Xencor Reports Fourth Quarter and Full Year 2018 Financial Results
"In 2018, we rapidly expanded our bispecific antibody oncology pipeline to position ourselves at the forefront of this growing field, starting two Phase 1 programs and submitting INDs for an additional two for which we will soon begin dosing patients. We also reported encouraging initial data from the Phase 1 study of XmAb14045 in patients with acute myeloid leukemia, and we are now working with the
Dr. Dahiyat added, "Given our focus on the growing opportunities provided by our bispecific Fc technology, we do not plan to start late-stage clinical development for obexelimab, which has demonstrated disease modifying activity in lupus and IgG4-related disease, prior to securing a partner. This approach will allow us to maximize the drug candidate's potential for the broadest set of patients."
Recent Business Highlights and Upcoming Clinical Plans
XmAb®14045: XmAb14045 is a CD123 x CD3 bispecific antibody being evaluated through a Phase 1 study in patients with relapsed or refractory acute myeloid leukemia and other CD123-expressing hematologic malignancies.
- Partial Clinical Hold: On
February 20, 2019 ,Xencor announced that theU.S. Food and Drug Administration (FDA ) had placed a partial clinical hold on the Phase 1 study pending review of additional details regarding two patient deaths, safety and efficacy information across the study, and satisfactory review of amendments to the study protocol and related documents. One patient experienced cytokine release syndrome (CRS) after their first dose, the treatment of which was complicated by the patient's decision to withdraw care. Another patient developed acute pulmonary edema following several doses of XmAb14045.Xencor is coordinating a response to the partial hold by theFDA and plans to continue development of XmAb14045 pending resolution of the partial hold. - Multiple Complete Remissions Achieved: In
December 2018 , initial data from the Phase 1 study, presented at theAmerican Society of Hematology (ASH) Annual Meeting, indicated multiple complete remissions had been achieved with weekly dosing of XmAb14045 in this heavily-pretreated patient population. Cytokine release syndrome (CRS) was the most common toxicity occurring in 55% of patients. 6% of patients experienced Grade 3 or 4 CRS. CRS was more severe on the initial dose and was generally manageable with premedication. Additional adverse events consistent with CRS but not reported as such, including chills, fever, tachycardia, hypotension and hypertension within 24 hours of infusion, were reported in an additional 29% of patients. 28% of evaluable patients (n=5/18) achieved either complete remission (CR) or CR with incomplete hematologic recovery (CRi) at the two highest initial dose levels studied (1.3 and 2.3 mcg/kg weekly).
Collaboration for XmAb®24306 and Novel IL-15 Cytokines with Genentech: In
Oncology Pipeline: Xencor's bispecific Fc domains are being used to develop several classes of novel drug candidates in oncology, including: CD3 bispecific antibodies, tumor microenvironment (TME) activator bispecific antibodies and cytokines.
- CD3 Bispecific Antibodies:
Xencor's initial bispecific antibody programs are tumor-targeted antibodies that contain both a tumor antigen binding domain and a cytotoxic T-cell binding domain (CD3). These bispecific antibodies activate T cells for highly potent and targeted killing of malignant cells. InJanuary 2019 ,Xencor announced that as part of a strategic pipeline reprioritization, its partnerNovartis decided to return its rights to develop and commercialize XmAb®13676 (CD20 x CD3) and that the Company intends to continue development of XmAb13676 as planned. In addition to working toward resolution of the partial clinical hold on the Phase 1 study of XmAb14045, initial data from the Phase 1 studies of XmAb13676 in patients with B-cell malignancies and XmAb®18087 (SSTR2 x CD3) in patients with neuroendocrine tumors or gastrointestinal stromal tumors, are expected in the second half of 2019. - TME Activator Bispecific Antibodies:
Xencor's bispecific pipeline includes a suite of TME activators that engage multiple, different targets, such as T-cell checkpoint or agonist receptors. Initial data from DUET-2, a Phase 1 study of XmAb®20717 (PD-1 x CTLA-4) in patients with advanced solid tumors, are expected in the second half of 2019. Initiation of a Phase 1 study of XmAb®23104 (PD-1 xICOS ) in patients with select advanced solid tumors and initiation of a Phase 1 study of XmAb®22841 (CTLA-4 x LAG-3) in patients with select advanced solid tumors as a monotherapy and in combination with pembrolizumab are expected in the first half of 2019. - Cytokines:
Xencor uses its bispecific Fc domain and Xtend technology to engineer cytokines that have potency tuned to improve therapeutic index and have longer half-life. The Company's first cytokine candidate is XmAb24306, which is being co-developed with Genentech. IL-15 cytokines, like XmAb24306, may be promising candidates for oncology combination therapies, and under the Genentech Agreement,Xencor retained the right to perform clinical studies of collaboration products in combination with other therapeutic agents, subject to certain requirements. XmAb24306 is currently in IND-enabling studies, and the Company will support Genentech's efforts to submit an IND application for this candidate in the second half of 2019.
Obexelimab (XmAb®5871): Obexelimab is a first-in-class monoclonal antibody that targets CD19 with its variable domain and uses
Partnered XmAb Programs: Eight pharmaceutical companies and the
In
Fourth Quarter and Full Year Ended
Effective
Cash, cash equivalents and marketable securities totaled
Total revenue for the three- and twelve-month periods ended
Research and development expenditures for the fourth quarter ended
General and administrative expenses for the fourth quarter ended
Non-cash, stock-based compensation expense for the year ended
Net loss for the fourth quarter ended
The total shares outstanding were 56,279,542 as of
Financial Guidance
Based on current operating plans,
Conference Call and Webcast
The live call may be accessed by dialing (877) 359-9508 for domestic callers or (224) 357-2393 for international callers and referencing conference ID number 6482077. A live webcast of the conference call will be available online from the Investors section of the Company's website at www.xencor.com. The webcast will be archived on the company's website for 90 days.
About
Forward Looking Statements
Statements contained in this press release regarding matters that are not historical facts are forward-looking statements within the meaning of applicable securities laws, including, but not limited to, the quotations from
Xencor, Inc. |
|||||
Condensed Balance Sheets |
|||||
(in thousands) |
|||||
December 31, |
|||||
2018 |
2017 |
||||
(Revised) |
|||||
Assets |
|||||
Current assets |
|||||
Cash and cash equivalents |
$ 26,246 |
$ 16,528 |
|||
Short-term marketable securities |
268,115 |
207,603 |
|||
Accounts receivable |
10,187 |
1,142 |
|||
Income tax receivable |
804 |
— |
|||
Other current assets |
10,375 |
5,606 |
|||
Total current assets |
315,727 |
230,879 |
|||
Property and equipment, net |
11,813 |
7,088 |
|||
Intangible assets, net |
11,969 |
11,148 |
|||
Long-term marketable securities |
236,108 |
139,198 |
|||
Income tax receivable |
804 |
1,524 |
|||
Other assets |
311 |
365 |
|||
Total assets |
$ 576,732 |
$ 390,202 |
|||
Liabilities and stockholders' equity |
|||||
Current liabilities |
|||||
Accounts payable and accrued liabilities |
$ 13,459 |
$ 12,349 |
|||
Current portion of deferred revenue |
40,079 |
60,118 |
|||
Other current liabilities |
315 |
183 |
|||
Total current liabilities |
53,853 |
72,650 |
|||
Deferred rent, less current portion |
1,198 |
1,088 |
|||
Total liabilities |
55,051 |
73,738 |
|||
Stockholders' equity |
521,681 |
316,464 |
|||
Total liabilities and stockholders' equity |
$ 576,732 |
$ 390,202 |
The 2017 balance sheet was derived from the 2017 annual financial statements included in the Form 10-K that was filed on February 28, 2018. |
The 2017 balances have been revised to reflect the adoption of Accounting Standard Codification (ASC) 606. |
Xencor Inc. |
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Condensed Statements of Comprehensive Income (Loss) |
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(in thousands, except share and per share data) |
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Three months ended December 31, |
Year ended |
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(Revised) |
(Revised) |
|||||||
2018 |
2017 |
2018 |
2017 |
|||||
(unaudited) |
||||||||
Revenues |
$ 11,564 |
$ 30,150 |
$ 40,603 |
$ 46,150 |
||||
Operating expenses: |
||||||||
Research and development |
27,130 |
20,397 |
97,501 |
71,772 |
||||
General and administrative |
5,517 |
4,427 |
22,472 |
17,501 |
||||
Total operating expenses |
32,647 |
24,824 |
119,973 |
89,273 |
||||
Income (loss) from operations |
(21,083) |
5,326 |
(79,370) |
(43,123) |
||||
Other income, net |
2,884 |
954 |
8,961 |
4,174 |
||||
Income (loss) before income taxes |
(18,199) |
6,280 |
(70,409) |
(38,949) |
||||
Income tax (benefit) provision |
— |
(1,086) |
— |
(463) |
||||
Net income (loss) |
(18,199) |
7,366 |
(70,409) |
(38,486) |
||||
Other comprehensive loss |
||||||||
Net unrealized loss on marketable securities |
1,367 |
(711) |
837 |
(367) |
||||
Comprehensive income (loss) |
$ (16,832) |
$ 6,655 |
$ (69,572) |
$ (38,853) |
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Net income (loss) per share: |
||||||||
Basic net income (loss) per share |
$ (0.32) |
$ 0.16 |
$ (1.31) |
$ (0.82) |
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Fully diluted net income (loss) per share |
$ (0.32) |
$ 0.15 |
$ (1.31) |
$ (0.82) |
||||
Weighted average number of shares used in computing net income (loss), basic |
56,245,827 |
46,969,667 |
53,942,116 |
46,817,756 |
||||
Weighted average number of shares used in computing net income (loss), fully diluted |
56,245,827 |
48,200,950 |
53,942,116 |
46,817,756 |
Revenue reported for the three and twelve months ended December 31, 2017 has been revised to reflect the adoption of ASC 606 |
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SOURCE
Investor Contact: Charles Liles, Tel: 626-737-8118, cliles@xencor.com; Corporate Communications Contact: Jason I. Spark, Canale Communications for Xencor, Tel: 619-849-6005, jason@canalecomm.com