Executive Summary

Q2 2024 delivered zero revenue and a narrower net loss from continuing operations ($3.8M, $0.15/share) versus prior year, driven largely by a favorable change in fair value of warrant liability; operating expenses rose modestly on Niyad development .
Clinical execution advanced: patient screening initiated and FDA-approved expansion of NEPHRO CRRT study sites from 10 to 14, expected to expedite enrollment and completion; Breakthrough Device Designation may support a timely approval next year .
Cash and investments were $14.0M at quarter-end, down from $18.6M in Q1; management reiterated development focus with discontinued DSUVIA expenses now absent .
Organizational transition: Co-founder/CMO Dr. Pamela Palmer to retire in October; Chief Development Officer Dr. Shakil Aslam to assume CMO role, already leading NEPHRO CRRT .
Potential stock reaction catalysts: accelerated NEPHRO site activation and first-patient enrollment update (Aug 19 press release), plus clarity on top-line timing and PMA submission trajectory .

What Went Well and What Went Wrong

What Went Well

Screening initiated and site count expanded to up to 14 U.S. ICUs, improving enrollment velocity and trial completion prospects: “We…received FDA approval to increase the maximum number of study sites from 10 to 14 which we believe will help expedite completion of the study.” — CEO Vince Angotti .
Breakthrough Device Designation and short primary endpoint duration (24 hours) support potential timely approval and efficient study completion .
Net loss from continuing operations improved YoY ($3.8M vs $4.4M) primarily due to warrant liability mark-to-market; DSUVIA discontinued ops expenses absent in Q2 2024 .

What Went Wrong

Operating expenses increased YoY (GAAP $4.27M vs $4.22M; non-GAAP $4.05M vs $3.75M) tied to Niyad development costs, pressuring near-term cash burn .
Revenue was $0 in Q2 (vs $0.253M in Q2 2023; Q4 2023 revenue $0.281M), highlighting dependence on development milestones rather than commercial inflows .
Trial start-up delays earlier in 2024 prompted management to withdraw the prior top-line-by-Sept-30 guidance, with updated timing pending after enrollment begins .

Financial Results

Metric	Q2 2023	Q4 2023	Q1 2024	Q2 2024
Revenue ($USD Thousands)	$253	$281	—	$0
Operating Costs & Expenses (GAAP, $USD Thousands)	$4,222	$4,564	$4,237	$4,270
Loss from Operations ($USD Thousands)	$(3,969)	$(4,283)	$(4,237)	$(4,270)
Total Other Income (Expense) ($USD Thousands)	$(456)	$(227)	$283	$443
Net Loss from Continuing Ops ($USD Thousands)	$(4,428)	$(4,505)	$(3,954)	$(3,827)
Basic & Diluted EPS, Continuing Ops ($USD)	$(0.41)	$(0.25)	$(0.16)	$(0.15)
Non-GAAP Operating Expenses ($USD Thousands)	$3,751	$5,211	$3,935	$4,047

Balance Sheet and Liquidity

Metric	Dec 31, 2023	Mar 31, 2024	Jun 30, 2024
Cash, Cash Equivalents & Investments ($USD Thousands)	$9,381	$18,584	$14,023
Total Assets ($USD Thousands)	$20,395	$28,772	$24,856
Total Liabilities ($USD Thousands)	$6,290	$12,438	$12,126
Stockholders’ Equity ($USD Thousands)	$14,105	$16,334	$12,730

KPIs

KPI	Q2 2023	Q4 2023	Q1 2024	Q2 2024
R&D ($USD Thousands, GAAP)	$1,552	$1,769	$1,433	$1,909
SG&A ($USD Thousands, GAAP)	$2,670	$2,795	$2,804	$2,361
Stock-based Comp (Total, $USD Thousands)	$471	$311	$302	$223
Shares Used (Basic & Diluted, Thousands)	10,924	18,369	24,722	26,202

Note: Segment breakdown is not applicable; the company is focused on development-stage assets (Niyad/nafamostat) with limited revenue contribution in the periods reviewed .

Guidance Changes

Metric	Period	Previous Guidance	Current Guidance	Change
NEPHRO CRRT top-line data timing	2024	Top-line by end of Q3 2024 (Sept 30)	Guidance withdrawn; revised timing to be provided after enrollment begins	Lowered/Delayed
PMA submission timing (Niyad)	2024	PMA submission projected by end of 2024	No explicit update provided in Q2 materials	Maintained (no update)
NEPHRO CRRT study sites	Trial scope	Up to 10 U.S. sites	Up to 14 U.S. sites (FDA approved)	Raised
Cash runway to potential approval	Through Q2 2025	Committed capital expected to provide runway to potential Niyad approval in Q2 2025	No explicit update provided in Q2 materials	Maintained (no update)

Earnings Call Themes & Trends

Note: The Q2 2024 earnings call transcript could not be retrieved due to a database inconsistency; themes are inferred from management’s prepared remarks and press releases for trend continuity .

Topic	Previous Mentions (Q4 2023 and Q1 2024)	Current Period (Q2 2024)	Trend
NEPHRO CRRT study progress	First-patient enrollment expected imminently; IRB approval in place	Screening initiated at multiple sites; site count raised to 14	Accelerating
Regulatory pathway (Breakthrough/PMA)	PMA submission targeted by end of 2024; Breakthrough Designation acknowledged	Breakthrough cited as potential advantage for timely approval next year	Constructive
Trial timing guidance	Top-line by end of Q3 2024 (prior); delays acknowledged; guidance to be revised	No new top-line date; focus on expedited completion via more sites	Reset/timing TBD
Capital position/runway	$9.4M cash YE23; $26M commitments announced Jan 2024	$14.0M cash/investments at Q2; no DSUVIA expenses	Stable/monitor burn
Organization/talent	Rebrand to Talphera; new CDO joining	CMO retirement; CDO to become CMO; continuity via consulting	Transition, de-risked

Management Commentary

“We…received FDA approval to increase the maximum number of study sites from 10 to 14 which we believe will help expedite completion of the study…Breakthrough Device Designation…potentially provides an advantage for a timely approval of the product candidate next year.” — Vince Angotti, CEO .
“While the initial site activation has taken longer than expected…we expect that our previous guidance of having top-line data available by September 30 will be revised.” — Vince Angotti (Q1 commentary) .
“Pam [Dr. Palmer]…will be retiring in October…Dr. Aslam will succeed her…already making major contributions…including expediting activities with the NEPHRO study.” — Vince Angotti .
“Corporate transformation to Talphera…capital and commitments projected to support…through a potential FDA approval by the middle of next year.” — Vince Angotti .

Q&A Highlights

The company hosted its Q2 2024 call and webcast at 4:30 p.m. ET on Aug 14; replay available on investor website .
Q&A transcript was not accessible due to a database inconsistency; detailed analyst Q&A themes and clarifications cannot be provided from primary sources in this session .

Estimates Context

Wall Street consensus (S&P Global) for Q2 2024 revenue and EPS was unavailable in our system for TLPH/ACRX due to mapping/limit errors; as a result, we cannot provide an estimates comparison for this quarter. Values retrieved from S&P Global were unavailable.
Given limited sell-side coverage and the development-stage profile, near-term estimate revisions will likely hinge on NEPHRO enrollment pace and top-line timing updates rather than financial metrics.

Key Takeaways for Investors

Execution improved: screening began and sites expanded to 14, positioning the registrational NEPHRO CRRT study for faster enrollment and completion .
Timelines reset: prior top-line-by-Sept-30 guidance withdrawn; look for updated timing once enrollment cadence is established—this is the next major catalyst .
Cash/investments at $14.0M and non-GAAP OpEx of $4.05M in Q2 imply continued focus on disciplined spend amid Niyad development; monitor burn and potential financing milestones tied to trial data .
Net loss improved YoY due to warrant liability fair value change; however, operating loss remains steady with R&D investment rising for Niyad .
Organizational transition (CMO) appears de-risked with continuity through consulting; Dr. Aslam’s leadership of NEPHRO is already in place .
Regulatory positioning remains favorable (Breakthrough Designation, short primary endpoint), supporting a potential timely approval next year if data are positive .
Near-term trading implications: updates on enrollment pace, first-patient milestones (confirmed Aug 19), and any new top-line/PMA timing will likely drive sentiment and stock reaction .

TALPHERA, INC. (ACRX)·Q2 2024 Earnings Summary