Autolus Moves MS Data To October 2027 — Its CEO Says Earlier Results Wouldn't Guide Development
Analysts challenged the longer wait and larger trial as Autolus raised its leukemia therapy sales outlook to at least $150 million.
Autolus Therapeutics, which reprograms patients’ immune cells to treat disease, pushed its first progressive multiple sclerosis data presentation from March to October 2027. On Tuesday’s earnings call, Chief Executive Officer Dr. Christian Itin said the earlier results would be too preliminary to guide development decisions, even as analysts questioned the wait and encouraging signals from competitors.
A Longer Test Of Disability
The central question for Autolus’ early-stage BOBCAT study is whether treatment can stop progressive MS from getting worse. Management wants to see disability scores stabilize—and stay stable—rather than rely on early changes in biological markers.
Itin said specialists at the October ACTRIMS/ECTRIMS meeting regarded initial cell-therapy findings as encouraging, but believed short observation periods could not establish lasting benefit. Their view, he said, was that interpreting disability scores requires at least 12 months of follow-up, with 24 months preferable.
Autolus expects its October 2027 presentation to include at least 12 months of observation for the initial 12 treated patients. Itin said another 12 patients would have six to 12 months of follow-up. The longer wait is for the public presentation, he stressed, rather than a slowdown in the trial: “We are on track with Bobcat and have no delay in the study.”
A Needham analyst challenged that distinction by pointing to positive competitor findings and asking why those signals were insufficient. Itin put Autolus’ own early observations in the same category: promising, but not yet enough to interpret clinical outcomes. Asked about a separate safety update, he said management plans to present an integrated assessment instead of preliminary indications.
Why Enroll 24 Patients
A Mizuho analyst asked why planned enrollment had increased from 18 to 24 patients, questioning whether the original sample could deliver the signal Autolus wanted. Itin said 18 patients were adequate for a safety assessment but a small group for evaluating effectiveness, particularly because the study tests two different pre-treatment regimens.
The study uses FLu/Cy and bendamustine to prepare patients for cell therapy. Itin said adding six patients would give management a more useful basis for judging clinical effects, and described enrollment as going well.
The choice of preparation matters to the balance between effectiveness and tolerability. Responding to an H.C. Wainwright analyst, Itin said FLu/Cy can temporarily reduce neutrophils, a type of white blood cell. Bendamustine has less impact on that blood-cell toxicity, he said, but has also been less effective as a preparation regimen in leukemia and lymphoma. Autolus is exploring whether it offers a useful alternative for autoimmune patients.
The same analyst asked whether waiting would affect the path toward a trial designed to support approval. Itin said longer observation had already been part of management’s decision process; the presentation change does not alter how it will choose a later trial’s design or timing. The March data, he said, “would not have been actionable from a development perspective or development decision perspective.”
Leukemia Sales Finance The Broader Bet
Autolus’ commercial base is AUCATZYL, a therapy for adults with B-cell precursor acute lymphoblastic leukemia that has returned or resisted treatment. It is sold in the United States and United Kingdom through authorized specialist centers and manufactured at the company’s Nucleus facility in Stevenage, U.K.
Chief Financial Officer Rob Dolski told analysts on Tuesday’s call that Autolus now expects combined U.S. and U.K. net product sales of at least $150 million in 2026, versus its previous $140 million–$150 million range. The initial outlook had been $120 million–$135 million. Third-quarter product revenue was $41.2 million, up 95% from a year earlier, while sales for the first nine months reached $113.1 million, up 122%.
Gross margin rose to 57% from 55% in the second quarter and a negative margin a year earlier. Management attributed the improvement to higher production volumes, lower manufacturing costs per batch, efficiency work and fewer inventory reserves and write-offs. Cost of sales fell to $17.9 million from $28.6 million a year earlier.
Autolus remained loss-making: its quarterly operating loss narrowed to $43.5 million from $71.6 million. Research and development spending rose to $30.9 million from $27.9 million, which management attributed mainly to clinical manufacturing supply costs.
Cash, cash equivalents and marketable securities totaled $248.4 million at September 30, versus $201.6 million at June 30. Dolski attributed the increase primarily to borrowing from Perceptive Advisors. The company expects funding to last into the second quarter of 2028, assuming anticipated sales and $100 million across the credit facility’s first and second tranches, including a $25 million second tranche.
Autoimmune Recruitment Still Moving
A William Blair analyst asked whether safety concerns elsewhere in cell therapy had slowed recruitment into Autolus’ autoimmune studies. Itin said management had not seen a visible effect on patient flow in its trials during the second half of the year, and described MS patients as particularly interested in joining studies.
Autolus’ autoimmune work also includes lupus. Its lupus nephritis study continues enrolling in five countries, with results expected in 2028. The company also scheduled longer-term lupus findings for presentation at Tuesday’s American College of Rheumatology meeting, including up to 25 months of adult follow-up.
Those programs extend the company beyond leukemia, but the MS question remains specific: whether an early response becomes sustained stabilization of disability. Management’s October 2027 timetable is designed to give it enough observation to make that judgment.
For BOBCAT, the next public assessment is planned for October 2027, when Autolus expects the initial 12 patients to have at least 12 months of follow-up.
Sources
- Autolus Therapeutics results release (Form 8-K, EX-99.1) — SEC EDGAR
- Autolus Therapeutics GAAP EPS of -$0.21 misses by $0.03, revenue of $41.24M beats by $1.21M (AUTL:NASDAQ) | Seeking Alpha — seekingalpha.com
- Autolus Therapeutics Reports Third Quarter 2026 Financial — globenewswire.com
- Autolus Therapeutics to Participate in the Jefferies Global — globenewswire.com
