Name: KALA BIO, Inc. Q1 2025 Earnings Call
Start: 2025-05-14T00:00:00.000Z

Executive Summary

KALA reported a smaller year-over-year net loss and lower operating expenses, with Q1 2025 net loss of $8.95M ($1.41 per share) vs. $11.81M ($4.20 per share) in Q1 2024, aided by $2.35M in grant income .
EPS beat Wall Street consensus: reported EPS of -$1.41 vs. S&P Global consensus of -$2.03*, a positive surprise of ~$0.62 per share; revenue remained non-commercial (consensus $0.0*) .
CHASE Phase 2b topline timing was reaffirmed for 3Q 2025 (a delay from 2Q 2025 indicated last fall), with 87 patients randomized by FY24 and Latin America sites activated, making the upcoming readout the key stock catalyst .
Cash was $42.2M as of March 31, 2025, with runway into Q1 2026 maintained; debt profile shifted with current portion rising to $15.5M, which investors should watch into the data readout .

What Went Well and What Went Wrong

Operational execution supported by grant income: “Grant income” of $2.35M in Q1 2025 helped offset expenses and narrow the net loss vs. prior year .
Pipeline momentum: “We are targeting to report topline results from the Phase 2b CHASE trial of KPI-012 in the third quarter of this year,” said interim CEO Todd Bazemore, underscoring confidence in KPI-012’s multifactorial mechanism for PCED .
Cost discipline: G&A fell to $4.59M (from $5.42M YoY) and R&D to $6.06M (from $6.35M YoY), lowering total operating expenses to $10.67M from $11.93M YoY .

Timeline slippage vs. last fall: CHASE topline moved from “expected in 2Q 2025” (Nov-2024) to “3Q 2025” (Mar-2025; reaffirmed May-2025), reflecting enrollment adjustments and verification by a central reading center .
Sequential operating loss widened q/q: Q1 2025 operating loss of $10.67M vs. $9.46M in Q4 2024, as grant income and interest shifts only partially offset higher operating loss q/q .
Debt cadence: Current portion of long-term debt rose to $15.50M at 3/31/25 from $10.34M at 12/31/24, elevating short-term obligations ahead of the pivotal data readout .

Metric (USD, thousands unless noted)	Q3 2024	Q4 2024	Q1 2025
General & Administrative	$4,400	$4,201	$4,593
Research & Development	$5,168	$5,258	$6,055
Total Operating Expenses	$9,988	$9,459	$10,669
Loss from Operations	$(9,988)	$(9,459)	$(10,669)
Interest Income	$570	$478	$463
Interest Expense	$(1,478)	$(1,392)	$(1,091)
Grant Income	$1,946	$2,198	$2,350
Total Other Income (Expense)	$1,038	$1,284	$1,722
Net Loss	$(8,950)	$(8,175)	$(8,947)
EPS (basic & diluted)	$(1.93)	$(1.74)	$(1.41)
Weighted Avg Shares	4,627,578	4,694,611	6,345,869

Metric (USD, thousands)	Sep 30, 2024	Dec 31, 2024	Mar 31, 2025
Cash & Cash Equivalents	$49,202	$51,181	$42,222
Total Assets	$54,079	$55,483	$48,252
Working Capital	$27,412	$35,841	$22,742
Current Portion of LT Debt	$17,977	$10,336	$15,503
LT Debt (net of discounts)	$17,162	$20,102	$15,121
Other LT Liabilities	$6,191	$6,093	$4,448
Stockholders’ Equity	$6,859	$12,332	$5,708

Metric	Q1 2025 Actual	Q1 2025 Consensus
EPS ($)	$(1.41)	$(2.03)*
Revenue ($)	N/A (no commercial revenue reported)	$0.0*
Values retrieved from S&P Global.*

Metric	Period	Previous Guidance	Current Guidance	Change
CHASE Phase 2b topline timing	Clinical	“Expected 2Q 2025” (Nov-2024)	“Anticipated 3Q 2025” (Mar-2025; reaffirmed May-2025)	Delayed
Cash runway	Through	Into Q1 2026 (as of 12/31/24)	Into Q1 2026 (as of 3/31/25)	Maintained
Clinical sites	Geographies	Initiated 5 sites in Argentina; more LATAM pending (Nov-2024)	LATAM sites activated (Mar/May-2025)	Expanded

Note: No Q1 2025 earnings call transcript was available in our document catalog.

Topic	Q3 2024 Mentions	Q4 2024 Mentions	Q1 2025 Mentions	Trend
R&D execution (CHASE trial)	Focus on enrollment; 2Q25 topline target	87 patients randomized; timeline updated to 3Q25	Ongoing enrollment; 3Q25 topline reaffirmed; LATAM sites active	Delayed then stable
Regulatory strategy	Potential for CHASE to be first of two pivotal trials	Same positioning; BLA pathway reiterated	Pivotal potential reiterated; BLA support contingent on results	Consistent
Geographic expansion	Argentina sites initiated; broader LATAM pending	LATAM activation	LATAM sites activated	Expanding
Funding/grants	CIRM award funds in 3Q24; grant income in P&L	Capital raise; grant income continues	Grant income $2.35M in Q1	Supportive
Leadership changes	—	—	CEO transition (Bazemore named interim CEO; Iwicki remains Chair)	Stable leadership shift
Platform expansion (LSCD, KPI-014)	LSCD exploration; retinal preclinical plans	LSCD and retinal programs reiterated	LSCD potential reiterated; KPI-014 preclinical highlighted	Consistent

“We are targeting to report topline results from the Phase 2b CHASE trial of KPI-012 in the third quarter of this year…” — Todd Bazemore, interim CEO .
“KPI-012 has potential to be the first therapy that can address all underlying etiologies of PCED…” — Todd Bazemore .
“We have now randomized 87 patients… we have decided to extend enrollment… we now plan to report topline results in the third quarter of 2025.” — Todd Bazemore (Q4/FY press release) .

No Q1 2025 earnings call transcript was found in our catalog; consequently, no public Q&A themes or clarifications were available to analyze [ListDocuments result: 0].

Consensus EPS for Q1 2025 was -$2.03*, with 2 estimates; reported EPS was -$1.41, a beat likely driven by lower operating expenses and $2.35M grant income supporting other income .
Consensus revenue was $0.0* (non-commercial stage); the company did not report product revenue .
Values retrieved from S&P Global.*

The 3Q25 topline CHASE readout is the primary near-term catalyst; successful data could position KPI-012 as the first therapy addressing all PCED etiologies and potentially serve as one of two pivotal trials for a BLA .
EPS beat consensus in Q1 2025, with improved YoY net loss; watch sequential opex and operating loss trends as R&D scales into data readout .
Cash runway into Q1 2026 provides adequate capital through the topline; however, the rise in current debt obligations ($15.5M) merits monitoring of financing cadence and covenant requirements .
Latin America site activation broadens trial footprint and may support enrollment robustness; prior adjustments tied to central reading center underscore trial-operational rigor .
Leadership transition to interim CEO Todd Bazemore aligns with execution focus into CHASE topline; strategic continuity maintained with Iwicki as Chair .
No non-GAAP metrics were presented; analysis should rely on GAAP net loss and operating loss trends, plus grant income trajectory .
If CHASE topline is positive, expect estimate revisions (timing, probability of approval, funding needs); if negative or mixed, liquidity and debt timing become central to thesis re-evaluation .