PSTX Poseida Therapeutics Inc.

6.85
-0.33  -5%
Previous Close 7.18
Open 7.09
52 Week Low 6.2
52 Week High 13.98
Market Cap $428,168,011
Shares 62,506,279
Float 26,468,735
Enterprise Value $311,112,083
Volume 108,644
Av. Daily Volume 210,477
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Upcoming Catalysts

Drug Stage Catalyst Date
P-BCMA-101
Multiple myeloma
Phase 1/2
Phase 1/2
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P-PSMA-101
metastatic castration-resistant prostate cancer (mCRPC)
Phase 1
Phase 1
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Drug Pipeline

Drug Stage Notes
P-MUC1C-ALLO1
Solid tumors
Phase 1
Phase 1
Phase 1 trial to be initiated by end of 2021.
P-BCMA-ALLO1
Multiple myeloma
Phase 1
Phase 1
Phase 1 trial to be begin dosing late 2021.

Latest News

  1. SAN DIEGO, Nov. 9, 2021 /PRNewswire/ -- Poseida Therapeutics, Inc. (NASDAQ:PSTX), a clinical-stage biopharmaceutical company utilizing proprietary genetic engineering platform technologies to create cell and gene therapeutics with the capacity to cure, today announced program updates and financial results for the third quarter ended September 30, 2021.

    "The last quarter saw continued progress as Poseida reached multiple key strategic milestones including FDA clearance of our first fully allogeneic CAR-T IND for P-BCMA-ALLO1, the presentation of strong CAR-T data in a solid tumor indication with our P-PSMA-101 program and, shortly after the quarter, the announcement of a strategic collaboration with Takeda focused on non-viral in vivo gene therapy programs utilizing our platform technologies," said Eric Ostertag, M.D., Ph.D., Chief Executive Officer of Poseida.

    "The initiation of our P-BCMA-ALLO1 clinical trial represents the beginning of a long-planned strategic transition to what we believe is the 'holy grail' of cell therapy for oncology, a fully allogeneic CAR-T with a fully humanized heavy chain BCMA binder and a high percentage of TSCM cells which we believe are the key to success," continued Ostertag. "While we believe the P-BCMA-101 autologous program has competitive advantages and would be approvable, one long-term strategic benefit of that program has been to inform our highly-differentiated allogeneic approach. With the P-BCMA-ALLO1 clinical program now underway and with very high confidence in our allogeneic platform, we will begin a planned wind down of P-BCMA-101."

    Program Updates

    BCMA Program

    P-BCMA-ALLO1, the Company's first fully allogeneic CAR-T product candidate, is in development for the treatment of relapsed/refractory multiple myeloma. In August of 2021, the U.S. Food and Drug Administration (FDA) cleared the Investigational New Drug (IND) application for P-BCMA-ALLO1. The IND clearance and the start-up of the Phase 1 clinical trial mark the beginning of the Company's strategic shift toward focusing on P-BCMA-ALLO1 rather than the autologous P-BCMA-101 program.

    While data in the autologous trial showed meaningful responses and a favorable safety profile, the Company's strategic focus has long been on allogeneic CAR-T therapies, leveraging the learnings of the autologous CAR-T program to provide benefits beyond those of autologous CAR-T, including a more desirable off-the-shelf product profile for future commercialization while maintaining the tolerability advantage of our autologous product candidate. P-BCMA-ALLO1 has the potential to deliver up to hundreds of doses per manufacturing run, thereby dramatically reducing both clinical trial costs and ultimately commercial product cost compared to the autologous P-BCMA-101 program.

    PSMA Program

    P-PSMA-101 is a solid tumor autologous CAR-T product candidate being developed to treat patients with metastatic castrate-resistant prostate cancer (mCRPC) currently in an ongoing Phase 1 dose escalation trial.

    In August of 2021, the Company presented preliminary data at the 6th Annual CAR-TCR Summit virtual meeting that demonstrated meaningful patient responses while maintaining a favorable safety and tolerability profile with modest overall rates of CRS and no neurotoxicity observed at low doses. An additional update on the P-PSMA-101 program is expected in the first half of 2022.

    MUC1-C Program

    P-MUC1C-ALLO1 is an allogeneic CAR-T product candidate in preclinical development with the potential to treat a wide range of solid tumors, including breast and ovarian cancers. P-MUC1C-ALLO1 is proceeding, with an anticipated IND filing and initiation of a Phase 1 clinical trial by the end of 2021.

    Liver-Directed Gene Therapy Program

    P-OTC-101 is the Company's first liver-directed gene therapy program for the in vivo treatment of urea cycle disease caused by congenital mutations in the ornithine transcarbamylase (OTC) gene, a condition characterized by high unmet medical need. The Company is currently evaluating whether to modify the P-OTC-101 program to move to the fully non-viral nanoparticle delivery system. The Company will update expected timing on program advancement once that evaluation is complete.

    Other Operational Updates and Upcoming Events

    Gene Therapy Research Collaboration with Takeda

    In October of 2021, the Company entered into a collaboration and license agreement with Takeda Pharmaceuticals USA, Inc. to utilize Poseida's proprietary genetic engineering platforms for the research and development of up to eight gene therapies.

    The collaboration will focus on developing non-viral in vivo gene therapy programs, including Poseida's Hemophilia A program. The Company will receive an upfront payment of $45.0 million, of which $5.0 million is for prepaid research. Per the agreement, Takeda will fund all ongoing partnered program research performed by Poseida. The collaboration may utilize all of Poseida's novel genetic engineering platform technologies, including the piggyBac® DNA Modification System for gene addition, the Cas-CLOVER™ Site-specific Gene Editing System for ultra-precise gene editing, biodegradable nanoparticle technologies for gene delivery and other emerging technologies. Poseida will lead research activities up to candidate selection, after which Takeda will assume responsibility for further development and commercialization.

    GMP Facility

    In the third quarter, the Company completed qualification and commenced GMP activity in its internal pilot manufacturing plant. The pilot plant is designed to support and speed the development of allogeneic product candidates including manufacturing clinical material for early-stage trials. The first product candidate to be produced out of the pilot plant will be P-MUC1C-ALLO1.

    Society for Immunotherapy of Cancer (SITC) 36th Annual Meeting

    The Company will give two virtual poster presentations at the upcoming SITC Annual Meeting, being held in Washington, D.C., and virtually November 10-14, 2021. The full abstracts were made available on the SITC website earlier today, with presentations taking place on November 12, 2021.

    63rd American Society of Hematology (ASH) Annual Meeting and Exposition 

    The Company will present data from the Company's differentiated P-BCMA-101 autologous CAR-T program including how it has informed the P-BCMA-ALLO1 allogeneic CAR-T program in a poster publication at the ASH Annual Meeting on Monday, December 13, 2021:

    Session Name: 704. Cellular Immunotherapies: Clinical: Poster III

    Presentation Time: 6:00 PM - 8:00 PM Eastern time

    Location: Georgia World Congress Center, Hall B5

    Financial Results for the Third Quarter 2021

    Research and Development Expenses

    Research and development expenses were $32.5 million for the third quarter ended September 30, 2021, compared to $27.0 million for the same period in 2020. For the nine months ended September 30, 2021, research and development expenses were $97.6 million, compared to $75.6 million for the same period in 2020. The increase was primarily due to increased stock-based compensation expense, headcount, external costs related to our preclinical programs and clinical stage programs, including the ongoing enrollment and manufacturing associated with our P-BCMA-101, P-BCMA-ALLO1 and P-PSMA-101 clinical trials, and internal costs related to facilities development.

    General and Administrative Expenses

    General and administrative expenses were $9.1 million for the third quarter ended September 30, 2021, compared to $6.5 million for the same period in 2020. General and administrative expenses were $26.3 million for the nine months ended September 30, 2021, compared to $15.6 million for the same period in 2020. The increase was primarily due to increased stock-based compensation expense, headcount, insurance costs and professional fees.

    Net Loss

    Net loss was $42.4 million and $126.4 million for the three and nine months ended September 30, 2021, respectively, and $34.4 million and $93.6 million for the three and nine months ended September 30, 2020, respectively. 

    Cash Position

    As of September 30, 2021, our cash and cash equivalents balance was $197.8 million. 

    About Poseida Therapeutics, Inc.

    Poseida Therapeutics is a clinical-stage biopharmaceutical company dedicated to utilizing our proprietary genetic engineering platform technologies to create next generation cell and gene therapeutics with the capacity to cure. We have discovered and are developing a broad portfolio of product candidates in a variety of indications based on our core proprietary platforms, including our non-viral piggyBac® DNA Delivery System, Cas-CLOVER™ Site-specific Gene Editing System and nanoparticle- and AAV-based gene delivery technologies. Our core platform technologies have utility, either alone or in combination, across many cell and gene therapeutic modalities and enable us to engineer our portfolio of product candidates that are designed to overcome the primary limitations of current generation cell and gene therapeutics. To learn more, visit www.poseida.com and connect with us on Twitter and LinkedIn.

    Forward-Looking Statements

    Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include statements regarding, among other things, the potential benefits of Poseida's technology platforms and product candidates, Poseida's plans and strategy with respect to developing its technologies and product candidates, and anticipated timelines and milestones with respect to Poseida's development programs and manufacturing activities. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. These forward-looking statements are based upon Poseida's current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, risks and uncertainties associated with development and regulatory approval of novel product candidates in the biopharmaceutical industry and the other risks described in Poseida's filings with the Securities and Exchange Commission. All forward-looking statement contained in this press release speak only as of the date on which they were made. Poseida undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law.

    Poseida Therapeutics, Inc.

    Selected Financial Data

    (Unaudited)

    (In thousands, except share and per share amounts)



    STATEMENTS OF OPERATIONS







    Three Months Ended September 30,





    Nine Months Ended

    September 30,







    2021





    2020





    2021





    2020



    Operating expenses:

































    Research and development



    $

    32,524





    $

    27,016





    $

    97,627





    $

    75,636



    General and administrative





    9,066







    6,458







    26,306







    15,553



    Total operating expenses





    41,590







    33,474







    123,933







    91,189



    Loss from operations





    (41,590)







    (33,474)







    (123,933)







    (91,189)



    Other income (expense):

































    Interest expense





    (837)







    (848)







    (2,518)







    (2,654)



    Other income (expense), net





    3







    (92)







    8







    216



    Net loss before income tax





    (42,424)







    (34,414)







    (126,443)







    (93,627)



    Income tax expense

























    Net loss



    $

    (42,424)





    $

    (34,414)





    $

    (126,443)





    $

    (93,627)



    Net loss per share, basic and diluted



    $

    (0.68)





    $

    (0.63)





    $

    (2.03)





    $

    (3.43)



    Weighted-average shares of common stock, basic and diluted





    62,298,243







    54,973,788







    62,144,595







    27,324,297



     

    SELECTED BALANCE SHEET DATA















    September 30,

    2021





    December 31,

    2020



    Cash, cash equivalents and short-term investments











    $

    197,811





    $

    309,152



    Total assets













    261,937







    371,484



    Total liabilities













    111,780







    109,516



    Total stockholders' equity













    150,157







    261,968



                   

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  2. SAN DIEGO, Nov. 9, 2021 /PRNewswire/ -- Poseida Therapeutics, Inc. (NASDAQ:PSTX), a clinical-stage biopharmaceutical company utilizing proprietary genetic engineering platform technologies to create cell and gene therapeutics with the capacity to cure, today announced the upcoming presentation of preclinical data highlighting P-BCMA-ALLO1 for the treatment of relapsed/refractory multiple myeloma and P-MUC1C-ALLO1 for the treatment of multiple solid tumor indications at the Society for Immunotherapy of Cancer 2021 Annual Meeting (SITC), being held in Washington, D.C., and virtually November 10-14, 2021.

    "We are pleased to share preclinical data for P-BCMA-ALLO1 and P-MUC1C-ALLO1, our first fully allogeneic candidates," said Devon Shedlock, Ph.D., Chief Scientific Officer, Cell Therapies at Poseida Therapeutics. "The results being shared at SITC not only demonstrate potent antitumor efficacy in preclinical models for our allogeneic product candidates, but also further validate the capabilities of our piggyBac and Cas-CLOVER technologies. Using our proprietary manufacturing process which includes our booster molecule, we have the potential to produce hundreds of patient doses from a single manufacturing run while also preserving high levels of stem cell memory T cells (TSCM), which are correlated with antitumor efficacy in the clinic. We have recently received FDA clearance on our P-BCMA-ALLO1 IND and are in the process of initiating a Phase 1 trial. We look forward to advancing our P-MUC1C-ALLO1 CAR-T candidate with an IND filing expected later this year."

    Poseida is presenting two posters, which will be on display on the SITC 2021 virtual meeting platform from 7 a.m. EST on Friday, Nov. 12, 2021 until the virtual meeting platform is closed on Jan. 9, 2022.

    Presentation Highlights:

    In the poster titled "Memory Phenotype in Allogeneic Anti-BCMA CAR-T Cell Therapy (P-BCMA-ALLO1) Correlates with In Vivo Tumor Control" (Abstract Number 147), Hubert Tseng, Ph.D., Poseida Therapeutics, will highlight:

    • Using the Company's piggyBac DNA Delivery System in combination with its Cas-CLOVER gene editing system and a proprietary "booster molecule," Poseida generated doses of P-BCMA-ALLO1 from healthy donor T cells and consistently maintain high frequency of stem cell memory T cells.
    • Cas-CLOVER was used to eliminate surface expression of both the TCR and MHC class I to make fully allogeneic CAR-T cells. In addition to the CAR molecule, piggyBac enables delivery of a selectable marker allowing the generation of a final cell product that is >95% CAR-positive.
    • P-BCMA-ALLO1 is comprised of a high frequency of TSCM. It has potent in vivo antitumor activity, which is comparable to non-edited autologous anti-BCMA CAR-T cell therapy. Expression of memory markers at both the mRNA and protein levels across individual lots significantly correlates with in vivo tumor control.
    • P-BCMA-ALLO1 is a highly potent and safe allogeneic anti-BCMA CAR with a manufacturing process that consistently maintains a TSCM phenotype, which correlates with antitumor efficacy. P-BCMA-ALLO1 has received FDA IND clearance and is advancing rapidly toward the clinic.

    In the poster titled "P-MUC1C-ALLO1: A Fully Allogeneic Stem Cell Memory T Cell CAR-T Therapy with Broad Potential in Solid Tumor" (Abstract Number 123), Yan Zhang, Ph.D., Poseida Therapeutics, will highlight:

    • P-MUC1C-ALLO1 is manufactured using Poseida's piggyBac DNA delivery system and Cas-CLOVER gene editing system to knockout both the TCR and MHC class I proteins. Poseida can generate significant doses of P-MUC1C-ALLO1 including a high-percentage of desirable TSCM cells.
    • P-MUC1C-ALLO1 displayed specificity for tumor vs normal cells: MUC1C CAR-T cells had potent cytotoxicity against tumor cells, and minimal killing of normal MUC1-C-positive human primary cells.
    • In a triple negative breast cancer xenograft model, P-MUC1C-ALLO1 eliminated established tumor cells, demonstrating robust T cell expansion in peripheral blood and maintained a favorable TSCM percentage over time.
    • P-MUC1C-ALLO1 has also shown robust efficacy in a peritoneal ovarian cancer xenograft model, eliminating established tumor cells to undetectable levels with minimal toxicity.

    About P-BCMA-ALLO1

    P-BCMA-ALLO1 is Poseida's first fully allogeneic product candidate targeting B-cell maturation antigen (BCMA) for the treatment of relapsed/refractory multiple myeloma. In in vitro and in vivo preclinical studies, P-BCMA-ALLO1 showed effective targeted cancer cell killing and cytokine secretion, with similar or superior performance in anti-tumor efficacy compared to an autologous CAR-T therapy, P-BCMA-101. Inclusion of a proprietary booster molecule in the allogeneic manufacturing process further improves expansion of gene-edited cells and may potentially enable production of hundreds of patient doses from a single manufacturing run, thereby potentially reducing the manufacturing cost per dose into the same range as that of a monoclonal antibody. In August 2021, Poseida announced that its Investigational New Drug (IND) application for P-BCMA-ALLO1 received clearance from the U.S. Food and Drug Administration (FDA).

    About P-MUC1C-ALLO1

    P-MUC1C-ALLO1 is an allogeneic CAR-T product candidate in preclinical development with the potential to treat a wide range of solid tumors derived from epithelial cells, including breast and ovarian cancers, as well as other cancers expressing a cancer-specific form of the Mucin 1 protein, or MUC1C. We have designed P-MUC1C-ALLO1 to be fully allogeneic, with genetic edits to eliminate or reduce both host-vs-graft and graft-vs-host alloreactivity. We have demonstrated the elimination of tumor cells to undetectable levels in preclinical models of breast cancer and ovarian cancer.

    About Poseida Therapeutics, Inc.

    Poseida Therapeutics is a clinical-stage biopharmaceutical company dedicated to utilizing our proprietary genetic engineering platform technologies to create next generation cell and gene therapeutics with the capacity to cure. We have discovered and are developing a broad portfolio of product candidates in a variety of indications based on our core proprietary platforms, including our non-viral piggyBac® DNA Delivery System, Cas-CLOVER™ Site-Specific Gene Editing System and biodegradable nanoparticle- and AAV-based gene delivery technologies. Our core platform technologies have utility, either alone or in combination, across many cell and gene therapeutic modalities and enable us to engineer our portfolio of product candidates that are designed to overcome the primary limitations of current generation cell and gene therapeutics. To learn more, visit www.poseida.com and connect with us on Twitter and LinkedIn.

    Forward-Looking Statement

    Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include statements regarding the clinical data presented, the potential benefits of Poseida's technology platforms and product candidates and Poseida's plans and strategy with respect to developing its technologies and product candidates. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. These forward-looking statements are based upon Poseida's current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, risks and uncertainties associated with development and regulatory approval of novel product candidates in the biopharmaceutical industry, the fact that future clinical results could be inconsistent with results observed to date and the other risks described in Poseida's filings with the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made. Poseida undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law.

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  3. SAN DIEGO, Nov. 3, 2021 /PRNewswire/ -- Poseida Therapeutics, Inc. (NASDAQ:PSTX), a clinical-stage biopharmaceutical company utilizing proprietary genetic engineering platform technologies to create cell and gene therapeutics with the capacity to cure, today announced that the Company will participate in the following upcoming virtual investor conferences:

    Stifel 2021 Virtual Healthcare Conference

    Date: Tuesday, November 16, 2021

    Time: 2:40pm ET

    Piper Sandler 33rd Annual Virtual Healthcare Conference

    Date: Monday, November 22, 2021

    Time: Pre-record available at 10:00am ET

    Webcasts will be available on the Investors & Media Section of the Poseida website, www.poseida.com.  An archived replay of each webcast will be available for approximately 30 days following each presentation. 

    About Poseida Therapeutics, Inc.

    Poseida Therapeutics is a clinical-stage biopharmaceutical company dedicated to utilizing our proprietary genetic engineering platform technologies to create next generation cell and gene therapeutics with the capacity to cure. We have discovered and are developing a broad portfolio of product candidates in a variety of indications based on our core proprietary platforms, including our non-viral piggyBac DNA Modification System, Cas-CLOVER Site-Specific Gene Editing System and biodegradable nanoparticle- and AAV-based gene delivery technologies. Our core platform technologies have utility, either alone or in combination, across many cell and gene therapeutic modalities and enable us to engineer our portfolio of product candidates that are designed to overcome the primary limitations of current generation cell and gene therapeutics. To learn more, visit www.poseida.com and connect with us on Twitter and LinkedIn.

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  4. SAN DIEGO, Oct. 13, 2021 /PRNewswire/ -- Poseida Therapeutics, Inc. (NASDAQ:PSTX), a clinical-stage biopharmaceutical company utilizing proprietary genetic engineering platform technologies to create cell and gene therapeutics with the capacity to cure, today announced appointments to new roles on its executive leadership team. Effective immediately, Johanna Mylet, C.P.A., will serve as Chief Financial Officer; Devon Shedlock, Ph.D., will become Chief Scientific Officer, Cell Therapies; Kristin Martin will assume the role of Chief People and Administration Officer; and Lisa Portale will become Senior Vice President, Regulatory Affairs.

    SAN DIEGO, Oct. 13, 2021 /PRNewswire/ -- Poseida Therapeutics, Inc. (NASDAQ:PSTX), a clinical-stage biopharmaceutical company utilizing proprietary genetic engineering platform technologies to create cell and gene therapeutics with the capacity to cure, today announced appointments to new roles on its executive leadership team. Effective immediately, Johanna Mylet, C.P.A., will serve as Chief Financial Officer; Devon Shedlock, Ph.D., will become Chief Scientific Officer, Cell Therapies; Kristin Martin will assume the role of Chief People and Administration Officer; and Lisa Portale will become Senior Vice President, Regulatory Affairs.

    "At Poseida we continue to execute on our mission to use our genetic engineering platform technology to develop single treatment cures for cancer and rare diseases. Our recently announced strategic collaboration with Takeda to pursue non-viral gene therapies based upon our technologies is an exciting and validating strategic milestone as we launch the next wave of the Company's evolution," said Eric Ostertag, M.D., Ph.D., Chief Executive Officer of Poseida Therapeutics. "In order to prepare the organization for the next stage of growth, we are announcing some internal organizational changes, and I am pleased to recognize Johanna, Devon, Kristin and Lisa for their significant contributions as they assume these expanded leadership roles at Poseida."

    Ms. Mylet joined the Company in 2015 and most recently served as Senior Vice President, Finance following Poseida's successful Series D financing and initial public offering in July 2020. Previously, Ms. Mylet was a controller at HUYA Bioscience International, and an audit manager at Grant Thornton, LLP, where she served life science companies across varying stages of development. She holds a Bachelor of Accountancy degree from the University of San Diego and is a Certified Public Accountant.

    Joining Poseida as its first employee in 2015, Dr. Shedlock was most recently Senior Vice President of Research & Development, serving as a key scientific contributor in the application of the Company's proprietary gene engineering platform technologies to develop novel cell therapy programs. He previously held positions as an adjunct assistant professor of pathology and laboratory medicine at the Perelman School of Medicine, and associate director of the T-Cell Engineering Laboratory that is part of Carl June's group, both at the University of Pennsylvania. Dr. Shedlock received his Ph.D. in Cell & Molecular Biology from the University of Pennsylvania, and a B.S. with Honors in biology from Ursinus College in Collegeville, Pennsylvania.

    Ms. Martin most recently served as Chief Human Resources Officer upon joining Poseida in 2019. Her prior experience includes that of Vice President of Human Resources, Facilities and IT at Ardea Biosciences, and previous human resources leadership roles working with research and development, operations and pharmaceutical manufacturing at Amylin Pharmaceuticals. Ms. Martin received a B.A. degree in interpersonal communication and human resource management from Bowling Green State University.

    Ms. Portale joined the Company in early 2019 as Vice President, Regulatory Affairs, providing oversight of multiple program advancements and associated interactions with federal agencies. Her prior roles include regulatory strategy and global portfolio lead for Pfizer, and in several regulatory affairs roles of increasing responsibility at Phenomix Corporation, Neurocrine Biosciences, Medtronic and Perrigo Company. She received a B.S. in Biology and Biological Sciences from Michigan State University.

    "It is an exciting time at Poseida, as we continue to execute against our strategies and expand our leadership in cell and gene therapy, including our recent strategic partnership with Takeda and the recent IND clearance for P-BCMA-ALLO1, our first allogeneic CAR-T program," said Mark Gergen, President and Chief Business Officer at Poseida. "We continue to build our capabilities as we advance our pipeline, leverage our science and platforms and develop new medicines for patients."

    About Poseida Therapeutics, Inc.

    Poseida Therapeutics is a clinical-stage biopharmaceutical company dedicated to utilizing our proprietary genetic engineering platform technologies to create next generation cell and gene therapeutics with the capacity to cure. We have discovered and are developing a broad portfolio of product candidates in a variety of indications based on our core proprietary platforms, including our non-viral piggyBac DNA Modification System, Cas-CLOVER Site-Specific Gene Editing System and biodegradable nanoparticle- and AAV-based gene delivery technologies. Our core platform technologies have utility, either alone or in combination, across many cell and gene therapeutic modalities and enable us to engineer our portfolio of product candidates that are designed to overcome the primary limitations of current generation cell and gene therapeutics. To learn more, visit www.poseida.com and connect with us on Twitter and LinkedIn.

    Forward-Looking Statement

    Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include statements regarding the clinical data presented, the potential benefits of Poseida's technology platforms and product candidates and Poseida's plans and strategy with respect to developing its technologies and product candidates. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. These forward-looking statements are based upon Poseida's current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, risks and uncertainties associated with development and regulatory approval of novel product candidates in the biopharmaceutical industry, the fact that future clinical results could be inconsistent with results observed to date and the other risks described in Poseida's filings with the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made. Poseida undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law.

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  5. SAN DIEGO, Oct. 12, 2021 /PRNewswire/ -- Poseida Therapeutics, Inc. (NASDAQ:PSTX), a clinical-stage biopharmaceutical company utilizing proprietary genetic engineering platform technologies to create cell and gene therapeutics with the capacity to cure, today announced that it has entered into a research collaboration and exclusive license agreement with Takeda Pharmaceutical Company Limited ("Takeda") to utilize Poseida's piggyBac, Cas-CLOVER, biodegradable DNA and RNA nanoparticle delivery technology and other proprietary genetic engineering platforms for the research and development of up to eight gene therapies. The collaboration will focus on developing non-viral in vivo gene therapy programs, including Poseida's Hemophilia A program.

    SAN DIEGO, Oct. 12, 2021 /PRNewswire/ -- Poseida Therapeutics, Inc. (NASDAQ:PSTX), a clinical-stage biopharmaceutical company utilizing proprietary genetic engineering platform technologies to create cell and gene therapeutics with the capacity to cure, today announced that it has entered into a research collaboration and exclusive license agreement with Takeda Pharmaceutical Company Limited ("Takeda") to utilize Poseida's piggyBac, Cas-CLOVER, biodegradable DNA and RNA nanoparticle delivery technology and other proprietary genetic engineering platforms for the research and development of up to eight gene therapies. The collaboration will focus on developing non-viral in vivo gene therapy programs, including Poseida's Hemophilia A program.

    "We are excited to partner with Takeda, a global biopharmaceutical leader whose commitment to the development of novel therapies for rare diseases complements our innovative platform technologies and robust gene therapy pipeline," said Eric Ostertag, M.D., Ph.D., Chief Executive Officer of Poseida. "Our technologies offer highly efficient gene delivery, fully integrated non-viral genome insertion and ultra-precise site-specific gene editing. Together with Takeda, we look forward to developing potential cures for a number of genetic diseases with high unmet need."

    Under the terms of the agreement, the parties will collaborate to initially develop up to six in vivo gene therapy programs utilizing Poseida's novel technology platforms including piggyBac, Cas-CLOVER and biodegradable nanoparticle technology, as well as certain emerging technologies.  Takeda also has an option to add two additional programs to the collaboration and is obligated to provide funding for all collaboration program R&D costs.

    Poseida will receive an upfront payment of $45 million and preclinical milestones that together could potentially exceed $125 million in the aggregate, if milestones for six programs are achieved. Poseida is also eligible to receive future clinical development, regulatory, and commercial milestone payments with a total potential value over the course of the partnership of up to $2.7 billion if milestones for all six programs are achieved, and up to $3.6 billion if the milestones related to the two optional programs are also achieved. Poseida will lead research activities up to candidate selection, after which Takeda will assume responsibility for further development and commercialization.

    "Poseida's differentiated platform technologies show great promise in developing non-viral in vivo gene therapies using their novel genetic engineering and delivery technologies that complement our existing collaborations," said Takeda Rare Diseases Drug Discovery Unit Head, Madhu Natarajan. "This partnership reinforces Takeda's commitment to investing in next-generation gene therapy approaches that have the potential to deliver functional cures to patients with rare genetic and hematologic diseases. We look forward to partnering with Poseida where we can apply our broad development capabilities to help progress several early stage preclinical programs."

    Poseida Therapeutics Conference Call and Webcast Information

    Poseida's management team will host a conference call and webcast at 8:00am ET today, October 12, 2021 to discuss the collaboration. The dial-in numbers for domestic and international callers are (866) 939-3921 and (678) 302-3550, respectively. The conference ID number for the call is 50242119.

    Participants may access the live webcast on the Investors & Media Section of the Poseida website, www.poseida.com. An archived replay of the webcast will be available for approximately 30 days following the event.

    About Poseida Therapeutics, Inc.

    Poseida Therapeutics is a clinical-stage biopharmaceutical company dedicated to utilizing our proprietary genetic engineering platform technologies to create next generation cell and gene therapeutics with the capacity to cure. We have discovered and are developing a broad portfolio of product candidates in a variety of indications based on our core proprietary platforms, including our non-viral piggyBac DNA Modification System, Cas-CLOVER Site-Specific Gene Editing System and biodegradable nanoparticle- and AAV-based gene delivery technologies. Our core platform technologies have utility, either alone or in combination, across many cell and gene therapeutic modalities and enable us to engineer our portfolio of product candidates that are designed to overcome the primary limitations of current generation cell and gene therapeutics. To learn more, visit www.poseida.com and connect with us on Twitter and LinkedIn.

    Forward-Looking Statement

    Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include statements regarding potential payments and activities under the collaboration agreement with Takeda, the potential benefits of Poseida's technology platforms and product candidates and Poseida's plans and strategy with respect to developing its technologies and product candidates. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. These forward-looking statements are based upon Poseida's current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, the fact that the collaboration agreement with Takeda may be terminated early, the fact that Poseida will have limited control over the efforts and resources that Takeda devotes to advancing development programs under the collaboration agreement, risks and uncertainties associated with development and regulatory approval of novel product candidates in the biopharmaceutical industry, the fact that future preclinical and clinical results could be inconsistent with results observed to date and the other risks described in Poseida's filings with the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made. Poseida undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law.

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    SOURCE Poseida Therapeutics, Inc.

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