Purple Biotech Reports Fourth Quarter and Full-Year 2023 Financial Results
Purple Biotech Ltd. announces significant clinical progress for CM24 and NT219, along with the acquisition of a promising immuno-engagers platform. Financial results show a decrease in operating loss and an increase in finance income, with a cash runway into 2025.
Positive
Purple Biotech's lead oncology candidates, CM24 and NT219, made substantial clinical advancements in 2023 for challenging cancer indications.
The acquisition of a conditionally activated T cells and NK cell engagers platform enhances Purple Biotech's cancer treatment approach.
Financial results for 2023 show an increase in research and development expenses, a decrease in general and administrative expenses, and a rise in finance income.
Purple Biotech's cash position at the end of 2023 provides a runway into the first half of 2025.
Purple Biotech sold approximately 1,044,000 ADSs in 2023, generating net proceeds of around $1.5 million.
The financial results of Purple Biotech reveal a nuanced picture of their fiscal health and potential trajectory. The company's research and development expenses have increased slightly, reflecting ongoing investment in their clinical trials for NT219 and CM24. This is a typical pattern for a clinical-stage biopharmaceutical company, where heavy investment in R&D is crucial for future success. The decrease in selling, general and administrative expenses suggests effective cost management, which is imperative for a company that is not yet generating revenue from product sales.
However, the operating loss has decreased marginally, indicating a controlled burn rate. The finance income increase, primarily due to the change in the fair value valuation of warrants, is a non-operational factor that investors should consider separately from the core business activities. The company's cash runway is projected to last into the first half of 2025, which is a positive indicator of financial stability in the short to medium term, giving them a buffer to reach significant milestones that could potentially improve their financial standing or necessitate further funding.
The clinical advancements of Purple Biotech's lead oncology candidates, CM24 and NT219, are of significant interest. The completion of enrollment for the Phase 2 PDAC study ahead of schedule suggests efficiency in trial management and could potentially accelerate the timeline for obtaining results. The interim data expected in the first half of 2024 will be crucial for early indications of efficacy and safety. If positive, it could lead to increased investor confidence and potential partnerships or funding opportunities.
Furthermore, the reported biomarker data for CM24 at AACR offers promising insights into the drug's mechanism of action , which could differentiate it from other treatments and provide a competitive edge if the clinical outcomes are positive. The preclinical data supporting NT219's synergy with checkpoint inhibitors could expand its therapeutic potential and marketability. The acquisition of the conditionally activated immuno-engagers platform represents a strategic move into a novel area of cancer treatment, which could offer long-term value creation if the preclinical promise translates into clinical success.
Purple Biotech's positioning in the oncology market is strengthened by their focus on first-in-class therapies and the tumor microenvironment . The oncology market is highly competitive but also offers substantial opportunities for innovative treatments that can demonstrate improved outcomes in difficult-to-treat cancers such as pancreatic and head and neck cancer. The company's strategy to target second line treatments fills a specific niche where there is often a high unmet medical need, potentially allowing for rapid adoption if the therapies prove effective.
The industry's increasing attention to multi-specifics suggests that Purple Biotech's investment in a differentiated approach to cancer treatment may align with market trends. The anticipated data readouts in 2024 will likely be significant market events that could influence the company's stock performance. Investors and analysts will be closely monitoring these developments to assess the company's potential for future revenue generation and its impact on the broader oncology treatment landscape.
03/05/2024 - 07:55 AM
REHOVOT, Israel, March 05, 2024 (GLOBE NEWSWIRE) -- Purple Biotech Ltd. ("Purple Biotech" or "the Company") (NASDAQ/TASE: PPBT), a clinical-stage company developing first-in-class therapies that harness the power of the tumor microenvironment to overcome tumor immune evasion and drug resistance, today announced financial results for the fourth quarter and full year ended December 31, 2023.
“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 Gil Efron, Chief Executive Officer of Purple Biotech.
2023 and Recent Clinical & Corporate Highlights:
CM24 as 2 nd 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 February 2023 and completed enrollment of approximately 60 patients ahead of schedule in December of 2023 through 18 centers in the U.S., Spain and Israel. The Phase 2 study (NCT04731467) is evaluating CM24 in combination with Bristol Myers Squibb’s nivolumab plus chemotherapy in PDAC patients as a second line treatment as compared to standard of care chemotherapy alone.
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 American Association for Cancer Research (AACR) Special Conference on pancreatic cancer, Purple Biotech presented new potential PDAC biomarker data for CM24. The data showed potential association of a high expression of CEACAM1 on tumor infiltrating lymphocytes, CM24's target, with treatment outcomes and decrease in Neutrophil Extracellular Traps (NETs) marker following treatment with CM24, in PDAC patients. This demonstrated the potential of CM24's novel mechanism of action (MOA) in treating pancreatic cancer.
NT219 as 2 nd 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 In a Phase 1 dose escalation study (NCT04474470) of NT219, a first-in-class small molecule dual inhibitor of IRS 1/2 and STAT3, Purple Biotech determined 100mg/kg as the recommended Phase 2 dose for NT219 in combination with Erbitux® (cetuximab) in the treatment of R/M SCCHN. Detailed results from the study were presented at the European Society of Medical Oncology Targeted Anticancer Therapies (ESMO TAT) Congress 2024 in Paris. Safety profile was well tolerated and manageable. Of the 7 evaluable R/M SCCHN patients treated at the highest doses of 50 and 100mg/kg, the tumor objective response rate (ORR) was 29% and the disease control rate (DCR) was 71% , both highly encouraging results. Median follow-up across all dose levels was 9.4 months as of the cutoff date (95% CI: 3.4-10.0, 8 out of 15 patients remaining in follow up).
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 Head and Neck Cancer Scientific Advisory Board, which provided us their guidance on clinical studies for NT219 in combination with cetuximab as a second line treatment and potentially in combination with a PD1 inhibitor as a first line treatment.
At the AACR Annual Meeting 2023 in Orlando, Florida, results presented from a preclinical study demonstrated the potential of NT219 to work synergistically with either anti-PD1 or anti-CTLA4 drugs to reprogram the immune profile in the tumor microenvironment and convert resistant tumors to responders. The study was led by researchers at The University of Texas MD Anderson Cancer Center.
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 February 2023, Purple Biotech acquired a platform of conditionally activated T cell and NK cell engagers that selectively activate immune response within the tumor microenvironment. The platform’s lead tribody in development, IM1240, which is expected to be ready for an Investigational New Drug (IND) filing with the U.S. Food and Drug Administration in approximately two years, targets the antigen 5T4 to induce a strong immune system response against cancer cells. 5T4 is highly expressed on certain tumors and correlates with poor prognosis.
Financial Results for the Year Ended December 31, 2023
Research and Development Expenses were $17 million , an increase of $0.7 million , or 4.3% , compared to $16.3 million in 2022. The increase was mainly due to expenses related to the ongoing NT219 and CM24 clinical trials, including chemistry, manufacturing and controls (CMC) expenses.
Selling, General and Administrative Expenses were $5.2 million , compared to $6.3 million in 2022, a decrease of $1.1 million mainly due to a decrease in salary, insurance and share based payment expenses.
Operating Loss was $22.3 million , a decrease of $0.3 million , or 1.3% , compared to $22.6 million 2022. The decrease was mainly due to the decrease in selling, general and administrative expenses offset by the increase in research and development expenses.
Finance income for 2023 was $2.3 million , an increase of $1.5 million , or 188% , compared to $0.8 million in 2022. The increase was mainly due to the change in the fair value valuation of warrants.
On a non-IFRS basis (as reconciled below), adjusted operating loss was $20.4 million , an increase of $0.2 million , compared to $20.2 million in 2022, mainly due to the increased operating loss of $0.3 million offset by decrease in share based payment expenses of $0.5 million .
Net Loss for 2023 was $20 million , or $0.90 per basic and diluted share, compared to a net loss of $21.8 million , or $1.20 per basic and diluted share, in 2022. The decrease in net loss was mainly due to the increase in finance income and decrease in selling, general and administrative expenses. Adjusted net loss for 2023 was $22.1 million , an increase from $19.6 million in the full year of 2022.
As of December 31, 2023, Purple Biotech had cash and cash equivalents and short-term deposits of $15.3 million , compared to $31.7 million on December 31, 2022. This cash position provides a cash runway into the first half of 2025.
During the year ended December 31, 2023, the Company sold, under the Open Market Sale Agreement with Jefferies LLC, approximately 1,044,000 ADSs, at an average price of $1.63 per ADS. Net proceeds to the Company were approximately $1.5 million , net of issuance expenses.
Financial Results for the Three Months Ended December 31, 2023
Research and Development Expenses were $5.2 million , an increase of $0.4 million , or 8.3% , compared to $4.8 million in the same period of 2022. The increase was mainly due to expenses related to the CM24 and NT219 clinical trials.
Selling, General and Administrative Expenses were $1 million , compared to $1.8 million in the same period of 2022, a decrease of $0.8 million , mainly due to salary and share based payment expenses.
Operating Loss was $6.3 million , a decrease of $0.3 million , or 4.5% , compared to $6.6 million in the same period of 2022.
On a non-IFRS basis (as reconciled below), adjusted operating loss was $6.0 million , an increase of $0.2 million , compared to $5.8 million in the same period of 2022, mainly due to an increase in research and development expenses.
Finance income for the three months ended December 31, 2023 was $1.4 million , an increase of $0.8 million , or 133% , compared to $0.6 million in the same period of 2022. The increase was mainly due to the change in the fair value evaluation of warrants.
Net Loss for the three months ended December 31, 2023 was $4.9 million , or $0.19 per basic and diluted share, compared to a net loss of $6.0 million , or $0.33 per basic and diluted, in the three months ended December 31, 2022. The decrease in net loss was mainly due to an increase in financial income from financial instruments. Adjusted net loss for the three months ended December 31, 2023 was $8.1 million , an increase from $5.4 million in the same period of 2022.
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 Purple Biotech Purple Biotech Ltd. (NASDAQ/TASE: PPBT) is a clinical-stage company developing first-in-class therapies that seek to overcome tumor immune evasion and drug resistance. The Company's oncology pipeline includes NT219, CM24 and IM1240. NT219 is a dual inhibitor, novel small molecule that simultaneously targets IRS1/2 and STAT3. A Phase 1 dose escalation study is being concluded and a phase 2 study of NT219 at its recommended Phase 2 level in combination with cetuximab in patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck cancer (SCCHN) is planned. CM24 is a humanized monoclonal antibody that blocks CEACAM1, an immune checkpoint protein that supports tumor immune evasion and survival through multiple pathways. The Company is advancing CM24 as a combination therapy with anti-PD-1 checkpoint inhibitors in a Phase 2 study for the treatment of pancreatic ductal adenocarcinoma (PDAC). The Company has entered into a clinical collaboration agreement with Bristol Myers Squibb for the Phase 2 clinical trials to evaluate the combination of CM24 with the PD-1 inhibitor nivolumab in addition to chemotherapy. The Company is advancing a preclinical platform of conditionally-activated tri-specific antibodies that engage both T cells and NK cells to induce a strong, localized immune response within the tumor microenvironment. The cleavable capping technology confines the compound's therapeutic activity to the local tumor microenvironment, and thereby potentially increases the anticipated therapeutic window in patients. The third arm of the antibody specifically targets the Tumor Associated Antigen (TAA). The technology presents a novel mechanism of action by unleashing both innate and adaptive immune systems to mount an optimal anti-tumor immune response. IM1240 is the platform’s lead tribody in development that targets 5T4 expressed in a variety of solid tumors and is correlated with advanced disease, increased invasiveness and poor clinical outcomes. The Company's corporate headquarters are located in Rehovot, Israel. For more information, please visit https://purple-biotech.com/ .
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 U.S. Food and Drug Administration or any other applicable regulator of pharmaceutical products; the regulatory environment and changes in the health policies and regimes in the countries in which we operate; the uncertainty surrounding the actual market reception to our pharmaceutical products once cleared for marketing in a particular market; the introduction of competing products; patents obtained by competitors; dependence on the effectiveness of our patents and other protections for innovative products; our ability to obtain, maintain and defend issued patents; the commencement of any patent interference or infringement action against our patents, and our ability to prevail, obtain a favorable decision or recover damages in any such action; and the exposure to litigation, including patent litigation, and/or regulatory actions; the impact of the economic, public health, political and security situation in Israel, the U.S. and other countries in which we may operate or obtain approvals for our products or our business, and other factors that are discussed in our Annual Report on Form 20-F for the year ended December 31, 2023 and in our other filings with the U.S. Securities and Exchange Commission ("SEC"), including our cautionary discussion of risks and uncertainties under "Risk Factors" in our Registration Statements and Annual Reports. These are factors that we believe could cause our actual results to differ materially from expected results. Other factors besides those we have listed could also adversely affect us. Any forward-looking statement in this press release speaks only as of the date which it is made. We disclaim any intention or obligation to publicly update or revise any forward-looking statement or other information contained herein, whether as a result of new information, future events or otherwise, except as required by applicable law. You are advised, however, to consult any additional disclosures we make in our reports to the SEC, which are available on the SEC's website, https://www.sec.gov.
CONTACTS:
Company Contact: Lior Fhima Chief Financial OfficerIR@purple-biotech.com
Consolidated Statements of Financial Position as of December 31, 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 December 31, December 31, 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
Purple Biotech Ltd. Consolidated Unaudited Statements of Cash Flow For the year ended For the three months ended December 31, December 31, 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
Purple Biotech Ltd. Reconciliation of Non-IFRS financial Results Reconciliation of Adjusted Operating Loss For the year ended For the three months ended December 31, December 31, 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 December 31, December 31, 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
What are Purple Biotech's lead oncology candidates?
Purple Biotech's lead oncology candidates are CM24 and NT219.
What is the primary endpoint of the Phase 2 study for CM24 in PDAC patients?
The primary endpoint of the Phase 2 study for CM24 in PDAC patients is overall survival (OS).
What is the recommended Phase 2 dose for NT219 in R/M SCCHN treatment?
The recommended Phase 2 dose for NT219 in R/M SCCHN treatment is 100mg/kg.
What is Purple Biotech's lead tribody target in the immuno-engagers platform acquisition?
Purple Biotech's lead tribody target in the immuno-engagers platform acquisition is 5T4.
What was Purple Biotech's operating loss for 2023?
Purple Biotech's operating loss for 2023 was $22.3 million.
What was Purple Biotech's cash position at the end of 2023?
Purple Biotech's cash position at the end of 2023 was $15.3 million.
How many ADSs did Purple Biotech sell in 2023?
Purple Biotech sold approximately 1,044,000 ADSs in 2023.