TLX - Telix Pharmaceuticals

Telix Pharmaceuticals is an oncology company that operates in the radiopharmaceutical industry.

Telix’s Portfolio consists of an extensive pipeline of in-licensed, acquired and Company-originated IP that focuses on "targeted radiopharmaceuticals", also referred to as "molecularly-targeted radiation" (MTR).

The Company's Portfolio comprises a pipeline of clinical-stage products for kidney, prostate and brain cancer that the Company believes have the potential to signifcantly impact the diagnosis and treatment of cancer, if planned clinical trials are successful.

Telix was incorporated in January 2017 and is headquartered in Melbourne, Australia. Its technical team is spread across Australia, Germany, France and the United States.

It is anticipated that TLX will list on the ASX during November 2017.

http://www.telixpharma.com

This company was founded by the guy who used to run the Long Tail investment blog.

https://asxlongtail.com/

It hasn't been active for a while but was a pretty good blog from the science POV. Last I had heard he was running a stock research company, but it looks like he moved on to other things.

After listing in November 2017 at 65c a share, TLX sank to the mid-40's in February and March this year before finding its feet and for the last few months it has been range trading mostly between 65c and 70c.

This morning it announced that it has been granted certificates from the Department of Innovation, Industry and Science for an advance/overseas R&D tax finding totaling A$55.2 million.

From the announcement:

The certificates, issued under s28a and s28c under the Industry Research and Development Act 1986 (“IR&D Act”), pertain to highly specific works of pre-clinical, clinical, manufacturing and regulatory-related activity undertaken internationally by Telix in relation to its diagnostic and therapeutic oncology programs in kidney cancer (TLX250), prostate cancer (TLX591) and glioblastoma (TLX101). The certificates are issued to enable partial recovery of overseas R&D expenditure that are essential to Telix’s programs but cannot be executed domestically by Australian vendors and service providers.

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The announcement sent the share price up 6.35% to be currently trading at 67c. Biotechs are difficult companies to value or predict but I'm watching TLX for a break above 70c as I feel that improving sentiment may continue to support the share price in the short term.

Breakout for Telix Pharmaceuticals today as the share price broke though the 95c level on good volume.

greggles said:

Breakout for Telix Pharmaceuticals today as the share price broke though the 95c level on good volume.

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Good morning Greg
Are you still following this stock ?
Regards

Hi Miner, I have taken a quick look at it every now and again but its share price has been consolidating between 68c and 77c for the last couple of months and there hasn't been a lot to comment on.

However, since I last posted in this thread its share price collapsed from around $1 to a low of 57c but it quickly bounced back to 70c-75c.

Do you have any research or analysis to share on it?

greggles said:

Hi Miner, I have taken a quick look at it every now and again but its share price has been consolidating between 68c and 77c for the last couple of months and there hasn't been a lot to comment on.

However, since I last posted in this thread its share price collapsed from around $1 to a low of 57c but it quickly bounced back to 70c-75c.

Do you have any research or analysis to share on it?

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Hi @greggles
I was driven from the Kalkine recommendation today about penny biotech stock TLX. I digged the company details and was impressed on its research (claim) on cancer. Particularly their imaging technique as described on website could be a real breakthrough. Of course they have high risk .
https://www.asx.com.au/asxpdf/20190124/pdf/4421yp5sn4krb5.pdf (THIS ONE is highly promising)
https://www.asx.com.au/asxpdf/20190228/pdf/4432xkyf63ctty.pdf
They are not long timers on market however.
Cheers

TLX published its 6 monthly report aftermarket was closed.
https://www.asx.com.au/asxpdf/20190822/pdf/447rf3gdspv0pz.pdf
It just raised capital @$1.30 recently.
I am eager to see the market reaction on Friday considering the company's reduction on NAV, increased losses and reduced cash.
The company's products are of significant importance and this news of hiring an ex CSL is of interesting (please read the human capital section of the attachment).

Telix Pharmaceuticals Limited (TLX) is a clinical-stage biopharmaceutical company focused on the development of diagnostic and therapeutic products based on targeted radiopharmaceuticals or molecularly-targeted radiation. TLX is headquartered in Melbourne with international operations in Brussels, Kyoto and Indianapolis. TLX is developing a portfolio of clinical-stage oncology products that address significant unmet medical need in renal, prostate and brain (glioblastoma) cancer.

One of my picks for 2020

Iggy

My left palm is itching
https://www.asx.com.au/asxpdf/20200225/pdf/
[URL='https://www.asx.com.au/asxpdf/20200224/pdf/44fcv36jwh296d.pdf']https://www.asx.com.au/asxpdf/20200224/pdf/44fcv36jwh296d.pdf[/URL]

Oncology researcher Telix Pharmaceuticals says cost cutting saw it reduce its quarterly cash outflow to $6.9 million in the June quarter, versus $14.5 million in the prior quarter. It earned $2.1 million in revenue over the prior six month period. As at the period end it had cash on hand of $24.4 million with an additional $11.4 million in cash refunds received after the quarter end.

Telix chief executive, Dr. Chris Behrenbruch, stated:

“In line with the guidance we provided in April 10, COVID-19 has resulted in an expected reduction in prostate cancer imaging kit sales this quarter as many oncology and radiology services, including non-urgent surgeries were deferred to manage patient risk. Given the ongoing nature of the pandemic we expect that this trend will continue into the third quarter with fairly flat sales. While the revenue from these sales is not material to Telix’s cash runway, these sales do provide an important opportunity for early customer engagement and preparation ahead of commercial product launch."

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- but a need for cash in the short to medium term, I'd think

for an International fund one local company that the unlisted Platinum International Healthcare Fund ( total return of 25.7 per cent net of fees over t12 months to October) has researched and invested in is Telix

...Ogden says the health sector will remain a beneficiary of structural trends, including the wave of technological developments in diagnostics. Telix Pharmaceuticals is one the fund is backing....
"It's an interesting company because it's not a biotech that says, 'okay, we have one product and we've got to develop this'. The idea is that they will consolidate some of the radiotherapy industry and so they went out and acquired different assets. "And not just for, for a therapeutic side, but also to diagnose cancer or stage cancer, and we like that kind of multi-approach."

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Since inception, daily

Jump to new

An agreement with Scintec Diagnostics GmbH to acquire TheraPharm GmbH, a Swiss-German biotechnology company developing innovative diagnostic and therapeutic solutions in the field of hematology.

The acquisition of TheraPharm provides Telix with access to a portfolio of patents, technologies, production systems, clinical data and know-how in relation to the use of Molecularly Targeted Radiation in hematology and immunology. TheraPharm is developing antibody MTR technology against CD66, a cell surface target highly expressed by neutrophils (a type of granulocyte, a category of white blood cell) and tumor-infiltrating lymphocytes.

As such, the technology has potentially very broad applications in the diagnosis and treatment of hematologic diseases (e.g. blood cancers), infection management and a variety of lymphoproliferative diseases. Of particular interest is the demonstrated use of the technology to safely and effectively condition patients prior to bone marrow stem cell transplant.

Core competency

Upfront payment: EUR €10.2M (~AUD $16.5M) upfront payment comprising: 1) EUR €10.0M (~AUD $16.2M) in Telix ordinary shares based on the 10-day volume-weighted average price at the date of completion; and 2) EUR €0.2M (~AUD $0.3M) completion payment.
• First earn-out component: EUR €5.0M (~AUD $8.1M) cash payment upon successful completion of a phase III pivotal registration (approval) trial with 90Y-anti-CD66-MTR that meets the primary endpoint, for the first therapeutic indication only.
• Second earn-out component: EUR €5.0M (~AUD $8.1M) cash payment upon approval of 90Yanti-CD66-MTR in either United States or Europe, for the first therapeutic indication only.
• Third earn-out component: 5% royalty calculated on net sales for the first three years of sales of therapeutic products based on 90Y-anti-CD66-MTR from the date of first approval (US or EU).
• Escrow: As part of the Share Sale Agreement, Scintec will have its shareholding subject to escrow for 24 months from the completion date.

The TheraPharm technology has potentially broad application in the diagnosis and treatment of haematologic diseases such as blood cancers, infection management and a variety of immunodeficiency diseases.
TheraPharm already has a diagnostic imaging product approved in Europe and marketed as Scintimun targeting white blood cells, for the purpose of locating areas of infection in patients with suspected bone infection.

The deal provides Telix with access to a portfolio of patents, technologies, production systems, clinical data and know-how in in the use of molecularly targeted radiation in haematology and immunology. MTR drugs deliver targeted radiation to a patient. This is an injection, with a homing beacon attached to the radioactive drug. It finds the cancer cells and attaches itself and kills them. This allows it to selectively attack this area.

Telix plans to pursue its first non oncology indication in TheraPharm's drug candidate, 90Y-anti-CD66-MTR, which has demonstrated promising initial safety and efficacy data in systemic amyloid lightchain amyloidosis. SALA is a rare but serious protein deposition disease, caused by a protein known as an amyloid that is produced by abnormal plasma cells residing in the bone marrow. Protein deposition and formation of amyloids are associated with several neurodegenerative diseases.
There are about 30,000 and 45,000 people suffering from SALA in the United States and Europe respectively. It has a median survival rate from diagnosis of about 11 months if untreated.

Telix chief executive Christian Behrenbruch said the acquisition of TheraPharm and its MTR assets were uniquely aligned to Telix's mission and technical strengths in antibody engineering and radiochemistry.

"TheraPharm technology has a significant role to play in BMC [bone marrow conditioning] and stem cell transplantation across a broad range of blood cancers and rare diseases," Dr Behrenhruch said. "MTR offers an excellent safety profile that may greatly expand the number of patients able to undergo life prolonging stem cell transplantation while greatly reducing the hospitalisation burden and cost associated with such procedures. "The current approach to BMC employs highly toxic drugs that have a poor morbidity and mortality profile, and for which many patients are ineligible."

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Telix said the TheraPharm technology had potentially a very broad application in the diagnosis and treatment of haematologic diseases (like blood cancers), infection management and a variety of lymphoproliferative diseases. For example, B cell lymphoproliferative disorders are conditions in the blood involving uncontrolled growth of white blood cells, including cancers as multiple myeloma, Hodgkin lymphoma and chronic lymphocytic leukaemia.

Dr Behrenhruch said of particular interest was the demonstrated use of the technology to safely and effectively condition patients prior to bone marrow stem cell transplant.

- market liked it; alltime high around $3.50

Dona Ferentes said:

- market liked it; alltime high around $3.50

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and higher today after the Investor Call

• Extends Telix’s MTR capabilities into a major new application space
• Single asset opens new opportunities in hematologic oncology, HSCT transplant medicine and a variety of high-value rare diseases
• Diagnostic product EMA approved and revenue generating, with significant potential for expanded clinical indications
• Therapeutic product offers a potentially rapid path to market with strong clinical data and very broad EU orphan designation (with IP to back up)
• Significant market opportunity with many application areas, clear lead indication (with data out very soon)
• Plays to Telix’s development strengths and EU manufacturing infrastructure
• Excellent team and scientific advisory board to join Telix

closed at high 3.72

meaningful progress, meaningful study, meaning the full $4.00 achieved yesterday was ambitious but fair


Telix is able to confirm its intention to proceed with the Phase III ProstACT study as an international, multi-centre, randomised controlled trial comparing best standard of care with and without TLX591, in patients with PSMA-expressing metastatic castration-resistant prostate cancer, who have disease progression following prior treatment with a novel androgen axis drug.

The primary endpoint for the ProstACT study will be radiographic progression-free survival , with secondary outcome measures including overall survival, quality-of-life and safety. Based on the statistical plan presented to the FDA, the ProstACT study will enrol approximately 390 patients, based on a 2:1 randomisation and enrichment of the study population using 68Ga-PSMA imaging with TLX591-CDx to identify patients with PSMA-avid disease.

and more... buy on rumour, buy more on fact?

Australia’s healthcare regulator the Therapeutic Goods Administration (TGA) has approved Telix’s prostate cancer imaging product named Illuccix.

The company is still awaiting final regulatory approval for Illuccix from the US healthcare regulator the FDA and has product approval applications awaiting in Canada and Europe.

Telix shares are up 785 per cent over the past five years and last closed at $6.64 on a market value around $1.9 billion.

meaning

Telix Pharmaceuticals is set to earn its first sales revenues for its prostate cancer imaging product Illucix in early 2022 after the US healthcare regulator approved its use on Monday.

Shares raced to a record high $8.20 in response to the news and are now up more than 950 per cent in five years as investors sense Telix’s potential as an industry leader in using nuclear medicine to diagnose and treat common cancers in patients.

Chief executive Chris Behrenbruch declined to provide a 2022 sales forecast after the approval of the Food and Drug Administration (FDA), but said Telix was ready to launch the product.

“This is a product that addresses a very big unmet medical need, and we’re really proud that an Aussie company is going to have such a big impact on prostate cancer care in the US,” he said.

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“Illucix has two major applications,” said Dr Behrenbruch. “One in high-risk men before having surgery to make sure you’re getting all the disease. Sometimes it’s spread out far to the prostate capsule, so you want to make sure that you’re doing the correct level of surgery and perhaps radiation. You want to make sure you’ve got everything.”

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The second application is for men that had an initial surgical intervention for their prostate cancer, and received a PSA test later on. “So when your PSA levels start to rise, it means somewhere in your body is a spec[k] of cancer,” Dr Behrenbruch said.

“And we can in many cases find that spec of cancer ... so it’s really about trying to stop the train before it leaves the station and have that patient come back as a metastatic patient later in life.”

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​

Dona Ferentes said:

meaning

Telix Pharmaceuticals is set to earn its first sales revenues for its prostate cancer imaging product Illucix in early 2022 after the US healthcare regulator approved its use on Monday.

Shares raced to a record high $8.20 in response to the news and are now up more than 950 per cent in five years as investors sense Telix’s potential as an industry leader in using nuclear medicine to diagnose and treat common cancers in patients.

Chief executive Chris Behrenbruch declined to provide a 2022 sales forecast after the approval of the Food and Drug Administration (FDA), but said Telix was ready to launch the product.




The second application is for men that had an initial surgical intervention for their prostate cancer, and received a PSA test later on. “So when your PSA levels start to rise, it means somewhere in your body is a spec[k] of cancer,” Dr Behrenbruch said.

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Post fda announcement price dropped.
Market was expecting this ?