On May 12, 2022 IN8bio, Inc. (Nasdaq: INAB), a clinical-stage biopharmaceutical company focused on the discovery and development of innovative gamma-delta T cell therapies utilizing its DeltEx platform, reported financial results and operational highlights for the quarter ended March 31, 2022 (Press release, In8bio, MAY 12, 2022, View Source [SID1234614483]). In addition, the Company provided an overview of recent corporate developments.

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"Our team continues to execute and advance our programs on multiple fronts despite these challenging times in biotech," said William Ho, CEO and co-founder of IN8bio. "Our Phase I clinical trials for both DeltEx gamma-delta product candidates, INB-200 in GBM and INB-100 in leukemia patients, continue to progress with encouraging early data. We added key clinical and regulatory expertise to our senior management team and we will be introducing our iPSC derived gamma-delta T cell platform at ASGCT (Free ASGCT Whitepaper) next week. The IN8bio team will continue to be disciplined with our capital and we will use our resources to continue to accelerate the growth and momentum in our Company."

Business Highlights & Updates

In January 2022, IN8bio provided a clinical update from the Phase 1 clinical trial of its genetically modified gamma-delta T cell therapy candidate, INB-200, in newly diagnosed GBM. In the single ascending dose cohort 1 (n=3), all three
patients showed no dose limiting toxicities (DLTs), no cytokine release syndrome (CRS) or neurotoxicity and demonstrated a manageable safety profile. Cohort 2, which will receive three repeat doses of INB-200, includes one patient who has already received all three doses without any DLTs or significant cell therapy related adverse events. All of the patients treated have exceeded their expected progression-free survival (PFS) interval based on age and MGMT status and exceeded median expected PFS of up to seven months with encouraging trends in overall survival.

IN8bio presented a clinical update from the ongoing Phase 1 clinical trial of INB-100, an allogeneic gamma-delta T cell therapeutic candidate in leukemia patients undergoing hematopoietic stem cell transplantation. All three patients treated remain in morphologic CR with durable remissions ranging from nine to 23 months through March 2022. We observed robust immune reconstitution in the patients including T cells, B cells and gamma-delta T cells. INB-100’s safety profile continues to be manageable with no DLTs, no grade 3 or greater graft vs. host disease (GvHD), no CRS and no neurotoxicity. The data were presented at the EBMT 48th Annual Meeting. These are encouraging results given up to 51% are expected to relapse within a year with standard of care treatment.

In April 2022, IN8bio announced the continued expansion of its clinical and regulatory teams with the appointments of Urvashi Patel, Ph.D., Vice President, Regulatory Affairs, and Stacey Bilinski, Vice President, Clinical Operations. They bring deep clinical and regulatory experience to the IN8bio team, from early to late-stage development across the biotechnology and pharmaceutical industry with more than 45 years of combined experience. Dr. Patel has provided regulatory guidance to biopharmaceutical companies, including WindMIL Therapeutics, Precision for Medicine, Janssen, Elan Pharmaceuticals and Genentech. Ms. Bilinski has initiated numerous first in-human and early-phase clinical development programs at biopharmaceutical companies, including Taiho Oncology, Onconova, Insmed, Amicus Therapeutics and Covance.

Upcoming Milestones and Events

In May 2022, IN8bio unveiled a new preclinical program focused on developing iPSC derived gamma-delta T cells to be presented at the ASGCT (Free ASGCT Whitepaper) Annual Meeting, which will be held from May 16-19, 2022. Scalable iPSC-based cellular manufacturing is designed to create for a uniform and renewable therapeutic product available "off-the-shelf" for patients. IN8bio will be holding an investor event via webcast at the conference to introduce the program to the investment community on May 17, 2022, at 6:00 p.m. EDT. A link to the webcast will be available on the Events & Presentations page of the Company’s website.

IN8bio plans to submit an investigational new drug (IND) application for a Phase 1b/2 clinical trial of INB-400 in GBM during the second half of 2022.

Expected Upcoming Presentations

ASGCT 25th Annual Meeting, Washington, D.C., May 2022: introducing a new program on "The Development of Off-the-Shelf" Manufacturing Strategies for iPSC-Based Gamma-Delta T Cells" along with an oral presentation by Dr. Lamb, "Off the Shelf Cell Therapies – Beyond T Cells (Education Session) and The Next Generation of γδ T Cell-based Therapies" by Dr. Lamb.

Advanced Therapies Congress Live, London, May 2022: presenting "New Directions in the Treatment of Solid Tumors with gdT Cells" by Dr. Lamb.

Cambridge Healthcare Immuno-Oncology Therapeutic Development,
London, May 2022: presenting "Genetically Modified gamma delta T cells in
combination with chemotherapy: now in the clinic" by Dr. Lamb

Cell Engager summit, Boston, May 2022: presenting "Gamma-Delta T-cells: Novel approaches to genetic engineering and cell-type specific therapeutic applications" by Dr. Rochlin.

H.C. Wainwright Global Investment Conference, May 2022: Mr. Ho will participate in a fireside chat on May 25, 2022, at 2 p.m. EDT.

American Society for Clinical Oncology (ASCO) (Free ASCO Whitepaper), June 2022: presenting "Phase 1 study of drug-resistant immunotherapy (DRI) with gene-modified autologous γδ T cells in patients with newly diagnosed glioblastoma multiforme (GBM) receiving maintenance temozolomide (TMZ)" by Louis B. Nabors, M.D.

Jefferies Healthcare Conference, June 2022: Mr. Ho will present at 1:30 p.m. EDT on Wednesday, June 8, 2022.

First Quarter 2022 Financial Highlights

Cash position: As of March 31, 2022, the Company had cash of $32.1 million, compared to $37.0 million as of December 31, 2021. The decrease in cash was primarily due to cash used by the Company in research and development and continued operations to advance its programs.

Research and Development (R&D) expenses: R&D expenses were $2.4 million for the three months ended March 31, 2022, compared to $1.2 million for the comparable prior year period. The increase in R&D expenses were primarily due to (i) increased third-party clinical trial and IND-related activities, (ii) contract manufacturing costs for the ongoing INB-200 clinical trial and (iii) increased personnel-related costs, including salaries, benefits and stock-based compensation due to increased headcount.

General and administrative expenses: General and administrative expenses were $3.8 million for the three months ended March 31, 2022, compared to $1.1 million for the comparable prior year period. The increase was primarily
due to increased legal expenses, insurance costs and expenses associated with operating as a public company.

Net loss: The Company reported a net loss attributable to common stockholders of $6.1 million, or $0.33 per basic and diluted common share, for the three months ended March 31, 2022, compared to a net loss attributable to common stockholders of $3.1 million, or $0.82 per basic and diluted common share, for the comparable prior year period.

On May 12, 2022 Xilio Therapeutics, Inc. (Nasdaq: XLO), a biotechnology company developing tumor-selective immuno-oncology therapies for people living with cancer, reported pipeline and business highlights and reported financial results for the first quarter ended March 31, 2022 (Press release, Xilio Therapeutics, MAY 12, 2022, View Source [SID1234614482]).

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"Leveraging our geographically precise solutions (GPS) platform, we are developing a pipeline of tumor-selective immunotherapies that have the potential to achieve meaningful anti-tumor activity while minimizing serious, systemic effects," said René Russo, Pharm.D., president and chief executive officer of Xilio. "We continue to progress enrollment in our Phase 1 clinical programs, XTX101 and XTX202, with planned preliminary data readouts later this year, and we remain on track with our plans to submit an IND application for XTX301 in the second half of 2022. With our strong financial position and an outstanding team in place, we believe we are well-positioned to advance our pipeline of tumor-selective immuno-oncology programs with the goal of transforming the lives of people living with cancer."

Pipeline and Business Progress

Cytokine Programs

Enrollment is ongoing in the Phase 1 clinical trial evaluating XTX202 for the treatment of patients with solid tumors, with preliminary data anticipated to be reported in the second half of 2022. XTX202 is a tumor-selective interleukin-2 (IL-2) designed to localize activity in the tumor microenvironment, with the goal of overcoming the known tolerability challenges of existing IL-2 therapies while achieving enhanced anti-tumor activity as monotherapy and in combination with standard of care agents.
Preclinical data from the XTX301 program was presented at the New York Academy of Sciences Frontiers in Cancer Immunotherapy 2022 conference on May 10, 2022. XTX301 demonstrated tumor-selective activation in patient-derived tumor explants, and a murine surrogate of XTX301 (mXTX301) induced significant tumor growth inhibition in a mouse model and improved tolerability compared to a non-tumor-selective version of mXTX301. View the poster online here.
Xilio continues to anticipate submitting an investigational new drug application (IND) for XTX301, a tumor-selective interleukin-12 (IL-12), in the second half of 2022 for evaluation in patients with solid tumors.

Upcoming Presentations

A trials-in-progress poster outlining details of the ongoing Phase 1/2 clinical trial for XTX202 will be presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2022 Annual Meeting:

Presentation title: A first-in-human, multicenter, phase 1/2, open-label study of XTX202, a masked and tumor-selective recombinant human interleukin-2 (IL-2) protein, in patients with advanced solid tumors
Session date and time: Sunday, June 5, 2022, 8:00-11:00 AM CDT
Abstract number: TPS2697
Checkpoint Inhibitor Program

Enrollment is ongoing in the Phase 1 clinical trial evaluating XTX101, a tumor-selective anti-CTLA-4 monoclonal antibody, as a monotherapy and in combination with pembrolizumab, an anti-PD-1, for the treatment of patients with advanced solid tumors.
Preliminary data for the Phase 1 clinical trial for XTX101 is anticipated to be reported from the monotherapy cohort in the middle of 2022 and from the combination cohort in the second half of 2022.
First Quarter 2022 Financial Results

Cash Position: Cash and cash equivalents were $177.0 million as of March 31, 2022, as compared to $198.1 million as of December 31, 2021. The decrease was primarily driven by cash used in operations for the three months ended March 31, 2022.
Research & Development (R&D) Expenses: R&D expenses were $14.9 million for the first quarter of 2022, compared to $11.6 million for the first quarter of 2021. The increase was primarily driven by increased costs associated with XTX301 and other preclinical programs, as well as higher personnel-related costs due to increased headcount.
General & Administrative (G&A) Expenses: G&A expenses were $6.3 million for the first quarter of 2022, compared to $4.9 million for the first quarter of 2021. The increase was primarily driven by higher personnel-related costs due to increased headcount and other costs related to operating as a publicly traded company.
Net Loss: Net loss was $21.4 million for the first quarter of 2022, compared to $16.7 million for the first quarter of 2021.
Financial Guidance

As a result of prioritization within the company’s preclinical portfolio, Xilio now anticipates that its existing cash and cash equivalents will be sufficient to fund its operating expenses and capital expenditure requirements into the first half of 2024.

On May 12, 2022 Crinetics Pharmaceuticals, Inc. (Nasdaq: CRNX), a clinical stage pharmaceutical company focused on the discovery, development and commercialization of novel therapeutics for rare endocrine diseases and endocrine-related tumors, reported financial results for the first quarter ended March 31, 2022 (Press release, Crinetics Pharmaceuticals, MAY 12, 2022, View Source [SID1234614481]).

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"We continue to build the foundation needed to establish Crinetics as the world’s leading endocrine company, as recent progress has strengthened our clinical dataset, balance sheet and leadership team," said Scott Struthers, Ph.D., founder and chief executive officer of Crinetics. "This is highlighted by CRN04777’s recent Phase 1 top-line results, which further demonstrated the molecule’s dose-dependent effects on biomarkers that are critically important to the pathophysiology and medical management of hyperinsulinism. Later this quarter, we expect to report data from a healthy volunteer study designed to evaluate CRN04894’s potential to counteract the effects of excess ACTH with a novel mechanism of action. The pharmacologic proof-of-concept these Phase 1 studies aim to achieve highlights the unique efficiency of our endocrine drug development paradigm. Looking forward, we will continue to combine the advantages of this paradigm with the efforts of our deeply talented drug discovery team to thoughtfully expand our pipeline as we work to advance our current clinical-stage candidates towards registration."

First Quarter 2022 and Recent Highlights

Reported positive top-line results from multiple-ascending dose (MAD) cohorts of the CRN04777 Phase 1 study. In March 2022, Crinetics announced positive data from the MAD cohorts of a Phase 1 study of CRN04777, a somatostatin receptor type 5 (SST5) agonist being developed as a treatment for congenital and syndromic hyperinsulinisms. The results built upon previously reported pharmacologic proof-of-concept data from the trial’s single-ascending dose (SAD) cohorts, as they showed strong dose-dependent suppression of fasting insulin as well as dose-dependent suppression of sulfonylurea-induced insulin secretion. Pharmacokinetic data indicated CRN04777 was orally bioavailable and supported a once daily dosing schedule. CRN04777 was shown to be well tolerated in the Phase 1 trial, with no dose discontinuations due to adverse events. Crinetics plans to initiate a Phase 2 study of CRN04777 in congenital hyperinsulinism patients in the second half of 2022, following discussions with global regulators.

Entered into strategic licensing agreement with Sanwa Kagaku Kenkyusho Co., Ltd. ("Sanwa") for the development and commercialization of paltusotine in Japan. Crinetics received $13 million upfront in connection with the license agreement and is also eligible to receive payments related to development, regulatory, and commercial milestones. In addition, Crinetics will be eligible to receive tiered royalties on net product sales in Japan should paltusotine receive marketing approval in Japan. In exchange, Sanwa was granted an exclusive right to develop and commercialize paltusotine in Japan and will assume all costs associated with clinical trials and regulatory applications in the territory. Crinetics retains all rights to develop and commercialize paltusotine outside of Japan.

Strengthened balance sheet with successful $125 million common stock offering. In April 2022, Crinetics completed an underwritten follow-on offering of 5,625,563 shares of its common stock at a price to the public of $22.22 per share, raising gross proceeds of approximately $125.0 million.

Strengthened company leadership with appointments to management team and Board of Directors. In the first quarter of 2022, Crinetics built upon its strong leadership and scientific expertise by appointing James Hassard to the role of chief commercial officer, Chris Robillard to the role of chief business officer, and Dr. Rogério Vivaldi Coelho and Caren Deardorf to the Board of Directors.
First Quarter 2022 Financial Results

Research and development expenses were $28.3 million for the three months ended March 31, 2022, compared to $17.6 million for the same period in 2021. The increase was primarily attributable to increased spending on manufacturing and development activities of $7.0 million associated with our clinical and nonclinical activities for paltusotine and our other clinical and preclinical programs, and an increase in personnel costs of $3.0 million, of which stock-based compensation was $1.4 million.

General and administrative expenses were $8.7 million for the three months ended March 31, 2022, compared to $5.3 million for the same period in 2021. The increase was primarily attributable to an increase in personnel costs of $2.1 million, of which stock compensation was $1.0 million.

Net loss for the three months ended March 31, 2022, was $34.6 million, compared to a net loss of $22.9 million for the same period in 2021.

Revenues were $3.1 million for the three months ended March 31, 2022, consisting of license revenue recognized from the Sanwa license agreement.

Unrestricted cash, cash equivalents and investments totaled $319.7 million as of March 31, 2022, compared to $333.7 million as of December 31, 2021. The $319.7 million in unrestricted cash, cash equivalents and investments does not include the $125.0 million in gross proceeds from the company’s April 2022 common stock offering. Based on its current plans, the company expects that current cash, cash equivalents and short-term investments will fund its current operating plan into the second half of 2024.

The company had 53,505,809 common shares outstanding as of May 9, 2022.

On May 12, 2022 Molecular Templates, Inc. (Nasdaq: MTEM, "Molecular Templates," or "MTEM"), a clinical-stage biopharmaceutical company focused on the discovery and development of proprietary targeted biologic therapeutics, engineered toxin bodies (ETBs), reported financial results for the first quarter of 2022 (Press release, Molecular Templates, MAY 12, 2022, View Source [SID1234614480]).

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"We continue to make meaningful progress in advancing our pipeline of ETBs," said Eric Poma, Ph.D., Chief Executive and Chief Scientific Officer of Molecular Templates. "We recently commenced dosing in Cohort 3 of our Phase 1 study of MT-6402 in PD-L1+ patients. We intend to report additional data from this study in the second half of the year. Dose finding in the MT-5111 and MT-0169 programs is ongoing with clinical data expected this year. We look forward to continued momentum across our pipeline in 2022, including filing an IND for MT-8421, our ETB targeting CTLA-4, and advancing our earlier stage pipeline of ETBs targeting TIGIT, TROP-2, and BCMA."

Company Highlights and Upcoming Milestones

Corporate

MTEM expects to provide periodic updates on MT-6402, MT-5111, and MT-0169 throughout 2022.
MTEM hosted a webinar on MT-6402 (PD-L1 ETB with Antigen Seeding Technology) with David Spigel, M.D. of the Sarah Cannon Research Institute on April 13. A replay of the event (including slides) can be accessed here.
Abstracts on MT-6402 and MT-5111 (HER2 ETB) have been accepted for presentation at the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting, to take place June 3-7, 2022, in Chicago, IL.
Gabriela Gruia, M.D. appointed to Board of Directors.
Megan Filoon promoted to General Counsel.
Immuno-oncology ETBs:

MT-6402 (PD-L1 ETB with Antigen Seeding Technology)

Patient enrollment continues in the Phase 1 study of MT-6402 which began in July 2021. MT-6402 is a 3rd generation ETB designed to induce potent anti-tumor effects via PD-L1 targeting through multiple mechanisms that may overcome the limitations of approved checkpoint inhibitors.
The Phase 1 study is a multi-center, open-label, dose escalation and dose expansion trial in the United States. Patients with confirmed PD-L1 expressing tumors or confirmed PD-L1 expression in the tumor microenvironment (TME) are eligible for enrollment.
As of March 2022, twelve patients with relapsed/refractory tumors that express PD-L1 have been treated to date across two dose cohorts: 16 mcg/kg (n=6) and 24 mcg/kg (n=6). Dosing continues with three patients currently enrolled in the 32 mcg/kg cohort (cohort 3).
One patient in cohort 1 (16 mcg/kg) with non-small cell lung cancer (NSCLC) that had progressed after prior checkpoint therapy (PD-1 and CTLA-4) had evaluable-only multiple sites of bone disease that appeared to have resolved on bone scan with only one remaining site which showed decreased uptake. This patient remained on MT-6402 up to cycle 8 when increased uptake was noted on bone scan and treatment was discontinued.
The 16 mcg/kg cohort was completed with no dose-limiting toxicities (DLTs) observed. One DLT was observed in a single patient in cohort 2 (24 mcg/kg). The patient experienced dermatitis that resolved rapidly with systemic steroids. The patient was rechallenged without incident at 24 mcg/kg. No other DLTs have been reported.
Following determination of the maximum tolerated dose (MTD), MTEM plans expansion cohorts to evaluate MT-6402 as a monotherapy in tumor-specific and PD-L1 positive basket tumor cohorts.
MTEM continues to observe pharmacodynamic (PD) effects including monocyte depletion and T cell activation in the 24 mcg/kg cohort. The extent and timing of these PD effects appear dose-related with patients in the 24 mcg/kg generally showing a more rapid and profound PD effect, including monocyte depletion and T cell activation, potentially in a dose-dependent manner.
These PD effects associated with immune activation were seen across the majority of patients irrespective of HLA type or level of tumor PD-L1 staining. The patient that demonstrated tumor regression was one of two patients treated with high tumor PD-L1 expression and may represent engagement of direct tumor cell-kill and antigen seeding.
MT-8421 (CTLA-4 ETB)

Preclinical data from MTEM’s CTLA-4 program were featured in a poster at the AACR (Free AACR Whitepaper) annual meeting held April 8-13, 2022. In a transgenic mouse model expressing human CTLA-4 and bearing syngeneic subcutaneous tumors, MT-8421 treatment depleted immune suppressive regulatory T cells (Tregs) in the TME.
MT-8421 was well tolerated in a non-human primate toxicology study and achieved serum levels well-above projected IC50 concentrations for Tregs in the TME.
IND filing for MT-8421 is expected in 2H22, with clinical studies expected to commence in 2023.
MT-6402 and MT-8421 represent MTEM’s unique approach to immuno-oncology based on dismantling the TME through direct cell-kill of tumor and immune cells and not just the blocking of ligand-ligand interactions seen with current antibody therapeutics.
Research

MTEM continues to expand its unique approach to immuno-oncology targets with lead optimization on a TIGIT-targeting ETB on-going and additional exploration around new immuno-oncology targets.
Targeted Solid Tumor ETBs:

MT-5111 (HER2 ETB)

The Phase 1 study of MT-5111 in HER2-positive cancers is ongoing with multiple sites open for enrollment.
The HER2-positive breast cancer expansion cohort initiated in November 2021 at a dose of 10 mcg/kg.
As of January 2022, 30 patients had been treated with MT-5111 across eight dose escalation cohorts ranging from 0.5 mcg/kg to 13 mcg/kg without any DLTs. Enrollment in the 17 mcg/kg cohort has been initiated.
Dose escalation will continue to determine the MTD, while the breast cancer expansion cohort collects efficacy and safety data.
No signs of capillary leak syndrome (CLS) or significant cardiotoxicity have been observed to date with MT-5111.
Research

Lead optimization on a 3rd generation ETB targeting TROP-2 continues.
Hematologic Malignancy Targeted ETBs:

MT-0169 (CD38 ETB)

The revised protocol for the ongoing Phase 1 study in patients with relapsed/refractory multiple myeloma or non-Hodgkin’s lymphoma is now open. The revised protocol will explore a lower dose of MT-0169 to reduce the risk of adverse events observed at the initial dose and to enable patients to continue MT-0169 therapy for a longer duration that may drive tumor benefit. Importantly, the robust and rapid NK cell depletion that was observed at the starting dose is expected to be observed at lower doses.
MTEM is opening new sites for the Phase 1 study and anticipates enrollment beginning in the second quarter of 2022.
Research

Lead optimization on BCMA, SLAMF-7, and CD45 continues.
Financial Results

The net loss attributable to common shareholders for the first quarter of 2022 was $21.6 million, or $0.38 per basic and diluted share. This compares with a net loss attributable to common shareholders of $26.8 million, or $0.51 per basic and diluted share, for the same period in 2021.

Revenues for the first quarter of 2022 were $8.5 million, compared to $3.2 million for the same period in 2021. Revenues for the first quarter of 2022 were comprised of revenues from collaborative research and development agreements with Takeda and Bristol Myers Squibb.

Total research and development expenses for the first quarter of 2022 were $21.5 million, compared with $21.4 million for the same period in 2021. Total general and administrative expenses for the first quarter of 2022 were $7.6 million, compared with $8.2 million for the same period in 2021.

As of March 31, 2022, MTEM’s cash and investments totaled $124.5 million. MTEM’s current cash and investments are expected to fund operations to the end of 2023.

For more details on MTEM’s financial results for the first quarter 2022, refer to Form 10Q filed with the SEC.

On May 12, 2022 Harpoon Therapeutics, Inc. (Nasdaq: HARP), a clinical-stage immunotherapy company developing novel T cell engagers, reported financial results for the first quarter ended March 31, 2022 and provided a corporate update (Press release, Harpoon Therapeutics, MAY 12, 2022, View Source [SID1234614479]).

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"We continue to advance our robust pipeline of T cell engagers and explore their therapeutic potential in areas of unmet medical need," said Julie Eastland, President and Chief Executive Officer of Harpoon Therapeutics. "We anticipate upcoming milestones in the second half of the year for our lead programs from our TriTAC platform and our next generation ProTriTAC T cell engager HPN601 in solid tumors. We look forward to sharing our progress as we work to bring these important therapeutic options to patients."

First Quarter 2022 Recent Highlights and Upcoming Milestones

Enrollment continues across Harpoon’s portfolio of novel T cell engagers for the treatment of cancer:

Tri-specific T cell Activating Construct (TriTAC) Platform

HPN328 (DLL3) Phase 1/2 trial in small cell lung cancer (SCLC) and neuroendocrine cancers

Harpoon plans to present interim clinical results from the ongoing Phase 1 part of the study in a poster presentation at the upcoming American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting 2022 on June 6 at 8:00 a.m. CT.
In May 2022, Harpoon entered into a Master Clinical Supply Agreement with F. Hoffmann-La Roche Ltd for the supply of atezolizumab (Tecentriq) for use in the Company’s planned clinical trials to evaluate HPN328 in combination with atezolizumab for the treatment of patients with SCLC.
In March 2022, the U.S. Food and Drug Administration (FDA) granted Orphan Drug designation to HPN328 for the treatment of patients with SCLC.
Harpoon is continuing dose escalation with the goal to identify expansion dose(s) by year-end 2022.
HPN217 (BCMA) Phase 1/2 trial for relapsed, refractory multiple myeloma

In March 2022, the FDA granted Fast Track designation to HPN217 for the treatment of patients with relapsed, refractory multiple myeloma.
Compelling initial clinical activity observed in dose escalation phase of ongoing trial. Maximum tolerated dose (MTD) has not been reached and enrollment in escalation cohorts continues in first half of 2022.
Harpoon plans to initiate a Phase 2 dose expansion trial in the second half of 2022.
HPN536 (MSLN) Phase 1/2a trial for tumors expressing mesothelin

The dose escalation phase of the ongoing Phase 1/2a clinical trial for cancers expressing mesothelin is ongoing and is expected to be complete by year-end 2022.
ProTriTAC

ProTriTAC is a conditionally active T cell engager platform that is designed to be preferentially active in the tumor. This enables our 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, including gastrointestinal cancers, potentially enabling HPN601 to address multiple indications with high unmet medical need.
Harpoon expects to advance HPN601 with an IND submission in the second half of 2022.

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 can 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.
First Quarter 2022 Financial Results

Harpoon ended the first quarter of 2022 with $112.5 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 through the first half of 2023.

Revenue for the quarter ended March 31, 2022 was $5.9 million, compared to $9.0 million for the quarter ended March 31, 2021. The decrease in revenue was primarily due to lower revenue recognized from the Amended and Restated Discovery Collaboration Agreement with AbbVie.

Research and development (R&D) expense for the quarter ended March 31, 2022 was $20.8 million, compared to $16.2 million for the quarter ended March 31, 2021. The increase primarily arose from higher clinical development and personnel-related expense, which included conducting preclinical studies and clinical trials for HPN328, HPN217 and HPN536.

General and administrative (G&A) expense for the quarter ended March 31, 2022 was $5.4 million, compared to $4.6 million for the quarter ended March 31, 2021. The increase was primarily attributable to an increase in personnel expenses related to an increase in headcount and other professional services to support Harpoon’s operations as a public company.

Net loss for the quarter ended March 31, 2022 was $20.3 million, compared to $61.7 million for the quarter ended March 31, 2021. The prior year period included a $50 million legal settlement expense.