UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
CURRENT REPORT
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): January 26, 2022 (
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If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Item 5.03 Amendments to Articles of Incorporation or Bylaws; Change in Fiscal Year.
Effective January 25, 2022, ZIOPHARM Oncology, Inc. changed its name (the “Name Change”) to Alaunos Therapeutics, Inc. (the “Company”). The Name Change was effected following approval by the Company’s Board of Directors through the filing of a Certificate of Amendment to the Company’s Amended and Restated Certificate of Incorporation. A copy of the Certificate of Amendment is filed as Exhibit 3.1 to this Current Report on Form 8-K and is incorporated herein by reference.
Item 7.01 Regulation FD Disclosure
On January 26, 2022, representatives of the Company presented slides with a business update. A copy of the presentation is furnished as Exhibit 99.1 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 26, 2022, the Company issued a press release announcing certain corporate and operational updates, including the opening of the Company’s Phase 1/2 T-cell receptor T cell therapy (TCR-T) Library trial for enrollment and the Name Change. The press release also announced that the Company’s common stock would begin trading under the symbol “TCRT” on The Nasdaq Global Select Market, effective January 27, 2022. 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.
In connection with the Name Change, the Company launched a new corporate website: www.alaunos.com. The Company’s investor relations information, including press releases and links to the Company’s filings with the Securities and Exchange Commission (the “SEC”), will now be found on this website. The Company’s SEC filings and the Company’s corporate governance documents, including the charters of the committees of the Company’s Board of Directors and Code of Ethics and Business Conduct, are available on this website. Any amendments to or waivers of the Company’s Code of Ethics and Business Conduct will be disclosed on this website.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits.
| Exhibit No. | Description | |
| 3.1 | Certificate of Amendment, dated January 25, 2022 | |
| 99.1 | Presentation, dated January 2022 | |
| 99.2 | Press release, dated January 26, 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: January 26, 2022 | By: | /s/ Kevin S. Boyle, Sr. | ||||
| Name: Kevin S. Boyle, Sr. | ||||||
| Title: Chief Executive Officer | ||||||
Exhibit 3.1
CERTIFICATE OF AMENDMENT
OF THE
AMENDED AND RESTATED CERTIFICATE OF INCORPORATION
OF
ZIOPHARM ONCOLOGY, INC.
ZIOPHARM Oncology, Inc. (the “Corporation”), a corporation organized and existing under and by virtue of the provisions of the General Corporation Law of the State of Delaware (the “General Corporation Law”),
DOES HEREBY CERTIFY:
1. The name of the Corporation is ZIOPHARM Oncology, Inc., formerly known as EasyWeb, Inc. The date of filing of its original Certificate of Incorporation with the Secretary of State was May 16, 2005.
2. This Certificate of Amendment amends the provisions of the Corporation’s Amended and Restated Certificate of Incorporation filed with the Secretary of State on April 26, 2006, as amended (the “Certificate of Incorporation”).
3. Article 1 of the Certificate of Incorporation is hereby amended and restated to read as follows:
| “1. | Name. The name of the corporation is Alaunos Therapeutics, Inc. (the “Corporation”).” |
4. This Certificate of Amendment has been duly adopted in accordance with the provisions of Section 242 of the General Corporation Law.
5. All other provisions of the Certificate of Incorporation shall remain in full force and effect.
[Remainder of page intentionally blank]
IN WITNESS WHEREOF, this Corporation has caused this Certificate of Amendment to be signed by its Chief Executive Officer this 25th day of January, 2022.
| /s/ Kevin S. Boyle, Sr. | ||
| Name: | Kevin S. Boyle, Sr. | |
| Title: | Chief Executive Officer | |
Exhibit 99.1 Attacking Solid Tumors with Novel TCR-T Cell Therapies January 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; FPI anticipated 1H22, interim data expected 1 Weaponizing the 2H22 immune system with powerful TCRs to treat 2 Clinical Library of 10 TCRs (KRAS, TP53, EGFR) Targeting Six Solid Tumor Indications solid tumors Targeting driver mutations Utilize internal cGMP Manufacturing Facility For TCR-T Library Trial 3 using T cells genetically modified with proprietary non- viral Sleeping Beauty platform TM 4 Proprietary TCR Discovery Platform, hunTR , Expanding and Advancing the Pipeline 3
From Ziopharm to Alaunos: Focused and Executing on Advancing our Novel TCR-T Platform February 2021 August 2021 October 2021 December 2021 Library Trial IND Clear to Kevin S. Boyle, Sr. Completed manufacturing Consolidated Proceed & Appointed CEO process qualification in Operations to Houston Departure of Laurence Company’s GMP facility January 2022 Cooper as CEO Trial Open for Enrollment & cGMP facility operational January 2022 Rebranding December 2021 to Alaunos Added four new targets to TCR-T Library & Renegotiated SVB loan November 2021 May 2021 September 2021 CAR-T JV (Eden IL-12 Winddown Strategic Restructuring BioCell) Winddown 4
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) 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 ) 5
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 6 Table above not based on head-to-head trials
A Differentiated TCR-T Program Targeting Solid Tumors TM Targeting Hotspot Sleeping Beauty hunTR Platform (human neoantigen Mutations Technology T cell Receptor) Hotspot mutations are Non-viral transposition Robust discovery engine ideal targets for technology has favorable enables expansion of defeating cancer safety profile TCR Library Rapid, flexible & cost- effective manufacturing 7
Our TCR-T Cell Platform Targets Solid Tumors in Large Patient Populations with Unmet Clinical Need Cancer Type 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 65,950 Endometrial • 1,548 patients die every day from a Pancreas 62,210 solid tumor cancer Ovary 19,880 Bile Duct 8,000 8 8 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 9 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 10
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 11
Non-viral Sleeping Beauty Platform for Manufacturing TCR- T Cells • 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 12
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 13
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 available in Phase I Objectives: our TCR-T library. Define dose limiting toxicity (DLT) and Phase I is a prospective, open-label, dose-escalation study of TCR-T cells in patients the maximum tolerated dose (MTD) or with progressive or recurrent solid tumors who have failed standard therapy utilizing a recommended phase II dose (RP2D). Bayesian optimal interval design (BOIN) with an accelerated dose escalation. Evaluate the feasibility of TCR-T cell Patients will be enrolled in one of three dose cohorts. drug product manufacturing. Expect to dose first patient in 1H 2022 (NCT05194735). Phase II (Dose Expansion) is a prospective, open-label, single-dose portion of the study which is expected to begin once the MTD/RP2D in the Phase I part has been determined. 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 Infusion Library 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 can be Co-expressed with TCRs 18
Experienced Management Team Kevin S. Boyle, Sr. Ellee de Groot, PhD Raffaele Baffa, MD, PhD Chief Executive Officer EVP Operations Chief Medical Officer Melinda Lackey Drew Deniger, PhD Mike Wong SVP Legal 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; FPI anticipated 1H22, interim data expected 1 Weaponizing the 2H22 immune system with powerful TCRs to treat 2 Clinical Library of 10 TCRs (KRAS, TP53, EGFR) Targeting Six Solid Tumor Indications solid tumors Targeting driver mutations Internal cGMP Manufacturing Facility For TCR-T Library Trial 3 using T cells genetically modified with proprietary non- viral Sleeping Beauty platform TM 4 Proprietary TCR Discovery Platform, hunTR , Expanding and Advancing the Pipeline 20
Exhibit 99.2
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Ziopharm Oncology Highlights Operational Progress & Rebrands to Alaunos Therapeutics
| • | Phase 1/2 TCR-T Library trial targeting KRAS, TP53 and EGFR mutations across six solid tumor indications is open for enrollment; continue to expect to dose the first patient in 1H 2022 |
| • | Phase 1/2 IND amended to include four additional TCRs, bringing the total number of evaluable TCRs to 10, further expanding number of eligible patients |
| • | In-house cGMP manufacturing facility is operational to support internal clinical development programs |
| • | Company changes name to Alaunos Therapeutics reflecting renewed focus |
HOUSTON, January 26, 2022 — Ziopharm Oncology, Inc. (“Ziopharm” or the “Company”) (Nasdaq: ZIOP), a clinical-stage oncology-focused cell therapy company, today highlighted recent operational and corporate updates. The Company also announced that it has changed its name to Alaunos Therapeutics, Inc. (“Alaunos” or the “Company”).
“We are very pleased to announce that our Phase 1/2 TCR-T library trial is now open for enrollment at MD Anderson Cancer Center. This first of its kind study, enabled by our versatile non-viral Sleeping Beauty technology, will allow us to efficiently target six solid tumor indications within this single clinical trial. In addition, our R&D efforts continue to bear fruit and we amended our IND to include four additional TCRs to the study. This further increases the number of eligible patients who could benefit from our therapies, and we look forward to dosing the first patient in this study within the first half of this year. Lastly, to support our clinical development, we have successfully opened our cGMP manufacturing facility and we are now able to manufacture our autologous cell therapy products in-house,” commented Kevin S. Boyle, Sr., Chief Executive Officer.
“Over the course of 2022, the team will continue to work diligently with an execution mindset to deliver results. In addition to translating groundbreaking science into meaningful clinical progress we will work to advance our membrane bound IL-15 program with IND enabling studies. Our name change to Alaunos Therapeutics reflects the completion of our transition to a TCR-T focused company and embodies our mission of developing novel therapies for cancer patients,” concluded Mr. Boyle.
Operational Updates
| • | Phase 1/2 TCR-T Library Program Open for Enrollment: Alaunos’ phase 1/2 clinical trial is evaluating library TCR-T shared hotspot neoantigens using the Company’s Sleeping Beauty transposon/transposase technology. The Company added four additional T-cell receptors (TCRs) to its library, further increasing the number of eligible patients for the clinical trial. The study being conducted |
| at MD Anderson Cancer Center is an open label, dose escalation study that will enroll patients who have a matched HLA and hotspot mutation that is a targeted by one of the 10 TCRs from the Alaunos library. The trial will evaluate 10 unique TCRs targeting KRAS, TP53 and EGFR mutations in patients across a broad range of solid tumors that include non-small cell lung, colorectal, endometrial, pancreatic, ovarian, and bile duct cancers, all in a single trial. The Phase 1 primary endpoint is maximum tolerated dose or recommended phase 2 dose. The Company expects to dose the first patient in the first half of 2022 and to provide an interim data update later this year. Additional information about the study is available at www.clinicaltrials.gov using the identifier: NCT05194735. |
| • | In-House cGMP Manufacturing Facility Operational: Alaunos completed the qualification of its state-of-the-art good manufacturing practice (cGMP) TCR manufacturing facility near the Texas Medical Center in Houston. The facility is staffed by Alaunos personnel and is fully operational for the manufacture and release of clinical product. |
| • | hunTR™ (human neoantigen T-cell Receptor) Platform for TCR Discovery: Alaunos’ TCR hunting process, hunTR™, enables the rapid identification of new and proprietary TCRs from CD4+ and CD8+ T cells to further expand the Company’s growing TCR-T library. The platform can evaluate thousands of single T cells simultaneously using state-of-the-art bioinformatics and next generation sequencing to identify TCRs specific for neoantigens that arise from hotspot mutations. The proprietary high-throughput TCR screening process permits rapid functional validation of TCRs. Newly discovered neoantigen-specific TCRs will then undergo further development required to potentially qualify the TCR for inclusion in the Company’s TCR library and clinical evaluation. |
Corporate Updates
| • | Name Change to Alaunos Therapeutics, Inc.: The name Alaunos originates from the Celtic mythological god of healing, reflecting the Company’s commitment to developing therapies for cancer patients. The Company will trade on The Nasdaq Stock Market under the new ticker symbol “TCRT”, to be effective at market open on January 27, 2022. In conjunction with the corporate name change, the Company has launched a new website, www.alaunos.com, which contains information about the Company and its innovative TCR-T platform. |
| • | Closure of Boston, MA Location: To streamline operations, the Company has closed its Boston office. Alaunos will be headquartered in Houston. |
About Alaunos Therapeutics, Inc.
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 platform and its unique cancer mutation hotspot TCR library, targeting common tumor-related mutations in key oncogenic genes including KRAS, TP53 and EGFR. The Company has clinical and strategic collaborations with The University of Texas MD Anderson Cancer Center and the National Cancer Institute. For more information, please visit www.alaunos.com.
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 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. 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