$PDSB
PDS Biotechnology Corp

2024 Q1 Form 10-K Financial Statement

#000114036124016265 Filed on March 28, 2024

View on sec.gov

Income Statement

Concept 2024 Q1 2023 Q4 2023
Revenue $0.00 $0.00 $0.00
YoY Change
Cost Of Revenue
YoY Change
Gross Profit
YoY Change
Gross Profit Margin
Selling, General & Admin $3.393M $2.941M $15.28M
YoY Change -5.18% 10.31% 24.84%
% of Gross Profit
Research & Development $6.704M $7.466M $27.76M
YoY Change 14.72% -53.79% -5.67%
% of Gross Profit
Depreciation & Amortization $4.735K $17.33K $57.33K
YoY Change 50.08% 49.65% 66562.79%
% of Gross Profit
Operating Expenses $10.10M $10.41M $43.05M
YoY Change 7.17% -44.71% 3.29%
Operating Profit -$10.10M -$43.05M
YoY Change 7.17% 3.29%
Interest Expense $1.175M -$491.3K -$1.303M
YoY Change 21.5% -198.97%
% of Operating Profit
Other Income/Expense, Net
YoY Change
Pretax Income -$10.60M -$10.90M -$44.35M
YoY Change 9.77% -43.05% 5.46%
Income Tax $0.00 -$1.406M
% Of Pretax Income
Net Earnings -$10.60M -$10.90M -$42.94M
YoY Change 9.77% -43.05% 5.11%
Net Earnings / Revenue
Basic Earnings Per Share -$0.30 -$1.39
Diluted Earnings Per Share -$0.30 -$0.34 -$1.39
COMMON SHARES
Basic Shares Outstanding 36.68M 31.11M 30.95M
Diluted Shares Outstanding 34.82M 30.95M

Balance Sheet

Concept 2024 Q1 2023 Q4 2023
SHORT-TERM ASSETS
Cash & Short-Term Investments $66.63M $56.56M $56.56M
YoY Change 2.2% -23.38% -23.38%
Cash & Equivalents $66.60M $56.56M $56.56M
Short-Term Investments
Other Short-Term Assets $2.051M $2.495M $2.495M
YoY Change -26.05% -6.23% -6.23%
Inventory
Prepaid Expenses
Receivables
Other Receivables
Total Short-Term Assets $68.69M $59.06M $59.06M
YoY Change 1.05% -22.78% -22.78%
LONG-TERM ASSETS
Property, Plant & Equipment $129.4K $335.0K $335.0K
YoY Change -12.77% -36.49%
Goodwill
YoY Change
Intangibles
YoY Change
Long-Term Investments
YoY Change
Other Assets
YoY Change
Total Long-Term Assets $320.6K $335.0K $335.0K
YoY Change -32.54% -36.5% -36.5%
TOTAL ASSETS
Total Short-Term Assets $68.69M $59.06M $59.06M
Total Long-Term Assets $320.6K $335.0K $335.0K
Total Assets $69.01M $59.39M $59.39M
YoY Change 0.81% -22.88% -22.88%
SHORT-TERM LIABILITIES
YoY Change
Accounts Payable $6.001M $6.983M $6.983M
YoY Change 189.61% 472.7% 472.7%
Accrued Expenses $1.714M $2.425M $2.425M
YoY Change -7.76% -70.84% -71.62%
Deferred Revenue
YoY Change
Short-Term Debt $0.00 $0.00 $0.00
YoY Change
Long-Term Debt Due $7.349M $4.222M $4.222M
YoY Change 14002.38% 7358.86% 7358.86%
Total Short-Term Liabilities $15.06M $13.63M $13.63M
YoY Change 264.78% 38.78% 38.78%
LONG-TERM LIABILITIES
Long-Term Debt $16.76M $19.63M $19.63M
YoY Change -28.1% -15.34% -15.34%
Other Long-Term Liabilities $0.00 $0.00
YoY Change
Total Long-Term Liabilities $16.76M $19.63M $19.63M
YoY Change -28.1% -15.34% -15.34%
TOTAL LIABILITIES
Total Short-Term Liabilities $15.06M $13.63M $13.63M
Total Long-Term Liabilities $16.76M $19.63M $19.63M
Total Liabilities $31.82M $33.26M $33.26M
YoY Change 15.98% 0.77% 0.77%
SHAREHOLDERS EQUITY
Retained Earnings -$155.1M -$144.5M
YoY Change 39.46% 42.28%
Common Stock $12.10K $10.92K
YoY Change 19.38% 9.69%
Preferred Stock
YoY Change
Treasury Stock (at cost)
YoY Change
Treasury Stock Shares
Shareholders Equity $37.18M $26.13M $26.13M
YoY Change
Total Liabilities & Shareholders Equity $69.01M $59.39M $59.39M
YoY Change 0.81% -22.88% -22.88%

Cashflow Statement

Concept 2024 Q1 2023 Q4 2023
OPERATING ACTIVITIES
Net Income -$10.60M -$10.90M -$42.94M
YoY Change 9.77% -43.05% 5.11%
Depreciation, Depletion And Amortization $4.735K $17.33K $57.33K
YoY Change 50.08% 49.65% 66562.79%
Cash From Operating Activities -$9.938M -$8.456M -$33.64M
YoY Change -24.65% 12.32% 30.83%
INVESTING ACTIVITIES
Capital Expenditures
YoY Change
Acquisitions
YoY Change
Other Investing Activities
YoY Change
Cash From Investing Activities
YoY Change
FINANCING ACTIVITIES
Cash Dividend Paid
YoY Change
Common Stock Issuance & Retirement, Net $16.44M
YoY Change 66.76%
Debt Paid & Issued, Net
YoY Change
Cash From Financing Activities 20.01M 10.77M 16.38M
YoY Change 338.11% 10.92% -52.24%
NET CHANGE
Cash From Operating Activities -9.938M -8.456M -33.64M
Cash From Investing Activities
Cash From Financing Activities 20.01M 10.77M 16.38M
Net Change In Cash 10.07M 2.310M -17.26M
YoY Change -216.86% 6.09% -301.22%
FREE CASH FLOW
Cash From Operating Activities -$9.938M -$8.456M -$33.64M
Capital Expenditures
Free Cash Flow
YoY Change

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<div style="text-align: justify; color: #000000; font-weight: bold; font-family: 'Times New Roman'; font-size: 10pt;">Note 1 – Nature of Operations</div> <div style="font-family: 'Times New Roman'; font-size: 10pt;"><span style="font-family: 'Times New Roman'; font-size: 10pt; background-color: rgb(255, 255, 255); font-weight: normal; color: rgb(0, 0, 0); font-style: normal; font-variant: normal; text-transform: none;"><br/> </span> </div> <div><span style="background-color: rgb(255, 255, 255); font-weight: normal; color: rgb(0, 0, 0); font-family: 'Times New Roman'; font-size: 10pt; font-style: normal; font-variant: normal; text-transform: none;"> </span></div> <div><span style="background-color: rgb(255, 255, 255); font-weight: normal; color: rgb(0, 0, 0); font-family: 'Times New Roman'; font-size: 10pt; font-style: normal; font-variant: normal; text-transform: none;"> </span></div> <div><span style="background-color: rgb(255, 255, 255); font-weight: normal; color: rgb(0, 0, 0); font-family: 'Times New Roman'; font-size: 10pt; font-style: normal; font-variant: normal; text-transform: none;"> </span></div> <div style="display:none;"><br/></div> <div style="text-align: justify; text-indent: 36pt; font-family: 'Times New Roman', Times, serif; font-size: 10pt;"><span style="font-size: 10pt; font-family: 'Times New Roman'; background-color: rgb(255, 255, 255); font-weight: normal; color: rgb(0, 0, 0); font-style: normal; font-variant: normal; text-transform: none;">PDS Biotechnology Corporation, </span><span style="color: rgb(0, 0, 0); font-family: 'Times New Roman'; font-size: 10pt; font-style: normal; font-variant: normal; font-weight: normal; letter-spacing: normal; text-align: justify; text-indent: 48px; text-transform: none; word-spacing: 0px; white-space: normal; background-color: rgb(255, 255, 255); text-decoration-style: initial; text-decoration-color: initial; display: inline ! important; float: none;">a Delaware corporation (the “Company” or “PDS Biotech”), is a clinical-stage immunotherapy company developing a growing pipeline of molecularly targeted immunotherapies designed to overcome the limitations of current immunotherapy and vaccine technologies. The Company develops proprietary platforms designed to train and enable the immune system to attack and destroy disease; Versamune®, and Versamune® in combination with PDS01ADC for treatments in oncology and Infectimune® for treatments in infectious diseases.  When paired with an antigen, which is a disease-related protein that is recognizable by the immune system, Versamune® and Infectimune® have both been shown to induce, </span><span style="color: rgb(0, 0, 0); font-family: 'Times New Roman'; font-size: 10pt; font-variant: normal; font-weight: normal; letter-spacing: normal; text-align: justify; text-indent: 48px; text-transform: none; word-spacing: 0px; white-space: normal; background-color: rgb(255, 255, 255); text-decoration-style: initial; text-decoration-color: initial; font-style: normal;">in vivo,</span><span style="color: rgb(0, 0, 0); font-family: 'Times New Roman'; font-size: 10pt; font-style: normal; font-variant: normal; font-weight: normal; letter-spacing: normal; text-align: justify; text-indent: 48px; text-transform: none; word-spacing: 0px; white-space: normal; background-color: rgb(255, 255, 255); text-decoration-style: initial; text-decoration-color: initial; display: inline ! important; float: none;"> large quantities of high-quality, highly potent polyfunctional CD4 helper and CD8 killer T cells, a specific sub-type of T cell that is more effective at killing infected or target cells. PDS01ADC is a novel investigational tumor-targeting fusion protein of Interleukin 12 that enhances the proliferation, potency, infiltration and longevity of T cells in the tumor microenvironment and is therefore designed to overcome the limitations of cytokine therapy which today has resulted in high toxicity and limited therapeutic potential.  Infectimune® is also designed to promote the induction of disease-specific neutralizing antibodies.  The Company’s immuno-oncology product candidates are of potential interest for use as a component of combination product candidates (for example, in combination with other leading technologies such as immune checkpoint inhibitors) to provide more effective treatments across a range of advanced and/or refractory cancers. The Company is also evaluating its immunotherapies as monotherapies in early-stage disease.  The Company is developing targeted product candidates to treat several cancers, including Human Papillomavirus (HPV) associated cancers, melanoma, colorectal, lung, breast and prostate cancers. The Company’s infectious disease candidate is of potential interest for use in universal influenza vaccines.</span></div> <div><span style="font-family: 'Times New Roman'; font-size: 10pt;"><br/> </span></div> <div style="display:none;"><br/></div> <div style="text-align: justify; color: rgb(0, 0, 0); text-indent: 36pt; font-family: 'Times New Roman'; font-size: 10pt;">The Company has received numerous patents, submitted patent applications and owns substantial know-how and trade secrets related to its <span style="color: rgb(0, 0, 0); font-style: normal; font-variant: normal; font-weight: normal; letter-spacing: normal; text-align: justify; text-indent: 48px; text-transform: none; word-spacing: 0px; white-space: normal; background-color: rgb(255, 255, 255); text-decoration-style: initial; text-decoration-color: initial; display: inline ! important; float: none;">Versamune®</span> and PDS01ADC product platforms. PDS Biotech holds thirteen (13) U.S. patents with granted claims directed to its platform technology and twenty-four (24) pending U.S. patent applications. These issued patents will expire in 2026 to 2037. Should the more recently submitted patent applications currently in prosecution be issued, these will expire in 2033 through 2043 assuming no patent term extensions are granted. As of March 1, 2024, PDS Biotech holds seventy-four (74) issued foreign patents and forty-four (44) pending or published foreign patent applications.  Most of the Company’s international issued patents are issued in multiple countries including Europe, Japan and Australia, and all of which cover compositions of matter and methods of use related to its platform technology. These issued patents will expire in 2028-2037, or later if patent term extension applies. <span style="color: rgb(0, 0, 0); font-style: normal; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; text-align: justify; text-indent: 48px; text-transform: none; word-spacing: 0px; white-space: normal; background-color: rgb(255, 255, 255); text-decoration-style: initial; text-decoration-color: initial; display: inline ! important; float: none;">Included in the patents above is a patent protecting the use of Versamune® in combination wit<span style="background-color: rgb(255, 255, 255); color: rgb(0, 0, 0);">h</span></span><span style="background-color: rgb(255, 255, 255); color: rgb(0, 0, 0);"> PDS01ADC.</span></div> <div style="font-family: 'Times New Roman'; font-size: 10pt;"><span style="font-family: 'Times New Roman'; font-size: 10pt;"><br/> </span> </div> <div style="display:none;"><br/></div> <div style="text-align: justify; text-indent: 36pt; color: #000000; font-style: italic; font-family: 'Times New Roman'; font-size: 10pt;">Licensed patents</div> <div style="font-family: 'Times New Roman'; font-size: 10pt;"><span style="font-family: 'Times New Roman'; font-size: 10pt;"><br/> </span> </div> <div style="display:none;"><br/></div> <div style="text-align: justify; text-indent: 36pt; color: #000000; font-family: 'Times New Roman'; font-size: 10pt;"><span style="color: rgb(0, 0, 0); font-family: 'Times New Roman'; font-size: 10pt; background-color: rgb(255, 255, 255); font-weight: normal; font-style: normal; font-variant: normal; text-transform: none;">The Company </span><span style="color: rgb(0, 0, 0); font-family: 'Times New Roman'; font-size: 10pt; font-style: normal; font-variant: normal; font-weight: normal; letter-spacing: normal; text-align: justify; text-indent: 48px; text-transform: none; word-spacing: 0px; white-space: normal; background-color: rgb(255, 255, 255); text-decoration-style: initial; text-decoration-color: initial; display: inline ! important; float: none;">has licensed patented antigens from the U.S. government for use in its cationic lipid immunotherapies. The Company has licensed T cell receptor gamma alternate reading frame protein (“TARP”) from the National Cancer Institute (“NCI”) to develop and commercialize TARP peptide-based therapies in combination with the Company’s Versamune® technology and any other of the Company’s proprietary technologies for prostate and breast cancers and acute myeloid leukemia.  These patents are directed to immunogenic peptides and peptide derivatives for the treatment of prostate and breast cancer treatment and multi-epitope TARP peptide vaccine and uses thereof. These licensed antigens are incorporated in PDS0102 with Versamune®.  The Company has licensed mucin-1 (“MUC1”) novel highly immunogenic agonist epitopes of MUC1 developed by the National Cancer Institute. MUC1 is highly expressed in multiple solid tumors and has been shown to be associated with drug resistance and poor disease prognosis in breast, colorectal, lung and ovarian cancers, for which PDS0103 is being developed.  The Company has been granted patents and is pursuing additional patents that cover compositions and methods of use of cationic lipid immunotherapies with each of the licensed </span><span style="font-family: 'Times New Roman'; font-size: 10pt; background-color: rgb(255, 255, 255); font-weight: normal; color: rgb(0, 0, 0); font-style: normal; font-variant: normal; text-transform: none;">technologies.</span></div> <div style="font-family: 'Times New Roman'; font-size: 10pt;"><span style="font-family: 'Times New Roman'; font-size: 10pt;"><br/> </span> </div> <div style="display:none;"><br/></div> <div style="text-align: justify; text-indent: 36pt; color: #000000; font-family: 'Times New Roman'; font-size: 10pt;">The Company entered into a non-exclusive agreement to license Computationally Optimized Broadly Reactive Antigen (COBRA) with the University of Georgia Research Foundation. These antigens are developed by Dr. Ted Ross at the University of Georgia.  The Company believes the combination of these antigens along with its proprietary <span style="color: rgb(0, 0, 0); font-family: 'Times New Roman'; font-size: 10pt; font-style: normal; font-variant: normal; font-weight: normal; letter-spacing: normal; text-align: justify; text-indent: 48px; text-transform: none; word-spacing: 0px; white-space: normal; background-color: rgb(255, 255, 255); text-decoration-style: initial; text-decoration-color: initial; display: inline ! important; float: none;">Versamune®</span> technology has the potential to induce a broad immune response as a universal flu vaccine.</div> <div style="display:none;"><br/></div> <div style="text-align: justify; text-indent: 36pt; color: #000000; font-family: 'Times New Roman'; font-size: 10pt;"> <span style="font-family: 'Times New Roman'; font-size: 10pt;"><br/> </span> </div> <div style="display:none;"><br/></div> <div style="color: rgb(0, 0, 0); font-style: italic; font-family: 'Times New Roman'; font-size: 10pt; text-indent: -9pt; margin-left: 9pt;">Exclusive License Agreement</div> <div><span style="font-family: 'Times New Roman'; font-size: 10pt;"><br/> </span> </div> <div style="display:none;"><br/></div> <div style="text-align: justify; text-indent: 36pt; color: rgb(0, 0, 0); font-size: 10pt; font-family: 'Times New Roman';">On December 30, 2022, the Company entered into a License Agreement (the “License Agreement”) with Merck KGaA, Darmstadt, Germany, pursuant to which Merck KGaA, Darmstadt, Germany has granted the Company an exclusive (even as to Merck KGaA), worldwide, sublicensable, milestone and royalty-bearing right and license to certain patent rights and certain related data (the “Licensed Technology”) to develop, manufacture, use, commercialize and otherwise exploit any product containing NHS-IL12 fusion protein formerly known as M9241, now PDS01ADC.</div> <div><span style="font-size: 10pt; font-family: 'Times New Roman';"> </span></div> <div><span style="font-size: 10pt; font-family: 'Times New Roman';"> </span></div> <div><span style="font-size: 10pt; font-family: 'Times New Roman';"><br/> </span> </div> <div><span style="font-size: 10pt; font-family: 'Times New Roman';"> </span></div> <div style="display:none;"><br/></div> <div style="text-align: justify; text-indent: 36pt; color: rgb(0, 0, 0); font-size: 10pt; font-family: 'Times New Roman';">In consideration for the rights granted by Merck KGaA, Darmstadt, Germany, the Company (i) agreed to make a one-time up-front cash payment of $5.0 million to Merck KGaA, Darmstadt, Germany, and (ii) entered into a Share Transfer Agreement dated December 30, 2022  (the “Share Transfer Agreement”), pursuant to which the Company issued 378,787 shares of its common stock (the “Shares”) to Merck KGaA, Darmstadt, Germany in a private placement for an aggregate value of $5.0 million, as measured by the closing price of the Company’s common stock on the Nasdaq Capital Market as of December 30, 2022.<br/> </div> <div><span style="font-size: 10pt; font-family: 'Times New Roman';"> </span> <span style="font-size: 10pt; font-family: 'Times New Roman';"> </span> <span style="font-size: 10pt; font-family: 'Times New Roman';"> </span> <span style="font-size: 10pt; font-family: 'Times New Roman';"> </span></div> <div style="display:none;"><br/></div> <div style="text-align: justify; text-indent: 36pt; color: rgb(0, 0, 0); font-size: 10pt; font-family: 'Times New Roman';"><br/> </div> <div><span style="font-size: 10pt; font-family: 'Times New Roman';"> </span> <span style="font-size: 10pt; font-family: 'Times New Roman';"> </span> <span style="font-size: 10pt; font-family: 'Times New Roman';"> </span> <span style="font-size: 10pt; font-family: 'Times New Roman';"> </span></div> <div style="display:none;"><br/></div> <div style="color: rgb(0, 0, 0); font-family: 'Times New Roman'; font-size: 10pt; font-style: normal; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; text-transform: none; white-space: normal; word-spacing: 0px; background-color: rgb(255, 255, 255); text-decoration-style: initial; text-decoration-color: initial; text-align: justify; text-indent: 36pt;">Pursuant to the License Agreement, the Company agreed to make certain commercial sales milestone and royalty payments.</div>
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