Entry into a Material Definitive Agreement

On May 29, 2019, Spherix Incorporated, a Delaware corporation (the "Company"), reported that its entered into a Securities Purchase Agreement (the "Purchase Agreement") with a single accredited investor (the "Purchaser") for the sale by the Company of 221,000 shares (the "Shares") of the Company’s common stock, par value $0.0001 per share (the "Common Stock") at a purchase price of $2.60 per share, and pre-funded common stock purchase warrants to purchase up to 86,692 shares of Common Stock (the "Warrants") at a purchase price of $2.5999 per Warrant, which represents the per Share purchase price, less a $0.0001 per share exercise price for each of the Warrants (Filing, 8-K, Spherix, MAY 29, 2019, View Source [SID1234539016]). The Company sold the Shares and Warrants for aggregate gross proceeds of approximately $799,991 which transaction closed on May 31, 2019.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The Purchase Agreement contains customary representations and warranties of the Company, termination rights of the parties and certain covenants of the Company.

The Warrants are immediately exercisable for $0.0001 per share until exercised in full, except that a holder will not have the right to exercise any portion of the Warrant if the holder (together with its affiliates) would beneficially own in excess of 9.99% of the number of shares of Common Stock outstanding immediately after giving effect to the exercise, as such percentage ownership is determined in accordance with the terms of the Warrants. However, any holder may increase or decrease such percentage to any other percentage upon notice to the Company, but in no event in excess of 9.99%, provided that any increase in such percentage shall not be effective until 61 days after such notice. The Warrants may also be exercisable on a "cashless" basis.

The Company received net proceeds of approximately $799,991 from the sale of the Shares and Warrants. The net proceeds will be used for working capital purposes.

The Shares, Warrants and shares of Common Stock underlying the Warrants (the "Warrant Shares") were, or in the case of the Warrant Shares, will be, offered and sold by the Company pursuant to an effective shelf registration statement on Form S-3, which was filed with the Securities and Exchange Commission (the "SEC") on January 9, 2018 and subsequently declared effective on January 19, 2018 (File No. 333-222488) (the "Registration Statement"), and the base prospectus contained therein. The Company filed a prospectus supplement with the SEC on May 31, 2019 in connection with the sale of the Shares, Warrants and Warrant Shares.

A copy of the opinion of Ellenoff Grossman & Schole LLP relating to the legality of the Shares, Warrants and Warrant Shares offered by us is attached as Exhibit 5.1 hereto.

This Current Report on Form 8-K shall not constitute an offer to sell or the solicitation of an offer to buy securities, nor shall there be any sale of securities in any state in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state.

The foregoing is only a brief description of the Purchase Agreement and the Warrant and does not purport to be a complete description thereof. Such descriptions are qualified in their entirety by reference to the forms of the Purchase Agreement and the Warrant, copies of which are filed as Exhibits 10.1 and 4.1, respectively, to this Current Report on Form 8-K and are incorporated by reference herein.

GT BIOPHARMA GTB-1550 PHASE I-II RESULTS TO BE PUBLISHED IN CONJUNCTION WITH 2019 ASCO MEETING MAY 31 – JUNE 4 IN CHICAGO

On May 29, 2019 GT Biopharma, Inc. (OTCQB: GTBP) (OTC: GTBP.PA) an immuno-oncology company focused on innovative treatments based on the Company’s proprietary NK cell engager (TriKE) platform and Multi-Target Directed Bispecific Drug Conjugate (MTBDC) platform, reported that the results of its second Phase I-II trial (NCT02370160) for GTB-1550 (DT2219), an MTBDC targeting CD22 and CD19 for treatment of refractory B-cell malignancies, will be published (J Clin Oncology 37, 2019 suppl; abstract e19066) on-line in conjunction with the 55th Annual Meeting of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) in Chicago from May 31 – June 4 (Press release, GT Biopharma , MAY 29, 2019, View Source [SID1234539514]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Top Line Results Summary:

Treatment was well tolerated at 60 mcg/kg x 8 doses and the most common adverse events included capillary leak syndrome, elevated AST/ALT, low albumin, weight gain and leukopenia. All were Grade 1-2 and resolved after 3-5 days allowing day 15 GTB-1550 administration.
There were no neutropenic fever or immune mediated adverse events. Four patients experienced dose limiting toxicity (DLT) at dose 80 μg/kg/day: Grade 4 capillary leak syndrome (n=1), Grade 3 liver function test (LFT) abnormalities (n=2) and Grade 4 thrombocytopenia >7 days duration (n=1).
Thirteen patients were evaluable for response, and 3 experienced objective clinical benefit. One patient with primary refractory pre-B acute lymphoblastic leukemia achieved complete remission after 1st cycle. Two patients with transformed lymphoma demonstrated transient tumor shrinkage, however, GTB-1550 therapy was discontinued due to DLT and increased neutralizing antibody titer after 1st cycle (pre C1 28%, pre C2 108%).
Correlative studies showed a low incidence of neutralizing antibody in Non-Hodgkin Lymphoma (NHL) patients recently exposed to Rituximab.
Mr. Anthony Cataldo, the Chairman and Chief Executive Officer of GT Biopharma commented, "­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­We are pleased with the results GTB-1550 has shown in the current Phase I-II clinical trial and in our earlier Phase I-II clinical trial. This now positions us to move forward with the FDA phase II clinical trial."

Dr. Veronika Bachanova, Associate Professor of Medicine, Division of Hematology, Oncology and Transplantation at the University of Minnesota and the Principal Investigator for both clinical trials commented, "We are excited about the progress GTB-1550 is making in the clinic, and look forward to the possibility of exploring additional monotherapy and synergistic combination studies against various B-cell malignancies." Both clinical studies were conducted at the University of Minnesota’s Masonic Cancer Center in Minneapolis.

About GTB-1550 Multi-Target Directed Bispecific Therapy

GTB-1550 targets cancer cells expressing the CD19 receptor or CD22 receptor or both receptors thereby maximizing cancer cell recognition by binding to CD19+, CD22+ and CD19+/CD22+ cancer cells. When GTB-1550 binds to cancer cells, the cancer cells internalize GTB-1550, and are killed due to the action of drug’s cytotoxic diphtheria toxin payload. GTB-1550 has previously demonstrated success in a Phase I-II human clinical trial in patients with relapsed/refractory B-cell lymphoma or leukemia. At the time of the interim review, 13 patients met the evaluation criteria, including nine NHL and four ALL patients. More than 50% of patients (seven of 13) exhibited a clinical benefit, defined as stable disease, partial remission or complete remission at Day 29. Of the seven patients, one demonstrated a complete remission (CR), one demonstrated a partial remission (PR) and five demonstrated stable disease (SD).

About the TriKE Platform

The Company’s TriKE product candidates are single-chain, tri-specific scFv recombinant fusion proteins composed of the variable regions of the heavy and light chains (or heavy chain only) of anti-CD16 antibodies, wild-type or a modified form of IL-15 and the variable regions of the heavy and light chains of an antibody designed to precisely target a specific tumor antigen. GT Biopharma utilizes the NK stimulating cytokine human IL-15 as a cross linker between the two scFvs which is designed to provide a self-sustaining signal leading to the proliferation and activation of NK cells thus enhancing their ability to kill cancer cells mediated by antibody-dependent cell-mediated cytotoxicity (ADCC). GT Biopharma has an exclusive worldwide license agreement with the University of Minnesota to further develop and commercialize cancer therapies using proprietary TriKE technology developed by researchers at the university to target NK cells to cancer.

Cambrex to Present at Upcoming Investor Conferences in June

On May 29, 2019 Cambrex Corporation (NYSE: CBM), the leading small molecule company providing drug substance, drug product and analytical services across the entire drug lifecycle, reported that company management will present at the following investor conferences in June (Press release, Cambrex, MAY 29, 2019, View Source [SID1234536633]):

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

William Blair 39th Annual Growth Stock Conference
Date: Wednesday, June 5, 2019
Time: 2:00 p.m. CDT
Location: Chicago, IL

Jefferies 2019 Global Healthcare Conference
Date: Thursday, June 6, 2019
Time: 10:00 a.m. EDT
Location: New York, NY

The live audio webcast and slide presentations can be accessed from the Cambrex website at www.cambrex.com in the Investors section under "Webcasts & Presentations", and replays will be available for 90 days after the live events conclude.

Can-Fite Reports First Quarter 2019 Financial Results & Provides Clinical Update

On May 29, 2019 Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE:CFBI), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address cancer, liver and inflammatory diseases, reported financial results for the three months ended March 31, 2019 (Press release, Can-Fite BioPharma, MAY 29, 2019, View Source [SID1234536649]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Clinical Development and Corporate Highlights During Q1 2019 Include:

●Top Line Results from Phase II Trial of Namodenoson in Liver Cancer – Namodenoson was found to increase overall survival in hepatocellular carcinoma (HCC) patients with Child Pugh B7, the largest subpopulation of the study, as compared to placebo, even though the trial did not meet its primary endpoint. The Company is now preparing for an end-of-Phase II meeting with the FDA to initiate a Phase III study in liver cancer.

●Liver Cancer Data Presentations Accepted at Leading Scientific Conferences – Findings from the Phase II study have been accepted for presentation at two medical conferences that are highly influential in the field of liver cancer. Can-Fite is scheduled to deliver a late-breaking oral presentation at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting on June 2 and is scheduled to deliver an oral presentation at the International Liver Cancer Association (ILCA) annual meeting on September 22.

●Additional Distribution Deal for Namodenoson in Korea – Can-Fite expanded its distribution deal for Namodenoson with Chong Kun Dang Pharmaceuticals (CKD) in South Korea to include the indication of NASH, in addition to the original distribution deal with CKD for Namodenoson in the treatment of liver cancer. For the expanded distribution, CKD paid Can-Fite $1,000,000 upfront, with up to an additional $5,000,000 due upon completion of milestones.

●Manuscript on Can-Fite’s Drugs in CAR-T Published – Drug Design, Development and Therapy published an article about Can-Fite’s drugs’ potential ability to treat Cytokine Release Syndrome (CRS), a potentially fatal side effect of CAR-T and other immune-oncology therapies.

●New Patent Granted in U.S. – The U.S. Patent and Trademark Office issued a Notice of Allowance for Can-Fite’s patent application titled, "Use of A3 adenosine receptor agonist in the treatment of Osteoarthritis." The patent addresses methods for treating osteoarthritis with A3 adenosine receptor (A3AR) agonists and has been granted to Can-Fite in major global markets including North and South America, Europe and Asia.

●Up-Front Money from Newly Signed Deal and Equity Fund Raise – Following the end of the first quarter, Can-Fite received approximately $10.2 million in gross proceeds of which $1 million was received from CKD for the expanded distribution of Namodenoson in South Korea in April and $9.2 million was raised through two registered direct offerings that were completed in April and May. Effective May 10, 2019, Can-Fite changed the ratio of its American Depository Shares (ADSs) to ordinary shares from one ADS representing two ordinary shares to a new ratio of one ADS representing 30 ordinary shares.

"We are effectively advancing our drug pipeline through late stage clinical trials including two Phase III studies for Piclidenoson in auto immune diseases and a planned Phase III for Namodenoson in liver cancer. In the coming months we expect to announce top line results from our Phase II study of Namodenoson in the treatment of NASH," stated Can-Fite CEO Pnina Fishman. "Each one of the four indications we are pursuing addresses unmet needs in multi-billion dollar markets."

Financial Results

Revenues for the three months ended March 31, 2019 were $0.30 million compared to revenues of $0.63 million during the three months ended March 31, 2018. The decrease in revenues for the first quarter of 2019 was mainly due to the recognition of a $0.3 million advance payment received in January 2018 under the Distribution and Supply Agreement with Gebro compared to none in 2019.

Research and development expenses for the three months ended March 31, 2019 were $1.44 million compared with $1.31 million for the same period in 2018. Research and development expenses for the first quarter of 2019 comprised primarily of expenses associated with the Phase II studies for Namodenoson as well as expenses for ongoing studies of Piclidenoson. The increase is primarily due to increased costs associated with the initiation of the Phase III clinical trial of Piclidenoson for the treatment of rheumatoid arthritis.

General and administrative expenses were $0.57 million for the three months ended March 31, 2019 compared to $0.90 million for the same period in 2018. The decrease is primarily due to a decrease in professional services and investor relations expenses.

Financial expense, net for the three months ended March 31, 2019 was $0.12 million compared to financial expense, net of $0.13 million for the same period in 2018. The decrease in financial expense, net in the first quarter of 2019 is considered immaterial.

Can-Fite’s net loss for the three months ended March 31, 2019 was $1.83 million compared with a net loss of $1.72 million for the same period in 2018. As of March 31, 2019, Can-Fite had cash and cash equivalents of $2.96 million as compared to $3.62 million at December 31, 2018. The decrease in cash during the three months ended March 31, 2019 is due to a decrease in net cash used in operating activity of $1.46 million and a decrease in net cash provided by financing activity of $2.4 million.

In April and May 2019, the Company raised $3.2 million and $6 million in gross proceeds, respectively, in registered direct offerings.

The Company’s consolidated financial results for the three months ended March 31, 2019 are presented in accordance with International Financial Reporting Standards.

Illumina to Webcast Upcoming Investor Conference Presentation

On May 29, 2019 Illumina, Inc. (NASDAQ:ILMN) reported that its executives will be speaking at the following investor conference and invited investors to participate via webcast (Press release, Illumina, MAY 29, 2019, View Source [SID1234536665]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Goldman Sachs Global Healthcare Conference in Rancho Palos Verdes, CA
Wednesday, June 12, 2019 at 10:00 am Pacific Time

The live webcast can be accessed in the Investor Relations section of Illumina’s web site under the "company" tab at www.illumina.com. A replay of the presentation will be posted on Illumina’s web site after the event and will be available for at least 30 days following.