TIDMNSCI
RNS Number : 2823J
NetScientific PLC
14 August 2023
RNS: For immediate release
NetScientific plc
PDS Biotechnology Reports Second Quarter 2023 Financial Results
and Provides Business Update
Successful submission of final clinical protocol and supporting
CMC information to FDA to initiate Phase 3 VERSATILE-003 trial in
the fourth quarter 2023
Biomarker data from VERSATILE-002 to be presented at ESMO
2023
NetScientific Plc (AIM: NSCI), the deep tech and life sciences
VC investment group, reports that its portfolio company, PDS
Biotechnology Corporation (Nasdaq: PDSB), a clinical-stage
immunotherapy company developing a growing pipeline of targeted
cancer immunotherapies and infectious disease vaccines based on its
proprietary T cell activating platforms, has released its financial
results for the quarter ended 30 June 2023 and has provided a
business update .
Recent Business Highlights:
PDS0101 Lead Drug Candidate
-- VERSATILE-003: Submitted the final Phase 3 clinical protocol
and supporting Chemistry, Manufacturing and Controls (CMC)
information to the U.S. Food and Drug Administration (FDA) to
enable initiation of the VERSATILE-003 randomized, controlled
multicenter study of PDS0101 in combination with Merck's anti-PD-1
therapy, KEYTRUDA(R) (pembrolizumab) in patients with human
papillomavirus (HPV) 16-positive recurrent and/or metastatic head
and neck cancer in the fourth quarter 2023
-- VERSATILE-002: Phase 2 open-label, multicenter study of
PDS0101 in combination with KEYTRUDA(R) in patients with human
papillomavirus (HPV) 16-positive recurrent and/or metastatic head
and neck cancer
o Announced clinical immune response data to be presented at
upcoming European Society for Medical Oncology (ESMO) Congress
2023
-- Biomarker data highlighting HPV16-specific killer and helper
T cell responses will be presented
o Presented interim data at the 2023 American Society of
Clinical Oncology (ASCO) annual meeting, demonstrating a 12-month
overall survival rate of 87%, with only 8% of patients experiencing
Grade 3 treatment-related adverse events, and no reports of more
severe Grade 4 or 5 adverse events
o Achieved the efficacy threshold in Stage 2 of this clinical
trial for the naïve patient arm
-- 14 patients in the immune checkpoint inhibitor (ICI) naïve
arm experienced either a complete response or partial response on
two consecutive scans 9-12 weeks apart, constituting a confirmed
objective response. This result suggests that PDS0101 has a
statistically significant additive effect over published results of
ICI monotherapy
o Completed enrollment in the ICI naïve arm and expect final
data readout in mid-2024
PDS0301 Antibody-Conjugated Interleukin 12 (IL-12)
-- PDS0301 + docetaxel: Phase 2, open label, single-arm trial of
PDS0301 in combination with docetaxel in metastatic castration
sensitive and castration resistant prostate cancer, led by the
National Cancer Institute (NCI)
o Announced selection of abstract for oral presentation by the
NCI at the upcoming Cytokines 2023 Annual Meeting on 15-1 8October
2023
o The Phase 2 clinical trial is investigating the safety, immune
responses, and clinical activity of the combination in metastatic
prostate cancer patients
o First clinical trial of an immunocytokine with docetaxel in
prostate cancer patients
Business Highlights
-- PDS Biotech was added to the broad-market Russell 2000(R) and
Russell 3000(R) Indexes in June 2023
Dr Frank Bedu-Addo, CEO of PDS Biotech, stated:
"We continue to make significant strides with our lead
candidate, PDS0101, specifically with the regulatory and clinical
activities necessary to initiate the VERSATILE-003 trial, as well
as with progression of the Phase 2 VERSATILE-002 clinical trial. In
the second quarter, at ASCO 2023, we presented interim data from
VERSATILE-002 which revealed an impressive estimated 12-month
overall survival rate of 87% and a progression-free survival of
10.4 months, while maintaining a favorable safety profile when
PDS0101 is combined with KEYTRUDA(R) . The reported 12-month
overall survival rate for immune checkpoint inhibitors is 30-50%.
These encouraging findings fuel our enthusiasm as we prepare to
initiate the Phase 3 VERSATILE-003 clinical trial in which patient
overall survival will be the primary trial outcome in the fourth
quarter of 2023.
"In addition to our enthusiasm for PDS0101, we are thrilled
about the prospects of PDS0301 which we believe may potentially
overcome some of the key safety and efficacy limitations of current
cytokines. We are excited about the NCI's abstract acceptance at
the upcoming Cytokines 2023 annual meeting. We anticipate these
results have the potential to offer valuable insights into the use
of PDS0301 in conjunction with chemotherapy for various solid
tumors, presenting a promising avenue for future development and
commercialization possibilities."
Dr Ilian Iliev, CEO of NetScientific, added:
"We are pleased to see the continued progress made by Frank and
his team during the quarter, including with its lead candidate,
PDS0101."
Second Quarter 2023 Financial Results
Net loss for the three months ended 30 June 2023 was
approximately $11.5 million, or ($0.37) per basic share and diluted
share, compared to a net loss of approximately $5.8 million, or
($0.20) per basic share and diluted share, for the three months
ended 30 June 30 2022. The higher net loss this quarter was
primarily due to costs incurred in connection with our research and
development programs.
Research and development expenses increased to $8.0 million for
the three months ended 30 June 2023 from $3.8 million for the three
months ended 30 June 2022. The increase of $4.2 million is
primarily attributable to an increase of $1.4 million in clinical
trials, $0.5 million in personnel costs, including $0.2 million in
non-cash stock-based compensation, and $2.3 million in
manufacturing expenses.
General and administrative expenses increased to $4.7 million
for the three months ended 30 June 2023 from $3.3 million for the
three months ended 30 June 2022. The increase of $1.4 million is
primarily attributable to an increase of $0.5 million in personnel
costs, including $0.4 million in non-cash stock-based compensation
and $0.9 million in professional fees.
Cash and cash equivalents as of 30 June 2023, totaled
approximately $60.6 million. Based on the Company's cash resources,
PDS Biotech believes this amount is sufficient to fund operations
and research and development programs for 12 months following the
filing of the Company's June 2023 Quarterly Report on Form 10-Q
which will be filed as of the date of this press release.
A full version of PDS Biotech's announcement with more detailed
financial information can be accessed here:
https://www.pdsbiotech.com/index.php/investors/news-center/press-releases/press-releases1/125-2023-news/855-iotecheportseconduarter2023inancialesultsa20230814
-Ends-
For more information, please contact:
NetScientific
Ilian Iliev, CEO Via Belvedere Communications
WH Ireland (NOMAD, Financial Adviser and Broker)
Chris Fielding / Darshan Patel +44 (0)20 7220 1666
Belvedere Communications
John West / Llew Angus +44 (0) 203 008 6867
Email: nsci@belvederepr.com
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-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
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(R) ,
Versamune(R) plus PDS0301, and Infectimune(R) T cell-activating
platforms. 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(R) clinical
candidate, PDS0101, has demonstrated the ability to reduce and
shrink tumours 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(R) for the treatment of recurrent/metastatic
HPV16-positive head and neck cancer in 2023. Our Infectimune(R)
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 or follow us on Twitter at
@PDSBiotech.
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