Turnstone Biologics Announces Strategic Restructuring to Prioritize Portfolio and Extend Financial Runway

Rhea-AI Summary

Turnstone Biologics Corp. (Nasdaq: TSBX) has announced a strategic restructuring to prioritize its clinical program and extend its financial runway. The key points include:

• Reducing workforce by approximately 60%
• Focusing resources on advancing the TIDAL-01 Phase 1 program
• Extending cash runway into Q2 2026
• Streamlining operations and leadership team

The company will prioritize the development of TIDAL-01, its Selected TIL therapy, which has shown promising initial data in treating solid tumors. Recent results include a complete response in a heavily pre-treated late-line microsatellite stable colorectal cancer patient. Turnstone expects to provide a clinical update in the first half of 2025.

Positive

• Extending cash runway into Q2 2026, providing an additional three quarters of funding
• Focusing resources on advancing TIDAL-01 Phase 1 program, which has shown promising initial data
• Achieved complete response in a heavily pre-treated late-line MSS-CRC patient with progression-free survival beyond one year
• Streamlining operations to maximize shareholder value

Negative

• Reducing workforce by approximately 60%
• Discontinuing development of other preclinical pipeline assets
• Multiple leadership transitions, including departures of key executives

Insights

Financial Analyst

This restructuring announcement is a significant development for Turnstone Biologics. The company is taking decisive action to extend its cash runway and focus on its most promising clinical program. Key points:

• 60% workforce reduction, indicating substantial cost-cutting measures
• Cash runway extended into Q2 2026, providing an additional three quarters of operational funding
• Prioritization of TIDAL-01, the company's Phase 1 Selected TIL therapy program
• Multiple leadership changes, including new heads of clinical development, manufacturing and finance

The focus on TIDAL-01 follows encouraging initial data, including a complete response in a late-line MSS-CRC patient. This strategic shift could potentially accelerate the path to market for their lead asset. However, the significant workforce reduction may impact the company's ability to advance other pipeline projects rapidly.

From a financial perspective, the extended cash runway is important for a clinical-stage biotech, reducing the near-term need for dilutive financing. Investors should monitor upcoming clinical updates in H1 2025 for TIDAL-01, as positive results could drive significant value creation.

Biotechnology Expert

Turnstone's strategic restructuring represents a calculated risk in the competitive field of cancer immunotherapy. The company's decision to focus on Selected TIL therapy, particularly TIDAL-01, is based on promising early clinical data. Key scientific and operational considerations include:

• Novel unbiased TIL selection method potentially offering improved efficacy
• Complete response observed in a difficult-to-treat MSS-CRC patient
• Ongoing trials in colorectal, head and neck and uveal melanoma cancers
• Streamlined manufacturing and technical operations under new leadership

The restructuring allows Turnstone to allocate resources more efficiently towards manufacturing and clinical development of TIDAL-01. This focus could accelerate the program's progress and potentially lead to breakthrough treatments in solid tumors with high unmet needs.

However, the significant reduction in workforce may limit the company's ability to pursue multiple programs simultaneously or quickly pivot if challenges arise with TIDAL-01. The success of this strategy heavily depends on the continued positive performance of their lead asset in ongoing clinical trials.

• Realigning resources to focus on clinical advancement of Selected TIL therapy
  
• Reducing employee headcount by approximately 60%
• Streamlining operations with cash runway expected to extend into 2Q 2026
  

SAN DIEGO, Oct. 11, 2024 (GLOBE NEWSWIRE) -- Turnstone Biologics Corp. (“Turnstone” or the “Company”) (Nasdaq: TSBX), a clinical-stage biotechnology company developing a differentiated approach to treat and cure patients with solid tumors by pioneering selected tumor-infiltrating lymphocyte (Selected TIL) therapy, today announced a strategic prioritization of its pipeline, as well as a workforce reduction of approximately 60% and changes to its leadership team, to focus resources on the continued advancement of its Phase 1 program, TIDAL-01. As a result of the restructuring initiatives that align with the Company’s near-term goals, the anticipated cost savings are expected to extend its cash runway into the second quarter of 2026 and maximize shareholder value.

“Following a comprehensive evaluation of our business operations, we have decided to prioritize our pipeline and sharpen our clinical focus,” said Sammy Farah, M.B.A., Ph.D., Turnstone’s President and Chief Executive Officer. “As a result, we have made the decision to streamline our team, align resources towards manufacturing and clinical development, and optimize our cost structure. We expect these changes will extend our cash runway by three additional quarters, further enabling us to build upon our encouraging initial Phase 1 data, which demonstrated the potential of our Selected TILs in high unmet need solid tumors and potentially generate near-term value for our shareholders, while continuing to shape a strong company for the future.”

Dr. Farah added: “These mission-driven measures impact a number of our talented colleagues. I would like to convey my gratitude for their innumerable contributions to Turnstone, their commitment to patients with solid tumors, and I wish them the very best in their future endeavors.”

The comprehensive review of the Company’s corporate outlook and pipeline have outlined the following key strategic decisions:

Portfolio Prioritization

• The Company will direct resources towards advancing the development of its clinical program, TIDAL-01, over other preclinical pipeline assets. Turnstone’s Selected TIL process is designed to utilize a novel unbiased identification and functional screening method to isolate and selectively expand the greatest breadth of the most potent tumor-reactive TIL from the patient’s tumor in vitro, before infusing them into the patient for more targeted tumor killing.
• Turnstone recently reported initial positive data from the STARLING trial that support the biological hypothesis for TIL selection and warrant further development. The initial data showcased the achievement of a complete response in a heavily pre-treated late-line microsatellite stable colorectal cancer (MSS-CRC) patient with progression free survival extending beyond one year.
• TIDAL-01 is currently being evaluated in multiple Phase 1 trials including patients with colorectal cancer, head and neck cancer, and uveal melanoma, and the Company expects to provide a clinical update in the first half of 2025.
  

Workforce Reduction

• Turnstone is executing an approximately 60% reduction in its workforce. The Company expects that the combined efforts from the corporate reorganization and clinical program prioritization will extend cash runway into the second quarter of 2026.
  

Leadership Transitions

• Ines Verdon, M.D., Senior Vice President of Clinical Development, is assuming leadership of all clinical activities. Dr. Verdon joined Turnstone in 2022 and has more than 20 years of academic and pharmaceutical industry oncology and cell therapy experience. Michael Burgess, MBChB, Ph.D., is retiring as Interim Chief Medical Officer and will continue to serve as a member of the Turnstone Board of Directors.
• Michael Fitch, Ph.D., has been promoted to Senior Vice President of Manufacturing and will oversee all manufacturing and technical operations activities. Dr. Fitch joined Turnstone in 2023, bringing almost 20 years of biotechnology and pharmaceutical industry experience, including approximately a decade in cell therapy technical operations, CMC (Chemistry, Manufacturing, and Controls), and manufacturing. Vijay Chiruvolu, Ph.D., Interim Chief Technology Officer, has completed his agreed to term of service with Turnstone and is moving into a strategic advisory role for the Company.
• Wendy Worcester, CPA, current Vice President of Finance, will assume responsibility of the Finance function as the Principal Financial and Accounting Officer. Ms. Worcester joined Turnstone in 2022 and is a skilled business and finance professional with over 20 years of financial and accounting experience. Venkat Ramanan, Ph.D., will be stepping down from his role as Chief Financial Officer.
• Saryah Azmat has been promoted to Chief Operating Officer. Ms. Azmat served as the Company’s Chief Business Officer since 2021, and prior to this, as the Company’s Senior Vice President of Business Development and Corporate Strategy from 2019 to 2021.

About Turnstone

Turnstone Biologics is a clinical-stage biotechnology company developing a differentiated approach to treat and cure patients with solid tumors by pioneering selected tumor-infiltrating lymphocyte (Selected TIL) therapy. Turnstone’s next-generation TIL therapy is based upon the identification, selection and expansion of the most potent tumor-reactive T cells, known as Selected TILs, and is designed to overcome the limitations of first-generation bulk TIL that have demonstrated objective responses only in limited tumor types. Turnstone’s lead clinical program, TIDAL-01, is currently being evaluated in multiple Phase 1 studies in patients with colorectal cancer, head and neck cancer, and uveal melanoma. For additional information about Turnstone, please visit www.turnstonebio.com, and follow us on LinkedIn.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements expressed or implied in this press release include, but are not limited to, statements related to the results of the workforce reduction and leadership changes, expectations regarding any cost savings resulting from the workforce reduction, the therapeutic potential for TIDAL-01, the potential for Turnstone’s Selected TILs to efficiently select and expand tumor-reactive TILs; the potential of TIDAL-01 as a treatment option for patients with colorectal cancer, head and neck cancer and uveal melanoma, the anticipated timing of a clinical update from the Phase 1 trials of TIDAL-01, the expected cash runway, and Turnstone’s strategies and objectives. All statements, other than statements of historical fact, contained in this press release, including statements regarding future events, future financial performance, business strategy and plans, and objectives for future operations, are forward-looking statements and can be identifies by terminology such as “anticipate,” “believe,” “contemplate,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will” or “would,” or the negative of these terms or other comparable terminology. These statements are based on the current plans, objectives, estimates, expectations and intentions, beliefs and assumptions of our management team, and on information currently available to such management team and are not guarantees of future performance and inherently involve numerous risks and uncertainties, many of which are beyond Turnstone’s control. We undertake no obligation to update or revise publicly any of the forward-looking statements after the date hereof to conform the statements to actual results or changed expectations except as required by law. The reader is cautioned not to place undue reliance on forward-looking statements. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, but are not limited to, risks and uncertainties related to: impediments to the Company’s ability to execute the workforce reduction as currently contemplated, the Company’s ability to achieve projected cost savings in connection with the workforce reduction, unintended consequences from the workforce reduction that impact the Company’s business, macroeconomic conditions and the effects of global health concerns, such as global pandemics; Turnstone’s ability to initiate and execute clinical trials on the anticipated timelines, if at all; the potential for results from clinical trials to differ from preclinical, early clinical, initial, preliminary or expected results; the significant uncertainty associated with Turnstone’s product candidates ever receiving any regulatory approvals; Turnstone’s ability to obtain, maintain or protect intellectual property rights related to its product candidates; the sufficiency of Turnstone’s capital resources and need for additional capital to achieve its goals; and other risks, including those described under the heading “Risk Factors” in Turnstone’s Annual Report on Form 10-K and Quarterly Reports on Form 10-Q and other documents Turnstone has filed, or will file, with the SEC.

Contact

Ahmed Aneizi
Investor Relations
Turnstone Biologics
(347) 897-5988
ahmed.aneizi@turnstonebio.com

FAQ

What is the main focus of Turnstone Biologics' restructuring plan?

Turnstone Biologics (TSBX) is prioritizing the development of its TIDAL-01 Phase 1 program, a Selected TIL therapy for solid tumors, while reducing its workforce and streamlining operations to extend its cash runway.

How much is Turnstone Biologics (TSBX) reducing its workforce?

Turnstone Biologics is executing an approximately 60% reduction in its workforce as part of its strategic restructuring plan.

When does Turnstone Biologics (TSBX) expect to provide a clinical update on TIDAL-01?

Turnstone Biologics expects to provide a clinical update on TIDAL-01 in the first half of 2025.

How long will Turnstone Biologics' (TSBX) cash runway extend after the restructuring?

As a result of the restructuring initiatives, Turnstone Biologics' cash runway is expected to extend into the second quarter of 2026.