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RNAC

Cartesian TherapeuticsC
Nasdaq / Pharmaceuticals, Biotechnology & Life Sciences
Last Price
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2026-06-02
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Latest report
2026-05-26
Investor release

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Earnings documents stored for RNAC.

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Investor releaseQuarter not tagged2026-05-26

Cartesian Therapeutics Secures up to $150 Million of Non-Dilutive Financing from K2 HealthVentures and Expects Topline Data from the Phase 3 AURORA Trial in First Quarter 2027

GlobeNewswire

Secured up to $150 million of non-dilutive financing from K2 HealthVentures; funding of $50 million from initial tranche extends cash runway into 2028 Financing strengthens Cartesian’s financial flexibility, further supporting advancement of multiple clinical programs to data read out including myasthenia gravis and myositis, while also accelerating pre-launch activities Topline data from Phase 3 AURORA trial of Descartes-08 in myasthenia gravis expected in 1Q27; BLA filing planned for mid-2027 Data from subset of patients in Phase 2 TRITON trial of Descartes-08 in myositis expected in 1H27 Data from Phase 1/2 HELIOS pediatric trial of Descartes-08 in juvenile dermatomyositis expected in 1H27 FREDERICK, Md., May 26, 2026 (GLOBE NEWSWIRE) -- Cartesian Therapeutics, Inc. (NASDAQ: RNAC) (the “Company”), a clinical-stage biotechnology company pioneering cell therapy for autoimmune diseases, today announced that it has entered into an agreement with K2 HealthVentures LLC (“K2HV”), an alternative investment firm that provides flexible, long-term financing solutions in life sciences, to provide a credit facility of up to $150 million including an initial $50 million tranche. The proceeds from the initial tranche under the credit facility are expected to allow the Company to accelerate the ongoing investment in the commercial launch preparation activities for Descartes-08 in myasthenia gravis (MG) and myositis and to extend cash runway into 2028. The Company also announced progress across its pipeline, including updated timelines for all ongoing trials of Descartes-08, an autologous anti-B cell maturation antigen (BCMA) mRNA chimeric antigen receptor T-cell therapy (CAR-T). “We are very excited to partner with K2 HealthVentures for this financing, which we expect to provide us with access to the additional capital necessary to help support our continued growth. With this additional financing, we believe we are now fully funded beyond anticipated timelines for achievement of three near-term clinical catalysts, including topline data from our Phase 3 AURORA trial in MG in the first quarter of 2027, data from our Phase 2 TRITON trial in myositis and data from our Phase 1/2 HELIOS trial in JDM,” said Carsten Brunn, Ph.D., President and Chief Executive Officer of Cartesian. “Descartes-08 remains the only CAR-T in autoimmune disease that we are aware of that is designed f...

Investor releaseQuarter not tagged2026-04-30

Cartesian Therapeutics Reports First Quarter 2026 Financial Results and Provides Business Update

GlobeNewswire

Enrollment continues to progress in Phase 3 AURORA trial of Descartes-08 in myasthenia gravis Phase 2 TRITON trial of Descartes-08 in dermatomyositis and antisynthetase syndrome initiated Multiple patients enrolled in Phase 1/2 HELIOS pediatric trial of Descartes-08 in juvenile dermatomyositis Approximately $120.4 million cash, cash equivalents and restricted cash as of March 31, 2026, expected to support planned operations into mid-2027, including completion of ongoing Phase 3 AURORA trial FREDERICK, Md., April 30, 2026 (GLOBE NEWSWIRE) -- Cartesian Therapeutics, Inc. (NASDAQ: RNAC) (“we”, the “Company” or “Cartesian”), a late clinical-stage biotechnology company pioneering cell therapy for autoimmune diseases, today reported financial results for the first quarter ended March 31, 2026, and outlined recent business updates. “Descartes-08 represents a significant opportunity to address the many unmet needs of patients living with autoimmune diseases, with the potential to simultaneously improve quality of life through depth and durability of response. With three clinical programs in progress, we remain focused on advancing this mission with near-term milestones across our pipeline,” said Carsten Brunn, Ph.D., President and Chief Executive Officer of Cartesian. “We continue to prioritize our myasthenia gravis (MG) program as we enroll patients into the Phase 3 AURORA trial. In parallel, we initiated our Phase 2 TRITON trial of adult patients with dermatomyositis and antisynthetase syndrome. We have also enrolled multiple patients in the Phase 1/2 HELIOS pediatric trial in juvenile dermatomyositis (JDM) and are encouraged by the early enrollment observed to-date. The momentum across all three programs strengthens our conviction in Descartes-08’s promise as we advance it toward its full potential.” Pipeline Progress and Anticipated Milestones Enrollment Continues to Progress in the Phase 3 AURORA Trial of Descartes-08 in Participants with MG. The randomized, double-blind, placebo-controlled Phase 3 AURORA trial is designed to assess Descartes-08, Cartesian’s autologous anti-B cell maturation antigen (BCMA) chimeric antigen receptor T-cell therapy (CAR-T) versus placebo (1:1 randomization) administered as six once-weekly outpatient infusions without preconditioning chemotherapy in approximately 100 patients with acetylcholine receptor autoantibody positive (AChR...

Investor releaseQuarter not tagged2026-03-09

Cartesian Therapeutics Reports Full Year 2025 Financial Results and Provides Business Update

GlobeNewswire

Enrollment continues to progress in Phase 3 AURORA trial of Descartes-08 in myasthenia gravis Phase 2 TRITON trial of Descartes-08 in dermatomyositis and antisynthetase syndrome, expected to initiate in 1H26 Phase 1/2 HELIOS pediatric trial of Descartes-08 in juvenile dermatomyositis actively enrolling Approximately $126.9 million cash, cash equivalents and restricted cash as of December 31, 2025, expected to support planned operations into mid-2027, including completion of ongoing Phase 3 AURORA trial FREDERICK, Md., March 09, 2026 (GLOBE NEWSWIRE) -- Cartesian Therapeutics, Inc. (NASDAQ: RNAC) (“we”, the “Company” or “Cartesian”), a late clinical-stage biotechnology company pioneering cell therapy for autoimmune diseases, today reported financial results for the year ended December 31, 2025, and outlined recent business updates. “Building on a productive year, we look forward to a potentially transformative 2026 as we advance Descartes-08 across several autoimmune indications,” said Carsten Brunn, Ph.D., President and Chief Executive Officer of Cartesian. “Our top priority remains delivering on our Phase 3 AURORA trial in myasthenia gravis (MG), for which we are on track to enroll approximately 100 patients. This trial represents a crucial opportunity to demonstrate the potential of Descartes-08 to improve patient outcomes and redefine the standard-of-care for MG. Descartes-08’s ease of use, including, flexible, convenient outpatient administration with no preconditioning chemotherapy, combined with deep and durable responses observed through 12 months following a single course of treatment, and a favorable safety profile, underscore our belief that Descartes-08 holds significant promise to deliver meaningful benefit to patients.” Dr. Brunn continued, “Beyond MG, we are working to activate sites for our Phase 2 TRITON trial of Descartes-08 in myositis, which we plan to initiate in the first half of 2026. In parallel, we are also excited to explore potentially enhanced cell therapy delivery options of existing product candidates and next generation agents in development through in-vivo platforms with multiple feasibility studies underway. With an upcoming year of focused clinical execution, we believe we are well-positioned to fill the significant unmet need that remains within the autoimmune treatment landscape.” Pipeline Progress and Anticipated Milestone...

Investor releaseQuarter not tagged2025-11-06

Cartesian Therapeutics Reports Third Quarter 2025 Financial Results and Provides Business Update

GlobeNewswire

Enrollment on track in Phase 3 AURORA trial of Descartes-08 in myasthenia gravis Preliminary data from Phase 2 trial of Descartes-08 in systemic lupus erythematosus expected by end of year Initiation of Phase 2 pediatric basket trial of Descartes-08 in select autoimmune indications expected by end of year Approximately $145.1 million cash, cash equivalents and restricted cash as of September 30, 2025, expected to support planned operations into mid-2027, including completion of ongoing Phase 3 AURORA trial FREDERICK, Md., Nov. 06, 2025 (GLOBE NEWSWIRE) -- Cartesian Therapeutics, Inc. (NASDAQ: RNAC) (“we”, the “Company” or “Cartesian”), a clinical-stage biotechnology company pioneering cell therapy for autoimmune diseases, today reported financial results for the third quarter ended September 30, 2025, and outlined recent corporate updates. “As we approach the end of what has been a productive year of meaningful progress in our mission to deliver transformative therapies for patients with autoimmune diseases, we remain focused on driving continued execution and enrollment in our Phase 3 AURORA trial of Descartes-08 in myasthenia gravis (MG),” said Carsten Brunn, Ph.D., President and Chief Executive Officer of Cartesian. “Supported by compelling results from our Phase 2b trial in which we observed deep and sustained benefits at Month 12 following a single course of therapy, we firmly believe Descartes-08, if approved, has the potential to serve as an impactful new therapy for patients with MG that can be administered safely in the outpatient setting and without the need for preconditioning chemotherapy. Beyond MG, we remain on track to share preliminary data from our ongoing Phase 2 trial of Descartes-08 in patients with systemic lupus erythematosus (SLE) and to initiate a pediatric basket trial in select autoimmune indications by the end of this year.” Recent Pipeline Progress and Anticipated Milestones Enrollment On Track in the Phase 3 AURORA Trial of Descartes-08 in Participants with MG. The randomized, double-blind, placebo-controlled Phase 3 AURORA trial is designed to assess Descartes-08, Cartesian’s autologous anti-B cell maturation antigen (BCMA) chimeric antigen receptor T-cell therapy (CAR-T) versus placebo (1:1 randomization) administered as six once-weekly outpatient infusions without preconditioning chemotherapy in approximately 100 participants...

Investor releaseQuarter not tagged2025-08-08

Cartesian Therapeutics Second Quarter 2025 Earnings: EPS Beats Expectations, Revenues Lag

Simply Wall St.

Net income: US$15.9m (up 65% from 2Q 2024). EPS: US$0.61 (up from US$0.58 in 2Q 2024). Trump has pledged to "unleash" American oil and gas and these 15 US stocks have developments that are poised to benefit. All figures shown in the chart above are for the trailing 12 month (TTM) period Revenue missed analyst estimates by 63%. Earnings per share (EPS) exceeded analyst estimates. Looking ahead, revenue is forecast to grow 78% p.a. on average during the next 3 years, compared to a 19% growth forecast for the Biotechs industry in the US. Performance of the American Biotechs industry. The company's shares are down 15% from a week ago. You still need to take note of risks, for example - Cartesian Therapeutics has 6 warning signs (and 2 which can't be ignored) we think you should know about. Have feedback on this article? Concerned about the content? Get in touch with us directly. Alternatively, email editorial-team (at) simplywallst.com. This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned.

Investor releaseQuarter not tagged2025-08-07

Cartesian Therapeutics Reports Second Quarter 2025 Financial Results and Provides Business Update

GlobeNewswire

Initiated Phase 3 AURORA trial of Descartes-08 in myasthenia gravis Preliminary data from Phase 2 trial of Descartes-08 in systemic lupus erythematosus expected in 2H25 Initiation of Phase 2 pediatric basket trial of Descartes-08 in select autoimmune indications expected in 2H25 Approximately $162.1 million cash, cash equivalents and restricted cash as of June 30, 2025, expected to support planned operations into mid-2027, including completion of ongoing Phase 3 AURORA trial FREDERICK, Md., Aug. 07, 2025 (GLOBE NEWSWIRE) -- Cartesian Therapeutics, Inc. (NASDAQ: RNAC) (the “Company” or “Cartesian”), a clinical-stage biotechnology company pioneering cell therapy for autoimmune diseases, today reported financial results for the second quarter ended June 30, 2025, and outlined recent corporate updates. “Following the recent initiation of our pivotal Phase 3 AURORA trial of Descartes-08 in myasthenia gravis (MG), we have entered the second half of the year with significant momentum as we continue to advance our mission to deliver transformative cell therapies to patients with autoimmune diseases,” said Carsten Brunn, Ph.D., President and Chief Executive Officer of Cartesian. “Supported by deep and sustained responses observed through month 12 in the Phase 2b trial along with a clearly defined regulatory pathway, we believe that, if approved, Descartes-08 has the potential to serve as an impactful new MG therapy with the ability to be safely dosed in the outpatient setting and without the need for preconditioning chemotherapy. Additionally, we continue to make progress advancing the balance of our programs and remain on track to share preliminary data from our ongoing Phase 2 trial of Descartes-08 in patients with systemic lupus erythematosus (SLE) and to initiate a pediatric basket trial in select autoimmune indications by the end of this year.” Recent Pipeline Progress and Anticipated Milestones Initiated Phase 3 AURORA Trial of Descartes-08 in Participants with MG. In May 2025, the Company announced that the first participant had been enrolled in the Phase 3 AURORA trial. The randomized, double-blind, placebo-controlled Phase 3 AURORA trial is designed to assess Descartes-08, Cartesian’s autologous anti-B cell maturation antigen (BCMA) chimeric antigen receptor T-cell therapy (CAR-T) versus placebo (1:1 randomization) administered as six once-weekly outpatient...

Investor releaseQuarter not tagged2025-05-11

Cartesian Therapeutics, Inc. (NASDAQ:RNAC) Just Released Its First-Quarter Results And Analysts Are Updating Their Estimates

Simply Wall St.

Cartesian Therapeutics, Inc. (NASDAQ:RNAC) investors will be delighted, with the company turning in some strong numbers with its latest results. Overall results were decent, with revenues of US$1.1m beating estimates by60%. Statutory losses were subsequently less thanthe analysts had expected, at US$0.65 per share. This is an important time for investors, as they can track a company's performance in its report, look at what experts are forecasting for next year, and see if there has been any change to expectations for the business. We've gathered the most recent statutory forecasts to see whether the analysts have changed their earnings models, following these results. We've found 21 US stocks that are forecast to pay a dividend yield of over 6% next year. See the full list for free. After the latest results, the consensus from Cartesian Therapeutics' eight analysts is for revenues of US$2.79m in 2025, which would reflect a sizeable 92% decline in revenue compared to the last year of performance. Per-share losses are expected to explode, reaching US$3.29 per share. Before this earnings announcement, the analysts had been modelling revenues of US$2.75m and losses of US$3.05 per share in 2025. So it's pretty clear consensus is mixed on Cartesian Therapeutics after the new consensus numbers; while the analysts held their revenue numbers steady, they also administered a modest increase to per-share loss expectations. See our latest analysis for Cartesian Therapeutics As a result, there was no major change to the consensus price target of US$37.33, with the analysts implicitly confirming that the business looks to be performing in line with expectations, despite higher forecast losses. Fixating on a single price target can be unwise though, since the consensus target is effectively the average of analyst price targets. As a result, some investors like to look at the range of estimates to see if there are any diverging opinions on the company's valuation. There are some variant perceptions on Cartesian Therapeutics, with the most bullish analyst valuing it at US$42.00 and the most bearish at US$22.00 per share. There are definitely some different views on the stock, but the range of estimates is not wide enough as to imply that the situation is unforecastable, in our view. These estimates are interesting, but it can be useful to paint some more broad strokes when...

Investor releaseQuarter not tagged2025-05-10

Cartesian Therapeutics First Quarter 2025 Earnings: Beats Expectations

Simply Wall St.

Revenue: US$1.10m (down 81% from 1Q 2024). Net loss: US$17.7m (loss narrowed by 69% from 1Q 2024). US$0.68 loss per share (improved from US$10.50 loss in 1Q 2024). AI is about to change healthcare. These 20 stocks are working on everything from early diagnostics to drug discovery. The best part - they are all under $10bn in marketcap - there is still time to get in early. All figures shown in the chart above are for the trailing 12 month (TTM) period Revenue exceeded analyst estimates by 60%. Earnings per share (EPS) also surpassed analyst estimates by 7.9%. Looking ahead, revenue is forecast to grow 58% p.a. on average during the next 3 years, compared to a 18% growth forecast for the Biotechs industry in the US. Performance of the American Biotechs industry. The company's shares are down 22% from a week ago. We don't want to rain on the parade too much, but we did also find 5 warning signs for Cartesian Therapeutics (3 can't be ignored!) that you need to be mindful of. Have feedback on this article? Concerned about the content? Get in touch with us directly. Alternatively, email editorial-team (at) simplywallst.com. This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned.

Investor releaseQuarter not tagged2025-05-08

Cartesian Therapeutics Reports First Quarter 2025 Financial Results and Provides Business Update

GlobeNewswire

Initiation of Phase 3 AURORA trial of Descartes-08 in myasthenia gravis expected in 2Q25; deep and sustained benefits observed through Month 12 after a single course of therapy in Phase 2b trial Preliminary data from Phase 2 trial of Descartes-08 in systemic lupus erythematosus expected in 2H25 Initiation of Phase 2 pediatric basket trial of Descartes-08 in select autoimmune indications expected in 2H25 Approximately $182.1 million cash, cash equivalents and restricted cash as of March 31, 2025 expected to support planned operations into mid-2027, including completion of planned Phase 3 AURORA trial FREDERICK, Md., May 08, 2025 (GLOBE NEWSWIRE) -- Cartesian Therapeutics, Inc. (NASDAQ: RNAC) (the “Company”), a clinical-stage biotechnology company pioneering cell therapy for autoimmune diseases, today reported financial results for the first quarter ended March 31, 2025, and outlined recent corporate updates. “We are off to a strong start in what we expect to be a productive year marked by several potential value-creating milestones across our pipeline,” said Carsten Brunn, Ph.D., President and Chief Executive Officer of Cartesian. “This includes the recent presentation of updated data from our Phase 2b trial of Descartes-08 in participants with myasthenia gravis (MG), in which we observed deep and sustained benefits at Month 12 following a single course of therapy, particularly in participants without exposure to prior biologic therapies. These data underscore the potential of Descartes-08, which is designed to be dosed conveniently in an outpatient setting without the need for preconditioning chemotherapy, to truly transform the current treatment paradigm, and we look forward to commencing our Phase 3 AURORA trial by the end of this quarter.” Dr. Brunn continued, “In addition, progress continues across the balance of our pipeline, with preliminary data from our ongoing Phase 2 trial of Descartes-08 in patients with systemic lupus erythematosus (SLE), as well as the initiation of a pediatric basket trial in select autoimmune diseases, expected in the second half of this year.” Recent Pipeline Progress and Anticipated Milestones Announced Positive Updated Long-Term Results from Phase 2b Trial of Descartes-08 in Participants with MG, with Sustained Benefits Observed Through 12 Months After a Single Course of Therapy. In April 2025, the Company announced updated...

Investor releaseQuarter not tagged2025-03-14

Cartesian Therapeutics Full Year 2024 Earnings: EPS Beats Expectations, Revenues Lag

Simply Wall St.

Revenue: US$38.9m (up 50% from FY 2023). Net loss: US$77.4m (loss narrowed by 70% from FY 2023). US$4.48 loss per share (improved from US$49.76 loss in FY 2023). All figures shown in the chart above are for the trailing 12 month (TTM) period Revenue missed analyst estimates by 2.1%. Earnings per share (EPS) exceeded analyst estimates by 24%. Looking ahead, revenue is forecast to grow 37% p.a. on average during the next 3 years, compared to a 20% growth forecast for the Biotechs industry in the US. Performance of the American Biotechs industry. The company's shares are down 6.9% from a week ago. We should say that we've discovered 4 warning signs for Cartesian Therapeutics (3 are a bit concerning!) that you should be aware of before investing here. Have feedback on this article? Concerned about the content? Get in touch with us directly. Alternatively, email editorial-team (at) simplywallst.com. This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned.

Investor releaseQuarter not tagged2025-03-13

Cartesian Therapeutics Reports Full Year 2024 Financial Results and Provides Business Update

GlobeNewswire

Phase 3 AURORA trial of Descartes-08 in myasthenia gravis on track to commence in 1H25; Deep and durable responses maintained over 12 months in Descartes-08-treated participants in Phase 2b trial Phase 2 trial of Descartes-08 in systemic lupus erythematosus ongoing with expected data readout in 2H25 Company expects to initiate Phase 2 pediatric basket trial of Decartes-08 in select autoimmune indications in 2H25 Dosing underway in first-in-human Phase 1 trial of Descartes-15 Approximately $214.3 million cash, cash equivalents and restricted cash as of December 31, 2024 expected to support planned operations into mid-2027, including completion of planned Phase 3 AURORA trial FREDERICK, Md., March 13, 2025 (GLOBE NEWSWIRE) -- Cartesian Therapeutics, Inc. (NASDAQ: RNAC) (the “Company”), a clinical-stage biotechnology company pioneering mRNA cell therapy for autoimmune diseases, today reported financial results for the full year ended December 31, 2024, and outlined recent corporate updates. “Following a year marked by tremendous progress, we remain committed to advancing our pipeline of mRNA cell therapies designed to be dosed in the convenient outpatient setting, without the need for preconditioning chemotherapy,” said Carsten Brunn, Ph.D., President and Chief Executive Officer of Cartesian. “Notably, we remain on track to commence our planned Phase 3 AURORA trial of Descartes-08 in patients with myasthenia gravis (MG) in the first half of this year. Supported by positive results from our Phase 2b trial demonstrating deep and durable improvements for Descartes-08-treated participants, along with our Special Protocol Assessment (SPA) agreement with U.S. Food and Drug Administration (FDA), we are confident that we have a clear path toward potential approval of this promising new therapy.” Dr. Brunn continued, “Beyond MG, we remain on track to report preliminary data from our ongoing Phase 2 open-label trial of Descartes-08 in patients with systemic lupus erythematosus (SLE) and expect to initiate our Phase 2 pediatric basket trial of Descartes-08 in select autoimmune diseases in the second half of this year. With these anticipated milestones, along with our strong balance sheet, we believe we are well-positioned to deliver on our mission to expand the reach of cell therapy to autoimmunity.” Recent Pipeline Progress and Anticipated Milestones Phase 3 AURORA Trial...

TranscriptFY2023 Q22023-08-17

FY2023 Q2 earnings call transcript

Earnings source - 53 paragraphs
Operator

Good morning, everyone, thank you for joining the Selecta Biosciences Q2 2023 earnings call. At this time, all participants are in a listen-only mode. Following management's remarks, we will hold a question-and-answer session. At that time, lines will be open for you. If anyone should require operator assistance, please press star zero on your touchtone telephones. At this time, I'd like to turn the floor over to Blaine Davis, Chief Financial Officer at Selecta. Please go ahead.

Blaine Davis

Good morning, everyone, thank you for joining our second quarter 2023 financial results and business update conference call. The press release reporting our financial results is available in the Investors and Media section of Selecta's website at www.selectabio.com. In our quarterly report on Form 10-Q for the quarter ended June 30th, 2023, which was filed earlier this morning with the Securities and Exchange Commission. Joining me on today's call are Selecta's President and Chief Executive Officer, Dr. Carsten Brunn, and Peter Traber, our Chief Medical Officer. During today's call, we will be making certain forward-looking statements, including, without limitation, statements about the potential safety, efficacy, and regulatory and clinical progress of our product candidates, our financial projections, and our future expectations, plans, partnerships, and prospects.

Blaine Davis

These statements are subject to various risks that are described in the filings made with the SEC, including our most recent report on Form 10-K and quarterly report on Form 10-Q. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of today, August 17th, 2023, and Selecta disclaims any obligation to update such statements except as required by law, even if management views change. With that, I'd now like to turn the call over to Carsten.

Carsten Brunn

Good morning. Thank you everyone for taking the time to join us. Thus far, 2023 has proven to be an important year for ImmTOR, our precision immune tolerance platform, which we're leveraging to develop tolerogenic therapies that selectively mitigate unwanted immune responses. In March, we were thrilled to share positive data on both phase III trials of SEL-212 in patients with chronic refractory gout. As a reminder, SEL-212 consists of two components. First, pegadricase, a potent enzyme that has been observed to reduce serum urate in refractory gout patients who continue to have serious disease symptoms, such as debilitating joint pain and disfiguring tissue deposits of urate called tophi. Second, ImmTOR, which is our non-encapsulated formulation, rapamycin, that is designed to condition the immune system to reduce antibody formation to drugs that are administered at the same time.

Carsten Brunn

The proposed mechanism of ImmTOR action is the induction of immune tolerance rather than immune suppression, as with other commonly used drugs. In May, we had the opportunity to showcase this positive data during a late-breaking session at the European Alliance of Associations for Rheumatology or EULAR Congress. This was the first scientific presentation of our data to the key opinion leaders and physicians who treat patients with gout and who are well aware of the limitations of current treatment options. We were extremely encouraged by the response to the data, which reinforces our belief that SEL-212 could potentially serve as a once-monthly, safe, and effective urate-based intervention for refractory chronic gout, without the need for separate oral traditional immunosuppressants. We're currently focused on working with Sobi, our SEL-212 development partner, to prepare for a Biologics License Application or BLA filing in the U.S.

Carsten Brunn

The filing remains on track for the first half of 2024. As a reminder, under our agreement, Sobi is responsible for regulatory and commercial activities in all markets outside of China, while Selecta is responsible for ImmTOR manufacturing. Selecta is entitled to receive up to $615 million in remaining milestone payments from Sobi, as well as tiered double-digit royalties on net sales. With the potential for peak sales of SEL-212 for the treatment of chronic refractory gout to exceed $700 million, we believe that SEL-212 has the potential to deliver significant and meaningful long-term stockholder values. Importantly, the SEL-212 program serves as a validation for ImmTOR platform, which represents the only immune tolerance platform with positive phase III data.

Carsten Brunn

While we firmly believe that the balance of our pipeline beyond SEL-212 has the potential to generate meaningful returns for our stockholders, we recognize that significant capital and time would be required to advance these assets to value-creating inflection points on our own. As such, we want to taken the decision to suspend further investments in all programs beyond SEL-212, and instead plan to pursue potential licensing and corporate development initiatives for these assets. These include ImmTOR, which can be combined with a variety of therapeutic approaches to reduce immunogenicity across a range of indications. ImmTOR-IL, which combines our proprietary regulatory T-cell selective IL-2 candidate with ImmTOR, SEL-302, an AAV gene therapy combined with ImmTOR for the treatment of MMA, Xork, a next-generation IgG protease for the mitigation of pre-existing anti-AAV antibodies, and our next-generation IgA protease for IgA nephropathy.

Carsten Brunn

To note, we'll continue to work with our partner, Astellas, to advance the development of Xork in combination with AT845, Astellas' AAV-based therapy for the treatment of late-onset Pompe disease in adults. As a reminder, we have observed a unique low cross-reactivity profile in Xork that may provide therapeutic benefit to patients with pre-existing immunity to AAV. We believe our actions today will enable us to preserve capital and also to maintain stockholder interest in SEL-212, without dilution that would have been necessary to support the continued development of the balance of our pipeline assets over the long term. With that, I'll now turn the call over to Blaine to review second quarter financial results.

Blaine Davis

Thanks, Carsten. The second quarter financial results are detailed in the press release and 10-Q issued earlier this morning, let me focus my comments on some key points. Selecta ended of the second quarter with cash, cash equivalents, restricted cash, marketable securities of $115 million. As a result of the initiatives we announced today, we expect these resources will be sufficient to extend our operating requirements into 2027. Collaboration and license revenue for the quarter of 2023 was $5.2 million, as compared to $39.3 million in the second quarter of 2022. Collaboration and license revenue was primarily related to the shipment of clinical supply and the reimbursement of costs incurred for the Phase III DISSOLVE program under the license agreement with Sobi.

Blaine Davis

Research and development expenses for the second quarter of 2023 were $17.8 million, versus $19.2 million for the second quarter of 2022. The decrease was primarily related to the capital prioritization initiative that was enacted in the second quarter of 2023. G&A expenses for the second quarter of 2023 were $6.1 million, as compared to $6.2 million for the same period in 2022. The decrease was primarily the result of a reduction in expenses incurred for stock compensation. For the second quarter of 2023, we reported a net loss of $11.4 million, or basic net loss per share of $0.07. Let me turn the call back over to Carsten for some closing comments.

Carsten Brunn

In summary, we believe the initiatives we've announced today represent the best path forward to maximize long-term stockholder value. We look forward to continuing to work with Sobi in preparation for the planned BLA filing for SEL-212 in patients with chronic refractory gout in the first half of 2024, and for the balance of our pipeline, look forward to exploring opportunities to partner these programs in the coming weeks and months. Now, I'd like to open the line to Q&A. Operator?

Operator

Ladies and gentlemen, at this time, we'll begin the question-and-answer session. To ask a question, you may press star and one using a touchtone telephone. To withdraw your questions, you may press star and two. If you are using a speakerphone, we do ask that you please pick up the handset prior to pressing the numbers to ensure the best sound quality. Once again, that is star and then one to join the question queue. Our first question today comes from Joseph Schwartz from Leerink Partners. Please go ahead with your question.

Joseph Schwartz

Hi, thanks very much for the update. I was wondering, since you alluded to the limitations of current treatment options for treatment refractory gout and Krystexxa sales have been quite strong, I was wondering if you could walk us through how the SEL-212 value proposition will compare to Krystexxa and how you get to your market opportunity estimates? Thank you.

Carsten Brunn

Yeah, thanks. That's a great- that's a great question, Joe. Yeah, so we're-- we, we remain very encouraged. We have done some market research recently, which confirms the potential. I think we, we believe that a key differentiator is the fact that this is a monthly potential therapy, and where we don't have to use an oral immune suppressant, whereas it's a, it's a very targeted approach. With ImmTOR, you, you basically induce tolerance. We believe that, given the strong efficacy profile we have seen in the phase III, with the, you know, safety and tolerability we've also observed, given the once monthly dosing, we, we think there's a tremendous market opportunity. We're actually encouraged by the strong sales of Krystexxa. I think it's a great backdrop.

Carsten Brunn

It's a very attractive market, with significant potential.

Joseph Schwartz

Okay, thanks. Which of the pipeline programs do you think could garner the most interest with partners? Have you, you know, had any intelligence from, you know, the market for such assets? What is the timeline for securing partnerships, and what form of partnership would you seek to enter versus would be less interesting for Selecta?

Carsten Brunn

Yes, I think we, we believe, obviously, there's value in all our assets, but I think specifically, you know, we, we had initially focused on ImmTOR-IL, and we think that remains a very attractive asset for partnering and specifically for use in autoimmune disease. You know, we, we believe that adding ImmTOR to an IL-2 is, is really differentiating, actually. We're excited about this, but we believe Xork has, you know, holds potential value, but also the IgA protease in combination with ImmTOR. I think all those assets-... are, are of high value. We have not reached out to potential partners at this point. We'll do so in the, the coming weeks and months, and we'll keep the market updated.

Joseph Schwartz

Thank you for taking my questions.

Carsten Brunn

Thank you, Joe.

Operator

Our next question comes from Kristen Kluska from Cantor Fitzgerald. Please go ahead with your question.

Kristen Kluska

Hi, good morning, everybody. For ImmTOR-IL, curious to hear more about the decision here, given I know how excited you've been on this program. I guess, why not conduct some initial IND-enabling studies in-house and then look to partner off of this? You know, would that be too expensive with your plans? Then just given the versatility of the program, even perhaps outside of autoimmune, how do you plan on approaching partners?

Carsten Brunn

Yeah, I think the, the why now is a good question, Kristen. I think we've just looked at the development costs and the timelines to get to a meaningful clinical readout versus the high value of SEL-212, and came to the conclusion that it's, it's in our stockholders' interest, to stop all investment, basically. We, we haven't, you know, talked about our partnering strategy, but I think the, the low-hanging fruit is really what we were focused on initially, which is ImmTOR-IL, for the use in autoimmune diseases, I think, because we have, you know, pretty detailed development program in place already. I think there's also value in some of the larger autoimmune indications where maybe IL-2 alone struggles. I think that's another approach where, you know, the differentiation by adding ImmTOR to the mix, you know, might be helpful also.

Carsten Brunn

We'll update the markets, you know, once we, we had some initial discussions.

Kristen Kluska

Okay, thanks. With your new cash runway guidance, I'm curious how much of this is implementing any potential milestone and/or royalty payments?

Blaine Davis

Yeah, Kristen, so the way we thought about the runway, we've, we've only incorporated the next regulatory milestone in the calculation of our cash runway. As you think about, you know, the potential BLA filing in the first half of 2024, we haven't built in any future milestones or royalties to that calculation around 2027. You know, we, we feel that that runway, you know, represents a conservative approach. As SEL-212 moves forward through the regulatory process, obviously, we will look, look at that cash runway and look at the initiatives we put into place and the ultimate impact on the cash runway overall.

Blaine Davis

you know, in 2027, we feel very comfortable with, and we've only incorporated a, a single, regulatory milestone into the calculation of that runway.

Kristen Kluska

Okay, got it. Thanks. You've certainly kept us on our toes on partnerships in the past, so looking forward to seeing what comes out of that in the next months here. Thank you.

Blaine Davis

Thanks, Kristen.

Operator

Our next question comes from John Newman from Canaccord. Please go ahead with your question.

John Newman

Hi, guys. Good morning, and thanks for taking my question. The question is, you've got a very interesting structure around the royalties from SEL-212 with Sobi. If I can remember correctly, you basically don't pay taxes on those royalties. My question is, will you look to retain that royalty structure long term, in order to bring in potentially substantial royalties that will be tax-free? Are you considering monetizing that royalty, as it's, it's pretty unique. We see a lot of royalties monetized, but very few, if any, that have a tax-free structure. Thanks.

Carsten Brunn

Yeah, that's a great question, John. We haven't made a final decision on this at this point, but you are right. We have tax optimized this royalty stream, which I think a lot of investors actually haven't fully appreciated. We basically won't pay any taxes up to an amount of about $400 million, actually, which is very significant. We have not made a decision. I think for now, we just want to, you know, maximize the potential value for our stockholders.

John Newman

Great. Thank you.

Operator

Our next question comes from Gil Blum, from Needham & Company. Please go ahead with your question.

Gil Blum

Good morning, thanks for taking our question. With the refocusing of... Just, just to help us understand, with the refocusing of, of your efforts here, what additional oomph can you get to, you know, help SEL-212 along? Is, is this gonna, you know, change anything in your current relationship with Sobi? Just, just to help us understand. Thank you.

Carsten Brunn

Yeah, I don't think there is a change, Gil. We obviously, working closely with Sobi to support the BLA filing. We remain responsible for the ImmTOR manufacturing. I think what's important as well, we get reimbursed for those efforts, right? I think that, that doesn't change in our plans moving forward.

Gil Blum

Okay. And maybe kind of as a follow-on, what would you say is, you know, the, the next big thing for us to focus on, on, on the street? Thank you.

Carsten Brunn

I think we're putting the focus on SEL-212, and really the next big kind of milestone look for is actually the filing off the BLA in the first half of 2024, and then, you know, look for potential partnerships that for the remainder of the pipeline.

Operator

Our next question comes from Uy Ear from Mizuho. Please go ahead with your question.

Uy Ear

Guys, thanks for taking my question. Just curious, is there any conditions or financial conditions that would allow you to maybe reverse course? Are you considering partnership for ImmTOR and everything as a sort of the way going forward? Thanks.

Carsten Brunn

Yeah, obviously, we're, we looked at this very carefully, and we believe, what we've announced today is the best path forward.

Uy Ear

Okay. How should we kind of think about spending, because, you know, this quarter, it didn't look like the, there was a significant change from first quarter to second quarter, and your cash runway sort of imply that spending would come down significantly? Would it be sort of immediately in the third and fourth quarter, or, it's sort of more in the 2024 timeframe? Thanks.

Blaine Davis

Yeah. A couple of comments there. You know, as you might remember, the way we report R&D expense, it is inclusive of SEL-212 related activities. As Carsten mentioned, that is a fully reimbursed set of expenses. While, while you might see some ups and downs in reported R&D, we also would receive revenue from those reported expenses, specifically associated with SEL-212. On the whole, when you look at overall R&D spend, it will continue to come down as it relates specifically to the initiatives we announced earlier this year, as well as the update that we provided today. That will carry forward through the second half of this year, and then also throughout 2024 as well.

Blaine Davis

Again, there's a little bit of a, a nuance there in the sense that the way with which we report the SEL-212 related expenses, those will obviously continue as we move forward in partnership with Sobi and moving to BLA. But overall, we do expect to see R&D expenses come down as we move forward from here.

Uy Ear

Okay, thank you.

Operator

Once again, if you would like to ask a question, please press Star and then one. Our next question comes from Dipesh Patel from H.C. Wainwright. Please go ahead with your question.

Dipesh Patel

Hi, good morning, team. Thanks for the update. A few questions from us. Firstly, you indicated that you are interested in potential partnerships to advance the pipeline. Maybe, just to take a step back, can you give us a sense of or maybe a high-level update regarding the circumstances that led to the termination of agreements you formerly signed with Takeda, Sarepta, and Spark? What implications or what pointers or lessons we can learn from this that could potentially help you, you know, as you think about future partnerships?

Carsten Brunn

Yeah, that's a good, that's a good question. Obviously, if you look at specifically Takeda partnership, Takeda decided to exit AAV gene therapy and disbanded this unit completely, they terminated all partnerships, including ours. You know, Sarepta decided not to move forward. Obviously we, we had positive data along the way, as was shown by the milestone payments we received, but they ultimately decided against this. We're definitely, you know, we have a lot of experience doing partnerships, and you know, we're positive that we'll be able to monetize the various assets, and not only in gene therapy. I think, you know, we have a much broader potential pipeline as well.

Dipesh Patel

Okay, thanks for the color. Then, late April, you announced a targeted headcount reduction of 25%. Today, so let's say after implementing today's update, how many employees you might possibly have?

Carsten Brunn

Yeah, we, we are not announcing a RIF today, and we haven't guided to that. I think today is really focused on announcing that we are focusing efforts on SEL-212, and that requires obviously quite a bit of, you know, headcount, which is reimbursed by Sobi, and we're looking to partner our assets out. We're not announcing a RIF at today at this point.

Dipesh Patel

All right. Thanks so much.

Operator

Ladies and gentlemen, it's showing no additional questions. I'd like to turn the floor back over to Carsten Brunn for any closing remarks.

Carsten Brunn

Thank you, operator, and thank you, everyone, for joining our call today.

Operator

Ladies and gentlemen, with that, we'll conclude today's conference call and presentation. We thank you for joining. You may now disconnect your lines.

As of 2026-05-30 • Updated weeklySource: Earnings sourceIngestion runbook