On November 8, 2022 Purple Biotech Ltd. ("Purple Biotech", or the "Company") (NASDAQ/TASE: PPBT), a clinical-stage company developing first-in-class, effective and durable therapies by harnessing the power of the tumor microenvironment to overcome tumor immune evasion and drug resistance, reported financial results for the third quarter ended September 30, 2022 (Press release, Purple Biotech, NOV 8, 2022, View Source [SID1234623433]).
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"As we prepare for 2023, we are advancing the clinical development of our two lead investigational assets, CM24 and NT219, and exploring additional options to build the Company’s pipeline of first-in-class assets for treatment of cancers with high unmet clinical need," said Gil Efron, Chief Executive Officer of Purple Biotech. "Purple is well positioned with a cash runway to meet clinical milestones through 2024. In addition to our financial results, we are proud to provide our corporate update focused on enhancing our clinical program."
Corporate Updates
CM24 Study Design Update
The Company has amended the Phase 2 clinical trial evaluating the use of its monoclonal antibody CM24, a new immune checkpoint inhibitor, in combination with the PD-1 inhibitor Opdivo (nivolumab) plus chemotherapy for patients with 2L metastatic pancreatic cancer (PDAC). The clinical trial design has been amended to randomize the study comparing CM24+nivolumab+standard-of-care (SoC) chemotherapy against SoC chemotherapy alone. The study is ongoing, and patients are already being treated in a run-in portion of the study, which includes up to 18 patients followed by approximately 60 patients in the randomized part of the study. Interim analysis expected in the second half of 2023 and a topline report on the overall study at the end of 2024.
NT219 Study Progress
In the monotherapy arm of the Phase 1/2 clinical trial for NT219, participants are being treated at the 50mg/kg dose level, which is the last dose to be evaluated for monotherapy. In the combination arm of NT219+cetuximab of the same study, participants are receiving a 24 mg/kg dose of NT219, the penultimate dose being evaluated in this arm. As this trial progresses, we expect to report the recommended Phase 2 dose (RP2D) for monotherapy in the first quarter of 2023, and RP2D for the combination with cetuximab in the second quarter of 2023.
CFO Appointment
The Purple Biotech team welcomed Lior Fhima, CPA, MBA, as Chief Financial Officer of the Company in November. Mr. Fhima brings deep expertise in financial management in the pharmaceutical industry and strong managerial capabilities. We look forward to his contributions in growing Purple Biotech as we advance our first-in-class oncology assets.
"We anticipate that 2023 will be an important year for Purple Biotech, as we plan to report data from our ongoing clinical programs for our two investigational oncology assets. Additionally, we will continue to pursue potential collaborations and commercial opportunities for CM24 and NT219, as well as acquisitions or collaborations related to other first-in-class oncology therapeutics that may be able to address large unmet clinical needs for patients living with devastating cancers," added Mr. Efron.
Financial Results for the three Months Ended September 30, 2022
Research and Development Expenses were $3.5 million, an increase of $1.9 million, or 118.8%, compared to $1.6 million in the same period of 2021. The increase was mainly due to an increase of $0.5 million in CMC expenses in support of our clinical studies, an increase of $0.8 million for our clinical trials expenses and $0.3 million in payroll and share based payment expenses in support our growing development activities.
Selling, General and Administrative Expenses were $1.6 million, an increase of $0.2 million, or 14.3%, compared to $1.4 million in the same period of 2021. The increase was mainly due to increase of $0.2 million in payroll expenses.
Operating Loss was $5.1 million, an increase of $2.1 million, or 66.67%, compared to $3.0 million in the same period of 2021. The increase was mainly due to the increase in research and development expenses.
On a non-IFRS basis (as reconciled below), adjusted operating loss was $4.4 million, an increase of $1.7 million, compared to $2.7 million in the same period of 2021.
Net Loss for the three months ended September 30, 2022 was $4.8 million, or $0.27 per basic and diluted ADS, compared to a net loss of $3.1 million, or $0.17 per basic and diluted ADS, in the three months ended September 30, 2021. Adjusted net loss for the three months ended September 30, 2022 was $4.1 million, an increase from $2.6 million in the three months ended September 30, 2021.
Financial Results for the Nine Months Ended September 30, 2022
Research and Development Expenses were $11.5 million, an increase of $2.9 million, or 33.7%, compared to $8.6 million in the same period of 2021. The increase was mainly due to an increase of $1.06 million in CMC expenses in support of our clinical studies, an increase of $0.9 million for our clinical trials expenses and $0.7 million in payroll and share based payment expenses in support our growing development activities.
Sales, General and Administrative Expenses were $4.5 million, compared to $4.6 million in the same period of 2021, a decrease of $0.1 million.
Operating Loss from continuing operations was $16 million, an increase of $2.8 million, or 21.2%, compared to $13.2 million in the same period of 2021. The increase was mainly due to the increase in research and development expenses.
On a non-IFRS basis (as reconciled below), adjusted operating loss was $14.4 million, an increase of $3.0 million, compared to $11.4 million in the same period of 2021, mainly due to an increase in R&D expenses.
Net Loss for the first nine months ended September 30, 2022 was $15.7 million, or $0.87 per basic and diluted ADS, compared to a net loss of $13 million, or $0.75 per basic and diluted ADS, in the same period of 2021. The increase in net loss was mainly due to an increase of $2.8 million in operating expenses. Adjusted net loss for nine months ended September 30, 2022 was $14.1 million, an increase from $11.3 million in the nine months ended September 30, 2021.
As of September 30, 2022, the Company had a total amount of $35.7 million in cash, cash equivalent and short and long term deposits.
During the nine months ended September 30, 2022, the Company sold, under the Open Market Sale Agreementsm with Jefferies LLC, approximately 453 thousand ADSs, at an average price of $2.92 per ADS. Net proceeds to the Company, were approximately $1.3 million, net of issuance expenses.