On May 15, 2023 DiaMedica Therapeutics Inc. (Nasdaq: DMAC), a clinical-stage biopharmaceutical company focused on developing novel treatments for neurological disorders and kidney diseases, reported a business update and financial results for the quarter ended March 31, 2023 (Press release, DiaMedica, MAY 15, 2023, View Source [SID1234631714]). Management will host a conference call Tuesday, May 16, 2023, at 7:00AM Central Daylight Time/8:00AM Eastern Daylight Time to discuss its business update and first quarter 2023 financial results.

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Clinical Developments

ReMEDy2 Phase 2/3 Trial for Acute Ischemic Stroke – Clinical Hold Update

DiaMedica plans to file complete response requesting hold lift this week

DiaMedica plans to file a clinical hold response with the U.S. Food and Drug Administration (FDA) by the end of the week. This request for lifting the clinical hold will include the submission of requested additional supporting data to address prior issues that led to the clinical hold in July 2022. DiaMedica has completed supplemental in-use studies as requested by the FDA. These studies, performed at an independent laboratory, were conducted in two parts. Part 1 simulated actual use of DM199 administration in a hospital setting and Part 2 evaluated worst-case scenarios such as varying storage durations, temperature(s) and light exposure to DM199. DiaMedica believes data from Part 1 confirmed its conclusions from prior testing that the intravenous (IV) dose administered in the ReMEDy2 study was higher than planned due to the change in IV bag materials and was the cause of the hypotension. Accordingly, a dose revision in ReMEDy2 from 1.0 µg/kg to 0.5 µg/kg should avoid or minimize the risk of clinically significant hypotension while still reaching what we believe will be a therapeutic blood concentration level. Additionally, results from part 2 of the in-use study were substantially consistent with Part 1 indicating that no special handling instructions should be required. These results are also similar to the Company’s IV bag study completed in the fall of 2022. The Company further notes that there are no proposed changes to the ensuing three weeks of subcutaneous dosing under the study protocol.

As previously announced, the Company provided responses to FDA inquiries on a potential trypsin impurity contributing to hypotension and methods assays to be used to measure results in the in-use study. The FDA responded to the Company indicating that the assays developed for the in-use study appeared appropriate and its assessment of the potential trypsin impurity was also acceptable.

"With the pending submission of our request to lift the clinical hold, we are optimistic that we have fully identified the cause for last year’s unexpected hypotensive events and have provided the FDA with adequate data to support our position and allow the FDA to lift the clinical hold," commented Rick Pauls, DiaMedica’s Chief Executive Officer. "We look forward to receiving the FDA’s response and hope to then be able to resume our work advancing the science of stroke care."

DiaMedica also completed, in healthy volunteers, a Phase 1C open label, single ascending dose (SAD) study of DM199, administered with the polyvinylchloride (PVC) IV bags used in the ReMEDy2 trial. The purpose of the study was to confirm, with human data, that the revised IV dose of DM199, 0.5 µg/kg, was well-tolerated in humans and achieved an appropriate DM199 blood concentration level similar to prior clinical trials and in the desired therapeutic range. The results from this study will be included as additional supporting data in the Company’s clinical hold response package to the FDA.

"Patient safety is paramount for DiaMedica and we’re pleased to go above and beyond to achieve that end," stated Kirsten Gruis, M.D., DiaMedica’s Chief Medical Officer. "Data developed in our Phase 1C study at the 0.5 µg/kg IV dose level has demonstrated similar DM199 exposure with the IV dosing regimen used in our ReMEDy1 AIS trial. These results, in addition to the in-use study, give us further assurance that we have identified the correct DM199 IV dose level and we hope that this will also give confidence to physician investigators once we are able to resume the ReMEDy2 trial."

Balance Sheet and Cash Flow

DiaMedica reported total cash, cash equivalents and investments of $28.7 million, current liabilities of $2.8 million and working capital of $26.9 million as of March 31, 2023, compared to total cash, cash equivalents and investments of $33.5 million, $2.2 million in current liabilities and $31.7 million in working capital as of December 31, 2022. 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, 2023. After the end of the quarter, DiaMedica received $750,000 from a private investment from its newly appointed Chief Business Officer.

Net cash used in operating activities for the three months ended March 31, 2023 was $5.1 million compared to $3.9 million for the three months ended March 31, 2022. The increase in cash usage relates primarily to the increased net loss in the current year period over the prior year period, partially offset by non-cash share-based compensation and the effects of changes in operating assets and liabilities in the current year period.

Financial Results

Research and development (R&D) expenses increased to $3.6 million for the three months ended March 31, 2023, up $1.6 million from $2.0 million for the three months ended March 31, 2022. The increased costs were driven by a number of factors, including primarily increased manufacturing and process development costs, the costs for the in-use study performed to address the clinical hold on the IND for the ReMEDy2 trial, costs incurred for the Phase 1C health volunteer study and increased personnel costs associated with expansion of the clinical team. These increases were partially offset by decreased costs incurred in the Phase 2/3 ReMEDy2 trial due to the clinical hold.

General and administrative (G&A) expenses were $1.9 million for the three months ended March 31, 2023, up from $1.6 million for the three months ended March 31, 2022. The increase was primarily due to recruiting costs incurred in conjunction the expansion of the Company’s team and increased legal fees incurred in connection with the Company’s lawsuit against Pharmaceutical Research Associates Group B.V., which was acquired by and is now a subsidiary of ICON plc.

Conference Call and Webcast Information

DiaMedica Management will host a conference call and webcast to discuss its business update and first quarter 2023 financial results on Tuesday, May 16, 2023, at 8:00 AM Eastern Time / 7:00 AM Central Time:

Date:

Tuesday, May 16, 2023

Time:

7:00 AM CT / 8:00 AM ET

Web access:

View Source

Dial In:

(877) 550-1858

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 play back 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 May 23, 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 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.

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 Japan, China and South Korea for decades. DM199 is currently being studied in patients with acute ischemic stroke (AIS) and patients with chronic kidney disease. In September 2021, the FDA granted Fast Track Designation to DM199 for the treatment of AIS.

On May 15, 2023 Decibel Therapeutics (Nasdaq: DBTX), a clinical-stage biotechnology company dedicated to discovering and developing transformative treatments to restore and improve hearing and balance, reported financial results for the first quarter ended March 31, 2023 and provided a corporate update (Press release, Decibel Therapeutics, MAY 15, 2023, View Source [SID1234631713]).

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"2023 is a very important year for Decibel as we work to advance the CHORD global Phase 1/2 trial for DB-OTO, our gene therapy pipeline and DB-020. The initiation of our first gene therapy clinical study is the first of several important inflection points that we expect to occur in 2023, including dosing the initial patients and early clinical readouts from the CHORD clinical trial. We believe DB-OTO has the potential to be a best-in-class gene therapy for individuals with otoferlin-related hearing loss," said Laurence Reid, Ph.D., Chief Executive Officer of Decibel. "The multiple challenges of severe hearing loss continue to drive our vision. Congenital hearing loss is recognized as a potential neurodevelopmental emergency and with our product candidates we are aiming to provide durable, physiological hearing to address this."

Pipeline Highlights and Upcoming Milestones:

Gene Therapies for Congenital, Monogenic Hearing Loss

Initiated CHORD Phase 1/2 Clinical Trial of DB-OTO; Received European Orphan Drug Designation for DB-OTO:
DB-OTO is an AAV-based, dual-vector, gene therapy product candidate designed to be administered a single time to selectively express functional otoferlin (OTOF) in the inner hair cells of individuals with OTOF deficiency with the goal of enabling the ear to transmit sound to the brain and enable durable, physiological hearing. Decibel is developing DB-OTO in collaboration with Regeneron Pharmaceuticals, and Decibel retains global commercial rights to the product candidate.
In May 2023, Decibel announced approval from the Spanish Agency of Medicines and Medical Devices (AEMPS) and in January 2023, Decibel announced approval from the U.K. Medicines and Healthcare Products Regulatory Agency (MHRA) for its Clinical Trial Applications (CTAs) for its CHORD clinical trial of DB-OTO. The Company has previously announced clearance from the U.S. Food and Drug Administration (FDA) for its Investigational New Drug (IND) application for CHORD. Decibel expects that the first two patients in CHORD in the U.S. will be as young as seven years of age and that participants in the U.K. and Spain will be infants two years of age and younger.
In March 2023, the European Medicines Agency (EMA) Committee on Orphan Medicinal Products (COMP) and European Commission (EC) issued orphan drug designation for DB-OTO. Orphan drug designation is granted by the EC for medicines in development to treat rare conditions affecting no more than five in 10,000 people in the European Union, provided there is no other satisfactory treatment option or the medicine can be of significant benefit to those affected by a specific condition. Medicines that are granted orphan drug designation by the EC qualify for financial and regulatory incentives including protocol assistance, possible exemptions or reductions in certain regulatory fees, and, if approved for marketing, ten years of market exclusivity in the European Union.
Announced Presentations Related to DB-OTO and AAV.103 at the American Society of Gene and Cell Therapy (ASGCT) (Free ASGCT Whitepaper) 26th Annual Meeting; Presented New Non-Clinical Safety Data from DB-OTO at the 46th Annual Association for Research in Otolaryngology (ARO) MidWinter Meeting:
In May 2023, Decibel announced it will deliver podium presentations related to DB-OTO and AAV.103 at ASGCT (Free ASGCT Whitepaper). Decibel will also present posters related to its preclinical pipeline and its platform.
In February 2023, Decibel presented new non-clinical data supporting the clinical development of DB-OTO. In Good Laboratory Practices studies, Decibel did not observe any adverse DB-OTO-related findings in otic or non-otic tissues across any evaluation of OTOF-deficient mice or non-human primates.
Selected a Product Candidate for AAV.103 GJB2-Related Hearing Loss Program and Initiated Manufacturing Activities to Support IND-Enabling Studies: In February 2023, Decibel presented preclinical data at ARO on its AAV.103 gene therapy product candidate designed to restore hearing in individuals with mutations in the gap junction beta-2 (GJB2) gene, the leading cause of autosomal recessive, non-syndromic, congenital hearing loss worldwide. Results demonstrated that selective expression of GJB2 in non-sensory cells that normally express GJB2 resulted in robust and durable hearing restoration in a mouse model of GJB2 deficiency. Decibel is developing the AAV.103 program in collaboration with Regeneron Pharmaceuticals and has achieved a pre-IND milestone in April 2023 related to initiation of manufacturing under the collaboration agreement. Decibel retains global commercial rights to the product candidate.
Otoprotection Therapeutic

DB-020 Phase 1b Clinical Trial Data to Be Presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2023 Annual Meeting: Decibel will present data from the Phase 1b clinical trial of DB-020, its product candidate for prevention of cisplatin-induced hearing loss in patients receiving cisplatin chemotherapy. In the interim results from the trial, DB-020 demonstrated reduced ototoxicity, a favorable safety and tolerability profile and no observed effect on systemic cisplatin pharmacokinetics (PK) in such patients. The Company is seeking advice from regulatory agencies concerning the future development of DB-020.
Corporate Update:

Board of Directors Update: In March 2023, Decibel announced the appointment of Matthew Kapusta, MBA, to its Board of Directors. Mr. Kapusta serves as the CEO of uniQure, a gene therapy company.
First Quarter 2023 Financial Results:

Cash Position: As of March 31, 2023, cash, cash equivalents and available-for-sale securities were $87.9 million, compared to $104.6 million as of December 31, 2022.
Research and Development Expenses: Research and development expenses were $7.9 million for the first quarter of 2023, compared to $7.5 million for the same period in 2022. The increase in research and development expenses for the first quarter of 2023 was primarily due to costs to prepare for the Company’s Phase 1/2 clinical trial of DB-OTO, higher research costs related to its other preclinical gene therapy programs and higher personnel-related costs due to increased headcount and wages.
General and Administrative Expenses: General and administrative expenses were $6.2 million for the first quarter of 2023, compared to $6.6 million for the same period in 2022. The decrease in general and administrative expenses for the first quarter of 2023 was primarily due to lower professional fees including external consulting, advisory, legal and audit services.
Financial Guidance:

Based on its current operating and development plans, Decibel believes that its existing cash, cash equivalents and available-for-sale securities will fund its planned operating expenses into the first half of 2024.

On May 15, 2023 CymaBay Therapeutics, Inc. (NASDAQ: CBAY), a biopharmaceutical company focused on developing innovative therapies for liver and other chronic diseases, reported corporate updates and financial results for the first quarter ended March 31, 2023 (Press release, CymaBay Therapeutics, MAY 15, 2023, View Source [SID1234631712]).

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Sujal Shah, President and CEO of CymaBay, stated, "In a year with RESPONSE pivotal phase 3 data fast approaching, we have already achieved a number of key goals thus far in 2023. In January, we licensed rights to Kaken Pharmaceutical Company to develop and commercialize seladelpar for patients with PBC in Japan and strengthened our balance sheet with a successful financing. In April, we announced that the ENHANCE phase 3 trial results were published in Hepatology, a preeminent medical journal in the field of liver disease. Last week, we announced the appointment of Harish Shantharam as Chief Financial Officer. These accomplishments set up the remainder of 2023 as we look to share data from RESPONSE, manufacture commercial supplies of seladelpar, prepare regulatory filings and advance our pre-commercial planning. We look forward to sharing updates across all of these activities through the remainder of the year."

Corporate Updates:

Appointed Harish Shantharam to the role of Chief Financial Officer in May 2023. Harish brings nearly 20 years of experience leading financial functions in biotech with a strong emphasis on setting strategy and building financial planning and accounting operations to prepare companies for commercial drug launch.
ENHANCE manuscript titled "Seladelpar efficacy and safety at 3 months in patients with primary biliary cholangitis: ENHANCE, a phase 3, randomized, placebo-controlled study" published in April 2023 in Hepatology, a preeminent journal in the field of liver disease.
Entered into a collaboration and license agreement with Kaken Pharmaceutical Co., Ltd. in January 2023 for the development and commercialization in Japan of CymaBay’s investigational drug seladelpar for the treatment of PBC.
Financial Updates:

Completed a public equity offering in January 2023, in which we sold 11,821,428 shares of common stock at $7.00 per share and pre-funded warrants to purchase 2,142,857 shares of common stock at $6.9999 per share. Net proceeds of the offering were $92.4 million after deducting underwriting commissions and other offering expenses.

Held $236.4 million in cash, cash equivalents and investments as of March 31, 2023. We believe that cash and investments on hand are sufficient to fund CymaBay’s operating plan through the third quarter of 2024.
First Quarter Ended March 31, 2023 Financial Results

Research and development expenses for the three months ended March 31, 2023, and 2022 were $18.6 million and $18.4 million, respectively. Research and development expenses for the three months ended March 31, 2023 had a moderate increase compared to the corresponding period in 2022 primarily due to lower project costs spending on completion of enrollment of our RESPONSE trial and in drug manufacturing and development for PBC offset by higher employee compensation as we continued to hire additional personnel to support our clinical studies.

General and administrative expenses for the three months ended March 31, 2023 and 2022 were $8.3 million and $6.1 million, respectively. General and administrative expenses for the three months ended March 31, 2023 were higher than the corresponding period in 2022 as we continued to add administrative personnel and expand our infrastructure to support our corporate growth.

Net loss for the three months ended March 31, 2023 and 2022 was $28.8 million and $27.8 million, or ($0.29) and ($0.32) per share, respectively. Net loss for the three months ended March 31, 2023 was higher than the corresponding period in 2022 due primarily to an increase in general and administrative expenses, partially offset by higher interest income earned on our investments. Overall, we expect operating expenses to increase in the future as we continue to execute our development and pre-commercialization plans for seladelpar in PBC.

On May 15, 2023 CorMedix Inc. (Nasdaq: CRMD), a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of life-threatening diseases and conditions, reported financial results for the first quarter ended March 31, 2023 and provided an update on recent business developments (Press release, CorMedix, MAY 15, 2023, View Source [SID1234631711]).

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Recent Corporate Highlights:

● As previously guided, CorMedix is resubmitting its DefenCath New Drug Application, or NDA, to the U.S. Food and Drug Administration ("FDA"). The Company anticipates that the NDA will be classified as a Type 2 resubmission with a 6-month review cycle with a target action date in November.

● The Company also recently announced that the US Patent & Trademark office has issued a notice of allowance of patent claims directed to the composition of a catheter lock solution for preventing infection and reduced blood flow in central venous catheters. This newly allowed U.S. Patent Application reflects the unique and proprietary nature of DefenCath, and will extend our current intellectual property protection to an anticipated expiration date in 2042.

● CorMedix recently announced that following our submission of a duplicate New Technology Add-On Payment, or NTAP, application to the Centers for Medicare & Medicaid Services, CMS has issued the Inpatient Prospective Payment System 2024 proposed rule that includes an NTAP of up to $17,111 per hospital stay for DefenCath. This NTAP is conditioned upon the DefenCath NDA obtaining final FDA approval prior to July 1, 2024.

● Cash and short-term investments, excluding restricted cash, at March 31, 2023 amounted to $55.6 million.

Joe Todisco, CorMedix CEO, commented, "we are excited to announce today that our DefenCath NDA is ready to be resubmitted to FDA. The resubmission reflects the hard work of the CorMedix regulatory and technical teams and our strategic partners, and we will now increase our focus on preparations for a potential commercial launch in early 2024. We look forward to providing additional updates as we progress toward potential approval in 2023 and aim to deliver on our commitment to reducing the risk of infections in patients receiving hemodialysis via central venous catheters."

First Quarter 2023 Financial Highlights

For the first quarter of 2023, CorMedix recorded a net loss of $10.6 million, or $0.24 per share, compared with a net loss of $7.0 million, or $0.18 per share, in the first quarter of 2022, an increase of $3.5 million, driven primarily by an increase in operating expenses.

Operating expenses in the first quarter 2023 were $11.0 million, compared with $7.0 million in the first quarter of 2022, an increase of approximately 57%. The increase was driven by higher SG&A expenses which increased approximately 60% to $7.6 million, primarily driven by costs related to market research studies and pre-launch activities in preparation for the potential approval of DefenCath, and an increase in personnel expenses and non-cash charges for stock-based compensation. R&D expenses also increased by 49% to $3.4 million, primarily due to net increases in personnel expenses and non-cash charges for stock-based compensation. Additionally, there were also increases in medical affairs activities in preparation for the potential marketing approval of DefenCath and costs related to the manufacturing of DefenCath prior to its potential marketing approval.

The Company reported cash and short-term investments of $55.6 million at March 31, 2023, excluding restricted cash. The Company believes that it has sufficient resources to fund operations at least through the first half of 2024.

On May 15, 2023 Compugen Ltd. (Nasdaq: CGEN) (TASE: CGEN) a clinical-stage cancer immunotherapy company and a pioneer in computational target discovery, reported financial results for the first quarter ended March 31, 2023 and provided a corporate update on key events since the start of 2023 (Press release, Compugen, MAY 15, 2023, View Source [SID1234631710]).

"I am excited that we are leading the way with a unique triple combination immuno-oncology approach with potential to be the next generation of immunotherapies in a very large market with high unmet need", said Anat Cohen-Dayag, Ph.D., President, and Chief Executive Officer of Compugen. "We have already shown preliminary clinical benefit in two tumor types, typically not responding to immunotherapy, microsatellite stable colorectal cancer and platinum resistant ovarian cancer. To confirm this signal, we have initiated two proof-of-concept studies evaluating the triple blockade of PVRIG, TIGIT and PD-1 with COM701, COM902 and pembrolizumab in these indications and are on track to report initial findings by the end of the year. We believe this strategy provides the fastest route in building a path to registration and de-risk our lead assets, COM701 and COM902."

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Dr. Cohen-Dayag continued, "We continue to feed our own pipeline by leveraging our pioneering computational discovery platform. We presented new data on our lead pre-clinical asset, COM503, in an oral presentation at the recent CIMT (Free CIMT Whitepaper) annual meeting. COM503 is a differentiated, novel anti-IL-18BP antibody based approach to harness cytokine biology for anti-cancer therapeutics. By freeing the body’s own interleukin-18 to stimulate the immune system to fight cancer at the tumor site, COM503 has the potential advantage of avoiding the typical systemic toxicity associated with cytokine therapeutics".

Dr. Cohen-Dayag concluded, "We are driven by our strong belief in the potential of our differentiated assets, internal and partnered, and the opportunity to transform the lives of patients with cancer. Our $74.3 million cash balance as of March 31, 2023 re-affirms our financial discipline, with bold execution on our DNAM-1 axis hypothesis and our newly disclosed lead pre-clinical asset advancing towards IND submission next year. We have cash runway at least through the end of 2024, to support operations, reach milestones and de-risk our lead clinical assets, COM701 and COM902."

Financial Results
As of March 31, 2023, cash, cash equivalents, short-term bank deposits and restricted cash totalled approximately $74.3 million, compared with approximately $83.7 million as of December 31, 2022. The Company expects its existing cash and cash related balances to be sufficient to fund its operations at least through the end of 2024, based on its current plans.

Compugen does not have any debt.

R&D expenses for the first quarter of 2023, were approximately $7.4 million compared with approximately $7.2 million for the comparable period in 2022.

General and administrative expenses for the first quarter of 2023, were approximately $2.6 million, compared with approximately $2.6 million for the comparable period in 2022.

Net loss for the first quarter of 2023, was approximately $9.3 million, or $0.11 per basic and diluted share, compared with a net loss of approximately $9.7 million, or $0.11 per basic and diluted share, in the first quarter of 2022.

Full financial tables are included below.

Conference Call and Webcast Information
The Company will hold a conference call today, May 15, 2023, at 8:30 AM ET to review its first quarter 2023 results. To access the live conference call by telephone, please dial 1-866-744-5399 from the U.S., or +972-3-918-0644 internationally. The call will be available via live webcast through Compugen’s website, located at the following link. Following the live webcast, a replay will be available on the Company’s website.