On May 6, 2021 Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) reported financial results for the first quarter of 2021 and provided a business update (Press release, Regeneron, MAY 6, 2021, View Source [SID1234579371]).

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"Regeneron had a strong first quarter highlighting our continued evolution into a company with multiple durable product lines helping people with a range of serious diseases including COVID-19," said Leonard S. Schleifer, M.D., Ph.D., President and Chief Executive Officer of Regeneron. "We recently reported positive Phase 3 results for REGEN-COV in both the COVID-19 outpatient treatment and prevention settings and are working with national and state authorities to improve access. We expect continued growth with EYLEA in retinal diseases, as well as with Dupixent through further penetration in existing indications and a broad Phase 3 development program. In oncology, we are in the early days of launching Libtayo for advanced basal cell carcinoma and non-small cell lung cancer and recently announced positive pivotal data in cervical cancer with regulatory submissions planned for later this year."

"Our business is off to a strong start in 2021 with double-digit top- and bottom-line growth," said Robert E. Landry, Executive Vice President, Finance and Chief Financial Officer of Regeneron. "Our financial strength and solid execution across the business continue to position the Company for sustainable long-term growth."

Business Highlights

Key Pipeline Progress

Regeneron has approximately 30 product candidates in clinical development, including six marketed products for which it is investigating additional indications. Updates from the clinical pipeline include:

EYLEA (aflibercept) Injection

In March 2021, JAMA Ophthalmology announced initial results from the National Institutes of Health-sponsored Protocol W trial evaluating EYLEA in patients with moderate to severe non-proliferative diabetic retinopathy (NPDR). The two-year data confirmed results from the Company-sponsored PANORAMA trial and demonstrated that EYLEA significantly reduced the risk of developing vision-threatening complications with an every-16-weeks dosing regimen. The Company plans to submit a supplemental Biologics License Application (sBLA) for an every-16-weeks dosing regimen in patients with NPDR later this year.
Dupixent (dupilumab)

The U.S. Food and Drug Administration (FDA) accepted for review, with a target action date of October 21, 2021, the sBLA for Dupixent for children aged 6 to 11 years with moderate-to-severe asthma. A regulatory application for Dupixent for children aged 6 to 11 years with severe asthma was also submitted in the European Union (EU).
REGEN-COVTM (casirivimab with imdevimab), a dual antibody cocktail to SARS-CoV-2 virus

In March 2021, the Company announced positive top-line results from the Phase 3 treatment trial in high-risk COVID-19 outpatients. The trial met its primary endpoint, showing that REGEN-COV significantly reduced the risk of hospitalization or death by approximately 70% with both REGEN-COV doses (1,200 mg and 2,400 mg) compared to placebo. The trial also met key secondary endpoints, including the ability to reduce symptom duration. Based on these results, the Company submitted a request to the FDA to update the Emergency Use Authorization (EUA) to the lower 1,200 mg dose.
In April 2021, the National Institutes of Health (NIH) COVID-19 Treatment Guidelines were updated to strongly recommended that REGEN-COV be used in non-hospitalized COVID-19 patients at high risk of clinical progression.
In April 2021, the Company announced positive results from the Phase 3 COVID-19 prevention trial in uninfected household contacts of SARS-CoV-2 infected individuals. The trial met its primary and key secondary endpoints, showing that REGEN-COV 1,200 mg administered subcutaneously reduced the risk of symptomatic infections by 81%. The Company has shared this data with the FDA and requested that the EUA be expanded to include COVID-19 prevention for appropriate populations.
In April 2021, the Company also announced positive data from a Phase 3 treatment trial in recently infected asymptomatic COVID-19 patients. The trial met all primary and key secondary endpoints, and demonstrated that the 1,200 mg subcutaneous injection of REGEN-COV reduced the risk of progressing to symptomatic COVID-19 by 31%, and by 76% after the third day.
In January 2021, the Company announced a second agreement with the U.S. government to manufacture and deliver REGEN-COV. The U.S. government has agreed to acquire up to 1.25 million additional doses at the lowest treatment dose authorized or approved by the FDA for the indication authorized under the EUA, resulting in payments to the Company of up to $2.625 billion in the aggregate. The Company anticipates being able to provide at least 1 million doses by June 30, 2021 if the EUA is updated to the lower 1,200 mg dose. The U.S. government is obligated to purchase all filled and finished doses of drug product delivered by June 30, 2021, and may accept additional doses through September 30, 2021 at its discretion. A number of factors may impact the quantity of filled and finished product supplied by June 30, 2021, including manufacturing considerations and authorized dose levels.
Libtayo (cemiplimab)

In February 2021, the FDA approved Libtayo for the first-line treatment of patients with advanced NSCLC.
In February 2021, the FDA also approved Libtayo for the treatment of metastatic or locally advanced BCC.
In March 2021, the Company and Sanofi announced positive results from the Phase 3 trial in cervical cancer, which was stopped early based on a recommendation by the Independent Data Monitoring Committee (IDMC). The results demonstrated an overall survival benefit compared to chemotherapy. Regulatory submissions are planned for later this year.
Evkeeza, an antibody to ANGPTL3

In February 2021, the FDA approved Evkeeza for the treatment of adults and adolescents with HoFH.
Bispecific Antibodies

The Company retained the exclusive rights to develop and commercialize two bispecific antibodies targeting BCMAxCD3 (REGN5458 and REGN5459) and a bispecific antibody targeting MUC16xCD3 (REGN4018) as Sanofi did not exercise its options to license rights to these product candidates under the companies’ immuno-oncology collaboration. REGN5458 and REGN5459 are in clinical development for multiple myeloma, and REGN4018 is being studied in ovarian cancer.
REGN1908-1909, a multi-antibody therapy to Fel d 1

In February 2021, the Company announced that the Phase 2 study in cat allergic patients with mild asthma met its primary and key secondary endpoints. The Company plans to initiate a Phase 3 study in cat allergic asthmatics later this year.
First Quarter 2021 Financial Results

Revenues

Total revenues increased by 38% to $2.529 billion in the first quarter of 2021, compared to $1.828 billion in the first quarter of 2020. Total revenues excluding REGEN-COV increased by 20% to $2.200 billion in the first quarter of 2021, compared to the first quarter of 2020.

Net product sales recorded by the Company consist of the following:

Total revenues also include collaboration revenues(2) of $754 million in the first quarter of 2021, compared to $528 million in the first quarter of 2020. Sanofi collaboration revenue increased primarily due to the Company’s share of profits from commercialization of antibodies, which were $261 million in the first quarter of 2021, compared to $171 million in the first quarter of 2020. The change in the Company’s share of profits from commercialization of antibodies was primarily driven by higher Dupixent profits. In the first quarter of 2021, the Company also recorded Roche collaboration revenue of $67 million in connection with the Company’s share of gross profits from sales of the casirivimab with imdevimab antibody cocktail (known as REGEN-COV in the United States).

Refer to Table 4 for a summary of collaboration revenue.

The higher GAAP and non-GAAP R&D expenses in the first quarter of 2021 were primarily due to costs incurred in connection with development activities related to REGEN-COV.
The increase in GAAP and non-GAAP SG&A expenses in the first quarter of 2021 was primarily due to an increase in product launch-related costs and higher headcount-related costs.
The increase in COGS in the first quarter of 2021 was primarily due to the recognition of manufacturing costs in connection with product sales of REGEN-COV in the United States, as well as Praluent in the United States (which were recorded by Sanofi prior to April 1, 2020).
Other operating (income) expense, net, includes recognition of a portion of amounts previously deferred in connection with up-front and development milestone payments, as applicable, received in connection with the Company’s collaborative arrangements.
Other Financial Information

GAAP other income (expense), net, includes the recognition of net gains on equity securities of $144 million in the first quarter of 2021, compared to net losses of $57 million in the first quarter of 2020.

In the first quarter of 2021, the Company’s GAAP effective tax rate was 11.0%, compared to 6.6% in the first quarter of 2020. The GAAP effective tax rate for the first quarter 2021 was positively impacted, compared to the U.S. federal statutory rate, primarily by the reversal of liabilities related to uncertain tax positions, stock-based compensation, income earned in foreign jurisdictions with tax rates lower than the U.S. federal statutory rate, and federal tax credits for research activities. In the first quarter of 2021, the non-GAAP effective tax rate was 10.5%, compared to 9.5% in the first quarter of 2020.

GAAP net income per diluted share was $10.09 in the first quarter of 2021, compared to GAAP net income per diluted share of $5.43 in the first quarter of 2020. Non-GAAP net income per diluted share was $9.89 in the first quarter of 2021, compared to non-GAAP net income per diluted share of $6.60 in the first quarter of 2020. A reconciliation of the Company’s GAAP to non-GAAP results is included in Table 3 of this press release.

In January 2021, the Company’s board of directors authorized a new share repurchase program to repurchase up to $1.5 billion of the Company’s common stock. Repurchases may be made from time to time at management’s discretion through a variety of methods. The program has no time limit and can be discontinued at any time. During the first quarter of 2021, the Company repurchased shares of common stock under the program, and recorded the cost of the shares received, or $323 million, as Treasury Stock. As of March 31, 2021, $1.177 billion remained available for share repurchases under the program.

Net cash provided by operating activities in the first quarter of 2021 was $669 million, compared to $698 million in the first quarter of 2020, resulting in $553 million in free cash flow for the first quarter of 2021, compared to $528 million for the first quarter of 2020.

2021 Financial Guidance(3)

The Company’s full year 2021 financial guidance consists of the following components:

Conference Call Information

Regeneron will host a conference call and simultaneous webcast to discuss its first quarter 2021 financial and operating results on Thursday, May 6, 2021, at 8:30 AM Eastern Time. To access this call, dial (888) 660-6127 (U.S.) or (973) 890-8355 (International), conference ID 7794757. A link to the webcast may be accessed from the "Investors and Media" page of Regeneron’s website at www.regeneron.com. A replay of the conference call and webcast will be archived on the Company’s website and will be available for at least 30 days.

On May 6, 2021 Regulus Therapeutics Inc. (Nasdaq: RGLS), a biopharmaceutical company focused on the discovery and development of innovative medicines targeting microRNAs (the "Company" or "Regulus"), reported that it will report financial results and highlights for the quarter ended March 31, 2021 on Thursday, May 13, 2021, after the U.S. financial markets close (Press release, Regulus, MAY 6, 2021, View Source [SID1234579370]).

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The Company will host a conference call and live audio webcast on Thursday, May 13, 2021 at 5:00 pm Eastern Daylight Time to report its first quarter 2021 financial results and provide a corporate update. To access the call, please dial (877) 257-8599 (domestic) or (970) 315-0459 (international) and refer to conference ID 6947037. To access the telephone replay of the call, dial (855) 859-2056 (domestic) or (404) 537-3406 (international), passcode ID 6947037. The webcast and telephone replay will be archived on the Company’s website at www.regulusrx.com following the call.

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.