Tom Shrader

Tom Schrader inquired about the efficacy of D-cycloserine (DCS) with TMS compared to ketamine, the uniqueness of DCS in this combination, the practical application of NRx 101 in the procedure, and the logistical steps for clinics to utilize the drug, including reimbursement and availability.

Answer

Matthew Duffy, Chief Business Officer, explained that DCS, unlike ketamine, acts as an NMDA agonist at low doses, affecting the glycine site and enhancing neuroplasticity, with evidence suggesting ketamine may decrease TMS effectiveness. He noted that NRx 101 contains the effective low-dose DCS (150-175mg) and is available via an expanded access protocol for physicians who provide data.

Tom Schrader inquired about the efficacy of D-cycloserine (DCS) combined with TMS compared to ketamine, the uniqueness of DCS in this application, and the logistical and reimbursement aspects of integrating NRx 101 (containing DCS) into TMS procedures.

Answer

Matthew Duffy, Chief Business Officer, explained that DCS, unlike ketamine, acts as an NMDA agonist at low doses and is highly neuroplastic, with evidence suggesting ketamine may decrease TMS effectiveness. He noted that NRx 101's 150-175mg DCS dose is suitable and that an expanded access protocol is available for physicians to use DCS with TMS, with data to be reported on clinicaltrials.gov.

Tom Schrader of BTIG questioned the rationale for seeking an accelerated approval pathway for NRX-101, given its conventional clinical endpoints, and asked whether the new Commissioner's National Priority Voucher (CNPV) could be sold like previous voucher types.

Answer

Jonathan Javitt, Founder, Chairman and CEO, clarified that the CNPV is not sellable and NRXP's sole objective is rapid drug delivery to patients. He explained that NRX-101's trial demonstrated reductions in akathisia and suicidality, considered intermediate endpoints, which makes the accelerated approval pathway appropriate, with a commitment for a future confirmatory trial using depression as the primary endpoint.

Inquired about the nature of clinic acquisitions in Florida and the regulatory process of filing both an ANDA and an NDA for ketamine at the same time.

Answer

Clinic acquisitions are expected to be 'chunky,' meaning they will generally involve more than one clinic at a time. Regarding the dual filings, the NDA is for the psychiatry division to add new indications (depression, suicidality), while the ANDA is to offer a preservative-free version of the already generic drug for its existing indications. The same manufacturing data package can be used for both applications.

An analyst on behalf of Tom Schrader asked about the range of MMSE scores being tracked in the ALPITUDE trial and the frequency of cognitive testing.

Answer

Chief Medical Officer Dr. Eric Siemers clarified that while MMSE is a secondary outcome, the primary outcome is the iADRS scale. He stated that main cognitive assessments are conducted every three months. He also noted that the late 2026 top-line data release will include primary efficacy and safety, with more detailed biomarker results potentially rolling out in the subsequent weeks as assays are completed.

Tom Shrader of BTIG asked if the 2027 profitability target assumes flat worldwide COVID-19 vaccine usage. He also questioned the scientific feasibility of developing a multi-year influenza vaccine given constant strain drift.

Answer

EVP, CFO & Treasurer Jim Kelly clarified that the path to profitability by 2027 is not dependent on a single assumption but can be achieved through multiple avenues, including COVID vaccine royalties, milestones from the CIC/flu combo vaccine, or new collaborations, all supported by a leaner cost structure. EVP, Head of Research & Development Ruxandra Draghia-Akli explained that while a true multi-year universal flu vaccine remains an elusive goal, Novavax's technology shows promise for broader and more durable protection within a single season, which would be a significant scientific advance.

Asked about the opportunity to leverage their sales force for other companies' products and for a historical parallel (Merck's ZETIA combo) to understand the growth potential of their new triple combination.

Answer

The company sees a significant opportunity in leveraging its commercial infrastructure for other assets. They cited the success of combination therapies in Europe and the growing acceptance of the 'polypill' strategy as strong indicators for the potential of their triple combo, which market research supports.

Asked about the Medicare negotiation process, specifically if achieving preferred status involves hard negotiations, the average co-pay for Medicare versus commercial patients, and whether the initial payer agreement is critical for setting long-term co-pays.

Answer

Executives explained that achieving preferred status in Medicare was crucial and has lowered the average patient co-pay to around $45, down from over $150. Commercial co-pays are around $25 with a co-pay card. They highlighted that payers implemented these favorable changes unusually quickly, reflecting the product's strong clinical data and securing a competitive market access position.

Questioned the company's decision to use fRNA over the more common ASOs for its nucleic acid therapies. Also inquired about the potential for the blood-brain barrier shuttle technology to be part of M&A or out-licensing deals for non-dilutive funding.

Answer

The company believes fRNA is an emerging technology with potential advantages in efficacy and safety over ASOs, and they will have more data in the coming months. Regarding business development, there is significant inbound interest in their versatile ABC platform, and they see it as a valuable asset for potential partnerships, as few companies have mature blood-brain barrier technology.

Tom Shrader of BTIG inquired about the current medical practice and reimbursement landscape for administering a booster PCV shot to adults at age 65 who were previously vaccinated at age 50, and whether a formal ACIP recommendation is essential.

Answer

CEO Grant Pickering and EVP & COO Jim Wassil explained that while a booster at 65 is not yet codified, ACIP discussions and historical precedent with multi-dose vaccine schedules suggest it is the likely future direction, pending data from newer vaccines like Vaxcyte's. They noted that reimbursement for multiple doses has not been a significant issue, and the high return on investment for vaccines often leads to administration upon patient request within the appropriate age groups.

Tom Shrader asked if ADX-2191 will use the same formulation, dosing, and pricing across its different indications, such as cancer (PVRL) and prophylaxis (PVR).

Answer

President & CEO Dr. Todd Brady confirmed that the formulation and concentration of ADX-2191 will be the same across indications, highlighting its unique vitreous-compatible design. However, he noted that the dosing regimen will differ, with PVR involving a set number of injections and lymphoma potentially requiring lifelong monthly dosing. He stated that pricing is still to be determined and will depend in part on which indication is approved first.

Tom Shrader from BTIG asked about the extent of FDA buy-in for using the new marginal zone lymphoma cohort to support an accelerated approval pathway. He also posed a broader question about the potential for a solid tumor basket trial for Voruciclib, given its mechanism of MYC inhibition.

Answer

President and CEO Dan Gold explained that while the FDA is aware of their plans, any potential for accelerated approval for the marginal zone cohort will ultimately be driven by the strength of the clinical data. Regarding Voruciclib, Gold confirmed that its potential in solid tumors, particularly those with KRAS mutations where MYC is implicated, is an area of interest that the company is actively exploring with preclinical work.