Theralase Technologies Inc (TLTFF)

[123414]

NUMBER OF COMMON SHARES OUTSTANDING
Share Price: C$0.14

Warrants: 72,473,931

Shares Outstanding: 204,275,375

Stock Options: 14,500,000

Fully Diluted: 291,249,306


This is not current but very close??

me tinks... Most of the warrants will be sold to V.TLT.W where they are sold in the open market.

https://theralase.com/stock-information/

[123414]

Study II Preliminary Results
As of November 29, 2021, Study II has enrolled and provided the primary study treatment for 30 patients (including three patients from the Study treated at the Therapeutic Dose) for a total of 33 patients, demonstrating the following interim results:

Note: Significant clinical data is still pending in Study II and drawing conclusions from this interim clinical data set and assumptions should be done with caution, as Study II is still ongoing and new clinical data collected may or may not continue to support the current trend.


*Includes three (3) patients treated at the Therapeutic Dose form Phase Ib NMIBC Clinical Study (2-CR and 1- NR at 90, 180, 270, 360, 450 days)

An analysis of the Study II clinical data (with 3 patients from Study Ib) provides the following interim assessments:

7/10 patients (70.0%), who achieved a CR at 90 days continue to demonstrate CR at 180 days
In the total population of 33 patients (@ 90 days):
42.4% achieved Complete Response (“CR”)
12.1% achieved Partial Response (“PR”)
21.2% are Pending
24.2% achieved No Response (“NR”)
Hence, the potential for CR is up to 75.8%** for the interim clinical data analysis.

Note**: Assumes both PR and Pending data are clinically determined to be CR at a later assessment date.

In the total population of 18 patients (@ 90 days), who received the optimized treatment:
44.4% achieved CR
11.1% achieved PR
38.9% are Pending
5.6% achieved NR
Hence, the potential for CR is up to 94.4%***

Note***: Assumes both PR and Pending data are clinically determined to be CR at a later assessment date for the interim clinical data analysis.

In summary, for patients who received the primary optimized Study II Treatment versus the original Study II Treatment (90 days), there is a 5% increase in CR and a 77% decrease in NR

Theralase Releases 3Q21 Financial Statements and Newsletter – Theralase Technologies

[123414]

The Analyst rated Theralase, then covid & under-treatments.


https://www.cantechletter.com/stock/tlt/

[123414]

My thoughts are that during the long period of decline for this stock- it was bought up mostly by longs. Where it is somewhat locked up.

Rodger alone has like 8 mill locked up...

Anyway... Once the stats beat merks people really did start to notice.

I think the cheap sellers are drying up...

[-3]

Is this retail in the US or funds that are buying or do you have an opinion ?

[123414]

$TLTFF Theralase performance

PERFORMANCE
5 Day
10.42%

1 Month
2.42%

3 Month
77.75%

YTD
93.50%

1 Year
93.50%

Last Updated: Dec 31, 2021 3:45 p.m. EST


TLTFF Stock Price | Theralase Technologies Inc. Stock Quote (U.S.: OTC) | MarketWatch

[-3]

Refresher " nothing short of miraculous " https://stockhouse.com/companies/bullboard/v.tlt/theralase-technologies-inc?postid=34223069

[123414]

Theralase Market potential $1.1 billion
243,308 new cases of bladder cancer each year in the U.S., Canada and Europe(1)

70%-168,000 are classified as NMIBC(2)
30%-50,400 become unresponsive to current standard of care treatment Bacillus Calmette-Gurin ( “BCGUnresponsive”) within 1 year(3)
Patients that fail BCG treatment are prescribed a radical cystectomy (5) (surgical removal of bladder and associated tissue)
Estimated: 80,470 new cases in US, and 11,838 new cases in Canada, 151,000 new cases of bladder cancer in Europe in 2019(1)

240,000(1) x 70%(2) x 30%(3) x ½ x $50,000(6) =

$1.1 billion

Patients in need, urgent demand for bladder cancer drug
Willingness to pay $50K - $150K(6)

Bladder cancer patients facing low quality of life after cystectomy From diagnosis to death, it will cost bladder cancer patients $89K-$200K(7) , as bladder cancer is the most expensive cancer to treat.

1) Key Statistics for Bladder Cancer – American Cancer Society (2018); Canadian Cancer Society (2019) and Bladder Cancer – European Cancer Patient Coalition
(2) https://www.uptodate.com/contents/bladder-cancer-treatment-non-muscle-invasive-superficial-cancer-beyond-the-basics#!
(3) The management of BCG failure in non-muscle-invasive bladder cancer: an update (2009)
(4) European Organization for Research and Treatment of Cancer (EORTC) - (Veeratterapillay R, Heer R, Johnson MI, Persad R, Bach C. High-risk non-muscle-invasive bladder cancer-therapy options during intravesical BCG Shortage. Curr Urol Rep. 2016;17:68) https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5769243/
(5) NCCN Guidelines Insights: Bladder Cancer, Version 5.2018, J Natl Compr Canc Netw 2018;16(9):1041–1053
(6) Willingness to pay per quality adjusted life year (QALY) for competitor drug, Pembrolizumab. Source: Cost-effectiveness of Pembrolizumab in Second-line Advanced Bladder Cancer, July 2018 (7) Sievert KD, Amend B, Nagele U, et al. Economic aspects of bladder cancer: what are the benefits and costs?. World J Urol. 2009;27(3):295–300. doi:10.1007/s00345-009-0395-z (8) 2025 estimated bladder cancer market (US, France, Germany, Italy, Spain, UK & Japan). Source: Global Data: Bladder cancer market size to more than triple to over $1.1 billion by 2025, April 2017


https://theralase.com/wp-content/uploads/2021/08/Corporate-PPT-09213.pdf

https://theralase.com/press-releases/

[MeghanStar]

Thanks 123414...

...all good tidings to you.

I appreciate your enthusiasm..

[123414]

Strong bullish indicators for Theralase.

PERFORMANCE

5 Day
10.65%

1 Month
53.53%

3 Month
49.46%

YTD
79.30%

1 Year
69.65%


CLOSED
Last Updated: Dec 27, 2021 3:20 p.m. EST
Delayed quote
$0.2650

0.0060 2.32%

[123414]

Potential Drive to .45 USD
Price calculated from trendline monthly chart Plots and company's latest phase 2 study CR rates:

Highs for August 2017
April 2019.

Expectation:

Market response similar to Monthly Chart period Nov 2016 through Aug 2017.



This current price level on the Ten-year Month,
is a historical point where sometimes the company sp really jumps up from these levels. Provided the company is making progress in their business plans. And they are.

if you consider the range the stock has held for so many years that is well above the current price point.

You might consider the market assessed the stock to be worth the SP at that time. And this was before they were approved for a Phase 2 study and before they had the data points that are unprecedented.

Before PHAC and St. Michaels.

So for me I see the value.

_________________________________________________

The hard and long fall from March 2019.

At the closing of the phase one study buyers were looking for the next business development and it was a long way out. The price fall began in March. Other investors soon realized how far out the next significant steps would be taken for Phase 2 Pivotal. And the market forces propelled.

The market forces are again propelling in the opposite.

______________________________________________________

TORONTO, ON / ACCESSWIRE / January 31, 2019 / Theralase Technologies Inc. ("Theralase®" or the "Company") (TSXV: TLT) (OTCQB: TLTFF), a clinical stage pharmaceutical company dedicated to the research and development of light activated Photo Dynamic Compounds ("PDCs") and their associated drug formulations intended to safely and effectively destroy various cancers reports that patient five, enrolled and treated in the recently completed Phase Ib Non-Muscle Invasive Bladder Cancer ("NMIBC") clinical study ("Study"), has demonstrated no tumour recurrence or presence of disease at the 360 day clinical and cystoscopy assessment.

The Study's purpose was to evaluate TLD-1433, Theralase's lead PDC, for the primary endpoint of safety and tolerability, secondary endpoint of pharmacokinetics (movement and exit of drug within tissue) and exploratory endpoint of efficacy, primarily at 90 days and secondarily at 180 days post treatment.

The Study was successfully completed with patient five and six demonstrating achievement of the primary, secondary and exploratory endpoints.

Patient five has demonstrated no tumour recurrence or presence of disease at the 90, 180, 270 and now 360 days post treatment clinical and cystoscopy assessment, marking a new achievement for the Company.

Patients five and six were enrolled and treated in the Study at the Therapeutic Dose (0.70 mg/cm2). Theralase's Anti-Cancer Treatment involved the intravesical instillation of a water-based solution of Theralase's lead anti-cancer PDC, TLD-1433, via a catheter inserted through the urethra into the bladder of the patient, to allow the PDC to be preferentially absorbed by NMIBC tumours. The bladder was then drained of the solution, flushed with sterile water to remove non-absorbed solution and refilled with sterile water via a cystoscope. A fibre optic assembly, comprising a Laser Emitter used to emit laser light and a proprietary Dosimetry System used to detect laser light, were then used to activate TLD-1433 resident in the NMIBC tumours.
------------------------------------------------

Monthly Chart Nov 2019 to present
Large down gaps, monthly chart 2019 July & August
Large up gaps, monthly chart 2021 Nov & Dec



2019 July Monthly High .3920 Low .2370
2019 August Monthly High .2609 Low .1636
2019 August Monthly gap filled - 2021 November
2021 November Monthly Low .1366 High . 2206

July 2019 Monthly Down gap fill in progress - Dec 2021.
2021 December Monthly Low .1950 High . 2989
Current .259

----------------------------------------------


https://theralase.com/theralase-releases-3q21-financial-statements-and-newsletter/

Study II Preliminary Results
As of November 29, 2021, Study II has enrolled and provided the primary study treatment for 30 patients (including three patients from the Study treated at the Therapeutic Dose) for a total of 33 patients, demonstrating the following interim results:

Note: Significant clinical data is still pending in Study II and drawing conclusions from this interim clinical data set and assumptions should be done with caution, as Study II is still ongoing and new clinical data collected may or may not continue to support the current trend.


*Includes three (3) patients treated at the Therapeutic Dose form Phase Ib NMIBC Clinical Study (2-CR and 1- NR at 90, 180, 270, 360, 450 days)

An analysis of the Study II clinical data (with 3 patients from Study Ib) provides the following interim assessments:

7/10 patients (70.0%), who achieved a CR at 90 days continue to demonstrate CR at 180 days
In the total population of 33 patients (@ 90 days):
42.4% achieved Complete Response (“CR”)
12.1% achieved Partial Response (“PR”)
21.2% are Pending
24.2% achieved No Response (“NR”)
Hence, the potential for CR is up to 75.8%** for the interim clinical data analysis.

Note**: Assumes both PR and Pending data are clinically determined to be CR at a later assessment date.

In the total population of 18 patients (@ 90 days), who received the optimized treatment:
44.4% achieved CR
11.1% achieved PR
38.9% are Pending
5.6% achieved NR
Hence, the potential for CR is up to 94.4%***

[123414]

On summary of Ph 2 data, 3Q newsletter

The data accrued to date for the TLD 1433-2 open label study for the treatment of NMIBC, seems very encouraging, and Theralase may as well be heading towards fulfilling the necessary outcome requirements to apply for a “BTD from the FDA very soon.

Dr. Vera Madzarevic Director Clinical Development & Quality Assurance, Theralase®

In accordance with the FDA’s 2018 guidelines to industry, the patients who have achieved a Partial Response (“PR”) are being further assessed via Computerized Tomography (“CT”) scan and/or biopsy of the prostatic urethra to determine if upper tract Urothelial Cell Carcinoma (“UCC”) or prostatic urethra UCC can be detected to allow these patients to be re-categorized as CR.

Effective October 25, 2021, Vera Madzarevic, Ph.D. assumed the role of Director of Clinical Development and Quality Assurance. Dr. Madzarevic holds a Ph.D. in both clinical pharmacology and biochemistry and brings over 25 years of global experience in clinical research and quality assurance in the biopharmaceutical and medical device industry to Theralase®.

https://theralase.com/wp-content/uploads/2021/11/3Q-2021-Newsletter.pdf

[123414]

As of November 29, 2021 Study II Preliminary Results
Study II Preliminary Results

As of November 29, 2021, Study II has enrolled and provided the primary study treatment for 30 patients (including three patients from the Study treated at the Therapeutic Dose) for a total of 33 patients, demonstrating the following interim results:

Note: Significant clinical data is still pending in Study II and drawing conclusions from this interim clinical data set and assumptions should be done with caution, as Study II is still ongoing and new clinical data collected may or may not continue to support the current trend.
Assessment Day*
90 Days 180 Days 270 Days 360 Days 450 Days
# % # % # % # % # %
Complete Response (“CR”) 14 42 % 7 21 % 7 21 % 4 12 % 4 12 %
Partial Response (“PR”) 4 12 % 5 15 % 2 6 % 4 12 % 2 6 %
Pending 7 21 % 13 39 % 15 45 % 16 48 % 17 52 %
No Response (“NR”) 8 24 % 8 24 % 9 27 % 9 27 % 10 30 %
Total Treated* 33 100 % 33 100 % 33 100 % 33 100 % 33 100 %
*Includes three (3) patients treated at the Therapeutic Dose form Phase Ib NMIBC Clinical Study (2-CR and 1- NR at 90, 180, 270, 360, 450 days)

An analysis of the Study II clinical data (with 3 patients from Study Ib) provides the following interim assessments:

1) 7/10 patients (70.0%), who achieved a CR at 90 days continue to demonstrate CR at 180 days

2) In the total population of 33 patients (@ 90 days):

i) 42.4% achieved Complete Response (“CR”)
ii) 12.1% achieved Partial Response (“PR”)
iii) 21.2% are Pending
iv) 24.2% achieved No Response (“NR”)

Hence, the potential for CR is up to 75.8%** for the interim clinical data analysis.

Note**: Assumes both PR and Pending data are clinically determined to be CR at a later assessment date.

3) In the total population of 18 patients (@ 90 days), who received the optimized treatment:

i) 44.4% achieved CR
ii) 11.1% achieved PR
iii) 38.9% are Pending
iv) 5.6% achieved NR

Hence, the potential for CR is up to 94.4%***

Note***: Assumes both PR and Pending data are clinically determined to be CR at a later assessment date for the interim clinical data analysis.

In summary, for patients who received the primary optimized Study II Treatment versus the original Study II Treatment (90 days), there is a 5% increase in CR and a 77% decrease in NR.

[noblynx]

$20.22 in 2022!

Thanks for these helpful posts, 123414. The science and the progress, here, are getting more and more exciting. And management - with the recent hiring of Dr. Madzarevic - seem to actually be getting their sh$^ together. Next four to five months hold a great deal of promise. I'm glad to have bumped up our holdings before this recent recovery - and the next "leg up" could be huge.

[123414]

Theralase - Research for Development of Coronavirus Vaccine

Theralase Commences Collaborative Research with National Microbiology Laboratory for Development of Coronavirus Vaccine

April 9, 2021 / Theralase® Technologies Inc. ("Theralase" or the "Company") (TSXV:TLT)(OTCQB:TLTFF), a clinical stage pharmaceutical company focused on the research and development of light activated Photo Dynamic Compounds ("PDC") and their associated drug formulations to safely and effectively destroy various cancers, bacteria and viruses, announced today that it has executed a Collaborative Research Agreement ("CRA") with the National Microbiology Laboratory, Public Health Agency of Canada ("PHAC") for the research and development of a Canadian-based SARS-CoV-2 ("COVID-19") vaccine.

Under the terms of the agreement, Theralase® and PHAC are collaborating on the development and optimization of a COVID-19 vaccine by treating the SARS-CoV-2 virus grown on cell lines with Theralase®'s patented PDC and then light activating it with Theralase®'s proprietary TLC-3000A light technology to inactivate the virus and create the fundamental building blocks of a COVID-19 vaccine. This inactivated virus would then be purified and used to inoculate naive animals followed by challenge with the SARS-CoV-2 virus, to ascertain the efficacy of the vaccine. The project is entitled, "Photo Dynamic Compound Inactivation of SARS-CoV-2 Vaccine" and is expected to commence in mid-April 2021.

PHAC is a world leader in vaccine creation and has a long history of vaccine development. PHAC scientists developed the world's first approved Ebola vaccine (Ervebo), which the Government of Canada donated to the World Health Organization ("WHO") during the height of the 2014-16 Ebola outbreak and in the process helped to save countless lives in Africa.

Darwyn Kobasa, Ph.D., Head, High Containment Respiratory Virus Group, Special Pathogens, PHAC/NML, stated "Our research expertise will help assist Theralase® to research and develop an effective COVID-19 vaccine that is robust enough to vaccinate against the main phenotype of the disease and its emerging variants. NML has unique capacity to conduct preclinical research in animal models, that must occur in high containment laboratory space, which is essential to the development of an effective COVID-19 vaccine. I am delighted for having the opportunity of testing the Theralase® anti-viral platform technology at PHAC. The in-vitro data I have reviewed demonstrates that Theralase®'s PDCs have a very high log kill of various Biological Safety Laboratory ("BSL")-2 viruses at nanomolar concentrations. The focus of our CRA is to demonstrate these same results using the SARS-CoV-2 virus, which is a BSL-3 virus. The tested efficacy in BSL-2 virus destruction, reported by Dr. Kevin Coombs of the University of Manitoba, shows that the Theralase® PDC is comparable to, or better than, many other anti-virals that my lab has tested. I look forward to working with Dr. Arkady Mandel and the Theralase® team in the development of this exciting technology."

Dr. Kevin Coombs, Ph.D., Professor, Department of Medical Microbiology at University Manitoba, stated, "I am delighted to see that Theralase®'s and my initial in-vitro research into BSL-2 virus inactivation has successfully advanced to the next stage of evaluation against BSL-3 viruses and if proven successful, on to preclinical vaccine manufacture and vaccination of animals against the SARS-CoV-2 virus in a challenge model at PHAC."

Dr. Arkady Mandel, M.D., Ph.D., D.Sc., Chief Scientific Officer, Theralase® stated, "In line with ongoing global efforts to combat the pandemic, the Company continues to move forward with the development of a safe and effective vaccine to inoculate individuals against COVID-19 and its variants. This new CRA enables Theralase the ability to collaborate with esteemed scientists at PHAC, who have the same mandate of developing new and improved vaccines for COVID-19 and its variants. This research and development will provide new opportunities for the Company; specifically, in the development of new anti-viral vaccination solutions, contributing to our growing platform of PDC-based technology applications. If proven successful, the Theralase® COVID-19 vaccine will support our healthcare professionals in safely and effectively combatting any new viral outbreaks, such as the one recently witnessed, with the global spread of COVID-19".

The Company does not claim or profess that they have the ability to treat, cure or prevent the contraction of the COVID-19 coronavirus.

Theralase Commences Collaborative Research with National Microbiology Laboratory for Development of Coronavirus Vaccine (accesswire.com)

[123414]

Theralase COVID-19 Vaccine Research
In April 2021, Theralase® executed a Collaborative Research Agreement (“CRA”) with the National Microbiology Laboratory, Public Health Agency of Canada (“PHAC”) for the research and development of a Canadian-based SARS-CoV-2 (“COVID19”) vaccine. Under the terms of the agreement, Theralase® and PHAC are collaborating on the development and optimization of a COVID-19 vaccine. The project is entitled, “Photo Dynamic Compound Inactivation of SARS-CoV-2 Vaccine” and commenced in mid-April 2021. This research and development is currently ongoing and no reportable data is available at this time.

3Q2021 | NOVEMBER 2021

[123414]

Just another chatty trendline plot.
Weekly chart.

10/21/19 .1861

05/18/20 .2221

02/22/21 .2550

12/06/21 .2989

[123414]

Last Updated: Dec 17, 2021 3:21 p.m. EST
TLTFF PERFORMANCE
5 Day
-12.78%

1 Month
23.58%

3 Month
53.04%

YTD
62.04%

1 Year
62.86%

[123414]

If the stock maintains some stability around this price till the next news release and the data is good. I think we well see another level up from our previous recent highs.

Cheers

[123414]

activation of Rutherrin® by radiation ( X-ray).

Rutherrin® activated by NIR light has been proven to destroy NSCLC tumours in subcutaneous and orthotopic model in mice. The Company is planning to advance the treatment of NSCLC by utilizing activation of Rutherrin® by radiation ( X-ray)

Non-Small Cell Lung Cancer (“NSCLC”) TLD-1433 + NIR Light = destruction of human NSCLC Cancer cells.

Corporate presentation

[123414]

$TLTFF Theralase launches Anti-Cancer Therapy Research Centre

Toronto, Ontario – March 29, 2021, ThERALASE (OTCQB: TLTFF), a clinical stage pharmaceutical company focused on the research and development of light activated Photo Dynamic Compounds (“PDC”) and their associated drug formulations used to safely and effectively destroy various cancers, bacteria and viruses announced today the launch of the Theralase® Anti-Cancer Therapy (“ACT”) research centre located within the Li Ka Shing Knowledge Institute of St. Michael’s Hospital, Unity Health Toronto, effective April 1, 2022, relocating its research team from University Health Network (“UHN”), Toronto.
The Li Ka Shing Knowledge Institute of St. Michael’s is home to leading researchers, educators and clinicians — dedicated professionals making new scientific discoveries, generating novel therapies, developing innovative training programs and helping translate knowledge into practice.

The ACT research centre is a fully equipped laboratory dedicated exclusively to Theralase® ACT research and development as it advances towards commercialization with its lead PDC, TLD-1433, as well as its systemic and targeted formulation – Rutherrin®. A Partnership with the Li Ka Shing Knowledge Institute of Unity Health provides access to additional expertise, advisory networks and opportunities to accelerate product development and commercialization.

Dr. Ori Rotstein MD, Msc., Vice President of Research and Innovation at Unity Health, Professor and Associate Chair of the Department of Surgery at University of Toronto welcomed Theralase® stating, “Our research facilities uniquely align scientific, clinical and business initiatives, which helps to accelerate our partners’ path to market by validating their solutions directly in the healthcare setting starting at the research bench and culminating to clinical studies.”

Michael Jewett MD, FRCSC, FACS, CM, Departments of Surgery (Urology), University of Toronto and Chair, Theralase Medical and Scientific Advisory Board, stated “I am delighted by the research and clinical milestones that the Theralase® team has been able to achieve in advancing its PDC technology, including, launching a Phase II Non-Muscle Invasive Bladder Cancer (“NMIBC”) pivotal clinical study in Canada and the US. In 2021, Theralase® plans to complete the non-Good Laboratory Practice (“GLP”) and GLP toxicology of Rutherrin® (TLD-1433 combined with transferrin) to be used as a radiosensitizer in the treatment of multiple solid tumor types: including Glio-Blastoma Muliforme (“GBM”) and Non-Small Cell Lung Cancer (“NSCLC”) among others. As Theralase® advances in its research with Rutherrin® it makes sense for the Company to launch its own independent research centre focused on this evolving technology.”

Lothar Lilge Ph.D., Senior Scientist Princess Margaret Cancer Centre, UHN, stated “I am pleased that Theralase® has graduated to its own independent research center. I will continue to support the Company in the research of light activated PDC therapy and Monte Carlo simulation.”

Arkady Mandel, M.D., Ph.D., D.Sc., Chief Scientific Officer, Theralase® stated that, “Launching the Theralase® ACT Research Centre at Unity Health aids in the translation of our cutting-edge scientific and pre-clinical research. Given the outstanding range of bactericidal, viral and cancer cell kill rates the Company has achieved to date, it has become clear there are opportunities abounding to expand our scientific horizons through collaborative arrangements in many diverse and exciting new clinical applications. The current pandemic of COVID-19 occurring world-wide reminds us how vulnerable we are to new infectious diseases and why new advanced and innovative technologies that combat such infectious agents are seriously needed. The Theralase® TLD-1433 and Rutherrin® technologies and patented medical laser systems are just such an innovation in the battle against cancer and infections, which claim countless lives every day world-wide. The Company now has an exceptional platform to continue an expanded laboratory research program as it actively advances the pivotal Phase II NMIBC clinical study to enroll and treat patients inflicted with Bacillus Calmette Guerin (“BCG“)-Unresponsive Carcinoma In-Situ (“CIS“) or who are intolerant to BCG Therapy (“Study II“) and prepares for Good Laboratory Practices (“GLP”) toxicology testing of Rutherrin ® in 4Q21.”

[123414]

On summary of Ph 2 data, 3Q newsletter

The data accrued to date for the TLD 1433-2 open label study for the treatment of NMIBC, seems very encouraging, and Theralase may as well be heading towards fulfilling the necessary outcome requirements to apply for a “BTD from the FDA very soon.

Dr. Vera Madzarevic Director Clinical Development & Quality Assurance, Theralase®

In accordance with the FDA’s 2018 guidelines to industry, the patients who have achieved a Partial Response (“PR”) are being further assessed via Computerized Tomography (“CT”) scan and/or biopsy of the prostatic urethra to determine if upper tract Urothelial Cell Carcinoma (“UCC”) or prostatic urethra UCC can be detected to allow these patients to be re-categorized as CR.

Effective October 25, 2021, Vera Madzarevic, Ph.D. assumed the role of Director of Clinical Development and Quality Assurance. Dr. Madzarevic holds a Ph.D. in both clinical pharmacology and biochemistry and brings over 25 years of global experience in clinical research and quality assurance in the biopharmaceutical and medical device industry to Theralase®.

https://theralase.com/wp-content/uploads/2021/11/3Q-2021-Newsletter.pdf

[123414]

TLTFF Dropped out of its 10-year range due to Covid and an initial Phase 2 Protocall that was corrected after the first 12 patients. The first 12 treated patients from the phase 2 study were very substantially undertreated, in both 1433 instill volume and bladder volume calculations. That had to be corrected after the first "dirty dozen" were treated. The company corrected the issue, and we are now seeing the good data just start to come in. That is why we are entering back into the 10-year range.

The patients from the phase 1 study only received one treatment. In this phase 2 PIVITOL study the patients will receive 2 treatments. The second treatment any dirty dozen patients get would have been or will be at the highly effective dose. (2nd treatment is scheduled 6 months from first treatment.)

The initial assessment of the Phase 1 study was so good it was halted early for the starting of the Phase 2 study.

Covid delays also like the whole broader markets affected this stock. But they have been treating patients and are in progress with Data for Breakthrough Thearapy Designation. BTD Theralase was especially hit hard by the covid circumstance.

We are back in the low side of the range with more significant developments than ever before in the stocks history.

If this stock shows stability at around .32 CAD (.25 cents USD) till the next release and the data is good again I think the probability of getting to the high range or a breakout is probable.

Selling Cheap is silly....

The science is solid.


Cheers,
123414

Long TLTFF since 2014

[123414]

Let's talk Dec 2nd buying. TLTFF action consisted of 626,028 shares sold that day with 408,197 shorted. Dec 2nd opened at .2066 and closed at .2592. I think the principal buying came from let's say Data aware private investors, who expect in the near term the stock price will rise. So they wanted to get them shares.

Let's talk Dec 3. TLTFF action consisted of 1,038,430 shares sold that day with 594,900 shorted. Dec 3rd opened at .27 and closed at .2793. I think both days saw them strip out TLTFF stock from brokers and brokers had to refill. I think also Data aware private investors were looking to maybe burn hostile shorts.

Theralase has many irons in the fire. They are heads down getting the work done. I do think the bargains on this stock are over. I enjoyed some good buying with the covid delay. And some more good buying on the somewhat bumpy start. I bought some this week and will continue to buy. Theralase is working towards a covid vaccine since April. The Canadian government is all up in there with them because they see the data.

We are moving solidly towards a very cold flu season.

-------------------------------------------------

In April 2021, Theralase executed a Collaborative Research Agreement with the National Microbiology Laboratory, Public Health Agency of Canada for the research and development of a Canadian-based SARS-CoV-2 vaccine. Under the terms of the agreement, Theralase and PHAC are collaborating on the development and optimization of a COVID-19 vaccine. The project is entitled, Dynamic Compound Inactivation of SARS-CoV-2 Vaccine and commenced in mid-April 2021. This research and development is currently ongoing and no reportable data is available at this time.

https://theralase.com/wp-content/uploads/2021/11/3Q-2021-Newsletter.pdf

[123414]

Sept 2021 Corporate presentation.
Shares Outstanding 204,275,875
Warrants 72,473,431
Options 13,370,000

Analyst Coverage Mackie Research Capital Echelon Wealth Partners Target Price “$0.80” by Mackie Research “$0.50” by Echelon Wealth

FULLY FUNDED The Company successfully completed an oversubscribed marketed public offering on August 22, 2019, raising gross proceeds of CAD $17,250,000, fully funded for Phase II NMIBC Clinical Study.

TREATMENT FOR VARIOUS CANCERS Planning on initiating Phase 1b study for other cancer indications. Strong upside for growth and valuation.


PowerPoint Presentation (theralase.com)

[noblynx]

CHECK THIS OUT. (Thanks to @lonade who quoted this on the ceo.ca message board, from Enrique)


"One of the few good posts from Stockhouse: Great series of posts from Enrique - an absolute "must read" for anyone invested in Theralase or considering investing in Theralase. The results revealed in the newsletter are astonishing. Ultimately it is only the results of the optimized treatment patients that matter because from patient 13 on, every patient will receive the optimized treatment and it is these patients whose results genuinely reflect the efficacy of the treatment. My summary:

Of the first 20 optimally treated patients:

10 are CR
7 were treated less than 90 days ago
2 are PR - have no cancer in their bladders but tested positive for cancer in their urine
1 patient was NR who died of unrelated causes before 90 days, but tested negative for cancer in urine

10 out of 20 patients = 50% CR
If all 7 are CR at 90 days = 85% CR
If the 2 PR patients end up classified CR, CR = 95% CR
If you include (or exclude) the patient who died because he appeared to be CR before 90 days CR = 100%

And the kicker is that none of these patients have received the 180-day treatment yet. So if the negative urine cytology in the 2 PR patients is caused by some remaining cancer cells in the bladder and not by cancer in the ureters, they have another kick at the can at 180 days."

[noblynx]

Yes it is!

https://theralase.com/wp-content/uploads/2021/11/3Q-2021-Newsletter.pdf

Potential total of Complete Responses in phase II trials is way up there. Maybe today a nice POP! (As the beginning...)

[BIGKAHUNA57]

Quarterly Report is available.

It's good news.

Good luck to all. Regards,BK

[Gene_Simmons]

Is it report time tomorrow?

[noblynx]

Press release: "Theralase Announces Leadership Reorganization"

Again. Appears to have been quite the botch job, hiring Trikola. How frickin' embarrassing.

On the other hand, new hire, Dr. Vera Madzarevic, has seriously good creds - right up the clinical-trials alley we need to keep heading down. And the emphasis on the future of the company in THIS p.r. is an emphasis on the Anti-Cancer Therapy, thank goodness, in sharp contrast with what came through in the p.r. about the last leadership change.

Maybe they're getting their ACT together for real, now?! Quarterly report, end of this month (?) should be interesting, to say the least.

[123414]

$TLTFFOn the preliminary results, Theralase said,

“The current interim analysis of the clinical data (with significant clinical data still pending and based on only 27 patients) demonstrates that Study II’s primary (33.3 per cent) and tertiary objectives (1 Severe AE) demonstrate a strong initial efficacy, strong durable efficacy and a high safety profile. There is insufficient data to comment on the Study II secondary objective,” the company stated in the August 30 press release.

Commenting on the quarter and preliminary results, Uddin said with the TLD-1433 still in Phase 2, financials are less important for TLT at the moment.

On the Phase 2 study, Uddin said, “TLT reported an interim analysis across a treatment period of 450 days based on the 24 subjects and three subjects from the previous Phase 1b trial treated at the therapeutic dose. At 90 days of treatment, 33.3 per cent of the 27 subjects (nine) achieved CR, which decreased to 18.5 per cent (5) at 270 days and 11.1 per cent (3) at 360 days. We believe what is most important with this preliminary dataset is that at 270 & 360 days, there were 37.0 per cent (10) and 40.7 per cent (11) of the 27 subjects which had not received both doses of TLD-1433.”

On the comparison with Merck’s Keytruda, which has been approved for BCG-unresponsive NMIBC and has achieved a 19 per cent complete response at 12 months of treatment in the pivotal KEYNOTE-057 study, Uddin wrote,

“For the 27 subjects in TLT’s pivotal trial to achieve the same CR rate at 360 days as Keytruda, an additional three subjects out of the 11 which had not received both doses of TLD-1433 would need to achieve CR – representing a 27 per cent threshold (3/11) – we believe this is a feasible threshold for Theralase given the data presented to date,” Uddin said.

“As the Phase 2 pivotal trial continues to progress, we believe the results should elucidate the efficacy potential of TLT-1433. We are maintaining our SPECULATIVE BUY rating and a target price of $0.70,” Uddin wrote.

https://www.cantechletter.com/2021/09/theralase-technologies-has-a-233-per-cent-upside-says-research-capital/#

[123414]

$TLTFF-25 patients for potential Breakthrough Designation Approval-2021

Shawn Shirazi PhD, Chief Executive Officer, Theralase®, stated, "Another milestone has been reached by the Company with the addition of MU in Pennsylvania as a clinical study site. Theralase is focused on its target of enrolling and treating 11 additional patients in early 2021 for a total of 25 patients for potential Breakthrough Designation Approval and approximately 100 patients in 2021 / 2022."

https://www.accesswire.com/625524/Theralase-Launches-Third-Clinical-Study-Site-in-the-US-for-Phase-II-Bladder-Cancer-Clinical-Study
January 25, 2021

[123414]

$TLTFF- In good standing to challenge Merck’s Keytruda.

Research Capital analyst André Uddin is sticking with his “Speculative Buy” rating on drug and device developer Theralase Technologies (Theralase Technologies Stock Quote, Charts, News, Analysts, Financials TSXV:TLT) after the company’s latest earnings report. In an update to clients on Tuesday, Uddin said time will tell how Theralase’s lead photodynamic compound, TLD-1433, compares with Merck’s immunotherapy Keytruda.

Toronto-based Theralase has a legacy business in marketing cool laser therapy devices for pain and inflammation management and is currently focused on developing its photodynamic therapy for treating BCG-unresponsive non-muscle invasive bladder cancer (NMIBC).

The company released its second quarter financials on Tuesday, showing total revenue up 47 per cent year-over-year to $430,000 with a net loss of $2.1 million compared to a loss of $3.3 million a year ago. Theralase ended the quarter with $5.9 million in cash and zero debt.

Theralase attributed the top-line gain to the impact of COVID-19 last year where healthcare practitioners had closed offices and put orders for the company’s cool laser devices on temporary or permanent hold. The lower net loss was chalked up to a delay in patient enrolment and treatment for its Phase 2 NMIBC clinical study due to COVID 19 along with decreased salaries due to COVID-19, resulting in the loss (resignation or termination) of administrative, research and production personnel).

Theralase had a leadership shake-up recently with the departure of CEO Shawn Shirazi on August 20, with John Trikola, recent president of Gardner Ross Corp., taking on the positions of COO and Interim CEO.

“I am honored to join Theralase as the COO and Interim CEO. I have developed a deep appreciation for what makes Theralase so special and I believe the Company has tremendous opportunities in front of it to capitalize on the innovation and technological advancements that the Company has demonstrated to date. I look forward to working with all stakeholders to enhance the buyer experience and provide additional capabilities that will help health care practitioners sustain and grow their businesses. I will focus on continuing to evolve the Company’s strategy while delivering on Theralase’s commitment to maximizing long-term shareholder value,” said Trikola in an August 19 press release.

On the NMIBC study, Theralase said it has five clinical study sites now launched in Canada and seven in the United States for patient enrolment and treatment, for a total of 12 sites. So far, the study has provided primary study treatment for 24 patients including three from the Phase 1b study treated at the Therapeutic Dose for a total of 27.

On the preliminary results, Theralase said,

“The current interim analysis of the clinical data (with significant clinical data still pending and based on only 27 patients) demonstrates that Study II’s primary (33.3 per cent) and tertiary objectives (1 Severe AE) demonstrate a strong initial efficacy, strong durable efficacy and a high safety profile. There is insufficient data to comment on the Study II secondary objective,” the company stated in the August 30 press release.

Commenting on the quarter and preliminary results, Uddin said with the TLD-1433 still in Phase 2, financials are less important for TLT at the moment.

On the Phase 2 study, Uddin said, “TLT reported an interim analysis across a treatment period of 450 days based on the 24 subjects and three subjects from the previous Phase 1b trial treated at the therapeutic dose. At 90 days of treatment, 33.3 per cent of the 27 subjects (nine) achieved CR, which decreased to 18.5 per cent (5) at 270 days and 11.1 per cent (3) at 360 days. We believe what is most important with this preliminary dataset is that at 270 & 360 days, there were 37.0 per cent (10) and 40.7 per cent (11) of the 27 subjects which had not received both doses of TLD-1433.”

On the comparison with Merck’s Keytruda, which has been approved for BCG-unresponsive NMIBC and has achieved a 19 per cent complete response at 12 months of treatment in the pivotal KEYNOTE-057 study, Uddin wrote,

“For the 27 subjects in TLT’s pivotal trial to achieve the same CR rate at 360 days as Keytruda, an additional three subjects out of the 11 which had not received both doses of TLD-1433 would need to achieve CR – representing a 27 per cent threshold (3/11) – we believe this is a feasible threshold for Theralase given the data presented to date,” Uddin said.

“As the Phase 2 pivotal trial continues to progress, we believe the results should elucidate the efficacy potential of TLT-1433. We are maintaining our SPECULATIVE BUY rating and a target price of $0.70,” Uddin wrote.



Uddin also commented on a recent event from competitor Sesen Bio, which on August 13 received a complete response letter (CRL) from the US FDA on a BLA for its Vicineum in BCG- unresponse NMIBC. Uddin related that Sesen aims to meet with the FDA in the fourth quarter of this year to get better clarity on next steps. The analyst said the announcement could open a potential window of opportunity for TLT, saying,

“On August 18th, a report by STAT News, which was based on SESN’s internal documents obtained by STAT, stated SESN’s pivotal trial with Vicineum had thousands of violations of study rules, investigator misconduct and worrying signs of toxicity SESN did not publicly disclose,” Uddin wrote.

At press time, Uddin’s $0.70 target represented a projected one-year return of 233 per cent.

https://www.cantechletter.com/2021/09/theralase-technologies-has-a-233-per-cent-upside-says-research-capital/#

[suerte88]

Comon, go big haha

[noblynx]

Have dry powder? Time to load up...

[noblynx]

My gosh - what a presentation! They're finally actually communicating well about what they (and we stockholders) have going with this incredibly promising technology.

[BIGKAHUNA57]

Corp Presentation Update

https://theralase.com/wp-content/uploads/2021/08/Corporate-PPT-09213.pdf

Good luck to all. Regards,BK

[BIGKAHUNA57]

I was way off about MC. Revised

The number of outstanding shares is 204.28M, so that would be approximately $4.89 per $B MC.

I'm thinking this is a $50-$100 stock, which puts at approx. +$10B-+$20B.

But, something else is telling me that investors want to be on the right side of an investment, and this is so far beyond Amazon, FB or Google.


These meds are messing me up.

Good luck to all. Regards,BK.

[BIGKAHUNA57]

This stock can be very frustrating. Has gone for long periods of time without much movement. But now there's science and proof of lab performance on patients, which this last quarterly confirmed.

This is highly speculative, but the prior lab/petre dish tests are getting proven on patients.

I wanted to inform everyone prior to the next quarterly report which should be late October from the Sept 30 EOQ period. If that report continues to provide patient data that extends the CR in patients that have been treated, and exhibits high CR performance on new patients that have 90 performance data - I don't know what affect that may have. It's all new information.

This is a cure for 1 type of cancer. It has practical applications for many other types that have gone through the same lab vetting process to check for efficacy. It's been reviewed for melanoma, brain cancer and Non-small cell lung cancer.

Someone asked what's the expected sp target? Every increment of $3.50 is approximately $1B in MC. What's a cure for cancer worth? And now Health Canada is testing in their Level4 Microbio Lab for Covid, SARS, and other viruses. What's that worth?

I can't tell how many people, or funds will pile in. I'm thinking this is a $50-$100 stock, which puts at approx. $14B-$28B. But, something else is telling me that investors want to be on the right side of an investment, and this is so far beyond Amazon, FB or Google.

Good luck to all. Regards,BK.

[ShortsRClowns]

Lots going on with this name, weird to see it at .19. Seems like there has been some promising data around its bladder cancer treatment that would warrant a better pps.

[BIGKAHUNA57]

They're also in Covid vaccine and therapeutic review and testing through the Public Health Agency Canada, National Microbiology Lab.

Good luck to all. Regards,BK.

[ShortsRClowns]

I realize they are only in late preclinical stage for Glioblastoma treatment but if this company can make any positive headway in combating this awful cancer it would be a blessing for so many families and hopefully they can avoid losing a love one to this hideous disease.

[ShortsRClowns]

I think an important call out, in bold below, is the following:

'NMIBC is an urgent and highly unmet medical need; therefore, Theralase® should not be required to conduct a Phase III clinical study, if successful, only Phase IV post-approval monitoring.'

[ShortsRClowns]

Thanks. This hits close to home what this company is trying to combat.

[BIGKAHUNA57]

The University of Chicago Medicine 7th Study Site

https://www.curetoday.com/view/phase-2-bcg-unresponsive-bladder-cancer-study-gets-the-ok-to-start-enrollment

Phase 2 BCG-Unresponsive Bladder Cancer Study Gets the OK to Start Enrollment
September 1, 2021
Jamie Cesanek

Patients with Bacillus Calmette Guérin-unresponsive carcinoma in-situ will be treated at the University of Chicago in a Theralase study.

The University of Chicago Medicine received approval from the Institutional Review Board to begin enrolling patients in a clinical trial from Theralase in June.

Researchers on the trial, which is the Phase 2 Non-Muscle Invasive Bladder Cancer Clinical Study, will enroll and treat 100-125 patients who were diagnosed with Bacillus Calmette Guérin (BCG)-unresponsive carcinoma in-situ. These patients must have also shown intolerance to BCG therapy.

“This technology harnesses the power of near infrared light produced by a laser to destroy localized bladder cancer cells that have not responded to standard of care therapy such as BCG. It gives patients an option to consider before bladder removal,” stated Dr. Piyush Agarwal, Professor of Surgery and Urology, Director of the Bladder Cancer Program and Fellowship Director of Urologic Oncology at the University of Chicago Medicine, in a release.

The first patient to be treated in the study received their treatment at Virginia Urology in Richmond, Virginia.

The study will be Theralase’s seventh U.S.-based clinical study site. The clinical stage pharmaceutical company will submit clinical assessment data on the first 25 patients who are treated in the study to the Food and Drug Administration (FDA) for consideration of breakthrough designation status. So far, 20 patients have been enrolled in the trial, plus three from the phase 1b study.

Good luck to all. Regards,BK

[BIGKAHUNA57]

Optimized dosage summary:

IMO> I don't think there needs to be any further discussion as to the summary of optimized dosage and subsequent effects of this study, to date.

Clipped from Stockhouse 08.31.21

https://stockhouse.com/companies/bullboard?symbol=v.tlt&postid=33788524

Right. So then Enrique

Of the optimized from day 1,ever:
8 Total
6 CR
1 NR
1 partial

That makes the 87.5% 90 day response that keeps coming up.

That is really good.

Good luck to all. Regards,BK.

[BIGKAHUNA57]

I agree. The vaccine and therapeutic would change everything.

Good luck to all. Regards,BK

[noblynx]

And the big news there could come much sooner.

[noblynx]

I'm here also for the COVID variants vaccine.

[BIGKAHUNA57]

I'm only here for the cancer cures. The laser is an activation device but not worth the long-term cash investment, unless we get revenue sharing % and shares of the pharma that buys the cancer division.

And it would be interesting to know what the pharma would consider fair-market value for the BO. The lawsuits would be many against the BOD, if the BO wasn't above $50/share considering the future application of all cancers that 1433 and Ru(II) can address. And any effects as a therapeutic. So many potential avenues for the good of mankind, and of course revenue. But, mainly for mankind.

JMO.

Good luck to all. Regards,BK.