On May 6, 2021, ORIC Pharmaceuticals, Inc. (the "Company") reported that it entered into an Open Market Sale AgreementSM (the "Sales Agreement") with Jefferies LLC as the Company’s sales agent (the "Agent"), pursuant to which the Company may offer and sell from time to time through the Agent up to $150 million of shares (the "Shares") of the Company’s common stock, par value $0.0001 per share ("Common Stock"), in such share amounts as the Company may specify by notice to the Agent, in accordance with the terms and conditions set forth in the Sales Agreement (Filing, 8-K, ORIC Pharmaceuticals, MAY 6, 2021, View Source [SID1234579369]).

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Sales, if any, of the Shares pursuant to the Sales Agreement may be made in negotiated transactions or transactions that are deemed to be an "at the market offering" as defined in Rule 415(a)(4) under the Securities Act of 1933, as amended (the "Securities Act"), including sales made directly on The Nasdaq Stock Market. Under the Sales Agreement, the Company will set the parameters for the sale of shares, including the number of shares to be issued, the time period during which sales are requested to be made, limitation on the number of shares that may be sold in any one trading day and any minimum price below which sales may not be made. The Company is not obligated to sell any Shares under the Sales Agreement.

The Shares will be offered and sold pursuant to the Company’s shelf registration statement on Form S-3 ASR which was automatically effective upon filing with the Securities and Exchange Commission (the "Commission") on May 6, 2021. The Company filed a prospectus supplement, dated May 6, 2021, with the Commission in connection with the offer and sale of the Shares. The Company may terminate the Sales Agreement upon written notice to the Agent for any reason or by the Agent upon written notice to us for any reason or at any time under certain circumstances, including but not limited to the occurrence of a material adverse change in the Company.

The Sales Agreement contains customary representations, warranties and agreements by us, and indemnification rights and obligations of the parties. The Sales Agreement provides that the Agent will be entitled to compensation for its services at a commission rate of up to 3.0% of the gross sales price per share of all shares sold through the Agent under the Sales Agreement. Under the terms of Sales Agreement, the Company agreed to indemnify the Agent against certain specified types of liabilities, including liabilities under the Securities Act, to contribute to payments the Agent may be required to make in respect of these liabilities, and to reimburse the Agent for certain expenses. In the ordinary course of business, the Agent or its respective affiliates from time to time have provided and may in the future provide various investment banking, commercial banking and financial advisory services to the company and/or its affiliates, for which it has received or may receive customary compensation.

The Company intends to use the net proceeds from the sale, if any, of the securities offered in the offering, together with the Company’s existing cash, cash equivalents and short-term investments, to fund the development of ORIC-101, to fund the development of ORIC-533, to fund the development of ORIC-944, to fund the development of ORIC-114, to fund other research and development activities, including the potential acquisition of and drug development activities related to new programs, as well as for working capital and other general corporate purposes. The Company does not have agreements or commitments for any specific acquisitions or strategic transactions at this time.

The above summary of the Sales Agreement does not purport to be complete and is qualified in its entirety by reference to the Sales Agreement, a copy which is attached as Exhibit 1.1 to this Current Report on Form 8-K and incorporated herein by reference. The legal opinion of Wilson Sonsini Goodrich & Rosati, Professional Corporation relating to the shares of Common Stock being offered pursuant to the Sales Agreement is filed as Exhibit 5.1 to this Current Report on Form 8-K.

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 [SID1234579368]).

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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.

On May 6, 2021 Mirati Therapeutics, Inc. (NASDAQ: MRTX), a clinical-stage targeted oncology company, reported financial results for the first quarter of 2021 and recent corporate updates (Press release, Mirati, MAY 6, 2021, View Source [SID1234579367]).

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"We are pleased to see the significant progress across our clinical pipeline, including sitravatinib and our novel KRASG12C inhibitor, adagrasib. We initiated several potentially registration-enabling studies evaluating adagrasib in lung and colorectal cancers, as monotherapy and in combination with other therapies," said Charles M. Baum, M.D., Ph.D., president and chief executive officer, Mirati Therapeutics, Inc. "We are excited to submit our first NDA with adagrasib in the second half of this year for patients with non-small cell lung cancer who have a KRASG12C mutation."

Baum added, "Mirati continues to advance an innovative pipeline of drug candidates. The company expects to file IND applications for two potentially first-in-class therapies – our KRASG12D inhibitor, MRTX1133, in 2022, and a synthetic lethal MTA cooperative PRMT5 inhibitor, in the first half of 2022."

Pipeline Updates

Adagrasib

Initiated two randomized registration-enabling Phase 3 trials, KRYSTAL-10 and KRYSTAL-12, evaluating adagrasib with cetuximab (ERBITUX)1 versus chemotherapy in patients with second-line colorectal cancer (CRC), and a confirmatory trial of adagrasib versus docetaxel in patients with previously treated non-small cell lung cancer (NSCLC), respectively.
Initiated a potentially registration-enabling Phase 2 cohort in the KRYSTAL-01 study evaluating adagrasib as a monotherapy in patients with first-line NSCLC who have an STK11/KRASG12C co-mutation.
Initiated a potentially registration-enabling Phase 2 cohort in the KRYSTAL-01 study evaluating adagrasib as a monotherapy in patients with CRC who have received three or more lines of therapy.
The Company expects to share updated monotherapy data in the second half of 2021 from the registration-enabling Phase 1/2 KRYSTAL-01 study, evaluating adagrasib as a monotherapy in NSCLC, and Phase 1 data in CRC.
The Company expects to share initial proof-of-concept combination data in the second half of 2021 from the Phase 1/2 KRYSTAL-01 study, evaluating adagrasib with pembrolizumab (KEYTRUDA)2 in NSCLC, and with cetuximab (ERBITUX) in CRC.
The Company expects to provide an update in the first half of 2022 on additional combination data in NSCLC, including adagrasib plus a SHP2 inhibitor.
Sitravatinib

Continued to enroll patients in the Phase 3 SAPPHIRE clinical trial evaluating sitravatinib plus nivolumab (OPDIVO)3 in second or third line non-squamous NSCLC.
Preclinical

Continued to evaluate the optimal formulation and drug delivery approach for the potential first-in-class investigational KRASG12D inhibitor, MRTX1133, to improve the therapeutic exposure for patients with KRASG12D mutations. The Company expects to file an IND application for MRTX1133 in 2022.
Announced initial preclinical results evaluating the Company’s investigational synthetic lethal PRMT5 inhibitor program in methylthioadenosine phosphorylase (MTAP)-deleted cancer models at the 2021 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting. The Company expects to file an IND application for this program in the first half of 2022. (View Release)
Corporate Updates

Announced the Company will contribute a $4 million grant to Stand Up To Cancer to develop new approaches to treat patients with KRAS mutant cancers. (View Release)
Announced Mirati Board of Directors elected a new independent director, Ms. Shalini Sharp. (View Release)
Ended the first quarter with approximately $1.3 billion in cash, cash equivalents, and short-term investments.
Financial Results for the First Quarter 2021

Research and development expenses for the first quarter of 2021 were $104.1 million, compared to $71.7 million for the same period in 2020. The increase in research and development expenses is primarily due to an increase in expense associated with the development of adagrasib, an increase in preclinical and early discovery activities, as well as an increase in salaries and other employee-related expense, which includes an increase in share-based compensation expense. The Company recognized research and development-related share-based compensation expenses of $14.5 million during the first quarter of 2021, compared to $11.8 million for the same period in 2020.
General and administrative expenses for the first quarter of 2021 were $28.4 million, compared to $18.0 million for the same period in 2020. The increase is primarily due to an increase in sponsorship agreements expense, professional service expense, and salaries and other employee-related expenses. The Company recognized general and administrative-related share-based compensation expenses of $10.2 million in the first quarter of 2021, compared to $9.7 million for the same period in 2020.
Net loss for the first quarter of 2021 was $135.7 million, or $2.67 per share basic and diluted, compared to a net loss of $86.7 million, or $2.02 per share basic and diluted for the same period in 2020.
Cash, cash equivalents, and short-term investments were $1.3 billion at March 31, 2021.

On May 6, 2021 Certara, Inc. (Nasdaq: CERT), a global leader in biosimulation, reported its financial results for the first quarter of fiscal year 2021 (Press release, Certara, MAY 6, 2021, View Source [SID1234579366]).

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Highlights:
Revenue was $66.7 million, representing growth of 16% over the first quarter of 2020.
Net income was $1.1 million, compared to a net income of $1.0 million in the first quarter of 2020.
Adjusted EBITDA was $23.9 million, representing growth of 20% over the first quarter of 2020.
2021 guidance range was updated to $277 million – $285 million of revenue, $100 million – $102 million of adjusted EBITDA, and effective annual tax rate was lowered to 40% – 45%.
"Certara realized a successful start to the year, which reflects increased adoption of our proprietary end-to-end platform globally. As the COVID-19 pandemic continues to impact lives worldwide, I want to thank our Certara team for their dedication and tireless efforts to advance the use of biosimulation and for delivering another record quarter of revenue – which is our first full quarter as a public company. With a broad and diverse customer base and robust demand for our innovative offerings, we continue to be well-positioned for sustained growth," said William F. Feehery, chief executive officer.

First Quarter 2021 Results
"In the first quarter, we delivered double-digit growth in revenue and profitability by executing on our customer commitments. With first quarter bookings growth of 34% year-over-year, we have solid momentum towards achieving our business and financial goals for the year," said Andrew Schemick, chief financial officer.

Total revenue for the first quarter of 2021 was $66.7 million, representing year-over-year growth of 16%. The revenue growth was driven primarily by technology enabled services and software licenses and subscriptions.

Total cost of revenue for the first quarter of 2021 was $26.0 million, an increase from $22.2 million in the first quarter of 2020, primarily due to a $2.3 million increase in employee related costs and a $0.8 million increase in stock-based compensation costs, partially offset by decreases in travel related cost and retention expenses.

Total operating expenses for the first quarter of 2021 were $35.1 million, an increase from $27.3 million in the first quarter of 2020, primarily due to a $3.8 million increase in stock-based compensation expense, and a $1.4 million increase in employee related costs. The remaining increases were due to increases in secondary offering costs, acquisition related costs and D&O insurance.

Net income for the first quarter of 2021 was $1.1 million, compared to a net income of $1.0 million in the first quarter of 2020. Income from operations decreased $2.4 million due to higher stock-based compensation expenses and acquisition and transaction related expenses. The decrease in income from operations was offset by lower interest expense. Diluted Earnings Per Share for the first quarter 2021 and 2020 were $0.01.

Adjusted EBITDA for the first quarter of 2021 was $23.9 million compared to $19.9 million for the first quarter of 2020, representing 20% growth. See note (1) in the section A Note on Non-GAAP Financial Measures, below, for more information on Adjusted EBITDA.

Adjusted Net Income for the first quarter of 2021 was $9.4 million compared to $2.1 million for the first quarter of 2020. Adjusted Diluted Earnings Per Share for the first quarter 2021 was $0.06 compared to $0.02 for the first quarter of 2020. See note (2) in the section A Note on Non-GAAP Financial Measures, below, for more information on Adjusted Net Income and Adjusted Diluted Earnings Per Share.

2021 Financial Outlook
Certara is updating its previously reported guidance for full year 2021 by raising the low end the range for revenue and Adjusted EBITDA and lowering the range of its effective annual tax rate. We expect the following:

Full year 2021 revenue to be in the range of $277 million to $285 million;

Full year 2021 Adjusted EBITDA to be in the range of $100 million to $102 million;

Full year 2021 Adjusted Diluted Earnings Per Share is expected to be in the range of $0.20 to $0.24;

Fully diluted shares for 2021 will be 153 million to 155 million; and

Effective annual tax rate for 2021 will be in the range of 40% to 45%.

Webcast and Conference Call Details
Certara will host a conference call today, May 6, 2021, at 5:00 p.m. ET to discuss its first quarter 2021 financial results. The dial-in numbers are (833) 360-0946 for domestic callers or (914) 987-7661 for international callers, followed by Conference ID: 9802129. A live webcast of the conference call will be available on the "Investors" section of the Company’s website at View Source The webcast will be archived on the website following the completion of the call for approximately one year.

On May 6, 2021 Nektar Therapeutics (Nasdaq: NKTR) reported financial results for the first quarter ended March 31, 2021 (Press release, Nektar Therapeutics, MAY 6, 2021, View Source [SID1234579365]).

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Cash and investments in marketable securities at March 31, 2021 were approximately $1.1 billion as compared to $1.2 billion at December 31, 2020.

"We continue to build momentum with our clinical pipeline of novel cytokine therapeutics," said Howard W. Robin, President and CEO of Nektar. "We have a robust development program for bempegaldesleukin focused on pursuing large front-line and adjuvant tumor settings. Our five registrational studies underway in melanoma, renal cell carcinoma, and bladder cancer are progressing as planned. In February, we added a sixth registrational study for bempegaldesleukin plus pembrolizumab in head and neck cancer, which we expect to initiate later this year. In addition, we remain on track to report the first data for our PROPEL study evaluating bempegaldesleukin plus pembrolizumab in patients with metastatic non-small cell lung cancer in the second half of 2021."

"For our second cytokine program in oncology, NKTR-255, our initial efforts include two Phase 1 clinical studies in combination with ADCC antibodies, one in hematological malignancies and one in solid tumors, and we look forward to sharing data from these studies in Q4 of this year," continued Mr. Robin. "Finally, as part of the broad development program for NKTR-358, our T regulatory cell IL-2 agent, our partner Eli Lilly is conducting Phase 2 studies in both lupus and ulcerative colitis and plans to initiate additional Phase 2 studies in two different immune-mediated diseases over the next 9-12 months."

Summary of Financial Results

Revenue in the first quarter of 2021 was $23.6 million as compared to $50.6 million in the first quarter of 2020. The decrease was due primarily to the recognition of the $25.0 million milestone payment from Bristol-Myers Squibb related to the initiation of the registrational trial of bempegaldesleukin plus Opdivo in muscle-invasive bladder cancer in the first quarter of 2020.

Total operating costs and expenses in the first quarter of 2021 were $133.0 million as compared to $184.2 million in the first quarter of 2020. Operating costs and expenses decreased primarily as a result of $45.2 million in impairment charges in the first quarter of 2020 resulting from the discontinuation of the NKTR-181 program and a decrease in R&D expense.

R&D expense in the first quarter of 2021 was $95.6 million as compared to $109.0 million for the first quarter of 2020. R&D expense decreased primarily due to a decrease in manufacturing costs for bempegaldesleukin.

G&A expense was $31.7 million in the first quarter of 2021 and $26.2 million in the first quarter of 2020. G&A expense increased primarily due to an increase in pre-commercial costs for bempegaldesleukin.

Net loss for the first quarter of 2021 was $123.0 million or $0.68 basic and diluted loss per share as compared to a net loss of $138.7 million or $0.78 basic and diluted loss per share in the first quarter of 2020.

First Quarter 2021 and Recent Business Highlights:

●In February 2021, Nektar announced a clinical trial collaboration and supply agreement with Merck for a Phase 2/3 study of bempegaldesleukin, Nektar’s investigational IL-2 pathway agent, in combination with Merck’s KEYTRUDA (pembrolizumab) for first-line treatment of patients with metastatic or unresectable recurrent squamous cell carcinoma of the head and neck (SCCHN) whose tumors express PD-L1. The study is planned to start in the second half of 2021.

●In February 2021, Nektar announced a financing and co-development collaboration with SFJ Pharmaceuticals for the development of bempegaldesleukin plus pembrolizumab in SCCHN. SFJ has agreed to fund up to $150 million to support the planned Phase 2/3 study and manage clinical trial operations for the study. In return, Nektar agrees to pay SFJ success-based annual milestone payments over a period of seven to eight years which are contingent upon receipt of certain U.S. regulatory approvals for specified indications for bempegaldesleukin, and will begin following completion of the SCCHN study, which is projected to be completed in 2024

Conference Call to Discuss First Quarter 2021 Financial Results

Nektar management will host a conference call to review the results beginning at 5:00 p.m. Eastern Time/2:00 p.m. Pacific Time, Thursday, May 6, 2021.

This press release and a live audio-only Webcast of the conference call can be accessed through a link that is posted on the home page and Investors section of the Nektar website: View Source The web broadcast of the conference call will be available for replay through June 6, 2021.

To access the conference call, follow these instructions:

In the event that any non-GAAP financial measure is discussed on the conference call that is not described in the press release, or explained on the conference call, related information will be made available on the Investors page at the Nektar website as soon as practical after the conclusion of the conference call