Marker Therapeutics Inc (MRKR)

[microcapbiotech]

Marker Therapeutics to Present at Canaccord Genuity’s Horizons in Oncology Conference April 7, 2025.
NOW THIS will get the stock price to over $10 (Yawn).

[learningcurve2020]

It is a joke. They have to get acquired by an entity with real cash otherwise it’s just another one of those research for researches sake companies funded by poor unsuspecting retail.

[learningcurve2020]

>>On March 27, 2025, the Company mutually agreed with Cell Ready to terminate the MSA. In connection therewith, the Company entered into a settlement and release agreement with Cell Ready pursuant to which the Company paid Cell Ready approximately $453,000 and the parties provided one another with mutual releases of all claims associated with any and all agreements between Marker and Cell Ready.

[microcapbiotech]

The Company is enrolling additional study participants in the Phase 1 APOLLO trial (sometime before 2036) and expects to report further data in the second half of 2025 (LOL).

[microcapbiotech]

https://ir.markertherapeutics.com/news-releases/news-release-details/marker-therapeutics-reports-year-end-2024-corporate-and

[learningcurve2020]

>>Additionally, BCM continues to supply us with products as we continue our clinical trials. Furthermore, in anticipation of the commencement of our larger pivotal trial for Lymphoma in 2026, as well as the eventual need for commercial scale production, we intend to evaluate and qualify additional potential third-party manufacturing partners to provide potential multiple sources of clinical and commercial supply. We currently are in discussions with a number of CDMO candidates and anticipate that we will select a partner organization and commence the qualification and technology transfer process later this year.

>> On March 16, 2018, we entered into an exclusive license agreement, or the BCM License Agreement, with BCM, under which we received a worldwide, exclusive license to BCM’s rights in and to certain intellectual property rights, including European patent EP 2470644 (estimated expiration date August 24, 2030), to develop and commercialize MAR-T cell product candidates.

>> Employees

As of December 31, 2024, we had 5 full-time employees: 1 clinical and 4 in administrative support. None of our employees is subject to a collective bargaining agreement. We consider our relationship with our employees to be good.

>> On December 19, 2024, we issued a press release providing an update on the progress and clinical observations from the Phase 1 APOLLO study, with a data cutoff date of September 10, 2024. Our Phase 1 APOLLO study is investigating MT-601, a MAR-T cell product, in patients with lymphoma who have relapsed after anti-CD19 chimeric antigen receptor (CAR) T cell therapy or where anti-CD19 CAR-T cells are not an option. A total of 10 patients have been treated in the study, for which clinical data is currently available for 9 patients from 5 clinical sites across the United States. Study participants showed early objective responses with and without lymphodepletion. However, immunomonitoring data confirmed that lymphodepletion enhanced the expansion and persistence of MAR-T cell clones in vivo.

>> Recent Developments

On December 19, 2024, the Company entered into a Securities Purchase Agreement (the “Purchase Agreement”), pursuant to which the Company issued and sold in a private Placement the following securities: (i) 1,783,805 shares of common stock, (ii) Series B Warrants, or Pre-Funded Warrants, to purchase an aggregate of 3,247,445 shares of common stock in lieu of shares of common stock and (iii) Series A Warrants, or Private Placement Warrants, to purchase an aggregate of 5,031,250 shares of common stock. The purchase price per share of common stock and accompanying Private Placement Warrant to purchase a share of common stock was $3.20, and the purchase price per Pre-Funded Warrant and accompanying Private Placement Warrant to purchase a share of common stock was $3.199. Total gross proceeds from the sale of securities in the Private Placement, before deducting commissions to the placement agent and estimated offering expenses, was approximately $16.1 million, which does not include any proceeds that may be received upon exercise of any warrants issued in the Private Placement. Both the Pre-Funded Warrants and the Private Placement Warrants are not exercisable until the Company obtains shareholder approval. On March 21, 2025, the Company obtained shareholder approval for the exercise of such warrants. The transaction closed on December 23, 2024.

On March 21, 2025, the Company held a Special Meeting of Stockholders (the “Special Meeting”) at which the stockholders approved, in accordance with Nasdaq Listing Rule 5635(d), of the issuance of the shares issuable upon exercise of (i) Series A Warrants to acquire 5,031,250 shares of Common Stock and (ii) Series B Warrants to acquire 3,247,445 shares of Common Stock.

>>Liquidity and Capital Resources

We have not generated any revenues from the sales or licensing of our product candidates since inception and only have limited revenue associated with grants to fund research. We have financed our operations primarily through public and private offerings of our stock and debt including warrants and the exercise thereof, grants, and in 2023 through the cash proceeds received from the Cell Ready transaction.

Based on our lack of recurring revenues, anticipated uses of cash and historical recurring cash losses from operating activities, and cash and cash equivalents as of December 31, 2024, we anticipate that we will be able to fund our operating expenses and capital expenditure requirements into the first quarter of 2026, assuming no additional grant funds are received. We currently plan to raise additional capital

[learningcurve2020]

I know it’s just a Pl but it seems like a game changer? Still just three patient follow ups?

>>Key findings from the APOLLO study include:

? Safety – Infusion of MT-601 was well tolerated in all study participants, with no observation of immune-effector cell associated neurotoxicity syndrome (ICANS) and one reported Grade 1 cytokine release syndrome (CRS). No dose limiting toxicities (DLTs) have been reported to date.
? Efficacy – In the first dose cohort, 7 out of 9 patients achieved objective responses (78%) at first response assessment, with 4 patients demonstrating complete response (CR; 44.4%) (Table 1).
? Time in Follow-Up – Long-term follow-up of 6 to 12 months is currently available for three patients (Table 2).

>>We reported interim data for an ongoing Phase 1/2 clinical trial (TACTOPS) of the MAR-T cell therapy targeting five TAAs for the treatment of pancreatic adenocarcinoma being conducted by BCM. In this trial, we have observed a clinical benefit with 4 of 13 patients (31%) showing objective responses in front-line unresectable or metastatic pancreatic cancer, which correlated with the post-infusion detection of tumor-reactive T cells in patient peripheral blood and within tumor biopsy samples in patients in the tumor-resection arm of the trial. To date, we have not observed any cytokine release syndrome or neurotoxicity in this trial.

In January 2022, the FDA granted orphan drug designation to MT-601 for the treatment of patients with pancreatic cancer. The FDA cleared our IND application for MT-601 in November 2022 to initiate the PANACEA study, a Phase 1 multicenter clinical trial in locally advanced, unresectable or metastatic pancreatic cancer to assess the safety and efficacy of MT-601 in combination with front-line chemotherapy. The PANACEA trial will include a dose escalation portion followed by a dose expansion portion. We recently announced that the Company has been awarded a $9.5 million grant from the Cancer Prevention & Research Institute of Texas (CPRIT) and a $2 million grant from the NIH Small Business Innovation Research (SBIR) program to support the clinical investigation of MT-601 in patients with metastatic pancreatic cancer. With the support of these grants, we will be able to advance MT-601 in pancreatic cancer without affecting our operations in the ongoing study of MT-601 in patients with lymphoma.

>> We were previously awarded grants from the FDA Orphan Products Grant program ($2 million), NIH Small Business Innovation Research (SBIR) program ($2 million) and the Cancer Prevention and Research Institute of Texas (CPRIT, $13 million), to support the Phase 2 clinical trial of MT-401. All funding agencies have agreed to continue their financial support and to shift funds to the MT-401-OTS program.

Off- the-Shelf MT-401 (MT-401-OTS) for the Treatment of AML and MDS:

Marker previously announced that it intends to focus on the advancement of the MT-401-OTS program in patients with Acute Myeloid Leukemia (AML) and Myelodysplastic Syndromes (MDS). MT-401-OTS has the potential to provide treatment to patients in as little as 72 hours. Marker believes that this fast turnaround time would be beneficial for treating patients with rapid cancer progression, such as patients with measurable residual disease (MRD) in the AML setting. In the OTS program, we intend to dose patients using “banked” products based on partially human leukocyte antigen (HLA) matching. The U.S. FDA has cleared our clinical protocol to investigate MT-401-OTS as a treatment in patients with AML. We already established a cellular inventory manufactured from healthy donors, with ongoing efforts to further expand the inventory. At full scale production, we estimate a single donor could provide treatment for approximately 40 patients, and the current stability program indicates that OTS MAR-T cell products are stable for more than a year in liquid nitrogen, which we expect will permit future on-demand availability for broad-scale implementation. We expect to dose the first patient in the second half of 2025, and, if our OTS program shows promising results in the clinic, we intend to expand the OTS platform to other hematological malignancies and solid tumors. With the grant support from the FDA Orphan Products Grant program, NIH Small Business Innovation Research (SBIR) program and the Cancer Prevention and Research Institute of Texas (CPRIT), the Company will be able to advance MT-401-OTS without affecting the investigation of its lead asset, MT-601, in patients with lymphoma.

[jobynimble]

10-K filing out: https://www.sec.gov/Archives/edgar/data/1094038/000141057825000549/mrkr-20241231x10k.htm

[learningcurve2020]

8-K out.

Item 5.07
Submission of Matters to a Vote of Security Holders.
On March 21, 2025, the Company held a Special Meeting of Stockholders (the "Special Meeting"). At the Special Meeting, the stockholders considered one proposal, which is described in more detail in the Company's definitive proxy statement filed with the Securities and Exchange Commission on February 4, 2025. Of the 10,709,005 shares outstanding as of the record date, 4,158,543 shares, or 38.83%, were present virtually or represented by proxy at the Special Meeting. Set forth below are the results of the matter submitted for a vote of stockholders at the Special Meeting.
Proposal 1: Approval, in accordance with Nasdaq Listing Rule 5635(d), of the issuance of the shares issuable upon exercise of (i) Series A Warrants to acquire 5,031,250 shares of Common Stock (the "Private Placement Warrants") and (ii) Series B Warrants to acquire 3,247,445 shares of Common Stock (the "Pre-Funded Warrants").
For Proposal 1, the votes were cast as follows:
Votes

[microcapbiotech]

Unfortunately I am expected an update on the first two patients that were dosed two years ago. Other than that, they will be "on track" based on their internal blah blah blah blah.
If we are lucky, they might add some yada, yada, yada to try to make it sound better than it actually is.
Time to click the green bull emoji now.

[ShadowHaven59]

Any guesses on earnings call? Does anybody expect any good surprises?

[bar1080]

"All the same people on these various Hub biotech boards."

Yep. All three of those people, LOL

[learningcurve2020]

All the same people on these various Hub biotech boards.

[learningcurve2020]

Looks like all the pumpers have abandoned ship. Nice work Phantom.

[learningcurve2020]

I sure have. What was the decided remedy for remaining on the NASDAQ? Please don’t say reverse split.

[BurrHeadBud]

So today, March 21st at 10AM EDT, was MRKR's special shareholder meeting. Decided for a change to not proxy my vote and instead attend online. Anyone else ever do that? Was my first time and found it laughable. The whole thing was less than 5 minutes, and was mostly a board member reading boiler plate language to satisfy some legal requirements, and naming other board members. That was followed by reading of statement for what was being voted on (basically agreeing, or not, on certain financial maneuvers to satisfy stock exchange I think). There was a link where you could vote, but sounded like they already had enough proxy votes to do what they wanted, and in less than a minute declared voting done. There was also a place to type questions, but nobody submitted after a minute or so wait. That was it, done, adios.

[learningcurve2020]

AlloVir’s disappearing act and then not using the cash left to acquire Marker was the imminent collapse signal, IMO.

[ShadowHaven59]

Wow, I hope they announce something new, next week on the earnings call otherwise we’re going under a dollar, again. Crazy I never thought I would say that.

[Monksdream]

MRKR under $2

[learningcurve2020]

It almost too high so much so that feels like retail bait for the final plunge. That’s the problem with all these analyst calls is there’s nobody keeping track and no accountability. But with so little shares outstanding $8 really isn’t that much in terms of market cap.

[microcapbiotech]

Are we up to that $8 price target yet?

[learningcurve2020]

When is the next trial update?

[learningcurve2020]

Looks like silent treatment on both boards. Hmm

[learningcurve2020]

Come on, Vera, let’s get it going!!!

[learningcurve2020]

As I recall the old management team bought on the open market a couple of years back. Went straight down hill from there but always wondered what went so wrong? Even still, it’d be good to see.

[microcapbiotech]

Canaccord Genuity Initiates Marker Therapeutics at Buy With $8 Price Target
07:22 AM EST, 03/05/2025 MT Newswires

[learningcurve2020]

Canaccord Genuity Initiates Marker at Buy with $8 Price Target. Anyone have their comments?

[microcapbiotech]

Is that 25,000 shares for each patient he enrolled?

[ShadowHaven59]

The Board of Directors have approved stock options of 50,000 shares for the CEO. how about buying some shares in the open market?

[learningcurve2020]

Vera has generated crickets. “Off the shelf” appears to be out the window.

[learningcurve2020]

No mystery. Research for researches sake on the backs of sucker public retail to benefit BP along with handsome executive salaries and perks. Always been that way in the biotech space but even worse these days.

[microcapbiotech]

I thought that is was supposed to be better, quicker, cheaper and safer than CAR-T with no cytokine release syndrome.

[Cincinnati Kid]

Was anybody able to access the presentation that is supposed to be taking place now?

[bar1080]

Well that's a partial answer to a question I've had for decades: Who buys obvious penny stock crap like this. "It’s still a mystery to me what MRKR actual goal was"

[KeithamdMIC]

Your right Phantom we all didn’t dig deep enough to figure out the actual science of this treatment. I dove in because of the so called patents that they acquired on the treatment which obviously didn’t mean anything. I take full responsibility for falling for a bio tech stock with false promises. It’s still a mystery to me what MRKR actual goal was. I thought it was an over the counter’therapy for different cancer related issues. I hadn’t looked at the share price in a long time so I willed myself to look. Not surprised in the least where it’s fallen to.

[microcapbiotech]

GREAT NEWS: Conference Call today. We may get an update on the two patients that they first dosed two years ago.
OH HAPPY DAY, wouldn't that be Special.

[learningcurve2020]

Maybe we’ll find they added a patient to the trial. 🙄…

Professor Vera, sell this company!!!

[ShadowHaven59]

Any chance we get new information at the conference today?

[microcapbiotech]

My only problem is that NEA ain't as old as me, so after my 25+ years in TPIV/MRKR they can afford to have more patience that me, mine has been running thin for these last few years.

[GoIrish1776]

NEA is a "true" venture firm with serious Silicon Valley roots. This is what they do. This company just happens to be public. They support their deals if there is an argument to do so.

I assume Baker Bros. is a hedge fund at heart, wants losers off their books if need be, etc. That said, I remember thinking, "They are being disciplined," when it happened. It was the smart move.

As a side note, it looks like the PI for OTS in AML is using lymphodepletion. If I read that correctly, that seems new (I think) and is consistent with a company mention that they did seem to see the benefit of that. Prior, they consistently said they didn't think it was necessary. (I'm running fast, so anyone should correct me if I have the facts wrong.)

[microcapbiotech]

Holy S--T, I was not aware of that. That kind of sucks.
I think for this post I am not going to click on the green bull emoji.

[Phantom Lord]

Baker brother bought in at the initial merger. Ended up selling their shares and their warrants expired worthless. Unlike NEA I would assume Baker brothers learned their lesson.

[microcapbiotech]

Yep, being that I never heard of Alyeska, Blue Owl, or Hudson Bay, it doesn't really inspire too much added confidence. Now if I see Baker Brothers come in with 5 or 10 million, I would take that as a good sign. I follow them just to see what their new investments are every quarter, they seem to do really well, I followed them into SMMT (SMMT worked well in China beating Keytruda, we will see about what happens in the US).

[Phantom Lord]

No real opinion. They made the same mistake all of us did putting money here too early. Their just able to pump more money into it in hopes of making something back. Don't care about the new investors much. They won't have a hand in if the company actually gets their shit together.

[microcapbiotech]

Phantom, Any opinion on NEA increasing their shares by 52% to 2.8 million dollars and Alyeska, Blue Owl, and Hudson Bay coming in with a combined 3 million (more than NEA currently has)?
Thanks

[GoIrish1776]

Looks like they are pivoting to include an HMA for AML...?
https://clinicaltrials.gov/study/NCT06552416
https://ir.markertherapeutics.com/news-releases/news-release-details/marker-therapeutics-reports-mt-401-non-clinical-data-aml-cells

I believe the Baylor data for lymphoma was also about 40% also. There is a research report "out there" articulating it, but I don't have time to dig it up now. If they went head to head with CAR-T and were equivalent, this would be a blockbuster because 40% is of people ineligible or who failed CAR-T. However, that test is very unlikely to happen.

[Phantom Lord]

I do not recall off the top of my head what the 401 results were but I don't believe the response rates were better than the 601 results. That being said we can't really compare the two because they are targeting two different types of cancers.

[Flyingj]

Phantom, do you recall the results from the the 401 Lymphoma trial. So far the 601 trial has a 44% complete response rate and a 77% objective response rate. I'm asking if the 601 formula appears to be any better than the 401 formula?

[ShadowHaven59]

Any guesses?? I’m going to take this as a positive.

[microcapbiotech]

Despite the price that has been going down. This just reported, a tiny bit interesting, NEA increases shares by 52%,
plus 3 new large buyers, which means ????
Owner Name Date Shares Held Change (Shares) Change (%) Value (In 1,000s)
Nea Management Company, Llc 12/31/2024 1,625,678 554,250 51.73% $2,796
Alyeska Investment Group, L.P. 12/31/2024 915,591 915,591 New $1,575
Blue Owl Capital Holdings Lp 12/31/2024 554,250 554,250 New $953
Hudson Bay Capital Management Lp 12/31/2024 331,670 331,670 New $570