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ALX ONCOLOGY HOLDINGS INC

For the period ended Jun 30, 2025. Filed Aug 12, 2025.

View on SEC.gov

About this filing

A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.

Jun 30, 2025 · Filed Aug 12, 2025

ALXO$1.16+0.4%Stored close · as of Nov 6, 2026

What changed in Management’s Discussion and Analysis?

Read the current filing

Previous report: 10-Q

Period ended 2025-03-31; filed 2025-05-08.

0000950170-25-066894

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

Current report: 10-Q

Period ended 2025-06-30; filed 2025-08-12.

0000950170-25-107303

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

The baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.

Compared 224 previous paragraphs and 212 current paragraphs.

154 unchanged; 34 reworded; 21 added; 31 removed; 5 previous and 3 current paragraphs rearranged.

Tables are not compared: 4 previous and 4 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.

A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.

Added paragraphs (21)

Current report

In this pre-planned exploratory analysis of the ASPEN-06 clinical trial in gastric cancer, CD47 overexpression was identified as a key predictive biomarker for response and durable benefit.

Current report

In confirmed HER2-positive, CD47-high gastric cancer patients (n=43), evorpacept combined with TRP achieved an objective response rate (ORR) of 65% compared to 26% with TRP alone. In contrast, in confirmed HER2-positive, CD47-low patients (n=47), evorpacept plus TRP demonstrated a 39% ORR versus 25% with TRP alone.

Current report

Duration of response (DOR), PFS, and overall survival (OS) also showed strong magnitude of benefit for evorpacept in CD47-high patients.

Current report

Full data set will be presented at an upcoming medical conference in the fourth quarter of 2025.

Current report

In August 2025, we announced that based on the magnitude of benefit in patients with high CD47 expression in HER2-positive gastric cancer, the ASPEN-Breast study in HER2-positive breast cancer evaluating evorpacept in combination with trastuzumab and chemotherapy has been amended to a single-arm design in all previously treated HER2 positive patients and will be evaluated by CD47 expression.

Current report

In August 2025, we announced topline results from pre-planned exploratory analysis of the ASPEN-06 trial in gastric cancer, where CD47 overexpression was identified as a key predictive biomarker for response and durable benefit.

Current report

In confirmed HER2-positive, CD47-high gastric cancer patients (n=43), evorpacept combined with TRP achieved an ORR of 65% compared to 26% with TRP alone. In contrast, in confirmed HER2-positive, CD47-low patients (n=47), evorpacept plus TRP demonstrated a 39% ORR versus 25% with TRP alone.

Current report

DOR, PFS, and OS also showed strong magnitude of benefit for evorpacept in CD47-high patients

Current report

Full data set will be presented at an upcoming medical conference in the fourth quarter of 2025

Current report

In August 2025, we streamlined evorpacept development program to focus our resources on the ASPEN-Breast trial and paused the ASPEN-CRC study announced earlier in March 2025.

Current report

Combination with the HER2-targeted bispecific, zanidatamab, and HER2-targeted ADC, fam-trastuzumab deruxtecan-nxki

Current report

In July 2025, Sanofi and ALX Oncology announced the dose escalation portion of the cohort testing evorpacept with isatuximab-irfc and dexamethasone within the randomized phase 1/2 UMBRELLA study in patients with previously treated multiple myeloma is complete. Sanofi will begin the dose optimization portion of the study.

Current report

Impairment charge consists of impairment of long-lived assets.

Current report

G&A expenses decreased by $1.4 million during the three months ended June 30, 2025 compared to the three months ended June 30, 2024. The decrease was primarily attributable to a decrease of $1.0 million in stock-based compensation expense due to terminations from the reduction in workforce as well as modification from the December 2024 option exchange and a decrease of $0.4 million in other G&A costs from legal consulting costs.

Current report

Impairment charge increased by $3.2 million for the three months and six months ended June 30, 2025. In May 2025, we made a decision to sublease our leased property in Palo Alto and are actively marketing the leased property for sublease. We recorded long-lived asset impairment charge based on the performed impairment analysis.
Removed paragraphs (31)

Previous report

We are focused on evorpacept development with the standard-of-care agents, revolving around these two cell types: macrophages and dendritic cells. We initially pursued, and continue to pursue, development of evorpacept based on two well-validated mechanisms of action involving SIRP alpha expression on macrophages and dendritic cells as discussed below.

Previous report

The distinct mechanism of actions and examples of the combinations of priority are:

Previous report

This mechanism of action may also apply to antibody-drug conjugates (ADCs), which are being investigated in two separate Phase 1 trials: one in combination with PADCEV® (enfortumab vedotin-ejfv) in patients with urothelial cancer (ASPEN-07), and the other in combination with ENHERTU® (fam-trastuzumab deruxtecan-nxki) in patients with unresectable or metastatic HER2-positive and HER2-low breast cancer.

Previous report

PD-1/programmed death-ligand 1 (PD-L1) immune checkpoint inhibitors (the “don’t activate T-cells” signal): Combining with PD-1/PD-L1 checkpoint inhibitor, where evorpacept activates dendritic cells that are constitutively inhibited by the CD47/ SIRP alpha pathway.

Previous report

In February 2023, we announced the dosing of the first patient in the ASPEN-07 trial, a Phase 1 study evaluating evorpacept in combination with an ADC, enfortumab vedotin-ejfv (EV), for the second-line treatment of locally advanced or metastatic UC.

Previous report

In June 2024, interim Phase 1 data were presented in a poster presentation at the 2024 ASCO Annual Meeting. The ASCO poster presentation data-cut reported an unconfirmed ORR of 59% (n=22) with evorpacept plus EV (EV single agent ORR benchmark is 41%). Following the April data cut-off, four additional response evaluable patients yielded an unconfirmed ORR of 61% (n=26) including two confirmed complete responses and six confirmed partial responses. These findings represent the first evorpacept combination data with an ADC from ASPEN-07’s ongoing, open-label, single-arm, clinical trial of evorpacept in combination with EV in patients with locally advanced or metastatic urothelial cancer. Continued follow-up for patients who are EV-naïve on ASPEN-07 is ongoing.

Previous report

In May 2025, we made the decision to discontinue evaluation of evorpacept in combination with EV in urothelial cancer based on the final data analysis showing that, in the ASPEN-07 trial, the addition of evorpacept to treatment with EV did not meet the bar for improved efficacy.

Previous report

In May 2021, we announced the dosing of the first patient in the ASPEN-03 trial, a randomized Phase 2 trial of evorpacept in combination with pembrolizumab for the treatment of first-line advanced PD-L1 positive HNSCC.

Previous report

In July 2022, the FDA granted Fast Track designation for evorpacept in combination with pembrolizumab for first-line treatment of adult patients with metastatic or unresectable, recurrent HNSCC whose tumors express PD-L1.

Previous report

In April 2025, we announced topline data from the ASPEN-03 Phase 2 clinical trial. Evorpacept in combination with pembrolizumab did not meet the primary endpoints in the ASPEN-03 trial of improved ORR as compared to historical controls of pembrolizumab alone, as a first-line treatment in patients with advanced HNSCC. The combination of evorpacept and pembrolizumab in ASPEN-03 demonstrated a manageable safety profile and was consistent with what has been previously reported for pembrolizumab. We will no longer pursue evorpacept in combination with pembrolizumab in HNSCC.

Previous report

In February 2020, the FDA granted Fast Track designation for evorpacept in combination with pembrolizumab, platinum, and fluorouracil for the first-line treatment of adult patients with metastatic or unresectable, recurrent HNSCC.

Previous report

In July 2021, we announced the dosing of the first patient in the ASPEN-04 trial, a randomized Phase 2 trial of evorpacept in combination with pembrolizumab, platinum, and fluorouracil for the treatment of first-line advanced HNSCC.

Previous report

In April 2025, we announced topline data from the ASPEN-04 Phase 2 clinical trial. Evorpacept in combination with pembrolizumab with chemotherapy did not meet the primary endpoints in the ASPEN-04 trial of improved ORR as compared to historical controls of pembrolizumab with chemotherapy, as a first-line treatment in patients with advanced HNSCC. The combination of evorpacept and pembrolizumab with chemotherapy in ASPEN-04 demonstrated a manageable safety profile and was consistent with what has been previously reported for pembrolizumab and chemotherapy in this setting. We will no longer pursue evorpacept in combination with pembrolizumab in HNSCC.

Previous report

ALTA-002 is a collaboration between us and Tallac Therapeutics, Inc. (Tallac) that combines our company’s SIRPα antibody with Tallac’s toll-like receptor 9 (TLR9) agonist, resulting in a potent immune activator targeted to myeloid cells in the tumor to promote innate and adaptive anti-cancer immune responses. This novel Toll-like receptor agonist antibody conjugation platform (TRAAC) enables systemic delivery of targeted TLR9 activation.
Reworded paragraphs (34)

Previous wording

We are a clinical-stage immuno-oncology company focused on helping patients fight cancer. Our clinical pipeline includes two product candidates, the CD47 blocker evorpacept and an epidermal growth factor receptor (EGFR)-targeted antibody drug candidate (ADC) ALX2004. Our lead product evorpacept is currently in multiple Phase 1 and 2 clinical trials, while our product candidate ALX2004 is expected to enter human clinical trials in the near term. Cancer cells leverage CD47, a cell surface protein, as a “don’t eat me” signal to evade macrophage phagocytosis or as a “don’t activate T-cells” signal that prevents activation of T-cells by dendritic cells. We are developing evorpacept to be a next-generation checkpoint inhibitor designed to have a high affinity for CD47 and to avoid the limitations caused by hematologic toxicities inherent in other CD47 blocking approaches.

Current wording

We are a clinical-stage biotechnology company advancing a pipeline of novel therapies designed to treat cancer and extend patients’ lives. Our clinical pipeline includes two product candidates, the CD47 blocker evorpacept and an epidermal growth factor receptor (EGFR)-targeted antibody drug candidate (ADC) ALX2004. Our lead product, evorpacept, has demonstrated potential to serve as a cornerstone therapy upon which the future of immuno-oncology can be built. Evorpacept is currently being evaluated across multiple ongoing clinical trials in a wide range of cancer indications. Our second pipeline candidate, ALX2004, is a novel EGFR-targeted antibody-drug conjugate with a differentiated mechanism of action and is anticipated to enter Phase 1 trials in August 2025. Cancer cells leverage CD47, a cell surface protein, as a “don’t eat me” signal to evade macrophage phagocytosis or as a “don’t activate T-cells” signal that prevents activation of T-cells by dendritic cells. We are developing evorpacept to be a next-generation checkpoint inhibitor designed to have a high affinity for CD47 and to avoid the limitations caused by hematologic toxicities inherent in other CD47 blocking approaches.

Previous wording

Anti-cancer antibodies (the “don’t eat me” signal): Combining with anti-cancer targeted antibodies with an active Fc domain, where evorpacept enables the Fc-mediated antibody dependent phagocytosis that is impaired by the expression of CD47 on cancer cells.

Current wording

We are focused on evorpacept development with the standard-of-care agents that provide a stimulatory signal to the innate immune system. We are combining evorpacept with anti-cancer targeted antibodies with an active Fc domain, where evorpacept enables the Fc-mediated antibody dependent phagocytosis that is impaired by the expression of CD47 on cancer cells.

Previous wording

In the ITT population, Evo-TRP demonstrated a median duration of response (mDOR) of 15.7 months and a median progression-free survival (mPFS) of 7.5 months compared to an mDOR of 9.1 months and mPFS of 7.4 months in the TRP control group, with a PFS Hazard Ratio (PFS HR) in this population of 0.77.

Current wording

In the ITT population, Evo-TRP demonstrated a median duration of response (mDOR) of 15.7 months and a median progression-free survival (mPFS) of 7.5 months compared to an mDOR of 9.1 months and mPFS of 7.4 months in the TRP control group, with a progression-free survival (PFS) Hazard Ratio (PFS HR) in this population of 0.77.

Previous wording

Our second product candidate is ALX2004, a novel EGFR-targeted ADC. ALX2004 was created from our proprietary linker-payload platform and fully designed and developed in-house by our scientists. ALX2004 comprises an affinity-tuned anti-EGFR antibody backbone engineered for optimal activity as an ADC, a proprietary topoisomerase I inhibitor payload with enhanced bystander effect, and a linker with enhanced stability. EGFR is clinically validated as a therapeutic target with several U.S. Food and Drug Administration (FDA)-approved targeted antibodies and small molecules. However, there are currently no approved EGFR-targeted ADCs and early-generation attempts to develop EGFR-targeted ADCs were limited by drug design, on-target off-tumor toxicities and toxicity of older generation payloads.

Current wording

Our second product candidate is ALX2004, a novel EGFR-targeted ADC. ALX2004 was created from our proprietary linker-payload platform and fully designed and developed in-house by our scientists. ALX2004 comprises an affinity-tuned EGFR antibody backbone engineered for optimal activity as an antibody drug conjugate (ADC), a proprietary topoisomerase I inhibitor payload with enhanced bystander effect, and a linker with enhanced stability. EGFR is clinically validated as a therapeutic target with several U.S. Food and Drug Administration (FDA)-approved targeted antibodies and small molecules. However, there are currently no approved EGFR-targeted ADCs and early-generation attempts to develop EGFR-targeted ADCs were limited by drug design, on-target off-tumor toxicities and toxicity of older generation payloads.

Previous wording

We are pursuing the following clinical programs, collaborations, and investigator-sponsored trials:

Current wording

We are engaged in the following clinical programs, collaborations, and investigator-sponsored trials:

Previous wording

In October 2023, we announced positive prespecified interim Phase 2 clinical data from our ASPEN-06 clinical trial. This prespecified interim analysis reported results from 54 randomized patients with second and third line gastric/GEJ cancer, including patients previously treated with fam-trastuzumab deruxtecan-nxki and checkpoint inhibitors. A confirmed ORR of 52% was demonstrated for the Evo-TRP treatment arm compared to 22% for the

Current wording

In October 2023, we announced positive prespecified interim Phase 2 clinical data from our ASPEN-06 clinical trial. This prespecified interim analysis reported results from 54 randomized patients with second and third line gastric/GEJ cancer, including patients previously treated with fam-trastuzumab deruxtecan-nxki and checkpoint inhibitors. A confirmed ORR of 52% was demonstrated for the Evo-TRP treatment arm compared to 22% for the TRP control arm. An mDOR was not reached for the Evo-TRP treatment arm compared to 7.4 months for the control group. The safety profile of evorpacept was consistent with previous clinical trials and was well-tolerated.

Previous wording

In December 2024, Phase 1b/2 data were presented in a poster presentation at the 2024 San Antonio Breast Cancer Symposium (SABCS). The SABCS poster presentation data-cut reported on efficacy findings from all three of the part-two trial cohorts: Cohort 1 (n=21) consisted of patients with HER2-positive breast cancer who had received prior ENHERTU and also a median of six prior systemic therapies in the metastatic setting. Patients were enrolled based on local assessment of tumor samples or central assessment. Of the 21 patients enrolled in Cohort 1, nine were found to be HER2-positive based on central assessment. Cohort 2 (n=15) consisted of patients with HER2-low breast cancer who had received a median of five prior systemic therapies. Cohort 3 (n=8) consisted of patients with other HER2-expressing cancers. Patients in Cohort 1 who were HER2-positive by central assessment (n=9) showed the greatest anti-tumor activity with a confirmed ORR of 55.6% and a median progression free survival (mPFS) of 7.4 months. Overall, patients in Cohort 1 (n=21) had a confirmed ORR and mPFS of 33.3% and 3.6 months, respectively. Patients in Cohort 2 had a confirmed ORR and mPFS of 20.0% and 1.9 months, respectively. As of the August 2024 data cutoff, median follow-up was 9.6 months, with six patients still on treatment. The median duration of response was not reached for Cohort 1 patients (range: 3.6-25.9 months) and was 5.5 months for Cohort 2 patients (range: 3.6-11.0 months), with responses ongoing, including the longest observed response, in each cohort.

Current wording

In December 2024, Phase 1b/2 data were presented in a poster presentation at the 2024 San Antonio Breast Cancer Symposium (SABCS). The SABCS poster presentation data-cut reported on efficacy findings from all three of the part-two trial cohorts: Cohort 1 (n=21) consisted of patients with HER2-positive breast cancer who had received prior ENHERTU and also a median of six prior systemic therapies in the metastatic setting. Patients were enrolled based on local assessment of tumor samples or central assessment. Of the 21 patients enrolled in Cohort 1, nine were found to be HER2-positive based on central assessment. Cohort 2 (n=15) consisted of patients with HER2-low breast cancer who had received a median of five prior systemic therapies. Cohort 3 (n=8) consisted of patients with other HER2-expressing cancers. Patients in Cohort 1 who were HER2-positive by central assessment (n=9)

Previous wording

2024 American Association for Cancer Research (AACR) Annual Meeting. The Phase 1 part of the clinical trial enrolled a total of 20 patients with indolent (n=18) and aggressive (n=2) R/R B-NHL where all patients had received prior rituximab and 72% had received prior chemoimmunotherapy. Patients received evorpacept 30 mg/kg every two weeks (Q2W) (n=3) or 60 mg/kg every four weeks (Q4W) (n=17) in combination with standard R2 treatment. The regimen was well tolerated, and there were no dose-limiting toxicities. Patients with indolent R/R B-NHL (n=18) had a best ORR of 94% and a complete response rate of 83%. The median duration of response was not reached.

Current wording

In April 2024, MD Anderson Cancer Center reported clinical data from the ongoing Phase 1/2 IST of evorpacept in combination with R2 in patients with R/R B-NHL. The new data were presented in an oral presentation at the 2024 American Association for Cancer Research (AACR) Annual Meeting. The Phase 1 part of the clinical trial enrolled a total of 20 patients with indolent (n=18) and aggressive (n=2) R/R B-NHL where all patients had received prior rituximab and 72% had received prior chemoimmunotherapy. Patients received evorpacept 30 mg/kg every two weeks (Q2W) (n=3) or 60 mg/kg every four weeks (Q4W) (n=17) in combination with standard R2 treatment. The regimen was well tolerated, and there were no dose-limiting toxicities. Patients with indolent R/R B-NHL (n=18) had a best ORR of 94% and a complete response rate of 83%. The median duration of response was not reached.

Previous wording

In April 2023, we announced a collaboration with Sanofi who will sponsor and manage a Phase 1/2 trial of SARCLISA® (isatuximab), an anti-cancer antibody, and dexamethasone in combination with evorpacept for the treatment of patients with relapsed or refractory multiple myeloma. We announced the dosing of the first patient in September 2024.

Current wording

In April 2023, we announced a collaboration with Sanofi who will sponsor and manage a Phase 1/2 trial of SARCLISA® (isatuximab-irfc), an anti-cancer antibody, and dexamethasone in combination with evorpacept for the treatment of patients with relapsed or refractory multiple myeloma. We announced the dosing of the first patient in September 2024.

Previous wording

Activated dendritic cells present neoantigens to T-cells that, once activated, will kill cancer cells when the PD-1/PD-L1 inhibitory interaction is blocked by T-cell checkpoint inhibitors. The combination with a PD-1/PD-L1 checkpoint inhibitor allows maximum activity of these newly activated T-cells. This mechanism of action is being investigated in our clinical trials, ASPEN-03 and ASPEN-04, two randomized Phase 2 studies in combination with KEYTRUDA® (pembrolizumab), without or with chemotherapy, respectively, comparing to the same treatments without evorpacept, in first line head and neck squamous cell carcinoma (HNSCC). Validation of this mechanism is supported by our Phase 1 data (n=23) in the same indications and combinations where we saw an improvement in overall survival (OS) at 12 months with respect to historical data.

Current wording

Dendritic cells are also inhibited by the interaction of SIRPα with CD47. Activated dendritic cells present neoantigens to T-cells that, once activated, will kill cancer cells when the PD-1/PD-L1 inhibitory interaction is blocked by T-cell checkpoint inhibitors such as pembrolizumab.

Previous wording

ALX2004 is a novel EGFR-targeted ADC that was created from our proprietary linker-payload platform and fully designed and developed in-house by our scientists. ALX2004 comprises an affinity-tuned anti-EGFR antibody backbone engineered for optimal activity as an ADC, a proprietary topoisomerase I inhibitor payload with enhanced bystander effect, and a linker with enhanced stability.

Current wording

ALX2004 is a novel EGFR-targeted ADC that was created from our proprietary linker-payload platform and fully designed and developed in-house by our scientists. ALX2004 comprises an affinity-tuned EGFR antibody backbone engineered for optimal activity as an ADC, a proprietary topoisomerase I inhibitor payload with enhanced bystander effect, and a linker with enhanced stability.

Previous wording

We have incurred net losses in each year since inception. Our net losses were $30.8 million and $35.6 million for the three months ended March 31, 2025 and 2024, respectively. As of March 31, 2025, we had an accumulated deficit of $651.9 million. Substantially all of our operating losses are a result of expenses incurred in connection with our research and development programs, primarily evorpacept, and from general and administrative expenses associated with our operations.

Current wording

We have incurred net losses in each year since inception. Our net losses were $25.9 million and $39.4 million for the three months ended June 30, 2025 and 2024, respectively, and $56.7 million and $75.0 million for the six months ended June 30, 2025 and 2024, respectively. As of June 30, 2025, we had an accumulated deficit of $677.8 million. Substantially all of our operating losses are a result of expenses incurred in connection with our research and development programs, primarily evorpacept, and from general and administrative expenses associated with our operations.

Previous wording

Research and development expenses consist primarily of costs incurred for the development of our lead product candidate, evorpacept, which include:

Current wording

Research and development expenses consist primarily of costs incurred for the development of our lead product candidate, evorpacept, and the initiation and advancement of ALX2004, which include:

Previous wording

Our research and development expenses consist primarily of costs associated with the development of our lead product candidate, evorpacept, and include external costs, such as fees paid to consultants, central laboratories, contractors, collaborators, CMOs and CROs in connection with our preclinical and clinical development activities.

Current wording

Our research and development expenses consist primarily of costs associated with the development of our lead product candidate, evorpacept, and the initiation and advancement of ALX2004, and include external costs, such as fees paid to consultants, central laboratories, contractors, collaborators, CMOs and CROs in connection with our preclinical and clinical development activities.

Previous wording

Our interest income consists primarily of interest income on cash, cash equivalents and short-term and long-term investments.

Current wording

Our interest income consists primarily of interest income on cash, cash equivalents and investments.

Previous wording

The following table summarizes our results of operations for the three months ended March 31, 2025 and 2024 (in thousands):

Current wording

The following table summarizes our results of operations for the three months and six months ended June 30, 2025 and 2024 (in thousands):

Previous wording

The following table summarizes our research and development (R&D) expenses incurred for the three months ended March 31, 2025 and 2024 (in thousands):

Current wording

The following table summarizes our research and development (R&D) expenses incurred for the three months and six months ended June 30, 2025 and 2024 (in thousands):

Previous wording

R&D expenses decreased by $7.8 million during the three months ended March 31, 2025 compared to the three months ended March 31, 2024. The decrease was primarily attributable to a decrease of $7.0 million in clinical and development costs primarily due to manufacturing of clinical trial materials, the majority of which was completed in early 2024, to support active clinical trials for our lead product candidate, evorpacept, a decrease of $2.0 million in stock-based compensation expense due to terminations from the reduction in workforce as well as modification from the December 2024 option exchange, and a decrease of $0.9 million in other research costs due to absence of development milestone payment compared to the prior period. These decreases were offset by an increase of $1.7 million in personnel and related costs primarily driven by severance costs from the reduction in workforce and an increase of $0.4 million in preclinical costs for development of new targets.

Current wording

R&D expenses decreased by $24.5 million during the six months ended June 30, 2025 compared to the six months ended June 30, 2024. The decrease was primarily attributable to a decrease of $15.5 million in clinical and development costs primarily due to manufacturing of clinical trial materials, the majority of which was completed in early 2024, to support active clinical trials for our lead product candidate, evorpacept, a decrease of $6.1 million in stock-based compensation expense due to terminations from the reduction in workforce as well as modification from the December 2024 option exchange, a decrease of $1.3 million in preclinical costs due to pipeline prioritization strategy, a decrease of $1.1 million in other research costs due to absence of development milestone payment compared to the prior period, and a decrease of $0.4 million in personnel and related costs primarily driven by the reduction in workforce in Q1 2025.

Previous wording

The following table summarizes our general and administrative (G&A) expenses incurred for the three months ended March 31, 2025 and 2024 (in thousands):

Current wording

The following table summarizes our general and administrative (G&A) expenses incurred for the three months and six months ended June 30, 2025 and 2024 (in thousands):

Previous wording

G&A expenses increased by $1.9 million during the three months ended March 31, 2025 compared to the three months ended March 31, 2024. The increase was primarily attributable to an increase of $1.2 million in personnel and related costs primarily driven by severance costs from the reduction in workforce, an increase of $0.5 million in other G&A costs from legal consulting costs, and an increase of $0.2 million in stock-based compensation expense.

Current wording

G&A expenses increased by $0.5 million during the six months ended June 30, 2025 compared to the six months ended June 30, 2024. The increase was primarily attributable to an increase of $1.3 million in personnel and related costs primarily driven by severance costs from the reduction in workforce, offset by a decrease of $0.9 million in stock-based compensation expense due to terminations from the reduction in workforce as well as modification from the December 2024 option exchange.

Previous wording

Interest income decreased by $1.1 million for the three months ended March 31, 2025 compared to the three months ended March 31, 2024. The decrease was primarily attributable to lower cash and investment balances during 2025 as compared to 2024.

Current wording

Interest income decreased by $1.5 million for the three months ended June 30, 2025 compared to the three months ended June 30, 2024 and by $2.6 million for the six months ended June 30, 2025 compared to the six months ended June 30, 2024. The decreases were primarily attributable to lower cash and investment balances during 2025 as compared to 2024.

Previous wording

Interest expense remained flat for the three months ended March 31, 2025 compared to the three months ended March 31, 2024 due to similar interest rates during the periods.

Current wording

Interest expense remained flat for the three months ended June 30, 2025 compared to the three months ended June 30, 2024, as well as for the six months ended June 30, 2025 compared to the six months ended June 30, 2024 due to similar interest rates during the periods.

Previous wording

Other income (expense), net remained flat for the three months ended March 31, 2025 compared to the three months ended March 31, 2024.

Current wording

Other income (expense), net remained flat for the three months ended June 30, 2025 compared to the three months ended June 30, 2024, as well as for the six months ended June 30, 2025 compared to the six months ended June 30, 2024.

Previous wording

Since our inception, we have incurred significant operating losses and have not generated any product revenue. We have not yet commercialized any of our product candidates and we do not expect to generate revenue from sales of any product candidates for several years, if at all, subject to regulatory and marketing approval of any of our product candidates. To date, we have funded our operations with proceeds from the sales of shares of our common stock and convertible preferred stock and borrowings under our term loan. As of March 31, 2025, we had cash, cash equivalents and short-term and long-term investments of $107.0 million.

Current wording

Since our inception, we have incurred significant operating losses and have not generated any product revenue. We have not yet commercialized any of our product candidates and we do not expect to generate revenue from sales of any product candidates for several years, if at all, subject to regulatory and marketing approval of any of our product candidates. To date, we have funded our operations with proceeds from the sales of shares of our common stock and convertible preferred stock and borrowings under our term loan. As of June 30, 2025, we had cash, cash equivalents and investments of $83.5 million.

Previous wording

We have incurred losses and negative cash flows from operations since inception and anticipate that we will continue to incur net losses for the foreseeable future. As of March 31, 2025, we had an accumulated deficit of $651.9 million. We expect our expenses to increase substantially in connection with our ongoing activities, particularly as we advance the preclinical activities and clinical trials for our product candidates in development. In addition, we expect to incur additional costs associated with operating as a public company. Management recognizes the need to raise additional capital to fully implement its business plan. The timing and amount of such future capital requirements are difficult to forecast and will depend on many factors, including:

Current wording

We have incurred losses and negative cash flows from operations since inception and anticipate that we will continue to incur net losses for the foreseeable future. As of June 30, 2025, we had an accumulated deficit of $677.8 million. We expect our expenses to increase substantially in connection with our ongoing activities, particularly as we advance the preclinical activities and clinical trials for our product candidates in development. In addition, we expect to incur additional costs associated with operating as a public company. Management recognizes the need to raise additional capital to fully implement its business plan. The timing and amount of such future capital requirements are difficult to forecast and will depend on many factors, including:

Previous wording

We believe our existing cash, cash equivalents and investments will enable us to fund our operating expenses and capital expenditure requirements into the fourth quarter of 2026. Additionally, the Company also has the ability to further utilize the ATM program. We have based these estimates on assumptions in which actuals may materially differ, and we could utilize our available capital resources sooner than we expect.

Current wording

We believe our existing cash, cash equivalents and investments will enable us to fund our operating expenses and capital expenditure requirements into the first quarter of 2027. Additionally, the Company also has the ability to further utilize the ATM program. We have based these estimates on assumptions in which actuals may materially differ, and we could utilize our available capital resources sooner than we expect.

Previous wording

The following table presents a summary of the net cash flow activity for the three months ended March 31, 2025 and 2024 (in thousands):

Current wording

The following table presents a summary of the net cash flow activity for the six months ended June 30, 2025 and 2024 (in thousands):

Previous wording

In the three months ended March 31, 2025, net cash used in operating activities of $24.7 million was attributable to a net loss of $30.8 million, offset by a change in our net operating assets and liabilities of $0.6 million and by non-cash charges of $5.4 million. The change in operating assets and liabilities was primarily due to (i) a decrease in accounts payable, payable and accrued liabilities due to related party, and accrued expenses and other current liabilities of $0.8 million primarily due to timing of invoices and payments, (ii) a decrease in prepaid and other current assets of $1.9 million and (iii) a decrease in other non-current liabilities of $0.5 million. Non-cash charges consisted primarily of stock-based compensation expense of $5.2 million, non-cash lease costs of $0.5 million, and depreciation and amortization costs of $0.2 million offset by net amortization of premiums and accretion of discounts on investments of $0.5 million.

Current wording

In the six months ended June 30, 2025, net cash used in operating activities of $48.1 million was attributable to a net loss of $56.7 million and a change in our net operating assets and liabilities of $2.5 million, offset by non-cash charges of $11.2 million. The change in operating assets and liabilities was primarily due to (i) a decrease in accounts payable, payable and accrued liabilities due to related party, and accrued expenses and other current liabilities of $1.7 million primarily due to timing of invoices and payments, (ii) a decrease in prepaid and other current assets of $0.7 million, (iii) a decrease in other non-current liabilities of $1.0 million and (iv) an increase in other assets of $0.4 million. Non-cash charges consisted primarily of stock-based compensation expense of $7.4 million, non-cash lease costs of $0.9 million, depreciation and amortization costs of $0.4 million, and impairment charge of $3.2 million offset by net amortization of premiums and accretion of discounts on investments of $0.8 million.

Previous wording

In the three months ended March 31, 2024, net cash used in operating activities of $37.9 million was attributable to a net loss of $35.6 million and a change in our net operating assets and liabilities of $8.6 million, offset by non-cash charges of $6.2 million. The change in operating assets and liabilities was primarily due to (i) a decrease in accounts payable and accrued expenses and other current liabilities of $3.6 million primarily due to timing of invoices and payments, (ii) a decrease in other assets of $0.1 million, (iii) an increase in prepaid and other current assets of $4.5 million and (iv) a decrease in other non-current liabilities of $0.6 million. Non-cash charges consisted primarily of stock-based compensation expense of $7.0 million, non-cash lease costs of $0.4 million, and depreciation and amortization costs of $0.2 million offset by net amortization of premiums and accretion of discounts on investments of $1.6 million.

Current wording

In the six months ended June 30, 2024, net cash used in operating activities of $64.5 million was attributable to a net loss of $75.0 million and a change in our net operating assets and liabilities of $2.3 million, offset by non-cash charges of $12.8 million. The change in operating assets and liabilities was primarily due to (i) an increase in accounts payable and accrued expenses and other current liabilities of $2.9 million primarily due to timing of invoices and payments, (ii) a decrease in other assets of $1.9 million, (iii) an increase in prepaid and other current assets of $6.1 million and (iv) a decrease in other non-current liabilities of $1.1 million. Non-cash charges consisted primarily of stock-based compensation expense of $14.3 million, non-cash lease costs of $0.9 million, and depreciation and amortization costs of $0.4 million offset by net amortization of premiums and accretion of discounts on investments of $2.9 million.

Previous wording

In the three months ended March 31, 2025, net cash provided by investing activities of $27.6 million was attributable to cash received for maturities of investments of $43.5 million offset by purchases of short-term and long-term investments of $15.8 million and purchases of property and equipment of $0.1 million.

Current wording

In the six months ended June 30, 2025, net cash provided by investing activities of $50.0 million was attributable to cash received for maturities of investments of $91.2 million offset by purchases of short-term and long-term investments of $41.2 million and purchases of property and equipment of $0.1 million.

Previous wording

In the three months ended March 31, 2024, net cash provided by investing activities of $26.5 million was attributable to cash received for maturities of investments of $57.9 million offset by purchases of short-term and long-term investments of $31.3 million and purchases of property and equipment of $0.1 million.

Current wording

In the six months ended June 30, 2024, net cash provided by investing activities of $27.4 million was attributable to cash received for maturities of investments of $121.9 million offset by purchases of short-term and long-term investments of $94.2 million and purchases of property and equipment of $0.2 million.

Previous wording

In the three months ended March 31, 2025, net cash provided by financing activities of $0.1 million was attributable to proceeds from our ATM offering program of $0.4 million offset by principal payments on finance leases of $0.3 million.

Current wording

In the six months ended June 30, 2025, net cash used in financing activities of $0.2 million was attributable to principal payments on finance leases of $0.5 million offset by proceeds from our ATM offering program of $0.4 million.

Previous wording

In the three months ended March 31, 2024, net cash provided by financing activities of $3.1 million was attributable to proceeds from our ATM offering program of $3.0 million and proceeds from the exercise of stock options under equity incentive plans of $0.2 million offset by principal payments on finance leases of $0.2 million.

Current wording

In the six months ended June 30, 2024, net cash provided by financing activities of $30.2 million was attributable to proceeds from our ATM offering program of $29.2 million, proceeds from the exercise of stock options under equity incentive plans of $1.1 million, and proceeds from issuance of common stock pursuant to employee stock purchase plan of $0.3 million, offset by principal payments on finance leases of $0.4 million.

Previous wording

Our significant accounting policies and critical accounting estimates are more fully described in the notes to our audited consolidated financial statements and in the section titled “Management’s Discussion and Analysis of Financial Condition and Results of Operations—Critical Accounting Estimates,” respectively, in the Company’s Annual Report on Form 10-K for the year ended December 31, 2024. During the three months ended March 31, 2025, there were no material changes to our critical accounting policies and estimates from those discussed in the Company’s Annual Report on Form 10-K for the year ended December 31, 2024 filed with the SEC on March 6, 2025.

Current wording

Our significant accounting policies and critical accounting estimates are more fully described in the notes to our audited consolidated financial statements and in the section titled “Management’s Discussion and Analysis of Financial Condition and Results of Operations—Critical Accounting Estimates,” respectively, in the Company’s Annual Report on Form 10-K for the year ended December 31, 2024. During the six months ended June 30, 2025, there were no material changes to our critical accounting policies and estimates from those discussed in the Company’s Annual Report on Form 10-K for the year ended December 31, 2024 filed with the SEC on March 6, 2025.
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Current report — wording carried from elsewhere

Combination with the EGFR-targeted antibody cetuximab

Current report — wording carried from elsewhere

showed the greatest anti-tumor activity with a confirmed ORR of 55.6% and a median progression free survival (mPFS) of 7.4 months. Overall, patients in Cohort 1 (n=21) had a confirmed ORR and mPFS of 33.3% and 3.6 months, respectively. Patients in Cohort 2 had a confirmed ORR and mPFS of 20.0% and 1.9 months, respectively. As of the August 2024 data cutoff, median follow-up was 9.6 months, with six patients still on treatment. The median duration of response was not reached for Cohort 1 patients (range: 3.6-25.9 months) and was 5.5 months for Cohort 2 patients (range: 3.6-11.0 months), with responses ongoing, including the longest observed response, in each cohort.

Current report — wording carried from elsewhere

R&D expenses decreased by $16.6 million during the three months ended June 30, 2025 compared to the three months ended June 30, 2024. The decrease was primarily attributable to a decrease of $8.5 million in clinical and development costs primarily due to manufacturing of clinical trial materials, the majority of which was completed in early 2024, to support active clinical trials for our lead product candidate, evorpacept, a decrease of $4.1 million in stock-based compensation expense due to terminations from the reduction in workforce as well as modification from the December 2024 option exchange, a decrease of $2.1 million in personnel and related costs primarily driven by the reduction in workforce in Q1 2025, a decrease of $1.7 million in preclinical costs due to pipeline prioritization strategy, and a decrease of $0.2 million in other research costs.
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Previous report — wording carried elsewhere

TRP control arm. An mDOR was not reached for the Evo-TRP treatment arm compared to 7.4 months for the control group. The safety profile of evorpacept was consistent with previous clinical trials and was well-tolerated.

Previous report — wording carried elsewhere

Combination with antibody-drug conjugate (ADC)

Previous report — wording carried elsewhere

In April 2024, MD Anderson Cancer Center reported clinical data from the ongoing Phase 1/2 IST of evorpacept in combination with R2 in patients with R/R B-NHL. The new data were presented in an oral presentation at the

Previous report — wording carried elsewhere

Combination with PD-1/PD-L1 immune checkpoint inhibitor

Previous report — wording carried elsewhere

In February 2024, we filed an investigative new drug (IND) application for ALTA-002 and in March 2024, the FDA cleared the IND to evaluate ALTA-002 in a Phase 1 clinical trial for patients with advanced solid tumors.