine commercial clinics participating in the CellFX System utilization program.
Received FDA 510(k) clearance of expanded energy settings for use with the family of CellFX System treatment tips in dermatology.
Generated second quarter 2022 revenue of $265 thousand.
Completed two commercial sales of CellFX Systems in the second quarter of 2022.
Transitioned four Controlled Launch Program participants to commercial use, totaling 43 commercial conversions with 12 clinics remaining in the Controlled Launch program, after a total of 15 clinics opted out, as of the end of Q2.
Reduced Q2 GAAP operating expenses by $3.9 million, or 23%, and Non-GAAP operating expenses by $2.9 million, or 21%, compared to the prior quarter.
Completed a rights offering in June, raising $15.0 million in gross proceeds with the potential to raise additional gross proceeds of up to $15.0 million through the exercise of accompanying warrants.
"In the second quarter, we transitioned our commercial focus toward driving utilization of CellFX Systems in a select group of our dermatology clinics. The development and implementation of best practices for clinic integration is demonstrating more clearly the novel value proposition of our NPS technology for patients and clinicians. Looking forward, we will continue to work closely with this subset of clinics to develop a deep understanding of the factors that drive consistent utilization and adoption of the CellFX System," commented Darrin Uecker, President and CEO of Pulse Biosciences. "At the same time, we continue to work towards expanding indications for the CellFX System to support treatments across specific patient populations and in other medical specialties."

Second Quarter 2022 Results

Revenue for the three months ended June 30, 2022 was $265 thousand, including System revenue of $209 thousand and Cycle Units revenue of $56 thousand. Total revenues of $118 thousand were recognized on a non-cash basis resulting from the Controlled Launch Participants opting to acquire CellFX Systems during the quarter.

Total GAAP cost and expenses representing cost of revenues, research and development, sales and marketing, and general and administrative expenses for the three months ended June 30, 2022 were $14.3 million, compared to $14.8 million for the prior year period. Non-GAAP cost and expenses for the three months ended June 30, 2022 were $12.2 million, compared to $12.1 million for the prior year period. While there were no direct restructuring charges incurred during the quarter, $195 thousand remains in accrued expenses as of June 30, 2022 that will be paid over the remainder of the year.

GAAP net loss for the three months ended June 30, 2022 was ($14.0) million compared to ($15.3) million for the three months ended June 30, 2021. Non-GAAP net loss for the three months ended June 30, 2022 was ($11.9) million compared to ($12.6) million for the three months ended June 30, 2021.

Cash and cash equivalents totaled $14.8 million as of June 30, 2022 compared to $47.4 million as of June 30, 2021 and $12.7 million as of March 31, 2022. Cash used in the second quarter of 2022 totaled $12.8 million excluding net proceeds received in the Company’s June 2022 rights offering. This compares to $15.0 million used in the same period in the prior year and $15.9 million used in the first quarter of 2022.

Reconciliations of GAAP to non-GAAP cost and expenses and net loss have been provided in the tables following the financial statements in this press release. An explanation of these measures is also included below under the heading "Non-GAAP Financial Measures."

Webcast and Conference Call Information

Pulse Biosciences’ management will host a conference call today, August 10, 2022, beginning at 1:30pm PT. Investors interested in listening to the conference call may do so by dialing 1-877-704-4453 for domestic callers or 1-201-389-0920 for international callers. A live and recorded webcast of the event will be available at View Source

On August 10, 2022 Harpoon Therapeutics, Inc. (Nasdaq: HARP), a clinical-stage immunotherapy company developing novel T cell engagers, reported financial results for the second quarter ended June 30, 2022 and provided a corporate update (Press release, Harpoon Therapeutics, AUG 10, 2022, View Source [SID1234618046]).

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"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) Platform

HPN328 (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) (Free ASCO Whitepaper) 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 (AACR) (Free AACR Whitepaper) 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