INmune Bio Reports Second Quarter 2019 Financial Results and Provides Shareholder Update

On August 13, 2019 INmune Bio, Inc. (NASDAQ: INMB) (the "Company"), an immunology company focused on developing treatments that harness the patient’s innate immune system to fight disease, reported its financial results for the second quarter ended June 30, 2019 and is providing a business update for the year-to-date (Press release, INmune Bio, AUG 13, 2019, View Source [SID1234538726]).

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2019 Year-to-Date Corporate Highlights:

·INmune Bio’s management team rang the NASDAQ closing bell on Tuesday, April 9, 2019, to celebrate the Company’s successful initial public offering ("IPO") in February 2019.
·In May, the Company closed a private placement of approximately $4.7M of Common Stock priced led by Insiders and existing shareholders.
·The Company published data on INmune Bio’s INB16 (INKmune) cell line in peer-reviewed journal PLOS ONE.
·Reported positive preliminary data from INB03 Phase I clinical trial in cancer followed by a final report later this year as the Company advances the program into a Phase II study.
·Edguardo (Ed) Baracchini a biotech business development veteran joined the board of directors.

"This year we remained focused on advancing our pipeline," stated RJ Tesi, M.D., Chief Executive Officer of INmune Bio. "More recently we announced we have begun planning a Phase II trial for INB03 after receiving positive preliminary data from its clinical Phase I study. This preliminary data has allowed us to move forward with the development of INB03 as a combination immunotherapy for patients with cancer. We anticipate our full data set to be reported later this year followed by a Phase II study."

Our clinical programs continue to advance:

·Received preliminary positive data on INB03’s Phase I study in patients with advanced solid tumors. The trial was successful in determining, in order of priority, the safety of INB03 in cancer patients, the adequate dosage of INB03, and evidence of a biologic effect, as the Company begins planning a Phase II trial in cancer patients using INB03 as part of their combination immunotherapy. The target INB03 trough level was reached in three of three patients in the 1.0 mg/kg group. The inflammatory cytokine IL6, a biomarker of soluble TNF function, decreased by more than 50% in half of the patients, suggesting a pharmacodynamic effect of INB03.

·INmune anticipates it will start patient enrollment in the Phase I study of XPro1595 for the treatment of Alzheimer’s disease and INKmune, INmune Bio’s NK cell therapy focused on eliminating residual disease after cancer therapy, in the second half of 2019.

Financial Results for the Second Quarter Ended June 30, 2019:

Net loss attributable to common stockholders for the second quarter ended June 30, 2019 was $0.4 million, compared to $6.2 million for the quarter ended June 30, 2018. Net loss incurred during the quarter ended June 30, 2019 included a noncash waiver of common stock issuable of $1.5 million partially offset by noncash stock-based compensation expense of $1.0 million.

Research and development expense totaled approximately $0.3 million for the second quarter ended June 30, 2019, compared with approximately $0.3 million for the quarter ended June 30, 2018. During the three months ended June 30, 2019, research and development expense included $0.6 million of research and development expense related to clinical trials, partially offset by $0.3 million of grants from the Alzheimer’s Association which the Company recognized as contra research and development expense.

General and administrative expense was approximately $1.7 million in the quarter ended June 30, 2019, compared to approximately $5.9 million in the quarter ended June 30, 2018. The $4.2 million decline in general and administrative expense is due to lower noncash stock-based compensation ($1.0 million for the quarter ended June 30, 2019 compared to $5.6 million for the quarter ended March 31, 2018), partially offset by higher general and administrative expenses including investor relations and payroll expense.

At June 30, 2019, the Company had cash and cash equivalents of approximately $9.4 million with no debt. In May, the Company closed a private placement of approximately $4.7 million of Common Stock led by insiders and existing shareholders.

As of August 9, 2019 the Company had 10.8 million common and 13.9 million fully diluted shares outstanding.

Adaptive Biotechnologies Corporation Reports Second Quarter 2019 Financial Results

On Augsut 13, 2019 Adaptive Biotechnologies Corporation ("Adaptive Biotechnologies") (Nasdaq: ADPT) reported financial results for the quarter ended June 30, 2019 (Press release, Adaptive Biotechnologies, AUG 13, 2019, View Source [SID1234538720]).

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"At Adaptive, we are translating the genetics of the adaptive immune system into clinical products to transform the diagnosis and treatment of disease," said Chad Robins, chief executive officer and co-founder of Adaptive. "We are making important progress across on key catalysts that will enable near-term product applications across our life sciences research, clinical diagnostics, and drug discovery businesses, unlocking one of the largest global addressable markets in healthcare."

Recent Highlights

Revenue of $22.1 million for the second quarter of 2019, an increase of 91% over the second quarter of 2018

Secured network participation agreements and/or positive medical policies with several national payors for the use of clonoSEQ to detect and assess minimal residual disease, bringing the total number of covered lives to more than 165 million

Received approval for the clonoSEQ Assay from the State of New York Clinical Laboratory Evaluation Program, or CLEP, for the detection and monitoring of MRD in patients with certain blood cancers using DNA from bone marrow, blood and archived tissue samples

Opened a high throughput lab dedicated to rapid generation of clinical signals for immunoSEQ Dx, leveraging the Company’s collaboration with Microsoft

Completed initial public offering, raising approximately $321 million of net proceeds, after deducting underwriting discounts and commissions

Second Quarter 2019 Financial Results

Revenue was $22.1 million for the quarter ended June 30, 2019, representing a 91% increase from the second quarter in the prior year. Sequencing revenue was $11.9 million for the quarter, representing a 43% increase from the second quarter in the prior year. Development revenue increased to $10.3 million for the quarter, representing a 213% increase from the second quarter in the prior year.

Operating expenses were $38.2 million for the second quarter of 2019, compared to $24.9 million in the second quarter of the prior year, representing an increase of approximately 54%.

Net loss was $15.7 million in the second quarter of 2019, compared to $12.5 million in the same period in 2018.

Adjusted EBITDA (non-GAAP) was a loss of $10.9 million for the second quarter of 2019, compared to a loss of $9.4 million in the second quarter of the prior year.

Cash, cash equivalents and marketable securities was $423.0 million as of June 30, 2019. Subsequent to the end of the quarter, on July 1, 2019, Adaptive Biotechnologies completed its initial public offering, raising approximately $321 million of net proceeds, after deducting underwriting discounts and commissions.

2019 Financial Guidance

Management will provide its 2019 revenue outlook on the conference call scheduled to discuss the Company’s second quarter 2019 financial results.

Webcast and Conference Call Information

Adaptive Biotechnologies will host a conference call to discuss its second quarter 2019 financial results after market close on Tuesday, August 13, 2019 at 4:30 PM Eastern Time. The conference call can be accessed live over the phone (800) 361-2311 for U.S. callers or (409) 937-8761 for international callers (Conference ID: 3095467). The webcast can be accessed at View Source

Crinetics Pharmaceuticals Reports Second Quarter 2019 Financial Results and Provides Corporate Update

On August 13, 2019 Crinetics Pharmaceuticals, Inc. (Nasdaq: CRNX), a clinical stage pharmaceutical company focused on the discovery, development and commercialization of novel therapeutics for rare endocrine diseases and endocrine-related tumors, reported financial results for the quarter ended June 30, 2019 and provided an update on its corporate activities and product pipeline (Press release, Crinetics Pharmaceuticals, AUG 13, 2019, View Source [SID1234538716]).

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"This July marks the end of a full year as a public company for Crinetics and we are excited by the progress we made this past quarter, and our evolution during the past year," said Scott Struthers, Ph.D., Founder and Chief Executive Officer of Crinetics. "As the ACROBAT trials continue to enroll patients with acromegaly, we are progressing the rest of our pipeline, as highlighted by the initiation of our Phase 1 trial for CRN01941 aimed at neuroendocrine tumors and are making strides with our preclinical programs for Cushing’s Disease and congenital hyperinsulinemia."

Second Quarter and Subsequent Highlights

Initiated Phase 1 study of CRN01941 for the treatment of neuroendocrine tumors. In May 2019, Crinetics initiated a Phase 1, double blind, randomized, placebo-controlled, single- and multiple-dose study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of CRN01941 in healthy volunteers with topline data expected in late 2019 or early 2020. CRN01941 is an oral nonpeptide somatostatin receptor subtype 2 (sst2) biased agonist designed for the treatment of neuroendocrine tumors (NETs) that originate from neuroendocrine cells commonly found in the gut, lung, or pancreas.

Received final award of SBIR grant from NIH for congenital hyperinsulinism. In July 2019, Crinetics announced that it would receive up to approximately $0.9 million in continued funding under its Small Business Innovation Research (SBIR) grant from the National Institute of Diabetes and Digestive and Kidney diseases (NIDDK) of the National Institutes of Health (NIH). The funds are being used to support the ongoing research and development of Crinetics’ nonpeptide somatostatin agonists for congenital hyperinsulinemias (CHI).

Expanded board of directors. In July 2019, Crinetics appointed Stephanie S. Okey, M.S. to its board of directors as an independent board member. Ms. Okey brings extensive leadership and management experience having spent her career in senior commercial roles including, most recently, Head of North America and U.S. General Manager of Rare Diseases at Genzyme.

Second Quarter 2019 Financial Results

Research and development expenses were $10.3 million for the three months ended June 30, 2019, compared to $5.2 million for the same period in 2018. The increases were primarily attributable to development and manufacturing activities for CRN00808 and CRN01941 as well as the company’s preclinical programs and higher personnel costs.

General and administrative expenses were $3.1 million for the three months ended June 30, 2019, compared to $1.1 million for the same period in 2018. The increases were primarily due to costs to operate as a public company, as well as personnel costs to support the company’s growth.

Net loss for the three months ended June 30, 2019 was $12.4 million, compared to a net loss of $5.6 million for the same period in 2018.

Unrestricted cash, cash equivalents and investments totaled $145.0 million as of June 30, 2019, compared to $157.2 million as of March 31, 2019 and $163.9 million as of December 31, 2018.

As of July 31, 2019, the company had 24,199,972 common shares outstanding.

DiaMedica Therapeutics Announces Second Quarter 2019 Financial Results and Provides Business Update

On August 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 six months ended June 30, 2019 (Press release, DiaMedica, AUG 13, 2019, View Source [SID1234538712]).

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Clinical Developments

DM199 for the Treatment of Chronic Kidney Disease

Enrollment Complete in Phase Ib Clinical Study in Patients with CKD

DiaMedica has completed enrollment and patient follow-up in its Phase Ib clinical trial of DM199 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.

As previously announced, interim results were positive. PK profiles, at the 3µg/kg dose level, were similar between moderate and severe CKD patients, and consistent with healthy subjects 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. Further, the Company believes that study results support the determination of a dose range to normalize KLK1 levels in CKD patients for its upcoming Phase II study work.

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%, eGFR, average increase of 4.08 mL/min/1732, and 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.

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 SAEs. AEs were minor and consistent with standard treatment(s) in the CKD patient population.

DiaMedica is currently collecting results from the final four study subjects and expects to provide full results of the study in a peer-reviewed publication and/or poster presentation.

Phase II Clinical Study in IgA Nephropathy and African Americans with Hypertension and CKD

The Company has submitted a protocol to the U.S. Food and Drug Administration for its Phase II, multiple cohort study in patients with CKD caused by rare or significant unmet diseases. This study is anticipated to start in the second half of 2019. The target causes for two cohorts are IgA Nephropathy and Hypertensive African Americans with CKD.

One cohort is expected to enroll 30 subjects previously diagnosed with CKD caused by IgA nepropathy ("IgAN"). IgAN is a kidney disease that occurs when pathogenic immunoglobulin A (IgA) builds up in a patient’s kidney resulting in mesangial depositions causing inflammation and impairing the kidney’s filtration abilities. Approximately 140,000 people in the US suffer from IgAN, making it a rare disease, with no approved treatments. DM199 has the potential to treat IgAN through increasing Tregs, addressing the underlying autoimmune problems of IgAN, and thereby improving overall kidney function. The Company anticipates that a Phase III trial, based on other products currently in development, will require 200-400 subjects treated for 9 to 12 months for initial approval.

An additional cohort will enroll 30 hypertensive, non-diabetic African Americans with CKD, including both those with and without the APOL1 gene mutation. The APOL1 gene mutation accounts for a significant increase in the risk for chronic and end stage kidney disease in this patient population. There are approximately 7 million African Americans with CKD in the U.S. and they are three to four times more likely to suffer kidney failure than Caucasians. African Americans with the CKD and the APOL1 gene mutation (~15% of African American population) are two times more likely to progress into end stage renal disease than African Americans without the APOL1 gene. African Americans with CKD exhibit lower levels of KLK1, reduced renal blood flow and, 73% of those that are hypertensive, are salt sensitive, meaning less able to regulate sodium and potassium levels in the body; DM199 has the potential to be a successful treatment given its ability to replenish KLK1 levels and restore the function of the KKS, the results of which improve renal blood flow and regulation of sodium/potassium levels. KLK1 has also been shown to be more effective in salt sensitive pre-clinical models. There are currently no approved therapies for African Americans with CKD.

"We are pleased with the the results from our CKD Phase 1b study which confirmed the safety, tolerability and consistent PK of DM199," commented Dr. Harry Alcorn, DiaMedica’s Chief Medical Officer. "This 32 patient study completed without any significant adverse events consistent with prior studies and further confirms the safety profile of DM199 and established a sound basis for determing dose levels for our upcoming Phase II study."

DM199 for the Treatment of Acute Ischemic Stroke

DM199 Acute Ischemic Stroke Phase II "REMEDY" Trial Update

The REMEDY trial continues to enroll subjects and there have been no drug-related serious adverse events. Enrollment has passed the two-thirds mark and is continuing at 12 sites and the Company expects to complete this trial in the fourth quarter of 2019 or first quarter of 2020.

In the REMEDY trial, study drug (DM199 or placebo) is administered as an intravenous ("IV") infusion within 24 hours of stroke symptom onset, followed by SC injections later that day and once every 3 days for 21 days (8 SC doses). Multiple plasma-based biomarkers (e.g. C-reactive protein), the Modified Rankin Scale, National Institutes of Health Stroke Scale and the Barthel Index are assessed at multiple points throughout the study, including 90 days post-stroke. This study also includes additional tests to further investigate DM199’s therapeutic potential.

"We are very pleased to have completed the enrollment in our Phase Ib study in CKD patients and with the continued progress of the enrollment in our REMEDY Phase II study," stated Rick Pauls, DiaMedica’s President and CEO. "With the submission of the protocol for our Phase II study in CKD, we are excited to turn our attention to engaging study sites and once again, we also wish to extend our sincere gratitude to the study sites, physician investigators and study subjects for their support in completing our Phase Ib study of DM199 for patients suffering from chronic kidney disease."

Advancing American Kidney Health Initiative

On July 10, President Donald Trump signed an executive order to launch Advancing American Kidney Health, a new initiative to improve the lives of Americans suffering from kidney disease. This groundbreaking proposal is focused on improving outcomes, lowering health system costs and offering quality-of-life benefits for patients with CKD. CKD impacts the lives of more than 30 million Americans; of those, more than 700,000 have end stage renal disease ("ESRD"), or kidney failure, and require dialysis treatment or an organ transplant to survive. The first goal identified in the executive order is a 25% reduction in the number of Americans developing ESRD by 2030. DiaMedica believes that DM199 may become an important treatment for CKD and may provide doctors an important therapeutic option to directly treat CKD and assist in reducing the number of patients progressing to ESRD.

DiaMedica Regains Worldwide Rights for DM199 for Acute Ischemic Stroke

In September 2018, the Company licensed DM199 for the clinical development and commercialization of DM199 for the treatment of acute ischemic stroke in China to Ahon Pharmaceutical Co Ltd (Ahon Pharma). On August 12, 2019, after extensive good faith discussions between Ahon Pharma and the Company, the parties were unable to agree upon mutually acceptable revised terms to the agreement and DiaMedica terminated this license agreement due to Ahon Pharma’s non-payment of the milestone due upon the earlier of regulatory clearance to initiate a clinical trial in China or July 1, 2019. As a result of this termination, DiaMedica has regained worldwide rights for DM199 for acute ischemic stroke.

Despite the non-receipt of this milestone payment, the Company expects its current cash resources to be sufficient to allow it to complete the first two cohorts in the Phase II CKD study and the Phase II study in AIS and fund its planned operations into the fourth quarter of 2020.

Financial Results

Research and development expenses increased to $1.9 million for the three months ended June 30, 2019, up from $1.1 million for the three months ended June 30, 2018, an increase of $0.8 million. R&D expenses increased to $4.5 million for the six months ended June 30, 2019, compared to $1.9 million for the six months ended June 30, 2018, an increase of $2.6 million. The increase for the six months ended June 30, 2019, was due to costs of approximately $1.3 million incurred for a new production run of the DM199 drug substance, as well as costs incurred in conjunction with the Phase Ib clinical study in CKD patients and increased year over year costs for the REMEDY Phase II stroke study. Increased personnel costs also contributed to the increase.

General and administrative expenses were $867,000 for the three months ended June 30, 2019, compared to $780,000 for the three months ended June 30, 2018. G&A expenses increased to $1.7 million for the six months ended June 30, 2019, up from $1.3 million for the six months ended June 30, 2018. On a year-to-date basis, this increase was primarily due to costs associated with our status as a Nasdaq-listed U.S. public reporting company, which commenced in December 2018, and increased personnel costs, partially offset by a reduction in non-cash charges for share-based compensation.

Total other income increased to $280,000 for the three months ended June 30, 2019, up from $131,000 for the prior year period. Total other income decreased to $458,000 for the six months ended June 30, 2019, compared to $789,000 for the six months ended June 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 six months ended June 30, 2018. The current quarter other income primarily relates to increased study costs, compared to the prior year period, driving an increase in the related 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 six months ended June 30, 2019.

Balance Sheet and Cash Flow

The Company had cash and cash equivalents of $3.0 million, marketable securities of $8.0 million, current liabilities of $947,000 and working capital of $11.3 million as of June 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 six months ended June 30, 2019.

Net cash used in operating activities was $6.0 million for the six months ended June 30, 2019, compared to $2.0 million for the six months ended June 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 Wednesday, August 14, 2019, at 7:00 a.m. Central Time:

Date: Wednesday, August 14, 2019
Time: 7:00 AM CT
Web access: View Source
Dial In: (866) 962-3583 (domestic)
(630) 652-5857 (international)
Conference ID: 9274148
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 August 20, 2019, by dialing (855) 859-2056 (US Toll Free), (404) 537-3406 (International), replay passcode 9274148.

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 prostacyclin. 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 acute ischemic stroke and patients with chronic kidney disease.

Oncolytics Biotech(R) Announces Public Offering of Common Shares and Warrants

On August 13, 2019 Oncolytics Biotech Inc. (NASDAQ:ONCY) (TSX:ONC), currently developing pelareorep, an intravenously delivered immuno-oncolytic virus, reported that it intends to offer to sell common shares and warrants to purchase common shares in an underwritten public offering (the "Offering") (Press release, Oncolytics Biotech, AUG 13, 2019, View Source [SID1234538711]). The Company expects to grant the underwriter a 30-day option to purchase additional common shares and warrants to purchase common shares. The Offering is subject to market conditions, as well as NASDAQ and TSX approvals, and there can be no assurance as to whether or when the Offering may be completed, or the actual size or terms of the Offering.

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Ladenburg Thalmann & Co. Inc., a subsidiary of Ladenburg Thalmann Financial Services Inc. (NYSE American:LTS), is acting as the sole book-running manager in connection with the Offering.

The Company intends to use the net proceeds of the Offering for research and development activities and working capital purposes.

The Offering is being made pursuant to a U.S. registration statement on Form F-10, declared effective by the United States Securities and Exchange Commission (the "SEC") on May 7, 2018 (the "Registration Statement"), and the Company’s existing Canadian short form base shelf prospectus (the "Base Shelf Prospectus") dated May 4, 2018. The preliminary prospectus supplements relating to the Offering (together with the Base Shelf Prospectus and the Registration Statement, the "Offering Documents") will be filed with the Alberta Securities Commission in Canada, and with the SEC in the United States. No common shares or warrants will be offered or sold to Canadian purchasers. The Offering Documents will contain important detailed information about the securities being offered. Before you invest, you should read the Offering Documents and the other documents the Company has filed with the SEC for more complete information about the Company and the Offering. Copies of the Offering Documents will be available for free by visiting the Company’s profiles on the SEDAR website maintained by the Canadian Securities Administrators at www.sedar.com or the SEC’s website at www.sec.gov. Alternatively, when available, copies of the preliminary prospectus supplement can also be obtained from Ladenburg Thalmann & Co. Inc., Attn: Prospectus Department, 277 Park Avenue, 26th Floor, New York, New York 10172 or by email at [email protected]

This press release does not constitute an offer to sell or the solicitation of an offer to buy securities, nor will there be any sale of the securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such jurisdiction.