UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
CURRENT REPORT
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Item 7.01 Regulation FD Disclosure
On May 24, 2022, Alaunos Therapeutics, Inc.’s Chief Executive Officer, Kevin S. Boyle Sr., and Vice President of Research & Development, Drew Deniger, Ph.D., gave a presentation at the H.C. Wainwright Global Investment Conference. A copy of the presentation is furnished as Exhibit 99.1 to this Current Report on Form 8-K.
The information contained in this Item 7.01, including Exhibit 99.1, is being “furnished” and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liability of that Section or Sections 11 and 12(a)(2) of the Securities Act of 1933, as amended (the “Securities Act”). The information contained in this Item 7.01, including Exhibit 99.1, shall not be incorporated by reference into any registration statement or other document pursuant to the Securities Act or into any filing or other document pursuant to the Exchange Act, except as otherwise expressly stated in any such filing.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits.
| Exhibit No. | Description | |
| 99.1 | Presentation, dated May 2022 | |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) | |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| Alaunos Therapeutics, Inc. | ||||||
| Date. May 24, 2022 | By: | /s/ Melinda Lackey | ||||
| Name: Melinda Lackey | ||||||
| Title: Senior Vice President, Legal | ||||||
Exhibit 99.1 H.C. Wainwright Global Investment Conference May 24, 2022
Forward Looking Statements This presentation contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts, and in some cases can be identified by terms such as “may,” “will,” “could,” “expects,” “plans,” “anticipates,” “believes” or other words or terms of similar meaning. These statements include, but are not limited to, statements regarding the Alaunos Therapeutics, Inc.'s (”Alaunos or the Company ) business and strategic plans, the Company's ability to raise capital, and the timing of the Company's research and development programs, including the anticipated dates for enrolling and dosing patients in the Company’s clinical trials. Although the management team of Alaunos believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Alaunos, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward- looking information and statements. These risks and uncertainties include, among other things, changes in the Company’s operating plans that may impact its cash expenditures; the uncertainties inherent in research and development, future clinical data and analysis, including whether any of Alaunos’ product candidates will advance further in the preclinical research or clinical trial process, including receiving clearance from the U.S. Food and Drug Administration or equivalent foreign regulatory agencies to conduct clinical trials and whether and when, if at all, they will receive final approval from the U.S. Food and Drug Administration or equivalent foreign regulatory agencies and for which indication; the strength and enforceability of Alaunos’ intellectual property rights; and competition from other pharmaceutical and biotechnology companies as well as risk factors discussed or identified in the public filings with the Securities and Exchange Commission made by Alaunos, including those risks and uncertainties listed in the most recent Form 10-Q and Form 10-K filed by Alaunos with the Securities and Exchange Commission. We are providing this information as of the date of this presentation, and Alaunos does not undertake any obligation to update or revise the information contained in this presentation whether as a result of new information, future events, or any other reason. 2
Shareholder Value Creation: A Clinical Stage TCR-T Company Targeting Solid Tumors Vision 2022 – Execution Mindset, Delivering Results Phase 1/2 TCR-T Library Trial Enrolling; First patient treated April 2022, interim data 1 Weaponizing the immune expected 2H22 system with powerful TCRs to treat solid tumors 2 Clinical Library of 10 TCRs (KRAS, TP53, EGFR) Targeting Six Solid Tumor Indications Targeting driver mutations using T cells genetically modified with proprietary non-viral Sleeping Utilize internal cGMP Manufacturing Facility For TCR-T Library Trial 3 Beauty platform TM 4 Proprietary TCR Discovery Platform, hunTR , Expanding and Advancing the Pipeline 3
TCR-T Platform with Multiple Solid Tumor Programs in Pipeline PROGRAM TARGETS INDICATION DISCOVERY PRECLINICAL IND-ENABLING PHASE 1 Lung Colon/rectum Library TCR-T cell Endometrium Therapy KRAS, TP53 & EGFR Hotspot Mutations Pancreas (Company Sponsored at MDACC - NCT05194735) Ovary Bile Duct mbIL-15 KRAS & TP53 Solid Tumors TCR-T cell Therapy Hotspot Mutations Undisclosed Targets Cancer-specific Cancers with & Modalities Hotspot Mutations Somatic Mutations TM (hunTR ) 4
TCR-T is Superior to Other Cell Therapy Approaches for Solid Tumors TCR-T CAR-T TIL Target Intracellular & Extracellular Antigens Proven Efficacy in Solid Tumors Defined Target Specificity Targets Somatic Neoantigens Established Transposon-based Gene Transfer 5 Table above not based on head-to-head trials
A Differentiated TCR-T Program Targeting Solid Tumors TM Targeting Hotspot Sleeping Beauty Technology hunTR Platform (human neoantigen Mutations T cell Receptor) Non-viral transposition Hotspot mutations are ideal technology has favorable Robust discovery engine targets for safety profile enables expansion of defeating cancer TCR Library Rapid, flexible & cost- effective manufacturing 6
Our TCR-T Cell Platform Targets Solid Tumors in Large Patient Populations with Unmet Clinical Need 2022 Incidence - USA • In the US, 92% of new cancer cases Lung 236,740 are solid tumors Colon and Rectum 151,030 • 4,804 patients are diagnosed every day with cancerous solid tumor Endometrial 65,950 • 1,548 patients die every day from a Pancreas 62,210 solid tumor cancer 19,880 Ovary Bile Duct 8,000 7 7 Source: https://www.cancer.org/research/cancer-facts-statistics/all-cancer-facts-figures/cancer-facts-figures-2022.html https://www.cancer.org/cancer/bile-duct-cancer/about/key-statistics.html; CA CANCER J CLIN 2021;71:7–33
KRAS, TP53, EGFR Mutations are Commonly Expressed in Targeted Indications High frequency tumor targets, not expressed in normal tissues Killer TCR-T cells specific for the mutation without off-tumor toxicity Unmet clinical need for patients with solid tumors 8 Source: Catalogue of Somatic Mutations in Cancer (COSMIC) database https://cancer.sanger.ac.uk/cosmic
TCRs Can Give Patients' T Cells a New Ability to Recognize and Kill Tumor Cells with Common Mutations 9
TCR Library Captures High Frequency Mutations and HLA Types • Common HLAs are represented in our TCR library • Certain mutations have more than one HLA restriction • As more TCRs are added to our library, the addressable patient market size will further increase 10
Non-viral Sleeping Beauty Platform for Manufacturing TCR-T Cells without the Complexity of Gene Editing • Efficient integration without the complexity of gene editing or viral approaches • Rapid, cost-effective manufacturing • Flexible approach to add TCRs; attractive choice for library • Platform can accommodate large transgene size • Process scalable for clinical production 11
TCR-T Cells Recognize KRAS, TP53, EGFR Mutations and Kill Solid Tumor Cells Powerful TCRs: Naturally-occurring, high avidity TCRs recognize low levels of neoantigens No off-target toxicity observed: Specificity for the mutation with negligible recognition of the wild type sequences Tumor killing: Recognition of tumor cells that express mutation and HLA Note: Refers to TP53 mutant reactive TCRs 12
Actively Enrolling First-in-Human TCR-T Clinical Trial with Innovative Library Approach Trial enrolling patients where a TCR matching a neoantigen / HLA pairing is Phase I Objectives: available in our TCR-T library Define dose limiting toxicity (DLT) Phase I is a prospective, open-label, dose-escalation study of TCR-T cells in and the maximum tolerated dose patients with progressive or recurrent solid tumors who have failed standard (MTD) or recommended phase II therapy utilizing a Bayesian optimal interval design (BOIN) with an accelerated dose (RP2D) dose escalation Evaluate the feasibility of TCR-T cell 9 10 11 Patients will be enrolled in one of three dose cohorts: 5x10 , 4x10 , 1x10 drug product manufacturing 13
Alaunos Successfully Dosed its First Patient in the TCR-T Library Phase 1/2 Trial of Patients with Solid Tumors • Patient #1 has non-small cell lung cancer, and had one prior line of adjuvant therapy following surgery and three prior lines of systemic therapy • The patient has a tumor with a KRAS G12D mutation • The patient was treated at the first dose level with TCR-T cells and has now cleared the 28-day safety window • We expect to report initial data from the study in 2H 2022 14
Each Autologous TCR-T Cell Product is Manufactured with a TCR Matched for the Patient’s Mutation and HLA Type Screening 1 6 2 Selection of TCR from Library Infusion for Manufacturing 5 3 TCR Expression & Peripheral Blood Expansion Leukapheresis 4 Sleeping Beauty Transposition of TCR 15
State of the Art, In-House cGMP Manufacturing Facility Operational Provides control Located in over clinical Houston near Texas TCR-transposed T cells targeting manufacturing, including Medical Center neoantigens have been grown: expertise and scheduling with high TCR expression to clinical dose levels Staffed by highly skilled Will be used for with high viability Alaunos personnel early phase clinical manufacturing 16
TM hunTR Program Rapidly Expands TCR Library Targeting Hotspot Mutations Focus on neoantigens, particularly those arising from hotspot mutations Empirical screening of TCRs from CD4+ and CD8+ T cells directly from tumor High-throughput TCR screening 17
mbIL-15 Improves the Persistence and Anti-tumor Activity of TCR-T cells in the Tumor Microenvironment (TME) Pro-survival signaling limits negative signals from the TME Stem-cell memory mbIL-15 TCR-T cells regenerate TCR-T cells Limit effects of HLA loss by supporting TILs and NK cells Potential for TCR-T cell therapy without lymphodepletion 18 CONFIDENTIAL
Experienced Management Team Melinda Lackey Kevin S. Boyle, Sr. SVP Legal Chief Executive Officer Drew Deniger, PhD Mike Wong VP Research & Development VP Finance Melinda Lackey 19
Shareholder Value Creation: A Clinical Stage TCR-T Company Targeting Solid Tumors Vision 2022 – Execution Mindset, Delivering Results Phase 1/2 TCR-T Library Trial Enrolling; First patient treated April 2022, interim data 1 Weaponizing the immune expected 2H22 system with powerful TCRs to treat solid tumors 2 Clinical Library of 10 TCRs (KRAS, TP53, EGFR) Targeting Six Solid Tumor Indications Targeting driver mutations using T cells genetically modified with proprietary non-viral Sleeping Internal cGMP Manufacturing Facility For TCR-T Library Trial 3 Beauty platform TM 4 Proprietary TCR Discovery Platform, hunTR , Expanding and Advancing the Pipeline 20