PDS Biotech: Business Update and Q1 2024 Results
15/05/2024 14:32
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RNS Number : 5925O NetScientific PLC 15 May 2024
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
(https://linkprotect.cudasvc.com/url?a=https%3a%2f%2fwww.pdsbiotech.com&c=E,1,QlUNZZGfObh00vhnfHpN1Iso9oH8PIv8QoPzM9riZU4IJGtjkBD-jpMY5a3ZhAO0NI2OqHJk9O1bxpFMKIfkkf_HjXCO5qS8pTf_63tuYKJwrafA&typo=1&ancr_add=1)
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
(https://linkprotect.cudasvc.com/url?a=https%3a%2f%2fpdsbiotech.us4.list-manage.com%2ftrack%2fclick%3fu%3d407bd594246e0ad6fd93882af%26id%3dceece31c4c%26e%3d27d88613f0&c=E,1,BrbbcSCgqd4pzrq-G3yoWGTdTHYfToEFc6AnD0NmqRWIJsCWiT4_Sca4UXXHvU7TTUWw_7dD93TRzsLkZzmjbSc3ONSy-cDO-zHnGMA8QdpG9dE99OhDv9A,&typo=1)
.
· 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
(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) +44 (0)20 7886 2500
Rupert Dearden (Corporate Broking)
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 (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 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
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