Netscientific Regulatory News (NSCI)

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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

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.

· 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 >1) and

§ 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

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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

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.