Executive Summary

Q2 delivered operational momentum but a mixed P&L: zero revenue, reduced operating spend year over year, and a narrower sequential loss per share; EPS of $(0.49) missed S&P consensus of $(0.40)* primarily due to share count dynamics and non-cash warrant items .
MIRACLE (Phase 2B/3) advanced: four sites active (Ukraine, Georgia, Spain, US), with >20 additional EU/US sites expected to begin recruitment by Q3; Part A 45-subject unblinding remains targeted before year-end 2025—an explicit near-term stock catalyst .
Cash runway extended: cash and equivalents of $7.6M at 6/30/25 (vs. $7.7M at 3/31/25), with post-quarter $6.0M gross proceeds from warrant exercises supporting operations; the company guides cash sufficiency into Q4 2025 .
Strategic breadth expanding: positive STS lung metastases topline (median OS 13.5 months in heavily pretreated cohort) and new IP progress underscore optionality beyond AML .

What Went Well and What Went Wrong

What Went Well

MIRACLE trial execution: “Four active MIRACLE sites now screening subjects in Ukraine, Georgia, Spain and the US” with >20 additional sites expected by end of Q3; Part A 45-subject unblinding targeted before YE25 .
Pipeline validation: positive topline efficacy in STS MB-107 (median OS 13.5 months in median 7th-line patients, comparing favorably to 8–12 months SOC and 13.4 months experimental 2L benchmarks) .
Management tone on momentum: “positioning ourselves to achieve our enrollment targets and…reach an expected pivotal data readout before the end of this year” — Walter Klemp, CEO .

What Went Wrong

EPS miss vs. consensus: Q2 EPS of $(0.49) vs. S&P consensus $(0.40)*; composition of P&L continues to be impacted by non-cash warrant valuation gains/losses and issuance-related charges .
Share count dilution: weighted average shares 15.53M in Q2 vs. 2.54M YoY, reflecting financings; post-quarter, company enabled additional warrant exercises (dilutive) to raise ~$6.0M gross .
Equity deficit and rising liabilities: warrant liability rose to $20.6M at 6/30/25 from $5.2M at 12/31/24; stockholders’ equity turned negative $(7.2)M as of Q2-end .

Financial Results

P&L and EPS vs. Estimates (all amounts in $USD Thousands except per-share)

Metric	Q2 2024	Q1 2025	Q2 2025
Revenues	$0	$0	$0
Research & Development	$4,090	$3,435	$3,600
G&A + D&A	$2,095	$2,508	$2,120
Total Operating Expenses	$6,185	$5,943	$5,720
Loss from Operations	$(6,185)	$(5,943)	$(5,720)
Gain (Loss) FV Warrant Liability	$1,696	$9,054	$9,609
Transaction Costs to Warrant Liabilities	$0	$(1,788)	$(1,207)
Loss on Issuance of Warrant Liabilities	$0	$(7,798)	$(10,352)
Interest Income, net	$159	$30	$26
Net Loss	$(4,319)	$(6,436)	$(7,640)
Diluted EPS	$(1.70)	$(0.69)	$(0.49)
Diluted EPS – S&P Consensus	—	—	$(0.40)*

Notes: EPS consensus values marked with * are from S&P Global. Values retrieved from S&P Global.

Balance Sheet Highlights

Metric ($USD Thousands)	Dec 31, 2024	Mar 31, 2025	Jun 30, 2025
Cash & Cash Equivalents	$4,278	$7,716	$7,557
Current Liabilities	$5,359	$6,896	$7,913
Warrant Liability	$5,229	$13,749	$20,553
Total Liabilities	$10,946	$20,971	$28,758
Stockholders’ Equity (Deficit)	$5,979	$42	$(7,165)

KPIs (Clinical and Operating)

Active MIRACLE sites screening: 4 (Ukraine, Georgia, Spain, US) .
Additional sites expected by end of Q3: >20 (EU and US) .
MIRACLE Part A first unblinding (n=45): targeted before end of 2025 .
STS MB-107 median OS: 13.5 months in median 7th-line (n=36) .

No revenue segments/KPIs applicable; company is pre-revenue.

Guidance Changes

Metric	Period	Previous Guidance	Current Guidance	Change
MIRACLE Part A 45-subject unblinding	2H 2025	“2H 2025”	“Q4 2025” (still 2H; more specific)	Maintained (refined timing)
First patients treated in US/EU	2025	First subject treated expected Q1 2025 (global start) ; First patient dosed announced Apr 1, 2025	“Q3 2025 – First patients treated in the US and the EU” (regional milestone)	Clarified (regional specificity)
Cash runway	2025	Sufficient into Q3 2025	Sufficient into Q4 2025	Raised
STS MB-107 data	1H 2025	Final data readout by end of June	Positive topline reported; next step: identify pivotal IIT in Q4 2025	Achieved/advanced

Earnings Call Themes & Trends

Topic	Previous Mentions (Q4’24 call; Q1’25 update)	Current Period (Q2’25)	Trend
MIRACLE design & unblinding cadence	Multiple unblindings (n=45 in 2H25; n=75–90 in 1H26), quick read on CR at ~day 35	Confirms 45-subject unblinding before YE25; 1H26 second unblinding	On track
Dose selection under Project Optimus	Two doses (190 vs 230 mg/m2); selection based on efficacy/safety/PK	Consistent with FDA guidance; selection after Part A	Consistent
Non-cardiotoxic anthracycline thesis	Emphasized lack of cardiotoxicity and overcoming venetoclax resistance	Reinforced in program overview	Reinforced
Sites/Geography	Sequencing of starts: non‑EU/Middle East → EU → US; 25 sites targeted initially	4 active sites; >20 more expected by end Q3	Accelerating
Capital & burn	~$5M/quarter in 2025, stepping up in 2026 for CMC	Q2 OpEx $5.72M; runway to Q4’25; post‑quarter $6M gross via warrant exercises	In line; liquidity bolstered
STS next steps	Pivotal IIT interest in EU; strong late-line OS vs benchmarks	Positive topline; plan to identify pivotal IIT in Q4’25	Advancing

Management Commentary

“We continued to make meaningful progress in our MIRACLE trial… positioning ourselves to achieve our enrollment targets and… reach an expected pivotal data readout before the end of this year.” — Walter Klemp, Chairman & CEO .
On potential early strength at interim: “If Annamycin does as well as it did in the Phase 2… then we probably hit that number… to accelerate approval even faster” (subject to safety/PK and alpha spending) .
On dosing strategy: “FDA wanted us to go to a lower dose… we used 190 in 106 and saw efficacy… both [190 and 230] will work to a reasonably similar degree” — Dr. John Paul Waymack, Senior CMO .

Q&A Highlights

Dose selection and early stopping: Management outlined multi‑variable criteria (efficacy, safety, PK) and alpha constraints; Part A could determine a winner at n=45, but selection may also occur by n=75–90 .
Trial cost and burn: ~$60–70M if fully enrolled; 2025 burn ~$5M/quarter, rising in 2026 for CMC as NDA planning begins .
STS pivotal path: Late-line OS viewed as compelling; leading EU sarcoma center expressed interest in a pivotal IIT; dosing around ~300 mg/m2 in monotherapy for STS anticipated, subject to FDA EOP2 feedback .

Note: We did not find a Q2 2025 earnings call transcript in the document set. Q4 2024 call content is used for prior-quarter Q&A themes . No Q2 2025 call transcript was available in our search window.

Estimates Context

Q2 2025 EPS: $(0.49) vs. S&P consensus $(0.40)* → miss of $(0.09) (~22% more negative). Revenue: $0 vs. $0* (in line) .
Forward context: Q3 2025 EPS consensus is $(0.26); FY25 EPS consensus $(1.24); 12‑month target price consensus $6.67* (3 estimates). Values retrieved from S&P Global.

Key Takeaways for Investors

Near-term binary-ish catalyst: 45-subject unblinding from MIRACLE Part A targeted for Q4 2025; complete remission rates vs HiDAC‑placebo will shape regulatory path and partnering leverage .
Execution ramping: 4 active sites with >20 more expected by end of Q3 suggests accelerating enrollment trajectory into year-end .
Liquidity extended: runway into Q4 2025, aided by post‑quarter ~$6.0M warrant exercise proceeds; however, financing risk and dilution remain live issues for 2026+ execution .
P&L optics: headline EPS is driven by non-cash warrant remeasurements and issuance charges; underlying OpEx trend is improving YoY and aligns with the ~$5M/quarter burn guide .
Optionality beyond AML: STS MB‑107 topline (median OS 13.5 months in late‑line) and new IP suggest additional value paths, with a pivotal IIT decision targeted in Q4 2025 .
Dosing and risk management: Project Optimus-driven dose selection (190 vs 230 mg/m2) should be clarified by Part A; management expects both doses to be active, which may de‑risk selection .

Appendix: Source Documents and Data

Q2 2025 8‑K 2.02 and press release, including financial statements and MIRACLE updates .
Q2 2025 standalone press release (mirror of Exhibit 99.1 content) .
Prior quarter Q1 2025 8‑K 2.02 and financials .
FY 2024 8‑K update (baseline milestones and liquidity) .
Post‑quarter updates: warrant exercise gross proceeds ~$6.0M (Aug 28, 2025) .
Q4 2024 earnings call transcript for historical context and Q&A .

Estimates: Marked with *; Values retrieved from S&P Global.

Moleculin Biotech, Inc. (MBRX)·Q2 2025 Earnings Summary