Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 _________________________________________________ FORM 10-Q _________________________________________________ (Mark One) x QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2024 or o TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _____________ to Commission File Num ...

- 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 ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 _________________________________________________ FORM 10-Q _________________________________________________ (Mark One) x QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2024 or o TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _____________ to Commission File Number: ...

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]

- 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 ...

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 ...