On November 5, 2025 Nykode Therapeutics ASA (OSE: NYKD), a clinical-stage biopharmaceutical company dedicated to the discovery and development of novel immunotherapies, reported the presentation of new integrated multiomics and biomarker analyses from the phase 1/2 VB N-01 (NCT03548467) and phase 1 VB N-02 (NCT05018273) clinical trials of the individualized cancer vaccine VB10.NEO, designed using Nykode’s AI-powered NeoSELECT platform, at the 40th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) held in National Harbor, Maryland, 5-9 November 2025.

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The poster highlights the capabilities of Nykode’s proprietary AI-powered NeoSELECT platform, which enables individualized cancer vaccine design by integrating multiomics data to select neoantigens with a high potential to trigger clinically relevant tumor-specific immune responses.

In the phase 1/2 VB N-01 and phase 1 VB N-02 trials, VB10.NEO developed using NeoSELECT elicited neoantigen-specific T-cell responses in 94% and 100% of participants, respectively, across multiple solid tumor types. High-quality neoantigens prioritized by NeoSELECT showed enrichment of both overall and stable/amplified immunogenic responses, supporting prolonged and amplified neoantigen-specific immune responses after VB10.NEO vaccination.

"We are very proud of our in-house artificial intelligence and machine learning capabilities. It is great to see the strong performance of our immunogenicity predictions being confirmed across both clinical trials," said Agnete Fredriksen, CSO and Co-founder of Nykode Therapeutics. "While the N-01 cohort was highly heterogeneous and patients received multiple concurrent therapies, we note a favorable association between a higher number of high-quality immunogenic neoantigens and overall survival. This encouraging signal warrants confirmation in controlled studies with more homogeneous patient populations and earlier lines of treatment."

Poster Presentation Details

Abstract #: 117
Title: Integrative analyses of multiomics data and biomarker readout demonstrate clinical and immunological relevance of individualized vaccine design via the NeoSELECT platform
Session Date and Time: Friday, November 7, 2025 | 10:00 AM–7:00 PM ET

The poster will be available on the Nykode website on November 7, at: View Source

(Press release, Nykode Therapeutics, NOV 5, 2025, View Source [SID1234659471])

On November 5, 2025 Precision Biologics, Inc. reported in vitro and in vivo efficacy of its novel tumor-specific ADC (PB-vcMMAE-5) against human carcinomas expressing truncated core 2 O-glycans. Recent data for several human cancer types expressing truncated core 2 O-glycans will be presented in a poster at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting on November 7th, 2025, National Harbor, MD, USA.

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Poster title: In vitro and in vivo efficacy of the antibody-drug-conjugate (ADC) PB-vcMMAE-5 against human carcinoma expressing truncated core 2 O-glycans

Presentation of the poster will be made in person on the following date and location:

Friday, November 7th,  12:15pm – 1:45pm ET; & 5:35pm – 7pm ET

Gaylord National Resort and Convention Center,  National Harbor, MD, USA

Lower Level Atrium – Prince George’s ABC

Primary Category: Immuno-Conjugates and Chimeric Molecules

Abstract Number: 949

BACKGROUND:

Solid tumors remain largely unresponsive to immune checkpoint inhibitors, in part due to their ability to suppress the cytotoxic activity of immune cells infiltrating the tumor microenvironment. One of the disrupted pathways in these cancers is O-glycosylation, a feature particularly associated with cancer progression, metastasis, and poor prognosis.

One strategy to overcome resistance of solid tumor to immunotherapy is the employment of antibody-drug-conjugates (ADCs) selectively targeting cancer cells and not healthy tissues. We developed an ADC, designated PB-vcMMAE-5, composed of the following:

The monoclonal antibody (mAb): We used PB-223, an innovative mAb developed through affinity maturation of clinical stage mAb NEO-102 (Ensituximab), a chimeric human IgG1 mAb that targets truncated core 2 O-glycans, specifically expressed by cancer cells and not by healthy tissues. PB-223 does not bind to normal tissues and it internalizes into human cancer cell lines expressing its target.
The payload: Monomethyl auristatin E (MMAE) was used as payload. MMAE is a potent antimitotic agent that inhibits cell division by blocking the polymerization of tubulin and is the most common ADC payload used to be linked to antibodies in clinical development for oncologic applications.
The linker: mc-vc-PABc was used as a cleavable linker. PB-223 was conjugated to the linker-payload through a cysteine-based conjugation method.
The drug-to-antibody ratio (DAR) of PB-vcMMAE-5 is 3.92.

Study presented at SITC (Free SITC Whitepaper) Annual Meeting 2025 includes the following data:

PB-223 specific binding to human tumor tissues by immunohistochemistry (IHC): PB-223 binds selectively to human tumor tissues and not to human normal tissue. PB-223 strongly reacted with colorectal, pancreatic, lung, prostate, and ovarian tumor tissues.
In vitro  efficacy of PB-vcMMAE-5 against several human cancer cell lines: The in vitro cytotoxicity of PB-vc-MMAE-5 was evaluated in 9 human cancer cell lines, including prostate (PC-3, LnCAP), triple negative breast (HCC1937, MDA-MB-231), ER+,PR+,HER2+ breast (BT-474), squamous cell carcinoma of the lung (NCI-H226), ovarian (OV-90), colorectal (SW403), and pancreatic (CFPAC-1) cancer cell lines. This study shows that PB-vcMMAE-5 effectively killed all cell lines tested, with the highest percentage of killing observed against MDA-MB-231 (triple negative breast), LnCAP (prostate), OV-90 (ovarian), and NCI-H226 (lung) cancer cell lines.
In contrast, naked PB-223 mAb showed no killing in all cell lines tested.

In vivo safety of PB-vcMMAE-5 in mice: NOD-SCID mice bearing OV-90 (ovarian) xenografts were treated with weekly doses of PBS, MMAE alone, or PB-vc-MMAE-5 (1, 3, 6, or 9 mg/kg) for five weeks. Animal body weight was monitored regularly, twice a week, as an indirect measure of toxicity. The ADC PB-vcMMAE-5 was well tolerated in mice. No sign of distress and no loss of body weight were observed.
No significant changes in body weight, blood parameters including hematology and clinical chemistry, nor pathological changes in the liver, spleen, brain, or heart of mice treated with efficacious doses of the ADC were observed compared with control groups.
In vivo  efficacy of PB-vcMMAE-5 in mice: The efficacy of the ADC PB-vcMMAE-5 was assessed in OV-90 (ovarian) subcutaneous xenograft model established in NOD-SCID mice. The ADC PB-vcMMAE-5 was administered intravenously at doses 1, 3, 6 or 9 mg/kg, once per week for five weeks.
On day 31 from the first ADC infusion, most alive mice were sacrificed, and tumors were excised for histological analysis using Ki-67 staining to assess proliferating viable tumor cells. To further assess systemic toxicity and prolonged efficacy, three mice each from the 6 and 9 mg/kg groups were followed to day 45.

Data presented in this study show that PB-vcMMAE-5 induced significant tumor growth inhibition compared to controls in a dose-dependent manner.
The highest tumor growth inhibition was observed at 6 and 9 mg/kg doses.

In addition, analysis of tumors at day 45 showed absence of viable tumor cells and presence of tumor cells in necrosis, in mice treated with PB-vcMMAE-5 at 9 mg/kg.
Findings from this study showed that PB-vcMMAE-5 can kill human cancer cells expressing PB-223’s target, is not toxic in vivo in mice, and is highly effective in vivo at 9 mg/kg in NOD-SCID mice bearing human ovarian cancer. In addition, in a poster presented at AACR (Free AACR Whitepaper) Annual Meeting 2025 we reported that PB-vcMMAE-5 is stable in human plasma.

All these data suggest that PB-vcMMAE-5 has promising potential as a therapeutic option for a range of human malignancies expressing core 2 O-glycans.

The PDF of the poster will be available starting from November 5th, 2025, at the following link:

View Source

(Press release, Precision Biologics, NOV 5, 2025, View Source [SID1234659488])

On November 5, 2025 Oncopeptides reported interim report.

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(Presentation, Oncopeptides, NOV 5, 2025, View Source [SID1234661742]).

On November 5, 2025 Arvinas, Inc. (Nasdaq: ARVN), a clinical-stage biotechnology company creating a new class of drugs based on targeted protein degradation, reported financial results for the third quarter ended September 30, 2025, and provided a corporate update.

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"The third quarter was marked by meaningful pipeline progress and strategic decisions aimed at positioning the company for sustained long-term growth and value creation," said John Houston, Ph.D., Chairperson, Chief Executive Officer, and President of Arvinas. "We have entered the beginning of a data-rich period with multiple readouts from our early-stage clinical programs. We also presented the first preclinical data from ARV-027, our promising new clinical candidate that targets the root cause of spinal bulbar muscular atrophy. Looking ahead, our mission is clear: to drive innovation across our PROTAC degrader portfolio and deliver transformative therapies to patients."

3Q 2025 Business Highlights and Recent Developments

ARV-102: Oral PROTAC LRRK2 degrader

Presented positive data from two Phase 1 clinical trials in an oral session at the International Congress of Parkinson’s Disease and Movement Disorders.
In single ascending and multiple ascending doses in healthy volunteers, ARV-102 was generally well tolerated at single doses up to 200 mg and multiple daily doses up to 80 mg, with no discontinuations due to adverse events (AEs) or serious adverse events (SAEs) observed in the study population. ARV-102 showed:
Increased exposure in a dose-dependent manner in plasma and cerebrospinal fluid (CSF), the latter indicating brain penetration.
Greater than 90% reductions of LRRK2 protein in peripheral blood mononuclear cells (PBMCs) and greater than 50% reductions in CSF (repeated daily doses ≥20 mg).
Reduced plasma concentrations of phospho-Rab10T73 and urine concentrations of bis(monoacylglycerol)phosphate (BMP), a sensitive biomarker for modulation of the lysosomal pathway downstream of LRRK2 (repeated daily doses).
Significant decreases in lysosomal pathway markers and neuroinflammatory microglial markers previously shown to be elevated in patients with Parkinson’s disease harboring LRRK2 variants as measured by unbiased proteomic analysis of CSF (ARV-102 80 mg once daily for 14 days).
To the Company’s knowledge, this is the first time an investigational LRRK2 therapy has, at 14 days in healthy volunteers, shown effects on distal pathway biomarkers in CSF that are elevated in patients with Parkinson’s disease.
In the ongoing single ascending dose trial in patients with Parkinson’ disease, single doses of ARV-102 (50 mg or 200 mg) were well tolerated with only mild treatment-related AEs including headache, diarrhea, and nausea; no SAEs occurred. ARV-102 showed:
Dose-dependent increases in exposure in both plasma and CSF, the latter indicating brain penetration.
Median PBMC LRRK2 protein reductions of 86% with the 50 mg dose and 97% with the 200 mg dose.
Initiated the multiple dose cohort of the Phase 1 clinical trial in patients with Parkinson’s disease.
ARV-393: Oral PROTAC BCL6 degrader

Announced there have been multiple responses in early cohorts of both B-and T-cell lymphomas in the first-in-human Phase 1 trial in patients with non-Hodgkin lymphoma (NHL). The anticipated effective exposure level has not been achieved, and dose escalation in the trial is ongoing (ClinicalTrials.gov Identifier: NCT06393738).
ARV-806: Novel PROTAC KRAS G12D degrader

Presented new preclinical data at AACR (Free AACR Whitepaper)-NCI-EORTC AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper) highlighting its high potency and clear differentiation from both KRAS inhibitors and degraders currently in the clinic while also demonstrating:
Dose-dependent, selective, robust anti-tumor activity, with regressions across preclinical models of KRAS G12D-mutant cancers.
In vitro potency approximately 25 times greater than KRAS inhibitors and 40 times greater than the leading clinical-stage degrader.
Degradation >90% for 7 days after single dose and significant efficacy in models of pancreatic, colorectal, and lung cancer.
Initiated Phase 1 trial evaluating ARV-806 in patients with solid tumors harboring KRAS G12D mutations (ClinicalTrials.gov Identifier: NCT07023731).
ARV-027: Oral PROTAC polyQ-AR degrader

Presented new preclinical data at the International Congress of the World Muscle Society demonstrating induced robust degradation of polyQ-AR in human myotubes derived from spinal bulbar muscular atrophy (SBMA) patient-induced pluripotent stem cells, as well as:
Dose-dependent degradation of polyQ-AR in mouse muscle that was sustained for more than 24 hours (single oral dose).
Reductions in muscle monomeric polyQ-AR levels between 40-60%, improved muscle grip strength, and restored muscle endurance to wild-type levels in an SBMA mouse model.
Vepdegestrant: Oral PROTAC ER degrader
As part of Arvinas’ global collaboration with Pfizer, the companies:

Announced the U.S. Food and Drug Administration (FDA) acceptance of the New Drug Application (NDA) for vepdegestrant for the treatment of estrogen receptor 1 (ESR1) mutated, estrogen receptor-positive (ER+)/human epidermal growth factor receptor 2-negative (HER2-) advanced or metastatic breast cancer previously treated with endocrine-based therapy. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) action date of June 5, 2026.
Announced agreement with Pfizer to jointly select a third party for the commercialization and potential further development of vepdegestrant, with the goal of rapidly bringing it to patients, if approved.
Presented new patient-reported outcomes data from the Phase 3 VERITAC-2 clinical trial and Phase 2 results from the TACTIVE-N clinical trial at the 2025 European Society for Medical Oncology Congress:
Patient-reported outcomes data from the VERITAC-2 clinical trial highlighted that patients with ESR1-mutated disease treated with vepdegestrant reported a statistically significant delay in deterioration of overall quality of life, pain, and multiple functioning domains versus those who received fulvestrant.
The TACTIVE-N clinical trial, which evaluated neoadjuvant vepdegestrant in postmenopausal women with ER+/HER2– localized breast cancer, showed that neoadjuvant vepdegestrant demonstrated biological and clinical activity in this treatment-naïve, predominantly ESR1 wild-type population of postmenopausal women with ER+/HER2- localized breast cancer.
Anticipated Upcoming Milestones and Expectations

ARV-102: Oral PROTAC LRRK2 degrader

Initiate Phase 1b clinical trial in patients with progressive supranuclear palsy (1H 2026).
Present initial data from the multiple dose cohort of the Phase 1 clinical trial in patients with Parkinson’s disease (2026).
ARV-393: Oral PROTAC BCL6 degrader

Share preclinical data in combination with glofitamab in models of aggressive high grade DLBCL at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting (Dec. 6-9, 2025).
Share updated clinical data from the ongoing Phase 1 clinical trial in patients with NHL (ClinicalTrials.gov Identifier: NCT06393738) at a medical congress (2026).
Initiate enrollment in Phase 1 clinical trial in combination with glofitamab in patients with DLBCL (2026).
ARV-806: Novel PROTAC KRAS G12D degrader

Continue enrollment in the Phase 1 trial of ARV-806 in patients with solid tumors harboring KRAS G12D mutations (ClinicalTrials.gov Identifier: NCT07023731).
Share initial clinical data in patients with solid tumors harboring KRAS G12D mutations (2026).
ARV-027: Oral PROTAC polyQ-AR degrader

Initiate a first-in-human Phase 1 clinical trial in healthy volunteers, pending regulatory feedback (2026).
ARV-6723: Oral PROTAC HPK1 degrader

Present preclinical data at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting (Nov. 8, 2025).
Initiate Phase 1 clinical trial in patients with advanced solid tumors, pending regulatory feedback (2026).
Vepdegestrant: Oral PROTAC ER degrader
As part of Arvinas’ global collaboration with Pfizer, the companies plan to:

Identify and select a partner with the capabilities and expertise to maximize the commercial potential of vepdegestrant.
Financial Guidance
Based on its current operating plan, Arvinas believes its cash, cash equivalents, and marketable securities as of September 30, 2025, is sufficient to fund planned operating expenses and capital expenditure requirements into the second half of 2028.

Third Quarter Financial Results
Cash, Cash Equivalents, and Marketable Securities Position: As of September 30, 2025, cash, cash equivalents, and marketable securities were $787.6 million as compared with $1,039.4 million as of December 31, 2024. The decrease in cash, cash equivalents, and marketable securities of $251.8 million for the nine months ended September 30, 2025, was primarily related to cash used in operations of $233.1 million, repurchases of our common shares under our Stock Repurchase Program of $17.8 million, the purchase of lab equipment and leasehold improvements of $1.7 million.

Research and Development Expenses: Generally Accepted Accounting Principles (GAAP) Research and development (R&D) expenses were $64.7 million for the quarter ended September 30, 2025, as compared with $86.9 million for the quarter ended September 30, 2024. The decrease in R&D expenses of $22.2 million for the quarter was primarily due to a decrease in external expenses of $7.4 million and a decrease in compensation and related personnel expenses of $14.2 million, which are not allocated by program. External expenses include program-specific expenses, which decreased by $6.5 million, primarily driven by decreases in our vepdegestrant (ARV-471), luxdegalutamide (ARV-766), and bavdegalutamide (ARV-110) programs of $5.4 million, $4.7 million, and $2.4 million, respectively, partially offset by increases in ARV-806 of $4.3 million.

Non-GAAP R&D expenses were $56.9 million for the quarter ended September 30, 2025, as compared with $73.2 million for the quarter ended September 30, 2024, excluding $0.4 million of restructuring expense for the quarter ended September 30, 2025, and $7.4 million and $13.7 million of non-cash stock-based compensation expense for the quarters ended September 30, 2025, and 2024, respectively. A reconciliation of GAAP to non-GAAP financial measures used in this press release can be found at the end of this press release.

General and Administrative Expenses: GAAP General and administrative (G&A) expenses were $21.0 million for the quarter ended September 30, 2025, as compared with $75.8 million for the quarter ended September 30, 2024. The decrease in G&A expenses of $54.8 million for the quarter was primarily due to a decrease of $43.4 million for the termination of our laboratory and office space lease with 101 College Street LLC in August 2024, a decrease in personnel and infrastructure related costs of $7.3 million, and professional fees of $3.6 million.

Non-GAAP G&A expenses were $14.6 million for the quarter ended September 30, 2025, as compared with $64.8 million for the quarter ended September 30, 2024, excluding $0.6 million of restructuring related reversal of previously recognized expense for the quarter ended September 30, 2025, and $7.0 million and $11.0 million of non-cash stock-based compensation expenses for the quarter ended September 30, 2025, and 2024, respectively. A reconciliation of GAAP to non-GAAP financial measures used in this press release can be found at the end of this press release.

Revenue: Revenue was $41.9 million for the quarter ended September 30, 2025, as compared with $102.4 million for the quarter ended September 30, 2024. Revenue for the quarter is related to the Vepdegestrant (ARV-471) Collaboration Agreement with Pfizer and the collaboration and license agreement with Pfizer. The decrease of $60.5 million was primarily due to $76.7 million of decreased revenue from the Novartis License Agreement and the Novartis Asset Agreement, both of which were entered into during the three months ended June 30, 2024, and were completed by December 31, 2024, as the technology transfer of our ongoing and planned clinical trials of luxdegalutamide (ARV-766) were transitioned to Novartis. Revenue from the Vepdegestrant (ARV-471) Collaboration Agreement with Pfizer decreased by $3.1 million and revenue from the Bayer Collaboration Agreement decreased by $0.5 million as a result of the termination of the Bayer Collaboration Agreement in August 2024. The overall decrease was offset by the recognition of $20.0 million for achievement of a development milestone pursuant to the terms of the Novartis License Agreement.

Investor Call & Webcast Details
Arvinas will host a conference call and webcast today, November 5, 2025, at 8:00 a.m. ET to review its third quarter 2025 financial results and discuss recent corporate updates. Participants are invited to listen by going to the Events and Presentation section under the Investors page on the Arvinas website at www.arvinas.com. A replay of the webcast will be available on the Arvinas website following the completion of the event and will be archived for up to 30 days.

(Press release, Arvinas, NOV 5, 2025, View Source [SID1234659456])

On November 5, 2025 Recursion (Nasdaq: RXRX) a leading clinical stage TechBio company decoding biology to radically improve lives, reported business updates and financial results for its third quarter ended September 30, 2025.

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Recursion will host a (L)earnings Call on November 5, 2025 at 8:00 am ET / 6:00 am MT / 1:00 pm GMT from Recursion’s X, LinkedIn, and YouTube accounts giving analysts, investors, and the public the opportunity to ask questions of the company by submitting questions here: View Source

"Recursion continues to deliver on our internal pipeline, our strategic partnerships and the continued building and refinement of the Recursion OS. On the partnership front, we are proud to announce that with the option of our second neuro map in the Roche and Genentech collaboration, we’ve achieved over $500 million in upfront and milestone payments from our partners to date as we continue to deliver novel insights and advance programs for some of the toughest disease areas," said Chris Gibson, Co-Founder and CEO of Recursion. "This is only the beginning of the returns we expect to see on the investment in our platform. With a strong cash runway through the end of 2027, we look forward to delivering on our pipeline and proving that building an end-to-end AI-enabled platform—combining massive proprietary datasets with industry-leading supercomputing capabilities and sophisticated AI models—is the critical infrastructure we need to realize real change in our industry."

Summary of Business Highlights

Portfolio – Internal and Partnered Programs
a3q2025earningsdeck_pipelia.jpg

"Our progress this quarter underscores the power of translating the Recursion OS into meaningful pipeline momentum," said Najat Khan, Chief R&D and Chief Commercial Officer of Recursion. "We continued to advance our clinical programs, with REC-4881 in the TUPELO study moving toward additional data later this year. We also progressed REC-617 into its first combination study and nominated REC-7735 as a new development candidate. On the partnered side, the delivery of our first-in-kind microglia map with Roche and Genentech highlights how phenomics can open new frontiers in neuroscience and other complex disease areas. These are the kinds of bold but pragmatic steps — in our own programs and through collaborations — that will be essential as we work to turn our platform insights into transformative medicines for patients."

Internal Pipeline Updates:
•REC-617 (CDK7):
◦Recursion announced progress in its ELUCIDATE Phase 1/2 trial evaluating REC-617, a precision-designed oral CDK7 inhibitor. The monotherapy dose-escalation study established the maximum tolerated dose (MTD) at 10 mg once-daily, demonstrating a manageable safety profile and preliminary anti-tumor activity consistent with the December 2024 update.
◦As of September 29, 2025, 29 heavily pre-treated patients with advanced solid tumors had received REC-617 across six dose levels. Treatment was generally well tolerated, with the most common dose-limiting toxicities (DLTs) being nausea and thrombocytopenia. Grade ≥3 treatment-related adverse events (TRAEs) occurred in 27.6% of patients (n=8), with no Grade 4/5 TRAEs reported. Only 6.9% (n=2) discontinued due to a TRAE. Importantly, REC-617 demonstrated rates of GI-related toxicities consistent with best-in-class potential. Specifically, common GI toxicities with REC-617 treatment were diarrhea (69%), nausea (41%), and vomiting (28%). Toxicities reported for samuraciclib treatment also included diarrhea (82%), nausea (77%), and vomiting (80%) (Coombes et al, 2023).
◦REC-617 has shown early anti-tumor activity, including one confirmed partial response and five cases of stable disease. Pharmacokinetic data support dose-proportional exposure, rapid absorption, and a short half-life (~5 hours), in line with its design as a selective, reversible CDK7 inhibitor.

◦The ELUCIDATE study has now expanded into 2L+ platinum-resistant ovarian cancer (PROC), with a Phase 2 monotherapy cohort ongoing and a Phase 1 combination arm initiated. Combination regimens include bevacizumab plus paclitaxel or pegylated liposomal doxorubicin (PLD). Recursion is also leveraging Recursion OS insights to explore additional indications and dosing regimens for expansion cohorts.
•REC-7735 (PI3Kα H1047R):
◦Recursion announced progress on REC-7735, with nomination as a Development Candidate and IND-enabling studies now underway. REC-7735 is a precision-designed PI3K⍺ H1047R inhibitor generated using the Recursion OS. In preclinical studies, REC-7735 demonstrated significant tumor regressions at low doses, outperforming approved agents, while maintaining high selectivity (>100-fold) over wild-type PI3K⍺ to reduce the risk of dose-limiting hyperglycemia.
◦With a differentiated preclinical efficacy and tolerability profile, REC-7735 has the potential to be a best-in-class PI3K⍺ H1047R inhibitor for breast and other solid tumors harboring this mutation.

Upcoming Milestones:
•REC-4881 (MEK1/2): Additional data in FAP from the Phase 2 TUPELO study expected in December 2025
•REC-1245 (RBM39): Early Phase 1 safety and PK monotherapy data expected in 1H26
•REC-3565 (MALT1): Early Phase 1 safety and PK monotherapy data expected in 1H27
•REC-102 (ENPP1): Potential Phase 1 initiation expected in 2H26
•REC-7735 (PI3Kα H1047R): Potential Phase 1 initiation expected in 2H26
•Recursion is well on track for over $100 million in milestone payments by end of 2026
◦Programs are advancing towards potential development candidate designation over the next 12 months
◦Multiple neuroscience target validation programs advancing by leveraging the Recursion OS

Partnered Discovery Updates:
With the acceptance of the second neuro map and the $30 million milestone from Roche and Genentech, Recursion has now achieved more than $500 million in upfront and milestone payments from its partners. This milestone places Recursion among a small group of pre-commercial biotechnology companies to achieve such scale, underscoring the strength of its partnership strategy. These collaborations not only support the maintenance and expansion of the Recursion OS, but also provide access to insights from leading biopharma companies and the potential for future milestone payments exceeding $10 billion, as well as royalties across indications Recursion may not pursue independently.

•Roche and Genentech: Recursion announced that it has achieved a second $30 million milestone from its partner, Roche and Genentech. The payment follows the acceptance of a novel whole-genome phenotypic map ("phenomap") of microglial cells, which are critical for brain health and implicated in a wide range of neurodegenerative and neuroinflammatory diseases.
◦The milestone is part of a larger ongoing 10+ year collaboration to discover novel targets and develop potential therapeutic treatments for up to 40 programs in neuroscience and gastrointestinal oncology.
◦Together, Recursion, Roche and Genentech have identified a number of biological insights from the first neuroscience-focused phenomap, that could become novel targets of interest.
◦Roche and Genentech have already optioned an initial program in gastrointestinal oncology with additional potential targets/programs under exploration based off of 4 whole-genome GI oncology phenomaps accepted by the partner to date.
◦To date, Recursion has achieved $213 million in upfront and milestone payments through the collaboration.

•Sanofi: Recursion and Sanofi continue to advance multi-target collaboration for up to 15 best-in-class or first-in-class programs across oncology and immunology, with $130 million in upfront and milestone payments achieved to date. Each program has the potential for over $300 million in milestone payments.
◦Sanofi continues to leverage combined Recursion OS 2.0, including phenomics, to identify new program opportunities.
◦Recursion and Sanofi are further advancing and expanding their joint pipeline across oncology and immunology.
◦Several programs are continuing to advance towards potential lead series and development candidate designation over the next 12 months.

Platform
a3q2025earnings_finalxproga.jpg

Recursion OS 2.0: The platform is continuing to drive program development by integrating AI across multimodal biology, precision design, and clinical development—enabling faster, more efficient, and more innovative drug discovery and development.

Third Quarter 2025 Financial Results

•Cash Position: Cash, cash equivalents and restricted cash were $667.1 million as of September 30, 2025 compared to $603.0 million as of December 31, 2024. As of October 9, 2025, cash and cash equivalents was approximately $785 million (unaudited), following receipt of $387.5 million in net proceeds from the Company’s At-the-Market (ATM) facility during the third and fourth quarters of 2025, which is now fully utilized and completed. Based on current operating plans and with no additional financing, the Company’s expected cash runway extends through the end of 2027.
•Revenue: Total revenue, consisting primarily of revenue from collaboration agreements, was $5.2 million for the third quarter of 2025, compared to $26.1 million for the third quarter of 2024. The year over year change was primarily due to achievement of a $30 million milestone payment for the first phenomap from Roche and Genentech in August 2024, with the second $30 million milestone under the agreement achieved in October 2025, for which the company expects to recognize a portion as revenue in the fourth quarter of 2025.
•Research and Development Expenses: Research and development expenses were $121.1 million for the third quarter of 2025, compared to $74.6 million for the third quarter of 2024. The increase was primarily driven by the increase in acquired IPR&D purchases related to
the acquisition of full rights to REC-102, Recursion’s ENPP1 inhibitor, as well as the Company’s business combination with Exscientia in November 2024.
•General and Administrative Expenses: General and administrative expenses were $41.6 million for the third quarter of 2025 compared to $37.8 million for the third quarter of 2024. The increase compared to the prior period was primarily due to the inclusion of G&A expenses from the business combination with Exscientia.
•Net Loss: Net loss was $162.3 million for the third quarter of 2025, compared to a net loss of $95.8 million for the third quarter of 2024.
•Operational cash flows: Net cash used in operating activities was $325.7 million for the nine months ended September 30, 2025, compared to net cash used in operating activities of $243.7 million for the nine months ended September 30, 2024. The increase in cash used in operating activities was primarily driven by the inclusion of Exscientia’s operations, for which the business combination with Recursion closed in November 2024. This also included severance payments of $7.7 million in association with the restructuring activities announced in June 2025.

(Press release, Recursion Pharmaceuticals, NOV 5, 2025, View Source [SID1234659472])