Full Press Release Details
Purple Biotech Reports First Quarter 2024 Financial
CM24 Phase 2 Pancreatic Cancer Interim Data
Selected for Late Breaking Abstract Poster Presentation at ASCO 2024 - Interim results to be Announced June 1, 2024
REHOVOT, Israel, May 21, 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 three months ended March 31, 2024.
"We look forward to presenting
compelling interim Phase 2 CM24 data for the treatment of pancreatic cancer at ASCO 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 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:
The American Society of Clinical
Oncology (ASCO) 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'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.
In a presentation at ESMO-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.
findings were shared in two poster presentations at the American Association for Cancer Research (AACR) 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 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
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.
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
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
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.
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 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. Additionally, the Company is advancing a preclinical platform of
a conditionally-activated tri-specific antibody that engages 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 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-tumoral immune response. IM1240 is the first tri-specific antibody in development that targets 5T4, which is 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