Executive Summary

Q4 2024 delivered a narrower net loss and improved diluted EPS versus prior year; diluted EPS of $1.74 loss compared to $3.18 loss in Q4 2023, with net loss of $8.2M vs $8.6M YoY .
Management extended CHASE Phase 2b enrollment after masked data review to account for 13 non-verified PCED cases; topline timing shifted from 2Q25 to 3Q25, a modest delay but aimed at trial integrity .
Cash resources were $51.2M at year-end, runway extended into 1Q 2026 following a $10.75M private placement and debt prepayment; operational flexibility improved despite ongoing R&D spend .
CEO transition in February 2025 (Bazemore to interim CEO) frames near-term execution focus on KPI-012 and CHASE milestones; additional Latin America sites activated broaden enrollment footprint .
EPS compared to Wall Street: S&P Global “Primary EPS” consensus for Q4 2024 was -$2.28 vs actual Primary EPS -$1.23, a significant beat; company-reported diluted EPS was -$1.74 (methodological differences) . Values retrieved from S&P Global*

What Went Well and What Went Wrong

What Went Well

Enrollment progress and trial rigor: 87 patients randomized; enrollment extended to address non-verified PCED cases, preserving data quality. “We have decided to extend enrollment…now plan to report topline results in the third quarter of 2025.” — Todd Bazemore .
Balance sheet strengthened: $10.75M private placement completed; cash runway extended into 1Q 2026, aided by CIRM funding and a $5.0M debt prepayment .
Operating metrics improved YoY in Q4: net loss narrowed to $8.2M and diluted EPS improved to -$1.74 from -$3.18; G&A declined YoY on lower employee-related costs .

What Went Wrong

Timeline slip: CHASE topline moved from 2Q25 (prior guide) to 3Q25 due to enrollment extension, delaying potential pivotal-readout catalysts by a quarter .
Continued operating losses with rising R&D: Q4 operating loss of $9.5M; R&D up YoY reflecting KPI-012 advancement and employee costs .
Debt still material despite prepayment: current portion of long-term debt $10.3M and long-term debt net $20.1M at year-end (post-prepayment), suggesting ongoing financing discipline will remain necessary .

Financial Results

Metric	Q4 2023	Q2 2024	Q3 2024	Q4 2024
Revenue ($USD Millions)	N/A	N/A	N/A	N/A
Operating Loss ($USD Millions)	$9.62	$9.61	$9.99	$9.46
Net Loss ($USD Millions)	$8.63	$9.58	$8.95	$8.18
Diluted EPS ($USD)	-$3.18	-$3.16	-$1.93	-$1.74
G&A ($USD Millions)	$4.62	$4.32	$4.40	$4.20
R&D ($USD Millions)	$4.72	$5.32	$5.17	$5.26
Cash & Equivalents ($USD Millions)	$50.90	$54.20	$49.20	$51.18

Notes:

Revenue line not presented in company releases; KALA is a clinical-stage company with no product revenue in period (company statements list costs and other income only) .

KPIs (Clinical and Corporate)

KPI	Q2 2024	Q3 2024	Q4 2024
CHASE topline timing	Target Q1 2025	Target Q2 2025	Target Q3 2025 (extended enrollment)
Patients randomized (CHASE)	Not disclosed	Not disclosed	87
LATAM site activation	In process subject to clearance	5 sites initiated in Argentina; more in process	Sites activated in Latin America
Cash runway	Into 4Q 2025 (incl. CIRM funding)	Into 4Q 2025 (incl. CIRM)	Into 1Q 2026 (post financing, debt prepay)

Guidance Changes

Metric	Period	Previous Guidance	Current Guidance	Change
CHASE Phase 2b topline readout	2025	Q2 2025 (Nov 2024 update)	Q3 2025 (Mar 2025 update)	Lowered (timeline delay)
Cash runway	Opex funding horizon	Into 4Q 2025 (Q2/Q3 updates, incl. CIRM)	Into 1Q 2026 (post $10.75M financing; debt prepayment)	Raised (extended runway)
Trial sites (LATAM)	Enrollment footprint	Argentina sites initiated; more pending	LATAM sites activated	Expanded

No revenue, margin, or tax guidance issued; emphasis remains on clinical timelines and cash runway .

Earnings Call Themes & Trends

No Q4 2024 earnings call transcript was found; themes below synthesize 8-Ks and press releases.

Topic	Previous Mentions (Q2 & Q3 2024)	Current Period (Q4 2024)	Trend
MSC-S platform focus	Platform framed as gene-agnostic, multifactorial for ocular orphan diseases	Continued emphasis; KPI-012 central to strategy	Steady focus
KPI-012 in PCED	Topline targeted Q1→Q2 2025; enrollment ongoing	Enrollment extended; topline now Q3 2025	Slight delay, quality-first
Latin America clinical sites	Argentina sites initiated; additional pending	LATAM sites activated, expanding recruitment	Broader footprint
Regulatory path (BLA)	CHASE could be first of two pivotal trials	Reiterated contingent on positive results	Consistent
Funding/CIRM	CIRM installments (Aug $3.2M); runway into 4Q25	Runway into 1Q26 post financing, debt prepay	Improved runway
Leadership	—	CEO transition to interim CEO Bazemore	Organizational change

Management Commentary

“We are well-positioned this year to execute our clinical and strategic priorities, with KPI-012 at the center of our efforts…We now plan to report topline results in the third quarter of 2025.” — Todd Bazemore, interim CEO .
“We recently completed a $10.75 million private placement financing, which has strengthened our balance sheet and extended our cash runway into the first quarter of 2026.” — Bazemore .
“It is a privilege to continue to build on the strong foundation…towards the completion of the CHASE trial of KPI-012 in PCED and advancing this important program.” — Bazemore upon appointment .

Q&A Highlights

No Q4 2024 earnings call transcript accessible; therefore, no Q&A themes or clarifications available for this quarter [functions.ListDocuments earnings-call-transcript returned none].

Estimates Context

EPS vs consensus: S&P Global “Primary EPS” consensus for Q4 2024 was -$2.28; actual S&P “Primary EPS” recorded -$1.23, a beat of $1.05. Company-reported diluted EPS was -$1.74 (methodological differences vs S&P normalization) . Values retrieved from S&P Global*
Revenue: S&P Global consensus $0.0 for Q4 2024 (clinical-stage), consistent with company reporting of no product revenue line in releases . Values retrieved from S&P Global*

Metric	Q4 2024 Consensus	Q4 2024 Actual (S&P)	# of Estimates
Primary EPS ($USD)	-$2.28*	-$1.23*	2*
Revenue ($USD Millions)	$0.00*	N/A	2*

Note: Company-reported diluted EPS was -$1.74 .

Key Takeaways for Investors

Trial integrity prioritized over speed: enrollment extension should enhance dataset quality but delays topline to 3Q25; adjust catalyst timelines accordingly .
Balance sheet improved: $10.75M financing and debt prepayment extended runway into 1Q26, reducing near-term financing risk amid ongoing R&D .
Execution momentum: 87 randomized and LATAM activation suggest broader recruitment capacity; watch for steady enrollment updates into 2Q25 .
EPS beat vs S&P consensus underscores cost control and other income (grant) contributions; track grant inflows and expense trends for quarterly volatility . Values retrieved from S&P Global*
CEO transition places KPI-012 execution under seasoned operator; governance stability maintained with former CEO as Chair .
Regulatory narrative consistent: CHASE could serve as the first pivotal toward BLA; topline in 3Q25 is the primary stock catalyst over the next 6–9 months .
Near-term trading: shares likely sensitive to enrollment cadence, any interim operational updates, and further funding steps; medium-term thesis hinges on CHASE efficacy and regulatory dialogue .

Appendix: Source Documents

Q4 2024 8-K 2.02 and Exhibit 99.1 (press release, financial tables) .
Other Q4 2024 period press releases: CEO transition and TD Cowen presentation .
Prior quarters for trend: Q3 2024 8-K (financial tables and corporate update) ; Q2 2024 8-K (financial tables and corporate update) .

Disclaimer: S&P Global estimate values marked with an asterisk are retrieved from S&P Global and may reflect normalization methodologies that differ from company-reported GAAP metrics.

KALA BIO, Inc. (KALA)·Q4 2024 Earnings Summary