On February 18, 2024 Jacobio Pharma (1167.HK), a clinical-stage oncology company drugging the undruggable targets, reported that it has received approval of registrational phase III clinical trial of the combination therapy between its novel KRAS G12C inhibitor glecirasib and novel SHP2 inhibitor JAB-3312 (Press release, Jacobio Pharmaceuticals, FEB 18, 2024, View Source [SID1234640194]). JAB-3312 is the first SHP2 inhibitor entered into phase III study globally in combination with KRAS G12C inhibitor.

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This approved study in China is a randomized active controlled phase III trial design to evaluate the efficacy and safety of JAB-3312 in combination with glecirasib for first-line non-small cell lung cancer patients with KRAS G12C mutations. The control arm is the current standard treatment for first-line non-small cell lung cancer, which is the combination therapy of PD-1 antibody and chemotherapy.

Jacobio initiated clinical trials of SHP2 inhibitors in 2018. Data presented by Jacobio in an oral presentation at the 2023 European Society for Medical Oncology Annual Meeting (ESMO 2023) showed that among 129 patients with non-small cell lung cancer, 58 patients were first-line treatment patients (including 7 dose groups), ORR (objective response rate) was 65.5% (38/58), and the DCR (disease control rate) was 100%. Among them, in the dose group of 800 mg (once daily) glecirasib and 2 mg JAB-3312 (once daily for 1 week on, then 1 week off), the ORR was 86.7% (13/15). This clinical study is continuing to enroll patients.

The KRAS G12C inhibitors currently on the market have not been approved as first-line non-small cell lung cancer treatments for KRAS G12C mutations. Jacobio’s JAB-3312 and glecirasib are both oral formulations, and the combination therapy is also the first approved Phase III registration clinical trial for dual oral inhibitors in the first-line treatment of non-small cell lung cancer worldwide.

About JAB-3312

JAB-3312 is a highly selective SHP2 allosteric inhibitor with best-in-class potential. Jacobio is currently conducting clinical trials of JAB-3312 in monotherapy and combination therapies with glecirasib and other agents in China, the United States and Europe. The phase III study in combination with KRAS G12C inhibitor Glecirasib has been approved by China CDE in Feb 2024.

About Glecirasib

Glecirasib is a KRAS G12C inhibitor developed by Jacobio. A number of Phase I/II clinical trials of glecirasib are currently ongoing in China, the United States and Europe for patients with advanced solid tumors harboring KRAS G12C mutation. These include a pivotal clinical trial in NSCLC in China; a monotherapy study for STK11 co-mutated NSCLC in the front-line setting, and combination therapy trials with SHP2 inhibitor JAB-3312 in NSCLC and with Cetuximab in colorectal cancer.

On February 16, 2024 Sosei Group Corporation ("Sosei Heptares" or "the Company"; TSE: 4565), reported that at a meeting held on 15 February 2024, its Board of Directors resolved to change the corporate names of the Company and its subsidiaries and the location of the head office of the Company (Press release, Sosei Heptares, FEB 16, 2024, View Source [SID1234646049]). At the same meeting, the Board resolved to merge Idorsia Pharmaceuticals Japan Ltd ("IPJ") and Sosei Co. Ltd., both of which are whollyowned consolidated subsidiaries of the Company, and to change the corporate name of IPJ as the surviving company.

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The Board also resolved to submit a proposal on the "Partial Amendments to the Articles of Incorporation" to the 34th Ordinary General Meeting of Shareholders scheduled to be held on 27 March 2024 (details below).

1. Change of corporate names of the Company and its subsidiaries
(i) Reason for change
In July 2023, the Company acquired all the issued shares of IPJ and made it a wholly owned subsidiary with the strategic goal to expand the Company’s operations in Japan. As IPJ and Sosei Co. Ltd., also a wholly owned subsidiary of the Company, plan to merge as of the effective date 1 April 2024 as described in 3 below, the Company has decided to use the event to adopt a unified corporate brand and corporate name for the Group, including all subsidiaries.

The name "Nxera" derives from the words "Next" and "Era" to express the Company’s determination to be a leader in the next era of science and healthcare. "Nxera" will be a technology enabled pharma company that will challenge the status quo in its pursuit of better treatments for patients in need across multiple therapeutic areas.

(ii) New corporate names
Current name New name
Sosei Group Corporation Nxera Pharma Co., Ltd.
Idorsia Pharmaceuticals Japan Ltd Nxera Pharma Japan Co., Ltd.
Idorsia Pharmaceuticals Korea Co., Ltd Nxera Pharma Korea Co., Ltd.
Heptares Therapeutics Ltd. Nxera Pharma UK Limited

(iii) Date of change
1 April 2024 (planned)
* The change is subject to the approval of a partial amendment to the Articles of Incorporation at the Ordinary General Meeting of Shareholders.

2. Change of location of head office of the Company
(i) Reason for the change
Considering the merger between the subsidiaries as described in 3 below, the Company’s head office will be moved to the same location as the head office of IPJ (Minato-ku, Tokyo) to accelerate business integration and enhance operating efficiencies.

(ii) New location
9-7-2 Akasaka Minato-ku
Tokyo 107-0052
Japan

(iii) Date of change
1 April 2024 (planned)
* The change is subject to the approval of a partial amendment to the Articles of Incorporation at the Ordinary General Meeting of Shareholders.

3. Merger of wholly owned consolidated subsidiaries
(i) Purpose of the Merger
Since the acquisition of IPJ in July 2023, the Company has been pursuing integration synergies and decided to merge IPJ and Sosei Co. Ltd to accelerate business integration and enhance operating efficiencies.

(ii) Schedule of the Merger
15 February 2024 Approval of the Merger Agreement by the Board of Directors (the Company)
19 February 2024 Approval of the Merger Agreement by the Board of Directors (Sosei Co. Ltd)
20 February 2024 Approval of the Merger Agreement by the Board of Directors
20 February 2024 (planned) Execution of the Merger Agreement by the merging companies
27 March 2024 (planned) Approval of the Merger Agreement at the Meeting of Shareholders (the merging companies)
1 April 2024 (planned) Effective date of the Merger (Merger date)

(iii) Merger format
The Merger will be an absorption-type merger with IPJ as the surviving company and Sosei Co. Ltd. as the non-surviving company.

4. Partial amendments to the Articles of Incorporation
(i) Reason for the amendments
This is to amend Article 1 (Corporate Name) and Article 3 (Head Office) of the current Articles of Incorporation to make the change of corporate name of the Company mentioned in 1 and the change of the location of the Company mentioned in 2 above. This is also to amend the number of directors specified in Article 19 of the existing Articles of Incorporation from not more than ten (10) to not more than twelve (12) directors to allow for future flexibility to enhance the supervisory function of the Board as the Company grows.

Enquiries:
Sosei Heptares – Media and Investor Relations
Kentaro Tahara, VP Investor Relations and Corporate Strategy
Shinichiro Nishishita, VP Investor Relations, Head of Regulatory Disclosures
Maya Bennison, Communications Manager
+81 (0)3 5210 3399 | +44 (0)1223 949390 | [email protected]

On February 16, 2024 Orano reported its yearly results 2023 (Press release, Orano, FEB 16, 2024, View Source;orano-2023-annual-results.pdf?sfvrsn=2f2a892a_6 [SID1234643763])

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On February 16, 2024, AIM ImmunoTech Inc. (the "Company", "we", "us" or "our") reported to have entered into a Note Purchase Agreement (the "Note Purchase Agreement") with Streeterville Capital, LLC (the "Investor") and consummated the sale to such Investor of an unsecured Promissory Note (the "Note") with an original principal amount of $3,301,250 in a private placement (the "Private Placement") that closed on February 16, 2024 (Filing, 8-K, AIM ImmunoTech, FEB 16, 2024, View Source [SID1234640251]).

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The Note carries an original issuance discount of $781,250 and the Company agreed to pay $20,000 to the Investor to cover the Investor’s legal and administrative transaction costs, each of which were included in the original principal amount and deducted from the proceeds of the Note received by the Company which resulted in a purchase price received by the Company of $2,500,000.

The Note bears interest at ten percent (10%) per annum compounded daily. The maturity date of the Note is 24 months from the date of its issuance (the "Maturity Date").

We may prepay any or all of the outstanding balance under the Note prior to the Maturity Date, provided that if such prepayment covers less than the entire principal, fees and interest of the Note, the Company will remain subject to the remaining obligations under the Note.

The Note provides for customary events of default, including, among other things, the event of non-payment of principal, interest, fees or other amounts, a representation or warranty proving to have been incorrect when made, failure to perform or observe covenants within a specified period of time, a cross-default to certain other indebtedness of the Company, the bankruptcy or insolvency of the Company or of all or a substantial part of its property, monetary judgment defaults of a specified amount and other defaults resulting in liability of a specified amount. Upon the occurrence of an Event of Default, as defined in Section 4 of the Note, interest would accrue on the outstanding balance beginning on the date the applicable Event of Default occurred at an interest rate equal to the lesser of twenty-two percent (22%) or the maximum rate permitted under applicable law.

Beginning on the date that is six months after the Purchase Price Date, Investor shall have the right, exercisable at any time in its sole and absolute discretion, to redeem any amount of the Note up to $250,000 (such amount, the "Monthly Redemption Amount") per calendar month by providing written notice to the Company (each, a "Redemption Notice"); provided, however, that if the Investor does not exercise any Monthly Redemption Amount in its corresponding month then such Monthly Redemption Amount shall be available for the Investor to redeem in any future month in addition to such future month’s Redemption Amount. Upon receipt of any Monthly Redemption Notice, the Company shall pay the applicable Monthly Redemption Amount in cash to the Investor within three business days of the Company’s receipt of such Monthly Redemption Notice.

The foregoing is only a summary of the material terms of the Note Purchase Agreement and the Note, and does not purport to be a complete description of the rights and obligations of the parties thereunder. Furthermore, the foregoing is qualified in its entirety by reference to such documents, which are filed as Exhibit 10.1 and Exhibit 10.2, respectively, to this Current Report on Form 8-K and incorporated herein by reference.

On February 16, 2024 Immunome, Inc. ("Immunome") (Nasdaq: IMNM), a biotechnology company dedicated to developing first-in-class and best-in-class targeted cancer therapies, reported the closing of its underwritten public offering of 10,000,000 shares of its common stock, including the exercise in full by the underwriters of their option to purchase an additional 1,500,000 shares, at a price to the public of $20.00 per share (Press release, Immunome, FEB 16, 2024, View Source [SID1234640193]). The gross proceeds to Immunome from the offering, before deducting underwriting discounts and commissions and offering expenses, are $230.0 million. All of the shares in the offering were sold by Immunome.

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J.P. Morgan, TD Cowen, Leerink Partners and Guggenheim Securities acted as joint book-running managers for the offering. Wedbush PacGrow acted as lead manager for the offering.

The offering was made pursuant to a shelf registration statement on Form S-3 that was filed with the U.S. Securities and Exchange Commission (the "SEC") on February 13, 2024 and automatically became effective upon filing. A preliminary prospectus supplement and accompanying prospectus relating to the offering were filed with the SEC and are available for free on the SEC’s website located at View Source A final prospectus supplement and accompanying prospectus relating to the offering were filed with the SEC and are available for free on the SEC’s website located at View Source Copies of the final prospectus supplement and the accompanying prospectus relating to the offering may be obtained from: J.P. Morgan Securities LLC, Attention: Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by telephone at (866) 803-9204, or by email at [email protected]; Cowen and Company, LLC, 599 Lexington Avenue, New York, NY 10022, by email at [email protected] or by telephone at (833) 297-2926; Leerink Partners LLC, Syndicate Department, 53 State Street, 40th Floor, Boston, MA 02109, or by telephone at (800) 808-7525 ext. 6105, or by email at [email protected]; or Guggenheim Securities, LLC Attention: Equity Syndicate Department, 330 Madison Avenue, New York, NY 10017 or by telephone at (212) 518-9544, 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 registration or qualification under the securities laws of any such state or jurisdiction.