Press Release: Spectral Announces Third Quarter -2-
Press Release: Spectral Announces Third Quarter -2-
About Spectral
關於光譜
Spectral is a Phase 3 company seeking U.S. FDA approval for its unique product for the treatment of patients with septic shock, Toraymyxin(TM) ("PMX"). PMX is a therapeutic hemoperfusion device that removes endotoxin, which can cause sepsis, from the bloodstream and is guided by the Company's Endotoxin Activity Assay (EAA(TM)), the only FDA cleared diagnostic for the risk of developing sepsis.
SPECTRUM是一家第三階段的公司，正在尋求美國食品和藥物管理局(FDA)批准其治療感染性休克患者的獨特產品Toraymyxin(TM)(“PMX”)。PMX是一種治療性血液灌流設備，可以從血液中去除可能導致膿毒症的內毒素，並由該公司的內毒素活性分析(EAA(TM))指導。EAA(TM)是FDA唯一通過的膿毒症風險診斷。
PMX is approved for therapeutic use in Japan and Europe, and has been used safely and effectively on more than 300,000 patients to date. In March 2009, Spectral obtained the exclusive development and commercial rights in the U.S. for PMX, and in November 2010, signed an exclusive distribution agreement for this product in Canada. Approximately 330,000 patients are diagnosed with severe sepsis and septic shock in North America each year.
PMX在日本和歐洲被批准用於治療，迄今已在30多萬名患者身上安全有效地使用。2009年3月，Spectral獲得了PMX在美國的獨家開發權和商業權，並於2010年11月在加拿大簽署了該產品的獨家分銷協議。北美每年約有33萬名患者被診斷為嚴重膿毒症和感染性休克。
Spectral, through its wholly owned subsidiary, Dialco Medical Inc., is also commercializing a new set of proprietary platforms addressing renal replacement therapy (RRT) across the dialysis spectrum. SAMI is targeting the acute RRT market, while DIMI is targeting the chronic RRT market. Dialco is currently pursuing regulatory approval for U.S. in-home use of DIMI, which is based on the same RRT platform as SAMI, but will be intended for home hemodialysis use. DIMI recently received its FDA 510k clearance for use in hospital and clinical settings, and obtained its Health Canada license for use within Canadian hospitals, clinics and in home.
SPECTRUM公司還通過其全資子公司Dialco Medical Inc.將一套新的專有平臺商業化，以解決透析範圍內的腎臟替代療法(RRT)問題。薩米的目標是急性RRT市場，而DIMI的目標是慢性RRT市場。Dialco目前正在尋求監管部門批准美國家庭使用DIMI，DIMI基於與SAMI相同的RRT平臺，但將用於家庭血液透析。DIMI最近獲得了FDA 510k的許可，可以在醫院和臨牀環境中使用，並獲得了加拿大衞生部的許可證，可以在加拿大的醫院、診所和家庭使用。
Spectral is listed on the Toronto Stock Exchange under the symbol EDT. For more information, please visit www.spectraldx.com.
SPECTRUM公司在多倫多證券交易所上市，代碼為EDT。欲瞭解更多信息，請訪問www.spectraldx.com。
Forward-looking statement
前瞻性陳述
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.
本新聞稿中非當前或歷史事實信息的信息可能構成證券法意義上的前瞻性信息。這些信息，特別是關於Spectral的未來前景和預期的事件或結果，隱含着基於Spectral高級管理層的信念以及目前掌握的信息的假設。雖然這些假設在準備時被Spectral認為是合理的，但它們可能被證明是不正確的。讀者請注意，實際結果受許多風險和不確定因素的影響，包括用於實施研發項目的資金和資源的可用性、臨牀研究的成功和及時完成、Spectral利用生物醫藥行業商機的能力、監管機構給予必要的批准以及總體經濟、市場和商業條件，可能與目前預期的大不相同。
The TSX has not reviewed and does not accept responsibility for the adequacy or accuracy of this statement.
多倫多證券交易所沒有對這一陳述的充分性或準確性進行審查，也不承擔任何責任。
For further information, please contact:
如需更多信息，請聯繫：
David Waldman/Natalya
Chris Seto Ali Mahdavi Rudman
Capital Markets &
CEO Investor Relations US Investor Relations
Spinnaker Capital Markets Crescendo Communications,
Spectral Medical Inc. Inc. LLC
416-626-3233 ext. 2004 416-962-3300 212-671-1020
cseto@spectraldx.com am@spinnakercmi.com edt@crescendo-ir.com
--------------------------
Spectral Medical Inc.
Condensed Interim Consolidated
Statements of Financial Position
(unaudited)
-------------------------------------- ------------- ------------
(in thousands of Canadian dollars)
September 30, December 31,
2021 2020
$ $
-------------------------------------- ------------- ------------
Assets
Current assets
Cash 10,923 5,807
Trade and other receivables 567 260
Inventories 399 348
Prepayments and other assets 792 389
12,681 6,804
Non-current assets
Right-of-use-asset 555 625
Property and equipment 538 488
Intangible asset 233 246
Total assets 14,007 8,163
--------------------------------------- ------------- ------------
Liabilities
Current liabilities
Trade and other payables 1,335 2,141
Current portion of contract liabilities 729 676
Current portion of lease liability 91 85
--------------------------------------- ------------- ------------
2,155 2,902
Non-current liability
Lease liability 513 582
Non-current portion of contract
liabilities 4,846 5,348
--------------------------------------- ------------- ------------
Total liabilities 7,514 8,832
Shareholders' equity (deficiency)
Share capital 84,357 71,870
Contributed surplus 7,985 7,981
Share-based compensation 7,842 6,771
Warrants 2,251 2,418
Deficit (95,942) (89,709)
--------------------------------------- ------------- ------------
Total shareholders' equity (deficiency) 6,493 (669)
Total liabilities and shareholders'
equity (deficiency) 14,007 8,163
--------------------------------------- ------------- ------------
Spectral Medical
Inc.
Condensed
Interim
Consolidated
Statements of
Loss and
Comprehensive
Loss
(unaudited)
---------------- -------------------------- ----------------------------
(in thousands of
Canadian
dollars, except
for share and
per share data)
Three-months ended Nine-months ended
September 30, September 30,
2021 2020 2021 2020
$ $ $ $
---------------- ----------- ----------- ----------- -----------
Revenue 230 418 1,535 1,566
Expenses
Changes in
inventories of
finished goods
and
work-in-process 26 72 198 84
Raw materials
and consumables
used 108 47 273 351
Salaries and
benefits 826 1,014 3,640 3,505
Consulting and
professional
fees 913 418 2,075 3,612
Regulatory and
investor
relations 128 87 402 318
Travel and
entertainment 118 6 178 109
Facilities and
communication 50 95 196 262
Insurance 98 62 292 186
Depreciation and
amortization 71 79 223 223
Interest expense
on lease
liability 7 8 21 25
Foreign exchange
loss (gain) (57) 110 37 (144)
Other expense
(income) 9 (3) 99 (6)
Write down of
property and
equipment to
fair value - - 174 -
Gain on disposal
of property and
equipment - - (40) (8)
2,297 1,995 7,768 8,517
Loss and
comprehensive
loss for the
period (2,067) (1,577) (6,233) (6,951)
---------------- ----------- ----------- ----------- -----------
Basic and
diluted loss
per common
share (0.008) (0.007) (0.025) (0.030)
---------------- ----------- ----------- ----------- -----------
Weighted average
number of
common shares
outstanding --
basic and
diluted 260,928,039 236,605,745 247,267,326 231,109,027
---------------- ----------- ----------- ----------- -----------
Spectral
Medical Inc.
Condensed Interim Consolidated Statements of Changes
in Shareholders' (Deficiency) Equity
(unaudited)
-------------- -------------------- ----------- ------------- --------- -------- -------------
(in thousands of Canadian dollars)
Total
Shareholders'
Contributed Share-based (deficiency)
Issued capital surplus compensation Warrants Deficit equity
Number $ $ $ $ $ $
-------------- ----------- ------ ----------- ------------ -------- ------- -------------
Balance,
January 1,
2020 225,876,683 66,837 7,981 6,183 1,870 (80,611) 2,260
Public
offering 8,500,000 3,526 - - 788 - 4,316
Share options
大衞·沃爾德曼/娜塔莉亞克里斯·西藤阿里巴巴-SW馬哈達維·魯德曼資本市場和CEO投資者關係美國投資者關係Spinnaker Capital Markets Crescendo Communications，SPECTRUM醫療公司有限責任公司416-626-3233分機2004年416-962-3300 212-671-1020電子郵件：cseto@spectraldx.com am@spinnakercmi.com edt@crescendo-ir.com -------------------------- 斯派克醫療公司。壓縮臨時合併財務狀況表(未經審計)-------------------------------------- ------------- ------------ (單位：千加元)九月三十日，十二月三十一日， 2021 2020 $ $ -------------------------------------- ------------- ------------ 資產流動資產現金10,923,807貿易和其他應收款567 260庫存399 348預付款和其他資產792 389 12,681 6,804 非流動資產使用權--資產555625物業和設備538 488無形資產233 246總資產14,007,8163--------------------------------------- ------------- ------------ 負債流動負債貿易和其他應付款1,335 2,141合同負債的當前部分729 676租賃負債的當前部分91 85--------------------------------------- ------------- ------------ 2,155 2,902 非流動負債租賃責任513 582合同的非當前部分負債4,846,5348--------------------------------------- ------------- ------------ 總負債7,514,832股東權益(不足)股本84,357，71,870繳款盈餘7,985 7,981以股份為基礎的薪酬7,842,7712,251,418份認股權證赤字(95,942)(89,709)--------------------------------------- ------------- ------------ 股東權益總額(不足)6493(669)總負債和股東權益權益(不足)14,007 8,163--------------------------------------- ------------- ------------ 光譜醫療Inc.凝縮臨時整合的聲明損失和全面損失(未經審計)---------------- -------------------------- ---------------------------- (在數以千計的加拿大人美元，除了對於共享和每股數據)截至三個月止九個月止九月三十號，九月三十號， 2021 2020 2021 2020 $ $ $ $ ---------------- ----------- ----------- ----------- ----------- 收入230 418 1,535 1,566費用中的更改庫存：成品和在製品26 72 198 84原料和消耗品二手108 47 273 351工資和福利826 1,014 3,640 3,505諮詢和專業人士費用913 418 2,075 3,612監管和投資者關係128 87 402 318旅行和娛樂業118 6 178 109設施和通訊50 95 196 262保險業98 62 292 186折舊和折舊攤銷71 79 223 223利息支出租賃負債7 8 21 25外匯虧損(收益)(57)110 37(144)其他費用(收入)9(3)99(6)寫下……屬性和要安裝的設備公允價值--174-處置收益財產和財產設備--(40)(8) 2,297 1,995 7,768 8,517 損失和全面損失的原因是期間(2,067)(1,577)(6,233)(6,951)---------------- ----------- ----------- ----------- ----------- 基本和稀釋損失按公用事業單位份額(0.008)(0.007)(0.025)(0.030)---------------- ----------- ----------- ----------- ----------- 加權平均數量普通股傑出的--基本和稀釋260,928,039 236,605,745 247,267,326 231,109,027---------------- ----------- ----------- ----------- ----------- 光譜醫療公司簡明中期綜合變動表在股東(不足)權益中(未經審計)-------------- -------------------- ----------- ------------- --------- -------- ------------- (單位：千加元)總計股東的以出資股份為基礎(不足)已發行資本盈餘補償認股權證虧損權益數字$-------------- ----------- ------ ----------- ------------ -------- ------- ------------- 平衡，1月1日， 2020 225,876,683 66,837 7,981 6,183 1,870 (80,611) 2,260 公眾報價8,500,000 3,526--788-4,316股票期權
譯文內容由第三人軟體翻譯。