NHS-IL-12

PRINCETON, N.J., Aug. 13, 2026 (GLOBE NEWSWIRE) -- PDS Biotechnology Corporation (Nasdaq: PDSB) (“PDS Biotech” or the “Company”), a clinical-stage biotechnology company focused on developing targeted immunotherapies for cancer, today provided a business and clinical programs update and reported financial results for the quarter ended June 30, 2026. Clinical and Corporate Update Announced publication of positive clinical and immunological biomarker data from Stage 1 of the NCI-led metastatic colorectal cancer (mCRC) Phase 2, open-label, single-center, non-randomized clinical trial evaluating PDS0301 (formerly PDS01ADC), the Company’s tumor-targeted IL-12 immunocytokine. The clinical trial results, published in the March 2026 issue of the Journal of Clinical Oncology (JCO) Oncology Advances, included: Objective response rate (ORR) by RECIST v1.1: 77.8% (7/9) at six months; in the parallel trial without PDS0301, the ORR was 35% (7/20)24-month survival rate approximately 80%; in the parallel trial without PDS0301, the 24-month survival rate was approximately 35%Extrahepatic progression-free survival (PFS): median not reached at minimum follow-up of 13.1 months; in the parallel trial without PDS0301, the PFS was 8.1 months On August 11, 2026, the Company issued a shareholder letter outlining its strategic refocus to prioritize PDS0301, its tumor-targeted IL-12 immunocytokine, as its lead development program. As part of this strategy, the Company will cease further internal investment in PDS0101, including the discontinuation of the VERSATILE-003 Phase 3 trial, and intends to pursue strategic partnerships or other externally funded opportunities for the continued development of PDS0101. The Company believes that concentrating its capital and development resources on PDS0301, while maintaining financial discipline and preserving the potential value of PDS0101 through partnerships, may provide the strongest path toward creating long-term value for patients and shareholders. Second Quarter 2026 Financial Results Reported net loss was $9.8 million, or $0.18 per basic and diluted share, for the three months ended June 30, 2026, compared to $9.4 million, or $0.21 per basic and diluted share, for the three months ended June 30, 2025. Research and development expenses were $3.3 million for the three months ended June 30, 2026, compared to $4.2 million for the three months ended June 30, 2025. The decrease was primarily attributable to lower clinical trial costs, manufacturing costs and personnel costs, partially offset by higher stock-based compensation expense. General and administrative expenses were $3.2 million for the three months ended June 30, 2026, compared to $3.4 million for the three months ended June 30, 2025. The decrease was primarily attributable to a decrease in professional fees. Total operating expenses were $6.5 million for the three months ended June 30, 2026, compared to $7.6 million for the three months ended June 30, 2025. Net interest expenses were $3.3 million for the three months ended June 30, 2026, compared to $1.8 million for the three months ended June 30, 2025. The increase was primarily due to a non-cash charge for loss on retirement of debt, partially offset by lower cash interest payments. The Company’s cash balance as of June 30, 2026, was $5.6 million. About PDS Biotechnology PDS Biotechnology is a clinical-stage biotechnology company focused on developing targeted immunotherapies for cancer. Following a strategic review, the Company has prioritized PDS0301, its investigational tumor-targeted interleukin-12 (IL-12) immunocytokine, as its lead development program. PDS0301 is designed to deliver IL-12 preferentially to the tumor microenvironment, with the goal of enhancing anti-tumor immune activity while limiting systemic exposure. PDS0301 has been clinically evaluated across multiple solid tumors, including metastatic colorectal cancer and prostate cancer. The Company is focused on advancing PDS0301 in indications where its tumor-targeted mechanism and potential to modify the tumor microenvironment may complement established and emerging cancer therapies and help address mechanisms of treatment resistance. PDS Biotechnology also owns the Versamune® platform, including PDS0101, which has been evaluated in HPV16-positive cancers. Following its strategic review, the Company decided to prioritize its capital and development resources toward PDS0301 and intends to pursue strategic partnerships or other externally funded opportunities for the continued development of PDS0101. For more information, please visit www.pdsbiotech.com Forward Looking Statements This communication contains forward-looking statements (including within the meaning of Section 21E of the United States Securities Exchange Act of 1934, as amended, and Section 27A of the United States Securities Act of 1933, as amended) concerning PDS Biotechnology Corporation (the “Company”) and other matters. These statements may discuss goals, intentions and expectations as to future plans, trends, events, results of operations or financial condition, or otherwise, based on current beliefs of the Company’s management, as well as assumptions made by, and information currently available to, management. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as “may,” “will,” “should,” “would,” “expect,” “anticipate,” “plan,” “likely,” “believe,” “estimate,” “project,” “intend,” “forecast,” “guidance”, “outlook” and other similar expressions among others. Forward-looking statements are based on current beliefs and assumptions that are subject to risks and uncertainties and are not guarantees of future performance. Actual results could differ materially from those contained in any forward-looking statement as a result of various factors, including, without limitation: the Company’s ability to protect its intellectual property rights; 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; 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; 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; the timing for the Company or its partners to conduct clinical trials for PDS0301 (formerly PDS01ADC), PDS0103 (Versamune® MUC1) and other Versamune® based product candidates; the future success of such trials; the successful implementation of the Company’s research and development programs and collaborations, including any collaboration studies concerning PDS0101, PDS0301, PDS0103 and other Versamune® based product candidates 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; the success, timing and cost of the Company’s or its partners’ ongoing clinical trials and anticipated clinical trials for the Company’s current product candidates, including statements regarding response rates, the timing of initiation, pace of enrollment and completion of the trials (including the Company’s ability to fully fund its disclosed clinical trials, which assumes no material changes to the Company’s currently projected expenses), futility analyses, presentations at conferences and data reported in an abstract, and receipt of interim or preliminary 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; 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 Company’s ability to continue as a going concern; the anticipated benefits of the Company strategic refocus on PDS0301; the Company's ability to identify, negotiate and consummate strategic partnerships or other externally funded opportunities for PDS0101; the Company's ability to preserve, realize or enhance the value of its development programs; the Company's expectations regarding the timing, availability and sufficiency of capital resources to execute its business strategy; and other factors, including legislative, regulatory, political and economic developments not within the Company’s control. The foregoing review of important factors that could cause actual events to differ from expectations should not be construed as exhaustive and should be read in conjunction with statements that are included herein and elsewhere, including the other risks, uncertainties, and other factors described under “Risk Factors,” “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and elsewhere in the documents we file with the U.S. Securities and Exchange Commission. The forward-looking statements are made only as of the date of this press release and, except as required by applicable law, the Company undertakes no obligation to revise or update any forward-looking statement, or to make any other forward-looking statements, whether as a result of new information, future events or otherwise. Versamune® is a registered trademark of PDS Biotechnology Corporation. Investor Contact:Mike MoyerLifeSci AdvisorsPhone +1 (617) 308-4306 Email: mmoyer@lifesciadvisors.com Media Contact:Jude Gorman / Kiki TorpeyCollected StrategiesPDS-CS@collectedstrategies.com PDS BIOTECHNOLOGY CORPORATION AND SUBSIDIARYCondensed Consolidated Statements of Operations and Comprehensive Loss(Unaudited) Three Months Ended June 30, Six Months Ended June 30, 2026 2025 2026 2025 Operating expenses: Research and development expenses $3,265,586 $4,212,918 $6,722,618 $10,043,918 General and administrative expenses 3,231,148 3,410,433 6,295,203 6,685,191 Total operating expenses $6,496,734 $7,623,351 $13,017,821 $16,729,109 Loss from operations $(6,496,734) $(7,623,351) $(13,017,821) $(16,729,109) Interest income (expense) Interest income $125,405 $333,624 $312,219 $711,473 Interest expense (3,379,246) (2,144,481) (4,394,029) (3,075,359)Interest income (expense), net $(3,253,841) $(1,810,857) $(4,081,810) $(2,363,886) Loss before income taxes $(9,750,575) $(9,434,208) $(17,099,631) $(19,092,995)Benefit from income taxes - - - 1,169,820 Net loss and comprehensive loss $(9,750,575) $(9,434,208) $(17,099,631) $(17,923,175) Per share information: Net loss per share, basic and diluted $(0.18) $(0.21) $(0.31) $(0.41)Weighted average common shares outstanding basic and diluted 55,659,669 45,902,502 55,659,669 43,226,618 PDS BIOTECHNOLOGY CORPORATION AND SUBSIDIARYSelected Balance Sheet Data(Unaudited) June 30, December 31, 2026 2025 Cash and cash equivalents $5,596,254 $26,711,969 Working capital $(5,332,283) $18,770,871 Total assets $8,807,213 $30,494,083 Long term debt $- $11,733,350 Accumulated deficit $(233,706,135) $(216,606,504)Total stockholders’ equity $(3,579,739) $9,251,833

01 肿瘤领域资讯 PDS Biotech 公布免疫治疗管线战略调整，优先推进结直肠癌免疫疗法 PDS0301 PDS Biotechnology 宣布战略重心调整，将优先推进肿瘤靶向 IL-12 免疫细胞因子 PDS0301 用于转移性结直肠癌（mCRC）临床开发，同步启动对外合作洽谈。PDS0301 现阶段处于 II 期临床阶段；既往中期数据提示可诱导肿瘤特异性 T 细胞应答。公司决定停止 HPV 疫苗 PDS0101 三期试验内部投入，集中全部资源完成结直肠癌队列临床入组，预计 2027 年上半年读出关键 II 期数据，PDS0101 后续对外寻求合作开发。 Eikon Therapeutics 公布黑色素瘤免疫试验 TeLuRide‑006 独立 DMC 剂量推荐结果 针对晚期黑色素瘤的自适应 II/III 期 TeLuRide‑006 研究，独立数据监查委员会 DMC 完成预设期中分析，正式确定后续试验固定给药剂量 0.60 mg/m²，试验按原计划继续推进。候选药物 EIK1001 为 TLR7/8 双重激动剂，可同时激活髓系、浆细胞样树突状细胞，协同免疫检查点抑制剂；目前晚期黑色素瘤领域，多数联合方案尚未实现总生存统计学获益，该项目希望填补这一未满足临床需求。 02 新药研发与药监审批资讯 英国 MHRA 批准礼来 Foundayo，用于 2 型糖尿病与体重管理，8 月 11 日行业媒体集中报道 英国药品和健康产品管理局 MHRA 于 8 月 10 日授予礼来 Foundayo（orforglipron）上市许可，适应症包含成人 2 型糖尿病血糖控制，以及肥胖 / 超重人群长期体重管理。该分子属于新一代小分子 GLP‑1 受体激动剂；英国成为欧洲首个授予该药物上市许可的地区。监管提示：不用于 1 型糖尿病、糖尿病酮症酸中毒；胰腺炎既往史人群需要谨慎评估使用。 AC Immune 抗 α‑突触核蛋白主动免疫疗法获 FDA 快速通道资格，针对早期帕金森病 候选药物 ACI‑7104 为靶向聚集型 α‑突触核蛋白主动免疫治疗，用于早期帕金森病，获得 FDA 快速通道认定，同时完成美国 IND 申报，II 期 VacSYn 自适应生物标志物临床试验扩展美国多中心入组。中期数据证实具备良好安全性与免疫原性，Part1 队列第 100 周完整结果计划于 2026 下半年对外公布。 03 再生医疗资讯 Sana Biotechnology：媒体综述复盘低免疫异体胰岛细胞 UP421 随访 14 个月临床数据 行业媒体 8 月 11 日综述再次复盘低免疫修饰异体原代胰岛细胞 UP421 既往公布的人体移植数据；受试者在无需长期免疫抑制剂条件下完成移植，随访 14 个月，C‑肽持续可检出，混合餐耐量试验 C‑肽应答维持稳定；PET‑MRI 证实移植部位胰岛细胞持续存活，全程未出现严重安全性事件。同技术平台 iPSC 来源胰岛产品 SC451 计划 2026 递交 IND，目标实现一次性移植长期控糖，摆脱胰岛素与免疫抑制药物。 Kyverna Therapeutics 发布 2026Q2 财报与自身免疫细胞疗法管线更新 企业核心管线为 CD19 靶向 CAR-T 疗法 miv-cel，布局多种自身免疫性疾病；更新全球多中心临床入组进度，重点推进僵人综合征、重症肌无力注册性临床试验，同步开展系统性红斑狼疮、系统性硬化症适应症探索。企业提示，自身免疫 CAR‑T 需要重点关注 B 细胞长期缺失、低丙种球蛋白血症感染风险；多项确证性试验设计正在与 FDA 开展监管沟通。 04 慢病领域资讯 行业媒体转载《Annals of Oncology》大样本真实世界研究：GLP‑1 激动剂降低非糖尿病肥胖人群肥胖相关肿瘤风险 纳入 16 万以上无糖尿病肥胖受试者大型真实世界队列；对比单纯生活方式干预，使用司美格鲁肽、替尔泊肽等 GLP‑1 受体激动剂人群，13 种 NCI 定义肥胖相关恶性肿瘤综合风险下降 41%；子宫内膜癌、结直肠癌风险下降幅度最为突出。研究属于观察性队列，不构成 GLP‑1 药物抗肿瘤新适应症，仅提示相关性，尚需前瞻性干预研究进一步验证因果关系。 Mereo 公布 α1‑抗胰蛋白酶缺乏肺病新药 alvelestat 对外授权协议 口服在研药物 alvelestat 用于 α1‑抗胰蛋白酶缺乏相关肺病（AATD‑LD），Mereo 与 Sentynl Therapeutics 签署选择权与授权协议。行使选择权后 Sentynl 获得美国商业化权益；Mereo 保留全球其余地区权益，双方共同优化 III 期临床方案。α1‑抗胰蛋白酶缺乏为罕见遗传疾病，可进展为肺气肿、慢阻肺，该药物为潜在 first‑in‑class 口服候选。 免责声明 本文资讯均来自公开企业公告、权威行业媒体、期刊公开内容，仅作行业信息交流，不构成诊疗建议、投资建议；临床试验相关数据仍处于研究阶段，药物适应症、安全性以各国药监机构最终审批文件为准。部分研究为观察性研究，相关性不等同因果结论，请理性参考。 关于我们： 盛康和光是专注赴日医疗服务的专业机构，依托集团 20 年对日服务经验，提供海外第二诊疗意见、日本精密体检、肿瘤赴日治疗、再生医疗、全周期健康管理一站式解决方案，以合规透明的服务体系，为国内患者搭建对接日本优质医疗资源的便捷桥梁。每一次诊疗评估，每一趟海外就医安排，每一套健康管理方案，都是我们对患者健康的郑重承诺，愿你被世界温柔以待，也被专业医疗温柔守护。