INmune Bio, Inc. Reports Third Quarter 2019 Financial Results and Provides Shareholder Update

On November 8, 2019 INmune Bio, Inc. (NASDAQ: INMB) (the "Company"), an immunology company developing treatments that harness the patient’s innate immune system to fight disease, reported its financial results for the third quarter ended September 30, 2019 and is providing a business update (Press release, INmune Bio, NOV 8, 2019, View Source [SID1234551121]).

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Q3 2019 and Recent Highlights:

·Launched NeuLiv(TM) program for the treatment of NASH
.Presented data related to lead compound XPro1595 at the Society for Neuroscience’s annual meeting
·Announced a potential link between obesity and Alzheimer’s Disease at the Society for Neuroscience 49th annual meeting: Dr. Malú Tansey’s new data was highlighted at the corresponding press conference
·Announced USPTO Allowance of Key Patent Covering the Company’s DN-TNF Platform Technology for Treating Cancer
·Presented XPro1595 for Treating Neuroinflammation in Alzheimer’s Disease at 2019 Alzheimer’s Association International Conference (AAIC) Satellite Symposium
·Invited to present at industry meetings in the US and EU including Targeting Innate Immunity Congress, Inflammasome Therapeutics Summit and Markets&Markets Next Gen Immuno-Oncology Congress
"During the quarter we advanced our existing programs and expanded our pipeline of therapies reprograming the innate immune system to fight disease," stated RJ Tesi, M.D., Chief Executive Officer of INmune Bio. "For our existing pipeline, we are looking to the up-coming Phase II trials for INB03 and Phase 1 trials of INKmune(TM) in Cancer and XPro1595 for Alzheimer’s Disease. Also, we expanded our pipeline with the launch of our NeuLiv(TM) program for the treatment of NASH which we expect to start a Phase 2a trial next year. Looking ahead, the team at INmune Bio is focused on executing against our upcoming milestones to maximize shareholder value."

Upcoming Milestones:

·4Q19 – First patient enrolled XPro1595 Alzheimer’s Disease trial
·1H20 – Initiate INB03 Phase II cancer trial
·2H20 – Initiate NeuLiv(TM) Phase IIa trial in NASH
·2H20 – First patient enrolled INKmune(TM) cancer trial
·2H20 – Phase I data on Alzheimer’s Disease XPro1595 AD data
·Financial Results for the Third Quarter Ended September 30, 2019:
Net loss attributable to common stockholders for the third quarter ended September 30, 2019 was $3.1 million, compared to $1.5 million for the quarter ended September 30, 2018.

Research and development expense totaled approximately $1.2 million for the third quarter ended September 30, 2019, compared with approximately $0.7 million for the quarter ended September 30, 2018. Research and development expenses increased during the three months ended September 30, 2019 as a result of the further advancement of our drug platforms.

General and administrative expense was approximately $1.9 million in the quarter ended September 30, 2019, compared to approximately $0.9 million in the quarter ended September 30, 2018. The $1.0 million increase in general and administrative expense is largely due to costs associated with being a public company.

At September 30, 2019, the Company had cash and cash equivalents of approximately $7.4 million with no debt. During October 2019, the Company received $0.4 million of cash proceeds from Australia pursuant to a research and development tax credit.

As of November 8, 2019, the Company had 10.8 million common and 13.9 million fully diluted shares outstanding.

Cerus Corporation to Present at the Stephens Nashville Investment Conference

On November 8, 2019 Cerus Corporation (Nasdaq:CERS) reported that Kevin D. Green, Cerus’ chief financial officer, will present at the Stephens Nashville Investment Conference on Wednesday, November 13, 2019 at 10:30 a.m. CT (Press release, Cerus, NOV 8, 2019, View Source [SID1234550748]).

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A live webcast of the presentation will be available on the Investor Relations page of the Cerus web site at View Source A replay of the webcast will be available for approximately two weeks following the completion of the event.

TG Therapeutics to Host Conference Call on Third Quarter 2019 Financial Results and Business Update

On November 8, 2019 TG Therapeutics, Inc. (NASDAQ: TGTX), reported that a conference call will be held, Tuesday, November 12, 2019 at 8:30 AM ET to discuss results for the third quarter of 2019 and provide a business outlook for the remainder of the year (Press release, TG Therapeutics, NOV 8, 2019, http://ir.tgtherapeutics.com/news-releases/news-release-details/tg-therapeutics-host-conference-call-third-quarter-2019 [SID1234550765]). Michael S. Weiss, the Company’s Executive Chairman and Chief Executive Officer will host the call.

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In order to participate in the conference call, please call 1-877-407-8029 (U.S.), 1-201-689-8029 (outside the U.S.), Conference Title: TG Therapeutics Third Quarter 2019 Business Update Call. A live audio webcast will be available on the Events page, located within the Investors & Media section, of the Company’s website at View Source An audio recording of the conference call will also be available for replay on the Company’s website, for a period of 30 days after the call.

TG Therapeutics will announce its financial results for this period in a press release to be issued prior to the call.

BioInvent to Present BI-1206 Preclinical Data in Mantle Cell lymphoma at ASH 2019

On November 8, 2019 BioInvent International AB (publ) (OMXS: BINV) reported it will make a poster presentation with preclinical data on BI-1206 at the annual American Society of Hematology (ASH) (Free ASH Whitepaper) meeting in Orlando, Florida held December 7-10 (Press release, BioInvent, NOV 8, 2019, View Source [SID1234550797]).

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The abstract, published here, highlights a preclinical study of BI-1206 in an ibrutinib-venetoclax dual resistant PDX model derived from a doubly-resistant mantle cell lymphoma (MCL) patient. Single agent BI-1206 had potent anti-MCL activity in the FcγRIIb-expressing MCL PDX model to overcome ibrutinib-venetoclax dual resistance.

FcγRIIb was further shown to be highly expressed in 27/27 primary patient MCL samples examined. Along with previously published data demonstrating an important role for FcγRIIB in resistance to rituximab-based cancer immunotherapy, and BI-1206 in boosting rituximab efficacy and overcoming rituximab-resistance, these data indicate the significant potential of BI-1206 to address a significant unmet need in MCL and hematologic malignancy.

BioInvent CEO Martin Welschof said: "These pre-clinical data indicate a broad and clinically important role of FcγRIIb in mantle cell lymphoma, and highlight the potential of BI-1206 to help overcome resistance in this indication. This further reinforces our belief that FcγRIIb will become a key element for treating hematological and solid malignancies, and the potential of BI-1206 to play an important role in combating these diseases."

BI-1206, one of BioInvent’s proprietary anti-FcyRIIB antibodies and its lead compound, is currently being investigated in clinical trials in non-Hodgkin lymphoma, chronic lymphocytic leukemia and solid tumors.

Details of the poster:

Title: BI-1206, a Monoclonal Antibody Against FcyRIIIb, Showed Superior Anti-Tumor Activity in an Ibrutinib-Venetoclax Dual Resistant PDX Model in Mantle Cell Lymphoma

Session Name: 625. Lymphoma: Pre-Clinical-Chemotherapy and Biologic Agents: Poster II

Time: Sunday, December 8, 2019, 6:00 – 8:00 PM

Location: Orange County Convention Center, Hall B

Ultragenyx to Present at Upcoming Investor Conferences

On November 8, 2019 Ultragenyx Pharmaceutical Inc. (NASDAQ: RARE), a biopharmaceutical company focused on the development of novel products for serious rare and ultra-rare genetic diseases, reported upcoming presentations at the following conferences (Press release, Ultragenyx Pharmaceutical, NOV 8, 2019, View Source [SID1234550749]):

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Emil D. Kakkis, M.D., Ph.D., the company’s Chief Executive Officer and President, will present at the Credit Suisse 28TH Annual Healthcare Conference on Tuesday, November 12, 2019 at 11:30 AM MT in Scottsdale, Arizona.

Tom Kassberg, the company’s Chief Business Officer, will present at the Stifel Healthcare Conference on Wednesday, November 20, 2019 at 1:50 PM ET in New York, NY.
The live and archived webcast of the company presentations will be accessible from the company’s website at View Source The replay of the webcast will be available for 90 days.