Pyxis Oncology, Inc.
For the period ended Dec 31, 2025. Filed Mar 23, 2026.
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FY2025 · Filed Mar 23, 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-K
Period ended 2024-12-31; filed 2025-03-18.
0000950170-25-040771
Item 7. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-K
Period ended 2025-12-31; filed 2026-03-23.
0001193125-26-118532
Item 7. 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 131 previous paragraphs and 132 current paragraphs.
67 unchanged; 31 reworded; 32 added; 31 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 (32)
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
MICVO Monotherapy Pipeline
Current report
MICVO Phase 1 monotherapy data in 2L+ R/M HNSCC expected in mid-year 2026 will include patients dosed at 5.4 mg/kg IV Q3W with a dose cap for patients with higher body weight, as well as patients previously dosed at 5.4 mg/kg IV Q3W based on total body weight. The results are expected to include detailed analyses of the effect of the modified weight-based dosing strategy on safety and efficacy. AIBW dosing, which has demonstrated improved tolerability without apparent loss of activity in clinical studies of other antibody-drug conjugates, is being implemented in ongoing clinical studies as well.
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 expect to report updated data from the PYX-201-102 study in patients with 1L/2L+ R/M HNSCC in the second half of 2026.
Current report
The components of our cost of revenues are expenses directly attributable to earn revenues. For the years ended December 31, 2025 and 2024, cost of revenues consists of the expensing of the remaining carrying value of the definite‑lived intangible asset associated with certain royalty rights.
Current report
Revenues decreased by $2.3 million, from $16.1 million for the year ended December 31, 2024, to $13.9 million for the year ended December 31, 2025.
Current report
For the year ended December 31, 2025, we recognized revenue primarily in connection with the Simcere Agreement. Such revenue included a $2.8 million regulatory milestone earned upon approval of suvemcitug in China. In addition, we recognized consideration related to the sale of royalty rights for Enzeshu® under the amended License and Collaboration Agreement between Simcere and Apexigen, which included a one-time payment of $11.0 million and four semi-annual installment payments of $175,000 each.
Current report
Cost of revenues was $2.4 million for the year ended December 31, 2025, compared to $0.5 million for the year ended December 31, 2024. Cost of revenues in each period consisted of the write-off of the remaining carrying value of the definite-lived intangible asset associated with royalty rights sold to Simcere pursuant to the Simcere Agreement in 2025 and to Novartis pursuant to the Settlement Agreement in 2024.
Current report
PYX-106 program-specific research and development costs decreased by $4.3 million, primarily reflecting lower program-related expenses following the pause in clinical development of PYX-106-101 in December 2024.
Current report
Unallocated research and development costs increased by $5.0 million primarily due to severance cost of $0.9 million and an increase in other business expenses.
Current report
General and administrative expenses decreased by $3.2 million, from $25.4 million for the year ended December 31, 2024, to $22.2 million for the year ended December 31, 2025. This decrease was primarily attributable to a $1.9 million reduction in personnel-related expenses, including $0.6 million of lower employee-related costs and $1.3 million of lower stock-based compensation. In addition, facilities, insurance and other costs decreased by $1.0 million, and professional and consultant fees decreased by $0.3 million, primarily reflecting lower legal costs in 2025 as compared to 2024.
Current report
Other income, net for the years ended December 31, 2025 and 2024 was $6.2 million and $10.0 million, respectively. The decrease was primarily due to a decrease in interest and investment income as compared to the previous year.
Current report
Income tax expense was $1.4 million for the year ended December 31, 2025, as compared to an income tax benefit of $2.2 million for the year ended December 31, 2024. Income tax expense for 2025 was primarily related to corporate income taxes in China associated with revenue recognized from the regulatory approval milestone payment and sale of royalty rights under the Simcere Agreement. The 2024 income tax benefit resulted from the reversal of the deferred tax liability associated with the impairment of the PYX-107 IPR&D intangible asset.
Current report
Net cash provided by financing activities for the year ended December 31, 2025 was $0.6 million, which consisted primarily of $0.7 million in net proceeds from exercise of stock options and proceeds from issuance of common stock under the ESPP, partially offset by tax withholding payments related to the net settlement of restricted common stock of $0.1 million.
Current report
Outlook and Going Concern
Current report
Our 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 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
Current report
12 months from the date of this Annual Report on Form 10-K. This condition raises substantial doubt about our ability to continue as a going concern for one year from the date the audited consolidated financial statements are issued.
Removed paragraphs (31)
Previous report
Our lead product candidate, micvotabart pelidotin, 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 extra-cellular 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 extra-cellular 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 which began dosing patients in March of 2023. The study’s objective was to evaluate micvotabart pelidotin monotherapy in patients with advanced solid tumors predicted to express EDB+FN. PYX-201-101 (Part 1) is an open label, multicenter, dose escalation Phase 1 trial designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and preliminary efficacy of micvotabart pelidotin, and to identify recommended doses for further study. Patients with a variety of relapsed or refractory solid tumor types were eligible to participate, including patients with recurrent and metastatic head and neck squamous cell carcinoma (R/M HNSCC), hepatocellular carcinoma (HCC), hormone receptor positive and human epidermal growth factor receptor 2 negative (HR+/HER2-) breast cancers, locally advanced / metastatic non-small cell lung cancer (NSCLC), ovarian cancer, pancreatic ductal adenocarcinoma (PDAC), renal cell carcinoma (RCC), sarcoma, thyroid cancer and triple negative breast cancer (TNBC). A total of 80 patients were dosed during the PYX-201-101 (Part 1) study.
Previous report
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. The enrolled patients were heavily pre-treated with a median of four prior lines of systemic therapy in the advanced disease setting as many were seeking the micvotabart pelidotin experimental therapy as part of end-of-life care. Of the ten solid tumor types eligible to enroll in the study, patients across nine solid tumor types were enrolled and dosed. Tumor regression was observed in patients across all nine solid tumor types that were enrolled. The identified dose response range in the study was 3.6 mg/kg – 5.4 mg/kg IV Q3W.
Previous report
The 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, HR+/HER2- breast cancer, NSCLC, ovarian, sarcoma and TNBC, at the therapeutically active dose response range of 3.6 mg/kg – 5.4 mg/kg IV
Previous report
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
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
Fast Track Designation is an FDA program intended to facilitate and expedite the development and review of new drugs in the U.S. for the treatment of a serious or life-threatening condition. To qualify for this designation, there must be clear data demonstrating the drug has potential to address unmet medical need in the designated condition.
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 Optimusand expect the dose optimization phase to commence in 2026.
Previous report
We are planning to conduct the dose escalation phase of PYX-201-102 covering multiple tumor types with an aim to identify the Recommended Phase 2 Dose (RP2D) of micvotabart pelidotin in combination with pembrolizumab. We plan to enroll and dose 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. We aim to select a dose of micvotabart pelidotin in combination with pembrolizumab by mid-year 2025, which will guide our discussion with the FDA about potential RP2D for further combination study.
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. Patients 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 having preliminary data on at least a subset of these R/M HNSCC patients in the second half of 2025. Timing of data availability from the full recruitment and dosing of R/M HNSCC patients is dependent on the timing of activation of additional clinical trial sites and patient enrollment. Further guidance on anticipated timing of the full preliminary data readout will be provided in 2025.
Previous report
The components of our cost of revenues are expenses directly attributable to earn revenues. Pursuant to the Settlement Agreement with Novartis, we transferred our rights to future royalties on the net sales of Beovu® to Novartis and recorded the remaining definite-lived intangible asset of $0.5 million related to these royalty rights to cost of revenues. Refer to Note 5, Sale of Royalty Rights, in our Notes to Consolidated Financial Statements included in Part II, Item 8 of this Annual Report on Form 10-K for further information.
Previous report
Since our inception, we have not recognized any income tax benefits for the net losses we have incurred or for the research and development tax credits earned in each year and interim period, as we believe, based upon the weight of available evidence, that it is more likely than not that all of our net operating losses (NOLs), carryforwards and tax credit carryforwards will not be realized.
Previous report
As of December 31, 2024, our federal and state NOLs in the U.S. were $63.1 million ($300.7 million before tax) and $15.1 million ($229.6 million before tax), respectively. The federal NOL carryforwards in the U.S. can be carried forward indefinitely but may be subject to annual usage limitations to the extent certain substantial changes our ownership occur. The federal NOLs carryforward relating to tax years prior to 2017 of $5.9 million ($28.3 million before tax), acquired with Apexigen, begin to expire in 2033. The state NOL carryforwards begin expiring in 2035. In addition, as of December 31, 2024, we had $8.7 million and $3.9 million of federal and state credit carryovers related to research and development costs which begin to expire in 2030. These credit carryforwards related to research and development costs and NOLs are subject to review and possible adjustment by the relevant taxing authorities.
Previous report
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
PYX-106 program-specific research and development costs increased by $2.8 million, primarily due to a $2.0 million increase in clinical trial related expenses and $0.7 million increase in contract manufacturing costs for our Phase 1 clinical trial, PYX-106-101.
Previous report
Unallocated research and development costs decreased by $12.5 million which was primarily due to lower personnel-related expenses due to decreases in our headcount as a result of the reduction in workforce completed in the fourth quarter of 2023 and lower other unallocable costs of $3.5 million.
Previous report
General and administrative expenses decreased by $7.2 million, from $32.6 million for the year ended December 31, 2023, to $25.4 million for the year ended December 31, 2024. Personnel-related expenses decreased by $5.3 million, primarily due to a $2.4 million decrease in employee costs as a result of the reduction in workforce completed in the fourth quarter of 2023 and higher stock-based compensation of $2.6 million in the prior comparable period. The decrease in professional and consultant fees is primarily due to higher legal costs in the prior year related to the acquisition and integration of Apexigen.
Previous report
PYX-107 was acquired by us in August 2023 as part of the acquisition of Apexigen. Despite the impairment loss, the acquisition of Apexigen remains a net accretive transaction for us, whereby we issued 4.3 million common stock to acquire Apexigen in a non-cash transaction and received $9.5 million of cash since acquisition from the sale of royalty rights and royalty payments. Further, the assets acquired still have revenue generating potential through potential development milestone from out-licensing arrangement, particularly related to Simcere for which application for approval is submitted to Chinese health regulator.
Previous report
The increase in other income, net for the year ended December 31, 2024, as compared to 2023, was primarily the result of a $1.1 million increase in sublease income as rent payments on the sublease began mid-2023.
Previous report
On January 30, 2024, we completed the sale of an aggregate of 3,600,000 shares of our common stock under the ATM offering program, with an average sale price of $3.00 per share, resulting in gross proceeds of $10.8 million, before the placement agent fees.
Previous report
On February 29, 2024, we completed the private placement with certain accredited investors and issued and sold to the purchasers an aggregate of (i) 8,849,371 shares of common stock at a purchase price of $4.78 per share and (ii) Pre-Funded Warrants to purchase up to an aggregate of 1,611,215 shares of common stock at a purchase price of $4.779 per Pre-Funded Warrant. We received aggregate gross proceeds from the private placement of $50 million, before deducting placement agent fees and offering expenses.
Previous report
On March 25, 2024, we entered into the Settlement Agreement with Novartis, pursuant to which Novartis agreed to pay $8.0 million to transfer our rights to future royalties on the net sales of Beovu®, which was received on April 8, 2024.
Previous report
On August 29, 2024, we completed the sale of an aggregate of 450,000 shares of our common stock under the ATM offering program, with an average sale price of $3.66 per share, resulting in gross proceeds of $1.7 million, before the placement agent fees.
Previous report
Net cash provided by financing activities for the year ended December 31, 2024, was $59.3 million, which consisted primarily of $46.9 million net proceeds from the Private Placement which closed in February 2024 and net proceeds of $12.2 million from our ATM offering program.
Previous report
Outlook
Previous report
The Jumpstart Our Business Startups Act of 2012, or the JOBS Act, permits an “emerging growth company” to take advantage of an extended transition period to comply with new or revised accounting standards. We are an “emerging growth company,” as defined in the JOBS Act. Thus, an emerging growth company can delay the adoption of certain accounting standards until those standards would otherwise apply to private companies. We have irrevocably elected not to avail ourselves of this extended transition period, and, as a result, we will adopt new or revised accounting standards on the relevant dates on which adoption of such standards is required for other public companies.
Reworded paragraphs (31)
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
Dose-dependent responses were observed in patients who had failed to respond or had developed resistance to prior microtubule inhibitors (MTIs) such as taxanes or an ADC with Monomethyl Auristatin E (MMAE) payload. We believe this is a significant finding as response in this patient population indicates that prior treatment with MTIs may not confer resistance to micvotabart pelidotin. Additionally, we observed tumor regression in patients who had progressed on previous treatment with ADCs with Topoisomerase 1 Inhibitor payloads, which is a significant finding given the number of ADCs with Topoisomerase 1 Inhibitor payloads that are approved and in clinical development. Finally, we observed that several R/M HNSCC patients who had been previously treated with and progressed on epidermal growth factor receptor inhibitors (EGFRi) directed therapies experienced tumor regression while being treated with micvotabart pelidotin. We believe this is a very important observation as the R/M HNSCC marketplace is evolving to potentially include new EGFRi targeting agents and the ability for our product candidate to regress tumors in patients who have relapsed on EGFRi therapies will enable us to compete in both the current and emerging standard of care landscape. We believe the totality of our preliminary data supports further development of both micvotabart pelidotin monotherapy expansion and combination therapy trials.
Current wording
We believe the totality of our preliminary data supports continued clinical development of both MICVO monotherapy expansion and combination therapy trials.
Previous wording
The following table summarizes our clinical pipeline reflecting this prioritized focus:
Current wording
The following table summarizes our clinical pipeline:
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 actively recruiting 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 dose. We completed target enrollment of approximately 40 patients in the Phase 1 monotherapy dose expansion study of MICVO in 2L+ R/M HNSCC in the first quarter of 2026 and are actively treating patients in two monotherapy R/M HNSCC cohorts at the 5.4 mg/kg IV Q3W dose. 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 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 having preliminary data in the second half 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 anticipate reporting 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 patients in this expansion cohort also at the 5.4 mg/kg IV Q3W dose and anticipate having preliminary data in the first half of 2026.
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 anticipate reporting 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 $77.3 million and $73.8 million for the years ended December 31, 2024 and 2023, respectively. As of December 31, 2024, we had an accumulated deficit of $363.6 million, net equity of $120.8 million, and cash, cash equivalents and short-term investments of $126.9 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 $79.6 million and $77.3 million for the years ended December 31, 2025 and 2024, respectively. As of December 31, 2025, we had an accumulated deficit of $443.2 million, net equity of $53.4 million, and cash, cash equivalents and marketable debt securities of $66.9 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
To date, we have not generated any revenues from product sales and do not expect to generate any revenues from product sales in the foreseeable future. We record revenues from research and development agreements, including amounts related to upfront receipt for license fees, royalties, milestones and other contingent receipts and fees for research and development services.
Current wording
To date, we have not generated any revenues from product sales and do not expect to generate any revenues from product sales in the foreseeable future. We record revenues from research and development agreements, including amounts related to upfront receipt for license fees, royalties, sale of royalty rights, milestones and other contingent receipts and fees for research and development services.
Previous wording
General and administrative expenses consist primarily of salaries and personnel-related costs, including stock-based compensation 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.
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
Other income, net primarily consists of interest earned on our invested cash and cash equivalent balances, accretion of discounts associated with our marketable debt securities and sublease income under our sublease.
Current wording
Other income, net primarily consists of interest earned on our invested cash and cash equivalent balances, accretion of discounts associated with our marketable debt securities and sublease rental income under our sublease.
Previous wording
Revenues for the year ended December 31, 2024, were $16.1 million, compared to $0 for the year ended December 31, 2023. 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. Both of these amounts were recognized as revenues upon execution of the Settlement Agreement during the year ended December 31, 2024.
Current wording
For the year ended December 31, 2024, revenues consisted of amounts recognized for the Settlement Agreement with Novartis. Pursuant to the Settlement Agreement, we transferred our rights to future royalties on net sales of Beovu® to Novartis in exchange for a one-time payment of $8.0 million. In addition, Novartis agreed to waive its right to recoup $8.1 million of royalties previously paid to us and Apexigen.
Previous wording
Research and development expenses increased by $9.1 million, from $49.6 million for the year ended December 31, 2023, to $58.7 million for the year ended December 31, 2024.
Current wording
Research and development expenses increased by $15.0 million, from $58.7 million for the year ended December 31, 2024, to $73.7 million for the year ended December 31, 2025.
Previous wording
Micvotabart pelidotin program-specific research and development costs increased by $18.3 million, primarily due to a $10.2 million increase in contract manufacturing costs due to the timing of manufacturing runs for micvotabart pelidotin, a $4.8 million increase in clinical trial related expenses due to a higher number of patients dosed and a $2.3 million increase in preclinical and translation work to support micvotabart pelidotin clinical development work.
Current wording
MICVO program-specific research and development costs increased by $14.1 million, primarily reflecting a $6.1 million increase in contract manufacturing costs due to the timing of MICVO manufacturing runs and a $7.5 million increase in clinical trial-related expenses associated with the MICVO monotherapy and combination therapy trials, as a result of a higher number of patients dosed and site activations.
Previous wording
In December 2024, we announced our strategic realignment plan to prioritize resources towards clinical development of our lead asset micvotabart pelidotin and we continue to defer further clinical development of PYX-107. Given the uncertain timing of future clinical development of PYX-107, our decline in market capitalization in the fourth quarter of 2024 and the current biotech environment, in which access to additional capital is limited, we concluded that the in-process research and development intangible asset related to PYX-107 was fully impaired during the fourth quarter of 2024. We recognized a non-cash impairment loss of $21.0 million during the year ended December 31, 2024. No impairment loss was recorded during the year ended December 31, 2023. We continue to believe in the scientific and clinical potential of PYX-107 and the opportunity to advance clinical development of PYX-107 may be re-evaluated upon new data availability from any ongoing investigator initiation trials (ISTs) in PYX-107 in the context of any future portfolio evaluations that we may conduct.
Current wording
In December 2024, we announced a strategic realignment plan to prioritize resources toward clinical development of MICVO and continue to defer further clinical development of PYX-107. As a result of the uncertain timing of the future clinical development of PYX-107, we recognized an impairment loss of $21.0 million during the year ended December 31, 2024. No impairment loss was recorded during the year ended December 31, 2025.
Previous wording
We had cash, cash equivalents and short-term investments of $126.9 million as of December 31, 2024. For the years ended December 31, 2024 and 2023, we had net losses of $77.3 million and $73.8 million, respectively. As of December 31, 2024, we had an accumulated deficit of $363.6 million
Current wording
We had cash, cash equivalents and marketable debt securities of $66.9 million as of December 31, 2025. For the years ended December 31, 2025 and 2024, we had net losses of $79.6 million and $77.3 million, respectively. As of December 31, 2025, we had an accumulated deficit of $443.2 million.
Previous wording
On November 1, 2022, we filed a registration statement on Form S-3 with the U.S. Securities and Exchange Commission (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 (ATM) offering program for the sale of up to $125.0 million shares of our common stock.
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 up to an aggregate of $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 year ended December 31, 2025, we did not sell any shares under the ATM program. As of December 31, 2025, 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 further clinical trials for micvotabart pelidotin. 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
If we raise additional funds through collaborations, strategic alliances or marketing, distribution or licensing arrangements with third parties, we may have to relinquish valuable rights to our technologies, future revenue streams, research programs or product candidates, or grant licenses on terms that may not be favorable to us. If we are unable to raise additional funds through equity or debt financings when needed, we may be required to delay, limit, reduce or terminate our product development or future commercialization efforts or grant rights to develop and market product candidates that we would otherwise prefer to develop and market ourselves.
Current wording
If we raise additional funds through collaborations, strategic alliances or marketing, distribution or licensing arrangements with third parties, we may have to relinquish valuable rights to our technologies, future revenue streams, research programs or product candidate, or grant licenses on terms that may not be favorable to us. If we are unable to raise additional funds through equity or debt financings when needed, we may be required to delay, limit, reduce or terminate our product development or future commercialization efforts or grant rights to develop and market product candidate that we would otherwise prefer to develop and market ourselves.
Previous wording
Net cash used in operating activities for the year ended December 31, 2023, was $70.7 million, which consisted of our net loss of $73.8 million and a net change in our operating assets and liabilities of $11.7 million, offset by non-cash charges of $14.7 million. The non-cash charges were primarily due to $16.9 million in stock-based compensation and $1.9 million of depreciation and amortization expense, partially offset by $4.8 million of accretion of discounts on marketable debt securities. The net change in our operating assets and liabilities was primarily due to a decrease of $14.1 million in accrued expenses and other current liabilities, which primarily relates to a one-time payment of $8.0 million made to Pfizer in January 2023 pursuant to the Pfizer A&R License Agreement, and reduction in accounts payable by $3.5 million resulting from the timing of payments to our service providers. These decreases were partially offset by a $2.5 million increase to prepaid expenses and other current assets and a $2.4 million increase to operating lease liabilities driven by tenant improvement allowance deposits.
Current wording
Net cash used in operating activities for the year ended December 31, 2025 was $63.5 million, which consisted of our net loss of $79.6 million, a net increase in our operating assets and liabilities of $1.9 million partially offset by non-cash charges of $14.2 million. The non-cash charges were primarily due to $11.8 million in stock-based compensation, $4.5 million of depreciation and amortization expense and $0.8 million of operating lease expense, offset by $3.0 million of accretion of discounts on marketable debt securities. The net change in our operating assets and liabilities was primarily due to a $6.0 million increase in accounts payable related to timing of vendor payment, a $0.3 million decrease in prepaid expenses and other current assets, a reduction of $2.8 million in accrued expenses and other current liabilities and a decrease in operating lease liabilities of $1.5 million.
Previous wording
Net cash used in operating activities for the year ended December 31, 2024, was $57.7 million, which consisted of our net loss of $77.3 million and a net change in our operating assets and liabilities of $11.8 million, offset by non-cash charges of $31.5 million. The non-cash charges were primarily due to $21.0 of impairment, $12.9 million in stock-based compensation and $3.0 million of depreciation and amortization expense, offset by $6.1 million of accretion of discounts on marketable debt securities. The net change in our operating assets and liabilities was primarily due to a decrease of $7.7 million in deferred revenue related to the Settlement Agreement with Novartis, a reduction of $1.7 million in accrued expenses and other current liabilities and operating lease payments of $1.2 million. These decreases were partially offset by a $1.2 million increase in accounts payable related to timing of vendor payments.
Current wording
Net cash used in operating activities for the year ended December 31, 2024 was $57.7 million, which consisted of our net loss of $77.3 million and a net change in our operating assets and liabilities of $11.8 million, offset by non-cash charges of $31.5 million. The non-cash charges were primarily due to a $21.0 impairment of an intangible asset, $12.9 million in stock-based compensation and $3.0 million of depreciation and amortization expense, offset by $6.1 million of accretion of discounts on marketable debt securities. The net change in our operating assets and liabilities was primarily due to reversal of $7.7 million in deferred revenue related to the Settlement Agreement with Novartis, a reduction of $1.7 million in accrued expenses and other current liabilities and a decrease in operating lease payments of $1.2 million. These decreases were partially offset by a $1.2 million increase in accounts payable related to timing of vendor payments.
Previous wording
Net cash used in investing activities for the year ended December 31, 2023, was $104.9 million, which consisted primarily of purchases of marketable debt securities of $196.8 million and leasehold improvements and purchases of property and equipment for our headquarters of $7.0 million, partially offset by redemption of marketable debt securities of $92.0 million and cash acquired as part of the acquisition of Apexigen of $6.7 million.
Current wording
Net cash provided by investing activities for the year ended December 31, 2025 was $58.9 million, which consisted of the redemption of marketable debt securities of $165.9 million, offset by purchases of marketable debt securities of $107.0 million.
Previous wording
Net cash provided by investing activities for the year ended December 31, 2024, was $8.2 million, which consisted primarily of redemption of marketable debt securities of $168.5 million, partially offset by purchases of marketable debt securities of $160.1 million.
Current wording
Net cash used in investing activities for the year ended December 31, 2024 was $8.2 million, which consisted of the redemption of marketable debt securities of $168.5 million, offset by purchases of marketable debt securities of $160.1 million.
Previous wording
Net cash provided by financing activities for the year ended December 31, 2023, was $5.9 million, which consisted primarily of net proceeds from our ATM offering program.
Current wording
Net cash provided by financing activities for the year ended December 31, 2024 was $59.3 million, which consisted primarily of net proceeds from the issuance of common stock and pre-funded warrants in private placements and our ATM offering program.
Previous wording
As of December 31, 2024, we had approximately $126.9 million in cash, cash equivalents and short-term investments. We believe that our cash and cash equivalents as of December 31, 2024, 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 December 31, 2025, we had approximately $66.9 million in cash, cash equivalents and marketable debt securities. We believe that our cash, cash equivalents and marketable debt securities as of December 31, 2025 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
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 $26.7 million. The operating lease obligation is discussed in Note 13, Operating Leases, in our Notes to Consolidated Financial Statements included in Part II, Item 8 of this Annual Report on Form 10-K.
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 $25.1 million. The operating lease obligation is discussed in Note 12, Operating Leases, in our Notes to Consolidated Financial Statements included in Part II, Item 8 of this Annual Report on Form 10-K.
Previous wording
As part of the process of preparing our consolidated financial statements, we are required to estimate our accrued research and development expenses. This process involves estimating the level of service performed and the associated cost incurred for the service when we have not yet been invoiced or otherwise notified of actual costs. The majority of our service providers invoice us in arrears for services performed, on a pre-determined schedule or when contractual milestones are met; however, some require advance payments. We make estimates of our accrued expenses as of each balance sheet date in the consolidated financial statements based on facts and circumstances known to us at that time. At each period end, we corroborate the accuracy of these estimates with the service providers and make adjustments, if necessary. Examples of estimated accrued research and development expenses include those related to fees paid to:
Current wording
As part of the process of preparing our consolidated financial statements, we are required to estimate our accrued research and development expenses. Research and development costs are expensed as incurred and consist primarily of license fees to acquire intellectual property that do not meet the definition of intangible assets and costs incurred in performing research and development activities, including personnel-related expenses such as salaries, stock-based compensation and benefits, facilities costs, depreciation, as well as external costs from third parties who conduct research and development activities (including manufacturing) on our behalf. This process involves estimating the level of service performed and the associated cost incurred for the service when we have not yet been invoiced or otherwise notified of actual costs. The majority of our service providers invoice us in arrears for services performed, on a pre-determined schedule or when contractual milestones are met; however, some require advance payments. We make estimates of our accrued expenses as of each balance sheet date in the consolidated financial statements based on facts and circumstances known to us at that time. Payments under some of these contracts depend on preclinical and/or clinical trial milestones. At each period end, we corroborate the accuracy of these estimates with the service providers and make adjustments, if necessary. Examples of estimated accrued research and development expenses include those related to fees paid to:
Previous wording
We record the expense and accrual related to contract research and manufacturing based on our estimates of the services received and efforts expended considering a number of factors, including our knowledge of the progress towards completion of the research, development and manufacturing activities; invoicing to date under contracts; communication from the CROs, CDMOs and other companies of any actual costs incurred during the period that have not yet been invoiced; and the costs included in the contracts and purchase orders. In accruing service fees, we estimate the period over which services will be performed and the level of effort to be expended in each period. If the actual timing of the performance of services or the level of effort varies from the estimate, we adjust the accrual or the amount of prepaid expense accordingly. There have not been any material adjustments to our prior estimates of accrued research and development expenses.
Current wording
We record the expense and accrual related to contract research and manufacturing based on our estimates of the services received and efforts expended pursuant to the terms of the contractual arrangements considering a number of factors, including our knowledge of the progress towards completion of the research, development and manufacturing activities; invoicing to date under contracts; communication from the CROs, CDMOs and other companies of any actual costs incurred during the period that have not yet been invoiced; and the costs included in the contracts and purchase orders. There may be instances in which payments made to our vendors exceed the level of services provided and result in a prepayment of expenses. In accruing service fees, we estimate the period over which services will be performed and the level of effort to be expended in each period. If the actual timing of the performance of services or the level of effort varies from the estimate, we adjust the accrual or the amount of prepaid expense accordingly. There have not been any material adjustments to our prior estimates of accrued research and development expenses.
Previous wording
We are also a “smaller reporting company,” meaning that the market value of our shares held by non-affiliates is less than $700 million and our annual revenue was less than $100 million during the most recently completed fiscal year. We may rely on exemptions from certain disclosure requirements that are available to smaller reporting companies. Specifically, as a smaller reporting company, we may choose to present only the two most recent fiscal years of audited financial statements in our Annual Report on Form 10-K and have reduced disclosure obligations regarding executive compensation, and, similar to emerging growth companies, if we are a smaller reporting company with less than $100 million in annual revenue, we are not required to obtain an attestation report on internal control over financial reporting issued by our independent registered public accounting firm.
Current wording
We are an “emerging growth company,” as defined in the Jumpstart Our Business Startups Act of 2012, or the JOBS Act. We are also a “smaller reporting company,” meaning that the market value of our shares held by non-affiliates is less than $700 million and our annual revenues were less than $100 million during the most recently completed fiscal year. We may rely on exemptions from certain disclosure requirements that are available to smaller reporting companies. Specifically, as a smaller reporting company, we may choose to present only the two most recent fiscal years of audited financial statements in our Annual Report on Form 10-K and have reduced disclosure obligations regarding executive compensation, and, similar to emerging growth companies, if we are a smaller reporting company with less than $100 million in annual revenues, we would not be required to obtain an attestation report on internal control over financial reporting issued by our independent registered public accounting firm.
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 (2)
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
As of December 31, 2024, we had $106.2 million of remaining capacity available under the ATM offering program.