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Whitehawk Therapeutics, Inc.

For the period ended Sep 30, 2026. Filed Nov 9, 2026.

View on SEC.gov

About this filing

A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.

Sep 30, 2026 · Filed Nov 9, 2026

WHWK$3.22+2.9%Stored close · as of Nov 9, 2026

What changed in Management’s Discussion and Analysis?

Read the current filing

Previous report: 10-Q

Period ended 2026-06-30; filed 2026-08-06.

0001193125-26-337933

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

Current report: 10-Q

Period ended 2026-09-30; filed 2026-11-09.

0001193125-26-453576

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

The 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 104 previous paragraphs and 111 current paragraphs.

63 unchanged; 37 reworded; 10 added; 3 removed; 1 previous and 1 current paragraphs rearranged.

Tables are not compared: 3 previous and 3 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 (10)

Current report

HWK-206 Update. In the third quarter of 2026, we filed the IND for HWK-206, our SEZ6-targeted ADC Therapy, which was cleared by the FDA. A Phase 1 trial is now actively recruiting and is initially evaluating activity in HWK-206 for the treatment of SCLC and NETs. In addition, we submitted an IND for HWK-206 in China in the third quarter of 2026 and we anticipate activating our first clinical sites in China in the first quarter of 2027. We expect initial data readout for the HWK-206 Phase 1 clinical trial by year-end 2027.

Current report

In October 2026, the FDA granted Fast Track Designation for HWK-206 for the treatment of patients with extensive-stage small cell lung cancer with disease progression on or after platinum-based chemotherapy.

Current report

In May 2026, we presented real world analysis as part of our collaboration with Tempus AI supporting the therapeutic potential of targeting SEZ6 with a next-generation ADC for the treatment of neuroendocrine tumors, including SCLC. These data were presented in a poster at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting, held May 29-June 2, 2026, in Chicago, Illinois. The data showed SEZ6 is highly expressed in SCLC and other tumors of neuroendocrine origin.

Current report

HWK-007 Update. In September 2026, we presented two real-world analyses as part of our collaboration with Tempus AI supporting PTK7 as a durable and clinically relevant ADC target in patients with pretreated, epidermal growth factor receptor ("EGFR") wild-type NSCLC. The data were presented at the IASLC 2026 World Conference on Lung Cancer (WCLC) hosted by the International Association for the Study of Lung Cancer, held September 12-15, 2026, in Seoul, Republic of Korea. In the first analysis, the data showed that PTK7 expression remained largely stable following standard-of-care immunotherapy, chemotherapy, chemoimmunotherapy and tyrosine kinase inhibitor treatment, suggesting that the target may remain available for PTK7-directed therapy after prior treatment. In the second analysis, the data demonstrated that PTK7 expression was not independently associated with real-world overall survival or progression-free survival in patients with advanced EGFR wild-type lung adenocarcinoma receiving second- or later-line therapy, supporting

Current report

PTK7 as a target-engagement biomarker rather than a marker of prognosis. We are currently evaluating HWK-007, our PTK7 targeted ADC Therapy, in an ongoing Phase 1 clinical trial in patients with non-squamous, EGFR wild-type NSCLC, platinum-resistant ovarian cancer and endometrial cancer.

Current report

HWK-016 Update. In October 2026, we presented two real-world analyses as part of our collaboration with Tempus AI supporting MUC16 as a durable therapeutic target and potential prognostic biomarker in ovarian cancer. These data were presented at the International Gynecologic Cancer Society (IGCS) Annual Global Meeting held October 1-3, 2026, in Montreal, Canada. MUC16 expression remained largely stable following platinum and non-platinum chemotherapy, bevacizumab-containing regimens, PARP inhibitors and mirvetuximab soravtansine, suggesting that the target may be suitable for MUC16-directed therapy after prior standard of care treatment and in combination with standard early-line platinum-based treatment. We are currently evaluating HWK‑016, our MUC16-targeted ADC Therapy, in an ongoing Phase 1 clinical trial in patients with advanced ovarian and endometrial cancers.

Current report

We anticipate submitting an investigational new drug application for new programs starting in the second half of 2027 in connection with our option agreement with Hangzhou DAC and collaboration agreement with Biocytogen.

Current report

New Member of the Board. On September 9, 2026, our board of directors appointed Vijay Iyengar, MD, as a new member of the board. Dr. Iyengar brings more than two decades of oncology experience building and scaling global businesses, leading strategic transactions across development-stage and commercial assets and guiding product portfolios from early development through commercialization. During his nine years in senior leadership roles at Incyte Corporation, he helped drive transformative change, including the launch of five brands across eight indications, the company's expansion into more than 20 countries and growth from approximately $1B to more than $4B in annual revenue. Prior to Incyte, Dr. Iyengar held senior leadership positions in oncology at Novartis. Earlier in his career, he was an Engagement Manager in the healthcare practice at McKinsey & Company.

Current report

Revenue and allowances described above were recorded through the FYARRO Divestiture date of March 25, 2025.

Current report

Research and development expenses for the three months ended September 30, 2026 and 2025 were $18.1 million and $14.3 million, respectively. The increase of $3.8 million was primarily driven by an increase of $7.4 million in external clinical development expense primarily related to HWK-007 and HWK-016 clinical studies and includes $3.2 million in development milestone expense to WuXi Biologics upon the acceptance of our IND for HWK-206, $1.4 million in personnel expenses, and $0.7 million in consulting expenses, offset by a $5.7 million decrease in clinical drug manufacturing.
Removed paragraphs (3)

Previous report

Data Presentations. In April 2026, we presented new preclinical data across our ADC Therapies at the American Association for Cancer Research (AACR) Annual Meeting 2026. The preclinical data showed a consistent preclinical profile for each of the ADC Therapies, characterized by potent tumor regressions, high plasma stability and favorable tolerability in non‑human primates, coupled with low systemic levels of free payload.

Previous report

In April 2026, we presented three posters from a real-world analysis supporting the therapeutic potential of targeting MUC16 with a next-generation ADC for the treatment of ovarian and endometrial cancers at the Society of Gynecologic Oncology (SGO) 2026 Annual Meeting on Women's Cancer. The data showed MUC16 as the highest-expressing ADC target in ovarian cancer, at least two-fold higher than other emerging targets, and showed MUC16 is highly and stably expressed in the most aggressive and most common subtypes of endometrial cancer.

Previous report

Research and development expenses for the six months ended June 30, 2026 and 2025 were $30.1 million and $57.6 million, respectively. The decrease of $27.5 million was primarily driven by a decrease of $28.6 million in external clinical development expense which included the $38.0 million up-front license fee paid to WuXi Biologics in 2025, $0.2 million in other expenses, offset by an increase of $0.9 million in consulting expenses and $0.4 million in clinical drug product manufacturing. For the six months ended June 30, 2026, external clinical development includes $5.3 million in milestone development expenses.
Reworded paragraphs (37)

Previous wording

References in the following discussion to “we,” “our,” “us,” or “Whitehawk” refer to Whitehawk Therapeutics, Inc and its subsidiary.

Current wording

References in the following discussion to “we,” “our,” “us,” or “Whitehawk” refer to Whitehawk Therapeutics, Inc. and its subsidiaries.

Previous wording

The U.S. Food and Drug Administration (“FDA”) cleared our investigational new drug (“IND”) applications for HWK-007, for the treatment of solid tumors, including non-small cell lung cancer (“NSCLC”) and ovarian cancer, and HWK-016, for the treatment of cancers of female origin, in the fourth quarter of 2025 and first quarter of 2026, respectively, and the Phase 1 trials for each asset are now actively recruiting. We expect data readouts in the first half of 2027 for each trial. We anticipate FDA clearance of our IND for HWK-206 for the treatment of small cell lung cancer ("SCLC") and neuroendocrine tumors (“NETs”) in mid-2026. With these three assets, we believe we have the ability to pursue multiple cancer indications with high potential in large addressable patient populations, including and beyond those indications currently expected to be targeted in our ongoing and upcoming Phase 1 trials.

Current wording

The U.S. Food and Drug Administration (“FDA”) cleared an investigational new drug application (“IND”) for each of HWK-007, for the treatment of solid tumors, including non-small cell lung cancer (“NSCLC”), ovarian cancer and endometrial cancer, HWK-016, for the treatment of advanced ovarian and endometrial cancers, and HWK-206 for the treatment of small cell lung cancer ("SCLC") and neuroendocrine tumors (“NETs”), in the fourth quarter of 2025, first quarter of 2026 and third quarter of 2026, respectively. The Phase 1 trials for each ADC Therapy are now actively recruiting. We expect data readouts with respect to the clinical trials of HWK-007 and HWK-016 in the first half of 2027 for each trial. With these three assets, we believe we have the ability to pursue multiple cancer indications with high potential in large addressable patient populations, including and beyond those indications currently expected to be targeted in our ongoing and upcoming Phase 1 trials.

Previous wording

For the periods presented and through the FYARRO Divestiture (as defined below), our lead drug product was FYARRO®(sirolimus protein-bound particles for injectable suspension (albumin-bound); nab-sirolimus). Nab-sirolimus is a potent inhibitor of the mTOR biological pathway with demonstrated anti-cancer activity in advanced malignant perivascular epithelioid cell tumor (“PEComa”), a rare cancer. We exclusively licensed FYARRO, previously called ABI-009, nab-sirolimus, from Abraxis BioScience, LLC, a wholly owned subsidiary of Celgene Corporation, which is a wholly owned subsidiary of Bristol-Myers Squibb Company (“BMS”). We refer to the development, production and commercial sale of FYARRO herein as the “FYARRO Business”. On February 22, 2022, we launched FYARRO in the United States for treatment of advanced malignant PEComa and recognized net product sales of $0 for the three and six months ended June 30, 2026, and $0 and $7.1 million for the three and six months ended June 30, 2025, respectively. See “Results of Operations” for further discussion of our results.

Current wording

For the periods presented and through the FYARRO Divestiture (as defined below), our lead drug product was FYARRO®(sirolimus protein-bound particles for injectable suspension (albumin-bound); nab-sirolimus). Nab-sirolimus is a potent inhibitor of the mTOR biological pathway with demonstrated anti-cancer activity in advanced malignant perivascular epithelioid cell tumor (“PEComa”), a rare cancer. We exclusively licensed FYARRO, previously called ABI-009, nab-sirolimus, from Abraxis BioScience, LLC, a wholly owned subsidiary of Celgene Corporation, which is a wholly owned subsidiary of Bristol-Myers Squibb Company (“BMS”). We refer to the development, production and commercial sale of FYARRO herein as the “FYARRO Business”. On February 22, 2022, we launched FYARRO in the United States for treatment of advanced malignant PEComa and recognized net product sales of $0 for the three and nine months ended September 30, 2026, and $0 and $7.1 million for the three and nine months ended September 30, 2025, respectively. See “Results of Operations” for further discussion of our results.

Previous wording

Former BMS License Agreement. We had exclusive rights for certain patents and a non-exclusive license for certain technology and know-how pertaining to ABI-009 (which we refer to as FYARRO) pursuant to an amended and restated license agreement, dated November 15, 2019, as amended August 31, 2021 (the “BMS License Agreement”) with Abraxis BioScience, LLC, a wholly owned subsidiary of Celgene Corporation, which is a wholly owned subsidiary of BMS. Under the BMS License Agreement, BMS is entitled to receive certain development milestone payments, royalties on net sales from licensed products under the agreement and any sublicense fees. Under the terms of this agreement, we recorded royalties on net product sales of $0 during the three months ended June 30, 2026 and 2025, respectively. For the six months ended June 30, 2026 and 2025, we recorded royalties on net product sales of $0 and $0.5 million, respectively. No development payments related to milestones were paid during the three and six months ended June 30, 2026 and 2025 under the agreement. See Note 7 to the financial statements for more information about the BMS License Agreement.

Current wording

Former BMS License Agreement. We had exclusive rights for certain patents and a non-exclusive license for certain technology and know-how pertaining to ABI-009 (which we refer to as FYARRO) pursuant to an amended and restated license agreement, dated November 15, 2019, as amended August 31, 2021 (the “BMS License Agreement”) with Abraxis BioScience, LLC, a wholly owned subsidiary of Celgene Corporation, which is a wholly owned subsidiary of BMS. Under the BMS License Agreement, BMS is entitled to receive certain development milestone payments, royalties on net sales from licensed products under the agreement and any sublicense fees. Under the terms of this agreement, we recorded royalties on net product sales of $0 during the three months ended September 30, 2026 and 2025, respectively. For the nine months ended September 30, 2026 and 2025, we recorded royalties on net product sales of $0 and $0.5 million, respectively. No development payments related to milestones were paid during the three and nine months ended

Previous wording

On December 19, 2024, we entered into the License Agreement with WuXi Biologics for exclusive rights to certain patents and know-how pertaining to WuXi Biologics’ preclinical ADC Therapies leveraging Hangzhou DAC linker-payload technology targeting each of MUC16, PTK7 and SEZ6. Under the License Agreement, we paid WuXi Biologics a non-refundable, partial upfront payment of $6.0 million on December 19, 2024 and we paid an additional non-refundable, upfront payment of $38.0 million on April 16, 2025, in each case, for the rights and licenses granted to us by WuXi Biologics. In accordance with the License Agreement, WuXi Biologics is eligible to receive from us (a) up to an aggregate of $265.0 million upon the achievement of certain development milestones, and (b) up to an aggregate of $540.0 million upon the achievement of certain commercial milestones, across all ADC Therapies programs. WuXi Biologics is also entitled to running royalties ranging from low-single-digit to upper-single-digit percentages of annual net sales of licensed products in the territory on a product-by-product and region-by-region basis from the first commercial sale of the applicable licensed product in a particular region until the date which is the later of (i) expiration of the last to expire valid claim of a license patent in such region covering the sale of such licensed product in such region or (ii) ten years after the first commercial sale of such licensed product in such region.

Current wording

In December 2024, we entered into the License Agreement with WuXi Biologics for exclusive rights to certain patents and know-how pertaining to WuXi Biologics’ preclinical ADC Therapies leveraging Hangzhou DAC linker-payload technology targeting each of MUC16, PTK7 and SEZ6. Under the License Agreement, we paid WuXi Biologics a non-refundable, partial upfront payment of $6.0 million in December 2024 and we paid an additional non-refundable, upfront payment of $38.0 million in April 2025, in each case, for the rights and licenses granted to us by WuXi Biologics. In accordance with the License Agreement, WuXi Biologics is eligible to receive from us (a) up to an aggregate of $265.0 million upon the achievement of certain development milestones, and (b) up to an aggregate of $540.0 million upon the achievement of certain commercial milestones, across all ADC Therapies programs. WuXi Biologics is also entitled to running royalties ranging from low-single-digit to upper-single-digit percentages of annual net sales of licensed products in the territory on a product-by-product and region-by-region basis from the first commercial sale of the applicable licensed product in a particular region until the date which is the later of (i) expiration of the last to expire valid claim of a license patent in such region covering the sale of such licensed product in such region or (ii) ten years after the first commercial sale of such licensed product in such region.

Previous wording

Pipeline Expansion. In May 2026, we entered into a new option agreement with Hangzhou DAC for access to CPT113, their core linker-payload technology, for use in up to five additional ADC programs. Per the terms of the option agreement, we will select targets and source antibodies, while retaining global rights and full program control for the new ADC programs. We anticipate submitting IND applications for multiple new programs over the next 12-24 months.

Current wording

Pipeline Update. In May 2026, we entered into a new option agreement with Hangzhou DAC for access to CPT113, their core linker-payload technology, for use in up to five additional ADC programs. Per the terms of the option agreement, we will select targets and source antibodies, while retaining global rights and full program control for the new ADC programs.

Previous wording

In addition, in June 2026, we entered into a global collaboration with Biocytogen to develop bispecific antibody-drug conjugates ("BsADC"). Biocytogen will provide access to up to five bispecific antibodies using its proprietary RenLite® platform, and we will evaluate these in combination with our ADC linker-payload platform technologies. We then have the option to advance any resulting BsADC candidates as part of our pipeline.

Current wording

In addition, in June 2026, we entered into a global collaboration with Biocytogen Boston Corp. ("Biocytogen") to develop bispecific antibody-drug conjugates ("BsADC"). Biocytogen will provide access to up to five bispecific antibodies using its proprietary RenLite® platform, and we will evaluate these in combination with our ADC linker-payload platform technologies. We then have the option to advance any resulting BsADC candidates as part of our pipeline.

Previous wording

Businesses have been and will continue to be impacted by a number of challenging global and national events and circumstances that continue to evolve, including the implementation of tariffs (and, as applicable, their subsequent actual or threatened modification or removal), recent turmoil in the global banking system, public health epidemics, such as the COVID-19 pandemic, extreme weather conditions, increased economic and regulatory uncertainty, inflation, rising interest rates, and geopolitical instability, including trade disputes and negotiations and the military conflicts in Ukraine, the Middle East and in other countries. The extent of the impact of these events and circumstances on our business, operations and development timelines and plans remains uncertain, and will depend on certain developments, including the duration and scope of the events and their impact on our development activities, third-party manufacturers, and other third parties with whom we do business, as well as its impact on regulatory authorities and our key scientific and management personnel. We have been and continue to actively monitor the potential impacts that these various events and circumstances may have on our business and we take steps, where warranted, to minimize any potential negative impacts on our business resulting from these events and circumstances.

Current wording

Businesses have been and will continue to be impacted by a number of challenging global and national events and circumstances that continue to evolve, including the implementation of tariffs (and, as applicable, their subsequent actual or threatened modification or removal), turmoil in the global banking system, public health epidemics, such as the COVID-19 pandemic, extreme weather conditions, increased economic and regulatory uncertainty, inflation, interest rates, and geopolitical instability, including trade disputes and negotiations and the military conflicts in Ukraine, the Middle East and in other countries. The extent of the impact of these events and circumstances on our business, operations and development timelines and plans remains uncertain, and will depend on certain developments, including the duration and scope of the events and their impact on our development activities, third-party manufacturers, and other third parties with whom we do business, as well as their impact on regulatory authorities and our key scientific and management personnel. We continue to actively monitor the potential impacts that these various events and circumstances may have on our business and we take steps, where warranted, to minimize any potential negative impacts on our business resulting from these events and circumstances.

Previous wording

We recorded a net gain on sale of $87.4 million for the FYARRO Divestiture in the first quarter of 2025.

Current wording

We recorded a net gain on sale of $87.3 million for the FYARRO Divestiture in the first quarter of 2025.

Previous wording

Commercial sale of FYARRO was launched on February 22, 2022, for the treatment of patients with advanced malignant PEComa. We recorded net product sales of $0 for the three months ended June 30, 2026 and 2025, respectively, and $0 and $7.1 million for the six months ended June 30, 2026 and 2025, respectively. As a result of the FYARRO Divestiture, we no longer commercialize FYARRO as of March 25, 2025. As the commercial sale of FYARRO constituted our sole source of revenue, we do not expect to generate further revenue for the foreseeable future.

Current wording

Commercial sale of FYARRO was launched in February 2022, for the treatment of patients with advanced malignant PEComa. We recorded net product sales of $0 for the three months ended September 30, 2026 and 2025, respectively, and $0 and $7.1 million for the nine months ended September 30, 2026 and 2025, respectively. As a result of the FYARRO Divestiture, we no longer commercialize FYARRO as of March 25, 2025. As the commercial sale of FYARRO constituted our sole source of revenue, we do not expect to generate further revenue for the foreseeable future.

Previous wording

We had built a cross-functional commercial team consisting of marketing, market access and commercial operations. Expenses related to our commercialization of FYARRO, including personnel expenses, sales support, and marketing are included in selling, general and administrative expenses for the six months ended June 30, 2025. We expect these expenses to decrease, as compared to prior periods, due to the FYARRO Divestiture which closed on March 25, 2025.

Current wording

We had built a cross-functional commercial team consisting of marketing, market access and commercial operations. Expenses related to our commercialization of FYARRO, including personnel expenses, sales support, and marketing are included in selling, general and administrative expenses for the nine months ended September 30, 2025. We expect these expenses to decrease, as compared to prior periods, due to the FYARRO Divestiture which closed on March 25, 2025.

Previous wording

We expect to increase our investment in research and development related to the ADC Therapies. We will continue to incur significant research and development and other expenses related to such ongoing operations. Under the License Agreement, we paid non-refundable license fees of $6.0 million and $38.0 million to WuXi Biologics in the fourth quarter of 2024 and the second quarter of 2025, respectively, plus a 6% VAT fee. Additionally, we recognized$5.3 million of development milestone-related expense for the six months ended June 30, 2026.

Current wording

We expect to increase our investment in research and development related to the ADC Therapies. We will continue to incur significant research and development and other expenses related to such ongoing operations. Under the License Agreement, we paid non-refundable license fees of $6.0 million and $38.0 million to WuXi Biologics in the fourth quarter of 2024 and the second quarter of 2025, respectively, plus a 6% VAT fee. Additionally, we recognized$8.5 million of development milestone-related expense for the nine months ended September 30, 2026.

Previous wording

As of June 30, 2026, we had $190.0 million of cash, cash equivalents and short-term investments. Based on our current plans, we believe our existing cash, cash equivalents and short-term investments will enable us to conduct our planned operations into the second half of 2028. As of June 30, 2026, we had an accumulated deficit of $392.1 million. Our net loss was $38.8 million and net income of $20.4 million for the six months ended June 30, 2026 and 2025, respectively. We have incurred net losses in each year since inception except for the six months ended June 30, 2025 as we incurred net income due to the sale of a business. These losses have resulted principally from costs incurred in connection with research and development activities, selling, general and administrative costs associated with our operations, costs associated with the Reverse Merger, the FYARRO Divestiture, and the in-licensing of the ADC Therapies. We expect to continue to incur significant expenses and operating losses for the foreseeable future due to the cost of research and development, including conducting preclinical and clinical trials of the ADC Therapies and identifying and designing product candidates and the regulatory approval process for any product candidates we may develop.

Current wording

As of September 30, 2026, we had $169.7 million of cash, cash equivalents and short-term investments. Based on our current plans, we believe our existing cash, cash equivalents and short-term investments will enable us to conduct our planned operations into the second half of 2028. As of September 30, 2026, we had an accumulated deficit of $413.3 million. Our net loss was $60.0 million and net income of $2.7 million for the nine months ended September 30, 2026 and 2025, respectively. We have incurred net losses in each year since inception except for the nine months ended September 30, 2025 as we incurred net income due to the sale of a business. These losses have resulted principally from costs incurred in connection with research and development activities, selling, general and administrative costs associated with our operations, costs associated with the Reverse Merger, the FYARRO Divestiture, and the in-licensing of the ADC Therapies. We expect to continue to incur significant expenses and operating losses for the foreseeable future due to the cost of research and development, including conducting preclinical and clinical trials of the ADC Therapies and identifying and designing product candidates and the regulatory approval process for any product candidates we may develop.

Previous wording

Other income (expense), net consists primarily of interest income earned on cash, cash equivalents and short-term investments, and foreign exchange loss for the three and six months ended June 30, 2026. During the three months ended June 30, 2025, other income includes interest income earned on cash, cash equivalents, and short-term investments, foreign exchange loss, and income received for billable services not part of our ordinary activities provided by our employees to KAKEN under a Transition Services Agreement ("TSA"). The TSA was entered into in connection with the sale of the business on March 25, 2025 and expired September 30, 2025. During the six months ended June 30, 2025, other income includes interest income earned on cash, cash equivalents, short-term investments, gain on sale of a business, foreign exchange loss, and income received for billable services not part of our ordinary activities provided by our employees to KAKEN under the TSA.

Current wording

Other income (expense), net consists primarily of interest income earned on cash, cash equivalents and short-term investments, and foreign exchange loss for the three and nine months ended September 30, 2026. During the three months ended September 30, 2025, other income includes interest income earned on cash, cash equivalents, and short-term investments, foreign exchange loss, and income received for billable services not part of our ordinary activities provided by our employees to KAKEN under a Transition Services Agreement ("TSA"). The TSA was entered into in connection with the sale of the business on March 25, 2025 and expired September 30, 2025. During the nine months ended September 30, 2025, other income includes interest income earned on cash, cash equivalents, short-term investments, gain on sale of a business, foreign exchange loss, and income received for billable services not part of our ordinary activities provided by our employees to KAKEN under the TSA.

Previous wording

During the three and six months ended June 30, 2026 and 2025, we recognized no income tax expense on the condensed consolidated statements of operations and comprehensive loss. Since our formation in 2011, we have not recorded any U.S. federal or state income tax benefits for the net losses we have incurred in each year or our earned tax credits, due to our uncertainty of realizing a benefit from those items.

Current wording

During the three and nine months ended September 30, 2026 and 2025, we recognized no income tax expense on the condensed consolidated statements of operations and comprehensive loss. Since our formation in 2011, we have not recorded any U.S. federal or state income tax benefits for the net losses we have incurred in each year or our earned tax credits, due to our uncertainty of realizing a benefit from those items.

Previous wording

Comparison of the Three and Six Months Ended June 30, 2026 and 2025

Current wording

Comparison of the Three and Nine Months Ended September 30, 2026 and 2025

Previous wording

Our product sales, net consist of sales of FYARRO. Product sales, net for the three months ended June 30, 2026 and 2025 were $0. Product sales, net for the six months ended June 30, 2026 and 2025, were $0 and $7.1 million, respectively. As a result of the FYARRO Divestiture, we no longer sell FYARRO as of March 25, 2025.

Current wording

Our product sales, net consist of sales of FYARRO. Product sales, net for the three months ended September 30, 2026 and 2025 were $0. Product sales, net for the nine months ended September 30, 2026 and 2025, were $0 and $7.1 million, respectively. As a result of the FYARRO Divestiture, we no longer sell FYARRO as of March 25, 2025.

Previous wording

Selling, general and administrative expenses for the three months ended June 30, 2026 and 2025, were $5.2 million and $5.9 million, respectively. The decrease of $0.7 million was primarily driven by a decrease of $0.7 million in personnel expenses and $0.3 million in consulting and insurance expenses, offset by an increase of $0.3 million in legal and other expenses.

Current wording

Selling, general and administrative expenses for the three months ended September 30, 2026 and 2025, were $4.8 million and $5.2 million, respectively. The decrease of $0.4 million was primarily driven by a decrease of $0.3 million in personnel expenses and $0.1 million in legal and other expenses.

Previous wording

Selling, general and administrative expenses for the six months ended June 30, 2026 and 2025 were $11.5 million and $18.8 million, respectively. The decrease of $7.3 million was primarily driven by a decrease of $4.7 million in consulting and insurance expenses, $1.3 million in legal and other expenses, $1.0 million in personnel expenses, and $0.3 million in commercial and marketing expenses.

Current wording

Selling, general and administrative expenses for the nine months ended September 30, 2026 and 2025 were $16.3 million and $24.0 million, respectively. The decrease of $7.7 million was primarily driven by a decrease of $4.8 million in consulting and insurance expenses, $1.4 million in legal and other expenses, $1.2 million in personnel expenses, and $0.3 million in commercial and marketing expenses.

Previous wording

Research and development expenses for the three months ended June 30, 2026 and 2025 were $12.9 million and $48.8 million, respectively. The decrease of $35.9 million was primarily driven by a decrease of $35.6 million in external clinical development expense which included the $38.0 million up-front license fee paid to WuXi Biologics in 2025 and a decrease of $1.6 million in clinical drug manufacturing, offset by an increase of $0.9 million in personnel expenses and $0.4 million in consulting expenses.

Current wording

Research and development expenses for the nine months ended September 30, 2026 and 2025 were $48.3 million and $71.9 million, respectively, a decrease of $23.6 million. The decrease was primarily attributable to a $21.2 million decrease in external clinical development expenses, reflecting the $38.0 million upfront license fee recognized in 2025 under the License Agreement with WuXi Biologics. External clinical development expenses in 2026 included $8.5 million of development milestone expenses. Additionally, the overall decrease also reflected decreases of $5.3 million in clinical drug manufacturing expenses and $0.1 million in other expenses, partially offset by increases of $1.6 million in consulting expenses and $1.4 million in personnel expenses.

Previous wording

Cost of goods sold was $0 for the three months ended June 30, 2026 and 2025. Cost of goods sold was $0 and $0.8 million for the six months ended June 30, 2026 and 2025, respectively, primarily reflecting royalties incurred on product sold. The decrease of cost of goods sold was due to the FYARRO Divestiture on March 25, 2025.

Current wording

Cost of goods sold was $0 for the three months ended September 30, 2026 and 2025. Cost of goods sold was $0 and $0.8 million for the nine months ended September 30, 2026 and 2025, respectively, primarily reflecting royalties incurred on product sold. The decrease of cost of goods sold was due to the FYARRO Divestiture on March 25, 2025.

Previous wording

Other income (expense), net for the three months ended June 30, 2026 and 2025 was $1.5 million and $2.1 million, respectively. The decrease of $0.6 million was primarily driven by a decrease in short-term investments held.

Current wording

Other income (expense), net for the three months ended September 30, 2026 and 2025 was $1.7 million and $1.8 million, respectively. The decrease of $0.1 million was primarily driven by a decrease in short-term investments held.

Previous wording

Other income (expense), net for the six months ended June 30, 2026 and 2025 was $2.8 million and $90.4 million, respectively. The decrease of $87.6 million was primarily driven by a gain on sale of a business related to the FYARRO Divestiture recognized during the six months ended June 30, 2025.

Current wording

Other income (expense), net for the nine months ended September 30, 2026 and 2025 was $4.5 million and $92.2 million, respectively. The decrease of $87.7 million was primarily driven by a gain on sale of a business related to the FYARRO Divestiture recognized during the nine months ended September 30, 2025.

Previous wording

As of June 30, 2026 we had $190.0 million of cash, cash equivalents and short-term investments. Based on our current plans, we believe our existing cash, cash equivalents and short-term investments will enable us to conduct our planned operations into the second half of 2028.

Current wording

As of September 30, 2026, we had $169.7 million of cash, cash equivalents and short-term investments. Based on our current plans, we believe our existing cash, cash equivalents and short-term investments will enable us to conduct our planned operations into the second half of 2028.

Previous wording

As of June 30, 2026, we had an accumulated deficit of $392.1 million. Our net loss was $38.8 million and net income of $20.4 million for the six months ended June 30, 2026 and 2025, respectively. We have incurred net losses in each year since inception except for the six months ended June 30, 2025 as we incurred net income due to the sale of a business. Losses have resulted principally from costs incurred in connection with research and development activities and selling, general and administrative costs associated with our operations. We expect to continue to incur significant expenses and operating losses for the foreseeable future due to the cost of research and development, including conducting preclinical and clinical trials of the ADC Therapies and identifying and designing product candidates and the regulatory approval process for any product candidates we may develop.

Current wording

As of September 30, 2026, we had an accumulated deficit of $413.3 million. Our net loss was $60.0 million and net income of $2.7 million for the nine months ended September 30, 2026 and 2025, respectively. We have incurred net losses in each year since inception except for the nine months ended September 30, 2025 as we incurred net income due to the sale of a business. Losses have resulted principally from costs incurred in connection with research and development activities and selling, general and administrative costs associated with our operations. We expect to continue to incur significant expenses and operating losses for the foreseeable future due to the cost of research and development, including conducting preclinical and clinical trials of the ADC Therapies and identifying and designing product candidates and the regulatory approval process for any product candidates we may develop.

Previous wording

On September 22, 2022, we entered into the purchase agreement for the 2022 PIPE Financing with the 2022 PIPE Investors for the sale of 3,373,526 shares of our common stock for a price of $12.50 per share and Pre-Funded Warrants (the "2022 Pre-funded Warrants") to purchase an aggregate of 2,426,493 shares of our common stock, at a purchase price of $12.4999 per 2022 Pre-Funded Warrant. The 2022 Pre-Funded Warrants are exercisable at an exercise price of $0.0001 and will be exercisable until exercised in full. The 2022 PIPE Financing closed on September 26, 2022. Aggregated net proceeds, after deducting certain expenses incurred of $0.3 million related to the issuance of the securities, were $72.2 million. As of June 30, 2026, 2,000,037 of the 2022 Pre-Funded Warrants are still outstanding.

Current wording

On September 22, 2022, we entered into the purchase agreement for the 2022 PIPE Financing with the 2022 PIPE Investors for the sale of 3,373,526 shares of our common stock for a price of $12.50 per share and Pre-Funded Warrants (the "2022 Pre-funded Warrants") to purchase an aggregate of 2,426,493 shares of our common stock, at a purchase price of $12.4999 per 2022 Pre-Funded Warrant. The 2022 Pre-Funded Warrants are exercisable at an exercise price of $0.0001 and will be exercisable until exercised in full. The 2022 PIPE Financing closed on September 26, 2022. Aggregated net proceeds, after deducting certain expenses incurred of $0.3 million related to the issuance of the securities, were $72.2 million. As of September 30, 2026, all of the 2022 Pre-Funded Warrants have been exercised.

Previous wording

On December 19, 2024, we entered into the Subscription Agreement (the "Subscription Agreement") with certain investors (the "2024 PIPE Investors"), pursuant to which we agreed to sell to the 2024 PIPE Investors (i) 21,592,000 shares of the our common stock, par value $0.0001 per share, at a purchase price of $2.40 per share, and (ii) pre-funded warrants to purchase an aggregate of 20,076,500 shares of our common stock (the "2024 Pre-Funded Warrants"), at a purchase price of $2.3999 per 2024 Pre-Funded Warrant, for aggregate net proceeds of $94.4 million, after deducting certain expenses incurred of $5.6 million related to the issuance of shares. The 2024 PIPE Financing closed on March 4, 2025. As of June 30, 2026, 16,866,574 of the 2024 Pre-Funded Warrants are still outstanding.

Current wording

On December 19, 2024, we entered into the Subscription Agreement (the "Subscription Agreement") with certain investors (the "2024 PIPE Investors"), pursuant to which we agreed to sell to the 2024 PIPE Investors (i) 21,592,000 shares of our common stock, par value $0.0001 per share, at a purchase price of $2.40 per share, and (ii) pre-funded warrants to purchase an aggregate of 20,076,500 shares of our common stock (the "2024 Pre-Funded Warrants"), at a purchase price of $2.3999 per 2024 Pre-Funded Warrant, for aggregate net proceeds of $94.4 million, after deducting certain expenses incurred of $5.6 million related to the issuance of shares. The 2024 PIPE Financing closed on March 4, 2025. As of September 30, 2026, 16,866,574 of the 2024 Pre-Funded Warrants were still outstanding.

Previous wording

On May 13, 2026, we entered into a securities purchase agreement for a private investment in public equity financing (the "2026 PIPE Financing") with certain investors (the "2026 PIPE Investors"), pursuant to which we agreed to sell to the 2026 PIPE Investors (i) 4,330,866 shares of our common stock, par value $0.0001 per share, at a purchase price of $3.92 per share, and (ii) pre-funded warrants to purchase an aggregate of 17,991,021 shares of our common stock (the "2026 Pre-Funded Warrants" and together with the 2022 Pre-Funded Warrants and 2024 Pre-Funded Warrants, the "Pre-Funded Warrants"), at a purchase price of $3.9199 per 2026 Pre-Funded Warrant, for aggregate net proceeds of $81.8 million, after deducting certain expenses incurred of $5.7 million related to the issuance of shares. As of June 30, 2026, all 17,991,021 of the 2026 Pre-Funded Warrants were outstanding.

Current wording

On May 13, 2026, we entered into a securities purchase agreement for a private investment in public equity financing (the "2026 PIPE Financing") with certain investors (the "2026 PIPE Investors"), pursuant to which we agreed to sell to the 2026 PIPE Investors (i) 4,330,866 shares of our common stock, par value $0.0001 per share, at a purchase price of $3.92 per share, and (ii) pre-funded warrants to purchase an aggregate of 17,991,021 shares of our common stock (the "2026 Pre-Funded Warrants" and together with the 2022 Pre-Funded Warrants and 2024 Pre-Funded Warrants, the "Pre-Funded Warrants"), at a purchase price of $3.9199 per 2026 Pre-Funded Warrant, for aggregate net proceeds of $81.7 million, after deducting certain expenses incurred of $5.8 million related to the issuance of shares. As of September 30, 2026, all 17,991,021 of the 2026 Pre-Funded Warrants were outstanding.

Previous wording

For the six months ended June 30, 2026, cash used in operating activities was $36.7 million and resulted from (i) our net loss of $38.8 million, (ii) a $0.9 million net negative impact on cash used due to changes in net operating assets and liabilities, and (iii) $3.0 million of non-cash adjustments, which were primarily related to share based compensation, depreciation, and discount amortization on short-term investments.

Current wording

For the nine months ended September 30, 2026, cash used in operating activities was $56.4 million and resulted from (i) our net loss of $60.0 million, (ii) a $0.8 million net negative impact on cash used due to changes in net operating assets and liabilities, and (iii) $4.4 million of non-cash adjustments, which were primarily related to share based compensation, depreciation, and discount amortization on short-term investments.

Previous wording

For the six months ended June 30, 2025, cash used in operating activities was $64.8 million and resulted from (i) our net income of $20.4 million, (ii) a $2.7 million net negative impact on cash used due to changes in net operating assets and liabilities, and (iii) $82.5 million of non-cash adjustments, which were primarily related to gain on sale of a business, share based compensation, discount amortization on short-term investments, lease expense, and depreciation.

Current wording

For the nine months ended September 30, 2025, cash used in operating activities was $80.2 million and resulted from (i) our net income of $2.7 million, (ii) a $2.5 million net negative impact on cash used due to changes in net operating assets and liabilities, and (iii) $80.3 million of non-cash adjustments, which were primarily related to gain on sale of a business, share based compensation, discount amortization on short-term investments, lease expense, and depreciation.

Previous wording

Cash provided by investing activities for the six months ended June 30, 2026 related to the maturities of short-term investments of $72.4 million, offset by purchases of short-term investments of $69.8 million.

Current wording

Cash provided by investing activities for the nine months ended September 30, 2026 related to the maturities of short-term investments of $111.6 million, offset by purchases of short-term investments of $105.4 million.

Previous wording

Cash provided by investing activities for the six months ended June 30, 2025 related to proceeds from the sale of business, maturities of short-term investments of $18.1 million, offset by purchases of short-term investments of $32.2 million and purchases of property and equipment of $0.6 million.

Current wording

Cash used in investing activities for the nine months ended September 30, 2025 related to proceeds from the sale of business, maturities of short-term investments of $20.1 million, offset by purchases of short-term investments of $125.8 million and purchases of property and equipment of $0.6 million.

Previous wording

For the six months ended June 30, 2026 cash provided by financing activities was $81.8 million and resulted from $87.5 million in proceeds received from the sale of common stock and pre-funded warrants as part of the 2026 PIPE Financing, offset by payment of 2026 PIPE Financing related transaction costs of $5.7 million.

Current wording

For the nine months ended September 30, 2026 cash provided by financing activities was $81.6 million and resulted from $87.5 million in proceeds received from the sale of common stock and pre-funded warrants as part of the 2026 PIPE Financing, offset by payment of 2026 PIPE Financing related transaction costs of $5.8 million.

Previous wording

For the six months ended June 30, 2025 cash provided by financing activities was $94.4 million and resulted from $100.0 million of proceeds received in the 2024 PIPE Financing (which closed in March 2025), offset by payment of 2024 PIPE Financing related transaction costs of $5.6 million.

Current wording

For the nine months ended September 30, 2025 cash provided by financing activities was $94.4 million and resulted from $100.0 million of proceeds received in the 2024 PIPE Financing (which closed in March 2025), offset by payment of 2024 PIPE Financing related transaction costs of $5.6 million.

Previous wording

In April 2022, we entered into a lease for 10,615 square feet of office space in Morristown, New Jersey. The term of the lease is seventy-three months unless terminated sooner. In connection with the FYARRO Divestiture, KAKEN assumed our sublease for the New Jersey office space, but we agreed to co-inhabit the office with KAKEN. We and KAKEN are currently in the process of extending the co-inhabitation arrangement upon the sublandlord's and landlord's consent.

Current wording

In April 2022, we entered into a lease for 10,615 square feet of office space in Morristown, New Jersey. The term of the lease is seventy-three months unless terminated sooner. In connection with the FYARRO Divestiture, KAKEN assumed our sublease for the New Jersey office space, but we agreed to co-inhabit the office with KAKEN. In August 2026, we received landlord and sublandlord consent and our sublease agreement with KAKEN for shared office space became effective. The agreement has a term of twenty-one months and expires in May 2028.

Previous wording

Rent expense is being recorded on a straight-line basis. Rent expense related to the New Jersey office space was $35 thousand and $34 thousand for the three months ended June 30, 2026 and 2025, respectively. Rent expense was $46 thousand and $0.1 million for the six months ended June 30, 2026 and 2025, respectively. See Note 6 to the condensed consolidated financial statements for additional details.

Current wording

Rent expense is being recorded on a straight-line basis. Rent expense related to the New Jersey office space was $41 thousand and $34 thousand for the three months ended September 30, 2026 and 2025, respectively. Rent expense was $0.1 million for the nine months ended September 30, 2026 and 2025. See Note 6 to the condensed consolidated financial statements for additional details.

Previous wording

On December 19, 2024, we entered into the License Agreement with WuXi Biologics for exclusive rights to certain patents and know-how pertaining to WuXi Biologics’ preclinical ADC Therapies leveraging Hangzhou DAC linker-payload technology targeting each of MUC16, PTK7 and SEZ6. Under the License Agreement, we paid $6.0 million and $38.0 million to WuXi Biologics in the fourth quarter of 2024 and the second quarter of 2025, respectively, plus a 6% VAT fee, in each case, for the rights and licenses granted to us by WuXi Biologics. Additionally, we paid$5.3 million of development milestone-related expense under the License Agreement in the first quarter of 2026.

Current wording

On December 19, 2024, we entered into the License Agreement with WuXi Biologics for exclusive rights to certain patents and know-how pertaining to WuXi Biologics’ preclinical ADC Therapies leveraging Hangzhou DAC linker-payload technology targeting each of MUC16, PTK7 and SEZ6. Under the License Agreement, we paid $6.0 million and $38.0 million to WuXi Biologics in the fourth quarter of 2024 and the second quarter of 2025, respectively, plus a 6% VAT fee, in each case, for the rights and licenses granted to us by WuXi Biologics. Additionally, we paid$8.5 million of development milestone-related expense under the License Agreement for the nine months ended September 30, 2026.
Rearranged current paragraphs (1)

Current report — wording carried from elsewhere

September 30, 2026 and 2025 under the agreement. See Note 7 to the financial statements for more information about the BMS License Agreement.
Rearranged previous paragraphs (1)

Previous report — wording carried elsewhere

PIPE Financing. On May 13, 2026, we entered into a securities purchase agreement for a private investment in public equity financing (the "2026 PIPE Financing") with certain investors (the "2026 PIPE Investors") for the sale of (i) 4,330,866 shares of our common stock, par value $0.0001 per share, at a purchase price of $3.92 per share, and (ii) 17,991,021 pre-funded warrants, at a purchase price of $3.9199 per pre-funded warrant, for aggregate net proceeds of $81.8 million.