On November 6, 2024 Adicet Bio, Inc. (Nasdaq: ACET), a clinical stage biotechnology company discovering and developing allogeneic gamma delta T cell therapies for autoimmune diseases and cancer, reported financial results and operational highlights for the third quarter ended September 30, 2024 (Press release, Adicet Bio, NOV 6, 2024, View Source [SID1234647871]).

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"Our commitment to delivering best-in-class gamma delta 1 T cell therapies for patients battling autoimmune diseases and cancer is reflected in the expansion of our clinical pipeline in the third quarter. We are now investigating ADI-001 across six autoimmune indications to provide potentially transformative curative therapies for these debilitating diseases. Additionally, in the fourth quarter we plan to open enrollment for our Phase 1 trial of ADI-270 in patients with metastatic/advanced clear cell renal cell carcinoma (ccRCC), our first gamma delta 1 CAR T cell therapy for solid tumors. This progress highlights the broad and important potential applications of our gamma delta platform," said Chen Schor, President and Chief Executive Officer. "Looking ahead, we anticipate advancing enrollment in these trials and expect to share preliminary clinical data from both lupus nephritis with ADI-001 and metastatic/advanced ccRCC with ADI-270 in the first half of 2025."

Third Quarter 2024 and Recent Operational Highlights:

Autoimmune diseases

Activated clinical sites in ADI-001 Phase 1 trial in autoimmune diseases. In September 2024, Adicet activated sites for its Phase 1 clinical trial of ADI-001 in autoimmune diseases. The company is exploring the potential of ADI-001 across six indications including LN, systemic lupus erythematosus (SLE), systemic sclerosis (SSc), idiopathic inflammatory myopathy (IIM), stiff person syndrome (SPS) and anti-neutrophil cytoplasmic autoantibody (ANCA) associated vasculitis (AAV). The Company opened enrollment for patients with LN in 4Q24 and expects to initiate enrollment for patients with SLE, SSc, IIM, and SPS in 1Q25, and for patients with AAV in 2H25. The Company plans to report preliminary clinical data from the Phase 1 clinical study of ADI-001 in LN in 1H25, and for other autoimmune diseases in 2H25, subject to study site initiation and patient enrollment.
FDA clearance of IND amendment to evaluate ADI-001 in IIM and SPS. In October 2024, Adicet announced that the U.S. Food and Drug Administration (FDA) cleared the Company’s Investigational New Drug (IND) amendment application to evaluate ADI-001 in IIM and SPS as part of the Phase 1 clinical trial in autoimmune diseases.
Presented ADI-001 clinical biomarker data demonstrating robust tissue trafficking and complete B cell depletion in secondary lymphoid tissue. In September 2024, Adicet presented clinical biomarker data from the Phase 1 GLEAN trial of ADI-001 at the 9th Annual CAR-TCR Summit. The data 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 findings further reinforce ADI-001’s potential as a best-in-class allogeneic cell therapy for autoimmune diseases.
Presentation of ADI-001 clinical data at the American College of Rheumatology (ACR) Convergence 2024. In November 2024, Adicet will present an oral abstract highlighting previously presented ADI-001 clinical biomarker data at ACR Convergence 2024 taking place November 14-19 in Washington, D.C.
Hematologic malignancies and solid tumor indications

ADI-270 Fast Track Designation in metastatic/ advanced ccRCC. In July 2024, Adicet announced that the FDA granted ADI-270 Fast Track Designation for the potential treatment of patients with metastatic/advanced ccRCC who have been treated with an immune checkpoint inhibitor and a vascular endothelial growth factor inhibitor.
Presented ADI-270 data at the American Society of Gene & Cell Therapy’s (ASGCT) (Free ASGCT Whitepaper) 2024 Advancing Gene + Cell Therapies for Cancer conference. In October 2024, Adicet presented ADI-270 data in an oral presentation at the ASGCT (Free ASGCT Whitepaper) 2024 Advancing Gene and Cell Therapies for Cancer conference.
Corporate Updates

Appointed Lloyd Klickstein, M.D., Ph.D. to Board of Directors. In August 2024, Adicet appointed Dr. Lloyd Klickstein to its Board of Directors. Dr. Klickstein brings over two decades of leadership experience in the biopharmaceutical industry and biomedical research, and expertise in rheumatology and immunology to Adicet. Dr. Klickstein currently serves as President and Chief Executive Officer of Koslapp Therapeutics, Inc. and is the Board Chair of the Lupus Foundation of New England.
Financial Results for Third Quarter 2024:

Research and Development (R&D) Expenses: R&D expenses were $26.3 million for the three months ended September 30, 2024, compared to $26.2 million during the same period in 2023. The increase in R&D expenses was primarily due to a $0.9 million increase in laboratory expenses, a $0.8 million increase in payroll and personnel expenses as well as a less than $0.1 million increase in professional fees for the period. This increase was partially offset by a $1.3 million decrease in expenses related to contract development manufacturing organizations and other externally conducted research and development and a $0.4 million decrease in allocated facility expenses.
General and Administrative (G&A) Expenses: G&A expenses were $6.9 million for the three months ended September 30, 2024, compared to $6.6 million during the same period in 2023. The increase in general and administrative expenses was primarily due to a $0.3 million increase in payroll and personnel expenses.
Net Loss: Net loss for the three months ended September 30, 2024 was $30.5 million, or a net loss of $0.34 per basic and diluted share, including non-cash stock-based compensation expense of $6.8 million, as compared to a net loss of $49.9 million, or a net loss of $1.16 per basic and diluted share, including non-cash goodwill impairment expense of $19.5 million and non-cash stock-based compensation expense of $5.6 million during the same period in 2023.
Cash Position: Cash, cash equivalents and short-term investments in treasury securities were $202.1 million as of September 30, 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 September 30, 2024, will be sufficient to fund its operating expenses into the second half of 2026.

On November 6, 2024 Affini-T Therapeutics, Inc., a clinical stage biopharmaceutical company focused on the development of precision immunotherapies for treatment of patients with solid tumors, reported that a Trial-In-Progress poster for the Company’s Phase 1 clinical trial evaluating AFNT-211 targeting KRAS G12V will be presented at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 39th Annual Meeting held in Houston, TX, November 6-10 (Press release, Affini-T Therapeutics, NOV 6, 2024, View Source [SID1234647870]). The team will present three additional posters with preclinical data from its non-viral TRAC-knocked-in T cell therapy targeting TP53-R175H and bi-specific T cell engager programs targeting TP53-R175H, KRAS G12D and KRAS G12V.

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"We are going after cancers with tumor driver mutations like KRAS," said Dirk Nagorsen, M.D., Chief Medical Officer, Affini-T Therapeutics. "Our two clinical stage programs, AFNT-111 and AFNT-211, are specifically designed to leverage precision immunotherapy and synthetic biology approaches to target oncogenic driver mutation KRAS G12V in HLA-A*11:01-positive patients. We started treating patients across these trials earlier this year and we continue to advance these programs through Phase 1."

"Our mission is to address the significant unmet needs of patients with hard-to-treat solid tumors by advancing precision engineered T cell and bispecific T cell engager immunotherapies that target oncogenic driver mutations," said Loïc Vincent, Ph.D., Chief Scientific Officer, Affini-T Therapeutics. "We believe that our non-viral multi-kilobase size gene targeted knock-in platform, THRIVETM, will enable us to cost-effectively engineer safe and effective T cell therapy products. We look forward to presenting new preclinical data for THRIVETM-engineered TP53 R175H-targeting TCR T cells (AFNT-313). We will also be disclosing, for the first time, preclinical data for T cell engagers targeting TP53 R175H and KRAS G12V/D mutations from Affini-T’s TETHERTM bispecific platform."

Poster presentation details are as follows:

Title: A Phase 1 Study of Autologous CD4+ and CD8+ T Cells, HLA-A*11:01-restricted, KRAS G12V-specific, Transgenic TCR; CD8α/β Coreceptor and a FAS41BB Switch Receptor in Patients with Solid Tumors
Abstract #662, Primary Category: Clinical Trials in Progress
Presenting Author: Soumit Basu, M.D., Senior Medical Director, Clinical Development, Affini-T Therapeutics
Session Date/Time: Saturday, November 9, 2024, 12:15 PM – 1:45 PM CST and 7:10 PM – 8:30 PM CST

Title: A Non-Virally Engineered T Cell Therapy Targeting the Hotspot Mutation R175H in TP53 with Signals 1, 2, and 3 (TCR, Co-stimulation, and Cytokine) Drives a Coordinated Antitumor CD4/8 T Cell Response
Abstract #393, Primary Category: Cellular Therapies
Presenting Author: Santosh Narayan, Ph.D., Senior Scientist, Immunology & Gene Editing, Affini-T Therapeutics
Session Dates/Times: Immune Engineering Workshop, Thursday, November 7, 2024, 3:10 PM – 5:00 PM CST and Annual Meeting, Friday, November 8, 2024, 12:15 PM – 1:45 PM CST and 5:30 PM – 7:00 PM CST

Title: T Cell Engagers Targeting HLA-A*11:01 KRAS-G12D and KRAS-G12V Mutations for Cancer Immunotherapy
Abstract #1066, Primary Category: Immuno-Conjugates and Chimeric Molecules
Presenting Author: Mark Ng, MS, Senior Scientist II, TCR Discovery, Affini-T Therapeutics
Session Dates/Times: Immune Engineering Workshop, Thursday, November 7, 2024, 3:10 PM – 5:00 PM CST and Annual Meeting, Saturday, November 9, 2024, 12:15 PM – 1:45 PM CST and 7:10 PM – 8:30 PM CST

Title: A Novel T Cell Engager Targeting HLA-A*02:01 TP53-R175H for Cancer Immunotherapy
Abstract #1315, Primary Category: Novel Single-Agent Immunotherapies
Presenting Author: Mark Ng, MS, Senior Scientist II, TCR Discovery, Affini-T Therapeutics
Session Dates/Times: Immune Engineering Workshop, Thursday, November 7, 2024, 3:10 PM – 5:00 PM CST and Annual Meeting, Friday, November 8, 2024, 12:15 PM – 1:45 PM CST and 5:30 PM – 7:00 PM CST

About AFNT-211

AFNT-211 is an investigational autologous T cell therapy that is being administered to patients for the first time. AFNT-211 is currently being evaluated in a Phase 1 clinical trial open to adult patients with solid tumors who have a KRAS G12V mutation. Additional information on the ongoing clinical trial can be accessed at clinicaltrials.gov, NCT06105021.

On November 6, 2024 Immunomic Therapeutics, Inc., ("ITI"), a privately-held clinical-stage biotechnology company pioneering the study of LAMP-mediated nucleic acid-based immunotherapy reported that it will present at SITC (Free SITC Whitepaper) 39th Annual Meeting 2024 at the George R. Brown Convention Center in Houston, TX on November 8-10, 2024 (Press release, Immunomic Therapeutics, NOV 6, 2024, View Source [SID1234647869]). Associate Director, Vaccine Discovery, Wei Shen, Ph.D., will present a poster entitled, "A UNITE-based self-amplifying RNA vaccine advances anti-tumor immunity in a murine triple-negative breast cancer model" on Friday, November 8th & Saturday, November 9th, 2024.

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Poster Presentation details are as follows:

Abstract: 223
Title: A UNITE-based self-amplifying RNA vaccine advances anti-tumor immunity in a murine triple-negative breast cancer model
Date and Time: Friday, November 8, 2024 ǀ 9:00 a.m.- 7:00 p.m. CST & Saturday, November 9, 2024 ǀ 9:00 a.m.- 8:30 p.m. CST
Poster Number: 223
Where: George R. Brown Convention Center, Level 1, Exhibit Halls AB
Speaker: Dr. Wei Shen, Ph.D.

About UNITE

ITI’s investigational UNITE platform, UNiversal Intracellular Targeted Expression, leverages the ability to engineer chimeric proteins, directing antigen presenting cells to present antigens to the immune system through a targeted pathway and driving a robust immune response. UNITE vaccines are distinct in that they combine two components: nucleic acid constructs that encode a specific antigen and an endogenous Lysosomal Associated Membrane Protein (LAMP-1) sequence. The UNITE platform harnesses LAMP-1 as a means of presenting the vaccine target to the immune system, resulting in antibody production, inflammatory cytokine release, and establishing critical immunological memory, something that other vaccine approaches commonly lack. This approach could put UNITE technology at the crossroads of immunotherapies in multiple indications, including cancer, human allergy, animal health, and infectious disease. Preclinical data is currently being developed to explore whether LAMP-1 nucleic acid constructs may amplify and activate the immune response in highly immunogenic tumor types and used to create immune responses in tumor types that otherwise do not provoke an immune response.

On November 6, 2024 BostonGene, a leading provider of AI-driven molecular and immune profiling solutions, reported the Company will present six posters at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) 39th Annual Meeting taking place November 6-10, 2024 at the George R. Brown Convention Center in Houston, Texas (Press release, BostonGene, NOV 6, 2024, View Source [SID1234647868]). The research, conducted in collaboration with leading cancer centers, showcases the impact of BostonGene’s technology in advancing cancer treatment strategies, from deep molecular insights to predictive biomarkers. BostonGene will also exhibit at booth 514.

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BostonGene session details are below:

Abstract number: 135
Title: Multiplex immunofluorescence of whole slide images for enhanced tumor microenvironment immune cell characterization in multiple cancer types
Date & time: Friday, November 8 | 9:00 AM to 7:00 PM CST
Presenter: Vladimir Kushnarev, MD, PhD, BostonGene

This study used BostonGene’s MxIF pipeline that combines cell segmentation and spatial analysis to identify the immune cell types in various tumor microenvironment (TME) subtypes across multiple cancer types. The findings revealed the diverse nature of TME landscapes across cancers and the necessity for tailored immunotherapeutic approaches.

Abstract number: 161
Title: The predictive role of comprehensive genomic profiling in angiosarcoma immunotherapy
Date & time: Friday, November 8 | 9:00 AM to 7:00 PM CST
Presenter: Nikita Kotlov, BostonGene

Comprehensive genomic profiling (CGP) of angiosarcomas, a rare and aggressive form of cancer, revealed genetic changes critical for targeted therapy selection. Transcriptomic analysis also uncovered possible associations between tumor microenvironment (TME) subtypes and immunotherapy response, highlighting the importance of CGP in aiding treatment selection and expanding treatment options for angiosarcomas.

Research conducted in collaboration with The University of Texas MD Anderson Cancer Center

Abstract number: 183
Title: Comprehensive molecular profiling in the management of patients with diverse sarcoma subtypes
Date & time: Friday, November 8 | 9:00 AM to 7:00 PM CST
Presenter: Francesca Paradiso, PhD, BostonGene

Comprehensive molecular profiling (CGP) of sarcomas, which are highly heterogeneous, uncovered over 1,000 genetic alterations across 47 histological subtypes among 356 patients. Whole exome sequencing revealed approximately 400 actionable findings that are associated with approved therapy or inclusion criteria in clinical trials, and RNA-seq-based analysis identified diagnostic fusions and unique compositional features of various TME subtypes. These findings underscore a potential role of CGP in guiding treatment options for rare sarcomas.

Research conducted in collaboration with Massachusetts General Hospital Cancer Center and Sarcoma Oncology Center

Abstract number: 46
Title: Comprehensive machine learning-driven platform infers key tumor characteristics from blood-derived cfRNA
Date & time: Saturday, November 9 | 9:00 AM to 8:30 PM CST
Presenter: Andrey Shubin, PhD, BostonGene

A comprehensive machine learning platform was constructed to analyze the transcriptomic data from blood-derived cell-free RNA (cfRNA) of healthy donors and cancer patients to infer clinically important features and biomarkers of malignancies. Coupled with robust cell-free DNA (cfDNA) harvesting protocols, this universal platform offers unprecedented insights into tumor biology and can potentially characterize any tumor-associated transcriptomic changes reflected in the cfRNA.

Abstract number: 144
Title: Identifying a composite signature for predicting immune-related adverse events in advanced melanoma patients treated with immune checkpoint blockade
Date & time: Saturday, November 9 | 9:00 AM to 8:30 PM CST
Presenter: Michael Goldberg, PhD, BostonGene

Using flow cytometry and bulk RNA-seq to analyze blood cells of advanced melanoma patients collected before immune checkpoint blockade (ICB) treatment, we examined if the occurrence of immune-related adverse events (irAEs), severe and potentially fatal side effects of ICB, can be predicted. irAE signatures were constructed and used to detect distinct cellular and gene expression patterns among patients who developed severe irAEs post-ICB treatment. These signatures can potentially identify patients likely to develop irAEs, enabling timely mitigation to improve patient outcomes.

Abstract number: 170
Title: Identifying novel targets for antibody-drug conjugates in sarcomas using RNA sequencing
Date & time: Saturday, November 9 | 9:00 AM to 8:30 PM CST
Presenter: Vladimir Kushnarev, MD, PhD, BostonGene

RNA sequencing uncovered the expression landscape of potential antibody-drug conjugate (ADC) targets in sarcomas, particularly those lowly expressed in normal tissues. The combined expression of ADC targets with tertiary lymphoid structure and immune checkpoint gene signatures also depicts the immune landscape of sarcomas and can guide the development of immunotherapy approaches. Our findings revealed many genes that are precluded from existing clinical trials, underscoring the need to advance clinical trials and precision oncology in sarcoma therapies that prioritize safety and efficacy.

Research conducted in collaboration with The University of Texas MD Anderson Cancer Center, Massachusetts General Hospital Cancer Center, Memorial Sloan Kettering Cancer Center and Sarcoma Oncology Center

On November 6, 2024 Tango Therapeutics, Inc. (NASDAQ: TNGX), a clinical-stage biotechnology company committed to discovering and delivering the next generation of precision cancer medicines, reported its financial results for the third quarter ended September 30, 2024, and provided business highlights (Press release, Tango Therapeutics, NOV 6, 2024, View Source [SID1234647867]).

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"We have made great progress with our PRMT5 development program, including positive data from the TNG462 phase 1/2 clinical trial that showcase the best-in-class potential of TNG462 in multiple tumor types, including pancreatic and non-small cell lung cancers (NSCLC). Based on these early data, we are advancing TNG462 into trials with multiple targeted and standard of care combinations, including two RAS(ON) tri-complex inhibitors from Revolution Medicines. Given that nearly all MTAP-deleted pancreatic cancer has a co-occurring RAS mutation, we believe this could be a powerful approach to changing the treatment landscape for this challenging cancer," said Barbara Weber, M.D., President and Chief Executive Officer of Tango Therapeutics. "As part of the expanded capabilities needed to rapidly move TNG462 development forward, Dr. Maeve Waldron-Lynch, M.D. is joining Tango as Senior Vice President, Head of Clinical Development. Dr. Waldron-Lynch has extensive late-stage oncology clinical development and regulatory experience and will be invaluable as we prepare to advance TNG462 to registration."

In a separate press release issued earlier today, Tango Therapeutics provided an update on its ongoing PRMT5 clinical development program:

Data from the ongoing phase 1/2 clinical trial of TNG462, a potentially best-in-class MTA-cooperative PRMT5 inhibitor, demonstrate clinical activity across multiple tumor types, including NSCLC and pancreatic cancer. Of note, this includes an ORR of 43% in cholangiocarcinoma (n=7). Substantive durability and a good safety and tolerability profile also were observed in this ongoing trial. The next clinical update is expected in 2025.
The Company plans to initiate multiple targeted and standard of care combinations with TNG462 including RAS(ON) multi-selective and RAS(ON) G12D-selective inhibitors (Revolution Medicines), osimertinib (AstraZeneca) and pembrolizumab (Merck). These studies are expected to begin enrolling in 1H 2025.
TNG908, an MTA-cooperative brain-penetrant PRMT5 inhibitor, is clinically active and well-tolerated across non-CNS cancers in the phase 1/2 clinical trial. In particular, there were a total of nine evaluable pancreatic cancer patients, two with partial responses (ORR 22%) and five with stable disease as best response to date. The five ongoing pancreatic cancer patients have been on study for an average of 24 weeks, the longest for 72 weeks.
TNG908 did not demonstrate activity in glioblastoma (n=23 at active doses) likely because CNS exposure did not meet the required exposure threshold for clinical efficacy.
TNG908 enrollment is being stopped to allow full resourcing of TNG462 as a potential best-in-class molecule. In particular, the notably longer time on treatment observed – 24 weeks and still increasing for TNG462 versus 16 weeks for TNG908 – the superior target coverage, and the safety and tolerability profile all support selection of TNG462 for further development.
TNG456 is a next-generation brain-penetrant MTA-cooperative PRMT5 inhibitor that is 55X selective for MTAP deletion with 20 nM potency. Preclinical studies suggest TNG456 central nervous system exposure has the potential to be sufficient for meaningful efficacy in glioblastoma and brain metastases.
The Company expects to begin enrolling patients in the planned phase 1/2 trial during 1H 2025.
Business Highlights

Clinical collaboration with Revolution Medicines

In November 2024, the Company entered into a clinical collaboration with Revolution Medicines to evaluate the efficacy and safety of TNG462 in combination with RMC-6236, a RAS(ON) multi-selective inhibitor, and with RMC-9805, a RAS(ON) G12D-selective inhibitor.
The agreement provides that Revolution Medicines will supply RMC-6236 and RMC-9805 to Tango and that Tango will be the sponsor of any combination trials. Each company will retain commercial rights to their respective compounds and the agreement is mutually non-exclusive.
TNG260, a first-in-class, highly selective CoREST complex inhibitor

The TNG260 phase 1/2 clinical trial is ongoing, evaluating safety, pharmacokinetics, pharmacodynamics and efficacy of TNG260 in combination with pembrolizumab in patients with locally advanced or metastatic solid tumors with an STK11 loss-of-function mutation. To date, safety, tolerability and pharmacokinetic profiles are favorable.
STK11 mutations occur in approximately 15% of non-small cell lung, 15% of cervical, 10% of carcinoma of unknown primary, 5% of breast and 3% of pancreatic cancers.
Upcoming Milestones

TNG462 clinical data update expected in 2025
TNG462 combination trial enrollment expected to begin 1H 2025
TNG456 phase 1/2 trial enrollment expected to begin 1H 2025
TNG260 clinical data expected in 2025
Additional Business and Pipeline Highlights

Leadership Update

Maeve Waldron-Lynch, M.D. will join Tango as Senior Vice President, Head of Clinical Development later this month. In this role, Dr. Waldron-Lynch will lead clinical development functions under Adam Crystal, M.D., Ph.D., President of Research and Development at Tango. Dr. Waldron-Lynch most recently served as VP and Global Clinical Program Head at MorphoSys, where she oversaw the clinical program for tafasitamab. Prior to MorphoSys, she was a Clinical Development Medical Director at Novartis. Dr. Waldron-Lynch also has served as Senior Clinical Director, Oncology at Roche, and as Associate Director of Medical Science, Oncology at Mundipharma. Dr. Waldron-Lynch graduated from the University College Cork School of Medicine and served as a Specialty Registrar Medical Oncology at the Royal College of Physicians of Ireland, and a Clinical Fellow in Medical Oncology at the Yale University School of Medicine.

Financial Results

As of September 30, 2024, the Company held $293.3 million in cash, cash equivalents and marketable securities, which the Company expects to be sufficient to fund operations into the third quarter of 2026, including for additional planned TNG462 and TNG456 clinical trials.

Collaboration revenue was $11.6 million for the three months ended September 30, 2024, compared to $10.7 million for the same period in 2023, and $25.9 million for the nine months ended September 30, 2024 compared to $26.1 million for the same period in 2023. Collaboration revenue increased due to changes to estimated costs expected to be incurred under the collaboration during the three months ended September 30, 2024.

License revenue was $0 and $12.1 million for the three and nine months ended September 30, 2024, respectively, compared to $0 and $5.0 million for the three and nine months ended September 30, 2023, respectively. The year-to-date increase is primarily due to licensing a drug discovery program to Gilead for $12.0 million during the second quarter of 2024 as compared to Gilead licensing a program for $5.0 million during the second quarter of 2023.

Research and development expenses were $33.3 million for the three months ended September 30, 2024, compared to $27.1 million for the same period in 2023, and $110.0 million for the nine months ended September 30, 2024 compared to $83.9 million for the same period in 2023. The change is due to increased spend related to the advancement of TNG462, preclinical programs and personnel-related costs to support our research and development activities.

General and administrative expenses were $11.2 million for the three months ended September 30, 2024, compared to $9.2 million for the same period in 2023, and $32.7 million for the nine months ended September 30, 2024 compared to $26.4 million for the same period in 2023. The change was primarily due to increases in personnel-related costs.

Net loss for the three months ended September 30, 2024 was $29.2 million, or $0.27 per share, compared to a net loss of $22.3 million, or $0.23 per share, in the same period in 2023. Net loss for the nine months ended September 30, 2024 was $92.6 million, or $0.85 per share, compared to a net loss of $71.0 million, or $0.78 per share, in the same period in 2023.