Immediate release
NetScientific
plc
PDS Biotech Provides Business
Update and Reports Second Quarter 2024 Financial
Results
NetScientific Plc (AIM: NSCI), the
deep tech and life sciences VC investment group, reports that its
portfolio company, PDS Biotechnology Corporation (Nasdaq: PDSB), in
which it holds a 3% direct holding, has provided a business update
and reported financial results for the second quarter of
2024.
Frank Bedu-Addo, PhD, President and Chief Executive Officer of
PDS Biotech said:
"We are exiting the second quarter with momentum. We have
aligned with the FDA on the design of the Phase 3 registrational
trial of Versamune® HPV + pembrolizumab compared to pembrolizumab
as a potential treatment for first-line recurrent/metastatic
HPV16-positive head and neck squamous cell carcinoma
("HNSCC").
"This clinical trial is supported by the maturing data from
our VERSATILE-002 Phase 2 trial, including encouraging survival,
disease control response rates and safety data. We look forward to
the presentation of updated data from the VERSATILE-002 trial at
the European Society for Medical Oncology (ESMO) 2024 Congress in
September."
Kirk Shepard, MD, Chief Medical Officer,
stated:
"As a result of the recent VERSATILE-002 trial results, we
have revised the statistical endpoints of the VERSATILE-003 Phase 3
trial to provide additional robustness to our trial design. Our
goal now is to work with our clinical research organisation to
initiate the trial of the combination, which we believe has
potential as the first targeted immunotherapy for HPV16-positive
HNSCC. We anticipate that future studies of PDS01ADC have the
potential to provide additional clinical benefit to an effective
targeted immunotherapy."
Recent Developments
· Announced alignment with FDA to initiate Phase 3 VERSATILE-003
trial in HPV16-positive first-line recurrent or metastatic
HNSCC.
o This
trial will be designed to investigate the combination of
Versamune® HPV + pembrolizumab compared to
pembrolizumab, and this design reflects updated statistical
endpoints based on recent and more mature survival data from the
VERSATILE-002 trial.
o PDS
Biotech has initiated preparatory activities in connection with the
planned start of the Phase 3 VERSATILE-003 trial in Q4
2024.
· Abstract by Jared Weiss, M.D., UNC Lineberger Cancer Center
(Lead Investigator), presenting updated data from the VERSATILE-002
trial evaluating first-line treatment with Versamune®
HPV in combination with KEYTRUDA® (pembrolizumab) in
patients with HPV16-positive recurrent/metastatic HNSCC accepted
for presentation at the ESMO Congress 2024.
· Provided a survival data update from the ongoing VERSATILE-002
trial in HPV16-positive HNSCC based on data cut from May 17,
2024.
o Median overall survival is 30 months, consistent with data cut
as of November 30, 2023.
· Abstract by Adam Grippin, M.D., Ph.D., of the University of
Texas MD Anderson Cancer Center presenting updated results from the
IMMUNOCERV trial evaluating treatment of high-risk locally advanced
cervical cancer with Versamune® HPV in combination with
chemoradiotherapy accepted for oral presentation at the American
Society for Radiation Oncology (ASTRO) Annual Meeting
2024.
· Abstract by Renee Donahue, Ph.D., of the National Cancer
Institute presenting preliminary biomarker results from a Phase 2
trial evaluating treatment of biochemically recurrent prostate
cancer with PDS01ADC in combination with enzalutamide accepted for
oral presentation at the 12th Annual Meeting of the
International Cytokine and Interferon Society 2024.
Second Quarter 2024 Financial
Results
Reported net loss was approximately $8.3 million, or $0.23 per
basic share and diluted share, for the three months ended June 30,
2024, compared to a net loss of $11.5 million, or $0.37 per basic
share and diluted share, for the three months ended June 30, 2023.
The decrease was due to lower operating expenses.
Research and development expenses
decreased to approximately $4.5 million for the three months ended
June 30, 2024, from $8.0 million for the three months ended June
30, 2023. The decrease of $3.5 million was primarily attributable
to lower clinical trial and manufacturing costs.
General and administrative expenses
decreased to approximately $4.2 million for the three months ended
June 30, 2024, from approximately $4.7 million for the three months
ended June 30, 2023. The decrease of $0.5 million was primarily
attributable to lower personnel costs and professional
fees.
Total operating expenses decreased
to approximately $8.7 million for the three months ended June 30,
2024, from $12.7 million for the three months ended June 30,
2023.
Net interest expenses increased to
approximately $0.5 million for the three months ended June 30,
2024, from $0.2 million for the three months ended June 30,
2023.
Cash and cash equivalents as of June
30, 2024, totalled approximately $57.7 million.
A
full version of PDS Biotech's announcement can be accessed
here:
https://pdsbiotech.com/index.php/investors/news-center/press-releases/press-releases1/131-2024-news/933-iotechlignswithonhase3rialin16osit20240801
-Ends-
For more information, please
contact:
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NetScientific
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Ilian Iliev, CEO
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Via Belvedere
Communications
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Panmure Liberum Limited (NOMAD and Broker)
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Emma Earl / Will Goode / Freddy
Crossley / Mark Rogers (Corporate Finance)
Rupert Dearden (Corporate
Broking)
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+44 (0)20 7886 2500
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Belvedere Communications
John West / Llewellyn Angus / Lily
Pearce
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+44 (0)20 7653 8702
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About NetScientific
NetScientific plc (AIM: NSCI) is a
deep tech and life sciences VC investment group with an
international portfolio of innovative 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-efficient 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 Biotechnology is a
late-stage immunotherapy company focused on transforming how the
immune system targets and kills cancers and the development of
infectious disease vaccines. The Company plans to initiate a
pivotal clinical trial in 2024 to advance its lead program in
advanced HPV16-positive head and neck squamous cell cancers. PDS
Biotech's lead investigational targeted immunotherapy Versamune®
HPV is being developed in combination with a standard-of-care
immune checkpoint inhibitor, and also in a triple combination
including PDS01ADC, an IL-12 fused antibody drug conjugate (ADC),
and a standard-of-care immune checkpoint inhibitor.
www.pdsbiotech.com.