Executive Summary

NexImmune announced a strategic pivot to focus internal resources on its AIM Direct Injection (AIM INJ) “off‑the‑shelf” platform, pausing its AIM ACT clinical programs (NEXI‑001 AML, deferring NEXI‑003 HPV initiation, NEXI‑002 remains paused) to extend runway and concentrate on preclinical data generation .
Cash, cash equivalents and marketable securities were $45.9M at 9/30/22 (vs. $53.1M at 6/30/22), and management now expects runway “through the third quarter of 2023,” extended by a ~30% workforce reduction and expense realignment .
Q3 GAAP net loss was $14.7M (EPS $(0.60)), essentially flat YoY (Q3’21 loss $14.6M, EPS $(0.65)) and improved sequentially vs. Q2 (loss $15.9M, EPS $(0.69)) as G&A declined and interest income increased with higher rates .
No Wall Street consensus (S&P Global) estimates were available for NEXI; “vs. estimates” comparisons are not applicable this quarter (S&P Global consensus unavailable).

What Went Well and What Went Wrong

What Went Well
- Runway extended: guidance moved from “into Q2’23” (Q2 update) to “through Q3’23” alongside a 30% headcount reduction and cost realignment to the AIM INJ platform .
- Strategic clarity: “We have decided that the best path forward…is to realign internal resources to focus on advancing our AIM INJ ‘off‑the‑shelf’ platform,” CEO Kristi Jones said, citing disruptive potential and encouraging preclinical signals in oncology and autoimmune diseases .
- Operating discipline: G&A declined YoY in Q3 ($3.7M vs. $4.2M), and interest income rose with the rate environment, supporting a sequential improvement in EPS vs. Q2 .
What Went Wrong
- Clinical pauses: Enrollment in NEXI‑001 will be paused after dosing/follow‑up for those enrolled; NEXI‑003 initiation deferred; NEXI‑002 remains paused—implying clinical timeline delays and potential de‑risking needs via external partners .
- Continued cash burn: Cash and marketable securities fell to $45.9M at 9/30/22 from $53.1M at 6/30/22 and $65.0M at 3/31/22 despite cost controls .
- Restructuring costs: Company expects about $0.7M of severance/termination benefits in Q4 tied to the ~30% workforce reduction, adding near‑term P&L pressure .

Financial Results

Metric	Q3 2021	Q1 2022	Q2 2022	Q3 2022
Revenue ($M)	$0.0	$0.0	$0.0	$0.0
R&D Expense ($M)	$11.3	$10.4	$11.8	$11.1
G&A Expense ($M)	$4.2	$4.6	$4.1	$3.7
Total OpEx ($M)	$15.5	$15.1	$15.9	$14.9
Net Loss ($M)	$(14.65)	$(15.02)	$(15.86)	$(14.73)
Basic & Diluted EPS ($)	$(0.65)	$(0.66)	$(0.69)	$(0.60)
Cash, Equivalents & Marketable Securities ($M, period end)	—	$65.0 (3/31/22)	$53.1 (6/30/22)	$45.9 (9/30/22)
Shares Out (Wtd Avg, M)	22.65	22.84	22.87	24.41

Notes:

No S&P Global consensus for revenue/EPS; “vs. estimates” not applicable this quarter.
No revenue reported; margins such as gross/operating not meaningful given zero revenue .

KPIs and Operating Items

Workforce: 74 FTEs as of 9/30/22; plan to reduce to ~50 FTEs (≈30%) under the realignment .
Restructuring: ≈$0.7M severance/termination benefits expected, mostly in Q4’22 .
Cash runway: “through Q3 2023” based on current plans post‑restructuring .

Guidance Changes

Metric	Period	Previous Guidance	Current Guidance	Change
Cash Runway	Through 2023	Into Q2 2023 (as of Q2 update)	Through Q3 2023	Extended ~1 quarter
NEXI‑001 (AML)	Near‑term clinical ops	Enrolling; update expected 4Q22	Pause enrollment; continue dosing/follow‑up of currently enrolled; data expected Q1 2023	Paused enrollment; data timing set
NEXI‑003 (HPV)	Initiation timing	IND cleared; initiate by YE22	Not initiating at this time; explore external development; pivot HPV strategy to AIM INJ	Initiation deferred; external path
NEXI‑002 (MM)	Status	Paused enrollment; potential future shift to earlier disease	Remains paused	Unchanged (paused)
Operating Expenses/Workforce	2H22/Q4’22	—	~30% headcount reduction; ≈$0.7M restructuring costs, majority in Q4’22	New restructuring actions

Earnings Call Themes & Trends

Note: No Q3’22 earnings call transcript was located; themes reflect quarterly 8‑K press releases.

Topic	Q1 2022 Mentions	Q2 2022 Mentions	Q3 2022 Current Period	Trend
AIM INJ platform (off‑the‑shelf)	IND‑enabling work progressing; preclinical updates planned 2H22	IND‑enabling progressing; plans to report additional preclinical/IND‑enabling data in 2H22	Strategic pivot to prioritize AIM INJ; focus on preclinical data in oncology/autoimmune; “IND engine” emphasized	Increasing strategic focus
NEXI‑001 (AML)	Enrolling; robust immune responses; update in 2H22	Enrolling dose level 4; update expected 4Q22; well‑tolerated	Pause enrollment; continue dosing/follow‑up; data expected Q1 2023	Deprioritized internally; timeline shift
NEXI‑003 (HPV)	IND planned 1H22; nanoparticles manufactured	IND cleared; initiate study by YE22	Not initiating; explore external development; build HPV strategy via AIM INJ	Deferral; modality shift
NEXI‑002 (MM)	Expansion ongoing; signals of activity; well‑tolerated	Enrollment paused; consider earlier disease later	Remains paused	Paused
Cash runway	—	Into Q2 2023	Through Q3 2023 after realignment	Improved runway
Cost actions	—	Resource prioritization to lead programs	~30% workforce reduction; restructuring costs ~$.7M	Aggressive cost control

Management Commentary

“We have decided that the best path forward for NexImmune is to realign internal resources to focus on advancing our AIM INJ ‘off‑the‑shelf’ platform…We believe that the AIM INJ therapeutic modality offers the most disruptive potential to benefit patients…and the greatest potential to create long‑term value for our shareholders.” – Kristi Jones, CEO .
“Our AIM ACT cell therapy product candidates…continue to show clinical activity…While we will be pausing our cell therapy clinical trials, we are exploring external opportunities with academic centers and corporate collaborators…We will retain the internal expertise and core capabilities which will be fully leveraged…regardless of modality.” – Kristi Jones, CEO .

Q&A Highlights

No earnings call transcript was available for Q3 2022; management commentary above is drawn from the 8‑K press release. No Q&A clarifications were disclosed in primary documents reviewed .

Estimates Context

Wall Street consensus (S&P Global) for Q3’22 revenue/EPS was unavailable for NEXI; thus, no “vs. estimates” comparisons are presented this quarter (S&P Global consensus unavailable).

Key Takeaways for Investors

Strategic pivot concentrates capital on AIM INJ, an “off‑the‑shelf” modality with broader potential and faster paths to clinic, while pausing cash‑intensive AIM ACT trials—supporting runway extension to Q3’23 .
Operational discipline evident: ~~30% headcount reduction and lower G&A YoY; restructuring charges (~~$0.7M) mainly in Q4 are manageable relative to quarterly burn .
Clinical timelines shift outward: NEXI‑001 enrollment paused (data from enrolled patients expected Q1’23); NEXI‑003 initiation deferred—external partners may be key to progress on AIM ACT .
Cash declines remained orderly ($65.0M → $53.1M → $45.9M over Q1→Q2→Q3), consistent with OpEx trajectory and interest income tailwind, but continued execution on cost realignment is critical .
Near‑term catalyst: NEXI‑001 data for currently enrolled patients expected in Q1 2023; additional AIM INJ preclinical updates expected as the “IND engine” advances .
With no available S&P Global consensus, investor focus should be on cash runway, burn trajectory, and demonstrable AIM INJ preclinical data to support external interest and future INDs .

Additional Primary Sources Reviewed

Q3 2022 8‑K 2.02 and Exhibit 99.1 press release with full financials and strategic update .
Q2 2022 8‑K 2.02 press release and financials, including pipeline status and cash guidance .
Q1 2022 8‑K 2.02 press release and financials, including early‑year pipeline and preclinical plans .

External coverage (press wire syndications of the same Q3’22 release): BioSpace and GlobeNewswire, consistent with 8‑K content .

NexImmune, Inc. (NEXI)·Q3 2022 Earnings Summary