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Poseida Therapeutics Provides Updates and Financial Results for the Second Quarter of 2024

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Poseida Therapeutics (NASDAQ: PSTX) reported Q2 2024 financial results and updates on its cell therapy and genetic medicine programs. Key highlights include:

- Continued progress in Roche CAR-T partnership with $45 million in milestones in H1 2024
- Astellas collaboration momentum with nomination of first allogeneic solid tumor CAR-T program target
- On track for clinical updates across allogeneic CAR-T pipeline in H2 2024
- FDA granted INTERACT meeting for P-FVIII-101 genetic medicine program
- Q2 revenues of $26.0 million, up from $20.0 million in Q2 2023
- Net loss of $31.4 million for Q2 2024
- Cash position of $237.8 million as of June 30, 2024

The company expects its current cash position and near-term milestones to fund operations into H2 2025.

Poseida Therapeutics (NASDAQ: PSTX) ha riportato i risultati finanziari del Q2 2024 e aggiornamenti sui suoi programmi di terapia cellulare e medicina genetica. I punti salienti includono:

- Continuo progresso nella partnership con Roche CAR-T con $45 milioni in traguardi nella prima metà del 2024
- Slancio nella collaborazione con Astellas con la nomina del primo obiettivo per il programma CAR-T allogenico per tumori solidi
- Sulla buona strada per aggiornamenti clinici su tutto il pipeline CAR-T allogenico nella seconda metà del 2024
- L'FDA ha concesso una riunione INTERACT per il programma di medicina genetica P-FVIII-101
- Entrate del Q2 pari a $26,0 milioni, in aumento rispetto ai $20,0 milioni del Q2 2023
- Perdita netta di $31,4 milioni per il Q2 2024
- Posizione di cassa di $237,8 milioni al 30 giugno 2024

La società si aspetta che la sua attuale posizione di cassa e i traguardi a breve termine finanziino le operazioni fino alla seconda metà del 2025.

Poseida Therapeutics (NASDAQ: PSTX) informó los resultados financieros del Q2 2024 y actualizaciones sobre sus programas de terapia celular y medicina genética. Los aspectos más destacados incluyen:

- Progreso continuo en la colaboración con Roche CAR-T con $45 millones en hitos en la primera mitad de 2024
- Impulso en la colaboración con Astellas con la nominación del primer objetivo para el programa CAR-T alogénico de tumores sólidos
- En camino para actualizaciones clínicas en todo el pipeline de CAR-T alogénico en la segunda mitad de 2024
- La FDA concedió una reunión INTERACT para el programa de medicina genética P-FVIII-101
- Ingresos del Q2 de $26,0 millones, un aumento respecto a los $20,0 millones del Q2 2023
- Pérdida neta de $31,4 millones para el Q2 2024
- Posición de efectivo de $237,8 millones al 30 de junio de 2024

La empresa espera que su actual posición de efectivo y los hitos a corto plazo financien las operaciones hasta la segunda mitad de 2025.

Poseida Therapeutics (NASDAQ: PSTX)는 2024년 2분기 재무 결과와 세포 치료 및 유전자 의약 프로그램에 대한 업데이트를 발표했습니다. 주요 사항은 다음과 같습니다:

- 2024년 상반기 동안 Roche CAR-T 파트너십에서 $4500만 달러의 마일스톤을 달성하며 지속적인 진전을 이루었습니다.
- Astellas 협업에서 첫 번째 동종 이식 고형 종양 CAR-T 프로그램 목표를 지명하며 발전하였습니다.
- 2024년 하반기 전반에 걸쳐 동종 이식 CAR-T 파이프라인에 대한 임상 업데이트를 받을 예정입니다.
- FDA는 P-FVIII-101 유전자 의약 프로그램의 INTERACT 미팅을 승인하였습니다.
- 2024년 2분기 수익이 $2600만 달러로, 2023년 2분기의 $2000만 달러에서 증가했습니다.
- 2024년 2분기 순손실은 $3140만 달러입니다.
- 2024년 6월 30일 기준 현금 보유액이 $2억 3780만 달러입니다.

회사는 현재의 현금 보유액과 단기 마일스톤이 2025년 하반기까지 운영 자금을 지원할 것으로 예상하고 있습니다.

Poseida Therapeutics (NASDAQ: PSTX) a publié les résultats financiers du T2 2024 et des mises à jour sur ses programmes de thérapie cellulaire et de médecine génétique. Les points clés incluent :

- Progrès continu dans le partenariat CAR-T avec Roche avec 45 millions de dollars en jalons au premier semestre 2024
- Dynamisme dans la collaboration avec Astellas avec la nomination de la première cible pour le programme CAR-T allogénique pour tumeurs solides
- En bonne voie pour des mises à jour cliniques sur tout le pipeline CAR-T allogénique au cours du second semestre 2024
- L'FDA a accordé une réunion INTERACT pour le programme de médecine génétique P-FVIII-101
- Revenus du T2 s'élevant à 26,0 millions de dollars, en hausse par rapport à 20,0 millions de dollars au T2 2023
- Perte nette de 31,4 millions de dollars pour le T2 2024
- Position de trésorerie de 237,8 millions de dollars au 30 juin 2024

La société s'attend à ce que sa position de trésorerie actuelle et ses jalons à court terme financent ses opérations jusqu'au second semestre 2025.

Poseida Therapeutics (NASDAQ: PSTX) hat die Finanzzahlen für das 2. Quartal 2024 sowie Updates zu seinen Zelltherapie- und Gentherapieprogrammen veröffentlicht. Wesentliche Höhepunkte sind:

- Fortlaufender Fortschritt in der Roche CAR-T-Partnerschaft mit 45 Millionen US-Dollar an Meilensteinen in der ersten Hälfte des Jahres 2024
- Momentum bei der Zusammenarbeit mit Astellas durch die Nominierung des ersten Ziels für das allogene CAR-T-Programm bei soliden Tumoren
- Auf Kurs für klinische Updates im allogenen CAR-T-Pipeline in der zweiten Hälfte des Jahres 2024
- FDA genehmigte ein INTERACT-Meeting für das genetische Medizinprogramm P-FVIII-101
- Einnahmen im 2. Quartal in Höhe von 26,0 Millionen US-Dollar, ein Anstieg von 20,0 Millionen US-Dollar im 2. Quartal 2023
- Nettoprofit von 31,4 Millionen US-Dollar für das 2. Quartal 2024
- Liquiditätsposition von 237,8 Millionen US-Dollar am 30. Juni 2024

Das Unternehmen erwartet, dass seine derzeitige Liquiditätsposition und die kurzfristigen Meilensteine die Operationen bis in die zweite Hälfte des Jahres 2025 finanzieren werden.

Positive
  • Secured $45 million in milestone payments from Roche partnership in H1 2024
  • Received $50 million upfront payment from Astellas collaboration in Q2 2024
  • Q2 revenues increased 30% year-over-year to $26.0 million
  • Cash position of $237.8 million expected to fund operations into H2 2025
  • FDA granted INTERACT meeting for P-FVIII-101 genetic medicine program
Negative
  • Net loss increased to $31.4 million in Q2 2024 from $27.5 million in Q2 2023
  • Research and development expenses rose to $45.5 million in Q2 2024 from $39.2 million in Q2 2023
  • General and administrative expenses increased to $12.2 million in Q2 2024 from $8.7 million in Q2 2023

Insights

Poseida's Q2 2024 results show mixed financial performance. Revenue increased to $26 million, up 30% year-over-year, driven by milestone payments and increased R&D reimbursements from partnerships. However, net loss widened to $31.4 million from $27.5 million in Q2 2023, primarily due to higher R&D and G&A expenses.

The company's cash position of $237.8 million is bolstered by $95 million in milestone and upfront payments received in H1 2024. This runway, expected to last into H2 2025, provides a solid financial foundation for upcoming clinical trials and potential catalysts. The partnerships with Roche and Astellas are proving valuable, contributing significant non-dilutive funding.

Poseida's pipeline progress is encouraging, particularly in allogeneic CAR-T therapy. The advancement of the Roche partnership, including the $45 million milestone achievement and planned Phase 1b initiation for P-BCMA-ALLO1, signals strong collaborative momentum. The Astellas collaboration's first target nomination further validates Poseida's platform.

Upcoming clinical data readouts for P-BCMA-ALLO1, P-MUC1C-ALLO1 and P-CD19CD20-ALLO1 in H2 2024 are critical near-term catalysts. The company's expansion into autoimmune diseases could open new market opportunities. However, investors should closely monitor the outcomes of these trials, as they will be pivotal in determining the long-term viability of Poseida's allogeneic CAR-T platform.

Poseida's non-viral genetic medicines pipeline is showing promise, particularly with the FDA granting an INTERACT meeting for P-FVIII-101 in Hemophilia A. The preclinical data presented at ASGCT for both P-KLKB1-101 in HAE and P-FVIII-101 demonstrate encouraging efficacy and safety profiles. The Cas-CLOVER nuclease's high fidelity and efficiency in gene editing could provide a competitive advantage in the genetic medicine space.

The company's proprietary LNP technology and intracellular targeting agents offer potential for improved delivery and reduced immunogenicity. However, it's important to note that these programs are still in early stages and successful translation to human trials will be key. The upcoming data updates in Q4 2024 will be important in assessing the potential of these genetic medicine approaches.

Continued Roche CAR-T partnership progress with agreement for Poseida to initiate Phase 1b portion of P-BCMA-ALLO1 clinical trial 

Strong Astellas research collaboration momentum with nomination of first allogeneic solid tumor CAR-T program target

On track to deliver meaningful clinical updates across allogeneic CAR-T pipeline in the second half of 2024 with first data readout anticipated at International Myeloma Society annual meeting in September

Continued progress on non-viral genetic medicines pipeline, including FDA granting of INTERACT meeting for P-FVIII-101

SAN DIEGO, Aug. 5, 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 updates and financial results for the second quarter ended June 30, 2024.

"Poseida has delivered strong progress across our pipeline of innovative, non-viral allogeneic cell therapy and genetic medicine programs so far in 2024, setting the stage for significant potential catalysts in the second half of the year," said Kristin Yarema, Ph.D., President and Chief Executive Officer of Poseida Therapeutics. "For CAR-T, this is highlighted by multiple clinical data readouts across our BCMA, CD19CD20 and MUC1-C programs before year-end, the ongoing advancement of our partnerships with Roche and Astellas, and progress on our strategic approach to leveraging our allogeneic platform for autoimmune disease. We also expect new data from our genetic medicine programs that will continue to support the path towards IND filings and potential business development opportunities."

Recent Accomplishments

Cell Therapy

Advanced Roche partnership, securing $45 million from milestone execution in the first half of 2024, with additional milestones anticipated in the second half of the year, including a payment related to the planned initiation of the Phase 1b portion of the P-BCMA-ALLO1 clinical trial. Poseida and Roche have aligned on the Phase 1b trial design, which incorporates process improvements and feedback from recently completed advisory board meetings with leading clinicians and the study is expected to commence shortly. Poseida will continue to have operational responsibility for the expanded Phase 1/1b trial, which will be funded by Roche.

Progressed the strategic research collaboration and license agreement with Astellas' wholly owned subsidiary Xyphos Biosciences with the formal nomination of the first high-potential program target. Poseida received $50 million in an upfront payment during the second quarter of 2024 related to the initiation of the license agreement.

Genetic Medicine

Demonstrated ongoing leadership in development of non-viral approach to genetic medicines, supported by multiple data presentations at the American Society of Gene and Cell Therapy (ASGCT) 27th Annual Meeting featuring Poseida's lead genetic medicine approaches.

ASGCT data highlights:

  • In P-KLKB1-101 for hereditary angioedema (HAE), interim preclinical data in a non-human-primate (NHP) model showed that the Cas-CLOVER nuclease formulation was well tolerated and yielded dose-dependent levels of editing in early read-out data.
  • Studies in human cells and rodent models show high fidelity and high efficiency KLKB1 editing within a target range for correction of HAE. P-KLKB1-101 demonstrated a highly controlled dose-dependent reduction in kallikrein protein with human hepatocyte studies revealing minimal off-target editing. This was consistent with findings that Cas-CLOVER displays approximately 20-fold higher fidelity than Cas9, across multiple cell types and targets.
  • In P-FVIII-101 for Hemophilia A, preclinical rodent data support advancing to NHP studies based on sustained FVIII expression at physiologically desired levels over 13 months from a single dose, along with data supporting significantly reduced immunogenicity (relative to a conventional lipid nanoparticle (LNP)) and the ability to fine tune FVIII expression levels via repeat dosing and/or Poseida's proprietary modulator switch.
  • Additional data describing the Company's advancements in its proprietary LNP technology, intracellular targeting agents and nuclease fidelity.

In addition, the FDA recently granted an INTERACT meeting for P-FVIII-101 in September 2024, which will provide Poseida with early engagement and communication with FDA on the program, in order to support efficient development that is aligned with FDA standards. INTERACT meetings focus on innovative and emerging technologies covered by the FDA's Center for Biologics Evaluation and Research (CBER).

Upcoming Milestones

  • P-BCMA-ALLO1 in relapsed/refractory multiple myeloma (RRMM): new data anticipated for presentation at the International Myeloma Society 21st Annual Meeting, being held September 25-28, 2024, in Rio de Janeiro. Additional clinical updates are planned for the second half of 2024, subject to coordination with Roche.
  • P-MUC1C-ALLO1 in solid tumors: clinical update planned for the second half of 2024.
  • P-CD19CD20-ALLO1 in B-cell malignancies: interim data update anticipated in the second half of 2024, subject to coordination with Roche.
  • P-KLKB1-101 for HAE and P-FVIII-101 for Hemophilia A: data updates anticipated in the fourth quarter 2024.

Other Operational Updates and Upcoming Events

Manufacturing Updates
The Company continues to advance its platform process and analytical capabilities for allogeneic cell therapy manufacturing. Recent analytical enhancements have enabled more precise evaluation of prospective donors as well as providing superior characterization of drug product attributes.

Cell Therapy R&D Day
Poseida will host a cell therapy-focused R&D Day on November 14, 2024, to highlight progress and further opportunities across the Company, including its earlier stage allogeneic CAR-T pipeline. Further details on the event will be disclosed at a later time.

Evaluating Opportunities in CAR-T Beyond Oncology
The Company believes its TSCM-rich CAR-T platform and associated proprietary technologies have strong potential to deliver new therapeutic approaches in autoimmune disease. The Company remains well positioned to potentially advance an allogeneic CAR-T strategy for autoimmune disease and is actively working to identify the optimal opportunity to leverage its existing programs and/or platforms in areas where it is best positioned to lead. The Company will provide an update later this year.

Financial Results for the Second Quarter 2024

Revenues
Revenues were $26.0 million for the three months ended June 30, 2024, compared to $20.0 million for the same period in 2023. The increase was primarily due to milestone recognition and an increase in reimbursed research and development expenses under the Roche Collaboration Agreement.

Revenues were $54.1 million for the six months ended June 30, 2024 compared to $30.4 million for the same period in 2023. The increase was primarily due to milestone recognition and an increase in reimbursed research and development expenses under the Roche Collaboration Agreement, and revenue recognized from the Astellas Strategic Agreements.

Research and Development Expenses
Research and development expenses were $45.5 million for the three months ended June 30, 2024, and $88.5 million for the six months ended June 30, 2024 compared to $39.2 million and $77.2 million for the same periods in 2023, respectively. The increases were primarily due to an increase in allogeneic clinical stage programs, driven mainly by an increase in overall enrollment of the Company's allogeneic programs and the initiation of its third allogeneic clinical trial, P-CD19CD20-ALLO1, and by an increase in preclinical stage programs and other unallocated expenses.

General and Administrative Expenses
General and administrative expenses were $12.2 million for the three months ended June 30, 2024, compared to $8.7 million for the same period in 2023. The increase was primarily due to higher personnel expenses, mainly caused by an increase in stock-based compensation expense driven by a one-time expense associated with the succession plan in which the Company's former CEO became the Executive Chairman in 2024.

General and administrative expenses were $22.0 million for the six months ended June 30, 2024, compared to $20.5 million for the same period in 2023. The increase was primarily due to higher legal fees related to patent expenses and the Astellas Collaboration Agreement, and higher personnel expenses, mainly caused by an increase in stock-based compensation expense driven by a one-time expense associated with the succession plan in which the Company's former CEO became the Executive Chairman in 2024.

Net Loss
Net loss was $31.4 million and $55.6 million for the three and six months ended June 30, 2024, respectively, compared to net loss of $27.5 million and $66.3 million for the three and six months ended June 30, 2023, respectively.

Cash Position
As of June 30, 2024, the Company's cash, cash equivalents and short-term investments balance was $237.8 million. This includes $95 million in milestone and upfront payments generated in the first half of 2024, consisting of a $50 million upfront payment from the Astellas collaboration and $45 million from continued execution in the Company's CAR-T partnership with Roche. The Company expects that its cash, cash equivalents and short-term investments together with these and other remaining near-term milestones and other payments from Roche will be sufficient to fund operations into the second half of 2025 and potential additional anticipated progress and payments under the Roche Collaboration Agreement and/or potential additional business development could further extend the cash runway. 

About Poseida Therapeutics, Inc.
Poseida Therapeutics is a clinical-stage biopharmaceutical company advancing differentiated allogeneic cell therapies and genetic medicines with the capacity to cure certain cancers and rare diseases. The Company's pipeline includes investigational allogeneic CAR-T cell therapies for both solid tumors and hematologic cancers as well as investigational in vivo genetic medicines that address patient populations with high unmet medical need. The Company's approach is based on its proprietary genetic editing platforms, including its non-viral piggyBac® DNA Delivery System, Cas-CLOVER™ Site-Specific Gene Editing System, Booster Molecule and nanoparticle gene delivery technologies, as well as in-house GMP cell therapy manufacturing. The Company has formed strategic collaborations with Roche and Astellas to unlock the promise of cell therapies for cancer patients. Learn more at www.poseida.com and connect with Poseida on X 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, expected plans with respect to clinical trials, including timing of regulatory meetings and submissions and approvals and clinical data updates; potential fees, reimbursements, milestones, royalty payments and other payments that the Company may receive pursuant to its collaboration agreements with Roche and Astellas, including related timing; anticipated timelines and milestones with respect to the Company's development programs and manufacturing activities and capabilities; the potential capabilities and benefits of the Company's technology platforms and product candidates, including the efficacy, safety and tolerability profile of such product candidates or any ability to deliver therapeutic approaches in autoimmune disease; the quote from Dr. Yarema; estimates of the Company's cash balance, cash runway, expenses, capital requirements and any future revenue; the Company's ability to exploit and consummate additional business development opportunities, including with Roche and Astellas, and any anticipated impact on the Company's cash balance and cash runway; the Company's ability to attract and/or retain new and existing collaborators with relevant expertise and its expectations regarding the potential benefits to be derived from any such collaborations; and the Company'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 the Company'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 Company's reliance on third parties for various aspects of its business; risks associated with conducting clinical trials; whether any of the Company's product candidates will be shown to be safe and effective; the Company's ability to finance continued operations; the Company's reliance on third parties for various aspects of its business; competition in the Company's target markets; the Company's ability to protect its intellectual property; risks and uncertainties associated with development and regulatory approval of novel product candidates in the biopharmaceutical industry; the Company's ability to retain key scientific or management personnel; the fact that the Company will have limited control over the efforts and resources that its collaborators devote to advancing development programs under their respective collaboration agreements; the fact that the Company may not receive the potential fees, reimbursements and payments under the collaboration agreements; the ability of the Company's collaborators to early terminate the collaborations, such that the Company may not fully realize the benefits of the collaborations; and the other risks described in the Company'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. The Company 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

(In thousands, except share and per share amounts)




STATEMENTS OF OPERATIONS

(Unaudited)






Three Months Ended
June 30,



Six Months Ended
June 30,




2024



2023



2024



2023


Revenues:













Collaboration revenue


$

25,973



$

20,013



$

54,115



$

30,356


Total revenue



25,973




20,013




54,115




30,356


Operating expenses:













Research and development



45,547




39,192




88,468




77,244


General and administrative



12,182




8,676




21,980




20,483


Total operating expenses



57,729




47,868




110,448




97,727


Loss from operations



(31,756)




(27,855)




(56,333)




(67,371)


Other income (expense):













Interest expense



(2,259)




(2,141)




(4,512)




(4,169)


Other income, net



2,644




2,540




5,200




5,237


Net income (loss)


$

(31,371)



$

(27,456)



$

(55,645)



$

(66,303)















Net income (loss) per share, basic and diluted


$

(0.32)



$

(0.32)



$

(0.58)



$

(0.77)


Weighted-average number of shares outstanding, basic and diluted



96,965,025




86,794,697




96,492,301




86,531,422


 

SELECTED BALANCE SHEET DATA






June 30,
2024



December 31,
2023




(Unaudited)





Cash, cash equivalents and short-term investments



$       237,812




$      212,202


Total assets



298,686




273,885


Total liabilities



237,869




170,184


Total stockholders' equity



60,817




103,701


 

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SOURCE Poseida Therapeutics, Inc.

FAQ

What were Poseida Therapeutics' (PSTX) Q2 2024 revenue and net loss?

Poseida Therapeutics reported Q2 2024 revenues of $26.0 million and a net loss of $31.4 million.

How much cash does Poseida Therapeutics (PSTX) have as of June 30, 2024?

Poseida Therapeutics had a cash, cash equivalents, and short-term investments balance of $237.8 million as of June 30, 2024.

What milestone payments did Poseida Therapeutics (PSTX) receive in the first half of 2024?

Poseida Therapeutics received $45 million in milestone payments from its Roche partnership and a $50 million upfront payment from the Astellas collaboration in the first half of 2024.

When does Poseida Therapeutics (PSTX) expect to provide clinical updates on its allogeneic CAR-T pipeline?

Poseida Therapeutics is on track to deliver clinical updates across its allogeneic CAR-T pipeline in the second half of 2024, with the first data readout anticipated at the International Myeloma Society annual meeting in September.

Poseida Therapeutics, Inc.

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Biotechnology
Biological Products, (no Disgnostic Substances)
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United States of America
SAN DIEGO