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NICE hits Keytruda with ‘no’ for urothelial cancer

On March 12, 2020 Merck & Co reported that the rejection, which would have been for adults who have had platinum-containing chemotherapy, comes after a review of new evidence collected while the MSD blockbuster was available via the Cancer Drugs Fund.

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NICE says that there is still uncertainty surrounding the long-term benefit of the second-line immunotherapy treatment in comparison with other options, meaning it is not a "cost-effective use of NHS resources at its current price."

The organisation says that the drug will be withdrawn from the Cancer Drugs Fund once final guidance has been published, meaning that no new patients will be offered the treatment, although it will not affect those whose treatment was started before the final guidance was published.

As it stands, the list price for Keytruda is £2,630 per 100mg vial, which would be given as 200mg intravenously every three weeks. Even when the drug is offered with its agreed discount, the most plausible cost-effectiveness estimate remains above what NICE normally considers acceptable, even for end-of-life treatments.

The rejection marks the second NICE ‘no’ for MSD and Keytruda in the last month or so, as the organisation released a draft guidance rejecting the drug in combo with Pfizer’s Inlyta (axitinib) to treat advanced renal cell carcinoma in February.

Urothelial cancer begins in the lining of the bladder and is thought to be caused by prolonged exposure to harmful substances such as those found in tobacco smoke. It is the most common form of bladder cancer and accounts for nine in 10 of all cases.

Entry into a Material Definitive Agreement

On March 12, 2020, Celsion Corporation (the "Company") reported that it has entered into private exchange agreements (the "Exchange Agreements") with certain holders (the "Investors") of warrants issued in connection with the Company’s registered direct offering of common stock and warrants (the "Original Warrants") issued on March 3, 2020 (Press release, Celsion, MAR 12, 2020, View Source [SID1234555549]). The Original Warrants being exchanged provided for the purchase of up to an aggregate of 2,971,428 shares of the Company’s common stock, par value $0.01 per share (the "Common Stock") at an exercise price of $1.15, with an expiration date of September 3, 2025.

Pursuant to the Exchange Agreements, in return for a higher exercise price of $1.24 per share of Common Stock, the Company issued new warrants to the Investors to purchase up to 3,200,000 shares of Common Stock (the "Exchange Warrants") in exchange for the Original Warrants. The Exchange Warrants, like the Original Warrants, are initially exercisable six months following their issuance (the "Initial Exercise Date") and expire on the five year anniversary of the Initial Exercise Date. Other than having a higher exercise price, different issue date, Initial Exercise Date and expiration date, the terms of the Exchange Warrants are identical to those of the Original Warrants, additional terms of which are more fully described under Item 1.01 of the Company’s Current Report on Form 8-K filed on March 3, 2020, which such terms are incorporated herein by reference.

Kitov Announces Pricing of $6.0 Million Public Offering

On March 12, 2020 Kitov Pharma Ltd. ("Kitov") (NASDAQ/TASE: KTOV), a clinical-stage company advancing first-in-class therapies to overcome tumor immune evasion and drug resistance, reported pricing of a public offering of 20,000,000 units at a price to the public of $0.30 per unit, for gross proceeds of $6.0 million, before deducting placement agent fees and other offering expenses payable by Kitov (Press release, Kitov Pharmaceuticals , MAR 12, 2020, View Source [SID1234555545]). Each unit contains one American Depositary Shares ("ADS") (or ADS equivalent) and one warrant to purchase one ADS. Each ADS represents one ordinary share, no par value, of Kitov. The ADSs (or ADS equivalents) and warrants included in the units can only be purchased together in this offering, but will be issued separately and will be immediately separable upon issuance.

H.C. Wainwright & Co. is acting as the exclusive placement agent for the offering.

The warrants will have an exercise price of $0.325 per ADS and will be exercisable at any time after the date of issuance and will expire five years from the date of issuance.

The closing of the sale of the securities is expected to take place on or about March 16, 2020, subject to satisfaction of customary closing conditions.

Kitov intends to use the net proceeds of this offering to fund the development of its oncology drug candidates, acquisition of new assets and for general working capital purposes.

The offering is being made under an effective registration statement on Form F-1 (File No. 333-235729) filed with the Securities and Exchange Commission (the "SEC") and declared effective on March 11, 2020. The offering is being made only by means of a prospectus forming part of the effective registration statement. The final terms of the offering will be disclosed in a final prospectus to be filed with the SEC and made available on the SEC’s website at www.sec.gov. When available, electronic copies of the final prospectus relating to the offering may also be obtained by contacting H.C. Wainwright & Co., 430 Park Avenue, New York, NY 10022, by telephone at (646) 975-6996 or by email at [email protected]. This press release shall not constitute an offer to sell or a solicitation of an offer to buy nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or jurisdiction.

Helix BioPharma Corp. Closes $6.0 Million Private Placement

On March 12, 2020 Helix BioPharma Corp. (TSX: "HBP") ("Helix" or the "Company"), an immuno-oncology company developing innovative drug candidates for the prevention and treatment of cancer, reported it has closed a private placement financing of 5,042,016 units of the Company ("Units") at a price of $1.0332 per Unit, and the concurrent disposition of 1,708,023 shares of the Company’s Polish subsidiary, Helix Immuno-Oncology S.A. ("HIO"), to a third-party purchaser, representing an 15.5% equity stake in HIO (together with the Units, the "Purchased Securities"), for aggregate gross proceeds of CAD $6,000,000, or $1.19 per Purchased Security (Press release, Helix BioPharma, MAR 12, 2020, View Source [SID1234555544]).

Each Unit is comprised of one common share and one common share purchase warrant. Each common share purchase warrant will entitle the holder to purchase one common share at an exercise price of $1.67 and have an expiry of five years from the date of issuance. The terms of the private placement also included the concurrent disposition by the Company of 1,708,023 shares of HIO, representing 15.5% of the outstanding shares of HIO. Following the disposition, the Company owns 51% of the outstanding shares of HIO.

The Company intends to use the net proceeds of the private placement for working capital and research and development activities.

ACM Alpha Consulting Management AG provided financial advisory services to Helix in connection with the private placement.

Galmed Pharmaceuticals Provides Business Update and Reports Fourth Quarter and Year End 2019 Financial Results

On March 12, 2020 Galmed Pharmaceuticals Ltd. (Nasdaq: GLMD) ("Galmed" or the "Company"), a clinical-stage biopharmaceutical company focused on the development of Aramchol, a liver targeted, oral, SCD1 modulator, currently in a Phase 3 clinical trial for the treatment of nonalcoholic steatohepatitis (NASH) and fibrosis provides reported financial results for the three and twelve months ended December 31, 2019 (Press release, Galmed Medical Research, MAR 12, 2020, View Source [SID1234555521]). The Company will host a conference call and webcast at 08:30 ET today.

Financial Summary – Full Year 2019 vs. Full Year 2018; 4Q19 vs. 4Q18:

For the three and twelve months ended December 31, 2019, the Company recorded a net loss of $8.3 and $20.5 million or $0.39 and $0.97 per share, respectively, compared with a net loss of $3.7 million and $9.9 million, or $0.18 and $0.54 per share, for the three and twelve months ended December 31, 2018.

Research and development expenses were $18.2 million for the twelve months ended December 31, 2019, compared with $8.3 million for the twelve months ended December 31, 2018. For the three months ended December 31, 2019, research and development expenses totaled $7.4 million, which compares with $2.7 million for the same period in 2018. The increase during the three and twelve months is mainly due to the preparation and initiation of the ARMOR study.

The Company incurred general and administrative expenses of $4.2 million for the twelve months ended December 31, 2019, compared with $4.4 million for the twelve months ended December 31, 2018. For the three months ended December 31, 2018, general and administrative expenses totaled $1.3 million, which compares with $1.5 million for the same period in 2018. The decrease primarily resulted from a decrease in salaries and benefits expenses of approximately $0.5 million due to lower year-end bonuses.

During the three and twelve months ended December 31, 2019, the Company recognized a net financial income of $0.3 million and $1.9 million, respectively, compared with $0.5 and $0.9 million, respectively, during 2018. The increase during the twelve months ended December 31, 2019 is mainly due to an increase in interest income from marketable debt securities and short-term deposits, as compared to such income in 2018.

Cash and cash equivalents, restricted cash, short-term deposits and marketable debt securities totaled $75.6 million as of December 31, 2019, compared with $90.2 million as of December 31, 2018. The decrease is mainly attributable to our $14.9 million negative cash flow from operations during the twelve months ended December 31, 2019.
Conference Call & Webcast:

Thursday, March 12th @ 8:30am Eastern Time.

Toll Free:

1-877-425-9470

Toll/International:

1-201-389-0878

Israel Toll Free:

1-809-406-247

Conference ID:

13699345

Webcast:

View Source

Replay Dial-In Numbers

Toll Free:

1-844-512-2921

Toll/International:

1-412-317-6671

Replay Pin Number:

13699345

Replay Start:

Thursday, March 12, 2020, 11:30 AM ET

Replay Expiry:

Thursday, March 26, 2020, 11:59 PM ET

About Aramchol and Non-alcoholic Steatohepatitis (NASH)
Aramchol (arachidyl amido cholanoic acid) is a novel fatty acid bile acid conjugate, inducing beneficial modulation of intra-hepatic lipid metabolism. Aramchol’s ability to modulate hepatic lipid metabolism was discovered and validated in animal models, demonstrating downregulation of the three key pathologies of NASH: steatosis, inflammation and fibrosis. The effect of Aramchol on fibrosis is mediated by downregulation of steatosis and directly on human collagen producing cells. Aramchol has been granted Fast Track designation status by the FDA for the treatment of NASH.

NASH is an emerging world crisis impacting an estimated 3% to 5% of the U.S. population and an estimated 2% to 4% globally. It is the fastest growing cause of liver cancer and liver transplant in the U.S. due to the rise in obesity. NASH is the progressive form of non-alcoholic fatty liver disease that can lead to cardiovascular disease, cirrhosis and liver-related mortality.