On November 11, 2020 Salarius Pharmaceuticals, Inc. (Nasdaq: SLRX), a clinical-stage biopharmaceutical company developing potential new medicines for children and adults with pediatric cancers, solid tumors and other cancers, reported its corporate and financial results for the third quarter ended September 30, 2020 (Press release, Salarius Pharmaceuticals, NOV 11, 2020, View Source [SID1234570731]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Recent Business and Corporate Events:

Ewing sarcoma Phase 1/2 clinical trial is completing dose escalation to establish maximum tolerated dose (MTD) and is expected to advance into Phase 2 dose-expansion in Q1 2021
Ewing sarcoma clinical trial expansion phase expanded to include patients with Ewing-related sarcomas such as myxoid liposarcoma, desmoplastic small round cell tumors and other sarcomas with similar biology to Ewing sarcoma
º Ewing sarcoma and Ewing-related sarcomas represent rare cancers affecting both children and adults where there is a high unmet need for additional treatment options
Financial Highlights:

Total cash and cash equivalents of $9.6 million as of September 30, 2020 due in part to $6.2 million gross proceeds in an underwritten public offering closed August 3, 2020
Three-month period ended September 30, 2020 net loss per common share – basic and diluted – of $0.10, compared to $0.73 for the same period ended September 30, 2019
"The events of the third quarter of 2020 affirm the company’s growth strategy and demonstrate the potential of seclidemstat as a treatment for cancers with high unmet need," said David Arthur, President and CEO of Salarius. "Our lead clinical program in Ewing sarcoma continues to advance, and we expect to reach the maximum tolerated dose (MTD) in the Phase 1 portion of the clinical trial and, as planned, begin the Phase 2 dose-expansion portion of the trial in Q1 2021. This is an important milestone as it allows us to establish the recommended Phase 2 dosing regimen for the trial and begin treating a broader group of patients with Ewing and Ewing-related sarcomas."

Mr. Arthur continued, "Ewing sarcoma and advanced solid tumors (AST) remain our most advanced development programs, but we believe seclidemstat offers the opportunity to address numerous cancers where additional treatment options are needed. In this regard, we recently expanded the dose-expansion phase of the Ewing sarcoma clinical trial to include several additional sarcomas. This decision was based on preclinical data and early clinical data observations from the ongoing clinical trials that suggest seclidemstat may demonstrate drug activity and have applicability in other sarcomas that have a similar gene arrangement to Ewing sarcoma, known as Ewing-related sarcomas. Among those observations, Salarius previously disclosed that a refractory Ewing sarcoma patient treated with seclidemstat for six months demonstrated a reduction of over 80% in prospectively defined target lesions, which generally represent a patient’s largest measurable tumors."

Ewing Sarcoma Clinical Trial Expanded
On July 29, 2020, Salarius announced the expansion of its ongoing Phase 1/2 clinical trial of seclidemstat in Ewing sarcoma to include additional select sarcomas that share a similar biology to Ewing sarcoma, also known as Ewing-related sarcomas. Sarcomas of interest include myxoid liposarcoma, desmoplastic small round cell tumors and other sarcomas that harbor similar FET family gene rearrangements to Ewing sarcoma.

These Ewing-related sarcomas were chosen based on their underlying biology as well as preclinical data and early clinical observations involving seclidemstat that suggest the drug may demonstrate activity and may have applicability in several sarcomas that share key characteristics of Ewing sarcoma. As Salarius previously disclosed, a refractory Ewing sarcoma patient treated with seclidemstat for six months demonstrated a reduction of over 80% in prospectively defined target lesions. Target lesions generally represent a patient’s largest measurable tumors. However, at eight weeks, an increase in non-target lesions resulted in an overall patient classification of progressive disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST).

The amendment to the ongoing clinical trial will allow up to 30 patients with Ewing-related sarcomas to enroll in the trial’s upcoming dose-expansion phase, which is in addition to the 20 Ewing sarcoma patients also planned to be treated in the dose-expansion phase.

Additional Clinical Trials to Expand Development Program
Mr. Arthur concluded, "In addition, in the third quarter we continued preparatory work on two additional clinical trials and look forward to announcing the initiation of these trials soon. These additional clinical trials support our growth strategy focused on maximizing the market potential of seclidemstat."

Three-Month Financial Results:
For the three-month period ended September 30, 2020, Salarius’ reported net loss was $1.7 million, or $0.10 per basic and diluted share, compared to a net loss of $2.6 million, or $0.73 per basic and diluted share for the same period in 2019. The loss before other income for the three-month period ended September 30, 2020 decreased by $2.0 million compared to the same time span last year, primarily due to a $2.2 million decrease in general and administrative expenses which more than offset the increase of $0.7 million in research and development expenses. Increased research and development costs resulted from increased clinical trial expenses and drug manufacturing costs. The decrease in general and administrative costs resulted from the absence of costs related to Salarius’ one-time transformation into a public company during 2019 which did not reoccur in the current period.

As of September 30, 2020, total cash, cash equivalents and restricted cash were $9.6 million, compared to $3.7 million at year-end 2019. Increases in cash balances result from the Company’s public offerings of stock in the first quarter and third quarter 2020. The Company expects its cash and cash equivalents to fund its operations into the third quarter of 2021.

$6.2 Million Underwritten Public Offering
On August 3, 2020, Salarius completed an underwritten public offering with total gross proceeds of approximately $6.2 million, prior to deducting underwriting discounts and commissions and offering expenses payable by Salarius. Salarius intends to use the net proceeds from the offering and ongoing non-dilutive financial support from the Cancer Prevention Institute of Texas (CPRIT) to fund the expansion of the Ewing sarcoma clinical trial and ongoing company operations.

Conference Call Information:
Salarius Pharmaceuticals will host a conference call and live audio webcast on Wednesday, November 11, 2020, at 4:30 p.m. ET, to discuss its corporate and financial results for the third quarter 2020. Interested participants and investors may access the conference call by dialing either:

An audio webcast will be accessible via the Investors Events and Presentations section of the Company’s website View Source An archive of the webcast will remain available for 90 days beginning at approximately 5:30 p.m. ET, on November 11, 2020.

On November 11, 2020 Evotec SE reported results for the first nine months of 2020 and provides corporate update (Press release, Evotec, NOV 11, 2020, View Source;announcements/press-releases/p/evotec-se-reports-results-for-the-first-nine-months-of-2020-and-provides-corporate-update-5994 [SID1234570702])

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

HIGHLIGHTS
Continued strong performance in base business; robust revenue growth and improving EBITDA in Q3
Group revenues: 12% increase to € 360.4 m (9M 2019: € 321.4 m)
Significant like-for-like base revenue growth (adjusted for portfolio and FX) up 19%
Robust revenue growth in both segments: Total EVT Execute revenues up 14% to € 352.7 m (9M 2019: € 308.1 m); EVT Innovate revenues up 21% to € 74.7 m (9M 2019: € 61.8 m)
Adjusted Group EBITDA of € 76.9 m (9M 2019: € 93.2 m) with good momentum in Q3
Expanded investment in R&D with expenses of € 46.1 m (9M 2019: € 41.3 m); significant increase in unpartnered R&D of 30% to € 33.4 m (9M 2019: € 25.7 m)
No material impact of COVID-19 pandemic on overall financial and strategic development so far; slight delays in the conclusion of contracts and milestone achievements

EVT EXECUTE & EVT INNOVATE – MULTIMODALITY AND INTEGRATED PLATFORM SET FOR GROWTH IN DATA DRIVEN PRECISION MEDICINE
Multiple new and extended drug discovery and development agreements
Just – Evotec Biologics on track for success
Strategic alliance with Novo Nordisk to develop novel therapies for kidney diseases
Access to QUOD biobank to expand patient database into liver disease
Further milestone achieved in neurodegeneration alliance with Bristol Myers Squibb
Expanded collaboration with Centogene into Gaucher disease
Good progress in collaboration asset with Bayer – two clinical Phase II studies with P2X3 antagonist BAY1817080/ Eliapixant were initiated by Bayer in September/October (for one study patient recruitment started after period-end)
Important COVID-19 pandemic-related alliances with US DOD (Department of Defence) and grant from Bill & Melinda Gates Foundation (after period-end)

CORPORATE
Acquisition of the assets (mainly land and buildings) and takeover of staff from "Biopark by Sanofi SAS", now "Campus Curie Toulouse", making Evotec the full owner of the Toulouse (France) site
Continued expansion of infrastructure to support future growth in Abingdon (UK) and Göttingen (GER)
Mubadala Investment Company becomes strategic shareholder and Novo Holdings A/S reinforces its commitment, together investing € 250 m through a capital increase (after period-end)
Renewal of contract with CEO Dr Werner Lanthaler for five years until 05 March 2026 (after period-end)

GUIDANCE FOR FULL-YEAR 2020 CONFIRMED
Unchanged business outlook compared to half-year report 2020, taking into account currently visible COVID-19 effects
Group revenues from contracts with customers expected to range from € 440 – 480 m (2019: € 446.4 m)
"Unpartnered Group R&D" expenses of approx. € 45 m (2019: € 37.5 m)
Adjusted Group EBITDA expected to be in the range of € 100 – 120 m (2019: € 123.1 m)

Detailed information and financial tables are available in our nine months quarterly statement published on the Evotec website under the following link: View Source

Webcast/Conference Call
The Company is going to hold a conference call to discuss the results of the first nine months 2020 as well as to provide an update on its performance in the reporting period. The conference call will be held in English.

Webcast details

To join the audio webcast and to access the presentation slides you will find a link on our homepage shortly before the event.

A replay of the conference call will be available for seven days and can be accessed from Germany by dialling +49 69 201744221, from UK by dialling +44 20 3364 5150 and from USA by dialling +1 (844) 307-9362.

The access code is 315597280#. The on-demand version of the webcast will be available on our website: View Source

On November 11, 2020 Epizyme, (Nasdaq: EPZM), a fully integrated, commercial-stage biopharmaceutical company developing and delivering novel epigenetic therapies, reported that Robert Bazemore, president and chief executive officer, will participate in a fireside chat during the Jefferies Virtual London Healthcare Conference on Thursday, Nov. 18, 2020 at 12:35 p.m. ET (Press release, Epizyme, NOV 11, 2020, View Source [SID1234570678]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

A live webcast of the fireside chat will be available in the investor section of the company’s website and will be archived for 60 days following the presentation.

On November 11, 2020 Repare Therapeutics Inc. ("Repare" or the "Company") (Nasdaq: RPTX), a leading clinical-stage precision oncology company enabled by its proprietary synthetic lethality approach to the discovery and development of novel therapeutics, reported financial results for the third quarter ended September 30, 2020, as well as recent business highlights (Press release, Repare Therapeutics, NOV 11, 2020, View Source [SID1234570677]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"Since the closing of our IPO in June, we have made substantial and consistent progress to advance the development of our lead RP-3500 program, entering the clinic in July following the opening of a Phase 1/2 US IND for use as a monotherapy and in combination with talazoparib, all in patients with solid tumors," said Lloyd M. Segal, President and Chief Executive Officer of Repare. "We also expect to initiate a Phase 1 clinical trial for RP-6306 in the third quarter of 2021, ahead of our previously conveyed timeline where we anticipated an IND filing in the second half of 2021. We believe that our work in advancing a first-in-class product candidate into the clinic further validates our progress in identifying new synthetic lethal pairs and developing potent and selective inhibitors."

Third Quarter 2020 Review and Operational Updates:

Advanced CCNE-1 synthetic lethal inhibitor (now designated RP-6306) program into Good Laboratory Practice (GLP) toxicology studies ahead of original timeline. The Company anticipates initiating a Phase 1 clinical trial for RP-6306 in the third quarter of 2021, which is ahead of its original guidance of an IND filing in the second half of 2021.
Initiated a Phase 1/2 clinical trial evaluating RP-3500 as a monotherapy and in combination with Pfizer’s PARP inhibitor, talazoparib, in patients with solid tumors. In July 2020, the Company began dosing in a Phase 1/2 clinical trial of RP-3500, a potent and selective oral small molecule inhibitor of ATR (Ataxia-Telangiectasia and Rad3-related protein kinase) for the treatment of solid tumors in patients with specific genome instability-related genetic alterations, including those in the ATM gene (ataxia telangiectasia mutated kinase). RP-3500 will be evaluated as a monotherapy and in combination with Pfizer’s PARP inhibitor, talazoparib. Topline results are expected to be reported in the second half of 2021.
Inaugurated a newly expanded laboratory and office facility in Montreal, Quebec. In September 2020, the Company materially expanded its research footprint with the addition of 17,000 square feet of combined laboratory and office space in a newly built facility. The new facility more than doubled the Company’s laboratory capacity for its CRISPR-enabled genome-wide synthetic lethal target platform, SNIPRx, including dedicated space for work related to accelerating all of Repare’s preclinical assets, including those under its research collaboration with Bristol Myers Squibb.
Appointed new executive officer. In October 2020, Repare appointed Dr. Laurence F. Akiyoshi as its Executive Vice-President, Organizational and Leadership Development. Dr. Akiyoshi has joined Repare’s executive team after having served as an independent consultant to the Company for the past two years. In addition to his work with Repare, Dr. Akiyoshi has operated a private organizational development consulting practice that has advised numerous companies on scaling their organizations to support rapid growth. His clients have included leadership teams at Apple, LinkedIn, CrowdStrike and Box. Dr. Akiyoshi will be principally focused on organization design, leadership development, and attracting and retaining key team members necessary for Repare’s achievement of its corporate objectives.
Third Quarter 2020 Financial Results:

Cash and restricted cash: Cash and restricted cash as of September 30, 2020 were $348.1 million.
Research and development expenses, net of tax credits (Net R&D): Net R&D expenses were $10.1 million and $27.7 million for the three and nine month periods ended September 30, 2020, respectively, as compared to $5.6 million and $14.2 million in the same periods in the prior year, respectively. Increases in R&D for the three and nine month periods ended September 30, 2020 were primarily due to increases in development costs related to Repare’s RP-3500 and RP-6306 programs, as well as increases in personnel-related expenses and certain other R&D expenses.
General and administrative (G&A) expenses: G&A expenses were $4.0 million and $9.6 million for the three and nine month periods ended September 30, 2020, respectively, as compared to $1.3 million and $3.4 million in the same periods in the prior year, respectively. Increases in G&A for the three and nine month periods ended September 30, 2020 were due to increases in payroll and personnel costs as well as increases in legal, professional and D&O insurance costs in connection with preparations for becoming and now operating as a public company.
Net loss: Net loss was $13.8 million, or $0.37 per share in the third quarter of 2020 and $38.2 million, or $2.63 per share, in the first nine months of 2020.
About Repare Therapeutics’ SNIPRx Platform

Repare’s SNIPRx platform is a genome-wide CRISPR-based screening approach that utilizes proprietary isogenic cell lines to identify novel and known synthetic lethal gene pairs and the corresponding patients who are most likely to benefit from the Company’s therapies based on the genetic profile of their tumors. Repare’s platform enables the development of precision therapeutics in patients whose tumors contain one or more genomic alterations identified by SNIPRx screening, in order to selectively target those patients most likely to achieve clinical benefit from resulting product candidates.

On November 11, 2020 The US Oncology Network (The Network) reported that reached a major milestone recently in its journey to provide high-quality, value-based care to local communities by enrolling its 100,000th patient in the Centers for Medicare & Medicaid Innovation’s (CMMI) Oncology Care Model (OCM) (Press release, US Oncology, NOV 11, 2020, View Source [SID1234570676]). In realizing this goal, the participating Network practices delivered more than $122 million in cumulative savings to Medicare over the program’s first six performance periods (PP). The OCM is a five-year pilot program developed by CMMI to provide higher quality, more coordinated cancer care at the same or lower cost to Medicare. The program is part of Medicare’s ongoing effort to move healthcare to a system based on value rather than volume.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"We are very excited to enroll our 100,000th patient in the Oncology Care Model while also providing over $100 million in cumulative savings to Medicare," said Michael Seiden, MD, PhD, president, The US Oncology Network. "These achievements showcase the ability of practices in The Network to consistently perform well in the OCM while demonstrating that high-quality care and cost management can work in tandem to provide value to all stakeholders."

The OCM is a very large, complex program that requires enhanced patient care, effective cost management and comprehensive clinical data reporting to Medicare, to highlight only a few key elements of the program. Practices across The Network are performing well in the OCM, and most have shown improvement for each subsequent performance period.

"Celebrating our 100,000th OCM patient and seeing better performance each period remind us that success is an ongoing process," said Beatrice Mautner, vice president of Clinical & Innovent Services, The US Oncology Network. "We are continually striving to be at the forefront of value-based care by constantly developing innovative resources and solutions to challenges as they arise, empowering community oncology to lead the way forward and succeed in this new environment."

At the end of the most recent OCM performance period, PP6, significant gains occurred in critical performance areas across the participating Network practices, resulting in:

Improved quality compared to baseline performance during Performance Period 1
Hospitalizations reduced by 7 percent
Emergency department visits decreased by 3 percent
Hospice utilization increased by 5 percent
Increased focus on pain and depression management
The pain level of 94 percent of patients was captured and a plan implemented for elevated pain control
80 percent of patients who reported depression were screened and given strategies for improvement
Enhanced patient experience and services
Shared decision making with patients became a priority at the start of treatment
Patients received a comprehensive treatment plan explained by the physician
Access to care was improved with "Call Us First" campaigns, proactive high-risk outreach, enhanced triage, electronic patient-reported outcomes and same day/next morning urgent care access
Increased support and care coordination were provided through highly trained navigators and social workers
"The impressive results achieved by The Network is a testament to the commitment by the practices to deliver high-quality, value-based care," said Marcus Neubauer, MD, chief medical officer, The US Oncology Network. "Enrolling 100,000 patients into the OCM and earning high performance marks during PP6 are proof that the participating Network practices are major contributors to this program by providing quality care and saving healthcare dollars."

Although many practices participating in the OCM are still looking for a path to success, those in The Network have succeeded in part because they have access to comprehensive, proven resources that have helped them successfully transition to value-based care. These resources include industry-leading technologies that drive evidence-based decision-making at the point of care, advanced analytics for optimal data management and reporting, and innovative pharmacy solutions for efficient drug management. The Network, supported by McKesson, also provides practices access to thought leaders and key staff who have deep expertise in the OCM and value-based care.

"At least 50 percent of The Network practices participating in the OCM have chosen two-sided risk for 2020," noted Stuart Staggs, senior director of Strategic Programs, McKesson. "This demonstrates a very high level of confidence in the support they are receiving from The Network and McKesson that enables them to successfully meet the complex challenges the OCM presents."

The US Oncology Network is committed to ensuring community practices have access to all the resources necessary to successfully accomplish the massive practice transformation required by value-based and alternative payment models. To learn more, visit usoncology.com.