On August 8, 2025 Shanghai Junshi Biosciences Co., Ltd (Junshi Biosciences, HKEX: 1877; SSE: 688180), a leading innovation-driven biopharmaceutical company dedicated to the discovery, development, and commercialization of novel therapies, reported that the supplemental new drug application ("sNDA") for toripalimab (trade name: TUOYI) in combination with disitamab vedotin, an antibody-drug conjugate ("ADC") developed by RemeGen Co., Ltd. as the treatment of HER2-expressing (HER2 expression is defined as a HER2 immunohistochemistry test result of 1+, 2+, or 3+) locally advanced or metastatic urothelial carcinoma ("UC") has been accepted by the National Medical Products Administration ("NMPA") (Press release, Shanghai Junshi Bioscience, AUG 8, 2025, View Source [SID1234656128]). This is toripalimab’s 13th application for marketing submitted in the Chinese mainland.

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UC is one of the ten most prevalent malignant tumors in the world, and in China, its incidence and mortality rates continue rising annually. According to the latest data from the National Cancer Center, in 2022, the number of new cases of UC in China reached 92,900, and the number of deaths reached over 40,000. UC is a serious threat to the life and health of patients, and there are huge unmet clinical needs.

In 2021, toripalimab was approved for the second-line and above treatment of advanced UC, becoming the first immunotherapy drug approved for non-selective, population-based indications of advanced UC in China. Over the past 5 years, the emergence of PD-(L)1 monoclonal antibodies and novel ADCs has been continuously reshaping the treatment landscape for advanced UC. Compared with conventional chemotherapy, novel therapies have demonstrated significant improvements in terms of survival benefit and tolerability, leading to more diverse and precise treatment options for patients.

The sNDA is based on results from the RC48-C016 study (NCT05302284), a multi-center, randomized, open-label and controlled phase 3 clinical trial, which evaluated the efficacy and safety of toripalimab in combination with disitamab vedotin versus gemcitabine in combination with cisplatin/carboplatin in systemic-treatment-naive patients with HER2 (human epidermal growth factor receptor 2)-expressing locally advanced or metastatic UC. The study was conducted in 74 clinical centers across China with Professor Jun GUO from Beijing Cancer Hospital and Professor Aiping ZHOU from the Cancer Hospital of the Chinese Academy of Medical Sciences as the principal investigators.

On August 8, 2025 Calidi Biotherapeutics Inc. (NYSE American: CLDI) ("Calidi"), a clinical-stage biotechnology company pioneering the development of targeted therapies with the potential to deliver genetic medicines to distal sites of disease, reported its second quarter 2025 operating and financial results and reviewed recent business highlights (Press release, Calidi Biotherapeutics, AUG 8, 2025, View Source [SID1234655129]).

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"We are extremely excited about the progress at Calidi," said Eric Poma, PhD, CEO of Calidi Biotherapeutics. "We believe our RedTail platform, with its ability to protect virus from immune clearance and induce tumor lysis and the delivery of potent therapeutic genetic medicines to metastatic sites through systemic administration, will be a substantial breakthrough in the field of oncolytic viruses and tumor-targeted gene therapies. We look forward to leveraging our scientific, operational and capital markets experience to continue building on Calidi’s strong platforms."

Second Quarter 2025 and Recent Corporate Developments

Presented new preclinical data surrounding CLD-401, the first lead compound from Calidi’s proprietary RedTail platform, at the American Society for Clinical Oncology (ASCO) (Free ASCO Whitepaper) on May 30th in Chicago, IL., demonstrating enhanced biological efficacy in syngeneic tumor models through the delivery of IL15 superagonist to metastatic tumors sites after systemic administration. Calidi also demonstrated the engineered expression of CD55 on the enveloped virus, allowing the virus to avoid immune clearance and enabling systemic administration. The systemic administration of the CD55-expressing enveloped virus allows Calidi to target metastatic disease patients with high unmet need.
Raised $4.6 million in gross proceeds from a warrant inducement offering with existing investors despite a challenging financing environment for the biotech industry, increasing the total gross proceeds raised in all offerings in 2025 to $15.7 million.
Granted Fast Track Designation to CLD-201 by the U.S. Food and Drug Administration (FDA) for the treatment of patients with soft tissue sarcoma. CLD-201 is a first-in-class stem cell loaded intratumoral oncolytic viral therapy that has demonstrated significant advantages over current intratumoral oncolytic viral approaches. An IND for a Phase 1 study was successfully opened for CLD-201 in Q1-2025.

Second Quarter 2025 Financial Results

The company reported a net loss attributable to common stockholders of $5.7 million, or $1.99 per share, for the three months ended June 30, 2025, compared to a net loss attributable to common stockholders of $7.4 million, or $16.75 per share, for the same period in 2024.

Research and development expenses were $2.6 million for the three months ended June 30, 2025, compared to $2.2 million for the comparable period in 2024.

General and administrative expenses were $3.1 million for the three months ended June 30, 2025, compared to $3.6 million for the comparable period in 2024.

The company had approximately $5.3 million in cash and $0.1 million in restricted cash as of June 30, 2025, compared to $9.6 million in cash and $0.2 million in restricted cash as of December 31, 2024.

On August 8, 2025 Tempus AI, Inc. (NASDAQ: TEM), a technology company leading the adoption of AI to advance precision medicine and patient care, reported financial results for the quarter ended June 30, 2025 (Press release, Tempus, AUG 8, 2025, View Source [SID1234655044]).

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Revenue increased 89.6% year-over-year to $314.6 million in the second quarter
Genomics revenue increased 115.3% year-over-year to $241.8 million on accelerating year-over-year volume growth in Oncology (26%) and Hereditary (32%) testing
Data and services revenue increased 35.7% year-over-year to $72.8 million, led by Insights (data licensing), which grew 40.7% year-over-year
Quarterly gross profit was $195.0 million, a 158.3% year-over-year increase
Issued $750 million of 0.75% convertible senior notes that will drive significant interest expense and cash savings
Increasing full year 2025 revenue guidance to $1.26 billion, along with positive adjusted EBITDA of $5 million, a $110 million improvement over 2024
"The business is performing well with revenues and margins growing faster than expected, contributing to our continued improvement in adjusted EBITDA on a year-over-year basis," said Eric Lefkofsky, Founder and CEO of Tempus. "We saw significant re-acceleration of our clinical volumes which grew 30% in the quarter, as we delivered more than 212,000 NGS tests. Combined with our continued leadership in AI and progress toward building the largest foundation model in oncology, ‘we’re hitting our stride’ as we approach our 10th anniversary."

Second Quarter Summary Results

Quarterly revenue increased 89.6% year-over-year to $314.6 million.
Genomics contributed $241.8 million in revenue in the quarter, growing 115.3% compared to the second quarter of 2024.
Oncology testing (Tempus genomics) delivered $133.2 million of revenue, up 32.9% year-over-year with approximately 26% volume growth versus 20% last quarter.
Hereditary testing (Ambry genetics) contributed $97.3 million of revenue, up 33.6% year-over-year on a pro forma basis1 with approximately 32% volume growth.
Revenue from Data and services totaled $72.8 million in the second quarter, delivering 35.7% growth versus the second quarter of 2024, led by Insights (data licensing), which grew 40.7% year-over-year.
Generated $195.0 million in quarterly gross profit, reflecting a 158.3% increase year-over-year.
Improvement in reported net loss of ($42.8 million) in the second quarter of 2025, including fair value gains of $37.8 million related to our marketable equity securities and stock compensation and employer payroll tax related to stock-based compensation of ($24.3) million, compared to a net loss of ($552.2 million) in the second quarter of 2024.
Adjusted EBITDA of ($5.6 million) in the second quarter of 2025 compared to ($31.2 million) in the second quarter of 2024, an improvement of $25.6 million year-over-year.
1

The pro forma amounts have been calculated after applying the Company’s accounting policies

Second Quarter and Recent Operational Highlights

Strengthened Financial Flexibility: Just after quarter end, we completed an upsized offering of $750 million 0.75% convertible senior notes, enhancing our balance sheet and allowing us to replace a portion of the existing term loan with a significantly lower interest debt instrument. We also ended the quarter with $293.0 million in cash and marketable securities, an improvement of ~$70 million over last quarter.
Expanded AI-Powered Clinical Tools: Extended Tempus Next care pathway intelligence platform into breast cancer, furthering AI-driven decision support across oncology. In addition, Tempus One, our generative AI clinical assistant, was integrated into leading electronic health record (EHR) systems to enhance physician workflows and point-of-care insights.
Advanced MRD and monitoring: Introduced Tempus xM for treatment and response monitoring (TRM), a liquid biopsy assay designed to monitor immunotherapy response in patients with advanced solid tumors, providing clinicians with actionable, real-time insights. We also expanded our exclusive collaboration with Personalis to include colorectal cancer as the fourth indication under the NeXT Personal MRD commercial partnership.
Reached new database milestone: Through more than 4,500 integrations, we are now connected to more than 40 million clinical patient records, with ~9 million de-identified and ingested, spanning ~1.1 billion healthcare documents, a significant percentage of which are connected to the ~4 million samples we have sequenced. As a result, our database now stands at >350 petabytes of connected clinical and molecular data.
Approaching 10-Year anniversary: As we near Tempus’ 10-year anniversary, we’re reflecting on a decade of innovation and collaboration which now spans more than 2,000 publications including ~700 peer reviewed articles and ~180 oral presentations.

On August 8, 2025 RemeGen Co., Ltd. (688331.SH/09995.HK) reported clearance of IND application by Food and Drug Administration (FDA) for phase II clinical trials for its independently-developed bispecific antibody, RC148, for the treatment of multiple advanced malignant solid tumors in the US (Press release, RemeGen, AUG 8, 2025, View Source [SID1234655043]).

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RC148 is a PD-1 and VEGF-targeting bispecific antibody, an innovative molecule developed by RemeGen using its bispecific antibody technology platform. Currently, the clinical trials of RC148 as monotherapy and combination therapy for the treatment of advanced solid tumor are proceeding in China.

The clearance of IND application by the FDA is a significant milestone for RC148 which should expedite its global development process.

On August 8, 2025 Boehringer Ingelheim reported that HERNEXEOS (zongertinib tablets) has been approved by the U.S. Food and Drug Administration (FDA) (Press release, Boehringer Ingelheim, AUG 8, 2025, View Source [SID1234655042]). The kinase inhibitor is indicated for the treatment of adult patients with unresectable or metastatic non-squamous non-small cell lung cancer (NSCLC) whose tumors have HER2 (ERBB2) tyrosine kinase domain activating mutations, as detected by an FDA-approved test, and who have received prior systemic therapy.1

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This indication is approved under accelerated approval based on objective response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.1

"With the approval of zongertinib, we have an effective, targeted, orally administered treatment option for patients with HER2 (ERBB2)-mutant non-small cell lung cancer in the U.S. that not only elicits a durable response but, importantly, has a manageable safety profile," said Dr. John Heymach, MD, PhD, chair of Thoracic/Head and Neck Medical Oncology at The University of Texas MD Anderson Cancer Center, and coordinating investigator for the Beamion-LUNG 1 trial. "In a patient population where there are currently limited treatment options, this approval represents a significant advancement in cancer care."

Accelerated approval is based on data from the Phase Ib Beamion-LUNG 1 trial, demonstrating an objective response rate of 75% (N=71), 6% of patients had a complete response and 69% of patients had a partial response and a duration of response of ≥6 months in 58% of patients (n=53).1 Positive results from the Beamion-LUNG 1 trial were previously presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2025 and simultaneously published in The New England Journal of Medicine.2

Zongertinib demonstrated a manageable safety profile with a 2.9% discontinuation rate. In the pooled safety population, the most common (> 20%) adverse reactions were diarrhea (53%), hepatotoxicity (27%), rash (27%), fatigue (22%), and nausea (21%).1

"We are grateful to be able to bring forward HERNEXEOS, which has the potential to reset the benchmark for those living with HER2-mutant advanced non-small cell lung cancer, a condition associated with a particularly poor prognosis," said Shashank Deshpande, Chairman of the Board of Managing Directors and Head of Human Pharma at Boehringer Ingelheim. "Believing in the power of scientific innovation, we aim to provide meaningful improvements to this patient population. Recognizing its potential, we accelerated development to deliver this new treatment option to patients within four years of starting the first clinical trial."

Harnessing the power of precision medicine by targeting HER2 mutations in lung cancer
HER2 (ERBB2) mutations occur in approximately 2–4% of NSCLC cases and are associated with a poor prognosis and higher incidence of brain metastases.3,4,5Alterations in the HER2 (ERBB2) gene, including mutations, amplification and overexpression, trigger uncontrolled cell proliferation, inhibiting cell death, and promoting tumor growth and spread.3,5 Comprehensive biomarker testing using next generation sequencing determines a patient’s eligibility for treatment with zongertinib by identifying HER2 (ERBB2)-mutant advanced NSCLC.1,5

"The advocacy community is thrilled about the approval of zongertinib, as it is another testament to the importance of personalized options for lung cancer that allow for a much more targeted approach for a subgroup of patients who have been waiting many years for innovative treatments," said Marcia Horn, President and CEO, International Cancer Advocacy Network and Executive Director of the Exon 20 Group/HER2 Warriors. "Understanding your cancer’s unique biomarkers, including HER2, through comprehensive testing is critical for all patients with NSCLC, as it can unlock targeted treatment options."

About non-small cell lung cancer (NSCLC)
Lung cancer claims more lives than any other cancer type and the incidence is set to increase to over 3 million cases worldwide by 2040.5,6 NSCLC is the most common type of lung cancer.3 Due to a lack of symptoms and misdiagnoses,7 most patients with NSCLC present at stage III or IV, where the disease has metastasized locally or to other organs.8 The estimated 5-year survival rate historically has been less than 10% for metastatic disease.9,10,11 People living with advanced NSCLC can experience a detrimental physical, psychological, and emotional impact on their daily lives.12,13,14

About zongertinib
Zongertinib is a tyrosine kinase inhibitor (TKI) that selectively inhibits HER2 (ERBB2).1 This orally administered, targeted therapy was approved as HERNEXEOS (zongertinib tablets) under the FDA’s Accelerated Approval Program, after securing Priority Review as well as Breakthrough Therapy and Fast Track Designations.1

The treatment is being evaluated in ongoing trials, across a range of advanced solid tumors with HER2 alterations.