Executive Summary

Q4 2022 was dominated by the NIH‑sponsored Phase 2 topline result: bryostatin‑1 failed the primary SIB endpoint at week 28, though a severe AD subgroup showed statistical signals on several secondary endpoints; management is reassessing next steps .
Financially, Synaptogenix ended the year with $37.5M in cash, bolstered by a late‑Q4 financing; significant non‑cash gains from warrant/derivative revaluation in Q4 drove a quarterly net profit despite elevated G&A tied to stock‑based/IR expenses .
No revenue; operating model remains R&D‑only. Prior two quarters (Q2/Q3) showed rising R&D tied to the confirmatory Phase 2, with Q4 reflecting RSU vesting and warrant effects that increased G&A expense .
Catalyst: Dec 16 topline miss (primary endpoint not met) is the key stock narrative event; management emphasized cash flexibility while it evaluates the program .

What Went Well and What Went Wrong

What Went Well
- Severe AD subgroup signals: Nearly all pre‑specified secondary endpoints for MMSE 10‑14 subgroup achieved statistical significance; exploratory/post hoc analyses also positive, informing potential path forward .
- Strong year‑end liquidity: Cash and equivalents of $37.48M at Dec 31, 2022 (also disclosed as “approximately $37.5M”) provide runway while plans are reassessed .
- Q4 non‑cash gains: Decrease in fair value of warrant liability ($8.405M) and derivative liability ($1.821M) recorded in Q4 supported a quarterly net profit despite higher operating expenses .
What Went Wrong
- Primary endpoint miss: Phase 2 primary endpoint (change in SIB at week 28) was not met (Bryostatin +1.4 vs placebo +0.6; not statistically significant), increasing clinical and regulatory uncertainty .
- Elevated G&A in Q4: Full‑year G&A was $9.81M, implying a sizable Q4 step‑up from stock‑based comp and IR costs (see financial table) .
- Controls/governance concerns: Management disclosed material weaknesses in disclosure controls in Q2 and Q3; the board also reduced stockholder meeting quorum to one‑third late in Q4 .

Financial Results

Note: Synaptogenix has no revenue. Q4 2022 values are calculated as FY 2022 minus 9M 2022 (see sources). All amounts USD.

Metric	Q2 2022	Q3 2022	Q4 2022
Revenues ($)	$0 (“no revenues” for period)	$0 (“no revenues” for period)	$0 (FY shows $—)
Research & Development Expense ($)	$1,941,101	$1,484,694	$1,413,059 (FY $6,324,928 − 9M $4,911,869)
General & Administrative Expense ($)	$1,855,290	$1,682,512	$4,475,808 (FY $9,810,068 − 9M $5,334,260)
Total Operating Expenses ($)	$3,796,391	$3,167,206	$5,888,867 (FY $16,134,996 − 9M $10,246,129)
Other Income (Expense), net ($)	$44,487 (interest)	$140,730 (interest)	$10,371,212 (FY $10,561,039 − 9M $189,827)
Net Income (Loss) ($)	$(3,751,904)	$(3,026,476)	$4,482,345 (FY $(5,573,957) − 9M $(10,056,302))
Basic & Diluted EPS ($)	$(0.54)	$(0.43)	Not disclosed (quarterly EPS not provided)
Cash & Equivalents (period end) ($)	$28,754,621	$26,334,137	$37,478,480

Margins

Net Income Margin %: Not applicable (no revenue) .

Guidance Changes

Metric	Period	Previous Guidance	Current Guidance	Change
Financial guidance	FY/Q4 2022	None	None	Maintained (no formal guidance)

Earnings Call Themes & Trends

Note: No call transcript located; themes below reflect company filings/press releases.

Topic	Previous Mentions (Q2 2022)	Previous Mentions (Q3 2022)	Current Period (Q4 2022)	Trend
Phase 2 AD program	Active confirmatory Phase 2; R&D up 60% YTD; NIH grant maxed	Trial activity ongoing; cumulative WCT costs ~$10.3M	Topline miss on primary endpoint; severe subgroup signals; evaluating next steps	From execution to reassessment
Cash runway/liquidity	~$27.4M expected sufficient ≥12 months from Q2 filing	~$25.7M expected sufficient ≥12 months from Q3 filing	$37.5M cash at year‑end; financing closed in Q4	Improved
Internal controls	Material weaknesses disclosed	Material weaknesses continued	No update in year‑end 8‑K; remained a known issue for 2022	Persistent risk
Investor relations spend	Moderate	IR spend rose; RSU vesting timing disclosed	Higher G&A in Q4 implied by FY vs 9M	Elevated
Pipeline expansion (Fragile X/MS)	Planning; collaborations (Nemours/Cleveland Clinic)	Planning/agreements continue	IND for Fragile X on hold; evaluating plans; MS collaboration noted in 10‑K	Cautious/ongoing

Management Commentary

“We are disappointed in the topline results from this Phase 2 trial… we are conducting a full review of all of the trial data to determine potential next steps… our substantial balance sheet offers us flexibility as we determine the next steps forward.” – CEO Alan Tuchman, M.D. .
Company statement on severe subgroup: “Nearly all pre‑specified secondary endpoints in the most advanced and severe AD (MMSE 10‑14) patient population were achieved with statistical significance… Data also showed statistical significance in exploratory secondary endpoints… post hoc analysis was positive.” .

Q&A Highlights

Not applicable; no Q4 2022 earnings call transcript cited in company filings. Primary public communications were the Dec 16 topline press release and the FY 2022 10‑K .

Estimates Context

Wall Street consensus (S&P Global) for revenue/EPS was not available for SNPX. Synaptogenix is pre‑revenue and not broadly covered by sell‑side; therefore, no estimate vs. actual comparison can be made for Q4 2022.

Key Takeaways for Investors

The Dec 16 topline miss is the key narrative driver; however, severe‑subgroup signals and exploratory/post hoc positives provide optionality for a refined clinical path (e.g., enriched populations, endpoints) .
Balance sheet strength ($37.5M cash) and Q4 non‑cash gains provide time to reassess the AD program and consider parallel orphan/adjacent indications (Fragile X/MS), but external funding or partnerships will likely be needed to reach pivotal work .
Operating profile remains pre‑revenue; quarterly P&L is dominated by R&D cadence and non‑cash fair‑value remeasurements, creating volatility (Q4 net profit vs. Q2/Q3 losses) .
Elevated Q4 G&A (stock‑based comp/IR) underscores cost‑discipline focus ahead of program decisions; monitoring 2023 expense normalization is important .
Persistent internal control weaknesses and governance changes (reduced quorum) warrant continued attention to corporate process/oversight as the company evaluates strategic alternatives .
Near‑term trading likely tracks program updates (FDA interactions, study design pivots, subgroup strategy); medium‑term thesis hinges on translating subgroup signals into a registrationally credible plan while preserving cash runway .

Supporting sources: Phase 2 topline press release ; FY 2022 10‑K (financials, subgroup analyses, liquidity) ; Q3 2022 10‑Q (quarterly P&L, liquidity, IR spend) ; Q2 2022 10‑Q (quarterly P&L, liquidity) ; 8‑K bylaw/quorum change .

Synaptogenix, Inc. (SNPX)·Q4 2022 Earnings Summary