– MARIO-3 Update in Patients with 1L TNBC
showing 52% increase in one-year progression free survival rate in
ITT patient population compared to Impassion130 benchmark –
– Business development discussions advancing
with goal of announcing a partnership in Q1 2023 –
– Cash runway into 2024 with $47.2 million in
cash and cash equivalents at end of Q3 2022–
– Investor conference call to be held today at
8:30 AM ET –
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 third quarter 2022
financial results, provided a business update, and in a separate
press release provided more mature data from the Phase 2 MARIO-3 1L
TNBC clinical trial.
“Our top priority is entering into a strategic partnership to
advance eganelisib development and pave the way to eventual
approval. Current business development discussions are directed
towards an initial, focused development plan in a randomized
controlled setting. It is our goal to announce a partnership, and
the focus of the next clinical study for eganelisib, in the first
quarter of 2023,” said Adelene Perkins, Chief Executive Officer and
Chair of Infinity. “We are encouraged by the long-term benefit seen
in front-line TNBC patients reported earlier today from MARIO-3.
These data are consistent with the long-term benefit seen in other
indications in which eganelisib has been studied, giving us
multiple potential paths forward to be prioritized with a
prospective partner.”
MARIO-3 Clinical Update:
The Company reported today an update from its MARIO-3 study of
eganelisib in combination with atezolizumab and nab-paclitaxel in
front-line metastatic triple negative breast cancer (TNBC)
patients: (Press release here)
- Encouraging one-year progression free survival rates in MARIO-3
1L TNBC study regardless of PD-L1 status
- 52% increase in one-year progression free survival rate in ITT
patient population compared to IMpassion130 benchmark
- No new safety signals were observed during the extended period
on treatment, and the MARIO-3 safety profile continued to be
consistent with expectations for the three component drugs.
Third Quarter 2022 Financial Results:
- At September 30, 2022, Infinity had total cash and cash
equivalents of $47.2 million, compared to $80.7 million at December
31, 2021.
- Research and development expenses for the third quarter of 2022
were $7.7 million, compared to $7.1 million in the same period in
2021. The increase is primarily related to higher compensation
expense due to additional staff to support the future development
of eganelisib.
- General and administrative expenses were $3.5 million for the
third quarter of 2022, compared to $3.8 million in the same period
in 2021. The decrease is primarily related to a decrease in
professional services.
- Net loss for the third quarter of 2022 was $10.7 million, or a
basic and diluted loss per common share of $0.12, compared to a net
loss of $10.7 million, or a basic and diluted loss per common share
of $0.12 in the same period in 2021.
2022 Financial Outlook:
Infinity’s 2022 financial guidance remains as follows:
- Net Loss: Infinity continues to expect net loss for 2022 to
range from $40 million to $50 million.
- Cash and Investments: Infinity continues to expect to end 2022
with a cash and cash equivalents 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 even as we move toward a strategic
partnership on eganelisib which is our goal to announce in the
first quarter of 2023.
Conference Call Information
Infinity will host a conference call today, November 14, 2022,
at 8:30 AM ET to discuss these financial results and business
updates. To access the conference call, please register at
https://register.vevent.com/register/BId44f86e6a2af42faadbb2844131346a8.
Upon registering, each participant will be provided with call
details and access codes. All participants are encouraged to join
10 minutes prior to the start time. A live webcast of the
conference call can be accessed from the Events & Presentations
page in the Investors/Media section of Infinity’s website at
www.infi.com. An archived version of the webcast will be available
on Infinity's website for 30 days following the event.
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)
September 30, 2022
December 31, 2021
Cash and cash equivalents
$
47,182
$
80,726
Other current assets
2,168
1,542
Property and equipment, net
906
1,241
Other long-term assets
1,335
1,276
Total assets
$
51,591
$
84,785
Accounts payable and accrued expenses
$
14,200
$
13,300
Liabilities related to sale of future
royalties, net1
47,753
48,727
Operating lease liability, less current
portion
480
917
Long-term liabilities
32
270
Total stockholders’ (deficit) equity
(10,874
)
21,571
Total liabilities and stockholders’
(deficit) equity
$
51,591
$
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 September
30,
Nine Months Ended September
30,
2022
2021
2022
2021
Royalty revenue
$
712
$
428
$
2,050
$
1,407
Operating expenses:
Research and development
7,663
7,073
25,448
23,231
General and administrative
3,501
3,847
10,672
10,911
Royalty expense
429
258
1,236
848
Total operating expenses
11,593
11,178
37,356
34,990
Loss from operations
(10,881
)
(10,750
)
(35,306
)
(33,583
)
Other income (expense):
Investment and other income
209
82
302
107
Non-cash interest expense1
(45
)
(45
)
(135
)
(135
)
Total other income (expense)
164
37
167
(28
)
Net loss
$
(10,717
)
$
(10,713
)
$
(35,139
)
$
(33,611
)
Basic and diluted loss per common
share:
$
(0.12
)
$
(0.12
)
$
(0.39
)
$
(0.40
)
Basic and diluted weighted average number
of common shares outstanding:
89,392,079
88,766,912
89,211,208
84,433,435
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/20221114005337/en/
Luke Heagle Real Chemistry lheagle@realchemistry.com
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