Pyxis Oncology, Inc.
For the period ended Sep 30, 2026. Filed Nov 5, 2026.
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A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Sep 30, 2026 · Filed Nov 5, 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 2026-06-30; filed 2026-08-13.
0001193125-26-347913
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2026-09-30; filed 2026-11-05.
0001193125-26-448612
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 135 previous paragraphs and 131 current paragraphs.
72 unchanged; 38 reworded; 21 added; 22 removed; 3 previous and 0 current paragraphs rearranged.
Tables are not compared: 7 previous and 7 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
Added paragraphs (21)
Current report
Updated Phase 1 Monotherapy Data in 2L+ R/M HNSCC (September 2026)
Current report
In September 2026, we reported positive updated data from PYX-201-101, based on an August 18, 2026 data cut-off, for the 35 patients with 2L+ R/M HNSCC who had been treated at 5.4 mg/kg IV Q3W with a dose equivalent to or below the dose cap (the dose cap population), of whom 33 were efficacy evaluable. The dose cap population included heavily pre-treated patients from both dose expansion cohorts: patients had received a median of three prior lines of systemic therapy (range one to five), including a median of two prior lines in the recurrent or metastatic setting; all patients had received prior platinum-based therapy and prior anti-PD-(L)1 therapy; 71% had received a prior taxane; and 57% had received a prior EGFR inhibitor, including five patients previously treated with the novel EGFR-targeting agents petosemtamab or ficerafusp alfa. Approximately half of the patients (51%) had HPV-positive oropharyngeal squamous cell carcinoma and the remainder (49%) had HPV-unrelated disease. Patient demographics and the prior treatment characteristics of treated patients are illustrated in Table 1 below.
Current report
Demographics
Current report
Efficacy Data
Current report
Among the 33 efficacy evaluable patients, the confirmed ORR per RECIST v1.1 was 36% (12/33) and the DCR was 94% (31/33). Responses were rapid and deep: 75% of responders achieved a response by the first scan at six weeks, and 83% of responders achieved a greater than 50% reduction in tumor burden from baseline. Median progression-free survival (PFS) was 6.2 months (95% confidence interval (CI): 4.8 to 8.8 months), the 12-month overall survival (OS) probability was 79% (95% CI: 58.1% to 90.3%), and median OS had not been reached as of the data cut-off. A summary of the efficacy data is provided in Table 2 below.
Current report
Clinical activity was observed across key patient subgroups, with a confirmed ORR of 35% in patients with HPV-positive oropharyngeal disease (n=17) and 38% in patients with HPV-unrelated disease (n=16); 28% in patients who had received a prior EGFR inhibitor (n=18), including 40% in the subset previously treated with a novel EGFR-targeting agent (n=5), and 47% in patients who had not received a prior EGFR inhibitor (n=15); and 35% in patients who had received a prior taxane (n=23) and 40% in those who had not (n=10). Efficacy data by patient subgroup are provided in Table 3 below.
Current report
Safety Data
Current report
No new safety signals were observed, and the tolerability profile was consistent with that of other ADCs with auristatin payloads and was generally manageable. The median duration of treatment was 120 days (range 21 to 470 days). TRAEs of any grade were reported in 91% (32/35) of patients, Grade ≥3 TRAEs in 54% (19/35), non-hematologic CTCAE Grade ≥3 TRAEs in 43% (15/35) and serious TRAEs in 14% (5/35). TRAEs led to dose reduction in 40% (14/35) of patients and to treatment discontinuation in 14% (5/35) of patients (three due to peripheral neuropathy, one due to an ocular event and one due to muscle weakness), with discontinuations occurring at a median of 162 days after the start of treatment (min – max, 104-212). There were no treatment-related deaths. ADC payload TRAEs of interest were predominantly Grade 1/2 and Grade 3 events, respectively: cutaneous 49% (17/35) and 6% (2/35), peripheral neuropathy 40% (14/35) and 17% (6/35), ocular events in 29% (10/35) and 6% (2/35) and pneumonitis in 11% (4/35) and 0%. Adverse events of interest, including peripheral neuropathy, generally occurred after patients had experienced evidence of benefit and after prolonged duration of treatment, with a median time to onset of 82 days (range 3 to 157) for Grade 1 or 2 peripheral neuropathy and 166 days (range 85 to 197) for Grade 3 peripheral neuropathy. The data indicated that dose capping reduced the frequency and severity of adverse events in high body weight patients, which we believe validates our dose capping strategy of maintaining clinical activity while mitigating the risk of safety events. Table 4 below summarizes key TRAEs observed as of the August 18, 2026 data cut-off date.
Current report
MICVO Monotherapy Next Stage of Development
Current report
In November 2026, data from our Phase 1 monotherapy study in previously treated R/M HNSCC are expected to be presented in a late-breaking oral presentation at the 38th EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics, where we also expect to present preclinical findings in two poster presentations further characterizing MICVO’s extracellular mechanism of action and evaluating MICVO in combination with EGFR-targeted therapy.
Current report
We have aligned with feedback from the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) on the design of Headliner SM, our planned global pivotal Phase 3 monotherapy trial of MICVO in patients with 2L+ R/M HNSCC whose disease has progressed following treatment with both platinum-based chemotherapy and an anti-PD-1 therapy. The randomized, open-label, two-arm trial is expected to enroll approximately 500 patients, randomized 1:1 to MICVO or investigator’s choice of cetuximab, docetaxel or methotrexate, with co-primary endpoints of overall response rate and overall survival. We are advancing the clinical development of MICVO through Project Optimus, the FDA’s initiative focused on dose optimization and dose selection in oncology drug development, and in February 2025 the FDA granted Fast Track Designation for MICVO for the treatment of adult patients with R/M HNSCC whose disease has progressed following treatment with platinum-based chemotherapy and an anti-PD-(L)1 therapy. We expect to receive FDA feedback on dose selection from our End-of-Phase 2 meeting in the first quarter of 2027, and plan to initiate our global pivotal Phase 3 trial, Headliner SM, in mid-2027 following alignment with the FDA on dose selection.
Current report
Operating Expenses
Current report
Unallocated research and development costs remained flat year over year.
Current report
Comparison of the Nine Months Ended September 30, 2026 and 2025
Current report
The following table summarizes our results of operations for the nine months ended September 30, 2026 and 2025 (in thousands):
Current report
Research and development expenses increased by $0.6 million, from $52.0 million for the nine months ended September 30, 2025 to $52.6 million for the nine months ended September 30, 2026.
Current report
On October 1, 2026, we completed an underwritten public offering (the “Public Offering”) of (i) 36,047,919 shares of our common stock and (ii) pre-funded warrants to purchase 1,883,121 shares of our common stock, in each case together with accompanying common warrants to purchase an aggregate of 49,310,352 shares of common stock (the “October 2026 Warrants”). The combined public offering price was $2.90 per share of common stock and accompanying October 2026 Warrants and $2.899 per pre-funded warrant and accompanying October 2026 Warrants. The pre-funded warrants have an exercise price of $0.001 per share. The October 2026 Warrants have an exercise price of $3.50 per share, will become exercisable only following stockholder approval of, and the effectiveness of, an amendment to our certificate of incorporation to increase the number of authorized shares of common stock, and will expire on the earlier of (i) the fifth anniversary of the effective date of such amendment and (ii) the 30th calendar day following the later of such effective date and the public release of overall survival data from our MICVO Phase 1 monotherapy study in second line and beyond recurrent / metastatic HNSCC. We do not currently have sufficient authorized shares of common stock to permit the exercise of the October 2026 Warrants. On October 21, 2026, we filed a definitive proxy statement for a special meeting of stockholders to be held on November 13, 2026, at which stockholders will vote on an amendment to increase the number of authorized shares of common stock from 190,000,000 to 380,000,000.
Current report
We received gross proceeds of approximately $110.0 million, before deducting underwriting discounts and commissions and offering expenses. These amounts exclude any proceeds we may receive from the October 2026 Warrants or the pre-funded warrants. We may receive up to approximately $172.6 million of additional gross proceeds if all of the October 2026 Warrants and pre-funded warrants are exercised in full for cash. See Note 14, Subsequent Events, to our unaudited condensed consolidated financial statements included in Part I, Item 1 of this Quarterly Report on Form 10-Q.
Current report
the cost associated with our planned Phase 3 Headliner SM trial;
Current report
Outlook
Current report
If the October 2026 Warrants are not exercised, these funds will not be sufficient to fully fund our planned global pivotal Phase 3 Headliner SM trial and we will need to raise additional capital to fund our operations beyond the first half of 2028 and to complete the development of MICVO, which we may seek through public or private equity or debt financings, collaboration agreements or a combination of these.
Removed paragraphs (22)
Previous 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.
Previous report
Recent Preclinical Data
Previous 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:
Previous report
maMICVO produced dose-dependent inhibition of EDB+FN-expressing MOC2 tumor outgrowth, with 6 mg/kg showing the strongest tumor growth inhibition.
Previous 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.
Previous 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.
Previous report
We believe the totality of our preliminary clinical and preclinical data supports MICVO’s broad potential to address a significant unmet need for patients with R/M HNSCC regardless of HPV status or prior therapy and continued clinical development of both MICVO monotherapy expansion and combination therapy trials.
Previous report
MICVO Monotherapy Pipeline
Previous report
The dose expansion phase of our Phase 1, 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, approximately 20 in each of two 2L+ R/M HNSCC cohorts, and we are actively treating patients in both 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 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, which continues to inform our development strategy for MICVO in this setting.
Previous report
Costs and Operating Expenses
Previous report
Cost of Revenues
Previous report
The components of our cost of revenues are expenses directly attributable to revenues. During the three and six months ended June 30, 2026 and 2025, the Company has not incurred any costs with respect to revenue.
Previous report
Unallocated research and development costs decreased by $0.7 million, primarily due to lower research and development support costs of $0.4 million, decreased facilities and depreciation costs of $0.3 million, and decreased recruitment costs of $0.2 million, offset by an increase of $0.4 million in compensation costs.
Previous report
Results of Operations
Previous report
Comparison of the six months ended June 30, 2026 and 2025
Previous report
The following table summarizes our results of operations for the six months ended June 30, 2026 and 2025 (in thousands):
Previous report
Milestone Revenue
Previous report
Research and development expenses increased by $1.9 million, from $34.2 million for the six months ended June 30, 2025 to $36.0 million for the six months ended June 30, 2026.
Previous report
October 1, 2026, and the Common Warrants will expire on July 2, 2029. We received upfront gross proceeds from the issuance of common stock under the Private Placement of approximately $50 million (of which $10.0 million was received on June 30, 2026), before deducting placement agent fees and offering expenses.
Previous report
Outlook and Going Concern
Previous report
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, even after giving effect to the proceeds from the Private Placement, 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.
Reworded paragraphs (38)
Previous wording
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 wording
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 first-line/second-line and beyond (1L/2L+) R/M HNSCC and other solid tumors. In September 2026, we reported positive updated data from our Phase 1 monotherapy study in second-line and beyond (2L+) R/M HNSCC, which we believe support the advancement of MICVO into a pivotal program, and we plan to initiate Headliner SM, our global pivotal Phase 3 monotherapy trial in 2L+ R/M HNSCC, in mid-2027.
Previous wording
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 wording
Our ongoing global Phase 1 monotherapy study, referred to as PYX-201-101, is a multi-part study. Part 1 was a dose escalation study evaluating MICVO monotherapy in patients with advanced solid tumors known to express EDB+FN, and Part 2 is a dose expansion study which includes 2L+ R/M HNSCC. In November 2024, we reported positive preliminary results from the Part 1 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 these observations, 5.4 mg/kg IV Q3W was selected for dose expansion as the dose presenting the optimal benefit-risk profile within the efficacious dose range, and subsequent translational data showing a reduction in circulating tumor DNA (ctDNA) tumor fraction (TF) after treatment with MICVO, particularly at the 5.4 mg/kg dose, further supported this dose selection.
Previous wording
PYX-201-101 Phase 1 (Part 2) Monotherapy Dose Expansion in R/M HNSCC
Current wording
PYX-201-101 Phase 1 (Part 2) Monotherapy Dose Expansion in 2L+ R/M HNSCC
Previous wording
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 implemented a dose cap for higher body weight patients in December 2025 and continue to evaluate dosing strategies to optimize MICVO’s benefit-risk profile. The Fall 2026 clinical update is expected to include analyses of the impact of dose capping on safety, tolerability, efficacy and initial durability.
Current wording
In December 2025, we reported positive preliminary data, based on a November 3, 2025 data cut-off, for the 18 R/M HNSCC patients treated at 5.4 mg/kg based on total body weight (TBW) in Part 1 and Part 2, of whom 13 were efficacy evaluable. Among the 13 efficacy evaluable patients, the confirmed ORR was 46% (6/13) per RECIST v1.1, including one confirmed CR, and the DCR was 92% (12/13); confirmed responses were observed in both dose expansion cohorts and regardless of human papillomavirus (HPV) status. MICVO was generally well tolerated, with Grade ≥3 treatment-related adverse events (TRAEs) reported in 56% (10/18) of patients, TRAEs leading to treatment discontinuation in 28% (5/18) of patients, and no Grade 4 ADC payload TRAEs of interest or Grade 5 events. All five patients who discontinued treatment due to TRAEs had high body weight (defined as at least 10% above adjusted ideal body weight, or AIBW), consistent with the association of patient body weight, systemic drug exposure and tolerability that has been observed with several approved ADCs and addressed through modified weight-based dosing such as dose capping or AIBW dosing. In December 2025, we implemented a dose cap.
Previous 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.
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®(pembrolizumab), 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 expect to report updated clinical data from both cohorts in Fall 2026. We believe this timeline allows for additional follow-up of 2L+ R/M HNSCC patients treated with MICVO at 5.4 mg/kg IV Q3W with a dose equivalent to or below a dose cap and will support detailed analyses of the impact of dose capping on safety, tolerability, efficacy and initial durability.
Current wording
In September 2026, we reported updated clinical data from both cohorts for patients treated with MICVO at 5.4 mg/kg IV Q3W with a dose equivalent to or below a dose cap (see “Updated Phase 1 Monotherapy Data in 2L+ R/M HNSCC (September 2026)” above). We expect to report updated OS data from this study in the first half of 2027.
Previous wording
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 wording
Our Phase 1/2 combination study with KEYTRUDA®(pembrolizumab) (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.
Previous wording
We anticipate reporting updated clinical data in the fourth quarter 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 wording
We plan to provide a corporate update in December 2026 that we expect will outline a comprehensive development strategy for MICVO in R/M HNSCC, including how emerging combination data inform potential opportunities across treatment settings, and will include updated efficacy and safety data from the ongoing PYX-201-102 Phase 1/2 dose escalation study evaluating MICVO in combination with KEYTRUDA® (pembrolizumab) across multiple doses in 1L R/M HNSCC. The update is expected to include data from a total of at least 20 patients with 1L R/M HNSCC treated with MICVO at the 3.6 mg/kg and 4.4 mg/kg dose levels in combination with a fixed dose of 200 mg of pembrolizumab. We expect to report additional data evaluating initial durability and supporting selection of the recommended Phase 3 dose for the 1L combination in the second half of 2027.
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 $48.6 million and $39.5 million for the six months ended June 30, 2026 and 2025, respectively. As of June 30, 2026, we had an accumulated deficit of $491.8 million, net equity of $11.4 million, and cash, cash equivalents and marketable debt securities of $33.0 million. Subsequent to June 30, 2026, we completed a private placement financing that generated gross proceeds of approximately $50.0 million (of which $10.0 million was received on June 30, 2026), before deducting placement agent fees and offering expenses, and expect the upfront proceeds from the financing to fund our operating expenses and capital expenditure requirements into the second quarter of 2027. 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 sale of equity securities and additional funding will 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 $68.6 million and $61.5 million for the nine months ended September 30, 2026 and 2025, respectively. As of September 30, 2026, we had an accumulated deficit of $511.8 million, net equity of $41.3 million, and cash, cash equivalents and marketable debt securities of $55.6 million. On October 1, 2026, we closed an underwritten public offering of common stock, pre-funded warrants and accompanying common warrants and received upfront gross proceeds of approximately $110.0 million, before deducting underwriting discounts and commissions and other offering expenses. We expect that our existing cash, cash equivalents and marketable debt securities, together with the net upfront proceeds from the public offering, will be sufficient to fund our operating expenses and capital expenditure requirements into the first half of 2028. We expect to continue to incur significant expenses and operating losses for the foreseeable future. We expect that our operating expenses and capital expenditures will increase substantially in connection with our ongoing activities. Our operations to date have been financed primarily through the sale of equity securities and additional funding will be necessary to fund future clinical and preclinical activities.
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 income under our former sublease, which ended in May 2026.
Previous wording
Research and development expenses decreased by $1.1 million, from $17.1 million for the three months ended June 30, 2025 to $16.1 million for the three months ended June 30, 2026.
Current wording
Research and development expenses decreased by $1.3 million, from $17.8 million for the three months ended September 30, 2025 to $16.6 million for the three months ended September 30, 2026.
Previous wording
MICVO program-specific research and development costs decreased by $0.1 million, primarily due to $3.5 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 $1.1 million increase in preclinical studies, offset by a reduction of $4.7 million in manufacturing costs.
Current wording
MICVO program-specific research and development costs decreased by $0.7 million, primarily due to a reduction of $3.6 million in manufacturing costs, partially offset by a $3.0 million increase in clinical trial-related expenses due to an increased number of patients dosed in the MICVO monotherapy and combination therapy trials.
Previous wording
PYX-106 program-specific research and development costs decreased by $0.2 million, reflecting lower program-related expenses following the pause in clinical development of PYX-106-101 in December 2024.
Current wording
PYX-106 program-specific research and development costs decreased by $0.4 million, reflecting lower program-related expenses following the pause in clinical development of PYX-106-101 in December 2024 and the termination of our license agreement with Biosion USA, Inc., effective August 2026.
Previous wording
General and administrative expenses increased by $4.5 million, from $5.4 million for the three months ended June 30, 2025 to $9.9 million for the three months ended June 30, 2026. This increase was primarily attributable to a $4.4 million increase in personnel-related expenses, due to an increase in severance costs of $1.2 million and higher stock-based compensation expense of $2.6 million.
Current wording
General and administrative expenses decreased by $1.7 million, from $5.7 million for the three months ended September 30, 2025 to $4.0 million for the three months ended September 30, 2026. This decrease was primarily attributable to lower stock-based compensation expense of $1.4 million.
Previous wording
Other income, net for the three months ended June 30, 2026 and 2025 was $0.6 million and $1.7 million, respectively. The decrease of $1.1 million was due to lower interest and investment income and lower sublease income.
Current wording
Other income, net for the three months ended September 30, 2026 and 2025 was $0.5 million and $1.5 million, respectively. The decrease of $0.9 million was due to lower interest and investment income and the absence of sublease income following the end of the sublease term in May 2026.
Previous wording
We recognized no revenue for the three months ended June 30, 2026, compared to $2.8 million for the three months ended June 30, 2025. The prior-year revenue related to a regulatory milestone achieved under the Simcere out-licensing and collaboration agreement.
Current wording
We recognized no revenue for the nine months ended September 30, 2026, compared to $2.8 million for the nine months ended September 30, 2025. The prior-year revenue related to a regulatory milestone achieved under the Simcere out-licensing and collaboration agreement.
Previous wording
The following table summarizes our research and development expenses for the six months ended June 30, 2026 and 2025 (in thousands):
Current wording
The following table summarizes our research and development expenses for the nine months ended September 30, 2026 and 2025 (in thousands):
Previous wording
MICVO program-specific research and development costs increased by $5.4 million, primarily due to $7.9 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 $1.9 million increase in preclinical studies, offset primarily by a reduction in manufacturing expense of $4.3 million.
Current wording
MICVO program-specific research and development costs increased by $4.7 million, primarily due to a $10.8 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 a $2.1 million increase in research and preclinical studies, partially offset by a reduction in manufacturing expense of $7.9 million.
Previous wording
PYX-106 program-specific research and development costs decreased by $0.7 million, reflecting lower program-related expenses following the pause in clinical development of PYX-106-101 in December 2024.
Current wording
PYX-106 program-specific research and development costs decreased by $1.1 million, reflecting lower program-related expenses following the pause in clinical development of PYX-106-101 in December 2024 and the termination of our license agreement with Biosion USA, Inc., effective August 2026.
Previous wording
Unallocated research and development costs decreased by $2.5 million primarily due to decreased severance expense of $0.9 million, a reduction in other research and development support costs of $0.7 million and decreased employee recruitment costs of $0.6 million.
Current wording
Unallocated research and development costs decreased by $2.5 million primarily due to decreased stock-based compensation expense of $1.2 million, decreased employee recruitment costs of $0.7 million and lower depreciation and amortization expense of $0.5 million.
Previous wording
The following table summarizes our general and administrative expenses for the six months ended June 30, 2026 and 2025 (in thousands):
Current wording
The following table summarizes our general and administrative expenses for the nine months ended September 30, 2026 and 2025 (in thousands):
Previous wording
General and administrative expenses increased by $3.0 million, from $11.3 million for the six months ended June 30, 2025 to $14.3 million for the six months ended June 30, 2026. This increase was primarily attributable to a $2.6 million increase in personnel-related expenses, primarily due to an increase in severance costs of $1.1 million and an increase in stock-based compensation expense of $0.9 million.
Current wording
General and administrative expenses increased by $1.3 million, from $17.0 million for the nine months ended September 30, 2025 to $18.3 million for the nine months ended September 30, 2026. This increase was primarily attributable to a $1.2 million increase in personnel-related expenses, primarily due to an increase in severance costs of $0.7 million, and a $0.3 million increase in professional and consultant fees.
Previous wording
Other income, net for the six months ended June 30, 2026 and 2025 was $1.7 million and $3.4 million, respectively. The decrease of $1.7 million was primarily due to lower interest and investment income and lower sublease income.
Current wording
Other income, net for the nine months ended September 30, 2026 and 2025 was $2.3 million and $4.9 million, respectively. The decrease of $2.6 million was primarily due to lower interest and investment income and lower sublease income, following the end of the sublease term in May 2026.
Previous wording
We had cash, cash equivalents and marketable debt securities of $33.0 million as of June 30, 2026, including $10.0 million from the Private Placement proceeds received in advance on June 30, 2026. For the three months ended June 30, 2026 and 2025, we had net losses of $25.3 million and $18.4 million, respectively. For the six months ended June 30, 2026 and 2025, we had net losses of $48.6 million and $39.5 million, respectively. As of June 30, 2026, we had an accumulated deficit of $491.8 million and net equity of $11.4 million.
Current wording
We had cash, cash equivalents and marketable debt securities of $55.6 million as of September 30, 2026. For the three months ended September 30, 2026 and 2025, we had net losses of $20.0 million and $22.0 million, respectively. For the nine months ended September 30, 2026 and 2025, we had net losses of $68.6 million and $61.5 million, respectively. As of September 30, 2026, we had an accumulated deficit of $511.8 million and net equity of $41.3 million.
Previous 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 and six months ended June 30, 2026 and 2025, we did not sell any shares under the ATM program. As of June 30, 2026, we had $150.0 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 included an at-the-market (“ATM”) offering program for the sale of up to $150.0 million of shares of our common stock. During the nine months ended September 30, 2026, we did not sell any shares under the ATM program, and on September 29, 2026, we terminated the ATM program.
Previous wording
On July 2, 2026, we completed the Private Placement with certain accredited investors and issued and sold to the Purchasers an aggregate of (i) 19,600,153 shares of common stock at a purchase price of $2.551 per share, and (ii) common warrants to purchase up to an equal amount of shares of common stock at an exercise price of $3.289 per Common Warrant. The Common Warrants will be exercisable on or after the earlier of (i) the date on which we first publicly disclose clinical data from MICVO Phase 1 monotherapy study in 2L+ R/M HNSCC, or (ii)
Current wording
On July 2, 2026, we completed a private placement (the “Private Placement”) with certain institutional accredited investors (the “Purchasers”) and issued and sold to the Purchasers an aggregate of (i) 19,600,153 shares of common stock at a purchase price of $2.551 per share, and (ii) common warrants (the “July 2026 Warrants”) to purchase up to an equal number of shares of common stock at an exercise price of $3.289 per share. The July 2026 Warrants became exercisable on September 9, 2026, the date on which we first publicly disclosed clinical data from our MICVO Phase 1 monotherapy study in 2L+ R/M HNSCC, and will expire on July 2, 2029. We received gross proceeds from the Private Placement of approximately $50.0 million, before deducting placement agent fees and offering expenses, and net proceeds of $48.3 million after deducting such fees and expenses.
Previous wording
the cost associated with monotherapy and combination therapy clinical trials for MICVO;
Current wording
the cost associated with ongoing monotherapy and combination therapy clinical trials 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 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.
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 our product candidate that we would otherwise prefer to develop and market ourselves.
Previous wording
During the six months ended June 30, 2025, net cash used in operating activities was $39.8 million, which consisted of our net loss of $39.5 million and a net change in our operating assets and liabilities of $6.4 million, partially offset by non-cash charges of $6.0 million. The non-cash charges of $6.0 million were primarily due to $6.6 million of stock-based compensation and $1.1 million of depreciation and amortization expenses, offset by $2.0 million related to accretion of discounts on marketable debt securities. The net change in our operating assets and liabilities was primarily due to an increase in receivables by $3.0 million, prepaid expenses and other current assets by $2.5 million, a decrease in accrued expenses and other current liabilities by $4.7 million and an increase in accounts payable by $4.5 million primarily related to the timing of vendor payments and services performed related to our ongoing clinical trials.
Current wording
During the nine months ended September 30, 2026, net cash used in operating activities was $60.5 million, which consisted of our net loss of $68.6 million and a net change in our operating assets and liabilities of $1.0 million, partially offset by non-cash charges of $9.1 million. The non-cash charges of $9.1 million were primarily due to $8.1 million of stock-based compensation, $1.1 million of depreciation and amortization expense and $0.7 million of non-cash operating lease expense, partially offset by $0.8 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 accounts payable of $2.8 million related to the timing of vendor payments, and a reduction in operating lease liabilities of $1.3 million, partially offset by a decrease in prepaid expenses and other current assets of $1.7 million and an increase in accrued expenses and other current liabilities of $1.4 million.
Previous wording
During the six months ended June 30, 2026, net cash used in operating activities was $44.2 million, which consisted of our net loss of $48.6 million, partially offset by non-cash charges of $7.5 million and a net change in our operating assets and liabilities of $3.1 million. The non-cash charges of $7.5 million were primarily due to $6.7 million of stock-based compensation, $0.8 million of depreciation and amortization expense and $0.5 million of non-cash operating lease expense, partially offset by $0.4 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 accounts payable of $7.6 million, partially offset by an increase in accrued expenses and other current liabilities of $4.0 million, primarily related to the timing of vendor payments and services performed related to our ongoing clinical trials. Further, net changes in our operating assets and liabilities also consists of a reduction in operating lease liabilities of $0.8 million and an increase in prepaid expenses and other current assets of $1.5 million.
Current 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 $9.4 million. The non-cash charges of $9.4 million were primarily due to $9.7 million of stock-based compensation, $1.6 million of depreciation and amortization expense and $0.6 million of non-cash operating lease expense, 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 accrued expenses and other current liabilities of $3.4 million, an increase in prepaid expenses and other current assets of $1.3 million and a reduction in operating lease liabilities of $1.1 million, partially offset by an increase in accounts payable of $4.9 million, primarily related to the timing of vendor payments and services performed related to our ongoing clinical trials.
Previous wording
During the six months ended June 30, 2026, net cash provided by investing activities was $37.7 million, which consisted primarily of redemptions of marketable debt securities of $51.7 million, partially offset by purchases of marketable debt securities of $14.0 million.
Current wording
During the nine months ended September 30, 2026, net cash provided by investing activities was $0.4 million, which consisted of redemptions of marketable debt securities of $63.7 million, partially offset by purchases of marketable debt securities of $63.4 million.
Previous wording
During the six months ended June 30, 2025, net cash provided by investing activities was $31.1 million, which consisted primarily of redemptions of marketable debt securities of $123.6 million, partially offset by purchases of marketable debt securities of $92.5 million.
Current wording
During the nine months ended September 30, 2025, net cash provided by investing activities was $42.6 million, which consisted of redemptions of marketable debt securities of $149.6 million, partially offset by purchases of marketable debt securities of $107.0 million.
Previous wording
During the six months ended June 30, 2026, net cash provided by financing activities was $10.0 million, which consisted primarily of proceeds received in advance of the Private Placement, partially offset by tax withholding payments related to net settlement of restricted common stock.
Current wording
During the nine months ended September 30, 2026, net cash provided by financing activities was $48.6 million, which consisted primarily of net proceeds from the Private Placement of $48.3 million and proceeds from the exercise of stock options of $0.3 million, partially offset by tax withholding payments related to net settlement of restricted common stock of $0.1 million.
Previous wording
During the six months ended June 30, 2025, net cash used in financing activities was $0.1 million, which consisted primarily of tax withholding payments related to the net settlement of restricted common stock.
Current wording
During the nine months ended September 30, 2025, net cash used in financing activities was $0.1 million, which consisted primarily of tax withholding payments related to the net settlement of restricted common stock.
Previous wording
As of June 30, 2026, we had approximately $33.0 million in cash, cash equivalents and marketable debt securities. Additionally, on July 2, 2026, we completed the Private Placement which resulted in gross proceeds of approximately $50 million (of which $10.0 million was received on June 30, 2026), before deducting placement agent commissions and offering expenses. We believe that our cash, cash equivalents and marketable debt securities as of June 30, 2026, along with the proceeds from the Private Placement will be sufficient to fund our operations into the second quarter of 2027. However, we have based this estimate on assumptions that may prove to be incorrect, and our operating plan may change as a result of many factors currently unknown to us. In addition, we may utilize our available capital resources sooner than we expect.
Current wording
As of September 30, 2026, we had approximately $57.0 million in cash, cash equivalents, restricted cash and marketable debt securities. Additionally, on October 1, 2026, we completed the Public Offering which resulted in gross proceeds of approximately $110.0 million, before deducting underwriting discounts and commissions and offering expenses, and we may receive up to approximately $172.6 million of additional gross proceeds if all of the October 2026 Warrants and pre-funded warrants are exercised in full for cash. Our cash, cash equivalents, restricted cash and marketable debt securities as of September 30, 2026, together with the net proceeds from the Public Offering, will be sufficient to fund our operating expenses and capital expenditure requirements into the first half of 2028. However, we have based this estimate on assumptions that may prove to be incorrect, and our operating plan may change as a result of many factors currently unknown to us. In addition, we may 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%. The remaining contractual fixed lease payments, over the term of the lease aggregate to $24.1 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%. The remaining contractual fixed lease payments over the term of the lease aggregate to $23.3 million. The operating lease obligation is discussed in Note 10, Operating 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
There have been no significant changes to our critical accounting policies and estimates as compared to those described in “Note 2 – Summary of Significant Accounting Policies” to our audited financial statements set forth in our Fiscal 2025 10-K.
Current wording
There have been no significant changes to our critical accounting policies and estimates as compared to those described in “Note 2 – Basis of Presentation and Summary of Significant Accounting Policies” to our audited consolidated financial statements set forth in our Fiscal 2025 10-K.
Previous 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.
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, Basis of Presentation and 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 previous paragraphs (3)
Previous report — wording carried elsewhere
MICVO monotherapy for 2L and 3L R/M HNSCC patients who have received prior platinum-based chemotherapy and prior PD-(L)1 inhibitor therapy; and
Previous report — wording carried elsewhere
MICVO monotherapy for 2L and 3L R/M HNSCC patients who have received prior EGFR directed therapy and prior PD-(L)1 inhibitor therapy.
Previous report — wording carried elsewhere
We recognized no revenue for the six months ended June 30, 2026, compared to $2.8 million for the six months ended June 30, 2025. The prior-year revenue related to a regulatory milestone achieved under the Simcere out-licensing and collaboration agreement.