On May 5, 2022 Prothena Corporation plc (NASDAQ:PRTA), a late-stage clinical biotechnology company with a robust pipeline of investigational therapeutics built on protein dysregulation expertise, reported financial results for the first quarter 2022 (Press release, Prothena, MAY 5, 2022, View Source [SID1234613796]).

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"We are excited to kick off 2022 with a strong first quarter, further reinforcing continued execution across our portfolio. We remain focused on the Phase 3 AFFIRM-AL trial of birtamimab being conducted under a SPA agreement with FDA. We also achieved multiple milestones in our PRX012 program, our next-generation, subcutaneous anti-amyloid beta antibody, having received FDA clearance of the IND, initiated a Phase 1 clinical study and received Fast Track designation from FDA. Additionally, we presented positive preclinical findings for our Alzheimer’s and Parkinson’s active vaccine candidates at AD/PD 2022, further highlighting the depth of our neurodegenerative pipeline," said Gene Kinney, Ph.D., President and Chief Executive Officer of Prothena. "Later this year, we look forward to clinical data from our PRX005 Phase 1 study and the initiation of a Phase 1 multiple ascending dose study for PRX012. We will continue to drive meaningful growth this year across our portfolio and our strong capital position supports our leadership in protein dysregulation."

First Quarter and Recent Business Highlights and Upcoming Milestones

Neurodegenerative Diseases Portfolio

Alzheimer’s Disease (AD)

PRX012, a potential best-in-class treatment for AD, is an investigational monoclonal antibody targeting a key epitope at the N-terminus of amyloid beta (Aβ) with high binding potency supporting subcutaneous administration

Received U.S. Food and Drug Administration (FDA) clearance of the Investigational New Drug (IND) application
Received Fast Track designation for PRX012 from FDA for the treatment of AD
Initiated Phase 1 single ascending dose (SAD) study, a randomized, double-blind, placebo-controlled study to evaluate safety, tolerability, immunogenicity, and pharmacokinetics in healthy volunteers and patients with Alzheimer’s disease
Phase 1 multiple ascending dose (MAD) study initiation expected by year-end 2022
Topline Phase 1 data expected in 2023
PRX005, a potential best-in-class treatment for AD, is an investigational antibody that specifically targets a key epitope within the microtubule binding region (MTBR) of tau, a protein implicated in diseases including AD, frontotemporal dementia (FTD), progressive supranuclear palsy (PSP), chronic traumatic encephalopathy (CTE), and other tauopathies. PRX005 is part of the global neuroscience research and development collaboration with Bristol Myers Squibb

Topline Phase 1 data expected in 2022
Dual Aβ /tau vaccine, a potential first-in-class treatment and prevention therapy for AD, is a dual-target vaccine targeting key epitopes within the Aβ and tau proteins to promote amyloid clearance and blockade of pathogenic tau

Oral presentation on preclinical data at the International Conference on Alzheimer’s and Parkinson’s Diseases (AD/PD 2022) in March demonstrating that Prothena’s dual Aβ/tau vaccine generated anti-Aβ and anti-tau antibodies to enable phagocytosis of Aβ and to neutralize tau
IND filing expected in 2023
Parkinson’s Disease (PD)

Prasinezumab, a potential first-in-class treatment for PD, is a humanized monoclonal antibody designed to target key epitopes within the C-terminus of alpha-synuclein and is the focus of the worldwide collaboration with Roche

Oral presentation by partner Roche at AD/PD 2022 on the Phase 2 PASADENA study of prasinezumab, further supports a potential effect on delaying motor progression in patients
Phase 2b PADOVA study results expected in 2024
Rare Peripheral Amyloid Diseases Portfolio

AL Amyloidosis

Birtamimab, a potential best-in-class amyloid depleter treatment for AL amyloidosis, is an investigational humanized monoclonal antibody designed to directly neutralize soluble toxic aggregates and promote clearance of amyloid that causes organ dysfunction and failure

Confirmatory Phase 3 AFFIRM-AL study results expected in 2024
ATTR Amyloidosis

PRX004, a potential first-in-class treatment for ATTR amyloidosis, is a humanized monoclonal antibody designed to deplete the pathogenic, non-native forms of the TTR protein, that is being developed by Novo Nordisk for the treatment of ATTR cardiomyopathy

Novo Nordisk expects to initiate a Phase 2 study of PRX004 for the treatment of ATTR cardiomyopathy in 2Q 2022
Upcoming Investor Conferences

Members of the senior management team will present and participate in investor meetings at the following upcoming investor conferences:

BofA Securities 2022 Healthcare Conference, May 10, 2022, at 9:20 AM PT/12:20 PM ET
H.C. Wainwright Global Investment Conference, May 24, 2022, on demand presentations available starting at 7:00 AM ET
First Quarter 2022 Financial Results

For the first quarter of 2022, Prothena reported a net loss of $36.3 million, as compared to a net loss of $36.7 million for the first quarter of 2021. Net loss per share for the first quarter of 2022 was $0.78, as compared to net loss per share of $0.91 for the first quarter of 2021.

Prothena reported total revenue of $1.2 million for the first quarter of 2022, primarily from collaboration revenue from Bristol Myers Squibb. As compared to total revenue of $0.2 million for the first quarter of 2021, from collaboration and license revenue from Roche.

Research and development (R&D) expenses totaled $27.3 million for the first quarter of 2022, as compared to $21.1 million for the first quarter of 2021. The increase in R&D expense for the first quarter of 2022 compared to the same period in the prior year was primarily due to higher manufacturing costs, primarily related to the birtamimab program, higher personnel related expenses, higher clinical trial expenses primarily related to the PRX012, birtamimab and PRX005 programs, and higher other R&D expense, offset in part by lower collaboration expenses related to the prasinezumab program with Roche as a result of the cost share opt-out exercised in May 2021. R&D expenses included non-cash share-based compensation expense of $3.3 million for the first quarter of 2022, as compared to $2.0 million for the first quarter of 2021.

General and administrative (G&A) expenses totaled $11.8 million for the first quarter of 2022, as compared to $11.1 million for the first quarter of 2021. The increase in G&A expenses for the first quarter of 2022 compared to the same period in the prior year was primarily related to higher personnel expense and higher consulting expenses, offset in part by lower legal expense and lower expense for our director and officer insurance premium. G&A expenses included non-cash share-based compensation expense of $4.3 million for the first quarter of 2022, as compared to $4.2 million for the first quarter of 2021.
Total non-cash share-based compensation expense was $7.7 million for the first quarter of 2022, as compared to $6.2 million for the first quarter of 2021.

As of March 31, 2022, Prothena had $544.3 million in cash, cash equivalents and restricted cash, and no debt.

As of April 28, 2022, Prothena had approximately 46.8 million ordinary shares outstanding.

2022 Financial Guidance

The Company continues to expect the full year 2022 net cash used in operating and investing activities to be $120 to $132 million, which includes an expected $40 million clinical milestone payment from Novo Nordisk and expects to end the year with approximately $454 million in cash, cash equivalents and restricted cash (midpoint). The estimated full year 2022 net cash used in operating and investing activities is primarily driven by an estimated net loss of $154 to $170 million, which includes an estimated $32 million of non-cash share-based compensation expense. (Press release, Prothena, MAY 5, 2022, View Source [SID1234613796])

On May 5, 2022 Codiak BioSciences, Inc. (NASDAQ: CDAK), a clinical-stage biopharmaceutical company focused on pioneering the development of exosome-based therapeutics as a new class of medicines, reported first quarter 2022 financial results and operational progress (Press release, Codiak Biosciences, MAY 5, 2022, View Source [SID1234613842]).

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"We are making exciting progress with our clinical and preclinical programs, which continue to generate further confirmatory evidence that our engEx Platform can harness exosomes for potent and selective delivery of therapeutics, not only in immuno-oncology, but in vaccines and gene therapy as well," said Douglas E. Williams, Ph.D., President and Chief Executive Officer of Codiak. "We remain on track to deliver on several key milestones by the end of this quarter, including results from all five dose cohorts in our exoSTING trial, initial CTCL patient data from the exoIL-12 program, and commencement of dosing in the Phase 1 study of our third candidate to enter the clinic, exoASO-STAT6."

First Quarter 2022 and Recent Highlights

Completed enrollment and dose escalation in cohorts 4 and 5 in the Phase 1/2 clinical trial of exoSTING (CDK-002) for the treatment of advanced/metastatic, recurrent and injectable solid tumors; patient follow-up continues in all dose cohorts, as well as enrollment of enrichment cohorts
Advanced cutaneous T cell lymphoma (CTCL) portion of Phase 1 trial of exoIL-12 (CDK-003); implemented plans for protocol amendment to include a broader range of CTCL patients, and developed plans to enroll patients with additional cutaneous malignancies responsive to rIL-12
Activated sites for Phase 1 trial of exoASO-STAT6 (CDK-004) for the intravenous treatment of hepatocellular carcinoma in preparation for patient dosing
Presented new preclinical data from the exoVACC pan-beta coronavirus vaccine program, as part of Codiak’s collaboration with the Ragon Institute, at the World Vaccine Congress 2022
Presented preclinical data for exoASO-C/EBPb, a proprietary engineered exosome loaded with antisense oligonucleotides targeting C/EBPβ, at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting
Published a manuscript describing the full exoASO-STAT6 preclinical program in the American Association for the Advancement of Science’s journal, Science Advances
Named industry veteran oncology drug developer David Mauro, M.D., Ph.D. as Chief Medical Officer
Anticipated Milestones and Events

First patients dosed in exoASO-STAT6 Phase 1 clinical trial in hepatocellular carcinomas anticipated during 1H 2022
Safety, PK, PD, objective response rate (ORR), and efficacy data in injected and non-injected tumors from dose escalation cohorts 1-5 in the Phase 1/2 trial of exoSTING and recommended Phase 2 dose expected in late 1H 2022
Initial safety, PK/PD and efficacy data from at least the first cohort of CTCL patients in the Phase 1 clinical trial of exoIL-12 anticipated in late 1H 2022
Presentation of new data from engEx-AAV discovery program describing the generation of potent and high-yield exosome-associated AAV constructs as a strategy for improving gene therapy delivery at the American Society of Gene and Cell Therapy Annual Meeting to be held May 16-19, 2022
Dr. Williams added, "As we have noted in prior quarters, enrollment in the exoIL-12 study at trial sites in the UK has been challenging, and we have worked to pursue options for expediting enrollment. We’re looking forward to the positive impact of protocol enhancements for this trial to include a broader CTCL population (stage IIIa) and the potential to enroll patients with cutaneous malignancies responsive to rIL-12 in past studies – including Kaposi’s sarcoma, Merkel cell carcinoma, and Squamous cell carcinoma – each orphan cutaneous diseases treated by the same physicians, where local treatment is common."

First Quarter 2022 Financial Results

Total revenues for the quarter ended March 31, 2022, were $12.7 million, compared to $13.2 million for the same period in 2021. These results reflect deferred revenue recognized under the Company’s collaboration with Jazz Pharmaceuticals.

Net loss for the quarter ended March 31, 2022, was $8.0 million, compared to a net loss of $10.3 million for the same period in 2021. The decrease in net loss for the quarter was driven primarily by a reduction in research and development expenses, some of which were in connection with the Company’s agreement with Lonza.

Research and development expenses were $14.2 million for the quarter ended March 31, 2022, compared to $16.6 million for the same period in 2021. The decrease in research and development expenses was driven primarily by decreases in lab expenses and personnel-related costs in connection with our agreement with Lonza.

General and administrative expenses were $6.7 million for the quarter ended March 31, 2022, compared to $6.6 million for the same period in 2021. The increase was driven primarily by an increase in personnel expenses.

As of March 31, 2022, Codiak had cash, cash equivalents, and marketable securities of approximately $56.5 million.

On May 4, 2022 Charles River Laboratories International, Inc. (NYSE: CRL) reported its results for the first quarter of 2022 (Press release, Charles River Laboratories, MAY 4, 2022, View Source [SID1234613478]). For the quarter, revenue was $913.9 million, an increase of 10.8% from $824.6 million in the first quarter of 2021.

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Acquisitions contributed 4.7% to consolidated first-quarter revenue growth. The divestiture of the Research Models and Services operations in Japan (RMS Japan) in October 2021 reduced reported revenue growth by 1.6%. The impact of foreign currency translation reduced reported revenue growth by 1.7%. Excluding the effect of these items, organic revenue growth of 9.4% was driven by contributions from all three business segments.

On a GAAP basis, first-quarter net income attributable to common shareholders was $93.0 million, an increase of 51.2% from net income of $61.5 million for the same period in 2021. First-quarter diluted earnings per share on a GAAP basis were $1.81, an increase of 50.8% from $1.20 for the first quarter of 2021. The increases in the GAAP net income and earnings per share were driven primarily by higher revenue and operating income, as well as lower costs associated with the Company’s debt refinancing activities in the first quarter of 2021.

On a non-GAAP basis, net income from continuing operations was $141.1 million for the first quarter of 2022, an increase of 9.3% from $129.2 million for the same period in 2021. First‑quarter diluted earnings per share on a non-GAAP basis were $2.75, an increase of 8.7% from $2.53 per share for the first quarter of 2021. The non-GAAP net income and earnings per share increases were driven primarily by higher revenue and operating margin improvement, partially offset by a higher tax rate and increased interest expense.

James C. Foster, Chairman, President and Chief Executive Officer, said, "We are pleased with our solid, first-quarter financial results that were in line with our expectations, and believe we are continuing to distinguish ourselves from the competition in the current business environment. We continue to benefit from strong, sustained business trends, including record booking activity and robust backlog growth in the Discovery and Safety Assessment segment, that is affording us exceptional visibility into future demand as studies are booked well into 2023. We believe these trends, coupled with the continued strength of biopharmaceutical client spending, support our expectation that the revenue growth rate will accelerate from the first-quarter level, positioning us to achieve our financial guidance for the year."

First-Quarter Segment Results

Research Models and Services (RMS)

Revenue for the RMS segment was $176.5 million in the first quarter of 2022, essentially unchanged from $176.9 million in the first quarter of 2021. Reported revenue growth was reduced by 7.7% due to the divestiture of RMS Japan, and by 1.2% due to the impact of foreign currency translation. Organic revenue growth of 8.7% was driven by broad-based growth for research models, particularly in North America, and research model services, particularly in the Insourcing Solutions (IS) business.

In the first quarter of 2022, the RMS segment’s GAAP operating margin increased to 27.1% from 25.4% in the first quarter of 2021. On a non-GAAP basis, the operating margin increased to 29.9% from 28.7% in the first quarter of 2021. The GAAP and non-GAAP operating margin increases were driven primarily by operating leverage from higher sales of research models.

Discovery and Safety Assessment (DSA)

Revenue for the DSA segment was $544.3 million in the first quarter of 2022, an increase of 8.6% from $501.2 million in the first quarter of 2021. The impact of foreign currency translation reduced revenue by 1.6%, while acquisitions contributed 0.7% to DSA revenue growth. Organic revenue growth of 9.5% was primarily driven by the Safety Assessment business.

In the first quarter of 2022, the DSA segment’s GAAP operating margin increased to 19.3% from 18.1% in the first quarter of 2021. The GAAP operating margin increase was driven by lower acquisition-related adjustments associated with contingent consideration. On a non-GAAP basis, the operating margin decreased to 22.9% from 23.8% in the first quarter of 2021, primarily reflecting higher staffing costs.

Manufacturing Solutions (Manufacturing)

Revenue for the Manufacturing segment was $193.1 million in the first quarter of 2022, an increase of 31.8% from $146.5 million in the first quarter of 2021. The acquisitions of the Cognate BioServices (Cognate) and Vigene Biosciences (Vigene) CDMO businesses contributed 24.4% to Manufacturing revenue growth, while the impact of foreign currency translation reduced revenue by 2.7%. Organic revenue growth of 10.1% was driven by strong demand for Biologics Testing Solutions services, with Microbial Solutions revenue also increasing.

In the first quarter of 2022, the Manufacturing segment’s GAAP operating margin decreased to 24.0% from 33.8% in the first quarter of 2021. On a non-GAAP basis, the operating margin decreased to 33.1% from 35.5% in the first quarter of 2021. The GAAP and non-GAAP operating margin decreases were driven primarily by the additions of Cognate and Vigene. Higher amortization and other integration costs associated with these acquisitions also contributed to the GAAP operating margin decline.

Updates 2022 Guidance

The Company is updating its 2022 financial guidance, which was previously provided on February 16, 2022. Reported revenue growth guidance is being increased by 50 basis points to 13.5% to 15.5% to reflect the Explora BioLabs acquisition, which was completed on April 5, 2022, partially offset by unfavorable movements in foreign currency translation. Organic revenue growth guidance remains unchanged for 2022.

The Company is maintaining its non-GAAP earnings per share guidance as a result of its first-quarter financial performance that was in line with prior expectations and an outlook of accelerating revenue growth during the remainder of the year. The 2022 non-GAAP earnings per share outlook includes a higher-than-expected tax rate, due principally to a lower excess tax benefit associated with stock-based compensation in the first quarter, as well as increased interest expense due to higher rate assumptions for the year. GAAP earnings per share guidance is being lowered to reflect amortization and other acquisition-related costs associated with Explora BioLabs, as well as the first-quarter loss from venture capital and other strategic investments.

Footnotes to Guidance Table:

(1) The contribution from acquisitions/divestitures (net) reflects only those transactions that have been completed.

(2) Organic revenue growth is defined as reported revenue growth adjusted for acquisitions, divestitures, the 53rd week in 2022, and foreign currency translation.

(3) Acquisition-related amortization includes an estimate of $0.05-$0.15 for the impact of the Explora BioLabs acquisition because the preliminary purchase price allocation has not been completed.

(4) These adjustments are related to the evaluation and integration of acquisitions and divestitures, and primarily include transaction, advisory, and certain third-party integration costs, as well as adjustments related to contingent consideration and certain costs associated with acquisition-related efficiency initiatives.

(5) Venture capital and other strategic investment performance only includes recognized gains or losses. The Company does not forecast the future performance of these investments.

(6) These items primarily relate to charges associated with U.S. and international tax legislation that necessitated changes to the Company’s international financing structure; environmental litigation costs related to the Microbial Solutions business; and severance and other costs related to the Company’s efficiency initiatives.

Webcast

Charles River has scheduled a live webcast on Wednesday, May 4th, at 9:30 a.m. ET to discuss matters relating to this press release. To participate, please go to ir.criver.com and select the webcast link. You can also find the associated slide presentation and reconciliations of GAAP financial measures to non-GAAP financial measures on the website.

Bank of America Healthcare Conference Presentation

Charles River will present at the Bank of America 2022 Healthcare Conference in Las Vegas, Nevada, on Wednesday, May 11th, at 1:20 p.m. PT (4:20pm ET). Management will provide an overview of Charles River’s strategic focus and business developments.

A live webcast of the presentation will be available through a link that will be posted on ir.criver.com. A webcast replay will be accessible through the same website shortly after the presentation and will remain available for approximately two weeks.

Non-GAAP Reconciliations

The Company reports non-GAAP results in this press release, which exclude often-one-time charges and other items that are outside of normal operations. A reconciliation of GAAP to non-GAAP results is provided in the schedules at the end of this press release.

On May 4, 2022 Catalyst Clinical Research, a market-leading provider of clinical research services, reported a strategic acquisition of Aptus Clinical to expand the geographic reach of the two companies, and to enhance patient access to advanced, life-changing therapies (Press release, Catalyst Clinical Research, MAY 4, 2022, View Source [SID1234613510]). Together, the two entities will become one multi-region clinical research organization with an accelerated growth trajectory in both the U.S. and Europe.

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Catalyst’s offerings will now encompass extensive and expanded clinical consulting services, as it inherits Aptus’ strong and established relationship with the Experimental Cancer Medicine Centre (ECMC) network to support trial set-up and clinical design input. Positioned at the forefront of novel cancer treatment trends, Catalyst’s active portfolio serves more than 5,300 cancer patients in need and will grow by nearly 600 patients concurrent to this acquisition.

"We are thrilled to be working with Aptus Clinical to expand our reach in the European market, serving clients around the globe to help develop innovative new therapies, improve patient outcomes and enhance our company’s long-term impact," said Catalyst Clinical Research CEO, Nick Dyer. "Our complementary service offerings and therapeutic area alignment will improve outcomes for all our clients."

"Catalyst continues to prove its capabilities as a leader in oncology clinical development and as a preferred strategic acquirer for growing businesses," said Vern Davenport, Partner at NovaQuest Capital Management and Catalyst Board Chairman. "Aptus provides Catalyst with a highly capable team of experts in Europe to accelerate its global ambitions, of which we are incredibly supportive." Catalyst Clinical Research is a portfolio company of global platform NovaQuest Capital Management, LLC.

Formed in 2014 by three former AstraZeneca clinical development experts, Aptus Clinical has rapidly established itself as a specialist CRO offering flexible clinical research solutions in oncology, cell and gene therapies and rare diseases. Together the companies, operating as Catalyst Oncology, will continue to deliver on a portfolio of more than 100 active oncology studies via a network of 500 keenly involved investigator sites. Additional studies outside the Oncology therapeutic area will be delivered under the Catalyst Flex solution and operating models.

"We are proud to partner with Catalyst to strengthen our shared commitment to delivering cutting edge science to patient populations who are in desperate need of new therapies", said Aptus Clinical CEO, Dr. Steve McConchie. "We firmly believe Aptus Clinical and Catalyst are better together and look forward to combining our decades of experience in developing and delivering high quality clinical trials to support our combined organisation to become a significant global provider of innovative clinical research solutions."

Combined headcount for the unified company will now exceed 800 staff members. Catalyst will also work to leverage Aptus’ strategic site relationships integrating them into its own site network spanning North America and Europe. The clinical research organization joined forces with Triangle Biostatistics in 2019, and then with Ce3 in 2020. Although this is Catalyst’s third M&A transaction, it is its first international union that will accelerate and expand the companies’ geographic reach greatly.

On May 4, 2022 DiaMedica Therapeutics Inc. (Nasdaq: DMAC), a clinical-stage biopharmaceutical company focused on developing novel treatments for neurological disorders and kidney diseases, reported financial results for the quarter ended March 31, 2022 (Press release, DiaMedica, MAY 4, 2022, View Source [SID1234613526]). DiaMedica will host a conference call on Thursday, May 5, 2022, at 8:00AM Eastern Time / 7:00AM Central Time, to discuss its business update and first quarter financial results.

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Clinical Developments

DM199 for the Treatment of Acute Ischemic Stroke

DiaMedica reported that it has increased the number of activated clinical trial sites to 9, more than doubling the number of active sites reported in March 2022 and is currently on track with its site activation goals for its ReMEDy2 trial, which 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). DiaMedica believes that it has experienced slower than expected site activations and enrollment in the ReMEDy2 trial due primarily to staffing shortages and overall resourcing at study sites due to the COVID-19 pandemic and challenges of the study sites managing logistics and compliance for patients discharged from the hospital to an intermediate care facility. The Company is putting resources and processes in place to address both of these issues and expects continued improvement in site activations and patient enrollment over the course of 2022, subject to new pandemic related challenges which may arise for study sites.

DM199 for the Treatment of Chronic Kidney Disease

As previously reported, patient enrollment is completed in DiaMedica’s Phase 2 REDUX trial, which is a multi-center, open-label, investigation to assess the safety and efficacy of multiple doses of DM199, administered over 90 days, in participants with chronic kidney disease (CKD) (Stage 2 or 3).

In total, 79 patients were enrolled and initiated treatment, including 21 African American patients in Cohort 1, 25 patients with IgAN in Cohort 2 and 33 patients with Type 2 diabetes in Cohort 3. The last patient visit was completed in March 2022 and DiaMedica is working to complete the study close-out and the final data analysis while evaluating next steps for the CKD program.

Balance Sheet and Cash Flow

DiaMedica reported total cash and investments of $41.0 million, consisting of cash and cash equivalents of $3.0 million and marketable securities of $38.0 million, current liabilities of $1.4 million and working capital of $40.7 million as of March 31, 2022, compared to total cash and investments of $45.1 million, $1.5 million in current liabilities and $43.9 million in working capital as of December 31, 2021. The decreases in cash and investments and in working capital were due primarily to cash used to fund operating activities during the quarter ended March 31, 2022.

Net cash used in operating activities for the three months ended March 31, 2022, was $3.9 million compared to $4.3 million for the three months ended March 31, 2021. This decrease relates primarily to reduced effects of changes in operating assets and liabilities on the net cash used in operating activities in the current year period.

Financial Results

Research and development (R&D) expenses were $2.0 million for the three months ended March 31, 2022, compared with $2.4 million for the three months ended March 31, 2021, a decrease of $0.4 million. This decrease was driven mainly by a reduction in costs related to the REDUX CKD trial and a lower level of DM199 manufacturing process development work in the current year quarter as compared to the prior year quarter. These decreases were partially offset by increased costs incurred in the ReMEDy2 AIS trial and higher personnel costs related to the expansion of the clinical team in the current year period.

General and administrative (G&A) expenses were $1.6 million for the three months ended March 31, 2022, up from $1.2 million for the three months ended March 31, 2021. This $0.4 million increase resulted from a combination of increased professional services costs, directors’ and officers’ liability insurance and personnel costs incurred in support of expanding the operations and clinical programs.

Conference Call and Webcast Information

DiaMedica Management will host a conference call and webcast to discuss its business update and first quarter 2022 financial results on Thursday, May 5, 2022, at 8:00 AM Eastern Time / 7:00 AM Central Time:

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 play back on DiaMedica’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 May 12, 2022, by dialing (800) 770-2030 (US Toll Free) and entering the replay passcode: 4814247.

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 AIS patients. The trial is intended to enroll approximately 350 patients at 75 sites in the United States. Patients enrolled in the trial will be treated for three weeks with either DM199 or placebo beginning within 24 hours of the onset of AIS symptoms, with the final follow-up at 90 days. The trial excludes patients treated with tissue plasminogen activator (tPA) and/or mechanical thrombectomy. The study population is representative of the approximately 80% of AIS patients who do not have treatment options today, primarily due to the limitations on treatment with tPA or mechanical thrombectomy. DiaMedica believes that the proposed trial has the potential to serve as a pivotal registration study of DM199 in this patient population.

The ReMEDy2 trial has two separate, independent, primary endpoints based upon both the results observed in the first ReMEDy1 phase 2 trial and published results from the urine-derived form of KLK1 used to successfully treat AIS in China. ReMEDy2 is powered for success with either endpoint: 1) physical recovery from stroke as measured by the well-established modified Rankin Scale (mRS) at day 90, and 2) the rate of ischemic stroke recurrence through day 90. Recurrent strokes represent 25% of all ischemic strokes, often occurring in the first few weeks after an initial stroke and are typically more disabling, costly, and fatal than initial strokes.

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 a recombinant form of the KLK1 protein. The KLK1 protein, produced from porcine pancreas and human urine, has been used to treat patients in Japan, China and South Korea for decades. DM199 is currently being studied in patients with acute ischemic stroke and patients with chronic kidney disease. In September 2021, the U.S. Food and Drug Administration granted Fast Track Designation to DM199 for the treatment of acute ischemic stroke.