Cardax Reports Q3 2019 Results

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."

BioCryst Prices Public Offering of Common Stock

On November 14, 2019 BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) reported the pricing of an underwritten public offering of 37,931,035 shares of its common stock, offered at a price to the public of $1.45 per share (Press release, BioCryst Pharmaceuticals, NOV 14, 2019, View Source [SID1234551158]). The gross proceeds from this offering to BioCryst are expected to be $55 million, before deducting underwriting discounts and commissions and estimated offering expenses payable by BioCryst.

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BioCryst has granted the underwriters a 30-day option to purchase up to an additional 5,689,655 shares of its common stock. The offering is expected to close on or about November 18, 2019, subject to customary closing conditions. BioCryst expects to use the net proceeds of this offering for general corporate purposes, which may include, but are not limited to, worldwide development, manufacturing, regulatory and commercial activities for the prophylactic BCX7353 program, primarily focusing on the U.S., EU and Japan; development of the BCX9930 program; development of the BCX9250 program; post-approval commitments for RAPIVAB/ALPIVAB; funding clinical development of pipeline assets; and capital expenditures and other general corporate expenses.

J.P. Morgan is acting as sole book-running manager for the offering. JMP Securities and H.C. Wainwright & Co. are acting as lead managers for the offering.

A shelf registration statement on Form S-3 relating to the shares of common stock described above has been previously filed with and declared effective by the U.S. Securities and Exchange Commission ("SEC"). This press release does not constitute an offer to sell, or the solicitation of an offer to buy, these securities, nor will there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale is not permitted.

This offering is being made by means of a prospectus supplement and related prospectus. A preliminary prospectus supplement relating to the offering has been filed with the SEC and is available on its website at www.sec.gov. Copies of the final prospectus supplement, when available, and accompanying prospectus may be obtained from J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717 or by telephone: 1-866-803-9204.

Alector to Present at the Jefferies 2019 London Healthcare Conference

On November 14, 2019 Alector, Inc. (Nasdaq: ALEC), a clinical stage biotechnology company pioneering immuno-neurology, reported that Sabah Oney, Ph.D., chief business officer of Alector, will present at the Jefferies 2019 London Healthcare Conference on Thursday, Nov. 21, at 8:00 a.m. local time (GMT) in London (Press release, Alector, NOV 14, 2019, View Source [SID1234551281]).

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To access the live webcast of the presentation, please visit the "Events & Presentations" page within the Investors section of the Alector website at View Source A replay will be available on the Alector website for 90 days following the conference.

Achilles Therapeutics to Present at the Jefferies 2019 London Healthcare Conference

On November 14, 2019 Achilles Therapeutics ("Achilles"), a biopharmaceutical company developing personalised cancer immunotherapies, reported that Dr. Iraj Ali, Chief Executive Officer, will present at the Jefferies 2019 London Healthcare Conference on Wednesday, November 20, 2019 at 8.40 am GMT in London, UK (Press release, Achilles Therapeutics, NOV 14, 2019, View Source [SID1234551298]).

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ALX Oncology to Present ALX148 Clinical Data at the 61st American Society of Hematology Annual Meeting (ASH)

On November 14, 2019 ALX Oncology, a clinical-stage immuno-oncology company developing therapies to block the CD47 checkpoint mechanism, reported that ALX148 clinical results have been selected for presentation at the 61st ASH (Free ASH Whitepaper) Annual Meeting & Exposition, December 7 – 10, 2019, Orange County Convention Center, Orlando, FL (Press release, ALX Oncology, NOV 14, 2019, View Source [SID1234551314]).

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"This year’s ASH (Free ASH Whitepaper) meeting will be an opportunity to provide important clinical updates on our CD47 program in hematologic malignancies," said Sophia Randolph M.D., Ph.D., Chief Medical Officer of ALX Oncology. "We are excited to share the first clinical efficacy data from the combination of ALX148 with rituximab, showing that ALX148 maximizes clinical activity with a best-in-class safety profile. We are committed to further development of this agent with the potential to transform standards-of-care for patients with cancer."

Abstract Details
The presentation will include updated clinical data from the ongoing phase 1b study of ALX148, administered up to 15 mg/kg once weekly (molar equivalent to 30 mg/kg once weekly of an antibody), in combination with rituximab in patients with relapsed/refractory non-Hodgkin lymphoma.

Title: A Phase 1 Study of ALX148, a CD47 Blocker, in Combination with Rituximab in Patients with Non-Hodgkin Lymphoma
Session Name: 704. Immunotherapies: Poster I
Session Date: Saturday, December 7, 2019
Presentation Time: 5:30pm – 7:30pm
Location: Orange County Convention Center, Hall B
Publication Number: 1953