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.
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.
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.
SOURCE Spherix Incorporated