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$OTLC .14 Huge DD $1 Billion -$2 Billion IPO, $50M License Agreement, 106m Shares Locked by Insiders, $10m Purchase Agreement for Common Shares by Investor. A Pipeline Valued in the $100's of Millions. 2 Cancer Drugs Granted EMERGENCY USE by the FDA, ArtiVeda ™ granted Emergency Use in India for COVID-19, backed by Windlas Biotech, AI/Blockchain Program backed by IBM Watson Health.
$OTLC .14 Target by Company 700% to $1400% Or $2.60 to $5.20 PPS
$OTLC .14 Target by Company 700% to $1400% Or $2.60 to $5.20 PPS
$OTLC .14 Target by Company 700% to $1400% Or $2.60 to $5.20 PPS
Quick DD, $1 Billion -$2 Billion IPO, $50M License Agreement, 106m Shares Locked by Insiders, $10m Purchase Agreement for Common Shares by Investor. A Pipeline Valued in the $100's of Millions. 2 Cancer Drugs Granted EMERGENCY USE by the FDA, ArtiVeda ™ granted Emergency Use in India for COVID-19, backed by Windlas Biotech, AI/Blockchain Program backed by IBM Watson Health, and so much more.
$OTLC .14 READ $1 Billion -$2 Billion IPO, $50M License Agreement, 106m Shares Locked by Insiders, $10m Purchase Agreement for Common Shares by Investor. A Pipeline Valued in the $100's of Millions. 2 Cancer Drugs Granted EMERGENCY USE by the FDA, ArtiVeda ™ granted Emergency Use in India for COVID-19, backed by Windlas Biotech, AI/Blockchain Program backed by IBM Watson Health.
$OTLC .14 READ $1 Billion -$2 Billion IPO, $50M License Agreement, 106m Shares Locked by Insiders, $10m Purchase Agreement for Common Shares by Investor. A Pipeline Valued in the $100's of Millions. 2 Cancer Drugs Granted EMERGENCY USE by the FDA, ArtiVeda ™ granted Emergency Use in India for COVID-19, backed by Windlas Biotech, AI/Blockchain Program backed by IBM Watson Health.
$OTLC .14 $1 Billion -$2 Billion IPO, $50M License Agreement, 106m Shares Kicked by Insiders,
$OTLC .14 $1 Billion -$2 Billion IPO, $50M License Agreement, 106m Shares Kicked by Insiders,
$OTLC 8-K, $50,000,000 License Agreement https://www.otcmarkets.com/filing/html?id=15209427&guid=Dsm9kq6Mr6ISZth
$OTLC .14 8-K out, $50,000,000 License Agreement https://www.otcmarkets.com/filing/html?id=15209427&guid=Dsm9kq6Mr6ISZth
$OTLC .14 8-K out, $50,000,000 License Agreement https://www.otcmarkets.com/filing/html?id=15209427&guid=Dsm9kq6Mr6ISZth
$OTLC .142 Huge 8-K, Uplifting to NYSE/NASDAQ and IPO to the HONG KONG EXCHANGE
$OTLC .142 Huge 8-K, Uplifting to NYSE/NASDAQ and IPO to the HONG KONG EXCHANGE
$OTLC .145 HUGE 8-K OUT >> https://www.otcmarkets.com/filing/html?id=15209427&guid=Dsm9kq6Mr6ISZth
$OTLC .145 HUGE 8-K OUT >> https://www.otcmarkets.com/filing/html?id=15209427&guid=Dsm9kq6Mr6ISZth
$OTLC IPO OFFERING $1 Billion to $2 Billion Valuation
Currently $50,000,000 Market Cap UNREAL
Recent Biotechnology IPO
Pliant Biopharma $PLRX $19/share $170m Raise
Genor Biopharma 11.50/share $370m Raise
Scholar Rock $SRRK $39/share $75m Raise
Original PPS $11.00
HUge news >> PulmoHealTM/ ArtiVedaTM is effective against COVID-19 variants.
The study report will serve as the basis for Oncotelic’s regulatory submission for marketing approval of PulmoHealTM/ ArtiVedaTM.
https://www.otcmarkets.com/stock/OTLC/news/PULMOHEAL-ARTIVEDA-IS-CLINICALLY-ACTIVE-AGAINST-MILD-AND-MODERATE-COVID-19?id=317712
$OTLC .14 Holy Huge EFFECTIVE DRUG AGAINST ALL COVID VARIANTS >> PULMOHEAL™/ ARTIVEDA™ IS CLINICALLY ACTIVE AGAINST MILD AND MODERATE COVID-19.Press Release | 08/24/2021
AGOURA HILLS, Calif., Aug. 24, 2021 (GLOBE NEWSWIRE) -- Oncotelic Therapeutics, Inc. ("Oncotelic" or the "Company") (OTCQB:OTLC), a leading developer of TGF-ß therapeutics for oncology and COVID-19, reported today that PulmoHealTM/ ArtiVedaTM has proven active against mild and moderate COVID-19 following the preplanned prospective analysis of ARTI-19 clinical trial (NCT05004753- A Prospective, Randomized, Multi-center, Open label, Interventional Study to Evaluate the Safety and Efficacy of Artemisinin 500 mg capsule in Treatment of Adult Subjects with COVID-19). The study report will serve as the basis for Oncotelic’s regulatory submission for marketing approval of PulmoHealTM/ ArtiVedaTM.
"The positive outcome of this well conducted clinical trial has validated our TGF-ß platform against COVID-19. Targeting the immutable host protein, PulmoHealTM/ ArtiVedaTM is effective against COVID-19 variants. We look forward to continuing expansion of our marketing of PulmoHealTM/ ArtiVedaTM as phytomedicine and further clinical development of Artemisinin as a pharmaceutical." said Dr. Vuong Trieu, CEO and Chairman of Oncotelic.
In summary, based on the study results, it was shown that Artemisinin 500 mg capsule administered once daily for 5 days:
was effective in treating subjects with mild and moderate COVID-19,
artemisinin+SOC group showed significant improvement over SOC in WHO severity scale on Day 4 and Day 5 with p=0.0045 and p=0.0370, respectively.
decline in body temperature was faster and higher in Artemisnin+SOC group by day 2 in comparison to SOC arm,
improvement in respiratory rate was faster and higher in Artemisnin+SOC group by day 5 in comparison to SOC arm,
improvement in mean SpO2 level was significantly higher in Artemisnin+SOC group by day 28 (end of study) in comparison to SOC arm (p=0.029),
no clinically significant changes in biochemistry or hematology parameters,
was safe and well-tolerated by the study subjects.
About ARTI-19
NCT05004753- A Prospective, Randomized, Multi-center, Open label, Interventional Study to Evaluate the Safety and Efficacy of Artemisinin 500 mg capsule in Treatment of Adult Subjects with COVID-19. This was an open label, prospective, multicenter study. Subjects with a clinical diagnosis of mild to moderate COVID-19, subject to fulfilling other inclusion and exclusion criteria, were randomized to receive either SOC or test drug Artemisinin 500 mg capsule/day for 5 days + standard of care (SOC) per cycle with the option to repeat as needed until symptoms of the disease are resolved, up to a total of 3 cycles (“5 days treatment, 5 days off" comprise a cycle) or standard of care (SOC).
The subjects were randomly assigned and received treatment with either the test plus SOC (n=80) or the SOC (n=41). After having obtained signed, written Informed Consent, these subjects had undergone a screening examination. Provided all inclusion/exclusion criteria were fulfilled, the subjects were enrolled and randomized by block randomization to one of the two treatment arms on Day 1. All the subjects had received the usual treatment according to ICMR (Indian Council of Medical Research) and other Indian ministry of healthcare guidelines.
Assessments of safety and efficacy variables were performed as per the study protocol. The final visit end of study (EOS) was on Day 28. Serious AEs were followed-up until they resolve or get stabilized or until 30 days from the subject’s involvement in the study had ended, whichever occurred first, and it was documented according to ICH-GCP and Indian GCP guidelines
Over all 122 patients were screened. The subjects were randomly assigned to one of the two groups: Artemisinin 500 mg (BD) with SOC or SOC in a ratio of 2:1.
Subjects were initially hospitalized for 5 days of study treatment in both treatment arms. When necessary, subjects were permitted to remain for a few more additional days in the hospital for the second cycle or third cycle of treatment.
About Oncotelic Therapeutics
Oncotelic Therapeutics, Inc. (f/k/a Mateon Therapeutics, Inc.) ("Oncotelic"), was formed in the State of New York in 1988 as OXiGENE, Inc., was reincorporated in the State of Delaware in 1992, and changed its name to Mateon Therapeutics, Inc. in 2016, and Oncotelic Therapeutics, Inc. in November 2020.
Oncotelic was created by the 2019 merger with Oncotelic Inc., which became a wholly owned subsidiary of Mateon, thereby creating an immuno-oncology company dedicated to the development of first in class RNA therapeutics, as well as small molecule drugs against cancer and infectious diseases. OT-101, the lead immuno-oncology drug candidate of Oncotelic, is a first-in-class anti-TGF-ß RNA therapeutic that exhibited single agent activity in some relapsed/refractory cancer patients in clinical trial settings. OT-101 also has shown activity against SARS-CoV-2. Oncotelic is seeking to leverage its deep expertise in oncology drug development to improve treatment outcomes and survival of cancer patients with a special emphasis on rare pediatric cancers. Oncotelic also has rare pediatric designation for DIPG (OT-101), melanoma (CA4P), and AML (OXi 4503). The Company acquired PointR Data Inc. ("PointR") in November 2019. The PointR Acquisition was intended to create a publicly traded artificial intelligence driven immuno-oncology company with a robust pipeline of first in class TGF-ß immunotherapies for late-stage cancers such as gliomas, pancreatic cancer and melanoma.
For more information, please visit www.oncotelic.com and www.mateon.com.
$OTLC .14 Holy Huge EFFECTIVE DRUG AGAINST ALL COVID VARIANTS >> PULMOHEAL™/ ARTIVEDA™ IS CLINICALLY ACTIVE AGAINST MILD AND MODERATE COVID-19.Press Release | 08/24/2021
AGOURA HILLS, Calif., Aug. 24, 2021 (GLOBE NEWSWIRE) -- Oncotelic Therapeutics, Inc. ("Oncotelic" or the "Company") (OTCQB:OTLC), a leading developer of TGF-ß therapeutics for oncology and COVID-19, reported today that PulmoHealTM/ ArtiVedaTM has proven active against mild and moderate COVID-19 following the preplanned prospective analysis of ARTI-19 clinical trial (NCT05004753- A Prospective, Randomized, Multi-center, Open label, Interventional Study to Evaluate the Safety and Efficacy of Artemisinin 500 mg capsule in Treatment of Adult Subjects with COVID-19). The study report will serve as the basis for Oncotelic’s regulatory submission for marketing approval of PulmoHealTM/ ArtiVedaTM.
"The positive outcome of this well conducted clinical trial has validated our TGF-ß platform against COVID-19. Targeting the immutable host protein, PulmoHealTM/ ArtiVedaTM is effective against COVID-19 variants. We look forward to continuing expansion of our marketing of PulmoHealTM/ ArtiVedaTM as phytomedicine and further clinical development of Artemisinin as a pharmaceutical." said Dr. Vuong Trieu, CEO and Chairman of Oncotelic.
In summary, based on the study results, it was shown that Artemisinin 500 mg capsule administered once daily for 5 days:
was effective in treating subjects with mild and moderate COVID-19,
artemisinin+SOC group showed significant improvement over SOC in WHO severity scale on Day 4 and Day 5 with p=0.0045 and p=0.0370, respectively.
decline in body temperature was faster and higher in Artemisnin+SOC group by day 2 in comparison to SOC arm,
improvement in respiratory rate was faster and higher in Artemisnin+SOC group by day 5 in comparison to SOC arm,
improvement in mean SpO2 level was significantly higher in Artemisnin+SOC group by day 28 (end of study) in comparison to SOC arm (p=0.029),
no clinically significant changes in biochemistry or hematology parameters,
was safe and well-tolerated by the study subjects.
About ARTI-19
NCT05004753- A Prospective, Randomized, Multi-center, Open label, Interventional Study to Evaluate the Safety and Efficacy of Artemisinin 500 mg capsule in Treatment of Adult Subjects with COVID-19. This was an open label, prospective, multicenter study. Subjects with a clinical diagnosis of mild to moderate COVID-19, subject to fulfilling other inclusion and exclusion criteria, were randomized to receive either SOC or test drug Artemisinin 500 mg capsule/day for 5 days + standard of care (SOC) per cycle with the option to repeat as needed until symptoms of the disease are resolved, up to a total of 3 cycles (“5 days treatment, 5 days off" comprise a cycle) or standard of care (SOC).
The subjects were randomly assigned and received treatment with either the test plus SOC (n=80) or the SOC (n=41). After having obtained signed, written Informed Consent, these subjects had undergone a screening examination. Provided all inclusion/exclusion criteria were fulfilled, the subjects were enrolled and randomized by block randomization to one of the two treatment arms on Day 1. All the subjects had received the usual treatment according to ICMR (Indian Council of Medical Research) and other Indian ministry of healthcare guidelines.
Assessments of safety and efficacy variables were performed as per the study protocol. The final visit end of study (EOS) was on Day 28. Serious AEs were followed-up until they resolve or get stabilized or until 30 days from the subject’s involvement in the study had ended, whichever occurred first, and it was documented according to ICH-GCP and Indian GCP guidelines
Over all 122 patients were screened. The subjects were randomly assigned to one of the two groups: Artemisinin 500 mg (BD) with SOC or SOC in a ratio of 2:1.
Subjects were initially hospitalized for 5 days of study treatment in both treatment arms. When necessary, subjects were permitted to remain for a few more additional days in the hospital for the second cycle or third cycle of treatment.
About Oncotelic Therapeutics
Oncotelic Therapeutics, Inc. (f/k/a Mateon Therapeutics, Inc.) ("Oncotelic"), was formed in the State of New York in 1988 as OXiGENE, Inc., was reincorporated in the State of Delaware in 1992, and changed its name to Mateon Therapeutics, Inc. in 2016, and Oncotelic Therapeutics, Inc. in November 2020.
Oncotelic was created by the 2019 merger with Oncotelic Inc., which became a wholly owned subsidiary of Mateon, thereby creating an immuno-oncology company dedicated to the development of first in class RNA therapeutics, as well as small molecule drugs against cancer and infectious diseases. OT-101, the lead immuno-oncology drug candidate of Oncotelic, is a first-in-class anti-TGF-ß RNA therapeutic that exhibited single agent activity in some relapsed/refractory cancer patients in clinical trial settings. OT-101 also has shown activity against SARS-CoV-2. Oncotelic is seeking to leverage its deep expertise in oncology drug development to improve treatment outcomes and survival of cancer patients with a special emphasis on rare pediatric cancers. Oncotelic also has rare pediatric designation for DIPG (OT-101), melanoma (CA4P), and AML (OXi 4503). The Company acquired PointR Data Inc. ("PointR") in November 2019. The PointR Acquisition was intended to create a publicly traded artificial intelligence driven immuno-oncology company with a robust pipeline of first in class TGF-ß immunotherapies for late-stage cancers such as gliomas, pancreatic cancer and melanoma.
For more information, please visit www.oncotelic.com and www.mateon.com.
$OTLC .14 Biggest IPO of Year
$OTLC .14 Biggest IPO of Year
$OTLC .14 6 Form 4s 106,000,000 Locked up by Insiders
$OTLC .14 6 Form 4s 106,000,000 Locked up by Insiders
$OTLC Must IPO SEPTEMBER 30TH >>
VALUATION of IPO
$1 Billion to $2 Billion
Current Market Cap
$50 Million
Projected PPS at time of IPO
$2.60 - $5.20
Valuation of Assets at time of IPO
$350 Million - $700 Milion
Shareholders Equity
$0.95 - 1.89
Lifechanger
https://www.otcmarkets.com/filing/html?id=15168688&guid=4P49knkwjUuavth
$OTLC Must IPO SEPTEMBER 30TH >>
VALUATION of IPO
$1 Billion to $2 Billion
Current Market Cap
$50 Million
Projected PPS at time of IPO
$2.60 - $5.20
Valuation of Assets at time of IPO
$350 Million - $700 Milion
Shareholders Equity
$0.95 - 1.89
Lifechanger
https://www.otcmarkets.com/filing/html?id=15168688&guid=4P49knkwjUuavth
$OTLC Must IPO SEPTEMBER 30TH >>
VALUATION of IPO
$1 Billion to $2 Billion
Current Market Cap
$50 Million
Projected PPS at time of IPO
$2.60 - $5.20
Valuation of Assets at time of IPO
$350 Million - $700 Milion
Shareholders Equity
$0.95 - 1.89
Lifechanger
https://www.otcmarkets.com/filing/html?id=15168688&guid=4P49knkwjUuavth
Must Read IPO SEPTEMBER 30TH >>
VALUATION of IPO
$1 Billion to $2 Billion
Current Market Cap
$50 Million
Projected PPS at time of IPO
$2.60 - $5.20
Valuation of Assets at time of IPO
$350 Million - $700 Milion
Shareholders Equity
$0.95 - 1.89
Lifechanger
https://www.otcmarkets.com/filing/html?id=15168688&guid=4P49knkwjUuavth
$OTLC Huge Acquisition News >> ONCOTELIC TO ACQUIRE LATE-STAGE DRUG CANDIDATE FOR PARKINSON DISEASE, ERECTILE DYSFUNCTION, AND FEMALE SEXUAL DYSFUNCTION.
Press Release | 09/01/2021
AGOURA HILLS, Calif., Sept. 01, 2021 (GLOBE NEWSWIRE) -- Oncotelic Therapeutics, Inc. ("Oncotelic" or the "Company") (OTCQB:OTLC), executed a binding term sheet with Autotelic Inc. to license AL-101 (intranasal apomorphine). Oncotelic intends to develop AL-101 via fast-to-market 505(b)2 regulatory pathway for Parkinson Disease (“PD”) and Erectile Dysfunction (“ED”), especially phosphodiesterase 5 (“PDE5”) non-responders. AL-101 will also be developed as a new drug against Female Sexual Dysfunction (“FSD”), including Hypoactive Sexual Desire Disorder (“HSDD”). AL-101 has a favorable safety and efficacy profile and is phase 3 ready with six clinical trials completed and over 200 patients (2,200 doses) treated.
"The acquisition of AL-101, expands Oncotelic’s product portfolio to the fast to market 505(b)2 regulatory pathway. AL-101 has many of the same properties necessary to replicate the successes I had with the 505(b)2 route for Abraxane at Abraxis and Cynviloq at Igdrasol. I am impressed with its marked improvement on quality of life for PD patients and look forward to working with pts and healthcare professionals in PD.” said Dr. Vuong Trieu, CEO and Chairman of Oncotelic.
About Parkinson Disease (PD):
Over 60,000 new patients being diagnosed with PD in the United States and currently there are over 1 million patients in the US and expected to increase to over 1.2 million by 2030. In addition, approximately 10 million suffer from this disease globally. https://www.parkinson.org/Understanding-Parkinsons/Statistics.
On May 2020, KYNMOBI™ (apomorphine HCI) sublingual film developed by Sunovion Pharmaceuticals was approved through the 505(b)2 pathway for acute, intermittent treatment of OFF episodes in patients with Parkinson’s disease (PD) dissolves under the tongue. Per Suniovion Pharmaceuticals, KYNMOBI is expected to generate $219 million annually. https://www.pharmaceutical-technology.com/comment/sunovion-pharmaceuticals-kynmobi-parkinsons/
About Erectile Dysfunction (ED)
ED is the most prevalent male sexual disorder globally. The market will continue to grow due to increased vascular disorders followed by the aging population across the world. Furthermore, rising psychological problems, followed by chronic diseases like diabetes, alcohol, and smoking habits are also considered as one of the major driving factors for the growth of the market. Oral PDE5 inhibitors, especially Viagra, Cialis, and Levitra, dominated the market with around US$3.8 billion of revenue in 2020.
The percentages of men affected by ED are as follows: 14.3-70% of men aged ≥60 years, 6.7-48% of men aged ≥70 years, and 38% of men aged ≥80 years (Geerkens MJM et al. (2019). Eur Urol Focus. pii: S2405-4569(19)30079-3). However, with the increasing administration of PDE5 inhibitors in clinical practice, it was found that approximately 30-35% of ED patients are treatment failures (McMahon CN et al. (2006). BMJ, 332: 589-92). AL-101 is designed to target treatment failure ED patients who do not respond to PDE5 inhibitors.
About Female Sexual Dysfunction (FSD):
Female sexual dysfunction is a prevalent problem, afflicting approximately 40% of women and there are few treatment options. FSD is more typical as women age and is a progressive and widespread condition. (Allahdadi, KJ et al. (2009) Cardiovascular & hematological agents in medicinal chemistry, 7(4), 260–269).
HSDD is characterized by a low sexual desire, that causes marked distress or interpersonal difficulty, and is not due to a co-existing medical or psychiatric condition, problems within the relationship or the effects of a medication or other drug substance. HSDD affects approximately 5.8 million U.S. premenopausal women (1 in 10 premenopausal women). Almost 98%, approximately 5.7 million of affected premenopausal women are not on any therapy for HSDD, either due to lack of education or lack of therapies available. One in 10 premenopausal women have low desire with associated distress.
There is no available drug for the treatment of FSD. In June 2019, the U.S. Food and Drug Administration approved Vyleesi (bremelanotide) to treat acquired, generalized hypoactive sexual desire disorder in premenopausal women. This is the only available drug treatment. Vyleesi has essentially replaced the only other drug for HSDD - however, it has a long list of drug-drug interactions, including commonly used antidepressants, such as fluoxetine and sertraline. In addition, it has a black box warning regarding its use with alcohol, a combination that has been associated with hypotension and syncopal episodes. Therefore there is an urgent need for effective therapy against FSD and HSDD.
About Oncotelic Therapeutics
Oncotelic Therapeutics, Inc. (f/k/a Mateon Therapeutics, Inc.) ("Oncotelic"), was formed in the State of New York in 1988 as OXiGENE, Inc., was reincorporated in the State of Delaware in 1992, and changed its name to Mateon Therapeutics, Inc. in 2016, and Oncotelic Therapeutics, Inc. in November 2020.
Oncotelic was created by the 2019 merger with Oncotelic Inc., which became a wholly owned subsidiary of Mateon, thereby creating an immuno-oncology company dedicated to the development of first in class RNA therapeutics, as well as small molecule drugs against cancer and infectious diseases. OT-101, the lead immuno-oncology drug candidate of Oncotelic, is a first-in-class anti-TGF-ß RNA therapeutic that exhibited single agent activity in some relapsed/refractory cancer patients in clinical trial settings. Oncotelic is seeking to leverage its deep expertise in oncology drug development to improve treatment outcomes and survival of cancer patients with a special emphasis on rare pediatric cancers. Oncotelic also has rare pediatric designation for DIPG (OT-101), melanoma (CA4P), and AML (OXi 4503). The Company acquired PointR Data Inc. ("PointR") in November 2019. The PointR Acquisition was intended to create a publicly traded artificial intelligence driven immuno-oncology company with a robust pipeline of first in class TGF-ß immunotherapies for late-stage cancers such as gliomas, pancreatic cancer and melanoma.
For more information, please visit www.oncotelic.com.
Oncotelic's Cautionary Note on Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical facts, included in this communication regarding strategy, future operations, future financial position, prospects, plans and objectives of management are forward-looking statements. Words such as "may", "expect", "anticipate" "hope", "vision", "optimism", "design", "exciting", "promising", "will", "conviction", "estimate," "intend," "believe", "quest for a cure of cancer", "innovation-driven", "paradigm-shift", "high scientific merit", "impact potential" and similar expressions are intended to identify forward-looking statements. Forward looking statements contained in this press release include, but are not limited to, statements about future plans, the progress, timing, clinical development, scope and success of future clinical trials, the reporting of clinical data for the company's product candidates and the potential use of the company's product candidates to treat various cancer indications. Each of these forward-looking statements involves risks and uncertainties, and actual results may differ materially from these forward-looking statements. Many factors may cause differences between current expectations and actual results, including unexpected safety or efficacy data observed during preclinical or clinical studies, clinical trial site activation or enrollment rates that are lower than expected, changes in expected or existing competition, changes in the regulatory environment, failure of collaborators to support or advance collaborations or product candidates and unexpected litigation or other disputes. These risks are not exhaustive, the company faces known and unknown risks, including the risk factors described in the Company's annual report on Form 10-K filed with the SEC on May 20, 2020 and in the company's other periodic filings. Forward-looking statements are based on expectations and assumptions as of the date of this press release. Except as required by law, the company does not assume any obligation to update forward-looking statements contained herein to reflect any change in expectations, whether as a result of new information future events, or otherwise.
Contact Information:
For Oncotelic Therapeutics, Inc.:
Amit Shah
ashah@oncotelic.com
$OTLC Huge Acquisition News >> ONCOTELIC TO ACQUIRE LATE-STAGE DRUG CANDIDATE FOR PARKINSON DISEASE, ERECTILE DYSFUNCTION, AND FEMALE SEXUAL DYSFUNCTION.
Press Release | 09/01/2021
AGOURA HILLS, Calif., Sept. 01, 2021 (GLOBE NEWSWIRE) -- Oncotelic Therapeutics, Inc. ("Oncotelic" or the "Company") (OTCQB:OTLC), executed a binding term sheet with Autotelic Inc. to license AL-101 (intranasal apomorphine). Oncotelic intends to develop AL-101 via fast-to-market 505(b)2 regulatory pathway for Parkinson Disease (“PD”) and Erectile Dysfunction (“ED”), especially phosphodiesterase 5 (“PDE5”) non-responders. AL-101 will also be developed as a new drug against Female Sexual Dysfunction (“FSD”), including Hypoactive Sexual Desire Disorder (“HSDD”). AL-101 has a favorable safety and efficacy profile and is phase 3 ready with six clinical trials completed and over 200 patients (2,200 doses) treated.
"The acquisition of AL-101, expands Oncotelic’s product portfolio to the fast to market 505(b)2 regulatory pathway. AL-101 has many of the same properties necessary to replicate the successes I had with the 505(b)2 route for Abraxane at Abraxis and Cynviloq at Igdrasol. I am impressed with its marked improvement on quality of life for PD patients and look forward to working with pts and healthcare professionals in PD.” said Dr. Vuong Trieu, CEO and Chairman of Oncotelic.
About Parkinson Disease (PD):
Over 60,000 new patients being diagnosed with PD in the United States and currently there are over 1 million patients in the US and expected to increase to over 1.2 million by 2030. In addition, approximately 10 million suffer from this disease globally. https://www.parkinson.org/Understanding-Parkinsons/Statistics.
On May 2020, KYNMOBI™ (apomorphine HCI) sublingual film developed by Sunovion Pharmaceuticals was approved through the 505(b)2 pathway for acute, intermittent treatment of OFF episodes in patients with Parkinson’s disease (PD) dissolves under the tongue. Per Suniovion Pharmaceuticals, KYNMOBI is expected to generate $219 million annually. https://www.pharmaceutical-technology.com/comment/sunovion-pharmaceuticals-kynmobi-parkinsons/
About Erectile Dysfunction (ED)
ED is the most prevalent male sexual disorder globally. The market will continue to grow due to increased vascular disorders followed by the aging population across the world. Furthermore, rising psychological problems, followed by chronic diseases like diabetes, alcohol, and smoking habits are also considered as one of the major driving factors for the growth of the market. Oral PDE5 inhibitors, especially Viagra, Cialis, and Levitra, dominated the market with around US$3.8 billion of revenue in 2020.
The percentages of men affected by ED are as follows: 14.3-70% of men aged ≥60 years, 6.7-48% of men aged ≥70 years, and 38% of men aged ≥80 years (Geerkens MJM et al. (2019). Eur Urol Focus. pii: S2405-4569(19)30079-3). However, with the increasing administration of PDE5 inhibitors in clinical practice, it was found that approximately 30-35% of ED patients are treatment failures (McMahon CN et al. (2006). BMJ, 332: 589-92). AL-101 is designed to target treatment failure ED patients who do not respond to PDE5 inhibitors.
About Female Sexual Dysfunction (FSD):
Female sexual dysfunction is a prevalent problem, afflicting approximately 40% of women and there are few treatment options. FSD is more typical as women age and is a progressive and widespread condition. (Allahdadi, KJ et al. (2009) Cardiovascular & hematological agents in medicinal chemistry, 7(4), 260–269).
HSDD is characterized by a low sexual desire, that causes marked distress or interpersonal difficulty, and is not due to a co-existing medical or psychiatric condition, problems within the relationship or the effects of a medication or other drug substance. HSDD affects approximately 5.8 million U.S. premenopausal women (1 in 10 premenopausal women). Almost 98%, approximately 5.7 million of affected premenopausal women are not on any therapy for HSDD, either due to lack of education or lack of therapies available. One in 10 premenopausal women have low desire with associated distress.
There is no available drug for the treatment of FSD. In June 2019, the U.S. Food and Drug Administration approved Vyleesi (bremelanotide) to treat acquired, generalized hypoactive sexual desire disorder in premenopausal women. This is the only available drug treatment. Vyleesi has essentially replaced the only other drug for HSDD - however, it has a long list of drug-drug interactions, including commonly used antidepressants, such as fluoxetine and sertraline. In addition, it has a black box warning regarding its use with alcohol, a combination that has been associated with hypotension and syncopal episodes. Therefore there is an urgent need for effective therapy against FSD and HSDD.
About Oncotelic Therapeutics
Oncotelic Therapeutics, Inc. (f/k/a Mateon Therapeutics, Inc.) ("Oncotelic"), was formed in the State of New York in 1988 as OXiGENE, Inc., was reincorporated in the State of Delaware in 1992, and changed its name to Mateon Therapeutics, Inc. in 2016, and Oncotelic Therapeutics, Inc. in November 2020.
Oncotelic was created by the 2019 merger with Oncotelic Inc., which became a wholly owned subsidiary of Mateon, thereby creating an immuno-oncology company dedicated to the development of first in class RNA therapeutics, as well as small molecule drugs against cancer and infectious diseases. OT-101, the lead immuno-oncology drug candidate of Oncotelic, is a first-in-class anti-TGF-ß RNA therapeutic that exhibited single agent activity in some relapsed/refractory cancer patients in clinical trial settings. Oncotelic is seeking to leverage its deep expertise in oncology drug development to improve treatment outcomes and survival of cancer patients with a special emphasis on rare pediatric cancers. Oncotelic also has rare pediatric designation for DIPG (OT-101), melanoma (CA4P), and AML (OXi 4503). The Company acquired PointR Data Inc. ("PointR") in November 2019. The PointR Acquisition was intended to create a publicly traded artificial intelligence driven immuno-oncology company with a robust pipeline of first in class TGF-ß immunotherapies for late-stage cancers such as gliomas, pancreatic cancer and melanoma.
For more information, please visit www.oncotelic.com.
Oncotelic's Cautionary Note on Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical facts, included in this communication regarding strategy, future operations, future financial position, prospects, plans and objectives of management are forward-looking statements. Words such as "may", "expect", "anticipate" "hope", "vision", "optimism", "design", "exciting", "promising", "will", "conviction", "estimate," "intend," "believe", "quest for a cure of cancer", "innovation-driven", "paradigm-shift", "high scientific merit", "impact potential" and similar expressions are intended to identify forward-looking statements. Forward looking statements contained in this press release include, but are not limited to, statements about future plans, the progress, timing, clinical development, scope and success of future clinical trials, the reporting of clinical data for the company's product candidates and the potential use of the company's product candidates to treat various cancer indications. Each of these forward-looking statements involves risks and uncertainties, and actual results may differ materially from these forward-looking statements. Many factors may cause differences between current expectations and actual results, including unexpected safety or efficacy data observed during preclinical or clinical studies, clinical trial site activation or enrollment rates that are lower than expected, changes in expected or existing competition, changes in the regulatory environment, failure of collaborators to support or advance collaborations or product candidates and unexpected litigation or other disputes. These risks are not exhaustive, the company faces known and unknown risks, including the risk factors described in the Company's annual report on Form 10-K filed with the SEC on May 20, 2020 and in the company's other periodic filings. Forward-looking statements are based on expectations and assumptions as of the date of this press release. Except as required by law, the company does not assume any obligation to update forward-looking statements contained herein to reflect any change in expectations, whether as a result of new information future events, or otherwise.
Contact Information:
For Oncotelic Therapeutics, Inc.:
Amit Shah
ashah@oncotelic.com
$OTLC The Definitive Agreement for the $1Billion to $2 Billion IPO will be Released at the End of SEPTEMBER
$OTLC .14 Monster IPO End Of SEPTEMBER >>
The JV is between GMP, the Company and Dr. Trieu
The JV shall be fully funded by GMP
Dr. Trieu will lead manufacturing to support the commercialization of the Oncotelic’s assets as well as building out a pipeline of fast to market portfolio of drugs
The Company will provide its oncology/infectious disease pipeline
The IPO will be set up on the Hong Kong or other stock exchange.
The valuation of the IPO could be in the range of $1-2 Billion based on other comparables i.e. Genor Biopharma (HKEX: 6998), Pliant Therapeutics (Nasdaq:PLRX) and ScholarRock (Nasdaq:SRRK)
Assuming the valuation above is achieved, and with the proposed 35% ownership of the JV by the Company this could potentially translate into $350-700M in asset for the Company.
All this would be achieved without any dilution to the Company shareholders.
The proposed terms are being finalized as part of the definitive agreement within the next 45 days for shareholder approval.
This is the most transformative transaction for the company since its inception. We strongly recommend approval.
There is a standstill agreement in place for 45 days wherein the Company has agreed not to continue discussion of other competing transactions.
In consideration of standing still, GMP shall infuse $1.5 Million into the Company to support C001 clinical trial evaluating OT-101 against COVID-19
$OTLC .14 Monster IPO End Of SEPTEMBER >>
The JV is between GMP, the Company and Dr. Trieu
The JV shall be fully funded by GMP
Dr. Trieu will lead manufacturing to support the commercialization of the Oncotelic’s assets as well as building out a pipeline of fast to market portfolio of drugs
The Company will provide its oncology/infectious disease pipeline
The IPO will be set up on the Hong Kong or other stock exchange.
The valuation of the IPO could be in the range of $1-2 Billion based on other comparables i.e. Genor Biopharma (HKEX: 6998), Pliant Therapeutics (Nasdaq:PLRX) and ScholarRock (Nasdaq:SRRK)
Assuming the valuation above is achieved, and with the proposed 35% ownership of the JV by the Company this could potentially translate into $350-700M in asset for the Company.
All this would be achieved without any dilution to the Company shareholders.
The proposed terms are being finalized as part of the definitive agreement within the next 45 days for shareholder approval.
This is the most transformative transaction for the company since its inception. We strongly recommend approval.
There is a standstill agreement in place for 45 days wherein the Company has agreed not to continue discussion of other competing transactions.
In consideration of standing still, GMP shall infuse $1.5 Million into the Company to support C001 clinical trial evaluating OT-101 against COVID-19
$OTLC .14 Huge IPO >> ONCOTELIC AND GOLDEN MOUNTAIN PARTNERS FORMING A JOINT VENTURE FOR IPO
Press Release | 08/16/2021
AGOURA HILLS, Calif., Aug. 16, 2021 (GLOBE NEWSWIRE) -- Oncotelic Therapeutics, Inc. ("Oncotelic" or the "Company") (OTCQB:OTLC), a leading developer of TGF-ß therapeutics for oncology and COVID-19 and Golden Mountain Partners, (“GMP”) announced that they are forming a joint venture (“JV”) to advance clinical development of Oncotelic’s pharmaceutical pipeline and build out of manufacturing facilities for the commercial launch of Oncotelic’s drug candidates. The JV is expected to be taken to an initial public offering (“IPO”). Recent IPOs for TGF- ß assets include Genor Biopharma, Pliant Therapeutics and ScholarRock. The Company and GMP signed a term-sheet, which amongst other requirements, includes moving into a standstill agreement and an immediate infusion of $1.5 Million by GMP into Oncotelic.
"This latest development is a continuation of our relationship with GMP, which started early 2020 when GMP began invested in Oncotelic COVID-19 programs. Being fully capitalized we look forward to rapid progress in bringing needed therapies to patients in both oncology and COVID-19. A robust IPO comparable to similar IPOs would be a strong win for Oncotelic’s shareholders who have been unwavering in their support for finding the cures for these debilitating diseases." said Dr. Vuong Trieu, CEO and Chairman of Oncotelic.
About Oncotelic Therapeutics
Oncotelic Therapeutics, Inc. (f/k/a Mateon Therapeutics, Inc.) ("Oncotelic"), was formed in the State of New York in 1988 as OXiGENE, Inc., was reincorporated in the State of Delaware in 1992, and changed its name to Mateon Therapeutics, Inc. in 2016, and Oncotelic Therapeutics, Inc. in November 2020.
Oncotelic is artificial intelligence driven immuno-oncology company with a robust pipeline of first in class TGF-ß immunotherapies for late stage cancers such as gliomas, pancreatic cancer and melanoma. OT-101, the lead immuno-oncology drug candidate of Oncotelic, is a first-in-class anti-TGF-ß RNA therapeutic that exhibited single agent activity in relapsed/refractory cancer patients. OT-101 also has shown activity against SARS-CoV-2 and has completed a phase 2 trial against COVID-19 with data cleaning and datalock ongoing. Oncotelic is seeking to leverage its deep expertise in oncology drug development to improve treatment outcomes and survival of cancer patients with a special emphasis on rare pediatric cancers. Oncotelic also has rare pediatric designation for DIPG (OT-101), melanoma (CA4P), and AML (OXi 4503). The Company also acquired PointR Data Inc. ("PointR") in November 2019. The PointR Acquisition was intended to create a publicly traded
For more information, please visit www.oncotelic.com and www.mateon.com.
$OTLC .14 Huge IPO >> ONCOTELIC AND GOLDEN MOUNTAIN PARTNERS FORMING A JOINT VENTURE FOR IPO
Press Release | 08/16/2021
AGOURA HILLS, Calif., Aug. 16, 2021 (GLOBE NEWSWIRE) -- Oncotelic Therapeutics, Inc. ("Oncotelic" or the "Company") (OTCQB:OTLC), a leading developer of TGF-ß therapeutics for oncology and COVID-19 and Golden Mountain Partners, (“GMP”) announced that they are forming a joint venture (“JV”) to advance clinical development of Oncotelic’s pharmaceutical pipeline and build out of manufacturing facilities for the commercial launch of Oncotelic’s drug candidates. The JV is expected to be taken to an initial public offering (“IPO”). Recent IPOs for TGF- ß assets include Genor Biopharma, Pliant Therapeutics and ScholarRock. The Company and GMP signed a term-sheet, which amongst other requirements, includes moving into a standstill agreement and an immediate infusion of $1.5 Million by GMP into Oncotelic.
"This latest development is a continuation of our relationship with GMP, which started early 2020 when GMP began invested in Oncotelic COVID-19 programs. Being fully capitalized we look forward to rapid progress in bringing needed therapies to patients in both oncology and COVID-19. A robust IPO comparable to similar IPOs would be a strong win for Oncotelic’s shareholders who have been unwavering in their support for finding the cures for these debilitating diseases." said Dr. Vuong Trieu, CEO and Chairman of Oncotelic.
About Oncotelic Therapeutics
Oncotelic Therapeutics, Inc. (f/k/a Mateon Therapeutics, Inc.) ("Oncotelic"), was formed in the State of New York in 1988 as OXiGENE, Inc., was reincorporated in the State of Delaware in 1992, and changed its name to Mateon Therapeutics, Inc. in 2016, and Oncotelic Therapeutics, Inc. in November 2020.
Oncotelic is artificial intelligence driven immuno-oncology company with a robust pipeline of first in class TGF-ß immunotherapies for late stage cancers such as gliomas, pancreatic cancer and melanoma. OT-101, the lead immuno-oncology drug candidate of Oncotelic, is a first-in-class anti-TGF-ß RNA therapeutic that exhibited single agent activity in relapsed/refractory cancer patients. OT-101 also has shown activity against SARS-CoV-2 and has completed a phase 2 trial against COVID-19 with data cleaning and datalock ongoing. Oncotelic is seeking to leverage its deep expertise in oncology drug development to improve treatment outcomes and survival of cancer patients with a special emphasis on rare pediatric cancers. Oncotelic also has rare pediatric designation for DIPG (OT-101), melanoma (CA4P), and AML (OXi 4503). The Company also acquired PointR Data Inc. ("PointR") in November 2019. The PointR Acquisition was intended to create a publicly traded
For more information, please visit www.oncotelic.com and www.mateon.com.
$OTLC .14 Last 1, HUGE 8K Multi Billion $$ IPO, $1.5M CASH INJECTED >>
https://www.otcmarkets.com/filing/html?id=15168688&guid=Jw49kqciy4e8Mth
$OTLC .14 Last 1, HUGE 8K Multi Billion $$ IPO, $1.5M CASH INJECTED >>
https://www.otcmarkets.com/filing/html?id=15168688&guid=Jw49kqciy4e8Mth
$OTLC .14 Falling IPO Valuation $2.60 - $5.20
$OTLC .14 Falling IPO Valuation $2.60 - $5.20