On September 4, 2020 Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), reported that the U.S. Food and Drug Administration (FDA) has approved Gavreto (pralsetinib) for the treatment of adults with metastatic rearranged during transfection (RET) fusion-positive non-small cell lung cancer (NSCLC) as detected by an FDA approved test (Press release, Genentech, SEP 4, 2020, View Source [SID1234564506]). This indication was approved under the FDA’s accelerated approval program based on data from the Phase I/II ARROW study. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. Gavreto is a once-daily, oral precision therapy designed to selectively target RET alterations, including fusions and mutations.

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"We remain committed to finding personalized treatment options for people with cancer based on specific genomic or molecular alterations, and we look forward to partnering with Blueprint Medicines to further explore the potential of Gavreto across multiple RET-altered tumor types."

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"The FDA approval of Gavreto for RET fusion-positive non-small cell lung cancer is an important step towards our goal of providing an effective treatment option for every person diagnosed with lung cancer, no matter how rare or hard-to-treat their type of disease," said Levi Garraway, M.D., Ph.D., chief medical officer and head of Global Product Development. "We remain committed to finding personalized treatment options for people with cancer based on specific genomic or molecular alterations, and we look forward to partnering with Blueprint Medicines to further explore the potential of Gavreto across multiple RET-altered tumor types."

RET-activating fusions and mutations are key disease drivers in many cancer types, including NSCLC and medullary thyroid cancer (MTC), and treatment options that selectively target these genetic alterations are limited. In NSCLC, RET fusions represent approximately 1-2% of patients. Biomarker testing for these fusions is the most effective way to identify people who are eligible for treatment with Gavreto.

The approval is based on the results from the Phase I/II ARROW study, in which Gavreto produced durable clinical responses in people with RET fusion-positive NSCLC with or without prior therapy, and regardless of RET fusion partner or central nervous system involvement. Gavreto demonstrated an overall response rate (ORR) of 57% (95% CI: 46%, 68%) and complete response (CR) rate of 5.7% in the 87 people with NSCLC previously treated with platinum-based chemotherapy, and the median duration of response (DoR) was not reached (95% CI: 15.2 months, not reached). In the 27 people with treatment-naïve NSCLC, the ORR was 70% (95% CI: 50%, 86%) with an 11% CR rate. The most common adverse reactions (≥25%) were fatigue, constipation, musculoskeletal pain and increased blood pressure (hypertension).

Gavreto is now the sixth FDA-approved medicine in Genentech’s portfolio of treatments for lung cancer. The FDA granted Breakthrough Therapy Designation to Gavreto for the treatment of RET fusion-positive NSCLC that has progressed following platinum-based chemotherapy and for RET mutation-positive MTC that requires systemic treatment and for which there are no acceptable alternative treatments.

The FDA has also granted Priority Review to Gavreto for the treatment of people with advanced or metastatic RET-mutant MTC and RET fusion-positive thyroid cancer, and is expected to make a decision on approval by February 28, 2021. This New Drug Application (NDA) was accepted for review under the FDA’s Real-Time Oncology Review (RTOR) pilot program, which aims to explore a more efficient review process to ensure safe and effective treatments are available to patients as early as possible.

For those who qualify, Blueprint Medicines will offer patient assistance programs for people prescribed Gavreto by their doctor through YourBlueprint . Please visit www.yourblueprint.com or contact 1-888-BLUPRNT for more information.

About the ARROW study

ARROW (NCT03037385) is a Phase I/II, open-label, first-in-human study designed to evaluate the safety, tolerability and efficacy of Gavreto, administered orally in people with rearranged during transfection (RET) fusion-positive non-small cell lung cancer (NSCLC), RET-mutant medullary thyroid cancer (MTC), RET fusion-positive thyroid cancer and other RET-altered solid tumors. The trial consists of two parts: a dose escalation portion, which is complete, and an expansion portion in people treated with 400 mg of Gavreto, once-daily. ARROW is being conducted at multiple sites across the United States, European Union and Asia.

About lung cancer

According to the American Cancer Society, it is estimated that more than 228,000 Americans will be diagnosed with lung cancer in 2020, and NSCLC accounts for 80-85% of all lung cancers. It is estimated that approximately 85% of lung cancer diagnoses in the United States are made when the disease is in the advanced stages. In NSCLC, RET fusions represent approximately 1-2% of patients.

About Gavreto

Gavreto is a once-daily, oral precision therapy designed to selectively target RET alterations, including fusions and mutations, regardless of the tissue of origin. Preclinical data have shown that Gavreto inhibits primary RET fusions and mutations that cause cancer in subsets of patients, as well as secondary RET mutations predicted to drive resistance to treatment. Blueprint Medicines and Genentech are also co-developing Gavreto for the treatment of patients with various types of RET-altered thyroid cancers and other solid tumors.

Gavreto U.S. Indication

Gavreto (pralsetinib) is indicated for the treatment of adult patients with metastatic rearranged during transfection (RET) fusion-positive non-small cell lung cancer (NSCLC) as detected by an FDA approved test.

This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

Important Safety Information

Gavreto may cause serious side effects, including:

Lung problems (pneumonitis) occurred in 10% of patients who received Gavreto, including 2.7% with Grade 3/4, and 0.5% with fatal reactions. Monitor for pulmonary symptoms indicative of interstitial lung disease (ILD)/pneumonitis. Withhold Gavreto and promptly investigate for ILD in any patient who presents with acute or worsening of respiratory symptoms (e.g., dyspnea, cough, and fever). Withhold, reduce dose or permanently discontinue Gavreto based on severity of confirmed ILD.

Increased blood pressure (hypertension) occurred in 29% of patients, including Grade 3 hypertension in 14% of patients. Overall, 7% had their dose interrupted and 3.2% had their dose reduced for hypertension. Treatment-emergent hypertension was most commonly managed with anti-hypertension medications. Do not initiate Gavreto in patients with uncontrolled hypertension. Optimize blood pressure prior to initiating Gavreto. Monitor blood pressure after 1 week, at least monthly thereafter and as clinically indicated. Initiate or adjust anti-hypertensive therapy as appropriate. Withhold, reduce dose, or permanently discontinue Gavreto based on the severity.

Liver problems (hepatotoxicity): Serious hepatic adverse reactions occurred in 2.1% of patients treated with Gavreto. Increased AST occurred in 69% of patients, including Grade 3/4 in 5.4% and increased ALT occurred in 46% of patients, including Grade 3/4 in 6%. The median time to first onset for increased AST was 15 days (range: 5 days to 1.5 years) and increased ALT was 22 days (range: 7 days to 1.7 years). Monitor AST and ALT prior to initiating Gavreto, every 2 weeks during the first 3 months, then monthly thereafter and as clinically indicated. Withhold, reduce dose or permanently discontinue Gavreto based on severity.

Grade ≥3 bleeding (hemorrhagic events) occurred in 2.5% of patients treated with Gavreto including one patient with a fatal hemorrhagic event. Permanently discontinue Gavreto in patients with severe or life-threatening hemorrhage.

Impaired wound healing can occur in patients who receive drugs that inhibit the vascular endothelial growth factor (VEGF) signaling pathway. Therefore, Gavreto has the potential to adversely affect wound healing. Withhold Gavreto for at least 5 days prior to elective surgery. Do not administer for at least 2 weeks following major surgery and until adequate wound healing. The safety of resumption of Gavreto after resolution of wound healing complications has not been established.

Based on findings from animal studies and its mechanism of action, Gavreto can cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective non-hormonal contraception during treatment with Gavreto and for 2 weeks after the final dose. Advise males with female partners of reproductive potential to use effective contraception during treatment with Gavreto and for 1 week after the final dose. Advise women not to breastfeed during treatment with Gavreto and for 1 week after the final dose.

Common adverse reactions (≥25%) were fatigue, constipation, musculoskeletal pain, and hypertension. Common Grade 3-4 laboratory abnormalities (≥2%) were decreased lymphocytes, decreased neutrophils, decreased phosphate, decreased hemoglobin, decreased sodium, decreased calcium (corrected) and increased alanine aminotransferase (ALT).

Avoid coadministration with strong CYP3A inhibitors. Avoid coadministration of Gavreto with combined P-gp and strong CYP3A inhibitors. If coadministration cannot be avoided, reduce the Gavreto dose. Avoid coadministration of Gavreto with strong CYP3A inducers. If coadministration cannot be avoided, increase the Gavreto dose.

Please click here to see the full Prescribing Information for Gavreto.

Gavreto, Blueprint Medicines, YourBlueprint and associated logos are trademarks of Blueprint Medicines Corporation.

About Genentech in lung cancer

Lung cancer is a major area of focus and investment for Genentech, and we are committed to developing new approaches, medicines and tests that can help people with this deadly disease. Our goal is to provide an effective treatment option for every person diagnosed with lung cancer. We currently have six approved medicines to treat certain kinds of lung cancer and more than 10 medicines being developed to target the most common genetic drivers of lung cancer or to boost the immune system to combat the disease.

On September 4, 2020 Humanigen, Inc. (HGEN) ("Humanigen"), a clinical stage biopharmaceutical company focused on preventing and treating an immune hyper-response called ‘cytokine storm’ with lenzilumab, the company’s proprietary Humaneered anti-human granulocyte macrophage-colony stimulating factor (GM-CSF) monoclonal antibody, reported that its board of directors has determined to effect a 1-for-5 reverse split of its outstanding shares of common stock (Press release, Humanigen, SEP 4, 2020, View Source [SID1234564505]). The company had previously disclosed that, on July 29, 2020, holders of a majority of the company’s outstanding shares of common stock had consented to a possible reverse stock split and granted the board the authority to determine the exact split ratio, within a specified range, at any time prior to July 29, 2021.

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Subject to completion of all required regulatory reviews, the reverse stock split is expected to occur at 4:30 p.m. Eastern Time on September 11, 2020, with trading expected to begin on a split-adjusted basis on the OTCQB Venture Market at the market open on September 14, 2020. Trading in the common stock will continue under the symbol "HGEN" but the security will be assigned a new CUSIP number.

The reverse stock split is intended to enable the company to achieve several important corporate objectives, including enabling the company to satisfy the minimum bid price requirement in connection with the company’s application to list its common stock on the Nasdaq Capital Market and making additional shares of common stock available for future issuance.

When the reverse stock split becomes effective, every 5 shares of the company’s issued and outstanding common stock will be automatically combined into one issued and outstanding share of common stock without any change in the par value per share or the total number of authorized shares. This will reduce the number of outstanding shares of the company’s common stock from approximately 211 million shares to approximately 42 million shares.

No fractional shares will be issued in connection with the reverse stock split. Stockholders of record otherwise entitled to receive a fractional share as a result of the reverse stock split will receive a cash payment in lieu of such fractional shares. Stockholders of record holding shares in book-entry form will not need to take any action to receive post-reverse split shares. Stockholders of record holding some or all of their shares in certificate form will receive instructions from the company’s exchange agent, Computershare, as to how to exchange existing stock certificates for book-entry statements representing the post-reverse split shares. With respect to stockholders holding shares in "street name" (i.e., through a bank, broker, custodian or other nominee), banks, brokers, custodians, or other nominees will be instructed to effect the reverse stock split for their beneficial holders.

Following the approval of the reverse stock split, the Humanigen Board of Directors no longer expects to pursue the proposed amendment to the company’s charter to increase the number of authorized shares of common stock, which will remain at 225,000,000. In addition, the number of shares reserved for issuance pursuant to the Humanigen, Inc. 2020 Omnibus Incentive Compensation Plan, or the 2020 Plan, also approved by stockholders on July 29, 2020, will be reduced from 35,000,000 to 7,000,000 shares at the effective date of the reverse stock split.

Additional information regarding the reverse stock split and the 2020 Plan can be found in the company’s definitive information statement filed with the Securities and Exchange Commission on August 14, 2020, a copy of which is available at www.sec.gov.

On September 4, 2020 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, 2020 (Press release, Nanobiotix, SEP 4, 2020, View Source [SID1234564504]). These results are represented in the condensed consolidated financial statements as at 30 June, 2020, reviewed by the Supervisory Board and the Executive Board on September 4, 2020 and have been subjected to a limited review by the Company’s statutory auditors.

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Major milestones achieved during the half-year include:
Granted Fast Track designation by the United States Food and Drug Administration (US FDA) for the treatment of the patients with locally advanced head and neck cancer, ineligible for platinum-based chemotherapy
Announced positive new data from the phase I dose expansion in locally advanced head and neck cancer
Received ‘safe to proceed’ from the FDA for the first phase I trial evaluating NBTXR3 in pancreatic cancer
Secured non-dilutive financing of €10M in the form of State-Guaranteed Loans (Prêts Garantis par l’Etat, or PGE in France)
Consolidated cash availability of €26.6M as at June 30, 2020
"In the context of the COVID-19 crisis, the first half of 2020 presented a unique challenge for our business. This led the Company to rapidly adapt both its organization and operations to protect the interests of employees, partners, shareholders and, above all, the patient populations in need of improved treatment outcomes. Despite the circumstances, Nanobiotix’s overall development plan has progressed as expected and the priorities of the Company are steadfast as we continue to develop in head and neck cancer as well as Immuno-Oncology. The cash availability at the end of June 2020, boosted by the State-Guaranteed Loans, and further augmented by the capital raise announced in July 2020, will allow us to secure our growth well into mid-2022 with strong capabilities to deliver on our development plan." Philippe Mauberna, CFO of Nanobiotix.

Consolidated Income Statement (IFRS) :

30 June
2020

30 June
2019

K€

Revenues and other income

Operating revenues

37

37

Other income

1.411

1.786

Total revenues and other income

1.448

1.823

Research and Development expenses

(13.077)

(13.380)

Selling, general and administrative expenses

(6.755)

(8.910)

Total operating expenses

(19.832)

(22.290)

Operating income

(18.384)

(20.467)

Financial income

234

724

Financial expenses

(2.428)

(4.176)

Net financial income

(2.194)

(3.452)

Income tax

(1)

–

Net loss

(20.579)

(23.920)

Basic loss per share (euros)

(0.91)

(1.15)

Diluted loss per share (euros)

(0.91)

(1.15)

Financial Review

Total revenues for 1H 2020 amounted to €1.4M (1H 2019: €1.8M) including:

Revenue related to cross-charged services provided by the Company to its partner PharmaEngine, pursuant to a commercial agreement which amounted to €37K in 1H 2020 (1H 2019: €37K);
Other revenue of €1.4M in 1H 2020 (1H 2019: €1.8M), mainly related to the Research Tax Credit (Crédit d’Impôt Recherche – CIR).
Total operating expenses for 1H 2020 reached €19.8M (1H 2019: €22.3M):

R&D expenses (including share-based compensation expenses) amounted to €13.1M in 1H 2020 (1H 2019: €13.4M). Supporting R&D activities remains the priority of the Company;
Selling, general and administrative expenses (SG&A) (including share-based compensation expenses) were €6.8M (1H 2019: €8.9M).
The Company’s operating loss for the period was €18.3M (1H 2019: €20.5M) and the net loss for 1H 2020 was €20.6M (1H 2019: €23.9M).

Consolidated cash position as at June 30, 2020 amounted to €26.6M (December 31, 2019: €35.1M) whereby this cash position takes into account the receipt of the 2018 Research Tax Credit and the first part of the State-Guaranteed Loans of €5M (PGE from HSBC).

The Company believes that its cash and cash equivalents should ensure its business continuity for at least 12 months following the publication of the consolidated half-year financial statements as at June 30, 2020.

In July 2020, Nanobiotix announced receipt of the second part of the State-Guaranteed Loans amounting to €5M (PGE from Bpifrance) and the return of the 2019 Research Tax Credit. The Company also got the gross proceeds of a capital raise by issuing new shares amounting to €20M.

As at the end of June 2020, the Company’s total headcount was 98 FTEs (of which 73% is in R&D) compared to 111 at the end of June 2019.

Nanobiotix Activities and Achievements Year-to-Date 2020

Nanobiotix Clinical Updates

In January 2020, the Company announced its plans for a global phase III registration trial in head and neck cancer (Study 312), along with its overall development strategy for 2020 and beyond.

After establishing the proof-of-concept and first market approval for NBTXR3 in locally advanced soft tissue sarcoma of the extremities and trunk wall, Nanobiotix is now prioritizing the development of t in the United States and the European Union for the treatment of head and neck cancers. These indications have a high incidence, significant unmet medical needs, and offer a prime opportunity to demonstrate medical and economic value for NBTXR3. The Company is also moving forward with its evaluation of NBTXR3 as a potential pillar of Immuno-Oncology, given positive data showing that the product may generate an immune response in patients on its own, as well as increase the efficacy of immune checkpoint inhibitors in combination. In parallel, Nanobiotix and its collaborators will continue to develop NBTXR3 across several additional indications including lung, esophageal and pancreatic.

In February 2020, NBTXR3 received FDA Fast Track designation for the study of NBTXR3 activated by radiation therapy, with or without cetuximab, for the treatment of patients with locally advanced head and neck cancer who are not eligible for platinum-based chemotherapy. Fast Track is a process designed to facilitate the development and accelerate the review of drugs for serious conditions and that have the potential to address unmet medical needs. The purpose is to expedite the availability of new treatment options for patients.

In April 2020, the Company provided updates on clinical development continuity in the context of the COVID-19 crisis. Nanobiotix announced that the global development plan in head and neck cancer and Immuno-Oncology is moving forward and priorities remain unchanged with limited impact from the crisis.

In May 2020, the first results from the phase I expansion trial were presented at the U.S. congress, ASCO (Free ASCO Whitepaper) 2020. This study evaluates the potential of NBTXR3 to improve treatment outcomes for elderly patients with locally advanced head and neck cancer ineligible for chemotherapy or intolerant to cetuximab. NBTXR3 has been administered to 40 patients in the trial and was well tolerated, maintaining the safety profile observed in the dose escalation part of the phase I study. Analysis of 30 evaluable patients for efficacy showed a primary tumor objective response rate of 83%, including a complete response rate of 60% in the target lesion, which are the co-primary endpoints of the study. The preliminary safety and efficacy data further reinforce NBTXR3 as a potential new option for head and neck cancer patients.

The FDA provided feedback necessary to proceed with the design of Study 312, a pivotal phase III trial investigating NBTXR3 for elderly head and neck cancer patients ineligible for platinum-based chemotherapy. The FDA also agreed to the NBTXR3 chemistry, manufacturing and controls (CMC) development plan to support the future New Drug Application (NDA) for the product and its use in a phase III clinical trial.

Clinical Collaboration Updates

In May 2020, Nanobiotix announced that the first trial from its clinical collaboration with the University of Texas MD Anderson Cancer Center (MD Anderson) had been designated as "safe to proceed" by the FDA. The trial was co-developed by Nanobiotix with MD Anderson as the sponsor and executor. This trial is a phase I dose escalation study evaluating the safety and feasibility of NBTXR3 activated by radiation therapy in patients with locally advanced or borderline-resectable pancreatic ductal adenocarcinoma. It will recruit up to approximately 24 patients.

Curadigm Updates

In March 2020, Curadigm—a wholly-owned subsidiary of Nanobiotix with a dedicated team and proprietary technology—announced the selection of its Nanoprimer technology by the National Cancer Institute’s (NCI) lab for characterization and development collaboration. This collaboration will support the development of Nanoprimer, driving advancement toward an Investigational New Drug application (IND) and future clinical development. This work will also support ongoing and future collaborations combining Nanoprimer with therapeutics across various clinical indications.

In June 2020 at the virtual Annual Meeting of the American Association for Cancer Research (AACR) (Free AACR Whitepaper), Curadigm announced pre-clinical in vivo results demonstrating that its novel Nanoprimer technology could increase the efficacy of RNA-based therapeutics up to 50% by decreasing rapid liver clearance. These RNA-based therapeutics are a new, growing opportunity but are currently limited by inefficient intravenous delivery to target areas in the body.

Financial Events

In June 2020, Nanobiotix announced that it had received financing approval from HSBC and Bpifrance for a total of €10M in the form of State-Guaranteed Loans. In June 2020, the Company received the first half of the loan from HSBC and the second half from Bpifrance was received in July 2020.

In July 2020, Nanobiotix launched a capital increase by means of an accelerated bookbuild offering. The Company successfully raised approximately €20M in gross proceeds with US and EU specialized biotech investors including Perceptive Advisors LLC and Invus Public Equities LLP, other new investors and existing shareholders. The net proceeds from the reserved offering will serve to prepare and initiate its lead program in head and neck cancers with the start of the global phase III trial.

Additionally, Curadigm announced the receipt of €1M in non-dilutive funding from Deep Tech Bpifrance for the development of its Nanoprimer technology. This program recognizes biotechnology companies with breakthrough innovation and strong commercial potential.

On September 4, 2020 BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160), a commercial-stage biotechnology company focused on developing and commercializing innovative medicines worldwide, reported that the company’s ordinary shares, which trade on the Hong Kong Stock Exchange, will be included in the Shanghai-Hong Kong Stock Connect and Shenzhen-Hong Kong Stock Connect programs, effective on September 7, 2020 (Press release, BeiGene, SEP 4, 2020, View Source [SID1234564503]). In addition, BeiGene’s ordinary shares will be included in Hang Seng Composite Index (HSCI).

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"We are excited to be included in the Stock Connect programs and the HSCI, as one of the first biotech companies listed in Hong Kong and the first biotech company with dual primary listings on NASDAQ and the Hong Kong Stock Exchange," commented John V. Oyler, Chairman, Co-Founder and Chief Executive Officer of BeiGene. "We expect that the inclusion in the Stock Connects and the HSCI can allow us to access a broader investor base in mainland China."

About the Stock Connect Programs

The Stock Connect programs are a unique collaboration between the Hong Kong, Shanghai and Shenzhen stock exchanges. The Stock Connects allow international and mainland Chinese investors to trade securities in each other’s markets through the trading and clearing facilities of the participating exchanges. The Stock Connects established a two-way trading link between stock exchanges in mainland China and Hong Kong. The Stock Connects allow qualified mainland China investors to access eligible Hong Kong shares (Southbound) as well as Hong Kong and overseas investors to trade eligible A shares (Northbound), subject to specified daily quotas.

On September 4, 2020 Novocure (NASDAQ: NVCR) reported that William Doyle, the company’s Executive Chairman, and Dr. Uri Weinberg, the company’s Chief Science Officer, will participate in the 2020 Wells Fargo Virtual Healthcare Conference on September 9, 2020 (Press release, NovoCure, SEP 4, 2020, View Source [SID1234564502]). Mr. Doyle and Dr. Weinberg will take part in a fireside chat at 8:40 a.m. EDT. Mr. Doyle and Dr. Weinberg will also participate in one-on-one meetings with investors throughout the day.

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A live webcast of the presentation can be accessed from the Investor Relations page of Novocure’s website, www.novocure.com/investor-relations, and will be available for replay for at least 14 days following the event.

Novocure’s corporate presentation is updated periodically, and the current presentation can be accessed from the Investor Relations page of Novocure’s website, www.novocure.com/investor-relations. Novocure has used, and intends to continue to use, its investor relations website as a means of disclosing material non-public information and for complying with its disclosure obligations under Regulation FD.