Marker Therapeutics Studies Fiscal Yr 2022 Company and Monetary Outcomes
2022 CLINICAL AND REGULATORY HIGHLIGHTS
$2 milliongrant 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 millionupfront money cost from Wilson Wolf
- Entered into a typical inventory buy settlement with
Lincoln Park Capitalfor as much as $25 million
“2022 was a important 12 months for
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.
- 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.
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.
- 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
- 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
R&D Bills: Analysis and improvement bills had been
G&A Bills: Normal and administrative bills had been
Internet Loss: Marker reported a internet lack of
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.
To obtain future press releases by way of electronic mail, please go to: https://www.markertherapeutics.com/email-alerts.
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
|Consolidated Steadiness Sheets|
|Money and money equivalents||$||11,782,172||$||42,351,145|
|Pay as you go bills and deposits||2,435,079||2,484,634|
|Whole present property||16,619,255||45,982,202|
|Property, plant and tools, internet||12,323,143||10,096,861|
|Building in progress||–||2,225,610|
|Proper-of-use property, internet||5,479,786||9,830,461|
|Whole non-current property||17,802,929||22,152,932|
|LIABILITIES AND STOCKHOLDERS’ EQUITY|
|Accounts payable and accrued liabilities||$||4,704,611||$||11,134,913|
|Associated occasion deferred income||2,500,000||–|
|Lease legal responsibility||577,198||620,490|
|Whole present liabilities||7,781,809||12,901,589|
|Lease legal responsibility, internet of present portion||7,039,338||11,247,950|
|Whole non-current liabilities||7,039,338||11,247,950|
|Most popular inventory –
|Extra paid-in capital||447,641,680||442,095,642|
|Whole stockholders’ fairness||19,601,037||43,985,595|
|Whole liabilities and stockholders’ fairness||$||34,422,184||$||68,135,134|
|Consolidated Statements of Operations|
|For the Years Ended|
|Associated occasion service income||5,500,000||–|
|Analysis and improvement||26,139,323||27,794,879|
|Normal and administrative||12,820,004||12,924,826|
|Whole working bills||38,959,327||40,719,705|
|Loss from operations||(29,945,783||)||(39,477,995||)|
|Different revenue (bills):|
|Internet loss per share, primary and diluted||$||(3.58||)||$||(5.47||)|
|Weighted common variety of frequent shares excellent, primary and diluted||8,351,003||7,650,567|
|Condensed Consolidated Statements of Money Flows|
|For the Years Ended|
|Money Flows from Working Actions:|
|Reconciliation of internet loss to internet money utilized in working actions:|
|Depreciation and amortization||2,789,106||2,148,983|
|Amortization on right-of-use property||891,343||1,013,655|
|Loss on disposal of mounted property||25,995||–|
|Acquire on lease termination||(278,681||)||–|
|Adjustments in working property and liabilities:|
|Pay as you go bills and deposits||49,555||(426,710||)|
|Accounts payable and accrued bills||(4,300,939||)||4,141,414|
|Associated occasion deferred income||2,500,000||–|
|Lease legal responsibility||(513,891||)||(388,792||)|
|Internet money utilized in working actions||(26,972,153||)||(27,279,765||)|
|Money Flows from Investing Actions:|
|Buy of property and tools||(1,456,006||)||(1,572,161||)|
|Buy of development in progress||(3,489,130||)||(1,558,970||)|
|Internet money utilized in investing actions||(4,945,136||)||(3,131,131||)|
|Money Flows from Financing Actions:|
|Proceeds from issuance of frequent inventory, internet||202,130||52,552,758|
|Proceeds from train of inventory choices||–||3,087|
|Internet money offered by financing actions||202,130||52,555,845|
|Internet (lower) enhance in money, money equivalents and restricted money||(31,715,159||)||22,144,949|
|Money, money equivalents and restricted money at starting of the interval||43,497,331||21,352,382|
|Money, money equivalents and restricted money at finish of the interval||$||11,782,172||$||43,497,331|
2023 GlobeNewswire, Inc., supply
Technical evaluation tendencies MARKER THERAPEUTICS, INC.
|Quick Time period||Mid-Time period||Lengthy Time period|
Revenue Assertion Evolution
|Variety of Analysts||1|
|Final Shut Worth||1,76 $|
|Common goal value||40,00 $|
|Unfold / Common Goal||2 173%|