Xencor Reports Third Quarter 2018 Financial Results
"Our recent data readouts represent advancement across our pipeline of wholly owned and partnered XmAb®-based therapeutics for autoimmune disorders and cancer," said
Dr. Dahiyat added, "This is the first clinical data to emerge from our bispecific oncology programs and reflects the potential of our novel bispecific Fc domains to enable stable, long-lived bispecific antibodies in which their potencies are tuned to potentially improve tolerability and effectiveness. Our broad pipeline now includes seven bispecific candidates in addition to our lead autoimmune disease candidate, XmAb5871, which is expected to enter into a Phase 3 study in IgG4-RD by early 2019."
Recent Business Highlights and Upcoming Clinical Plans
XmAb5871: XmAb5871 is a first-in-class monoclonal antibody that targets CD19 with its variable domain and uses
- Based on promising Phase 2 results and ongoing discussions with the regulatory authorities,
Xencor is designing a randomized, placebo-controlled, double-blind Phase 3 trial of XmAb5871 in approximately 200 to 250 patients and is defining the novel endpoint in order to evaluate the addition of XmAb5871 to standard of care. Initiation of the study is expected by early 2019.
In
Bispecific Oncology Pipeline:
CD3 Bispecific Antibodies:
- Presentation of initial data from Phase 1 study of XmAb14045 (CD123 x CD3) in patients with acute myeloid leukemia (AML) on
December 3, 2018 at theAmerican Society of Hematology (ASH) Annual Meeting. - Initial data from Phase 1 study of XmAb®13676 (CD20 x CD3) in B-cell malignancies, expected in 2019, pending alignment on timing with
Novartis . - Initial data from Phase 1 study of XmAb®18087 (SSTR2 x CD3) in neuroendocrine tumors and gastrointestinal stromal tumors, expected in 2019.
TME Activator Bispecific Antibodies:
- Initial data from DUET-2, a Phase 1 study of XmAb®20717 (PD-1 x CTLA-4) in advanced solid tumors, expected in 2019.
- IND application for XmAb23104 (PD-1 x
ICOS ) allowed by theFDA inNovember 2018 ; initiation of Phase 1 study in select solid tumors expected in 2019. - IND submission for XmAb22841 (CTLA-4 x LAG-3) in multiple oncology indications, expected by year-end 2018; initiation of Phase 1 trial expected in 2019.
Bispecific Cytokines:
- IND submission for XmAb®24306 (IL15/IL15Rα-Fc) in multiple oncology indications expected in 2019.
XmAb®7195: XmAb7195 is a first-in-class monoclonal antibody that targets IgE with its variable domain and uses
Partnered XmAb Programs: Eight pharmaceutical companies and the
In the third quarter of 2018,
Third Quarter Ended
Effective
Cash, cash equivalents and marketable securities totaled
Total revenue for the three- and nine-month periods ended
Research and development expenditures for the third quarter ended
General and administrative expenses for the third quarter ended
Non-cash, stock-based compensation expense for the nine months ended
Net income for the third quarter ended
The total shares outstanding were 56,212,449 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 5577136. 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) |
|||||
September 30, |
December 31, |
||||
2018 |
2017 |
||||
(Unaudited) |
(Revised) |
||||
Assets |
|||||
Current assets |
|||||
Cash and cash equivalents |
$ 34,996 |
$ 16,528 |
|||
Short-term marketable securities |
236,605 |
207,603 |
|||
Accounts receivable |
2,462 |
1,142 |
|||
Other current assets |
12,857 |
5,606 |
|||
Total current assets |
286,920 |
230,879 |
|||
Property and equipment, net |
9,688 |
7,088 |
|||
Long-term marketable securities |
276,228 |
139,198 |
|||
Intangible assets, net |
11,677 |
11,148 |
|||
Income tax receivable |
762 |
1,524 |
|||
Other assets |
311 |
365 |
|||
Total assets |
$ 585,586 |
$ 390,202 |
|||
Liabilities and stockholders' equity |
|||||
Current liabilities |
|||||
Accounts payable and accrued liabilities |
$ 11,654 |
$ 12,349 |
|||
Deferred revenue |
40,079 |
60,118 |
|||
Other current liabilities |
294 |
183 |
|||
Total current liabilities |
52,027 |
72,650 |
|||
Deferred rent, less current portion |
1,286 |
1,088 |
|||
Total liabilities |
53,313 |
73,738 |
|||
Stockholders' equity |
532,273 |
316,464 |
|||
Total liabilities and stockholders' equity |
$ 585,586 |
$ 390,202 |
|||
The 2017 balance sheet was derived from the 2017 annual financial statements included in the Form 10-K |
Xencor Inc. |
|||||||||||||
Condensed Statements of Comprehensive Income (Loss) |
|||||||||||||
(in thousands, except share and per share data) |
|||||||||||||
Three months ended September 30, |
Nine months ended September 30, |
||||||||||||
(Revised) |
(Revised) |
||||||||||||
2018 |
2017 |
2018 |
2017 |
||||||||||
(unaudited) |
(unaudited) |
||||||||||||
Revenues |
$ |
29,039 |
$ |
- |
$ |
29,039 |
$ |
16,000 |
|||||
Operating expenses: |
|||||||||||||
Research and development |
20,953 |
19,408 |
70,371 |
51,376 |
|||||||||
General and administrative |
7,435 |
4,172 |
16,955 |
13,074 |
|||||||||
Total operating expenses |
28,388 |
23,580 |
87,326 |
64,450 |
|||||||||
Income (loss) from operations |
651 |
(23,580) |
(58,287) |
(48,450) |
|||||||||
Other income, net |
2,499 |
1,101 |
6,077 |
3,220 |
|||||||||
Income (loss) before income taxes |
3,150 |
(22,479) |
(52,210) |
(45,230) |
|||||||||
Income tax expense |
— |
173 |
— |
623 |
|||||||||
Net income (loss) |
3,150 |
(22,652) |
(52,210) |
(45,853) |
|||||||||
Other comprehensive income (loss) |
|||||||||||||
Net unrealized (loss) gain on marketable securities |
(330) |
143 |
(530) |
344 |
|||||||||
Comprehensive income (loss) |
$ |
2,820 |
$ |
(22,509) |
$ |
(52,740) |
$ |
(45,509) |
|||||
Net income (loss) per share: |
|||||||||||||
Basic net income (loss) per share |
$ |
0.06 |
$ |
(0.48) |
$ |
(0.98) |
$ |
(0.98) |
|||||
Diluted net income (loss) per share |
$ |
0.05 |
$ |
(0.48) |
$ |
(0.98) |
$ |
(0.98) |
|||||
Weighted-average number of common shares used in net income (loss) per share applicable to common stockholders, basic |
55,974,080 |
46,929,498 |
53,165,774 |
46,766,562 |
|||||||||
Weighted average number of shares used in computing net income (loss), diluted |
58,313,002 |
46,929,498 |
53,165,774 |
46,766,562 |
|||||||||
The condensed statements of comprehensive loss for the three and nine-month period ended September 30, 2017 have been revised to reflect the adoption of the new accounting standard for revenue recognition, ASC 606. |
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SOURCE
Investor Contact: John Kuch, Senior Vice President, Finance and Chief Financial Officer, Xencor, Tel: 626-737-8013, jkuch@xencor.com; Corporate Communications Contact: Jason I. Spark, Canale Communications for Xencor, Tel: 619-849-6005, jason@canalecomm.com