Generate Biomedicines Reports Third Quarter 2026 Financial Results and Provides Business Update

On November 12, 2026 Generate Biomedicines, Inc. (NASDAQ:GENB) ("Generate") reported financial results for the third quarter ended Sept. 30, 2026, and provided an update on recent business progress.

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"Our third quarter results reflect both strong execution across all of our clinical programs and our continued efforts to push the frontiers of programmable biology and therapeutic intelligence," said Mike Nally, chief executive officer of Generate Biomedicines. "We are making strong progress with GB-0895 in severe asthma, and the data we shared at ERS in COPD further demonstrated the sustained pharmacological activity to support robust modulation of key biomarkers and twice-a-year dosing. At the same time, our scientists are extending the impact of our platform, from new CAR T engineering to our collaboration with Anthropic on agentic science. We start with what a therapy needs to do, then engineer and test the biology to get there."

Recent Progress

GB-0895 in severe asthma and COPD

GB-0895, Generate’s most advanced internal drug candidate, is an investigational anti-TSLP monoclonal antibody engineered with AI for dosing twice a year. The two global Phase 3 SOLAIRIA studies are ongoing in adults and adolescents with severe uncontrolled asthma, and recent Phase 1b results in COPD patients highlight an opportunity to expand into a large and underserved patient population.

Generate presented three posters on GB-0895 at the European Respiratory Society Congress, held Sept. 5–9, 2026, in Barcelona, Spain.

Phase 1 asthma findings. Complete Phase 1 findings showed that a single dose of GB-0895 sustained inflammatory biomarker reductions for at least six months in participants with mild-to-moderate asthma. At 300 mg, GB-0895 achieved maximal biomarker suppression and had a half-life of approximately 98 days, supporting the dosing interval being evaluated in Phase 3.
Phase 1b COPD findings. A single dose of GB-0895 sustained inflammatory biomarker reductions for at least six months in participants with COPD. Comparable suppression was demonstrated for 300 mg and 600 mg, extending the evidence supporting six-month pharmacological activity to a second respiratory indication.
SOLAIRIA Phase 3 study design. The study-design poster detailed the ongoing SOLAIRIA-1 and SOLAIRIA-2 trials in adults and adolescents with severe uncontrolled asthma. The replicate trials evaluate 300 mg administered every 26 weeks, with annualized asthma exacerbation rate over 52 weeks as the primary endpoint.

Zealand Pharma collaboration in obesity and metabolic diseases

On Oct. 13, Generate and Zealand Pharma announced a collaboration and license agreement providing Generate with $30 million upfront and up to $35 million in early preclinical milestones within nearly $1.2 billion in total potential milestone payments, plus tiered royalties on future worldwide net sales of any commercialized products.

The agreement covers two initial programs to develop multispecific protein therapeutics for obesity and other metabolic diseases, with an option to add a third for additional financial consideration. Generate will lead research through lead-candidate selection. Zealand will assume responsibility for subsequent preclinical and clinical development, regulatory submissions, and worldwide commercialization.

Anthropic collaboration and AI-driven CAR T-cell research

On Oct. 27, Generate and Anthropic announced a research collaboration to explore a novel application of an agentic approach to advance next-generation CAR T-cell research.

In early preclinical research, a team of six Generate scientists combined AI agents with the company’s computational and experimental capabilities over approximately six months to engineer a CAR signaling domain approximately 70% shorter than the second-generation design used for comparison. In laboratory tests, CAR T cells incorporating the compact domain showed improved tumor-cell killing compared with the comparison design.

The research also supported expression of four different CARs from a shared mRNA dose, suggesting potential applications in designs targeting multiple tumor antigens. The collaboration focuses on selecting and validating antigen combinations for early-stage solid tumors.

Oncology pipeline advances

GB-4362 aims to address treatment-limiting toxicities associated with antibody-drug conjugates, while GB-5267 is designed to address the difficulty of sustaining CAR T-cell activity in solid tumors.

GB-4362 advanced to the second of potentially three dose-escalation cohorts. Enrollment has begun in the second cohort of the Phase 1 study evaluating GB-4362 with enfortumab vedotin and pembrolizumab in advanced urothelial cancer.
On Oct. 23, Generate presented a trial-in-progress poster describing the Phase 1 clinical study design of GB-4362 at the 2026 European Society for Medical Oncology Congress in Madrid.
On Oct. 1, Generate and Roswell Park Comprehensive Cancer Center announced that the first patient had been dosed in the Phase 1 study of the investigational autologous IL-18-armored CAR T-cell therapy in platinum-resistant ovarian cancer. GB-5267 targets MUC16, an antigen overexpressed in more than 80% of ovarian tumors, and was engineered with AI to optimize tumor-cell killing, T-cell expansion, and persistence. The trial begins the clinical evaluation of that function-first design without requiring chemotherapy-based lymphodepletion.
On Oct. 18, Roswell Park delivered an oral presentation at the 16th Biennial Rivkin Ovarian Cancer Research Symposium in Philadelphia detailing the scientific rationale and study design. The presentation highlighted IL-18 armoring intended to support CAR T-cell activity and a Phase 1 study evaluating GB-5267 without chemotherapy-based lymphodepletion
"We continue to advance GB-0895 through the Phase 3 SOLAIRIA studies in severe asthma and make progress across our clinical pipeline. Following the quarter-end, we also entered into a new collaboration agreement with Zealand Pharma," said Jason Silvers, president and chief financial officer of Generate Biomedicines. "Dosing is underway in cohort 2 of GB-4362, and our first patient has been dosed in the GB-5267 study with Roswell Park. Under the Zealand agreement, Generate received a $30 million upfront payment in October, may receive additional near-term milestones, and is now partnered to explore multispecific protein therapeutics for obesity and metabolic disease. We plan to continue pursuing partnerships that apply our platform to new therapeutic areas, advance differentiated medicines, and provide non-equity-dilutive capital to support our internal programs."

Financial Results

Cash, cash equivalents, and marketable securities were $404.2 million as of Sept. 30, 2026, compared with $457.4 million as of June 30, 2026. Generate believes its existing cash, cash equivalents, and marketable securities, together with the $30.0 million upfront payment received from Zealand in October 2026 in connection with the Zealand collaboration, will be sufficient to fund its current operating plan into the first half of 2028. Generate expects to require additional capital to support long-term operations.

Revenue for the quarter ended Sept. 30, 2026, was $4.2 million, compared with $9.6 million for the same period in 2025. This revenue reflects developments in the ongoing Amgen and Novartis research programs and that Generate is near completion of its performance obligations under both agreements.

Research and development expenses were $82.3 million for the quarter ended Sept. 30, 2026, compared with $62.2 million for the same period in 2025. The increase was driven primarily by continued investment in the GB-0895 Phase 3 SOLAIRIA clinical trials in severe asthma and was partially offset by a decrease in external discovery and other program related costs.

General and administrative expenses were $13.5 million for the quarter ended Sept. 30, 2026, compared with $10.3 million for the same period in 2025. The increase was driven primarily by an increase in stock-based compensation.

Net loss was $87.7 million for the quarter ended Sept. 30, 2026, compared with $60.0 million for the same period in 2025. These amounts include noncash stock-based compensation expense of $8.1 million and $4.8 million, respectively.

(Press release, Generate Biomedicines, NOV 12, 2026, View Source [SID1234674696])

Immuneering Announces New Potentially Registrational Phase 2 Trial Evaluating Atebimetinib with Chemotherapy in Anaplastic Thyroid Cancer

On November 12, 2026 Immuneering Corporation (Nasdaq: IMRX), a late-stage clinical oncology company focused on keeping cancer patients alive and helping them thrive, reported plans to initiate a Phase 2 clinical trial evaluating atebimetinib in combination with chemotherapy in patients with anaplastic thyroid cancer (ATC), a highly aggressive form of thyroid cancer with significant unmet need, commonly driven by BRAF or RAS mutations.

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Immuneering plans to submit an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for the program by the end of 2026. Subject to regulatory clearance, Immuneering currently expects to dose the first patient in the study in mid-2027, with topline results potentially available 12-18 months after dosing begins. The preliminary study plan is to enroll approximately 60 patients with ATC who progressed on standard of care, including an all-comers cohort and a BRAF V600E cohort. The study is designed to be potentially registrational, pending discussion with regulators.

ATC is one of the fastest growing and most aggressive forms of cancer. While it accounts for a small percentage of all thyroid cancers, its rapid progression and poor prognosis result in a disproportionately high share of thyroid cancer-related deaths. It is commonly driven by the MAPK pathway. BRAF mutations are the most frequently occurring alterations, and the majority of patients have tumors driven by either BRAF mutations or RAS mutations. New treatment options capable of delivering durable tumor control while maintaining tolerability are urgently needed.

"Anaplastic thyroid cancer remains one of the most challenging malignancies we encounter, with tumors that can progress extraordinarily quickly and limited treatment options for many patients," said Alan Ho, M.D., Ph.D., Chief of the Head and Neck Oncology Service at Memorial Sloan Kettering Cancer Center. "Despite important advances for certain molecularly defined subsets of patients, there remains a substantial need for new therapeutic approaches that can provide durable disease control for a broader population of patients with ATC."

"Atebimetinib has the potential to help patients with many different types of cancer, and to be synergistic in many different combinations," said Ben Zeskind, Ph.D., Co-founder and Chief Executive Officer of Immuneering. "The exciting results we have observed to date with atebimetinib in combination with chemotherapy in pancreatic cancer has reinforced our conviction in this approach. With MAPK pathway activation a defining feature of anaplastic thyroid cancer, and BRAF and RAS mutations among its key drivers, deep cyclic inhibition of MAPK signaling with atebimetinib represents an innovative, promising therapeutic approach in combination with chemotherapy for addressing the significant unmet need in anaplastic thyroid cancer. We are grateful to the esteemed group of world-class thyroid cancer experts who have helped design this study and encouraged us to pursue it with a high degree of optimism, and together we are moving full speed ahead."

The scientific rationale supporting the planned clinical program will be highlighted in a preclinical poster at the 38th EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) Symposium on Molecular Targets and Cancer Therapeutics, taking place November 18-20, 2026, in Barcelona, Spain.

Poster Presentation Details:
Title: Atebimetinib, a deep cyclic inhibitor of MEK, combined with chemotherapy: preclinical rationale for treatment of anaplastic thyroid cancer (ATC).
Abstract Number: 144
Poster Number: PB-144
Presenter: Praveen Nair
Date: Wednesday, November 18, 2026

Following presentation, the poster is expected to be available on the publications section of Immuneering’s website.

Conference Call
Immuneering will host a conference call and live webcast at 8:30 a.m. EST on November 12, 2026, to discuss today’s news announcements. Individuals interested in listening to the live conference call may do so by dialing (800) 715-9871 for U.S. callers and (646) 307-1963 for other locations and reference conference ID 6087332, or from the webcast link in the "investors" section of the company’s website at www.immuneering.com. A webcast replay will be available in the investor relations section on the company’s website for 90 days following the completion of the call.

About Anaplastic Thyroid Cancer
Anaplastic thyroid cancer, or ATC, is a rare and highly aggressive form of thyroid cancer characterized by rapid tumor growth and invasion into surrounding tissues. According to the National Cancer Institute, ATC accounts for approximately 1% to 2% of thyroid cancer cases and affects approximately one to two people per million each year in the United States. Unlike most other forms of thyroid cancer, ATC can progress extremely rapidly and frequently presents with locally advanced or metastatic disease. Standard of care chemotherapy remains a primary treatment option for ATC, however these cytotoxic agents can induce MAPK reactivation, potentially limiting response durability. Although advances in targeted therapies have improved outcomes for some patients with specific molecular alterations, there remains a substantial unmet need for new treatment approaches capable of providing durable disease control across a broader population of patients with ATC.

About Atebimetinib
Atebimetinib is the first in a new category of oral drug candidates, Deep Cyclic Inhibitors (DCIs), designed to improve overall survival by three mechanisms: shrinking tumors durably with less resistance, preserving body mass by countering cachexia, and minimizing side effects to maximize performance status and combinability. Each of these mechanisms has been well established to improve survival in published studies. DCIs challenge the conventional model of sustained or continuous inhibition in oncology. Whereas most therapies are designed for sustained inhibition, driving cancer to adapt and develop resistance so tumors shrink quickly but temporarily, DCIs are designed to pulse faster than tumors can adapt, so tumors shrink slowly but durably. Moreover, DCIs aim to restore full transient signaling to healthy cells, with the goal of leading to fewer adverse events. Atebimetinib targets MEK, a key control point in the MAPK pathway (RAS-RAF-MEK-ERK), which is pathologically activated in a majority of cancers, including approximately 97% of pancreatic cancers. Targeting MEK blocks a broader range of MAPK pathway alterations because it is further downstream, creating the potential for more durable benefit.

(Press release, Immuneering, NOV 12, 2026, View Source [SID1234674695])

Merck Delivers Solid Q3 2026 Results and Advances Strategic Priorities Across the Business

On November 12, 2026 Merck, a leading science and technology company, reported solid growth in the third quarter of 2026. Performance was driven by Process Solutions, Rare Diseases and Semiconductor Solutions, in line with the company’s focus on high growth value drivers. Group net sales increased to € 5.6 billion year-on-year (Q3 2025: € 5.3 billion), up 5.1% organically. EBITDA pre amounted to € 1.7 billion (Q3 2025: € 1.7 billion). The organic growth of 0.4% reflects a high basis of comparison in the year-earlier quarter, which benefited from several one-time effects. Merck has raised its financial guidance for the full year 2026 and now expects net sales to be between € 21.5 billion and € 21.9 billion and EBITDA pre to be between € 6.2 billion and € 6.4 billion.

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"Our third-quarter performance underscores the strength of our integrated business model with our strong position in attractive growth markets, especially biomanufacturing, discovery and development across the life sciences value chain, semiconductor manufacturing that supports AI and advanced nodes, as well as targeted specialty and rare diseases," said Kai Beckmann, Chairman of the Executive Board and Group CEO of Merck. "We delivered growth in the quarter while continuing to advance our mid- to long-term strategic agenda through innovation and sharpening our portfolio. Our upgraded full-year guidance reflects our confidence that Merck will continue to deliver solid performance in 2026."

Third-quarter results

Merck increased its Group net sales to € 5.6 billion (Q3 2025: € 5.3 billion). Organic growth of 5.1% was further supported by positive foreign exchange effects of 1.5%. At € 1.7 billion, EBITDA pre was around stable at +‍0.4% (Q3 2025: € 1.7 billion). As reported at the time, two one-time effects each had added a mid-double-digit million euro amount in the year-earlier quarter. The EBITDA pre margin was 29.9% (Q3 2025: 31.4%). Earnings per share pre amounted to € 2.32, reaching the same level as in the year-earlier quarter (Q3 2025: € 2.32).

Free cash flow increased by 22.7% year-on-year to € 1.3 billion in the third quarter (Q3 2025: € 1.1 billion). The strong cash generation supports Merck’s deleveraging: By the end of the quarter, net financial debt had declined by 10.3% since the beginning of the year.

All three business sectors increased net sales across regions and portfolios. Customer projects, capacity expansions and higher demand were the main drivers. With a share of 34.8% of net sales, Asia-Pacific grew by 12.1% and was once again the company’s largest market. Europe remained the second-largest market with a share of 29.1%, followed by North America at 24.5%.

Sharpened portfolio advances company strategy

In June 2026, Merck entered into a definitive agreement to acquire Bio-Techne Corporation, USA, for an enterprise value of approximately US$ 11.3 billion (€ 9.9 billion). Bio-Techne is a global provider of life science tools, analytical technologies and consumables. The acquisition significantly expands the Merck portfolio and strengthens the company’s ability to support customers from biological discovery to therapeutic development and manufacturing.

Merck also signed a definitive agreement to divest its contract development and manufacturing organization (CDMO) business within Life Science to Lonza. The transaction advances Merck’s mid- to long-term strategic agenda and is expected to close in mid-2027. It positions the CDMO business for its next phase of development under an organization with a dedicated focus on contract development and manufacturing.

In October 2026, Merck announced a definitive agreement to acquire Silence Therapeutics, United Kingdom. Once completed, the transaction will add divesiran to the Merck pipeline: The potentially best-in-class, phase III-ready siRNA investigational therapy is in development for phlebotomy-dependent polycythemia vera, a type of rare blood cancer. Divesiran is dosed subcutaneously once every three months. The planned acquisition is a strategically important step toward strengthening the company’s mid-stage pipeline and its focus on targeted specialty and rare diseases, one of Merck’s high growth value drivers. The transaction is expected to close in the first quarter of 2027.

Guidance for 2026

Based on the Group’s performance in the third quarter, Merck has raised its full year 2026 guidance. The company now expects net sales to be between € 21.5 billion and € 21.9 billion and EBITDA pre to be between € 6.2 billion and € 6.4 billion. This adjustment primarily reflects improvements in the underlying performance and more favorable foreign exchange effects. In addition, the guidance reflects the acquisition of Bio-Techne for the month of December 2026 as a portfolio effect in the Life Science business sector. This is an assumption; the actual closing date of the transaction may differ. The guidance further assumes no sales of Mavenclad in the United States from November 2026 (previous guidance: from August 2026) amid generic competition.

As a result, the implied organic growth corridor for Group net sales shifts to +‍3% to +‍4%. Organic EBITDA pre growth is now expected at +3% to +5%. Merck anticipates foreign exchange effects to impact net sales between –‍1% to 0%; for EBITDA pre, the range is –‍2% to 0%. This translates to an EPS pre between € 8.30 and € 8.70.

Life Science sustains growth momentum and sharpens portfolio focus

Life Science sustained strong underlying performance and positive momentum in the third quarter, supported by growth across its businesses and regions. Continued commercial execution under the go-to-market model and customer demand across key markets, especially Asia-Pacific, drove its performance. Net sales of Life Science reached € 2.4 billion, representing organic growth of 6.1% compared to the year-earlier quarter. Excluding the impact of tariff refunds to customers, organic growth was 7.3%. EBITDA pre was € 736 million, a strong organic increase of 8.7% year-on-year. The business sector increased R&D expenses and startup costs associated with new manufacturing sites, for example in Daejeon, Korea, to support future growth and advance its region-for-region strategy.

Process Solutions remained the main growth driver. The business unit, which offers solutions for every step of pharmaceutical manufacturing, delivered organic sales growth of 10.5% in line with the communicated normalizing growth rate in the second half of 2026. Demand was strong across downstream processing, single-use solutions, and upstream and processing materials. While underlying demand and customer capacity expansion remain strong, order book trends point to a softer fourth quarter.

Discovery Solutions, which supports research and early-stage discovery across biology, chemistry and analytical workflows, grew by 1.7% organically. Performance was supported by demand across the portfolio, with positive momentum in Asia-Pacific.

Advanced Solutions achieved organic sales growth of 4.3%. The business unit delivers tailored products and services that help customers address unique needs in high-touch and regulated environments. Both products and services contributed with growth across key regions.

In line with the innovation-led strategy of Merck, Life Science advanced a broad range of research and development initiatives. Recent launches include the continued advancement of MAST, a system that automatically collects samples during biopharmaceutical manufacturing: The first autosampler fully validated for use in commercial production under Good Manufacturing Practice standards. Its analytical integrations provide automated access to critical process and quality data, supporting faster, evidence-based process decisions. AI and digitalization also remained important areas of focus. Merck introduced new features for mConfig, including real-time trace element prediction that helps customers identify potential variability in cell culture media formulations before manufacturing. Merck also launched SYNTHIA Agentic AI, giving scientists natural-language access to retrosynthesis, reagent and safety information within compatible AI environments.

The proposed divestment of the CDMO business would further sharpen Life Science’s portfolio focus, allowing it to concentrate investments on technologies and capabilities that build on its scientific leadership. Life Science’s broad range of consumables, technologies and services will continue to support pharmaceutical, biotechnology and CDMO customers from discovery through manufacturing.

Healthcare continues to deliver strong performance in Rare Diseases

In Healthcare, Rare Diseases, Fertility & Endocrinology and Cardiometabolic contributed to growth amid tailwinds from foreign exchange effects. In the third quarter of 2026, net sales reached € 2.3 billion, an organic increase of 0.9% year-on-year. EBITDA pre remained stable at € 819 million. The organic decline of 3.6% was offset by positive foreign exchange effects of 3.8%.

Rare Diseases, a high growth value driver for Merck and a new strategic pillar in Healthcare, grew 41.5% organically. With organic growth of 80.4%, Gomekli/Ezmekly was the main growth driver. The treatment is approved for adults and children aged 2 years and older with neurofibromatosis type 1 who have plexiform neurofibromas. Sales of Ogsiveo, indicated for the treatment of progressing desmoid tumors, increased by 24.5% organically. Pimjetmi (pimicotinib), approved in China in December 2025 for the treatment of tenosynovial giant cell tumor (TGCT) also added to sales in the quarter.

Net sales in Cardiometabolic grew by 5.2% organically. This was mainly driven by double-digit growth of Concor, while Euthyrox and Glucophage also contributed positively.

Net sales in Fertility & Endocrinology increased by 3.6% organically. Pergoveris, indicated for the stimulation of follicular development in women with severe luteinizing hormone and follicle-stimulating hormone deficiency, grew organically by 14.1%. Sales of Gonal-f, a follicle-stimulating hormone treatment, were organically down by 2.4%. Saizen, for the treatment of various growth hormone disorders, recorded organic sales growth of 16.4%.

Specialty Care saw net sales decline by 10.2% organically. Erbitux, a treatment for metastatic colorectal cancer and for cancer of the head and neck, grew organically by 4.3%. This growth was supported by strong demand in Europe, in turn related to a recent label extension by the European Commission covering additional patient segments in colorectal cancer. Net sales of Mavenclad on the other hand declined by 25.1% organically, mainly reflecting generic competition in the United States.

In October, Merck announced new two-year follow-up data from the Phase III MANEUVER study, evaluating pimicotinib in patients with tenosynovial giant cell tumor (TGCT). The data, which was presented at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2026, showed durable tumor control and sustained improvements in TGCT symptoms and joint function with pimicotinib.

On November 10, the FDA approved Pimjetmi (pimicotinib), a once-daily oral colony stimulating factor-1 receptor (CSF-1R) inhibitor, as a systemic treatment for adults with symptomatic tenosynovial giant cell tumor (TGCT) for which surgical resection may cause worsening functional limitation or severe morbidity.

Electronics: Continued strong growth supported by AI-driven demand

The Electronics business sector delivered continued strong growth in the third quarter of 2026. This development was supported by the ongoing momentum in the semiconductor industry and was driven in particular by demand from data centers and AI-related applications. Net sales increased organically by 13.3% to € 948 million. The reported increase of 8.4% included a portfolio effect of –‍5.7% from the divestment of the Surface Solutions business unit. EBITDA pre increased by 18.4% to € 279 million, driven especially by higher volumes, favorable product mix and efficient cost management.

All businesses in Semiconductor Solutions contributed to a strong organic growth of 18.7% in the third quarter, proving the strength of a broad and enabling portfolio for advanced memory and logic applications. The results reflect the sustained growth of the semiconductor industry in 2026 and were driven by demand for advanced nodes for logic and memory chips used in AI applications. These applications require increasingly complex chip architectures with higher material content per wafer and tighter process control. Consequently, demand for the high-performance specialty materials and workflow solutions offered by Merck continues to be robust.

Organic sales in Optronics declined by 0.9%. High prices for memory chips continued to weigh on end customer demand for consumer electronics, resulting in persistent price pressure and lower demand for liquid crystals. However, positive foreign exchange effects more than offset this development.

Merck continues to invest in local markets and collaborate with key players in the industry. The company recently opened a new research and development facility for materials development, scale-up and technology transfer in Sheboygan, Wisconsin, USA, as part of a US$ 200 million multi-year investment. The facility brings materials innovation closer to customers and supports the company’s focus on AI-driven wafer processing. In Eumseong, Korea, Merck opened a new production line for molybdenum-based materials. The site combines Thin Films and Delivery Systems & Services capabilities and is expected to begin commercial production following customer qualifications in 2027.

Overview of the key figures for Q3 2026

Merck Group

Key figures

€ million

Q3 2026

Q3 2025

Change

Jan.-Sept. 2026

Jan.-Sept. 2025

Change

Net sales

5,627

5,318

5.8%

16,195

15,853

2.2%

Operating result (EBIT)1

653

1,221

-46.5%

2,343

3,118

-24.8%

Margin (% of net sales)1

11.6%

23.0%

14.5%

19.7%

EBITDA2

1,615

1,679

-3.8%

4,364

4,506

-3.1%

Margin (% of net sales)1

28.7%

31.6%

26.9%

28.4%

EBITDA pre1

1,682

1,669

0.8%

4,811

4,666

3.1%

Margin (% of net sales)1

29.9%

31.4%

29.7%

29.4%

Profit after income tax

450

898

-49.9%

1,613

2,291

-29.6%

Earnings per share (€)

1.04

2.07

-49.8%

3.68

5.26

-30.0%

Earnings per share pre (€)1

2.32

2.32

–%

6.59

6.46

2.0%

Operating cash flow

1,660

1,518

9.4%

3,083

2,641

16.8%

Sept. 30, 2026

Dec. 31, 2025

Change

Net financial debt1

7,733

8,619

-10.3%

Number of employees3

61,949

62,346

-0.6%

1 Not defined by IFRS Accounting Standards (IFRS Accounting Standards).

2 Not defined by IFRS Accounting Standards; EBITDA corresponds to operating result (EBIT) adjusted by depreciation,

amortization, impairment losses, and reversals of impairment losses.

3 This figure refers to all employees at sites of fully consolidated entities.

Merck Group

Net sales by business sector

€ million

Q3 2026

Share

Organic growth1

Exchange rate effects1

Acquisitions/ divestments1

Total change

Q3 2025

Share

Life Science

2,411

43%

6.1%

1.1%

0.4%

7.6%

2,241

42%

Healthcare

2,268

40%

0.9%

2.1%

–%

2.9%

2,203

41%

Electronics

948

17%

13.3%

0.9%

-5.7%

8.4%

875

17%

Merck Group

5,627

100%

5.1%

1.5%

-0.8%

5.8%

5,318

100%

1 Not defined by IFRS Accounting Standards.

Life Science

Net sales by business unit

€ million

Q3 2026

Share

Organic growth1

Exchange rate effects1

Acquisitions/ divestments1

Total change

Q3 20252

Share

Process Solutions

1,069

44%

10.5%

1.0%

1.1%

12.6%

949

42%

Discovery Solutions

722

30%

1.7%

1.3%

–%

3.0%

701

31%

Advanced Solutions

621

26%

4.3%

1.1%

-0.3%

5.1%

591

26%

Life Science

2,411

100%

6.1%

1.1%

0.4%

7.6%

2,241

100%

1 Not defined by IFRS Accounting Standards.

2 Prior-year figures have been adjusted to reflect the transformation of the three business units.

Healthcare

Net sales by major product lines / products

€ million

Q3 2026

Share

Organic growth1

Exchange rate effects1

Acquisitions/ divestments1

Total change

Q3 2025

Share

Rare Diseases

123

5%

41.5%

2.1%

–%

43.6%

85

4%

thereof: Ogsiveo

78

3%

24.5%

1.7%

–%

26.1%

62

3%

thereof: Gomekli

43

2%

80.4%

2.7%

–%

83.1%

23

1%

Fertility & Endocrinology

514

23%

3.6%

1.2%

–%

4.8%

490

22%

thereof: Gonal-f

175

8%

-2.4%

0.4%

–%

-2.0%

179

8%

thereof: Pergoveris

91

4%

14.1%

1.5%

–%

15.6%

79

4%

thereof: Saizen

111

5%

16.4%

1.0%

–%

17.4%

94

4%

Cardiometabolic

703

31%

5.2%

4.2%

–%

9.3%

643

29%

thereof: Glucophage

267

12%

3.0%

5.5%

–%

8.5%

247

11%

thereof: Concor

179

8%

12.2%

2.2%

–%

14.4%

156

7%

thereof: Euthyrox

188

8%

6.8%

4.6%

–%

11.4%

169

8%

Specialty Care

832

37%

-10.2%

1.1%

–%

-9.1%

916

42%

thereof: Erbitux

329

14%

4.3%

1.9%

–%

6.2%

310

14%

thereof: Bavencio

128

6%

-14.1%

-0.1%

–%

-14.2%

149

7%

thereof: Mavenclad

232

10%

-25.1%

1.1%

–%

-24.0%

305

14%

thereof: Rebif

104

5%

-12.1%

0.8%

–%

-11.3%

118

5%

Other

95

4%

–%

–%

–%

–%

68

3%

Healthcare

2,268

100%

0.9%

2.1%

–%

2.9%

2,203

100%

1 Not defined by IFRS Accounting Standards.

Electronics

Net sales by business unit

€ million

Q3 2026

Share

Organic growth1

Exchange rate effects1

Acquisitions/ divestments1

Total change

Q3 20252

Share

Semiconductor Solutions

752

79%

18.7%

0.4%

–%

19.2%

631

72%

Optronics

196

21%

-0.9%

2.5%

–%

1.6%

193

22%

Surface Solutions

–

–%

–%

–%

-100.0%

-100.0%

50

6%

Electronics

948

100%

13.3%

0.9%

-5.7%

8.4%

875

100%

1 Not defined by IFRS Accounting Standards.

2 Prior-year figures have been adjusted owing to an internal realignment.

Forecast for the Merck Group

Forecast for FY 2026

€ million

Net sales

EBITDA pre1

Free cash flow

Merck Group

~21,500 to 21,900
Organic +3% to +4%
Foreign exchange effect -1% to 0%
Portfolio ~0%

~6,200 to 6,400
Organic +3% to +5%
Foreign exchange effect -2% to 0%
Portfolio ~0%

~2,300 to 2,700

Life Science

~9,400 to 9,600
Organic +6% to +7%
Foreign exchange effect -1% to 0%
Portfolio ~+1%

~2,750 to 2,850
Organic +6% to +8%
Foreign exchange effect -2% to 0%
Portfolio ~+2%

Healthcare

~8,500 to 8,700
Organic -3% to -2%
Foreign exchange effect 0% to +1%
Portfolio +2.4% (€ 207 million)

~2,900 to 3,000
Organic -5% to -3%
Foreign exchange effect 0% to +1%
Portfolio ~0%

Electronics

~3,600
Organic +10% to +11%
Foreign exchange effect -2% to -1%
Portfolio -7.0% (€ -245 million)

~1,100
Organic +33% to +35%
Foreign exchange effect 0% to +1%
Portfolio -3.3% (€ -28 million)

Corporate and Other

~-550

1 Not defined by IFRS Accounting Standards (IFRS Accounting Standards); EBITDA corresponds to operating result (EBIT) adjusted by depreciation, amortization, impairment losses, and reversals of impairment losses.

EPS pre € 8.30 to € 8.70, based on an underlying tax rate of 22%.

(Press release, Merck KGaA, NOV 12, 2026, View Source [SID1234674694])

Vor Bio Expands Strategic Partnership with RemeGen, Adding Next Generation, Long-Acting RC298 to BAFF/APRIL Franchise

On November 12, 2026 Vor Bio (Nasdaq: VOR), a clinical-stage biotechnology company transforming the treatment of autoimmune diseases, reported an amendment to its existing agreement with RemeGen Co., Ltd (HKEX: 9995, SHA: 688331) to add RC298, a next-generation dual BAFF/APRIL inhibitor, to Vor Bio’s exclusive license for development and commercialization outside of Greater China.

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RC298 is an engineered TACI-Fc fusion protein designed to inhibit both BAFF (B cell activating factor) and APRIL (a proliferation-inducing ligand), two key regulators of pathogenic B cell and plasma cell biology. RC298 was engineered to optimize functional potency, pharmacokinetics, and developability with a structural design intended to enable sustained dual pathway inhibition and extended dosing intervals. In preclinical studies, RC298 demonstrated potent inhibition of BAFF and APRIL compared to leading BAFF/APRIL inhibitors, as well as significantly prolonged systemic exposure, supporting its potential for a differentiated, best-in-class efficacy and dosing profile.

Building on telitacicept as the clinical foundation of Vor Bio’s BAFF/APRIL franchise with three ongoing registrational trials advancing across the myasthenia gravis spectrum and Sjögren’s disease, RC298’s differentiated long-acting profile has the potential to expand the franchise into additional autoimmune diseases and treatment settings, extending the therapeutic reach of dual BAFF/APRIL inhibition.

RC298 is currently in IND-enabling development, with an IND submission in China anticipated in the first half of 2027. RemeGen will continue to lead the preclinical and Phase 1 clinical development of RC298 in China, with both companies contributing to development efforts. Following completion of the Phase 1 clinical trial, Vor Bio will assume responsibility for subsequent clinical development, regulatory activities, and commercialization of RC298 outside of greater China.

"Over the past year, our successful execution has established Vor as a leader in the BAFF/APRIL field and RC298 meaningfully strengthens that position," said Jean-Paul Kress, M.D., Chairman and Chief Executive Officer of Vor Bio. "Our conviction in building this franchise is reinforced by what FcRn therapies have already demonstrated across multiple large autoimmune diseases. We believe BAFF/APRIL can build on that precedent by acting both upstream on B cells and downstream on plasma cells, with the potential for deeper, broader, and more durable disease control."

Dr. Kress continued, "Telitacicept remains our clinical foundation and near-term priority as we execute on our global Phase 3 programs in myasthenia gravis and Sjögren’s disease. RC298 is the next step in our broader campaign to create opportunities with a long-acting, next generation molecule across new diseases and treatment settings. We are building on a biology we know deeply, alongside a partner with extraordinary clinical and commercial experience in the pathway. With multiple differentiated ways to target BAFF and APRIL, we believe Vor is best positioned to build the leading franchise in this category and deploy each molecule where its profile can create the greatest advantage for patients."

"Telitacicept is the world’s first approved innovative therapy to target both BAFF and APRIL for the treatment of a range of B cell-mediated autoimmune diseases. It has been approved in China for five indications, and its global multicenter clinical trials are progressing well. The clinical evidence to date has demonstrated the potential benefits of dual BAFF/APRIL inhibition. RC298, our next generation, long-acting dual BAFF/APRIL inhibitor, has shown best-in-class potential," said Dr. Jianmin Fang, Chief Executive Officer of RemeGen. "This transaction will broaden both companies’ global autoimmune disease portfolios and accelerate the international development of RemeGen’s innovative pipeline. With RC298, we aim to bring an innovative treatment option to patients with autoimmune diseases worldwide while strengthening RemeGen’s brand and expanding its global presence."

Transaction Terms

Under the terms of the agreement, Vor Bio will provide RemeGen with approximately $56 million in aggregate upfront consideration, consisting of a $10 million upfront cash payment and pre-funded warrants to purchase 2.3 million shares of Vor Bio common stock with an exercise price of $0.0001 per share (representing an approximate value of $46 million based on Vor Bio’s closing share price on November 11). RemeGen will be eligible to receive up to an additional $300 million in development milestone payments, including $20 million payable upon the achievement of initial clinical development and technology transfer milestones. The existing collaboration’s sales milestone and royalty framework will continue to apply on an aggregated basis across all licensed products.

About Telitacicept

Telitacicept is a novel recombinant fusion protein designed to treat autoimmune diseases through dual inhibition of BAFF (also known as BlyS) and APRIL – two cytokines essential to B cell development and plasma cell survival. By inhibiting both pathways, telitacicept has the potential to reduce autoreactive B cells and autoantibody production, targeting key drivers of autoimmune pathology.

Telitacicept is approved in China for systemic lupus erythematosus (SLE), rheumatoid arthritis (RA), generalized myasthenia gravis (gMG), IgA nephropathy (IgAN), and Sjögren’s disease (SjD).

Vor Bio is advancing global development programs across major autoimmune indications, including a global Phase 3 trial in gMG and SjD, to support potential regulatory approvals in the United States, Europe, and Japan.

(Press release, Vor BioPharma, NOV 12, 2026, View Source [SID1234674690])

Verrica Pharmaceuticals Reports Third Quarter 2026 Financial Results

On November 12, 2026 Verrica Pharmaceuticals Inc. ("Verrica" or the "Company") (Nasdaq: VRCA), a therapeutics company developing and commercializing medications for the treatment of dermatological diseases, including skin cancers, reported financial results for the third quarter ended September 30, 2026.

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"Verrica made progress in growing our commercial YCANTH business for molluscum contagiosum while advancing our late-stage pipeline for two of the most prevalent skin diseases, and extending our cash runway during the third quarter," said Jayson Rieger, PhD, MBA, President and Chief Executive Officer of Verrica. "YCANTH had another record quarter for revenue, and we are now turning our focus to maximize conversion of written to filled prescriptions and ensuring optimal insurance coverage. The efforts that began earlier this year, most notably under our YCanthRx non-dispensing pharmacy option, have matured, and during the quarter we began realizing the benefits of these efforts with improvement in gross to net."

Dr. Rieger continued, "We are also executing on our label expansion strategy for YCANTH into common warts. In August, we announced the completion of enrollment in the first pivotal trial of our global Phase 3 program in common warts after an interim analysis recommended that no additional patients were needed to power the trial. We have also enrolled more than 50% of the current patient target in the second pivotal trial, and we expect topline data from these trials in the first quarter of 2027 and mid-2027, respectively. Under our current operating plan, including finishing the global Phase 3 program in common warts, and the full utilization of our credit facility, we now have sufficient liquidity to fund operations through data readouts for both pivotal trials of the common warts program. With a prevalence of approximately 22 million patients in the U.S. alone and no FDA-approved prescription drug therapies, we believe that securing a label expansion for YCANTH into common warts could represent a multibillion-dollar commercial opportunity, if approved. Finally, we are now exploring the potential of VP-315 to treat patients with Gorlin syndrome, a rare disease that leads to dozens or hundreds of basal cell carcinomas over the patient’s lifetime, often presenting them with substantial surgical fatigue. We believe our foundational data in sporadic BCC provides promise for the potential benefit of VP-315 to Gorlin patients, and we will provide more details as the clinical protocol and anticipated timelines are finalized. We are excited about our future at Verrica, having built a solid commercial foundation to support promotion of YCANTH for molluscum which we can leverage upon any approval of YCANTH for common warts or VP-315 for BCC or Gorlin syndrome."

Conference Call and Webcast Information

The Company will host a conference call on Thursday, November 12, 2026, at 4:30 pm ET, to discuss its third quarter 2026 financial results and provide a business update. To participate in the conference call, please use the following information:

Domestic Dial-In Number: Toll-Free: 1-833-419-0865

International Dial-In Number: 1-785-838-9333

Conference ID: VERRICA

Webcast: View Source;tp_key=5f6b4ae4b1

The call will be broadcast live over the web and can also be accessed on Verrica’s website: www.verrica.com. A replay will be available for one month in the Events Calendar of the Investors section of the Company’s website.

Business Highlights and Recent Developments

YCANTH (VP-102)

•
During the third quarter, the Company recorded YCANTH net product revenue of $5.7 million, up 11.9% over the previous quarter and 57.9% year-over-year, and total revenue of $6.9 million.

•
During the third quarter, YCANTH dispensed applicator units totaled 19,135, representing a year-over-year increase of approximately 36% from the third quarter of 2025. On a sequential basis, YCANTH dispensed applicator units decreased approximately 2.5% from the prior quarter. We believe this decrease reflects summer travel seasonality, with both patients and providers.

•
On September 30, 2026, the Company announced new pooled analysis data from its two registrational Phase 3 trials of YCANTH for molluscum. These data indicated that patients treated with YCANTH achieved complete clearance at a rate approximately four times faster than patients who were treated with a placebo, and three times as many YCANTH-treated patients achieved complete clearance at each treatment visit.

•
On August 27, 2026, the Company announced completion of enrollment in the first pivotal Phase 3 trial (COVE-2) studying YCANTH for the treatment of common warts and greater than 50% enrollment in the second pivotal Phase 3 trial (COVE-3). Topline data readouts for the trials are expected in the first quarter of 2027 and mid-2027, respectively.

•
On July 21, 2026, the Company announced an exclusive distribution, marketing and supply agreement with Medomie Pharma Ltd. regarding commercial rights for YCANTH for the treatment of molluscum contagiosum in Israel. The Company is working with Medomie to support their regulatory filing in Israel.

VP-315

•
On September 10 and 30, 2026, the Company announced encore poster presentations at various scientific meetings.

•
The Company is now exploring VP-315 for the treatment of patients with Gorlin syndrome, leveraging the extensive data from the completed Phase 2 study in sporadic BCC to this patient population with high disease burden and surgical fatigue, with no current FDA-approved products available for this indication. The Company is evaluating the potential study design and associated trial budget, and will update its business plan upon finalizing any study of VP-315 for the treatment of Gorlin syndrome

Corporate

•
On October 22, 2026, the Company announced achievement of milestones unlocking access to the remaining $15.0 million of non-dilutive growth capital under its $27.5 million credit facility with an entity controlled by Paul B. Manning, the Company’s Chairman and largest shareholder. With this additional borrowing capacity, based on the Company’s current business plan, the Company believes that its cash runway will extend into the fourth quarter of 2027, without giving effect to any potential clinical trial costs related to the study of VP-315 for the treatment of Gorlin syndrome.

Financial Results

Third Quarter 2026 Financial Results

•
Total revenue for the three months ended September 30, 2026, was $6.9 million compared to total revenue of $14.3 million for the three months ended September 30, 2025, which included a $10.0 million one-time milestone payment from Torii Pharmaceutical Co., Ltd., Verrica’s Japanese development partner.

•
U.S. YCANTH product revenue, net was $5.7 million for the quarter ended September 30, 2026, compared to net product revenue of $3.6 million for the quarter ended September 30, 2025. The increase in product revenue, net, was primarily related to increased deliveries of YCANTH to our distribution partners as well as improved yield from reduced spending on our co-pay assistance program.

•
License and collaboration revenue was $1.2 million for the quarter ended September 30, 2026, consisting primarily of commercial supply for Torii’s YCANTH launch in Japan, compared to license and collaboration revenue from Torii of $10.7 million for the three months ended September 30, 2025, which included $10.0 million of one-time milestone revenue, as well as $0.7 million of collaboration revenue for supplies and development activity with Torii.

•
Costs of product revenue were $0.6 million for the quarter ended September 30, 2026, compared to $0.8 million for the quarter ended September 30, 2025, consisting primarily of product costs related to the sale of YCANTH.

•
Selling, general and administrative expenses were $10.4 million for the quarter ended September 30, 2026, compared to $9.4 million for the same period in 2025. Excluding the impact of stock-based compensation, expenses were comparable to the prior period.

•
Research and development expenses were $7.6 million for the quarter ended September 30, 2026, compared to $2.2 million for the same period in 2025. Excluding the impact of stock-based compensation, the increase of $5.2 million was primarily attributable to an increase of $3.7 million in non-cash costs associated with the Phase 3 program for common warts, in addition to an increase of $1.3 million in expenses related to chemistry, manufacturing and controls across YCANTH and VP-315. The expense for the Phase 3 common warts program did not impact Verrica’s cash balance, as the first $40 million of payments for this program, representing approximately 90% of the current estimated study costs, will be made by Torii under the Company’s collaboration and license agreement.

•
Interest income was $45,000 for the quarter ended September 30, 2026, compared to $0.2 million for the quarter ended September 30, 2025. The decrease in interest income was primarily due to lower cash balances.

•
Interest expense was $0.3 million for the quarter ended September 30, 2026, compared to $2.1 million for the same period in 2025. The decrease of $1.8 million was related to the settlement and termination of the Company’s OrbiMed debt facility in November 2025, partially offset by imputed interest on the R&D funding liability and $0.1 million of interest expense on term loans borrowed under the Company’s new credit facility with an affiliate of Paul B. Manning, the Company’s Chairman and largest shareholder

•
For the quarter ended September 30, 2026, net loss was $12.4 million, or $0.58 per share, compared to a net loss of $0.3 million, or $0.03 per share, for the same period in 2025.

•
For the quarter ended September 30, 2026, non-GAAP net loss was $10.5 million, or $0.49 per share, compared to a non-GAAP net income of $1.1 million, or $0.12 per share, for the same period in 2025.

(Press release, Verrica Pharmaceuticals, NOV 12, 2026, View Source [SID1234674689])