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10-k filed today at the deadline. Annual Report data is available.
Mostly sellers today, but some buying at $0.0649 shows some confidence that these recent higher share prices may become the new floor.
Annual Report delay to by April 15
On March 31, OTLC filed with the SEC, saying:
The Company is working on and unable to compile the necessary financial information required to prepare a complete filing. Thus, the Company would be unable to file the annual report in a timely manner without unreasonable effort or expense. The Company expects to file within the extension period.
Oncotelic Therapeutics Announces Successful Completion of Phase 1 Trial of OT-101 and IL-2, Highlights Findings at SWCR 2025 Conference
Oncotelic Therapeutics Announces Successful Completion of Phase 1 Trial of OT-101 and IL-2, Highlights Findings at SWCR 2025 Conference
09:00 AM EDT, March 25, 2025
AGOURA HILLS, Calif., March 25, 2025 (GLOBE NEWSWIRE) -- Oncotelic Therapeutics, Inc (OTCQB:OTLC) ("Oncotelic", the "Company" or "We" or “Our”), ”), a leader in RNA-based therapeutics, announced today the successful completion of a Phase 1 clinical trial evaluating OT-101, in combination with IL-2 for advanced or metastatic solid tumors. These results set the stage for new studies that combine OT-101,an antisense therapeutic targeting Transforming Growth Factor Beta 2 (TGFß2), with checkpoint inhibitors (“CKIs”) and recombinant IL-2 (aldesleukin) (“IL-2”).
Another leg up coming? Share price may test a new bottom a little while longer before that happens. But, if “This partnership is poised to be a game-changer for our development programs..." according to Dr. Trieu, is true, we may see a string of new highs for OTLC.
Oncotelic Accesses Rapid IND Development Platform through Partnership with Medicilon
Press Release | 02/25/2025
AGOURA HILLS, Calif., Feb. 25, 2025 (GLOBE NEWSWIRE) -- Oncotelic Therapeutics, Inc. (OTCQB:OTLC). Oncotelic Therapeutics Inc., a leader in RNA-based therapeutics, including its subsidiaries (“Oncotelic”) and including Sapu Bioscience, LLC (“SAPU”), a wholly owned subsidiary of GMP Biotechnology Limited in which Oncotelic is a 45% owner, is pleased to announce a strategic partnership with Shanghai Medicilon Inc. (“Medicilon”) (stock code: 688202.SH). Through this collaboration, Oncotelic and SAPU will utilize Medicilon’s industry-leading rapid IND development platform to support up to 20 Investigational New Drug (IND) projects. Six of these INDs are ongoing and are focused on next-generation anticancer agents.
Oncotelic and SAPU's partnership with Medicilon is poised to significantly accelerate the development of our innovative oncology pipeline. This collaboration reflects our strategic move to strengthen our position as a leader in novel cancer therapies.
Enabling Rapid Growth: Medicilon’s integrated platform for drug discovery, pharmaceutical research, and preclinical development will expedite the regulatory pathways for Oncotelic’s and SAPU’s upcoming IND submissions.
Portfolio Expansion: This initiative will initially focus on the current six INDs but has the potential to extend up to 20 projects, reflecting the depth of Oncotelic’s and its affiliates’ R&D programs.
Dr. Vuong Trieu, Chairman and CEO of Oncotelic and SAPU, stated, “This partnership is poised to be a game-changer for our development programs. The ability to access a rapid IND-enabling platform is crucial for accelerating SAPU’s and Oncotelic’s development programs. We look forward to continued success working with Medicilon as we advance innovative anticancer agents to the clinic.”
Dr. Chen Chunlin, Founder and CEO of Medicilon, remarked, “We are excited to partner with Oncotelic and SAPU and contribute our international experience in drug R&D. We are a comprehensive, one-stop services organization, from early discovery to IND registration, built to accelerate the translation of Oncotelic and SAPU’s pipeline into new therapeutic options for patients.”
The SS is interesting to me. In the most recent form 3 filing, Trieu Vuong owns directly 93M shares..Autotelic owns 16M and his own spouse owns 6M of course these are all rounded, the total shares owned is almost 117 M . The number of shares held at DTC per OTC markets is 115M,.almost 116M. That means, that between these owners they own more than the entire float. Coupled with retail ownership... Whomever owns shares owns more than the float at this point. I just wonder how big it's going to go
This company is a joke! I've been in this POS for years at .25 and nothing ever happens. The only thing "in play" is a circle jerk between management.
70K shares of dead money. This so-called IPO will never happen.
From another board, scroll down to the OTLC post concerning the IPO. JMHO
https://stocktwits.com/WangSLO
I wonder if its just quiet here, and that's all
What are the benefits of being awarded orphan drug status?
There are many benefits to having ODS. In addition to eligibility for grant funding, regular input from the OOPD, and qualification for rapid FDA approval processes, other benefits include:
Prescription Drug User Fee Act (PDUFA) exemption: In 1992, the U.S. Congress created the PDUFA, which allowed the FDA to collect fees from manufacturers. The fees are important in speeding up the medication approval process. However, if the manufacturer obtains ODS, the FDA will waive the NDA or BLA application fee, which can be over $2 million.
Orphan drug tax credit: The manufacturer receives a tax credit for a percentage of qualified study costs.
Market exclusivity: The manufacturer won’t have to worry about competition on the market for 7 years.
Free pricing: The manufacturer will have the freedom to set any price on the OD.
About one yr ago. Jmo
When did they get orphan designation? Seems pretty bullish to me. Was this in a recent filing? Or is this old news?
OT-101 has been granted orphan designation by the FDA under the Orphan Drug Act ("ODA"). ODA provides for granting special status to a drug to treat a rare disease or condition upon request of a drug company.
OT-101 also been granted Rare Pediatric Designation for DIPG. The FDA grants rare pediatric disease designation for diseases with serious or life-threatening manifestations that primarily affect people aged from birth to 18 years, and that affect fewer than 200,000 people in the U.S.
Closed at .0377.
OS 406 mil
Float 115 mil. JMHO
I can’t believe others haven’t showed up here yet. I’ve seen this happen so many times though. Word gets out to the masses and BOOM!! It’s gone buddy. Then all you can say is why didn’t I load up when I had the chance.
$OTLC Monster $27.6M Cash Deal, $50,000,000 Deal coming Plus IPO »» Oncotelic’s joint venture (JV) with Dragon Overseas Capital Limited, an affiliate of Golden Mountain Partners, LLC. The JV initial focus is on the development and commercialization of OT-101, the transformative cancer drug that Oncotelic licensed to the JV for a 45% ownership. Dragon Overseas invested cash of $27.6 million for a 55% ownership of the JV.
The JV is planned to be headquartered in Hong Kong. Oncotelic could potentially receive up to $50 million following the sale of the RPD voucher once OT-101 has received marketing approval for diffuse intrinsic pontine gliomas. The JV is expected to launch an initial public offering (IPO) on the Hong Kong Stock Exchange in 2024, and CEO Dr. Vuong Trieu has said he expects the IPO to be highly successful.
$OTLC HUGE RIGHT HERE » The Company is currently developing OT-101, through its joint venture (“JV”) with Dragon Overseas Capital Limited (“Dragon”) and GMP Biotechnology Limited (“GMP Bio”), both affiliates of Golden Mountain Partners (“GMP”), for various cancers
Who's the Joint Venture Partner DRAGON CAPITAL OVERSEAS
Dragon Capital Group, an investment platform that focuses on Vietnam and other emerging Southeast Asian markets, has $6.1 billion in assets under management (AUM) as of March 31, 2024.
Our portfolio features two flagship funds: the Vietnam Enterprise Investments Limited (VEIL), a closed-end fund with over $1.8 billion AUM and listed on the London Stock Exchange
Who's the Affiliated Partner GREAT MOUNTAIN PARTNERS
Great Mountain Partners (GMP) is a private markets investor with $10 billion in assets under management. GMP's portfolio includes companies in sectors such as media and entertainment, transportation, energy, infrastructure, and financial services.
Yes, this is Primed to breakout.
So the phase 3 trial for pancreatic cancer have been completed, is that correct? And they are waiting for results?
Just the 2 PARTNERS says it's going so much higher
Dragon Capital Overseas $6B Fund and Golden Mountain Partners Funds $10 Billion
PARTNER GMP is a $10 Billion private markets investor providing its partners long-term capital solutions throughout the capital structure.
ONCOTELIC AND GOLDEN MOUNTAIN PARTNERS FORMING A JOINT VENTURE FOR IPO
Oncotelic to receive up to $50 million on sale of the RPD voucher following marketing approval of OT-101 for DIPG
Dragon Overseas has agreed to invest cash and other assets with a value of approximately $27.6 million for 55% ownership of the JV
Oncotelic has Licensed OT-101 to the JV for a 45% ownership in the JV
The Joint Venture to be headquartered in Hong Kong
Must Buy $OTLC Medical Research Gem
Last week they submitted PHASE 3 Clinical Trial Results to the #FDA for Oncotelic OT-101 against Metastatic Pancreatic Cancer - First in Class!!
Price Target $4.00 by Litchfield Hills Research otcmarkets.com/research-repor…
Amazing Pipeline ... oncotelic.com/pipeline/
Last week the CEO PURCHASED 500,000 shares at $0.02. He Purchased Almost $50,000 or 1.8m shares on the open market.
The AUDITED FINANCIALS Show Almost $30,000,000 in Assets
They just signed a Deal (8-k Signed) for $45,000,000 with another Company. $15,000,000 Cash and $30,000,000 in Shares
otcmarkets.com/filing/html?id…
Market Cap is only $10m Phase 3 Clinical Trials, it should be $100,000,000 or more easily.
They opened a state-of-the-art GMP Manufacturing Plant, a significant stride in biopharmaceutical innovation, through its joint venture Sapu Biosciences LLC Situated in San Diego biotechnology hub, this cutting-edge, AI-driven facility marks a pivotal expansion in the company's clinical pipeline, advancing beyond its OT-101 development. Discover more at sapubio.com/contact/."
An IPO is coming
This will be the second transaction for capitalizing on our assets and building shareholder value. The first being the successful transition of OT-101 to our joint venture (“JV”) with Dragon Capital Overseas, Limited. The JV is expected to list for an IPO, as well as the completion of establishing a research and manufacturing facility headquartered in San Diego, California." expressed Dr. Vuong Trieu, CEO of Oncotelic
#AITechnology
#MedicalResearch #Cancer #CureforCancer #Pancreatic #Biotechnology
$OTLC Huge 8-K $45,000,000 Deal Right here
As per the terms contained in the Term Sheet, Mosaic will pay Oncotelic $15 million in shares upon the closing of a definitive agreement for certain pre-agreed indications of CA4P. In addition, Oncotelic may earn upto $15 million in cash and $15 million in shares of Mosaic, upon achievement of certain agreed upon milestones. Additional terms of the Term Sheet include that (1) Mosiac to continue the development work necessary to achieve the mutually agreed upon milestones which will include an annual budget of $2.0 – $2.5 million,
https://www.otcmarkets.com/filing/html?id=17484592&guid=gVL-kaSFt2dfJth
OTLC must read This was $0.25 not long ago...
Price Target is $4.00+ by the Experts, not me.
So the CEO PURCHASED shares $10,000 at .02 last week, exactly when they submitted the PHASE 3 CLINICAL TRIAL RESULTS to the #FDA
They have over $30,000,000 in Assets Plus $15,000,000 in shares of $CPMV plus $15,000,000 more to come.
Realistically that's $60,000,000 in Assets with a $$10m Market Cap
IF The FDA APPROVAL is met, the revenue with be astronomical and there's huge BUYOUT Potential at stake..
Re: Submission of Clinical Trial Results Information Pursuant to 42 U.S.C. 282(j)
FDA Reference Number: CDER-2024-145
NCT02641639
Probably why CEO Trieu Purchased $10,000 in Commons last week at $0.02
https://www.otcmarkets.com/filing/html?id=17789097&guid=gVL-kaSFt2dfJth
$OTLC .026 MONSTER FIND SUBMISSION OF PHASE 3 CLINICAL TRIAL RESULT U.S. FOOD & DRUG ADMINISTRATION
VIA UNITED PARCEL SERVICE AND E-MAIL
Oncotelic Therapeutics, Inc.
Attention: Larn Hwang, Ph.D., Chief Scientific Officer
29397 Agoura Road, Suite 107
Agoura Hills, California 91301
Re: Submission of Clinical Trial Results Information Pursuant to 42 U.S.C. 282(j)
FDA Reference Number: CDER-2024-145
NCT02641639
Dear Dr. Hwang:
Based on an initial review of Food and Drug Administration (FDA) records, information from
the ClinicalTrials.gov data bank operated by the National Library of Medicine, a part of the
National Institutes of Health, and any available public information, it appears that Oncotelic
Therapeutics, Inc. (formerly Mateon Therapeutics, Inc.), is the “responsible party”1 for the
above-identified clinical trial, which appears to be an “applicable clinical trial”2 subject to the
requirements of section 801 of the Food and Drug Administration Amendments Act of 2007,
including its implementing regulations in 42 CFR part 11. A responsible party for an applicable
clinical trial is required to submit to the ClinicalTrials.gov data bank certain results information
for the clinical trial; such results information generally must be submitted no later than one
year after the primary completion date3 of the applicable clinical trial, unless the responsible
1 See sections 402(j)(1)(A)(ix) of the Public Health Service Act (PHS Act) (42 U.S.C. 282(j)(1)(A)(ix)) and 42 CFR
11.10 for the definition of “responsible party.” We recognize that Mateon Therapeutics is listed as the
responsible party for this clinical trial in ClinicalTrials.gov data bank. However, public records show that Oncotelic
Therapeutics, Inc., merged with Mateon Therapeutics, Inc. (https://www.biospace.com/article/releases/oncotelic-
therapeutics-inc-formerly-mateon-therapeutics-inc-name-and-symbol-change-/). Accordingly, Oncotelic
Therapeutics, Inc., appears to be the responsible party for this clinical trial. 2 See sections 402(j)(1)(A)(i)-(iii) of the PHS Act (42 U.S.C. 282(j)(1)(A)(i)-(iii)) and 42 CFR 11.10 for the
definition of “applicable clinical trial.” 3 See 42 CFR 11.10 for the definition of “primary completion date.” See also section 402(j)(1)(A)(v) of the PHS
Act (42 U.S.C. 282(j)(1)(A)(v)), which defines “completion date.” As reflected in 42 CFR 11.10, the terms
“primary completion date” and “completion date” are synonymous for the purposes of 42 CFR part 11.
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
w ww.fda.gov
Reference ID: 5444521
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Oncotelic is actively seeking collaborations with corporations, academic institutions, and patient groups to advance our programs.
We have a history of successful partnerships and welcome new collaboration and licensing opportunities.
Interested parties may contact:
Chulho Park PhD, Chief Technology Officer
Oncotelic Inc.
29397 Agoura Rd., Suite 107
Agoura Hills, CA 91301
bd@oncotelic.com
(650) 635-7000
Through our history of collaborative research, Mateon has supported clinical research projects in the United Kingdom (UK) led by
Cancer Research UK (CRUK) along with additional academic partners.
Currently, we are supporting the PAZOFOS study (NCT02055690), which is being led by The Christie Hospital NHS Foundation Trust
and coordinated by the Manchester Academic Health Science Centre,
Trials Coordination Unit, or MAHSC-CTU, with additional support from The University of Manchester, the Royal Marsden NHS Foundation Trust,
and Mount Vernon Cancer Centre (part of the East and North Hertfordshire NHS Trust).
This Phase 1b/2 study is evaluating the combination of CA4P (fosbretabulin) with the tyrosine kinase inhibitor pazopanib (Votrient®) versus pazopanib
alone for the treatment of advanced recurrent ovarian cancer.
We are providing CA4P for use in this trial.
Continuing in our history of collaborative research, Mateon is providing investigational drug to the Markey Cancer Center for their study Study MCC-2016-08 (NCT03014297).
The study is designed as a single center, open label, phase 1 clinical trial for patients with grade 1-3 gastroenteropancreatic neuroendocrine tumors.
In the first part of the study, up to 15 patients will be treated with everolimus in combination with two different dosing regimens of
CA4P to establish appropriate CA4P dosing levels and evaluate the safety of the drug combination.
The second part of the study is designed to enroll 15 additional patients for assessment of additional safety and efficacy data.
Patients enrolled in MCC-2016-088 will be treated with CA4P and everolimus for 12 weeks.
We are committed to leveraging our intellectual property and the product development expertise of our highly experienced management team to enable
vascular targeted therapy to realize its true potential and to bring much needed new therapies for orphan oncology indications to cancer patients worldwide.
We have a portfolio of preclinical and clinical stage candidates focused on areas of significant unmet need that we believe can bring significant value to our shareholders.
Our common stock is traded on the OTCQB Market under the symbol “MATN”.
We are headquartered in Agoura Hills, California
https://www.oncotelic.com/pointr-data/
EdgePoint AI was established in order to advance the company’s revolutionary cluster-computer platform for AI that processes machine learning
models at a fraction of the power and budget of mainstream computing in pharmaceutical manufacturing.
The company’s technology solution “TrustPoint” provides an AI computing platform for pharmaceutical and healthcare verticals
including blockchain support for manufacturing where data integrity and security are of utmost importance.
EdgePoint is composed of a team of executives with pharmaceutical drug development, GMP manufacturing and deep AI knowledge.
The team includes Steven King who was the former CEO of Peregrine Pharmaceuticals, Inc. (NASDAQ) and its wholly-owned
contract biomanufacturing subsidiary Avid Bioservices, Inc., for over 15 years, during which time the company advanced its
lead compound through Phase 3 development, while growing revenues to over $55 million;
Seasoned executive, Saran Saund who has been founder, CEO and GM at several startups and public companies for which he returned
significant value to shareholders in his startups and chief technology officer; Burcak Beser who has been founder and
CTO of several successful private and public companies with over 144 patents during his career; and Lisa Stepp with broad experience in
executive leadership across geographies and in all aspects of drug development and program management.
The core technology platform for EdgePoint AI came from PointR -which was acquired by Mateon in Nov 2019. Examples of PointR capabilities are shown below.
http://oncotelic.com/wp-content/uploads/LosAngelesBusinessJournal2018-05-21.pdf
Health Care: Drug Developer Adds Digital Monitor
TWO YEAR CHART: NASDAQ
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02-07-2021
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