Executive Summary

Q1 2023 delivered higher grant revenue ($0.118M) and a wider net loss ($1.068M) as public-company G&A costs ramped; diluted EPS was $(0.19) versus $(0.19) in Q1 2022 .
Positive clinical catalysts: LP-10 Phase 2a top-line results were presented at AUA; Company plans an FDA Type B meeting and executed a manufacturing collaboration with Cook MyoSite ahead of IND .
Liquidity: Cash was $4.019M at quarter-end; management reiterated cash runway into 2024 .
No earnings call transcript was available for Q1 2023; estimate comparisons are not presented due to S&P Global consensus unavailability for this issuer in the period.

What Went Well and What Went Wrong

LP-10 Phase 2a top-line results: “Lipella has had a strong start to 2023 with the release of positive top line results from our Phase 2a clinical trial evaluating the safety and efficacy of LP-10 as a treatment for hemorrhagic cystitis” .
Execution toward regulatory path: “We expect to schedule a Type B meeting with the FDA regarding this program in the coming months” .
CMC readiness: Manufacturing collaboration with Cook MyoSite “in anticipation of Lipella’s forthcoming Investigational New Drug (IND) application” .

Loss widened YoY as public company costs ramped: Net loss increased to $(1.068)M; G&A rose to $0.509M (+$0.415M YoY) largely due to public company costs, D&O insurance, investor relations, and professional fees .
Going-concern emphasis: Management disclosed substantial doubt about continuation absent additional capital, despite cash runway into 2024 .
Operating cash burn increased: Net cash used in operating activities was $(1.078)M vs $(0.699)M in Q1 2022, reflecting higher operating spend .

Metric	Q1 2022	Q1 2023
Revenue ($USD Millions)	$0.033	$0.118
Net Loss ($USD Millions)	$(0.738)	$(1.068)
Diluted EPS ($USD)	$(0.19)	$(0.19)
Net Income Margin %	(2,226%)	(905%)
Cash and Equivalents ($USD Millions)	$0.414	$4.019

Operating expenses and KPIs:

KPI	Q1 2022	Q1 2023
R&D Expense ($USD Thousands)	$676	$694
G&A Expense ($USD Thousands)	$94	$509
Net Cash Used in Operating Activities ($USD Thousands)	$(699)	$(1,078)
Weighted Avg Shares (Basic/Diluted)	3,866,625	5,743,945
NIH Grant Revenue Recognized ($USD Thousands)	$33	$118
Expected NIH Grant Receipts in 2023 ($USD Thousands)	—	~$500

Segment breakdown: Not applicable (single clinical-stage platform focus) .

Metric	Period	Previous Guidance	Current Guidance	Change
Cash Runway	Into 2024	“We anticipate this will provide Lipella with an operating runway into 2024.” (Mar 31, 2023 PR)	“Existing cash and cash equivalents will be sufficient to fund operations and capital expenses into 2024.” (10-Q)	Maintained
LP-10 Regulatory Interactions	2023	Expect to meet with FDA to discuss Phase 2a results and regulatory pathway (FY22 PR)	Expect to schedule FDA Type B meeting “in the coming months” (Q1 PR)	Clarified timing
LP-310 IND Timing	3Q 2023	Oral Health SAB established to guide LP-310 development (Q1 PR)	Intend to submit IND in 3Q 2023 (10-Q)	New specific timing

No revenue/EPS/margins/OpEx numeric guidance provided; dividends not applicable .

Topic	Previous Mentions (Q-2 and Q-1)	Current Period (Q1 2023)	Trend
LP-10 clinical progress	Successful completion of Phase 2a; planned AUA presentation (FY22 PR, Mar 31)	Positive Phase 2a top-line; late-breaking AUA presentation; planning FDA Type B meeting	Advancing toward FDA engagement
Manufacturing/CMC	—	Collaboration with Cook MyoSite to facilitate CMC for LP-10 ahead of IND	Building CMC readiness
LP-310 program	Oral Health SAB created to focus LP-310 (FY22 PR)	SAB in place; IND targeted for 3Q 2023	Program maturation toward IND
Liquidity/runway	Year-end cash $5.1M; runway into 2024 (FY22 PR)	Cash $4.019M; runway into 2024 re-affirmed; going-concern risk if capital not raised	Stable runway with risk disclosure
Public company transition	IPO completed in Dec 2022 (FY22 PR)	Higher G&A driven by public company costs (D&O, IR, professional fees)	Cost structure reset post-IPO

Note: No Q1 2023 earnings call transcript available in filings.

“Lipella has had a strong start to 2023 with the release of positive top line results from our Phase 2a clinical trial evaluating the safety and efficacy of LP-10 as a treatment for hemorrhagic cystitis… We expect to schedule a Type B meeting with the FDA regarding this program in the coming months.” — Dr. Jonathan Kaufman, CEO .
“Following our IPO and other initial expenses, we ended the year with $5.1 million in cash. We anticipate this will provide Lipella with an operating runway into 2024.” — Dr. Jonathan Kaufman, CEO .
“Looking ahead… We expect to meet with the FDA to discuss the results of our Phase 2a clinical study… We established an Oral Health Scientific Advisory Board… [to] guide us in the development of LP-310.” — Dr. Michael Chancellor, CMO .

No Q1 2023 earnings call transcript was available in the company’s filings set; therefore, no Q&A highlights can be provided.

Wall Street consensus estimates via S&P Global were not available for LIPO for Q1 2023; estimate comparisons are therefore not presented.

Clinical momentum is the primary catalyst: LP-10’s positive Phase 2a readout and an anticipated FDA Type B meeting could drive binary event risk around regulatory feedback .
Liquidity provides near-term operating runway into 2024, but explicit going-concern language underscores the need for external funding; watch capital markets strategy, potential partnerships, or non-dilutive grants .
Operating cash burn increased with public company costs; expect G&A to remain elevated relative to historical private-company levels, affecting near-term loss trajectory .
LP-310 is progressing toward IND in 3Q 2023, adding a second program with potential incremental catalysts in oral lichen planus .
Near-term trading set-up: stock likely reacts more to clinical/regulatory headlines (AUA, FDA meeting scheduling/feedback, IND submissions) than to quarterly grant revenue variations .
Medium-term thesis: value inflection depends on LP-10 regulatory pathway clarity and financing strategy to sustain development; monitor manufacturing readiness via Cook MyoSite collaboration and any guidance updates .
With no consensus coverage and limited revenue, frame performance around milestone achievement, liquidity runway, and burn discipline rather than quarterly beats/misses.

Sources: Q1 2023 press release (8-K 2.02) ; Q1 2023 10-Q financial statements and MD&A ; FY22 business update press release (8-K 2.02) .