On August 4, 2020 Acorda Therapeutics, Inc. (NASDAQ: ACOR) reported its financial results for the second quarter ended June 30, 2020 (Press release, Acorda Therapeutics, AUG 4, 2020, View Source [SID1234562781]).

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 were pleased with INBRIJA’s performance in the second quarter, especially in light of the significant disruption of COVID-19. Net sales increased by 7% over the first quarter, and dispensed cartons, which reflect actual demand, increased by 13%. This trend continued into July, with dispensed cartons increasing 8% over June, to the highest number since the beginning of the launch," said Ron Cohen, M.D., Acorda’s President and Chief Executive Officer. "We also saw several indications that our programs to improve the experience of patients and physicians are having a positive effect. INBRIJA new prescription requests, which declined dramatically beginning in mid-March, began to rebound in late April and have continued to increase through July. We also saw a 6% increase in new prescribers in the quarter, and the percent of new prescription requests that converted to filled prescriptions increased to 75%, up from 57% in Q1, the highest rate since launch."

Dr. Cohen continued, "We incurred higher-than-expected Medicare rebates in the first half of the year, which impacted net sales. We believe that such rebates are likely to be lower in the second half of 2020, as more patients get through the Medicare Part D donut hole."

Second Quarter 2020 Financial Results

For the quarter ended June 30, 2020, the Company reported INBRIJA net revenue of $4.7 million, compared to $3.0 million for the same quarter in 2019.

For the quarter ended June 30, 2020, the Company reported AMPYRA net revenue of $26.1 million compared to $44.2 million for the same quarter in 2019. In September 2018, AMPYRA lost its exclusivity and generics entered the market. Consequently, the Company expects AMPYRA revenue to continue to decline.

Research and development (R&D) expenses for the quarter ended June 30, 2020 were $5.3 million, including $0.4 million of share-based compensation compared to $19.0 million, including $0.8 million of share-based compensation for the same quarter in 2019.

Sales, general and administrative (SG&A) expenses for the quarter ended June 30, 2020 were $38.7 million, including $1.5 million of share-based compensation compared to $50.2 million, including $3.5 million of share-based compensation for the same quarter in 2019.

Change in fair value of derivative liability for the quarter ended June 30, 2020 was $8.9 million.

Provision for income taxes for the quarter ended June 30, 2020 was $0.6 million compared to a provision for income taxes of $0.2 million for the same quarter in 2019.

The Company reported a GAAP net loss of $17.4 million for the quarter ended June 30, 2020, or $0.37 per diluted share. GAAP net loss in the same quarter of 2019 was $27.5 million, or $0.58 per diluted share.

Non-GAAP net loss for the quarter ended June 30, 2020 was $16.6 million, or $0.35 per diluted share. Non-GAAP net loss in the same quarter of 2019 was $26.3 million, or $0.55 per diluted share. This quarterly non-GAAP net loss measure, more fully described below under "Non-GAAP Financial Measures," excludes share-based compensation charges, non-cash interest charges on our debt, changes in the fair value of acquired contingent consideration, and changes in the fair value of the derivative liability. A reconciliation of the GAAP financial results to non-GAAP financial results is included with the attached financial statements.

At June 30, 2020, the Company had cash, cash equivalents, short-term investments and restricted cash of $103.8 million compared to $168.9 million at year end 2019. Restricted cash includes $37.3 million in escrow related to the 6% semi-annual interest portion of the convertible note exchange completed in December 2019. If the Company is permitted under the terms of the notes and elects to pay interest due in stock, the restricted cash will be released from escrow.

For the full-year 2020, Acorda continues to expect AMPYRA net revenue to be $85 – $110 million, and operating expenses to be $170 – $180 million. The operating expense guidance is a non-GAAP projection that excludes restructuring costs and share-based compensation as more fully described below under "Non-GAAP Financial Measures."

Webcast and Conference Call

The Company will host a conference call today at 4:30 p.m. ET. To participate in the Webcast/Conference call, please note there is a new pre-registration process.

• To register for the Webcast, use the link below:
View Source

• To register for the Conference Call, use the link below:
View Source
**When registering please type your phone number with no special characters**.

A replay of the call will be available from 8:30 p.m. ET on August 4, 2020 until 11:59 p.m. ET on September 3, 2020. To access the replay, please dial (800) 585-8367 (domestic) or (416) 621-4642 (international); reference code 5378839. The archived webcast will be available in the Investor Relations section of the Acorda website at www.acorda.com.

On August 4, 2020 Cardiff Oncology, Inc. (Nasdaq: CRDF), a clinical-stage oncology therapeutics company developing drugs to treat cancers with the greatest medical need for new treatment options, including KRAS-mutated colorectal cancer, castration-resistant prostate cancer and leukemia, reported that the Company will participate in the BTIG Biotechnology Virtual Conference taking place August 10-11, 2020 (Press release, Cardiff Oncology, AUG 4, 2020, View Source [SID1234562780]).
Presenter: Dr. Mark Erlander, chief executive officer
Topic: KRAS Inhibition in Solid Tumors – Material Advancements and Continuing Challenges
Date: Monday, August 10, 2020
Time: 12:30 p.m. PT / 2:30 p.m. CT / 3:30 p.m. ET.

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!

The discussion with Cardiff Oncology will focus on the Company’s oral and highly selective Polo-like Kinase 1 (PLK1) inhibitor, onvansertib, and its promise as a new therapeutic option in KRAS-mutated metastatic colorectal cancer, which has historically been a very challenging indication to effectively target and treat.

Conference attendees are welcome to join the fireside chat via the conference portal.

On August 4, 2020 Ascendis Pharma A/S (Nasdaq: ASND), a biopharmaceutical company that utilizes its innovative TransCon technologies to address unmet medical needs, reported that the company will participate in two upcoming investor conferences in August (Press release, Ascendis Pharma, AUG 4, 2020, View Source [SID1234562767]). Company executives will provide a business overview and update on the company’s pipeline programs.

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!

Details

Event 2020 Wedbush PacGrow Healthcare Virtual Conference
Location Virtual
Date Tuesday, August 11, 2020
Time 2:20 p.m. Eastern Time

Event Canaccord Genuity 40th Annual Growth Conference
Location Virtual
Date Wednesday, August 12, 2020
Time 1:30 p.m. Eastern Time
A live webcast of the presentations will be available in the Investors and News section of the Ascendis Pharma website at www.ascendispharma.com. A webcast replay will also be available on this website shortly after conclusion of the events for 30 days.

On August 4, 2020 MEI Pharma, Inc. (NASDAQ: MEIP) ("MEI"), a late-stage pharmaceutical company focused on advancing new therapies for cancer, reported that Daniel P. Gold, Ph.D., president and chief executive officer of MEI, will present a company overview and business update at the BTIG Virtual Biotechnology Conference 2020 on Tuesday, August 11th, 2020 at 11:00 AM Eastern Time (Press release, MEI Pharma, AUG 4, 2020, View Source [SID1234562766]). The conference is being held in a virtual format.

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 event can be accessed on the Events & Presentations page of the Investors section of MEI Pharma’s website at View Source An archived replay of the webcast will be available on MEI Pharma’s website for at least 30 days after the live event concludes.

On August 4, 2020 Astellas Pharma US, Inc. ("Astellas") reported the call for entries for the Astellas Oncology C3 Prize (Changing Cancer Care), a global challenge that funds the best non-treatment ideas to improve cancer care for patients, caregivers and their loved ones (Press release, Astellas, AUG 4, 2020, View Source [SID1234562765]). Now in its fifth year, the C3 Prize will award grants and resources totaling $200,000 to concepts that address everyday challenges facing people impacted by cancer. In particular this year, solutions that also ease the increased burden of COVID-19 on cancer care, as well as address health disparities affecting cancer patients, are encouraged.

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!

The C3 Prize is open to all applicants through September 28. Astellas will select the finalists in December 2020. Each finalist will participate in a pitch event in March 2021 to determine the prize winners. Additional applicant information is available at www.C3Prize.com.

"Over the past five years we have sourced hundreds of ideas from people who embody the Astellas Oncology mission to make every day better for those living with cancer," said Mark Reisenauer, senior vice president, oncology business unit, Astellas US. "The COVID-19 pandemic, as well as existing health disparities, adds to the complexity of cancer care, creating additional emotional, financial and physical strain for people impacted by cancer, their loved ones and the medical professionals who care for them. The C3 Prize is uniquely designed to elicit the best ideas to address these challenges."

Cultivating Ideas that Unify Care Around People Living with Cancer
The C3 Prize is not just for complex solutions – ideas can be in the form of support tools, educational efforts, technology solutions and beyond. Past winners include people who have lived with cancer, caregivers, healthcare providers, patient advocates, entrepreneurs and more. Their winning ideas have included a video game designed to keep pediatric patients active and informed, a specialized childcare network that provides stability and normalcy for families, and a first-of-its kind and easy-to-understand digital audio series about cancer.

Celebrity entrepreneur and cancer activist Bill Rancic is lending his support to the 5th Annual C3 Prize for the third consecutive year to generate awareness about the importance of fostering advances in cancer beyond medicine and as host of the pitch event.

"As the husband of a cancer survivor, it’s been an honor to be a part of an effort that puts a spotlight on life-changing cancer care solutions that ease the burden of the cancer journey for patients and their families," Rancic said. "I’ve been inspired and impressed by the creativity of the submissions we have received over the years, and I encourage anyone with an idea or concept to apply."

Tackling Everyday Challenges Facing the Cancer Community
The 5th Annual C3 Prize finalists will participate in a pitch event with an expert panel of volunteer judges: Mark Reisenauer, senior vice president, oncology business unit, Astellas; Margaret Laws, president and CEO, Hopelab; Ebele Mbanugo, executive director, Run for a Cure Africa; Steve Alperin, CEO, SurvivorNet and Steven Collens, CEO, MATTER.

"I’ve dedicated my life to cancer education and awareness, and through my experience with the C3 Prize I have learned that one good idea can make an immeasurable difference," said Ebele Mbanugo, 2018 C3 Grand Prize winner, 2020 C3 Prize judge and founder/executive director of the nonprofit organization Run For a Cure Africa (RFCA). "Through the grants we’ve received from the C3 Prize to help fund my idea, we’ve been able to provide more comprehensive care for breast cancer patients living in Nigeria."

Astellas Oncology will award the Grand Prize winner $100,000 USD in grants, and the two Innovation Prize winners $50,000 USD in grants each. All winners will be provided with access to tools and resources to help them develop and advance their idea, including a yearlong complimentary membership to MATTER, a global healthcare startup incubator, community nexus and corporate innovation accelerator.

All eligible entries will be evaluated on the following criteria: potential impact on people affected by cancer, originality/differentiation from existing solutions, scalability of idea, and the impact of the C3 Prize on the ability to further the idea.

For more information, visit www.C3Prize.com.

About the Astellas Oncology C3 Prize
The Astellas Oncology C3 Prize, launched in 2016, is a global challenge that aims to address the complexities of the cancer journey by funding the best ideas in cancer care beyond medicine. The C3 Prize sparks innovative developments in cancer care, tackling cancer challenges by awarding the winners with prize money and connecting them with resources and support. The C3 Prize directly reflects the mission of Astellas Oncology: striving to make every day better for those impacted by cancer. Astellas maintains no ownership in the ventures funded by the C3 Prize. For more information, visit the website at View Source and follow on social media with the hashtag, #C3Prize.