On November 14, 2019 AC Immune SA (NASDAQ: ACIU), a Swiss-based biopharmaceutical company with a broad clinical-stage pipeline focused on neurodegenerative diseases, reported that it will present at Jefferies 2019 London Healthcare Conference in London, UK, taking place November 20 – 21, 2019 (Press release, AC Immune, NOV 14, 2019, View Source [SID1234551309]).

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Prof. Andrea Pfeifer, Ph.D., CEO of AC Immune SA, will discuss the Company’s world-leading pipeline and Roadmap to Successful Therapies for Neurodegenerative Diseases, with a focus on its clinical programs targeting misfolded Tau protein. AC Immune is addressing the full spectrum of Tau pathology by detecting and inhibiting both early seeding and extracellular spreading of Tau with its internally discovered, best-in-class small molecule (Partner: Eli Lilly), antibody (Partner: Roche/Genentech) and vaccine (Partner: Janssen) therapies, as well as its highly specific Tau diagnostic agents (Partner: Life Molecular Imaging).

Jefferies 2018 London Healthcare Conference
Date: November 21, 2019 | 5:20 pm GMT
Format: Fireside chat
Presenter: Prof. Andrea Pfeifer, CEO, AC Immune

A webcast of the presentation will be available on the Events Page of AC Immune’s website and at the Jefferies 2018 Healthcare Conference website and will be active for 90 days following the event.

On November 14, 2019 ThermoGenesis Holdings, Inc. (Nasdaq: THMO) formerly known as Cesca Therapeutics Inc., a market leader in automated cell processing tools and services in the cell and gene therapy field, reported it will delay its third quarter ended September 30, 2019 earnings release and subsequent earnings conference call, previously scheduled for today to Tuesday, November 19, 2019 (Press release, Thermogenesis, NOV 14, 2019, View Source [SID1234551327]). A conference call and webcast will follow at 1:30 p.m. PT/ 4:30 p.m. ET. The company will file a Form 12B-25 with the Securities Exchange Commission to extend its filing deadline for five calendar days until Tuesday, November 19, 2019 for its 10-Q third quarter report. As long as the company files the third quarter 10-Q within the five-day grace period, the report is deemed to have been filed timely by the Securities and Exchange Commission. The delay in filing is to allow for additional time to address complex accounting issues, including the completion of a third-party valuation related to the convertible note issued by the company in the quarter ended September 30, 2019.

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To participate in the conference call, please dial 1-844-889-4331 (domestic), 1-412-380-7406 (international) or 1-866-605-3852 (Canada). To access a live webcast of the call, please visit: View Source

A replay of the call will be available until December 10 and can be accessed by dialing 1-877-344-7529 (domestic), 1-412-317-0088 (international) or 1-855-669-9658 (Canada) and referencing access code 10136101. The webcast will be available for three months.

On November 14, 2019 Cleveland BioLabs, Inc. (NASDAQ:CBLI) reported financial results and development progress for the third quarter ended September 30, 2019 (Press release, Cleveland BioLabs, NOV 14, 2019, View Source [SID1234551294]).

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Cleveland BioLabs reported a net loss of $(0.4) million, excluding minority interests, for the third quarter of 2019, or $(0.04) per share, compared to a net loss, excluding minority interests, of $(1.1) million, or $(0.10) per share, for the same period in 2018. The decrease in net loss was primarily due to reduced Research and Development expenses and a decrease in General and Administrative costs, partially offset by a decrease in the non-cash adjustment to our warrant liabilities.

As of September 30, 2019, the Company had $1.9 million in cash, cash equivalents and short-term investments, which, based on the Company’s current operational plan, is expected to fund operations into September 2020.

As previously disclosed, in recent fiscal quarters, our research and development activity related to our development of entolimod as a treatment for acute radiation syndrome has declined as we were first awaiting the results of the bioequivalence study we undertook in response to the request of the Food and Drug Administration (the "FDA"), which study compared the historical drug formulation used in prior preclinical and clinical studies with the to-be-marketed drug product lots. Thereafter, we were awaiting the FDA’s confirmation that it agreed with our findings on bioequivalence, without which agreement the FDA had indicated it would not move forward to consider our pre-Emergency Use Authorization ("pre-EUA") application.

Since our submission of the bioequivalence study results, we have not received what we believe is a complete and fully satisfactory response from the FDA. Accordingly, we have been in ongoing discussions with the FDA, but our management has not been pleased with the pace or results of these discussions. We are therefore actively seeking ways to accelerate the FDA’s review and/or elevate within the management hierarchy of the FDA its consideration of our pre-EUA application.

Yakov Kogan, Ph.D., MBA, Chief Executive Officer, stated, "The pursuit of regulatory approval and commercialization for entolimod as a medical radiation countermeasure remains our main priority and focus."

Further Financial Results

Revenue for the third quarter of 2019 decreased to $0.27 million compared to $0.28 million for the third quarter of 2018. The net decrease was primarily attributable to decreased revenue from our service contract with Incuron, partially offset by increased revenue from our Joint Warfighter Medical Research Program ("JWMRP") contract from the Department of Defense ("DoD") for the continued development of the entolimod as a medical radiation countermeasure.

Research and development costs for the third quarter of 2019 decreased to $0.26 million compared to $0.84 million for the third quarter of 2018. The reduction in research and development costs is due to a $0.26 million decrease in expenses related to the oncology applications of the entolimod family of compounds, a $0.18 million decrease in spending for biodefense applications of entolimod, and a $0.14 million decrease in expenses related to curaxins.

General and administrative costs for the third quarter of 2019 decreased to $0.53 million compared to $0.71 million for the third quarter of 2018. This decrease was primarily attributable to a $0.11 million decrease in CBLI’s legal and professional fees related to the GPI investment in 2018 and a $0.04 million decrease in property taxes.

On November 14, 2019 Trillium Therapeutics Inc. ("Trillium" or the "Company") (NASDAQ/TSX: TRIL), a clinical stage immuno-oncology company developing innovative therapies for the treatment of cancer, reported financial results for the nine months ended September 30, 2019, and provided a corporate update (Press release, Trillium Therapeutics, NOV 14, 2019, View Source [SID1234551310]).

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"Over the past two months, we have conducted an intensive review of our development programs and resources," said Jan Skvarka, President and Chief Executive Officer of Trillium. "As a result of this review, we plan to focus our near term clinical development efforts on the intravenous administration of TTI-621, our anti-CD47 product that has shown promising preliminary evidence of activity in a number of hematologic malignancies. We continue to make progress in the ongoing dose escalation trial of TTI-621, with the goal of identifying the recommended phase 2 dose. As the only anti-CD47 molecule that has demonstrated complete responses in patients receiving study treatment as a monotherapy, TTI-621, we believe, has the potential to be the best-in-class molecule."

"Our recently announced corporate restructuring is intended to extend our runway and enable the focus on intravenous TTI-621," continued Mr. Skvarka. "In addition, we are exploring a number of strategic alternatives to maximize shareholder value."

STING Agonist Program Update

The Company presented updated preclinical data from its STING program at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) annual meeting in Washington, D.C, on November 9, 2019. The data demonstrate that TTI-10001, the Company’s lead small molecule STING agonist, is well tolerated in mice by intravenous and oral administration, and induces durable complete regressions of tumors and immunologic memory by both routes of administration. These data highlight the potential of TTI-10001 to achieve best-in-class status among next generation (non-cyclic dinucleotide) STING agonists. The Company is currently seeking a partner for further development of this molecule.

Third Quarter 2019 Financial Results:

As of September 30, 2019, Trillium had a combined cash and cash equivalents and marketable securities balance of $36.2 million, compared to $45.4 million at December 31, 2018. The September 30, 2019 working capital balance was $23.4 million, compared to $34.2 million at December 31, 2018. The decrease in cash and cash equivalents and marketable securities, and the decrease in working capital were due mainly to cash used in operations, partially offset by the cash received from the February 2019 public offering.

Net loss for the nine months ended September 30, 2019 of $29.8 million was lower than the loss of $33.9 million for the nine months ended September 30, 2018. The net loss was lower due mainly to a net warrant liability revaluation gain of $6.6 million and lower clinical trial related expenses, which were partially offset by a net foreign currency loss of $0.8 million in the current year compared to a net foreign currency gain of $1.5 million in the prior year and higher manufacturing costs. The Company also incurred an impairment loss in the three months ended September 30, 2019 of $3.9 million on the write down of the intangible asset related to the Fluorinov small molecule legacy programs acquired in 2016, as a result of the discontinuation of discovery research activities in the October 2019 restructuring and revised expected realization from Fluorinov legacy products.

On November 14, 2019 LUNGevity, the nation’s leading lung cancer-focused nonprofit organization, reported that features the stories of lung cancer survivors and their families in its Inhale for Life: Clinical Trials public service campaign launched during Lung Cancer Awareness Month (Press release, LUNGevity Foundation, NOV 14, 2019, View Source [SID1234551330]). This powerful social media video series aims to educate and encourage people living with lung cancer to explore treatment options that may be available to them through clinical trials.

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Experience the interactive Multichannel News Release here: View Source

Given the rapidly evolving therapeutic and diagnostic options available in lung cancer, clinical trials can provide a potential treatment option for lung cancer patients today. Trials are a critical resource for the discovery of new treatment methods for cancer, yet many people are unaware of them and the potential benefits they may receive by participating. Further, the treatment options available today would not have been possible without clinical trials and the patients who participated in them. Inhale for Life: Clinical Trials campaign stresses the importance of clinical trials and is designed to spread awareness to lung cancer patients and their families.

"The field of lung cancer research and patient care is accelerating at an exciting and truly remarkable pace," says Andrea Ferris, President and CEO of LUNGevity Foundation. "More people live well with lung cancer today than ever before, and that is very good news, but, with more than 228,000 people expected to be diagnosed this year, we still have a long way to go. Our goal with Inhale for Life: Clinical Trials is to reach as many people as possible diagnosed with lung cancer and educate them about the importance and benefits of clinical trials."

Lung cancer is the second most commonly diagnosed cancer in the world, with more than 1.8 million new cases diagnosed every year. Nearly 65% of all new diagnoses are nonsmokers. Today, through advancements in research, many lung cancer patients are living longer and better lives. Yet, the disease often goes undetected until late stages when it is harder to treat. LUNGevity is proud of its impact on improving outcomes for lung cancer patients through a better understanding of diagnosis, treatment, and quality of life, as well as through driving research and policy reforms.

Videos in the Inhale for Life: Clinical Trials series stress the importance of clinical trials and their potential role in the clinical care of patients. Thanks to the medical advances available through clinical trials, the lung cancer survivors featured are able to continue to live and thrive, from working high-level corporate jobs to celebrating milestones in the lives of their children and grandchildren; their lives kindles new hope for progress in lung cancer treatment and their participation helps demonstrate safety and efficacy of new drugs for future patients. While clinical trials may not be appropriate for all patients, the videos encourage viewers to talk to their doctor to see if a clinical trial could be right for them.

LUNGevity strives to ensure that all people diagnosed with lung cancer have access to optimal care and support to help them live their best lives possible. Because clinical trials can at times be the best treatment options available for some patients, LUNGevity advocates for access to trials so that all patients who are eligible can participate. LUNGevity provides support services to provide information to those considering a clinical trial, such as Clinical Trial Ambassadors, a peer-to-peer trial buddy matching service that pairs lung cancer clinical trial participants with someone who is considering participation, to provide encouragement and offer experiential insights.

A Clinical Trial Finder helps people find available clinical trials by type of lung cancer and geographic location. LUNGevity’s Scientific and Clinical Roundtable convenes multi-stakeholder participants, including regulators, industry leaders, clinicians and patients, and focuses on defining and then achieving ideal patient-centric, efficient, clinical trials and therapy development paradigms for lung cancer.

The Inhale for Life: Clinical Trials campaign is supported in part by grants from Amgen Oncology, Bristol-Myers Squibb, EMD Serono, and Genentech. The campaign can be seen at View Source