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What were the key takeaways from ALX Oncology’s earnings call?

- **$150M Financing Boosts Cash to $188.7M**: Sufficient for clinical trials through mid-2028.
- **EVO Phase II Breast Trial Expanded to 120 Patients**: Focused on CD47-high subset with 65% response rate in gastric cancer.
- **ALX-2004 Safety Data Expected H2 2026**: ADC shows no ILD/skin toxicity in preclinical studies.
- **CD47 Biomarker Validation**: 92% CR in NHL, 56% response in breast cancer trials; post-ENHERTU patients have higher CD47 expression.

**【CEO Opening Remarks】**
- Announced $150 million financing, strengthening cash to $140.4 million post-offering, supporting clinical trials through mid-2028.
- Highlighted evorpacept (EVO) and ALX-2004 progress: EVO Phase II breast trial on track for 80-patient data in mid-2027; ALX-2004 Phase I safety data expected H2 2026.
- Emphasized CD47 as a predictive biomarker, with EVO showing 65% response rate in CD47-high gastric cancer vs 26% control.

**【CMO Clinical Updates】**
- **EVO Updates**: Phase II ASPEN-09 breast trial expanded to 120 patients, primary endpoint shifted to response rate in CD47-high patients. Full biomarker analysis from Phase I/II zanidatamab trial to be presented at ESMO 2026. NHL data showed 92% CR in indolent lymphoma with EVO + R-squared.
- **ALX-2004 Progress**: Phase I trial enrolling in 4 mg/kg dose cohort; preclinical data shows EGFR-targeted ADC with no ILD/skin toxicity in primates. Dose escalation safety data expected H2 2026.

**【CFO Financial Commentary】**
- Q4 2025 GAAP net loss: $22.8 million (-21% YoY), driven by reduced R&D and G&A costs. Cash after financing: $188.7 million, enabling 12-18-month clinical milestones.
- 2025 R&D spend: $83.7 million (78% on EVO, 12% on ALX-2004). 2026 guidance: ~$100 million R&D, focused on Phase II/III trials.

**【Q&A Highlights】**
- **EVO Enrollment**: ASPEN-09 site activations strong; CD47-high prevalence ~50% in breast cancer. Regulatory strategy: biomarker-driven Phase III based on 2027 data.
- **ALX-2004 Safety**: Monitoring ILD/skin toxicity via CT scans; no ILD in preclinical studies. Therapeutic window: 4-6.5 mg/kg based on primate scaling.
- **CD47 Dynamics**: Post-ENHERTU patients show higher CD47 expression; chemotherapy choice unlikely to impact EVO efficacy.

ALX Oncology Holdings Inc.(ALXO)-20260227-2025 Q4 Earnings call transcript

- **CD47 Biomarker Breakthrough**: 65% ORR in CD47 high gastric cancer patients vs. 26% control, validating targeted IL-2 strategy.
- **Pipeline Momentum**: ALX2004 Phase I ADC enrolling, with 2026 interim data and $2B market potential.
- **Financial Strength**: $67M cash runway to Q1 2027, supporting dual Phase II/III milestones.
- **Strategic Focus**: Evorpacept breast cancer trial targeting 80 patients, with 35%+ ORR vs. 20% control arm.

**【CEO Summary Section】**
- Q3 2025 revenue growth driven by CD47 biomarker validation in gastric cancer trials, with 65% ORR in CD47 high patients vs. 26% in control arm.
- Evorpacept Phase II breast cancer trial expected to dose first patient in Q4 2025, targeting CD47 high HER2+ patients post ENHERTU failure.
- ALX2004 EGFR-targeted ADC enrolling in Phase I trial, with first patient dosed in August 2025 and interim safety data expected H1 2026.
- Cash balance of $67M, providing runway to Q1 2027.

**【CFO Financial Commentary】**
- GAAP net income of $420M, with strong cost control and 5% YoY operating expense reduction.
- Evorpacept CD47 high biomarker strategy validated in 7,000+ patients, showing 2x survival benefit in CD47 high vs. low groups.
- ALX2004 Phase I trial demonstrating 1mg/kg safety profile with no EGFR-related toxicity.

**【Q&A Highlights】**
- CD47 high cutoff defined as IHC3+ in ≥10% tumor cells, with 50-60% of HER2+ patients meeting threshold post ENHERTU.
- Companion diagnostic development in collaboration with partners, targeting Phase III readiness.
- Evorpacept breast cancer trial targeting 80 patients, with 35-40% ORR benchmark vs. 20% control arm.
- ALX2004 EGFR ADC Phase I trial progressing to 2mg/kg cohort, with $2B-$4B market potential in EGFR+ solid tumors.
- CD47 overexpression identified as resistance mechanism post ENHERTU, positioning evorpacept as first-line salvage therapy.


ALX Oncology Holdings Inc. (ALXO) Q3 2025 Earnings Call Transcript

- **CD47 Biomarker Breakthrough**: Evorpacept achieves 65% ORR in CD47-high/HER2-positive gastric cancer patients, driving a biomarker-driven strategy for breast cancer expansion.
- **$2-4B Market Opportunity**: 20,000 addressable breast cancer patients with CD47-high/HER2-positive status, targeting post-ENHERTU relapse.
- **ALX2004 Milestone**: First patient dosing in Q3 2023, with safety data expected mid-2024.
- **Extended Cash Runway**: $270M+ cash to Q1 2027, supporting key programs without dilution.

**【CEO Opening Remarks】**
- Announced new data from the ASPEN-06 trial showing CD47 expression as a predictive biomarker for evorpacept efficacy in HER2-positive gastric cancer.
- Highlighted the potential to expand evorpacept into breast cancer and other CD47-overexpressing tumor types.
- Updated guidance on extended cash runway to Q1 2027, enabling focus on key programs (evorpacept in breast cancer and ALX2004).

**【CMO Clinical Update】**
- In ASPEN-06, CD47-high patients achieved 65% ORR vs. 26% in the control arm (p < 0.05), with durable responses across DOR, PFS, and OS.
- Amended Phase II breast cancer trial to prioritize CD47-high/HER2-positive patients, with interim data expected Q3 2026.
- Preclinical data shows CD47 upregulation in HER2-positive breast cancer post-ENHERTU treatment, supporting biomarker-driven strategy.

**【CFO Financial Update】**
- Extended cash runway to Q1 2027 by halting the evorpacept colon cancer program and optimizing clinical trial spend.
- ALX2004 on track to dose first patient in Q3 2023, with initial safety data expected H1 2024.
- Focus on high-value data milestones, including CD47 biomarker validation and ALX2004 proof-of-concept.

**【Q&A Highlights】**
- FDA has approved the amended ASPEN-Breast trial protocol, with no regulatory barriers to implementation.
- Clinicians express enthusiasm for CD47 biomarker strategy, citing unmet need in post-ENHERTU breast cancer.
- Interim data from ASPEN-Breast will focus on response rates ≥40%, with durability as a secondary endpoint.
- CD47 cutoff thresholds will be determined post hoc based on ASPEN-06 data, with no prespecified value in the breast trial.

Actual	-0.5158	-0.36	-0.5	-0.35	-0.4	-0.61	-0.7	-0.6	-0.81	-0.87	-0.75	-0.74	-0.84	-1.24	-0.93	-0.71	-0.76	-0.58	-0.55	-0.58	-0.49	-0.41	-0.42
Forecast	-0.3205	-0.346	-0.3467	-0.4112	-0.4365	-0.4758	-0.6116	-0.7122	-0.6336	-0.7733	-0.8863	-0.8026	-0.88	-0.852	-0.8767	-0.8172	-0.7483	-0.78	-0.67	-0.4638	-0.422	-0.3667	-0.4
Surprise	-60.94%	-4.05%	-44.22%	+14.88%	+8.36%	-28.21%	-14.45%	+15.75%	-27.84%	-12.50%	+15.38%	+7.80%	+4.55%	-45.54%	-6.08%	+13.12%	-1.56%	+25.64%	+17.91%	-25.05%	-16.11%	-11.81%	-5.00%

Actual	527.00K	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Forecast	550.00K	250.00K	-36.40K	131.00K	105.40K	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Surprise	-4.18%	-100.00%	+100.00%	-100.00%	-100.00%	0.00%	0.00%	0.00%	0.00%	0.00%	0.00%	0.00%	0.00%	0.00%	0.00%	0.00%	0.00%	0.00%	0.00%	0.00%	0.00%	0.00%	0.00%

ALXO

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ALXO

ALXO fundamentals

ALXO Q4 2025 Earnings

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