On March 9, 2021 Eiger BioPharmaceuticals, Inc. (Nasdaq: EIGR), a commercial-stage biopharmaceutical stage company focused on the development and commercialization of foundational therapies for Hepatitis Delta Virus (HDV) infection, reported financial results for fourth quarter and full year 2020 and provided a business update (Press release, Eiger Biopharmaceuticals, MAR 9, 2021, View Source [SID1234576353]).

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"In 2021, we plan to achieve important, value creating milestones in both of our HDV clinical programs," said David Cory, President and CEO of Eiger. "We will complete enrollment of the Phase 3 D-LIVR study of Lonafarnib, the first and only oral agent in development for HDV, and we will initiate the Phase 3 LIMT-2 study of Lambda, a well-tolerated interferon. Lonafarnib and Lambda are potential foundational treatments for HDV that will offer convenience and optionality for patients affected by this serious disease."

Program & Product Updates

Lonafarnib for HDV

First and only oral therapy in development for HDV
Global Phase 3 D-LIVR study enrollment completion planned in 2021
Peginterferon Lambda for HDV

Well-tolerated interferon with weekly subcutaneous injection
Global Phase 3 LIMT-2 study initiation planned in 2021
Zokinvy (lonafarnib) for Progeria and Processing-Deficient Progeroid Laminopathies

U.S. commercial launch in January 2021
EMA decision expected in 2H21
Lambda for COVID-19

Positive Phase 2 ILIAD study in Lancet Respiratory Medicine (Feld et al, 2021)
Considering strategic options to advance program
Avexitide for Post-Bariatric Hypoglycemia (PBH)

Positive Phase 2 PREVENT study published in JCEM (Craig et al, 2021)
Corporate

Pro-forma cash, cash equivalents and investments of $176.2M, including $128.8M as of December 31, 2020 plus $47.4M from net PRV sale proceeds received in January 2021, expected to fund planned operations through Q4 2023
Fourth Quarter and Full Year 2020 Financial Results

Cash, cash equivalents, and short-term investments as of December 31, 2020 totaled $128.8 million compared to $95.0 million on December 31, 2019. In addition, the Company received net proceeds of $47.4 million in January 2021 for sale of a Priority Review Voucher (PRV) issued in conjunction with FDA approval of Zokinvy.

The Company reported net losses of $18.8 million, or $0.58 per share, and $65.1 million, or $2.31 per share, for fourth quarter and full year 2020, respectively, as compared to $16.9 million, or $0.69 per share, and $70.3 million, or $3.08 per share, for the same periods in 2019.

Research and Development expenses were $12.5 million and $41.6 million for fourth quarter and full year 2020, respectively, as compared to $11.9 million and $51.8 million for the same periods in 2019. The increase in fourth quarter 2020 was primarily due to an increase in regulatory expenses. The decrease in full year 2020 expenses was primarily due to a decrease in contract manufacturing and clinical expenditures, partially offset by an increase in regulatory, headcount related, and other operating expenses.

General and Administrative expenses were $5.4 million and $20.6 million for fourth quarter and full year 2020, respectively, as compared to $4.6 million and $17.1 million for the same periods in 2019. The increases in fourth quarter 2020 and full year 2020 were primarily due to an increase in personnel related expenses attributed to an increase in headcount and an increase in outside services, including consulting and advisory services.

Total operating expenses include non-cash expenses of $2.1 million and $7.8 million for fourth quarter and full year 2020, respectively, as compared to $1.6 million and $6.6 million for the same periods in 2019.

As of December 31, 2020, the company had 33.9 million of common shares outstanding.

On March 9, 2021 Atomwise, a leader in using artificial intelligence (AI) for small -molecule drug discovery, reported it has been named to Fast Company’s prestigious annual list of the World’s Most Innovative Companies for 2021 (Press release, Atomwise, MAR 9, 2021, https://www.atomwise.com/2021/03/09/atomwise-named-to-fast-companys-annual-list-of-the-worlds-most-innovative-companies-for-2021/ [SID1234576302]). Atomwise was recognized for its unmatched AI platform, AtomNet️, as well as its growing pipeline and portfolio of partnerships and joint ventures tackling some of the most challenging targets in small molecule drug development.

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The list honors businesses that have not only found a way to be resilient in the past year, but also turned those challenges into impact-making processes. These companies did more than survive, they thrived—making an impact on their industries and culture as a whole. This year’s Most Innovative Companies list features 463 businesses from 29 countries.

"The Atomwise team is honored for this recognition from Fast Company," said Dr. Abraham Heifets, PhD, CEO and co-founder of Atomwise. "Achievements like these are a testament to our team’s hard work and dedication to addressing unmet needs for human disease."

Atomwise’s proprietary approach to identifying small molecules for challenging diseases has landed the startup market validation and recognition. With the addition of its robust internal R&D pipeline, the company has made headway to grow its portfolio. Additionally the company has made major traction with corporate partners that include top-tier pharmaceutical companies like Eli Lilly and Bayer, and emerging biotechnology companies in APAC like GC Pharma, Hansoh Pharmaceuticals and Bridge Biotherapeutics. The company recently unveiled its growing portfolio of emerging joint venture companies, with drug development programs spanning oncology, immunology, infectious disease, neuroscience and clotting disorders.

The company was also recognized for making notable traction in the area of infectious disease in a very short time. In 2020 the company was awarded a $2.3M grant from the Bill and Melinda Gates Foundation to support the development of multiple global health programs to advance novel antimalarial and anti-tuberculosis small molecule therapies in collaboration with the foundation’s global network. Earlier that same year, Atomwise announced fifteen research collaborations underway with leading global universities to discover novel broad -spectrum antivirals for COVID-19 and other coronaviruses, marking the company’s ability to rapidly spin up multiple programs that tackle different disease mechanisms in parallel. The company also founded a joint venture, vAirus, to develop broad -spectrum antivirals against flaviviruses, a notorious family of viruses that include Zika virus, dengue fever, and West Nile virus.

Fast Company’s editors and writers sought out the most groundbreaking businesses across the globe and industries. They also judged nominations received through their application process.

The World’s Most Innovative Companies is Fast Company’s signature franchise and one of its most highly anticipated editorial efforts of the year. It provides both a snapshot and a road map for the future of innovation across the most dynamic sectors of the economy.

"In a year of unprecedented challenges, the companies on this list exhibit fearlessness, ingenuity, and creativity in the face of crisis," said Fast Company Deputy Editor David Lidsky, who oversaw the issue with Senior Editor Amy Farley.
To coincide with the issue launch, Fast Company will host its first-ever Most Innovative Companies Summit on March 9 and 10. This virtual, multiday summit will celebrate the Most Innovative Companies in business, provide an early look at major business trends, and offer the inspiration and practical insights on what it takes to innovate in 2021. Fast Company’s Most Innovative Companies issue (March/April 2021) is now available online here, as well as in app form via iTunes and on newsstands beginning March 16, 2021. The hashtag is #FCMostInnovative.

On March 9, 2021 MorphoSys AG (FSE: MOR; Prime Standard Segment; MDAX & TecDAX; NASDAQ: MOR), a commercial-stage biopharmaceutical company and a leader in antibody, protein and peptide technologies, reported that it will publish its results for the financial year 2020 on March 15, 2021 at 10:00 pm CET (5:00 pm EDT) (Press release, MorphoSys, MAR 9, 2021, View Source [SID1234576318]).

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MorphoSys’ Management team will host a conference call and webcast on March 16, 2021 at 2:00 pm CET (9:00 am EDT) to present results for the financial year 2020 and provide an outlook for 2021.

The conference call will start with a presentation by the Management team followed by a Q&A session. Presenters will be:

– Jean-Paul Kress, M.D., Chief Executive Officer

– Sung Lee, Chief Financial Officer

– Roland Wandeler, Ph.D., Chief Operating Officer

– Malte Peters, M.D., Chief Research & Development Officer

On March 9, 2021 ORCA Therapeutics B.V., a clinical-stage biopharmaceutical company developing oncolytic viruses to treat solid tumors, reported that, upon review of all safety data from the fully enrolled, low- and mid-dose patient cohorts of the ongoing Phase 1/2a clinical study of ORCA-010 in treatment-naïve patients with localized prostate cancer, the independent Data and Safety Monitoring Board (DSMB) unanimously recommended the continuation of the study without modification (Press release, Orca Therapeutics, MAR 9, 2021, View Source [SID1234576354]). From this recommendation, ORCA Therapeutics will initiate administration of the highest scheduled dose level of ORCA-010 in the single dose part of the study.

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Following this recommendation, ORCA Therapeutics B.V. has commenced enrollment in the highest-dose arm of the dose-escalation phase of this study, with the first patient scheduled for administration in March 2021. Upon conclusion of enrollment in the highest study arm, DSMB will conduct an additional review on ORCA-010 prior to starting the repeat dosing part of the trial.

At the lowest dose studied, ORCA-010 demonstrated strong single-agent antitumor activity in the first patient. Further, MRI data reflected an impressive and significant decrease in prostate volume returning to normal size, as well as continuing decreases in PSA. This pattern has been confirmed in the second patient who completed the 6-month follow-up MRI, and also showed prostate volume returning to near normal size.

Investors favorably viewed the DSMB recommendations and the recent clinical success by investing in another round of financing to progress ORCA-010’s development. ORCA-010 has garnered the attention of researchers, recently, ORCA Therapeutics B.V. has initiated discussions to prepare for a study in patients with unresectable/medically inoperable esophageal cancer.

"12% of all men will be diagnosed with prostate cancer in their lifetime. We are encouraged by the safety profile and preliminary efficacy of ORCA-010 and are excited to continue enrollment in the highest dose cohort of this Phase 1/2a study, our first clinical study with ORCA-010," said Kees Groen, ORCA Therapeutics’ CEO. "We are grateful for the continuous support from our investors. The generous contributions enable ORCA Therapeutics to progress ORCA-010’s development for treating prostate cancer."

ORCA Therapeutics B.V.’s two-part Phase 1/2a study is a multi-center, open-label, dose-escalation study of ORCA-010 in approximately 24 treatment-naïve patients with localized prostate cancer:

Part A: Dose-escalation phase to define the safety, tolerability, and optimal dose level of ORCA-010 in treatment-naïve patients with localized prostate cancer. This phase is expected to enroll up to 12 patients in three dose cohorts.

Part B: A subsequent extension of the optimal dose level, as defined in the dose escalation phase, and given as two doses with 2 weeks interval. This phase is expected to enroll approximately 12 additional patients.

On March 9, 2021 Biodesix, Inc. (Nasdaq: BDSX), a leading data-driven diagnostic solutions company with a focus in lung disease, reported that it will release financial results for the fourth quarter and year ended December 31, 2020 after the close of trading on Tuesday, March 16 (Press release, Biodesix, MAR 9, 2021, View Source [SID1234576303]). Biodesix’s management will host a conference call and webcast to discuss its financial results and provide a general business update at 4:30 p.m. Eastern Time on the same day. Dial-in and call details are as follows.

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