TIDMNSCI
RNS Number : 4637Z
NetScientific PLC
15 May 2023
RNS: For immediate release
NetScientific plc
("NetScientific" or the "Company")
PDS Biotech Provides Business Update and Reports First Quarter
2023 Financial Results
Updated data from VERSATILE-002 Phase 2 trial to be presented at
ASCO 2023
NetScientific Plc (AIM: NSCI), the investment and
commercialisation group with an international portfolio of
innovative life science, sustainability and technology companies,
reports that its portfolio company, PDS Biotechnology Corporation
(Nasdaq: PDSB), a clinical-stage immunotherapy company developing a
growing pipeline of targeted immunotherapies for cancer and
infectious disease, today announced its financial results for the
quarter ended March 31, 2023.
First Quarter and Recent Business Highlights:
-- PDS0101 Lead Drug Candidate
o VERSATILE-002 Phase 2 open-label, multicentre study of PDS0101
in combination with Merck's anti-PD-1 therapy, KEYTRUDA(R)
(pembrolizumab) in patients with human papillomavirus (HPV)
16-positive recurrent and/or metastatic head and neck cancer
-- Announced poster presentation of updated data from
VERSATILE-002 trial during the 2023 American Society of Clinical
Oncology (ASCO) Annual Meeting and its selection as a featured
poster to be reviewed by an expert panel during the Head and Neck
Cancer discussion session
-- Announced plan to initiate the Phase 3 VERSATILE-003 trial,
for PDS0101 in combination with KEYTRUDA(R) in head and neck cancer
in the fourth quarter of 2023
-- Presented initial data on T cell activation and functionality
for PDS0101 in combination with KEYTRUDA(R) (pembrolizumab) at the
ESMO Targeted Anticancer Therapies Congress 2023
o National Cancer Institute (NCI)-led Phase 2 triple combination
trial in patients with advanced HPV-positive cancers
-- Reported successful meeting with U.S. Food and Drug
Administration (FDA) to discuss regulatory pathway for triple
combination of PDS0101, PDS0301, and an approved immune checkpoint
inhibitor (ICI)
-- PDS0301 Antibody-Conjugated Interleukin 12 (IL-12)
o Hosted Key Opinion Leader (KOL) event focused on the potential
use of IL-12 immunocytokine in oncology and the clinical results
demonstrated to date with PDS0301
o Announced clinical study of PDS0301 monotherapy published by
the NCI in peer-reviewed journal, International Immunopharmacology,
linking induced changes in immune responses with clinical outcomes
in advanced cancer patients
-- Infectimune(TM) Platform
o Publication of preclinical Infectimune(TM) study in the
peer-reviewed journal Viruses showed complete protection against
influenza infection in animal studies with PDS0202, a novel
investigational recombinant protein-based universal flu vaccine
o A second preclinical Infectimune(TM) publication in the
peer-reviewed journal Viruses showed induction of higher levels of
multifunctional influenza-specific CD4 T cells compared to leading
commercial vaccine technologies
-- Business Highlights
o Received $1.4 million from the net sale of net operating loss
tax benefits through the New Jersey economic development
programme
Dr Ilian Iliev, CEO of NetScientific, said:
"It has been very pleasing to see Frank and his team at PDS make
great strides as they continue with their important immunotherapy
work. It has been another productive quarter for them, as they
progress toward initiation of the upcoming Phase 3 trial,
VERSATILE-003, for PDS0101 in combination with KEYTRUDA(R) in
HPV16-positive head and neck cancer patients."
Dr Frank Bedu-Addo, President and Chief Executive Officer of PDS
Biotech stated:
"We look forward to initiating our Phase 3 trial in the fourth
quarter of this year and to provide an update on interim data from
our VERSATILE-002 Phase 2 clinical trial this June at ASCO.
Additionally, the NCI-led triple combination, IMMUNOCERV, and Mayo
Clinic neoadjuvant Phase 2 trials continue to progress.
Furthermore, we continue to develop our novel antibody-conjugated
IL-12 asset PDS0301 and look forward to providing an update on
ongoing investigator-initiated Phase 2 trials at the NCI in several
solid tumour indications."
First Quarter 2022 Financial Results
Reported net loss was approximately $9.7 million, or $0.32 per
basic share and diluted share, for the three months ended March 31,
2023, compared to a net loss of $8.5 million, or $0.32 per basic
share and diluted share, for the three months ended March 31, 2022.
The increase was due to personnel, clinical studies, medical
affairs, and manufacturing expenses.
Research and development expenses increased to approximately
$5.8 million for the three months ended March 31, 2023, from $5.2
million for the three months ended March 31, 2022. The increase of
$0.6 million in 2023 was primarily attributable to an increase of
$0.2 million in clinical studies and medical affairs, $0.8 million
in personnel costs and $0.1 million in professional fees offset by
a decrease of $0.5 million in manufacturing expenses.
General and administrative expenses increased to approximately
$3.6 million for the three months ended March 31, 2023, from
approximately $3.3 million for the three months ended March 31,
2022. The increase of $0.3 million is primarily attributable to an
increase of $0.8 million in personnel, which is offset by a
decrease of $0.5 million in professional fees.
Total operating expenses increased to approximately $9.4 million
for the three months ended March 31, 2023 from $8.5 million for the
three months ended March 31, 2022.
Cash and cash equivalents as of March 31, 2023, totalled
approximately $65.2 million. Based on the Company's cash resources
with the anticipated initiation of one registrational trial in
2023, PDS Biotech believes this balance is sufficient to fund the
Company's operations and research and development programs into the
third quarter of 2024.
A full version of PDS Biotech's announcement, including the
Condensed Consolidated Balance Sheet and Condensed Consolidated
Statements of Operations and Comprehensive Loss (Unaudited) can be
accessed here:
https://www.pdsbiotech.com/index.php/investors/news-center/press-releases/press-releases1/125-2023-news/831-iotechrovidesusinesspdateandeportsirstuar20230515
-Ends-
For more information, please contact:
NetScientific
Ilian Iliev, CEO Via Belvedere Communications
WH Ireland (NOMAD, Financial Adviser and Broker)
Chris Fielding / Darshan Patel / Enzo Aliaj +44 (0)20 7220
1666
Belvedere Communications
John West / Llew Angus +44 (0) 203 008 6867
Email: nsci@belvederepr.com
About NetScientific
NetScientific plc (AIM: NSCI) is an investment and
commercialisation group with an international portfolio of
innovative life science, sustainability and technology
companies.
NetScientific identifies, invests in, and builds high growth
companies in the UK and internationally. The company adds value
through the proactive management of its portfolio, progressing to
key value inflection points, and delivering investment returns
through partial or full liquidity events.
NetScientific differentiates itself by employing a capital-light
investment approach, making judicial use of its balance sheet and
syndicating investments through its wholly owned VC subsidiary, EMV
Capital. The group secures a mixture of direct equity stakes and
carried interest stakes in its portfolio of companies, creating a
lean structure that can support a large portfolio.
NetScientific is headquartered in London, United Kingdom, and is
admitted to trading on AIM, a market operated by the London Stock
Exchange.
www.netscientific.net
About PDS Biotechnology
PDS Biotech is a clinical-stage immunotherapy company developing
a growing pipeline of targeted cancer and infectious disease
immunotherapies based on our proprietary Versamune(R) ,
Versamune(R) plus PDS0301, and Infectimune(TM) T cell-activating
platforms and PDS0301 tumor targeting immunocytokine. We believe
our targeted immunotherapies have the potential to overcome the
limitations of current immunotherapy approaches through the
activation of the right type, quantity and potency of T cells. To
date, our lead Versamune(R) clinical candidate, PDS0101, has
demonstrated the ability to reduce tumors and stabilize disease in
combination with approved and investigational therapeutics in
patients with a broad range of HPV16-associated cancers in multiple
Phase 2 clinical trials. and will be advancing into a Phase 3
clinical trial in combination with KEYTRUDA(R) for the treatment of
recurrent/metastatic HPV16-positive head and neck cancer in 2023.
Our Infectimune(TM) based vaccines have also demonstrated the
potential to induce not only robust and durable neutralizing
antibody responses, but also powerful T cell responses, including
long-lasting memory T cell responses in pre-clinical studies to
date. To learn more, please visit www.pdsbiotech.com or follow us
on Twitter at @PDSBiotech.
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