On December 20, 2024 IO Biotech (Nasdaq: IOBT), a clinical-stage biopharmaceutical company developing novel, immune-modulating, off-the-shelf therapeutic cancer vaccines reported that it has entered into a loan facility of up to €57.5 million from the European Investment Bank (EIB), the long-term lending institution of the European Union owned by its Member States (Press release, IO Biotech, DEC 20, 2024, View Source [SID1234649238]). The debt facility includes three committed tranches totaling up to €37.5 million, which will become available if the company satisfies certain conditions, and one uncommitted accordion tranche of €20 million. The company expects the first two tranches to be available for disbursement in the first quarter of 2025.

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Amy Sullivan, Chief Financial Officer of IO Biotech, commented, "The support from the EIB, which is provided on favorable terms, will help fund the continued development and pre-commercialization of IO102-IO103 and other therapeutic cancer vaccine candidates generated from our T-Win platform. We expect that the capital drawn from the three committed tranches of the EIB debt facility will extend our cash runway into the second quarter of 2026."

The loan facility is unsecured has no minimum cash covenants and consists of three committed tranches of €10.0 million (Tranche A), €12.5 million (Tranche B), and €15.0 million (Tranche C) totaling €37.5 million, and one uncommitted accordion tranche of €20.0 million. Each committed tranche will become available if the company satisfies certain conditions precedent. The company expects funds from Tranches A and B to be available in the first quarter of 2025. The company has 36 months to satisfy the conditions for Tranche C, which include raising an additional $50 million in cash and submitting an application for marketing authorization for IO102-IO103 in the U.S. or the EU. In addition, as a condition for disbursement of each Tranche of the loan facility, the company has agreed to issue to the EIB warrants to purchase a number of shares of the company’s common stock determined by a formula set forth in a warrant issuance agreement. Each tranche has a maturity of 6 years from its disbursement. The loan is structured with capitalized interest and payment deferred to maturity of each tranche.

Van Lanschot Kempen served as financial advisor to the company and Kromann Reumert and Sidley Austin LLP acted as legal counsel to the company.

About IO102-IO103

IO102-IO103 is an investigational, immune-modulatory, off-the-shelf therapeutic cancer vaccine designed to kill both tumor cells and immune-suppressive cells in the tumor microenvironment (TME) by stimulating activation and expansion of T cells against indoleamine 2,3-dioxygenase (IDO1) positive and/or programmed death-ligand 1 (PD-L1) positive cells. Based on positive Phase 1/2 first line metastatic melanoma data, IO102-IO103, in combination with pembrolizumab, has been granted a Breakthrough Therapy Designation for the treatment of advanced melanoma by the US Food and Drug Administration. The company is currently conducting a pivotal Phase 3 trial (IOB-013/KN-D18; NCT05155254) investigating IO102-IO103 in combination with pembrolizumab versus pembrolizumab alone in patients with advanced melanoma, a Phase 2 basket trial (IOB-022/KN-D38; NCT05077709) investigating IO102-IO103 in combination with pembrolizumab as first line treatment in patients with advanced solid tumors, and a Phase 2 basket trial (IOB-032/PN-E40; NCT05280314) investigating IO102-IO103 in combination with pembrolizumab as neo-adjuvant/adjuvant treatment of patients with solid tumors.

The clinical trials are sponsored by IO Biotech and conducted in collaboration with Merck, which is supplying pembrolizumab. IO Biotech maintains global commercial rights to IO102-IO103.

KEYTRUDA is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.

On December 20, 2024 Merck (NYSE: MRK), known as MSD outside of the United States and Canada, reported the closing of the exclusive global license agreement for LM-299, a novel investigational PD-1/VEGF bispecific antibody, from LaNova Medicines Ltd (Press release, Merck & Co, DEC 20, 2024, View Source [SID1234649239]). As previously announced, Merck will develop, manufacture and commercialize LM-299.

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Merck will record a pre-tax charge relating to the upfront payment of $588 million, or approximately $0.18 per share, in the company’s fourth quarter 2024 GAAP and non-GAAP results. LaNova is also eligible to receive up to $2.7 billion in milestone payments associated with the technology transfer, development, regulatory approval and commercialization of LM-299 across multiple indications, including $300 million upon technology transfer anticipated to be completed in 2025.

About LM-299

LM-299 is an investigational bispecific antibody targeting both programmed cell death protein-1 (PD-1) and vascular endothelial growth factor (VEGF). This innovative therapeutic approach is designed to inhibit both PD-1/PD-L1 and VEGF/VEGFR receptor signaling pathways releasing a key immune checkpoint while also inhibiting the production of new blood vessels (angiogenesis). LM-299 has a differentiated molecular design, comprising an anti-VEGF antibody linked to two C-terminal single domain anti-PD-1 antibodies. A Phase 1 clinical trial for LM-299 is currently enrolling patients in China.

On December 20, 2024 Merck (NYSE: MRK), known as MSD outside of the United States and Canada, reported the closing of the exclusive global license agreement for LM-299, a novel investigational PD-1/VEGF bispecific antibody, from LaNova Medicines Ltd (Press release, Merck & Co, DEC 20, 2024, View Source [SID1234649239]). As previously announced, Merck will develop, manufacture and commercialize LM-299.

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Merck will record a pre-tax charge relating to the upfront payment of $588 million, or approximately $0.18 per share, in the company’s fourth quarter 2024 GAAP and non-GAAP results. LaNova is also eligible to receive up to $2.7 billion in milestone payments associated with the technology transfer, development, regulatory approval and commercialization of LM-299 across multiple indications, including $300 million upon technology transfer anticipated to be completed in 2025.

About LM-299

LM-299 is an investigational bispecific antibody targeting both programmed cell death protein-1 (PD-1) and vascular endothelial growth factor (VEGF). This innovative therapeutic approach is designed to inhibit both PD-1/PD-L1 and VEGF/VEGFR receptor signaling pathways releasing a key immune checkpoint while also inhibiting the production of new blood vessels (angiogenesis). LM-299 has a differentiated molecular design, comprising an anti-VEGF antibody linked to two C-terminal single domain anti-PD-1 antibodies. A Phase 1 clinical trial for LM-299 is currently enrolling patients in China.

On December 20, 2024, Kronos Bio, Inc. (the "Company") reported to have entered into a Transition Agreement and Mutual General Release (the "Transition Agreement") with Genentech, Inc. and F. Hoffmann-La Roche Ltd (together, "Genentech"), pursuant to which the Company and Genentech agreed to void and cancel all of the parties’ respective rights and obligations under the Collaboration and License Agreement between the parties dated January 6, 2023 (the "Collaboration Agreement") (Filing, Kronos Bio, DEC 20, 2024, View Source [SID1234649329]). Pursuant to the Transition Agreement, the Company will transfer and assign to Genentech all small molecule compounds, materials, data, and intellectual property generated by the Company in connection with the two discovery research programs ("Program Materials") conducted by the Company under the Collaboration Agreement, but excluding the Company’s proprietary drug discovery platform. The Company also granted to Genentech a perpetual, irrevocable, non-exclusive and fully paid up license under certain related intellectual property owned or controlled by the Company that is necessary or reasonably useful to exploit the Program Materials. The Transition Agreement has the effect of terminating the Collaboration Agreement, and provides for a general release of any actual or potential claims between the Company and Genentech relating thereto. In addition, the Transition Agreement cancels and voids any and all downstream payment obligations between the parties relating to or arising from the Collaboration Agreement or any programs or compounds arising thereunder. The Company has made a one-time payment in connection with the termination of the Collaboration Agreement, which is intended to support the transition of all activities under the Collaboration Agreement to Genentech.

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The foregoing is a summary description of certain terms of the Transition Agreement and does not purport to be complete, and is qualified in its entirety by reference to the full text of the Transition Agreement to be filed, with confidential terms redacted, as an exhibit to the Company’s Annual Report on Form 10-K for the year ending December 31, 2024.

On December 20, 2024 Monopar Therapeutics Inc. (Nasdaq: MNPR) ("Monopar" or the "Company"), a clinical-stage biotechnology company focused on developing innovative treatments for patients with unmet medical needs, reported the pricing of an underwritten registered offering of 798,655 shares of its common stock at an offering price of $23.79 per share (Press release, Monopar Therapeutics, DEC 20, 2024, View Source [SID1234649240]). In addition to the shares sold in the registered offering, Monopar announced the concurrent pricing of a private placement of pre-funded warrants to purchase 882,761 shares of common stock at a purchase price of $23.789 per pre-funded warrant, which represents the per share offering price for the common stock less the $0.001 per share exercise price for each pre-funded warrant. The gross proceeds to Monopar from the registered offering and private placement, before deducting the underwriting discounts and commissions and estimated offering expenses, are expected to be $40 million. The offering is expected to close on or about December 23, 2024, subject to customary closing conditions.

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Monopar intends to use the net proceeds from the offering for general corporate purposes, which may include research and development expenditures, clinical trial expenditures, manufacture and supply of product, and working capital.

RA Capital Management, Janus Henderson Investors, Adage Capital Partners LP and ADAR1 Capital Management participated in the offering.

Piper Sandler & Co. is acting as the sole book-running manager for the offering.

The securities in the registered offering are being offered and sold pursuant to a "shelf" registration statement on Form S-3 (File No. 333-268935), including a base prospectus, filed with the U.S. Securities and Exchange Commission (the "SEC") on December 21, 2022, and declared effective on January 4, 2023. A prospectus supplement and accompanying prospectus describing the terms of the registered offering will be filed with the SEC and will be available on its website at www.sec.gov. Copies of the prospectus supplement and the accompanying prospectus relating to the registered offering, when available, may also be obtained by contacting Piper Sandler & Co. by mail at Attention: Prospectus Department, 800 Nicollet Mall, J12S03, Minneapolis, MN 55402, by telephone at (800) 747-3924 or by email at [email protected].

This press release shall not constitute an offer to sell or the solicitation of an offer to buy any of the securities described herein, 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.