On August 9, 2024 Merck (NYSE: MRK), known as MSD outside of the United States and Canada, and Curon Biopharmaceutical (Curon), a privately held biotechnology company, reported that the companies have entered into a definitive agreement under which Merck, through a subsidiary, has agreed to acquire CN201, a novel investigational clinical-stage bispecific antibody for the treatment of B-cell associated diseases (Press release, Merck & Co, AUG 9, 2024, View Source [SID1234645677]).

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"We continue to identify opportunities to expand and diversify our pipeline," said Dr. Dean Y. Li, president, Merck Research Laboratories. "Early clinical data have provided robust evidence for the potential of CN201 to target and deplete circulating and tissue B cells with the potential to treat a range of malignant and autoimmune diseases."

Under the terms of the agreement, Merck through a subsidiary will acquire full global rights to CN201 for an upfront payment of $700 million in cash. Curon is also eligible to receive up to $600 million in milestone payments associated with the development and regulatory approval of CN201.

CN201 is currently being evaluated in Phase 1 and Phase 1b/2 clinical trials for the treatment of patients with relapsed or refractory non-Hodgkin’s lymphoma (NHL) and relapsed or refractory B-cell acute lymphocytic leukemia (ALL), respectively. Preliminary data suggest CN201 has activity in patients with relapsed or refractory B-cell hematologic malignancies and is well tolerated, with the potential to induce significant and sustained reductions in B-cell populations. Merck plans to evaluate CN201 as a treatment for B-cell malignancies as well as investigate its potential to provide a novel, scalable option for the treatment of autoimmune diseases.

"This agreement reflects the drive and dedication of the Curon team," said Zhihong Chen, president and chief executive officer, Curon. "As a pioneer in immuno-oncology, Merck is well positioned to build upon the work done to-date and investigate the wide-ranging, first-in-class potential of CN201."

Closing of the proposed transaction is subject to approval under the Hart-Scott-Rodino Antitrust Improvements Act and other customary conditions. The transaction is expected to close in the third quarter of 2024 and be accounted for as an asset acquisition. Merck expects to record a pre-tax charge of approximately $750 million (reflecting the upfront payment and other related costs), or approximately $0.28 per share, to be included in non-GAAP results in the quarter that the transaction closes. As a matter of policy, Merck provides updates to its financial outlook once each quarter and will provide an update to its full-year financial outlook when it reports third-quarter 2024 results.

Advisors
Hogan Lovells is serving as Merck’s legal advisor in this transaction. Centerview Partners LLC acted as financial advisor to Curon and Goodwin Procter LLP as the company’s legal advisor.

About CN201
CN201 is a novel CD3xCD19-targeting T-cell-engager bispecific antibody, designed to target B cells for elimination by T cells. CN201 is currently being evaluated in Phase 1 and Phase 1b/2 clinical trials for the treatment of relapsed or refractory non-Hodgkin’s lymphoma and relapsed or refractory acute lymphocytic leukemia, respectively.

On August 9, 2024 Kiromic BioPharma, Inc. (OTCQB: KRBP) ("Kiromic" or the "Company") reported interim results near the completion of Part 1 of its Deltacel-01 Phase 1 clinical trial. This trial is evaluating Deltacel (KB-GDT-01), the Company’s allogeneic, off-the-shelf, Gamma Delta T-cell (GDT) therapy, in patients with stage 4 metastatic non-small cell lung cancer (NSCLC) who have failed to respond to standard therapies (Press release, Kiromic, AUG 9, 2024, View Source [SID1234645676]).

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Based on data from the five patients evaluated for Progression-Free Survival (PFS) in the long-term follow-up, Kiromic has registered a PFS ranging from 2 to 8 months, with an average of 4.8 months.

No dose limiting toxicities (DLTs) have been reported by the clinical site for patients that have completed the full course of therapy. One patient was withdrawn from the study before completing the full course of therapy due to an adverse event related to a pre-existing co-morbidity and unrelated to Deltacel. Consequently, this subject could not be evaluated for PFS.

Additionally, the sixth and last patient in Part 1 of the Deltacel-01 study started treatment on August 6th.

"We are pleased to have completed enrollment in Part 1 of our clinical trial. The favorable results of our GDT therapy, particularly with respect to PFS, in the first two cohorts that comprise Part 1 underscore the potential of Deltacel to treat solid tumors, and we look forward to launching Part 2 of this study," said Pietro Bersani, Chief Executive Officer of Kiromic BioPharma.

Kiromic expects to obtain early safety and tolerability outcomes from the last enrolled patient in September and efficacy results in early October. Kiromic is on track to initiate Part 2 of Deltacel-01 in September.

About Deltacel-01

In Kiromic’s open-label Phase 1 clinical trial, titled "Phase 1 Trial Evaluating the Safety and Tolerability of Gamma Delta T Cell Infusions in Combination With Low Dose Radiotherapy in Subjects With Stage 4 Metastatic Non-Small Cell Lung Cancer" (NCT06069570), patients with stage 4 NSCLC will receive two intravenous infusions of Deltacel with four courses of low-dose, localized radiation over a 10-day period. The primary objective of the Deltacel-01 trial is to evaluate safety, while secondary measurements include objective response, progression-free survival, overall survival, time to progression, time to treatment response and disease control rates.

About Deltacel

Deltacel (KB-GDT-01) is an investigational gamma delta T-cell (GDT) therapy currently in the Deltacel-01 Phase 1 trial for the treatment of stage 4 metastatic NSCLC. An allogeneic product consisting of unmodified, donor-derived gamma delta T cells, Deltacel is the leading candidate in Kiromic’s GDT platform. Deltacel is designed to exploit the natural potency of GDT cells to target solid cancers, with an initial clinical focus on NSCLC, which represents about 80% to 85% of all lung cancer cases. Data from two preclinical studies demonstrated Deltacel’s favorable safety and efficacy profile when it was combined with low-dose radiation.

On August 9, 2024, INmune Bio Inc. (the "Company"), reported to have entered into an Amended and Restated At-The-Market Sales Agreement (the "Sales Agreement") with RBC Capital Markets, LLC and BTIG, LLC as sales agents pursuant to which the Company may offer and sell, from time to time, in its sole discretion, shares of its common stock, having an aggregate offering price of up to $75,000,000, subject to certain limitations on the amount of common stock that may be offered and sold by the Company set forth in the Sales Agreement (Filing, 8-K, INmune Bio, AUG 9, 2024, View Source [SID1234645675]). The Company is not obligated to make any sales of common stock under the Sales Agreement and any determination by the Company to do so will be dependent, among other things, on market conditions and the Company’s capital raising needs.

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Any shares offered and sold in the at-the-market offering will be issued pursuant to the registration statement on Form S-3 (File No. 333-279036), filed with the Securities and Exchange Commission (the "SEC"), on May 1, 2024, and declared effective on August 7, 2024, and the prospectus supplement relating to the at-the-market offering filed with the SEC on August 9, 2024, and any applicable additional prospectus supplements related to the at-the-market offering that form a part of the registration statement.

The sales agents may sell the shares of common stock by any method deemed to be an "at the market offering" as defined in Rule 415(a)(4) of the Securities Act of 1933, as amended, including sales made through The Nasdaq Capital Market ("Nasdaq"), or any other trading market for the common stock, sales made to or through a market maker other than on an exchange or through an electronic communications network, or in negotiated transactions pursuant to terms set forth in a placement notice delivered by the Company to the sales agents under the Sales Agreement. Upon delivery of a placement notice and subject to the terms and conditions of the Sales Agreement, the sales agents will use commercially reasonable efforts, consistent with its normal trading and sales practices, applicable state and federal law, rules and regulations, and the rules of Nasdaq, to sell the shares from time to time based upon the Company’s instructions, including any price, time or size limits specified by the Company. The sales agents are not obligated to purchase any shares of common stock on a principal basis pursuant to the Sales Agreement.

The Company will pay the sales agents a commission equal to 3.0% of the gross sales proceeds of any shares sold through the sales agents under the Sales Agreement, and also has provided the sales agents with customary indemnification and contribution rights. The Company also will reimburse the sales agents for certain specified expenses in connection with entering into the Sales Agreement, as well as certain specified expenses on a quarterly basis. The Sales Agreement contains customary representations and warranties and conditions to the placements of the shares pursuant thereto, obligations to sell shares under the Sales Agreement are subject to satisfaction of certain conditions, including customary closing conditions.

The foregoing description of the Sales Agreement is not complete and is qualified in its entirety by reference to the full text of the Sales Agreement, a copy of which is filed herewith as Exhibit 1.1 to this Current Report on Form 8-K and is incorporated herein by reference. A copy of the opinion of Sichenzia Ross Ference Carmel LLP relating to the legality of the issuance and sale of the shares in the at-the-market offering 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 the securities discussed herein, nor shall there be any offer, solicitation, or sale of the 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.

On August 9, 2024 Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CANF), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address oncological and inflammatory diseases, reported the entry into a definitive agreement for the immediate exercise of certain outstanding warrants to purchase up to an aggregate of 2,857,143 American Depositary Shares (ADSs), having an exercise price of $1.75 per ADS, issued by Can-Fite in January 2023 and November 2023 (Press release, Can-Fite BioPharma, AUG 9, 2024, View Source [SID1234645674]). The ADSs representing ordinary shares issuable upon exercise of the warrants are registered pursuant to effective registration statements on Form F-3 (File No. 333-276000) and Form F-1 (File No. 333-269485). The closing of the offering is expected to occur on or about August 12, 2024, subject to satisfaction of customary closing conditions.

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

In consideration for the immediate exercise of the warrants for cash, Can-Fite will issue new unregistered warrants to purchase up to 5,714,286 ADSs. The new warrants will have an exercise price of $2.25 per ADS, will be immediately exercisable until the five-year anniversary from the date of issuance with respect to 2,987,012 new warrants and the twenty-month anniversary from the date of issuance with respect to 2,727,274 new warrants.

The gross proceeds to Can-Fite from the exercise of the warrants are expected to be approximately $5.0 million, prior to deducting placement agent fees and offering expenses. The Company intends to use the net proceeds for funding research and development and clinical trials and for other working capital and general corporate purposes.

The new warrants described above were offered in a private placement pursuant to an applicable exemption from the registration requirements of the Securities Act of 1933, as amended (the "1933 Act"), and, along with the ADSs issuable upon exercise, have not been registered under the 1933 Act, and may not be offered or sold in the United States absent registration with the Securities and Exchange Commission ("SEC") or an applicable exemption from such registration requirements. Can-Fite has agreed to file a registration statement with the SEC covering the resale of the shares of ADSs issuable upon exercise of the new warrants.

This press release does not constitute an offer to sell or a solicitation of an offer to buy the securities in this offering, nor shall there be any sale of these securities in any state or other 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 other jurisdiction.

On August 8, 2024 Orion reported half-year financial report (Presentation, Orion, AUG 8, 2024, View Source [SID1234646716]).

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