Executive Summary

Q2 showed operational progress and a narrower loss: net loss improved to $1.9M ($1.16/share) from $4.2M ($10.64/share) in Q2’23; R&D declined on lower manufacturing costs, while G&A was stable .
Clinical momentum was a focal point: interim Phase 2 AML data were showcased at ASCO (oral) and EHA (poster), with management emphasizing safety and efficacy signals from prexigebersen combos in high‑risk populations .
Balance sheet was strengthened with a $4.0M private placement closed in June, lifting cash to $4.0M at quarter-end (vs. $1.1M at 12/31/23) and $7.2M financing inflows YTD through 6/30/24 .
Subsequent update post‑quarter highlighted a tumor reduction and continued stable disease in a solid tumor patient at a higher dose of BP1001‑A, supporting platform optionality and adding a potential near‑term sentiment catalyst .
The company did not provide quantitative financial guidance or discuss consensus benchmarks; estimate comparisons are therefore not available from S&P Global at this time .

What Went Well and What Went Wrong

What Went Well

High‑profile clinical visibility: interim AML data with prexigebersen + decitabine + venetoclax presented at ASCO and EHA; management called the first half “an undeniably productive period” and highlighted efficacy signals in difficult AML populations .
Expense discipline: R&D expense decreased to $1.9M in Q2’24 (from $3.1M in Q2’23) primarily on lower manufacturing spend; net loss narrowed YoY .
Liquidity improved: closed a $4.0M private placement in June, ending Q2 with $4.0M in cash and $7.2M YTD financing inflows through 6/30/24, bolstering funding for clinical execution .

Quotes

“The first half of 2024 was an undeniably productive period for Bio‑Path.” — Peter Nielsen, CEO .
“We were encouraged by the bolus of data we presented at ASCO and EHA…” — Peter Nielsen, CEO .

What Went Wrong

Program pauses and pacing: the Phase 2 AML study was paused for interim analysis/amendment and FDA review; enrollment in cohorts 1 and 2 expected to take ~18 months to complete, extending timelines .
Continued operating losses: despite YoY improvement, the company remains loss‑making with $1.9M net loss in Q2’24; G&A held at $1.2M, reflecting ongoing corporate costs .
Limited transparency on forward metrics: no quantitative financial guidance or estimate framing in the press release or prepared remarks, limiting near‑term visibility for investors .

Financial Results

Metric	Q2 2023	Q1 2024	Q2 2024
Net Loss ($USD Millions)	$4.2	$3.2	$1.9
Diluted EPS ($)	$10.64	$4.88	$1.16
R&D Expense ($USD Millions)	$3.1	$2.3	$1.9
G&A Expense ($USD Millions)	$1.2	$1.4	$1.2

Liquidity and Cash Flow

Metric	Dec 31, 2023	Mar 31, 2024	Jun 30, 2024
Cash and Equivalents ($USD Millions)	$1.1	$0.2	$4.0
Net Cash Used in Operating Activities (YTD, $USD Millions)	—	$1.0 (Q1)	$4.3 (H1)
Net Cash Provided by Financing Activities (YTD, $USD Millions)	—	$3.5 (post‑Q1)	$7.2 (H1)

Clinical KPIs and Program Status (select)

KPI / Program	Q4 2023	Q1 2024	Q2 2024
Prexigebersen AML Phase 2 interim data	Positive interim signals; pursuing expeditied pathways discussed	“Compelling” interim signals reiterated	Presented at ASCO (oral) and EHA (poster)
Cohort 1 (ND AML) interim responses	—	—	75% CR/CRh/CRi in 20 evaluable (15/20); plus PRs/SD detailed
Cohort 2 (R/R AML) interim responses	—	—	55% CR/CRi/CRh in 23 evaluable (12/23); plus PR/SD/failure detailed
AML Phase 2 status	—	—	Paused for interim analysis/amendment/FDA review; plan to complete cohort 1 & 2 enrollment over ~18 months
BP1002 AML (BCL‑2) dose escalation	First cohort completed	Second cohort completed	Second cohort completion reiterated; moving toward next dose pending FDA
BP1002 Lymphoma/CLL	First cohort completed	Enrolling second cohort 40 mg/m2	Enrollment continued; aim to complete and review by year end
BP1001‑A Solid Tumors	Trial ongoing start described	Ongoing; potential data later in 2024	Advanced to dose level 2 (90 mg/m2)

Notes: ND = newly diagnosed; R/R = relapsed/refractory; Response definitions per AML standards. Adverse events at EHA were consistent with decitabine/venetoclax/AML expectations .

Guidance Changes

Metric	Period	Previous Guidance	Current Guidance	Change
Financial guidance	—	—	None provided in press release or prepared remarks	—
Clinical timelines	AML Phase 2	—	Enrollment in cohorts 1 & 2 expected to complete over next ~18 months	New disclosure

Earnings Call Themes & Trends

Topic	Q4 2023 (Prior-2)	Q1 2024 (Prior-1)	Q2 2024 (Current)	Trend
AML (prexigebersen) efficacy/safety	Positive interim; exploring expedited pathways (Fast Track)	“Compelling” interim signals reiterated	ASCO oral/EHA poster; continued safety/efficacy signals	Sustained positive narrative
Biomarkers	—	—	Molecular biomarker package to refine patient selection	New precision focus
BP1002 (BCL‑2)	First cohort completed	Second cohort (AML) completed; Lymphoma/CLL moving to 40 mg/m2	Advancing to next AML dose pending FDA; Lymphoma/CLL enrollment continues	Steady advancement
BP1001‑A (Solid tumors)	Trial ongoing	Ongoing; potential readout later in year	Advanced to dose level 2; subsequent update: tumor reduction/stable disease at 90 mg/m2	Increasing optionality
Regulatory	Discussed intent to pursue Fast Track	Reiterated expedited pathway intentions	No new regulatory status disclosed	Awaiting updates
Financing/liquidity	Cash $1.1M at YE23	$3.5M raised post‑Q1	$4.0M private placement closed; cash $4.0M at Q2‑end	Improved funding
New indications	—	—	Announced preclinical obesity program planning	Pipeline expansion

Management Commentary

“The first half of 2024 was an undeniably productive period for Bio‑Path…executed our strategy to achieve both clinical and corporate objectives.” — Peter Nielsen, CEO .
“We were encouraged by the bolus of data we presented at ASCO and EHA…as they underscore the potential of a prexigebersen combination regimen as a safe and effective treatment for some of the most vulnerable cancer patients.” — Peter Nielsen, CEO .
“We’ve strengthened our balance sheet in recent weeks with a $4 million financing. This additional funding provides the financial underpinning from which to execute on our clinical development plan.” — Peter Nielsen, CEO .
“The company reported a net loss of $1.9 million or $1.16 per share…R&D decreased to $1.9 million…G&A was $1.2 million…Cash of $4.0 million at June 30, 2024.” — Anthony Price, CFO .

Q&A Highlights

The Q2 transcript provided contains management’s prepared remarks and cue to open Q&A but does not include any analyst Q&A content; no guidance clarifications were captured in the transcript .
For context, prior Q4’23 Q&A covered Fast Track ambitions in AML and expected dose levels and sequencing for BP1002 across AML and CLL/lymphoma, indicating intent to move to 60–90 mg/m2 in combination phases post‑monotherapy escalation .

Estimates Context

We attempted to retrieve S&P Global (Capital IQ) consensus for Q2’24 EPS and revenue; data could not be retrieved at this time. As such, beat/miss versus consensus cannot be assessed here. Company materials did not reference Street estimates or provide quantitative financial guidance .

Key Takeaways for Investors

Clinical credibility is building: ASCO/EHA visibility and positive interim AML data with prexigebersen support a constructive efficacy/safety profile in fragile AML populations, a difficult‑to‑treat segment .
Expense reduction is helping narrow losses: YoY R&D decline from lower manufacturing spend helped compress the Q2’24 net loss despite continued pipeline execution .
Funding runway improved: June private placement and H1 financing flows lifted quarter‑end cash; continued clinical progress will likely require further capital over time .
Watch the AML trial cadence: the interim analysis/FDA amendment pause and ~18‑month enrollment plan for cohorts 1–2 frame the next clinical inflection timing; biomarker‑guided selection may enhance future response rates .
Solid tumor optionality is emerging: advancement to higher BP1001‑A dose and a subsequent tumor reduction signal support platform translatability beyond hematologic cancers .
Regulatory path is a medium‑term catalyst: prior commentary about expedited pathways (e.g., Fast Track) remains a potential de‑risking event pending future regulatory interactions .
With no formal guidance or available consensus, trading cues will skew to clinical updates (enrollment progress, additional interim data, BP1002 dosing transitions, and BP1003 IND steps) and financing developments .

Appendix: Additional Relevant Press Releases (Q2 timeframe)

June 5, 2024: Closed $4.0M private placement (terms and intended use of proceeds) .
June 14, 2024: EHA interim AML data — response rates and AE profile; plan to continue enrollment .
July 8, 2024: Clinical update — AML Phase 2 interim analysis/pause, biomarker package, BP1001‑A dose advancement, BP1002 AML/lymphoma cohort status, obesity preclinical plans .
August 21, 2024 (post‑Q2): Positive BP1001‑A patient response and ongoing AML patient durability on triple combo .

Sources: Q2’24 8‑K and Exhibit 99.1 press release , Q2’24 earnings call transcript , Q1’24 8‑K and transcript , FY’23 8‑K and Q4’23 transcript , other press releases .

BIO-PATH HOLDINGS, INC. (BPTH)·Q2 2024 Earnings Summary