Whitehawk Therapeutics Reports Second Quarter 2026 Financial Results and Recent Highlights

On August 6, 2026 Whitehawk Therapeutics, Inc. (Nasdaq: WHWK), a clinical-stage oncology therapeutics company applying advanced technologies to established tumor biology to efficiently deliver improved antibody drug conjugate (ADC) cancer treatments, reported financial results for the quarter ended June 30, 2026, and provided recent corporate highlights.

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"The second quarter saw meaningful progress for our three assets. We continued enrollment in our Phase 1 studies for HWK-007 and HWK-016 and remain on track to initiate the Phase 1 trial for HWK-206 in Q3. We extended our anticipated runway into 2H 2028 following our recent upsized financing and we believe we are well positioned to support clinical execution against these programs," said Dave Lennon, PhD, President and Chief Executive Officer of Whitehawk Therapeutics. "While our focus, investment priorities and execution efforts remain on our existing portfolio, we also took steps to enhance the long-term potential of our Whitehawk platform. The Hangzhou DAC option agreement reflects our conviction in CPT113, while our collaboration with Biocytogen provides access to bispecific antibody formats. These selective opportunities support future programs and our ambition to deliver new ADC INDs in the next 12-24 months."

Q2 2026 and Recent Operational Highlights:

In May 2026, Whitehawk announced an $87.5M private placement equity financing. The financing included participation from existing investors including Avoro Capital, QVT, Coastlands Capital, KVP Capital, ADAR1 Capital Management, Acuta Capital Partners, StemPoint Capital LP, Invus, as well as members of Whitehawk’s executive team.

Continued to enroll patients into ongoing Phase 1 trials for HWK-007 and HWK-016.
HWK‑007 is being evaluated in patients with non-squamous, EGFR wild-type non-small cell lung cancer; platinum-resistant ovarian cancer; and endometrial cancer (NCT07444814). The study design was presented as a Trials-in-Progress poster at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2026.
HWK‑016 is being evaluated in patients with advanced ovarian and endometrial cancers (NCT07470853).

Entered into a new option agreement with Hangzhou DAC for access to CPT113 for use in up to five additional ADC programs. Whitehawk’s ADC platform leverages CPT113 as the core linker-payload technology, adding its own proprietary Carbon Bridge Cysteine Re-pairing (CBCR) bioconjugation process to support improved stability and therapeutic index. Per the terms of the option agreement, Whitehawk will select targets and source antibodies, while retaining global rights and full program control for the new ADC programs. Whitehawk anticipates submitting Investigational New Drug (IND) applications for multiple new programs over the next 12-24 months.

Presented real-world analysis confirming SEZ6 as a highly expressed, clinically relevant target for small-cell lung cancer (SCLC) and other neuroendocrine tumors at ASCO (Free ASCO Whitepaper) 2026. SEZ6 expression exceeds that of approved and emerging ADC targets in SCLC. SEZ6 expression is positively correlated with DLL3 expression across neuroendocrine carcinomas, indicating potential for combination with DLL3-targeted therapies.

Entered into a global collaboration with Biocytogen for bispecific antibody ADC (BsADC) development. Biocytogen will provide access to up to five bispecific antibodies using its proprietary RenLite platform, and Whitehawk will evaluate these in combination with its ADC linker-payload platform technologies. Whitehawk then has the option to advance any resulting BsADC candidates as part of its pipeline.
Second Quarter 2026 Financial Results:

Cash, cash equivalents and short-term investments as of June 30, 2026, were $190.0 million as compared to $145.7 million as of December 31, 2025. Cash is anticipated to fund operations into 2H 2028 based on current plans.

Research and development expenses were $12.9 million for the three months ended June 30, 2026, as compared to $48.8 million for the three months ended June 30, 2025. The prior year quarter included the $38.0 million up-front license fee paid to WuXi Biologics.

Net loss for the three months ended June 30, 2026, was $16.6 million as compared to $52.6 million for the three months ended June 30, 2025.
Anticipated Milestones:

HWK-206 – a Phase 1 study in small-cell lung cancer and neuroendocrine tumors is planned to initiate in Q3 2026.

HWK-007 and HWK-016 – ongoing recruitment into Phase 1 trials, with initial results expected in 1H 2027.

(Press release, Whitehawk Therapeutics, AUG 6, 2026, View Source [SID1234669832])

Caris Life Sciences, ECOG-ACRIN and NRG Oncology Study Demonstrates Multimodal AI Approach to Predict Late Distant Recurrence Risk in HR+ Early Breast Cancer

On August 6, 2026 Caris Life Sciences (Caris), a leading TechBio company, reported the publication of a study in Cancer Research Communications demonstrating the ability of a multimodal, multitask deep learning model to estimate late distant recurrence risk in hormone receptor-positive (HR+) early breast cancer.

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The study, titled "Development and Validation of a Multimodal-Multitask Deep Learning Approach for Estimating Late Distant Recurrence Risk in Hormone Receptor–Positive Early Breast Cancer," was conducted by a team of researchers from across the public and private sectors, including Caris Life Sciences and two leading cooperative research organizations, the NSABP Foundation/NRG Oncology and the ECOG-ACRIN Cancer Research Group (ECOG-ACRIN).

HR+ breast cancer represents approximately 70–80% of all breast cancer diagnoses and is associated with a prolonged risk of recurrence that can persist well beyond the initial five years of endocrine therapy, which is standard of care. Recurrence can happen at the original tumor site or further away in the body (distant recurrence). While extended endocrine therapy for an additional five years may reduce this risk, it comes with a trade-off of prolonged, challenging side effects. Identifying which patients are most likely to benefit remains a significant clinical challenge.

"This study underscores the transformative potential of artificial intelligence to extract clinically meaningful insights from routinely collected data," said George W. Sledge, MD, Chief Medical Officer. "By integrating AI-powered analysis of standard pathology images with clinical variables, this approach offers a promising path toward more precise risk stratification and may help inform individualized decisions regarding extended endocrine therapy for patients with hormone receptor-positive breast cancer."

The multimodal AI model integrates digitized hematoxylin and eosin (H&E) pathology images with clinicopathologic data to generate risk predictions for late distant recurrence in both node-positive and node-negative HR+ breast cancer. It was developed using banked tumor specimens contributed by 2,271 patients in the NSABP B-42 clinical trial. Through a public-private partnership with ECOG-ACRIN, it was externally validated in an independent cohort of 4,300 banked specimens from patients who participated in the landmark TAILORx study.

In the NSABP B-42 cohort, the study identified patients with substantially different outcomes, with a 10-year absolute distant recurrence risk difference of nearly 8% between high- and low-risk groups. External validation in the independent TAILORx cohort confirmed the model’s prognostic performance and demonstrated that it independently predicted late distant recurrence risk, even after accounting for established clinical risk factors and the Oncotype DX Recurrence Score.

Exploratory analyses further suggested that patients classified as high risk experienced greater absolute benefit from extended letrozole therapy compared to those classified as low risk, supporting the model’s potential utility in informing discussions regarding extended endocrine therapy.

Existing genomic assays provide valuable prognostic insights but may be limited by cost, accessibility, and turnaround time. The findings from this study suggest that AI-based analysis of routinely available pathology slides and clinical data could offer a scalable and accessible alternative or complement to existing tools.

By leveraging widely available diagnostic data, this approach may enable oncologists to better identify patients at elevated risk of late recurrence and support more personalized discussions regarding the benefits and risks of extended endocrine therapy.

In early May, Caris launched Caris MI Clarity, the first prognostic test designed to deliver insight into both early and late distant recurrence risk (years 0 through 5 and 5 through 15) for postmenopausal patients with HR+/HER2-negative, node-negative early-stage breast cancer at the time of diagnosis.

The new version includes decision support, not just prognosis. Adding information for chemotherapy decision support, identifying which patients are likely to benefit from chemo. Extended endocrine therapy decision support, informing treatment beyond the first five years. Late-window ordering in years 3 to 5, so recurrence risk can be reassessed during treatment, not only at diagnosis. MI Clarity unifies early and late distant risk into a single test, replacing two existing expensive tests with multi-week turnaround times.

(Press release, Caris Life Sciences, AUG 6, 2026, View Source [SID1234669831])

CellCarta Adds Tempus to CDx Commercialization Lab Network

On August 6, 2026 CellCarta, a global CRO laboratory supporting the biopharmaceutical industry, reported a strategic collaboration with Tempus AI, Inc. (NASDAQ: TEM). Under the agreement, CellCarta will include Tempus in its CDx Commercialization Lab Network as the network’s second commercial laboratory partner, strengthening oncology-focused companion diagnostics offerings to biopharma sponsors.

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Within the CellCarta network, the collaboration gives biopharma sponsors a more direct route from companion diagnostic development and regulatory approval to commercial use in U.S. oncology practice. CellCarta develops and validates the CDx, generates the analytical and clinical evidence package, supports regulatory submissions, and performs centralized immunohistochemistry (IHC) and tissue-based testing. For sponsors within the CellCarta CDx Commercialization Lab Network, Tempus will support provider test ordering through Tempus Hub, routing sample testing to CellCarta and transmitting results back to ordering healthcare providers.

Tempus joins Sonic Healthcare USA as the second member of CellCarta’s CDx Commercialization Lab Network, expanding the network’s specialized oncology capabilities alongside Sonic’s broad clinical and anatomic pathology reach across multiple disease areas. The Lab Network is part of CellCarta’s CDx Accelerator Model, a flexible and modular framework organized around four stages: Build, Validate, Launch, and Transfer. Sponsors can engage CellCarta at the stage that fits their program—from assay development and validation through clinical deployment and regulatory submission. Following approval, CellCarta activates its Commercialization Lab Network partners, such as Tempus and Sonic, to support commercial launch strategies.

"Tempus materially strengthens the oncology dimension of our commercialization model," said Ehab A. El-Gabry, MD, Chief Medical Officer and Head of Companion Diagnostics at CellCarta. "Sponsors can develop and validate a companion diagnostic at CellCarta, pursue a single-site approval strategy through our flexible and modular CDx Accelerator Model, and then use an established oncology diagnostics platform to support physician access and ordering. This connects regulatory execution with the realities of commercial launch."

"Biopharma sponsors should not have to choose between the speed and control of a centralized CDx strategy and a credible path to physicians and patients," said Christopher Ung, Chief Scientific Business Officer of CellCarta. "Adding Tempus to our network creates a powerful route into U.S. oncology practice. It gives sponsors a practical commercialization channel from a company that oncologists already know and use, while CellCarta maintains continuity from development and regulatory approval through testing."

CellCarta launched its CDx Commercialization Lab Network to address a common gap in companion diagnostic programs: securing regulatory approval does not by itself create the commercial infrastructure required for physicians to order a test and for patients to access it. The network connects CellCarta’s development, regulatory, and testing capabilities with commercial laboratory partners that have established provider relationships and ordering channels.

CellCarta intends to continue expanding the network by geography, therapeutic area, and commercial capability. The company’s objective is to give sponsors multiple pathways for launching centralized companion diagnostics while retaining flexibility for later expansion through additional laboratories or an IVD kitted solution.

(Press release, Tempus, AUG 6, 2026, View Source [SID1234669830])

CellCarta Adds Tempus to CDx Commercialization Lab Network

On August 6, 2026 CellCarta, a global CRO laboratory supporting the biopharmaceutical industry, reported a strategic collaboration with Tempus AI, Inc. (NASDAQ: TEM). Under the agreement, CellCarta will include Tempus in its CDx Commercialization Lab Network as the network’s second commercial laboratory partner, strengthening oncology-focused companion diagnostics offerings to biopharma sponsors.

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Within the CellCarta network, the collaboration gives biopharma sponsors a more direct route from companion diagnostic development and regulatory approval to commercial use in U.S. oncology practice. CellCarta develops and validates the CDx, generates the analytical and clinical evidence package, supports regulatory submissions, and performs centralized immunohistochemistry (IHC) and tissue-based testing. For sponsors within the CellCarta CDx Commercialization Lab Network, Tempus will support provider test ordering through Tempus Hub, routing sample testing to CellCarta and transmitting results back to ordering healthcare providers.

Tempus joins Sonic Healthcare USA as the second member of CellCarta’s CDx Commercialization Lab Network, expanding the network’s specialized oncology capabilities alongside Sonic’s broad clinical and anatomic pathology reach across multiple disease areas. The Lab Network is part of CellCarta’s CDx Accelerator Model, a flexible and modular framework organized around four stages: Build, Validate, Launch, and Transfer. Sponsors can engage CellCarta at the stage that fits their program—from assay development and validation through clinical deployment and regulatory submission. Following approval, CellCarta activates its Commercialization Lab Network partners, such as Tempus and Sonic, to support commercial launch strategies.

"Tempus materially strengthens the oncology dimension of our commercialization model," said Ehab A. El-Gabry, MD, Chief Medical Officer and Head of Companion Diagnostics at CellCarta. "Sponsors can develop and validate a companion diagnostic at CellCarta, pursue a single-site approval strategy through our flexible and modular CDx Accelerator Model, and then use an established oncology diagnostics platform to support physician access and ordering. This connects regulatory execution with the realities of commercial launch."

"Biopharma sponsors should not have to choose between the speed and control of a centralized CDx strategy and a credible path to physicians and patients," said Christopher Ung, Chief Scientific Business Officer of CellCarta. "Adding Tempus to our network creates a powerful route into U.S. oncology practice. It gives sponsors a practical commercialization channel from a company that oncologists already know and use, while CellCarta maintains continuity from development and regulatory approval through testing."

CellCarta launched its CDx Commercialization Lab Network to address a common gap in companion diagnostic programs: securing regulatory approval does not by itself create the commercial infrastructure required for physicians to order a test and for patients to access it. The network connects CellCarta’s development, regulatory, and testing capabilities with commercial laboratory partners that have established provider relationships and ordering channels.

CellCarta intends to continue expanding the network by geography, therapeutic area, and commercial capability. The company’s objective is to give sponsors multiple pathways for launching centralized companion diagnostics while retaining flexibility for later expansion through additional laboratories or an IVD kitted solution.

(Press release, Tempus, AUG 6, 2026, View Source [SID1234669830])

IN8bio Reports Second Quarter 2026 Financial Results and Recent Business Highlights

On August 6, 2026 IN8bio, Inc. (Nasdaq: INAB), a clinical-stage biopharmaceutical company developing innovative gamma-delta (γδ) T cell therapies and γδ T cell engagers (TCEs) for cancer and autoimmune diseases, reported financial results and business highlights for the second quarter ended June 30, 2026.

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"The second quarter marked an important period of scientific and clinical validation for γδ T cell therapeutics and IN8bio. Our γδ TCE platform is progressing, with INB-619 advancing into initial animal models. We are pleased to remain on track for reporting initial in vivo data this year," said William Ho, Chief Executive Officer and co-founder of IN8bio. "In addition, peer-reviewed and updated clinical data from our glioblastoma program continue to demonstrate a favorable safety profile and provide strong evidence that γδ T cells are clinically active and can be delivered safely to potentially improve patient outcomes. We remain focused on disciplined execution, as we continue to seek a regulatory pathway for our glioblastoma program, with the ultimate goal of bringing much needed treatment to patients."

Advancing Next-Generation γδ TCE Platform (INB-619)

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Continued advancement of proprietary INB-600 platform of novel γδ T cell engagers, designed to selectively eliminate targets such as CD19, potentially reducing toxicities including cytokine release syndrome (CRS) and infections, while expanding the therapeutic window compared with conventional CD3-targeting T cell engagers.

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Advancing INB-619, a CD19-targeting γδ T cell engager for oncology and autoimmune diseases, into IND-enabling studies following encouraging early preclinical data demonstrating complete B cell depletion, robust γδ T cell expansion, and minimal CRS-associated cytokine release, including IL-6 and TNF-α.
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Remain on track to report initial in vivo preclinical data in the second half of 2026.
Reported Clinical and Translational Advances for DeltEx DRI in Newly Diagnosed Glioblastoma

During the second quarter, IN8bio reported multiple clinical and scientific milestones supporting the clinical activity of γδ T cells and IN8bio’s DeltEx DRI platform:

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Published the first peer-reviewed clinical results of DeltEx DRI in newly diagnosed GBM in The Journal of Clinical Oncology. Among all patients treated, no dose-limiting toxicities (DLTs), CRS or immune effector cell-associated neurotoxicity syndrome (ICANS) were observed.
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Presented updated clinical data at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting demonstrating encouraging survival benefit in repeat-dose treated patients, with mPFS of 13.0 months versus 6.6 months for contemporaneously enrolled patients receiving only standard-of-care (SOC) and mOS exceeding 19.5+ months versus 13.2 months for SOC.
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Approximately 43% of repeat-dose patients remained alive at 24 months compared with 20% of SOC patients.
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Presented new translational data at the International Society for Cell & Gene Therapy (ISCT) and International Society for Cell & Gene Therapy (ISCT) and American Society of Gene & Cell Therapy (ASGCT) (Free ASGCT Whitepaper) Annual Meetings integrating artificial intelligence (AI), immunogenomics, histopathology, transcriptomics and spatial proteomics. Repeated DeltEx DRI dosing demonstrated preserved immune function during chemotherapy and positively remodeled the glioblastoma tumor microenvironment.
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Spatial proteomics analyses demonstrated an 18-fold increase in intratumoral CD8+ T cell density and a 90% reduction in immunosuppressive granulocytes, providing mechanistic support for the clinical activity observed with DeltEx DRI.

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IN8bio Chief Scientific Officer Lawrence Lamb co-authored a review in Nature Communications highlighting advances in γδ T cell engineering, γδ T cell engagers, CAR γδ T cells and combination immunotherapy strategies, reinforcing IN8bio’s scientific leadership in the rapidly expanding γδ T cell field.
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The publication highlights the potential of "off-the-shelf" γδ T cell therapies, driven by the cells’ lack of graft-versus-host disease (GvHD), and the growing clinical evidence supporting their application across hematologic malignancies and solid tumors, including GBM.
Upcoming Anticipated Milestones

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Report initial preclinical animal data for INB-619 in the second half of 2026.
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Report on FDA discussions regarding the potential regulatory pathways for the DeltEx DRI GBM program.
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INB-100 program clinical update at a scientific meeting in late 2026.
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Provide additional clinical and translational updates from the DeltEx DRI GBM program.
Second Quarter 2026 Financial Highlights

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Cash position: As of June 30, 2026, the Company had cash of $18.0 million, compared with $13.2 million, for the comparable prior year period.
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Research and Development (R&D) expenses: R&D expenses were $2.5 million for the three months ended June 30, 2026, compared with $2.5 million for the comparable prior year period. These amounts include non-cash items such as stock-based compensation (SBC) and depreciation.
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General and administrative (G&A) expenses: G&A expenses were $2.4 million for the three months ended June 30, 2026, compared with $2.7 million for the comparable prior year period. These amounts include non-cash items such as SBC and depreciation.
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Net loss: The Company reported a net loss of $4.8 million, or $0.25 per basic and diluted common share, for the three months ended June 30, 2026, compared with a net loss of $5.1 million, or $1.24 per basic and diluted common share, for the comparable prior year period.

(Press release, In8bio, AUG 6, 2026, View Source [SID1234669828])