On May 13, 2019 Unum Therapeutics Inc. (NASDAQ: UMRX), a clinical-stage biopharmaceutical company focused on the development of cellular immunotherapies to treat cancer based on its novel T cell technology platforms, reported financial results and provided a corporate update for the first quarter ended March 31, 2019, and recent activities (Press release, Unum Therapeutics, MAY 13, 2019, View Source [SID1234536207]).

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"We remain on track to deliver on key milestones across our pipeline of hematologic and solid tumor cancer programs," said Chuck Wilson, President and CEO of Unum. "The dose escalation phases of our non-Hodgkin lymphoma, multiple myeloma, and HER2+ advanced cancer trials based on our Antibody-Coupled T cell Receptor (ACTR) platform are proceeding as planned, positioning us to report data and drive decisions on next steps. Simultaneously, we continue to advance and expand our preclinical pipeline of Bolt-On Chimeric Receptor (BOXR) programs, aiming to address the unmet need in solid tumor cancers by engineering improved T cell functionality."

Recent Highlights

Dose Escalation in ATTCK-20-03 Phase I Trial in Non-Hodgkin Lymphoma Continuing: Building upon results from the first two dose cohorts presented at the 2018 American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in December, Unum has continued dose escalation in Cohorts 3 and 4 in its ongoing Phase I study of ACTR707 in combination with rituximab in patients with relapsed/refractory CD20+ B cell non-Hodgkin lymphoma (r/r NHL). Cohort 3 has completed enrollment and dosed patients with 55M ACTR+ T cells, whereas Cohort 4 enrollment and dosing of patients with 80M ACTR+ T cells is ongoing. As of May 7, 2019, no dose-limiting toxicities (DLTs) and no severe adverse events of cytokine release syndrome (CRS) or neurologic events have been reported. Unum plans to complete dose escalation in the second half of 2019 and subsequently to initiate safety expansion at the preliminary recommended Phase II dose of ACTR707. Unum plans to report results from the dose escalation phase in late 2019.

Expansion Cohort in ATTCK-20-2 Phase I Trial in Non-Hodgkin Lymphoma Ongoing: Enrollment has completed in the ATTCK-20-2 study, a Phase I clinical trial evaluating safety and anti-lymphoma activity of ACTR087 in combination with rituximab in patients with r/r NHL. Unum is continuing ACTR087 treatment, safety, and response assessments in the expansion cohort at the preliminary recommended Phase II dose (35M ACTR+ T cells). No severe adverse events of CRS or neurologic events have been observed as of May 7, 2019. Unum plans to report data on all enrolled patients from ATTCK-20-2 at the end of 2019. These findings will be used to advise other ACTR programs, in particular ATTCK-17-01, an ongoing Phase I trial of ACTR087 in combination with SEA-BCMA.

Dose Escalation in ATTCK-17-01 Phase I Trial in Multiple Myeloma Continuing: After reporting data at the 2018 ASH (Free ASH Whitepaper) Annual Meeting from the first three dose cohorts in the ATTCK-17-01 study, combining ACTR087 with very low doses of SEA-BCMA antibody, dose escalation is continuing at doses of SEA-BCMA that may be expected to have pharmacological activity based upon preclinical studies. Enrollment and dosing of patients at Dose Level 4 (30 MM ACTR+ T cells and 2.0 mg/kg SEA-BCMA) has completed, and enrollment and dosing of patients at Dose Level 5 (50M ACTR+ T cells and 2.0 mg/kg SEA-BCMA) is ongoing. As of May 7, 2019, no DLTs and no severe adverse events of CRS or neurologic events have been reported in this trial. Unum expects to continue to enroll and dose patients through the dose escalation phase of the trial and to report data from multiple dose cohorts in the second half of 2019.

Dose Escalation with ATTCK-34-01 Phase I Trial in HER2+ Advanced Cancers Ongoing: In December, 2018, Unum initiated the first clinical site in the ATTCK-34-01 study, a Phase 1, multicenter, single-arm, open-label dose escalation study evaluating ACTR T cells in combination with trastuzumab for the treatment of patients with HER2+ advanced cancers. Enrollment, dosing, and assessment of patients in the first dose cohort are ongoing. As of May 7, 2019, no DLTs or severe adverse events of CRS or neurologic events have been reported in this trial. Unum plans to report initial clinical data from ATTCK-34-01 at the end of 2019.

Preclinical Development of BOXR1030 Targeting GPC3+ Advanced Cancers Ongoing: Earlier this year, Unum nominated BOXR1030 as the first product candidate from their BOXR platform, which seeks to counter immunosuppression, improving T cell functionality for solid tumors. IND-enabling preclinical studies of BOXR1030 are underway, as well as research to characterize its mechanism of action. Unum plans to present additional data regarding BOXR1030 in the second half of 2019.

First Quarter 2019 Financial Results

Collaboration Revenue: Collaboration revenue recognized during the first quarter ended March 31, 2019 was $3.1 million, compared to $2.2 million in the same period of 2018. The increase reflects the recognition of a portion of the $25.0 million upfront payment received from Seattle Genetics under Unum’s collaboration agreement as well as reimbursements of research and development costs attributed to the collaboration agreement.

R&D Expenses: Research and development expenses were $12.4 million for the first quarter ended March 31, 2019, compared to $8.1 million for the same period of 2018. The increase reflects higher clinical trial costs for the active Phase I clinical trials, as well as increased personnel-related costs, materials and facility-related costs related to scaling manufacturing processes, and increased consultant costs to support these activities.

G&A Expenses: General and administrative expenses for the first quarter ended March 31, 2019, were $2.5 million, compared to $1.1 million for the same period of 2018. The increase is primarily related to higher personnel related costs due to increased headcount and increased expenses around operating as a public company.

Net Loss: Net loss attributable to common stockholders was $11.7 million, or $0.39 per share, for the first quarter ended March 31, 2019, and $6.8 million, or $0.66 per share, for the same period of 2018.

Cash, Cash Equivalents and Marketable Securities: As of March 31, 2019, Unum had cash, cash equivalents, and marketable securities of $67.1 million. Unum believes that its existing cash, cash equivalents, and marketable securities, will fund operating expenses and capital expenditure requirements into early 2021.

Investor Call and Webcast Information

Unum will host a live conference call and webcast today, May 13, 2019, at 8:00 a.m. ET, to discuss these financial results and company updates. To access the call, please dial 866-300-3411 (domestic) or 636-812-6658 (international) and refer to conference ID number 1443149. A webcast will be available at View Source at least 10 minutes before the event begins. The archived webcast will be available at the same location approximately two hours after the event and will be archived for 90 days.