“We look forward to presenting compelling interim Phase 2 CM24 data for the treatment of pancreatic cancer at ASCO 2024, where we were selected for a Late Breaking Abstract presentation. These data suggest an exciting medical direction, demonstrating potentially reduced risk of disease progression and death in a very difficult to treat indication. Following the announcement of interim results at ASCO on
Q1 2024 and Recent Clinical & Corporate Highlights:
- CM24 Pancreatic Cancer Study Selected for Late Breaking Abstract Poster Presentation at ASCO 2024
- Interim data suggest reduced risk of progression or death in the CM24/nivolumab plus standard of care Nal-IRI/5FU/LV arm of the study supported by higher overall response rate (ORR) and disease control rate (DCR) and decreasing CA19-9 in the experimental arm. Full interim data have been submitted to the ASCO Meeting.
- Interim data to be announced on
June 1 , 2024 in conjunction with the ASCO presentation - Topline data expected Q4 2024
The Phase 2 study is evaluating CM24 in combination with Bristol Myers Squibb’s PD-1 inhibitor nivolumab plus standard of care (SoC) chemotherapy in second line pancreatic ductal adenocarcinoma (PDAC) patients compared to SoC chemotherapy alone. The experimental arms of the study dosed patients with CM24 plus nivolumab and one of two SoC chemotherapies, gemcitabine/nab-paclitaxel or Nal-IRI/5FU/LV, while the control arms dosed with either respective chemotherapy alone. Approximately 60 patients have been enrolled in the randomized study across 18 centers in the
- Phase 2 study of NT219in combination with cetuximab as a 2nd Line treatment for R/M SCCHNis planned to commence in 2024.
- NT219Positive Efficacy Data in Head & Neck Cancer Presented at ESMO-TAT 2024.
- Posters presented at AACR 2024 demonstrated NT219’s efficacy in suppressing cancer stem cells, overcoming resistance to KRASinhibitors andpotential biomarkers for NT219 therapy.
Established Head & Neck Cancer Scientific Advisory Board .
In a presentation at ESMO-TAT 2024, NT219 in combination with cetuximab demonstrated safety and early activity in patients with Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck (R/M SCCHN) with dose-proportional PK values. Of the 7 evaluable R/M SCCHN patients treated at the maximum doses of 50 and 100mg/kg in which anti-tumor activity was observed, the tumor objective response rate (ORR) was 29% and the disease control rate (DCR) was 71%, both highly encouraging results. 100mg/kg was determined to be the recommended Phase 2 dose for NT219 in combination with cetuximab in the treatment of R/M SCCHN.
Key findings were shared in two poster presentations at the
In preparation for its upcoming Phase 2 trial of NT219,
- Proof of Concept Achieved for Tri-Specific Antibody Platform Technology
- Platform has potential to produce a pipeline of promising drug candidates across numerous solid cancer tumors
- Lead asset, IM1240, expected to be ready for Phase 1study by early 2026
Purple Biotech’s tri-specific platform is a T cell engager via the anti-CD3 arm, and an NK cell engager via the anti-NKG2A arm, which also functions as an important immune checkpoint inhibitor of both NK cells and specific subsets of T cells; this tri-specific approach unleashes both innate and adaptive immune systems against the tumor. Preclinical studies demonstrated an anti-tumor response and synergistic effects of the NK cell engager with the conditionally-activated T cell engager. The tri-body platform’s cleavable capping technology confines therapeutic activity to the local tumor micro environment, which increases the anticipated therapeutic window in patients.
Financial Results for the Quarter Ended March 31, 2024
Research and Development Expenses were
Sales, General and Administrative Expenses were
Operating Loss was
Adjusted Operating Loss (as reconciled below) was
Net Loss was
Adjusted Net Loss (as reconciled below) for the three months ended
As of
During 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 erformance. 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:
2024 | 2023 | |||||||
USD thousands | USD thousands | |||||||
Assets | ||||||||
Cash and cash equivalents | 9,985 | 14,489 | ||||||
Short term deposits | 848 | 850 | ||||||
Other investments | 21 | 73 | ||||||
Other current assets | 548 | 376 | ||||||
Total current assets | 11,402 | 15,788 | ||||||
Non-current assets | ||||||||
Right to use assets | 278 | 316 | ||||||
Fixed assets, net | 139 | 154 | ||||||
Intangible assets | 28,044 | 28,044 | ||||||
Total non – current assets | 28,461 | 28,514 | ||||||
Total assets | 39,863 | 44,302 | ||||||
Liabilities | ||||||||
Lease liability – short term | 186 | 188 | ||||||
Accounts payable | 3,477 | 3,532 | ||||||
Other payables | 2,801 | 3,463 | ||||||
Warrants | 2,046 | 2,518 | ||||||
Total current liabilities | 8,510 | 9,701 | ||||||
Non-current liabilities | ||||||||
Lease liability | 121 | 163 | ||||||
Post-employment benefit liabilities | 141 | 141 | ||||||
Total non–current liabilities | 262 | 304 | ||||||
Equity | ||||||||
Share capital, no par value | - | - | ||||||
Share premium | 133,696 | 133,184 | ||||||
Receipts on account of warrants | 28,467 | 28,467 | ||||||
Capital reserve for share-based payments | 10,166 | 10,088 | ||||||
Capital reserve from transactions with related parties | 761 | 761 | ||||||
Capital reserve from hedging | 4 | 19 | ||||||
Capital reserve from transactions with non-controlling interest | (859 | ) | (859 | ) | ||||
Accumulated loss | (141,215 | ) | (137,453 | ) | ||||
Equity attributable to owners of the Company | 31,020 | 34,207 | ||||||
Non-controlling interests | 71 | 90 | ||||||
Total equity | 31,091 | 34,297 | ||||||
Total liabilities and equity | 39,863 | 44,302 | ||||||
Consolidated Unaudited Statement of Operations for the three months ended
2024 | 2023 | |||||||
USD thousands | USD thousands | |||||||
Research and development expenses | 3,423 | 3,498 | ||||||
Sales, general and administrative expenses | 1,043 | 1,624 | ||||||
Operating loss | 4,466 | 5,122 | ||||||
Finance expenses | 17 | 59 | ||||||
Finance income | (702 | ) | (278 | ) | ||||
Finance income, net | (685 | ) | (219 | ) | ||||
Loss for the period | 3,781 | 4,903 | ||||||
Other Comprehensive Loss: | ||||||||
Items that will be transferred to profit or loss: | ||||||||
Loss from cash flow hedges | 15 | 1 | ||||||
Total comprehensive loss for the period | 3,796 | 4,904 | ||||||
Loss attributable to: | ||||||||
Owners of the Company | 3,762 | 4,878 | ||||||
Non-controlling interests | 19 | 25 | ||||||
3,781 | 4,903 | |||||||
Total comprehensive loss attributable to | ||||||||
Owners of the Company | 3,777 | 4,879 | ||||||
Non-controlling interests | 19 | 25 | ||||||
3,796 | 4,904 | |||||||
Loss per share data | ||||||||
Basic and diluted loss per ADS – USD | 0.14 | 0.25 | ||||||
Number of ADSs used in calculating basic and diluted loss per ADS | 27,113,434 | 19,838,608 | ||||||
Reconciliation of Adjusted Operating Loss for the three months ended
2024 | 2023 | |||||||
USD thousands | USD thousands | |||||||
Operating loss for the period | 4,466 | 5,122 | ||||||
Less ESOP expenses | (266 | ) | (752 | ) | ||||
4,200 | 4,370 | |||||||
Reconciliation of Adjusted Net Loss for the three months ended
2024 | 2023 | |||||||
USD thousands | USD thousands | |||||||
Net loss for the period | 3,781 | 4,903 | ||||||
Less ESOP expenses | (266 | ) | (752 | ) | ||||
Less finance income from financial instruments | 607 | - | ||||||
4,122 | 4,151 | |||||||
Consolidated Unaudited Statements of Cash Flow
For the three months ended | ||||||||
2024 | 2023 | |||||||
USD thousands | USD thousands | |||||||
Cash flows from operating activities: | ||||||||
Loss for the period | (3,781 | ) | (4,903 | ) | ||||
Adjustments: | ||||||||
Depreciation | 48 | 46 | ||||||
Finance income, net | (685 | ) | (219 | ) | ||||
Share-based payments | 266 | 752 | ||||||
(4,152 | ) | (4,324 | ) | |||||
Changes in assets and liabilities: | ||||||||
Changes in other investments and other current assets | (213 | ) | (329 | ) | ||||
Changes in accounts payable | (46 | ) | 250 | |||||
Changes in other payables | (671 | ) | (1,500 | ) | ||||
Changes in post-employment benefit liabilities | - | (161 | ) | |||||
(930 | ) | (1,740 | ) | |||||
Net cash used in operating activities | (5,082 | ) | (6,064 | ) | ||||
Cash flows from investing activities: | ||||||||
Acquisition of subsidiary, net of cash acquired | - | (3,549 | ) | |||||
Proceed from other investments | 187 | - | ||||||
Decrease in short term deposits | - | 15,803 | ||||||
Interest received | 125 | 352 | ||||||
Acquisition of fixed assets | - | (3 | ) | |||||
Net cash provided by investing activities | 312 | 12,603 | ||||||
Cash flows from financing activities: | ||||||||
Proceeds from issuance of ADSs | 374 | 395 | ||||||
ADS issuance expenses paid | (50 | ) | (75 | ) | ||||
Repayment of lease liability | (45 | ) | (42 | ) | ||||
Interest paid | (11 | ) | (14 | ) | ||||
Net cash provided by financing activities | 268 | 264 | ||||||
Net increase in cash and cash equivalents | (4,502 | ) | 6,803 | |||||
Cash and cash equivalents at the beginning of the period | 14,489 | 15,030 | ||||||
Effect of translation adjustments on cash and equivalents | (2 | ) | 50 | |||||
Cash and cash equivalents at end of the period | 9,985 | 21,883 |
Source:
2024 GlobeNewswire, Inc., source