Executive Summary

Q2 2020 narrowed loss materially as operating expenses declined 58% YoY (R&D -42%, G&A -26%) following the wrap-up of AVAIL enrollment and reduced Molgradex activities; net loss was $9.4M or $(0.16) vs $(21.9)M or $(0.57) in Q2 2019 .
IMPALA 2 (confirmatory P3 in aPAP) finalized: 160 patients, double‑blind, 48‑week placebo‑controlled with DLCO primary at week 24; start targeted for Q1 2021—management expressed high confidence given FDA/EMA input and improved standardization .
Cash, cash equivalents and short‑term investments were ~$99.6M at 6/30 with ~$24.9M debt; company anticipates an additional ~$46M gross proceeds from the second tranche of the Dec‑2019 financing, supporting operations and study initiations .
Near‑term stock catalysts: IMPALA 2 site activations/first‑patient‑in, AVAIL topline (CF MRSA) expected early 2021, and clarity on Apulmiq program planning with FDA; note potential headwinds from Trikafta’s impact on CF treatment landscape .

What Went Well and What Went Wrong

What Went Well
- IMPALA 2 protocol locked with global footprint (~50 sites across ~15 countries) and enhanced rigor (standardized DLCO equipment/procedures), with 90% power to detect a 5.7% improvement in DLCO; management “confident in the study design” .
  - Quote (CEO): “We are confident in the study design and believe IMPALA 2 will effectively measure the potential efficacy and safety of Molgradex to treat aPAP.”
- Expense discipline lowered quarterly burn: R&D down ~$4.4M YoY (AVAIL wind‑down, lower CMC/ops) and Molgradex program costs down ~$1.6M; G&A down ~$1.1M YoY .
- Adequate liquidity and expected financing tranche provide runway to execute on AVAIL readout and IMPALA 2 initiation; CFO reiterated capital sufficiency under current plan .
What Went Wrong
- COVID‑19 disrupted enrollment: AVAIL and ENCORE stopped enrolling in March; AVAIL primary population under‑enrolled (133/150), lowering statistical power .
- CF landscape shift: Management flagged Trikafta’s transformative effect potentially affecting AeroVanc’s addressable market; AVAIL does not assess combination with Trikafta .
- Other income swung negative vs prior year and modestly added to loss this quarter (other income (expense) net $(0.125)M in Q2 2020 vs $0.215M in Q2 2019) .

Financial Results

Metric	Q4 2019	Q1 2020	Q2 2020
Net Loss ($M)	$(31.72)	$(15.42)	$(9.39)
Diluted EPS ($)	$(0.72)	$(0.27)	$(0.16)
R&D Expense ($M)	$8.72	$13.20	$6.08
G&A Expense ($M)	$3.30	$2.98	$3.12
Total Operating Expenses ($M)	$31.51	$16.24	$9.26
Cash, Cash Equivalents & ST Investments ($M)	$121.76 (12/31/19)	$104.99 (3/31/20)	$99.61 (6/30/20)
Debt ($M)	~$25.1 (12/31/19)	~$25.0 (3/31/20)	~$24.9 (6/30/20)
Weighted Avg Shares (M)	43.82	57.36	58.86

Notes:

Revenue and gross/EBIT margins not applicable (no product revenue reported; loss from operations equals total operating expenses) .

KPIs and Program Metrics

KPI	Q4 2019	Q1 2020	Q2 2020
IMPALA 2 design status	Planning additional P3; BTD granted for Molgradex in aPAP	Expected design outlined (DLCO primary; treadmill, SGRQ secondary)	Final design announced; 160 pts; start Q1’21; 48w DB, DLCO primary
Sites / Geographies	—	—	~50 sites across ~15 countries; ~20 in US/Canada
AVAIL (AeroVanc) enrollment status	Adult fully enrolled; primary pop progressing	Enrollment closed due to COVID; 133 primary, 55 adults; topline early 2021	Same; reiterated topline early 2021
ENCORE (NTM, CF)	Ongoing	Enrollment closed; 14/∼30	Same; ~50% enrolled when halted
Liquidity runway	Cash/ST inv $121.8M	Cash/ST inv ~$105M; debt ~$25M; runway into 2022 under plan	Cash/ST inv ~$99.6M; debt ~$24.9M; anticipate ~$46M second tranche

Estimate Comparison (Wall Street Consensus)

S&P Global consensus EPS and revenue for Q2 2020 were unavailable via our data connection at this time; consequently, we cannot assess beats/misses vs consensus for this quarter. Please note to refresh later when access resumes (S&P Global consensus unavailable).

Guidance Changes

Metric	Period	Previous Guidance	Current Guidance	Change
IMPALA 2 start	Study initiation	“Initiation as soon as possible” (design expected)	Start in Q1 2021	Clarified timing
IMPALA 2 design	Study design	DLCO primary; treadmill/SGRQ secondary (expected)	Finalized: 160 pts; 48w placebo‑controlled; DLCO primary; 90% power	Finalized details
AVAIL topline	Data timing	Early 2021	Early 2021 (unchanged)	Maintained
ENCORE next steps	Program	Assess data when available	Enrollment halted (14/∼30); assess upon completion	Maintained/updated status
Cash runway / financing	Liquidity	Sufficient capital into 2022 under plan	~$99.6M cash at 6/30; expect ~$46M second tranche; sufficient to fund plan	Reiterated with tranche detail

No revenue/margin/OpEx formal financial guidance ranges were provided; updates focused on operational milestones and liquidity .

Earnings Call Themes & Trends

Topic	Previous Mentions (Q4’19 and Q1’20)	Current Period (Q2’20)	Trend
Regulatory/BTD and pivotal strategy (aPAP)	BTD for Molgradex; planning confirmatory P3; IMPALA open‑label supportive data	Final IMPALA 2 protocol set with FDA/EMA input; DLCO as primary, standardized testing	Positive momentum; higher confidence
R&D execution and COVID impacts	AVAIL enrollment continuing into Q2’20; later enrollment halt disclosed in Q1’20	AVAIL and ENCORE enrollment halted in March due to COVID; AVAIL under‑enrolled primary pop (133/150)	COVID headwind; managed continuation of enrolled pts
CF landscape/Trikafta	—	—	Management highlights Trikafta’s potential to narrow AeroVanc addressable market; AVAIL doesn’t assess combo
Apulmiq (NCFB)	Rights obtained; planning confirmatory P3 with FDA	Further analysis ongoing; planning FDA discussions potentially this year/early next; may run in parallel with IMPALA 2	Planning progressing
Financing/liquidity	Cash $121.8M YE19; debt ~$25.1M	Cash ~$99.6M; debt ~$24.9M; expect ~$46M tranche; capital sufficiency reiterated	Stable runway

Management Commentary

Strategic posture: “With a final design for IMPALA 2... we are confident in the study design and believe IMPALA 2 will effectively measure the potential efficacy and safety of Molgradex to treat aPAP.” — Rob Neville, CEO .
Confidence and rationale: “With the ability to apply key learnings from the IMPALA 2 protocol... we believe IMPALA 2 has a high likelihood of success.” — CEO .
Study design specifics: “IMPALA 2 sample size will be 160 patients… double‑blind, placebo‑controlled… efficacy assessed at week 24; 48‑week placebo‑controlled period… DLCO primary… standardized equipment… 90% powered to show 5.7% improvement.” — Badrul Chowdhury, CMO .
Liquidity: “As of June 30, 2020, we had… approximately 100 million [cash/CE/STI] with 25 million of debt… including the anticipated second tranche of approximately 46 million… sufficient capital to fund our planned operations.” — David Lowrance, CFO (see also press release figures ).

Q&A Highlights

IMPALA 2 footprint and submission timing: ~20 sites in US/Canada; ~15 total countries with EU, Japan, Korea participation; submission tied to 48‑week placebo‑controlled readout rather than 24‑week primary analysis .
Apulmiq FDA discussions and overlap: Goal to meet FDA “as soon as feasible… hopefully this year, if not early next year”; likely run Apulmiq study planning/operations in parallel with IMPALA 2 once design is set .
Whole lung lavage effect on endpoints: Management noted WLL did not show improvement in gas transfer in IMPALA as generally believed; any improvements were limited in duration, informing IMPALA 2 endpoint strategy .

Estimates Context

S&P Global consensus for Q2 2020 EPS and revenue was not retrievable at this time; as a result, we cannot quantify beats/misses versus consensus for this quarter (S&P Global consensus unavailable).
Given SVRA’s development‑stage status and no reported product revenue, investor focus should remain on opex burn vs plan and milestone timing (IMPALA 2 start, AVAIL topline) rather than near‑term P&L beats .

Key Takeaways for Investors

IMPALA 2 design lock and standardized DLCO testing reduce execution risk; start targeted Q1’21 is a clear near‑term catalyst .
Expense discipline materially narrowed the quarterly loss; watch that spend ramps back up as IMPALA 2 initiates .
Liquidity appears sufficient with ~$99.6M cash at 6/30 and an anticipated ~$46M tranche; funding overhang mitigated in the near term .
AVAIL readout in early 2021 remains a binary catalyst, but under‑enrollment in the primary population and Trikafta’s market impact temper expectations for AeroVanc .
The narrative is shifting from “design uncertainty” to “execution and enrollment” for IMPALA 2; monitor site activations and any COVID‑related disruptions .
Communication cadence change (away from quarterly calls toward event‑driven webcasts) increases the importance of tracking 8‑Ks and event updates for timely signals .

Supporting Citations: Q2 2020 8‑K and Exhibit 99.1 ; Q2 2020 earnings call transcript ; Q1 2020 8‑K/press release ; Q4 2019 8‑K/press release .

Savara Inc (SVRA)·Q2 2020 Earnings Summary