On August 7, 2020 ESSA Pharma Inc. ("ESSA", or the "Company") (NASDAQ: EPIX) (TSX-V: EPI), a clinical-stage pharmaceutical company focused on developing novel therapies for the treatment of prostate cancer, reported financial results for the fiscal third quarter ended June 30, 2020 (Press release, ESSA, AUG 7, 2020, View Source [SID1234563193]). All references to "$" in this release refer to United States dollars, unless otherwise indicated.

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"This past quarter has seen ESSA receive acceptance from the FDA and Health Canada to commence the clinical trial of EPI-7386, leading to the significant milestone of dosing the first patient in July," stated David Parkinson, MD, President and CEO of ESSA. Dr. Parkinson continued, "With the funds we have received from the recent financing, we believe we are in a very strong position to complete the Phase 1 dose escalation, expansion, and combination studies as planned."

Recent Corporate Highlights

On July 31st, the Company closed a public offering of common shares, led by Jefferies, as sole book-running manager, for gross proceeds of US$48,990,000. Certain existing investors participated in the financing along with new investors: Pfizer Inc. (NYSE: PFE), Avidity Partners, CAM Capital, Point72, Ridgeback Capital, Sphera Healthcare,Vivo Capital, and others.

On July 15th, the Company announced that the first patient had been dosed in a Phase 1 clinical trial designed to evaluate the safety and tolerability of EPI-7386 in mCRPC patients who failed standard of care treatments, including second generation anti-androgens. The trial, to be conducted at five sites in the United States and Canada, is expected to enroll approximately 18 patients in a standard 3+3 trial design with an approximate 10 additional patients enrolled in the dose expansion cohort. Funds from the recent financing will support multiple combination studies with existing anti-androgen drugs.

On June 22nd , the Company presented new preclinical data on ESSA’s clinical candidate, EPI-7386, at the 2020 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Virtual Annual Meeting II. In an oral poster presentation titled, "Pre-clinical development of the second-generation N-terminal domain androgen receptor inhibitor, EPI-7386, for the treatment of prostate cancer", results from preclinical studies of EPI-7386 including studies evaluating androgen receptor binding, gene expression analyses and the toxicologic profile were presented.
Summary Financial Results

Net Income (Loss). ESSA recorded a net loss of $4.9 million ($0.24 loss per common share based on 20,824,568 weighted average common shares outstanding) for the quarter ended June 30, 2020, compared to a net loss of $3.3 million ($0.52 loss per common share based on 6,383,737 weighted average common shares outstanding) for the quarter ended June 30, 2019. This included non-cash share-based payments of $1.5M for the quarter ended June 30, 2020 compared to $255,365 for the quarter ended June 30, 2019, recognized for stock options granted and vesting.

Research and Development ("R&D") expenditures. R&D expenditures for the quarter ended June 30, 2020 were $2.7 million compared to $1.95 million for the quarter ended June 30, 2019. The increase in R&D expenditures for the quarter were primarily related to preparing the IND application for EPI-7386, preparatory clinical costs, manufacturing and chemistry costs, and non-cash costs related to share-based payments ($382,941 for quarter ending June 30, 2020 compared to $72,306 for quarter ended June 30, 2019). R&D costs in the comparative period were primarily related to preclinical research of the Company’s next-generation aniten compounds.

General and administration ("G&A") expenditures. G&A expenditures for the quarter ended June 30, 2020 were $2.2 million compared to $1.2 million for the quarter ended June 30, 2019. The increase in the quarter is primarily due to non-cash share-based payments. ($1.1M for quarter ending June 30, 2020 compared to $183,059 for the quarter ending June 30, 2019.)
Liquidity and Outstanding Share Capital

Cash on hand at June 30, 2020 was $36.5 million, with working capital of $36.5 million, reflecting the aggregate gross proceeds of the August 2019 financing of $36 million and the acquisition of Realm Therapeutics plc which provided the Company with $22.2 million in cash, less operating expenses in the intervening period.

As of June 30, 2020, the Company had 20,841,261 common shares issued and outstanding.

In addition, as of June 30, 2020, there were 12,331,127 common shares issuable upon the exercise of warrants and broker warrants. This includes 11,919,404 prefunded warrants at an exercise price of $0.0001 that were issued in lieu of common shares in the August 2019 financing, and 411,723 other warrants at a weighted average exercise price of $38.93. There are 5,309,584 common shares issuable upon the exercise of outstanding stock options at a weighted-average exercise price of $3.42 per common share.

On August 7, 2020 Pulmatrix, Inc. (NASDAQ: PULM), a clinical stage biopharmaceutical company developing innovative inhaled therapies to address serious pulmonary and non-pulmonary disease using its patented iSPERSE technology, reported its Q2 2020 financial results and provides a business update (Press release, Pulmatrix, AUG 7, 2020, View Source [SID1234563191]).

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"The second quarter has been marked with important progress for our strategic partnership with Sensory Cloud," said Ted Raad, Chief Executive Officer of Pulmatrix. "The recent publication of data demonstrating the ability of FEND to suppress the exhalation of respiratory droplets, which can transmit airborne infections, leaves us confident that our proprietary NasoCalm technology can be applied to provide an important new OTC hygiene option for addressing the spread of COVID-19. We look forward to an anticipated commercial launch in the fall of this year and believe the royalty stream from the commercialization of FEND, upon the commencement of sales, could be an important source of non-dilutive funding to fuel our internal development pipeline."

Mr. Raad continued, "Together with our partner Cipla, we decided to end our Phase 2 clinical study of Pulmazole for the treatment of asthma patients with ABPA. We are leveraging this pause in our development program to prepare for a new Phase 2b study of longer study duration and inclusion of efficacy endpoints that are intended to better inform and propel the program forward. While we prepare for a potential study start in 3Q 2021, we are working with Cipla to amend the Phase 2 development and commercialization agreement to include the new Phase 2b development plan and budget. In our partnership with Johnson & Johnson, we achieved a significant milestone with the MRHA approval of the PUR1800 Ph1b study, enabling us to start the study in 2H 2020."

Q2 and Recent Highlights:

Announced partner Sensory Cloud’s progress towards the commercialization of FEND, an over the counter (OTC) nasal hygiene product that is comprised of proprietary Pulmatrix NasoCalm formulations (PUR003 and PUR006) of sodium chloride and calcium chloride salts licensed from Pulmatrix. FEND is designed to provide, among other potential benefits, an ability to suppress the exhalation of droplets of airway lining fluid, which can transmit airborne infection with an anticipated commercial launch in the fall of 2020. Pulmatrix will receive escalating royalties from worldwide revenues upon commencement of sales.
Announced the publication of NasoCalm development data, along with data generated by Sensory Cloud, in the Quarterly Reviews of Biophysics, demonstrating a reduction in airborne particles in exhaled air over time following FEND administration. These data suggest FEND provides hygienic benefit that may augment current social distancing and hygiene measures for addressing the spread of COVID-19 and other airborne pathogens.
Due to past enrollment delays, coupled with the impact of the COVID-19 pandemic on enrollment, Pulmatrix and Cipla ended its Phase 2 clinical study of Pulmazole for the treatment of allergic bronchopulmonary Aspergillosis (ABPA). Pulmatrix intends to initiate a new Phase 2b clinical study in 3Q 2021 with up to four months of dosing and the addition of trial efficacy endpoints, replacing the Phase 2 clinical study which focused on safety and tolerability endpoints. Top-line data is anticipated 18 months after site activation start. Due to the changes in the development of Pulmazole, Pulmatrix and Cipla are negotiating amendments to the development and commercialization agreement.
The Medicines and Healthcare Products Regulatory and Approval Agency (MHRA) approved in July the PUR1800 Ph1b clinical trial, enabling Pulmatrix plans to begin the study in the United Kingdom during 2H 2020.
Appointed Chris Cabell, M.D. to the Pulmatrix Board of Directors. As current Head of Research & Development and Chief Medical Officer at Arena Pharmaceuticals, with prior experience as Chief Medical and Scientific Officer at Quintiles, Dr. Cabell possesses the critical skills that will be beneficial in the strategy for Pulmatrix pipeline programs. Steven Gills, Ph.D., will step down from the Board of Directors on September 1, 2020.
Strengthened balance sheet with gross proceeds from a registered direct offering in April and a warrant exercise transaction in July, in order to support ongoing preclinical and anticipated clinical programs for Pulmazole, PUR1800, other pipeline assets and general working capital needs.
Financials

As of June 30, 2020, Pulmatrix had $27.3 million in cash compared to $23.4 million as of December 31, 2019.

Pulmatrix generated $3.5 million of revenue in the second quarter of 2020, compared to $4.8 million in the second quarter of 2019. The revenue for the first quarter of 2020 was the result of the collaboration and licensing agreements with Cipla and JJEI, respectively.

Research and development expenses for the second quarter of 2020 and 2019 were $3.2 million. Included in the second quarter of 2020 costs were pre-clinical toxicology costs for the PUR1800 program and clinical study costs incurred for the Phase 2 Pulmazole study.

General and administrative expenses for the second quarter of 2020 were $1.5 million compared to $3.1 million in the second quarter of 2019. The decrease of $1.6 million was due to decreased spend in employment costs primarily as a result of reduced share-based compensation expense of $1.1 million in 2020, a $0.3 million milestone payment in 2019 and a $0.2 million reduction in legal and patent expense in 2020.

Net loss was $1.2 million for the first quarter of 2020 and $7.8 million for the first quarter of 2019. The net loss for both periods was due to spend on the Pulmazole study and PUR1800 manufacturing costs for the upcoming planned Phase 1b clinical study.

On August 7, 2020 Guardant Health reported the U.S. Food and Drug Administration (FDA) has approved liquid biopsy, Guardant360 CDx, for tumor mutation profiling in patients across all solid cancers (Press release, Guardant Health, AUG 7, 2020, View Source [SID1234563190]).

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For Guardant Health Asia, Middle East and Africa (AMEA), this FDA approval represents a landmark achievement for the Guardant360 test. Currently, the liquid biopsy is commercially available in 41 countries in AMEA. For advanced cancer patients, this FDA approval lends even greater credibility to the test and its ability to provide comprehensive genomic profiling information that is critical to their cancer treatment.

"This FDA approval is a significant milestone for us and it will certainly boost our efforts in offering Guardant360 as the preferred liquid biopsy option in AMEA. We remain committed to making the Guardant360 test available to as many advanced cancer patients as possible so that they can undergo complete genotyping and have the best opportunity to receive the right treatment for their cancer," said Mr Simranjit Singh, Chief Executive Officer of Guardant Health AMEA.

"The US FDA approval validates the technology behind the Guardant360 assay that we offer to advanced stage cancer patients in AMEA. Treatment guidelines recommend testing for more than 20 different genomic biomarkers. Evaluating each mutation individually wastes time and delays treatment. With Guardant360, physicians and patients can feel confident that relevant genes are being assessed with a single blood test. Results are available within 7 days from receipt in the laboratory. This will help more patients start treatment sooner with appropriate precision cancer medicines," said Dr. Steve Olsen, Chief Medical Officer of Guardant Health AMEA.

Guardant Health AMEA hopes to accelerate wider adoption of guideline-recommended genomic profiling in clinical practice among medical oncologists so that advanced cancer patients in AMEA can benefit from reliable and comprehensive liquid biopsies such as Guardant360 and be treated quickly and accurately.

On August 7, 2020 Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) reported the pricing of an underwritten offering of $1.250 billion aggregate principal amount of senior unsecured notes due 2030 (the "2030 notes") and $750 million aggregate principal amount of senior unsecured notes due 2050 (the "2050 notes" and, together with the 2030 notes, the "notes") (Press release, Regeneron, AUG 7, 2020, View Source [SID1234563189]). The 2030 notes will bear interest at 1.750% per annum and will mature on September 15, 2030. The 2050 notes will bear interest at 2.800% per annum and will mature on September 15, 2050. The issuance of the notes is expected to close on or around August 12, 2020, subject to customary closing conditions.

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Regeneron intends to use the net proceeds from the offering to repay in full the $1.5 billion principal amount of loans outstanding under the bridge facility incurred to fund a portion of the repurchase by Regeneron of shares of its common stock held by Sanofi in May 2020, and to pay accrued interest and related fees and expenses in connection therewith. The remainder will be used for other general corporate purposes.

Goldman Sachs & Co. LLC, BofA Securities, and J.P. Morgan are acting as joint book-running managers for the offering. US Bancorp, Barclays, Citigroup, Fifth Third Securities, and MUFG are also acting as book-running managers for the offering. Bank of Ireland, Citizens Capital Markets, Loop Capital Markets, and PNC Capital Markets LLC are acting as co-managers for the offering. Regeneron has filed a registration statement (including a prospectus) with the Securities and Exchange Commission (the "SEC") for the offering. Before you invest, you should read the prospectus in that registration statement and other documents Regeneron has filed and will file with the SEC, including the preliminary prospectus supplement filed by Regeneron with the SEC, for more complete information about Regeneron and this offering. You may get these documents for free by visiting EDGAR on the SEC website at www.sec.gov. Alternatively, any underwriter or any dealer participating in the offering will arrange to send you the prospectus and the preliminary prospectus supplement, when available, if you request them by contacting Goldman Sachs & Co. LLC, Attention: Prospectus Department, 200 West Street, New York, New York 10282, via telephone: (866) 471-2526, or via email: [email protected], BofA Securities, NC1-004-03-43, 200 North College Street, 3rd Floor, Charlotte, NC 28255-0001, Attention: Prospectus Department or by email at [email protected], and J.P. Morgan, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717 or toll free at (866) 803-9204.

On August 7, 2020 Illumina, Inc. (NASDAQ:ILMN) reported that its executives will be speaking at the following investor conference and invited investors to participate via webcast (Press release, Illumina, AUG 7, 2020, View Source [SID1234563188]).

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UBS Genomics 2.0 and MedTech Innovations Virtual Summit
Wednesday, August 12, 2020 at 10:00am Pacific Time

The live webcasts can be accessed in the Investor Info section of Illumina’s web site under the "company" tab at www.illumina.com. A replay of the presentations will be posted on Illumina’s website after the event and will be available for at least 30 days following.