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Precigen Reports Second Quarter and First Half 2024 Financial Results and Business Updates

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Precigen (PGEN) reported Q2 and H1 2024 financial results, highlighting key developments for its lead program PRGN-2012 in recurrent respiratory papillomatosis (RRP):

- Pivotal study data showed 51% of RRP patients achieved Complete Response
- Rolling BLA submission anticipated in H2 2024
- Confirmatory trial enrollment initiated
- Appointed new CCO to lead potential 2025 commercial launch
- Raised $31.4M via public offering

The company is prioritizing PRGN-2012 advancement and streamlining other programs. Q2 net loss was $58.8M vs $20.3M in Q2 2023, impacted by $32.9M impairment charge. R&D expenses increased 32% YoY to $15.7M. Cash expected to fund operations into early 2025.

Precigen (PGEN) ha riportato i risultati finanziari per il secondo trimestre e il primo semestre del 2024, mettendo in evidenza sviluppi chiave per il suo programma principale PRGN-2012 nella papillomatosi respiratoria ricorrente (RRP):

- I dati dello studio pivotale hanno mostrato che il 51% dei pazienti con RRP ha raggiunto una Risposta Completa
- Si prevede una presentazione progressiva della BLA nella seconda metà del 2024
- È stato avviato l'inserimento nello studio di conferma
- Nomina di un nuovo CCO per guidare il potenziale lancio commerciale nel 2025
- Raccolti 31,4 milioni di dollari tramite un'offerta pubblica

L'azienda sta dando priorità all'avanzamento di PRGN-2012 e semplificando altri programmi. La perdita netta nel secondo trimestre è stata di 58,8 milioni di dollari rispetto ai 20,3 milioni di dollari del secondo trimestre del 2023, influenzata da un onere per impairment di 32,9 milioni di dollari. Le spese per R&S sono aumentate del 32% su base annua, raggiungendo i 15,7 milioni di dollari. Si prevede che il cash consenta di finanziare le operazioni fino all'inizio del 2025.

Precigen (PGEN) informó los resultados financieros del segundo trimestre y la primera mitad de 2024, destacando desarrollos clave para su programa principal PRGN-2012 en la papillomatosis respiratoria recurrente (RRP):

- Los datos del estudio pivotal mostraron que el 51% de los pacientes con RRP lograron una Respuesta Completa
- Se anticipa la presentación continua de la BLA en la segunda mitad de 2024
- Se inició la inscripción en el ensayo de confirmación
- Se nombró un nuevo CCO para liderar el posible lanzamiento comercial en 2025
- Se recaudaron 31,4 millones de dólares a través de una oferta pública

La compañía está priorizando el avance de PRGN-2012 y simplificando otros programas. La pérdida neta del segundo trimestre fue de 58,8 millones de dólares frente a 20,3 millones en el segundo trimestre de 2023, afectada por un cargo por deterioro de 32,9 millones. Los gastos de I+D aumentaron un 32% interanual, alcanzando los 15,7 millones de dólares. Se espera que el efectivo financie las operaciones hasta principios de 2025.

프레시겐(Precigen, PGEN)은 2024년 2분기 및 상반기 재무 결과를 보고하며, 재발성 호흡기 유두종증(RRP)을 대상으로 하는 주요 프로그램 PRGN-2012의 주요 발전 사항을 강조했습니다:

- 주요 연구 데이터에 따르면 RRP 환자의 51%가 완전 반응을 얻었습니다.
- 2024년 하반기에 반복적 BLA 제출이 예상됩니다.
- 확인 시험 모집이 시작되었습니다.
- 2025년 상용 출시에 대비하여 새로운 CCO를 임명했습니다.
- 공개 제안을 통해 3,140만 달러를 모금했습니다.

회사는 PRGN-2012의 발전에 우선 순위를 두고 다른 프로그램을 간소화하고 있습니다. 2분기 순손실은 5,880만 달러로, 2023년 2분기에는 2,030만 달러에 비해 증가했으며, 3,290만 달러의 손상 차감이 영향을 미쳤습니다. 연구 및 개발 비용은 전년 대비 32% 증가하여 1,570만 달러에 달했습니다. 자금은 2025년 초까지 운영을 지원할 것으로 예상됩니다.

Precigen (PGEN) a rapporté les résultats financiers du deuxième trimestre et du premier semestre 2024, mettant en avant des développements clés pour son programme phare PRGN-2012 dans la papillomatose respiratoire récurrente (RRP) :

- Les données de l'étude pivot ont montré que 51 % des patients atteints de RRP ont obtenu une Réponse Complète
- Une soumission progressive de la BLA est prévue pour le deuxième semestre 2024
- L'inscription à l'essai de confirmation a débuté
- Un nouveau CCO a été nommé pour diriger le lancement commercial potentiel en 2025
- 31,4 millions de dollars ont été levés par le biais d'une offre publique

L'entreprise accorde la priorité à l'avancement de PRGN-2012 et rationalise les autres programmes. La perte nette du deuxième trimestre s'élevait à 58,8 millions de dollars contre 20,3 millions de dollars au deuxième trimestre 2023, affectée par une charge de dépréciation de 32,9 millions de dollars. Les dépenses en R&D ont augmenté de 32 % par rapport à l'année précédente, atteignant 15,7 millions de dollars. La trésorerie devrait financer les opérations jusqu'au début de 2025.

Precigen (PGEN) hat die finanziellen Ergebnisse für das zweite Quartal und das erste Halbjahr 2024 veröffentlicht und wichtige Entwicklungen für sein Hauptprogramm PRGN-2012 bei der wiederkehrenden respiratorischen Papillomatose (RRP) hervorgehoben:

- Pivotal Studienergebnisse zeigten, dass 51% der RRP-Patienten eine vollständige Antwort erreichten
- Eine schrittweise BLA-Einreichung wird für die zweite Hälfte von 2024 erwartet
- Die Rekrutierung für die Bestätigungsstudie wurde eingeleitet
- Neuer CCO wurde ernannt, um den potenziellen kommerziellen Launch 2025 zu leiten
- 31,4 Millionen Dollar wurden durch ein öffentliches Angebot gesammelt

Das Unternehmen priorisiert den Fortschritt von PRGN-2012 und strafft andere Programme. Der Nettoverlust im zweiten Quartal betrug 58,8 Millionen Dollar gegenüber 20,3 Millionen Dollar im zweiten Quartal 2023, beeinflusst durch eine Wertminderung in Höhe von 32,9 Millionen Dollar. Die F&E-Ausgaben stiegen im Jahresvergleich um 32% auf 15,7 Millionen Dollar. Die liquiden Mittel werden voraussichtlich die Operationen bis Anfang 2025 finanzieren.

Positive
  • 51% of RRP patients achieved Complete Response in PRGN-2012 pivotal study
  • Rolling BLA submission for PRGN-2012 anticipated in H2 2024
  • Initiated enrollment in PRGN-2012 confirmatory trial
  • Raised $31.4M via public offering to strengthen cash position
  • Appointed new Chief Commercial Officer to lead potential 2025 PRGN-2012 launch
Negative
  • Q2 net loss increased to $58.8M from $20.3M in Q2 2023
  • $32.9M impairment charge related to ActoBio subsidiary shutdown
  • R&D expenses increased 32% year-over-year to $15.7M
  • Total revenues decreased 59% year-over-year
  • Pausing or discontinuing several clinical and preclinical programs

Insights

Precigen's Q2 2024 results reveal a strategic shift towards PRGN-2012, their promising RRP treatment. The pivotal study's 51% complete response rate is impressive, potentially leading to FDA approval. However, this focus comes at a cost:

  • R&D expenses increased by $3.8 million (32%)
  • SG&A expenses rose by $1 million (11%)
  • Net loss widened to $58.8 million vs $20.3 million in Q2 2023

The $31.4 million raised will fund operations into early 2025, but the cash burn rate is concerning. Investors should monitor the BLA submission progress and potential partnerships for UltraCAR-T programs.

Precigen's PRGN-2012 data is truly groundbreaking for RRP treatment. The 51% complete response rate and 86% reduction in surgical interventions are remarkable outcomes for this rare disease. The therapy's safety profile and durable responses beyond 12 months are equally impressive.

However, the company's decision to pause other promising programs like PRGN-3005 and PRGN-3007 is a double-edged sword. While it allows focus on PRGN-2012's potential commercialization, it may limit future pipeline diversity. The success of PRGN-2012's BLA submission and potential 2025 launch will be important for Precigen's future.

Precigen's all-in strategy on PRGN-2012 is a calculated risk in the competitive biotech landscape. The RRP market, while niche, represents a significant unmet need. If approved, PRGN-2012 could become the first FDA-approved therapy for RRP, potentially securing a strong market position.

However, the company's 20% workforce reduction and suspension of ActoBio operations signal a major restructuring. This streamlining may improve efficiency but could limit the company's ability to pivot if PRGN-2012 faces setbacks. The success of strategic partnerships for UltraCAR-T programs will be important for maintaining a diverse portfolio and mitigating risk.

In June 2024, the Company announced groundbreaking pivotal study data for PRGN-2012 gene therapy at the 2024 ASCO annual meeting in which more than half of RRP patients achieved Complete Response –

In July 2024, the Company appointed Phil Tennant as Chief Commercial Officer to spearhead potential PRGN-2012 commercial launch –

In August 2024, the Company announced a strategic reprioritization of its pipeline to focus on advancement of its lead program, PRGN-2012 in RRP –

PRGN-2012 rolling BLA submission, under an accelerated approval pathway, is anticipated in the second half of 2024; the Company has initiated enrollment in the confirmatory clinical trial of PRGN-2012 –

In August 2024, the Company strengthened its cash position by raising approximately $31.4 million via a public offering of common stock 

GERMANTOWN, Md., Aug. 14, 2024 /PRNewswire/ -- Precigen, Inc. (Nasdaq: PGEN), a biopharmaceutical company specializing in the development of innovative gene and cell therapies to improve the lives of patients, today announced second quarter and first half 2024 financial results and business updates.

"We are all in on PRGN-2012 given the immense unmet need for RRP patients and our groundbreaking pivotal data supporting the potential of what we hope to be the first-ever FDA approved therapy to treat RRP," said Helen Sabzevari, PhD, President and CEO of Precigen. "By strategically focusing our portfolio, streamlining resources and recent public offering, we have optimized the company to rapidly prepare for submission of a rolling biologics license application under an accelerated approval pathway. We are excited to have initiated enrollment in the confirmatory clinical trial and will continue to accelerate our commercial readiness campaign for a potential launch in 2025 under the leadership of our newly hired Chief Commercial Officer. Additionally, we plan to maximize portfolio value by focusing on strategic partnerships to further advance our highly promising UltraCAR-T programs." 

"Our recent reprioritization and public offering is expected to fund our operations into early 2025 allowing us to focus on advancement of PRGN-2012 while continuing to explore potential non-dilutive financing opportunities for future liquidity," said Harry Thomasian Jr., CFO of Precigen.

Key Program Highlights

  • PRGN-2012 AdenoVerse® Gene Therapy in RRP: PRGN-2012 is an investigational off-the-shelf AdenoVerse gene therapy designed to elicit immune responses directed against cells infected with human papillomavirus (HPV) 6 or HPV 11 for the treatment of recurrent respiratory papillomatosis (RRP). PRGN-2012 received Breakthrough Therapy Designation from the US Food and Drug Administration (FDA). PRGN-2012 also received Orphan Drug Designation from the FDA and Orphan Drug Designation from the European Commission.
    • Results from the pivotal clinical study of PRGN-2012 for the treatment of RRP were presented at the 2024 American Society of Clinical Oncology (ASCO) annual meeting in a late-breaking oral presentation titled, "PRGN-2012, a novel gorilla adenovirus-based immunotherapy, provides the first treatment that leads to complete and durable responses in recurrent respiratory papillomatosis patients."
      • Pivotal study met primary safety and efficacy endpoints.
      • 51% (18 out of 35) of patients achieved Complete Response, requiring no surgeries after treatment with PRGN-2012; Complete Responses have been durable beyond 12 months with median duration of follow up of 20 months as of the May 20, 2024 data cutoff.
      • 86% of patients (30 out of 35) had a decrease in surgical interventions in the year after PRGN-2012 treatment compared to the year prior to treatment; RRP surgeries reduced from a median of 4 (range: 3-10) pre-treatment to 0 (range: 0-7) post-treatment.
      • PRGN-2012 was well-tolerated with no dose-limiting toxicities and no treatment-related adverse events greater than Grade 2.
      • PRGN-2012 treatment induced HPV 6/11-specific T cell responses in RRP patients with a significantly greater expansion of peripheral HPV-specific T cells in responders compared with non-responders.
      • PRGN-2012 significantly (p < 0.0001) improved Derkay and quality of life scores in complete responders.
    • A rolling Biologics License Application (BLA) submission under an accelerated approval pathway is anticipated in the second half of 2024.
    • The Company has initiated enrollment in the confirmatory clinical trial, in accordance with the guidance from the FDA, prior to submission of the BLA.
    • The Company and the Recurrent Respiratory Papillomatosis Foundation held the inaugural RRP Awareness Day on June 11, 2024. The multi-stakeholder event raised awareness by bringing together individuals living with RRP, caregivers, clinicians, and government officials.
  • Strategic Prioritization: In August 2024, the Company announced a strategic prioritization of its clinical portfolio and associated streamlining of resources, including a reduction of over 20% of its workforce, to focus on potential commercialization of PRGN-2012.
    • PRGN-2009 AdenoVerse® Gene Therapy Clinical Trials
      • The Company plans to continue PRGN-2009 Phase 2 clinical trials under a cooperative research and development agreement (CRADA) with the National Cancer Institute (NCI) in recurrent/metastatic cervical cancer and in newly diagnosed HPV-associated oropharyngeal cancer.
      • PRGN-2009 cervical cancer clinical trial enrollment at non-NCI clinical sites will be paused.
    • UltraCAR-T® Clinical Programs 
    • Preclinical Programs
      • The Company will pause all preclinical programs.
    • ActoBio
      • The Company has initiated shutdown of its Belgium-based ActoBio subsidiary operations, including planned elimination of all ActoBio personnel.
      • In conjunction with this shutdown, ActoBio's portfolio of intellectual property will be made available for prospective transactions.

Financial Highlights

  • Strategic prioritization resulted in non-cash impairment charges of $32.9 million, net of tax, in the second quarter and severance charges of $3.0 million, of which $2.1 million was recorded in the second quarter and $0.9 million is expected to be recorded in the third quarter.
  • The Company closed a public offering of its common stock in August 2024, resulting in net proceeds of approximately $31.4 million.

Second Quarter 2024 Financial Results Compared to Prior Year Period

Research and development expenses increased $3.8 million, or 32%, compared to the three months ended June 30, 2023.  Salaries, benefits, and other personnel costs increased $2.1 million primarily due to severance charges related to the shutdown of the Company's ActoBio subsidiary. Additionally, fees paid to contract research organizations related to the start of the PRGN-2012 confirmatory clinical trial and close out of the PRGN-2012 pivotal clinical trial activities and professional fees incurred related to our manufacturing facility readiness for anticipated BLA submission increased compared to the same period in 2023.

SG&A expenses increased by $1.0 million, or 11%, compared to the three months ended June 30, 2023. This increase was primarily driven by severance costs incurred related to the suspension of ActoBio operations of $0.4 million, increased costs associated with PRGN-2012 commercial readiness as well as increased professional fees incurred related to general corporate matters compared to the same period in 2023.

In conjunction with the suspension of ActoBio's operations, the Company recorded $34.5 million of impairment charges related to goodwill and other noncurrent assets in the second quarter of 2024, as well as a related tax benefit of $1.7 million.

Total revenues decreased $1.1 million, or 59%, compared to the three months ended June 30, 2023. This decrease was related to reductions in product and service revenues at Exemplar.

Net loss was $58.8 million, or $(0.23) per basic and diluted share, compared to net loss of $20.3 million, or $(0.08) per basic and diluted share, in period ended June 30, 2023.

First Half 2024 Financial Results Compared to Prior Year Period

Research and development expenses increased $5.9 million, or 25%, compared to the six months ended June 30, 2023.  Salaries, benefits, and other personnel costs increased by $3.3 million primarily due to $2.1 million of severance charges related to the shutdown of the Company's ActoBio subsidiary and an increase in the hiring of employees related to the advancement of PRGN-2012 in 2023 at Precigen. Additionally, fees paid to contract research organizations related to the start of the PRGN-2012 confirmatory clinical trial and close out of the PRGN-2012 pivotal clinical trial activities and professional fees incurred related to our manufacturing facility readiness for anticipated BLA submission increased compared to the prior year period. These increases were offset by lower costs incurred at contract research organizations for other programs compared to the same period in 2023.

SG&A expenses decreased by $0.5 million, or 2%, compared to the six months ended June 30, 2023. This decrease was primarily due to lower stock compensation and insurance expenses in 2024 compared to the same period in 2023. These decreases were offset by severance costs incurred in the second quarter of 2024 related to the suspension of ActoBio's operations, and increased costs related to PRGN-2012 commercial readiness compared to the same period in 2023.

In conjunction with the suspension of ActoBio's operations, the Company recorded $34.5 million of impairment charges related to goodwill and other noncurrent assets in the second quarter of 2024, as well as a related tax benefit of $1.7 million.

Total revenues decreased $1.9 million, or 51%, compared to the six months ended June 30, 2023. This decrease was related to reductions in product and service revenues at Exemplar.

Net loss was $82.5 million, or $(0.33) per basic and diluted share, compared to net loss of $43.1 million, or $(0.18) per basic and diluted share, in period ended June 30, 2023.

Precigen: Advancing Medicine with Precision
Precigen (Nasdaq: PGEN) is a dedicated discovery and clinical stage biopharmaceutical company advancing the next generation of gene and cell therapies using precision technology to target the most urgent and intractable diseases in our core therapeutic areas of immuno-oncology, autoimmune disorders, and infectious diseases. Our technologies enable us to find innovative solutions for affordable biotherapeutics in a controlled manner. Precigen operates as an innovation engine progressing a preclinical and clinical pipeline of well-differentiated therapies toward clinical proof-of-concept and commercialization. For more information about Precigen, visit www.precigen.com or follow us on X @Precigen, LinkedIn or YouTube.

Trademarks
Precigen, UltraCAR-T, UltraPorator, AdenoVerse, UltraVector and Advancing Medicine with Precision are trademarks of Precigen and/or its affiliates. Other names may be trademarks of their respective owners.

Cautionary Statement Regarding Forward-Looking Statements
Some of the statements made in this press release are forward-looking statements. These forward-looking statements are based upon the Company's current expectations and projections about future events and generally relate to plans, objectives, and expectations for the development of the Company's business, including the timing and progress of preclinical studies, clinical trials, discovery programs and related milestones, the promise of the Company's portfolio of therapies, and in particular its CAR-T and AdenoVerse therapies. Although management believes that the plans and objectives reflected in or suggested by these forward-looking statements are reasonable, all forward-looking statements involve risks and uncertainties and actual future results may be materially different from the plans, objectives and expectations expressed in this press release. The Company has no obligation to provide any updates to these forward-looking statements even if its expectations change. All forward-looking statements are expressly qualified in their entirety by this cautionary statement. For further information on potential risks and uncertainties, and other important factors, any of which could cause the Company's actual results to differ from those contained in the forward-looking statements, see the section entitled "Risk Factors" in the Company's most recent Annual Report on Form 10-K and subsequent reports filed with the Securities and Exchange Commission.

Investor Contact:
Steven M. Harasym
Vice President, Investor Relations 
Tel: +1 (301) 556-9850 
investors@precigen.com 

Media Contacts:
Donelle M. Gregory
press@precigen.com 

Glenn Silver
Lazar-FINN Partners
glenn.silver@finnpartners.com 

 

Precigen, Inc. and Subsidiaries

Consolidated Balance Sheets

(Unaudited)




(Amounts in thousands)

June 30, 2024

December 31, 2023

Assets



Current assets



    Cash and cash equivalents

$                              9,345

$                                       7,578

    Short-term investments

10,191

55,277

    Receivables



        Trade, net

511

902

        Other

505

673

    Prepaid expenses and other

3,163

4,325

                Total current assets

23,715

68,755

    Property, plant and equipment, net

13,451

7,111

    Intangible assets, net

5,091

40,701

    Goodwill

24,918

26,612

    Right-of-use assets

5,550

7,097

    Other assets

435

767

                Total assets

$                           73,160

$                                   151,043

Liabilities and Shareholders' Equity



Current liabilities



    Accounts payable

$                              4,846

$                                       1,726

    Accrued compensation and benefits

6,675

8,250

    Other accrued liabilities

6,642

6,223

    Settlement and Indemnification Accrual

3,213

5,075

    Deferred revenue

378

509

    Current portion of lease liabilities

1,269

1,202

                Total current liabilities

23,023

22,985

    Deferred revenue, net of current portion

1,818

1,818

    Lease liabilities, net of current portion

5,072

5,895

    Deferred tax liabilities

77

1,847

                Total liabilities

29,990

32,545

Shareholders' equity



    Common stock

-

-

    Additional paid-in capital

2,093,080

2,084,916

    Accumulated deficit

(2,047,001)

(1,964,471)

    Accumulated other comprehensive loss

(2,909)

(1,947)

                Total shareholders' equity

43,170

118,498

                Total liabilities and shareholders' equity

$                           73,160

$                                   151,043

 

Precigen, Inc. and Subsidiaries

Consolidated Statements of Operations

(Unaudited)





Three Months Ended

Six Months Ended

(Amounts in thousands, except share and per share data)

June 30, 2024

June 30, 2023

June 30, 2024

June 30, 2023

Revenues





Product revenues

$                31

$              324

$              169

$              648

Service revenues

673

1,438

1,592

2,965

Other revenues

13

5

21

5

Total revenues

717

1,767

1,782

3,618

Operating Expenses





Cost of products and services

1,014

1,697

2,089

3,224

Research and development

15,693

11,874

29,942

24,037

Selling, general and administrative

10,306

9,316

20,457

20,954

Impairment of goodwill

1,630

-

1,630

-

Impairment of other noncurrent assets

32,915

-

32,915

-

Total operating expenses

61,558

22,887

87,033

48,215

Operating loss

(60,841)

(21,120)

(85,251)

(44,597)

Other Income (Expense), Net





Interest expense

(2)

(136)

(4)

(460)

Interest income

319

828

927

1,460

Other income, net

43

44

80

424

Total other income, net

360

736

1,003

1,424

Loss before income taxes

(60,481)

(20,384)

(84,248)

(43,173)

Income tax benefit

1,689

65

1,718

120

Net loss

$         (58,792)

$         (20,319)

$        (82,530)

$         (43,053)

Net Loss per share





Net loss per share, basic and diluted

$            (0.23)

$            (0.08)

$            (0.33)

$            (0.18)

Weighted average shares outstanding, basic and diluted

252,366,533

248,003,322

250,803,790

240,307,403

 

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SOURCE Precigen, Inc.

FAQ

What were the key results from Precigen's PRGN-2012 pivotal study for RRP?

In the PRGN-2012 pivotal study for RRP, 51% of patients (18 out of 35) achieved Complete Response, requiring no surgeries after treatment. 86% of patients had decreased surgical interventions in the year after treatment compared to the year prior. The therapy was well-tolerated with no dose-limiting toxicities.

When does Precigen (PGEN) expect to submit the BLA for PRGN-2012?

Precigen anticipates submitting a rolling Biologics License Application (BLA) for PRGN-2012 under an accelerated approval pathway in the second half of 2024.

How much did Precigen (PGEN) raise in its recent public offering?

In August 2024, Precigen raised approximately $31.4 million via a public offering of common stock to strengthen its cash position.

What was Precigen's (PGEN) net loss for Q2 2024?

Precigen reported a net loss of $58.8 million, or $(0.23) per basic and diluted share, for the second quarter of 2024.

How is Precigen (PGEN) reprioritizing its pipeline?

Precigen is strategically focusing on advancing its lead program PRGN-2012 for RRP. The company is pausing or discontinuing several other clinical and preclinical programs, and shutting down its ActoBio subsidiary to streamline resources.

Precigen, Inc.

NASDAQ:PGEN

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Biotechnology
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