Allogene Therapeutics, Inc. (ALLO) Earnings

Management highlights

- Lead Program (Semacel for Large B-Cell Lymphoma) Clinical Progress * The Alpha-3 pivotal trial evaluates Semacel as first-line consolidation therapy for MRD-positive LBCL after initial frontline treatment, using an innovative trial design that triggers treatment based on MRD status rather than clinical relapse. * Interim futility analysis of the first 24 patients showed Semacel achieved a 58.3% MRD clearance rate, compared to 16.7% in the observation arm, a 41.6 percentage point absolute difference that exceeds historical thresholds linked to improved clinical outcomes. * No cases of CRS, ICANS, or treatment-related hospitalizations were observed, enabling outpatient management for the majority of patients, aligning with the goal of democratizing CAR-T access beyond specialized academic centers. * The trial is currently enrolling at over 60 global sites, with recent regulatory approval for expansion to Australia and South Korea, which will grow the total global footprint to over 80 sites. Community cancer centers contribute approximately one-third of patient screening and treatments to date. - Allo329 for Autoimmune Disease Clinical Progress * Allo329 is a first-in-human allogeneic CAR-T therapy incorporating Dagger technology to prevent premature allogeneic cell rejection, targeting CD70 to eliminate pathogenic B and T cells in autoimmune indications. * The Phase 1 resolution basket trial enrolls patients with systemic lupus erythematosus, scleroderma, and inflammatory myositis, and has treated 9 patients as of Q1 2026 across multiple dose levels and lymphodepletion cohorts. * Early, preliminary signs of clinical activity have been observed with a favorable tolerability profile, even at doses substantially lower than those tested in competing autologous and allogeneic autoimmune CAR-T programs. * Dose escalation is ongoing, with a full data update planned for Q4 2026. - Corporate and Financial Operational Highlights * A $200.4 million gross proceeds public offering completed in April 2026 extended the company's cash runway into the first quarter of 2029.

Guidance

- 2026 operating cash expense guidance was increased modestly from approximately $150 million to $165 million, reflecting the current forecast for the Alpha-3 trial execution timeline. - 2026 GAAP operating expense guidance was also slightly increased from approximately $210 million to $225 million, which includes an estimated $35 million in non-cash stock-based compensation. - All guidance excludes potential impacts from future business development activities. - Key forward clinical milestones: interim EFS analysis for Alpha-3 is expected in mid-2027, primary analysis in mid-2028, with a BLA filing planned as soon as possible after trial results are available; a comprehensive Allo329 Phase 1 data update is expected in Q4 2026.

Segment performance

Allotine Therapeutics is a clinical-stage biotech company with no commercial product revenue as of Q1 2026. All operating activity is focused on two clinical-stage product programs: Semacel (lead oncology program) and Allo329 (early-stage autoimmune program). For Q1 2026, overall operating expenses were as follows: R&D expenses totaled $32 million (including $2.7 million in non-cash stock-based compensation), G&A expenses totaled $14.1 million (including $5.6 million in non-cash stock-based compensation). The net loss for Q1 2026 was $42.6 million, or 18 cents per share (including $8.3 million in total non-cash stock-based compensation). As of March 31, 2026, the company held $266.9 million in cash, cash equivalents, and investments.

Risks & headwinds

- All data released to date for both Semacel and Allo329 is early and preliminary. The MRD clearance signal observed in the Alpha-3 interim futility analysis has not yet been validated for improved event-free survival (EFS) or long-term clinical outcomes, which will only be confirmed in future planned interim and final analyses. - Early signs of clinical activity and tolerability for Allo329 are preliminary, and the benefit-risk profile of the program will not be established until higher dose levels are evaluated and longer patient follow-up is completed. - All forward-looking statements regarding trial timelines, clinical success, regulatory milestones, and financial performance are inherently uncertain, and are based on current assumptions that are subject to change. Additional risks are outlined in the company's SEC disclosure documents and Q1 2026 press release.

Analyst Q&A

• Q: What has been the change in Alpha-3 enrollment and site engagement after the positive interim MRD data, and what are the observed B-cell reduction differences across Allo329 lymphodepletion cohorts?

  A: Positive interim data has already driven qualitative growth in interest, with many new sites (including sites that previously declined participation) requesting to join the trial. Screening and enrollment were already strong prior to the announcement, and management expects further quantitative increases going forward. For Allo329, full details on activity and cohort differences will be held for the Q4 2026 comprehensive update, but encouraging early signals have been seen in both lymphodepletion and non-lymphodepletion cohorts, and enrollment remains on track per protocol.

• Q: What safety profile is the team targeting for Allo329, what can we expect from the Q4 2026 update, and will it include higher dose levels beyond 20 and 40 million cells?

  A: Management is targeting a clean safety profile that allows fully outpatient administration and management, mirroring the favorable safety seen in Alpha-3 to date. By Q4 2026, the update will include data from the next 80 million cell dose level, and possibly an even higher dose, with data for both cyclophosphamide lymphodepletion and no lymphodepletion cohorts, across a mix of all three indications in the basket trial. The target enrollment increase on ClinicalTrials.gov was purely an administrative clerical change with no impact to study design.

• Q: What feedback has the team received from community cancer centers post-Alpha-3 interim data, and how is Allo329 enrollment progressing amid competing autoimmune CAR-T programs?

  A: Feedback from community practices has been overwhelmingly positive, with existing participating sites already requesting to add additional trial sites within their networks. The program addresses a key gap for community physicians, who can now offer treatment to MRD-positive patients rather than referring them to distant specialized centers, and the clean safety profile makes outpatient management straightforward. For Allo329, site activation is nearly complete, with strong traction even in the competitive landscape, and enrollment has outpaced expectations with 9 patients dosed in the first 6 months.

• Q: Has the Alpha-3 interim MRD delta increased the probability of success for the mid-2027 interim EFS analysis, and what benchmarks is Allo329 targeting to advance?

  A: Management confirms the large MRD clearance differential has meaningfully increased the estimated probability of statistical success for the mid-2027 interim EFS analysis, as the observed signal suggests the eventual hazard ratio may be substantially lower than the 0.5 the trial was powered for. No trial design modifications are planned at this time, and the team will stick to the original protocol. For Allo329, the target profile is a one-time outpatient-administered treatment that can deliver durable remissions, which remains competitive against other emerging modalities for autoimmune disease.