Forty Seven Inc. Reports First Quarter 2019 Financial Results and Recent Business Highlights
-- Updated Data from Phase 1b/2 Trial of 5F9 in Combination with Rituximab in r/r
– Updated Data from Phase 1b Trial of 5F9 as Monotherapy and in Combination with Azacitidine in AML and MDS to be Presented at
-- Entered into Collaborations with
-- Management to Host Conference Call at
“Our achievements year-to-date reflect our commitment to maximizing the potential of 5F9 as a novel, first-in-class therapeutic for the treatment of cancer,” said
First Quarter and Recent Business Highlights:
May 2019, Forty Seven entered into a collaboration with Acerta Pharma, AstraZeneca’s hematology research and development center of excellence, to evaluate 5F9 in combination with rituximab plus AstraZeneca/Acerta Pharma’s Bruton’s tyrosine kinase (BTK) inhibitor, acalabrutinib (CALQUENCE®), in patients with diffuse large B-cell lymphoma (DLBCL). This approach aims to optimize the treatment of DLBCL patients by inhibiting BTK. In B-cells, BTK signaling results in the activation of pathways associated with B-cell proliferation, trafficking, chemotaxis and adhesion, and BTK inhibition is a proven strategy for inducing the regression of B-cell lymphomas.
April 2019, Forty Seven extended its existing collaboration with Genentech, a member of the Roche Group, to include a third clinical trial evaluating 5F9 in combination with rituximab plus Genentech’s anti-PD-L1 antibody, atezolizumab (TECENTRIQ®), in patients with DLBCL. This approach aims to optimize the treatment of DLBCL patients whose tumors are associated with high levels of macrophages expressing PD-L1.
- Forty Seven plans to present updated data from the Phase 1b/2 trial of 5F9 in combination with rituximab in patients with relapsed or refractory non-Hodgkin’s lymphoma (r/r
NHL), including safety, efficacy and duration of response across various dosing cohorts, at the 24th Congressof the European Hematology Association(EHA) and the International Conference on Malignant Lymphoma(ICML) meetings in June 2019.
- Forty Seven plans to present safety and initial efficacy data from the Phase 1b trial evaluating 5F9 as a monotherapy and in combination with azacitidine in patients with acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS) at the 2019
American Society of Clinical Oncology( ASCO) Annual Meeting and the 24th Congressof the EHA in June 2019.
Additionally, the company expects to achieve the following milestones by the end of 2019:
- Report data from the Phase 1b trial of 5F9 in combination with avelumab in patients with ovarian cancer in the fourth quarter.
- Report data from the Phase 1b trial of 5F9 in combination with cetuximab in patients with colorectal cancer in the fourth quarter.
- Report preclinical data and complete investigational new drug (IND)-enabling studies for FSI-174, an anti-cKIT antibody with potential use as a novel conditioning regimen for bone marrow transplantation, in the second half.
- Complete IND-enabling studies for FSI-189, an anti-SIRPα antibody with therapeutic potential for cancer and other indications, in the second half.
First Quarter 2019 Financial Results:
- Cash Position: As of
March 31, 2019, cash, cash equivalents and short-term investments were $113.6 million, as compared to $139.0 millionas of December 31, 2018. This decrease reflects cash used to fund operating activities, including approximately $7.7 millionin an advance payment for contract manufacturing, in the first quarter of 2019. The company expects that its cash, cash equivalents and short-term investments will fund operating expenses and capital expenditure requirements through the first half of 2020.
- R&D Expenses: R&D expenses were
$19.1 millionfor the first quarter of 2019, as compared to $11.2 millionfor the first quarter of 2018. The increase was primarily due to a $3.7 millionincrease in third-party costs related to advancing the company’s clinical development programs for 5F9 and associated contract manufacturing costs Additionally, there was an increase of $2.8 millionin costs associated with the advancement of the company’s preclinical and discovery programs, and an increase of $1.4 millionin personnel-related costs, including stock-based compensation.
- G&A Expenses: G&A expenses were
$4.6 millionfor the first quarter of 2019, as compared to $3.8 millionfor the first quarter of 2018. The increase was primarily due to a $0.9 millionincrease in personnel-related costs driven by an increase in headcount and a $0.2 millionincrease in directors and officers insurance expense, partially offset by a $0.4 milliondecrease in accounting and consulting expenses incurred in connection with operating as a public company.
- Net Loss: Net loss was
$23.0 millionfor the first quarter of 2019, or a net loss per share of $0.74, as compared to $14.8 millionfor the first quarter of 2018, or a net loss per share of $2.24.
Conference Call Information:
Forty Seven will host a live conference call and webcast at 4:30 p.m. ET today to discuss first quarter 2019 financial results and recent business activities. The conference call may be accessed by (866) 953-0780 (domestic) or (630) 652-5854 (international), and by referring to conference ID 4283836. A webcast of the conference call will be available in the Investors section of the Forty Seven website at https://ir.fortyseveninc.com. The archived webcast will be available on Forty Seven’s website approximately two hours after the conference call and will be available for 30 days following the call.
Forward Looking Statements:
Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "may," "will," "expect," "anticipate," "estimate," "intend," and similar expressions (as well as other words or expressions referencing future events, conditions, or circumstances) are intended to identify forward-looking statements. These statements include those related to the presentation of, timing of and outcome of results from the Phase 1b/2 trial of 5F9 in combination with rituximab in patients with r/r
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|Forty Seven, Inc.|
|Statement of Operations Data|
|(In thousands, except share and per share data)|
|Three Months Ended
|Research and development||$||19,126||$||11,153|
|General and administrative||4,584||3,843|
|Total operating expenses||23,710||14,996|
|Loss from operations||(23,710||)||(14,996||)|
|Interest and other income, net||694||221|
|Net loss per share, basic and diluted||$||(0.74||)||$||(2.24||)|
|Shares used in computing net loss per share, basic and diluted||31,166,184||6,600,407|
|Forty Seven, Inc.|
|Selected Balance Sheet Data|
|March 31, 2019||December 31, 2018|
|Cash, cash equivalents and short-term investments||$||113,589||$||139,023|
|Total stockholders’ equity||112,899||133,221|
Source: Forty Seven, Inc.