- Establishment reflects the clinical progress of IMM-1-104 and its promise in pancreatic cancer - - Follows recent Orphan Drug designation in pancreatic cancer and Fast Track designations in first- and second-line pancreatic cancer for IMM-1-104 - CAMBRIDGE, Mass., Dec. 19, 2024 (GLOBE NEWSWIRE) -- Immuneering Corporation (Nasdaq: IMRX), a clinical-stage oncology company seeking to develop and commercialize universal-RAS/RAF medicines for broad populations of cancer patients, today announced the formation ...

- The company will provide additional data from IMM-1-104 in combination with modified gemcitabine/nab-paclitaxel (mGnP) in first-line pancreatic cancer - - The company will also provide initial data from IMM-1-104 in combination with modified FOLFIRINOX (mFFX) in first-line pancreatic cancer, as well as IMM-1-104 monotherapy in second-line pancreatic cancer - CAMBRIDGE, Mass., Dec. 17, 2024 (GLOBE NEWSWIRE) -- Immuneering Corporation (Nasdaq: IMRX), a clinical-stage oncology company seeking to develop and ...

- IMM-1-104 has the potential to benefit melanoma patients who have progressed on or are intolerant to immune checkpoint inhibitors - - IMM-1-104 was observed to be uniquely well tolerated in Phase 1 data shared at ESMO 2024, relative to MEK inhibitors currently used to treat melanoma - - Melanoma patients actively enrolling in one of five arms in the company’s ongoing Phase 2a clinical study of IMM-1-104 - CAMBRIDGE, Mass., Dec. 12, 2024 (GLOBE NEWSWIRE) -- Immuneering Corporation (Nasdaq: IMRX), a clinica ...

CAMBRIDGE, Mass., Nov. 27, 2024 (GLOBE NEWSWIRE) -- Immuneering Corporation (Nasdaq: IMRX), a clinical-stage oncology company seeking to develop and commercialize universal-RAS/RAF medicines for broad populations of cancer patients, today announced that management will present at the Piper Sandler 36th Annual Healthcare Conference, which is taking place at the Lotte New York Palace in New York City from December 3-5, 2024, to discuss the company’s pipeline, platform, and business strategy. Participating wil ...

- Announced Positive Initial Data, Including Complete and Partial Responses, with IMM-1-104 in Combination with Chemotherapy in First-Line Pancreatic Cancer Patients - - Granted FDA Orphan Drug Designation for IMM-1-104 in the Treatment of Pancreatic Cancer and Fast Track Designation in First-line Pancreatic Cancer - - Initial Data From At Least One Additional Arm of the Phase 2a Portion of the IMM-1-104 Phase 1/2a Trial Expected by Year End - - Cash Runway into Fourth Quarter 2025 - CAMBRIDGE, Mass., Nov. ...

Financial Performance - Net loss for Q3 2024 was $14.6 million, or $0.49 per share, compared to a net loss of $12.6 million, or $0.43 per share, in Q3 2023[8]. - Total operating expenses for Q3 2024 were $15.3 million, compared to $13.9 million in Q3 2023, reflecting a year-over-year increase of 9.7%[15]. - Research and Development (R&D) expenses for Q3 2024 were $11.3 million, an increase of 11.9% from $10.1 million in Q3 2023[6]. - General and Administrative (G&A) expenses for Q3 2024 were $4.0 million, slightly up from $3.9 million in Q3 2023[7]. Cash Position - Cash position as of September 30, 2024, was $50.7 million, down from $85.7 million as of December 31, 2023[5]. - The company expects its cash runway to fund operations into the fourth quarter of 2025[9]. - Cash and cash equivalents decreased from $59,405,817 to $45,205,577, representing a decrease of about 24%[17]. - Total current assets decreased from $89,083,669 on December 31, 2023, to $55,259,501 on September 30, 2024, a decline of approximately 38%[17]. Assets and Liabilities - Total assets decreased from $102,584,538 to $68,557,104, a decline of approximately 33%[17]. - Total liabilities decreased from $12,008,355 to $10,836,290, a reduction of approximately 10%[17]. - Stockholders' equity decreased from $90,576,183 to $57,720,814, a decline of about 36%[17]. - Accumulated deficit increased from $(163,258,578) to $(206,243,700), reflecting a worsening of approximately 26%[17]. - Additional paid-in capital increased from $253,806,267 to $263,925,619, an increase of about 4%[17]. - Accounts payable decreased from $2,111,666 to $1,942,782, a reduction of about 8%[17]. - Accrued expenses decreased from $5,173,960 to $4,592,825, a decline of approximately 11%[17]. - Marketable securities decreased significantly from $26,259,868 to $5,452,155, a drop of about 79%[17]. Clinical Development - Positive initial data for IMM-1-104 in combination with chemotherapy showed complete and partial responses in first-line pancreatic cancer patients[2]. - FDA granted Orphan Drug designation for IMM-1-104 in October 2024, and Fast Track designation in July 2024 for first-line pancreatic cancer treatment[4][3]. - Initial data from at least one additional arm of the Phase 2a trial is expected by year-end 2024[4]. - The company aims to develop universal-RAS/RAF medicines targeting broad populations of cancer patients[10].

Core Insights - Immuneering Corporation's lead product candidate, IMM-1-104, has received orphan drug designation from the FDA for treating pancreatic cancer, resulting in a 15.5% increase in the company's shares on October 15 [1][3]. Company Developments - The FDA's orphan drug designation supports the development of treatments for rare disorders affecting fewer than 200,000 patients in the U.S., providing seven years of market exclusivity post-approval, tax credits for clinical studies, and exemptions from certain FDA fees [2]. - IMM-1-104 was previously granted Fast Track designation for first- and second-line pancreatic cancer treatment, but year-to-date, Immuneering's shares have decreased by 68.6%, contrasting with a 1.8% decline in the industry [3]. - The company announced positive early response data from an ongoing study of IMM-1-104 combined with chemotherapy in first-line pancreatic cancer patients [3][5]. - IMM-1-104 is being evaluated in a phase I/IIa study for advanced solid tumors with RAS mutations, with a phase IIa study assessing its use as a monotherapy and in combination with different chemotherapy regimens for pancreatic cancer [4][6]. Pipeline and Future Prospects - The combination of IMM-1-104 and modified gemcitabine/nab-paclitaxel has shown a well-tolerated safety profile in pancreatic cancer patients, with additional data expected by the end of 2024 [5]. - Immuneering is also developing another candidate, IMM-6-415, for advanced solid tumors with RAS or RAF mutations, focusing on pipeline development in the absence of an approved product [6].

Immuneering Corporation (IMRX) soared 41.3% on Friday after it reported promising early response data from the first five patients of an ongoing early to mid-stage study evaluating IMM-1-104 combined with chemotherapy (modified gemcitabine/nab-paclitaxel) for treating first-line pancreatic cancer. IMM-1-104, an investigational RAS medication, is Immuneering's lead pipeline candidate, which is being evaluated in the phase I/IIa study in patients with advanced solid tumors harboring RAS mutations. The phase I ...

- In Phase 2a arm investigating IMM-1-104 in combination with modified gemcitabine/nab-paclitaxel, complete or partial responses have been observed in the first two patients (2/5) to date, for an initial response rate of 40% and an initial disease control rate of 80%, with all five patients continuing on treatment - - Initial data are at 240 mg QD (safety lead-in dose) of IMM-1-104; additional patients have now been dosed at 320 mg QD in this arm; IMM-1-104 has been well-tolerated to date in combination wit ...

Clinical Trials and Developments - Enrollment in the IMM-1-104 Phase 2a Trial is progressing well, with initial data from multiple arms expected in the second half of 2024[1] - The FDA granted Fast Track designation for IMM-1-104 as a first-line treatment for pancreatic ductal adenocarcinoma (PDAC) in July 2024[3] - Initial pharmacokinetic (PK), pharmacodynamic (PD), and safety data from the Phase 1 portion of the IMM-6-415 trial are expected in the second half of 2024[4] - Preclinical data presented at AACR showed that combining IMM-1-104 with chemotherapy yields deeper and more durable tumor growth inhibition than either treatment alone[3] - The company is evaluating IMM-1-104 in monotherapy arms for patients with RAS mutant melanoma and lung cancer, alongside pancreatic cancer patients[2] Financial Performance - R&D expenses for Q2 2024 were $10.7 million, an increase of 12.6% from $9.5 million in Q2 2023[5] - G&A expenses for Q2 2024 were $4.3 million, up from $4.0 million in the same period of 2023[5] - The net loss attributable to common stockholders for Q2 2024 was $14.1 million, or $0.47 per share, compared to a net loss of $12.2 million, or $0.43 per share, in Q2 2023[6] Cash and Assets - Cash, cash equivalents, and marketable securities as of June 30, 2024, were $59.7 million, down from $85.7 million as of December 31, 2023[5] - The company expects its cash runway to be sufficient to fund operations into the second half of 2025[7] - Total current assets decreased from $89,083,669 on December 31, 2023, to $63,685,675 on June 30, 2024, representing a decline of approximately 28.5%[15] - Cash and cash equivalents increased slightly from $59,405,817 to $59,728,455, showing a growth of about 0.5%[15] - Total assets decreased from $102,584,538 to $77,087,275, a decline of approximately 25%[15] Liabilities and Equity - Total liabilities decreased from $12,008,355 to $10,781,640, a reduction of approximately 10.2%[15] - Accumulated deficit increased from $(163,258,578) to $(191,646,334), indicating a worsening of about 17.4%[15] - Total stockholders' equity decreased from $90,576,183 to $66,305,635, a decline of approximately 26.8%[15] - Additional paid-in capital rose from $253,806,267 to $257,922,316, reflecting an increase of about 1.7%[15] Current Liabilities and Assets - Current liabilities decreased from $7,845,503 to $6,781,086, a reduction of about 13.5%[15] - Property and equipment, net decreased from $1,400,582 to $1,290,091, a decline of approximately 7.9%[15] - Right-of-use assets, net decreased from $3,995,730 to $3,827,943, a reduction of about 4.2%[15]