On November 14, 2019 Cardax, Inc. (OTCQB:CDXI) reported that results for the third quarter of 2019 (Press release, Cardax Pharmaceuticals, NOV 14, 2019, View Source [SID1234551333]). Highlights were as follows:

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CHASE Clinical Trial. On September 23, 2019, the Company announced results from the pre-specified interim review of its ongoing CHASE (Cardiovascular Health Astaxanthin Supplement Evaluation) clinical trial.

The CHASE clinical trial is a double-blind, randomized, placebo-controlled clinical trial evaluating the effect of the Company’s astaxanthin dietary supplement ZanthoSyn, on cardiovascular health, as measured by C-Reactive Protein or "CRP" levels over 12 weeks in up to 120 subjects with documented cardiovascular risk factors. Pre-specified secondary cardiovascular/inflammatory health markers, safety parameters, exploratory endpoints, and pre-specified sub-groups are also being assessed. The trial includes an optional open-label extension through 48 weeks.

The interim results were based on data from 40 subjects administered high dose ZanthoSyn (96 mg/day astaxanthin—48 mg twice a day), low dose ZanthoSyn (24 mg/day astaxanthin—12 mg twice a day), or placebo. The Company believes these encouraging findings provide:

Further mechanistic support for the Company’s astaxanthin pharmaceutical development program
Basis for additional patent filings
Support for the cardiovascular health benefits of ZanthoSyn*
View press release: Cardax Announces Interim Results from CHASE Clinical Trial, September 23, 2019

Intellectual Property. The Company filed additional patents to extend patent coverage in the U.S. and worldwide to 2039-2040, with such applications including coverage related to certain cardiovascular uses on the basis of the CHASE clinical trial results as well as coverage related to the composition of matter of CDX-101, the Company’s lead pharmaceutical candidate.

ZanthoSyn. Revenues rebounded in Q3 2019 with a more than five times increase compared to the previous quarter: $229,142 in Q3 2019 vs. $45,391 in Q2 2019. The rebound was driven by a return to normal inventory sell-in patterns, where "sell-in" is defined as wholesale orders of ZanthoSyn by General Nutrition Corporation ("GNC") less sales incentives, promotions, discounts, and refunds. Sell-through (retail sales of ZanthoSyn to GNC customers) also continued strong and the Company expects this trend to continue. ZanthoSyn is the top-selling product nationwide in GNC’s antioxidant category for 2019 year-to-date as well as the top-selling overall product in GNC’s Hawaii stores.

Financing. The Company raised $1,390,000 since the beginning of Q3 2019 to date, primarily via convertible notes, with the majority of this amount to automatically convert to equity upon a qualified financing of $5,000,000 or more. Net proceeds are being used for general working capital and to fund research, development, and clinical programs.

"We are very pleased with the encouraging CHASE trial interim results and our new patent filings. These milestones reflect the successful execution of key parts of our strategy to create value around our pharmaceutical development programs," said David G. Watumull, Cardax President and CEO. "On the consumer side of the business, the rebound in ZanthoSyn sales in Q3 2019 serves as an excellent foundation for Q4 2019 and Q1 2020."

On November 14, 2019 Lipocine Inc. (NASDAQ: LPCN), a clinical-stage biopharmaceutical company focused on metabolic and endocrine disorders, reported the pricing of a public offering of (i) 10,450,000 Class A Units, each consisting of shares of its common stock and common warrants to purchase its common stock, and (ii) 1,550,000 Class B Units, each consisting of pre-funded warrants and warrants to purchase its common stock, at a price of $0.50 per Class A Unit and $0.4999 per Class B Unit (Press release, Lipocine, NOV 14, 2019, View Source [SID1234551332]). Gross proceeds to the Company are expected to be approximately $6.0 million, before deducting placement agent fees and other estimated offering expenses. The Company intends to use the net proceeds from this offering for working capital and general corporate purposes.

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Roth Capital Partners is acting as sole agent for the public offering.

The offering is being made pursuant to a shelf registration statement on Form S-3 (File No. 333-220942) (including a prospectus) previously filed with and declared effective by the U.S. Securities and Exchange Commission (the "SEC"). A prospectus supplement describing the terms of the offering will be filed with the SEC.

A copy of the final prospectus supplement and the accompanying prospectus relating to these securities may be obtained, when available, by contacting Roth Capital Partners, 888 San Clemente Drive, Suite 400, Newport Beach, CA 92660, (800) 678-9147. Electronic copies of the preliminary prospectus supplement and the accompanying prospectus will also be available free of charge on the website of the SEC at www.sec.gov.

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.

On November 14, 2019 I-Mab Biopharma ("I-Mab"), a China and U.S.-based clinical-stage biopharmaceutical company exclusively focused on the discovery and development of novel or highly differentiated biologics in immuno-oncology and autoimmune diseases reported that National Medical Products Administration (NMPA) approved its IND application for TJM2 to conduct clinical trials in patients with rheumatoid arthritis (RA) (Press release, I-Mab Biopharma, NOV 14, 2019, View Source [SID1234551331]). TJM2 is a humanized immunoglobulin G1 (IgG1) neutralizing antibody targeting the cytokine granulocyte-macrophage colony-stimulating factor (GM-CSF) with the potential to treat patients with autoimmune and inflammatory diseases in which GM-CSF plays a critical role.

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TJM2 is the first in-house developed drug candidate from I-Mab’s global portfolio of internally developed candidates to have entered clinical trials. Earlier this year, I-Mab conducted a first-in-human phase 1 clinical trial with TJM2 in healthy volunteers in the U.S. (NCT03794180). Having successfully completed that trial, I-Mab filed an IND with the NMPA for TJM2 in patients with RA and, subsequently, received regulatory clearance on November 8. The current phase I study is designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and immunogenicity of TJM2 in patients with RA.

"We believe TJM2 has broad potential for the treatment of patients with autoimmune and inflammatory diseases and are pleased to have obtained clearance from the Chinese health authorities to continue further clinical development of TJM2 in RA patients in China," said Jingwu Zang, MD., PhD., Founder and Honorary Chairman of I-Mab Biopharma. "This is an important milestone for I-Mab and demonstrates our ability to conduct clinical trials in both the U.S. and China and leverage data between the countries to expedite our clinical development programs in our goal to bring innovative products to the patients."

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

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.