PDS Biotechnology (PDSB) has been on a downward spiral lately with significant selling pressure. After declining 35.7% over the past four weeks, the stock looks well positioned for a trend reversal as it is now in oversold territory and there is strong agreement among Wall Street analysts that the company will report better earnings than they predicted earlier.Guide to Identifying Oversold StocksWe use Relative Strength Index (RSI), one of the most commonly used technical indicators, for spotting whether a ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2024 ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ____________ to _____________ Commission file number 001-37568 PDS Biotechnology Corporation (Exact name of registrant as specified in its charter) Delaware ...

PDS Biotechnology Corporation (NASDAQ:PDSB) Q3 2024 Earnings Conference Call November 14, 2024 8:30 AM ET Company Participants Tom Johnson - LifeSci Advisors Frank Bedu-Addo - Chief Executive Officer Lars Boesgaard - Chief Financial Officer Kirk Shepard - Chief Medical Officer Conference Call Participants Louise Chen - Cantor Fitzgerald Ali Rashidfarrokhi - B. Riley Robert LeBoyer - Noble Capital Markets Operator Good morning ladies and gentlemen and welcome to PDS Biotech's Third Quarter 2024 Results and C ...

Exhibit 99.1 PDS Biotech Provides Clinical Programs Update and Reports Third Quarter 2024 Financial Results Conference call and webcast today at 8:30 a.m. Eastern Time PRINCETON, N.J., November 14, 2024 -- 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 provided a business update and reported financial results for ...

PDS Biotechnology (PDSB) could be a solid addition to your portfolio given its recent upgrade to a Zacks Rank #1 (Strong Buy). This upgrade primarily reflects an upward trend in earnings estimates, which is one of the most powerful forces impacting stock prices.The sole determinant of the Zacks rating is a company's changing earnings picture. The Zacks Consensus Estimate -- the consensus of EPS estimates from the sell-side analysts covering the stock -- for the current and following years is tracked by the ...

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 ...