On September 4, 2019 Amgen (NASDAQ:AMGN) reported that it will host a webcast call for the investment community at the International Association for the Study of Lung Cancer (IASLC) 2019 World Conference on Lung Cancer (WCLC) on Sunday, Sept. 8, at 8 a.m. PT. David M. Reese, M.D., executive vice president of Research and Development at Amgen, along with members of Amgen’s clinical development team, will participate to discuss Amgen’s oncology program, including data being presented at WCLC for the Company’s KRASG12C inhibitor AMG 510 (Press release, Amgen, SEP 4, 2019, View Source [SID1234539284]).

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Live audio of the investor call will be broadcast over the internet simultaneously and will be available to members of the news media, investors and the general public.

The webcast, as with other selected presentations regarding developments in Amgen’s business given at certain investor and medical conferences, can be accessed on Amgen’s website, www.amgen.com, under Investors. Information regarding presentation times, webcast availability and webcast links are noted on Amgen’s Investor Relations Events Calendar. The webcast will be archived and available for replay for at least 90 days after the event.

On September 4, 2019 Adastra Pharmaceuticals, Inc., a biopharmaceutical company focused on the development of proprietary medicines for the treatment of cancer, reported that Scott Megaffin, Chief Executive Officer, will present at the 2019 Janney Healthcare Conference being held September 9-10, 2019, at The Union League Club in New York City (Press release, Adastra Pharmaceuticals, SEP 4, 2019, View Source [SID1234539283]).

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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

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Mr. Megaffin will present Adastra’s corporate growth strategy and clinical plans for its lead candidate, Zotiraciclib, which is designed to treat cancers characterized by Myc overexpression. Adastra is currently evaluating Zotiraciclib in two Phase 1b trials in glioblastoma multiforme (GBM) and a separate Phase 1b study in pediatric diffuse intrinsic pontine glioma (DIPG).

Event:

2019 Janney Healthcare Conference

Date:

Monday, September 9, 2019

Time:

11:50 AM (Eastern Time)

Location:

The Union League Club, New York, NY

Webcast Link:

View Source;eom

The presentation’s audio and slides will be webcast live and available for up to 90 days via the webcast link above and on Adastra’s website at www.adastrarx.com.

On September 4, 2019 Dendreon Pharmaceuticals, a commercial-stage biopharmaceutical company and pioneer in the development of immunotherapy, reported publication of results from its PROCEED registry, which evaluated real-world use of PROVENGE (sipuleucel-T) in men with asymptomatic or minimally symptomatic metastatic castrate-resistant prostate cancer (mCRPC) (Press release, Dendreon, SEP 4, 2019, View Source [SID1234539280]). The findings, published in Cancer1, showed that men with mCRPC who were treated with PROVENGE when their PSA was <5.27 ng/mL had a median survival of nearly four years.

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"The median survival of four years following treatment with PROVENGE is meaningful," said Celestia S. Higano, M.D., FACP, lead author of the PROCEED analysis, and professor, Division of Medical Oncology, Department of Medicine, University of Washington School of Medicine and Fred Hutchinson Cancer Research Center. "PROCEED provides a real-world portrait of the expected OS after sipuleucel-T in mCRPC patients in the modern era of five additional life-prolonging agents."

Notably, 44% of patients with a PSA of <5.27 ng/mL did not receive any additional cancer treatments for at least one year. Of those, 95% were treated with PROVENGE as first-line therapy for mCRPC as recommended by the National Comprehensive Cancer Network (NCCN).

"Median baseline PSA levels at mCRPC diagnosis have declined steadily since the approval of PROVENGE in 2010," said Bruce A. Brown, M.D., chief medical officer at Dendreon. "Of the nearly 2,000 patients enrolled in PROCEED between 2011-2014 a quarter had a PSA of <5.27 ng/mL, and these men lived much longer than those in the higher quartiles. It’s worth noting that the median baseline PSA levels observed in PROCEED are lower than those in the pivotal IMPACT trial and would likely be lower if PROCEED was enrolling today."

PROCEED Registry – Baseline PSA and Median Survival

<5.27 ng/mL – 47.7 months
>5.27 to ≤15.08 ng/mL – 33.2 months
>15.08 to ≤ 46 ng/mL – 27.2 months
>46 ng/mL – 18.4 months
Findings from the PROCEED registry are consistent with a previous post-hoc analysis of the pivotal Phase 3 IMPACT trial of sipuleucel-T published in Urology in 2013. In that analysis, a lower baseline PSA level was associated with improved overall survival (OS). Among patients with a baseline PSA ≤22.1 ng/mL, the median OS was 41.3 months (3.4 years) for those treated with sipuleucel-T vs. 28.3 months for those in the control arm – an improvement of 13 months.2

About the PROCEED Registry

PROCEED (NCT01306890) was a multicenter, open-label, observational registry conducted at urology and medical oncology clinics in private practice and academic sites. PROCEED enrolled 1,976 patients with mCRPC who received PROVENGE between 2011 and 2014 in everyday treatment settings. Patients were followed for a median of 46.6 months. Their median age was 72 years and their median baseline PSA was 15.0 ng/mL.

About PROVENGE (sipuleucel-T)

PROVENGE is the only FDA-approved immunotherapy made from a patient’s own immune cells for the treatment of prostate cancer. More than 30,000 men have been prescribed PROVENGE, and it has been clinically proven to extend life for certain men in advanced stages of the disease.

INDICATION

PROVENGE is an autologous cellular immunotherapy indicated for the treatment of asymptomatic or minimally symptomatic metastatic castrate-resistant (hormone-refractory) prostate cancer.

IMPORTANT SAFETY INFORMATION

Acute Infusion Reactions: Acute infusion reactions (reported within 1 day of infusion) may occur and include nausea, vomiting, fatigue, fever, rigor or chills, respiratory events (dyspnea, hypoxia, and bronchospasm), syncope, hypotension, hypertension, and tachycardia.

Thromboembolic Events: Thromboembolic events, including deep venous thrombosis and pulmonary embolism, can occur following infusion of PROVENGE. The clinical significance and causal relationship are uncertain. Most patients had multiple risk factors for these events. PROVENGE should be used with caution in patients with risk factors for thromboembolic events.

Vascular Disorders: Cerebrovascular events (hemorrhagic/ischemic strokes and transient ischemic attacks) and cardiovascular disorders (myocardial infarctions) have been reported following infusion of PROVENGE. The clinical significance and causal relationship are uncertain. Most patients had multiple risk factors for these events.

Handling Precautions: PROVENGE is not tested for transmissible infectious diseases.

Concomitant Chemotherapy or Immunosuppressive Therapy: Chemotherapy or immunosuppressive agents (such as systemic corticosteroids) given concurrently with the leukapheresis procedure or PROVENGE has not been studied. Concurrent use of immune-suppressive agents may alter the efficacy and/or safety of PROVENGE.

Adverse Reactions: The most common adverse reactions reported in clinical trials (≥ 15% of patients receiving PROVENGE) were chills, fatigue, fever, back pain, nausea, joint ache, and headache.

For full Prescribing Information, please visit www.dendreon.com/Products.

On September 4, 2019 NANOBIOTIX (Paris:NANO) (Euronext: NANO – ISIN: FR0011341205 – the "Company"), a late clinical-stage nanomedicine company pioneering new approaches to the treatment of cancer, reported its half year financial results for the six-month period ended June 30, 2019 (Press release, Nanobiotix, SEP 4, 2019, View Source [SID1234539279]). These results are represented in the consolidated financial statements at 30 June, 2019 that were reviewed by the Supervisory Board and the Executive Board dated September 4, 2019 and have been subject to a limited review by the Company’s statutory auditors.

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Philippe Mauberna, CFO of Nanobiotix, commented: "The first half of 2019 was marked by a major event with the CE marking of first-in-class radioenhancer NBTXR3, under the brand name Hensify. The clinical registration plan for head and neck cancers in the United States, communicated in March, is also a big step forward for our company. The strength of our cash position gives us financial visibility to carry out our development plans through Q4 2020."

Financial Highlights

Revenue for the first half of 2019 amounted to €1.8m (H1 2018: €2.1m), coming mainly from €1.8m of Research Tax Credit
In April 2019, the Company raised €29.5m in a placement of new shares to a specific class of investors
Given the expected expansion and acceleration of the Company’s global development strategy, operating expenses grew significantly compared to the previous year (€22.3m in H1 2019 vs. €15.0m in H1 2018)
The operating result for the period was a €20.5m loss compared to €13.0m (loss) in H1 2018
The Company had cash and financial investments at June 30, 2019 of €55.1m (31 December 2018: €36.2m)
Operational Highlights

In January 2019, clinical development continued to progress as Nanobiotix announced it partnered with The University of Texas MD Anderson Cancer Center to launch a large-scale, comprehensive clinical collaboration for first-in-class radioenhancer NBTXR3. The collaboration will initially support nine new phase I/II clinical trials evaluating NBTXR3 in the treatment of six cancer types and will involve around 340 patients.

At the end of March 2019, Nanobiotix also announced its clinical registration plan for head and neck cancers in the United States, following US Food and Drug Administration (FDA) feedback. The Company plans to initiate its global clinical trial authorization process with FDA in Q4 2019.

In early April 2019, the Company posted that first-in-class radioenhancer NBTXR3, under the brand name Hensify, obtained first European market approval for the treatment of locally advanced Soft Tissue Sarcoma (STS) of the extremity or trunk wall.

During that six-month period, the Company also announced the presentation of pre-clinical data showing that the combination of NBTXR3, radiotherapy and anti-PD-1 immunotherapy demonstrated efficacy in treating resistant pre-clinical in vivo lung cancer.

On the financial front, Nanobiotix received €14m in March through the second tranche disbursement of loan financing from the European Investment Bank (EIB). The Company also raised approximately €29.5m in April 2019 through the placement of new shares to a specific class of investors. The proceeds of this recent offering will primarily be used to prepare for the launch of the expected phase II/III clinical trial in head and neck cancers for registration in the United-States.

As a result of this latest transaction, the Company’s cash visibility now extends through the end of 2020. In late April, CEO Laurent Levy also subscribed to new shares in the Company, exercising founders’ warrants (Bons de Souscription de Parts de Créateur d’Entreprise or "BSPCE") for an amount of €960,000.

Subsequent Events

Nanobiotix also recently announced organizational changes as the Company enters its next stage following its first European market approval.

In May, Nanobiotix also announced the launch of Curadim, a new nanotechnology platform for healthcare.

Financial Review (IFRS)

Statement of profit and loss and other comprehensive income

* At June 30, 2018, the information disclosed included R&D costs of €8,571k and SG&A costs of €5,330k. As explained in the notes to the consolidated financial statements, comparative information as of June 30, 2018 as presented in the June 30, 2019 accounts includes the reclass in R&D and SG&A of share-based payment charges of €266k and €870k respectively, as well as the reclass of other operating costs in R&D amounting to €3k.

Total revenue for H1 2019 amounted to €1.8m (H1 2018: €2.1m) including:

The recharge of costs related to activities planned from partnerships with PharmaEngine for €37k
Other revenues of €1.8m mostly coming from the Research Tax Credit (CIR) for €1.8m, in line with the same period last year
Operating expenses for the six-month period ended June 30, 2019 were €22.3m (H1 2018: €15.0m), divided as follows:

R&D expenses including share-based payment expenses, were €13.4m—an increase of €5.4m compared to the same period last year (H1 2018: €8.8m) reflecting increased activity related to on-going clinical programs as well as the new organization post European market approval for Hensify (NBTXR3) in STS of the extremity or trunk wall
SG&A expenses including share-based payment expenses increased by €2.7m to €8.9m (H1 2018: €6.2m), in line with the overall increase in activities in R&D.
The Company’s operating loss for the period was €20.5m (H1 2018: €13.0m loss) and the total comprehensive loss was €23.9m (H1 2018: €12.7m loss).

The Company’s cash availability as of June 30, 2019 amounted to €54.9m (Dec. 31, 2018: €36.2m).

At June 30, 2019, the Company’s debt amounted €44.1m corresponding to €33.3m from the EIB, €7.0m relating to the new lease liability, €2.1m refundable advance and €1.6m of BPI loan.

The Company’s total headcount was 111 employees as of June 30, 2019 (74% in R&D) compared to 102 at December 31, 2018.

The half year financial report has been subject to a limited review by Nanobiotix’ statutory auditors. The consolidated financial statements as at and for the six months to June 30, 2019 were prepared in accordance with IAS 34. Such documents are available on the Company’s website at www.nanobiotix.com

-ends-

Next financial press release: Revenue for Q3 2019 on October 25, 2019

On September 4, 2019 PharmaCyte Biotech, Inc. (OTCQB: PMCB), a biotechnology company focused on developing targeted cellular therapies for cancer and diabetes using its signature live-cell encapsulation technology, Cell-in-a-Box, reported that it has released a new video documentary of its pancreatic cancer therapy (Press release, PharmaCyte Biotech, SEP 4, 2019, View Source [SID1234539278]). The video, which was written and produced by Stock Market Media Group, uses storytelling to introduce the viewer to this hard-to-treat disease, the current options available for pancreatic cancer patients and then presents PharmaCyte’s leading product candidate – locally advanced pancreatic cancer (LAPC) – in full detail.

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The video is available on PharmaCyte’s website at: View Source

PharmaCyte’s Chief Executive Officer, Kenneth L. Waggoner, stated, "We are excited to see the story of our pancreatic cancer therapy unfold in this video documentary. Stock Market Media Group spent a week with us in Thailand and took the time to carefully understand our story, where we are currently in our clinical trial development plan and then briefly discusses the future ahead for PharmaCyte. Stock Market Media has clearly documented our story in the pancreatic cancer area and has carefully explained the emotional impact of this terrible disease. We think this video will offer PharmaCyte a real opportunity to explain to the world what we are attempting to do with our leading product candidate and why."