REG - NetScientific PLC - PDS Strategy Update and 2023 Financial Results

NetscientificAnnouncement

27/03/2024 13:45

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RNS Number : 5583I  NetScientific PLC  27 March 2024

For immediate release

 

NetScientific plc

 

Portfolio company PDS Biotech Announces Clinical Strategy Update and Reports
Full Year 2023 Financial Results

 

·     Unique mechanism of action of the combination of PDS01ADC and
Versamune® results in 3-year survival of 75% and 75% overall response rate in
advanced head and neck cancer trial

·     As a result, Company to focus late-stage clinical strategy on
triple combination of PDS01ADC, PDS0101 (Versamune® HPV) and KEYTRUDA® in
advanced head and neck cancer

·     Strong safety profile of IL-12 fused antibody drug conjugate
(PDS01ADC) demonstrated to date with data generated in >300 cancer
patients; Versamune® HPV tested in >110 HNSCC patients

·     Successful recent meeting with FDA provided clear guidance on trial
design and regulatory pathway for pivotal randomised trial of triple
combination in recurrent metastatic HPV-positive HNSCC

 

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, a late-stage
immunotherapy company focused on transforming how the immune system targets
and kills cancers and the development of infectious disease vaccines, today
announced an update to its clinical development strategy and reported its
financial results for the year ended December 31, 2023. Extracts of the
announcement are below.

 

Frank Bedu-Addo, PhD, Chief Executive Officer of PDS Biotech said:

 

"We have obtained compelling data from several Phase 2 trials in the fourth
quarter of 2023, including long-term survival data from the National Cancer
Institute (NCI)-led triple combination trial of PDS01ADC in combination with
Versamune® HPV (PDS0101) and an investigational immune checkpoint inhibitor
(ICI), as well as our VERSATILE-002 study. We now have a better understanding
of how our drug platform technology works in advanced cancer, and we have
therefore made the strategic, data-driven decision to add our novel,
investigational IL-12 fused antibody drug conjugate, PDS01ADC, to the
promising combination of Versamune® HPV and KEYTRUDA® to advance the triple
combination as our top clinical development priority."

 

He continued:

 

"By initially addressing the rapidly growing unmet medical need in recurrent
metastatic HPV+ head and neck squamous cell cancer (HNSCC), we strongly
believe this approach may rapidly establish our proprietary combination of
PDS01ADC and Versamune® HPV as a transformative oncology treatment. The data
suggest that the triple combination may result in a significant improvement in
overall survival rates for patients who currently lack an effective treatment
option. It may also significantly increase the rates of durable tumour
shrinkage or overall responses. We are grateful to the patients and physicians
who participated in the clinical trials which have helped inform our
understanding of how the drug therapies may be used most effectively to safely
address advanced cancer, and our decision to prioritise the triple
combination."

 

With the recent long-term survival Phase 2 data from the NCI-led triple
combination trial, together with favourable safety and extended survival
results seen in both ICI naïve and resistant patients in our VERSATILE-002
trial, PDS Biotech has decided to prioritise the triple combination in place
of the VERSATILE-003 trial. This decision enables PDS Biotech to focus its
resources on the drug regimen it believes has the highest potential to benefit
patients with HNSCC and to drive shareholder value.

 

Kirk V. Shepard, M.D., Chief Medical Officer of PDS Biotech said:

"We have had several discussions with key opinion leaders in HNSCC regarding
the use of the triple combination in HNSCC. A clear unmet need is seen in HPV+
HNSCC with few agents being studied in this population due to the difficulty
in treating advanced HNSCC. These discussions with expert HNSCC oncologists
have guided our decision to prioritise the triple combination in our efforts
to address the growing incidence of advanced HPV+ HNSCC."

 

Katharine A. Price, M.D., Associate Professor of Oncology, Head and Neck
Disease Group, Mayo Clinic Comprehensive Cancer Centre, and Principal
Investigator of PDS Biotech's upcoming triple combination trial added:

 

"Despite good outcomes in many patients with HPV-related HNSCC, approximately
20% of patients will develop recurrent, incurable disease, often in young
individuals in the prime of their lives. HPV-related HNSCC that progresses
after standard first-line chemotherapy is a devastating, hard-to-treat cancer
with no HPV-related treatment currently approved. The NCI clinical trial data
show significant promise in the use of PDS01ADC in combination with
Versamune® HPV. A controlled randomised clinical trial that builds upon the
current data is warranted, and I am intrigued by the potential of this unique
combination to treat HNSCC."

 

Clinical Strategy Update:

Triple Combination Clinical Trial (PDS01ADC, Versamune® HPV and KEYTRUDA®)

 

·      Company in discussions with the U.S. Food and Drug Administration
(FDA) on the design of potentially pivotal clinical trial to treat HPV+ HNSCC,
with the trial expected to start in 2024.

·      Previously announced data from Phase 2 NCI-led triple combination
clinical trial for the treatment of recurrent/metastatic ICI naïve and ICI
resistant HPV16-positive cancers including head and neck, anal, cervical,
vaginal, and vulvar cancers support rationale:

o  ICI naïve group:

·      75% of patients remain alive at 36 months. The median overall
survival (OS) was not reached. Published results show a 36-month survival rate
of approximately 20% with ICIs. An overall response rate (ORR) of 75% and
complete response of 38% were seen in patients treated with the triple
combination. Published ORR of <40% seen with immunotherapeutic agents.

o  ICI resistant group:

·      12-month OS rate of 72%, and 63% ORR in patients with optimal
dose of PDS01ADC. Median OS approximately 20 months; published 12-month OS
rate in HPV-positive ICI-resistant cancer is ~30%; published median OS in
HPV-positive ICI-resistant cancer is 3.4 months.

o  Responses were seen in all HPV-positive tumour types.

 

Leadership Appointments

 

·      In January 2024, announced the appointment of Dr. Shepard as
Chief Medical Officer.

·      In November 2023, announced the appointment of Lars Boesgaard as
Chief Financial Officer.

 

Full Year 2023 Financial Results

 

Net loss for the year ended December 31, 2023, was approximately $42.9
million, or $1.39 per basic and diluted share, compared to a net loss of $40.9
million, or $1.43 per basic share and diluted share, for the year ended
December 31, 2022. The higher net loss was primarily the result of increased
operating loss and increased net interest expense.

 

Research and development expenses for the year ended December 31, 2023,
decreased to $27.8 million, compared to $29.4 million for the year ended
December 31, 2022. The decrease of $1.7 million was primarily attributable to
the $10 million purchase of the rights to PDS01ADC in 2022, partially offset
by an increase in clinical costs of $6.1 million and an increase in personnel
costs of $2.1 million.

 

General and administrative expenses for the year ended December 31, 2023,
increased to $15.3 million compared to $12.2 million for the year ended
December 31, 2022. The $3.1 million increase was primarily attributable to an
increase in personnel costs of $1.5 million and an increase in professional
fees of $1.6 million.

 

Total operating expenses for the year ended December 31, 2023, were $43.0
million, an increase of approximately 3.3% compared to $41.7 million total
operating expenses for the year ended December 31, 2022.

 

Net interest expense increased to $1.3 million for the year ended December 31,
2023, compared to $0.4 million for the year ended December 31, 2022. The
change was due to higher interest expense related to the Company's notes
payable, partially offset by higher interest income on bank deposits.

 

During the fourth quarter of 2023, the Company raised approximately $10.5
million in net proceeds from its "at-the-market" sales agreement.

 

The Company's cash balance as of December 31, 2023, was $56.6 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/902-iotechnnounceslinicaltrategypdateandeports20240327
(https://pdsbiotech.com/index.php/investors/news-center/press-releases/press-releases1/131-2024-news/902-iotechnnounceslinicaltrategypdateandeports20240327)

 

-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 antibody drug conjugate (ADC) PDS01ADC
and T-cell activator Versamune® HPV in regimen with a standard-of-care immune
checkpoint inhibitor. Proof-of-concept long-term data have shown positive
survival results and tumor shrinkage with this combination and indicate
favorable tolerability.

 

With a novel investigational "inside-out" mechanism, the dual immunotherapy
has shown compelling results with potential to successfully disrupt a tumor's
inside defenses, while also generating potent, targeted killer T-cells to
attack the tumor from the outside. Robust data from more than 350 patients, as
well as ongoing clinical trials across multiple tumor types and standard
treatment regimens, have validated the platforms and point to potential broad
utility.

 

Our Infectimune® based vaccines have 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.

 

www.pdsbiotech.com
(https://pdsbiotech.us4.list-manage.com/track/click?u=407bd594246e0ad6fd93882af&id=7407d497e9&e=735607fbc5)

 

 

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