Pyxis Oncology, Inc.

Previous wording

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 wording

In April 2025, we presented 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:

Previous wording

In early January 2025, we initiated the dose expansion phase (Part 2) of the PYX-201-101 monotherapy study with a prioritized focus to confirm the preliminary efficacy signals in R/M HNSCC seen in Part 1. 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 wording

In early January 2025, we initiated the dose expansion phase (Part 2) of the PYX-201-101 monotherapy study with a prioritized focus to confirm the preliminary efficacy signals in R/M HNSCC seen in Part 1. We are enrolling and dosing patients for two monotherapy R/M HNSCC expansion cohorts. The Part 2 dose expansion phase includes the following two R/M HNSCC cohorts across sites in the United States (US), European Union (EU) and other countries:

Previous wording

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 wording

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 the fall of 2025.

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 $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.

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 $39.5 million and $20.6 million for the six months ended June 30, 2025 and 2024, respectively. As of June 30, 2025, we had an accumulated deficit of $403.1 million, net equity of $87.6 million, and cash, cash equivalents, restricted cash and short-term investments of $90.4 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

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 wording

The components of our cost of revenues are expenses directly attributable to revenues. During the three and six months ended June 30, 2025, we have not incurred any costs with respect to revenue.

Previous wording

Research and development expenses consist of costs incurred for our research activities, including our discovery efforts and research work to support clinical development, and the development of our programs. Research and development expenses are separated into program-specific costs and unallocated costs.

Current wording

Research and development expenses consist of costs incurred for our research work to support clinical development, and the development of our programs. Research and development expenses are separated into program-specific costs and unallocated costs.

Previous wording

facilities and other costs, which include allocated expenses for rent and maintenance of facilities, depreciation of leasehold improvements and equipment, laboratory supplies, third party cost for discovery research and the cost of consultants who assist with our research and development and costs related to contract manufacturing, but are not allocated to a specific program.

Current wording

facilities and other costs, which include allocated expenses for rent and maintenance of facilities, depreciation of leasehold improvements and equipment, laboratory supplies, third party cost for research and the cost of consultants who assist with our research and development and costs related to contract manufacturing, but are not allocated to a specific program.

Previous wording

We expect that our research and development expenses will increase substantially in connection with our ongoing and planned preclinical and clinical development activities in the near term and in the future. The successful development of our product candidate is highly uncertain. At this time, we cannot accurately estimate or know the nature, timing and costs of the efforts that will be necessary to complete the preclinical and clinical development of any of our product candidate and we may never succeed in obtaining regulatory approval for any of our product candidate.

Current wording

We expect that our research and development expenses will increase substantially in connection with our ongoing and planned preclinical and clinical development activities in the near term and in the future. The successful development of our product candidate is highly uncertain. At this time, we cannot accurately estimate or know the nature, timing and costs of the efforts that will be necessary to complete the preclinical and clinical development of our product candidate and we may never succeed in obtaining regulatory approval for our product candidate.

Previous wording

General and administrative expenses consist primarily of salaries and personnel-related costs, including stock-based compensation, and severance for our personnel in executive, legal, finance and accounting, human resources and other administrative functions. General and administrative expenses also include professional fees for auditing, tax, and legal services, as well as insurance, board of director compensation, consulting, other administrative expenses and facility costs not otherwise included in research and development expenses.

Current wording

General and administrative expenses consist primarily of salaries and personnel-related costs, including stock-based compensation, and severance for our personnel in executive, legal, finance and accounting, human resources, information technology and other administrative functions. General and administrative expenses also include professional fees for auditing, tax, and legal services, as well as insurance, board of director compensation, consulting, other administrative expenses and facility costs not otherwise included in research and development expenses.

Previous 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.

Current wording

Research and development expenses increased by $3.2 million, from $13.9 million for the three months ended June 30, 2024 to $17.1 million for the three months ended June 30, 2025.

Previous wording

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.

Current wording

PYX-106 program-specific research and development costs decreased by $1.1 million as we paused the clinical development of PYX-106-101 in December 2024.

Previous 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.

Current wording

Other income, net for the three months ended June 30, 2025 and 2024 was $1.7 million and $2.7 million, respectively. The decrease was primarily due to a decrease in interest and investment income as compared to the previous year.

Previous 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.

Current wording

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

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 .

Current wording

Micvotabart pelidotin program-specific research and development costs increased by $7.0 million, primarily due to a $3.9 million increase in contract manufacturing costs for the manufacturing of micvotabart pelidotin to support our ongoing clinical trials, a $1.8 million increase in clinical trial related expenses due to two clinical trials of MICVO (monotherapy and combo-therapy), and $1.3 million increase in translation work and other third party development costs.

Previous wording

Unallocated research and development increased by $2.0 million from $6.5 million for the three months ended March 31, 2024 to $8.5 million for the three months ended March 31, 2025. This increase was primarily due to severance cost of $1 million due to the reduction in workforce announced in March 2025 and increase in stock based compensation by $0.4 million.

Current wording

Unallocated research and development costs increased by $2.1 million from $13.0 million for the six months ended June 30, 2024 to $15.1 million for the six months ended June 30, 2025. This increase was primarily due to severance cost of $0.9 million due to the reduction in workforce implemented in March 2025 and increase in stock based compensation by $0.2 million.

Previous 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.

Current wording

General and administrative expenses decreased by $3.0 million, from $14.3 million for the six months ended June 30, 2024 to $11.3 million for the six months ended June 30, 2025. The decrease was primarily related to a decrease in stock based compensation by $0.8 million, lower professional and consultant fee by $0.5 million and lower corporate insurance, depreciation and amortization by $0.8 million.

Previous 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.

Current wording

We had cash, cash equivalents, restricted cash and short-term investments of $90.4 million as of June 30, 2025. For the three months ended June 30, 2025 and 2024, we had net losses of $18.4 million and $17.3 million, respectively. For the six months ended June 30, 2025 and 2024, we had net losses of $39.5 million and $20.6 million, respectively. As of June 30, 2025, we had an accumulated deficit of $403.1 million.

Previous 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.

Current 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 was 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.

Previous 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.

Current wording

During the six months ended June 30, 2024, net cash used in operating activities was $23.7 million, which consisted of our net loss of $20.6 million and a net change in our operating assets and liabilities of $9.5 million, partially offset by non-cash charges of $6.3 million. The non-cash charges of $6.3 million was primarily due to $7.2 million of stock-based compensation and $1.7 million of depreciation and amortization expense, offset by $2.9 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.

Previous wording

During the three months ended March 31, 2025, net cash provided by investing activities was $15.8 million, which consisted primarily of redemption of marketable debt securities of $67.2 million, partially offset by purchase of marketable debt securities of $51.4 million.

Current wording

During the six months ended June 30, 2025, net cash provided by investing activities was $31.1 million, which consisted primarily of redemption of marketable debt securities of $123.6 million, offset by purchases of marketable debt securities of $92.5 million.

Previous 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.

Current wording

During the six months ended June 30, 2024, net cash used in investing activities was $18.5 million, which consisted primarily of purchases of marketable debt securities of $132.1 million, offset by redemption of marketable debt securities of $113.8 million.

Previous 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.

Current wording

During the six months ended June 30, 2024, net cash provided by financing activities was $57.6 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 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.

Current wording

As of June 30, 2025, we had approximately $90.4 million in cash, cash equivalents, restricted cash and short-term investments. We believe that our cash, cash equivalents and short-term investments as of June 30, 2025, will be sufficient to fund our operations into the second half of 2026. However, we have based this estimate on assumptions that may prove to be wrong, and our operating plan may change as a result of many factors currently unknown to us. In addition, we could utilize our available capital resources sooner than we expect.

Previous wording

We lease an office and laboratory space in Boston, Massachusetts with lease payments that continue through December 31, 2032, and have scheduled rent increases each year of 3%. Additionally, we sublease 17,729 square feet of office and laboratory space in the building located at 321 Harrison Avenue, Boston, Massachusetts. The remaining contractual fixed lease payments, net of sublease payments and tenant improvement allowance, over the term of the lease aggregate to $26.4 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.

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 $26.1 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.