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 Highlights:
- CM24 Pancreatic
Cancer Program Advances
- Phase 2 enrollment
ahead of schedule
- Interim results
for PFS and OS expected
in H1 2024 with topline results
expected in H2 2024
- Biomarker data supporting
MOA presented at
AACR
Patient enrollment 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.
New biomarker 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.
- NT219 Positive Phase 1/2
Interim Results in Head & Neck Cancer
- Anti-tumor activity with
confirmed partial
responses in
highest, to date, dose
cohort
- Phase 2 study is
being designed
- Fortified IP protection with
new patent
Initial anti-tumor 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 response.
A new patent was 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 September 30, 2023
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 September 30, 2023
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, 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.
IM1240 is a preclinical, conditionally-activated tri-specific
antibody that engages both T cells and NK cells to mount a strong,
localized immune response within the tumor microenvironment. The
third arm specifically targets the Tumor Associated Antigen (TAA)
5T4 that is expressed in a variety of solid tumors and is
correlated with advanced disease, increased invasiveness and poor
clinical outcomes. IM1240 has a cleavable capping technology that
confines the compound's therapeutic activity to the local tumor
microenvironment, and thereby potentially increases the anticipated
therapeutic window in patients. 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
Statement
Certain statements in this press release that are
forward-looking and not statements of historical fact are
forward-looking statements within the meaning of the safe harbor
provisions of the Private Securities Litigation Reform Act of 1995.
Such forward-looking statements include, but are not limited to,
statements that are not statements of historical fact, and may be
identified by words such as "believe", "expect", "intend", "plan",
"may", "should", "could", "might", "seek", "target", "will",
"project", "forecast", "continue" or "anticipate" or their
negatives or variations of these words or other comparable words or
by the fact that these statements do not relate strictly to
historical matters. You should not place undue reliance on these
forward-looking statements, which are not guarantees of future
performance. Forward-looking statements reflect our current views,
expectations, beliefs or intentions with respect to future events,
and are subject to a number of assumptions, involve known and
unknown risks, many of which are beyond our control, as well as
uncertainties and other factors that may cause our actual results,
performance or achievements to be significantly different from any
future results, performance or achievements expressed or implied by
the forward-looking statements. Important factors that could cause
or contribute to such differences include, among others, risks
relating to: the plans, strategies and objectives of management for
future operations; product development for NT219, CM24 and IM1240;
the process by which such early stage therapeutic candidates could
potentially lead to an approved drug product is long and subject to
highly significant risks, particularly with respect to a joint
development collaboration; the fact that drug development and
commercialization involves a lengthy and expensive process with
uncertain outcomes; our ability to successfully develop and
commercialize our pharmaceutical products; the expense, length,
progress and results of any clinical trials; the impact of any
changes in regulation and legislation that could affect the
pharmaceutical industry; the difficulty in receiving the regulatory
approvals necessary in order to commercialize our products; the
difficulty of predicting actions of the U.S. Food and Drug
Administration or any other applicable regulator of pharmaceutical
products; the regulatory environment and changes in the health
policies and regimes in the countries in which we operate; the
uncertainty surrounding the actual market reception to our
pharmaceutical products once cleared for marketing in a particular
market; the introduction of competing products; patents obtained by
competitors; dependence on the effectiveness of our patents and
other protections for innovative products; our ability to obtain,
maintain and defend issued patents; the commencement of any patent
interference or infringement action against our patents, and our
ability to prevail, obtain a favorable decision or recover damages
in any such action; and the exposure to litigation, including
patent litigation, and/or regulatory actions, and other factors
that are discussed in our Annual Report on Form 20-F for the year
ended December 31, 2022 and in our other filings with the U.S.
Securities and Exchange Commission ("SEC"), including our
cautionary discussion of risks and uncertainties under "Risk
Factors" in our Registration Statements and Annual Reports. These
are factors that we believe could cause our actual results to
differ materially from expected results. Other factors besides
those we have listed could also adversely affect us. Any
forward-looking statement in this press release speaks only as of
the date which it is made. We disclaim any intention or obligation
to publicly update or revise any forward-looking statement or other
information contained herein, whether as a result of new
information, future events or otherwise, except as required by
applicable law. You are advised, however, to consult any additional
disclosures we make in our reports to the SEC, which are available
on the SEC's website, https://www.sec.gov.
CONTACTS:
Company Contact:Lior FhimaChief Financial
OfficerIR@purple-biotech.com
Purple Biotech Ltd.
Consolidated Unaudited Statements of Financial Position
as of:
|
|
September 30, |
|
|
December 31, |
|
|
|
2023 |
|
|
2022 |
|
|
|
USD thousand |
|
|
USD thousand |
|
Assets |
|
|
|
|
|
|
Cash and cash equivalents |
15,104 |
|
|
15,030 |
|
Short term deposits |
842 |
|
|
16,652 |
|
Other investments |
138 |
|
|
431 |
|
Other current assets |
634 |
|
|
1,143 |
|
|
|
|
|
|
|
|
Total current assets |
16,718 |
|
|
33,256 |
|
|
|
|
|
|
|
|
Non-current assets |
|
|
|
|
|
Right of use assets |
354 |
|
|
467 |
|
Fixed assets, net |
156 |
|
|
215 |
|
Intangible assets |
28,044 |
|
|
20,684 |
|
|
|
|
|
|
|
|
Total non–current assets |
28,554 |
|
|
21,366 |
|
|
|
|
|
|
|
|
Total assets |
45,272 |
|
|
54,622 |
|
|
|
|
|
|
|
|
Liabilities |
|
|
|
|
|
Lease liability - short term |
178 |
|
|
194 |
|
Accounts payable |
2,593 |
|
|
2,132 |
|
Other payables |
3,449 |
|
|
4,732 |
|
|
|
|
|
|
|
|
Total current liabilities |
6,220 |
|
|
7,058 |
|
|
|
|
|
|
|
|
Non-current liabilities |
|
|
|
|
|
Lease liability |
192 |
|
|
321 |
|
Post-employment benefit liabilities |
141 |
|
|
145 |
|
|
|
|
|
|
|
|
Total non-current liabilities |
333 |
|
|
466 |
|
|
|
|
|
|
|
|
Equity |
|
|
|
|
|
|
Share capital, no par value |
- |
|
|
- |
|
Share premium |
133,024 |
|
|
126,407 |
|
Receipts on account of warrants |
28,017 |
|
|
28,017 |
|
Capital reserve for share-based payments |
|
10,284 |
|
|
10,164 |
|
Capital reserve from transactions with related parties |
|
761 |
|
|
761 |
|
Capital reserves from hedging |
(2 |
) |
|
(6 |
) |
Capital reserve from transactions with non-controlling |
|
|
|
|
interest |
|
(859 |
) |
|
(859 |
) |
Accumulated loss |
(132,627 |
) |
|
(117,573 |
) |
|
|
|
|
|
|
|
Equity attributable to owners of the Company |
|
38,598 |
|
|
46,911 |
|
Non-controlling interests |
121 |
|
|
187 |
|
|
|
|
|
|
|
|
Total equity |
38,719 |
|
|
47,098 |
|
|
|
|
|
|
|
|
Total liabilities and equity |
45,272 |
|
|
54,622 |
|
|
Purple Biotech Ltd.
Consolidated Unaudited Statement of Operations for
the nine and
three months ended
September
30,
2023
|
|
|
|
For the nine months ended September 30, |
For the three months ended September 30, |
|
|
|
2023 |
|
|
2022 |
|
|
2023 |
|
|
2022 |
|
|
|
|
USD thousand |
|
|
USD thousand |
|
|
USD thousand |
|
|
USD thousand |
|
|
|
|
|
|
|
Research and development expenses |
|
11,792 |
|
|
11,500 |
|
|
4,589 |
|
|
3,465 |
|
Sales, general and administrative expenses |
|
4,212 |
|
|
4,502 |
|
|
1,158 |
|
|
1,616 |
|
|
|
|
|
|
|
Operating loss |
|
16,004 |
|
|
16,002 |
|
|
5,747 |
|
|
5,081 |
|
|
|
|
|
|
|
Finance expense |
|
223 |
|
|
108 |
|
|
16 |
|
|
16 |
|
Finance income |
|
(1,109 |
) |
|
(393 |
) |
|
(708 |
) |
|
(248 |
) |
|
|
|
|
|
|
Finance expense (income), net |
|
(886 |
) |
|
(285 |
) |
|
(692 |
) |
|
(232 |
) |
|
|
|
|
|
|
Loss for the period |
|
15,118 |
|
|
15,717 |
|
|
5,055 |
|
|
4,849 |
|
|
|
|
|
|
|
Other Comprehensive Loss: |
|
|
|
|
|
Items that will be transferred to profit |
|
|
|
|
|
or loss: |
|
|
|
|
|
Loss (Profit) on cash flow hedges |
|
(4 |
) |
|
17 |
|
|
- |
|
|
(4 |
) |
|
|
|
|
|
|
Total comprehensive loss for the period |
|
15,114 |
|
|
15,734 |
|
|
5,055 |
|
|
4,845 |
|
|
|
|
|
|
|
Loss attributable to: |
|
|
|
|
|
Owners of the Company |
|
15,052 |
|
|
15,657 |
|
|
5,036 |
|
|
4,824 |
|
Non-controlling interests |
|
66 |
|
|
60 |
|
|
19 |
|
|
25 |
|
|
|
|
|
|
|
|
|
15,118 |
|
|
15,717 |
|
|
5,055 |
|
|
4,849 |
|
|
|
|
|
|
|
Total comprehensive loss attributable
to |
|
|
|
|
|
Owners of the Company |
|
15,048 |
|
|
15,674 |
|
|
5,036 |
|
|
4,820 |
|
Non-controlling interests |
|
66 |
|
|
60 |
|
|
19 |
|
|
25 |
|
|
|
|
|
|
|
|
|
15,114 |
|
|
15,734 |
|
|
5,055 |
|
|
4,845 |
|
|
|
|
|
|
|
Loss per share data |
|
|
|
|
|
Basic and diluted loss per ADS - USD |
|
0.72 |
|
|
0.87 |
|
|
0.23 |
|
|
0.27 |
|
|
|
|
|
|
|
Number of ADSs used in calculation |
|
20,901,078 |
|
|
17,977,244 |
|
|
21,836,454 |
|
|
18,073,331 |
|
|
|
|
|
|
|
Reconciliation of Adjusted Operating Loss
|
|
|
For the nine
months ended September
30,
|
|
For the three months ended
September 30,
|
|
|
|
2023
|
|
|
2022
|
|
|
2023
|
|
|
2022
|
|
|
|
|
USD thousand
|
|
USD thousand
|
|
USD thousand
|
|
USD thousand
|
|
|
|
|
|
|
|
Operating loss for the
period
|
|
|
16,004
|
|
|
16,002
|
|
|
5,747
|
|
|
5,081
|
|
Less ESOP expenses
|
|
|
(1,694
|
)
|
|
(1,573
|
)
|
|
(449
|
)
|
|
(707
|
)
|
|
|
|
14,310
|
|
|
14,429
|
|
|
5,298
|
|
|
4,374
|
|
|
Reconciliation of Adjusted Net Loss
|
|
|
For the nine
months ended September
30,
|
For the three months ended
September 30,
|
|
|
|
2023
|
|
|
2022
|
|
|
2023
|
|
|
2022
|
|
|
|
|
USD thousand
|
|
USD thousand
|
|
USD thousand
|
|
USD thousand
|
|
|
|
|
|
|
|
Loss for the
period
|
|
|
15,118
|
|
|
15,717
|
|
|
5,055
|
|
|
4,849
|
|
Less ESOP expenses
|
|
|
(1,694
|
)
|
|
(1,573
|
)
|
|
(449
|
)
|
|
(707
|
)
|
|
|
|
13,424
|
|
|
14,144
|
|
|
4,606
|
|
|
4,142
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Consolidated Unaudited Statements of
Cash Flow
|
For the nine months ended September 30,
|
|
2023 |
|
|
2022 |
|
|
USD thousand |
|
|
USD thousand |
|
Cash flows from operating activities: |
|
|
|
|
|
Loss for the period |
(15,118 |
) |
|
(15,717 |
) |
Adjustments: |
|
|
|
|
|
Depreciation |
149 |
|
|
151 |
|
Finance income, net |
(886 |
) |
|
(285 |
) |
Share-based payments |
1,694 |
|
|
1,573 |
|
|
|
|
|
|
|
|
(14,161 |
) |
|
(14,278 |
) |
|
|
|
|
|
|
Changes in assets and liabilities: |
|
|
|
|
|
Changes in other investments and other current assets |
219 |
|
|
(124 |
) |
Changes in accounts payables |
415 |
|
|
1,534 |
|
Changes in other payables |
(1,255 |
) |
|
495 |
|
Changes in post-employment benefit liabilities |
(161 |
) |
|
(148 |
) |
|
|
|
|
|
|
|
(782 |
) |
|
1,757 |
|
|
|
|
|
|
|
Net cash used in operating activities |
(14,943 |
) |
|
(12,521 |
) |
|
|
|
|
|
|
Cash flows from investing activities: |
|
|
|
|
|
Acquisition of subsidiary, net of cash acquired |
(3,549 |
) |
|
- |
|
Proceed from other investments |
875 |
|
|
- |
|
Acquisition of intangible asset |
- |
|
|
(202 |
) |
Interest received |
675 |
|
|
324 |
|
Decrease (increase) in short-term deposits |
15,809 |
|
|
(2,481 |
) |
Decrease in long-term deposits |
- |
|
|
14,300 |
|
Acquisition of fixed assets |
(3 |
) |
|
(26 |
) |
|
|
|
|
|
|
Net cash provided by investing activities |
13,807 |
|
|
11,915 |
|
|
|
|
|
|
|
Cash flows from financing activities: |
|
|
|
|
|
Proceeds from issuance ADSs |
1,559 |
|
|
1,312 |
|
ADS issuance expenses paid |
(188 |
) |
|
(114 |
) |
Repayment of lease liability |
(126 |
) |
|
(124 |
) |
Interest paid |
(42 |
) |
|
(49 |
) |
|
|
|
|
|
|
Net cash provided by financing activities |
1,203 |
|
|
1,025 |
|
|
|
|
|
|
|
Net increase in cash and cash equivalents |
67 |
|
|
419 |
|
Cash and cash equivalents at the beginning of the period |
15,030 |
|
|
10,890 |
|
Effect of translation adjustments on cash and cash equivalents |
7 |
|
|
(235 |
) |
|
|
|
|
|
|
Cash and cash equivalents at the end of the
period |
15,104 |
|
|
11,074 |
|
|
|
|
|
|
|
Purple Biotech (NASDAQ:PPBT)
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