Name: Vaxxinity, Inc. Q4 2021 Earnings Call
Start: 2022-03-28T00:00:00.000Z

Executive Summary

Vaxxinity reported no revenue in Q4 2021 and a net loss of $48.2M ($0.48/share), driven by elevated G&A from IPO-related stock-based comp and ongoing R&D, with cash and equivalents at $144.9M at year-end .
Q4 OpEx showed R&D at $17.3M and G&A at $30.5M; G&A rose primarily due to $23.9M in stock-based compensation tied to performance grants earned at the IPO, a key non-cash driver of the quarter’s loss .
Pipeline execution set 2022 catalysts: UB-612 Phase 3 heterologous booster topline (2H22), UB-311 Phase 2b initiation (late 2022), UB-312 Phase 1 Part B end-of-treatment analysis (2H22), and UB-313 IND/CTA submission in 2022 .
No Wall Street consensus estimates were available via S&P Global for Q4 2021 (SPGI mapping unavailable), limiting beat/miss analysis; Vaxxinity guided cash runway into 2023, reducing near-term financing risk .

What Went Well and What Went Wrong

What Went Well
- Management highlighted a “transformational year” with IPO completion and expanded clinical programs; CEO emphasized advancing multiple pipeline programs through and into the clinic in the next 12 months .
- UB-612 booster strategy progressed to Phase 3, aiming for non-inferiority in neutralizing antibodies vs mRNA, adenovector, and inactivated platforms, with broad variant-coverage data including higher Omicron neutralizing titers vs an approved mRNA vaccine in preprint data .
- Cash balance of $144.9M at year-end (vs. $31.1M prior year) supports execution; company reiterated runway into 2023 in MD&A .
What Went Wrong
- Q4 G&A surged to $30.5M (vs. $2.8M YoY) from $23.9M in stock-based comp tied to IPO events, compressing the quarter’s P&L despite no revenue; net loss widened to $48.2M .
- TFDA denial of EUA for UB-612 in Aug 2021 (appeal ongoing) and pandemic-related trial logistics were noted in filings as headwinds to timelines and regulatory path .
- Limited commercial revenue (zero in Q4) and lack of sell-side consensus in SPGI constrained estimate comparisons and near-term revenue visibility .

Metric	Q4 2020	Q3 2021	Q4 2021
Revenue ($USD Millions)	$0.00	$0.05	$0.00
Net Loss ($USD Millions)	$(12.72)	$(30.39)	$(48.19)
Diluted EPS ($USD)	$(0.19)	$(0.44)	$(0.48)
R&D Expense ($USD Millions)	$8.46	$23.62	$17.33
G&A Expense ($USD Millions)	$2.76	$6.70	$30.52
Gross Profit ($USD Millions)	$0.00	$0.04	$0.00
Cash & Equivalents ($USD Millions, period-end)	$31.14	$89.38	$144.89
Weighted Avg Shares (Basic & Diluted)	68.19M	68.73M	100.09M

Commentary: Q4 saw YoY OpEx step-up tied to IPO-related comp and program costs; Q3-to-Q4 R&D moderated as UB-612 manufacturing/CRO costs peaked earlier in 2021 .

Metric	Period	Previous Guidance	Current Guidance	Change
UB-612 Phase 3 heterologous booster topline	2H 2022	Not previously set in PRs	Topline readout expected 2H 2022	New
UB-311 Phase 2b initiation (early AD)	Late 2022	Pre-Phase 3 meeting done; planning ongoing	Initiate Phase 2b in late 2022	Maintained/Specified
UB-312 Phase 1 Part B (PD patients) end-of-treatment analysis	2H 2022	Ongoing Part B	End-of-treatment analysis 2H 2022	Maintained
UB-313 (anti-CGRP) IND/CTA	2022	IND-enabling ongoing	Submit IND/CTA in 2022	Maintained
Anti‑PCSK9 lead selection & IND-enabling	2022	PoC in NHP planned	Select lead and initiate IND-enabling in 2022	Maintained
Financial guidance (revenue, margins, OpEx, tax, dividends)	2022	None	None provided	N/A

Topic	Previous Mentions (Q3 2021)	Current Period (Q4 2021)	Trend
R&D execution & OpEx drivers	R&D increased due to UB‑612 trial materials/manufacturing and CRO costs	R&D $17.3M; G&A surge from IPO-related stock comp; continued multi-program advancement	Elevated but normalizing vs Q3 on R&D; G&A one-time spike
COVID-19 booster strategy	Pursuing heterologous boost pathways; TFDA appeal noted	Phase 3 heterologous booster launched; topline expected 2H22	Advancing to pivotal booster data
Regulatory/legal	TFDA EUA denial (appeal) & pandemic impacts on trial logistics	Reiterated booster path; no financial guidance; focus on global regulatory paths	Ongoing regulatory engagement
Cash runway/financing	Cash $89.4M at 9/30/21; runway into 2023	Cash $144.9M at 12/31/21; runway into 2023 reaffirmed	Improved liquidity post-IPO
Internal controls/public company readiness	Material weaknesses disclosed; remediation in progress	IPO completed; added finance leadership in Jan 2022	Strengthening governance/finance

Note: No earnings call transcript was available in the document set; themes are derived from the Q4 press release and filings .

“2021 was a transformational year for Vaxxinity... We expect to demonstrate our strength of execution by meaningfully advancing multiple pipeline programs through and into the clinic” — CEO Mei Mei Hu .
UB‑612 booster strategy: “head-to-head study designed to demonstrate non‑inferior neutralizing antibodies compared to the other three platforms” with topline data in 2H 2022 .
Corporate updates: IPO closed Nov 2021; appointments announced Jan 4, 2022 (SVP Finance & Accounting; Audit Chair) supporting public company operations .

No public earnings call transcript was located; therefore, analyst Q&A themes and any intra-quarter guidance clarifications are unavailable in our source set (searched earnings-call-transcript; none found).

Wall Street consensus estimates via S&P Global were unavailable for VAXX Q4 2021 due to missing CIQ mapping (tool returned an error). As a result, we cannot provide EPS/revenue consensus or beat/miss analysis for Q4 2021. Values would normally be retrieved from S&P Global; however, estimates are not available in this case.

Liquidity runway into 2023 with $144.9M cash supports near-term execution across Alzheimer’s, Parkinson’s, migraine, COVID-19 booster, and anti‑PCSK9 programs; financing risk is reduced short term .
2022 catalysts are stock-relevant: UB‑612 Phase 3 heterologous booster topline (2H22) and UB‑311 Phase 2b initiation (late 2022) can shift sentiment; data readouts are likely the primary trading drivers .
Q4 P&L impacted by non‑cash stock‑based comp from IPO events; investors should normalize G&A for one‑offs when modeling forward OpEx .
Regulatory path remains a focus (TFDA appeal; global booster strategy); watch for updates and the quality of booster immunogenicity/variant data relative to mRNA benchmarks .
Operational readiness improving post-IPO with strengthened finance leadership and governance; remediation of disclosed internal control weaknesses should be monitored .
Lack of sell-side coverage/consensus limits estimate-based narratives; trading likely to be catalyst and liquidity driven until clinical data matures (no SPGI consensus available).