- 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
CEO Comments:
“We are pleased with the outcome of the
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, fueled 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 multicenter 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, multicenter clinical trial of PDS0101 in combination with KEYTRUDA® in patients with HPV16-positive recurrent and/or metastatic head and neck cancer.
- Hosted KOL roundtable on interim VERSATILE-002 data 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.
- Presented biomarker data 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.
- Hosted KOL roundtable on interim VERSATILE-002 data and current and future treatments. Highlights from ICI-naïve patients:
- 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 tumors over 5 cm in size and/or cancer that has spread to the lymph nodes.
- Data 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.
- Data presented at
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.
- 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.
- 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 months3.
- Responses were seen in all HPV-positive tumor types.
- ICI-naïve group:
- NCI-led PDS01ADC + Docetaxel: Phase 1/2, open-label, single-arm trial of PDS01ADC in combination with docetaxel in advanced mCSPC and mCRPC.
- Presented interim safety and immune response data of the combination in the first clinical trial of an immunocytokine with docetaxel in prostate cancer patients at Cytokines 2023.
- 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 from the NCI-led preclinical study evaluating PDS0101, PDS01ADC and an HDAC inhibitor at the
Society for Immunotherapy of Cancer’s 38th Annual Meeting, demonstrating antitumor activity against ICI-resistant cancers.
PDS0202 Universal Flu Candidate
- Presented data 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
Research and development expenses increased to
General and administrative expenses increased to
PDS Biotech’s cash balance as of
Conference Call and Webcast
The conference call is scheduled to begin at
1 Baumi J, et al. J Clin Oncol 2017:1542-49 and Morris VK, et al. Lancet Oncol 2017;18:446-53.
2Ferris 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;
https://www.opdivo.com/head-and-neck-cancer
https://www.keytruda.com/head-and-neck-cancer/keytruda-clinical-trials/
3 Strauss J et al.
About PDB 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 tumors 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. To learn more, please visit www.pdsbiotech.com or follow us on Twitter at @PDSBiotech.
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 tumors, 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 tumor-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 tumor microenvironment. PDS01ADC is given by subcutaneous injection and is designed to improve the safety profile of IL-12 and to enhance the anti-tumor response.
Forward Looking Statements
This communication contains forward-looking statements (including within the meaning of Section 21E of the United States Securities Exchange Act of 1934, as amended, and Section 27A of the United States Securities Act of 1933, as amended) concerning
Versamune® and Infectimune® are registered trademarks of
Investor Contact:
Phone: +1 (404) 736-3838
Email: pdsb@cg.capital
Media Contact:
6 Degrees
Phone: +1 (917) 797-7904
Email: gcestari@6degreespr.com
PDS BIOTECHNOLOGY CORPORATION AND SUBSIDIARY | |||||||
Condensed Consolidated Balance Sheets | |||||||
ASSETS | (unaudited) | ||||||
Current assets: | |||||||
Cash and cash equivalents | $ | 54,251,387 | $ | 73,820,160 | |||
Prepaid expenses and other assets | 2,587,025 | 2,660,230 | |||||
Total current assets | 56,838,412 | 76,480,390 | |||||
Property and equipment, net | 138,866 | - | |||||
Financing lease right-of-use assets | 210,543 | 374,888 | |||||
Operating lease right-of-use asset | - | 152,645 | |||||
Total assets | $ | 57,187,821 | $ | 77,007,923 | |||
LIABILITIES AND STOCKHOLDERS' EQUITY | |||||||
Current liabilities: | |||||||
Accounts payable | $ | 5,366,564 | $ | 1,219,287 | |||
Accrued expenses | 3,732,727 | 8,313,708 | |||||
Financing lease obligation-short term | 54,537 | 56,612 | |||||
Operating lease obligation-short term | - | 231,429 | |||||
Total current liabilities | 9,153,828 | 9,821,036 | |||||
Noncurrent liabilities: | |||||||
Note payable, net of debt discount | 23,412,764 | 23,020,844 | |||||
Financing lease obligation-long term | 137,401 | 164,013 | |||||
Total liabilities: | $ | 32,703,993 | $ | 33,005,893 | |||
STOCKHOLDERS' EQUITY | |||||||
Common stock, | 10,233 | 9,956 | |||||
Additional paid-in capital | 158,075,994 | 145,550,491 | |||||
Accumulated deficit | (133,602,399 | ) | (101,558,417 | ) | |||
Total stockholders' equity | 24,483,828 | 44,002,030 | |||||
Total liabilities and stockholders' equity | $ | 57,187,821 | $ | 77,007,923 |
PDS BIOTECHNOLOGY CORPORATION AND SUBSIDIARY | |||||||||||||||||||||||
Condensed Consolidated Statements of Operations and Comprehensive Loss | |||||||||||||||||||||||
(Unaudited) | |||||||||||||||||||||||
Three Months Ended | Nine Months Ended | ||||||||||||||||||||||
2023 | 2022 | 2023 | 2022 | ||||||||||||||||||||
Operating expenses: | |||||||||||||||||||||||
Research and development expenses | $ | 6,448,528 | $ | 4,352,987 | $ | 20,297,066 | $ | 13,275,947 | |||||||||||||||
General and administrative expenses | 4,071,158 | 2,926,209 | 12,341,207 | 9,575,122 | |||||||||||||||||||
Total operating expenses | 10,519,686 | 7,279,196 | 32,638,273 | 22,851,069 | |||||||||||||||||||
Loss from operations | (10,519,686 | ) | (7,279,196 | ) | (32,638,273 | ) | (22,851,069 | ) | |||||||||||||||
Interest income (expenses), net | |||||||||||||||||||||||
Interest income | 739,404 | 252,073 | 2,219,399 | 332,318 | |||||||||||||||||||
Interest expense | (1,068,887 | ) | (397,327 | ) | (3,031,129 | ) | (397,326 | ) | |||||||||||||||
Interest income (expenses), net | (329,483 | ) | (145,254 | ) | (811,730 | ) | (65,008 | ) | |||||||||||||||
Loss before income taxes | (10,849,169 | ) | (7,424,450 | ) | (33,450,003 | ) | (22,916,077 | ) | |||||||||||||||
Benefit for income taxes | - | - | 1,406,021 | 1,198,905 | |||||||||||||||||||
Net loss and comprehensive loss | (10,849,169 | ) | (7,424,450 | ) | (32,043,982 | ) | (21,717,172 | ) | |||||||||||||||
Per share information: | |||||||||||||||||||||||
Net loss per share, basic and diluted | $ | (0.35 | ) | $ | (0.26 | ) | $ | (1.04 | ) | $ | (0.76 | ) | |||||||||||
Weighted average common shares outstanding, basic, and diluted | 30,910,520 | 28,458,688 | 30,715,458 | 28,452,997 |
PDS BIOTECHNOLOGY CORPORATION AND SUBSIDIARY | |||||||
Condensed Consolidated Statements of Cash Flows | |||||||
(Unaudited) | |||||||
Nine Months Ended | |||||||
2023 | 2022 | ||||||
Cash flows from operating activities: | |||||||
Net loss | $ | (32,043,982 | ) | $ | (21,717,172 | ) | |
Adjustments to reconcile net loss to net cash used in operating activities: | |||||||
Stock-based compensation expense | 6,259,464 | 3,821,923 | |||||
Issuance of shares in consulting agreement | 610,000 | - | |||||
Amortization of debt discount | 391,920 | 72,722 | |||||
Depreciation expense | 12,624 | 86 | |||||
Operating lease expense | 160,685 | 180,772 | |||||
Finance lease depreciation expense | 30,297 | 37,417 | |||||
Changes in assets and liabilities: | |||||||
Prepaid expenses and other assets | 73,205 | (1,171,337 | ) | ||||
Finance lease right-of-use asset | - | (306,487 | ) | ||||
Accounts payable | 4,147,277 | 727,987 | |||||
Accrued expenses | (4,580,981 | ) | 240,799 | ||||
Finance lease liabilities | - | 138,402 | |||||
Operating lease liabilities | (239,469 | ) | (205,885 | ) | |||
Net cash used in operating activities | (25,178,960 | ) | (18,180,773 | ) | |||
Cash Flows from financing activities: | |||||||
Proceeds from issuance of note payable | - | 25,000,000 | |||||
Payment for debt issuance costs | - | (449,329 | ) | ||||
Proceeds from exercise of stock options | 8,849 | 29,917 | |||||
Payments of finance lease obligations | (46,129 | ) | - | ||||
Proceeds from issuance of common stock, net of issuance costs | 5,647,467 | - | |||||
Net cash provided by financing activities | 5,610,187 | 24,580,588 | |||||
Net increase in cash and cash equivalents | (19,568,773 | ) | 6,399,815 | ||||
Cash and cash equivalents at beginning of period | 73,820,160 | 65,242,622 | |||||
Cash and cash equivalents at the end of period | $ | 54,251,387 | $ | 71,642,437 | |||
Source:
2023 GlobeNewswire, Inc., source