On May 21, 2024 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, reported financial results for the three months ended March 31, 2024 (Press release, Purple Biotech, MAY 21, 2024, View Source [SID1234643496]).
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"We look forward to presenting compelling interim Phase 2 CM24 data for the treatment of pancreatic cancer at ASCO (Free ASCO Whitepaper) 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 (Free ASCO Whitepaper) on June 1, 2024, we expect to present topline data before the end of year; these clinical milestones will potentially mark significant catalysts for the value of our development pipeline," stated Gil Efron, Chief Executive Officer of Purple Biotech. "We also continue to make solid progress on NT219, which is headed into a Phase 2 trial in head and neck cancer, as well as on our tri-specific antibody platform following a Pre-IND meeting with the FDA that provided a clear path forward for our development plan through Phase 1."
Q1 2024 and Recent Clinical & Corporate Highlights:
● CM24 Pancreatic Cancer Study Selected for Late Breaking Abstract Poster Presentation at ASCO (Free ASCO Whitepaper) 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 (Free ASCO Whitepaper) Meeting.
● Interim data to be announced on June 1, 2024 in conjunction with the ASCO (Free ASCO Whitepaper) presentation
● Topline data expected Q4 2024
The American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) selected Purple Biotech’s poster titled "Interim results of the Randomized Phase 2 Cohort of Study FW-2020-01 Assessing the Efficacy, Safety and Pharmacodynamics of CM24 in combination with Nivolumab and Chemotherapy in Advanced/metastatic Pancreatic Cancer" for a Late Breaking presentation at ASCO (Free ASCO Whitepaper)’s 2024 Annual Meeting.
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 U.S., Spain and Israel. Data from the gemcitabine/nab-paclitaxel arm is not yet mature for analysis.
● Phase 2 study of NT219 in combination with cetuximab as a 2nd Line treatment for R/M SCCHN is planned to commence in 2024.
● NT219 Positive Efficacy Data in Head & Neck Cancer Presented at ESMO (Free ESMO Whitepaper)-TAT 2024.
● Posters presented at AACR (Free AACR Whitepaper) 2024 demonstrated NT219’s efficacy in suppressing cancer stem cells, overcoming resistance to KRAS inhibitors and potential biomarkers for NT219 therapy.
● Established Head & Neck Cancer Scientific Advisory Board.
In a presentation at ESMO (Free ESMO Whitepaper)-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 American Association for Cancer Research (AACR) (Free AACR Whitepaper) 2024 annual meeting in San Diego, California. NT219 was found to significantly suppress cancer stem cells, suggesting a novel therapy and new mechanism to combat cancer recurrence and overcoming resistance to KRAS(G12C) and KRAS(G12D) inhibitors in NSCLC and PDAC cells, respectively. NT219 reverses acquired resistance to KRAS inhibitors by addressing both cellular escape pathways and cancer stem cell mechanisms. Potential biomarkers for NT219 therapy were presented in an additional poster at AACR (Free AACR Whitepaper) 2024, and on-target effects of the therapy were demonstrated in patients’ tumors. Analysis of patients’ biopsies pre-treatment suggests activated IGF1R and STAT3 as potential biomarkers for this therapy.
In preparation for its upcoming Phase 2 trial of NT219, Purple Biotech convened a Scientific Advisory Board (SAB) specifically focused on the R/M SCCHN indication. The SAB is comprised of head and neck cancer key opinion leaders including oncologists, researchers, and investigators. The SAB has provided valuable guidance on clinical studies for NT219 in combination with cetuximab as a second/third line treatment and potentially in combination with a PD1 inhibitor as a first line treatment.
● Proof of Concept Achieved for Tri-Specific Antibody Platform Technology
o Platform has potential to produce a pipeline of promising drug candidates across numerous solid cancer tumors
o Lead asset, IM1240, expected to be ready for Phase 1 study 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 $3.4 million for the three months ended March 31, 2024, a decrease of $0.1 million, or 2.8%, compared to $3.5 million in the same period of 2023.
Sales, General and Administrative Expenses were $1 million for the three months ended March 31, 2024, compared to $1.6 million in the same period of 2023, a decrease of $0.6 million.
Operating Loss was $4.5 million for the three months ended March 31, 2024, a decrease of $0.6 million, or 11.8%, compared to $5.1 million in the same period of 2023, mainly due to the decrease in the sales, general, and administrative expenses.
Adjusted Operating Loss (as reconciled below) was $4.2 million for the three months ended March 31, 2024, a decrease of $0.2 million, compared to $4.4 million in the same period of 2023.
Net Loss was $3.8 million, or $0.14 per basic and diluted ADS for the three months ended March 31, 2024, compared to a net loss of $4.9 million, or $0.25 per basic and diluted ADS, in the same period of 2023. The decrease in net loss was mainly due to a decrease of $0.6 million in operating expenses and an increase of $0.5 million in finance income, net.
Adjusted Net Loss (as reconciled below) for the three months ended March 31, 2024, was $4.1 million, a decrease from $4.2 million in the first three months ended March 31, 2023.
As of March 31, 2024, Purple Biotech had cash and cash equivalents and short-term deposits of $10.8 million. This cash position provides a cash runway into the first quarter of 2025.
During the three months ended March 31, 2024, the Company sold, under the Open Market Sale AgreementSM with Jefferies LLC, approximately 504,000 ADSs, at an average price of $0.742 per ADS. Net proceeds to the Company were approximately $358,000, net of issuance expenses.
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.