– Positive eganelisib data from two-year
landmark analysis demonstrate durable survival benefit in
urothelial cancer (UC) patients from MARIO-275 –
– MARIO-3 triple negative breast cancer (TNBC)
data update on track by year end –
– Further eganelisib clinical development stage
gated on potential partnership –
– Increased 2022 year-end cash guidance with
runway extended into 2024 –
– Investor conference call to be held today at
4:30 PM EDT –
Infinity Pharmaceuticals, Inc. (NASDAQ: INFI) (“Infinity” or the
“Company”), a clinical-stage biotechnology company developing
eganelisib, a first-in-class, oral, immuno-oncology macrophage
reprogramming therapeutic, today announced its second quarter 2022
financial results, unveiled new positive data from the Phase 2
MARIO-275 clinical trial, and provided a business update.
“Today, we are pleased to announce positive survival data that
shows approximately a doubling of patient survival at the two-year
landmark analysis, a durable benefit for urothelial cancer patients
being treated with eganelisib plus nivolumab versus
standard-of-care nivolumab monotherapy. This impressive magnitude
of benefit is particularly meaningful given this is a second line
patient population whose cancer has progressed following treatment
with a platinum-based chemotherapy,” said Robert Ilaria, Jr., MD,
Chief Medical Officer of Infinity.
“Based on the positive eganelisib data generated to-date in
several indications and settings, we remain in discussions with
multiple parties regarding potential partnerships to further
advance the development of eganelisib,” said Adelene Perkins, Chief
Executive Officer and Chair of Infinity. “At this stage in
eganelisib’s clinical development, and given the current market
environment, we have decided to prioritize establishing potential
partnerships before beginning new efficacy studies, including
MARIO-4 in TNBC and the MARIO-P platform study. Infinity has a
track record of fiscal discipline, and this approach allows us to
focus our current resources on ongoing clinical trials, extend our
cash runway into 2024, and provide the flexibility to accommodate
potential partners’ input on the prioritization and design of our
next studies. These initiatives support our commitment to advancing
development of eganelisib across multiple oncology indications to
maximize value for patients and shareholders.”
Positive MARIO-275 Clinical Trial Results in Second Line
Urothelial Cancer:
- At two-year landmark survival analysis of MARIO-275 as of July
29, 2022, 45% of patients in the eganelisib plus nivolumab arm are
alive compared to 24% of patients in the nivolumab control arm, a
near doubling of survival benefit.
- Durable survival benefit was also seen in the PD-L1-negative
subgroup, with 38% of patients alive at two years in the eganelisib
plus nivolumab arm versus 17% in the control group, over a doubling
of survival in this patient population underserved by checkpoint
inhibitors alone.
- No new safety signals were observed during the extended period
on treatment.
Second Quarter 2022 Financial Results:
- At June 30, 2022, Infinity had total cash, cash equivalents and
available-for-sale securities of $56.6 million, compared to $80.7
million at December 31, 2021.
- Research and development expenses for the second quarter of
2022 were $8.8 million, compared to $8.0 million in the same period
in 2021. The increase is primarily related to an increase in
compensation expense due primarily to new hires during the period
and an increase in consulting expense, partially offset by a
decrease in clinical development expenses.
- General and administrative expenses were $3.5 million for the
second quarter of 2022 as well as for the second quarter of
2021.
- Net loss for the second quarter of 2022 was $12.0 million, or a
basic and diluted loss per common share of $0.13, compared to a net
loss of $11.3 million, or a basic and diluted loss per common share
of $0.13 in the same period in 2021.
- 2022 Financial Outlook: Net Loss: Infinity expects net loss for
2022 to range from $40 million to $50 million.
- Cash and Investments: Infinity expects to end 2022 with a cash,
cash equivalents and available for sale securities balance ranging
from $35 million to $45 million, which provides a cash runway into
2024. Infinity’s financial guidance does not include additional
funding or business development activities.
Conference Call Information
Infinity will host a conference call today, August 9, 2022, at
4:30 PM EDT to discuss these financial results and business
updates. A live webcast of the conference call can be accessed in
the "Investors/Media" section of Infinity's website at
www.infi.com. To participate in the conference call, please dial
(800) 715-9871 (domestic) and (646) 307-1963 (international) five
minutes prior to start time. The conference ID number is 3032412.
An archived version of the webcast will be available on Infinity's
website for 30 days.
About Infinity and Eganelisib
Infinity Pharmaceuticals, Inc. (“Infinity” or the “Company”), is
a clinical-stage biotechnology company developing eganelisib
(IPI-549), a first-in-class, oral, immuno-oncology macrophage
reprogramming therapeutic which is designed to address a
fundamental biologic mechanism of immune suppression in cancer in
multiple clinical studies. MARIO-3 is the first eganelisib
combination study in front-line advanced cancer patients and is
evaluating eganelisib in combination with Tecentriq®and Abraxane®
in front-line TNBC and in combination with Tecentriq and Avastin®
in front-line RCC. MARIO-275 is a randomized, controlled
combination study of eganelisib combined with Opdivo® in I/O naïve
urothelial cancer. For more information on Infinity, please refer
to Infinity's website at www.infi.com.
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. Such forward-looking statements include the Company’s
guidance with respect to net loss, cash and cash equivalents and
cash runway; plans to evaluate and establish potential
partnerships; and the Company's ability to execute on its strategic
plans. Such statements are subject to numerous important factors,
risks and uncertainties that may cause actual events or results to
differ materially from the Company's current expectations. For
example, there can be no guarantee that eganelisib will
successfully complete necessary preclinical and clinical
development phases or will be successful in establishing a
strategic partnership to further the development of eganelisib.
Further, there can be no guarantee that any positive developments
in Infinity's product portfolio will result in stock price
appreciation. Management's expectations and, therefore, any
forward-looking statements in this press release could also be
affected by risks and uncertainties relating to a number of other
factors, including the following: the cost, timing and results of
clinical trials and other development activities that may be
delayed or disrupted by the COVID-19 pandemic or otherwise; the
content and timing of decisions made by the U.S. FDA and other
regulatory authorities; Infinity's ability to obtain and maintain
requisite regulatory approvals; unplanned cash requirements and
expenditures; development of agents by Infinity's competitors for
diseases in which Infinity is currently developing or intends to
develop eganelisib; and Infinity's ability to obtain, maintain and
enforce patent and other intellectual property protection for
eganelisib. These and other risks which may impact management's
expectations are described in greater detail under the caption
"Risk Factors" included in Infinity's annual report and quarterly
reports filed with the Securities and Exchange Commission (SEC),
and in other filings that Infinity makes with the SEC, available
through the Company’s website at www.infi.com. Any forward-looking
statements contained in this press release speak only as of the
date hereof, and Infinity does not undertake and expressly
disclaims any obligation to update any forward-looking statements,
whether as a result of new information, future events or
otherwise.
Opdivo® is a registered trademark of Bristol Myers Squibb.
Tecentriq® is a registered trademark of Genentech, Inc. Abraxane®
is a registered trademark of Abraxis BioScience, LLC., a wholly
owned subsidiary of Bristol Myers Squibb Company. Avastin® is a
registered trademark of Genentech, Inc.
INFINITY PHARMACEUTICALS,
INC.
Condensed Consolidated Balance
Sheets
(in thousands)
(unaudited)
June 30, 2022
December 31, 2021
Cash, cash equivalents and
available-for-sale securities
$
56,575
$
80,726
Other current assets
3,035
1,542
Property and equipment, net
1,017
1,241
Other long-term assets
1,230
1,276
Total assets
$
61,857
$
84,785
Accounts payable and accrued expenses
$
14,339
$
13,300
Liabilities related to sale of future
royalties, net1
47,955
48,727
Operating lease liability, less current
portion
633
917
Long-term liabilities
37
270
Total stockholders’ (deficit) equity
(1,107
)
21,571
Total liabilities and stockholders’
(deficit) equity
$
61,857
$
84,785
1 The company is not obligated to repay
any of the liabilities related to sale of future royalties but
these are recorded as a liability on the balance sheet in
accordance with accounting guidance for royalty monetization.
INFINITY PHARMACEUTICALS,
INC.
Condensed Consolidated
Statements of Operations
(in thousands, except share
and per share amounts)
(unaudited)
Three Months Ended June
30,
Six Months Ended June
30,
2022
2021
2022
2021
Royalty revenue
$
686
$
512
$
1,338
$
979
Operating expenses:
Research and development
8,795
7,957
17,785
16,158
General and administrative
3,495
3,498
7,171
7,064
Royalty expense
414
308
807
590
Total operating expenses
12,704
11,763
25,763
23,812
Loss from operations
(12,018
)
(11,251
)
(24,425
)
(22,833
)
Other income (expense):
Investment and other income
77
27
93
25
Non-cash interest expense1
(45
)
(45
)
(90
)
(90
)
Total other expense
32
(18
)
3
(65
)
Net loss
$
(11,986
)
$
(11,269
)
$
(24,422
)
$
(22,898
)
Basic and diluted loss per common
share:
$
(0.13
)
$
(0.13
)
$
(0.27
)
$
(0.28
)
Basic and diluted weighted average number
of common shares outstanding:
89,161,777
88,661,934
89,158,562
82,230,784
1 The liabilities related to sale of
future royalties will be amortized using the effective interest
method over the life of the arrangements.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20220809005066/en/
Investor Relations: Kevin Lui Real Chemistry
klui@realchemistry.com
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