For immediate release
NetScientific
plc
PDS Biotech Provides Business
Update and Reports First Quarter 2024 Financial
Results
Provided Positive, Updated
Data from Phase 2 VERSATILE-002 Clinical Trial with Versamune® HPV
in Combination with KEYTRUDA® in Recurrent or Metastatic Head and
Neck Cancer
Expanded Global Intellectual
Property Surrounding Versamune® Platform
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 3.5% direct holding, today provided a business
update, and reported financial results for the first quarter of
2024. PDS Biotech 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 press release
will be available on the Investor Relations section of the
Company's website at
www.pdsbiotech.com
Recent Developments
· Hosted
a Key Opinion Leader event on May 8, 2024, during which prominent
experts in head and neck squamous cell cancer ("HNSCC") discussed
positive, updated VERSATILE-002 data and the unmet need in
HPV16-positive HNSCC. A replay of the event can be found
here.
· Announced updated results from the VERSATILE-002 Phase 2 trial
evaluating first line treatment of patients with HPV16-positive
recurrent or metastatic HNSCC using Versamune® HPV +
KEYTRUDA® (pembrolizumab) (n=53).
o Median overall survival is 30 months; Published results
for immune checkpoint inhibitors are 7-18 months.
o The
cohort met its primary endpoint of best overall response
(BOR).
o BOR
by investigator assessment is 34% (Combined Positive Score (CPS)
≥1; n=18/53); 48% (CPS≥20; n=10/21); Published results for ICIs are
<20% (CPS>1) and <25%
(CPS≥20).
§ CPS is
used to assess PD-L1 expression
o Progression free survival is 6.3 months (CPS≥1); 14.1 months
(CPS≥20); Published results for immune checkpoint inhibitors 2-3
months.
o VERSATILE-002 data to date indicate a durable response in
first line recurrent or metastatic HNSCC patients with
CPS≥1.
o The
combination of Versamune® HPV + pembrolizumab was well
tolerated.
· Announced an updated clinical strategy with a two-part
registrational trial focused on the triple combination of
Versamune® HPV + PDS01ADC + pembrolizumab as a first
line treatment in HPV16-positive recurrent or metastatic
HNSCC.
o PDS01ADC is the Company's novel, investigational
tumour-targeting IL-12-fused antibody-drug conjugate (ADC), which
has shown promise in a clinical trial of Versamune® HPV
+ PDS01ADC + an investigational ICI conducted by the National
Cancer Institute.
o Part
one of the clinical trial will focus on dose optimisation with a
data readout based on safety and objective response
rate.
o The
randomised second part of the trial will include an interim data
readout with overall survival as its primary
endpoint.
· Further strengthened management with the addition of Stephan
Toutain, M.S., MBA, as Chief Operating Officer. Mr. Toutain brings
extensive operational and commercial experience to PDS
Biotech.
Versamune® Platform Intellectual
Property
· Company received patents granted by the Israel Patent Office
and IP Australia that will extend protections for the Company's
novel investigational T cell activating Versamune® platform through
Dec. 2038 and Nov. 2036, respectively.
o The
Israel Patent Office granted patent No. 275154 titled, "Methods and
compositions comprising cationic lipids for stimulating type I
interferon genes," extending protections for compositions using the
Versamune® platform and comprising of cationic lipid for activating
type I interferons. This patent covers all formulations and
compositions that include Versamune to activate a T cell
response.
o IP
Australia granted patent No. 2016354590 titled, "Lipids as
synthetic vectors to enhance antigen processing and presentation
ex-vivo in dendritic cell therapy." This patent covers the use of
Versamune® compositions that reduce the populations of immune
suppressive cells in the tumour and its application for the
development of dendritic cell-based approaches to
immunotherapy.
First Quarter 2024 Financial Results
Reported net loss was
approximately $10.6 million, or $0.30 per basic share and diluted
share, for the three months ended March 31, 2024, compared to a net
loss of $9.7 million, or $0.32 per basic share and diluted share,
for the three months ended March 31, 2023. The increase was due to
higher operating and net interest expenses.
Research and development expenses
increased to approximately $6.7 million for the three months ended
March 31, 2024, from $5.8 million for the three months ended March
31, 2023. The increase of $0.9 million was primarily attributable
to an increase of $1.2 million in clinical studies and medical
affairs offset by a decrease of $0.1 million in personnel costs,
$0.1 million in professional fees and $0.1 million in manufacturing
expenses.
General and administrative expenses
decreased to approximately $3.4 million for the three months ended
March 31, 2024, from approximately $3.6 million for the three
months ended March 31, 2023. The decrease of $0.2 million was
primarily attributable to an increase of $0.3 million in
professional fees offset by a decrease of $0.5 million in personnel
costs.
Total operating expenses increased
to approximately $10.1 million for the three months ended March 31,
2024 from $9.4 million for the three months ended March 31,
2023.
Net interest expenses increased to
approximately $0.5 million for the three months ended March 31,
2024 from $0.2 million for the three months ended March 31,
2023.
Cash and cash equivalents as of
March 31, 2024, totaled approximately $66.6 million.
A
full version of PDS Biotech's announcement can be accessed
here:
https://www.pdsbiotech.com/index.php/investors/news-center/press-releases/press-releases1/131-2024-news/925-iotechrovidesusinesspdateandeportsirstuar20240515
-Ends-
For more information, please
contact:
NetScientific
|
|
Ilian Iliev, CEO
|
Via Belvedere
Communications
|
|
|
Panmure Gordon (UK) Limited (NOMAD and
Broker)
|
|
Emma Earl / Freddy Crossley / Will
Goode / Mark Rogers (Corporate Finance)
Rupert Dearden (Corporate
Broking)
|
+44 (0)20 7886 2500
|
|
|
Belvedere Communications
John West / Llew 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
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 head and neck squamous cell cancers (HNSCC). PDS Biotech's
lead program is a proprietary dual-acting combination of IL-12
fused antibody drug conjugate (ADC) PDS01ADC and T-cell activator
Versamune® HPV in regimen with a standard-of-care
immune checkpoint inhibitor. We believe that proof-of-concept
long-term data have shown positive survival results and tumour
shrinkage with this combination and indicate favourable
tolerability.
We believe that with a novel
investigational "inside-outside" mechanism, the PDS01ADC and
Versamune® HPV immunotherapy has shown compelling
results with potential to successfully disrupt a tumour inside
defences, while also generating potent, targeted killer T-cells to
attack the tumour from the outside. We believe that data from more
than 350 patients, as well as ongoing clinical trials across
multiple tumour types and standard treatment regimens, have
validated the potential for both platforms and point to potential
broad utility.
Our
Infectimune® based vaccines have demonstrated the
potential to induce not only robust and durable neutralising
antibody responses, but also powerful T-cell responses, including
long-lasting memory T-cell responses in pre-clinical studies to
date. For more information, please
visit www.pdsbiotech.com.