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])

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])

On August 7, 2026 GRAIL, Inc. (Nasdaq: GRAL), a healthcare company whose mission is to detect cancer early when it can be cured, reported that the U.S. Food and Drug Administration’s (FDA) Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee is scheduled to meet on Sept. 23, 2026 to review the Premarket Approval (PMA) application for the Galleri multi-cancer early detection (MCED) blood test.

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The Galleri test is designed to detect cancer-specific methylation patterns shared by many types of cancer before symptoms appear, including cancers that do not have recommended screening today. When a cancer signal is detected, Galleri is designed to predict the cancer signal origin with high accuracy to help guide diagnostic evaluation. The test is intended to be used in addition to, and not as a replacement for, guideline-recommended screenings.

"Today, the status quo in cancer screening is simply unacceptable. Many cancers are detected too late, after symptoms appear and the disease is too advanced for effective or curative-intent treatments. In fact, 70-80% of cancer deaths occur due to cancers we are not screening for at all. GRAIL has pioneered a breakthrough technology, the Galleri test, designed to transform cancer screening by detecting more cancers before symptoms appear, including many of the deadly cancers that lack recommended screenings today. The Galleri technology is unique in how it is designed to examine the methylome using proprietary technology and artificial intelligence. We have generated extensive data in multiple studies to evaluate the impact of adding Galleri to standard of care screening with positive results showing evidence of increases in screen detected cancers, a low false positive rate and high signal origin prediction accuracy. Adding Galleri to recommended screening could result in a more effective and efficient cancer screening program in the U.S.," said Josh Ofman, MD, MSHS, CEO at GRAIL. "Galleri is the only MCED test supported by large interventional and randomized, controlled studies in intended use populations. We appreciate the FDA’s leadership in advancing the review of the first premarket approval application for an MCED, and we look forward to discussing Galleri’s clinical data and the opportunity for multi-cancer early detection to address a significant unmet public health need, with the Advisory Committee."

GRAIL submitted its PMA application for Galleri to the FDA on Jan. 29, 2026. The FDA designated Galleri as a Breakthrough Device in 2018. The PMA submission is focused on the test performance and safety results from 25,490 consented participants with one year of follow up in the US-based PATHFINDER 2 study as well as data from over 70,000 participants from the intervention arm of the prevalent screening round (first year) of the NHS-Galleri trial, the largest and only randomized, controlled trial of an MCED test in an intended use population. The submission is also supported by an analysis to compare performance of the version of Galleri used in the PATHFINDER 2 study and the NHS-Galleri trial to the updated PMA version that has been submitted to the FDA for premarket approval.

(Press release, Grail, AUG 7, 2026, View Source [SID1234669881])

On August 7, 2026 Atossa Therapeutics, Inc. (Nasdaq: ATOS) (Atossa or the Company), a clinical-stage biopharmaceutical company developing novel therapies in oncology and other areas of high unmet clinical need, reported its financial results and provided an update on recent corporate developments for the second quarter ended June 30, 2026.

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"During the quarter, we executed well across the business," stated Dr. Steven Quay, M.D., Ph.D., Atossa Therapeutics’ President and Chief Executive Officer. "We continued to advance the scientific rationale for (Z)-endoxifen’s potential in rare pediatric diseases, such as Duchenne Muscular Dystrophy and McCune-Albright Syndrome, while also strengthening its clinical and scientific foundation in breast cancer, all through new data presented at important industry conferences, including ASCO (Free ASCO Whitepaper) and AACR (Free AACR Whitepaper), as well as publications in well-regarded peer-reviewed journals, Degenerative Neurological and Neuromuscular Disease and npj Breast Cancer."

Dr. Quay continued, "These accomplishments, together with additional capital from our registered direct offering, underscore the breadth of potential we see for (Z)-endoxifen, and investors’ support in our ability to continue advancing our programs."

Second Quarter 2026 & Recent Highlights

Rare Diseases

Atossa Participated at the 2026 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Special Conference in Cancer Research: Cancer Evolution

In a poster presentation titled, "Dual estrogen receptor and PKC-β signaling modulation by (Z)-Endoxifen: A mechanism-driven therapeutic strategy for estrogen-driven pathology in McCune-Albright Syndrome," the Company discussed a dual mechanism of action for (Z)-endoxifen in estrogen-driven pathology relevant to McCune-Albright Syndrome-associated Peripheral Precocious Puberty (MAS-PPP).

The dual mechanism includes the blockade of estrogen receptor (ER)-mediated transcription downstream of autonomous estrogen production and suppression of PKC-β/AKT-associated proliferative and cell-cycle signaling.

This multi-pathway profile may address a key therapeutic gap in MAS-PPP, where estrogen suppression alone may not fully mitigate downstream proliferative signaling.

The Company previously received Rare Pediatric Disease (RPD) designation for (Z)-endoxifen from the U.S. Food and Drug Administration (FDA) for (Z)-endoxifen for the treatment of McCune-Albright Syndrome (MAS).

The Company Announced Acceptance of Manuscript Highlighting the Utrophin-Modulation Potential of (Z)-Endoxifen in Duchenne Muscular Dystrophy (DMD)

A paper details how (Z)-endoxifen may support the expression of utrophin, a paralog of dystrophin. (Z)-Endoxifen therefore represents a potential dystrophin mutation-agnostic treatment for DMD. The paper citation is: Remmel HL, Hammer SS, Blackburn SM, Quay SC. (Z)-Endoxifen as a Potential Modulator of Utrophin Pathways in Duchenne Muscular Dystrophy: A Mechanistic and Transcriptomic Perspective. Degener Neurol Neuromuscular Dis. 2026;16:574524 View Source

The results support further investigation of (Z)-endoxifen in dystrophin-deficient models, as well as biomarker development. These data also build upon the Company’s previously published manuscript, "A Hypothesized Therapeutic Role of (Z)-Endoxifen in Duchenne Muscular Dystrophy," also published in Degenerative Neurological and Neuromuscular Disease.

The Company previously received Orphan Drug Designation (ODD) and RPD designation for (Z)-endoxifen from the FDA for the treatment of DMD.
Oncology

The Company Published Manuscript Highlighting the Anti-cancer Activity of (Z)-Endoxifen-related Compounds

In the peer-reviewed journal, npj Breast Cancer, the Company published an article titled, "Novel (Z)-endoxifen-related new chemical entities exhibit potent anti-cancer activity in ERα+ breast cancer."

The investigators evaluated five previously uncharacterized compounds generated during the synthesis of (Z)-endoxifen, alongside (Z)-endoxifen in a broad panel of laboratory assays, as well as in combination with the CDK4/6 inhibitor abemaciclib.

The publication reported anti-estrogenic and anti-cancer activity across multiple ER-positive (ER+) breast cancer models, including models harboring clinically relevant activating mutations in ESR1.

In certain experimental settings and models, selected compounds combined with abemaciclib demonstrated additive to synergistic activity that was comparable to or greater than the activity observed with abemaciclib plus (Z)-endoxifen.

The authors concluded that select compounds warrant further in vivo safety evaluation, as well as efficacy studies, including as potential second- or third-line approaches for recurrent disease.

Atossa Participated in the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting

In a poster presentation titled, "A Phase 2 Clinical Trial in Progress of (Z)-Endoxifen Plus Goserelin as Neoadjuvant Therapy in Premenopausal Women With ER+/HER2- Breast Cancer (EVANGELINE)," the Company described EVANGELINE (NCT05607004), an ongoing, multicenter, open-label Phase 2 study evaluating daily 40 mg (Z)-endoxifen plus goserelin administered every 28 days as neoadjuvant therapy in premenopausal women with ER+/human epidermal growth factor receptor 2 negative (HER2-), cT2-3, cN0-1 breast cancer. Enrollment in this study was completed as of June 30, 2026.

In an online publication titled, "Effect of (Z)-endoxifen Demonstrates Robust Estrogen Receptor Signaling Inhibition Across Clinically Relevant ESR1 Mutations," the Company highlighted new preclinical data demonstrating that (Z)-endoxifen delivers robust ER inhibition across clinically relevant estrogen receptor alpha gene (ESR1) mutations. ESR1 mutations are a major mechanism of acquired endocrine resistance in ER-positive breast cancer and remain associated with limited treatment options despite the emergence of next-generation endocrine therapies. These data support the ongoing clinical development of (Z)-endoxifen, as well as its potential as a promising treatment option for breast cancer patients with limited therapeutic alternatives.
Corporate

Atossa Strengthened its Balance Sheet with a Registered Direct Offering, Potentially Providing Up to $16.5 Million in Gross Proceeds

The Company entered into a securities purchase agreement with institutional investors, which provided for the issuance and sale by the Company, in a registered direct offering of (i) 1,363,637 shares of the Company’s common stock and (ii) Series A warrants to purchase up to 1,363,637 shares of common stock and short-term Series B warrants to purchase up to 1,363,637 shares of common stock, raising $4.5 million in upfront gross proceeds, with the potential to receive up to an additional $12 million, assuming the full cash exercise of the warrants. Net proceeds are designated to support the clinical development of (Z)-endoxifen and for general corporate working capital.
Financial Results for the Second Quarter Ended June 30, 2026

Operating Expenses. Total operating expenses were $8.7 million and $18.6 million for the three and six months ended June 30, 2026, respectively, which was a decrease of $0.3 million and an increase of $2.1 million from total operating expenses for the three and six months ended June 30, 2025 of $9.0 million and $16.5 million, respectively. Factors contributing to the changes in operating expenses during the three and six months ended June 30, 2026 are explained below.

Research & Development (R&D) Expenses. The following table provides a breakdown of major categories within R&D expenses for the three and six months ended June 30, 2026 and 2025, together with the dollar change and percentage change in those categories (dollars in thousands):

For the Three Months Ended June 30,

For the Six Months Ended June 30,

2026

2025

Increase (Decrease)

% Increase (Decrease)

2026

2025

Increase (Decrease)

% Increase (Decrease)

Research and Development Expense

Clinical and non-clinical trials

$

3,525

$

4,089

$

(564)

(14) %

$

7,243

$

6,836

$

407

6 %

Compensation

954

856

98

11 %

1,888

1,736

152

9 %

Professional fees and other

418

557

(139)

(25) %

545

1,087

(542)

(50) %

Research and Development Expense Total

$

4,897

$

5,502

$

(605)

(11) %

$

9,676

$

9,659

$

17

0 %

As (Z)-endoxifen is our only product candidate for which we currently incur R&D expenses, we have not further disaggregated R&D expenses by product candidate:

Clinical and non-clinical trial expenses decreased $0.6 million for the three months ended June 30, 2026, compared to the three months ended June 30, 2025, primarily due to a decrease of $1.0 million in spend on preclinical trials that concluded in the prior period, partially offset by an increase in expense due to higher enrollment in clinical trials of $0.2 million and an increase in drug development costs of $0.3 million in the current period. Clinical and non-clinical trial expenses increased $0.4 million for the six months ended June 30, 2026, compared to the six months ended June 30, 2025, due to an increase in expense related to clinical trial enrollments of $1.5 million and an increase in drug development costs of $0.7 million, partially offset by a $1.8 million decrease in expenses related to preclinical work completed in 2025.
The increase in R&D compensation expenses of $0.1 million and $0.2 million for the three and six months ended June 30, 2026, respectively, compared to the three and six months ended June 30, 2025, was due primarily to increases in non-cash stock-based compensation expense of $0.1 million.
The decrease in R&D professional fees and other of $0.1 million and $0.5 million for the three and six months ended June 30, 2026, respectively, compared to the three and six months ended June 30, 2025, was primarily attributable to a decrease in regulatory consulting fees in the 2026 periods related to our (Z)-endoxifen program as compared to the same periods in the prior year.
General and Administrative (G&A) Expenses. The following table provides a breakdown of major categories within G&A expenses for the three and six months ended June 30, 2026 and 2025, together with the dollar change and percentage change in those categories (dollars in thousands):

For the Three Months Ended June 30,

For the Six Months Ended June 30,

2026

2025

Increase (Decrease)

% Increase
(Decrease)

2026

2025

Increase (Decrease)

% Increase
(Decrease)

General and Administrative Expense

Compensation

$

1,248

$

1,564

$

(316)

(20) %

$

2,559

$

3,026

$

(467)

(15) %

Professional fees and other

2,549

1,974

575

29 %

6,329

3,769

2,560

68 %

General and Administrative Expense
Total

$

3,797

$

3,538

$

259

7 %

$

8,888

$

6,795

$

2,093

31 %

The decrease in G&A compensation expenses of $0.3 million and $0.5 million for the three and six months ended June 30, 2026, respectively, compared to the three and six months ended June 30, 2025, was due primarily to a decrease in headcount in the current year periods compared to the same periods in the prior year.
The increase in G&A professional fees and other of $0.6 million and $2.6 million for the three and six months ended June 30, 2026, respectively, compared to the three and six months ended June 30, 2025, was due primarily to higher legal fees of $0.7 million and $2.5 million, for the three and six months ended June 30, 2026, respectively, related to our patent litigation matters, which have now been settled, as well as fees associated with management of our intellectual property portfolio and legal costs related to our SEC compliance and other stock administration matters incurred during the current year periods.
Interest Income. Interest income was $0.2 million and $0.5 million for the three and six months ended June 30, 2026, respectively, and decreased $0.4 million and $0.8 million compared to the three and six months ended June 30, 2025, respectively. The decrease was due primarily to lower average cash balances invested in our money market account during the current year periods relative to the same periods in the prior year.

(Press release, Atossa Therapeutics, AUG 7, 2026, View Source [SID1234669882])

On August 7, 2026 bioAffinity Technologies, Inc. (Nasdaq: BIAF; BIAFW), a biotechnology company focused on the need for noninvasive, accurate tests for the detection of early-stage lung cancer and other lung diseases and topically delivered therapeutics for squamous and basal cell skin cancers, reported financial results and business highlights for the quarter ended June 30, 2026.

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Q2 2026 Highlights and Recent Events

● CyPath Lung diagnostic test volume increased 216% during the second quarter of 2026 compared to the second quarter of 2025.

● CyPath Lung testing revenue for the first six months of 2026 increased 159% to approximately $835,000, compared with approximately $323,000 for the first six months of 2025.

● The Company delivered 1,097 CyPath Lung test reports during the first six months of 2026, compared with 390 during the same period of 2025.

● The number of physician offices and clinics ordering CyPath Lung for their patients increased 122% during the second quarter of 2026 compared to the same period in 2025.

● Existing clients as of June 30, 2025, increased their CyPath Lung orders by 71% year over year during the first six months of 2026.

● The longitudinal clinical trial designed to evaluate the clinical performance of the CyPath Lung test has begun patient enrollment at 11 clinical sites, including nine Department of Veterans Affairs (VA) and military medical centers. Financial support for the trial has been provided by the John P. Murtha Cancer Center Research Program (MCCRP), a research program within the Department of Surgery at the Uniformed Services University of the Health Sciences in Bethesda, Maryland.

● Positive preliminary therapeutic data support the development of topical treatments for squamous and basal cell skin cancers, with self-delivering stabilized siRNAs selectively killing melanoma, squamous and basal carcinoma cells while sparing healthy cutaneous cells.

● bioAffinity presented positive research results advancing its diagnostic platform designed to identify antibody drug receptors in sputum to match patients with the most appropriate biologic therapies, including receptors for dupilumab, a leading therapy for asthma and chronic obstructive pulmonary disease (COPD), and benralizumab, another asthma therapy.

● The Company published a comprehensive clinical review and white paper authored by Chief Medical Officer Gordon H. Downie, MD, PhD, that presents a practical clinical framework for incorporating CyPath Lung into pulmonary nodule evaluation and cancer surveillance.

● The Company announced a collaboration with Pictor, Inc., a targeted proteomic platform company, to support development and commercialization of bioAffinity Technologies’ next-generation diagnostic tests designed to provide a more complete picture of lung inflammation in patients with asthma and COPD.

● The Society for Advanced Bronchoscopy (SAB) and National Association of Veterans Research Education Foundations (NAVREF) hosted webinars featuring multi-disciplinary panels of physicians who discussed CyPath Lung’s expanding role in the lung nodule care continuum.

● bioAffinity received notification of allowance from the Mexican Institute of Industrial Property for a patent application protecting the use of defined antibodies and the porphyrin TCPP to label cell populations in sputum and the use of flow cytometry to determine the presence of lung cancer cells in sputum.

● In June 2026, bioAffinity completed a public offering that generated approximately $3.2 million in gross proceeds to support commercialization activities, clinical development, and general corporate purposes.

Management Commentary

"Our commercial strategy continues to gain significant traction as physicians increasingly recognize the clinical value of CyPath Lung for evaluating patients at high risk for lung cancer and surveilling lung cancer survivors for recurrence," said Maria Zannes, President and Chief Executive Officer of bioAffinity Technologies. "During the second quarter, CyPath Lung test volume surged 216% year-over-year. This growth reflects accelerating physician adoption and clinical confidence in our technology. As more clinics integrate CyPath Lung into their standard of care workflows, peer-to-peer education is a powerful driving force behind building broader awareness of the test’s ability to provide objective data that complements traditional imaging and supports faster, more informed clinical decisions."

Ms. Zannes continued, "Alongside our commercial momentum, we achieved critical milestones across our strategic roadmap. In the second quarter, we expanded physician education initiatives, including scientific presentations, webinars, podcasts and real-world clinical case studies. We continued to make progress in our large-scale longitudinal study that includes VA and military medical centers, expanding our outreach to veterans. By leveraging our expertise in flow cytometry and AI and our work with siRNAs, we are building a robust pipeline of precision diagnostics for the large asthma and COPD markets and even larger therapeutic markets for topically delivered drugs that treat squamous and basal cell skin cancers."

Ms. Zannes concluded, "Looking ahead, our priorities for the second half of 2026 are expanding physician adoption, increasing utilization among existing customers, and introducing CyPath Lung to new healthcare systems and specialty practices, including oncology. The positive results we see from research and development of precision diagnostics and a therapeutic for skin cancers are exciting as we advance our pipeline. We believe this balanced approach positions bioAffinity to create lasting value for patients, healthcare providers and shareholders."

Second Quarter 2026 Financial Results

Revenue for the quarter ended June 30, 2026, was $1.5 million, a 19% increase from the $1.3 million reported for the same period in 2025. The increase is primarily due to an increase in sales of CyPath Lung.

Operating expenses for the second quarter of 2026 were $4.8 million, compared with $3.8 million in the second quarter of 2025.

● Direct costs and expenses for the second quarter of 2026 were $1.1 million, compared to $1 million in the prior-year period, primarily reflecting higher CyPath Lung test volume.

● Research and development expenses increased 16% year-over-year to $362,000, driven by laboratory supply purchases and costs associated with relocating the research and development lab from the University of Texas at San Antonio to the Precision Pathology Laboratory services campus.

● Clinical development expenses rose to $476,000 from $129,000 in the second quarter of 2025 due to costs associated with initiating the longitudinal clinical study.

● Selling, general and administrative expenses were $2.9 million for the second quarter of 2026, up from $2.2 million in the same period last year. The increase was primarily driven by higher employee compensation, reflecting the addition of sales and administrative personnel to support the expanding commercialization of CyPath Lung.

Net loss for the quarter ended June 30, 2026, was $3.4 million, compared with a net loss of $4.1 million for the second quarter of 2025.

Cash and cash equivalents as of June 30, 2026, were $2.4 million, compared with $6.4 million as of December 31, 2025.

About CyPath Lung

CyPath Lung by bioAffinity Technologies is a noninvasive test designed to improve the early detection of lung cancer in patients at high risk for the disease. CyPath Lung uses advanced flow cytometry and proprietary artificial intelligence (AI) to identify cell populations in patient sputum that indicate malignancy. CyPath Lung incorporates a fluorescent porphyrin that is preferentially taken up by cancer and cancer-related cells. In a published clinical trial of high-risk patients, CyPath Lung demonstrated 92% sensitivity, 87% specificity, 88% accuracy and 99% negative predictive value (NPV) in detecting lung cancer in patients at high risk for the disease who had small indeterminate lung nodules less than 20 millimeters. The high NPV gives physicians greater confidence that a negative result is truly negative, potentially sparing patients from unnecessary invasive and costly procedures. CyPath Lung is marketed as a Laboratory Developed Test (LDT) and is not intended for use as a sole diagnostic tool and should be considered alongside other clinical findings.

(Press release, BioAffinity Technologies, AUG 7, 2026, View Source [SID1234669870])