On August 7, 2020 Veracyte, Inc. (Nasdaq: VCYT) reported the closing of its public offering of 6,900,000 shares of common stock, including 900,000 shares sold upon full exercise of the underwriters’ option to purchase additional shares, at a price to the public of $30.00 per share (Press release, Veracyte, AUG 7, 2020, View Source [SID1234563226]). The net proceeds to Veracyte from the offering were approximately $194 million, after deducting underwriting discounts and commissions and estimated offering expenses.

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Goldman Sachs & Co., LLC and SVB Leerink LLC acted as joint lead book-running managers for the offering. William Blair & Company, L.L.C. acted as a book-running manager and BTIG, LLC, Needham & Company, LLC, and Lake Street Capital Markets, LLC acted as co-managers.

The public offering was made pursuant to an effective shelf registration statement filed with the Securities and Exchange Commission on May 2, 2019. This offering was made solely by means of a prospectus supplement and accompanying prospectus relating to and describing the terms of the offering, copies of which may be obtained by contacting Goldman Sachs & Co. LLC, Attention: Prospectus Department, 200 West Street, New York, NY 10282, by email at [email protected], or by telephone at (866) 471-2526; or SVB Leerink LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, Massachusetts 01220, by email at [email protected], or by telephone at (800) 808-7525, ext. 6218.

On August 7, 2020 Jounce Therapeutics, Inc. (NASDAQ: JNCE), a clinical-stage company focused on the discovery and development of novel cancer immunotherapies and predictive biomarkers, reported financial results for the second quarter ended June 30, 2020 and provided a corporate update (Press release, Jounce Therapeutics, AUG 7, 2020, View Source [SID1234563151]).

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"We made great strides in the second quarter and this year as a whole has proven to be a time of execution and important foundational work in advance of important future milestones. Of note, we completed EMERGE enrollment to support the interim analysis despite the challenges of the COVID-19 pandemic, and are on track for the interim analysis of efficacy and biomarker data in early 2021. We also expect to initiate enrollment this year of the Phase 1 trial for JTX-8064, an inhibitor of the LILRB2 receptor (or ILT4) on macrophages," said Richard Murray, Ph.D., chief executive officer and president of Jounce Therapeutics. "We continue to build a leading immuno-oncology company, focusing on the importance of deeply rooted science, translational analyses and well-informed clinical trial design. We look forward to continuing to execute on our milestones as we progress our broad pipeline of clinical and preclinical programs to bring the right immunotherapies to the right patients."

Pipeline Update:

Clinical Programs: Vopratelimab and JTX-4014

Completed enrollment to support interim analysis of Phase 2 EMERGE trial: Enrollment of patients with non-small cell lung cancer (NSCLC) who have progressed on or after both a platinum-based regimen and a PD-1 or PD-L1 inhibitor to support the interim analysis of the Phase 2 EMERGE trial is complete. Jounce is on track to complete this analysis of preliminary efficacy and biomarker data on more than 40 evaluable patients at different doses in early 2021.

Phase 2 SELECT trial initiation on track: Jounce remains on track to initiate the randomized Phase 2 SELECT trial to evaluate vopratelimab in combination with JTX-4014, a PD-1 inhibitor, versus JTX-4014 alone in immunotherapy naïve TISvopra biomarker selected, second line NSCLC patients. Jounce expects to enroll approximately 75 patients outside the U.S. and expects to report clinical data in 2021.

Presented vopratelimab translational data at the American Association for Cancer Research (AACR) (Free AACR Whitepaper): In June 2020, Jounce presented new translational data on vopratelimab at the AACR (Free AACR Whitepaper) Virtual Annual Meeting detailing important characteristics of ICOS hi CD4 T cells associated with vopratelimab treatment that may contribute to durable clinical responses in monotherapy and combination. The ICOS hi CD4 T cell population within peripheral blood of ICONIC responders is comprised of Th1, T central memory (Tcm) and T follicular helper (Tfh) subsets, which may contribute to direct anti-tumor effects as well as durability of clinical responses. Jounce has found that the generation of these functionally specialized subsets of CD4 cells does not occur with PD-1 inhibitors. The T cell central memory cells are consistent with a role for vopratelimab in durable clinical benefit.
Preclinical Development Programs: JTX-8064 and JTX-1811

Regained worldwide rights to JTX-8064 and on track to initiate Phase 1 clinical trial: In June 2020, Jounce announced that it regained the worldwide rights to JTX-8064 from Bristol Myers Squibb. JTX-8064 is a highly-selective, potential first-in-class antibody that targets the Leukocyte Immunoglobulin Like Receptor B2 (LILRB2 or ILT4) on macrophages, and was previously licensed to Celgene in July 2019. As part of its Celgene integration process, Bristol Myers Squibb has streamlined its pipeline and addressed areas of overlap. As a result, Bristol Myers Squibb notified Jounce that the JTX-8064 License Agreement was being terminated. JTX-8064 is the first tumor-associated macrophage candidate to emerge from Jounce’s Translational Science Platform. When LILRB2 (ILT4) binds to HLA molecules, including HLA-G, on cancer cells and macrophages, it induces an immunosuppressive state in the macrophages. JTX-8064 inhibits this immunosuppressive interaction, reprogramming the macrophages to a more immuno-stimulatory state. Jounce expects to begin enrollment in the Phase 1 dose escalation trial of JTX-8064 in 2020.

Presented new JTX-1811 preclinical data at AACR (Free AACR Whitepaper): In June 2020, Jounce introduced its JTX-1811 program at the AACR (Free AACR Whitepaper) Virtual Annual Meeting with preclinical data demonstrating that by selectively eliminating tumor infiltrating T regulatory cells (T regs), Jounce believes it can eliminate the immunosuppressive effect of these cells. Importantly, this biology may be independent of PD-1. In mouse tumor models, targeting and eliminating CCR8 positive T regs in the tumor showed single agent activity for JTX-1811 where PD-1 inhibitors did not, and showed an ability to restore PD-1 inhibitor responsiveness. Evaluation of T regs in human tumors versus blood showed the enriched expression of CCR8, allowing the establishment of an optimal window for depletion of T regs in the tumor. Jounce plans to continue IND-enabling activities for JTX-1811 and remains on track to file an Investigational New Drug, or IND, in the first half of 2021.
Second Quarter 2020 Financial Results:

Cash position: As of June 30, 2020, cash, cash equivalents and investments were $127.2 million, compared to $170.4 million as of December 31, 2019. The decrease in cash, cash equivalents and investments was primarily due to operating expenses incurred during the period.

License and collaboration revenue: Jounce did not recognize any revenue in the second quarter of 2020. License and collaboration revenue recognized during the second quarter of 2019 was comprised solely of non-cash revenue recognition related to the original strategic collaboration with Celgene which ended in July 2019.

Research and development expenses: Research and development expenses were $21.0 million for the second quarter of 2020, compared to $18.1 million for the same period in 2019. The increase in research and development expenses was primarily due to increased external clinical and regulatory costs associated with the EMERGE and SELECT clinical trials and increased employee compensation costs, partially offset by decreased IND-enabling expenses.

General and administrative expenses: General and administrative expenses were $7.2 million for the second quarter of 2020, compared to $7.3 million for the same period in 2019. The decrease in general and administrative expenses was primarily due to decreased professional service fees.

Net loss: Net loss was $28.0 million for the second quarter of 2020, resulting in basic and diluted net loss per share of $0.82. Net loss was $7.0 million for the same period in 2019, resulting in a basic and diluted net loss per share of $0.21. The increase in net loss and net loss per share was primarily attributable to a decrease in license and collaboration revenue and an increase in operating expenses.
Financial Guidance:

Based on its current operating and development plans, Jounce continues to expect gross cash burn on operating expenses and capital expenditures for the full year 2020 to be approximately $80.0 million to $95.0 million.

Jounce expects its existing cash, cash equivalents and investments to be sufficient to enable the funding of its operating expenses and capital expenditure requirements through the end of 2021.

Conference Call and Webcast Information:

Jounce Therapeutics will host a live conference call and webcast today at 8:00 a.m. ET. To access the conference call, please dial (866) 916-3380 (domestic) or (210) 874-7772 (international) and refer to conference ID 3898328. The live webcast can be accessed under "Events & Presentations" in the Investors and Media section of Jounce’s website at www.jouncetx.com. The webcast will be archived and made available for replay on Jounce’s website approximately two hours after the call and will be available for 30 days.

On August 7, 2020 Qualigen Therapeutics, Inc. (NASDAQ: QLGN) (Qualigen or the Company) reported that it will host a business update conference call and live webcast on Tuesday, August 18, 2020 at 4:30 p.m. Eastern time (Press release, Qualigen, AUG 7, 2020, View Source [SID1234563208]). During the call, Qualigen’s management team will discuss the Company’s business strategy, review its drug development program and upcoming milestones, and provide a general business update. In addition, management will review its fiscal first quarter 2021 financials.

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Participants are encouraged to pre-register for the conference call using this link. Callers who pre-register will be given a conference passcode and unique PIN to gain immediate access to the call and bypass the live operator. Participants may register at any time, including up to and after the call start time. A webcast of the call may also be accessed at Qualigen’s Investor Relations page at Qualigen Business Update Conference Call. Those without internet access or unable to pre-register may dial in by calling 1-866-777-2509 (U.S.) or 1-412-317-5413 (International).

A replay of the webcast will be available beginning approximately one hour after the completion of the live conference call at Qualigen Business Update Conference Call. A dial-in replay of the call will be available until August 25, 2020 by calling 1-877-344-7529 (U.S.) or 1-412-317-0088 (International) and providing the passcode 10147089.

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.