UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☐ 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 (Mark One) Poseida Therapeutics, Inc. ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 (Exact Name of Registrant as Specified in its Charter) For the quarterly period ended September 30, 2021 Delaware 47-2846548 ...

Revenue Generation - The company has not generated any revenue from product sales and does not expect to do so until at least several years after obtaining regulatory approval for its product candidates [89][99]. Funding and Grants - The company has received a total of $19.7 million from a $19.8 million grant from the California Institute of Regenerative Medicine (CIRM) to support the clinical trial for P-BCMA-101 [102]. - The company expects to finance its operations through equity offerings, debt financings, or other capital sources until it can generate substantial product revenue [99]. Research and Development - The company is advancing multiple CAR-T product candidates in clinical phases, including P-BCMA-101 and P-PSMA-101, targeting relapsed/refractory multiple myeloma and metastatic castrate-resistant prostate cancer, respectively [93][94]. - The company anticipates significant increases in research and development expenses as it continues to develop its product candidates and seek regulatory approvals [98][108]. - The company is developing a fully allogeneic CAR-T product candidate, P-BCMA-ALLO1, with an IND filing and Phase 1 clinical trial initiation expected in Q3 2021 [94]. - The company is utilizing its proprietary piggyBac DNA Delivery System and Cas-CLOVER Site-specific Gene Editing System for manufacturing its product candidates [92][95]. - The company plans to file an IND and initiate a Phase 1 clinical trial for at least one dual CAR program in 2022 [96]. - The company is evaluating the potential modification of the P-OTC-101 program to utilize a fully non-viral nanoparticle delivery system, which could impact timelines [100]. Financial Performance - Research and development expenses increased to $36.0 million for the three months ended June 30, 2021, up from $25.2 million in the same period of 2020, representing a $10.8 million increase [114]. - General and administrative expenses rose to $8.9 million for the three months ended June 30, 2021, compared to $4.2 million in the same period of 2020, an increase of $4.6 million [117]. - The net loss for the three months ended June 30, 2021, was $45.7 million, compared to a net loss of $30.4 million for the same period in 2020, reflecting an increase of $15.3 million [114]. - For the six months ended June 30, 2021, research and development expenses totaled $65.1 million, up from $48.6 million in the same period of 2020, marking a $16.5 million increase [123]. - General and administrative expenses for the six months ended June 30, 2021, were $17.2 million, compared to $9.1 million for the same period in 2020, an increase of $8.2 million [124]. - The company incurred a net loss of $84.0 million for the six months ended June 30, 2021, compared to a net loss of $59.2 million for the same period in 2020, an increase of $24.8 million [120]. - As of June 30, 2021, the company had an accumulated deficit of $365.9 million [127]. Cash and Liquidity - Cash, cash equivalents, and short-term investments as of June 30, 2021, were $237.3 million, expected to fund operations for at least the next twelve months [129]. - As of June 30, 2021, the company had cash, cash equivalents, and short-term investments totaling $237.3 million, indicating a strong liquidity position [151]. - For the six months ended June 30, 2021, net cash used in operating activities was $70.1 million, compared to $53.7 million in the same period of 2020, reflecting an increase in cash outflow of approximately 30.5% [135][136]. - Cash provided by investing activities significantly increased to $185.4 million in the first half of 2021, up from $5.7 million in 2020, primarily due to proceeds from maturities of short-term investments [137][138]. - Cash provided by financing activities decreased to $0.4 million in the first half of 2021 from $107.4 million in 2020, which included substantial proceeds from the sale of Series D preferred stock in the prior year [140]. Interest and Expenses - Interest expense for the three months ended June 30, 2021, was $0.8 million, a slight decrease from $0.9 million in the same period of 2020 [118]. - Interest expense for the six months ended June 30, 2021, was $1.7 million, compared to $1.8 million for the same period in 2020 [125]. - Non-cash expenses for the first half of 2021 included $8.2 million in stock-based compensation and $2.2 million in depreciation and amortization [135]. Obligations and Regulations - The company has contractual obligations related to research and development, clinical trials, and license agreements, with payment obligations contingent on future milestones [141][142]. - The company is classified as an emerging growth company under the JOBS Act, allowing it to take advantage of certain reporting exemptions [146]. Inflation Impact - Inflation has not had a material effect on the company's consolidated financial statements, although it generally increases labor costs [154].

The Next Wave of Cell and Gene Therapies with the Capacity to Cure Corporate Overview Presentation May 2021 Disclaimer This presentation and any accompanying oral commentary contain "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts and include, without limitation, statements related to future events; our future financial performance or condition; business strategy; expec ...

Revenue Generation - The company has not generated any revenue from product sales and does not expect to do so until at least several years after obtaining regulatory approval for its product candidates[97][105]. - The company expects to finance its operations through equity offerings, debt financings, or other capital sources until it can generate substantial product revenue[105]. Product Development - The company is developing multiple CAR-T product candidates, including P-BCMA-101 and P-PSMA-101, with significant clinical trial progress reported, such as a >50% decline in PSA for one patient treated with P-PSMA-101[100]. - The company is working on a portfolio of allogeneic dual CAR product candidates, which are currently in preclinical studies, with plans to file an IND for at least one dual CAR program in 2022[102]. - The company has a significant focus on developing gene therapy product candidates that combine piggyBac technology with AAV to overcome limitations of traditional AAV gene therapy[103]. - The company is utilizing its proprietary gene engineering technologies, including the non-viral piggyBac DNA Delivery System and Cas-CLOVER Site-specific Gene Editing System, to develop its product candidates[98][101]. - The company plans to file an IND and initiate a Phase 1 clinical trial for P-BCMA-ALLO1 and P-MUC1C-ALLO1 by the end of 2021[105]. Financial Performance - Research and development expenses increased to $29.1 million for the three months ended March 31, 2021, up from $23.4 million in the same period of 2020, representing a 24.3% increase[121]. - General and administrative expenses rose to $8.4 million for the three months ended March 31, 2021, compared to $4.9 million in the same period of 2020, reflecting a 71.4% increase[123]. - The net loss for the three months ended March 31, 2021, was $38.3 million, compared to a net loss of $28.8 million for the same period in 2020, indicating a 33.5% increase in losses[120]. - Cash used in operating activities was $39.1 million for the three months ended March 31, 2021, compared to $22.9 million for the same period in 2020, representing an increase of 70.8%[134]. - Cash provided by investing activities was $124.5 million for the three months ended March 31, 2021, primarily from maturities of short-term investments[136]. - As of March 31, 2021, the company had an accumulated deficit of $320.2 million[126]. - The company expects to continue incurring net losses and negative cash flows from operations for at least the next several years[126]. - The company raised $224.0 million from the sale of common stock in its initial public offering in July 2020[128]. - The interest expense for the three months ended March 31, 2021, was $0.8 million, slightly down from $0.9 million in the same period of 2020[124]. - The company had cash, cash equivalents, and short-term investments of $270.0 million as of March 31, 2021, expected to fund operations for at least the next twelve months[128]. - As of March 31, 2021, the company had cash, cash equivalents, and short-term investments totaling $270.0 million[150]. - The company had $30.0 million of borrowings outstanding under the 2020 Amended Loan Agreement, with a variable interest rate of 30-day LIBOR plus 6.94%[152]. Accounting and Financial Policies - The company has not engaged in any off-balance sheet arrangements since inception[145]. - The company is classified as an emerging growth company and will remain so until it exceeds $1.07 billion in annual revenue or meets other specified criteria[146][147]. - There were no significant changes to the company's critical accounting policies and estimates during the three months ended March 31, 2021[144]. - The company has not had material foreign currency transaction gains or losses, and its expenses are generally denominated in U.S. dollars[153]. - A hypothetical 10% change in interest rates would not have had a material impact on the company's consolidated financial statements[151]. - Inflation has not had a material effect on the company's consolidated financial statements[154]. - The company has entered into several license agreements with milestone and royalty payment obligations contingent upon future events[141]. - The company has not included future payments under certain agreements in its financial statements due to the contingent nature of these obligations[141].

CAR-T Product Development - The company is advancing a broad pipeline with plans to have up to six CAR-T product candidates in the clinic by 2022, targeting both hematological and solid tumor oncology indications[14]. - The most advanced product candidate, P-BCMA-101, is in a potentially registrational Phase 2 clinical trial for relapsed/refractory multiple myeloma, with outpatient dosing approved by the FDA[14][23]. - P-BCMA-101, an autologous CAR-T targeting BCMA, is currently in a potentially registrational Phase 2 clinical trial, with interim results showing favorable tolerability and low levels of CRS[35]. - P-PSMA-101, an autologous CAR-T for mCRPC, demonstrated complete tumor cell elimination in 100% of preclinical models, with plans to accelerate its allogeneic version, P-PSMA-ALLO1, if clinical efficacy is promising[35]. - The company is developing both autologous and allogeneic CAR-T therapies targeting hematological malignancies, with a focus on commercializing in community hospital settings and outpatient infusion sites[46]. - The company is advancing its first CAR-T targeting MUC1-C, P-MUC1C-ALLO1, with an IND filing and Phase 1 clinical trial expected by the end of 2021[47]. - P-PSMA-101 achieved complete elimination of tumor cells to undetectable levels in 100% of animals in a preclinical model of mCRPC[109]. - P-BCMA-ALLO1, a fully allogeneic CAR-T product candidate, is anticipated to enter Phase 1 clinical trials by the first half of 2021[151]. - P-PSMA-ALLO1 is an allogeneic CAR-T product candidate targeting PSMA for mCRPC, with an IND filing and Phase 1 trial anticipated after analyzing preliminary results from P-PSMA-101[191]. Gene Delivery Technologies - The proprietary non-viral piggyBac DNA Delivery System allows for stable gene insertion with a significantly larger genetic cargo capacity compared to viral methods, potentially greater than 20 times that of lentivirus[26]. - The proprietary PiggyBac DNA Delivery System allows for cargo delivery greater than 200 kb, enabling the incorporation of multiple therapeutic genes[58]. - The proprietary non-viral piggyBac DNA Delivery System enables the generation of CAR-T products with a high percentage of TSCM cells, potentially leading to more consistent and durable responses with lower toxicity[79]. - The manufacturing process using piggyBac is more efficient and cost-effective compared to viral-based methods, eliminating costly materials and reducing production timelines[92]. - The piggyBac DNA Delivery System allows the expression of up to four full-length CAR molecule genes, enhancing the potential for targeted therapy[114]. - The company aims to replace AAV technology with nanoparticle-based delivery for gene therapies, which is expected to improve tolerability and lower costs while addressing limitations of AAV[49]. - The company is exploring nanoparticle technologies to eliminate the need for AAV in gene therapies, potentially broadening application areas[72]. - The combination of piggyBac with AAV is expected to enable stable and high expression levels of therapeutic transgenes, even at low doses, mitigating toxicity risks associated with AAV[212]. Safety and Efficacy - The company is developing a proprietary safety switch that can rapidly eliminate genetically modified cells post-administration, enhancing patient safety[28]. - The use of a cellular safety switch in product candidates aims to manage adverse events by controlling CAR-T cell numbers during treatment[91]. - The Cas-CLOVER gene editing technology shows low to no off-target activity, providing a tolerability advantage over other gene editing systems[26]. - The Cas-CLOVER gene editing technology enables precise site-specific editing with minimal off-target activity, preserving TSCM characteristics in CAR-T cells[61]. - Clinical data indicates a strong correlation between the percentage of TSCM cells in CAR-T products and clinical response, with TSCM cells potentially enhancing persistence and efficacy[81]. - The company focuses on selecting targets for CAR-T therapies that are less likely to undergo antigen escape, enhancing the likelihood of sustained efficacy[103]. - The piggyBac technology reduces the risk of oncogenesis compared to viral methods, as it shows low integration into intragenic regions and does not contain harmful LTR sequences[90]. Manufacturing and Cost Efficiency - The engineering of proprietary booster molecules enables the generation of hundreds of doses from a single manufacturing run, significantly reducing costs to levels comparable to traditional biologic therapeutics[22]. - The use of booster molecules allows the company to produce hundreds of doses from a single healthy donor, significantly driving down manufacturing costs[77]. - The company aims to reduce CAR-T manufacturing costs to levels comparable to traditional biologic therapeutics, enabling off-the-shelf availability[77]. - The manufacturing process for P-BCMA-ALLO1 aims for a product that is essentially 100% CAR-positive, with significant advantages in cost and commercial reach[155]. - The use of proprietary booster molecules resulted in approximately five times greater expansion of allogeneic CAR-T cells during manufacturing compared to runs without the booster[176]. - The piggyBac manufacturing system uses only GMP DNA and RNA, eliminating the need for GMP virus, which significantly reduces production costs[124]. Clinical Trials and Regulatory Designations - The company anticipates an IND filing and initiation of a Phase 1 clinical trial for P-OTC-101, a liver-directed gene therapy for OTC deficiency, in 2022, following significant preclinical success[42]. - The Phase 2 clinical trial is expected to enroll 120 patients, aiming to demonstrate significant response rates to support a biologics license application (BLA) submission[139]. - P-BCMA-101 was granted FDA Regenerative Medicine Advanced Therapy Designation in November 2018 and Orphan Drug Designation in May 2019[150]. - The Phase 1 clinical trial for P-BCMA-ALLO1 is anticipated to enroll up to 40 patients and is expected to begin in the first half of 2021[179]. - The company plans to conduct additional Phase 2 and comparative Phase 3 clinical trials to support approval and label expansion into earlier lines of therapy[150]. Company Overview and Team - The management team consists of 206 employees, with 110 holding advanced degrees, including 54 with a Ph.D. and/or M.D. degree[52]. - The company has a deep pipeline of proprietary product candidates with composition of matter protection through at least 2037, focusing on CAR-T for oncology and liver-directed gene therapy programs for rare diseases[29].

Efficacy and safety of P-BCMA-101 CAR-T cells in patients with relapsed/refractory (r/r) multiple myeloma (MM) C. Costello6, A. D. Cohen5, K. K. Patel3, S. Abbas Ali4, J. G. Berdeja2, N. Shah7, S. Ganguly8, M. Kocoglu9, M. Abedi10, A. Deol11, E. M. Ostertag12, C. E. Martin12, M. Ghoddusi12, D. J. Shedlock12, J. McCaigue12, H. Namini12, K. McArthur12, S. Yalamanchili12, M. A. Spear12, T. K. Gregory1 1Colorado Blood Cancer Inst., Denver, CO; 2Tennessee Oncology, Nashville, TN; 3MD Anderson Cancer Ctr., Housto ...

Financial Performance - The net losses for the three and nine months ended September 30, 2020, were $34.4 million and $93.6 million, respectively, compared to $21.0 million and $62.9 million for the same periods in 2019, resulting in an accumulated deficit of $245.7 million[115]. - The company reported net losses of $34.4 million and $93.6 million for the three and nine months ended September 30, 2020, respectively, compared to $21.0 million and $62.9 million for the same periods in 2019[162]. - Cash used in operating activities was $83.0 million for the nine months ended September 30, 2020, compared to $48.0 million for the same period in 2019[171]. - Total operating expenses for the three months ended September 30, 2020, were $33.5 million, up from $20.8 million in 2019, reflecting a change of $12.7 million[146]. - Total operating expenses for the nine months ended September 30, 2020, were $91.2 million, compared to $62.3 million in 2019, an increase of $28.9 million[154]. Revenue and Funding - The company has not generated any revenue from product sales and does not expect to do so until it successfully completes development and obtains regulatory approval for its product candidates[117]. - The company has raised an aggregate of $334.3 million from the sale of redeemable convertible preferred stock and $224.0 million from its IPO, with cash, cash equivalents, and short-term investments totaling $341.5 million as of September 30, 2020[115]. - Net cash provided by financing activities was $313.9 million for the nine months ended September 30, 2020, compared to $164.4 million in the same period of 2019[176]. - The company raised $224.0 million from the sale of common stock in its IPO and $334.3 million from redeemable convertible preferred stock since inception[162]. Research and Development - The company expects significant increases in expenses and losses as it continues to develop product candidates P-BCMA-101 and P-PSMA-101 and seeks regulatory approvals[116]. - Research and development expenses increased to $27.0 million for the three months ended September 30, 2020, up from $15.7 million in the same period of 2019, representing an increase of $11.3 million[148]. - Research and development expenses for the nine months ended September 30, 2020, were $75.6 million, compared to $41.2 million in 2019, an increase of $34.4 million[156]. - The increase in research and development expenses for the nine months ended September 30, 2020, was primarily due to $12.5 million in personnel expenses and $10.4 million in external costs related to clinical stage programs[156]. Operating Expenses - General and administrative expenses rose to $6.5 million for the three months ended September 30, 2020, compared to $4.0 million in 2019, an increase of $2.5 million[149]. - General and administrative expenses increased to $15.6 million for the nine months ended September 30, 2020, up from $14.4 million in the same period of 2019, primarily due to a $4.1 million rise in personnel expenses[157]. - Interest expense for the three months ended September 30, 2020, was $0.8 million, a slight decrease from $0.9 million in the same period of 2019[151]. - Interest expense was $2.7 million for the nine months ended September 30, 2020, slightly up from $2.6 million in the same period of 2019[160]. Acquisitions and Agreements - The company completed the acquisition of Vindico for $1.1 million in cash and 350,522 shares of common stock, with additional consideration based on developmental milestones[129]. - The company has entered into multiple license agreements, including a $0.2 million upfront fee to Janssen for exclusive rights to develop CAR-modified T-cells[121]. - The company has paid approximately $3.3 million in milestone development fees related to P-BCMA-101 and $0.7 million for P-PSMA-101 as part of its license agreement with Janssen[122]. - The company received a grant of $19.8 million from CIRM to support the clinical trial for P-BCMA-101, with $19.7 million received as of September 30, 2020[131]. Cash and Investments - Cash and cash equivalents as of September 30, 2020, were $341.5 million, expected to fund operations for at least the next twelve months[162]. - Net cash used in investing activities was $252.4 million for the nine months ended September 30, 2020, compared to $52.8 million in the same period of 2019[173]. - As of September 30, 2020, the company had cash, cash equivalents, and short-term investments totaling $341.5 million[189]. Other Financial Information - The company has incurred significant operating losses and expects to continue incurring such losses for the foreseeable future due to ongoing research and development activities[116]. - The contingent consideration liability related to the Vindico acquisition was $0 for the three months ended September 30, 2020, compared to $1.1 million in 2019[150]. - The interest rate applicable to the company's Term Loans borrowing was 8.9% as of September 30, 2020[166]. - The company had $30.0 million of borrowings outstanding under the 2018 Loan Agreement, with a variable interest rate of 30-day LIBOR plus 6.94%[190]. - The company remains an emerging growth company until it exceeds $1.07 billion in annual revenue or meets other specified criteria[187]. - Foreign currency transaction gains and losses have not been material to the company's consolidated financial statements[191]. - Inflation has generally increased the company's labor costs, but it has not had a material effect on the financial statements[192]. - The company has not had a formal hedging program for foreign currency, and expenses are primarily in U.S. dollars[191]. - A hypothetical 10% change in interest rates would not have had a material impact on the company's consolidated financial statements[189]. - The company has elected to use an extended transition period under the JOBS Act for compliance with new accounting standards[186]. - There were no significant changes to critical accounting policies and estimates during the nine months ended September 30, 2020[183].

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2020 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 (Sta ...