On October 31, 2023 (the "Fourth Amendment Effective Date"), Akebia Therapeutics, Inc. (the "Company"), BioPharma Credit PLC (the "Collateral Agent"), BPCR Limited Partnership (as a "Lender") and BioPharma Credit Investments V (Master) LP (as a "Lender") reported to have entered into the Fourth Amendment to Loan Agreement (the "Fourth Amendment"), which amends certain provisions of the Loan Agreement, dated November 11, 2019, as amended by the First Amendment and Waiver, dated February 18, 2022, the Second Amendment and Waiver, dated July 15, 2022 and the Third Amendment dated June 30, 2023, between the parties (as amended, the "Loan Agreement") (Filing, 8-K, Akebia, OCT 31, 2023, View Source [SID1234636723]). As of October 31, 2023, there was $35.0 million of principal outstanding under the Term Loans (as defined in the Loan Agreement).

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The Fourth Amendment extends the maturity date of each Term Loan from November 11, 2024 to March 31, 2025 (the "New Maturity Date"). The Fourth Amendment also delays the payment of additional principal of each Term Loan until October 31, 2024, at which time the Company will make monthly payments of principal; provided that, if certain pre-specified events occur, the Company will (a) make payments of principal of such Term Loans commencing on the Payment Date (as defined in the Loan Agreement) immediately following the occurrence of such event and continuing on a quarterly basis on each Payment Date thereafter through the New Maturity Date and (b) repay, on a specified date on or after July 1, 2024, all unpaid principal that would have been due and payable during the period commencing on the Payment Date immediately following the Fourth Amendment Effective Date and ending on the Payment Date immediately following such date (including all accrued and unpaid interest thereon, if any), as if the Company had been required to make equal quarterly payments of principal of such Term Loans commencing on the Payment Date immediately following the Fourth Amendment Effective Date.

The Term Loans bear interest through maturity at a variable rate based upon the three-month Secured Overnight Financing Rate ("SOFR") rate, plus a SOFR adjustment of 0.3%, plus 7.50%. Prior to the Fourth Amendment, the three-month SOFR rate was subject to a 3.35% cap (the "SOFR Cap"). The Fourth Amendment removed the SOFR Cap as of the Fourth Amendment Effective Date. The SOFR rate as of the Fourth Amendment Effective Date was 5.35%.

The foregoing description of the Fourth Amendment does not purport to be complete, and is qualified in its entirety by reference to the Fourth Amendment, a copy of which the Company expects to file with its Annual Report on Form 10-K for the year ending December 31, 2023.

As previously disclosed, on May 22, 2023, CohBar, Inc., a Delaware corporation ("CohBar"), Morphogenesis, Inc., a Delaware corporation ("Morphogenesis"), and Chimera MergeCo, Inc., a Delaware corporation and wholly owned subsidiary of CohBar ("Merger Sub"), reported to have entered into an Agreement and Plan of Merger (as amended by the First Amendment thereto dated as of August 28, 2023, the "Merger Agreement"), which provided that, among other things, and subject to the satisfaction or waiver of certain conditions set forth in the Merger Agreement, Merger Sub would merge with and into Morphogenesis, with Morphogenesis surviving as a wholly owned subsidiary of CohBar (the "Merger") (Filing, 8-K, CohBar, OCT 31, 2023, View Source [SID1234636628]). The Merger Agreement is filed as Annex A to CohBar’s definitive proxy statement/prospectus filed with the Securities and Exchange Commission on September 12, 2023 (the "Proxy Statement/Prospectus"). The material terms of the Merger Agreement were described in the section titled "The Merger Agreement" of the Proxy Statement/Prospectus and are incorporated by reference herein.

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In connection with the Merger Agreement, CohBar filed an initial listing application for the common stock of the combined company to be listed on The Nasdaq Capital Market ("Nasdaq"). It is a condition of the closing of the Merger under the Merger Agreement that the initial listing application with Nasdaq shall have been approved by Nasdaq. On October 30, 2023, CohBar and Morphogenesis received oral guidance from Nasdaq on the initial listing application indicating that the structure proposed by the parties would not receive approval. As a result, CohBar and Morphogenesis proceeded to discuss the oral guidance from Nasdaq over the course of October 30 and 31, 2023. As of October 31, 2023, CohBar had not received approval of the initial listing application from Nasdaq.

On October 31, 2023, the board of directors of CohBar, in consultation with management and after careful consideration, determined that there was not a viable path forward to consummate the Merger primarily due to the oral guidance received from Nasdaq. On November 1, 2023, CohBar received a termination notice from Morphogenesis pursuant to Section 8.1(b) of the Merger Agreement, effective November 1, 2023, and the Merger Agreement was terminated in accordance with its terms. Section 8.1(b) of the Merger Agreement provides that the Merger Agreement may be terminated by CohBar or Morphogenesis if the Merger has not been consummated by October 31, 2023.

CohBar intends to commence the process of liquidating and dissolving itself in accordance with its organizational documents and applicable law. As of September 30, 2023, CohBar had cash, cash equivalents and investments of approximately $9.1 million (unaudited) and accrued liabilities of approximately $1.5 million (unaudited). Due to anticipated but as yet unquantifiable expenses associated with the liquidation and dissolution process, an estimate of the amounts expected to be available to return to CohBar’s public stockholders, if any, cannot be provided at this time.

On October 31, 2023 Palleon Pharmaceuticals, a clinical-stage company pioneering glyco-immunology drug development to treat cancer and inflammatory diseases, reported that it will present new findings from a study leveraging its HYDRA platform that suggests a link between stromal hypersialylation and immunosuppression activity within the colorectal tumor microenvironment at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s 38th Annual Meeting taking place in San Diego from November 1-5, 2023 (Press release, Palleon Pharmaceuticals, OCT 31, 2023, View Source [SID1234636603]).

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The poster will include the specifics of the study which was conducted in collaboration with the University of Galway. The study revealed that both tumor cells and tumor-associated stromal cells are hypersialylated in the colorectal tumor environment. Additionally, removing sialic acids from stromal cells using an engineered human sialidase (EAGLE) reversed stromal cell-mediated immunosuppression in the co-culture of T cells and cancer-associated fibroblasts derived from colon cancer patients.

Details of the poster presentation are as follows:

Presentation Type: Poster Presentation (Abstract: #1438)

Title: Stromal hypersialylation within colorectal tumors contributes to immunosuppression of T cell adaptive immunity in the tumor microenvironment

Session: Poster Hall Session

Timing: November 4, 2023, 9:00 a.m. – 8:30 p.m. PDT

Location: Exhibit Halls A and B1 – San Diego Convention Center

The poster will appear on Palleon Pharmaceuticals’ website following the presentation.

On October 31, 2023 BostonGene, a leading provider of AI-driven molecular and immune profiling solutions, reported its abstract has been accepted for poster presentation at the 2023 CTOS Annual Meeting being held November 1-4, 2023, in Dublin, Ireland (Press release, BostonGene, OCT 31, 2023, View Source [SID1234636602]).

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Details of the presentation are as follows:

Abstract number: P 420
Title: Comprehensive Molecular Profiling and Tumor Microenvironment Characteristics of Radiation-Induced Sarcoma
Presenter: Lev Bedniagin, MD, BostonGene
Category: Sarcoma Biology & ‘Omics
Date and time: Thursday, November 2, 2023 | 5:30 PM – 6:30 PM

A late-onset complication of radiotherapy, radiation-induced sarcoma (RIS), is a rare tumor associated with chemotherapy resistance and poor prognosis. Although immune checkpoint inhibitors (ICIs) are recommended for several soft tissue tumors, their efficacy has not been demonstrated in RIS. BostonGene Tumor PortraitTM testing, including whole exome sequencing (WES) and RNA-seq was performed to characterize the tumor microenvironment (TME) composition and identify genomic drivers of RIS to guide therapeutic decision-making. Over 50% of RIS patients had an IE TME subtype, which indicated the probability of a favorable response to ICI.

Click here to learn more about 2023 CTOS Annual Meeting.

On October 31, 2023 Ionpath, a pioneer in high-plex spatial proteomics, reported the launch of its new service and data analysis tools for immuno-oncology applications in basic, translational, and clinical research (Press release, IONpath, OCT 31, 2023, View Source [SID1234636601]). The service and analysis tools will be presented at the annual meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper), taking place November 1-5 in San Diego, in the Ionpath exhibit hall booth (#1107).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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Ionpath’s single-cell, spatial proteomics service utilizes its multiplexed ion beam imaging (MIBI) technology, which uses mass spectrometry to query dozens of proteins with unmatched sensitivity and true subcellular resolution. The service offering, known as MIBIplus, launches with a human immuno-oncology panel that enables the detection of more than 40 relevant cell types in a single scan for a more complete view of the biological mechanisms in the tissue microenvironment affecting drug response, cancer progression, and more. Tissue samples are processed and run at Ionpath, and data is analyzed and returned to clients through a standardized report of actionable information. Ionpath’s new user-friendly analysis tool, MIBIsight, allows for iteration and customization of the standardized report by the customer to answer specific research questions.

"We’ve heard customers express high interest in a way to convert raw image data into actionable insights," said David Summa, CEO of Ionpath. "In response, we are launching a new service offering, with user-friendly bioinformatic tools enabling scientists to take control of their data interpretation."

The MIBIplus immuno-oncology service is now available for human tissue samples, and will soon be available for mouse samples as well. Projects can be completed from start to finish in two months or less. Special introductory pricing is available for new clients interested in learning how MIBI technology works with their samples through pilot projects.

To learn more about the immuno-oncology service, please visit our SITC (Free SITC Whitepaper) booth (#1107) or our website: View Source