On August 13, 2025 Xenetic Biosciences, Inc. (NASDAQ:XBIO) ("Xenetic" or the "Company"), a biopharmaceutical company focused on advancing innovative immuno-oncology technologies addressing difficult to treat cancers, reported its financial results for the second quarter 2025 (Press release, Xenetic Biosciences, AUG 13, 2025, View Source [SID1234655164]).

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Recent Highlights

Expanded its collaboration with The Scripps Research Institute ("TSRI") to advance the development of the Company’s development program evaluating the combination of systemic DNase I and CAR T-cell therapies;

Announced advancements from its collaboration partner, PeriNess Ltd. ("PeriNess") including:

Entered into a Clinical Study Agreement to support an exploratory clinical study of DNase I in combination with anti-CD19 CAR T cells in patients with large B cell lymphoma;

Commenced patient dosing in an exploratory clinical study of systemic DNase I in combination with FOLFIRINOX for the first line treatment of unresectable, locally advanced or metastatic pancreatic cancer at Bnei Zion Medical Center; and

Continued pursuit of other strategic collaborations to advance the Company’s technology.

"We continue to set a strong foundation that we believe positions us for success as we advance our systemic DNase I in combination with immunotherapy, chemotherapy, and radiotherapy across various oncology indications where there remains significant unmet need. We continue to work with our partners and believe the data and information will be invaluable as we look to realize the full potential of our DNase platform technology. Looking ahead, we remain focused on building momentum across all fronts and driving development toward an IND and Phase 1 clinical trial," commented James Parslow, Interim Chief Executive Officer and Chief Financial Officer of Xenetic.

Xenetic continues to advance its DNase-based technology towards Phase 1 clinical development for the treatment of pancreatic carcinoma and other locally advanced or metastatic solid tumors. Preclinical proof-of-concept studies combining DNase I with chemotherapy, immunotherapies, and CAR-T therapy in hematological and solid tumor and metastatic cancer models have been completed. Building on proof-of-concept success, the program has now advanced to mechanism-of-action and translational studies in preparation for a Phase 1 clinical trial.

Additionally, as previously announced in December 2024, Xenetic entered into a Clinical Trial Services Agreement with PeriNess, under which PeriNess will lead in the regulatory approval, operational execution and management of potential exploratory, investigator initiated studies of recombinant DNase as an adjunctive treatment in patients with pancreatic carcinoma and other locally advanced or metastatic solid tumors receiving chemotherapy and immunotherapy in Israeli medical centers.

Summary of Financial Results for Second Quarter 2025

Net loss for the quarter ended June 30, 2025 was approximately $0.7 million. Research & development expenses for the three months ended June 30, 2025 decreased by approximately $277,000, or 29.7%, to approximately $0.7 million from $0.9 million in the comparable quarter in 2024. General and administrative expenses for the three months ended June 30, 2025 decreased by approximately $472,000, or 41.8%, to approximately $0.7 million from approximately $1.1 million in the comparable quarter in 2024. These decreases were primarily due to certain severance and benefits expensed in connection with separation agreements entered into during the second quarter of 2024 with the Company’s former Chief Executive Officer and Chief Scientific Officer.

The Company ended the quarter with approximately $4.8 million in cash.

On August 13, 2025 Instil Bio, Inc. ("Instil") (Nasdaq: TIL), a clinical-stage biopharmaceutical company focused on developing a pipeline of novel therapies, reported its second quarter 2025 financial results and provided a corporate update (Press release, Instil Bio, AUG 13, 2025, View Source [SID1234655144]).

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Recent Highlights:

In June, announced the appointment of Jamie Freedman, M.D., Ph.D., as Chief Medical Officer
In July, announced the Investigational New Drug (IND) application for ‘2510 was cleared by the U.S. FDA
In July, ImmuneOnco, Instil’s collaborator, announced preliminary safety and efficacy data from the Phase 2 open-label, multicenter study of ‘2510 in combination with chemotherapy for front-line patients with advanced non-small cell lung cancer (NSCLC) conducted in China by ImmuneOnco
In August, ImmuneOnco announced that an abstract has been accepted for poster presentation at IASLC’s 2025 World Conference on Lung Cancer (September 6th-9th, 2025), which will provide updated results from additional patients with relapsed/refractory squamous-NSCLC treated with ‘2510 as monotherapy
Second Quarter 2025 Financial and Operating Results:

As of June 30, 2025, Instil had cash, cash equivalents, restricted cash, marketable securities and long-term investments of $103.6 million, which consisted of $7.7 million in cash and cash equivalents, approximately $0.2 million in restricted cash, $84.1 million in marketable securities, and $11.7 million in long-term investments, compared to $115.1 million in cash, cash equivalents, restricted cash and marketable securities as of December 31, 2024, consisting of $8.8 million in cash and cash equivalents, $1.8 million in restricted cash, and $104.5 million in marketable securities. Instil expects that its cash, cash equivalents, marketable securities and long-term investments as of June 30, 2025 will enable it to fund its operating plan beyond 2026.

In-process research and development expenses were $10.0 million for both the three and six months ended June 30, 2025, compared to nil for both the three and six months ended June 30, 2024.

Research and development expenses were $6.7 million and $12.1 million for the three and six months ended June 30, 2025, respectively, compared to $2.9 million and $10.2 million for the three and six months ended June 30, 2024, respectively.

General and administrative expenses were $6.2 million and $15.3 million for the three and six months ended June 30, 2025, respectively, compared to $10.7 million and $23.1 million for the three and six months ended June 30, 2024, respectively.

Restructuring and impairment charges were $0.5 million and $16.6 million for the three and six months ended June 30, 2025, respectively, compared to $0.5 million and $4.8 million for three and six months ended June 30, 2024, respectively.

Net loss per share, basic and diluted were $3.24 and $7.55 for the three and six months ended June 30, 2025, respectively, compared to $2.29 and $6.03 for the three and six months ended June 30, 2024, respectively. Non-GAAP net loss per share, basic and diluted, were $2.88 and $4.21 for the three and six months ended June 30, 2025, respectively, compared to $1.57 and $3.95 for the three and six months ended June 30, 2024, respectively.

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 Rakovina Therapeutics Inc. ("Rakovina" or the "Company") (TSX-V: RKV) (FSE: 7JO0), a biopharmaceutical company advancing cancer therapies through artificial intelligence (AI)-powered drug discovery and NanoPalm Ltd., a Saudi-based biotechnology company pioneering advanced patterned lipid nanoparticle (pLNP) delivery systems, reported the signing of a non-binding Letter of Intent (LOI) (Press release, Rakovina Therapeutics, AUG 12, 2025, View Source;utm_medium=rss&utm_campaign=rakovina-therapeutics-and-nanopalm-ltd-sign-letter-of-intent-to-form-joint-venture-leveraging-al-discovered-oncology-therapies-and-novel-lipid-nanoparticle-delivery-technologies [SID1234655206]). The LOI outlines the intention to form a joint venture to co-develop novel small-molecule oncology therapeutics, beginning with loading Rakovina’s dual-function PARP-HDAC inhibitor, kt3283, into Nano Palm’s pLNP technology.

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The collaboration brings together two novel platforms: Rakovina’s proprietary Al-enabled drug discovery engine, powered by an exclusive license to the proprietary Deep Docking platform, is capable of rapidly screening billions of molecules against validated cancer targets and predicting drug-like characteristics in silico, and NanoPalm’s next-generation self-targeting pLNP delivery system, Al-designed to enhance the precision and efficacy of therapeutic delivery. Promising candidates discovered through Rakovina’s platform and formulated with Nanopalm’s pLNP technology will be validated through Rakovina’s in-house pharmacology, toxicology, and in vivo models, creating a seamless path from in silico modeling to formulation to preclinical proof of concept.

kt-3283, the initial development candidate under the proposed joint venture, is a potent small-molecule inhibitor that simultaneously targets PARP and HDAC – two critical cancer survival pathways. Preclinical studies have demonstrated that kt-3283 induces DNA damage, disrupts cell-cycle progression, and produces enhanced cytotoxicity compared to currently approved PARP and HDAC inhibitors. The compound has shown particularly strong activity in Ewing sarcoma, breast, and ovarian cancer models, with data presented at major oncology conferences and published in a peer-reviewed journal.

NanoPalm’s pLNP technology, originally developed for gene therapy, uses Al-assisted formulation design and tunable shape & surface characteristics to improve tissue specificity, intracellular delivery, and systemic tolerability. This collaboration represents an initial oncology application of NanoPalm’s proprietary platform to small-molecule therapeutics, offering the potential to significantly enhance kt-3283’s therapeutic index and tumor-specific delivery. NanoPalm’s pLNP platform has been validated in multiple preclinical gene therapy programs, demonstrating superior delivery precision and biodistribution compared to conventional LNPs.

NanoPalm’s technology is differentiated by its Al-assisted design and modular architecture, enabling tunable surface properties and selective cellular uptake. Originally developed for gene therapy applications, this collaboration represents NanoPalm’s strategic entry into the oncology field.

"This collaboration brings together complementary expertise in drug discovery and delivery technologies," said Jeffrey Bacha, Executive Chairman of Rakovina Therapeutics. "kt-3283 represents the first of what we believe could be multiple novel therapeutics that emerge from this alliance, offering a robust pipeline for development and future commercialization."

"We are excited to partner with Rakovina Therapeutics to bring our precision pLNP delivery technology into oncology for the first time," said Dr. Ali Alhasan, Founder and CEO of NanoPalm. "Our platform is uniquely suited to improve the delivery profile of small-molecule therapies, and the synergy with Rakovina’s innovative discovery capabilities creates an opportunity for the potential joint venture to pursue worldwide development and commercialization opportunities within Saudi Arabia as its operational hub to develop transformative treatments for patients with cancer. This aligns with the Kingdom’s National Biotechnology Strategy, leveraging the local fertile ground for innovating and accelerating local biotech development."

Once finalized, the joint venture will initially focus on advancing kt-3283 through late preclinical development and early clinical studies while evaluating additional Al-derived drug candidates for inclusion in the development pipeline. The partners also plan to explore global licensing and strategic commercialization opportunities as the pipeline matures.

Defined Responsibilities and Global Scope

Under the proposed joint venture:

Rakovina will contribute kt-3283 drug substance and additional select Al-discovered small-molecule drug candidates, along with supporting in vitro and in vivo validation, pharmacology, toxicology, CMC data, and regulatory expertise.
NanoPalm will contribute its proprietary pLNP platform, biomanufacturing capabilities, delivery science expertise, and preclinical and clinical support infrastructure in Saudi Arabia.
Joint development activities will be coordinated under a mutually agreed governance structure, with initial preclinical validation conducted in Rakovina’s research facilities at the University of British Columbia and manufacturing and biodistribution studies conducted by NanoPalm in Saudi Arabia.
The partners will co-fund the joint venture, pursue third-party investment and non-dilutive grant opportunities, and share equally in ownership, risk, and upside.
Global Reach and Strategic Alignment

The joint venture will be domiciled in Saudi Arabia, with a worldwide development and commercialization mandate. This JV will be the first pLNP-oncology-focused biotech co-founded in Saudi Arabia integrating locally developed nanomedicine with global drug discovery platforms. Development activities will be aligned with international regulatory standards, including those of the FDA, SFDA, and EMA. The parties have committed to a non-exclusive collaboration model, with exclusivity defined for programs combining Rakovina’s compounds with NanoPalm’s delivery technology in oncology and other mutually agreed indications.

Intellectual property arising from the collaboration will be jointly owned, with background IP and technology improvements retained by their respective inventors. Each party will non-exclusively license its IP to the JV for the purpose of fulfilling the venture’s objectives.

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.