Immuneering Corp (IMRX)·Q3 2025 Earnings Summary

Executive Summary

• Q3 2025 was transformational: Immuneering reported extraordinary clinical durability (86% 9‑month OS in first‑line PDAC on atebimetinib + mGnP), secured $225M in equity financing (including a $25M Sanofi private placement), obtained a composition-of-matter patent for atebimetinib, and extended cash runway into 2029 .
• EPS beat by a penny: Q3 EPS of $0.38 loss vs S&P Global consensus of $0.388 loss; operating trends were stable with R&D $10.9M and G&A $4.5M . EPS consensus from S&P Global data.*
• Multiple near-term catalysts: regulatory feedback on the pivotal PDAC trial plan in Q4 2025; updated survival data in 1H 2026; first patient dosing in the pivotal Phase 3 mid‑2026; first patient dosing in Libtayo combo NSCLC in 2H 2026 .
• Investigators highlighted exceptional case outcomes with atebimetinib + FOLFIRINOX (one complete response; another converted to surgery with curative intent), reinforcing the tolerability/quality-of-life narrative and broad combinability potential .

What Went Well and What Went Wrong

What Went Well

• Strong survival durability in first‑line PDAC: 86% OS at 9 months (atebimetinib + mGnP, n=34, median follow‑up 9 months); CEO emphasized “I have never been more excited about our company's future” .
• Capital and runway: Closed $175M offering, $25M private placement to Sanofi, plus earlier $25M private placement; cash rose to $227.6M and runway extended into 2029 .
• Clinical anecdotes reinforce differentiation: Unconfirmed complete response and a metastatic patient converted to surgery with curative intent on atebimetinib + FOLFIRINOX; investigators cited “unexpectedly good” tolerability and “never felt better” patient experience .

What Went Wrong

• No revenue; continued operating losses: Net loss was $15.0M in Q3 (similar to prior quarters), reflecting development-stage profile with ongoing OpEx .
• Limited near‑term disclosure for FOLFIRINOX arm: Management did not guide timing to share full cohort data; priority remains mGnP combo pivotal program .
• Dilution risk highlighted: Shares outstanding rose materially with financings (63.48M issued/outstanding at 9/30/25 vs 31.05M at 12/31/24) to fund the platform and Phase 3 .

Financial Results

Notes: Company reports no revenue; income statements present operating expenses and losses without revenue lines .

KPIs (Clinical/Corporate)

• First‑line PDAC OS (atebimetinib + mGnP): 94% at 6 months (data cutoff May 26, 2025) ; 86% at 9 months with 9‑month median follow‑up .
• Standard of care (GnP) 9‑month OS context ~47% (pivotal study); management emphasized magnitude of separation .

Guidance Changes

Earnings Call Themes & Trends

Management Commentary

• “The third quarter was truly transformational… funded into 2029 and… through the topline readout of our planned pivotal Phase 3 program in pancreatic cancer.” – Ben Zeskind, CEO .
• “It is very unusual to see a complete response with chemotherapy alone in a non‑BRCA‑mutated adenocarcinoma patient like this one. I believe atebimetinib has made a real difference here.” – Dr. Allyson Ocean, Weill Cornell .
• “I believe atebimetinib helped us convert this patient to a surgical candidate with curative intent… an outcome that I have rarely seen with chemotherapy alone.” – Dr. Gregory Botta, UCSD .
• “Cash and cash equivalents… were $227.6 million… company now expects its cash runway to be sufficient to fund operations into 2029.” – Mallory Morales, CAO .
• “We’re the only company in this pathway… that’s shared overall survival data in the first‑line setting… 86% OS at 9 months… hard to beat… we’d win on tolerability.” – Ben Zeskind .

Q&A Highlights

• Priorities and settings: Company prioritizes first‑line PDAC with mGnP; adjuvant setting and 5‑FU‑based combinations are considered longer‑term options given clean safety but not near‑term priorities .
• FOLFIRINOX arm disclosure: No timing guided to disclose full cohort; case studies reinforce optionality and tolerability .
• NSCLC combos timing: Libtayo combo first patient dosing targeted for 2H 2026; Lilly olomorasib timing not yet guided; different populations (KRAS G12C vs broader IO) .
• Funding scope: Cash runway to 2029 covers Phase 3 PDAC, NSCLC combination studies, and preclinical deep cyclic inhibitor pipeline expansion .

Estimates Context

• Q3 2025 EPS: Actual $(0.38) vs consensus $(0.388)* – modest beat. Q2 2025 EPS: Actual $(0.40) vs consensus $(0.40)* – in line. Q1 2025 EPS: Actual $(0.42) vs consensus $(0.527)* – notable beat [GetEstimates].
• Revenue consensus: $0.0* for Q1–Q3, consistent with no reported revenue ].
• Target price consensus mean: $16.67* [GetEstimates].

Values marked with * retrieved from S&P Global.

Implications: Q3 and Q1 EPS outperformed modestly; sustained OpEx levels suggest estimate revisions may focus more on cash runway, study timelines, and de‑risking rather than near‑term P&L.

Key Takeaways for Investors

• The survival durability signal in first‑line PDAC (86% 9‑mo OS) and real‑world‑like case studies (CR; conversion to surgery) support a differentiated efficacy/tolerability profile, a core equity story driver into the pivotal program .
• Balance sheet strength (runway into 2029) materially de‑risks financing overhang through topline Phase 3, enabling multi‑asset execution (PDAC pivotal + NSCLC combos) .
• Regulatory and clinical catalysts (Q4’25 feedback; 1H’26 OS update; mid‑’26 Phase 3 first patient; 2H’26 Libtayo NSCLC first patient) create a steady flow of potential stock catalysts over the next 12–18 months .
• Competitive positioning narrative sharpened: management believes “first‑line is the prize” and claims advantage on both survival and tolerability; monitoring competitors’ first‑line survival disclosures is key .
• Near‑term trading setups likely hinge on regulatory feedback tone and any incremental survival/tolerability disclosures; dilution risk is largely in the rear‑view after Q3 capital raises, but share count remains elevated .
• Watch for expansion paths: adjuvant PDAC, additional chemo backbones, and vertical blockade with KRAS G12C inhibitor (Lilly) could broaden TAM if validated .
• Execution risk persists (pivotal design/regulatory alignment, recruitment, and confirmatory survival), but patent runway (to 2042, with PTE potential) supports long‑term optionality if pivotal succeeds .

Other Q3 2025 Press Releases and Prior Quarters (for trend analysis)

• Aug 25, 2025: Clinical supply agreement with Lilly for olomorasib to evaluate vertical MAPK blockade in NSCLC .
• Aug 26, 2025: Closed $25M private placement (pre‑September financings) .
• Sept 10, 2025: Announced plan to share updated OS data at PanCAN and investor call (context for 9‑mo update) .
• Q2 2025 8‑K (Aug 13): Reported 94% 6‑month OS (n=34) and EOP2 request filed; cash $26.4M; runway into 2026 .
• Q1 2025 8‑K (May 5): Positive PDAC responses; Libtayo supply agreement; cash $35.9M; runway into 2026 .

Footnote: All financial and clinical figures from company filings and press materials are cited. Estimates marked with * are values retrieved from S&P Global.