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Immuneering Reports Second Quarter 2024 Financial Results and Provides Business Updates
GlobeNewswire News Room· 2024-08-06 20:05
- Enrollment progressing well across all arms in the IMM-1-104 Phase 2a Trial, with Initial Data from Multiple Arms Expected in 2H 2024 - - Granted FDA Fast Track Designation for IMM-1-104 in First-line Pancreatic Cancer - - Preclinical Data Presented at AACR Demonstrates that Combining IMM-1-104 with Chemotherapies Used in the Treatment of First-line Pancreatic Cancer Yields Deeper and More Durable Tumor Growth Inhibition Than Either Treatment Alone - - Initial PK, PD and Safety Data from Phase 1/2a Trial ...
Why is Immuneering (IMRX) Stock Up 24% Today?
Investor Place· 2024-08-01 19:36
Various names in the biotech sector are seeing big moves in today's session, as investors are clearly interested in rotation into a number of higher-growth small-cap stocks. Immuneering (NASDAQ:IMRX) is certainly one such company generating outsized interest today. At the time of this writing, IMRX stock has surged more than 24% on news that the company was granted a fast track designation for its IMM-1-104 drug by the U.S. Food and Drug Administration (FDA). This drug is aimed at patients suffering from pa ...
Immuneering to Present at the Jefferies Global Healthcare Conference
globenewswire.com· 2024-05-29 20:05
About Immuneering Corporation Immuneering is a clinical-stage oncology company seeking to develop and commercialize universal-RAS/RAF medicines for broad populations of cancer patients with an initial aim to develop a universal-RAS therapy. The Company aims to achieve universal activity through Deep Cyclic Inhibition of the MAPK pathway, impacting cancer cells while sparing healthy cells. Immuneering's lead product candidate, IMM-1-104, is an oral, once- daily Deep Cyclic Inhibitor currently in a Phase 1/2a ...
Immuneering (IMRX) - 2024 Q1 - Quarterly Report
2024-05-07 20:09
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 _________________________________________________ FORM 10-Q _________________________________________________ | | For the quarterly period ended March 31, 2024 | | --- | --- | | x | QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 or | o TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _____________ to Commissi ...
Immuneering Reports First Quarter 2024 Financial Results and Provides Business Updates
Newsfilter· 2024-05-07 20:05
- Reported Positive Topline Results from Phase 1 Portion of its Phase 1/2a Clinical Trial of IMM-1-104 in RAS-Mutant Solid Tumors - - First Patient Dosed in Phase 2a Portion of Phase 1/2a Clinical Trial of IMM-1-104; Initial Data from Multiple IMM-1-104 Phase 2a Arms Expected in 2024 - - Presented Preclinical Data at AACR Demonstrating that Combining IMM-1-104 with Chemotherapies Used in The Treatment of First-line Pancreatic Cancer Yielded Deeper and More Durable Tumor Growth Inhibition Than Either Treatm ...
Immuneering (IMRX) - 2024 Q1 - Quarterly Results
2024-05-07 20:04
Exhibit 99.1 Immuneering Reports First Quarter 2024 Financial Results and Provides Business Updates - Reported Positive Topline Results from Phase 1 Portion of its Phase 1/2a Clinical Trial of IMM-1-104 in RAS- Mutant Solid Tumors - - First Patient Dosed in Phase 2a Portion of Phase 1/2a Clinical Trial of IMM-1-104; Initial Data from Multiple IMM-1-104 Phase 2a Arms Expected in 2024 - - Presented Preclinical Data at AACR Demonstrating that Combining IMM-1-104 with Chemotherapies Used in The Treatment of Fir ...
Immuneering Recognizes Melanoma Awareness Month
Newsfilter· 2024-05-06 20:30
- Two clinical stage product candidates in development for the treatment of melanoma - - RAS mutant melanoma represents one of five arms in the company's ongoing Phase 2a clinical study of IMM-1-104 - - Melanoma also being evaluated in ongoing Phase 1/2a clinical study of IMM-6-415 in patients with advanced solid tumors harboring RAF or RAS mutations - - Immuneering expects initial data from multiple IMM-1-104 Phase 2a arms in 2024 - CAMBRIDGE, Mass., May 06, 2024 (GLOBE NEWSWIRE) -- Immuneering Corporation ...
IMM-1-104 is Synergistic with Chemotherapy in Pancreatic Cancer Models
Newsfilter· 2024-04-09 16:00
- Preclinical data presented at AACR demonstrate that combining IMM-1-104 with chemotherapies used in the treatment of first-line pancreatic cancer yielded deeper and more durable tumor growth inhibition than either treatment alone - - Patients are now on treatment in multiple arms of the ongoing Phase 2a trial, including multiple patients with pancreatic cancer who are being treated with IMM-1-104 in combination with chemotherapy in the first-line setting - - Immuneering expects initial data from multiple ...
Immuneering (IMRX) - 2023 Q4 - Annual Report
2024-03-01 13:05
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 _________________________________________________________________ FORM 10-K _________________________________________________________________ (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2023 or TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission F ...
Immuneering (IMRX) - 2023 Q4 - Annual Results
2024-03-01 12:58
Immuneering Fourth Quarter and Full Year 2023 Financial Results and Business Updates [Corporate Highlights and Business Updates](index=1&type=section&id=Corporate%20Highlights%20and%20Business%20Updates) Immuneering reported significant progress in its clinical programs during 2023 and early 2024, including upcoming topline data for IMM-1-104 and initiation of IMM-6-415 dosing [IMM-1-104 Program Updates](index=1&type=section&id=IMM-1-104%20Program%20Updates) The IMM-1-104 program is rapidly advancing with expected Phase 1 topline data, expanded Phase 2a trials, and FDA Fast Track designation - Topline data from the Phase 1 portion of the Phase 1/2a trial is anticipated in **March 2024**, which will include data on tolerability, recommended Phase 2 dose (RP2D), pharmacokinetics (PK), pharmacodynamics (PD), and initial clinical activity[1](index=1&type=chunk)[4](index=4&type=chunk) - The Phase 2a portion of the trial was expanded to include **5 arms**, evaluating IMM-1-104 as a monotherapy in approximately **90 patients** across pancreatic cancer (PDAC), melanoma, and non-small cell lung cancer (NSCLC), and in combination therapy for approximately **60 PDAC patients**[4](index=4&type=chunk)[5](index=5&type=chunk) - In **February 2024**, the U.S. FDA granted Fast Track Designation for IMM-1-104 for the treatment of patients with pancreatic ductal adenocarcinoma (PDAC) who have failed one line of treatment[1](index=1&type=chunk)[5](index=5&type=chunk) - In **June 2023**, the company completed dose escalation for the Phase 1 portion, observing that doses up to **320 mg** once daily were tolerated with no dose-limiting toxicities[5](index=5&type=chunk) [IMM-6-415 Program Updates](index=2&type=section&id=IMM-6-415%20Program%20Updates) Immuneering is initiating the IMM-6-415 Phase 1/2a trial in March 2024, supported by promising preclinical data in MAPK-driven tumors - The first patient in the Phase 1/2a clinical trial of IMM-6-415 is expected to be dosed in **March 2024**[1](index=1&type=chunk)[5](index=5&type=chunk) - The Phase 1 portion will evaluate safety, tolerability, PK, and PD to identify a candidate for the recommended Phase 2 dose (RP2D), potentially enrolling up to **60 patients**. The Phase 2a dose expansion is planned for approximately **180 patients**[5](index=5&type=chunk) - Preclinical data presented in **October 2023** demonstrated high sensitivity in various MAPK-driven tumors and showed that IMM-6-415 in combination with encorafenib drove deeper regressions than the combination of binimetinib plus encorafenib in animal models[5](index=5&type=chunk) [Near-Term Milestone Expectations](index=3&type=section&id=Near-Term%20Milestone%20Expectations) The company anticipates key milestones in 2024, including topline data for IMM-1-104 and first patient dosing for IMM-6-415 - **IMM-1-104:** - Topline data from Phase 1 portion expected in March 2024 - First patient in Phase 2a portion expected to be dosed in March 2024 - Initial data from multiple Phase 2a arms expected in 2024[7](index=7&type=chunk) - **IMM-6-415:** - First patient in the Phase 1 portion of the Phase 1/2a trial expected to be dosed in March 2024[7](index=7&type=chunk) [Fourth Quarter and Full Year 2023 Financial Highlights](index=3&type=section&id=Fourth%20Quarter%20and%20Full%20Year%202023%20Financial%20Highlights) Immuneering's 2023 financial results show decreased cash, increased expenses, and a higher net loss, despite a $30 million offering - In **April 2023**, the company raised **$30 million** (**$28.2 million** net proceeds) through an underwritten offering of its Class A common stock[9](index=9&type=chunk) Cash, Cash Equivalents, and Marketable Securities | Metric | Dec 31, 2023 (in millions) | Dec 31, 2022 (in millions) | | :--- | :--- | :--- | | Cash, cash equivalents and marketable securities | $85.7 | $105.5 | Operating Expenses | Expense Category | Q4 2023 (in millions) | Q4 2022 (in millions) | Full Year 2023 (in millions) | Full Year 2022 (in millions) | | :--- | :--- | :--- | :--- | :--- | | R&D Expenses | $11.9 | $9.9 | $41.6 | $36.3 | | G&A Expenses | $4.4 | $4.1 | $16.8 | $15.6 | Net Loss and Per Share Data | Metric | Q4 2023 (in millions) | Q4 2022 (in millions) | Full Year 2023 (in millions) | Full Year 2022 (in millions) | | :--- | :--- | :--- | :--- | :--- | | Net Loss | $15.1 | $13.2 | $53.5 | $50.5 | | Net Loss Per Share ($) | $0.52 | $0.50 | $1.88 | $1.91 | [2024 Financial Guidance](index=4&type=section&id=2024%20Financial%20Guidance) Immuneering projects its current financial resources will fund operations into the second half of 2025 - The company expects its cash runway to be sufficient to fund operations into the second half of **2025**[11](index=11&type=chunk) [Financial Statements](index=6&type=section&id=Financial%20Statements) The consolidated financial statements detail Immuneering's financial position, showing a net loss and changes in assets and equity [Consolidated Statements of Operations and Comprehensive Loss](index=6&type=section&id=Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) Immuneering's 2023 operations show no revenue, increased expenses, and a net loss of $53.5 million, or $1.88 per share Consolidated Statements of Operations and Comprehensive Loss | (in thousands, except per share data) | Twelve Months Ended Dec 31, 2023 | Twelve Months Ended Dec 31, 2022 | | :--- | :--- | :--- | | Revenue | $0 | $317 | | Total operating expenses | $58,413 | $51,904 | | Loss from operations | ($58,413) | ($51,745) | | Net loss | ($53,472) | ($50,514) | | Net loss per share | ($1.88) | ($1.91) | [Consolidated Balance Sheets](index=7&type=section&id=Consolidated%20Balance%20Sheets) Immuneering's balance sheet as of December 31, 2023, shows decreased total assets and stockholders' equity, primarily due to reduced cash Consolidated Balance Sheets | (in thousands) | December 31, 2023 | December 31, 2022 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $59,406 | $72,637 | | Marketable securities, current | $26,260 | $32,888 | | Total current assets | $89,084 | $108,747 | | **Total assets** | **$102,585** | **$122,367** | | **Liabilities & Equity** | | | | Total current liabilities | $7,846 | $8,054 | | **Total liabilities** | **$12,008** | **$12,517** | | **Total stockholders' equity** | **$90,576** | **$109,850** |