REG - NetScientific PLC - PDS BioTechnology: Third Quarter Results

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14/11/2023 16:45

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RNS Number : 4436T  NetScientific PLC  14 November 2023

RNS: For immediate release

 

NetScientific plc

 

PDS Biotech Reports Third Quarter 2023 Financial Results and Provides Business
Update

 

•             Announced 75% of ICI-naive patients alive at 36
months in the NCI-led triple Phase 2 combination trial for advanced
HPV16-positive cancer patients; published median overall survival of 7-11
months with FDA approved ICI1

•             Announced 2-year overall survival rate of 74% in
VERSATILE-002 Phase 2 trial of ICI-naïve HPV16-positive recurrent or
metastatic head and neck cancer patients; published 2-year overall survival of
less than 30% with FDA approved ICI1

•             Announced interim safety and immune response data
for Phase 1/2 clinical trial evaluating docetaxel and PDS01ADC in metastatic
prostate cancer patients; PSA decline was seen in all 18 patients and 61% of
patients had at least a 60% decrease in PSA levels

•             Company to host conference call and webcast today
at 8:00 AM EST

 

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 the company's proprietary T cell activating platforms, has
announced its financial results for the quarter ended September 30, 2023.

 

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

 

"We are pleased with the outcome of the National Cancer Institute (NCI)-led
Phase 2 triple combination trial of PDS0101, PDS01ADC (formerly known as
PDS0301) and an investigational immune checkpoint inhibitor (ICI). The data
show that 75% of immune checkpoint inhibitor (ICI)-naïve patients remain
alive at three years, and the 12-month overall survival (OS) rate in the
ICI-resistant patients is 72. Furthermore, the triple combination continues to
be well tolerated, with only 4% of patients reported to have Grade 4
treatment-related adverse events."

 

He continued:

 

"As the development of our IL12 fused antibody-drug conjugate or ADC,
PDS01ADC, continues to progress, its potential to overcome key safety and
efficacy limitations associated with existing cytokine therapy is reinforced.
Data presented at Cytokines 2023 marked the first-in-human clinical trial
evaluating the combination of docetaxel chemotherapy and PDS01ADC to treat
advanced metastatic castration sensitive (mCSPC) and castration resistant
prostate cancer (mCRPC). Decreases in prostate-specific antigen (PSA) levels
were reported in all patients. In addition, with our lead candidate PDS0101,
the interim Phase 2 VERSATILE-002 data presented during our Key Opinion Leader
(KOL) roundtable showed a 2-year overall survival rate of 74% in ICI-naïve
human papillomavirus (HPV)16- recurrent/metastatic head and neck cancer
patients. We are excited about the strides we are making across our pipeline,
fuelled by our commitment to developing groundbreaking therapies that
revolutionize cancer treatments."

 

Recent Business Highlights:

PDS0101 Lead Drug Candidate

 

·    VERSATILE-003: Received feedback from the U.S. Food and Drug
Administration (FDA) regarding the Phase 3 clinical protocol for a randomized,
controlled multicentre trial of PDS0101 in combination with Merck's anti-PD-1
therapy, KEYTRUDA(®) (pembrolizumab) in patients with HPV16-positive
recurrent and/or metastatic head and neck cancer. PDS Biotech anticipates
initiation of VERSATILE-003 in Q1 2024.

·    VERSATILE-002: Phase 2 open-label, multicentre clinical trial of
PDS0101 in combination with KEYTRUDA(®) in patients with HPV16-positive
recurrent and/or metastatic head and neck cancer.

o  Hosted KOL roundtable on interim VERSATILE-002 data
(https://linkprotect.cudasvc.com/url?a=https%3a%2f%2fpdsbiotech.us4.list-manage.com%2ftrack%2fclick%3fu%3d407bd594246e0ad6fd93882af%26id%3de5becacb6b%26e%3d27d88613f0&c=E,1,6r4hz3z67sT-Nl4LaCrUqEuBhOeyAf9AoIrIaqFSycGCJH9Z5MXf63PV3BsJs4MBBYbHkrmW30OfQn-QCjAgudpCGZTwJrHOIy6CyhQ1&typo=1)
and current and future treatments. Highlights from ICI-naïve patients:

§ 24-month OS rate of 74%; published 24-month OS less than 30% data with
approved ICIs for head and neck cancer.(2)

§ Well tolerated with no patients having Grade 4 or 5 combination
treatment-related adverse events. Thirteen percent with Grade 3 combination
treatment-related adverse events.

o  Presented biomarker data
(https://linkprotect.cudasvc.com/url?a=https%3a%2f%2fpdsbiotech.us4.list-manage.com%2ftrack%2fclick%3fu%3d407bd594246e0ad6fd93882af%26id%3d7a4af2a809%26e%3d27d88613f0&c=E,1,v5UCisi7O7-FTJc6D2iDWNQq4qZKAfLMjlOXjIo_J5LDnLwS_u-StbYF_s80A3cQGb3B5A4cL1ZUTcosj76KOPnJXyIyNYY-OZ2QvcWC1GKs6U5wdHs,&typo=1)
at European Society for Medical Oncology Congress 2023, highlighting that the
combination of PDS0101 and KEYTRUDA(®) has the potential to promote a TH1
immune response which is known to promote a strong CD8 T cell response.
Biomarker data demonstrated that the combination promotes the induction of
HPV16-specific multifunctional CD8 T cells.

·   IMMUNOCERV: Phase 2 clinical trial investigating PDS0101 in
combination with standard-of-care (SOC) chemoradiotherapy (CRT) in the
treatment of locally advanced cervical cancer patients with large tumours over
5 cm in size and/or cancer that has spread to the lymph nodes.

o  Data
(https://linkprotect.cudasvc.com/url?a=https%3a%2f%2fpdsbiotech.us4.list-manage.com%2ftrack%2fclick%3fu%3d407bd594246e0ad6fd93882af%26id%3de3037e563f%26e%3d27d88613f0&c=E,1,8JpZuK19J3JO05zPG75QgJ5Y8EIQSfdSJ1GYMu5CsZEoyQY4Sruhm1BHU31I26EZ4jSPrkTTKamVrsNQ5MwJ1m166Ikd_z9DJTk473awkLC6RlpFLCU4KqM3Qw,,&typo=1)
presented at American Society for Radiation Oncology 2023 Annual Meeting
demonstrated PDS0101, in combination with SOC CRT, was associated with a rapid
decline in HPV circulating cell-free DNA, a potential predictive biomarker of
treatment response. Ninety-two percent reduction in ctDNA with PDS0101 and SOC
and 53% reduction was seen with SOC at 5 weeks.

 

PDS01ADC (formerly known as PDS0301): IL12 Fused Antibody Drug Conjugate

 

·    NCI-led Triple Combination: Phase 2 clinical trial for combination
therapy of PDS0101, PDS01ADC and an investigational ICI for the treatment of
recurrent/metastatic HPV-positive, ICI-naïve and ICI-resistant HPV16-positive
cancers including anal, cervical, head and neck, vaginal and vulvar cancers.

o  ICI-naïve group:

§ 75% of patients remain alive at 36 months; published median OS data in
similar patients is 7-11 months.(1) The median OS has not yet been reached.

o  ICI-resistant group:

§ 12-month OS rate of 72%.

§ Median OS approximately 20 months; published median OS in HPV-positive
ICI-resistant cancer is 3.4 months(3).

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

·    NCI-led PDS01ADC + Docetaxel: Phase 1/2, open-label, single-arm
trial of PDS01ADC in combination with docetaxel in advanced mCSPC and mCRPC.

o  Presented interim safety and immune response data
(https://linkprotect.cudasvc.com/url?a=https%3a%2f%2fpdsbiotech.us4.list-manage.com%2ftrack%2fclick%3fu%3d407bd594246e0ad6fd93882af%26id%3d533f88efc9%26e%3d27d88613f0&c=E,1,h4EJPa0fHaPSYogWyRASNPOOvBZhoBrCE_PpOxKr7CQxR-ZntrPy3EvTcV5YtnjofZt_pjzFdl5qbUHXy0z6kyW9a-8M9HbPQppTgmEvHaM,&typo=1)
of the combination in the first clinical trial of an immunocytokine with
docetaxel in prostate cancer patients at Cytokines 2023.

o  Decrease in PSA levels was seen in all patients at all three tested doses
of PDS01ADC and 61% of patients had at least a 60% decrease in PSA levels.

§ All doses of the combination were well tolerated with one patient
experiencing Grade 4 neutropenia.

·     Presented data
(https://linkprotect.cudasvc.com/url?a=https%3a%2f%2fpdsbiotech.us4.list-manage.com%2ftrack%2fclick%3fu%3d407bd594246e0ad6fd93882af%26id%3d458b6bc0f1%26e%3d27d88613f0&c=E,1,W4QZJ56Dt8D10UWKefF1cvqmjghfdwlLvxkaM0qZo9dAGtqd6tzx0PV1gJzhZ9HDFvJEajO6-1ui9hllRpy6eOXegmwYBRg7vxpgdR14pw,,&typo=1)
from the NCI-led preclinical study evaluating PDS0101, PDS01ADC and an HDAC
inhibitor at the Society for Immunotherapy of Cancer's 38(th) Annual Meeting,
demonstrating anti-tumour activity against ICI-resistant cancers.

 

PDS0202 Universal Flu Candidate

 

·     Presented data
(https://linkprotect.cudasvc.com/url?a=https%3a%2f%2fpdsbiotech.us4.list-manage.com%2ftrack%2fclick%3fu%3d407bd594246e0ad6fd93882af%26id%3ddf382bc531%26e%3d27d88613f0&c=E,1,HKchptFFqqkdL315lmoCcerBCmN89SyvipA48gyJlENiraets18tvltgD9bHocO9jvAcCDYssk5gCUdej2iHG0jPByU2Jvq7J8AfO0oNGztQ967FAhBl1w,,&typo=1)
from the preclinical universal flu vaccine program at 9th European Scientific
Working Group on Influenza, demonstrating the potential ability of PDS0202 to
neutralize multiple influenza viruses. PDS0202 also demonstrated the ability
to prevent viral replication in the lungs of ferrets and provide complete
protection after challenge with lethal doses of the H1N1 influenza virus.

 

Third Quarter 2023 Financial Results

 

Net loss for the three months ended September 30, 2023 was approximately $10.8
million, or $0.35 per basic share and diluted share, compared to a net loss of
approximately $7.4 million, or $0.26 per basic and diluted share, for the
three months ended September 30, 2022. The higher net loss reported for the
three months ended September 30, 2023 is primarily due to the increase in
research and development expenses and general and administrative expenses.

 

Research and development expenses increased to $6.4 million for the three
months ended September 30, 2023 from $4.4 million for the three months ended
September 30, 2022. The increase of $2.0 million is primarily attributable to
an increase of $1.3 million in clinical trials, and $0.7 million in personnel
costs, including $0.3 million in non-cash stock-based compensation.

 

General and administrative expenses increased to $4.1 million for the three
months ended September 30, 2023 from $2.9 million for the three months ended
September 30, 2022. The increase of $1.2 million is primarily attributable to
an increase of $0.7 million in personnel costs, including $0.5 million in
non-cash stock-based compensation, and $0.5 million in investor relations
costs.

 

PDS Biotech's cash balance as of September 30, 2023 was approximately $54.3
million. PDS Biotech believes that, with initiating the VERSATILE-003 Phase 3
clinical trial in the first quarter of 2024, its available cash resources will
sustain operational and research and development endeavours into the third
quarter of 2024. PDS Biotech expects to execute its current operational and
research and development endeavours by obtaining additional capital,
principally through entering into collaborations, strategic alliances or
license agreements with third parties and/or additional public or private debt
and/or equity financings. The Company has had and continues to provide, what
the Company believes to be favourable development milestones to the market and
has upcoming development milestones.

 

 

References:

 

(1) Baumi J, et al. J Clin Oncol 2017:1542-49 and Morris VK, et al. Lancet
Oncol 2017;18:446-53.

 

(2)Ferris R.L., Nivolumab for Recurrent Squamous-Cell Carcinoma of the Head
and Neck; N Engl J Med 2016; 375:1856-1867; Burtness B et al., Pembrolizumab
alone or with chemotherapy versus cetuximab with chemotherapy for recurrent or
metastatic squamous cell carcinoma of the head and neck (KEYNOTE- 048): a
randomized, open-label phase 3 study; Lancet 2019; 394(10212):1915-1928. *No
control or comparative studies have been conducted between immune checkpoint
inhibitors and PDS0101.
https://www.opdivo.com/head-and-neck-cancer
(https://linkprotect.cudasvc.com/url?a=https%3a%2f%2fwww.opdivo.com%2fhead-and-neck-cancer&c=E,1,3-zzT24cs0fTMu4TZuAv2GrgFLHR3sqHguUTXrMtWFP0WXtxVgRBtpb2IZvoCBs_mAlFWnzfZseXilQYh8l55XS0J0Z_FWbnM1xAXDsTI__TX2Ylmcua&typo=1&ancr_add=1)

https://www.keytruda.com/head-and-neck-cancer/keytruda-clinical-trials/
(https://linkprotect.cudasvc.com/url?a=https%3a%2f%2fwww.keytruda.com%2fhead-and-neck-cancer%2fkeytruda-clinical-trials%2f&c=E,1,7cYVaWPWlPax6_sZkjKKC7fvEoD6TBgj9Dwrbg84oXN8umom8uFgUtzLuHyKETUuhWUYokbpFYaWZ2EhKBCIfcN0OXE_XG6yWPVUDfFqVQ,,&typo=1&ancr_add=1)

 

(3) Strauss J et al. Journal for ImmunoTherapyof Cancer 2020;8:e001395

 

 

About PDS0101

PDS0101, PDS Biotech's lead candidate, is a novel investigational human
papillomavirus (HPV)-targeted immunotherapy that stimulates a potent targeted
T cell attack against HPV-positive cancers. PDS0101 is given by subcutaneous
injection alone or in combination with other immunotherapies and cancer
treatments. In a Phase 1 study of PDS0101 in monotherapy, the treatment
demonstrated the ability to generate multifunctional HPV16-targeted CD8 and
CD4 T cells with minimal toxicity. Interim data suggests PDS0101 generates
clinically active immune responses, and the combination of PDS0101 with other
treatments can demonstrate significant disease control by reducing or
shrinking tumours, delaying disease progression and/or prolonging survival.
The combination of PDS0101 with other treatments does not appear to compound
the toxicity of other agents.

 

About PDS01ADC

PDS01ADC, formerly PDS0301, is a novel investigational tumour-targeting
antibody drug conjugate of Interleukin 12 (IL-12) that enhances the
proliferation, potency and longevity of T cells and natural killer cells in
the tumour microenvironment. PDS01ADC is given by subcutaneous injection and
is designed to improve the safety profile of IL-12 and to enhance the
anti-tumour response.

 

The Condensed Consolidated Balance Sheets; The Condensed Consolidated
Statements of Operations and Comprehensive Loss (Unaudited) and the Condensed
Consolidated Statements of Cash Flows

(Unaudited) are available on the full version of PDS Biotech's announcement.

 

A full version of PDS Biotech's announcement can be accessed here:

https://pdsbiotech.com/index.php/investors/news-center/press-releases/press-releases1/125-2023-news/886-iotecheportshirduarter2023inancialesultsan20231114
(https://pdsbiotech.com/index.php/investors/news-center/press-releases/press-releases1/125-2023-news/886-iotecheportshirduarter2023inancialesultsan20231114)

 

-Ends-

 

For more information, please contact:

 

 NetScientific
 Ilian Iliev, CEO                                               Via Belvedere Communications

 Panmure Gordon (UK) Limited (NOMAD and Broker)
 Emma Earl / Freddy Crossley / 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-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 (http://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(®), Versamune(®) plus PDS01ADC, and
Infectimune(®) 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® 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 plan to advance into a Phase 3 clinical
trial in combination with KEYTRUDA(®) for the treatment of
recurrent/metastatic HPV16-positive head and neck cancer in the first quarter
2024. Our Infectimune(®) 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.

 

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

 

 

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