Cyclacel Pharmaceuticals Inc (CYCC) News

Low $2s added $2.16- $2.22…BERKELEY HEIGHTS, N.J., June 03, 2024 (GLOBE NEWSWIRE) -- Cyclacel Pharmaceuticals, Inc. (NASDAQ: CYCC, NASDAQ: CYCCP; "Cyclacel" or the "Company"), a biopharmaceutical company developing innovative medicines based on cancer cell biology, today announced that new clinical, pharmacokinetic (PK) and pharmacodynamic (PD) data from the CYC065-101 study of fadraciclib as oral monotherapy was presented at a poster at the American Society of Clinical Oncology (ASCO) Annual Meeting from May 31-June 4, 2024 in Chicago, IL. See link to poster here.

“We are excited to report data with fadraciclib monotherapy from the entire Phase 1 population at ASCO. Clinical benefit was observed in heavily pretreated patients with several tumor types, including endometrial, lung, ovarian, pancreatic cancer, and T-cell lymphoma,” said Spiro Rombotis, President and Chief Executive officer. “Retrospective analysis suggests that this activity may be associated in part with alterations in certain tumor suppressor genes forming a hypothesis which we are testing in the ongoing Phase 2 part of the study. We look forward to reporting initial proof of concept data in the second half of 2024.”

“We are encouraged about the early safety and efficacy results of our novel therapeutic candidate fadraciclib. We are continuing fadraciclib’s development in the proof of concept part of the 065-101 study, initially in patients prospectively selected for CDKN2A/CDKN2B alterations, followed by patients with T-cell lymphoma,” added Brian Schwartz, M.D., interim Chief Medical Officer.

New clinical, PK and PD data were presented at ASCO from the fully enrolled, Phase 1, dose escalation part of the CYC065-101 study of fadraciclib as monotherapy (n=47). The patients were heavily pretreated, having received a median of four prior lines of therapy.

Fadraciclib was generally well tolerated with good compliance between dose levels 1 and 5. The most common treatment related adverse events reported were nausea (66.0%), vomiting (46.8%), diarrhea (31.9%) fatigue (25.5%), and hyperglycemia (21.3%). A total of 25 drug-related SAEs were reported in 8 patients, with most common being hyperglycemia (n=4), platelet count decrease (n=3), and accidental overdose (n=3).

There were no drug-related SAEs at dose level 5 (100 mg bid, 5 days a week, for 4/4 weeks) which was selected for the Phase 2 proof of concept part of the 065-101 study. PKs were dose-proportional and exceeded the preclinical efficacy targets for both CDK2 and CDK9. PDs evaluated in peripheral blood showed suppression of CDKN2A/B by four hours post treatment in most patients who received 100 mg bid or higher.

A total of 34 patients had measurable target lesions at baseline. Two partial responses were reported in patients with T-cell lymphoma, one of whom had CDKN2A loss. A squamous non-small cell lung (NSCLC) cancer patient with CDKN2A and CDKN2B loss achieved 22% reduction in tumor burden at 4 weeks per RECIST 1.1 criteria. In addition, clinical benefit was reported in two patients with endometrial cancer, and one each with ovarian and pancreatic cancers.

The proof of concept part of the study is now enrolling patients with CDKN2A/B loss or T-cell lymphoma.

Details of the presentations are as follows:

Title: A phase 1 study evaluating the safety, pharmacokinetics, and efficacy of fadraciclib, an oral CDK2/9 inhibitor, in patients with advanced solid tumors and lymphoma

Abstract No.
for Publication: 3125

Session Title:
Poster Session – Developmental Therapeutics—Molecularly Targeted Agents and Tumor Biology

Date and Time:
June 1, 2024, 9:00 AM - 12:00 PM CDT

About Cyclin-Dependent Kinases and Fadraciclib
Cyclin-dependent kinases (CDKs) are critical for cell cycle control and transcriptional regulation. Dysregulated CDKs have been linked to the cancer hallmarks of uncontrolled proliferation and increased cancer cell survival. Fadraciclib is a highly selective, potent, orally and intravenously available, next generation inhibitor of CDK2 and CDK9. By inhibiting CDK2 and CDK9 fadraciclib causes apoptotic death through anaphase catastrophe of cancer cells at sub-micromolar concentrations.

To date single agent activity, including CR, PR and SD, has been observed in patients with advanced endometrial, squamous non-small cell lung, ovarian and pancreatic cancers and also T-cell lymphoma. In an earlier Phase 1 study of intravenous (IV) fadraciclib, a heavily pretreated endometrial cancer patient with CDKN2A, CDKN2B and MTAP loss achieved confirmed CR and remained on treatment for approximately three years.

065-101 Study of Oral Fadraciclib

Oral fadraciclib is being tested in a Phase 1/2 trial for the treatment of advanced solid tumors and lymphoma (065-101; NCT#04983810). A total of 47 patients have been treated as monotherapy in this ongoing study. The study is enrolling unselected, all comer patients with advanced solid tumors and lymphoma.

The proof of concept part of the 065-101 study is designed to further evaluate fadra safety and efficacy in up to 8 cohorts defined by histology and/or NGS. The study is currently enrolling the biomarker cohort for patients prospectively selected for CDKN2A/CDKN2B alterations and the T-cell lymphoma cohort. The study is powered to demonstrate response in the molecular subtype suggested by the Phase 1 data and others that may be sensitive.

CDKN2A, CDKN2B deletions

CDKN2A gene deletions occur in over 10% of several solid tumors, including glioma, head and neck, pancreatic, esophageal, lung (incl. squamous), bladder, hepatobiliary, breast, melanoma, sarcoma, and others. CDKN2A deletions have been reported in 46% of patients with PTCL-NOS, a subtype of lymphoma. CDKN2B deletions occur in over 10% of several solid tumors, including bladder, glioma, lung (incl. squamous), head and neck, pancreatic, melanoma, esophageal, sarcoma, hepatobiliary, breast, ovarian and others.

About Cyclacel Pharmaceuticals, Inc.

Cyclacel is a clinical-stage, biopharmaceutical company developing innovative cancer medicines based on cell cycle, transcriptional regulation and mitosis biology. The transcriptional regulation program is evaluating fadraciclib, a CDK2/9 inhibitor, and the anti-mitotic program CYC140, a PLK1 inhibitor, in patients with both solid tumors and hematological malignancies. Cyclacel's strategy is to build a diversified biopharmaceutical business based on a pipeline of novel drug candidates addressing oncology and hematology indications. For additional information, please visit www.cyclacel.com.

Next runner 1.93 stop loss set. 1m float news coming. Heard it first here in action news lol…

This has been a good :"Trading Stock" will look for reentry on Monday dependent on volume levels.

HOlding it's own, well over 10,000 trades per day NOW, and $MILLIONs in dollars being traded, folks are watching , chart indicators are strong.

Lol

$CYCC Hitting the Scanners today for sure . 135,598 Trades, 21,22,265 in traded Volume , PLUS over $ 42 MILLION dollars in traded volume .
--
News out today
https://www.otcmarkets.com/stock/CYCC/news

Like there style lol.. 4,968,945 shares of common stock at a purchase price of $1.61 per share of common stock (or per pre-funded warrant in lieu thereof) and accompanying warrants in a private placement priced at-the-market under Nasdaq rules. The series A warrants and short-term series B warrants will have an exercise price of $1.36 per share and will be exercisable immediately upon issuance. The series A warrants will expire five and one-half years from the date of issuance and the short-term series B warrants will expire eighteen months from the date of issuance. The private placement is expected to close on or about May 2, 2024, subject to the satisfaction of customary closing conditions.

And……

they just announced one

https://twitter.com/Cbmcgee2/status/1783238416601137262/photo/1

No offering…The Company has determined not to pursue, at this time, the public offering to which the Registration Statement relates. The Registration Statement has not been declared effective by the Commission and no securities have been issued or sold under the Registration Statement. Accordingly, withdrawal of the Registration Statement is consistent with the public interest and the protection of investors, as contemplated by paragraph (a) of Rule 477.

The Company acknowledges that no refund will be made for fees paid to the Commission in connection with the filing of the Registration Statement. However, the Company respectfully requests, in accordance with Rule 457(p) under the Securities Act, that all fees paid to the Commission in connection with the filing of the Registration Statement be credited to the Company’s account to be offset against the filing fee for any future registration statement or registration statements.

What happened? I spent the afternoon posting new highs and lows

What leaked

CYCC under $2

What I miss?

CYCC 10Q due 3/19

while s. robotis has certainly got to be in the running for longest serving, worst performing CEO of any American company
in history, one has to admire that decade after decade he is able to draw a sizeable paycheck, while keeping his
handpicked and doubtlessly corrupt bod in his back pocket. he could teach a valuable course at any business school.
what a great subject for a great novel cycc and it's unapologetic, feckless leader would make.
go Spiro go--and you know he will do just that!

CYCC new 52 week low

how has Spiro kept his job?
is there a functioning board of directors?
he's been drawing a big salary without a single thing for an investor to feel good about for so many years. ??????

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

CYCC new 52. Week low

CYCC new 52 week low

CYCC new 52 week low

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

Nice buy

Sar Pas,

No reply to my last post! The stock is now at 73 cents. Get out while you can. It is not on fire! I can't beleive that you have not responded.

He is a scammer and it will soon be delisted or he will have to do another offering. I lost thousands years ago. It is what Spiro does. He keeps on sucking in new money so that he can live the life of luxury while we all lose our shirts. That is what he does. Everyone needs to run as fast as possible and take their loses. This guy and his board should be shut down. I can't stand to see what you are all going through! Get out Now!

So what do you have to say now? Spiro has been sucking in people for years. Prepare yourself for another reverse split so that he can keep the money rolling in. I lost thousands years ago. He is a scammer! Run!

Ihub is a valueless waste land

Stock is on fire in PM and nobody to comment ? Closed at $1.31 and was up to $1.99 in PM. Wake up people.

That was nice :) moving on.

This should be the week. See what the universe delivers on this opp. It does what it wants.

spiro rombotis. not just in the usa, but globally, he would be right at the
very top of highest paid, longest standing, and worst ceos. can't even imagine
how corrupt the board is. if he has family, not even they would've let him
keep his job. he's smart, he's very articulate, hard to imagine a bigger fraudster.
if cycc wasn't what it is, he would've been out 10 years ago. or more...

Nobody needs to be in here now. But ya’ll will be checking in here later cause we gonna blow this up

Movement PM

Enter ar 3,80, bullish by TA, regards

AH boom

just the fact that spiro and his cohort, i mean cfo, have had
their ludicrous contracts extended is enough to drop the value
of the company almost by 1/5th. the bod of cycc, they must be
some bunch. spiro, he's almost too bad to be true. smart? he is that. deserving to keep his job? oh lord love a duck. even if he
paid himself nothing instead of the ludicrous salary he is paid
he should've been ousted many years ago...

We find stuff like CYCC and, unlike the the "mud merchant" we tell you about them BEFORE they pop. This way, you've got a chance to make money and not just be sitting there after the explosion watching a video of some guy drawing arbitrary lines and pontificating about the stock might go up or it might go down.

This chart was looking fantastic June of last year.

Highs are good

CYCC hit Another New high $4.45 so far! It is heading onto $4.68 now since the Bottom was $3.12...

Another New high $4.34 today! CYCC is heading onto $20 again...

CYCC is much much much cheaper than all its COVID-19 peers now!

I hope the price stabilizes, 3 - 4$

CYCC just hit a New high $4.35 in the Pre-Market session of today! We should see $6 again as soon as tomorrow...

To replicate the Same 7.413-Bagger Strong performance with its NASDAQ-peer (HUSA), CYCC will surge to $23.13 which is 5.74 Times of its current ridiculous low price $4.03!

nice

CYCC hit $4.19 today! We should see $6 again as soon as this week...

Super Undervalued now! Hyper Oversold --- from nearly $20 to $3.12!

CYCC ~ looks okay

Yes, CYCC bounced to $3.98 today! We should see it soar back to $20 again before the end of 2020 since the company is developing COVID-2019 related hot drugs...

CYCC has Very Good News after the market close --- no more share's dilution to raise the cash till 12/31/2022!

CYCC has $4.76 per share Cash Value and $5.03 per share Book Value now!

So it is Extremely Undervalued currently! At Hyper Oversold status now --- from $19.xx to $3.12!

Thus it will Quickly And Easily surge back to its most recent high $19.xx (i.e. nearly $20) again...

CYCC might replicate 7.143-Bagger Quick rally to hit $22.29 like its NASDAQ-peer (HUSA) did!

will move up some

Yes, CYCC seems Bottomed out at $3.19! It bounced to $4.25 so far! Easy to surge back to $6.00 again since its most recent high was nearly $20.00...

north is good