PDS Biotech: 2nd Quarter Results, Business Update
RNS: For immediate release
NetScientific plc
PDS Biotechnology Reports Second Quarter 2023 Financial Results and Provides Business Update
Successful submission of final clinical protocol and supporting CMC information to FDA to initiate Phase 3 VERSATILE-003 trial in the fourth quarter 2023
Biomarker data from VERSATILE-002 to be presented at ESMO 2023
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 its proprietary T cell activating platforms, has released its financial results for the quarter ended 30 June 2023 and has provided a business update.
Recent Business Highlights:
PDS0101 Lead Drug Candidate
· VERSATILE-003: Submitted the final Phase 3 clinical protocol and supporting Chemistry, Manufacturing and Controls (CMC) information to the U.S. Food and Drug Administration (FDA) to enable initiation of the VERSATILE-003 randomized, controlled multicenter study of PDS0101 in combination with Merck's anti-PD-1 therapy, KEYTRUDA® (pembrolizumab) in patients with human papillomavirus (HPV) 16-positive recurrent and/or metastatic head and neck cancer in the fourth quarter 2023
· VERSATILE-002: Phase 2 open-label, multicenter study of PDS0101 in combination with KEYTRUDA® in patients with human papillomavirus (HPV) 16-positive recurrent and/or metastatic head and neck cancer
o Announced clinical immune response data to be presented at upcoming European Society for Medical Oncology (ESMO) Congress 2023
§ Biomarker data highlighting HPV16-specific killer and helper T cell responses will be presented
o Presented interim data at the 2023 American Society of Clinical Oncology (ASCO) annual meeting, demonstrating a 12-month overall survival rate of 87%, with only 8% of patients experiencing Grade 3 treatment-related adverse events, and no reports of more severe Grade 4 or 5 adverse events
o Achieved the efficacy threshold in Stage 2 of this clinical trial for the naïve patient arm
§ 14 patients in the immune checkpoint inhibitor (ICI) naïve arm experienced either a complete response or partial response on two consecutive scans 9-12 weeks apart, constituting a confirmed objective response. This result suggests that PDS0101 has a statistically significant additive effect over published results of ICI monotherapy
o Completed enrollment in the ICI naïve arm and expect final data readout in mid-2024
PDS0301 Antibody-Conjugated Interleukin 12 (IL-12)
· PDS0301 + docetaxel: Phase 2, open label, single-arm trial of PDS0301 in combination with docetaxel in metastatic castration sensitive and castration resistant prostate cancer, led by the National Cancer Institute (NCI)
o Announced selection of abstract for oral presentation by the NCI at the upcoming Cytokines 2023 Annual Meeting on 15-1 8October 2023
o The Phase 2 clinical trial is investigating the safety, immune responses, and clinical activity of the combination in metastatic prostate cancer patients
o First clinical trial of an immunocytokine with docetaxel in prostate cancer patients
Business Highlights
· PDS Biotech was added to the broad-market Russell 2000® and Russell 3000® Indexes in June 2023
Dr Frank Bedu-Addo, CEO of PDS Biotech, stated:
"We continue to make significant strides with our lead candidate, PDS0101, specifically with the regulatory and clinical activities necessary to initiate the VERSATILE-003 trial, as well as with progression of the Phase 2 VERSATILE-002 clinical trial. In the second quarter, at ASCO 2023, we presented interim data from VERSATILE-002 which revealed an impressive estimated 12-month overall survival rate of 87% and a progression-free survival of 10.4 months, while maintaining a favorable safety profile when PDS0101 is combined with KEYTRUDA®. The reported 12-month overall survival rate for immune checkpoint inhibitors is 30-50%. These encouraging findings fuel our enthusiasm as we prepare to initiate the Phase 3 VERSATILE-003 clinical trial in which patient overall survival will be the primary trial outcome in the fourth quarter of 2023.
"In addition to our enthusiasm for PDS0101, we are thrilled about the prospects of PDS0301 which we believe may potentially overcome some of the key safety and efficacy limitations of current cytokines. We are excited about the NCI's abstract acceptance at the upcoming Cytokines 2023 annual meeting. We anticipate these results have the potential to offer valuable insights into the use of PDS0301 in conjunction with chemotherapy for various solid tumors, presenting a promising avenue for future development and commercialization possibilities."
Dr Ilian Iliev, CEO of NetScientific, added:
"We are pleased to see the continued progress made by Frank and his team during the quarter, including with its lead candidate, PDS0101."
Second Quarter 2023 Financial Results
Net loss for the three months ended 30 June 2023 was approximately $11.5 million, or ($0.37) per basic share and diluted share, compared to a net loss of approximately $5.8 million, or ($0.20) per basic share and diluted share, for the three months ended 30 June 30 2022. The higher net loss this quarter was primarily due to costs incurred in connection with our research and development programs.
Research and development expenses increased to $8.0 million for the three months ended 30 June 2023 from $3.8 million for the three months ended 30 June 2022. The increase of $4.2 million is primarily attributable to an increase of $1.4 million in clinical trials, $0.5 million in personnel costs, including $0.2 million in non-cash stock-based compensation, and $2.3 million in manufacturing expenses.
General and administrative expenses increased to $4.7 million for the three months ended 30 June 2023 from $3.3 million for the three months ended 30 June 2022. The increase of $1.4 million is primarily attributable to an increase of $0.5 million in personnel costs, including $0.4 million in non-cash stock-based compensation and $0.9 million in professional fees.
Cash and cash equivalents as of 30 June 2023, totaled approximately $60.6 million. Based on the Company's cash resources, PDS Biotech believes this amount is sufficient to fund operations and research and development programs for 12 months following the filing of the Company's June 2023 Quarterly Report on Form 10-Q which will be filed as of the date of this press release.
A full version of PDS Biotech's announcement with more detailed financial information can be accessed here:
-Ends-
For more information, please contact:
NetScientific
Ilian Iliev, CEO Via Belvedere Communications
WH Ireland (NOMAD, Financial Adviser and Broker)
Chris Fielding / Darshan Patel +44 (0)20 7220 1666
Belvedere Communications
John West / Llew Angus +44 (0) 203 008 6867
Email: nsci@belvederepr.com
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.
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 PDS0301, 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 will be advancing into a Phase 3 clinical trial in combination with KEYTRUDA® for the treatment of recurrent/metastatic HPV16-positive head and neck cancer in 2023. 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. To learn more, please visit www.pdsbiotech.com or follow us on Twitter at @PDSBiotech.
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