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Freeline

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uuid00054hr

Namestring
Freeline
Legal namestring
Spur Therapeutics
Websiteurl
freeline.life
Company typeenum
Private
Founded yearint
2015
Descriptiontext

Freeline Therapeutics, now operating as Spur Therapeutics, is a clinical-stage biotechnology company headquartered in Stevenage, United Kingdom, founded in 2015. The company is developing adeno-associated virus (AAV)-based gene therapies designed to deliver functional genes via single-dose administration, with a stated engineering focus on optimizing gene expression, vector packaging, and delivery to target tissues. Its lead candidate, avigbagene parvec (FLT201), is an investigational AAV gene therapy for Gaucher disease type 1 — a rare lysosomal storage disorder — currently in the GALILEO-3 Phase 3 registrational trial, with completed GALILEO-1 and GALILEO-2 studies providing two-year follow-up data on clinical efficacy and bone health markers. The company is also developing a Parkinson's disease gene therapy program and has stated intent to expand into forms of dementia and certain cardiovascular diseases, signaling a strategic broadening beyond its initial rare-disease focus.

The company is pre-revenue with no commercialized products; revenue generation will depend on successful regulatory approval and subsequent commercialization of its gene therapy candidates. To date, the company has been funded through a combination of private financing rounds and a March 2022 registered direct offering of American Depositary Shares ($26.1M), having previously listed on NASDAQ under the ticker FRLN before delisting and rebranding to Spur Therapeutics. The go-to-market motion is enterprise/field-sales oriented in the long term, advancing candidates through FDA regulatory pathways and targeting rare-disease patients through clinical research, with planned distribution via specialty channels upon approval. The customer base — once commercialized — will center on patients with Gaucher disease type 1 (primary) and Parkinson's disease (secondary), positioning the company in the orphan and large chronic-disease gene therapy segments respectively.

Short descriptiontext

Spur Therapeutics (formerly Freeline) is a clinical-stage UK biotech developing AAV-based single-dose gene therapies, with lead candidate FLT201 in Phase 3 for Gaucher disease type 1 and a pipeline extending into Parkinson's and other chronic conditions. The company is pre-revenue, targeting rare-disease and neurodegenerative patients upon regulatory approval.

Operating statusenum
Operating
Ownership categoryenum
Headcount rangeband
251–500
akta.pro rankint
HeadquartersStevenage, United Kingdom
HQ citystring
Stevenage
HQ countrystring
United Kingdom
HQ regionstring
Europe
Markets served

Serves global market

Keyword5 values
gene therapy, AAV vectors, rare disease therapeutics, biotechnology pharmaceuticals, clinical development
Industry4 codes
1AAV Vector Gene Therapy Developers
CodeHLAAACAAPrimaryYes
2Gene Therapy for Rare/Monogenic Diseases
CodeHLAAACAEPrimaryNo
3Neurology/CNS Gene Therapies
CodeHLAAACAHPrimaryNo
4Gene Therapy Regulatory, Pharmacovigilance & Clinical Operations Services
CodeHLAAACAMPrimaryNo
NAICS code1 code
  • Research and Development in Biotechnology (except Nanobiotechnology)541714
SIC code1 code
  • Services-Commercial Physical & Biological Research8731
Product category
Gene Therapy
GTM motion1 record

Each record includes

Type, Description, Source

Revenue model1 record
1Gene Therapy Product Commercialization
TypeOne Time License
Description

Pre-revenue clinical-stage biotech. Developing gene therapy candidates (FLT201 for Gaucher disease, Parkinson's programs) that will generate revenue upon FDA approval and commercial launch. Currently funded through registered direct offerings and other corporate activities.

spurtherapeutics.com
Marketing channels2 records

Each record includes

Title, Type, Stage, Description, Source

Distribution channels1 record

Each record includes

Title, Type, Scope, Target buyer, Description, Source

Cost components4 values
Technology or R&D, Personnel, Operations, Marketing or Sales
GTM typeB2B
B2B
Offering typeHardware or Manufacturing
Hardware or Manufacturing
Core offering1 text field

Freeline (now Spur Therapeutics) is a clinical-stage biotechnology company developing transformative AAV-based gene therapies for systemic debilitating diseases. Its lead candidate, avigbagene parvec (FLT201), is an investigational AAV gene therapy for Gaucher disease type 1 currently advancing through the GALILEO-3 Phase 3 registrational trial. The company is also building a Parkinson's disease gene therapy program and expanding toward additional widespread conditions.

Differentiator
Functional benefit
Problem solved
Quantifiable outcome1 value
  • Two-year follow-up data demonstrating avigbagene parvec (FLT201) efficacy and impact on bone health markers in adults with Gaucher disease type 1 from GALILEO-1 and GALILEO-2 trials
Product overview1 text field

Spur Therapeutics (formerly Freeline Therapeutics) is a clinical-stage biotech developing gene therapies. The company's pipeline consists of avigbagene parvec (FLT201), an AAV gene therapy for Gaucher disease type 1 currently in Phase 3 registrational trials (GALILEO-3), and a Parkinson's Disease program focused on disease-modifying treatments. The company is expanding its gene therapy approach from rare diseases toward more widespread conditions including forms of Parkinson’s and dementia, and certain cardiovascular diseases.

Product and service1 record
1avigbagene parvec (FLT201)
Scale indicator3 records

Each record includes

Type, Value, Description, Source

Recent move6 records

Each record includes

Date, Type, Title, Description, Source

Expansion highlight5 records

Each record includes

Type, Description

Peers10 records
TypeDirect peer
Description

Clinical-stage AAV gene therapy company focused on rare monogenic CNS diseases; comparable in scale, modality, and pipeline focus on AAV delivery for rare and neurological indications.

TypeDirect peer
Description

Commercial-stage AAV gene therapy developer with Roctavian (valoctocogene roxaparvovec) for hemophilia A; directly comparable as a clinical-to-commercial AAV gene therapy company pursuing registrational approvals for rare diseases.

TypeDirect peer
Description

AAV gene therapy developer with a Phase 3 program (etranacogene dezaparvovec partnered with CSL Behring for hemophilia B); closely comparable as an AAV-focused company advancing through pivotal trials in rare monogenic diseases.

TypeDirect peer
Description

Pure-play AAV gene therapy platform company with internal pipeline and licensing model; comparable as a technology-platform peer supplying and developing AAV-based therapeutics across rare and CNS indications.

TypeDirect peer
Description

Clinical-stage gene therapy company developing AAV-based therapies primarily for CNS/neurological disorders including Parkinson's disease; directly comparable as a fellow AAV developer pursuing Parkinson's with disease-modifying ambition.

TypeDirect peer
Description

Clinical-stage AAV gene therapy developer focused on Duchenne muscular dystrophy and other rare muscle/CNS disorders; comparable as a clinical-stage AAV pure-play with similar scale and regulatory pathway focus.

TypeDirect peer
Description

Clinical-stage AAV gene therapy company with programs in cardiac and CNS rare diseases; comparable as a recent-era AAV developer expanding beyond monogenic rare diseases into broader indications like cardiovascular.

TypeDirect peer
Description

Clinical-stage AAV gene therapy company with a CNS-focused pipeline; comparable in modality, clinical stage, and rare/neurological disease focus to Spur Therapeutics.

TypeBroad incumbent
Description

Through Genzyme, markets Cerezyme/imiglucerase — the dominant enzyme replacement therapy for Gaucher disease type 1; the established incumbent Spur would need to displace or convert patients from this franchise.

TypeEmerging player
Description

AAV-based gene therapy developer (now part of Eli Lilly) focused on GBA1-linked Parkinson's disease and other CNS/neurodegenerative disorders; directly overlaps with Spur's Parkinson's program targeting disease modification.

Market position
Strengths4 records

Each record includes

Headline, Details, Source

Weaknesses4 records

Each record includes

Headline, Details, Source

Competitive moat3 records

Each record includes

Type, Details

Key risks6 records

Each record includes

Headline, Details, Source

Key highlights6 records

Each record includes

Headline, Details, Source

Customer concentration

Classification, Details

Segment2 records

Each record includes

Title, Type, Primary, Description, Pain point addressed, Use case, Source

Ideal customer profile2 records

Each record includes

Profile, Firmographic size, Sales motion, Sales cycle length, Buying structure, Purchase trigger, Buyer persona, Geography, Industry vertical, Primary use case, Description, Pain points, Evidence proof points, Target buyer

Technology focused
Yes
API detail
Has APIbool
No

Docs URL, Description

AI maturity
App detail

Has app

Feature2 records

Each record includes

Title, Differentiator, Description, Source

Core technology
Revenue estimate
Valuation estimate
Number of profiles
Profiles7 records

Each record includes

Name, Designation, Designation category, Overview, Profile commentary, Source

No data
No data
Funding overview

Funding stage, Last funding date, Total funding USD

Funding rounds7 records

Each record includes

Round, Amount USD, Date, Pre money valuation, Total investors, Investors, News

Investors9 records

Each record includes

Name, Type, Date of entry, Rounds participated, Website

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Each record includes

Name, Acquisition type, Announced date, Completed date, Status, Website, News

Investment

Each record includes

Name, Round, Announced date, Lead investor, Website, News

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Freeline

Gene Therapyfreeline.life

Spur Therapeutics (formerly Freeline) is a clinical-stage UK biotech developing AAV-based single-dose gene therapies, with lead candidate FLT201 in Phase 3 for Gaucher disease type 1 and a pipeline extending into Parkinson's and other chronic conditions. The company is pre-revenue, targeting rare-disease and neurodegenerative patients upon regulatory approval.

What Freeline does

Freeline Therapeutics, now operating as Spur Therapeutics, is a clinical-stage biotechnology company headquartered in Stevenage, United Kingdom, founded in 2015. The company is developing adeno-associated virus (AAV)-based gene therapies designed to deliver functional genes via single-dose administration, with a stated engineering focus on optimizing gene expression, vector packaging, and delivery to target tissues. Its lead candidate, avigbagene parvec (FLT201), is an investigational AAV gene therapy for Gaucher disease type 1 — a rare lysosomal storage disorder — currently in the GALILEO-3 Phase 3 registrational trial, with completed GALILEO-1 and GALILEO-2 studies providing two-year follow-up data on clinical efficacy and bone health markers. The company is also developing a Parkinson's disease gene therapy program and has stated intent to expand into forms of dementia and certain cardiovascular diseases, signaling a strategic broadening beyond its initial rare-disease focus.

The company is pre-revenue with no commercialized products; revenue generation will depend on successful regulatory approval and subsequent commercialization of its gene therapy candidates. To date, the company has been funded through a combination of private financing rounds and a March 2022 registered direct offering of American Depositary Shares ($26.1M), having previously listed on NASDAQ under the ticker FRLN before delisting and rebranding to Spur Therapeutics. The go-to-market motion is enterprise/field-sales oriented in the long term, advancing candidates through FDA regulatory pathways and targeting rare-disease patients through clinical research, with planned distribution via specialty channels upon approval. The customer base — once commercialized — will center on patients with Gaucher disease type 1 (primary) and Parkinson's disease (secondary), positioning the company in the orphan and large chronic-disease gene therapy segments respectively.

Freeline firmographics

Firmographics
Name
Freeline
Legal name
Spur Therapeutics
Website
https://freeline.life
Company type
Private
Founded year
2015
Operating status
Operating
Headcount range
251–500 employees
Short description
Spur Therapeutics (formerly Freeline) is a clinical-stage UK biotech developing AAV-based single-dose gene therapies, with lead candidate FLT201 in Phase 3 for Gaucher disease type 1 and a pipeline extending into Parkinson's and other chronic conditions. The company is pre-revenue, targeting rare-disease and neurodegenerative patients upon regulatory approval.
Ownership category
akta.pro rank

Freeline industry classification

Industry
Product category
Gene Therapy
NAICS
Research and Development in Biotechnology (except Nanobiotechnology) (541714)
SIC
Services-Commercial Physical & Biological Research (8731)
akta.pro primary industry
AAV Vector Gene Therapy Developers (HLAAACAA)
akta.pro secondary industries
Gene Therapy for Rare/Monogenic Diseases (HLAAACAE), Neurology/CNS Gene Therapies (HLAAACAH), Gene Therapy Regulatory, Pharmacovigilance & Clinical Operations Services (HLAAACAM)

Keywords

  • Gene therapy
  • AAV vectors
  • Rare disease therapeutics
  • Biotechnology pharmaceuticals
  • Clinical development

Where Freeline is headquartered

Location

Headquarters

HQ city
Stevenage
HQ country
United Kingdom
HQ region
Europe

Markets served

Freeline business model

Business model
GTM type
B2B
Offering type
Hardware or Manufacturing
Cost components
Technology or R&D, Personnel, Operations, Marketing or Sales

Revenue model

  1. Gene Therapy Product Commercialization: Pre-revenue clinical-stage biotech. Developing gene therapy candidates (FLT201 for Gaucher disease, Parkinson's programs) that will generate revenue upon FDA approval and commercial launch. Currently funded through registered direct offerings and other corporate activities.

Go-to-market motion1 record

Distribution channels1 record

Marketing channels2 records

Freeline product offering

Product offering

Core offering

Freeline (now Spur Therapeutics) is a clinical-stage biotechnology company developing transformative AAV-based gene therapies for systemic debilitating diseases. Its lead candidate, avigbagene parvec (FLT201), is an investigational AAV gene therapy for Gaucher disease type 1 currently advancing through the GALILEO-3 Phase 3 registrational trial. The company is also building a Parkinson's disease gene therapy program and expanding toward additional widespread conditions.

Product overview

Spur Therapeutics (formerly Freeline Therapeutics) is a clinical-stage biotech developing gene therapies. The company's pipeline consists of avigbagene parvec (FLT201), an AAV gene therapy for Gaucher disease type 1 currently in Phase 3 registrational trials (GALILEO-3), and a Parkinson's Disease program focused on disease-modifying treatments. The company is expanding its gene therapy approach from rare diseases toward more widespread conditions including forms of Parkinson’s and dementia, and certain cardiovascular diseases.

Differentiator

Problem solved

Functional benefit

Products and services

  • avigbagene parvec (FLT201)

Quantifiable outcome

  • Two-year follow-up data demonstrating avigbagene parvec (FLT201) efficacy and impact on bone health markers in adults with Gaucher disease type 1 from GALILEO-1 and GALILEO-2 trials

Companies that use Freeline

Customer profile

Segments2 records

Ideal customer profiles2 records

Freeline technology and API

Technology

Technology focussed Yes

API detail

Has API
No
API docs
API detail

Core technology

AI maturity

App detail

Feature2 records

Freeline partnerships and signals

Strategic signal

Scale indicators3 records

Recent moves6 records

Expansion highlights5 records

Freeline competitors and assessment

Company assessment

Direct peers

  • Passage Bio: Clinical-stage AAV gene therapy company focused on rare monogenic CNS diseases; comparable in scale, modality, and pipeline focus on AAV delivery for rare and neurological indications.
  • BioMarin Pharmaceutical: Commercial-stage AAV gene therapy developer with Roctavian (valoctocogene roxaparvovec) for hemophilia A; directly comparable as a clinical-to-commercial AAV gene therapy company pursuing registrational approvals for rare diseases.
  • uniQure: AAV gene therapy developer with a Phase 3 program (etranacogene dezaparvovec partnered with CSL Behring for hemophilia B); closely comparable as an AAV-focused company advancing through pivotal trials in rare monogenic diseases.
  • REGENXBIO: Pure-play AAV gene therapy platform company with internal pipeline and licensing model; comparable as a technology-platform peer supplying and developing AAV-based therapeutics across rare and CNS indications.
  • Voyager Therapeutics: Clinical-stage gene therapy company developing AAV-based therapies primarily for CNS/neurological disorders including Parkinson's disease; directly comparable as a fellow AAV developer pursuing Parkinson's with disease-modifying ambition.
  • Solid Biosciences: Clinical-stage AAV gene therapy developer focused on Duchenne muscular dystrophy and other rare muscle/CNS disorders; comparable as a clinical-stage AAV pure-play with similar scale and regulatory pathway focus.
  • Lexeo Therapeutics: Clinical-stage AAV gene therapy company with programs in cardiac and CNS rare diseases; comparable as a recent-era AAV developer expanding beyond monogenic rare diseases into broader indications like cardiovascular.
  • Taysha Gene Therapies: Clinical-stage AAV gene therapy company with a CNS-focused pipeline; comparable in modality, clinical stage, and rare/neurological disease focus to Spur Therapeutics.

Broad incumbents

  • Sanofi (Genzyme): Through Genzyme, markets Cerezyme/imiglucerase — the dominant enzyme replacement therapy for Gaucher disease type 1; the established incumbent Spur would need to displace or convert patients from this franchise.

Emerging players

  • Prevail Therapeutics (Eli Lilly): AAV-based gene therapy developer (now part of Eli Lilly) focused on GBA1-linked Parkinson's disease and other CNS/neurodegenerative disorders; directly overlaps with Spur's Parkinson's program targeting disease modification.

Market position

Strengths4 records

Weaknesses4 records

Competitive moat3 records

Key risks6 records

Key highlights6 records

Customer concentration

Freeline social profiles

Digital presence

Freeline financial estimates

Financial estimate

Revenue estimate

Valuation estimate

Freeline leadership team

Management profile

Number of profiles

Profiles7 records

Freeline funding detail

Funding detail

Funding overview

Funding rounds7 records

Investors9 records

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

Freeline M&A and investment

M&A and investment

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Freeline

What does Freeline do?

Freeline (now Spur Therapeutics) is a clinical-stage biotechnology company developing transformative AAV-based gene therapies for systemic debilitating diseases. Its lead candidate, avigbagene parvec (FLT201), is an investigational AAV gene therapy for Gaucher disease type 1 currently advancing through the GALILEO-3 Phase 3 registrational trial. The company is also building a Parkinson's disease gene therapy program and expanding toward additional widespread conditions.

Is Freeline a public or private company?

Freeline is a private company. It is classified as venture growth investor backed and is currently operating.

When was Freeline founded?

Freeline was founded in 2015. It employs 251 to 500 people.

Where is Freeline based?

Freeline is headquartered in Stevenage, United Kingdom, in the Europe region.

How does Freeline make money?

One revenue line is on record: gene Therapy Product Commercialization.

Who are Freeline's main competitors?

Direct peers on record are Passage Bio, BioMarin Pharmaceutical, uniQure, REGENXBIO, Voyager Therapeutics, Solid Biosciences, Lexeo Therapeutics and Taysha Gene Therapies. Sanofi (Genzyme) is listed as a broad incumbent. Prevail Therapeutics (Eli Lilly) is listed as an emerging player.

Does Freeline have an API?

No public API is recorded for Freeline.

What industry is Freeline in?

Freeline's product category is Gene Therapy. Its primary akta.pro industry code is HLAAACAA, AAV Vector Gene Therapy Developers, with a secondary code of HLAAACAE, Gene Therapy for Rare/Monogenic Diseases. Its NAICS code is 541714 and its SIC code is 8731.

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Live signals
GlobeNewswireFreeline Presents Positive New Data from Phase 1/2 Trial of FLT201, Its Novel Gene Therapy Candidate for Gaucher Disease, in Late-Breaking Oral Presentation at ASGCT 27th Annual MeetingFreeline Therapeutics presented new data from its Phase 1/2 GALILEO-1 trial of FLT201, a gene therapy for Gaucher disease, at ASGCT 27th Annual Meeting. The data showed substantial reductions in lyso-Gb1 and early signs of improved bone marrow burden and fatigue in four patients off prior therapies. FLT201 has received RMAT and PRIME designations from the FDA and EMA.BenzingaWhy Is Gene Therapy Player Freeline Therapeutics (FRLN) Stock Gaining Today?London-listed Syncona Ltd has agreed to acquire Freeline Therapeutics Holdings plc (NASDAQ:FRLN) in an all-cash transaction for $6.50 per American Depositary Share, valuing Freeline's entire issued share capital at approximately $28.3 million, representing a 51% premium over the closing price before Syncona's initial proposal was announced on October 18. Syncona is also committing to provide Freeline with up to $15 million in secured convertible debt financing at 12% annual interest, capitalized monthly in arrears, to support operations and the advancement of FLT201, its gene therapy candidate for Gaucher disease, through completion of the transaction expected in Q1 2024. Upon closing, Freeline will become a wholly owned Syncona portfolio company and its ADSs will be delisted from Nasdaq.MarketScreenerADRs Advance; Freeline Therapeutics Holdings Climbs 30%International stocks trading in New York closed higher on Friday, with the S&P/BNY Mellon index of American depositary receipts gaining 0.6%. Freeline Therapeutics Holdings PLC led gains with a 30% increase, while Autolus Therapeutics Ltd. and Oatly Group AB also posted significant surges. Conversely, Puyi experienced the largest decline, tumbling almost 18%, followed by drops in XTL Biopharmaceuticals and Fresh2 Group shares.BenzingaWhy Is Gene Therapy Player Freeline Therapeutics Stock Trading Higher Today?Freeline Therapeutics Holdings plc reported initial data from its ongoing Phase 1/2 GALILEO-1 trial of FLT201, an adeno-associated virus gene therapy candidate for Gaucher disease, showing that two patients treated with a single infusion achieved several hundred-fold increases in GCase enzyme activity. Both patients successfully discontinued prior therapies with no serious adverse events, no infusion reactions, and no liver enzyme elevations reported as of the data cutoff. The positive preliminary results drove Freeline stock up 5.05% to $3.95 per share.GlobeNewswirePress Release Distribution and ManagementFreeline Therapeutics announced the completion of dosing in the first cohort of its Phase 1/2 GALILEO-1 trial for FLT201, a gene therapy candidate for Gaucher disease. The company expects to report initial clinical data from this trial in the third quarter of 2023.PR NewswireThinking about buying stock in ALX Oncology Holdings, RedHill Biopharma, Freeline Therapeutics Holdings, Terawulf, or I-Mab?InvestorsObserver issued critical PriceWatch Alerts for stocks in ALX Oncology Holdings, RedHill Biopharma, Freeline Therapeutics Holdings, Terawulf, and I-Mab. The alerts are generated using a proprietary scoring methodology that evaluates short-term technical, long-term technical, and fundamental factors to determine investment suitability.BenzingaFreeline Therapeutics Announces Second Round Of Layoffs, Shelves Fabry Disease ProgramFreeline Therapeutics Holdings plc announced a second round of layoffs, cutting its workforce by nearly 30% to approximately 65 employees, and is pausing development of its FLT190 program for Fabry disease to concentrate resources on FLT201, a gene therapy candidate for Gaucher disease type 1 currently in a Phase 1/2 trial. The company is actively screening patients for dosing in its GALILEO-1 trial and now expects to report initial data in Q3 2023, having previously stopped investment in its hemophilia program FLT180a without a partner. With unrestricted cash of $47.3 million, Freeline expects its runway to extend into Q2 2024.BioPharma DiveFreeline cuts back as it continues search for gene therapy partnerFreeline Therapeutics is selling its German unit to Ascend Gene and Cell Therapies for $25 million while also halting investment in a hemophilia treatment and laying off approximately 30 employees. The company is narrowing its focus to two product candidates, FLT201 and FLT190, which are expected to provide greater value for shareholders. This strategic shift comes as Freeline has yet to advance its hemophilia therapy into Phase 3 testing and aims to preserve cash for ongoing operations into 2024.BenzingaFreeline Therapeutics Stops Further Development On Hemophilia Program, Cuts WorkforceFreeline Therapeutics Holdings plc (NASDAQ:FRLN) has decided to halt development of FLT180a for hemophilia without a partner and is reducing its workforce by approximately 30 employees, refocusing resources on its Gaucher disease and Fabry disease programs. The company announced positive updated data from its MARVEL-1 Phase 1/2 trial showing sustained α-Gal A levels for up to three years in one patient and one year in another, with no long-term cardiac sequelae observed. Freeline has agreed to sell its CMC-focused German subsidiary to Ascend Gene and Cell Therapies Ltd for $25 million, which combined with its $65.8 million cash position will fund operations into 2024.BenzingaThis Penny Stock Touts Encouraging Long-Term Data For Hemophilia Gene TherapySmall biotech Freeline Therapeutics Holdings plc announced that the New England Journal of Medicine published positive long-term follow-up data from its Phase 1/2 B-AMAZE trial of hemophilia B gene therapy candidate FLT180a, with nine of 10 patients maintaining factor IX activity at a median follow-up of 27.2 months and one patient showing response at 42.4 months. The study also noted one patient experienced a severe adverse event of arteriovenous fistula thrombosis. The company expects enrollment in the Phase 1/2 B-LIEVE dose confirmation trial to conclude by end of Q3, enabling pivotal Phase 3 start-up activities in the first half of 2023.