FRACTYL HEALTH, INC.

Listed Company

GUTSCIK 0001572616NasdaqNon-AcceleratedSmaller ReportingEmerging GrowthSurgical & Medical Instruments & ApparatusDelawareFY ends Dec 31

Period

FY 2025

Revenue

—

Net Income

$-140.95M

Total Assets

$121.40M

Equity

$9.46M

Shares Out

158.65M

Op. Cash Flow

$-90.33M

Business

FRACTYL HEALTH, INC. is a metabolic therapeutics company developing disease‑modifying treatments for obesity and type 2 diabetes by targeting organ‑level dysfunction. Its main product candidates are the Revita DMR System, an investigational outpatient endoscopic hydrothermal ablation procedure for duodenal mucosal renewal, and Rejuva, a locally administered AAV‑delivered pancreatic gene therapy platform (e.g., RJVA‑001, RJVA‑002). The company’s operations are organized around clinical development programs, procedural device commercialization and a gene therapy platform. It conducts clinical studies and commercial pilots across the United States, Europe and select international sites, using outpatient endoscopy and clinical trial networks for distribution and physician adoption.

Summary from filing dated 2025-03-03

Financials

Consolidated Statement of Income

Year Ended · In millions, except per-share amounts

Concept	FY 2025 2025-12-31	FY 2024 2024-12-31	FY 2023 2023-12-31
Revenue	0	93,000	120,000
Cost of goods sold	0	50,000	77,000
Gross Profit	—	43,000	43,000
Research and development	75	70	38
Selling, general and administrative	22	23	13
Total operating expenses	97	94	51
Loss from operations	−97	−94	−51
Interest income, net	2	4	1
Change in fair value of notes payable	−5	3	−21
Change in fair value of warrant liabilities	−41	18	−7
Other expense, net	−53,000	−47,000	−24,000
Total other income (expense), net	−44	25	−26
Net loss and comprehensive loss	−141	−69	−77
Accretion of dividends on convertible preferred stock	—	−2	−17
Net loss attributable to common stockholders	−141	−70	−94
Net loss per share attributable to common stockholders, basic	−1.86	−1.62	−45.29
Net loss per share attributable to common stockholders, diluted	−1.86	−1.62	−45.29
Weighted-average number of common shares outstanding, basic	76	44	2
Weighted-average number of common shares outstanding, diluted	76	44	2

Consolidated Balance Sheet

As of · In millions, except per-share amounts

Concept	FY 2025 2025-12-31	FY 2024 2024-12-31	FY 2023 2023-12-31	FY 2022 2022-12-31
Cash and cash equivalents	82	67	33	—
Inventory	—	73,000	73,000	—
Prepaid expenses and other current assets	6	4	2	—
Total current assets	88	72	36	—
Restricted cash, long-term	4	4	4	—
Property and equipment, net	2	3	490,000	—
Right-of-use lease assets, operating	27	28	30	—
Other long-term assets	337,000	666,000	6	—
Total assets	121	108	76	—
Accounts payable	2	3	553,000	—
Accrued expenses and other current liabilities	12	12	7	—
Operating lease liabilities, current	5	5	3	—
Total current liabilities	18	20	11	—
Notes payable, long-term	31	30	55	—
Operating lease liabilities, long-term	26	27	29	—
Warrant liabilities, long-term	36	1	19	—
Other long-term liabilities	663,000	998,000	—	—
Total liabilities	112	80	114	—
Preferred stock, $0.00001 par value; 10,000,000 shares authorized at December 31, 2025 and 2024; no shares issued and outstanding at December 31, 2025 and 2024	0	0	0	—
Common stock, $0.00001 par value; 300,000,000 shares authorized at December 31, 2025 and 2024; 153,372,044 and 48,755,451 shares issued and outstanding at December 31, 2025 and 2024, respectively	1,000	0	0	—
Additional paid-in capital	566	444	22	—
Accumulated deficit	−556	−415	−347	—
Total stockholders' equity	9	28	−325	−252
Total liabilities and stockholders' equity	121	108	76	—

Consolidated Statement of Cash Flows

Year Ended · In millions, except per-share amounts

Concept	FY 2025 2025-12-31	FY 2024 2024-12-31	FY 2023 2023-12-31
Net loss	−141	−69	−77
Depreciation	1	700,000	286,000
Non-cash interest expense	296,000	357,000	—
Non-cash operating lease expense	2	2	—
Stock-based compensation expense	7	14	4
Change in fair value of notes payable, non-cash	424,000	−6	20
Accounts receivable	—	22,000	−22,000
Inventory	73,000	—	−73,000
Prepaid expenses and other current assets	2	−2	331,000
Accounts payable	−2	3	−427,000
Accrued expenses and other current liabilities	414,000	6	543,000
Operating lease liabilities	−1	1	563,000
Other long-term assets and liabilities	−186,000	2	74,000
Net cash used in operating activities	−90	−66	−43
Purchases of property and equipment	−557,000	−2	−359,000
Net cash used in investing activities	−557,000	−2	−359,000
Proceeds from initial public offering, net of underwriting discounts and commissions	—	104	—
Payments related to initial public offering costs	—	−3	−563,000
Issuance of common stock in connection with at-the-market offering, net of underwriting commissions and offering costs	7	—	—
Issuance of common stock and warrants in August 2025 public offering, net of underwriting commissions and offering costs	23	—	—
Issuance of common stock in September 2025 public offering, net of underwriting commissions and offering costs	56	—	—
Proceeds from issuance of common stock under share purchase agreement	20,000	—	—
Exercises of common stock warrants	20	—	—
Exercises of common stock options	280,000	572,000	52,000
Principal payments on finance lease obligations	−457,000	−187,000	−9,000
Net cash provided by financing activities	105	101	27
Net increase in cash, cash equivalents and restricted cash	14	34	−16
Interest paid	4	3	762,000
Payment for operating leases within operating activities	5	3	2
Fair value of warrant liabilities recognized in connection with August 2025 public offering	19	—	3
Reclassification of warrant liabilities into equity upon exercises	25	—	—
Conversion of convertible preferred stock into common stock upon initial public offering	—	287	—
Conversion of 2022 Convertible Notes into common stock upon initial public offering	—	19	—
Reclassification of warrant liability to equity upon initial public offering	—	425,000	—
Finance lease right-of-use asset obtained in exchange for lease liability	—	1	—
Reclassification of deferred offering costs to additional paid-in capital	—	3	—

Filings

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