Tigris Trial Enrollment Reaches 76 Patients
Crude mortality results continue to exceed expectations
During the third quarter, the Company continued to experience momentum in Tigris Trial enrollment. Management is pleased to report positive progress on these initiatives to increase Tigris Trial enrollment, specifically:
- During and subsequent to the third quarter the Company enrolled an additional eleven patients, of which nine or approximately 80% came from new sites opened for enrollment in 2023;
- 76 patients enrolled to date and the Company continues to close in on its interim target of 90 patients, an important milestone as Spectral’s strategic commercial partner,
Baxter (BAX:NYSE), will have the opportunity to view the data as well as provide a second milestone payment to Spectral; - Addition of two new trial sites, the
Mayo Clinic andEmory Healthcare , subsequent to the third quarter bringing current total trial sites to 20; - During the third quarter, full transition from the incumbent CRO, Beaufort was completed;
Spectral Medical was featured in an episode of the ‘The Balancing Act’ airing on Lifetime TV (Advancing Therapeutic Options for Sepsis and Endotoxic Septic Shock - The Balancing Act) focused on advancing therapeutic options for sepsis and endotoxic septic shock, which was aired during the quarter; and- On
September 7, 2023 , Spectral completed a private placement of convertible notes for gross proceeds ofUSD$4,553,000 led by the Company’s strategic investorsBaxter andPinnacle Island LP .
Dr.
“We are taking measured, yet rapid action to maintain and even increase momentum in patient enrollment with a view to enrolling our interim count of 90 patients, which is expected to play as a major catalyst for the Company,” said
Financial Review
Revenue for three months ended
Operating expenses for the three months ended
Loss for the three months ended
The Company concluded the third quarter of 2023 with cash of
The total number of common shares outstanding for the Company was 278,576,261 at
About Spectral
Spectral is a Phase 3 company seeking
PMX is approved for therapeutic use in
Spectral is listed on the
Forward-looking statement
Information in this news release that is not current or historical factual information may constitute forward-looking information within the meaning of securities laws. Implicit in this information, particularly in respect of the future outlook of Spectral and anticipated events or results, are assumptions based on beliefs of Spectral's senior management as well as information currently available to it. While these assumptions were considered reasonable by Spectral at the time of preparation, they may prove to be incorrect. Readers are cautioned that actual results are subject to a number of risks and uncertainties, including the company’s ability to raise capital and the availability of funds and resources to pursue R&D projects, the recruitment of additional clinical trial sites, the rate of patient enrollment, the successful and timely completion of clinical studies, the success of Baxter’s commercialization efforts, the ability of Spectral to take advantage of business opportunities in the biomedical industry, the granting of necessary approvals by regulatory authorities as well as general economic, market and business conditions, and could differ materially from what is currently expected.
The TSX has not reviewed and does not accept responsibility for the adequacy or accuracy of this statement.
For further information, please contact:
Capital Markets & Investor Relations | US Investor Relations | CFO |
416-962-3300 | 212-671-1020 | 416-626-3233 |
am@spinnakercmi.com | edt@crescendo-ir.com | bmcinnis@spectraldx.com |
Condensed Interim Consolidated Statements of Financial Position
In CAD (000s), except for share and per share data
(Unaudited)
2023 | 2022 | |||
$ | $ | |||
Assets | ||||
Current assets | ||||
Cash | 5,031 | 8,414 | ||
Trade and other receivables | 720 | 1,056 | ||
Inventories | 304 | 340 | ||
Prepayments and other assets | 912 | 276 | ||
6,967 | 10,086 | |||
Non-current assets | ||||
Right-of-use-asset | 598 | 464 | ||
Property and equipment | 165 | 237 | ||
Intangible asset | 192 | 211 | ||
Investment in iDialco | 794 | 998 | ||
Total assets | 8,716 | 11,996 | ||
Liabilities | ||||
Current liabilities | ||||
Trade and other payables | 2,314 | 3,167 | ||
Current portion of contract liabilities | 757 | 696 | ||
Current portion of lease liability | 121 | 96 | ||
3,192 | 3,959 | |||
Non-current liability | ||||
Lease liability | 535 | 420 | ||
Non-current portion of contract liabilities | 3,509 | 4,011 | ||
Notes payable | 11,631 | 6,129 | ||
Total liabilities | 18,867 | 14,519 | ||
Shareholders’ deficiency | ||||
Share capital | 87,061 | 87,050 | ||
Contributed surplus | 8,916 | 8,773 | ||
Share-based compensation | 10,197 | 8,908 | ||
Warrants | 2,526 | 2,490 | ||
Deficit | (118,851 | ) | (109,744 | ) |
Total shareholders’ deficiency | (10,151 | ) | (2,523 | ) |
Total liabilities and shareholders’ deficiency | 8,716 | 11,996 |
Condensed Interim Consolidated Statements of Loss and Comprehensive Loss
In CAD (000s), except for share and per share data
(Unaudited)
Three- months ended September 30, 2023 | Three- months ended September 30, 2022 | Nine- months ended September 30, 2023 | Nine- months ended September 30, 2022 | ||||||
$ | $ | $ | $ | ||||||
Revenue | 397 | 362 | 1,233 | 1,114 | |||||
Expenses | |||||||||
Changes in inventories of finished goods and work-in-process | - | 71 | - | 160 | |||||
Raw materials and consumables used | 305 | 121 | 722 | 357 | |||||
Salaries and benefits | 987 | 891 | 2,918 | 2,555 | |||||
Consulting and professional fees | 1,198 | 933 | 3,300 | 2,060 | |||||
Regulatory and investor relations | 109 | 123 | 414 | 442 | |||||
Travel and entertainment | 63 | 78 | 245 | 197 | |||||
Facilities and communication | 81 | 81 | 245 | 218 | |||||
Insurance | 102 | 119 | 290 | 357 | |||||
Depreciation and amortization | 57 | 55 | 172 | 171 | |||||
Interest expense | 173 | 6 | 429 | 19 | |||||
Foreign exchange (gain) loss | 146 | 19 | (89 | ) | 30 | ||||
Share-based compensation | 340 | 217 | 1,300 | 1,005 | |||||
Other expense (income) | 56 | (9 | ) | 64 | 19 | ||||
Net Loss on joint arrangement | 41 | - | 205 | - | |||||
3,658 | 2,705 | 10,215 | 7,552 | ||||||
Loss and comprehensive loss for the year from continuing operations | (3,261 | ) | (2,343 | ) | (8,982 | ) | (6,438 | ) | |
Income (loss) from discontinued operations | (130 | ) | (792 | ) | (125 | ) | (2,340 | ) | |
Loss and comprehensive loss for the year | (3,391 | ) | (3,135 | ) | (9,107 | ) | (8,778 | ) | |
Basic and diluted loss from continuing operations per common share | (0.01 | ) | (0.00 | ) | (0.02 | ) | (0.01 | ) | |
Basic and diluted income (loss) from discontinued operations per common share | (0.00 | ) | (0.00 | ) | (0.00 | ) | (0.00 | ) | |
Basic and diluted loss per common share | (0.01 | ) | (0.01 | ) | (0.02 | ) | (0.02 | ) | |
Weighted average number of common shares outstanding – basic and diluted | 278,604,718 | 268,283,387 | 278,569,902 | 268,064,079 |
Condensed Interim Consolidated Statements of Changes in Shareholders’ Deficiency
In CAD (000s)
(Unaudited)
Number of shares | Share Capital | Contributed surplus | Share-based compensation | Warrants | Deficit | Total Shareholders’ (deficiency) | |||||||||
$ | $ | $ | $ | $ | $ | ||||||||||
Balance, | 267,886,408 | 84,357 | 7,985 | 7,984 | 2,251 | (98,494 | ) | 4,083 | |||||||
Share options exercised | 268,797 | 157 | - | (69 | ) | - | - | 88 | |||||||
RSUs released | 284,072 | 174 | - | (174 | ) | - | - | - | |||||||
Warrants expired | - | - | 788 | - | (788 | ) | - | - | |||||||
Loss and comprehensive loss for the period | - | - | - | - | - | (8,778 | ) | (8,778 | ) | ||||||
Share-based compensation | - | - | - | 1,005 | - | - | 1,005 | ||||||||
Balance, | 268,439,277 | 84,688 | 8,773 | 8,746 | 1,463 | (107,272 | ) | (3,602 | |||||||
Bought deal offering | 10,061,250 | 2,313 | - | - | 1,027 | - | 3,340 | ||||||||
RSU Released | 47,277 | 49 | - | (30 | ) | - | - | 19 | |||||||
Loss and comprehensive loss for the period | - | - | - | - | - | (2,472 | ) | (2,472 | |||||||
Share-based compensation | - | - | - | 192 | - | - | 192 | ||||||||
Balance, | 278,547,804 | 87,050 | 8,773 | 8,908 | 2,490 | (109,744 | ) | (2,523 |
Balance, | 278,547,804 | 87,050 | 8,773 | 8,908 | 2,490 | (109,744 | ) | (2,523 | ) | ||
RSUs released | 28,457 | 11 | - | (11 | ) | - | - | - | |||
Warrants issued | - | - | - | - | 179 | - | 179 | ||||
Warrants expired | - | - | 143 | - | (143 | ) | - | - | |||
Loss and comprehensive loss for the period | - | - | - | - | - | (9,107 | ) | (9,107 | ) | ||
Share-based compensation | - | - | - | 1,300 | - | - | 1,300 | ||||
Balance, | 278,576,261 | 87,061 | 8,916 | 10,197 | 2,526 | (118,851 | ) | (10,151 | ) |
Condensed Interim Consolidated Statements of Cash Flows
In CAD (000s)
(Unaudited)
Nine-months ended | Nine-months ended | |||
$ | $ | |||
Cash flow provided by (used in) | ||||
Operating activities | ||||
Loss and comprehensive loss for the period | (9,107 | ) | (8,778 | ) |
Adjustments for: | ||||
Depreciation on right-of-use asset | 73 | 71 | ||
Depreciation on property and equipment | 72 | 123 | ||
Amortization of intangible asset | 19 | 13 | ||
Amortization of deferred financing Fees | 147 | - | ||
Interest expense | 429 | 19 | ||
Unrealized foreign exchange gain | (38 | ) | (33 | ) |
Share-based compensation | 1,479 | 1,005 | ||
Write down of property and equipment to fair value | 91 | |||
Loss on investment in iDialco | 205 | - | ||
Changes in items of working capital: | ||||
Trade and other receivables | 336 | 129 | ||
Inventories | 36 | (367 | ) | |
Prepayments and other assets | (636 | ) | 77 | |
Trade and other payables | (1,253 | ) | 493 | |
Contract liabilities | (648 | ) | (485 | ) |
Net cash used in operating activities | (8,886 | ) | (7,642 | ) |
Investing activities | ||||
Property and equipment acquisitions | - | (90 | ) | |
Net cash used in investing activities | - | (90 | ) | |
Financing activities | ||||
Lease liability payments | 110 | (88 | ) | |
Note payable | 6,213 | |||
Financing charges paid | (820 | ) | ||
Share options exercised | - | 88 | ||
Net cash provided by financing activities | 5,503 | - | ||
Decrease in cash | (3,383 | ) | (7,732 | ) |
Effects of exchange rate changes on cash | - | 33 | ||
Cash, beginning of period | 8,414 | 8,890 | ||
Cash, end of period | 5,031 | 1,191 |
Source:
2023 GlobeNewswire, Inc., source