IntraOp® Announces First Patient Enrolled in Cosmopolitan Trial for Breast Cancer

On April 22, 2020 IntraOp Medical Corporation reported the first patient enrolled in the Cosmopolitan Trial: A randomized study of single treatment electron-beam intraoperative radiation therapy (IORT) delivered during surgery compared to external beam radiation therapy which is delivered over 3-4 weeks (Press release, IntraOp Medical, APR 22, 2020, View Source [SID1234556510]).

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Breast cancer is the most frequent malignancy in women. For every 8 women, 1 will be inflicted with breast cancer during her lifetime. Many women suffer from side-effects related to their treatment. One of the most common side-effects of radiotherapy is fatigue, which, for 40% of patients, persists long after completing their treatment. Further, with rising healthcare costs, researchers are continuously investigating methods to de-escalate treatment not only to improve clinical results for their patients but also to reduce the socio-economic burden for such care.

Electron-beam IORT, which replaces 15 to 30 treatments of traditional radiotherapy, is the ultimate form of de-escalation for low risk breast cancer. Electron IORT may be particularly beneficial for patients who have an active lifestyle or travel long distances to receive their postoperative care. Fewer hospital visits not only reduces the burden on patients and their family but also hospital staff and resources—a topic at the forefront for all healthcare executives and government officials in the wake of the current COVID-19 pandemic.

The Cosmopolitan Trial is a multi-center trial led by Principal Investigator Prof. Jürgen Debus of Heidelberg University in Germany. The primary objective of the study is to demonstrate that electron IORT significantly increases the quality of life for patients; thereby reducing the socioeconomic burden for providing high quality care.

"Breast cancer remains one of the most common cancers inflicting women. The clinical evidence indicates that many breast cancer patients are being over treated; and we see a significant opportunity to employ electron IORT to de-escalate their treatment and significantly improve their quality of life while providing the same clinical effectiveness," said Prof. Jürgen Debus, Medical Director for the Department of Radiation Oncology at Heidelberg University.

"We are proud to sponsor the Cosmopolitan Trial as it strengthens the clinical evidence supporting the role of electron-beam IORT in treating breast cancer," said Derek T. DeScioli, CEO of IntraOp. "As the healthcare industry evolves to value-based care, we expect increased adoption of our technology. Every breast cancer patient should have the option to having their surgery and radiotherapy conveniently completed at the same time."

The American Journal of Managed Care® to Host Patient-Centered Oncology Care® 2020 Conference in Nashville

On April 22, 2020 The American Journal of Managed Care (AJMC), the leading multimedia peer-reviewed journal dedicated to issues in managed care, reported that the Patient-Centered Oncology Care (PCOC) 2020 conference will take place on Sept. 24 and 25 at the OMNI Nashville Hotel in Nashville, Tennessee (Press release, The American Journal of Managed Care, APR 22, 2020, View Source [SID1234556508]).

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The dynamic program will be co-chaired by Joseph Alvarnas, M.D., editor-in-chief of AJMC’s Evidence-Based Oncology (EBO) and vice president of government affairs, senior medical director for employer strategy and associate clinical professor in the department of hematology and hematopoietic cell transplantation at City of Hope; and Kashyap Patel, M.D., associate editor of EBO, chief executive officer of Carolina Blood and Cancer Care Associates, vice president of the Community Oncology Alliance and trustee and clinical affairs chair for the Association of Community Cancer Centers.

"AJMC is proud to host our prestigious conference in Music City this fall," said Michael J. Hennessy Jr., president of MJH Life Sciences, parent company of AJMC. "At PCOC, attendees will be able to network with industry leaders and gain vital insight into the rapidly changing oncology care landscape."

During this two-day, patient-centered conference, featured speakers will engage in panel discussions on policy, precision health, chronic care management, biosimilars and the ways in which technology and telehealth are affecting care and value-based medicine. Attendees will have the opportunity to network with peers and engage with leaders from payer, community, academic and patient advocacy groups on critical issues in oncology value-based care.

"The Patient-Centered Oncology Care conference is a focus factory for disruptive ideas for how to create an innovative, sustainable, and patient-focused future for cancer care in this country. Key cancer stakeholders assemble in this forum to navigate the complexities of changing the ideal of value-based care into a practical reality," said Dr. Alvarnas.

Dr. Patel added, "We look forward defining value to promote quality and improve patient experience in cancer care at the PCOC conference."

NOXXON Pharma N.V. Reports 2019 Financial Results

On April 22, 2020 NOXXON Pharma N.V. (Euronext Growth Paris: ALNOX), a biotechnology company focused on improving cancer treatments by targeting the tumor microenvironment (TME), reported its financial results for the fiscal year ending December 31, 2019 (Press release, NOXXON, APR 22, 2020, View Source [SID1234556507]).

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"In 2019 the team at NOXXON along with dedicated and determined doctors and hospital staff managed to advance multiple NOX-A12 combination clinical trials in difficult-to-treat solid cancers. Despite the ongoing COVID-19 pandemic, this team has successfully continued the NOX-A12 + radiotherapy clinical trial for first line brain cancer patients. We believe that NOX-A12 and NOX‑E36 represent unique approaches to address the tumor microenvironment and we look forward to driving these programs further through clinical development and ultimately bringing them to patients in collaboration with strategic partners," said Aram Mangasarian, CEO of NOXXON.

Highlights for 2019 and 2020 Year-to-Date

NOX-A12 + Radiotherapy Clinical Trial in First Line Brain Cancer Patients Initiated

In September 2019, the company initiated a Phase 1/2 clinical trial testing the combination of radiotherapy and NOX-A12 in newly diagnosed brain cancer patients for up to six months. The study investigates three dose regimens of NOX-A12 (200, 400 and 600 mg/week), each combined with external-beam radiotherapy. In a planned assessment in December 2019, an independent Data Safety Monitoring Board (DSMB) had analyzed safety data from ten weeks of treatment of the first patient and confirmed that it was safe and appropriate to continue the recruitment of additional patients according to the study protocol. Recruitment of the patients of the first dose cohort was completed in March 2020. The DSMB will reconvene at the end of April 2020 to determine whether it is safe to proceed from the low to the middle dose regimen of NOX-A12. Provided that the results from this ongoing clinical trial are positive, NOXXON will seek advice from competent authorities under its orphan drug designation in the United States and Europe to identify the most efficient manner to complete development in this indication. Recruitment of new patients continues despite the COVID-19 pandemic.

NOX-A12 + Immunotherapy Clinical Trial in Heavily Pre-Treated Metastatic Pancreatic and Colorectal Cancer Patients

In September 2019, the company reported updated data from the clinical trial of the combination of NOX-A12 with Keytruda in heavily pre-treated metastatic micro-satellite stable pancreatic and colorectal cancer patients. One of the most interesting aspects of the results was the updated overall survival data showing that three patients including two receiving their fourth line of therapy for metastatic pancreas cancer had lived more than one year. Overall, data from this study has so far demonstrated 25% of patients achieved stable disease according to the iRECIST criteria, despite 95% of all patients having progressive disease as their best response to their prior anti-cancer treatment. Furthermore, 35% of patients had prolonged time on therapy, relative to their prior treatment. As such, further work in both tumor types is warranted for NOX-A12. NOXXON is now discussing the plans for the next steps of NOX-A12 + immunotherapy development with industrial partners and clinical experts to ensure that key stakeholders have been consulted on our upcoming trial(s). The goal is to identify a collaboration partner who will financially support the further development of NOX-A12 in colorectal and pancreatic cancer.

In June 2019, a leading international pharmaceutical company signed an agreement with NOXXON to evaluate NOX-A12 in an undisclosed non-oncology indication. The pharmaceutical company has been investigating a broader therapeutic profile of NOX-A12 in an indication which is a serious disease with significant unmet medical need. The market for this indication has been valued at more than a billion euros. NOXXON supplied NOX-A12 to the pharmaceutical company that has funded and been conducting the preclinical studies. The evaluation results are anticipated in Q2‑2020.

Strengthening its cash position and financing clinical objectives have been a key priority for NOXXON. Despite an unfavorable financing climate, the company raised € 1.5 million in 2019 and an additional € 1 million in January 2020 through capital increases. The support came from the historical investment community as well as a new group of European investors representing small funds and family offices. Importantly, there were no warrants or other option-like instruments attached to these financing rounds.

2019 Financial Summary

In both, Fiscal Year 2019 (FY 2019) and Fiscal Year 2018 (FY 2018), NOXXON, did not generate any revenues. The Group – NOXXON Pharma N.V. and NOXXON Pharma AG – does not expect to generate revenues until the signing of strategic collaborations or the successful commercialization of product candidates.

Other operating income decreased from € 378 thousand in FY 2018 to € 279 thousand in FY 2019 on an overall basis and results from the sale of raw materials and a partial waiver of management and supervisory board members concerning their receivables from remuneration due from the Group in 2019 being lower than the partial waiver of management and supervisory members concerning their receivables from remunerations due from the Group and other income in 2018.

Research and development (R&D) expenses decreased from € 2,205 thousand in FY 2018 to € 2,108 thousand in FY 2019. The decrease in R&D expenses in 2019 compared to 2018 is mainly due to lower personnel expenses, partly offset by higher costs for production of drug substances, service fees and other costs related to clinical trials and preclinical testing as well as higher patent and consulting services costs. Personnel expenses include non-cash share-based payment expenses amounting to € 53 thousand in 2019 and € 119 thousand in 2018. When such non-cash share-based payment expenses are not taken into account, the remaining personnel expenses are € 530 thousand in 2019 and € 625 thousand in 2018.

General and administrative (G&A) expenses decreased from € 2,492 thousand in FY 2018 to € 2,115 thousand in FY 2019. The decrease in G&A expenses in 2019 is mainly driven by lower personnel as well as public and investor relations expenses compared to 2018, partly offset by higher legal, consulting and audit fees and other expenses. Personnel expenses include non-cash share-based payment expenses amounting to € 54 thousand in 2019 and € 278 thousand in 2018. When such non-cash share-based payment expenses are not taken into account, the remaining personnel expenses are € 741 thousand in 2019 and € 922 thousand in 2018.

Foreign exchange losses decreased from € 48 thousand in FY 2018 to € 4 thousand in FY 2019 due to financing transactions and a higher volume of purchases denominated in currencies other than euro in FY 2018.

Finance income (all non-cash) increased from € 388 thousand in FY 2018 to € 3,091 thousand in FY 2019. Finance income in FY 2019 was mainly due to the reduction of the financial liability payable on demand and due to Acuitas by € 3,013 thousand. A further € 72 thousand of finance income resulted from the fair value adjustment of warrants issued and outstanding to Yorkville, Kreos and other investors and the remaining € 6 thousand resulted from the cashless exercise of warrants by Acuitas.

Finance costs in FY 2019 and FY 2018 were non-cash finance costs, except for transaction costs of € 133 thousand in 2018 borne by the Group in conjunction with its issuance of convertible bonds. Finance costs decreased from € 6,758 thousand in FY 2018 to € 3 thousand in FY 2019.

As a result of the above factors, the Group’s loss before income tax decreased by € 9,877 thousand from € 10,737 thousand in FY 2018 to € 860 thousand in FY 2019. The reduction of net loss is predominately driven by non-cash effects resulting from finance income and finance cost.

On December 31, 2019, the Group had cash resources of € 1.4 million (compared to € 4.3 million on December 31, 2018). The Group succeeded in raising € 1.5 million in cash during the financial year 2019 from investors buying shares. Importantly, no warrants or other option-like instruments were attached to the shares issued in these financings. The continued support of investors willing to purchase shares in this manner is key for NOXXON to reduce reliance on instruments that have the potential to create divergent interests between various groups of investors. These financings were essential to allow NOXXON continue follow-up of patients in the NOX-A12/Keytruda trial in pancreatic and colorectal cancer patients, and to initiate the NOX-A12/radiotherapy combination trial in brain cancer patients. On December 31, 2019, a significant number of warrants linked to previous financings and subject to anti-dilution adjustments affecting exercise price and number of shares issued were outstanding. Before the date of the Annual Report, Acuitas executed its right to cashless exercise for all of its remaining warrants.

Outlook 2020

The current budget projects a cash need of approximately € 400 thousand per month, including working capital and all planned activities for the brain cancer trial. Current cash resources are projected to finance the Group into July 2020. As such, it is a key priority for the company to raise additional funds before the end of June 2020 in order to continue its operations.

Management is pursuing various financing alternatives to meet the Group’s future cash requirements. While management is confident to be able to raise additional capital and its preference is to do so via private placement of shares to long-term investors or industrial partnerships, market conditions and restrictions on many activities resulting from the COVID-19 pandemic have made it more difficult. As such, management has been working in parallel on alternative financing vehicles, such as convertible debt and assesses these financing alternatives by how well they meet the following key criteria: potential to meet financial needs of the Group through multiple key value inflection points; absence of warrants or option-like instruments creating long-term overhang; flexibility to end plan at any time; timing and decision to take additional money being under control of the Group; ability of the Group to buy out any unconverted instruments; extent of restrictions on M&A or asset sales; discount on financing consistent with investment risk; and potential to impact on share price.

The Annual Report 2019, as approved by the management and supervisory boards on April 21, 2020, is available on NOXXON’s website (www.noxxon.com).

Arrowhead Pharmaceuticals to Webcast Fiscal 2020 Second Quarter Results

On April 22, 2020 Arrowhead Pharmaceuticals Inc. (NASDAQ: ARWR) reported that it will host a webcast and conference call on May 7, 2020, at 4:30 p.m. EDT to discuss its financial results for the fiscal second quarter ended March 31, 2020 (Press release, Arrowhead Pharmaceuticals, APR 22, 2020, View Source [SID1234556506]).

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Conference Call and Webcast Details

Investors may access a live audio webcast on the Company’s website at View Source For analysts that wish to participate in the conference call, please dial 855-215-6159 or 315-625-6887 and provide Conference ID 7566917.

A replay of the webcast will be available on the company’s website approximately two hours after the conclusion of the call and will remain available for 90 days. An audio replay will also be available approximately two hours after the conclusion of the call and will be available for 3 days. To access the audio replay, dial 855-859-2056 or 404-537-3406 and provide Conference ID 7566917.

BIOGEN REPORTS Q1 2020 REVENUES OF $3.5 BILLION

On April 22, 2020 Biogen Inc. (Nasdaq: BIIB) reported first quarter 2020 financial results (Press release, Biogen, APR 22, 2020, View Source [SID1234556505]).

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"The COVID-19 pandemic has created a challenging situation for people and companies throughout the world, and Biogen personally felt the painful impact of this global crisis. During these challenging and unprecedented times, Biogen has continued to deliver on its mission and purpose," said Michel Vounatsos, Biogen’s Chief Executive Officer. "We have continued to operate our business and deliver our therapies to patients across the world and are especially grateful to our dedicated employees as we continue to execute on our strategy."

Mr. Vounatsos added, "We delivered strong financial results in the first quarter, and we continued to develop and expand our pipeline, including making good progress toward the U.S. regulatory filing for aducanumab, as well as bolstering our efforts in gene therapy through a collaboration with Sangamo. The magnitude and uncertainty surrounding this pandemic clearly introduce unanticipated and potentially unquantifiable risks to our business and results over the near-term. That said, we believe that compelling opportunities exist in the therapeutic areas we are pursuing. This crisis has had a profound impact on our organization and the world at large. We have taken a broad set of actions, and we will remain fully engaged."

Financial Results

• First quarter total revenues were $3,534 million, a 1% increase versus the first quarter of 2019.
o Multiple sclerosis (MS) revenues, including $162 million in royalties on the sales of OCREVUS, increased 9% versus the prior year to $2,280 million.
o SPINRAZA revenues increased 9% versus the prior year to $565 million.
o Biosimilars revenues increased 25% versus the prior year to $219 million.
2 o Other revenues decreased 63% versus the prior year to $109 million primarily due to the sale of approximately $200 million of hemophilia inventory to Bioverativ Inc. in the first quarter of 2019.
o Biogen estimates that its first quarter product revenues benefitted by approximately $100 million attributed to accelerated sales due to the COVID-19 pandemic, primarily in Europe.
o Additionally, Biogen’s MS revenues in the U.S. benefitted by approximately $54 million due to extra shipping days versus the prior year and prior quarter.

• First quarter GAAP net income and diluted earnings per share (EPS) attributable to Biogen Inc. were $1,399 million and $8.08, respectively, compared to $1,409 million and $7.15, respectively, in the first quarter of 2019.
• First quarter Non-GAAP net income and diluted EPS attributable to Biogen Inc. were $1,582 million and $9.14, respectively, compared to $1,374 million and $6.98, respectively, in the first quarter of 2019.

A reconciliation of GAAP to Non-GAAP quarterly financial results can be found in Table 3 at the end of this news release.

Aducanumab Update Biogen provided the following update regarding aducanumab, an anti-amyloid beta antibody candidate for the potential treatment of Alzheimer’s disease that Biogen is developing in collaboration with Eisai Co., Ltd.:

• Biogen has an open Biological License Application (BLA) with the U.S. Food and Drug Administration (FDA) and has started to submit modules of the filing.
• Biogen has participated in additional formal interactions with the FDA using mechanisms such as Type C meetings and is preparing for a pre-BLA meeting, currently scheduled for the summer of 2020.
• Following the pre-BLA meeting, Biogen expects to complete the U.S. filing in the third quarter of 2020.

In the first quarter of 2020 channel inventory levels in the U.S. decreased by approximately $115 million for TECFIDERA, VUMERITY, AVONEX, PLEGRIDY, and TYSABRI combined. This compares to a decrease in inventory levels of approximately $170 million in the first quarter of 2019 and an increase of approximately $145 million in the fourth quarter of 2019.

• In the first quarter of 2020 SPINRAZA revenues comprised $235 million in sales in the U.S. and $330 million in sales outside the U.S. The number of commercial patients 4 receiving SPINRAZA grew approximately 1% in the U.S. and approximately 10% outside the U.S. versus the fourth quarter of 2019. R&D expense in the first quarter of 2019 included approximately $39 million related to Biogen’s agreement with Skyhawk Therapeutics, Inc. and approximately $45 million in net closeout costs for the Phase 3 studies of aducanumab in Alzheimer’s disease.

• R&D expense in the fourth quarter of 2019 included $63 million related to the transaction with Samsung Bioepis Co., Ltd., $45 million related to the option exercise for BIIB080 (tau ASO), and $30 million related to collaboration agreements with CAMP4 Therapeutics and Catalyst Biosciences, Inc. Other Financial Highlights

• In the first quarter of 2020 Biogen recognized a GAAP-only charge of $75 million related to its acquisition of BIIB118 (previously known as PF-05251749) from Pfizer Inc. (Pfizer).

• For the first quarter of 2020 GAAP and Non-GAAP collaboration profit sharing was $72 million.

• For the first quarter of 2020 GAAP other expense was $120 million, which included $61 million in unrealized losses on investments, principally driven by a decrease in the fair value of Biogen’s equity investment in Ionis Pharmaceuticals, Inc. Non-GAAP other expense for the first quarter of 2020 was $60 million driven by net interest expense, foreign exchange losses, and losses on security sales.

• For the first quarter of 2020 the Company’s effective GAAP tax rate was approximately 17%, a reduction from approximately 23% in the first quarter of 2019 due in part to the planned divestiture of our Hillerød, Denmark manufacturing operations and unrealized gains taxable at higher tax rates, both in Q1 2019. For the first quarter of 2020 the Company’s effective Non-GAAP tax rate was approximately 17%, compared to approximately 18% in the first quarter of 2019.

5 • In the first quarter of 2020 Biogen repurchased approximately 7.3 million shares of the Company’s common stock for a total value of approximately $2,220 million. o As of March 31, 2020, the share repurchase program authorized in March 2019 had been completed, and approximately $4,059 million remained under the share repurchase program authorized in December 2019.

• As of March 31, 2020, Biogen had cash, cash equivalents, and marketable securities totaling approximately $4,830 million and approximately $5,962 million in notes payable.

• In the first quarter of 2020 the Company generated approximately $1,467 million in net cash flows from operations. • For the first quarter of 2020 the Company’s weighted average diluted shares were 173 million. Biogen’s Response to COVID-19 To help ensure the health and safety of all stakeholders and society, Biogen has taken several actions in response to the ongoing COVID-19 pandemic, including:

• Implementing policies and practices to safeguard employees and communities to reduce the spread of COVID-19, including asking almost all employees to work from home.

• Providing medical equipment and supplies to Partners Healthcare in Massachusetts to help diagnose COVID-19 in a greater number of people and donating 3D-printed personal protective equipment in Massachusetts and North Carolina. • Committing $10 million from the Biogen Foundation to support global response efforts and communities around the world.

• Facilitating volunteer efforts by medically trained employees to serve as healthcare workers on the front lines and by other employees to serve the community.

• Engaging with investigators who may want to evaluate the potential of our interferon therapies to treat COVID-19.

• Launching a consortium with the Broad Institute of MIT and Harvard and Partners Healthcare to build and share a COVID-19 biobank and giving Biogen employees who have recovered from COVID-19, as well as their close contacts, the opportunity to donate samples and medical data.

• Pursuing a process development and manufacturing collaboration with Vir Biotechnology, Inc., which is developing potential antibody therapies for COVID-19. 6 Potential Business Impacts of COVID-19 Biogen has continued to operate its business to serve the needs of patients and has been continually monitoring for potential impacts: • Supply chain: Biogen has continued to operate its manufacturing facilities and is working with organizations across its supply chain to maintain continuity, while continuing to closely monitor the evolving situation.

• Regulatory interactions: Biogen is continuing its frequent interactions with regulatory authorities, including for aducanumab.

• Clinical trials: Biogen is working on a case-by-case basis to continue safely advancing as many of its clinical trials as possible. To help mitigate the impact to its clinical trials, the Company is pursuing innovative approaches such as remote monitoring, remote patient visits, and supporting home infusions. While Biogen does expect there will be some impact to timelines for some of its clinical programs, it still expects the vast majority of the 10 remaining near-term readouts to occur before the end of 2021. Recent Events

• In April 2020 Biogen, Broad Institute of MIT and Harvard, and Partners HealthCare announced a consortium that will build and share a COVID-19 biobank. The biobank will help scientists study a large collection of de-identified biological and medical data to advance scientific knowledge and search for potential vaccines and treatments for COVID-19. Biogen will help employees who wish to volunteer connect with the project. The initial volunteers are among the first people in Massachusetts to be diagnosed with and recover from COVID-19, as well as close contacts of those individuals.

• In April 2020 the previously announced collaboration between Biogen and Sangamo Therapeutics, Inc. (Sangamo) to develop gene regulation therapies for Alzheimer’s disease, Parkinson’s disease, neuromuscular disease, and other neurological diseases became effective. The companies will leverage Sangamo’s proprietary zinc finger protein technology delivered via adeno-associated virus to modulate the expression of key genes involved in neurological diseases. Upon closing of this transaction, Biogen paid Sangamo $225 million for the purchase of new Sangamo stock, or approximately 24 million shares at $9.21 per share, and will pay a $125 million license fee in the second quarter of 2020. In addition, Biogen may pay Sangamo up to $2.37 billion in other milestone payments as well as tiered high single digit to sub-teen double-digit royalties.

• In April 2020 Biogen delivered an encore presentation of the Phase 3 topline results for aducanumab at the virtual AAT-AD/PDTM focus meeting. The data in this presentation were previously presented at the Clinical Trials on Alzheimer’s Disease (CTAD) annual congress in December 2019. 7

• In March 2020 the first patient was dosed in the global clinical study, DEVOTE, which is evaluating the safety, tolerability, and potential for even greater efficacy of SPINRAZA when administered at a higher dose than currently approved for the treatment of spinal muscular atrophy (SMA). The Phase 2/3 randomized, controlled, dose-escalating study will be conducted at approximately 50 sites around the world and aims to enroll individuals of all ages with SMA.

• In March 2020 Biogen received the topline data from OPUS, a randomized Phase 2 study exploring the efficacy, safety, and tolerability of natalizumab as an adjunctive therapy in adults with drug-resistant focal epilepsy. Though safety data were in-line with the known safety profile of natalizumab, and target engagement as assessed by alpha-4 integrin saturation was achieved, the primary endpoint was not met. As a result, Biogen has decided to discontinue development of natalizumab in drug-resistant focal epilepsy.

• In March 2020 a study on the efficacy and safety of SPINRAZA in teen and adult patients was published in Lancet Neurology, showing clinically meaningful improvements in motor function in a real-world cohort. This study included 139 teens and adults with later-onset SMA (age 16-65 years) from 10 neuromuscular treatment centers in Germany. Patients were followed for 6-14 months and experienced statistically significant increases in HFMSE (Hammersmith Functional Motor Scale Expanded) scores compared to baseline at 6 months, 10 months, and 14 months. Clinically meaningful improvements (≥3 points increase) in HFMSE scores were seen in 28% of patients at 6 months, 35% of patients at 10 months, and 40% of patients at 14 months. The most frequent adverse events were headache, back pain, and nausea.

• In March 2020 the first patient was dosed in the aducanumab re-dosing study, EMBARK, in line with Biogen’s commitment to offer aducanumab to eligible patients who were previously in aducanumab clinical studies. EMBARK is a global re-dosing clinical study designed to evaluate aducanumab in eligible Alzheimer’s disease patients who were actively enrolled in aducanumab studies (PRIME, EVOLVE, EMERGE, and ENGAGE) in March 2019.

• In March 2020 Biogen completed its acquisition of BIIB118 from Pfizer. BIIB118 is a novel CNS-penetrant small molecule inhibitor of casein kinase 1 (CK1), for the potential treatment of patients with behavioral and neurological symptoms across various psychiatric and neurological diseases. In particular, Biogen plans to develop the Phase 1 asset for the treatment of sundowning in Alzheimer’s disease and irregular sleep wake rhythm disorder in Parkinson’s disease. The purchase included an upfront payment of $75 million with up to $635 million in potential additional development and commercialization milestone payments, as well as tiered royalties in the high single digits to sub-teens.

Conference Call and Webcast

The Company’s earnings conference call for the first quarter will be broadcast via the internet at 8:00 a.m. ET on April 22, 2020, and will be accessible through the Investors section of Biogen’s website, www.biogen.com. Supplemental information in the form of a 8 slide presentation is also accessible at the same location on the internet and will be subsequently available on the website for at least one month.