On December 20, 2021 Immix Biopharma, Inc. (Nasdaq: IMMX) ("ImmixBio" or the "Company"), a biopharmaceutical company pioneering Tissue Specific Therapeutics (TSTx)TM targeting oncology and immuno-dysregulated diseases, reported the closing of its initial public offering of 4,200,000 shares of its common stock at a public offering price of $5.00 per share, for gross proceeds of $21,000,000, before deducting underwriting discounts, commissions and offering expenses (Press release, Immix Biopharma, DEC 20, 2021, View Source [SID1234597457]). In addition, the Company has granted the underwriters a 45-day option to purchase up to an additional 630,000 shares of common stock at the initial public offering price, less the underwriting discount, to cover over-allotments.

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The shares began trading on the Nasdaq Capital Market on December 16, 2021 under the ticker symbol "IMMX."

ThinkEquity acted as sole book-running manager for the offering.

The Company intends to use the net proceeds from the offering to fund a planned IMX-110 Phase 2a clinical trial in soft tissue sarcoma and IMX-110 + tislelizumab Phase 1b combination trial, for IND-enabling studies for IMX-111 (colorectal cancer) and IMX-120 (inflammatory bowel disease), and for working capital and other general corporate purposes.

A registration statement on Form S-1 (file No. 333-259591) relating to the shares was filed with the Securities and Exchange Commission (the "SEC") and become effective on December 15, 2021. The offering was made only by means of a prospectus. Copies of the final prospectus may be obtained on the SEC’s website, www.sec.gov, or by contacting ThinkEquity, 17 State Street, 22nd Floor, New York, New York 10004, by telephone at (877) 436-3673 or by email at [email protected].

This press release shall not constitute an offer to sell, or a solicitation of an offer to buy these securities, 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.

On December 20, 2021 EMD Serono, the Healthcare business sector of Merck KGaA, Darmstadt, Germany, in the U.S. and Canada, reported a strategically focused expansion of its neurology pipeline with the acquisition of the rights to develop cladribine for the treatment of generalized myasthenia gravis (gMG) and neuromyelitis optica spectrum disorder (NMOSD) (Press release, EMD Serono, DEC 20, 2021, View Source [SID1234597486]). The company entered into an agreement to secure the global rights by acquiring Chord Therapeutics, a Swiss-based biotech company focused on rare neuroinflammatory diseases.

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"Cladribine has a unique mechanism of action which is relevant in antibody-mediated disease such as NMOSD and gMG. In exploratory studies, cladribine demonstrated promising results in these diseases. These data have prompted us to initiate further development with cladribine in gMG and NMOSD to potentially bring a new therapeutic option to patients and expand our portfolio in this area," said Danny Bar-Zohar, MD, Head of Global Development for the biopharma business of Merck KGaA, Darmstadt, Germany.

Cladribine is a well characterized molecule that has been extensively studied across MS and oncologic disorders and has shown promising results in exploratory studies in gMG and NMOSD. EMD Serono plans to leverage its existing capabilities to further develop an oral cladribine product tailored specifically for these indications. The transaction is expected to be closed in early 2022 after satisfactory completion of customary closing conditions.

Generalized myasthenia gravis is a disease in which patients experience weakness in ocular, limb, and respiratory muscles and that has a significant impact on Quality of Life. It is estimated that 700,000 people around the world are living with gMG. NMOSD, also known as Devic´s disease, is an autoimmune disease, often misdiagnosed as MS due to similar symptoms. NMOSD is estimated to impact 200,000 people around the world.

On December 20, 2021 Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE:CFBI), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address inflammatory, cancer and liver diseases, reported the agreement by an healthcare-focused institutional investor to exercise certain warrants to purchase up to an aggregate of 150,000,000 ordinary shares represented by 5,000,000 American Depositary Shares (ADSs) having an exercise price of $2.00 per ADS issued by Can-Fite in August 2021, at an exercise price of $2.00 per ADSs (Press release, Can-Fite BioPharma, DEC 20, 2021, View Source [SID1234597540]).

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The ADSs and the ordinary shares issuable upon exercise of the warrants are registered pursuant to a registration statement on Form F-1 (File No. 333-259085) which became effective by the Securities and Exchange Commission (SEC) on August 31, 2021. The gross proceeds to Can-Fite from the exercise of the warrants are expected to be $10.0 million, prior to deducting placement agent fees and offering expenses.

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, the exercising holder will be issued new unregistered warrants to purchase ordinary shares represented by ADSs in a private placement pursuant to Section 4(a)(2) of the Securities Act of 1933, as amended (the "1933 Act"). The warrants will be exercisable into an aggregate of up to 180,000,000 ordinary shares represented by 6,000,000 ADS, at an exercise price of $2.00 per ADS and have a term of exercise equal to five (5) years following the effectiveness of an initial resale registration statement registering the ADSs issuable upon the exercise of the warrants.

Can-Fite intends to use the net proceeds from the offering for working capital including for the launch of the Phase II study in NASH and Phase III liver cancer study as well as other 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 1933 Act and, along with the ADSs or the ordinary shares issuable upon their exercise, have not been registered under the 1933 Act, and may not be offered or sold in the United States absent registration with the SEC or an applicable exemption from such registration requirements. The securities were offered only to accredited investors. The Company has agreed to file a registration statement with the SEC covering the resale of the ADSs and ordinary shares of issuable upon exercise of the new warrants.

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.

On December 20, 2021, Coeptis Pharmaceuticals, Inc. ("Coeptis"), our wholly-owned subsidiary, reported that it entered into amendment No. 1 to that certain promissory note in the original principal amount of $2,300,000 related to CD038-GEAR-NK-Auto to (i) make a payment of $550,000 towards the outstanding principal amount, (ii) extend the maturity date for the outstanding balance from December 31, 2021 to March 31, 2022 and increase the minimum percentage ownership from 20% to 25% (Filing, 8-K, Coeptis Pharmaceuticals, DEC 20, 2021, View Source [SID1234597761]). Pursuant to the amendment, if the promissory note is timely paid by March 31, 2022, Coeptis will maintain its 50% ownership interest in the CD038-GEAR-NK(Auto) product candidate, and if the promissory note is not timely paid by March 31, 2022, Coeptis’ ownership interest in such assets will automatically be reduced to 25% and the promissory note will be automatically cancelled and will no longer be due or payable. The original promissory note was described in our Current Report on Form 8-K that was filed with the SEC on August 19, 2021.

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Simultaneous with the entering into of such amendment, Coeptis paid in full the outstanding amount due under that certain promissory note in the original principal amount of $950,000 related to CD038-SNP-DIAG. Upon the making of such payment, Coeptis secured its 50% ownership of the CD038-SNP-DIAG product candidate.

In addition, on December 20, 2021, we and VyGen-Bio, Inc. entered into a long form Co-development and Steering Committee Agreement, which agreement governs the relationship between us and VyGen-Bio related to development efforts and revenue sharing for both CD038-GEAR-NK(Auto) and CD038-SNP-DIAG product candidates. A copy of the Co-development and Steering Committee Agreement attached at Exhibits 4.1 to this Current Report on Form 8-K.

On December 20, 2021 FibroGen, Inc. (Nasdaq: FGEN), a leading biopharmaceutical company discovering, developing, and commercializing first-in-class therapeutics, and HiFiBiO Therapeutics, a private, multinational clinical-stage biotherapeutics company with expertise in immune modulation and single cell science, reported an extension of their partnership with FibroGen’s exercise of an exclusive license option for HiFiBiO’s anti-CCR8 monoclonal antibody program (HFB1011) (Press release, HiFiBiO Therapeutics, DEC 20, 2021, View Source [SID1234597440]).

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"We are pleased to add the HiFiBiO CCR8 program and the HFB101110 molecule to our preclinical development pipeline," said John Hunter, Chief Scientific Officer, FibroGen. "With this addition in the immuno-oncology space, we have the exciting opportunity to further expand our early development pipeline."

"We are excited to strengthen our FibroGen partnership with the license of HFB1011, a unique program targeting CCR8, a GPCR majorly expressed on regulatory T cells in the tumor microenvironment. Our antibody, identified by using our single B cell cloning platform, is another demonstration of our Drug Intelligent Science (DIS) approach for novel drug discovery and development. Together with the Galectin-9 program (HFB2009), we expand our collaboration with FibroGen to develop transformative medicines in immuno-oncology", said Liang Schweizer, Ph.D., Chief Executive Officer, HiFiBiO.

Under the terms of the agreement, HiFiBiO will receive a $35 million upfront payment from FibroGen in addition to potential clinical, regulatory, and commercial milestones. HiFiBiO will also be eligible to receive royalties based upon net sales.

FibroGen will have the sole right to develop all products in the CCR8 program worldwide. The development candidate is expected to enter clinical development in 2023.

About CCR8

CCR8 is a GPCR with prevalent and highly specific expression on immunosuppressive tumor infiltrating regulatory T cells (Tregs) across different tumor types. Stimulation of CCR8 by its ligand results in proliferation of Tregs and immune-suppression in the tumor microenvironment. Targeting CCR8 with an antibody able to mediate cell killing through antibody-dependent cellular cytotoxicity (ADCC) offers the potential to selectively deplete highly immunosuppressive Tregs in the tumor microenvironment and promote anti-tumor immunity.