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 second
quarter and six months ended June 30, 2023.
“During the second quarter of 2023 we continued
to advance our lead clinical programs, CM24 in the treatment of
pancreatic cancer and NT219 for head and neck cancer, while
prudently managing our development and operating expenses. Our
financial results in the first half of 2023 represent our clinical
trials’ progress with recruitment at a pace faster than expected in
our CM24 study. As we reprioritize our objectives from time to
time, we have extended our cash runway into the first half of
2025,” stated Purple Biotech CEO, Gil Efron.
“In the coming months, we look forward to
announcing milestones including interim data from our randomized
Phase 2 CM24 study as well as results from our Phase 1 NT219 dose
escalation study. In addition, we are excited to commence work on
IM1240, our newly acquired tri-specific antibody.”
“I am excited to return to working with our
dedicated team after my medical leave. I would like to thank Isaac
Israel, the management, and our employees for their great work
during my absence,” Gil Efron added.
Financial Results for the three Months
Ended June 30, 2023
Research and Development
Expenses were $3.7 million, an increase of $1.7 million or
85%, compared to $2 million in the same period of 2022 mainly due
to higher enrollment rate to our clinical trials.
Selling, General and Administrative
Expenses were $1.4 million, a decrease of $0.1 million or
7%, compared to $1.5 million in the same period of 2022.
Operating Loss was $5.1
million, an increase of $1.5 million or 42% compared to $3.6
million in the same period of 2022 mainly due to higher research
and development expenses.
On a non-IFRS basis (as reconciled
below), adjusted operating loss was $4.6
million, an increase of $1.6 million or 53%, compared to $3 million
in the same period of 2022 mainly due to higher research and
development expenses.
Net Loss for the three
months ended June 30, 2023 was $5.2 million, or $0.25 loss per
basic and diluted ADS, compared to a net loss of $3.6 million, or
$0.2 loss per basic and diluted ADS, in the three months ended June
30, 2022. Adjusted net loss for the three months
ended June 30, 2023 was $4.7 million, an increase of $1.7 million
or 57% compared to $3 million in the three months ended June 30,
2022.
Financial Results for the Six Months
Ended June 30, 2023
Research and Development
Expenses were $7.2 million, a decrease of $0.8 million, or
10%, compared to $8 million in the same period of 2022. The
decrease was mainly due to a decrease of $3.4 million in chemistry,
manufacturing, and controls (CMC) expenses representing batch
manufacturing in 2022, offset by an increase of $2 million in
clinical expenses and $0.6 million in other research and
development expenses in support of our growing clinical and
development activities.
Sales, General and Administrative
Expenses were $3.0 million, compared to $2.9 million in
the same period of 2022, an increase of $0.1 million.
Operating Loss was $10.3
million, a decrease of $0.6 million, or 6%, compared to $10.9
million in the same period of 2022.
On a non-IFRS basis (as reconciled
below), adjusted operating loss was $9
million, a decrease of $1 million, compared to $10 million in the
same period of 2022, mainly due to a decrease in research and
development expenses.
Net Loss for the six
months ended June 30, 2023 was $10.0 million, or $0.49 loss per
basic and diluted ADS, compared to a net loss of $10.9 million, or
$0.61 loss per basic and diluted ADS, in the same period of 2022.
The decrease in net loss was mainly due to a decrease of $0.6
million in operating expenses. Adjusted net loss
for the six months ended June 30, 2023 was $8.8 million, a decrease
from $10.0 million in the six months ended June 30, 2022.
As of June 30, 2023, Purple Biotech had cash and
cash equivalents and short-term deposits of $18.0 million. This
cash position provides a cash runway into the first half of
2025.
During the six months ended June 30, 2023, the
Company sold, under the Open Market Sale Agreementsm with Jefferies
LLC, approximately 479,000 ADSs, at an average price of $1.83 per
ADS. Net proceeds to the Company were approximately $0.85 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 Fhima Chief Financial Officer
IR@purple-biotech.com Purple Biotech Ltd.
Consolidated Unaudited Statements of Financial Position as
of: |
|
|
June 30, |
|
|
December
31, |
|
|
|
2023 |
|
|
2022 |
|
|
|
USD
thousand |
|
|
USD
thousand |
|
Assets |
|
|
|
|
|
|
Cash and cash equivalents |
|
|
17,202 |
|
|
|
15,030 |
|
Short term
deposits |
|
|
846 |
|
|
|
16,652 |
|
Other
investments |
|
|
352 |
|
|
|
431 |
|
Other
current assets |
|
|
984 |
|
|
|
1,143 |
|
|
|
|
|
|
|
|
|
|
Total
current assets |
|
|
19,384 |
|
|
|
33,256 |
|
|
|
|
|
|
|
|
|
|
Non-current assets |
|
|
|
|
|
|
|
|
Right of use
assets |
|
|
392 |
|
|
|
467 |
|
Fixed
assets, net |
|
|
179 |
|
|
|
215 |
|
Intangible
assets |
|
|
28,044 |
|
|
|
20,684 |
|
|
|
|
|
|
|
|
|
|
Total
non–current assets |
|
|
28,615 |
|
|
|
21,366 |
|
|
|
|
|
|
|
|
|
|
Total
assets |
|
|
47,999 |
|
|
|
54,622 |
|
|
|
|
|
|
|
|
|
|
Liabilities |
|
|
|
|
|
|
|
|
Lease
liability - short term |
|
|
184 |
|
|
|
194 |
|
Accounts
payable |
|
|
1,572 |
|
|
|
2,132 |
|
Other
payables |
|
|
3,120 |
|
|
|
4,732 |
|
|
|
|
|
|
|
|
|
|
Total
current liabilities |
|
|
4,876 |
|
|
|
7,058 |
|
|
|
|
|
|
|
|
|
|
Non-current liabilities |
|
|
|
|
|
|
|
|
Lease
liability |
|
|
237 |
|
|
|
321 |
|
Post-employment benefit liabilities |
|
|
141 |
|
|
|
145 |
|
|
|
|
|
|
|
|
|
|
Total
non-current liabilities |
|
|
378 |
|
|
|
466 |
|
|
|
|
|
|
|
|
|
|
Equity |
|
|
|
|
|
|
|
|
Share
capital, no par value |
|
|
- |
|
|
|
- |
|
Share
premium |
|
|
132,245 |
|
|
|
126,407 |
|
Receipts on
account of warrants |
|
|
28,017 |
|
|
|
28,017 |
|
Capital
reserve for share-based payments |
|
|
10,032 |
|
|
|
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 |
|
|
(127,589 |
) |
|
|
(117,573 |
) |
|
|
|
|
|
|
|
|
|
Equity
attributable to owners of the Company |
|
|
42,605 |
|
|
|
46,911 |
|
Non-controlling interests |
|
|
140 |
|
|
|
187 |
|
|
|
|
|
|
|
|
|
|
Total
equity |
|
|
42,745 |
|
|
|
47,098 |
|
|
|
|
|
|
|
|
|
|
Total
liabilities and equity |
|
|
47,999 |
|
|
|
54,622 |
|
Purple Biotech Ltd.
Consolidated Unaudited Statement of Operations for the six
and three months ended June 30, 2023 |
|
|
For the six months ended June 30, |
|
|
For the three months ended June 30, |
|
|
|
2023 |
|
|
2022 |
|
|
2023 |
|
|
2022 |
|
|
|
USD
thousand |
|
|
USD
thousand |
|
|
USD
thousand |
|
|
USD
thousand |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development expenses |
|
|
7,203 |
|
|
|
8,035 |
|
|
|
3,705 |
|
|
|
2,083 |
|
Sales,
general and administrative expenses |
|
|
3,054 |
|
|
|
2,886 |
|
|
|
1,430 |
|
|
|
1,507 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating
loss |
|
|
10,257 |
|
|
|
10,921 |
|
|
|
5,135 |
|
|
|
3,590 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Finance
expense |
|
|
207 |
|
|
|
92 |
|
|
|
148 |
|
|
|
51 |
|
Finance
income |
|
|
(401 |
) |
|
|
(145 |
) |
|
|
(123 |
) |
|
|
(89 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Finance
expense (income), net |
|
|
(194 |
) |
|
|
(53 |
) |
|
|
25 |
|
|
|
(38 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss for
the period |
|
|
10,063 |
|
|
|
10,868 |
|
|
|
5,160 |
|
|
|
3,552 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other
Comprehensive Loss: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Items
that will be transferred to profit or loss: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss
(Profit) on cash flow hedges |
|
|
(4 |
) |
|
|
21 |
|
|
|
(5 |
) |
|
|
21 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
comprehensive loss for the period |
|
|
10,059 |
|
|
|
10,889 |
|
|
|
5,155 |
|
|
|
3,573 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss
attributable to: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Owners of
the Company |
|
|
10,016 |
|
|
|
10,833 |
|
|
|
5,138 |
|
|
|
3,536 |
|
Non-controlling interests |
|
|
47 |
|
|
|
35 |
|
|
|
22 |
|
|
|
16 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
10,063 |
|
|
|
10,868 |
|
|
|
5,160 |
|
|
|
3,552 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
comprehensive loss attributable to |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Owners of
the Company |
|
|
10,012 |
|
|
|
10,854 |
|
|
|
5,133 |
|
|
|
3,557 |
|
Non-controlling interests |
|
|
47 |
|
|
|
35 |
|
|
|
22 |
|
|
|
16 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
10,059 |
|
|
|
10,889 |
|
|
|
5,155 |
|
|
|
3,573 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss per
share data |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and
diluted loss per ADS - USD |
|
|
0.49 |
|
|
|
0.61 |
|
|
|
0.25 |
|
|
|
0.2 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Number of
ADSs used in calculation |
|
|
20,425,638 |
|
|
|
17,897,681 |
|
|
|
21,006,218 |
|
|
|
17,981,754 |
|
Reconciliation of Adjusted Operating Loss |
|
|
For the six months ended June 30, |
|
|
For the three months ended June 30, |
|
|
|
2023 |
|
|
2022 |
|
|
2023 |
|
|
2022 |
|
|
|
USD
thousand |
|
|
USD
thousand |
|
|
USD
thousand |
|
|
USD
thousand |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating loss for the period |
|
|
10,257 |
|
|
|
10,921 |
|
|
|
5,135 |
|
|
|
3,590 |
|
Less ESOP
expenses |
|
|
(1,245 |
) |
|
|
(866 |
) |
|
|
(493 |
) |
|
|
(557 |
) |
|
|
|
9,012 |
|
|
|
10,055 |
|
|
|
4,642 |
|
|
|
3,033 |
|
Reconciliation of Adjusted Net
Loss
|
|
For the six months ended June 30, |
|
|
For the three months ended June 30, |
|
|
|
2023 |
|
|
2022 |
|
|
2023 |
|
|
2022 |
|
|
|
USD
thousand |
|
|
USD
thousand |
|
|
USD
thousand |
|
|
USD
thousand |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss for the period |
|
|
10,063 |
|
|
|
10,868 |
|
|
|
5,160 |
|
|
|
3,552 |
|
Less ESOP
expenses |
|
|
(1,245 |
) |
|
|
(866 |
) |
|
|
(493 |
) |
|
|
(557 |
) |
|
|
|
8,818 |
|
|
|
10,002 |
|
|
|
4,667 |
|
|
|
2,995 |
|
Consolidated Unaudited Statements of Cash
Flow |
|
|
For the six months ended June 30, |
|
|
|
2023 |
|
|
2022 |
|
|
|
USD
thousand |
|
|
USD
thousand |
|
Cash
flows from operating activities: |
|
|
|
|
|
|
Loss for the period |
|
|
(10,063 |
) |
|
|
(10,868 |
) |
Adjustments: |
|
|
|
|
|
|
|
|
Depreciation |
|
|
99 |
|
|
|
104 |
|
Finance
expenses (income), net |
|
|
(194 |
) |
|
|
(53 |
) |
Share-based
payments |
|
|
1,245 |
|
|
|
866 |
|
|
|
|
|
|
|
|
|
|
|
|
|
(8,913 |
) |
|
|
(9,951 |
) |
|
|
|
|
|
|
|
|
|
Changes
in assets and liabilities: |
|
|
|
|
|
|
|
|
Changes in
other investments and other current assets |
|
|
(118 |
) |
|
|
(286 |
) |
Changes in
accounts payables |
|
|
(628 |
) |
|
|
(90 |
) |
Changes in
other payables |
|
|
(1,467 |
) |
|
|
1,427 |
|
Changes in
post-employment benefit liabilities |
|
|
(161 |
) |
|
|
- |
|
|
|
|
|
|
|
|
|
|
|
|
|
(2,374 |
) |
|
|
1,051 |
|
|
|
|
|
|
|
|
|
|
Net cash
used in operating activities |
|
|
(11,287 |
) |
|
|
(8,900 |
) |
|
|
|
|
|
|
|
|
|
Cash
flows from investing activities: |
|
|
|
|
|
|
|
|
Acquisition
of subsidiary, net of cash acquired |
|
|
(3,549 |
) |
|
|
- |
|
Acquisition
of intangible asset |
|
|
- |
|
|
|
(203 |
) |
Interest
received |
|
|
548 |
|
|
|
143 |
|
Decrease in
short-term deposits |
|
|
15,806 |
|
|
|
14,300 |
|
Increase in
long-term deposits |
|
|
- |
|
|
|
(2,482 |
) |
Acquisition
of fixed assets |
|
|
(4 |
) |
|
|
(20 |
) |
|
|
|
|
|
|
|
|
|
Net cash
provided by investing activities |
|
|
12,801 |
|
|
|
11,738 |
|
|
|
|
|
|
|
|
|
|
Cash
flows from financing activities: |
|
|
|
|
|
|
|
|
Proceeds
from issuance ADSs |
|
|
881 |
|
|
|
653 |
|
ADS issuance
expenses paid |
|
|
(137 |
) |
|
|
(81 |
) |
Repayment of
lease liability |
|
|
(84 |
) |
|
|
(83 |
) |
Interest
paid |
|
|
(29 |
) |
|
|
(33 |
) |
|
|
|
|
|
|
|
|
|
Net cash
provided by financing activities |
|
|
631 |
|
|
|
456 |
|
|
|
|
|
|
|
|
|
|
Net
increase (decrease) in cash and cash equivalents |
|
|
2,145 |
|
|
|
3,294 |
|
Cash and
cash equivalents at the beginning of the period |
|
|
15,030 |
|
|
|
10,890 |
|
Effect of
translation adjustments on cash and cash equivalents |
|
|
27 |
|
|
|
(178 |
) |
|
|
|
|
|
|
|
|
|
Cash and
cash equivalents at the end of the period |
|
|
17,202 |
|
|
|
14,006 |
|
Purple Biotech (NASDAQ:PPBT)
Gráfica de Acción Histórica
De May 2024 a Jun 2024
Purple Biotech (NASDAQ:PPBT)
Gráfica de Acción Histórica
De Jun 2023 a Jun 2024