PDS Biotechnology Corp [PDSB] Filings

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 10-K

(Mark One)

For the fiscal year ended December 31, 2023

For the transition period from ________to ________

Commission file number 001-37568

303A College Road East Princeton, NJ 08540

(Address of principal executive offices)

(800) 208-3343

(Registrant’s telephone number)

Securities registered pursuant to Section 12(b) of the Act:

Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. Yes ☐ No ☒

Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Act. Yes ☐ No ☒

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ☒ No ☐

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.  Yes ☐ No ☐

Indicate by check mark whether the registrant has filed a report on and attestation to its management’s assessment of the effectiveness of its internal control over financial reporting under Section 404(b) of the Sarbanes-Oxley Act (15 U.S.C. 7262(b)) by the registered public accounting firm that prepared or issued its audit report. ☐

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No ☒

The aggregate market value of the voting and non-voting common equity held by non-affiliates (without admitting that any person whose shares are not included in such calculation is an affiliate) of the registrant as of June 30, 2023, was $148,298,700 (based on the closing price for shares of the registrant’s common stock as reported on the Nasdaq Capital Market on that date).

The number of shares of the registrant’s common stock, par value $0.00033 per share, outstanding as of March 21, 2024 was 36,679,275.

Portions of registrant’s definitive proxy statement relating to registrant’s 2024 Annual Meeting of Stockholders (the “Proxy Statement”) to be filed with the Securities and Exchange Commission pursuant to Regulation 14A, not later than 120 days after the close of the registrant’s fiscal year ended December 31, 2023, are incorporated by reference in Part III of this Annual Report on Form 10-K. Except with respect to information specifically incorporated by reference in this Annual Report on Form 10-K, the Proxy Statement is not deemed to be filed as part of this Annual Report on Form 10-K.

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			PAGE
PART I
	Item 1	Business	4
	Item 1A	Risk Factors	48
	Item 1B	Unresolved Staff Comments	86
	Item 1C	Cybersecurity	86
	Item 2	Properties	86
	Item 3	Legal Proceedings	86
	Item 4	Mine Safety Disclosures	86
PART II
	Item 5	Market for Registrant’s Common Equity, Related Stockholder Matters and Issuers Purchases of Equity Securities	87
	Item 7	Management’s Discussion and Analysis of Financial Condition and Results of Operations	88
	Item 7A	Qualitative and qualitative disclosures about market risk	102
	Item 8	Financial Statements and Supplementary Data	102
	Item 9	Changes in and Disagreements with Accountants on Accounting and Financial Disclosure	103
	Item 9A	Controls and Procedures	103
	Item 9B	Other Information	103
	Item 9C	Disclosure Regarding Foreign Jurisdictions that Prevent Inspections	103
PART III
	Item 10	Directors, Executive Officers and Corporate Governance	104
	Item 11	Executive Compensation	104
	Item 12	Securities Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters	104
	Item 13	Certain Relationships and Related Transactions and Director Independence	104
	Item 14	Principal Accountant Fees and Services	104
PART IV
	Item 15	Exhibits and Financial Statement Schedules	104
	Item 16	Form 10-K Summary	104
Signatures			108

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the Company’s ability to protect its intellectual property rights;

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the Company’s anticipated capital requirements, including the Company’s anticipated cash runway and the Company’s current expectations regarding its plans for future equity financings;

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the Company’s dependence on additional financing to fund its operations and complete the development and commercialization of its product candidates, and the risks that raising such additional capital may restrict the Company’s operations or require the Company to relinquish rights to the Company’s technologies or product candidates;

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the Company’s limited operating history in the Company’s current line of business, which makes it difficult to evaluate the Company’s prospects, the Company’s business plan or the likelihood of the Company’s successful implementation of such business plan;

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the timing for the Company or its partners to initiate the planned clinical trials for its Versamune® products, including PDS0101, PDS0103, and others, alone or in combination with PDS01ADC (formerly known as PDS0301/M9241/NHS-IL-12), as well as Infectimune® based products and the future success of such trials

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the successful implementation of the Company’s research and development programs and collaborations, including any collaboration studies concerning Versamune®, PDS01ADC and Infectimune® based products and the Company’s interpretation of the results and findings of such programs and collaborations and whether such results are sufficient to support the future success of the Company’s product candidates;

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the success, timing and cost of the Company’s ongoing clinical trials and anticipated clinical trials for the Company’s current product candidates, including statements regarding the timing of initiation, pace of enrollment and completion of the trials (including our ability to fully fund our disclosed clinical trials, which assumes no material changes to our currently projected expenses), futility analyses, presentations at conferences and data reported in an abstract, and receipt of interim results (including, without limitation, any preclinical results or data), which are not necessarily indicative of the final results of the Company’s ongoing clinical trials;

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expectations for the clinical and preclinical development, manufacturing, regulatory approval, and commercialization of our product candidates;

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any Company statements about its understanding of product candidates’ mechanisms of action and interpretation of preclinical and early clinical results from its clinical development programs and any collaboration studies; the acceptance by the market of the Company’s product candidates, if approved;

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the timing of and the Company’s ability to obtain and maintain U.S. Food and Drug Administration or other regulatory authority approval of, or other action with respect to, the Company’s product candidates; and

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other factors, including legislative, regulatory, political and economic developments not within the Company’s control, including those listed under Part II, Item 1A. Risk Factors.

ITEM 1.

Business

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Stimulate both tumor-specific killer and helper T cells within the body

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Activate, arm and expand large numbers of T cells that recognize the tumor

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Minimize immune suppression in the tumor microenvironment (TME) to make the cancer more visible or susceptible to attack by the immune system

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Generate immune memory, so that there is a prolonged anti-tumor immune response to treatment

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Optimize safety and tolerability by limiting systemic inflammation and toxicity

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Objective response (OR = >30% tumor reduction) was seen in 88% (7/8) of patients with ICI naive disease; 4/7 (57%) patients’ responses were ongoing (median 17 months).

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With ICI resistant patients: PDS01ADC dosing appeared to affect response rates, with 5/8 (63%) patients receiving PDS01ADC at 16.8 mcg/kg achieving an OR compared to 1/14 (7%) patients who received PDS01ADC at 8 mcg/kg achieving an OR; 4/6 (67%) patients’ responses were ongoing (median 12 months).

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Tumor reduction was seen in 45% (10/22) of patients with ICI resistant disease, including patients receiving high or low dose PDS01ADC.

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In ICI resistant patients treated with high or low dose PDS01ADC, survival outcomes were similar (p=0.96 by Kaplan Meier analysis). At a median of 12 months of follow up 17/22 (77%) of patients were alive.

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In ICI naïve patients 6/8 (75%) were alive at median 17 months of follow up.

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Similar OR and survival were seen across all types of HPV16-positive cancers.

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Preliminary safety data: 13/30 (43%) of patients experienced Grade 3 treatment-related adverse events (AEs), and 2/30 patients (7%) experienced Grade 4 AEs. There were no grade 5 treatment-related AEs.

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Survival data:  66% (19/29) of HPV16-positive ICI resistant patients in the cohort were alive at a median follow up of 16 months.

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Safety profile: 48% (24/50) patients experienced Grade 3 treatment-related adverse events (AEs), and 4% (2/50) patients experienced Grade 4 AEs. There were no Grade 5 treatment-related AEs.

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HPV16-positive ICI naïve patients: 75% (6/8) were alive at a median follow up of 25 months and 38% (3/8) of responders had a complete response.

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Median OS was 21 months in 29 checkpoint inhibitor resistant patients who received the triple combination. The reported historical median OS in patients with ICI resistant disease is 3-4 months seen with checkpoint inhibitors and best reported median survival to date with systemic therapy of 8.2 months in ICI resistant head and neck cancer.

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In ICI naïve subjects, 75% remained alive at a median follow-up of 27 months.  As a result, median OS had not yet been reached. Historically, observed median OS for similar patients with platinum experienced ICI naïve disease is 7-11 months.

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Objective response rate (ORR) in ICI resistant patients who received the optimal dose of the triple combination is 63% (5/8).  In current approaches ORR is reported to be less than 10%.

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ORR in ICI naïve patients with the triple combination was reported as 88%. In current approaches, ORR is reported to be less than 25% with FDA-approved ICIs in HPV-positive cancers.

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Safety data had not changed since October’s update. 48% (24/50) of patients experienced Grade 3 (moderate) treatment-related adverse events (AEs), and 4% (2/50) patients experienced Grade 4 (severe) AEs, compared with approximately 70% of patients receiving the combination of ICIs and chemotherapy reporting Grade 3 and higher treatment-related AEs.

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Confirmed and unconfirmed objective response rates (ORR) thus far (tumor shrinkage greater than 30%) was seen in 7/17 (41.2%) patients with 2 of the 7 having complete responses (CR). Published results state ORR of approximately 19% for approved ICIs, used as monotherapy for recurrent or metastatic head and neck cancer.

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Stable disease (SD) was reported in 6/17 (35.3%) patients, with 4 of the 6 (67%) experiencing tumor shrinkage of less than 30%

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Clinical efficacy (ORR + SD) was seen in 13/17 (76.5%) patients

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Progressive/ongoing disease was reported in 4/17 (23.5%) patients

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Patients had received a median of 4/5 doses of PDS0101 (range 1-5) and 9/35 doses of Keytruda® (range 1-18)

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There were no treatment-related adverse events greater than or equal to Grade 3 (N=19)

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No patients required dose interruption or reduction on the combination treatment

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No patients discontinued the combination treatment

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At 9 months of follow up (median not yet achieved):

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No control or comparative studies have been conducted between ICIs and PDS0101

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Estimated 12-month overall survival rate was 87.1%. Published results are 36-50% with approved ICIs used alone.

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Median progression-free survival was 10.4 months (95% CI 4.2, 15.3). Published results are median PFS of 2-3 months for approved ICIs when used as monotherapy in patients with similar PD-L1 levels.

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A disease control rate (disease stabilization or tumor shrinkage) of 70.6% (24/34)

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Confirmed and unconfirmed objective response rate is 41.2% (14/34 patients), which is identical to the preliminary response rate data PDS Biotech previously reported at ASCO 2022 (7/17 patients). To date, these responses have been confirmed in 9 of the 34 patients (26.5%), including one complete response.

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15/34 patients (44.1%) had stable disease.

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9/34 patients (26.5%) had progressive disease.

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4/48 (8.3%) of patients had a Grade 3 treatment-related adverse event (TRAE). No Grade 4 or higher TRAEs were observed.

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9 of the 17 patients had completed a Day 170 post-treatment Positron Emission Tomography, Computed Tomography (PET CT) scan to assess the status of the cancer. This included 78% (7/9) of treated patients with advanced cervical cancer (FIGO stage III or IV).

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100% (9/9) of patients treated with the combination of PDS0101 and CRT had an objective response.

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89% (8/9) of patients treated with the combination of PDS0101 and CRT demonstrated a complete response (CR) on Day 170 by PET CT. One patient who received 3 of the 5 scheduled doses of PDS0101 showed signs of residual disease. One patient who had a CR died from an event unrelated to either their underlying disease or treatment.

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1-year disease-free survival and 1-year overall survival of 89% (8/9) in patients treated with the combination of PDS0101 and CRT.

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As previously reported, data confirm PDS0101 treatment activates HPV16-specific CD8 T cells. This increase was not seen in patients who did not receive PDS0101. The increase in HPV16-specific T cells generated by the treatment is positively correlated with tumor cell death, suggesting cytotoxic CD8 T cells are important mediators of antigen-specific immunity.

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Toxicity of PDS0101 remains limited to low-grade local injection site reactions.

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the timing and costs of our planned clinical trials and manufacturing of our clinical products;

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the timing and costs of our planned preclinical studies of our lead program of Versamune® PDS0101 in combination with PDS01ADC and an immune checkpoint inhibitor, as well as other earlier-stage programs;

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the outcome, timing and costs of seeking regulatory approvals;

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the ability to repay debt financings including interest payments;

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the terms and timing of any future collaborations, licensing, consulting or other arrangements that we may enter into;

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the amount and timing of any payments we may be required to make in connection with the licensing, filing, prosecution, maintenance, defense and enforcement of any patents or patent applications or other intellectual property rights; and

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the extent to which we license or acquire other products and technologies.

Name	​	Age	​	Position
Frank Bedu-Addo, Ph.D.	​	59	​	President, Chief Executive Officer, Principal Executive Officer and Director
Gregory L. Conn, Ph.D.	​	69	​	Chief Scientific Officer
Kirk V. Shepard, M.D.	​	72	​	Chief Medical Officer
Lars Boesgaard	​	54	​	Chief Financial Officer, Principal Financial Officer and Principal Accounting Officer
Spencer Brown	​	54	​	Senior Vice President, General Counsel, Chief Compliance Officer

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completion of nonclinical laboratory tests and animal studies according to good laboratory practice regulations, or GLP, and applicable requirements for the humane use of laboratory animals or other applicable regulations;

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submission to the FDA of an investigational new drug application, or an IND, which must become effective before human clinical studies may begin;

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approval by an independent institutional review board, or IRB, representing each clinical site before each clinical trial may be initiated;

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performance of adequate and well-controlled human clinical studies according to the FDA’s regulations commonly referred to as good clinical practice, or GCP, and any additional requirements for the protection of human research subjects and their health information, to establish the safety and efficacy of the proposed biological product for its intended use;

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submission to the FDA of a Biologics License Application, or BLA, for marketing approval that meets applicable requirements to ensure the continued safety, purity, and potency/efficacy of the product that is the subject of the BLA based on results of nonclinical testing and clinical studies (including among other things clinical data, chemistry, and manufacturing and controls (CMC) data);

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review by an FDA advisory committee, where appropriate or if applicable;

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satisfactory completion of an FDA inspection of the manufacturing facility or facilities where the biological product, or components thereof, are produced, to assess compliance with cGMP, and to assure that the facilities, methods and controls are adequate to preserve the biological product’s identity, strength, quality and purity;

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pre-approval inspection by the FDA of the sponsor (or any third-party service providers) relative to oversight of clinical studies, clinical trial sites that generated the data in support of the BLA, and any manufacturing facilities to assure compliance with GCPs and the integrity of clinical data;

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payment of user fees;

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FDA review and approval, or licensure, of the BLA; and

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Compliance with any post-approval requirements, including the potential requirement to implement a Risk Evaluation and Mitigation Strategy, or REMS, and the potential requirement to conduct post-approval studies

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Phase 1. The biological product is initially introduced into healthy human subjects and tested for safety. In the case of some products for severe or life-threatening diseases, especially when the product may be too inherently toxic to ethically administer to healthy volunteers, the initial human testing is often conducted in seriously ill subjects. These studies are designed to test the safety, dosage tolerance, absorption, metabolism and pharmacologic actions of the investigational product in humans, the side effects associated with increasing doses, and, if possible, to gain early evidence of effectiveness.

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Phase 2. The biological product is evaluated in a limited patient population to identify possible adverse effects and safety risks, to preliminarily evaluate the efficacy of the product for specific targeted diseases and to determine dosage tolerance, optimal dosage and dosing schedule. Multiple Phase 2 clinical studies may be conducted to obtain information prior to beginning larger and more expensive Phase 3 clinical studies.

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Phase 3. The biological product is administered to an expanded patient population, generally at geographically dispersed clinical trial sites, in well-controlled clinical trials to generate enough data to statistically evaluate the dosage, clinical efficacy, potency, and safety of the product for approval, to establish the overall risk to benefit ratio of the product and provide an adequate basis for product labeling.

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Phase 4. Post-approval studies, which are conducted following initial approval, are typically conducted to gain additional experience and data from treatment of patients in the intended therapeutic indication.

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restrictions on the marketing or manufacturing of the product, including total or partial suspension of production, complete withdrawal of the product from the market or product recalls;

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fines, warning or untitled letters or holds on post-approval clinical trials;

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refusal of the FDA to approve pending BLAs or supplements to approved BLAs, or suspension or revocation of product license approvals;

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product seizure or detention, or refusal to permit the import or export of products; or

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injunctions or the imposition of civil or criminal penalties.

ITEM 1A.

Risk Factors

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We have a limited operating history and have never generated any product revenue.

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We have incurred significant losses since our inception and expect to continue to incur significant losses for the foreseeable future and may never achieve or maintain profitability.

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We are dependent on the success of our Versamune® and Infectimune® products, which are still in early-stage clinical development, and if our Versamune® and Infectimune® products do not receive regulatory approval or are not successfully commercialized, our business may be harmed.

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We will require additional capital to fund our operations, and if we fail to obtain necessary financing, we may not be able to complete the development and commercialization of our Versamune® and Infectimune® based products.

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Raising additional funds by issuing securities may cause dilution to existing stockholders and raising funds through lending and licensing arrangements may restrict our operations or require us to relinquish proprietary rights.

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We will need to expand our organization, and may experience difficulties in managing this growth, which could disrupt operations.

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Clinical trials are very expensive, time-consuming, difficult to design and implement and involve an uncertain outcome, and if they fail to demonstrate safety and efficacy to the satisfaction of the FDA, or similar regulatory authorities, we will be unable to commercialize Versamune®, Versamune® in combination with PDS01ADC and Infectimune® based products.

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Enrollment and retention of subjects in clinical trials is an expensive and time-consuming process and could be made more difficult or rendered impossible by multiple factors outside our control.

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We face significant competition from other biotechnology and pharmaceutical companies, and our operating results will suffer if we fail to compete effectively.

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Our product candidates are in various stages of development and we will not be able to commercialize our product candidates if our preclinical studies do not produce successful results and/or our clinical trials do not demonstrate the safety and efficacy of our product candidates; early results and early understanding of product candidate potential may not be predictive of later success.

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If we fail to comply with federal and state healthcare regulatory laws, including in our relationships with healthcare providers and customers and third-party payors, we could face criminal prosecution and sanctions, substantial civil penalties, damages, fines, disgorgement, exclusion from participation in governmental healthcare programs, contractual damages, reputational harm, and the curtailment of our operations, any of which could harm our business.

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If we are unable to establish sales, marketing and distribution capabilities either on our own or in collaboration with third parties, we may not be successful in commercializing PDS0101, PDS01ADC and other product candidates, if approved.

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We have no manufacturing, sales, marketing or distribution capability and we must rely upon third parties for such.

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set and obtain an acceptable price for Versamune® based immunotherapy candidates, including Versamune® in combination with PDS01ADC, and obtain coverage and adequate reimbursement from third-party payors;

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establish sales, marketing, manufacturing and distribution systems;

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add operational, financial and management information systems and personnel, including personnel to support our clinical, manufacturing and planned future clinical development and commercialization efforts and operations as a public company;

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develop manufacturing capabilities for bulk materials and manufacture commercial quantities of Versamune® PDS0101, PDS01ADC and other Versamune® products at acceptable cost levels;

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achieve broad market acceptance of PDS0101 and other Versamune®, Versamune® in combination with PDS01ADC and Infectimune® based-products in the medical community and with third-party payors and consumers;

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attract and retain an experienced management and advisory team;

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launch commercial sales of Versamune® PDS0101 in combination with PDS01ADC and other oncology products, and Infectimune® based-products, whether alone or in collaboration with others; and

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maintain, expand and protect our intellectual property portfolio.

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we may not be able to demonstrate that PDS0101 alone or in combination with PDS01ADC is safe and effective to the satisfaction of the FDA;

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the FDA may not agree that the completed Phase 2 clinical trials of PDS0101 and PDS01ADC satisfy the FDA’s requirements and may require us to conduct additional testing;

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the results of our future clinical trials may not meet the level of statistical or clinical significance required by the FDA for marketing approval;

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the FDA may disagree with the number, design, size, conduct or implementation of one or more of our clinical trials;

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the contract research organizations, or CROs, that we retain to conduct clinical trials may take actions outside of our control that materially and adversely impact our clinical trials;

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the FDA may not find the data from our preclinical studies and clinical trials sufficient to demonstrate that the clinical and other benefits of PDS0101 and PDS01ADC outweigh the safety risks;

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the FDA may disagree with our interpretation of data from our preclinical studies and clinical trials;

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the FDA may not accept data generated at our clinical trial sites;

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if our BLA is reviewed by an advisory committee, the FDA may have difficulties scheduling an advisory committee meeting in a timely manner or the advisory committee may recommend against approval of our application or may recommend that the FDA require, as a condition of approval, additional preclinical studies or clinical trials, limitations on approved labeling or distribution and use restrictions;

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the FDA may require development of a risk evaluation and mitigation strategy, or REMS, as a condition of approval;

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the FDA may identify deficiencies in our manufacturing processes or facilities; or

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the FDA may change its approval policies or adopt new regulations.

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the initiation, progress, timing, costs and results of our planned clinical trials;

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the outcome, timing and cost of meeting regulatory requirements established by the FDA and other comparable foreign regulatory authorities;

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the cost of filing, prosecuting, defending and enforcing our patent claims and other intellectual property rights;

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the cost of defending potential intellectual property disputes, including any patent infringement actions brought by third parties against us now or in the future;

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the effect of competing technological and market developments;

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the cost of establishing sales, marketing and distribution capabilities in regions where we choose to commercialize PDS0101 and PDS01ADC on our own; and

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the initiation, progress, timing and results of the commercialization of PDS0101, if approved, for commercial sale.

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the efficacy and safety of the product;

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the potential advantages of the product compared to alternative therapies;

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the prevalence and severity of any side effects;

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whether the product is designated under physician and other provider treatment guidelines as a first-, second- or third-line therapy;

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our ability, or the ability of any future collaborators, to offer the product for sale at competitive prices;

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the product’s convenience and ease of administration for patients and healthcare practitioners compared to alternative treatments;

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the willingness of the target patient population to try, and of physicians to prescribe, the product;

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limitations or warnings, including distribution or use restrictions and safety information contained in the product’s approved labeling;

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the strength of sales, marketing and distribution support;

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changes in the standard of care for the targeted indications for the product; and

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the availability of coverage by, and the amount of reimbursement from, government payors, managed care plans and other third-party payors.

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obtaining regulatory authorization to commence a trial;

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reaching agreement on acceptable terms with prospective contract research organizations, or CROs, and clinical trial sites, the terms of which can be subject to extensive negotiation and may vary significantly among different CROs and clinical trial sites;

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obtaining institutional review board or ethics committee approval at each clinical trial site;

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recruiting suitable patients to participate in a trial;

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patients failing to comply with the clinical trial protocol or dropping out of a trial;

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clinical trial sites failing to comply with the clinical trial protocol or dropping out of a trial;

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addressing any conflicts with new or existing laws or regulations;

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the need to add new clinical trial sites;

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manufacturing sufficient quantities of product candidate for use in clinical trials and ensuring clinical trial material is provided to clinical sites in a timely manner; or

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obtaining advice from regulatory authorities regarding the statistical analysis plan to be used to evaluate the clinical trial data or other trial design issues.

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we may receive feedback from regulatory authorities that requires us to modify the design of our clinical trials;

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clinical trials of our product candidates may produce negative or inconclusive results, and we may decide, or regulators may require us, to conduct additional clinical trials or abandon drug development programs;

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the number of patients required for clinical trials of our product candidates may be larger than we anticipate, enrollment in these clinical trials may be slower than we anticipate or participants may drop out of these clinical trials at a higher rate than we anticipate;

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our third-party contractors, including our CROs, may fail to comply with regulatory requirements or meet their contractual obligations to us in a timely manner, or at all;

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we, our investigators, or any of the overseeing IRBs or ethics committees might decide to suspend or terminate clinical trials of our product candidates for various reasons, including non-compliance with regulatory requirements, a finding that our product candidates have undesirable side effects or other unexpected characteristics, or a finding that the participants are being exposed to unacceptable health risks;

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the cost of clinical trials of our product candidates may be greater than we anticipate;

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the supply or quality of our product candidates or other materials necessary to conduct clinical trials of our product candidates may be insufficient or inadequate;

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regulators may revise the requirements for approving our product candidates, or such requirements may not be as we anticipate; and

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any future collaborators that conduct clinical trials may face any of the above issues and may conduct clinical trials in ways they view as advantageous to them but that are suboptimal for us.

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If we are required to conduct additional clinical trials or other testing of our product candidates beyond those that we currently contemplate, if we are unable to successfully complete clinical trials of our product candidates or other testing, if the results of these trials or tests are not positive or are insufficiently positive to support marketing approval, or if there are safety concerns, we may:

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incur unplanned costs;

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be delayed in obtaining marketing approval for our product candidates or not obtain marketing approval at all;

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obtain marketing approval in some countries and not in others;

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obtain marketing approval for indications or patient populations that are narrower or more limited in scope than intended or desired;

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obtain marketing approval subject to significant use or distribution restrictions or with labeling that includes significant safety warnings, including boxed warnings;

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be subject to additional post-marketing testing requirements; or

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have the drug removed from the market after obtaining marketing approval.

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successful initiation, successful patient enrollment and timely completion of clinical trials of these products;

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successful initiation and successful patient enrollment and completion of additional clinical trials, for our product candidates;

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our ability to demonstrate our products’ safety, tolerability and efficacy to the FDA or any comparable foreign regulatory authority for marketing approval;

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timely receipt of marketing approvals for our products;

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obtaining and maintaining patent protection, trade secret protection and regulatory exclusivity, both in the United States and internationally;

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successfully defending and enforcing our rights in our intellectual property portfolio;

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avoiding and successfully defending against any claims that we have infringed, misappropriated or otherwise violated any intellectual property of any third party;

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the performance of our future collaborators, if any;

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the extent of, and our ability to timely complete, any required post-marketing approval commitments imposed by FDA or other applicable regulatory authorities;

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establishment of supply arrangements with third-party raw materials and drug product suppliers and manufacturers who are able to manufacture clinical trial and commercial quantities of our products and their components and to develop, validate and maintain a commercially viable manufacturing process that is compliant with current good manufacturing practices, or cGMP, at a scale sufficient to meet anticipated demand and over time enable us to reduce our cost of manufacturing;

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establishment of scaled production arrangements with third-party manufacturers to obtain finished products that are compliant with cGMP and appropriately packaged for sale;

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successful launch of commercial sales following any marketing approval;

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a continued acceptable safety profile following any marketing approval;

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commercial acceptance by patients, the medical community and third-party payors;

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the availability of coverage and adequate reimbursement and pricing by third-party payors and government authorities;

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the availability, perceived advantages, relative cost, relative safety and relative efficacy of alternative and competing treatments; and

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our ability to compete with other therapies.

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regulatory authorities may withdraw their approval of PDS0101 or PDS01ADC or impose restrictions on its distribution or other risk management measures;

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regulatory authorities may require the addition of labeling statements, such as warnings or contraindications;

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we may be required to change the way PDS0101 or PDS01ADC is administered or to conduct additional clinical trials;

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we could be sued and held liable for injuries sustained by patients;

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we could elect to discontinue the sale of PDS0101 or PDS01ADC;

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our entire Versamune® and Infectimune®-based pipeline could be then put at risk; and

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our reputation may suffer.

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restrictions on manufacturing PDS0101 or PDS01ADC;

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restrictions on the labeling or marketing of PDS0101 or PDS01ADC;

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restrictions on distribution or use of PDS0101 or PDS01ADC;

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requirements to conduct post-marketing studies or clinical trials;

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suspension of any of our ongoing clinical trials;

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warning letters;

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withdrawal of PDS0101 or PDS01ADC from the market;

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refusal to approve pending applications or supplements to approved applications that we submit;

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recalls of PDS0101 or PDS01ADC;

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fines, restitution or disgorgement of profits or revenues;

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suspension or withdrawal of marketing approvals;

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refusal to permit the import or export of PDS0101 or PDS01ADC;

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seizures of PDS0101 or PDS01ADC; or

●

injunctions or the imposition of civil or criminal penalties.

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the efficacy and potential advantages compared to alternative treatments;

●

effectiveness of sales and marketing efforts;

●

the cost of treatment in relation to alternative treatments;

●

our ability to offer PDS0101 or PDS01ADC for sale at competitive prices;

●

the convenience and ease of administration compared to alternative treatments;

●

the willingness of the target patient population to try new therapies and of physicians to prescribe these therapies;

●

the willingness of the medical community to offer customers PDS0101 or PDS01ADC in addition to or in the place of other immunotherapies;

●

the strength of marketing and distribution support;

●

the availability of third-party coverage and adequate reimbursement;

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whether the product is designated under physician and other provided treatment guidelines as a first, second, or third line therapy;

●

the prevalence and severity of any side effects; and

●

any restrictions on the use of PDS0101 or PDS01ADC together with other medications.

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decreased demand for PDS0101, PDS01ADC or other immunotherapies that we may develop;

●

injury to our reputation and significant negative media attention;

●

withdrawal of clinical trial participants;

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significant costs to defend any related litigation;

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substantial monetary awards to trial subjects or patients;

●

loss of revenue; and

●

the inability to commercialize any products we may develop.

●

different regulatory requirements for drug approvals and rules governing drug commercialization in foreign countries;

●

reduced protection for intellectual property rights;

●

unexpected changes in tariffs, trade barriers and regulatory requirements;

●

economic weakness, including inflation, or political instability in particular foreign economies and markets;

●

compliance with tax, employment, immigration and labor laws for employees living or traveling abroad;

●

foreign reimbursement, pricing and insurance regimes;

●

foreign taxes;

●

foreign currency fluctuations, which could result in increased operating expenses and reduced revenues, and other obligations incident to doing business in another country;

●

workforce uncertainty in countries where labor unrest is more common than in the United States;

●

potential noncompliance with the U.S. Foreign Corrupt Practices Act, the U.K. Bribery Act 2010 and similar anti-bribery and anticorruption laws in other jurisdictions;

●

shortages resulting from any events affecting raw material supply or manufacturing capabilities abroad; and

●

business interruptions resulting from geopolitical actions, including war and terrorism, or natural disasters including earthquakes, typhoons, floods and fires.

●

the possible failure of the third party to manufacture our product candidate according to our schedule, or at all, including if our third-party contractors give greater priority to the supply of other products over our product candidates or otherwise do not satisfactorily perform according to the terms of the agreements between us and them;

●

the possible termination or nonrenewal of agreements by our third-party contractors at a time that is costly or inconvenient for us;

●

the possible breach by the third-party contractors of our agreements with them;

●

the failure of third-party contractors to comply with applicable regulatory requirements;

●

the possible failure of the third party to manufacture our product candidates according to our specifications;

●

the possible mislabeling of clinical supplies, potentially resulting in issues including the wrong dose amounts being supplied or active drug or placebo not being properly identified;

●

the possibility of clinical supplies not being delivered to clinical sites on time, leading to clinical trial interruptions, or of drug supplies not being distributed to commercial vendors in a timely manner, resulting in lost sales; and

●

the possible misappropriation of our proprietary information, including our trade secrets and know-how.

●

significant time and effort from our management team;

●

financial funding to support said collaboration;

●

coordination of our research and development programs with the research and development priorities of our collaborators; and

●

effective allocation of our resources to multiple projects.

●

delays or difficulties in enrolling patients in our clinical trials;

●

delays or difficulties in initiating or expanding clinical trials, including delays or difficulties with clinical site initiation and recruiting clinical site investigators and clinical site staff;

●

diversion of healthcare resources away from the conduct of clinical trials, including the diversion of hospitals serving as our clinical trial sites and hospital staff supporting the conduct of our clinical trials;

●

interruption of key clinical trial activities, such as clinical trial site data monitoring, due to limitations on travel imposed or recommended by federal or state governments, employers and others or interruption of clinical trial subject visits and study procedures, which may impact the integrity of subject data and clinical study endpoints;

●

interruption or delays in the operations of the FDA or other regulatory authorities, which may impact review and approval timelines;

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delays or disruptions in preclinical experiments and investigational new drug application-enabling studies due to restrictions of on-site staff and unforeseen circumstances at contract research organizations and vendors;

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interruption of, or delays in receiving, supplies of our product candidates from our contract manufacturing organizations due to staffing shortages, production slowdowns or stoppages and disruptions in delivery systems;

●

limitations on our ability to recruit and hire key personnel due to our inability to meet with candidates because of travel restrictions and “shelter in place” orders;

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limitations on employee resources that would otherwise be focused on the conduct of our preclinical studies and clinical trials, including because of sickness of employees or their families or the desire of employees to avoid contact with large groups of people; and

●

interruption or delays to our sourced discovery and clinical activities.

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the ability of us and our partners to develop product candidates and conduct clinical trials that demonstrate such product candidates are safe and effective;

●

the ability of us or our partners to obtain regulatory approvals for product candidates, and delays or failures to obtain such approvals;

●

failure of any of our product candidates to demonstrate safety and efficacy, receive regulatory approval and achieve commercial success;

●

failure by us to maintain our existing third-party license, manufacturing and supply agreements;

●

failure by us or our licensors to prosecute, maintain, or enforce our intellectual property rights;

●

changes in laws or regulations applicable to our product candidates;

●

any inability to obtain adequate supply of product candidates or the inability to do so at acceptable prices;

●

adverse regulatory authority decisions;

●

introduction of new or competing products by our competitors;

●

failure to meet or exceed financial and development projections we may provide to the public;

●

the perception of the pharmaceutical industry by the public, legislatures, regulators and the investment community;

●

announcements of significant acquisitions, strategic partnerships, joint ventures, or capital commitments by us or our competitors;

●

disputes or other developments relating to proprietary rights, including patents, litigation matters, and our ability to obtain intellectual property protection for our technologies;

●

additions or departures of key personnel;

●

significant lawsuits, including intellectual property or stockholder litigation;

●

if securities or industry analysts do not publish research or reports about us, or if they issue adverse or misleading opinions regarding our business and stock;

●

if large short positions are taken in our stock and or negative reports are provided, whether they are based in fact or otherwise;

●

changes in the market valuations of similar companies;

●

general market or macroeconomic conditions;

●

sales of our common stock by us or our stockholders in the future;

●

trading volume of our common stock;

●

adverse publicity relating to our markets generally, including with respect to other products and potential products in such markets;

●

changes in the structure of health care payment systems; and

●

period-to-period fluctuations in our financial results.

ITEM 1B.

Unresolved Staff Comments

ITEM 2.

Properties

ITEM 3.

Legal Proceedings

ITEM 4.

Mine Safety Disclosures

ITEM 5.

Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities

ITEM 7.

Management’s Discussion and Analysis of Financial Condition and Results of Operations

●

Objective response (OR = >30% tumor reduction) was seen in 88% (7/8) of patients with ICI naive disease; 4/7 (57%) patients’ responses are ongoing (median 17 months).

●

With ICI resistant patients: PDS01ADC dosing appears to affect response rates, with 5/8 (63%) patients receiving PDS01ADC at 16.8 mcg/kg achieving an OR compared to 1/14 (7%) patients who received PDS01ADC at 8 mcg/kg achieving an OR; 4/6 (67%) patients’ responses are ongoing (median 12 months).

●

Tumor reduction was seen in 45% (10/22) of patients with ICI resistant disease, including patients receiving high or low dose PDS01ADC.

●

In ICI resistant patients treated with high or low dose PDS01ADC, survival outcomes were similar (p=0.96 by Kaplan Meier analysis). At a median of 12 months of follow up 17/22 (77%) of patients were alive.

●

In ICI naïve patients 6/8 (75%) were alive at median 17 months of follow up.

●

Similar OR and survival were seen across all types of HPV16-positive cancers.

●

Preliminary safety data: 13/30 (43%) of patients experienced Grade 3 treatment-related adverse events (AEs), and 2/30 patients (7%) experienced Grade 4 AEs. There were no grade 5 treatment-related AEs.

●

Survival data:  66% (19/29) of HPV16-positive ICI resistant patients in the cohort were alive at a median follow up of 16 months.

●

Safety profile: 48% (24/50) patients experienced Grade 3 treatment-related adverse events (AEs), and 4% (2/50) patients experienced Grade 4 AEs. There were no Grade 5 treatment-related AEs.

●

HPV16-positive ICI naïve patients: 75% (6/8) were alive at a median follow up of 25 months and 38% (3/8) of responders had a complete response.

●

Median OS was 21 months in 29 checkpoint inhibitor resistant patients who received the triple combination. The reported historical median OS in patients with ICI resistant disease is 3-4 months seen with checkpoint inhibitors and best reported median survival to date with systemic therapy of 8.2 months in ICI resistant head and neck cancer.

●

In ICI naïve subjects, 75% remain alive at a median follow-up of 27 months.  As a result, median OS had not yet been reached. Historically median OS for similar patients with platinum experienced ICI naïve disease is 7-11 months.

●

Objective response rate (ORR) in ICI resistant patients who received the optimal dose of the triple combination is 63% (5/8).  In current approaches ORR is reported to be less than 10%.

●

ORR in ICI naïve patients with the triple combination is 88%. In current approaches ORR is reported to be less than 25% with FDA-approved ICIs in HPV-positive cancers.

●

Safety data had not changed since October’s update. 48% (24/50) of patients experienced Grade 3 (moderate) treatment-related adverse events (AEs), and 4% (2/50) patients experienced Grade 4 (severe) AEs, compared with approximately 70% of patients receiving the combination of ICIs and chemotherapy reporting Grade 3 and higher treatment-related AEs..

●

Confirmed and unconfirmed response rates thus far (tumor shrinkage greater than 30%) seen in 7/17 (41.2%) patients in comparison to the published results of approximately 19% for approved ICIs, used as monotherapy for recurrent or metastatic head and neck cancer, with 2 of the 7 having complete responses (CR)

●

Stable disease (SD) was reported in 6/17 (35.3%) patients, with 4 of the 6 (67%) experiencing tumor shrinkage of less than 30%

●

Clinical efficacy (ORR + SD) was seen in 13/17 (76.5%) patients

●

Progressive/ongoing disease was reported in 4/17 (23.5%) patients

●

Patients had received a median of 4/5 doses of PDS0101 (range 1-5) and 9/35 doses of Keytruda® (range 1-18)

●

There were no treatment-related adverse events greater than or equal to Grade 3 (N=19)

●

No patients required dose interruption or reduction on the combination treatment

●

No patients discontinued the combination treatment

●

At 9 months of follow up (median not yet achieved):

●

Progression free survival (PFS) rate was 55.2%

●

Overall survival (OS) rate was 87.2%

●

no control or comparative studies have been conducted between ICIs and PDS0101

●

Estimated 12-month overall survival rate was 87.1%. Published results are 36-50% with approved ICIs used alone.

●

Median progression-free survival was 10.4 months (95% CI 4.2, 15.3). Published results are median PFS of 2-3 months for approved ICIs when used as monotherapy in patients with similar PD-L1 levels.

●

A disease control rate (disease stabilization or tumor shrinkage) of 70.6% (24/34)

●

Confirmed and unconfirmed objective response rate is 41.2% (14/34 patients), which is identical to the preliminary response rate data PDS Biotech previously reported at ASCO 2022 (7/17 patients). To date these responses have been confirmed in nine of the 34 patients (26.5%), including one complete response.

●

15/34 patients (44.1%) had stable disease.

●

9/34 patients (26.5%) had progressive disease.

●

4/48 (8.3%) of patients had a Grade 3 treatment-related adverse event (TRAE). No Grade 4 or higher TRAEs were observed.

●

9 of the 17 patients had completed a Day 170 post-treatment Positron Emission Tomography, Computed Tomography (PET CT) scan to assess the status of the cancer. This included 78% (7/9) of treated patients with advanced cervical cancer (FIGO stage III or IV).

●

100% (9/9) of patients treated with the combination of PDS0101 and CRT had an objective response.

●

89% (8/9) of patients treated with the combination of PDS0101 and CRT demonstrated a complete response (CR) on Day 170 by PET CT. One patient who received 3 of the 5 scheduled doses of PDS0101 showed signs of residual disease. One patient who had a CR died from an event unrelated to either their underlying disease or treatment.

●

1-year disease-free survival and 1-year overall survival of 89% (8/9) in patients treated with the combination of PDS0101 and CRT.

●

As previously reported, data confirm PDS0101 treatment activates HPV16-specific CD8 T cells. This increase was not seen in patients who did not receive PDS0101. The increase in HPV16-specific T cells generated by the treatment is positively correlated with tumor cell death, suggesting cytotoxic CD8 T cells are important mediators of antigen-specific immunity.

●

The data affirms that PDS0101 activates Type 1 interferon pathway in humans, mimicking the mechanism previously demonstrated in preclinical studies in animal models.

●

Toxicity of PDS0101 remains limited to low-grade local injection site reactions.

●

the timing and costs of our planned clinical trials;

●

the timing and costs of our planned preclinical studies of our Versamune® platform;

●

the outcome, timing and costs of seeking regulatory approvals;

●

the terms and timing of any future collaborations, licensing, consulting or other arrangements that we may enter into;

●

the amount and timing of any payments we may be required to make in connection with the licensing, filing, prosecution, maintenance, defense and enforcement of any patents or patent applications or other intellectual property rights; and

●

the extent to which we license or acquire other products and technologies.

		Year Ended December 31,
		2023				2022
PDS Biotech projects		$	17,610			$	12,468
Clinical consulting			176				378
Cost of license rights			-				10,000
Salaries and other costs			9,977				6,586
Total		$	27,763			$	29,431

		Year Ended December 31,								Increase (Decrease)
		2023				2022				$					%
		(in thousands)
Operating expenses:
Research and development expenses		$	27,763			$	29,431			$	(1,668	)			(6	)%
General and administrative expenses			15,282				12,241				3,041				25	%
Total operating expenses			43,045				41,672				1,373				3	%
Loss from operations			(43,045	)			(41,672	)			(1,373	)			3	%
Interest  income (expense), net			(1,303	)			(381	)			(922	)			242	%
Benefit from income taxes			1,406				1,199				207	)			17	%
Net loss and comprehensive loss		$	(42,942	)		$	(40,855	)		$	(2,087	)			5	%

		Year Ended December 31,
		2023				2022
Net cash used in operating activities		$	(33,636	)		$	(25,710	)
Net cash provided by financing activities			16,376				34,287
Net (decrease) increase in cash and cash equivalents		$	(17,260	)		$	8,577

●

the initiation, progress, timing, costs and results of our planned clinical trials;

●

the effects of health epidemics, pandemics, or outbreaks of infectious diseases, on our business operations, financial condition, results of operations and cash flows;

●

the outcome, timing and cost of meeting regulatory requirements established by the U.S. Food and Drug Administration, or FDA, the European Medicines Agency, or EMA, and other comparable foreign regulatory authorities;

●

the cost of filing, prosecuting, defending and enforcing our patent claims and other intellectual property rights;

●

the cost of defending potential intellectual property disputes, including patent infringement actions brought by third parties against us now or in the future;

●

the effect of competing technological and market developments;

●

the cost of establishing sales, marketing and distribution capabilities in regions where we choose to commercialize our vaccines on our own; and

●

the initiation, progress, timing and results of our commercialization of our vaccine candidates, if approved, for commercial sale.

●

being permitted to provide only two years of audited consolidated financial statements in this Annual Report on Form 10-K, with correspondingly reduced “Management’s Discussion and Analysis of Financial Condition and Results of Operations” disclosure;

●

reduced disclosure obligations regarding executive compensation;

●

not being required to furnish a contractual obligations table in “Management’s Discussion and Analysis of Financial Condition and Results of Operations”; and

●

not being required to furnish a stock performance graph in our annual report.

ITEM 8.

Financial Statements and Supplementary Data

ITEM 9.

Changes in and Disagreements with Accountants on Accounting and Financial Disclosure

ITEM 9A.

Controls and Procedures

ITEM 9B.

Other Information

ITEM 10.

Directors, Executive Officers and Corporate Governance

ITEM 11.

Executive Compensation

ITEM 12.

Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters

ITEM 13.

Certain Relationships and Related Transactions, and Director Independence

ITEM 14.

Principal Accounting Fees and Services

ITEM 15.

Exhibits, Financial Statement Schedules

(1)

Financial Statements:

(2)

Financial Statement Schedules:

(3)

Exhibits:

ITEM 16.

Form 10-K Summary

+	Indicates management contract or compensatory plan.

*	Filed herewith unless otherwise indicated as furnished herewith.

**	Confidential Treatment has been requested with respect to certain portions of this Exhibit. Omitted portions have been filed separately with the Securities and Exchange Commission.

++	Certain portions of this exhibit have been redacted pursuant to Item 601(b)(10)(iv) of Regulation S-K.