On November 5, 2025 Tempest Therapeutics, Inc. (Nasdaq: TPST), a clinical-stage biotechnology company with a pipeline of first-in-class1 targeted and immune-mediated therapeutics to fight cancer, reported financial results for the quarter ended September 30, 2025 and provided a corporate update.

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"We are continuing our strategic alternatives process with the goal of maximizing value for stockholders," said Stephen Brady, president and chief executive officer of Tempest. "In addition, we look forward to the start of the TPST-1495 Phase 2 in collaboration with the NCI and the Cancer Prevention Clinical Trials Network and remain confident in the potential of amezalpat to transform the treatment of first-line HCC and bring meaningful benefit to patients and their families."

Financial Results

Third Quarter 2025

Tempest ended the quarter with $7.5 million in cash and cash equivalents, compared to $30.3 million on December 31, 2024. The decrease was primarily due to cash used in operating activities, offset by $4.1 million in net proceeds from the June 2025 registered direct offering, as well as $2.8 million in net proceeds from the company’s at-the-market offering program.
Net loss and net loss per share for the quarter were $3.5 million and $0.79, respectively, compared to $10.6 million and $5.32, respectively, for the same period in 2024.
Research and development expenses for the quarter were $0.6 million, compared to $7.6 million for the same period in 2024. The $7.0 million decrease was primarily due to a decrease in costs incurred as a result of re-prioritizing efforts towards exploring strategic alternatives.
General and administrative expenses for the quarter were $3.0 million, compared to $3.0 million for the same period in 2024, and were primarily related to consulting and professional services.
Year-to-Date

Cash used in operating activities for the nine months ended September 30, 2025 was $23.2 million.
Net loss and net loss per share for the nine months ended September 30, 2025 were $22.2 million and $5.71, respectively, compared to $28.0 million and $15.48, respectively, for the same period in 2024.
Research and development expenses for the nine months ended September 30, 2025 were $12.1 million, compared to $17.7 million for the same period in 2024. The $5.6 million decrease was primarily due to a decrease in costs incurred as a result of re-prioritizing efforts towards exploring strategic alternatives.
General and administrative expenses for the nine months ended September 30, 2025 were $10.4 million, compared to $10.4 million for the same period in 2024, and were primarily related to employee compensation costs, inclusive of one-time separation costs for employees terminated during the nine months ended September 30, 2025, as well as consulting and professional services.

(Press release, Tempest Therapeutics, NOV 5, 2025, View Source [SID1234659476])

On November 5, 2025 Tempus AI, Inc. (NASDAQ: TEM), a technology company leading the adoption of AI to advance precision medicine, reported that six abstracts have been accepted for presentation at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting 2025. The meeting is taking place November 5 – 9 at the Gaylord National Convention Center in National Harbor, Maryland.

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"We’re excited to join the oncology community at this year’s meeting and highlight our latest research and progress in advancing the immuno-oncology field," said Ezra Cohen, MD, Chief Medical Officer of Oncology at Tempus. "Our latest findings demonstrate the potential of integrated, data-driven approaches to refine biomarkers, improve prediction of immunotherapy response, and inform the development of next-generation tools for patient stratification."

This year, Tempus will highlight its latest scientific and clinical research findings via six poster presentations.

A novel multi-omic algorithm to predict real-world outcomes among patients with rare, advanced, solid cancers treated with off-label immune checkpoint inhibitors
Date/Time: Friday, November 7, 5:10–6:35 p.m. ET
Location: Exhibit Halls AB
Presentation Number: 157
Summary: This study investigates the utility of the Immune Profile Score (IPS) as a molecular signature to predict the effectiveness of immune checkpoint inhibitor (ICI) therapy in rare, advanced solid cancers. Given the clinical unmet need for rare, heterogeneous cancers, the study evaluated 90 eligible patients from Tempus’ de-identified real-world database who had a rare, advanced solid cancer diagnosis and received off-label ICI treatment, excluding those with high TMB or MSI. Patients were further categorized as IPS-high or IPS-low. The findings demonstrated that IPS-high patients experienced significantly longer overall survival compared to those categorized as IPS-low. Importantly, IPS maintained its prognostic significance across all patient subgroups and clinically relevant confounders. These results support IPS as a pan-cancer biomarker capable of accurately stratifying ICI treatment outcomes and potentially supporting the label expansion of ICIs to various rare cancer types.
MAIT cell abundance within tumors are associated with key clinical characteristics across solid tumors
Date/Time: Friday, November 7, 5:10–6:35 p.m. ET
Location: Exhibit Halls AB
Presentation Number: 133
Summary: An analysis of 190,189 patients, utilizing T-cell receptor (TCR) sequencing data from Tempus’ de-identified real-world database, investigated the prevalence and distribution of mucosal-associated invariant T (MAIT) cells across numerous solid tumor types. The study determined MAIT cell abundance using TCRα chains, with comparisons adjusting for overall T cell infiltration or total TCR’s detected where relevant. MAIT cell abundance was highest in tumors of mucosal origin, such as colorectal and gastroesophageal cancers, and higher MAIT cell levels were statistically significantly in younger patients, males, and non-smokers. Furthermore, the prevalence of MAIT cells showed associations with important clinical and molecular factors, including reduced MAIT cell abundance in PD-L1 high (TPS ≥50%; pan-cancer), microsatellite instability (MSI)-high (pan-cancer and colorectal cancer), and microbial factors such as lower bacterial load (pan-cancer). These findings suggest that MAIT cell prevalence may have important clinical implications and may serve as a promising biomarker and immunotherapy target.
TargetR: Automated multi-omics report framework for target characterization and validation of immunotherapy and targeted therapy candidates across cancers
Date/Time: Friday, November 7; 5:10–6:35 p.m. ET
Location: Exhibit Halls AB
Presentation Number: 1115
Summary: A detailed computational framework, TargetR, was developed by integrating public and real-world multi-omics datasets to accelerate the discovery and validation of immunotherapy targets. This approach unified pharmacologic, genomic, transcriptomic, and proteomic data, utilizing advanced analytics to assess target potential based on criteria such as normal tissue expression, mutational load, and copy number variation (CNV) correlation with expression. Validation of findings can then be performed using Tempus’ de-identified real-world database, which provides clinical features and outcome data. The framework generated an automated, user-friendly report with actionable insights, enabling the identification and prioritization of targets for treatments like bispecific T-cell engagers and CAR-T therapies, thereby supporting the development of next-generation immunotherapies.
A multi-omic immune profile score (IPS) stratifies real-world outcomes of microsatellite stable (MSS) advanced colorectal cancer patients treated with immune checkpoint inhibitors
Date/Time: Saturday, November 8; 5:10–6:35 p.m. ET
Location: Exhibit Halls AB
Presentation Number: 134
Summary: This exploratory study investigated the potential of Tempus’ Immune Profile Score (IPS), a DNA- and RNA-based molecular signature, to act as a predictive biomarker for immune checkpoint inhibitor (ICI) benefit in patients with microsatellite stable (MSS) advanced colorectal cancer (CRC). Tempus’ de-identified real-world database was utilized to identify 46 eligible MSS CRC patients who received an ICI alone or ICI-containing regimen in the third line (3L) or beyond. Using pre-ICI tissue, patients were stratified into IPS-High versus IPS-Low groups. The results demonstrated a clinically meaningful improvement in real-world overall survival (rwOS) for the IPS-High group compared to the IPS-Low group. Furthermore, a comparison of IPS risk stratification on ICI therapy versus prior non-ICI regimen provided additional insight about IPS’s utility as an ICI-specific biomarker. This hypothesis-generating data address an unmet need for patients whom an ICI therapy and predictive biomarker are urgently needed.
Ultrahigh tumor mutational burden (TMB) is associated with improved survival outcomes in patients (Pts) treated with immune checkpoint inhibitors (ICIs)
Date/Time: Saturday, November 8, 2025; 5:10–6:35 p.m. ET
Location: Exhibit Halls AB
Presentation Number: 136
Summary: This research evaluates the prognostic value of defining an "ultrahigh" tumor mutational burden (TMB) threshold (≥40 mutations/MB) compared to the standard 10 mt/MB cutoff for patients receiving immune checkpoint inhibitor (ICI) therapy. Using Tempus Lens, the research team defined a cohort of 17,449 patients with five different cancer types (melanoma, lung, GI, non-melanoma skin, and uterine) from Tempus’ de-identified multimodal database. The analysis sought to compare real-world objective response rates (rwORR) and overall survival (rwOS) across low, high, and ultrahigh TMB groups. The findings indicate that patients in the ultrahigh TMB group experience significantly improved clinical outcomes, including enhanced rwORR and better rwOS. This ultrahigh TMB status is also linked to a distinct tumor microenvironment, specifically showing a higher degree of regulatory T cell and myeloid cell infiltration, suggesting that ultrahigh TMB may serve as a novel marker for predicting ICI responsiveness.
Impact of androgen receptor mutations on immune infiltration in castration resistant prostate cancer
Date/Time: Saturday, November 8; 5:10–6:35 p.m. ET
Location: Exhibit Halls AB
Presentation Number: 140
Summary: A detailed analysis using Tempus’ de-identified real-world database examined the relationship between androgen receptor (AR) alterations and the immune microenvironment in 1,556 patients with castration-resistant prostate cancer (CRPC). The study specifically investigated AR mutations, amplifications, and ARv7 splicing detected via DNA (Tempus xT) and RNA (Tempus xR) sequencing. Over half of the CRPC patients exhibited these AR alterations, which were associated with significantly decreased immune infiltration and reduced expression of key immunotherapy targets like PD−1, PD−L1, and CTLA−4. Regression analysis confirmed this link to decreased immune infiltration was independent of tumor mutational burden (TMB) and tumor purity. These findings suggest that AR mutations contribute to a reduced immune response, potentially serving as a mechanism of resistance to treatment, and underscore the necessity of using AR status to stratify CRPC patients for immunotherapy.

(Press release, Tempus, NOV 5, 2025, View Source [SID1234659493])

On November 5, 2025 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 quarter ended September 30, 2025. The Company also announced that Chief Financial Officer, Kristian Humer, will be departing to pursue another opportunity.

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"This quarter marked continued execution across our portfolio, reinforcing our leadership in developing novel precision therapies with broad applicability across cancers," said Adrian Gottschalk, President and Chief Executive Officer of Foghorn. "FHD-909, in collaboration with Lilly, is advancing in a Phase 1 dose escalation trial for the treatment of SMARCA4-mutated cancers with a focus on NSCLC. Based on our preclinical monotherapy and combination data, we are enthusiastic about the development of FHD-909 with the goal of developing it as a front-line therapy in NSCLC. Our strategic collaboration with Lilly provides the necessary strategic and financial resources to develop FHD-909."

Mr. Gottschalk continued, "Momentum is strong for our wholly-owned, first-in-class selective degrader programs targeting CBP, EP300 and ARID1B with program updates highlighted during our recent virtual investor event. Our Selective CBP degrader, with potential in ER+ breast cancer, entered non-GLP toxicology studies in Q4 2025 and is advancing towards IND in 2026, and our Selective EP300 degrader continues to show broad spectrum efficacy across hematological malignancies and favorable tolerability in preclinical studies, differentiating it from dual CBP/EP300 approaches. Our Selective ARID1B degrader is progressing towards in vivo proof-of-concept in 2026 with potential in up to 5% of all solid tumors including endometrial, gastric, gastroesophageal junction, bladder and non-small cell lung cancer. Backed by our strong balance sheet and a cash runway into 2028, we are focused on delivering breakthrough therapies that harness the broad therapeutic potential of protein degradation and chromatin regulation. Finally, I want to thank Kristian for his leadership and commitment during his time at Foghorn. He has been a valued member of the team, and I wish him well in his future endeavors."

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 alone and implicated in a significant number of solid tumors.
•Phase 1 trial enrolling well. Enrollment in the first-in-human Phase 1 multi-center trial of FHD-909, with NSCLC as the primary target population, is progressing well and the study remains on track.
•Synergistic preclinical data of FHD-909 in combination with pembrolizumab and KRAS inhibitors. Preclinical data demonstrates enhanced anti-tumor activity of FHD-909 in combination with standard-of-care (SoC) chemotherapies, anti-PD-1 pembrolizumab and several novel KRAS inhibitors in NSCLC animal models. The combination data will inform further development plans of FHD-909.

Ongoing strategic collaboration with Lilly. Foghorn is collaborating with Lilly to develop novel oncology medicines, including a U.S. 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 also includes three discovery programs.

Selective CBP degrader program. Foghorn’s Selective CBP degrader selectively targets CBP, an acetyltransferase closely related to EP300 designed to target a synthetic relationship in EP300-mutated cancers, which includes 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. CBP lineage dependencies are also established in several cancers, including ER+ breast cancer.
•Selective CBP degrader program, IND-ready anticipated in 2026. In October 2025, preclinical data for Selective CBP degrader with potential in EP300-mutated cancers and in ER+ breast cancer was presented during a Foghorn virtual investor event which included:
•Highly potent and selective lead candidate CBPd-171 advancing to dose range finding toxicology studies in Q4 2025
•Anti-tumor activity in EP300 mutant solid tumors and in CBP dependent cancers, including promising potential in ER+ breast cancer
•No significant impact on platelet counts and megakaryocytes spared with CBPd-171
•Long Acting Injectable (LAI) formulation optimized for subcutaneous injection weekly or every other week for convenient administration
Selective EP300 degrader program. Foghorn is developing a Selective EP300 degrader 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).
•Selective EP300 Degrader program, with a focus in MM and DLBCL, IND-enabling studies expected in 2026. In October 2025 Foghorn presented efficacy and safety of Selective EP300 degraders in preclinical models of hematological malignancies which included:
•Broad anti-tumor activity in over 70% of all heme sub-lineages tested
•VHL based selective degrader shows impressive efficacy in MM without hematological toxicities including thrombocytopenia
•EP300 degraders show full efficacy in IMiD-resistant MM cell lines
•Tolerability profile with widespread potential for combinations
ARID1B degrader program. Foghorn’s Selective ARID1B degrader selectively targets and degrades ARID1B in 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, gastroesophageal junction, 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.
•Selective ARID1B degrader program advancing towards in vivo proof of concept in 2026. In October 2025, data for Selective ARID1B degrader was presented at the TPD and Induced Proximity Summit and during a Foghorn virtual investor event which included:
•Developed VHL and cereblon based bifunctional degraders with potential for oral delivery
•Selective degradation of ARID1B achieved
•Modulation of downstream target genes following ARID1B degradation

Degrader Platform. Foghorn continues to advance its degrader platform with investments in novel ligases, long-acting injectables, oral delivery, and induced proximity.

Corporate Update

Leadership. Chief Financial Officer, Kristian Humer, will be departing from the company, with his last day being November 14, 2025. A formal search for a successor has begun.

Third Quarter 2025 Financial Highlights

•Collaboration Revenue. Collaboration revenue was $8.2 million for the three months ended September 30, 2025, compared to $7.8 million for the three months ended September 30, 2024. The increase was driven by the continued advancement of programs under the Lilly Collaboration Agreement.

•Research and Development Expenses. Research and development expenses were $20.0 million for the three months ended September 30, 2025, compared to $24.7 million for the three months ended September 30, 2024. The decrease is attributed to a decrease in FHD-286 costs, decreases in personnel-related costs, early development and other research external costs and facilities and IT-related expenses, partially offset by an increase in Lilly-partnered programs.

•General and Administrative Expenses. General and administrative expenses were $6.7 million for the three months ended September 30, 2025, compared to $7.0 million for the three months ended September 30, 2024. This decrease was primarily due to lower facilities and IT related expenses.

•Net Loss. Net loss was $15.8 million for the three months ended September 30, 2025, compared to a net loss of $19.1 million for the three months ended September 30, 2024.

•Cash, Cash Equivalents, and Marketable Securities. As of September 30, 2025, the Company had $180.3 million in cash, cash equivalents, and marketable securities, providing cash runway into 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, NOV 5, 2025, View Source [SID1234659461])

On November 5, 2025 Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) reported results for the quarter ended September 30, 2025.

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Mr. Richard Francis, Teva’s President and CEO, said, "Our innovative portfolio driving the 11th consecutive quarter of growth in the third quarter reflects the accelerating momentum of our transformation and the strength of our innovation-led Pivot to Growth strategy. Our key growth drivers—particularly our innovative medicines—delivered a 33% increase in local currency, underscoring their impact on both patient outcomes and our financial performance. As we continue executing our strategy, we remain firmly on track to reach our 30% non-GAAP operating profit margin by 2027 and ~$700 million of net savings target."

Mr. Francis added, "Following the conclusion of the IRA pricing negotiations, we are reiterating our strong confidence in our AUSTEDO 2027 target. Our differentiated innovative portfolio is now a defining strength for Teva as we transform into a leading innovative biopharma, while our world-class generics business continues to provide a resilient foundation. With our talented team and unwavering commitment to patients, we are confident about Teva’s future and our ability to deliver enduring value to all our stakeholders."

Pivot to Growth Strategy

In the third quarter of 2025, we continued to execute on the four key pillars of our "Pivot to Growth" strategy, announced in May 2023. As part of this strategy, in the second quarter of 2025 Teva entered its "Accelerate Growth" phase, during which we expect to focus on growing our innovative portfolio, aligning capital allocation to invest in activities we expect to have the highest value, and modernizing our organization and operations to drive both efficiency and cost savings.

Delivering on our Growth Engines – on the first pillar, our key innovative brands – AUSTEDO, AJOVY and UZEDY – continued to demonstrate strong performance. Collectively, these products grew ~33% in Q3 2025 YoY in local currency. For AUSTEDO, we are raising the 2025 revenue outlook by $50 million – $100 million to a new range of $2,050 million – $2,150 million. For AJOVY and UZEDY, we are reaffirming our previous outlooks of $630 million – $640 million and $190 million – $200 million, respectively. The conclusion of the IRA pricing negotiations reinforces confidence in our long-term outlook for AUSTEDO. We are on track for our 2027 revenue target of >$2.5 billion for AUSTEDO and peak year revenue target of >$3 billion. During the third quarter of 2025, the FDA approved an expansion of AJOVY’s indication, to include its use as an anti-CGRP preventive treatment for pediatric episodic migraine in patients aged 6 to17 years who weigh 45 kg or more. This approval marks an important step in Teva’s efforts to advance care for neurological conditions.
Stepping Up Innovation – on the second pillar, we continued to accelerate the development of certain key pipeline assets. For olanzapine LAI, we presented new long-term safety data from the SOLARIS Trial with no PDSS observed and anticipate filing its New Drug Application (NDA) in Q4 2025. Teva’s investigational therapy emrusolmin (TEV-56286) received U.S. FDA Fast Track designation for the treatment of Multiple System Atrophy (MSA), a rare and progressive neurodegenerative disease with no approved treatments to slow its progression —another step forward in Teva’s commitment to advancing innovative neuroscience therapies. Phase 3 programs for duvakitug (anti-TL1A) in UC and CD were initiated by Sanofi and Teva in October 2025; on track to achieve target enrollment levels in the adult and pediatric populations for DARI’s (Dual-action Asthma Rescue Inhaler) Phase 3 trial at the end of 2025.
Sustaining Our Generics Powerhouse – on the third pillar, we remain focused on strengthening our world-class global generics business with a streamlined portfolio of high-value complex generics and biosimilars, a robust pipeline, and an integrated global manufacturing and commercial footprint. In the U.S., we received FDA approval and launched liraglutide injection (the generic version of Saxenda), the first-ever generic GLP-1 treatment indicated for weight loss. This milestone strengthens Teva’s complex generics portfolio, expanding access to effective weight management options for adults and adolescents. Our recently launched biosimilars – SIMLANDI (adalimumab-ryvk), SELARSDITM (ustekinumab-aekn) and EPYSQLI (eculizumab-aagh) – continue to grow as does our legacy biosimilar portfolio.
Focusing our Business – Lastly, on the fourth pillar, to accelerate our growth, we are actively transforming and modernizing our business through Teva Transformation programs. On May 7, 2025, we announced that these programs are expected to generate ~$700 million of net savings through 2027. We are on track to achieving our targeted savings for 2025.
Teva continues in its effort to sell its active-pharmaceutical ingredient (API) business. Exclusive discussions with a selected buyer on the sale have terminated. Teva is initiating a renewed sales process, maintaining its strategic intention to divest its API business. On December 31, 2024, Teva classified the business (including its R&D, manufacturing and commercial activities) as held for sale.

Third Quarter 2025 Consolidated Results

Revenues in the third quarter of 2025 were $4,480 million, an increase of 3% in U.S. dollars, or 1% in local currency terms compared to the third quarter of 2024. This increase was mainly due to higher revenues from AUSTEDO and from generic products including biosimilars in our U.S. segment, partially offset by lower revenues from generic products in our International Markets segment due to the divestment of our business venture in Japan, from generic products in our Europe segment, and from certain other innovative products in all of our segments, as well as lower year-over-year proceeds from the sale of certain product rights.

Exchange rate movements during the third quarter of 2025, net of hedging effects, positively impacted revenues by $106 million, compared to the third quarter of 2024.

Exchange rate movements during the third quarter of 2025, including hedging effects, had a positive impact of $21 million on our operating income and non-GAAP operating income compared to the third quarter of 2024.

Gross profit in the third quarter of 2025 was $2,304 million, an increase of 7% compared to $2,148 million in the third quarter of 2024. Gross profit margin was 51.4% in the third quarter of 2025, compared to 49.6% in the third quarter of 2024. Non-GAAP gross profit was $2,475 million in the third quarter of 2025, an increase of 6% compared to $2,327 million in the third quarter of 2024. Non-GAAP gross profit margin was 55.3% in the third quarter of 2025, compared to 53.7% in the third quarter of 2024. The increase in both gross profit margin and non-GAAP gross profit margin was mainly due to higher revenues from AUSTEDO.

Research and Development (R&D) expenses, net in the third quarter of 2025 were $256 million, an increase of 7% compared to $240 million in the third quarter of 2024. Our higher R&D expenses, net in the third quarter of 2025 compared to the third quarter of 2024, were mainly due to an increase in immunology projects, partially offset by a decrease in our late-stage innovative pipeline in neuroscience (mainly neuropsychiatry), which was also impacted by a reimbursement from our strategic partnerships in the third quarter of 2024.

Selling and Marketing (S&M) expenses in the third quarter of 2025 were $656 million, an increase of 5% compared to the third quarter of 2024. This increase was mainly to support revenue growth in our key innovative products and in generic products.

General and Administrative (G&A) expenses in the third quarter of 2025 were $317 million, an increase of 6% compared to the third quarter of 2024. This increase was mainly due to costs related to optimization activities of Teva’s global organization and operations in connection with Teva’s Transformation programs, as well as a negative impact from exchange rate fluctuations.

Other loss in the third quarter of 2025 was $7 million, compared to other income of $21 million in the third quarter of 2024. Other income in the third quarter of 2024 included a capital gain from the sale of a business in our International Markets segment.

Operating income in the third quarter of 2025 was $882 million, compared to an operating loss of $51 million in the third quarter of 2024. Operating income as a percentage of revenues was 19.7% in the third quarter of 2025, compared to an operating loss as a percentage of revenues of 1.2% in the third quarter of 2024. This increase was mainly due to the goodwill impairment charge and higher legal settlements and loss contingencies recorded in the third quarter of 2024. Non-GAAP operating income in the third quarter of 2025 was $1,294 million representing a non-GAAP operating margin of 28.9% compared to $1,214 million representing 28.0%, respectively, in the third quarter of 2024. The increase in non-GAAP operating margin in the third quarter of 2025 was due to higher gross profit margin, partially offset by an increase in operating expenses as a percentage of revenues.

Financial expenses, net in the third quarter of 2025 were $237 million, mainly comprised of net-interest expenses of $209 million. In the third quarter of 2024, financial expenses, net were $272 million, mainly comprised of net-interest expenses of $225 million and a negative exchange rate impact, driven mainly from currencies which we were unable to hedge.

In the third quarter of 2025, we recognized a tax expense of $214 million, on a pre-tax income of $646 million. In the third quarter of 2024, we recognized a tax expense of $69 million, on a pre-tax loss of $324 million.

Non-GAAP tax rate in the third quarter of 2025 was 14.7%, compared to 16.0% in the third quarter of 2024. Our non-GAAP tax rate in the third quarter of 2025 was mainly affected by changes in deferred tax balances due to statutory tax rate changes and interest and inflation adjustments related to the agreement with the Israeli Tax Authorities. Our non-GAAP tax rate in the third quarter of 2024 was mainly affected by the generation of profits in various jurisdictions with different tax rates, an adjustment to Teva’s corporate tax rate in Israel on losses related to non-qualified tax incentive activities in Israel, recording of valuation allowance with respect to certain carry over credits outside of Israel, as well as infrequent or non-recurring items.

We expect our annual non-GAAP tax rate for 2025 to be between 15%-18%, slightly higher than our non-GAAP tax rate for 2024, which was 15.3%, mainly due to a net tax benefit related to deferred tax assets resulting from intellectual property-related integration plans in 2024.

Net income attributable to Teva and diluted earnings per share in the third quarter of 2025 were $433 million and $0.37, respectively, compared to a net loss attributable to Teva and loss per share of $437 million and $0.39, respectively, in the third quarter of 2024. This change was mainly due to higher operating income in the third quarter of 2025, partially offset by higher income taxes, as discussed above. Non-GAAP net income attributable to Teva and non-GAAP diluted earnings per share in the third quarter of 2025 were $910 million and $0.78, respectively, compared to $798 million and $0.69, respectively, in the third quarter of 2024.

Adjusted EBITDA was $1,394 million in the third quarter of 2025, an increase of 5%, compared to $1,327 million in the third quarter of 2024.

As of September 30, 2025 and 2024, the fully diluted share count for purposes of calculating our market capitalization was approximately 1,184 million shares and 1,167 million shares, respectively.

Non-GAAP information: non-GAAP adjustments for non-GAAP net income attributable to Teva and non-GAAP diluted EPS in the third quarter of 2025 were $478 million and consisted of the following adjustments:

Amortization of purchased intangible assets of $144 million, of which $134 million is included in cost of sales and the remaining $10 million in S&M expenses;
Impairment of long-lived assets of $79 million;
Legal settlements and loss contingencies of $60 million;
Contingent consideration expenses of $16 million;
Equity compensation expenses of $34 million;
Restructuring expenses of $29 million;
Financial expenses of $7 million;
Other non-GAAP items of $51 million; and
Corresponding tax effects and unusual tax items of $58 million.
We believe that excluding such items facilitates investors’ understanding of our business including underlying trends, thereby improving the comparability of our business performance results between reporting periods.

For a reconciliation of the U.S. GAAP results to the adjusted non-GAAP figures and for additional information, see the tables below and the information included under "Non-GAAP Financial Measures." Investors should consider non-GAAP financial measures in addition to, and not as replacement for, or superior to, measures of financial performance prepared in accordance with GAAP.

Cash flow generated from operating activities during the third quarter of 2025 was $369 million, compared to $693 million in the third quarter of 2024. The lower cash flow generated from operating activities in the third quarter of 2025 was mainly due to timing of sales and collections, as well as higher legal settlement payments, partially offset by lower tax payments and higher profit.

During the third quarter of 2025, we generated free cash flow of $515 million, which we define as comprising $369 million in cash flow generated from operating activities, $274 million in beneficial interest collected in exchange for securitized accounts receivables (under our EU securitization program) and $8 million of proceeds from divestitures of businesses and other assets, partially offset by $136 million in cash used for capital investment. During the third quarter of 2024, we generated free cash flow of $922 million, which we define as comprising $693 million in cash flow generated from operating activities, $339 million in beneficial interest collected in exchange for securitized accounts receivables (under our EU securitization program) and $38 million in divestitures of businesses and other assets, partially offset by $148 million in cash used for capital investment. The decrease in the third quarter of 2025 mainly resulted from lower cash flow generated from operating activities, as well as a decrease in proceeds from divestitures of businesses and other assets.

As of September 30, 2025, our debt was $16,790 million, compared to $17,783 million as of December 31, 2024. This decrease was mainly due to repayment at maturity of $1,812 million of our senior notes, partially offset by an increase of $791 million due to exchange rate fluctuations. Additionally, during the second quarter of 2025, we repurchased $2,290 million aggregate principal amount of notes upon consummation of a cash tender offer, and issued $2,298 million of senior notes, net of discount and issuance costs. The portion of total debt classified as short-term as of September 30, 2025 was negligible compared to 10% as of December 31, 2024. Our average debt maturity was approximately 5.85 years as of September 30, 2025, compared to 5.5 years as of December 31, 2024.

Segment Results for the Third Quarter of 2025

United States Segment

The following table presents revenues, expenses and profit for our United States segment for the three months ended September 30, 2025 and 2024:

Three months ended September 30,
2025 2024
(U.S. $ in millions / % of Segment Revenues)
Revenues $ 2,483 100% $ 2,225 100%
Cost of sales 996 40.1% 960 43.1%
Gross profit 1,486 59.9% 1,265 56.9%
R&D expenses 161 6.5% 151 6.8%
S&M expenses 278 11.2% 259 11.6%
G&A expenses 114 4.6% 107 4.8%
Other (3) § § §
Segment profit* $ 937 37.7% $ 748 33.6%
* Segment profit does not include amortization and certain other items.
§ Represents an amount less than $0.5 million or 0.5%, as applicable.

Revenues from our United States segment in the third quarter of 2025 were $2,483 million, an increase of $257 million, or 12%, compared to the third quarter of 2024. This increase was mainly due to higher revenues from our key innovative products, primarily AUSTEDO, and generic products including biosimilars.

Revenues by Major Products and Activities

The following table presents revenues for our United States segment by major products and activities for the three months ended September 30, 2025 and 2024:

Three months ended
September 30, Percentage
Change
2025 2024 2025-2024
(U.S. $ in millions)

Generic products (including biosimilars) $ 1,175 $ 1,094 7%
AJOVY 73 58 27%
AUSTEDO 601 435 38%
BENDEKA and TREANDA 35 40 (13%)
COPAXONE 62 69 (9%)
UZEDY 43 35 24%
Anda 392 380 3%
Other 101 115 (13%)
Total $ 2,483 $ 2,225 12%

Generic products (including biosimilars) revenues in our United States segment in the third quarter of 2025 were $1,175 million, an increase of 7% compared to the third quarter of 2024. This increase was mainly driven by higher revenues from our portfolio of biosimilar products.

Among the most significant generic products we sold in the United States in the third quarter of 2025 were lenalidomide capsules (the generic version of Revlimid), epinephrine injectable solution (the generic equivalent of EpiPen and EpiPen Jr) and Truxima (the biosimilar to Rituxan). In the third quarter of 2025, our total prescriptions were approximately 261 million (based on trailing twelve months), representing 6.7% of total U.S. generic prescriptions, compared to approximately 292 million (based on trailing twelve months), representing 7.6% of total U.S. generic prescriptions in the third quarter of 2024, all according to IQVIA data.

AJOVY revenues in our United States segment in the third quarter of 2025 were $73 million, an increase of 27% compared to the third quarter of 2024, mainly due to growth in volume. In the third quarter of 2025, AJOVY’s exit market share in the United States in terms of total number of prescriptions was 32.0% out of the subcutaneous injectable anti-CGRP class, compared to 29.1% in the third quarter of 2024. In August 2025, the FDA approved AJOVY for the preventive treatment of episodic migraine in children and adolescent patients aged 6 to 17 years.

AUSTEDO revenues (which include AUSTEDO XR) in our United States segment in the third quarter of 2025 were $601 million, an increase of 38%, compared to $435 million in the third quarter of 2024. This increase was mainly due to growth in volumes.

During the third quarter of 2025, Teva and the Centers for Medicare and Medicaid Services ("CMS") negotiated a maximum fair price for the AUSTEDO products, based on CMS’s list of prescription medicines selected for price-setting discussions, in which they were originally included. The agreement is expected to be announced by CMS in November 2025. The revised prices set by the U.S. Government, will become effective January 1, 2027 and will apply to eligible Medicare patients.

AUSTEDO XR (deutetrabenazine) extended-release tablets was approved by the FDA on February 17, 2023 in three doses of 6, 12 and 24 mg, and became commercially available in the U.S. in May 2023. The FDA approved AUSTEDO XR as a one pill, once-daily treatment option in doses of 30, 36, 42, and 48 mg in May 2024 and in a 18 mg dose in July 2024. AUSTEDO XR is a once-daily formulation indicated in adults for tardive dyskinesia and chorea associated with Huntington’s disease, in addition to the currently marketed twice-daily AUSTEDO. AUSTEDO XR is protected by 11 Orange Book patents expiring between 2031 and 2041.

UZEDY (risperidone) extended-release injectable suspension revenues in our United States segment in the third quarter of 2025 were $43 million, an increase of 24% compared to the third quarter of 2024, mainly due to growth in volume.

BENDEKA and TREANDA combined revenues in our United States segment in the third quarter of 2025 were $35 million, a decrease of 13% compared to the third quarter of 2024, mainly due to competition from alternative therapies, as well as from generic bendamustine products.

COPAXONE revenues in our United States segment in the third quarter of 2025 were $62 million, a decrease of 9% compared to the third quarter of 2024, mainly due to competition.

Anda revenues from third-party products in our United States segment in the third quarter of 2025 were $392 million, an increase of 3%, compared to $380 million in the third quarter of 2024. This increase was mainly due to higher volumes. Anda, our distribution business in the United States, distributes generic and innovative medicines and OTC pharmaceutical products from Teva and various third-party manufacturers to independent retail pharmacies, pharmacy retail chains, hospitals and physician offices in the United States.

United States Gross Profit

Gross profit from our United States segment in the third quarter of 2025 was $1,486 million, an increase of 17%, compared to $1,265 million in the third quarter of 2024.

Gross profit margin for our United States segment in the third quarter of 2025 increased to 59.9%, compared to 56.9% in the third quarter of 2024. This increase was mainly due to a favorable mix of products primarily driven by higher revenues from AUSTEDO.

United States Profit

Profit from our United States segment consists of revenues less cost of sales, R&D expenses, S&M expenses, G&A expenses and other expenses (income) related to this segment. Segment profit does not include amortization and certain other items.

Profit from our United States segment in the third quarter of 2025 was $937 million, an increase of 25% compared to $748 million in the third quarter of 2024. This increase was mainly due to higher gross profit, as discussed above.

Europe Segment

Our Europe segment includes the European Union, the United Kingdom and certain other European countries.

The following table presents revenues, expenses and profit for our Europe segment for the three months ended September 30, 2025 and 2024:

Three months ended September 30,
2025 2024
(U.S. $ in millions / % of Segment Revenues)
Revenues $ 1,235 100% $ 1,265 100%
Cost of sales 570 46.1% 566 44.8%
Gross profit 665 53.9% 698 55.2%
R&D expenses 62 5.0% 55 4.3%
S&M expenses 225 18.2% 203 16.0%
G&A expenses 75 6.1% 67 5.3%
Other § § 1 §
Segment profit* $ 303 24.5% $ 373 29.5%
* Segment profit does not include amortization and certain other items.
§ Represents an amount less than $0.5 million or 0.5%, as applicable.

Revenues from our Europe segment in the third quarter of 2025 were $1,235 million, a decrease of 2%, or $30 million, compared to the third quarter of 2024. In local currency terms, revenues decreased by 10% compared to the third quarter of 2024, mainly due to higher proceeds from the sale of certain product rights in the third quarter of 2024, and lower revenues from generic products, partially offset by higher revenues from AJOVY.

In the third quarter of 2025, revenues were positively impacted by exchange rate fluctuations of $91 million, including hedging effects, compared to the third quarter of 2024. Revenues in the third quarter of 2025, included $6 million from a positive hedging impact, which is included in "Other" in the table below. Revenues in the third quarter of 2024 included $10 million from a negative hedging impact, which is included in "Other" in the table below.

Revenues by Major Products and Activities
The following table presents revenues for our Europe segment by major products and activities for the three months ended September 30, 2025 and 2024:

Three months ended
September 30, Percentage
Change
2025 2024 2025-2024
(U.S. $ in millions)
Generic products (including OTC and biosimilars) $ 982 $ 973 1%
AJOVY 66 56 18%
COPAXONE 44 53 (18%)
Respiratory products 52 60 (13%)
Other* 91 124 (26%)
Total $ 1,235 $ 1,265 (2%)
*Other revenues in the third quarter of 2025 and 2024 include the sale of certain product rights.

Generic products revenues (including OTC and biosimilar products) in our Europe segment in the third quarter of 2025 were $982 million, an increase of 1% compared to the third quarter of 2024. In local currency terms, revenues decreased by 5%, mainly due to lower volumes and price reductions as a result of market dynamics and lower sales of seasonal OTC products, partially offset by higher revenues from recently launched products.

AJOVY revenues in our Europe segment in the third quarter of 2025 increased by 18% to $66 million, compared to $56 million in the third quarter of 2024. In local currency terms revenues increased by 11% due to growth in volume.

COPAXONE revenues in our Europe segment in the third quarter of 2025 were $44 million, a decrease of 18% compared to the third quarter of 2024. In local currency terms revenues decreased by 23%, due to price reductions and lower volumes resulting from the availability of alternative therapies.

Respiratory products revenues in our Europe segment in the third quarter of 2025 were $52 million, a decrease of 13% compared to the third quarter of 2024. In local currency terms, revenues decreased by 18%, mainly due to net price reductions and lower volumes associated with the availability of alternative therapies.

Europe Gross Profit

Gross profit from our Europe segment in the third quarter of 2025 was $665 million, a decrease of 5% compared to $698 million in the third quarter of 2024.

Gross profit margin for our Europe segment in the third quarter of 2025 decreased to 53.9%, compared to 55.2% in the third quarter of 2024. This decrease was mainly due to higher proceeds from the sale of certain product rights in the third quarter of 2024, and an unfavorable mix of products, partially offset by a positive impact from hedging activities.

Europe Profit

Profit from our Europe segment consists of revenues less cost of sales, R&D expenses, S&M expenses, G&A expenses and other expenses (income) related to this segment. Segment profit does not include amortization and certain other items.

Profit from our Europe segment in the third quarter of 2025 was $303 million, a decrease of 19%, compared to $373 million in the third quarter of 2024. This decrease was mainly due to lower gross profit and higher S&M expenses.

International Markets Segment

Our International Markets segment includes all countries in which we operate other than the United States and the countries included in our Europe segment. The International Markets segment covers a substantial portion of the global pharmaceutical industry, including more than 35 countries.

The countries in our International Markets segment include highly regulated, mainly generic markets, such as Canada and Israel, and branded generics-oriented markets, such as Russia and certain Latin America markets.

On March 31, 2025, we divested our Teva-Takeda business venture in Japan, which included generic products and legacy products.

The following table presents revenues, expenses and profit for our International Markets segment for the three months ended September 30, 2025 and 2024:

Three months ended September 30,
2025 2024
(U.S. $ in millions / % of Segment Revenues)
Revenues $ 557 100% $ 613 100%
Cost of sales 280 50.2% 307 50.1%
Gross profit 278 49.8% 306 49.9%
R&D expenses 26 4.6% 27 4.4%
S&M expenses 122 21.9% 134 21.9%
G&A expenses 36 6.4% 36 5.8%
Other § § § §
Segment profit* $ 95 17.0% $ 109 17.8%
* Segment profit does not include amortization and certain other items.

§ Represents an amount less than $0.5 million or 0.5%, as applicable.

Revenues from our International Markets segment in the third quarter of 2025 were $557 million, a decrease of 9%, or 10% in local currency terms compared to the third quarter of 2024. This decrease was mainly due to the divestment of our business venture in Japan, partially offset by higher revenues, mainly from generic products in other markets.

In the third quarter of 2025, revenues were positively impacted by exchange rate fluctuations of $9 million, including hedging effects, compared to the third quarter of 2024. Revenues in the third quarter of 2025 included $2 million from a positive hedging impact, compared to a positive hedging impact of $1 million in the third quarter of 2024, which are included in "Other" in the table below

The following table presents revenues for our International Markets segment by major products and activities for the three months ended September 30, 2025 and 2024:

Three months ended
September 30, Percentage
Change
2025 2024 2025-2024
(U.S. $ in millions)
Generic products (including OTC and biosimilars) $ 421 $ 477 (12%)
AJOVY 30 24 23%
AUSTEDO 17 13 32%
COPAXONE 8 13 (40%)
Other* 82 86 (4%)
Total $ 557 $ 613 (9%)
*Other revenues in the third quarter of 2025 and 2024 include the sale of certain product rights.

Generic products revenues (including OTC and biosimilar products) in our International Markets segment were $421 million in the third quarter of 2025, a decrease of 12% in U.S. dollars. In local currency terms revenues decreased by 13%, compared to the third quarter of 2024, mainly due to the divestment of our business venture in Japan, partially offset by higher revenues in other markets.

AJOVY was launched in certain markets in our International Markets segment, including in Canada, Japan, Australia, Israel, South Korea, Brazil and others. AJOVY revenues in our International Markets segment in the third quarter of 2025 were $30 million, compared to $24 million in the third quarter of 2024. In local currency terms, revenues increased by 21%, mainly due to growth in existing markets in which AJOVY was launched.

AUSTEDO was launched in China and Israel in 2021 and in Brazil in 2022, for the treatment of chorea associated with Huntington’s disease and for the treatment of tardive dyskinesia. In February 2024, we announced a strategic partnership for the marketing and distribution of AUSTEDO in China with Jiangsu Nhwa Hexin Pharmaceutical Marketing Co., Ltd. In April 2025, AUSTEDO received marketing authorization in South Korea. We continue to pursue additional submissions in various other markets.

AUSTEDO revenues in our International Markets segment in the third quarter of 2025 were $17 million compared to $13 million in the third quarter of 2024. In local currency terms, revenues increased by 31%.

COPAXONE revenues in our International Markets segment in the third quarter of 2025 were $8 million compared to $13 million in the third quarter of 2024.

International Markets Gross Profit

Gross profit from our International Markets segment in the third quarter of 2025 was $278 million, a decrease of 9% compared to $306 million in the third quarter of 2024.

Gross profit margin for our International Markets segment in the third quarter of 2025 decreased to 49.8%, compared to 49.9% in the third quarter of 2024.

International Markets Profit

Profit from our International Markets segment consists of revenues less cost of sales, R&D expenses, S&M expenses, G&A expenses and other expenses (income) related to this segment. Segment profit does not include amortization and certain other items.

Profit from our International Markets segment in the third quarter of 2025 was $95 million, a decrease of 13%, compared to $109 million in the third quarter of 2024. This decrease was mainly due to the divestment of our business venture in Japan.

Other Activities

We have other sources of revenues, primarily the sale of APIs to third parties, certain contract manufacturing services and an out-licensing platform offering a portfolio of products to other pharmaceutical companies through our affiliate Medis. Our other activities are not included in our United States, Europe or International Markets segments described above.

On January 31, 2024, we announced that we intend to divest our API business (including its R&D, manufacturing and commercial activities) through a sale. The intention to divest is in alignment with our Pivot to Growth strategy. As of the date of this Press Release, exclusive discussions with a selected buyer on the sale have terminated. Teva is initiating a renewed sales process, maintaining its strategic intention to divest its API business. However, there can be no assurance regarding the ultimate timing or structure of a potential divestiture or that a divestiture will be agreed or completed at all.

Revenues from other activities in the third quarter of 2025 were $205 million, a decrease of 10% in U.S. dollars, or 13% in local currency terms, compared to the third quarter of 2024, mainly due to a decrease in revenues from contract manufacturing services in the third quarter of 2025.

API sales to third parties in the third quarter of 2025 were $125 million, a decrease of 4% in both U.S. dollars and local currency terms, compared to the third quarter of 2024.

Outlook for 2025 Non-GAAP Results

$ billions, except EPS or as noted January 2025 May 2025 July 2025 November 2025
Revenues* $16.8 – $17.4 $16.8 – $17.2 $16.8 – $17.2 $16.8 – $17.0
AUSTEDO ($m)* 1,900-2,050 1,950-2,050 2,000-2,050 2,050-2,150
AJOVY ($m)* ~600 ~600 630-640 630-640
UZEDY ($m)* ~160 ~160 190-200 190-200
COPAXONE ($m)* ~370 ~370 ~370 ~370
Operating Income 4.1 – 4.6 4.3 – 4.6 4.3 – 4.6 4.4 – 4.6
Adjusted EBITDA 4.5 – 5.0 4.7 – 5.0 4.7 – 5.0 4.8 – 5.0
Tax Rate 15%-18% 15%-18% 15%-18% 15%-18%
Finance Expenses ~0.9 ~0.9 ~0.9 ~0.9
Diluted EPS ($) 2.35 – 2.65 2.45 – 2.65 2.50 – 2.65 2.55 – 2.65
Free Cash Flow** 1.6 – 1.9 1.6 – 1.9 1.6 – 1.9 1.6 – 1.9
CAPEX* ~0.5 ~0.5 ~0.5 ~0.5
Foreign Exchange Volatile swings in FX can negatively impact revenue and income
* Revenues and CAPEX presented on a GAAP basis.

** Free Cash Flow includes cash flow generated from operating activities net of capital expenditures and deferred purchase price cash component collected for securitized trade receivables.

Conference Call

Teva will host a conference call and live webcast along with a slide presentation on Wednesday, November 5, 2025 at 8:00 a.m. ET to discuss its third quarter 2025 financial results and overall business environment.

A question & answer session will follow.

In order to participate, please register in advance here to obtain a local or toll‐free phone number and your personal pin.

A live webcast of the call will be available on Teva’s website at: www.tevapharm.com

Following the conclusion of the call, a replay of the webcast will be available within 24 hours on Teva’s website.

(Press release, Teva, NOV 5, 2025, View Source [SID1234659477])

On November 5, 2025 Adicet Bio, Inc. (Nasdaq: ACET), a clinical stage biotechnology company discovering and developing allogeneic gamma delta T cell therapies for autoimmune diseases and cancer, reported financial results and operational highlights for the third quarter ended September 30, 2025.

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"We were pleased to announce positive preliminary data last month from seven SLE and LN patients treated in our Phase 1 trial of ADI-001, underscoring its broad potential as a transformative, off-the-shelf, one-time therapy for autoimmune diseases. We are now preparing to discuss the trial design for a potentially pivotal study of ADI-001 with the FDA in the first quarter of 2026, with initiation targeted for the second quarter of 2026," said Chen Schor, President and Chief Executive Officer of Adicet Bio. "As part of our broader clinical strategy, we are also exploring the potential to reduce or eliminate the need for conditioning with a separate Phase 1 trial of ADI-001 in treatment-refractory RA patients. We are actively enrolling patients in our Phase 1 trial across LN, SLE, SSc, IIM, SPS and AAV patients, with a clinical update for LN, SLE and SSc expected in the first half of 2026."

Mr. Schor continued: "In addition, we are continuing to advance ADI-212, an optimized next-generation gene-edited and armored clinical candidate designed to target prostate specific membrane antigen, and expect to submit a regulatory filing for the mCRPC program in the first quarter of 2026 and share initial clinical data in the second half of 2026, subject to regulatory clearance. ADI-212 is designed to enhance potency in solid tumors and deliver multiple anti-tumor mechanisms of action to the tumor microenvironment. Supported by our recent capital raise in October, which extended our cash runway into the second half of 2027, we are well-positioned to continue clinical execution across our pipeline of differentiated gamma delta 1 CAR T therapies."

Third Quarter 2025 and Recent Operational Highlights:

Autoimmune diseases

Announced positive preliminary data in LN and SLE patients from Phase 1 study of ADI-001 in autoimmune diseases. In October 2025, Adicet announced positive initial safety and efficacy data from seven patients (five LN and two SLE patients) dosed with ADI-001 in the ongoing Phase 1 trial, with follow-up ranging from two to nine months as of the August 31, 2025 data cut-off date. All patients demonstrated rapid and sustained reductions in the SLEDAI-2K score and PGA. All patients in the LN cohort achieved improved renal function, including three complete renal responses and Definition of Remission In Systemic lupus erythematosus (DORIS) remissions, and two partial responses. ADI-001 also demonstrated multiple hallmarks of immune reset with subsequent emergence of naïve and previously undetected B cell repertoire following single dose treatment. ADI-001 was generally well tolerated and demonstrated a favorable safety profile, with no Grade 2 or higher Cytokine Release Syndrome (CRS), and no cases of Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS) observed.
Based on these results, the Company plans to request a meeting with the FDA in the first quarter of 2026 to inform potential Phase 2 pivotal trial design, with the initiation of the study in LN or LN and SLE patients anticipated to commence in the second quarter of 2026.

Enrollment ongoing in ADI-001 Phase 1 program. Adicet is actively enrolling patients in its Phase 1 clinical trial evaluating ADI-001 in autoimmune diseases which include: LN, SLE, SSc, IIM, SPS and AAV. Adicet expects to provide an LN and SLE clinical update as well as an SSc clinical update in the first half of 2026.
Actively enrolling patients with treatment-refractory RA in Phase 1 study of ADI-001 evaluating potential to reduce the need for conditioning. The Company is enrolling patients with treatment-refractory RA in a Phase 1 study of ADI-001 evaluating two lymphodepletion regimens: cyclophosphamide alone and cyclophosphamide with fludarabine. Adicet expects to provide a clinical update on the Phase 1 trial in the second half of 2026.
Solid tumor indications

Presented ADI-212 preclinical data at the 32nd annual Prostate Cancer Foundation Scientific Retreat. Adicet is continuing to advance preclinical development of ADI-212, an optimized next-generation gene-edited and armored clinical candidate designed to target PSMA. ADI-212 is engineered to express a novel CAR binder designed to support enhanced tolerability and tumor-specific recognition. It integrates membrane-tethered IL-12 (mbIL-12) armoring and CRISPR/Cas9 mediated disruption of subunit 12 of the mediator complex (MED12) to enhance potency in solid tumors and deliver multiple anti-tumor mechanisms of action within the tumor microenvironment. In October, Adicet presented preclinical data at the 32nd Annual Prostate Cancer Foundation Scientific Retreat supporting these design elements and functional enhancements in multiple models of disease.
Regulatory filing on track for ADI-212 in mCRPC. Adicet plans to submit a regulatory filing for ADI-212 for the treatment of mCRPC in the first quarter of 2026. The Company expects to share initial clinical data from the ADI-212 program in the second half of 2026, subject to regulatory clearance to proceed with a clinical trial.
Corporate updates

Raised $74.8 million in net proceeds in registered direct offering. In October 2025, Adicet successfully raised $74.8 million in net proceeds through an underwritten registered direct offering of equity securities, extending its cash runway into the second half of 2027.
Financial Results for Third Quarter 2025:

Research and Development (R&D) Expenses: R&D expenses were $22.9 million for the three months ended September 30, 2025, compared to $26.3 million during the same period in 2024. The decrease in R&D expenses was due to a $1.8 million decrease in payroll and personnel expenses, and a $1.0 million decrease in lab supplies and materials related to lower headcount, a $0.7 million decrease in expenses related to contract development and manufacturing organizations (CDMOs) and contracted R&D services due to lower utilization at external CDMOs, a $0.7 million decrease in expenses related to R&D consultants, partially offset by a $0.8 million of expenses related to contract research organizations; and a $0.1 million decrease in facility-related expenses.
General and Administrative (G&A) Expenses: G&A expenses were $5.1 million for the three months ended September 30, 2025, compared to $6.9 million during the same period in 2024. The decrease in G&A expenses was primarily due to a $1.6 million decrease in payroll and personnel expenses primarily related to a decrease in stock-based compensation expense, and a $0.1 million decrease in facility-related expenses.
Net Loss: Net loss for the three months ended September 30, 2025 was $26.9 million, or a net loss of $0.29 per basic and diluted share, including non-cash stock-based compensation expense of $2.5 million, as compared to a net loss of $30.5 million, or a net loss of $0.34 per basic and diluted share, including non-cash stock-based compensation expense of $6.8 million during the same period in 2024.
Cash Position: Cash, cash equivalents and short-term investments were $103.1 million as of September 30, 2025, compared to $176.3 million as of December 31, 2024. Subsequent to September 30, the Company received approximately $74.8 million of net proceeds from a registered direct offering. The Company expects that its cash and cash equivalents and short-term investments as of September 30, 2025, together with the proceeds raised after quarter end, will be sufficient to fund its operating expenses into the second half of 2027.

(Press release, Adicet Bio, NOV 5, 2025, View Source [SID1234659494])