On November 20, 2025 Mission Bio, a leader in single-cell multi-omics solutions for precision medicine, reported its Tapestri Single-Cell Targeted DNA + RNA Assay, the first commercial platform to measure genotypic and transcriptional readouts within the same cell. The assay empowers oncology and translational researchers to directly link mutations to their functional consequences, uncovering the mechanisms that drive resistance, relapse, and therapeutic response– advancing precision medicine to enable more effective therapeutic innovation.

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Advancements have been made in mapping clonal architecture in blood cancers via single-cell genotyping. However, linking these genetic mutations to gene expression, the driver of phenotype and treatment response, remains a major challenge. The Tapestri Targeted DNA + RNA Assay unifies both genotyping and gene expression in the same cell, eliminating multi-platform data integration and heavy computational alignment, enabling investigators to observe how mutations influence transcriptional states in acute myeloid leukemia, myelodysplastic syndromes, and engineered cell therapies.

Peer-reviewed work published in Nature Methods using the Tapestri platform showed that cells with higher mutational burden exhibit enhanced tumorigenic gene expression and B-cell-receptor signaling, evidence of the method’s sensitivity and relevance to hematology. Its debut at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting 2025 coincides with a broader shift toward functional, single-cell multi-omic profiling in translational hematology.

"The DNA+RNA assay provides powerful resolution into the mutational landscape and cell states within leukemia," says Bobby Bowman, PhD, Assistant Professor, University of Pennsylvania, Department of Cancer Biology. "With this assay, we were able to chart clonal evolution in response to therapy, and resolve not only which clones survived but the gene expression programs that emerged following therapy."

The assay unites targeted genotyping and transcript quantification in a single workflow, analyzing thousands of cells per run and quantifying expression of up to 200 transcripts to link genetic changes with their functional impact. The design preserves existing Tapestri chemistry and instrumentation, allowing current users to add RNA capability without re-validation of laboratory infrastructure or data pipelines.

"For translational and cell therapy researchers, combining DNA and RNA signals from the same cells reveals how variants act in real time," said Adam Sciambi, PhD, Mission Bio CTO and co-founder. "It turns inference into direct observation, an essential step toward mechanistic insights for next-generation therapies."

The assay is currently offered for research use only and will be featured in demonstrations at ASH (Free ASH Whitepaper) on Dec. 6-9, 2025, at Booth #2129, where Mission Bio will highlight use cases spanning therapy resistance, relapse modeling, and preclinical quality assessment.

This launch continues Mission Bio’s leadership in single-cell multi-omics. Adding RNA expression profiling to the established Tapestri platform used worldwide across cancer research, pharmaceutical development, and cell and gene therapy programs demonstrates Mission Bio’s focus in helping investigators truly understand the biological complexity of diseases at the single-cell level. By enabling the simultaneous analysis of genotype and gene expression within the same cells, Mission Bio has established a new analytical standard for translational hematology and engineered cell development.

For more information, you can visit View Source and View Source

(Press release, Mission Bio, NOV 20, 2025, View Source [SID1234660856])

On November 19, 2025 Soligenix, Inc. (Nasdaq: SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, reported that it has completed the planned enrollment of 50 patients necessary for the interim analysis in its 80 patient confirmatory Phase 3 double-blind, placebo-controlled study evaluating HyBryte (synthetic hypericin) in the treatment of cutaneous T-cell lymphoma (CTCL). The confirmatory Phase 3 study (Fluorescent Light Activated Synthetic Hypericin 2, FLASH2), builds on the previous statistically significant Phase 3 (FLASH) study, as well as a recent successful comparative study (HPN-CTCL-04) and an ongoing investigator-initiated study .

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"We are pleased to have reached this important milestone in patient enrollment consistent with our timelines for the FLASH2 study," stated Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix. "With 50 patients enrolled, the planned interim analysis will occur in the second quarter of 2026. FLASH2 was designed as a highly powered confirmatory study with an anticipated overall blinded study response rate of 25% (based on the conservative assumptions of a 40% response rate in the HyBryte arm and a 10% response rate in the placebo arm through 18 weeks). When considering all patients that have completed the treatment phase of the study to date, our overall blinded study response rate is 48%. We look forward to completing this study on schedule with topline results in the second half of 2026."

"The findings so far are consistent with the ongoing open-label, investigator-initiated study being conducted at my institution where HyBryte has demonstrated a response rate of 75% after 18 weeks of treatment," stated Ellen Kim, MD, Director, Penn Cutaneous Lymphoma Program, Vice Chair of Clinical Operations, Dermatology Department, Professor of Dermatology at the Hospital of the University of Pennsylvania, and Lead Investigator of the FLASH2 study. "The benign safety profile we observed in the first FLASH study, as well as in the ongoing investigator-initiated study, continues to be observed in FLASH2, as evidenced by the recently achieved safety review milestone."

FLASH2 is a randomized, double-blind, placebo-controlled, multicenter study that is enrolling approximately 80 subjects with early-stage CTCL. The study Data Monitoring Committee (DMC) is empowered to conduct one formal Interim Analysis when approximately 60% (n = 48) of the total patients have completed the primary endpoint evaluation (i.e., Week 18 or before). The study replicates the double-blind, placebo-controlled design used in the first successful Phase 3 FLASH study that consisted of three 6-week treatment cycles (18 weeks total), with the primary efficacy assessment occurring at the end of the initial 6-week double-blind, placebo-controlled treatment cycle (Cycle 1). However, this second study extends the double-blind, placebo-controlled assessment to 18 weeks of continuous treatment (no "between-Cycle" treatment breaks) with the primary endpoint assessment occurring at the end of the 18-week timepoint. In the first Phase 3 study, a treatment response of 49% (p<0.0001 vs patients receiving placebo in Cycle 1) was observed in patients completing 18 weeks (3 cycles) of therapy. In this second study, all important clinical study design components remain the same as in the first FLASH study, including the primary endpoint and key inclusion-exclusion criteria. The extended treatment for a continuous 18 weeks in a single cycle is expected to statistically demonstrate the effect of HyBryte over a more prolonged, "real world" treatment course.

About HyBryte

HyBryte (research name SGX301) is a novel, first-in-class, photodynamic therapy utilizing safe, visible light for activation. The active ingredient in HyBryte is synthetic hypericin, a potent photosensitizer that is topically applied to skin lesions that is taken up by the malignant T-cells, and then activated by safe, visible light approximately 24 hours later. The use of visible light in the red-yellow spectrum has the advantage of penetrating more deeply into the skin (much more so than ultraviolet light) and therefore potentially treating deeper skin disease and thicker plaques and lesions. This treatment approach avoids the risk of secondary malignancies (including melanoma) inherent with the frequently employed DNA-damaging drugs and other phototherapy that are dependent on ultraviolet exposure. Combined with photoactivation, hypericin has demonstrated significant anti-proliferative effects on activated normal human lymphoid cells and inhibited growth of malignant T-cells isolated from CTCL patients. In a published Phase 2 clinical study in CTCL, patients experienced a statistically significant (p=0.04) improvement with topical hypericin treatment whereas the placebo was ineffective. HyBryte has received orphan drug and fast track designations from the FDA, as well as orphan designation from the European Medicines Agency (EMA).

The published Phase 3 FLASH trial enrolled a total of 169 patients (166 evaluable) with Stage IA, IB or IIA CTCL. The trial consisted of three treatment cycles. Treatments were administered twice weekly for the first 6 weeks and treatment response was determined at the end of the 8th week of each cycle. In the first double-blind treatment cycle (Cycle 1), 116 patients received HyBryte treatment (0.25% synthetic hypericin) and 50 received placebo treatment of their index lesions. A total of 16% of the patients receiving HyBryte achieved at least a 50% reduction in their lesions (graded using a standard measurement of dermatologic lesions, the modified Composite Assessment of Index Lesion Severity [mCAILS] score) compared to only 4% of patients in the placebo group at 8 weeks (p=0.04) during the first treatment cycle (primary endpoint). HyBryte treatment in this cycle was safe and well tolerated.

In the second open-label treatment cycle (Cycle 2), all patients received HyBryte treatment of their index lesions. Evaluation of 155 patients in this cycle (110 receiving 12 weeks of HyBryte treatment and 45 receiving 6 weeks of placebo treatment followed by 6 weeks of HyBryte treatment), demonstrated that the response rate among the 12-week treatment group was 40% (p<0.0001 vs the placebo treatment rate in Cycle 1). Comparison of the 12-week and 6-week treatment responses also revealed a statistically significant improvement (p<0.0001) between the two timepoints, indicating that continued treatment results in better outcomes. HyBryte continued to be safe and well tolerated. Additional analyses also indicated that HyBryte is equally effective in treating both plaque (response 42%, p<0.0001 relative to placebo treatment in Cycle 1) and patch (response 37%, p=0.0009 relative to placebo treatment in Cycle 1) lesions of CTCL, a particularly relevant finding given the historical difficulty in treating plaque lesions.

The third (optional) treatment cycle (Cycle 3) was focused on safety and all patients could elect to receive HyBryte treatment of all their lesions. Of note, 66% of patients elected to continue with this optional compassionate use / safety cycle of the study. Of the subset of patients that received HyBryte throughout all 3 cycles of treatment, 49% of them demonstrated a positive treatment response (p<0.0001 vs patients receiving placebo in Cycle 1). Moreover, in a subset of patients evaluated in this cycle, it was demonstrated that HyBryte is not systemically available, consistent with the general safety of this topical product observed to date. At the end of Cycle 3, HyBryte continued to be well tolerated despite extended and increased use of the product to treat multiple lesions.

Overall safety of HyBryte is a critical attribute of this treatment and was monitored throughout the three treatment cycles (Cycles 1, 2 and 3) and the 6-month follow-up period. HyBryte’s mechanism of action is not associated with DNA damage, making it a safer alternative than currently available therapies, all of which are associated with significant, and sometimes fatal, side effects. Predominantly these include the risk of melanoma and other malignancies, as well as the risk of significant skin damage and premature skin aging. Currently available treatments are only approved in the context of previous treatment failure with other modalities and there is no approved front-line therapy available. Within this landscape, treatment of CTCL is strongly motivated by the safety risk of each product. HyBryte potentially represents the safest available efficacious treatment for CTCL. With very limited systemic absorption, a compound that is not mutagenic and a light source that is not carcinogenic, there is no evidence to date of any potential safety issues.

Following the first Phase 3 study of HyBryte for the treatment of CTCL, the FDA and the EMA indicated that they would require a second successful Phase 3 trial to support marketing approval. With agreement from the EMA on the key design components, the second, confirmatory study, called FLASH2, has successfully achieved its first safety review milestone with a pre-specified, blinded interim analysis expected to be completed in 2Q2026. This study is a randomized, double-blind, placebo-controlled, multicenter study that will enroll approximately 80 subjects with early-stage CTCL. The FLASH2 study replicates the double-blind, placebo-controlled design used in the first successful Phase 3 FLASH study that consisted of three 6-week treatment cycles (18 weeks total), with the primary efficacy assessment occurring at the end of the initial 6-week double-blind, placebo-controlled treatment cycle (Cycle 1). However, this second study extends the double-blind, placebo-controlled assessment to 18 weeks of continuous treatment (no "between-Cycle" treatment breaks) with the primary endpoint assessment occurring at the end of the 18-week timepoint. In the first Phase 3 study, a treatment response of 49% (p<0.0001 vs patients receiving placebo in Cycle 1) was observed in patients completing 18 weeks (3 cycles) of therapy. In this second study, all important clinical study design components remain the same as in the first FLASH study, including the primary endpoint and key inclusion-exclusion criteria. The extended treatment for a continuous 18 weeks in a single cycle is expected to statistically demonstrate HyBryte’s increased effect over a more prolonged, "real world" treatment course. Given the extensive engagement with the CTCL community, the esteemed Medical Advisory Board and the previous trial experience with this disease, accelerated enrollment in support of this study is anticipated, including the potential to enroll previously identified and treated HyBryte patients from the FLASH study. Discussions with the FDA on an appropriate study design remain ongoing. While collaborative, the agency has expressed a preference for a longer duration comparative study over a placebo-controlled trial. Given the shorter time to potential commercial revenue and the similar trial design to the first FLASH study afforded by the EMA accepted protocol, this study was initiated. At the same time, discussions with the FDA will continue on potential modifications to the development path to adequately address their feedback.

Additional supportive studies have demonstrated the utility of longer treatment times (Study RW-HPN-MF-01), the lack of significant systemic exposure to hypericin after topical application (Study HPN-CTCL-02) and its relative efficacy and tolerability compared to Valchlor (Study HPN-CTCL-04).

In addition, the FDA awarded an Orphan Products Development grant to support the investigator-initiated study evaluation of HyBryte for expanded treatment in patients with early-stage CTCL, including in the home use setting. The grant, totaling $2.6 million over 4 years, was awarded to the University of Pennsylvania that was a leading enroller in the Phase 3 FLASH study.

About Cutaneous T-Cell Lymphoma (CTCL)

CTCL is a class of non-Hodgkin’s lymphoma (NHL), a type of cancer of the white blood cells that are an integral part of the immune system. Unlike most NHLs which generally involve B-cell lymphocytes (involved in producing antibodies), CTCL is caused by an expansion of malignant T-cell lymphocytes (involved in cell-mediated immunity) normally programmed to migrate to the skin. These malignant cells migrate to the skin where they form various lesions, typically beginning as patches and may progress to raised plaques and tumors. Mortality is related to the stage of CTCL, with median survival generally ranging from about 12 years in the early stages to only 2.5 years when the disease has advanced. There is currently no cure for CTCL. Typically, CTCL lesions are treated and regress but usually return either in the same part of the body or in new areas.

CTCL constitutes a rare group of NHLs, occurring in about 4% of the more than 1.7 million individuals living with the disease in the U.S. and Europe (European Union and United Kingdom). It is estimated, based upon review of historic published studies and reports and an interpolation of data on the incidence of CTCL that it affects approximately 31,000 individuals in the U.S. (based on SEER [Surveillance, Epidemiology, and End Results] data, with approximately 3,200 new cases seen annually) and approximately 38,000 individuals in Europe (based on ECIS [European Cancer Information System] prevalence estimates, with approximately 3,800 new cases annually).

(Press release, Soligenix, NOV 19, 2025, View Source [SID1234660093])

On November 19, 2025 Aptose Biosciences Inc. ("Aptose" or the "Company") (TSX: APS; OTC: APTOF) and Hanmi Pharmaceutical Co. Ltd. ("Hanmi") reported that Aptose, Hanmi and HS North America Ltd., a wholly owned subsidiary of Hanmi ("Hanmi Purchaser" and together with Hanmi, the "Hanmi Purchasers"), have entered into a definitive arrangement agreement (the "Arrangement Agreement") pursuant to which Hanmi Purchaser will acquire all of the issued and outstanding common shares of Aptose ("Common Shares") that are not currently owned or controlled by the Hanmi Purchasers or their respective affiliates.

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Hanmi has participated in multiple financings of Aptose and owns 19.93% of all outstanding Common Shares. During the past 18 months, Hanmi has singularly supported Aptose and the continued development of tuspetinib (TUS) through debt facilities to Aptose totaling more than US$30 million. Under the terms of the Arrangement Agreement, upon the completion of the transactions contemplated under the Arrangement Agreement, Aptose shareholders, other than the Hanmi Purchasers and their respective affiliates that hold any Common Shares, will receive C$2.41 in cash per Common Share, which represents a premium of 28% over Aptose’s 30-day VWAP of C$1.88 on the Toronto Stock Exchange (TSX).

"We are very pleased to have reached an agreement on a transaction with Hanmi," stated William G. Rice, Ph.D., Chairman, President, and Chief Executive Officer of Aptose. "This transaction not only offers a premium value for our minority shareholders but also enables Aptose to continue the development of TUS combined with standard treatment venetoclax plus azacitidine (VEN+AZA) for acute myeloid leukemia (AML) in the TUSCANY Phase 1/2 clinical study. The TUS+VEN+AZA triplet therapy has shown promising response rates and safety in a diverse population of patients newly diagnosed with AML. We are extremely grateful for Hanmi’s ongoing support as we work toward our long-term goal of improving patient outcomes in AML."

"We are very pleased to have reached this agreement with Aptose," said Jae-Hyun Park of Hanmi. "With a growing body of positive data, it is important to support the uninterrupted and expanded development of tuspetinib in the TUSCANY clinical study. This step also marks Hanmi’s first beachhead and direct entry into North America, establishing a strategic foothold for future partnerships and clinical expansion in the region."

Transaction Details

Under the terms of Arrangement Agreement, Aptose will continue from a corporation incorporated under the Canada Business Corporations Act to a corporation continued under the Business Corporations Act (Alberta) (the "Continuance") and, following the completion of the Continuance, Hanmi Purchaser will acquire all of the issued and outstanding Common Shares that are not currently owned or controlled by the Hanmi Purchasers or their respective affiliates by way of a plan of arrangement under the Business Corporations Act (Alberta) (the "Arrangement" and, together with the Continuance, the "Transaction").

Upon the completion of the Transaction, subject to applicable tax withholdings:

each Common Share (other than any Common Share owned or controlled by the Hanmi Purchasers or their respective affiliates or for which dissent rights have been validly exercised) will be transferred to Hanmi Purchaser in exchange for an amount in cash equal to C$2.41 per Common Share;
each Aptose option will cease to represent an option or other right to acquire any Common Share and will be deemed surrendered and exchanged for an amount in cash equal to C$2.41 per Common Share, multiplied by the number of Common Shares subject to the Aptose option, less the aggregate exercise price in respect of such Aptose option;
each Aptose restricted share unit will cease to represent a share unit of Aptose and will be deemed surrendered and exchanged for an amount in cash equal to C$2.41 per Common Share, multiplied by the number of Common Shares subject to the Aptose restricted share unit;
each Aptose warrant held by Armistice Capital Master Fund Ltd. (the "Armistice Warrants") will cease to represent a warrant exercisable for Common Shares and will be deemed surrendered and exchanged for an amount in cash equal to an amount calculated using the "Black Scholes" valuation model in accordance with the terms of the applicable Armistice Warrant; and
each Aptose warrant (other than the Armistice Warrants) will cease to represent a warrant exercisable for Common Shares and will be deemed surrendered and exchanged for an amount in cash equal to C$2.41 per Common Share, multiplied by the number of Common Shares subject to the Aptose warrant, less the aggregate exercise price in respect of such Aptose warrant.
The Arrangement Agreement contains customary non-solicitation provisions prohibiting Aptose from soliciting competing acquisition proposals, as well as "right to match" provisions in favour of Hanmi Purchaser. The Arrangement Agreement provides for a C$300,000 expense fee payable to Hanmi Purchaser if the Arrangement Agreement is terminated in certain circumstances, including in the context of a change in recommendation by the board of directors of Aptose (the "Board") or by the special committee consisting of independent members of the Board formed in connection with the Arrangement (the "Special Committee").

The completion of the Transaction is subject to satisfaction of customary closing conditions, including court approval and approval of Aptose shareholders as further set out below. After completion of the Transaction, Aptose expects to no longer be subject to the reporting requirements of applicable Canadian securities legislation and the Common Shares will be delisted from all stock exchanges where Common Shares are currently listed, including the TSX.

Completion of the Transaction will be subject to the approval of (i) at least two-thirds (66 2/3%) of the votes cast by Aptose shareholders present in person or represented by proxy at a special meeting of Aptose shareholders to be held no later than January 16, 2026 to approve the Transaction (the "Special Meeting"), voting as a single class, and (ii) the majority of the holders of Common Shares present in person or represented by proxy at the Special Meeting, excluding the votes of the Hanmi Purchasers and their respective affiliates, and any other shareholders whose votes are required to be excluded for the purposes of "minority approval" under Multilateral Instrument 61-101 – Protection of Minority Security Holders in Special Transactions ("MI 61-101") in the context of a "business combination" (the "Minority Shareholders"). Further details regarding the applicable voting requirements will be contained in a management information circular to be filed and mailed to Aptose shareholders in connection with the Special Meeting to approve the Transaction.

Concurrent with the execution of the Arrangement Agreement, Hanmi Purchaser entered into voting support agreements with each of the directors and officers of Aptose pursuant to which, subject to the terms of the voting support agreements, each Aptose director or officer has agreed to, among other things, vote or cause to be voted all of the Common Shares owned, controlled or directed, directly or indirectly, by them in favour of the Transaction at the Special Meeting.

Further details of the Transaction are set out in the Arrangement Agreement, which will be made available on Aptose’s SEDAR+ profile at www.sedarplus.ca.

Opinion and Formal Valuation

Locust Walk Securities, LLC ("Locust Walk") was retained by the Special Committee to provide financial advice and prepare a formal valuation of the Common Shares, as required under MI 61-101. Locust Walk delivered a valuation that, as of November 18, 2025, and based on Locust Walk’s analysis and subject to the assumptions, limitations and qualifications to be set forth in the formal valuation that will be included in the management information circular that will be sent to Aptose shareholders in connection with the Special Meeting (the "Formal Valuation"), using multiple analyses, including DCF modeling, the fair market value of the Common Shares is in the range of C$1.00 to C$5.23 per Common Share. Locust Walk has also delivered an oral opinion (the "Fairness Opinion") to the Special Committee that, as of November 18, 2025, and subject to the assumptions, limitations and qualifications to be set forth in Locust Walk’s written fairness opinion that will be included in the management information circular, the consideration to be received by the holders of Common Shares (other than the Hanmi Purchasers and their respective affiliates) pursuant to the Arrangement Agreement is fair, from a financial point of view, to such holders of Common Shares. The management information circular will also include factors considered by the Special Committee and the Board and other relevant information.

Unanimous Approval of Aptose Special Committee and Board of Directors

The Special Committee, after consultation with and receiving advice from its financial adviser and outside legal counsel, has unanimously recommended that the Board approve the Arrangement and that Aptose shareholders vote in favour of the Arrangement.

The Board, acting on the unanimous recommendation in favour of the Arrangement by the Special Committee and after receiving advice from its financial adviser and outside legal counsel in evaluating the Arrangement, has unanimously determined that the Arrangement is fair to Aptose shareholders (other than the Hanmi Purchasers and their respective affiliates) and that the Arrangement is in the best interests of Aptose, and resolved to unanimously recommend that Aptose shareholders vote in favour of the Arrangement.

Advisors

Locust Walk is acting as financial advisor and independent valuator to the Special Committee and the Company. McCarthy Tétrault LLP is acting as independent legal advisor to the Special Committee and the Company. Stikeman Elliott LLP is acting as independent legal advisor to Hanmi Purchaser.

About Tuspetinib

Aptose’s lead compound tuspetinib is a convenient once daily oral agent that potently targets SYK, mutated and wild type forms of FLT3, mutated KIT, JAK1/2, and RSK2 kinases, while avoiding many typical toxicity concerns observed with other agents. The ongoing TUSCANY triplet Phase 1/2 study is designed to test various doses and schedules of TUS in combination with standard dosing of azacitidine and venetoclax in newly diagnosed patients with AML who are ineligible to receive induction chemotherapy. Aptose has reported data from the first three dose cohorts that have demonstrated safety, CRs and minimal residual disease (MRD) negativity across patients with diverse mutations. The early data showed that 9 out of 10 patients responded to the TUS triplet therapy, with 100% complete remission (CR/CRh) achieved in the 80mg and 120mg cohorts. Notably, patients with difficult-to-treat mutations in TP53, RAS and FLT3 genes also achieved a 100% CR/CRh rate.

(Press release, Aptose Biosciences, NOV 19, 2025, View Source [SID1234660075])

On November 19, 2025 Tempest Therapeutics, Inc. (Nasdaq: TPST) ("Tempest" or "the Company"), a clinical-stage biotechnology company with a pipeline of targeted and immune-mediated therapeutics to fight cancer, reported that it has entered into definitive agreements to acquire certain dual-targeting chimeric antigen receptor (CAR)-T programs from Factor Bioscience Inc. and its affiliates (collectively, "Factor") in an all-stock transaction (the "Proposed Transaction"). The Proposed Transaction is expected to close in early 2026, subject to necessary stockholder approvals and satisfaction of closing conditions (the "Closing").

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The Proposed Transaction will expand and further diversify Tempest’s existing clinical-stage pipeline, with the acquisition of the first clinical-stage CD19/BCMA parallel structured dual-CAR T specifically designed to target patients with extramedullary disease (EMD), which we are referring to as TPST-2003. In addition, the Company expects that existing cash at Closing and an investment commitment from Factor will support the Company’s planned operations to mid 2027, including through potential key development and data milestones in 2026 and 2027.

Key Takeaways:

Subject to stockholder approval and satisfaction of closing conditions, the Proposed Transaction will both further diversify Tempest’s pipeline and extend the Company’s runway to mid 2027, potentially through value-creating milestones
Tempest plans to pursue business development discussions or an additional financing to advance the pivotal development of amezalpat (TPST-1120) in first-line liver cancer ("HCC")
TPST-2003: dual CD19/BCMA CAR-T program
Phase 1 complete in patients with relapsed multiple myeloma ("rrMM"), with data expected in 2026 and a biologics license application ("BLA") in China planned for 2027
Phase 1 currently enrolling patients with POEMs syndrome, with data expected in 2027 and a BLA in China planned for 2028
Tempest will have global rights to TPST-2003 outside of China, India, Turkey and Russia, and plans to pursue a potential registrational study in rrMM in the U.S. starting in 2027
Data from Chinese pivotal study expected to validate probability of success for Tempest program, and rights will include the right to reference data generated in support of the planned China BLA
Tempest expects a Phase 2 study of TPST-1495 in familial adenomatous polyposis ("FAP") to enroll the first patient in 2026 and to be funded by the National Cancer Institute and operationalized by the Cancer Prevention Clinical Trials Network
Plan to continue the development of additional new preclinical and research-stage pipeline programs:
TPST-2206: dual-targeting CD70/CD70 CAR-T for renal cell carcinoma
TPST-3003: allogeneic dual-targeting CD19/BCMA
TPST-3206: allogeneic dual-targeting CD70/CD70
Tempest will issue 8,268,495 shares of its common stock, par value $0.001 per share ("Common Stock"), to an affiliate of Factor, equal to 65% of the outstanding shares of Common Stock, inclusive of newly issued shares, as of November 19, 2025.
Existing Tempest stockholders will be entitled to receive one (1) common stock warrant for every share of Common Stock held and outstanding at a date immediately prior to the Closing (the "Warrants"). The Warrants will be immediately exercisable with an initial exercise price equal to $18.48 and will expire five years from the issuance date.
Existing cash at Closing and an investment commitment from Factor is expected to provide a runway to mid 2027 and potentially through key data milestones.
Upon Closing, Matt Angel, Ph.D. will become president and chief executive officer ("CEO") of Tempest and current Tempest president and CEO Stephen Brady will become Chairman of the Company’s board of directors.
"The Proposed Transaction will result in an even more diversified portfolio that we believe provides stockholders with new opportunity for value creation and patients with new potential therapies," said Stephen Brady, president and chief executive officer of Tempest. "With the new funding support, Tempest has increased its opportunity to realize potential value creating milestones in the midst of this prolonged challenging market."

Dr. Angel added, "I echo Steve’s sentiments and share in the vision to bring innovative therapies to patients with cancer. I believe there is significant potential to be realized in combining these programs and look forward to working with the Tempest team to bring these programs forward for the benefit of patients."

Matt Angel, Ph.D.

Dr. Matt Angel is an experienced biotechnology executive with expertise in leading lean cell therapy companies. Dr. Angel led Brooklyn Immunotherapeutics (Nasdaq: BTX) as CEO from 2022-2023, successfully restructuring the company and extending the company’s runway in a challenging market environment. Dr. Angel has led Factor Bioscience Inc. as co-founder and CEO since 2011 and is co-founder of cell therapy companies Novellus Therapeutics (founded 2014; sold 2021) and Exacis Biotherapeutics (founded 2020; sold 2023). Dr. Angel has deep expertise in cell therapy development and intellectual property protection and licensing. Dr. Angel is also experienced in assembling and managing multidisciplinary teams. A pioneer in cell engineering technology, Dr. Angel is a prolific inventor with more than 150 patents covering mRNA, nucleic acid delivery, gene editing, and cell reprogramming technologies. Dr. Angel received his Ph.D. from the Massachusetts Institute of Technology, where he published seminal discoveries in the then-nascent field of mRNA.

Approvals and Timing

The board of directors of Tempest has unanimously approved the Proposed Transaction and intends to recommend that Tempest stockholders vote to adopt the asset purchase agreement and the related issuance of Common Stock with respect to the Proposed Transaction at a meeting of stockholders.

The Proposed Transaction is conditioned upon approval of the holders of a majority of the outstanding shares of Common Stock of Tempest entitled to vote to adopt the asset purchase agreement with respect to the Proposed Transaction.

Completion of the transaction is expected in early 2026, subject to the approval of Tempest stockholders and the satisfaction of other customary closing conditions.

Advisors

MTS Health Partners, L.P. is serving as financial advisor to Tempest, and Cooley LLP is serving as legal advisor. In addition, MTS Securities, LLC (an affiliate of MTS Health Partners, L.P.) provided an opinion to the board of directors of Tempest regarding the fairness of the purchase price to be paid by Tempest to Factor in connection with the Proposed Transaction, subject to the qualifications and limitations set forth therein.

(Press release, Tempest Therapeutics, NOV 19, 2025, View Source [SID1234660094])

On November 19, 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 it has executed a 4-month extension of its collaboration with The Scripps Research Institute ("Scripps Research") and the lab of Dr. Alexey Stepanov, Institute Investigator at Scripps Research effective November 1, 2025, to advance the development of the Company’s research and development program evaluating the combination of systemic DNase I and CAR T-cell therapies.

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Xenetic’s systemic DNase I candidate, XBIO-015, is currently in preclinical development in combination with CAR-T cell therapy for both hematologic and solid tumors. Studies conducted by Dr. Stepanov and his lab at Scripps Research using lymphoma, metastatic melanoma and leukemia models have shown that co-administration of DNase I with CAR-T cells significantly reduces tumor burden, decreases metastatic lesions, and markedly extends survival compared to CAR-T cell monotherapy. Importantly, systemic DNase I-mediated degrading of neutrophil extracellular traps (NETs) enhances CAR-T cell efficacy, increasing the infiltration of both CAR-T cells and endogenous T cells into tumors and by mitigating the immunosuppressive tumor microenvironment (TME).

"Dr. Stepanov and the Scripps Research team continue to be valued partners, and we are pleased to once again extend our collaboration with them to further explore the full potential of our DNase-based oncology platform. The data generated to date continues to be encouraging and warrants further evaluations. The expertise and dedication of the Scripps Research team to this program further validates our belief in DNase I to improve therapeutic responses in patients undergoing CAR-T cell therapy and we look forward to continued collaboration and innovation together," 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.

(Press release, Xenetic Biosciences, NOV 19, 2025, https://ir.xeneticbio.com/news/detail/173/xenetic-biosciences-inc-extends-research-and-development-collaboration-with-institute-investigator-at-scripps-research-to-advance-dnase-platform [SID1234660095])