Stiff-Person Syndrome

Accelerating clinical path to commercialization in stiff person syndrome, myasthenia gravis and lupus nephritis Aligned with the U.S. Food and Drug Administration (FDA) on a registrational Phase 2 trial design for ongoing KYSA-8 trial in stiff person syndrome; 70% of study enrolled with topline data expected in 1H 2026; Biologics License Application (BLA) filing targeted for 2026 Clinical data in myasthenia gravis and lupus nephritis expected in 2H 2025 Strong balance sheet extends cash runway into 2027 through key clinical and regulatory catalysts EMERYVILLE, Calif., March 27, 2025 /PRNewswire/ -- Kyverna Therapeutics, Inc. (Nasdaq: KYTX), a clinical-stage biopharmaceutical company focused on developing cell therapies for patients with autoimmune diseases, today reported its business highlights and financial results for the full year 2024. "Kyverna's first year as a public company was a transformative one, as we demonstrated our leadership position in autoimmune CAR T. We have treated the most CAR T patients in neuroinflammatory and rheumatologic diseases with our differentiated construct, and our clinical experience to date highlights the potential for profound clinical outcomes in autoimmune patients," said Warner Biddle, Chief Executive Officer of Kyverna. "Kyverna has entered 2025 and its next phase of growth with the right strategy and a strong team in place to advance late-stage development of KYV-101 in our three priority indications – stiff person syndrome, myasthenia gravis and lupus nephritis – each with a clear and rapid path to market. We are pleased with our progress in our lead indication, stiff person syndrome, following alignment with the FDA on our registrational trial, KYSA-8, which is an important milestone as we advance KYV-101 toward its first BLA filing in 2026." Fourth Quarter 2024 Highlights and Recent Business Updates KYV-101: Autologous, fully human CD19 CAR T-cell product candidate, incorporating highly potent CD28 co-stimulation. KYV-101 is currently being evaluated in company-sponsored KYSA trials and investigator-initiated trials in numerous B cell mediated autoimmune diseases with a prioritized focus in stiff person syndrome, myasthenia gravis and lupus nephritis. Stiff Person Syndrome (SPS) Kyverna has aligned with the FDA on a registrational Phase 2 design for its ongoing KYSA-8 trial in SPS, which has enrolled 70% of study participants. Completion of enrollment is expected in mid-2025. The Company expects to report topline data from this study in the first half of 2026 and anticipates submitting its first BLA in 2026. The Company received a Regenerative Medicine Advanced Therapy (RMAT) designation and Orphan Drug Designation from the FDA for this program. Kyverna continues to progress its chemistry, manufacturing, and controls (CMC) readiness efforts in support of this anticipated BLA filing and has successfully onboarded ElevateBio to manufacture Kyverna's clinical trial product for KYV-101 in SPS. Myasthenia Gravis (MG) Kyverna's Phase 2 trial in MG, KYSA-6, has completed patient enrollment in an initial 6-patient cohort and the Company plans to report interim data from this cohort in the second half of 2025. The Company continues to engage in positive dialogue with the FDA and plans to provide an update on the registrational path for KYV-101 in the first half of this year. The Company received an RMAT Designation and Fast Track Designation from the FDA as well as Orphan Drug Designation from both the FDA and European Medicines Agency for this program. Lupus Nephritis (LN) Kyverna is currently advancing two Phase 1/2 trials in LN, KYSA-1 and KYSA-3. Kyverna has completed the dose-escalation cohort of KYSA-1 and is now treating patients at the target dose and expects to report Phase 1 data from both of these trials in the second half of 2025. The Company has received Fast Track Designation from the FDA for this program. In November 2024, Kyverna presented clinical data at American College of Rheumatology (ACR) Convergence 2024 demonstrating positive sustained efficacy and durability at >6-month follow-up observed in patients with severe LN treated with KYV-101 at the target dose. Additional Indications Kyverna is efficiently exploring additional opportunities for KYV-101 beyond the Company's priority indications through sponsored clinical trials and investigator-initiated trials (IITs) across numerous other autoimmune diseases, including systemic sclerosis and multiple sclerosis. Data from these efforts will inform selection of the next priority indication(s) to accelerate into late-stage development. KYV-102: Next-generation candidate incorporating our patented fully human CD19 CAR T and the Company's proprietary whole-blood rapid manufacturing approach, which aims to improve the CAR T patient experience, eliminate apheresis and broaden CAR T access. Kyverna expects to file an investigational new drug application for KYV-102 in the second half of 2025. Corporate Updates Strengthened management team with addition of Warner Biddle, Chief Executive Officer; Naji Gehchan, MD, MSc, MBA, Chief Medical and Development Officer; Dan Maziasz, Chief Business Officer; Cara Bauer PhD, Chief Human Resources Officer; and Tracy Rossin, Senior Vice President of Corporate Affairs, Communications and Investor Relations. Appointed Christi Shaw and Mert Aktar to the Board of Directors, bringing decades of industry leadership in corporate strategy and manufacturing expertise, including gene and cell therapy. Anticipated Milestones Kyverna has issued the following guidance on upcoming program milestones: SPS: Complete Pivotal Phase 2 Enrollment mid-2025 Report Topline Pivotal Phase 2 Data 1H 2026 BLA filing in 2026 MG: Confirm Registrational Path with Regulators 1H 2025 Report Interim Phase 2 Data 2H 2025 LN: Report Phase 1 Data 2H 2025 Future Pipeline: File KYV-102 IND application 2H 2025 Financial Results for the Year Ended December 31, 2024 Kyverna reported $286.0 million in cash, cash equivalents, and available-for-sale marketable securities as of December 31, 2024. The Company expects this to provide a cash runway into 2027, which is sufficient to achieve key inflection points across its priority indications. For the year ended December 31, 2024, the Company reported a net loss of $127.5 million, or a net loss per common share of $3.33, compared to a net loss of $60.4 million, or a net loss per common share of $89.61, for the same period in 2023. During the year ended December 31, 2024, net cash used in operating activities was $114.3 million, compared to $52.4 million for the same period in 2023. About KYV-101 Uniquely designed, KYV-101 is an autologous, fully human CD19 CAR T-cell product candidate with highly potent CD28 co-stimulation and designed for tolerability, which is under investigation for B-cell-driven autoimmune diseases. With KYV-101, Kyverna is pioneering a durable disease-clearing approach aiming for deep B cell depletion, an immune system reset, and long-term remission in autoimmune diseases. KYV-101 is currently being evaluated in a company-sponsored, open-label, pivotal Phase 2 trial in stiff person syndrome, a Phase 2 trial in myasthenia gravis and Phase 1/2 trials for lupus nephritis, as well as in investigator-initiated trials and company-sponsored trials for multiple indications. The clinical experience to date with KYV-101 highlights the potential for transformative clinical outcomes in autoimmune patients. About KYV-102 KYV-102 leverages the same fully human, clinically validated CD19 CAR-T construct as KYV-101. It incorporates the Ingenui-T platform, a proprietary, next-generation process that utilizes whole blood with a rapid manufacturing approach. Kyverna intends to broaden CAR T patient access with KYV-102 by eliminating the need for apheresis starting material and reducing the manufacturing turnaround time from conventionally manufactured CAR T products. About Kyverna Therapeutics Kyverna Therapeutics, Inc. (Nasdaq: KYTX) is a clinical-stage biopharmaceutical company focused on liberating patients through the curative potential of cell therapy. Kyverna's lead CAR T-cell therapy candidate, KYV-101, is advancing through clinical development with Phase 2 trials for stiff person syndrome and myasthenia gravis, and two ongoing multi-center Phase 1/2 trials for patients with lupus nephritis. The Company is also harnessing investigator-initiated trials and other KYSA studies, including in multiple sclerosis and systemic sclerosis, to inform the next priority indications for the Company to advance into late-stage development. Its pipeline includes next-generation CAR T-cell therapies in both autologous and allogeneic formats with properties intended to be well suited for use in B cell-driven autoimmune diseases. For more information, please visit . Forward-looking Statements Statements in this press release about future expectations, plans and prospects, as well as any other statements regarding matters that are not historical facts, may constitute "forward-looking statements." The words, without limitation, "anticipate," "believe," "continue," "could," "estimate," "expect," "intend," "may," "plan," "potential," "predict," "project," "should," "target," "will," "would" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these or similar identifying words. Forward-looking statements in this press release include, without limitation, those related to: Kyverna's strategic priorities and focus; the status of its Phase 2 trial in stiff person syndrome as a pivotal trial; the potential for KYV-101 to be the first-to-market in stiff person syndrome; the potential for KYV-102 to improve the patient experience and broaden CAR T access; anticipated milestones and timing thereof, including anticipated timing for the first intended BLA submission for KYV-101 and timing for reporting data as well as expected completion of enrollments; the speed at which any approvals may be obtained; Kyverna's engagement with regulators; Kyverna's anticipated cash runway; and Kyverna's clinical trials, investigator initiated trials and named-patient activities. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: uncertainties related to market conditions, the possibility that the FDA or other regulatory agencies may conclude that Kyverna's Phase 2 trial in stiff person syndrome is not sufficient to be registration-enabling and may require additional trials or studies to support its intended BLA submission; and other factors discussed in the "Risk Factors" section of Kyverna's most recent Annual Report on Form 10-K and Quarterly Reports on Form 10-Q that Kyverna has filed or may subsequently file with the U.S. Securities and Exchange Commission. Any forward-looking statements contained in this press release are based on the current expectations of Kyverna's management team and speak only as of the date hereof, and Kyverna specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise. For more information, please contact: Investors: [email protected] Media: [email protected] SOURCE Kyverna Therapeutics WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

iStock/ Jian Fan Having established success in cancer, biopharma is now looking to leverage CAR T therapies against a new target, autoimmune disorders, with several early- to mid-stage readouts expected this year. In September 2022, an intriguing report went up on Nature Medicine. Though the study was small, its impact on biopharma has been huge. The study enrolled five patients with systemic lupus erythematosus (SLE), a chronic autoimmune condition where the immune system targets the patient’s own body. SLE triggers inflammation in organs across the body and can manifest as a wide variety of symptoms, including fevers, blood clots, swollen extremities, fatigue and mouth sores. There is currently no cure for SLE, but the Nature Medicine paper sparked hope that one might be near. The study tested a relatively new technology called CAR T cell therapy, which often uses a patient’s own immune T cells, modifying them outside of the body to make them more potent against certain target cells and then injecting them back into the patient. This approach has already seen success in cancer, with several therapies having earned the FDA’s approval: Gilead’s Yescarta, Johnson & Johnson’s Carvykti and Novartis’ Kymriah, to name a few. The Nature Medicine study hinted at similar promise in autoimmune diseases—all five treated patients hit and maintained remission for an average of eight months and no longer needed other treatments to keep SLE at bay. Two years later, the New England Journal of Medicine published a slightly larger study —including 15 patients—that confirmed these findings and pointed to even broader benefits. CAR T therapy not only elicited remission in SLE patients but also resulted in encouraging response rates in those with idiopathic inflammatory myositis or systemic sclerosis. “Cell therapies are the only modality that appear to provide a prolonged period of drug-free remission, which can be transformative for [a] patient’s quality of life,” Sami Corwin, an analyst at William Blair, told BioSpace in an email. The CAR T approach, in particular, offers a one-time treatment option and is “not associated with chronic side-effects,” as compared with other modalities, Corwin added. Though T cell engagers and NK cells are also being eyed as autoimmune treatments, CAR T therapies are leading the charge—for good reason. “CAR T therapies have already demonstrated remarkable success in conditions like lupus and systemic sclerosis by selectively depleting autoreactive B cells, resulting in sustained immune reset,” Katy Rezvani, head of the Institute for Cell Therapy Discovery & Innovation at MD Anderson, told BioSpace in an email. The biopharma industry is now seeking to expand on this early success, with Bristol Myers Squibb, Kyverna, CRISPR Therapeutics and more progressing CAR T therapies in a wide range of indications, including SLE, multiple sclerosis and stiff person syndrome. Here, BioSpace reviews five of the most advanced players in this space and how they’re harnessing—and innovating on—CAR T technology to address autoimmune diseases. BMS Brings CAR T Cancer Expertise to SLE A leader in CAR T therapies for cancer, Bristol Myers Squibb is now leveraging its cell therapy expertise to address autoimmune diseases. The pharma is working on CD19 NEX-T , an investigational CAR T therapy designed to seek out the cell surface protein CD19, which is highly expressed in B cells. Once it binds to CD19, the CAR T construct activates, releasing a cocktail of inflammatory cytokines and other chemicals that destroy the target B cell. This approach is similar to how BMS’ CAR T therapy Breyanzi works—only this time, the pharma is using this mode of action not to kill cancerous B cells in lymphomas but to deplete defective immune cells that mistakenly attack healthy cells. In an email interview with BioSpace , Rosanna Ricafort, vice president and head of late development, hematology and cell therapy at BMS, called CD19 NEX-T a “top priority” for the pharma, with which it plans to “push the boundaries in immune-mediated diseases.” In service of this goal, the pharma is running the Phase I Breakfree-1 and Breakfree-2 studies of CD19 NEX-T in SLE. At the 66th Annual Meeting of the American Society of Hematology in December 2024, BMS presented early data from both trials showing that three patients followed for at least six months were able to stop all other therapies without showing new signs of disease activity. One patient hit the definition of disease remission at six months. Aside from SLE, BMS is also advancing CD19 NEX-T for multiple sclerosis (MS), for which it unveiled early data last month, pointing to encouraging safety and tolerability. The pharma expects to provide additional early-stage data from the Phase I CD19 NEX-T program this year, building up to pivotal trials as soon as the data allow. “Our ultimate goal is to target the root cause of disease and drive long-term, treatment-free disease control for patients with severe forms of these autoimmune diseases,” Ricafort said. Kyverna Targets First CAR T Therapy for Stiff Person Syndrome This year, Kyverna Therapeutics is anticipating several key milestones for its investigational CAR T therapy KYV-101. Like BMS, Kyverna’s approach targets CD19 to eliminate dysfunctional immune cells, leading to what the biotech calls an “ immune reset ” in patients with autoimmune diseases. KYV-101 is unique in that it is designed specifically to avoid cytokine release syndrome and improve tolerability. Kyverna is testing KYV-101 for three target conditions : Stiff person syndrome (SPS), myasthenia gravis and lupus nephritis. Of these, the most mature indication is SPS, for which Kyverna expects to complete enrollment of a Phase II trial by mid-2025, building up to a topline readout in early 2026, CEO Warner Biddle told BioSpace in an email. Typically afflicting women more than men—and more frequently diagnosed in people 20 to 60 years of age—SPS is a rare disorder that arises when the body makes antibodies that attack the enzyme glutamic acid decarboxylase, which plays a role in the production of a neurotransmitter involved in muscle control. Common symptoms include muscle stiffness and painful spasms. If all goes well for Kyverna this year, the biotech expects to file a Biologics License Application for KYV-101 for SPS next year. “We believe this focused approach in SPS will enable us to deliver the first CAR T cell therapy in autoimmune disease to the market,” Biddle said. Beyond SPS, Kyverna is also looking forward to several catalysts in myasthenia gravis this year, including aligning with the FDA on a registrational path for the CAR T therapy in the first half of 2025, followed by a topline mid-stage readout in the latter half of the year. Kyverna’s autoimmune CAR T program is comprehensive, with the company having treated the most patients with a CAR T cell therapy so far, according to Biddle. CRISPR Homes in on Off-the-Shelf CAR T Market Seeking to build on the momentum from its Vertex Pharmaceuticals–partnered gene therapy Casgevy, CRISPR Therapeutics is now moving its allogeneic next-generation CAR T therapy CTX112 through clinical trials in various autoimmune diseases. The key advantage for CTX112 is its off-the-shelf availability, CRISPR Therapeutics Chief Medical Officer Naimish Patel told BioSpace in an email. “The drawbacks of autologous CAR T cell therapies”—those that draw cells from the patients themselves—“are that they are very expensive, require patients to stop their immunomodulatory therapy to get T cells harvested, are not widely available … and are associated with potentially severe side effects.” CRISPR Therapeutics is evaluating the potential of CTX112 in various autoimmune diseases, supported by safety, pharmacokinetic and pharmacodynamic data from cancer studies. The asset is currently in Phase I development for SLE, but at the 43rd J.P. Morgan Healthcare Conference in January, CEO Samarth Kulkarni bared the company’s plans to expand testing to other autoimmune indications. In its fourth-quarter and full-year 2024 business report last month, CRISPR Therapeutics revealed it had expanded its basket trial for CTX112 to include systemic sclerosis and inflammatory myositis. Updates for study are expected mid-2025, as per the biotech. “We see incredible potential for our allogeneic CAR T program, and we are looking forward to sharing a broad program update on CTX112 mid-year 2025,” Patel said. Autolus Awaits Q1 SLE Readout for Obe-Cel The only therapy on this list with an FDA approval under its belt is Autolus Therapeutics’ obecabtagene autoleucel, also called obe-cel, which was cleared by the regulator in November 2024 for relapsed/refractory B cell acute lymphoblastic leukemia. In this indication, obe-cel is marketed as Aucatzyl. Like most of the other assets in this class, obe-cel targets the CD19 epitope. Autolus is seeking to set its candidate apart from the rest of the space through a unique CAR construct that has what it calls a “ fast-off ” kinetic mechanism, which, unlike the traditional approach, enables the controlled binding of the CAR molecule to its target, in turn activating T cells in a similarly controlled manner. According to Autolus, this fast-off scheme closely mirrors the physiological interactions of T cells with their corresponding receptors. Results from a Phase Ib/II study of obe-cel in B-cell acute lymphoblastic leukemia, published in the New England Journal of Medicine in November 2024, suggest that Autolus’ fast-off approach improves T cell persistence and lowers exhaustion, leading to better clinical outcomes. More than half of patients achieved complete remission after obe-cel treatment, with an estimated 12-month overall survival rate of 61.1% Autolus still doesn’t have such detailed data for obe-cel in autoimmune diseases. The biotech is currently running the Phase I CARLYSLE study in advanced SLE, for which initial data are expected in the first quarter of this year, as per a November 2024 company presentation . Cabaletta Anticipates Multiple Catalysts for Rese-Cel in 2025 Cabaletta Bio—which launched in November 2018 with a stated focus on autoimmune disease—was ahead of the curve in this space. It is also the only company on this list that is developing its investigational cell therapy exclusively for autoimmune diseases. CABA-201 , also called resecabtagene autoleucel or rese-cel, is an investigational CAR T therapy that also targets CD19. What makes rese-cel unique is that it contains a 4-1BB domain, which is a protein commonly expressed on activated T cells that helps enhance their activity . Recent preclinical evidence has pointed to the potential of targeting 4-1BB to address autoimmune diseases. Cabaletta is testing this approach in the clinic with its Phase I/II RESET program, which is assessing rese-cel in a wide variety of autoimmune disorders, including myositis, SLE, systemic sclerosis, myasthenia gravis, MS and pemphigus vulgaris. Of these indications, the biotech named as primary focuses myositis, SLE and systemic sclerosis, for which rese-cel’s mechanism has the potential to “achieve robust improvement in clinical disease activity within 3 months of treatment,” according to its website . In a corporate presentation last month, Cabaletta unveiled initial clinical data from the RESET program, touting “consistent and deep” depletion of B cells 22 days after infusion. Additionally, treatment with rese-cel resulted in strong treatment response, pointing to the potential to achieve drug-free remission in patients with refractory disease. Similarly, rese-cel showed the potential of a “drug-free clinical response” in systemic sclerosis, while early data for SLE pointed to promising rates of remission. Cabaletta has several other rese-cel milestones lined up for 2025 , including more clinical and translational readouts throughout the year and a meeting with the FDA to align on a registrational path for the asset.

Phase 1 clinical trial of ADI-001 in autoimmune diseases ongoing; on track to report preliminary clinical data from lupus nephritis (LN) patient cohort in 1H25 Additional LN clinical data and preliminary clinical data from other autoimmune patient cohorts anticipated in 2H25 Initiation of ADI-001 Phase 1 clinical trial patient enrollment in systemic lupus erythematosus (SLE), systemic sclerosis (SSc), idiopathic inflammatory myopathy (IIM) and stiff person syndrome (SPS) expected in 2Q25; anti-neutrophil cytoplasmic autoantibody (ANCA) associated vasculitis (AAV) patient enrollment expected to be initiated in 2H25 Advancing patient enrollment in ADI-270 Phase 1 clinical trial in patients with metastatic/advanced clear cell renal cell carcinoma (ccRCC); plan to report preliminary data in 1H25 $176.3 million in cash, cash equivalents and short-term investments as of December 31, 2024 REDWOOD CITY, Calif. & BOSTON--(BUSINESS WIRE)--Mar. 6, 2025-- Adicet Bio, Inc. (Nasdaq: ACET), a clinical stage biotechnology company discovering and developing allogeneic gamma delta T cell therapies for autoimmune diseases and cancer, today reported financial results and operational highlights for the fourth quarter and year ended December 31, 2024. “In 2025 we plan to continue advancing our gamma delta 1 CAR T cell therapy programs, achieving key milestones and reporting preliminary data in autoimmune and oncology indications,” said Chen Schor, President and Chief Executive Officer of Adicet Bio. “The recent FDA Fast Track Designation for ADI-001 in refractory SLE with extrarenal involvement and in SSc highlights the significant unmet need for innovative, off-the-shelf therapies to treat autoimmune diseases. We are continuing to enroll LN patients in our ongoing Phase 1 trial in autoimmune diseases and look forward to sharing preliminary clinical data in the first half of 2025 and additional data in the second half of 2025. We expect to initiate enrollment for SLE, SSc, IIM and SPS patients in the second quarter and for AAV in the second half of the year, and to report clinical data from these additional cohorts in the second half as well.” Mr. Schor continued: “In addition, we are continuing to enroll patients in our Phase 1 trial of ADI-270 in relapsed or refractory metastatic/advanced ccRCC patients and remain on track to announce preliminary clinical data in the first half of 2025. With a strong clinical foundation and growing momentum, Adicet is well-positioned to transform treatment paradigms for patients battling autoimmune diseases and solid tumors.” Fourth Quarter 2024 and Recent Operational Highlights: Autoimmune diseases Continuing to advance phase 1 trial of ADI-001 in autoimmune diseases. In November 2024, Adicet announced the dosing of the first patient in the Phase 1 trial evaluating ADI-001 in LN. Enrollment for SLE, SSc, IIM, and SPS patients is expected to commence in the second quarter of 2025, with the initiation of AAV patient enrollment anticipated in the second half of 2025. The Company remains on track to share preliminary clinical data from the trial’s LN cohort in the first half of 2025. Additional LN clinical data and preliminary clinical data from other autoimmune patient cohorts are anticipated in the second half of 2025, subject to study site initiation and patient enrollment. Fast Track Designation for ADI-001. In February 2025, Adicet received Fast Track Designation for ADI-001 for the treatment of refractory SLE with extrarenal involvement and SSc. ADI-001 clinical biomarker data presented at the American College of Rheumatology (ACR) Convergence 2024. In November 2024, Adicet showcased an oral abstract at the ACR Convergence 2024 detailing ADI-001 clinical biomarker data. The findings demonstrated significant chimeric antigen receptor (CAR) T cell activation, robust tissue trafficking and complete CD19+ B cell depletion in secondary lymphoid tissue, underscoring ADI-001's potential as a best-in-class off-the-shelf cell therapy for autoimmune diseases. Solid tumor indications First patient dosed in phase 1 trial of ADI-270 in metastatic/advanced ccRCC. In December 2024, Adicet announced the dosing of the first patient in the Phase 1 clinical trial evaluating the safety and efficacy of ADI-270 in adults with relapsed or refractory metastatic/advanced ccRCC. Preliminary clinical data from the trial are anticipated in the first half of 2025. Presentation of ADI-270 data at the Society for Immunotherapy of Cancer (SITC) 2025 Spring Scientific Meeting. In March 2025, Adicet will present two posters highlighting ADI-270 preclinical data at the SITC 2025 Spring Scientific Meeting taking place March 12-14 in San Diego, CA. Corporate updates Appointed Julie Maltzman, M.D., as Chief Medical Officer. In December 2024, Adicet appointed Julie Maltzman, M.D., as Chief Medical Officer, who brings over two decades of experience in clinical development and regulatory affairs to the Company's leadership team. Dr. Maltzman’s expertise spans across oncology and autoimmune diseases, encompassing all phases of drug development from early-stage research to global regulatory approvals and commercialization. Dr. Maltzman is leading Adicet’s clinical development functions to advance the company's pipeline of allogeneic gamma delta CAR T cell therapies. Financial Results for Fourth Quarter and Full Year 2024: Three months ended December 31, 2024 Research and Development (R&D) Expenses: R&D expenses were $23.3 million for the three months ended December 31, 2024, compared to $24.8 million during the same period in 2023. The decrease in R&D expenses was primarily due to a $1.3 million decrease in expenses related to contract development and manufacturing organizations (CDMOs). General and Administrative (G&A) Expenses: G&A expenses were $7.5 million for the three months ended December 31, 2024, compared to $6.8 million during the same period in 2023. The increase in general and administrative expenses was primarily due to a $0.5 million increase in professional fees. Net Loss: Net loss for the three months ended December 31, 2024 was $28.7 million, or a net loss of $0.32 per basic and diluted share, including non-cash stock-based compensation expense of $3.8 million, as compared to a net loss of $29.5 million, or a net loss of $0.69 per basic and diluted share, including non-cash stock-based compensation expense of $4.9 million during the same period in 2023. Twelve Months Ended December 31, 2024 Research and Development (R&D) Expenses: R&D expenses were $99.3 million for the year ended December 31, 2024, compared to $106.0 million for the year ended December 31, 2023. The $6.7 million decrease was primarily driven by a $7.7 million decrease in expenses related to CDMOs. This decrease was partially offset by a $0.6 million increase in lab expenses as well as a $0.5 million increase in professional fees. General and Administrative (G&A) Expenses: G&A expenses were $28.3 million for the year ended December 31, 2024, compared to $26.5 million for the year ended December 31, 2023. The $1.8 million increase was primarily driven by a $0.9 million increase in professional fees for the period. There was also a net $0.4 million increase in payroll and personnel expenses and a $0.3 million increase in depreciation expense for the period. Net Loss: Net loss for the year ended December 31, 2024 was $117.1 million, or a net loss of $1.33 per basic and diluted share, including non-cash stock-based compensation expense of $22.2 million, as compared to a net loss of $142.7 million, or a net loss of $3.31 per basic and diluted share, including non-cash stock-based compensation expense of $20.3 million during the same period in 2023. Cash Position: Cash, cash equivalents and short-term investments were $176.3 million as of December 31, 2024, compared to $159.7 million as of December 31, 2023. The Company expects that current cash, cash equivalents and short-term investments as of December 31, 2024, will be sufficient to fund its operating expenses into the second half of 2026. About Adicet Bio, Inc. Adicet Bio, Inc. is a clinical stage biotechnology company discovering and developing allogeneic gamma delta T cell therapies for autoimmune diseases and cancer. Adicet is advancing a pipeline of “off-the-shelf” gamma delta T cells, engineered with chimeric antigen receptors (CARs), to facilitate durable activity in patients. For more information, please visit our website at https://www.adicetbio.com. Forward-Looking Statements This press release contains “forward-looking statements” of Adicet within the meaning of the Private Securities Litigation Reform Act of 1995 relating to the business and operations of Adicet. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These forward-looking statements include, but are not limited to, express or implied statements regarding: clinical development of Adicet’s product candidates, including future plans or expectations for ADI-001 in autoimmune diseases and ADI-270 in ccRCC and the potential safety, tolerability and efficacy for the treatment of autoimmune diseases and cancer; ADI-001’s potential to be an off-the-shelf treatment option for autoimmune indications; ADI-270’s potential to be the first gamma delta CAR T cell therapy to address solid tumors; timing and success of the Phase 1 clinical trial of ADI-001 in LN, SLE, SSc, AAV, IIM and SPS, including timing and expectations for enrollment and future data releases; timing and success of the Phase 1 clinical trial of ADI-270 in ccRCC, including expectations for future data releases; and expectations regarding Adicet’s uses of capital, expenses and financial results, including the expected cash runway. Any forward-looking statements in this press release are based on management’s current expectations and beliefs of future events, and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements, including without limitation, the effect of global economic conditions and public health emergencies on Adicet’s business and financial results, including with respect to disruptions to our preclinical and clinical studies, business operations, employee hiring and retention, and ability to raise additional capital; Adicet’s ability to execute on its strategy including obtaining the requisite regulatory approvals on the expected timeline, if at all; that positive results, including interim results, from a preclinical or clinical study may not necessarily be predictive of the results of future or ongoing studies; clinical studies may fail to demonstrate adequate safety and efficacy of Adicet’s product candidates, which would prevent, delay, or limit the scope of regulatory approval and commercialization; and regulatory approval processes of the U.S. Food and Drug Administration and comparable foreign regulatory authorities are lengthy, time-consuming, and inherently unpredictable; and Adicet’s ability to meet production and product release expectations. For a discussion of these and other risks and uncertainties, and other important factors, any of which could cause Adicet’s actual results to differ from those contained in the forward-looking statements, see the section titled “Risk Factors” in Adicet’s most recent annual report on Form 10-K, as well as discussions of potential risks, uncertainties, and other important factors in Adicet’s other filings with the U.S. Securities and Exchange Commission, including its quarterly report on Form 10-Q. All information in this press release is as of the date of the release, and Adicet undertakes no duty to update this information unless required by law. ADICET BIO, INC. Consolidated Statements of Operations and Comprehensive Income (in thousands, except share and per share amounts) Three Months Ended December 31, Years Ended December 31, 2024 2023 2024 2023 Operating expenses: Research and development $ 23,273 $ 24,759 $ 99,323 $ 106,043 General and administrative 7,470 6,807 28,292 26,533 Goodwill impairment — — — 19,462 Total operating expenses 30,743 31,566 127,615 152,038 Loss from operations (30,743 ) (31,566 ) (127,615 ) (152,038 ) Interest income 2,067 2,178 10,714 9,978 Interest expense (1 ) — (4 ) (25 ) Other expense, net (50 ) (101 ) (217 ) (573 ) Loss before income tax provision (28,727 ) (29,489 ) (117,122 ) (142,658 ) Income tax provision — — — — Net loss $ (28,727 ) $ (29,489 ) $ (117,122 ) $ (142,658 ) Net loss per share, basic and diluted $ (0.32 ) $ (0.69 ) $ (1.33 ) $ (3.31 ) Weighted-average common shares used in computing net loss per share, basic and diluted 90,846,293 43,035,315 87,866,435 43,042,405 Other comprehensive income Unrealized (loss) gain on treasury securities, net of tax (105 ) — 16 — Total other comprehensive income (105 ) — 16 — Comprehensive loss $ (28,832 ) $ (29,489 ) $ (117,106 ) $ (142,658 ) ADICET BIO, INC. Consolidated Balance Sheets Information (in thousands) December 31, December 31, 2024 2023 Cash, cash equivalents and short-term investments in treasury securities $ 176,303 $ 159,711 Working capital 160,744 142,985 Total assets 220,219 207,295 Accumulated deficit (497,894 ) (380,772 ) Total stockholders’ equity 186,609 170,175 View source version on businesswire.com: https://www.businesswire.com/news/home/20250306092267/en/ Adicet Bio, Inc. Investor and Media Contacts Investors: Anne Bowdidge abowdidge@adicetbio.com Janhavi Mohite Precision AQ 212-362-1200 janhavi.mohite@precisionaq.com Media: Kerry Beth Daly kbdaly@adicetbio.com Source: Adicet Bio, Inc.