Xencor advances ulcerative colitis treatment into Phase 2b study

Published 29/04/2025, 21:10
Xencor advances ulcerative colitis treatment into Phase 2b study

PASADENA, Calif. - Xencor, Inc. (NASDAQ:XNCR), a biopharmaceutical firm focusing on engineered antibodies for cancer and autoimmune diseases, with a current market capitalization of $748 million, announced today that it will be moving its investigational anti-TL1A antibody, XmAb942, into a Phase 2b study for patients with moderate-to-severe ulcerative colitis (UC). According to InvestingPro data, the company maintains a strong liquidity position with a current ratio of 6.61, indicating robust short-term financial stability. This decision follows positive interim results from a dose-escalation study in healthy volunteers, demonstrating the drug’s tolerability and a half-life that supports a 12-week dosing interval.

The Phase 2b study, known as XENITH-UC, is set to commence in the second half of 2025. The trial will assess XmAb942’s efficacy, safety, and pharmacokinetics in UC patients who have not responded adequately to other therapies. With analyst price targets ranging from $22 to $40, significantly above the current trading price of $10.58, market experts appear optimistic about the company’s potential. For deeper insights into Xencor’s valuation and growth prospects, InvestingPro subscribers can access comprehensive analysis and additional ProTips. Approximately 220 patients will be enrolled to receive intravenous doses during a 12-week induction period, followed by subcutaneous doses every 12 weeks for maintenance. The primary endpoint is clinical remission at week 12, as measured by the modified Mayo score.

Xencor’s interim data from the Phase 1 study in healthy volunteers showed that XmAb942 was well tolerated across all dose levels and administration routes, with no serious adverse events or discontinuations due to adverse events reported. The pharmacokinetic analysis revealed a half-life exceeding 71 days, consistent with pre-study estimates and supporting the proposed dosing schedule.

Additionally, the company is progressing with its XmAb TL1A x IL23p19 bispecific antibody program, aiming for a lead selection in preparation for a first-in-human study slated for 2026. In vitro studies indicate that these bispecific candidates match the potency of commercial monospecific antibodies.

Xencor’s President and CEO, Dr. Bassil Dahiyat, expressed optimism about the potential of XmAb942 to offer a best-in-class therapy for IBD patients, emphasizing the drug’s high potency and extended half-life designed to improve both clinical outcomes and patient convenience.

While the company maintains a solid balance sheet with more cash than debt, InvestingPro analysis indicates rapid cash utilization, with negative free cash flow of $208 million in the last twelve months. According to InvestingPro’s Fair Value analysis, Xencor currently appears undervalued, potentially presenting an opportunity for investors interested in the biotech sector. The company will host a conference call and webcast later today to discuss these developments in more detail, with the next earnings report scheduled for May 8, 2025.

The information in this article is based on a press release statement from Xencor, Inc.

In other recent news, Xencor Inc. announced plans to restate its financial statements for the fiscal year ending December 31, 2023, and subsequent quarters through September 30, 2024. The restatement follows identified errors in accounting for a royalty transaction and tax misstatements. Specifically, a royalty transaction with OMERS Life Sciences was misclassified, leading to an understatement of accounts receivable by $12.4 million and an overstatement of deferred income by $156.9 million. This also resulted in understated debt by $168.5 million. Additionally, revenue and interest expenses were understated by $6.3 million and $5.5 million, respectively. Meanwhile, William Blair initiated coverage on Xencor with an Outperform rating, citing the potential of Xencor’s pipeline to generate distinctive clinical data in the next 6 to 12 months. The firm’s confidence is largely attributed to Xencor’s XmAb platform, which has shown promising results in the development of T-cell engagers for cancer treatment. These developments provide investors with insights into both the financial adjustments and the strategic outlook for Xencor.

This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.

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