STOCK TITAN

Sangamo Therapeutics Reports Recent Business Highlights and Fourth Quarter and Full Year 2024 Financial Results

Rhea-AI Impact
(Neutral)
Rhea-AI Sentiment
(Neutral)
Tags

Sangamo Therapeutics (NASDAQ: SGMO) reported key developments and financial results for Q4 and full year 2024. The company secured two significant neurology license agreements: a global epigenetic regulation and capsid delivery agreement with Genentech and a capsid license agreement with Astellas, raising over $100M in non-dilutive funding.

Key highlights include: FDA clearance for ST-503 IND for treating intractable pain, with patient enrollment expected mid-2025; successful nonclinical proof of concept in prion disease; and alignment with FDA on Accelerated Approval pathway for isaralgagene civaparvovec in Fabry disease.

Financial results show Q4 2024 net loss of $23.4M ($0.11/share) compared to $60.3M loss in Q4 2023. Full-year 2024 net loss was $97.9M versus $257.8M in 2023. Q4 revenues were $7.6M, up from $2.0M in Q4 2023. Cash position stood at $41.9M as of December 31, 2024.

Sangamo Therapeutics (NASDAQ: SGMO) ha riportato sviluppi chiave e risultati finanziari per il quarto trimestre e l'intero anno 2024. L'azienda ha ottenuto due importanti accordi di licenza nel campo della neurologia: un accordo globale per la regolazione epigenetica e la consegna di capsidi con Genentech e un accordo di licenza per capsidi con Astellas, raccogliendo oltre 100 milioni di dollari in finanziamenti non diluitivi.

I punti salienti includono: l'approvazione della FDA per l'IND ST-503 per il trattamento del dolore intrattabile, con l'arruolamento dei pazienti previsto per metà 2025; una prova di concetto non clinica di successo nella malattia da prioni; e un allineamento con la FDA sul percorso di approvazione accelerata per isaralgagene civaparvovec nella malattia di Fabry.

I risultati finanziari mostrano una perdita netta nel quarto trimestre 2024 di 23,4 milioni di dollari (0,11 dollari per azione) rispetto a una perdita di 60,3 milioni di dollari nel quarto trimestre 2023. La perdita netta per l'intero anno 2024 è stata di 97,9 milioni di dollari rispetto ai 257,8 milioni di dollari nel 2023. Le entrate del quarto trimestre sono state di 7,6 milioni di dollari, in aumento rispetto ai 2,0 milioni di dollari nel quarto trimestre 2023. La posizione di cassa era di 41,9 milioni di dollari al 31 dicembre 2024.

Sangamo Therapeutics (NASDAQ: SGMO) informó sobre desarrollos clave y resultados financieros para el cuarto trimestre y el año completo 2024. La compañía aseguró dos acuerdos de licencia significativos en neurología: un acuerdo global de regulación epigenética y entrega de capsides con Genentech y un acuerdo de licencia de capsides con Astellas, recaudando más de 100 millones de dólares en financiamiento no dilutivo.

Los aspectos destacados incluyen: la autorización de la FDA para el IND ST-503 para el tratamiento del dolor intratable, con la inscripción de pacientes prevista para mediados de 2025; una prueba de concepto no clínica exitosa en la enfermedad de priones; y un alineamiento con la FDA sobre el camino de Aprobación Acelerada para isaralgagene civaparvovec en la enfermedad de Fabry.

Los resultados financieros muestran una pérdida neta en el cuarto trimestre de 2024 de 23,4 millones de dólares (0,11 dólares por acción) en comparación con una pérdida de 60,3 millones de dólares en el cuarto trimestre de 2023. La pérdida neta del año completo 2024 fue de 97,9 millones de dólares frente a 257,8 millones de dólares en 2023. Los ingresos del cuarto trimestre fueron de 7,6 millones de dólares, un aumento respecto a los 2,0 millones de dólares en el cuarto trimestre de 2023. La posición de efectivo se situó en 41,9 millones de dólares al 31 de diciembre de 2024.

상가모 치료제(Sangamo Therapeutics) (NASDAQ: SGMO)는 2024년 4분기 및 전체 연도에 대한 주요 개발 사항 및 재무 결과를 보고했습니다. 이 회사는 제넨텍(Genentech)과의 글로벌 에피제네틱 조절 및 캡시드 전달 계약, 아스텔라스(Astellas)와의 캡시드 라이센스 계약 등 두 가지 중요한 신경학적 라이센스 계약을 체결하여 1억 달러 이상의 비희석 자금을 확보했습니다.

주요 하이라이트로는: 난치성 통증 치료를 위한 ST-503 IND에 대한 FDA 승인, 환자 등록이 2025년 중반에 예상됨; 프리온 질병에 대한 비임상 개념 증명의 성공; 그리고 파브리병(Fabry disease)에서 이사랄가겐 시바파르보벡(isaralgagene civaparvovec)의 가속 승인 경로에 대한 FDA와의 조율이 포함됩니다.

재무 결과는 2024년 4분기 순손실이 2,340만 달러(주당 0.11달러)로 2023년 4분기 6,030만 달러의 손실과 비교된다는 것을 보여줍니다. 2024년 전체 연도 순손실은 9,790만 달러로 2023년의 2억 5,780만 달러와 대조됩니다. 4분기 수익은 760만 달러로, 2023년 4분기의 200만 달러에서 증가했습니다. 2024년 12월 31일 기준 현금 보유액은 4,190만 달러였습니다.

Sangamo Therapeutics (NASDAQ: SGMO) a rapporté des développements clés et des résultats financiers pour le quatrième trimestre et l'année entière 2024. L'entreprise a conclu deux accords de licence significatifs en neurologie : un accord mondial de régulation épigénétique et de livraison de capsides avec Genentech et un accord de licence de capsides avec Astellas, levant plus de 100 millions de dollars en financement non dilutif.

Les points saillants incluent : l'approbation de la FDA pour l'IND ST-503 pour le traitement de la douleur intraitable, avec une inscription des patients prévue pour mi-2025 ; une preuve de concept non clinique réussie dans la maladie à prions ; et un alignement avec la FDA sur la voie d'approbation accélérée pour isaralgagene civaparvovec dans la maladie de Fabry.

Les résultats financiers montrent une perte nette de 23,4 millions de dollars au quatrième trimestre 2024 (0,11 $/action) par rapport à une perte de 60,3 millions de dollars au quatrième trimestre 2023. La perte nette pour l'année entière 2024 s'élevait à 97,9 millions de dollars contre 257,8 millions de dollars en 2023. Les revenus du quatrième trimestre s'élevaient à 7,6 millions de dollars, en hausse par rapport à 2,0 millions de dollars au quatrième trimestre 2023. La position de trésorerie était de 41,9 millions de dollars au 31 décembre 2024.

Sangamo Therapeutics (NASDAQ: SGMO) berichtete über wichtige Entwicklungen und finanzielle Ergebnisse für das vierte Quartal und das gesamte Jahr 2024. Das Unternehmen sicherte sich zwei bedeutende Lizenzvereinbarungen im Bereich Neurologie: eine globale Vereinbarung zur epigenetischen Regulierung und zur Capsid-Zustellung mit Genentech sowie eine Capsid-Lizenzvereinbarung mit Astellas, wodurch über 100 Millionen Dollar an nicht verwässernder Finanzierung eingeworben wurden.

Zu den wichtigsten Punkten gehören: die Genehmigung der FDA für ST-503 IND zur Behandlung von therapieresistenten Schmerzen, mit einer erwarteten Patientenaufnahme Mitte 2025; ein erfolgreicher nichtklinischer Machbarkeitsnachweis bei Prionerkrankungen; und die Abstimmung mit der FDA über den beschleunigten Genehmigungsweg für isaralgagene civaparvovec bei der Fabry-Krankheit.

Die finanziellen Ergebnisse zeigen einen Nettoverlust von 23,4 Millionen Dollar im vierten Quartal 2024 (0,11 Dollar/Aktie) im Vergleich zu einem Verlust von 60,3 Millionen Dollar im vierten Quartal 2023. Der Nettoverlust für das gesamte Jahr 2024 betrug 97,9 Millionen Dollar gegenüber 257,8 Millionen Dollar im Jahr 2023. Die Einnahmen im vierten Quartal betrugen 7,6 Millionen Dollar, ein Anstieg von 2,0 Millionen Dollar im vierten Quartal 2023. Die Liquiditätsposition betrug zum 31. Dezember 2024 41,9 Millionen Dollar.

Positive
  • FDA clearance for ST-503 IND application for neuropathic pain treatment
  • Secured two major neurology license agreements with potential for $1.3B in milestone payments
  • Raised over $100M in non-dilutive funding through license fees and milestone payments
  • Significant reduction in net loss from $257.8M in 2023 to $97.9M in 2024
  • FDA agreement on Accelerated Approval pathway for Fabry disease treatment
Negative
  • Cash runway only extends into mid-Q2 2025, indicating potential near-term funding needs
  • Revenue decrease from $176.2M in 2023 to $57.8M in 2024
  • Loss of Pfizer collaboration for hemophilia A gene therapy program
  • Termination of Biogen and Novartis collaboration agreements in 2023

Insights

Sangamo Therapeutics' Q4 and FY2024 results reveal a company making strategic progress amid financial constraints. The quarterly net loss improved to $23.4 million ($0.11/share) compared to $60.3 million in Q4 2023, while full-year losses narrowed to $97.9 million versus $257.8 million in 2023.

Q4 revenues increased to $7.6 million (vs $2.0 million in Q4 2023), primarily from new licensing agreements with Astellas and Genentech. However, annual revenues declined substantially to $57.8 million from $176.2 million in 2023, reflecting terminated collaborations with Biogen and Novartis.

The most pressing concern is Sangamo's cash position of $41.9 million (down from $81 million YoY), which management indicates will only fund operations into mid-Q2 2025. This creates urgent near-term financing pressure despite raising over $100 million in 2024 through licensing fees and equity financing.

On the positive side, Sangamo secured two significant neurology licensing agreements with Genentech and Astellas, featuring substantial milestone potential, and received FDA clearance for its ST-503 IND for neuropathic pain. Additionally, the company achieved a critical regulatory breakthrough with the FDA agreeing to an Accelerated Approval pathway for its Fabry disease therapy, potentially reducing time to approval by three years.

Sangamo's pipeline is advancing with promising clinical data for isaralgagene civaparvovec in Fabry disease showing sustained benefit and improvements in kidney function. However, Pfizer's termination of their hemophilia A collaboration creates uncertainty for that program.

The company's strategic realignment toward neurology and Fabry disease appears sound, but execution depends entirely on securing additional funding in the immediate future.

Sangamo's pipeline advancements demonstrate significant scientific progress, particularly in their prioritized neurology programs. The FDA clearance of the ST-503 IND application represents a milestone as the company's first neurology program to reach clinical-stage development, targeting the substantial unmet need in chronic neuropathic pain.

The prion disease program shows impressive preclinical results, with zinc finger repressors (ZFRs) demonstrating ability to reduce prion expression and extend survival in mouse models, even when administered post-symptomatically. The successful translation of this approach to non-human primates with widespread brain delivery via their proprietary STAC-BBB capsid technology indicates potential clinical translatability.

Their proprietary STAC-BBB capsid technology has clearly attracted industry validation through multiple licensing deals, suggesting its potential value in addressing blood-brain barrier challenges that have historically neurological gene therapy approaches.

The Fabry disease program continues to generate compelling clinical evidence with the updated Phase 1/2 STAAR study data showing sustained α-Gal A expression for nearly four years in the longest-treated patients. Particularly noteworthy is the positive mean eGFR slope of 3.061 mL/min/1.73m2/year, indicating improved kidney function rather than the decline typically observed in untreated Fabry patients. The fact that all 18 patients initially on enzyme replacement therapy have successfully discontinued and remained off ERT for extended periods supports the potential for this one-time treatment to replace chronic therapy.

The FDA's agreement on an Accelerated Approval pathway using the existing Phase 1/2 data with eGFR slope as an intermediate endpoint represents a significant regulatory achievement, potentially saving years of development time and reducing capital requirements. This positions isaralgagene civaparvovec for a potential BLA submission in H2 2025, assuming successful business development negotiations can resolve the company's funding constraints.

Continued to advance our prioritized neurology genomic medicine pipeline towards the clinic.

Announced two neurology license agreements with blue-chip pharma companies, including a global epigenetic regulation and capsid delivery license agreement with Genentech in August 2024 to develop novel genomic medicines for neurodegenerative diseases and a capsid license agreement with Astellas in December 2024 to deliver genomic medicines for up to five neurological disease targets.

Raised over $100 million in funding in 2024 through non-dilutive license fees and milestone payments, as well as equity financing.

Investigational new drug (IND) application cleared by U.S. Food and Drug Administration (FDA) for ST-503 for treatment of intractable pain due to idiopathic small fiber neuropathy (iSFN), a type of chronic neuropathic pain. Expect to commence patient enrollment and dosing in mid-2025.

Demonstrated nonclinical proof of concept in prion disease. A single intravenous infusion of Sangamo’s zinc finger repressor (ZFR) significantly reduced expression of prion mRNA and protein in the mouse brain and extended mouse survival.

Aligned with FDA on clear regulatory pathway to Accelerated Approval for isaralgagene civaparvovec in Fabry disease, using expected data from ongoing Phase 1/2 STAAR study, avoiding requirement for additional registrational study and accelerating estimated time to potential approval by approximately three years.

Announced updated Phase 1/2 STAAR study data that showed sustained benefit, improvements in kidney function and favorable safety profile.

RICHMOND, Calif.--(BUSINESS WIRE)-- Sangamo Therapeutics, Inc. (Nasdaq: SGMO), a genomic medicine company, today reported recent business highlights and fourth quarter and full year 2024 financial results.

“I am pleased with Sangamo’s pipeline progress since the start of 2024. We advanced our two prioritized neurology therapies towards the clinic, securing our first ever neurology IND; we showed we are a collaborator of choice for neurotropic capsids, with the announcement of two blue-chip pharma agreements for our STAC-BBB capsid, with negotiations advancing for a third potential agreement; and we have a clear regulatory pathway to Accelerated Approval in Fabry disease, which could reduce the time to potential approval by approximately three years,” said Sandy Macrae, Chief Executive Officer of Sangamo Therapeutics. “We believe our neurology pipeline represents important potential value. In addition, we continue to engage in Fabry business development negotiations, in an effort to capitalize the business for the future. This will be an important year for the Company as we plan to begin patient enrollment and dosing in mid-2025 for our clinical study in iSFN, which we believe has the potential to transform the chronic neuropathic pain landscape, and as we prepare for an anticipated BLA submission in Fabry disease in the second half of the year.”

Recent Business Highlights

Corporate Updates

  • Announced in December a capsid license agreement with Astellas Gene Therapies, Inc. (Astellas) to deliver genomic medicines for neurological diseases. Agreement grants Astellas a worldwide exclusive license to STAC-BBB for up to five potential neurological disease targets. Received a $20 million upfront license fee from Astellas and eligible to earn up to $1.3 billion in additional licensed target fees and milestone payments across all five potential neurology disease targets, as well as tiered royalties on potential net sales.
  • Announced in December that Sangamo is scheduled to regain full rights to giroctocogene fitelparvovec, an investigational gene therapy product candidate for the treatment of adults with moderately severe to severe hemophilia A that it has co-developed with, and licensed to, Pfizer, Inc. (Pfizer), following a decision by Pfizer to terminate the global collaboration and license agreement between the parties. Sangamo continues to explore how to maximize the value of the SB-525 program, including a search for a potential new collaboration partner.

Core Neurology Pipeline

Chronic Neuropathic Pain – ST-503

  • IND application cleared by the FDA for ST-503, an investigational epigenetic regulator for the treatment of intractable pain due to iSFN, a type of chronic neuropathic pain.
  • Preparing for a Phase 1/2 study of ST-503 to assess the safety, tolerability and preliminary efficacy of a one-time dose administered intrathecally to patients with intractable pain due to iSFN.
  • Expect to commence patient enrollment and dosing in mid-2025, with preliminary proof of efficacy data anticipated in Q4 2026.

Prion Disease

  • Clinical Trial Authorisation (CTA) enabling activities continue to advance for Sangamo’s product candidate to treat prion disease, leveraging STAC-BBB.
  • Published a manuscript in bioRxiv titled, “Zinc Finger Repressors mediate widespread prion depletion from the nonhuman primate brain and profoundly extend survival in prion disease mice” demonstrating nonclinical proof of concept for this approach. A single intravenous infusion of Sangamo’s ZFR significantly reduced expression of prion mRNA and protein in the mouse brain, extended mouse survival and improved an array of molecular, histological, biomarker and behavior readouts – even when administered post-symptomatically to mice with prion disease. In addition, a single intravenous administration of the prion ZFR, delivered via STAC-BBB to nonhuman primates, resulted in potent and widespread reduction of prion expression in transduced neurons throughout the brain.
  • A CTA submission is expected in Q1 2026, with preliminary clinical data anticipated in Q4 2026.

Novel Adeno-Associated Virus (AAV) Capsid Delivery Technology

  • Actively engaged in advanced contract negotiations with a potential collaborator for a third STAC-BBB license agreement for use in delivering intravenously administered genomic medicines for certain specified neurological diseases.

Clinical – Fabry Disease

  • Presented updated Phase 1/2 STAAR study data at the 21st Annual WORLDSymposium in San Diego, CA in February 2025 showing sustained benefit, improvements in kidney function and a favorable safety profile, following a single administration of isaralgagene civaparvovec in 33 adults with Fabry disease.
  • Elevated expression of alpha-galactosidase A (α-Gal A) activity maintained for nearly four years for the longest treated patient as of the September 12, 2024 data cutoff date.
  • Positive mean estimated glomerular filtration rate (eGFR) slope of 3.061 mL/min/1.73m2/year (95% confidence interval: 0.863, 5.258) was observed in the 23 patients who had reached at least one-year follow-up, indicating notable improvements in renal function.
  • All 18 patients who began the study on enzyme replacement therapy (ERT) have been withdrawn from, and remain off, ERT as of March 17, 2025.
  • Significant improvements continued to be observed in the short form-36 (SF-36) quality of life (QoL) scores reported, with a mean change in General Health score of 10.6. Significant improvements in physical component, bodily pain, physical, vitality, social function, and emotional SF-36 scores were also observed.
  • Enrollment and dosing are complete in the Phase 1/2 STAAR study.
  • The FDA has provided a clear regulatory pathway to Accelerated Approval for isaralgagene civaparvovec, agreeing that data from the ongoing Phase 1/2 STAAR study can serve as the primary basis for approval under the Accelerated Approval Program, using eGFR slope at 52 weeks across all patients as an intermediate clinical endpoint.
  • The 52-week eGFR slope data from all enrolled patients in the Phase 1/2 STAAR study will be available in the first half of 2025. A potential Biologics License Application (BLA) submission is anticipated in the second half of 2025.
  • Sangamo is advancing BLA preparation activities for isaralgagene civaparvovec, while continuing to engage in business development negotiations for a potential Fabry commercialization agreement.

Fourth Quarter and Full Year 2024 Financial Results

Consolidated net loss for the fourth quarter ended December 31, 2024 was $23.4 million, or $0.11 per share, compared to consolidated net loss of $60.3 million, or $0.34 per share, for the same period in 2023. For the year ended December 31, 2024, consolidated net loss was $97.9 million, or $0.49 per share, compared to consolidated net loss of $257.8 million, or $1.48 per share, for the year ended December 31, 2023.

Revenues

Revenues for the fourth quarter ended December 31, 2024 were $7.6 million, compared to $2.0 million for the same period in 2023.

The increase of $5.5 million in revenues was primarily attributed to $6.5 million and $0.8 million in revenues relating to our license agreements with Astellas Gene Therapies, Inc., or Astellas, and Genentech, Inc., respectively, partially offset by revenue decreases in other collaborations.

Revenues were $57.8 million in 2024, compared to $176.2 million in 2023.

The decrease of $118.4 million in revenues in 2024 compared to 2023 was primarily attributed to decreases of $134.8 million and $12.2 million in revenues relating to our collaboration agreements with Biogen and Novartis, respectively, due to the termination of these collaboration agreements in June 2023, a decrease of $20.5 million in revenue relating to our collaboration agreement with Kite, which expired pursuant to its terms in April 2024, a decrease of $4.7 million in revenue relating to our license agreements with Sigma and Ligand, and a decrease of $2.7 million in revenue relating to our other license agreements. These decreases were partially offset by $50.0 million in revenue relating to our license agreement with Genentech and $6.5 million in revenue relating to our license agreement with Astellas.

GAAP and Non-GAAP Operating Expenses

Three Months Ended Year Ended
December 31, December 31,
(In millions)

 

2024

 

 

2023

 

 

2024

 

 

2023

 

 
Research and development

$

23.6

 

$

50.7

 

$

111.5

 

$

234.0

 

General and administrative

 

9.9

 

 

13.1

 

 

44.8

 

 

61.2

 

Impairment of long-lived assets

 

-

 

 

0.3

 

 

5.5

 

 

65.5

 

Impairment of goodwill and indefinite-lived intangible assets

 

-

 

 

-

 

 

-

 

 

89.5

 

Total operating expenses

 

33.5

 

 

64.1

 

 

161.8

 

 

450.2

 

Impairment of long-lived assets

 

-

 

 

(0.3

)

 

(5.5

)

 

(65.5

)

Impairment of goodwill and indefinite-lived intangible assets

 

-

 

 

-

 

 

-

 

 

(89.5

)

Depreciation and amortization

 

(1.2

)

 

(1.8

)

 

(5.1

)

 

(15.1

)

Stock-based compensation expense

 

(3.3

)

 

(6.1

)

 

(12.4

)

 

(27.4

)

Non-GAAP operating expenses

$

29.0

 

$

55.9

 

$

138.8

 

$

252.7

 

Total operating expenses on a GAAP basis for the fourth quarter ended December 31, 2024 were $33.5 million compared to $64.1 million for the same period in 2023. Non-GAAP operating expenses, which exclude impairment charges, depreciation and amortization and stock-based compensation expense as shown in the reconciliation table above, for the fourth quarter ended December 31, 2024 were $29.0 million, compared to $55.9 million for the same period in 2023.

Total operating expenses on a GAAP basis in 2024 were $161.8 million compared to $450.2 million in 2023. Non-GAAP operating expenses, which exclude impairment charges, depreciation and amortization and stock-based compensation expense as shown in the reconciliation table above, were $138.8 million in 2024 compared to $252.7 million in 2023.

The decrease in total operating expenses on a GAAP basis was primarily driven by cost reductions resulting from the strategic realignment of the business, which included a lower headcount due to the restructuring of operations and corresponding reductions in workforce announced during 2023. Additionally, the decrease reflects intentional reprioritization of research and development investments, with a focused shift toward advancing the neurology pipeline. Other contributing factors included lower impairment charges recorded in the current year, lower preclinical and clinical expenses due to program deferrals, a decrease in restructuring charges related to the 2023 restructuring of operations, a decrease in depreciation due to reduced carrying values as a result of impairment charges recorded in 2023, and a decrease in external professional services, facilities, and infrastructure-related costs.

Cash and Cash Equivalents

Cash and cash equivalents as of December 31, 2024 were $41.9 million, compared to cash, cash equivalents and marketable securities of $81.0 million as of December 31, 2023. Based on our current operating plan, we believe that our cash and cash equivalents as of December 31, 2024, together with $10.1 million generated to date through our at-the-market offering program in 2025 and the $5.0 million payment expected from Pfizer by the end of March, will be sufficient to fund our planned operations into the middle of the second quarter of 2025.

Financial Guidance for 2025

  • 2025 operating expenses on a non-GAAP basis are expected to be roughly in line with 2024, reflecting our intention to operate a lean neurology-focused business and to continue advancing isaralgagene civaparvovec towards a potential BLA submission, while engaging in business development negotiations for a potential Fabry commercialization agreement.
  • On a GAAP basis, we expect total operating expenses in the range of approximately $135 million to $155 million in 2025, which includes estimated non-cash stock-based compensation expense, and depreciation and amortization.
  • We expect non-GAAP total operating expenses, excluding estimated non-cash stock-based compensation expense of approximately $7 million, and estimated depreciation and amortization of approximately $3 million, in the range of approximately $125 million to $145 million in 2025, consistent with the prior year.

Upcoming Events

Sangamo plans to participate in the following events:

  • Jefferies Global Healthcare Conference, June 3-5, 2025
  • Wells Fargo Healthcare Conference, September 3-5, 2025

Access links for available webcasts for investor conferences will be available on the Sangamo website in the Investors and Media section under Events. Available materials will be found on the Sangamo website after the event under Presentations.

Conference Call

The Sangamo management team will hold a corporate call to further discuss program and financial updates on Monday, March 17, at 4:30pm Eastern Time.

Participants should register for, and access, the call using this link. While not required, it is recommended you join 10 minutes prior to the event start. Once registered, participants will be given the option to either dial into the call with the number and unique passcode provided or to use the dial-out option to connect their phone instantly.

An updated corporate presentation is available in the Investors and Media section under Presentations.

The link to access the live webcast can also be found on the Sangamo website in the Investors and Media section under Events. A replay will be available following the conference call, accessible at the same link.

About Sangamo Therapeutics

Sangamo Therapeutics is a genomic medicine company dedicated to translating ground-breaking science into medicines that transform the lives of patients and families afflicted with serious neurological diseases who do not have adequate or any treatment options. Sangamo believes that its zinc finger epigenetic regulators are ideally suited to potentially address devastating neurological disorders and that its capsid discovery platform can expand delivery beyond currently available intrathecal delivery capsids, including in the central nervous system. Sangamo’s pipeline also includes multiple partnered programs and programs with opportunities for partnership and investment. To learn more, visit www.sangamo.com and connect with us on LinkedIn and X.

Forward-Looking Statements

This press release contains forward-looking statements regarding our current expectations. These forward-looking statements include, without limitation, statements relating to: Sangamo’s cash runway and ability to continue to operate as a going concern; the therapeutic and commercial potential and value of Sangamo’s product candidates, including the durability of therapeutic effects, the therapeutic and commercial potential and value of technologies used by Sangamo in its product candidates; the potential of its adeno-associated virus capsid delivery platform; the potential for isaralgagene civaparvovec to qualify for the FDA’s Accelerated Approval program, including the adequacy of data generated in the Phase 1/2 STAAR study to support any such approval, expectations concerning the availability of additional data to support a potential BLA submission for isaralgagene civaparvovec, and the timing of such submission, and the potential to accelerate the expected timeline to approval; the anticipated advancement of isaralgagene civaparvovec to registration, including Sangamo’s plans to seek a potential commercialization partner; Sangamo’s ability to realize the expected benefits of the license agreements with Genentech and Astellas, including the potential for Sangamo to receive licensed target fees and milestone payments and royalties; Sangamo’s ability to establish and maintain collaborations and strategic partnerships and realize the expected benefits of such arrangements, including its ability to secure a commercialization partner for its Fabry disease program and additional collaborations with respect to Sangamo’s hemophilia A program, STAC-BBB capsid delivery platform and epigenetic regulation capabilities; anticipated revenues from existing and new collaborations and the timing thereof; the anticipated plans and timelines of Sangamo and its collaborators in conducting our ongoing and potential future clinical trials and presenting clinical data from such clinical trials; the advancement of Sangamo’s preclinical neurology programs, including the potential of ST-503 to transform the chronic neuropathic pain landscape, plans to initiate patient enrollment and dosing for ST-503 and announcement of such preliminary proof of efficacy data, and anticipated prion disease CTA submission and announcement of related preliminary clinical data; Sangamo’s estimates regarding the sufficiency of its cash resources and its expenses, capital requirements and need for substantial additional financing; Sangamo’s 2025 financial guidance related to GAAP and non-GAAP total operating expenses, impairments and non-cash stock-based compensation expense, depreciation and amortization; plans to participate in industry and investor conferences; and other statements that are not historical fact. These statements are not guarantees of future performance and are subject to certain risks and uncertainties that are difficult to predict. Factors that could cause actual results to differ include, but are not limited to, risks and uncertainties related to Sangamo’s lack of capital resources and need for substantial additional funding to execute its operating plan and to continue to operate as a going concern, including the risk that Sangamo will be unable to obtain funding or partnerships, in particular for its Fabry disease program, or additional collaboration partners necessary to advance its preclinical and clinical programs and to otherwise operate as a going concern, in which case Sangamo may be required to cease operations entirely, liquidate all or a portion of its assets and/or seek protection under the U.S. Bankruptcy Code, the potential for collaborators and licensees to breach or terminate their agreements with Sangamo; the potential for Sangamo to fail to realize its expected benefits from its collaboration and license agreements; the uncertain and costly research and development process, including the risk that preclinical results may not be indicative of results in any future clinical trials; the effects of macroeconomic factors or financial challenges, including as a result of the ongoing overseas conflicts, tariffs, geopolitical instability, inflation and fluctuations in interest rates, on the global business environment, healthcare systems and business and operations of Sangamo and its collaborators, including the initiation and operation of clinical trials; the impacts of clinical trial delays, pauses and holds on clinical trial timelines and commercialization of product candidates; the uncertain timing and unpredictable nature of clinical trial results, including the risk that therapeutic effects in the Phase 3 AFFINE trial will not be durable in patients as well as the risk that the therapeutic effects observed in the latest preliminary clinical data from the Phase 1/2 STAAR study will not be durable in patients and that final clinical trial data from the study will not validate the safety and efficacy of isaralgagene civaparvovec, including that the 52-week data from the Phase 1/2 STAAR study will not support a BLA submission and/or that the 104-week data from such study will not verify the clinical benefit of isaralgagene civaparvovec or support FDA approval, and that the patients withdrawn from ERT will remain off ERT; the unpredictable regulatory approval process for product candidates across multiple regulatory authorities; reliance on results of early clinical trials, which results are not necessarily predictive of future clinical trial results, including the results of any registrational trial of Sangamo’s product candidates; the potential for technological developments that obviate technologies used by Sangamo; Sangamo’s reliance on collaborators and its potential inability to secure additional collaborations, and Sangamo’s ability to achieve expected future operating results.

All forward-looking statements about Sangamo’s future plans and expectations, including Sangamo’s financial guidance, are subject to Sangamo’s ability to secure adequate additional funding. There can be no assurance that Sangamo and its collaborators will be able to develop commercially viable products or that Sangamo will earn any milestone or royalty payments under its collaboration agreements. Actual results may differ materially from those projected in these forward-looking statements due to the risks and uncertainties described above and other risks and uncertainties that exist in the operations and business environments of Sangamo and its collaborators. These risks and uncertainties are described more fully in Sangamo’s Securities and Exchange Commission, or SEC, filings and reports, including in Sangamo’s Annual Report on Form 10-K for the year ended December 31, 2024, and subsequent filings and reports that Sangamo makes from time to time with the SEC. Forward-looking statements contained in this announcement are made as of this date, and Sangamo undertakes no duty to update such information except as required under applicable law.

Non-GAAP Financial Measures

To supplement our financial results and guidance presented in accordance with GAAP, we present non-GAAP operating expenses, which excludes depreciation and amortization, stock-based compensation expense and impairment of goodwill, indefinite-lived intangible assets and long-lived assets from GAAP operating expenses. We believe that this non-GAAP financial measure, when considered together with our financial information prepared in accordance with GAAP, can enhance investors’ and analysts’ ability to meaningfully compare our results from period to period and to our forward-looking guidance, and to identify operating trends in our business. We have excluded depreciation and amortization, and stock-based compensation expense because they are non-cash expenses that may vary significantly from period to period as a result of changes not directly or immediately related to the operational performance for the periods presented, and we have excluded impairment of goodwill, indefinite-lived intangible assets and long-lived assets to facilitate a more meaningful evaluation of our current operating performance and comparisons to our operating performance in other periods. This non-GAAP financial measure is in addition to, not a substitute for, or superior to, measures of financial performance prepared in accordance with GAAP. We encourage investors to carefully consider our results under GAAP, as well as our supplemental non-GAAP financial information, to more fully understand our business.

SELECTED CONSOLIDATED FINANCIAL DATA
(Unaudited; in thousands, except per share amounts)
 
Statement of Operations Data:
Three months ended Year Ended
December 31, December 31,

 

 

2024

 

 

 

2023

 

 

 

2024

 

 

 

2023

 

 
Revenues

$

7,551

 

$

2,042

 

$

57,800

 

$

176,232

 

Operating expenses:
Research and development

 

23,675

 

 

50,706

 

 

111,521

 

 

234,057

 

General and administrative

 

9,866

 

 

13,099

 

 

44,727

 

 

61,167

 

Impairment of long-lived assets

 

-

 

 

296

 

 

5,521

 

 

65,528

 

Impairment of goodwill and indefinite-lived intangible assets

 

-

 

 

-

 

 

-

 

 

89,485

 

Total operating expenses

 

33,541

 

 

64,101

 

 

161,769

 

 

450,237

 

Loss from operations

 

(25,990

)

 

(62,059

)

 

(103,969

)

 

(274,005

)

Interest and other income, net

 

2,167

 

 

1,491

 

 

5,861

 

 

11,102

 

Loss before income taxes

 

(23,823

)

 

(60,568

)

 

(98,108

)

 

(262,903

)

Income tax benefit

 

(427

)

 

(272

)

 

(167

)

 

(5,072

)

Net loss

$

(23,396

)

$

(60,296

)

$

(97,941

)

$

(257,831

)

Basic and diluted net loss per share

$

(0.11

)

$

(0.34

)

$

(0.49

)

$

(1.48

)

Shares used in computing basic and diluted net loss per share

 

210,185

 

 

177,619

 

 

201,699

 

 

174,444

 

 
 
Selected Balance Sheet Data:
December 31, 2024 December 31, 2023
 
Cash, cash equivalents and marketable securities

$

41,918

 

$

81,002

 

Total assets

$

101,635

 

$

165,320

 

Total stockholders' equity

$

22,770

 

$

82,887

 

 

Investor Relations & Media Inquiries

Louise Wilkie

ir@sangamo.com

media@sangamo.com

Source: Sangamo Therapeutics, Inc.

FAQ

What is the financial impact of Sangamo's (SGMO) neurology license agreements with Genentech and Astellas in 2024?

The agreements contributed to over $100M in funding through non-dilutive license fees and milestone payments. Astellas agreement includes $20M upfront fee with potential for $1.3B in additional fees and milestone payments.

When will Sangamo (SGMO) begin patient enrollment for ST-503 clinical trials?

Patient enrollment and dosing for ST-503 trials are expected to commence in mid-2025, with preliminary proof of efficacy data anticipated in Q4 2026.

What are the latest Phase 1/2 STAAR study results for Sangamo's (SGMO) Fabry disease treatment?

Updated results showed sustained benefits for up to four years, improved kidney function with positive eGFR slope of 3.061 mL/min/1.73m2/year, and all 18 ERT patients successfully discontinued enzyme replacement therapy.

What is Sangamo's (SGMO) cash runway as of December 2024?

Cash position of $41.9M as of December 31, 2024, expected to fund operations into mid-Q2 2025, including $10.1M from ATM offering in 2025 and expected $5M Pfizer payment.
Sangamo Therapeutics Inc

NASDAQ:SGMO

SGMO Rankings

SGMO Latest News

SGMO Stock Data

157.32M
219.12M
2.17%
27.49%
12.7%
Biotechnology
Biological Products, (no Disgnostic Substances)
Link
United States
RICHMOND