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MEMORANDUM

PRIVILEGED AND CONFIDENTIAL ATTORNEY-CLIENT PRIVILEGE ATTORNEY WORK PRODUCT

This memorandum has been prepared by Calderwood & Harkness LLP at the request of and for the sole use of its client, Penterra Pharmaceuticals Corp. This memorandum is protected by the attorney-client privilege and the work product doctrine. Any disclosure, copying, or distribution of this memorandum or its contents without the prior written consent of Calderwood & Harkness LLP is strictly prohibited.

TO: Oliver Mackenzie, Partner, Calderwood & Harkness LLP Harrison Wexford, Partner, Calderwood & Harkness LLP

CC: Thomas F. Holbrook, General Counsel, Penterra Pharmaceuticals Corp. Natalie Reiner, SVP Corporate Development, Penterra Pharmaceuticals Corp.

FROM: Megan Chu, Associate, Calderwood & Harkness LLP Derek Okonkwo, Associate, Calderwood & Harkness LLP

DATE: May 20, 2024

RE: Regulatory and FDA Compliance Due Diligence — Veridian Biosciences, Inc.

MATTER NO.: 1018-00008

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I. Executive Summary

This memorandum summarizes the results of our regulatory and FDA compliance due diligence review of Veridian Biosciences, Inc. ("Veridian" or the "Company") in connection with the proposed acquisition by Penterra Pharmaceuticals Corp. ("Penterra" or the "Buyer") of 100% of Veridian's outstanding capital stock (the "Transaction"). The proposed purchase price for the Transaction is $900,000,000 in cash, subject to customary adjustments as set forth in the draft stock purchase agreement currently under negotiation between the parties.

Scope of Review. Our review encompassed the following areas of Veridian's regulatory posture and FDA compliance: (a) all FDA regulatory filings, including Investigational New Drug ("IND") applications and amendments; (b) clinical trial documentation, including clinical protocols, investigator's brochures, data monitoring committee charters and minutes, and clinical trial agreements; (c) all FDA correspondence, including meeting request letters, meeting minutes, information requests, and agency responses; (d) pre-IND meeting materials and End-of-Phase I meeting materials; (e) adverse event reporting and pharmacovigilance documentation, including Individual Case Safety Reports and serious adverse event reports; (f) Good Manufacturing Practice ("GMP"), Good Laboratory Practice ("GLP"), and Good Clinical Practice ("GCP") compliance documentation; and (g) applicable requirements under Title 21 of the Code of Federal Regulations ("21 CFR"), including Parts 11, 50, 56, 58, 210, 211, and 312, as relevant to Veridian's current stage of development. Our review covered the entirety of Veridian's development pipeline, with particular emphasis on the Company's lead candidate, VRD-4187.

Coordination with Scientific Advisors. This memorandum was prepared in coordination with the clinical and scientific due diligence being conducted by Broadleaf Scientific Consulting LLC, under the direction of Dr. Raymond Kapoor, Managing Director. Dr. Kapoor's team is responsible for assessing the clinical and scientific merits of Veridian's pipeline candidates, including the quality and interpretability of clinical trial data. Clinical and scientific assessments are beyond the scope of this legal due diligence memorandum and are addressed separately in Broadleaf's report. Where relevant, we have noted areas of overlap between regulatory and scientific considerations.

Sources Reviewed. In preparing this memorandum, we reviewed the following categories of materials and information:

• Virtual data room materials hosted on the Thackeray Solutions platform, made available by Veridian's legal counsel, Zalcourt Archer & Cole LLP (Rebecca Whitmore, Partner), beginning March 11, 2024. The virtual data room contained approximately 4,200 documents organized across regulatory, clinical, CMC, nonclinical, corporate, intellectual property, and financial categories.

• Supplemental document requests submitted by Calderwood & Harkness LLP on March 28, 2024, April 12, 2024, and April 30, 2024, with responsive documents received and uploaded to the data room through May 15, 2024.

• Management interviews conducted during April 2024, including interviews with: (i) Dr. Julian Marek, Chief Executive Officer and co-founder; (ii) Dr. Priya Chandrasekaran, Chief Scientific Officer and co-founder; and (iii) Dr. Anne-Marie Fontaine, Vice President, Regulatory Affairs. These interviews were conducted via videoconference on April 8, 2024 (Dr. Marek), April 10, 2024 (Dr. Chandrasekaran), and April 15, 2024 (Dr. Fontaine), and addressed regulatory strategy, FDA interactions, clinical trial conduct, safety experience, and manufacturing arrangements.

• Publicly available FDA databases, including the FDA Establishment Registration and Device Listing database, the Debarment List, the FDA Warning Letters database, and the ClinicalTrials.gov registry.

High-Level Findings. Based on our review, we report the following high-level findings:

Veridian is a clinical-stage biotechnology company with no marketed products and no product revenue. For fiscal year ended December 31, 2023, the Company reported total revenue of $0 and a net loss of ($87.3 million). The Company's regulatory posture is centered on three immuno-oncology candidates developed on its proprietary VeriTCE (Veridian T-Cell Engager) bispecific antibody platform. The lead candidate, VRD-4187, a bispecific T-cell engager targeting DLL3-expressing tumors for the treatment of small cell lung cancer ("SCLC"), has an active IND (IND No. 154832) and is currently in a Phase II clinical trial (the Marlowe Asset Management-2 study, ClinicalTrials.gov Identifier NCT05837291). The second pipeline candidate, VRD-5923, is in early clinical development, and the third candidate, VRD-7011, remains in the preclinical stage.

Compliance with applicable FDA regulatory requirements appears to be generally satisfactory across all areas reviewed. We identified no material deficiencies in Veridian's IND filings, clinical trial conduct, safety reporting, or GCP compliance. The Company has received no FDA warning letters, consent decrees, injunctions, or debarment actions. No clinical holds or partial clinical holds have been imposed on any of Veridian's IND applications. The Company's regulatory affairs team is experienced and appropriately staffed for the Company's current stage of development.

Notwithstanding the generally favorable compliance posture, we have identified several key risk factors that warrant attention in the context of the Transaction, which are discussed in detail in Section XIV of this memorandum. These include: (a) the inherent clinical-stage development risk associated with VRD-4187, including the upcoming Phase II interim analysis expected in approximately August 2024; (b) the single-asset concentration of the pipeline, with the vast majority of Veridian's enterprise value attributable to VRD-4187; (c) the known cytokine release syndrome ("CRS") safety signal associated with the bispecific T-cell engager class, which will require ongoing monitoring; (d) the Company's dependency on third-party contract development and manufacturing organizations ("CDMOs") for all manufacturing activities; and (e) inherent uncertainty regarding FDA's future regulatory requirements and standards for approvability. Our specific recommendations regarding the treatment of these risk factors in the definitive transaction documentation are set forth in Section XV.

II. Company Regulatory Overview

A. Company Background

Veridian Biosciences, Inc. is a corporation organized and existing under the laws of the State of Delaware, with its principal office and corporate headquarters located at 550 Gateway Drive, Cambridge, Massachusetts 02142. The Company was founded in 2016 by Dr. Julian Marek and Dr. Priya Chandrasekaran, who currently serve as Chief Executive Officer and Chief Scientific Officer, respectively. Veridian was organized for the purpose of developing novel bispecific T-cell engager immunotherapies for the treatment of solid tumors, leveraging the proprietary VeriTCE antibody engineering platform developed by Drs. Marek and Chandrasekaran during their prior academic research at the Massachusetts Institute of Technology.

Veridian is a clinical-stage biotechnology company. As of the date of this memorandum, the Company has no marketed products and has never received approval from the FDA or any other regulatory authority for the marketing of any pharmaceutical or biological product. The Company does not hold any approved New Drug Applications ("NDAs") or Biologics License Applications ("BLAs"). Accordingly, the Company has generated no product revenue since its inception. For fiscal year 2023, the Company reported total revenue of $0 and a net loss of ($87.3 million), reflecting expenditures primarily attributable to research and development activities, including clinical trial costs, manufacturing costs for clinical supply, and general and administrative expenses. As of March 31, 2024, the Company reported cash and cash equivalents of approximately $112.4 million, which, based on its current operating burn rate, management estimates would fund operations into approximately the first quarter of 2025 absent additional financing or a change-of-control transaction.

The Company employs approximately 148 individuals as of the anticipated signing date of the stock purchase agreement, including scientific, regulatory, clinical operations, manufacturing and supply chain, finance, legal, and administrative personnel. The majority of the Company's employees are located at its Cambridge, Massachusetts headquarters, with a smaller number of employees supporting clinical trial operations remotely.

Since its founding, Veridian has raised approximately $420 million in aggregate through four rounds of venture capital and growth equity financing (Series A through Series D). The Company's principal institutional investors include Crestline Ventures, LP, which holds approximately 28.3% of the Company's outstanding capital stock on a fully diluted basis; Boreal Health Partners Fund III, LP, which holds approximately 19.7%; and Apex Growth Equity Fund II, LP, which holds approximately 14.1%. The remaining equity is held by the Company's founders, management team, employees (through stock option and restricted stock unit grants), and a number of smaller institutional and angel investors. The capitalization table and equity ownership structure are addressed in detail in the Corporate Due Diligence Memorandum dated May 16, 2024.

B. Regulatory Affairs Organization

Veridian's regulatory affairs function is led by Dr. Anne-Marie Fontaine, Vice President, Regulatory Affairs, who has been with the Company since 2018 and reports directly to Dr. Julian Marek, Chief Executive Officer. Dr. Fontaine holds a Pharm.D. degree from the University of Michigan and a Master of Science in Regulatory Science from the University of Southern California. Prior to joining Veridian, Dr. Fontaine spent approximately eleven years in regulatory affairs positions at Pemberton Partners LLC and Camberwell Corporation (now part of Halcyon Industries), where she was involved in multiple IND filings, BLA submissions, and FDA advisory committee proceedings in the oncology therapeutic area. We view Dr. Fontaine's experience and qualifications as a significant asset for the Company's regulatory strategy.

The regulatory affairs team reporting to Dr. Fontaine consists of approximately 12 professionals, organized into the following functional areas:

• IND Management (3 professionals): Responsible for the preparation, submission, and maintenance of IND applications, including IND amendments, annual reports, and safety reports; management of the regulatory dossier; and tracking of FDA correspondence.

• Clinical Operations Regulatory Support (3 professionals): Responsible for providing regulatory guidance to the clinical operations team, including protocol development support, informed consent form review, site regulatory document management, and ClinicalTrials.gov registration and reporting compliance.

• Chemistry, Manufacturing, and Controls (CMC) Regulatory (3 professionals): Responsible for the CMC sections of regulatory filings, including drug substance and drug product specifications, manufacturing process descriptions, stability data, and coordination with CDMOs on regulatory aspects of manufacturing.

• Pharmacovigilance and Drug Safety (3 professionals): Responsible for adverse event reporting, safety database management, signal detection, preparation of IND safety reports (15-day and 7-day expedited reports), and aggregate safety analyses.

In addition to the internal regulatory team, the Company has retained external regulatory consultants for specialized submission activities, including: (i) Ashford Advisors for CMC regulatory strategy consulting and FDA meeting preparation; and (ii) Fenmore Advisory Group for pharmacovigilance database implementation and validation. Engagement letters and scopes of work for these consultants were identified in the data room and reviewed.

Based on our review and our interview with Dr. Fontaine, we believe that the regulatory affairs organization is appropriately structured and staffed for the Company's current stage of development. However, we note that a significant expansion of the regulatory team will likely be necessary as VRD-4187 advances toward a potential BLA submission, and that such expansion planning should be incorporated into Penterra's post-acquisition integration planning.

C. FDA Registration and Establishment Status

Veridian is registered with the FDA as a sponsor of investigational drugs, as required for the submission and maintenance of IND applications under 21 CFR Part 312. The Company's FDA Data Universal Numbering System ("DUNS") number and Facility Establishment Identifier ("FEI") are on file.

Critically, the Company does not hold any FDA facility registrations for pharmaceutical or biological manufacturing. Veridian does not maintain any internal manufacturing capabilities for drug substance or drug product. All manufacturing of VRD-4187 clinical supply, including cell line development, cell culture and fermentation, purification, formulation, and fill/finish, is outsourced to contract development and manufacturing organizations, as discussed in detail in Section VII of this memorandum. As a result, the Company itself has not been subject to FDA establishment inspections or pre-approval inspections. The FDA inspection histories of the CDMO facilities utilized by Veridian are reviewed separately in Section VII.A.

We confirmed through review of the FDA Warning Letters database and the FDA Debarment List that no warning letters, debarment actions, or other enforcement actions have been issued to Veridian Biosciences, Inc. or to any of its officers, directors, or employees as of the date of this memorandum.

III. Pipeline Overview and Regulatory Status of Each Candidate

The following section provides an overview of each of the three product candidates in Veridian's development pipeline and the current regulatory status of each as of May 2024.

A. VRD-4187 (Lead Candidate)

Product Description. VRD-4187 is a bispecific T-cell engager antibody construct developed using Veridian's proprietary VeriTCE platform technology. VRD-4187 is designed to simultaneously bind to DLL3 (Delta-like ligand 3), a protein expressed on the surface of small cell lung cancer tumor cells, and CD3, a component of the T-cell receptor complex on cytotoxic T lymphocytes. By creating a bridge between DLL3-expressing tumor cells and T cells, VRD-4187 is intended to redirect the patient's own immune system to recognize and destroy tumor cells. DLL3 is an attractive target for SCLC because it is highly expressed on SCLC tumor cells but has limited expression on normal adult tissues, which is intended to minimize off-target toxicity.

SCLC is an aggressive form of lung cancer that accounts for approximately 10-15% of all lung cancers and is characterized by rapid growth, early metastasis, and poor prognosis. The five-year survival rate for extensive-stage SCLC is less than 5%. Treatment options for relapsed or refractory SCLC are limited, and there remains a significant unmet medical need for novel therapeutic approaches. VRD-4187 is being developed initially for the treatment of patients with extensive-stage SCLC who have progressed after first-line platinum-based chemotherapy.

IND Number. IND 154832.

IND Filing Date. The original IND application for VRD-4187 was submitted to the FDA on June 14, 2021. The FDA's 30-day safety review period expired on July 14, 2021, without the imposition of a clinical hold, and the IND became effective on that date. The Company initiated its first-in-human Phase I clinical trial (Study VRD-4187-001, also referred to as the "Marlowe Asset Management-1" study) in August 2021.

Current Regulatory Status as of May 2024. IND 154832 is in active status. The Phase I dose-escalation and dose-expansion study (Marlowe Asset Management-1) has been completed. The Company's lead registrational study, a randomized, open-label Phase II clinical trial designated as the "Marlowe Asset Management-2" study, was initiated in March 2023 and is currently enrolling and treating patients.

Clinical Trial — Marlowe Asset Management-2. The Marlowe Asset Management-2 study is a randomized, open-label, multicenter Phase II clinical trial evaluating the efficacy and safety of VRD-4187 compared to investigator's choice of chemotherapy (topotecan or irinotecan) in patients with extensive-stage SCLC who have progressed after first-line platinum-based chemotherapy. The study is registered on ClinicalTrials.gov under Identifier NCT05837291.

Key details of the Marlowe Asset Management-2 study are as follows:

• Study Design: Randomized (1:1), open-label, active-controlled, multicenter Phase II trial.

• Study Sites: 42 clinical trial sites across the United States (28 sites) and the European Union (14 sites, located in Germany, France, Spain, the Netherlands, and Italy).

• Enrollment: As of the most recent enrollment update available in the data room (dated April 30, 2024), 387 patients have been enrolled and randomized, including 194 patients in the VRD-4187 treatment arm and 193 patients in the investigator's choice control arm. Target enrollment for the study is 450 patients.

• Primary Endpoint: Overall response rate ("ORR"), as assessed by independent central review using RECIST v1.1 criteria.

• Key Secondary Endpoints: Progression-free survival ("PFS"), overall survival ("OS"), duration of response ("DOR"), and safety and tolerability.

• Data Monitoring Committee: An independent Data Monitoring Committee ("DMC") has been established and is responsible for ongoing safety monitoring throughout the trial. The DMC charter, membership, and meeting minutes are discussed in Section IV.E.

• Interim Analysis: The clinical protocol provides for a pre-planned interim analysis of efficacy and safety data to be conducted by the DMC when approximately 75% of the expected ORR events have been observed. Based on current enrollment and follow-up timelines, the interim analysis is anticipated to occur in approximately Q3 2024 (estimated August 2024). The implications of this interim analysis for the Transaction are discussed in Section XIV.B.

• Current Status: The trial is ongoing. No interim data readout has yet occurred as of the date of this memorandum. The Company expects to complete enrollment by approximately July 2024 and anticipates the interim analysis in approximately August 2024, with potential topline results from the primary endpoint analysis available in late 2024 or early 2025.

Dosing and Protocol. The current dosing regimen for VRD-4187 in the Marlowe Asset Management-2 study, as specified in the clinical protocol (Protocol Version 3.2, dated January 22, 2024), employs a step-up dosing approach. Patients receive a starting dose of 0.5 mg/kg on Day 1, followed by escalation to 1.0 mg/kg on Day 8, and then to the target dose of 1.5 mg/kg on Day 15 and every two weeks thereafter. This step-up dosing regimen was developed to mitigate the risk and severity of cytokine release syndrome, based on the safety experience from the Phase I Marlowe Asset Management-1 study. The protocol includes detailed dose modification and de-escalation rules for the management of CRS and other adverse events, as well as specific guidance on the administration of prophylactic medications (including dexamethasone premedication) and the availability of tocilizumab at clinical trial sites for the treatment of CRS. We reviewed the current protocol (Version 3.2) and all prior versions (Versions 1.0, 2.0, 2.1, and 3.0) in the data room.

Regulatory Milestones Achieved. The following key regulatory milestones have been achieved for VRD-4187:

1. Pre-IND Meeting (Type B): Conducted on March 3, 2021 (discussed in Section V.A).

2. IND Submission: June 14, 2021.

3. IND Effective (no clinical hold): July 14, 2021.

4. Phase I Initiation (Marlowe Asset Management-1): August 2021.

5. Phase I Completion: December 2022.

6. End-of-Phase I Meeting (Type B): Conducted on January 24, 2023 (discussed in Section V.B).

7. Phase II Initiation (Marlowe Asset Management-2): March 2023.

Clinical Hold Status. As of the date of this memorandum, there are no clinical holds or partial clinical holds on IND 154832. The IND has been in continuous active status since it became effective on July 14, 2021, and has not at any time been subject to a full or partial clinical hold.

B. VRD-5923 (Pipeline Candidate #2)

Product Description. VRD-5923 is a bispecific T-cell engager antibody construct also developed on the VeriTCE platform. VRD-5923 targets a different tumor-associated antigen, CLDN18.2 (Claudin 18.2), which is expressed in gastric and gastroesophageal junction cancers. VRD-5923 employs the same bispecific architecture as VRD-4187, engaging both the tumor target (CLDN18.2) and CD3 on T cells to mediate tumor cell killing.

IND Number and Status. IND 167514 was submitted to the FDA on February 9, 2024. The 30-day safety review period expired on March 11, 2024, and the IND became effective without the imposition of a clinical hold. As of the date of this memorandum, VRD-5923 is in the early stages of a Phase I dose-escalation study (Study VRD-5923-001) that was initiated at two clinical trial sites in the United States in April 2024. The Phase I study is designed to evaluate the safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity of VRD-5923 in patients with CLDN18.2-positive advanced gastric or gastroesophageal junction adenocarcinoma. Enrollment in the Phase I study is in its early stages, with fewer than 10 patients enrolled as of the date of this memorandum.

Regulatory Interactions. A pre-IND meeting (Type B) for VRD-5923 was conducted with the FDA on September 12, 2023. Meeting minutes were reviewed in the data room. The FDA provided generally supportive feedback on the proposed Phase I study design, nonclinical package, and CMC strategy. The FDA recommended that Veridian consider incorporating correlative biomarker assessments to characterize the immune response and tumor microenvironment, which Veridian has incorporated into the Phase I protocol. No material disagreements with FDA were identified in the meeting minutes.

VRD-5923 is in a very early stage of clinical development and contributes a relatively modest portion of the overall regulatory profile under review. Detailed clinical and efficacy assessments for VRD-5923 are being addressed by Broadleaf Scientific Consulting LLC in their separate report.

C. VRD-7011 (Pipeline Candidate #3)

Product Description. VRD-7011 is a third bispecific T-cell engager construct on the VeriTCE platform, targeting MSLN (Mesothelin), a tumor-associated antigen expressed in mesothelioma, ovarian cancer, and pancreatic cancer. VRD-7011 is being developed as a potential treatment for malignant pleural mesothelioma.

Regulatory Status. VRD-7011 is in the preclinical stage of development. No IND application has been filed for VRD-7011 as of the date of this memorandum. The Company has completed certain in vitro and in vivo pharmacology studies and has initiated IND-enabling Good Laboratory Practice toxicology studies. Based on our interview with Dr. Fontaine, the Company anticipates submitting a pre-IND meeting request to the FDA for VRD-7011 in approximately Q4 2024, with a potential IND submission in the first half of 2025, subject to the completion of GLP toxicology studies and manufacturing process development.

Regulatory Interactions. No formal regulatory interactions with the FDA have occurred for VRD-7011 as of the date of this memorandum. The Company has not submitted a pre-IND meeting request, and no FDA feedback has been obtained. However, the data room contained internal regulatory strategy documents prepared by Dr. Fontaine's team outlining the proposed nonclinical development plan and anticipated IND filing strategy for VRD-7011, which we reviewed.

VRD-7011 is at a very early stage and does not materially contribute to the current regulatory due diligence assessment. However, we note that Veridian's intellectual property rights in the VeriTCE platform technology, which underpins all three pipeline candidates, are a critical asset of the Company and are addressed in the IP Due Diligence Memorandum dated May 14, 2024.

IV. Detailed IND Review — VRD-4187 (IND 154832)

A. IND Submission and Acceptance

The original IND application for VRD-4187 (IND 154832) was submitted to the FDA's Center for Biologics Evaluation and Research ("CBER") on June 14, 2021. The IND was submitted to CBER, rather than the Center for Drug Evaluation and Research ("CDER"), because VRD-4187 is a bispecific antibody construct that is expected to be regulated as a biological product under the Public Health Service Act ("PHSA") and, upon approval, would be the subject of a Biologics License Application ("BLA") rather than a New Drug Application ("NDA"). The IND was assigned to the Office of Tissues and Advanced Therapies within CBER, under review division oversight.

The FDA's 30-day safety review period, as prescribed by 21 CFR § 312.40(b)(1), commenced upon receipt of the IND submission and expired on July 14, 2021. The FDA did not impose a clinical hold during the 30-day review period, and the IND accordingly became effective by operation of the regulation on July 14, 2021, permitting the Company to initiate its Phase I clinical trial.

We reviewed the original IND submission package as contained in the data room. The IND included the following principal components, consistent with the requirements of 21 CFR § 312.23:

• Form FDA 1571 (Investigational New Drug Application cover form), properly executed by Dr. Julian Marek as the sponsor's authorized representative.

• Table of Contents and general investigational plan, describing the proposed Phase I dose-escalation study and the overall clinical development strategy for VRD-4187 in SCLC.

• Investigator's Brochure (Version 1.0, dated May 2021), containing a comprehensive summary of the physical, chemical, pharmaceutical, pharmacological, toxicological, pharmacokinetic, and clinical information known about VRD-4187 at the time of filing.

• Clinical Protocol (VRD-4187-001, Version 1.0, dated May 2021) for the Phase I Marlowe Asset Management-1 dose-escalation and dose-expansion study.

• CMC Section, including information on the drug substance (description of the bispecific antibody construct, manufacturing process, characterization, specifications, and reference standards) and drug product (formulation, manufacturing process, container closure system, specifications, and stability data).

• Pharmacology and Toxicology Section, including the results of nonclinical pharmacology studies (in vitro binding and cytotoxicity assays, in vivo efficacy studies in xenograft models), pharmacokinetic studies, and GLP-compliant toxicology studies (repeat-dose toxicity study in cynomolgus monkeys, tissue cross-reactivity study).

• Previous Human Experience Section: Not applicable (first-in-human study).

The IND submission appeared to be complete, well-organized, and consistent with the requirements of 21 CFR § 312.23 and applicable FDA guidance documents. The absence of a clinical hold during the 30-day review period indicates that the FDA did not identify safety concerns that would have prevented the initiation of clinical trials.

B. IND Amendments and Supplements

We reviewed all IND amendments and supplements filed for IND 154832 from the original submission date through May 15, 2024. The following is a chronological summary of the principal amendment categories:

Protocol Amendments. A total of seven protocol amendments have been filed for IND 154832 since the original IND submission, covering both the Phase I Marlowe Asset Management-1 study and the Phase II Marlowe Asset Management-2 study:

1. Protocol Amendment 1 (August 2021): VRD-4187-001, Version 1.1 — Minor administrative corrections to the Phase I protocol; no substantive changes to study design or dosing.

2. Protocol Amendment 2 (January 2022): VRD-4187-001, Version 2.0 — Modification of the Phase I dose-escalation scheme to incorporate a step-up dosing approach for the higher dose cohorts (≥1.0 mg/kg) based on emerging CRS data from the initial dose cohorts. This amendment was filed as a result of early safety observations indicating that more rapid dose escalation was associated with higher rates of Grade ≥2 CRS. The step-up dosing approach subsequently became the basis for the Phase II dosing regimen.

3. Protocol Amendment 3 (June 2022): VRD-4187-001, Version 2.1 — Addition of a dose-expansion cohort at the 1.5 mg/kg target dose level to further characterize the safety and preliminary efficacy of VRD-4187 at the recommended Phase II dose.

4. Protocol Amendment 4 (February 2023): Submission of the Phase II clinical protocol (VRD-4187-002, Marlowe Asset Management-2, Version 1.0), providing for the randomized, open-label Phase II study design.

5. Protocol Amendment 5 (July 2023): VRD-4187-002, Version 2.0 — Addition of three additional clinical trial sites in the European Union; modification of the exclusion criteria to permit enrollment of patients with treated, stable brain metastases; clarification of CRS grading and management algorithms.

6. Protocol Amendment 6 (November 2023): VRD-4187-002, Version 3.0 — Revision of the statistical analysis plan to reflect updated assumptions regarding ORR based on emerging Phase I efficacy data; update to the DMC charter to clarify the interim analysis trigger and futility boundary.

7. Protocol Amendment 7 (January 2024): VRD-4187-002, Version 3.2 — Minor modifications to the informed consent form to reflect updated safety information from the investigator's brochure; addition of a patient-reported outcome questionnaire.

We note that the modification to the dose-escalation scheme in Protocol Amendment 2 was a significant and proactive safety measure taken by Veridian in response to real-time clinical data. This demonstrates appropriate sponsor vigilance in monitoring safety data and modifying the clinical protocol to protect patient safety. The FDA did not impose a clinical hold in connection with the CRS observations that prompted this protocol amendment, and the step-up dosing approach has been accepted by the FDA as the basis for the Phase II dosing regimen.

Information Amendments. The Company filed approximately 14 information amendments under 21 CFR § 312.31 during the review period, including updates to the investigator's brochure (Versions 2.0, 3.0, 3.1, and 4.0), updated lists of clinical investigators, and notification of new clinical trial sites. All information amendments reviewed appeared to be filed in a timely manner and in compliance with regulatory requirements.

IND Safety Reports. IND safety reports are discussed in detail in Section IV.D below.

CMC Supplements. The Company filed approximately eight CMC-related amendments, including: (i) notification of a change from the original drug substance CDMO (discussed in Section VII); (ii) updated drug substance manufacturing process descriptions reflecting process optimization; (iii) revised drug product specifications; (iv) updated stability data supporting extended shelf life; and (v) qualification of a new drug product fill/finish facility. We reviewed each CMC supplement for completeness and noted no material issues.

Annual Reports. The Company filed IND annual reports for IND 154832 under 21 CFR § 312.33 for the following reporting periods: (i) Year 1 (July 14, 2021 – July 13, 2022), filed on September 28, 2022; (ii) Year 2 (July 14, 2022 – July 13, 2023), filed on September 15, 2023; and (iii) Year 3 (July 14, 2023 – July 13, 2024), expected to be filed in approximately September 2024 (not yet due as of the date of this memorandum). We reviewed the two filed annual reports for completeness and timeliness. Both annual reports were filed within the 60-day window following the anniversary of the IND effective date, as required by 21 CFR § 312.33(a). The reports contained required information regarding the status of each clinical study, updated safety information, summary of IND amendments filed, an update on the general investigational plan, and a log of outstanding business with FDA. We noted no material deficiencies in the annual reports.

C. FDA Correspondence

We reviewed all FDA correspondence contained in the data room related to IND 154832, including outgoing correspondence from Veridian to the FDA and incoming correspondence from the FDA to Veridian. In total, we reviewed approximately 68 items of FDA correspondence spanning the period from March 2021 (initial pre-IND meeting request) through May 2024.

The correspondence reviewed included the following categories:

• Meeting Requests and Meeting Minutes: Discussed in Section V.

• FDA Acknowledgment Letters: Standard FDA acknowledgment letters confirming receipt of IND amendments, safety reports, and annual reports.

• FDA Information Requests: The FDA issued three information requests to Veridian during the review period: (i) a December 2021 request for additional characterization data regarding VRD-4187 drug substance impurity profiles, which was addressed by Veridian in a CMC amendment filed in February 2022; (ii) a June 2022 request for clarification regarding the Phase I dose-escalation stopping rules following the implementation of step-up dosing, which was addressed by Veridian in a protocol amendment filed in July 2022; and (iii) a March 2024 request for updated stability data for drug product stored under the revised storage conditions, which was addressed by Veridian in a CMC amendment filed in April 2024. All three information requests were responded to within the timeframes requested by the FDA, and the FDA did not issue follow-up requests or express dissatisfaction with the responses.

• Veridian Responses to FDA: Responses to the information requests described above, as well as responses to various administrative communications.

No refusal-to-file letters, clinical hold letters, untitled letters, warning letters, or other enforcement-related communications from the FDA were identified in the data room. The FDA correspondence reviewed was consistent with routine regulatory interactions for a clinical-stage IND.

We note that Veridian's regulatory strategy documents reference the following FDA guidance documents as informing the Company's development approach for VRD-4187:

• FDA Guidance for Industry: Bispecific Antibody Development Programs (Draft Guidance, May 2021).

• FDA Guidance for Industry: Expedited Programs for Serious Conditions — Drugs and Biologics (May 2014).

• FDA Guidance for Industry: Clinical Trial Endpoints for the Approval of Cancer Drugs and Biologics (December 2018).

• FDA Guidance for Industry: Cytokine Release Syndrome in Patients Treated with Bispecific T-Cell Engaging Therapies — Grading and Management (Draft Guidance, March 2023).

D. Safety Reporting and Pharmacovigilance

We conducted a detailed review of Veridian's safety reporting procedures, adverse event documentation, and pharmacovigilance systems in connection with VRD-4187 clinical trials.

Safety Reporting Procedures. Veridian has established standard operating procedures ("SOPs") for the reporting of safety information to the FDA in compliance with 21 CFR § 312.32. The Company's pharmacovigilance SOPs address: (a) the collection, processing, and evaluation of adverse event reports from clinical trial investigators; (b) the determination of expectedness and seriousness of adverse events by reference to the investigator's brochure; (c) the preparation and submission of IND safety reports to the FDA, including 15-calendar-day reports for serious and unexpected suspected adverse reactions and 7-calendar-day reports for unexpected fatal or life-threatening suspected adverse reactions; (d) notification of clinical investigators of safety information; and (e) aggregate safety data analysis and signal detection. We reviewed the relevant SOPs and found them to be consistent with regulatory requirements and industry best practices.

Individual Case Safety Reports (ICSRs) / MedWatch Submissions. We reviewed the Company's safety database, which is maintained using the Ridgeline Industries Argus Safety system (validated in accordance with 21 CFR Part 11 requirements, as discussed in Section IX.B). The database contains all adverse event reports from the Phase I Marlowe Asset Management-1 study and the ongoing Phase II Marlowe Asset Management-2 study. Veridian's pharmacovigilance team processes incoming adverse event reports from clinical trial investigators, evaluates them for seriousness, expectedness, and causality, and prepares IND safety reports for submission to the FDA as applicable.

Serious Adverse Event (SAE) Reporting. We reviewed a sample of IND safety reports submitted by Veridian to the FDA for VRD-4187. During the Phase I Marlowe Asset Management-1 study (which enrolled a total of 78 patients), the Company filed 23 IND safety reports, of which 19 were 15-calendar-day expedited reports for serious and unexpected suspected adverse reactions and 4 were 7-calendar-day reports for unexpected fatal or life-threatening suspected adverse reactions. We reviewed a representative sample of these reports for compliance with the timing and content requirements of 21 CFR § 312.32 and noted no instances of late reporting. All reports appeared to contain the required minimum information (identifiable patient, identifiable reporter, suspected drug, and adverse event) and were submitted within the applicable reporting timeframes.

For the Phase II Marlowe Asset Management-2 study (387 patients enrolled as of April 30, 2024), the Company has filed 41 IND safety reports through May 15, 2024, of which 36 were 15-calendar-day reports and 5 were 7-calendar-day reports. We reviewed a representative sample and again noted compliance with timing and content requirements.

Adverse Events of Special Interest. The investigator's brochure for VRD-4187 (Version 4.0, dated December 2023) identifies the following adverse events of special interest for the compound:

(a) Cytokine Release Syndrome (CRS)

(b) Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS)

(d) Tumor lysis syndrome

(e) Infection and neutropenia

Of these, CRS is the most clinically significant and is recognized as a known class effect of bispecific T-cell engager therapies. CRS results from the massive release of cytokines by activated T cells upon engagement of the bispecific antibody with target cells and is characterized by fever, hypotension, hypoxia, and, in severe cases, multi-organ dysfunction. CRS has been a significant clinical challenge in the development of other bispecific T-cell engagers, including blinatumomab (Blincyto) and teclistamab (Tecvayli).

CRS Safety Data Review. Based on our review of the aggregate safety data available in the data room from the Phase I Marlowe Asset Management-1 study, CRS was reported in approximately 62% of patients (48 of 78), with the following grading distribution (using the Lee criteria, as specified in the protocol):

The overall CRS rate of 62% and the Grade ≥3 rate of approximately 9% are within the ranges that have been reported for other approved bispecific T-cell engager therapies targeting CD3. Importantly, the implementation of the step-up dosing approach in Protocol Amendment 2 substantially reduced the incidence and severity of CRS in later dose cohorts compared to earlier cohorts that used a more rapid escalation schedule. The Company reported that no treatment-related deaths attributable to CRS occurred in the Phase I study, and all CRS events resolved with appropriate management (including tocilizumab administration in Grade ≥2 cases and corticosteroid administration in refractory cases).

We note, however, that the Phase II Marlowe Asset Management-2 study is enrolling a larger and more diverse patient population than the Phase I study, including patients at 42 sites with varying levels of experience in managing CRS. The Phase II safety data set is not yet mature and has not been subject to an interim analysis. Accordingly, the CRS safety profile in the Phase II population remains an area of ongoing monitoring and a key risk factor, as discussed in Section XIV.C.

Mitigation Strategies. The clinical protocol for Marlowe Asset Management-2 incorporates the following CRS mitigation strategies, which were reviewed and noted:

(i) Step-up dosing regimen (0.5 mg/kg → 1.0 mg/kg → 1.5 mg/kg) over the first three treatment cycles.

(ii) Mandatory dexamethasone premedication prior to each dose during the step-up period.

(iii) Mandatory availability of tocilizumab at each clinical trial site prior to the administration of VRD-4187.

(iv) Required 24-hour inpatient observation following administration of the first and second doses.

(v) Detailed CRS grading, management, and dose modification algorithms in the protocol, including dose de-escalation and treatment discontinuation criteria.

(vi) Required investigator training on CRS recognition and management prior to site activation.

E. Data Monitoring Committee

We reviewed the DMC charter (Version 2.0, dated October 2023) and the minutes of all DMC meetings held through the date of this memorandum. The DMC for the Marlowe Asset Management-2 study is composed of five independent members, including three medical oncologists with expertise in thoracic malignancies, one biostatistician, and one clinical pharmacologist. None of the DMC members have financial relationships with Veridian or conflicts of interest that would compromise their independence.

The DMC charter provides that the DMC is responsible for: (a) ongoing safety monitoring of the Marlowe Asset Management-2 trial; (b) review of unblinded safety and efficacy data at scheduled interim analyses; (c) authority to recommend modifications to the trial protocol, temporary suspension of enrollment, or termination of the trial based on safety or efficacy considerations; and (d) communication of recommendations to the sponsor. The DMC operates under a pre-specified statistical analysis plan that defines the interim analysis trigger, the efficacy futility boundary, and the safety stopping rules.

Since the initiation of the Marlowe Asset Management-2 study, the DMC has convened four scheduled meetings (in June 2023, October 2023, February 2024, and May 2024) and no unscheduled emergency meetings. We reviewed the minutes of all four meetings. At each meeting, the DMC reviewed aggregate safety data, including CRS rates, SAE rates, and treatment-related adverse event summaries. At all four meetings, the DMC recommended continuation of the trial without modification. No safety alerts, enrollment suspensions, protocol modifications, or trial termination recommendations have been issued by the DMC as of the date of this memorandum.

Upcoming Interim Analysis. The protocol-specified interim analysis is the next critical milestone for the Marlowe Asset Management-2 study. The interim analysis is triggered when approximately 75% of the expected events for the primary ORR endpoint have been observed. Based on current enrollment and follow-up timelines, the Company and the DMC anticipate that the interim analysis trigger will be reached in approximately August 2024. At the interim analysis, the DMC will review unblinded efficacy and safety data and will have the authority to: (i) recommend continuation of the trial without modification; (ii) recommend modification of the trial design or dosing; (iii) recommend suspension of enrollment; or (iv) recommend termination of the trial for futility or safety reasons.

Risk Flag. The DMC interim analysis scheduled for approximately August 2024 represents a critical inflection point for VRD-4187 and for Veridian's enterprise value. Adverse results from the interim analysis — including evidence of insufficient efficacy (failure to meet the futility boundary), an unacceptable safety profile (elevated rates of Grade ≥3 CRS, treatment-related mortality, or other serious adverse events), or a DMC recommendation to modify, suspend, or terminate the trial — could materially and adversely affect the regulatory and commercial outlook for VRD-4187. Given the single-asset concentration of Veridian's pipeline (discussed in Section XIV.D), such adverse results could fundamentally alter the value proposition underlying the Transaction.

We strongly recommend that the definitive stock purchase agreement address the implications of the interim analysis and adverse interim data as follows: (a) the material adverse effect definition should specifically contemplate adverse clinical trial results and DMC recommendations; (b) the closing conditions should include a bring-down of the Seller's representations regarding the regulatory status of VRD-4187 (including the absence of clinical holds and the continuation of the trial in accordance with the protocol); and (c) the operating covenants should require prompt notification to Penterra of any DMC recommendations or FDA communications that could affect the trial. These recommendations are discussed further in Section XV.

V. Pre-IND Meeting and FDA Interactions

A. Pre-IND Meeting — VRD-4187

Veridian conducted a pre-IND meeting (Type B meeting) with the FDA regarding VRD-4187 on March 3, 2021. The meeting request was submitted on December 15, 2020, in accordance with FDA's meeting management procedures, and the briefing document was submitted on February 3, 2021. The meeting was conducted via teleconference with representatives from FDA's Office of Tissues and Advanced Therapies within CBER.

We reviewed the meeting request letter, the briefing document, and the official FDA meeting minutes (dated March 22, 2021) in the data room. The key topics discussed and FDA's feedback included:

Proposed Clinical Development Plan. Veridian presented a proposed Phase I/II clinical development strategy for VRD-4187 in relapsed/refractory extensive-stage SCLC. The FDA generally agreed with the proposed Phase I dose-escalation study design and recommended that Veridian consider incorporating pharmacokinetic and pharmacodynamic biomarker assessments into the Phase I study to inform dose selection for the Phase II study.

Nonclinical Package. The FDA reviewed the proposed nonclinical data package and confirmed that the completed and planned nonclinical studies (including the GLP-compliant repeat-dose toxicity study in cynomolgus monkeys) would be adequate to support the IND submission, provided that the final study reports were available at the time of IND filing. The FDA noted that because VRD-4187 is a species-specific bispecific antibody (binding to human DLL3 and human CD3), the cynomolgus monkey was an appropriate and relevant animal species for toxicology assessment.

CMC Strategy. The FDA provided feedback on the proposed CMC strategy for the IND, including recommendations regarding drug substance characterization, impurity specifications, and the need for comparability assessments in the event of manufacturing process changes.

CRS Risk Management. The FDA specifically raised the topic of CRS risk management, referencing the known CRS safety profile of the blinatumomab (bispecific T-cell engager) class. The FDA recommended that Veridian incorporate detailed CRS grading, management, and dose modification algorithms into the Phase I clinical protocol, and that Veridian consider a step-up dosing approach to mitigate CRS risk. Veridian's subsequent adoption of the step-up dosing approach in Protocol Amendment 2 was consistent with this FDA recommendation.

Areas of Alignment and Divergence. Based on our review of the meeting minutes and subsequent regulatory filings, Veridian's clinical development program for VRD-4187 has been generally aligned with the FDA's pre-IND meeting feedback. We identified one area where Veridian's approach diverged from an FDA suggestion: the FDA suggested that Veridian consider a randomized, placebo-controlled Phase II design, whereas Veridian elected to proceed with a randomized, open-label, active-controlled design (with investigator's choice of chemotherapy as the comparator arm). Veridian discussed this design decision with the FDA at the End-of-Phase I meeting (discussed below), and the FDA did not object to the active-controlled design.

B. End-of-Phase I Meeting

Veridian conducted an End-of-Phase I meeting (Type B meeting) with the FDA on January 24, 2023, following the completion of the Phase I Marlowe Asset Management-1 study. The meeting request was submitted on October 18, 2022, and the briefing document was submitted on January 4, 2023. The meeting was conducted via teleconference.

We reviewed the meeting request letter, the briefing document, and the official FDA meeting minutes (dated February 14, 2023). The key topics discussed included:

Phase II Study Design. Veridian presented the proposed Phase II Marlowe Asset Management-2 study design, including the randomized, open-label, active-controlled design with ORR as the primary endpoint. The FDA agreed that ORR, as assessed by independent central review using RECIST v1.1, was an acceptable primary endpoint for a Phase II study in relapsed/refractory SCLC, noting that ORR has been accepted as a basis for accelerated approval in this indication. The FDA recommended that Veridian also collect overall survival data as a secondary endpoint to support a potential confirmatory benefit. Veridian incorporated OS as a key secondary endpoint in the Marlowe Asset Management-2 protocol.

Dose Selection. The FDA agreed with Veridian's selection of the 1.5 mg/kg target dose (with step-up dosing) as the recommended Phase II dose, based on the totality of the Phase I safety and efficacy data.

Patient Population. The FDA agreed with the proposed patient population (extensive-stage SCLC, second-line or later). The FDA recommended that Veridian consider enrolling patients with treated, stable brain metastases, noting the high incidence of brain metastases in SCLC and the importance of generating data in this patient population. Veridian subsequently amended the protocol (Protocol Amendment 5, Version 2.0) to permit enrollment of patients with treated, stable brain metastases.

Special Protocol Assessment (SPA). We specifically reviewed whether Veridian requested or obtained a Special Protocol Assessment from the FDA for the Marlowe Asset Management-2 study. Based on our review of the data room documents and our interview with Dr. Fontaine, Veridian did not submit an SPA request for Marlowe Asset Management-2. Dr. Fontaine stated that the Company determined that an SPA was not necessary or advisable at the Phase II stage because: (i) the Marlowe Asset Management-2 study is designed as a Phase II study supporting a potential accelerated approval based on ORR, not as a Phase III confirmatory study; and (ii) the Company intends to discuss the design of a confirmatory Phase III study with the FDA following the Phase II data readout, at which point an SPA may be pursued. We note that the absence of an SPA means that the FDA has not formally agreed to the adequacy of the Marlowe Asset Management-2 study design for a specific regulatory purpose, and the FDA retains discretion to require additional clinical data or a different study design to support a BLA submission. This is a relevant consideration for Penterra's assessment of regulatory risk.

C. Other FDA Interactions

Breakthrough Therapy Designation (BTD). We reviewed whether Veridian applied for or received Breakthrough Therapy Designation for VRD-4187. Based on our review of the data room and our interview with Dr. Fontaine, Veridian submitted a request for Breakthrough Therapy Designation for VRD-4187 for the treatment of extensive-stage SCLC to the FDA on April 15, 2023, following the completion of the Phase I study. The FDA denied the BTD request on July 3, 2023, stating that while the preliminary clinical data were encouraging, the data were insufficient to demonstrate a substantial improvement over existing therapies at that early stage of development. Veridian intends to re-submit the BTD request following the availability of Phase II data. The denial of the initial BTD request is not unusual for early-stage programs and does not, in our assessment, reflect a negative regulatory signal; however, it does mean that VRD-4187 does not currently benefit from the enhanced FDA engagement and rolling review features associated with BTD.

Fast Track Designation. Veridian was granted Fast Track Designation for VRD-4187 for the treatment of extensive-stage SCLC by the FDA on September 22, 2021. Fast Track Designation provides Veridian with the opportunity for more frequent interactions with the FDA and eligibility for rolling review of a future BLA submission. The Fast Track Designation remains in effect.

Orphan Drug Designation. Veridian submitted a request for Orphan Drug Designation for VRD-4187 for the treatment of SCLC on November 8, 2021. The FDA granted Orphan Drug Designation for VRD-4187 for the treatment of SCLC on March 14, 2022. Orphan Drug Designation provides Veridian with certain regulatory and financial incentives, including eligibility for 7-year market exclusivity upon approval, tax credits for qualified clinical testing expenditures, and eligibility for FDA orphan drug grants. The implications of the Orphan Drug Designation for regulatory exclusivity are discussed in Section XIII.

Other Meeting Requests. Beyond the pre-IND and End-of-Phase I meetings, the data room contained records of one additional Type C meeting conducted with the FDA on August 9, 2022, which addressed CMC-related topics including the qualification of a new drug substance CDMO facility. The FDA provided generally supportive feedback and confirmed the adequacy of the proposed comparability study design for the manufacturing site change. No other Type A, B, or C meeting requests or minutes were identified in the data room.

Interactions with Specific FDA Divisions. All FDA interactions related to VRD-4187 have been conducted through the Office of Tissues and Advanced Therapies within CBER, which is the primary review division for the IND. No interactions with FDA's Office of Oncologic Diseases within CDER were identified, which is consistent with the regulatory pathway (CBER jurisdiction for biologic products).

VI. Clinical Trial Compliance

A. Good Clinical Practice (GCP) Compliance (21 CFR Parts 50, 56, 312)

We reviewed Veridian's framework for ensuring compliance with GCP requirements applicable to the conduct of clinical trials under 21 CFR Parts 50, 56, and 312, as well as the International Council for Harmonisation ("ICH") E6(R2) Guideline for Good Clinical Practice.

Standard Operating Procedures. Veridian has established a set of SOPs governing the conduct of clinical trials, including SOPs for: protocol development and amendment; informed consent; investigator selection and qualification; site monitoring; data management; adverse event reporting; essential document management; and clinical trial close-out. We reviewed the relevant SOPs identified in the data room and found them to be consistent with GCP requirements and industry standards for a company of Veridian's size and development stage.

Clinical Research Organizations. Veridian has engaged the following contract research organizations ("CROs") for the conduct of the Marlowe Asset Management-2 study:

(a) Glenrock Advisors — engaged as the primary CRO for clinical trial management, site monitoring, and data management for the Marlowe Asset Management-2 study, pursuant to a master services agreement dated February 2023.

(b) Greaves Consulting Group — engaged for central laboratory services, including sample analysis and biomarker assessments.

(c) Ashbury Group — engaged for independent central radiological review of tumor assessments (RECIST v1.1) for the primary ORR endpoint.

We reviewed the clinical trial agreements and master services agreements with each CRO and noted that the agreements contain appropriate provisions regarding GCP compliance, data ownership, confidentiality, and sponsor oversight. Transfer of obligations from Veridian to CROs under 21 CFR § 312.52 appeared to be appropriately documented.

Site Monitoring. Syneos Health conducts regular on-site and remote monitoring visits at each of the 42 Marlowe Asset Management-2 clinical trial sites in accordance with a monitoring plan approved by Veridian. We reviewed a sample of monitoring visit reports from the data room (covering approximately 15 of the 42 sites) and noted that monitoring visits have been conducted at the frequencies specified in the monitoring plan. The monitoring reports reviewed documented source data verification activities, informed consent verification, investigational product accountability, adverse event reporting compliance, and protocol deviation tracking. The monitoring reports identified a number of minor protocol deviations across sites (e.g., out-of-window assessments, delayed reporting of non-serious adverse events), all of which were classified as minor deviations, and none of which were classified as major or critical. Corrective actions were documented for each deviation identified.

Internal Audits. Veridian's quality assurance ("QA") group conducts periodic internal audits of clinical trial operations, including audits of CRO activities, clinical trial sites, and internal processes. We reviewed the audit reports from the two internal audits conducted during 2023: (i) an audit of Syneos Health's clinical data management practices for Marlowe Asset Management-2, conducted in June 2023; and (ii) an audit of four Marlowe Asset Management-2 clinical trial sites in the United States, conducted in October 2023. Both audits identified minor findings related to documentation practices and timeliness of query resolution, but no critical or major findings were identified. Corrective and preventive action ("CAPA") plans were implemented for all findings, and follow-up verification was completed.

FDA Clinical Investigator Inspections. We reviewed FDA inspection records for clinical investigators participating in VRD-4187 studies. The FDA conducted Bioresearch Monitoring ("BIMO") inspections at two Marlowe Asset Management-1 (Phase I) clinical trial sites during 2023:

(i) Site 101 (Massachusetts General Hospital, Dr. Kenneth Whitfield, PI): FDA inspection conducted in April 2023. The inspection resulted

MEMORANDUM
PRIVILEGED AND CONFIDENTIAL ATTORNEY-CLIENT PRIVILEGE ATTORNEY WORK PRODUCT
This memorandum has been prepared by Calderwood & Harkness LLP at the request of and for the sole use of its client, Penterra Pharmaceuticals Corp. This memorandum is protected by the attorney-client privilege and the work product doctrine. Any disclosure, copying, or distribution of this memorandum or its contents without the prior written consent of Calderwood & Harkness LLP is strictly prohibited.
TO: Oliver Mackenzie, Partner, Calderwood & Harkness LLP Harrison Wexford, Partner, Calderwood & Harkness LLP
CC: Thomas F. Holbrook, General Counsel, Penterra Pharmaceuticals Corp. Natalie Reiner, SVP Corporate Development, Penterra Pharmaceuticals Corp.
FROM: Megan Chu, Associate, Calderwood & Harkness LLP Derek Okonkwo, Associate, Calderwood & Harkness LLP
DATE: May 20, 2024
RE: Regulatory and FDA Compliance Due Diligence — Veridian Biosciences, Inc.
MATTER NO.: 1018-00008
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I. Executive Summary
This memorandum summarizes the results of our regulatory and FDA compliance due diligence review of Veridian Biosciences, Inc. ("Veridian" or the "Company") in connection with the proposed acquisition by Penterra Pharmaceuticals Corp. ("Penterra" or the "Buyer") of 100% of Veridian's outstanding capital stock (the "Transaction"). The proposed purchase price for the Transaction is $900,000,000 in cash, subject to customary adjustments as set forth in the draft stock purchase agreement currently under negotiation between the parties.
Scope of Review. Our review encompassed the following areas of Veridian's regulatory posture and FDA compliance: (a) all FDA regulatory filings, including Investigational New Drug ("IND") applications and amendments; (b) clinical trial documentation, including clinical protocols, investigator's brochures, data monitoring committee charters and minutes, and clinical trial agreements; (c) all FDA correspondence, including meeting request letters, meeting minutes, information requests, and agency responses; (d) pre-IND meeting materials and End-of-Phase I meeting materials; (e) adverse event reporting and pharmacovigilance documentation, including Individual Case Safety Reports and serious adverse event reports; (f) Good Manufacturing Practice ("GMP"), Good Laboratory Practice ("GLP"), and Good Clinical Practice ("GCP") compliance documentation; and (g) applicable requirements under Title 21 of the Code of Federal Regulations ("21 CFR"), including Parts 11, 50, 56, 58, 210, 211, and 312, as relevant to Veridian's current stage of development. Our review covered the entirety of Veridian's development pipeline, with particular emphasis on the Company's lead candidate, VRD-4187.
Coordination with Scientific Advisors. This memorandum was prepared in coordination with the clinical and scientific due diligence being conducted by Broadleaf Scientific Consulting LLC, under the direction of Dr. Raymond Kapoor, Managing Director. Dr. Kapoor's team is responsible for assessing the clinical and scientific merits of Veridian's pipeline candidates, including the quality and interpretability of clinical trial data. Clinical and scientific assessments are beyond the scope of this legal due diligence memorandum and are addressed separately in Broadleaf's report. Where relevant, we have noted areas of overlap between regulatory and scientific considerations.
Sources Reviewed. In preparing this memorandum, we reviewed the following categories of materials and information:
• Virtual data room materials hosted on the Thackeray Solutions platform, made available by Veridian's legal counsel, Zalcourt Archer & Cole LLP (Rebecca Whitmore, Partner), beginning March 11, 2024. The virtual data room contained approximately 4,200 documents organized across regulatory, clinical, CMC, nonclinical, corporate, intellectual property, and financial categories.
• Supplemental document requests submitted by Calderwood & Harkness LLP on March 28, 2024, April 12, 2024, and April 30, 2024, with responsive documents received and uploaded to the data room through May 15, 2024.
• Management interviews conducted during April 2024, including interviews with: (i) Dr. Julian Marek, Chief Executive Officer and co-founder; (ii) Dr. Priya Chandrasekaran, Chief Scientific Officer and co-founder; and (iii) Dr. Anne-Marie Fontaine, Vice President, Regulatory Affairs. These interviews were conducted via videoconference on April 8, 2024 (Dr. Marek), April 10, 2024 (Dr. Chandrasekaran), and April 15, 2024 (Dr. Fontaine), and addressed regulatory strategy, FDA interactions, clinical trial conduct, safety experience, and manufacturing arrangements.
• Publicly available FDA databases, including the FDA Establishment Registration and Device Listing database, the Debarment List, the FDA Warning Letters database, and the ClinicalTrials.gov registry.
High-Level Findings. Based on our review, we report the following high-level findings:
Veridian is a clinical-stage biotechnology company with no marketed products and no product revenue. For fiscal year ended December 31, 2023, the Company reported total revenue of $0 and a net loss of ($87.3 million). The Company's regulatory posture is centered on three immuno-oncology candidates developed on its proprietary VeriTCE (Veridian T-Cell Engager) bispecific antibody platform. The lead candidate, VRD-4187, a bispecific T-cell engager targeting DLL3-expressing tumors for the treatment of small cell lung cancer ("SCLC"), has an active IND (IND No. 154832) and is currently in a Phase II clinical trial (the Marlowe Asset Management-2 study, ClinicalTrials.gov Identifier NCT05837291). The second pipeline candidate, VRD-5923, is in early clinical development, and the third candidate, VRD-7011, remains in the preclinical stage.
Compliance with applicable FDA regulatory requirements appears to be generally satisfactory across all areas reviewed. We identified no material deficiencies in Veridian's IND filings, clinical trial conduct, safety reporting, or GCP compliance. The Company has received no FDA warning letters, consent decrees, injunctions, or debarment actions. No clinical holds or partial clinical holds have been imposed on any of Veridian's IND applications. The Company's regulatory affairs team is experienced and appropriately staffed for the Company's current stage of development.
Notwithstanding the generally favorable compliance posture, we have identified several key risk factors that warrant attention in the context of the Transaction, which are discussed in detail in Section XIV of this memorandum. These include: (a) the inherent clinical-stage development risk associated with VRD-4187, including the upcoming Phase II interim analysis expected in approximately August 2024; (b) the single-asset concentration of the pipeline, with the vast majority of Veridian's enterprise value attributable to VRD-4187; (c) the known cytokine release syndrome ("CRS") safety signal associated with the bispecific T-cell engager class, which will require ongoing monitoring; (d) the Company's dependency on third-party contract development and manufacturing organizations ("CDMOs") for all manufacturing activities; and (e) inherent uncertainty regarding FDA's future regulatory requirements and standards for approvability. Our specific recommendations regarding the treatment of these risk factors in the definitive transaction documentation are set forth in Section XV.
II. Company Regulatory Overview
A. Company Background
Veridian Biosciences, Inc. is a corporation organized and existing under the laws of the State of Delaware, with its principal office and corporate headquarters located at 550 Gateway Drive, Cambridge, Massachusetts 02142. The Company was founded in 2016 by Dr. Julian Marek and Dr. Priya Chandrasekaran, who currently serve as Chief Executive Officer and Chief Scientific Officer, respectively. Veridian was organized for the purpose of developing novel bispecific T-cell engager immunotherapies for the treatment of solid tumors, leveraging the proprietary VeriTCE antibody engineering platform developed by Drs. Marek and Chandrasekaran during their prior academic research at the Massachusetts Institute of Technology.
Veridian is a clinical-stage biotechnology company. As of the date of this memorandum, the Company has no marketed products and has never received approval from the FDA or any other regulatory authority for the marketing of any pharmaceutical or biological product. The Company does not hold any approved New Drug Applications ("NDAs") or Biologics License Applications ("BLAs"). Accordingly, the Company has generated no product revenue since its inception. For fiscal year 2023, the Company reported total revenue of $0 and a net loss of ($87.3 million), reflecting expenditures primarily attributable to research and development activities, including clinical trial costs, manufacturing costs for clinical supply, and general and administrative expenses. As of March 31, 2024, the Company reported cash and cash equivalents of approximately $112.4 million, which, based on its current operating burn rate, management estimates would fund operations into approximately the first quarter of 2025 absent additional financing or a change-of-control transaction.
The Company employs approximately 148 individuals as of the anticipated signing date of the stock purchase agreement, including scientific, regulatory, clinical operations, manufacturing and supply chain, finance, legal, and administrative personnel. The majority of the Company's employees are located at its Cambridge, Massachusetts headquarters, with a smaller number of employees supporting clinical trial operations remotely.
Since its founding, Veridian has raised approximately $420 million in aggregate through four rounds of venture capital and growth equity financing (Series A through Series D). The Company's principal institutional investors include Crestline Ventures, LP, which holds approximately 28.3% of the Company's outstanding capital stock on a fully diluted basis; Boreal Health Partners Fund III, LP, which holds approximately 19.7%; and Apex Growth Equity Fund II, LP, which holds approximately 14.1%. The remaining equity is held by the Company's founders, management team, employees (through stock option and restricted stock unit grants), and a number of smaller institutional and angel investors. The capitalization table and equity ownership structure are addressed in detail in the Corporate Due Diligence Memorandum dated May 16, 2024.
B. Regulatory Affairs Organization
Veridian's regulatory affairs function is led by Dr. Anne-Marie Fontaine, Vice President, Regulatory Affairs, who has been with the Company since 2018 and reports directly to Dr. Julian Marek, Chief Executive Officer. Dr. Fontaine holds a Pharm.D. degree from the University of Michigan and a Master of Science in Regulatory Science from the University of Southern California. Prior to joining Veridian, Dr. Fontaine spent approximately eleven years in regulatory affairs positions at Pemberton Partners LLC and Camberwell Corporation (now part of Halcyon Industries), where she was involved in multiple IND filings, BLA submissions, and FDA advisory committee proceedings in the oncology therapeutic area. We view Dr. Fontaine's experience and qualifications as a significant asset for the Company's regulatory strategy.
The regulatory affairs team reporting to Dr. Fontaine consists of approximately 12 professionals, organized into the following functional areas:
• IND Management (3 professionals): Responsible for the preparation, submission, and maintenance of IND applications, including IND amendments, annual reports, and safety reports; management of the regulatory dossier; and tracking of FDA correspondence.
• Clinical Operations Regulatory Support (3 professionals): Responsible for providing regulatory guidance to the clinical operations team, including protocol development support, informed consent form review, site regulatory document management, and ClinicalTrials.gov registration and reporting compliance.
• Chemistry, Manufacturing, and Controls (CMC) Regulatory (3 professionals): Responsible for the CMC sections of regulatory filings, including drug substance and drug product specifications, manufacturing process descriptions, stability data, and coordination with CDMOs on regulatory aspects of manufacturing.
• Pharmacovigilance and Drug Safety (3 professionals): Responsible for adverse event reporting, safety database management, signal detection, preparation of IND safety reports (15-day and 7-day expedited reports), and aggregate safety analyses.
In addition to the internal regulatory team, the Company has retained external regulatory consultants for specialized submission activities, including: (i) Ashford Advisors for CMC regulatory strategy consulting and FDA meeting preparation; and (ii) Fenmore Advisory Group for pharmacovigilance database implementation and validation. Engagement letters and scopes of work for these consultants were identified in the data room and reviewed.
Based on our review and our interview with Dr. Fontaine, we believe that the regulatory affairs organization is appropriately structured and staffed for the Company's current stage of development. However, we note that a significant expansion of the regulatory team will likely be necessary as VRD-4187 advances toward a potential BLA submission, and that such expansion planning should be incorporated into Penterra's post-acquisition integration planning.
C. FDA Registration and Establishment Status
Veridian is registered with the FDA as a sponsor of investigational drugs, as required for the submission and maintenance of IND applications under 21 CFR Part 312. The Company's FDA Data Universal Numbering System ("DUNS") number and Facility Establishment Identifier ("FEI") are on file.
Critically, the Company does not hold any FDA facility registrations for pharmaceutical or biological manufacturing. Veridian does not maintain any internal manufacturing capabilities for drug substance or drug product. All manufacturing of VRD-4187 clinical supply, including cell line development, cell culture and fermentation, purification, formulation, and fill/finish, is outsourced to contract development and manufacturing organizations, as discussed in detail in Section VII of this memorandum. As a result, the Company itself has not been subject to FDA establishment inspections or pre-approval inspections. The FDA inspection histories of the CDMO facilities utilized by Veridian are reviewed separately in Section VII.A.
We confirmed through review of the FDA Warning Letters database and the FDA Debarment List that no warning letters, debarment actions, or other enforcement actions have been issued to Veridian Biosciences, Inc. or to any of its officers, directors, or employees as of the date of this memorandum.
III. Pipeline Overview and Regulatory Status of Each Candidate
The following section provides an overview of each of the three product candidates in Veridian's development pipeline and the current regulatory status of each as of May 2024.
A. VRD-4187 (Lead Candidate)
Product Description. VRD-4187 is a bispecific T-cell engager antibody construct developed using Veridian's proprietary VeriTCE platform technology. VRD-4187 is designed to simultaneously bind to DLL3 (Delta-like ligand 3), a protein expressed on the surface of small cell lung cancer tumor cells, and CD3, a component of the T-cell receptor complex on cytotoxic T lymphocytes. By creating a bridge between DLL3-expressing tumor cells and T cells, VRD-4187 is intended to redirect the patient's own immune system to recognize and destroy tumor cells. DLL3 is an attractive target for SCLC because it is highly expressed on SCLC tumor cells but has limited expression on normal adult tissues, which is intended to minimize off-target toxicity.
SCLC is an aggressive form of lung cancer that accounts for approximately 10-15% of all lung cancers and is characterized by rapid growth, early metastasis, and poor prognosis. The five-year survival rate for extensive-stage SCLC is less than 5%. Treatment options for relapsed or refractory SCLC are limited, and there remains a significant unmet medical need for novel therapeutic approaches. VRD-4187 is being developed initially for the treatment of patients with extensive-stage SCLC who have progressed after first-line platinum-based chemotherapy.
IND Number. IND 154832.
IND Filing Date. The original IND application for VRD-4187 was submitted to the FDA on June 14, 2021. The FDA's 30-day safety review period expired on July 14, 2021, without the imposition of a clinical hold, and the IND became effective on that date. The Company initiated its first-in-human Phase I clinical trial (Study VRD-4187-001, also referred to as the "Marlowe Asset Management-1" study) in August 2021.
Current Regulatory Status as of May 2024. IND 154832 is in active status. The Phase I dose-escalation and dose-expansion study (Marlowe Asset Management-1) has been completed. The Company's lead registrational study, a randomized, open-label Phase II clinical trial designated as the "Marlowe Asset Management-2" study, was initiated in March 2023 and is currently enrolling and treating patients.
Clinical Trial — Marlowe Asset Management-2. The Marlowe Asset Management-2 study is a randomized, open-label, multicenter Phase II clinical trial evaluating the efficacy and safety of VRD-4187 compared to investigator's choice of chemotherapy (topotecan or irinotecan) in patients with extensive-stage SCLC who have progressed after first-line platinum-based chemotherapy. The study is registered on ClinicalTrials.gov under Identifier NCT05837291.
Key details of the Marlowe Asset Management-2 study are as follows:
• Study Design: Randomized (1:1), open-label, active-controlled, multicenter Phase II trial.
• Study Sites: 42 clinical trial sites across the United States (28 sites) and the European Union (14 sites, located in Germany, France, Spain, the Netherlands, and Italy).
• Enrollment: As of the most recent enrollment update available in the data room (dated April 30, 2024), 387 patients have been enrolled and randomized, including 194 patients in the VRD-4187 treatment arm and 193 patients in the investigator's choice control arm. Target enrollment for the study is 450 patients.
• Primary Endpoint: Overall response rate ("ORR"), as assessed by independent central review using RECIST v1.1 criteria.
• Key Secondary Endpoints: Progression-free survival ("PFS"), overall survival ("OS"), duration of response ("DOR"), and safety and tolerability.
• Data Monitoring Committee: An independent Data Monitoring Committee ("DMC") has been established and is responsible for ongoing safety monitoring throughout the trial. The DMC charter, membership, and meeting minutes are discussed in Section IV.E.
• Interim Analysis: The clinical protocol provides for a pre-planned interim analysis of efficacy and safety data to be conducted by the DMC when approximately 75% of the expected ORR events have been observed. Based on current enrollment and follow-up timelines, the interim analysis is anticipated to occur in approximately Q3 2024 (estimated August 2024). The implications of this interim analysis for the Transaction are discussed in Section XIV.B.
• Current Status: The trial is ongoing. No interim data readout has yet occurred as of the date of this memorandum. The Company expects to complete enrollment by approximately July 2024 and anticipates the interim analysis in approximately August 2024, with potential topline results from the primary endpoint analysis available in late 2024 or early 2025.
Dosing and Protocol. The current dosing regimen for VRD-4187 in the Marlowe Asset Management-2 study, as specified in the clinical protocol (Protocol Version 3.2, dated January 22, 2024), employs a step-up dosing approach. Patients receive a starting dose of 0.5 mg/kg on Day 1, followed by escalation to 1.0 mg/kg on Day 8, and then to the target dose of 1.5 mg/kg on Day 15 and every two weeks thereafter. This step-up dosing regimen was developed to mitigate the risk and severity of cytokine release syndrome, based on the safety experience from the Phase I Marlowe Asset Management-1 study. The protocol includes detailed dose modification and de-escalation rules for the management of CRS and other adverse events, as well as specific guidance on the administration of prophylactic medications (including dexamethasone premedication) and the availability of tocilizumab at clinical trial sites for the treatment of CRS. We reviewed the current protocol (Version 3.2) and all prior versions (Versions 1.0, 2.0, 2.1, and 3.0) in the data room.
Regulatory Milestones Achieved. The following key regulatory milestones have been achieved for VRD-4187:
1. Pre-IND Meeting (Type B): Conducted on March 3, 2021 (discussed in Section V.A).
2. IND Submission: June 14, 2021.
3. IND Effective (no clinical hold): July 14, 2021.
4. Phase I Initiation (Marlowe Asset Management-1): August 2021.
5. Phase I Completion: December 2022.
6. End-of-Phase I Meeting (Type B): Conducted on January 24, 2023 (discussed in Section V.B).
7. Phase II Initiation (Marlowe Asset Management-2): March 2023.
Clinical Hold Status. As of the date of this memorandum, there are no clinical holds or partial clinical holds on IND 154832. The IND has been in continuous active status since it became effective on July 14, 2021, and has not at any time been subject to a full or partial clinical hold.
B. VRD-5923 (Pipeline Candidate #2)
Product Description. VRD-5923 is a bispecific T-cell engager antibody construct also developed on the VeriTCE platform. VRD-5923 targets a different tumor-associated antigen, CLDN18.2 (Claudin 18.2), which is expressed in gastric and gastroesophageal junction cancers. VRD-5923 employs the same bispecific architecture as VRD-4187, engaging both the tumor target (CLDN18.2) and CD3 on T cells to mediate tumor cell killing.
IND Number and Status. IND 167514 was submitted to the FDA on February 9, 2024. The 30-day safety review period expired on March 11, 2024, and the IND became effective without the imposition of a clinical hold. As of the date of this memorandum, VRD-5923 is in the early stages of a Phase I dose-escalation study (Study VRD-5923-001) that was initiated at two clinical trial sites in the United States in April 2024. The Phase I study is designed to evaluate the safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity of VRD-5923 in patients with CLDN18.2-positive advanced gastric or gastroesophageal junction adenocarcinoma. Enrollment in the Phase I study is in its early stages, with fewer than 10 patients enrolled as of the date of this memorandum.
Regulatory Interactions. A pre-IND meeting (Type B) for VRD-5923 was conducted with the FDA on September 12, 2023. Meeting minutes were reviewed in the data room. The FDA provided generally supportive feedback on the proposed Phase I study design, nonclinical package, and CMC strategy. The FDA recommended that Veridian consider incorporating correlative biomarker assessments to characterize the immune response and tumor microenvironment, which Veridian has incorporated into the Phase I protocol. No material disagreements with FDA were identified in the meeting minutes.
VRD-5923 is in a very early stage of clinical development and contributes a relatively modest portion of the overall regulatory profile under review. Detailed clinical and efficacy assessments for VRD-5923 are being addressed by Broadleaf Scientific Consulting LLC in their separate report.
C. VRD-7011 (Pipeline Candidate #3)
Product Description. VRD-7011 is a third bispecific T-cell engager construct on the VeriTCE platform, targeting MSLN (Mesothelin), a tumor-associated antigen expressed in mesothelioma, ovarian cancer, and pancreatic cancer. VRD-7011 is being developed as a potential treatment for malignant pleural mesothelioma.
Regulatory Status. VRD-7011 is in the preclinical stage of development. No IND application has been filed for VRD-7011 as of the date of this memorandum. The Company has completed certain in vitro and in vivo pharmacology studies and has initiated IND-enabling Good Laboratory Practice toxicology studies. Based on our interview with Dr. Fontaine, the Company anticipates submitting a pre-IND meeting request to the FDA for VRD-7011 in approximately Q4 2024, with a potential IND submission in the first half of 2025, subject to the completion of GLP toxicology studies and manufacturing process development.
Regulatory Interactions. No formal regulatory interactions with the FDA have occurred for VRD-7011 as of the date of this memorandum. The Company has not submitted a pre-IND meeting request, and no FDA feedback has been obtained. However, the data room contained internal regulatory strategy documents prepared by Dr. Fontaine's team outlining the proposed nonclinical development plan and anticipated IND filing strategy for VRD-7011, which we reviewed.
VRD-7011 is at a very early stage and does not materially contribute to the current regulatory due diligence assessment. However, we note that Veridian's intellectual property rights in the VeriTCE platform technology, which underpins all three pipeline candidates, are a critical asset of the Company and are addressed in the IP Due Diligence Memorandum dated May 14, 2024.
IV. Detailed IND Review — VRD-4187 (IND 154832)
A. IND Submission and Acceptance
The original IND application for VRD-4187 (IND 154832) was submitted to the FDA's Center for Biologics Evaluation and Research ("CBER") on June 14, 2021. The IND was submitted to CBER, rather than the Center for Drug Evaluation and Research ("CDER"), because VRD-4187 is a bispecific antibody construct that is expected to be regulated as a biological product under the Public Health Service Act ("PHSA") and, upon approval, would be the subject of a Biologics License Application ("BLA") rather than a New Drug Application ("NDA"). The IND was assigned to the Office of Tissues and Advanced Therapies within CBER, under review division oversight.
The FDA's 30-day safety review period, as prescribed by 21 CFR § 312.40(b)(1), commenced upon receipt of the IND submission and expired on July 14, 2021. The FDA did not impose a clinical hold during the 30-day review period, and the IND accordingly became effective by operation of the regulation on July 14, 2021, permitting the Company to initiate its Phase I clinical trial.
We reviewed the original IND submission package as contained in the data room. The IND included the following principal components, consistent with the requirements of 21 CFR § 312.23:
• Form FDA 1571 (Investigational New Drug Application cover form), properly executed by Dr. Julian Marek as the sponsor's authorized representative.
• Table of Contents and general investigational plan, describing the proposed Phase I dose-escalation study and the overall clinical development strategy for VRD-4187 in SCLC.
• Investigator's Brochure (Version 1.0, dated May 2021), containing a comprehensive summary of the physical, chemical, pharmaceutical, pharmacological, toxicological, pharmacokinetic, and clinical information known about VRD-4187 at the time of filing.
• Clinical Protocol (VRD-4187-001, Version 1.0, dated May 2021) for the Phase I Marlowe Asset Management-1 dose-escalation and dose-expansion study.
• CMC Section, including information on the drug substance (description of the bispecific antibody construct, manufacturing process, characterization, specifications, and reference standards) and drug product (formulation, manufacturing process, container closure system, specifications, and stability data).
• Pharmacology and Toxicology Section, including the results of nonclinical pharmacology studies (in vitro binding and cytotoxicity assays, in vivo efficacy studies in xenograft models), pharmacokinetic studies, and GLP-compliant toxicology studies (repeat-dose toxicity study in cynomolgus monkeys, tissue cross-reactivity study).
• Previous Human Experience Section: Not applicable (first-in-human study).
The IND submission appeared to be complete, well-organized, and consistent with the requirements of 21 CFR § 312.23 and applicable FDA guidance documents. The absence of a clinical hold during the 30-day review period indicates that the FDA did not identify safety concerns that would have prevented the initiation of clinical trials.
B. IND Amendments and Supplements
We reviewed all IND amendments and supplements filed for IND 154832 from the original submission date through May 15, 2024. The following is a chronological summary of the principal amendment categories:
Protocol Amendments. A total of seven protocol amendments have been filed for IND 154832 since the original IND submission, covering both the Phase I Marlowe Asset Management-1 study and the Phase II Marlowe Asset Management-2 study:
1. Protocol Amendment 1 (August 2021): VRD-4187-001, Version 1.1 — Minor administrative corrections to the Phase I protocol; no substantive changes to study design or dosing.
2. Protocol Amendment 2 (January 2022): VRD-4187-001, Version 2.0 — Modification of the Phase I dose-escalation scheme to incorporate a step-up dosing approach for the higher dose cohorts (≥1.0 mg/kg) based on emerging CRS data from the initial dose cohorts. This amendment was filed as a result of early safety observations indicating that more rapid dose escalation was associated with higher rates of Grade ≥2 CRS. The step-up dosing approach subsequently became the basis for the Phase II dosing regimen.
3. Protocol Amendment 3 (June 2022): VRD-4187-001, Version 2.1 — Addition of a dose-expansion cohort at the 1.5 mg/kg target dose level to further characterize the safety and preliminary efficacy of VRD-4187 at the recommended Phase II dose.
4. Protocol Amendment 4 (February 2023): Submission of the Phase II clinical protocol (VRD-4187-002, Marlowe Asset Management-2, Version 1.0), providing for the randomized, open-label Phase II study design.
5. Protocol Amendment 5 (July 2023): VRD-4187-002, Version 2.0 — Addition of three additional clinical trial sites in the European Union; modification of the exclusion criteria to permit enrollment of patients with treated, stable brain metastases; clarification of CRS grading and management algorithms.
6. Protocol Amendment 6 (November 2023): VRD-4187-002, Version 3.0 — Revision of the statistical analysis plan to reflect updated assumptions regarding ORR based on emerging Phase I efficacy data; update to the DMC charter to clarify the interim analysis trigger and futility boundary.
7. Protocol Amendment 7 (January 2024): VRD-4187-002, Version 3.2 — Minor modifications to the informed consent form to reflect updated safety information from the investigator's brochure; addition of a patient-reported outcome questionnaire.
We note that the modification to the dose-escalation scheme in Protocol Amendment 2 was a significant and proactive safety measure taken by Veridian in response to real-time clinical data. This demonstrates appropriate sponsor vigilance in monitoring safety data and modifying the clinical protocol to protect patient safety. The FDA did not impose a clinical hold in connection with the CRS observations that prompted this protocol amendment, and the step-up dosing approach has been accepted by the FDA as the basis for the Phase II dosing regimen.
Information Amendments. The Company filed approximately 14 information amendments under 21 CFR § 312.31 during the review period, including updates to the investigator's brochure (Versions 2.0, 3.0, 3.1, and 4.0), updated lists of clinical investigators, and notification of new clinical trial sites. All information amendments reviewed appeared to be filed in a timely manner and in compliance with regulatory requirements.
IND Safety Reports. IND safety reports are discussed in detail in Section IV.D below.
CMC Supplements. The Company filed approximately eight CMC-related amendments, including: (i) notification of a change from the original drug substance CDMO (discussed in Section VII); (ii) updated drug substance manufacturing process descriptions reflecting process optimization; (iii) revised drug product specifications; (iv) updated stability data supporting extended shelf life; and (v) qualification of a new drug product fill/finish facility. We reviewed each CMC supplement for completeness and noted no material issues.
Annual Reports. The Company filed IND annual reports for IND 154832 under 21 CFR § 312.33 for the following reporting periods: (i) Year 1 (July 14, 2021 – July 13, 2022), filed on September 28, 2022; (ii) Year 2 (July 14, 2022 – July 13, 2023), filed on September 15, 2023; and (iii) Year 3 (July 14, 2023 – July 13, 2024), expected to be filed in approximately September 2024 (not yet due as of the date of this memorandum). We reviewed the two filed annual reports for completeness and timeliness. Both annual reports were filed within the 60-day window following the anniversary of the IND effective date, as required by 21 CFR § 312.33(a). The reports contained required information regarding the status of each clinical study, updated safety information, summary of IND amendments filed, an update on the general investigational plan, and a log of outstanding business with FDA. We noted no material deficiencies in the annual reports.
C. FDA Correspondence
We reviewed all FDA correspondence contained in the data room related to IND 154832, including outgoing correspondence from Veridian to the FDA and incoming correspondence from the FDA to Veridian. In total, we reviewed approximately 68 items of FDA correspondence spanning the period from March 2021 (initial pre-IND meeting request) through May 2024.
The correspondence reviewed included the following categories:
• Meeting Requests and Meeting Minutes: Discussed in Section V.
• FDA Acknowledgment Letters: Standard FDA acknowledgment letters confirming receipt of IND amendments, safety reports, and annual reports.
• FDA Information Requests: The FDA issued three information requests to Veridian during the review period: (i) a December 2021 request for additional characterization data regarding VRD-4187 drug substance impurity profiles, which was addressed by Veridian in a CMC amendment filed in February 2022; (ii) a June 2022 request for clarification regarding the Phase I dose-escalation stopping rules following the implementation of step-up dosing, which was addressed by Veridian in a protocol amendment filed in July 2022; and (iii) a March 2024 request for updated stability data for drug product stored under the revised storage conditions, which was addressed by Veridian in a CMC amendment filed in April 2024. All three information requests were responded to within the timeframes requested by the FDA, and the FDA did not issue follow-up requests or express dissatisfaction with the responses.
• Veridian Responses to FDA: Responses to the information requests described above, as well as responses to various administrative communications.
No refusal-to-file letters, clinical hold letters, untitled letters, warning letters, or other enforcement-related communications from the FDA were identified in the data room. The FDA correspondence reviewed was consistent with routine regulatory interactions for a clinical-stage IND.
We note that Veridian's regulatory strategy documents reference the following FDA guidance documents as informing the Company's development approach for VRD-4187:
• FDA Guidance for Industry: Bispecific Antibody Development Programs (Draft Guidance, May 2021).
• FDA Guidance for Industry: Expedited Programs for Serious Conditions — Drugs and Biologics (May 2014).
• FDA Guidance for Industry: Clinical Trial Endpoints for the Approval of Cancer Drugs and Biologics (December 2018).
• FDA Guidance for Industry: Cytokine Release Syndrome in Patients Treated with Bispecific T-Cell Engaging Therapies — Grading and Management (Draft Guidance, March 2023).
D. Safety Reporting and Pharmacovigilance
We conducted a detailed review of Veridian's safety reporting procedures, adverse event documentation, and pharmacovigilance systems in connection with VRD-4187 clinical trials.
Safety Reporting Procedures. Veridian has established standard operating procedures ("SOPs") for the reporting of safety information to the FDA in compliance with 21 CFR § 312.32. The Company's pharmacovigilance SOPs address: (a) the collection, processing, and evaluation of adverse event reports from clinical trial investigators; (b) the determination of expectedness and seriousness of adverse events by reference to the investigator's brochure; (c) the preparation and submission of IND safety reports to the FDA, including 15-calendar-day reports for serious and unexpected suspected adverse reactions and 7-calendar-day reports for unexpected fatal or life-threatening suspected adverse reactions; (d) notification of clinical investigators of safety information; and (e) aggregate safety data analysis and signal detection. We reviewed the relevant SOPs and found them to be consistent with regulatory requirements and industry best practices.
Individual Case Safety Reports (ICSRs) / MedWatch Submissions. We reviewed the Company's safety database, which is maintained using the Ridgeline Industries Argus Safety system (validated in accordance with 21 CFR Part 11 requirements, as discussed in Section IX.B). The database contains all adverse event reports from the Phase I Marlowe Asset Management-1 study and the ongoing Phase II Marlowe Asset Management-2 study. Veridian's pharmacovigilance team processes incoming adverse event reports from clinical trial investigators, evaluates them for seriousness, expectedness, and causality, and prepares IND safety reports for submission to the FDA as applicable.
Serious Adverse Event (SAE) Reporting. We reviewed a sample of IND safety reports submitted by Veridian to the FDA for VRD-4187. During the Phase I Marlowe Asset Management-1 study (which enrolled a total of 78 patients), the Company filed 23 IND safety reports, of which 19 were 15-calendar-day expedited reports for serious and unexpected suspected adverse reactions and 4 were 7-calendar-day reports for unexpected fatal or life-threatening suspected adverse reactions. We reviewed a representative sample of these reports for compliance with the timing and content requirements of 21 CFR § 312.32 and noted no instances of late reporting. All reports appeared to contain the required minimum information (identifiable patient, identifiable reporter, suspected drug, and adverse event) and were submitted within the applicable reporting timeframes.
For the Phase II Marlowe Asset Management-2 study (387 patients enrolled as of April 30, 2024), the Company has filed 41 IND safety reports through May 15, 2024, of which 36 were 15-calendar-day reports and 5 were 7-calendar-day reports. We reviewed a representative sample and again noted compliance with timing and content requirements.
Adverse Events of Special Interest. The investigator's brochure for VRD-4187 (Version 4.0, dated December 2023) identifies the following adverse events of special interest for the compound:
(a) Cytokine Release Syndrome (CRS)
(b) Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS)
(c) Hepatotoxicity (elevated transaminases)
(d) Tumor lysis syndrome
(e) Infection and neutropenia
Of these, CRS is the most clinically significant and is recognized as a known class effect of bispecific T-cell engager therapies. CRS results from the massive release of cytokines by activated T cells upon engagement of the bispecific antibody with target cells and is characterized by fever, hypotension, hypoxia, and, in severe cases, multi-organ dysfunction. CRS has been a significant clinical challenge in the development of other bispecific T-cell engagers, including blinatumomab (Blincyto) and teclistamab (Tecvayli).
CRS Safety Data Review. Based on our review of the aggregate safety data available in the data room from the Phase I Marlowe Asset Management-1 study, CRS was reported in approximately 62% of patients (48 of 78), with the following grading distribution (using the Lee criteria, as specified in the protocol):
The overall CRS rate of 62% and the Grade ≥3 rate of approximately 9% are within the ranges that have been reported for other approved bispecific T-cell engager therapies targeting CD3. Importantly, the implementation of the step-up dosing approach in Protocol Amendment 2 substantially reduced the incidence and severity of CRS in later dose cohorts compared to earlier cohorts that used a more rapid escalation schedule. The Company reported that no treatment-related deaths attributable to CRS occurred in the Phase I study, and all CRS events resolved with appropriate management (including tocilizumab administration in Grade ≥2 cases and corticosteroid administration in refractory cases).
We note, however, that the Phase II Marlowe Asset Management-2 study is enrolling a larger and more diverse patient population than the Phase I study, including patients at 42 sites with varying levels of experience in managing CRS. The Phase II safety data set is not yet mature and has not been subject to an interim analysis. Accordingly, the CRS safety profile in the Phase II population remains an area of ongoing monitoring and a key risk factor, as discussed in Section XIV.C.
Mitigation Strategies. The clinical protocol for Marlowe Asset Management-2 incorporates the following CRS mitigation strategies, which were reviewed and noted:
(i) Step-up dosing regimen (0.5 mg/kg → 1.0 mg/kg → 1.5 mg/kg) over the first three treatment cycles.
(ii) Mandatory dexamethasone premedication prior to each dose during the step-up period.
(iii) Mandatory availability of tocilizumab at each clinical trial site prior to the administration of VRD-4187.
(iv) Required 24-hour inpatient observation following administration of the first and second doses.
(v) Detailed CRS grading, management, and dose modification algorithms in the protocol, including dose de-escalation and treatment discontinuation criteria.
(vi) Required investigator training on CRS recognition and management prior to site activation.
E. Data Monitoring Committee
We reviewed the DMC charter (Version 2.0, dated October 2023) and the minutes of all DMC meetings held through the date of this memorandum. The DMC for the Marlowe Asset Management-2 study is composed of five independent members, including three medical oncologists with expertise in thoracic malignancies, one biostatistician, and one clinical pharmacologist. None of the DMC members have financial relationships with Veridian or conflicts of interest that would compromise their independence.
The DMC charter provides that the DMC is responsible for: (a) ongoing safety monitoring of the Marlowe Asset Management-2 trial; (b) review of unblinded safety and efficacy data at scheduled interim analyses; (c) authority to recommend modifications to the trial protocol, temporary suspension of enrollment, or termination of the trial based on safety or efficacy considerations; and (d) communication of recommendations to the sponsor. The DMC operates under a pre-specified statistical analysis plan that defines the interim analysis trigger, the efficacy futility boundary, and the safety stopping rules.
Since the initiation of the Marlowe Asset Management-2 study, the DMC has convened four scheduled meetings (in June 2023, October 2023, February 2024, and May 2024) and no unscheduled emergency meetings. We reviewed the minutes of all four meetings. At each meeting, the DMC reviewed aggregate safety data, including CRS rates, SAE rates, and treatment-related adverse event summaries. At all four meetings, the DMC recommended continuation of the trial without modification. No safety alerts, enrollment suspensions, protocol modifications, or trial termination recommendations have been issued by the DMC as of the date of this memorandum.
Upcoming Interim Analysis. The protocol-specified interim analysis is the next critical milestone for the Marlowe Asset Management-2 study. The interim analysis is triggered when approximately 75% of the expected events for the primary ORR endpoint have been observed. Based on current enrollment and follow-up timelines, the Company and the DMC anticipate that the interim analysis trigger will be reached in approximately August 2024. At the interim analysis, the DMC will review unblinded efficacy and safety data and will have the authority to: (i) recommend continuation of the trial without modification; (ii) recommend modification of the trial design or dosing; (iii) recommend suspension of enrollment; or (iv) recommend termination of the trial for futility or safety reasons.
Risk Flag. The DMC interim analysis scheduled for approximately August 2024 represents a critical inflection point for VRD-4187 and for Veridian's enterprise value. Adverse results from the interim analysis — including evidence of insufficient efficacy (failure to meet the futility boundary), an unacceptable safety profile (elevated rates of Grade ≥3 CRS, treatment-related mortality, or other serious adverse events), or a DMC recommendation to modify, suspend, or terminate the trial — could materially and adversely affect the regulatory and commercial outlook for VRD-4187. Given the single-asset concentration of Veridian's pipeline (discussed in Section XIV.D), such adverse results could fundamentally alter the value proposition underlying the Transaction.
We strongly recommend that the definitive stock purchase agreement address the implications of the interim analysis and adverse interim data as follows: (a) the material adverse effect definition should specifically contemplate adverse clinical trial results and DMC recommendations; (b) the closing conditions should include a bring-down of the Seller's representations regarding the regulatory status of VRD-4187 (including the absence of clinical holds and the continuation of the trial in accordance with the protocol); and (c) the operating covenants should require prompt notification to Penterra of any DMC recommendations or FDA communications that could affect the trial. These recommendations are discussed further in Section XV.
V. Pre-IND Meeting and FDA Interactions
A. Pre-IND Meeting — VRD-4187
Veridian conducted a pre-IND meeting (Type B meeting) with the FDA regarding VRD-4187 on March 3, 2021. The meeting request was submitted on December 15, 2020, in accordance with FDA's meeting management procedures, and the briefing document was submitted on February 3, 2021. The meeting was conducted via teleconference with representatives from FDA's Office of Tissues and Advanced Therapies within CBER.
We reviewed the meeting request letter, the briefing document, and the official FDA meeting minutes (dated March 22, 2021) in the data room. The key topics discussed and FDA's feedback included:
Proposed Clinical Development Plan. Veridian presented a proposed Phase I/II clinical development strategy for VRD-4187 in relapsed/refractory extensive-stage SCLC. The FDA generally agreed with the proposed Phase I dose-escalation study design and recommended that Veridian consider incorporating pharmacokinetic and pharmacodynamic biomarker assessments into the Phase I study to inform dose selection for the Phase II study.
Nonclinical Package. The FDA reviewed the proposed nonclinical data package and confirmed that the completed and planned nonclinical studies (including the GLP-compliant repeat-dose toxicity study in cynomolgus monkeys) would be adequate to support the IND submission, provided that the final study reports were available at the time of IND filing. The FDA noted that because VRD-4187 is a species-specific bispecific antibody (binding to human DLL3 and human CD3), the cynomolgus monkey was an appropriate and relevant animal species for toxicology assessment.
CMC Strategy. The FDA provided feedback on the proposed CMC strategy for the IND, including recommendations regarding drug substance characterization, impurity specifications, and the need for comparability assessments in the event of manufacturing process changes.
CRS Risk Management. The FDA specifically raised the topic of CRS risk management, referencing the known CRS safety profile of the blinatumomab (bispecific T-cell engager) class. The FDA recommended that Veridian incorporate detailed CRS grading, management, and dose modification algorithms into the Phase I clinical protocol, and that Veridian consider a step-up dosing approach to mitigate CRS risk. Veridian's subsequent adoption of the step-up dosing approach in Protocol Amendment 2 was consistent with this FDA recommendation.
Areas of Alignment and Divergence. Based on our review of the meeting minutes and subsequent regulatory filings, Veridian's clinical development program for VRD-4187 has been generally aligned with the FDA's pre-IND meeting feedback. We identified one area where Veridian's approach diverged from an FDA suggestion: the FDA suggested that Veridian consider a randomized, placebo-controlled Phase II design, whereas Veridian elected to proceed with a randomized, open-label, active-controlled design (with investigator's choice of chemotherapy as the comparator arm). Veridian discussed this design decision with the FDA at the End-of-Phase I meeting (discussed below), and the FDA did not object to the active-controlled design.
B. End-of-Phase I Meeting
Veridian conducted an End-of-Phase I meeting (Type B meeting) with the FDA on January 24, 2023, following the completion of the Phase I Marlowe Asset Management-1 study. The meeting request was submitted on October 18, 2022, and the briefing document was submitted on January 4, 2023. The meeting was conducted via teleconference.
We reviewed the meeting request letter, the briefing document, and the official FDA meeting minutes (dated February 14, 2023). The key topics discussed included:
Phase II Study Design. Veridian presented the proposed Phase II Marlowe Asset Management-2 study design, including the randomized, open-label, active-controlled design with ORR as the primary endpoint. The FDA agreed that ORR, as assessed by independent central review using RECIST v1.1, was an acceptable primary endpoint for a Phase II study in relapsed/refractory SCLC, noting that ORR has been accepted as a basis for accelerated approval in this indication. The FDA recommended that Veridian also collect overall survival data as a secondary endpoint to support a potential confirmatory benefit. Veridian incorporated OS as a key secondary endpoint in the Marlowe Asset Management-2 protocol.
Dose Selection. The FDA agreed with Veridian's selection of the 1.5 mg/kg target dose (with step-up dosing) as the recommended Phase II dose, based on the totality of the Phase I safety and efficacy data.
Patient Population. The FDA agreed with the proposed patient population (extensive-stage SCLC, second-line or later). The FDA recommended that Veridian consider enrolling patients with treated, stable brain metastases, noting the high incidence of brain metastases in SCLC and the importance of generating data in this patient population. Veridian subsequently amended the protocol (Protocol Amendment 5, Version 2.0) to permit enrollment of patients with treated, stable brain metastases.
Special Protocol Assessment (SPA). We specifically reviewed whether Veridian requested or obtained a Special Protocol Assessment from the FDA for the Marlowe Asset Management-2 study. Based on our review of the data room documents and our interview with Dr. Fontaine, Veridian did not submit an SPA request for Marlowe Asset Management-2. Dr. Fontaine stated that the Company determined that an SPA was not necessary or advisable at the Phase II stage because: (i) the Marlowe Asset Management-2 study is designed as a Phase II study supporting a potential accelerated approval based on ORR, not as a Phase III confirmatory study; and (ii) the Company intends to discuss the design of a confirmatory Phase III study with the FDA following the Phase II data readout, at which point an SPA may be pursued. We note that the absence of an SPA means that the FDA has not formally agreed to the adequacy of the Marlowe Asset Management-2 study design for a specific regulatory purpose, and the FDA retains discretion to require additional clinical data or a different study design to support a BLA submission. This is a relevant consideration for Penterra's assessment of regulatory risk.
C. Other FDA Interactions
Breakthrough Therapy Designation (BTD). We reviewed whether Veridian applied for or received Breakthrough Therapy Designation for VRD-4187. Based on our review of the data room and our interview with Dr. Fontaine, Veridian submitted a request for Breakthrough Therapy Designation for VRD-4187 for the treatment of extensive-stage SCLC to the FDA on April 15, 2023, following the completion of the Phase I study. The FDA denied the BTD request on July 3, 2023, stating that while the preliminary clinical data were encouraging, the data were insufficient to demonstrate a substantial improvement over existing therapies at that early stage of development. Veridian intends to re-submit the BTD request following the availability of Phase II data. The denial of the initial BTD request is not unusual for early-stage programs and does not, in our assessment, reflect a negative regulatory signal; however, it does mean that VRD-4187 does not currently benefit from the enhanced FDA engagement and rolling review features associated with BTD.
Fast Track Designation. Veridian was granted Fast Track Designation for VRD-4187 for the treatment of extensive-stage SCLC by the FDA on September 22, 2021. Fast Track Designation provides Veridian with the opportunity for more frequent interactions with the FDA and eligibility for rolling review of a future BLA submission. The Fast Track Designation remains in effect.
Orphan Drug Designation. Veridian submitted a request for Orphan Drug Designation for VRD-4187 for the treatment of SCLC on November 8, 2021. The FDA granted Orphan Drug Designation for VRD-4187 for the treatment of SCLC on March 14, 2022. Orphan Drug Designation provides Veridian with certain regulatory and financial incentives, including eligibility for 7-year market exclusivity upon approval, tax credits for qualified clinical testing expenditures, and eligibility for FDA orphan drug grants. The implications of the Orphan Drug Designation for regulatory exclusivity are discussed in Section XIII.
Other Meeting Requests. Beyond the pre-IND and End-of-Phase I meetings, the data room contained records of one additional Type C meeting conducted with the FDA on August 9, 2022, which addressed CMC-related topics including the qualification of a new drug substance CDMO facility. The FDA provided generally supportive feedback and confirmed the adequacy of the proposed comparability study design for the manufacturing site change. No other Type A, B, or C meeting requests or minutes were identified in the data room.
Interactions with Specific FDA Divisions. All FDA interactions related to VRD-4187 have been conducted through the Office of Tissues and Advanced Therapies within CBER, which is the primary review division for the IND. No interactions with FDA's Office of Oncologic Diseases within CDER were identified, which is consistent with the regulatory pathway (CBER jurisdiction for biologic products).
VI. Clinical Trial Compliance
A. Good Clinical Practice (GCP) Compliance (21 CFR Parts 50, 56, 312)
We reviewed Veridian's framework for ensuring compliance with GCP requirements applicable to the conduct of clinical trials under 21 CFR Parts 50, 56, and 312, as well as the International Council for Harmonisation ("ICH") E6(R2) Guideline for Good Clinical Practice.
Standard Operating Procedures. Veridian has established a set of SOPs governing the conduct of clinical trials, including SOPs for: protocol development and amendment; informed consent; investigator selection and qualification; site monitoring; data management; adverse event reporting; essential document management; and clinical trial close-out. We reviewed the relevant SOPs identified in the data room and found them to be consistent with GCP requirements and industry standards for a company of Veridian's size and development stage.
Clinical Research Organizations. Veridian has engaged the following contract research organizations ("CROs") for the conduct of the Marlowe Asset Management-2 study:
(a) Glenrock Advisors — engaged as the primary CRO for clinical trial management, site monitoring, and data management for the Marlowe Asset Management-2 study, pursuant to a master services agreement dated February 2023.
(b) Greaves Consulting Group — engaged for central laboratory services, including sample analysis and biomarker assessments.
(c) Ashbury Group — engaged for independent central radiological review of tumor assessments (RECIST v1.1) for the primary ORR endpoint.
We reviewed the clinical trial agreements and master services agreements with each CRO and noted that the agreements contain appropriate provisions regarding GCP compliance, data ownership, confidentiality, and sponsor oversight. Transfer of obligations from Veridian to CROs under 21 CFR § 312.52 appeared to be appropriately documented.
Site Monitoring. Syneos Health conducts regular on-site and remote monitoring visits at each of the 42 Marlowe Asset Management-2 clinical trial sites in accordance with a monitoring plan approved by Veridian. We reviewed a sample of monitoring visit reports from the data room (covering approximately 15 of the 42 sites) and noted that monitoring visits have been conducted at the frequencies specified in the monitoring plan. The monitoring reports reviewed documented source data verification activities, informed consent verification, investigational product accountability, adverse event reporting compliance, and protocol deviation tracking. The monitoring reports identified a number of minor protocol deviations across sites (e.g., out-of-window assessments, delayed reporting of non-serious adverse events), all of which were classified as minor deviations, and none of which were classified as major or critical. Corrective actions were documented for each deviation identified.
Internal Audits. Veridian's quality assurance ("QA") group conducts periodic internal audits of clinical trial operations, including audits of CRO activities, clinical trial sites, and internal processes. We reviewed the audit reports from the two internal audits conducted during 2023: (i) an audit of Syneos Health's clinical data management practices for Marlowe Asset Management-2, conducted in June 2023; and (ii) an audit of four Marlowe Asset Management-2 clinical trial sites in the United States, conducted in October 2023. Both audits identified minor findings related to documentation practices and timeliness of query resolution, but no critical or major findings were identified. Corrective and preventive action ("CAPA") plans were implemented for all findings, and follow-up verification was completed.
FDA Clinical Investigator Inspections. We reviewed FDA inspection records for clinical investigators participating in VRD-4187 studies. The FDA conducted Bioresearch Monitoring ("BIMO") inspections at two Marlowe Asset Management-1 (Phase I) clinical trial sites during 2023:
(i) Site 101 (Massachusetts General Hospital, Dr. Kenneth Whitfield, PI): FDA inspection conducted in April 2023. The inspection resulted

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