Category: Alkido Pharma

NEW YORK, Jan. 21, 2020 /PRNewswire/ — Spherix Incorporated (Nasdaq: SPEX) today announced that it has redesigned the company’s website (www.spherix.com) to illuminate the overall digital transformation and recently acquired anti-cancer therapeutics. The new digital platform will emphasize on technology acquired from world renowned institutions such as The University of Texas and Wake Forest University. Our diverse portfolio of therapeutics includes therapies for pancreatic cancer, acute myeloid leukemia (AML), and acute lymphoblastic leukemia (ALL). Treatments such as the DHA-dFdC identified by The University of Texas, has shown positive results in preclinical studies, inhibiting pancreatic tumor growth in clinically relevant transgenic models. In addition, Wake Forest University has provided a method of treatment for (AML) and (ALL) with the drug KPC-34. The launch of our redesigned website will reflect Spherix ongoing commitment to research in biotechnology development and oncological treatment.

About Spherix

Spherix Incorporated, a Delaware corporation (the “Company”), was initially formed in 1967 and is currently a biotechnology company with a diverse portfolio of small-molecule anti-cancer therapeutics.  The Company’s platform consists of patented technology from leading universities and researchers and we are currently in the process of developing an innovative therapeutic drug platform through strong partnerships with world renowned educational institutions, including The University of Texas at Austin and Wake Forest University.  Our diverse pipeline of therapeutics includes therapies for pancreatic cancer, acute myeloid leukemia (AML) and acute lymphoblastic leukemia (ALL). In addition, we are constantly seeking to grow our pipe to treat unmet medical needs in oncology.

www.spherix.com

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 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.

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SOURCE Spherix Incorporated

NEW YORK, Dec. 10, 2019 /PRNewswire/ — Spherix Incorporated (Nasdaq: SPEX) today announced that it has closed the CBM BioPharma, Inc. transaction and is working to develop these cancer drugs.

Building on its successful investment in Hoth Therapeutics, Inc., Spherix now owns a diverse portfolio of early stage small-molecule anti-cancer therapeutics.  The Spherix platform contains patented technology from leading universities and researchers and we seek to develop our innovative drugs through strong partnership with world renowned institutions, such as The University of Texas at Austin and Wake Forest University.  The Company’s diverse pipeline of therapeutics includes therapies for pancreatic cancer, acute myeloid leukemia (AML) and acute lymphoblastic leukemia (ALL). Its pancreatic treatment has shown positive preclinical results for inhibiting pancreatic tumor growth in clinically relevant transgenic mouse models.  The drug has also demonstrated the potential to overcome tumor cell resistance to current chemotherapeutic drugs.  The Company’s AML drug is a next generation targeted therapeutic designed to overcome multiple resistance mechanisms observed with the current standard of care.  In addition, Spherix is continually seeking to grow its pipeline to treat unmet medical needs in oncology.

Anthony Hayes, CEO of Spherix, stated, “The acquisition of these assets is yet another step in the transformation of Spherix into a diversified biotechnology company.  These are exciting drugs and we intend to provide additional information about these drugs and the development plan moving forward.  As the deal has evolved, we have successfully improved the terms for Spherix shareholders, we thank our shareholders for their support during this process.”

About Spherix

Spherix Incorporated is a technology development company committed to the fostering of innovative ideas. Spherix Incorporated was formed in 1967 as a scientific research company.

Our activities generally include the acquisition and development of technology through internal or external research and development. In addition, we seek to acquire existing rights to intellectual property through the acquisition of already issued patents and pending patent applications, both in the United States and abroad. We may alone, or in conjunction with others, develop products and processes associated with technology development.  Recently, the Company has invested in and helped develop technology with Hoth Therapeutics, Inc., DatChat, Inc. and with its recent asset acquisition with CBM BioPharma, Inc. in December 2019.

Forward-Looking Statements

Certain statements made herein are not historical facts but are forward-looking statements for purposes of the safe harbor provisions under The Private Securities Litigation Reform Act of 1995. Forward-looking statements generally are accompanied by words such as “may”, “should”, “would”, “plan”, “intend”, “anticipate”, “believe”, “estimate”, “predict”, “potential”, “seem”, “seek”, “continue”, “future”, “will”, “expect”, “outlook” or other similar words, phrases or expressions. These forward-looking statements include statements regarding Spherix’s and CBM’s industry, future events, the estimated or anticipated future results and benefits of Spheriz following the CBM acquisition, future opportunities for Spherix, and other statements that are not historical facts. These statements are based on the current expectations of Spherix’s management and are not predictions of actual performance. These statements are subject to a number of risks and uncertainties regarding the businesses of Spherix and the transaction, and actual results may differ materially. These risks and uncertainties include, but are not limited to, changes in the business environment in which Spherix or CBM operates, including inflation and interest rates, and general financial, economic, regulatory and political conditions affecting the industry in which Spherix or CBM operates; changes in taxes, governmental laws, and regulations; competitive product and pricing activity; difficulties of managing growth profitably; the inability of the parties to successfully or timely consummate the proposed transaction, including the risk that any required regulatory approvals are not obtained, are delayed or are subject to unanticipated conditions that could adversely affect the combined company or the expected benefits of the transaction; failure to realize the anticipated benefits of the transaction, including as a result of a delay in consummating the transaction or a delay or difficulty in integrating the assets of CBM; uncertainty as to the long-term value of Spherix’s common stock; those discussed in the Spherix’s Annual Reports on Form 10-K and Quarterly Reports on Form 10-Q and other documents of Spherix on file with the SEC or in the registration statement that will be filed with the SEC by Spherix. There may be additional risks that Spherix presently does not know or that Spherix currently believes are immaterial that could also cause actual results to differ from those contained in the forward-looking statements. In addition, forward-looking statements provide Spherix’s expectations, plans or forecasts of future events and views as of the date of this communication. Spherix anticipates that subsequent events and developments will cause Spherix’s assessments to change. However, while Spherix may elect to update these forward- looking statements at some point in the future, Spherix specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing Spherix’s assessments as of any date subsequent to the date of this communication.

Contact:

Investor Relations:
Hayden IR
Brett Maas, Managing Partner
Phone: (646) 536-7331
Email: brett@haydenir.com
www.haydenir.com

Spherix:
Phone: 212-745-1373
Email: investorrelations@spherix.com
www.spherix.com

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SOURCE Spherix Incorporated

NEW YORK, Nov. 27, 2019 /PRNewswire/ — Spherix Incorporated (Nasdaq: SPEX) announced today that additional patent coverage has been granted by the United States Patent & Trademark Office to the patent portfolio being acquired by Spherix, in the field of pancreatic cancer.

Pancreatic cancer is the fourth most common cause of cancer-related deaths in the United States and the eighth worldwide.  The Pancreatic Cancer Action Network Ô predicted that it will move from fourth to the second leading cause of cancer deaths in the US by 2020.  US Patent number 10,463,684 was recently issued to the University of Texas at Austin and being assigned to Spherix as part of the CBM BioPharma, Inc. asset acquisition previously announced.  The patent targets, among other things, pancreatic cancer with a different mechanism than the current standard of care.  The compound has been shown to be effective in cancer cells that are resistant to the current standard of care in preclinical studies and expands the patent coverage for this compound.

About Spherix

Spherix Incorporated is a technology development company committed to the fostering of innovative ideas. Spherix Incorporated was formed in 1967 as a scientific research company.

Forward-Looking Statements

Certain statements made herein are not historical facts but are forward-looking statements for purposes of the safe harbor provisions under The Private Securities Litigation Reform Act of 1995. Forward-looking statements generally are accompanied by words such as “may”, “should”, “would”, “plan”, “intend”, “anticipate”, “believe”, “estimate”, “predict”, “potential”, “seem”, “seek”, “continue”, “future”, “will”, “expect”, “outlook” or other similar words, phrases or expressions. These forward-looking statements include statements regarding Spherix’s and CBM’s industry, future events, the proposed transaction between the parties to the Asset Purchase Agreement, the estimated or anticipated future results and benefits of the Company following the transaction, including the likelihood and ability of the parties to successfully consummate the proposed transaction, future opportunities for the combined company, and other statements that are not historical facts. These statements are based on the current expectations of Spherix’s management and are not predictions of actual performance. These statements are subject to a number of risks and uncertainties regarding the businesses of Spherix and the transaction, and actual results may differ materially. These risks and uncertainties include, but are not limited to, changes in the business environment in which Spherix or CBM operates, including inflation and interest rates, and general financial, economic, regulatory and political conditions affecting the industry in which Spherix or CBM operates; changes in taxes, governmental laws, and regulations; competitive product and pricing activity; difficulties of managing growth profitably; the inability of the parties to successfully or timely consummate the proposed transaction, including the risk that any required regulatory approvals are not obtained, are delayed or are subject to unanticipated conditions that could adversely affect the combined company or the expected benefits of the transaction; failure to realize the anticipated benefits of the transaction, including as a result of a delay in consummating the transaction or a delay or difficulty in integrating the assets of CBM; uncertainty as to the long-term value of Spherix’s common stock; those discussed in the Spherix’s Annual Reports on Form 10-K and Quarterly Reports on Form 10-Q and other documents of Spherix on file with the SEC or in the registration statement that will be filed with the SEC by Spherix. There may be additional risks that Spherix presently does not know or that Spherix currently believes are immaterial that could also cause actual results to differ from those contained in the forward-looking  statements. In addition, forward-looking statements provide Spherix’s expectations, plans or forecasts of future events and views as of the date of this communication. Spherix anticipates that subsequent events and developments will cause Spherix’s assessments to change. However, while Spherix may elect to update these forward- looking statements at some point in the future, Spherix specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing Spherix’s assessments as of any date subsequent to the date of this communication.

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SOURCE Spherix Incorporated

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.

 

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SOURCE Spherix Incorporated

NEW YORK, Oct. 17, 2019 /PRNewswire/ — Spherix Incorporated (Nasdaq: SPEX) today announced that its stock has been upgraded to a “buy” rating from a “hold” rating in a research note issued to investors by ValuEngine Inc. (www.valuengine.com). ValuEngine uses proprietary models to forecast and value individual equities across a diverse set of industries.

Mr. Anthony Hayes, CEO of Spherix stated, “We continue to work towards building value for our shareholders by opportunistically deploying the Company’s capital across several undervalued assets where we can utilize our industry knowledge and expertise to unlock meaningful returns.”

About Spherix

Spherix Incorporated is a technology development company committed to the fostering of innovative ideas. Spherix Incorporated was formed in 1967 as a scientific research company. Our activities generally include the acquisition and development of technology through internal or external research and development. In addition, we seek to acquire existing rights to intellectual property through the acquisition of already issued patents and pending patent applications, both in the United States and abroad. We may alone, or in conjunction with others, develop products and processes associated with technology development and monetizing related intellectual property.

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 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.

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SOURCE Spherix Incorporated

NEW YORK, Oct. 11, 2019 /PRNewswire/ — Spherix Incorporated (Nasdaq: SPEX) today announced that on October 2, 2019, the Board of Directors of Spherix Incorporated (“Spherix”) approved a distribution to Spherix stockholders of 100,000 shares of Hoth Therapeutics, Inc. (“Hoth”) held by Spherix.

Each Spherix stockholder will be entitled to receive one (1) share of Hoth common stock for every twenty-nine (29) shares of Spherix common stock held as of 5 p.m. Eastern Time on October 21, 2019, the record date. Spherix will not distribute fractional shares of Hoth common stock, and any fractional shares will be rounded down to the nearest whole share.

Spherix stockholders do not need to take any action to receive the shares of Hoth common stock, other than be a shareholder of record on October 21, 2019. Spherix stockholders do not need to pay any consideration for, surrender or exchange shares of Spherix common stock.

Mr. Anthony Hayes, CEO of Spherix stated, “Returning capital to shareholders is an important part of our strategy, and the distribution of a portion of our holdings in Hoth is the first step in this endeavor. We continue to work towards becoming a diversified biopharmaceutical company with a compelling portfolio of potential compounds to develop and commercialize.”

About Spherix

Spherix Incorporated is a technology development company committed to the fostering of innovative ideas. Spherix Incorporated was formed in 1967 as a scientific research company.
Our activities generally include the acquisition and development of technology through internal or external research and development. In addition, we seek to acquire existing rights to intellectual property through the acquisition of already issued patents and pending patent applications, both in the United States and abroad. We may alone, or in conjunction with others, develop products and processes associated with technology development. Recently, the Company has invested in and helped develop technology with Hoth Therapeutics, Inc., DatChat, Inc. and entered into an agreement to acquire certain technology assets from CBM BioPharma, Inc.

Forward-Looking Statements

Certain statements made herein are not historical facts but are forward-looking statements for purposes of the safe harbor provisions under The Private Securities Litigation Reform Act of 1995. Forward-looking statements generally are accompanied by words such as “may”, “should”, “would”, “plan”, “intend”, “anticipate”, “believe”, “estimate”, “predict”, “potential”, “seem”, “seek”, “continue”, “future”, “will”, “expect”, “outlook” or other similar words, phrases or expressions. These forward-looking statements include statements regarding Spherix’s and CBM’s industry, future events, the proposed transaction between the parties to the Asset Purchase Agreement, the estimated or anticipated future results and benefits of the Company following the transaction, including the likelihood and ability of the parties to successfully consummate the proposed transaction, future opportunities for the combined company, and other statements that are not historical facts. These statements are based on the current expectations of Spherix’s management and are not predictions of actual performance. These statements are subject to a number of risks and uncertainties regarding the businesses of Spherix and the transaction, and actual results may differ materially. These risks and uncertainties include, but are not limited to, changes in the business environment in which Spherix or CBM operates, including inflation and interest rates, and general financial, economic, regulatory and political conditions affecting the industry in which Spherix or CBM operates; changes in taxes, governmental laws, and regulations; competitive product and pricing activity; difficulties of managing growth profitably; the inability of the parties to successfully or timely consummate the proposed transaction, including the risk that any required regulatory approvals are not obtained, are delayed or are subject to unanticipated conditions that could adversely affect the combined company or the expected benefits of the transaction; failure to realize the anticipated benefits of the transaction, including as a result of a delay in consummating the transaction or a delay or difficulty in integrating the assets of CBM; uncertainty as to the long-term value of Spherix’s common stock; those discussed in the Spherix’s Annual Reports on Form 10-K and Quarterly Reports on Form 10-Q and other documents of Spherix on file with the SEC or in the registration statement that will be filed with the SEC by Spherix. There may be additional risks that Spherix presently does not know or that Spherix currently believes are immaterial that could also cause actual results to differ from those contained in the forward-looking statements. In addition, forward-looking statements provide Spherix’s expectations, plans or forecasts of future events and views as of the date of this communication. Spherix anticipates that subsequent events and developments will cause Spherix’s assessments to change. However, while Spherix may elect to update these forward- looking statements at some point in the future, Spherix specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing Spherix’s assessments as of any date subsequent to the date of this communication.

Contact:

 

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SOURCE Spherix Incorporated

NEW YORK, Oct. 1, 2019 /PRNewswire/ — Spherix Incorporated (Nasdaq: SPEX) President and CEO, Anthony Hayes, today released a letter to shareholders.

Dear Fellow Shareholders,

As previously stated, Spherix is moving forward diligently with the dividend distribution.  Spherix shareholders who are owners of record on the record date to be set by the Spherix board of directors, will be paid the dividend.  That process is on track and moving forward.  We intend to announce a record date shortly.

In addition, I wanted to provide some additional information about the CBM assets that are part of the planned acquisition.  Like other AML drugs that treat certain indications, KPC34 may qualify for Fast Track designation for the treatment of certain types of AML, as well as priority review by the FDA.  Developed at Wake Forest School of Medicine, KPC34 is a proprietary next generation drug that combines a DNA damaging agent with a targeted therapy designed to overcome multiple resistance mechanisms observed with gemcitabine, the current standard of care. KPC34 has also been shown to be more effective in AML relapse cases, notably increasing the lifespan of mice treated with the drug. The competitive benefits of KPC34 include oral application for patients that cannot tolerate repeated cycles of chemotherapy, doubling the mean survival time verse some of the current standard of care treatments and studies further show high activity levels against human AML cells.

Upon the closing of the CBM asset purchase, and following the dividend distribution, we will further update the market on the CBM assets and the status of our other strategic acquisitions.  We understand the desire by shareholders to receive the proposed dividend and information about Company activities during a tumultuous market.  We hope this release provides additional information and assure you we are working diligently to move matters forward.

Thank you for being a shareholder of Spherix.

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.

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SOURCE Spherix Incorporated

NEW YORK, Sept. 17, 2019 /PRNewswire/ — Spherix Incorporated (Nasdaq: SPEX) today announced that the Company has executed an exclusive option agreement (“Option”) with the University of Maryland, Baltimore (UMB) related to its anticancer drug designated PrAg-PAS, a novel protein drug designed by re-engineering the anthrax toxin delivery mechanism so that any one of a number of anticancer drug payloads may be specifically transported into ovarian cancer cells.

The Option includes rights to U.S. Patent Application Serial No. 15/747,255, which is currently under active examination at the U.S. Patent and Trademark Office.  Under the Option, Spherix has until early December of 2019 to complete its due diligence and execute a license agreement for commercial development.

The execution of this Option closely follows shareholder approval on September 5^th of the Asset Purchase Agreement with CBM BioPharma, Inc. (“CBM”), under which Spherix acquires the assets of CBM, including rights to CBM’s lead drug candidate Gem-DHA for the treatment of pancreatic cancer (see press release dated June 26, 2019).  It also follows Spherix’s execution on August 26^th of an option to license anticancer drug G4-1 from the University of Kentucky (see September 11, 2019 Press Release)

Mr. Anthony Hayes, CEO of Spherix stated, “This invention from the University of Maryland, Baltimore is ingenious.  In simple terms, they have modified the Anthrax toxin so that it kills cancer cells, but not other cells.  By using an elegant protein engineering strategy, the inventors have hijacked the complex anthrax toxin delivery mechanism to create a highly efficient drug delivery system specific to ovarian cancer cells.  In mouse models tested, the data show that tumor growth halted following treatment with PrAg-PAS and did not increase compared to the control mice.  The inventors also find that the drug is well-tolerated with no obvious adverse interactions.  I believe that PrAg-PAS has the potential to strongly enhance our anticancer clinical development program and we look forward to completing our diligence on this promising anticancer drug.”

A report of  a related re-engineered PrAg’s anticancer effects has been published in Martin et al. (2015), “Targeting the membrane-anchored serine protease testisin with a novel engineered anthrax toxin prodrug to kill tumor cells and reduce tumor burden,” Oncotarget Vol. 6, 32:33534-53 (the “Martin Paper”) (see https://www.ncbi.nlm.nih.gov/pubmed/26392335).  According to the Martin Paper, after the first injection of PrAg-PCIS, tumor growth arrested and did not increase compared with vehicle treated tumors, over the course of the experiment.  In addition, treatments with the PrAg-PCIS toxin were well-tolerated by the mice and did not appear to have any overt off-target side effects.  Treated mice did not experience substantial weight loss and necropsies revealed no gross abnormalities or organ damage.

“Spherix is an excellent commercial partner for this promising technology,” said Phil Robilotto,  Associate Vice President, Office of Technology Transfer at UMB, and Director of UM Ventures, Baltimore. “They have a strong track record of successfully collaborating with universities and we are very excited by Spherix’s goals for PrAG-PAS program.”

About Spherix

Spherix Incorporated is a technology development company committed to the fostering of innovative ideas. Spherix Incorporated was formed in 1967 as a scientific research company.

Our activities generally include the acquisition and development of technology through internal or external research and development. In addition, we seek to acquire existing rights to intellectual property through the acquisition of already issued patents and pending patent applications, both in the United States and abroad. We may alone, or in conjunction with others, develop products and processes associated with technology development and monetizing related intellectual property.

About University of Maryland, Baltimore
The University of Maryland, Baltimore is commercializing breakthrough therapies, diagnostics and devices, fueling the creation of innovative start-up companies, and attracting industry leaders and entrepreneurs to its thriving campus. Founded in 1807 as the first public medical school in the nation, the University is a fast-growing biomedical research center with nationally ranked professional schools of dentistry, law, medicine, nursing, pharmacy, social work, an interdisciplinary graduate school as well as a 14-acre biomedical research park. www.umaryland.edu

Forward-Looking Statements

Certain statements made herein are not historical facts but are forward-looking statements for purposes of the safe harbor provisions under The Private Securities Litigation Reform Act of 1995. Forward-looking statements generally are accompanied by words such as “may”, “should”, “would”, “plan”, “intend”, “anticipate”, “believe”, “estimate”, “predict”, “potential”, “seem”, “seek”, “continue”, “future”, “will”, “expect”, “outlook” or other similar words, phrases or expressions. These forward-looking statements include statements regarding Spherix’s and CBM’s industry, future events, the proposed transaction between the parties to the Asset Purchase Agreement, the estimated or anticipated future results and benefits of the Company following the transaction, including the likelihood and ability of the parties to successfully consummate the proposed transaction, future opportunities for the combined company, and other statements that are not historical facts. These statements are based on the current expectations of Spherix’s management and are not predictions of actual performance. These statements are subject to a number of risks and uncertainties regarding the businesses of Spherix and the transaction, and actual results may differ materially. These risks and uncertainties include, but are not limited to, changes in the business environment in which Spherix or CBM operates, including inflation and interest rates, and general financial, economic, regulatory and political conditions affecting the industry in which Spherix or CBM operates; changes in taxes, governmental laws, and regulations; competitive product and pricing activity; difficulties of managing growth profitably; the inability of the parties to successfully or timely consummate the proposed transaction, including the risk that any required regulatory approvals are not obtained, are delayed or are subject to unanticipated conditions that could adversely affect the combined company or the expected benefits of the transaction are not obtained; failure to realize the anticipated benefits of the transaction, including as a result of a delay in consummating the transaction or a delay or difficulty in integrating the assets of CBM; delays or failure to obtain any required approvals for the proposed special dividend; uncertainty as to the long-term value of Spherix’s common stock; those discussed in the Spherix’s Annual Reports on Form 10-K and Quarterly Reports on Form 10-Q and other documents of Spherix on file with the SEC or in the registration statement that will be filed with the SEC by Spherix. There may be additional risks that Spherix presently does not know or that Spherix currently believes are immaterial that could also cause actual results to differ from those contained in the forward-looking statements. In addition, forward-looking statements provide Spherix’s expectations, plans or forecasts of future events and views as of the date of this communication. Spherix anticipates that subsequent events and developments will cause Spherix’s assessments to change. However, while Spherix may elect to update these forward- looking statements at some point in the future, Spherix specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing Spherix’s assessments as of any date subsequent to the date of this communication.

 

 

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SOURCE Spherix Incorporated

NEW YORK, Sept. 11, 2019 /PRNewswire/ — Spherix Incorporated (Nasdaq: SPEX) today announced that the Company has executed an exclusive option agreement (“Option”) with the University of Kentucky (UK) related to its anticancer drug designated G4-1, a novel proteasome inhibitor.

Spherix’s Option includes two issued patents, United States Patent Nos. 9,493,439 and 9,586,946, each having expiration dates in the mid-2030’s. The lead inventors for both patents are Chang-Guo Zhan, professor, and Kyung Bo Kim, associate professor, in UK’s College of Pharmacy. Under the Option, Spherix has until late November to complete its due diligence and execute a license agreement for commercial development.

“Early research indicates great potential for the University of Kentucky’s anticancer drug G4-1. The published data is extremely encouraging, especially the drug’s benefits over already-approved drugs,” stated Mr. Anthony Hayes, CEO of Spherix. “We believe G4-1 will be a strong compliment to CBM’s lead compound, the pancreatic drug Gem-DHA, for which a U.S. patent will soon be issued.  We expect it will add great value to our overall clinical development strategy and look forward to completing our diligence on this promising anticancer drug.”

“I am pleased that our team has once again identified and completed a transaction that we believe can yield exceptional financial benefit to Spherix and its shareholders,” added Hayes.

A report of G4-1’s anticancer effects has been published in Miller et al. (2015), Proteasome Inhibitors with Pyrazole Scaffolds from Structure-Based Virtual Screening, J. Med. Chem. 58:2036-2041 (the “Miller Article”).  According to the Miller Article:

• G4-1 is highly effective in mice in suppressing tumor growth in a mouse xenograft model of prostate cancer.
• It demonstrates excellent metabolic stability profiles in mouse and human liver microsomes, as compared with two other FDA-approved proteasome inhibitors, bortezomib (Velcade®) and carfilzomib (Kyprolis®) (“FDA-Approved Drugs”), which are known to undergo rapid metabolic inactivation.
• It was identified from ~340,000 small molecule candidates against the active site of proteosomes.
• It was highly effective in suppressing solid tumor growth in vivo, a utility that the FDA Approved Drugs lack, as clearly demonstrated by multiple clinical trials.
• Its anticancer effect was not negatively impacted in cancer cell line models by acquired resistance to the FDA Approved Drugs.
• It exhibited no apparent systemic toxicity in the xenograft mouse model.

Announcement of Spherix’s exclusive Option with the University of Kentucky follows a recent positive report related to the issuance of a patent application, licensed by CMB BioPharma, Inc. from the University of Texas at Austin, covering CBM’s lead drug candidate Gem-DHA, which is intended for the treatment of pancreatic cancer (see https://ir.spherix.com/news-releases/?qmodStoryID=6754416076980803). The patent application (U.S. Serial No. 15/115.393) is among the assets to be sold to Spherix as part of the previously announced Asset Purchase Agreement between CBM and Spherix. The purchase transaction is subject to customary closing conditions.

About Spherix
Spherix Incorporated is a technology development company committed to the fostering of innovative ideas. Spherix Incorporated was formed in 1967 as a scientific research company.

Our activities generally include the acquisition and development of technology through internal or external research and development. In addition, we seek to acquire existing rights to intellectual property through the acquisition of already issued patents and pending patent applications, both in the United States and abroad. We may alone, or in conjunction with others, develop products and processes associated with technology development and monetizing related intellectual property.

Forward-Looking Statements
Certain statements made herein are not historical facts but are forward-looking statements for purposes of the safe harbor provisions under The Private Securities Litigation Reform Act of 1995. Forward-looking statements generally are accompanied by words such as “may”, “should”, “would”, “plan”, “intend”, “anticipate”, “believe”, “estimate”, “predict”, “potential”, “seem”, “seek”, “continue”, “future”, “will”, “expect”, “outlook” or other similar words, phrases or expressions. These forward-looking statements include statements regarding Spherix’s and CBM’s industry, future events, the proposed transaction between the parties to the Asset Purchase Agreement, the estimated or anticipated future results and benefits of the Company following the transaction, including the likelihood and ability of the parties to successfully consummate the proposed transaction, future opportunities for the combined company, and other statements that are not historical facts. These statements are based on the current expectations of Spherix’s management and are not predictions of actual performance. These statements are subject to a number of risks and uncertainties regarding the businesses of Spherix and the transaction, and actual results may differ materially. These risks and uncertainties include, but are not limited to, changes in the business environment in which Spherix or CBM operates, including inflation and interest rates, and general financial, economic, regulatory and political conditions affecting the industry in which Spherix or CBM operates; changes in taxes, governmental laws, and regulations; competitive product and pricing activity; difficulties of managing growth profitably; the inability of the parties to successfully or timely consummate the proposed transaction, including the risk that any required regulatory approvals are not obtained, are delayed or are subject to unanticipated conditions that could adversely affect the combined company or the expected benefits of the transaction are not obtained; failure to realize the anticipated benefits of the transaction, including as a result of a delay in consummating the transaction or a delay or difficulty in integrating the assets of CBM; delays or failure to obtain any required approvals for the proposed special dividend; uncertainty as to the long-term value of Spherix’s common stock; those discussed in the Spherix’s Annual Reports on Form 10-K and Quarterly Reports on Form 10-Q and other documents of Spherix on file with the SEC or in the registration statement that will be filed with the SEC by Spherix. There may be additional risks that Spherix presently does not know or that Spherix currently believes are immaterial that could also cause actual results to differ from those contained in the forward-looking statements. In addition, forward-looking statements provide Spherix’s expectations, plans or forecasts of future events and views as of the date of this communication. Spherix anticipates that subsequent events and developments will cause Spherix’s assessments to change. However, while Spherix may elect to update these forward- looking statements at some point in the future, Spherix specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing Spherix’s assessments as of any date subsequent to the date of this communication.

 

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SOURCE Spherix Incorporated