On August 12, 2025 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, reported a business update and announced financial results for the second quarter ended June 30, 2025 (Press release, PDS Biotechnology, AUG 12, 2025, View Source [SID1234655161]).

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"Our second quarter of 2025 and recent weeks have been a productive period for PDS Biotech, highlighted by the continued progress in our VERSATILE-003 Phase 3 clinical trial evaluating PDS0101 (Versamune HPV) in HPV16-positive recurrent/metastatic ("R/M") head and neck squamous cell carcinoma ("HNSCC"). Highlights also included the announcement and presentation of data from our VERSATILE-002 trial which we believe demonstrates the potential durable clinical benefit of PDS0101," said Frank Bedu-Addo, Ph.D., President and Chief Executive Officer of PDS Biotech. "We look forward to publishing the full data set for this trial later this year, as we continue to progress our VERSATILE-003 trial, the only registrational stage trial specifically targeting HPV16-positive HNSCC patients."

Clinical and Corporate Update

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Announced Colorectal Cancer Cohort of Phase 2 Clinical Trial with PDS01ADC. Met Criteria for Expansion to Stage 2 Following Positive Stage 1 Results

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Metastatic colorectal cancer cohort in study led by the National Cancer Institute demonstrated promising response rate (≥6 of 9 confirmed objective responses by RECIST v1.1), triggering enrollment expansion under Simon Two-Stage design

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Three abstracts on PDS0101 (Versamune HPV) were presented at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting, highlighting updated positive data from the VERSATILE-002 trial, and additional trials evaluating PDS0101 to treat head and neck cancers

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On May 8, 2025, the Company announced preclinical immune response data with a novel Infectimune based universal flu vaccine were featured in two presentations on universal influenza vaccines, including an oral symposium at the American Association of Immunologists’ IMMUNOLOGY2025 Annual Meeting.

Second Quarter 2025 Financial Results

Reported net loss was $9.4 million, or $0.21 per basic and diluted share, for the three months ended June 30, 2025, compared to $8.3 million, or $0.23 per basic share and diluted share, for the three months ended June 30, 2024. The increase in net loss was primarily due to higher net interest expenses, partially offset by lower personnel costs.

Research and development expenses were $4.2 million for the three months ended June 30, 2025, compared to $4.5 million for the three months ended June 30, 2024. The decrease was primarily due to lower personnel costs, partially offset by higher manufacturing costs.

General and administrative expenses were $3.4 million, for the three months ended June 30, 2025, compared to $4.2 million for the three months ended June 30, 2024. The decrease was primarily due to lower personnel costs and lower professional fees.

Total operating expenses were $7.6 million for the three months ended June 30, 2025, compared to $8.7 million for the three months ended June 30, 2024.

Net interest expenses were $1.8 million for the three months ended June 30, 2025, compared to $0.5 million for the three months ended June 30, 2024. The increase was primarily due to debt repayment costs.

The Company’s cash balance as of June 30, 2025 was $31.9 million, compared to $41.7 million as of December 31, 2024.

Conference Call Details

Date: August 13, 2025
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On August 12, 2025 Xspray Pharma reported the company has entered into a license agreement with Handa Therapeutics ("Handa") granting Handa a non-exclusive license to certain Xspray patents (Press release, Xspray, AUG 12, 2025, View Source [SID1234655394]). The license covers commercialization of a dasatinib product in the US market and, at a later stage, selected Asian markets. Under the agreement, Xspray will receive up to a double-digit royalty on Handa’s net proceeds.

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This is the first out-licensing from Xspray’s broad patent portfolio and marks an important milestone in capitalizing on its intellectual property assets. The company’s core strategy to develop and commercialize improved PKI-drugs using its patented HyNap technology remains unchanged. Its lead product candidate Dasynoc awaits FDA-approval with a PDUFA date of October 7, 2025. However, further licensing agreements may be considered on a case-by-case basis.

"The agreement confirms the value of our patent portfolio and demonstrates that our long-term work to build our comprehensive patent portfolio is paying off. As for the dasatinib market, I’m convinced that when Dasynoc is launched it will be seen as the premium product in its market segment as it combines pH-independent absorption with lower dose strength and high precision, eliminating sensitivity to all acid-reducing agents." says Per Andersson, CEO of Xspray Pharma.

The agreement further ensures that Xspray’s planned launch of Dasynoc can proceed without being affected by any United States regulatory exclusivities that may be associated with Handa’s product. Handa’s dasatinib product has not yet been launched.

On August 12, 2025 Bayer and Kumquat Biosciences Inc., a clinical-stage biotech company founded by pioneers of the KRAS pathway, reported that they have entered into an exclusive global license and collaboration to develop and commercialize Kumquat’s KRAS G12D inhibitor (Press release, Kumquat Biosciences, AUG 12, 2025, View Source [SID1234655142]). Under the agreement, Kumquat is responsible for the initiation and completion of the Phase Ia study, while Bayer will complete development and commercial activities.

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Kumquat received U.S. Food and Drug Administration (FDA) clearance of the investigational new drug (IND) for its KRAS G12D inhibitor in July 2025. Under the terms of the agreement, Kumquat will receive up to $1.3 billion, including upfront, clinical and commercial milestones, and additional tiered royalties on net sales. Kumquat retains an exclusive option to negotiate for participating in profit-loss sharing in the US.

"We are constantly evaluating innovative approaches to improve outcomes for patients, focusing on areas of high unmet medical need," said Juergen Eckhardt, M.D., Head of Business Development and Licensing at Bayer’s Pharmaceuticals Division. "We look forward to collaborating with Kumquat, an accomplished team of experts with deep KRAS insights. Our intent is to explore the development of a potential new treatment option for patients, while further complementing Bayer’s robust early precision oncology pipeline."

Oncogenic driver mutations, such as KRAS mutations, are changes in the DNA of genes that drive the development and growth of cancer. These mutations are often identified as key targets for cancer treatment, and their identification offers the opportunity to develop target-specific drugs. KRAS G12D mutations are found most frequently in 37 percent of pancreatic ductal adenocarcinoma (PDAC), 13 percent of colorectal cancer and 4 percent of non-small cell lung cancers. PDAC is the most common type of pancreatic cancer (accounting for 85 percent of cases) and remains one of the most difficult tumors to treat, with patients having few treatment options beyond chemotherapy and the five-year survival rate being less than 10 percent. Pancreatic cancer is the sixth leading cause of cancer-related death worldwide. The incidence continues to rise annually, with projections indicating a 95.4 percent increase in new cases by 2050, potentially reaching a total of 998,663 new cases globally.4

"KRAS mutations are crucial for cancer development and can be targeted with specific therapies in a more selective manner," said Dominik Ruettinger, M.D., Ph.D., Global Head of Research and Early Development for Oncology at Bayer’s Pharmaceuticals Division. "KRAS mutations occur in nearly 25 percent of human cancers, yet the most prevalent and oncogenic KRAS (G12D) variant still lacks effective treatment options. We look forward to exploring the investigational KRAS G12D inhibitor, which targets a highly relevant signaling pathway that promotes tumor growth and survival."

"Since pioneering the direct targeting of KRAS G12C mutation over a decade ago, we have continued to discover innovative strategies to target other KRAS mutants, including KRAS G12D," said Yi Liu, Chief Executive Officer of Kumquat. "Advancing our novel KRAS G12D asset into the clinic reflects our commitment to delivering durable therapies for KRAS patients suffering from deadly malignancies such as pancreatic, lung and colorectal cancers. This collaboration with Bayer validates the strength of our platform and the potential of our KRAS G12D candidate to address long-standing unmet needs in oncology. We are thrilled to collaborate with Bayer, who shares our vision and strategy for realizing the benefit of small molecule-based transformative treatments. While advancing optimally our KRAS G12D program through the clinic, this collaboration provides Kumquat the financial resources to accelerate its broader clinical pipeline for long-term value, and position Kumquat to deliver life-changing medicines and achieve sustained growth in the coming years."

On August 12, 2025 SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) ("SELLAS’’ or the "Company"), a late-stage clinical biopharmaceutical company focused on the development of novel therapies for a broad range of cancer indications, reported financial results for the second quarter ended June 30, 2025, and provided a corporate update (Press release, Sellas Life Sciences, AUG 12, 2025, View Source [SID1234655162]).

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"We continue to make significant progress in advancing our AML-focused pipeline, as demonstrated by the positive Phase 2 results evaluating our novel CDK9 inhibitor, SLS009, for the treatment of r/r AML," said Angelos Stergiou, MD, ScD h.c., President and Chief Executive Officer of SELLAS. "The Phase 2 trial met all primary endpoints, achieving a 44% response rate among patients with Acute Myeloid Leukemia-Myelodysplasia-Related Changes (AML-MRC), which at the optimal dose level, nearly tripled the median overall survival compared to a historical benchmark. Based on the strength of these data, we conducted an end-of-Phase 2 meeting and the FDA recommended advancing SLS009 into the front-line setting for AML. We are now preparing an 80-patient trial that is focused on newly diagnosed and early refractory to venetoclax and azacitidine AML patients, with enrollment anticipated to begin by Q1 2026."

Dr. Stergiou continued, "During the quarter, we also presented promising preclinical data at ASCO (Free ASCO Whitepaper) supporting SLS009 as a potential targeted therapy for ASXL1 mutated colorectal cancer and strengthened our scientific leadership with the addition of three world-class oncology experts to our Scientific Advisory Board. With the final pivotal Phase 3 REGAL data of GPS in AML expected by year-end, positive Phase 2 data of SLS009 in r/r AML, and our upcoming ESMO (Free ESMO Whitepaper) presentation showcasing SLS009’s impact in T-PLL, we enter the second half of 2025 with tremendous momentum and a clear focus on advancing our late-stage clinical programs and growing shareholder value."

Recent Corporate Highlights:

Phase 3 REGAL Trial of GPS: On August 7, 2025, SELLAS announced that the IDMC completed a pre-specified analysis of the Phase 3 REGAL trial of GPS in AML and issued a positive recommendation to continue the trial without modification. The IDMC concluded that the risk-benefit profile of GPS supports continued evaluation under the current study protocol. No safety concerns were identified, and available efficacy data were consistent with expectations for continued trial conduct. The final analysis will be conducted once 80 events (deaths) are reached and is anticipated by year-end.

Announced Positive Results from Phase 2 Trial of SLS009 in r/r AML: The trial met all primary endpoints, demonstrating a 44% response rate among patients with Acute Myeloid Leukemia-Myelodysplasia-Related Changes (AML-MRC) at an optimal dose of 30 mg twice weekly and 50% in AML-MRC with myelomonocytic/myelomonoblastic (M4/M5) subtype, significantly exceeding the targeted 20% ORR. In addition, the treatment achieved a median overall survival (mOS) of 8.9 months in AML-MRC patients, while all relapsed or refractory to venetoclax-based regimens patients receiving 30 mg BIW achieved a mOS of 8.8 months, far surpassing the historical benchmark of 2.4 months.

SLS009 End-of-Phase 2 Meeting: The FDA recommended that SELLAS proceed into a trial to include newly diagnosed, first-line AML patients eligible for venetoclax/azacitidine (aza/ven) therapy, where the Agency believes clinical benefit might be greatest. The randomized 80-patient trial is currently in preparation and is expected to begin enrollment by Q1 2026. The FDA indicated a preference for response rate as the primary endpoint. The trial will include two groups: 1) predictive biomarker cohort of newly diagnosed patients unlikely to benefit from standard aza/ven therapy based on molecular profiling, and 2) early resistance cohort of patients who initiate treatment with aza/ven but demonstrate confirmed lack of any response after two treatment cycles. Whether additional patients will be needed – either for broader study expansion or only within one of the study arms – will depend on the outcomes observed in the initial cohorts (n=40 per arm). This study may support a New Drug Application (NDA), including accelerated approval.

Presented Preclinical Efficacy of SLS009 in ASXL1 Mutated Colorectal Cancer at ASCO (Free ASCO Whitepaper) 2025: The presentation demonstrated SLS009’s ability to selectively target ASXL1-driven tumors at concentrations well below the known safety threshold. The ASXL1 mutation status could serve as a potential biomarker for response to SLS009 inhibition, which may allow the Company to further refine patient selection and improve outcomes.

Expanded Scientific Advisory Board: New members, Philip C. Amrein, MD, Alex Kentsis, MD, PhD, and Linghua Wang, MD, PhD, bring decades of expertise in cancer research, clinical oncology, and translational medicine, further strengthening the Company’s strategic guidance as it advances its pipeline.

Announced Inclusion in the Russell 3000 and Russell 2000 Indexes: The Russell 3000 Index tracks the performance of the largest 3,000 publicly traded U.S. companies and serves as a broad benchmark for the U.S. equity market. The Russell 2000 Index, a subset of the Russell 3000, measures the performance of the small-cap stocks and represents approximately 10% of the total market capitalization of the U.S. equity market.

Preclinical Efficacy of SLS009 in T-Cell Prolymphocytic Leukemia (T-PLL) to be Showcased at ESMO (Free ESMO Whitepaper) 2025: The poster, entitled, CDK9 Inhibition Enhances Venetoclax Activity and Prolongs Survival in a T-PLL Patient-Derived Xenograft Model, will be presented during the ESMO (Free ESMO Whitepaper) congress to be held in Berlin, 17-21 October 2025.

Financial Results for the Second Quarter 2025:

R&D Expenses: Research and development expenses for the quarter ended June 30, 2025 were $3.9 million compared to $5.2 million for the same period in 2024. Research and development expenses in the first half of 2025 were $7.1 million compared to $10.3 million for the same period in 2024. The decrease was primarily due to decreases in clinical trial expenses, manufacturing costs and clinical drug supply purchases, and clinical and regulatory consulting costs, which were primarily driven by the completion of enrollment in the REGAL study in the first quarter of 2024.

G&A Expenses: General and administrative expenses for the second quarter of 2025 were $3.0 million compared to $2.4 million for the same period in 2024. The $0.6 million increase was primarily attributable to increases in professional fees, personnel related expenses, including non-cash stock-based compensation, and outside services and public company costs. General and administrative expenses were $5.9 million for the first half of 2025 compared to $7.0 million for the same period in 2024. The $1.1 million decrease was primarily attributable to a decrease in personnel related expenses driven by the initial recognition of a one-time severance charge in the prior period.

Net Loss: The net loss was $6.6 million for the second quarter of 2025, or a basic and diluted loss per share of $0.07, compared to a net loss of $7.5 million for the second quarter of 2024, or a basic and diluted loss per share of $0.13. The net loss was $12.4 million for the first half of 2025, or a basic and diluted net loss per share of $0.13, compared to a net loss of $17.0 million for the first half of 2024, or a basic and diluted net loss per share of $0.33.

Cash Position: As of June 30, 2025, cash and cash equivalents totaled approximately $25.3 million. Subsequent to June 30, 2025, the Company received $4.0 million in proceeds in July 2025 from the exercise of warrants.

On August 12, 2025 TScan Therapeutics, Inc. (Nasdaq: TCRX), a clinical-stage biotechnology company focused on the development of T cell receptor (TCR)-engineered T cell (TCR-T) therapies for the treatment of patients with cancer, reported financial results for the second quarter ended June 30, 2025, and provided a corporate update (Press release, TScan Therapeutics, AUG 12, 2025, View Source [SID1234655163]).

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"We expect to dose our first solid tumor patients with multiplex TCR-T in the third quarter of this year," said Gavin MacBeath, Ph.D., Chief Executive Officer. "We are currently enrolling into three different multiplex cohorts in our PLEXI-T trial and plan to share safety and preliminary response data in the first quarter of 2026. In parallel, we are finalizing our commercial-ready process for our heme program, which results in shorter manufacturing times and substantially lower cost of goods, and look forward to presenting updated data on our ALLOHA study by the end of the year."

Upcoming Anticipated Milestones

Heme Malignancies Program: TScan’s lead TCR-T therapy candidate, TSC-101, is designed to treat residual disease and prevent relapse in patients with acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), or myelodysplastic syndrome (MDS) undergoing allogeneic hematopoietic cell transplantation (HCT) (the ALLOHA trial, NCT05473910).

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Plans to initiate a registrational trial for TSC-101, pending further feedback from regulatory authorities, in the second half of 2025.
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Expects to file an investigational new drug (IND) application for TSC-102-A0301, a TCR-T targeting an HLA-A*03:01-restricted epitope on CD45, in the second half of 2025.
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Plans to present additional data from the ALLOHA Phase 1 trial, including two-year relapse data on the initial patients treated with TSC-101, by the end of the year.

Solid Tumor Program: TScan continues to develop the ImmunoBank, a collection of TCR-T therapy candidates that target different cancer-associated antigens presented on diverse HLA types. TScan’s strategy is to treat patients with multiple TCR-T therapy candidates to overcome tumor heterogeneity and resistance that may arise from either target or HLA loss (the PLEXI-T trial, NCT05973487).

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Expects to dose first patients with multiplex TCR-T in the third quarter of 2025.
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Plans to share initial safety and response data in the first quarter of 2026.

Second Quarter 2025 Financial Results

Revenue: Revenue for the second quarter of 2025 was $3.1 million, compared to $0.5 million for the second quarter of 2024. The increase was primarily due to timing of research activities pursuant to the Company’s collaboration agreement with Amgen.

R&D Expenses: Research and development (R&D) expenses for the second quarter of 2025 were $32.6 million, compared to $26.9 million for the second quarter of 2024. The increase of $5.8 million was primarily driven by an increase in laboratory supplies, research materials and studies expenses due to ongoing activities with a global contract development and manufacturing organization, as well as an increase in facility-related and personnel expenses associated with continued expansion of internal manufacturing capabilities. R&D expenses included non-cash stock compensation expense of $1.7 million and $1.2 million for the second quarter of 2025 and 2024, respectively.

G&A Expenses: General and administrative (G&A) expenses for the second quarter of 2025 were $9.1 million, compared to $7.8 million for the second quarter of 2024. The increase of $1.3 million was primarily driven by an increase in personnel expenses due to increased headcount to support business activities. G&A expenses included non-cash stock compensation expense of $1.6 million and $1.1 million for the second quarter of 2025 and 2024, respectively.

Net Loss: Net loss was $37.0 million for the second quarter of 2025, compared to $31.7 million for the second quarter of 2024, and included net interest income of $1.7 million and $2.5 million, respectively.

Cash Position: Cash, cash equivalents, and marketable securities as of June 30, 2025, were $218.0 million, excluding $5.0 million of restricted cash. The Company believes that its existing cash resources will be sufficient to fund its current operating plan into the first quarter of 2027.

Share Count: As of June 30, 2025, the Company had 56,747,993 shares of common stock outstanding, consisting of 52,471,405 shares of voting common stock and 4,276,588 shares of non-voting common stock. In addition, the Company had 73,087,945 of pre-funded warrants outstanding to purchase shares of voting common stock at an exercise price of $0.0001 per share. Pro forma outstanding shares as of June 30, 2025, inclusive of both common stock and pre-funded warrants, were 129,835,938.