This Annual Report contains forward-looking statements within the meaning of
Section 27A of the Securities Act of 1933 and Section 21E of the Securities
Exchange Act of 1934, including statements that contain the words “believes,”
“anticipates,” “expects,” “plans,” “intends” and similar words and phrases.
These forward-looking statements are subject to risks and uncertainties that
could cause actual results to differ materially from the results projected in
any forward-looking statement. In addition to the factors specifically noted in
the forward-looking statements, other important factors, risks and uncertainties
that could result in those differences include, but are not limited to, those
discussed under Item 1A to Part I “Risk Factors” in this Annual Report. The
forward-looking statements are made as of the date of this Annual Report, and we
assume no obligation to update the forward-looking statements, or to update the
reasons why actual results could differ from those projected in the
forward-looking statements. Investors should consult all of the information set
forth in this report and the other information set forth from time to time in
our reports filed with the
Securities Act of 1933 and the Securities Exchange Act of 1934, including our
reports on Forms 10-Q and 8-K.
76
The following discussion should be read in conjunction with the Consolidated
Financial Statements and Notes thereto included in Item 8 of this Annual Report.
Overview
early-stage pharmaceutical companies (the “Pharmaceutical Companies”), through
an investment in
Pharmaceuticals Inc.
equity interest in
stage pharmaceutical company, the activities of the
(“Barer”), a wholly-owned preclinical cancer metabolism research operation, and
Pharmaceutical Companies, the “Healthcare Companies”), a wholly-owned
orthopedic-focused medical device company developing instruments to advance
minimally invasive surgeries. The Company’s primary focus to date, has been to
invest in and fund, discover and develop novel cancer therapies, and we further
seek to expand our portfolio through opportunistic investments in therapeutics
which address high unmet medical needs including through acquisitions, strategic
investments, or in-licensing assets.
Historically, the Company owned real estate assets. In 2020, the Company sold an
office building located in
Fiscal 2022, the Company sold the building at
Jersey
of a commercial building in
asset.
The Company has debt and equity investments in
Inc.
interests and a warrant to purchase additional equity. On
Company entered into a merger agreement to acquire full ownership of
Pharmaceuticals
other stockholders of
Company announced that the AVENGER 500 Phase 3 clinical trial for CPI-613®
(devimistat),
its primary endpoint of significant improvement in overall survival in patients
with metastatic adenocarcinoma of the pancreas, and following a pre-specified
interim analysis, the independent data monitoring committee for the ARMADA 2000
Phase 3 study for devimistat recommended the trial to be stopped due to a
determination that it was unlikely to achieve the primary endpoint (the “Data
Events”). In light of the Data Events, the Company concluded that the prospects
for CPI-613 were uncertain and has fully impaired in its financial statements
for the year ended
investment in
On
(the “Line of Credit Agreement”) with
Data Events, the Company recorded a full reserve on the
Company from
On
terms. Subsequently, on
Statement on Form S-4 related to the proposed Merger.
77
In 2019, the Company established the
small molecule research operation focused on developing a pipeline of novel
therapeutic compounds, including compounds to regulate cancer metabolism with
potentially broader application in other indications beyond cancer. Barer is led
by a team of scientists and academic advisors considered to be among the leading
experts in cancer metabolism, chemistry, and drug development. In addition to
its own internal discovery efforts, Barer is pursuing collaborative research
agreements and in-licensing opportunities with leading scientists from top
academic institutions.
agreements with
technology from the laboratory of Professor
of Chemistry
its SHMT (serine hydroxymethyltransferase) inhibitor program. The Company also
holds a majority equity interest in
(“LipoMedix”), a clinical stage oncological pharmaceutical company based in
pharmaceutical ventures.
As of
a building at
serves as headquarters for the Company and certain other entities and tenants
and an associated 800-car public garage, and a portion of a commercial building
in
Property for a purchase price of approximately
proceeds of approximately
On
held-for-sale criteria and the Company has therefore classified the 520 Property
as held-for-sale in the consolidated balance sheets at
The sale of the 520 Property also represents a significant strategic shift that
will have a major effect on the Company’s operations and financial results.
Therefore, the Company has classified the results of operations related to the
520 Property as discontinued operations in the consolidated statements of
operations and comprehensive loss. Depreciation on the 520 Property has ceased
on
held-for-sale. See Note 2 to our accompanying consolidated financial statements
for further information regarding discontinued operations.
Business Update – COVID-19, War in
In late 2019, a novel strain of coronavirus, SARS-CoV, which causes COVID-19,
was identified and has proved to be highly contagious. It has since spread
extensively throughout the world, including
a global pandemic by the
actively monitors the outbreak, including the spread of new variants of
interest, and its potential impact on the Company’s operations and those of the
Company’s holdings.
Even with growing availability of testing and vaccines and the relaxation of
public health measures that were implemented to limit the spread of the
pandemic, there continues to be uncertainty around the COVID-19 pandemic and its
impact.
The Company had implemented a number of measures to protect the health and
safety of the Company’s workforce including a voluntary work-from-home policy
for the Company’s workforce
restrictions on discretionary business travel. Most of our employees have
returned to working from the office on a part-time basis.
The full impact of the COVID-19 pandemic on the Company will depend on factors
such as the length of time of the pandemic; the responses of federal, state and
local governments; the impact of future variants that may emerge; vaccination
rates among the population; the efficacy of the COVID-19 vaccines; the
longer-term impact of the pandemic on the economy and consumer behavior; and the
effect on our employees, vendors, and other partners.
78
The short and long-term implications of
difficult to predict at this time. The imposition of sanctions and counter
sanctions may have an adverse effect on the economic markets generally and could
impact our business and the companies in which we have investments, financial
condition, and results of operations. Because of the highly uncertain and
dynamic nature of these events, it is not currently possible to estimate the
impact of the Russian –
we have investments.
Results of...
Read More: RAFAEL HOLDINGS, INC. Management’s Discussion and Analysis of Financial Condition and