Acrivon Reports Second Quarter 2026 Financial Results and Highlights Upcoming 2026 Clinical Data Catalysts

On August 12, 2026 Acrivon Therapeutics, Inc. ("Acrivon" or "Acrivon Therapeutics") (Nasdaq: ACRV), a clinical stage biotechnology company discovering and developing precision medicines utilizing its proprietary Generative Phosphoproteomics AP3 (Acrivon Predictive Precision Proteomics) platform deployed for rational drug design and predictive clinical development, reported financial results for the second quarter ended June 30, 2026 and reviewed recent business highlights.

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"As we look ahead to the second half of 2026, we remain excited about the continued rapid clinical advancement of our precision medicine pipeline," said Peter Blume-Jensen, M.D., Ph.D., chief executive officer, president and co-founder of Acrivon. "For ACR-368, this includes the prespecified interim analysis of the registrational-intent, all-comer, serous endometrial cancer arms of the Phase 2b study. For ACR-2316, we have recently entered the randomized dose expansion stage in our Phase 1/2 study, supported by a favorable, differentiated safety profile and durable single-agent activity, including in heavily pretreated lung cancer subjects. Several subjects from the dose escalation phase now remain on treatment for more than one year."

Recent Highlights

ACR-368

Dosing continues in both all-comer serous EC arms (Arm 4 single agent and Arm 3 with ultra-low dose gemcitabine sensitization) in the registrational-intent Phase 2b study, across both US and European clinical sites.
Two presentations at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting highlighted data showing the underlying molecular mechanisms for potent synergies between ACR-368 and immune checkpoint inhibitors (ICIs) or Topoisomerase 1 (Topo 1) inhibitors identified by AP3. These findings support the potential for clinical combination studies with antibody-drug conjugates (ADCs) or ICIs.
ACR-2316

ACR-2316 advanced into the randomized dose expansion stage of the Phase 1/2 study, supported by observed favorable safety profile and durable antitumor activity. The expansion phase is evaluating 120 mg and 160 mg doses, administered orally, once-daily (QD) utilizing a 3d on / 4d off weekly administration schedule.
Dose expansion phase will assess safety and activity in subjects with AP3-identified, molecularly-defined lung, endometrial, cervical, and esophago-gastric junction cancers.
Data presented at the AACR (Free AACR Whitepaper) Annual Meeting uncovered the molecular underpinnings driving strong synergy and resulting in complete tumor regression with durable immune memory upon treatment with ACR-2316 and ICI, providing a mechanistic rationale for potential combinations with ICIs.
Oral podium and poster presentations at the AACR (Free AACR Whitepaper) Drug Discovery and Development conference demonstrated how AP3 guided the design of ACR-2316 for optimal intracellular pathway effects, including sustained activation of CDK1, CDK2, and importantly also of PLK1, and quenching of the dominant resistance mechanisms to drive potent pro-apoptotic tumor cell death.
CDK11 Inhibitor Program

Internally-discovered development candidate from company’s AP3-driven cell cycle program and several equally promising back-up lead compounds showing complete regression in preclinical in vivo AML models being advanced in Investigational New Drug (IND)-enabling studies.
Anticipated Upcoming Milestones

ACR-368 Ongoing Registrational Intent Phase 2b Study

A prespecified simultaneous interim analysis and data update from both all-comer (biopsy-independent) serous EC arms of the ACR-368 Phase 2b study in second half of 2026
Initiate Phase 3 confirmatory trial for ACR-368 in first half of 2027
Based on interim data read-out, complete enrollment of the registrational intent all-comer (biopsy-independent) serous EC Arm 3 or Arm 4 by fourth quarter of 2026
Broader Pipeline

Submit IND filing to the FDA for CDK11 inhibitor development candidate in first half of 2027
Initiate additional AP3-driven drug discovery programs in 2026
Second Quarter 2026 Financial Results

Net loss for the quarter ended June 30, 2026 was $18.0 million compared to a net loss of $21.0 million for the same period in 2025.

Research and development expenses were $13.8 million for the quarter ended June 30, 2026 compared to $16.2 million for the same period in 2025. The difference is primarily driven by two milestones achieved for ACR-368 in 2025 which did not recur in 2026, as well as timing of the progression of other programs.

General and administrative expenses were $4.8 million for the quarter ended June 30, 2026, compared to $6.5 million for the same period in 2025. The difference was primarily due to a decrease in employee-related expenses, including stock-based compensation.

As of June 30, 2026, the company had cash, cash equivalents and investments of $90.0 million, which is expected to fund operating expenses and capital expenditure requirements into the fourth quarter of 2027.

(Press release, Acrivon Therapeutics, AUG 12, 2026, View Source [SID1234670034])

LeonaBio to Highlight Lasofoxifene in ER-positive (ER+), HER2-negative, ESR1-mutated Metastatic Breast Cancer at DAVA Oncology’s 4th Summit on Breast Cancer

On August 12, 2026 LeonaBio, Inc. (NASDAQ: LONA), a clinical-stage biopharmaceutical company dedicated to the development of novel therapeutics for diseases with high unmet medical needs, reported that its lead product candidate, lasofoxifene, will be featured in multiple presentations at Dava Oncology’s 4th Summit on Breast Cancer taking place from August 18-22, 2026, in Kona, Hawaii.

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"We are honored to share the body of clinical and scientific evidence supporting lasofoxifene as a potential treatment for metastatic breast cancer with many of the world’s leading breast cancer experts," said Mark Litton, Ph.D., President and Chief Executive Officer of LeonaBio. "Patients with metastatic breast cancer continue to face significant challenges as resistance emerges and treatment options become limited. We believe lasofoxifene has the potential to redefine the treatment paradigm for these patients through its differentiated mechanism of action and promising clinical profile. As we advance toward completion of enrollment in our pivotal Phase 3 ELAINE-3 trial, we remain focused on obtaining the data needed to bring a potential new therapeutic option to patients as quickly as possible."

Jessica Tao, M.D., a medical oncologist specializing in breast cancer at Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, will present on lasofoxifene, including the Phase 3 ELAINE-3 clinical trial of lasofoxifene in combination with abemaciclib in the treatment of ER-positive (ER+), HER2-negative, ESR1-mutated metastatic breast cancer on Wednesday, August 19, 2026, at 8:02 am Hawaii time.

In addition, David Portman, M.D., Founder and Chief Executive Officer of Sermonix and a consultant to LeonaBio, will lead an Industry Lunch Presentation on the development of lasofoxifene and its potential as a treatment for metastatic breast cancer on Thursday, August 20, 2026, at 12:25 pm Hawaii time.

"We are excited by the opportunities that success in ELAINE-3 could create, not only in potentially establishing lasofoxifene in combination with CDK4/6 inhibition as a new standard of care in metastatic breast cancer but also informing future testing in different combination strategies and additional breast cancer settings," concluded Dr. Litton.

(Press release, LeonaBio, AUG 12, 2026, View Source [SID1234670033])

NeOnc Technologies Reports Positive Topline Phase 2a Results for Intranasal NEO100 in Recurrent IDH1-Mutant High-Grade Glioma

On August 12, 2026 NeOnc Technologies Holdings, Inc. (Nasdaq: NTHI) ("NeOnc" or the "Company"), a multi-Phase 2 clinical-stage biopharmaceutical company developing novel therapies for central nervous system (CNS) cancers, reported positive topline results from the Phase 2a portion of NEO100-01, an open-label study of intranasal NEO100 (purified perillyl alcohol) in patients with recurrent or progressive Grade III and Grade IV IDH1-mutant glioma.

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The study met its primary endpoint. Six-month progression-free survival (PFS-6) was 48.9% (95% CI: 26.3-68.1) by RANO 2.0 criteria using Kaplan-Meier estimation, compared with the 20% rate pre-specified in the study design as the expectation for standard of care (p = 0.0047).

"These results represent an important milestone for NeOnc and, more importantly, a source of hope for patients with recurrent high-grade glioma who currently have very limited treatment options. NEO100 met the study’s primary endpoint, demonstrated encouraging survival outcomes, and was administered intranasally by patients at home with no major toxicities reported. We believe these findings support the potential of our intranasal delivery platform to address one of the greatest challenges in treating brain cancer – the blood-brain barrier. Our priority now is to engage with the FDA and align on the most efficient path toward a registrational study," said Amir F. Heshmatpour, Executive Chairman, President and Chief Executive Officer.

Secondary survival endpoints were supportive. Median overall survival was 26.09 months, with 12 deaths among 24 patients. Overall survival was 86.7% at six months (95% CI: 64.3-95.5), 60.9% (95% CI: 36.4-78.4) at 12 months and 54.1% (95% CI: 29.5-73.4) at 24 months.

"We believe that these results are a powerful validation of the science behind NEO100," said Thomas C. Chen, MD, PhD, Founder, Chief Medical Officer and Chief Scientific Officer of NeOnc. "We set out to reach the brain directly, delivering therapy through the nose and along the olfactory pathway rather than forcing a drug past the blood-brain barrier, and what we are seeing in Phase 2a is what our biology predicted and what we saw in Phase 1, where every long-term survivor carried an IDH1 mutation. We believe that survival of this duration in twice-treated, high-grade disease, achieved with a therapy patients take at home and with no major toxicity, is the kind of result that justifies a much larger study."

Evidence of durable disease control was observed across the cohort. Five of 24 patients remain on active treatment. One patient has remained progression-free for approximately 19 months. A second patient achieved a partial response sustained for 114 days through the end of Cycle 8 and remains on treatment in response. Objective response rate was 8.3% (two of 24 patients) by RANO 2.0.

"In recurrent high-grade glioma, the outcome that matters is how long a patient can hold the disease at bay and still live their life," said Josh Neman, PhD, Chief Clinical Officer of NeOnc. "Five of our 24 patients remain on therapy, one progression-free approaching 19 months and another in an ongoing response approaching four months, and they are taking this treatment at home rather than in an infusion chair. Durability and tolerability together are rare at recurrence, and we believe that combination is what these data point to. We look forward to discussing the findings with the FDA."

The data suggests that NEO100 was well tolerated. No major toxicities were reported across the cohort, and adverse events to date have been predominantly low-grade. The tolerability profile is consistent with the Phase 1 portion of the study, in which the data suggested that NEO100 was well tolerated at all dose levels, with no severe or dose-limiting toxicities observed. The absence of significant toxicity is notable in a population receiving continuous therapy (several patients have now remained on daily intranasal dosing for well over a year) and reflects a delivery route designed to reach the brain without systemic cytotoxic exposure.

NEO100-01 is directed at a population that existing IDH-targeted therapies do not serve. Approved and late-stage IDH-targeted agents for glioma have been developed in the front-line setting for lower-grade disease, typically Grade 2, non-enhancing tumors in patients who have undergone surgery but have not yet received radiation or chemotherapy.

NEO100-01 enrolled the opposite population: patients with Grade III and Grade IV IDH1-mutant tumors that have recurred or progressed after radiation and temozolomide. There is no approved targeted therapy for these patients. Approximately 90% of high-grade glioma patients recur within six to nine months of maximal therapy, and at recurrence, surgery is often not repeatable and systemic agents face rapid resistance and cumulative toxicity.

NEO100 is administered intranasally by the patient at home, four times daily, in 28-day cycles, a delivery route designed to reach the brain directly while avoiding systemic cytotoxic exposure.

NeOnc intends to request a Type B meeting with the U.S. Food and Drug Administration to align on a registrational development path for NEO100 in recurrent IDH1-mutant high-grade glioma. Additional pre-specified analyses including the Grade III versus Grade IV subgroup analysis, pharmacokinetics, and quality-of-life measures are ongoing and will be reported separately. The Company expects to present the full Phase 2a dataset, including detailed safety, at a future medical meeting.

Conference Call and Webcast

NeOnc will host an investor conference call and webcast today at 5:30 a.m. Pacific Time / 8:30 a.m. Eastern Time to discuss these results, followed by a question and answer session. The live webcast can be accessed at View Source or by visiting View Source." target="_blank" title="View Source." rel="nofollow">View Source A replay will be available at View Source shortly following the conclusion of the call.

About the NEO100-01 Phase 2a study

NEO100-01 is an open-label, multi-center Phase 1/2a study of intranasal NEO100 in patients with radiographically confirmed progression of, or recurrence of, primary or secondary Grade IV glioma or Grade III astrocytoma harboring an IDH1 mutation. All patients had previously failed radiation or combined temozolomide and radiation. The Phase 2a portion enrolled 24 patients of a planned 28 at the recommended Phase 2 dose of 1,152 mg/day, self-administered intranasally four times daily in 28-day cycles until progression, death, or withdrawal.

The primary endpoint is the progression-free survival rate at six months. Secondary endpoints include objective response rate by RANO 2.0 criteria, progression-free survival, overall survival, safety and tolerability, pharmacokinetics, and quality of life. All MRI scans were read by an independent central reviewer. Biostatistical analysis was conducted by Anova Enterprises, Inc. Efficacy results are reported for the intent-to-treat population. Response and progression were assessed using RANO 2.0 criteria.

About NEO100

NEO100 is a patented, ultra-pure pharmaceutical-grade formulation of perillyl alcohol, a naturally occurring monoterpene found in citrus and peppermint oils, produced through a proprietary crystalline synthesis process. Administered intranasally using a commercial nasal mask and nebulizer, NEO100 is designed to deliver therapy directly to the brain along olfactory and trigeminal pathways, bypassing the blood-brain barrier and avoiding first-pass metabolism and systemic toxicity. Data from preclinical studies suggests that NEO100 may transiently and reversibly open the blood-brain barrier, enabling brain entry of otherwise impermeable therapeutics.

(Press release, Neonc, AUG 12, 2026, View Source [SID1234670032])

RenovoRx Reports Record Second Quarter 2026 Results, Driven by Accelerating Commercial Adoption and 61% Sequential Quarterly Revenue Growth

On August 12, 2026 RenovoRx, Inc. ("RenovoRx" or the "Company") (Nasdaq: RNXT), a life-sciences company developing innovative targeted oncology therapies and commercializing RenovoCath, a patented, FDA-cleared drug-delivery device, reported its financial results for the second quarter ended June 30, 2026, and provided shareholders with a business update highlighting continued commercial momentum and clinical progress.

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"In the second quarter of 2026, we delivered record revenue and executed on all three of the milestones we set for the business: revenue growth with another record revenue quarter, commercial momentum evidenced by several cancer center activations, and expansion of the application of our technology beyond locally advanced pancreatic cancer (LAPC)," said Shaun Bagai, Chief Executive Officer of RenovoRx. "We generated quarterly revenue of $909,000, an increase of approximately 61% compared to the first quarter of 2026, and approximately 115% compared to the second quarter of 2025. Our strong first half performance gives us confidence that our second half revenue will exceed our original full year forecast. This outlook is driven by more active commercial cancer center customers, more patients treated via procedures with RenovoCath, and repeat ordering across our existing customer base."

Mr. Bagai continued, "We ended the second quarter with 21 active commercial cancer center customers, an increase of more than 30% from the 16 centers reported at the time of our first quarter earnings call, and expanded our total commercial pipeline to 63 centers, including 42 additional centers progressing through evaluation, approval, and activation. We continue to see meaningful repeat utilization across our existing customer base, and for the first time, a treating physician chose RenovoCath to deliver therapy to a patient with a solid tumor beyond pancreatic cancer, marking an important, physician-driven expansion of the clinical application of our TAMP platform."

"Looking ahead, we remain focused on executing against both our near-term commercial priorities and our long-term clinical objectives," added Mr. Bagai. "Based on current trends, we expect third quarter revenue to surpass second-quarter revenue and set another record. We remain on track to meet or exceed our target of 36 active commercial cancer center customers by year end 2026."

"The recently announced enrollment completion of our Phase III TIGeR-PaC trial positions the majority of our trial sites to also transition to commercial use in the second half of the year. Reflecting our strong first half performance, we are raising and tightening the range for our full year revenue guidance. In short, we believe RenovoRx is building a durable, capital-efficient commercial business," said Mr. Bagai. "Management believe that reaching a quarterly revenue run-rate of approximately $5 million would position RenovoRx at cash-flow break-even, and based on our current trajectory, our internal plan anticipates achieving break-even operations in the fourth quarter of 2027."

RenovoCath Commercialization Update
RenovoRx delivered its strongest quarterly revenue performance to date. Revenue totaled $909,000 for the second quarter, an increase of approximately 61% compared to the first quarter of 2026 and approximately 115% compared to the second quarter of 2025. Second quarter revenue alone represented approximately 83% of the Company’s total revenue generated in all of 2025. For the six months ended June 30, 2026, revenue totaled approximately $1.5 million. This growth reflects continued expansion of active commercial cancer center customers and increasing procedural utilization of RenovoCath across the Company’s growing base of commercial sites.

The Company’s commercial model is currently focused on activating new cancer center customers, which have been a source of recurring demand. RenovoRx ended the second quarter of 2026 with 21 active commercial cancer center customers, an increase of more than 30% from the 16 active customers reported at the time of the Company’s first quarter 2026 earnings call. RenovoRx is also advancing a customer pipeline of 42 additional centers in various stages of evaluation, approval, or activation. Combined with its 21 active customers, this represents a total of 63 centers in the Company’s commercial funnel, a 31% increase compared to the 48 total centers reported on its first quarter call. The Company remains on pace to meet or exceed its target of 36 active commercial cancer center customers by year end 2026. In addition, 15 Phase III TIGeR-PaC clinical trial sites are positioned to transition to commercial RenovoCath use, several of which have already begun doing so. These sites represent an anticipated and meaningful contributor to revenue in the second half of 2026.

RenovoRx continues to observe strong repeat ordering from existing customers, which the Company views as one of the clearest indicators of physician satisfaction and clinical utility in interventional oncology. As physicians incorporate RenovoCath into routine clinical practice, repeat utilization is expected to drive sustained revenue growth. Based on its current customer pipeline and trends to date, the Company expects third quarter 2026 revenue to exceed second quarter revenue which would represent another consecutive record revenue quarter.

Since receiving FDA 510(k) clearance, RenovoCath has been used in more than 900 successful procedures. RenovoRx continues to estimate that the initial total addressable market (TAM) for RenovoCath as a stand-alone device could translate into an approximately $400 million peak annual U.S. sales opportunity for RenovoRx. Over time, as the Company expands the platform into additional solid tumor indications, the Company believes it could unlock more than $1 billion in peak annual sales potential.

Expansion of RenovoCath Beyond Locally Advanced Pancreatic Cancer
In early August 2026, RenovoRx announced the first commercial clinical use of RenovoCath by an existing cancer center customer in the treatment of sarcoma, marking the expansion of its targeted drug-delivery device to solid tumors beyond pancreatic cancer. The case involved a physician who had previously treated LAPC patients using RenovoCath and returned to RenovoRx with a plan to use the catheter to treat sarcoma. The Company views this physician-driven adoption as a meaningful endorsement of RenovoCath’s potential as a standalone device across additional difficult-to-treat solid tumors within its FDA-cleared fields of use.

Ongoing Phase III TIGeR-PaC Trial Update
Recently, RenovoRx announced that it achieved full enrollment in its Phase III TIGeR-PaC trial evaluating intra-arterial delivery of intra-arterial gemcitabine (IAG) via the RenovoCath device for the treatment of LAPC. This significant milestone reflects successful patient recruitment, clinical execution, and collaboration among investigators and study teams evaluating IAG for LAPC, a difficult-to-treat cancer. The primary endpoint of the study is overall survival. TIGeR-PaC is designed to evaluate whether RenovoRx’s patented method of targeted delivery of the chemotherapy gemcitabine improves patient survival, safety, and tolerability compared to the standard of care (systemic (intravenous) chemotherapy gemcitabine + Abraxane).

As of August 7, 2026, TIGeR-PaC trial investigators have been notified by RenovoRx that patient enrollment is closing. Completion of the trial is expected during the first half of 2027, after 86 events (i.e., patient deaths) have been observed. As of August 11, 2026, 78 events have occurred. Following completion of the trial, initial topline trial data is expected to be available during the second half of 2027.

With enrollment complete, RenovoRx is now focused on advancing toward final data analysis. These efforts build on the successful completion of the second interim analysis in 2025, after which the independent Data Monitoring Committee recommended continuation of the trial without modification. To preserve trial integrity, the Company elected to defer publication of interim data until study completion.

RenovoRx continues to view TIGeR-PaC as a critical long-term value driver, while emphasizing that its current commercial strategy is independent of the trial’s ultimate outcome and timeline.

Second Quarter 2026 and Subsequent Key Highlights
RenovoRx continued to execute on its dual commercial and clinical strategy during the second quarter of 2026 and the subsequent period, building real-world evidence base for its TAMP platform.

During the second quarter of 2026, several scientific data updates supported the use of intra-arterial gemcitabine delivery via TAMP in LAPC. A peer-reviewed case study by researchers at Moffitt Cancer Center, published in Radiology Case Reports, found that PET-CT imaging, rather than CT alone, showed a meaningful reduction in tumor metabolic activity after treatment. These findings suggest that PET imaging may help optimize monitoring of therapeutic response following TAMP-delivered treatment.

In addition, the PK sub-study of the TIGeR-PaC trial has been accepted and will be published in the near future in the Journal of Cancer Chemotherapy and Pharmacology. The findings support TAMP as a targeted delivery method for gemcitabine, demonstrating its potential to increase local drug potency while reducing systemic exposure and common side effects.

Finally, a peer-reviewed case series in Case Reports in Oncology from researchers at Hackensack Meridian Health’s Jersey Shore University’s Medical Center was accepted and will be published in the near future. The case series highlights their experience with the TAMP procedure in LAPC.

The ramping up of publication of the TAMP procedure by physicians, the Company believes is another sign of adoption as TAMP traverses from an experimental procedure to becoming a potential standard of care.

Cash Resources, History of Losses and Planned Activities
RenovoRx continued to build the evidence base for its TAMP platform through a multi-center post-marketing registry study generating real-world safety and efficacy data, as well as investigator-initiated trials (IITs) in borderline resectable and metastatic pancreatic cancer designed to achieve cost neutrality while broadening the platform’s evidence base. In the second quarter of 2026, the Company began supporting a new IIT in cholangiocarcinoma (bile duct cancer).

RenovoRx received FDA Orphan Drug Designation for oxaliplatin in the treatment of pancreatic cancer in the second quarter of 2026, further expanding the potential applications of its targeted drug-delivery platform.

Financial Highlights for the Second Quarter Ended June 30, 2026

Revenue for the three months ended June 30, 2026 was $909,000, compared to $422,000 for the three months ended June 30, 2025. The increase was driven by the continued commercialization of RenovoCath and expanding adoption across U.S. cancer centers.
Gross profit for the three months ended June 30, 2026 was $766,000, representing a gross margin of approximately 84%, consistent with the approximately 85% gross margin in the first quarter of 2026 and reflecting the underlying economics of RenovoCath.
Research and development expenses were approximately $1.2 million for the three months ended June 30, 2026, compared to approximately $1.4 million for the three months ended June 30, 2025.
Selling, general, and administrative expenses were approximately $2.9 million for the three months ended June 30, 2026, compared to approximately $1.5 million for the three months ended June 30, 2025, a reflection of the Company’s continued execution on its commercial infrastructure strategy.
Net loss for the three months ended June 30, 2026, was approximately $2.9 million, compared to approximately $2.9 million for the three months ended June 30, 2025. Net loss per share was $0.06 for the three months ended June 30, 2026, compared to a net loss of $0.08 for the three months ended June 30, 2025.
Cash and cash equivalents were approximately $9.5 million as of June 30, 2026, compared to approximately $12.4 million as of March 31, 2026. This evidences the disciplined deployment of capital raised in the Company’s March 2026 private placement. The Company believes its current cash resources are sufficient to fund operations into the second half of 2027.
Shares Outstanding: As of June 30, 2026, common shares outstanding totaled 45,121,982.
Guidance: RenovoRx is raising and tightening the range of its full-year 2026 revenue guidance to a range of $3.75 million to $4.25 million, from its prior range of $3.0 million to $4.0 million. The updated guidance implies year-over-year revenue growth of approximately 241% to 286% compared to full-year 2025 revenue of $1.1 million.

Conference Call Details
Event: RenovoRx Second Quarter 2026 Financial Results and Business Highlights Conference Call
Date: Wednesday, August 12, 2026
Time: 4:30 p.m. ET
Live Call: 1-877-407-4018 (U.S. Toll Free) or 1-201-689-8471 (International)
Webcast: View Source

(Press release, Renovorx, AUG 12, 2026, View Source [SID1234670031])

Natera to Support New Clinical Trial Assessing ctDNA Dynamics with Latitude™ in Advanced Skin Cancers

On August 12, 2026 Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA and precision medicine, reported a new collaboration regarding a Phase 1 clinical trial, sponsored by Kupando Therapeutics.

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Under the agreement, Natera’s Latitude tissue-free assay for molecular residual disease (MRD) detection will be used in Kupando’s clinical trial of its lead immunotherapy candidate, KUP-101. The trial will assess serial circulating tumor DNA (ctDNA) dynamics as part of treatment response monitoring. Patients with advanced tumors across multiple skin cancers will be treated with KUP-101 and Latitude MRD testing will be performed at multiple timepoints.

Following the successful dosing of the first patient, Kupando’s safety committee has approved the ongoing enrollment of further patients across the activated clinical sites, including leading oncology centers in Germany.

KUP-101 is designed to activate the innate immune system and induce trained immunity. It has potential as a tissue-agnostic treatment across multiple solid tumor types, both as a standalone therapy and in combination with other agents. To evaluate molecular response in this setting, the Latitude test is well suited to assess treatment response in the trial.

"Dosing our first patient is a defining inflection point in Kupando’s history," said Johanna Holldack, M.D., founder and chief executive officer, Kupando Therapeutics. "By leveraging the power of innate immune stimulation and the induction of trained immunity, KUP-101 represents a fundamentally different way of approaching hard-to-treat cancers. Natera’s Latitude test can provide valuable insights into treatment response dynamics, helping us better understand the molecular activity of this novel therapeutic approach and advance our clinical development program for patients with advanced solid tumors."

"We are pleased to work with Kupando as they advance this promising first-in-class approach to innate immune activation," said Eric Matthews, general manager, biopharma, Natera. "Latitude’s capabilities make it ideally suited to evaluate ctDNA dynamics across diverse solid tumor types, and we look forward to generating molecular insights that can support Kupando’s development of KUP-101 and ultimately help patients with difficult-to-treat cancers."

(Press release, Natera, AUG 12, 2026, View Source [SID1234670030])