PDS Biotech is a clinical-stage immunotherapeutic company developing treatments for cancer and infectious diseases. The proprietary T-cell activating platform Versamune is being employed to deliver disease-specific antigens to treat cancers and infectious diseases. The disease-specific T-cells and neutralizing antibodies effectively attack and destroy cancer cells and infectious organisms.
The lead asset is PDS0101 (HPV16) intended for the treatment of recurrent metastatic head and neck cancer, cervical cancer, and human papillomavirus-related cancers. Several other pipelines include PDS0102 for breast and prostate cancers, PDS0103 for ovarian, lung, and colorectal cancers, and PDS0104 for melanoma. The vaccine pipelines include PDS0203 for COVID-19 prophylaxis and PDS0202 for the influenza vaccine.
PDS0101 is an experimental HPV-targeted immunotherapy for targeted T-cells against various HPV-associated cancers. PDS0101 is being investigated as a combined therapywith immunotherapies and other anti-cancer drugs. The USFDA has granted fast-track designation for PDS0101 with Pembrolizumab for advanced head and neck cancer. According to recent studies, the PDS0101-based triplet regimen demonstrated sustained benefits with improved overall survival rates in difficult-in-treat HPV+ cancers without causing additional side effects.
PDS0102 is a novel T-cell receptor gamma alternate reading frame protein (TARP)-targeted immunotherapy to effectively treat TARP-positive cancers. PDS0102 can be administered as a monotherapy or a combined therapy with other immunotherapies. In an early study, PDS0102 elicited a significant immune response with remarkable tumor shrinking with delayed disease progression.
PDS0103 is an experimental mucin-1-specific immunotherapy to treat MUC-1-positive cancers. The immunotherapy can be administered as a monotherapy or as a combined therapy with other immunotherapies. PDS0103 is best suited to employ the Versamune platform to treat MUC1-related cancers.
Recent Activity
February 9th, 2023 – PDS biotech announces preclinical findings “We are encouraged by the data reported in Viruses which suggest that Infectimune™ is a promising platform for the effective delivery of recombinant protein antigens to the immune system and activation of the immune system for the development of next‐generation universal vaccines against respiratory viruses, including influenza and SARS-CoV-2,” stated Dr. Lauren V. Wood, Chief Medical Officer of PDS Biotech
January 13th, 2023 – PDS Biotech participated at the B. Riley Securities 3rd Annual Oncology Conference
January 3rd, 2023 – PDS Biotech, Merck Germany entered licensing pact for investigational cancer treatment
December 22nd, 2023 – PDS Biotech reported a median Overall Survival (OS) of 21 Months in advanced, refractory cancer patients having few remaining treatment options and with reported historical survival of 3-4 months
November 14th, 2022 – PDS Biotech reported third-quarter 2022 financial results and provides a business update.
Addressable Market
The global HPV-related cancer treatment market size was valued atUSD 710 million in 2020 and is estimated to hit around USD 23.2 billion by 2026 at a CAGR of 4.5%. The market size is expected to be driven by increasing prevalence rate, various HPV strains and associated cancers, and penetration of approved treatment options.
Current Finance
As of November 2022, the company had a cash position of USD 71.61 million. The total asset was USD 74.89 million, an increase of 33.7% from Q2 2022.
With a total debt of USD 375.25K, the company generated less than USD 1 million in revenue. The net profit was down by -6.66% to USD 7.42 million in Q3 2022. The company is currently unprofitable and not forecasted to be profitable over the next three years.
PDSB’s total assets were USD 74.89 million, a significant increase of 33.72% from Q2 2022. The total liabilities increased by 5.80% to USD 4.84 million.
Over the past three months, the share price was significantly volatile (+/-17%).
As of Q3 2022, the free cash flow was USD-5.89 million and the cash burn rate was USD 2.47 million. The net used cash was 9.92 million with USD 61.73 million as remaining cash. With remaining cash of USD 61.73 million, the forecasted cash runway is 24.6 months of cash.
Insider Activity
Competitors
Some of the main competitors of PDSB are Biotech Acquisition (BIOT), Actinium Pharmaceuticals (ATNM), and Rani Therapeutics (RANI).
Summary
The potential clinical success of PDS0101 as a treatment option for various HPV-related cancers could be a game-changer in the field. Receiving marketing approval for at least two of these cancers would meet a long-standing need. The versatility of Versamune as a drug delivery platform has the potential to enhance the effectiveness of treatments for both oncological and infectious diseases.
There are no imminent catalyst events for short-term investment, as PDSB is currently valued at around $250 million, making it a micro– or small-cap biotech company. Any partnership, announcement, or data release would have a significant impact on the share price. This stock carries both high risk and high reward, and retail investors are optimistic about its potential as shown below;
