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])

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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Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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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])

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])

On August 6, 2026 NextCure, Inc. (Nasdaq: NXTC), a clinical-stage biopharmaceutical company committed to discovering and developing novel therapies to treat cancer, reported a business update and announced second quarter 2026 financial results.

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"Following quarter end, we announced our proposed merger with Avere Therapeutics, together with Avere’s concurrent private financing expected to generate approximately $320 million in gross proceeds, and we are working toward a closing in the second half of 2026. In parallel, we are preserving capital in support of that closing. Our team continues to support the ongoing clinical programs and obligations to our partners, and opportunities to preserve value for our shareholders," said Michael Richman, President and CEO of NextCure.

Recent Business Highlights

● Announced a definitive merger agreement with Avere Therapeutics in an all-stock transaction. Upon closing, the combined company is expected to operate as Avere Therapeutics and trade on Nasdaq under the ticker symbol "AVRX". Existing NextCure stockholders are expected to receive contingent value rights ("CVRs") tied to certain legacy NextCure assets. Concurrently, Avere Therapeutics entered into a securities purchase agreement providing for a private financing expected to generate approximately $320 million in gross proceeds immediately prior to closing of the merger, subject to customary closing conditions.
● Entered into a Transition and Continuation Agreement with LigaChem Biosciences ("LigaChem") under which LigaChem has elected to continue the development of LNCB74 as the "Sole Developing Party" pursuant to the terms under the parties’ November 2022 Research Collaboration and Co-Development Agreement. NextCure, according to these agreements, remains eligible to receive future milestone and royalty payments for the development and commercialization of LNCB74.
● Advanced restructuring initiatives to reduce operating expenses, including facility footprint reductions and the sale of certain manufacturing, laboratory and facility-related assets in preparation for completion of the merger.
● Initiated efforts to preserve value of SIM0505 and our current clinical and pre-clinical assets for our shareholders.
Financial Results for the Quarter Ended June 30, 2026

● Cash, cash equivalents, and marketable securities as of June 30, 2026 were $20.1 million as compared to $41.8 million as of December 31, 2025. The decrease of $21.7 million was primarily due to cash used to fund operations of $23.1 million, partially offset by proceeds of $1.2 million from equity sales under our existing ATM program. In connection with the proposed merger with Avere Therapeutics and related restructuring activities, NextCure is focused on preserving capital, completing the proposed transaction and pursuing efforts to preserve value of our current clinical and pre-clinical assets.
● Research and development expenses were $7.4 million for the three months ended June 30, 2026, as compared to $24.1 million for the three months ended June 30, 2025. The decrease of $16.7 million was due to $17.0 million of license fees incurred in the prior year that did not occur in the current year.
● General and administrative expenses were $2.6 million for the three months ended June 30, 2026, as compared to $3.2 million for the three months ended June 30, 2025. The decrease of $0.6 million was primarily related to lower personnel related costs.
● Asset impairment costs associated with our recently announced restructuring initiatives to reduce our footprint and sell certain facility and laboratory assets totaled $5.1 million in the second quarter.
● Net loss was $14.9 million for the three months ended June 30, 2026, as compared to a net loss of $26.8 million for the three months ended June 30, 2025. The lower net loss for the three months ended June 30, 2026 as compared to the three months ended June 30, 2025 was driven by the lower research and development and general and administrative expenses mentioned above, partially offset by impairment costs of $5.1 million and lower other income, net, of $0.3 million.
About the Merger

On July 14, 2026 NextCure announced a definitive merger agreement with Avere Therapeutics, a privately held biotechnology company developing oral therapies for IL-23-driven inflammatory diseases, in an all-stock transaction. Concurrently with the merger agreement, Avere entered into a securities purchase agreement providing for a private financing expected to generate approximately $320 million in gross proceeds immediately prior to closing, subject to customary closing conditions. Upon closing, the combined company is expected to operate as Avere Therapeutics and trade on Nasdaq under the ticker symbol "AVRX." Following completion of the merger, the combined company will be led by Avere’s management team and governed by a board of directors constituted in accordance with the merger agreement. Existing NextCure stockholders are expected to retain an ownership interest in the combined company and receive CVRs tied to the potential future value of specified legacy NextCure

assets. The transaction is expected to close in the second half of 2026, subject to stockholder approval and other customary closing conditions.

About SIM0505

SIM0505 is an investigational antibody-drug conjugate (ADC) targeting CDH6 and incorporating a proprietary topoisomerase I inhibitor payload. On July 14, 2026, the Company announced it had informed all U.S. clinical trial sites to stop screening, consenting, and enrolling new patients and that it no longer intends to expand the clinical site footprint. The Company is seeking opportunities to preserve the value of SIM0505 for our shareholders.

About LNCB74

LNCB74 is a novel ADC directed to B7-H4, featuring a proprietary tumor-selective cleavable linker and MMAE payload. Following execution of a Transition and Continuation Agreement with LigaChem, LigaChem has elected to continue the program as Sole Developing Party. NextCure is providing transition support to facilitate the transfer of program-related activities and ongoing clinical trial operations. Pursuant to the November 2022 LigaChem Agreement, NextCure remains eligible to receive future development, regulatory and commercial milestone payments and royalties.

(Press release, NextCure, AUG 6, 2026, View Source [SID1234669824])

On August 6, 2026 Janux Therapeutics, Inc. (Nasdaq: JANX) (Janux), a clinical-stage biopharmaceutical company developing a broad pipeline of novel immunotherapies, reported financial results for the quarter ended June 30, 2026, and provided a business update.

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"During the second quarter we continued to execute across our clinical portfolio while preparing for multiple upcoming milestones," said David Campbell, Ph.D., President and Chief Executive Officer of Janux. "Enrollment continues across our prostate cancer programs, including JANX007 and JANX014, and we remain on track to initiate clinical development of JANX013 later this year. We also continue to make progress with JANX011 in healthy volunteers as we advance our autoimmune disease pipeline."

BUSINESS HIGHLIGHTS AND RECENT DEVELOPMENTS:

Clinical & Pipeline Progress

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JANX007 (PSMA-TRACTr) continues to enroll in its Phase 1b trial in metastatic castration-resistant prostate cancer (mCRPC), with ongoing dose optimization and expansion in taxane-naïve patients.
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An expansion cohort evaluating JANX007 in combination with darolutamide, an androgen receptor pathway inhibitor, is actively enrolling in taxane-naïve mCRPC.
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JANX014 (PSMA-TRACTr), a double-masked tumor-activated T cell engager, continues enrollment in its Phase 1 clinical study designed to evaluate safety, pharmacokinetics and preliminary antitumor activity.
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JANX011 (CD19-ARM) continues enrolling in its Phase 1 clinical trial in healthy volunteers.
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The Company continues to advance additional TRACTr, TRACIr and ARM programs for potential future development.

Upcoming Milestones

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Initial clinical data from the Phase 1 healthy volunteer study of JANX011 expected to be announced in the second half of 2026.
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Clinical initiation of JANX013, a PSMA-targeted CD28 costimulatory TRACIr, expected in the second half of 2026.

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Additional clinical data for JANX007 expected to be announced at a future medical congress in the first half of 2027.

SECOND QUARTER 2026 FINANCIAL RESULTS:

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Cash and cash equivalents and short-term investments: As of June 30, 2026, Janux reported cash and cash equivalents and short-term investments of $970.9 million, compared to $966.6 million on December 31, 2025.
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Research and development expenses: Research and development expenses were $31.0 million for the quarter ended June 30, 2026, compared to $34.7 million for the comparable period in 2025.
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General and administrative expenses: General and administrative expenses were $11.0 million for the quarter ended June 30, 2026, compared to $10.5 million for the comparable period in 2025.
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Net loss: Net loss was $22.0 million for the quarter ended June 30, 2026, compared to $33.9 million for the comparable period in 2025.

(Press release, Janux Therapeutics, AUG 6, 2026, View Source [SID1234669822])