Xencor Reports First Quarter 2024 Financial Results
Xencor, a clinical-stage biopharmaceutical company, reported financial results for the first quarter ended March 31, 2024, focusing on bispecific T cell engagers for cancer treatment. Recent highlights include the advancement of multiple oncology programs, FDA approval of Ultomiris, and positive results in malaria prevention. The company appointed a new CFO and provided financial guidance with a cash balance of $646.7 million as of March 31, 2024. Despite a decrease in revenues and an increased net loss compared to the previous year, Xencor remains well-funded.
Xencor is focusing on developing bispecific T cell engagers for treating cancer, with positive advancements in solid tumors such as clear cell renal cell carcinoma, prostate cancer, and ovarian cancer.
The company's Xtend™ antibody half-life extension technology has supported improved outcomes for patients, with Ultomiris approved for certain patients with NMOSD in the US, Japan, and the EU.
A single dose of an investigational antibody with Xtend was up to 77% effective in preventing malaria, demonstrating the technology's potential in infectious disease prevention.
Xencor appointed a new Chief Financial Officer, Bart Cornelissen, and provided financial guidance with a cash balance expected to sustain research and development programs into 2027.
Revenues for the first quarter of 2024 decreased to $12.8 million, compared to $19.0 million for the same period in 2023, primarily due to changes in revenue sources.
Research and development expenses for the first quarter ended March 31, 2024, were $56.9 million, reflecting decreased spending compared to the same period in 2023, impacting the company's financial performance.
Net loss for the first quarter of 2024 increased to $68.0 million, or $(1.11) on a fully diluted per share basis, compared to $60.8 million for the same period in 2023, indicating a negative financial trend.
Insights
Reviewing the financial position detailed in the latest report, the decline in cash and equivalents from
The reduction in R&D expenses, from
From a development perspective, the progression into Phase 1 clinical studies of XmAb819, XmAb808 and XmAb541 is a significant step forward. The impact of these studies on the stock will depend on their outcomes, which could serve as critical catalysts for the company's valuation. The entry of XmAb541 into Phase 1 trials is particularly noteworthy as it suggests a therapeutic advancement for CLDN6-positive tumors. The approval of Ultomiris in the U.S. for NMOSD patients, which uses Xencor's Xtend technology, further solidifies the company's scientific credibility and could lead to future royalties.
The report of a single dose of an investigational antibody preventing malaria in a Phase 2 trial is an example of the potential broader applicability of the Xtend technology. While not directly impacting current financials, such findings could contribute to long-term value creation if these applications are further validated and commercialized.
Xencor's strategic focus on CD3 and CD28 T cell engagers represents alignment with current trends in immunotherapy for oncology, which could be attractive to investors looking for companies at the forefront of cancer treatment. Their multivalent antibody formatting could offer competitive advantages in terms of selectivity and safety profiles. The market for treatments in oncology is large and positive clinical trial outcomes could enable Xencor to capture significant market share.
On the business side, appointment of a new CFO usually signifies a potential shift in financial strategy, which investors should monitor for changes that could impact financial health and investor return. Overall, the company's financial guidance appears prudent given the typical volatility and long timelines associated with biopharmaceutical development.
“We have focused our XmAb® clinical pipeline and discovery activities on bispecific CD3 and CD28 T cell engagers, which continue to show clinical validation for their potential in treating patients with serious diseases. Our key clinical-stage oncology programs in solid tumors include XmAb819 (ENPP3 x CD3) in clear cell renal cell carcinoma, XmAb808 (B7-H3 x CD28) in prostate cancer and other cancers, and XmAb541 (CLDN6 x CD3) in ovarian cancer and other cancers, which are all now advancing in Phase 1 clinical studies. We plan to select our next T cell engager IND candidate later this year,” said Bassil Dahiyat, Ph.D., president and chief executive officer at Xencor. “Additionally, Xencor’s best-in-class Xtend™ antibody half-life extension technology continues to support improved outcomes for patients, with Ultomiris® now approved in the
Recent Clinical and Business Highlights
- First Patient Dosed in Phase 1 Study of XmAb®541 (CLDN6 x CD3): XmAb541 is a bispecific antibody being developed for patients with CLDN6-positive tumors including advanced ovarian cancer. XmAb541 is designed to engage the immune system, activating T cells for highly potent and targeted killing of tumor cells expressing Claudin-6 (CLDN6), a tumor-associated antigen. Xencor’s XmAb® 2+1 multivalent format used in XmAb541 enables greater selectivity for cells expressing CLDN6 over similarly structured Claudin family members, which may be expressed on normal tissue. The first patient was recently dosed in a Phase 1 dose-escalation study.
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FDA Approves Ultomiris® (Alexion Pharmaceuticals, Inc.) for Adults with NMOSD: In March 2024, Ultomiris® (ravulizumab-cwvz), which incorporates Xencor’s Xtend™ Fc Domain, was approved in
the United States as the first and only long-acting C5 complement inhibitor for the treatment of adult patients with anti-aquaporin-4 (AQP4) antibody-positive (Ab+) neuromyelitis optica spectrum disorder (NMOSD). Ultomiris is also approved for certain adults with NMOSD inJapan and the European Union (EU). As part of Xencor’s recent Ultomiris royalty monetization, the Company remains eligible for certain future royalties and milestone payments. Ultomiris is a registered trademark of Alexion Pharmaceuticals, Inc.
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Single Dose of Investigational Antibody with Xtend™ Confers Protection Against Malaria Infection: Results from a Phase 2 National Institutes of Health (NIH)-sponsored clinical trial published in the New England Journal of Medicine showed that a single dose of L9LS, an experimental monoclonal antibody that incorporates Xencor’s Xtend™ Fc Domain, was up to
77% effective in preventing malaria in children inMali for six months, demonstrating the long duration of action that Xtend technology can provide.
- New Chief Financial Officer Appointed: Bart Cornelissen was appointed as Xencor’s senior vice president and chief financial officer. He was most recently vice president, corporate finance at Seagen Inc.
Financial Guidance: Based on current operating plans, Xencor expects to end 2024 with between
Financial Results for the First Quarter Ended March 31, 2024
Cash, cash equivalents and marketable debt securities totaled
Revenues for the first quarter ended March 31, 2024 were
Research and development expenses for the first quarter ended March 31, 2024 were
General and administrative expenses for the first quarter ended March 31, 2024 were
Other expense, net, for the first quarter ended March 31, 2024 was
Non-cash, stock-based compensation expense for the first quarter ended March 31, 2024 was
Net loss for the first quarter ended March 31, 2024 was
The total shares outstanding were 61,634,685 as of March 31, 2024, compared to 60,381,600 as of March 31, 2023.
Upcoming Investor Conferences
Company management will participate at multiple upcoming investor conferences:
-
RBC Capital Markets Global Healthcare Conference
Date: Tuesday, May 14, 2024
Presentation Time: 2:05 p.m. ET / 11:05 a.m. PT
Location:New York City
-
BofA Securities Health Care Conference
Date: Wednesday, May 15, 2024
Presentation Time: 4:40 p.m. ET / 1:40 p.m. PT
Location:Las Vegas
Live webcasts of the presentations will be available under “Events & Presentations” in the Investors section of the Company’s website located at www.xencor.com. Replays of the events will be available on the Xencor website for at least 30 days following the presentations.
About Xencor
Xencor is a clinical-stage biopharmaceutical company developing engineered antibodies for the treatment of patients with cancer and other serious 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 proteins 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 presentations of clinical data, planned clinical trials, projected financial resources, the quotations from Xencor's president and chief executive officer, 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, 2023 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. | |||||||
| Selected Consolidated Balance Sheet Data | |||||||
| (in thousands) | |||||||
March 31, |
|
December 31, |
|||||
|
2024 |
|
|
|
2023 |
|
|
| (Unaudited) | |||||||
| Cash, cash equivalents and marketable debt securities - current | $ |
491,401 |
$ |
551,515 |
|||
| Other current assets |
|
70,851 |
|
|
71,645 |
|
|
| Marketable debt securities - long term |
|
155,342 |
|
|
145,892 |
|
|
| Other long term assets |
|
166,661 |
|
|
183,640 |
|
|
| Total assets | $ |
884,255 |
|
$ |
952,692 |
|
|
| Total current liabilities |
|
79,402 |
|
|
84,709 |
|
|
| Deferred income - long term |
|
113,367 |
|
|
125,183 |
|
|
| Other long term liabilities |
|
79,299 |
|
|
73,667 |
|
|
| Total liabilities |
|
272,068 |
|
|
283,559 |
|
|
| Total stockholders' equity |
|
612,187 |
|
|
669,133 |
|
|
| Total liabilities and stockholders’ equity | $ |
884,255 |
|
$ |
952,692 |
|
|
| Xencor, Inc. | |||||||
| Consolidated Statements of Loss and Comprehensive Loss | |||||||
| (in thousands, except share and per share data) | |||||||
Three months Ended March 31, |
|||||||
|
2024 |
|
|
|
2023 |
|
|
| (Unaudited) | |||||||
| Revenue | $ |
12,805 |
|
$ |
18,962 |
|
|
| Operating expenses | |||||||
| Research and development |
|
56,873 |
|
|
65,552 |
|
|
| General and administrative |
|
13,787 |
|
|
14,154 |
|
|
| Total operating expenses |
|
70,660 |
|
|
79,706 |
|
|
| Loss from operations |
|
(57,855 |
) |
|
(60,744 |
) |
|
| Other income (expense), net |
|
(10,854 |
) |
|
(19 |
) |
|
| Loss before income tax |
|
(68,709 |
) |
|
(60,763 |
) |
|
| Income tax expense |
|
— |
|
|
— |
|
|
| Net loss |
|
(68,709 |
) |
|
(60,763 |
) |
|
| Net loss attributable to non-controlling interest |
|
(676 |
) |
|
— |
|
|
| Net loss attributable to Xencor, Inc. |
|
(68,033 |
) |
|
(60,763 |
) |
|
| Other comprehensive income (loss): | |||||||
| Net unrealized gain (loss) on marketable debt securities available-for-sale |
|
(1,445 |
) |
|
3,327 |
|
|
| Comprehensive loss attributable to Xencor, Inc. | $ |
(69,478 |
) |
$ |
(57,436 |
) |
|
| Net loss per common share attributable to Xencor, Inc.: | |||||||
| Basic and Diluted | $ |
(1.11 |
) |
$ |
(1.02 |
) |
|
| Weighted average common shares used to compute net loss per share attributable to Xencor, Inc. | |||||||
| Basic and Diluted |
|
61,212,324 |
|
|
59,771,674 |
|
|
View source version on businesswire.com: https://www.businesswire.com/news/home/20240507540009/en/
For Investors:
Charles Liles
cliles@xencor.com
(626) 737-8118
For Media:
Cassidy McClain
Inizio Evoke
cassidy.mcclain@inizioevoke.com
(619) 694-6291
Source: Xencor, Inc.
FAQ
What are Xencor's key clinical-stage oncology programs in solid tumors?
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Who was appointed as Xencor's new Chief Financial Officer?
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What is Xencor's cash balance as of March 31, 2024?
