On August 12, 2025 ORIC Pharmaceuticals, Inc. (Nasdaq: ORIC), a clinical stage oncology company focused on developing treatments that address mechanisms of therapeutic resistance, reported financial results and operational updates for the quarter ended June 30, 2025 (Press release, ORIC Pharmaceuticals, AUG 12, 2025, View Source [SID1234655160]).

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"In the first half of the year, we’ve continued to make steady progress towards the potential initiation of Phase 3 studies in 2026 for ORIC-944 in prostate cancer and ORIC-114 (now enozertinib) in lung cancer, and we were pleased to further strengthen our cash position and runway with recent financing activity," stated Jacob M. Chacko, M.D., president and chief executive officer. "As our clinical programs have progressed closer to registrational studies, it necessitates that we increase our focus and direct our expenditures solely on those programs, and so we’ve made the tough, but prudent, decision to substantially reduce our investment in discovery research. This reprioritization and additional financing further extend our cash runway into the second half of 2028. It’s with a heavy heart that we say goodbye to our colleagues impacted by the resulting workforce reduction. We are grateful for their many contributions to ORIC, we’re deeply sorry for the upheaval they are experiencing, and we sincerely hope to honor them by advancing our clinical pipeline to benefit patients as rapidly as possible."

Second Quarter 2025 and Other Recent Highlights

ORIC-944: a potent and selective allosteric inhibitor of PRC2

Reported preliminary efficacy and safety data in May 2025, from the ongoing Phase 1b trial of ORIC-944 in combination with AR inhibitors, supporting the potential of ORIC-944 as a best-in-class PRC2 inhibitor that may benefit a broad range of patients with prostate cancer. The data reported as of the May 2025 presentation cutoff dates included:
Broad and deep PSA responses achieved, with 59% PSA50 response rate (confirmed rate of 47%) and 24% PSA90 response rate (all confirmed) in patients with metastatic castration-resistant prostate cancer (mCRPC).
PSA responses were observed across all ORIC-944 dose levels and at comparable rates in combination with apalutamide and with darolutamide; majority of patients were still ongoing with multiple patients approaching one year or more.
Both combination regimens demonstrated a safety profile compatible with long term dosing, with the vast majority of adverse events Grade 1 or 2 and no Grade 4 events.
Presented preclinical ORIC-944 data at the 2025 AACR (Free AACR Whitepaper) Annual Meeting demonstrating synergistic activity and improved progression-free survival when combined with androgen receptor pathway inhibitors in both castration-resistant and castration-sensitive prostate cancer models, validating the clinical exploration of ORIC-944 across the continuum of prostate cancer.
Enozertinib (formerly ORIC-114): a brain penetrant inhibitor that selectively targets EGFR exon 20, HER2 exon 20 and EGFR atypical mutations

Continue to enroll Phase 1b trial of enozertinib as a single-agent in patients with advanced non-small cell lung cancer (NSCLC) with EGFR exon 20, HER2 exon 20, or EGFR atypical mutations, including patients with CNS metastases that are either treated or untreated but asymptomatic, across our 2L+ dose optimization cohorts and 1L expansion cohorts.
Continue to enroll Phase 1b trial of enozertinib in combination with subcutaneous (SC) amivantamab in 1L NSCLC patients with EGFR exon 20 mutations.
The World Health Organization International Nonproprietary Names (INN) expert committee has approved "enozertinib" as the nonproprietary (generic) name for ORIC-114.
Corporate Highlights:

Completed a $125 million private placement financing with participation from new and existing healthcare specialist funds and $119 million in issuances from the ATM (at-the-market) facility. Given current cash and investment position, the Company concluded ATM usage and doesn’t expect to utilize the ATM facility for the foreseeable future.
Announced strategic pipeline prioritization to focus operational and financial resources on the continued advancement of the two lead clinical programs, ORIC-944 and enozertinib. This initiative will result in the elimination of the discovery research group with a corresponding 20% workforce reduction. The Company expects to incur a one-time charge of approximately $1.9 million in the third quarter, primarily related to termination benefits, including severance and healthcare-related benefits. The Company will explore potential partnering of its preclinical programs.
As a result of the strategic pipeline prioritization, cash runway is expected to fund the revised operating plan into 2H 2028 (previously 2H 2027), which is beyond anticipated primary endpoint readouts from the first Phase 3 trials for ORIC-944 and enozertinib.
Anticipated Program Milestones:

ORIC anticipates the following upcoming data milestones:

ORIC-944 (mCRPC):
2H 2025: Updated Phase 1b combination data with AR inhibitor(s)
1Q 2026: Combination dose optimization data with AR inhibitor(s)
Enozertinib (ORIC-114) (NSCLC):
2H 2025: 1L EGFR exon 20, 2L EGFR exon 20, 2L+ HER2 exon 20 and 2L+ EGFR atypical data
Mid-2026: 1L EGFR atypical data and 1L EGFR exon 20 combination with SC amivantamab data
Second Quarter 2025 Financial Results

Cash, Cash Equivalents and Investments: Cash, cash equivalents and investments totaled $327.7 million as of June 30, 2025, which includes proceeds from $125.0 million private placement financing in May 2025 and $8.9 million in proceeds from an at-the-market offering of common stock during the quarter. Subsequent to the quarter ended June 30, 2025, the Company raised an additional $108.7 million in net proceeds under the ATM program resulting in proforma cash and investments of $436.4 million as of June 30, 2025. The Company now expects its cash and investments to fund the revised operating plan into 2H 2028.
R&D Expenses: Research and development (R&D) expenses were $30.5 million for the three months ended June 30, 2025, compared to $28.9 million for the three months ended June 30, 2024, an increase of $1.6 million. For the six months ended June 30, 2025, R&D expenses were $55.2 million, compared to $50.9 million for the six months ended June 30, 2024, an increase of $4.3 million. The increases were due to higher personnel costs, including additional non-cash stock-based compensation, and costs related to the advancement of enozertinib, offset primarily by lower costs from discontinued programs.
G&A Expenses: General and administrative (G&A) expenses were $8.5 million for the three months ended June 30, 2025, compared to $7.1 million for the three months ended June 30, 2024, an increase of $1.4 million. For the six months ended June 30, 2025, G&A expenses were $16.6 million, compared to $14.1 million for the six months ended June 30, 2024, an increase of $2.5 million. The increases were primarily due to higher personnel costs and professional services, including additional non-cash stock-based compensation.

On August 12, 2025 Fate Therapeutics, Inc. (NASDAQ: FATE), a clinical-stage biopharmaceutical company dedicated to bringing a first-in-class pipeline of induced pluripotent stem cell (iPSC)-derived off-the-shelf cellular immunotherapies to patients, reported business highlights and financial results for the second quarter ended June 30, 2025 (Press release, Fate Therapeutics, AUG 12, 2025, View Source [SID1234655134]).

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"We begin the second half of the year with meaningful progress across our clinical programs as we continue our mission to make cell therapies accessible to all. Our priority remains focused on driving patient enrollment to demonstrate both the therapeutic differentiation and unique on-demand availability of FT819 in autoimmune diseases. We remain encouraged by the promising FT819 data in SLE and LN we reported this past quarter, showing significant disease improvement with less-intensive or no conditioning, and have made strides in expanding our trial sites and accelerating enrollment. Building on this momentum, we are also working closely with the FDA under our RMAT designation with the goal of commencing our registrational study for FT819 in SLE and LN in 2026," said Bob Valamehr, Ph.D., MBA, President and Chief Executive Officer of Fate Therapeutics. "Additionally, we continue to strengthen our broader pipeline programs with an extended partnership with Ono Pharmaceuticals, and advancements in bringing our next-generation, off-the-shelf CAR T cells with Sword and Shield technology toward the clinic. Operationally, we have taken proactive steps to optimize our resource allocation and extend our cash runway, positioning us well to continue executing across our pipeline, working to bring transformative off-the-shelf cellular immunotherapies to patients with unmet needs."

FT819 iPSC-derived off-the-shelf CAR T-cell program in autoimmune disease

In discussion with the FDA on potential registrational study design in moderate-to-severe SLE and refractory LN. In August, the Company met with the U.S. Food and Drug Administration (FDA) under its Regenerative Medicine Advanced Therapy (RMAT) designation for FT819 to seek preliminary feedback on a proposed registrational study design to support regulatory approval in moderate-to-severe SLE and refractory LN. In April 2025, the Company was granted RMAT designation by the FDA for FT819 to treat moderate-to-severe SLE, including LN. Established under the 21st Century Cures Act, the RMAT designation program was created to expedite the development and review of regenerative medicine therapies for serious or life-threatening diseases or conditions.
Interim Phase 1 SLE data using fludarabine-free conditioning regimen presented at EULAR congress and patient enrollment ongoing. The Phase 1 clinical trial of FT819 for the treatment of patients with moderate-to-severe SLE, including patients with LN and with extrarenal lupus (NCT06308978), continues enrolling patients at two dose levels – a single dose of 360 million cells and a single dose of 900 million cells. The Company intends to identify a recommended dose for a registration enabling study and continues to expand clinical site activation in the U.S. and entry into European Union and United Kingdom to broaden geographic reach. At the European Alliance of Associations for Rheumatology (EULAR) 2025 Congress in June, interim Phase 1 data from patients with moderate-to-severe SLE with or without LN using a fludarabine-free conditioning regimen was presented. Three patients with refractory active LN (median prior therapies = 8 [7-8]) were treated with a single dose of FT819 at 360 million cells following a fludarabine (flu)-free conditioning regimen. As of the data cut-off date of May 15, 2025, all three patients achieved an objective renal response. The first LN patient achieved DORIS as well as complete renal response at 6 months, which was also noted at 12-month follow up. Additionally, one patient with refractory extrarenal lupus (prior therapies = 6, including cyclophosphamide; SLEDAI-2K = 18) was treated with a single dose of FT819 at 900 million cells and a single dose of cyclophosphamide. The patient was evaluable for 1-month follow-up, demonstrating improvement across multiple disease-specific scores including an 8-point reduction in SLEDAI-2K from baseline and a 1-point reduction in physician’s global assessment (PGA).
First SLE patient treated as add-on to standard-of-care maintenance therapy. The Company’s Phase 1 SLE study is also designed to assess the safety, pharmacokinetics, and anti-B cell activity of FT819 as an add-on to maintenance therapy without conditioning chemotherapy. At the EULAR Congress in June, the Company reported that the first patient treated while on maintenance therapy, a stable dose of mycophenolate mofetil and steroids for the treatment of refractory extrarenal lupus, received a single dose of FT819 at 360 million cells as an add-on to maintenance therapy (prior therapies = 5). As of the data cut-off date of May 15, 2025, the patient achieved low lupus disease activity state (LLDAS) at 3- and 6-months following administration of FT819 in the absence of conditioning. The patient also experienced a reduction in SLEDAI-2K to 2 from 8 at baseline and in PGA to 0.5 from 2 at baseline, with tapering of steroid dose to less than 5 mg / day. Patient enrollment is ongoing with the aim of investigating patient outcome with single- or multiple-doses of FT819 within a treatment cycle.
Phase 1 SLE study amended to include additional B cell-mediated autoimmune diseases. The Company has expanded its current Phase 1 clinical trial of FT819 to include clinical investigation of multiple B cell-mediated autoimmune diseases, with plans to initiate independent dose-expansion cohorts in the second half of 2025 for the treatment of anti-neutrophil cytoplasmic antibody-associated vasculitis (AAV), idiopathic inflammatory myositis (IIM), and systemic sclerosis (SSc).
FT825 / ONO-8250 iPSC-derived off-the-shelf CAR T-cell Program in Solid Tumors

Phase 1 study ongoing for advanced solid tumors. Under its collaboration with Ono Pharmaceutical Co., Ltd. (Ono), the Company is conducting a multi-center, Phase 1 study to assess the safety, pharmacokinetics, and activity of FT825 / ONO-8250, a multiplex-engineered CAR T-cell product candidate targeting human epidermal growth factor receptor 2 (HER2), in patients with advanced solid tumors (NCT06241456). The study now includes fresh-biopsy testing for HER2 expression to ensure patient stratification and eligibility based on HER2 status. Dose escalation is currently ongoing at the third dose level of 900 million cells, with each patient administered conditioning chemotherapy and a single dose of FT825 / ONO-8250 either as monotherapy or in combination with epidermal growth factor receptor (EGFR)-targeted monoclonal antibody therapy. FT825 / ONO-8250 has demonstrated a favorable safety profile with no dose-limiting toxicities (DLTs) to date.
Next-generation iPSC-derived off-the-shelf CAR T-cell Programs with Novel Sword & Shield Technology Designed to Reduce or Eliminate the Need for Conditioning Chemotherapy

IND allowance by FDA for FT836 MICA/B-targeted CAR T-cell program. In July, the FDA allowed the Company’s investigational new drug (IND) application to initiate Phase 1 clinical testing of FT836, a multiplex-engineered CAR T-cell product candidate uniquely targeting major histocompatibility complex (MHC) proteins A (MICA) and B (MICB) which are expressed on many types of cancer cells with limited detection on healthy tissue. The Phase 1 study is designed to assess the safety and activity of FT836 without administration of conditioning chemotherapy for the treatment of advanced solid tumors. The development of FT836 is supported by a $4 million award from the California Institute of Regenerative Medicine (CIRM).
Creation of master iPSC bank for FT839 dual-CAR T-cell program. FT839 is a CD19/CD38 dual CAR T-cell product candidate designed to target an array of aberrant immune cells. At the American Society of Gene & Cell Therapy (ASGCT) (Free ASGCT Whitepaper) Annual Meeting in May, the Company presented preclinical data demonstrating robust eradication of aberrant CD19+ B cells, CD38+ plasma cells, and CD38+ activated T cells by FT839 using unmatched peripheral blood mononuclear cells sourced from a patient with autoimmune disease. The Company has generated a master iPSC bank for conduct of further preclinical and IND-enabling studies, and is currently evaluating opportunities for clinical investigation of FT839 in hematological malignancies and autoimmunity, beginning in 2026.
Other Corporate Updates

Extension of Ono collaboration for second solid tumor CAR T-cell product candidate. Under its collaboration with Ono, the Company is conducting preclinical development of a second iPSC-derived CAR T-cell candidate targeting an undisclosed solid tumor antigen. Based on a review of the preclinical data package for the collaboration candidate in June, the Company and Ono agreed to extend the collaboration’s research term and continue further preclinical development of the candidate. The Company expects to continue to receive co-funding from Ono in connection with its preclinical development activities under the joint research plan through at least June 2026.
Operating runway extension. The Company has implemented a tactical operations plan that is expected to extend funding of its operations through the end of 2027, which is intended to enable the achievement of key clinical and collaboration milestones while maintaining sufficient funds to support ongoing operations beyond those milestones. The cash runway extension includes the pipeline prioritization of its iPSC-derived CAR T-cell programs, a 12% reduction in its current employee headcount, and cost saving measures across the organization.
Second Quarter 2025 Financial Results

Cash & Investment Position: Cash, cash equivalents, and investments as of June 30, 2025 were $248.9 million.
Total Revenue: Revenue was $1.9 million for the second quarter of 2025, which was derived from the conduct of preclinical development activities for a second collaboration candidate targeting an undisclosed solid tumor antigen under the Company’s collaboration with Ono Pharmaceutical.
Total Operating Expenses: Total operating expenses were $38.9 million for the second quarter of 2025, including research and development expenses of $27.4 million and general and administrative expenses of $11.4 million. Such amount included $7.2 million of non-cash stock-based compensation expense.
Shares Outstanding: As of June 30, 2025, common shares outstanding were 114.7 million, pre-funded warrants outstanding were 3.9 million, and preferred shares outstanding were 2.8 million. Each preferred share is convertible into five common shares.

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."