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OTC:EDTXF / TSX:EDT - Spectral Medical Inc. - 10/14/2015 10:05:09 AM   
minvestor42

 

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Spectral Medical Inc. (TSX:EDT / OTC:EDTXF) is Toronto-based pharmaceutical company enrolling the final 75 patients into the only active Phase III clinical trial for a theranostic (diagnostic/therapeutic combination) treatment for severe sepsis and septic shock, a deadly condition which is the most common cause of death in people who have been hospitalized.

The treatment consists of a diagnostic device developed by Spectral (EAA, Endotixin Activity Assay; already approved by the FDA and Health Canada) used for determining the patients eligibility for treatment (based on endotoxin levels in the blood), and the Toraymyxin PMX, a blood filtration catridge which can be used with a dialysis machine to filter those identified toxins out of the blood.
Spectral owns the commercialization rights for the Toraymyxin PMX cartridge in North America, a device developed by Toray Industries which has already been used to treat 100,000+ patients in Japan and Europe, and has already shown efficacy in Japanese and European clinical trials (EUPHAS and EUPHAS2).

There is currently no effective treatment for servere sepsis and septic shock, despite it affecting around 300-350 thousand people in North America per year (a portion of the 1,000,000+ people who will develop sepsis annually in North America) and having a mortality rate in excess of 50%. Spectral expects ~175,000 patients out of the 300-350 thousand who develop severe sepsis to be eligible for treatment with the Toraymyxin PMX catridge (eligibility is dependent on Endotoxin levels in the blood), and for the revenue per patient to be ~$20,000 USD. This amounts to an untapped market of potentially $3+ billion USD annually (assuming 100% market penetration).

Spectral is engaged in a rolling pre-market approval consisting of 4 modules, of which 2 have been submitted to the FDA with the 3rd expected to be submitted by the end of Q4 2015.
On September 14th 2015, a sample-size recalculation was approved by the DSMB (Data Safety and Monitoring Board) reducing the overall patient enrollment by 251 and cutting down the time to clinical trial completion significantly. Current patient enrollment is expected to be completed by the end of Q2 2016 (current enrollement rate of 8 patients per month with 75 patients left to enroll) and topline data should be available shortly thereafter. The application for FDA approval is scheduled to be presented to the FDA in Q4 2016.
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RE: OTC:EDTXF / TSX:EDT - Spectral Medical Inc. - 10/19/2015 9:51:13 AM   
minvestor42

 

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New press release today:

quote:

Body of Evidence Supporting the Use of Toraymyxin™ for Treatment of Septic Shock Continues to Grow

TORONTO, ONTARIO--(Marketwired - Oct. 19, 2015) - Spectral Medical Inc. ("Spectral" or the "Company") (TSX:EDT)(OTCQX:EDTXF), a Phase III company developing the first treatment for patients with septic shock that comprises a therapeutic device guided by a companion diagnostic, today announced that the medical literature supporting the use of Toraymyxin™ ("PMX") for the treatment of septic shock patients continues to grow. Peer-reviewed articles, observational studies and case reports of PMX use outside of North America conclude that this medical device is safe and effective. Upon approval, this unique treatment could potentially save tens of thousands of lives in the United States and Canada annually and solve a very significant unmet medical need.

The Company has filed its annual updated Report of Previous Investigations ("ROPI") with the United States Food and Drug Administration ("FDA"). ROPI comprises all available published literature reporting use of PMX over a 22 year period (from 1993 to September, 2015). To date, published articles on the use of PMX have reported on over 140 individual studies that included approximately 4,400 patients who have received approximately 7,600 PMX perfusions. The safety profile of PMX continues to be excellent, with the number of treatment related serious events being very low. The majority of the product use has been in Japan, but utilization of PMX in Europe and other regions is now increasing.

"Taken as a whole, the papers reporting data on PMX use outside of North America report positive patient outcomes, especially for patients with similar characteristics as those of patients in our EUPHRATES trial," said Debra Foster, Vice President of Clinical Development for Spectral. "Furthermore, we are seeing more and more reports that outline how our EAA™ diagnostic has helped to effectively guide patient treatment as the concept of personalised medicine gains traction for the management of critical illness, including septic shock," added Ms. Foster.


Link to release

(in reply to minvestor42)
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RE: OTC:EDTXF / TSX:EDT - Spectral Medical Inc. - 10/21/2015 9:16:24 AM   
minvestor42

 

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Another new press release today:

quote:

Spectral and Toray Medical Sign Exclusive EAA™ Distribution Agreement for 15 Countries in the Middle and Far East

TORONTO, ONTARIO--(Marketwired - Oct. 21, 2015) - Spectral Medical Inc., ("Spectral" or the "Company") (TSX:EDT)(OTCQX:EDTXF), a Phase III company developing the first treatment for patients with septic shock that comprises a therapeutic device guided by a companion diagnostic, today announced that it has entered into an exclusive agreement with Toray Medical Co., Ltd. (TMC), to distribute Spectral's rapid test for the assessment of endotoxin activity in human whole blood (EAA™) across 15 countries in the Middle and Far East: India, South Korea, Taiwan, Singapore, Thailand, Malaysia, Indonesia, Philippines, Vietnam, Cambodia, Myanmar, Brunei, Laos, the Kingdom of Saudi Arabia, and Republic of Turkey. The diagnostic will be sold in conjunction with the Toraymyxin™ ("PMX") hemoperfusion cartridge, which medical device removes endotoxin from the bloodstream, to help guide patient treatment. Spectral is now in the later stages of a Phase III registration trial as it seeks FDA approval for the PMX medical device in the United States.
"We are very pleased to expand our strategic alliance with TMC, as it is already a distributor for EAA™ in Japan. This agreement provides further evidence of the growing recognition that our diagnostic plays a key role in the identification of patients in septic shock who are most likely to benefit from the PMX treatment," said Dr. Gualtiero Guadagni, Vice President of Sales and Marketing for Spectral. "We expect that the utilization of EAA™ should continue to increase worldwide, especially after the completion of our North American EUPHRATES trial next year," added Dr. Guadagni.

(in reply to minvestor42)
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RE: OTC:EDTXF / TSX:EDT - Spectral Medical Inc. - 1/11/2016 10:37:33 AM   
minvestor42

 

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Big update:

quote:

Spectral Medical Provides Clinical and Regulatory Update
- Trial enrolment is 90% complete
- Company is on track to submit for FDA market approval in H2 2016

TORONTO, ONTARIO--(Marketwired - Jan. 11, 2016) - Spectral Medical Inc., ("Spectral" or the "Company") (TSX:EDT)(OTCQX:EDTXF), a Phase III company developing the first treatment for patients with endotoxemic septic shock that comprises a therapeutic device guided by a companion diagnostic, today announced that it is now recruiting the last 46 patients into its pivotal Phase III EUPHRATES trial. Based on current enrolment rates, it is expected that the trial should be completed in the first half of 2016.
To date, 400 patients have been enrolled into the trial, representing 90% of the total estimated sample size of 446 evaluable patients. The composite mortality rate of approximately 50% for patients randomized since the April 10, 2014 protocol amendment remains consistent with the assumptions used for the recent sample size recalculation which was accepted by the US Food and Drug Administration ("FDA").
The Company further announced that it is on track to submit the fourth and final Pre-Market Approval ("PMA") module containing clinical data to the FDA for market approval of its Toraymyxin™ ("PMX") medical device in the second half of 2016. The first three modules of the PMA were submitted in 2015 in accordance with the rolling submission timelines previously agreed with the FDA.
"We are now in the final stages of program execution to reach our goal of solving a very large unmet medical need in the area of septic shock, a condition which kills over 300,000 people in North America each year," said Dr. Paul Walker, President & CEO of Spectral Medical. "We are becoming more confident each day about achieving a positive outcome for our clinical trial and a subsequent successful product launch into a $3 billion market where there are currently no other approved therapies for endotoxemic septic shock."

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New analyst report by Mackie Research - 1/13/2016 10:07:32 AM   
minvestor42

 

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Mackie Research has started coverage of Spectral Medical with a target price of $2.50 (212.50% increase) and a speculative buy rating. Should be the first of many such reports.

http://beanstockd.com/spectral-medical-inc-edt-given-speculative-buy-rating-at-mackie/240621/

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Full Mackie Research report - 1/15/2016 10:07:21 AM   
minvestor42

 

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Just found the full Mackie Research report posted on the Spectral stockhouse bullboards, looks pretty thorough.

Here's the link.

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Spectral Medical Inc. Announces $10,010,000 Bought Deal... - 2/1/2016 2:47:07 PM   
minvestor42

 

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Spectral Medical Inc. Announces $10,010,000 Bought Deal Financing

Thursday, January 28, 2016
Spectral Medical Inc. Announces $10,010,000 Bought Deal Financing

08:04 EST Thursday, January 28, 2016

TORONTO, ONTARIO--(Marketwired - Jan. 28, 2016) -
NOT FOR DISTRIBUTION TO U.S. NEWSWIRE SERVICES OR FOR DISSEMINATION IN THE UNITED STATES
Spectral Medical Inc. ("Spectral" or the "Company"), (TSX:EDT)(OTCQX:EDTXF) is pleased to announce that it has entered into an agreement with a syndicate of underwriters led by Cormark Securities Inc. (the "Lead Underwriter" and collectively, the "Underwriters"), pursuant to which the Underwriters have agreed to purchase 14,300,000 common shares ("Shares") from the treasury of the Company, at a price of $0.70 per Share and offer them to the public by way of short form prospectus (the "Offering").
In addition, the Company has granted the Underwriters an option ("Over-Allotment Option") to purchase up to an additional 2,145,000 Shares from the treasury of the Company at the offering price exercisable at any time up to 30 days following Closing (as defined below), for market stabilization purposes and to cover over-allotments, if any.
The net proceeds of the Offering will be used for the completion of the Company's EUPHRATES clinical trial, the commercialization of the Company's PMX device and for general corporate purposes.
Closing of the Offering is expected to occur on or about February 18, 2016 (the "Closing") and is subject to regulatory approval including that of the Toronto Stock Exchange.
The Shares to be issued under the Offering will be offered by way of a short form prospectus in each of the provinces of Canada, except Québec.
This news release does not constitute an offer of securities for sale in the United States. The securities being offered have not been, nor will they be, registered under the United States Securities Act of 1933, as amended, and such securities may not be offered or sold within the United States absent U.S. registration or an applicable exemption from U.S. registration requirements.

Link to full article: http://www.theglobeandmail.com/globe-investor/news-sources/?date=+20160128&archive=ccnm&slug=201601281041088001

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RE: Spectral Medical Inc. Announces $10,010,000 Bought ... - 2/17/2016 5:06:37 PM   
3829sunny

 

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Very interesting stock, i will be watching this!!

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RE: Spectral Medical Inc. Announces $10,010,000 Bought ... - 2/19/2016 4:36:36 PM   
trader91823

 

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Any idea what competitors are in this space? The reports I've seen on this stock shows some huge market potential, but with that would come a bunch of other company looking to get into this space id expect. I will be very interested in what the next 6-12months brings.

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RE: Spectral Medical Inc. Announces $10,010,000 Bought ... - 2/22/2016 12:11:49 PM   
3829sunny

 

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from what I've seen there is no other competitors in this market, there are other companies in phase 1 trials but nothing that is as close to being available in the market.

heres the companies latest investors resource update, it has the answers to most of your questions.
http://www.spectraldx.com/assets/spectral-medical-ir-jan2016.pdf


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RE: Spectral Medical Inc. Announces $10,010,000 Bought ... - 2/24/2016 2:58:38 PM   
minvestor42

 

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New press release today:

quote:

PRESS RELEASE FROM MARKETWIRE
Spectral Medical Inc. Closes Over-Allotment
Wednesday, February 24, 2016

Spectral Medical Inc. Closes Over-Allotment
08:34 EST Wednesday, February 24, 2016
TORONTO, ONTARIO--(Marketwired - Feb. 24, 2016) -

NOT FOR DISTRIBUTION TO U.S. NEWSWIRE SERVICES OR FOR DISSEMINATION IN THE UNITED STATES

Spectral Medical Inc. ("Spectral" or the "Company"), (TSX:EDT)(OTCQX:EDTXF) announced today that the underwriters for the Company's bought deal offering have partially exercised their over-allotment option to purchase an additional 806,804 common shares of the Company (the "Over-Allotment Shares") at a price of $0.70 per share from the treasury of the Company. The sale of the Over-Allotment Shares increases the gross proceeds to the Company by approximately $564,763, resulting in total gross proceeds under the offering of approximately $10,574,763.

The offering was made through a syndicate of underwriters led by Cormark Securities Inc. and including Mackie Research Capital Corporation.

The net proceeds of the offering will be used for the completion of the Company's EUPHRATES clinical trial, the commercialization of the Company's PMX device and for general corporate purposes.

This news release does not constitute an offer of securities for sale in the United States. The securities being offered have not been, nor will they be, registered under the United States Securities Act of 1933, as amended, and such securities may not be offered or sold within the United States absent U.S. registration or an applicable exemption from U.S. registration requirements.

[/quote]

link: http://www.theglobeandmail.com/globe-investor/news-sources/?date=+20160224&archive=ccnm&slug=201602241044257001

< Message edited by minvestor42 -- 2/24/2016 2:59:12 PM >

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RE: Spectral Medical Inc. Announces $10,010,000 Bought ... - 3/1/2016 9:49:46 AM   
minvestor42

 

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PRESS RELEASE FROM MARKETWIRE
Spectral Approaches Finish Line For Clinical And Regulatory Program
Only 30 Patients Remaining to Enrol for Trial Completion in 1H2016 Final PMA Module on Track for Submission in 2H2016 Multiple Potential Commercialization Partners Expressing Interest

Tuesday, March 01, 2016

Spectral Approaches Finish Line for Clinical and Regulatory Program
08:00 EST Tuesday, March 01, 2016
TORONTO, ONTARIO--(Marketwired - March 1, 2016) - Spectral Medical Inc. ("Spectral" or the "Company") (TSX:EDT)(OTCQX:EDTXF), a Phase III company developing the first treatment for patients with endotoxemic septic shock that comprises a therapeutic device guided by a companion diagnostic, today announced that it is now recruiting the remaining 30 patients into its pivotal Phase III EUPHRATES trial. Based on current enrolment rates, it is expected that the trial should be completed in the first half of 2016.

To date, 416 patients have been enrolled into the trial, representing 93% of the total estimated sample size of 446 evaluable patients. In addition, the composite mortality rate of approximately 50% for patients randomized since the April 10, 2014 protocol amendment remains consistent with the assumptions used for the recent sample size recalculation which was accepted by the US Food and Drug Administration ("FDA").

The Company further announced that it continues to be on track, with its strong trial enrolment rate and assuming positive results, to submit the fourth and final Pre-Market Approval ("PMA") module containing clinical data to the FDA for market approval of its Toraymyxin™ ("PMX") medical device in the second half of 2016. The first three modules of the PMA were submitted in 2015 in accordance with the rolling submission timelines previously agreed with the FDA.

Following successful completion of its recent financing, the Company has approximately $14 million of cash on hand to fund operations through to potential market launch. The Company's primary strategy is to build its own sales and marketing infrastructure for commercialization of the PMX treatment for endotoxemic septic shock. However, the Company has engaged third party advisors to facilitate discussions with a number of potential interested commercialization partners and it expects that these discussions and others will continue as it moves closer to trial completion and the availability of data. There is no assurance, however, that any such discussions will result in agreement or arrangement with a third party to commercialize the PMX treatment.

"This is a very exciting time for the Company and its shareholders as our clinical, regulatory and commercialization programs are all coming together for the purpose of achieving what we believe will be a successful outcome for our rigorously developed and carefully executed six year clinical trial and a subsequent successful product launch into a $3 billion market where there are currently no other significant competitors to our therapy," said Dr. Paul Walker, President and CEO of Spectral Medical.

link: http://www.theglobeandmail.com/globe-investor/news-sources/?date=+20160301&archive=ccnm&slug=201603011044960001

(in reply to minvestor42)
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RE: Spectral Medical Inc. Announces $10,010,000 Bought ... - 3/2/2016 12:27:26 PM   
3829sunny

 

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great news with the latest news article from yesterday!

< Message edited by 3829sunny -- 5/6/2016 2:49:54 PM >

(in reply to minvestor42)
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RE: Spectral Medical Inc. Announces $10,010,000 Bought ... - 3/7/2016 2:31:52 PM   
minvestor42

 

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PRESS RELEASE FROM MARKETWIRE
Spectral Commends Inclusion Of Organ Dysfunction In New Expert Consensus Definitions Of Sepsis And Septic Shock
New sepsis definitions align with Spectral's pivotal trial design for Toramyxin(TM)

Monday, March 07, 2016

Spectral Commends Inclusion of Organ Dysfunction in New Expert Consensus Definitions of Sepsis and Septic Shock
07:00 EST Monday, March 07, 2016
TORONTO, ONTARIO--(Marketwired - March 7, 2016) - Spectral Medical Inc. ("Spectral" or the "Company"), (TSX:EDT) (OTCQX:EDTXF) a Phase III company advancing a precision treatment targeting specific patients at high risk of death from septic shock, today commented on the potential life-saving ramifications of the recently announced Third International Consensus Definitions for Sepsis and Septic Shock. Specifically, Spectral cites the definitions' new emphasis on organ dysfunction as a major contributor to the underlying pathology of sepsis and the main cause of death from septic shock. The updated definitions were issued on Feb. 23rd by a joint task force convened by the Society of Critical Care Medicine and the European Society of Intensive Care Medicine and published online by the Journal of the American Medical Association1.

"We are pleased that these new definitions are fully consistent with the hypothesis and patient identification protocol of our Phase III EUPHRATES clinical trial for Toramyxin™, an investigational therapeutic hemoperfusion device that removes endotoxin from the bloodstream," said Dr. Paul Walker, President and Chief Executive Officer of Spectral Medical.

The EUPHRATES trial is nearing completion and is based on prior evidence that high levels of endotoxin are associated with organ dysfunction and increased mortality from septic shock. Investigational Toramyxin™ treatment for study eligible patients is guided by the Company's FDA-cleared Endotoxin Activity Assay (EAA™) which measures endotoxin levels in the blood. The new definition and its alignment with the Surviving Sepsis Campaign Guidelines are also reflected in the EUPHRATES study protocol which presumes that fluid resuscitation requirements have been met and that vasopressors are being used to maintain normal blood pressure in the patient.

Over 350,000 patients are diagnosed with septic shock in North America each year. An estimated 150,000 U.S. patients die annually from septic shock despite best practices employed by critical care and intensive care unit hospital staff. Septic shock is the most advanced and most lethal stage of sepsis.

http://www.theglobeandmail.com/globe-investor/news-sources/?date=+20160307&archive=ccnm&slug=201603071045723001

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RE: Spectral Medical Inc. Announces $10,010,000 Bought ... - 3/30/2016 12:07:15 AM   
3829sunny

 

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mivestor42, trader91823

just stumbled upon this video, VERY exciting times coming and i would expect the share price to finally get into that analyst expected range ($2.50/shr) prior to the results of the trial being made public.... HUGE potential for multibagger returns!!

here is the link to the video with the lead investigator:

http://www.stockhouse.com/companies/bullboard/t.edt/spectral-medical-inc/2?postid=24685160

(in reply to minvestor42)
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RE: Spectral Medical Inc. Announces $10,010,000 Bought ... - 3/31/2016 10:02:33 PM   
kwinvestor85

 

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CORRECTION FROM SOURCE: Spectral Announces Fourth Quarter and Fiscal 2015 Results
T.EDT | 1 day ago

TORONTO, ONTARIO--(Marketwired - March 30, 2016) -

This document corrects and replaces the press release that was sent today at 8:00 a.m. The error occured in the 4th Paragraph in Financial Review where $14,048 should be $14,048,000. The complete and corrected version follows.

Spectral Medical Inc., (TSX:EDT) (OTCQX:EDTXF), a Phase III company developing the first treatment for patients with septic shock guided by a companion diagnostic, today announced its financial results for the fourth quarter and for the year ended December 31, 2015.

Financial Review

Revenue for the three months ended December 31, 2015 was $715,000 compared to $699,000 for the same three month period last year. Revenue for the year ended December 31, 2015 was $3,089,000 compared to $2,964,000 for the prior year, representing an increase of $125,000, or 4%.

For the quarter ended December 31, 2015, the Company reported operating costs of $3,130,000 compared to $3,195,000 for the corresponding period in 2014. Operating costs for the year ended December 31, 2015 amounted to $12,696,000 compared to $13,125,000 in 2014. Most of the Company's expenses are incurred in its Phase III clinical trial and will vary depending on the timing and level of patient enrolment. Apart from clinical trial activities, the Company continues to maintain a low cost operating structure for its base business operations.

Loss for the quarter ended December 31, 2015 was $2,400,000 ($0.01 per share) compared to $2,463,000 ($0.01 per share) for the same quarter last year. For the year ended December 31, 2015, the Company reported a loss of $9,524,000, ($0.05 per share), compared to a loss of $9,492,000 ($0.06 per share), for the year ended December 31, 2014.

The Company concluded the 2015 year with cash and cash equivalents of $6,369,000 compared to $10,054,000 cash and cash equivalents on hand as of December 31, 2014. After closing of its bought deal financing subsequent to the year end, the Company had $14,048,000 of cash to fund its operations.

The total number of shares outstanding for the Company was 190,771,405 as at December 31, 2015.

http://www.stockhouse.com/news/press-releases/2016/03/30/correction-from-source-spectral-announces-fourth-quarter-and-fiscal-2015

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RE: Spectral Medical Inc. Announces $10,010,000 Bought ... - 4/13/2016 9:00:40 AM   
kwinvestor85

 

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article highlighting the increased awareness to the deadly killer that is spesis

http://www.huffingtonpost.com/2016/04/08/sepsis-in-america-us_n_9673288.html?utm_hp_ref=healthy-living&ir=Healthy+Living

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RE: Spectral Medical Inc. Announces $10,010,000 Bought ... - 5/12/2016 11:29:02 PM   
minvestor42

 

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May 12, 2016 08:00 ET

Spectral Announces First Quarter Results

TORONTO, ONTARIO--(Marketwired - May 12, 2016) - Spectral Medical Inc., (TSX:EDT) (OTCQX:EDTXF), a Phase III company developing the first treatment for patients with septic shock guided by a companion diagnostic, today announced its unaudited financial results for the first quarter ended March 31, 2016.

Financial Review
Revenue for the three months ended March 31, 2016 was $1,062,000 compared to $877,000 for the same three month period last year. First quarter revenues were consistent with prior year levels and this trend is expected to continue for the remainder of the year.
Operating costs for the quarter ended March 31, 2016 were $4,069,000 compared to $3,223,000 in 2015. Most of the Company's expenses are incurred in its Phase III clinical trial and will vary depending on the timing and level of patient enrolment. Apart from clinical trial activities, the Company continues to maintain a low cost operating structure for its base business operations.
Loss for the quarter ended March 31, 2016 was $2,994,000 ($0.02 per share) compared to $2,322,000 ($0.01 per share) for the same quarter last year.
The Company concluded the first quarter of 2016 with cash on hand of $12,861,000 compared to $6,369,000 as of December 31, 2015.
In February, 2016, the Company closed a bought deal prospectus financing for net proceeds of $9,042,000.
The total number of shares outstanding for the Company was 206,733,209 as at March 31, 2016.

Corporate Update
The clinical trial is on track to complete enrollment by the end of June, 2016. There will be a corporate update on clinical and regulatory activities to be released prior to the Annual General Meeting.

http://www.marketwired.com/press-release/spectral-announces-first-quarter-results-tsx-edt-2124288.htm

(in reply to kwinvestor85)
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RE: OTC:EDTXF / TSX:EDT - Spectral Medical Inc. - 5/14/2016 11:33:36 PM   
minvestor42

 

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MANAGEMENT’S DISCUSSION & ANALYSIS
(All figures are expressed in thousands of Canadian dollars)

This Management’s Discussion & Analysis (“MD&A”) for the year ended December 31, 2015 has been prepared to help investors understand the financial performance of the Company in the broader context of the Company’s strategic direction, the risks and opportunities as understood by management, and the key success factors that are relevant to the Company’s performance. Management has prepared this document in conjunction with its broader responsibilities for the accuracy and reliability of the financial statements, as well as the development and maintenance of appropriate information systems and internal controls to ensure that the financial information is complete and reliable. The Finance and Audit Committee of the Board of Directors has reviewed this document and all other publicly reported financial information for integrity, usefulness, reliability and consistency.

This MD&A is dated March 29, 2016 and should be read in conjunction with the consolidated financial statements for the years ended December 31, 2015, and December 31, 2014.

http://www.spectraldx.com/assets/spe...4-mda-2015.pdf

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RE: OTC:EDTXF / TSX:EDT - Spectral Medical Inc. - 5/18/2016 11:18:45 AM   
minvestor42

 

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Spectral Investor Presentation March 2016.

Highlights:

Sepsis: A Significant Unmet Medical Need
- Common: >30% of ICU admissions
- Extremely fatal with ~300K deaths/annum in the U.S.
- Current cost of managing sepsis at ~$20B/annum in the U.S.
- Sepsis is a global problem with no targeted treatments available
- Over 1M patients/annum are diagnosed with sepsis in the U.S.
- Spectral has the only viable solution in Phase 3 clinical trials

PMX Removes >90% of Endotoxin
- EUPHAS Study in Italy (2009) showed a reduction in mortality of 64 patients from 53% to 32%
- EUPHAS 2 registry of over 300 treated patients showed same survival rate as the EUPHAS study
- Analysis of over 2,000 patients in Japan (2014) showed a reduction in mortality from 47% to 34.5%
- Over 150,000 patients to date treated outside of North America reflect similar positive outcomes
- PMX saves the lives of 1 in 3 patients with septic shock and high endotoxin
- Data also shows that the sickest patients benefit most and that 2 column treatment is most effective (same as our EUPHRATES trial design)

The Clinical/Regulatory Pathway
- 424 patients randomized as of March 28/2016 (154 since April 2014 protocol amendment that refined patient selection)
- Sample size reset to 176 evaluable patients post April 2014 for primary 28 day mortality end point and statistical plan accepted by FDA ; 446 evaluable patients in total (previously 650)
- Trial enrolment now at 95%; expected trial completion in H1, 2016
- Current trend:
 ~ 50% composite mortality for randomized patients since April 2014
 ~ 60-65% mortality in untreated patients with similar characteristics
 ~ 40% mortality in similar treated European patients
 SUGGESTS ~ 20% ABSOLUTE REDUCTION IN MORTALITY
- 3 of 4 PMA modules have been submitted; Module 4 (clinical data) targeted for H2 2016

Investment Highlights
- Reputable and proven management team and board
- First mover advantage
-The only active Phase 3 clinical trial in septic shock, a deadly condition with a mortality rate >40%
-Statistical plan and regulatory pathway agreed with the FDA
- Over 150K patients in Japan and Europe have been treated with this safe and effective device
- $3B+ annual revenue market opportunity with no competition
-Spectral is targeting 150K + patients with septic shock in North America
-End user price of $20K to $30K per treatment
-40%+ EBITDA at full ramp up
- Well capitalized with ~$14M in cash post bought deal financing
- Clear path to submission for FDA approval in H2 2016
-FDA approved rolling PMA submission plan


link to full presentation:
http://www.spectraldx.com/assets/spectral-medical-ir-march2016.pdf

< Message edited by minvestor42 -- 5/18/2016 11:19:20 AM >

(in reply to minvestor42)
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