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.

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"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.

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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:
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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).
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The trial met all of its key secondary endpoints with statistical significance (p<0.0001). These included:
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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;
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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;
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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
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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.
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All patients in the lonvo-z arm experienced attack-rate reductions from baseline compared with weeks 5 to 28.
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Attack-rate reductions were observed for all evaluated subgroups.
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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.
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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.
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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.
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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.
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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.

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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.
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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.
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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:

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

Second Quarter 2026 Financial Results

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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.
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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.
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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.
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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.
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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.

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"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

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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.
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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:
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High brain exposure and efficient brain delivery through the ABC platform, supporting low projected efficacious dose.
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Preserved full IgG1 Fc effector function, designed to maximize recruitment of brain immune cells for efficient amyloid plaque clearance.
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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.
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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.
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Supportive pharmacokinetic and formulation characteristics intended to enable convenient monthly subcutaneous administration using a high-concentration formulation.
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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

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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

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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.
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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

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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

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AL050, Alector’s ABC-enabled engineered glucocerebrosidase (GCase) enzyme replacement therapy (ERT), is in preclinical development for PD.
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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])

On August 6, 2026 Theriva Biologics (NYSE American: TOVX), a diversified clinical-stage company developing therapeutics designed to treat cancer and related diseases in areas of high unmet need, reported the dosing of the first patient in the VIRAGE2 Phase 2a clinical trial, a small proof-of-concept study evaluating more frequent repeated dosing of VCN-01 (zabilugene almadenorepvec) in first-line metastatic PDAC patients treated with standard-of-care gemcitabine/nab-paclitaxel chemotherapy (SoC; see About VIRAGE2 below). Enrollment into the VIRAGE2 trial is expected to be completed in H2 2026 and initial pharmacodynamic and safety/tolerability data are anticipated by Q3 2027. Results from this trial will inform the VCN-01 dosing regimen for potential evaluation in a future pivotal Phase 3 clinical trial.

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The VIRAGE2 clinical trial is based on observations from the VIRAGE Phase 2b clinical trial in metastatic PDAC patients where patients administered 2 doses of VCN-01 in combination with gemcitabine/nab-paclitaxel SoC chemotherapy exhibited improved overall survival, progression-free survival, and duration of response compared to patients treated with SoC chemotherapy alone. As previously reported, both EMA scientific advice and FDA meeting feedback recognized the improved survival in the group treated with 2 doses of VCN-01, and raised the possibility of more frequent, repeated dosing of VCN-01 in combination with SoC chemotherapy to potentially improve clinical outcomes.

"The first patient dosed in VIRAGE2 marks an important clinical development milestone as the evaluation of more frequent, repeated dosing is a critical step in the advancement of VCN-01 towards a potential pivotal Phase 3 clinical trial in metastatic PDAC patients," said Steven A. Shallcross, Chief Executive Officer of Theriva Biologics. "Our current clinical data indicate that repeated administration of VCN-01 to metastatic PDAC patients may significantly increase its tumor stroma-degrading effects and further enhance the antitumor immune response. A positive outcome from the VIRAGE2 trial will enable us to refine the design and dosing regimen of our proposed pivotal Phase 3 clinical trial in metastatic PDAC patients treated with SoC chemotherapy. Since the tumor stroma is a challenge for multiple classes of cancer therapies, a repeated VCN-01 dosing regimen may also improve outcomes when combined with other interventions such as immunotherapies, antibody-drug conjugates, KRAS inhibitors, and emerging targeted cancer treatments."

About Pancreatic Ductal Adenocarcinoma

Cancer of the pancreas consists of two main histological types: cancer that arises from the ductal (exocrine) cells of the pancreas or, much less often, cancers may arise from the endocrine compartment of the pancreas. Pancreatic ductal adenocarcinoma ("PDAC") accounts for more than 90% of all pancreatic tumors. It can be located either in the head of the pancreas or in the body/tail. Pancreatic cancer usually metastasizes to the liver and peritoneum. Other less common metastatic sites are the lungs, brain, kidney, and bone. In its early stages, pancreatic cancer does not typically result in any characteristic symptoms. In many instances, progressive abdominal pain is the first symptom. Therefore, in most cases, pancreatic cancer is diagnosed in its late stages (locally advanced non-metastatic or metastatic stage of the disease) when surgical resection and possibly curative treatment is not possible. It is generally assumed that only 10% of cases are resectable at presentation, whereas 30-40% of patients are diagnosed at local advanced/unresectable stage and 50-60% present with distant metastases.

About VIRAGE2

VIRAGE2 is a Phase 2a, single-arm, open-label, clinical trial in 6 evaluable patients with histologically confirmed, newly diagnosed metastatic PDAC enrolled at a single site in Spain. Patients are intended to receive at least three "macrocycles" of VCN-01 (zabilugene almadenorepvec) and gemcitabine/nab-paclitaxel standard-of-care (SoC) chemotherapy, followed by SoC gemcitabine/nab-paclitaxel cycles until disease progression. In each VCN-01 macrocycle, intravenous VCN-01 is administered on day 1 followed by gemcitabine/nab-paclitaxel SoC chemotherapy on days 8, 15, 22, 36, 43, and 50. Macrocycles are repeated on days 57 and 113. The primary objective of the VIRAGE2 trial is to evaluate whether administration of at least 3 doses of VCN-01, with approximately 2 months between doses, is well tolerated by patients without adversely impacting VCN-01 pharmacodynamics. Primary endpoints for the trial are the adverse event profile and levels of VCN-01 viral genomes in blood. Secondary endpoints include objective response rate, duration of response, progression free survival, overall survival, and circulating levels of anti-VCN-01 neutralizing antibodies. Exploratory endpoints include estimates of potential VCN-01 shedding by measuring VCN-01 viral genomes in sputum and stool. The study is designed with 80% power to detect a difference in VCN-01 viral genome levels between the second and first VCN-01 doses with a 2-sided alpha of 0.05. The study is not formally powered for evaluation of clinical efficacy endpoints and is intended to support evaluation of the potential efficacy of the more frequent repeated dosing regimen in subsequent clinical trials (EUCT: 2026-525566-21-00; NCT07701486).

About VCN-01

VCN-01 (zabilugene almadenorepvec) is a systemically administered oncolytic adenovirus designed to selectively and aggressively replicate within tumor cells and degrade the tumor stroma that serves as a significant physical and immunosuppressive barrier to cancer treatment. This unique mode-of-action enables VCN-01 to exert multiple antitumor effects by (i) selectively infecting and lysing tumor cells; (ii) enhancing the access and perfusion of co-administered chemotherapy products; and (iii) increasing tumor immunogenicity and exposing the tumor to the patient’s immune system and co-administered immunotherapy products. Systemic administration enables VCN-01 to exert its actions on both the primary tumor and metastases. With the first patient dosed in VIRAGE2, VCN-01 has been administered to 143 patients in Company- and investigator-sponsored clinical trials in different cancers, including PDAC (in combination with chemotherapy), head and neck squamous cell carcinoma (with an immune checkpoint inhibitor), ovarian cancer (with CAR-T cell therapy), colorectal cancer, and retinoblastoma (by intravitreal injection). VCN-01 has also been made available for compassionate use in retinoblastoma patients, and 2 patients have been treated in this program. More information on VCN-01 clinical trials is available at Clinicaltrials.gov.

(Press release, Theriva Biologics, AUG 6, 2026, View Source [SID1234669849])

On August 6, 2026 CancerVax, Inc., the developer of a breakthrough universal cancer treatment platform that "tricks" the body’s immune system into fighting cancer, reported that it has successfully activated human antiviral memory CD8+ T-cells. Before T-cells can kill cancer cells, they must be first activated. The latest studies validated this important part of the platform.

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The CancerVax platform is designed to harness the body’s existing immunity to detect, mark, and kill cancer cells with precision. At the core of the platform is a Smart mRNA that selectively activates in cancer cells. When activated, this Smart mRNA instructs cancer cells to produce proteins associated with viruses that are highly prevalent in the human population. This effectively disguises cancer cells as familiar viral infections and "tricks" the immune system into recognizing and killing them.

On July 14, 2026, the Company announced that it developed a novel Polyepitope Smart mRNA that can disguise cancer as multiple viral infections. This takes a shot gun approach to immune activation and was confirmed through computational analysis that it can activate pre-existing viral immunity in 99% of the world population. This Polyepitope Smart mRNA was encapsulated into the Company’s novel cell-targeting lipid nanoparticles ("LNP") and tested against a known liver cancer cell line along with human Peripheral Blood Mononuclear Cells ("PBMC").

PBMCs are white blood cells primarily comprising lymphocytes (T-cells, B-cells, and Natural Killer cells) and monocytes. A specific type of T-cells, memory CD8+ Killer T-cells, are created by the body after vaccination or natural infection to protect against reinfection. These T-cells circulate in the body from months to years after vaccination or infection. In the case of measles, memory T-cells are expected to persist for decades or even for life. The Polyepitope Smart mRNA was specifically designed to activate Killer CD8+ T-cells against common diseases such as measles, influenza, and more.

The study used an ELISpot assay, which counts individual T-cells releasing interferon-gamma, the signal a Killer T-cell sends when it recognizes its target. Human PBMCs were introduced in vitro to liver cancer cells treated with the full CancerVax therapeutic nanoparticles. The data below shows that CD8+ Killer T-cells were strongly activated in a statistically significant manner.

Dr. Adam Grant, Principal Scientist of CancerVax, commented, "This is a watershed moment for CancerVax and our novel approach to cancer immunotherapy. I’ll never forget seeing this data for the first time. These are human immune cells from real donors, not a mouse model, and they woke up to signals emanating from liver cancer cells that had been disguised to look like common diseases and are ready to attack. We took the experiment through multiple steps to make sure the results were what we hypothesized. We stripped out the CD4 T-cells and the response held. We stripped out the CD8+ T-cells and it didn’t show activation. That tells us exactly which cells were doing the work. Our next experiments are designed to test how effectively these activated memory CD8+ T-cells kill cancer cells."

"This study is an important validation of our platform’s mechanism," said Dr. George Katibah, Chief Scientific Officer of CancerVax. "By showing that our Polyepitope Smart mRNA can cause cancer cells to display familiar viral targets and activate pre-existing human antiviral CD8+ T-cells, we have demonstrated a key biological step in our strategy to redirect immune memory against cancer. Without knowing which specific immunity that the donor PBMCs have, our Polyepitope Smart mRNA made the cancer cells look like many diseases. All we need is one or more matches. These in-vitro findings confirmed that we had a strong epitope hit and support advancing the program into tumor-killing and additional preclinical studies."

(Press release, CancerVax, AUG 6, 2026, View Source [SID1234669848])

On August 6, 2026 Foghorn Therapeutics Inc. (Nasdaq: FHTX), a clinical-stage biotechnology company pioneering a new class of medicines that treat serious diseases by correcting abnormal gene expression, reported a financial and corporate update in conjunction with the Company’s 10-Q filing for the second quarter ended June 30, 2026. With an initial focus in oncology, Foghorn’s Gene Traffic Control Platform and resulting broad pipeline have the potential to transform the lives of people suffering from a wide spectrum of diseases.

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"Our FHD-909 trial in collaboration with Lilly continues to advance through dose escalation, with an initial focus on SMARCA4-mutant NSCLC, a setting where effective treatment options remain limited and outcomes poor," said Adrian Gottschalk, President and Chief Executive Officer of Foghorn Therapeutics.

Mr. Gottschalk continued, "We are excited to advance our wholly-owned pipeline toward the clinic. Beyond oncology, we are now extending the reach of our platform with an undisclosed program in immunology and inflammation. We are targeting an IND in 2027 for this asset, underscoring the breadth of our platform and demonstrating its potential across multiple therapeutic areas. In oncology, our Selective EP300 degrader program in multiple myeloma has shown improved safety and efficacy versus clinical benchmarks, while our Selective CBP degrader, FHT-171, has demonstrated strong anti-tumor activity and tolerability in heavily pretreated ER+ breast cancer models. Together, these programs reflect the significant opportunity we see to expand our pipeline and create value across multiple therapeutic areas."

Program Overview and Upcoming Milestones

FHD-909 (LY4050784). FHD-909 is a first-in-class oral SMARCA2 selective inhibitor that has demonstrated in preclinical studies to have high selectivity over its closely-related paralog SMARCA4, two proteins that are the catalytic engines across all forms of the BAF complex. Selectively blocking SMARCA2 activity is a promising synthetic lethal strategy intended to induce tumor death while sparing healthy cells. SMARCA4 is mutated in up to 10% of NSCLC and implicated in a significant number of solid tumors. Across lines of therapy, significant unmet needs remain for patients with SMARCA4 (BRG1)-mutant cancers with both poor response rates and short progression-free survival.

Phase 1 trial on track. Enrollment in the first-in-human Phase 1 multi-center trial of FHD-909 is progressing well. The trial in patients with NSCLC as the primary target population is on track, following the dosing of the first patient in October 2024.

Robust and durable preclinical data for FHD-909 plus anti-PD-1 antibody. Preclinical data have demonstrated complete tumor regression in syngeneic efficacy models of FHD-909 in combination with an anti-PD-1 antibody, with no tumor regrowth observed after dosing was halted. An immune memory effect was further supported by tumor rejection upon rechallenge in treated animals.
Pending successful Phase 1 dose escalation results, Foghorn and Lilly anticipate evaluating FHD-909 in combination studies in NSCLC with pembrolizumab.

Ongoing strategic collaboration with Lilly. Foghorn is collaborating with Lilly to develop novel oncology medicines, including a 50/50 U.S. co-development and co-commercialization agreement for its selective SMARCA2 oncology program that includes both a selective inhibitor and a selective degrader, as well as an additional undisclosed oncology target. The collaboration, the research term of which will expire in December 2026, also includes three discovery programs from Foghorn’s proprietary Gene Traffic Control platform.

I&I Novel Oral Small Molecule. Foghorn is advancing a novel oral small molecule in immunology and inflammation (I&I).

IND targeted in 2027.

Selective EP300 degrader program. These degraders are being developed for the treatment of hematological malignancies and prostate cancer. Attempts to selectively drug EP300 have been challenging due to the high level of similarity between EP300 and CBP, while dual inhibition of CBP/EP300 has been associated with dose limiting toxicities. EP300 lineage dependencies are established in multiple myeloma (MM) and diffuse large b-cell lymphoma (DLBCL).

EP300 degrader program outperforms clinical benchmark. Preclinical data highlight the therapeutic potential in multiple myeloma, including superior anti-tumor activity with complete responses, compared to clinical benchmark dual CBP/EP300 inhibitor inobrodib, superior safety by body weight loss and platelet counts over dual degradation, and tumor regression in a multiple myeloma xenograft model of acquired pomalidomide resistance.
IND targeted in 2027, with a focus in MM and DLBCL.

Selective CBP degrader program. These degraders selectively target CBP, an acetyltransferase closely related to EP300. CBP lineage dependencies are established in several cancers, including breast cancer, and there is also a synthetic relationship in EP300-mutated cancers, which include endometrial, cervical, ovarian, bladder, and colorectal cancer. Attempts to selectively drug CBP have been challenging due to the high level of similarity between the two proteins, while dual inhibition of CBP/EP300 has been associated with dose-limiting toxicities.

CBPd-171 shows strong therapeutic potential in ER+ breast cancer. Preclinical data for our lead Selective CBP degrader, CBPd-171, highlighted strong anti-tumor activity as a monotherapy in PDX models of heavily pretreated ER+ breast cancer, favorable preclinical in vivo tolerability profile, and high selectivity and potent CBP degradation with clear on-target transcriptional effects. We have developed a long-acting injectable (LAI) formulation for weekly subcutaneous administration to support convenient and patient-friendly dosing.
The CBPd-171 timeline has been delayed due to an unexpected operational issue at a third-party contract research organization supporting the in vivo animal models. The Company will provide updated guidance once available.

Selective ARID1B degrader program. These degraders selectively target and degrade ARID1B and are being positioned as synthetic lethal opportunities for ARID1A-mutated cancers. ARID1A is the most mutated subunit in the BAF complex and amongst the most mutated proteins in cancer. These mutations lead to a dependency on ARID1B in several types of cancer, including endometrial, gastric, bladder and NSCLC. Attempts to selectively drug ARID1B have been challenging because of the high degree of similarity between ARID1A and ARID1B and the fact that ARID1B has no enzymatic activity to target. ARID1B is a major synthetic lethal target implicated in up to 5% of all solid tumors.

First-in-class Selective ARID1B degrader program. Robust degradation with potential for oral bioavailability demonstrated preclinically across our cereblon-based Selective ARID1B degraders. Foghorn is developing cereblon-based bifunctional degraders achieving selective degradation of ARID1B and modulation of downstream target genes consistent with ARID1B pathway disruption.

Platform. Foghorn continues to advance its chromatin biology and degrader platform with investments in molecular glues, RIPTACs and induced proximity.

Second Quarter 2026 Financial Highlights

Collaboration Revenue. Collaboration revenue was $16.1 million for the three months ended June 30, 2026, compared to $7.6 million for the three months ended June 30, 2025. The $8.5 million increase was driven by a $14.2 million cumulative catch-up adjustment to reflect updated future costs primarily due to the scheduled expiration of the research term in December 2026 partially offset by the timing of work performed under the Lilly Collaboration Agreement.

Research and Development Expenses. Research and development expenses were $18.5 million for the three months ended June 30, 2026, compared to $21.8 million for the three months ended June 30, 2025. The $3.3 million decrease is attributed to a decrease in Lilly-partnered program costs, decreases in facilities and IT-related expenses, a decrease in FHD-286 costs, and decreases in personnel-related costs partially offset by an increase in early development and other external costs.

General and Administrative Expenses. General and administrative expenses were $6.4 million for the three months ended June 30, 2026, compared to $6.9 million for the three months ended June 30, 2025. This $0.5 million decrease was primarily due to lower facilities and IT-related expenses.

Net Loss. Net loss was $7.2 million for the three months ended June 30, 2026, compared to a net loss of $17.9 million for the three months ended June 30, 2025.

Cash, Cash Equivalents, and Marketable Securities. As of June 30, 2026, the Company had $167.6 million in cash, cash equivalents, and marketable securities, providing cash runway into the first half of 2028.

About FHD-909

FHD-909 (LY4050784) is a potent, first-in-class, allosteric, and orally available small molecule that selectively inhibits the ATPase activity of SMARCA2 (BRM) over its closely related paralog SMARCA4 (BRG1), two proteins that are the catalytic engines across all forms of the BAF complex, one of the key regulators of the chromatin regulatory system. In preclinical studies, tumors with mutations in SMARCA4 rely on SMARCA2 for their survival. FHD-909 has shown significant anti-tumor activity across multiple SMARCA4-mutant lung tumor models.

(Press release, Foghorn Therapeutics, AUG 6, 2026, View Source [SID1234669847])