UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
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FORM
CURRENT REPORT
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| Item 7.01. | Regulation FD Disclosure |
On January 9, 2023, Alaunos Therapeutics, Inc. (the “Company”) began using an updated corporate presentation at the 41st Annual J.P. Morgan Healthcare Conference. A copy of the presentation is furnished as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.
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 8.01. | Other Events |
On January 9, 2023, the Company issued a press release highlighting its strategic priorities and anticipated milestones for 2023. A copy of the press release is filed as Exhibit 99.2 to this Current Report on Form 8-K and is incorporated herein by reference.
| Item 9.01 | Financial Statements and Exhibits. |
(d) Exhibits.
| Exhibit No. | Description | |
| 99.1 | Corporate Presentation, dated January 2023. | |
| 99.2 | Press Release of Alaunos Therapeutics, Inc. dated January 9, 2023. | |
| 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. January 9, 2023 | By: | /s/ Melinda Lackey | ||||
| Name: Melinda Lackey | ||||||
| Title: Senior Vice President, Legal | ||||||
Exhibit 99.1 Attacking Solid Tumors with Novel TCR-T Cell Therapies January 2023
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
Delivering the Promise: Leading the Fight Against Solid Tumors with TCR-T 2022 2023 2024+ Significant Accomplishments Anticipated Milestones Building for the Future First TCR-T objective clinical Phase 2 readiness Pivotal clinical trials response in solid tumors Expand TCR library to 15 Combination therapies Doubled addressable market File IND for mbIL-15 TCR-T Treat patients with multiple TCRs Doubled manufacturing capacity ® Validated hunTR 3
Comprehensive TCR-T Platform with Multiple Solid Tumor Programs in Pipeline PROGRAM TARGETS INDICATION PRECLINICAL IND-ENABLING PHASE 1 PHASE 2 Lung KRAS G12D & G12V Colon/Rectum TP53 Endometrium Library TCR-T Cell R175H, R248W, Therapy Pancreas R273C & Y220C Ovary EGFR E746-A750del Bile Duct mbIL-15 KRAS & TP53 TCR-T Cell Solid Tumors Mutations Therapy Multiplex TCR-T Multiple targets per Solid Tumors Cell Therapy patient 4
Hotspot Mutations are Ideal Targets for TCR-T Cells to Treat Solid Tumors Target Examples Key Advantages Key Disadvantages • Drives cancer • Highly expressed targets • Hotspot Mutations Mutated EGFR, KRAS or TP53 Single targets • Not on normal tissue • Large addressable market • Small addressable market Tumor Associated NY-ESO-1, MAGE, PRAME, • Overexpressed on multiple • Potential cross reactivity with Antigens MART-1, gp100 cancer types normal tissues • Limited to few cancers • Not on normal tissues • Viral Antigens HPV, EBV, HBV Immune editing from chronic • Highly expressed target viral infection • Long time to treatment Mutations expressed by • Treatment of multiple targets• Labor intensive Individualized Mutations patient’s cancer• Large addressable market• Inherent difference between patients 5
KRAS, TP53, EGFR Mutations are Commonly Expressed in Targeted Solid Tumor Indications Nearly 2 million solid tumors cases diagnosed in United States annually High frequency tumor targets, not expressed in normal tissues These six indications represent ~600,000 new cases per year 6 Source: Most recent catalogue of Somatic Mutations in Cancer (COSMIC) database
Confirmed Responses from Leading Academic Institutions Corroborate Targeting Hotspot Mutations with TCR-T Cells Greater than 70% tumor reduction of metastatic 55% tumor reduction of metastatic breast cancer six months after infusion of TP53-R175H and HLA-A*02:01 pancreatic cancer six months after infusion of KRAS-G12D reactive TCR-T cells and HLA-C*08:02 reactive TCR-T cells Alaunos is the only company in the clinic with these TCRs 7 Sources: Leidner R et al. N Engl J Med. 2022 Jun 2;386(22):2112-2119. doi: 10.1056/NEJMoa2119662. Kim SP et al. Cancer Immunol Res. 2022 Jun 24:OF1-OF15. doi: 10.1158/2326-6066.CIR-22-0040.
Differentiated Approach to Convert Natural T-Cell Responses into TCR-T Cell Therapy for a Broad Patient Population TCR Source TCR Library Manufacture TCR-T Cell Therapy Natural TIL 1. Isolate Reactive Autologous TCR-T Response to TCR to Target A Cells Reactive to Target A Target A 2. Make Sleeping Beauty TCR Transposon 3. Add to Library of Patient 1 with Pre-Made TCRs Target A Multiple Patients with Target A 8
Unparalleled TCR Library Captures Both High Frequency Mutations and HLA Types Recently added TCRs via IND amendment: KRAS-G12V and DRB1*07:01 TP53-R273C and DPB1*04:02 Our TCR library contains mutations from genes that are known to drive cancer and are highly expressed by tumors Mutations in our library are among the most frequent and most mutated genes in solid tumors HLAs that present our mutations are prevalent in the United States 9
Non-viral Sleeping Beauty Platform Well Suited for Manufacturing TCR-T Cells without Complexity of Gene Editing • Efficient, essentially random integration without 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 • Expected to be scalable for commercialization 10 10
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 wild type sequences Tumor killing: Recognition of tumor cells that express mutation and HLA Note: Refers to TP53 mutant reactive TCRs 11
TCR-T Cell Products are Manufactured with a TCR Matched to Each Patient’s Tumor Mutation and HLA Type Screening 1 2 Selection of TCR from Infusion 7 Library for Manufacturing Formulate & 3 6 Cryopreserve Peripheral Blood Leukapheresis Sleeping Beauty 5 4 Transposition of TCR TCR Expression & Expansion 12
Universal, In-House Manufacturing Platform Delivers High Quality TCR-T Cell Products Ongoing Process Optimization Patient 1 Patient 2 Patient 3 Mutation KRAS-G12D TP53-R175H KRAS-G12V Automation and closed process steps to increase throughput Indication Lung Colorectal Pancreatic Dose Level One Two Two Reduction in overall manufacturing Viability 97% 93% 93% days and cost Total TCR-T Cells 9 Billion 64 Billion 58 Billion CD3+ Purity 99.7% 99.7% 99.1% Commercially viable process TCR+ 95% 92% 91% 13
First-in-Human TCR-T Clinical Trial Actively Enrolling with Innovative Library Approach • Defines safety and dose with any TCR and any indication Phase 1 • Enrolling in one of three dose cohorts: 5, 40 and 100 billion TCR-T cells • Defines efficacy at recommended dose with any TCR in library Phase 2 • Each cancer type will be a distinct cohort • Selected indications and selected TCRs with efficacy in Phase 2 Pivotal • IND can start while Phase 2 continues for other indications/TCRs • Multiple TCRs for use in multiple cancer types Vision for Commercial Product • Early guidance from FDA supports our approach 14
First-in-Human Confirmed Response in Solid Tumors by Sleeping Beauty TCR-T Cell Therapy SAFETY PERSISTENCE EFFICACY Manageable safety profiles Persisting TCR-T cells First TCR-T cell response in in first two dose levels (20%-30%) in blood checkpoint inhibitor refractory NSCLC No DLTs TCR-T cells trafficking to (>50% reduction) tumor No ICANs Six-month progression-free Maintenance of mutation survival comparable to and HLA post-treatment approved KRAS drug 15
Patient 1 Showed Durable, Complete Resolution of NSCLC Lesion Through Six Months Insert Image Here Insert Image Here Insert Image Here 24 0 6 12 Baseline Week 6 Week 12 Week 24 • Patient 1 had multiple lines of prior therapy and was refractory to checkpoint inhibitors • Treated with 9 billion TCR-T cells (dose level 1) targeting KRAS-G12D and HLA-A*11:01 with manageable safety profile • Confirmed partial response; patient is now off-study after six-month progression-free survival 16 Red circles represent target lesions, orange circles represent non-measurable disease
TCR-T Cells Persist in Blood and Traffic to Tumor Microenvironment Mutation and HLA were present in post-treatment tumors Patient 1: TCR-T Cell Persistence in Blood Six-month Tumor Biopsy 1 0 0 Patient 1 Patient 2 8 0 TCR-T 6.1% 6 0 TCR-T cells were detected in peripheral blood at last follow-up 4 0 2 0 0 T cells (CD3) 0 3 0 6 0 9 0 1 2 0 1 5 0 1 8 0 Tumor trafficking six months after D a y s P o s t - I n f u s i o n infusion observed 17 TCR-T cells from biopsy were grown in lab before analysis TCR-T Cells in Blood (%) TCR-T
Next Generation TCR-T Efforts Aim to Deepen Clinical Responses Augmenting TCR-T Survival Combine TCR-T and Immune Multiple TCRs infused into Checkpoint Inhibitors the Same Patient via Co-Expression of mbIL-15 Regeneration of effector Reinvigorate TCR-T cells in the Attack multiple targets on the tumor TCR-T cells in the tumor tumor microenvironment to potentially synergize TCR-T 18
® hunTR Potentially Expands TCR Library, Increases Addressable Market and Enables Multiplexed TCR-T Cell Therapy Add new HLAs to existing mutations and add 2024+ more key mutations within EGFR, KRAS, TP53 40+ TCRs 2023 Matching data from clinical efforts inform which 15 HLA/mutation combinations to prioritize TCRs >200,000 2022 10 Sleeping Beauty expected to allow for cost- effective and efficient expansion of TCR library TCRs ~60,000 for clinic ~30,000 Expect out-licensing opportunities of selected proprietary TCRs Multiple TCRs Matching 19 Potential Patients per Year
Experienced Management Team Melinda Lackey Kevin S. Boyle, Sr. SVP Legal Chief Executive Officer Drew Deniger, PhD Abhishek Srivastava, PhD Mike Wong VP Research & Development VP Technical Operations VP Finance Melinda Lackey 20
2023 Milestones Designed to Retain Our Leadership Position in TCR-T Cell Therapy for the Treatment of Solid Tumors Advance TCR-T Optimize New IND for Expand TCR Library trial to manufacturing Library to 15 TCRs mbIL-15 TCR-T Phase 2 process towards commercial Translational scalability assessment-driven next gen TCR-T 21
Exhibit 99.2
Alaunos Therapeutics Highlights Strategic Priorities and Anticipated Portfolio Milestones for 2023
| • | Announcing addition of two new TCRs to the library, estimated to double the addressable market; plans to further expand TCR library using hunTR® TCR discovery platform |
| • | Increasing patient enrollment to advance TCR-T Library Program towards Phase 2 using high value TCRs targeting common hotspot mutations in six solid tumor indications |
| • | Executing against multi-pronged strategy to expand and optimize manufacturing capabilities and processes towards commercial scalability |
| • | Advancing our mbIL-15 program towards an anticipated IND filing in the second half of 2023 |
HOUSTON, January 9, 2022 – Alaunos Therapeutics, Inc. (“Alaunos” or the “Company”) (Nasdaq: TCRT), a clinical-stage oncology-focused cell therapy company today highlights its expected milestones and strategic priorities for 2023.
“Achieving the first-in-human objective clinical response in a patient with a solid tumor using a non-viral TCR-T cell therapy made for an exciting 2022. We believe we are well positioned to increase the pace of enrollment in 2023 and with the addition of two new TCRs to our library we have doubled the potential addressable market of our therapy,” commented Kevin S. Boyle, Sr., Chief Executive Officer of Alaunos. “In December we treated our third patient, a pancreatic patient, with a KRAS-G12V mutation. The year ahead will focus on increasing patient enrollment with an aim towards advancing the program to Phase 2 readiness. We are excited about our progress to date and as leaders in the TCR-T cell therapy space we look forward to bringing the promise of our therapies to even more patients in need.”
Anticipated 2023 Milestones and Strategic Priorities
Expand TCR library using hunTR® TCR discovery platform to increases addressable market: In the fourth quarter of 2022, the Company submitted an IND amendment to the U.S. Food and Drug Administration (FDA) adding two new TCRs to its clinical trial targeting frequent mutations and HLAs, with the potential to double the addressable market of its TCR-T program. The addition of these new TCRs highlights our strategy to add both more HLAs to existing mutations (KRAS-G12V and HLA-DRB1*07:01) and new mutations within our targeted gene families (TP53-R273C and HLA-DPB1*04:02). In 2023, the Company expects to further expand its library with exclusively owned TCRs targeting recurrent hotspot mutations in KRAS, TP53 and EGFR.
Advance TCR-T library program to Phase 2 readiness: The Company continues to actively enroll patients in its TCR-T Library Phase 1/2 trial targeting KRAS, TP53, and EGFR hotspot mutations across six solid tumor indications. In September 2022, the Company announced the first objective clinical response from a TCR-T cell therapy using non-viral Sleeping Beauty targeting solid tumors. The Company successfully dosed its third patient in the trial in December 2022 and expects to enroll multiple patients in the first half of 2023. Alaunos anticipates providing an interim data update by mid-2023 as it works towards advancing the program into Phase 2.
Optimize manufacturing process towards commercial scalability: The Company continues to execute on its multi-pronged strategy to expand manufacturing capacity and efficiency. The Company doubled its manufacturing capacity in 2022 allowing for production of two products simultaneously. The Company also filed an IND amendment to move from fresh to cryopreserved product and expects to begin implementing this change in the first half of 2023. The use of cryopreserved cell products will reduce manufacturing process time from 30 days to 26 days, a 13% decrease, while increasing flexibility for patient scheduling and treatment. The Company has ongoing initiatives to optimize the process and further reduce the manufacturing time.
Explore next generation TCR-T cell therapy approaches to deepen clinical responses: The Company is advancing its mbIL-15 TCR-T cell therapy program towards an IND filing anticipated in the second half of 2023. The Company believes mbIL-15 has the potential to increase the survival of TCR-T cells in the harsh tumor microenvironment and deepen clinical responses. In addition, Alaunos continues to conduct translational assessments of treated patients to guide next generation TCR-T therapy approaches including potential combination and multiplexed TCR-T cell therapies.
Cash Position and Financial Guidance
Alaunos ended the fourth quarter of 2022 with unaudited cash and cash equivalents of approximately $39.1 million and restricted cash of approximately $13.9 million. Based on current operating plans, the Company expects its operating cash flow for 2023 to be between approximately $35 million and $40 million. The Company expects to have sufficient cash resources to fund research and development programs and operations into Q4 2023.
About Alaunos Therapeutics
Alaunos is a clinical-stage oncology-focused cell therapy company, focused on developing T cell receptor (TCR) therapies based on its proprietary, non-viral Sleeping Beauty gene transfer technology and its TCR library targeting shared tumor-specific hotspot mutations in key oncogenic genes including KRAS, TP53 and EGFR. The Company has a clinical and strategic collaboration with the National Cancer Institute.
Forward-Looking Statements Disclaimer
This press release 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 Company’s business and strategic plans, the anticipated outcome of preclinical and clinical studies by the Company or its third-party collaborators, the Company’s cash runway and forecast operating cash flow, the Company’s manufacturing capabilities and the timing of the Company’s research and development programs, including the expected timeline for enrolling and dosing patients, submitting and receiving approvals on INDs and similar regulatory submissions and the timing and forums for announcing data from 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 periodic report filed by Alaunos with the Securities and Exchange Commission. Alaunos is providing this information as of the date of this press release, and Alaunos does not undertake any obligation to update or revise the information contained in this press release whether as a result of new information, future events, or any other reason.
Investor Relations Contact:
Alex Lobo
Stern Investor Relations
Alex.lobo@sternir.com