Pyxis Oncology, Inc.
For the period ended Mar 31, 2026. Filed May 14, 2026.
View on SEC.govAbout 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.
Mar 31, 2026 · Filed May 14, 2026
PYXS$1.66+3.1%Stored close · as of Nov 6, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2025-09-30; filed 2025-11-03.
0001193125-25-261696
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2026-03-31; filed 2026-05-14.
0001193125-26-222843
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 128 previous paragraphs and 124 current paragraphs.
52 unchanged; 35 reworded; 35 added; 37 removed; 4 previous and 2 current paragraphs rearranged.
Tables are not compared: 7 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 (35)
Current report
Our lead product candidate, micvotabart pelidotin (MICVO, formerly PYX-201), is an investigational novel antibody-drug conjugate (ADC) that uniquely targets the splice variant of fibronectin, extradomain-B of fibronectin (EDB+FN), a non-cellular structural component of the extracellular matrix (ECM) in the tumor microenvironment (TME). EDB+FN is an isoform of fibronectin present in tumors that is negligibly expressed in normal adult tissues and facilitates cancer progression by playing multiple roles including promoting cell proliferation, adhesion, and migration, activating the integrin signaling pathway, stimulating angiogenesis and vascular remodeling, driving epithelial-mesenchymal transition (EMT), and establishing the pre-metastatic niche. We believe EDB+FN is a compelling target for cancer therapeutics as the physiological expression of EDB+FN is very low in healthy adult tissues, yet it is found to be highly expressed in a variety of solid tumors.
Current report
Our ADC, MICVO, consists of a fully human IgG1 monoclonal antibody that is site-specifically conjugated to a cleavable linker with an optimized auristatin (Aur0101) microtubule inhibitor payload. Unlike conventional ADCs which bind to an antigen on the surface of a cancer cell, MICVO is designed to bind to EDB+FN in the tumor ECM, where extracellular proteases under acidic conditions cleave the linker to release the Aur0101 payload. The payload diffuses through the membrane of cancer cells to kill them directly, which is the first component of MICVO’s three-pronged mechanism of action (MOA). The dying cancer cells release the payload which diffuses into nearby cancer cells and kills them via the bystander effect, representing the second component of MICVO’s MOA. The dying cancer cells also release neoantigens which trigger immunogenic cell death (ICD), the final component of its MOA. Together with its purpose-built design and postulated three-pronged MOA, MICVO has the potential for improved stability and anti-tumor activity compared to conventional ADCs.
Current report
MICVO is currently being studied as monotherapy in recurrent and metastatic head and neck squamous cell carcinoma (R/M HNSCC) and in combination with KEYTRUDA® (pembrolizumab) in 1L/2L+ R/M HNSCC and other solid tumors.
Current report
MICVO Monotherapy
Current report
PYX-201-101 Phase 1 (Part 1) Monotherapy Dose Escalation Study
Current report
As part of our Phase 1 monotherapy study, referred to as PYX-201-101, we conducted a dose escalation study to evaluate MICVO monotherapy in patients with advanced solid tumors known to express EDB+FN. In November 2024, we reported positive preliminary results from the dose escalation study, which included a total of 80 patients dosed across nine solid tumor types at doses ranging from 0.3 mg/kg to 8 mg/kg, with a data cut-off of October 4, 2024. Of the nine solid tumor types included in the study, the strongest tumor regression response was observed in R/M HNSCC. Among the six efficacy evaluable heavily pre-treated patients with R/M HNSCC, the confirmed objective response rate (ORR) was 50% per RECIST v1.1 at the therapeutically active dose response range of 3.6 mg/kg – 5.4 mg/kg administered intravenously every three weeks (IV Q3W), including one confirmed complete response (CR) and two confirmed partial responses (PRs), with a disease control rate (DCR) of 100%. Based on observations from the dose-escalation study, 5.4 mg/kg IV Q3W presented an optimal benefit-risk profile within the efficacious dose range and was selected for dose expansion. Subsequent translational data indicated reduction in ctDNA TF after treatment with MICVO, particularly at the 5.4 mg/kg dose, supported a positive molecular response to MICVO, providing further validation of the dose selection strategy for dose expansion.
Current report
PYX-201-101 Phase 1 (Part 2) Monotherapy Dose Expansion in R/M HNSCC
Current report
In January 2025, we initiated the dose expansion portion (Part 2) of the Phase 1 PYX-201-101 monotherapy study to further evaluate MICVO as a monotherapy at a dose of 5.4 mg/kg IV Q3W and to assess preliminary efficacy in R/M HNSCC. The Part 2 dose-expansion phase includes the following two cohorts:
Current report
In December 2025, we reported positive preliminary data from our ongoing Phase 1 monotherapy study evaluating MICVO in patients with 2L+ R/M HNSCC, based on a data cut-off date of November 3, 2025, which included all R/M HNSCC patients dosed at 5.4 mg/kg total body weight (TBW) in Part 1 and in Part 2. As of the data cut-off, 18 R/M HNSCC patients had been treated and 13 patients were efficacy evaluable. All treated patients had received prior systemic therapy, with a median of three prior lines of therapy. All treated patients had received prior platinum-based and checkpoint inhibitor therapies while 67% of treated patients had received prior taxanes and 50% of treated patients had received prior EGFR-targeted therapies, specifically cetuximab. Among the 13 efficacy evaluable patients, the confirmed ORR was 46% (6/13, one patient confirmed response after November 3, 2025 data cut-off) per RECIST v1.1, including one confirmed complete response. Confirmed responses were observed in both dose-expansion cohorts, including patients previously treated with platinum-based therapy and anti-PD(L)1 therapy (Arm 1) and patients previously treated with an EGFR inhibitor and/or anti-PD(L)1 therapy (Arm 2), and were observed in patients regardless of HPV status. The preliminary data also showed a DCR of 92%, with 12 of 13 efficacy evaluable patients demonstrating significant tumor regression or tumor control.
Current report
Preliminary data reported in December 2025 indicated that MICVO was generally well tolerated. No Grade 4 ADC payload treatment-related adverse events (TRAEs) of interest were observed, and no Grade 5 events occurred. TRAEs were reported in 89% (16/18) of patients, with Grade ≥3 TRAEs reported in 56% (10/18) of patients. TRAEs leading to treatment discontinuation occurred in 28% (5/18) of patients. We observed a higher discontinuation rate and incidence of Grade ≥3 TRAEs in high body weight patients (defined as at least 10% above adjusted ideal body weight, or AIBW). In the preliminary dataset, all patients (5/5) who experienced TRAEs leading to treatment discontinuation had high body weight. Several approved ADCs have demonstrated comparable associations among patient body weight, systematic drug exposure, and tolerability profiles. Many of these ADCs, such as Padcev, Adcetris, and Elahere, have addressed such observations through dosing modifications that resulted in an improved tolerability profile while sustaining efficacy, including through capping the maximum allowable dose or employing AIBW dosing. We are actively evaluating both of these approaches to optimize MICVO’s benefit-risk profile.
Current report
MICVO Combination Therapy
Current report
PYX-201-102 Phase 1/2 Preliminary Combination Data in R/M HNSCC
Current report
In December 2025, we reported positive preliminary data from this study, evaluating MICVO at 3.6 mg/kg and 4.4 mg/kg IV Q3W, each administered in combination with a fixed 200 mg dose of pembrolizumab Q3W, in patients with 1L/2L+ R/M HNSCC. As of the data cut-off date of November 3, 2025, seven patients had been treated, including four patients at 3.6 mg/kg and three patients at 4.4 mg/kg of MICVO, each in combination with pembrolizumab. All treated patients had received prior systemic therapy, including four patients with 1L R/M HNSCC (median of one prior systemic therapy administered in the neoadjuvant or adjuvant setting) and three patients with 2L+ R/M HNSCC (median of three prior lines of therapy, some of which were administered prior to the R/M setting). Among the seven efficacy-evaluable patients, the confirmed ORR was 71% (5/7, one patient confirmed response after November 3, 2025 data cut-off) and the DCR was 100% (7/7), with all seven patients demonstrating meaningful tumor regression. Responses were observed across a range of PD-L1 combined positive scores (CPS), from CPS≥1 to CPS>20, and included responses in patients who had previously received checkpoint inhibitor treatment and had experienced disease progression while receiving checkpoint inhibitor treatment. Preliminary safety data indicated that MICVO in combination with pembrolizumab was generally well tolerated, with no Grade 3 or Grade 4 ADC payload TRAEs of interest and no Grade 5 events reported. TRAEs were reported in 86% (6/7) of patients. No TRAEs led to treatment discontinuation, and, as of the data cut-off date, no overlapping toxicities between MICVO and pembrolizumab (KEYTRUDA®) had been observed.
Current report
Recent Preclinical Data
Current report
In April 2026, we presented new preclinical data in a poster session at the American Association for Cancer Research (AACR) 2026 Annual Meeting in San Diego, California. The new preclinical data indicated that a mouse analogue of MICVO (maMICVO) demonstrates anti-tumor activity in a preclinical HNSCC model as monotherapy, and synergistic anti-tumor activity in combination with anti-mouse PD-1. The preclinical data are summarized below:
Current report
maMICVO produced dose-dependent inhibition of EDB+FN-expressing MOC2 tumor outgrowth, with 6 mg/kg showing the strongest tumor growth inhibition.
Current report
maMICVO monotherapy modulated the tumor-immune environment in a syngeneic preclinical model of HNSCC toward a more favorable immune-permissive environment. Treatment with maMICVO reduced the overall abundance of immune-suppressive regulatory T cells (Tregs) in MOC2 tumors. maMICVO also increased the CD8 T cell-to-Treg ratio and enhanced the abundance of a progenitor exhausted T cell subset that is highly responsive to anti-PD-1 therapy.
Current report
maMICVO in combination with anti-mouse PD-1 worked synergistically to produce greater anti-tumor activity compared with either treatment alone in an immune-refractory syngeneic preclinical model of HNSCC. The combination of maMICVO and anti-mouse PD-1 resulted in greater tumor control and tumor growth inhibition than monotherapy with either maMICVO or anti-mouse PD-1. Bliss independence analysis confirmed that maMICVO acted synergistically with anti-mouse PD-1 in a preclinical model unresponsive to anti-mouse PD-1 monotherapy.
Current report
MICVO Monotherapy Pipeline
Current report
The mid-year 2026 update will focus on participants treated at 5.4 mg/kg IV Q3W with a dose equivalent to or below a dose cap, and will include detailed analyses of the impact of dose capping on safety, tolerability, and efficacy. Dose capping and AIBW are both well-established approaches to modified weight-based dosing and have demonstrated improved tolerability without sacrificing clinical activity in studies of other ADCs. In December 2025, we implemented a dose cap for higher body weight patients. Based on internal PK simulation modeling indicating that MICVO exposure with dose capping and AIBW dosing are comparable, dose capping was prioritized for its operational simplicity and ease of implementation. A protocol amendment permitting AIBW dosing has since been approved, and AIBW dosing has begun in ongoing clinical studies. AIBW will be selected as a go-forward dose strategy only if it offers a superior profile to dose capping.
Current report
During the fourth quarter of 2025, we obtained feedback and alignment from the U.S. Food and Drug Administration (FDA) regarding the clinical trial design for a planned pivotal monotherapy study in 2L+ R/M HNSCC.
Current report
MICVO Combination Therapy Pipeline
Current report
Our Phase 1/2 combination study with KEYTRUDA® (PYX-201-102) is ongoing and we are conducting the dose escalation phase of PYX-201-102 across multiple tumor types with the objective of identifying the Recommended Phase 2 Dose (RP2D) of MICVO in combination with pembrolizumab. We are currently enrolling and dosing patients across several dose levels between 3.6 mg/kg and 5.4 mg/kg of MICVO, in combination with pembrolizumab at the fixed dose of 200 mg IV Q3W, in order to accurately characterize the RP2D for MICVO in combination with pembrolizumab, subject to ongoing safety review, enrollment progress, and clinical data evaluation.
Current report
We are on track to report updated data in the second half of 2026 from the ongoing PYX-201-102 Phase 1/2 dose escalation study evaluating MICVO in combination with KEYTRUDA®, with the update focused on patients with 1L R/M HNSCC.
Current report
Research and Development Expenses
Current report
General and Administrative Expenses
Current report
Other Income, Net
Current report
Research and Development Expenses
Current report
MICVO program-specific research and development costs increased by $5.5 million, primarily reflecting a $4.4 million increase in clinical trial-related expenses due to an increased number of patients dosed in the MICVO monotherapy and combination therapy trials, as well as an $0.8 million increase in preclinical studies.
Current report
Other program costs mainly reflects costs for storage of drug products and drug materials and intellectual property related costs.
Current report
Unallocated research and development costs decreased by $1.8 million due to decreased severance expense of $1.0 million, decreased employee recruitment costs of $0.4 million, and a reduction in other research and development support costs of $0.4 million.
Current report
General and Administrative Expenses
Current report
General and administrative expenses decreased by $1.5 million, from $5.9 million for the three months ended March 31, 2025 to $4.4 million for the three months ended March 31, 2026. This decrease was primarily attributable to a $1.8 million reduction in personnel-related expenses, mainly due to lower stock-based compensation.
Current report
Other Income, Net
Current report
There were no financing activities during the three months ended March 31, 2025.
Removed paragraphs (37)
Previous report
Our product candidate, micvotabart pelidotin (MICVO), formerly referred to as PYX-201, is an investigational novel antibody-drug conjugate (ADC) that uniquely targets Extradomain-B Fibronectin (EDB+FN), a non-cellular structural component within the tumor extracellular matrix (ECM). The tumor ECM is a complex network of fibrous proteins and molecules with unique composition that play an important role in cell development and tumor growth and in some instances, in supporting metastasis. The fibronectin strands within the ECM give the tumor shape and support the clustering of tumor cells.
Previous report
Fibronectin is a key component of the ECM and its downstream signaling pathways regulate cell adhesion, migration, differentiation and wound healing. EDB+FN is an alternatively spliced form of fibronectin. EDB+FN regulates blood vessel morphogenesis, which provides the tumor access to nutrition and oxygen, and provides a means to remove waste and a pathway for cells to metastasize. EDB+FN is a compelling target for cancer therapeutics as the physiological expression of EDB+FN is very low in healthy adult tissues, yet it is found to be highly expressed in a large variety of solid tumor tissues. EDB+FN is also found to be expressed during embryogenesis.
Previous report
By targeting EDB+FN, our goal is to destabilize the barrier that protects, feeds, and provides structure to the tumor, in addition to killing tumor cells directly while sparing healthy cells.
Previous report
Our ADC, micvotabart pelidotin, consists of human Immunoglobulin G1 (IgG1) and is site-specifically conjugated with a cleavable linker and a microtubule inhibitor (optimized auristatin) payload. Micvotabart pelidotin is designed to optimize linker stability to enable delivery of the next generation auristatin payload that can be cleaved and released in the ECM and penetrate through the tumor cell membrane to kill tumor cells directly without the need for cell surface antigen-mediated internalization of the ADC. Unlike conventional ADCs which bind to the tumor cell surface antigens, micvotabart pelidotin is designed to deliver the auristatin payload to the extracellular environment and release the free payload to kill tumor cells as well as activated fibroblasts and vascular endothelial cells that support tumor growth. We believe the free payload kills the tumor cells through a combination of bystander effect directly killing highly proliferative cells and through stimulation of the local immune cells.
Previous report
We conducted a Phase 1 dose escalation (Part 1) study, referred to as PYX-201-101 to evaluate micvotabart pelidotin monotherapy in patients with advanced solid tumors predicted to express EDB+FN. A total of 80 patients were dosed across nine solid tumor types during the PYX-201-101 (Part 1) study. In November 2024, we announced positive preliminary data from Part 1 of our Phase 1 dose escalation study of PYX-201-101 with a data cut-off date of October 4, 2024.
Previous report
The recurrent and metastatic head and neck squamous cell carcinoma (R/M HNSCC) patients were observed to show the strongest tumor regression response during this Part 1 phase of the study. Among the six efficacy evaluable patients with R/M HNSCC at the therapeutically active dose response range of 3.6 mg/kg – 5.4 mg/kg IV Q3W, the study achieved a confirmed 50% objective response rate (ORR) based on RECIST 1.1 criteria including one confirmed complete response (cCR) and two confirmed partial responses (cPRs) and yielded a disease control rate (DCR) of 100%. These six heavily pre-treated patients with R/M HNSCC had either HPV-positive (HPV+) or HPV-negative (HPV-) tumors and a median of four prior lines of systemic therapy in the advanced disease setting.
Previous report
While we observed evidence of tumor regression across all nine solid tumor types that were enrolled in the Phase 1 Part 1 dose escalation study, dose responses were most pronounced in six solid tumor types of interest, including R/M HNSCC, hormone receptor positive and human epidermal growth factor receptor 2 negative (HR+/HER2-) breast cancer, locally advanced / metastatic non-small cell lung cancer (NSCLC), ovarian cancer, sarcoma and triple negative breast cancer (TNBC), at the therapeutically active dose response range of 3.6 mg/kg – 5.4 mg/kg IV Q3W. Micvotabart pelidotin achieved a 26% ORR (n=31) in patients with these six solid tumor types dosed at 3.6 mg/kg – 5.4 mg/kg IV Q3W.
Previous report
Recent Translation Data
Previous report
In October 2025, we presented translational data at the European Society of Medical Oncology (ESMO) Congress 2025 in Berlin, Germany and at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics in Boston, Massachusetts. Data presented build on preclinical data previously presented in April 2025 at the American Association for Cancer Research (AACR) Annual Meeting in Chicago.
Previous report
The poster presentations at the ESMO and AACR-NCI-EORTC meetings provide deeper insights into the pharmacodynamic responses of tumors to micvotabart pelidotin as well as micvotabart pelidotin’s unique mechanism of action (MOA) and its potential to exert anti-tumor activity through three mechanisms: direct tumor cell killing, bystander killing and immunogenic cell death. These translational findings highlight micvotabart pelidotin’s effects on tumor microenvironment (TME) remodeling, immune activation and tumor infiltration, further reinforcing the potential benefit of micvotabart pelidotin as both monotherapy and in combination with anti-PD-1 therapy.
Previous report
Observations include changes in circulating tumor DNA (ctDNA) tumor fraction (TF) after treatment with micvotabart pelidotin to the vast majority of 37 clinical samples tested. Notably, reduction in ctDNA TF after treatment with micvotabart pelidotin, particularly in HNSCC and at the 5.4 mg/kg dose, supports a positive molecular response to micvotabart pelidotin and strengthens rationale for continued development of this tumor type and dose in the monotherapy dose expansion study. Additionally, features observed in nonclinical samples of the stromal architecture detected using digital pathology may correlate with sensitivity to micvotabart pelidotin - a finding that may be unique compared to tumor cell surface targeting ADCs, due to micvotabart pelidotin’s targeting of a non-cellular structural component of the tumor ECM.
Previous report
Additional translational data supporting micvotabart pelidotin’s MOA indicate this ADC binds very specifically to EDB+FN in the TME, an important trait for the non-cellular tumor ECM targeting MOA, locally delivering the ADC close to the malignant cells for cancer cell killing after extracellular linker cleavage. Data also indicate micvotabart pelidotin binds strongly to EDB+FN, which enables the ADC to stay anchored in the TME longer allowing more time for extracellular linker cleavage by proteases. In vitro data presented indicate micvotabart pelidotin’s linker can be cleaved extracellularly via specific cathepsins and pH conditions that exist in the TME, which are necessary conditions for the bystander effect.
Previous report
Multiple posters supported micvotabart pelidotin’s ability to induce immunogenic cell death as a mouse analog of micvotabart pelidotin stimulated immune response in tumors that had been refractory to anti-PD1 and synergistic antitumor activity when combined with anti-PD1.
Previous report
In February 2025, the U.S. Food and Drug Administration (FDA) granted Fast Track Designation to micvotabart pelidotin for the monotherapy treatment of adult patients with R/M HNSCC whose disease has progressed following treatment with platinum-based chemotherapy and an anti-PD-(L)1 antibody.
Previous report
Based on the strength of the HNSCC signal that emerged in the Part 1 dose escalation study of PYX-201-101, we have decided to prioritize our resources to focus the next stage of development on characterizing the R/M HNSCC efficacy signal.
Previous report
We are planning to hold a discussion with the FDA to align on our approach for finding the optimal monotherapy dose, as required under Project Optimus. We expect to announce next steps in the clinical development plan for MICVO for R/M HNSCC in the fourth quarter of 2025.
Previous report
We initiated Part 1 dose escalation phase of PYX-201-102 covering multiple tumor types. Currently, we are enrolling and dosing patients to clear the three doses that will be tested in combination with pembrolizumab. During Part 1 dose escalation, we anticipate testing a fixed dose of pembrolizumab in combination with 3 different doses of micvotabart pelidotin ranging from 3.6 mg/kg – 5.4 mg/kg IV Q3W. Pembrolizumab (standard dose at 200 mg IV) will be given with escalating doses of micvotabart pelidotin with a starting dose of 3.6 mg/kg IV every 3 weeks (Q3W). Upon clearance of the initial dose level of 3.6 mg/kg IV Q3W by the Dose Escalation and Steering Committee (DESC), and depending on observed safety data, we may escalate to 4.4 mg/kg IV Q3W of micvotabart pelidotin with 200 mg IV of pembrolizumab, with a potential of dosing at 5.4 mg/kg IV Q3W of micvotabart pelidotin with 200 mg IV of pembrolizumab. Dose escalation remains ongoing.
Previous report
Concurrently to the Part 1 dose escalation and assuming each dose clears the escalation step, the Phase 1/2 combination study will evaluate micvotabart pelidotin and pembrolizumab in patients with 1L and 2L+ R/M HNSCC. We expect to enroll approximately 20 patients, which will be enrolled for each dose in their respective backfill cohort upon clearance of the dose by the DESC. Pembrolizumab (standard dose at 200 mg IV) will be given with escalating doses of micvotabart pelidotin with a starting dose of 3.6 mg/kg IV every 3 weeks, followed by dose of 4.4 mg/kg IV Q3W, if DESC clears it and then a dose of 5.4 mg/kg IV Q3W, if DESC clears it. We anticipate disclosing preliminary data of R/M HNSCC patients in the fourth quarter of 2025.
Previous report
Operating Expenses
Previous report
Micvotabart pelidotin program-specific research and development costs increased by $2.0 million, primarily due to a $1.0 million increase in contract manufacturing costs for the manufacturing of micvotabart pelidotin to support our ongoing clinical trials and a $1.3 million increase in clinical trial related expenses due to two clinical trials of MICVO (monotherapy and combo-therapy), offset by a reduction in external research costs by $0.6 million.
Previous report
General and administrative expenses decreased by $0.4 million, from $6.0 million for the three months ended September 30, 2024 to $5.6 million for the three months ended September 30, 2025. The decrease was primarily related to a decrease in professional fees by $0.3 million, depreciation and corporate insurance by $0.5 million and offset by higher employee cost and stock based compensation of $0.5 million.
Previous report
Results of Operations
Previous report
Comparison of the Nine Months Ended September 30, 2025 and 2024
Previous report
The following table summarizes our results of operations for the nine months ended September 30, 2025 and 2024 (in thousands):
Previous report
Revenue
Previous report
Revenues for the nine months ended September 30, 2025 were $2.8 million, compared to $16.1 million for the nine months ended September 30, 2024. During the current period, we recognized $2.8 million of milestone revenue ($3.0 million of milestone less $0.2 million of tax in China) related to regulatory approval of Suvemcitug in China. The regulatory milestone was pursuant to an out-licensing and collaboration agreement between our subsidiary company, Apexigen and Jiangsu Simcere Pharmaceutical R&D Co., Ltd. (“Simcere”), for the development and commercialization of Suvemcitug for oncology in China.
Previous report
In March 2024, we entered into the Settlement Agreement with Novartis, pursuant to which we transferred our rights to future royalties on the net sales of Beovu® to Novartis for a one-time amount of $8.0 million. Novartis also agreed to forgo its right to reclaim royalties previously paid of $8.1 million to us and Apexigen.
Previous report
Costs and Operating Expenses
Previous report
Cost of Revenues
Previous report
We have not incurred any costs with respect to revenue during the nine months ended September 30, 2025. During the nine months ended September 30, 2024, upon execution of the Settlement Agreement with Novartis, we expensed the remaining definite-lived intangible asset of $0.5 million related to these royalty rights to cost of revenues.
Previous report
Research and development expenses increased by $7.3 million, from $44.7 million for the nine months ended September 30, 2024 to $52.0 million for the nine months ended September 30, 2025.
Previous report
Micvotabart pelidotin program-specific research and development costs increased by $9.1 million, primarily due to a $5.0 million increase in contract manufacturing costs for the manufacturing of micvotabart pelidotin to support our ongoing clinical trials and a $3.9 million increase in clinical trial related expenses due to two clinical trials of MICVO (monotherapy and combo-therapy).
Previous report
Unallocated research and development costs increased by $1.9 million from $19.6 million for the nine months ended September 30, 2024 to $21.5 million for the nine months ended September 30, 2025. This increase was primarily due to severance cost of $0.9 million and an increase in general business expense by $0.5 million.
Previous report
General and administrative expenses decreased by $3.4 million, from $20.3 million for the nine months ended September 30, 2024 to $16.9 million for the nine months ended September 30, 2025. The decrease was primarily related to a decrease in stock based compensation by $0.6 million, lower professional and consultant fees by $1.0 million and lower corporate insurance, depreciation and amortization expense by $1.1 million.
Previous report
Other income, net for the nine months ended September 30, 2025 and 2024 was $4.9 million and $7.6 million, respectively. The decrease was primarily due to a decrease in interest and investment income as compared to the previous year.
Previous report
the costs of maintaining, expanding and protecting our intellectual property portfolio;
Previous report
During the nine months ended September 30, 2024, net cash provided by financing activities was $59.3 million, which consists primarily of net proceeds of $46.9 million from the Private Placement which closed in February 2024 and net proceeds of $12.2 million from our ATM program.
Reworded paragraphs (35)
Previous wording
Pyxis Oncology is a clinical stage oncology company executing on a development strategy designed to address unmet medical needs in patients with solid tumors with an immediate focus on head and neck squamous cell carcinoma (HNSCC) tumors.
Current wording
Pyxis Oncology is a clinical-stage oncology company advancing a development strategy focused on addressing unmet medical needs in patients with solid tumors with an immediate focus on head and neck squamous cell carcinoma (HNSCC).
Previous wording
In early January 2025, we initiated the Phase 1/2 combination study with KEYTRUDA® now called PYX-201-102 and are actively recruiting patients in this study. PYX-201-102 is a Phase 1/2 open label, global, multicenter dose escalation and dose expansion study to evaluate the safety, tolerability, PK, PD and preliminary efficacy of micvotabart pelidotin in combination with pembrolizumab in patients with advanced solid tumors. Patients with histologically or cytologically confirmed advanced solid tumors, including 1L R/M HNSCC, 2L+ R/M HNSCC, cervical cancer, gastric cancer, HR+/HER2- breast cancer, sarcoma and locally advanced or metastatic TNBC, are eligible to enroll.
Current wording
In November 2024, we announced a Clinical Trial Collaboration and Supply Agreement with Merck & Co, Inc. or Merck (known as MSD outside of the United States and Canada), for a Pyxis Oncology-sponsored study of MICVO in combination with Merck’s anti-PD-1 therapy, KEYTRUDA® (pembrolizumab). In January 2025, we initiated the Phase 1/2 combination study with KEYTRUDA®, PYX-201-102, and are actively enrolling and dosing patients in this study. PYX-201-102 is a Phase 1/2 open label, global, multicenter dose escalation and dose expansion study designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and preliminary efficacy of MICVO in combination with pembrolizumab in patients with advanced solid tumors. Patients with histologically or cytologically confirmed advanced solid tumors, including 1L R/M HNSCC, 2L+ R/M HNSCC, cervical cancer, gastric cancer, HR+/HER2- breast cancer, and locally advanced or metastatic triple-negative breast cancer (TNBC), are eligible to enroll.
Previous wording
We believe the totality of our preliminary clinical, preclinical, and translational data support further development of micvotabart pelidotin in both monotherapy and in combination studies.
Current wording
We believe the totality of our preliminary clinical and preclinical data supports continued clinical development of both MICVO monotherapy expansion and combination therapy trials.
Previous wording
In early January 2025, we initiated the dose expansion phase (Part 2) of the PYX-201-101 monotherapy study with a prioritized focus to confirm the preliminary efficacy signals in R/M HNSCC seen in Part 1. We are enrolling and dosing patients for two monotherapy R/M HNSCC expansion cohorts. The Part 2 dose expansion phase includes the following two R/M HNSCC cohorts across sites in the United States (US), European Union (EU) and other countries:
Current wording
The dose expansion phase of our PYX-201-101 monotherapy study is ongoing with the objective of further evaluating the preliminary safety, efficacy and durability signals observed with MICVO in R/M HNSCC at the 5.4mg/kg IV Q3W dose. In the first quarter of 2026, we completed target enrollment of approximately 40 patients across two 2L+ R/M HNSCC cohorts in the Phase 1 monotherapy dose expansion study of MICVO and are actively treating patients in both the cohorts. The dose expansion phase includes the following R/M HNSCC cohorts across sites in the United States (US), European Union (EU) and other countries:
Previous wording
micvotabart pelidotin monotherapy for second line (2L) and third line (3L) R/M HNSCC patients who have received prior platinum-based chemotherapy and prior PD-(L)1 inhibitor therapy. We expect to enroll approximately 20 patients in this expansion cohort at the 5.4 mg/kg IV Q3W dose, a pharmacologically active dose identified during Part 1 of this trial where we have seen clinically meaningful anti-tumor activity with manageable safety. We anticipate disclosing preliminary data in the fourth quarter of 2025; and
Current wording
MICVO monotherapy for 2L and 3L R/M HNSCC patients who have received prior platinum-based chemotherapy and prior PD-(L)1 inhibitor therapy. We expect to enroll approximately 20 patients in this expansion cohort at the 5.4 mg/kg IV Q3W dose and are on track to report updated clinical data from this cohort in mid-2026; and
Previous wording
micvotabart pelidotin monotherapy for 2L and 3L R/M HNSCC patients who have received prior epidermal growth factor receptor (EGFR) directed therapy and prior PD-(L)1 inhibitor therapy. We expect to enroll approximately 20 patients in this expansion cohort also at the 5.4 mg/kg IV Q3W dose and anticipate disclosing preliminary data in the fourth quarter of 2025.
Current wording
MICVO monotherapy for 2L and 3L R/M HNSCC patients who have received prior epidermal growth factor receptor (EGFR) directed therapy and prior PD-(L)1 inhibitor therapy. We expect to enroll approximately 20 patients in this expansion cohort at the 5.4 mg/kg IV Q3W dose and are on track to report updated clinical data from this cohort in mid-2026.
Previous wording
Since our inception, we have focused substantially all of our resources on conducting research and development activities, undertaking preclinical studies and clinical trials, organizing and staffing our company, business planning, raising capital, establishing and maintaining our intellectual property portfolio and identifying potential product candidates. We do not have any products approved for sale and have not generated any revenue from product sales. We have incurred significant operating losses since our inception. We reported net losses of $61.5 million and $41.8 million for the nine months ended September 30, 2025 and 2024, respectively. As of September 30, 2025, we had an accumulated deficit of $425.1 million, net equity of $68.8 million, and cash, cash equivalents, restricted cash and short-term investments of $77.7 million. We expect to continue to incur significant expenses and operating losses for the foreseeable future. We expect that our expenses and capital expenditures will increase substantially in connection with our ongoing activities. Our operations to date have been financed primarily through sales of convertible preferred stock and sale of equity securities and additional funding may be necessary to fund future clinical and preclinical activities.
Current wording
Since our inception, we have focused substantially all of our resources on conducting research and development activities, undertaking preclinical studies and clinical trials, organizing and staffing our company, business planning, raising capital, establishing and maintaining our intellectual property portfolio and identifying potential product candidates. We do not have any products approved for sale and have not generated any revenue from product sales. We have incurred significant operating losses since our inception. We reported net losses of $23.3 million and $21.2 million for the three months ended March 31, 2026 and 2025, respectively. As of March 31, 2026, we had an accumulated deficit of $466.4 million, net equity of $31.3 million, and cash, cash equivalents and marketable debt securities of $41.0 million. We expect to continue to incur significant expenses and operating losses for the foreseeable future. We expect that our expenses and capital expenditures will increase substantially in connection with our ongoing activities. Our operations to date have been financed primarily through sales of convertible preferred stock and sale of equity securities and additional funding will be necessary to fund future clinical and preclinical activities.
Previous wording
The components of our cost of revenues are expenses directly attributable to revenues. During the three and nine months ended September 30, 2025, we have not incurred any costs with respect to revenue.
Current wording
The components of our cost of revenues are expenses directly attributable to revenues. During the three months ended March 31, 2026 and 2025, the Company has not incurred any costs with respect to revenue.
Previous wording
Research and development expenses consist of costs incurred for our research work to support clinical development, and the development of our programs. Research and development expenses are separated into program-specific costs and unallocated costs.
Current wording
Research and development expenses consist of costs incurred for our research activities, including our discovery efforts and research work to support clinical development, and the development of our programs. Research and development expenses are separated into program-specific costs and unallocated costs.
Previous wording
direct third party costs, which include expenses incurred under agreements with contract research organizations (CROs), and the cost of consultants who assist with the development of our product candidate on a program-specific basis, investigator grants, sponsored research, and any other third party expenses directly attributable to the development of the product candidate;
Current wording
direct third party costs, which include expenses incurred under agreements with contract research organizations (CROs), and the cost of consultants who assist with the development of our product candidate on a program-specific basis, investigator grants, sponsored research, and any other third party expenses directly attributable to the development of the product candidates;
Previous wording
costs of acquiring, developing, and manufacturing and testing clinical and preclinical materials, including costs incurred under agreements with contract development and manufacturing organizations (CDMOs) to the extent they can be allocated to a specific program;
Current wording
costs of acquiring, developing, manufacturing and testing clinical and preclinical materials, including costs incurred under agreements with contract development and manufacturing organizations (CDMOs) to the extent they can be allocated to a specific program;
Previous wording
costs associated with preclinical activities that are directly attributable to the development of the product candidate.
Current wording
costs associated with preclinical and clinical activities that are directly attributable to the development of the product candidates.
Previous wording
facilities and other costs, which include allocated expenses for rent and maintenance of facilities, depreciation of leasehold improvements and equipment, laboratory supplies, third party cost for research and the cost of consultants who assist with our research and development and costs related to contract manufacturing, but are not allocated to a specific program.
Current wording
facilities and other costs, which include allocated expenses for rent and maintenance of facilities, depreciation of leasehold improvements and equipment, laboratory supplies, third party cost for discovery research and the cost of consultants who assist with our research and development and costs related to contract manufacturing, but are not allocated to a specific program.
Previous wording
We expect that our research and development expenses will increase substantially in connection with our ongoing and planned preclinical and clinical development activities in the near term and in the future. The successful development of our product candidate is highly uncertain. At this time, we cannot accurately estimate or know the nature, timing and costs of the efforts that will be necessary to complete the preclinical and clinical development of our product candidate and we may never succeed in obtaining regulatory approval for our product candidate.
Current wording
We expect that our research and development expenses will increase substantially in connection with our ongoing and planned preclinical and clinical development activities related to our product candidate in the near term and in the future. The successful development of our product candidate is highly uncertain. At this time, we cannot accurately estimate or know the nature, timing and costs of the efforts that will be necessary to complete the preclinical and clinical development of our product candidate and we may never succeed in obtaining regulatory approval for our product candidate.
Previous wording
General and administrative expenses consist primarily of salaries and personnel-related costs, including stock-based compensation, and severance for our personnel in executive, legal, finance and accounting, human resources, information technology and other administrative functions. General and administrative expenses also include professional fees for auditing, tax, and legal services, as well as insurance, board of director compensation, consulting, other administrative expenses and facility costs not otherwise included in research and development expenses.
Current wording
General and administrative expenses consist primarily of salaries and personnel-related costs, including stock-based compensation, and severance for our personnel in executive, legal, finance and accounting, human resources and other administrative functions. General and administrative expenses also include professional fees for auditing, tax, and legal services, as well as insurance, board of director compensation, consulting, other administrative expenses and facility costs not otherwise included in research and development expenses.
Previous wording
Research and development expenses increased by $0.1 million, from $17.7 million for the three months ended September 30, 2024 to $17.8 million for the three months ended September 30, 2025.
Current wording
Research and development expenses increased by $2.9 million, from $17.0 million for the three months ended March 31, 2025 to $19.9 million for the three months ended March 31, 2026.
Previous wording
PYX-106 program-specific research and development costs decreased by $1.8 million as we paused the clinical development of PYX-106-101 in December 2024.
Current wording
PYX-106 program-specific research and development costs decreased by $0.5 million, reflecting lower program-related expenses following the pause in clinical development of PYX-106-101 in December 2024.
Previous wording
Other income, net for the three months ended September 30, 2025 and 2024 was $1.4 million and $2.5 million, respectively. The decrease was primarily due to a decrease in interest and investment income as compared to the previous year.
Current wording
Other income, net for the three months ended March 31, 2026 and 2025 was $1.1 million and $1.8 million, respectively. The decrease of $0.7 million was primarily due to lower interest and investment income, partially offset by higher sublease income.
Previous wording
We had cash, cash equivalents, restricted cash and short-term investments of $77.7 million as of September 30, 2025. For the three months ended September 30, 2025 and 2024, we had net losses of $22.0 million and $21.2 million, respectively. For the nine months ended September 30, 2025 and 2024, we had net losses of $61.5 million and $41.8 million, respectively. As of September 30, 2025, we had an accumulated deficit of $425.1 million.
Current wording
We had cash, cash equivalents and marketable debt securities of $41.0 million as of March 31, 2026. For the three months ended March 31, 2026 and 2025, we had net losses of $23.3 million and $21.2 million, respectively. As of March 31, 2026, we had an accumulated deficit of $466.4 million.
Previous wording
On November 1, 2022, we filed a registration statement on Form S-3 with the SEC for the issuance of common stock, preferred stock, warrants, debt securities, rights and units up to an aggregate of $250.0 million. On November 14, 2022, the registration statement was declared effective by the SEC. The registration statement includes an at-the-market, or ATM, offering program for the sale of up to $125.0 million of shares of our common stock. As of September 30, 2025, we had $106.2 million of remaining capacity available under the ATM facility.
Current wording
On November 26, 2025, we filed a registration statement on Form S-3 with the SEC for the issuance of common stock, preferred stock, warrants, debt securities, rights and units with an aggregate offering price of up to $350.0 million. On December 9, 2025, the registration statement was declared effective by the SEC. The registration statement includes an at-the-market (“ATM”) offering program for the sale of up to $150.0 million of shares of our common stock. During the three months ended March 31, 2026 and 2025, we did not sell any shares under the ATM program. As of March 31, 2026, we had $150.0 million of remaining capacity available under the ATM facility.
Previous wording
We expect our expenses to increase substantially in connection with our ongoing activities, particularly as we advance clinical trials for our product candidate in development. The timing and amount of our funding requirements will depend on many factors, including:
Current wording
We expect our expenses to increase substantially in connection with our ongoing activities, particularly as we advance further clinical trials for MICVO. The timing and amount of our funding requirements will depend on many factors, including:
Previous wording
the cost associated with monotherapy and combination therapy clinical trials for micvotabart pelidotin;
Current wording
the cost associated with monotherapy and combination therapy clinical trials for MICVO;
Previous wording
the manufacture of drug products and drug substance for micvotabart pelidotin;
Current wording
the manufacture of drug products and drug substance for MICVO;
Previous wording
the costs and timing of future commercialization activities, including product manufacturing, marketing, sales and distribution, for any of our product candidates for which we receive marketing licensure;
Current wording
the costs and timing of future commercialization activities, including product manufacturing, marketing, sales and distribution, for our product candidate for which we receive marketing licensure;
Previous wording
During the nine months ended September 30, 2024, net cash used in operating activities was $38.4 million, which consisted of our net loss of $41.8 million and a net change in our operating assets and liabilities of $5.2 million, partially offset by non-cash charges of $8.5 million. The non-cash charges of $8.5 million was primarily due to $10.2 million of stock-based compensation, $2.4 million of depreciation and amortization expense, offset by $4.6 million of accretion of discounts on marketable debt securities. The net change in our operating assets and liabilities was primarily due to a decrease in deferred revenues of $7.7 million related to the Settlement Agreement with Novartis and reductions in accrued expenses and other current liabilities by $1.0 million driven primarily by the timing of payments and services performed related to our ongoing clinical trials.
Current wording
During the three months ended March 31, 2026, net cash used in operating activities was $26.0 million, which consisted of our net loss of $23.3 million and a net change in our operating assets and liabilities of $4.4 million, partially offset by non-cash charges of $1.7 million. Non-cash charges of $1.7 million primarily consisted of $1.2 million of stock-based compensation, $0.5 million of depreciation and amortization expense, and $0.2 million of non-cash operating lease expense, partially offset by $0.2 million of accretion of discounts on marketable debt securities. The net change in operating assets and liabilities was primarily driven by a $5.9 million decrease in accounts payable, a $1.2 million increase in accrued expenses and other current liabilities, and a $0.7 million increase in prepaid expenses and other current assets, partially offset by other working capital changes, reflecting the timing of vendor payments and ongoing clinical trial activities.
Previous wording
During the nine months ended September 30, 2025, net cash used in operating activities was $53.1 million, which consisted of our net loss of $61.5 million and a net change in our operating assets and liabilities of $0.9 million, partially offset by non-cash charges of $9.3 million. The non-cash charges of $9.3 million was primarily due to $9.7 million of stock-based compensation and $1.6 million of depreciation and amortization expenses, offset by $2.6 million related to accretion of discounts on marketable debt securities. The net change in our operating assets and liabilities was primarily due to a decrease in prepaid expenses and other current assets by $1.3 million, a decrease in accrued expenses and other current liabilities by $3.3 million and an increase in accounts payable by $4.9 million primarily related to the timing of vendor payments and services performed related to our ongoing clinical trials.
Current wording
During the three months ended March 31, 2025, net cash used in operating activities was $22.5 million, which consisted of our net loss of $21.2 million and a net change in our operating assets and liabilities of $4.6 million, partially offset by non-cash charges of $3.2 million. The non-cash charges of $3.2 million was primarily due to $3.6 million of stock-based compensation, $0.6 million of depreciation and amortization expenses, offset by $1.2 million related to accretion of discounts on marketable debt securities. The net change in our operating assets and liabilities was primarily due to decrease in accounts payable by $2.0 million, accrued expenses and other current liabilities by $1.3 million and reduction in prepaid expenses by $0.9 million primarily related to the timing of vendor payments and services performed related to our ongoing clinical trials.
Previous wording
During the nine months ended September 30, 2025, net cash provided by investing activities was $42.6 million, which consisted primarily of redemption of marketable debt securities of $149.6 million, offset by purchases of marketable debt securities of $107.0 million.
Current wording
During the three months ended March 31, 2026, net cash provided by investing activities was $16.4 million, which consisted primarily of $27.4 million of maturities and redemptions of marketable debt securities, partially offset by $11.0 million of purchases of marketable debt securities.
Previous wording
During the nine months ended September 30, 2024, net cash used in investing activities was $18.5 million, which consisted primarily of purchases of marketable debt securities of $155.7 million, partially offset by redemption of marketable debt securities of $137.5 million.
Current wording
During the three months ended March 31, 2025, net cash provided by investing activities was $15.8 million, which consisted primarily of $67.2 million of maturities and redemptions of marketable debt securities, partially offset by $51.4 million of purchases of marketable debt securities.
Previous wording
During the nine months ended September 30, 2025, net cash used in financing activities was $0.1 million, which consists primarily of tax withholding payments related to the net settlement of restricted common stock.
Current wording
During the three months ended March 31, 2026, net cash used in financing activities was $0.03 million, which primarily related to tax withholding payments associated with the net settlement of restricted stock awards.
Previous wording
As of September 30, 2025, we had approximately $77.7 million in cash, cash equivalents, restricted cash and short-term investments. We believe that our cash, cash equivalents and short-term investments as of September 30, 2025, will be sufficient to fund our operations into the second half of 2026. However, we have based this estimate on assumptions that may prove to be wrong, and our operating plan may change as a result of many factors currently unknown to us. In addition, we could utilize our available capital resources sooner than we expect.
Current wording
As of March 31, 2026, we had approximately $41.0 million in cash, cash equivalents and marketable debt securities. We believe that our cash, cash equivalents and marketable debt securities as of March 31, 2026 will be sufficient to fund our operations into the fourth quarter of 2026. However, we have based this estimate on assumptions that may prove to be wrong, and our operating plan may change as a result of many factors currently unknown to us. In addition, we could utilize our available capital resources sooner than we expect.
Previous wording
The Company’s future cash flows are dependent on key variables such as its ability to secure additional sources of funding in the form of public or private financing of equity or debt or collaboration agreements or a combination of these. While we remains optimistic to obtain additional funding in the near future, the current available cash, cash equivalents and short-term investments, will not be sufficient to fund our operations over the next 12 months from the date of this Quarterly Report on Form 10-Q. This condition raises substantial doubt about our ability to continue as a going concern for one year from the date the unaudited condensed consolidated financial statements are issued.
Current wording
Our future cash flows are dependent on key variables such as our ability to secure additional sources of funding in the form of public or private financing of equity or debt or collaboration agreements or a combination of these. While we remain optimistic to obtain additional funding, the current available cash, cash equivalents and marketable debt securities, will not be sufficient to fund our operations over the next 12 months from the date of this Quarterly Report on Form 10-Q. This condition raises substantial doubt about our ability to continue as a going concern for one year from the date the unaudited condensed consolidated financial statements are issued.
Previous wording
We lease an office and laboratory space in Boston, Massachusetts with lease payments that continue through December 31, 2032, and have scheduled rent increases each year of 3%. Additionally, we sublease 17,729 square feet of office and laboratory space in the building located at 321 Harrison Avenue, Boston, Massachusetts. The remaining contractual fixed lease payments, net of sublease payments and tenant improvement allowance, over the term of the lease aggregate to $25.7 million. The operating lease obligation is discussed in Note 10. Leases to our unaudited condensed consolidated financial statements included in Part I, Item 1 of this Quarterly Report on Form 10-Q for further information.
Current wording
We lease an office and laboratory space in Boston, Massachusetts with lease payments that continue through December 31, 2032, and have scheduled rent increases each year of 3%. Additionally, we sublease 17,729 square feet of office and laboratory space in the building located at 321 Harrison Avenue, Boston, Massachusetts. The remaining contractual fixed lease payments, net of sublease payments and tenant improvement allowance, over the term of the lease aggregate to $24.7 million. The operating lease obligation is discussed in Note 10. Leases to our unaudited condensed consolidated financial statements included in Part I, Item 1 of this Quarterly Report on Form 10-Q for further information.
Previous wording
We did not have during the years presented, and we do not currently have, any off-balance sheet arrangements, as defined in the rules and regulations of the Securities and Exchange Commission.
Current wording
We did not have during the periods presented, and we do not currently have, any off-balance sheet arrangements, as defined in the rules and regulations of the Securities and Exchange Commission.
Previous wording
Our unaudited condensed consolidated financial statements are prepared in accordance with generally accepted accounting principles in the United States. The preparation of our unaudited condensed consolidated financial statements and related disclosures requires us to make estimates and judgments that affect the reported amounts of assets, liabilities, costs and expenses, and the disclosure of contingent assets and liabilities in our consolidated financial statements. We base our estimates on historical experience, known trends and events, and various other factors that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. We evaluate our estimates and assumptions on an ongoing basis. Our actual results may differ from these estimates under different assumptions or conditions.
Current wording
Our unaudited condensed consolidated financial statements are prepared in accordance with generally accepted accounting principles in the United States. The preparation of our unaudited condensed consolidated financial statements and related disclosures requires us to make estimates and judgments that affect the reported amounts of assets, liabilities, costs and expenses, and the disclosure of contingent assets and liabilities in our unaudited condensed consolidated financial statements. We base our estimates on historical experience, known trends and events, and various other factors that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. We evaluate our estimates and assumptions on an ongoing basis. Our actual results may differ from these estimates under different assumptions or conditions.
Previous wording
For information with respect to recently issued accounting standards and the impact of these standards on our consolidated financial statements, refer to Note 2. Summary of Significant Accounting Policies to our unaudited condensed consolidated financial statements included in Part I, Item 1 of this Quarterly Report on Form 10-Q.
Current wording
For information with respect to recently issued accounting standards and the impact of these standards on our unaudited condensed consolidated financial statements, refer to Note 2. Summary of Significant Accounting Policies to our unaudited condensed consolidated financial statements included in Part I, Item 1 of this Quarterly Report on Form 10-Q.
Rearranged current paragraphs (2)
Current report — wording carried from elsewhere
Arm 1: MICVO monotherapy for second line (2L) and third line (3L) R/M HNSCC patients who have received prior platinum-based chemotherapy and prior PD-(L)1 inhibitor therapy; and
Current report — wording carried from elsewhere
Arm 2: MICVO monotherapy for 2L and 3L R/M HNSCC patients who have received prior epidermal growth factor receptor (EGFR) directed therapy and prior PD-(L)1 inhibitor therapy.
Rearranged previous paragraphs (4)
Previous report — wording carried elsewhere
In November 2024, we announced a Clinical Trial Collaboration and Supply Agreement with Merck & Co, Inc. or Merck (known as MSD outside of the US and Canada), for a Pyxis Oncology-sponsored study of micvotabart pelidotin in combination with Merck’s anti-PD-(L)1 therapy, KEYTRUDA® (pembrolizumab).
Previous report — wording carried elsewhere
The following table summarizes our research and development expenses for the nine months ended September 30, 2025 and 2024 (in thousands):
Previous report — wording carried elsewhere
PYX-106 program-specific research and development costs decreased by $3.9 million, as we paused the clinical development of PYX-106-101 in December 2024.
Previous report — wording carried elsewhere
The following table summarizes our general and administrative expenses for the nine months ended September 30, 2025 and 2024 (in thousands):