MiNK Reports Second Quarter 2024 Results and Business Update

Rhea-AI Summary

MiNK Therapeutics (NASDAQ: INKT) reported Q2 2024 results and provided a business update. Key highlights include:

• Expanded access to AgenT-797 in severe ARDS shows clinical efficacy
• Phase 2 study in 2L gastric cancer advancing with early data expected soon
• Phase 1 study in GvHD on track for activation in Q2 2024
• Successful PIPE financing raised $5.8 million at 25% premium
• Cash runway extended into 2025
• Q2 net loss of $2.7 million ($0.07 per share), down from $6.2 million ($0.18 per share) in Q2 2023
• Cash balance of $9.3 million as of June 30, 2024

MiNK is advancing its iNKT cell therapy programs, with promising results in ARDS and plans to fast-track IND filing for MiNK-215 CAR-iNKT therapy to early 2025.

Positive

• Expanded access to AgenT-797 in ARDS shows clinical efficacy with rapid cytokine reduction and patient improvement
• Successful PIPE financing raised $5.8 million at 25% premium
• Cash runway extended into 2025
• Net loss decreased from $6.2 million in Q2 2023 to $2.7 million in Q2 2024
• Cash used in operations reduced from $2.6 million in Q1 2024 to $2.3 million in Q2 2024

Negative

• Net loss of $2.7 million for Q2 2024
• Cash balance of $9.3 million as of June 30, 2024, which may limit future operations without additional funding

Financial Analyst

MiNK Therapeutics' Q2 2024 results reveal a mixed financial picture. The company's cash position improved to $9.3 million, bolstered by a $5.8 million PIPE financing at a 25% premium. However, the net loss of $2.7 million for the quarter, while reduced from the previous year, still indicates ongoing financial challenges. The reduction in cash burn to $2.3 million from $2.6 million in Q1 is positive, but sustainability remains a concern. The extended cash runway into 2025 provides some breathing room, but additional funding may be necessary to support ongoing clinical programs and preclinical advancements.

Oncology Researcher

The progress in MiNK's clinical programs is encouraging, particularly in ARDS and gastric cancer. The expanded access data for agenT-797 in ARDS, presented at the ATS 2024 meeting, shows promising results in immune-compromised patients. The rapid advancement of the Phase 2 study in 2L gastric cancer at Memorial Sloan Kettering is noteworthy, with early signals of activity. However, it's important to note that these are early-stage results and more robust data will be needed to fully assess the therapy's potential. The planned Phase 1 study in GvHD and the preclinical progress of MiNK-215 for solid tumors demonstrate a diverse pipeline, but clinical validation is still pending for these programs.

Biotech Industry Analyst

MiNK's focus on iNKT cell therapies positions it in a unique niche within the competitive cell therapy landscape. The company's strategy to advance agenT-797 through externally funded trials is cost-effective but may limit control over development. The planned IND filing for MiNK-215 in early 2025 shows pipeline progression, but timelines in biotech are often subject to delays. The reduction in operating expenses is positive for cash conservation, but it's essential to ensure this doesn't compromise research progress. While MiNK shows promise, investors should be aware that the company is still in early clinical stages and significant milestones and potential commercialization are likely years away.

• Expanded Access to AgenT-797 in Severe ARDS Reinforces Clinical Efficacy; Data Highlighted at ATS 2024 Annual Meeting
• Phase 2 Study in 2L Gastric Cancer Advances; Early Clinical Data to be Presented at Upcoming Medical Conference
• Phase 1 Study in GvHD on Track for Activation in 2Q 2024
  

NEW YORK, Aug. 13, 2024 (GLOBE NEWSWIRE) -- MiNK Therapeutics, Inc. (NASDAQ: INKT), a clinical-stage biopharmaceutical company pioneering the discovery, development, and commercialization of allogeneic, off-the-shelf, invariant natural killer T (iNKT) cell therapies to treat cancer and other immune-mediated diseases, today announced results for the second quarter 2024. MiNK executives will host a conference call and webcast at 8:30 a.m. ET to discuss the results and provide a corporate update.

"MiNK is making significant strides in advancing our iNKT programs as we pioneer this next generation of cell therapies for patients," said Dr. Jennifer Buell, CEO of MiNK Therapeutics. "Our lead program, agenT-797, is moving forward in a Phase 2 study for second-line gastric cancer, and we are fast-tracking IND-enabling activities for our FAP-expressing CAR-iNKT therapy, MiNK-215. Additionally, the expanded findings presented at the ATS annual meeting underscore the significant potential of agenT-797 in treating severe respiratory conditions in immune-compromised patients. We are committed to expanding the development of agenT-797 in a non-dilutive manner, particularly in the areas of ARDS and GvHD, where unmet needs are critical."

Business Updates:

• In May 2024, MiNK successfully closed a private placement financing (PIPE) agreement, raising $5.8 million at a 25% premium to a new investor. Increased efficiency and progress of externally funded trials enable cash runway into 2025.
  

Clinical Programs:

• Acute Respiratory Distress (ARDS): Expanded access to agenT-797 in ARDS has deepened observations of clinical benefit. MiNK’s recent presentation at the American Thoracic Society (ATS) 2024 annual meeting highlighted the activity of agenT-797 in treating ARDS. In a clinical case involving a renal transplant patient with severe COVID-19-induced respiratory distress, agenT-797 led to rapid cytokine reduction, successful extubation, and rapid discharge after just a single dose. These results underscore the potential of agenT-797 for severe respiratory conditions in immune-compromised patients. MiNK is committed to advancing agenT-797 in ARDS through a predominantly externally funded, large-scale platform trial.
• 2L Gastric Cancer: A Phase 2 Investigator-Sponsored Study of agenT-797 is progressing rapidly at Memorial Sloan Kettering Cancer Center (NCT06251973). The study’s swift advancement and early signals of activity highlight the promising potential of agenT-797 in treating challenging cancers, with initial data at an upcoming conference.
• MiNK is preparing to initiate a Phase 1 study of agenT-797 in Graft-versus-Host Disease (GvHD), with activation planned for 2Q 2024. This study aims to explore the potential of agenT-797 in mitigating GvHD, a severe and life-threatening complication following allogeneic stem cell transplantation. The unique immunomodulatory properties of iNKT cells offer a novel therapeutic approach to controlling GvHD by reducing inflammation and promoting immune tolerance - furthering MiNK’s commitment to the application of agenT-797 beyond cancer.
  

Preclinical Programs Advancing:

• MiNK-215 is an investigational IL-15 armored fibroblast activation protein (FAP) targeting CAR-iNKT cell therapy, that has demonstrated robust preclinical activity in solid tumor cancers, including MSS colorectal cancer liver metastases, and non-small-cell-lung cancer. Plans are in place to fast-track the IND filing to early 2025.
  

Financial Results

MiNK ended the quarter with a cash balance of $9.3 million reflecting cash used in operations for the quarter of $2.3 million, reduced from $2.6 million for the first quarter 2024.

Net loss for the three and six months ended June 30, 2024, was $2.7 million, or $0.07 per share, and $6.5 million, or $0.18 per share, respectively. This compares to $6.2 million, or $0.18 per share, and $11.9 million, or $0.35 per share, for the same periods in 2023.

Summary Consolidated Financial Information
Condensed Consolidated Balance Sheet Data
(in thousands)
(unaudited)
	June 30, 2024				December 31, 2023
Cash and cash equivalents	$	9,314			$	3,367
Total assets		10,324				4,552
Other Financial Information
(in thousands)
(unaudited)
	Three months ended June 30,								Six months ended June 30,
		2024				2023				2024				2023
Cash used in operations	$	2,291			$	4,151			$	4,833			$	8,517
Non-cash operating expenses		491				683				1,141				1,650
Condensed Consolidated Statements of Operations Data
(in thousands, except per share data)
(unaudited)
	Three months ended June 30,								Six months ended June 30,
		2024				2023				2024				2023
Operating expenses:
Research and development	$	1,840			$	4,558			$	4,389			$	8,752
General and administrative		1,062				1,785				2,343				3,445
Change in fair value of related party note		169				-				169				-
Operating loss		3,071				6,343				6,901				12,197
Other income, net		(369	)			(146	)			(386	)			(314	)
Net loss	$	2,702			$	6,197			$	6,515			$	11,883
Per common share data, basic and diluted:
Net loss	$	(0.07	)		$	(0.18	)		$	(0.18	)		$	(0.35	)
Weighted average number of common shares outstanding, basic and diluted		37,142				34,409				35,892				34,189

Conference Call

Dial-in numbers: 646-307-1963 (New York), 800-715-9871 (USA & Canada).
Conference ID: 4021545

Webcast

A live webcast and replay of the conference call will be accessible from the Events & Presentations page of the Company’s website at https://investor.minktherapeutics.com/events-and-presentations and via https://edge.media-server.com/mmc/p/gwzqgg8t/.

About MiNK Therapeutics

MiNK Therapeutics is a clinical-stage biopharmaceutical company pioneering the discovery, development, and commercialization of allogeneic invariant natural killer T (iNKT) cell therapies to treat cancer and other immune-mediated diseases. MiNK is advancing a pipeline of both native and next generation engineered iNKT programs, with a platform designed to facilitate scalable and reproducible manufacturing for off-the-shelf delivery. The company is headquartered in New York, NY. For more information, visit https://minktherapeutics.com/ or @MiNK_iNKT. Information that may be important to investors will be routinely posted on our website and social media channels.

Forward Looking Statements

This press release contains forward-looking statements that are made pursuant to the safe harbor provisions of the federal securities laws, including statements regarding the therapeutic and curative potential of agenT-797 and iNKT cells the mechanism of action, potency and safety, interim or top-line data, including statements regarding clinical data of agenT-797, the anticipated benefits of agenT-797 and clinical development plans and timelines. These forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially. These forward-looking statements are subject to risks and uncertainties, including the factors described under the Risk Factors section of the most recent Form 10-K filed with the SEC. MiNK cautions investors not to place considerable reliance on the forward-looking statements contained in this release. These statements speak only as of the date of this press release, and MiNK undertakes no obligation to update or revise the statements, other than to the extent required by law. All forward-looking statements are expressly qualified in their entirety by this cautionary statement.

Investor Contact

917-362-1370

investor@minktherapeutics.com

Media Contact

781-674-4428

communications@minktherapeutics.com

FAQ

What were MiNK Therapeutics' (INKT) Q2 2024 financial results?

MiNK Therapeutics reported a net loss of $2.7 million ($0.07 per share) for Q2 2024, compared to $6.2 million ($0.18 per share) in Q2 2023. The company ended the quarter with a cash balance of $9.3 million.

What progress has MiNK Therapeutics (INKT) made with AgenT-797 in ARDS?

Expanded access to AgenT-797 in ARDS has shown clinical efficacy, with a recent case study demonstrating rapid cytokine reduction, successful extubation, and rapid discharge after a single dose in a renal transplant patient with severe COVID-19-induced respiratory distress.

What is the status of MiNK Therapeutics' (INKT) Phase 2 study in gastric cancer?

MiNK's Phase 2 Investigator-Sponsored Study of agenT-797 in second-line gastric cancer is progressing rapidly at Memorial Sloan Kettering Cancer Center. Early signals of activity have been observed, with initial data expected to be presented at an upcoming conference.

When does MiNK Therapeutics (INKT) expect to initiate its Phase 1 study in GvHD?

MiNK Therapeutics is preparing to initiate a Phase 1 study of agenT-797 in Graft-versus-Host Disease (GvHD), with activation planned for Q2 2024.