CheckPoint Therapeutics Inc (CKPT)

[Monksdream]

CKPT under $2

[Monksdream]

CKPT 10Q due March 7

[chainma1l]

CKPT did a reverse split in the fairly recent past. I don't think that was in anticipation of anything specific other than selling additional shares in the future to raise money until they can generate some revenue. They were going to be selling shares whether or not they received the CRL. CRL just means they are going to be selling a LOT more shares than if they wouldn't have received it.

[timberwolf7]

So did investors get a 'gift'?
Just heard about CKPT after the CRL came out. First comment is, resolution of the CRL could take longer than folks expect, just went thru it with CRMD and they got 2 CRLS due to the manufacturers QA issues (4 frigging years for the fda to agree to the 'fixes' and all the while the manufacturers were ALLOWED to continue operations under the fda umbrella, someone explain that one)

Anyways, so looking into CKPT, like the low share count, don't like the low cash on hand cause can only read it to mean, thanks to the delay, they will likely need to conduct a cash raising operation (ATM or flat out secondary). CRMD had to do this and it really cut their target price down.

So, just thought I would check in, see what folks are saying, and quite frankly, a bit surprised given its a cancer related treatment, given how the market is pricing so many bios as if they are selling gold, that CKPT was where it was on the share price..

But going to be studying their trial analysis, how good they see it working. And really tired of the fda holding up drug approvals for drugs that CAN/WOULD help save lives vs delaying the approval especially if it worked. Now I wouldn't be as 'upset' at the fda if as in this case, they tell the manufacturer, since you are bad enough for us not to approve a potential life saving drug, your operations are totally suspended.
Otherwise, to me, the fda has its priorities screwed up.. when it allows operations to continue.. but puts a life saving drug into limbo land.. again, CRMD has something going for it, hell of a lot better than the current standard of care, but was delayed 4 frigging years over QA issues.

Good luck

[vein]

Stupid

[vein]

Wouldn’t mind seeing a partner for launch !!

[Monksdream]

Always a concern with start up biomeds

[vein]

Chart must look pretty good here . I wonder if another offering is coming ??

[Monksdream]

The positives continue

[vein]

Patent news is cool.

[Monksdream]

Been awhile so lets update the chart

[vein]

Let’s make a run into approval !!

[Monksdream]

CKPT under $2

[Monksdream]

CKPT new 52 week low

[timung]

CKPT https://www.tipranks.com/news/blurbs/b-riley-financial-sticks-to-their-buy-rating-for-checkpoint-therapeutics-ckpt

[timung]

CKPT https://www.tipranks.com/news/blurbs/lake-street-keeps-their-buy-rating-on-checkpoint-therapeutics-ckpt

[timung]

ckpt https://www.tipranks.com/news/blurbs/b-riley-financial-sticks-to-their-buy-rating-for-checkpoint-therapeutics-ckpt

[tw0122]

Biologics License Application currently under review by U.S. FDA; PDUFA goal date of January 3, 2024

WALTHAM, Mass., July 27, 2023 (GLOBE NEWSWIRE) -- Checkpoint Therapeutics, Inc. (“Checkpoint”) (Nasdaq: CKPT), a clinical-stage immunotherapy and targeted oncology company, today announced new, longer-term data for cosibelimab from its pivotal studies in locally advanced and metastatic cutaneous squamous cell carcinoma (“cSCC”). These results demonstrate a deepening of response over time, resulting in substantially higher complete response rates than previously reported. Furthermore, responses continue to remain durable over time with the median duration of response not yet reached in either group. Results determined by independent central review by treatment group were as follows:


Parametera Locally Advanced cSCC
(n=31) Metastatic cSCC
(n=78)
Data cutoff Mar 2022 Jan 2023 Nov 2021 Jan 2023
Objective response rate
(95% confidence interval) 55%
(36%, 73%) 55%
(36%, 73%) 47%
(36%, 59%) 50%
(39%, 62%)
Complete response rate 10 % 23 % 8 % 13 %
Partial response rate 45 % 32 % 39 % 37 %
Response ongoing 82 % 82 % 73 % 69 %
Median duration of response Not reached Not reached Not reached Not reached
a As assessed by independent central review.

“We are excited to see the substantial increases in the rate of patients experiencing a complete response of their cSCC tumors with further cosibelimab treatment in both our locally advanced and metastatic pivotal trials,” said James Oliviero, President and Chief Executive Officer of Checkpoint. “We believe cosibelimab’s strong efficacy and response durability are driven by its unique two-fold mechanism of action in which cosibelimab binds to PD-L1 with sustained high target tumor occupancy to reactivate the body’s T-cell anti-tumor response, with the addition of a functional Fc domain to activate the body’s natural killer immune cells to induce antibody-dependent cell-mediated cytotoxicity of tumor cells, resulting in a powerful one-two punch to eradicate tumors. We expect this dual mechanism of action to benefit not just immunocompetent patients, but also the large number of difficult-to-treat patients with immunosuppressive conditions or taking immunosuppressive medications who continue to suffer poor outcomes with currently available treatments.”

Updated safety data across 247 patients enrolled and treated with cosibelimab in all cohorts of the ongoing study remain consistent with those previously reported, with only 2% of patients experiencing a severe immune-related adverse event (“irAE”) and less than 1% of patients discontinuing treatment due to an irAE of any severity, both substantially lower than the rates observed with currently approved immunotherapies.

Mr. Oliviero continued, “Unlike PD-1 inhibitors, cosibelimab does not interrupt the body’s PD-1/PD-L2 pathway, which we believe results in cosibelimab’s low rates of autoimmunity. We believe cosibelimab’s favorable safety profile should position the product as the preferred immunotherapy of oncologists for the large number of high-risk cSCC patients, such as those with solid organ transplants or autoimmune disease, upon its potential launch early next year. If our Biologics License Application (“BLA”) is approved in the coming months, based on its unique mechanism of action and compelling efficacy and safety profile, we believe cosibelimab, as a differentiated and possibly best-in-class treatment, has the potential to become the market leading immunotherapy for patients with cSCC, which we estimate to be a $1.6 billion annual U.S. market opportunity.”

In January 2023, Checkpoint submitted a BLA to the U.S. Food and Drug Administration (“FDA”) seeking approval of cosibelimab as a treatment for patients with metastatic cSCC or locally advanced cSCC who are not candidates for curative surgery or radiation. The application is filed and under review with a Prescription Drug User Fee Act (“PDUFA”) goal date of January 3, 2024.

Checkpoint plans to present these updated results at an upcoming medical conference.

[vein]

We can only hope !!!

[chainma1l]

Does that $10 million get them to PDUFA? Seems like chump change. I'm guessing they are hoping they can raise some more money once the stock starts to push up as PDUFA gets closer.

[glenn1919]

CKPT............................https://stockcharts.com/h-sc/ui?s=CKPT&p=W&b=5&g=0&id=p86431144783

[glenn1919]

CKPT.......................https://stockcharts.com/h-sc/ui?s=CKPT&p=W&b=5&g=0&id=p86431144783

[glenn1919]

CKPT.....................https://stockcharts.com/h-sc/ui?s=CKPT&p=W&b=5&g=0&id=p86431144783

[vein]

This stock sure is volatile!!

[vein]

Yeah , especially with the rise in stock price

[Monroe1]

Looks to me like they will have to do another stock offering. I think they have enough cash to last until June.

[vein]

Market still only 80 million

[vein]

Do we think another stock offering here soon ?? I’m sure they could use the cash

[Monroe1]

a recent holding split... medi wound, and now up 800%. sold before the split and did not buy back in. made some bucks but really missed out on the upswing.

[Monroe1]

Good point to remember. Big moves are quite possible. And anything is possible especially for the real big time insiders. Unfair to have such competition I say.

https://www.theblaze.com/news/moderna-neglected-to-share-damning-data-about-its-new-booster-shot

[vein]

When you think about it, our market cap is still tiny !!!

[vein]

Yeah , just hope we hold on to some of the gains !!!

[Monroe1]

This happened to me on another ticker. Last month it RS'd and now up 45%.
Just goes to show a RS does not always spell doom. After all, it leads to new investors and sometimes to a higher exchange or platform like QB or Nasdaq/NYSE/Amex and later to increasing the AS and raising money for expansion.

[vein]

Should have scooped up after the split ??

[Monroe1]

very few left. looking to re enter.

[vein]

Thanks for the input Monroe ! You still own shares ???

[Monroe1]

Looks to me like a Director has converted half or so of their preferred into common stock which often is done before a run up on the pps of common. Look for events to be forth coming. IMO

[vein]

Hey Monroe , what’s the form 4 mean that was presented after hours from fortress biotech ??

[Monroe1]

Checkpoint Therapeutics Submits Biologics License Application for Skin Cancer Therapy

MT NEWSWIRES

11:27 AM ET 01/04/2023

11:27 AM EST, 01/04/2023 (MT Newswires) -- Checkpoint Therapeutics (CKPT) said Wednesday it has submitted a biologics license application to the US Food and Drug Administration for the approval of cosibelimab to treat patients with metastatic cutaneous squamous cell carcinoma or locally advanced cSCC who are not candidates for curative surgery or radiation.

The application is backed by positive efficacy and safety data from its ongoing trial of cosibelimab, the company said.

Shares of Checkpoint Therapeutics (CKPT) rose more than 6% in recent trading activity.

[vein]

I’m stating to wish I added after the reverse split !!

[vein]

There is the BLA

[Monroe1]

wow, just got back home, nice gain!

[chainma1l]

Sure seems that way. I should have bought at the low.

[vein]

BLA on the way ??

[vein]

2023

[dtgsanjose]

I don't expect to be around in 3023, but I have some hope for gains in the next few months, though probably not enough to make up for my losses on shares I bought over the past two or three years. I added a very small number of shares today as it seems to be recovering from the crater following the reverse split announcement

[vein]

Anyone think we can look forward to recovery here in 3023?

[Monroe1]

Maybe that's why they lowered the AS so substantially? Maybe that's why they just need the $7.5 million to get them by a little longer?

That is a good point. You may be right about this.

[vein]

Might be something to get excited about

[vein]

It seems the BLA is coming soon !!