Marker Therapeutics Studies Fiscal Yr 2022 Company and Monetary Outcomes

2022 CLINICAL AND REGULATORY HIGHLIGHTS

• Awarded $2 million grant from U.S. Meals and Drug Administration (FDA) for the Part 2 ARTEMIS trial of MT-401 in post-transplant acute myeloid leukemia (AML)
• Investigational New Drug (IND) software cleared by FDA for multicenter Part 1 trial of MT-601 for the therapy of metastatic pancreatic most cancers together with front-line chemotherapy
  • Obtained FDA Orphan Drug Designation for MT-601 for the therapy of pancreatic most cancers
• IND for MT-601 for the therapy of non-Hodgkin lymphoma cleared by FDA, centered on sufferers who’ve failed or are ineligible for CAR-T remedy

2022 CORPORATE AND FINANCIAL HIGHLIGHTS

• Entered right into a companies settlement with Wilson Wolf Manufacturing Company, which included an $8.0 million upfront money cost from Wilson Wolf
• Entered into a typical inventory buy settlement with Lincoln Park Capital for as much as $25 million

HOUSTON, March 22, 2023 (GLOBE NEWSWIRE) — Marker Therapeutics, Inc. (Nasdaq: MRKR), a clinical-stage immuno-oncology firm specializing in creating next-generation T cell-based immunotherapies for the therapy of hematological malignancies and stable tumor indications, at present reported fiscal 12 months 2022 monetary outcomes and offered updates for its medical improvement applications.

“2022 was a important 12 months for Marker Therapeutics as we superior the corporate on a number of fronts, together with key enhancements to our multiTAA medical improvement pipeline and strategic initiatives, together with with Wilson Wolf, to leverage our differentiated manufacturing capabilities to generate different sources of funding for our medical applications,” mentioned Peter L. Hoang, President and Chief Government Officer at Marker Therapeutics. “We consider these initiatives will unlock a number of worth constructing alternatives for Marker all through 2023. We proceed to advance our MT-401 Part 2 ARTEMIS medical trial and are inspired by latest knowledge involving measurable residual illness (MRD) optimistic sufferers, which recommend MT-401 produced with our new T cell manufacturing course of might be properly fitted to this underserved subset of sufferers with AML. We anticipate reporting a extra expansive knowledge readout from the MRD optimistic group within the second half of 2023.”

Mr. Hoang continued: “We additionally made appreciable progress with our MT-601 program, securing FDA clearance for INDs in non-Hodgkin lymphoma and pancreatic most cancers. Now we have initiated enrollment for the lymphoma Part 1 medical examine of MT-601 and count on to report topline knowledge in early 2024 and count on to provoke enrollment for the pancreatic examine by the fourth quarter of 2023. We proceed to be energized by the manufacturing companies settlement with Wilson Wolf and consider we’re on observe to earn the extra $1 million bonus offered for within the settlement. Moreover, we see the potential to construct on the success of this undertaking with extra revenue-generating alternatives whereby we leverage our distinctive experience in technical operations to offer the corporate with non-dilutive capital to fund our medical applications.”

MT-401 PHASE 2 ARTEMIS (AML)

New manufacturing course of for MT-401:

• In 2022, Marker applied an improved manufacturing course of that decreased manufacturing time to 9 days (in comparison with the unique means of >30 days).
• This new course of enabled a >90% discount within the variety of operator interventions throughout manufacturing and an improved ultimate T cell product candidate in comparison with the unique product candidate that was used within the ongoing ARTEMIS trial.
• These course of enhancements have yielded an MT-401 product candidate that has 5 occasions the measurable specificity and 4 occasions the efficiency when it comes to tumor killing as in comparison with the prior manufacturing course of. Marker has now handled 12 sufferers with MT-401 manufactured utilizing the Firm’s improved course of, with 16 sufferers handled with MT-401 manufactured utilizing the unique course of, for a complete of 28 sufferers.

Adjuvant Sufferers:

• Thus far, a complete of 11 sufferers within the adjuvant arm of the ARTEMIS examine have been randomized to therapy with MT-401 utilizing a brand new manufacturing course of or to standard-of-care.
• All sufferers are too early for analysis, however the Information Monitoring Committee has reviewed the present security knowledge and has not recognized any issues.

Marker continues to see promising knowledge with MRD+ sufferers:

• A complete of 4 sufferers with measurable residual illness (MRD+) have been handled and are at present evaluable.
  • Two MRD+ sufferers had been handled with MT-401 manufactured utilizing the unique manufacturing course of and confirmed elimination of detectable illness.
• On this replace, Marker can report on the standing of two extra MRD+ sufferers that had been handled with MT-401 manufactured with the improved course of:
  • The primary MRD+ affected person was handled at 100 x 10⁶ cells per infusion and was capable of stay in secure illness for six months, permitting the affected person to bridge to a second allogeneic transplant.
  • The second MRD+ affected person was dosed at 200 x 10⁶ cells per infusion and the PCR worth, which proved to be a precious device for detecting MRD, has decreased by 70% solely 4 weeks after the final infusion. This affected person’s illness standing will proceed to be intently monitored and evaluated.
• Marker additionally handled one extra MRD+ affected person with product manufactured utilizing the improved course of. This affected person is simply too early for analysis. Extra MRD+ sufferers have been enrolled and are awaiting therapy.
• Marker anticipates reporting a knowledge readout of the MRD+ affected person subset within the second half of 2023.

Measurable residual illness is a crucial biomarker in hematological malignancies, akin to AML, that’s used for prognostic, predictive and monitoring assessments. This time period refers to a small variety of malignant most cancers cells remaining in a affected person’s physique after completion of remedy, regardless of the absence of medical and radiological proof of illness. MRD detection depends on extremely delicate laboratory strategies, akin to next-generation sequencing, polymerase chain response (PCR), or circulation cytometry. The evaluation is essential in AML administration as it may present prognostic data and information therapeutic choices, akin to the necessity for added therapy or shut surveillance. Importantly, MRD is a transitional part previous to improvement of frank relapse and regarded a adverse prognostic issue. Thus, the achievement of MRD negativity, outlined because the absence of detectable malignant cells, is a positive prognostic issue and an necessary therapy purpose in AML.

The usual first-line therapy for the final decade had been mixture chemotherapy utilizing cytarabine and an anthracycline. Nevertheless, roughly half of the sufferers ultimately relapse. Eligible sufferers subsequently proceed to hematopoietic stem cell transplantation (HSCT), however illness relapse after transplant is frequent and stays a serious explanation for loss of life. Thus far, there isn’t any authorized remedy for post-transplant MRD+ sufferers, highlighting the necessity for novel therapies. Subsequently, the optimistic medical responses noticed in MRD+ sufferers handled with MT-401 could present a more practical strategy to therapy.

“Our ARTEMIS trial confirmed promising medical responses in post-transplant MRD optimistic sufferers highlighting the potential advantage of our multiTAA-specific T cell remedy in sufferers the place no therapies have been authorized,” mentioned Dr. Juan F. Vera, Chief Scientific Officer and Chief Working Officer of Marker Therapeutics. “We’ll proceed to trace the sufferers’ illness standing and sit up for investigating MT-401 in a bigger affected person inhabitants.”

Dr. Vera continued: “Our improved T cell manufacturing course of used for multiTAA-specific T cells allows a 9-day ex vivo T cell manufacturing, offering a quick turnaround for affected person therapy to achieve MRD optimistic sufferers earlier than relapse.”

Frank Relapse Sufferers:

• Thus far, a complete of 15 frank relapse sufferers have been handled.
• Along with the 11 sufferers beforehand reported, who had been handled with MT-401 manufactured utilizing the unique manufacturing course of, 4 extra sufferers with frank relapse have been handled with MT-401 manufactured utilizing the improved manufacturing course of:
  • Of the 4 sufferers handled with the improved manufacturing course of, one among these sufferers obtained a dose of 100 x 10⁶ cells per infusion, whereas the opposite three sufferers had been dosed at 200 x 10⁶ cells per infusion.
  • Not one of the frank relapse sufferers confirmed an goal response to remedy. 
• Marker has suspended additional enrollment of frank relapse sufferers whereas re-evaluating extra modifications for this affected person cohort, together with doubtlessly increased cell doses.

MT-601 (Lymphoma)

• IND cleared by FDA for the multicenter Part 1 trial of MT-601 for the therapy of sufferers with non-Hodgkin lymphoma
• Part 1 medical trial initiated in Q1 2023 with a medical readout anticipated within the first quarter of 2024

MT-601 (Pancreatic):

• IND cleared by FDA for the multicenter Part 1 trial of MT-601 for the therapy of sufferers with metastatic pancreatic most cancers together with front-line chemotherapy
• Part 1 medical trial anticipated to provoke by This autumn 2023.

FISCAL YEAR 2022 FINANCIAL RESULTS

Money Place and Steering: At December 31, 2022, Marker had money and money equivalents of $11.8 million. The Firm believes that its current money, money equivalents and restricted money will fund its working bills and capital expenditure necessities into the third quarter of 2023.

R&D Bills: Analysis and improvement bills had been $26.1 million for the 12 months ended December 31, 2022, in comparison with $27.8 million for the 12 months ended December 31, 2021.

G&A Bills: Normal and administrative bills had been $12.8 million for the 12 months ended December 31, 2022, in comparison with $12.9 million for the 12 months ended December 31, 2021.

Internet Loss: Marker reported a internet lack of $29.9 million for the 12 months ended December 31, 2022, in comparison with a internet lack of $41.9 million for the 12 months ended December 31, 2021.  

About Marker’s Part 2 ARTEMIS Trial

The multicenter Part 2 AML examine is evaluating the medical efficacy of MT-401 in sufferers with AML following an allogeneic stem-cell transplant in each the adjuvant and lively illness setting. Within the adjuvant setting, roughly 150 sufferers will probably be randomized 1:1 to both MT-401 at 90 days post-transplant versus standard-of-care remark, whereas roughly 40 sufferers with lively illness will obtain MT-401 as a part of the single-arm group.

The first aims of the trial are to guage relapse-free survival within the adjuvant group and decide the whole remission charge and length of full remission in lively illness sufferers. Extra aims embrace, for the adjuvant group, total survival and graft-versus-host illness relapse-free survival whereas extra aims for the lively illness group embrace total response charge, length of response, progression-free survival, and total survival.

About Marker Therapeutics, Inc.
Marker Therapeutics, Inc. is a clinical-stage immuno-oncology firm specializing within the improvement of next-generation T cell-based immunotherapies for the therapy of hematological malignancies and stable tumor indications. Marker’s cell remedy know-how is predicated on the selective enlargement of non-engineered, tumor-specific T cells that acknowledge tumor related antigens (i.e. tumor targets) and kill tumor cells expressing these targets. This inhabitants of T cells is designed to assault a number of tumor targets following infusion into sufferers and to activate the affected person’s immune system to provide broad spectrum anti-tumor exercise. As a result of Marker doesn’t genetically engineer its T cell therapies, we consider that our product candidates will probably be simpler and cheaper to fabricate, with decreased toxicities, in comparison with present engineered CAR-T and TCR-based approaches, and will present sufferers with significant medical profit. In consequence, Marker believes its portfolio of T cell therapies has a compelling product profile, as in comparison with present gene-modified CAR-T and TCR-based therapies.

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Ahead-Trying Statements

This launch incorporates forward-looking statements for functions of the protected harbor provisions of the Personal Securities Litigation Reform Act of 1995. Statements on this information launch regarding the Firm’s expectations, plans, enterprise outlook or future efficiency, and another statements regarding assumptions made or expectations as to any future occasions, situations, efficiency or different issues, are “forward-looking statements.” Ahead-looking statements embrace statements concerning our intentions, beliefs, projections, outlook, analyses or present expectations regarding, amongst different issues: our analysis, improvement and regulatory actions and expectations referring to our non-engineered multi-tumor antigen particular T cell therapies; the effectiveness of those applications or the attainable vary of software and potential healing results and security within the therapy of illnesses; the timing, conduct and success of our medical trials, together with the Part 2 trial of MT-401 and our deliberate trials of MT-401-OTS and MT-601; our means to make use of our manufacturing services to assist medical and business demand; the success of our new manufacturing course of and our collaboration with Wilson Wolf Manufacturing Company; and our future working bills and capital expenditure necessities. Ahead-looking statements are by their nature topic to dangers, uncertainties and different elements which might trigger precise outcomes to vary materially from these said in such statements. Such dangers, uncertainties and elements embrace, however will not be restricted to the dangers set forth within the Firm’s most up-to-date Kind 10-Ok, 10-Q and different SEC filings which can be found by EDGAR at WWW.SEC.GOV. Such dangers and uncertainties could also be amplified by the COVID-19 pandemic and its impression on our enterprise and the worldwide economic system. The Firm assumes no obligation to replace our forward-looking statements whether or not because of new data, future occasions or in any other case, after the date of this press launch.

 

Marker Therapeutics, Inc.
Consolidated Steadiness Sheets
(Audited)
	December 31,				December 31,
		2022				2021
ASSETS
Present property:
Money and money equivalents	$	11,782,172			$	42,351,145
Restricted money		–				1,146,186
Pay as you go bills and deposits		2,435,079				2,484,634
Different receivables		2,402,004				237
Whole present property		16,619,255				45,982,202
Non-current property:
Property, plant and tools, internet		12,323,143				10,096,861
Building in progress		–				2,225,610
Proper-of-use property, internet		5,479,786				9,830,461
Whole non-current property		17,802,929				22,152,932
Whole property	$	34,422,184			$	68,135,134
LIABILITIES AND STOCKHOLDERS’ EQUITY
Present liabilities:
Accounts payable and accrued liabilities	$	4,704,611			$	11,134,913
Associated occasion deferred income		2,500,000				–
Deferred income		–				1,146,186
Lease legal responsibility		577,198				620,490
Whole present liabilities		7,781,809				12,901,589
Non-current liabilities:
Lease legal responsibility, internet of present portion		7,039,338				11,247,950
Whole non-current liabilities		7,039,338				11,247,950
Whole liabilities		14,821,147				24,149,539
Stockholders’ fairness:
Most popular inventory – $0.001 par worth, 5 million shares approved and 0 shares issued and excellent at December 31, 2022 and 2021, respectively		–				–
Frequent inventory, $0.001 par worth, 30 million and 15 million shares approved, 8.4 million and eight.3 million shares issued and excellent as of December 31, 2022 and 2021, respectively		8,406				8,308
Extra paid-in capital		447,641,680				442,095,642
Collected deficit		(428,049,049	)			(398,118,355	)
Whole stockholders’ fairness		19,601,037				43,985,595
Whole liabilities and stockholders’ fairness	$	34,422,184			$	68,135,134

 

Marker Therapeutics, Inc.
Consolidated Statements of Operations
(Audited)
	For the Years Ended
	December 31,
		2022				2021
Revenues:
Grant revenue	$	3,513,544			$	1,241,710
Associated occasion service income		5,500,000				–
Whole revenues		9,013,544				1,241,710
Working bills:
Analysis and improvement		26,139,323				27,794,879
Normal and administrative		12,820,004				12,924,826
Whole working bills		38,959,327				40,719,705
Loss from operations		(29,945,783	)			(39,477,995	)
Different revenue (bills):
Arbitration settlement		(232,974	)			(2,406,576	)
Curiosity revenue		248,063				5,700
Internet loss	$	(29,930,694	)		$	(41,878,871	)
Internet loss per share, primary and diluted	$	(3.58	)		$	(5.47	)
Weighted common variety of frequent shares excellent, primary and diluted		8,351,003				7,650,567

Marker Therapeutics, Inc.
Condensed Consolidated Statements of Money Flows
(Audited)
	For the Years Ended
	December 31,
		2022				2021
Money Flows from Working Actions:
Internet loss	$	(29,930,694	)		$	(41,878,871	)
Reconciliation of internet loss to internet money utilized in working actions:
Depreciation and amortization		2,789,106				2,148,983
Inventory-based compensation		5,344,006				5,964,048
Amortization on right-of-use property		891,343				1,013,655
Loss on disposal of mounted property		25,995				–
Acquire on lease termination		(278,681	)			–
Adjustments in working property and liabilities:
Pay as you go bills and deposits		49,555				(426,710	)
Different receivables		(2,401,767	)			1,000,322
Accounts payable and accrued bills		(4,300,939	)			4,141,414
Associated occasion deferred income		2,500,000				–
Deferred income		(1,146,186	)			1,146,186
Lease legal responsibility		(513,891	)			(388,792	)
Internet money utilized in working actions		(26,972,153	)			(27,279,765	)
Money Flows from Investing Actions:
Buy of property and tools		(1,456,006	)			(1,572,161	)
Buy of development in progress		(3,489,130	)			(1,558,970	)
Internet money utilized in investing actions		(4,945,136	)			(3,131,131	)
Money Flows from Financing Actions:
Proceeds from issuance of frequent inventory, internet		202,130				52,552,758
Proceeds from train of inventory choices		–				3,087
Internet money offered by financing actions		202,130				52,555,845
Internet (lower) enhance in money, money equivalents and restricted money		(31,715,159	)			22,144,949
Money, money equivalents and restricted money at starting of the interval		43,497,331				21,352,382
Money, money equivalents and restricted money at finish of the interval	$	11,782,172			$	43,497,331

 

Contacts

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Media

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