On August 4, 2026 Marengo Therapeutics, Inc., a clinical-stage biotechnology company pioneering precision immunotherapy approaches for cancer and autoimmune diseases, reported two important milestones reflecting the advancement of its TriSTAR platform: the nomination of the first development candidate under its TriSTAR strategic collaboration with Ipsen and the appointment of Saso Cemerski, Ph.D., as Senior Vice President, Head of Immunology.

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This drug candidate nomination marks the successful advancement of the first program developed through the strategic collaboration established by Marengo and Ipsen in June 2024. It is the second candidate from Marengo’s proprietary TriSTAR platform to enter IND-enabling development.

"Nominating a development candidate under our TriSTAR collaboration with Ipsen is a testament to the strength of our partnership and underscores the dedication and ingenuity of Marengo’s research team," said Zhen Su, M.D., MBA, Chief Executive Officer of Marengo Therapeutics. "Our first-in-class precision TriSTAR trispecific T-cell engagers are designed to deliver on the promise of precision immuno-oncology by bringing the right T cells to the right tumors. We look forward to continuing our work with Ipsen to translate this innovation into meaningful clinical benefit for patients."

TriSTAR is a precision "armed" T-cell engager platform with a differentiated two-in-one mechanism of action, combining selective T-cell activation and expansion with tumor-directed engagement in a single molecule. By integrating Vβ-directed T-cell activation, built-in costimulation and tumor-antigen targeting, TriSTAR candidates are designed to generate and redirect a new pool of highly active memory T cells against tumors. This precision approach has the potential to improve the therapeutic index of T-cell engagement by enhancing antitumor potency in solid tumors while limiting the broad, indiscriminate T-cell activation associated with traditional CD3-directed T-cell engagers.

This milestone demonstrates continued progress across the collaboration’s multiple programs and further validates the ability of the TriSTAR platform to repeatedly generate differentiated therapeutic candidates suitable for global clinical development. Marengo has led research and preclinical development for this program in partnership with Ipsen and is eligible for milestone payments under the collaboration. Ipsen will assume responsibility for all activities following development candidate nomination.

Appointment of Saso Cemerski, Senior Vice President, Head of Immunology

Building on this momentum, Marengo is strengthening its scientific leadership with the appointment of Dr. Cemerski, an industry-leading expert in T-cell engager discovery and immune-cell activation Dr. Cemerski will lead immunology research across Marengo’s clinical and preclinical portfolio, help shape the company’s scientific strategy and accelerate expansion of its pipeline of precision Vβ-directed T-cell therapies.

"Saso is one of the industry’s foremost experts in T-cell engager discovery and immune-cell activation.," Dr. Su continued. "His experience building global research organizations and advancing multiple programs toward the clinic makes him uniquely suited to help us realize the full potential of TriSTAR. His appointment significantly strengthens our ability to expand what we believe is one of the industry’s most differentiated pipelines of precision Vβ-directed T-cell engagers."

"Marengo has built an exceptionally innovative immunology platform with the potential to redefine how T-cell engagers activate and redirect the immune system," said Saso Cemerski, Ph.D., Senior Vice President, Head of Immunology at Marengo Therapeutics. "The unique biology of selective Vβ T-cell activation creates an opportunity to overcome many of the limitations of existing T-cell engager approaches. I am excited to join this outstanding team and help translate the TriSTAR platform into a broad pipeline of next-generation therapies for patients."

Dr. Cemerski brings more than 15 years of experience leading immunology research and therapeutic discovery across biotechnology and pharmaceutical companies. Most recently, he served as Head of Discovery Immune Cell Engagement at AstraZeneca, where he led a global organization of more than 75 scientists, advanced multiple discovery programs toward clinical development, and helped evaluate and integrate externally sourced T-cell engager technologies. His prior experience includes a senior leadership role at Cue Biopharma, as well as positions at Merck, Bristol Myers Squibb and Xencor, where he contributed to the advancement of multiple antibody and small molecule therapeutics from discovery through clinical development.

(Press release, Marengo Therapeutics, AUG 4, 2026, View Source [SID1234669675])

On August 4, 2026 Labcorp (NYSE: LH), a global leader of innovative and comprehensive laboratory services, reported the nationwide availability of Roche’s VENTANA PTEN (SP218) RxDx Assay, the first immunohistochemistry (IHC) companion diagnostic test approved by the U.S. Food and Drug Administration (FDA) to determine PTEN protein loss, also known as PTEN deficiency, in tumors of patients with prostate adenocarcinoma. The assay helps identify patients who may be eligible for treatment with AstraZeneca’s TRUQAP (capivasertib) in combination with abiraterone acetate and prednisone.

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Addressing an Unmet Need in Prostate Cancer Care
Excluding skin cancer, prostate cancer is the most common cancer among men in the United States, with more than 330,000 new cases expected each year. PTEN is a tumor suppressor protein that plays a critical role in regulating cell growth. Loss of PTEN protein expression has been associated with more aggressive disease progression and reduced benefit from current standard-of-care therapies in prostate cancer. Until recently, there were no approved treatment options specifically targeting this biology.

The VENTANA PTEN (SP218) RxDx Assay is a companion diagnostic designed to detect PTEN protein loss in prostate cancer tissue specimens, providing clinicians with important biomarker information to help guide treatment decisions and support personalized patient care.

"Biomarker testing is essential to advancing precision oncology and helping connect patients with the therapies most appropriate for their disease," said Shakti Ramkissoon, M.D., Ph.D., vice president, medical lead for oncology at Labcorp. "The launch of the VENTANA PTEN (SP218) RxDx Assay underscores how Labcorp is expanding access to innovative companion diagnostics and delivering the timely insights physicians need to make personalized treatment decisions."

Advancing Access to FDA-Approved Companion Diagnostics
Labcorp participated in Roche’s early access program to support Day 1 laboratory readiness for the assay, reinforcing the company’s commitment to helping patients gain timely access to newly approved targeted therapies and the companion diagnostics needed to identify eligible patients.

The VENTANA PTEN (SP218) RxDx Assay is now available through Labcorp’s national network of laboratories and complements the company’s comprehensive portfolio of genomic, molecular and companion diagnostic testing services that support precision oncology care. As one of the nation’s largest providers of oncology testing services, Labcorp enables physicians across community and academic settings to access FDA-approved companion diagnostics at scale, helping bring precision medicine to more patients regardless of where they receive care. The assay can also be ordered alongside Labcorp’s broader portfolio of oncology testing services, providing clinicians with comprehensive biomarker insights from a single laboratory partner.

To learn more about the assay, visit View Source

(Press release, LabCorp, AUG 4, 2026, View Source [SID1234669674])

On August 4, 2026 Nuvation Bio Inc. (NYSE: NUVB), a global oncology company focused on tackling some of the toughest challenges in cancer treatment, reported that new analyses of long-term Phase 2 TRUST-I and TRUST-II data will be presented at the IASLC 2026 World Conference on Lung Cancer (WCLC) taking place September 12–15, 2026, in Seoul, South Korea, and at the European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress (ESMO) (Free ESMO Whitepaper) October 23–27, 2026, in Madrid, Spain. These findings from the pivotal Phase 2 studies will feature the efficacy and safety of IBTROZI (taletrectinib) for the treatment of adult patients with locally advanced or metastatic ROS1-positive (ROS1+) non-small cell lung cancer (NSCLC) across key patient subgroups.

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"Every patient has a unique treatment journey, and physicians need confidence that a therapy can deliver consistent, long-term benefit across a broad range of patients," said David Hung, M.D., Founder, President and Chief Executive Officer of Nuvation Bio. "At WCLC and ESMO (Free ESMO Whitepaper), we look forward to presenting subgroup analyses of our pivotal data, including for patients previously treated with earlier-generation ROS1 inhibitors, that will further underscore the durable clinical benefits of IBTROZI demonstrated in our long-term data and reinforce its potential as a standard of care across all lines of advanced ROS1-positive NSCLC."

Presentations Overview:

WCLC

Title: Taletrectinib Across Key Subgroups in Patients With ROS1+ Non-Small Cell Lung Cancer: Results From TRUST-I and TRUST-II

Presenter: Hidetoshi Hayashi, Kindai University Faculty of Medicine, Osaka, Japan

Date: Tuesday, September 15, 2026

Session Time: 9:30-11:00 a.m. KST

ESMO

Title: Updated Efficacy and Safety of Taletrectinib in Patients with Advanced ROS1+ Non-Small Cell Lung Cancer (NSCLC) After Prior Entrectinib Exposure: Results from the Global TRUST-II Study

Presenter: Maurice Pérol, Department of Medical Oncology, Léon Bérard Cancer Center, Lyon, France

Date: Monday, October 26, 2026

Session Time: 12:00-12:45 p.m. CEST

The materials will be made available in the Publications section of Nuvation Bio’s website after the presentations. To meet representatives from Nuvation Bio, visit Booth #115 at WCLC and Booth #1080 at ESMO (Free ESMO Whitepaper).

About ROS1+ NSCLC
Each year, more than one million people globally are diagnosed with non-small cell lung cancer (NSCLC), the most common form of lung cancer. It is estimated that approximately 2% of patients with NSCLC have ROS1+ disease. About 35% of patients newly diagnosed with metastatic ROS1+ NSCLC have tumors that have spread to their brain. The brain is also the most common site of disease progression, with about 50% of previously treated patients developing central nervous system (CNS) metastases.

About IBTROZI
IBTROZI is an oral, potent, CNS-active, selective, next-generation ROS1 inhibitor therapy. On June 11, 2025, following Priority Review and Breakthrough Therapy designations for both TKI-naive and TKI-pretreated disease, the U.S. Food and Drug Administration (FDA) approved taletrectinib for the treatment of adult patients with locally advanced or metastatic ROS1+ NSCLC. Learn more about taletrectinib in the U.S. at IBTROZI.com.

About the TRUST Clinical Program
The TRUST clinical program comprises three registrational studies evaluating the safety and efficacy of IBTROZI. TRUST-I (NCT04395677) and TRUST-II (NCT04919811) are Phase 2 single-arm studies evaluating IBTROZI for the treatment of adults with advanced ROS1+ NSCLC in China (N=173) and globally (N=189), respectively. The primary endpoint of both studies is confirmed objective response rate (cORR) as assessed by an independent review committee. TRUST-IV (NCT07154706) is a Phase 3 placebo-controlled study evaluating IBTROZI for the adjuvant treatment of adults with resected early-stage ROS1+ NSCLC. The study will enroll approximately 180 patients in the U.S., Canada, Europe, Japan and China. The primary endpoint is disease-free survival as determined by investigator, and the primary completion date is estimated to be in 2030. Nuvation Bio is also sponsoring TRUST-III (NCT06564324), a confirmatory randomized Phase 3 study evaluating IBTROZI versus crizotinib in 194 patients in China with advanced ROS1+ NSCLC who have not previously received ROS1 TKIs.

U.S. Indication
IBTROZI is indicated for the treatment of adult patients with locally advanced or metastatic ROS1+ non-small cell lung cancer (NSCLC).

IMPORTANT SAFETY INFORMATION FOR IBTROZI (taletrectinib)

WARNINGS AND PRECAUTIONS

Hepatotoxicity: Hepatotoxicity, including drug-induced liver injury and fatal adverse reactions, can occur. 88% of patients experienced increased AST, including 10% Grade 3/4. 85% of patients experienced increased ALT, including 13% Grade 3/4. Fatal liver events occurred in 0.6% of patients. Median time to first onset of AST or ALT elevation was 15 days (range: 3 days to 20.8 months).

Increased AST or ALT each led to dose interruption in 7% of patients and dose reduction in 5% and 9% of patients, respectively. Permanent discontinuation was caused by increased AST, ALT, or bilirubin each in 0.3% and by hepatotoxicity in 0.6% of patients.

Concurrent elevations in AST or ALT ≥3 times the ULN and total bilirubin ≥2 times the ULN, with normal alkaline phosphatase, occurred in 0.6% of patients.

Interstitial Lung Disease (ILD)/Pneumonitis: Severe, life-threatening, or fatal ILD or pneumonitis can occur. ILD/pneumonitis occurred in 2.3% of patients, including 1.1% Grade 3/4. One fatal ILD case occurred at the 400 mg daily dose. Median time to first onset of ILD/pneumonitis was 3.8 months (range: 12 days to 11.8 months).

ILD/pneumonitis led to dose interruption in 1.1% of patients, dose reduction in 0.6% of patients, and permanent discontinuation in 0.6% of patients.

QTc Interval Prolongation: QTc interval prolongation can occur, which can increase the risk for ventricular tachyarrhythmias (e.g., torsades de pointes) or sudden death. IBTROZI prolongs the QTc interval in a concentration-dependent manner.

In patients who received IBTROZI and underwent at least one post baseline ECG, QTcF increase of >60 msec compared to baseline and QTcF >500 msec occurred in 13% and 2.6% of patients, respectively. 3.4% of patients experienced Grade ≥3. Median time from first dose of IBTROZI to onset of ECG QT prolongation was 22 days (range: 1 day to 38.7 months). Dose interruption and dose reduction each occurred in 2.8% of patients.

Significant QTc interval prolongation may occur when IBTROZI is taken with food, strong and moderate CYP3A inhibitors, and/or drugs with a known potential to prolong QTc. Administer IBTROZI on an empty stomach. Avoid concomitant use with strong and moderate CYP3A inhibitors and/or drugs with a known potential to prolong QTc.

Hyperuricemia: Hyperuricemia can occur and was reported in 14% of patients, with 16% of these requiring urate-lowering medication without pre-existing gout or hyperuricemia. 0.3% of patients experienced Grade ≥3. Median time to first onset was 2.1 months (range: 7 days to 35.8 months). Dose interruption occurred in 0.3% of patients.

Myalgia with Creatine Phosphokinase (CPK) Elevation: Myalgia with or without CPK elevation can occur. Myalgia occurred in 10% of patients. Median time to first onset was 11 days (range: 2 days to 10 months).

Concurrent myalgia with increased CPK within a 7-day time period occurred in 0.9% of patients. Dose interruption occurred in 0.3% of patients with myalgia and concurrent CPK elevation.

Skeletal Fractures: IBTROZI can increase the risk of fractures. ROS1 inhibitors as a class have been associated with skeletal fractures. 3.4% of patients experienced fractures, including 1.4% Grade 3. Some fractures occurred in the setting of a fall or other predisposing factors. Median time to first onset of fracture was 10.7 months (range: 26 days to 29.1 months). Dose interruption occurred in 0.3% of patients.

Embryo-Fetal Toxicity: Based on literature, animal studies, and its mechanism of action, IBTROZI can cause fetal harm when administered to a pregnant woman.

ADVERSE REACTIONS
Among patients who received IBTROZI, the most frequently reported adverse reactions (≥20%) were diarrhea (64%), nausea (47%), vomiting (43%), dizziness (22%), rash (22%), constipation (21%), and fatigue (20%).

The most frequently reported Grade 3/4 laboratory abnormalities (≥5%) were increased ALT (13%), increased AST (10%), decreased neutrophils (5%), and increased creatine phosphokinase (5%).

DRUG INTERACTIONS

Strong and Moderate CYP3A Inhibitors/CYP3A Inducers and Drugs that Prolong the QTc Interval: Avoid concomitant use.
Gastric Acid Reducing Agents: Avoid concomitant use with PPIs and H2 receptor antagonists. If an acid-reducing agent cannot be avoided, administer locally acting antacids at least 2 hours before or 2 hours after taking IBTROZI.
OTHER CONSIDERATIONS

Pregnancy: Please see important information in Warnings and Precautions under Embryo-Fetal Toxicity.
Lactation: Advise women not to breastfeed during treatment and for 3 weeks after the last dose.
Effect on Fertility: Based on findings in animals, IBTROZI may impair fertility in males and females. The effects on animal fertility were reversible.
Pediatric Use: The safety and effectiveness of IBTROZI in pediatric patients has not been established.
Photosensitivity: IBTROZI can cause photosensitivity. Advise patients to minimize sun exposure and to use sun protection, including broad-spectrum sunscreen, during treatment and for at least 5 days after discontinuation.

(Press release, Nuvation Bio, AUG 4, 2026, View Source [SID1234669673])

On August 4, 2026 Tyra Biosciences, Inc. (Nasdaq: TYRA), a clinical-stage biotechnology company focused on developing next-generation precision medicines that target large opportunities in Fibroblast Growth Factor Receptor (FGFR) biology, reported financial results for the second quarter ended June 30, 2026, and highlighted recent corporate progress.

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"September marks an important milestone for TYRA as we prepare to share initial clinical data from SURF302 evaluating oral dabogratinib in intermediate-risk non-muscle invasive bladder cancer (IR NMIBC). Patients with IR NMIBC often endure a lifelong cycle of recurrent disease, repeated surgical procedures, catheterization, and ongoing surveillance, highlighting the need for more convenient and effective treatment options. We believe dabogratinib has the potential to redefine the treatment paradigm as the first targeted oral therapy for FGFR3-driven IR NMIBC, addressing the underlying biology of the disease while offering the convenience of an oral therapy," said Todd Harris, PhD, President and Chief Executive Officer of TYRA.

Dr. Harris continued, "Beyond SURF302, we continue to advance our broader pipeline, including progressing BEACH301 to a fifth dose level in achondroplasia, and strengthening our skeletal dysplasia leadership with the addition of Jonathan Day, whose work was instrumental in the development of vosoritide. Across our portfolio, we remain focused on realizing the full potential of oral dabogratinib for patients with FGFR3-driven conditions and diseases."

"Over the past decade, I’ve had the privilege of helping advance therapies that have transformed the treatment landscape for children with achondroplasia. I believe there is still meaningful opportunity to further improve outcomes, and TYRA’s highly selective approach to FGFR3 inhibition offers a compelling opportunity to do just that," commented Dr. Day, TYRA’s newly appointed Executive Vice President, Clinical Development. "I’m excited to join the team and help advance dabogratinib as we work to develop a differentiated oral therapy for children with achondroplasia and their families."

Second Quarter and Recent Corporate Highlights

Dabogratinib 3×3 Strategy

In the second quarter of 2026, TYRA continued to advance its "dabogratinib 3×3" strategy: developing the first orally available, FGFR3-selective inhibitor in 3 future potentially pivotal clinical studies to support regulatory submissions with the aim to commercialize in 3 potential blockbuster indications: LG-UTUC, IR NMIBC and ACH.

Phase 2 LG-UTUC Study – SURF303. SURF303 is a Phase 2a/b, multicenter, open-label study designed with pivotal intent to evaluate the efficacy and safety of oral dabogratinib at two QD doses (60 mg and 80 mg) in participants with low-grade upper tract urothelial carcinoma (LG-UTUC), a rare cancer where approximately 85% of tumors are driven by FGFR3. Initial results from this study are expected in 2027.
Phase 2 IR NMIBC Study – SURF302. SURF302 is a Phase 2, multicenter, open-label clinical study evaluating the efficacy and safety of oral dabogratinib at two QD doses (50 mg and 60 mg) in participants with FGFR3-altered low-grade IR NMIBC. The Company will host a conference call and webcast in September 2026 to report initial results from the SURF302 study, including safety results from more than 40 patients and efficacy from more than 20 patients in the aggregate at both QD dose levels.
Phase 2 ACH Study – BEACH301. BEACH301 is a Phase 2, multicenter, open-label, dose-escalation/dose-expansion study evaluating oral dabogratinib in children ages 3 to 10 with achondroplasia (ACH). The study has enrolled the safety sentinel cohort and successfully cleared four dose levels, with no notable safety events reported to date. Given the favorable safety profile seen to date across dose levels 1 through 4 in BEACH301, the Data Safety Monitoring Committee authorized the opening of a fifth dose level to evaluate 0.625 mg/kg in the safety sentinel cohort. Initial results from the safety sentinel cohort, including 6-month annualized height velocity and safety data for dose levels 1-5, which will include an aggregate of approximately 25 children, are expected to be reported at the end of Q1 2027.
Corporate

Appointed Jonathan Day as EVP, Clinical Development for Skeletal Dysplasia Conditions. In June 2026, TYRA appointed Jonathan Day, MBBS, PhD, FFPM, FESC, as Executive Vice President, Clinical Development, where he will lead the Company’s development program and clinical strategy for oral dabogratinib in skeletal dysplasia conditions. Dr. Day is a physician-scientist and pharmaceutical executive with extensive experience leading late-stage clinical development programs in rare diseases. At BioMarin Pharmaceutical, he served as Head of R&D for the Skeletal Conditions Business Unit (previously Group Vice President, Late-Stage Clinical Development), where he led the global clinical development strategy for the company’s skeletal dysplasia portfolio, including vosoritide (Voxzogo) for achondroplasia. Before joining BioMarin, Dr. Day was Vice President and Global Medical Lead for Acute Cardiovascular Care at The Medicines Company, and earlier served as Medical Director for the UK & Ireland at AstraZeneca. Prior to industry, he trained in cardiothoracic surgery and completed a PhD at Imperial College London focused on thrombin inhibition and cardiovascular medicine. He is also a Fellow of the European Society of Cardiology and the Faculty of Pharmaceutical Medicine.
Amended ATM Sales Agreement. In August 2026, TYRA entered into an amended sales agreement with TD Securities (USA) LLC, under which TYRA may sell up to the amount registered on an effective registration statement under which the offering is made, subject to other limitations. Pursuant to the amended sales agreement, as of the date hereof, TYRA may sell an additional $250.0 million of shares of its common stock from time to time in "at-the-market" offerings.
SNÅP Platform and Pipeline

TYRA continued to advance its in-house precision medicine discovery engine, SNÅP, used to develop therapies in targeted oncology and genetically defined conditions.
Second Quarter Financial Results

Cash, Cash Equivalents and Marketable Securities. As of June 30, 2026, TYRA had cash, cash equivalents and marketable securities of $353.9 million. The Company’s current cash, cash equivalents and marketable securities are expected to allow TYRA to execute on its plans into the second half of 2028.
Research and Development (R&D) Expenses. R&D expenses for the three months ended June 30, 2026 were $39.2 million compared to $24.3 million for the same period in 2025. The increase was primarily associated with development activities for oral dabogratinib, supporting the ongoing SURF303, SURF302 and BEACH301 clinical trials, partially offset by a decrease in development activities for other programs. There were also increases in personnel expenses, driven by headcount growth to support expanding clinical and development activities, and expenses for facilities and other costs.
General and Administrative (G&A) Expenses. G&A expenses for the three months ended June 30, 2026 were $9.8 million compared to $7.1 million for the same period in 2025. The increase was primarily driven by higher compensation and other personnel costs, driven by headcount growth.
Net Loss. Second quarter net loss was $45.6 million compared to $28.1 million for the same period in 2025.
Upcoming Anticipated Clinical Milestones:

SURF303: initial results – 2027
SURF302: initial results from both dose cohorts – September 2026
BEACH301: initial results from dose levels 1-5 of safety sentinel cohort – end of Q1 2027
About Dabogratinib (formerly TYRA-300)

Dabogratinib is TYRA’s lead precision medicine candidate stemming from its in-house SNÅP platform. Dabogratinib is an investigational, oral, FGFR3-selective inhibitor currently in Phase 2 development for the treatment of urologic cancers and skeletal dysplasias, specifically LG-UTUC, IR NMIBC and ACH. We believe dabogratinib was the first orally available, FGFR3-selective inhibitor to enter clinical development, and it has been studied in more than 200 individuals to date across multiple clinical and healthy volunteer studies.

Oral dabogratinib is currently advancing in three Phase 2 clinical trials for LG-UTUC (SURF303), IR NMIBC (SURF302), and ACH (BEACH301). The FDA has granted Orphan Drug Designation and Rare Pediatric Disease Designation to oral dabogratinib for the treatment of achondroplasia.

Please visit the Patients page of our website for more information on our clinical trials.

(Press release, Tyra Biosciences, AUG 4, 2026, View Source [SID1234669672])

On August 4, 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 financial results for the quarter ended June 30, 2026, and highlighted recent corporate accomplishments and 2026 milestones.

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"Our combination with Sensei Biotherapeutics marked an important milestone in the history of Faeth Therapeutics," said Anand Parikh, Chief Executive Officer. "With the concurrent $200 million PIPE financing, we now have the capital to interrogate the multi-nodal hypothesis in multiple cancers. We look forward to reading out topline data from our Phase 2 PIK-201 trial in endometrial cancer, which is expected by year-end."

Mr. Parikh continued, "We are also excited to have expanded development of PIKTOR into its second indication with the first patient dosed in our PIK-101 trial in HR+ breast cancer in April. We look forward to reporting initial safety and efficacy data from PIK-101 in 2027."

Recent Corporate Updates:

In April, the Company dosed the first patient in its Phase 1b/2 Trial of PIKTOR in HR+/HER2- Advanced Breast Cancer
In June, stockholders approved the conversion of the Series B preferred stock issued in the February 2026 acquisition of Faeth Therapeutics and concurrent private placement into common stock
In June, the Company changed its name to Faeth Therapeutics, Inc. and began trading under the ticker symbol "FTH"
In June, Anand Parikh, Faeth co-founder, was appointed Chairman, President and Chief Executive Officer, and Brian Stephenson, Ph.D., CFA was appointed Chief Financial Officer. Additionally, the board was strengthened with the addition of former FDA Commissioner Stephen M. Hahn, M.D., and Saira Ramasastry.
Second Quarter 2026 Financial Results

Cash, Cash Equivalents and Marketable Securities: Cash, cash equivalents and marketable securities were $186.4 million as of June 30, 2026, as compared to $21.2 million as of December 31, 2025.
Research and Development Expenses (R&D): R&D expenses for the quarter ended June 30, 2026 were $9.2 million, compared to $2.5 million for the quarter ended June 30, 2025. The increase in R&D expenses was primarily driven by clinical trial and manufacturing (CMC) costs supporting the development of PIKTOR, together with higher personnel costs, partially offset by lower clinical trial costs for SNS-101.
General and Administrative Expenses (G&A): G&A expenses for the quarter ended June 30, 2026, were $9.2 million, compared to $2.7 million during the quarter ended June 30, 2025. The increase in G&A expense was primarily attributable to increased personnel costs and increased professional fees related to financing and reporting activities.
Net Loss: Net loss was $16.0 million, or $2.84 per basic and diluted share, for the quarter ended June 30, 2026, compared with a net loss of $4.9 million, or $3.91 per basic and diluted share, for the quarter ended June 30, 2025.

Weighted-average common shares outstanding, basic and diluted, were 5,643,222 for the quarter ended June 30, 2026, compared with 1,260,867 for the quarter ended June 30, 2025.

Condensed Statements of Operations
(Unaudited, in thousands except share and per share data)

For the Three Months
Ended June 30,

2026

2025

Operating expenses:
Research and development
$

9,180

$

2,533

General and administrative

9,205

2,673

Total operating expenses

18,385

5,206

Loss from operations

(18,385

)

(5,206

)

Total other income

2,378

270

Net loss

(16,007

)

(4,936

)

Net loss per share, basic and diluted
$

(2.84

)

$

(3.91

)

Weighted-average common shares outstanding, basic and diluted

5,643,222

1,260,867

Selected Condensed Balance Sheet Data
(Unaudited, in thousands)

June 30,
2026 December 31,
2025
Cash and cash equivalents
$

26,903

$

8,668

Marketable securities

159,538

12,516

Total assets

189,306

22,902

Total liabilities

9,581

4,310

Series B redeemable convertible preferred stock

6,767

—

Total stockholders’ equity

172,958

18,592

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 in the second half of 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 4, 2026, View Source [SID1234669671])