PDS Business Update and First Quarter Results
15/05/2023 15:16
For best results when printing this announcement, please click on link below:
http://newsfile.refinitiv.com/getnewsfile/v1/story?guid=urn:newsml:reuters.com:20230515:nRSO4637Za&default-theme=true
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(®) (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(®) 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(®) (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,
(https://linkprotect.cudasvc.com/url?a=https%3a%2f%2fpdsbiotech.us4.list-manage.com%2ftrack%2fclick%3fu%3d407bd594246e0ad6fd93882af%26id%3d6fef13dd31%26e%3d27d88613f0&c=E,1,pX0VS9V1MidjZubgX-CV_a4Xxr6LL6qJwaWQgotFtvG91Cuj2UKvK6OuE5fTDqJmsGZiwe5q7un78m1sv8g9dvBkL59B53gvVAPxnLzgLC56cA,,&typo=1)
linking induced changes in immune responses with clinical outcomes in advanced
cancer patients
· Infectimune™ Platform
o Publication of preclinical Infectimune™ study in the peer-reviewed
journal Viruses
(https://linkprotect.cudasvc.com/url?a=https%3a%2f%2fpdsbiotech.us4.list-manage.com%2ftrack%2fclick%3fu%3d407bd594246e0ad6fd93882af%26id%3d126de3074a%26e%3d27d88613f0&c=E,1,hEA_X7JCkwEMOedsyNGKmXneaDFxP3YOJaDq4mFI7hUKWDIwNdjj5AtYY7E6RslSyZ_Pokz6VgyOvrUH3OOqcwpBXXENx8ybOGsNTWHzfquTFI7B8RKJ5PJ1&typo=1)
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™ publication in the peer-reviewed
journal Viruses
(https://linkprotect.cudasvc.com/url?a=https%3a%2f%2fpdsbiotech.us4.list-manage.com%2ftrack%2fclick%3fu%3d407bd594246e0ad6fd93882af%26id%3dcd47f52eaa%26e%3d27d88613f0&c=E,1,0DuzK2EulVf7Wkc70BYDbc0oUKE1z4uJlK5yyvn3kxOFbuQKCP_agnCM6IXQvqNvNt2eA3ulQunfXPtbiMs0zZ5nc3ckij1jjX4oIbv1mSruww,,&typo=1)
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(®) 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
(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 (mailto: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 (http://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(®), Versamune(®) plus PDS0301, and Infectimune™
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(®)
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(®) for the treatment of
recurrent/metastatic HPV16-positive head and neck cancer in 2023. Our
Infectimune™ 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
(https://linkprotect.cudasvc.com/url?a=https%3a%2f%2fpdsbiotech.us4.list-manage.com%2ftrack%2fclick%3fu%3d407bd594246e0ad6fd93882af%26id%3db073a8b05a%26e%3d27d88613f0&c=E,1,O5YnsW6MGKpFJrCP5eUPlWK0Y8pS4MyBJuNzRgngmlhU95MLeDTS7M4M9HBBY5OwxQUH0I8clB-1IE-vB6d0sgNrw8dOC1EuD20eNRst8w,,&typo=1)
or follow us on Twitter at @PDSBiotech.
This information is provided by RNS, the news service of the London Stock Exchange. RNS is approved by the Financial Conduct Authority to act as a Primary Information Provider in the United Kingdom. Terms and conditions relating to the use and distribution of this information may apply. For further information, please contact
rns@lseg.com (mailto:rns@lseg.com)
or visit
www.rns.com (http://www.rns.com/)
.
RNS may use your IP address to confirm compliance with the terms and conditions, to analyse how you engage with the information contained in this communication, and to share such analysis on an anonymised basis with others as part of our commercial services. For further information about how RNS and the London Stock Exchange use the personal data you provide us, please see our
Privacy Policy (https://www.lseg.com/privacy-and-cookie-policy)
. END UPDNKPBDQBKDKPD