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Purple Biotech Issues Letter to Shareholders

Key Takeaway: Purple Biotech Issues Letter to Shareholders REHOVOT, Israel, Feb. 04, 2022 (GLOBE NEWSWIRE) -- Purple Biotech Ltd. ("Purple Biotech", or the "Company") (NASDAQ/TASE: PPBT), a clinical-stage company developing first-in-class, effective and durable therapies by overcoming tumor

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Purple Biotech Issues Letter to Shareholders
REHOVOT, Israel, Feb. 04, 2022 (GLOBE NEWSWIRE) -- Purple Biotech Ltd.
("Purple Biotech", or the "Company") (NASDAQ/TASE: PPBT), a clinical-stage company developing first-in-class, effective
and durable therapies by overcoming tumor immune evasion and drug resistance, is pleased to issue the following letter from its Chief
Executive Officer, Isaac Israel, to its shareholders.
I look back at 2021 proudly as a foundation-setting
year for Purple Biotech, one with clinical development achievements, personnel and culture advancements. Through our collaborations, products
and people, we continue to advocate for and work towards the realization of our mission to move individuals from cancer patients to cancer
survivors. I am pleased with the meaningful progress we have made toward our goals and want to take this moment to share highlights of
Our strategic approach continues to be the development of cancer treatments addressing not only the tumor itself but also the tumor microenvironment
to improve patient outcomes. We believe our vision and passion for viewing cancer treatment through a lens focused within the components
of the tumor microenvironment allows us to be well-positioned for a differentiated and successful clinical outcome.
2022 will continue to be a year of clinical
development emphasis for our pipeline assets. Our preliminary trial data in 2021 allowed significant learnings for building this year,
creating new opportunities for advancing our primary assets with the expansion of trial arms for both product candidates.
We have entered a pivotal year for our lead assets, CM24 and NT219. As we look back on 2021, our clinical development has progressed as
anticipated, with encouraging initial data readouts from both of our lead candidates, to be articulated at upcoming major medical meetings.
Current clinical development of these programs will continue as planned in 2022. Furthermore, we plan to expand the programs into new
indications and share data milestones at the appropriate venues in 2022.
With CM24, our first-in-class
clinical stage mAb targeting CEACAM1, we will deliver our Phase 1b data readout at an upcoming medical conference. Further, we have announced
a planned expansion arm for RP2D, initiated in Q1 of 2022.
CM24 continues to be an exciting program
for Purple Biotech. We are encouraged by the initial data released during ESMO 2021 from our ongoing Phase 1b/2 clinical trial of CM24
in combination with nivolumab, demonstrating safety and a partial response in a 3rd line pancreatic cancer patient, one of
the first three patients treated with the first dose level. Purple Biotech continues to lead the field of CEACAM1-targeted therapies with
the most advanced clinical asset in this area. In 2022, we will look to study CM24 in combination with other agents, in patients with
other types of cancers, in addition to the current arms in NSCLC and pancreatic cancer.
Considering NT219, our first-in-class novel small molecule targeting
IRS1/2 and STAT3 simultaneously, we anticipate a readout on our Phase 1 monotherapy data in the first half of this year. This data will
build on our data milestone release from ASCO 2021, which presented a partial response in one patient in the first three patients treated
with the first and the lowest dose level. Following the completion of the third dose level in the monotherapy arm, we initiated the dose
escalation arm to treat squamous cell carcinoma head and neck (SCCHN) as well as colorectal cancer patients with NT219 in combination
with cetuximab. In addition, the expansion arm on RP2D in combination with cetuximab in SCCHN patients will initiate in 2022.
Later in the year, we plan to expand the evaluation of NT219 in combination
with other treatments in other cancer patients.
We believe that NT219 has the potential
to be a key anti-cancer agent addressing the drug resistance phenotype. Purple Biotech continues to be the first and leading company to
successfully target the IRS protein to degradation and focused on a dual-inhibition MOA approach of both IRS and STAT3.
Collaborations and partnerships continue to be a strong element of
our development strategy. In 2021, we maintained our partnership with Bristol Myers-Squibb to advance CM24 in combination with nivolumab
toward saturating doses, with the target of expansion into NSCLC and pancreatic cancer. This important relationship has facilitated our
Phase 1b/2 trial, combining CM24 with nivolumab and nab-paclitaxel with such patients.
In October, we announced the expansion of our existing research agreement
with The University of Texas MD Anderson Cancer Center to evaluate the potential efficacy of the combination of NT219 and immune-oncology
drugs, such as anti-CTLA4 and anti-PD1/PDL1 antibodies. This collaboration, led by Menashe Bar-Eli, Ph.D., Professor, Department of Cancer
Biology, is an important step in potentially advancing NT219 in the clinic to treat advanced solid tumors. We look forward to continuing
this partnership in 2022.
Our people are and will continue to be our most valued resource, and
we recognize the value that the right expertise brings to our scientific advancement. I continue to be inspired by the commitment of our
management to our mission and their leadership of our strong team of exceptional talent.
We enter 2022 with increased expertise, appointing Robert Gagnon, Suzana
Nahum-Zilberberg and Ori Hershkovitz to our Board of Directors in the past year. Each brings experience in industry and development essential
to our success as we enter 2022.
This year we promoted Gil Efron to President and CFO role, taking a
leadership role in the management of the company, responsible for driving the vision and execution of the company business strategy, business
development and product development.
Additionally, we are thrilled to have appointed Fabien Sebille, Ph.D.,
to Chief Business Officer. Dr. Sebille is responsible for advancing our corporate business development strategy, including partnering
opportunities for our lead candidates, CM24 and NT219 and the search for in-licensing opportunities for additional oncology assets to
diversify our development pipeline.
2021 continued to see the impact of COVID-19. As Delta and Omicron
presented a challenge to all companies, we are pleased to have encountered only minor impact on our clinical development pipeline and
trials. Our ability to pivot has allowed our clinical development programs to promptly progress. Our clinical development, including our
CM24 and NT219 programs, will continue as planned in 2022.
We enter 2022 with a solid financial position within $47.5M cash reserves
as of December 31, 2021, with 17.8M ADS outstanding. This strong position provides a cash runway into 2024.
We believe that 2022 will be a monumental year for Purple Biotech.
As we continue to advance our clinical pipeline and focus on oncology, we believe our resilience and ability to persevere through 2021
while growing our leadership and expertise positions us well for potentially significant milestones in 2022.
I want to acknowledge our shareholders, leadership, Board of Directors
and employees. Throughout the past year, your support and efforts have directly contributed to the company, our position, and our future.
Further, I would like to acknowledge our patients. Your strength and fortitude inspire and motivate us to create successful, long-lasting
treatments for people with cancer.
Chief Executive Officer
About Purple Biotech
Purple Biotech Ltd. is a clinical-stage company
developing first-in-class therapies by overcoming tumor immune evasion and drug resistance. The Company's oncology pipeline includes NT219
and CM24. NT219 is a dual inhibitor, novel small molecule that simultaneously targets IRS1/2 and STAT3. The Company is currently advancing
NT219 as a monotherapy treatment of solid tumors, followed by a dose escalation of NT219 in combination with cetuximab for the treatment
of recurrent and/or metastatic squamous cell carcinoma of the head and neck cancer (SCCHN) or colorectal adenocarcinoma in a phase 1/2
study, and an expansion phase of NT219 at its recommended phase 2 level in combination with cetuximab in patients with recurrent and/or
metastatic squamous cell carcinoma of the head and neck cancer. 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 selected cancer indications in a phase 1b study followed by a phase 2 for the treatment
of non-small cell lung cancer and pancreatic cancer. The Company has entered into a clinical collaboration agreement, as amended, with
Bristol Myers Squibb for the planned phase 1/2 clinical trials to evaluate the combination of CM24 with the PD-1 inhibitor nivolumab (Opdivo )
in patients with non-small cell lung cancer and in combination with nivolumab in addition to nab-paclitaxel (ABRAXANE ) in patients
with pancreatic cancer. The Company is also the owner of Consensi , an FDA-approved fixed-dose combination of celecoxib and amlodipine
besylate, for the simultaneous treatment of osteoarthritis pain and hypertension that was approved by the FDA for marketing in the U.S.
The Company's corporate headquarters are located in Rehovot, Israel. For more information, please visit https://www.purple-biotech.com.
Forward-Looking Statements and Safe Harbor Statement
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
Last updated: Feb 4, 2022