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|
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(State or Other Jurisdiction of Incorporation)
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(Commission File Number)
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(I.R.S. Employer Identification No.)
|
|
Written communication pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
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Pre-commencement communication pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
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Pre-commencement communication pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
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Title of each class
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Trading Symbol(s)
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Name of each exchange on which registered
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Item 2.02 |
Results of Operation and Financial Condition.
|
Item 9.01 |
Financial Statements and Exhibits.
|
Exhibit
Number
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Description
|
|
Press Release dated November 14, 2023.
|
||
104
|
Cover Page Interactive Data File - the cover page interactive date file does not appear in the Interactive Date File because its XBRL tags are embedded within
the Inline XBRL document.
|
PDS BIOTECHNOLOGY CORPORATION
|
|
Date: November 14, 2023
|
By: /s/ Frank Bedu-Addo, Ph.D.
|
Name: Frank Bedu-Addo, Ph.D.
|
|
Title: President and Chief Executive Officer
|
• |
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
|
• |
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.
|
o |
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.
|
o |
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.
|
• |
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.
|
o |
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.
|
• |
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, ICInaïve and ICI-resistant HPV16-positive cancers including anal, cervical, head and
neck, vaginal and vulvar cancers.
|
o |
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.
|
o |
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.
|
o |
Responses were seen in all HPV-positive tumor types.
|
• |
NCI-led PDS01ADC + Docetaxel:
Phase 1/2, open-label, single-arm trial of PDS01ADC in combination with docetaxel in advanced mCSPC and mCRPC.
|
o |
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.
|
o |
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.
|
• |
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.
|
September 30, 2023
|
December 31, 2022
|
|||||||
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, $0.00033 par value, 75,000,000 shares authorized at September 30, 2023 and December 31, 2022, 31,007,763 shares and
30,170,317 shares issued and outstanding at September 30, 2023 and December 31, 2022, respectively
|
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
|
Three Months Ended September 30,
|
Nine Months Ended September 30,
|
|||||||||||||||
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
|
Nine Months Ended September 30,
|
||||||||
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
|
Document and Entity Information |
Nov. 14, 2023 |
---|---|
Cover [Abstract] | |
Document Type | 8-K |
Amendment Flag | false |
Document Period End Date | Nov. 14, 2023 |
Entity File Number | 001-37568 |
Entity Registrant Name | PDS BIOTECHNOLOGY CORPORATION |
Entity Central Index Key | 0001472091 |
Entity Incorporation, State or Country Code | DE |
Entity Tax Identification Number | 26-4231384 |
Entity Address, Address Line One | 303A College Road East |
Entity Address, City or Town | Princeton |
Entity Address, State or Province | NJ |
Entity Address, Postal Zip Code | 08540 |
City Area Code | 800 |
Local Phone Number | 208-3343 |
Title of 12(b) Security | Common Stock, par value $0.00033 per share |
Trading Symbol | PDSB |
Security Exchange Name | NASDAQ |
Entity Emerging Growth Company | false |
Written Communications | false |
Soliciting Material | false |
Pre-commencement Tender Offer | false |
Pre-commencement Issuer Tender Offer | false |
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