On August 9, 2018 ChemoCentryx, Inc., (Nasdaq:CCXI), reported financial results for the second quarter ended June 30, 2018 and provided an overview of the Company’s recent corporate highlights (Press release, ChemoCentryx, AUG 9, 2018, View Source [SID1234528752]).

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"A most important milestone has recently been achieved at ChemoCentryx: we completed enrollment of over 300 patients in our landmark ADVOCATE Phase III trial in ANCA-associated vasculitis," said Thomas J. Schall, Ph.D., President and Chief Executive Officer of ChemoCentryx. "We’re targeting the fourth quarter of 2019 for the release of top-line data from ADVOCATE, and expect that successful trial results would form the basis of our new drug application to the FDA. Our very healthy balance sheet also enables us to simultaneously pursue other high unmet need, high value disease indications. Specifically, controlled clinical trials are underway for avacopan in C3G and for our other innovative kidney asset, CCX140 in FSGS. These are all orphan renal diseases with no approved therapies. Our plan to expand into orphan dermatological disease is also progressing extremely well. We intend to launch a large controlled clinical trial of avacopan in hidradenitis suppurativa later this year. In sum, 2018 is shaping up to be a watershed year for the Company, and we believe our momentum is building."

Recent Highlights

ChemoCentryx has completed enrollment of 316 patients in the Phase III ADVOCATE pivotal trial of avacopan for the treatment of ANCA-associated vasculitis. The trial will evaluate the safety and efficacy of avacopan following 52 weeks of treatment.

Expanded commercial alliance with Vifor Pharma to provide Vifor with commercialization rights in China for avacopan and CCX140, in exchange for upfront cash payments to ChemoCentryx totaling $21.5 million, plus tiered royalties between the teens and mid-twenties on potential net future sales in the Vifor territories.

Surpassed 45% of the patient enrollment target in the Company’s clinical trial evaluating avacopan for C3G. C3G is a rare disorder that often affects the young, requiring dialysis and often kidney transplant with relapsing disease common. There is no approved effective treatment.

Reported $91.5MM in cash receipts year-to-date; current balance sheet >$200MM in cash and equivalents.

Developed plan to launch clinical trials by the end of 2018 of avacopan in HS, an inflammatory and chronic skin disease characterized by recurrent, painful, boil-like nodules under the skin.

Launched clinical development of CCR2 inhibitor CCX140 in two sub-populations of primary FSGS, an orphan kidney disease with no approved treatment option.

Second Quarter 2018 Financial Results

Cash, cash equivalents and investments totaled approximately $201.8 million at June 30, 2018. In the first six months of 2018, ChemoCentryx received $91.5 million in cash from milestone and upfront payments and credit facility advances. Cash utilized for the first six months of the year was $25MM. For the full year, the Company expects to utilize cash and investments between $60 million and $70 million.

Revenue was $15.0 million for the second quarter of 2018, compared to $8.9 million for the same period in 2017. Revenue recognized represents amortization of the upfront license fee commitments, milestone payments and collaboration funding from Vifor pursuant to the Avacopan Agreement, Avacopan Amendment and CCX140 Agreement. The increase from 2017 to 2018 was primarily due to the Company’s adoption of Accounting Standards Codification (ASC) Topic 606, Revenue from Contracts with Customers effective January 1, 2018.

Research and development expenses were $17.8 million for the second quarter of 2018, compared to $14.3 million for the same period in 2017. The increase from 2017 to 2018 was primarily due to the patient enrollment of the avacopan Phase II clinical trial in patients with C3G and start-up expenses related to the CCX140 Phase II clinical trials in patients with FSGS.

General and administrative expenses were $4.7 million for the second quarter of 2018, compared to $4.2 million for the same period in 2017. The increase from 2017 to 2018 was primarily due to higher employee-related expenses, including those associated with our commercialization planning efforts, partially offset by a decrease in professional fees.

Net loss for the second quarter of 2018 was $6.9 million, compared to $9.2 million for the same period in 2017.

Total shares outstanding at June 30, 2018 were approximately 50.3 million shares.

Conference Call and Webcast

The Company will host a conference call and webcast today, August 9, 2018 at 5:00 p.m. Eastern Time / 2:00 p.m. Pacific Time. To participate by telephone, please dial 877-303-8028 (Domestic) or 760-536-5167 (International). The conference ID number is 6238899. A live and archived audio webcast can be accessed through the Investors section of the Company’s website at www.ChemoCentryx.com. The archived webcast will remain available on the Company’s website for fourteen (14) days following the conference call.

On August 9, 2018 Regulus Therapeutics Inc. (Nasdaq: RGLS), a biopharmaceutical company focused on the discovery and development of innovative medicines targeting microRNAs, reported financial results for the second quarter ended June 30, 2018 and provided a summary of recent events (Press release, Regulus, AUG 9, 2018, View Source [SID1234528589]).

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Second Quarter 2018 and Recent Updates

Corporate Updates

Corporate restructuring: In July 2018, the Company announced a corporate restructuring and workforce reduction of approximately 60% in order to focus its pipeline and extend its cash runway, the activities of which have been substantially completed. In connection with the restructuring, the Company expects to record net charges of approximately $0.8 million for employee severance and other related termination benefits. As a result of the restructuring, the Company’s annual cash burn is expected to be reduced by approximately 50% by year-end, inclusive of debt service costs.
Pipeline Updates

RGLS4326 for autosomal dominant polycystic kidney disease (ADPKD): As previously announced, due to unexpected observations in its 27-week mouse chronic toxicity study, and in consultation with FDA, the Company plans to initiate a new mouse chronic toxicity study with certain changes that are believed to address the unexpected observations. Importantly, RGLS4326 has been generally safe and well-tolerated in humans in the Phase 1 single ascending dose (SAD) and multiple ascending dose (MAD) studies to date. The Company has voluntarily paused dosing in the Phase 1 MAD study, pending results from the new chronic mouse toxicity study.
Advancement of Hepatitis B virus (HBV) Programs: The Company has determined that advancing its preclinical programs targeting HBV, which affects an estimated 350 million people worldwide, represents the most attractive investment opportunity in its preclinical pipeline. Regulus has identified multiple microRNA targets that serve as host factors for the virus. Targeting host factors with GalNAc-conjugated oligonucleotides directed to the liver represents a potentially attractive approach to treating the disease. Regulus and others have already demonstrated effective delivery to the liver with this technology, and Regulus has demonstrated human proof-of-concept (POC) with this approach previously with a program targeting the Hepatitis C virus. The Company currently expects to file an IND for the HBV program in H2 2019, with the potential of achieving human POC in a Phase 1 study.
RG-012 Program in Alport syndrome: In July 2018, the Company announced it had paused recruitment activities for the RG-012 program in Alport syndrome while it undertook discussions with Sanofi to potentially restructure the partnership. The Company also announced that preliminary results from the first patients through the renal biopsy study were encouraging with kidney tissue concentrations achieved that would be predictive of therapeutic benefit based on animal disease models. In addition, modulation of the target, miR-21, was observed.
Financial Updates

Amendment to Term Loan: In August 2018, the Company and Oxford entered into an amendment to the Term Loan, providing for an additional three-month interest-only period, commencing August 2018 through October 2018. Under the previous terms of the Term Loan, principal payments were due over this 3-month period totaling $2.5 million. Amortization payments will recommence in November 2018. The amendment contains a minimum cash reserve covenant, in addition to a security interest in our intellectual property as additional collateral for the repayment of the Term Loan. In the event we reduce the principal balance of the Term Loan to $10.0 million or less on or before November 1, 2018, the cash reserve covenant described above would no longer apply. There were no changes to the maturity date of the Term Loan, which is June 2020.
"The recent period has been highlighted by a challenging set of circumstances and unexpected setbacks, however we remain committed to our specific near-term objectives, namely coming to an agreement with Sanofi concerning the development of the Alport syndrome program, advancing our investigative and preclinical work on RGLS4326 to enable the Phase 1 MAD to resume, advancing our HBV programs, extending our cash runway, and looking for additional ways to improve shareholder value," said Jay Hagan, President and Chief Executive Officer of Regulus.

Financial Results

Cash Position: As of June 30, 2018, Regulus had cash, cash equivalents and short-term investments of $32.9 million.

Research and Development (R&D) Expenses: R&D expenses were $10.0 million and $21.8 million for the three and six months ended June 30, 2018, respectively, compared to $14.3 million and $30.0 million for the same periods in 2017. The decreases were primarily attributable to reductions in program-related spend for RG-101 and RGLS5040, as these programs were discontinued in 2017, in addition to reductions in personnel-related costs.

General and Administrative (G&A) Expenses: G&A expenses were $3.3 million and $7.1 million for the three and six months ended June 30, 2018, respectively, compared to $7.1 million and $11.0 million for the same periods in 2017. The decreases were primarily attributable to non-recurring severance and non-cash stock-based compensation charges in Q2 2017.

Net Loss: Net loss was $13.8 million, or $0.13 per share (basic and diluted), and $29.9 million, or $0.29 per share (basic and diluted), for the three and six months ended June 30, 2018, respectively, compared to $21.6 million, or $0.41 per share (basic and diluted), and $41.6 million, or $0.78 per share (basic and diluted), for the same periods in 2017.

On August 9, 2018 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 and provided a corporate update for the second quarter ended June 30, 2018 (Press release, Jounce Therapeutics, AUG 9, 2018, View Source;p=RssLanding&cat=news&id=2363021 [SID1234528610]).

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"We recently reported safety and preliminary efficacy data from our lead program, JTX-2011, at ASCO (Free ASCO Whitepaper) in June and are pleased to announce that enrollment is now underway in the dose escalation cohorts of the Phase 1/2 ICONIC trial evaluating the safety of JTX-2011 in combination with ipilimumab and in combination with pembrolizumab. For the broader pipeline derived from our Translational Science Platform, we remain on track to file an IND for JTX-4014 this year and are conducting IND-enabling studies for our first tumor-associated macrophage candidate," said Richard Murray, Ph.D., chief executive officer and president of Jounce Therapeutics. "Our experienced and talented team remains focused on our key value drivers as we work to discover and develop first-in-class immunotherapies. We remain committed to interrogating the tumor microenvironment to inform and refine our clinical trials and, ultimately, impact the lives of cancer patients."

Ongoing Phase 1/2 ICONIC Trial of JTX-2011:

In June 2018, Jounce began enrollment of dose escalation cohorts evaluating the safety of JTX-2011 in combination with ipilimumab and in combination with pembrolizumab.

In June 2018, Jounce presented safety and preliminary efficacy data from its ongoing Phase 1/2 ICONIC (ICOS AgONist Antibody for Immunotherapy in Cancer Patients) trial, an adaptive design, open-label trial evaluating JTX-2011 alone and in combination with nivolumab in patients with advanced solid tumors. The Phase 1 portion of ICONIC was a dose escalation study to determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D). The patients in Phase 2 received JTX-2011 0.3 mg/kg every 3 weeks alone or in combination with nivolumab 240 mg every 3 weeks. Preliminary efficacy evaluation included tumor reductions and response evaluation criteria in solid tumors (RECIST) responses. Key data included:

Safety: JTX-2011 was well tolerated alone and in combination with nivolumab 240 mg every 3 weeks. The overall safety profile observed was consistent with previously reported data from the Phase 1 portion of the ICONIC trial.

Biological and Clinical Activity: The patients with RECIST partial responses (PRs), alone and in combination with nivolumab, reported at ASCO (Free ASCO Whitepaper), remained on study with ongoing response. The RECIST PRs were seen in PD-1 inhibitor naïve patients with Gastric and Triple Negative Breast cancers. In addition, tumor reductions and stable disease have occurred including in patients with Non-Small Cell Lung cancers who are PD-1 inhibitor failures.

Biomarkers: In a preliminary analysis of evaluable fresh pre-treatment biopsies, rates of disease control and tumor reduction appear higher in subjects with high ICOS scores. A potential ICOS pharmacodynamic biomarker (emergence of a peripheral blood ICOS high CD4 T cell population) that appears to associate with anti-tumor activity has been identified.
Additional Pipeline Highlights:

Jounce remains on track to file an Investigational New Drug (IND) application for JTX-4014, its internal anti-PD-1 antibody in the second half of 2018.

In March 2018, Jounce advanced its first, tumor associated macrophage candidate from its Translational Science Platform into IND-enabling studies.
Second Quarter 2018 Financial Results:

Cash Position: As of June 30, 2018, cash, cash equivalents and investments were $232.7 million, compared to $257.9 million as of December 31, 2017. This decrease was due to operating costs incurred during the quarter, offset by the receipt of state and federal income tax refunds.

Collaboration Revenue: Collaboration revenue was $19.4 million for the second quarter of 2018, compared to $20.3 million for the same period in 2017. Collaboration revenue represents revenue recognition relating to the $225.0 million upfront payment received in July 2016 upon the execution of Jounce’s global strategic collaboration with Celgene. Under Accounting Standards Codification Topic 606, Revenue from Contracts with Customers, which was adopted in the first quarter of 2018, Jounce has transitioned from recognizing revenue on a straight-line basis to recognizing revenue based on the pattern of performance under the global strategic collaboration with Celgene. Jounce is reiterating its 2018 collaboration revenue guidance of approximately $50.0 to $60.0 million.

Research and Development (R&D) Expenses: R&D expenses were $18.5 million for the second quarter of 2018, compared to $17.2 million for the same period in 2017. The increase in R&D expenses was primarily due to $1.0 million in increased employee compensation costs related to increased headcount and $0.2 million in increased external research and development costs primarily attributable to IND-enabling activities related to JTX-4014.

General and Administrative (G&A) Expenses: G&A expenses were $6.5 million for the second quarter of 2018, compared to $6.1 million for the same period in 2017. The increase in G&A expenses was primarily due to increased stock-based compensation expense.

Net Loss: Net loss was $4.7 million for the second quarter of 2018, or a basic and diluted net loss per share attributable to common stockholders of $0.14. Net loss was $3.4 million for the same period in 2017, or a basic and diluted net loss per share attributable to common stockholders of $0.11. The increase in net loss per share attributable to common stockholders is primarily attributable to the decrease in non-cash collaboration revenue and the increase in operating expenses from the second quarter of 2017 to the second quarter of 2018.
Financial Guidance:

In March 2018, Jounce provided gross cash burn guidance for 2018 of $80.0 to $100.0 million. This cash burn projection excluded any tax refund impact. During the second quarter of 2018, Jounce received tax refunds of $16.8 million relating to taxes previously paid on the Celgene upfront payment. These refunds resulted from a change in tax accounting method elected as a result of the Tax Cuts and Jobs Act of 2017.

Jounce expects to now be at the lower end of the gross cash burn guidance previously provided and expects to end the year with approximately $185.0 to $195.0 million in cash, cash equivalents and investments. Jounce expects its existing cash, cash equivalents and investments to be sufficient to enable the funding of its operating expenses and capital expenditure requirements for at least the next 24 months.

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 8881737. The live webcast can be accessed under "Events & Presentations" in the Investors and Media section of the company’s website at www.jouncetx.com. The webcast will be archived and made available for replay on the company’s website approximately two hours after the call and will be available for 30 days.

Cautionary Note Regarding Forward-Looking Statements:

Various statements in this release concerning Jounce’s future expectations, plans and prospects, including without limitation, Jounce’s expectations regarding operating expenses, capital expenditures, collaboration revenue, cash burn and other financial results, the timing and progress of the Phase 1/2 ICONIC trial, the filing of an IND for JTX-4014 and the timing, progress and results of preclinical studies and clinical trials for Jounce’s product candidates and any future product candidates may constitute forward-looking statements for the purposes of the safe harbor provisions under The Private Securities Litigation Reform Act of 1995 and other federal securities laws and are subject to substantial risks, uncertainties and assumptions. You should not place reliance on these forward looking statements, which often include words such as "anticipate," "believe," "estimate," "expect," "intend," "may," "on track," "plan," "predict," "target," "potential" or similar terms, variations of such terms or the negative of those terms. Although the Company believes that the expectations reflected in the forward-looking statements are reasonable, the Company cannot guarantee such outcomes. Actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors, including, without limitation, Jounce’s ability to successfully demonstrate the efficacy and safety of its product candidates and future product candidates, the preclinical and clinical results for its product candidates, which may not support further development and marketing approval, the potential advantages of Jounce’s product candidates, the development plans of its product candidates, actions of regulatory agencies, which may affect the initiation, timing and progress of pre-clinical studies and clinical trials of its product candidates, Jounce’s ability to obtain, maintain and protect its intellectual property, Jounce’s ability to manage operating expenses, Jounce’s ability to maintain its collaboration with Celgene, as well as those risks more fully discussed in the section entitled "Risk Factors" in Jounce’s most recent annual or quarterly report and in other reports that Jounce has filed with the Securities and Exchange Commission. All such statements speak only as of the date made, and the Company undertakes no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise.

On August 9, 2018 Idera Pharmaceuticals, Inc. (NASDAQ: IDRA), a pharmaceutical company focused on the development and commercialization of its proprietary immune modulator, tilsotolimod, for the treatment of cancer, reported that the company will participate in a fireside chat, led by Vincent Milano Idera’s Chief Executive Officer at the 2018 Wedbush PacGrow Healthcare Conference on Tuesday, August 14, 2018 at 10:20 a.m. Eastern Time at the Parker Hotel in New York City (Press release, Idera Pharmaceuticals, AUG 9, 2018, View Source [SID1234528704]).

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Live audio webcast of Idera’s presentations will be accessible in the Investors and Media section of Idera’s website at View Source Archived versions will also be available on the Company’s website after the event for 90 days.

On August 9, 2018 Arbutus Biopharma Corporation (Nasdaq: ABUS), an industry-leading Hepatitis B Virus (HBV) therapeutic solutions company, reported that Dr. Michael Sofia, Arbutus’ Chief Scientific Officer, will present a corporate update at the Wedbush PacGrow Healthcare Conference on Wednesday, August 15, 2018 at 2:30 pm – 3:00 pm ET in New York (Press release, Arbutus Biopharma, AUG 9, 2018, View Source [SID1234528814]).

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A live webcast of the presentation can be accessed through the Investor section of Arbutus’ website at www.arbutusbio.com. A replay of the webcast will be available for 90 days following the live presentation.