Autolus Therapeutics Announces Preliminary Unaudited Fourth Quarter and Full Year 2025 Net Product Revenue, Pipeline Advancements and Outlook for 2026
Rhea-AI Summary
Autolus (NASDAQ: AUTL) reported preliminary unaudited AUCATZYL® (obe-cel) net product revenue of approximately $24M for Q4 2025 and $75M for full-year 2025, and issued 2026 revenue guidance of $120M–$135M. Independent ROCCA real-world data confirmed strong clinical activity and a favorable safety profile. Key clinical updates include a 95.5% ORR in pediatric r/r B-ALL (CATULUS Phase 1) and selection of 50M cells as the Phase 2 dose in lupus nephritis (LUMINA). The company expects positive gross margin in 2026 and sufficient cash to fund operations into Q4 2027.
Positive
- AUCATZYL net revenue ~$75M in 2025 (first commercial year)
- 2026 revenue guidance of $120M–$135M
- CATULUS pediatric r/r B-ALL ORR of 95.5%
- Selected 50 million cells as recommended Phase 2 dose for lupus nephritis
- Cash runway expected into Q4 2027
Negative
- Preliminary 2025 results unaudited and subject to change after close and audit
- Company previously reported negative gross margin and must execute manufacturing changes to achieve positive margin in 2026
- Full Phase 2 enrollment for CATULUS not expected until H1 2027, delaying registrational timelines
News Market Reaction
On the day this news was published, AUTL declined 17.13%, reflecting a significant negative market reaction. Argus tracked a trough of -21.2% from its starting point during tracking. Our momentum scanner triggered 41 alerts that day, indicating elevated trading interest and price volatility. This price movement removed approximately $95M from the company's valuation, bringing the market cap to $459M at that time. Trading volume was above average at 1.7x the daily average, suggesting increased trading activity.
Data tracked by StockTitan Argus on the day of publication.
Key Figures
Market Reality Check
Peers on Argus
AUTL fell 5.24% while momentum scans only flagged biotech peer FULC, which rose 5.28%. Broader close peers (ADCT, BNTC, CGEM, YMAB, AURA) show mixed, mostly modest moves, indicating a stock-specific reaction rather than a coordinated sector move.
Historical Context
| Date | Event | Sentiment | Move | Catalyst |
|---|---|---|---|---|
| Jan 06 | Manufacturing partnership | Positive | +7.5% | Evaluation of Cellares Cell Shuttle to boost AUCATZYL manufacturing throughput. |
| Dec 08 | Clinical data lupus | Positive | +2.6% | Updated Phase 1 CARLYSLE data in severe refractory systemic lupus erythematosus. |
| Dec 08 | Clinical data pediatric | Positive | +2.6% | ASH data showing high remission rates and favorable safety in pediatric r/r B‑ALL. |
| Dec 01 | Board appointment | Neutral | -2.1% | Appointment of Ryan Richardson to the Board to support commercial transition. |
| Nov 25 | NICE recommendation | Positive | +12.1% | NICE draft guidance recommending AUCATZYL for adult r/r B‑ALL via NHS commissioning. |
Recent positive clinical, regulatory and manufacturing news has generally coincided with positive next-day price reactions.
Over the last few months, Autolus reported multiple milestones centered on AUCATZYL and obe‑cel. NICE draft guidance in Nov 2025 recommending AUCATZYL and ASH 2025 data updates in pediatric r/r B‑ALL and srSLE were followed by positive price reactions. Manufacturing automation plans with Cellares on Jan 6, 2026 also saw a gain. A board appointment in Dec 2025 drew a modest pullback. Today’s preliminary 2025 revenue and 2026 guidance extend this commercial and clinical progress narrative.
Market Pulse Summary
The stock dropped -17.1% in the session following this news. The decline reflects a divergence from prior reactions, where positive AUCATZYL and obe‑cel updates typically saw gains, including moves of 2.58%–12.1% around ASH and NICE news. Despite preliminary 2025 net product revenue of $75 million and 2026 guidance of $120–$135 million, concerns could center on execution risk, future trial readouts, or expectations around margins and cash runway into Q4 2027, which may have prompted profit-taking.
Key Terms
overall response rate medical
cytokine release syndrome medical
immune effector cell-associated neurotoxicity syndrome medical
systemic lupus erythematosus medical
lupus nephritis medical
progressive multiple sclerosis medical
Phase 1 medical
Phase 2 medical
AI-generated analysis. Not financial advice.
- Company expects preliminary unaudited AUCATZYL® net product revenue of approximately
$24 million for the fourth quarter of 2025 and approximately$75 million for the full year of 2025 - Autolus anticipates full year 2026 AUCATZYL® net product revenue of
$120 million to$135 million - Independent real-world AUCATZYL® data from ROCCA consortium confirm high level of clinical activity with favorable safety profile
- Focus for 2026 is:
- Driving AUCATZYL® top line growth
- Optimizing manufacturing operation to improve gross margin and innovating on next generation manufacturing platform
- Progressing the CATULUS, LUMINA and BOBCAT trials to expand the utility of obe-cel in pediatric hem-oncology and autoimmune indications
LONDON and Gaithersburg, Md., Jan. 12, 2026 (GLOBE NEWSWIRE) -- Autolus Therapeutics plc (Nasdaq: AUTL), a commercial-stage biopharmaceutical company developing, manufacturing and delivering next-generation programmed T cell therapies, today announced preliminary unaudited net product revenue from sales of AUCATZYL® (obecabtagene autoleucel; obe-cel) for the fourth quarter and full year of 2025. The Company also announced pipeline advancement updates and anticipated future milestones.
AUCATZYL® 2025 Preliminary Unaudited Net Product Revenues, Commercial Updates and 2026 Revenue Guidance
Dr. Christian Itin, Chief Executive Officer of Autolus, said: “We had a successful launch of AUCATZYL in the US with full year sales well above expectations and more than 60 centers offering treatment. We established reliable, high-quality product delivery with short and consistent turn-around time. Parallel to the launch and independent from the Company, the ROCCA consortium collected real-world data for AUCATZYL in adult r/r B-ALL patients and presented initial data at ASH 2025. The real-world data confirmed a high level of clinical activity and a favorable safety profile for AUCATZYL consistent with prior clinical trial results, and we believe this positive customer experience will be a key driver for the future growth of AUCATZYL in 2026.
“In addition to our launch of AUCATZYL in the US, we obtained regulatory approvals in the UK and EU. We successfully navigated the challenging pricing and reimbursement process with NICE, establishing cost effectiveness of AUCATZYL for the NHS and initiating our commercial launch in the UK in December under routine commissioning – a first for a CAR T therapy in the UK.”
Based on preliminary unaudited financial information, Autolus expects net product revenue from sales of AUCATZYL to be approximately
For 2026, the Company projects net product revenue for AUCATZYL of between
Pipeline Updates and Upcoming Clinical Milestones
Dr. Matthias Will, Chief Development Officer of Autolus, said: “In 2025 we reported strong initial clinical data for the Phase 1 CATULUS trial in pediatric r/r B-ALL patients and in the Phase 1 CARLYSLE trial in patients with severe lupus erythematosus. Both data sets form a compelling basis for progressing those studies in pediatric B-ALL and in lupus nephritis to Phase 2. With this strong foundation of clinical data, Phase 2 studies enrolling and demonstrated commercial and manufacturing capabilities, we believe Autolus is well positioned to drive growth with obe-cel in additional and significant indications.”
Obe-cel data in pediatric r/r B-ALL
- Preliminary data from the CATULUS Phase 1 trial of obe-cel in pediatric relapsed or refractory (r/r) B-ALL patients were presented at the American Society of Hematology (ASH) Annual Meeting. Obe-cel demonstrated high remission rates in pediatric patients with high-risk r/r B-ALL with overall response rate (ORR) of
95.5% . Low rates of high-grade cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS) were observed, consistent with obe-cel’s adult safety profile. Autolus is now advancing obe-cel into the Phase 2 portion of the trial and expects to have the trial fully enrolled in the first half of 2027.
Obe-cel in lupus nephritis (LN)
- Data from the ongoing Phase 1 CARLYSLE trial in patients with severe refractory systemic lupus erythematosus (srSLE) were reported at the American Society of Hematology (ASH) Annual Meeting. All patients show deep B-cell depletion after infusion, suggesting an immune reset. No ICANS or high-grade CRS were observed in the nine patients evaluable for safety.
- Data support progressing obe-cel as a treatment for LN and 50 million cells was selected as the recommended Phase 2 dose. Autolus has previously aligned with the US Food and Drug Administration (FDA) on a Phase 2 trial design in LN and potential registrational path to approval. The LUMINA trial is now enrolling.
Obe-cel in progressive multiple sclerosis (MS)
- Autolus is advancing obe-cel into initial clinical development to explore treatment in progressive MS. The first patient in the BOBCAT trial was dosed in October 2025. The Phase 1 trial, expected to include up to 18 adult patients, will determine the safety, tolerability, and preliminary efficacy of obe-cel in participants with refractory progressive forms of MS. Initial data from the trial are expected to be reported at the end of 2026.
AUTO8 in light-chain amyloidosis
- The first patient was dosed in the Phase 1 ALARIC trial in AL amyloidosis and initial data is expected to be reported at the end of 2026.
Operational Updates & 2026 Outlook
Dr. Christian Itin concluded: “Our 2026 commercial focus for AUCATZYL is to build on the strong center presence and positive physician experience to drive top line growth, while improving margins by reducing our manufacturing costs per batch. Our development focus is on progressing our pivotal pediatric ALL CATLULUS and lupus nephritis LUMINA studies and the exploratory BOBCAT study in progressive multiple sclerosis. Our plans for innovation will focus on manufacturing technology and European market access.”
Increasing patient numbers in 2026 will improve manufacturing plant utilization and together with operational efficiencies, Autolus expects a shift from previously reported negative gross margin to positive gross margin in 2026.
Autolus has initiated an overall manufacturing life cycle plan to facilitate additional cost reductions and gross margin improvements as the Company plans to expand obe-cel into new indications and pursue larger market opportunities. The initiatives are focused on: 1) optimizing the Company’s current manufacturing operating model; 2) enhancing automation opportunities for the Company’s existing manufacturing process; and 3) developing a next-generation manufacturing platform with a step change in the cost and capacity profile. The Company plans to provide a detailed update on these plans in mid-2026.
Based on current operating plans, including anticipated AUCATZYL® net revenues, Autolus expects that its current and projected cash, cash equivalents and marketable securities will be sufficient to fund the Company’s operations into Q4 2027.
Financial Disclosure Advisory1
This press release contains certain estimated preliminary unaudited financial results for the fourth quarter and year ended December 31, 2025. These estimates are based on the information available to the Company at this time. The Company’s financial closing procedures for the fourth quarter and year ended December 31, 2025 are not yet complete and, as a result, actual results may vary from the estimated preliminary results presented here due to the completion of the Company’s financial closing and audit procedures. The estimated preliminary financial results have not been audited or reviewed by the Company’s independent registered public accounting firm. These estimates should not be viewed as a substitute for the Company’s full interim or annual financial statements.
About Autolus Therapeutics plc
Autolus Therapeutics plc (Nasdaq: AUTL) is a commercial-stage biopharmaceutical company developing, manufacturing and delivering next-generation T cell therapies and candidates for the treatment of cancer and autoimmune disease. Using a broad suite of proprietary and modular T cell programming technologies, Autolus is engineering precisely targeted and controlled T cell therapies that are designed to better recognize target cells, break down their defense mechanisms and eliminate these cells. Autolus has a marketed therapy, AUCATZYL®, and a pipeline of product candidates in development for the treatment of hematological malignancies, solid tumors and autoimmune diseases. For more information, please visit www.autolus.com.
About AUCATZYL® (obecabtagene autoleucel; obe-cel)
AUCATZYL is a B-lymphocyte antigen CD19 (CD19) chimeric antigen receptor (CAR) T cell therapy designed to overcome the limitations in clinical activity and safety compared to current CD19 CAR T cell therapies. AUCATZYL is designed with a fast target binding off-rate to minimize excessive activation of the programmed T cells. AUCATZYL was approved by the FDA for the treatment of adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia on November 8, 2024, and was granted conditional marketing authorization by MHRA in the UK and EMA in the EU in 2025.
INDICATION
AUCATZYL® is a CD19-directed genetically modified autologous T cell immunotherapy indicated for the treatment of adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).
IMPORTANT SAFETY INFORMATION
| WARNING: CYTOKINE RELEASE SYNDROME, NEUROLOGIC TOXICITIES, and SECONDARY HEMATOLOGICAL MALIGNANCIES |
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WARNINGS AND PRECAUTIONS
Cytokine Release Syndrome (CRS)
Cytokine Release Syndrome (CRS) occurred following treatment with AUCATZYL. CRS was reported in
Cytokine Release Syndrome (CRS) occurred following treatment with AUCATZYL. CRS was reported in
Prior to administering AUCATZYL, ensure that healthcare providers have immediate access to medications and resuscitative equipment to manage CRS. During and following treatment with AUCATZYL, closely monitor patients for signs and symptoms of CRS daily for at least 7 days following each infusion. Continue to monitor patients for CRS for at least 2 weeks following each infusion with AUCATZYL. Counsel patients to seek immediate medical attention should signs or symptoms of CRS occur at any time. At the first sign of CRS, immediately evaluate the patient for hospitalization and institute treatment with supportive care based on severity and consider further management per current practice guidelines.
Neurologic Toxicities
Neurologic toxicities including Immune Effector Cell-associated Neurotoxicity Syndrome (ICANS), which were fatal or life-threatening, occurred following treatment with AUCATZYL. Neurologic toxicities were reported in
The median time to onset of neurologic toxicities was 10 days (range: 1 to 246 days) with a median duration of 13 days (range: 1 to 904 days). Fifty-five percent of patients (35/64) experienced neurologic toxicities after the first infusion but prior to the second infusion of AUCATZYL with a median time to onset of 6 days (range: 1 to 11 days). Among patients with neurologic toxicities, the most common symptoms (>
Immune Effector Cell-associated Neurotoxicity Syndrome (ICANS)
ICANS events occurred in
During and following AUCATZYL administration, closely monitor patients for signs and symptoms of Neurologic Toxicity/ICANS. Following treatment with AUCATZYL, monitor patients daily for at least 7 days. Continue to monitor patients for at least 2 weeks following treatment with AUCATZYL. Avoid driving for at least 2 weeks after each infusion. Counsel patients to seek medical attention should signs or symptoms of neurologic toxicity/ ICANS occur. At the first sign of Neurologic Toxicity/ICANS, immediately evaluate patients for hospitalization and institute treatment with supportive care based on severity and consider further management per current practice guidelines.
Prolonged Cytopenias
Patients may exhibit cytopenias including anemia, neutropenia, and thrombocytopenia for several weeks after treatment with lymphodepleting chemotherapy and AUCATZYL. In patients who were responders to AUCATZYL, Grade ≥ 3 cytopenias that persisted beyond Day 30 following AUCATZYL infusion were observed in
Infections
Severe, including life-threatening and fatal infections occurred in patients after AUCATZYL infusion. Non-COVID-19 infections of all grades occurred in
Grade 3 or higher febrile neutropenia was observed in
Viral reactivation, potentially severe or life-threatening, can occur in patients treated with drugs directed against B cells. There is no experience with manufacturing AUCATZYL for patients with a positive test for human immunodeficiency virus (HIV) or with active hepatitis B virus (HBV) or active hepatitis C virus (HCV). Perform screening for HBV, HCV and HIV in accordance with clinical guidelines before collection of cells for manufacturing.
Hypogammaglobulinemia
Hypogammaglobulinemia and B-cell aplasia can occur in patients after AUCATZYL infusion. Hypogammaglobulinemia was reported in
Immunoglobulin levels should be monitored after treatment with AUCATZYL and managed per institutional guidelines including infection precautions, antibiotic or antiviral prophylaxis, and immunoglobulin replacement.
The safety of immunization with live viral vaccines during or following treatment with AUCATZYL has not been studied. Vaccination with live viral vaccines is not recommended for at least 6 weeks prior to the start of lymphodepleting chemotherapy treatment, during AUCATZYL treatment, and until immune recovery following treatment with AUCATZYL.
Hemophagocytic Lymphohistiocytosis/Macrophage Activation Syndrome (HLH/MAS)
HLH/MAS including fatal and life-threatening reactions occurred after treatment with AUCATZYL. HLH/MAS was reported in
Hypersensitivity Reactions
Serious hypersensitivity reactions, including anaphylaxis, may occur due to dimethyl sulfoxide (DMSO), an excipient used in AUCATZYL. Observe patients for hypersensitivity reactions during and after AUCATZYL infusion.
Secondary Malignancies
Patients treated with AUCATZYL may develop secondary malignancies. T cell malignancies have occurred following treatment of hematologic malignancies with BCMA- and CD19-directed genetically modified autologous T cell immunotherapies. Mature T cell malignancies, including CAR-positive tumors, may present as soon as weeks following infusion, and may include fatal outcomes. Monitor lifelong for secondary malignancies. In the event that a secondary malignancy occurs, contact Autolus at 1-855-288-5227 for reporting and to obtain instructions on the collection of patient samples for testing.
Adverse Reactions
The safety of AUCATZYL was evaluated in the FELIX study in which 100 patients with relapsed or refractory B-cell acute lymphoblastic leukemia (B-ALL) received AUCATZYL at a median dose of 410 × 106 CD19 CAR-positive viable T cells (range: 10 to 480 × 106 CD19 CAR-positive viable T cells with
The most common serious adverse reactions of any Grade (incidence ≥
Please see full Prescribing Information, including BOXED WARNING and Medication Guide.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are statements that are not historical facts, and in some cases can be identified by terms such as "may," "will," "could," "expects," "plans," "anticipates," and "believes." These statements include, but are not limited to, statements regarding Autolus’ future expectations, plans and prospects, including the anticipated level of fourth quarter 2025 and full year 2025 AUCATZYL net product revenue and guidance on 2026 AUCATZYL net product revenue and gross margin; Autolus’ anticipated cash runway; the expected timing of the release of Autolus’ fourth quarter and full year 2025 financial results in March 2026; the therapeutic potential and expected clinical benefits of AUCATZYL (obe-cel; obecabtagene autoleucel) for adult patients with r/r B-ALL and obe-cel in additional indications including LN and progressive MS; Autolus’ ability to generate revenues from AUCATZYL; Autolus’ ability to obtain and maintain regulatory approval for obe-cel for adult r/r B-ALL in additional territories and the timing thereof; expectations regarding the commercialization, marketing and manufacturing of AUCATZYL for adult r/r B-ALL, including expanding into additional territories and the related timing of reaching patients in such territories; the development of obe-cel in autoimmune indications and of additional product candidates, including statements regarding the initiation, timing, progress and the results of clinical studies or trials and related preparatory work; the period during which the results of clinical studies or trials will become available; Autolus’ plans to expand, develop and enhance its manufacturing activities; and Autolus’ pursuit of expanded market access across Europe. Any forward-looking statements are based on management's current views and assumptions and involve risks and uncertainties that could cause actual results, performance, or events to differ materially from those expressed or implied in such statements. These risks and uncertainties include, but are not limited to, the risks identified in the section titled "Risk Factors" in Autolus' Annual Report on Form 10-K filed with the Securities and Exchange Commission (the SEC), on March 20, 2025 and its subsequent Quarterly Reports on Form 10-Q, as well as discussions of potential risks, uncertainties, and other important factors in Autolus' subsequent filings with the SEC. All information in this press release is as of the date of the release, and Autolus undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise, except as required by law. You should, therefore, not rely on these forward-looking statements as representing Autolus’ views as of any date subsequent to the date of this press release.
Contact:
Amanda Cray
+1 617-967-0207
a.cray@autolus.com
FAQ
How much net product revenue did Autolus (AUTL) report for full-year 2025?
What is Autolus's 2026 revenue guidance for AUCATZYL (AUTL)?
What were the key clinical results for obe-cel in pediatric B-ALL in Autolus's update?
When does Autolus expect CATULUS Phase 2 to be fully enrolled?
What operational goals did Autolus highlight for 2026 to improve margins?
How long is Autolus's reported cash runway based on current plans?
