NEW YORK, Oct. 21, 2019 /PRNewswire/ -- Spherix
Incorporated (Nasdaq: SPEX) President and CEO, Anthony Hayes, today released a letter to
shareholders outlining the Company's plans for its previously
disclosed dividend distribution.
Dear Fellow Shareholder,
As we accelerate our transformation into an innovative biotech
company, I believe this is the optimal time to provide our
shareholders with a detailed update. I am excited at the
potential for Spherix and believe we have put several important
pieces in place to drive future success.
First, October 21, 2019 is the
record date for our dividend distribution. If you are a
shareholder of record at 5 p.m.
Eastern Standard on that date, you will receive one share of Hoth
Therapeutics, Inc common stock for every 29 shares of Spherix
common stock you own. The distribution of the Hoth shares is
currently anticipated to occur on or about October 28, 2019, subject to effectiveness of the
registration statement for such shares. Spherix will not distribute
fractional shares of Hoth common stock, and any fractional shares
will be rounded down to the nearest whole share.
Aside from the valuable assets already owned by Spherix, it is
time to look forward and build on the successful investment in
Hoth. Upon the closing of the asset acquisition from CBM
BioPharma, Inc. (CBM), Spherix will acquire anticancer drugs that
provide shareholders access to billion-dollar oncology
markets. For example, the global acute myeloid leukemia (AML)
market is expected to reach $2.2
billion by 2025 growing at CAGR 19.6% over the forecast
period.
Beyond the big picture, the CBM assets provide shareholders and
investors with comparable drugs to help establish value in these
growing markets. For example, KPC34 treats acute myeloid
leukemia and has shown tremendous promise in treating
relapsed/refractory AML cancer that has a certain type of
mutation. Tibsovo®, by Agios
Pharmaceuticals, Inc., also treats relapsed/refractory AML that has
a certain mutation of the disease. In July of 2018, the FDA
approved Tibsovo (ivosidenib) for Relapsed or Refractory Acute
Myeloid Leukemia with an IDH1 Mutation after a 177-person, Phase 1
study. According to results published by Agios, Tibsovo
generated $13.7 million in revenue
for the second quarter of 2019 and they expect that to grow.
A terrific result, when you look at the approval timeline for the
drug:
- Dec 26, 2017: Agios
Pharmaceuticals submits new drug application to the FDA for
Ivosidenib for the treatment of patients with relapsed/refractory
AML and an IDH1 Mutation.
- Feb 15, 2018: FDA accepts new
drug application and grants priority review for Ivosidenib in
relapsed or refractory AML with an IDH1 Mutation.
- Jul 20, 2018: FDA Approves
Tibsovo (ivosidenib) for relapsed or refractory Acute Myeloid
Leukemia with an IDH1 Mutation.
Tibsovo is one of three similar AML drugs that have received FDA
Orphan Drug status and Fast Track designation for the treatment of
AML, as well as priority review. The other two drugs are
IDHIFA® (enasidenib) by
Celgene Corporation and XOSPATA® (gilteritinib) by Astellas Pharma
US.
Astellas had a similar approval timeline and revenue results,
reporting sales of around $22 million
for Xospata in the first quarter of fiscal 2019, and has said it
expects that to increase to around $140
million for the full year, with an FDA approval timeline
of:
- Apr 23, 2018 Astellas Submits New
Drug Applications for Approval of Gilteritinib for the Treatment of
FLT3mut+ Relapsed or Refractory Acute Myeloid Leukemia.
- May 29, 2018 U.S. FDA Grants
Priority Review to Astellas' New Drug Application for Gilteritinib
for the Treatment of Adult Patients with Relapsed or Refractory
Acute Myeloid Leukemia (AML).
- Nov 28, 2018 Approval FDA
Approves Xospata (gilteritinib) for Acute Myeloid Leukemia (AML)
with a FLT3 Mutation.
The AML cancer mutation treated by KPC34 is different than the
mutations treated by the drugs referenced above, but these examples
show quantitative comparable for KPC34. Spherix cannot guarantee a
similar result, but we have been working closely with CBM and
Wake Forest University to move KPC34
forward on a similar regulatory approval process.
We understand that timelines and milestones are important.
We project to have the CBM transaction closed before the end of
November, subject to the satisfaction of certain closing
conditions. Thereafter, we intend to continue work on the
clinical trial protocol and finish the Orphan Drug application,
both of which already have a working draft completed.
As you can see, the opportunities in front of us are
significant, and the pathway to value creation, based on comparable
companies, is well-established. I trust you share our
excitement. We look forward to bringing you additional updates as
they materialize.
Thank you for your continued support.
Sincerely,
Anthony Hayes
About Spherix
Spherix Incorporated was launched in
1967 as a scientific research company. Spherix is committed to
advancing innovation by active participation in the patent
market. Spherix draws on portfolios of pioneering technology
patents to partner with and support product innovation.
Forward-Looking Statements
Certain statements in this
press release constitute "forward-looking statements" within the
meaning of the federal securities laws. Words such as "may,"
"might," "will," "should," "believe," "expect," "anticipate,"
"estimate," "continue," "predict," "forecast," "project," "plan,"
"intend" or similar expressions, or statements regarding intent,
belief, or current expectations, are forward-looking statements.
While the Company believes these forward-looking statements are
reasonable, undue reliance should not be placed on any such
forward-looking statements, which are based on information
available to us on the date of this release. These forward looking
statements are based upon current estimates and assumptions and are
subject to various risks and uncertainties, including without
limitation those set forth in the Company's filings with the
Securities and Exchange Commission (the "SEC"), not limited to Risk
Factors relating to its patent business contained therein. Thus,
actual results could be materially different. The Company expressly
disclaims any obligation to update or alter statements whether as a
result of new information, future events or otherwise, except as
required by law.
Contact:
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Investor
Relations:
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Hayden IR
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Brett Mass, Managing
Partner
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Phone: (646)
536-7331
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Email:
brett@haydenir.com
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www.haydenir.com
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Spherix:
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Phone:
212-745-1373
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Email:
investorrelations@spherix.com
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www.spherix.com
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SOURCE Spherix Incorporated