Initial Activity in Head and Neck Cancer Demonstrated in NT219 Phase 1/2Dose Escalation Study
Patients’Enrollment in the Phase 2 Randomized CM24 Pancreatic CancerTrial Ahead of Timelines
Cash Runway Extended to 2H 2025 through Recent Financing
"We are pleased to report that we expect to complete patient enrollment in our Phase 2 randomized CM24 pancreatic cancer study soon, ahead of our previous plan and that might result in earlier than anticipated analysis of interim and top line overall survival (OS) data during 2024. The interim data look will occur in 2024 when sufficient progression free survival (PFS) and OS events are registered and enable a meaningful data interpretation for a larger number of patients. Recently reported biomarker data demonstrates CM24’s mechanism of action for this important indication in dire need of a more effective drug that prolongs survival,” stated
“Our Phase 1/2 dose escalation study of NT219 in head and neck cancer demonstrated initial activity at the dose level of 50 mg/kg. We continue dose optimization at a higher dose level and expect to report additional data during the first half of 2024 in parallel to preparing to enter a Phase 2 study.”
“With a cash runway that extends more than two years, through the second half of 2025,
Q3 2023 and Recent Corporate Highlights:
- CM24 Pancreatic Cancer Program Advances
- Phase 2 enrollment ahead of schedule
- Interim results for PFS and OS expected in H1 2024 with topline results expected in H2 2024
- Biomarker data supporting MOA presented at AACR
Patient enrollment in the Phase 2 study of CM24 was accelerated and the Company’s plan to enroll approximately 60 patients is expected to be completed soon, ahead of schedule. Since OS and PFS are event-based endpoints, a meaningful estimate of the endpoint can be achieved once sufficient events occur in the study arms. We expected this to happen in 2024 when enough PFS and OS events are registered and enable meaningful data interpretation for a larger number of patients. The acceleration allows the Company to reduce the total cost of the trial and to report, possibly earlier than expected, an interim OS analysis, the study’s primary endpoint, together with the analysis of PFS during 1H 2024. The randomized Phase 2 study (NCT04731467), in clinical collaboration with
New biomarker data for CM24 were presented at the
- NT219 Positive Phase 1/2 Interim Results in Head & Neck Cancer
- Anti-tumor activity with confirmed partial responses in highest, to date, dose cohort
- Phase 2 study is being designed
- Fortified IP protection with new patent
Initial anti-tumor activity was demonstrated at the 50mg/kg dose level of NT219 at 50mg/kg in combination with cetuximab in the Phase 1 dose escalation study. A dose-dependent increase in drug exposure of NT219 was reported and target engagement was observed in tumor samples, with 2 of the 4 evaluable recurrent and metastatic squamous cell carcinoma of the head and neck patients dosed at 50mg/kg demonstrated confirmed partial response.
A new patent was granted in
Financial Results for the three Months Ended
Research and Development Expenses were
Selling, General and Administrative Expenses were
Operating Loss was
On a non-IFRS basis (as reconciled below), adjusted operating loss was
Net Loss for the three months ended
Financial Results for the Nine Months Ended
Research and Development Expenses were
Selling, General and Administrative Expenses were
Operating Loss was
On a non-IFRS basis (as reconciled below), adjusted operating loss was
Net Loss for the nine months ended
As of
During the nine months ended
Non-IFRS Financial Measures.
This press release includes information about certain financial measures that are not prepared in accordance with International Financial Reporting Standards ("IFRS"), including adjusted operating loss and adjusted net loss. These non-IFRS measures are not based on any standardized methodology prescribed by IFRS and are not necessarily comparable to similar measures presented by other companies. Adjusted operating loss and adjusted net loss adjust for share-based compensation expenses. The Company's management and board of directors utilize these non-IFRS financial measures to evaluate the Company's performance. The Company provides these non- IFRS measures of the Company's performance to investors because its management believes that these non- IFRS financial measures, when viewed with the Company's results under IFRS and the accompanying reconciliations, are useful in identifying underlying trends in ongoing operations. However, these non- IFRS measures are not measures of financial performance under IFRS and, accordingly, should not be considered as alternatives to IFRS measures as indicators of operating performance. Further, these non-IFRS measures should not be considered measures of the Company's liquidity. A reconciliation of certain IFRS to non-IFRS financial measures has been provided in the tables included in this press release.
About
Forward-Looking Statements and Safe Harbor Statement
Certain statements in this press release that are forward-looking and not statements of historical fact are forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include, but are not limited to, statements that are not statements of historical fact, and may be identified by words such as "believe", "expect", "intend", "plan", "may", "should", "could", "might", "seek", "target", "will", "project", "forecast", "continue" or "anticipate" or their negatives or variations of these words or other comparable words or by the fact that these statements do not relate strictly to historical matters. You should not place undue reliance on these forward-looking statements, which are not guarantees of future performance. Forward-looking statements reflect our current views, expectations, beliefs or intentions with respect to future events, and are subject to a number of assumptions, involve known and unknown risks, many of which are beyond our control, as well as uncertainties and other factors that may cause our actual results, performance or achievements to be significantly different from any future results, performance or achievements expressed or implied by the forward-looking statements. Important factors that could cause or contribute to such differences include, among others, risks relating to: the plans, strategies and objectives of management for future operations; product development for NT219, CM24 and IM1240; the process by which such early stage therapeutic candidates could potentially lead to an approved drug product is long and subject to highly significant risks, particularly with respect to a joint development collaboration; the fact that drug development and commercialization involves a lengthy and expensive process with uncertain outcomes; our ability to successfully develop and commercialize our pharmaceutical products; the expense, length, progress and results of any clinical trials; the impact of any changes in regulation and legislation that could affect the pharmaceutical industry; the difficulty in receiving the regulatory approvals necessary in order to commercialize our products; the difficulty of predicting actions of the
CONTACTS:
Company Contact:
Chief Financial Officer
IR@purple-biotech.com
Consolidated Unaudited Statements of Financial Position as of:
2023 | 2022 | |||||
USD thousand | USD thousand | |||||
Assets | ||||||
Cash and cash equivalents | 15,104 | 15,030 | ||||
Short term deposits | 842 | 16,652 | ||||
Other investments | 138 | 431 | ||||
Other current assets | 634 | 1,143 | ||||
Total current assets | 16,718 | 33,256 | ||||
Non-current assets | ||||||
Right of use assets | 354 | 467 | ||||
Fixed assets, net | 156 | 215 | ||||
Intangible assets | 28,044 | 20,684 | ||||
Total non–current assets | 28,554 | 21,366 | ||||
Total assets | 45,272 | 54,622 | ||||
Liabilities | ||||||
Lease liability - short term | 178 | 194 | ||||
Accounts payable | 2,593 | 2,132 | ||||
Other payables | 3,449 | 4,732 | ||||
Total current liabilities | 6,220 | 7,058 | ||||
Non-current liabilities | ||||||
Lease liability | 192 | 321 | ||||
Post-employment benefit liabilities | 141 | 145 | ||||
Total non-current liabilities | 333 | 466 | ||||
Equity | ||||||
Share capital, no par value | - | - | ||||
Share premium | 133,024 | 126,407 | ||||
Receipts on account of warrants | 28,017 | 28,017 | ||||
Capital reserve for share-based payments | 10,284 | 10,164 | ||||
Capital reserve from transactions with related parties | 761 | 761 | ||||
Capital reserves from hedging | (2 | ) | (6 | ) | ||
Capital reserve from transactions with non-controlling | ||||||
interest | (859 | ) | (859 | ) | ||
Accumulated loss | (132,627 | ) | (117,573 | ) | ||
Equity attributable to owners of the Company | 38,598 | 46,911 | ||||
Non-controlling interests | 121 | 187 | ||||
Total equity | 38,719 | 47,098 | ||||
Total liabilities and equity | 45,272 | 54,622 | ||||
Consolidated Unaudited Statement of Operations for the nine and three months ended September 30, 2023
For the nine months ended | For the three months ended | ||||||||||||
2023 | 2022 | 2023 | 2022 | ||||||||||
USD thousand | USD thousand | USD thousand | USD thousand | ||||||||||
Research and development expenses | 11,792 | 11,500 | 4,589 | 3,465 | |||||||||
Sales, general and administrative expenses | 4,212 | 4,502 | 1,158 | 1,616 | |||||||||
Operating loss | 16,004 | 16,002 | 5,747 | 5,081 | |||||||||
Finance expense | 223 | 108 | 16 | 16 | |||||||||
Finance income | (1,109 | ) | (393 | ) | (708 | ) | (248 | ) | |||||
Finance expense (income), net | (886 | ) | (285 | ) | (692 | ) | (232 | ) | |||||
Loss for the period | 15,118 | 15,717 | 5,055 | 4,849 | |||||||||
Other Comprehensive Loss: | |||||||||||||
Items that will be transferred to profit | |||||||||||||
or loss: | |||||||||||||
Loss (Profit) on cash flow hedges | (4 | ) | 17 | - | (4 | ) | |||||||
Total comprehensive loss for the period | 15,114 | 15,734 | 5,055 | 4,845 | |||||||||
Loss attributable to: | |||||||||||||
Owners of the Company | 15,052 | 15,657 | 5,036 | 4,824 | |||||||||
Non-controlling interests | 66 | 60 | 19 | 25 | |||||||||
15,118 | 15,717 | 5,055 | 4,849 | ||||||||||
Total comprehensive loss attributable to | |||||||||||||
Owners of the Company | 15,048 | 15,674 | 5,036 | 4,820 | |||||||||
Non-controlling interests | 66 | 60 | 19 | 25 | |||||||||
15,114 | 15,734 | 5,055 | 4,845 | ||||||||||
Loss per share data | |||||||||||||
Basic and diluted loss per ADS - USD | 0.72 | 0.87 | 0.23 | 0.27 | |||||||||
Number of ADSs used in calculation | 20,901,078 | 17,977,244 | 21,836,454 | 18,073,331 | |||||||||
Reconciliation of Adjusted Operating Loss
For the nine months ended September 30, | For the three months ended September 30, | ||||||||||||
2023 | 2022 | 2023 | 2022 | ||||||||||
USD | USD | USD | USD | ||||||||||
Operating loss for the period | 16,004 | 16,002 | 5,747 | 5,081 | |||||||||
Less ESOP expenses | (1,694 | ) | (1,573 | ) | (449 | ) | (707 | ) | |||||
14,310 | 14,429 | 5,298 | 4,374 | ||||||||||
Reconciliation of Adjusted Net Loss
For the nine months ended | For the three months ended | ||||||||||||
2023 | 2022 | 2023 | 2022 | ||||||||||
USD | USD | USD | USD | ||||||||||
Loss for the period | 15,118 | 15,717 | 5,055 | 4,849 | |||||||||
Less ESOP expenses | (1,694 | ) | (1,573 | ) | (449 | ) | (707 | ) | |||||
13,424 | 14,144 | 4,606 | 4,142 | ||||||||||
Consolidated Unaudited Statements of Cash Flow
For the nine months ended | |||||
2023 | 2022 | ||||
USD thousand | USD thousand | ||||
Cash flows from operating activities: | |||||
Loss for the period | (15,118 | ) | (15,717 | ) | |
Adjustments: | |||||
Depreciation | 149 | 151 | |||
Finance income, net | (886 | ) | (285 | ) | |
Share-based payments | 1,694 | 1,573 | |||
(14,161 | ) | (14,278 | ) | ||
Changes in assets and liabilities: | |||||
Changes in other investments and other current assets | 219 | (124 | ) | ||
Changes in accounts payables | 415 | 1,534 | |||
Changes in other payables | (1,255 | ) | 495 | ||
Changes in post-employment benefit liabilities | (161 | ) | (148 | ) | |
(782 | ) | 1,757 | |||
Net cash used in operating activities | (14,943 | ) | (12,521 | ) | |
Cash flows from investing activities: | |||||
Acquisition of subsidiary, net of cash acquired | (3,549 | ) | - | ||
Proceed from other investments | 875 | - | |||
Acquisition of intangible asset | - | (202 | ) | ||
Interest received | 675 | 324 | |||
Decrease (increase) in short-term deposits | 15,809 | (2,481 | ) | ||
Decrease in long-term deposits | - | 14,300 | |||
Acquisition of fixed assets | (3 | ) | (26 | ) | |
Net cash provided by investing activities | 13,807 | 11,915 | |||
Cash flows from financing activities: | |||||
Proceeds from issuance ADSs | 1,559 | 1,312 | |||
ADS issuance expenses paid | (188 | ) | (114 | ) | |
Repayment of lease liability | (126 | ) | (124 | ) | |
Interest paid | (42 | ) | (49 | ) | |
Net cash provided by financing activities | 1,203 | 1,025 | |||
Net increase in cash and cash equivalents | 67 | 419 | |||
Cash and cash equivalents at the beginning of the period | 15,030 | 10,890 | |||
Effect of translation adjustments on cash and cash equivalents | 7 | (235 | ) | ||
Cash and cash equivalents at the end of the period | 15,104 | 11,074 | |||
Source:
2023 GlobeNewswire, Inc., source