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Summary of Consolidated Financial Results for the Second Quarter of the Year Ending March 31, 2024

On October 31, 2023 Sumitomo Dainippon Pharma reported the summary of Consolidated Financial Results for the Second Quarter of the Year Ending March 31, 2024 (Press release, Sumitomo Dainippon Pharma, OCT 31, 2023, View Source [SID1234638476]).

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Outpace Bio to Present New Data on Tumor-restricted IL-12 Designed Leveraging OutSmart Technology to Enhance Solid Tumor T Cell Therapies at SITC 2023

On October 31, 2023 Outpace Bio, a cell therapy company that is solving the major barriers to curing solid tumors with AI-powered protein design, reported it will present the latest advancements to its OutSmartTM platform during a poster presentation at the 38th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) being held from November 1-5, 2023 in San Diego, CA (Press release, Outpace Bio, OCT 31, 2023, View Source [SID1234637782]).

Overcoming major barriers to efficacy & safety in solid tumors with OutSmartTM

Cancer cells produce signaling proteins that turn off the immune response, creating a suppressive tumor microenvironment (TME) that allows cancer to grow and spread. Pro-inflammatory cytokines could overcome this barrier to effective cancer immunotherapies but pose a significant safety risk to patients when delivered systemically given their potency.

The forthcoming data showcase the most recent advancements in Outpace’s groundbreaking OutSmartTM platform technology, which enables exquisite regulation of cytokine signaling within the TME to surmount this significant hurdle to the success of engineered cell therapy for solid tumors. OutSmartTM cytokines orchestrate a productive immune response at the tumor through highly localized activity that stimulates both the engineered cell therapy as well as endogenous immune cells.

New data on context-dependent, localized IL-12 activity designed leveraging OutSmartTM technology

The presentation highlights an innovative tumor-restricted IL-12 (trIL-12) technology that delivers potent IL-12 stimulation at the tumor site while avoiding systemic exposure. IL-12 is an immune-stimulatory cytokine that can induce potent anti-tumor activity, but systemic delivery of IL-12 has been shown to cause severe toxicity in patients.

trIL-12 was designed leveraging Outpace’s OutSmartTM technology to rapidly auto-inactivate IL-12 after inducible secretion from engineered T cells with the aim of achieving safe, local delivery of IL-12 activity. trIL-12 is being advanced under a collaboration between Lyell Immunopharma and Outpace with the goal of improving efficacy for T-cell therapies while maintaining a favorable safety profile.

"With the latest application of our OutSmartTM technology, we believe that we have successfully unlocked the therapeutic potential of IL-12, a goal that the scientific community has pursued for quite some time," remarked Dr. Scott Boyken, PhD, Chief Technology Officer. "The highly localized and conditionally controlled activity of trIL-12 is unattainable through traditional small molecule drugs or protein-based therapeutics. Our work underscores the immense therapeutic potential of cell therapies powered by protein design, and we will continue to harness our protein design expertise to address the urgent needs of patients with limited treatment options."

Poster Presentation Details

Title: Protein design and inducible expression allow context-dependent, localized IL-12 activity to enhance solid tumor T cell therapies
Session Date/Time: Friday, November 3, 2023 (12-1:30 pm, 5:10-6:40 pm)
Abstract Number: 1047 (link to full abstract)
Presenting Author: Dr. Scott Boyken, PhD, Chief Technology Officer at Outpace Bio

Consolidated Financial Results for the First Six Months of the Year Ending March 31, 2024 (Fiscal 2023)

On October 31, 2023 Daiichi Sankyo reported its Consolidated Financial Results for the First Six Months of the Year Ending March 31, 2024 (Press release, Daiichi Sankyo, OCT 31, 2023, View Source [SID1234637729]).

Trimuvira Corporate Presentation – 4th Quarter 2023

On November 7, 2023 Triumvira Immunologics presented its corporate presentation (Press release, Triumvira Immunologics, OCT 31, 2023, View Source [SID1234637165]).

Entry into a Material Definitive Agreement

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).

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.