Full Press Release Details
Purple Biotech Reports Third Quarter 2024 Financial
Topline data from Phase 2 CM24 pancreatic cancer
trial expected by the end of 2024
New CM24 biomarkers data presented during the
third quarter of 2024 including two predicting serum biomarkers identified and associated with CM24 novel targets
CAPTN-3 tri-specific antibody platform data
presented at the ENA Symposium October 2024
REHOVOT, Israel, November 15, 2024 -- Purple
Biotech Ltd. ("Purple Biotech" or "the Company") (NASDAQ/TASE: PPBT), a clinical-stage company developing first-in-class
therapies that overcome tumor immune evasion and drug resistance, today announced financial results for the three and nine months ended
"Marking what we believe to be the most
significant value-driving event for Purple Biotech's clinical programs to date, we are on track to complete CM24's Phase 2
study in pancreatic cancer and report topline results by the end of this year," stated Purple Biotech's CEO, Gil Efron. "The
interim Phase 2 CM24 data released so far demonstrated efficacy, and new biomarker data indicate potential to further improve outcomes
in a future study through the use of one or more serum biomarkers for patient selection. This would position CM24 as a potentially promising
CEACAM1 and Neutrophils Extracellular Trap (NET) targeted therapy. While we advance CM24 as a second line treatment for pancreatic cancer,
we are planning to address additional unmet needs in other indications based on CM24's demonstrated mechanism of action in our Phase
2 study. Our cash runway now extends into the fourth quarter of 2025. We continue to advance our clinical assets and believe we will be
soon well positioned for partnerships across our pipeline."
Q3 2024 and Recent Clinical & Corporate
New positive biomarker findings for CM24, a multi-functional
CEACAM1 inhibitor, were presented at the American Association for Cancer Research (AACR) Special Conference on Advances in Pancreatic
Cancer Research in a poster titled "Exploratory biomarker evaluation of the randomized Phase 2 cohort of CM24 in combination with
nivolumab and chemotherapy in advanced/metastatic pancreatic cancer".
The summary of findings presented at AACR include
More recent biomarker data specific to serum CEACAM1,
associated with a 79% reduction in risk of death were announced by Purple Biotech in November 2024:
PDAC patients who had pretreatment serum CEACAM1
levels between 6K and 15K pg/mL demonstrated the best outcomes following treatment with CM24 and nivolumab in combination with irinotecan/fluoropyrimidine
based chemotherapy compared to chemotherapy alone.
The Phase 2 randomized study is evaluating CM24
in combination with Bristol Myers Squibb's PD-1 inhibitor nivolumab plus standard of care (SoC) chemotherapy as a second line treatment
of patients with PDAC. In the experimental arms of the study patients were treated with CM24 plus nivolumab and one of two SoC chemotherapies,
gemcitabine/nab-paclitaxel or Nal-IRI/5FU/LV, while patients in the control arms are administered with either respective chemotherapies
alone. Sixty-three patients have been enrolled across 18 centers in the U.S., Spain and Israel. The gemcitabine/nab-paclitaxel-based part
of the study was impacted by informative censoring of the control arm that led to an imbalance between the control and experimental cohorts,
rendering this part of the study unsuitable for analysis; this part of the study has no impact on the CM24+nivolumab+Nal-IRI/5FU/LV portion
A Phase 2 study of NT219, a first-in-class, small
molecule dual inhibitor of IRS1/2 and STAT3, is planned to commence in the first half of 2025. The recommended Phase 2 dose of 100 mg/kg
was achieved in the prior Phase 1/2 dose escalation study, which demonstrated anti-tumor activity at the target exposure level and was
well tolerated in combination with cetuximab as a second line treatment of recurrent metastatic squamous cell carcinoma of the head and
New data regarding Purple Biotech's novel
tri-specific antibody platform, CAPTN-3, were presented at the 36th European Organization for Research and Treatment of Cancer, National
Cancer Institute, American Association for Cancer Research (EORTC-NCI-AACR) Symposium on Molecular Targets and Cancer Therapeutics (the
"Triple Meeting") in a poster titled "CAPTN-3: A novel platform of conditionally activated T cell and NK cell engagers".
CAPTN-3 demonstrated sustained tumor regression in a triple negative breast cancer in-vivo model as well as dose dependent activity and
synergistic effect of the engager arms in non-small cell lung cancer patient-derived explants. Purple Biotech's lead tribody candidate,
IM1240, demonstrated that cytokine release is 5T4-dependent and suppressed by the conditionally activated capping technology, suggesting
a potentially beneficial safety profile of this tribody. The data further demonstrated additional tribodies, suggesting CAPTN-3's
plug and play platform capability. Purple Biotech continues to accumulate data supporting the benefit of dual engagement of both T cells
Financial Results for the Three Months Ended
Research and Development Expenses were
$1.3 million, a decrease of $3.3 million, or 71.7%, compared to $4.6 million in the same period of 2023, mainly due to reduced clinical
Sales, General and Administrative Expenses were
$0.8 million, compared to $1.2 million in the same period of 2023, a decrease of $0.4 million, or 33.3%, mainly due to a decrease in salary
and salary related costs and share based payment expenses.
Operating Loss was $2.1 million, a decrease
of $3.6 million, or 63.2%, compared to $5.7 million in the same period of 2023, mainly due to the decrease in research and development
Adjusted Operating Loss (as
reconciled below) was $2 million, a decrease of $3.3 million, compared to $5.3 million in the same period of 2023.
Net Loss for the three months ended September
30, 2024, was $0.7 million, or $0.39 per basic and diluted ADS, compared to a net loss of $5 million, or $4.63 per basic and diluted ADS,
in the same period of 2023. The decrease in net loss was mainly due to the decrease in research and development expenses and an increase
in financial income related to changes in fair value of warrants.
Adjusted Net Loss (as reconciled below)
for the three months ended September 30, 2024, was $2.4 million, a decrease of $2.4 million or 50% compared to $4.8 million for the three
months ended September 30, 2023.
As of September 30, 2024, Purple Biotech had cash
and cash equivalents and short-term deposits of $6.3 million. Purple Biotech now has a cash runway into the fourth quarter of 2025.
During the three months ended September 30, 2024,
the Company sold, under the Open Market Sale Agreement with Jefferies LLC, approximately 76 thousand ADSs, at an average price of $6.5
per ADS. Net proceeds to the Company were approximately $0.5 million, net of issuance expenses.
Financial Results for the Nine Months Ended
Research and Development Expenses were
$7.2 million, a decrease of $4.6 million, or 39%, compared to $11.8 million in the same period of 2023. The decrease was mainly due to
reduced clinical trials expenses.
Sales, General and Administrative Expenses were
$2.6 million, a decrease of $1.6 or 38.1%, compared to $4.2 million in the same period of 2023, mainly due to a decrease in salary and
salary related expenses and share based payment expenses.
Operating Loss was $10 million, a decrease
of $6 million, or 37.5%, compared to $16 million in the same period of 2023, mainly due to the decrease in research and development expenses.
Adjusted Operating Loss (as reconciled
below) was $9.4 million, a decrease of $4.9 million, compared to $14.3 million in the same period of 2023.
Net Loss for the nine months ended September
30, 2024 was $6.9 million, or $4.57 loss per basic and diluted ADS, compared to a net loss of $15.1 million, or $14.47 loss per basic
and diluted ADS, in the same period of 2023. The decrease in net loss was mainly due to a $6 million decrease in operating expenses and
$3.3 million income from change in fair value of warrants.
Adjusted net loss (as reconciled below)
for the nine months ended September 30, 2024 was $9.5 million, compared to $13.7 million for the nine months ended September 30, 2023.
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 non-cash share-based compensation expenses and adjusted net loss also adjusts for non-cash financial instruments evaluation income.
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 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