Total revenue for the fourth quarter of 2023 was $84.2 million, compared to $59.6 million in the fourth quarter of 2022. Net loss was $0.5 million, compared to a net loss of $9.6 million in the fourth quarter of 2022. Net loss per share was $0.01, compared to a net loss per share of $0.20 in the fourth quarter of 2022.
https://ir.aerogel.com/news/news-details/2024/Aspen-Aerogels-Inc.-Reports-Fourth-Quarter-and-Fiscal-Year-2023-Financial-Results-and-Recent-Business-Highlights/default.aspx

Just saw a tv report showing Supernal (Hyundai?) evtol, looks incredibly like Archer's.
The word "ripoff" comes to mind. Wonder if Archer has anything to say.
link to story and photo

On Tuesday, Cathie Wood-led Ark Invest continued to purchase shares of Archer Aviation Inc , a flying taxi company. This move comes a day after Ark Invest’s significant purchase of Archer shares.

The Archer Aviation Trade: Ark Invest acquired a substantial number of shares of Archer Aviation for the second consecutive day. The trade, made through the ARK Innovation, was valued at $16 million, based on Archer’s closing price of $5.94.

The firm’s interest in Archer has been evident, especially after the eVTOL aircraft maker recently secured a $215 million equity investment from industry giants like Boeing Co, Stellantis N.V., and United Airlines. This investment boosted Archer’s total funding to over $1.1 billion.

Furthermore, Archer’s Midnight eVTOL aircraft received FAA approval, and the company announced a collaboration with Boeing and Wisk Aero for autonomous flight technology. Adam Goldstein, CEO of Archer, expressed optimism about the U.S. government’s commitment to eVTOL aircraft and the collaboration with industry leaders.......
https://markets.businessinsider.com/news/etf/cathie-wood-s-ark-invest-buys-16m-worth-of-shares-of-flying-taxi-company-archer-aviation-%E2%80%94-sells-shopify-stock-worth-millions-1032561415

Oppenheimer analyst Leland Gershell maintains Veru, Inc. at Outperform with a price target of $36.00, following a recent FDA AdComm vote.
(from a post on yhoo)
Veru (VERU): "See EUA More Likely Than Not " - Oppenheimer Reiterates Stock at Outperform, $36 PT, November 10, 2022 6:30 AM EST
The analyst comments: "At face value, yesterday's advisory committee vote of 5 yes, 8 no to the single voting question of whether sabizabulin's benefits outweigh its risks in those hospitalized with COVID-19 at high risk of ARDS may be taken by some as fait accompli that the FDA will deny VERU's EUA request. Irrespective of their individual votes, all the panel members were favorable on the drug's potential utility and expressed appreciation for the considerably limited amount of efficacy, safety, and mechanistic understanding on sabizabulin, as well as the potential for various aspects of the Phase 3 trial to have biased its outcome. We believe the key distinction between those who voted "yes" vs. "no" was the standard against which this unique case was measured—a standard that may have been unreasonably stringent in the minds of the "no" voters, as the Phase 3 was conducted during a critical/chaotic period of the pandemic in which more ideal trial conditions simply may not have existed.

We believe the most reasonable course of regulatory action will be that which the briefing documents appeared to lay out, that is, for the FDA to authorize sabizabulin for emergency use in the Phase 3 population (WHO 5 and 6, or WHO 4 with comorbidities) and, as a condition of such, stipulate that VERU conduct another randomized double-blind trial in the same population in which patients are fully matched with respect to baseline characteristics and evaluates sabizabulin for superiority to placebo on top of standard of care."

Either someone has learned to play this stock, repeating
this exercise monthly, or more hopefully someone wants
to buy a lot of shares w/o driving the price up too much,
so buys some and waits for the price to drop before repeating.

wtf?

5.6 million shares AH so far (6:40pm), vs. half million during mkt hrs.
AH high so far .90.

Marker Therapeutics Announces FDA Clearance of IND for MT-601, the six-antigen targeted T Cell Therapy for the treatment of relapsed/refractory Non-Hodgkin Lymphoma
https://ir.markertherapeutics.com/news-releases/news-release-details/marker-therapeutics-announces-fda-clearance-ind-mt-601-six

test test

Interesting rise on volume-

https://investorshub.advfn.com/uimage/uploads/2022/3/22/[jmdqmarker1.JPG

Issuer failed to meet NASDAQ continued listing requirements
Message from broker. I guess this had to happen.

I'm sure we all agree that after hours trading means nothing.

Marker Therapeutics Announces Clinical Program Updates and Pipeline Expansion
February 16, 2022 at 4:30 PM EST

Results from safety lead-in stage of Marker’s Phase 2 AML trial demonstrate that MT-401 was well-tolerated, eliminated measurable residual disease (MRD) in one MRD+ patient and induced epitope spreading

New T cell manufacturing process for MT-401 and other product candidates designed to improve potency, increase antigen specificity and diversity and significantly reduce manufacturing time

Company announces clinical updates, including plans to file additional INDs by year end, with clinical trials in solid tumors and blood cancers to be initiated in 2023

Company to host conference call and webcast at 5:00 p.m. EST today

HOUSTON, Feb. 16, 2022 (GLOBE NEWSWIRE) -- Marker Therapeutics, Inc. (Nasdaq:MRKR), a clinical-stage immuno-oncology company specializing in the development of next-generation T cell-based immunotherapies for the treatment of hematological malignancies and solid tumor indications, today announced an update on the Company’s clinical programs, manufacturing processes and pipeline.

“We are excited to announce an improved T cell manufacturing process, expansion of our pipeline into solid tumor and off-the-shelf cell therapies, and encouraging results from the six-patient safety lead-in stage of our Phase 2 AML trial, where one MRD positive patient converted to MRD negative following treatment with MT-401, Marker’s lead MultiTAA-specific T cell product candidate,” said Peter L. Hoang, Marker’s President and Chief Executive Officer. “Our new T cell manufacturing process, which will be implemented in AML and additional planned trials, is designed to produce a much more potent product with increased antigen specificity and diversity and further reduces manufacturing time to just nine days.”

Mr. Hoang continued: “Further, we are pleased to announce a planned expansion of our pipeline into pancreatic cancer, our first Company-sponsored trial evaluating MultiTAA cell therapy for the treatment of solid tumors, and a Company-sponsored Phase 1 trial in lymphoma. We are also excited to expand our AML trial with MT-401-OTS, a scalable, off-the-shelf product candidate with the potential to match patients to treatment in under three days. Looking ahead, we plan to develop additional off-the-shelf product candidates in other hematological malignancies and solid tumors, with the goal of significantly improving access to promising cell therapies.”

Safety Lead-in Results from Phase 2 AML Trial

The results of the safety lead-in stage of the Marker Phase 2 AML trial support the potential for MT-401 as a treatment option for patients with AML in the post-transplant setting. The purpose of the safety lead-in was to test the safety for patients using a new reagent in the manufacturing process. Three patients were treated with MT-401 using the legacy reagent and three additional patients were treated with MT 401 using the new reagent. The safety lead-in enrolled five patients with active disease: one MRD positive patient and five frank relapse patients.

The initial results from the safety lead-in are as follows:

No dose limiting toxicities, cytokine release syndrome or neurotoxicity were observed. The results were consistent with the safety data observed in more than 150 patients treated in the Phase 1/2 studies at the Baylor College of Medicine.
1 MRD+ patient became MRD- after infusion with MT-401
No objective responses from the frank relapse patients
Immuno-monitoring data indicates the evidence of epitope spreading after infusion of MT-401 in the patient who converted from MRD+ to MRD-

The safety lead-in satisfied safety requirements with the FDA and the main Phase 2 stage of the AML trial began enrolling in July 2021.

MultiTAA-Specific T Cell Therapy Manufacturing

The Company developed and is implementing a new nine-day MultiTAA-specific T cell manufacturing process for its current Company-sponsored Phase 2 AML trial as well as future clinical trials using a patient-specific manufacturing approach. The new manufacturing process marks additional manufacturing improvements compared to the processes used in the Baylor College of Medicine Phase 1/2 trials (36-day manufacturing time) and the current AML trial (20-day manufacturing time). The new nine-day manufacturing process enables increased antigen specificity and diversity, which has exhibited a strong linear correlation to anti-tumor activity in vitro. The new process produces a patient product that is four times more potent, with the potential to greatly improve tumor killing.

Pipeline Expansion

The Company plans to initiate additional Marker-sponsored clinical trials across other indications. The Company has initiated activities to support the advancement of the pipeline but beginning any additional clinical trial is subject to the receipt of additional funding:

Patient-specific product candidates
MT-601, a six-antigen product, for the treatment of pancreatic cancer and lymphoma
The Company intends to file Investigational New Drug applications (INDs) for MT-601 in pancreatic cancer and lymphoma in 2022 and expects to initiate these trials in 2023
Off-the-shelf (OTS) product candidates
Patients will be dosed using “banked” products based on human leukocyte antigen (HLA) matching
The OTS platform is designed to eliminate manufacturing wait time and patient product can be shipped to patients immediately
High scalability where one donor has the potential to provide more than 100 patient products
An OTS program in AML is already approved under the Company’s current Phase 2 AML IND. The Company is currently in the process of developing its patient cell bank inventory and expects to dose the first patient in 2023.
The Company expects to expand OTS clinical trials in other hematological malignancies and solid tumors
Preclinical / development activities
Analyzing potential of a 12-antigen product
Assessing potential of combination therapies for MT-401 and MT-601

Marker Therapeutics to Host Clinical Program Update Conference Call and Webcast on Wednesday, February 16, 2022


February 8, 2022 at 4:05 PM EST

HOUSTON, Feb. 08, 2022 (GLOBE NEWSWIRE) -- Marker Therapeutics, Inc. (Nasdaq:MRKR), a clinical-stage immuno-oncology company specializing in the development of next-generation T cell-based immunotherapies for the treatment of hematological malignancies and solid tumor indications, today announced that it will host a conference call and webcast on Wednesday, February 16, 2022 at 5:00 p.m. EST to provide an update on the Company’s clinical programs, manufacturing processes and pipeline.

The webcast will be accessible in the Investors section of the Company's website at www.markertherapeutics.com. Individuals can participate in the conference call by dialing 877-869-3847 (domestic) or 201-689-8261 (international) and referring to the "Marker Therapeutics Clinical Program Update Call."

The archived webcast will be available for replay on the Marker website following the event.

Up so far on another Biotech down day
Seems like a good omen.

2.9 million shares traded after hours +13%

FDA grants OrphanDrug designation_MT-601 Stock+.16 AH
Marker Therapeutics Reports Received FDA Orphan Drug Designation For Multi-Antigen Targeted T Cell Therapy For Pancreatic Cancer
4:51 pm ET January 19, 2022 (Benzinga) Print

Marker Therapeutics, Inc. (NASDAQ:MRKR), a clinical-stage immuno-oncology company specializing in the development of next-generation T cell-based immunotherapies for the treatment of hematological malignancies and solid tumor indications, today announced that the United States Food and Drug Administration (FDA) Office of Orphan Products Development has granted Orphan Drug designation to MT-601, a multi-tumor-associated antigen (MultiTAA)-specific T cell product optimized for the treatment of patients with pancreatic cancer.

“The FDA’s orphan drug designation underscores MT-601’s potential as a treatment for pancreatic cancer, a cancer typically diagnosed at an incurable advanced stage with a total overall 5-year survival rate of 10%,” said Peter L. Hoang, President & CEO of Marker Therapeutics. “Our novel therapy has shown encouraging results in an ongoing Phase 1 trial sponsored by Marker’s partners at the Baylor College of Medicine. In results reported at the 2020 American Society of Clinical Oncology (ASCO) Virtual Annual Meeting, our therapy has demonstrated the potential to safely produce durable responses in combination with chemotherapy as a first-line treatment option for patients with advanced or metastatic pancreatic adenocarcinoma. The results also revealed that epitope spreading was consistent in responders to Multi-TAA-specific T cells. Following MT-401 for the treatment of post-transplant acute myeloid leukemia (AML), MT-601 is Marker’s second novel MultiTAA-specific T cell product to receive orphan drug designation and the first in a solid tumor indication, underscoring the potential of Marker’s multi-antigen targeting T cell therapy approach in both solid tumors and blood cancers.”

Marker developed MT-601, a new product targeting six tumor-associated antigens (PRAME, NY-ESO-1, Survivin, MAGE-A4, SSX2, WT1) highly expressed in pancreatic cancer. The Company intends to initiate a Phase 1 multicenter study of MT-601 administered in combination with front-line chemotherapy to patients with locally advanced unresectable or metastatic pancreatic cancer. Marker designed the study to include an initial antigen escalation period followed by a dose escalation period and will enroll 20 – 25 patients for the study.

The Company plans to file an Investigational New Drug Application (IND) for MT-601 for the treatment of pancreatic cancer in 2022.

Orphan designation is granted by the FDA Office of Orphan Products Development to advance the evaluation and development of safe and effective therapies for the treatment of rare diseases or conditions affecting fewer than 200,000 people in the U.S. Under the Orphan Drug Act, the FDA may provide grant funding toward clinical trial costs, tax credits, FDA user-fee benefits, and seven years of market exclusivity in the United States following marketing approval by the FDA. The granting of an orphan designation request does not alter the standard regulatory requirements and process for obtaining marketing approval. For more information about orphan designation, please visit the FDA website at www.fda.gov.

Softbank Group funds are largest holders; $800million in each of 2
of their funds- Softbank Vision and Softbank Investment Advisors UK.
Softbank is a Japanese banking group. Interesting that they are
such large holders. Also Bill and Melinda Gates, and many other impressive holders on the list.
https://whalewisdom.com/stock/vir

1 MillionShrs in 1/2hour, spiking briefly +.16
Interesting move there. From 2:45 to 3:15.
Would be nice to know who that was.

Ph1_Study Results to_be presented at ASHA_Meeting Dec1

Marker Therapeutics Announces that Data from Investigator-Sponsored Phase 1 Study With its MultiTAA-Specific T Cells to be Presented at the 2021 American Society of Hematology Annual Meeting
November 18, 2021 at 4:05 PM EST
Researchers from Baylor College of Medicine to review results from STELLA study in oral presentation
Phase 1 Study With its MultiTAA-Specific T Cells to be Presented at the 2021 American Society of Hematology Annual Meeting


HOUSTON, Nov. 18, 2021 /PRNewswire/ -- Marker Therapeutics, Inc. (NASDAQ: MRKR), a clinical-stage immuno-oncology company specializing in the development of next-generation T cell-based immunotherapies for the treatment of hematological malignancies and solid tumor indications, today announced that data from a Phase 1 study investigating its MultiTAA-specific T cells were selected for oral presentation at the 2021 American Society of Hematology (ASH) Annual Meeting. The results will be reviewed by investigators at the Baylor College of Medicine, Marker's research partner. ASH will take place from December 11-14, 2021, in Atlanta and in a virtual format.

Oral Presentation Details

Presentation Title: Donor-Derived Adoptive T-Cell Therapy Targeting Multiple Tumor Associated Antigens to Prevent Post-Transplant Relapse in Patients with ALL (Abstract #471)
Session Title: 704. Cellular Immunotherapies: Cellular Therapies for ALL
Session Date/Time: Sunday, December 12, 2021, 12:30 p.m. ET
Presenting Author: Dr. Swati Naik, MBBS, Center for Cell and Gene Therapy, Baylor College of Medicine
Location: Georgia World Congress Center, B401-B402 and virtual

Presentation starting now. 2:40 PM Eastern
https://journey.ct.events/view/584e81b0-b28e-4347-960e-b163c4e3c3a1

Amazing. Could it be that this $13m was from a group that is so highly respected that it caused such action? Maybe the opinion behind this choice counts a lot more than some commercial analyst's opinion. Still there was a lot of profit taking, so traders had a lot to do with it all too. All in all though I like it.

If you couldn't imagine it before, now you have seen a little but powerful indication of what good news will do the share price. One day's price rise may not have made anyone a lot of money, but there was greater value in the preview of the SP response to good news. How much clearer could it be? If $13m caused such an after hours riot of buying, wtf do you think will happen with news of a major trial success, or some other? These kind of biotech stocks can remain incredibly undervalued until they prove themselves in Ph3, to the frustration of shareholders. Patience.

Prepare to be impressed. Baxter Trash. Generated by real humans? I'm not sure why such sites even exist.


The Baxter Report

From May 28, 2017, the Baxter Report received a certificate of state registration of an information agency as a subject of information activity, and thus is a full-fledged media. The main slogan that confesses to the publication is to reliably, reasonably and promptly cover most of the life span of the state and the United States in general. Due to this, publications are actively distributed in social networks, causing a resonance in society. Interviews and analytics, articles and contests, multimedia and interactive communication – all of this allows Baxter Report users to stay in the center of the most important – life that surprises us and makes us think about the future.

845,637 after hours shares traded as of 16:32
That's impressive.

Machine like, isn't it?

WEBCAST AT 5PM EASTERN TODAY 5/12
https://ir.markertherapeutics.com/events/event-details/marker-therapeutics-first-quarter-2021-financial-and-operating-results

Don't forget that not only Marker but many Bio companies have been slowed in their work by the incredible focus of attention and resources on Covid. This was Peter on May 11-

“While we are eager to initiate our planned Phase 2 trial with our novel MultiTAA-specific T cell therapy in patients with acute myeloid leukemia (AML), we anticipate that the initiation of our trial will be delayed by the impacts the COVID-19 pandemic has had on our clinical trial partners and throughout our supply chain. As a result of the uncertainty, we believe it is prudent to withdraw our prior guidance on the timing of this trial until the outlook clarifies,” said Peter L. Hoang, President & CEO of Marker Therapeutics.

Nothing really in the news item- am I missing something? Wait till
29th.



Presentation Details

Title: “A phase I trial targeting advanced or metastatic pancreatic cancer using a combination of standard chemotherapy and adoptively transferred nonengineered, multiantigen specific T cells in the first-line setting (TACTOPS)”
Authors: Smaglo BG, et al.
Session Type: Poster Session
Session Title: Gastrointestinal Cancer—Gastroesophageal, Pancreatic, and Hepatobiliary
Abstract: 4622
Poster: 230

The presentation will be available on demand to ASCO registrants beginning May 29, 2020 at 8:00 a.m. ET. The poster will be available in the Investors section of the Company’s website at markertherapeutics.com.

5PM Eastern, I'm pretty sure.

Are you claiming that CR was a "primary outcome"? Below from Clinical Trial website-
Primary Outcome Measures :

1) Number of patients with treatment related serious adverse events [ Time Frame: 7 months ]
To determine the safety of up to 6 intravenous infusions of multiTAA-specific T cells in pancreatic cancer patients with metastatic, locally advanced unresectable, or resectable disease.

2) Number of patients who received 6 infusions of multiTAA-specific T cells [ Time Frame: 6 months ]
To determine the feasibility of completing a total of 6 intravenous infusions of multiTAA-specific T cells to pancreatic cancer patients with metastatic, locally advanced unresectable, or resectable disease


Secondary Outcome Measures :

1) Progression Free Survival using the Kaplan-Meier method [ Time Frame: 5 years ]
To evaluate the progression-free of patients after multiTAA-specific T cell infusions

2) Overall Survival using the Kaplan-Meier method [ Time Frame: 5 years ]
To evaluate the overall survival of patients after multiTAA-specific T cell infusions
---------------------------------------------------------
There has been a lot of hope expressed for another CR, but that's just what some people would like to see.

New investors may be informed by this error.
How many times have you run across an interesting new stock by chance?
Happens all the time. So a bunch of covid speculators might not bring in a lot of long term hold types, but any number of new investors/speculators would add liquidity and maybe some word of mouth for a stock that can use it.

Far Freaking Out, if I may say.

recent changes

.........................................................holdings+..mkt val...change.......source date

JACOBS LEVY EQUITY MAN, INC 148,280 $427,000 148,280 13F 2019-12-31
MORGAN STANLEY........................187,315 $540,000 37,933 13F 2019-12-31
GOLDMAN SACHS GROUP INC......43,253 $124,000 28,727 13F 2019-12-31
UBS GROUP AG...............................40,538 $117,000 17,196 13F 2019-12-31
DEUTSCHE BANK AG......................38,439 $109,000 30,451 13F 2019-12-31
OXFORD ASSET MAN llp.................29,547$85,000 29,547 13F 2019-12-31
VIGILARE WEALTH MAN ................117,800$306,000 117,800 13F 2019-12-31
ARROWSTREET CAP, LTD PART.....121,850$351,000 52,200 13F 2019-12-31
RENAISSANCE TECHN LLC............119,100$343,000 119,100 13F 2019-12-31
ARROWSTREET CAP, LTD PART.....121,850$351,000 52,200 13F 2019-12-31
BlackRock Inc.................................1,927,447 $5,55mil 92,101 13F 2019-12-31
GSA CAPITAL PARTNERS LLP......167,269 $482,000 167,269 13F 2019-12-31

Of course when you say "Not sure if we can get more than the two in Complete Remission", you don't mean in the whole 45 patients, but in the 12 earliest patients, the ones with data given so far.
With 1 or 2 in that group, there is hope for 2 or more in the whole 45. Maybe even several, if "lucky".

Novavax makes vaccines for prevention. NNVC makes drugs, to treat after infection.

When I post stuff like that I found that I must put .... instead of spaces between groups of numbers, otherwise they will collapse. Not worth the trouble when there are a lot of entries. Or a person can do an image, which takes another kind of effort.

Redplate suggested that there may be a good side to the delay. No doubt though it is testing our patience a little.

"Peter any hold is for a real reason, and no they are not trivial. In this case it appears that the hold relates to third party suppliers of reagents used in the culture of T cells. The trial is designed to be a potentially pivotal trial if results warrant as a repeat of early results. Thus fully compliant processing is essential so that these results can be used for a potential submission. A delay yes. Resolution suggests that FDA will consider this 20 center study as potentially useful for an approval.
Compliance in cell therapy settings has been an evolving set of regulations at FDA with newer guidance documents describing critical reagents and processing needs for ‘single patient’ production. A struggle within FDA between the blood /processing regulations and the center for drug development. It’s been hard for companies to comply with somewhat conflicting regulations/guidance.
This is now evolving quickly in the days of CAR T cell therapies in particular with respect to reagents used that ultimately do not even end up in the ‘product T cells’. I will suggest that recombinant T cell products have made it harder for this less invasive/cell altering approach. As a CMC guy these issues are pretty straight forward after some vendor qualification work this will go forward with a greatly reduced risk that the trials results could be compromised.
Just my humble opinion of course"

Not quite sure what that means.

Where do you say you got this info?
'Marker continues to go back-and-forth with the FDA regarding questions about some “reagents” used in the production of Marker’s multiTAA therapies. Marker has already secured an alternate source...'