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CHIMERIC THERAPEUTICS LIMITED — Interim / Quarterly Report 2022
Oct 20, 2021
64648_rns_2021-10-20_ba8a51df-f063-47c1-ad19-00ae03d46a42.pdf
Interim / Quarterly Report
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Appendix 4C
Quarter Ended 30 September 2021 Chimeric Therapeutics Limited ACN 638 835 828 ASX: CHM
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21 October, 2021
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ASX Announcement
QUARTERLY ACTIVITIES REPORT FOR THE PERIOD ENDING 30 SEPTEMBER 2021
Chimeric Therapeutics (ASX:CHM, “Chimeric” or the “Company”), the ASX leader in cell therapy, is pleased to provide a summary of its activities for the quarter ended 30 September 2021.
Key highlights for the quarter included:
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Licensed novel solid tumor CAR T therapy from the world-renowned cell therapy centre, University of Pennsylvania
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IND clearance received from US FDA for CHM 1101 for Glioblastoma
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CHM 1101 data accepted for presentation at Society for Neuro-Oncology Annual Meeting
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Partnership with OncoBay Clinical for comprehensive research support to advance development of CHM 1101
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European Patent Office granted patent covering Chimeric’s CLTX CAR technology used in CHM 1101
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Jennifer Chow appointed CEO and Managing Director
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Cellular immunotherapy expert Dr George Matcham joined board of directors
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Appointed several new members to its Cellular Immunotherapy Scientific Advisory Board
CHIMERIC LICENSES NOVEL SOLID TUMOR CAR T THERAPY FROM UNIVERSITY OF PENNSYLVANIA
In late July, Chimeric entered into an exclusive licensing agreement with world renowned cell therapy centre, the University of Pennsylvania (Penn), for the first CDH17 CAR (chimeric antigen receptor) T cell therapy. Penn is a globally recognized leader in cellular immunotherapy and widely known for being home to the 1st FDA approved CAR T therapy.
The novel CDH17 CAR T cell therapy targets CDH17, a cancer target associated with poor outcomes and metastasis in neuroendocrine tumors as well as the most common gastrointestinal tumors including colorectal cancer, pancreatic cancer and gastric cancer. More than a decade of research and optimization has gone into development of the novel CDH17 CAR T cell therapy, developed by leading cellular immunotherapy scientist Professor Xianxin Hua, MD, PhD, and his team.
Preclinical studies of the CDH17 CAR T have demonstrated safety, with no toxicity to normal tissues, and promising efficacy with complete eradication of tumor cells and no relapse of the tumor.
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Development is currently underway for a phase 1 clinical trial that is planned to begin in 2022 at the University of Pennsylvania. A three-year commitment for further research and development has been made to Dr Hua and Penn.
Upfront fees associated with the license agreement will be funded entirely from existing cash reserves.
CHM 1101 (CLTX CAR T) DEVELOPMENT CONTINUES TO ADVANCE
IND clearance received
During August Chimeric announced that the US Food and Drug Administration (FDA) had cleared an Investigational New Drug (IND) application for CHM 1101 (CLTX CAR T) for patients with recurrent/relapsed Glioblastoma. With the foundational IND, Chimeric is able to open new Phase 1 sites under the current study protocol, and to advance plans for a phase 1 basket trial in solid tumours and a Phase 2 registration trial in Glioblastoma.
CHM 1101 (CLTX CAR T) is a novel CAR T cell therapy that uniquely utilizes Chlorotoxin as its tumour targeting domain. CHM 1101 has shown promising preclinical safety and efficacy and is currently being studied in a single site Phase 1 clinical trial.
CHM 1101 data accepted for presentation at SNO
To end the quarter Chimeric announced the acceptance of two CHM 1101 (CLTX CAR T) abstract presentations for the Society for Neuro-Oncology (SNO) 26th annual scientific meeting being held from November 18-21, 2021.
Clinical evaluation of the initial dose cohort in the Phase 1 clinical trial for CHM 1101 (CLTX CAR T) will be presented on Friday, November 19 within abstract CTIM-29. This abstract presentation will provide new information on the safety, and bioactivity of CHM 1101 in patients treated at the initial low dose level with intratumoral administration in the ongoing phase 1 clinical trial.
Abstract EXTH-10, to be presented on Friday November 19, will provide further insight into the mechanism by which CHM 1101 (CLTX CAR T) recognizes glioblastoma tumor cells. These novel findings continue to advance Chimeric’s understanding of the precise composition and localization of the cell surface complex recognized by CLTX CAR T.
Strategic partnership with OncoBay Clinical
Chimeric entered a strategic partnership with OncoBay Clinical to expand the clinical development program for CHM 1101 (CLTX CAR T). This will enable the expansion of the CHM
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1101 program to additional clinical trial sites and aggregate the data from all sites to prepare for the registration phase 2 program. The expansion of this program will take place under the aforementioned IND clearance from the FDA.
OncoBay Clinical is a first-of-its-kind immuno-oncology CRO specializing in complex oncology indications including cellular therapies. A boutique CRO, OncoBay Clinical is a wholly owned forprofit subsidiary of Moffitt Cancer Center.
European patent granted
The European Patent Office granted patent EP 3,362,470 B1 for CHM 1101, which was published in the European Patent Bulletin dated September 22, 2021.
The granted patent covers certain applications of chimeric antigen receptor (CAR) technology using chlorotoxin (CLTX), including Chimeric’s clinical-stage CAR T asset, CHM 1101, with patent protection expected until 2036. Chimeric holds the exclusive worldwide license to develop and commercialize EP 3,362,470 B1 and related patent applications filed in other global territories.
CHIMERIC ENHANCES KEY MANAGEMENT, BOARD, & ADVISORY BOARD PERSONNEL
In August, Chimeric was pleased to announce that Jennifer Chow, formerly COO of the Company, had been appointed CEO and Managing Director.
Ms Chow was previously Head of Global Marketing, Analytics and Commercial Operations at leading global CAR T company Kite Pharmaceuticals (acquired by Gilead Sciences in 2017 for US$12 billion). Ms Chow was responsible for assessing and prioritizing research and external assets for development, ensuring optimal clinical development of the Kite pipeline for global commercialisation.
Ms Chow has more than 20 years of commercial strategy and marketing experience focused on cellular therapy, hematology and oncology.
Early in the quarter, Dr George Matcham was appointed to the board as a Non-Executive Director. Dr Matcham brings a wealth of experience in the biopharma sector, following an instrumental three decades with cell therapy giant Celgene Corporation. He joined Celgene in its infancy in 1988 when the company was a 30-person startup, retiring in 2018 with the company turning over $15 billion annually and a staff of almost 9,000.
At Celgene Dr Matcham championed the introduction of cellular immunotherapy and led the establishment of cell therapy and biologics technical development. Vital to the growth of cell therapy at Celgene, he held several senior positions, including Chief Operations Officer of Celgene Cellular Therapeutics and Senior Vice President of CAR T CMC Development, where he oversaw clinical supply.
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With a growing pipeline of cellular immunotherapies, during the period Chimeric initiated a new Cellular Immunotherapy Scientific Advisory Board (CI-SAB) to ensure Chimeric’s development is informed by the latest scientific research as well as expert practical and clinical perspectives. The CI-SAB is being made up of world class experts who have been directly involved in the successful development of multiple cellular immunotherapies.
During the quarter, Chimeric announced the appointment of the following members of the CISAB:
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Dr Yi Lin, Mayo Clinic
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Dr Eric Smith, Dana-Farber Cancer Institute
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Dr David G Maloney, Fred Hutchinson Cancer Research Center
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Dr Michael R Bishop – University of Chicago
Financial Update
An Appendix 4C is attached to this announcement.
As detailed in the attached ASX Appendix 4C, the Company had $17.4 million in cash and equivalents as at 30 September 2021, down from $22.4 million compared to 30 June 2021. This will support the Company’s efforts to progress the development of CLTX CAR T and initiate the development of a cell therapy pipeline.
The net cash used in operating activities during the quarter was $2.5 million compared to $1.1 million for the quarter to 30 June 2021. The increase is mainly due to the 1[st] Milestone payment to City of Hope (USD 350,000).
The net cash used in investing activities during the quarter was $0.5 million. The increase of $0.5 million compared to the previous quarter relates to the upfront costs for the License Agreement with the University of Pennsylvania.
The net cash used in financing activities during the quarter was $2.0 million. The increase of $2.0 million compared to the previous quarter relates to the third instalment payment (out of six) pursuant to the City of Hope License Agreement.
In accordance with Listing Rule 4.7C, payments made to related parties and their associates included in items 6.1 of the Appendix 4C include payments for remuneration of director fees to executive and non-executive directors in the normal course of business at commercial rates, excluding reimbursements of out-of-pocket expenses.
Pursuant to Listing Rule 4.7C.2, the Company confirms that, in the 9 months since listing on the ASX, it has incurred expenditure largely in line with the Use of Proceeds set out in its Prospectus, as detailed below.
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| Use of Funds under Prospectus |
Funds allocated under Prospectus |
Funds expected allocation between admission and 30 September 2021 |
Funds expended between admission and 30 September 2021 |
Actual funds expended against Expected use of Funds period to date % |
|---|---|---|---|---|
| Offer Costs | $2,918,758 | $2,918,758 | $2,663,979* | 91% |
| Admin, Corporate and general working capital |
$5,454,318 | $4,808,917 | $5,271,302* | 110% |
| Employment | $5,714,163 | $2,587,250 | $3,095,293* | 120% |
| Licence Fees to Cityof Hope | $6,966,611 | $4,861,111 | $4,628,694* | 95% |
| Research and Development on other cancer targets |
$5,601,101 | $3,347,220 | $786,761** | 24% |
| Phase 1 clinical trial and manufacturing |
$1,875,006 | $937,503 | $0** | 0% |
| Opening new additional Phase 1 sites |
$5,000,000 | $0 | $0* | 0% |
| Other commercial and academic collaborations |
$5,000,000 | $934,000 | $596,960** | 64% |
| Total | $38,529,957 | $20,394,759 | $17,042,989 | 84% |
*Costs remain largely In line with expected use of funds.
**Costs incurred are lower than forecast. Delays in R&D due to staffing challenges during the pandemic.
Authorised on behalf of the Chimeric Therapeutics board of directors by Chairman Paul Hopper.
ABOUT CHIMERIC THERAPEUTICS
Chimeric Therapeutics, the ASX leader in cell therapy, is focused on bringing the promise of cell therapy to life for more patients with cancer. We believe that cellular therapies have the promise to cure cancer not just delay disease progression.
To bring that promise to life for more patients, Chimeric’s world class team of cell therapy pioneers and experts is focused on the discovery, development, and commercialization of the most innovative and promising cell therapies.
CHM 1101 (CLTX CAR T) is a novel and promising CAR T therapy for the treatment of patients with Glioblastoma (GBM). CHM 1101 was developed by scientists at the City of Hope Medical Centre in California where it is currently being studied in a phase 1 clinical trial.
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Chimeric also recently announced the expansion of their pipeline with the exclusive licensing of CHM 2101, a novel, 3rd generation CDH17 CAR T invented at the University of Pennsylvania. CHM 2101 (CDH17 CAR T) is currently in preclinical development with a planned phase 1 clinical trial in 2022 in Neuroendocrine Tumours, Colorectal, Pancreatic and Gastric Cancer.
Chimeric Therapeutics continues to be actively engaged in further developing its oncology pipeline with new and novel cell therapy assets that will bring the promise of cell therapy to life for more patients with cancer.
CONTACT
Investors Jennifer Chow Chief Executive Officer and Managing Director Chimeric Therapeutics T: + 1 9087238387 E: [email protected] W: www.chimerictherapeutics.com
Paul Hopper Executive Chairman T: + 61 406 671 5125
Media
Matthew Wright NWR Communications P: +61 451 896 420 E: [email protected]
Rule 4.7B
Appendix 4C
Quarterly cash flow report for entities subject to Listing Rule 4.7B
Name of entity
Chimeric Therapeutics Limited
ABN
68 638 835 828
Quarter ended (“current quarter”)
30 September 2021
| Consolidated statement of cash flows | Current quarter $A’000 |
Year to date (3 months) $A’000 |
|---|---|---|
| 1. Cash flows from operating activities 1.1 Receipts from customers 1.2 Payments for (a) research and development (b) product manufacturing and operating costs (c) advertising and marketing (d) leased assets (e) staff costs (f) administration and corporate costs 1.3 Dividends received (see note 3) 1.4 Interest received 1.5 Interest and other costs of finance paid 1.6 Income taxes paid 1.7 Government grants and tax incentives 1.8 Other (provide details if material) 1.9 Net cash from / (used in) operating activities |
- (625) - - - (1,486) (374) - 5 - - - 22 |
- (625) - - - (1,486) (374) - 5 - - - 22 |
| (2,458) | (2,458) | |
| 2. Cash flows from investing activities 2.1 Payments to acquire or for: (a) entities (b) businesses (c) property, plant and equipment (d) investments (e) intellectual property (f) other non-current assets |
- - (6) - (478) - |
- - (6) - (478) - |
ASX Listing Rules Appendix 4C (17/07/20) + See chapter 19 of the ASX Listing Rules for defined terms.
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Appendix 4C Quarterly cash flow report for entities subject to Listing Rule 4.7B
| Consolidated statement of cash flows | Consolidated statement of cash flows | Current quarter $A’000 |
Year to date (3 months) $A’000 |
|---|---|---|---|
| 2.2 Proceeds from disposal of: (a) entities (b) businesses (c) property, plant and equipment (d) investments (e) intellectual property (f) other non-current assets 2.3 Cash flows from loans to other entities 2.4 Dividends received (see note 3) 2.5 Other (provide details if material) 2.6 Net cash from / (used in) investing activities |
- - - - - - - - - |
- - - - - - - - - |
|
| (484) | (484) | ||
| 3. Cash flows from financing activities 3.1 Proceeds from issues of equity securities (excluding convertible debt securities) 3.2 Proceeds from issue of convertible debt securities 3.3 Proceeds from exercise of options 3.4 Transaction costs related to issues of equity securities or convertible debt securities 3.5 Proceeds from borrowings 3.6 Repayment of borrowings 3.7 Transaction costs related to loans and borrowings 3.8 Dividends paid 3.9 Other – repayment of debt 3.10 Net cash from / (used in) financing activities |
- - - - - - - - (2,041) |
- - - - - - - - (2,041) |
|
| (2,041) | (2,041) | ||
| 4. 4.1 4.2 4.3 |
Net increase / (decrease) in cash and cash equivalents for the period Cash and cash equivalents at beginning of period Net cash from / (used in) operating activities (item 1.9 above) Net cash from / (used in) investing activities (item 2.6 above) |
22,410 (2,458) (484) |
22,410 (2,458) (484) |
ASX Listing Rules Appendix 4C (17/07/20) + See chapter 19 of the ASX Listing Rules for defined terms.
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Appendix 4C Quarterly cash flow report for entities subject to Listing Rule 4.7B
| Consolidated statement of cash flows | Consolidated statement of cash flows | Current quarter $A’000 |
Year to date (3 months) $A’000 |
|---|---|---|---|
| 4.4 4.5 4.6 |
Net cash from / (used in) financing activities (item 3.10 above) Effect of movement in exchange rates on cash held Cash and cash equivalents at end of period |
(2,041) (6) |
(2,041) (6) |
| 17,421 | 17,421 | ||
| 5. Reconciliation of cash and cash equivalents at the end of the quarter (as shown in the consolidated statement of cash flows) to the related items in the accounts |
Current quarter $A’000 |
Previous quarter $A’000 |
|
| 5.1 Bank balances 5.2 Call deposits 5.3 Bank overdrafts 5.4 Other (provide details) 5.5 Cash and cash equivalents at end of quarter (should equal item 4.6 above) |
6,921 10,500 - - |
22,410 - - - |
|
| 17,421 | 22,410 | ||
| 6. Payments to related parties of the entity and their associates |
Current quarter $A'000 |
||
| 6.1 Aggregate amount of payments to related parties and their associates included in item 1 548 6.2 Aggregate amount of payments to related parties and their associates included in item 2 - Note: if any amounts are shown in items 6.1 or 6.2, your quarterly activity report must include a description of, and an explanation for, such payments. |
548 | ||
| - |
Item 6.1 – Include payments for remuneration of director fees to executive and non-executive directors in the normal course of business at commercial rates, excluding reimbursements of out-of-pocket expenses.
ASX Listing Rules Appendix 4C (17/07/20) + See chapter 19 of the ASX Listing Rules for defined terms.
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Appendix 4C Quarterly cash flow report for entities subject to Listing Rule 4.7B
| 7. 7.1 7.2 7.3 7.4 7.5 7.6 |
Financing facilities Note: the term “facility’ includes all forms of financing arrangements available to the entity. Add notes as necessary for an understanding of the sources of finance available to the entity. Total facility amount at quarter end $A’000 Amount drawn at quarter end $A’000 Loan facilities - - Credit standby arrangements - - Other (please specify) - - Total financing facilities - - Unused financing facilities available at quarter end - Include in the box below a description of each facility above, including the lender, interest rate, maturity date and whether it is secured or unsecured. If any additional financing facilities have been entered into or are proposed to be entered into after quarter end, include a note providing details of those facilities as well. |
Total facility amount at quarter end $A’000 |
Amount drawn at quarter end $A’000 |
|---|---|---|---|
| - | - | ||
| - | - | ||
| - | - | ||
| - | - | ||
| N/A |
| 8. | Estimated cash available for future operating activities | $A’000 |
|---|---|---|
| 8.1 8.2 8.3 8.4 8.5 8.6 |
Net cash from / (used in) operating activities (item 1.9) (2,458) Cash and cash equivalents at quarter end (item 4.6) 17,421 Unused finance facilities available at quarter end (item 7.5) - Total available funding (item 8.2 + item 8.3) 17,421 Estimated quarters of funding available (item 8.4 divided by item 8.1) 7.1 Note: if the entity has reported positive net operating cash flows in item 1.9, answer item 8.5 as “N/A”. Otherwise, a figure for the estimated quarters of funding available must be included in item 8.5. If item 8.5 is less than 2 quarters, please provide answers to the following questions: 8.6.1 Does the entity expect that it will continue to have the current level of net operating cash flows for the time being and, if not, why not? |
(2,458) 17,421 - |
| 17,421 | ||
| Answer: N/A | ||
| 8.6.2 Has the entity taken any steps, or does it propose to take any steps, to raise further cash to fund its operations and, if so, what are those steps and how likely does it believe that they will be successful? |
||
| Answer: N/A | ||
| 8.6.3 Does the entity expect to be able to continue its operations and to meet its business objectives and, if so, on what basis? |
||
| Answer: N/A | ||
| Note: where item 8.5 is less than 2 quarters, all of questions 8.6.1, 8.6.2 and 8.6.3 above must be answered. |
ASX Listing Rules Appendix 4C (17/07/20) + See chapter 19 of the ASX Listing Rules for defined terms.
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Appendix 4C Quarterly cash flow report for entities subject to Listing Rule 4.7B
Compliance statement
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1 This statement has been prepared in accordance with accounting standards and policies which comply with Listing Rule 19.11A.
-
2 This statement gives a true and fair view of the matters disclosed.
Date: 21 October 2021
Authorised by: The Board
(Name of body or officer authorising release – see note 4)
Notes
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This quarterly cash flow report and the accompanying activity report provide a basis for informing the market about the entity’s activities for the past quarter, how they have been financed and the effect this has had on its cash position. An entity that wishes to disclose additional information over and above the minimum required under the Listing Rules is encouraged to do so.
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If this quarterly cash flow report has been prepared in accordance with Australian Accounting Standards, the definitions in, and provisions of, AASB 107: Statement of Cash Flows apply to this report. If this quarterly cash flow report has been prepared in accordance with other accounting standards agreed by ASX pursuant to Listing Rule 19.11A, the corresponding equivalent standard applies to this report.
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Dividends received may be classified either as cash flows from operating activities or cash flows from investing activities, depending on the accounting policy of the entity.
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If this report has been authorised for release to the market by your board of directors, you can insert here: “By the board”. If it has been authorised for release to the market by a committee of your board of directors, you can insert here: “By the [ name of board committee – eg Audit and Risk Committee ]”. If it has been authorised for release to the market by a disclosure committee, you can insert here: “By the Disclosure Committee”.
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If this report has been authorised for release to the market by your board of directors and you wish to hold yourself out as complying with recommendation 4.2 of the ASX Corporate Governance Council’s Corporate Governance Principles and Recommendations , the board should have received a declaration from its CEO and CFO that, in their opinion, the financial records of the entity have been properly maintained, that this report complies with the appropriate accounting standards and gives a true and fair view of the cash flows of the entity, and that their opinion has been formed on the basis of a sound system of risk management and internal control which is operating effectively.
ASX Listing Rules Appendix 4C (17/07/20) + See chapter 19 of the ASX Listing Rules for defined terms.
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ASX: CHM