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 ...

Core Insights - Immuneering Corporation announced positive initial data for IMM-1-104 in combination with chemotherapy for first-line pancreatic cancer patients, showing complete and partial responses [1][4] - The FDA granted Orphan Drug and Fast Track designations for IMM-1-104, which may expedite its development for pancreatic cancer treatment [3][5] - The company expects to release additional data from the Phase 2a trial by the end of the year and has a cash runway extending into the fourth quarter of 2025 [10][6] Clinical Development - Positive initial response data from the Phase 2a clinical trial indicated a complete response and impressive disease control among the first five patients treated with IMM-1-104 combined with modified gemcitabine/nab-paclitaxel [2][4] - The management believes that if early trends continue, there will be a clear path for further clinical development of IMM-1-104 in pancreatic cancer, which is a significantly underserved patient population [2][4] Regulatory Designations - The FDA granted Orphan Drug designation to IMM-1-104 for pancreatic cancer treatment in October 2024, which provides certain benefits to expedite development [3] - Fast Track designation was granted in July 2024 for IMM-1-104 as a first-line treatment for patients with pancreatic ductal adenocarcinoma (PDAC) [5] Financial Performance - As of September 30, 2024, the company reported cash, cash equivalents, and marketable securities totaling $50.7 million, down from $85.7 million at the end of 2023 [6] - Research and Development (R&D) expenses for Q3 2024 were $11.3 million, an increase from $10.1 million in Q3 2023, primarily due to higher clinical costs [7] - General and Administrative (G&A) expenses for Q3 2024 were $4.0 million, slightly up from $3.9 million in Q3 2023, attributed to increased stock-based compensation and employee-related costs [8] Net Loss - The net loss attributable to common stockholders 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, for the same period in 2023 [9]

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].

Core Insights - Immuneering Corporation (IMRX) experienced a significant stock increase of 41.3% following the release of promising early response data from an ongoing study of its drug IMM-1-104 combined with chemotherapy for pancreatic cancer [1][3]. Company Overview - IMM-1-104 is Immuneering's lead pipeline candidate, currently in a phase I/IIa study targeting advanced solid tumors with RAS mutations [2]. - The phase IIa study is assessing the 320mg dose of IMM-1-104 both as a monotherapy and in combination with chemotherapy regimens for pancreatic cancer, as well as for non-small cell lung cancer and melanoma [2]. Clinical Data - Initial results from the first five patients in the phase IIa study show a 40% initial response rate, with a disease control rate of 80% [3]. - The observed response rate of 40% is significantly higher than the benchmark overall response rate (ORR) of 23% for gemcitabine/nab-paclitaxel alone [4]. Safety and Tolerability - The combination therapy of IMM-1-104 and modified gemcitabine/nab-paclitaxel has been well tolerated among patients, maintaining a consistent safety profile [6]. Future Development Plans - The study's independent monitoring body has approved the enrollment of additional patients for the IMM-1-104 treatment arm, with new patients already beginning treatment [7]. - Immuneering expects to release initial efficacy data from at least one additional arm of the phase IIa study by the end of 2024 [8]. Market Performance - Year to date, shares of Immuneering have decreased by 72.5%, contrasting with a 0.5% growth in the industry [6].

Core Insights - Immuneering Corporation announced positive initial response data for IMM-1-104 in combination with modified gemcitabine/nab-paclitaxel for first-line pancreatic cancer, showing an overall response rate (ORR) of 40% and a disease control rate (DCR) of 80% from the first five patients treated [1][5][6] Clinical Trial Results - In the Phase 2a trial, two out of five patients exhibited complete or partial responses, leading to an initial ORR of 40% and a DCR of 80%, with all patients continuing treatment [1][5] - The initial data from the trial is consistent with preclinical findings that indicated IMM-1-104 combined with chemotherapy could induce deeper responses than either agent alone [1][6] - The trial has progressed to dosing additional patients at 320 mg QD, following the approval from the Data and Safety Monitoring Board (DSMB) based on the emerging safety profile [5][6] Future Development - The company expects a clear path forward for the clinical development of IMM-1-104 in combination with gemcitabine/nab-paclitaxel for pancreatic cancer, especially given the FDA's Fast Track designation for this treatment [1][5] - Further data from the ongoing Phase 2a arms is anticipated by the end of the year, with a focus on evaluating the efficacy of IMM-1-104 across various tumor types [2][8] Company Overview - Immuneering Corporation is a clinical-stage oncology company focused on developing universal-RAS/RAF medicines, with IMM-1-104 as its lead product candidate currently in a Phase 1/2a trial for advanced solid tumors harboring RAS mutations [10][11] - The company aims to achieve universal-RAS activity through Deep Cyclic Inhibition of the MAPK pathway, selectively impacting cancer cells while sparing healthy cells [10][11]

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]

Core Insights - Immuneering Corporation is progressing well in its IMM-1-104 Phase 2a trial, with initial data from multiple arms expected in the second half of 2024 [1][2] - The FDA has granted Fast Track designation for IMM-1-104 as a first-line treatment for pancreatic ductal adenocarcinoma (PDAC) [3] - Preclinical data indicates that combining IMM-1-104 with established chemotherapy regimens results in deeper and more durable tumor growth inhibition compared to either treatment alone [4] Company Updates - The company reported a cash position of $59.7 million as of June 30, 2024, down from $85.7 million at the end of 2023 [5] - Research and Development (R&D) expenses for Q2 2024 were $10.7 million, an increase from $9.5 million in Q2 2023, primarily due to higher clinical costs [6] - General and Administrative (G&A) expenses for Q2 2024 were $4.3 million, up from $4.0 million in the same period last year, attributed to increased stock-based compensation [7] Financial Performance - The net loss 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 [8] - The company expects its cash runway to be sufficient to fund operations into the second half of 2025 based on current cash and operating plans [9]

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 ...

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 ...