On February 8, 2023 Purple Biotech Ltd. ("Purple Biotech" or "the Company") (NASDAQ/TASE: PPBT), a clinical-stage company developing first-in-class, effective and durable therapies that harness the power of the tumor microenvironment to overcome tumor immune evasion and drug resistance, reported financial results for the year and the three months ended December 31, 2022 (Press release, Purple Biotech, FEB 8, 2023, View Source [SID1234626962]).
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"We are reporting our 2022 financial results which are in line with our plans," said Gil Efron, Chief Executive Officer of Purple Biotech. "Our end-of-year balance sheet is strong and enables us to execute our strategic plan. We started 2023 by acquiring an innovative platform of tri-specific antibodies and we are looking forward to data readouts from both of our ongoing clinical programs. I believe that our diverse promising pipeline is a good foundation for building a strong and sustainable oncology company.
"During 2022 we enhanced the CM24 trial, reprioritizing its study arms and expanding the design to randomize the study – a good example of the thoughtful, flexible approach we take to drug development. For NT219 we advanced the dose escalation Phase 1 study, both as monotherapy and in combination with cetuximab, and have reached the 50mg/kg dose level in both arms. We anticipate reporting clinical data for both CM24 and NT219 during this coming year. We just completed the acquisition of Immunorizon, thus securing a valuable portfolio of multi-specific antibodies that are highly complementary to our existing clinical compounds targeting the tumor microenvironment."
Business Development, Post-Fiscal 2022
● Immunorizon Acquisition Expands Company Pipeline
After the close of the 2022 fiscal year, Purple Biotech expanded its product pipeline through the acquisition of private company Immunorizon Ltd.. This acquisition, signed on February 2, 2023, brings a portfolio of potential multi-specific T and NK cell engager oncology therapies that selectively activate the immune response within the tumor microenvironment. The lead asset targets the antigen 5T4, activating both T and NK cells to mount a powerful immune system response against cancer cells; importantly, the compound includes a cleavable capping technology that has the potential to widen the therapeutic index. The acquisition provides Purple Biotech with a technology platform for tri-specific antibody compounds and offers the potential to further expand to additional targets. The Company anticipates bringing the first of these assets to IND filing in approximately two years.
● Collaboration with Mor Research Applications
Also after the close of fiscal 2022, Purple Biotech announced on January 3, 2023, a research collaboration with Mor Research Applications, the technology transfer subsidiary of Clalit Healthcare Services. The agreement gives Purple first access to pre-clinical oncology product candidates owned by Mor, including the option to fund early development, in-license selected drug assets and pursue their development and commercialization.
Corporate Updates for 2022
Clinical Studies
● CM24 Study Design Update (PDAC)
The Company has amended the Phase 2 clinical trial evaluating the combination of its monoclonal antibody CM24, a potential new first-in-class mAb that blocks the immune checkpoint CEACAM1 from supporting tumor immune evasion and survival, with the PD-1 inhibitor (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. The study is ongoing, with patients 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. An interim analysis is expected in the second half of 2023 and a topline report on the overall study at the end of 2024.
● CM24 Presentation at AACR (Free AACR Whitepaper) Special Conference
At the American Association of Cancer Research (AACR) (Free AACR Whitepaper) Special Conference: Cancer Metastasis in November, Purple Biotech presented data that provide a rationale for an innovative mechanism of action for CM24. "CM24, a Novel Anti-CEACAM1 mAb, Suppresses Neutrophil Extracellular Trap (NET)-Induced Migration and Metastasis of Cancer Cells" focused on the compound’s activity against neutrophil extracellular traps.
● NT219 Study Progress (SCCHN)
In the monotherapy arm of the Phase 1/2 clinical trial for NT219, participants are being treated at the 50 mg/kg dose level, which is the last dose to be evaluated for monotherapy treatment. In the combination arm of NT219 + cetuximab, we are now recruiting for the 50 mg/kg dose of NT219. As this trial progresses, Purple Biotech expects to reach the recommended Phase 2 dose (RP2D) this year and enter into the Phase 2 of this study thereafter.
Management Changes
● In July, Gil Efron transitioned from serving as President and Chief Financial Officer to the Chief Executive Officer position when Isaac Israel stepped down as CEO, while retaining his membership on the Board of Directors and as an advisor to the Company. The Company also welcomed Lior Fhima as Chief Financial Officer in November.
Financial Results for the Year Ended December 31, 2022
Research and Development Expenses were $16.3 million, an increase of $4.5 million, or 38.1%, compared to $11.8 million in the same period of 2021. The increase was mainly due to expenses related to the ongoing NT219 and CM24 clinical trials, including CMC expenses.
Selling, General and Administrative Expenses were $6.3 million, compared to $6.1 million in the same period of 2021, an increase of $0.2 million.
Operating Loss was $22.6 million, an increase of $4.7 million, or 26.3%, compared to $17.9 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 $20.2 million, an increase of $4.3 million, compared to $15.9 million in the same period of 2021, mainly due to the increased expenses for clinical studies and manufacturing of drugs for these studies.
Net Loss for 2022 was $21.8 million, or $1.20 per basic and diluted share, compared to a net loss of $18.5 million, or $1.01 per basic and diluted share, in 2021. The increase in net loss was mainly due to $4.5 million in operating expenses, offset by a decrease of $0.6 million in loss from discontinued operation and an increase in finance income of $0.5 million. Adjusted net loss for the year was $19.6 million, an increase from $15.7 million in the full year of 2021.
As of December 31, 2022, Purple Biotech had cash and cash equivalents, short- and long-term deposits of $31.7 million, compared to $47.4 million on December 31, 2021. This cash position provides a cash runway into the second half of 2024.
During the year ended December 31, 2022, the Company sold, under the Open Market Sale Agreement with Jefferies LLC, approximately 543 thousand ADSs, at an average price of $2.65 per ADS. Net proceeds to the Company were approximately $1.3 million, net of issuance expenses.
Financial Results for the three Months Ended December 31, 2022
Research and Development Expenses were $4.8 million, an increase of $1.6 million, or 50%, compared to $3.2 million in the same period of 2021. The increase was mainly due to expenses related to the CM24 and NT219 clinical trials and CMC expenses.
Selling, General and Administrative Expenses were $1.8 million, compared to $1.5 million in the same period of 2021, an increase of $0.3 million.
Operating Loss was $6.6 million, an increase of $1.9 million, or 40.4%, compared to $4.7 million in the same period of 2021.
On a non-IFRS basis (as reconciled below), adjusted operating loss was $5.8 million, an increase of $1.4 million, compared to $4.4 million in the same period of 2021, mainly to increase in R&D expenses offset by other income.
Net Loss for the three months ended December 31, 2022 was $6.0 million, or $0.33 per basic and diluted share, compared to a net loss of $5.1 million, or $0.29 per basic and diluted, in the three months ended December 31, 2021. The increase in net loss was mainly due to an increase in R&D expenses offset by other income and increase in financial income. Adjusted net loss for the three months ended December 31, 2022 was $5.4 million, an increase from $4.4 million in the same period of 2021.