Executive Summary

Q2 2024 focused on clinical/regulatory momentum: FDA granted Breakthrough Device designation for Revita in weight maintenance post-GLP‑1 discontinuation, REMAIN‑1 pivotal study was initiated, and German real‑world registry 12‑month data showed durable weight loss and glycemic improvement .
Operating investment scaled to pipeline execution (R&D $16.8M; SG&A $6.2M), while net loss improved YoY to $(17.2)M (from $(30.2)M) on fair value changes and higher interest income; cash and equivalents were $102.4M with runway into 4Q25 .
REVITALIZE‑1 topline timing was pushed from 4Q24 (prior view) to mid‑2025, while REMAIN‑1 timelines were accelerated with open‑label readouts expected in 4Q24 and a mid‑point analysis in 2Q25 .
Management highlighted an “urgent need” for durable weight maintenance after GLP‑1 discontinuation and framed 2H24–2025 as a “transformational period” with multiple data catalysts across Revita and Rejuva .
Street consensus (S&P Global) for Q2 2024 EPS and revenue was unavailable at time of analysis due to a temporary data limit; therefore, beat/miss cannot be assessed this quarter (S&P Global consensus unavailable).

What Went Well and What Went Wrong

What Went Well
- Breakthrough Device designation for Revita in weight maintenance following GLP‑1 discontinuation, enabling priority FDA review and potentially earlier CMS reimbursement decisions .
- Initiation of REMAIN‑1 pivotal study; open‑label REVEAL‑1 data expected in 4Q24; mid‑point analysis in 2Q25, adding near‑term and mid‑term catalysts .
- Real‑world German registry 12‑month outcomes (n=11 completers): median weight down from 111 kg to 97 kg (~13% TBWL) and median HbA1c down from 9.6% to 7.2%; medications stable or decreased in 10/11; no procedure‑related adverse safety events reported .
- CEO: “We believe the recent FDA Breakthrough Device designation for Revita underscores our differentiated approach… This quarter we were also pleased to share new preclinical data showing that our Rejuva GLP‑1 pancreatic gene therapy platform can durably improve body composition and blood sugar compared to semaglutide…” .
What Went Wrong
- REVITALIZE‑1 topline timing shifted from 4Q24 (prior guidance) to mid‑2025, extending the path to pivotal readout for T2D .
- Operating expenses stepped up materially YoY with R&D $16.8M (vs $9.1M) and SG&A $6.2M (vs $2.8M), reflecting ramp in clinical and public‑company costs .
- Commercial revenue remains de minimis (pilot in Germany): Q2 revenue $43K; business remains dependent on clinical/regulatory milestones rather than near‑term sales .

Financial Results

P&L summary (USD thousands)

Metric (USD $000s)	Q4 2023	Q1 2024	Q2 2024
Revenue	$7	$33	$43
Cost of Goods Sold	$2	$19	$24
Gross Profit	$5	$14	$19
Gross Margin %	71.4% (calc. from $5/$7)	42.4% (calc. from $14/$33)	44.2% (calc. from $19/$43)
Research & Development	$10,166	$14,424	$16,762
Selling, General & Administrative	$2,820	$7,132	$6,242
Total Operating Expenses	$12,986	$21,556	$23,004
Loss from Operations	$(12,981)	$(21,542)	$(22,985)
Interest Income, net	$463	$1,098	$1,375
Change in FV – Notes Payable	$(1,021)	$6,686	$(304)
Change in FV – Warrants	$(5,633)	$10,446	$4,703
Total Other Income (Expense), net	$(6,199)	$18,220	$5,756
Net Loss	$(19,180)	$(3,322)	$(17,229)

Liquidity

Metric	Q4 2023	Q1 2024	Q2 2024
Cash & Cash Equivalents	$33,209K	$121,441K	$102,439K
Working Capital	$24,460K	$111,200K	$92,274K
Total Assets	$76,212K	$163,519K	$146,437K

Revenue context: Pilot commercial activity in Germany; revenue was generated from the pilot in both Q2‑24 and Q2‑23 .
No segment reporting disclosed; revenue sources are limited to Germany pilot .

KPIs and Clinical/Operational Metrics

KPI	Q4 2023/Earlier	Q1 2024	Q2 2024
Germany Revita patients treated (cumulative)	29 treated; 24 enrolled in registry (as of Mar 15, 2024)	33 treated; 26 enrolled; interim 19 with follow‑up	37 treated; 31 consented to registry
3‑month outcomes	—	>1% median HbA1c reduction; >15 lbs weight loss; 95% stable/reduced ADAs	—
6‑month outcomes	—	Avg. >8% body weight loss; median HbA1c from 9.2% to 7.6% (n=14)	—
12‑month outcomes	—	—	Median weight 111→97 kg (~13% TBWL); HbA1c 9.6%→7.2% (n=11); meds stable/decreased in 10/11; no procedure‑related adverse safety events
Rejuva preclinical	GLP‑1 PGTx 27% TBWL at day 28 vs 21% for sema; maintained weight after sema withdrawal (mouse)	New data vs semaglutide in db/db model (single dose)	H2H DIO model: after sema withdrawal, Rejuva maintained fat reduction 17% and weight loss 22% at week 8; #1 ADA abstract

Guidance Changes

Metric/Topic	Period	Previous Guidance	Current Guidance	Change
REVITALIZE‑1 topline (T2D pivotal)	Data timing	Topline in 4Q 2024	Topline in mid‑2025	Lowered/Delayed
REMAIN‑1 initiation (obesity weight maintenance post‑GLP‑1)	Start/data cadence	Initiate H2 2024; begin open‑label updates in H2 2024	Initiated 3Q 2024; open‑label data in 4Q 2024; mid‑point analysis 2Q 2025	Raised/Accelerated
FDA Breakthrough Device (Revita – weight maintenance)	Regulatory	Not disclosed previously	Granted July 2024; enables priority review and potential earlier CMS decision	New Positive
Rejuva RJVA‑001 IND‑enabling	Timing	Complete 2H 2024	On‑track 2H 2024	Maintained
First‑in‑human (Rejuva)	Start	1H 2025 planned	1H 2025 planned	Maintained
Cash runway	Liquidity	Through 2025	Into 4Q 2025	Clarified/Maintained

Earnings Call Themes & Trends

Note: We attempted to retrieve the Q2 2024 earnings call transcript but encountered a system document error; we will update this section upon transcript availability. The trends below reflect management’s press releases across the last three quarters.

Topic	Previous Mentions (Q4‑23 and Q1‑24)	Current Period (Q2‑24)	Trend
Regulatory (Revita)	IDE for REMAIN‑1 received; CE mark in EU; NUB in Germany	FDA Breakthrough Device designation for weight maintenance post‑GLP‑1	Improving regulatory posture
T2D Pivotal (REVITALIZE‑1)	Enrollment completing; topline expected 4Q24	Topline shifted to mid‑2025; protocol broadened to any GLA (incl. GLP‑1/insulin) expanding potential US population ~6x to ~25M	Timeline extended; scope expanded
Obesity weight maintenance (REMAIN‑1)	Initiation expected H2‑24; open‑label REVEAL‑1 updates planned	Pivotal initiated 3Q‑24; open‑label data 4Q‑24; mid‑point analysis 2Q‑25	Accelerated execution
Real‑world Germany outcomes	Early 3‑ and 6‑mo signals: >1% HbA1c drop; >15 lbs weight loss; >8% 6‑mo TBWL	12‑mo data: ~13% TBWL; HbA1c 9.6%→7.2%; meds stable/decreased in 10/11; no procedure AEs	Strengthening durability
Rejuva GLP‑1 PGTx	Preclinical weight loss vs sema; IND‑enabling 2H‑24; 1H‑25 first‑in‑human	H2H preclinical data post‑sema withdrawal: sustained fat/weight effects; #1 ADA abstract	Positive validation momentum
Commercial readiness	Named CCO (Adrian Kimber) to prep for launch	— (focus on clinical milestones)	Building capabilities

Management Commentary

“We believe the recent FDA Breakthrough Device designation for Revita underscores our differentiated approach to the weight maintenance problem and provides further validation for this platform… our Rejuva GLP‑1 pancreatic gene therapy platform can durably improve body composition and blood sugar compared to semaglutide, and prevent weight regain after stopping semaglutide.” — Harith Rajagopalan, CEO .
On execution and catalysts: “We have significant upcoming milestones across both Revita and Rejuva which will be foundational to our goal of developing potentially one‑time, disease‑modifying solutions in the pursuit of durable improvement in obesity and T2D.” .
Financial posture: cash and equivalents of $102.4M as of 6/30/24, runway into 4Q25 .

Q&A Highlights

We were unable to retrieve the Q2 2024 earnings call transcript due to a system document error, so detailed Q&A themes and management responses are unavailable. We will update with top 3–5 analyst themes, guidance clarifications, and tone shifts once the transcript is accessible.

Estimates Context

Street consensus (S&P Global) for Q2 2024 EPS and revenue was not retrievable at time of analysis due to a temporary S&P Global data limit. As a result, we cannot determine beat/miss versus consensus for revenue or EPS this quarter (S&P Global consensus unavailable).
Given minimal commercial revenue and early‑stage P&L dynamics (non‑cash fair value items), investor focus should remain on clinical/regulatory catalysts rather than quarterly EPS variability .

Key Takeaways for Investors

Regulatory de‑risking: Breakthrough Device designation for weight maintenance post‑GLP‑1 is a meaningful validator and could accelerate US review/reimbursement path upon positive REMAIN‑1 data .
Near‑term data flow: REVEAL‑1 open‑label data (4Q24) and REMAIN‑1 mid‑point (2Q25) create interim catalysts while REVITALIZE‑1 topline shifted to mid‑2025, modestly extending T2D pathway .
Clinical durability: 12‑month real‑world registry outcomes (Germany) indicate durable TBWL (~13%) and HbA1c improvement with stable/decreasing meds, supporting a weight‑maintenance narrative post‑GLP‑1 .
Investment ramp aligned to pipeline: Elevated R&D reflects REMAIN‑1 initiation, REVITALIZE‑1 scale‑up, and Rejuva advancement; watch operating discipline versus runway into 4Q25 .
Rejuva optionality: #1 ADA abstract and H2H preclinical data vs sema suggest potential for durable efficacy and weight maintenance after GLP‑1 withdrawal; IND‑enabling on‑track for RJVA‑001 in 2H24 and first‑in‑human in 1H25 .
Risk‑reward skewed to data outcomes: The delayed REVITALIZE‑1 timeline raises execution risk, but multiple interim readouts and Breakthrough status provide offsetting catalysts .
Trading lens: Shares are likely to be catalyst‑driven in 4Q24–2Q25; positioning ahead of REVEAL‑1 open‑label readout and Breakthrough‑enabled updates may be impactful, while downside risk ties to timeline slippage or weaker‑than‑expected durability signals .

Appendix: Additional Detail

Revenue source: “Revenue in each of the quarters ended June 30, 2024 and 2023 was generated from the Company's pilot commercial launch in Germany.”
Cash runway: “Sufficient to fund operations through expected key company milestones into the fourth quarter of 2025.”
Expanded REVITALIZE‑1 protocol: eligibility broadened to T2D on any glucose‑lowering agent (including GLP‑1 and/or insulin), expanding potential US treatment population ~6x to ~25M .

FRACTYL HEALTH, INC. (GUTS)·Q2 2024 Earnings Summary