Xencor Reports Second Quarter 2015 Financial and Operating Results
"Currently eight XmAb® antibody candidates are in clinical testing, six with partners and two internal. The accelerating momentum of this pipeline of antibodies is a direct result of the breadth of immune biology that our proprietary XmAb platform addresses. We recently unveiled updates on our development plans for our internally-led programs XmAb®5871 in the rare autoimmune disorder IgG4-Related Disease (IgG4-RD) and XmAb®7195 for the treatment of asthma, and we also announced the selection of our second oncology bispecific antibody, XmAb®13676, which will enter clinical testing for B-cell malignancies in 2016," said
Recent Business Highlights
XmAb5871: A first-in-class monoclonal antibody that targets CD19 with its variable domain and that uses
Xencor plans to initiate an open-label, pilot study of XmAb5871 in IgG4-Related Disease (IgG4-RD) in 2015. The trial, designed to assess control of disease activity, will enroll approximately 15 subjects for up to 24 weeks and will utilize the IgG4-RD Responder Index to measure treatment activity (Carruthers 2012,International Journal of Rheumatology ).- At the European League Against Rheumatism (EULAR) 2015 Annual Meeting in
June 2015 ,Xencor reported complete data results from a Phase 1b/2a clinical trial for XmAb5871 in patients with rheumatoid arthritis (RA). XmAb5871 was generally well tolerated and showed trends in improvement in RA disease activity by multiple disease activity measures and across multiple dose groups. In the Phase 2a portion of the trial,Xencor reported that 33.3% of patients (5 of 15) who received six biweekly doses of XmAb5871 achieved DAS28-CRP remission (13.3%) or low disease activity (20%) versus zero on placebo. ACR responses were also enhanced in XmAb5871 treated patients, with 86.7%, 40.0% and 20.0% of patients achieving an ACR20, ACR50 and ACR70 response, respectively, compared to 62.5%, 12.5% and 0% for the placebo group. The trials' primary objective was characterizing safety and tolerability, and XmAb5871 was generally well tolerated, with the most common treatment-related adverse events (AEs) observed being predominately mild-to-moderate gastrointestinal toxicities (nausea, vomiting, diarrhea) occurring during the first infusion of XmAb5871. These gastrointestinal AEs did not typically recur on subsequent infusions and no infusions were discontinued due to these AEs. Treatment related serious adverse events (SAEs) occurred in two patients who received XmAb5871: infusion-related reaction and venous thrombosis. Two patients in the placebo-treated group also reported SAEs.
XmAb7195: A first in class monoclonal antibody that targets IgE with its variable domain and uses
- In
June 2015 ,Xencor announced commencement of an expansion of the Phase 1a trial of XmAb7195, in which subjects will receive two doses of XmAb7195. This new part of the trial will allowXencor to examine IgE reduction and the safety of XmAb7195 after a second infusion. Complete XmAb7195 Phase 1a study results are expected in the first half of 2016. - Also in
June 2015 ,Xencor announced that a Phase 1 trial with a subcutaneous formulation of XmAb7195 is planned for 2016.
Bispecific Oncology Pipeline:
- XmAb®14045 (CD123xCD3 bispecific antibody):
Xencor plans to initiate clinical trials of XmAb14045 targeting CD123, a target on tumor cells in acute myeloid leukemia, and CD3 in 2016. - XmAb®13676 (CD20xCD3 bispecific antibody): In
June 2015 ,Xencor announced the selection of XmAb13676, its second bispecific oncology candidate for development. XmAb®13676 targets CD20 on malignant B cells and CD3. The Company expects XmAb13676 to begin clinical trials for B-cell malignancies in 2016.
Corporate
- In
May 2015 ,Xencor announced the appointment ofMark Lotz , R.Ph. as vice president of regulatory affairs andWayne Saville , M.D., as vice president of clinical oncology. Previously,Mr. Lotz served as a regulatory and quality consultant and as a representative to regulatory agencies, and he has more than 35 years of biotechnology and pharmaceutical experience in regulatory affairs.Dr. Saville joinsXencor fromTocagen Inc. , where he served as vice president of clinical development oncology, and has more than 25 years of clinical affairs and medical research experience. - In
July 2015 ,Xencor announced the appointment ofYujiro S. Hata to its board of directors.Mr. Hata joins the board with more than 20 years of industry-related experience. Currently,Mr. Hata serves as chief operating officer at immunooncology company FLX Bio where he oversees all business operations, mergers and acquisitions, and licensing.
Second Quarter and Six Months Ended
Cash equivalents and marketable securities totaled $159.2 million as of June 30, 2015, compared to
Revenues for the second quarter ended
Research and development expenditures for the second quarter ended
General and administrative expenses in the second quarter ended
Non-cash, share-based compensation expense for the first six months of 2015 was
Net loss for the second quarter ended June 30, 2015 was $8.9 million, or $(0.22) on a fully diluted per share basis, compared to a net loss of $5.0 million, or $(0.16) on a fully diluted per share basis, for the same period in 2014. For the six months ended
The total shares outstanding as of
Financial Guidance
Based on current operating plans, Xencor expects to have sufficient cash to fund research and development programs and operations through 2019.
Conference Call and Webcast
The live call may be accessed by dialing (855) 433-0932 for domestic callers or (484) 756-4280 for international callers, and referencing conference ID number: 83620680. A live webcast of the conference call will be available online from the investor relations section of the company website at www.xencor.com. The webcast will be archived on the company website for 30 days.
About Xencor, Inc.
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 the quotation from
Investor Contact:
Tel: 626-737-8013
jkuch@xencor.com
Corporate Communications Contact:
Tel: 619-849-6005
jason@canalecomm.com
Xencor, Inc. | |||||
Condensed Balance Sheets | |||||
(in thousands) | |||||
|
| ||||
2015 |
2014 | ||||
(Unaudited) |
|||||
Assets |
|||||
Current assets |
|||||
Cash and cash equivalents |
$ 11,171 |
$ 54,649 | |||
Short term marketable securities |
56,714 |
— | |||
Other current assets |
1,835 |
3,100 | |||
Total current assets |
69,720 |
57,749 | |||
Property and equipment, net |
1,804 |
899 | |||
Long-term marketable securities |
91,284 |
— | |||
Intangible assets, net |
9,691 |
9,116 | |||
Other assets |
64 |
59 | |||
Total assets |
$ 172,563 |
$ 67,823 | |||
Liabilities and stockholders' equity |
|||||
Current liabilities |
|||||
Accounts payable and accrued liabilities |
$ 5,614 |
$ 3,942 | |||
Current portion of deferred revenue |
2,794 |
2,254 | |||
Total current liabilities |
8,408 |
6,196 | |||
Deferred rent, less current portion |
703 |
— | |||
Deferred revenue, less current portion |
1,384 |
2,337 | |||
Total liabilities |
10,495 |
8,533 | |||
Stockholders' equity |
162,068 |
59,290 | |||
Total liabilities and stockholders' equity |
$ 172,563 |
$ 67,823 | |||
The 2014 balance sheet was derived from the 2014 annual financial statements included in the form 10-K that was filed on |
Condensed Statements of Comprehensive Loss (in thousands, except share and per share data) | |||||||||
Three months ended |
Six months ended | ||||||||
2015 |
2014 |
2015 |
2014 | ||||||
(Unaudited) |
(Unaudited) |
(Unaudited) |
(Unaudited) | ||||||
Revenues |
$ 1,014 |
$ 824 |
$ 2,505 |
$ 3,008 | |||||
Operating expenses: |
|||||||||
Research and development |
7,476 |
4,283 |
12,681 |
8,511 | |||||
General and administrative |
2,524 |
1,594 |
5,288 |
3,317 | |||||
Total operating expenses |
10,000 |
5,877 |
17,969 |
11,828 | |||||
Loss from operations |
(8,986) |
(5,053) |
(15,464) |
(8,820) | |||||
Other income (expense), net |
118 |
9 |
152 |
25 | |||||
Net loss |
(8,868) |
(5,044) |
(15,312) |
(8,795) | |||||
Net unrealized loss on marketable securities |
(55) |
— |
(90) |
— | |||||
Comprehensive loss |
$ (8,923) |
$ (5,044) |
$ (15,402) |
$ (8,795) | |||||
Basic and diluted net loss per common share |
$ (0.22) |
$ (0.16) |
$ (0.41) |
$ (0.28) | |||||
Basic and diluted weighted average number of common shares |
40,389,648 |
31,372,618 |
37,518,271 |
31,366,781 |
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