Xilio Therapeutics, Inc. (Nasdaq: XLO), a clinical-stage
biotechnology company discovering and developing tumor-activated
immuno-oncology therapies for people living with cancer, today
announced pipeline progress and business updates and reported
financial results for the third quarter ended September 30, 2024.
“Throughout the third quarter, our team continued to drive
execution across all stages of our pipeline, including advancing
our clinical development programs for vilastobart, a
tumor-activated, Fc-enhanced anti-CTLA-4, and XTX301, a
tumor-activated IL-12, toward key data milestones and potential
value inflection points,” said René Russo, Pharm.D., president and
chief executive officer of Xilio. “We look forward to sharing
initial data from our Phase 1C dose escalation trial of vilastobart
in combination with atezolizumab as part of a late-breaker poster
presentation at the SITC Annual Meeting. In addition, we continue
to advance multiple promising research-stage programs, including
XTX501, our tumor-activated PD-1/IL-2, and tumor-activated immune
cell engagers.”
Pipeline and Business Updates
Vilastobart (XTX101): tumor-activated
anti-CTLA-4
Vilastobart is an investigational tumor-activated, Fc-enhanced,
high affinity binding anti-CTLA-4 antibody designed to block CTLA-4
and deplete regulatory T cells when activated in the tumor
microenvironment (TME).
- Xilio will present initial Phase 1C dose escalation data for
vilastobart in combination with atezolizumab in a late-breaker
poster presentation at the Society for Immunotherapy of Cancer
(SITC) 39th Annual Meeting taking place in Houston, Texas, from
November 6-10, 2024.
- In addition, Xilio continues to enroll patients in its ongoing
Phase 2 clinical trial evaluating vilastobart in combination with
atezolizumab in patients with metastatic MSS CRC, including
patients with and without liver metastases.
- Xilio expects to report initial Phase 2 data for vilastobart in
combination with atezolizumab in approximately 20 patients with MSS
CRC in the fourth quarter of 2024 and in a total of approximately
40 patients with MSS CRC in the first quarter of 2025.
XTX301: tumor-activated, engineered IL-12
XTX301 is an investigational tumor-activated, engineered IL-12
molecule designed to potently stimulate anti-tumor immunity and
reprogram the TME of poorly immunogenic “cold” tumors towards an
inflamed, or “hot,” state.
- Xilio continues to enroll patients in Phase 1A monotherapy dose
escalation and Phase 1B monotherapy dose expansion of its ongoing
Phase 1 clinical trial of XTX301 in patients with advanced solid
tumors.
- Xilio plans to report safety, pharmacokinetic and
pharmacodynamic data from the ongoing Phase 1 clinical trial for
XTX301 in the fourth quarter of 2024.
Tumor-Activated Bispecific and Immune Cell Engager
Programs
Xilio is leveraging its proprietary platform to advance a
pipeline of research-stage programs for tumor-activated bispecific
and immune cell engager molecules, including tumor-activated immune
cell engagers and tumor-activated effector-enhanced immune cell
engagers.
- XTX501 is a tumor-activated bispecific PD-1/IL-2 designed to
selectively stimulate PD-1 positive antigen-experienced T cells and
enhance their function. XTX501 incorporates masking designed to
overcome IL-2 receptor-mediated clearance and peripheral activity.
Xilio is currently advancing initial investigational new drug
(IND)-enabling activities for XTX501.
- Xilio will present preclinical data from its tumor-activated
SELECTIVE EFFECTOR-ENHANCED CELL ENGAGER (SEECR) format in a poster
session at the SITC Annual Meeting. Details on the poster
presentation can be found here.
Third Quarter 2024 Financial Results
- Cash Position: Cash and cash equivalents
were $61.3 million as of September 30, 2024, compared to $44.7
million as of December 31, 2023.
- License Revenue: License revenue was $2.3
million for the quarter ended September 30, 2024, which consisted
of revenue recognized under the license agreement and stock
purchase agreement with Gilead. No license revenue was recognized
for the quarter ended September 30, 2023.
- Research & Development (R&D)
Expenses: R&D expenses were $10.8 million for the
quarter ended September 30, 2024, compared to $11.1 million for the
quarter ended September 30, 2023. The decrease was primarily driven
by decreased clinical development activities for XTX202, a
tumor-activated, IL-2, decreased spending related to early-stage
programs and indirect research and development costs and decreased
personnel-related costs, partially offset by increased clinical
development activities for vilastobart and XTX301.
- General & Administrative (G&A)
Expenses: G&A expenses were $6.3 million for each
of the quarters ended September 30, 2024 and September 30,
2023.
- Net Loss: Net loss was $14.0 million for
the quarter ended September 30, 2024, compared to $16.7 million for
the quarter ended September 30, 2023.
Financial Guidance
Based on its current operating plans, Xilio anticipates that its
existing cash and cash equivalents as of September 30, 2024, will
be sufficient to fund its operating expenses and capital
expenditure requirements through the end of the second quarter of
2025.
About Vilastobart (XTX101) and the Phase 1/2 Combination
Clinical Trial
Vilastobart is an investigational tumor-activated, Fc-enhanced,
high affinity binding anti-CTLA-4 monoclonal antibody designed to
block CTLA-4 and deplete regulatory T cells when activated in the
tumor microenvironment (TME). In 2023, Xilio entered into a
co-funded clinical trial collaboration with Roche to evaluate
vilastobart in combination with atezolizumab (Tecentriq®) in a
multi-center, open-label Phase 1/2 clinical trial. Xilio is
currently evaluating the safety of the combination in Phase 1C dose
escalation in patients with advanced solid tumors and the safety
and efficacy of the combination in Phase 2 in patients with
metastatic microsatellite stable colorectal cancer with and without
liver metastases. Please refer to NCT04896697 on
www.clinicaltrials.gov for additional details.
About XTX301 and the Phase 1 Clinical Trial
XTX301 is an investigational tumor-activated IL-12 designed to
potently stimulate anti-tumor immunity and reprogram the tumor
microenvironment (TME) of poorly immunogenic “cold” tumors towards
an inflamed or “hot” state. In March 2024, Xilio entered into an
exclusive license agreement with Gilead Sciences, Inc. for Xilio’s
tumor-activated IL-12 program, including XTX301. Xilio is currently
evaluating the safety and tolerability of XTX301 as a monotherapy
in patients with advanced solid tumors in a first-in-human,
multi-center, open-label Phase 1 clinical trial. Please refer to
NCT05684965 on www.clinicaltrials.gov for additional details.
About Xilio Therapeutics
Xilio Therapeutics is a clinical-stage biotechnology company
discovering and developing tumor-activated immuno-oncology (I-O)
therapies with the goal of significantly improving outcomes for
people living with cancer without the systemic side effects of
current I-O treatments. The company is using its proprietary
platform to advance a pipeline of novel, tumor-activated clinical
and preclinical I-O molecules that are designed to optimize the
therapeutic index by localizing anti-tumor activity within the
tumor microenvironment, including tumor-activated cytokines,
antibodies, bispecifics and immune cell engagers. Learn more by
visiting www.xiliotx.com and follow us on LinkedIn (Xilio
Therapeutics, Inc.).
Cautionary Note Regarding
Forward-Looking Statements
This press release contains forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of
1995, as amended, including, without limitation, statements
regarding plans, expectations and anticipated milestones for
vilastobart (XTX101) and XTX301, including plans and timing for
reporting clinical data for each of these programs; the potential
for Xilio to leverage its research platform to develop
tumor-activated bispecific and immune cell engager molecules;
Xilio’s plans and expectations for advancing initial IND-enabling
activities for XTX501; the potential benefits of any of Xilio’s
current or future product candidates in treating patients as a
monotherapy or combination therapy; Xilio’s estimated cash and cash
equivalents and the period in which Xilio expects to have cash to
fund its operations; and Xilio’s strategy, goals and anticipated
financial performance, milestones, business plans and focus. The
words “aim,” “may,” “will,” “could,” “would,” “should,” “expect,”
“plan,” “anticipate,” “intend,” “believe,” “estimate,” “predict,”
“project,” “potential,” “continue,” “seek,” “target” and similar
expressions are intended to identify forward-looking statements,
although not all forward-looking statements contain these
identifying words. Any forward-looking statements in this press
release are based on management’s current expectations and beliefs
and are subject to a number of important risks, uncertainties and
other factors that may cause actual events or results to differ
materially from those expressed or implied by any forward-looking
statements contained in this press release, including, without
limitation, general market conditions; risks and uncertainties
related to ongoing and planned research and development activities,
including initiating, conducting or completing preclinical studies,
including IND-enabling activities, and clinical trials and the
timing and results of such preclinical studies or clinical trials;
the delay of any current or planned preclinical studies or clinical
trials or the development of Xilio’s current or future product
candidates; Xilio’s ability to obtain and maintain sufficient
preclinical and clinical supply of current or future product
candidates; Xilio’s advancement of multiple early-stage immune cell
engager programs, including tumor-activated immune cell engagers
and tumor-activated effector-enhanced immune cell engagers;
initial, preliminary or interim preclinical or clinical data or
results, which may not be replicated in or predictive of future
preclinical or clinical data or results; Xilio’s ability to
successfully demonstrate the safety and efficacy of its product
candidates and gain approval of its product candidates on a timely
basis, if at all; results from preclinical studies or clinical
trials for Xilio’s product candidates, which may not support
further development of such product candidates; actions of
regulatory agencies, which may affect the initiation, timing and
progress of current or future clinical trials; Xilio’s ability to
obtain, maintain and enforce patent and other intellectual property
protection for current or future product candidates; Xilio’s
ability to obtain and maintain sufficient cash resources to fund
its operations; the impact of international trade policies on
Xilio’s business, including U.S. and China trade policies; Xilio’s
ability to maintain its clinical trial collaboration with Roche to
develop vilastobart (XTX101) in combination with atezolizumab; and
Xilio’s ability to maintain its license agreement with Gilead to
develop and commercialize XTX301. These and other risks and
uncertainties are described in greater detail in the sections
entitled “Risk Factor Summary” and “Risk Factors” in Xilio’s
filings with the U.S. Securities and Exchange Commission (SEC),
including Xilio’s most recent Quarterly Report on Form 10-Q and any
other filings that Xilio has made or may make with the SEC in the
future. Any forward-looking statements contained in this press
release represent Xilio’s views only as of the date hereof and
should not be relied upon as representing its views as of any
subsequent date. Except as required by law, Xilio explicitly
disclaims any obligation to update any forward-looking
statements.
This press release contains hyperlinks to information that is
not deemed to be incorporated by reference in this press
release.
TECENTRIQ is a registered trademark of Genentech USA, Inc., a
member of the Roche Group.
Xilio Investor and Media Contact
Scott YoungVice President, Investor Relations and
Corporate Communicationsinvestors@xiliotx.com
XILIO
THERAPEUTICS, INC.Condensed Consolidated
Balance Sheets(In thousands)
(Unaudited)
|
|
|
|
|
|
|
|
| |
|
September 30, |
|
December 31, |
| |
|
2024 |
|
2023 |
| Assets |
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
61,259 |
|
$ |
44,704 |
|
Other assets |
|
|
13,399 |
|
|
16,222 |
|
Total assets |
|
|
74,658 |
|
|
60,926 |
|
Liabilities and Stockholders’ Equity |
|
|
|
|
|
|
|
Liabilities |
|
|
|
|
|
|
|
Deferred revenue |
|
|
34,504 |
|
|
— |
|
Other liabilities |
|
|
19,180 |
|
|
24,099 |
|
Total liabilities |
|
|
53,684 |
|
|
24,099 |
|
Stockholders’ equity |
|
|
20,974 |
|
|
36,827 |
|
Total liabilities and stockholders’ equity |
|
|
74,658 |
|
|
60,926 |
| |
|
|
|
|
|
|
XILIO
THERAPEUTICS, INC.Condensed Consolidated
Statements of Operations and Comprehensive Loss(In
thousands, except share and per share data)
(Unaudited)
| |
|
Three Months EndedSeptember
30, |
|
Nine Months EndedSeptember
30, |
|
|
|
2024 |
|
2023 |
|
2024 |
|
2023 |
|
License revenue |
|
$ |
2,263 |
|
|
$ |
— |
|
|
$ |
4,620 |
|
|
$ |
— |
|
|
Operating expenses (1) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
|
10,759 |
|
|
|
11,051 |
|
|
|
32,375 |
|
|
|
40,400 |
|
|
General and administrative |
|
|
6,307 |
|
|
|
6,310 |
|
|
|
18,261 |
|
|
|
20,603 |
|
|
Restructuring |
|
|
(41 |
) |
|
|
— |
|
|
|
937 |
|
|
|
— |
|
|
Total operating expenses |
|
|
17,025 |
|
|
|
17,361 |
|
|
|
51,573 |
|
|
|
61,003 |
|
|
Loss from operations |
|
|
(14,762 |
) |
|
|
(17,361 |
) |
|
|
(46,953 |
) |
|
|
(61,003 |
) |
|
Other income, net |
|
|
742 |
|
|
|
613 |
|
|
|
1,805 |
|
|
|
2,254 |
|
|
Net loss and comprehensive loss |
|
$ |
(14,020 |
) |
|
$ |
(16,748 |
) |
|
$ |
(45,148 |
) |
|
$ |
(58,749 |
) |
|
Net loss per share, basic and diluted |
|
$ |
(0.22 |
) |
|
$ |
(0.61 |
) |
|
$ |
(0.91 |
) |
|
$ |
(2.14 |
) |
|
Weighted average common shares outstanding, basic and diluted |
|
|
63,465,063 |
|
|
|
27,523,821 |
|
|
|
49,762,800 |
|
|
|
27,475,579 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1) Operating expenses include the following amounts of non-cash
stock-based compensation expense:
| |
|
Three Months Ended September
30, |
|
Nine Months Ended September
30, |
| |
|
2024 |
|
2023 |
|
2024 |
|
|
2023 |
|
Research and development expense |
|
$ |
384 |
|
$ |
548 |
|
$ |
1,275 |
|
$ |
1,670 |
|
General and administrative expense |
|
|
1,190 |
|
|
1,313 |
|
|
3,643 |
|
|
3,782 |
|
Total stock-based compensation expense |
|
$ |
1,574 |
|
$ |
1,861 |
|
$ |
4,918 |
|
$ |
5,452 |
Xilio Therapeutics (NASDAQ:XLO)
過去 株価チャート
から 11 2024 まで 12 2024
Xilio Therapeutics (NASDAQ:XLO)
過去 株価チャート
から 12 2023 まで 12 2024
