Unum Therapeutics Reports Fourth Quarter and Full Year 2018 Financial Results and Provides Business Update
- Advancing ATTCK-20-03 Phase 1 Trial in CD20+ Non-Hodgkin Lymphoma Toward Expansion Phase; Completing ATTCK-20-2 Study -
- Continued Dose Escalation of ATTCK-17-01 Trial in Multiple Myeloma -
- First Solid Tumor Trial, ATTCK-34-01, Initiated in HER2+ Advanced Cancers –
- Expanding Solid Tumor Pipeline with BOXR1030 Advancing as the First Product Candidate from the BOXR Platform –
- Extended Cash Runway into Early 2021 -
“2018 was an important year for
- Continuing Dose Escalation in ATTCK-20-03 Phase I Trial: At the 2018
American Society of Hematology(ASH) Annual Meeting in December, Unumpresented preliminary results from the first two dose levels of its ongoing Phase 1 study of ACTR707 in combination with rituximab in patients with relapsed/refractory CD20+ B cell non-Hodgkin lymphoma (r/r NHL). These data demonstrated that three of the six patients treated at Dose Level 1 (25 MM ACTR+ T cells) and one of three patients treated at Dose Level 2 (40 MM ACTR+ T cells) achieved a complete response. Enrollment and dose-limiting toxicity (DLT) assessments at Dose Level 3 (55 MM ACTR+ T cells) have since been completed, and enrollment at Dose Level 4 (80 MM ACTR+ T cells) has initiated. Through the first three cohorts, no DLTs and no severe adverse events of cytokine release syndrome (CRS) or neurologic events have been observed. Following completion of the dose escalation phase of the trial, Unumplans to initiate a cohort expansion at the preliminary recommended Phase 2 dose of ACTR707 in the second half of 2019.
- Completed Enrollment of ATTCK-20-2 Phase I Trial: Following the decision in 2018 to prioritize ACTR707 for future development in r/r
NHL, Unumhas completed enrollment 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. Unumplans to report data on all enrolled patients from ATTCK-20-2 at the end of 2019. These data will inform other ACTR programs, specifically ATTCK-17-01, a Phase I trial of ACTR087 in combination with SEA-BCMA.
- Continuing Dose Escalation with ATTCK-17-01 Phase I Trial: At the 2018 ASH Annual Meeting in December,
Unumpresented data from the initial cohorts of the ongoing Phase 1 ATTCK-17-01 study, testing ACTR087 in combination with SEA-BCMA (an investigational monoclonal antibody targeting B cell maturation antigen, or BCMA) in patients with relapsed/refractory multiple myeloma (r/r MM). In the first three cohorts, no DLTs and no severe adverse events of CRS or neurologic events were observed. Having cleared cohorts with very low levels of SEA-BCMA antibody administered, dose escalation is continuing now at doses of SEA-BCMA that may be expected to have pharmacological activity based upon preclinical studies. Enrollment at Dose Level 4 (30 MM ACTR+ T cells and 2.0 mg/kg SEA-BCMA) is ongoing. In subsequent dose cohorts, the dose of both ACTR087 and SEA-BCMA will be explored. Unumexpects 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.
- Initiated ATTCK-34-01 Phase I Trial in Solid Tumors:
Unumannounced that it has initiated ATTCK-34-01, 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. This is Unum’s first ACTR T cell study in solid tumors. The primary study objectives are to assess the safety and tolerability of the combination, and to define dose recommendations for further development. Additional objectives include assessment of anti-tumor activity, ACTR T cell persistence, and trastuzumab pharmacokinetics. Unumplans to report initial clinical data from the ongoing dose escalation at the end of 2019.
Initiated Preclinical Developmentof the First Product Candidate from the BOXR Platform: In November 2018, Unumannounced its new Bolt-On Chimeric Receptor technology platform (BOXR), which improves T cell functionality by countering immunosuppression in solid tumor cancers. Unumpresented preclinical data at the 2018 Society for Immunotherapy of Cancermeeting demonstrating the ability to significantly improve the activity of both ACTR- and CAR-targeted engineered T cells in immunosuppressive solid tumors. Unumhas subsequently nominated BOXR1030 as the first product candidate from this platform and has initiated IND-enabling preclinical studies and plans to present additional information regarding BOXR1030 in the second half of 2019. BOXR1030 consists of a T cell co-expressing a glypican-3 (GPC3)-directed CAR and an undisclosed metabolism-enhancing bolt-on transgene. GPC3 is a well-known oncofetal antigen selectively expressed in a variety of tumor types including certain liver and lung cancers.
Fourth Quarter 2018 Financial Results
- Collaboration Revenue: Collaboration revenue recognized during the fourth quarter ended
December 31, 2018was $3.8 million, compared to $2.1 millionin the same period of 2017. The increase reflects the recognition of a portion of the $25.0 million upfront payment received from Seattle Geneticsunder Unum’s collaboration agreement as well as reimbursements of research and development costs attributed to the ATTCK-17-01 study.
- R&D Expenses: Research and development expenses were
$10.8 million for the fourth quarter ended December 31, 2018, compared to $7.6 million for the same period of 2017. 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 fourth quarter ended
December 31, 2018, were $2.0 million, compared to $1.4 million for the same period of 2017. The increase is primarily due to expenses around operating as a public company and higher personnel related costs.
- Net Loss: Net loss attributable to common stockholders was $8.6 million, or $0.29 per share, for the fourth quarter ended
December 31, 2018, and $6.7 million, or $0.66 per share, for the same period of 2017.
Cash Equivalents and Marketable Securities: As of December 31, 2018, Unumhad cash, cash equivalents, and marketable securities of $78.6 million. Total cash burn for 2018, net of IPO related costs, was $36.3 million. Today, Unumupdated its cash runway and now anticipates 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
Forward looking Statements
This press release contains forward-looking statements. Statements in this press release about our future expectations, plans and prospects, including projections regarding future revenues and financial performance, our long-term growth, the anticipated timing of our clinical trials and regulatory filings, the development of our product candidates, including the lead ACTR product candidates and the BOXR platform and product candidates, as well as other statements containing the words "anticipate," "believe," "continue," "could," "estimate," "expect," "intend," "may," "might," "plan," "potential," "predict," "project," "should," "target," "will," or "would" and similar expressions, constitute forward-looking statements within the meaning of the safe harbor provisions of The Private Securities Litigation Reform Act of 1995. We may not actually achieve the forecasts disclosed in our forward-looking statements, and you should not place undue reliance on our forward-looking statements. Actual results could differ materially from the projections disclosed in the forward-looking statements we make as a result of a variety of risks and uncertainties, including risks related to the accuracy of our estimates regarding expenses, future revenues, capital requirements, and the need for additional financing, the success, cost and timing of our product development activities and clinical trials, our ability to obtain and maintain regulatory approval for our product candidates, and the other risks and uncertainties described in the "Risk Factors" sections of our public filings with the
Stern Investor Relations, Inc.
CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except share and per share amounts)
|Year Ended December 31,|
|Research and development||38,285||29,832|
|General and administrative||7,454||4,680|
|Total operating expenses||45,739||34,512|
|Loss from operations||(36,005||)||(26,152||)|
|Other income (expense):|
|Other income, net||320||274|
|Total other income, net||1,473||660|
|Accretion of redeemable convertible preferred stock
to redemption value
|Net loss attributable to common stockholders||$||(34,548||)||$||(25,557||)|
|Net loss per share attributable to common stockholders,
basic and diluted
|Weighted average common shares outstanding, basic
CONSOLIDATED BALANCE SHEET DATA
|December 31, 2018||December 31, 2017|
|Cash, cash equivalents and marketable securities||$||78,594||$||40,961|
|Redeemable convertible preferred stock||—||77,151|
|Total stockholders' equity (deficit)||60,234||(48,846||)|
Source: Unum Therapeutics Inc.