Ankündigung • May 02
Adicet Bio, Inc., Annual General Meeting, Jun 17, 2026 Adicet Bio, Inc., Annual General Meeting, Jun 17, 2026. Ankündigung • Jan 08
Adicet Bio, Inc. Announces That Enrollment in Its Prulacabtagene Leucel (Prula-Cel, Formerly Adi-001) Phase 1 Program in Autoimmune Diseases Has Doubled to over 20 Patients On January 7, 2026, Adicet Bio, Inc. announced that enrollment in its prulacabtagene leucel (prula-cel, formerly ADI-001) Phase 1 program in autoimmune diseases has doubled to over 20 patients as of December 31, 2025. The Company also reached alignment with the U.S. Food and Drug Administration (FDA) to allow patients with lupus nephritis and systemic lupus erythematosus to be dosed with prula-cel in the outpatient setting in ongoing and future clinical trials. The Company plans to request a meeting with the FDA in the second quarter of 2026 to inform potential Phase 2 pivotal trial design for prula-cel. Ankündigung • Oct 16
Adicet Bio, Inc. Announces First Patient Dosed in Phase 1 Clinical Trial of ADI-001 in Treatment-Refractory Rheumatoid Arthritis Adicet Bio, Inc. announced that the first patient has been dosed in its Phase 1 clinical trial evaluating ADI-001 in treatment-refractory RA. The Phase 1 program is evaluating ADI-001 across seven different autoimmune diseases including: lupus nephritis (LN), systemic lupus erythematosus (SLE), systemic sclerosis (SSc), idiopathic inflammatory myopathy (IIM), stiffness person syndrome (SPS), anti-neutrophil cytoplasmic autoantibody (ANCA) associated vasculitis (AAV) and RA. ADI-001 was granted Fast Track Designation by the U.S. Food and Drug Administration for the potential treatment of relapsed/refractory class III or class IV LN, refractory SLE with extrarenal involvement, and SSc. The Phase 1 study in RA testing ADI-001 using two different conditioning regimens is in the context of a broader initiative at Adicet that seeks to deliver a best-in-class portfolio of therapies for autoimmune patients. This initiative includes additional ongoing preclinical programs, including gene-edited CAR T and in vivo CAR T programs targeting B cells with the potential for reducing or eliminating the need for conditioning. Ankündigung • Oct 08
Adicet Bio, Inc. Receives Notice of Nasdaq Listing Transfer and Extension to Regain Bid Price Compliance As previously reported on April 7, 2025, Adicet Bio, Inc. received a notification letter (the Bid Price Letter) from The Nasdaq Stock Market LLC (Nasdaq) notifying the Company that, for the last 30 consecutive business days, the closing bid price for the Company’s common stock, par value $0.0001 per share (the Common Stock), has been below the minimum $1.00 per share required (the Bid Price Requirement) for continued listing on the Nasdaq Global Market pursuant to Nasdaq Listing Rule 5450(a)(1). In accordance with Nasdaq Listing Rule 5810(c)(3)(A), the Company was given 180 calendar days, or until October 6, 2025, to regain compliance with the Bid Price Requirement pursuant to Nasdaq Listing Rule 5450(a)(1). On October 7, 2025, the Company received a notice (the Extension Notice) from Nasdaq informing the Company that Nasdaq has granted the Company an additional 180 calendar days, or until April 6, 2026, to regain compliance with the Bid Price Requirement for continued listing on the Nasdaq Capital Market under Nasdaq Listing Rule 5550(a)(2). In connection with the Extension Notice, the listing of the Common Stock will be transferred from the Nasdaq Global Market to the Nasdaq Capital Market, effective at the opening of business on October 9, 2025. The Extension Notice has no other immediate effect on the listing of the Common Stock. The Company intends to continue actively monitor the bid price for its Common Stock between now and April 6, 2026, and will consider available options to resolve the deficiency and regain compliance with the Bid Price Requirement. These options include, but are not limited to, effecting a reverse stock split, if necessary, to attempt to regain compliance. If at any time before April 6, 2026, the closing bid price of the Common Stock is at least $1.00 per share for a minimum of 10 consecutive business days, Nasdaq will provide written confirmation that the Company has regained compliance with the Bid Price Requirement. If the Company does not regain compliance within the additional compliance period, Nasdaq will provide notice that the Common Stock will be subject to delisting. The Company would then be entitled to appeal that determination to a Nasdaq hearings panel. There is no assurance, however, that the Company will regain compliance with the Bid Price Requirement or that the Common Stock will not be delisted from Nasdaq. Ankündigung • Jul 24
Adicet Bio, Inc. Announces First Systemic Sclerosis (Ssc) Patient Dosed in Ongoing Phase 1 Clinical Trial of Adi-001 in Autoimmune Diseases Adicet Bio, Inc. announced that the first systemic sclerosis (SSc) patient has been dosed in the second cohort of the Phase 1 clinical trial evaluating ADI-001 in autoimmune diseases. ADI-001 is an investigational allogeneic gamma delta chimeric antigen receptor (CAR) T cell therapy targeting B-cells via an anti-CD20 CAR. ADI-001 was granted Fast Track Designation by the U.S. Food and Drug Administration (FDA) for the potential treatment of relapsed/refractory class III or class IV lupus nephritis (LN), refractory systemic lupus erythematosus (SLE) with extrarenal involvement and systemic sclerosis (SSc). Ankündigung • May 11
Adicet Bio, Inc. to Report Q1, 2025 Results on May 06, 2025 Adicet Bio, Inc. announced that they will report Q1, 2025 results on May 06, 2025 Ankündigung • May 01
Adicet Bio, Inc., Annual General Meeting, Jun 11, 2025 Adicet Bio, Inc., Annual General Meeting, Jun 11, 2025. Ankündigung • Apr 13
Adicet Bio Receives Non-Compliance Letter from Nasdaq Regarding Bid Price Rule On April 7, 2025, Adicet Bio, Inc. (the Company") received a notice from the Listing Qualifications staff (the Staff") of the Nasdaq Stock Market LLC (Nasdaq") that because the closing bid price for the Company's common stock had fallen below $1.00 per share for 30 consecutive business days, the Company no longer complied with the minimum bid price requirement for continued listing on the Nasdaq Global Market under Nasdaq Listing Rule 5450(a)(1) (the Bid Price Rule"). The letter does not result in the immediate delisting of the Company's Common Stock, and the Company's Common Stock will continue to trade uninterrupted on the Nasdaq Global Market under the symbol ACET." Pursuant to Nasdaq Listing Rule 5810(c)(3)(A), the Company had been provided an initial compliance period of 180 calendar days, or until October 6, 2025 (the Compliance Date"), to regain compliance with the Bid Price Rule. To regain compliance, the closing bid price of the Company's common stock must meet or exceed $1.00 per share for a minimum of 10 consecutive business days prior to the Compliance Date. The Staff has the discretion to require the Company to maintain the minimum bid price for a period in excess of 10 consecutive business days, but generally no more than 20 consecutive business days, pursuant to Nasdaq Listing Rule 5810(c)(3)(H). If the Company is unable to regain compliance before the Compliance Date, the Company may be eligible for an additional 180 calendar days to satisfy the Bid Price Rule. To qualify, the Company will be required to meet the continued listing requirement for market value of publicly held shares and all other initial listing standards for the Nasdaq Capital Market with the exception of the Bid Price Rule, and will need to provide written notice of its intention to cure the deficiency during such additional compliance period, by effecting a reverse stock split, if necessary. If it appears to the Staff that the Company will not be able to cure the deficiency, or if the Company is otherwise not eligible for the additional compliance period, and the Company does not regain compliance by the Compliance Date, Nasdaq will provide written notification to the Company that its common stock is subject to delisting. At that time, the Company may appeal the delisting determination to a hearings panel pursuant to the procedures set in the applicable Nasdaq Listing Rules. However, there can be no assurance that, if the Company does appeal the delisting determination by Nasdaq to the panel, such appeal would be successful. The Company intends to monitor the closing bid price of its common stock and will take all reasonable measures available to the Company to regain compliance with the Bid Price Rule, including potentially seeking to effect a reverse stock split. There can be no assurance that the Company will be able to regain compliance for continued listing on Nasdaq or will otherwise be in compliance with other Nasdaq listing criteria and that the Company will be able to maintain its listing with Nasdaq. Ankündigung • Mar 08
Adicet Bio, Inc. Plans to Continue Advancing Gamma Delta 1 Car T Cell Therapy Programs Adicet Bio, Inc. announced in 2025, planned to continue advancing gamma delta 1 CAR T cell therapy programs, achieving key milestones and reporting preliminary data in autoimmune and oncology indications. 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. The company is continuing to enroll LN patients in 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. The company is expected 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. Ankündigung • Feb 28
Adicet Bio, Inc. Receives FDA Fast Track Designation for ADI-001 for the Treatment of Systemic Sclerosis Adicet Bio, Inc. announced the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to ADI-001 for the potential treatment of adult patients with systemic sclerosis (SSc). Fast Track Designation is a process designed to facilitate development and expedite the review of drugs intended to treat serious conditions and fill an unmet medical need. ADI-001 is aninvestigational allogeneic gamma delta chimeric antigen receptor (CAR) T cell therapy targeting CD20 for the treatment of autoimmune diseases. ADI-001 has been granted Fast Track Designation by the FDA for the treatment of relapsed/refractory class III or class IV lupus nephritis (LN), systemic lupus erythematosus (SLE) with extrarenal involvement and systemic sclerosis (SSc). The Company is advancing ADI-001 across six autoimmune indications. Patient enrollment is ongoing in the Phase 1 study evaluating ADI-001 for the treatment of LN. Patient enrollment in SLE, SSc, idiopathic inflammatory myopathy (IIM, or myositis), and stiff person syndrome (SPS) is expected to be initiated in the second quarter of 2025. Initiation of enrollment in anti-neutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis (AAV) is expected in the second half of 2025. In the Phase 1 GLEAN trial, ADI-001 was shown to target B-cells via an anti-CD20 CAR and demonstrated robust exposure and complete CD19+ B-cell depletion both in blood and secondary lymphoid tissue. Ankündigung • Feb 06
Adicet Bio, Inc. Receives FDA Fast Track Designation for ADI-001 for the Treatment of Refractory Systemic Lupus Erythematosus (SLE) with Extrarenal Involvement Adicet Bio, Inc. announced the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to ADI-001 for the potential treatment of adult patients with refractory systemic lupus erythematosus (SLE) with extrarenal involvement. Fast Track Designation is a process designed to facilitate development and expedite the review of drugs intended to treat serious conditions and fill an unmet medical need. ADI-001 is aninvestigational allogeneic gamma delta chimeric antigen receptor (CAR) T cell therapy targeting CD20 for the treatment of autoimmune diseases. ADI-001 was granted Fast Track Designation by the FDA for the treatment of relapsed/refractory class III or class IV lupus nephritis (LN), and SLE with extrarenal involvement. The Company is advancing ADI-001 across six autoimmune indications. Patient enrollment is ongoing in the Phase 1 study evaluating ADI-001 for the treatment of LN. Patient enrollment in SLE, systemic sclerosis (SSc), idiopathic inflammatory myopathy (IIM, or myositis), and stiff person syndrome (SPS) is expected to be initiated in the first quarter of 2025. Initiation of enrollment in anti-neutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis (AAV) is expected in the second half of 2025. In the Phase 1 GLEAN trial, ADI-001 was shown to target B-cells via an anti-CD20 CAR and demonstrated robust exposure and complete CD19+ B-cell depletion both in peripheral blood and secondary lymphoid tissue. Ankündigung • Dec 19
Adicet Bio, Inc. Announces First Patient Dosed in the Phase 1 Clinical Trial of ADI-270 in Metastatic/Advanced Clear Cell Renal Cell Carcinoma Adicet Bio, Inc. announced that the first patient has been dosed in the Phase 1 clinical trial evaluating ADI-270 in patients with metastatic/advanced ccRCC. The Phase 1 multicenter, open-label clinical trial is designed to investigate ADI-270 as monotherapy in adults with relapsed or refractory metastatic/advanced ccRCC. The Phase 1 multicenter, open-label clinical trial is designed to investigate ADI-270 as monotherapy in adults with relapsed or refractory metastatic/advanced ccRCC. Following lymphodepletion, patients will be eligible to receive a single dose of ADI-270 with a starting dose level of 3E8 CAR+ cells. Subject to meeting protocol defined criteria, patients enrolled in the trial may be eligible to receive a second dose of ADI-270. The dose escalation and dose expansion portions of the trial will evaluate safety, tolerability, and pharmacokinetics as well as anti-tumor activity as assessed by overall response rate, duration of response and disease control rate. ADI-270 is an armored allogeneic “off-the-shelf” gamma delta CAR T cell therapy candidate targeting CD70-positive cancers. CD70 is a compelling target due to its high expression in both solid and hematological malignancies. ADI-270 is engineered with a third-generation CAR designed to target CD70 using its natural receptor, CD27, as the binding moiety and is further armored with a dominant negative form of the transforming growth factor-ß receptor II (dnTGFßRII) to provide functional resilience to the immunosuppressive tumor microenvironment. ADI-270 is also designed to increase exposure and persistence by reducing susceptibility to host vs. graft elimination. These properties of ADI-270 combined with the potent tumor infiltration demonstrated with gamma delta 1 T cells aim to improve clinical responses of RCC patients and other patients with CD70+ tumors. Renal cell carcinoma (RCC) is the most common tumor of the kidney, constituting 80% to 85% of primary renal neoplasms. Clear cell RCC (ccRCC) is the most common subtype, accounting for 80% of all RCCs. ccRCC is an aggressive subtype arising from renal stem cells commonly arising in the proximal nephron and tubular epithelium, and often metastasizes to the lungs, liver, and bones. Approximately 20% of newly diagnosed cases of RCC are locally advanced or metastatic and up to 30% of patients will develop metastatic disease following nephrectomy. While the 5-year survival rate for localized RCC is 93%, the 5-year survival rate for advanced disease is 15%. Ankündigung • Dec 18
Adicet Bio, Inc. Announces Executive Changes Adicet Bio, Inc. announced the appointment of Julie Maltzman, M.D. as Chief Medical Officer, effective January 13, 2025. Dr. Maltzman will lead the Adicet clinical development strategy to advance Adicet’s robust autoimmune and oncology pipeline. Dr. Maltzman succeeds Dr. Francesco Galimi who has completed his tenure at Adicet this month. Dr. Maltzman has broad experience, built over 20 years, leading clinical development efforts both in oncology and autoimmune diseases across all phases of drug development, from early Phase 1 through global regulatory filings, approvals and commercialization. She joins Adicet from IconOVir Bio where she served as Chief Medical Officer leading, designing, and executing on a clinical development program focused on refractory solid tumors. Prior to that, she served as the VP, Global Head of GI Cancers and Cancer Immunotherapy at Roche/Genentech. There, Dr. Maltzman oversaw the successful worldwide registration and commercialization of the solid tumor blockbuster combination therapy Tecentriq+Avastin and co-led the cross-functional team accountable for managing all Tecentriq program activities including manufacturing, safety, biomarker and translational research, regulatory strategy, branding and positioning. Dr. Maltzman also served as the executive Co-Chair of their multifunctional, senior-level integrated Cancer Immunotherapy Committee (CITC) which brought together all key functions to articulate an integrated Roche Group Cancer Immunotherapy Strategic roadmap. Dr. Maltzman led early First-In-Human trials for rheumatoid arthritis with novel monoclonal antibodies while at Morphotek Inc. With additional leadership roles at flagship biopharma companies including Gilead and Glaxo SmithKline (GSK), Dr. Maltzman has designed and efficiently implemented clinical studies exceeding enrollment goals months earlier than anticipated, assisted with CMC (Chemistry, Manufacturing and Controls) initiatives to support clinical and regulatory submissions, conceptualized and negotiated multiple U.S. and EU labels, and established and built Medical and Medical Affairs functions including activating key opinion leader (KOL) and scientific educational initiatives to drive therapeutic awareness and adoption. Dr. Maltzman earned her M.D. from the University of Colorado, completed her Internship and Residency in the Department of Internal Medicine at the University of Chicago, and completed a Fellowship in the Division of Hematology/Oncology at the University of Pennsylvania. Ankündigung • Nov 16
Adicet Bio, Inc. Presents Clinical Biomarker Data for Off-the-Shelf CAR T Cell Therapy in an Oral Session at the American College of Rheumatology (ACR) Convergence 2024 Adicet Bio, Inc. announced that clinical biomarker data from the ADI-001 Phase 1 GLEAN trial which demonstrates robust tissue homing, significant CAR T cell activation, and complete CD19+ B cell depletion in secondary lymphoid tissue will be featured in an oral session at ACR Convergence 2024 in Washington, D.C., November 14-19, 2024. A summary of the results: ADI-001 demonstrated significant levels of CAR T cell activation and tissue exposure in lymph node biopsies in the GLEAN trial, representing a range of 27-64% of total cellular material detected by ddPCR in evaluable biopsies at the 1E9 dose, and exceeding levels previously reported for patients who received autologous alpha-beta CAR T therapies. CAR T cells detected in tissues also demonstrated a robust activation profile, based on in situ levels of granzyme B. Recently published studies have demonstrated depletion of CD19+ plasmablasts, memory B cells and naïve B cells in peripheral blood using anti-CD20 targeted antibodies, however, these CD20-targeted antibody modalities failed to fully deplete B cells within secondary lymphoid tissue. Concurrent with ADI-001 tissue trafficking and activation, complete depletion of CD19+ B cells within analyzed lymph node tissue was also observed. These results support ADI-001’s potential for achieving complete B-cell depletion in peripheral blood and within tissues. The Phase 1 study has four separate arms, enrolling LN and SLE patients into one arm, SSc patients into a second arm, IIM and SPS patients in a third arm and AAV patients into a fourth arm. Enrolled patients will receive a single dose of ADI-001. The dose-limiting toxicity window is 28 days with response and safety assessments conducted on Day 28 and during the follow-up period on months 3, 6, 9, 12, 18 and 24. The primary objectives of the study are to evaluate the safety and tolerability of ADI-001. Secondary objectives include measuring cellular kinetics, pharmacodynamics, changes in autoantibody titers, and appropriate disease activity scores in each indication. Ankündigung • Oct 16
Adicet Bio, Inc Announces FDA Clearance of IND Amendment to Evaluate ADI-001 in Idiopathic Inflammatory Myopathy and Stiff Person Syndrome Adicet Bio, Inc. announced that the U.S. Food and Drug Administration (FDA) has agreed to an amendment to the Company’s Investigational New Drug (IND) application to evaluate ADI-001 in idiopathic inflammatory myopathy (IIM) and stiff person syndrome (SPS) as part of the ongoing Phase 1 trial in autoimmune diseases. The Company plans to initiate enrollment for IIM and SPS patients in the first quarter of 2025. This announcement follows the FDA’s recent agreements on amendments to the Company’s ADI-001 IND application to evaluate three additional indications beyond lupus nephritis (LN), including systemic lupus erythematosus (SLE), systemic sclerosis (SSc) and anti-neutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis (AAV). The ADI-001 Phase 1 program in autoimmune diseases will have four separate arms, enrolling LN and SLE patients into one arm, SSc patients into a second arm, AAV patients into a third arm, and IIM and SPS patients into a fourth arm. The fourth cohort combines several rare autoimmune muscle diseases into a single dose-finding population, including SPS and the following IIM subtypes: dermatomyositis, anti-synthetase syndrome, immune-mediated necrotizing myopathy, polymyositis, and overlap myositis. Enrolled patients will receive a single dose of ADI-001. The dose-limiting toxicity window is 28 days with response and safety assessments conducted on Day 28 and during the follow up period on months 3, 6, 9, 12, 18, and 24. The primary objectives of the study are to evaluate the safety and tolerability of ADI-001. Secondary objectives include measuring cellular kinetics, pharmacodynamics, changes in autoantibody titers, and appropriate disease activity scores in each indication. Ankündigung • Oct 01
Adicet Bio, Inc. Opens Enrollment for ADI-001 Phase 1 Clinical Trial in Autoimmune Diseases Adicet Bio, Inc. announced the opening of enrollment for the Phase 1 clinical trial evaluating ADI-001 in autoimmune diseases. This announcement follows the U.S. Food and Drug Administration’s (FDA) decision to grant Fast Track Designation to ADI-001 for the treatment of relapsed/refractory class III or class IV LN and clearance from the FDA to develop ADI-001 in four autoimmune indications, including LN, SLE, SSc, and AAV. The Phase 1 study has three separate arms, enrolling LN and SLE patients into one arm, SSc patients into a second arm and AAV patients into a third arm. Enrolled patients will receive a single dose of ADI-001. The dose-limiting toxicity window is 28 days with response and safety assessments conducted on Day 28 and during the follow up period on months 3, 6, 9, 12, 18 and 24. The primary objectives of the study are to evaluate the safety and tolerability of ADI-001. Secondary objectives include measuring cellular kinetics, pharmacodynamics, changes in autoantibody titers, and appropriate disease activity scores in each indication. Ankündigung • Sep 19
Adicet Bio, Inc Announces ADI-001 Clinical Biomarker Data from the Phase 1 Glean Trial Which Further Reinforces the Potential of ADI-001 as Best-In-Class Allogeneic Cell Therapy for Autoimmune Diseases Adicet Bio, Inc. announced ADI-001 clinical biomarker data from the Phase 1 GLEAN trial which further reinforces the potential of ADI-001 as a best-in-class allogeneic cell therapy for autoimmune diseases. Notably, ADI-001 demonstrated robust tissue trafficking resulting in high levels of ADI-001, significant chimeric antigen receptor (CAR) T cell activation, and complete CD19+ B cell depletion in secondary lymphoid tissue. These data will be presented by Dr. Blake Aftab, Chief Scientific Officer, at the 9th Annual CAR-TCR Summit on September 19, 2024 in Boston, MA. A summary of the results is reported below: ADI-001 demonstrated significant levels of CAR T cell activation and tissue exposure in lymph node biopsies in the GLEAN trial, with a mean exposure of 236,701 CAR T cells per million across all dose levels, representing a range of 27-64% of total cellular material detected by ddPCR in evaluable biopsies at the 1E9 dose, and exceeding levels previously reported for patients who received autologous alpha-beta CAR T therapies. CAR T cells detected in tissues also demonstrated a robust activation profile, based on in situ detection of granzyme B. Recently published studies have demonstrated depletion of CD19+ plasmablasts, memory B cells and naïve B cells in peripheral blood using anti-CD20 targeted antibodies, however, these CD20-targeted antibody modalities failed to deplete B cells within secondary lymphoid tissues. Concurrent with ADI-001 tissue trafficking and activation, complete depletion of CD19+ B cells within analyzed secondary lymphoid tissue was also observed. These results support ADI-001’s potential for achieving complete B-cell depletion in peripheral blood and within tissues. Adicet is advancing the ADI-001 clinical program in lupus nephritis, systemic lupus erythematosus, systemic sclerosis and anti-neutrophil cytoplasmic autoantibody associated vasculitis (AAV) and expects to report initial clinical data in the first half of 2025. Ankündigung • Sep 10
Adicet Bio, Inc Announces Strategic Prioritization to Focus ADI-001 Development Resources on Autoimmune Indications On September 10, 2024, Adicet Bio, Inc. announced a strategic prioritization to focus ADI-001 development resources on autoimmune indications. The Company is focusing on advancing the clinical development of ADI-001 in four autoimmune indications, which include lupus nephritis, systemic lupus erythematosus, systemic sclerosis and anti-neutrophil cytoplasmic autoantibody associated vasculitis, and expects to further expand ADI-001 clinical development into additional autoimmune indications in the near term. Due to this prioritization, patient enrollment in the Phase 1 clinical study of ADI-001 in mantle cell lymphoma (MCL) has been closed, and topline results are reported below. Across all doses, 10 evaluable patients with MCL that were treated with ADI-001 demonstrated an overall response rate (ORR) of 80% (8/10), a complete response (CR) rate of 60% (6/10), with a median duration of complete response of 17.5 months as of August 22, 2024. Patients were heavily pretreated with a median of 3 prior lines of therapy and 30% of patients had progressed on prior CAR T. In the Phase 1 study, ADI-001 demonstrated a favorable safety and tolerability profile, with no occurrences of graft-versus-host disease and low incidence of grade =3 cytokine release syndrome and neurotoxicity that compared favorably to data reported for autologous CD19 CAR T in MCL. Additional translational data from patients enrolled in the Phase 1 clinical study in relapsed/refractory B-cell non-Hodgkin’s Lymphoma, which further support the significant potential of ADI-001 in autoimmune indications, will be presented during the 9th Annual CAR-TCR Summit on September 19, 2024 in Boston, MA. Ankündigung • Aug 22
Adicet Bio, Inc. Announces Resignation of Michael Kauffman from the Board and Nominating and Corporate Governance Committee On August 15, 2024, Michael Kauffman, M.D., Ph.D., a Class III member of the board of directors of Adicet Bio, Inc., notified the Company of his resignation from the Board and Nominating and Corporate Governance Committee, effective as of August 19, 2024. Dr. Kauffman’s resignation from the Board was not the result of any disagreement with management or the Board or on any matter relating to the Company’s operations, policies or practices. Ankündigung • Aug 19
Adicet Bio, Inc. Announces the Appointment of Lloyd Klickstein to its Board of Directors Adicet Bio, Inc. announced the appointment of Lloyd Klickstein, M.D., Ph.D.to its Board of Directors. Dr. Klickstein has over two decades of leadership experience in the biopharmaceutical industry and biomedical research. He currently serves as President and Chief Executive Officer of Koslapp Therapeutics, Inc. and is the Board Chair of the Lupus Foundation of New England. Dr. Klickstein co-founded Versanis Bio, Inc., where he held multiple executive roles, prior to the Company’s acquisition by Eli Lilly and Co. Before that, he held positions of Chief Innovation Officer at Adicet, Chief Scientific Officer at resTORbio, Inc. (Adicet’s predecessor company) and served as an independent board member at Blade Therapeutics, Inc. Prior to that, Dr. Klickstein was the Global Head of Translational Medicine for the New Indication Discovery Unit and the Exploratory Disease Area at Novartis Institutes for Biomedical Research, overseeing the development of innovative programs across various therapeutic areas. Previously, he was an academic physician-scientist at Brigham and Women’s Hospital (BWH). Dr. Klickstein holds a B.S. from Tufts University and an M.D. and Ph.D. from Harvard University. He completed post-graduate clinical training in Internal Medicine, Rheumatology & Immunology at BWH and a post-doctoral research fellowship at the Center for Blood Research in Boston. Ankündigung • Jun 06
Adicet Bio Receives FDA Fast Track Designation for ADI-001 in Lupus Nephritis Adicet Bio, Inc. announced the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to ADI-001 for the potential treatment of relapsed/refractory class III or class IV lupus nephritis. Fast Track Designation is a process designed to facilitate the development and expedite the review of drugs intended to treat serious conditions and fill an unmet medical need. Ankündigung • Apr 24
Adicet Bio, Inc., Annual General Meeting, Jun 05, 2024 Adicet Bio, Inc., Annual General Meeting, Jun 05, 2024, at 17:00 US Eastern Standard Time. Agenda: To elect two class III directors; to approve an amendment to the Adicet Bio, Inc. Second Amended and Restated 2018 Stock Option and Incentive Plan to increase the number of shares of common stock authorized for issuance under the plan by 5,000,000 shares of common stock; to approve an amendment to our Third Amended and Restated Certificate of Incorporation to increase the number of authorized shares of common stock from 150,000,000 to 300,000,000; to approve an amendment to Third Amended and Restated Certificate of Incorporation; to approve, on a non-binding advisory basis, the frequency of future advisory votes on the compensation of named executive officers; to ratify the appointment of KPMG LLP as independent registered public accounting firm for the fiscal year ending December 31, 2024; and to transact any other business properly brought before the Annual Meeting or any adjournment or postponement of the Annual Meeting. Ankündigung • Apr 23
Adicet Bio, Inc. Highlights Preclinical Data Supporting IND Readiness for ADI-270 in an Oral Presentation at the ASGCT 27th Annual Meeting Adicet Bio, Inc. announced that an abstract featuring new preclinical data highlighting ADI-270, an armored allogeneic “off-the-shelf” gamma delta CAR (chimeric antigen receptor) T cell therapy candidate targeting CD70 positive cancers, has been selected for an oral presentation at the ASGCT 27th Annual Meeting taking place from May 7-11, 2024, in Baltimore, MD. The oral presentation will take place on May 10, 2024 in the Targeted Gene and Cell Therapy session, co-chaired by Adicet Bio’s Chief Scientific Officer, Blake Aftab, Ph.D. Findings from this study have further characterized and have provided comparative benchmarking for the mechanisms by which ADI-270 provides enhanced functionality and potency in CD70 positive expressing tumors such as clear cell renal cell carcinoma (ccRCC) and facilitates a robust anti-tumor effect that supports its continued development. The preclinical findings indicate: ADI-270 demonstrated potent in vitro cytotoxicity against multiple CD70 positive tumor cell lines expressing varying levels of CD70. ADI-270 demonstrated robust cytotoxicity against heterogeneous CD70 negative and CD70 positive tumor cell cultures, highlighting the potential of gamma delta CAR T cells to be effective against tumors with mixed antigen expression. ADI-270’s unique use of CD27-based targeting of CD70 demonstrated robust CAR-mediated killing in multiple cancer models including ccRCC, non-small cell lung cancer and T cell lymphoma, and including those models with lower levels of CD70 expression. ADI-270 inhibited tumor growth in the context of suppressive tumor microenvironment attributed to inclusion of dominant-negative transforming growth factor beta receptor and demonstrated resilience to clearance by host T cells attributed to the function of CD27-based CAR targeting of CD70 also expressed on host T cells. Robust anti-tumor effects in an in vivo model of ccRCC, such as tumor infiltration, proliferation, and effector function, were observed after administration, resulting in eradication of CD70 positive tumor cells. Ankündigung • Mar 23
Adicet Bio, Inc. has filed a Follow-on Equity Offering in the amount of $100 million. Adicet Bio, Inc. has filed a Follow-on Equity Offering in the amount of $100 million.
Security Name: Common Stock
Security Type: Common Stock
Transaction Features: At the Market Offering New Risk • Jan 26
New major risk - Shareholder dilution The company's shareholders have been substantially diluted in the past year. Increase in shares outstanding: 79% This is considered a major risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (19% average weekly change). Shareholders have been substantially diluted in the past year (79% increase in shares outstanding). Revenue is less than US$1m. Minor Risk Currently unprofitable and not forecast to become profitable over next 3 years (US$120m net loss in 3 years). New Risk • Jan 24
New minor risk - Shareholder dilution The company's shareholders have been diluted in the past year. Increase in shares outstanding: 16% This is considered a minor risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (19% average weekly change). Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$120m net loss in 3 years). Shareholders have been diluted in the past year (16% increase in shares outstanding). Ankündigung • Jan 23
Adicet Bio, Inc. has filed a Follow-on Equity Offering. Adicet Bio, Inc. has filed a Follow-on Equity Offering.
Security Name: Common Stock
Security Type: Common Stock
Security Name: Pre-Funded Warrants
Security Type: Equity Warrant Price Target Changed • Jan 06
Price target decreased by 18% to US$12.80 Down from US$15.67, the current price target is an average from 5 analysts. New target price is 429% above last closing price of US$2.42. Stock is down 71% over the past year. The company is forecast to post a net loss per share of US$3.36 next year compared to a net loss per share of US$1.70 last year. Ankündigung • Dec 11
Adicet Bio, Inc. Highlights ADI-001 Expansion, Persistence and Pharmacodynamic Profile from Ongoing Phase 1 Study At the 65Th American Society of Hematology Annual Meeting Adicet Bio, Inc. announced that an abstract outlining PK and PD profiling data fromtheCompany’s ongoing Phase 1 study of ADI-001 for the potential treatment of relapsed or refractory aggressive B-cell NHL was made available as part of the 65th ASH Annual Meeting, being held December 9-12, 2023 in San Diego, California. The data will be provided during a poster presentation at the ASH Annual Meeting on Sunday, December 10, 2023. ADI-001 is an investigational allogeneic gamma delta CAR T cell therapy being developed as a potential treatment for relapsed or refractory B-cell NHL. ADI-001 targets malignant B-cells via an anti-CD20 CAR and via the gamma delta innate and T cell endogenous cytotoxicity receptors. Gamma delta T cells engineered with an anti-CD20 CAR have demonstrated potent antitumor activity in preclinical models, leading to long-term control of tumor growth. ADI-001 was granted Fast Track Designation by the U.S. Food and Drug Administration (FDA) for the potential treatment of relapsed or refractory B-cell NHL. Price Target Changed • Aug 11
Price target decreased by 15% to US$18.29 Down from US$21.43, the current price target is an average from 7 analysts. New target price is 695% above last closing price of US$2.30. Stock is down 85% over the past year. The company is forecast to post a net loss per share of US$3.01 next year compared to a net loss per share of US$1.70 last year. New Risk • Aug 08
New minor risk - Market cap size The company's market capitalization is less than US$100m. Market cap: US$96.2m This is considered a minor risk. Companies with a small market capitalization are most likely businesses that have not yet released a product to market or are simply a very small company without a wide reach. Either way, risk is elevated with these companies because there is a chance the product may not come to fruition or the company's addressable market or demand may not be as large as expected. In addition, if the company's size is the main factor, it is less likely to have many investors and analysts following it and scrutinizing its performance and outlook. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (21% average weekly change). Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$105m net loss in 3 years). Shareholders have been diluted in the past year (7.4% increase in shares outstanding). Market cap is less than US$100m (US$96.2m market cap). Ankündigung • Jul 12
Adicet Bio, Inc. Announces Appointment of Katie Peng to the Board of Directors Adicet Bio, Inc. announced the appointment of Katie Peng to its Board of Directors. Ms. Peng brings extensive industry and commercial expertise to the Board. She currently serves as Chief Commercial Officer at Denali Therapeutics Inc., where she is leading the global commercialization efforts of Denali’s pipeline. Previously Ms. Peng served as the Senior Vice President, Head of the OMNI Business Unit at Genentech, Inc., where she was responsible for the oncology, neurology, and rare diseases portfolio representing approximately $14 billion in revenue, and served as part of Genentech’s commercial leadership team. Prior to Genentech, Ms. Peng held a number of senior leadership positions at Roche Holding AG, managing the Roche portfolio of over 30 products in the Asia Pacific region as the General Manager of two countries. Ms. Peng has successfully launched multiple products in neurology, oncology, and rare disease, notably including OCREVUS® (ocrelizumab), a therapeutic monoclonal antibody approved for the treatment of multiple sclerosis, Evrysdi® (risdiplam), a medicine used to treat spinal muscular atrophy (SMA) in adults and children, and HEMLIBRA® (emicizumab-kxwh), a bispecific antibody for the treatment of people with hemophilia A. Her experience spans marketing, sales, market access, medical affairs and business planning. Before joining Roche, Ms. Peng held several commercial roles at Amgen Inc. and began her career as a research scientist at Allergan plc. She holds a B.A. from the University of California, Berkeley and an M.B.A. from the Kelley School of Business, Indiana University. She also serves as a board member for California Life Sciences. New Risk • Jun 29
New minor risk - Market cap size The company's market capitalization is less than US$100m. Market cap: US$91.5m This is considered a minor risk. Companies with a small market capitalization are most likely businesses that have not yet released a product to market or are simply a very small company without a wide reach. Either way, risk is elevated with these companies because there is a chance the product may not come to fruition or the company's addressable market or demand may not be as large as expected. In addition, if the company's size is the main factor, it is less likely to have many investors and analysts following it and scrutinizing its performance and outlook. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (18% average weekly change). Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$95m net loss in 3 years). Shareholders have been diluted in the past year (7.4% increase in shares outstanding). Market cap is less than US$100m (US$91.5m market cap). Price Target Changed • Jun 28
Price target decreased by 14% to US$23.29 Down from US$27.00, the current price target is an average from 7 analysts. New target price is 993% above last closing price of US$2.13. Stock is down 85% over the past year. The company is forecast to post a net loss per share of US$2.46 next year compared to a net loss per share of US$1.70 last year. Ankündigung • Jun 27
Adicet Bio Reports Positive Data from Ongoing ADI-001 Phase 1 Trial in Patients with Relapsed or Refractory Aggressive B-Cell Non-Hodgkin’s Lymphoma (NHL) Adicet Bio, Inc. announced positive safety and efficacy data from the Company’s ongoing Phase 1 study of ADI-001 for the potential treatment of relapsed or refractory aggressive B-cell non-Hodgkin's lymphoma. Data highlights as of the May 4, 2023 data-cut date were as follows: Of the 24 efficacy-evaluable patients, 3 received ADI-001 at dose level 1 (DL1) (30 million CAR+ cells), 3 received ADI-001 at dose level 2 (DL2) (100 million CAR+ cells), 6 received ADI-001 at dose level 3 (DL3) (300 million CAR+ cells), 4 received two infusions of ADI-001 at DL3 (two doses of 300 million CAR+ cells, one on day 1 and the second dose on day 7 following a single lymphodepletion), and 8 received ADI-001 at dose level 4 (DL4) (1 billion CAR+ cells). Patients were heavily pretreated with a median of 4 prior lines of therapy (range 2-9), had relatively high tumor burden, and had a poor prognostic outlook based on their median International Prognostic Index (IPI) score. 50% of patients enrolled in the study had progressed on prior CAR T. ADI-001 treatment demonstrated a 71% ORR and 63% CR rate in the study across all dose levels. ADI-001 demonstrated an 83% ORR and 67% CR rate in heavily pre-treated patients (4 median prior lines of therapy) who had progressed on prior CAR T. ADI-001 demonstrated a 6-month CR rate consistent with autologous CAR T when factoring number of prior lines of therapy and percent of patients enrolled in the study who progressed on prior CAR T. Adicet selected the recommended Phase 2 dose (RP2D) as 1 billion CAR positive cells (DL4). At the RP2D (DL4) (with 4 median prior lines of therapy, 38% post-CAR T) the 6-month CR rate was 25%. At this dose level, in patients who had progressed on prior CAR T, the CR rate was 67% and the 6-month CR rate was 33%. The expansion and persistence of ADI-001 at the RP2D exceed values reported for approved autologous CD19 CAR T cell therapy. DL4 demonstrated a mean Cmax of 483 cells/ul with a mean time-to-peak at approximately day 9 and demonstrated persistence through day 28 with a mean concentration of 21 cells/ul. ADI-001 was generally well-tolerated in the study and there were no occurrences of dose-limiting toxicities or graft vs host disease (GvHD). Of the 24 patients evaluable for safety, there was 1 report of Grade 3 or higher CRS and 1 report of Grade 3 or higher ICANS. In May, the Company completed a Type B meeting with the FDA and expects to transition the ADI-001 program into a potentially pivotal Phase 2 study in post- CAR T LBCL in the first half of 2024. Price Target Changed • Jun 02
Price target decreased by 7.8% to US$25.44 Down from US$27.60, the current price target is an average from 9 analysts. New target price is 390% above last closing price of US$5.20. Stock is down 55% over the past year. The company is forecast to post a net loss per share of US$2.44 next year compared to a net loss per share of US$1.70 last year. Major Estimate Revision • May 25
Consensus EPS estimates upgraded to US$2.42 loss The consensus outlook for fiscal year 2023 has been updated. 2023 losses forecast to reduce from -US$2.75 to -US$2.42 per share. Revenue forecast unchanged from US$18.5m at last update. Biotechs industry in the US expected to see average net income decline 88% next year. Consensus price target of US$27.00 unchanged from last update. Share price fell 14% to US$5.71 over the past week. Ankündigung • May 19
Adicet Bio, Inc. Presents Positive Preclinical Data on ADI-270 At the American Society of Gene and Cell Therapy (ASGCT) 26Th Annual Meeting Adicet Bio, Inc. announced preclinical data highlighting ADI-270, an armored allogeneic “off-the-shelf” gamma delta CAR (chimeric antigen receptor) T cell therapy candidate targeting CD70+ cancers, at the 26th Annual Meeting of the American Society of Gene & Cell Therapy (ASGCT) taking place from May 16-20, 2023, in Los Angeles, CA. In this study, gamma delta T cells modified to express CD70 CAR were successfully generated and expanded without evident hindrances from CD70-mediated fratricide in the process. Data being presented included the following findings: ADI-270 demonstrated preclinical proof-of-concept as an armored allogeneic gamma delta CAR T cell therapy candidate utilizing the CD27 natural receptor in a third generation CAR format for targeting CD70-positive cancers. ADI-270 gamma delta 1 CAR T cells expressed a predominant naïve-like memory phenotype with potent in vitro cytotoxicity and production of proinflammatory cytokines against CD70+ tumor cell lines via multiple mechanisms. ADI-270 showed significant inhibition of tumor growth in CD70+ tumor cell lines, which was maintained in the presence of TGF beta inhibitory factor, and exhibited improved resistance to killing by host T cell rejection. ADI-270 also demonstrated marked bio-distribution and infiltration into solid tumor models of renal cell carcinoma. Major Estimate Revision • Mar 22
Consensus revenue estimates increase by 180%, EPS downgraded The consensus outlook for fiscal year 2023 has been updated. 2023 revenue forecast increased from US$6.35m to US$17.8m. EPS estimate fell from -US$1.97 to -US$2.30 per share. Biotechs industry in the US expected to see average net income decline 51% next year. Consensus price target down from US$27.60 to US$26.60. Share price fell 15% to US$6.57 over the past week. Reported Earnings • Mar 17
Full year 2022 earnings: EPS and revenues miss analyst expectations Full year 2022 results: US$1.70 loss per share. Revenue: US$25.0m (up 157% from FY 2021). Net loss: US$69.8m (loss widened 13% from FY 2021). Revenue missed analyst estimates by 29%. Earnings per share (EPS) also missed analyst estimates by 12%. Revenue is forecast to grow 50% p.a. on average during the next 3 years, compared to a 14% growth forecast for the Biotechs industry in the US. Recent Insider Transactions Derivative • Feb 16
Chief Technology Officer notifies of intention to sell stock Donald Healey intends to sell 10k shares in the next 90 days after lodging an Intent To Sell Form on the 10th of February. If the sale is conducted around the recent share price of US$7.98, it would amount to US$83k. Since September 2022, Donald's direct individual holding has increased from 31.40k shares to 39.47k. Company insiders have collectively sold US$199k more than they bought, via options and on-market transactions in the last 12 months. Major Estimate Revision • Dec 13
Consensus forecasts updated The consensus outlook for 2022 has been updated. 2022 revenue forecast increased from US$25.0m to US$35.4m. EPS estimate reaffirmed at -US$1.52 per share. Biotechs industry in the US expected to see average net income decline 93% next year. Consensus price target broadly unchanged at US$28.80. Share price fell 47% to US$10.43 over the past week. Recent Insider Transactions Derivative • Nov 18
CEO, President & Director notifies of intention to sell stock Chen Schor intends to sell 24k shares in the next 90 days after lodging an Intent To Sell Form on the 10th of November. If the sale is conducted around the recent share price of US$19.52, it would amount to US$468k. For the year to December 2020, Chen's total compensation was 5% salary and 95% other compensation. This indicates that these sales could comprise a meaningful part of their income for the year. Since March 2022, Chen's direct individual holding has increased from 53.42k shares to 96.89k. Company insiders have collectively sold US$199k more than they bought, via options and on-market transactions in the last 12 months. Board Change • Nov 16
High number of new and inexperienced directors There are 12 new directors who have joined the board in the last 3 years. The company's board is composed of: 12 new directors. No experienced directors. No highly experienced directors. Independent Director Jeff Chodakewitz is the most experienced director on the board, commencing their role in 2020. The following issues are considered to be risks according to the Simply Wall St Risk Model: Lack of board continuity. Lack of experienced directors. Reported Earnings • Nov 10
Third quarter 2022 earnings released: US$0.53 loss per share (vs US$0.44 loss in 3Q 2021) Third quarter 2022 results: US$0.53 loss per share (further deteriorated from US$0.44 loss in 3Q 2021). Net loss: US$22.0m (loss widened 57% from 3Q 2021). Revenue is forecast to grow 56% p.a. on average during the next 3 years, compared to a 14% growth forecast for the Biotechs industry in the US. Recent Insider Transactions Derivative • Oct 23
Senior VP & Chief Scientific Officer notifies of intention to sell stock Blake Aftab intends to sell 8k shares in the next 90 days after lodging an Intent To Sell Form on the 19th of October. If the sale is conducted around the recent share price of US$16.27, it would amount to US$131k. Since March 2022, Blake's direct individual holding has decreased from 20.90k shares to 11.24k. Company insiders have collectively sold US$199k more than they bought, via options and on-market transactions in the last 12 months. Buying Opportunity • Oct 07
Now 23% undervalued after recent price drop Over the last 90 days, the stock is down 20%. The fair value is estimated to be US$19.34, however this is not to be taken as a buy recommendation but rather should be used as a guide only. Revenue has grown by 266% over the last year. Earnings per share has grown by 51%. For the next 3 years, revenue is forecast to grow by 47% per annum. Earnings is also forecast to grow by 13% per annum over the same time period. Major Estimate Revision • Aug 27
Consensus forecasts updated The consensus outlook for 2022 has been updated. 2022 losses forecast to reduce from -US$1.52 to -US$1.25 per share. Revenue forecast unchanged from US$37.3m at last update. Biotechs industry in the US expected to see average net income decline 57% next year. Consensus price target broadly unchanged at US$28.44. Share price was steady at US$14.35 over the past week. Major Estimate Revision • Aug 17
Consensus revenue estimates fall by 34% The consensus outlook for revenues in 2022 has deteriorated. 2022 revenue forecast decreased from US$39.2m to US$25.8m. Forecast losses increased from -US$1.08 to -US$1.52 per share. Biotechs industry in the US expected to see average net income decline 57% next year. Consensus price target broadly unchanged at US$28.78. Share price fell 15% to US$14.12 over the past week. Reported Earnings • Aug 11
Second quarter 2022 earnings: EPS and revenues miss analyst expectations Second quarter 2022 results: US$0.56 loss per share (down from US$0.34 loss in 2Q 2021). Revenue: US$0 (down 100% from 2Q 2021). Net loss: US$22.5m (loss widened 108% from 2Q 2021). Profit margin: (up from net loss in 2Q 2021). The move to profitability was primarily driven by lower revenue. Revenue missed analyst estimates by 100%. Earnings per share (EPS) also missed analyst estimates by 21%. Over the next year, revenue is expected to shrink by 21% compared to a 52% growth forecast for the industry in the US. Recent Insider Transactions Derivative • Aug 05
Senior VP & Chief Scientific Officer notifies of intention to sell stock Blake Aftab intends to sell 7k shares in the next 90 days after lodging an Intent To Sell Form on the 1st of August. If the sale is conducted around the recent share price of US$16.64, it would amount to US$116k. Since March 2022, Blake has owned 20.90k shares directly. There has only been one transaction (US$171k sale) from insiders over the last 12 months. Major Estimate Revision • May 19
Consensus revenue estimates increase by 42% The consensus outlook for revenues in 2022 has improved. 2022 revenue forecast increased from US$27.6m to US$39.2m. Forecast losses expected to reduce from -US$1.51 to -US$1.09 per share. Biotechs industry in the US expected to see average net income decline 52% next year. Consensus price target of US$28.89 unchanged from last update. Share price was steady at US$10.44 over the past week. Reported Earnings • May 13
First quarter 2022 earnings: Revenues exceed analysts expectations while EPS lags behind First quarter 2022 results: EPS: US$0.12 (up from US$0.82 loss in 1Q 2021). Revenue: US$25.0m (down 728% from 1Q 2021). Net income: US$4.62m (up US$25.9m from 1Q 2021). Profit margin: 19% (down from 536% in 1Q 2021). The decrease in margin was primarily driven by lower revenue. Revenue exceeded analyst estimates by 17%. Earnings per share (EPS) also surpassed analyst estimates. Over the next year, revenue is expected to shrink by 33% compared to a 25% growth forecast for the industry in the US. Board Change • Apr 27
High number of new and inexperienced directors There are 12 new directors who have joined the board in the last 3 years. The company's board is composed of: 12 new directors. No experienced directors. No highly experienced directors. Independent Director Jeff Chodakewitz is the most experienced director on the board, commencing their role in 2020. The following issues are considered to be risks according to the Simply Wall St Risk Model: Lack of board continuity. Lack of experienced directors. Recent Insider Transactions Derivative • Apr 08
Chief Medical Officer & Senior VP notifies of intention to sell stock Francesco Galimi intends to sell 8k shares in the next 90 days after lodging an Intent To Sell Form on the 4th of April. If the sale is conducted around the recent share price of US$21.00, it would amount to US$168k. Since June 2021, Francesco's direct individual holding has increased from 6.98k shares to 27.92k. There has only been one transaction (US$42k purchase) from insiders over the last 12 months. Major Estimate Revision • Apr 01
Consensus forecasts updated The consensus outlook for 2022 has been updated. 2022 losses forecast to reduce from -US$1.86 to -US$1.50 per share. Revenue forecast unchanged from US$27.6m at last update. Biotechs industry in the US expected to see average net income decline 46% next year. Consensus price target of US$28.89 unchanged from last update. Share price rose 21% to US$20.81 over the past week. Major Estimate Revision • Mar 22
Consensus revenue estimates fall by 31% The consensus outlook for revenues in 2022 has deteriorated. 2022 revenue forecast decreased from US$22.2m to US$15.3m. Forecast losses increased from -US$1.50 to -US$1.86 per share. Biotechs industry in the US expected to see average net income decline 46% next year. Consensus price target down from US$30.13 to US$29.00. Share price rose 23% to US$15.12 over the past week. Reported Earnings • Mar 18
Full year 2021 earnings: EPS and revenues exceed analyst expectations Full year 2021 results: US$2.00 loss per share (up from US$5.01 loss in FY 2020). Net loss: US$62.0m (loss widened 69% from FY 2020). Products in clinical trials Phase I: 1 Revenue exceeded analyst estimates by 17%. Earnings per share (EPS) also surpassed analyst estimates by 5.8%. Over the next year, revenue is forecast to grow 57%, compared to a 60% growth forecast for the pharmaceuticals industry in the US. Recent Insider Transactions Derivative • Feb 22
Founder & Independent Director notifies of intention to sell stock Aya Jakobovits intends to sell 14k shares in the next 90 days after lodging an Intent To Sell Form on the 16th of February. If the sale is conducted around the recent share price of US$15.09, it would amount to US$211k. Since March 2021, Aya's direct individual holding has decreased from 918.61k shares to 858.76k. There has only been one transaction (US$42k purchase) from insiders over the last 12 months. Recent Insider Transactions Derivative • Dec 30
Founder & Independent Director notifies of intention to sell stock Aya Jakobovits intends to sell 19k shares in the next 90 days after lodging an Intent To Sell Form on the 22nd of December. If the sale is conducted around the recent share price of US$16.51, it would amount to US$314k. Since March 2021, Aya's direct individual holding has decreased from 918.61k shares to 896.76k. There has only been one transaction (US$42k purchase) from insiders over the last 12 months. Reported Earnings • Nov 12
Third quarter 2021 earnings released: US$0.44 loss per share (vs US$2.84 loss in 3Q 2020) Third quarter 2021 results: Net loss: US$14.0m (loss narrowed 5.2% from 3Q 2020). Reported Earnings • Aug 13
Second quarter 2021 earnings released: US$0.34 loss per share (vs US$0.48 loss in 2Q 2020) Second quarter 2021 results: Net loss: US$10.9m (loss widened 28% from 2Q 2020). Executive Departure • Jun 15
Senior VP, Chief Scientific & Operating Officer Stewart Abbot has left the company On the 11th of June, Stewart Abbot's tenure as Senior VP, Chief Scientific & Operating Officer ended after less than a year in the role. We don't have any record of a personal shareholding under Stewart's name. A total of 3 executives have left over the last 12 months. The current median tenure of the management team is less than a year, which is considered inexperienced in the Simply Wall St Risk Model. Recent Insider Transactions Derivative • Jun 08
CEO, President & Director notifies of intention to sell stock Chen Schor intends to sell 54k shares in the next 90 days after lodging an Intent To Sell Form on the 3rd of June. If the sale is conducted around the recent share price of US$12.47, it would amount to US$672k. For the year to December 2020, Chen's total compensation was 4% salary and 96% other compensation. This indicates that these sales could comprise a meaningful part of their income for the year. Since December 2020, Chen's direct individual holding has decreased from 296.41k shares to 197.61k. There have been no trades via on-market transactions or options from company insiders in the last 12 months. Reported Earnings • May 19
First quarter 2021 earnings released: US$0.82 loss per share (vs US$0.26 loss in 1Q 2020) First quarter 2021 results: Revenue: -US$3.98m (down 299% from 1Q 2020). Net loss: US$21.3m (loss widened 375% from 1Q 2020).