PDS Biotech: Business Update and Q2 2024 Results
13/08/2024 15:57
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RNS Number : 3106A NetScientific PLC 13 August 2024
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 12(th)
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
(https://pdsbiotech.com/index.php/investors/news-center/press-releases/press-releases1/131-2024-news/933-iotechlignswithonhase3rialin16osit20240801)
-Ends-
For more information, please contact:
NetScientific
Ilian Iliev, CEO Via Belvedere Communications
Panmure Liberum Limited (NOMAD and Broker)
Emma Earl / Will Goode / Freddy Crossley / Mark Rogers (Corporate Finance) +44 (0)20 7886 2500
Rupert Dearden (Corporate Broking)
Belvedere Communications
John West / Llewellyn Angus / Lily Pearce +44 (0)20 7653 8702
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 (http://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
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.
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