Core Viewpoint - PDS Biotechnology (PDSB) is experiencing significant selling pressure, having declined 35.7% over the past four weeks, but is now positioned for a potential trend reversal as it enters oversold territory, with analysts predicting better earnings than previously expected [1] Group 1: Technical Indicators - The Relative Strength Index (RSI) for PDSB is currently at 22.34, indicating that the heavy selling may be exhausting itself, suggesting a possible bounce back towards equilibrium in supply and demand [3] - A stock is generally considered oversold when its RSI falls below 30, which can signal potential entry opportunities for investors looking to benefit from a rebound [2] Group 2: Fundamental Analysis - There is strong consensus among sell-side analysts to raise earnings estimates for PDSB, with a 4.9% increase in the consensus EPS estimate over the last 30 days, which typically correlates with price appreciation [4] - PDSB holds a Zacks Rank 2 (Buy), placing it in the top 20% of over 4,000 ranked stocks based on earnings estimate revisions and EPS surprises, further indicating a potential turnaround [4]

Clinical Trial Results - The combination of Versamune®HPV and PDS01ADC resulted in a median overall survival of approximately 20 months in a Phase 2 trial for ICI resistant patients, compared to historical median survival of 3-4 months[93]. - In November 2023, updated survival data showed a 75% survival rate at 36 months for ICI naïve patients in the NCI-led Phase 2 trial involving Versamune®HPV, PDS01ADC, and an investigational immune checkpoint inhibitor[100]. - The VERSATILE-002 Phase 2 clinical trial has completed enrollment for both ICI naïve and ICI resistant arms, evaluating the efficacy and safety of Versamune®HPV in combination with Keytruda®[102]. - The company presented data at the 2023 American Society of Clinical Oncology showing a 41.2% confirmed and unconfirmed response rate in patients treated with Versamune®HPV and Keytruda®, compared to approximately 19% for approved ICIs[106]. - The estimated 12-month overall survival rate for the ICI naïve cohort was 87.1%, compared to published results of 36-50% for approved ICIs used alone[110]. - The median progression-free survival (PFS) for the ICI naïve cohort was 10.4 months, while published results for approved ICIs as monotherapy are 2-3 months[110]. - The confirmed overall response rate (ORR) for the ICI naïve cohort was 41.2%, with 26.5% of patients having confirmed responses[110]. - The 24-month overall survival rate for the combination of Versamune® HPV and Keytruda® was 74%, significantly higher than the published rate of less than 30% for approved ICIs[112]. - The median overall survival for the ICI naïve cohort with CPS > 1 was 30 months, compared to published results for ICIs of 7-18 months[113]. - The confirmed overall response rate (ORR) for the ICI naïve cohort was 34%, exceeding the published results of less than 20% for comparable patients receiving ICIs[113]. - The median overall survival (mOS) was reported as 30 months, with a lower 95% confidence interval of 19.7 months, while published mOS for pembrolizumab is 12-18 months[118]. - The disease control rate (DCR) was 77%, with 21% of patients experiencing deep tumor responses and shrinkage of 90-100%[118]. - The company announced a two-part registrational trial focused on the double combination of Versamune® HPV and pembrolizumab for first-line treatment in HPV16-positive recurrent/metastatic HNSCC[114]. - The company plans to initiate a registrational study in first-line treatment in HPV16-positive recurrent/metastatic HNSCC with the double combination of Versamune® HPV and pembrolizumab[116]. - 100% of patients treated with Versamune® HPV and CRT had an objective response, and 89% demonstrated a complete response on Day 170[127]. - The combination of Versamune® HPV and CRT resulted in 81.3% ctDNA clearance after 3 weeks compared to 30.3% with SOC CRT alone (p=0.0018)[128]. - 91.7% ctDNA clearance was observed at 5 weeks with Versamune® HPV plus CRT versus 53.1% with SOC (p=0.0179)[128]. Financial Performance - The company reported net losses of $29.7 million and $32.0 million for the nine months ended September 30, 2024 and 2023, respectively[145]. - As of September 30, 2024, the company had $49.8 million in cash and cash equivalents[147]. - The company has never generated revenues from commercial product sales and does not expect to do so in the near future[148]. - Research and development expenses are expected to increase significantly as the company advances its clinical candidates through trials and regulatory approvals[150]. - Research and development expenses increased to $6.8 million for Q3 2024, up from $6.4 million in Q3 2023, representing a 6% increase[154]. - General and administrative expenses decreased to $3.4 million for Q3 2024, down from $4.1 million in Q3 2023, reflecting a 17% decrease[155]. - Total operating expenses for Q3 2024 were $10.2 million, a decrease of 3% from $10.5 million in Q3 2023[153]. - For the nine months ended September 30, 2024, research and development expenses decreased to $18.0 million, down 11% from $20.3 million in the same period of 2023[157]. - General and administrative expenses for the nine months ended September 30, 2024, were $10.9 million, a decrease of 11% from $12.3 million in the same period of 2023[159]. - The net loss for Q3 2024 was $10.7 million, a slight improvement from a net loss of $10.8 million in Q3 2023[153]. - The company sold 3,428,681 shares of common stock with a net value of $19.4 million during the nine months ended September 30, 2024[162]. - Interest expense increased to $1.6 million for the nine months ended September 30, 2024, up 93% from $0.8 million in the same period of 2023[156]. - Net cash used in operating activities increased to $26.8 million for the nine months ended September 30, 2024, compared to $25.2 million in the same period of 2023, reflecting a $1.6 million increase primarily due to accounts payable and accrued expenses[176]. - Net cash used in investing activities was $29.0 thousand for the nine months ended September 30, 2024, compared to $0 in the same period of 2023[177]. - Net cash provided by financing activities was $20.0 million for the nine months ended September 30, 2024, up from $5.6 million in the same period of 2023, primarily from the sale of common stock[178]. - The company has not generated any product revenue to date and does not expect to do so until regulatory approval and commercialization of product candidates are achieved[179]. - The company anticipates continued losses as it develops and seeks regulatory approvals for its product candidates, with expected increases in losses as operations continue[179]. - There is substantial doubt about the company's ability to continue as a going concern for at least 12 months from the issuance of the financial statements due to reliance on available financial resources[180]. - The company plans to finance its cash needs through equity or debt financings, collaborations, or strategic alliances, but there is no assurance that financing will be available on acceptable terms[180]. - The company has no material non-cancelable purchase commitments with service providers, operating on a cancelable purchase order basis[183]. - The company is exposed to interest rate risk due to a floating interest rate under its Loan and Security Agreement, but historical fluctuations in interest rates have not materially impacted its operations[190]. - Inflation has not had a material effect on the company's business, financial condition, or results of operations during the three months ended September 30, 2024[191]. Product Development and Pipeline - The proprietary combination of Versamune®HPV and PDS01ADC is designed to enhance T cell proliferation and longevity in the tumor microenvironment, addressing limitations of current therapies[93]. - The company executed an exclusive global license agreement with Merck KGaA for the tumor targeting IL-12 fused antibody drug conjugate, M9241, now known as PDS01ADC, in December 2022[93]. - In February 2023, the company completed a Type B meeting with the FDA regarding the clinical protocol for a potential registrational trial for the triple combination therapy[94]. - The investigational universal flu vaccine, PDS0202, demonstrated broad neutralization across multiple influenza strains, providing protection in animal studies presented in September 2023[95]. - The company has a growing pipeline of targeted cancer and infectious disease immunotherapies based on its Versamune® T cell activator technology[91]. - Interim data showed a decrease in PSA levels in all patients treated with PDS01ADC, with 61% experiencing at least a 60% decrease[137]. - The company is exploring the use of PDS01ADC in combination with other Versamune® based clinical candidates[139].

Financial Data and Key Metrics Changes - The net loss for Q3 2024 was approximately $10.7 million, or $0.29 per share, compared to a net loss of $10.8 million, or $0.35 per share in Q3 2023, primarily due to lower operating expenses [25][26] - Research and development expenses increased to approximately $6.8 million in Q3 2024 from $6.4 million in Q3 2023, attributed to higher manufacturing expenses [26] - General administrative expenses decreased to approximately $3.4 million in Q3 2024 from $4.1 million in Q3 2023, mainly due to lower personnel costs and professional fees [27] - Cash and cash equivalents totaled approximately $50 million as of September 30, 2024 [28] Business Line Data and Key Metrics Changes - The VERSATILE-003 trial design was updated to include approximately 350 patients, maintaining statistical power and a 2 to 1 randomization, with median overall survival as the primary endpoint [8][21] - The VERSATILE-002 study showed median overall survival remained at 30 months, with an objective response rate improving from 26% to 36% [10][11] Market Data and Key Metrics Changes - The population of HPV 16-positive patients is increasing significantly, with over 70% of new patients seen by key opinion leaders being HPV 16 positive [16][36] - Most HPV positive patients do not meet the inclusion criteria for the KEYNOTE-689 study, indicating that the potential use of Keytruda in early treatment will not significantly impact the target population for VERSATILE-003 [17][19] Company Strategy and Development Direction - The company aims to be the first to market an HPV-targeted immunotherapy for head and neck cancer, with a focus on the growing population of HPV 16-positive patients [13][21] - The company is exploring the next steps in the development of Versamune HPV for cervical cancer following promising data from the IMMUNOCERV Phase 2 trial [22][23] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the updated trial design for VERSATILE-003 and the potential for timely enrollment, with an FDA decision expected by mid-December [8][63] - The company believes that the increasing incidence of HPV 16-positive head and neck cancer presents a significant long-term opportunity [36][64] Other Important Information - The company is conducting an independent survey of oncologists to understand the treatment landscape and the impact of emerging therapies on their target population [15][16] - The company plans to initiate the VERSATILE-003 trial in early 2025, with a focus on a targeted subset of sites financed from existing resources [21][63] Q&A Session Summary Question: When would the company expect an interim look at the VERSATILE-003 data and thoughts on the opportunity given the changing landscape? - Management indicated that the enrollment duration is expected to be around 18 months, with the first interim data readout anticipated about six months after enrollment completion [39][41] Question: Plans for a Phase 3 trial for IMMUNOCERV and positioning against Merus EGFR bispecific? - Management highlighted the impressive data from Merus but emphasized that their focus is specifically on HPV 16-positive head and neck cancer, which is a rapidly growing population [44][45] Question: Status of the VERSATILE-003 trial arm with PDS01ADC? - Management confirmed that the focus is currently on getting VERSATILE-003 up and running, with plans for dose optimization of PDS01ADC to follow [61][62]

Financial Performance - Reported net loss for Q3 2024 was approximately $10.7 million, or $0.29 per share, compared to a net loss of $10.8 million, or $0.35 per share in Q3 2023[7]. - General and administrative expenses decreased to approximately $3.4 million in Q3 2024 from $4.1 million in Q3 2023, mainly due to lower personnel costs[9]. - Total operating expenses decreased to approximately $10.2 million in Q3 2024 from $10.5 million in Q3 2023[10]. - The company reported a decrease in total stockholders' equity to approximately $22.0 million as of September 30, 2024, from $26.1 million at the end of 2023[15]. - Long-term debt decreased to approximately $12.0 million as of September 30, 2024, from $19.5 million at the end of 2023[15]. Research and Development - Research and development expenses increased to approximately $6.8 million in Q3 2024 from $6.4 million in Q3 2023, primarily due to higher manufacturing expenses[8]. - The updated VERSATILE-003 trial design will include approximately 350 patients and aims for earlier interim readouts and reduced execution costs[4]. - The IMMUNOCERV Phase 2 trial data presented at ASTRO showed promising clinical activity and a compelling safety profile for Versamune® HPV[3]. Regulatory and Future Plans - The company plans to submit an updated IND application to the FDA, expecting clearance by mid-December 2024[2]. - Cash and cash equivalents as of September 30, 2024, totaled approximately $49.8 million, down from $56.6 million at the end of 2023[15].

Core Viewpoint - PDS Biotechnology (PDSB) has received a Zacks Rank 1 (Strong Buy) upgrade, indicating a positive outlook on its earnings estimates, which is a significant factor influencing stock prices [1][2]. Earnings Outlook - The Zacks rating upgrade reflects optimism regarding PDS Biotechnology's earnings outlook, which is expected to create buying pressure and potentially increase its stock price [2]. - For the fiscal year ending December 2024, PDS Biotechnology is projected to earn -$1.24 per share, representing a 10.8% change from the previous year's reported figure [5]. Earnings Estimate Revisions - Analysts have consistently raised their earnings estimates for PDS Biotechnology, with the Zacks Consensus Estimate increasing by 15.4% over the past three months [5]. - The correlation between earnings estimate revisions and near-term stock movements is strong, suggesting that tracking these revisions can be beneficial for investment decisions [4]. Zacks Rank System - The Zacks Rank system classifies stocks into five groups based on earnings estimates, with Zacks Rank 1 stocks historically generating an average annual return of +25% since 1988 [4]. - PDS Biotechnology's upgrade to Zacks Rank 1 places it in the top 5% of Zacks-covered stocks, indicating a strong potential for market-beating returns in the near term [6].

Clinical Trial Results and Efficacy - The company's Versamune® and PDS01ADC combination showed a median overall survival of approximately 20 months in a Phase 2 trial for ICI-resistant HPV-positive cancers, compared to historical median survival of 3-4 months with ICIs and 8.2 months with systemic therapy[78] - 75% survival rate at 36 months was observed in ICI-naïve patients treated with the triple combination of PDS0101, PDS01ADC, and an investigational ICI in a Phase 2 trial[83] - The VERSATILE-002 Phase 2 trial reported a 41.2% response rate (tumor shrinkage >30%) in 7/17 patients treated with PDS0101 and Keytruda®, compared to 19% with ICI monotherapy[88] - Clinical efficacy (ORR + stable disease) was observed in 76.5% of patients (13/17) in the VERSATILE-002 trial, with a progression-free survival rate of 55.2% and overall survival rate of 87.2% at 9 months[88] - Interim data from the VERSATILE-002 trial showed a rapid decline in ctHPV-DNA, a potential predictive biomarker, in patients treated with PDS0101 and standard-of-care chemoradiotherapy[81] - Estimated 12-month overall survival rate was 87.1% for PDS0101 and pembrolizumab in HPV16-positive HNSCC, compared to 36-50% with approved ICIs alone[90] - Median progression-free survival was 10.4 months for PDS0101 and pembrolizumab, compared to 2-3 months with approved ICIs[90] - Disease control rate of 70.6% (24/34) and confirmed objective response rate of 41.2% (14/34) for PDS0101 and pembrolizumab[91] - 24-month overall survival rate of 74% for PDS0101 and pembrolizumab, compared to less than 30% with approved ICIs[93] - Tumor shrinkage seen in 60% (31/52) of patients treated with PDS0101 and pembrolizumab[93] - Median overall survival of 30 months for PDS0101 and pembrolizumab, compared to 7-18 months with ICIs[94] - Confirmed overall response rate of 34% (18/53) for PDS0101 and pembrolizumab, compared to less than 20% with ICIs[94] - Objective response rate of 88% (7/8) for PDS0101, PDS01ADC, and bintrafusp alfa in ICI-naive patients[100] - Median overall survival of 21 months for PDS0101, PDS01ADC, and bintrafusp alfa in ICI-resistant patients, compared to 3-4 months with ICIs[103] - 75% of ICI-naive patients remain alive at 36 months with PDS0101, PDS01ADC, and bintrafusp alfa, compared to 7-11 months with ICIs[104] - PDS0101 combined with chemoradiotherapy showed 81.3% ctDNA clearance after 3 weeks vs. 30.3% with SOC alone (p=0.0018), and 91.7% clearance at 5 weeks vs. 53.1% with SOC (p=0.0179)[107] Regulatory and Trial Progress - The company completed enrollment in the ICI-naïve arm of the VERSATILE-002 trial in May 2023 and received FDA feedback on the amended IND in October 2023[89] - The company confirmed the required contents of a clinical protocol for a potential registrational trial for the triple combination of PDS0101, PDS01ADC, and an FDA-approved ICI in February 2023[79] - The combination of PDS0101 and Keytruda® received Fast Track designation from the FDA in June 2022[88] - PDS0101 monotherapy and in combination with Keytruda® trial initiated in February 2022 for HPV-positive oropharyngeal cancer at Mayo Clinic[107] - PDS0103, targeting MUC1-associated cancers, is in tech transfer and clinical scale-up, with IND submission planned by end of 2024[110][111] Preclinical Studies and Vaccine Development - PDS0202, the company's universal flu vaccine candidate, demonstrated broad neutralization across multiple influenza strains and provided protection against lethal doses of H1N1 in preclinical studies[81] - PDS0102 preclinical studies demonstrated induction of tumor-targeted killer T cells for TARP-associated cancers including AML, prostate, and breast cancer[109] - Infectimune® preclinical data demonstrated complete protection against SARS-CoV-2 and influenza, with enhanced CD4 T cell responses[119] Financial Performance and Expenses - Net losses were $18.9 million for the six months ended June 30, 2024, with an accumulated deficit of $163.4 million[120] - Cash and cash equivalents stood at $57.7 million as of June 30, 2024[120] - Research and development expenses decreased by 43% to $4.5 million for the three months ended June 30, 2024[126][127] - Total operating expenses decreased by 32% to $8.7 million for the three months ended June 30, 2024[127] - General and administrative expenses decreased to $4.2 million for Q2 2024, down from $4.7 million in Q2 2023, primarily due to a $0.3 million decrease in personnel costs and a $0.2 million decrease in professional fees[129] - Income tax benefit decreased to $0.9 million for Q2 2024 from $1.4 million in Q2 2023, driven by a reduction in New Jersey NOL carryforwards sold[130] - Research and development expenses decreased by 19% to $11.2 million for the six months ended June 30, 2024, compared to $13.8 million in the same period in 2023, primarily due to reduced clinical studies and manufacturing costs[131][132] - General and administrative expenses decreased by 9% to $7.6 million for the six months ended June 30, 2024, compared to $8.3 million in 2023, driven by lower personnel and legal fees[131][133] - Net loss decreased by 11% to $18.9 million for the six months ended June 30, 2024, compared to $21.2 million in 2023, reflecting reduced operating expenses[131] - The company sold 3,428,681 shares of common stock with a net value of $19.5 million during the six months ended June 30, 2024, under the Sales Agreement[136] - As of June 30, 2024, the company had $57.7 million in cash and cash equivalents, primarily used to fund operating expenses, including research and development[141] - Net cash used in operating activities increased to $18.8 million for the six months ended June 30, 2024, compared to $18.0 million in 2023, driven by a decrease in accounts payable and accrued expenses[145] - Net cash provided by financing activities was $19.998 million for the six months ended June 30, 2024, primarily due to proceeds from the sale of common stock[147][149] Going Concern and Financial Risks - The company concluded that substantial doubt exists about its ability to continue as a going concern for at least 12 months due to uncertainties in securing additional financing[144] - The company has concluded that substantial doubt exists about its ability to continue as a going concern for at least 12 months from the issuance of the unaudited financial statements[151] - The company's future funding requirements depend on factors such as clinical trial progress, regulatory outcomes, and market developments[152] - The company has no material non-cancelable purchase commitments with service providers[154] - The company's cash equivalents as of June 30, 2024, consist of bank deposits and money market accounts, with exposure to interest rate risk[160] - The company does not believe inflation has had a material effect on its business, financial condition, or results of operations for the quarter ended June 30, 2024[161] Internal Controls and Reporting - The company's disclosure controls and procedures are effective as of the end of the reporting period[164] - There were no changes in the company's internal control over financial reporting during the quarter ended June 30, 2024[165] - The company remains a "smaller reporting company" and intends to rely on certain disclosure exemptions[159]

Exhibit 99.1 PDS Biotech Provides Business Update and Reports Second Quarter 2024 Financial Results PRINCETON, N.J., August 13, 2024 -- PDS Biotechnology Corporation (Nasdaq: PDSB) ("PDS Biotech" or the "Company"), a latestage immunotherapy company focused on transforming how the immune system targets and kills cancers and the development of infectious disease vaccines, today provided a business update and reported financial results for the second quarter of 2024. "We are exiting the second quarter with mom ...

PRINCETON, N.J., Aug. 05, 2024 (GLOBE NEWSWIRE) -- PDS Biotechnology Corporation (NASDAQ:PDSB) ("PDS Biotech" or the "Company"), a late-stage immunotherapy company focused on transforming how the immune system targets and kills cancers and the development of infectious disease vaccines, today announced that an abstract presenting updated data from the VERSATILE-002 trial evaluating first-line treatment with Versamune® HPV (formerly PDS0101) in combination with KEYTRUDA® (pembrolizumab) in patients with HPV1 ...

PDS Biotechnology Corporation (NASDAQ:PDSB) Clinical Program Update Conference Call August 1, 2024 8:00 AM ET Company Participants Mike Moyer - LifeSci Advisors Frank Bedu-Addo - Chief Executive Officer Kirk Shepard - Chief Medical Officer Conference Call Participants Louise Chen - Cantor Fitzgerald Mayank Mamtani - B. Riley Securities Joseph Pantginis - H. C. Wainwright & Co. Operator Greetings, and welcome to PDS Bio Clinical Programs Update Call. At this time all participants are in a listen-only mode. A ...

Company to initiate Phase 3 VERSATILE-003 trial in Q4 2024 Conference Call Today at 8:00 a.m. Eastern Time PRINCETON, N.J., Aug. 01, 2024 (GLOBE NEWSWIRE) -- PDS Biotechnology Corporation (NASDAQ:PDSB) ("PDS Biotech" or the "Company"), a late-stage immunotherapy company focused on transforming how the immune system targets and kills cancers and the development of infectious disease vaccines, today announced that it has received the official minutes from its meeting with the U.S. Food and Drug Administration ...