On August 12, 2019 VolitionRx Limited (NYSE AMERICAN: VNRX) ("Volition") reported financial results and a business update for the second quarter ended June 30, 2019 (Press release, VolitionRX, AUG 12, 2019, View Source [SID1234538611]). Volition management will host a conference call tomorrow, August 13, at 8:30 a.m. U.S. Eastern Time to discuss these results. Conference call details may be found below.

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Click here to view an interview with Volition’s Chief Executive Officer.

An interview with Cameron Reynolds, Chief Executive Officer
An interview with Cameron Reynolds, Chief Executive Officer
Cameron Reynolds, President and Chief Executive Officer of Volition, upon releasing these results, commented, "I could not be more proud of our dedicated team at Volition, and the ground-breaking work they are doing. I’m happy to say that we have made significant progress on colorectal cancer and lung cancer trials, particularly in Asia, as well as on our platform development, Nu.Q Capture discovery research and, of course, the development of Nu.Q Vet.

We are an epigenetics company focused on advancing the science of epigenetics and exploiting these advances in human and animal health. This has been our mission since our founding, and it is coming to fruition with our Nu.Q platform at the very heart of epigenetics. We believe the last decade of work and our extensive intellectual property portfolio puts Volition in a strong position to be a significant player in this field."

Mr. Reynolds further commented "We aim to strengthen our product pipeline beyond colorectal cancer to cover several cancers, most notably in lung cancer, and so are especially delighted to have executed agreements with the National Taiwan University to conduct our first large-scale study in lung cancer and with Shanghai Fosun Long March Medical Science Co. Ltd. to conduct our first lung cancer study in China. I am also delighted to announce the recent formation of a Texas-based subsidiary, Volition Veterinary Diagnostics Development LLC, to focus on the development and commercialization of our Nu.Q Vet products and help drive early revenue."

Additionally, Mr. Reynolds added "During the second quarter 2019, we further strengthened our balance sheet with an existing investor exercising $5 million in aggregate amount of outstanding warrants to purchase shares of our common stock and ended the quarter with cash and cash equivalents of $18.5 million. Subsequent to quarter-end, a further $4.8 million in warrants were exercised for cash, making a total of $16.5 million in warrants exercised this year. We have also been awarded a further $1.4 million in non-dilutive grant-funding from the Walloon Region."

Company Highlights

Financial

Cash and cash equivalents as of June 30, 2019 totaled $18.5 million compared to $13.4 million as of the end of 2018.
An additional $4.8 million in aggregate exercise price of warrants (at $3 per share of common stock) were exercised subsequent to the quarter-end.
Continued to manage cash carefully with a cash burn of $2.9 million in the second quarter of 2019.
Clinical Trials

Added to our extensive clinical trial program with the execution of a contract to conduct our first large-scale lung cancer study in conjunction with the prestigious National Taiwan University ("NTU"). The study is being conducted under the supervision of Professor Chen Jin-Shing in the Department of Surgery of NTU and will include 1,200 subjects receiving Low-Dose Computed Tomography scans, including 1,000 with lung cancer. We expect the first data from this trial in the first quarter of 2020.
Executed a contract with Shanghai Fosun Long March Medical Science Co., Ltd. to conduct our first study, a lung cancer study, in China. This study is underway, and we expect it will be completed in 2019.
Organizational

Formed a U.S.-based subsidiary, Volition Veterinary Diagnostics Development LLC, to drive the development and commercialization of Nu.Q Vet products and appointed its Chief Executive Officer, Mr. Nathan Dewsbury.
Executed a non-binding Memorandum of Understanding with Texas A&M University’s College of Veterinary Medicine to conduct a study of Nu.Q Vet.
Intellectual Property

Achieved steady growth in worldwide patent portfolio. This is a key differentiator versus many other technologies either under development or available on the market, where the patent position may be poor and/or narrow.
– 20 patent families related to our diagnostic tests (including both human and veterinary medicine applications).

– 7 patents granted in the United States.

– 7 patents granted in the European Union.

– 25 further patents granted worldwide.

– 106 patents pending worldwide.

Upcoming Milestones

We expect to achieve the following milestones during 2019 and beyond:

Advance our previously announced large-scale colorectal cancer trials in Europe, the U.S. and Asia.
Advance the clinical trial program for lung cancer, focusing initially on the significant need in Asia, most notably in China.
Through our subsidiary, Volition Veterinary, determine and announce the route to revenue for Nu.Q Vet with the aim of having a USDA-approved product in 2020.
Announce the results of multiple proof of concept cancer studies to include prostate, pancreatic and ovarian, in addition to our 27-cancer study, and initiate larger studies.
Announce preliminary results of Nu.Q’s performance in other disease conditions, including endometriosis.
Advance the development of Nu.Q Capture by determining the level of discrimination of tumor associated nucleosomes using mass spectrometry and sequencing.
Mr. Reynolds concluded, "We are extremely proud of the accomplishments we have achieved thus far. I thank the dedicated Volition team for their tireless efforts. I, along with the rest of the Board and indeed the whole company, look forward to sharing the results of key studies over the coming year."

For further details please contact [email protected].

VolitionRx Limited Second Quarter 2019 Earnings
and Business Update Conference Call

Date: Tuesday, August 13, 2019
Time: 8:30 a.m. U.S. Eastern time
U.S. & Canada Dial-in: 1-877 407 9716 (toll free)
U.K. Dial-in: 0 800 756 3429 (toll free)
Toll/International: 1-201 493 6779
Conference ID: 13693585
Cameron Reynolds, President and Chief Executive Officer of Volition, will host the call along with David Vanston, Chief Financial Officer and Scott Powell, Executive Vice President, Investor Relations. The call will provide an update on recent developments and Volition’s activities, including details of new and ongoing clinical trials, important events which have taken place in the second quarter of 2019, and milestones for 2019 and beyond.

On August 12, 2019 Aridis Pharmaceuticals, Inc. (Nasdaq: ARDS), a biopharmaceutical company focused on the discovery and development of targeted immunotherapies using fully human monoclonal antibodies (mAbs) to treat life-threatening bacterial infections, reported financial and corporate results for the second quarter ended June 30, 2019 (Press release, Aridis Pharmaceuticals, AUG 12, 2019, View Source [SID1234538610]).

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Second Quarter Highlights and Recent Developments

Remained on schedule to report top line data in Q3 2019 for AR-105’s global Phase 2 clinical trial for the treatment of ventilator-associated pneumonia (VAP) caused by Pseudomonas aeruginosa (P. aeruginosa).
Received Orphan Drug designation from the U.S. Food and Drug Administration (FDA) and The European Medicines Agency (EMA) for AR-501, an inhalable therapy being clinically tested for the treatment of chronic lung infections in cystic fibrosis patients.
Received Qualified Infectious Diseases Product (QIDP) and Fast-Track designations from the FDA for AR-501.
Maintained enrollment pace of AR-501’s Phase 1/2a clinical trial with top-line data from healthy subjects expected towards the end of Q1 2020 and from cystic fibrosis patients in Q2 2021.
Advanced Phase 3 global clinical trial of AR-301 targeting gram-positive Staphylococcus aureus (S. aureus) in critically ill VAP patients. Remained on track to report interim data in Q1 2020 with top line data expected in late 2020.
Bolstered leadership team with appointment of Dr. Susan Windham-Bannister to Board of Directors.
Announced the execution of a $10 million equity purchase transaction at a premium of approximately 31% and entered into an option agreement with Serum International B.V. ("SIBV"), an affiliate of the Serum Institute of India Private Limited ("SIIL"), for exclusive rights to license products and mAb discovery platform technology MabIgX.
Received an upfront cash payment of $5 million upon execution of the option agreement with SIBV and will receive an additional $10 million upon execution of the license agreement by August 31, 2019.
"The second quarter proved to be a significant period of growth for the company," commented Vu Truong, Ph.D., Chief Executive Officer of Aridis Pharmaceuticals. "In addition to maintaining the development pace of our clinical programs, I am very pleased with the work performed by the entire team as we evaluated and ultimately brought on SIBV as a shareholder and potentially a commercial partner for certain ex-U.S. and ex-EU markets. SBIV’s parent company, SIIL, is a bona fide leader in vaccines and biologics that has in recent years acquired formidable capabilities in monoclonal antibody development and manufacturing. I am particularly pleased that the option agreement not only includes a selection of our products, but also provides SIBV access to our ground-breaking MabIgX platform for new asset identification and development, which is a testament to the quality of the technology."

Clinical Program Update

AR-105: The Company is pleased to report that AR-105’s global Phase 2 clinical trial is on track to report topline data in Q3 2019. The trial, which was fully enrolled during the first quarter of 2019, consists of 158 treated patients and is evaluating AR-105, a broadly active, fully human IgG1 monoclonal antibody for the treatment of VAP caused by gram-negative P. aeruginosa. Details of the study can be viewed on www.clinicaltrials.gov using identifier NCT03027609.

AR-105 has the potential to treat all patient populations infected by P. aeruginosa and is not limited to any subset of P. aeruginosa infected patients. Therefore, pending the outcome of the Phase 2 trial, Aridis will evaluate whether there is a need to embark on a separate Phase 2/3 clinical trial for AR-101, another pipeline product which is a highly specific monoclonal antibody targeting P. aeruginosa lipopolysaccharide serotype O11 that accounts for a subset of approximately 22% of all P. aeruginosa hospital-acquired infections worldwide.

AR-301: During the second quarter, Aridis continued enrolling its Phase 3 global clinical trial for AR-301, which targets gram-positive S. aureus in critically ill VAP patients. The trial, which was initiated in the first quarter of 2019, is expected to enroll 240 patients at approximately 140 clinical centers in 20 countries. Interim data is expected in Q1 2020 and top line data is expected in late 2020. Participating centers in all countries are following the same stringent clinical protocols and procedures for critically ill VAP patients, as is standard in the U.S. and Europe. The trial represents the first ever Phase 3 superiority clinical study evaluating immunotherapy with a fully human monoclonal antibody to treat acute pneumonia in the intensive care unit (ICU) setting. Details of the study can be viewed on www.clinicaltrials.gov using identifier NCT03816956.

AR-301 is a broadly active, fully human monoclonal IgG1 antibody, specifically targeting gram-positive S. aureus alpha-toxin. It has been shown in vitro to protect against alpha-toxin mediated destruction of host cells, thereby potentially preserving the human immune response. AR-301’s mode of action is independent of the antibiotic resistance profile of S. aureus and it is active against infections caused by both MRSA (methicillin resistant S. aureus) and MSSA (methicillin sensitive S. aureus).

AR-501: During the second quarter, Aridis continued enrolling patients in its Phase 1/2a clinical trial of this inhalable formulation of gallium citrate being evaluated to treat chronic lung infections associated with cystic fibrosis. The single ascending dose cohorts of healthy subjects have completed dosing and the Safety Monitoring Committee has recommended proceeding into the multiple ascending dose cohorts. The Company expects to report data from the Phase 1 portion of the trial which consists of healthy subjects in Q1 2020 and the Phase 2a segment with cystic fibrosis subjects in Q2 2021.

AR-501, which is being developed in collaboration with the Cystic Fibrosis Foundation, has been granted by the FDA both Fast Track and QIDP designations. In addition, during the second quarter, the FDA and recently (July 19, 2019), the EMA granted AR-501 Orphan Drug Designation.

Details of the Phase 1/2a clinical trial, which is a randomized, double-blinded, placebo controlled single and multiple dose-ascending trial investigating the safety and pharmacokinetics of inhaled AR-501 in healthy volunteers and cystic fibrosis patients with chronic bacterial lung infections, can be viewed on www.clinicaltrials.gov using identifier NCT03669614. The study is expected to accrue 48 healthy adult volunteers and 48 cystic fibrosis patients from approximately 15 sites in the U.S.

Corporate Update and Recent Developments

During the second quarter, the Company enhanced its leadership team with the appointment of Susan Windham-Bannister, Ph.D., to its Board of Directors. Dr. Windham-Bannister, an internationally recognized expert in advising biopharma companies on market access, growth optimization and portfolio management strategies, currently serves as President and CEO of Biomedical Growth Strategies., LLC and Managing Partner of Biomedical Innovation Advisors, LLC, an advisory firm serving the healthcare industry which she founded with Dr. Harvey Lodish, co-founder of Genzyme. As Aridis prepares for multiple data readouts over the course of 2019 and into the first quarter of next year, Dr. Windham-Bannister’s expertise will be utilized in addressing key areas such as healthcare policy, drug reimbursement and commercial strategy for the Company’s product candidates.

On July 30, 2019, Aridis announced that the Company entered into equity purchase and option agreements with SIBV, the world’s largest vaccine manufacturer by dose. SIBV invested $10 million into Aridis and received 801,820 shares of the Company’s restricted common stock at a price of approximately $12.47 per share, which represented a premium of approximately 31% to the closing share price of Aridis common stock on July 29, 2019.

Pursuant to the option agreement, Aridis received a $5 million upfront payment and will receive an additional $10 million upon execution of the license agreement by August 31, 2019. The upfront payment is refundable should the parties not complete the license agreement. Furthermore, assuming the license agreement is executed, Aridis expects to receive as much as $42.5 million in future milestone payments for achieving product development and commercial objectives, along with royalties on net sales.

The license agreement will provide SIBV with the right to in-license Aridis’ clinical stage programs AR-301(VAP), AR-105 (VAP) and AR-101 (hospital acquired pneumonia (HAP)). These license rights will be exclusive and to a limited territory which includes markets outside of the U.S., Europe, Canada, UK, China, Australia, New Zealand and Japan. Also, the agreement will include the option to acquire an exclusive, worldwide license (excluding China) to AR-201, a preclinical fully human mAb for the prevention of respiratory syncytial virus (RSV). In addition, SIBV may elect to collaborate with Aridis to utilize MabIgX to identify and advance up to five SIBV wholly-owned programs. MabIgX is Aridis’ proprietary technology platform to rapidly identify rare, potent antibody-producing B-cells from patients who have successfully overcome an infection to produce mAbs.

Fiscal 2019 Second Quarter Results:

Cash: Total cash and cash equivalents as of June 30, 2019 was $8.5 million. In July 2019, we received net proceeds of approximately $9.2 million from the sale of 801,820 shares of restricted common stock. In addition, the Company received an upfront cash payment of $5 million upon the execution of an option agreement. This upfront payment is refundable should the parties not complete the license agreement by August 31, 2019.
Revenues: Total revenues for the quarter ended June 30, 2019 was zero, a decrease of $22,000 over the same period in 2018.
Research and Development Expenses: Research and development expenses for the quarter ended June 30, 2019 were $6.7 million, an increase of $2.8 million over the same period in 2018 due primarily to an increase in spending on clinical trial activities and drug manufacturing for our AR-301 program and an increase in spending on drug manufacturing for our AR-105 Phase 3 program, partially offset by a decrease in spending on clinical trial activities for our AR-105 Phase 2 program, and a decrease in spending on toxicology studies related to our AR-501 program.
General and Administrative Expenses: General and administrative expenses for the quarter ended June 30, 2019 were $1.6 million, an increase of $0.9 million over the same period in 2018 due primarily to an increase in professional service fees, an increase in personnel related expenses, an increase in directors’ and officers’ liabilities insurance expense, and an increase in Delaware franchise taxes and patent related fees.
Interest and Other Income, net: Interest and other income, net for the quarter ended June 30, 2019 was $69,000, an increase of approximately $1,000 over the same period in 2018. These increases were due primarily to a higher rate of return on our cash balance partially offset by a lower average cash balance.
Change in Fair Value of Warrant Liability: As a result of all warrants to purchase preferred stock being converted into warrants to purchase common stock upon our IPO in August 2018, there was no warrant liability recorded at the end of the second quarter of 2019. There was a $3.1 million gain attributed to a decrease in the fair value of the warrant liability in the second quarter of 2018.
Net Loss: The net loss available to common shareholders for the quarter ended June 30, 2019 was $8.4 million, or ($1.03) per share, compared to a net loss available to common shareholders of $2.0 million, or ($11.78) per share, for the quarter ended June 30, 2018. It should be noted that there were 166,373 common shares outstanding during the second quarter of 2018 and until the completion of the Company’s IPO in August 2018. Moreover, there were convertible preferred shares outstanding until the time of the IPO which earned dividends that were distributed as additional shares of preferred stock. All preferred shares were converted to common stock upon the completion of the IPO on August 16, 2018. There were 8.1 million common shares outstanding after the completion of the IPO when all preferred shares were converted to common shares. At December 31, 2018 and at June 30, 2019, there were 8.1 million shares common shares outstanding.

On August 12, 2019 Precision Optics Corporation, Inc. (OTCQB: PEYE) (the "Company") reported that it has scheduled a conference call to discuss preliminary fourth quarter and fiscal 2019 revenue as well as its recent acquisition of Ross Optical Industries on Thursday, August 15, 2019 at 5:00pm ET (Press release, Precision Optics, AUG 12, 2019, View Source [SID1234538609]).

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The Company intends to release its preliminary revenue and to file an 8-K/A including pro forma financials associated with its acquisition of Ross Optical Industries, which was originally announced on July 8, 2019, after the close of the market on August 15, 2019 followed by the conference call.

Conference Call Details

Date and Time: Thursday, August 15, 2019 at 5:00pm ET

Call-in Information: Interested parties can access the conference call by dialing (877) 317-6789 or (412) 317-6789.

Live Webcast Information: Interested parties can access the conference call via a live Internet webcast, which is available at View Source

Replay: A teleconference replay of the call will be available until August 22, 2019 at (877) 344-7529 or (412) 317-0088, confirmation #10134182. A webcast replay will be available at View Source

On August 12, 2019 Portola Pharmaceuticals, Inc. (Nasdaq: PTLA) reported plans to offer, subject to market and other conditions, $200 million of its common stock in an underwritten public offering (Press release, Portola Pharmaceuticals, AUG 12, 2019, View Source [SID1234538608]). The company expects to grant the underwriters a 30-day option to purchase up to an additional $30 million of its common stock in connection with the offering. All of the shares of common stock in the offering will be sold by Portola Pharmaceuticals.

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Goldman Sachs & Co. LLC, Citigroup, Cowen, and William Blair are acting as joint book-running managers. Oppenheimer & Co. Inc. is acting as lead manager for the offering. A registration statement related to the offering has been filed with the Securities and Exchange Commission and became effective on August 7, 2019. A preliminary prospectus supplement and final prospectus supplement, when available, may be obtained from Goldman Sachs & Co. LLC, Prospectus Department, 200 West Street, New York, NY 10282, by telephone at 866-471-2526, by facsimile at 212-902-9316 or by email at [email protected]; Citigroup Global Markets Inc., c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by telephone at 1-800-831-9146; Cowen and Company, LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, Attn: Prospectus Department, by telephone at 631-592-5973 or by email at [email protected]; or William Blair & Company, L.L.C., Attention: Prospectus Department, 150 North Riverside Plaza, Chicago, IL 60606, by telephone at 800-621-0687 or by email at [email protected].

This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction. Any offer, if at all, will be made only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement.

On August 12, 2019 Phio Pharmaceuticals Corp. (NASDAQ: PHIO), a biotechnology company developing the next generation of immuno-oncology therapeutics based on its proprietary self-delivering RNAi (sd-rxRNA) therapeutic platform, reported its financial results for the second quarter ended June 30, 2019, and provided a business update (Press release, Phio Pharmaceuticals, AUG 12, 2019, View Source [SID1234538607]).

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"Our focus in 2019 remains on execution of our new development strategy, as we continue to advance and expand our immuno-oncology pipeline," said Dr. Gerrit Dispersyn, Phio’s President and CEO. "During the first half of the year, we’ve continued to accelerate our R&D efforts and have made significant progress with our lead candidates. We are now are on track to initiate up to three clinical programs in 2020. Our novel sd-rxRNA for silencing PD-1 receptor expression by T cells is approaching the clinic for both ex vivo application to enhance adoptive cell transfer efficiency and for direct local administration into the tumor micro-environment. In parallel, we are advancing our sd-rxRNA compound designed to overcome immune exhaustion and activate T cells and natural killer cells. As we complete clinical translation for these lead assets, we also expect to announce additional pipeline updates in the near future."

Mid-Year Review

Organization: In March 2019, Dr. Dispersyn was appointed as the Company’s President and CEO, and in April 2019, Dr. John A. Barrett joined the Company as Chief Development Officer. With more than 25 years of experience in research and development, most recently at Ziopharm Oncology, Inc., Dr. Barrett has made an immediate and significant positive impact. Under his leadership, the Company is continuing to build its research and development team to accelerate its internal activities.

Collaborations: Phio has established a number of strong collaborations with leading academic and corporate institutions. Results from several of these collaborators validate and build upon internal results for PH-762, supporting its progress toward clinical translation. In addition, the Company entered into new collaborations supporting the research and development of sd-rxRNA-based products beyond T-cells, including an agreement with Glycostem Therapeutics BV to support the evaluation of sd-rxRNA in adoptive cell therapy using natural killer (NK) cells.

Pipeline Advancements: The Company’s current pipeline products are based on clinically validated targets. Lead product candidate PH-762 is designed to elicit checkpoint blockade by inhibiting PD-1 receptor expression in T cells. Internal data, and data generated by collaborators, showed that silencing mRNA for PD-1 with PH-762 results in enhanced T cell activation and tumor cytotoxicity. Based on these positive preclinical results, Phio is advancing PH-762 for two distinct clinical applications: one for use in adoptive cell transfer of T cells and one for direct administration within the tumor micro-environment. The Company expects to start clinical studies for both of these pipeline products based on PH-762 in 2020.

The Company’s next pipeline product, PH-804, is designed to silence the expression of immune exhaustion target TIGIT by NK cells and T cells resulting in them becoming "weaponized." To date, Phio has shown that reduction of TIGIT by PH-804 leads to an increase in the cytotoxic capacity of NK cells. The Company plans to enter the clinic with PH-804 in the second half of 2020.

To further support the development of Phio’s immuno-oncology pipeline, the Company is working to validate and prioritize additional pipeline products focusing on adoptive cell therapy, the tumor micro-environment, as well as direct tumor applications. The Company’s additional pipeline products include sd-rxRNA compounds that impact the PD-1/PD-L1 axis and compounds that otherwise increase immune cell activity, for example by improving cell metabolism (e.g. increased spare respiratory capacity) and by impacting cell differentiation. We expect to advance additional sd-rxRNA candidates into preclinical and clinical development in the second half of 2019.

Corporate Developments: The Company entered into a purchase agreement with Lincoln Park Capital Fund, LLC ("Lincoln Park") on August 7, 2019, in which the Company has the right to sell to Lincoln Park up to $10 million in shares of the Company’s common stock, subject to the terms of the agreement. This investment by Lincoln Park is a continuation of its prior investment in the Company. The Company believes that this will provide the Company with access to capital at more favorable terms, as the Company controls the timing and amount of any future sales to Lincoln Park, while also providing Phio with a flexible funding option to advance its immuno-oncology programs into the clinical development phase.
Select Quarterly Financial Results

Cash Position

At June 30, 2019, the Company had cash of $10.8 million as compared with $14.9 million at December 31, 2018. The Company expects its cash to provide funding for at least the next twelve months.

Research and Development Expenses

Research and development expenses for the quarter ended June 30, 2019, were $1.1 million as compared with $1.2 million for the quarter ended June 30, 2018. The decrease was primarily due to a reduction in licensing fees.

General and Administrative Expenses

General and administrative expenses for the quarter ended June 30, 2019, were $0.9 million as compared with $0.8 million for the quarter ended June 30, 2018. The increase was primarily due to an increase in legal fees.

Net Loss

Net loss for the quarter ended June 30, 2019, was $2.0 million or $0.08 per share, compared with $1.9 million or $0.46 per share for the quarter ended June 30, 2018. The increase was primarily due to changes in operating expenses, as discussed above.