Kyverna Therapeutics Establishes Five-Year Clinical and Commercial Supply Agreement with ElevateBio for miv-cel Manufacturing

Transition from Prior Development Agreement to Expanded Manufacturing Framework

Kyverna Therapeutics has fundamentally restructured its manufacturing relationship with ElevateBio by replacing the Development and Manufacturing Services Agreement established on July 22, 2023—and amended on July 24, 2023—with a new Clinical and Commercial Supply Agreement. This transition reflects the company's evolution from development-stage manufacturing support to a framework designed to support both clinical and commercial-scale production of miv-cel. The prior arrangement, while effective for the company's initial manufacturing needs, did not contain the commercial supply provisions now incorporated into the new agreement.

The shift from a development-focused agreement to one explicitly addressing clinical and commercial supply suggests that Kyverna's development program for miv-cel has progressed to a stage where the company and its manufacturing partner are preparing for potential regulatory approval pathways and the associated manufacturing requirements. This transition is a common milestone for biopharmaceutical companies developing cell therapy products, which typically require specialized manufacturing capabilities and infrastructure. ElevateBio's continued role as the exclusive manufacturing partner indicates confidence in the existing relationship and the manufacturer's ability to scale production.

Five-Year Initial Term with Automatic Renewal and Termination Provisions

The Clinical and Commercial Supply Agreement establishes an initial commitment period of five years, a duration that reflects the typical timeline required for clinical development, regulatory review, and early commercial launch of biotechnology products. The five-year term provides both parties with medium-term planning certainty while allowing for the product's advancement through clinical trials and potential FDA approval. This timeframe is standard in manufacturing partnerships for cell therapy candidates, which require sustained investment in process development and quality assurance infrastructure.

The agreement includes automatic renewal for successive one-year periods unless either party provides advance notice of non-renewal or terminates the agreement upon an uncured material breach by the other party. This structure provides flexibility for both Kyverna and ElevateBio to reassess the commercial relationship following the initial five-year commitment, while maintaining continuity of supply through automatic renewal absent affirmative action by either party. The material breach termination provision ensures that either party has a contractual remedy should the other fail to meet critical obligations.

Minimum Purchase Commitments Tied to Regulatory Milestones

Under the terms of the new agreement, Kyverna has undertaken to order at least certain minimum quantities of miv-cel in specified calendar years and following receipt of FDA approval or other government regulatory authority approval of the product. The filing does not disclose the specific minimum quantities or the timing of these commitments, as the company indicated it intends to seek confidential treatment for certain terms when the full agreement is filed with its next quarterly report. This structure ensures that ElevateBio has predictable demand commitments while protecting Kyverna's commercial flexibility based on the success or timing of regulatory approvals.

The inclusion of milestone-based purchase obligations is typical in manufacturing partnerships for cell therapy products, where regulatory approval is a critical contingency affecting commercial readiness. By tying minimum orders to both calendar year specifications and regulatory approval events, the agreement creates a shared incentive structure: ElevateBio gains visibility into future demand contingent on successful development, while Kyverna secures manufacturing capacity without committing to volume obligations that might precede regulatory approval. This approach balances the capital requirements of both parties during the uncertain pre-approval phase.

Pricing Structure with Annual Inflation Adjustments

The agreement establishes a pricing mechanism in which the Product price and ElevateBio's service fees are subject to annual adjustments based on inflation, with the adjustment capped at a maximum percentage calculated using the Producer Price Index for Pharmaceutical Preparation Manufacturing. This approach ties price escalation to objective, publicly available inflation data specific to the pharmaceutical manufacturing sector, rather than allowing for unlimited pricing increases or requiring ad-hoc renegotiation. The PPI benchmark provides transparency and predictability for Kyverna's manufacturing cost planning while ensuring that ElevateBio is protected against erosion of margins due to inflation in pharmaceutical production inputs.

The filing states that specific prices, fees, and expenses will be detailed in statements of work executed by the parties pursuant to the Agreement. This tiered documentation approach is standard in complex manufacturing arrangements, where master agreements establish the overarching framework and governance, while detailed pricing and technical specifications are codified in individual statements of work. The PPI-based adjustment mechanism provides a mechanism for cost-sharing of inflation impacts without requiring either party to renegotiate pricing annually, reducing administrative burden and potential disputes.

Comprehensive Quality, Testing, and Confidentiality Provisions

The Clinical and Commercial Supply Agreement includes customary acceptance, warranty, quality, testing and inspection, audit, access to information, and confidentiality terms and conditions. These standard provisions are essential in manufacturing partnerships for regulated pharmaceutical products, particularly cell therapies where product quality, batch consistency, and traceability are critical to both regulatory compliance and patient safety. The agreement's inclusion of acceptance procedures establishes mutually understood standards for determining whether manufactured batches meet Kyverna's specifications and regulatory requirements before the company takes possession.

The warranty and quality provisions protect Kyverna against manufacturing defects or failures to meet agreed specifications, while the testing, inspection, and audit rights enable the company to independently verify ElevateBio's compliance with agreed manufacturing standards. The confidentiality provisions protect both parties' proprietary information, manufacturing processes, and commercial data. The filing notes that Kyverna intends to seek confidential treatment for certain terms of the agreement when it is filed with the company's next quarterly report, indicating that sensitive commercial, technical, or manufacturing details will be redacted from the public disclosure.

Incorporation into Future Quarterly Filing and Disclosure Timeline

The full text of the Clinical and Commercial Supply Agreement will be included in Kyverna's Quarterly Report on Form 10-Q for the fiscal quarter ending September 30, 2026. This timing indicates that the agreement will be publicly available in its entirety—subject to any requested confidential treatment—approximately two months after the agreement's execution date of July 23, 2026. Investors seeking detailed information about pricing, specific minimum purchase commitments, technical specifications, and other material terms not disclosed in the current announcement will be able to review the agreement at that time, subject to any redactions granted by the SEC.

The company's intention to seek confidential treatment for certain terms reflects standard practice in biopharmaceutical manufacturing agreements, where pricing structures, volume commitments, specific manufacturing processes, and performance metrics may provide competitive insights if disclosed publicly. The SEC routinely grants such requests when companies demonstrate that disclosure would cause competitive harm, balancing transparency with legitimate business confidentiality interests. The announcement of the agreement's existence and key commercial framework provides investors with material information about Kyverna's manufacturing strategy while preserving commercially sensitive details pending SEC confidential treatment determination.

Joint Announcement and Regulatory Disclosure

On July 27, 2026, Kyverna Therapeutics and ElevateBio issued a joint press release announcing the entry into the Clinical and Commercial Supply Agreement. The joint announcement underscores the significance of the partnership to both parties and provides market confirmation of the manufacturing relationship. The press release was furnished to the SEC as Exhibit 99.1 to the current report and is incorporated by reference, making it part of the official regulatory filing. This disclosure approach is standard for material commercial agreements in the biopharmaceutical sector, where manufacturing partnerships are significant corporate developments affecting investor confidence and product development trajectory.

The filing notes that the information in Item 7.01 of the current report, including the press release, shall not be deemed "filed" for purposes of Section 18 of the Securities Exchange Act and is not otherwise subject to the liabilities applicable to filed information. This technical distinction means that while the press release is part of the regulatory filing, it does not trigger certain statutory liability provisions that attach to formally "filed" documents. Investors should understand that this limitation does not diminish the substantive importance of the announcement; rather, it is a standard regulatory formality that provides limited liability protection for forward-looking statements or disclosures that may later prove to be inaccurate.

Emerging Growth Company Status and Financial Reporting

Kyverna Therapeutics is identified in the filing as an emerging growth company as defined under Securities Act Rule 405 and Securities Exchange Act Rule 12b-2. The company has not elected to use the extended transition period for complying with new or revised financial accounting standards. This status indicates that Kyverna qualifies for certain reduced disclosure requirements and regulatory accommodations available to smaller, earlier-stage public companies. The company's decision not to adopt the extended transition period for accounting standards means that Kyverna will comply with new financial reporting requirements on the same timeline as larger, more established companies.

The emerging growth company designation may be relevant to investors evaluating Kyverna's financial reporting obligations and the potential for changes in disclosure requirements as the company scales. As Kyverna's revenue and public float grow, the company may eventually lose its emerging growth company status, which could trigger additional reporting obligations. The company's proactive decision to maintain standard accounting compliance timelines suggests management's intention to maintain alignment with larger public company reporting standards even before such alignment becomes mandatory.

Manufacturing Partnership in Context of Cell Therapy Development

The Clinical and Commercial Supply Agreement with ElevateBio is a critical component of Kyverna's strategy to advance mivocabtagene autoleucel toward commercialization. Cell therapy manufacturing is capital-intensive, highly specialized, and requires sustained expertise in areas including cell isolation, expansion, transduction, quality control, and cryopreservation. By establishing a five-year manufacturing partnership with defined minimum purchase commitments and inflation-adjusted pricing, Kyverna has secured a foundational element of its commercialization infrastructure. ElevateBio's role as a dedicated contract manufacturing partner allows Kyverna to focus resources on clinical development and regulatory strategy while leveraging specialized manufacturing expertise.

The agreement's inclusion of both clinical and commercial supply provisions reflects the realistic possibility that miv-cel may advance through clinical trials to regulatory approval within the five-year agreement term. Cell therapy products typically require sophisticated manufacturing processes that must be scaled from clinical trial volumes to commercial quantities, a transition that requires careful planning and FDA-approved manufacturing procedures. The minimum purchase commitments tied to regulatory approval mitigate ElevateBio's risk of over-investing in manufacturing capacity while ensuring Kyverna has secured manufacturing supply if the product gains approval.