Post by icemandios on May 12, 2021 13:34:58 GMT
Xenetic Biosciences, Inc. Reports First Quarter 2021 Financial Results
Continued Execution on Xcart™ Development Plan With Commencement of Exploratory Patient Biopsy Trial Expected To Position the Company To Conduct Ind-Enabling Studies in the United States
Licensing Partners Leveraging PolyXen® Platform Technology Continue To Make Clinical, Regulatory and Commercial Advancement
FRAMINGHAM, MA / ACCESSWIRE / May 12, 2021 / Xenetic Biosciences, Inc. (NASDAQ:XBIO) ("Xenetic" or the "Company"), a biopharmaceutical company focused on advancing XCART™, a personalized CAR T platform technology engineered to target patient- and tumor-specific neoantigens, today reported its financial results for the first quarter of 2021 and provided a corporate update.
"During the first quarter our focus remained on advancing the development of our XCART™ platform, which we believe has the potential to provide a personalized CAR T therapy targeting cancers with a patient-and tumor-specific approach. The commencement of our exploratory patient biopsy trial is a key component of our preclinical development strategy and an important step forward toward advancing into a Phase 1 study," commented Jeffrey Eisenberg, Chief Executive Officer of Xenetic.
XCARTTM Platform Technology Overview: Significantly differentiated, proprietary approach to personalized CAR T lymphoma therapy targeting tumor-specific antigens independently of CD19 or other surface antigens that are common to both normal and malignant B-cells. Lead program for Non-Hodgkin lymphoma, an area of significant unmet need, with the potential to address an initial global market opportunity of over $7 billion annually.[1]
Program Highlights:
Collaboration with Pharmsynthez and multiple academic institutions in Eastern Europe to optimize the overall XCART™ workflow, including clinical manufacturing processes, and ultimately to conduct a first in human study in B-cell Non-Hodgkin lymphoma (NHL) patients.
Research and development collaboration with Scripps Research covering design and implementation of the preclinical development program, as well as method development activities supporting process development for clinical manufacturing.
Recently commenced exploratory patient biopsy study in Eastern Europe. When sufficient experience is gained through this exploratory study, the collaborations being leveraged in the XCART™ development program may be expanded to include development and qualification of manufacturing processes for producing XCART™-designed, tumor-specific autologous CAR T cells. The work being performed under these collaborations is expected to position the Company to conduct IND-enabling studies in the United States.
Upcoming Potential Milestones
Seeking U.S. FDA INTERACT meeting.
Initiating process development for clinical CAR T manufacturing.
PolyXen® Platform Technology: Patent-protected platform technology designed for protein or peptide therapeutics, enabling next-generation biological drugs by prolonging a drug's circulating half-life and potentially improving other pharmacological properties.
Program Highlights:
Exclusive License Agreement with Takeda Pharmaceuticals Co. Ltd. ("Takeda") in the field of blood coagulation disorders.
Takeda currently has one active development program underway.
Royalty payments of approximately $0.2 million were received in the quarter ended March 31, 2021, as Takeda's sublicensee has now launched the relevant product in multiple global markets.
Company's partner, Pharmsynthez, announced positive Phase 3 trial results and filed a registration dossier in Russia to obtain approval of Epolong, a polysialylated form of human erythropoietin as a treatment for anemia in patients with chronic kidney disease.
Summary of Financial Results for First Quarter 2021
Net loss for the quarter ended March 31, 2021 was approximately $1.3 million. Research & development expenses for the three months ended March 31, 2021 increased by approximately $0.3 million, or 75.1%, to $0.6 million from $0.4 million in the comparable quarter in 2020. The increase was due to the Company's increase on spending for the XCART™ platform technology. General and administrative expenses for the three months ended March 31, 2021 and 2020 were approximately $0.9 million. Increases in consulting and employee related costs during the three months ended March 31, 2021 compared to the same period in 2020 were substantially offset by lower share-based expense and legal and accounting costs. At March 31, 2021, the Company reported working capital was approximately $10.2 million. Working capital decreased by $1.2 million from December 31, 2020 due to the Company's net loss for the three months ended March 31, 2021. The Company ended the quarter with approximately $10.0 million of cash.
About Xenetic Biosciences
Xenetic Biosciences, Inc. is a biopharmaceutical company focused on progressing XCART™, a personalized CAR T platform technology engineered to target patient- and tumor-specific neoantigens. The Company is initially advancing cell-based therapeutics targeting the unique B-cell receptor on the surface of an individual patient's malignant tumor cells for the treatment of B-cell lymphomas. XCART™ has the potential to fuel a robust pipeline of therapeutic assets targeting high-value oncology indications.
Additionally, Xenetic is leveraging PolyXen®, its proprietary drug delivery platform, by partnering with biotechnology and pharmaceutical companies. PolyXen® has demonstrated its ability to improve the half-life and other pharmacological properties of next-generation biologic drugs. The Company has an exclusive license agreement with Takeda Pharmaceuticals Co. Ltd. in the field of coagulation disorders and receives royalty payments under this agreement
Continued Execution on Xcart™ Development Plan With Commencement of Exploratory Patient Biopsy Trial Expected To Position the Company To Conduct Ind-Enabling Studies in the United States
Licensing Partners Leveraging PolyXen® Platform Technology Continue To Make Clinical, Regulatory and Commercial Advancement
FRAMINGHAM, MA / ACCESSWIRE / May 12, 2021 / Xenetic Biosciences, Inc. (NASDAQ:XBIO) ("Xenetic" or the "Company"), a biopharmaceutical company focused on advancing XCART™, a personalized CAR T platform technology engineered to target patient- and tumor-specific neoantigens, today reported its financial results for the first quarter of 2021 and provided a corporate update.
"During the first quarter our focus remained on advancing the development of our XCART™ platform, which we believe has the potential to provide a personalized CAR T therapy targeting cancers with a patient-and tumor-specific approach. The commencement of our exploratory patient biopsy trial is a key component of our preclinical development strategy and an important step forward toward advancing into a Phase 1 study," commented Jeffrey Eisenberg, Chief Executive Officer of Xenetic.
XCARTTM Platform Technology Overview: Significantly differentiated, proprietary approach to personalized CAR T lymphoma therapy targeting tumor-specific antigens independently of CD19 or other surface antigens that are common to both normal and malignant B-cells. Lead program for Non-Hodgkin lymphoma, an area of significant unmet need, with the potential to address an initial global market opportunity of over $7 billion annually.[1]
Program Highlights:
Collaboration with Pharmsynthez and multiple academic institutions in Eastern Europe to optimize the overall XCART™ workflow, including clinical manufacturing processes, and ultimately to conduct a first in human study in B-cell Non-Hodgkin lymphoma (NHL) patients.
Research and development collaboration with Scripps Research covering design and implementation of the preclinical development program, as well as method development activities supporting process development for clinical manufacturing.
Recently commenced exploratory patient biopsy study in Eastern Europe. When sufficient experience is gained through this exploratory study, the collaborations being leveraged in the XCART™ development program may be expanded to include development and qualification of manufacturing processes for producing XCART™-designed, tumor-specific autologous CAR T cells. The work being performed under these collaborations is expected to position the Company to conduct IND-enabling studies in the United States.
Upcoming Potential Milestones
Seeking U.S. FDA INTERACT meeting.
Initiating process development for clinical CAR T manufacturing.
PolyXen® Platform Technology: Patent-protected platform technology designed for protein or peptide therapeutics, enabling next-generation biological drugs by prolonging a drug's circulating half-life and potentially improving other pharmacological properties.
Program Highlights:
Exclusive License Agreement with Takeda Pharmaceuticals Co. Ltd. ("Takeda") in the field of blood coagulation disorders.
Takeda currently has one active development program underway.
Royalty payments of approximately $0.2 million were received in the quarter ended March 31, 2021, as Takeda's sublicensee has now launched the relevant product in multiple global markets.
Company's partner, Pharmsynthez, announced positive Phase 3 trial results and filed a registration dossier in Russia to obtain approval of Epolong, a polysialylated form of human erythropoietin as a treatment for anemia in patients with chronic kidney disease.
Summary of Financial Results for First Quarter 2021
Net loss for the quarter ended March 31, 2021 was approximately $1.3 million. Research & development expenses for the three months ended March 31, 2021 increased by approximately $0.3 million, or 75.1%, to $0.6 million from $0.4 million in the comparable quarter in 2020. The increase was due to the Company's increase on spending for the XCART™ platform technology. General and administrative expenses for the three months ended March 31, 2021 and 2020 were approximately $0.9 million. Increases in consulting and employee related costs during the three months ended March 31, 2021 compared to the same period in 2020 were substantially offset by lower share-based expense and legal and accounting costs. At March 31, 2021, the Company reported working capital was approximately $10.2 million. Working capital decreased by $1.2 million from December 31, 2020 due to the Company's net loss for the three months ended March 31, 2021. The Company ended the quarter with approximately $10.0 million of cash.
About Xenetic Biosciences
Xenetic Biosciences, Inc. is a biopharmaceutical company focused on progressing XCART™, a personalized CAR T platform technology engineered to target patient- and tumor-specific neoantigens. The Company is initially advancing cell-based therapeutics targeting the unique B-cell receptor on the surface of an individual patient's malignant tumor cells for the treatment of B-cell lymphomas. XCART™ has the potential to fuel a robust pipeline of therapeutic assets targeting high-value oncology indications.
Additionally, Xenetic is leveraging PolyXen®, its proprietary drug delivery platform, by partnering with biotechnology and pharmaceutical companies. PolyXen® has demonstrated its ability to improve the half-life and other pharmacological properties of next-generation biologic drugs. The Company has an exclusive license agreement with Takeda Pharmaceuticals Co. Ltd. in the field of coagulation disorders and receives royalty payments under this agreement