Executive Summary

Q1 FY2025 delivered $1.00M collaboration revenue from the Alkem licensing agreement, versus $0.02M in the prior-year quarter; net loss widened to $3.16M with EPS of $(1.56) on higher R&D and G&A tied to program and licensing activity .
Clinical update: SB101 monotherapy completed dose escalation at MTD 1200 ng/kg; 48% of evaluable monotherapy patients achieved stable disease at 4 months and one PR with a 45% tumor reduction; combinations with atezolizumab (PROC) and trabectedin (STS) are advancing on schedule .
Liquidity: Cash ended at $4.86M; company now expects runway into July 2025 and received preliminary approval to sell up to $0.8M of NJ NOLs, but continues to flag going-concern risk absent additional financing .
Leadership updates: CBO appointment (Stephen McAndrew) and CFO transition (Donald Griffith replacing Jay Cross) sharpen focus on BD and capital discipline; management reiterated 2025 clinical milestones as potential stock catalysts (H1 efficacy, H2 safety/RP2D) .

What Went Well and What Went Wrong

What Went Well

SB101 monotherapy showed clinical benefit with 48% stable disease at 4 months and one partial response with a 45% tumor size reduction at the highest dose; “established clinical benefit” showcases FHAB platform potential .
Program execution milestones on track: additional safety update for SB221 in Q1 CY2025; topline efficacy (SB101) in H1 CY2025; STS trabectedin combo safety in H2 CY2025 .
IP and partnering momentum: EU patent EP3583125 B1 granted; Alkem license delivered $1.0M upfront revenue and an unbilled $0.5M contract asset, validating SON-080 monetization path .

What Went Wrong

Operating expenses increased versus prior year due to reversal of accrued bonuses in the base period and legal/consulting tied to Alkem; net loss widened to $3.16M and EPS deteriorated to $(1.56) YoY .
Liquidity remains constrained with runway only into July 2025 and explicit going-concern language; incremental financing or partnerships are required to sustain pipeline development .
Prior consensus estimates not available; inability to benchmark “beats/misses” versus Street limits near-term narrative alignment for public-market investors (S&P Global estimates unavailable at time of writing) [GetEstimates error].

Financial Results

Core P&L and Liquidity (USD)

Metric	Q1 FY2024 (Dec 31, 2023)	Q3 FY2024 (Jun 30, 2024)	Q1 FY2025 (Dec 31, 2024)
Revenue ($USD Millions)	$0.019	$0.000	$1.000
Net Loss ($USD Millions)	$1.169	$3.506	$3.161
Diluted EPS ($USD)	$(2.46)	$(0.70)	$(1.56)
Cash and Equivalents ($USD Millions)	$3.021	$3.554	$4.862

Notes:

Revenue YoY increase driven by Alkem Agreement ($1.0M point-in-time recognition upon license/supply transfer) .
Cash improved sequentially due to November/December equity/warrant financings (~$7.7M net in Q1) .

Margins

Metric	Q1 FY2024	Q3 FY2024	Q1 FY2025
Net Income Margin %	NM (loss on $0.019M revenue)	NM (loss, no revenue)	NM (loss on $1.000M revenue)

NM = Not meaningful given early-stage profile, small revenue base, and negative net income .

KPIs and Program Metrics

KPI	Q1 FY2024	Q4 FY2024	Q1 FY2025
SB101 Safety/MTD	Dose escalation ongoing	MTD established at 1200 ng/kg; 24 subjects enrolled	No DLTs; mild/transient AEs; no CRS
SB101 Clinical Benefit (Monotherapy)	35% SD at 4 months across studies (preliminary)	Completed monotherapy escalation	48% SD at 4 months (10/21 evaluable); one PR (45% reduction)
SB221 (Atezolizumab combo)	Enrollment ongoing	MTD integrated; safety update expected Q1 CY2025	Additional safety data expected Q1 CY2025
STS (Trabectedin combo)	N/A	Expansion planning	Enrollment underway; topline safety H2 CY2025
SON-1210	Toxicology complete; collaboration set	SOC collaboration; IND prep	IND submission planned Q1 CY2025
SON-080	CIPN Phase 1b data supportive	India DPN license signed (Alkem)	DPN Phase 2 initiation H2 CY2025
Cash Runway	N/A	Into July 2025 (with NOL sale process)	Into July 2025; prelim NJ NOL sale approval up to $0.8M

Guidance Changes

Metric	Period	Previous Guidance	Current Guidance	Change
SB101 Monotherapy Topline Efficacy	H1 CY2025	H1 CY2025	H1 CY2025	Maintained
SB221 (Atezolizumab) Safety Update	Q1 CY2025	Q1 CY2025	Q1 CY2025	Maintained
SB221 RP2D & Topline Efficacy	H2 CY2025	H2 CY2025	H2 CY2025	Maintained
STS (Trabectedin) Topline Safety	H2 CY2025	New cohort expansion noted	H2 CY2025	Raised specificity (timeline formalized)
SON-1210 IND Submission	Q1 CY2025	Q1 CY2025	Q1 CY2025	Maintained
SON-080 DPN Phase 2 Initiation	H2 CY2025	Seeking partner; DPN plan	H2 CY2025 (Alkem)	Firmed (via license)
Cash Runway	Through mid-2025	Into July 2025 (FY release)	Into July 2025; prelim NJ NOL sale approval	Maintained; financing path detailed

Earnings Call Themes & Trends

Note: No Q1 FY2025 earnings call transcript was filed; themes based on 8-K, 10-Q, and press releases.

Topic	Previous Mentions (Q3 FY2024, Q4 FY2024)	Current Period (Q1 FY2025)	Trend
Clinical Efficacy (SON-1010)	35% SD at 4 months across studies; dose escalation ongoing	48% SD at 4 months; PR with 45% reduction; MTD set at 1200 ng/kg	Improving
Safety Profile (IL-12 FHAB)	No DLTs; favorable safety	No DLTs/SAEs related; transient mild AEs; no CRS	Maintained
Combinations (Atezolizumab/Trabectedin)	SB221 expanded to include MTD; new trabectedin cohort outlined	SB221 safety update imminent; STS enrollment underway	Advancing
IP Positioning	US patent for SON-1210; platform patents	EU patent EP3583125 B1 granted	Strengthening
Partnering/Monetization	Pursuing SON-080 partner	Alkem executed; $1.0M upfront recognized	De-risked
Capital & Runway	Equity raises; runway commentary	Nov/Dec offerings; runway into July 2025; NOL sale prelim approval	Stabilized near-term

Management Commentary

“We have made strides in our Phase 1 SB101 trial with established clinical benefit including a 45% reduction in tumor size by RECIST criteria indicating a partial response and demonstrating the effectiveness of our FHAB platform… potentially catalytic milestones… key clinical data readouts” — Pankaj Mohan, Ph.D., Founder & CEO .
“Combining trabectedin with SON-1010 has the potential for a natural synergistic effect… we believe a large unmet need remains for STS” — Dr. Sant Chawla, Principal Investigator (SOC) .
“Assess earlier-stage patients… potential for SON-1010 to turn ‘cold’ tumors ‘hot’” — Richard Kenney, M.D., CMO .
Leadership/BD focus: Appointment of Stephen J. McAndrew as Chief Business Officer to drive partnering strategy and valuation of FHAB assets .

Q&A Highlights

No Q1 FY2025 earnings call transcript was available; no Q&A highlights or guidance clarifications were published in filed materials [ListDocuments earnings-call-transcript: none].

Estimates Context

Wall Street consensus (S&P Global) for Q1 FY2025 EPS/Revenue was unavailable at time of writing due to access limitations; as a result, beats/misses versus Street cannot be assessed from primary data [GetEstimates error].

Metric	Q1 FY2025 Consensus	Actual
Revenue ($USD Millions)	Unavailable (S&P Global)	$1.000
Primary EPS ($USD)	Unavailable (S&P Global)	$(1.56)

Key Takeaways for Investors

Increasing evidence of SON-1010 clinical activity (48% SD at 4 months; PR at MTD) with favorable safety and mechanistic rationale supports near-term readouts as potential stock catalysts (H1 efficacy; Q1 safety; H2 RP2D/safety) .
Combination strategies (atezolizumab in PROC; trabectedin in STS) are progressing and expand addressable patient cohorts; successful safety and early efficacy could unlock partnership optionality and de-risk the program .
Liquidity improved but remains tight: $4.86M cash, runway into July 2025, preliminary NJ NOL sale approval; continued capital markets usage (ChEF) or BD milestones will be needed to bridge to data inflections and reduce going-concern risk .
Monetization proof point: Alkem license generated $1.0M upfront revenue and establishes a path to milestones/royalties in DPN, underscoring platform value beyond oncology .
Leadership transitions (CBO appointment, CFO change) aim to accelerate BD execution and cost vigilance into key 2025 timelines; watch for incremental updates and potential BD announcements .
Near-term trading: sensitive to clinical safety updates (SB221 Q1), any early STS enrollment/safety progress, and financing headlines; medium-term thesis hinges on demonstrating translational efficacy (H1/H2 readouts) and securing strategic capital .
Risk framework: going-concern language, financing dependence, and absence of Street consensus visibility heighten volatility until data and capital milestones arrive .

Appendix: Financing and Runway Details

Q1 cash flow benefited from registered direct/PIPE and November public offering (~$7.7M net), raising quarter-end cash to $4.86M; facility capacity remains ($24.9M available under ChEF) .
Company expects runway into July 2025 and is pursuing NOL monetization (~$0.8M prelim approval) and additional capital sources; explicit going-concern disclosure remains in 10-Q .

Sonnet BioTherapeutics Holdings, Inc. (SONN)·Q1 2025 Earnings Summary