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.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

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])

On August 6, 2026 Merck KGaA reported second quarter financial results.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

(Presentation, Merck KGaA, AUG 6, 2026, View Source [SID1234670613])

On August 6, 2026 Merck KGaA reported second quarter financial results.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

(Press release, Merck KGaA, AUG 6, 2026, View Source [SID1234670612])

On August 6, 2026 Intellia Therapeutics, Inc. (Nasdaq: NTLA), a leading biopharmaceutical company focused on revolutionizing medicine leveraging CRISPR gene editing and other core technologies, reported business updates and financial results for the second quarter ended June 30, 2026.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"The second quarter was a momentous period for Intellia highlighted by the positive Phase 3 HAELO clinical trial results we reported for lonvo-z in hereditary angioedema," said John Leonard, M.D., Intellia President and Chief Executive Officer. "These data serve as strong validation for in vivo gene editing and lonvo-z’s potential to transform the treatment paradigm for patients who are burdened by this disease."

"We also resumed enrollment in our Phase 3 clinical trials in ATTR during the second quarter and gained important new genomic insights that enhance our understanding of nex-z’s safety profile and its potential to deliver clinically meaningful outcomes for patients. Underpinned by a recent capital raise that strengthened our balance sheet, we are well positioned to deliver on our research, regulatory, clinical and commercial objectives," Dr. Leonard concluded.

Lonvoguran Ziclumeran (Lonvo-z) for Hereditary Angioedema (HAE)

Designed as a one-time treatment that is administered in an outpatient setting, lonvo-z is an in vivo CRISPR gene editing candidate that is intended to inactivate the kallikrein B1 (KLKB1) gene to permanently lower kallikrein and bradykinin levels and to eliminate HAE attacks.

•
In April, Intellia announced positive topline results from the global Phase 3 HAELO clinical trial of lonvo-z in HAE. In June, additional data were reported in a late-breaking oral session at the European Academy of Allergy & Clinical Immunology Annual Congress 2026 and in a manuscript published in the New England Journal of Medicine. Highlights included:
–
The trial met its primary endpoint. For the six-month efficacy evaluation period (weeks 5 to 28), a one-time infusion of lonvo-z reduced attacks by 87% versus placebo, with a mean monthly attack rate of 0.26 in the lonvo-z arm compared with 2.10 in the placebo arm (p<0.0001).
–
The trial met all of its key secondary endpoints with statistical significance (p<0.0001). These included:
▪
62% of patients were entirely attack free and therapy free in the lonvo-z arm for the six-month efficacy evaluation period, compared with 11% of patients in the placebo arm;
▪
The mean monthly rate of attacks requiring on-demand treatment was 0.19 in the lonvo-z arm for the six-month efficacy evaluation period, compared with 1.79 in the placebo arm;
▪
The mean monthly rate of moderate/severe attacks was 0.11 in the lonvo-z arm for the six-month efficacy evaluation period, compared with 1.23 in the placebo arm; and
▪
The change in Angioedema Quality of Life (AE-QoL) total score was -23.51 in the lonvo-z arm from baseline to week 28, compared with -6.47 in the placebo arm.
–
All patients in the lonvo-z arm experienced attack-rate reductions from baseline compared with weeks 5 to 28.
–
Attack-rate reductions were observed for all evaluated subgroups.
–
All patients who received lonvo-z at baseline or in crossover after week 28 remained free from long-term prophylaxis therapy as of the February 10, 2026 data cutoff.
–
Favorable safety and tolerability data were observed for lonvo-z. The most common treatment emergent adverse events (TEAEs) were infusion-related reactions, headache, fatigue, back pain, and upper respiratory tract infection. All TEAEs reported were mild or moderate (Grade 1 or Grade 2), and there were no serious adverse events observed in the lonvo-z arm.
•
During the second quarter, the company launched www.HAEreframed.com. The campaign aims to raise awareness of the significant burden of HAE and patients’ top concerns, including the mental toll of the disease and the challenges of taking and maintaining access to chronic treatment.
•
Intellia significantly advanced its launch readiness activities in recent months, including finalizing its field medical, reimbursement and strategic accounts teams and engaging with HAE treatment centers around the U.S.
•
Intellia expects the U.S. Food and Drug Administration (FDA) to accept its submission of a biologics license application (BLA) for lonvo-z in the second half of 2026. If approved, Intellia plans to launch lonvo-z commercially in the first half of 2027.

Nexiguran Ziclumeran (Nex-z) for Transthyretin (ATTR) Amyloidosis

Nex-z is an investigational in vivo CRISPR-based therapeutic candidate designed to inactivate the TTR gene in the liver, thereby preventing the production of transthyretin (TTR) protein. Nex-z offers the possibility of halting and reversing disease by driving a rapid, deep, consistent and potentially lifelong reduction in TTR protein after a one-time treatment. Intellia leads the development and commercialization of nex-z in collaboration with Regeneron Pharmaceuticals, Inc. (Regeneron).

Together with Regeneron and other external experts, Intellia recently conducted a comprehensive genomic analysis of more than 600 patient samples across nex-z clinical trials. The analysis revealed that the highest observed liver transaminase elevations were in patients carrying one specific human leukocyte antigen (HLA) allele. As Intellia engages with the FDA and global health authorities regarding this finding, the company will provide HLA genotyping results to investigators and patients enrolled or entering screening in the ongoing nex-z Phase 3 trials.

•
During the second quarter, nex-z Phase 1 clinical data in ATTR were presented at the Peripheral Nerve Society Annual Meeting in Maastricht, the Netherlands and at the European Society of Cardiology Heart Failure Congress in Barcelona, Spain.
•
Intellia has advanced enrollment in its MAGNITUDE and MAGNITUDE-2 Phase 3 clinical trials of nex-z in ATTR amyloidosis with cardiomyopathy (ATTR-CM) and hereditary ATTR amyloidosis with polyneuropathy (ATTRv-PN), respectively.
•
Intellia remains on track to complete patient enrollment in MAGNITUDE-2 in the second half of 2026.

Upcoming Events

The company will participate in the following events during the third quarter of 2026:

•
Bradykinin Symposium 2026, September 2-3, Berlin, Germany
•
Wells Fargo 21st Annual Healthcare Conference, September 9, Boston
•
Morgan Stanley 24th Annual Global Healthcare Conference, September 14, New York

Second Quarter 2026 Financial Results

•
Cash Position: In April 2026, the company completed an underwritten public offering of its common stock resulting in approximately $195 million in net proceeds. Cash, cash equivalents and marketable securities were $628.4 million as of June 30, 2026, compared to $605.1 million as of December 31, 2025. The company’s existing cash resources are expected to fund its operations at least into 2028 and well beyond lonvo-z’s anticipated U.S. commercial launch for HAE in the first half of 2027. This guidance excludes all potential commercial revenues from lonvo-z.
•
Collaboration Revenue: Collaboration revenue was $7.7 million for the second quarter of 2026, compared to $14.2 million for the second quarter of 2025. The decrease is primarily due to a reduction in revenue from Regeneron.
•
R&D Expenses: Research and development (R&D) expenses were $82.6 million for the second quarter of 2026, compared to $97.0 million for the second quarter of 2025. The decrease was primarily driven by lower external costs related to the company’s lead development programs and reduced stock-based compensation, partially offset by higher employee-related expenses due to increased headcount. Stock-based compensation expense included in R&D expenses was $9.4 million for the second quarter of 2026.
•
G&A Expenses: General and administrative (G&A) expenses were $37.8 million for the second quarter of 2026, compared to $27.2 million for the second quarter of 2025. The increase was primarily driven by costs associated with the ongoing buildout of the company’s commercial infrastructure, higher legal expenses and stock-based compensation. Stock-based compensation expense included in G&A expenses was $8.6 million for the second quarter of 2026.
•
Net Loss: Net loss was $106.6 million for the second quarter of 2026, compared to $101.3 million for the second quarter of 2025.

(Press release, Intellia, AUG 6, 2026, View Source [SID1234669872])

On August 6, 2026 Alector, Inc. (Nasdaq: ALEC), a biotechnology company focused on developing therapies to counteract the devastating progression of neurodegeneration, reported second quarter 2026 financial results and recent portfolio and business updates. As of June 30, 2026, Alector’s cash, cash equivalents, and investments totaled $172.8 million.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"We continue to make steady progress across our ABC-enabled preclinical and research pipeline," said Arnon Rosenthal, Ph.D., Chief Executive Officer of Alector. "Our work across antibodies, enzymes, and siRNA reflects the versatility of the ABC platform and our strategy to apply it to programs where enhanced brain delivery may address important limitations in the treatment of neurodegenerative diseases. We remain focused on disciplined execution as we advance our portfolio toward clinical development, with the goal of addressing important unmet needs for patients living with neurodegenerative diseases."

Recent Program Updates

Alector Brain Carrier (ABC): Preclinical and Research Pipeline

Alector’s proprietary Alector Brain Carrier (ABC) blood-brain barrier platform is central to the company’s strategy to enhance therapeutic delivery to the brain. ABC is designed to achieve efficient, enhanced brain delivery through differentiated binding to a distinct region of the transferrin receptor (TfR) and to enable peripheral dosing, while preserving a favorable safety profile. It is adaptable across multiple drug modalities, including antibodies, enzymes, and siRNA.

Core to the platform’s design are the principles of versatility, translatability, and differentiated binding. Preclinical studies across multiple ABC-enabled programs have shown robust brain penetration, supporting the advancement of a broad pipeline directed at the underlying drivers of neurodegenerative diseases.

AL137

•
Following successful completion of IND-enabling studies evaluating both subcutaneous (SC) and intravenous (IV) administration, Alector selected AL137 as the lead molecule for its anti-amyloid beta (Aβ) antibody program for AD, with AL037 retained as a backup candidate. The company is targeting an IND submission in Q1 2027 and first-in-human dosing in Australia no later than April 2027.
•
AL137 combines Alector’s proprietary high-affinity fully human anti-Aβ antibody which selectively binds pyroglutamate-3 (PyroGlu3-Aβ), a validated and pathogenic form of Aβ enriched in amyloid plaques, with the company’s proprietary ABC platform. Based on preclinical studies, AL137 is designed to be delivered SC and to combine several differentiated attributes intended to optimize efficacy, safety, convenience, and manufacturability, including:
•
High brain exposure and efficient brain delivery through the ABC platform, supporting low projected efficacious dose.
•
Preserved full IgG1 Fc effector function, designed to maximize recruitment of brain immune cells for efficient amyloid plaque clearance.
•
A proprietary transferrin receptor (TfR)-binding epitope designed to maintain brain delivery while reducing hematologic adverse effects associated with targeting TfR with a full Fc effector function.
•
A favorable preclinical safety profile to support the planned clinical study, with no observed adverse effects and only transient, reversible, non-adverse hematological findings with SC dosing.
•
Supportive pharmacokinetic and formulation characteristics intended to enable convenient monthly subcutaneous administration using a high-concentration formulation.
•
High-productivity manufacturability, with an identified stable, high-expressing cell line designed to support efficient large-scale manufacturing and commercial scalability.

ABC-Enabled siRNA Platform

•
Alector continues to advance its ABC-enabled siRNA platform, designed for peripheral dosing and offering the potential for more convenient administration compared with traditional intrathecal delivery, as well as the potential for homogeneous drug distribution throughout the brain.

AL064/AL164

•
Alector’s lead siRNA program, AL064/AL164, is a tau siRNA program for AD and other tauopathies and aims to reduce toxic tau protein expression and slowing of cognitive decline in AD.
•
AL064 demonstrated robust tau mRNA knockdown and durable reduction of phospho-Tau 217 in non-human primate brains. AL064 was modified to incorporate a well-validated chemical modification intended to further optimize siRNA stability, and this modified form is advancing into IND-enabling studies as AL164.

Early-Stage siRNA Programs

•
Earlier-stage siRNA programs advancing toward lead candidate selection include ADP062-ABC, an alpha-synuclein siRNA for PD, and ADP065-ABC, an NLRP3 siRNA for multiple neurodegenerative conditions, reflecting the broad applicability of the ABC platform across disease mechanisms. Alector continues to evaluate development plans and timing for its ABC-enabled siRNA programs.

AL050

•
AL050, Alector’s ABC-enabled engineered glucocerebrosidase (GCase) enzyme replacement therapy (ERT), is in preclinical development for PD.
•
AL050 is engineered to overcome the central challenges of delivering enzyme therapy to the brain, combining an engineered GCase with enhanced activity and stability, a silenced effector function for safety, and Alector’s tunable ABC technology. To date, preclinical data have demonstrated increased GCase activity in both rodents and NHPs and reduced toxic substrate accumulation in a rodent GBA disease model with no apparent hematologic findings, supporting continued development as a potential therapy for PD and Lewy body dementia (LBD) associated with GBA loss-of-function mutations and subsequently for idiopathic PD and LBD.

Second Quarter 2026 Financial Results

Revenue. Collaboration revenue for the quarter ended June 30, 2026, was $3.3 million, compared to $7.9 million for the same period in 2025. The decrease was primarily due to lower revenue recognized for the AL101 AD program.

R&D Expenses. Total research and development expenses for the quarter ended June 30, 2026, were $19.5 million, compared to $27.6 million for the quarter ended June 30, 2025.

The decrease was mainly due to a decrease in personnel-related costs as a result of the reductions in force as well as a decrease in facilities and other expenses.

G&A Expenses. Total general and administrative expenses for the quarter ended June 30, 2026, were $8.3 million, compared to $14.4 million for the quarter ended June 30, 2025. The decrease was mainly driven by a decrease in personnel-related costs as a result of the reductions in force.

Net Loss. For the quarter ended June 30, 2026, Alector reported a net loss of $23.0 million, or $0.21 net loss per share, compared to a net loss of $30.5 million, or $0.30 net loss per share, for the same period in 2025.

Cash Position. Cash, cash equivalents, and investments were $172.8 million as of June 30, 2026. Management anticipates that this will be sufficient to fund Alector’s operations at least through 2027.

(Press release, Alector, AUG 6, 2026, View Source [SID1234669869])