Faeth Therapeutics to Present PK/PD Modeling That Informed PIKTOR Dose Selection in Ongoing FTH-PIK-201 Trial at Upcoming Scientific Conference

On August 7, 2026 Faeth Therapeutics (Nasdaq: FTH), a clinical-stage oncology company developing PIKTOR, an investigational all-oral, multi-node inhibitor of the PI3K/AKT/mTOR pathway, reported it will present translational data and pharmacokinetic/pharmacodynamic (PK/PD) analysis for PIKTOR, its oral combination of serabelisib and sapanisertib, at the 2026 Summit for Novel Therapeutics in Oncology & Precision Medicine in Cancer (STOP Cancer), held August 7-8 in New York.

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The poster titled "Exposure/Response Analysis of an Oral Multi-Node PI3K/AKT/mTOR Pathway Inhibitor Combination of Serabelisib and Sapanisertib" will be presented on August 8 between 10:25 and 11:30 AM at the New York Marriott Marquis in New York, NY (Poster #9).

Data to be reported include a PK/PD analysis that integrates skin biopsy data and PK modeling from earlier third-party clinical trials of serabelisib and sapanisertib. Together, these data informed selection of 3 mg sapanisertib and 200 mg serabelisib three days a week as the recommended Phase 2 dose for PIKTOR in the ongoing Phase 2 trial in second-line advanced endometrial cancer, Study FTH-PIK-201 (NCT06463028).

A copy of the poster will be made available in the Investors section of Faeth’s website at the start of the poster session.

About PIKTOR

PIKTOR is an investigational, proprietary, all-oral combination of serabelisib, a selective PI3K-alpha inhibitor, and sapanisertib, an mTORC1/mTORC2 inhibitor, designed to inhibit multiple nodes of the PI3K/AKT/mTOR pathway. According to published literature, this pathway is dysregulated in up to 50% of all solid tumors, making it one of the most prevalent therapeutic targets in oncology. PIKTOR is being evaluated in a Phase 2 trial in second-line advanced endometrial cancer (Study FTH-PIK-201), with topline data anticipated by year-end 2026. PIKTOR is also being evaluated in a Phase 1b/2 trial in HR+/HER2- advanced breast cancer (Study FTH-PIK-101), in which the first patient was dosed in April 2026 and interim data is anticipated in 2027.

(Press release, Faeth Therapeutics, AUG 7, 2026, View Source [SID1234669880])

aTyr Pharma Announces Second Quarter 2026 Results, Program Prioritization and Corporate Restructuring to Support Efzofitimod Program in ILD

On August 7, 2026 aTyr Pharma, Inc. (Nasdaq: ATYR) ("aTyr" or the "Company"), a clinical stage biotechnology company engaged in the discovery and development of first-in-class medicines from its proprietary tRNA synthetase platform, reported second quarter 2026 results and a corporate restructuring to prioritize its efzofitimod program in interstitial lung disease (ILD), including pulmonary sarcoidosis and systemic sclerosis (SSc)-related ILD (SSc-ILD).

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The program prioritization aims to focus the Company’s resources on advancing its lead asset, efzofitimod, and targeted pipeline development to conserve capital in anticipation of receiving comments from the U.S. Food and Drug Administration (FDA) on the protocol for its planned Phase 3 study of efzofitimod in pulmonary sarcoidosis, a major form of ILD. The Company submitted the protocol in June 2026 and is expecting feedback from the FDA by the end of August 2026.

"We are proactively taking decisive, necessary action to focus our resources on our lead therapeutic candidate, efzofitimod, as we await feedback from the FDA on the protocol we submitted for our planned Phase 3 study in pulmonary sarcoidosis patients with restrictive lung disease. This approach positions aTyr to advance this planned Phase 3 study efficiently and continue completing the Phase 2 EFZO-CONNECT study in SSc-ILD," said Sanjay S. Shukla, M.D., M.S., President and Chief Executive Officer of aTyr. "We remain confident in the potential of efzofitimod to become a meaningful therapy for patients with these forms of ILD, and these changes are essential to our ability to achieve that goal. We are deeply grateful to our dedicated team members for their outstanding contributions, commitment, and perseverance, including those who have helped advance tRNA synthetase biology over the years."

Program Prioritization and Corporate Restructuring

Workforce reduction of approximately 60% will align organizational resources to support the efzofitimod program in ILD in anticipation of comments from the FDA on a protocol submitted for a planned Phase 3 study in pulmonary sarcoidosis and to complete the Phase 2 EFZO-CONNECT study in SSc-ILD.
Jill Broadfoot, aTyr’s Chief Financial Officer (CFO), will step down as of September 30, 2026, and transition to serve as a consultant to the Company. Brandon Yaras, aTyr’s Vice President of Finance, will be appointed as CFO as of October 1, 2026.
Nancy Denyes, aTyr’s General Counsel, will step down as of September 30, 2026, and transition to serve as a consultant to the Company.
The Company expects that this restructuring and additional cost saving measures will reduce annualized operating expenses by approximately $13 million, beginning in the fourth quarter of 2026.

Second Quarter 2026 and Subsequent Period Highlights

Protocol submitted to FDA in June 2026 for planned Phase 3 study in patients with chronic, symptomatic pulmonary sarcoidosis with restrictive lung disease. The Company is expecting feedback from the FDA by the end of August 2026. The Phase 3 trial is expected to be a global, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of efzofitimod in patients with moderate to severe pulmonary sarcoidosis. The 54-week study will consist of two parallel cohorts randomized equally to either 5.0 mg/kg efzofitimod or placebo dosed intravenously once every 3 weeks for a total of 17 doses. The study is intended to enroll up to approximately 372 patients with symptomatic pulmonary sarcoidosis with restrictive lung disease who are receiving a stable dose of ≤ 5.0 mg daily oral corticosteroid and/or a background immunosuppressant. All background treatment will remain stable throughout the duration of the study. The primary endpoint of the study will be change from baseline in forced vital capacity (FVC) at week 48 and the key secondary endpoint will be change from baseline in the King’s Sarcoidosis Questionnaire-Lung score at week 48.
Enrollment completed in the Phase 2 EFZO-CONNECT study to evaluate the efficacy, safety and tolerability of efzofitimod in patients with limited or diffuse SSc-ILD. Topline results are expected in the first quarter of 2027. This proof-of-concept study is a randomized, double-blind, placebo-controlled, 28-week study consisting of three parallel cohorts randomized 2:2:1 to either 270 mg or 450 mg of efzofitimod or placebo administered intravenously monthly for a total of six doses. The study enrolled 23 patients at multiple centers in the United States. Promising interim data from the study were reported in the second quarter of 2025.
Post hoc analysis of Phase 3 EFZO-FIT study in subgroup of patients with restrictive lung disease presented in a poster at the World Association of Sarcoidosis and Other Granulomatous Disorders (WASOG) 2026 Congress in Porto, Portugal. The poster, which is titled, "Evaluating Efzofitimod in a Subset of Sarcoidosis with the Restrictive Phenotype," demonstrated clinically meaningful benefit for FVC and improvement in multiple patient-reported outcomes for patients treated with 5.0 mg/kg efzofitimod compared to placebo. The poster is available on the Company’s website.

Second Quarter 2026 Financial Highlights and Cash Position

Cash & Investment Position: Cash, cash equivalents, restricted cash and available-for-sale investments as of June 30, 2026, were $58.9 million. Based on its current cash and new operating expense forecast and plans, the Company anticipates that this cash position will be sufficient to fund the Company’s current operations into late 2028. Future development of efzofitimod in the planned Phase 3 study in pulmonary sarcoidosis will require the Company to obtain additional capital through equity or debt offerings, grant funding, collaborations, strategic partnerships and/or licensing arrangements.
R&D Expenses: Research and development expenses were $6.7 million for the second quarter 2026, which consisted primarily of costs for the Phase 2 EFZO-CONNECT study and research and development costs for the Company’s preclinical product candidates.
G&A Expenses: General and administrative expenses were $4.1 million for the second quarter 2026.

About Efzofitimod

Efzofitimod is a novel biologic immunomodulator in clinical development for the treatment of interstitial lung disease (ILD), a group of immune-mediated disorders that can cause inflammation and fibrosis, or scarring, of the lungs. Efzofitimod is a tRNA synthetase derived therapy that selectively modulates activated myeloid cells through neuropilin-2 to resolve inflammation without immune suppression and potentially prevent the progression of fibrosis. Efzofitimod is currently being investigated in the Phase 2 EFZO-CONNECT study in patients with systemic sclerosis (SSc, or scleroderma)-related ILD, and aTyr recently submitted a protocol to the FDA for a global Phase 3 study of efzofitimod in patients with pulmonary sarcoidosis, a major form of ILD. These forms of ILD have limited therapeutic options and there is a need for safer and more effective, disease-modifying treatments that improve outcomes.

(Press release, aTyr Pharma, AUG 7, 2026, View Source [SID1234669879])

Xenetic Biosciences Reports Second Quarter 2026 Financial Results and Highlights Strengthened Scientific Foundation Supporting Continued Advancement of Proprietary DNase Platform

On August 7, 2026 Xenetic Biosciences, Inc. (NASDAQ:XBIO) ("Xenetic" or the "Company"), a biopharmaceutical company focused on advancing innovative immuno-oncology technologies addressing difficult to treat cancers, reported financial results for the quarter ended June 30, 2026, and provided a corporate update on continued execution of its long-term strategy to advance its proprietary DNase platform through scientific collaboration and translational research.

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Recent Highlights

Positive preclinical and translational data presented at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting demonstrating that DNase I significantly enhanced CAR T-cell expansion, persistence, tumor control and survival across preclinical hematologic cancer models

Announced that collaboration partner, PeriNess Ltd., received approval from the Israeli Ministry of Health and the respective Institutional Review Board to conduct an investigator-initiated exploratory study evaluating systemic recombinant human DNase I in combination with anti-CD19 CAR T-cell therapy in patients with large B-cell lymphoma at Tel Aviv Sourasky Medical Center

Received approximately $1.5 million in royalty revenue during the first six months of 2026

"We continue to generate strong translational data as evidenced by what was presented at ASCO (Free ASCO Whitepaper), further supporting the potential of DNase I as a differentiated adjunct therapy designed to improve the efficacy and durability of CAR T-cell therapies," said James Parslow, Interim Chief Executive Officer and Chief Financial Officer of Xenetic. "Throughout the second quarter, we continued expanding the scientific foundation supporting our proprietary DNase technology while prudently allocating capital toward activities designed to both inform future clinical development and advance our ongoing strategic review process. We believe this disciplined approach, combined with continued royalty revenue from our legacy PolyXen technology, positions Xenetic to pursue long-term opportunities that have the potential to create meaningful value for both patients and shareholders."

Xenetic is advancing its proprietary DNase platform as a differentiated approach designed to enhance the effectiveness of existing cancer therapies by targeting neutrophil extracellular traps (NETs), an increasingly recognized driver of tumor progression, immune suppression and therapeutic resistance. Through collaborations with leading academic institutions, the Company continues to expand the scientific understanding of NET biology while generating translational evidence intended to inform future clinical development and strengthen the long-term potential of its platform.

Summary of Financial Results for Second Quarter 2026

Royalty revenue for the three months ended June 30, 2026 increased approximately 12% to approximately $0.7 million, compared to approximately $0.6 million for the comparable prior-year period, primarily due to increased royalty revenue recognized under the Company’s sublicense agreement with Takeda Pharmaceuticals Co. Ltd.

Research and development expenses for the three months ended June 30, 2026 decreased approximately 16% to approximately $0.6 million, compared to approximately $0.7 million for the comparable prior-year period, primarily due to lower manufacturing development efforts and reduced consulting costs.

General and administrative expenses for the three months ended June 30, 2026 increased approximately 64% to approximately $1.1 million, compared to approximately $0.7 million in the comparable quarter of 2025. The increase was primarily attributable to higher legal expenses associated with the Company’s strategic review process.

Net loss for the quarter ended June 30, 2026 was approximately $0.9 million, compared to approximately $0.7 million for the same period in 2025.

The Company ended the second quarter of 2026 with approximately $6.5 million in cash and cash equivalents, compared to approximately $7.9 million as of December 31, 2025.

(Press release, Xenetic Biosciences, AUG 7, 2026, View Source [SID1234669877])

Verrica Pharmaceuticals Reports Second Quarter 2026 Financial Results

On August 7, 2026 Verrica Pharmaceuticals Inc. ("Verrica" or the "Company") (Nasdaq: VRCA), a therapeutics company developing and commercializing medications for the treatment of dermatological diseases, including skin cancers, reported financial results for the second quarter ended June 30, 2026.

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"Demand for YCANTH continues to accelerate, with dispensed applicator units reaching 19,626 for the quarter, up approximately 28% sequentially and 46% on a year-over-year basis, and representing our highest quarterly total since launch. We believe that our commercial strategy is working well and provides us with a growing confidence that YCANTH can become the standard of care for patients suffering from molluscum," said Jayson Rieger, PhD, MBA, President and Chief Executive Officer of Verrica.

"In addition to our commercial efforts, we also continue to make progress with our work to expand the label for YCANTH to include common warts, an indication that is more than three times the six million patients estimated to be suffering from molluscum. Topline data from our global Phase 3 program is currently expected in mid-2027, as our studies are recruiting well. We continue to enroll patients in the first pivotal study, COVE-2, and first patients in the U.S. and Japan were dosed in the second pivotal trial, COVE-3, during the quarter," Dr. Rieger continued. "With respect to our basal cell carcinoma program, we remain highly encouraged by the Phase 2 data for our novel oncolytic peptide, VP-315. At the Society for Investigative Dermatology Annual Meeting in May, VP-315 demonstrated a potential ability to impact both treated lesions, as well as showing evidence of a meaningful abscopal effect in untreated lesions. Based on the unique and promising profile of this Phase 3-ready asset, we are continuing our Phase 3 readiness activities."

Dr. Rieger concluded, "Finally, our new credit facility for up to $27.5 million with an entity controlled by Paul B. Manning, Verrica’s Chairman and largest shareholder, gives us access to additional non-dilutive capital to support YCANTH’s continued commercialization and advance our ongoing Phase 3 common warts program. Based on our current operating plan, we believe the full $27.5 million that may be available under the facility could extend our cash runway into 2028. We believe this quarter’s progress across our YCANTH business for molluscum and our pipeline programs, along with this extended cash runway, positions Verrica well to deliver long-term value for patients and shareholders."

Conference Call and Webcast Information

The Company will host a conference call on Thursday, August 6, 2026, at 4:30 pm, to discuss its second quarter 2026 financial results and provide a business update. To participate in the conference call, please utilize the following information:

Domestic Dial-In Number: Toll-Free: 1-800-225-9448

International Dial-In Number: 1-203-518-9708

Conference ID: VERRICA

Participants can use Guest dial-in #s above and be answered by an operator.

Webcast:

View Source;tp_key=a08a369194

The call will be broadcast live over the Web and can also be accessed on Verrica Pharmaceuticals’ website: www.verrica.com.

The conference call will also be available for replay for one month on the Company’s website in the Events Calendar of the Investors section.

Business Highlights and Recent Developments

YCANTH (VP-102)


During the second quarter of 2026, YCANTH dispensed applicator units totaled 19,626, representing a year-over-year increase of approximately 46% from the second quarter of 2025. On a sequential basis, YCANTH dispensed applicator units increased approximately 28% from the prior quarter.

On June 22, 2026, the Company announced that the first U.S. patient was dosed in the second pivotal clinical trial (COVE-3) in its global Phase 3 program evaluating YCANTH (VP-102) for the treatment of common warts in the US and Japan. Based upon current projections, the Company expects to present topline data from the program in mid-2027.

VP-315

On May 5, 2026, the Company announced the presentation of Phase 2 clinical data highlighting the potential abscopal effects of its novel oncolytic peptide, VP-315 (ruxotemitide), for the treatment of basal cell carcinoma (BCC) at the 2026 Society for Investigative Dermatology (SID) Annual Meeting.

Corporate


On August 6, 2026, the Company announced that it has entered into a credit agreement (the "Facility") with an entity controlled by Paul B. Manning, Verrica’s Chairman and largest shareholder for up to $27.5 million.


On July 21, 2026, the Company announced an exclusive distribution, marketing and supply agreement with Medomie Pharma Ltd., regarding commercial rights to YCANTH for the treatment of molluscum contagiosum in Israel.

Financial Results

Second Quarter 2026 Financial Results


Total revenue for the three months ended June 30, 2026, was $5.9 million compared to total revenue of $12.7 million for the three months ended June 30, 2025.


U.S. YCANTH product revenue, net was $5.1 million for the quarter ended June 30, 2026, compared to net product revenue of $4.5 million for the quarter ended June 30, 2025. The increase in product revenue, net, was primarily related to increased deliveries of YCANTH to our distribution partners.


License and collaboration revenue was $0.8 million for the quarter ended June 30, 2026, consisting primarily of commercial supply for Torii’s YCANTH launch in Japan, compared to license and collaboration revenue from Torii of $8.2 million for the three months ended June 30, 2025, which included $8.0 million of one-time milestone revenue.


Costs of product revenue were $0.4 million for the quarter ended June 30, 2026, compared to $0.3 million for the quarter ended June 30, 2025, consisting primarily of product costs related to the sale of YCANTH.


Selling, general and administrative expenses were $10.3 million for the quarter ended June 30, 2026, compared to $8.9 million for the same period in 2025. Excluding the impact of stock-based compensation, the increase of $1.3 million was primarily due to increased commercial spend, related to the expansion of the sales force.


Research and development expenses were $6.0 million for the quarter ended June 30, 2026, compared to $1.8 million for the same period in 2025. Excluding the impact of stock-based compensation, the increase of $4.1 million was primarily attributable to costs associated with the Phase 3 program for common warts. The expense for the Phase 3 common warts program did not impact Verrica’s cash balance, as the first $40 million of payments for this program will be made by Torii under the Company’s collaboration and license agreement.


Expense of $1.7 million was recognized during the quarter ended June 30, 2026, as an agreement in principle was reached to settle legal proceedings related to a class action brought against the Company in 2022. The expense represents Verrica’s share of the settlement after the insurance recovery.


Interest income was $0.1 million for the quarter ended June 30, 2026, compared to $0.2 million for the quarter ended June 30, 2025. The decrease in interest income was primarily due to lower cash balances.


Interest expense was $0.2 million for the quarter ended June 30, 2026, compared to $2.1 million for the same period in 2025. The decrease of $2.0 million was related to the settlement and termination of the Company’s OrbiMed debt facility in November 2025.

For the quarter ended June 30, 2026, net loss was $13.2 million, or $0.62 per share, compared to a net income of $0.2 million, or $0.02 per share, for the same period in 2025.


For the quarter ended June 30, 2026, non-GAAP net loss was $10.2 million, or $0.48 per share, compared to a non-GAAP net income of $1.2 million, or $0.12 per share, for the same period in 2025.

Year-to-date Financial Results


Product revenue, net was $9.4 million for the six months ended June 30, 2026, compared to $8.0 million for the six months ended June 30, 2025.


License and collaboration revenue was $1.5 million for the six months ended June 30, 2026, compared to $8.2 million for the six months ended June 30, 2025. License and collaboration revenue for the six months ended June 30, 2026 consisted of supplies and development activity with Torii. License and collaboration revenue for the six months ended June 30, 2025 consisted of a one-time $8.0 million milestone payment from Torii as well as supplies and development activity.


Costs of product revenue were $1.0 million for the six months ended June 30, 2026, compared to $0.8 million for the six months ended June 30, 2025.


Selling, general and administrative expenses were $20.3 million in the six months ended June 30, 2026, compared to $17.7 million for the same period in 2025. Excluding the impact of stock compensation, the increase of $2.6 million was primarily due to increased commercial spend related to the expansion of the sales force.


Research and development expenses were $9.9 million in the six months ended June 30, 2026, compared to $4.1 million for the same period in 2025. Excluding the impact of stock compensation, the increase of $5.6 million was primarily due to increased costs related to the Program for common warts.


Expense of $1.7 million was recognized during the six months ended June 30, 2026, as an agreement in principle was reached to settle legal proceedings related to a class action brought against the Company in 2022. The expense represents Verrica’s share of the settlement after the insurance recovery.


Interest income was $0.3 million for the six months ended June 30, 2026, compared to $0.6 million for the same period in 2025. The decrease of $0.3 million was primarily due to a lower cash balance.


Interest expense was $0.3 million for the six months ended June 30, 2026, and $4.3 million for the same period in 2025. The decrease of $4.0 million was related to the settlement of the OrbiMed Loan Facility and the termination of the OrbiMed Credit Agreement in November 2025.


For the six months ended June 30, 2026, net loss was $22.8 million, or $1.07 per share, compared to a net loss of $9.5 million, or $1.01 per share, for the same period in 2025.


For the six months ended June 30, 2026, non-GAAP net loss was $19.0 million, or $0.89 per share, compared to a non-GAAP net loss of $7.1 million, or $0.75 per share, for the same period in 2025.

(Press release, Verrica Pharmaceuticals, AUG 7, 2026, View Source [SID1234669876])

Soligenix Announces Recent Updates and Second Quarter 2026 Financial Results

On August 7, 2026 Soligenix, Inc. (Nasdaq: SNGX) (Soligenix or the Company), a biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, reported its recent updates and financial results for the quarter ended June 30, 2026.

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"While we were disappointed with the outcome of the Phase 3 FLASH2 clincial study that led to discontinuing the HyBryte (synthetic hypericin) development program, this outcome does not diminish the strength of our broader pipeline or the strategic value of Soligenix," stated Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix. "We remain focused on evaluating opportunities across our diversified portfolio, including the continued advancement of SGX945 (dusquetide) for Behçet’s disease, which demonstrated promising preliminary efficacy and was generally safe and well-tolerated in our Phase 2 study, as well as our ThermoVax heat-stable vaccine platform."

"With approximately $9.8 million in cash as of June 30, 2026, providing cash runway into the second quarter of 2028, we are well positioned to actively evaluate all strategic options to maximize stockholder value, including but not limited to partnerships, licensing opportunities, merger and acquisition opportunities, government grants and contracts, and the advancement of our existing pipeline. Maintaining our Nasdaq listing is also an important strategic asset that supports these efforts by preserving access to the public capital markets, enhancing our attractiveness to potential strategic partners and acquirers, and providing additional flexibility as we evaluate these opportunities. Consistent with this strategy, we are contuning to seek non-dilutive funding support for the development of our heat-stable Bundibugyo Ebola vaccine program from various sources, including the Coalition for Epidemic Preparedness Innovations (CEPI) and others."

Soligenix Recent Updates

On June 8, 2026, the Company announced that along with the University of Hawaiʻi at Mānoa, it would be applying for CEPI funding to develop a protein-based, thermostable vaccine targeting the Bundibugyo virus by leveraging the thermostability, immunogenicity, and efficacy data demonstrated with its filovirus vaccines. To view this press release, please click here.
On May 26, 2026, in response to a recent Bundibugyo virus outbreak in the Congo, the Company highlighted previous work with the University of Hawaiʻi, which has demonstrated platform compatibility with the key Bundibugyo virus antigen enabling rapid development of a protein-based thermostable subunit vaccine. To view this press release, please click here.
Financial Results – Quarter Ended June 30, 2026

Soligenix had no revenue for the quarter ended June 30, 2026 and 2025, respectively.

Soligenix’s net loss was $2.0 million, or ($0.12) per share, for the quarter ended June 30, 2026, compared to $2.7 million, or ($0.82) per share, for the same prior year period. This decrease in net loss was primarily due to a decrease in in research and development expenses associated with the terminated FLASH2 trial and related HyBryte development activities.

Research and development expenses were $1.0 million as compared to $1.7 million for the quarter ended June 30, 2026 and 2025, respectively. The decrease was primarily due to decreases in costs associated with the terminated FLASH2 trial and related HyBryte development activities.

General and administrative expenses were $1.1 million for the quarter ended June 30, 2026 as compared to $1.1 million for the same period in 2025, relatively flat with a de minimis increase.

As of June 30, 2026, the Company’s cash position was approximately $9.8 million.

(Press release, Soligenix, AUG 7, 2026, View Source [SID1234669875])