Theralase Technologies Inc. V.TLT

Real Efficacy

[Eoganacht]

The following table is derived from the one in the 2Q2021 Newsletter released in November 2021. I have removed the 3 patients from phase 1b and the pending patients in order to show the results for the evaluable patients. At 450 days only the first 12 patients (plus 1 other patient) were evaluable.

Assessed	90 Days		180 Days		270 Days		360 Days		450 Days
	#	%	#	%	#	%	#	%	#	%
CR	12	52%	5	29%	5	33%	2	14%	2	15%
IR	4	17%	5	29%	2	13%	4	29%	2	15%
TR	16	69%	10	59%	7	46%	6	43%	4	30%
NR	7	30%	7	41%	8	53%	8	57%	9	70%
Evaluable	23		17		15		14		13

At this point in time, none of the patients who had received 2 optimized treatments had made it to 450 days. I think the reason there are 13, rather than 12 evaluable patients here is because they may have included the patient who had a negative cytology after their initial treatment but died 35 days into the trial. It looks like 3 or 4 of the iniial 12 made it to 450 days with either a total or partial response. This is not all that surprising considering that one optimized treatment may be all that is really needed.I believe this means that we are only justified in removing the first 8 patients from the results as they received no optimized treatment at all and had almost no chance of a lasting response.If we remove those 8 and redraw the most recent (May 10) results table I think we will have a much better read on the real current efficacy of the treatment:

Assessed	90 Days		180 Days		270 Days		360 Days		450 Days
	#	%	#	%	#	%	#	%	#	%
CR	31	70%	24	62%	17	52%	12	36%	11	38%
IR	3	7%	8	20%	5	15%	0	0%	1	3%
TR	34	77%	32	73%	22	67%	12	39%	12	41%
NR	10	23%	7	17%	11	33%	19	61%	17	59%
Evaluable	44		39		33		31		29

In 270 days if 8 of the 9 CR's waiting in the wings maintain their CRs, the real 450 day efficacy (without the initial 8 unoptimized patients) may look like this:

Assessed	450 Days
	#	%
CR	19	48%
IR	1	3%
TR	20	51%
NR	19	49%
Evaluable	39

That's double the durable CR rate of the recently approved Adstiladrin.