Poseida Therapeutics(PSTX)
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Poseida Therapeutics Named to Newsweek's List of the Top 200 America's Most Loved Workplaces for 2024
Prnewswire· 2024-10-03 20:30
Inclusion on list recognizes Poseida for employee sentiment and satisfaction SAN DIEGO, Oct. 3, 2024 /PRNewswire/ -- Poseida Therapeutics, Inc. (Nasdaq: PSTX), a clinical-stage allogeneic cell therapy and genetic medicines company advancing differentiated non-viral treatments for patients with cancer and rare diseases, today announced its inclusion in Newsweek Magazine's annual America's Top Most Loved Workplaces® list, developed by Most Loved Workplace®, a division of Best Practice Institute (BPI). "At Pos ...
Poseida Therapeutics: An Underappreciated Company Continuing To Shape Up Well In 2024
Seeking Alpha· 2024-09-09 13:16
Savushkin/E+ via Getty Images Topline Summary and Update Poseida Therapeutics (NASDAQ:PSTX) is a cell-therapy-focused biotech that I covered with some optimism back in December 2023, with the company's pipeline showing early signs of being the real deal. In particular, I was interested in their "allogeneic" engineered cell therapy approach that appeared to dodge one of the most concerning complications of a non-self bone marrow transplant: graft-versus-host disease (GVHD). Today, I want to take another look ...
Poseida Therapeutics to Present at Upcoming Investor Conferences
Prnewswire· 2024-08-29 20:05
SAN DIEGO, Aug. 29, 2024 /PRNewswire/ -- Poseida Therapeutics, Inc. (Nasdaq: PSTX), a clinical-stage allogeneic cell therapy and genetic medicines company advancing differentiated non-viral treatments for patients with cancer and rare diseases, today announced that the Company will participate in fireside chats at the following upcoming investor conferences in September: H.C. Wainwright 26th Annual Global Investment Conference Date: Monday, September 9, 2024 Time: 10:30am ET 2024 Cantor Global Healthcare Co ...
Are You Looking for a Top Momentum Pick? Why Poseida Therapeutics, Inc. (PSTX) is a Great Choice
ZACKS· 2024-07-19 17:01
Earnings Outlook Over the past two months, 1 earnings estimate moved higher compared to none lower for the full year. These revisions helped boost PSTX's consensus estimate, increasing from -$1.67 to -$1.61 in the past 60 days. Looking at the next fiscal year, 1 estimate has moved upwards while there have been no downward revisions in the same time period. Given these factors, it shouldn't be surprising that PSTX is a #2 (Buy) stock and boasts a Momentum Score of B. If you're looking for a fresh pick that's ...
Poseida Therapeutics Announces Participation in Stifel's 2024 Virtual Cell Therapy Forum
Prnewswire· 2024-07-01 20:05
Core Insights - Poseida Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on advancing differentiated allogeneic cell therapies and genetic medicines for cancer and rare diseases [3] Company Overview - The company is developing investigational allogeneic CAR-T cell therapies targeting both solid tumors and hematologic cancers, as well as in vivo genetic medicines for patients with high unmet medical needs [3] - Poseida utilizes proprietary genetic editing platforms, including the non-viral piggyBac® DNA Delivery System and Cas-CLOVER™ Site-Specific Gene Editing System, along with in-house GMP cell therapy manufacturing [3] - Strategic collaborations have been formed with Roche and Astellas to enhance the potential of cell therapies for cancer patients [3] Upcoming Events - The President and CEO, Kristin Yarema, will participate in a virtual fireside chat at the Stifel 2024 Virtual Cell Therapy Forum on July 9, 2024 [1] - A live webcast of the event will be available on Poseida's website, with a replay accessible for approximately 90 days post-presentation [2]
Poseida Therapeutics Announces Virtual 2024 Annual Meeting of Stockholders
Prnewswire· 2024-06-03 20:05
SAN DIEGO, June 3, 2024 /PRNewswire/ -- Poseida Therapeutics, Inc. (Nasdaq: PSTX), a clinical-stage allogeneic cell therapy and genetic medicines company advancing differentiated non-viral treatments for patients with cancer and rare diseases, today announced that its virtual Annual Meeting of Stockholders (the "Annual Meeting") will be held on Monday, June 17, 2024 at 1:00 p.m. PT. The Annual Meeting will be held through a live webcast. Stockholders of record at the close of business on April 18, 2024 are ...
Poseida Therapeutics(PSTX) - 2024 Q1 - Quarterly Report
2024-05-14 20:11
Washington, D.C. 20549 FORM 10-Q (Mark One) Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2024 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ________ to ________ Commission File Number: 001-39376 Poseida Therapeutics, Inc. (Exact Name of Registrant as Specified in its Charter) Del ...
Poseida Therapeutics(PSTX) - 2023 Q4 - Annual Report
2024-03-07 21:24
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM TO Commission File Number 001-39376 POSEIDA THERAPEUTICS, INC. (Exact name of Registrant as specified in its Charter) Delaware 47-2846548 (State ...
Poseida Therapeutics(PSTX) - 2023 Q4 - Annual Results
2024-03-07 21:05
[Executive Summary](index=1&type=section&id=Executive%20Summary) Poseida Therapeutics reported Q4 and FY2023 results, highlighting positive P-BCMA-ALLO1 Phase 1 data, P-CD19CD20-ALLO1 trial initiation, and gene therapy progress, with 2024 poised for key data readouts [Summary of Q4 and FY2023 Highlights](index=1&type=section&id=Summary%20of%20Q4%20and%20FY2023%20Highlights) Poseida Therapeutics reported Q4 and FY2023 results, highlighting positive P-BCMA-ALLO1 Phase 1 data, P-CD19CD20-ALLO1 trial initiation, and gene therapy progress, with 2024 poised for key data readouts - Lead asset **P-BCMA-ALLO1** Phase 1 clinical trial data presented at ASH 2023 demonstrated **82% ORR** and a favorable emerging safety and reliability profile[1](index=1&type=chunk) - Initiated clinical trial of Phase 1 **P-CD19CD20-ALLO1**, the company's first allogeneic dual CAR-T program[1](index=1&type=chunk) - **P-FVIII-101** gene therapy data presented at ASH, with a Gene Therapy R&D Day planned for April 17, 2024[1](index=1&type=chunk) - CEO Kristin Yarema stated that '2024 looks to be a breakout year for Poseida' with planned data readouts for three clinical-stage CAR-T programs[2](index=2&type=chunk) [Recent Business Accomplishments (2023)](index=1&type=section&id=Recent%20Business%20Accomplishments%20(2023)) Poseida Therapeutics achieved significant milestones in 2023, advancing its cell and gene therapy programs with positive clinical data and strategic partnerships [Cell Therapy Program Updates](index=1&type=section&id=Cell%20Therapy%20Program%20Updates) In 2023, Poseida presented positive Phase 1 P-BCMA-ALLO1 data, continued P-MUC1C-ALLO1 enrollment, and advanced Roche-partnered hematologic malignancy programs, including P-CD19CD20-ALLO1 initiation - Presented positive data from the Phase 1 study of **P-BCMA-ALLO1** in relapsed/refractory multiple myeloma (RRMM) at ASH in December 2023[3](index=3&type=chunk) - Continued enrollment in the Phase 1 clinical trial of **P-MUC1C-ALLO1** for solid tumors, exploring various dosing approaches including higher lymphodepletion[5](index=5&type=chunk) - Advanced programs within hematologic malignancies in partnership with Roche, with expected acceleration of milestones resulting in a **$30 million payment** in Q1 2024[5](index=5&type=chunk) [P-BCMA-ALLO1 (Multiple Myeloma)](index=1&type=section&id=P-BCMA-ALLO1%20(Multiple%20Myeloma)) The P-BCMA-ALLO1 Phase 1 trial demonstrated high overall response rates and a favorable safety profile in heavily pretreated multiple myeloma patients - **82% Overall Response Rate (ORR)** in heavily pretreated patients receiving adequate lymphodepletion, including sCRs and MRD-negative patients[5](index=5&type=chunk) - **100% ORR** in patients not previously treated with a BCMA-targeted bispecific T-cell engaging antibody[5](index=5&type=chunk) - Favorable emerging safety and reliability profile, with low incidences of CRS and neurotoxicity observed (all ≤ Grade 2)[5](index=5&type=chunk) [P-MUC1C-ALLO1 (Solid Tumors)](index=2&type=section&id=P-MUC1C-ALLO1%20(Solid%20Tumors)) Enrollment continued for P-MUC1C-ALLO1 in solid tumors, with exploration of higher lymphodepletion and cell doses based on allogeneic BCMA CAR-T program insights - Continued enrollment in Phase 1 clinical trial for solid tumors, exploring higher lymphodepletion, cell dose, and scheduling based on insights from allogeneic BCMA CAR-T program[5](index=5&type=chunk) - Assessing lymphodepleting conditioning regimens with cyclophosphamide doses exceeding **300 mg/m²** in the MUC1C program, following observations of significantly elevated P-BCMA-ALLO1 levels with higher doses[5](index=5&type=chunk) [Roche Partnership Programs](index=2&type=section&id=Roche%20Partnership%20Programs) Roche partnership programs advanced with an accelerated $30 million milestone payment, expanded P-BCMA-ALLO1 enrollment, and initiated P-CD19CD20-ALLO1 for B-cell malignancies - Expected acceleration of achieving milestones resulted in the receipt of a **$30 million payment** in the first quarter of 2024[5](index=5&type=chunk) - Expanded the protocol and continued to enroll patients in the Phase 1 study of **P-BCMA-ALLO1**, incorporating lymphodepletion learnings from ASH 2023[5](index=5&type=chunk) - Continued site activation activities and initiation of enrollment for **P-CD19CD20-ALLO1**, the company's first dual, allogeneic CAR-T for B-cell malignancies[5](index=5&type=chunk) [Gene Therapy Program Updates](index=2&type=section&id=Gene%20Therapy%20Program%20Updates) Preclinical data for **P-FVIII-101** supported its potential for Hemophilia A, demonstrating stable Factor VIII expression, re-dosing capabilities, and favorable tolerability with 52-week durability - Presented proof-of-principle data supporting **P-FVIII-101** as a potential treatment option for Hemophilia A at ASH[4](index=4&type=chunk) - Data demonstrated stable **Factor VIII (FVIII)** transgene expression through genomic integration using the company's non-viral approach[4](index=4&type=chunk) - Highlighted re-dosing, or titrating to efficacy, along with favorable tolerability data, including **52-week durability** data in an adult Hemophilia A mouse model[4](index=4&type=chunk) [Operational Updates & Upcoming Events](index=3&type=section&id=Operational%20Updates%20%26%20Upcoming%20Events) Poseida plans multiple data presentations and R&D Days in 2024, alongside strategic expansion into autoimmune disease and key leadership changes [Anticipated Program Milestones](index=3&type=section&id=Anticipated%20Program%20Milestones) Poseida anticipates multiple 2024 data presentations for its CAR-T programs, including P-BCMA-ALLO1 and P-MUC1C-ALLO1 at AACR, an interim P-CD19CD20-ALLO1 update, and advancing P-PSMA-ALLO1 into IND-enabling studies - **P-BCMA-ALLO1**: Data presentation planned at AACR on April 8, 2024, for patients refractory to initial BCMA targeting therapy, with an additional clinical update in H2 2024[10](index=10&type=chunk) - **P-MUC1C-ALLO1**: Initial clinical findings from Phase 1 trial to be reviewed at AACR on April 8, 2024, with a more comprehensive clinical update in H2 2024[10](index=10&type=chunk) - **P-CD19CD20-ALLO1**: Interim data update expected in H2 2024, following Phase 1 trial initiation in late 2023[10](index=10&type=chunk) - **P-PSMA-ALLO1**: Next allogeneic solid tumor program in prostate cancer expected to advance into IND-enabling studies in 2024[10](index=10&type=chunk) [R&D Days](index=3&type=section&id=R%26D%20Days) Poseida plans two R&D Days in 2024: a gene therapy focused event on April 17, highlighting non-viral gene technologies, and a cell therapy focused event in the second half - Gene therapy specific R&D Day planned for **April 17, 2024**, featuring presentations on proprietary non-viral gene insertion and editing technologies, portfolio review, and new preclinical data[9](index=9&type=chunk) - Cell therapy focused R&D Day planned for the **second half of 2024**[9](index=9&type=chunk) [Strategic Expansion into Autoimmune Disease](index=3&type=section&id=Strategic%20Expansion%20into%20Autoimmune%20Disease) Poseida is actively developing a strategy to apply its TSCM-rich CAR-T platform and proprietary technologies to autoimmune and inflammatory diseases, with updates to follow - The company believes its **TSCM-rich CAR-T platform** and associated proprietary technologies have strong potential to deliver new therapeutic approaches in autoimmune disease[7](index=7&type=chunk)[11](index=11&type=chunk) - The company is actively developing a strategy in inflammation and autoimmune disease and will provide an update at an appropriate time[7](index=7&type=chunk)[11](index=11&type=chunk) [Leadership Updates](index=4&type=section&id=Leadership%20Updates) Poseida announced key leadership changes, including Alexander Chapman as SVP, IR & Corporate Communications, Loren Wagner's promotion to COO, and Brent Warner's departure as President, Gene Therapy - **Alexander Chapman** joined Poseida on February 26, 2024, as Senior Vice President, Investor Relations & Corporate Communications[12](index=12&type=chunk) - **Loren Wagner** was promoted to Chief Operations Officer in February 2024[13](index=13&type=chunk) - **Brent Warner**, President, Gene Therapy, will depart Poseida effective April 1, 2024, to pursue an external career opportunity[14](index=14&type=chunk) [Financial Results for Fourth Quarter and Full Year 2023](index=4&type=section&id=Financial%20Results%20for%20Fourth%20Quarter%20and%20Full%20Year%202023) This section details Poseida's financial performance for Q4 and full year 2023, covering revenues, operating expenses, net loss, and cash position [Revenues](index=4&type=section&id=Revenues) Q4 2023 revenues significantly increased due to a Roche milestone, while full-year 2023 revenues decreased primarily due to initial Roche license revenue recognized in 2022 Revenue Performance | Metric | Q4 2023 (Millions) | Q4 2022 (Millions) | YoY Change | FY 2023 (Millions) | FY 2022 (Millions) | YoY Change | | :---------------- | :----------------- | :----------------- | :--------- | :----------------- | :----------------- | :--------- | | Collaboration Revenue | $25.0 | $10.1 | +147.5% | $64.7 | $130.5 | -50.5% | - Q4 2023 revenue increase primarily due to a milestone achieved under the Roche collaboration and increased activity, offset by a decrease related to Takeda due to its collaboration termination[15](index=15&type=chunk) - Full-year 2023 revenue decrease primarily due to initial license revenue recognized from the Roche collaboration in Q3 2022, partially offset by research services revenue from Roche and Takeda (including **$8.9 million** of previously deferred revenue from Takeda termination)[16](index=16&type=chunk) [Operating Expenses](index=4&type=section&id=Operating%20Expenses) R&D expenses increased in Q4 and FY2023 due to preclinical and allogeneic clinical programs, partially offset by autologous program wind-down, while G&A expenses slightly decreased due to lower insurance costs [Research and Development Expenses](index=4&type=section&id=Research%20and%20Development%20Expenses) R&D expenses increased in Q4 and FY2023, driven by preclinical programs, increased headcount, and allogeneic clinical programs, partially offset by autologous program wind-down Research and Development Expenses | Metric | Q4 2023 (Millions) | Q4 2022 (Millions) | YoY Change | FY 2023 (Millions) | FY 2022 (Millions) | YoY Change | | :----------------------- | :----------------- | :----------------- | :--------- | :----------------- | :----------------- | :--------- | | Research and Development | $42.0 | $33.9 | +23.9% | $156.8 | $152.9 | +2.6% | - Increase primarily due to increased preclinical stage programs, research collaboration activity, personnel expenses (increased headcount), and clinical stage allogeneic programs[17](index=17&type=chunk)[18](index=18&type=chunk) - Partially offset by a decrease in clinical stage autologous programs due to the wind-down of development activities[17](index=17&type=chunk)[18](index=18&type=chunk) [General and Administrative Expenses](index=5&type=section&id=General%20and%20Administrative%20Expenses) G&A expenses decreased in Q4 and FY2023 primarily due to lower insurance costs, with the full-year decrease partially offset by increased personnel costs General and Administrative Expenses | Metric | Q4 2023 (Millions) | Q4 2022 (Millions) | YoY Change | FY 2023 (Millions) | FY 2022 (Millions) | YoY Change | | :-------------------------- | :----------------- | :----------------- | :--------- | :----------------- | :----------------- | :--------- | | General and Administrative | $8.9 | $9.4 | -5.3% | $37.4 | $37.5 | -0.3% | - Decrease primarily due to lower insurance costs in both Q4 and full year 2023[19](index=19&type=chunk)[20](index=20&type=chunk) - Full-year decrease was partially offset by an increase in personnel costs due to accelerated stock-based compensation expense related to the retirement of the company's former Executive Chairman in Q1 2023[20](index=20&type=chunk) [Net Loss](index=5&type=section&id=Net%20Loss) Poseida reported a reduced net loss in Q4 2023 but a significantly increased net loss for the full year, primarily driven by changes in revenue and operating expenses Net Loss and EPS | Metric | Q4 2023 (Millions) | Q4 2022 (Millions) | YoY Change | FY 2023 (Millions) | FY 2022 (Millions) | YoY Change | | :------- | :----------------- | :----------------- | :--------- | :----------------- | :----------------- | :--------- | | Net Loss | $(25.3) | $(33.3) | +23.9% | $(123.4) | $(64.0) | -92.8% | | Net Loss Per Share, Basic and Diluted | $(0.27) | $(0.39) | +30.8% | $(1.37) | $(0.89) | -53.9% | Weighted-Average Shares Outstanding | Metric | Q4 2023 | Q4 2022 | YoY Change | FY 2023 | FY 2022 | YoY Change | | :------------------------------------------------ | :---------- | :---------- | :--------- | :---------- | :---------- | :--------- | | Weighted-average number of shares outstanding, basic and diluted | 95,623,219 | 85,953,375 | +11.2% | 90,185,096 | 71,953,703 | +25.3% | [Cash Position](index=5&type=section&id=Cash%20Position) As of December 31, 2023, Poseida held **$212.2 million** in cash, projecting this, with anticipated Roche payments, to fund operations into H2 2025, with potential for further extension Cash Position | Metric | December 31, 2023 (Millions) | December 31, 2022 (Millions) | | :-------------------------------------- | :--------------------------- | :--------------------------- | | Cash, cash equivalents and short-term investments | $212.2 | $282.5 | - The company expects its cash, cash equivalents, and short-term investments, along with remaining near-term milestones and other payments from Roche, to fund operations into the **second half of 2025**[22](index=22&type=chunk) - Potential additional payments under the amended Roche collaboration and license agreement or additional business development could further extend cash runway[22](index=22&type=chunk) [Company Information & Disclosures](index=5&type=section&id=Company%20Information%20%26%20Disclosures) This section provides an overview of Poseida Therapeutics, its forward-looking statements, and detailed selected financial data [About Poseida Therapeutics, Inc.](index=5&type=section&id=About%20Poseida%20Therapeutics%2C%20Inc.) Poseida Therapeutics is a clinical-stage biopharmaceutical company developing differentiated cell and gene therapies for cancer and rare diseases, leveraging proprietary genetic editing platforms and in-house GMP manufacturing - Poseida Therapeutics is a clinical-stage biopharmaceutical company advancing differentiated cell and gene therapies with the capacity to cure certain cancers and rare diseases[23](index=23&type=chunk) - The company's pipeline includes allogeneic CAR-T cell therapy product candidates for both solid and liquid tumors, as well as in vivo gene therapy product candidates[23](index=23&type=chunk) - Its approach is based on proprietary genetic editing platforms, including non-viral **piggyBac® DNA Delivery System**, **Cas-CLOVER™ Site-Specific Gene Editing System**, **Booster Molecule**, and nanoparticle/hybrid gene delivery technologies, along with in-house GMP cell therapy manufacturing[23](index=23&type=chunk) [Forward-Looking Statements](index=5&type=section&id=Forward-Looking%20Statements) This section contains standard cautionary language regarding forward-looking statements, emphasizing that actual results may differ materially due to inherent biopharmaceutical industry risks and uncertainties - Statements regarding matters that are not historical facts are 'forward-looking statements' subject to risks and uncertainties[24](index=24&type=chunk)[25](index=25&type=chunk) - Risks include reliance on third parties, uncertainties with development and regulatory approval, ability to retain key personnel, limited control over Roche's efforts, and other risks described in SEC filings[25](index=25&type=chunk) - The company undertakes no obligation to update such statements to reflect events or circumstances after the date they were made, except as required by law[25](index=25&type=chunk) [Selected Financial Data](index=7&type=section&id=Selected%20Financial%20Data) This section provides detailed financial tables for the three and twelve months ended December 31, 2023 and 2022, covering Statements of Operations and Selected Balance Sheet Data Statements of Operations (in thousands) | | Three Months Ended Dec 31, 2023 | Three Months Ended Dec 31, 2022 | Twelve Months Ended Dec 31, 2023 | Twelve Months Ended Dec 31, 2022 | | :-------------------------- | :------------------------------ | :------------------------------ | :------------------------------- | :------------------------------- | | Collaboration revenue | $24,995 | $10,051 | $64,703 | $130,492 | | Total revenue | $24,995 | $10,051 | $64,703 | $130,492 | | Research and development | $42,045 | $33,904 | $156,772 | $152,899 | | General and administrative | $8,859 | $9,368 | $37,435 | $37,539 | | Total operating expenses | $50,904 | $43,272 | $194,207 | $190,438 | | Loss from operations | $(25,909) | $(33,221) | $(129,504) | $(59,946) | | Interest expense | $(2,267) | $(1,975) | $(8,671) | $(6,370) | | Other income, net | $2,827 | $2,170 | $14,852 | $2,858 | | Net loss before income tax | $(25,349) | $(33,026) | $(123,323) | $(63,458) | | Income tax expense | — | $(292) | $(107) | $(544) | | Net loss | $(25,349) | $(33,318) | $(123,430) | $(64,002) | | Net loss per share, basic and diluted | $(0.27) | $(0.39) | $(1.37) | $(0.89) | | Weighted-average number of shares outstanding, basic and diluted | 95,623,219 | 85,953,375 | 90,185,096 | 71,953,703 | Selected Balance Sheet Data (in thousands) | | December 31, 2023 | December 31, 2022 | | :-------------------------------------- | :------------------ | :------------------ | | Cash, cash equivalents and short-term investments | $212,202 | $282,493 | | Total assets | $273,885 | $351,837 | | Total liabilities | $170,184 | $164,242 | | Total stockholders' equity | $103,701 | $187,595 |
Poseida Therapeutics(PSTX) - 2023 Q3 - Quarterly Report
2023-11-09 21:11
Financial Performance - Collaboration revenue decreased to $9.4 million for Q3 2023 from $116.3 million in Q3 2022, a decline of $106.9 million [152]. - Collaboration revenue decreased to $39.7 million for the nine months ended September 30, 2023, down from $120.4 million in the same period in 2022, a decline of $80.7 million [160]. - Total operating expenses for the nine months ended September 30, 2023, were $143.3 million, a decrease of $3.9 million compared to $147.2 million in 2022 [159]. - The net loss for the nine months ended September 30, 2023, was $98.1 million, compared to a net loss of $30.7 million for the same period in 2022, an increase of $67.4 million [159]. - Other income, net increased to $12.0 million for the nine months ended September 30, 2023, from $0.7 million in 2022, an increase of $11.3 million [166]. - The company expects to continue incurring net losses and negative cash flows from operations for at least the next several years [167]. - During the nine months ended September 30, 2023, the company reported a net loss of $98.1 million, which was a significant increase from the net loss of $30.7 million in the same period of 2022 [181][182]. Research and Development - The company has not generated any revenue from product sales and is currently in the clinical stage of developing cell and gene therapies for cancer and rare diseases [121]. - P-MUC1C-ALLO1, a fully allogeneic CAR-T product candidate, is currently in a Phase 1 clinical trial, with an initial data update expected in the first half of 2024 [125]. - P-BCMA-ALLO1, targeting relapsed/refractory multiple myeloma, is also in a Phase 1 clinical trial, with Roche covering a majority of future development costs [127]. - The company is developing P-OTC-101 and P-FVIII-101, both liver-directed gene therapies, with P-OTC-101 receiving orphan drug designation from the FDA in July 2023 [128]. - The company expects to dose the first patient with P-CD19CD20-ALLO1 in early 2024, which is a dual CAR-T program targeting B-cell hematological indications [127]. - The company plans to share preclinical data on P-FVIII-101 at the ASH Annual Meeting in December 2023 [128]. - Research and development expenses increased to $37.5 million in Q3 2023 from $35.1 million in Q3 2022, an increase of $2.3 million [155]. - Research and development expenses for clinical stage programs totaled $6.0 million in Q3 2023, down from $8.7 million in Q3 2022, a decrease of $2.7 million [155]. - Personnel-related expenses within research and development increased by $3.4 million due to headcount growth [155]. - Research and development expenses were $114.7 million for the nine months ended September 30, 2023, down from $119.0 million in 2022, a reduction of $4.3 million [163]. Collaboration and Agreements - The Roche Collaboration Agreement includes an upfront payment of $110 million and potential total payments up to $6 billion based on development milestones and product sales [133]. - The collaboration with Roche includes program reimbursements to offset development costs, which are expected to rise due to increased research and development activities [127]. - The company plans to seek new strategic collaborations in gene therapy following the termination of the Takeda Collaboration Agreement [139]. - The company has no current commitments or agreements for new strategic collaborations despite the potential for future partnerships [139]. - The company recognized $8.9 million of previously deferred revenue during the nine months ended September 30, 2023, following the termination of the Takeda Collaboration Agreement [139]. - The company experienced a $22.5 million increase in deferred revenue related to the Astellas strategic rights agreement during the nine months ended September 30, 2023 [181]. Expenses and Cash Flow - General and administrative expenses decreased to $8.1 million in Q3 2023 from $9.4 million in Q3 2022, a decrease of $1.3 million [156]. - Interest expense rose to $2.2 million in Q3 2023 from $1.8 million in Q3 2022, an increase of $0.4 million due to higher interest rates [157]. - Interest expense increased to $6.4 million for the nine months ended September 30, 2023, compared to $4.4 million in 2022, an increase of $2.0 million due to higher interest rates [165]. - For the nine months ended September 30, 2023, net cash used in operating activities was $63.4 million, compared to $29.2 million for the same period in 2022, reflecting a significant increase in cash outflow [181][182]. - Cash used in investing activities for the nine months ended September 30, 2023, was $8.6 million, a decrease from $117.4 million in the same period of 2022, indicating a reduction in investment expenditures [183][184]. - Net cash provided by financing activities was $16.1 million for the nine months ended September 30, 2023, compared to $105.1 million in the same period of 2022, showing a decline in financing inflows [186][187]. - As of September 30, 2023, the company had cash, cash equivalents, and short-term investments totaling $238.8 million, providing a solid liquidity position [199]. - Cash, cash equivalents, and short-term investments as of September 30, 2023, totaled $238.8 million, expected to fund operations for at least the next twelve months [172]. - The company had $60.0 million of borrowings outstanding under the 2022 Loan Agreement, with a variable interest rate starting at 7.94% [200]. Other Financial Information - The company derecognized the liability associated with the P-PSMA-101 program and recorded it as other income during the nine months ended September 30, 2023 [142]. - Non-cash charges for the nine months ended September 30, 2023, included $18.1 million in stock-based compensation and $4.2 million in depreciation and amortization expenses [181]. - The company has not had any significant changes to its contractual obligations and commitments during the nine months ended September 30, 2023 [190]. - Foreign currency transaction gains and losses have not been material to the company's consolidated financial statements, and expenses are primarily denominated in U.S. dollars [201].