Uncategorized – Page 14262 – 1stOncology™: Cancer Intelligence Service

Cardax Reports Q2 2019 Results

On August 14, 2019 Cardax, Inc. (OTCQB:CDXI) reported filed its Quarterly Report on Form 10-Q for the quarter ended June 30, 2019 (Press release, Cardax Pharmaceuticals, AUG 14, 2019, View Source [SID1234538743]).

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Recent developments include:

CHASE Clinical Trial Update

Cardax plans a pre-specified interim review in September 2019 of the aggregate data by treatment group from its CHASE human clinical trial. The CHASE trial is evaluating the effect of ZanthoSyn on cardiovascular inflammatory health, as measured by C-Reactive Protein or "CRP," as a primary endpoint. Other data collected includes secondary inflammatory health markers as well as safety parameters. Positive results could not only support ZanthoSyn marketing but serve as an important proof-of-concept for the Company’s pharmaceutical program and provide additional intellectual property protection.

Interim Financing Update

Cardax also announced today that it raised $1,675,000 in additional capital since the beginning of Q2 2019 ($750,000 in Q2 2019 and $925,000 in Q3 2019 to date), using a combination of convertible notes, equity units (stock and warrants), and loans, the proceeds of which are being used for general corporate purposes.

ZanthoSyn Update

As reported previously, in Q1 2019 retail "sell-through," defined as retail sales of ZanthoSyn to customers at General Nutrition Corporation ("GNC") stores, surpassed all previous periods and Q2 2019 continued at strong levels as the third best performing quarter since launch. In addition, 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. Notwithstanding, GNC continued to trim the inventory sell-in substantially in Q2 2019. "Sell-in" is defined as wholesale orders of ZanthoSyn by GNC less sales incentives, promotions, discounts, and refunds. As a result, Cardax net revenues were $45,391 and $210,363 for the 3 and 6 months ended June 30, 2019 compared to $272,049 and $585,359 for the 3 and 6 months ended June 30, 2018.

While ZanthoSyn sell-in to GNC in Q3 2019 to date has already exceeded the total Q2 2019 sell-in, Cardax provided notice to GNC that its "U.S. brick-and-mortar retail store" exclusivity contract with GNC for ZanthoSyn would not automatically renew in October 2019. Cardax may expand ZanthoSyn distribution to mass market retailers, other specialty nutrition stores, pharmacies, and other retailers.

Cardax plans to expand its direct-to-consumer e-commerce efforts by capitalizing on one of the most important lessons learned from its sales and marketing program: "Conversations Create Customers." Whether at GNC stores, directly with Cardax personnel, or at conferences for healthcare professionals, thousands of ZanthoSyn customers have been created by understanding and experiencing the benefits of ZanthoSyn firsthand. Cardax plans to implement strategies that it believes may create a similar customer experience more broadly, with fulfillment online, where margins are greater than retail stores.

"As inflammatory health becomes ever more important to the scientific, medical, and financial communities, we look forward to the interim review of our CHASE clinical trial," said David G. Watumull, Cardax President and CEO. "We are also pleased to see ZanthoSyn’s strong retail sales at GNC drive an increase in wholesale orders in Q3 and look forward to expanding our ZanthoSyn marketing and distribution more broadly."

Aethlon Medical Announces First Quarter Financial Results and Provides Corporate Update

On August 14, 2019 Aethlon Medical, Inc. (Nasdaq: AEMD), a therapeutic technology company focused on unmet needs in global health, reported financial results for its first quarter ended June 30, 2019 and provided an update on recent developments (Press release, Aethlon Medical, AUG 14, 2019, View Source [SID1234538744]).

Company Updates

Aethlon Medical, Inc. (Company or Aethlon) is continuing the development of its proprietary Hemopurifier, which is a first in class therapeutic device designed for the single use depletion of circulating viruses and cancer-promoting exosomes. The Hemopurifier has previously been designated a Breakthrough Device by the FDA for the treatment of glycosylated viruses, including Ebola and other hemorrhagic fever viruses, and in late 2018 was additionally designated as a Breakthrough Device "…for the treatment of individuals with advanced or metastatic cancer who are either unresponsive to or intolerant of standard of care therapy, and with cancer types in which exosomes have been shown to participate in the development or severity of the disease….".

Aethlon is currently preparing for the initiation of clinical trials in patients with advanced and metastatic cancers. The Company is initially focused on the treatment of solid tumors, including head and neck cancer, gastrointestinal cancers and other cancers. Following discussions and a meeting with the FDA, the Company is preparing to file an Investigational Device Exemption (IDE) application with the FDA to initiate clinical trials in cancer.

On June 30, 2019, the Company entered into a cross-licensing agreement with SeaStar Medical, Inc. to jointly develop Aethlon’s and SeaStar’s combined medical devices to address the care and management of critically ill patients. Under this agreement, Aethlon and SeaStar are now initiating development of systems for the transplant, oncology and infectious disease settings.

Financial Results for First Quarter Ended June 30, 2019

The Company’s net loss was approximately $2.1 million, or $(0.11) per share, for the first quarter ended June 30, 2019, compared to a net loss of approximately $1.1 million, or $(0.06) per share, for the quarter ended June 30, 2019.

At June 30, 2019, the Company had a cash balance of approximately $2.5 million.

The Company’s consolidated operating expenses for the quarter ended June 30, 2019 were approximately $1.6 million, compared to $1.25 million for the June 2018 quarter. This increase of approximately $350,000, in 2019 was due to increases in general and administrative expenses of approximately $188,000, professional fees of approximately $158,000 and payroll and related expenses of approximately $3,000.

The $188,000 increase in general and administrative expenses in 2019 was primarily due to the combination of a $120,000 increase in our clinical trial expense, primarily costs associated with the manufacturing of Hemopurifiers for an expected clinical trial in the cancer space, a $39,000 increase in our lab supplies expense, primarily related to our breast cancer grant, and a $39,000 increase in travel expense.

The $158,000 increase in our professional fees in 2019 was primarily due to a $152,534 increase in our legal fees.

The $3,000 increase in payroll and related expenses was primarily due to a $63,374 increase in stock-based compensation, which was partially offset by a $59,944 reduction in our cash-based compensation expense.

The Company’s other expense during the quarter ended June 30, 2019 consisted of interest expense and a loss on debt extinguishment and, during the three months ended June 30, 2018, consisted of interest expense only. Other expense for the three months ended June 30, 2019 was approximately $501,000, in comparison with other expense of approximately $55,000 for the quarter ended June 30, 2018.

The Company recorded government contract and grant revenue in the first quarters ended June 30, 2019 and 2018. This revenue arose from work performed under two government contracts with the National Institutes of Health (NIH). In the quarter ended June 30, 2019, the Company recorded $30,000 in aggregate revenue from its Breast Cancer grant and in the quarter ended June 30, 2018, the Company recorded approximately $150,000 in revenue from its Melanoma Cancer contract with the NIH.

The unaudited condensed consolidated balance sheet for June 30, 2019 and the unaudited condensed consolidated statements of operations for the first quarter ended June 30, 2019 and 2018 follow at the end of this release.

Conference Call

The Company will hold a conference call today, Wednesday, August 14, 2019 at 4:30 p.m. Eastern Time to review financial results and recent corporate developments. Following management’s formal remarks, there will be a question and answer session.

To listen to the call by phone, interested parties within the U.S. should call 1-844-836-8741 and International callers should call 1-412-317-5442. All callers should ask for the Aethlon Medical, Inc. conference call.

A replay of the call will be available approximately one hour after the end of the call through August 21, 2019. The replay can be accessed via Aethlon’s website or by dialing 1-877-344-7529 (domestic) or 1-412-317-0088 (international) or Canada Toll Free at 1-855-669-9658. The replay conference ID number is 10134273.

Oncolytics Biotech® Announces Pricing of Its USD $3.7M – CDN $4.9M Public Offering of Common Share and Warrants

On August 14, 2019 Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC) (the "Company"), currently developing pelareorep, an intravenously delivered immuno-oncolytic virus, provides an update to confirm that its previously reported underwritten public offering of USD $3.7M (CDN $4.9M) was priced at USD $0.81 (CDN $1.07) (Press release, Oncolytics Biotech, AUG 14, 2019, View Source [SID1234538764]).

All other details of the previous release are correct and copied below:

Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC) (the "Company"), currently developing pelareorep, an intravenously delivered immuno-oncolytic virus, reported the pricing of its previously announced underwritten public offering (the "Offering") of 4,619,773 common shares and warrants to purchase up to 4,619,773 common shares at a combined public offering price of $0.81 per share and warrant, resulting in gross proceeds of approximately USD 3.7M. Each warrant has an exercise price of $0.90 per common share, is exercisable immediately and will expire 5 years from the date of issuance. The common shares and the accompanying warrants can only be purchased together in this Offering but will be issued separately.

The Offering is expected to close on or about August 16, 2019, subject to the satisfaction of customary closing conditions. Oncolytics has also granted to the underwriter a 30-day option to purchase up to an additional 692,965 common shares and/or warrants to purchase up to 692,965 common shares, at the public offering price per common share and warrant, less underwriter discounts and commissions. The Offering is subject to customary closing conditions, including Nasdaq and TSX approvals.

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

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 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 prospectus supplements relating to the Offering (together with the Base Shelf Prospectus and the Registration Statement, the "Offering Documents") have been 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 final 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.

Precision BioSciences Reports Second Quarter 2019 Financial Results and Highlights Ongoing Operational Progress

On August 14, 2019 Precision BioSciences, Inc. (Nasdaq: DTIL) ("Precision"), a genome editing company dedicated to improving life through the application of its pioneering, proprietary ARCUS platform, reported financial results for the second quarter ended June 30, 2019, and provided a corporate update (Press release, Precision Biosciences, AUG 14, 2019, View Source [SID1234538814]).

Key Highlights and Recent Developments

Initiated a Phase 1/2a clinical trial of Precision’s first off-the-shelf (allogeneic) chimeric antigen receptor (CAR) T cell therapy candidate, PBCAR0191. PBCAR0191 will be evaluated in adult patients with relapsed or refractory ("R/R") non-Hodgkin lymphoma ("NHL") or R/R B-cell precursor acute lymphoblastic leukemia ("B-ALL").

Enrolled and dosed patients in the Phase 1/2a clinical trial of PBCAR0191 consistent with expected timelines at three leading US sites with expertise in CAR T cell therapies: Moffitt Cancer Center, Dana Farber Cancer Institute, and City of Hope National Medical Center.

Enhanced senior leadership team with key appointments including Chief Medical Officer Christopher R. Heery, MD, and General Counsel, Dario Scimeca.

Presented pre-clinical updates for multiple in vivo gene editing programs at the American Society for Gene and Cell Therapy (ASGCT) (Free ASGCT Whitepaper) Annual Meeting.

Opened an in-house Current Good Manufacturing Practice (cGMP) compliant manufacturing facility, believed to be the first in the United States dedicated to genome-edited, off-the-shelf CAR T cell therapy product candidates.

Celebrated Mario Pennisi, Resident Director of wholly-owned subsidiary Elo Life Systems Inc. (Elo Life Systems), being awarded the BIO Leadership and Legacy Award in Industrial Biotech and Agriculture.

Ended the quarter with $226 million in cash and cash equivalents, expected to fund operating expenses and capital expenditure requirements into 2021.

"Following the closing of our successful IPO at the beginning of April, we have continued to leverage the unique capabilities of our proprietary ARCUS genome editing platform for therapeutic and human health applications. We achieved a significant milestone in our mission to deliver transformative, off-the-shelf CAR T cell therapies to cancer patients by dosing the first subjects with our lead allogeneic product candidate, PBCAR0191. Our portfolio of in vivo gene correction candidates continues to progress towards the clinic, and we are excited by the ongoing momentum at Elo Life Systems," commented Matt Kane, Chief Executive Officer and Co-Founder of Precision. "In the second quarter of 2019, we also successfully expanded our senior leadership team and are pleased to welcome Christopher Heery, MD, as Precision’s first Chief Medical Officer, and Dario Scimeca as General Counsel. In addition, we expect that our newly opened, in-house CAR T cell manufacturing facility, which we believe to be the first of its kind in the United States, will be able to support multiple simultaneous clinical trials and, in time, the commercialization of our product candidates, if approved. Our focus on manufacturing continues to demonstrate our commitment to rapidly deliver our advanced therapeutic candidates to patients in need."

Other Highlights and Upcoming Milestones

Program updates

On April 15, 2019, Precision initiated dosing of its first allogeneic CAR T cell therapy candidate, PBCAR0191, in a Phase 1/2a clinical trial. PBCAR0191 is being developed in collaboration with Servier, an international pharmaceutical company. Made from donor-derived T cells modified using Precision’s ARCUS genome editing technology, PBCAR0191 recognizes the tumor cell surface protein CD19, an important and validated target in several B-cell cancers, and is designed to avoid graft-versus-host disease, a significant complication associated with donor-derived, cell-based therapies. Precision believes this to be the first US-based clinical trial to evaluate an allogeneic CAR T therapy for R/R NHL. The trial is designed to assess safety and tolerability of PBCAR0191 at increasing dose levels, with secondary objectives including evaluation of anti-tumor activity. Dosing of subjects continues to progress as planned. Precision expects to present interim data from this trial at a scientific conference no later than the first quarter of 2020.

Precision’s second allogeneic CAR T cell therapy product candidate, PBCAR20A, is expected to enter a Phase 1/2a clinical trial in the fourth quarter of 2019. PBCAR20A is wholly owned by Precision and targets the validated tumor cell surface target CD20. It will be investigated in subjects with two subtypes of NHL, chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL).

At the ASGCT (Free ASGCT Whitepaper) Annual Meeting held in Washington, DC from April 29 to May 2, 2019, Precision presented several updates on its in vivo gene editing programs. During the meeting, Precision’s scientists and collaborators shared updates on four pre-clinical programs: hepatitis B (HBV, being developed in partnership with Gilead), autosomal dominant retinitis pigmentosa (adRP), primary hyperoxaluria (PH1), and familial amyloid polyneuropathy (FAP). Discussions with the US Food and Drug Administration (FDA) for the HBV program are planned for the second half of 2019.

Senior management additions

On May 14, 2019, Precision announced the first of two significant hires in the second quarter with Christopher R. Heery, MD, joining as the Company’s first Chief Medical Officer (CMO). Dr. Heery has strong experience managing translational clinical programs, having served as head of the Clinical Trials Group of the Laboratory of Tumor Immunology and Biology at the National Cancer Institute where he was the lead associate investigator of the Phase 1 study of the anti-PD1 immunotherapy avelumab. He also served as CMO at Bavarian Nordic and is board certified in both medical oncology and internal medicine.

On June 12, 2019, Precision announced the appointment of Dario Scimeca as General Counsel. Mr. Scimeca joined Precision from Genentech where he supported the development and commercialization of multiple drug products including Rituxan, Tecentriq, Gazyva, Venclexta and Hemlibra as associate general counsel. A graduate of UC Berkeley Law School, in his previous roles Mr. Scimeca has overseen US FDA and European Medicines Agency regulatory matters, managed securities and intellectual property litigation, and been responsible for commercial contracts and compliance matters.

Manufacturing Center for Advanced Therapeutics

On July 18, 2019, Precision announced the opening of its in-house cGMP compliant manufacturing facility, located in Research Triangle Park, North Carolina, which the Company believes to be the first in the United States dedicated to genome-edited, off- the-shelf CAR T cell therapy product candidates. The Manufacturing Center for Advanced Therapeutics (MCAT) is designed to enable in-house production of three different drug substances: allogeneic CAR T cells, messenger RNA (including formulations development) and adeno-associated viral vectors. Precision intends to use this new manufacturing center to create clinical trial material for its planned Phase 1/2 clinical trials starting in 2020. In the longer term, Precision believes MCAT has the potential to be a commercial launch facility with the capacity to generate up to 10,000 allogeneic doses of CAR T cell therapies and 4,000 doses of gene therapies per year.

Elo Life Systems

Also in July 2019, the Company’s wholly owned subsidiary, Elo Life Systems, which is dedicated to creating novel products that enhance the nutrition and diversity of the global food supply, announced that Mario Pennisi, Resident Director of Elo Life Systems – Australia was awarded the prestigious BIO Leadership and Legacy Award in Industrial Biotech and Agriculture. The award is presented to individuals who have shown exemplary leadership and dedicated a significant portion of their career to advancing industrial biotechnology and growing the bio-based economy. This award further demonstrates the depth of talent at Precision, and the pioneering work ongoing at Elo Life Systems.

Upcoming Corporate Presentations

Precision’s senior management team will be presenting and meeting with investors at the following upcoming conferences:

Baird Global Healthcare Conference, New York, NY, Sept. 4 – 5, 2019

Presentation and panel discussion at The Alliance for Regenerative Medicine’s Cell and Gene Meeting on the Mesa, Carlsbad, CA, Oct. 2 – 4, 2019

Chardan Genetic Medicines Conference, New York, NY, Oct. 7 – 8, 2019

Jefferies Gene Therapy Summit Presentation, New York, NY, Oct. 9, 2019

Stifel 2019 Healthcare Conference, New York, NY, Nov. 19 – 20, 2019

Jefferies London Healthcare Conference, London, UK, Nov. 20 – 21, 2019

Piper Jaffray Annual Health Care Conference, New York, NY, Dec. 3 – 5, 2019

Second Quarter 2019 Financial Results

Cash and Cash Equivalents: As of June 30, 2019, Precision had approximately $226.1 million in cash and cash equivalents. We expect that existing cash and cash equivalents will be sufficient to fund operating expenses and capital expenditure requirements into 2021.

Revenues: Total revenues for the quarter ended June 30, 2019 were $5.4 million, compared to $1.9 million for the quarter ended June 30, 2018. This increase was primarily due to research funding from our joint development collaboration partners.

Research and Development Expenses: Research and development expenses were $22.8 million for the quarter ended June 30, 2019, as compared to $10.9 million for the same period in 2018. This increase of $11.9 million was primarily due to increases in platform development and early-stage research expenses due to contract manufacturing costs and an increase in personnel costs and expenses to support our technology platform development and manufacturing capabilities, partially offset by a decrease in direct research and development expenses related to our CD19 program.

General and Administrative Expenses: General and administrative expenses were $6.5 million for the quarter ended June 30, 2019, as compared to $3.1 million for the same period in 2018. The increase of $3.4 million was primarily due to employee-related costs for our additional personnel and facility costs associated with our growing infrastructure needs.

Net Loss: Net loss was $19.4 million, or $(0.39) per share, for the quarter ended June 30, 2019, compared to a net loss of $11.8 million, or $(0.75) per share, for the same period in 2018.

Oncolytics Biotech(R) Announces Pricing of Its Public Offering of Common Share and Warrants

On August 14, 2019 Oncolytics Biotech Inc. (NASDAQ:ONCY) (TSX:ONC) (the "Company"), currently developing pelareorep, an intravenously delivered immuno-oncolytic virus, reported the pricing of its previously announced underwritten public offering (the "Offering") of 4,619,773 common shares and warrants to purchase up to 4,619,773 common shares at a combined public offering price of $0.81 per share and warrant, resulting in gross proceeds of approximately USD 3.7M (Press release, Oncolytics Biotech, AUG 14, 2019, View Source [SID1234538727]). Each warrant has an exercise price of $0.90 per common share, is exercisable immediately and will expire 5 years from the date of issuance. The common shares and the accompanying warrants can only be purchased together in this Offering but will be issued separately.