“Our two lead oncology candidates, CM24 and NT219, designed to overcome tumor immune evasion, made significant clinical progress over the past year in difficult to treat indications, positioning them well as potential second line treatments in pancreatic and head and neck cancer. The acquisition last year of our conditionally activated T cells and NK cell engagers platform strongly positions us with a very promising and differentiated approach to cancer treatment, as multi-specifics have garnered increasing industry attention. We look ahead to key data read outs in 2024, backed by a cash runway to take us well into the first half of 2025,” stated
2023 and Recent Clinical & Corporate Highlights:
- CM24 as 2nd Line Treatment for Pancreatic Ductal Adenocarcinoma (PDAC) Data Upcoming
- Phase 2 PDAC study completed enrollment ahead of schedule in 2023
- Interim data expected H1 2024 and topline data expected H2 2024
- CM24 biomarker data presented at AACR support PDAC indication
The Company’s Phase 2 study for CM24, a multi-functional immune checkpoint inhibitor, dosed its first PDAC patient in
The primary endpoint is overall survival (OS). Interim data are expected in H1 2024, with topline data expected to follow in H2 2024.
At the
- NT219 as 2nd Line Treatment for Recurrent and/or Metastatic Squamous Cell Carcinoma of the Head and Neck (R/M SCCHN) Phase 2 is Planned
- R/M SCCHN positive results reported at
ESMO-TAT Congress 2024 from Phase 1 study demonstrating NT219 activity and safety profile - Recommended Phase 2 Dose achieved; Phase 2 study is planned to commence in H1 2024
- Preclinical data reported at AACR supports synergy with checkpoint inhibitors
- R/M SCCHN positive results reported at
In a Phase 1 dose escalation study (NCT04474470) of NT219, a first-in-class small molecule dual inhibitor of
A Phase 2 study of NT219 in combination with cetuximab as a second line treatment for R/M SCCHN is planned to commence in H1 2024. The Company is supported by its newly formed
At the AACR Annual Meeting 2023 in
- Tri-Specific Conditionally Activated Immuno-Engagers Oncology Platform Acquired
- First asset expected to be IND ready in approximately two years
- Lead tribody target 5T4 is highly expressed in multiple cancers
- Preclinical data validate cancer cell killing effect
In
Financial Results for the Year Ended
Research and Development Expenses were
Selling, General and Administrative Expenses were
Operating Loss was
Finance income for 2023 was
On a non-IFRS basis (as reconciled below), adjusted operating loss was
Net Loss for 2023 was
As of
During the year ended
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
Finance income for the three months ended
Net Loss for the three 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 Statements of Financial Position as of | |||||||
2023 | 2022 | ||||||
USD thousands | USD thousands | ||||||
Assets | |||||||
Cash and cash equivalents | 14,489 | 15,030 | |||||
Short term deposits | 850 | 16,652 | |||||
Other investments | 73 | 431 | |||||
Other current assets | 376 | 1,143 | |||||
Total current assets | 15,788 | 33,256 | |||||
Non-current assets | |||||||
Right to use assets | 316 | 467 | |||||
Fixed assets, net | 154 | 215 | |||||
Intangible assets | 28,044 | 20,684 | |||||
Total non - current assets | 28,514 | 21,366 | |||||
Total assets | 44,302 | 54,622 | |||||
Liabilities | |||||||
Current maturity of lease liability | 188 | 194 | |||||
Trade payable | 3,532 | 2,132 | |||||
Other payables | 3,463 | 4,732 | |||||
Total current liabilities | 7,183 | 7,058 | |||||
Non-current liabilities | |||||||
Lease liability | 163 | 321 | |||||
Post-employment benefit liabilities | 141 | 145 | |||||
Warrants | 2,518 | - | |||||
Total non - current liabilities | 2,822 | 466 | |||||
Equity | |||||||
Share capital, no par value | - | - | |||||
Share premium | 133,184 | 126,407 | |||||
Receipts on account of warrants | 28,467 | 28,017 | |||||
Capital reserve for share-based payments | 10,088 | 10,164 | |||||
Capital reserve from transactions with related parties | 761 | 761 | |||||
Capital reserve from hedging | 19 | (6 | ) | ||||
Capital reserve from transactions with non- controlling interest | (859 | ) | (859 | ) | |||
Accumulated loss | (137,453 | ) | (117,573 | ) | |||
Equity attributable to owners of the Company | 34,207 | 46,911 | |||||
Non-controlling interests | 90 | 187 | |||||
Total equity | 34,297 | 47,098 | |||||
Total liabilities and equity | 44,302 | 54,622 | |||||
Consolidated Unaudited Statements of Operations | |||||||||||||||
For the year ended | For the three months ended | ||||||||||||||
2023 | 2022 | 2023 | 2022 | ||||||||||||
USD thousands | USD thousands | USD thousands | USD thousands | ||||||||||||
Research and development expenses | 17,034 | 16,320 | 5,242 | 4,820 | |||||||||||
Sales, general and administrative expenses | 5,237 | 6,283 | 1,025 | 1,781 | |||||||||||
Operating loss | 22,271 | 22,603 | 6,267 | 6,601 | |||||||||||
Changes in fair value of warrants | (3,497 | ) | (3,497 | ) | |||||||||||
Finance expenses | 2,195 | 67 | 2,089 | 18 | |||||||||||
Finance income | (992 | ) | (910 | ) | - | (576 | ) | ||||||||
Finance (income) expense, net | (2,294 | ) | (843 | ) | (1,408 | ) | (558 | ) | |||||||
Loss for the period | 19,977 | 21,760 | 4,859 | 6,043 | |||||||||||
Other Comprehensive Loss: | |||||||||||||||
Items that will be transferred to profit or loss: | |||||||||||||||
Loss (profit) from cash flow hedges | (25 | ) | (6 | ) | (21 | ) | 11 | ||||||||
Total comprehensive loss for the period | 19,952 | 21,766 | 4,838 | 6,032 | |||||||||||
Loss attributable to: | |||||||||||||||
Owners of the Company | 19,880 | 21,668 | 4,828 | 6,011 | |||||||||||
Non-controlling interests | 97 | 92 | 31 | 32 | |||||||||||
19,977 | 21,760 | 4,859 | 6,043 | ||||||||||||
Total comprehensive loss attributable to | |||||||||||||||
Owners of the Company | 19,855 | 21,674 | 4,807 | 6,000 | |||||||||||
Non-controlling interests | 97 | 92 | 31 | 32 | |||||||||||
19,952 | 21,766 | 4,838 | 6,032 | ||||||||||||
Loss per share data | |||||||||||||||
Continuing operations | |||||||||||||||
Basic and diluted loss per ADS - USD | 0.90 | 1.20 | 0.19 | 0.33 | |||||||||||
Number of ADSs used in calculation | 22,133,294 | 18,081,087 | 25,789,760 | 18,389,230 | |||||||||||
Consolidated Unaudited Statements of Cash Flow | |||||||||||||||||||||||||||
For the year ended | For the three months ended | ||||||||||||||||||||||||||
2023 | 2022 | 2023 | 2022 | ||||||||||||||||||||||||
USD thousands | USD thousands | USD thousands | USD thousands | ||||||||||||||||||||||||
Cash flows from operating activities: | |||||||||||||||||||||||||||
Loss for the period from continuing operation | (19,977 | ) | (21,760 | ) | (4,859 | ) | (6,043 | ) | |||||||||||||||||||
Adjustments: | |||||||||||||||||||||||||||
Depreciation | 197 | 201 | 48 | 50 | |||||||||||||||||||||||
Finance expense (income), net | (2,294 | ) | (843 | ) | (1,408 | ) | (558 | ) | |||||||||||||||||||
Share-based payments | 1,875 | 2,412 | 181 | 839 | |||||||||||||||||||||||
(20,199 | ) | (19,990 | ) | (6,038 | ) | (5,712 | ) | ||||||||||||||||||||
Changes in assets and liabilities: | |||||||||||||||||||||||||||
Changes in other current assets | 178 | 313 | (41 | ) | 437 | ||||||||||||||||||||||
Changes in accounts payable | 1,334 | 799 | 919 | (735 | ) | ||||||||||||||||||||||
Changes in other payables | (1,076 | ) | 2,132 | 179 | 1,637 | ||||||||||||||||||||||
Changes in post-employment benefit liabilities | (162 | ) | 11 | (1 | ) | 159 | |||||||||||||||||||||
274 | 3,255 | 1,056 | 1,498 | ||||||||||||||||||||||||
Net cash used in operating activities | (19,925 | ) | (16,735 | ) | (4,982 | ) | (4,214 | ) | |||||||||||||||||||
Cash flows from investing activities: | |||||||||||||||||||||||||||
Acquisition of subsidiary, net of cash acquired | (3,549 | ) | - | - | |||||||||||||||||||||||
Proceed from other investment | 875 | - | - | ||||||||||||||||||||||||
Acquisition of intangible asset | - | (202 | ) | - | - | ||||||||||||||||||||||
Decrease (increase) in short term deposits | 15,803 | 19,658 | (6 | ) | |||||||||||||||||||||||
Decrease in long terms deposits | - | 160 | - | 7,999 | |||||||||||||||||||||||
Interest received | 755 | 324 | 80 | - | |||||||||||||||||||||||
Acquisition of fixed assets | (3 | ) | (26 | ) | - | - | |||||||||||||||||||||
Net cash provided by investing activities | 13,881 | 19,914 | 74 | 7,999 | |||||||||||||||||||||||
Cash flows from financing activities: | |||||||||||||||||||||||||||
Proceeds from issuance of ADSs | 1,563 | 1,498 | 4 | 186 | |||||||||||||||||||||||
ADS issuance expenses paid | (229 | ) | (152 | ) | (41 | ) | (38 | ) | |||||||||||||||||||
Proceeds from issuance of ADSs, warrants and prefunded warrants | 5,000 | - | 5,000 | - | |||||||||||||||||||||||
Warrants issuance expenses paid | (661 | ) | - | (661 | ) | ||||||||||||||||||||||
Repayment of lease liability | (168 | ) | (165 | ) | (42 | ) | (41 | ) | |||||||||||||||||||
Interest paid | (56 | ) | (67 | ) | (14 | ) | (18 | ) | |||||||||||||||||||
Net cash provided by financing activities | 5,449 | 1,114 | 4,246 | 89 | |||||||||||||||||||||||
Net increase (decrease) in cash and cash equivalents | (595 | ) | 4,293 | (662 | ) | 3,874 | |||||||||||||||||||||
Cash and cash equivalents at the beginning of the period | 15,030 | 10,890 | 15,104 | 11,074 | |||||||||||||||||||||||
Effect of translation adjustments on cash and equivalents | 54 | (153 | ) | 47 | 82 | ||||||||||||||||||||||
Cash and cash equivalents at end of the period | 14,489 | 15,030 | 14,489 | 15,030 | |||||||||||||||||||||||
Reconciliation of Non-IFRS financial Results | |||||||||||
Reconciliation of Adjusted Operating Loss | |||||||||||
For the year ended | For the three months ended | ||||||||||
2023 | 2022 | 2023 | 2022 | ||||||||
USD thousands | USD thousands | USD thousands | USD thousands | ||||||||
Operating loss for the year | 22,271 | 22,603 | 6,267 | 6,601 | |||||||
Less ESOP expenses | (1,875 | ) | (2,412 | ) | (181 | ) | (839 | ) | |||
20,396 | 20,191 | 6,086 | 5,762 | ||||||||
Reconciliation of Adjusted Net Loss | |||||||||||
For the year ended | For the three months ended | ||||||||||
2023 | 2022 | 2023 | 2022 | ||||||||
USD thousands | USD thousands | USD thousands | USD thousands | ||||||||
Net loss for the year | 19,977 | 21,760 | 4,859 | 6,043 | |||||||
Less ESOP expenses | (1,875 | ) | (2,412 | ) | (181 | ) | (839 | ) | |||
Less finance income from financial instruments | 4,014 | 244 | 3,432 | 244 | |||||||
22,116 | 19,592 | 8,110 | 5,448 | ||||||||
Source:
2024 GlobeNewswire, Inc., source