On March 12, 2020 ViewRay, Inc. (Nasdaq: VRAY) reported financial results for the fourth quarter and full year ended December 31, 2019 (Press release, ViewRay, MAR 12, 2020, View Source [SID1234555520]). A supplemental presentation for today’s conference call is included on the Company’s website at View Source

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Full Year 2019 Highlights:

Total revenue of $87.8 million compared to 2018 revenue of $81.0 million, which is primarily from 15 revenue units including two system upgrades in each respective year.
Received 22 new orders for MRIdian systems, including three upgrades, totaling $118.5 million, compared to 23 new orders totaling $140.7 million in 2018.
Total backlog increased to $227.3 million as of December 31, 2019, compared to $212.3 million as of December 31, 2018.
Cash and cash equivalents were $226.8 million as of December 31, 2019. The Company received aggregate net proceeds of $138.4 million, after deducting underwriting discounts and commissions and offering expenses payable by the Company, from its December 2019 offering.
Fourth Quarter 2019 Summary:

Total revenue was $16.5 million in the quarter, primarily from three revenue units including one system upgrade, compared to $20.7 million, primarily from four revenue units including one system upgrade, for the same period last year.
Received four new orders for MRIdian systems totaling approximately $21.2 million in the fourth quarter of 2019, compared to eight new orders for MRIdian systems totaling approximately $48.7 million for the same period last year.
"In 2019 we built significant organizational expertise, made progress on our innovation and clinical pipelines, and fortified our balance sheet," said Scott Drake, President and CEO. "As we look at 2020, our commercial and operational activities are being impacted by the coronavirus and may be further impacted depending upon how the situation unfolds. As we look beyond the coronavirus uncertainty, we are confident in the capabilities we have built and how MRIdian is positioned to improve the paradigm of care."

Financial Results

Total revenue for the three months ended December 31, 2019 was $16.5 million compared to $20.7 million for the same period last year. Total revenue for the full year 2019 was $87.8 million compared to $81.0 million for the full year 2018.

Total cost of revenue for the three months ended December 31, 2019 was $20.4 million compared to $20.1 million for the same period last year. Total cost of revenue was $93.3 million for the full year 2019 compared to $74.4 million for the full year 2018.

Total gross (loss) profit for the three months ended December 31, 2019 was $(3.9) million, compared to $0.6 million for the same period last year. Total gross (loss) profit for the full year 2019 was $(5.5) million compared to $6.6 million for the full year 2018.

Total operating expenses for the three months ended December 31, 2019 were $28.4 million, compared to $22.1 million for the same period last year. Total operating expenses for the full year 2019 were $115.3 million for the full year 2019 compared to $81.7 million for the full year 2018.

Net loss for the three months ended December 31, 2019 was $35.2 million, or $0.31 per share, compared to $16.7 million, or $0.17 per share, for the same period last year. Net loss for the full year 2019 was $120.2 million, or $1.18 per share, compared to $79.1 million, or $0.98 per share, for the full year 2018.

ViewRay had total cash and cash equivalents of $226.8 million at December 31, 2019. From its December 2019 offering, the Company received aggregate net proceeds of $138.4 million, after deducting underwriting discounts and commissions and offering expenses payable by the Company.

Financial Guidance

For the full year 2020, ViewRay anticipates total revenue to be in the range of $58 – $95 million, and total cash usage to be in the range of $60 – $80 million. Most notably, commercial and operational activities are being impacted and may be further impacted by the coronavirus. ViewRay has nine planned installations in 2020 in regions that have travel restrictions currently in place.

Conference Call and Webcast

ViewRay will hold a conference call to discuss results on Thursday, March 12, 2020 at 4:30 p.m. ET / 1:30 p.m. PT. The dial-in numbers are (844) 277-1426 for domestic callers and (336) 525-7129 for international callers. The conference ID number is 6095383. A live webcast of the conference call will be available on the investor relations page of ViewRay’s corporate website at www.viewray.com.

After the live webcast, a replay of the webcast will remain available online on the investor relations page of ViewRay’s corporate website, www.viewray.com, for 14 days following the call. In addition, a telephonic replay of the call will be available until March 19, 2020. The replay dial-in numbers are (855) 859-2056 for domestic callers and (404) 537-3406 for international callers. Please use the conference ID number 6095383.

On March 12, 2020 Curis, Inc. (NASDAQ: CRIS), a biotechnology company focused on the development of innovative therapeutics for the treatment of cancer, reported that the Company will release its fourth quarter and full-year 2019 financial results on Thursday, March 19, 2020, after the close of US markets. Management will host a conference call on the same day at 4:30 p.m. ET (Press release, Curis, MAR 12, 2020, View Source [SID1234555460]).

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To access the live conference call, please dial (888) 346-6389 from the United States or (412) 317-5252 from other locations, shortly before 4:30 p.m. ET. The conference call can also be accessed on the Curis website at www.curis.com in the ‘Investors’ section. A replay of the financial results conference call will be available on the Curis website shortly after completion of the call.

On March 12, 2020 CohBar, Inc. (NASDAQ: CWBR), a clinical stage biotechnology company developing mitochondria based therapeutics (MBTs) to treat chronic diseases and extend healthy lifespan, reported its financial results for the fourth quarter ended December 31, 2019 (Press release, CohBar, MAR 12, 2020, View Source [SID1234555488]).

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"We made substantial progress in this past quarter," said Steven Engle, CohBar’s Chief Executive Officer. "We completed the Phase 1a stage of our ongoing Phase 1a/1b clinical trial of CB4211, initiated the Phase 1b stage, and announced promising preclinical data in two new programs, a novel family of CXCR4 antagonists for cancer and other indications, and anti-fibrotic peptides for the potential treatment of fibrotic diseases such as idiopathic pulmonary fibrosis. We now have five mitochondrial derived peptide programs, up from three last summer. These new data provide additional evidence supporting the breadth of biological effects and therapeutic potential of mitochondrial peptides and strengthen our belief that our platform will continue to identify even more mitochondria based therapeutics going forward."

Fourth Quarter 2019 and R&D and Business Highlights

●CB4211 Clinical Study: In November, the company announced the completion of the Phase 1a stage of the company’s ongoing Phase 1a/1b study evaluating the safety, tolerability, and activity of CB4211, and the initiation of recruitment for the Phase 1b stage. The Phase 1b stage is designed to assess the safety, tolerability, and activity of CB4211 in obese subjects with non-alcoholic fatty liver disease (NAFLD). The double-blind, placebo-controlled evaluation will be conducted over four weeks in twenty patients randomized 1:1 to receive either CB4211 or placebo. Assessments will include changes in liver fat as determined by MRI-PDFF, body weight, and biomarkers relevant to NASH and obesity. CohBar has previously presented evidence that the novel mechanism of action of CB4211 enhances insulin effects on fat cells (adipocytes) leading to reduction of liver fat in preclinical models. Clinical data from both stages of the study are expected in the third quarter of 2020.

●New CXCR4 Inhibitor Program for Cancer and Other Indications: Recently, the company announced its discovery of MBT5 analogs, a novel family of potent and selective peptide inhibitors of the chemokine receptor, CXCR4. Analogs of MBT5 have demonstrated high potency at nanomolar levels in in vitro studies of CXCR4 inhibition in cultured cells. In a difficult to treat in vivo animal model of melanoma, the B16F10 syngeneic tumor model, an analog of MBT5 showed enhanced antitumor activity in combination with the chemotherapeutic agent temozolomide. CXCR4 is overexpressed in more than 75% of cancers and high levels of the receptor are associated with poor survival prognosis.

●MBT2 Analogs for Fibrotic Diseases: In December, CohBar announced the further demonstration of the therapeutic potential of a novel peptide in a preclinical model of idiopathic pulmonary fibrosis (IPF). In a therapeutic animal model of IPF, CohBar’s peptide analog, MBT2, demonstrated reductions in all parameters of the disease including lung fibrosis, inflammation, and collagen levels. These data further support earlier positive findings in a prophylactic model of IPF. IPF is a chronic, progressive, debilitating and usually fatal interstitial lung disease that affects approximately 100,000 people in the U.S.

CohBar is continuing to refine and evaluate these novel analogs in preclinical models of multiple indications. In addition, the company continues to develop its programs in cancer immunotherapy and type 2 diabetes.

●Investment Community Outreach: In October 2019, CohBar presented an overview of the company and its clinical development program at the BIO Investor Forum. In January 2020, CohBar met with investors, bankers, and analysts at the JP Morgan Healthcare Conference. In February 2020, CohBar presented at the BIO CEO and Investor conference.

●Expanded the Company’s Board of Directors: In October 2019, Misha Petkevich, Chief Investment Officer of V2M Capital, joined the CohBar board of directors. Mr. Petkevich’s appointment adds extensive financial and investment expertise. His past experience includes roles at V2M Capital, Robertson Stephens & Co. and Hambrecht & Quist.

During the fourth quarter and subsequent period, Dr. Pinchas Cohen and Dr. Nir Barzilai continued to be recognized as international leaders in the study of mitochondrial science, aging and age-related diseases:

Dr. Cohen received the Irving S. Wright Award of Distinction from the American Federation for Aging Research in New York in November 2019. In addition, he delivered a keynote presentation on "Endocrine Gerontology: from IGFs to Mitochondrial Peptides" at the Annual Meeting of the Gerontological Society of America, in Austin, Texas. Dr. Cohen also published a paper entitled "The mitochondrial-derived peptide MOTS-c is a regulator of plasma metabolites and enhances insulin sensitivity" in the journal Physiological Reports.

Dr. Barzilai delivered keynotes at Harvard’s Boston Pepper Center OAIC Mini-Symposium on Geroscience in Boston in December 2019 and at The Science and Economy of Aging World Economic Forum in Davos, Switzerland in January 2020. In January 2020 he also participated in a panel on aging during the JP Morgan Healthcare Conference and at the Longevity Therapeutics conference. Dr. Barzilai authored two articles in the prestigious Nature Medicine Journal, titled "Undulating changes in human plasma proteome profiles across the lifespan" and "Chronic inflammation in the etiology of disease across the lifespan." He also authored two papers on the latest advances in aging research and drug discovery in the Journal of Aging, titled "Screening human embryos for polygenic traits has limited utility" and "Varying Effects of APOE Alleles on Extreme Longevity in European Ethnicities."

Fourth Quarter 2019 Financial Highlights

●Cash and Investments. CohBar had cash and cash equivalents of $12.6 million as of December 31, 2019, compared to $22.2 million as of December 31, 2018. The cash burn for the quarter ended December 31, 2019, was approximately $2.2 million.

●R&D Expenses. Research and development expenses were $1.9 million for the three months ended December 31, 2019, compared to $2.1 million in the prior year quarter. The decrease was primarily due to lower clinical and preclinical costs in the quarter, partially offset by an increase in costs associated with CohBar’s research programs focused on the continuing development of peptides.

●G&A Expenses. General and administrative expenses were $1.7 million for the three months ended December 31, 2019, compared to $2.0 million in the prior year quarter. The decrease in general and administrative expenses was primarily due to severance and non-cash stock-based compensation costs related to the termination of CohBar’s former CEO in the prior year period and a decrease in recruiting fees, partially offset by an increase in payroll related accruals, legal fees and D&O insurance premiums.

●Net Loss. For the three months ended December 31, 2019, net loss, which included $0.7 million of non-cash expenses, was $3.7 million, or $0.09 per basic and diluted share. For the three months ended December 31, 2018, net loss, which included $1.0 million of non-cash expenses, was $4.2 million, or $0.10 per basic and diluted share.

Fourth Quarter Investor Call and Slide Presentation:

Date: March 12, 2020
Time: 5:00 p.m. ET (2:00 p.m. PT)

Conference Audio

- Dial-in U.S. and Canada: (877) 451-6152
- Dial-in International: (201) 389-0879
- Conference ID No.: 13698823

Slide Presentation

-Go to www.webex.com, click on the ‘Join’ button and enter meeting number 925 797 732 and Password CWBR, or
-Go to www.cohbar.com and click on Q4 2019 Shareholder Presentation at top of homepage.

We kindly request that you please call into the conference audio and log into Webex approximately 10 minutes prior to the start time so that we can begin promptly.

An audio replay of the call will be available beginning at 8:00 p.m. Eastern Time on March 12, 2020, through 11:59 p.m. Eastern Time on April 2, 2020. To access the recording please dial (844) 512-2921 in the U.S. and Canada, or (412) 317-6671 internationally, and reference Conference ID# 13698823. The audio recording along with the slide presentation will also be available at www.cohbar.com during the same period.

On March 12, 2020 Thermo Fisher Scientific reported it has signed an agreement with Janssen Biotech, Inc., one of the Janssen Pharmaceutical Companies of Johnson & Johnson, to co-develop a companion diagnostic (CDx) in oncology (Press release, Thermo Fisher Scientific, MAR 12, 2020, View Source [SID1234555504]). The CDx will support clinical trial enrollment globally.

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Under the agreement, Thermo Fisher Scientific will collaborate with Janssen Research & Development, LLC scientists to validate multiple biomarkers for use with Thermo Fisher’s Oncomine Dx Target Test, which will be used to identify variant-positive patients for enrollment into clinical trials focused on non-small cell lung cancer (NSCLC). Additional indications in oncology may follow as part of the agreement.

Oncomine Dx Target Test is a next-generation sequencing (NGS) assay that contains 46 cancer-related biomarkers and a workflow that features a fast turnaround time and the lowest sample requirements on the market for detection of both DNA and RNA variants.

NGS is an established method of identifying gene variants at the center of several clinical trials or which are targeted by on-market and emerging therapies for cancer. Since its approval by the U.S. Food and Drug Administration in 2017, Oncomine Dx Target Test has been the focus of multiple drug development and clinical trial support agreements between Thermo Fisher and international pharmaceutical companies.

"The ability of the Oncomine Dx Target Test to rapidly detect variants of interest from very small quantities of DNA or RNA samples makes this technology ideally suited to support development programs requiring an NGS-based workflow that delivers actionable insights consistently," said Peter Silvester, senior vice president and president of Life Sciences Solutions at Thermo Fisher Scientific. "We are confident that this approach to patient stratification helps expedite drug development initiatives which ultimately are designed to promote better health outcomes through targeted therapies."

On March 12, 2020 Galmed Pharmaceuticals Ltd. (Nasdaq: GLMD) ("Galmed" or the "Company"), a clinical-stage biopharmaceutical company focused on the development of Aramchol, a liver targeted, oral, SCD1 modulator, currently in a Phase 3 clinical trial for the treatment of nonalcoholic steatohepatitis (NASH) and fibrosis provides reported financial results for the three and twelve months ended December 31, 2019 (Press release, Galmed Medical Research, MAR 12, 2020, View Source [SID1234555521]). The Company will host a conference call and webcast at 08:30 ET today.

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Financial Summary – Full Year 2019 vs. Full Year 2018; 4Q19 vs. 4Q18:

For the three and twelve months ended December 31, 2019, the Company recorded a net loss of $8.3 and $20.5 million or $0.39 and $0.97 per share, respectively, compared with a net loss of $3.7 million and $9.9 million, or $0.18 and $0.54 per share, for the three and twelve months ended December 31, 2018.

Research and development expenses were $18.2 million for the twelve months ended December 31, 2019, compared with $8.3 million for the twelve months ended December 31, 2018. For the three months ended December 31, 2019, research and development expenses totaled $7.4 million, which compares with $2.7 million for the same period in 2018. The increase during the three and twelve months is mainly due to the preparation and initiation of the ARMOR study.

The Company incurred general and administrative expenses of $4.2 million for the twelve months ended December 31, 2019, compared with $4.4 million for the twelve months ended December 31, 2018. For the three months ended December 31, 2018, general and administrative expenses totaled $1.3 million, which compares with $1.5 million for the same period in 2018. The decrease primarily resulted from a decrease in salaries and benefits expenses of approximately $0.5 million due to lower year-end bonuses.

During the three and twelve months ended December 31, 2019, the Company recognized a net financial income of $0.3 million and $1.9 million, respectively, compared with $0.5 and $0.9 million, respectively, during 2018. The increase during the twelve months ended December 31, 2019 is mainly due to an increase in interest income from marketable debt securities and short-term deposits, as compared to such income in 2018.

Cash and cash equivalents, restricted cash, short-term deposits and marketable debt securities totaled $75.6 million as of December 31, 2019, compared with $90.2 million as of December 31, 2018. The decrease is mainly attributable to our $14.9 million negative cash flow from operations during the twelve months ended December 31, 2019.
Conference Call & Webcast:

Thursday, March 12th @ 8:30am Eastern Time.

Toll Free:

1-877-425-9470

Toll/International:

1-201-389-0878

Israel Toll Free:

1-809-406-247

Conference ID:

13699345

Webcast:

View Source

Replay Dial-In Numbers

Toll Free:

1-844-512-2921

Toll/International:

1-412-317-6671

Replay Pin Number:

13699345

Replay Start:

Thursday, March 12, 2020, 11:30 AM ET

Replay Expiry:

Thursday, March 26, 2020, 11:59 PM ET

About Aramchol and Non-alcoholic Steatohepatitis (NASH)
Aramchol (arachidyl amido cholanoic acid) is a novel fatty acid bile acid conjugate, inducing beneficial modulation of intra-hepatic lipid metabolism. Aramchol’s ability to modulate hepatic lipid metabolism was discovered and validated in animal models, demonstrating downregulation of the three key pathologies of NASH: steatosis, inflammation and fibrosis. The effect of Aramchol on fibrosis is mediated by downregulation of steatosis and directly on human collagen producing cells. Aramchol has been granted Fast Track designation status by the FDA for the treatment of NASH.

NASH is an emerging world crisis impacting an estimated 3% to 5% of the U.S. population and an estimated 2% to 4% globally. It is the fastest growing cause of liver cancer and liver transplant in the U.S. due to the rise in obesity. NASH is the progressive form of non-alcoholic fatty liver disease that can lead to cardiovascular disease, cirrhosis and liver-related mortality.