The Company made significant progress throughout 2023, both clinically and operationally. Specifically, regarding its Tigris trial, a Phase III clinical trial evaluating PMX for endotoxic septic shock. The Company has successfully enrolled 97 patients to date, out of the 150 total patients to be enrolled, and focused on the final push to fully enroll and finish the Tigris trial. The Company believes that the continued onboarding of new Tigris sites since the fourth quarter of 2023 could further accelerate enrollment experienced to date and allow Spectral to rapidly reach the 150-patient target, bringing the Company closer to FDA submission and potential FDA approval. In parallel to its clinical trial, the Company continues to work closely with its commercialization partner,
Dr.
Corporate Highlights During & Subsequent to the Fourth Quarter and Fiscal Year Ended
Tigris:
- Total of 97 patients randomized to date out of the 150 total patients to be enrolled in the Tigris trial.
- accelerated enrollment experienced in 2024 to date, with 16 patients enrolled so far – represents the most robust enrollment rates since the start of the Tigris trial.
- Currently 22 Tigris sites onboarded
- addition of two new trial sites in the fourth quarter – the
Mayo Clinic andEmory Healthcare . - subsequent to the fourth quarter, the Company added three new sites –
University of Texas Health Sciences Center atHouston ,The Institute for Extracorporeal Life Support (San Antonio, TX ), andUCLA , with two additional sites in the pipeline.
- addition of two new trial sites in the fourth quarter – the
- Investigator Meeting held
March 12 th and 13th- The Company held a Tigris trial Investigator Meeting in conjunction with the 29th
International Conference on Advances in Critical Care Nephrology in San Diego. - In-person meeting well attended with multiple stakeholders present, including: principal investigators and clinical research coordinators from existing and new trial sites; CRO, Beaufort; and representatives from the Company’s strategic partner
Baxter . - Focus of the meeting was on the practical aspects of diagnosing endotoxic septic shock and treating with PMX, as well as featuring several talks from trial sites on how EAA and PMX could be implemented into routine clinical practice after potential regulatory approval of PMX.
- The Company held a Tigris trial Investigator Meeting in conjunction with the 29th
- Completion of EDEN Observational Study
- The Company completed its EDEN study in the fourth quarter with 92 patients enrolled. The ancillary observational study collected data on patients with sepsis even if ineligible for Tigris, and captured much needed data on the full range of septic shock and its relation to organ failure and endotoxin activity. These data will inform subsequent discussions with the FDA on labelling for PMX, as well as to provide the medical community and the Company a better picture of the addressable population in the
U.S. for PMX. The Company expects final analysis of the data in mid-2024.
- The Company completed its EDEN study in the fourth quarter with 92 patients enrolled. The ancillary observational study collected data on patients with sepsis even if ineligible for Tigris, and captured much needed data on the full range of septic shock and its relation to organ failure and endotoxin activity. These data will inform subsequent discussions with the FDA on labelling for PMX, as well as to provide the medical community and the Company a better picture of the addressable population in the
PMX Commercialization:
- 90 patient enrollment interim milestone achieved
- On
February 15, 2024 , Spectral announced that it had reached the 90-patient enrollment threshold and provided written notification toBaxter of this achievement. Subsequently,Baxter exercised its option to maintain exclusive distribution rights and paid Spectral an~C$2 million non-dilutive payment. - Since inception of partnership, funding support from
Baxter has amounted to~C$15 million – comprised of non-dilutive payments and convertible notes subscriptions.
- On
- Amendment of Initial Term of Exclusive Distribution Agreement
- In
February 2024 , the Company andBaxter mutually agreed to amend the initial term of the exclusive distribution agreement to 10 years post-FDA approval; the Company believes the 10-year term provides mutually beneficial runway to maximize PMX commercial economics.
- In
- Commercialization Activities
- In anticipation of a positive Tigris trial outcome, the Company has been working closely with
Baxter on post-approval marketing plans for PMX commercialization. This includes developing product branding, pricing and roll-out plans with numerousBaxter departments, including marketing, regulatory, clinical and reimbursement.Baxter has communicated its intention to undertake a broad marketing campaign on day one of FDA approval for PMX. - The Company is also working with
Baxter on a sub-study to obtain FDA clearance for hemoperfusion for Baxter’s Prismax device. The Prismax, with its leading installed base in ICUs throughout theU.S. , is anticipated to be the primary ICU device utilized for PMX treatments on commercial launch.
- In anticipation of a positive Tigris trial outcome, the Company has been working closely with
i-
Throughout 2023, the Company became aware of significant changes in the iDialco business plan that impacted the ability of the Company to forecast the recoverability of the investment. Accordingly, the net investment was assessed for a non-cash impairment loss. As part of this assessment the Company noted significant changes from the initial business plan at inception, including the identification that the period of negative cash flows for the entity increased substantially as a result of shift in both the regulatory and commercialization timelines mainly due to further device developments and improvements required for clinical adoption of the SAMI and DIMI devices. The Company maintains a 30% ownership and voting rights within iDialco, and will continue to track any future losses or gains booked by iDialco.
“I am pleased with the increased level of activity across the Company and its impact on establishing robust trial sites, thus resulting in a significant ramp up of patient enrollment. The recent pace of enrollment, combined with the quality and focus of the current and planned trial sites provide us with confidence in continued robust enrollment activity. The potential to sustain our current pace of enrollment could see us rapidly advance the trial towards completion in the late 2024 to early 2025 timeframe,” said
Financial Review
Revenue for the three-months ended
For the quarter ended
Loss for the three-months ended
The Company concluded the 2023 year 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
The Tigris Trial is a confirmatory study of PMX in addition to standard care vs standard care alone and is designed as a 2:1 randomized trial of 150 patients using Bayesian statistics. Endotoxic septic shock is a malignant form of sepsis https://www.youtube.com/watch?v=6RANrHHi9L8.
The trial methods are detailed in “Bayesian methods: a potential path forward for sepsis trials”.
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 availability of funds and resources to pursue R&D projects, the successful and timely completion of clinical studies, 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 | CEO | |
416-962-3300 | ||
am@spinnakercmi.com | cseto@spectraldx.com |
Consolidated Statements of Financial Position | |||||
(in thousands of Canadian dollars) | |||||
Notes | Dec-31 | Revised (Refer note 15) Dec-31 | |||
2023 | 2022 | ||||
$ | $ | ||||
Assets | |||||
Current assets | |||||
Cash | 5 | 2,952 | 8,414 | ||
Trade and other receivables | 6 | 186 | 1,056 | ||
Inventories | 7 | 366 | 340 | ||
Prepayments and other assets | 8 | 621 | 276 | ||
4,125 | 10,086 | ||||
Non-current assets | |||||
Right-of-use-asset | 9 | 567 | 464 | ||
Property and equipment | 10 | 326 | 237 | ||
Intangible asset | 11 | 193 | 211 | ||
Investment in iDialco | 12 | - | 998 | ||
Total assets | 5,211 | 11,996 | |||
Liabilities | |||||
Current liabilities | |||||
Trade and other payables | 13 | 2,820 | 3,087 | ||
Current portion of contract liabilities | 14 | 727 | 696 | ||
Current portion of lease liability | 9 | 121 | 96 | ||
Notes Payable | 15 | 264 | 79 | ||
Derivative Liabilities | 15 | 6,310 | 2,674 | ||
10,242 | 6,632 | ||||
Non-current liability | |||||
Lease liability | 9 | 500 | 420 | ||
Non-current portion of contract liabilities | 14 | 3,342 | 4,011 | ||
Notes payable | 15 | 7,676 | 3,487 | ||
Total liabilities | 21,760 | 14,550 | |||
Shareholders' (deficiency) equity | 17 | ||||
Share capital | 87,061 | 87,050 | |||
Contributed surplus | 8,916 | 8,773 | |||
Share-based compensation | 10,385 | 8,908 | |||
Warrants | 2,526 | 2,490 | |||
Deficit | (125,437 | ) | (109,775 | ) | |
Total shareholders' (deficiency) equity | (16,549 | ) | (2,554 | ) | |
Total liabilities and shareholders' (deficiency) equity | 5,211 | 11,996 |
Consolidated Statements of Loss and Comprehensive Loss For the years ended | |||||
(in thousands of Canadian dollars, except for share and per share data) | |||||
Notes | 2023 | Revised (Refer note 15) 2022 | |||
$ | $ | ||||
Revenue | 20 | 1,598 | 1,667 | ||
Expenses | |||||
Raw materials and consumables used | 936 | 684 | |||
Salaries and benefits | 22 | 3,857 | 3,767 | ||
Consulting and professional fees | 4,825 | 2,653 | |||
Regulatory and investor relations | 581 | 567 | |||
Travel and entertainment | 297 | 247 | |||
Facilities and communication | 414 | 297 | |||
Insurance | 411 | 477 | |||
Depreciation and amortization | 210 | 225 | |||
Interest expense | 9,15 | 1,334 | 176 | ||
Foreign exchange (gain) and loss | (126 | ) | 39 | ||
Share-based compensation | 17 | 1,488 | 1,197 | ||
Other expense | 315 | 290 | |||
Net (gain) loss on joint venture arrangement | 12 | 398 | (998 | ) | |
Impairment loss on joint venture arrangement | 12 | 600 | - | ||
Fair Value Adjustment Derivative Liabilities | 1,565 | (326 | ) | ||
17,105 | 9,295 | ||||
Loss and comprehensive loss for the year from continuing operations | (15,507 | ) | (7,628 | ) | |
Loss from discontinued operations | 4 | (155 | ) | (3,653 | ) |
Loss and comprehensive loss for the year | (15,662 | ) | (11,281 | ) | |
Basic and diluted loss from continuing operations per common share | 18 | (0.06 | ) | (0.03 | ) |
Basic and diluted loss from discontinued operations per common share | 18 | 0.00 | (0.01 | ) | |
Basic and diluted loss per common share | 18 | (0.06 | ) | (0.04 | ) |
Weighted average number of common shares outstanding - basic and diluted | 18 | 278,563,241 | 269,843,447 |
Consolidated Statements of Changes in Shareholders’ (Deficiency) Equity | ||||||||||||
For the years ended | ||||||||||||
(in thousands of Canadian dollars) | ||||||||||||
Notes | Issued capital | Contributed surplus | Share-based compensation | Warrants | Deficit | Total Shareholders’ (deficiency) equity | ||||||
Number | $ | $ | $ | $ | $ | $ | ||||||
Balance, | 267,886,408 | 84,357 | 7,985 | 7,984 | 2,251 | (98,494 | ) | 4,083 | ||||
Bought deal offering | 21 | 10,061,250 | 2,313 | - | - | 1,027 | - | 3,340 | ||||
Share options exercised | 15 | 268,797 | 157 | (69 | ) | - | - | 88 | ||||
RSU released | 331,349 | 223 | - | (204 | ) | - | - | 19 | ||||
Warrants expired | - | - | 788 | - | (788 | ) | - | - | ||||
Loss and comprehensive loss for the year | - | - | - | - | - | (11,281 | ) | (11,281 | ) | |||
Share-based compensation | 15 | - | - | - | 1,197 | - | - | 1,197 | ||||
Revised (Refer note 15) Balance, | 278,547,804 | 87,050 | 8,773 | 8,908 | 2,490 | (109,775 | ) | (2,554 | ) | |||
RSU released | 28,457 | 11 | - | (11 | ) | - | - | |||||
Warrants expired | - | - | 143 | - | (143 | ) | - | - | ||||
Warrants issued | 179 | 179 | ||||||||||
Loss and comprehensive loss for the year | - | - | - | - | - | (15,662 | ) | (15,662 | ) | |||
Share-based compensation | 15 | - | - | - | 1,488 | - | - | 1,488 | ||||
Balance | 278,576,261 | 87,061 | 8,916 | 10,385 | 2,526 | (125,437 | ) | (16,549 | ) |
Consolidated Statements of Cash Flows | |||||
For the years ended | |||||
(in thousands of Canadian dollars) | |||||
Notes | 2023 | Revised (Refer note 15) 2022 | |||
$ | $ | ||||
Cash flow provided by (used in) | |||||
Operating activities | |||||
Loss for the year | (15,662 | ) | (11,281 | ) | |
Adjustments for: | |||||
Depreciation on right-of-use asset | 9 | 104 | 94 | ||
Depreciation on property and equipment | 10 | 96 | 161 | ||
Amortization of intangible asset | 11 | 18 | 17 | ||
Amortization and Derivative related financing fees | 446 | 324 | |||
Unrealized foreign exchange (gain) and loss | (228 | ) | (10 | ) | |
Interest expense on lease liability | 9 | 25 | 25 | ||
Accreted Interest on Notes Payable | 835 | 151 | |||
Share-based compensation | 17 | 1,488 | 1,197 | ||
Disposal of property and equipment | - | 167 | |||
Net (gain) loss on joint venture arrangement | 12 | 398 | (998 | ) | |
Impairment loss on joint venture arrangement | 12 | 600 | |||
Fair Value Adjustment derivative liabilities | 1,565 | (326 | ) | ||
Changes in items of working capital: | |||||
Trade and other receivables | 870 | (851 | ) | ||
Inventories | (26 | ) | (47 | ) | |
Prepayments and other assets | (345 | ) | 599 | ||
Right-of-use-asset | - | (26 | ) | ||
Trade and other payables | (267 | ) | 1,565 | ||
Contract liabilities | (638 | ) | (661 | ) | |
Net cash used in operating activities | (10,721 | ) | (9,900 | ) | |
Investing activities | |||||
Purchases of property and equipment | 10 | (185 | ) | (33 | ) |
Net cash used in investing activities | (185 | ) | (33 | ) | |
Financing activities | |||||
Proceeds from bought deal offering | 23 | - | 4,025 | ||
Financing charges paid | 15,23 | (641 | ) | (1,363 | ) |
Note payable | 15 | 4,058 | 3,802 | ||
Lease liability payments | (127 | ) | (91 | ) | |
Share options exercised | - | 88 | |||
Derivative liabilities | 15 | 2,154 | 2,996 | ||
Net cash provided by financing activities | 5,444 | 9,457 | |||
Increase (decrease) in cash | (5,462 | ) | (476 | ) | |
Cash, beginning of year | 8,414 | 8,890 | |||
Cash, end of year | 2,952 | 8,414 |
Source:
2024 GlobeNewswire, Inc., source