On January 4, 2024 Adicet Bio, Inc. (Nasdaq: ACET), a clinical stage biotechnology company discovering and developing allogeneic gamma delta T cell therapies for cancer and autoimmune diseases, reported corporate updates and highlighted upcoming priorities for its pipeline programs in 2024 (Press release, Adicet Bio, JAN 4, 2024, View Source [SID1234638999]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"In 2024, we aim to make significant strides across our pipeline of differentiated gamma delta T cell therapies through our strategic and disciplined approach," said Chen Schor, President and Chief Executive Officer at Adicet Bio. "The U.S. FDA’s IND clearance of ADI-001 in lupus nephritis marks an important milestone in maximizing the ADI-001 opportunity in the autoimmune therapeutic category that we believe it is ideally suited to address. Clinical data for ADI-001 have demonstrated B-cell depletion that mirrors the B cell depletion by autologous alpha-beta CAR T in academic clinical studies in systemic lupus erythematosus, systemic sclerosis, and idiopathic inflammatory myopathy patients. Given that gamma delta 1 T cells preferentially traffic to organs and tissues, ADI-001 is designed to target and deplete B cells in the periphery, secondary lymphoid organs, kidneys, and other organs, which is highly desirable in autoimmune diseases. ADI-001’s off-the-shelf availability and the favorable safety profile provide the potential for outpatient administration."

Mr. Schor continued: "Our internal research and development efforts are focused in areas where we believe we have a high probability of success and opportunity for significant differentiation. In our ongoing Phase 1 clinical trial of ADI-001 in relapsed or refractory NHL, we have decided to focus our current patient enrollment on the MCL population, which demonstrated the greatest clinical benefit in our June 2023 clinical update. With projected cash runway into the second half of 2025, multiple upcoming milestones, and a disciplined approach, we believe we are well-positioned to advance our pipeline of allogeneic T cell therapy candidates to address substantial unmet needs in oncology and autoimmune diseases."

Program Updates and Expected Milestones for 2024

ADI-001 is an investigational allogeneic gamma delta CAR T cell therapy targeting CD20 for the potential treatment of relapsed or refractory B-cell non-Hodgkin’s Lymphoma (NHL) and autoimmune diseases.

Autoimmune diseases

IND cleared for lupus nephritis. In December 2023, the FDA cleared Adicet’s IND application for ADI-001 in lupus nephritis.
Initiate Phase 1 clinical trial of ADI-001 for the treatment of lupus nephritis in the second quarter of 2024. The Company plans to initiate a Phase 1 clinical trial to assess the safety and efficacy of ADI-001 in lupus nephritis and may provide a clinical update from the trial in the second half of 2024. Adicet expects to expand into additional autoimmune indications in the near future.
Hematologic malignancies

Focus enrollment on MCL patients in ongoing Phase 1 GLEAN study. Adicet will focus on the MCL patient population in the ongoing Phase 1 GLEAN study (at dose level 4), which experienced the greatest clinical benefit in the June 2023 update. While these were early data, an 80% CR rate and 60% 6-month CR rate in late line MCL patients were reported in the June 2023 clinical update, Cmax and exposure by area under the curve (AUC) exceeded that of approved autologous CD19 CAR T therapies, and a favorable safety profile was observed with no significant risk of cytokine release syndrome, immune effector cell associated neurotoxicity syndrome or T-cell malignancies. These initial clinical results, coupled with the potential to dose off-the-shelf in a community setting, support ADI-001 as a potentially attractive therapy for MCL patients. The Company is evaluating the option of advancing ADI-001 to a potentially pivotal study in MCL patients under an accelerated approval pathway.
The Company remains on track to provide an ADI-001 clinical update in the second half of 2024.
ADI-270 is an investigational allogeneic gamma delta CAR T cell therapy targeting CD70 via the CD27-ligand for the treatment of renal cell carcinoma with potential in other solid tumor indications. ADI-270 is designed to home to solid tumors, with a highly specific targeting moiety for CD70 and an armoring technology of TGF beta dominant- negative receptor to address immunosuppressive factors in the tumor microenvironment. Building on gamma delta 1 tissue tropism to solid tumors and three mechanisms of anti-tumor activity (CAR, innate and adaptive), CAR gamma delta 1 T cells may be well positioned to address solid tumors.

Renal cell carcinoma

Plan to file IND for ADI-270 in 2Q 2024. Following positive feedback from a pre-IND meeting with the FDA, the Company remains on track to file an IND application for ADI-270 in the second quarter of 2024.
Financial Outlook

The Company expects cash and cash equivalents on hand as of December 31, 2023, to enable funding for current and planned operations into the second half of 2025.
Webcast/ Conference Call Information

The live webcast of the presentation can be accessed by registering under "Presentations & Events" in the investors section of the Company’s website at View Source Upon registration, all participants will receive a confirmation email with a unique passcode to provide access to the webcast event. To participate via telephone, please join by dialing 888-788-0099 (domestic) or 312-626-6799 (international) and referencing the conference ID 918 2940 8885. An archived replay will be available for 30 days following the presentation. The archived webcast will be available on the Company’s website beginning approximately two hours after the event.

On January 4, 2024 MOMA Therapeutics, a biotechnology company focused on identifying and targeting highly dynamic, difficult to drug targets in cancer and other diseases, reported a strategic collaboration and licensing agreement with Roche (SIX: RO, ROG; OTCQX: RHHBY) (Press release, MOMA Therapeutics, JAN 4, 2024, View Source [SID1234638998]). This partnership provides Roche with access to MOMA’s proprietary KnowledgeBase platform for the identification and prosecution of a certain number of novel drug targets involved in promoting cancer cell growth and survival.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

MOMA’s KnowledgeBase comprises integrated structure-function capabilities, advanced lead-finding technologies and computation-enabled lead optimization. It was built upon the concept that functionally related targets lacking sequence homology still possess three dimensional structural motifs that can be exploited to produce highly impactful therapies. To date, MOMA has utilized this bespoke platform to accelerate drug discovery in the ATPase target class, a class with a high number of genetically validated targets for which industry efforts to identify therapeutically viable drugs have been hampered by the extent of dynamic protein motion.

"Given its deep expertise and global footprint in oncology, Roche represents an ideal collaborator with whom to further advance the application of MOMA’s platform in a way that impacts patients’ lives. The vision for this collaboration was crafted jointly with Roche to enable each party to bring its strengths in pursuit of this shared goal. It also contributes to the long-term sustainability of MOMA’s core focus as we advance our rich pipeline of precision oncology programs to the clinic," said Asit Parikh, M.D., Ph.D., chief executive officer of MOMA.

Through the collaboration, MOMA will receive $66 million as an upfront cash payment and is also eligible to receive discovery, development, and commercialization milestone payments potentially exceeding US$2 billion, as well as tiered royalties. MOMA will be primarily responsible for all activities for selected targets through to development candidate confirmation, whereas Roche will be responsible for IND-enabling activities and clinical development and commercialization. Additionally, if multiple collaboration assets reach pivotal clinical studies, MOMA will receive a right to co-fund late-stage development of one product in exchange for increased royalties in the US on this product.

"We are excited to join forces with MOMA, combining our leadership in oncology with MOMA’s deep expertise in drug discovery for difficult-to-drug and novel targets in oncology. The broader field of cancer dependencies is of high importance for Roche and we are looking forward to further deepening our knowledge and discovering novel targets involved in cancer cell growth and survival leveraging MOMA’s innovative platform," said James Sabry, M.D., Ph.D., global head of pharma partnering, Roche.

"It is exciting to utilize our industry-leading knowledge in how to identify and drug highly dynamic proteins to deliver on a breadth of discovery programs in partnership with Roche," added Peter Hammerman, M.D., Ph.D., chief scientific officer and head of development at MOMA. "Along with bringing two MOMA-owned high-impact programs to the clinic next year, we are making exciting progress towards our goal of addressing key unmet needs for patients living with advanced cancer."

On January 4, 2024 Avistone Biotechnology Co., Ltd. (also referred to as Avistone Biotechnology or Avistone), an innovative biotechnology company focused on precision oncology therapeutics, reported that they had recently completed their Series B financing of 1 billion Chinese yuan (~$140 million USD) (Press release, Avistone Pharmaceuticals, JAN 4, 2024, View Source [SID1234638997]). The Series B financing was jointly led by SDIC CS Capital and IDG Capital, with participation from Yanchuang Capital and Cathay Capital. Existing shareholder Bain Capital continues to make additional investments.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

This round of financing will be used to support clinical research and development of the Avistone pipeline, including both drug monotherapy studies and internal combinations; to accelerate the screening of new molecules; to support clinical studies and expansion in the United States of America; and to support commercialization of PLB1001 (Vebreltinib) in China. In China, Avistone has established a commercial sales and marketing team covering 25 provinces, nearly 1,000 hospitals, and hundreds of commercial companies and retail outlets.

Dr. Hepeng Shi, founder, chairman and CEO of Avistone Biotechnology, said: "We thank our Series B investors for trusting and investing in Avistone. This very important financing will support the commercialization of our recently approved molecule, PLB1001 (Vebreltinib), in MET Exon 14 Skipping Non-Small Cell Lung Cancer (NSCLC) and will provide funding for our pipeline. We will continue to pursue our vision to become a leading biotechnology company with a deep pipeline and focus on innovation. We aspire to be highly trusted by the patients and families that we serve along with the physicians, practitioners, and scientists that we work with."

SDIC states: "We are pleased to lead the B-round financing for Avistone. The Company has demonstrated impressive execution capabilities and has led effective translational medical work. We firmly believe that the company will continue to produce more clinically advanced innovative products in the future. We are committed to collaborating closely with the Avistone team to foster the company’s growth, ultimately benefiting patients and contributing to the advancement of China’s innovative pharmaceutical industry."

IDG Capital noted that, "We believe that the demand for better products is a prevailing trend in the biopharmaceutical industry, and Avistone has consistently aimed for and practiced this goal. Dr. Shi’s team swiftly achieved breakthroughs from 0 to 1 in product development, showcasing strong execution and product layout capabilities. Additionally, we have high expectations for Avistone’s outstanding commercialization capabilities. We believe that in the future, Avistone can achieve more innovative breakthroughs, and IDG Capital is committed to ongoing support, contributing to the advancement of the innovative pharmaceutical industry alongside Avistone."

Jonathan Zhu, Partner and Co-Head of Asia Private Equity at Bain Capital, expressed that "We are delighted to witness Avistone’s breakthroughs in targeted oncology drug development, positioning itself as a leading domestic innovative pharmaceutical enterprise with successful ventures into Class 1 innovative drugs. We have observed the growth and development of Avistone and have strong confidence in the company’s research and development capabilities, execution efficiency, and pipeline layout strategy. Our continued investment in Avistone underscores our belief in Dr. Shi’s leadership and his team’s ability to efficiently develop groundbreaking innovative biopharmaceuticals. This establishes them as a pioneering platform for tumor-targeted drug innovation rooted in China and globally oriented."

On January 4, 2024 Debiopharm (www.debiopharm.com), a privately-owned, Swiss-based biopharmaceutical company aiming to establish tomorrow’s standards of care to cure cancer and infectious diseases, reported that it has entered into a clinical study and collaboration agreement with Repare Therapeutics Inc. ("Repare") (Nasdaq: RPTX), a leading clinical-stage precision oncology company (Press release, Debiopharm, JAN 4, 2024, View Source [SID1234638995]). This clinical collaboration aims to explore the synergy between Debio 0123, a potential best-in-class, brain-penetrant, and highly selective WEE1 inhibitor, and lunresertib, a first-in-class, selective and potent oral, small molecule inhibitor of PKMYT1 with demonstrated anticancer activity.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"We are delighted to enter into this clinical collaboration with Repare, the leader in PKMYT1 inhibition, to reinforce our commitment to the DDR space with our potential best-in-class WEE1 inhibitor. We believe this synthetic lethality approach will bring an innovative precision medicine therapy to patients"

Post this
Under the clinical study and collaboration agreement, the combination of lunresertib and Debio 0123 will be evaluated in a new arm of Repare’s ongoing global MYTHIC study (NCT04855656) under Repare’s sponsorship. The Phase 1/1b clinical trial is anticipated to initiate in the first half of 2024. Debiopharm and Repare will collaborate on the design of the trial arm for the development of the combination and will share all costs equally. Debiopharm and Repare will each supply their respective drugs, and each retain all commercial rights to their respective compounds, including as monotherapy or as combination therapies.

"We are delighted to enter into this clinical collaboration with Repare, the leader in PKMYT1 inhibition, to reinforce our commitment to the DDR space with our potential best-in-class WEE1 inhibitor. We believe this synthetic lethality approach will bring an innovative precision medicine therapy to patients," said Bertrand Ducrey, CEO of Debiopharm. "This is the first time that Debiopharm has initiated a collaboration to combine two investigational compounds, demonstrating our excitement by the potential of this therapeutic approach in hard-to-treat cancers."

At the AACR (Free AACR Whitepaper)-NCI-EORTC conference held in Boston in October 2023, Repare presented data showing that the combination of lunresertib and Debio 0123 is highly synergistic, and drives rapid and deep tumor regressions (Gallo et al., Poster #A023). Unpublished data independently generated by Debiopharm confirmed the dramatic synergy of the Debio 0123/lunresertib combination in vivo, further supporting the rationale for this clinical collaboration. In addition, several recent preclinical studies published by Repare and its collaborators have demonstrated proof-of-concept for the combination of WEE1 and PKMYT1 inhibition in relevant cancer cell lines and animal models of cancer (Sokhi et al. "Investigating Wee1 and Myt1 combined inhibition as a potential cancer therapeutic strategy", AACR (Free AACR Whitepaper) 2023, Poster #5511; Benada et al., 2023).

"Combining with Debiopharm’s highly selective WEE1 inhibitor is the ideal strategy to further extend our leadership in PKMYT1 inhibitor development," said Lloyd M. Segal, CEO of Repare. "The compelling mechanistic rationale and preclinical data Repare and Debiopharm have each generated for this combination give us confidence in its potential to deliver transformative benefit to patients with high unmet medical need."

On January 4, 2024 Poseida Therapeutics, Inc. (Nasdaq: PSTX), a clinical-stage cell and gene therapy company advancing a new class of treatments for patients with cancer and rare diseases, reported recent progress across the company’s cell and gene therapy portfolio and provided updates on anticipated upcoming milestones (Press release, Poseida Therapeutics, JAN 4, 2024, View Source [SID1234638994]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"In 2023, we made significant progress in delivering on the promise of our pipeline of allogeneic cell therapies through both substantial manufacturing advancements and compelling clinical data. At the ASH (Free ASH Whitepaper) Annual Meeting, we were thrilled to highlight the ability of P-BCMA-ALLO1, our TSCM-rich CAR-T therapy for multiple myeloma, to offer a compelling emerging efficacy and safety profile that we believe will be competitive with autologous cell therapies and bispecific antibodies, and to treat patients without lengthy waiting times," said Kristin Yarema, Ph.D., President and Chief Executive Officer of the Company. "In parallel, we expanded our partnership with Roche, accelerating the expected timing of achievement and increasing the certainty of certain milestones as well as advancing programs at all stages in the Roche collaboration. Notably, we cleared the IND for P-CD19CD20-ALLO1, which we believe is the first known dual allogeneic CAR-T directed against CD19 and CD20. In our non-viral gene therapy portfolio, we are advancing P-FVIII-101 as a potentially durable treatment for Hemophilia A and believe that the recent preclinical data presented at ASH (Free ASH Whitepaper) continue to support our liver-targeted non-viral delivery platform. Together with our strong financial position and bolstered by our robust business development and partnership activity, we believe we are well positioned for success in 2024."

"As we work to build on this momentum in 2024, we plan to report interim Phase 1 data in both our BCMA and MUC1C programs as well as dose the first patient in our allogeneic CD19CD20 dual CAR program targeting B-cell malignancies, which is partnered with Roche. We also expect to advance IND-enabling studies directed toward our wholly-owned allogeneic PSMA program in prostate cancer. In our gene therapy portfolio, we look forward to providing a comprehensive strategic update at our upcoming gene therapy-specific R&D Day in April, as we continue advancing our non-viral DNA delivery platform to unlock potential for genetic diseases. We believe we are entering a new era of cell and gene therapies, and I am thrilled to step into the role of President and CEO of Poseida at this transformative moment."

Program Highlights

Cell Therapy Programs

BCMA Program
P-BCMA-ALLO1 is a potential first-in-class allogeneic, TSCM-rich CAR-T product candidate being developed to target B-cell maturation antigen (BCMA) for the treatment of relapsed/refractory multiple myeloma (R/R MM) in partnership with Roche. The Company is currently evaluating P-BCMA-ALLO1 in a Phase 1 clinical trial and recently shared positive early safety and preliminary efficacy data at the 65th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition in December 2023.

Data highlighted at the meeting showed that P-BCMA-ALLO1 was a well-tolerated off-the-shelf therapy with a favorable emerging safety profile, delivered to 100% of patients in the intent-to-treat population with no use of bridging chemotherapy or other anti-myeloma bridging therapies. There were no cases of GvHD or dose-limiting toxicities and low incidences of CRS and neurotoxicity observed (all ≤ Grade 2). The data showed an 82% overall response rate (ORR) and deep clinical responses, including stringent complete responses (sCRs) in MRD-negative patients, from the off-the-shelf, allogeneic BCMA-targeted CAR-T in heavily pretreated patients in study arms receiving adequate lymphodepletion. Of those patients, a 100% ORR was seen in patients who were not previously treated with a BCMA-targeted bispecific T cell-engaging antibody. The median time from study enrollment to start of lymphodepletion chemotherapy was 1 day and was 7 days to P-BCMA-ALLO1 infusion. Preliminary data show allogeneic TSCM-rich CAR-T cells trafficking to bone marrow, differentiating to cell-killing effector T cells and persisting at least 6 weeks after treatment, which supports the hypothesis of cell persistence at tumor-relevant sites. At the time of data cutoff, 8 of 9 responding patients were still in clinical response.

In 2024, Poseida plans to continue development of P-BCMA-ALLO1 in partnership with Roche. This includes continuing the strong enrollment in the Phase 1 study, refinement of dosing regimen for both cell dose and lymphodepletion chemotherapy, sharing additional details on clinical trial expansion strategies and continuing product supply efforts. The Company plans to present additional clinical data updates for P-BCMA-ALLO1 at scientific meetings in 2024, subject to coordination with Roche.

CD19CD20 Program
P-CD19CD20-ALLO1 is an allogeneic, TSCM-rich CAR-T product being developed to target B-cell malignancies in partnership with Roche. P-CD19CD20-ALLO1 is the Company’s first dual CAR program and contains two fully functional CAR molecules to target cells that express either CD19 or CD20 or both. The Company believes P-CD19CD20-ALLO1 is the first known dual allogeneic CAR-T directed against CD19 and CD20 to receive IND clearance from the FDA. The Company expects to dose the first patient in the Phase 1 trial of P-CD19CD20-ALLO1 for B-cell malignancies in early 2024 and provide a data update later in the year, subject to coordination with Roche.

MUC1C Program
P-MUC1C-ALLO1 is an allogeneic, TSCM-rich CAR-T product candidate targeting the C-terminal domain of the mucin-1 protein (MUC1C), which is prevalent in solid tumors of epithelial origin, including breast, ovarian, and multiple other cancers. The Company is currently evaluating P-MUC1C-ALLO1 in a Phase 1 clinical trial with a basket study design. Building on learnings from the allogeneic BCMA CAR-T program, the Company is evaluating multiple dosing strategies, including higher lymphodepletion, cell dose, and schedule in its MUC1C program. Poseida plans to provide a data update at a scientific meeting in the first half of 2024.

PSMA Program
P-PSMA-ALLO1 is an allogeneic CAR-T product candidate targeting prostate-specific membrane antigen, or PSMA, to treat prostate cancer. This allogeneic program utilizes VH-based binding technology, similar to the approach used in the Company’s P-BCMA-ALLO1 program, but targeting PSMA. When compared to the previous autologous PSMA program that used a Centyrin binder, in preclinical models, enhanced anti-tumor activity was observed using this newer binder. Based upon progress and learnings from its autologous P-PSMA-101-001 clinical trial and across its allogenic platform, the Company plans to advance IND-enabling work for P-PSMA-ALLO1 in 2024.

Early Stage Research
The Company plans to continue early pipeline research activities and advance IND-enabling work for other allogeneic pipeline programs, including exploring opportunities in autoimmune disease.

Gene Therapy Programs

At its Gene Therapy R&D Day event in April 2024, the Company plans to share updates on its programs and outcomes from its strategic review process.

FVIII Program
The Company is advancing its P-FVIII-101 preclinical program, a fully non-viral liver-directed gene therapy combining Poseida’s proprietary piggyBac DNA Delivery System with nanoparticle delivery for the treatment of Hemophilia A. The Company recently presented preclinical data from this program at the ASH (Free ASH Whitepaper) Annual Meeting in December 2023, demonstrating the capabilities of the piggyBac DNA insertion system and non-viral approach in providing stable Factor VIII transgene expression, along with the potential for redosing. The P-FVIII-101 program is among the programs advanced through the Company’s former partnership with Takeda and Poseida received full rights back after Takeda’s change in strategy away from gene therapy and rare disease.

OTC Program
P-OTC-101 is a liver-directed gene therapy for the treatment of urea cycle disease caused by congenital mutations in the ornithine transcarbamylase (OTC) gene. The Company is developing the P-OTC-101 program utilizing a hybrid delivery system (AAV+LNP) and working on an updated timeline for the program. P-OTC-101 received orphan drug designation from the FDA in July 2023.

PAH Program
P-PAH-101 is a liver-directed gene therapy for the treatment of Phenylketonuria (PKU), an inherited genetic disorder caused by mutations in the phenylalanine hydroxylase (PAH) gene resulting in a buildup of phenylalanine in the body. The Company is developing P-PAH-101 program utilizing a hybrid system (AAV+LNP) and is currently in preclinical development.

Other Business Highlights

Fully Operationalized Internal Manufacturing Capabilities
Poseida has made substantial advancements in its allogeneic cell therapy manufacturing platform and capabilities. In 2023, Poseida established a fully internal clinical manufacturing capability which is now supplying all GMP products for all of its clinical trials across three programs. In addition, the Company has achieved yield improvements through optimization of unit operations, as described at the CAR-TCR Summit in September 2023, capable of delivering cell yields supporting up to 100+ doses per manufacturing run depending upon cell dose.

In 2024, the Company plans to continue to invest in its allogeneic platform for TSCM-rich CAR-T, including proprietary non-viral technologies, and will continue to refine and improve its manufacturing processes in ways that will potentially further increase product yield generally.

Partnerships and Collaborations
In August 2023 the Company announced a $50 million strategic investment by Astellas and granted Astellas certain strategic rights, further validating Poseida’s suite of genetic engineering technologies and its allogeneic T cell platform.

Poseida continues to develop allogeneic CAR-T therapies targeting hematological malignancies in partnership with Roche. The Company announced in November 2023 that, based upon substantial progress in its P-BCMA-ALLO1 and P-CD19CD20-ALLO1 programs, certain payments as well as the expected timing of achievement of upcoming milestones in programs have been accelerated to reflect progress in the programs and better align with expected upcoming further clinical developments and manufacturing needs and timelines. As a result of this progress, the Company expects to receive certain payments sooner and/or with more certainty than originally anticipated.

The Company continues to explore potential strategic and business development options for its technology platforms and gene therapy programs, as well as other potential opportunities in cell therapy.

Poseida R&D Days
In recognition of its continued development and growth, and to highlight its proprietary platform technologies and preclinical research in 2024, the Company plans to hold two R&D Days focusing on gene therapy and cell therapy respectively.

Poseida will hold an R&D Day focusing on gene therapy on April 17, 2024, when the Company plans to provide an update on its strategic review of its gene therapy and gene editing programs, as well as updates on its pipeline and focus areas. An R&D Day focusing on cell therapy will be hosted in the second half of 2024.

Organization

Kristin Yarema, Ph.D., has been appointed to the Company’s Board of Directors, effective January 1st, 2024.

Cash Position and Runway

As previously announced, Poseida expects that its cash, cash equivalents and short-term investments together with the remaining near-term milestones and other payments from Roche and Astellas will be sufficient to fund operations into the second half of 2025. This cash runway reflects financial prudence but has mainly been driven through business development and partnership activity, for which Poseida continues to be well positioned.