Full Press Release Details
Purple Biotech Reports Third Quarter 2023 Financial
Initial Activity in Head and Neck
Cancer Demonstrated in NT219 Phase 1/2 Dose Escalation Study
Patients' Enrollment in the
Phase 2 Randomized CM24 Pancreatic Cancer Trial Ahead of Timelines
Cash Runway Extended to 2H 2025 through
REHOVOT, Israel, Nov. 21, 2023 (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 third quarter and nine months ended September 30, 2023.
"We are pleased to report that we expect to
complete patient enrollment in our Phase 2 randomized CM24 pancreatic cancer study soon, ahead of our previous plan and that might result
in earlier than anticipated analysis of interim and top line overall survival (OS) data during 2024. The interim data look will occur
in 2024 when sufficient progression free survival (PFS) and OS events are registered and enable a meaningful data interpretation for a
larger number of patients. Recently reported biomarker data demonstrates CM24's mechanism of action for this important indication
in dire need of a more effective drug that prolongs survival," stated Purple Biotech CEO, Gil Efron.
"Our Phase 1/2 dose escalation study of NT219
in head and neck cancer demonstrated initial activity at the dose level of 50 mg/kg. We continue dose optimization at a higher dose level
and expect to report additional data during the first half of 2024 in parallel to preparing to enter a Phase 2 study."
"With a cash runway that extends more than
two years, through the second half of 2025, Purple Biotech is very well positioned to execute on multiple value-driving milestones. Moreover,
we expect 2024 to be a year with major clinical data catalysts."
Q3 2023 and Recent Corporate
in the Phase 2 study of CM24 was accelerated and the Company's plan to enroll approximately 60 patients is expected to be completed
soon, ahead of schedule. Since OS and PFS are event-based endpoints, a meaningful estimate of the endpoint can be achieved once sufficient
events occur in the study arms. We expected this to happen in 2024 when enough PFS and OS events are registered and enable meaningful
data interpretation for a larger number of patients. The acceleration allows the Company to reduce the total cost of the trial and to
report, possibly earlier than expected, an interim OS analysis, the study's primary endpoint, together with the analysis of PFS
during 1H 2024. The randomized Phase 2 study (NCT04731467), in clinical collaboration with Bristol Myers Squibb (BMS), is evaluating CM24
in combination with BMS's nivolumab plus chemotherapy in PDAC patients as a second line treatment as compared to chemotherapy alone.
data for CM24 were presented at the American Association for Cancer Research (AACR) Special Conference: Pancreatic Cancer in a scientific
poster titled "Phase 1 Study of CM24 in Combination with Nivolumab in Patients with Advanced Pancreatic Cancer - Survival, Exploratory
Biomarkers and Effect on Neutrophil Extracellular Traps (NETs)". The study showed a high expression of CEACAM1, CM24's target,
on neutrophils and Neutrophil Extracellular Traps (NETs), and that there are enhanced levels of serum NETs in PDAC patients. This study
demonstrated for the first time that CM24 treatment significantly reduced the level of NET marker in patients' serum, suggesting CM24's
novel mechanism of action (MOA) in treating pancreatic cancer.
activity was demonstrated at the 50mg/kg dose level of NT219 at 50mg/kg in combination with cetuximab in the Phase 1 dose escalation study.
A dose-dependent increase in drug exposure of NT219 was reported and target engagement was observed in tumor samples, with 2 of the 4
evaluable recurrent and metastatic squamous cell carcinoma of the head and neck patients dosed at 50mg/kg demonstrated confirmed partial
granted in China for NT219's pharmaceutical composition. The new patent protects the method which prevents the conversion of NT219
from its active form to a less active form and supports maintenance of the active form during manufacturing, storage, and handling until
administered to the patient.
Financial Results for the three Months Ended
Research and Development Expenses were
$4.6 million, an increase of $1.1 million, or 31.43%, compared to $3.5 million in the same period of 2022. The increase was mainly due
to clinical trials expenses in our CM24 study.
Selling, General and Administrative Expenses
were $1.2 million, a decrease of $0.4 million, or 25%, compared to $1.6 million in the same period of 2022. The decrease was mainly
due to a decrease in share based payment expenses.
Operating Loss was $5.7 million, an increase
of $0.7 million, or 14%, compared to $5.0 million in the same period of 2022. 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 $5.3 million, an increase of $0.9 million, compared to $4.4 million in the same period of 2022.
Net Loss for the three months ended
September 30, 2023 was $5 million, or $0.23 per basic and diluted ADS, compared to a net loss of $4.8 million, or $0.27 per basic and
diluted ADS, in the three months ended September 30, 2022. Adjusted net loss for the three months ended September 30, 2023 was
$4.6 million, an increase from $4.1 million in the three months ended September 30, 2022.
Financial Results for the Nine Months Ended
Research and Development Expenses were
$11.8 million, an increase of $0.3 million, or 2.6%, compared to $11.5 million in the same period of 2022. The increase was mainly due
to clinical trials expenses in our CM24 study offset by lower CMC costs in 2023.
Selling, General and Administrative Expenses
were $4.2 million, a decrease of $0.3 million, or 6.67%, compared to $4.5 million in the same period of 2022. The decrease was mainly
due to a decrease in share base payment and insurance costs.
Operating Loss was $16 million, compared to
$16 million in the same period of 2022.
On a non-IFRS basis (as reconciled below), adjusted
operating loss was $14.3 million, a decrease of $0.1 million, compared to $14.4 million in the same period of 2022.
Net Loss for the nine months ended
September 30, 2023 was $15.1 million, or $0.72 loss per basic and diluted ADS, compared to a net loss of $15.7 million, or $0.87 loss
per basic and diluted ADS, in the same period of 2022. The decrease in net loss was mainly due to an increase of $0.6 million in finance
income. Adjusted net loss for the nine months ended September 30, 2023 was $13.4 million, a decrease from $14.1 million in the
nine months ended September 30, 2022.
As of September 30, 2023, the Company had $15.9
million in cash, cash equivalents and short-term deposits. In October 2023 the Company raised an additional gross amount of $5 million
which extended the cash runway to the second half of 2025.
During the nine months ended September 30, 2023,
the Company sold, under the Open Market Sale Agreementsm with Jefferies LLC, approximately 1,040 thousand ADSs, at a weighted
average price of $1.499 per ADS. Net proceeds to the Company, were approximately $1.5 million, net of direct 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. In a Phase
1/2 study of NT219, the Company is currently advancing it in a dose escalation as a monotherapy treatment of solid tumors, and in a dose
escalation in combination with cetuximab for the treatment of recurrent and metastatic squamous cell carcinoma of the head and neck (SCCHN)
or colorectal adenocarcinoma (CRC). These studies will be followed by an expansion phase of NT219 at its recommended Phase 2 level in
combination with cetuximab in patients with recurrent and metastatic SCCHN. CM24 is a humanized monoclonal antibody that blocks CEACAM1,