REG - EMV Capital PLC - PDS: Clinical Programs Update, 3rd Quarter Results

EMV CapitalAnnouncement

14/11/2024 15:30

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RNS Number : 3176M  EMV Capital PLC  14 November 2024

For immediate release

 

EMV Capital plc

 

("EMVC" or the "Company")

 

PDS Biotech Provides Clinical Programs Update and Reports Third Quarter 2024
Financial Results

 

EMV Capital plc (AIM: EMVC), the deeptech and life sciences VC investment
group, reports that its portfolio company PDS Biotechnology Corporation
(Nasdaq: PDSB) in which it holds a 2.5% direct holding has provided a business
update and reported financial results for the third 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.

 

Dr Frank Bedu-Addo, Ph.D., President and Chief Executive Officer of PDS
Biotech said:

 

"Since our last update in August, we have been actively engaged with investors
and clinicians to discuss our strategy and funding requirements for our
VERSATILE-003 Phase 3 trial of Versamune(®) HPV + pembrolizumab compared to
pembrolizumab as a potential treatment for first-line recurrent/metastatic
HPV16-positive head and neck squamous cell cancer (HNSCC).  Based on investor
feedback, discussions with key opinion leaders involved with the study and
other experts, we have made minor modifications to the VERSATILE-003 trial
design to reduce the overall cost and time required to achieve an interim data
readout and trial completion."

 

With submission of the updated Investigational New Drug (IND) application to
the U.S. Food and Drug Administration (FDA) this week, PDS Biotech expects the
FDA clearance decision by mid-December, allowing PDS Biotech to initiate site
activation in the first quarter of 2025.

 

Dr Bedu-Addo concluded:

 

"Elsewhere in our pipeline, we were pleased with the data from the IMMUNOCERV
Phase 2 clinical trial evaluating Versamune(®) HPV with chemoradiation to
treat locally advanced cervical cancer presented at the American Society for
Radiation Oncology (ASTRO) annual meeting. The presented data demonstrated
promising clinical activity and a compelling safety profile. Based on
continued research in various HPV-positive cancers conducted by PDS Biotech
and independent researchers who recognize its potential, Versamune(®) HPV
appears to work in combination with a variety of therapeutic agents to
generate clinical responses and promote improved survival in patients with
favourable toxicity. We are exploring the next steps in the development of
Versamune(®) HPV for cervical cancer."

 

Recent Developments

·  Update to Phase 3 VERSATILE-003 Trial Design in HPV16-positive
first-line recurrent and/or metastatic HNSCC

·      Updated trial design to include approximately 350 patients

·  VERSATILE-002 results have shown broadly improving clinical responses
across multiple parameters with increases in patient size and duration of
patient follow up over the last year, demonstrating durability of the
anti-tumour responses

·     The design, which is informed by the observed durability of the
clinical responses, retains           statistical power and remains
within the confines of PDS Biotech's agreement with the FDA on
 registrational design

·      Design maintains 2:1 randomization and median overall survival as
primary endpoint

·      Design imparts potential for earlier interim readouts and study
completion

·      Design presents potential for reduced execution costs

·      Amended IND (updated design) submitted November 2024

·      In September 2024,PDS Biotech provided updated results from the
PDS Biotech VERSATILE-002 Phase 2 clinical trial in recurrent and/or
metastatic HPV16-positive HNSCC patients treated with the combination of
Versamune(®) HPV and pembrolizumab presented at European Society for Medical
Oncology (ESMO) Congress 2024 by Jared Weiss, M.D., Section Chief of Thoracic
and Head/Neck Oncology, Professor of Medicine at the University of North
Carolina, and principal investigator of the VERSATILE-002 clinical trial.

·     In October 2024, PDS Biotech provided updated results from the PDS
Biotech IMMUNOCERV Phase 2 clinical trial in locally advanced cervical cancer
patients treated with Versamune(®) HPV and chemoradiotherapy presented at the
ASTRO Annual Meeting by Adam Grippin, M.D., Ph.D., The University of Texas MD
Anderson Cancer Center.

·   Ravi A. Madan, M.D., Head, Prostate Cancer Clinical Research Section,
Genitourinary Malignancies Branch, Center for Cancer Research, National Cancer
Institute, part of the U.S. National Institutes of Health presented the
rationale and design of recurrent prostate cancer trial combining Xtandi(®) +
PDS01ADC vs Xtandi(®) alone during an oral presentation at the 12(th) Annual
Meeting of the International Cytokine and Interferon Society, October 2024.

Third Quarter 2024 Financial Results

Reported net loss was approximately $10.7 million, or $0.29 per basic share
and diluted share, for the three months ended September 30, 2024, compared to
a net loss of $10.8 million, or $0.35 per basic share and diluted share, for
the three months ended September 30, 2023. The decrease was primarily due to
lower operating expenses.

Research and development expenses increased to approximately $6.8 million for
the three months ended September 30, 2024, from $6.4 million for the three
months ended September 30, 2023. The increase of $0.4 million was primarily
attributable to higher manufacturing expenses, partially offset by lower
clinical costs and personnel expenses.

General and administrative expenses decreased to approximately $3.4 million
for the three months ended September 30, 2024, from approximately $4.1 million
for the three months ended September 30, 2023. The decrease of $0.7 million
was primarily attributable to lower personnel costs and professional fees.

Total operating expenses decreased to approximately $10.2 million for the
three months ended September 30, 2024, from $10.5 million for the three months
ended September 30, 2023.

Net interest expenses increased to approximately $0.5 million for the three
months ended September 30, 2024, from $0.3 million for the three months ended
September 30, 2023.

Cash and cash equivalents as of September 30, 2024 totalled approximately
$49.8 million.

A full version of PDS Biotech's announcement, including the Condensed
Consolidated Statements of Operations and Comprehensive Loss and Selected
Balance Sheet Data, can be accessed here:

 

https://pdsbiotech.com/index.php/investors/news-center/press-releases/press-releases1/131-2024-news/957-iotechrovideslinicalrogramspdateandeports20241114
(https://pdsbiotech.com/index.php/investors/news-center/press-releases/press-releases1/131-2024-news/957-iotechrovideslinicalrogramspdateandeports20241114)
(https://www.pdsbiotech.com/index.php/investors/news-center/press-releases/press-releases1/125-2023-news/889-iotechnologyeportsnducementrantnderasdaqis20231204)

 

-Ends-

 

For more information, please contact:

 EMV Capital plc                                                             via Rosewood
 Ilian Iliev, CEO

 Panmure Liberum (UK) Limited (NOMAD and Broker)                             +44 (0)20 7886 2500
 Emma Earl / Will Goode / Freddy Crossley / Mark Rogers (Corporate Finance)
 Rupert Dearden (Corporate Broking)

 Rosewood (Financial PR)                                                     +44 (0)20 7653 8702
 John West / Llew Angus / Lily Pearce

 

 

About EMV Capital plc (EMVC)

 

EMV Capital plc, formerly known as NetScientific plc, is a deep tech and life
sciences venture capital investment group with an international portfolio of
high-growth companies.

With a strategic focus on generating superior returns for investors from the
fast-growing sectors and technologies that will define our future; EMV Capital
invests in, manages and strengthens early stage IP-rich companies.

EMV Capital holds both direct equity stakes and carried interest in its
portfolio companies, creating an evergreen structure that supports extensive
growth and value creation. EMV Capital's investment thesis is realised through
these capital sources:

·    capital-efficient investments through Group balance sheet;

·    fund management of the Evergreen EIS and Martlet Capital Funds;

·    syndicated investments leveraging its network of third-party
investors.

EMV Capital's approach is characterised by its proactive management style,
aiming to advance portfolio companies to critical value inflection points by
actively engaging with them. Companies are supported through Board
representation and the use of its Value Creation Services practice.

Headquartered in London, with a Cambridge presence and strong international
links, EMV Capital is quoted on the AIM market of the London Stock Exchange.

www.emvcapital.com (http://www.emvcapital.com/)

 

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 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 (http://www.pdsbiotech.com)

 

 

 

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