08/13/2024 | Press release | Distributed by Public on 08/13/2024 06:01
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Announced alignment with FDA to initiate Phase 3 VERSATILE-003 trial in HPV16-positive first-line recurrent or metastatic HNSCC.
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This trial will be designed to investigate the combination of Versamune® HPV + pembrolizumab compared to pembrolizumab, and this design reflects updated statistical endpoints based on recent and more mature survival data from the VERSATILE-002 trial.
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PDS Biotech has initiated preparatory activities in connection with the planned start of the Phase 3 VERSATILE-003 trial in Q4 2024.
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Abstract by Jared Weiss, M.D., UNC Lineberger Cancer Center (Lead Investigator), presenting updated data from the VERSATILE-002 trial evaluating first-line treatment with Versamune® HPV in combination with KEYTRUDA® (pembrolizumab) in patients with HPV16-positive recurrent/metastatic HNSCC accepted for presentation at the ESMO Congress 2024.
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Provided a survival data update from the ongoing VERSATILE-002 trial in HPV16-positive HNSCC based on data cut from May 17, 2024.
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Median overall survival is 30 months, consistent with data cut as of November 30, 2023.
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Abstract by Adam Grippin, M.D., Ph.D., of the University of Texas MD Anderson Cancer Center presenting updated results from the IMMUNOCERV trial evaluating treatment of high-risk locally advanced cervical cancer with Versamune® HPV in combination with chemoradiotherapy accepted for oral presentation at the American Society for Radiation Oncology (ASTRO) Annual Meeting 2024.
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Abstract by Renee Donahue, Ph.D., of the National Cancer Institute presenting preliminary biomarker results from a Phase 2 trial evaluating treatment of biochemically recurrent prostate cancer with PDS01ADC in combination with enzalutamide accepted for oral presentation at the 12th Annual Meeting of the International Cytokine and Interferon Society 2024.
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Three Months Ended June 30,
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Six Months Ended June 30,
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|||||||||||||||
2024
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2023
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2024
|
2023
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|||||||||||||
Operating expenses:
|
||||||||||||||||
Research and development expenses
|
$
|
4,527,698
|
$
|
8,004,852
|
$
|
11,231,862
|
$
|
13,848,538
|
||||||||
General and administrative expenses
|
$
|
4,156,606
|
$
|
4,691,321
|
$
|
7,550,069
|
$
|
8,270,049
|
||||||||
Total operating expenses
|
$
|
8,684,304
|
$
|
12,696,173
|
$
|
18,781,931
|
$
|
22,118,587
|
||||||||
Loss from operations
|
$
|
(8,684,304
|
)
|
$
|
(12,696,173
|
)
|
$
|
(18,781,931
|
)
|
$
|
(22,118,587
|
)
|
||||
Interest income (expense), net
|
||||||||||||||||
Interest income
|
$
|
675,209
|
$
|
750,654
|
$
|
1,344,104
|
$
|
1,479,995
|
||||||||
Interest expense
|
$
|
(1,187,971
|
)
|
$
|
(995,397
|
)
|
$
|
(2,362,716
|
)
|
$
|
(1,962,242
|
)
|
||||
Interest income (expense), net
|
$
|
(512,762
|
)
|
$
|
(244,743
|
)
|
$
|
(1,018,612
|
)
|
$
|
(482,247
|
)
|
||||
Loss before income taxes
|
$
|
(9,197,066
|
)
|
$
|
(12,940,916
|
)
|
$
|
(19,800,543
|
)
|
$
|
(22,600,834
|
)
|
||||
Benefit for income taxes
|
$
|
869,169
|
$
|
1,406,021
|
$
|
869,169
|
$
|
1,406,021
|
||||||||
Net loss and comprehensive loss
|
$
|
(8,327,897
|
)
|
$
|
(11,534,895
|
)
|
$
|
(18,931,374
|
)
|
$
|
(21,194,813
|
)
|
||||
Per share information:
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||||||||||||||||
Net loss per share, basic and diluted
|
$
|
(0.23
|
)
|
$
|
(0.37
|
)
|
$
|
(0.53
|
)
|
$
|
(0.69
|
)
|
||||
Weighted average common shares outstanding basic and diluted
|
36,693,561
|
30,802,498
|
35,754,715
|
30,613,310
|
June 30,
2024
|
December 31,
2023
|
|||||||
Cash and cash equivalents
|
$
|
57,733,724
|
$
|
56,560,517
|
||||
Working capital
|
$
|
44,486,702
|
$
|
45,425,098
|
||||
Total assets
|
$
|
60,495,947
|
$
|
59,390,080
|
||||
Long term debt
|
$
|
13,810,194
|
$
|
19,506,183
|
||||
Accumulated deficit
|
$
|
(163,431,989
|
)
|
$
|
(144,500,615
|
)
|
||
Total stockholders' equity
|
$
|
30,917,870
|
$
|
26,130,947
|