On May 6, 2021 ViewRay, Inc. (Nasdaq: VRAY) (the "Company") reported financial results for the first quarter ended March 31, 2021 (Press release, ViewRay, MAY 6, 2021, View Source [SID1234579410]).

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First Quarter 2021 Highlights

Received seven new orders for MRIdian systems totaling $40.9 million, compared to four new orders totaling $22.6 million in the first quarter of 2020.
Total backlog increased to $264.3 million as of March 31, 2021, compared to $230.8 million as of March 31, 2020.
Total revenue of $15.5 million primarily from two revenue units, compared to $14.3 million primarily from three revenue units, including one system upgrade, in the first quarter of 2020.
Cash burn in the first quarter of 2021 was approximately $28 million, excluding the net proceeds from the January 2021 public offering, compared to approximately $36 million in the first quarter of 2020.
Cash and cash equivalents were $182.0 million as of March 31, 2021.
2021 Public Offering of Common Stock

As previously disclosed, in January 2021, the Company raised aggregate net proceeds of approximately $53.5 million after deducting the underwriting discounts, commissions, and estimated offering expenses via a public offering in which 11,856,500 shares of our common stock were issued and sold, including the full exercise of the underwriters’ option to purchase additional shares, at a price to the public of $4.85 per share.
"Our performance in the first quarter 2021 represents a solid step forward and progress on our mission to improve the paradigm of care for cancer patients globally," said Scott Drake, President and CEO. "Our clinical and innovation pipelines are driving commercial traction. We look forward to upcoming clinical trial data and advancements in our product pipeline which we expect will fuel future growth."

Financial Results

Total revenue for the three months ended March 31, 2021 was $15.5 million compared to $14.3 million for the same period last year.

Total gross profit for the three months ended March 31, 2021 was $0.3 million, compared to ($2.1) million for the same period last year.

Total operating expenses for the three months ended March 31, 2021 were $25.0 million, compared to $27.9 million for the same period last year.

Net loss for the three months ended March 31, 2021 was $26.7 million, or $0.17 per share, compared to $27.5 million, or $0.19 per share, for the same period last year.

ViewRay had total cash and cash equivalents of $182 million at March 31, 2021.

Financial Guidance

Due to the ongoing impact and uncertainty of the COVID-19 pandemic globally, the Company will not be providing financial guidance at this time.

Conference Call and Webcast

ViewRay will hold a conference call to discuss results on Thursday, May 6, 2021 at 4:30 p.m. ET / 1:30 p.m. PT. The dial-in numbers are (888) 771-4371 for domestic callers and (847) 585-4405 for international callers. The confirmation number is 50150605. A live webcast of the conference call will be available on the investor relations page of ViewRay’s corporate website at View Source

After the live webcast, a replay will remain available online on the investor relations page of ViewRay’s website, under "Financial Events and Webinars", for 14 days following the call. In addition, a telephonic replay of the call will be available until May 13, 2021. 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 8484107.

On May 6, 2021 Crinetics Pharmaceuticals, Inc. (Nasdaq: CRNX), a clinical stage pharmaceutical company focused on the discovery, development, and commercialization of novel therapeutics for rare endocrine diseases and endocrine-related tumors, reported financial results for the first quarter ended March 31, 2021 and provided a corporate update (Press release, Crinetics Pharmaceuticals, MAY 6, 2021, View Source [SID1234579457]).

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"In the first quarter we achieved key clinical and regulatory milestones across our pipeline," said Scott Struthers, Ph.D., Founder and Chief Executive Officer of Crinetics. "Based on our interactions with the FDA and other regulators, we developed a robust Phase 3 program for paltusotine that is designed to support its approval for all acromegaly patients who require pharmacotherapy, including both untreated patients and those switching from injected standard of care. This progress was complemented by the advancement of CRN04894 and CRN04777 into Phase 1 trials in healthy volunteers, which are designed to generate safety, pharmacokinetic, and biomarker data that could establish clinical proof of concept and provide important dose guidance information for subsequent trials in patients. Looking ahead, we are on track for a steady cadence of catalysts through the remainder of the year, including data from both of our Phase 1 trials and the initiation of a clinical study in patients with neuroendocrine tumors complicated by carcinoid syndrome."

First Quarter and Subsequent Highlights

Announced the design of the Phase 3 program for paltusotine in acromegaly. In March 2021, Crinetics announced plans to initiate two Phase 3 studies based on interactions with the U.S. Food and Drug Administration (FDA) and other regulators. The first of these studies, PATHFNDR-1, is a double-blind, placebo-controlled, nine-month clinical trial evaluating the safety and efficacy of paltusotine in acromegaly patients who are biochemically controlled (IGF-1 ≤ 1.0 × upper limit of normal [ULN]) and who are on stable doses of somatostatin receptor ligand monotherapy (octreotide LAR or lanreotide depot). The second study, PATHFNDR-2, is a double-blind, placebo-controlled, twelve-week trial in acromegaly patients with elevated IGF-1 levels who are medication naïve or who are not being treated with pharmacotherapy (untreated patients). If successful, Crinetics believes these trials could support registration of paltusotine in the United States and Europe for all acromegaly patients who require pharmacotherapy, including untreated patients and those switching from standard of care. The company initiated PATHFNDR-1 in April and expects to initiate PATHFNDR-2 in 2H 2021.
Showcased broad clinical-stage pipeline at ENDO 2021. In March 2021, Crinetics gave presentations on its three clinical programs at the Endocrine Society’s annual ENDO 2021 congress. Posters on the company’s acromegaly program included a summary of the previously announced ACROBAT Edge Phase 2 results, as well as details of the new tablet formulation of paltusotine. Presentations related to the company’s earlier stage clinical programs included a poster with preclinical data supporting the development of CRN04777 as a treatment for congenital hyperinsulinism (HI) and a live oral presentation with preclinical evidence supporting the further evaluation of CRN04894 in Cushing’s disease and congenital adrenal hyperplasia (CAH).
Advanced ACTH antagonist CRN04894 into a Phase 1 study designed to provide clinical proof of concept. In February 2021, Crinetics initiated a Phase 1 study of CRN04894, an investigational, oral, nonpeptide adrenocorticotropic hormone (ACTH) antagonist being developed for the treatment of diseases associated with excess ACTH such as Cushing’s disease and congenital adrenal hyperplasia (CAH). This study is designed to evaluate the safety and tolerability of CRN04894 in healthy volunteers, and to provide clinical proof-of-concept data by measuring the effect of CRN04894 on the suppression of endocrine biomarkers that are used as key endpoints in patient studies and reflect the ability of CRN04894 to block ACTH-stimulated adrenal function. This healthy volunteer trial is also expected to provide important information for dose selection and be predictive of efficacy in Cushing’s disease and CAH patients. Crinetics expects preliminary safety, pharmacokinetic, and endocrine biomarker data in mid-2021.
Advanced SST5 agonist CRN04777 into a Phase 1 study designed to provide clinical proof of concept. In February 2021, Crinetics initiated a Phase 1 study of CRN04777, an investigational, oral, nonpeptide somatostatin receptor type 5 (SST5) agonist. CRN04777 is being developed as a treatment for congenital HI, a rare genetic disease in which excess insulin secretion causes life-threatening hypoglycemia (low blood glucose). This study is designed to evaluate the safety and tolerability of CRN04777 in healthy volunteers and provide clinical proof-of-concept data by measuring both the ability of CRN04777 to inhibit glucose- and sulfonylurea-induced insulin secretion and the corresponding effects on blood glucose levels. These endocrine biomarkers are indicative of the ability of CRN04777 to prevent hypoglycemia and are expected to provide information for dose selection and be predictive of efficacy in patients with hyperinsulinism. Crinetics expects preliminary safety and pharmacological effect data in mid-2021.
Strengthened balance sheet with successful common stock offering. In April 2021, Crinetics completed an underwritten follow-on offering and raised net proceeds of approximately $72.5 million.
First Quarter 2021 Financial Results

Research and development expenses were $17.6 million for the three months ended March 31, 2021, compared to $13.9 million for the same period in 2020. The increase was primarily attributable to additional personnel costs and clinical development and manufacturing activities for paltusotine, CRN04894, and CRN04777 as well as the company’s other preclinical programs.
General and administrative expenses were $5.3 million for the three months ended March 31, 2021, compared to $4.0 million for the same period in 2020. The increase was primarily due to additional personnel costs to support the company’s growth.
Net loss for the three months ended March 31, 2021 was $22.9 million, compared to a net loss of $17.4 million for the three months ended March 31, 2020.
Unrestricted cash, cash equivalents and investments totaled $150.7 million as of March 31, 2021, compared to $170.9 million as of December 31, 2020. The cash balance at the end of March does not include the $72.5 million of net proceeds from the follow-on offering completed in April.
As of April 30, 2021, the company had 37,593,371 common shares outstanding.

Regeneron has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission .

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On May 6, 2021 Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) reported that the research collaboration by Chugai (Forerunner Pharma Research), Department of Allergy and Rheumatology at the University of Tokyo Hospital, and RIKEN on a functional genome database was published online in the U.S. scientific journal Cell on April 29, 2021 (Press release, Chugai, MAY 6, 2021, View Source [SID1234579314]).

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"Dynamic landscape of immune cell-specific gene regulation in immune-mediated diseases"

"Chugai’s innovation is generated by its own scientific and technological capabilities. For the maintenance and improvement of state-of-the-art sciences, open innovation including collaboration with academia is essential. I am very proud that one of these efforts to understand disease biology has obtained the world’s highest level of scientific appraisal through the publication in Cell," said Dr. Osamu Okuda, Chugai’s President and CEO. "TOP I 2030, our growth strategy announced in February, places open innovation as one of its key drivers. We will continue expanding our collaboration with external networks to create innovative new drugs."

This study constructed a large-scale functional genome database "ImmuNexUT" (Immune cell gene expression atlas from the University of Tokyo) that significantly outperforms previous reports in the number of cases of immune-mediated diseases, the variety of clinical cases, and the types of immune cells, and clarified the relationship between gene polymorphisms and gene expression levels in each cell type involved in the onset of various immune-mediated diseases. A total of 9,852 samples of 28 immune cells were obtained from 416 peripheral blood samples from 10 representative patients with immunological diseases and healthy individuals, and these samples were used to quantify gene expression and to analyze the association between gene expression and gene polymorphisms. As valuable data showing the genomic functions of Asians, this database is expected to be applied to genomic studies of various disease states involving immunity, leading to the elucidation of disease states and the identification of therapeutic target molecules and biomarkers for pharmaceuticals.

Chugai participated in this collaborative study with the purpose of elucidating the disease state of autoimmune and autoinflammatory diseases and creating therapies through an integrated understanding of immunology and functional genomics. In promoting research, Chugai’s research subsidiary Forerunner Pharma Research which terminated its operation in March 2021 made significant contributions to building ImmuNexUT through acquisition by utilizing its strong immunology research infrastructure with clinical samples.

Chugai, which aims at becoming a top innovator in the healthcare industry, will promote open innovation including collaboration with academia to contribute to patients around the world through innovative drugs.

On May 6, 2021 Ascendis Pharma A/S (Nasdaq: ASND), a biopharmaceutical company that utilizes its innovative TransCon technologies to address unmet medical needs, reported presentations featuring TransCon PTH at two upcoming medical conferences: the 48th annual meeting of the European Calcified Tissue Society (ECTS), taking place virtually May 6-8, 2021 and the 23rd European Congress of Endocrinology taking place virtually May 22-26, 2021 (Press release, Ascendis Pharma, MAY 6, 2021, View Source [SID1234579344]).

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"We are excited to share the 26-week open-label extension (OLE) data from our phase 2 PaTH Forward Trial in adult patients with hypoparathyroidism with the European medical community," said Mark Bach, M.D., Ph.D., Senior Vice President of Endocrine Medical Sciences at Ascendis Pharma.

"These data provide evidence indicating that TransCon PTH has the potential to be a first line therapy as a hormone replacement in patients with hypoparathyroidism. The study was selected for oral presentations by both ECTS and ECE meeting organizers which we think underscores the significance of these results," continued Dr. Bach.

ECTS 2021: Presentation Details

Oral Presentation
Title Date/Time
Week 26 Results from the PaTH Forward Open-Label Extension Trial Support TransCon PTH as a Potential Hormone Replacement Therapy for Patients with Hypoparathyroidism Plenary Oral Presentations 2: Novel Aspects of Osteoporosis and Treatments
May 7, 2021
16:30 – 17:30 CEST
e-ECE 2021: Presentation Details

Oral Presentation
Title Date/Time
TransCon PTH as a Potential Hormone Replacement Therapy for Patients with Hypoparathyroidism: PaTH Forward Open-Label Extension Trial Week 26 Results Oral Communications 6: Calcium and Bone
May 25, 2021
14:30 – 15:30 CEST
The posters will be available on the Ascendis website under Selected Publications in the Pipeline section: View Source If you are a healthcare provider who would like more information, please contact: [email protected].

About TransCon Technology

TransCon refers to "transient conjugation." The proprietary TransCon platform is an innovative technology to create new therapies that are designed to optimize therapeutic effect, including efficacy, safety and dosing frequency. TransCon molecules have three components: an unmodified parent drug, an inert carrier that protects it, and a linker that temporarily binds the two. When bound, the carrier inactivates and shields the parent drug from clearance. When injected into the body, physiologic conditions (e.g., pH and temperature) initiate the release of the active, unmodified parent drug in a predictable manner. Because the parent drug is unmodified, its original mode of action is expected to be maintained. TransCon technology can be applied broadly to a protein, peptide or small molecule in multiple therapeutic areas, and can be used systemically or locally.