Contract analysis

From: Theresa Nakamura <tnakamura@genomedx.com> To: Miriam Calloway <mcalloway@calderwoodharkness.com> Cc: Kevin Driscoll <kdriscoll@genomedx.com> Date: Thu, 23 May 2024 09:47:00 -0000 Subject: Board Decision to Defer OncoPrecise GXP-47 Launch — Wind-Down Instruction (Matter No. 1043-00002)

I am writing to inform you and the Calderwood & Harkness team of a significant decision by the Genome Dx Therapeutics board of directors. At its meeting yesterday, May 22, 2024, the board acted on matters directly affecting the OncoPrecise GXP-47 Medicare coverage and coding engagement (Matter No. 1043-00002), and I want to communicate the outcome and our resulting instructions as promptly as possible.

**Board Decision — Indefinite Deferral of GXP-47 Commercial Launch**

The GDT board of directors unanimously resolved to defer the commercial launch of OncoPrecise GXP-47 indefinitely. The decision was driven by two primary factors:

1. **Inconclusive CLARITY-LUNG Interim Results.** The interim analysis released on March 29, 2024, at 50% enrollment (n=600), showed a positive predictive value (PPV) of 0.68 against a pre-specified threshold of ≥0.75 and a negative predictive value (NPV) of 0.71 against a threshold of ≥0.80. Neither primary endpoint met the pre-specified performance benchmarks. At its April 5, 2024 meeting, the Data Safety Monitorin

2. **Pinnacle Health Ventures' Formal Recommendation.** On May 17, 2024, Elena Marchetti, on behalf of Pinnacle Health Ventures — GDT's largest shareholder at 41.3% of fully diluted equity — formally recommended deferring the GXP-47 launch until final CLARITY-LUNG data is available.

The revised projection for the CLARITY-LUNG final data readout is Q2 2025. Current enrollment stands at 847 of the 1,200-patient target (approximately 70.6%). The board determined that it would be premature to proceed with commercialization activities — including Medicare coverage and coding submissions — in advance of those results. I would note that your team's own Revised LCD/MolDx Strategy Memorandum, delivered A

Accordingly, GDT is instructing Calderwood & Harkness to wind down the engagement effective immediately. Our specific requests are as follows:

1. **Cease All Active Work.** Please cease all active work on the OncoPrecise GXP-47 Medicare coverage and coding strategy, including:

- The draft PLA code application targeted for AMA CPT Editorial Panel submission by the June 28, 2024 deadline (September 2024 meeting) — this application should **not** be submitted; - The draft LCD request letter to Cascade Fiscal Intermediaries, LLC, targeted for August 2024 filing — this should **not** be sent; - The draft MolDx Technical Assessment Dossier (Version 1.0), delivered April 30, 2024 — finalization i

2. **Work Product Preservation Summary.** I would ask that Calderwood & Harkness prepare a comprehensive memorandum summarizing all work product delivered during the engagement, identifying any pending or incomplete deliverables, and outlining recommendations for preservation and potential reactivation of the coverage and coding strategy when — and if — GDT resumes commercialization efforts. Please include an index o

3. **PCNB Covenant Consideration.** As you may appreciate, the launch deferral may have implications for the milestone covenant under Section 7.14 of the Pacific Coast National Bank Revolving Facility Credit Agreement (Ref. PCNB-GDT-RF-2023-0922), which requires GDT to obtain a final Medicare coverage determination for at least one proprietary laboratory developed test by December 31, 2024. We currently have $9.2 mil

4. **Final Invoice.** Please issue a final invoice covering all outstanding fees and disbursements through the completion of the wind-down deliverables described above. GDT has paid Invoices INV-1043-00002-001 ($62,437.50) and INV-1043-00002-002 ($78,747.62) in full. We would appreciate a complete final accounting at your earliest convenience.

5. **Coordination with Other Advisors and Third-Party Communications.** GDT will separately notify Janet Carraway at Carraway Regulatory Advisors and Dr. Nathan Ostroff at Larkfield Health Economics of the deferral decision. I must ask that Calderwood & Harkness **not** communicate the board's decision to any third parties — including Cascade Fiscal Intermediaries or Ridgeline Administrative Services — without GDT's

Miriam, I want to express my sincere appreciation for the quality and thoroughness of your team's work over the past three months. The deliverables — particularly the Coding Strategy Memorandum, the Clinical Evidence Gap Analysis, the Revised LCD/MolDx Strategy Memorandum, and the Reimbursement Rate Analysis — represent an exceptional body of work that will be invaluable when GDT is in a position to reactivate the co

On a personal note, Dr. Anisha Raval asked me to convey the board's thanks to you and your team for the dedication and expertise you have brought to this engagement.

Please give me a call when you have a moment to discuss logistics and timeline for the wind-down deliverables. I am available on my direct line today and tomorrow.

Thank you, Miriam. I look forward to speaking with you.

**Theresa Nakamura** General Counsel & VP of Regulatory Affairs Genome Dx Therapeutics Inc. 4720 Torrey Pines Road, Suite 300 San Diego, CA 92130 Tel: (858) 447-3100 Email: tnakamura@genomedx.com

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