Executive Summary

Pieris reported FY 2022 results during its Q4 2022 earnings cycle: revenue $25.9M, net loss $(33.3)M, and $(0.45) basic/diluted EPS; year-end cash, cash equivalents and investments were $59.2M .
AstraZeneca materially increased resources and sites (>100) to complete the elarekibep (PRS‑060/AZD1402) Phase 2a asthma study; topline timing was pushed to mid‑2024 with protocol amendments aimed at accelerating enrollment, a key stock narrative driver .
Proprietary respiratory programs advanced: PRS‑220 Phase 1 dosing continued (topline H2 2023) and PRS‑400 moved toward development candidate nomination with more preclinical data in 2023 .
Cash burn was reduced meaningfully in H2 2022 (~$22M vs >$40M in H1), supporting runway “for more than the next 12 months” into the elarekibep readout .
Consensus estimates from S&P Global for Q4 2022 could not be retrieved due to data mapping constraints; comparisons to Street are unavailable (attempted but failed via S&P Global).

What Went Well and What Went Wrong

What Went Well

AstraZeneca increased operational commitment for elarekibep, adding countries and bringing sites to “more than 100,” and secured protocol amendments to broaden eligibility and reduce site/patient burden, improving screening dynamics .
Year-end liquidity remained solid: cash, cash equivalents and investments totaled $59.2M; management emphasized cost discipline and confidence in runway beyond 12 months .
Pipeline progress across partnerships: Seagen initiated Phase 1 for SGN‑BB228 (PRS‑346), triggering a $5M milestone; PRS‑344 dose escalation progressed with Servier; Boston Pharmaceuticals prepared PRS‑342 for Phase 1 .

Management quote: “AZ has communicated to us that Elarekibep is a high priority… increasing operational resources… adding several new countries and… more than 100 sites” .
Management quote: “Cash and cash equivalents and investments totaled $59.2 million… The company believes operations are sufficiently funded for more than the next 12 months” .

What Went Wrong

Elarekibep Phase 2a topline was delayed to mid‑2024 due to enrollment challenges and the “new normal” in respiratory trials post‑COVID, extending the catalyst timeline .
FY revenues declined to $25.9M (from $31.4M in FY 2021) and operating loss widened on lower collaboration revenues despite lower R&D and G&A; net loss was $(33.3)M .
Company must gate spend on PRS‑220 and PRS‑400 later in 2023 to prioritize cash reach to elarekibep data; 25% co‑development opt‑in may require external financing at readout .

Financial Results

Full-year comparison (context to Q4 reporting period)

Metric	FY 2021	FY 2022
Revenues ($USD Millions)	$31.418	$25.902
Total Operating Expenses ($USD Millions)	$83.249	$69.376
Loss from Operations ($USD Millions)	$(51.831)	$(43.474)
Net Loss ($USD Millions)	$(45.738)	$(33.277)
Basic/Diluted EPS ($USD)	$(0.71)	$(0.45)
Cash & Cash Equivalents ($USD Millions, year-end)	$117.764	$38.635
Short-term Investments ($USD Millions, year-end)	—	$20.534
Cash, Cash Equivalents & Investments ($USD Millions, year-end)	$117.8	$59.2

Quarterly operational metrics (prior two quarters + Q4 cash anchor)

Metric	Q2 2022	Q3 2022	Q4 2022 (context)
Net Loss ($USD Millions)	$(10.3)	$(9.7)	Not disclosed in quarterly detail; FY net loss $(33.3)
Basic/Diluted EPS ($USD)	$(0.14)	$(0.13)	Not disclosed in quarterly detail; FY $(0.45)
R&D Expense ($USD Millions)	$11.9	$13.6	FY R&D $53.0
G&A Expense ($USD Millions)	$4.1	$3.9	FY G&A $16.4
Grant Income ($USD Millions)	$1.2	$1.5	FY Grant $8.2
Cash & Equivalents + Investments ($USD Millions)	$80.9 cash	$69.8 cash+investments	$59.2 at year-end

Balance Sheet (year-end, reported with Q4 2022 cycle)

Metric	Dec 31, 2021	Dec 31, 2022
Total Current Assets ($USD Thousands)	$127,625	$73,424
Total Assets ($USD Thousands)	$153,560	$95,490
Total Current Liabilities ($USD Thousands)	$50,561	$36,583
Total Liabilities ($USD Thousands)	$102,805	$67,561
Stockholders’ Equity ($USD Thousands)	$50,755	$27,929

Notes:

Pieris did not disclose standalone Q4 revenue/EPS; management furnished FY 2022 financials and the year-end balance sheet with the Q4 2022 8‑K 2.02 and press release .

KPIs and Cash Burn

KPI	H1 2022	H2 2022
Approximate Cash Burn ($USD Millions)	>$40	~$22

No segment revenue breakdown was disclosed; revenues primarily reflect collaboration and grant income .

Guidance Changes

Metric	Period	Previous Guidance	Current Guidance	Change
Elarekibep (PRS‑060/AZD1402) Phase 2a topline timing	Asthma study	Q3 2023 (prior commentary)	Mid‑2024	Lowered (timeline pushed)
Elarekibep trial operations	Ongoing	Fewer sites; standard protocol	>100 sites; protocol broadened (FEV1 50–85%, allow high-dose ICS/LABA, simpler assessments)	Raised operational intensity
PRS‑220 Phase 1 topline	Healthy volunteers	Next year (2023)	Second half of 2023	Maintained/narrowed timing
PRS‑400 development candidate	Preclinical	Program unveiled; ongoing preclinical	Development candidate nomination later 2023; more data in 2023	Maintained with clearer milestones
Cash runway	Operating horizon	Into Q2 2024 (earlier)	“More than the next 12 months” from year-end; gating PRS‑220/PRS‑400 spend	Maintained with cost gating

Earnings Call Themes & Trends

Topic	Q2 2022 (Aug 4)	Q3 2022 (Nov 2)	Q4 2022 (Mar 29)	Trend
Elarekibep enrollment & timeline	Delay to Q3 2023; protocol simplification; focus on 3 mg efficacy	Part 1b 10 mg safety enrolled; protocol amendments submitted; topline guided to Q3 2023	Topline shifted to mid‑2024; AZ added countries/sites (>100); protocols broadened; screening improving	Increasing operational intensity; timeline extended
Post‑COVID operational headwinds	New normal for respiratory trials; masking impacts enrollment	Continued enrollment challenges, mitigation underway	Management reiterates “new normal”; screening-to-randomization lag elaborated	Persistent headwinds; mitigations progressing
Cash discipline & runway	Funded into Q2 2024; wind‑down of CINRA	Cash $69.8M; funded into Q2 2024	Cash/investments $59.2M; burn cut; runway >12 months; gating spend	Tighter spend; targeted gating
PRS‑220 development	CTN filed; Phase 1 planned in Australia	Dosing initiated; topline next year	Ongoing Phase 1; topline H2 2023	On track
PRS‑400 program	Program unveiled (ERS); preclinical PoC	Continued preclinical work	Advancing to dev candidate nomination; more preclinical data coming	Advancing
IO collaborations (Servier/Seagen/Boston)	PRS‑344 escalation; PRS‑342 and Seagen program toward clinic	Seagen IND accepted; milestone at first dosing; PRS‑342 Phase 1 expected	Seagen Phase 1 initiated ($5M milestone); PRS‑344 escalation ongoing; PRS‑342 near clinic	Multiple external catalysts

Management Commentary

Strategic priority: “Our top priority is to obtain data from the elarekibep Phase 2a study in asthma… AZ is significantly increasing operational resources to complete the trial” .
Respiratory thesis: “We believe Pieris is well positioned to develop differentiated inhaled biologics… that could fundamentally alter how respiratory diseases are managed” .
Cash discipline: “We continue to reduce our cost profile… significantly reduced cash burn of approximately $22M in H2 2022 vs more than $40M in H1… prepared to gate future investments on PRS‑220 and PRS‑400” .
Co‑development economics: “Opt‑in at 25%… cost share with cap; 50% without cap… increased share of economics for the lifetime of the program” .

Q&A Highlights

Enrollment and protocol amendments: Management detailed FEV1 inclusion broadening (50–85%), allowing high‑dose ICS/LABA, simplifying assessments; highlighted lag between screening and randomization (six weeks) .
Cash runway and opt‑in: Pieris expects to finance any 25% opt‑in at elarekibep readout externally; development plan and budget from AZ will accompany topline to inform decision .
Indication expansion economics: If Pieris opts in, economics apply to all future indications (e.g., COPD), even though the opt‑in decision is anchored to asthma .
IO spend and milestones: IO is largely off balance sheet; modest milestones expected; ~10% cash allocation to IO going forward .

Estimates Context

S&P Global consensus estimates for Q4 2022 were attempted but could not be retrieved due to missing CIQ mapping for PIRS; therefore, comparisons to Wall Street consensus for revenue and EPS are unavailable at this time (attempt via S&P Global failed).
Investors should focus on operational milestones (AZ resource ramp, protocol broadening, >100 sites, timing shift to mid‑2024) as the primary stock driver until clinical data arrive .

Key Takeaways for Investors

Elarekibep remains the core value driver; the timeline shift to mid‑2024 is offset by AZ’s increased commitment and protocol amendments aimed at enrollment acceleration—monitor site activations and screening trends in 2023–2024 .
Liquidity is sufficient to reach elarekibep topline; management is gating PRS‑220/PRS‑400 spend and cut cash burn meaningfully—reduced financing risk pre‑readout .
Proprietary respiratory assets offer optionality: PRS‑220 Phase 1 topline H2 2023 and PRS‑400 dev‑candidate nomination in 2023 can provide incremental validation of inhaled biologics strategy .
Partnership catalysts continue: Seagen’s Phase 1 start delivered $5M; PRS‑344 escalation ongoing with Servier; Boston’s PRS‑342 near the clinic—non‑dilutive progress supports runway and sentiment .
Co‑development opt‑in mechanics are attractive: 25% level with cost cap and enhanced lifetime economics; 50% increases upside—final decision will hinge on the quality of topline and AZ’s development plan .
Near-term trading: Stock likely to trade on execution signals (site additions, screening/randomization updates) and cash discipline rather than quarterly P&L; mid‑2024 remains the key binary .
Medium-term thesis: If elarekibep validates inhaled IL‑4Rα in asthma, COPD expansion could materially increase TAM with favorable co‑development economics if opt‑in is exercised .

Sources: 8‑K 2.02 and press release (Mar 29, 2023) ; Q4 2022 earnings call transcript (Mar 29, 2023) ; Q3 2022 earnings call transcript (Nov 2, 2022) ; Q2 2022 earnings call transcript (Aug 4, 2022) .

PIERIS PHARMACEUTICALS, INC. (PIRS)·Q4 2022 Earnings Summary