ALX ONCOLOGY HOLDINGS INC
For the period ended Sep 30, 2025. Filed Nov 7, 2025.
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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.
Sep 30, 2025 · Filed Nov 7, 2025
ALXO$1.16+0.4%Stored close · as of Nov 6, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious 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 OperationsCurrent report: 10-Q
Period ended 2025-09-30; filed 2025-11-07.
0001193125-25-272281
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsThe 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 212 previous paragraphs and 203 current paragraphs.
153 unchanged; 42 reworded; 6 added; 15 removed; 2 previous and 2 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 (6)
Current report
In patients with retained HER2-positive and CD47-high gastric cancer (n=43), Evo-TRP had a 65.0% objective response rate (ORR) versus 26.1% ORR for TRP, while patients with retained HER2-positive and CD47-low gastric cancer (n=47), Evo-TRP had a 37.5% ORR compared to 26.1% ORR for TRP.
Current report
The duration of response (DOR) was three times longer in the Evo-TRP arm relative to TRP in these patients. Evo-TRP had a median DOR (mDOR) of 25.5 months versus 8.4 months mDOR for TRP, while patients with retained HER2-positive and CD47-low gastric cancer, had an mDOR of 11.2 months for Evo-TRP compared to 12 months for TRP. Progression free survival (PFS) and overall survival (OS) data were evaluated in these patients. Treatment with Evo-TRP resulted in a PFS of 18.4 months versus 7.0 months for TRP, hazard ratio (HR) of 0.39. Treatment with Evo-TRP resulted in an OS of 17 months versus 9.9 months for TRP, HR of 0.63.
Current report
In November 2025, we will present a pre-planned exploratory analysis of the ASPEN-06 clinical trial in gastric cancer in which CD47 overexpression was identified as a key predictive biomarker for response and durable benefit in patients with retained HER2 expression.
Current report
In patients with retained HER2-positive and CD47-high gastric cancer (n=43), Evo-TRP had a 65.0% ORR versus 26.1% ORR for TRP, while patients with retained HER2-positive and CD47-low gastric cancer (n=47), Evo-TRP had a 37.5% ORR compared to 26.1% ORR for TRP.
Current report
The DOR was three times longer in the Evo-TRP arm relative to TRP in these patients. Evo-TRP had an mDOR of 25.5 months versus 8.4 months mDOR for TRP, while patients with retained HER2-positive and CD47-low gastric cancer, had an mDOR of 11.2 months for Evo-TRP compared to 12 months for TRP. PFS and OS data were evaluated in these patients. Treatment with Evo-TRP resulted in a PFS of 18.4 months versus 7.0 months for TRP, HR of 0.39. Treatment with Evo-TRP resulted in an OS of 17 months versus 9.9 months for TRP, HR of 0.63.
Current report
In August 2025, we announced the dosing of the first patient in the first-in-human, open-label multi-center Phase 1 clinical trial of ALX2004 for the treatment of advanced or metastatic select EGFR-expressing solid tumors.
Removed paragraphs (15)
Previous report
Primary endpoints (December 2024 data cutoff):
Previous report
Intent-to-treat (ITT) patient population overall response rate (ORR) (n=127): Evo-TRP demonstrated an ORR of 41.3% compared to 30% for ramucirumab and paclitaxel (RP) historical control and 26.6% for TRP control.
Previous report
Fresh HER2-positive biopsy patient population ORR (n=48): Evo-TRP demonstrated an ORR of 59.1% compared to 30% for RP historical control and 23.1% for TRP control.
Previous report
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 report
In patients with fresh HER2-positive biopsies, Evo-TRP demonstrated an mDOR of 15.7 months and mPFS of 9.5 months compared to an mDOR of 14.5 months and mPFS of 7.1 months in the TRP control group, with a PFS HR of 0.62.
Previous 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.
Previous report
Duration of response (DOR), PFS, and overall survival (OS) also showed strong magnitude of benefit for evorpacept in CD47-high patients.
Previous report
Full data set will be presented at an upcoming medical conference in the fourth quarter of 2025.
Previous report
Evo-TRP was generally well tolerated, with the incidence of adverse events in the evorpacept population consistent with those in TRP control.
Previous 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.
Previous report
DOR, PFS, and OS also showed strong magnitude of benefit for evorpacept in CD47-high patients
Previous report
Full data set will be presented at an upcoming medical conference in the fourth quarter of 2025
Previous report
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Previous report
In accordance with Nasdaq Listing Rule 5810(c)(3)(A), we have been provided a compliance period of 180 calendar days from the date of the Notice, or until October 20, 2025, to regain compliance with the minimum bid price requirement. To regain compliance with Nasdaq’s minimum bid price requirement, the closing price per share of our common stock must be at least $1.00 per share for a minimum of ten consecutive business days during the 180-calendar day compliance period, unless the Staff exercises its discretion to extend this ten-business day period. If we do not regain compliance during the 180-calendar day compliance period, we may be afforded a second 180-calendar day compliance period to regain compliance if we elect to transfer to the Nasdaq Capital Market. To qualify, we must meet the continued listing requirement for market value of publicly-held shares and all other initial listing standards for the Nasdaq Capital Market (with the exception of the minimum bid price requirement) and notify Nasdaq of our intent to cure the deficiency. If we do not regain compliance within the allotted compliance periods, including any extensions that may be granted by Nasdaq, our common stock will be subject to delisting. There can be no assurance that we will be eligible for the second compliance period, if applicable, or that the Staff would grant our request for continued listing subsequent to any delisting notification. If, during any compliance period, our common stock has a closing bid price of $0.10 per share or less for ten consecutive trading days, the Staff will issue a delisting determination under Nasdaq Listing Rule 5810(c)(3)(A)(iii) with respect to our common stock.
Previous report
We intend to actively monitor the closing bid price of our common stock and assess potential actions to regain compliance during the 180-calendar day compliance period, including effecting a reverse stock split, if necessary. While we are exercising diligent efforts to maintain the listing of our common stock on the Nasdaq Global Select Market, there can be no assurance that we will be able to regain or maintain compliance with the minimum bid price requirement or any other Nasdaq listing requirements.
Reworded paragraphs (42)
Previous 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.
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 clinical-stage 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 in combination with trastuzumab and chemotherapy in patients with metastatic HER2-positive breast cancer in the Phase 2 ASPEN-Breast clinical trial and is also being studied in clinical trials with other targeted anti-cancer antibodies. Cancer cells leverage CD47, a cell surface protein, as a “don’t eat me” signal to evade macrophage phagocytosis. 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. Our second pipeline candidate, ALX2004, is a novel EGFR-targeted antibody-drug conjugate with a differentiated mechanism of action entered into a Phase 1 clinical trial in August 2025.
Previous wording
Evorpacept is a next-generation CD47 blocking therapeutic that we believe has significantly enhanced properties compared to competing CD47 blocking approaches. Evorpacept is a fusion protein that combines a high-affinity CD47 binding domain with a proprietary inactivated Fc domain. The CD47 binding domain of evorpacept is an affinity enhanced extracellular domain of SIRPα, a protein that is the natural receptor to CD47 found on myeloid cells. We have engineered the Fc domain of evorpacept so that it does not provide a pro-phagocytic signal while still maintaining an antibody-like half-life for the molecule. We believe our inactive Fc approach improves tolerability when compared to other CD47 blocking approaches that have an Fc domain that engages activating receptors on macrophages, causing phagocytosis and death of healthy cells in addition to cancer cells.
Current wording
Evorpacept is a next-generation CD47 blocking therapeutic that we believe has significantly enhanced properties compared to competing CD47 blocking approaches. Evorpacept is a fusion protein that combines a high-affinity CD47 binding domain with a proprietary inactivated Fc domain. The CD47 binding domain of evorpacept is an affinity enhanced extracellular domain of SIRPα, a protein found on myeloid cells such as macrophages, that is the natural receptor to CD47. We have engineered the Fc domain of evorpacept so that it does not provide a pro-phagocytic signal while still maintaining an antibody-like half-life for the molecule. We believe our inactive Fc approach improves tolerability when compared to other CD47 blocking approaches that have an Fc domain that engages activating receptors on macrophages, causing phagocytosis and death of healthy cells in addition to cancer cells.
Previous wording
Evorpacept’s design has several additional advantages that we believe will make it broadly applicable to treating a number of oncology indications. Due to the inactive Fc, evorpacept is specifically designed for use in combination with other anti-cancer agents that provide a positive immune-stimulating signal. We believe evorpacept has a favorable tolerability profile that may enable higher dosing levels and greater combination potential with other leading anti-cancer agents.
Current wording
Evorpacept’s design has several additional advantages that we believe will make it broadly applicable to treating a number of oncology indications. Due to the inactive Fc, evorpacept is specifically designed for use in combination with other anti-cancer agents that provide a positive immune-stimulating signal. We believe evorpacept has a favorable tolerability profile that may enable higher dosing levels, increased tumor penetration, and greater combination potential with other leading anti-cancer agents.
Previous wording
Data from the randomized ASPEN-06 Phase 2 clinical trial supports the clinical validation of this mechanism of action. ASPEN-06 evaluates the contribution of evorpacept to HERCEPTIN®(trastuzumab) plus standard of care (CYRAMZA® (ramucirumab) + paclitaxel) (Evo-TRP), versus trastuzumab, ramucirumab, and paclitaxel (TRP) in second line or later human epidermal growth factor receptor 2 (HER2)-positive gastric/gastroesophageal junction (GEJ) cancer, where all patients had received an anti-HER2 agent in prior lines of therapy. Results from the December 2024 data cutoff were presented at an oral presentation at the 2025 American Society of Clinical Oncology (ASCO) Gastrointestinal Cancers Symposium:
Current wording
Data from the randomized ASPEN-06 Phase 2 clinical trial supports the clinical validation of this mechanism of action. ASPEN-06 evaluates the contribution of evorpacept to HERCEPTIN®(trastuzumab) plus standard of care (CYRAMZA® (ramucirumab) + paclitaxel) (Evo-TRP), versus trastuzumab, ramucirumab, and paclitaxel (TRP) in second line or later human epidermal growth factor receptor 2 (HER2)-positive gastric/gastroesophageal junction (GEJ) cancer, where all patients had received an anti-HER2 agent in prior lines of therapy. The full data set was previously presented. Results from a pre-planned exploratory analysis will be presented at the Society for Immunotherapy of Cancer (SITC) Annual Meeting:
Previous wording
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 wording
In a 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 in patients with retained HER2 expression. Retained HER2 expression is defined as patients who are HER-2 positive on a tumor biopsy after receiving a HER2-targeted treatment or by HER2 amplification by circulating tumor DNA (ctDNA). The data will be highlighted as part of a poster presentation at the SITC Annual Meeting on November 8th.
Previous wording
Our earlier ASPEN-01 Phase 1 positive data in combination with rituximab in non-Hodgkin lymphoma (NHL) and the recent clinical data of our investigator-sponsored trial (IST) collaborator from the ongoing Phase 1/2 IST of evorpacept in combination with rituximab and lenalidomide patients with relapsed refractory B-cell NHL (R/R B-NHL) provide additional support for the clinical validation of this mechanism of action and support exploring combinations of evorpacept with other anti-cancer antibodies.
Current wording
Evorpacept has been combined in clinical trials with multiple anti-cancer antibodies in addition to trastuzumab. Our earlier ASPEN-01 Phase 1 positive data in combination with rituximab in non-Hodgkin lymphoma (NHL) and the recent clinical data of our investigator-sponsored trial (IST) collaborator from the ongoing Phase 1/2 IST of evorpacept in combination with rituximab and lenalidomide patients with relapsed refractory B-cell NHL (R/R B-NHL) provide additional support for the clinical validation of this mechanism of action and support exploring combinations of evorpacept with other anti-cancer antibodies.
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 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.
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 a matuzumab-derived affinity-selected 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
In January 2025, we presented updated results from the ASPEN-06 Phase 2 clinical trial in an oral presentation at the 2025 ASCO Gastrointestinal Cancers Symposium. A confirmed ORR of 41.3% was demonstrated for the Evo-TRP treatment arm compared to 26.6% for the TRP control arm in the ITT patient population. In patients with confirmed HER2-positive expression as determined by either fresh biopsy or ctDNA HER2-positivity (n=96), the addition of evorpacept to TRP resulted in a 48.9% ORR, an mDOR of 15.7 months and mPFS of 7.5 months, compared to a 24.5% ORR, an mDOR of 9.1 months and mPFS of 6.7 months in the TRP control group, with a PFS HR of 0.64.
Current wording
In January 2025, we presented updated results from the ASPEN-06 Phase 2 clinical trial in an oral presentation at the 2025 American Society of Clinical Oncology Gastrointestinal Cancers Symposium. A confirmed ORR of 41.3% was demonstrated for the Evo-TRP treatment arm compared to 26.6% for the TRP control arm in the intent-to-treat patient population. In patients with confirmed HER2-positive expression as determined by either fresh biopsy or ctDNA HER2-positivity (n=96), the addition of evorpacept to TRP resulted in a 48.9% ORR, an mDOR of 15.7 months and median progression free survival (mPFS) of 7.5 months, compared to a 24.5% ORR, an mDOR of 9.1 months and mPFS of 6.7 months in the TRP control group, with a PFS HR of 0.64.
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)
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) showed the greatest anti-tumor activity with a confirmed ORR of 55.6% and an 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 mDOR 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. The combination therapy was well tolerated with a manageable safety profile that was consistent with prior experience of each agent.
Previous 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.
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 mDOR was not reached.
Previous wording
In April 2025, final data for the Phase 1 portion of the MD Anderson Cancer Center IST was presented at the 2025 AACR Annual Meeting. In the total population (n=20), after a median follow-up of 28 months (95% CI, 18-28 months) the two-year progression-free survival (PFS) rate was 69% and two-year OS rate was 84%. The Phase 2 portion of the clinical trial in patients with previously untreated indolent NHL is ongoing and has completed enrollment.
Current wording
In April 2025, final data for the Phase 1 portion of the MD Anderson Cancer Center IST was presented at the 2025 AACR Annual Meeting. In the total population (n=20), after a median follow-up of 28 months (95% CI, 18-28 months) the two-year PFS rate was 69% and two-year OS rate was 84%. The Phase 2 portion of the clinical trial in patients with previously untreated indolent NHL is ongoing and has completed enrollment.
Previous wording
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 wording
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.
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 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 a matuzumab-derived affinity-selected 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 $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.
Current wording
We have incurred net losses in each year since inception. Our net losses were $22.1 million and $30.7 million for the three months ended September 30, 2025 and 2024, respectively, and $78.8 million and $105.7 million for the nine months ended September 30, 2025 and 2024, respectively. As of September 30, 2025, we had an accumulated deficit of $700.0 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
On April 23, 2025, we received a written notice (Notice), from the Listing Qualifications Staff (Staff) of The Nasdaq Stock Market LLC (Nasdaq) notifying us that we have not been in compliance with the minimum bid price requirement for continued listing on the Nasdaq Global Select Market set forth in Nasdaq Listing Rule 5450(a)(1) for a period of 30 consecutive business days. The Notice has no immediate effect on the listing of our common stock on the Nasdaq Global Select Market, subject to our compliance with the other listing requirements of Nasdaq.
Current wording
On April 23, 2025, we received a written notice (Notice), from the Listing Qualifications Staff (Staff) of The Nasdaq Stock Market LLC (Nasdaq) notifying us that we had not been in compliance with the minimum bid price requirement for continued listing on the Nasdaq Global Select Market set forth in Nasdaq Listing Rule 5450(a)(1) for a period of 30 consecutive business days. The Notice had no immediate effect on the listing of our common stock on the Nasdaq Global Select Market, subject to our compliance with the other listing requirements of Nasdaq. In September 2025, we received written confirmation from the Staff of Nasdaq that we had regained compliance with the minimum bid price requirement for continued listing on the Nasdaq Global Select Market, as the closing bid price of our common stock had been at $1.00 per share or greater for ten consecutive business days.
Previous 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.
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 clinical trials 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
Almost all of our research and development expenses to date have been related to the clinical development of our lead product candidate, evorpacept, and the initiation and advancement of ALX2004. We expect to incur significant research and development expenses in the foreseeable future as we continue to invest in research and development activities related to progress on our existing product candidates. As our product candidates advance into later stages of development, we begin to conduct larger clinical trials. The process of conducting the necessary clinical trials to obtain regulatory approval is costly and time-consuming, and the successful development of our product candidates is highly uncertain. As a result, we are unable to determine the duration and completion costs of our research and development projects or when and to what extent we will generate revenue from the commercialization and sale of any of our product candidates.
Current wording
Almost all of our research and development expenses to date have been related to the clinical development of our lead product candidate, evorpacept, and the initiation and advancement of clinical trials of ALX2004. We expect to incur significant research and development expenses in the foreseeable future as we continue to invest in research and development activities related to progress on our existing product candidates. As our product candidates advance into later stages of development, we begin to conduct larger clinical trials. The process of conducting the necessary clinical trials to obtain regulatory approval is costly and time-consuming, and the successful development of our product candidates is highly uncertain. As a result, we are unable to determine the duration and completion costs of our research and development projects or when and to what extent we will generate revenue from the commercialization and sale of any of our product candidates.
Previous wording
We anticipate that our general and administrative expenses will continue to increase as a result of increased headcount, inflationary pressures, expanded infrastructure and higher costs of consulting, legal, tax and regulatory-related services associated with maintaining compliance with stock exchange listing and Securities and Exchange Commission (SEC) requirements, audit and investor relations costs, director and officer insurance premiums and other costs associated with being a public company.
Current wording
We anticipate that our general and administrative expenses will decrease as a result of the completed reduction in workforce. Other factors that may affect general administrative expenses include inflationary pressures, higher costs of consulting, legal, tax and regulatory-related services associated with maintaining compliance with stock exchange listing and Securities and Exchange Commission (SEC) requirements, audit and investor relations costs, director and officer insurance premiums and other costs associated with being a public company.
Previous wording
The following table summarizes our results of operations for the three months and six months ended June 30, 2025 and 2024 (in thousands):
Current wording
The following table summarizes our results of operations for the three months and nine months ended September 30, 2025 and 2024 (in thousands):
Previous 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):
Current wording
The following table summarizes our research and development (R&D) expenses incurred for the three months and nine months ended September 30, 2025 and 2024 (in thousands):
Previous wording
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.
Current wording
R&D expenses decreased by $9.0 million during the three months ended September 30, 2025 compared to the three months ended September 30, 2024. The decrease was primarily attributable to a decrease of $2.6 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 $3.5 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 $3.2 million in personnel and related costs primarily driven by the reduction in workforce in Q1 2025, and a decrease of $1.9 million in preclinical costs due to pipeline prioritization strategy. These decreases were offset by an increase of $2.1 million in other research costs due to a $2.5 million development milestone met related to ScalmiBio.
Previous 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.
Current wording
R&D expenses decreased by $33.5 million during the nine months ended September 30, 2025 compared to the nine months ended September 30, 2024. The decrease was primarily attributable to a decrease of $18.1 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 $9.6 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 $3.2 million in preclinical costs due to pipeline prioritization strategy, and a decrease of $3.6 million in personnel and related costs primarily driven by the reduction in workforce in Q1 2025. These decreases were offset by an increase of $0.9 million in other research costs due to an increase of $1.5 million in development milestone met related to ScalmiBio compared to the prior period offset by decreases in facility and IT costs allocated to R&D from a decrease in headcount as a result of the reduction in workforce.
Previous 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):
Current wording
The following table summarizes our general and administrative (G&A) expenses incurred for the three months and nine months ended September 30, 2025 and 2024 (in thousands):
Previous wording
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 wording
G&A expenses decreased by $1.0 million during the three months ended September 30, 2025 compared to the three months ended September 30, 2024. The decrease was primarily attributable to 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 and a decrease of $0.2 million in other G&A costs from legal consulting costs.
Previous 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.
Current wording
G&A expenses decreased by $0.5 million during the nine months ended September 30, 2025 compared to the nine months ended September 30, 2024. The decrease was primarily attributable to a decrease of $1.8 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 $0.1 million in other G&A costs from legal consulting costs. This was offset by an increase of $1.3 million in personnel and related costs primarily driven by severance costs from the reduction in workforce.
Previous wording
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.
Current wording
Impairment charge increased by zero and $3.2 million for the three months and nine months ended September 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.
Previous 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.
Current wording
Interest income decreased by $1.5 million for the three months ended September 30, 2025 compared to the three months ended September 30, 2024 and by $4.1 million for the nine months ended September 30, 2025 compared to the nine months ended September 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 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.
Current wording
Interest expense remained flat for the three months ended September 30, 2025 compared to the three months ended September 30, 2024, as well as for the nine months ended September 30, 2025 compared to the nine months ended September 30, 2024 due to similar interest rates during the periods.
Previous 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.
Current wording
Other income (expense), net remained flat for the three months ended September 30, 2025 compared to the three months ended September 30, 2024, as well as for the nine months ended September 30, 2025 compared to the nine months ended September 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 June 30, 2025, we had cash, cash equivalents and investments of $83.5 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 September 30, 2025, we had cash, cash equivalents and investments of $66.5 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 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:
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 September 30, 2025, we had an accumulated deficit of $700.0 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
macroeconomic conditions and global economic environment, such as inflation, interest rate changes, trade and other global disputes and interruptions, including related to tariffs and trade protection measures, economic downturns, bank failures or instability in the financial services sector, or geopolitical risks, disasters, and medical or public health crises, such as the COVID-19 pandemic, which may exacerbate the magnitude of the factors discussed above.
Current wording
macroeconomic conditions and global economic environment, such as inflation, interest rate changes, trade and other global disputes and interruptions, including related to tariffs and trade protection measures, duration of the U.S. federal government shutdown, economic downturns, bank failures or instability in the financial services sector, or geopolitical risks, disasters, and medical or public health crises, such as the COVID-19 pandemic, which may exacerbate the magnitude of the factors discussed above.
Previous wording
In December 2021, we entered a sales agreement (as amended, Sales Agreement) with Cantor Fitzgerald & Co. and Credit Suisse Securities (USA) LLC (Credit Suisse), under which we may offer and sell our common stock, having aggregate gross proceeds of up to $150.0 million, from time to time through them as our sales agents in our ATM offering program. In March 2022, we filed a universal shelf registration statement (2022 Shelf Registration Statement) with the SEC. In May 2022, we filed the amended 2022 Shelf Registration Statement, which was declared effective by the SEC on May 31, 2022. In August 2023, we entered into an amendment to the Sales Agreement to include UBS Securities LLC as an additional sales agent and to remove Credit Suisse as a sales agent. As of June 30, 2025, we sold an aggregate of 2,404,855 shares of common stock under our Sales Agreement for net proceeds of $30.0 million, after deducting commissions. We may terminate this ATM program and the Sales Agreement at any time, pursuant to its terms.
Current wording
In December 2021, we entered a sales agreement (as amended, Sales Agreement) with Cantor Fitzgerald & Co. and Credit Suisse Securities (USA) LLC (Credit Suisse), under which we may offer and sell our common stock, having aggregate gross proceeds of up to $150.0 million, from time to time through them as our sales agents in our ATM offering program. In March 2022, we filed a universal shelf registration statement (2022 Shelf Registration Statement) with the SEC, which was declared effective by the SEC on May 31, 2022. In August 2023, we entered into an amendment to the Sales Agreement to include UBS Securities LLC as an additional sales agent and to remove Credit Suisse as a sales agent.
Previous wording
In October 2023, we completed an underwritten follow-on public offering pursuant to the 2022 Shelf Registration Statement (the October 2023 Offering). In the follow-on public offering, we issued and sold an aggregate of 8,663,793 shares of common stock, including the underwriters’ exercise in full of their overallotment option of 1,293,103 shares of common stock, and, in lieu of common stock to certain investors, pre-funded warrants to purchase 1,250,000 shares of common stock at a public offering price of $6.38 per share and $6.379 per pre-funded warrant. Net proceeds were approximately $58.9 million, after deducting underwriting discounts and commissions of $3.8 million and offering-related expenses of $0.6 million. As of June 30, 2025, no shares underlying the pre-funded warrants had been exercised. On March 6, 2025, we filed a shelf registration statement with the SEC that became effective on April 24, 2025 (the 2025 Shelf Registration Statement). The 2025 Shelf Registration Statement replaced the 2022 Shelf Registration Statement and registered the unsold securities from the 2022 Shelf Registration Statement, including those available under the ATM program.
Current wording
In October 2023, we completed an underwritten follow-on public offering pursuant to the 2022 Shelf Registration Statement (the October 2023 Offering). In the follow-on public offering, we issued and sold an aggregate of 8,663,793 shares of common stock, including the underwriters’ exercise in full of their overallotment option of 1,293,103 shares of common stock, and, in lieu of common stock to certain investors, pre-funded warrants to purchase 1,250,000 shares of common stock at a public offering price of $6.38 per share and $6.379 per pre-funded warrant. Net proceeds were approximately $58.9 million, after deducting underwriting discounts and commissions of $3.8 million and offering-related expenses of $0.6 million. As of September 30, 2025, no shares underlying the pre-funded warrants had been exercised.
Previous 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):
Current wording
The following table presents a summary of the net cash flow activity for the nine months ended September 30, 2025 and 2024 (in thousands):
Previous 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.
Current wording
In the nine months ended September 30, 2025, net cash used in operating activities of $65.2 million was attributable to a net loss of $78.8 million and a change in our net operating assets and liabilities of $0.4 million, offset by non-cash charges of $14.1 million. The change in operating assets and liabilities was primarily due to (i) an increase in accounts payable, payable and accrued liabilities due to related party, and accrued expenses and other current liabilities of $6.1 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 $1.5 million and (iv) an increase in other assets of $5.7 million. Non-cash charges consisted primarily of stock-based compensation expense of $9.9 million, non-cash lease costs of $1.3 million, depreciation and amortization costs of $0.6 million, and impairment charge of $3.2 million offset by net amortization of premiums and accretion of discounts on investments of $1.1 million.
Previous 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.
Current wording
In the nine months ended September 30, 2024, net cash used in operating activities of $89.9 million was attributable to a net loss of $105.7 million and a change in our net operating assets and liabilities of $3.7 million, offset by non-cash charges of $19.5 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 $2.8 million primarily due to timing of invoices and payments, (ii) a decrease in other assets of $2.2 million, (iii) an increase in prepaid and other current assets of $1.4 million and (iv) a decrease in other non-current liabilities of $1.6 million. Non-cash charges consisted primarily of stock-based compensation expense of $21.2 million, non-cash lease costs of $1.3 million, and depreciation and amortization costs of $0.7 million offset by net amortization of premiums and accretion of discounts on investments of $3.9 million.
Previous 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.
Current wording
In the nine months ended September 30, 2025, net cash provided by investing activities of $71.4 million was attributable to cash received for maturities of investments of $117.1 million offset by purchases of short-term and long-term investments of $45.6 million and purchases of property and equipment of $0.2 million.
Previous 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.
Current wording
In the nine months ended September 30, 2024, net cash provided by investing activities of $53.1 million was attributable to cash received for maturities of investments of $156.4 million offset by purchases of short-term and long-term investments of $103.0 million and purchases of property and equipment of $0.4 million.
Previous 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.
Current wording
In the nine months ended September 30, 2025, net cash used in financing activities of $0.3 million was attributable to principal payments on finance leases of $0.7 million offset by proceeds from our ATM offering program of $0.4 million.
Showing the first 40 of 42 pairs. Open the source sections for the rest.
Rearranged current paragraphs (2)
Current report — wording carried from elsewhere
In August 2025, we announced that Sanofi began the dose optimization portion of the study.
Current report — wording carried from elsewhere
On March 6, 2025, we filed a shelf registration statement with the SEC that became effective on April 24, 2025 (the 2025 Shelf Registration Statement). The 2025 Shelf Registration Statement replaced the 2022 Shelf Registration Statement and registered the unsold securities from the 2022 Shelf Registration Statement, including those available under the ATM program. From December 2021 to September 30, 2025, we sold an aggregate of 2,404,855 shares of common stock under our Sales Agreement for net proceeds of $30.0 million, after deducting commissions. We may terminate this ATM program and the Sales Agreement at any time, pursuant to its terms.
Rearranged previous paragraphs (2)
Previous report — wording carried elsewhere
In patients with confirmed HER2-positive expression as determined by either fresh biopsy or circulating tumor DNA (ctDNA) HER2-positivity (n=96), the addition of evorpacept to TRP resulted in a 48.9% ORR, an mDOR of 15.7 months and mPFS of 7.5 months, compared to a 24.5% ORR, an mDOR of 9.1 months and mPFS of 6.7 months in the TRP control group, with a PFS HR of 0.64.
Previous report — wording carried 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.