On August 5, 2021 Purple Biotech Ltd. ("Purple Biotech", or the "Company") (NASDAQ/TASE: PPBT), a clinical-stage company developing first-in-class, effective and durable therapies by overcoming tumor immune evasion and drug resistance, reported financial results for the six months ended June 30, 2021 (Press release, Purple Biotech, AUG 5, 2021, View Source [SID1234585919]).
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"We achieved significant progress in the advancement of our promising oncology pipeline during the first half of 2021," said Isaac Israel, Chief Executive Officer of Purple Biotech. "For NT219, we are currently treating patients in the third dose cohort of our ongoing Phase 1/2 clinical trial, and presented encouraging initial safety and efficacy results from this study at ASCO (Free ASCO Whitepaper). The initial results from the first dose level cohort demonstrated that NT219 was well-tolerated with minimal serious adverse events, and a partial response, including complete remission at the largest target lesion, was observed in one refractory patient previously treated with four lines of therapies. We expect to report additional data from higher dose levels of this study in the second half of this year. Moreover, for CM24, we are currently recruiting patients into the second dose cohort of our ongoing Phase 1b/2 clinical trial. There were no dose-limiting toxicities or serious clinically relevant adverse events observed in any patient enrolled in the first cohort of the study and we intend to provide additional preliminary safety and efficacy data at an upcoming medical conference."
"Importantly, our robust clinical development programs are supported by a strong balance sheet. With $53.4 million in cash, cash equivalent, short and long-term deposits at the end of June 2021, our cash runway extends into 2024," concluded Mr. Israel.
Recent Corporate Highlights
NT-219:
● Presented new data from the first dose level cohort of the ongoing Phase 1/2 clinical trial of NT219 at the 2021 the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting. Initial results from the first dose level cohort showed that NT219 was well-tolerated with minimal serious adverse events. In addition, a partial response was observed in a patient with refractory gastroesophageal junction cancer, previously treated with four lines of therapies. In this patient, who had been treated for 22 weeks, a complete remission was seen at the largest target lesion and at one non-target lesion, while stable disease was observed at the other non-target lesion.
● Presented additional preclinical data supporting the mechanism of action of NT219 in a poster entitled, "Adaptation of colorectal cancer cells to the brain microenvironment: The role of IRS2," at the American Association of Cancer Research (AACR) (Free AACR Whitepaper) 2021 Annual Meeting.
● Ongoing Phase 1/2 trial currently includes five active sites in the U.S, with others in the U.S. and Israel expected to be activated throughout the year.
CM24:
● Completed first dose level in Phase 1b/2 clinical trial of CM24, a monoclonal antibody blocking CEACAM1, in combination with nivolumab (Opdivo), a PD-1 inhibitor, in patients with advanced cancer, with expansion cohorts in subjects with non-small cell lung cancer and pancreatic cancer.
● The first dose level cohort demonstrated that CM24 in combination with nivolumab was well-tolerated with minimal serious adverse events.
● Currently recruiting patients into the second dose cohort of this study.
● Ongoing Phase 1b/2 trial currently includes three active sites in the U.S. and one in Israel, with others in the U.S., EU and Israel expected to be activated throughout the year.
CONSENSI:
● As previously disclosed, sales of Consensi in the U.S. have been adversely impacted by the ongoing COVID-19 pandemic. In addition, our U.S distribution partner has not fulfilled all its obligations as per the distribution agreement. The Company is currently evaluating its plans in order to maximize the value of Consensi.
Financial Results for the Six Months Ended June 30, 2021
No revenue was recorded for the six months ended June 30, 2021, as compared to $1.0 million for the same period of 2020.
Research and Development Expenses were $7.1 million, an increase of $4.0 million, or 129%, compared to $3.1 million in the same period of 2020. The increase was due to expenses related to the ongoing NT219 and CM24 clinical trials, including the manufacturing of drug for the studies.
Selling, General and Administrative (SG&A) Expenses were $3.2 million, compared to $2.2 million in the same period of 2020, an increase of $1 million. The increase was mainly due to a $0.6 million increase in ESOP costs and an increase in legal, consulting fees and insurance costs.
Operating Loss was $10.3 million, an increase of $6.0 million, or 139%, compared to $4.3 million in the same period of 2020.
On a non-IFRS basis (as reconciled below), adjusted operating loss was $8.9 million, an increase of $5.3 million, compared to $3.6 million in the same period of 2020, mainly due to the increased expenses for clinical studies and manufacturing of drug for these studies.
Net Loss for the first half of 2021 was $10.2 million, or $0.59 per diluted share, compared to a net loss of $27.8 million, or $4.63 per diluted share, in the first half of 2020. The decrease in net loss was due to $23.5 million in expenses related to a change in the fair value of derivatives, offset by an increase of $4.9 million in operating expenses and decrease of $1 million in revenues. Adjusted net loss for the first half was $8.8 million, an increase from $3.5 million in the first half of 2020.
As of June 30, 2021, Purple Biotech had cash and cash equivalents and short- and long-term deposits of $53.4 million, compared to $60.8 million on December 31, 2020. The Company believes that its cash position will provide sufficient resources to support its currently anticipated ongoing needs into 2024.