On April 25, 2025 Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, reported preclinical data from four pipeline programs during poster sessions at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) 2025 Annual Meeting taking place in Chicago (Press release, Cogent Biosciences, APR 25, 2025, View Source [SID1234652141]).

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"We welcome the opportunity to present updated results from these programs that represent our exciting pipeline of potential best-in-class targeted therapies," said Andrew Robbins, Cogent’s President and Chief Executive Officer. "These data demonstrate Cogent’s ability to discover and advance novel therapies for rare disease populations with high unmet medical need, and we look forward to continuing to advance these candidates."

Poster Details

Title: Identification of a potent KRAS (ON) inhibitor with selectivity for mutant KRAS over HRAS and NRAS
Session Category: Chemistry
Session Title: Lead Identification and Optimization
Session Date and Time: April 30, 2025 – 9:00 AM – 12:00 PM CT (10:00 AM – 1:00 PM ET)
Location: Poster Section 25
Poster Board Number: 3
Published Abstract Number: 6974

Mutations in KRAS are among the most prevalent mutations found in cancer, occurring most often in colorectal cancer, non-small cell lung cancer and pancreatic cancer. The poster presented today describes Cogent’s internally-developed pan KRAS(ON) inhibitor program with selectivity over HRAS and NRAS and picomolar (pM) activity across KRAS mutations. In response to our 30mg/kg oral dose we observed robust PD including 90% tumor growth inhibition in a mouse TGI model. Lead optimization of this series is ongoing.

Title: Preclinical characterization of CGT6297, a novel PI3Kα H1047R mutant-selective inhibitor
Session Category: Experimental and Molecular Therapeutics
Session Title: Kinase and Phosphatase Inhibitors 2
Session Date and Time: April 28, 2025 – 2:00 PM – 5:00 PM CT (3:00 PM – 6:00 PM ET)
Location: Poster Section 20
Poster Board Number: 5
Published Abstract Number: 3004

Cogent is developing a potential best-in-class, wild-type-sparing, PI3Kα inhibitor that provides coverage for the both the H1047R mutation as well as E542K and E545K helical mutants. The phosphoinositide 3-kinase (PI3K) pathway is a key cell cycle regulating pathway that has an established role in tumor growth and development. The approved agents for these patients often lead to dose limitations, resulting from activity against wild-type PI3Kα.

In the poster being presented today, Cogent’s preclinical candidate CGT6297 demonstrates broad cellular panel profiling across multiple resistant and mutated cell lines, including, for the first time, efficacy against PI3K helical mutations. The poster also showcases the activity of CGT6297 in both ST1056 (H1047R mutant) and MCF-7 (E545K mutant) breast cancer TGI models.

Title: The Reversible and Selective FGFR2/3 inhibitor CGT4859 has superior target coverage of resistance mutations missed by leading FGFR inhibitors
Session Category: Clinical Research
Session Title: Targeted Therapies and Combinations 2
Session Date and Time: April 29, 2025 – 9:00 AM – 12:00 PM CT (10:00 AM – 1:00 PM ET)
Location: Poster Section 34
Poster Board Number: 27
Published Abstract Number: 4729

FGFR inhibitors are well-established oncogenic drivers in multiple diseases, but approved medicines fail to capture the full landscape of FGFR altered tumor types, with FGFR1-mediated hyperphosphatemia serving as the most common dose-limiting toxicity for pan-FGFR inhibitors. The poster presented today describes Cogent’s internally-developed FGFR2/3 inhibitor which maintains potency on FGFR2 mutations and is selective against the entire kinome and a broad panel of channels and receptors. Exploratory pharmacokinetics (PK) studies conducted across species showed CGT4859 to be a low-clearance compound with high oral bioavailability. Further, in an AN3 CA model, CGT4859 demonstrated dose-responsive tumor growth inhibition with complete regressions at >2.5 mg/kg QD or BID and was well-tolerated.

Cogent is currently enrolling patients in an ongoing Phase 1 trial with CGT4859 in patients with confirmed FGFR2 or FGFR3 mutations, including patients with advanced cholangiocarcinoma. The trial is designed to explore the safety, tolerability and clinical activity of escalating doses with the goal of selecting an active and well tolerated dose for further clinical investigation.

Title: Identification of CGT4255 an EGFR-sparing, pan-mutant HER2 clinical development candidate with potential best-in-class brain penetration
Session Category: Experimental and Molecular Therapeutics
Session Title: Novel Antitumor Agents 3
Session Date and Time: April 29, 2025 – 2:00 PM – 5:00 PM CT (3:00 PM – 6:00 PM ET)
Location: Poster Section 21
Poster Board Number: 1
Published Abstract Number: 5623

Cogent’s potential best-in-class EGFR-sparing, brain-penetrant ErbB2 inhibitor includes potent coverage of key mutations (YVMA, S310F, V842I, L755S) inadequately addressed by currently approved therapies. Activating mutations in the ErbB2 gene have been identified in multiple cancers and demonstrate a tumorigenic role similar to that of ErbB2 amplification. New data presented on this compound describes CGT4255’s exceptional stability in human whole blood and liver cytosol fractions and high oral bioavailability and low clearance across preclinical species. In addition, CGT4255 is expected to have equivalent brain to plasma exposure suggesting potential best-in class properties.

All posters will be available on the ‘Posters and Publications’ page of Cogent’s website.

New Leadership Appointments
Cogent also announced today that Ray Frost has joined Cogent as Senior Vice President, Market Access and Adam Boyd, Ph.D. has joined Cogent as Senior Vice President, Corporate Strategy.

Mr. Frost joins Cogent with over 20 years of industry experience. Previously he served as Vice President Market Access at Ono Pharma USA and Zealand Pharma (Zealand). While at Zealand he played an integral part in building the commercial infrastructure to support the launch of their first product. Prior to Zealand he held roles of increasing responsibility in Market Access and Health Policy at Melinta Therapeutics, The Medicines Company, Bayer Healthcare, Eisai and MGI PHARMA. Mr. Frost is a graduate of Hofstra University.

Dr. Boyd joins Cogent with nearly 25 years of industry experience building and leading global teams across Development functions including Biostatistics, Clinical Pharmacology, Clinical Operations, and Data Management. In these roles, he was instrumental in bringing several products to market, including Mektovi (binimetinib), Braftovi (encorafenib), Jakafi (ruxolitinib), and Folotyn (pralatrexate). Prior to joining Cogent, Dr. Boyd was Vice President, Biometrics at Intellia Therapeutics, and prior to that, held various roles of increasing responsibility at Pfizer, Array BioPharma, Novartis, and Allos Therapeutics. Dr. Boyd earned his Ph.D. in Biostatistics from the University of Colorado, where he is currently a member of the Colorado School of Public Health’s Dean’s Advisory Board.

Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)
Cogent also announced today that, on April 14, 2025, the Compensation Committee of Cogent’s Board of Directors, made up entirely of independent directors, approved the grants of "inducement" equity awards to five new employees, including Mr. Frost and Dr. Boyd, under the company’s 2020 Inducement Plan with a grant date of April 21, 2025. The awards were approved in accordance with Listing Rule 5635(c)(4) of the corporate governance rules of the Nasdaq Stock Market. The employees received, in the aggregate, nonqualified options to purchase 446,000 shares of Cogent common stock. Each option has a 10-year term, an exercise price equal to the closing price of Cogent’s common stock on the grant date, and a 4-year vesting schedule with 25% vesting on the 1-year anniversary of the grant date and the remainder vesting in equal monthly installments over the subsequent 36 months, provided such employee remains employed through each such vesting date.

On April 25, 2025 BillionToOne, a molecular diagnostics company with a mission to create powerful and accurate tests accessible to all, reported several abstract presentations that will be showcased at the American Association of Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting on April 25–30, 2025, in Chicago, IL (Press release, BillionToOne, APR 25, 2025, View Source [SID1234652157]).

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Each abstract highlights BillionToOne’s relentless focus in advancing the field of liquid biopsy technology:

Title: "Tumor fraction estimation and tissue copy number inference using copy number signal from a liquid biopsy assay"
Session Time: 4/29/25 at 9:00 AM – 12:00 PM
Location: Poster Section 20

Title: "Detection of a novel GNA11 processed pseudogene from cfDNA and implications for liquid biopsy"
Session Time: 4/29/25 at 2:00 – 5:00 PM
Location: Poster Section 31

Title: "Circulating cell-free methylated tumor DNA measurements correlate with plasma VAF-based tumor fraction estimates"
Session Time: 4/29/25 at 2:00 – 5:00 PM
Location: Poster Section 32

"These data presented at AACR (Free AACR Whitepaper) represent our dedication in advancing liquid biopsy testing with our proprietary single molecule precision technology and setting new standards in what can be achieved with plasma-based tests," said Dr. Gary Palmer, Chief Medical Officer, Oncology at BillionToOne. "Together, these innovations enhance the accuracy and robustness of ctDNA-based cancer profiling and monitoring, which will ultimately enable more precise treatment decisions for patients."

On April 25, 2025 TME Pharma N.V. (Euronext Growth Paris: ALTME), a clinical-stage biotechnology company focused on developing novel therapies for treatment of cancer by targeting the tumor microenvironment (TME), reported its financial results for the fiscal year ending December 31, 2024, and provides a business update (Press release, TME Pharma, APR 25, 2025, View Source [SID1234652175]).

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The Annual Report 2024, as approved by the management and supervisory boards on April 24, 2025, is available on TME Pharma’s website (www.tmepharma.com).

"TME Pharma achieved a number of significant clinical and regulatory milestones in 2024 and, as 2025 progresses, we remain committed to advancing the key initiatives that make up our strategic roadmap," said Aram Mangasarian, CEO of TME Pharma. "While strategic partnerships cannot be precisely timed, some of our discussions with potential partners and investors regarding strategic transactions for both NOX-A12 and NOX-E36 have been constructive. The regulatory validation of NOX‑A12’s Phase 2 randomized, controlled study design in glioblastoma by authorities in the US and Germany represented a key step in defining the clinical development pathway. Additionally, we have made important progress on getting NOX-E36 ready for clinical development in ophthalmic indications supported by promising preclinical data. While we pursue these clinical and strategic goals, we are also proactively preparing for contingencies to ensure operational continuity. Should strategic transactions not materialize by mid-2025, we will be ready to transition to a fully virtual and outsourced organizational structure, which would allow us to minimize costs while continuing to engage with industrial partners and investors to advance our clinical programs. By leveraging this flexible setup, we aim to preserve value for our shareholders."

Business and Clinical Highlights for 2024 and 2025 Year-to-Date

Brain Cancer (Glioblastoma) – Unprecedented Clinical Benefit

Glioblastoma is a highly aggressive and deadly form of brain cancer in which TME Pharma’s lead asset NOX-A12 has generated unprecedented clinical benefit in the GLORIA Phase 1/2 study. Newly diagnosed patients with glioblastoma tumors resistant to standard of care chemotherapy (MGMT unmethylated) and that are not amenable to complete surgical removal face a devastating prognosis of median overall survival (mOS) of approx. 10 months on standard of care. The development of effective treatments for these patients – TME Pharma’s target population in the GLORIA trial – is particularly challenging since these tumors tend to be more aggressive and less responsive to current therapies. Despite these unfavorable factors for the patients, TME Pharma’s development program of its lead asset, the CXCL12 inhibitor NOX-A12, suggests a strong signal of clinical benefit in this patient population.

In early March 2024, the Food and Drug Administration (FDA) cleared TME Pharma’s Investigational New Drug (IND) application on the basis of the protocol for its upcoming randomized Phase 2 trial in glioblastoma. Furthermore, in early April 2024, the company announced that the US FDA had granted Fast Track Designation for NOX-A12, in combination with radiotherapy and bevacizumab for newly diagnosed glioblastoma patients with chemotherapy-resistant disease and measurable tumor remaining after surgery.

Near-final efficacy data on glioblastoma patients treated with NOX-A12 combined with anti-VEGF and radiotherapy were presented by the lead investigator of the clinical trial, Dr. Frank Giordano, at a high-profile international cancer conference – the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress in September 2024 – revealing statistically significant improvement in survival for this triple combination over a standard of care reference cohort as well as NOX-A12 + radiotherapy alone (without anti-VEGF). The final median overall survival of the GLORIA 1/2 trial of the arm combining NOX-A12 with radiotherapy and bevacizumab achieved a remarkable 19.9 months. This exceeds what the company believes to be all relevant competitor studies conducted in the US or EU involving newly diagnosed, chemotherapy-resistant (MGMT unmethylated) glioblastoma patients.

Promising New Opportunities for NOX-E36 in Ophthalmology

TME Pharma’s second clinical stage asset, the CCL2 inhibitor NOX-E36, previously completed four clinical trials and has already been administered to 175 human subjects. While in an oncology setting NOX-E36 targets the tumor microenvironment by modifying the innate immune system, it has also demonstrated significant potential in addressing unmet medical need in ophthalmic diseases affected by scarring (fibrosis) and inflammation.

The anti-fibrotic mode of action of NOX-E36 has already been demonstrated in a relevant animal model, and the company believes that development in ophthalmological indications could be a promising opportunity to diversify its project portfolio. The company is pursuing resource-efficient possibilities to perform clinical studies such as investigator-initiated trials (IIT) funded and performed by research institutes, with TME Pharma supplying the drug. In parallel, TME Pharma is discussing with potential partners and venture capital firms the best way to develop NOX-E36 in the ophthalmology space with minimal or no financial contribution from TME Pharma’s shareholders.

TME Pharma has been collaborating with the Singapore Eye Research Institute (SERI) for several years and recent data from preclinical studies by SERI was selected for poster presentation at the Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting in May 2025. The preclinical data show that mNOX-E36 offers a more favorable safety profile than standard of care mitomycin C (MMC), while demonstrating comparable efficacy in reducing post-operative inflammation and scarring (fibrosis) following glaucoma filtration surgery, a common procedure to reduce intraocular pressure. Unlike MMC, mNOX-E36 does not destroy blood vessels in the conjunctiva, potentially overcoming the substantial toxicity seen with MMC, which is a key limitation of this current standard treatment. Fibrosis and inflammation are also significant causes of treatment failure in back-of-the-eye indications, such as age-related macular degeneration and proliferative diabetic retinopathy. TME Pharma believes that anti-CCL2 therapy with NOX-E36 offers a novel therapeutic approach to address these issues and potential to access larger markets.

Due to these new findings and other unpublished data, TME Pharma and SERI have filed patent applications covering use of NOX-E36 in glaucoma filtration surgery and other ophthalmic diseases to support its development through a license to an industrial partner or the creation of a new corporate entity.

Post-Period Event – AI-Driven Drug Discovery

In January 2025, TME Pharma announced a partnership with aimed analytics, a cutting-edge data analytics company, to enhance TME Pharma’s capabilities to leverage artificial intelligence (AI) in drug discovery and optimization. The goal of the collaboration is to use AI to create new and improved drug candidates with accelerated timelines and without the need for resource-intensive laboratory testing. The collaboration should also strengthen TME Pharma’s corporate profile for strategic transactions and reinforce ongoing partnering discussions.

2024 Financial Summary

TME Pharma successfully strengthened its balance sheet by raising €7.6 million (gross) in 2024. Considering cash and cash equivalents of €3.2 million as of December 31, 2024, TME Pharma has financial visibility into June 2025.

As in prior years, TME Pharma has not generated any revenues. The Group – TME Pharma N.V., TME Pharma AG and TME Pharma Inc. – does not expect to generate any revenues from any product candidates that it develops until the Group either signs a licensing agreement or obtains regulatory approval and commercializes its products or enters into collaborative agreements with third parties and relies on dilutive and non-dilutive financing until it reaches profitability.

Research and development (R&D) expenses decreased 13% from K€ 2,652 in the fiscal year (FY) 2023 to K€ 2,296 in the FY 2024. The decrease in research and development expenses in 2024 compared to 2023 is primarily due to the clinical trial of NOX-A12 in brain cancer nearing completion, which required lower costs while at the same time generating more mature data. The pancreatic cancer clinical trial phase 2 protocol which has been approved by the FDA in the US has not been initiated, thereby keeping ongoing costs related to this clinical trial minimal. As a result, TME Pharma was able to decrease drug manufacturing costs, service fees and other costs related to the clinical trials and preclinical testing, in addition to lower personnel expenses, patent costs and consulting services, partly offset by higher other research and administrative expenses.

General and administrative (G&A) expenses decreased from K€ 2,989 in the FY 2023 to K€ 2,981 in the FY 2024. The decrease in G&A expenses in 2024 compared to 2023 is mainly driven by lower personnel expenses as well as lower public and investor relations expenses and other expenses, partly offset by higher legal, consulting and audit fees in connection with the financing transactions in 2024. Other general and administrative expenses comprise mainly of depreciation of rights of use assets and equipment, supervisory board remuneration, insurance premium, and ancillary leasing costs.

The finance income in the FY 2024 and 2023 was non-cash finance income. Finance income decreased from K€ 399 in the FY 2023 to K€ 32 in the FY 2024 as a result of ending the Atlas convertible bonds financing facility with Atlas Special Opportunities LLC (ASO). Finance income in 2024 mainly resulted from fair value adjustments of detachable warrants (ABSA Warrants) issued in connection with the preferential rights issue. In 2023, finance income of K€ 237 resulted from the derecognition of conversion rights in connection with the ASO financing upon conversion and redemption of the bonds and of K€ 162 fair value adjustments of ABSA Warrants issued in connection with the preferential rights issue.

Finance cost decreased from K€ 1,518 in the FY 2023 to K€ 503 in the FY 2024 as a result of ending the Atlas convertible bonds financing facility with ASO. Finance cost in the FY 2024 and 2023 was non-cash finance cost, except for transaction costs of K€ 16 in 2024 and K€ 4 in 2023 borne by the company in conjunction with the exercise of ABSA Warrants (in 2024) and the issuance of Atlas convertible bonds (in 2023) as well as K€ 2 in 2024 and K€ 13 in 2023 relating to interest expense for lease liabilities. Finance cost in the FY 2024 of K€ 489 relate to the initial recognition of ABSA Warrants amounting to K€ 113 as well as losses of K€ 376 from exercises of such warrants. Finance cost in the FY 2023 of K€ 1,505 relate to the ASO facility (contractually entered into in 2020 and ended in 2023, except for outstanding convertible bonds that were fully redeemed in cash in the FY 2024) and comprise losses on initial recognition of convertible bonds, conversion losses, conversion right derivatives, interest in exchange for the lock-up of convertible bonds issued and outstanding as well as transaction costs.

As a result of these factors, TME Pharma N.V. reports a net loss for FY 2024 of K€ 5,722 compared to K€ 6,736 in the FY 2023, a decrease of 15%.

Outlook for 2025

TME Pharma’s strategic focus for 2025 centers on maximizing the value of its clinical-stage assets, NOX‑A12 and NOX-E36, through strategic partnerships, licensing agreements, and potential M&A. The company is pursuing these opportunities while maintaining a lean cost structure and actively preparing for a contingency plan involving a fully outsourced organizational structure, should targeted financing or strategic transactions not materialize by June 2025.

NOX-A12 in Glioblastoma

Given the unprecedented clinical data and clear regulatory pathway, TME Pharma has strategically prioritized the development of NOX-A12 in first-line, chemotherapy resistant glioblastoma since the company believes this indication offers the fastest path to regulatory approval for NOX-A12 in the solid tumor space.

The partnering package for NOX-A12 in glioblastoma is particularly attractive due to:

Significant Clinical Benefit: Statistically significant improvement in survival for NOX-A12 with radiotherapy and anti-VEGF bevacizumab compared to both the standard of care reference cohort (p=0.003) and the cohort treated with NOX-A12 and radiotherapy alone (p=0.021).
Regulatory Validation: A clear regulatory pathway with a Phase 2 design approved by the US FDA and the German BfArM and enhanced regulatory interactions with Fast-Track status granted by the FDA in the US and Orphan Drug Designations granted in the US and EU.
Commercial Protection: Commercial protection provided by the Orphan Drug Designations and potentially also by the patent application filed in 2022 covering the NOX-A12, radiotherapy and bevacizumab combination, which would provide cover into the 2040s if granted.
Non-dilutive Funding: Non-dilutive financial support of more than €7 million pledged for the approved Phase 2 trial once it is initiated, including a €2.4 million grant from the German federal government.
Trial Readiness: Clinical trial grade (GMP) NOX-A12 sufficient to rapidly initiate the approved Phase 2 trial at the six centers already open in Germany.
NOX-E36 in Ophthalmology

TME Pharma recognizing NOX-E36 potential in ophthalmology has chosen to collaborate with the Singapore Eye Research Institute (SERI) to maximize efficiency and minimize required resources for further development of the asset.

The NOX-E36 program is poised for rapid advancement into the clinic on the basis of:

Strong Scientific Rationale: Compelling preclinical proof-of-concept and clinical data supporting CCL2 as a valid target.
Funding Opportunities: Funding for Phase 1b study potentially available through grants accessible to SERI
IP Protection: Joint patent applications filed for the use of NOX-E36 in eye diseases in March 2025.
Drug Availability: GMP drug supply manufactured and ready to use pending local ocular toxicity bridging for subconjunctival administration, ensuring a smooth transition to clinic.
Established Safety Profile: Excellent systemic safety and tolerability and dose-dependent pharmacologic activity established in 175 human subjects across previous clinical trials.
As part of its most recent business planning TME Pharma is pursuing several transaction structures in parallel for its drug candidates:

Out-licensing NOX-A12: Seeking an exclusive worldwide or regional out-licensing deal for NOX-A12 program to a pharmaceutical partner. The targeted transaction structure would bring in payments upon signature and significant regulatory and commercial milestones as well as providing for royalties on sales.
Out-licensing NOX-E36: Seeking an exclusive worldwide out-licensing deal for NOX-E36 program both by TME Pharma and collaboration partner SERI to a newly formed company funded by venture capital partners.
Asset Sale: Exploring the sale of the private operational subsidiary TME Pharma AG holding assets and intellectual property to a pharmaceutical partner or investor. This would result in TME Pharma N.V. holding either cash or shares of the acquiring entity.
Virtual Setup: As a contingency plan in case none of the above can be realized by June 2025, TME Pharma is preparing to change its organizational structure to allow it to continue pursuing the goals of financing, licensing or M&A transactions focused on its clinical stage assets, NOX‑A12 and NOX-E36 while minimizing costs by outsourcing essentially all functions to maintain and advance the programs and conduct industrial partner and investor outreach.
The outsourced staffing structure will likely be the most economically efficient option to manage collaborations and develop further transactions on NOX-A12 and NOX-E36 and so TME Pharma is actively preparing to transition to a fully outsourced staffing structure at the end of June 2025.

On April 25, 2025, United Therapeutics Corporation (the "Company") entered into a Credit Agreement (the "Credit Agreement") with the lenders referred to therein and Wells Fargo Bank, National Association ("Wells Fargo"), as administrative agent and as a swingline lender (Filing, 8-K, United Therapeutics, APR 25, 2025, View Source [SID1234652250]). The Credit Agreement provides for an unsecured, revolving credit facility of up to $2.5 billion (which facility may, subject to obtaining commitments from existing or new lenders for such increase and subject to other condition, be increased by up to $750 million in the aggregate). The facility matures five years after the closing date of the Credit Agreement, subject to an ability of the lenders thereunder, or certain of the lenders thereunder, to elect to extend the maturity date of their commitments by one year following a request for such extension by the Company in accordance with the terms of the Credit Agreement, up to a maximum of two such extensions.

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As of April 25, 2025, there are no subsidiaries of the Company required to be a guarantor and guarantee the Company’s obligations under the Credit Agreement. From time to time, one or more subsidiaries of the Company may be required to guarantee the Company’s obligations under the Credit Agreement.

At the Company’s option, the loan will bear interest at either an adjusted Term SOFR rate or a fluctuating base rate, in each case, plus an applicable margin that is determined on a quarterly basis based on the Company’s consolidated total leverage ratio (as calculated in accordance with the Credit Agreement).

The proceeds of borrowings under the Credit Agreement are available to refinance certain existing indebtedness of the Company and its subsidiaries and/or for working capital and other general corporate purposes. Upon closing of the Credit Agreement on April 25, 2025, the Company borrowed $200.0 million under the Credit Agreement, and used the funds to repay outstanding indebtedness under the 2022 Credit Agreement discussed under Item 1.02 below.

The Credit Agreement also contains customary affirmative and negative covenants that, among other things, limit the ability of the Company and its subsidiaries to (a) in the case of subsidiaries that are not guarantors of the credit facility, incur indebtedness; (b) grant liens; (c) solely with respect to credit parties under the credit facility, enter into a merger, consolidation or amalgamation; (d) liquidate, wind up or dissolve; or (e) sell all or substantially all of the property, business or assets of the Company and its subsidiaries taken as a whole. In addition, as of the last day of each fiscal quarter, the Company must not permit a consolidated ratio of total indebtedness to EBITDA to be greater than 3.50 to 1.00 (which ratio may, upon consummation of (i) certain qualifying acquisitions, be increased to 4.00 to 1.00 for four fiscal quarters following such acquisition and (ii) certain qualifying inbound licensing transactions, be increased to 4.00 to 1.00 for the first two fiscal quarters following such inbound licensing transaction and 3.75 to 1.00 for the next two fiscal quarters following such inbound licensing transaction) and its consolidated interest coverage ratio to be less than 3.00 to 1.00, in each case calculated in accordance with the Credit Agreement.

The Credit Agreement contains customary events of default, including a change of control. Upon the occurrence and continuation of an event of default, all amounts due under the Credit Agreement and the other loan documents become (in the case of a bankruptcy event), or may become (in the case of all other events of default and at the option of the lenders), immediately due and payable.

The foregoing summary is qualified in its entirety by reference to the copy of the Credit Agreement attached hereto as Exhibit 10.1.

On April 25, 2025 Daiichi Sankyo reported Consolidated Financial Results for Year Ended March 31, 2025 (Fiscal 2024) (Filing, 3 mnth, MAR 31, Daiichi Sankyo, 2025, APR 25, 2025, View Source [SID1234654298]).

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