Executive Summary

Q2 2025 loss widened as R&D scaled for TX45/TX2100: net loss $19.984M; R&D $17.185M; G&A $5.147M; total operating expenses $22.332M . Cash and cash equivalents were $287.4M, providing runway into Q4’2028 .
Clinical momentum: TX45 Phase 1b Part B in PH-HFrEF completed enrollment (topline early Q4’25) and APEX Phase 2 in PH-HFpEF continues; company added PH-ILD as a new 2026 Phase 2 indication .
EPS of $(1.07) missed the Street’s $(0.98)* consensus; revenue was 0 vs 0 consensus*; higher operating spend and a discrete $0.976M tax expense tied to the Australia subsidiary dissolution contributed to the loss .
Notable corporate updates: inclusion in Russell 3000 (June), $173.1M private placement in Feb, and setup of a $100M ATM capacity (July) enhancing funding flexibility .
Near-term stock catalysts: TX45 Phase 1b Part B topline (early Q4’25), and clarity on APEX Phase 2 operational progress; medium-term catalysts include 2026 APEX topline, PH-ILD Phase 2 start, and TX2100 Phase 1 initiation .

What Went Well and What Went Wrong

TX45 clinical expansion: “Today our team is excited to announce PH-ILD as an additional indication for TX45… TX45’s preclinical and hemodynamic data… supports expanding into PH-ILD” — Alise Reicin, M.D., CEO .
Phase 1b Part B enrollment completed; APEX Phase 2 continues; data cadence overall intact (Part B topline early Q4’25; APEX topline 2026) .
Strengthened balance sheet: cash $287.4M at Q2 with runway into Q4’2028, aided by Feb 2025 financing, while interest income benefiting from higher cash balances .

Loss widened: net loss increased to $19.984M vs $15.906M in Q1 as operating expenses rose with TX45/TX2100 program activities .
EPS missed consensus: actual $(1.07) vs Street $(0.98)*, reflecting accelerated R&D execution and a discrete $0.976M tax expense from subsidiary dissolution .
No revenue generation (as expected for early-stage biotech), with reiterated need for substantial future capital to support trials and pipeline before commercialization .

Metric (USD, thousands unless noted)	Q4 2024	Q1 2025	Q2 2025
Cash and Cash Equivalents	$141,239	$306,246	$287,381
Research and Development	$9,155	$13,036	$17,185
General and Administrative	$4,834	$5,262	$5,147
Total Operating Expenses	$13,989	$18,298	$22,332
Net Loss	$12,373	$15,906	$19,984
Net Loss per Share (USD)	$(0.84)	$(0.93)	$(1.07)
Weighted Avg Shares	14,792,618	17,157,661	18,680,042

Revenue: Company reiterates no revenue since inception .

Metric	Actual	Consensus	# of Estimates
Revenue (USD)	$0	$0.0*	6*
EPS (USD)	$(1.07)	$(0.9817)*	6*

Values with * retrieved from S&P Global.

Metric	Period	Previous Guidance	Current Guidance	Change
Cash Runway	Through Q4’2028	Into Q4’28	Into Q4’28	Maintained
TX45 Phase 1b Part B topline (PH‑HFrEF)	Early Q4’2025	2H’25	Early Q4’25	Narrowed timing
TX45 APEX Phase 2 topline (PH‑HFpEF)	2026	2026	2026	Maintained
TX2100 Phase 1 start (HHT)	Q1’2026	Q4’25 or Q1’26	Q1’26	Shifted later (clarified)
TX45 PH‑ILD Phase 2 initiation	2026	Not specified	2026	New indication

No Q2 2025 earnings call transcript was filed; we reviewed the 8-K and 10-Q filings for narrative and trends .

Topic	Previous Mentions (Q4 2024 and Q1 2025)	Current Period (Q2 2025)	Trend
TX45 clinical execution	Interim Part A results (PCWP −17.9%, CO +17.4%); APEX initiated Oct 2024	Part B enrollment completed; APEX ongoing; complete Part A confirms stronger hemodynamics	Improving
Indication strategy	Focus on PH‑HFpEF; Part B planned in PH‑HFrEF	Added PH‑ILD Phase 2 in 2026, expanding opportunity	Expanding
Financing & runway	$141.2M cash YE 2024; PIPE gross ~$185M in Feb 2025	$287.4M cash; runway into Q4’28; ATM capacity $100M established	Strengthened
Macro/regulatory	Geopolitical/inflation risks; trial geography considerations	Similar macro disclosures; discrete $0.976M tax expense from subsidiary dissolution	Mixed
Competitive landscape	AZ relaxin programs; Tenax; others; Lilly volenrelaxin termination noted	Continued emphasis on best‑in‑class TX45 profile	Stable narrative

“PH‑ILD is a devastating disease… TX45’s preclinical and hemodynamic data… supports expanding into PH‑ILD.” — Alise Reicin, M.D., President & CEO .
Part B enrollment completed with topline early Q4’25; APEX Phase 2 continues toward 2026 topline .
Cash runway guidance: “cash and cash equivalents… expected to provide a cash runway into Q4’2028” .

No Q2 earnings call transcript on file; therefore, no Q&A highlights or additional guidance clarifications beyond the 8‑K and 10‑Q disclosures .

EPS missed consensus: actual $(1.07) vs $(0.9817); revenue matched at $0 vs $0.0; # of estimates = 6* for both .
Forward context: Q3 2025 EPS consensus −1.0471* and revenue 0.0*, consistent with ongoing pre‑commercial status; rising R&D run‑rate implies estimates may drift lower absent offsets [GetEstimates].

Values with * retrieved from S&P Global.

Loss widening is primarily investment-driven: R&D up 31% q/q to $17.2M as TX45/TX2100 advance; expect elevated OpEx until clinical milestones pass .
Near-term catalyst: TX45 Part B topline early Q4’25 could expand addressable population (PH‑HFrEF) and improve sentiment; monitor hemodynamic endpoints .
Medium-term: 2026 APEX Phase 2 topline in PH‑HFpEF and PH‑ILD Phase 2 initiation underpin a multi‑indication strategy; execution risk remains but optionality improves .
Balance sheet supports multi‑program execution: $287.4M cash and Q4’28 runway; $100M ATM adds flexibility, but dilution risk if tapped amid market volatility .
Estimate tuning: EPS likely pressured by higher R&D and tax discrete items; consensus already assumes zero revenue — adjustments may focus on OpEx trajectory and timing of readouts .
Trading angle: Pre‑readout biotech dynamics — data cadence (Q4’25), index inclusion, and program expansion could attract incremental interest; downside tied to delays or weaker hemodynamics vs expectations .
No revenue; commercialization horizon remains years away — thesis hinges on clinical de‑risking and capital discipline .

Q2 2025 8‑K 2.02 press release (full text read) .
Q2 2025 10‑Q (full filing read for detailed financials and MD&A) .
Prior quarter context: Q1 2025 10‑Q ; Q4 2024 earnings 8‑K .
Q2 2025 earnings call transcript and other Q2 press releases: none found in the document catalog [ListDocuments results].