On November 13, 2019 DiaMedica Therapeutics Inc. (Nasdaq: DMAC), a clinical-stage biopharmaceutical company focused on developing novel treatments for kidney diseases and neurological disorders, reported its financial results for the three and nine months ended September 30, 2019 (Press release, DiaMedica, NOV 13, 2019, View Source [SID1234551144]).

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Clinical Developments

DM199 for the Treatment of Chronic Kidney Disease

Phase Ib Clinical Study in Patients with CKD Completed

DiaMedica has completed its Phase Ib clinical trial of DM199, a recombinant form of the endogenous human tissue kallikrein protein (KLK1), in patients with moderate or severe Chronic Kidney Disease (CKD) caused by Type I or Type II diabetes mellitus. The study was performed to assess the pharmacokinetics (PK) of three dose levels of DM199 (3, 5 and 8 µg/kg), administered in a single subcutaneous dose, as well as the evaluation of safety, tolerability and secondary pharmacodynamic (PD) endpoints.

The Company previously announced positive interim results. PK profiles, at the 3µg/kg dose level, were similar between moderate and severe CKD patients, and consistent with healthy subjects (normal kidney function) tested previously. Therefore, the Company does not believe dosing adjustment is warranted, based on the presence or severity of CKD and a full renal study will likely not be required. Final study results indicated that DM199 was observed to be well tolerated with no dose-limiting tolerability. There were no deaths, no discontinuations due to a treatment-related adverse event (AE), and no treatment-related significant adverse events (SAEs). AEs were minor and consistent with standard treatment(s) in the CKD patient population.

Favorable overall PD results were also observed including short-term improvements in Nitric Oxide (NO), average increase of 35.2%, Prostaglandin E2 (PGE2), average increase of 41.2%, estimated glomerular flow rate (eGFR), average increase of 4.08 mL/min/1732, and the urinary albumin to creatinine ratio (UACR), average decrease of 18.7%. PD results appeared to be drug related in that greatest improvements occurred at approximately 24 hours after DM199 administration and subsequently declined.

DiaMedica intends to release full study results at an upcoming conference, including a breakout analysis of moderate and severe patients and results by dose level.

Phase II Clinical Study in CKD Caused by IgA Nephropathy and African Americans with Hypertension – Screening Commenced

The U.S. Food and Drug Administration (FDA) has accepted the Company’s Phase II clinical trial protocol for the treatment of CKD caused by rare or significant unmet diseases. This study is designed to investigate the safety, efficacy, PK and PD of DM199. Screening of patients has commenced and the enrollment and dosing is expected in the near term.

The Phase II trial named REDUX, latin for restore, is a multi-center, open-label investigation of approximately 60 participants with CKD, who are being enrolled in two cohorts (30 per cohort). The study is being conducted in the United States at up to 10 sites and will be focused on participants with CKD: Cohort I is focused on non-diabetic, hypertensive African Americans with Stage II or III CKD. African Americans are at greater risk for CKD than Caucasians, and those who have the APOL1 gene mutation are at an even higher risk. The study is designed to capture the APOL1 gene mutation as an exploratory biomarker in this cohort; Cohort II is focused on participants with IgA Nephropathy (IgAN). The study will evaluate two dose levels of DM199 within each cohort. Study participants will receive DM199 by subcutaneous injection twice weekly for 95 days. The primary study endpoints include safety, tolerability, blood pressure, proteinuria and kidney function, which will be evaluated by changes from baseline in eGFR and albuminuria, as measured by the UACR.

"We are pleased with the results from our CKD Phase Ib study and our ability to now commence Phase II studies," commented Dr. Harry Alcorn, DiaMedica’s Chief Medical Officer. "We look forward to our Phase II study building on our successful Phase Ib data and we have engaged a number of study sites that have the patient populations and experience in obtaining high quality data to better understand the potential of DM199 in benefitting individuals suffering with CKD, whose current treatment options are very limited."

DM199 for the Treatment of Acute Ischemic Stroke

DM199 Acute Ischemic Stroke Phase II "REMEDY" Trial Update – Enrollment Completed

DiaMedica has recently completed enrollment in the REMEDY trial, the Company’s Phase II study assessing the safety, tolerability and markers of therapeutic efficacy of DM199 in participants suffering from Acute Ischemic Stroke (AIS). Final enrollment was 92 participants. The markers of therapeutic efficacy will include multiple plasma-based biomarkers (e.g. C-reactive protein), the Modified Rankin Scale, National Institutes of Health Stroke Scale and the Barthel Index. These markers are assessed at multiple points throughout the study, including 90 days post-stroke.

Organizational Update

Dr. Sydney A. Gilman has joined DiaMedica as its Vice President of Regulatory Affairs. Dr. Gilman has over 30 years of pharmaceutical industry experience holding senior positions including at Elan Pharmaceuticals and Amylin Pharmaceuticals. Dr. Gilman also spent six years as a CMC reviewer with the FDA’s Center for Drug Evaluation and Research group. In his most recent role as founder and Senior Regulatory Consultant of Trident Rx Consulting, Dr. Gilman has been involved in the development and implementation of strategic plans for drug development and regulatory strategy for new drugs and biologics. In addition he has lead a variety of global regulatory submissions, including INDs, NDAs, BLAs, MAAs, global CTAs, 510Ks, PMAs, orphan and Fast Track submissions, and clinical study reports.

"We continue to make great progress with our clinical programs with the commencement of our Phase II CKD studies and the completion of enrollment in our REMEDY Phase II study, and I wish to thank our clinical team for their skill and dedication," stated Rick Pauls, DiaMedica’s President and CEO. "I would also like to welcome Dr. Gilman, who is a strong addition at this critical time. His proven track record in leading regulatory affairs is instrumental as we transition DM199 into Phase II and Phase III clinical trials and work to improve the lives of CKD and AIS patients."

Financial Results

Research and development (R&D) expenses increased to $1.6 million for the three months ended September 30, 2019, up from $1.2 million for the three months ended September 30, 2018, an increase of $0.4 million. R&D expenses increased to $6.1 million for the nine months ended September 30, 2019, compared to $3.1 million for the nine months ended September 30, 2018, an increase of $3.0 million. The increase for the nine months ended September 30, 2019 was due to costs of approximately $1.4 million incurred for a new production run of the DM199 drug substance, as well as costs incurred in conjunction with the Phase Ib and Phase II clinical studies in CKD patients and related non-clinical testing. Increased personnel and non-cash share-based compensation costs also contributed to the increase. The increase for the three months ended September 30, 2019 was due to costs incurred in conjunction with the Phase Ib and Phase II CKD studies and non-cash share-based compensation costs, partially offset by a decline in costs incurred in conjunction with the REMEDY Phase II stroke study.

General and administrative (G&A) expenses were $1.0 million for the three months ended September 30, 2019, compared to $777,000 for the three months ended September 30, 2018. G&A expenses increased to $2.7 million for the nine months ended September 30, 2019, up from $2.1 million for the nine months ended September 30, 2018. These increases were primarily due to costs associated with our status as a Nasdaq-listed U.S. public reporting company, which commenced in December 2018, including increased professional services, compliance and non-cash share-based compensation costs. Increased personnel costs also contributed to the increase on a year to date basis.

Total other income increased to $225,000 for the three months ended September 30, 2019, up from $157,000 for the prior year period. Total other income decreased to $683,000 for the nine months ended September 30, 2019, compared to $946,000 for the nine months ended September 30, 2018. The year-to-date decrease is primarily related to the initial recognition of R&D incentives from the Australian Government paid for qualifying research work performed by DiaMedica Australia Pty Ltd. during the nine months ended September 30, 2018. The increase in the quarterly comparison relates to increased study costs, compared to the prior year period, driving an increase in the eligible R&D incentive. The year-to-date decrease was partially offset by, and the current quarter increase was augmented by, increased interest income earned on marketable securities during the three and nine months ended September 30, 2019.

Balance Sheet and Cash Flow

The Company had cash and cash equivalents of $4.7 million, marketable securities of $5.0 million, current liabilities of $1.3 million and working capital of $9.6 million as of September 30, 2019, compared to $16.8 million in cash and cash equivalents, $1.3 million in current liabilities and $16.7 million in working capital as of December 31, 2018. The decreases in combined cash and cash equivalents and marketable securities and in working capital are due primarily to the Company’s operating loss incurred for the nine months ended September 30, 2019.

Net cash used in operating activities was $7.2 million for the nine months ended September 30, 2019, compared to $3.8 million for the nine months ended September 30, 2018. The net cash used in each of these periods primarily reflects the net loss for these periods, and was partially offset by non-cash charges for stock-based compensation and the net effects of changes in operating assets and liabilities.

Conference Call Information

DiaMedica management will host a conference call to discuss these results on Thursday, November 14, 2019, at 7:00 a.m. Central Time:

Date:

Thursday, November 14, 2019

Time:

7:00 AM CT / 8:00 AM ET

Web access:

View Source

Dial In:

(844) 557-8483 (domestic)

(825) 312-2381 (international)

Conference ID:

4594493

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 our website, under investor events and presentations, following the earnings call and for 12 months thereafter. A telephonic replay of the conference call will be available until November 21, 2019, by dialing (800) 585-8367 (US Toll Free), (416) 621-4642 (International), replay passcode 4594493.

About DM199
DM199 is a recombinant (synthetic) form of the human serine protease, KLK1. The KLK1 protein 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 chronic kidney disease, retinopathy, stroke, 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 Korea for decades. DM199 is currently being studied in patients with chronic kidney disease and patients with acute ischemic stroke.

On November 13, 2019 Navigation Sciences reported that it will provide an update at the annual Medtech Strategist Innovation Summit San Francisco 2019 Conference on its Image Guided, Video Assisted Surgery (iVATS) technology for the minimally invasive identification and removal of early stage lung cancer, the company (Press release, Navigation Sciences, NOV 13, 2019, View Source [SID1234551178]). The conference will take place in Burlingame, California on November 19, 2019.

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"iVATS is a revolutionary approach to minimally invasive soft tissue surgery that combines surgical instruments with augmented reality software to provide real-time, GPS navigation to precisely remove small tumors with optimal margins while preserving lung function," said Alan Lucas, Navigation Sciences’ co-founder and CEO. "We have made significant progress in product development and pre-clinical testing that puts us on a course to begin a clinical trial in mid-2020. We expect the trial to provide the basis for a 510(k) submission to the FDA for marketing clearance."

The emergence of CT chest scanning as an effective tool in high risk populations to detect lung cancer at an early stage and lower cancer deaths is creating new opportunities to improve lung surgery. Removal of small tumors deep inside the lung with appropriate margins remains a significant challenge, as insufficient distance between the tumor and resection margin is associated with recurrence and death. Current surgical approaches either remove excess tissue via lobectomy, which lowers recurrence risk but results in more impaired lung function, or smaller, wedge resections, which reduces lung impairment but may increase recurrence risk.

The Navigation Sciences solution integrates with multi-modal (imaging and surgery) technology and includes an active, GPS enabled marker (fiducial), proprietary, real-time navigation algorithms, and tumor cutting devices that allow for surgical precision specific to the patient’s anatomy. Radiology images are synchronized with real-time information to enable the clinician to perform surgery with precision guidance. The technology’s proof-of-concept was demonstrated in a Phase I-II clinical trial published in the Journal of Surgical Oncology. In the study, involving 25 patients (23 with early stage lung cancer), there were no significant complications, all nodules were fully resected with negative margins, and the technology was shown to integrate with surgical workflow.

There are an estimated 87,000 patients in the U.S. diagnosed each year with early stage lung cancer and that number is expected to grow with growing recognition of CT X-ray screening’s value in early detection and favorable reimbursement coverage. Beyond lung cancer, the technology has significant potential in other soft tissue cancer surgeries including breast cancer, where an estimated 250,000 lumpectomies are performed annually, as well as liver, thyroid and brain tumors.

The iVATS technology was pioneered by Raphael Bueno, MD Chief, Thoracic Surgery, at Brigham and Women’s Hospital and Professor of Surgery at Harvard Medical School, and Jayender Jagadeesan, PhD, research assistant at BWH and Assistant Professor of Radiology at Harvard Medical School. Drs. Bueno and Jagadeesan are co-founders and shareholders of the company.

About MedTech Strategist
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On November 13, 2019 Oncoceutics, Inc. reported that results from the second and third cohort of the Phase II trial for patients with recurrent glioblastoma treated with the company’s lead imipridone, ONC201, were recently published in the journal Neuro-Oncology (Press release, Oncoceutics, NOV 13, 2019, View Source [SID1234558331]). This manuscript represents the third publication among a series of reports demonstrating durable radiographic regressions with ONC201 in patients with H3 K27M-mutant glioma. The study (NCT02525692) also demonstrated that weekly oral administration of ONC201 given as a single agent was well-tolerated, achieved therapeutic intratumoral concentrations, and intratumoral pharmacodynamic activity in adult recurrent glioblastoma patients.

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ONC201 achieved intratumoral concentrations that exceeded preclinical efficacy thresholds and induced intratumoral biomarkers of pharmacodynamic signaling and apoptosis indicating target engagement. The radiographic regression of multi-focal, multi-recurrent disease with ONC201 administration in an adult recurrent H3 K27M-mutant glioblastoma patient remained durable for >1.5 years. No treatment modifications or discontinuations due to toxicity were observed, including those who underwent re-resection.

A previous publication on the first cohort of the study had demonstrated that ONC201 is well-tolerated in adult recurrent glioblastoma patients with every three-week dosing and achieved an objective radiographic response in a patient harboring the H3 K27M mutation that remained durable for >2.5 years. Other publications have reported radiographic regressions and clinical benefit in pediatric and adult H3 K27M-mutant diffuse midline glioma patients including those with diffuse intrinsic pontine glioma (DIPG).

High-grade glioma with the H3 K27M mutation is the lead indication for ONC201 and FDA has awarded Fast-Track designation to ONC201 for the treatment of adults with this disease who have recurred. The publication is supported by Small Business Innovation Research (SBIR) Fast-track and Bridge grants from the National Cancer Institute of the National Institutes of Health, as well as The Musella Foundation.

"These results indicate weekly ONC201 is very well tolerated and biologically active in a molecular subset of glioblastoma patients associated with biomarkers of dopamine receptor dysregulation," said Isabel Arrillaga-Romany, MD, PhD, Director of Neuro-Oncology Clinical Trials at Massachusetts General Hospital and the Principal Investigator and corresponding author of the study. "The durable regression observed in a 74-year old patient with sub-centimeter multi-focal, multi-recurrent H3 K27M-mutant glioma is particularly noteworthy given the development focus of ONC201 in this subset of brain tumors."

"Overall, the safety and efficacy results with ONC201 in recurrent glioblastoma are promising and unlike any other targeted agent we have evaluated thus far," said Patrick Y. Wen, MD, Director of the Center for Neuro-Oncology at Dana-Farber Cancer Institute and senior author and investigator of the study. "ONC201 continues to be promising as a single agent in molecular subsets of high-grade glioma and the intratumoral pharmacodynamic results suggest the activity of ONC201 may extend beyond H3 K27M-mutant gliomas to high-grade glioma subsets that also exhibit dopamine pathway dysregulation."

On November 13, 2019 GlycoMimetics, Inc. (Nasdaq: GLYC) reported that company executives will provide a corporate update at two upcoming investor relations conferences in November (Press release, GlycoMimetics, NOV 13, 2019, View Source [SID1234551129]). Details are as follows :

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STIFEL HEALTHCARE CONFERENCE (NEW YORK)
Date: Tuesday, November 19, 2019
Time: 4:10 p.m. ET
Presenter: GlycoMimetics CFO Brian Hahn

JEFFERIES 2019 LONDON Healthcare Conference
Date: Thursday, November 21, 2019
Time: 7:20 a.m. GMT
Presenter: GlycoMimetics CEO Rachel King

To access the live webcast and subsequent archived recordings for this presentation, please visit the GlycoMimetics website at www.glycomimetics.com.

On November 13, 2019 Y-mAbs Therapeutics, Inc. (the "Company" or "Y-mAbs") (Nasdaq: YMAB) a late-stage clinical biopharmaceutical company focused on the development and commercialization of novel, antibody-based therapeutic products for the treatment of cancer, reported financial results for the third quarter of 2019 (Press release, Y-mAbs Therapeutics, NOV 13, 2019, View Source [SID1234551145]).

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"We are very pleased with our third quarter results, highlighted by prudent spending combined with notable progress in the preparation of our BLAs for naxitamab and omburtamab, as well commercial ramp-up for the potential launch of both compounds. In addition, we succesfully completed a follow-on offering in November, securing gross proceeds of $143.8 million, which we believe will – together with our existing cash – be sufficient to cover our operating costs through 2022," stated Thomas Gad, Founder, Chairman, President and Head of Business Development and Strategy.

Dr. Claus Moller, Chief Executive Officer, continued, "Over the third quarter, we have continued to work hard to make sure that our lead product candidates, naxitamab and omburtamab, advance towards rolling BLA submissions. We still expect the first portion of the rolling BLA for naxitamab to be submitted within the next few weeks, and we expect to file our BLA submission for omburtamab either via a rolling submission to begin in 2019 or early 2020 or via a single submission ahead of our expected completion date at the end of the first quarter of 2020.

Third Quarter 2019 and Recent Corporate Developments

Subsequent to the end of the third quarter, on November 1, 2019, Y-mAbs announced the pricing of a follow-on shelf public offering, resulting in gross proceeds to the Company of approximately $143.8 million.

·Also, subsequent to the end of the third quarter, on November 1, 2019, Y-mAbs announced that the requested omburtamab pre-BLA meeting with the FDA, had been converted to a general guidance meeting. Y-mAbs still expects to complete the omburtamab BLA submission by the end of the first quarter of 2020, and believes that the overall commercialization timeline will not be affected.

·Also, subsequent to the end of the third quarter, on October 28, 2019, Y-mAbs announced an update on omburtamab data, which was presented at the Interntional Society of Pediatric Oncology conference.

·After the close of the third quarter, on October 25, 2019, Y-mAbs announced an update on naxitamab data, which was presented at the Interntional Society of Pediatric Oncology conference.

On August 30, 2019, Y-mAbs announced the acceptance of abstracts concerning DSRCT for presentation at the Connective Tissue Oncology Society (CTOS) Annual Meeting for omburtamab.

· On July 8, 2019, Y-mAbs announced that it had completed a successful pre-BLA meeting with the FDA regarding a potential pathway for FDA approval of naxitamab for the treatment of relapsed/refractory high-risk neuroblastoma. During the meeting, the Company reached alignment with the FDA on an Accelerated Approval Pathway for naxitamab along with a rolling BLA submission.

· On July 1, 2019, Y-mAbs announced the status of patient recruitment for the Company’s two pivotal phase II trials, one for omburtamab for the treatment of central nervous system/leptomeningeal metastasis (CNS/LM) from neuroblastoma and the other for naxitamab for the treatment of relapsed/refractory high-risk neuroblastoma.

· Also, on July 1, 2019, Y-mAbs announced that the Company has entered into a development, manufacturing and supply agreement with SpectronRx in South Bend, Indiana, to secure access to clinical and commercial scale radiolabeling capacity for omburtamab. Under the terms of the agreement, SpectronRx has agreed to establish a manufacturing unit designated for Y-mAbs within its existing

facilities, at which Y-mAbs believes both clinical and commercial supply of radiolabeled omburtamab can be produced.

Third Quarter 2019 Financial Results

Y-mAbs reported a net loss of $23.9 million, or $0.70 per basic and diluted share, for the three months ended September 30, 2019, compared to a net loss of $11.4 million, or $0.42 per basic and diluted share, for the three months ended September 30, 2018.

For the nine months ended September 30, 2019, Y-mAbs reported a net loss of $57.9 million, or $1.69 per basic and diluted share, compared to a net loss of $29.2 million, or $1.08 per basic and diluted share, reported for the nine months ended September 30, 2018.

Operating Expenses

Research and Development

Research and development expenses were $19.7 million for the three months ended September 30, 2019, compared to $8.7 million for the three months ended September 30, 2018, an increase of $11.0 million. The increase in research and development expenses primarily reflects the following:

·$7.3 million increase in outsourced manufacturing for our two lead product candidates, naxitamab and omburtamab;

· $1.5 million increase in outsourced research and supplies to support expanding development activities; and

· $0.7 million increase in personnel costs.

Research and development expenses were $46.7 million for the nine months ended September 30, 2019, compared to $23.2 million for the nine months ended September 30, 2018, an increase of $23.5 million. The increase in research and development expenses primarily reflects the following:

· $14.5 million increase in outsourced manufacturing for our two lead product candidates, naxitamab and omburtamab;

· $5.0 million increase in outsourced research and supplies to support expanding development activities; and

·$1.9 million increase in personnel costs.

General and Administration

General and administrative expenses were $4.7 million for the three months ended September 30, 2019, compared to $2.7 million for the three months ended September 30, 2018, an increase of $2.0 million. Such increase in general and administrative expenses primarily reflects the following:

· $0.8 million increase in personnel costs; and

·$0.6 million increase in commercial infrastructure.

General and administrative expenses were $12.6 million for the nine months ended September 30, 2019, compared to $5.9 million for the nine months ended September 30, 2018, an increase of $6.7 million. Such increase in general and administrative expenses primarily reflects the following:

·$3.6 million increase in personnel costs; and

· $1.4 million increase in commercial infrastructure costs.

Cash and Cash Equivalents

The Company had approximately $98.2 million in cash and cash equivalents as of September 30, 2019, compared to $147.8 million as of December 31, 2018. The decrease of $49.6 million was primarily attributable to the increased costs of operation as the Company prepares for its submission of rolling BLAs for naxitamab and omburtamab and the build-up of the Company’s commercial infrastructure.

Webcast and Conference Call

The Company will host a conference call today at 4:30 pm eastern time. To participate in the call, please dial 877-407-0792 (domestic) or 201-689-8263 (international) and reference the access code 13696442. A webcast will be available at: View Source