axelvento
6日前
In addition to eliciting 17.3 months median overall survival vs. 8.5 months for patients given standard of care treatment in a prior study, Immuneering’s atebimetinib demonstrated a robust tolerability profile—something CEO Ben Zeskind said equates highly with survival.
Immuneering’s investigational pancreatic cancer drug gave patients in a mid-stage trial nearly nine additional months of survival—adding another potential weapon to the quickly advancing next-gen treatment arsenal for the deadly disease.
In a Phase 2a trial, the MEK-targeting deep cyclic inhibitor atebimetinib plus modified gemcitabine/nab-paclitaxel (mGnP) elicited 17.3-months median overall survival (MOS), compared with 8.5 months for patients given gemcitabine/nab-paclitaxel in the pivotal Phase 3 MPACT study. Abraxane (nab-paclitaxel) in combination with gemcitabine, a regimen known as GnP, has been the standard of care for late-stage pancreatic cancer since Abraxane’s approval in 2013.
Median progression-free survival for the atebimetinib/chemotherapy combo was 8.3 months, while the disease control rate was 82%. The confirmed overall response rate was 36%.
The data come from 55 patients with first-line metastatic pancreatic cancer given 320 mg of atebimetinib plus mGnP. Immuneering first reported the overall survival results on May 21 and elaborated on the data Monday in an oral presentation at the American Society of Clinical Oncology (ASCO) annual meeting.
These results for atebimetinib follow Revolution Medicines’ groundbreaking pancreatic cancer win, when its RAS inhibitor daraxonrasib doubled survival in the second line setting in a Phase 3 trial whose results were announced in April. In an interview with BioSpace prior to the ASCO presentation, Immuneering CEO Ben Zeskind put the company’s results into the context of the overall pancreatic cancer treatment space.
“We kind of have cancer surrounded,” he said. “Those RAS inhibitors are making a really good attack from the second line direction. We think 17.3 months is a really compelling median overall survival coming from the first-line direction.”
Zeskind also noted the consistency of atebimetinib’s results. In the original 34-patient cohort with a median follow-up of 17 months, MOS was likewise 17.3 months, according to Immuneering’s press release on Monday. “I think [it] really speaks to the robustness of the data,” he said.
Immuneering’s initial recruitment goal for the Phase 2a trial was 30 patients, but “there was just so much demand at our sites” because of what investigators were observing, and “we kind of took as many more patients as we could.”
Tolerability equals survival
Notably, the biotech observed only two categories of Grade 3 or higher treatment-related adverse events in at least 10% of participants—both of which Zeskind said were related to the chemo.
“I think the tolerability is certainly something to highlight,” Meredith Pelster, associate director of gastrointestinal cancer research at the Sarah Cannon Research Institute and an investigator on the Phase 2a trial, told BioSpace. “With the modified gemcitabine/nab-paclitaxel schedule, I’m not having to deal with the degree of cytopenias I typically would, and then the addition of atebimetinib, really we’re not seeing high-grade toxicity at all . . . . Keeping these patients on treatment is not challenging.”
While daraxonrasib appears to be extremely efficacious, it does come with some problematic side effects. The majority of patients on Revolution’s drug develop a rash—a side effect apparent in a recent 60 Minutes interview with former Nebraska Sen. Ben Sasse. Sasse credited daraxonrasib with decreasing his pain and reducing his tumor volume by 76%, USA Today reported, but a rash was evident on his face.
In the Phase 3 RASolute 302 trial, 43.6% of patients on daraxonrasib experienced a grade 3 or higher treatment-related adverse event (TRAE), compared to 57.5% of patients receiving chemo. However, just 1.2% of patients stopped treatment with Revolution’s drug due to these TRAEs.
Immuneering’s results “kind of redefine the tradeoffs” patients have to make, Zeskind said. “It used to be really that patients had to choose between survival and tolerability, between more time and the quality of that time, and I think the possibility that these data raise is that patients may have to make fewer trade-offs.”
Tolerability is not only important for quality of life, Zeskind added, but is also key to survival. When a patient’s status declines to a certain level on a key performance scale, he said, there is around a 48% increase in the risk of death. “Similarly, if they’re so beat up by the first-line therapy that they can’t go on to second-line therapy, in the literature, it’s about a 51% increase in the risk of death.”
In Immuneering’s trial, 84% of participants maintained or gained weight at three months—a particular challenge for patients with pancreatic cancer, according to Zeskind.
“The tolerability, the weight stability and gain, and the median overall survival—these are all, we think, important characteristics for a first-line treatment,” he said.
Notably, Immuneering’s stock began to fall following the data. The company’s shares were down nearly 24% as of 3 pm Eastern time on Monday.
Mizuho analysts, in a midday note, said, “The weakness appears way overdone.”
The firm attributed the “intra-day weakness” to a “slight diminution of the ORR to 36% (vs. 39% previously),” and the news that one patient discontinued treatment with atebimetinib. Having spoken with Immuneering’s management, however, the analysts said they did not have any concerns.
Next up, Immuneering intends to dose the first patient in the Phase 3 MAPKeeper 301 trial around the middle of this year. The biotech is planning to enroll around 510 patients in this study, Zeskind said, and expects to report topline results in mid-2028.
“We’re all very excited,” about the upcoming Phase 3 trial, said Pelster, who will also serve as an investigator on this study. “We need to prove that the combination is superior to standard of care, and when that happens, then we can really get this drug to people to make a difference.”Immuneering’s results “kind of redefine the tradeoffs” patients have to make, Zeskind said. “It used to be really that patients had to choose between survival and tolerability, between more time and the quality of that time, and I think the possibility that these data raise is that patients may have to make fewer trade-offs.”
Tolerability is not only important for quality of life, Zeskind added, but is also key to survival. When a patient’s status declines to a certain level on a key performance scale, he said, there is around a 48% increase in the risk of death. “Similarly, if they’re so beat up by the first-line therapy that they can’t go on to second-line therapy, in the literature, it’s about a 51% increase in the risk of death.”
In Immuneering’s trial, 84% of participants maintained or gained weight at three months—a particular challenge for patients with pancreatic cancer, according to Zeskind.
“The tolerability, the weight stability and gain, and the median overall survival—these are all, we think, important characteristics for a first-line treatment,” he said.
Notably, Immuneering’s stock began to fall following the data. The company’s shares were down nearly 24% as of 3 pm Eastern time on Monday.
Mizuho analysts, in a midday note, said, “The weakness appears way overdone.”
The firm attributed the “intra-day weakness” to a “slight diminution of the ORR to 36% (vs. 39% previously),” and the news that one patient discontinued treatment with atebimetinib. Having spoken with Immuneering’s management, however, the analysts said they did not have any concerns.
Next up, Immuneering intends to dose the first patient in the Phase 3 MAPKeeper 301 trial around the middle of this year. The biotech is planning to enroll around 510 patients in this study, Zeskind said, and expects to report topline results in mid-2028.
“We’re all very excited,” about the upcoming Phase 3 trial, said Pelster, who will also serve as an investigator on this study. “We need to prove that the combination is superior to standard of care, and when that happens, then we can really get this drug to people to make a difference.”
https://www.biospace.com/drug-development/asco-biopharma-has-pancreatic-cancer-surrounded-as-immuneerings-drug-adds-9-quality-months
axelvento
2週前
In a report released , Graig Suvannavejh from Mizuho Securities reiterated a Buy rating on Immuneering, with a price target of $12.00.
Mizuho added—Concurrent with its ASCO abstract released yesterday, in a surprise, IMRX separately announced first-ever median overall survival/mOS data for lead asset atebimetinib/atebi in 1L metastatic pancreatic cancer/PanCa patients.
In a significant positive, IMRX reported an astounding 17.3 months mOS for atebi — easily beating current standard of care treatments.
This data, which comes as a teaser of what will be presented at next week's ASCO meeting, comes from all 55 1L metastatic PanCa patients treated with atebi plus modified gemcitabine + nab-paclitaxel/mGnP in the company's ongoing P2a study.
Full data, including OS, PFS, response, weight stability/cachexia and safety/tolerability will be presented at an oral session at ASCO on June 1, with IMRX also hosting a conference call on the data that morning.
With the impressive results and detailed ASCO data representing a near-term stock catalyst, we reiterate our OP rating on IMRX.
The bottom line: On first blush, we come away very impressed by the new mOS data for atebi. In broader context, yes, we acknowledge the new efficacy bars that have been set by RVMD's dara in PDAC, data which come from later stage studies; that said, at this point, we favor atebi's clear edge on tolerability, and recently reported ctDNA data on acquired alterations (LINK) support atebi's resistance-sparing profile for 2L RAS inhibitor use, which help to maintain atebi's potential 1L opp'y.
With this mind, seeing a stock catalyst with new ASCO data, and favorable risk/reward, we stay OP-rated on IMRX.
georgie18
2週前
IMRX...$6.79...🥳... Think its a $20 plus ticker...
georgie18
Re: georgie18 post# 284
Thursday, April 23, 2026 12:08:26 PM
Post#
286
of 288
IMRX...$6.03...🥳...
georgie18
Re: georgie18 post# 283
Tuesday, April 14, 2026 9:39:09 AM
Post#
284
of 285
IMRX...$5.86...🥳...$4.45 Average for me...Long Hold...Think its a $20 plus ticker...
georgie18
Re: georgie18 post# 276
Wednesday, March 25, 2026 10:21:06 AM
Post#
283
of 283
IMRX...$5.45...🥳...Bullish Psar Flip...
georgie18
Member Level
Re: georgie18 post# 274
Thursday, January 22, 2026 12:41:51 PM
Post#
276
of 282
IMRX...$5.24...🥳...Beauty move off the $4 range bottom... $4.45 average for me...
georgie18
Member Level
Re: georgie18 post# 712333
Thursday, January 22, 2026 9:55:50 AM
Post#
712373
of 712451
IMRX...$5.07...🥳...Beauty move off the $4 range bottom... $4.45 average for me...
georgie18
Member Level
Re: georgie18 post# 272
Thursday, January 22, 2026 8:19:57 AM
Post#
273
of 273
IMRX...$4.89...🥳
georgie18
Member Level
Re: georgie18 post# 711681
Wednesday, January 21, 2026 8:41:43 AM
Post#
712185
of 712332
IMRX...$4.76...🥳...Reversing Nicely...off the $4.03 Bottom...
georgie18
Member Level
Re: georgie18 post# 268
Thursday, January 15, 2026 10:10:22 AM
Post#
270
of 271
IMRX...$4.66...🥳
georgie18
Member Level
Re: georgie18 post# 711552
Wednesday, January 14, 2026 2:34:45 PM
Post#
711597
of 711680
IMRX...$4.42...🥳...Reversing Nicely...off the $4.03 Bottom...
georgie18
Member Level
Re: georgie18 post# 266
Wednesday, January 14, 2026 12:03:43 PM
Post#
267
of 267
IMRX...Added $4.20s...🥳...Own from $4.20 to $5.45... This is $18 plus imo...we shall see..
georgie18
1月前
IMRX...$6.03...🥳...
georgie18
Re: georgie18 post# 283
Tuesday, April 14, 2026 9:39:09 AM
Post#
284
of 285
IMRX...$5.86...🥳...$4.45 Average for me...Long Hold...Think its a $20 plus ticker...
georgie18
Re: georgie18 post# 276
Wednesday, March 25, 2026 10:21:06 AM
Post#
283
of 283
IMRX...$5.45...🥳...Bullish Psar Flip...
georgie18
Member Level
Re: georgie18 post# 274
Thursday, January 22, 2026 12:41:51 PM
Post#
276
of 282
IMRX...$5.24...🥳...Beauty move off the $4 range bottom... $4.45 average for me...
georgie18
Member Level
Re: georgie18 post# 712333
Thursday, January 22, 2026 9:55:50 AM
Post#
712373
of 712451
IMRX...$5.07...🥳...Beauty move off the $4 range bottom... $4.45 average for me...
georgie18
Member Level
Re: georgie18 post# 272
Thursday, January 22, 2026 8:19:57 AM
Post#
273
of 273
IMRX...$4.89...🥳
georgie18
Member Level
Re: georgie18 post# 711681
Wednesday, January 21, 2026 8:41:43 AM
Post#
712185
of 712332
IMRX...$4.76...🥳...Reversing Nicely...off the $4.03 Bottom...
georgie18
Member Level
Re: georgie18 post# 268
Thursday, January 15, 2026 10:10:22 AM
Post#
270
of 271
IMRX...$4.66...🥳
georgie18
Member Level
Re: georgie18 post# 711552
Wednesday, January 14, 2026 2:34:45 PM
Post#
711597
of 711680
IMRX...$4.42...🥳...Reversing Nicely...off the $4.03 Bottom...
georgie18
Member Level
Re: georgie18 post# 266
Wednesday, January 14, 2026 12:03:43 PM
Post#
267
of 267
IMRX...Added $4.20s...🥳...Own from $4.20 to $5.45... This is $18 plus imo...we shall see..
georgie18
2月前
IMRX...$5.86...🥳...$4.45 Average for me...Long Hold...Think its a $20 plus ticker...
georgie18
Re: georgie18 post# 276
Wednesday, March 25, 2026 10:21:06 AM
Post#
283
of 283
IMRX...$5.45...🥳...Bullish Psar Flip...
georgie18
Member Level
Re: georgie18 post# 274
Thursday, January 22, 2026 12:41:51 PM
Post#
276
of 282
IMRX...$5.24...🥳...Beauty move off the $4 range bottom... $4.45 average for me...
georgie18
Member Level
Re: georgie18 post# 712333
Thursday, January 22, 2026 9:55:50 AM
Post#
712373
of 712451
IMRX...$5.07...🥳...Beauty move off the $4 range bottom... $4.45 average for me...
georgie18
Member Level
Re: georgie18 post# 272
Thursday, January 22, 2026 8:19:57 AM
Post#
273
of 273
IMRX...$4.89...🥳
georgie18
Member Level
Re: georgie18 post# 711681
Wednesday, January 21, 2026 8:41:43 AM
Post#
712185
of 712332
IMRX...$4.76...🥳...Reversing Nicely...off the $4.03 Bottom...
georgie18
Member Level
Re: georgie18 post# 268
Thursday, January 15, 2026 10:10:22 AM
Post#
270
of 271
IMRX...$4.66...🥳
georgie18
Member Level
Re: georgie18 post# 711552
Wednesday, January 14, 2026 2:34:45 PM
Post#
711597
of 711680
IMRX...$4.42...🥳...Reversing Nicely...off the $4.03 Bottom...
georgie18
Member Level
Re: georgie18 post# 266
Wednesday, January 14, 2026 12:03:43 PM
Post#
267
of 267
IMRX...Added $4.20s...🥳...Own from $4.20 to $5.45... This is $18 plus imo...we shall see..
12yearplan
5月前
Done loading, let's go lolz.. 🤑
IMRX$
Here’s a **clear, fact-based picture** of **Immuneering Corporation (NASDAQ: IMRX)** and its **cash burn / runway situation** — key to understanding whether it can make it into the new year *without another financing (i.e., dilutive raise)*.
---
## 🔎 Current Cash & Cash Burn
### **1) Historical cash burn & runway (pre-late 2025 financing)**
* In **2024**, IMRX burned about **$55 M** of cash from operations. ([SEC][1])
* Quarterly operating cash burn in early 2025 was roughly **$14–15 M per quarter** (~$56–60 M annually). ([SEC][2])
* Based on a **~$36 M cash balance as of early 2025**, that implied only **~8 months of runway** without additional financing. ([Sahm][3])
This early 2025 picture was **not enough to go into the new year without another raise** unless the company cut spending sharply or suddenly generated revenue — which it did not.
---
## 💰 **Major Equity Raises Changed the Situation**
Recent financing dramatically altered the runway calculation:
### **2) Large capital raises in mid/late 2025**
* IMRX raised significant equity capital in **August/September 2025**, including a **private placement and underwritten offerings**, with participation from strategic investors like Sanofi. ([Fintool][4])
* Multiple financial reporting tools now show **cash & equivalents around ~$227–228 M** as of late 2025. ([Accountable Finance][5])
This is a **game-changer**:
* With a historical annual cash burn near **~$50–60 M**, ~$228 M gives **roughly 4+ years of runway** if burn remains consistent. ([Accountable Finance][5])
* Third-quarter 2025 results and commentary suggest **runway into 2029** barring major changes. ([GuruFocus][6])
---
## 📊 **So, does it need a raise to make the new year?**
### **Before the 2025 raises**
* **No —** cash on hand + burn rate *would not have been sufficient* to cover the entire 2025–2026 period without another raise. ([SEC][2])
### **After the 2025 raises**
* **Yes —** the company *now* appears to have enough runway through multiple years (beyond 2026) **without immediate additional financing**, assuming it manages expenses at typical levels. ([Accountable Finance][5])
* This means **no near-term orchestrated capital raise may be needed strictly for cash purposes**, as long as the burn rate doesn’t accelerate materially.
---
## ⚠️ **Important Risks & Caveats**
* IMRX still **has no product revenue**, so it is entirely dependent on financing and partnerships. ([Nasdaq][7])
* Clinical R&D is expensive and unpredictable — if programs expand or face delays, burn could accelerate.
* Runway estimates assume relatively stable spend; **unexpected costs could shorten it**.
---
## 📌 **Bottom Line**
✅ **Before the 2025 financing**, IMRX’s burn and cash balance *would not have carried it comfortably through a full year ending in 2026 without a raise.* ([Sahm][3])
✅ **After the mid-to-late 2025 capital raises**, IMRX now appears to have a **multi-year cash runway** (into 2029) at its historical burn rate, making short-term cash raises *not immediately necessary* solely for keeping operations going. ([Accountable Finance][5])
---
If you’d like, I can walk through how to estimate runway yourself (step-by-step), or calculate a more precise forecast based on different burn scenarios.
[1]: https://www.sec.gov/Archives/edgar/data/1790340/000179034025000042/imrx-20241231.htm?utm_source=chatgpt.com "imrx-20241231"
[2]: https://www.sec.gov/Archives/edgar/data/0001790340/000179034025000061/imrx-20250331.htm?utm_source=chatgpt.com "imrx-20250331"
[3]: https://www.sahmcapital.com/news/content/heres-why-immuneering-nasdaqimrx-must-use-its-cash-wisely-2025-07-01?utm_source=chatgpt.com "Here's Why Immuneering (NASDAQ:IMRX) Must Use Its Cash Wisely"
[4]: https://fintool.com/app/research/companies/IMRX/earnings/Q2%202025?utm_source=chatgpt.com "Immuneering Corp (IMRX) Q2 2025 Earnings Summary | Fintool"
[5]: https://accountable.finance/stock/IMRX?utm_source=chatgpt.com "Immuneering Corp (IMRX) Stock: Fundamentals & Strategy Insights | Accountable Finance"
[6]: https://www.gurufocus.com/news/3204880/imrx-expects-cash-reserves-to-sustain-operations-through-2029?utm_source=chatgpt.com "IMRX Expects Cash Reserves to Sustain Operations Through 2029"
[7]: https://www.nasdaq.com/articles/immuneering-posts-narrower-loss-q2?utm_source=chatgpt.com "Immuneering Posts Narrower Loss in Q2 | Nasdaq"