Pyxis Oncology, Inc.

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 are actively evaluating both of these approaches to optimize MICVO’s benefit-risk profile.

Current 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.

Previous wording

We believe the totality of our preliminary clinical and preclinical data supports continued clinical development of both MICVO monotherapy expansion and combination therapy trials.

Current wording

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 wording

The dose expansion phase of our PYX-201-101 monotherapy study is ongoing with the objective of further evaluating the preliminary safety, efficacy and durability signals observed with MICVO in R/M HNSCC at the 5.4mg/kg IV Q3W dose. In the first quarter of 2026, we completed target enrollment of approximately 40 patients across two 2L+ R/M HNSCC cohorts in the Phase 1 monotherapy dose expansion study of MICVO and are actively treating patients in both the cohorts. The dose expansion phase includes the following R/M HNSCC cohorts across sites in the United States (US), European Union (EU) and other countries:

Current wording

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 wording

The mid-year 2026 update will focus on participants treated at 5.4 mg/kg IV Q3W with a dose equivalent to or below a dose cap, and will include detailed analyses of the impact of dose capping on safety, tolerability, and efficacy. Dose capping and AIBW are both well-established approaches to modified weight-based dosing and have demonstrated improved tolerability without sacrificing clinical activity in studies of other ADCs. In December 2025, we implemented a dose cap for higher body weight patients. Based on internal PK simulation modeling indicating that MICVO exposure with dose capping and AIBW dosing are comparable, dose capping was prioritized for its operational simplicity and ease of implementation. A protocol amendment permitting AIBW dosing has since been approved, and AIBW dosing has begun in ongoing clinical studies. AIBW will be selected as a go-forward dose strategy only if it offers a superior profile to dose capping.

Current wording

Dose capping and AIBW are both well-established approaches to modified weight-based dosing and have demonstrated improved tolerability without sacrificing clinical activity in studies of other ADCs. In December 2025, we implemented a dose cap for higher body weight patients. Based on internal PK simulation modeling indicating that MICVO exposure with dose capping and AIBW dosing are comparable, dose capping was prioritized for its operational simplicity and ease of implementation. A protocol amendment permitting AIBW dosing has since been approved, and AIBW dosing has begun in ongoing clinical studies. AIBW will be selected as a go-forward dose strategy only if it offers a superior profile to dose capping.

Previous wording

During the fourth quarter of 2025, we obtained feedback and alignment from the U.S. Food and Drug Administration (FDA) regarding the clinical trial design for a planned pivotal monotherapy study in 2L+ R/M HNSCC.

Current wording

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 wording

We are on track to report updated data in the second half of 2026 from the ongoing PYX-201-102 Phase 1/2 dose escalation study evaluating MICVO in combination with KEYTRUDA®, with the update focused on patients with 1L R/M HNSCC.

Current 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.

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 $23.3 million and $21.2 million for the three months ended March 31, 2026 and 2025, respectively. As of March 31, 2026, we had an accumulated deficit of $466.4 million, net equity of $31.3 million, and cash, cash equivalents and marketable debt securities of $41.0 million. We expect to continue to incur significant expenses and operating losses for the foreseeable future. We expect that our expenses and capital expenditures will increase substantially in connection with our ongoing activities. Our operations to date have been financed primarily through sales of convertible preferred stock and sale of equity securities and additional funding will be necessary to fund future clinical and preclinical activities.

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 $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.

Previous wording

The components of our cost of revenues are expenses directly attributable to revenues. During the three months ended March 31, 2026 and 2025, the Company has not incurred any costs with respect to revenue.

Current wording

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 wording

PYX-106 program-specific research and development costs decreased by $0.5 million, reflecting lower program-related expenses following the pause in clinical development of PYX-106-101 in December 2024.

Current 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.

Previous wording

General and administrative expenses decreased by $1.5 million, from $5.9 million for the three months ended March 31, 2025 to $4.4 million for the three months ended March 31, 2026. This decrease was primarily attributable to a $1.8 million reduction in personnel-related expenses, mainly due to lower stock-based compensation.

Current 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.

Previous wording

Other income, net for the three months ended March 31, 2026 and 2025 was $1.1 million and $1.8 million, respectively. The decrease of $0.7 million was primarily due to lower interest and investment income, partially offset by higher sublease income.

Current 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.

Previous wording

MICVO program-specific research and development costs increased by $5.5 million, primarily reflecting a $4.4 million increase in clinical trial-related expenses due to an increased number of patients dosed in the MICVO monotherapy and combination therapy trials, as well as an $0.8 million increase in preclinical studies.

Current 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.

Previous wording

Unallocated research and development costs decreased by $1.8 million due to decreased severance expense of $1.0 million, decreased employee recruitment costs of $0.4 million, and a reduction in other research and development support costs of $0.4 million.

Current 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.

Previous wording

We had cash, cash equivalents and marketable debt securities of $41.0 million as of March 31, 2026. For the three months ended March 31, 2026 and 2025, we had net losses of $23.3 million and $21.2 million, respectively. As of March 31, 2026, we had an accumulated deficit of $466.4 million.

Current 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.

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 months ended March 31, 2026 and 2025, we did not sell any shares under the ATM program. As of March 31, 2026, we had $150.0 million of remaining capacity available under the ATM facility.

Current wording

On November 26, 2025, we filed a registration statement on Form S-3 with the SEC for the issuance of common stock, preferred stock, warrants, debt securities, rights and units with an aggregate offering price of up to $350.0 million. On December 9, 2025, the registration statement was declared effective by the SEC. The registration statement includes an at-the-market (“ATM”) offering program for the sale of up to $150.0 million of shares of our common stock. During the three 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.

Previous wording

Until such time, if ever, we can generate substantial product revenues, we expect to finance our operations through a combination of equity offerings, debt financings, collaborations, strategic alliances and marketing, distribution or licensing arrangements. To the extent that we raise additional capital through the sale of equity or convertible debt securities, your ownership interest will be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect your rights as a common stockholder. Debt financing and preferred equity financing, if available, may involve agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making acquisitions, engaging in acquisition, merger or collaboration transactions, selling or licensing our assets, making capital expenditures, redeeming our stock, making certain investments or declaring dividends.

Current wording

Until such time, if ever, we can generate substantial product revenues, we expect to continue to finance our operations through a combination of equity offerings, debt financings, collaborations, strategic alliances and marketing, distribution or licensing arrangements. To the extent that we raise additional capital through the sale of equity or convertible debt securities, your ownership interest will be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect your rights as a common stockholder. Debt financing and preferred equity financing, if available, may involve agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making acquisitions, engaging in acquisition, merger or collaboration transactions, selling or licensing our assets, making capital expenditures, redeeming our stock, making certain investments or declaring dividends.

Previous wording

During the three months ended March 31, 2026, net cash used in operating activities was $26.0 million, which consisted of our net loss of $23.3 million and a net change in our operating assets and liabilities of $4.4 million, partially offset by non-cash charges of $1.7 million. Non-cash charges of $1.7 million primarily consisted of $1.2 million of stock-based compensation, $0.5 million of depreciation and amortization expense, and $0.2 million of non-cash operating lease expense, partially offset by $0.2 million of accretion of discounts on marketable debt securities. The net change in operating assets and liabilities was primarily driven by a $5.9 million decrease in accounts payable, a $1.2 million increase in accrued expenses and other current liabilities, and a $0.7 million increase in prepaid expenses and other current assets, partially offset by other working capital changes, reflecting the timing of vendor payments and ongoing clinical trial activities.

Current 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.

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 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.

Previous wording

During the three months ended March 31, 2026, net cash provided by investing activities was $16.4 million, which consisted primarily of $27.4 million of maturities and redemptions of marketable debt securities, partially offset by $11.0 million of purchases of marketable debt securities.

Current 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.

Previous wording

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

Current 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.

Previous wording

During the three months ended March 31, 2026, net cash used in financing activities was $0.03 million, which primarily related to tax withholding payments associated with the net settlement of restricted stock awards.

Current 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.

Previous wording

As of March 31, 2026, we had approximately $41.0 million in cash, cash equivalents and marketable debt securities. We believe that our cash, cash equivalents and marketable debt securities as of March 31, 2026 will be sufficient to fund our operations into the fourth quarter of 2026. However, we have based this estimate on assumptions that may prove to be wrong, and our operating plan may change as a result of many factors currently unknown to us. In addition, we could utilize our available capital resources sooner than we expect.

Current 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.

Previous wording

Our future cash flows are dependent on key variables such as our ability to secure additional sources of funding in the form of public or private financing of equity or debt or collaboration agreements or a combination of these. While we remain optimistic to obtain additional funding, the current available cash, cash equivalents and marketable debt securities, will not be sufficient to fund our operations over the next 12 months from the date of this Quarterly Report on Form 10-Q. This condition raises substantial doubt about our ability to continue as a going concern for one year from the date the unaudited condensed consolidated financial statements are issued.

Current wording

Our future cash flows are dependent on key variables such as our ability to secure additional sources of funding in the form of public or private financing of equity or debt or collaboration agreements or a combination of these. While we remain optimistic to obtain additional funding, the current available cash, cash equivalents and marketable debt securities, 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.

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 $24.7 million. The operating lease obligation is discussed in Note 10. Leases to our unaudited condensed consolidated financial statements included in Part I, Item 1 of this Quarterly Report on Form 10-Q for further information.

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 $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.