IGM Biosciences Announces Fourth Quarter and Full Year 2023 Financial Results and Provides Corporate Update

Rhea-AI Summary

IGM Biosciences, Inc. (IGMS) announces financial results for Q4 and full year 2023, highlighting progress in clinical development of lead product candidates. The company provides updates on aplitabart and imvotamab trials, with promising enrollment and data expectations. Financially, the company reports cash and investments of $337.7 million, collaboration revenues of $2.1 million, R&D expenses of $215.5 million, and a net loss of $246.4 million for 2023. IGM anticipates full year 2024 operating expenses of $210-$220 million and collaboration revenue of $3 million, aiming to maintain a cash balance of $180 million to support operations until Q2 2026.

Positive

• IGM Biosciences, Inc. reports financial results for Q4 and full year 2023.
• Significant progress made in clinical development of lead product candidates.
• Updates provided on aplitabart and imvotamab trials with encouraging enrollment.
• Company's financials show cash and investments of $337.7 million and collaboration revenues of $2.1 million for 2023.
• IGM anticipates 2024 operating expenses of $210-$220 million and collaboration revenue of $3 million.
• Company aims to maintain a cash balance of $180 million to support operations until Q2 2026.

Negative

• Net loss increased in 2023 compared to 2022.
• R&D expenses rose to $215.5 million in 2023.
• Collaboration revenue saw a slight increase from 2022 to 2023.
• Operating expenses for 2024 are expected to be high, with a significant portion allocated to non-cash stock-based compensation.
• Cash balance projected to decrease by the end of 2024.

Financial Analyst

The financial results presented by IGM Biosciences, Inc. indicate a trajectory of increased investment into research and development (R&D), with a year-over-year increase from $179.3 million to $215.5 million. This uptick reflects a strategic emphasis on advancing the company's clinical pipeline, particularly their lead product candidates aplitabart and imvotamab. The increased R&D spend, however, has resulted in a widened net loss, from $221.1 million ($5.32 per share) in the previous year to $246.4 million ($4.71 per share) in 2023. Despite this, the loss per share has decreased due to an increase in the number of shares outstanding, which may dilute shareholder value.

From an investment perspective, the company's guidance for the fiscal year 2024 suggests a slight reduction in operating expenses and a modest increase in collaboration revenue. The projected year-end cash and investments balance of approximately $180 million, with runway into Q2 2026, provides a cushion for continued operations but also signals the need for careful cash management as the company moves forward with its clinical trials.

The stock market generally reacts to such financials with caution, as the increased R&D spending without immediate revenue growth presents a risk. However, successful clinical trial outcomes could significantly alter the company's valuation, making it a speculative play for investors with a high-risk tolerance.

Medical Research Analyst

The clinical advancements of IGM Biosciences in developing engineered IgM antibodies are noteworthy, particularly the progression of aplitabart in a randomized clinical trial for second-line metastatic colorectal cancer. The focus on progression-free survival (PFS) as a primary endpoint is a critical measure of clinical benefit, as it indicates the length of time during and after treatment that a patient lives with the disease without it getting worse. The company's optimism regarding the enrollment and potential outcomes of these trials indicates confidence in aplitabart's therapeutic potential.

Furthermore, the initiation of Phase 1b clinical trials for imvotamab in severe systemic lupus erythematosus and rheumatoid arthritis and the FDA clearance for its use in idiopathic inflammatory myopathies, suggest a broadening of the company's therapeutic scope. These developments could have significant implications for patients with these autoimmune diseases, as new treatment options are in high demand.

However, the clinical success of these candidates is not guaranteed and investors should be aware of the inherent risks associated with clinical-stage biotechnology firms. The results of these trials will be pivotal in determining the company's future, both scientifically and financially.

Market Research Analyst

The strategic expansion of IGM Biosciences' clinical trial sites across the United States, Asia and Europe for its lead product candidate aplitabart demonstrates the company's intent to establish a global footprint in the oncology market. This geographical diversification can potentially expedite patient enrollment and facilitate market penetration in different regions upon successful drug approval.

Moreover, the company's collaboration with Sanofi, as indicated by the expected collaboration revenue, suggests a partnership that could provide both financial support and strategic advantages in drug development and commercialization. Such collaborations are common in the biotech industry, often providing smaller companies with necessary resources and larger companies with innovative product pipelines.

Overall, the company's financial guidance and pipeline updates provide a mixed picture. While the cash runway projection into 2026 offers some assurance of stability, the reliance on the success of ongoing clinical trials for future growth is a significant variable that could impact the company's market position and investor sentiment.

MOUNTAIN VIEW, Calif., March 07, 2024 (GLOBE NEWSWIRE) -- IGM Biosciences, Inc. (Nasdaq: IGMS), a clinical-stage biotechnology company creating and developing engineered IgM antibodies, today announced its financial results for the fourth quarter and full year ended December 31, 2023 and provided an update on recent developments.

“We made significant progress during 2023 in the clinical development of our two lead product candidates in therapeutic areas that we believe have the greatest potential to produce significant near-term value,” said Fred Schwarzer, Chief Executive Officer of IGM Biosciences. “Enrollment in our randomized clinical trial of aplitabart plus FOLFIRI and bevacizumab in second-line metastatic colorectal cancer continues to be encouraging, and we expect to expeditiously complete our target enrollment of 110 patients. If the control arm of this randomized study demonstrates the expected median progression free survival of approximately six months, we will be able to begin evaluating the benefit of aplitabart in enhancing progression free survival by the end of this year."

Mr. Schwarzer continued, “We also initiated two Phase 1b clinical trials of imvotamab in severe systemic lupus erythematosus and in severe rheumatoid arthritis. We are encouraged by the initial level of investigator and patient interest that we have seen in these clinical trials, and we are optimistic that we will be able to generate meaningful initial clinical data by the end of 2024.”

Pipeline Updates

Aplitabart (DR5 agonist)

• Clinical development of aplitabart advances.
  • Enrollment ongoing in randomized colorectal cancer clinical trial. The Company continues to enroll patients in a randomized clinical trial of aplitabart, a death receptor 5 agonist, plus FOLFIRI and bevacizumab in second-line metastatic colorectal cancer. In addition to clinical trial sites in the United States, this study includes multiple clinical trial sites in Asia and Europe. This randomized trial is designed to assess the additional benefit of 3 mg/kg of aplitabart when administered in combination with the current standard of care treatment arm of FOLFIRI and bevacizumab, with a primary endpoint of progression-free survival (PFS).
  • Evaluating 10 mg/kg dose in single arm colorectal cancer clinical trial. The Company also continues to evaluate a dose of 10 mg/kg of aplitabart in combination with FOLFIRI and bevacizumab in the treatment of later line colorectal cancer patients in its single arm combination clinical trial. The Company expects to complete enrollment of patients in this 10 mg/kg single arm combination dose cohort in the first half of 2024.
    

Imvotamab (CD20 x CD3)

• Clinical development of imvotamab in autoimmune diseases advances. The Company currently has two Phase 1b clinical trials underway for imvotamab, an IgM-based CD20 x CD3 bispecific T cell engaging antibody: one in severe systemic lupus erythematosus (SLE) and one in severe rheumatoid arthritis (RA). These clinical trials are being expanded to include multiple U.S. and international clinical trial sites. The Company also received clearance in late 2023 from the FDA of its IND application for the use of imvotamab in treating idiopathic inflammatory myopathies (myositis), and the Company is currently making preparations to initiate this clinical trial.
  

IGM-2644 (CD38 x CD3)

• Clinical development of IGM-2644 in autoimmune diseases to be initiated. The Company is currently making plans to begin clinical development of IGM-2644, a CD38 x CD3 T cell engager antibody, in the treatment of autoimmune diseases.
  

Fourth Quarter and Full Year 2023 Financial Results

• Cash and Investments: Cash and investments as of December 31, 2023 were $337.7 million, compared to $427.2 million as of December 31, 2022.
• Collaboration Revenue: For the fourth quarter and year ended 2023, collaboration revenues were $0.7 million and $2.1 million, respectively, compared to $0.4 million and $1.1 million for the fourth quarter and year ended 2022, respectively.
• Research and Development (R&D) Expenses: For the fourth quarter and year ended 2023, R&D expenses were $54.2 million and $215.5 million, respectively, compared to $45.0 million and $179.3 million for the fourth quarter and year ended 2022, respectively.
• General and Administrative (G&A) Expenses: For the fourth quarter and year ended 2023, G&A expenses were $11.6 million and $50.1 million, respectively, compared to $11.6 million and $49.7 million for the fourth quarter and year ended 2022, respectively.
• Net Loss: For the fourth quarter of 2023, net loss was $60.7 million, or a loss of $1.01 per share, compared to a net loss of $52.6 million, or a loss of $1.19 per share, for the fourth quarter of 2022. For the year ended 2023, net loss was $246.4 million, or a loss of $4.71 per share, compared to a net loss of $221.1 million, or a loss of $5.32 per share, for the year ended 2022.
  

2024 Financial Guidance

The Company expects full year 2024 GAAP operating expenses of $210 million to $220 million, including estimated non-cash stock-based compensation expense of approximately $40 million, and full year collaboration revenue of approximately $3 million related to the Sanofi agreement. The Company expects to end 2024 with a balance of approximately $180 million in cash and investments, and for the balance to enable it to fund its operating expenses and capital expenditure requirements into the second quarter of 2026.

About IGM Biosciences, Inc.

IGM Biosciences is a clinical-stage biotechnology company committed to developing and delivering a new class of medicines to treat patients with cancer and autoimmune and inflammatory diseases. IGM’s pipeline of clinical and preclinical assets is based on the IgM antibody, which has 10 binding sites compared to conventional IgG antibodies with only 2 binding sites. IGM also has an exclusive worldwide collaboration agreement with Sanofi to create, develop, manufacture, and commercialize IgM antibody agonists against oncology and immunology and inflammation targets. For more information, please visit www.igmbio.com.

Cautionary Note Regarding Forward-Looking Statements

This press release contains forward-looking statements. Such forward-looking statements are not based on historical fact and include, but are not limited to: the potential of, and expectations regarding, IGM’s technology platform and its IgM antibodies and product candidates, including aplitabart, imvotamab, and IGM-2644; IGM’s plans and expectations regarding its clinical development efforts and activities; statements regarding the clinical development of aplitabart, imvotamab, and IGM-2644, including the timing of clinical trial initiation and patient enrollment; IGM’s expectations regarding its financial position and guidance, including non-cash stock-based compensation expense, collaboration revenue, ending 2024 cash and investments and projected cash runway; and statements by IGM’s Chief Executive Officer. Such statements are subject to numerous important factors, risks and uncertainties that may cause actual events or results to differ materially, including but not limited to: IGM’s early stages of clinical drug development; risks related to the use of engineered IgM antibodies, which is a novel and unproven therapeutic approach; IGM’s ability to demonstrate the safety and efficacy of its product candidates; IGM’s ability to successfully and timely advance its product candidates through clinical trials; IGM’s ability to enroll patients in its clinical trials; the potential for the results of clinical trials to differ from preclinical, preliminary, initial or expected results; the risk of significant adverse events, toxicities or other undesirable side effects; the risk of the occurrence of any event, change or other circumstance that could give rise to the termination of collaborations with third parties; IGM’s ability to successfully manufacture and supply its product candidates for clinical trials; the potential impact of continuing or worsening supply chain constraints; the risk that all necessary regulatory approvals cannot be obtained; the potential market for IGM’s product candidates, and the progress and success of alternative therapeutics currently available or in development; IGM’s ability to obtain additional capital to finance its operations; uncertainties related to the projections of the size of patient populations suffering from the diseases IGM is targeting; IGM’s ability to obtain, maintain and protect its intellectual property rights; developments relating to IGM’s competitors and its industry, including competing product candidates and therapies; any potential delays or disruptions resulting from catastrophic events, including epidemics or other outbreaks of infectious disease; general economic and market conditions, including inflation; and other risks and uncertainties, including those more fully described in IGM’s filings with the Securities and Exchange Commission (SEC), including IGM’s Annual Report on Form 10-K filed with the SEC on March 7, 2024 and in IGM’s future reports to be filed with the SEC. Any forward-looking statements contained in this press release speak only as of the date hereof, and IGM specifically disclaims any obligation to update any forward-looking statement, except as required by law.

Contact
Argot Partners
David Pitts
212-600-1902
igmbio@argotpartners.com

IGM Biosciences, Inc.
Selected Statement of Operations Data
(in thousands, except share and per share data)
		Three Months Ended								Twelve Months Ended
		December 31,								December 31,
			2023				2022				2023				2022
Collaboration revenue		$	651			$	372			$	2,130			$	1,069
Operating expenses:
Research and development (1)			54,190				45,018				215,519				179,289
General and administrative (1)			11,580				11,618				50,072				49,736
Total operating expenses			65,770				56,636				265,591				229,025
Loss from operations			(65,119	)			(56,264	)			(263,461	)			(227,956	)
Other income (expense)
Interest income			4,666				3,746				17,743				7,035
Other expense			—				(58	)			(20	)			(181	)
Total other income (expense)			4,666				3,688				17,723				6,854
Loss before income tax expense			(60,453	)			(52,576	)			(245,738	)			(221,102	)
Income tax expense			(242	)			—				(678	)			—
Net Loss		$	(60,695	)		$	(52,576	)		$	(246,416	)		$	(221,102	)
Net loss per share, basic and diluted		$	(1.01	)		$	(1.19	)		$	(4.71	)		$	(5.32	)
Weighted-average common shares outstanding, basic and diluted			59,829,077				44,241,491				52,311,958				41,543,954
(!)Amounts include stock-based compensation expense as follows:
Research and development		$	5,421			$	6,582			$	27,499			$	25,620
General and administrative			3,816				4,527				19,048				19,090
Total stock-based compensation expense		$	9,237			$	11,109			$	46,547			$	44,710

IGM Biosciences, Inc.
Selected Balance Sheet Data
(in thousands)
		December 31,
			2023				2022
Cash and investments		$	337,677			$	427,162
Total assets			423,411				513,499
Accounts payable			1,326				2,512
Accrued liabilities			31,544				33,621
Deferred revenue			146,801				148,931
Total liabilities			220,177				226,236
Accumulated deficit			(821,242	)			(574,826	)
Total stockholders' equity			203,234				287,263

What are the financial results reported by IGM Biosciences, Inc. for Q4 and full year 2023?

IGM Biosciences, Inc. reported cash and investments of $337.7 million, collaboration revenues of $2.1 million, R&D expenses of $215.5 million, and a net loss of $246.4 million for 2023.

What updates did IGM Biosciences provide on aplitabart and imvotamab trials?

IGM Biosciences provided updates on aplitabart trials in colorectal cancer and imvotamab trials in severe systemic lupus erythematosus and severe rheumatoid arthritis, highlighting encouraging enrollment and data expectations.

What are the 2024 financial guidance details provided by IGM Biosciences?

IGM Biosciences expects full year 2024 operating expenses of $210-$220 million, collaboration revenue of $3 million, and aims to maintain a cash balance of $180 million to support operations until Q2 2026.