Xencor Reports Third Quarter 2023 Financial Results
- Xencor received a substantial $215 million upfront payment from OMERS Life Sciences through a royalty transaction, strengthening the company's balance sheet and extending its cash runway into 2027. The company also reported a total revenue of $59.2 million for Q3 2023, primarily from milestone revenue and royalty revenue. Additionally, Xencor provided a detailed update on its pipeline decisions and clinical programs, indicating a strategic focus on targeted T cell-engaging bispecifics for the treatment of patients with solid tumors.
- None.
-- Royalty Transaction Generates
-- Management to Host Conference Call at 4:30 p.m. ET Today --
“Today we are announcing measures to strengthen our balance sheet and maximize our focus on the most promising programs created with XmAb® technologies. First, we have sold a portion of our Ultomiris® and Monjuvi® royalties to OMERS Life Sciences for an upfront payment of
“These pipeline decisions highlight an enhanced focus on targeted T cell-engaging bispecifics, which hold great potential for the treatment of patients with solid tumors, as recently shown at the ESMO conference by our partner Amgen. Our ENPP3 x CD3 and B7-H3 x CD28 bispecifics lead our internal clinical pipeline for this modality, and we expect to add our CLDN6 x CD3 program in 2024.”
Xencor Receives
Xencor has sold portions of financial interests from Alexion Pharmaceuticals, Inc., on sales of Ultomiris® (ravulizumab-cwvz) and from MorphoSys AG on sales of Monjuvi® (
Under the agreements, Xencor has received a
Pipeline Updates
-
Vudalimab (PD-1 x CTLA-4): As previously disclosed, Xencor anticipates initiating a Phase 1b/2 study to evaluate vudalimab, a T-cell selective checkpoint inhibitor, in combination with chemotherapy, as a first-line treatment in patients with advanced non-small cell lung cancer, by the end of 2023. Part 1 of the study will evaluate the safety and preliminary activity of two dose levels of vudalimab, enrolling up to 20 patients in each dose group, in order to recommend a dose level for Part 2 of the study.
Xencor has been evaluating vudalimab in ongoing studies, as a monotherapy in patients with high-risk metastatic castration-resistant prostate cancer (mCRPC) and in gynecologic tumors, and in combination with chemotherapy or a PARP inhibitor in patients with mCRPC. Due to the rapidly changing competitive environment in these indications, the Company has closed the gynecologic tumor cohorts in the monotherapy study. Prostate cancer clinical data are anticipated to be presented at a medical conference in early 2024.
- XmAb104 (PD-1 x ICOS): Xencor will stop internal development of XmAb104 due to emerging data from Phase 1 expansion cohorts not meeting efficacy criteria for advancing the program. The study expansion enrolled patients with microsatellite stable colorectal cancer with or without liver metastases. The Company will continue to support patients currently enrolled and being treated.
- Efbalropendekin alfa (XmAb306, IL15/IL15Rα-Fc Cytokine): Xencor exercised its right under the Genentech agreement to convert its co-development and sharing of profits and losses on efbalropendekin alfa into a milestone and royalty arrangement without cost-sharing. The Company expects to finalize contract changes before year end.
- XmAb541 (CLDN6 x CD3): XmAb541 is a bispecific antibody that targets Claudin-6 (CLDN6), a tumor-associated antigen in ovarian cancer and other solid tumor types, and the CD3 receptor on T cells. The XmAb 2+1 multivalent format used in XmAb541 enables greater selectivity for CLDN6 over similar Claudin family members, such as CLDN9, CLDN3 and CLDN4. Xencor plans to submit an investigational new drug (IND) application by year end.
Progress Across Partnerships
- Amgen Inc.: Encouraging interim results from a Phase 1 study of xaluritamig, a STEAP1 x CD3 XmAb 2+1 bispecific antibody, were presented at the European Society for Medical Oncology (ESMO) Congress in October 2023.
-
Janssen Biotech, Inc.: Xencor received
$15 million
-
Gilead Sciences, Inc.: Xencor received a
$6 million
-
Omeros Corporation: Xencor received a
$5 million
Additional Corporate Updates
- In September, Xencor appointed Barbara J. Klencke, M.D., to its board of directors. Dr. Klencke is a world-class, patient-focused research and development expert, who has a successful track record in development and early commercialization of several medicines approved for the treatment of patients with cancer. She most recently served as chief medical officer and chief development officer at Sierra Oncology through mid-2023.
- John Kuch, senior vice president and chief financial officer, plans to retire in March 2024, after a successful 23-year career with Xencor. The Company is initiating a search for a new chief financial officer.
Monjuvi® and Minjuvi® are registered trademarks of MorphoSys AG. Ultomiris® is a registered trademark of Alexion Pharmaceuticals, Inc.
Financial Results for the Third Quarter and Nine Months Ended September 30, 2023
Cash, cash equivalents, receivables and marketable debt securities totaled
Total revenue for the third quarter ended September 30, 2023 was
Research and development (R&D) expenses for the third quarter ended September 30, 2023 were
General and administrative (G&A) expenses for the third quarter ended September 30, 2023 were
Other income (expense) for the third quarter ended September 30, 2023 was
Non-cash, stock-based compensation expense for the nine months ended September 30, 2023 was
Net loss for the third quarter ended September 30, 2023 was
The total shares outstanding were 60,665,900 as of September 30, 2023, compared to 59,773,337 as of September 30, 2022.
Financial Guidance
Based on current operating plans and considering the net proceeds from the royalty sale transactions, Xencor expects to have cash to fund research and development programs and operations into 2027. The Company expects to end 2023 with between
Conference Call and Webcast
Xencor will host a conference call and webcast today at 4:30 p.m. ET (1:30 p.m. PT) to discuss the third quarter 2023 financial results and provide a corporate update.
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 Xencor, Inc.
Xencor is a clinical-stage biopharmaceutical company developing engineered antibodies and cytokines for the treatment of patients with cancer and autoimmune diseases. More than 20 candidates engineered with Xencor's XmAb® technology are in clinical development, and three XmAb medicines are marketed by partners. Xencor's XmAb engineering technology enables small changes to a protein's structure that result in new mechanisms of therapeutic action. For more information, please visit www.xencor.com.
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 clinical trials, the quotations from Xencor's president and chief executive officer, contract negotiations, planned regulatory submissions, projected amounts of cash, cash equivalents and marketable debt securities and other statements that are not purely statements of historical fact. Such statements are made on the basis of the current beliefs, expectations, and assumptions of the management of Xencor and are subject to significant known and unknown risks, uncertainties and other factors that may cause actual results, performance or achievements and the timing of events to be materially different from those implied by such statements, and therefore these statements should not be read as guarantees of future performance or results. Such risks include, without limitation, the risks associated with the process of discovering, developing, manufacturing and commercializing drugs that are safe and effective for use as human therapeutics and other risks, including the ability of publicly disclosed preliminary clinical trial data to support continued clinical development and regulatory approval for specific treatments, in each case as described in Xencor's public securities filings. For a discussion of these and other factors, please refer to Xencor's annual report on Form 10-K for the year ended December 31, 2022 as well as Xencor's subsequent filings with the Securities and Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. This caution is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, as amended to date. All forward-looking statements are qualified in their entirety by this cautionary statement and Xencor undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof, except as required by law.
| Xencor, Inc. | ||||||||
| Condensed Balance Sheets | ||||||||
| (in thousands) | ||||||||
| September 30, | December 31, | |||||||
|
2023 |
|
|
2022 |
|
|||
| (unaudited) | ||||||||
| Assets | ||||||||
| Current assets | ||||||||
| Cash and cash equivalents | $ |
52,733 |
$ |
53,942 |
||||
| Marketable debt securities |
|
412,827 |
|
|
526,689 |
|
||
| Marketable equity securities |
|
28,972 |
|
|
42,431 |
|
||
| Accounts receivable |
|
55,000 |
|
|
28,997 |
|
||
| Prepaid expenses and other current assets |
|
21,644 |
|
|
23,283 |
|
||
| Total current assets |
|
571,176 |
|
|
675,342 |
|
||
| Property and equipment, net |
|
68,035 |
|
|
59,183 |
|
||
| Intangible assets, net |
|
18,744 |
|
|
18,500 |
|
||
| Restricted cash |
|
378 |
|
|
- |
|
||
| Marketable debt securities - long term |
|
20,420 |
|
|
3,826 |
|
||
| Marketable equity securities - long term |
|
64,210 |
|
|
54,383 |
|
||
| Right of use asset |
|
34,807 |
|
|
34,419 |
|
||
| Other assets |
|
660 |
|
|
613 |
|
||
| Total assets | $ |
778,430 |
|
$ |
846,266 |
|
||
| Liabilities and stockholders’ equity | ||||||||
| Current liabilities | ||||||||
| Accounts payable and accrued liabilities | $ |
39,439 |
|
$ |
28,816 |
|
||
| Deferred revenue |
|
9,222 |
|
|
30,320 |
|
||
| Lease liabilities |
|
4,380 |
|
|
4,708 |
|
||
| Total current liabilities |
|
53,041 |
|
|
63,844 |
|
||
| Lease liabilities, net of current portion |
|
56,379 |
|
|
54,926 |
|
||
| Total liabilities |
|
109,420 |
|
|
118,770 |
|
||
| Stockholders’ equity |
|
669,010 |
|
|
727,496 |
|
||
| Total liabilities and stockholders’ equity | $ |
778,430 |
|
$ |
846,266 |
|
||
| The 2022 balance sheet was derived from the 2022 annual financial statements included in the Form 10-K that was filed on February 24, 2023 | ||||||||
| 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, |
|||||||||||||||
2023 |
2022 |
2023 |
2022 |
|||||||||||||
(unaudited) |
||||||||||||||||
| Revenues | $ |
59,164 |
|
|
$ |
27,299 |
|
|
$ |
123,649 |
|
|
$ |
142,969 |
|
|
|
|
|
|
|
|
|
||||||||||
| Operating expenses: |
|
|
|
|
|
|
|
|||||||||
| Research and development |
|
64,939 |
|
|
|
53,273 |
|
|
|
189,378 |
|
|
|
148,111 |
|
|
| General and administrative |
|
12,493 |
|
|
|
12,374 |
|
|
|
37,901 |
|
|
|
34,738 |
|
|
| Total operating expenses |
|
77,432 |
|
|
|
65,647 |
|
|
|
227,279 |
|
|
|
182,849 |
|
|
|
|
|
|
|
|
|
||||||||||
| Loss from operations |
|
(18,268 |
) |
|
|
(38,348 |
) |
|
|
(103,630 |
) |
|
|
(39,880 |
) |
|
|
|
|
|
|
|
|
||||||||||
| Other income (expense), net |
|
(6,000 |
) |
|
|
6,677 |
|
|
|
(3,357 |
) |
|
|
(2,171 |
) |
|
| Loss before income taxes |
|
(24,268 |
) |
|
|
(31,671 |
) |
|
|
(106,987 |
) |
|
|
(42,051 |
) |
|
|
|
|
|
|
|
|
||||||||||
| Income tax expense |
|
— |
|
|
|
1,088 |
|
|
|
— |
|
|
|
1,088 |
|
|
|
|
|
|
|
|
|
||||||||||
| Net loss |
|
(24,268 |
) |
|
|
(32,759 |
) |
|
|
(106,987 |
) |
|
|
(43,139 |
) |
|
|
|
|
|
|
|
|
||||||||||
| Other comprehensive gain (loss) |
|
|
|
|
|
|
|
|||||||||
| Net unrealized gain (loss) on marketable debt securities |
|
1,151 |
|
|
|
(931 |
) |
|
|
6,244 |
|
|
|
(8,366 |
) |
|
| Comprehensive loss | $ |
(23,117 |
) |
|
$ |
(33,690 |
) |
|
$ |
(100,743 |
) |
|
$ |
(51,505 |
) |
|
|
|
|
|
|
|
|
||||||||||
|
|
|
|
|
|
|
||||||||||
| Net loss per share: |
|
|
|
|
|
|
|
|||||||||
| Basic and diluted net loss per share | $ |
(0.40 |
) |
|
$ |
(0.55 |
) |
|
$ |
(1.77 |
) |
|
$ |
(0.72 |
) |
|
| Weighted-average number of common shares used in net loss per share applicable to common stockholders - basic and diluted |
|
60,621,534 |
|
|
|
59,716,594 |
|
|
|
60,387,163 |
|
|
|
59,564,985 |
|
|
View source version on businesswire.com: https://www.businesswire.com/news/home/20231107137484/en/
For Investors:
Charles Liles
cliles@xencor.com
(626) 737-8118
For Media:
Jason I. Spark
Evoke Canale
jason.spark@evokegroup.com
(619) 849-6005
Source: Xencor, Inc.
FAQ
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What is the company's cash position following the royalty transaction?
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When did Xencor host its conference call to discuss the Q3 2023 financial results?
