Pyxis Oncology, Inc.
For the period ended Mar 31, 2025. Filed May 15, 2025.
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A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Mar 31, 2025 · Filed May 15, 2025
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 2024-09-30; filed 2024-11-12.
0000950170-24-124602
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2025-03-31; filed 2025-05-15.
0000950170-25-071996
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
Compared 128 previous paragraphs and 128 current paragraphs.
57 unchanged; 25 reworded; 46 added; 43 removed; 3 previous and 0 current paragraphs rearranged.
Tables are not compared: 7 previous and 4 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
Added paragraphs (46)
Current report
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 report
Our 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 extracellular matrix (ECM). The tumor ECM is a complex network of fibrous proteins and molecules with unique composition that play an important role in cell development and tumor growth and in some instances, in supporting metastasis. The fibronectin strands within the ECM give the tumor shape and support the clustering of tumor cells.
Current 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.
Current report
Our ADC, micvotabart pelidotin, consists of human Immunoglobulin G1 (IgG1) and is site-specifically conjugated with a cleavable linker and a microtubule inhibitor (optimized auristatin) payload. Micvotabart pelidotin is designed to optimize linker stability to enable delivery of the next generation auristatin payload that can be cleaved and released in the ECM and penetrate through the tumor cell membrane to kill tumor cells directly without the need for cell surface antigen-mediated internalization of the ADC. Unlike conventional ADCs which bind to the tumor cell surface antigens, micvotabart pelidotin is designed to deliver the auristatin payload to the extracellular environment and release the free payload to kill tumor cells as well as activated fibroblasts and vascular endothelial cells that support tumor growth. We believe the free payload kills the tumor cells through a combination of bystander effect directly killing highly proliferative cells and through stimulation of the local immune cells.
Current report
We conducted a Phase 1 dose escalation (Part 1) study, referred to as PYX-201-101 to evaluate micvotabart pelidotin monotherapy in patients with advanced solid tumors predicted to express EDB+FN. A total of 80 patients were dosed across nine solid tumor types during the PYX-201-101 (Part 1) study. In November 2024, we announced positive preliminary data from Part 1 of our Phase 1 dose escalation study of PYX-201-101 with a data cut-off date of October 4, 2024.
Current report
The recurrent and metastatic head and neck squamous cell carcinoma (R/M HNSCC) patients were observed to show the strongest tumor regression response during this Part 1 phase of the study. Among the six efficacy evaluable patients with R/M HNSCC at the therapeutically active dose response range of 3.6 mg/kg – 5.4 mg/kg IV Q3W, the study achieved a confirmed 50% objective response rate (ORR) based on RECIST 1.1 criteria including one confirmed complete response (cCR) and two confirmed partial responses (cPRs) and yielded a disease control rate (DCR) of 100%. These six heavily pre-treated patients with R/M HNSCC had either HPV-positive (HPV+) or HPV-negative (HPV-) tumors and a median of four prior lines of systemic therapy in the advanced disease setting.
Current report
While we observed evidence of tumor regression across all nine solid tumor types that were enrolled in the Phase 1 Part 1 dose escalation study, dose responses were most pronounced in six solid tumor types of interest, including R/M HNSCC, hormone receptor positive and human epidermal growth factor receptor 2 negative (HR+/HER2-) breast cancer, locally advanced / metastatic non-small cell lung cancer (NSCLC), ovarian cancer, sarcoma and triple negative breast cancer (TNBC), at the therapeutically active dose response range of 3.6 mg/kg – 5.4 mg/kg IV Q3W. Micvotabart pelidotin achieved a 26% ORR (n=31) in patients with these six solid tumor types dosed at 3.6 mg/kg – 5.4 mg/kg IV Q3W.
Current report
Recent Preclinical Data
Current report
Recently, we presented new preclinical data at the 2025 American Association for Cancer Research (AACR), Annual Meeting in Chicago. We observed broad anti-tumor activity for micvotabart pelidotin across ten solid tumor indications in PDX models, attributed to EDB+FN target expression, proteolytic activity for micvotabart pelidotin linker cleavage and tumor responsiveness to the optimized cytotoxic Auristatin0101 payload. The preclinical data is summarized below:
Current report
45% of models demonstrated strong to very strong tumor growth inhibition (TGI%) activity (70%<TGI<90% or TGI>90% respectively), with only 25% of models showing no response (TGI<25%).
Current report
PDX models with very strong activity (TGI>90%) were found across nine out of ten solid tumor indications.
Current report
Complete responses to micvotabart pelidotin (tumor volume reached 0mm 3 for at least two consecutive measurements) were found across several tumor indications, consistent with previous analysis.
Current report
micvotabart pelidotin was observed to be well-tolerated (3mg/kg, Q4Dx4).
Current report
We also performed differential gene expression analysis, which enabled us to identify gene signatures linked to anti-tumor activity consistent with our extracellular ADC hypothesis. We observed that enzyme and tumor stroma gene signatures were the gene sets with the greatest number of differentially expressed genes. Further, the preclinical data shows upregulation of certain proteases that may contribute to increased linker cleavage and subsequent increased anti-tumor activity for micvotabart pelidotin, supporting our extracellular hypothesis.
Current report
We also conducted preclinical studies combining a mouse analog of micvotabart pelidotin with anti-PD-1 therapy. The combination of a mouse analog of micvotabart pelidotin with anti-PD-1 therapy inhibited EMT6 tumor growth and improved survival compared to either treatment alone, suggesting potential benefit for combination therapy to deepen anti-tumor responses in solid tumors. The preclinical studies combining a mouse analog of micvotabart pelidotin with anti-PD-1 therapy is summarized below:
Current report
Monotherapy of mouse analog of micvotabart pelidotin inhibited dose-dependent tumor outgrowth of EDB+FN expressing EMT6 tumors and was well-tolerated at 6 mg/kg.
Current report
The mouse analog of micvotabart pelidotin boosted the immune response by activating dendritic cells and increasing CD45+ immune cell infiltration, including PD-1+ T cells, into tumors, transforming EMT6 tumors into immune-infiltrated, "hot" tumors.
Current report
Significant TGI observed with mouse analog of micvotabart pelidotin (TGI=94%) and anti-PD-1 therapy (TGI=54%) as monotherapies.
Current report
The combination of the mouse analog of MICVO and anti-PD-1 therapy resulted in TGI of 91% and complete response was seen in 9/15 animals – greater tumor regression and clearance than either treatment alone.
Current report
Mouse analog of micvotabart pelidotin in combination with anti-PD1 therapy induced lasting immunological memory, enhancing tumor clearance and protecting against tumor recurrence in rechallenged mice.
Current report
The preclinical data indicated micvotabart pelidotin alone may be eliciting immune responses in previously unresponsive tumors, as observed with the infiltration of T cells into the tumor, representing potential for micvotabart pelidotin to drive immunogenic cell death. Together, these preclinical data further support the three-pronged mechanism of action of micvotabart pelidotin driving anti-tumor activity via direct tumor killing, bystander effect and immunogenic cell death.
Current report
We believe the totality of our preliminary clinical and preclinical data supports further development of both micvotabart pelidotin monotherapy expansion and combination therapy trials.
Current report
Our Clinical Pipeline
Current 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.
Current 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.
Current report
The following table summarizes our clinical pipeline:
Current report
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. Currently, we are enrolling and dosing patients for two monotherapy R/M HNSCC expansion cohorts. The Part 2 dose expansion phase includes the following two R/M HNSCC cohorts across sites in the United States (US), European Union (EU) and other countries:
Current report
micvotabart pelidotin monotherapy for second line (2L) and third line (3L) R/M HNSCC patients who have received prior platinum-based chemotherapy and prior PD-(L)1 inhibitor therapy. We expect to enroll approximately 20 patients in this expansion cohort at the 5.4 mg/kg IV Q3W dose, a pharmacologically active dose identified during Part 1 of this trial where we have seen clinically meaningful anti-tumor activity with manageable safety. We anticipate having preliminary data in the second half of 2025; and
Current report
micvotabart pelidotin monotherapy for 2L and 3L R/M HNSCC patients who have received prior epidermal growth factor receptor (EGFR) directed therapy and prior PD-(L)1 inhibitor therapy. We expect to enroll approximately 20 patients in this expansion cohort also at the 5.4 mg/kg IV Q3W dose and anticipate having preliminary data in the first half of 2026.
Current report
We are planning to hold a discussion with the FDA to align on our approach for finding the optimal monotherapy dose, as required under Project Optimus and expect the dose optimization phase to commence in 2026.
Current report
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).
Current report
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 report
We initiated Part 1 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. Currently, we are enrolling and dosing patients to clear the three doses that will be tested in combination with pembrolizumab. During Part 1 dose escalation, we anticipate testing a fixed dose of pembrolizumab in combination with 3 different doses of micvotabart pelidotin ranging from 3.6 mg/kg – 5.4 mg/kg IV Q3W. Pembrolizumab (standard dose at 200 mg IV) will be given with escalating doses of micvotabart pelidotin with a starting dose of 3.6 mg/kg IV every 3 weeks (Q3W). Upon clearance of the initial dose level of 3.6 mg/kg IV Q3W by the Dose Escalation and Steering Committee (DESC), and depending on observed safety data, we may escalate to 4.4 mg/kg IV Q3W of micvotabart pelidotin with 200 mg IV of pembrolizumab, with a potential of dosing at 5.4 mg/kg IV Q3W of micvotabart pelidotin with 200 mg IV of pembrolizumab. 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.
Current report
Concurrently to the Part 1 dose escalation and assuming each dose clears the escalation step, the Phase 1/2 combination study will evaluate micvotabart pelidotin and pembrolizumab in patients with 1L and 2L+ R/M HNSCC. We expect to enroll approximately 20 patients, which will be enrolled for each dose in their respective backfill cohort upon clearance of the dose by the DESC. Pembrolizumab (standard dose at 200 mg IV) will be given with escalating doses of micvotabart pelidotin with a starting dose of 3.6 mg/kg IV every 3 weeks, followed by dose of 4.4 mg/kg IV Q3W, if DESC clears it and then a dose of 5.4 mg/kg IV Q3W, if DESC clears it. We anticipate 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 mid-year of 2025.
Current report
The components of our cost of revenues are expenses directly attributable to revenues. During the three months ended March 31, 2025, the Company has not incurred any costs with respect to revenue.
Current report
Research and Development Expenses
Current report
General and Administrative Expenses
Current report
Other Income, Net
Current report
Research and Development Expenses
Current report
PYX-106 program-specific research and development costs decreased by $1.0 million as we paused the clinical development of PYX-106-101 in December 2024.
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Removed paragraphs (43)
Previous report
We are a clinical stage company focused on defeating difficult-to-treat cancers. We are efficiently building next generation therapeutics that hold the potential for mono and combination therapies. We develop our product candidates with the objective to kill tumor cells, and to address the underlying pathologies created by cancer that enable its uncontrollable proliferation and immune evasion. Since our launch in 2019, we have developed a broad portfolio that includes antibody-drug conjugates, or ADC, product candidates, and immuno-oncology, or IO, product candidates. Our ADC and IO programs employ novel and emerging strategies to target a broad range of solid tumors resistant to current standards of care.
Previous report
Our pipeline is balanced across programs with an emphasis on solid tumors. We in-licensed two ADC programs in March 2021 from Pfizer and one IO program from Biosion in March 2022. Additionally, upon the acquisition of Apexigen in August 2023, we added another IO program to our pipeline. We have additional preclinical monoclonal antibody, or mAb, discovery programs derived from the work at the laboratory of Dr. Thomas Gajewski. We retain full worldwide development and commercialization rights to all our product candidates, with the exception of PYX-106 in Greater China (mainland China, Hong Kong, Macau and Taiwan).
Previous report
Our clinical development pipeline focused on multiple difficult-to-treat tumors is displayed below:
Previous report
Our Clinical Program Portfolio
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PYX-201
Previous report
Our lead ADC product candidate is PYX-201, an investigational, novel ADC consisting of human Immunoglobulin G1, or IgG1, site-specifically conjugated with a next generation auristatin derivative via proteases-cleavable linker. PYX-201 is an ADC with an inhibitor of microtubule polymerization payload that uniquely targets Extradomain-B Fibronectin, or EDB+FN, a non-cellular structural component of the tumor extracellular matrix. EDB+FN regulates blood vessel morphogenesis, which provides the tumor access to nutrition and oxygen, a means to remove waste and a pathway for metastasizing cells.
Previous report
In preclinical models of patient-derived xenograft, or PDX models, we observed tumor regression with single agent PYX-201 in a dose-dependent manner. In addition, we observed that the treatment of preclinical syngeneic tumor models with PYX-201 resulted in enhanced T-cell infiltration into the tumor microenvironment, or TME, suggesting that PYX-201 may have caused immunogenic cell death, or ICD, and could potentially trigger downstream anti-tumor immune response. We shared our latest preclinical data at the 2024 American Association for Cancer Research, or AACR, Annual Meeting in San Diego, California. The preclinical data supports that PYX-201 is designed to have improved plasma stability, better potency, and tumor permeability due to optimized auristatin payload, or Aur-0101, and improved linker stability through site-specific conjugation to engineered cysteine residues for a target drug-to-antibody ratio, or DAR, of 4. Across a panel of approximately 100 preclinical PDX models representing ten tumor types, PYX-201 demonstrated broad, deep and durable anti-tumor activity. The preclinical data provides insights into the mechanism associated with this novel agent observed across multiple solid tumors. PYX-201 has potential applications in both monotherapy and combination therapy and maintains a well-tolerated safety profile based on the lack of EDB+FN expression in healthy cells.
Previous report
In December 2022, we announced clearance of our investigational new drug application, or IND, by the U.S. Food and Drug Administration, or FDA, to initiate a Phase 1 clinical trial. During the first quarter of 2023, we announced dosing of the first subject in a Phase 1 trial of PYX-201, referred to as PYX-201-101. PYX-201-101 is an open-label, multicenter, dose-escalation trial designed to evaluate the safety, tolerability, pharmacokinetics, or PK, pharmacodynamics, or PD, and preliminary efficacy of PYX-201 and identify recommended doses for further study. Patients with relapsed or refractory solid tumors, including non-small cell lung cancer, or NSCLC, locally advanced/metastatic breast cancer, hormone receptor and human epidermal growth factor receptor 2 positive and negative, or HR+ HER- and HR- HER2+, breast cancers, triple negative breast cancer, or TNBC, ovarian cancer, thyroid cancer, pancreatic ductal adenocarcinoma, or PDAC, soft tissue sarcoma, or STS, hepatocellular carcinoma, or HCC, head and neck squamous cell carcinoma, or HNSCC, and kidney cancer are eligible to enroll in this study. In May 2023, the FDA granted Orphan Drug Designation, or ODD, for use of PYX-201 in the treatment of pancreatic cancer.
Previous report
In the Phase 1 portion of the trial, the starting dose of PYX-201 was 0.3 mg/kg. The Dose Escalation Steering Committee, or DESC, approved escalating the dose after each cohort. PYX-201 is administered once every three weeks. Dose escalation follows the Bayesian Optimal Interval, or BOIN, design until the recommended Part 2 dose(s), or RP2D, is determined.
Previous report
To date, 80 subjects have been dosed in the PYX-201 dose escalation study with a continued focus on HNSCC, NSCLC, ovarian cancer, soft tissue sarcoma, and PDAC based on an assessment of factors including immunohistochemistry target expression, stromal volume, unmet medical need, and clinical investigator judgment. PYX-201 safety data continues to support go-forward monotherapy and potential combination clinical development strategies, which we believe could have the potential to provide additional treatment options to patients with difficult-to-treat cancers.
Previous report
As we continue to analyze the data generated, we anticipate that the data from the dose finding studies will guide the selection for the RP2D for subsequent multi-dosing and potential combination studies. We anticipate announcing preliminary data from the Phase 1 trial of PYX-201, including efficacy, safety, pharmacokinetics (PK), and provide an update on future development plans during the second half of November 2024.
Previous report
PYX-106
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Our lead IO product candidate is PYX-106, an investigational, fully human IgG1 Siglec-15-targeting antibody designed to block Siglec-15 mediated suppression of T-cell proliferation and function. PYX-106 has high binding affinity to a unique epitope and high potency. Overall, by binding and blocking Siglec-15 activity on myeloid cells and tumors, our Siglec-15 targeting antibody is designed to enhance immune cell mediated tumor cell killing. We are developing this asset for the treatment of solid tumors and believe that PYX-106 has the potential to provide additional benefit to patients either alone or in combination with other therapies, including other immuno-therapies.
Previous report
Preclinical studies provided us sufficient scientific rationale about the effect of blocking Siglec-15 in various animal models. PYX-106 was observed as well tolerated with no evidence of anti-drug antibodies. Further, PYX-106 was observed to have 7 days of half-life in monkeys in our preclinical studies. If the half-life of 7 days were observed in humans, it would allow for less frequent dosing, maintain exposure and target engagement.
Previous report
In December 2022, we announced clearance of our IND by the FDA for PYX-106 to initiate a Phase 1 clinical trial. During the second quarter of 2023, we announced dosing of the first subject in a Phase 1 trial of PYX-106, referred to as PYX-106-101. PYX-106-101 is a first-in-human, Phase 1, multicenter, open-label dose escalation trial designed to evaluate the safety, tolerability, PK, PD, and preliminary efficacy of PYX-106 and identify recommended doses for further study. Patients with relapsed or refractory solid tumors, including non-small cell lung cancer without driver mutations/translocations, breast cancer, endometrial cancer, thyroid cancer, kidney cancer, cholangiocarcinoma, bladder cancer, colorectal cancer, and HNSCC are eligible to enroll in this study.
Previous report
In the Phase 1 portion of the trial, the starting dose of PYX-106 was 0.5 mg/kg. The DESC approved escalating the dose after each cohort. To date, 45 subjects have been dosed with PYX-106 in the Phase 1 trial. PYX-106 is administered once every two weeks. Dose escalation will follow the BOIN design until the RP2D is determined.
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We expect to report preliminary data from the Phase 1 trial of PYX-106, including PK/pharmacodynamic results, by year-end 2024.
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PYX-107
Previous report
On August 23, 2023, we completed the acquisition of Apexigen, a Delaware corporation and a clinical-stage biopharmaceutical company focused on discovering and developing innovative antibody therapeutics for oncology.
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The acquisition of Apexigen expanded our existing pipeline with the addition of sotigalimab (now PYX-107), a CD40 agonist with demonstrated anti-cancer activity in patients who previously progressed on PD-(L)1 inhibitors. PYX-107 has been evaluated in more than 500 patients in clinical trials and demonstrated strong activity, including rapid, deep and durable responses and a favorable tolerability profile, across multiple difficult-to-treat tumor types. In a Phase II trial, PYX-107 in combination with nivolumab has demonstrated strong activity in melanoma patients who are refractory to anti-PD-(L)1, with a 15.2% partial response rate and a 30.3% stable disease rate along with a favorable tolerability profile. Opportunity to advance clinical development of PYX-107 will be further assessed as part of portfolio evaluation.
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 6. Sale of Royalty Rights, to our unaudited condensed consolidated financial statements included in Part I, Item 1 of this Quarterly Report on Form 10-Q for further information.
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PYX-106 program-specific research and development costs increased by $0.9 million, primarily due to a $0.6 million increase in clinical trial related expenses and $0.3 million increase in contract manufacturing costs for our ongoing Phase 1 clinical trial for PYX-106-101.
Previous report
Unallocated research and development costs decreased by $4.0 million from $10.6 million for the three months ended September 30, 2023, to $6.6 million for the three months ended September 30, 2024. This decrease was primarily due to lower personnel-related expenses as a result of the reduction in workforce completed in the fourth quarter of 2023.
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Results of Operations
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Comparison of the Nine Months Ended September 30, 2024 and 2023
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The following table summarizes our results of operations for the nine months ended September 30, 2024 and 2023 (in thousands):
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Costs and Operating Expenses
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Cost of Revenues
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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.
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Research and development expenses increased by $6.7 million, from $38.0 million for the nine months ended September 30, 2023, to $44.7 million for the nine months ended September 30, 2024.
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PYX-201 program-specific research and development costs increased by $12.6 million, primarily due to a $3.2 million increase in clinical trial related expenses for our ongoing Phase 1 clinical trial for PYX-201-101, a $7.6 million increase in contract manufacturing costs due to timing of manufacturing runs for PYX-201 and a $1.2 million increase in pre-clinical and translation work related to our ongoing clinical trial for PYX-201-101.
Previous report
PYX-106 program-specific research and development costs increased by $2.3 million, primarily due to a $1.8 million increase in clinical trial related expenses and $0.2 million increase in contract manufacturing costs for our ongoing Phase 1 clinical trial for PYX-106-101.
Previous report
Unallocated research and development costs decreased by $8.6 million from $28.2 million for the nine months ended September 30, 2023, to $19.6 million for the nine months ended September 30, 2024. This decrease was primarily due to lower personnel-related expenses as a result of the reduction in workforce completed in the fourth quarter of 2023.
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General and administrative expenses decreased by $6.1 million, from $26.5 million for the nine months ended September 30, 2023, to $20.3 million for the nine months ended September 30, 2024. The decrease was primarily related to higher professional and consultant fees of $2.7 million, stock-based compensation of $1.9 million and severance costs of $1.4 million during the prior comparable period, partially offset by higher depreciation on leasehold improvements of $0.9 million in the current period.
Previous report
Other income, net for the nine months ended September 30, 2024 and 2023 was $7.6 million and $6.2 million, respectively. The increase was primarily due to higher sublease income due to a full period of sublease income for 2024 as compared to a partial period for 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
the cost associated with Phase 1 clinical trials for PYX-201 and PYX-106;
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Reworded paragraphs (25)
Previous wording
We believe EDB+FN within the tumor extracellular matrix may be an ideal target to address in many cancers with high unmet need. The extracellular matrix plays a major role in the initiation, growth, survival, invasion and drug-resistance of solid tumors, yet few therapeutics specifically target non-cellular structural components of the tumor-associated stroma. By targeting EDB+FN and specifically attacking the non-cellular structural component of the tumor extracellular matrix, our goal is to destabilize the barrier that protects, feeds and provides structure to the tumor in addition to killing tumor cells directly. EDB+FN is overexpressed in many malignancies and is minimally expressed in most normal adult tissues, making it a potentially attractive means to target tumors while sparing healthy cells.
Current wording
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 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 revenues from product sales. We have incurred significant operating losses since our inception. We reported net losses of $41.8 million and $58.2 million for the nine months ended September 30, 2024 and 2023, respectively. As of September 30, 2024, we had an accumulated deficit of $328.0 million, net equity of $153.7 million, and cash, cash equivalents and short-term investments of $144.8 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 $21.2 million and $3.3 million for the three months ended March 31, 2025 and 2024, respectively. As of March 31, 2025, we had an accumulated deficit of $384.7 million, net equity of $103.1 million, and cash, cash equivalents and short-term investments of $105.4 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.
Previous wording
Our ability to generate product revenues will depend upon our ability to successfully develop, obtain regulatory approval and commercialize our product candidates. Due to the numerous risks and uncertainties associated with product development and regulatory approval, we are unable to predict the amount, timing or whether we will be able to obtain product revenues.
Current wording
Our ability to generate product revenues will depend upon our ability to successfully develop, obtain regulatory approval and commercialize our product candidate. Due to the numerous risks and uncertainties associated with product development and regulatory approval, we are unable to predict the amount, timing or whether we will be able to obtain product revenues.
Previous wording
direct third-party costs, which include expenses incurred under agreements with contract research organizations, or CROs, and the cost of consultants who assist with the development of our product candidates on a program-specific basis, investigator grants, sponsored research and any other third-party expenses directly attributable to the development of the product candidates;
Current wording
direct third party costs, which include expenses incurred under agreements with contract research organizations (CROs), and the cost of consultants who assist with the development of our product candidate on a program-specific basis, investigator grants, sponsored research, and any other third party expenses directly attributable to the development of the product candidate;
Previous wording
costs of acquiring, developing, and manufacturing and testing clinical and preclinical materials, including costs incurred under agreements with contract development and manufacturing organizations, or CDMOs, to the extent they can be allocated to a specific program;
Current wording
costs of acquiring, developing, and manufacturing and testing clinical and preclinical materials, including costs incurred under agreements with contract development and manufacturing organizations (CDMOs) to the extent they can be allocated to a specific program;
Previous wording
costs associated with preclinical activities that are directly attributable to the development of the product candidates.
Current wording
costs associated with preclinical activities that are directly attributable to the development of the product candidate.
Previous wording
We expect that our research and development expenses will increase substantially in connection with our ongoing and planned preclinical and clinical development activities in the near term and in the future. The successful development of our product candidates is highly uncertain. At this time, we cannot accurately estimate or know the nature, timing and costs of the efforts that will be necessary to complete the preclinical and clinical development of any of our product candidates and we may never succeed in obtaining regulatory approval for any of our product candidates.
Current wording
We expect that our research and development expenses will increase substantially in connection with our ongoing and planned preclinical and clinical development activities in the near term and in the future. The successful development of our product candidate is highly uncertain. At this time, we cannot accurately estimate or know the nature, timing and costs of the efforts that will be necessary to complete the preclinical and clinical development of any of our product candidate and we may never succeed in obtaining regulatory approval for any of our product candidate.
Previous wording
Revenues for the nine months ended September 30, 2024, was $16.1 million, compared to $0 for the nine months ended September 30, 2023. During the first quarter of fiscal 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 and 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 nine months ended September 30, 2024.
Current wording
Revenues for the quarter ended March 31, 2025, were $0, compared to $16.1 million for the quarter ended March 31, 2024. In March 2024, we entered into the settlement agreement with Novartis, pursuant to which we transferred our rights to future royalties on the net sales of Beovu® to Novartis for a one-time amount of $8.0 million. Novartis also agreed to forgo its right to reclaim royalties previously paid of $8.1 million to us and Apexigen.
Previous wording
Research and development expenses increased by $3.0 million, from $14.7 million for the three months ended September 30, 2023, to $17.7 million for the three months ended September 30, 2024.
Current wording
Research and development expenses increased by $4.0 million, from $13.0 million for the three months ended March 31, 2024 to $17.0 million for the three months ended March 31, 2025.
Previous wording
PYX-201 program-specific research and development costs increased by $5.9 million, primarily due to a $1.6 million increase in clinical trial related expenses for our ongoing Phase 1 clinical trial for PYX-201-101, a $2.9 million increase in contract manufacturing costs due to timing of manufacturing runs for PYX-201 and a $0.8 million increase in pre-clinical and translation work related to our ongoing Phase 1 clinical trial for PYX-201-101.
Current wording
Micvotabart Pelidotin program-specific research and development costs increased by $2.7 million, primarily due to a $1.1 million increase in contract manufacturing costs due to the timing of manufacturing runs for micvotabart pelidotin, $0.8 million increase in clinical trial related expenses related to our dose expansion phase (Part 2) of the PYX-201-101 monotherapy study and trial set up costs related to combination study, PYX-201-102, and $0.4 million increase in preclinical and translation work to support clinical development work of micvotabart pelidotin .
Previous wording
General and administrative expenses decreased by $4.7 million, from $10.7 million for the three months ended September 30, 2023, to $6.0 million for the three months ended September 30, 2024. The decrease was primarily related to higher severance costs of $1.6 million, professional and consultant fees of $0.9 million and stock-based compensation of $2.1 million during the prior comparable period, partially offset by higher depreciation on leasehold improvements of $0.3 million in the current period.
Current wording
General and administrative expenses decreased by $2.4 million, from $8.3 million for the three months ended March 31, 2024 to $5.9 million for the three months ended March 31, 2025. The decrease was primarily related to decrease in stock-based compensation by $1.2 million, decrease in professional and consultant fees and lower corporate insurance cost.
Previous wording
Other income, net for the three months ended September 30, 2024 and 2023 was $2.6 million and $2.3 million, respectively. The increase was primarily due to higher interest and investment income due to higher investment balances and higher interest rates.
Current wording
Other income, net for the three months ended March 31, 2025 and 2024 was $1.8 million and $2.3 million, respectively. The decrease was primarily due to a decrease in interest and investment income as compared to the previous quarter.
Previous wording
We had cash, cash equivalents and short-term investments of $144.8 million as of September 30, 2024. For the three and nine months ended September 30, 2024, we had net losses of $21.2 million and $41.8 million, respectively, as compared to $23.0 million and $58.2 million for the corresponding prior year periods. As of September 30, 2024, we had an accumulated deficit of $328.0 million.
Current wording
We had cash, cash equivalents and short-term investments of $105.4 million as of March 31, 2025. For the three months ended March 31, 2025 and 2024, we had net losses of $21.2 million and $3.3 million, respectively. As of March 31, 2025, we had an accumulated deficit of $384.7 million.
Previous wording
On November 1, 2022, we filed a registration statement on Form S-3 with the SEC for the issuance of common stock, preferred stock, warrants, debt securities, rights and units up to an aggregate of $250.0 million. On November 14, 2022, the registration statement was declared effective by the SEC. The registration statement includes an at-the-market, or ATM, offering program for the sale of up to $125.0 million of shares of our common stock.
Current wording
On November 1, 2022, we filed a registration statement on Form S-3 with the SEC for the issuance of common stock, preferred stock, warrants, debt securities, rights and units up to an aggregate of $250.0 million. On November 14, 2022, the registration statement was declared effective by the SEC. The registration statement includes an at-the-market, or ATM, offering program for the sale of up to $125.0 million of shares of our common stock. As of March 31, 2025, we had $106.2 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 the clinical trials for our product candidates in development. The timing and amount of our funding requirements will depend on many factors, including:
Current wording
We expect our expenses to increase substantially in connection with our ongoing activities, particularly as we advance clinical trials for our product candidate in development. The timing and amount of our funding requirements will depend on many factors, including:
Previous wording
the manufacture of drug products and drug substance for our product candidates PYX-201 and PYX-106;
Current wording
the manufacture of drug products and drug substance for micvotabart pelidotin;
Previous wording
the cost and timing of regulatory licenses;
Current wording
the cost and timing of regulatory licenses; and
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
During the nine months ended September 30, 2023, net cash used in operating activities was $55.5 million, which consisted of our net loss of $58.2 million and a net change in our operating assets and liabilities of $9.4 million, partially offset by non-cash charges of $12.1 million. The non-cash charges of $12.1 million was primarily due to $13.7 million in stock-based compensation and $3.3 million of accretion of discounts on marketable debt securities as well as $1.2 million of depreciation expense. The net change in our operating assets and liabilities was primarily due to a decrease of $10.4 million in accrued expenses, which 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 $3.9 million resulting from the timing of payments to our service providers. This decrease is partially offset by a $2.7 million increase to operating lease liabilities driven by tenant improvement allowance deposits.
Current wording
During the three months ended March 31, 2025, net cash used in operating activities was $22.5 million, which consisted of our net loss of $21.2 million and a net change in our operating assets and liabilities of $4.6 million, partially offset by non-cash charges of $3.2 million. The non-cash charges of $3.2 million was primarily due to $3.6 million of stock-based compensation, $0.6 million of depreciation and amortization expenses, offset by $1.2 million related to accretion of discounts on marketable debt securities. The net change in our operating assets and liabilities was primarily due to decrease in accounts payable by $2.0 million, accrued expenses and other current liabilities by $1.3 million and reduction in prepaid expenses by $0.9 million primarily related to the timing of vendor payments and services performed related to our ongoing clinical trials.
Previous wording
During the nine months ended September 30, 2024, net cash used in operating activities was $38.4 million, which consisted of our net loss of $41.8 million and a net change in our operating assets and liabilities of $5.2 million, partially offset by non-cash charges of $8.5 million. The non-cash charges of $8.5 million was primarily due to $10.2 million of stock-based compensation, $2.4 million of depreciation and amortization expense, offset by $4.6 million of accretion of discounts on marketable debt securities. The net change in our operating assets and liabilities was primarily due to a decrease in deferred revenues of $7.7 million related to the Settlement Agreement with Novartis and reductions in accrued expenses and other current liabilities driven primarily by the timing of payments and services performed related to our ongoing clinical trials.
Current wording
During the three months ended March 31, 2024, net cash used in operating activities was $20.7 million, which consisted of our net loss of $3.3 million and a net change in our operating assets and liabilities of $21.8 million, partially offset by non-cash charges of $4.3 million. The non-cash charges of $4.3 million was primarily due to $4.3 million of stock-based compensation, $1.1 million of depreciation and amortization expense, offset by $1.3 million of accretion of discounts on marketable debt securities. The net change in our operating assets and liabilities was primarily due to an increase in accounts receivable of $8.0 million and a decrease in deferred revenues of $7.7 million related to the Settlement Agreement with Novartis, and reductions in prepaid expenses and other current assets and accounts payable driven primarily by the timing of payments and services performed related to our ongoing clinical trials.
Previous wording
During the nine months ended September 30, 2024, net cash used in investing activities was $18.5 million, which consisted primarily of purchases of marketable debt securities of $155.7 million, partially offset by redemption of marketable debt securities of $137.5 million.
Current wording
During the three months ended March 31, 2024, net cash used in investing activities was $18.5 million, which consisted primarily of purchases of marketable debt securities of $92.8 million and purchases of property and equipment of $0.2 million, partially offset by redemption of marketable debt securities of $74.5 million.
Previous wording
During the nine months ended September 30, 2024, net cash provided by financing activities was $59.3 million, which consists primarily of net proceeds of $46.9 million from the Private Placement which closed in February 2024 and net proceeds of $12.2 million from our ATM program.
Current wording
During the three months ended March 31, 2024, net cash provided by financing activities was $57.5 million, which consists primarily of net proceeds of $46.9 million from the Private Placement which closed in February 2024 and net proceeds of $10.6 million from our ATM program.
Previous wording
As of September 30, 2024, we had approximately $144.8 million in cash, cash equivalents, and short-term investments. Based on our current operating plan, we believe that our existing cash, cash equivalents and short-term investments will be sufficient to fund our operations into the second half of 2026, including our current projections for PYX-201’s next phase of clinical development. However, we have based this estimate on assumptions that may prove to be wrong, and our operating plan may change as a result of many factors currently unknown to us. In addition, we could utilize our available capital resources sooner than we expect.
Current wording
As of March 31, 2025, we had approximately $105.4 million in cash, cash equivalents and short-term investments. We believe that our cash, cash equivalents and short-term investments as of March 31, 2025, will be sufficient to fund our operations into the second half of 2026. However, we have based this estimate on assumptions that may prove to be wrong, and our operating plan may change as a result of many factors currently unknown to us. In addition, we could utilize our available capital resources sooner than we expect.
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 $27.1 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%. 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 $26.4 million. The operating lease obligation is discussed in Note 10. Leases to our unaudited condensed consolidated financial statements included in Part I, Item 1 of this Quarterly Report on Form 10-Q for further information.
Previous wording
We did not have during the periods presented, and we do not currently have, any off-balance sheet arrangements, as defined in the rules and regulations of the Securities and Exchange Commission.
Current wording
We did not have during the years presented, and we do not currently have, any off-balance sheet arrangements, as defined in the rules and regulations of the Securities and Exchange Commission.
Rearranged previous paragraphs (3)
Previous report — wording carried elsewhere
The following table summarizes our research and development expenses for the nine months ended September 30, 2024 and 2023 (in thousands):
Previous report — wording carried elsewhere
The following table summarizes our general and administrative expenses for the nine months ended September 30, 2024 and 2023 (in thousands):
Previous report — wording carried elsewhere
During the nine months ended September 30, 2023, net cash provided by financing activities was $6.0 million, which consists primarily of net proceeds from our ATM program.