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[DEFINITIONS](index=2&type=section&id=ARTICLE%201) This section defines capitalized terms used throughout the Loan and Security Agreement for consistent interpretation of financial, legal, and operational aspects [Defined Terms](index=2&type=section&id=1.1%20Defined%20Terms) This section defines capitalized terms used throughout the Loan and Security Agreement, ensuring consistent interpretation of financial, legal, and operational aspects - The 'Applicable Rate' for interest is a variable annual rate, defined as the greater of (i) the Prime Rate plus **3.00%** and (ii) **9.75%**[16](index=16&type=chunk) - A 'Change of Control' occurs if Borrower merges, consolidates, sells substantially all assets, or if any person acquires **35%** or more of Borrower's outstanding capital stock[20](index=20&type=chunk) - An 'Event of Default' includes failure to pay principal or interest when due, material breach of covenants, incorrect representations, bankruptcy filings, or a Material Adverse Change[32](index=32&type=chunk)[33](index=33&type=chunk)[34](index=34&type=chunk)[35](index=35&type=chunk)[36](index=36&type=chunk) - The 'Interest Only Period' extends from the Closing Date to November 1, 2028, but can be extended to November 1, 2029, if the Borrower achieves the Product Revenue Milestone by June 30, 2028[53](index=53&type=chunk) - The 'Product Revenue Milestone' requires Borrower to generate at least **$50,000,000** in Product Revenue on a trailing six-month basis by June 30, 2028[92](index=92&type=chunk) Term | Definition Summary | Term | Definition Summary | | :--- | :--- | | **Applicable Rate** | Greater of Prime Rate + 3.00% or 9.75% annually | | **Change of Control** | Merger, consolidation, substantial asset sale, or 35%+ capital stock acquisition | | **Closing Date** | October 14, 2025 | | **Commitment Fee** | 1.0% of each Advance, non-refundable | | **Default Rate** | Applicable Rate + 400 basis points during an Event of Default | | **End of Term Payment** | 4.25% of original principal amount of funded Loans, due at maturity or prepayment | | **Maturity Date** | October 1, 2030 | | **Product Revenue Milestone** | $50,000,000 Product Revenue on a trailing 6-month basis by June 30, 2028 | [THE LOANS](index=19&type=section&id=ARTICLE%202) This article details the terms and conditions governing the term loans, including commitment, payment schedules, and specific tranches [The Loans](index=19&type=section&id=2.1%20The%20Loans) This section outlines the terms for term loans, including lender commitments, payment schedules, and available tranches for the Borrower - Lenders agree to make loans up to their respective Commitments, with an immediate repayment required if outstanding principal exceeds Total Commitments[112](index=112&type=chunk) - Borrower will make monthly interest-only payments during the Interest Only Period, followed by equal monthly amortizing payments until the Maturity Date[112](index=112&type=chunk) Loan Tranches and Amounts | Tranche | Amount | | :--- | :--- | | Tranche A Loan | $50,000,000 | | Tranche B Loan | $20,000,000 | | Tranche C Loan | $30,000,000 | | Tranche D Loan | $30,000,000 | | **Total Commitments** | **$130,000,000** | - A non-refundable Commitment Fee of **1.0%** of each Advance and Documentation and Funding Fees are payable at the time of each Advance[23](index=23&type=chunk)[114](index=114&type=chunk)[116](index=116&type=chunk) [Advances and Interest](index=20&type=section&id=2.2%20Advances%20and%20Interest) This section details procedures for requesting loan advances, applied deductions, and the calculation and payment of interest, including late charges and default rates - Loan requests must be submitted by 2:00 P.M. New York time, five Business Days prior to the requested loan date (except for Tranche A on Closing Date), and Borrower may not request more than one loan per calendar month[115](index=115&type=chunk) - The unpaid principal balance of all advanced Loans bears interest at the Applicable Rate, payable in arrears on the first day of each month[117](index=117&type=chunk) - A late charge of **5%** of the past due payment is imposed if a monthly payment is not made within five Business Days of its due date[117](index=117&type=chunk) - During an Event of Default, the interest rate on outstanding Loans increases to the Default Rate, which is **400 basis points** above the Applicable Rate[117](index=117&type=chunk) [Administrative Agent Accounts](index=21&type=section&id=2.3%20Administrative%20Agent%20Accounts) This section specifies the Administrative Agent's responsibility for maintaining detailed accounts of all loans, principal, interest, and sums received for Lenders - Administrative Agent shall maintain accounts to record the amount of each Loan, principal and interest due, and sums received for Lenders[121](index=121&type=chunk) [Conditions Precedent to Each Advance](index=21&type=section&id=2.4%20Conditions%20Precedent%20to%20Each%20Advance) This section outlines general conditions for any loan advance, ensuring Borrower compliance and Agent satisfaction with due diligence - All representations and warranties must be true and correct in all material respects, and no Event of Default or Potential Event of Default can be continuing[122](index=122&type=chunk) - The Borrower must deliver an executed Loan Advance Request Form, and all governmental and third-party approvals must be in full force and effect[122](index=122&type=chunk) - The Documentation and Funding Fee and applicable Commitment Fee must be paid, and the Administrative Agent must be satisfied with its due diligence investigation[122](index=122&type=chunk) [Conditions Precedent to the Tranche A Loan](index=22&type=section&id=2.5%20Conditions%20Precedent%20to%20the%20Tranche%20A%20Loan) This section details specific conditions for the initial Tranche A Loan, focusing on security perfection and existing debt refinancing - Borrower must provide UCC-1 financing statements, a certificate of authorizing resolutions, Operating Documents, and good standing certificates[123](index=123&type=chunk) - Insurance certificates, a recent Lien search (showing only Permitted Liens), and fully executed Account Control Agreements for Deposit and Securities Accounts are required[123](index=123&type=chunk) - A payoff letter and release of Liens for the Existing SVB Facility must be provided, along with a legal opinion of counsel to Borrower[123](index=123&type=chunk) [Conditions Precedent to Subsequent Tranches](index=23&type=section&id=2.6%20Conditions%20Precedent%20to%20Subsequent%20Tranches) This section outlines specific conditions for advancing subsequent loan tranches, including achieving milestones and obtaining investment committee approval - Advance of Tranche B Loan requires evidence satisfactory to the Administrative Agent that Borrower has achieved certain undisclosed milestones[124](index=124&type=chunk) - Advance of Tranche C Loan requires the Tranche B Loan to have occurred and evidence that Borrower has received certain undisclosed funds[124](index=124&type=chunk) - Advance of Tranche D Loan requires the Tranche C Loan to have occurred and approval by the Lenders' investment committee in its sole discretion[124](index=124&type=chunk) [Voluntary Prepayment](index=23&type=section&id=2.7%20Voluntary%20Prepayment) This section details terms for voluntary prepayment of Loans, including calculation of a Prepayment Premium based on timing - Borrower may prepay Loans in whole or in part at any time, subject to a Prepayment Premium and the End of Term Payment[125](index=125&type=chunk) Prepayment Premium Schedule | Prepayment Timing | Premium Rate (of principal repaid) | | :--- | :--- | | On or before 1st anniversary of Closing Date | 3.0% | | After 1st and on or before 2nd anniversary of Closing Date | 2.0% | | After 2nd anniversary of Closing Date and before Maturity Date | 1.0% | [Mandatory Prepayment](index=23&type=section&id=2.8%20Mandatory%20Prepayment) This section specifies events triggering mandatory prepayment of Loans, such as a Change of Control or acceleration due to an Event of Default - A mandatory prepayment is triggered by a Change of Control or acceleration following an Event of Default[127](index=127&type=chunk) - The prepayment amount includes all outstanding principal, accrued and unpaid interest, the Prepayment Premium, and all other due and payable Obligations[127](index=127&type=chunk) [End of Term Payment](index=23&type=section&id=2.9%20End%20of%20Term%20Payment) This section defines the 'End of Term Payment' due on the Maturity Date or upon earlier prepayment or acceleration of the Loans - An 'End of Term Payment' equal to **4.25%** of the original principal amount of the funded Loans is due on the Maturity Date or upon earlier prepayment/acceleration[128](index=128&type=chunk) [Proceeds of Collateral](index=23&type=section&id=2.10%20Proceeds%20of%20Collateral) This section outlines how proceeds from Collateral will be handled and applied by the Administrative Agent following an Event of Default - Upon an Event of Default, all proceeds from the Collateral must be delivered to the Administrative Agent and applied to the Obligations at the Agent's sole discretion[129](index=129&type=chunk) [Tax Matters](index=23&type=section&id=2.11%20Tax%20Matters) This section details tax obligations and responsibilities of the Borrower, Lenders, and Administrative Agent, including withholding taxes and FATCA compliance - Borrower must make payments without deduction for Taxes, unless required by law, and will increase the sum payable for Indemnified Taxes[131](index=131&type=chunk) - Borrower indemnifies Lenders and Administrative Agent for Indemnified Taxes, and Lenders severally indemnify the Administrative Agent for certain Taxes[133](index=133&type=chunk)[134](index=134&type=chunk) - Lenders must deliver documentation (e.g., IRS Form W-9, W-8BEN) to claim exemption or reduction from withholding tax, and FATCA is included in 'applicable law'[138](index=138&type=chunk)[139](index=139&type=chunk)[141](index=141&type=chunk) - For U.S. federal income tax purposes, the Warrant issued to each Lender is part of an investment unit with the Tranche A Loan, and a portion of the issue price will be allocated to the Warrant based on its fair market value[143](index=143&type=chunk) [Apportionment of Payments](index=27&type=section&id=2.12%20Apportionment%20of%20Payments) This section specifies that all payments of principal, interest, fees, and other obligations will be allocated among Lenders in proportion to their Pro Rata Shares - All payments are allocated by the Administrative Agent among entitled Lenders in proportion to their respective Pro Rata Shares[144](index=144&type=chunk) [Defaulting Lenders](index=27&type=section&id=2.13%20Defaulting%20Lenders) This section outlines consequences for 'Defaulting Lenders,' including restrictions on approval rights and redirection of payments - A Defaulting Lender's right to approve amendments, waivers, or consents is restricted as per the 'Required Lenders' definition[145](index=145&type=chunk) - Administrative Agent is not obligated to transfer payments to a Defaulting Lender; such payments may be transferred to non-Defaulting Lenders ratably[146](index=146&type=chunk) [CREATION OF SECURITY INTEREST; COLLATERAL](index=28&type=section&id=ARTICLE%203) This article details the grant of security interests by the Borrower to the Administrative Agent, covering a broad range of assets as Collateral [Grant of Security Interests](index=28&type=section&id=3.1%20Grant%20of%20Security%20Interests) This section details the Borrower's grant of a valid, continuing security interest in all present and future assets to the Administrative Agent for Lenders' benefit - Borrower grants a valid, continuing security interest in all presently existing and hereafter acquired or arising Collateral to Administrative Agent for the benefit of Lenders[150](index=150&type=chunk) - Collateral includes goods, equipment, inventory, contract rights, general intangibles (including Intellectual Property), accounts, cash, Deposit Accounts, and other personal property, but excludes 'Excluded Property'[150](index=150&type=chunk)[151](index=151&type=chunk) [After-Acquired Property](index=29&type=section&id=3.2%20After-Acquired%20Property) This section requires the Borrower to notify the Administrative Agent and grant a security interest in any significant commercial tort claims acquired - Borrower must notify Administrative Agent and grant a security interest in any commercial tort claim exceeding **$200,000**[152](index=152&type=chunk) [Location and Possession of Collateral](index=29&type=section&id=3.3%20Location%20and%20Possession%20of%20Collateral) This section specifies permitted locations for Collateral and Borrower's responsibilities regarding notification and waivers for new or third-party storage - Collateral must remain at Permitted Locations or other locations with written notice to Administrative Agent within **20 Business Days** of relocation[153](index=153&type=chunk) - For new locations with collateral valued over **$500,000**, Borrower must obtain bailee or landlord waivers within **30 days**[153](index=153&type=chunk) [Delivery of Additional Documentation Required](index=29&type=section&id=3.4%20Delivery%20of%20Additional%20Documentation%20Required) This section obligates the Borrower to execute and deliver additional documents as requested by the Administrative Agent to perfect and maintain security interests - Borrower must execute and deliver financing statements and other documents to perfect and continue Administrative Agent's security interests in the Collateral[154](index=154&type=chunk) [Right to Inspect](index=29&type=section&id=3.5%20Right%20to%20Inspect) This section grants the Administrative Agent the right to inspect Borrower's books, records, and Collateral to verify financial condition and status - Administrative Agent has the right to inspect Borrower's books, records, and Collateral at any time during an Event of Default, or once per year with prior notice when no default is continuing[155](index=155&type=chunk) - Borrower may exclude attorney-client privileged information or information creating a conflict of interest[155](index=155&type=chunk) [Intellectual Property](index=29&type=section&id=3.6%20Intellectual%20Property) This section outlines Borrower's obligations to notify the Administrative Agent of federal IP registrations, provide quarterly reports, and execute security interest grants - Borrower must notify Administrative Agent before federal registration of any copyright or copyright application and execute security interest grants[156](index=156&type=chunk) - Borrower must deliver quarterly Patent and Trademark Reports and execute security interest grants for newly registered or filed patents and trademarks[156](index=156&type=chunk) [Protection of Intellectual Property](index=30&type=section&id=3.7%20Protection%20of%20Intellectual%20Property) This section details Borrower's affirmative covenants regarding the protection, defense, and maintenance of its material Intellectual Property - Borrower must protect, defend, and maintain the validity and enforceability of its material Intellectual Property and promptly advise Administrative Agent of material infringements[157](index=157&type=chunk) - Borrower must provide written notice within **15 Business Days** of entering any Restricted License (excluding over-the-counter software)[157](index=157&type=chunk) - Borrower must take commercially reasonable steps to obtain consent or waiver for Restricted Licenses to be deemed Collateral and for Agent to have a security interest[157](index=157&type=chunk) [REPRESENTATIONS, WARRANTIES AND COVENANTS](index=30&type=section&id=ARTICLE%204) This article contains Borrower's factual statements and assurances regarding its legal status, financial condition, assets, and compliance with loan terms [Representations and Warranties](index=30&type=section&id=4.1%20Representations%20and%20Warranties) This section contains Borrower's factual statements and assurances regarding its legal status, financial condition, assets, compliance, and validity of Loan Documents - Borrower and its Subsidiaries are duly organized, validly existing, and in good standing, with full power and authority to execute and perform Loan Documents[159](index=159&type=chunk)[160](index=160&type=chunk) - Borrower has good and marketable title to the Collateral, free and clear of Liens other than Permitted Liens, and the security interest granted to Administrative Agent is perfected and first priority[161](index=161&type=chunk)[162](index=162&type=chunk) - Financial Statements are true and correct in all material respects and fairly present the consolidated financial condition in conformity with GAAP[160](index=160&type=chunk) - Borrower and its Subsidiaries are in material compliance with all applicable Healthcare Laws and have obtained all necessary Healthcare Permits[163](index=163&type=chunk)[164](index=164&type=chunk)[165](index=165&type=chunk)[166](index=166&type=chunk)[167](index=167&type=chunk)[168](index=168&type=chunk) [Affirmative Covenants of Borrower](index=35&type=section&id=4.2%20Affirmative%20Covenants%20of%20Borrower) This section outlines actions Borrower and its Subsidiaries must take to maintain legal and financial standing, comply with loan terms, and provide ongoing information - Borrower must maintain corporate existence, good standing, all necessary licenses and approvals, and comply with all applicable laws, including Healthcare Laws and HIPAA[169](index=169&type=chunk) - Borrower must deliver monthly unaudited financial statements, an updated Perfection Certificate, bank statements, and a Compliance Certificate within **30 days** after month-end[170](index=170&type=chunk) - Annual audited financial statements must be delivered within **180 days** after fiscal year-end, along with annual operating budgets and financial projections[171](index=171&type=chunk)[174](index=174&type=chunk) - Borrower must use loan proceeds for specific purposes: Tranche A for refinancing the Existing SVB Facility and working capital, subsequent tranches solely for working capital and general corporate purposes[177](index=177&type=chunk) - Borrower must maintain minimum Liquidity based on Market Capitalization, specifically **67.5%** of outstanding Obligations from July 1, 2026, and **75%** from October 1, 2027 (or earlier upon certain events)[177](index=177&type=chunk) - Borrower must deliver landlord/bailee waivers, insurance endorsements, a subordination agreement for Diamyd Debt, and the original stock certificate for MSC Subsidiary within specified post-closing periods[178](index=178&type=chunk) [Negative Covenants of Borrower](index=41&type=section&id=4.3%20Negative%20Covenants%20of%20Borrower) This section prohibits Borrower and its Subsidiaries from certain actions without Administrative Agent's consent, restricting activities that could adversely affect security or financial health - Borrower cannot change its legal name or jurisdiction without prior written notice, or its chief executive office without prompt written notice[179](index=179&type=chunk) - Borrower is prohibited from creating any Liens on Property or Collateral, except for Permitted Liens[179](index=179&type=chunk) - Restrictions apply to mergers, consolidations, liquidations, acquisitions of other entities, and engaging in business outside its current scope or reasonably related activities[179](index=179&type=chunk) - Borrower cannot pay dividends, make distributions on Equity Securities, or repurchase its own Equity Securities (with limited exceptions for employee plans and stock conversions)[180](index=180&type=chunk) - Borrower cannot incur any Debt except Permitted Debt, and specifically cannot incur Debt involving the sale or financing of accounts receivables without prior written consent[181](index=181&type=chunk) - Borrower must not engage in transactions with Blocked Persons or fail to maintain Deposit Accounts or Securities Accounts subject to Administrative Agent's control (other than Excluded Accounts)[181](index=181&type=chunk) [AGENT](index=43&type=section&id=ARTICLE%205) This article defines the role, authority, and responsibilities of the Administrative Agent and Collateral Agent acting on behalf of the Lenders [Appointment](index=43&type=section&id=5.1%20Appointment) This section formally appoints Trinity Capital Inc. as Administrative Agent and Collateral Agent, outlining its authority to act on behalf of Lenders - Trinity Capital Inc. is irrevocably appointed as Administrative Agent and Collateral Agent, authorized to take actions and exercise rights on behalf of Lenders[183](index=183&type=chunk)[185](index=185&type=chunk) - The Administrative Agent has no fiduciary relationship with any Lender and only duties expressly set forth in the Loan Documents[183](index=183&type=chunk) [Delegation of Duties](index=44&type=section&id=5.2%20Delegation%20of%20Duties) This section permits the Administrative Agent to delegate duties through agents or attorneys-in-fact, with exculpatory and indemnification provisions applying to delegates - Administrative Agent may execute duties through agents or attorneys-in-fact and is entitled to legal counsel advice[186](index=186&type=chunk) [Exculpatory Provisions](index=44&type=section&id=5.3%20Exculpatory%20Provisions) This section limits the liability of the Administrative Agent and its affiliates, officers, and directors, unless due to gross negligence or willful misconduct - Administrative Agent is not liable to Lenders for actions or omissions unless resulting from its gross negligence or willful misconduct, as determined by a final, nonappealable judgment[187](index=187&type=chunk) - Administrative Agent is not responsible for Borrower's representations, the validity of Loan Documents, Borrower's financial condition, or the perfection of Liens (unless expressly directed by Required Lenders)[187](index=187&type=chunk) [Reliance by the Administrative Agent](index=45&type=section&id=5.4%20Reliance%20by%20the%20Administrative%20Agent) This section grants the Administrative Agent the right to rely on communications, documents, and advice, and to act based on instructions from Required Lenders - Administrative Agent may rely on communications, documents, and advice from legal counsel, accountants, and experts[189](index=189&type=chunk) - Agent may request and rely on instructions from Required Lenders before taking action and is fully protected when acting in accordance with such requests[189](index=189&type=chunk) [Notice of Default](index=46&type=section&id=5.5%20Notice%20of%20Default) This section defines how the Administrative Agent receives and acts upon notices of Potential Event of Default or Event of Default, requiring written notification - Administrative Agent is deemed to have knowledge of default only upon receiving written 'notice of default' from a Lender or Borrower[191](index=191&type=chunk) - Upon receiving such notice, Agent will notify Lenders and take action as reasonably directed by the Required Lenders[191](index=191&type=chunk) [Non-Reliance on Administrative Agent and Other Lenders](index=46&type=section&id=5.6%20Non-Reliance%20on%20Administrative%20Agent%20and%20Other%20Lenders) This section clarifies that each Lender is responsible for its own independent appraisal of Borrower's creditworthiness and does not rely on the Administrative Agent - Each Lender acknowledges making its own independent appraisal and investigation of Borrower's condition and creditworthiness[192](index=192&type=chunk) - Administrative Agent has no duty to provide Lenders with credit or other information concerning Borrower, except as expressly required[192](index=192&type=chunk) [Indemnification](index=46&type=section&id=5.7%20Indemnification) This section stipulates that Lenders agree to indemnify the Administrative Agent and its related parties for liabilities arising from Loan Documents, ratably by Pro Rata Shares - Lenders agree to indemnify Agent Indemnitees ratably for liabilities arising from Loan Documents, to the extent not reimbursed by Borrower[193](index=193&type=chunk) - No Lender is liable for liabilities resulting from an Agent Indemnitee's bad faith, gross negligence, or willful misconduct[194](index=194&type=chunk) [Administrative Agent in Its Individual Capacity](index=47&type=section&id=5.8%20Administrative%20Agent%20in%20Its%20Individual%20Capacity) This section clarifies that the Administrative Agent, in its individual capacity, retains the same rights and powers as any other Lender and can engage in business with Borrower - Administrative Agent and its affiliates may engage in business with Borrower and have the same rights as any Lender with respect to its own Loans[195](index=195&type=chunk) [Successor Administrative Agent](index=47&type=section&id=5.9%20Successor%20Administrative%20Agent) This section outlines the process for the Administrative Agent's resignation and the appointment of a successor, including notice periods and approval requirements - Administrative Agent may resign with **30 days' notice** to Lenders and Borrower[196](index=196&type=chunk) - Required Lenders appoint a successor agent, subject to Borrower's written approval (unless an Event of Default is continuing)[196](index=196&type=chunk) [Authorization for Intercreditor Agreement and Subordination Agreement](index=48&type=section&id=5.10%20Authorization%20for%20Intercreditor%20Agreement%20and%20Subordination%20Agreement) This section irrevocably authorizes the Administrative Agent to enter into and perform obligations under intercreditor and subordination agreements permitted by the Loan Agreement - Lenders irrevocably authorize Administrative Agent to enter into and perform obligations under permitted subordination and intercreditor agreements[197](index=197&type=chunk) [Administrative Agent May File Proofs of Claim](index=48&type=section&id=5.11%20Administrative%20Agent%20May%20File%20Proofs%20of%20Claim) This section grants the Administrative Agent authority to file proofs of claim and take other actions in judicial proceedings (e.g., bankruptcy) on behalf of Lenders - Administrative Agent is empowered to file and prove claims for all Obligations in judicial proceedings (e.g., bankruptcy) on behalf of Lenders[198](index=198&type=chunk) - Lenders agree not to support any reorganization plan contravening or not supported by the Administrative Agent[199](index=199&type=chunk) [Collateral Matters](index=48&type=section&id=5.12%20Collateral%20Matters) This section outlines the Administrative Agent's authority regarding Collateral, including perfecting Liens, releasing Collateral, and entering subordination agreements - Administrative Agent is authorized to take actions to perfect and maintain Liens on Collateral and to release Liens under specified conditions (e.g., full repayment, permitted dispositions)[200](index=200&type=chunk)[201](index=201&type=chunk) - Lenders irrevocably authorize Agent to enter into subordination and intercreditor agreements[202](index=202&type=chunk) - No Lender (other than the Administrative Agent) has individual rights to realize upon Collateral or enforce Obligations; these rights are exercised solely by the Administrative Agent[203](index=203&type=chunk) [BORROWER'S INDEMNITY](index=50&type=section&id=ARTICLE%206) This article obligates the Borrower to indemnify the Administrative Agent, Lenders, and their affiliates against claims and expenses arising from loan transactions [Indemnity By Borrower](index=50&type=section&id=6.1%20Indemnity%20By%20Borrower) This section obligates Borrower to indemnify Indemnified Persons against claims, damages, and expenses arising from loan transactions, breaches, or violations - Borrower indemnifies Indemnified Persons against claims, damages, losses, and expenses arising from loan transactions, Borrower's breaches, violations of law, or material misrepresentations[207](index=207&type=chunk)[209](index=209&type=chunk) - Indemnification excludes claims based on the gross negligence or willful misconduct of the Administrative Agent or a Lender[207](index=207&type=chunk) [Defense of Claims](index=50&type=section&id=6.2%20Defense%20of%20Claims) This section outlines Borrower's responsibility for paying indemnity amounts and its right to defend claims, subject to Administrative Agent's approval of counsel - Borrower agrees to pay all indemnity amounts promptly upon notice[208](index=208&type=chunk) - Borrower may defend claims with counsel acceptable to Administrative Agent, but Agent selects counsel if the claim poses significant exposure or establishes adverse legal principles[208](index=208&type=chunk) [Survival](index=51&type=section&id=6.3%20Survival) This section states that all indemnities and agreements within Article 6 will remain in full force and effect even after Agreement termination and full payment - All indemnities and agreements in Article 6 survive the termination of the Agreement and full payment of Loans and Obligations[211](index=211&type=chunk) [DEFAULT](index=51&type=section&id=ARTICLE%207) This article outlines the rights and remedies available to the Administrative Agent and Lenders upon the occurrence of an Event of Default [Rights on Default](index=51&type=section&id=7.1%20Rights%20on%20Default) This section enumerates rights and remedies available to the Administrative Agent upon an Event of Default, including acceleration, collateral disposition, and use of Intellectual Property - Upon an Event of Default, Administrative Agent may declare loans immediately due, terminate further loan obligations, and require Borrower to assemble Collateral[213](index=213&type=chunk) - Administrative Agent is granted a non-exclusive, irrevocable, perpetual, fully paid, royalty-free license to use Borrower's Intellectual Property solely for collateral disposition[213](index=213&type=chunk) - Administrative Agent may sell or dispose of Collateral, occupy Borrower's premises, commence bankruptcy proceedings, and exercise set-off rights[213](index=213&type=chunk) - Borrower waives claims against Administrative Agent and Lenders arising from the exercise of rights, except for gross negligence or willful misconduct[215](index=215&type=chunk) [Automatic Acceleration](index=53&type=section&id=7.2%20Automatic%20Acceleration) This section specifies that all Obligations become immediately due and payable automatically upon certain bankruptcy-related Events of Default without Agent action - All Obligations become immediately due and payable automatically upon bankruptcy-related Events of Default (clauses (f) or (g) of the definition of Event of Default)[218](index=218&type=chunk) [Rights Cumulative; Waivers](index=53&type=section&id=7.3%20Rights%20Cumulative%3B%20Waivers) This section clarifies that Administrative Agent and Lenders' rights and remedies are cumulative, and no delay or waiver of default constitutes a continuing waiver - All rights, remedies, and powers of Administrative Agent and Lenders are irrevocable and cumulative, not alternative or exclusive[219](index=219&type=chunk) - No delay or waiver of any default by Administrative Agent or any Lender constitutes a continuing waiver[220](index=220&type=chunk) - Borrower remains liable for any deficiency after foreclosure or sale of Collateral[220](index=220&type=chunk) [MISCELLANEOUS](index=54&type=section&id=ARTICLE%208) This article covers various general provisions including costs, power of attorney, assignments, notices, governing law, and confidentiality [Costs and Expenses](index=54&type=section&id=8.1%20Costs%20and%20Expenses) This section states that the Borrower is responsible for paying all Administrative Agent's Expenses and Lender's Expenses upon demand - Borrower will pay all Administrative Agent's Expenses and Lender's Expenses within **ten Business Days** of demand[222](index=222&type=chunk) [Power of Attorney](index=54&type=section&id=8.2%20Power%20of%20Attorney) This section grants an irrevocable power of attorney to the Administrative Agent to act on behalf of the Borrower, particularly upon an Event of Default - Borrower irrevocably appoints Administrative Agent as its attorney-in-fact to collect payments, sign documents, settle disputes, and perfect security interests[223](index=223&type=chunk) - This power of attorney is coupled with an interest and is irrevocable until all Obligations are fully repaid and Lenders' obligations terminate[223](index=223&type=chunk) [Survival](index=54&type=section&id=8.3%20Survival) This section confirms that all representations, warranties, and indemnities in the Agreement survive its execution, consummation, payment, and termination - All representations, warranties, and indemnities survive the execution, consummation, payment, performance, and termination of the Agreement[224](index=224&type=chunk) [Assignments](index=54&type=section&id=8.4%20Assignments) This section specifies that Lenders may assign the Agreement or sell participations without Borrower's consent, while Borrower is prohibited from assigning - Any Lender may assign this Agreement or sell participations without notice to Borrower or Borrower's consent[225](index=225&type=chunk) - Borrower may not assign, transfer, or convey this Agreement without Administrative Agent's and each Lender's prior written consent[225](index=225&type=chunk) [No Brokers](index=54&type=section&id=8.5%20No%20Brokers) This section includes a representation by the Borrower that no brokers or advisors have been retained for the transactions contemplated by the Agreement - Borrower represents that no brokers or advisors have been or will be retained for the transactions contemplated herein[226](index=226&type=chunk) [Notice](index=55&type=section&id=8.6%20Notice) This section sets forth requirements for validly giving notices, consents, requests, and other communications under the Agreement, including delivery methods - All notices must be in writing and sent by overnight courier, certified U.S. mail, or electronic mail[227](index=227&type=chunk) - Notices are deemed received within **five Business Days** if mailed, **one Business Day** if sent by overnight courier, or on the day of transmission if by electronic mail with confirmation[227](index=227&type=chunk) [Governing Law; Consent to Jurisdiction and Service of Process](index=55&type=section&id=8.7%20Governing%20Law%3B%20Consent%20to%20Jurisdiction%20and%20Service%20of%20Process) This section establishes New York law as governing, with parties irrevocably submitting to New York courts' jurisdiction and venue, waiving personal service - The Agreement is governed by the laws of the State of New York[228](index=228&type=chunk) - All parties irrevocably submit to the jurisdiction and venue of federal, state, or local courts in New York for disputes[228](index=228&type=chunk) - Parties waive personal service of process, consenting to service by certified mail, and waive claims of inconvenient forum[228](index=228&type=chunk) [Other Documents](index=55&type=section&id=8.8%20Other%20Documents) This section requires Borrower to execute other documents and cooperate with Administrative Agent as reasonably necessary to effectuate transactions - Borrower shall execute other documents and cooperate with Administrative Agent as reasonably required to effectuate transactions[229](index=229&type=chunk) [Severability](index=55&type=section&id=8.9%20Severability) This section states that if any part of the Agreement is found contrary to law or defective, the remaining provisions will remain in full force and effect - If any part of the Agreement is contrary to law or defective, other provisions remain in full force and effect[230](index=230&type=chunk) [Entirety; Amendments](index=55&type=section&id=8.10%20Entirety%3B%20Amendments) This section declares the Agreement and Exhibits constitute the entire agreement, superseding prior understandings, with modifications effective only if in writing - This Agreement and Exhibits constitute the entire agreement, superseding all prior agreements[231](index=231&type=chunk) - No other agreements will modify or terminate this Agreement unless in writing and duly executed by the charged party[231](index=231&type=chunk) [Waiver of Jury Trial](index=56&type=section&id=8.11%20Waiver%20of%20Jury%20Trial) This section includes an unconditional and irrevocable waiver by each party of their right to a jury trial for any claim arising from the Agreement - Each party unconditionally and irrevocably waives its right to a jury trial for any claim or cause of action arising from this Agreement or related documents[232](index=232&type=chunk) - This waiver is intended to be all-encompassing and applies to any subsequent amendments, renewals, supplements, and modifications[232](index=232&type=chunk) [Publicity](index=56&type=section&id=8.12%20Publicity) This section grants Lenders the right to make public announcements and include transaction information in marketing materials and SEC reports - Each Lender has the right to make public announcements and include transaction information on its website and marketing materials, subject to mutual agreement with Borrower on content and timing[233](index=233&type=chunk) - Lenders may include transaction information in their periodic SEC reports as required[233](index=233&type=chunk) [Demand Waiver](index=56&type=section&id=8.13%20Demand%20Waiver) This section states that the Borrower waives, to the fullest extent permitted by law, various demands and notices related to default, payment, and nonpayment - Borrower waives demand, notice of default or dishonor, notice of payment and nonpayment, and notice of any default[234](index=234&type=chunk) [Counterparts](index=56&type=section&id=8.14%20Counterparts) This section allows the Agreement to be executed in multiple counterparts, each considered an original, and confirms effectiveness of electronic transmission - The Agreement may be executed in any number of counterparts, each constituting an original[235](index=235&type=chunk) - Delivery of executed signature pages by facsimile, PDF, or other electronic transmission is as effective as manual execution[235](index=235&type=chunk) [Electronic Execution of Certain Other Documents](index=56&type=section&id=8.15%20Electronic%20Execution%20of%20Certain%20Other%20Documents) This section confirms that electronic signatures and records have the same legal effect, validity, and enforceability as manually executed signatures or paper records - Electronic signatures and records for documents related to this Agreement are deemed to have the same legal effect as manually executed signatures or paper records[236](index=236&type=chunk) [Correction of Loan Documents](index=56&type=section&id=8.16%20Correction%20of%20Loan%20Documents) This section permits the Administrative Agent to correct patent errors and fill blanks in Loan Documents, with Borrower's prior written consent - Administrative Agent may correct patent errors and fill blanks in Loan Documents, with Borrower's prior written consent (deemed given if no response within **10 Business Days**)[237](index=237&type=chunk) [Right of Set Off](index=56&type=section&id=8.17%20Right%20of%20Set%20Off) This section grants the Administrative Agent a Lien, security interest, and right of set-off against all Borrower's deposits, credits, and property held by Agent - Borrower grants Administrative Agent a Lien, security interest, and right of set-off against all Borrower's deposits, credits, and property held by Agent or its affiliates[238](index=238&type=chunk) - Upon an Event of Default, Agent may set off and apply funds to any liability or obligation of Borrower, even if unmatured, without demand or notice[238](index=238&type=chunk) [Registers](index=57&type=section&id=8.18%20Registers) This section mandates the Administrative Agent to maintain a 'Register' for Lenders and each Lender to maintain a 'Participant Register' for participants - Administrative Agent maintains a 'Register' for Lenders, recording names, addresses, Commitments, and principal amounts of Loans[240](index=240&type=chunk) - Each Lender selling a participation must maintain a 'Participant Register' for participants' names, addresses, and principal amounts of interests[241](index=241&type=chunk) [Confidentiality](index=57&type=section&id=8.19%20Confidentiality) This section outlines confidentiality obligations of the Administrative Agent and Lenders regarding Borrower's confidential information, specifying permitted disclosures - Administrative Agent and Lenders must exercise the same degree of care for Borrower's confidential information as for their own proprietary information[242](index=242&type=chunk) - Permitted disclosures include to affiliates, prospective transferees (with confidentiality agreement), as required by law/regulation, to regulators, for exercising remedies, and to third-party advisors[242](index=242&type=chunk) - Confidential information excludes public domain information or information disclosed by a third party without knowledge of a prohibition[243](index=243&type=chunk) [Managerial Assistance](index=58&type=section&id=8.20%20Managerial%20Assistance) This section acknowledges that Trinity Capital Inc. and Eagle Point Trinity Senior Secured Lending Company, as BDCs, must offer managerial assistance to portfolio companies - Trinity Capital Inc. and Eagle Point Trinity Senior Secured Lending Company, as BDCs, are required to make significant managerial assistance available to portfolio companies[244](index=244&type=chunk) - Borrower acknowledges and agrees it may request such assistance at any time[244](index=244&type=chunk) [Termination](index=58&type=section&id=8.21%20Termination) This section specifies that the Agreement terminates upon full satisfaction and repayment of all Obligations, with certain expressly stated obligations surviving - The Agreement terminates upon full satisfaction and repayment of all Obligations (excluding inchoate indemnification obligations or those expressly surviving)[245](index=245&type=chunk) [SCHEDULES AND EXHIBITS](index=61&type=section&id=SCHEDULES%20AND%20EXHIBITS) This article lists and briefly describes the supporting schedules and exhibits that provide detailed information and forms for the Loan Agreement [COMMITMENTS](index=61&type=section&id=SCHEDULE%201) Schedule 1 details the commitment amounts for each Lender across different loan tranches, totaling the aggregate principal amount available Lender Commitments by Tranche | Lender Name | Tranche A Loan Commitment | Tranche B Loan Commitment | Tranche C Loan Commitment | Tranche D Loan Commitment* | Total* | | :--- | :--- | :--- | :--- | :--- | :--- | | Trinity Capital Inc. | [***] | [***] | [***] | [***] | [***] | | Eagle Point Trinity Senior Secured Lending Company | [***] | [***] | [***] | [***] | [***] | | **Total** | **$50,000,000** | **$20,000,000** | **$30,000,000** | **$30,000,000** | **$130,000,000** | *Funding of Tranche D Loan is subject to approval by Lenders' investment committee in its sole discretion. [AMORTIZATION SCHEDULE](index=62&type=section&id=EXHIBIT%20A) Exhibit A provides the detailed payment schedule for the Tranche A Loan as of the Closing Date, subject to updates by the Administrative Agent - Exhibit A contains the payment schedule for the Tranche A Loan as of the Closing Date, subject to updates by the Administrative Agent[112](index=112&type=chunk)[253](index=253&type=chunk) [SECRETARY'S CERTIFICATE](index=63&type=section&id=EXHIBIT%20B) Exhibit B is the form for the Secretary's Certificate, attesting to Borrower's authorizing resolutions and Operating Documents, required for the Tranche A Loan - Exhibit B is the form for the Secretary's Certificate, required to evidence authorizing resolutions and Operating Documents of Borrower with specimen signatures[123](index=123&type=chunk)[255](index=255&type=chunk) [FORM OF COMPLIANCE CERTIFICATE](index=64&type=section&id=EXHIBIT%20C) Exhibit C provides the template for the Compliance Certificate, used by Borrower's Responsible Officer to certify compliance with loan terms and financial covenants - The Compliance Certificate requires certification that no Potential Events of Default or Events of Default exist, and all representations and warranties are true and correct[258](index=258&type=chunk) - It includes certification of tax filings and payments, absence of unpaid employee payroll/benefit liens, and compliance with financial covenants like minimum Liquidity and MSC Investment Condition[259](index=259&type=chunk)[260](index=260&type=chunk)[266](index=266&type=chunk) Compliance Reporting Covenants | Reporting Covenant | Requirement | | :--- | :--- | | Monthly financial statements | Monthly within 30 days | | Compliance Certificate | Monthly within 30 days | | Annual (CPA Audited) statements | Within 180 days after FYE (or shorter period required by SEC) | | Annual Financial Projections | Within 60 days after FYE | | 8‑K, 10‑K and 10‑Q Filings | At time of filing | | IP Report | Concurrently with Compliance Certificate | | 409A valuation report | Within 30 days of completion | [Loan Advance Request Form](index=69&type=section&id=EXHIBIT%20D) Exhibit D is the form used by the Borrower to request loan advances, specifying amount and destination, and confirming compliance with representations and warranties - The Loan Advance Request Form is used to request loan funds, specifying the amount and destination account[270](index=270&type=chunk) - The form requires certification that all Borrower's representations and warranties in the Loan Agreement will be true, correct, and complete in all material respects on the advance date[270](index=270&type=chunk) [U.S. TAX COMPLIANCE CERTIFICATE (For Foreign Lenders That Are Not Partnerships For U.S. Federal Income Tax Purposes)](index=71&type=section&id=EXHIBIT%20E-1) Exhibit E-1 is a U.S. Tax Compliance Certificate for foreign non-partnership lenders to claim portfolio interest exemption from U.S. federal withholding tax - This certificate is for Non-U.S. Lenders (not partnerships) to certify they are not a bank, 10-percent shareholder, or controlled foreign corporation, for U.S. federal income tax purposes[274](index=274&type=chunk) - It requires the Lender to furnish IRS Form W-8BEN or W-8BEN-E and to promptly update the Borrower and Administrative Agent if the information changes[275](index=275&type=chunk) [U.S. TAX COMPLIANCE CERTIFICATE (For Foreign Participants That Are Not Partnerships For U.S. Federal Income Tax Purposes)](index=72&type=section&id=EXHIBIT%20E-2) Exhibit E-2 is a U.S. Tax Compliance Certificate for foreign non-partnership participants to claim portfolio interest exemption from U.S. federal withholding tax - This certificate is for Non-U.S. Participants (not partnerships) to certify they are not a bank, 10-percent shareholder, or controlled foreign corporation, for U.S. federal income tax purposes[280](index=280&type=chunk) - It requires the Participant to furnish IRS Form W-8BEN or W-8BEN-E to their participating Lender and to promptly update the Lender if the information changes[281](index=281&type=chunk) [U.S. TAX COMPLIANCE CERTIFICATE (For Foreign Participants That Are Partnerships For U.S. Federal Income Tax Purposes)](index=73&type=section&id=EXHIBIT%20E-3) Exhibit E-3 is a U.S. Tax Compliance Certificate for foreign partnership participants to claim portfolio interest exemption from U.S. federal withholding tax - This certificate is for Non-U.S. Participants (partnerships) to certify that neither the partnership nor its partners are banks, 10-percent shareholders, or controlled foreign corporations[286](index=286&type=chunk) - It requires the Participant to furnish IRS Form W-8IMY along with appropriate forms from each partner claiming the portfolio interest exemption[287](index=287&type=chunk) [U.S. TAX COMPLIANCE CERTIFICATE (For Foreign Lenders That Are Partnerships For U.S. Federal Income Tax Purposes)](index=74&type=section&id=EXHIBIT%20E-4) Exhibit E-4 is a U.S. Tax Compliance Certificate for foreign partnership lenders to claim portfolio interest exemption from U.S. federal withholding tax - This certificate is for Non-U.S. Lenders (partnerships) to certify that neither the partnership nor its partners are banks, 10-percent shareholders, or controlled foreign corporations[291](index=291&type=chunk) - It requires the Lender to furnish IRS Form W-8IMY along with appropriate forms from each partner claiming the portfolio interest exemption[292](index=292&type=chunk)

Core Viewpoint - Candel Therapeutics has secured a five-year, $130 million term loan facility with Trinity Capital to enhance its financial position and support the initiation of pivotal clinical trials for its lead product candidate, CAN-2409, in non-small cell lung cancer (NSCLC) and localized prostate cancer [1][2][3]. Financial Details - The loan facility consists of four tranches, with an initial draw of $50 million at closing, and an additional $80 million available based on the achievement of specific milestones [2][6]. - The interest rate on the loan is set at 10.25% per annum, with an interest-only period of 36 months, extendable for an additional 12 months upon meeting certain commercial milestones [2]. Strategic Implications - The financing will allow the company to initiate a pivotal phase 3 clinical trial of CAN-2409 in NSCLC in Q2 2026 and prepare for a potential Biologics License Application submission for prostate cancer in Q4 2026 [3][9]. - Candel Therapeutics aims to focus its resources on early localized prostate cancer and NSCLC, while seeking external partnerships for the development of CAN-2409 in pancreatic ductal adenocarcinoma (PDAC) [3][9]. Clinical Development - Candel has completed successful phase 2a clinical trials for CAN-2409 in both NSCLC and PDAC, and is advancing towards a pivotal phase 3 trial for localized prostate cancer [9]. - The company has received multiple designations from the FDA, including Fast Track and Orphan Drug Designation for CAN-2409 in various indications [9]. Company Overview - Candel Therapeutics is a clinical-stage biopharmaceutical company focused on developing multimodal biological immunotherapies to combat cancer, with its lead product candidate being CAN-2409 from its adenovirus platform [8].

Core Insights - Trinity Capital Inc. has committed $130 million in growth capital to Candel Therapeutics, a clinical-stage biopharmaceutical company focused on viral immunotherapies for cancer treatment [1][4] Company Overview - Candel Therapeutics is developing off-the-shelf cancer treatments that utilize the patient's immune system to combat various cancers, including prostate, pancreatic, lung, and brain cancer [2][6] - The company has received multiple FDA designations for its therapies, including Regenerative Medicine Advanced Therapy Designation and Fast Track Designation for localized prostate cancer and non-small cell lung cancer [2][6] Investment Details - The investment from Trinity Capital will support the clinical development of Candel's lead therapy, CAN-2409, and activities related to its pre-commercialization and launch for prostate cancer, pending regulatory approval [3][4] - This partnership is seen as a pivotal moment for Candel, enhancing its financial position and accelerating the advancement of its innovative therapies [4] Clinical Development - Candel's CAN-2409 has completed successful phase 2a clinical trials for non-small cell lung cancer and pancreatic ductal adenocarcinoma, and is undergoing a pivotal phase 3 trial for localized prostate cancer [6] - CAN-3110, another product candidate, is currently in a phase 1b clinical trial for recurrent high-grade glioma and has received Fast Track and Orphan Drug Designations from the FDA [6] Strategic Positioning - Trinity Capital aims to deliver consistent returns through investments in growth-oriented companies across various sectors, including life sciences, having deployed over $4.7 billion across more than 420 investments since its inception [5]

Core Insights - Candel Therapeutics announced promising interim data from its phase 1b clinical trial of CAN-3110 in recurrent glioblastoma, along with a publication in a high-impact journal [1][2] Clinical Trial Findings - The publication details findings from 97 tumor biopsies from two patients, revealing a discordance between immune biomarkers and imaging results, indicating that conventional imaging may misinterpret immune infiltration as disease progression [3][5] - CAN-3110 induced significant changes in the tumor microenvironment, with one patient achieving a complete pathological response [3][4] - The study identified T cell clonotypes targeting CAN-3110 epitopes, supporting the dual mechanism of action of the therapy [4][5] Survival Data - Updated median overall survival (mOS) was reported as 11.8 months for arm A and 12.0 months for arm B, with some patients surviving significantly longer [5][6] - In arm C, 9 patients received multiple administrations of CAN-3110, with a median follow-up of 8.9 months; 4 out of 9 patients were alive at the time of data cutoff [6] Future Directions - The company plans to design a small phase 2 clinical trial for CAN-3110 in recurrent glioblastoma, collaborating with the glioblastoma community and regulators [8] - CAN-3110 has received FDA Fast Track and Orphan Drug Designations, indicating its potential as a treatment for recurrent high-grade glioma [8][11] Company Overview - Candel Therapeutics focuses on developing multimodal biological immunotherapies, with CAN-3110 being a first-in-class oncolytic viral immunotherapy candidate [9][10] - The company has established platforms based on genetically modified adenovirus and herpes simplex virus, with ongoing clinical trials for other product candidates [10][11]

Core Insights - Candel Therapeutics (NASDAQ: CADL) shows promising results in immunotherapy for pancreatic cancer and is advancing late-stage studies in prostate cancer [1] Company Analysis - The company has demonstrated impressive clinical trial results, particularly in the area of immunotherapy for pancreatic cancer, which may present significant investment opportunities [1] - Late-stage studies in prostate cancer further enhance the company's potential for growth and success in the biotech sector [1] Industry Context - The biotech industry continues to evolve with advancements in immunotherapy, highlighting the importance of thorough analysis and understanding of clinical trials for potential investors [1]

Core Insights - Candel Therapeutics, Inc. is set to present findings from its enLIGHTEN™ Discovery Platform and data from the CAN-2409 program in non-small cell lung cancer (NSCLC) at the Society for Immunotherapy of Cancer's 40th Anniversary Annual Meeting in November 2025 [1][2] Group 1: Clinical Trials and Presentations - Candel will showcase positive phase 3 clinical trial data of CAN-2409 for intermediate-to-high-risk localized prostate cancer during an invited faculty presentation [2][3] - Two poster presentations will occur on November 7, 2025, focusing on the integration of machine learning in cancer immunotherapy and the immune response to CAN-2409 in NSCLC [2][3] Group 2: Product Development and Regulatory Designations - CAN-2409 is the lead candidate from Candel's adenovirus platform, having completed successful phase 2a trials in NSCLC and pancreatic ductal adenocarcinoma (PDAC) [4] - The FDA has granted multiple designations to CAN-2409, including Regenerative Medicine Advanced Therapy Designation for localized prostate cancer and Fast Track Designation for both NSCLC and prostate cancer [4] Group 3: Company Overview and Research Focus - Candel Therapeutics specializes in developing off-the-shelf multimodal biological immunotherapies aimed at eliciting systemic anti-tumor immune responses [4][5] - The company has established two clinical-stage platforms based on genetically modified adenovirus and herpes simplex virus (HSV) gene constructs [4][5]

Group 1 - Proactive provides fast, accessible, informative, and actionable business and finance news content to a global investment audience [2][3] - The company focuses on medium and small-cap markets while also covering blue-chip companies, commodities, and broader investment stories [3] - Proactive's editorial and broadcast operations span six offices across three continents, ensuring a wide reach in financial news coverage [2] Group 2 - The news team at Proactive delivers unique insights across various sectors, including biotech, pharma, mining, natural resources, battery metals, oil and gas, crypto, and emerging technologies [3] - Proactive adopts technology to enhance workflows, utilizing automation and software tools, including generative AI, while ensuring all content is edited and authored by humans [4][5]

Core Insights - CAN-2409 demonstrated improved disease-free survival in patients with intermediate-to-high-risk localized prostate cancer compared to placebo, regardless of the radiation therapy modality used [1][2][5] - The study represents the first significant advancement in localized, non-metastatic prostate cancer treatment in over 20 years [2][5] Clinical Trial Details - The phase 3 clinical trial (NCT01436968) enrolled 745 patients, randomized 2:1 to receive either CAN-2409 plus valacyclovir with standard care or standard care alone [2] - The trial achieved a 30% improvement in disease-free survival (HR 0.7, p=0.0155) and a 38% improvement in prostate cancer-specific disease-free survival (HR 0.62, p=0.0046) [2] - At two years, the pathological complete response rates were 80.4% in the treatment group compared to 63.6% in the control group (p=0.0015) [2] Efficacy and Safety - CAN-2409's efficacy was maintained across different radiation modalities, including moderate hypofractionated radiation, which is more convenient for patients [4][5] - Safety profiles were similar between treatment and control groups, with grade ≥ 3 treatment-related adverse events being comparable [6] Regulatory and Development Plans - The company plans to submit a Biologics License Application for CAN-2409 in Q4 2026 [5] - CAN-2409 has received various designations from the FDA, including Regenerative Medicine Advanced Therapy Designation and Fast Track Designation for multiple cancer types [8]

Core Viewpoint - Candel Therapeutics, Inc. announced the acceptance of an abstract for an oral presentation at the 2025 ASTRO Annual Meeting, focusing on data from its phase 3 clinical trial of CAN-2409 for localized prostate cancer [1][3] Company Overview - Candel Therapeutics is a clinical-stage biopharmaceutical company developing multimodal biological immunotherapies to combat cancer [4] - The company has two clinical-stage platforms based on genetically modified adenovirus and herpes simplex virus (HSV) [4] Clinical Trial Highlights - The phase 3 clinical trial of CAN-2409 for localized prostate cancer was pivotal and placebo-controlled, achieving its primary endpoint along with supportive secondary endpoints [5] - CAN-2409 has received multiple designations from the FDA, including Regenerative Medicine Advanced Therapy Designation for localized prostate cancer and Fast Track Designation for non-small cell lung cancer and pancreatic ductal adenocarcinoma [5] Upcoming Presentation Details - The oral presentation will take place on September 28, 2025, at 2:30 PM PT, featuring the title "Phase 3, Randomized, Placebo Controlled Clinical Trial of CAN-2409+Prodrug in Combination with Standard of Care External Beam Radiation for Newly Diagnosed Localized Prostate Cancer" [9]