Xencor Reports Second Quarter 2023 Financial Results
-- Management to Host Conference Call at
“In the past quarter we continued to advance a clinical portfolio of XmAb drug candidates, enrolling patients across multiple Phase 1 and Phase 2 studies in oncology and autoimmune diseases. By year end we anticipate opening a Phase 2 study to evaluate vudalimab as a front-line treatment in metastatic non-small cell lung cancer, a large patient population with high unmet need,” said
“We also continue to expand the portfolio of XmAb programs. We recently initiated a Phase 1 study of our potency-tuned IL12-Fc, XmAb662, to be developed in oncology, and we expect to submit an IND application later this year for XmAb541, a 2+1 format CLDN6 x CD3 bispecific antibody that we are developing for patients with ovarian cancer and other tumor types. Additionally, we anticipate submitting an IND for our second internal CD28 program in 2024.”
Program Updates
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Vudalimab (PD-1 x CTLA-4):
Xencor plans to evaluate vudalimab, a T-cell selective checkpoint inhibitor, as a first-line treatment in patients with locally advanced or metastatic non-small cell lung cancer. Part 1 of a Phase 2 study would randomize a limited number of patients at one of two doses of vudalimab, in combination with chemotherapy. The study’s second part would randomize patients to either vudalimab plus chemotherapy or pembrolizumab plus chemotherapy. The primary outcome measure of Part 2 would be a comparison of progression-free survival.Xencor anticipates initiating the study by the end of 2023.
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XmAb564 (IL2-Fc): Results from a Phase 1a clinical study in healthy volunteers were presented at the
European Congress of Rheumatology (EULAR) inMay 2023 . Data continue to indicate a single dose of subcutaneously administered XmAb564 was well tolerated and generated durable, dose-dependent and selective expansion of regulatory T cells.Xencor is conducting a randomized, double-blind, placebo-controlled Phase 1b study to evaluate the safety and tolerability of multiple ascending doses of XmAb564 in patients with atopic dermatitis or psoriasis.
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XmAb662 (IL12-Fc): XmAb662 is a potency-reduced interleukin-12 Fc (IL12-Fc) fusion protein engineered to increase anti-tumor activity and immunogenicity in the tumor microenvironment by promoting high levels of interferon gamma secretion from T cells and NK cells. In
July 2023 ,Xencor initiated a Phase 1 study in patients with advanced solid tumors.
Partnership Updates
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Alexion Pharmaceuticals, Inc. : InMay 2023 , Ultomiris® (ravulizumab-cwvz), which incorporates Xencor’s Xtend™ Fc domain, was approved in the EU andJapan for the treatment of certain adult patients with neuromyelitis optica spectrum disorder (NMOSD). In the second quarter of 2023,Xencor earned$11.2 million of royalty revenue from Alexion on net sales of Ultomiris.
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Amgen Inc.: Interim results from a Phase 1 study of xaluritamig (AMG 509), a STEAP1 x CD3 XmAb 2+1 bispecific antibody, in patients with mCRPC were accepted for presentation at the
European Society for Medical Oncology (ESMO) Congress onOctober 20, 2023 .
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Zenas BioPharma Ltd. : In the second quarter of 2023,Xencor earned a$10 million development milestone related to Zenas’ Phase 3 study evaluating obexelimab in patients with immunoglobulin G4-related disease (IgG4-RD). A manuscript with results from the Phase 2 study, which was sponsored and conducted byXencor , was first published online in The Lancet Rheumatology inAugust 2023 .
Ultomiris is a registered trademark of
Financial Results for the Second Quarter and Six Months Ended
Cash, cash equivalents, receivables and marketable debt securities totaled
Total revenue for the second quarter ended
Research and development (R&D) expenses for the second quarter ended
General and administrative (G&A) expenses for the second quarter ended
Other income (expense) for the second quarter ended
Non-cash, stock-based compensation expense for the six months ended
Net loss for the second quarter ended
The total shares outstanding were 60,600,060 as of
Financial Guidance
Based on current operating plans,
Conference Call and Webcast
The live webcast may be accessed through “Events & Presentations” in the Investors section of the Company’s website, located at investors.xencor.com. Telephone participants may register to receive a dial-in number and unique passcode that can be used to access the call. A recording will be available for at least 30 days.
About
Forward-Looking Statements
Certain statements contained in this press release may constitute forward-looking statements within the meaning of applicable securities laws. Forward-looking statements include statements that are not purely statements of historical fact, and can generally be identified by the use of words such as “potential,” “can,” “will,” “plan,” “may,” “could,” “would,” “expect,” “anticipate,” “seek,” “look forward,” “believe,” “committed,” “investigational,” and similar terms, or by express or implied discussions relating to Xencor’s business, including, but not limited to, statements regarding planned additional clinical trials, the quotations from
Condensed Balance Sheets | ||||||||
(in thousands) | ||||||||
|
2023 |
|
2022 |
|||||
(unaudited) | ||||||||
Assets | ||||||||
Current assets | ||||||||
Cash and cash equivalents |
$ |
34,710 |
$ |
53,942 |
||||
Marketable debt securities |
|
476,667 |
|
526,689 |
||||
Marketable equity securities |
|
39,995 |
|
42,431 |
||||
Accounts receivable |
|
20,019 |
|
28,997 |
||||
Prepaid expenses |
|
22,171 |
|
23,283 |
||||
Total current assets |
|
593,562 |
|
675,342 |
||||
Property and equipment, net |
|
67,997 |
|
59,183 |
||||
Intangible assets, net |
|
18,708 |
|
18,500 |
||||
Marketable debt securities - long term |
|
— |
|
3,826 |
||||
Marketable equity securities - long term |
|
64,210 |
|
54,383 |
||||
Right of use asset |
|
33,046 |
|
34,419 |
||||
Other assets |
|
598 |
|
613 |
||||
Total assets |
$ |
778,121 |
$ |
846,266 |
||||
Liabilities and stockholders’ equity | ||||||||
Current liabilities | ||||||||
Accounts payable and accrued liabilities |
$ |
32,537 |
$ |
28,816 |
||||
Deferred revenue |
|
7,865 |
|
30,320 |
||||
Lease liabilities |
|
4,228 |
|
4,708 |
||||
Total current liabilities |
|
44,630 |
|
63,844 |
||||
Lease liabilities, net of current portion |
|
54,615 |
|
54,926 |
||||
Total liabilities |
|
99,245 |
|
118,770 |
||||
Stockholders’ equity |
|
678,876 |
|
727,496 |
||||
Total liabilities and stockholders’ equity |
$ |
778,121 |
$ |
846,266 |
||||
The 2022 balance sheet was derived from the 2022 annual financial statements included in the Form 10-K that was filed on |
Condensed Statements of Comprehensive Income (Loss) | |||||||||||||||||
(in thousands, except share and per share data) | |||||||||||||||||
Three months ended |
Six months ended |
||||||||||||||||
2023 |
|
2022 |
|
2023 |
|
2022 |
|
||||||||||
(unaudited) | |||||||||||||||||
Revenues | $ |
45,523 |
|
$ |
30,175 |
|
$ |
64,485 |
|
$ |
115,670 |
|
|||||
Operating expenses: | |||||||||||||||||
Research and development |
60,060 |
|
47,084 |
|
124,439 |
|
94,839 |
|
|||||||||
General and administrative |
11,460 |
|
11,091 |
|
25,408 |
|
22,364 |
|
|||||||||
Total operating expenses |
71,520 |
|
58,175 |
|
149,847 |
|
117,203 |
|
|||||||||
Loss from operations |
(25,997 |
) |
(28,000 |
) |
(85,362 |
) |
(1,533 |
) |
|||||||||
Other income (expense), net |
4,043 |
|
(5,975 |
) |
2,645 |
|
(8,847 |
) |
|||||||||
Net loss |
(21,954 |
) |
(33,975 |
) |
(82,717 |
) |
(10,380 |
) |
|||||||||
Other comprehensive gain (loss) | |||||||||||||||||
Net unrealized gain (loss) on marketable debt securities |
1,765 |
|
(1,823 |
) |
5,093 |
|
(7,435 |
) |
|||||||||
Comprehensive loss | $ |
(20,189 |
) |
$ |
(35,798 |
) |
$ |
(77,624 |
) |
$ |
(17,815 |
) |
|||||
Net loss per share: | |||||||||||||||||
Basic and diluted net loss per share | $ |
(0.37 |
) |
$ |
(0.57 |
) |
$ |
(1.38 |
) |
$ |
(0.17 |
) |
|||||
Weighted-average number of common shares used in net loss per share applicable to common stockholders - basic and diluted |
59,807,558 |
|
59,567,139 |
|
59,922,784 |
|
59,487,924 |
|
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For Investors:
cliles@xencor.com
(626) 737-8118
For Media:
Evoke Canale
jason.spark@evokegroup.com
(619) 849-6005
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