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 first quarter ended March 31, 2024.
“In the first quarter, our team remained hard at work advancing
our differentiated pipeline of clinical-stage tumor-activated I-O
therapies, and we believe we are well-positioned to execute on
several anticipated near-term clinical milestones and potential
value-drivers in the coming year,” said René Russo, Pharm.D.,
president and chief executive officer of Xilio. “Looking ahead, we
continue to focus on advancing the clinical development of XTX301,
our tumor-activated IL-12, and XTX101, our tumor-activated,
Fc-enhanced anti-CTLA-4, with clinical data from both programs
expected later this year. In addition, we are encouraged by the
progress we have made in our research-stage pipeline to design and
develop tumor-activated bispecific and immune cell engager
molecules.”
Pipeline and Business Updates
XTX101: tumor-activated anti-CTLA-4
XTX101 is an investigational tumor-activated, Fc-enhanced, high
affinity binding anti-CTLA-4 designed to block CTLA-4 and deplete
regulatory T cells when activated (unmasked) in the tumor
microenvironment (TME). XTX101 is currently being evaluated in
combination with atezolizumab in an ongoing Phase 1 clinical trial
in patients with advanced solid tumors.
Xilio plans to:
- Select a recommended Phase 2 dose for XTX101 in combination
with atezolizumab and initiate the Phase 2 portion of the trial in
patients with MSS CRC in the third quarter of 2024.
- Report initial Phase 2 data for XTX101 in combination with
atezolizumab in approximately 20 patients with MSS CRC in the
fourth quarter of 2024 and in approximately 20 additional patients
(40 patients total) 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.
In March 2024, Xilio and Gilead Sciences, Inc. (Gilead)
announced an exclusive license agreement for Xilio’s
tumor-activated IL-12 program, including XTX301, and a stock
purchase agreement with Gilead. Under the terms of the
agreements:
- Xilio received $43.5 million in upfront payments, including a
cash payment of $30.0 million and an initial equity investment by
Gilead of approximately $13.5 million in Xilio common stock.
- In April 2024, Xilio received aggregate gross proceeds of
approximately $3.3 million from an additional private placement
with Gilead under the stock purchase agreement. Xilio is eligible
to receive up to approximately $8.2 million in additional gross
proceeds from up to two additional equity investments by
Gilead.
- In addition to the equity investments by Gilead, Xilio is
eligible to receive up to a total of $592.5 million in contingent
payments under the license agreement, including a $75.0 million
transition fee and specified development, regulatory and
sales-based milestones. Xilio is also eligible to receive tiered
royalties ranging from high single digits to mid-teens on annual
global net product sales.
For more information, read the press release here.
XTX301 is currently being evaluated in Phase 1 monotherapy dose
escalation in patients with advanced solid tumors. Xilio today
reaffirmed plans to report Phase 1 safety, pharmacokinetic and
pharmacodynamic data for XTX301 in patients with advanced solid
tumors in the fourth quarter of 2024.
Tumor-activated bispecific and immune cell engager
programs
Xilio’s research-stage development efforts are focused on
advancing a pipeline of tumor-activated bispecifics and immune cell
engagers, including tumor-activated cell engagers and
tumor-activated effector-enhanced cell engagers.
- In April 2024, Xilio presented preclinical data from the
company’s first bispecific program, XTX501, a tumor-activated
PD-1/IL-2 bispecific development candidate, at the American
Association for Cancer Research (AACR) Annual Meeting 2024 in San
Diego, California. The preclinical data presented at AACR suggest
that XTX501 has the potential to improve upon the anti-tumor
activity of existing PD-1/PD-L1 immunotherapies while maintaining a
favorable therapeutic index. For more information, read the poster
presentation here.
XTX202: tumor-activated, engineered IL-2
XTX202 is an investigational tumor-activated, beta-gamma biased
IL-2 designed to potently stimulate CD8+ effector T cells and
natural killer (NK) cells without concomitant stimulation of
regulatory T cells when activated (unmasked) in the tumor
microenvironment.
- In March 2024, Xilio announced additional data from its Phase 2
clinical trial evaluating XTX202 in patients with metastatic renal
cell carcinoma or unresectable or metastatic melanoma. For more
information, read the press release here.
- In March 2024, Xilio also announced plans to discontinue
further investment in XTX202 as a monotherapy as part of a
strategic portfolio reprioritization. Xilio continues to explore
strategic opportunities to continue to develop XTX202 in
combination with other agents.
Upcoming Presentations
Xilio will present data from the Phase 1/2 trial for XTX202 in
advanced solid tumors in a poster presentation at the 2024 American
Society of Clinical Oncology (ASCO) Annual Meeting in Chicago,
Illinois from May 31 to June 4, 2024.
Poster Title: Phase 1/2 study of XTX202, a
tumor-activated IL-2βγ, in advanced solid tumors.Session
Name: Developmental
Therapeutics—ImmunotherapyAbstract:
2595Session Date and Time: June 1, 2024 at 9:00 am
C.T. – 12:00 pm C.T.
Corporate Updates
- In March 2024, Xilio implemented a strategic portfolio
prioritization designed to focus its resources on rapidly advancing
clinical development for XTX301 and XTX101 and leveraging the
company’s promising research platform to advance differentiated
tumor-activated bispecific and immune cell engager molecules.
- In April 2024, Xilio closed a private placement equity
financing with certain existing accredited investors, including
Bain Capital Life Sciences and Rock Springs Capital, and received
aggregate gross proceeds of approximately $11.3 million, before
deducting placement agent fees and expenses payable by the
company.
First Quarter 2024 Financial Results
- Cash Position: Cash and cash equivalents
were $34.0 million as of March 31, 2024, compared to $44.7 million
as of December 31, 2023. In addition, in April 2024, Xilio received
approximately $44.6 million in gross proceeds related to the
upfront payment under the license agreement with Gilead and the
private placements with certain existing investors and Gilead.
- Research & Development (R&D)
Expenses: R&D expenses were $10.4 million for the
quarter ended March 31, 2024, compared to $16.1 million for the
quarter ended March 31, 2023. The decrease was primarily driven by
decreased spending related to early-stage research programs and
indirect research and development, decreased manufacturing
activities for XTX301, decreased personnel-related costs and a
reduction of XTX101 costs due to a cost-sharing payment earned
under the clinical trial collaboration with F. Hoffmann-La Roche
Ltd. (Roche), partially offset by increases in clinical development
activities for XTX101 and XTX202.
- General & Administrative (G&A)
Expenses: G&A expenses were $6.1 million for the
quarter ended March 31, 2024, compared to $7.4 million for the
quarter ended March 31, 2023. The decrease was primarily driven by
decreased personnel-related costs and professional and consulting
fees.
- Net Loss: Net loss was $17.2 million for
the quarter ended March 31, 2024, compared to $22.6 million for the
quarter ended March 31, 2023.
Financial Guidance
Based on its current operating plans, Xilio anticipates that its
existing cash and cash equivalents as of March 31, 2024, together
with the $30.0 million upfront payment received in April 2024 under
the license agreement with Gilead and approximately $14.6 million
in aggregate gross proceeds received in April 2024 from private
placements with certain existing investors and Gilead, will be
sufficient to fund its operating expenses and capital expenditure
requirements into the second quarter of 2025.
About XTX101 (anti-CTLA-4) and the Phase 1/2 Combination
Clinical Trial
XTX101 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 (unmasked) in
the tumor microenvironment (TME). In the third quarter of 2023,
Xilio entered into a co-funded clinical trial collaboration with
Roche to evaluate XTX101 in combination with atezolizumab
(Tecentriq®) in a multi-center, open-label Phase 1/2 clinical
trial. Xilio is currently evaluating the safety and tolerability of
the combination in patients with advanced solid tumors in the Phase
1 dose escalation portion of the clinical trial. Subject to the
results of Phase 1 combination dose escalation, Xilio plans to
evaluate the safety and efficacy of the combination in the Phase 2
portion of the clinical trial in patients with microsatellite
stable colorectal cancer. Please refer to NCT04896697 on
www.clinicaltrials.gov for additional details.
About XTX301 (IL-12) 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 XTX202 (IL-2) and the Phase 2 Clinical
Trial
XTX202 is an investigational tumor-activated, beta-gamma biased
IL-2 designed to potently stimulate CD8+ effector T cells and
natural killer (NK) cells without concomitant stimulation of
regulatory T cells when activated (unmasked) in the TME. The Phase
2 clinical trial is a multi-center, open-label trial designed to
evaluate the safety and efficacy of XTX202 as a monotherapy in
patients with unresectable or metastatic melanoma and metastatic
renal cell carcinoma who have progressed on standard-of-care
treatment. Please refer to NCT05052268 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 and
antibodies (including bispecifics) and immune cell engagers
(including tumor-activated cell engagers and tumor-activated
effector-enhanced cell engagers). Learn more by visiting
http://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
XTX101, XTX301 and XTX202; Xilio’s intent and ability to explore
strategic opportunities to develop XTX202 in combination with other
agents; the potential for Xilio to leverage its research platform
to develop tumor-activated bispecific and cell engager molecules;
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; Xilio’s ability to successfully achieve the benefits of
the strategic portfolio reprioritization and workforce reduction;
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;
interim or preliminary 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 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 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.
TECENTRIQ is a registered trademark of Genentech USA, Inc., a
member of the Roche Group.
Contacts:
|
Investors:Melissa ForstArgot PartnersXilio@argotpartners.com |
Media:Dan Budwick1ABdan@1abmedia.com |
|
|
|
| |
|
XILIO THERAPEUTICS, INC.Condensed
Consolidated Balance Sheets(In
thousands)(Unaudited) |
| |
| |
|
March 31, |
|
December 31, |
| |
|
2024 |
|
2023 |
|
Assets |
|
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
33,980 |
|
|
$ |
44,704 |
|
|
Other assets |
|
|
48,629 |
|
|
|
16,222 |
|
|
Total assets |
|
$ |
82,609 |
|
|
$ |
60,926 |
|
|
Liabilities and Stockholders’ Equity |
|
|
|
|
|
|
|
|
|
Liabilities |
|
$ |
56,844 |
|
|
$ |
24,099 |
|
|
Stockholders’ equity |
|
|
25,765 |
|
|
|
36,827 |
|
|
Total liabilities and stockholders’ equity |
|
$ |
82,609 |
|
|
$ |
60,926 |
|
| |
|
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, |
| |
|
2024 |
|
|
2023 |
|
| Operating expenses(1) |
|
|
|
|
|
|
|
Research and development |
|
$ |
10,400 |
|
|
$ |
16,131 |
|
|
General and administrative |
|
|
6,139 |
|
|
|
7,395 |
|
|
Restructuring |
|
|
948 |
|
|
|
— |
|
| Total operating expenses |
|
|
17,487 |
|
|
|
23,526 |
|
|
Loss from operations |
|
|
(17,487 |
) |
|
|
(23,526 |
) |
| Other income (expense),
net |
|
|
|
|
|
|
|
Other income (expense), net |
|
|
284 |
|
|
|
880 |
|
|
Total other income (expense), net |
|
|
284 |
|
|
|
880 |
|
| Net loss and comprehensive
loss |
|
$ |
(17,203 |
) |
|
$ |
(22,646 |
) |
| Net loss per share, basic and
diluted |
|
$ |
(0.62 |
) |
|
$ |
(0.83 |
) |
|
Weighted average common shares outstanding, basic and diluted |
|
|
27,912,584 |
|
|
|
27,433,252 |
|
________________________(1) Operating expenses
include the following amounts of non-cash stock-based compensation
expense:
| |
|
Three Months Ended March 31, |
| |
|
2024 |
|
2023 |
|
Research and development expense |
|
$ |
506 |
|
|
$ |
573 |
|
|
General and administrative expense |
|
|
1,327 |
|
|
|
1,218 |
|
| Total stock-based
compensation expense |
|
$ |
1,833 |
|
|
$ |
1,791 |
|
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