• |
Achieved several milestones in the VERSATILE-002 Phase 2 Combination Trial of PDS0101-KEYTRUDA® for recurrent and/or metastatic human papillomavirus (HPV)16-associated head and neck cancer. These milestones include:
|
o |
Achievement of the preliminary safety benchmark for the first 12 patients
|
o |
Completion of enrollment for the first stage of the checkpoint inhibitor naïve arm (1st line treatment of recurrent or metastatic head and neck cancer).
|
o |
Initiated enrollment of the second arm of the study addressing checkpoint inhibitor refractory patients (2nd line treatment of recurrent or metastatic head and neck cancer)
|
• |
Completed a licensing agreement with the National Cancer Institute (NCI) for intellectual property related to the NCI's proprietary T-cell receptor gamma alternate reading frame protein (TARP) tumor antigen for use in PDS0102.
|
o |
PDS0102 is being developed to treat prostate cancer, breast cancer and acute myeloid leukemia or AML.
|
o |
PDS0102 has demonstrated powerful induction of TARP-specific killer T-cells in preclinical studies.
|
• |
Entered agreement to license COBRA (Computationally Optimized Broadly Reactive Antigen) antigens from the University of Georgia for use in the development of PDS0202, a novel Versamune®-based universal flu vaccine.
|
• |
Announced temporary administrative suspension of enrollment into the NCI-led study of the PDS0101 triple combination. PDS Biotech continues to be in contact with the NCI. Treatment of already enrolled patients has continued without interruption.
|
• |
Announced the hiring of Matthew Hill as Chief Financial Officer, who has more than 20 years of experience in finance and operational leadership roles for life sciences companies.
|
September 30,
2021
|
December 31,
2020
| |||||||
ASSETS
|
(unaudited)
| |||||||
Current assets:
| ||||||||
Cash and cash equivalents
|
$
|
69,744,004
|
$
|
28,839,565
| ||||
Prepaid expenses and other
|
1,596,810
|
1,497,665
| ||||||
Total current assets
|
71,340,814
|
30,337,230
| ||||||
Property and equipment, net
|
1,037
|
5,443
| ||||||
Operating lease right-to-use asset
|
406,171
|
547,706
| ||||||
Total assets
|
$
|
71,748,022
|
$
|
30,890,379
| ||||
LIABILITIES AND STOCKHOLDERS' EQUITY
| ||||||||
LIABILITIES
| ||||||||
Current liabilities:
| ||||||||
Accounts payable
|
$
|
1,445,585
|
$
|
1,415,224
| ||||
Accrued expenses
|
1,923,846
|
1,735,322
| ||||||
Operating lease obligation-short term
|
207,717
|
119,904
| ||||||
Total current liabilities
|
3,577,148
|
3,270,450
| ||||||
Noncurrent liability:
| ||||||||
Operating lease obligation-long term
|
313,976
|
490,353
| ||||||
Total Liabilities
|
$
|
3,891,124
|
$
|
3,760,803
| ||||
STOCKHOLDERS' EQUITY
| ||||||||
Common stock, $0.00033 par value, 75,000,000 shares authorized at September 30, 2021 and December 31, 2020, 28,435,067 shares and 22,261,619 shares issued and outstanding at September 30, 2021 and December 31, 2020, respectively
|
9,383
|
7,346
| ||||||
Additional paid-in capital
|
122,231,115
|
70,907,315
| ||||||
Accumulated deficit
|
(54,383,600
|
)
|
(43,785,085
|
)
| ||||
Total stockholders' equity
|
67,856,898
|
27,129,576
| ||||||
Total liabilities and stockholders' equity
|
$
|
71,748,022
|
$
|
30,890,379
|
Three Months Ended September 30,
|
Nine Months Ended September 30,
| |||||||||||||||
2021
|
2020
|
2021
|
2020
| |||||||||||||
Operating expenses:
| ||||||||||||||||
Research and development expenses
|
$
|
3,687,999
|
$
|
2,060,815
|
$
|
7,865,249
|
$
|
5,446,718
| ||||||||
General and administrative expenses
|
3,274,325
|
1,846,214
|
7,252,371
|
5,428,098
| ||||||||||||
Total operating expenses
|
6,962,324
|
3,907,029
|
15,117,620
|
10,874,816
| ||||||||||||
Loss from operations
|
(6,962,324
|
)
|
(3,907,029
|
)
|
(15,117,620
|
)
|
(10,874,816
|
)
| ||||||||
Other income:
| ||||||||||||||||
Interest income
|
1,358
|
1,207
|
2,617
|
54,242
| ||||||||||||
Loss before income taxes
|
(6,960,966
|
)
|
(3,905,822
|
)
|
(15,115,003
|
)
|
(10,820,574
|
)
| ||||||||
Benefit from income taxes
|
-
|
-
|
4,516,488
|
-
| ||||||||||||
Net loss and comprehensive loss
|
(6,960,966
|
)
|
(3,905,822
|
)
|
(10,598,515
|
)
|
(10,820,574
|
)
| ||||||||
Per share information:
| ||||||||||||||||
Net loss per share, basic and diluted
|
$
|
(0.24
|
)
|
$
|
(0.21
|
)
|
$
|
(0.43
|
)
|
$
|
(0.73
|
)
| ||||
Weighted average common shares outstanding, basic and diluted
|
28,425,850
|
18,961,619
|
24,639,299
|
14,892,764
|
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Disclaimer
PDS Biotechnology Corporation published this content on 10 November 2021 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 10 November 2021 12:16:45 UTC.