Netscientific Regulatory News (NSCI)

NetScientific plc

("NetScientific", the "Group" or the "Company")

NetScientific plc (AIM: NSCI), the international life sciences and sustainability technology investment and commercialisation Group, announces that its portfolio company, PDS Biotechnology Corporation (Nasdaq: PDSB), today provided a business update and second-quarter financial results for the year ended December 31, 2022.

PDS Highlights for the Period

· Announced results from two of the ongoing Phase 2 clinical trials of PDS0101 in multiple, difficult-to-treat HPV16-related cancers presented at the American Society of Clinical Oncology meeting

· Promising pre-clinical data on universal flu vaccine program presented at American Society of Virology meeting

· Granted Fast Track Designation by U.S. Food and Drug Administration (FDA) for PDS0101 in combination with KEYTRUDA® (pembrolizumab) for the treatment of recurrent or metastatic HPV16-positive head and neck cancer.

· Presented data from 17 evaluable patients (efficacy) enrolled in the VERSATILE-002 Phase 2 clinical trial at the American Society of Clinical Oncology (ASCO) 2022 Annual Meeting, demonstrating clinical efficacy (objective response rate [ORR] plus stable disease) in 76.5% of patients.

· Announced acceptance of clinical trial application to expand VERSATILE-002 Phase 2 trial of PDS0101 in combination with KEYTRUDA® (pembrolizumab) into the United Kingdom.

· Presented data from 30 patients enrolled in National Cancer Institute-led triple combination Phase 2 clinical trial of PDS0101 in advanced, refractory HPV-positive cancers at ASCO 2022:

o  88% of checkpoint inhibitor (CPI)-naïve patients achieving an ORR (tumor shrinkage >30%). In published studies with CPI monotherapy, ORR ranged from 13-24%.

o  77% of CPI refractory patients were alive at a median of 12 months. In published studies, historical median survival rates for CPI refractory patients is 3-4 months. 

· Presented data from pre-clinical universal flu vaccine program at the American Society of Virology meeting, demonstrating the ability of PDS0202, the Company's Infectimune™ candidate formulated with Computationally Optimized Broadly Reactive Antigens (or COBRA) influenza antigens, to neutralize multiple strains of influenza, including H1N1, and provide protection against infection with lethal challenge in animals. 

· Strengthened leadership team with addition of Spencer Brown as Senior Vice President and General Counsel, and Sanjay Zaveri as Senior Vice President, Business Development.

Second Quarter 2022 Financial ResultsNet loss for the three months ended June 30, 2022 was approximately $5.8 million, or ($0.20) per basic share and diluted share, compared to a net loss of approximately $0.6 million, or ($0.03) per basic share and diluted share, for the three months ended June 30, 2021. The higher net loss reported for the three months ended June 2022 is primarily due to additional costs for expansion of the Company's research and development, including costs associated with our ongoing clinical trials, additional general and administrative costs, and lower income tax benefit.

Research and development expenses increased to $3.8 million for the three months ended June 30, 2022 from $2.8 million for the three months ended June 30, 2021. The increase of $1.0 million in 2022 was primarily attributable to an increase of $0.4 million in clinical study and research costs, $0.7 million in personnel costs, and $0.1 million in facilities, partially offset by a decrease of $0.2 million in manufacturing services. 

General and administrative expenses increased to $3.3 million for the three months ended June 30, 2022 from $2.3 million for the three months ended June 30, 2021. The increase of $1.0 million is primarily attributable to an increase of $0.8 million in personnel costs and $0.2 million in legal fees.

Total operating expenses were approximately $7.1 million for the three months ended June 30, 2022, from approximately $5.1 million for the three months ended June 30, 2021. 

PDS Biotech's cash balance as of June 30, 2022 was approximately $53.0 million.

The full text of the announcement from PDS Biotechnology is available online here: PDS Biotech - PDS Biotech Provides Business Update and Reports Second Quarter 2022 Financial Results

Dr. Ilian Iliev, CEO of NetScientific, commented: "We are pleased with the continued progress by PDS Biotech in its Phase 2 trials and broader corporate development, coming despite the ongoing volatility in the biotech public markets. We look forward to further results from its clinical development programme."

NetScientific holds 4.71% of PDS on an undiluted basis.

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About NetScientific

NetScientific plc (AIM: NSCI) is a holding company, that invests in, develops, commercialises and realises shareholder value in life sciences/healthcare, sustainability and technology companies, which offer significant growth potential predominately in the UK, EU and USA.

With the acquisition of EMV Capital in August 2020 and further investment activities, the Group more than doubled its portfolio from 8 to 22 companies. These are held as direct subsidiary and minority stakes, through balance sheet investment or capital under advisory, varying from start-up private companies to publicly listed equities. 

NetScientific delivers shareholder returns through a proactive and hands-on management approach to their portfolio companies; identifying, investing in, and helping to build game-changing companies. The Group targets value inflection points and the release of value through partial or full exits from trade sales, public listings, or equity sales. The Company has a strong transatlantic and growing international presence, providing attractive expansion prospects. 

NSCI can deploy a capital-light investment structure; utilising the power of the PLC Brand, and the NetScientific balance sheet to anchor future investments and achieve a multiplier effect by attracting 3rd party investment for the portfolio companies. 

NetScientific is headquartered in London, United Kingdom, and was admitted to trading on AIM, a market operated by the London Stock Exchange, in 2013 (website: netscientific.net).