On July 19, 2024, CASI Pharmaceuticals, Inc., a Cayman Islands incorporated company ("CASI" or the "Company") reported that, with respect to the Company’s previously announced dispute with Juventas Cell Therapy Ltd. ("Juventas"), a court of P.R.C. issued an asset freezing order against Juventas in aid of the arbitration proceedings CASI initiated at the Hong Kong International Arbitration Centre (the "HKIAC") in connection to Juventas’s purported termination of the parties’ agreements with respect to the commercialization of CNCT19 (the "Arbitration Proceeding") (Press release, CASI Pharmaceuticals, JUL 19, 2024, View Source [SID1234644980]).

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In an order dated July 15, 2024 and received by CASI on July 18, 2024, the First Intermediate People’s Court of Tianjin Municipality, where Juventas is headquartered, granted CASI’s application to freeze Juventas’s assets while the Arbitration Proceeding is ongoing and decided to freeze up to RMB 190 million in Juventas’s bank accounts or seize and freeze Juventas’s other assets of equivalent value (the "Asset Freezing Order"). The Asset Freezing Order took effect upon issuance and the court has taken steps to enforce the Asset Freezing Order.

The Company will continue to vigorously assert and enforce its rights against Juventas through all available legal means. The Company cannot predict right now the final outcome of the Arbitration Proceeding or how the parties’ dispute would ultimately be resolved.

On July 19, 2024 Ultragenyx Pharmaceutical Inc. (NASDAQ: RARE), a biopharmaceutical company focused on the development and commercialization of novel therapies for rare and ultrarare diseases, reported the grant of 19,875 restricted stock units of the company’s common stock to 14 newly hired non-executive officers of the company. The awards were approved by the compensation committee of the company’s board of directors and granted under the Ultragenyx Employment Inducement Plan, with a grant date of July 16, 2024, as an inducement material to the new employees entering into employment with Ultragenyx in accordance with Nasdaq Listing Rule 5635(c)(4) (Press release, Ultragenyx Pharmaceutical, JUL 19, 2024, View Source [SID1234644978]).

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The restricted stock units vest over four years, with 25% of the underlying shares vesting on each anniversary of the grant date, subject to the employee being continuously employed by the company as of such vesting dates.

On July 19, 2024 Purple biotech presented its corporate presentation (Presentation, Purple Biotech, JUL 19, 2024, View Source [SID1234644977]).

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On July 19, 2024 Biodexa Pharmaceuticals PLC ("Biodexa" or the "Company") (Nasdaq: BDRX), an acquisition-focused clinical stage biopharmaceutical company developing a pipeline of innovative products for the treatment of diseases with unmet medical needs, reported that it has entered into definitive agreements with certain institutional investors to sell an aggregate of (i) 5,050,808 American Depositary Shares (the "Depositary Shares") (each Depositary Share representing 400 of the Company’s ordinary shares, nominal value £0.001 per share) and (ii) 278,975 pre-funded warrants exercisable for Depositary Shares, at a purchase price of $0.94 per Depositary Share (or $0.9399 per pre-funded warrant) in a registered direct offering (Press release, Biodexa Pharmaceuticals, JUL 19, 2024, View Source [SID1234644976]).

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The gross proceeds from the offering are expected to be approximately $5.0 million, before deducting placement agent fees and other estimated offering expenses. The Company anticipates that the proceeds of this offering will be used to fund its development programs, including to provide the final match payment with respect to a $17 million grant from the Cancer Prevention Research Institute of Texas (CPRIT) and initiate the Phase 3 clinical trial of eRapa in Familial Adenomatous Polyposis (FAP), for working capital and for general corporate purposes.
In a concurrent private placement, the Company has also agreed to issue and sell unregistered Series J warrants to purchase up to an aggregate of 5,329,783 Depositary Shares (the "Series J Warrants") and unregistered Series K warrants to purchase up to an aggregate of 5,329,783 Depositary Shares (the "Series K Warrants"). The offering is expected to close on or about July 22, 2024, subject to the satisfaction of customary closing conditions.

The pre-funded warrants have an exercise price of $0.0001 per Depositary Share, will be immediately exercisable and will not expire. The Series J Warrants have an exercise price of $1.00 per Depositary Share, will be immediately exercisable and will expire on the fifth anniversary of the issuance date. The Series K Warrants have an exercise price of $1.00 per Depositary Share, will be immediately exercisable and will expire on the first anniversary of the issuance date.

Ladenburg Thalmann & Co. Inc. acted as sole placement agent in connection with the offering.

In connection with the offering, the Company has also agreed to amend the exercise price of existing Series E warrants to purchase an aggregate of 978,233 Depositary Shares, existing Series G warrants to purchase an aggregate of 2,443,995 Depositary Shares and existing Series H warrants to purchase an aggregate of 3,236,345 Depositary Shares that were previously issued in December 2023, May 2022 and May 2022, respectively, held by investors participating in the offering, such that, effective upon the closing of the offering, the amended warrants will have an exercise price of $1.00 per share.

The Depositary Shares (or pre-funded warrants in lieu thereof) are being offered pursuant to a shelf registration statement on Form F-3 (File No. 333-267932), which was declared effective by the United States Securities and Exchange Commission ("SEC") on October 26, 2022. A prospectus supplement relating to the Depositary Shares and pre-funded warrants will be filed with the SEC and will be available on the SEC’s website located at View Source Electronic copies of the prospectus supplement relating to the registered direct offering, together with the accompanying prospectus, may be obtained, when available, from Ladenburg Thalmann & Co. Inc., Prospectus Department, 640 Fifth Avenue, 4th Floor, New York, New York 10019 or by email at [email protected].

The private placement of the Series J Warrants and Series K Warrants are being made in a transaction not involving a public offering and the securities to be sold in the private placement have not been registered under the Securities Act of 1933, as amended (the "Securities Act"), or any state or other applicable jurisdiction’s securities laws, and may not be offered or sold in the United States absent registration or an applicable exemption from the registration requirements of the Securities Act and applicable state or other jurisdictions’ securities laws. Pursuant to the securities purchase agreement, the Company has agreed to file a registration statement with the SEC registering the resale of the ordinary shares underlying the Depositary Shares issuable upon the exercise of the Series J Warrants and Series K Warrants issued in the private placement.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any offer, solicitation or sale of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful. Any offering of the securities under the resale registration statement will only be made by means of a prospectus.

On July 19, 2024 GSK plc (LSE/NYSE: GSK) reported that the European Medicines Agency (EMA) has accepted the marketing authorisation application (MAA) for Blenrep (belantamab mafodotin) in combination with bortezomib plus dexamethasone (BorDex) or pomalidomide plus dexamethasone (PomDex) as a treatment for relapsed or refractory multiple myeloma (Press release, GlaxoSmithKline, JUL 19, 2024, View Source [SID1234644975]). The EMA’s Committee for Medicinal Products for Human Use (CHMP) will begin the formal review process to make a recommendation to the European Commission regarding this potential authorisation.

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Hesham Abdullah, Senior Vice President, Global Head Oncology, R&D, GSK, said: "Today’s milestone reinforces the potential for Blenrep to redefine outcomes for patients with multiple myeloma at or after first relapse. We are working to bring Blenrep to patients as quickly as possible given the high unmet need and the clinically robust effects of the Blenrep combinations in the DREAMM-7 and DREAMM-8 phase III head-to-head trials."

The application is based on interim results from the DREAMM-7 and DREAMM-8 phase III trials, which both met their primary endpoints, showing statistically significant and clinically meaningful improvements in progression-free survival (PFS) for the belantamab mafodotin combinations compared to standard of care combinations in relapsed or refractory multiple myeloma. The DREAMM-7 trial is evaluating belantamab mafodotin combined with BorDex versus daratumumab plus BorDex, while the DREAMM-8 trial is evaluating belantamab mafodotin in combination with PomDex versus bortezomib plus PomDex.

A positive overall survival (OS) trend was observed in both trials but was not statistically significant at the time of interim analysis. Follow-up for OS continues. Results also showed clinically meaningful improvements across all other secondary efficacy endpoints, including deeper and more durable responses compared to the respective standard of care combinations. The safety and tolerability profiles of the belantamab mafodotin combinations in DREAMM-7 and DREAMM-8 trials were broadly consistent with the known profiles of the individual agents.

About multiple myeloma
Multiple myeloma is the third most common blood cancer globally and is generally considered treatable but not curable.1,2 There are approximately more than 180,000 new cases of multiple myeloma diagnosed globally each year, including approximately 50,000 new cases in Europe.3,4 Research into new therapies is needed as multiple myeloma commonly becomes refractory to available treatments.5

About DREAMM-7
The DREAMM-7 phase III clinical trial is a multicentre, open-label, randomised trial evaluating the efficacy and safety of belantamab mafodotin in combination with BorDex compared to a combination of daratumumab and BorDex in patients with relapsed/refractory multiple myeloma who previously were treated with at least one prior line of multiple myeloma therapy, with documented disease progression during or after their most recent therapy.

A total of 494 participants were randomised at a 1:1 ratio to receive either belantamab mafodotin in combination with BorDex or a combination of daratumumab and BorDex. Belantamab mafodotin was scheduled to be dosed at 2.5mg/kg intravenously every three weeks.

The primary endpoint is PFS as per an independent review committee. The key secondary endpoints include OS, duration of response (DOR), and minimal residual disease (MRD) negativity rate as assessed by next-generation sequencing. Other secondary endpoints include overall response rate (ORR), safety and patient reported and quality of life outcomes.

Results from DREAMM-7 were first presented6 at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Plenary Series in February 2024, shared in an encore presentation at the 2024 ASCO (Free ASCO Whitepaper) Annual Meeting, and published in the New England Journal of Medicine.

About DREAMM-8
The DREAMM-8 phase III clinical trial is a multicentre, open-label, randomised trial evaluating the efficacy and safety of belantamab mafodotin in combination with PomDex compared to a combination of bortezomib and PomDex in patients with relapsed/refractory multiple myeloma previously treated with at least one prior line of multiple myeloma therapy, including a lenalidomide-containing regimen, and who have documented disease progression during or after their most recent therapy. Compared to the patient population studied in the DREAMM-7 trial, patients in DREAMM-8 were more heavily pre-treated in that all had prior exposure to lenalidomide, 75% were refractory to lenalidomide, 25% had prior daratumumab exposure and of those most were daratumumab refractory.

A total of 302 participants were randomised at a 1:1 ratio to receive either belantamab mafodotin plus PomDex, or bortezomib plus PomDex.

The primary endpoint is PFS as per an independent review committee. The key secondary endpoints include OS and MRD negativity rate as assessed by next-generation sequencing. Other secondary endpoints include ORR, DOR, safety and patient reported and quality of life outcomes.

Results from DREAMM-8 were first presented7 at the 2024 ASCO (Free ASCO Whitepaper) Annual Meeting and published in the New England Journal of Medicine.

About Blenrep
Blenrep is an antibody-drug conjugate comprising a humanised B-cell maturation antigen monoclonal antibody conjugated to the cytotoxic agent auristatin F via a non-cleavable linker. The drug linker technology is licensed from Seagen Inc.; the monoclonal antibody is produced using POTELLIGENT Technology licensed from BioWa Inc., a member of the Kyowa Kirin Group.

Refer to the Blenrep UK Summary of Product Characteristics8 for a full list of adverse events and the complete important safety information in the United Kingdom.