Xilio Therapeutics Reports Pipeline and Business Highlights and First Quarter 2022 Financial Results
May 12 2022 - 7:30AM
Xilio Therapeutics, Inc. (Nasdaq: XLO), a biotechnology company
developing tumor-selective immuno-oncology therapies for people
living with cancer, today announced pipeline and business
highlights and reported financial results for the first quarter
ended March 31, 2022.
“Leveraging our geographically precise solutions (GPS) platform,
we are developing a pipeline of tumor-selective immunotherapies
that have the potential to achieve meaningful anti-tumor activity
while minimizing serious, systemic effects,” said René Russo,
Pharm.D., president and chief executive officer of Xilio. “We
continue to progress enrollment in our Phase 1 clinical programs,
XTX101 and XTX202, with planned preliminary data readouts later
this year, and we remain on track with our plans to submit an IND
application for XTX301 in the second half of 2022. With our strong
financial position and an outstanding team in place, we believe we
are well-positioned to advance our pipeline of tumor-selective
immuno-oncology programs with the goal of transforming the lives of
people living with cancer.”
Pipeline and Business Progress
Cytokine Programs
- Enrollment is ongoing in the Phase 1 clinical trial evaluating
XTX202 for the treatment of patients with solid tumors, with
preliminary data anticipated to be reported in the second half of
2022. XTX202 is a tumor-selective interleukin-2 (IL-2) designed to
localize activity in the tumor microenvironment, with the goal of
overcoming the known tolerability challenges of existing IL-2
therapies while achieving enhanced anti-tumor activity as
monotherapy and in combination with standard of care agents.
- Preclinical data from the XTX301 program was presented at the
New York Academy of Sciences Frontiers in Cancer Immunotherapy 2022
conference on May 10, 2022. XTX301 demonstrated tumor-selective
activation in patient-derived tumor explants, and a murine
surrogate of XTX301 (mXTX301) induced significant tumor growth
inhibition in a mouse model and improved tolerability compared to a
non-tumor-selective version of mXTX301. View the poster online
here.
- Xilio continues to anticipate submitting an investigational new
drug application (IND) for XTX301, a tumor-selective interleukin-12
(IL-12), in the second half of 2022 for evaluation in patients with
solid tumors.
Upcoming Presentations
- A trials-in-progress poster outlining details of the ongoing
Phase 1/2 clinical trial for XTX202 will be presented at the
American Society of Clinical Oncology (ASCO) 2022 Annual
Meeting:Presentation title: A first-in-human,
multicenter, phase 1/2, open-label study of XTX202, a masked and
tumor-selective recombinant human interleukin-2 (IL-2) protein, in
patients with advanced solid tumorsSession date and
time: Sunday, June 5, 2022, 8:00-11:00 AM
CDTAbstract number: TPS2697
Checkpoint Inhibitor Program
- Enrollment is ongoing in the Phase 1 clinical trial evaluating
XTX101, a tumor-selective anti-CTLA-4 monoclonal antibody, as a
monotherapy and in combination with pembrolizumab, an anti-PD-1,
for the treatment of patients with advanced solid tumors.
- Preliminary data for the Phase 1 clinical trial for XTX101 is
anticipated to be reported from the monotherapy cohort in the
middle of 2022 and from the combination cohort in the second half
of 2022.
First Quarter 2022 Financial Results
- Cash Position: Cash and cash equivalents were
$177.0 million as of March 31, 2022, as compared to $198.1 million
as of December 31, 2021. The decrease was primarily driven by cash
used in operations for the three months ended March 31, 2022.
- Research & Development (R&D) Expenses:
R&D expenses were $14.9 million for the first quarter of 2022,
compared to $11.6 million for the first quarter of 2021. The
increase was primarily driven by increased costs associated with
XTX301 and other preclinical programs, as well as higher
personnel-related costs due to increased headcount.
- General & Administrative (G&A)
Expenses: G&A expenses were $6.3 million for the first
quarter of 2022, compared to $4.9 million for the first quarter of
2021. The increase was primarily driven by higher personnel-related
costs due to increased headcount and other costs related to
operating as a publicly traded company.
- Net Loss: Net loss was $21.4 million for the
first quarter of 2022, compared to $16.7 million for the first
quarter of 2021.
Financial Guidance
As a result of prioritization within the company’s preclinical
portfolio, Xilio now anticipates that its existing cash and cash
equivalents will be sufficient to fund its operating expenses and
capital expenditure requirements into the first half of 2024.
About Xilio Therapeutics
Xilio Therapeutics is a clinical-stage biotechnology company
focused on harnessing the immune system to achieve deep and durable
clinical responses to improve the lives of patients with cancer.
The company is using its proprietary geographically precise
solutions (GPS) platform to rapidly engineer novel molecules,
including cytokines and other biologics, that are designed to
optimize their therapeutic index. These molecules are designed to
localize activity within the tumor microenvironment without
systemic effect, resulting in the potential to achieve enhanced
anti-tumor activity. Xilio is building a pipeline of wholly owned,
tumor-selective, GPS-enabled cytokine and checkpoint inhibitor
product candidates, including its clinical-stage programs, XTX101,
a tumor-selective anti-CTLA-4 monoclonal antibody, and XTX202, a
tumor-selective IL-2, as well as its earlier pipeline, including
XTX301, a tumor-selective IL-12. For more information, please visit
www.xiliotx.com and follow us on Twitter (@xiliotx) and 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 and timing related to reporting preliminary Phase 1
clinical data for XTX101 and XTX202 and the submission of an IND
for XTX301; the potential benefits of any of Xilio’s current or
future product candidates in treating patients; Xilio’s ability to
fund its operating expenses and capital expenditure requirements
with its existing cash and cash equivalents; 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,” “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, risks and uncertainties related to
ongoing and planned research and development activities, including
initiating, conducting or completing preclinical studies 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 programs; 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
current or future operating expenses and capital expenditure
requirements; the impact of international trade policies on Xilio’s
business, including U.S. and China trade policies; and the impact
of the COVID-19 pandemic on Xilio’s business, operations, strategy,
goals and anticipated milestones. 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 Annual Report on Form 10-K 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.
For Investor Inquiries:Sal GiovineChief
Financial Officerinvestors@xiliotx.com
For Media Inquiries: Julissa Viana Vice
President, Corporate Communicationsmedia@xiliotx.com
XILIO THERAPEUTICS, INC.
Condensed Consolidated Balance
Sheets(In
thousands)(Unaudited)
|
March 31, |
|
December 31, |
|
2022 |
|
2021 |
Assets |
|
|
|
|
|
|
|
Cash and cash equivalents |
$ |
176,959 |
|
|
$ |
198,053 |
|
Other assets |
|
19,393 |
|
|
|
20,007 |
|
Total assets |
$ |
196,352 |
|
|
$ |
218,060 |
|
Liabilities and
Stockholders’ Equity |
|
|
|
|
|
|
|
Liabilities |
$ |
30,231 |
|
|
$ |
32,631 |
|
Stockholders’ equity |
|
166,121 |
|
|
|
185,429 |
|
Total liabilities and stockholders’ equity |
$ |
196,352 |
|
|
$ |
218,060 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
XILIO THERAPEUTICS, INC.
Condensed Consolidated Statements of
Operations and Comprehensive Loss(In thousands,
except share and per share
data)(Unaudited)
|
Three Months Ended March
31, |
|
2022 |
|
|
2021 |
|
Operating expenses (1) |
|
|
|
|
|
Research and development |
$ |
14,920 |
|
|
$ |
11,621 |
|
General and administrative |
|
6,304 |
|
|
|
4,899 |
|
Total operating expenses |
|
21,224 |
|
|
|
16,520 |
|
Loss from operations |
|
(21,224 |
) |
|
|
(16,520 |
) |
Other expense, net |
|
|
|
|
|
Other expense, net |
|
(129 |
) |
|
|
(147 |
) |
Total other expense, net |
|
(129 |
) |
|
|
(147 |
) |
Net loss and comprehensive
loss |
$ |
(21,353 |
) |
|
$ |
(16,667 |
) |
Net loss per share, basic and
diluted |
$ |
(0.78 |
) |
|
$ |
(23.53 |
) |
Weighted average common shares outstanding, basic and diluted |
|
27,367,377 |
|
|
|
708,264 |
|
|
|
|
|
|
|
(1) Operating
expenses include the following amounts of non-cash equity-based
compensation expense: |
|
|
|
|
|
|
|
Three Months Ended March
31, |
|
2022 |
|
|
2021 |
|
Research and development
expense |
$ |
596 |
|
|
$ |
135 |
|
General and administrative
expense |
|
1,433 |
|
|
|
659 |
|
Total equity-based compensation expense |
$ |
2,029 |
|
|
$ |
794 |
|
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