Fractyl Health, Inc. (NASDAQ:GUTS) Q1 2024 Earnings Conference Call May 13, 2024 4:30 PM ET Company Participants Stephen Jasper - Gilmartin Group Harith Rajagopalan - Co-founder and CEO Lisa Davidson - CFO Timothy Kieffer - Chief Scientific Officer Adrian Kimber - Chief Commercial Officer Conference Call Participants Michael DiFiore - Evercore ISI Michael Ulz - Morgan Stanley Operator Good afternoon, and welcome to Fractyl Health's First Quarter Financial Results and Business Updates Call. As a reminder, th ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ___________________ to ___________________ Commission File Number: 001-41942 Fractyl Health, Inc. (Exact Name of Registrant as Specified in its Charter) (State ...

Initiation of Remain-1 pivotal study for weight maintenance in patients with obesity after discontinuation of GLP-1 based drugs expected in the second half of 2024 Topline data from Revitalize-1 pivotal study in patients with inadequately controlled T2D anticipated in the fourth quarter 2024 Update from real-world Germany registry study of Revita in patients with T2D at DDG Annual Meeting Exhibit 99.1 Fractyl Health Reports First Quarter 2024 Financial Results and Provides Business Updates Appointed Adrian ...

Part I [Business](index=8&type=section&id=Item%201.%20Business) Fractyl Health develops disease-modifying therapies for type 2 diabetes and obesity, with lead product Revita and gene therapy platform Rejuva - Fractyl Health is a metabolic therapeutics company developing disease-modifying therapies for **type 2 diabetes (T2D)** and **obesity** by targeting organ-level root causes[30](index=30&type=chunk) - The lead product, **Revita DMR System**, is an outpatient procedural therapy for duodenal dysfunction, with **CE Mark** in Europe and a pivotal U.S. study, **Revitalize-1**, underway[31](index=31&type=chunk)[32](index=32&type=chunk) - The company is developing **Rejuva**, a novel pancreatic gene therapy platform, with first candidate **RJVA-001** for T2D, targeting a first-in-human study in **H1 2025**[34](index=34&type=chunk) Development Pipeline and Anticipated Milestones | Product | Indication | Status | Anticipated Milestones | | :--- | :--- | :--- | :--- | | **Revita** | Weight Maintenance (Remain-1) | Pivotal (2024) | IDE approved Q1 2024; Study initiation H2 2024 | | | Insulin-Treated T2D (Revitalize-1) | Pivotal | Complete enrollment H1 2024; Topline data Q4 2024 | | | CE Mark (Germany Registry) | Launch | Quarterly open label data updates ongoing | | **Rejuva** | T2D (RJVA-001) | Preclinical | Complete IND-enabling studies H2 2024; Initiate FIH study H1 2025 | | | Obesity | Preclinical | Candidate nomination H2 2024 | [Commercialization Strategy](index=62&type=section&id=Item%201.%20Business.Commercialization%20Strategy) Fractyl Health is piloting Revita in Germany and plans a targeted U.S. 'hub-and-spoke' launch, leveraging existing infrastructure for Rejuva - The company initiated a limited commercial pilot for **Revita** in **Germany**, holding a **CE Mark** and **NUB reimbursement authorization**[218](index=218&type=chunk) - In the U.S., **Revita** received **Breakthrough Device designation**, with a **PMA submission** planned for **H1 2025** after the **Revitalize-1** study[219](index=219&type=chunk) - The U.S. go-to-market strategy is a targeted **'hub-and-spoke' model**, focusing on **centers of excellence** and specialized medical professionals[222](index=222&type=chunk) - The **Rejuva platform** is designed to leverage **Revita's commercial footprint**, including its console system and physician base, for rapid commercialization[226](index=226&type=chunk) [Intellectual Property](index=64&type=section&id=Item%201.%20Business.Intellectual%20Property) Fractyl Health protects its technology through 23 issued U.S. and 71 issued foreign patents, 41 registered trademarks, and trade secrets Owned Patent Portfolio Summary (as of March 15, 2024) | Category | U.S. Issued | U.S. Pending | Foreign Issued | Foreign Pending | | :--- | :--- | :--- | :--- | :--- | | **Total Portfolio** | 23 | 25 (+13 provisional) | 71 | 26 | | **Revita-Specific** | 18 | 17 (+3 provisional) | 61 | 19 | | **Rejuva-Specific** | 0 | 1 (+9 provisional) | 0 | 2 | - Owned issued U.S. patents are expected to expire between **January 2032** and **May 2036**, with foreign patents expiring between **January 2032** and **September 2038**[233](index=233&type=chunk) - The company owns **41 registered trademarks** and **10 pending applications** for brands like **FRACTYL**, **REVITA**, and **REJUVA**[239](index=239&type=chunk) - The company also relies on **trade secrets**, **know-how**, and **confidentiality agreements** to protect proprietary information, especially for software[239](index=239&type=chunk)[240](index=240&type=chunk) [Government Regulation](index=67&type=section&id=Item%201.%20Business.Government%20Regulation) Fractyl Health's products are subject to extensive regulation by the FDA (PMA for Revita, BLA for Rejuva) and EU (CE Mark), along with various healthcare laws - In the U.S., **Revita** is regulated as a **Class III medical device**, requiring **Premarket Approval (PMA)** from the **FDA**[254](index=254&type=chunk) - The **Rejuva gene therapy candidates** are expected to be regulated as **combination biologic/device products**, likely requiring a single **Biologics License Application (BLA)**[270](index=270&type=chunk)[272](index=272&type=chunk) - In the European Union, medical devices must comply with the **Medical Devices Regulation (MDR)**, requiring a **CE Mark** for market access[310](index=310&type=chunk)[312](index=312&type=chunk)[314](index=314&type=chunk) - The company is subject to numerous healthcare laws, including the federal **Anti-Kickback Statute**, **False Claims Act**, and **Physician Payments Sunshine Act**[357](index=357&type=chunk)[361](index=361&type=chunk) [Risk Factors](index=109&type=section&id=Item%201A.%20Risk%20Factors) The company faces significant financial, regulatory, clinical, manufacturing, commercial, and intellectual property risks, alongside intense competition and stringent healthcare regulations - **Financial Risks:** The company has a history of significant net losses, reaching **$77.1 million in 2023**, and will require substantial additional capital to fund operations[393](index=393&type=chunk)[397](index=397&type=chunk) - **Regulatory & Clinical Risks:** The business heavily depends on **Revita's success**, facing lengthy and unpredictable regulatory approval processes and uncertain clinical trial outcomes[417](index=417&type=chunk)[432](index=432&type=chunk)[492](index=492&type=chunk) - **Manufacturing & Supply Risks:** Reliance on **third-party** and **sole-source suppliers** for **Revita** and **Rejuva** components increases supply disruption risks[555](index=555&type=chunk)[563](index=563&type=chunk) - **Commercial & Market Risks:** The company faces significant competition and uncertainty in gaining market acceptance and securing adequate reimbursement from payors[520](index=520&type=chunk)[457](index=457&type=chunk) - **Intellectual Property Risks:** Success depends on obtaining, maintaining, and protecting intellectual property, as patents may be challenged, invalidated, or circumvented[601](index=601&type=chunk)[602](index=602&type=chunk) [Unresolved Staff Comments](index=204&type=section&id=Item%201B.%20Unresolved%20Staff%20Comments) The company reports no unresolved staff comments - None[710](index=710&type=chunk) [Cybersecurity](index=204&type=section&id=Item%201C.%20Cybersecurity) The company implements a NIST-based cybersecurity risk management program overseen by the Audit Committee, with no material threats identified to date - The company developed a cybersecurity risk management program guided by the **National Institute of Standards and Technology Cybersecurity Framework (NIST CSF)**[712](index=712&type=chunk) - Oversight is provided by the **Audit Committee** of the Board of Directors, reviewing controls, security systems, and contingency plans[715](index=715&type=chunk) - Day-to-day cybersecurity risk management is handled by a management team, including the **Director of Information Technology** and a **Security Officer**[719](index=719&type=chunk) - No identified cybersecurity threats have materially affected or are reasonably likely to materially affect the company's operations, business strategy, or financial condition[714](index=714&type=chunk) [Properties](index=206&type=section&id=Item%202.%20Properties) The company's headquarters in Burlington, Massachusetts, comprises approximately 78,000 square feet of office and laboratory space under a lease expiring in June 2034 - The company's corporate headquarters in **Burlington, Massachusetts**, leases approximately **78,000 square feet** of office and laboratory space[721](index=721&type=chunk) - The lease for the Burlington facility expires in **June 2034**[721](index=721&type=chunk) [Legal Proceedings](index=206&type=section&id=Item%203.%20Legal%20Proceedings) The company is not subject to any material legal proceedings - The company is not subject to any material legal proceedings[722](index=722&type=chunk) [Mine Safety Disclosures](index=206&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company - Not Applicable[723](index=723&type=chunk) Part II [Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities](index=207&type=section&id=Item%205.%20Market%20for%20Registrant%27s%20Common%20Equity%2C%20Related%20Stockholder%20Matters%20and%20Issuer%20Purchases%20of%20Equity%20Securities) Fractyl Health's common stock began trading on Nasdaq under 'GUTS' in February 2024, raising **$100.3 million** net from its IPO, with no plans for dividends - The company's common stock began trading on the **Nasdaq Global Market** under symbol **'GUTS'** on **February 2, 2024**, with approximately **101 holders of record** as of **March 15, 2024**[726](index=726&type=chunk)[727](index=727&type=chunk) - The company has never paid cash dividends and intends to retain earnings for business development[728](index=728&type=chunk) - The **IPO** on **February 6, 2024**, raised approximately **$98.9 million** in net proceeds, with an additional **$1.4 million** from underwriters' option in **March 2024**[734](index=734&type=chunk)[735](index=735&type=chunk) - In **2023**, the company issued unregistered securities, including **warrants to lenders** and **1,833,574 stock options** and **604,509 RSUs** to employees and directors[729](index=729&type=chunk)[730](index=730&type=chunk)[732](index=732&type=chunk) [Reserved](index=208&type=section&id=Item%206.%20%5BReserved%5D) This item is reserved [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=209&type=section&id=Item%207.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) The company's net loss increased to **$77.1 million** in **2023** due to higher R&D and negative fair value changes, with **$100.3 million** IPO proceeds expected to fund operations through **2025** Consolidated Results of Operations (in thousands) | | Year Ended December 31, | Change | | | :--- | :--- | :--- | :--- | :--- | | | **2023** | **2022** | **Amount** | **%** | | Revenue | $120 | $— | $120 | 100.0% | | Loss from operations | $(50,836) | $(49,385) | $(1,451) | 2.9% | | Other income (expense), net | $(26,255) | $2,932 | $(29,187) | (995.5%) | | **Net loss** | **$(77,091)** | **$(46,453)** | **$(30,638)** | **66.0%** | - Research and development expenses increased by **$3.7 million (10.7%)** in **2023**, driven by higher personnel, stock-based compensation, medical affairs, clinical study, and facilities costs[785](index=785&type=chunk)[788](index=788&type=chunk) - Selling, general and administrative expenses decreased by **$2.2 million (14.6%)** in **2023**, mainly due to a **$2.7 million IPO cost write-off** in **2022** not recurring[789](index=789&type=chunk) - Other income (expense), net, swung negatively by **$29.2 million**, primarily due to a **$19.4 million loss** from convertible notes and a **$6.8 million loss** from warrant liabilities fair value changes[791](index=791&type=chunk)[792](index=792&type=chunk)[793](index=793&type=chunk) - As of **December 31, 2023**, the company had **$33.2 million** in cash, with **$100.3 million** net proceeds from its **February/March 2024 IPO** expected to fund operations through **2025**[796](index=796&type=chunk)[798](index=798&type=chunk)[799](index=799&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=231&type=section&id=Item%207A.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company faces interest rate, credit, foreign currency, and inflation risks, though none have had a material impact to date - **Interest Rate Risk:** The company's **2023 Notes** have a floating interest rate, but a **10% change** in the prime rate is not expected to be material[839](index=839&type=chunk) - **Credit Risk:** Cash and cash equivalents are held at a few financial institutions, with deposits exceeding federally insured limits[840](index=840&type=chunk) - **Foreign Currency Risk:** Risk is currently low as business is conducted almost entirely in **U.S. dollars**[841](index=841&type=chunk) - **Inflation Risk:** While not material to date, high future inflation could significantly increase operating expenses[842](index=842&type=chunk) [Financial Statements and Supplementary Data](index=231&type=section&id=Item%208.%20Financial%20Statements%20and%20Supplementary%20Data) This section refers to the company's audited consolidated financial statements and related notes, appended starting on page F-1 - The company's audited consolidated financial statements for **December 31, 2023** and **2022**, and the independent auditor's report, are included in **Part IV, Item 15**[843](index=843&type=chunk)[943](index=943&type=chunk) [Changes in and Disagreements with Accountants on Accounting and Financial Disclosure](index=231&type=section&id=Item%209.%20Changes%20in%20and%20Disagreements%20with%20Accountants%20on%20Accounting%20and%20Financial%20Disclosure) The company reports no changes in or disagreements with its accountants on accounting and financial disclosure - None[844](index=844&type=chunk) [Controls and Procedures](index=231&type=section&id=Item%209A.%20Controls%20and%20Procedures) Management concluded disclosure controls were effective as of **December 31, 2023**, with no material changes to internal controls identified in Q4 2023 - Management concluded that as of **December 31, 2023**, the company's disclosure controls and procedures were effective at a reasonable assurance level[846](index=846&type=chunk) - As a newly public company, this Annual Report does not include a management assessment or auditor attestation on internal control over financial reporting[847](index=847&type=chunk) - No changes in internal control over financial reporting during **Q4 2023** have materially affected or are reasonably likely to materially affect internal controls[848](index=848&type=chunk) [Other Information](index=232&type=section&id=Item%209B.%20Other%20Information) No director or officer adopted or terminated a Rule 10b5-1 or non-Rule 10b5-1 trading arrangement during Q4 2023 - During the three months ended **December 31, 2023**, no director or officer adopted or terminated a **Rule 10b5-1** or non-**Rule 10b5-1** trading arrangement[850](index=850&type=chunk) [Disclosure Regarding Foreign Jurisdictions that Prevent Inspections](index=232&type=section&id=Item%209C.%20Disclosure%20Regarding%20Foreign%20Jurisdictions%20that%20Prevent%20Inspections) This item is not applicable to the company - Not applicable[851](index=851&type=chunk) Part III [Directors, Executive Officers and Corporate Governance](index=233&type=section&id=Item%2010.%20Directors%2C%20Executive%20Officers%20and%20Corporate%20Governance) This section details the company's executive officers and directors, including CEO Harith Rajagopalan, and outlines its corporate governance, including a code of ethics and an independent audit committee - The company's leadership includes co-founders **Harith Rajagopalan, M.D., Ph.D. (CEO)** and **Jay D. Caplan (President & CPO)**[854](index=854&type=chunk)[855](index=855&type=chunk) - The Board of Directors, chaired by **Allan R. Will**, includes members with diverse backgrounds such as **Senator William W. Bradley**[862](index=862&type=chunk)[868](index=868&type=chunk)[869](index=869&type=chunk)[870](index=870&type=chunk) - A **code of business conduct and ethics** has been adopted, applying to all directors, officers, and employees[873](index=873&type=chunk) - The audit committee consists of **Kelly Barnes (Chair)**, **Marc Elia**, and **Allan R. Will**, with **Ms. Barnes** designated as the **audit committee financial expert**[874](index=874&type=chunk) [Executive Compensation](index=238&type=section&id=Item%2011.%20Executive%20Compensation) In **2023**, named executive officers received significant compensation, largely in equity, with new employment agreements and a non-employee director compensation program adopted post-IPO 2023 Summary Compensation | Name | Position | Total Compensation ($) | Salary ($) | Stock Awards ($) | Option Awards ($) | Non-Equity Incentive ($) | | :--- | :--- | :--- | :--- | :--- | :--- | :--- | | Harith Rajagopalan | CEO | 3,561,774 | 550,000 | 2,430,014 | 267,990 | 313,500 | | Timothy Kieffer | CSO | 3,462,288 | 92,438 | — | 3,321,650 | 23,200 | | Jay D. Caplan | President & CPO | 2,873,373 | 400,000 | 2,097,678 | 220,507 | 154,000 | - Annual cash bonuses for **2023** were based on achieving corporate goals, including **Revitalize-1** and **Rejuva** progress, and individual performance[880](index=880&type=chunk) - In **2023**, the company granted **stock options** and **dual-vesting RSUs** to named executive officers as long-term incentive compensation[881](index=881&type=chunk)[884](index=884&type=chunk) - Effective upon the **IPO**, base salaries increased for **Dr. Rajagopalan ($610,000)**, **Mr. Caplan ($475,000)**, and **Dr. Kieffer ($225,000)**, with new performance-based options granted[894](index=894&type=chunk)[895](index=895&type=chunk) - A new non-employee director compensation program was adopted post-IPO, including annual cash retainers and initial and annual stock option grants[907](index=907&type=chunk)[909](index=909&type=chunk) [Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters](index=249&type=section&id=Item%2012.%20Security%20Ownership%20of%20Certain%20Beneficial%20Owners%20and%20Management%20and%20Related%20Stockholder%20Matters) As of **March 15, 2024**, executive officers and directors beneficially owned **25.3%** of common stock, with several institutional investors holding over **5%** - As of **March 15, 2024**, all current executive officers and directors as a group beneficially owned **13,089,394 shares**, representing **25.3%** of outstanding common stock[917](index=917&type=chunk) Beneficial Ownership of 5% or Greater Stockholders (as of March 15, 2024) | Beneficial Owner | Shares Beneficially Owned | Percentage | | :--- | :--- | :--- | | Entities affiliated with Mithril | 6,078,868 | 12.7% | | CVF, LLC | 5,544,669 | 11.4% | | Entities affiliated with General Catalyst | 4,884,186 | 10.2% | | Entities affiliated with Bessemer Venture Partners | 4,770,901 | 10.0% | | Entities affiliated with Domain Associates, L.L.C. | 4,003,135 | 8.4% | | Entities affiliated with Maverick Capital | 3,458,799 | 7.1% | | Harith Rajagopalan, M.D., Ph.D. | 2,912,670 | 5.8% | - Ownership percentages are based on **47,878,269 shares** of common stock outstanding as of **March 15, 2024**[915](index=915&type=chunk) [Certain Relationships and Related Transactions, and Director Independence](index=253&type=section&id=Item%2013.%20Certain%20Relationships%20and%20Related%20Transactions%2C%20and%20Director%20Independence) This section details related party transactions, including warrant issuances and pre-IPO agreements that terminated, and confirms the board's majority director independence - In **July 2023**, the company issued warrants to purchase common stock to lenders of its **2022 Convertible Notes**, including **5% stockholder CVF, LLC**[923](index=923&type=chunk)[924](index=924&type=chunk) - Prior to the **IPO**, the company had **Investors' Rights**, **Voting**, and **Right of First Refusal and Co-Sale Agreements** with preferred stockholders, which terminated upon the **IPO**[925](index=925&type=chunk)[926](index=926&type=chunk)[927](index=927&type=chunk) - The company has entered into **employment agreements** with executive officers and **indemnification agreements** with all directors and officers[930](index=930&type=chunk)[931](index=931&type=chunk) - The Board has adopted a policy for related person transactions and determined that **Kelly Barnes**, **William W. Bradley**, **Samuel Conaway**, **Marc Elia**, **Clive Meanwell**, **Ajay Royan**, **Amy W. Schulman**, and **Allan R. Will** are independent directors[932](index=932&type=chunk)[933](index=933&type=chunk) [Principal Accountant Fees and Services](index=255&type=section&id=Item%2014.%20Principal%20Accountant%20Fees%20and%20Services) This section details **Ernst & Young LLP** fees for **2023 ($1.22 million)** and **2022 ($0.89 million)**, primarily for audit services, with an audit committee pre-approval policy Accountant Fees (in thousands) | Fee Category | 2023 | 2022 | | :--- | :--- | :--- | | Audit Fees | $1,187.5 | $772.9 | | Audit-Related Fees | $— | $— | | Tax Fees | $31.6 | $112.4 | | All Other Fees | $— | $— | | **Total** | **$1,219.1** | **$885.3** | - Audit fees consist of fees for the audit of consolidated financial statements and services related to the **IPO**[936](index=936&type=chunk) - The audit committee has a pre-approval policy for all services provided by **Ernst & Young LLP**[940](index=940&type=chunk) Part IV [Exhibits and Financial Statement Schedules](index=258&type=section&id=Item%2015.%20Exhibits%20and%20Financial%20Statement%20Schedules) This section lists the financial statements and exhibits filed with the Annual Report on Form 10-K, including corporate governance documents and material contracts - This item provides an index to the **Consolidated Financial Statements**, which begin on page **F-1** of the report[942](index=942&type=chunk)[943](index=943&type=chunk) - A list of exhibits filed includes corporate governance documents, material contracts, and required certifications[945](index=945&type=chunk)[946](index=946&type=chunk)[948](index=948&type=chunk) [Form 10-K Summary](index=261&type=section&id=Item%2016.%20Form%2010-K%20Summary) The company reports no Form 10-K summary - None[951](index=951&type=chunk) Financial Statements [Consolidated Balance Sheets](index=265&type=section&id=Consolidated%20Balance%20Sheets) As of **December 31, 2023**, total assets increased to **$76.2 million**, liabilities to **$113.9 million**, and cash decreased to **$33.2 million**, with an accumulated deficit of **$346.6 million** Consolidated Balance Sheet Data (in thousands) | | Dec 31, 2023 | Dec 31, 2022 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $33,209 | $49,269 | | Total current assets | $35,648 | $51,629 | | **Total assets** | **$76,212** | **$60,956** | | **Liabilities & Stockholders' Deficit** | | | | Total current liabilities | $11,188 | $7,311 | | Notes payable, long-term | $55,152 | $17,760 | | Lease liabilities, long-term | $28,508 | $465 | | Warrant liabilities, long-term | $19,096 | $407 | | **Total liabilities** | **$113,944** | **$25,945** | | Accumulated deficit | $(346,616) | $(269,525) | | **Total stockholders' deficit** | **$(325,062)** | **$(252,319)** | [Consolidated Statements of Operations and Comprehensive Loss](index=266&type=section&id=Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) For **2023**, the company reported a net loss of **$77.1 million**, up from **$46.5 million** in **2022**, driven by negative changes in other income/expense and increased R&D costs Consolidated Statement of Operations Data (in thousands) | | Year Ended Dec 31, 2023 | Year Ended Dec 31, 2022 | | :--- | :--- | :--- | | Revenue | $120 | $— | | Gross profit | $43 | $— | | Research and development | $38,038 | $34,354 | | Selling, general and administrative | $12,841 | $15,031 | | **Loss from operations** | **$(50,836)** | **$(49,385)** | | Total other income (expense), net | $(26,255) | $2,932 | | **Net loss and comprehensive loss** | **$(77,091)** | **$(46,453)** | | Net loss per share, basic and diluted | $(45.29) | $(31.97) | [Consolidated Statements of Cash Flows](index=268&type=section&id=Consolidated%20Statements%20of%20Cash%20Flows) In **2023**, net cash used in operations was **$42.8 million**, while financing activities provided **$27.4 million**, resulting in a **$15.7 million** net decrease in cash Consolidated Statement of Cash Flows Data (in thousands) | | Year Ended Dec 31, 2023 | Year Ended Dec 31, 2022 | | :--- | :--- | :--- | | Net cash used in operating activities | $(42,823) | $(46,243) | | Net cash used in investing activities | $(359) | $(56) | | Net cash provided by financing activities | $27,437 | $4,350 | | **Net decrease in cash, cash equivalents and restricted cash** | **$(15,745)** | **$(41,949)** | - The **$42.8 million** cash used in operations in **2023** was driven by a **$77.1 million** net loss, offset by **$31.3 million** in non-cash charges, including fair value losses on notes payable and warrant liabilities[827](index=827&type=chunk) - Financing activities in **2023** provided **$27.4 million**, primarily from **$28.4 million** in net proceeds from the issuance of the **2023 Notes**[831](index=831&type=chunk)

Announced nomination of RJVA-001 as first clinical candidate in the Rejuva® GLP-1 gene therapy platform; completion of IND- enabling studies expected in second half of 2024 Completed initial public of ering of common stock raising $110 million in gross proceeds; cash on hand expected to fund operations through 2025 BURLINGTON, MA, April 1, 2024 (GLOBENEWSWIRE) – Fractyl Health (Nasdaq: GUTS), a metabolic therapeutics company focused on pioneering new approaches for the treatment of type 2 diabetes (T2D) and ...