Cash Burn Rate - Rough Timeline - Financing Repost.... timeline and burn looking good lately.
Lead PDC selected TLD1433
IND application meetings slated for this quarter.
GMP PDC production for toxicity analysis might be ahead of schedule... previous press release had this listed for Q2 but this press release says they're starting now.
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#### CASH January 10,2015 - 2M plus ####
-1Q2015 PDC - LEAD PDC Selected. TLD1433
-1Q2015 PDC - Optimization of the dose of laser light and PDC required in its orthotopic rat model to further refine this procedure for the destruction of bladder cancer in a live animal model.
-1Q2015 PDC - Conduct Health Canada Clinical Trial Application ("CTA") / Food and Drug Administration ("FDA") Investigational New Drug ("IND") meetings
#### END OF Q1 - BURN 450K - CASH 1.55M ####
-2Q2015 PDC - Complete pre-Good Manufacturing Practices ("GMP") and GMP manufacture of lead drug - Jan15 Press release. Now that the decision has been made to proceed with TLD-1433, Theralase will ramp up production of both non Good Manufacturing Practice ("GMP") and GMP batches of TLD-1433 for our toxicity analysis and human clinical trials slated for 2015.
-2Q2015 PDC - Identification of toxicity laboratory and completion of toxicity analysis of the lead compound in 2 different animal species
#### END OF Q2 BURN 450K - CASH 1.1m ####
-2Q2015/3Q2015 TLT - Waiting to see TLC2000 sales data/traction
-2Q2015/3Q2015 PDC - Health Canada and FDA CTA / IND Regulatory Approval
-3Q2015 PDC - Commence enrolling subjects into Health Canada / FDA Phase I / II a bladder cancer clinical study for NMIBC (Pending Regulatory Approval)
RE:Cash Burn Rate
Burn rates/balance sheet etc.... numbers are available from TLT financials... also interviews, newsletters and published articles/coverage and it has been discussed on the boards. Tuesday and other criminal bashers on this board are idiots... reference/contact TLT for your numbers/material information. Reference 3rd party coverage/all opinions collectively and make your own determinations.
### Theralase: ###
https://theralase.com/wp-content/uploads/2014/10/Annual-Information-Form-2014.pdf
https://www.sedar.com/DisplayProfile.do?lang=EN&issuerType=03&issuerNo=00002603
Address: 1945 Queen Street East Toronto, Ontario M4L 1H7, Canada
Hours: Monday - Friday 9:00am - 5:30pm (EST)
Toll Free: 1-866-TheLase (843-5273)
Local Phone: 416-699-LASE(5273)
Fax: 416-699-5250
info@theralase.com
CEO
Roger Dumoulin-White
President & CEO, Theralase Technologies Inc.
1.866.THE.LASE (843-5273) ext. 225
416.699.LASE (5273) ext. 225
rwhite@theralase.com
www.theralase.com
### Articles ### (most articles 6 to 12 months old, timelines out of sync, FYI)
https://seekingalpha.com/instablog/19040961-e-vestorsgroup/2601761-theralase-technologies-inc-the-greatest-story-never-told
https://www.midasletter.com/2014/02/theralase-technologies-inc-cure-cancer/
https://www.cantechletter.com/2014/04/roger-white-ceo-theralase-talks-cantech-letter/
https://investorshub.advfn.com/Theralase-Technologies-Inc-TLTFF-27817/
https://seekingalpha.com/article/2206433-initiation-report-for-theralase-technologies
https://www.siliconinvestor.com/subject.aspx?subjectid=59473
https://scr.zacks.com/files/Dec-2-2014_V-TLT_Marckx_v001_m30w39.pdf
------------
Below are some of my updated numbers/dd/timelines collected posts etc..... food for thought.
-----------------------------------------------
### Jan2015 - A good stockhouse post from Cirrus ###
https://www.stockhouse.com/companies/bullboard/v.tlt/theralase-technologies-inc?postid=23306288
Sept 30/2014 Cash: $2,141,487
Sept 30/2014 Current Assets: $3,339,272
Sept 30/2014 Warrants outstanding: 8,802,833
Warrants exercised since Sept 30: 3,816,700
Proceeds from warrants: $877,841 (assume av. exercise price of $0.23)
Q3/2014 loss: $1,048,034
Estimated Jan 9/2014 cash position: $1,969,328 ($2,141,487+$877,841-$1,050,000)
Estimated Warrants outstanding: 4,986,122
Estimated value of outstanding warrants: $1,146,808 (assume av. strike price of $0.23)
In my opinion TLT has access to enough cash for 3 quarters at their Q3/2014 burn rate. This is before adding sales of the TLC-2000 or adding expense for the human trials.
For the TLC-2000, I'm estimating 2015 sales of 300 units for total revenue of $4.5 million, or approx. $1.1 million / quarter.
Cirrus
---------------------------------------------
### November Kereport Interview discussing cash ###
https://www.kereport.com/2014/11/29/opec-renewable-energy-sector-markets/
7:06
As of Nov 29th
2.2M Cash
Fully financed to launch TLC2000 and commence work required for PDT technology and obtain approvals for clincal trials. Projected sales traction for 2015 to 2016 provides ample capital to company to offset costs of clinical tirals and development of photo dynamic compounds... may be need for funding but if so, will be mitigated or reduced by sales of TLC2000.
---------------------------------------------
### Here is a good conlsusion to the topic of TLC2000 sales from Cory Fleck: kereport.com from their newsletter ###
Current burn rate is between 100k and 125k / month – this includes both divisions
This amount could rise to 150k/month as the cancer research ramps up in preparation for the clinical trials
The new TLC-2000 will sell for $15,000 with a profit margin of 75%
Cash as at June 30th, 2014 was 2,808,047. We can assume the cash position in mid November 2014 is $2.1 Million.
"After chatting to Roger White regarding the expected sales of the TLC 2000 he states that they hope to sell around 100 units in the first three months after hitting the market (which is roughly 33 units per month). For conservative sake we will use a lower figure of 15 units to run our numbers. We will also use a profit margin of 70% instead of 75%. Over my time investing, conservative estimates have never lead me astray.
If Theralase can sell 15 units a month at a 70% margin the company would generate $157,500/month. This number would cover the 150k/month of operating expenses and the continued cancer division research.
As I stated above, the therapeutic division provides a base to the stock price. We should not expect booming sales of the TLC-2000 to catch investor’s eyes. Rather, strong sales will further result in a steady stream of cash entering the company to offset the costs of starting the cancer trails."
-----------------------------------------
### Timing - Cash - Burn - TLC Delays/Launch/Traction - Trial Commenment - misc. ###
https://www.investing.com/analysis/theralase:-a-cancer-cure-to-market-by-2016-204637
"Upon successful completion of the orthotopic rat trial, in which the company will induce cancer in the bladder of a rat, Theralase plans to initiate a 30 patient Phase 1/2a clinical trial in Q1 2015, for which the company is fully funded. Theralase's treatment meets the initial two criteria for breakthrough designation, which are that it targets a deadly disease and that the disease has no known cure. This is important because it means all the company needs to do is demonstrate safety and efficacy in a small sample of patients—the purpose of the planned Phase 1/2a trial—in order to get commercialization approval for the FDA. This could lead to the PDC treatment being available to patients by year-end 2015. Even if the FDA requires further data after the initial trial, a Phase 2b trial would likely cost less than $15M, which would be minimally dilutive to Theralase stock. Post approval, the ultimate goal is a partnership with big pharma during 2016."
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BEFORE fixation on 15m figure, reminder that 15M figure is for a Phase 2b trial not Phase 1/2a (2015 fully funded).... expense for Phase 2B (if needed) would be in 2016 where financing at that time would be needed, OR the TLC2000 sales would carry us.
15M to complete Phase 2b
2b is the significant cost and may not even be necessary.
Phase 1/2a is not as significant and is fully funded per TLT
-----------------------------------------
THESE ARE MY OPINIONS ONLY. DO YOUR OWN DD
Phase 1/2a is lined up for 2015 per this rough timeline which is what the TLC2000 sales traction could possibly carry pending final regulatory approvals, launch and sales traction. Cash would cover us until well into second half of 2015 so we can afford that delay.
End of January 2015, lets say TLC1000 revenue has been slim for 4Q2014 and 1Q2015and burn rate is 150k/month. That would put current Cash position at around 1.7M to 1.9M
TLC2000 sales should pick up around (modest) 150k month(selling just 15 units month) starting at latest in the 2nd quarter 2015, reported Q3. Hopefully q1 as currently suggested by TLT and reported q2.
Approximate/Rough timeline.
-4Q2014 TLT - Transition from TLC1000 to not yet released TLC2000 will likely see light 4Q2014 sales numbers as customers wait for new product
-1Q2015 TLT - TLC2000 - Approvals - Hoping to see Regulatory approvals first quarter
-1Q2015/2Q2015 TLT - TLC2000 - Launch - "Theralase will launch the patented, next generation TLC-2000 biofeedback therapeutic laser system in Canada in 1Q2015 and in the US in 2Q2015."
-1Q2015 PDC - Optimization of the dose of laser light and PDC required in its orthotopic rat model to further refine this procedure for the destruction of bladder cancer in a live animal model.
-1Q2015 PDC - Conduct Health Canada Clinical Trial Application ("CTA") / Food and Drug Administration ("FDA") Investigational New Drug ("IND") meetings
#### END OF Q1 - BURN 450K - CASH 1.25M ####
-2Q2015 PDC - Complete pre-Good Manufacturing Practices ("GMP") and GMP manufacture of lead drug
-2Q2015 PDC - Identification of toxicity laboratory and completion of toxicity analysis of the lead compound in 2 different animal species
#### END OF Q2 BURN 450K - CASH 800K ####
-2Q2015/3Q2015 TLT - Waiting to see TLC2000 sales data/traction
-2Q2015/3Q2015 PDC - Health Canada and FDA CTA / IND Regulatory Approval
-3Q2015 PDC - Commence enrolling subjects into Health Canada / FDA Phase I / II a bladder cancer clinical study for NMIBC (Pending Regulatory Approval)
-3Q2015 TLT - TLC2000 international sales targetted
#### END OF Q3 BURN 450k to 600K - CASH = 200K to 400k + TLC2000 SALES ####
(600K q3 burn for increased expense for trials and TLC2000 sales admin, offset by TLC2000 sales which even with delays should be adding up by Q3, cash becomes 200K-400k plus TLC2000 sales.
This obviously becomes the point where financing is really needed or not.... cash getting low, trial expenses while reasonable for phase 1/2a are they adding up? and tlc 2000 offset... generating revenu yet? does tlc2000 start firing sales out in February, April, August? It wouldn't take much to offset but obviously if things got tight and TLC can get a good financing at a premium, that would be great... it would allow all divisions (PDC-BLADDER. PDI-BACTERIA, TLT-TLC2000) to fire on all cyclnders operationly speaking and create what could be exceptional shareholder value. So if financing not needed by tlc2000 sales offset and good timing, then great. If financing obtained at premium (any time, now to Q3) and allows accelerated operations/research, great!)
-3Q2015/4Q2015 - PDC - Trials commenced - Treatments started
-4Q2015 PDC - Twelve week followups *starting?* in this period
-1Q2016 - PDC- Final data compiled/ complete phase 1/2a bladder clinical trial - results submitted to FDA
-2016 Waiting for FDA approval/feedback for fasttrack/commercialization
-New Drug Application (NDA)
Theralase believes they have a 99% chance of achieving Fast Track Status and after completion of a successful Phase 1/2a clinical trial over a 90% chance of achieving Breakthrough Status.
https://www.youtube.com/watch?v=SL0Di9A0SGg
3:40 of this video talks more timelines, Phase 1/2a would be completed 2015, Phase 2b would be 2016. Phase 3 if needed would be in to 2018
2016
(DOES Phase 1/2a trial demonstrate safety and efficacy and does treatment qaulify for Fasttrack??? YES=commercialization NO=Phase 2b)
YES = PDC approval-Commercialize PDC!
NO = FDA needs more data - 2016 - Commence Phase 2b (15M approx. cost if needed)
----------------------------------------
Some financing/prep work covered already? Trial ramp/expense offset?
Sigma and JSS inital payments were paid inQ4.
Considers increased preclinical research/admin expense prepping for trials and starting trials and considers just modest revenue from tlc2000 in next two quarters.. this should get us three quarters away from now, q2/q3 2015 before financing is needed.
### A lot of the timing for self sufficiency is dependent on TLC2000 delays, once ready, they have a game plan.... mind you that gameplan (sales admin/operations/manufacturing) cost money too.... that's where the lease plan w/ 16500 up front to TLT makes great sense here. I see Q2/Q3 as the turning point financially but would be happy with financing at market premium at any time if it meant all divisions being fully operational without cash restrictions, there are pros to that too.
Theralase plans to have sales managers in Calgary, Vancouver, Toronto, Montreal, New York, Los Angeles, Miami, Chicago and Houston in 2014 and 2015. If the TLC-2000 technology is disruptive which it appears to be and the increased sales effort penetrates the US market, then the modest tlc-2000 projections could turn into significant and a good situation where those revenues return to 2013 tlc1000 levels and beyond which can carry TLT through human clinicals. New US CPT code ready for the Janurary books? Cold laser therapy reaching critical mass? Theralase the best in the business? We could be really surprised when the brand and therapy get the recognition it deserves.
---------------------------------
Financing scenarios that I see....
1. 10M-20M - This is the originally mentioned number that TLT was targetting. Possible if stock price justifies and premium on top of that and TLT can justify early/immediate availability/need of cash... in that case, I'd be fine with this any time to benefit all divisions starting now.
2. 5M-10M - This is the second mentioned number from TLT/Roger as he downgraded the original number and mentioned warrant execution, current cash, net burn /possible tlc2000 traction able to keep them going for quite awhile. If it comes to this, it would be because the tlc2000 sales traction is slow and/or DELAYED (which as of Jan2015 is a possibility... waiting on regulatory approvals) and/or TLT sees opportunity/reason to push/accelerate with more money, or because stock price is high enough/investor has lined up willing to pay reasonable premium for a piece of the pie and TLT bites at the financing.
3. none - speculative and remotely possible is that tlc2000 traction is good enough and timed well enough parallel to trial timing that we squeak by without needing financing. in this scenario I actually don't mind some minor delays but at the same time am enticed by financing and TLT having all cash to fire all divisions all directions, there is value in that too
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I'd say we have about a 90% liklihood of seeing a minimally dilutive financing sometime in the next 6 months, anywhere from 1M to 15M but I'd put it at somewhere around .70c to $1 per share. Perhaps 5 to 10% dilution of shares but for the greater good and last stop before take off. 10% chance of no financing where we pull off a super timed 2015 with great tlc2000 traction or other finance option to squeak us through the year
.
However you look at it... I'd give a 6 month timeline flex/tolerance without any significant worry... delays are semipositive in my perspective since they can ensure doing things right the first time and allowing tlc2000 sales to carry us. I don't see any financial risk with or without financing... ..... invest for 2016, even if they need to finance, imo, it won't hurt shareholder value. Even if PDC is a complete and utter failure and crashes the sp, the TLC2000 sales by 2016 would still be worth .50c a share once the shock settled. I'm confident Roger won't unreasonably dilute.. but I guarantee you there are people lined up to give him money if he wants it.
Rewrite my entire post with 50% less enthusiasm, increased costs and even less modest sales projections and you still have an amazing opportunity if you consider just the science/facts.... tlt pdc cancer treatment, vaccine, light delivery hardware tlc3000, cold laser therapy tlc2000, tlt pdi bacteria solutions (new division coming??) and if it continues its current success/validation into commercialization, look out! Show me something on any exchange with the same potential with even a 5th of the risk and only a 10th of the potential reward that TLT does with a market cap of 30m? OH right, Jan11,2015 40M market cap now. I guess that's all the fun eh, trying to come up with those determinations isn't an exact science but I see a lot to like here.