On May 12, 2021 BioAtla, Inc. (Nasdaq: BCAB), a global clinical-stage biotechnology company focused on the development of Conditionally Active Biologic (CAB) antibody therapeutics, reported financial results for the first quarter of 2021 and provided an update on its business (Press release, BioAtla, MAY 12, 2021, View Source [SID1234579829]).

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"BioAtla is rapidly advancing potentially registration-enabling Phase 2 clinical trials for our two lead CAB product candidates. With strong financial resources, we are also broadening our development pipeline to include several additional ADC and bispecific CAB candidates," stated Jay M. Short, Ph.D., Chairman, Chief Executive Officer and co-founder of BioAtla, Inc. "Our clinical objectives in 2021 include providing Phase 2 interim data readouts by year-end for CAB-AXL-ADC and CAB-ROR2-ADC. Our Phase 1 trials for these product candidates demonstrated encouraging results in hard to treat cancer indications, particularly in patients with late-stage disease refractory to other lines of therapy," added Scott Smith, President of BioAtla.

Advancing clinical trials for lead candidates

BA3011
We are developing BA3011, CAB-AXL-ADC, a conditionally activated antibody drug conjugate targeting the receptor tyrosine kinase AXL, as a potential therapeutic for multiple solid tumor types, including soft tissue and bone sarcoma, non-small cell lung cancer (NSCLC) and ovarian cancer, with other potential indications in the future. On March 1, 2021 the Office of Orphan Drug Products (OOPD) at FDA granted Orphan Drug Designation to BA3011 for the treatment of soft tissue sarcoma. In Phase 1, five partial responses (PR) were observed, four in sarcoma patients and one in a PD-1 refractory NSCLC patient. These responses occured in stage IV refractory patients with high AXL tumor membrane expression and at our recommended phase 2 dose (RP2D). We have initiated a potentially registration-enabling Phase 2 clinical trial of BA3011 given as monotherapy or in combination with a PD-1 inhibitor in soft tissue and primary bone sarcoma patients 12 years and older that are high AXL tumor membrane expressors (AXL high), and a Phase 2 study in AXL high NSCLC patients that have previously progressed on PD-1/L1 or EGFR inhibitor therapy. We expect to submit Phase 1 results in sarcoma patients for presentation at the Connective Tissue Oncology Society (CTOS) 2021 Annual Meeting in November. Interim analyses in the sarcoma and NSCLC trials are anticipated this year. In addition, a multi-center investigator-initiated Phase 2 clinical trial for BA3011 in platinum-resistant ovarian cancer in combination with a PD-1 inhibitor is currently under review by Health Canada and is expected to commence in the first half of this year in Canada and the United States.

BA3021
BA3021, CAB-ROR2-ADC, is a CAB antibody drug conjugate directed against ROR2, a receptor tyrosine kinase that is overexpressed across many different solid tumors including lung, head and neck, melanoma and breast. We are developing BA3021 as a potential therapeutic for multiple solid tumor types, including NSCLC, melanoma, squamous cell cancer of the head and neck (SSCHN), and ovarian cancer. We completed a Phase 1 dose-escalation trial with BA3021 in which we observed one complete response (CR) and 3 PRs. The CR was observed in the only ROR2-positive melanoma patient enrolled in the trial. This stage IV melanoma patient had experienced prior therapy failures with nivolumab (PD-1 inhibitor), and with nivolumab in combination with ipilimumab (CTLA-4 inhibitor). A PR was observed in the only SSCHN patient enrolled in the study. This patient was ROR2 positive and was refractory to four lines of prior therapy including with cetuximab and with pembrolizumab. Additionally, PRs were observed in two stage IV ROR2-positive NSCLC patients, both of whom had failed prior PD-1 therapy. All responses occurred at exposure levels equivalent to the BA3021 RP2D. We believe BA3021 has broad potential as a cancer therapy for patients with advanced solid tumors that have previously progressed on a PD-1 inhibitor. We are presently enrolling a Phase 2 trial of BA3021 monotherapy or in combination with a PD-1 inhibitor in ROR2 high NSCLC and melanoma patients that have previously progressed on PD-1/L1 inhibitor. A Phase 2 study in ROR2 high SSCHN patients that have previously progressed on a PD-1/L1 inhibitor is anticipated to initiate in second half of 2021. A BA3021 in combination with a PD-1 inhibitor Phase 2 clinical trial for platinum-resistant ovarian cancer is also under review by Health Canada.

BA3071
BA3071, is a CAB anti-CTLA-4 antibody that is being developed as an immuno-oncology agent with the goal of delivering efficacy comparable to the approved anti-CTLA-4 antibody, ipilimumab, but with lower toxicities due to the CAB’s tumor microenvironment-restricted activation. In a global collaboration with BeiGene, we are developing BA3071 as a potential therapeutic for multiple solid tumor indications, including renal cell carcinoma, NSCLC, small cell lung cancer, hepatocellular carcinoma, melanoma, bladder cancer, gastric cancer and cervical cancer. BeiGene is responsible for all costs of development, manufacturing and commercialization globally. BioAtla is eligible to receive milestone payments and royalties on product sales upon regulatory approvals and commercialization by BeiGene. A Phase 1 dose-escalation trial of BA3071 as monotherapy and in combination with BeiGene’s anti-PD-1 antibody, tislelizumab, are planned to commence in 2021.

Plans to advance development of several bispecific CAB candidates
We have also leveraged our CAB technology to develop bispecific antibodies, which bind both a tumor-specific antigen and a T cell receptor (CD3) using CAB antigen-binding domains. With this design, bispecific antibodies can induce potent T cell responses against tumors expressing the tumor target antigen. We have shown in preclinical experiments that our CAB bispecific molecules meet or exceed the activity of conventional bispecifics and reduce systemic activation of potentially fatal immune responses. We advanced two CAB bispecific antibody product candidates, EpCAM/CD3 and B7-H3/CD3, into IND-enabling studies in the second half of 2020. We also are evaluating additional candidates including EGFR and Nectin-4 for CAB CD3 bispecific modalities. Nectin-4 is also progressing as a CAB ADC candidate. Overall, we are advancing multiple pre-clinical assets with the potential to submit up to four US INDs by the end of 2022 for our CAB bispecific or ADC molecules.

First quarter 2021 financial results
Cash and cash equivalents as of March 31, 2021 were $221.2 million. In July 2020, BioAtla completed a successful private placement offering with institutional investors, for net proceeds of approximately $68.2 million. In December 2020, we received net proceeds of approximately $198.4 million from our initial public offering. We expect current cash and cash equivalents will be sufficient to fund planned operations into 2023.

Research and development (R&D) expenses were $10.4 million for the quarter ended March 31, 2021 compared to $1.7 million for the same quarter in 2020. We expect our R&D expenses to increase substantially for the foreseeable future as we continue to invest in R&D activities to advance our product candidates, and our clinical programs and expand our product candidate pipeline.

General and administrative (G&A) expenses were $8.4 million for the quarter ended March 31, 2021 compared to $(0.5) million for the same quarter in 2020. We expect our G&A expenses to increase as a result of operating as a public company. In addition, we expect our intellectual property expenses to increase as we expand our intellectual property portfolio.

Net loss for the first quarter ended March 31, 2021 was $18.7 million compared to a net loss of $1.6 million for the same quarter in 2020.

On May 12, 2021 Labcorp (NYSE: LH) ("Labcorp") reported that it has priced its offering of $1,000,000,000 in senior notes. The offering consists of two tranches: $500,000,000 aggregate principal amount of 1.550% Senior Notes due 2026 (the "2026 Notes") and $500,000,000 aggregate principal amount of 2.700% Senior Notes due 2031 (the "2031 Notes" and, together with the 2026 Notes, the "Notes") (Press release, LabCorp, MAY 12, 2021, View Source [SID1234579854]). The Notes will bear interest from May 26, 2021, payable semi-annually on June 1 and December 1, commencing on December 1, 2021. The closing of the offering is expected to occur on May 26, 2021, subject to the satisfaction of customary closing conditions. The Notes will be senior unsecured obligations and will rank equally with Labcorp’s existing and future senior unsecured debt.

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Labcorp expects to use the net proceeds of the Notes offering to redeem, prior to maturity, its outstanding 3.20% Senior Notes due Feb. 1, 2022 and 3.75% Senior Notes due Aug. 23, 2022.

The joint book-running managers for the offering are BofA Securities, KeyBanc Capital Markets, and Wells Fargo Securities. The offering will be made pursuant to an effective shelf registration statement on Form S-3 (File No. 333-234633) filed with the Securities and Exchange Commission (the "SEC") on Nov. 12, 2019. A copy of the prospectus and related prospectus supplement may be obtained without charge from the SEC. Alternatively, a copy of the prospectus and related prospectus supplement may be obtained from BofA Securities by calling toll-free 1-800-294-1322, from KeyBanc Capital Markets by calling toll-free 1-866-227-6479, or from Wells Fargo Securities by calling toll-free 1-800-645-3751.

This press release does not constitute an offer to sell or a solicitation of an offer to buy the Notes or any other securities, nor shall there be any sale of these securities in any jurisdiction in which such an offer, solicitation, or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction. The offering of these securities may be made only by means of the prospectus supplement and the accompanying prospectus.

On May 12, 2021 Sysmex reported that (Press release, Sysmex, MAY 12, 2021, View Source [SID1234580139])

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1. Consolidated Results for the Year Ended March 31, 2021
(2) Financial condition
(3) Cash flows

2. Dividend

3. Financial Forecast for the Year Ending March 31, 2022

4. Other Information

(1) Changes in significant consolidated subsidiaries (which resulted in changes in scope of consolidation):
No (2) Changes in accounting policies and accounting estimates

1) Changes in accounting policies required by IFRS:

No 2) Other changes in accounting policies:

No 3) Changes in accounting estimates:

No (3) Number of outstanding stock (common stock)

1) Number of outstanding stock at the end of each fiscal period (including treasury stock): 209,443,232 shares as of Mar. 31, 2021; 209,266,432 shares as of Mar. 31, 2020 2) Number of treasury stock at the end of each fiscal period: 446,876 shares as of Mar. 31, 2021; 446,680 shares as of Mar. 31, 2020 3) Average number of outstanding stock for each period (cumulative): 208,905,283 shares for the year ended Mar. 31, 2021 208,755,623 shares for the year ended Mar. 31, 2020

1. Overview of operating performance

1) Operating performance during the year Future-related information contained in the text below is based on the judgement as of the end of the fiscal period under review. During the fiscal year ended March 31, 2021, economic activity in Japan was in dire straits as a result of the COVID-19 pandemic, which sharply reduced personal consumption and caused corporate earnings to deteriorate. Thereafter, the situation began to improve due to gradual increases in the level of socioeconomic activity and the results of various government policies.

However, this was followed by a resurgence in infections and state of emergency declarations, and the outlook remains unclear. Overseas, increasingly serious COVID-19 outbreaks have prompted major cities to impose lockdowns and regulations against going out, substantially hampering economic activity. Thereafter, various government-imposed financial measures are leading to gradual recovery. That said, with no end to the pandemic in sight, the outlook remains opaque. On the healthcare front, Japan’s medical and healthcare field is expected to remain robust due to an aging society and increasingly diverse health and medical needs, which will drive up demand. Also, the Japanese government is positioning this field as part of an economic growth strategy.

Looking overseas, in developed countries efforts are underway to raise the efficiency of healthcare as populations age. Meanwhile, in emerging markets economic development is prompting an increase in demand for healthcare and the need for healthcare quality and service enhancement. Furthermore, the rapid application of artificial intelligence (AI), information communication technology (ICT) and other leading-edge technologies to the healthcare field are expected to sustain future growth.

The global COVID-19 pandemic has also prompted considerations about healthcare systems and the potential for major changes in the healthcare environment itself. As a result, further opportunities for growth is anticipated. Against this backdrop, Sysmex continued to develop its product portfolio in the hematology field. We launched two automated hematology analyzers in Japan, the XR Series (a next-generation flagship model) and the XQ series (a compact three-part WBC differential model). We will continue with a global sales rollout after receiving regulatory approval in individual countries.

We aim to continue expanding our product portfolio in the hematology field to help optimize operations at testing laboratories based on the regional characteristics and facilities’ needs. In the hemostasis field, we launched CN-6500/CN-3500 automated blood coagulation analyzers in Japan, which offer enhanced efficiency and quality. We renewed our global alliance in hemostasis products with Siemens Healthcare Diagnostics Inc. including review of products and territories, to step up sales of our CN Series automated blood coagulation analyzer and we will continue to offer extensive solutions to customers in regions throughout the world. In the life science field, Sysmex had received health insurance coverage for its gene mutation analysis set for cancer genome profiling (OncoGuide NCC Oncopanel System), becoming the first such system in Japan to receive this coverage. We received approval for partial changes to our manufacturing and marketing approval for this system. it has become possible to detect mutations and copy number alterations of 124 genes, fusions of 13 genes, and microsatellite instability (MSI).

The system will thus provide more detailed genetic information to help doctors decide treatment strategies, including diagnosis and selection of anti-cancer drugs. Medicaroid Corporation, a joint venture between Sysmex and Kawasaki Heavy Industry, Ltd., received manufacturing and marketing approval for hinotori Surgical Robot System, the first made-in-Japan robotic-assisted surgery system. As the global general distributor, Sysmex commenced sales of hinotori to medical institutions in Japan, starting with urology departments. We are working with Medicaroid to obtain regulatory approval overseas, and will begin introducing the system in overseas markets, as well. To help stem the increase in COVID-19 infections, we introduced reagent that can be used in conjunction with HISCL-5000/HISCL-800 automated immunoassay systems to detect the presence of coronavirus antigens that cause COVID-19, as well as reagent that can help in detecting the risk of COVID-19 cases worsening. Sysmex remains committed to contributing toward the research and establishment of diagnosis/treatment methods for COVID-19 by way of diverse testing, including PCR tests, antigen tests, antibody tests and cytokine tests, as well as existing hematology-3-and coagulation tests.

On May 11, 2021 BriaCell Therapeutics Corp. (Nasdaq: BCTX, BCTXW) (TSX-V:BCT) ("BriaCell" or the "Company"), a clinical-stage biotechnology company specializing in targeted immunotherapies for advanced breast cancer, reported that Dr. William V. Williams, President & CEO of BriaCell, is scheduled to participate in the following virtual conferences (Press release, BriaCell Therapeutics, MAY 11, 2021, View Source [SID1234579657]):

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• Benzinga Global Small Cap Investor Conference: May 13-14, 2021
o Dr. Williams will deliver his corporate presentation at 12:20pm ET on May 13, 2021.
o Dr. Williams will also participate in a panel discussion titled "Investing Post COVID – Back to the Fundamentals" at 11:50am ET on May 13, 2021. The panel will discuss healthcare investing in the post COVID world.
o Investors may request one-on-one meetings with Dr. Williams.
o Investors may register for the conference here: View Source

• Q2 Investor Summit: May 17-18, 2021
o Dr. Williams will deliver his corporate presentation at 2:00pm ET on May 17, 2021.
o Investors may request one-on-one meetings with Dr. Williams.
o Investors may register for the conference here: View Source

• 2021 LD Micro Invitational Investor Conference: June 8-10, 2021
o Dr. Williams will deliver his corporate presentation at 12:00pm ET on June 9, 2021.
o Investors may request one-on-one meetings with Dr. Williams.
o Investors may register for the conference here: View Source

• MarketsandMarkets 4th Annual Next Gen Immuno-Oncology Virtual Congress-US Edition: June 28-30, 2021
o Dr. Williams will be speaking at the scientific conference at 11:30am ET on June 29, 2021.
o The topic is "Personalized, off-the-shelf cellular immunotherapy for cancer".
o A copy of the presentation will be posted here: View Source
o For additional information on the conference and the speaker, please visit:
View Source

Separately, BriaCell has recently appointed Miguel A. Lopez-Lago, Ph.D. as Senior Director, Research and Development. Since 2000, Dr. Lopez-Lago has been working as a cancer scientist at Memorial Sloan-Kettering Cancer Center, New York (MSKCC). Specifically, he has investigated various aspects of tumor biology, including the development of targeted therapies for Mesothelioma and the characterization of the biological mechanisms underlying cancer metastasis. More recently, Dr. Lopez-Lago has been interested in the study of the tumor immune-microenvironment and in the development of immunotherapies for thoracic cancers using chimeric antigen receptor (CAR) T cell technologies. Since 2013, Dr. Lopez-Lago has been working as Senior Research Scientist at MSKCC. Dr. Lopez-Lago received his Bachelor of Science in Bio-Sciences and his doctorate in Molecular Biology from Santiago of Compostela University, Spain.

On May 11, 2021 Aileron Therapeutics (NASDAQ:ALRN), a chemoprotection oncology company focused on fundamentally transforming the experience of chemotherapy for cancer patients, reported business highlights and financial results for the first quarter ended March 31, 2021 (Press release, Aileron Therapeutics, MAY 11, 2021, View Source [SID1234579672]).

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"We continue to work diligently to initiate our first randomized, double-blind, placebo-controlled clinical trial of ALRN-6924 as a novel therapeutic to protect non-small cell lung cancer (NSCLC) patients receiving first-line chemotherapy against various chemotherapy-induced toxicities. Approximately 50% of NSCLC patients have a p53 mutation, suggesting the broad potential impact of ALRN-6924 in this indication alone," said Manuel Aivado, M.D., Ph.D., President and Chief Executive Officer.

Dr. Aivado further commented, "Simultaneously, we are actively planning for the rapid advancement of ALRN-6924 into late-stage development for patients with p53-mutated NSCLC pending the outcome of the Phase 1b trial. Bolstered by our successful capital raises in the first quarter of 2021, we are making near-term strategic investments in CMC, p53 companion diagnostic development, and team scale-up which we expect will not only enable the future advancement of our NSCLC clinical program, but also will provide foundational support for future clinical programs of ALRN-6924 across multiple p53-mutated cancer indications."

Aileron is developing ALRN-6924 to selectively protect healthy cells in patients with cancers that harbor p53 mutations, which are present in over half of all cancer patients, to reduce or eliminate chemotherapy-induced side effects while not interfering with chemotherapy’s attack on cancer cells. This novel concept is known as chemoprotection. By reducing or eliminating multiple chemotherapy-induced side effects, ALRN-6924 may improve patients’ quality of life and help them better tolerate chemotherapy. Enhanced tolerability may result in fewer dose reductions or delays of chemotherapy and the potential for improved efficacy as a result. Given Aileron’s p53 biomarker approach, designed to ensure selective chemoprotection only in healthy cells, coupled with the high prevalence of p53-mutated cancers, the company’s strategy is to ultimately pursue a tumor-agnostic label for ALRN-6924 as a chemoprotective agent in p53-mutated cancers.

First Quarter 2021 Highlights and Recent Updates

Aileron to host upcoming KOL Fireside Chat, "Protecting Cancer Patients from Chemotherapy-Induced Toxicities – A New Paradigm". Moderated by Soumit Roy, Ph.D., Vice President, Healthcare Analyst with JonesTrading Institutional Services LLC, the event will include a discussion on the unmet need and potential for chemoprotection with Alan List, M.D. and Lodovico Balducci, M.D. Dr. List, who recently was appointed Chief Medical Officer of Precision Biosciences, is a renowned hematologist with extensive academic and clinical experience in the research and development of hematology and oncology products. Dr. List is also a member of Aileron’s Scientific Advisory Board. Dr. Balducci, a prominent geriatric oncologist, previously served as Senior Member of the Senior Adult Oncology Program and Medical Director of Affiliates and Referring Physician Relations at the Moffitt Cancer Center. Link here to register for the event, which will take place on Wednesday, May 26, 2021.
Abstract co-authored by Aileron and Foundation Medicine, Inc. to be presented at 2021 ASCO (Free ASCO Whitepaper) Annual Meeting. The abstract, titled, "Gene Sequencing of Serial Tumor Biopsies from a Large Cohort of Cancer Patients Shows Longitudinal Changes in TP53 Mutation Status Are Uncommon" (Abstract #3124), was accepted as a poster presentation at the meeting. Additional details will be announced upon ASCO (Free ASCO Whitepaper)’s online publication of this year’s abstracts later this month.
Announced enrollment expansion for upcoming Phase 1b clinical trial of ALRN-6924 in patients with advanced NSCLC. In February 2021, Aileron announced a 50% expansion of its enrollment target for its upcoming Phase 1b clinical trial of ALRN-6924 in patients with NSCLC undergoing chemotherapy. Aileron plans to enroll 60 patients with advanced p53-mutated NSCLC undergoing treatment with first-line carboplatin plus pemetrexed (with or without immune checkpoint inhibitors). Aileron anticipates this enrollment expansion will enable a more robust exploration of ALRN-6924 as a novel chemoprotective agent to prevent chemotherapy-induced toxicities in the NSCLC patient population and better position the company to rapidly advance ALRN-6924 into late-stage clinical development for NSCLC following the Phase 1b trial.

In the Phase 1b NSCLC trial, patients will be randomized 1:1 to receive either carboplatin/pemetrexed plus 0.3 mg/kg ALRN-6924 or carboplatin/pemetrexed plus placebo for at least four 21-day treatment cycles. Evaluations will include the proportion of treatment cycles free of severe hematological and other toxicities, transfusions and the use of growth factors, as well as the impact on quality of life. Aileron plans to initiate the NSCLC trial in the second quarter of 2021 and anticipates reporting early interim data at the end of 2021 and topline results in mid-2022.
During the first quarter, Aileron completed its Phase 1b evaluation of ALRN-6924 at the recommended phase 2 dose of 0.3 mg/kg in patients with SCLC receiving ALRN-6924 24-hours prior to topotecan and conducted preliminary evaluation of data from additional cohorts. These preliminary findings from 11 additional patients (n=7 patients receiving 0.3 mg/kg ALRN-6924 six hours before topotecan and n=4 patients receiving 0.2 mg/kg ALRN-6924 twenty-four hours before topotecan) were in line with data presented last October and with Aileron’s expectation that administering ALRN-6924 at 0.3mg/kg and 24 hours before topotecan remains the optimal dose and schedule in this patient population. Aileron expects to present results of the Phase 1b SCLC trial at a scientific conference in the second half of 2021.

Raised $55.7 million in aggregate proceeds from the sale of common stock during first quarter 2021, which based on Aileron’s current operating plan, is expected to provide funding into the second half of 2023 and approximately 12 months beyond the anticipated topline results from the NSCLC trial. In January 2021, Aileron completed a registered direct offering of common stock, for a purchase price of $1.10 per share, raising $33.1 million in aggregate net proceeds, after deducting placement agent fees and other offering expenses payable by Aileron. New fundamental and institutional investors, including Acorn Bioventures, BVF Partners, L.P., Maven Investment Partners and Grand Oaks Capital, participated in the offering, in addition to several existing Aileron investors, including Satter Medical Technology Partners and Lincoln Park Capital Fund, LLC. In addition to the registered direct offering, since January 1, 2021, Aileron sold an aggregate of 13,775,399 shares of its common stock for an average purchase price of $1.64 per share, for aggregate net proceeds of $22.6 million, after deducting fees and offering expenses, in "at the market" offerings and under its structured equity line with Lincoln Park Capital Fund, LLC.
Continuing healthy volunteer study to support long-term clinical development strategy for ALRN-6924. The ongoing study, initiated in November 2020, is designed to characterize the time to onset, magnitude, and duration of cell cycle arrest in human bone marrow relative to ALRN-6924 administration. Another goal of the study is to develop a universal dosing regimen for ALRN-6924 for use as a chemoprotection agent across a range of chemotherapies and p53-mutated tumor indications. Aileron expects to present results from the healthy volunteer study at a scientific conference in the second half of 2021.
First Quarter 2021 Financial Results

Cash Position: Cash, cash equivalents and investments at March 31, 2021 were $63.4 million, compared to $13.8 million at December 31, 2020. The company expects, based on its current operating plan, that its existing cash, cash equivalents and investments will fund operations into the second half of 2023.

Research and Development (R&D) Expenses: R&D expenses for the quarter ended March 31, 2021 were $4.3 million, compared to $4.1 million for the corresponding quarter in 2020. The increase of $0.2 million is primarily a result of increased spending on clinical development of ALRN-6924 in connection with the preparation for the upcoming Phase 1b clinical trial in patients with advanced NSCLC patients being treated with first-line chemotherapy of carboplatin and pemetrexed and is partially offset by the effect of cost savings measures implemented in 2020 resulting in decreased spending on employee, facility and other development expenses.

General and Administrative (G&A) Expenses: G&A expenses for the quarter ended March 31, 2021 were $2.7 million, compared to $2.8 million for the corresponding quarter in 2020. The decrease in general and administrative expense is the result of lower headcount and facility costs during the three months ended March 31, 2021 as a result of cost savings measures as compared to the three months ended March 31, 2020 and is partially offset by increased spending on professional services.

Net Loss: Net loss for the quarter ended March 31, 2021 was $7.0 million, compared to $6.7 million for the corresponding quarter in 2020. The basic and diluted net loss per share for the first quarter of 2021 was $0.08 compared to $0.24 for the first quarter of 2020. The change in basic and diluted net loss per share is primarily a result of increased shares outstanding in connection with sales of common stock during the first quarter of 2021.