DiaMedica Therapeutics Provides a Business Update and Announces Second Quarter 2023 Financial Results
- Resumption of clinical trial and completion of safety cohort could positively impact stock price.
- $37.5M private placement provides funding for clinical and product development activities.
- Cash runway into 2026 provides financial stability.
- None.
Conference Call and Webcast August 15 at 8:00 am Eastern Time / 7:00 am Central Time
- Company Resumes ReMEDy2 Clinical Trial after Clinical Hold Lifted
-
Company Completed a
“At-The-Market” Private Placement, Cash Runway Into 2026$37.5M - Company Completed an Additional Safety Cohort of ACEi Patients in its Phase 1C Healthy Volunteer Study
Clinical Developments
Clinical Hold Lifted on ReMEDy2 Phase 2/3 Trial for Acute Ischemic Stroke
On June 21, 2023, the Company announced that the
“With the lifting of the clinical hold, we are thrilled to reengage with doctors and hospitals to work towards developing DM199 as a significant advance for the treatment of ischemic stroke patients,” commented Rick Pauls, DiaMedica’s Chief Executive Officer. “We look forward to keeping you updated on the progress of our trial.”
DiaMedica also completed an additional cohort of hypertensive patients (Part B) being treated with angiotensin-converting enzyme inhibitors (ACEi) in its Phase 1C open label, single ascending dose (SAD) study of DM199, administered with the polyvinylchloride (PVC) IV bags used in the ReMEDy2 trial. In the initial part of the study (Part A), DiaMedica confirmed in healthy volunteers that the revised IV dose of DM199, 0.5 µg/kg, was well-tolerated and achieved an appropriate DM199 blood concentration level in the desired therapeutic range, similar to prior clinical trials. In Part B, all ACEi patients received the full IV dose at the 0.5 µg/kg level with no instances of hypotension. DiaMedica believes that these results will provide further assurance to potential investigators that ACEi patients may be safely included in the ReMEDy2 trial. This Phase 1C study is now finished and the Company is completing final closing procedures.
“At-the-Market” Financing
As previously announced, DiaMedica completed a
DiaMedica expects to use the net proceeds from these sales to continue its clinical and product development activities for DM199 and for other working capital and general corporate purposes.
Balance Sheet and Cash Flow
DiaMedica reported total cash, cash equivalents and investments of
Net cash used in operating activities for the six months ended June 30, 2023 was
Financial Results
Research and development (R&D) expenses increased to
General and administrative (G&A) expenses were
Conference Call and Webcast Information
DiaMedica Management will host a conference call and webcast to discuss its business update and second quarter 2023 financial results on Tuesday, August 15, 2023, at 8:00 AM Eastern Time / 7:00 AM Central Time:
Date: |
Tuesday, August 15, 2023 |
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Time: |
7:00 AM CT / 8:00 AM ET |
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Web access: |
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Dial In: |
(877) 550-1858 |
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Conference ID: |
2125# |
Interested parties may access the conference call by dialing in or listening to the simultaneous webcast. Listeners should log on to the website or dial in 15 minutes prior to the call. The webcast will remain available for playback on the Company’s website, under investor relations - events and presentations, following the earnings call and for 12 months thereafter. A telephonic replay of the conference call will be available until August 22, 2023, by dialing (800) 645-7964 (US Toll Free) and entering the replay passcode: 2125#.
About ReMEDy2 Trial
The ReMEDy2 trial is an adaptive design, randomized, double-blind, placebo-controlled trial studying the use of the Company’s product candidate, DM199, to treat acute ischemic stroke (AIS) patients. The trial is intended to enroll approximately 350 patients at up to 75 sites in
About DM199
DM199 is a recombinant (synthetic) form of human tissue kallikrein-1 (KLK1). KLK1 is a serine protease (protein) that plays an important role in the regulation of diverse physiological processes including blood flow, inflammation, fibrosis, oxidative stress and neurogenesis via a molecular mechanism that increases production of nitric oxide and prostaglandin. KLK1 deficiency may play a role in multiple vascular and fibrotic diseases such as stroke, chronic kidney disease, retinopathy, vascular dementia, and resistant hypertension where current treatment options are limited or ineffective. DiaMedica is the first company to have developed and clinically studied a recombinant form of the KLK1 protein. The KLK1 protein, produced from the pancreas of pigs and human urine, has been used to treat patients in
About DiaMedica Therapeutics Inc.
DiaMedica Therapeutics Inc. is a clinical stage biopharmaceutical company committed to improving the lives of people suffering from serious diseases with a focus on acute ischemic stroke. DiaMedica’s lead candidate DM199 is the first pharmaceutically active recombinant (synthetic) form of the KLK1 protein, an established therapeutic modality in
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the
DiaMedica Therapeutics Inc. |
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Condensed Consolidated Statements of Operations and Comprehensive Loss |
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(In thousands, except share and per share amounts) |
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(Unaudited) |
|||||||||||||||
|
Three Months Ended
|
|
Six Months Ended
|
||||||||||||
|
2023 |
|
2022 |
|
2023 |
|
2022 |
||||||||
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
||||
Research and development |
$ |
2,543 |
|
|
$ |
1,955 |
|
|
$ |
6,161 |
|
|
$ |
3,929 |
|
General and administrative |
|
2,198 |
|
|
|
1,409 |
|
|
|
4,101 |
|
|
|
2,971 |
|
Operating loss |
|
(4,741 |
) |
|
|
(3,364 |
) |
|
|
(10,262 |
) |
|
|
(6,900 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Other income: |
|
|
|
|
|
|
|
|
|
|
|
||||
Other income, net |
|
271 |
|
|
|
13 |
|
|
|
527 |
|
|
|
48 |
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Loss before income tax expense |
|
(4,470 |
) |
|
|
(3,351 |
) |
|
|
(9,735 |
) |
|
|
(6,852 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Income tax expense |
|
(7 |
) |
|
|
(7 |
) |
|
|
(14 |
) |
|
|
(14 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Net loss |
|
(4,477 |
) |
|
|
(3,358 |
) |
|
|
(9,749 |
) |
|
|
(6,866 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Other comprehensive income (loss) |
|
|
|
|
|
|
|
|
|
|
|
||||
Unrealized gain (loss) on marketable securities |
|
(34 |
) |
|
|
(60 |
) |
|
|
11 |
|
|
|
(116 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Net loss and comprehensive loss |
$ |
(4,511 |
) |
|
$ |
(3,418 |
) |
|
$ |
(9,738 |
) |
|
$ |
(6,982 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Basic and diluted net loss per share |
$ |
(0.16 |
) |
|
$ |
(0.13 |
) |
|
$ |
(0.36 |
) |
|
$ |
(0.26 |
) |
Weighted average shares outstanding – basic and diluted |
|
27,312,008 |
|
|
|
26,443,067 |
|
|
|
26,882,858 |
|
|
|
26,443,067 |
|
DiaMedica Therapeutics Inc. |
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Condensed Consolidated Balance Sheets |
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(In thousands, except share amounts) |
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|
|
June 30, 2023 |
|
December 31, 2022 |
||||
|
|
(unaudited) |
|
|
|
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ASSETS |
|
|
|
|
|
|
||
Current assets: |
|
|
|
|
|
|
||
Cash and cash equivalents |
|
$ |
5,839 |
|
|
$ |
4,728 |
|
Short term marketable securities |
|
|
34,529 |
|
|
|
28,774 |
|
Prepaid expenses and other assets |
|
|
675 |
|
|
|
251 |
|
Amounts receivable |
|
|
188 |
|
|
|
82 |
|
Total current assets |
|
|
41,231 |
|
|
|
33,835 |
|
|
|
|
|
|
|
|
||
Non-current assets: |
|
|
|
|
|
|
||
Long term marketable securities |
|
|
20,296 |
|
|
|
|
|
Operating lease right-of-use asset, net |
|
|
390 |
|
|
|
424 |
|
Property and equipment, net |
|
|
133 |
|
|
|
136 |
|
Total non-current assets |
|
|
20,819 |
|
|
|
560 |
|
|
|
|
|
|
|
|
||
Total assets |
|
$ |
62,050 |
|
|
$ |
34,395 |
|
|
|
|
|
|
|
|
||
LIABILITIES AND EQUITY |
|
|
|
|
|
|
||
Current liabilities: |
|
|
|
|
|
|
||
Accounts payable |
|
$ |
856 |
|
|
$ |
734 |
|
Accrued liabilities |
|
|
1,011 |
|
|
|
1,365 |
|
Operating lease obligation |
|
|
76 |
|
|
|
63 |
|
Finance lease obligation |
|
|
3 |
|
|
|
6 |
|
Total current liabilities |
|
|
1,946 |
|
|
|
2,168 |
|
|
|
|
|
|
|
|
||
Non-current liabilities: |
|
|
|
|
|
|
||
Operating lease obligation, non-current |
|
|
357 |
|
|
|
396 |
|
Finance lease obligation, non-current |
|
|
4 |
|
|
|
4 |
|
Total non-current liabilities |
|
|
361 |
|
|
|
400 |
|
|
|
|
|
|
|
|
||
Shareholders’ equity: |
|
|
|
|
|
|
||
Common shares, no par value; unlimited authorized; 26,464,977 and 26,443,067 shares issued and outstanding as of March 31, 2023 and December 31, 2022, respectively |
|
|
— |
|
|
|
— |
|
Paid-in capital |
|
|
165,732 |
|
|
|
128,078 |
|
Accumulated other comprehensive loss |
|
|
(63 |
) |
|
|
(74 |
) |
Accumulated deficit |
|
|
(105,926 |
) |
|
|
(96,177 |
) |
Total shareholders’ equity |
|
|
59,743 |
|
|
|
31,827 |
|
Total liabilities and shareholders’ equity |
|
$ |
62,050 |
|
|
$ |
34,395 |
|
|
|
|
|
|
|
|
DiaMedica Therapeutics Inc. |
||||||||
Condensed Consolidated Statements of Cash Flows |
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(In thousands) |
||||||||
(Unaudited) |
||||||||
Six Months Ended June 30, |
||||||||
2023 |
2022 |
|||||||
Cash flows from operating activities: |
|
|
|
|
|
|
||
Net loss |
|
$ |
(9,749 |
) |
|
$ |
(6,866 |
) |
Adjustments to reconcile net loss to net cash used in operating activities: |
|
|
|
|
|
|
||
Share-based compensation |
|
|
802 |
|
|
|
673 |
|
Amortization of discount on marketable securities |
|
|
(432 |
) |
|
|
160 |
|
Non-cash lease expense |
|
|
34 |
|
|
|
31 |
|
Depreciation |
|
|
14 |
|
|
|
12 |
|
Changes in operating assets and liabilities: |
|
|
|
|
|
|
||
Amounts receivable |
|
|
(106 |
) |
|
|
42 |
|
Prepaid expenses and other assets |
|
|
(424 |
) |
|
|
(445 |
) |
Accounts payable |
|
|
122 |
|
|
|
115 |
|
Accrued liabilities |
|
|
(380 |
) |
|
|
(106 |
) |
Net cash used in operating activities |
|
|
(10,119 |
) |
|
|
(6,384 |
) |
|
|
|
|
|
|
|
||
Cash flows from investing activities: |
|
|
|
|
|
|
||
Purchase of marketable securities |
|
|
(52,743 |
) |
|
|
(27,510 |
) |
Maturities of marketable securities |
|
|
27,135 |
|
|
|
32,258 |
|
Purchases of property and equipment |
|
|
(11 |
) |
|
|
(6 |
) |
Net cash (used in) provided by investing activities |
|
|
(25,619 |
) |
|
|
4,742 |
|
|
|
|
|
|
|
|
||
Cash flows from financing activities: |
|
|
|
|
|
|
||
Proceeds from issuance of common shares, net of offering costs |
|
|
36,852 |
|
|
|
— |
|
Principal payments on finance lease obligations |
|
|
(3 |
) |
|
|
(3 |
) |
Net cash provided by (used in) financing activities |
|
|
36,849 |
|
|
|
(3 |
) |
|
|
|
|
|
|
|
||
Net increase (decrease) in cash and cash equivalents |
|
|
1,111 |
|
|
|
(1,645 |
) |
Cash and cash equivalents at beginning of period |
|
|
4,728 |
|
|
|
4,707 |
|
Cash and cash equivalents at end of period |
|
$ |
5,839 |
|
|
$ |
3,062 |
|
|
|
|
|
|
|
|
||
Supplemental disclosure of non-cash transactions: |
|
|
|
|
|
|
||
Assets acquired under financing lease |
|
$ |
— |
|
|
$ |
10 |
|
Cash paid for income taxes |
|
$ |
20 |
|
|
$ |
8 |
|
View source version on businesswire.com: https://www.businesswire.com/news/home/20230814548974/en/
Scott Kellen
Chief Financial Officer
Phone: (763) 496-5118
skellen@diamedica.com
Paul Papi
Corporate Communications
Phone: (508) 444-6790
ppapi@diamedica.com
Source: DiaMedica Therapeutics Inc.