On November 5, 2026 FORE Biotherapeutics reported that the Company will participate at the following investor conferences:

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Stifel 2026 Healthcare Conference. The Company will attend on Thursday, November 12, and will provide a corporate presentation at 9:20 a.m. – 9:50 a.m. ET.
Jefferies 2026 Global Healthcare Conference in London. The Company will attend and participate in one-on-one meetings from Monday, November 16 – Wednesday, November 18.

Management will host and participate in one-on-one meetings. Please contact Argot Partners to schedule one-on-one meetings with the management team.

(Press release, Fore Biotherapeutics, NOV 5, 2026, View Source [SID1234674307])

On November 5, 2026 Fate Therapeutics, Inc. (NASDAQ: FATE), a clinical-stage biopharmaceutical company dedicated to bringing a transformative and broadly accessible pipeline of induced pluripotent stem cell (iPSC)-derived cellular immunotherapies to patients with cancer and autoimmune disease, reported financial results and a business update for the third quarter ended September 30, 2026.

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"The third quarter was defined by steady execution across our portfolio, bringing us closer to our goal of delivering off-the-shelf, master cell bank derived cell therapies to the patients who need them most," said Bob Valamehr, Ph.D., MBA, President and Chief Executive Officer of Fate Therapeutics. "Momentum continues to build for RECLAIM-LN, and the updated Phase 1 data presented at ASN Kidney Week further supports the Phase 2 study design, including updated safety and efficacy data that reinforces the unique and encouraging product profile of FT819 in lupus. We are also excited to roll out the Phase 1/2 COMPLETE trial, with the recently cleared IND application for FT839, our first-of-kind, dual CAR T-cell co-targeting CD19 and CD38 for the comprehensive elimination of complex autoimmune disorders. At the upcoming ACR Convergence, our four presentations across FT819 and FT839 will give the rheumatology community an additional look at our clinical programs in autoimmune disease. Our progress this year, together with continued extension of our cash runway, positions us well for important milestones ahead, and we remain focused on execution as we work to deliver across multiple fronts in 2027."

Clinical Development & Program Updates

RECLAIM-LN, FT819 Phase 2 potentially registrational trial in lupus nephritis

The Company continues to advance RECLAIM-LN, a Phase 2 potentially registrational trial of FT819 in lupus nephritis (LN), with enrollment currently open across 17 active sites. In August, the study was initiated and the first patient was treated in an outpatient setting. New Phase 1 efficacy and safety data presented at American Society of Nephrology (ASN) further supports the design and advancement of RECLAIM-LN.

The RECLAIM-LN trial is an open-label, single-arm study developed following interactions with the FDA under the Company’s Regenerative Medicine Advanced Therapy (RMAT) designation. The Phase 2 potentially registrational clinical trial is expected to enroll approximately 53 patients. Patients will receive a single dose of FT819 administered at 900 million cells following bendamustine conditioning, with complete renal response (CRR) at Week 26 as the primary endpoint. The conditioning regimen selected for RECLAIM-LN is fludarabine-free and less-intensive than other CAR T-cell clinical trials, which typically incorporate up to three days of co-administration of cyclophosphamide and fludarabine, a combination that was observed as less desirable to patients and clinicians, in part because of the potential increase in serious adverse events.

Encouraging safety data demonstrated across all 29 autoimmune patients treated with a single dose of FT819 and less-intensive fludarabine-free conditioning as of a data cutoff date of August 18, 2026

•
No dose-limiting toxicities and no immune effector cell-associated neurotoxicity syndrome (ICANS), no graft-versus-host disease (GvHD), no immune effector cell-associated hemophagocytic lymphohistiocytosis-like syndrome (IEC-HS), and no deaths were reported.
•
No cytokine release syndrome (CRS) above Grade 2 was observed; Grade 1–2 CRS occurred in 5 patients (17.2%).
•
Grade ≥3 infections occurred in 2 patients (6.9%), both urinary tract infections, and Grade ≥3 cytopenias occurred in 6 patients (20.7%).
The Company believes this encouraging safety profile reflects the distinct molecular design and manufacturing features of FT819, including a tuned CAR motif with targeted insertion into the TRAC locus designed to prevent uncontrolled T-cell expansion, and a well-vetted clonal master iPSC bank that serves as a consistent and uniform starting point for manufacture of drug product for broad patient availability. Additionally, the use of a less-intensive, fludarabine-free conditioning approach is intended to significantly reduce the possibility for adverse events, and the avoidance of fludarabine, which is cleared by the kidneys and requires dose adjustment in patients with impaired renal function, is particularly relevant for patients with LN.

Updated Phase 1 lupus nephritis data presented at ASN Kidney Week 2026 supports RECLAIM-LN

In October, updated Phase 1 data from the ongoing FT819-102 study were featured in an oral presentation at the ASN Kidney Week 2026 by Jonathan D. Graf, MD, of the University of California, San Francisco. In the cohort of patients with active LN treated with FT819 and bendamustine conditioning, the regimen selected for RECLAIM-LN, patients with Month 6 follow-up (n=2) achieved a CRR or primary efficacy renal response (PERR), and mean urine protein-to-creatinine ratio (UPCr) decreased by approximately 50% from baseline. Notably, the clinical efficacy results were in conjunction with discontinuation of immunosuppressant medications prior to study intervention (low dose prednisone and hydroxychloroquine were permitted). The CRR was sustained through Month 24 in the single patient to reach that timepoint. These renal responses were accompanied by reductions in lupus disease activity, improvement in patient-reported fatigue, and strong evidence of B-cell rebalancing which is believed to be important for achieving long-term treatment durability.

Encore FT819 clinical data presented at CCR – West 2026

In September, the Company presented encore clinical data from the systemic lupus erythematosus (SLE) arm of its Phase 1 FT819-102 trial at the Congress of Clinical Rheumatology West (CCR – West) meeting in Huntington Beach, CA. The presentation included 16 SLE patients treated with a single dose of FT819 and less-intensive, fludarabine-free conditioning (Regimen A, either single-dose cyclophosphamide or two doses bendamustine), 13 of whom had at least one month of follow-up as of the May 14, 2026, data cutoff. Improvements in SLEDAI and FACIT-Fatigue scores were observed early after treatment and maintained over time. Importantly, in patients with active LN at baseline, Month 6 UPCr decreased by 1.15 g/g across Regimen A and by 1.8 g/g in the subset of patients treated with FT819 and bendamustine, demonstrating improvement in kidney function.

FT819 in systemic sclerosis (SSc) and extra renal SLE

Beyond lupus nephritis, the Company continues to advance FT819 in its ongoing Phase 1 autoimmune basket trial, including in SSc and extrarenal SLE. In July, the Company presented preliminary clinical data from the SSc arm of the trial at the International Society for Stem Cell Research (ISSCR) 2026 Annual Meeting. As of the June 12, 2026, data cutoff, all four treatment-refractory SSc patients treated with FT819 achieved a Revised Composite Response Index in Systemic Sclerosis (rCRISS) of 25 or higher, along with meaningful improvement in Modified Rodnan Skin Score (mRSS), at three months post-treatment. Three patients received less-intensive conditioning chemotherapy (cyclophosphamide or bendamustine alone) and one received no conditioning chemotherapy. The Company will present new data on extrarenal SLE at the upcoming ACR Convergence.

Four upcoming presentations at ACR Convergence 2026

The Company is looking forward to ACR Convergence 2026, being held November 6–11 in Orlando, Florida, where four abstracts from its off-the-shelf CAR T-cell programs have been selected for presentations. Two FT819 presentations will feature updated clinical data, including administration of FT819 without conditioning chemotherapy, a biomarker association with improvement in fatigue, and continued progress in outpatient administration to expand access to community-based care. A third presentation, conducted in collaboration with the Lupus Foundation of America, reports findings from a focus group of patient preferences for off-the-shelf, allogeneic CAR T-cell therapy in lupus. A fourth presentation will provide an update on FT839 preclinical studies and the design and progress of COMPLETE, its Phase 1/2 basket trial in autoimmune disease, including comprehensive targeting of activated immune cells in rheumatoid arthritis.

FT839: Next-generation off-the-shelf dual-CAR T-cell product candidate co-targeting CD19 and CD38

In July, the FDA cleared the Company’s IND application for FT839. COMPLETE (FT839-101) is a single-arm, open-label Phase 1/2 basket trial designed to evaluate FT839 across multiple autoimmune indications in combination with background therapy without the requirement for conditioning chemotherapy, with a starting dose level of 900 million cells. The Phase 1/2 design is intended to enable simultaneous assessment of safety and efficacy in a single trial to shorten the transition from Phase 1 to Phase 2. The Company has now activated multiple clinical sites, reflecting strong investigator interest, and expects to dose patients by year-end, including in rheumatoid arthritis.

FT839 has been engineered with 13 targeted genetic edits that together are intended to confer multi-antigen targeting, immune evasion, and enhanced functional persistence without the requirement for intensive conditioning chemotherapy. FT839 is designed to broaden the reach of off-the-shelf CAR T-cell therapy beyond B-cell depletion by simultaneously targeting CD19 and CD38. The elimination of B-lineage cells, including plasma cells, and CD38-expressing activated and proliferating immune cells (e.g., T cells, macrophages and NK cells) is expected to support comprehensive immune reset across a diverse spectrum of autoimmune conditions.

To support the Phase 1/2 COMPLETE clinical trial, the Company has completed the FT839 manufacturing campaign resulting in a uniform CAR T-cell product. Analogous to master cell banks used to mass produce biopharmaceutical drug products such as monoclonal antibodies, a precisely engineered clonal master iPSC bank, consisting of the 13 edits, serves as the starting cell source to uniformly manufacture FT839, overcoming numerous limitations associated with patient and donor-sourced CAR T-cell therapies. FT839 is well-defined, consistent and uniform in composition, produced at a low cost of goods, and can be stored in inventory for off-the-shelf, on-demand availability to enable access for a broad patient population.

FT836: Next-generation off-the-shelf CAR T-cell product candidate targeting MICA/B

Enrollment in the Phase 1 solid tumor basket study is continuing, including metastatic colorectal cancer (mCRC) and non-small cell lung cancer (NSCLC). FT836 is currently being studied in combination with existing standard-of-care therapies, or with conditioning chemotherapy. The study continues to build preliminary evidence of anti-tumor activity, with meaningful target lesion reductions in heavily pre-treated patients. The investigator-initiated trial of FT836 with daratumumab in multiple myeloma is also ongoing.

Other Corporate Updates

$15.0 million CIRM CLIN2 grant awarded to support RECLAIM-LN.

The California Institute for Regenerative Medicine (CIRM) awarded the Company a $15.0 million grant through its CLIN2 program to support the clinical development of RECLAIM-LN. CLIN2 is a competitive program that funds clinical-stage candidates with the potential to become transformative therapies while addressing barriers to patient access. The award builds on CIRM’s prior CLIN2 support of the FT819 Phase 1 study and recognizes the potential of an on-demand, off-the-shelf CAR T-cell therapy to broaden access for patients with refractory lupus.

Expansion of executive leadership team with newly created commercial position

The Company appointed Jamie Harrell to its executive leadership team in a newly created role leading commercial and market development strategy across its autoimmunity and oncology programs. Mr. Harrell brings more than 25 years of commercial leadership experience, most recently as Vice President of Marketing and Commercial Operations at Aurinia Pharmaceuticals, where he accelerated the growth of the first oral therapy for lupus nephritis.

Third Quarter 2026 Financial Results

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Cash & Investment Position: Cash, cash equivalents, and investments as of September 30, 2026, were $139.1 million, a quarterly decrease of $14.7 million. Cash position does not include cash from the recently awarded CIRM grant of $15.0 million.
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Total Operating Expenses: Total operating expenses were $32.2 million for the third quarter of 2026, including research and development expenses of $24.2 million and general and administrative expenses of $8.0 million.
•
Year-to-Date Operating Expense Reduction: Total operating expenses for the nine months ended September 30, 2026, decreased by $18.5 million compared to the same period in 2025, reflecting a $9.1 million, 11% reduction in research and development expenses and a $9.4 million, 26% reduction in general and administrative expenses.
•
Net Loss:Net loss was $30.7 million, or $(0.25) per share, for the third quarter of 2026, compared to $32.3 million, or $(0.27) per share, for the third quarter of 2025.
•
Shares Outstanding: As of September 30, 2026, common shares outstanding were 121.5 million, pre-funded warrants outstanding were 3.9 million, and preferred shares outstanding were 2.8 million. Each preferred share is convertible into five common shares.
Financial Guidance

•
Cash, cash equivalents, and investments of $139.1 million, along with the newly awarded $15.0 million CIRM grant, extends the cash runway to mid-2028.
About FT819

FT819 is an off-the-shelf CD19-targeting chimeric antigen receptor (CAR) T-cell product candidate engineered to improve safety and efficacy. Analogous to master cell banks used to mass produce biopharmaceutical drug products such as monoclonal antibodies, a precisely engineered clonal master induced pluripotent stem cell (iPSC) bank serves as the starting cell source to manufacture FT819, overcoming numerous limitations associated with patient- and donor-sourced CAR T-cell therapies. FT819 is well-defined and uniform in composition, produced at a low cost of goods, and can be stored in inventory for off-the-shelf, on-demand availability to enable access for a broad patient population. This research was additionally made possible by funding from the California Institute for Regenerative Medicine (CIRM), a state agency in California that supports research in regenerative medicine, stem cell therapy, gene therapy, and clinical trials. (Grant numbers: CLIN2-16303 and CLIN2-20291)

About FT839

FT839 is the Company’s first multi-antigen dual-CAR T-cell product candidate, designed to express two unique CARs: a first CAR targeting the B-cell lineage marker CD19 and a second CAR targeting the immune activation marker CD38, which is often found on aberrant T, NK and B cells. FT839 is a 13-point edited CAR T cell and the second program to incorporate the Company’s Sword & Shield technology. The FDA cleared the IND application for FT839 in July 2026, and the Company is conducting COMPLETE (FT839-101), a Phase 1/2 basket clinical trial evaluating FT839 across autoimmune indications in combination with standard-of-care therapy, without the requirement for conditioning chemotherapy.

About FT836

FT836 is the Company’s multipoint-edited CAR T-cell product candidate uniquely targeting major histocompatibility complex class I chain-related proteins A (MICA) and B (MICB). The expression of MICA/B cell-surface proteins is induced by cellular stress or malignant transformation and is detectable across many types of cancer cells with limited expression on healthy tissue. FT836 is the Company’s first product candidate to incorporate the novel Sword & Shield technology, which utilizes the Company’s novel alloimmune defense receptor (ADR) alongside CD58 knockout, to both target and evade host alloreactive immune cells for a comprehensive strategy to avoid the need for conditioning chemotherapy. In January 2025, the Company secured a $4 million award from CIRM to support IND-enabling activities for FT836.

(Press release, Fate Therapeutics, NOV 5, 2026, View Source [SID1234674306])

On November 5, 2026 Evotec SE (NASDAQ: EVO; Frankfurt Prime Standard: EVT) reported financial results for the third quarter and first nine months of 2026, provided an update on the implementation of its Horizon transformation and outlined its strategic and financial ambition for 2030.

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Dr. Christian Wojczewski, Chief Executive Officer of Evotec, said:

"During the third quarter and first nine months of 2026, we made encouraging progress across several areas that are important to Evotec’s future development. Commercial momentum remained solid, Horizon is delivering ahead of plan and Just – Evotec Biologics is advancing toward commercial-scale manufacturing. Implementation of our strategy is gaining momentum and is increasingly reflected in our performance. Group revenue reached €164.9 million in the third quarter, well above the first two quarters of the year, supported by a robust contribution from the D&PD base business.

We also successfully launched several new partnerships based on our technology platforms. Recent examples include Plectonic, where we are exploring new T-cell-engaging approaches in solid tumors. With Odyssey Therapeutics, our AI-enabled discovery platform is supporting drug discovery in autoimmune and inflammatory diseases. These collaborations illustrate how we are applying our differentiated scientific capabilities in new areas, creating exciting opportunities with partners."

Selected Business Highlights

Evotec made strong progress across its differentiated platforms and strategic partnerships:

Just – Evotec Biologics (JEB)

Vertex Pharmaceuticals – Commercial Manufacturing of Povetacicept: Evotec confirms that Just – Evotec Biologics has been selected by Vertex Pharmaceuticals for commercial manufacturing of povetacicept at its J.POD Redmond facility. The agreement marks an important step in the evolution of JEB’s continuous manufacturing platform toward commercial readiness. Evotec is highly confident in its ability to fulfill its commercial manufacturing and supply commitments to Vertex.
DoW Orthopoxvirus Program – JST-018 Phase 1 Initiated: In September 2026, Evotec announced the initiation of a Phase 1 clinical trial evaluating JST-018, an investigational antibody cocktail developed by Just – Evotec Biologics under the U.S. Department of War’s Accelerated Antibodies Program. Just – Evotec Biologics advanced the program from antibody sequence selection through preclinical development, process development, regulatory submission and cGMP manufacture of clinical trial materials.
Discovery and Preclinical Development (D&PD)

Jazz Pharmaceuticals – Phase 1 Initiated: Jazz Pharmaceuticals has initiated a Phase 1 clinical trial of a candidate for the potential treatment of narcolepsy and idiopathic hypersomnia. The candidate was discovered through Jazz’s sleep disorders collaboration with Evotec. Evotec combined its proprietary virtual screening and generative AI platforms with rational design to identify novel leads, subsequently optimized with the aid of cryoEM and molecular dynamics simulations. Evotec is eligible to milestone payments.
Plectonic Research Collaboration – Novel Immunotherapy Approaches: In September 2026, Evotec and Plectonic entered a research collaboration combining Evotec’s BiTco platform with Plectonic’s LOGIBODY technology to explore new T-cell-engaging approaches for solid tumors. The collaboration will generate preclinical proof-of-concept data to evaluate whether the combined technologies can improve the precision and potency of these approaches.
Odyssey Therapeutics Research Collaboration – AI-Enabled Drug Discovery: In August 2026, Evotec entered an R&D collaboration combining Odyssey’s expertise in autoimmune and inflammatory diseases with Evotec’s AI-enabled discovery platform, advanced screening capabilities and proprietary compound libraries. Evotec is eligible to receive milestone payments based on the successful delivery of validated starting points for drug discovery across multiple targets.
Commercial Execution

Commercial momentum and execution continued to strengthen during the third quarter of 2026. Net sales in the D&PD base business, comprising stand alone services and integrated programs, increased by 24% year-on-year in the first nine months. Positive trends extended across the commercial funnel, with growth in the customer base, higher proposal activity and faster proposal turnaround. The strategic partnership opportunity pipeline also continued to expand.

Horizon Transformation

Horizon is progressing ahead of plan, with structural measures translating into measurable financial and operational improvements. By the end of September, Evotec had delivered more than 20% of the €75 million in annual run-rate savings targeted by the end of 2027, already within the 20-30% contribution planned for full-year 2026. Approximately half of the planned workforce reductions have been implemented. Footprint consolidation is advancing, with three of the four site closures expected to be completed by year-end and the fourth in the first quarter of 2027. Alongside these measures, Evotec is concentrating scientific capabilities in focused Centers of Excellence and strengthening commercial execution to build a more efficient operating model and support sustainable profitability. Evotec expects to deliver the transformation program in full and on schedule by the end of 2027.

Leadership Update

Chief Scientific Officer: Dr. Joanna Holbrook

As announced on October 15, 2026, Dr. Joanna Holbrook has succeeded Dr. Cord Dohrmann as Chief Scientific Officer and member of Evotec’s Management Board, effective November 1, 2026.

Bringing more than 25 years of experience as a scientist and R&D leader, Dr. Holbrook will lead Evotec’s global scientific strategy, with a focus on strengthening scientific differentiation across discovery and development services, technology platforms and proprietary innovation. Her expertise across data, AI and novel technologies will support Evotec in building integrated solutions to important challenges in drug discovery and helping customers and partners discover and develop new medicines faster and with a greater probability of success.

2030 Mid-Range Framework – Building a Structurally Stronger Business

Evotec is building a more balanced and profitable business, drawing on the distinctive strengths of its component parts. The 2030 framework calls for around €1 billion in Group revenue by 2030, with potential for additional upside. It includes an adjusted EBITDA margin of 20% by the end of 2028, rising above 20% by the end of 2030.

The D&PD base business, comprising standalone services and integrated programs, is expected to contribute approximately 40% of Group revenue in 2030. Growth is expected to be supported by continued market recovery, commercial investments and Evotec’s differentiated service offerings.

D&PD strategic partnerships and innovation-related activities are expected to contribute approximately 20% at above-average margins. This contribution incorporates risk-adjusted assumptions regarding program progression and associated revenue, while future royalty income is not included. Performance exceeding these assumptions could provide additional revenue upside beyond the approximately €1 billion framework.

Just – Evotec Biologics is expected to contribute approximately 40% of Group revenue as the business scales, supported by capacity expansion, licensing income and future, contractually agreed royalties.

Profitability is expected to benefit from greater contribution from scalable, higher-margin activities, operating leverage and continued cost efficiency.

Financial Results

Claire Hinshelwood, Chief Financial Officer of Evotec, said:

"Our strong third-quarter performance reflects the positive impact of the commercial investments and Horizon initiatives launched earlier this year. We are now seeing these efforts translate into improved profitability and operational momentum. Looking ahead, our focus remains on converting this momentum into sustainable revenue growth and stronger cash generation, while maintaining disciplined cost management, liquidity oversight, and capital allocation. Today, we are pleased to provide greater transparency into our 2030 financial framework, including the business mix and operational drivers that support a high-quality, diversified platform for future earnings growth."

Group Financials

For the third quarter of 2026, Group revenue amounted to €164.9 million
(€164.2 million CER), essentially unchanged from €163.9 million in the prior-year quarter. Adjusted Group EBITDA was -€1.6 million (-€1.7 million CER), versus
-€15.0 million in the same prior‑year period, reflecting a marked year-on-year improvement of 89.1% primarily attributable to lower cost of revenue.

For the nine months ended September 30, 2026, Group revenue amounted to €465.0 million (€477.4 million CER), compared with €535.1 million in the prior-year period, reflecting a 13.1% decline. Consistent with the Company’s focus on cost discipline, R&D expenses amounted to €29.7 million or 6.4% of total Group revenue, compared with €42.3 million or 7.9% of total Group revenue in the prior-year period. Adjusted Group EBITDA decreased to -€44.3 million (-€39.1 million CER), down from -€16.9 million for the nine months ending September 30, 2025. The decrease in revenue was partially offset by lower cost of revenue.

Evotec closed the third quarter of 2026 with a liquidity position of €400.9 million, reflecting a net debt position.

Segment Financials (excluding intersegment revenue)

Discovery and Preclinical Development (D&PD)

For the third quarter of 2026, revenue for Discovery & Preclinical Development totaled €120.1 million (€119.6 million CER), representing a modest year-on-year decline of 2.3%. Adjusted EBITDA for the quarter improved to -€1.0 million
(-€1.4 million CER), compared with -€9.5 million in the third quarter of 2025.

For the first nine months of 2026, revenue totaled €348.0 million (€355.5 million CER), compared with €391.9 million in the prior-year period. The 11.2% year-on-year decrease was primarily driven by lower sales-to-revenue conversion across all D&PD segments. Adjusted EBITDA for the segment was -€25.5 million
(-€19.8 million CER), compared with -€18.8 million in the prior-year period. The decrease was primarily driven by lower revenue and partially offset by a lower cost base across cost of revenue, R&D and SG&A.

Just – Evotec Biologics (JEB)

Third quarter 2026 revenue at Just – Evotec Biologics totaled
€44.8 million (€44.6 million CER), representing a 9.4% increase compared with the prior-year period. Adjusted EBITDA reached -€0.6 million (-€0.3 million CER), compared with -€5.5 million in the prior-year period.

For the first nine months of 2026, revenue totaled €117.1 million (€121.9 million CER), compared with €143.2 million in the same period in 2025. The 18.3% year-on-year decrease was primarily driven by the $25 million Sandoz license sale recognized in Q1 2025 and delayed program activities. Adjusted EBITDA amounted to -€18.8 million (-€19.3 million CER), compared with an Adjusted EBITDA of €1.9 million in the prior-year period.

Reaffirming Full-Year 2026 Guidance

Evotec confirms its full-year 2026 outlook for Group revenue of approximately €570 to €610 million (€595 to €635 million CER) and adjusted Group EBITDA of approximately -€105 to -€70 million (-€90 to -€60 million CER).

Strategic Review

The strategic evaluation announced in connection with the Company’s first quarter 2026 results on May 6, 2026, remains ongoing and continues alongside the implementation of the Horizon transformation program. Additional details regarding the review are available in the Company’s Q1 2026 results announcement.

Webcast Details

Evotec will host a webcast and conference call today at 2 p.m. CET / 1 p.m. GMT / 8 a.m. EST.

To join the audio webcast and to access the presentation slides, please register via this link.

The on-demand replay of the webcast will be available under the same link after the event and on our website.

Conference Call Details

To join the conference call, please pre-register via this link. You will receive a confirmation email with dedicated dial-in details such as telephone number, access code and PIN to access the call.

A simultaneous slide presentation for participants dialing in via phone is available under this link.

(Press release, Evotec, NOV 5, 2026, View Source [SID1234674305])

On November 5, 2026 Lantheus Holdings, Inc. (Lantheus or the Company) (NASDAQ: LNTH), the leading radiopharmaceutical-focused company committed to enabling clinicians to Find, Fight and Follow disease to deliver better patient outcomes, reported financial results for its third quarter ended September 30, 2026.

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In addition, and as previously announced, Lantheus entered into a definitive agreement on August 3, 2026 to merge with Curium under which Curium US Holdings LLC will acquire all outstanding shares of Lantheus for $102.50 per share in cash at closing, plus non-transferable Contingent Value Rights ("CVRs") providing for up to $12.00 per share in potential additional cash payments, subject to achievement of specified commercial milestones for Lantheus’ products through 2030. The transaction represents a total per share consideration of up to $114.50 and a total transaction value of up to approximately $8.0 billion. Together, Curium and Lantheus are positioned to create a radiopharmaceutical company spanning diagnostics and therapeutics, with the infrastructure and capabilities to serve patients in more than 70 countries. The Board of Directors of Lantheus has unanimously approved the transaction. Additional information regarding the transaction is available in the Company’s Current Report on Form 8-K filed with the SEC on August 4, 2026.

In connection with the pending transaction, Lantheus is suspending its previously issued full year 2026 financial guidance and will not be hosting a conference call in connection with its third quarter 2026 results.

Summary Financial Results

Three Months Ended
September 30,
(in millions, except per share data – unaudited) 2026 2025 % Change
Worldwide revenue $ 389.9 $ 384.0 1.5 %
GAAP net income $ 22.4 $ 27.8 (19.4 %)
GAAP fully diluted earnings per share $ 0.33 $ 0.41 (19.5 %)
Adjusted net income (non-GAAP) $ 115.1 $ 85.7 34.3 %
Adjusted fully diluted earnings per share (non-GAAP) $ 1.68 $ 1.27 32.3 %

Third Quarter 2026

Worldwide revenue increased 1.5% to $389.9 million compared to the same period in 2025.
Sales of PYLARIFY were $238.9 million, a decrease of 0.7%.
Sales of Neuraceq were $45.6 million, an increase of 123.0%.
Sales of DEFINITY were $85.7 million, an increase of 4.8%.
Operating income decreased 26.2% to $32.2 million. Adjusted operating income (non-GAAP) increased 28.1% to $153.2 million.
Fully diluted earnings per share decreased 19.5% to $0.33, compared to fully diluted earnings per share of $0.41 in the prior year period. Adjusted fully diluted earnings per share (non-GAAP) increased 32.3% to $1.68, compared to $1.27 in the prior year period.
Net cash provided by operating activities and free cash flow were $102.0 million and $99.9 million, respectively.

Balance Sheet

At September 30, 2026, the Company’s cash and cash equivalents were $683.6 million, compared to $359.1 million at December 31, 2025.
The Company currently has access to up to $750.0 million from a revolving line of credit.

Recent Business Highlights

Received CMS Transitional Pass-Through payment status and a permanent HCPCS code, each effective October 1, 2026, for PYLARIFY TruVu (piflufolastat F18), supporting the Company’s previously announced phased geographic commercial launch.
Received FDA approval for TAUKLARIFY (florquinitau F-18 injection), an F-18-labeled tau PET imaging agent for the evaluation of adults with cognitive impairment being assessed for Alzheimer’s disease. The Company intends to continue supporting Alzheimer’s disease therapeutic programs through its Pharma Solutions business while assessing the appropriate path toward broader commercial availability.
Received final FDA approval for BRAVNETSA (lutetium Lu 177 dotatate), the only radiopharmaceutical the FDA has determined to be bioequivalent and therapeutically equivalent to LUTATHERA for the treatment of adults with somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors; the Company is preparing for a thoughtful commercial launch to support reliable supply and broad patient access.
Dosed the first patient in the SPARROW study, a Phase 2/3 registrational trial evaluating LNTH-2401, the Company’s investigational GRPR-targeted PET imaging agent for prostate cancer; the Phase 3 portion is expected to enroll approximately 400 participants and evaluate diagnostic performance, safety and tolerability.

(Press release, Curium Pharma, NOV 5, 2026, View Source [SID1234674304])

On November 5, 2026 Corvus Pharmaceuticals, Inc. (Nasdaq: CRVS), a clinical-stage biopharmaceutical company, reported a business update and announced financial results for the third quarter ended September 30, 2026.

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"We continue to drive the science and advance the breadth of potential clinical indications for ITK inhibition with soquelitinib," said Richard A. Miller, M.D., co-founder, president and chief executive officer of Corvus. "Our Phase 3 PTCL and Phase 2 atopic dermatitis clinical trials are on track and there has been strong interest in our new hidradenitis suppurativa trial. We also are making good progress towards initiating a unique asthma trial that will include both T2 and non-T2 patients by Q1 2027. We believe soquelitinib has the potential to be effective in both types of asthma patients based on its mechanism of action affecting Th2, Th17 and T regulatory cells, which we will be closely analyzing in our hidradenitis suppurativa trial. Taken altogether, we are positioned for a series of potentially significant data milestones across our soquelitinib development pipeline in 2027."

Business Update and Strategy

Soquelitinib for Immune Diseases

Corvus is enrolling patients in the SIERRA1 Phase 2 randomized, blinded, placebo-controlled atopic dermatitis clinical trial. The trial is anticipated to enroll approximately 200 patients with moderate-to-severe atopic dermatitis that have failed at least one prior topical or systemic therapy. This includes four cohorts of 50 patients each, with soquelitinib doses of 200 mg once per day, 200 mg twice per day and 400 mg once per day, along with a placebo group. The treatment period is 12 weeks with a 90-day follow-up period with no treatment. The primary endpoint of the trial is the percent change from baseline in Eczema Area and Severity Index (EASI) score at Week 12 compared to placebo.
Angel Pharmaceuticals (Angel Pharma), Corvus’ partner in China, is enrolling a Phase 1b/2 clinical trial evaluating soquelitinib in patients with moderate-to-severe atopic dermatitis. This is a blinded, placebo-controlled trial that is planned to evaluate a 12-week treatment regimen in 48 patients utilizing soquelitinib doses of 100 mg twice per day, 200 mg once per day, 200 mg twice per day and 400 mg once per day. The patient eligibility and endpoints are similar to those used previously by Corvus. Depending on the results from the Phase 1b portion of the study, an additional 60-90 patients will be enrolled in the Phase 2 portion of the study. The trial is open at several leading dermatology centers in China who have been involved in global registration trials. The study is conducted in close collaboration with Corvus. Angel Pharma completed enrollment in cohort 1 (n=24, 100 mg twice per day, 200 mg once per day and placebo) of the Phase 1b portion of the trial and results from this cohort are anticipated in March 2027. The baseline characteristics of the 24 patients enrolled in cohort 1 are similar to the baseline characteristics of the 72 patients in Corvus’ Phase 1 atopic dermatitis clinical trial, including the subset of eight Asian patients in the Corvus trial. This includes similar mean age, baseline EASI, baseline Investigator’s Global Assessment (IGA) and use of prior systemic therapies.
Corvus is enrolling patients in a Phase 1b clinical trial evaluating soquelitinib in patients with hidradenitis suppurativa (HS). The trial is designed to enroll up to 25 patients with moderate to severe HS. All patients will receive a soquelitinib dose of 200 mg twice per day for 12 weeks, followed by a 90-day follow-up period with no treatment. The primary endpoint of the trial is safety and tolerability. The key efficacy endpoint is the proportion of patients achieving Hidradenitis Suppurativa Clinical Response (HiSCR) 50/75 at week 12, and the trial will also evaluate skin and blood biomarkers. Initial data from the trial is anticipated in the 1H 2027.
Corvus plans to initiate a Phase 2 trial evaluating soquelitinib in patients with asthma, by Q1 2027. Angel Pharma anticipates that it will initiate a Phase 2 trial of soquelitinib in patients with asthma in Q2 2027.
Corvus also continues to advance its next-generation ITK inhibitor preclinical product candidates, which are designed to deliver precise T-cell modulation for specific immunology and oncology indications.
Collaboration with National Institute of Allergy and Infectious Diseases (NIAID)

The Autoimmune Lymphoproliferative Syndrome (ALPS) Phase 2 clinical trial continues to advance. This trial is being conducted under a clinical research and development agreement with NIAID. The Phase 2 clinical trial is anticipated to enroll up to 30 patients aged 16 or older with confirmed ALPS based on genetic testing.
Initial data from the ALPS Phase 2 trial was published in November 2026 in an abstract and will be presented in greater detail in a poster presentation at the 68th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting & Exposition in December 2026. Three patients have been treated in the trial, each completing 360 days of treatment at the 200 mg twice per day dose. The data is consistent with the safety profile observed in Corvus’ T cell lymphoma and atopic dermatitis trials and all three patients had a positive response to soquelitinib therapy. Key highlights include:
The treatment was well tolerated, with no grade 3 or 4 adverse events and no interruptions in therapy.
All three patients were able to discontinue background medications including steroids and reported improvement in ALPS related systemic symptoms.
The investigational new drug (IND) application for soquelitinib treatment of ALPS patients is planned to be transferred to Corvus. The Company plans to meet with the U.S. Food and Drug Administration (FDA) to expand the number of treatment centers and to reduce the age eligibility to include pediatric patients.
Soquelitinib for T Cell Lymphoma

Corvus continues to enroll patients in a registrational Phase 3 clinical trial of soquelitinib in patients with relapsed/refractory PTCL at multiple clinical sites. This randomized controlled trial is anticipated to enroll a total of 150 patients with relapsed/refractory PTCL and is evaluating soquelitinib versus physicians’ choice of either belinostat or pralatrexate chemotherapies. The primary endpoint of the trial is progression free survival. There are no FDA fully approved agents for the treatment of relapsed/refractory PTCL, and the FDA has granted soquelitinib Orphan Drug Designation for the treatment of T cell lymphoma and Fast Track designation for treatment of adult patients with relapsed or refractory PTCL after at least two lines of systemic therapy.
New biopsy analysis from patients with mycosis fungoides treated in the Company’s Phase 1/1b T cell lymphoma trial support soquelitinib’s mechanism of action, showing an inhibition of cancerous Th2 cells and a skewing to Th1 cells. The analysis was conducted by a team from Memorial Sloan Kettering Cancer Center and will be available online in the 2026 abstract supplement for the ASH (Free ASH Whitepaper) Annual Meeting.
Final data from the Phase 1/1b trial of soquelitinib in patients with T cell lymphoma were published in Blood, the peer-reviewed journal of the American Society of Hematology (ASH) (Free ASH Whitepaper). The publication discusses results demonstrating soquelitinib’s anti-tumor activity based on tumor intrinsic and tumor extrinsic effects on microenvironment which we believe supports the Company’s ongoing and planned soquelitinib clinical trials and highlights the ITK inhibition novel mechanism of action.
Financial Results
As of September 30, 2026, Corvus had cash, cash equivalents and marketable securities of $202.9 million compared to $56.8 million as of December 31, 2025. Cash, cash equivalents and marketable securities as of September 30, 2026 included approximately $189.4 million in net proceeds received in a financing completed on January 23, 2026. Based on its current plans, Corvus expects its cash, cash equivalents and marketable securities to fund operations into the second quarter of 2028.

Research and development expenses for the three months ended September 30, 2026 totaled $17.8 million compared to $8.5 million for the same period in 2025. The increase in research and development expenses of $9.3 million was primarily due to higher clinical trial costs associated with the development of soquelitinib as well as an increase in personnel related costs.

Net loss for the three months ended September 30, 2026 was $20.3 million compared to $10.2 million for the same period in 2025. Included in net loss for the three months ended September 30, 2026 and 2025 were non-cash losses of $0.9 million and $0.3 million, respectively, from Corvus’ investment in Angel Pharma. Total stock compensation expense for the three months ended September 30, 2026 was $2.8 million compared to $1.2 million for the same period in 2025.

(Press release, Corvus Pharmaceuticals, NOV 5, 2026, View Source [SID1234674303])