– Infinity ended 2022 with total cash and cash
equivalents of $38.3 million –
– Infinity Previously Announced Definitive
Merger Agreement with MEI Pharma to Advance Three Promising
Clinical Oncology Candidates –
Infinity Pharmaceuticals, Inc. (NASDAQ: INFI) (“Infinity” or the
“Company”), a clinical-stage biotechnology company developing
eganelisib, a potential first-in-class, oral, immuno-oncology
macrophage reprogramming therapeutic, today announced its full year
2022 financial results. The Company previously announced on
February 23, 2023 its execution of a definitive merger agreement
with MEI Pharma for a strategic combination of Infinity and MEI,
which is expected to close in mid-2023, subject to approvals by MEI
Pharma and Infinity shareholders and other customary closing
conditions.
Infinity’s Full Year 2022 Financial Results:
- At December 31, 2022, Infinity had total cash and cash
equivalents of $38.3 million, compared to $80.7 million at December
31, 2021.
- Research and development expenses for 2022 were $32.4 million,
compared to $31.6 million in 2021. The increase is primarily
related to an increase in compensation expenses due primarily to
additional staff for the development of eganelisib and an increase
in consulting, partially offset by a decrease in clinical
development expenses.
- General and administrative expenses were $13.5 million for
2022, compared to $14.2 million for 2021. The decrease in G&A
expense is primarily due to a decrease in consulting and
compensation expenses, partially offset by an increase in
information technology support expenses.
- Net loss for 2022 was $44.4 million, or a basic and diluted
loss per common share of $0.50, compared to a net loss of $45.3
million, or a basic and diluted loss per common share of $0.53 in
2021.
Proposed Merger of Infinity Pharmaceuticals with MEI
Pharma:
As previously announced (press release here) and as approved by
the respective Boards of Directors of both companies, on February
23, 2023 MEI and Infinity entered into a merger agreement for an
all-stock transaction with the intent to form a company combining
the expertise and resources of MEI and Infinity to advance a robust
pipeline of three clinical-stage oncology drug candidates. All
three clinical-stage development programs have the potential, in
combination with current therapies, to overcome known resistance
mechanisms and meaningfully improve patient outcomes.
If the merger is consummated, the combined company is projected
to have a ~$100M cash balance at closing which is expected to fund
operations through mid-2025. Importantly, clinical data expected
over the next 12 to 24 months from the combined company’s
clinical-stage oncology development pipeline consists of three
differentiated programs:
- Eganelisib, an oral immuno-oncology macrophage reprogramming
product candidate, which, subject to U.S. Food and Drug
Administration review, is planned to be evaluated in combination
with the PD-1 targeted checkpoint inhibitor pembrolizumab
(KEYTRUDA®) as first line therapy in patients with
relapsed/metastatic head and neck squamous cell carcinoma (HNSCC).
The primary endpoint of the Phase 2 study will be overall survival.
In the second half of 2024 we plan to have initial data on safety
and progression free survival.
- Voruciclib, an oral CDK9 inhibitor, currently being studied in
combination with venetoclax (VENCLEXTA®) in patients with
hematologic malignancies. MEI has provided guidance that the
ongoing Phase 1b trial is expected to report initial results from
the combination regimen around the end of 2023.
- ME-344, a novel tumor selective mitochondrial inhibitor
targeting the OXPHOS pathway, to be evaluated in combination with
bevacizumab (AVASTIN®) in patients with relapsed colorectal cancer.
MEI has provided guidance that data from the Phase 1b trial to
support opening enrollment in an expansion cohort are expected to
be reported around the end of 2023.
In anticipation of the merger, Infinity is investing in
merger-related activities, including transaction costs, in
preparation for the potential initiation of a Phase 2 study of
eganelisib in HNSCC, subject to FDA review, and corporate
restructuring costs including severance and retention payments.
If the merger is not consummated, Infinity expects to have a
cash runway on a stand-alone basis into the second half of 2023,
compared to its most recent guidance of cash runway into 2024. This
shorter cash runway is a result of expenditures related to merger
activities and the advancement of eganelisib. If Infinity does not
successfully consummate the merger, Infinity expects to evaluate
strategic alternatives and if Infinity is unable to enter into
another strategic transaction, the Company’s board of directors may
conclude that it is in the best interest of stockholders to cease
normal operations and wind down the Company through bankruptcy or
dissolution proceedings.
Focus of Eganelisib Development Following the Proposed Merger
as Announced on Feb 23, 2023:
Global Phase 2 Study of Eganelisib in Front Line Head and
Neck Cancer Patients
The lead and most advanced program for the combined company is
planned to be eganelisib. With data supporting multiple paths
forward for eganelisib, a study in head and neck squamous cell
carcinoma (HNSCC) was prioritized based on the ability to leverage
encouraging progression-free survival data generated in head and
neck cancer patients in Infinity’s MARIO-1 clinical trial. In
addition to the encouraging data from MARIO-1, the planned
initiation of a randomized, controlled Phase 2 clinical study
combining eganelisib with pembrolizumab or pembrolizumab in front
line recurrent metastatic HNSCC patients was prioritized
because:
- Pembrolizumab is an approved standard of care in the study
population and an appropriate control arm for the study.
- Patients with recurrent or metastatic HNSCC with a PD-L1
combined positive score of 1 or greater have relatively short
median progression free survival (3.2 months) and median overall
survival (12.3 months) when treated with pembrolizumab monotherapy
(Burtness et al Lancet 2019).
- We believe that the combination regimen of eganelisib plus
pembrolizumab has the potential to demonstrate progression free
survival and overall survival benefits for front line recurrent
metastatic HNSCC patients in a reasonably short period of
time.
- There are a significant number of patients in need.
Eganelisib data in HNSCC Patients from MARIO-1 Study:
The prioritized HNSCC Phase 2 study follows an encouraging
signal from our MAcrophage Reprogramming in Immuno-Oncology-1, or
MARIO-1, study, a Phase 1/1b clinical study designed to evaluate
the safety, tolerability, pharmacokinetics, pharmacodynamics, and
activity for eganelisib — both as a monotherapy and in combination
with nivolumab — in 224 patients with advanced solid tumors. As of
the study’s December 13, 2021 database lock, the median progression
free survival, or mPFS, rate of 3.7 months (1.9, 5.5) was observed
in the HNSCC cohort in patients with immediate prior progression on
CPI therapy. The mPFS for all patients receiving pembrolizumab
monotherapy was 2.3 months in KEYNOTE-048, the benchmark study
investigating pembrolizumab monotherapy, pembrolizumab plus
chemotherapy, or cetuximab plus chemotherapy as a first-line
therapy in recurrent or metastatic HNSCC patients. However, we
caution you that the risks in cross-trial comparisons limit our
ability to reach definitive conclusions without a prospective,
adequately powered, randomized controlled trial. Further, in
MARIO-1, a disease control rate, or DCR, of 36.4% (4 of 11
patients), an overall response rate, or ORR, of 18.2% (2 of 11
patients), and an mPFS rate of 5.3 months (1.9, 11.1) were observed
in the HNSCC cohort in patients with immediate prior progression on
CPI therapy and two or fewer prior lines of therapy. Reversible
hepatic and skin adverse events were the most common toxicities
observed when eganelisib was combined with nivolumab in patients
across all combination cohorts of the MARIO-1 study in patients
with advanced solid tumors.
Encouraging data with eganelisib has been generated in other
patient populations including in patients with front-line
metastatic triple negative breast cancer, or mTNBC, from the
MARIO-3 TNBC study, and in CPI-naïve platinum refractory second
line urothelial cancer patients in the MARIO-275 study, as
summarized in the Company’s Annual Report on Form 10-K for 2022
filed on March 28, 2023.
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. For more information on Infinity, please
refer to Infinity’s website at www.infi.com.
Important Information about the Merger and Where to Find
It
This communication relates to a proposed transaction between
Infinity Pharmaceuticals, Inc. (“Infinity”) and MEI Pharma, Inc.
(“MEI”). In connection with the proposed merger, MEI and Infinity
plan to file with the SEC a registration statement on Form S-4 that
will include a joint proxy statement of MEI and Infinity that also
constitutes a prospectus of MEI. Each of MEI and Infinity also plan
to file other relevant documents with the SEC regarding the
proposed merger. Any definitive joint proxy statement/prospectus
regarding the proposed merger (as amended or supplemented from time
to time, the “Joint Proxy Statement/Prospectus”), if and when
available, will be mailed to stockholders of MEI and Infinity.
INVESTORS AND MEI’S AND INFINITY’S RESPECTIVE STOCKHOLDERS ARE
URGED TO READ THE JOINT PROXY STATEMENT/PROSPECTUS IN ITS ENTIRETY
WHEN IT BECOMES AVAILABLE AND ANY OTHER DOCUMENTS FILED BY EACH OF
MEI AND INFINITY WITH THE SEC IN CONNECTION WITH THE PROPOSED
MERGER OR INCORPORATED BY REFERENCE THEREIN BECAUSE THEY WILL
CONTAIN IMPORTANT INFORMATION ABOUT THE PROPOSED MERGER AND THE
PARTIES TO THE PROPOSED MERGER. Investors and stockholders will be
able to obtain a free copy of the Joint Proxy Statement/Prospectus
and other documents containing important information about MEI and
Infinity, once such documents are filed with the SEC, from the
SEC’s website at www.sec.gov. MEI and Infinity make available free
of charge at www.meipharma.com and www.infi.com, respectively (in
the “Investors” and “Investors/Media” sections, respectively),
copies of materials they file with, or furnish to, the SEC.
Participants in the Solicitation
MEI, Infinity and their respective directors, executive officers
and certain employees and other persons may be deemed to be
participants in the solicitation of proxies from the stockholders
of MEI and Infinity in connection with the proposed merger.
Securityholders may obtain information regarding the names,
affiliations and interests of MEI’s directors and executive
officers in MEI’s Annual Report on Form 10-K for the fiscal year
ended June 30, 2022, which was filed with the SEC on September 8,
2022, and its definitive proxy statement for the 2022 annual
meeting of stockholders, which was filed with the SEC on October
27, 2022. Securityholders may obtain information regarding the
names, affiliations and interests of Infinity’s directors and
executive officers in Infinity’s Annual Report on Form 10-K for the
fiscal year ended December 31, 2022, which was filed with the SEC
on March 28, 2023. Additional information regarding the interests
of such individuals in the proposed merger will be included in the
Joint Proxy Statement/Prospectus relating to the proposed merger
when it is filed with the SEC. These documents (when available) may
be obtained free of charge from the SEC’s website at www.sec.gov,
MEI’s investor website at https://www.meipharma.com/investors and
Infinity’s investor website at https://investors.infi.com/.
No Offer or Solicitation
This communication shall not constitute an offer to sell or the
solicitation of an offer to buy any securities, nor shall there be
any sale of securities in any jurisdiction in which such offer,
solicitation or sale would be unlawful prior to registration or
qualification under the securities laws of any such jurisdiction.
No offering of securities shall be made except by means of a
prospectus meeting the requirements of Section 10 of the U.S.
Securities Act of 1933, as amended.
Cautionary Note Regarding Forward-Looking Statements
Certain statements contained in this press release may be
considered forward-looking statements within the meaning of the
federal securities law. Such statements are based upon current
plans, estimates and expectations of the management of Infinity
that are subject to various risks and uncertainties that could
cause actual results to differ materially from such statements. The
inclusion of forward-looking statements should not be regarded as a
representation that such plans, estimates and expectations will be
achieved. Words such as “anticipate,” “expect,” “project,”
“intend,” “believe,” “may,” “will,” “should,” “plan,” “could,”
“continue,” “target,” “contemplate,” “estimate,” “forecast,”
“guidance,” “predict,” “possible,” “potential,” “pursue,” “likely,”
and words and terms of similar substance used in connection with
any discussion of future plans, actions or events identify
forward-looking statements. All statements, other than historical
facts, including statements regarding: the expected timing of the
closing of the proposed merger; the ability of the parties to
complete the proposed merger considering the various closing
conditions; the expected benefits of the proposed merger, including
estimations of anticipated cost savings and cash runway; the
competitive ability and position of the combined company; the
potential, safety, efficacy, and regulatory and clinical progress
of the combined company’s product candidates, including the
anticipated timing for initiation of clinical trials and release of
clinical trial data and the expectations surrounding potential
regulatory submissions, approvals and timing thereof; the
sufficiency of the combined company’s cash, cash equivalents and
short-term investments to fund operations; the period in which the
Company’s cash on a stand-alone basis is expected to fund
operations; the Company’s plans and ability to execute on an
alternative transaction if the merger is not consummated; the
Company’s intentions to consider strategic alternatives if the
merger is not consummated; and any assumptions underlying any of
the foregoing, are forward-looking statements. Important factors
that could cause actual results to differ materially from
Infinity’s plans, estimates or expectations could include, but are
not limited to: (i) the risk that the proposed merger may not be
completed in a timely manner or at all, which may adversely affect
Infinity’s businesses and the price of its securities; (ii)
uncertainties as to the timing of the consummation of the proposed
merger and the potential failure to satisfy the conditions to the
consummation of the proposed merger, including obtaining
stockholder and regulatory approvals; (iii) the proposed merger may
involve unexpected costs, liabilities or delays; (iv) the effect of
the announcement, pendency or completion of the proposed merger on
the ability of Infinity to retain and hire key personnel and
maintain relationships with customers, suppliers and others with
whom Infinity does business, or on Infinity’s operating results and
business generally; (v) Infinity’s business may suffer as a result
of uncertainty surrounding the proposed merger and disruption of
management’s attention due to the proposed merger; (vi) the outcome
of any legal proceedings related to the proposed merger or
otherwise, or the impact of the proposed merger thereupon; (vii)
Infinity may be adversely affected by other economic, business,
and/or competitive factors; (viii) the occurrence of any event,
change or other circumstances that could give rise to the
termination of the merger agreement and the proposed merger; (ix)
restrictions during the pendency of the proposed merger that may
impact Infinity’s ability to pursue certain business opportunities
or strategic transactions; (x) the risk that Infinity may be unable
to obtain governmental and regulatory approvals required for the
proposed merger, or that required governmental and regulatory
approvals may delay the consummation of the proposed merger or
result in the imposition of conditions that could reduce the
anticipated benefits from the proposed merger or cause the parties
to abandon the proposed merger; (xi) risks that the anticipated
benefits of the proposed merger or other commercial opportunities
may otherwise not be fully realized or may take longer to realize
than expected; (xii) the impact of legislative, regulatory,
economic, competitive and technological changes; (xiii) risks
relating to the value of MEI shares to be issued in the proposed
merger; (xiv) the risk that integration of the proposed merger
post-closing may not occur as anticipated or the combined company
may not be able to achieve the benefits expected from the proposed
merger, as well as the risk of potential delays, challenges and
expenses associated with integrating the combined company’s
existing businesses; (xv) exposure to inflation, currency rate and
interest rate fluctuations, as well as fluctuations in the market
price of MEI’s and Infinity’s traded securities; (xvi) the impact
of the COVID-19 pandemic on MEI’s and Infinity’s industry and
individual companies, including on counterparties, the supply
chain, the execution of clinical development programs, access to
financing and the allocation of government resources; (xvii) final
data from pre-clinical studies and completed clinical trials may
differ materially from reported interim data from ongoing studies
and trials, and there may be uncertainties or differences in
interpretation in clinical trial results; (xviii) results from
early clinical trials may not be replicated in future trials; (xix)
the data and results from MARIO-3 may not be comparable to
IMpassion130, including due to differences in clinical trial
protocols, safety management, sample sizes, duration of treatment,
median duration of follow-up, and other factors; (xx) costs and
delays in the development and/or U.S. Food and Drug Administration
(“FDA”) approval, or the failure to obtain or maintain any such
approval, of Infinity’s or the combined company’s product
candidates or the content and timing of decisions made by the U.S.
FDA and other regulatory authorities in general; (xxi) Infinity’s
or the combined company’s inability to maintain or enter into, and
the risks resulting from dependence upon, collaboration or
contractual arrangements necessary for the development,
manufacture, commercialization, marketing, sales and distribution
of any product candidates; (xxii) the ability of Infinity to
obtain, maintain, protect and enforce intellectual property rights;
(xxiii) the unpredictability and severity of catastrophic events,
including, but not limited to, acts of terrorism or outbreak of war
or hostilities, as well as Infinity’s response to any of the
aforementioned factors; (xxiv) unplanned cash requirements and
expenditures; and (xxv) development of agents by Infinity’s
competitors for diseases in which Infinity is currently developing
or intends to develop eganelisib. Further, there can be no
guarantee that any positive developments in Infinity’s product
portfolio or the completion of the merger will result in stock
price appreciation. Additional factors that may affect the future
results of Infinity are set forth in its filings with the United
States Securities and Exchange Commission (the “SEC”), including
Infinity’s most recently filed Annual Reports on Form 10-K,
subsequent Quarterly Reports on Form 10-Q, Current Reports on Form
8-K and other filings with the SEC, which are available on the
SEC’s website at www.sec.gov. See in particular Infinity’s Annual
Report on Form 10-K for the fiscal year ended December 31, 2022 in
Part I, Item 1A, “Risk Factors,” as filed March 28, 2023. The risks
and uncertainties described above and in the SEC filings cited
above are not exclusive and further information concerning Infinity
and its business, including factors that potentially could
materially affect its business, financial conditions or operating
results, may emerge from time to time. Readers are urged to
consider these factors carefully in evaluating these
forward-looking statements, and not to place undue reliance on any
forward-looking statements. Any such forward-looking statements
represent management’s reasonable estimates and beliefs as of the
date of this communication. While Infinity may elect to update such
forward-looking statements at some point in the future, it
disclaims any obligation to do so, other than as may be required by
law, even if subsequent events cause their views to change.
Keytruda® is a registered trademark of Merck Sharp & Dohme
Corp.
Venclexta ® is a registered trademark of AbbVie Inc.
Avastin® is a registered trademark of Genentech, Inc.
INFINITY PHARMACEUTICALS, INC.
Condensed Consolidated Balance
Sheets
(in thousands)
(unaudited)
December 31, 2022
December 31, 2021
Cash and cash equivalents
$
38,313
$
80,726
Prepaid expenses and other current
assets
1,989
1,542
Property and equipment, net
800
1,241
Other long-term assets
1,049
1,276
Total assets
$
42,151
$
84,785
Accounts payable and accrued expenses
$
13,628
$
13,300
Liability related to sale of future
royalties, net1
47,213
48,727
Operating lease liability, less current
portion
324
917
Long-term liabilities
37
270
Total stockholders’ (deficit) equity
(19,051)
21,571
Total liabilities and stockholders’
(deficit) equity
$
42,151
$
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)
Year Ended December
31,
2022
2021
Royalty revenue
$
2,593
$
1,858
Operating expenses:
Research and development
32,411
31,647
General and administrative
13,463
14,174
Royalty expense1
1,563
1,120
Total operating expenses
47,437
46,941
Loss from operations
(44,844)
(45,083)
Other income (expense):
Investment and other income
655
1
Non-cash interest expense1
(180)
(180)
Total other income (expense)
475
(179)
Net loss
$
(44,369)
$
(45,262)
Basic and diluted loss per common
share
$
(0.50)
$
(0.53)
Basic and diluted weighted average number
of common shares outstanding
89,247,785
85,597,264
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/20230328005829/en/
Investor Relations: Luke Heagle Real Chemistry
lheagle@realchemistry.com
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