Executive Summary

Q3 2023 was execution-focused ahead of the pivotal STRIDE topline; Reneo reported a net loss of $19.2M (–$0.57 per share) and ended the quarter with $125.6M in cash, cash equivalents, and short-term investments, positioning the company into the December STRIDE readout catalyst .
Management reiterated the December 2023 timing for STRIDE topline and highlighted strong patient engagement with an 88% rollover rate into STRIDE AHEAD and 65 patients treated beyond 52 weeks, underscoring durability/interest in the program .
Operating expenses rose year over year on clinical, CMC, medical affairs, and commercial readiness spend; R&D was $13.6M (+$3.7M YoY) and G&A was $7.3M (+$3.4M YoY), driving the YoY widening of net loss .
Capital allocation included repurchasing 576,443 shares from vTv Therapeutics for ~$4.4M on Oct 30 (post-quarter), modestly reducing share count; management also noted a USPTO Notice of Allowance, extending IP visibility (anticipated expiration 2041) .
Wall Street consensus estimates (S&P Global) were unavailable for RPHM this quarter; no estimate comparisons are provided due to missing mapping in S&P Global systems (attempted retrieval failed).

What Went Well and What Went Wrong

What Went Well
- Completed last patient last visit in STRIDE; topline results expected in December 2023, preserving a near-term binary catalyst .
- Strong patient engagement: 88% of eligible STRIDE patients enrolled into STRIDE AHEAD; 65 patients treated beyond 52 weeks, supporting longer-term exposure and safety observations .
- Pipeline/IP momentum: First PMM patient with a nuclear DNA defect enrolled in STRIDE AHEAD; received USPTO Notice of Allowance for PPAR-δ agonist use patent (anticipated expiration 2041) .
What Went Wrong
- Elevated OpEx: R&D rose to $13.6M, driven by clinical development, CMC for marketing registration (+$2.2M), medical affairs (+$1.0M), and personnel (+$0.9M); G&A increased to $7.3M on commercial development and headcount (+$2.1M and +$1.2M, respectively) .
- Net loss widened YoY: Q3 net loss was $19.2M vs $13.0M in Q3 2022 (EPS –$0.57 vs –$0.53), reflecting scaled pre-commercial and development activities .
- No revenue generation and no gross/margin metrics yet; operating performance remains fully tied to clinical milestones and financing cadence (no revenue line reported in the quarter’s P&L presentation) .

Financial Results

Quarterly P&L and per-share metrics

Metric	Q1 2023	Q2 2023	Q3 2023
R&D Expense ($USD Millions)	$11.0	$14.4	$13.6
G&A Expense ($USD Millions)	$5.1	$6.6	$7.3
Total Operating Expenses ($USD Millions)	$16.1	$21.0	$20.9
Loss from Operations ($USD Millions)	$(16.1)	$(21.0)	$(20.9)
Other Income ($USD Millions)	$1.0	$1.5	$1.7
Net Loss ($USD Millions)	$(15.1)	$(19.5)	$(19.2)
Diluted EPS ($)	$(0.60)	$(0.65)	$(0.57)
Weighted Avg Shares (Millions)	25.04	30.22	33.81

Balance sheet liquidity (period-end)

Metric	Q1 2023	Q2 2023	Q3 2023
Cash & Cash Equivalents ($USD Millions)	$30.4	$9.1	$11.7
Short-term Investments ($USD Millions)	$63.4	$133.6	$113.9
Cash + ST Investments ($USD Millions)	$93.8	$142.7	$125.6

Q3 Year-over-Year comparison

Metric	Q3 2022	Q3 2023
R&D Expense ($USD Millions)	$9.9	$13.6
G&A Expense ($USD Millions)	$3.9	$7.3
Total Operating Expenses ($USD Millions)	$13.8	$20.9
Net Loss ($USD Millions)	$(13.0)	$(19.2)
Diluted EPS ($)	$(0.53)	$(0.57)

Notes: The company reports no product revenue and presents operating expenses and losses; margin metrics (gross/EBITDA) are not applicable at this stage .

KPIs and program execution

KPI	Q1 2023	Q2 2023	Q3 2023
STRIDE Enrollment Status	Completed enrollment (213 patients; topline 4Q23)	Topline anticipated 4Q23	Last patient last visit completed; topline December 2023
STRIDE AHEAD OLE Enrollment	>100 enrolled; >50 reached 6 months	>130 enrolled	88% rollover of eligible STRIDE; 65 treated >52 weeks
First nDNA Patient in OLE	—	Inclusion criteria expanded to allow nDNA	First nDNA patient dosed
Capital Raises/Repurchases	Offering announced/completed in May (Public: net ~$58.2M; Private: net ~$4.7M)	Public + private gross $68.3M; net proceeds ~$63.5M	Repurchased 576,443 shares for ~$4.4M (10/30)
IP/Regulatory	Fast Track (LC-FAOD genotype) noted earlier in 2023	—	USPTO Notice of Allowance; patent expected to expire 2041

Guidance Changes

Metric	Period	Previous Guidance	Current Guidance	Change
STRIDE topline results timing	4Q 2023	“Anticipated in 4Q23” (Q2 update)	“Expected in December 2023” (Q3 update)	Maintained/Narrowed window
NDA submission timing (mavodelpar for PMM, U.S.)	1H 2024	“Anticipated 1H24” (Q2 update)	Not reiterated in Q3 PR	NR (no reiteration)
Financial guidance (Revenue, Margins, OpEx)	2023	Not provided	Not provided	No change

Earnings Call Themes & Trends

Note: No earnings call transcript was available for Q3 2023; themes below draw from quarterly press releases.

Topic	Previous Mentions (Q1 2023, Q2 2023)	Current Period (Q3 2023)	Trend
Pivotal STRIDE timing/readiness	Q1: Enrollment complete; topline 4Q23 . Q2: Topline anticipated 4Q23 .	LPLV completed; topline in December 2023	On track; window narrowed
Patient engagement (OLE)	Q1: >100 OLE; >50 at 6 months . Q2: >130 OLE .	88% rollover; 65 >52 weeks	Strengthening engagement
nDNA PMM development	Q1: Plan to initiate nDNA enrollment	Inclusion criteria expanded (Q2) ; First nDNA patient dosed (Q3)	Execution progress
Commercial/medical readiness	Q1: Preparing for commercialization	G&A increase tied to commercial development	Investment continues
Capital strategy	Q1/Q2: Equity financings completed	Post-Q3: $4.4M repurchase (vTv)	Opportunistic deployment
IP/regulatory	Q1: Fast Track (LC-FAOD genotype)	Q3: USPTO Notice of Allowance; expiry 2041	IP strengthened

Management Commentary

“We are looking forward to sharing topline results of our pivotal STRIDE study in December…we continue to be encouraged by the high participation rate in our STRIDE AHEAD open-label extension study…This is a very exciting time for the Reneo team” — Gregory J. Flesher, President & CEO .
“We are looking forward to topline results from our pivotal STRIDE study…Our recent financing extended our runway…sufficient capital to fund operations beyond the potential submission of a new drug application…anticipated in the first half of 2024.” — Gregory J. Flesher (Q2) .
“We have been encouraged by…over-enrollment in STRIDE and high rate of rollover into the STRIDE AHEAD…We expect that [additional capital] will be utilized…including the potential filing of a new drug application in the first half of 2024.” — Gregory J. Flesher (Q1) .

Q&A Highlights

No earnings call transcript was available for Q3 2023; no Q&A themes or clarifications to report [ListDocuments showed none].

Estimates Context

Consensus estimates (S&P Global/Capital IQ) were unavailable for RPHM this quarter due to missing mapping in S&P’s CIQ company database; we attempted retrieval but could not obtain EPS or revenue consensus. As a result, no comparisons vs. Wall Street estimates are presented (GetEstimates error recorded).

Key Takeaways for Investors

December 2023 STRIDE topline is the key binary catalyst; patient engagement metrics (88% OLE rollover; 65 patients >52 weeks) support conviction in program continuity, though efficacy/safety outcomes remain binary .
Liquidity of $125.6M at 9/30/23 provides runway into and through the readout; prior financings plus disciplined OpEx will be critical if additional activities (NDA, potential launch readiness) ramp in 1H24 .
YoY OpEx growth reflects clinical/CMC, medical affairs, and commercial preparation; expect continued near-term spend intensity until pivotal milestones are resolved .
Post-quarter $4.4M share repurchase from vTv (576,443 shares) modestly reduces float and can alleviate an overhang; small capital deployment signals confidence heading into data .
IP strengthened via USPTO Notice of Allowance with anticipated 2041 expiry, enhancing longer-term asset defensibility if efficacy is demonstrated .
No revenue/margin metrics yet; valuation remains event-driven and contingent on STRIDE outcomes. In the near term, positioning into the catalyst (and hedging downside) is prudent given binary risk and lack of consensus benchmarks.

Citations:

Q3 2023 press release and financial statements within Form 8-K (Nov 13, 2023):
Q2 2023 press release and financial statements within Form 8-K (Aug 10, 2023):
Q1 2023 press release and financial statements within Form 8-K (May 11, 2023):

Reneo Pharmaceuticals, Inc. (RPHM)·Q3 2023 Earnings Summary