CRIS

• Clinical Pipeline Progress in Hematologic Cancers

  • The registrational Take Aim lymphoma study evaluating emavucirtib in combination with ibrutinib for relapsed/refractory primary CNS lymphoma (PCNSL, a rare subtype of non-Hodgkin lymphoma) after BTK inhibitor (BTKI) progression continues to make steady, on-track enrollment progress. Updated clinical data from the study is expected in the first half of 2027, and the study design is aligned with FDA and EMA requirements to support accelerated approval submissions in both the U.S. and EU.
  • Management is advancing a new proof-of-concept combination study of emavucirtib plus Xanabrutinib for chronic lymphocytic leukemia (CLL). CLL patients on current standard-of-care BTKI monotherapy typically only achieve partial responses, require lifelong chronic treatment, and often develop BTKI-resistant mutations that lead to disease progression. The study tests the dual blockade hypothesis: adding emavucirtib (which targets an alternate NF-kappa-B driver pathway) to BTKI therapy will enable deeper responses, including complete remission or undetectable minimal residual disease (MRD), allowing for time-limited treatment and reduced resistance risk. Dosing of the first five patients is expected by mid-2026, with initial data expected in December 2026.

• Solid Tumor Clinical Update

  • In January 2026, a collaborator presented initial data from an investigator-led study of emavucirtib in combination with FOLFOX and anti-PD-1 (plus or minus Herceptin) as first-line treatment for metastatic or unresectable gastroesophageal cancer at the ASCO-GI Symposium. Data from 16 evaluable patients showed a manageable toxicity profile and encouraging preliminary efficacy results.

• Financing Update

  • QRIS completed a PIPE financing in January 2026. Up to an additional $20.2 million in gross proceeds is available from exercised of Series B warrants, triggered by public announcement of dosing the fifth CLL patient, expected later in 2026.

• The company confirms that dosing of the initial five patients in the CLL combination study will occur by mid-2026, with initial clinical data expected by December 2026. This guidance is maintained from prior announcements.
• A substantial update on PCNSL study enrollment, with a goal of full study enrollment in 2027, is expected in the first half of 2027. Updated clinical data for the PCNSL study will also be provided in the first half of 2027, maintaining prior guidance.
• With existing $15 million cash on hand plus expected potential additional proceeds from the January 2026 PIPE warrants, the company has sufficient capital to fund planned operations through the second half of 2027.
• No change to existing development timelines or milestones was announced.

QRIS is a clinical-stage biotech company with no commercial product sales as of Q1 2026. The company only reports overall corporate operating expenses with no segmented product financial performance. Aggregate financial results for Q1 2026: net loss of $24.2 million ($1.25 per diluted share), compared to a net loss of $10.6 million ($1.25 per diluted share) in Q1 2025. The larger net loss was primarily driven by a change in fair value of warrant liabilities from the January 2026 PIPE financing. Research and development (R&D) expenses were $6.4 million in Q1 2026, down from $8.5 million in Q1 2025, due to lower employee-related and manufacturing costs. General and administrative (G&A) expenses were $5.1 million in Q1 2026, up from $4.0 million in Q1 2025, primarily due to costs associated with the January 2026 PIPE financing, partially offset by lower employee-related expenses. As of March 31, 2026, QRIS held $15 million in cash and cash equivalents.

• Enrollment in the PCNSL study is inherently lumpy due to the ultra-orphan indication (very low patient population), which can cause uneven enrollment month-to-month even when the study is on track overall.
• All clinical development programs carry inherent risk that study results will not match preclinical or preliminary expectations, including failure to demonstrate improved efficacy or a manageable safety profile for emavucirtib combinations. Actual clinical results may differ materially from management's current expectations, as noted in the company's SEC filings.
• The company will need additional resources (either via further financing or a partnership) to advance its AML program into a registrational study, which creates execution and funding risk for this pipeline candidate.

Q: Sarah Nick from HC Wainwright asked how many patients have already been dosed in the CLL study, and what the current status of site activation and enrollment pace is, given the guidance of 5 patients dosed by mid-2026. / A: Management declined to provide patient-by-patient updates going forward, but confirmed that both site activation and patient enrollment are fully on track to hit the mid-2026 5-patient dosing target. Management said an update will be provided mid-2026 as planned.

Q: Miguel Jen from Laidlaw & Co. asked what the 2027 PCNSL update will cover, and whether current enrollment is meeting expectations given the lumpy enrollment pattern for this rare indication. / A: Management confirmed the first half 2027 update will cover substantial enrollment progress, with the goal of full study enrollment in 2027. While monthly enrollment is indeed lumpy (with some months having zero new patients and others having 2-3 due to the small patient population), overall enrollment is on track to hit the target timeline. Management noted continued strong investigator interest in the study.

Q: Anna on behalf of Crippa Devereconda from Truist asked about the expected safety differences between the 100mg and 200mg emavucirtib doses being tested in CLL, and how the emavucirtib-BTKI combination is differentiated from existing CLL standard of care. / A: Management does not expect meaningful safety differences between 100mg and 200mg, as emavucirtib has previously been dosed as high as 500mg with manageable safety. The dose comparison is to confirm the optimal starting dose for patients. For differentiation, existing combinations of BTKIs with BCL2 inhibitors achieve higher complete response rates but carry high bone marrow and infection toxicity. The emavucirtib combination targets dual NF-kappa-B pathway blockade to achieve deeper responses without additive toxicity, addressing the key unmet need of achieving treatment-free remission for CLL patients.

Q: Dania on behalf of Boris Teker from Jones asked what specific activity endpoints the company is looking for in the initial CLL study patients, and whether the company is actively pursuing commercial partnerships for its AML program. / A: The primary initial signal of activity is a reduction in disease burden for patients who have already plateaued at partial remission on BTKI monotherapy. Longer-term goals include achieving complete remission or undetectable MRD to allow time-limited treatment. For AML, management confirmed no partnership deal is in place currently. The company is focused on using existing capital to advance PCNSL and CLL, and while partnerships are discussed routinely, a deal would only be pursued to support future advancement of the AML program into registrational development.