On May 10, 2021 Allergan Aesthetics, an AbbVie company (NYSE: ABBV) and Soliton (NASDAQ: SOLY) reported a definitive agreement under which Allergan Aesthetics will acquire Soliton and RESONICTM, its Rapid Acoustic Pulse device which recently received U.S. Food and Drug Administration (FDA) 510(k) clearance and is a non-invasive treatment for the short-term improvement in the appearance of cellulite (Press release, AbbVie, MAY 10, 2021, View Source [SID1234580065]). The acquisition of Soliton expands and complements Allergan Aesthetics’ Body Contouring treatment portfolio which includes CoolSculpting Elite.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The novel platform technology uses non-invasive rapid, high-frequency sound waves to disrupt targeted cellular structures and connective tissue, physically impacting the fibrous septae beneath the skin that contribute to the dimpled appearance of cellulite. In clinical trial data submitted to the FDA, after a single treatment session RESONICTM demonstrated significant improvement and strong patient satisfaction with 92.9 percent of subjects agreeing or strongly agreeing their cellulite appeared improved.

"There is a huge unmet need to address cellulite and effective treatments have been elusive and frustrating for consumers," said Carrie Strom, President, Global Allergan Aesthetics and Senior Vice President, AbbVie. "Soliton’s technology offers a new, completely non-invasive approach with clinically-proven results to reduce the appearance of cellulite with no patient downtime. The addition of this technology complements Allergan Aesthetics’ portfolio of body contouring treatments. Health care providers will now have another option to address consumers’ aesthetic concerns."

"Allergan Aesthetics’ brand recognition, global footprint, track record and commitment to developing best-in-class aesthetic treatments makes the Company ideally suited to maximize the commercial potential of the RESONICTM rapid acoustic pulse technology," said Walter Klemp, Executive Chairman, Soliton. "I am proud of the passion and accomplishments of the Soliton team and thankful for the ongoing support of our investors which have culminated in this transaction. We look forward to working with Allergan Aesthetics to ensure a successful completion of this transaction."

Under the terms of the transaction, Allergan Aesthetics will pay $22.60 per share in cash for each outstanding share of Soliton. Soliton’s enterprise value for the transaction is approximately $550 million and was approved by the Boards of Directors of both companies. The transaction is subject to customary closing conditions, including clearance by the U.S. antitrust authorities under the Hart-Scott-Rodino Act and approval of Soliton’s shareholders. Guggenheim Securities served as financial advisor to Soliton and Hogan Lovells served as legal counsel to Soliton.

RESONICTM has also received FDA 510(k) clearance for use in conjunction with laser for tattoo removal and has demonstrated clinical results in fibrotic scars.

On May 10, 2021 Celcuity Inc. (NASDAQ:CELC), a clinical-stage biotechnology company pursuing an integrated companion diagnostic (CDx) and therapeutic strategy for treating patients with cancer, reported financial results for the first quarter ended March 31, 2021 and summarized recent business progress (Press release, Celcuity, MAY 10, 2021, View Source [SID1234580661]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"Celcuity took a transformational strategic step in April when we entered into a global licensing agreement with Pfizer to obtain exclusive rights to develop and commercialize gedatolisib, a pan-PI3K/mTOR inhibitor, in clinical development to treat patients with ER+/HER2-negative advanced or metastatic breast cancer," said Brian Sullivan, CEO and co-founder of Celcuity. "Celcuity is planning to initiate, subject to feedback from the FDA, a Phase 2/3 clinical trial evaluating gedatolisib in combination with palbociclib and an endocrine therapy in the first half of 2022. We have a highly experienced drug development team and the financial resources in place to advance the gedatolisib program and are excited by the opportunity to utilize our CELsignia cellular analysis platform to support the development of a potential first-in-class targeted cancer therapy like gedatolisib."

First Quarter 2021 Business Highlights and Other Recent Developments

In January, Celcuity entered a collaboration with Sarah Cannon Research Institute and Pfizer Inc. to conduct an open-label Phase 2 clinical trial. This trial will evaluate the efficacy and safety of two Pfizer targeted therapies, VIZIMPRO, a pan-HER inhibitor, and XALKORI, a c-Met inhibitor, in patients with previously treated metastatic HER2-negative breast cancer selected with Celcuity’s CELsignia Multi-Pathway Activity Test. Celcuity believes there is significant clinical interest in finding new diagnostic tests and targeted therapies for patients with metastatic HER2-negative breast cancer whose disease progressed on prior therapies. Patient enrollment is expected to begin in the second or third quarter of 2021 with interim results in the second half of 2022.
Celcuity raised approximately $43.0 million of gross proceeds from financings in the first quarter of 2021 and April 2021.
In late February, Celcuity completed a successful follow-on public offering that raised gross proceeds of approximately $27.6 million.
In early April, Celcuity entered into a debt financing agreement with Innovatus Life Sciences Lending Fund I, LP to provide up to $25.0 million in term loans with the first tranche of $15.0 million funded at closing. Celcuity will be able to draw on two additional tranches of $5.0 million each upon the achievement of certain clinical trial and financing milestones.
In March, Celcuity entered into a clinical trial collaboration with MD Anderson, Novartis, and Puma Biotechnology to evaluate the efficacy and safety of Novartis’ targeted therapy TABRECTA and Puma’s NERLYNX in patients with metastatic HER2-negative breast cancer selected by Celcuity’s CELsignia Multi-Pathway Activity Test. This is Celcuity’s second clinical trial to treat patients diagnosed with hyperactive HER2 and c-Met signaling breast cancers with matching targeted therapies and Celcuity now has five clinical trial collaborations in place.
In April, Celcuity entered a worldwide licensing agreement with Pfizer for the exclusive right to develop and commercialize gedatolisib. Gedatolisib is in Phase 1b clinical development for the treatment of patients with ER+/HER2-negative advanced or metastatic breast cancer. Celcuity announced preliminary data for the 103 patients enrolled in the expansion portion of the ongoing Phase 1b clinical trial evaluating gedatolisib, plus Ibrance and endocrine therapy. As of the January 11, 2021 data cut-off, 53 of the 88 evaluable patients (60%) had an objective response. Gedatolisib was also generally well tolerated, with the majority of treatment-related adverse events (TRAE) being Grade 1 or 2. The most common Grade 3 or 4 TRAEs related to gedatolisib were stomatitis and rash. Celcuity plans to meet with the FDA later this year to discuss its clinical development plans for gedatolisib.
In April, Celcuity presented results of studies evaluating gedatolisib, inavolisib (a PI3K-α inhibitor), and navitoclax (a BCL inhibitor) in breast and ovarian patient tumors in two posters at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting. The results showed that gedatolisib inhibited nine times more signaling test activity in tumors with hyperactive RAS network signaling, on average, than inavolisib, when evaluated at equal concentrations with the CELsignia test. Gedatolisib at one-fifth the concentration of inavolisib (30 nM vs. 150 nM), inhibited five times more signaling activity as quantified by the CELsignia test. Data also showed that synergistic cooperation between PI3K/mTOR and BCL signaling was detected, suggesting potential patient benefit of combining gedatolisib with a BCL inhibitor.
First Quarter 2021 Financial Results
Unless otherwise stated, all comparisons are for the first quarter ended March 31, 2021, compared to the first quarter ended March 31, 2020.

Total operating expenses were $2.79 million for the first quarter of 2021, compared to $2.31 million for the first quarter of 2020.

Research and development (R&D) expenses were $2.24 million for the first quarter of 2021, compared to $1.85 million for the first quarter of 2020. The approximately $0.39 million increase during the first three months of fiscal year 2021, compared to the first three months of fiscal year 2020, resulted from a $0.06 million increase in compensation related expenses, which included a decrease of approximately $0.04 million of non-cash stock-based compensation expense. In addition, other research and development expenses increased $0.33 million due to clinical validation and laboratory studies, and operational and business development activities.

General and administrative (G&A) expenses were $0.56 million for the first quarter of 2021, compared to $0.46 million for the first quarter of 2020. The approximately $0.09 million increase during the first three months of fiscal year 2021, compared to the first three months of fiscal year 2020, resulted primarily from a $0.08 million increase in professional fees associated with being a public company and director and officer insurance.

Net loss for the first quarter of 2021 was $2.79 million, or $0.25 per share, compared to a net loss of $2.25 million, or $0.22 per share, for the first quarter of 2020. Non-GAAP adjusted net loss for the first quarter of 2021 was $2.34 million, or $0.21 per share, compared to non-GAAP adjusted net loss of $1.78 million, or $0.17 per share, for the first quarter of 2020. Non-GAAP adjusted net loss excludes stock-based compensation expense. Because this item has no impact on Celcuity’s cash position, management believes non-GAAP adjusted net loss better enables Celcuity to focus on cash used in operations. For a reconciliation of financial measures calculated in accordance with generally accepted accounting principles in the United States (GAAP) to non-GAAP financial measures, please see the financial tables at the end of this press release.

Net cash used in operating activities for the first quarter of 2021 was $2.52 million, compared to $1.83 million for the first quarter of 2020.

At March 31, 2021, Celcuity had cash and cash equivalents of $34.9 million, compared to cash and cash equivalents of $11.6 million at December 31, 2020. On April 8, 2021, Celcuity paid an upfront license fee of $5.0 million in conjunction with the Pfizer gedatolisib license agreement and received $14.5 million of net proceeds from a debt financing agreement. Taking into account these two events subsequent to the end of the first quarter, Celcuity has approximately $44.0 million of cash-on-hand.

Anticipated Milestones
Celcuity expects to do the following over the next twelve months:

Announce additional clinical trial collaborations in the first half of 2021 utilizing the CELsignia platform.
Initiate Phase 2/3 clinical trial for gedatolisib in breast cancer in the first half of 2022 pending discussions with the FDA regarding the clinical development pathway.
Provide interim results from the FACT-1 and FACT-2 trials in late 2021 or early 2022.
Webcast and Conference Call Information
The Celcuity management team will host a webcast/conference call at 4:30 p.m. ET today to discuss the first quarter financial results and provide a corporate update. To participate in the teleconference, domestic callers should dial 1-877-407-8035 and international callers should dial 201-689-8035. A live webcast presentation can also be accessed using this weblink: View Source A replay of the webcast will be available on the Celcuity website following the live event.

On May 10, 2021 Cellectar Biosciences, Inc. (NASDAQ: CLRB), a late-stage clinical biopharmaceutical company focused on the discovery and development of drugs for the treatment of cancer, reported financial results for the first quarter ended March 31, 2021 and provided a corporate update (Press release, Cellectar Biosciences, MAY 10, 2021, View Source [SID1234579549]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

First Quarter and Recent Corporate Highlights

Initiated pivotal study of CLR 131 in Waldenstrom’s macroglobulinemia (CLOVER-WaM)

Pivotal study is designed as a global, single arm, non-comparator, expansion cohort of the currently ongoing Phase 2 CLOVER-1 study of CLR 131 and its design is in alignment with feedback received from the U.S. FDA from Cellectar’s September 2020 guidance meeting
The study will enroll 50 relapsed/refractory WM patients
The primary endpoint of the study is major response rate defined as a partial response or better (a minimum of a 50% reduction in the biological marker IgM)

Received Orphan Drug Designation from the European Commission for CLR 131 in Waldenstrom’s macroglobulinemia (WM) which provides 10 years of European market exclusivity and certain benefits including protocol assistance, reduced EU regulatory filing and associated fees

Strengthened its global Intellectual Property portfolio with granted patents in Japan, Eurasia, Australia and Mexico. These patents, entitled: "Phospholipid-Ether Analogs as Cancer-Targeting Drug Vehicles," provides composition of matter and use protection for the company’s proprietary phospholipid-ether (PLE) analogs as a targeted delivery vehicle in combination with a broad range of commonly used chemotherapeutic classes such as alkaloids, nucleoside analogs, as well as other classes of small molecule chemotherapeutic agents
"During the first quarter, we focused on clinical study execution, ramped-up our pivotal study in Waldenstrom’s macroglobulinemia and further enriched our refractory multiple myeloma data set," said James Caruso, president and CEO of Cellectar. "We also continue to make progress in our pediatric study of CLR 131 in children with relapsed or refractory solid tumors or malignant brain tumors and remain well positioned financially with a cash runway supporting our current strategic plan into the third quarter of 2023."

First Quarter Financial Highlights

Cash and Cash Equivalents: As of March 31, 2021, the company had cash and cash equivalents of $53.6 million compared to $57.2 million at December 31, 2020.

Research and Development Expense: Research and development expense for the three months ended March 31, 2021 was approximately $4.6 million compared to approximately $2.6 million for the three months ended March 31, 2020. The overall increase in research and development expense of $2.0 million was primarily a result of costs related to our WM pivotal study. General research and development costs increased because of increased personnel and related costs offset by a decrease in manufacturing and related costs and preclinical study costs.

General and Administrative Expense: General and administrative expense for the three months ended March 31, 2021 was approximately $1.7 million, compared to approximately $1.3 million for the three months ended March 31, 2020. The overall increase in general and administrative expense of $384,000 was primarily a result of professional fees and insurance.

Net Loss: The net loss attributable to common stockholders for the three months ended March 31, 2021 was ($6.4) million, or ($0.13) per share, compared to ($4.0) million, or ($0.42) per share, for the three months ended March 31, 2020.

On May 10, 2021 Revolution Medicines, Inc. (Nasdaq: RVMD), a clinical-stage precision oncology company focused on developing targeted drugs to inhibit frontier targets that drive and sustain RAS-addicted cancers, reported its financial results for the first quarter of 2021 and provided a corporate update (Press release, Revolution Medicines, MAY 10, 2021, View Source [SID1234579576]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"Revolution Medicines has made excellent progress reinforcing our belief that the company’s cohesive portfolio of innovative clinical and preclinical assets will power compelling rational, mechanism-based combination treatments that provide benefit to patients with RAS-addicted cancers," said Mark A. Goldsmith, M.D., Ph.D., chief executive officer and chairman of Revolution Medicines.

"We presented data at the AACR (Free AACR Whitepaper) Annual Meeting 2021 demonstrating the attractive preclinical profiles of two pioneering RAS(ON) inhibitor candidates that are currently undergoing IND-enabling development, RMC-6291 (KRASG12C) and RMC-6236 (RASMULTI). These first examples of RAS(ON) inhibitors intended for human use exhibit differentiated breadth, depth and durability of anti-tumor effects in human cancer models. Further, an important recent scientific paper described multiple genetic mutations causing clinical resistance to leading KRASG12C(OFF) inhibitors but with preserved sensitivity to RAS(ON) inhibitors from our collection. We believe that RMC-6291, RMC-6236 and additional emerging inhibitors in our portfolio hold great promise for use in treating, and overcoming resistance in, patients with a diverse range of RAS-addicted cancers lacking adequate targeted therapeutics.

"The company also continues broad-based initiatives with our RAS Companion Inhibitor portfolio. For RMC-4630 (SHP2), combination approaches with multiple direct RAS inhibitors remain a high-priority treatment strategy supported by the clinical and preclinical anti-tumor activity, resistance and safety data observed to date across these classes of targeted agents. Amgen’s CodeBreaK 101c study evaluating the combination with sotorasib has demonstrated acceptable tolerability, has cleared early dose levels and is currently dosing patients at the target dose of RMC-4630 (200 mg on a Day 1/Day 2 weekly schedule). We also continue evaluating a second, distinct group of treatment strategies for RMC-4630 in combination with established drugs that potently suppress the RAS signaling pathway, including cobimetinib, a MEK inhibitor and osimertinib, an EGFR inhibitor, to determine whether enhanced pathway inhibition from these drug combinations delivers sufficient anti-tumor activity and tolerability to confer clinical benefit.

"We are also pleased to have begun clinical evaluation of RMC-5552 (mTORC1/4EBP1) in a monotherapy dose-escalation study. In aggregate, these projects with our RAS Companion Inhibitor portfolio, including continued IND-enabling development of RMC-5845 (SOS1), support our long-term goal of combining these assets with RAS(ON) Inhibitors on behalf of patients selected by molecular tumor features.

"To support the expanded and advancing pipeline, Revolution Medicines successfully completed a financing in the first quarter that helped position the company with a strong balance sheet."

R&D Highlights

RAS(ON) Inhibitors – Revolution Medicines continues maturing its first-in-class RAS(ON) Inhibitor platform, including an expansive collection of tri-complex inhibitors targeting diverse oncogenic RAS variants through highly differentiated chemical and pharmacologic profiles.

Potential advantages of RAS(ON) Inhibitors – A recent paper in Cancer Discovery by Dr. Ryan Corcoran’s team at the Massachusetts General Hospital/Harvard Medical School identified multiple resistance mutations that bypass the effects of three first-generation KRASG12C(OFF) inhibitors. Importantly, the researchers found that a KRASG12C-selective RAS(ON) tool compound from the Revolution Medicines portfolio, RM-018, retained potent binding and inhibitory activity against tumor cells harboring an on-target mutation that conferred resistance to all three KRASG12C(OFF) inhibitors tested.

RMC-6291 (KRASG12C)

RMC-6291 is a first-in-class, potent, oral and selective tri-complex inhibitor of KRASG12C(ON) and NRASG12C(ON) with an attractive and differentiated preclinical profile designed to address persistent unmet needs for patients with cancers caused by KRASG12C or NRASG12C.
Data presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2021 showed superior anti-tumor activity for RMC-6291 in preclinical lung and colorectal cancer models driven by a KRASG12C mutation.
The company remains on track to submit an investigational new drug (IND) application in the first half of 2022.

RMC-6236 (RASMULTI)

RMC-6236 is a first-in-class, potent, oral RAS-selective tri-complex, RASMULTI(ON) inhibitor with an attractive preclinical profile and is designed to treat cancers caused by multiple RAS variants for which no targeted treatment is currently available.
Data presented at the recent AACR (Free AACR Whitepaper) meeting demonstrated deep anti-tumor activity of RMC-6236 in preclinical lung, colorectal and pancreatic cancer models driven by various mutations that are common drivers of human cancers, including KRASG12V and KRASG12D.
The company remains on track to submit an IND in the first half of 2022.

Continued expansion of other RAS(ON) inhibitor programs – Revolution Medicines continues to progress an expanding portfolio of potent, cell-active RAS(ON) Inhibitors with the potential to target RAS variants driving the vast majority of RAS-addicted cancers. In particular, the company’s KRASG12D- and KRASG13C-selective programs continue to advance in lead optimization. The company remains on track to nominate a third development candidate from its RAS(ON) inhibitor portfolio in the second half of 2021.
RAS Companion Inhibitors – Revolution Medicines continues to advance and expand multiple clinical studies both as monotherapy and in targeted drug combinations designed to achieve maximum clinical benefit.

RMC-4630 (SHP2 Inhibitor) – RMC-4630 is a potent, oral, selective inhibitor of the SHP2 protein, a central node in the RAS signaling pathway. Its development is being advanced in partnership with, and is primarily funded by, Sanofi, both as monotherapy and in several current and planned combinations.
RMC-4630 and KRASG12C inhibitor sotorasib

To date, the available data from the ongoing Amgen-sponsored CodeBreaK 101c study of the RMC-4630 and sotorasib combination has demonstrated acceptable tolerability and cleared early dose levels.
The CodeBreaK 101c study is currently dosing patients at the target dose of RMC-4630 (200 mg on a Day 1 / Day 2 weekly schedule, the full dose used by the company in monotherapy) in combination with sotorasib. The company looks forward to selection of a combination dose for this study in the second half of 2021.
RMC-4630 and AstraZeneca KRASG12C inhibitor

AstraZeneca plans to evaluate RMC-4630 in combination with an emerging asset targeting KRASG12C(OFF) from AstraZeneca’s portfolio
RMC-4630 and MEK inhibitor cobimetinib (Cotellic)

Phase 1b/2 study of this combination is ongoing, including in expansion cohorts of patients with KRASMUTANT colorectal cancer at the recommended Phase 2 dose and schedule (RP2DS) for this combination. The company continues to expect preliminary safety and clinical activity data from this expansion study in 2022.
RMC-4630 and EGFR inhibitor osimertinib (Tagrisso)

Dosing and enrollment continue in the Phase 1b study of this combination and the company continues to expect initial tolerability and pharmacokinetic (PK) data in the second half of 2021.
RMC-4630 and PD-1 inhibitor pembrolizumab (Keytruda)

Sanofi-sponsored Phase 1 study of this combination continues. The RP2DS for this combination is expected in the first half of 2021 and expansion cohorts evaluating this combination in patients with non-small cell lung cancer (NSCLC) are planned.
RMC-4630 monotherapy

Presented dose escalation activity data set from the ongoing Phase 1 study at the recent AACR (Free AACR Whitepaper) meeting, showing anti-tumor activity and safety and tolerability that is consistent with on-pathway inhibition, delivering on a corporate milestone.
Data presented at AACR (Free AACR Whitepaper) meeting showed reduction of variant allele frequency in circulating tumor DNA (ctDNA) samples from patients treated with RMC-4630 for cancers carrying KRASG12C or NF1LOF, further validating the expected clinical mechanism of action of RMC-4630.
RMC-5552 (mTORC1/4EBP1 Inhibitor) – RMC-5552 is a potent, selective bi-steric inhibitor of mTORC1 that suppresses phosphorylation and inactivation of 4EBP1.

Dosing and enrollment are underway in the recently initiated Phase 1 monotherapy dose-escalation study, delivering on a corporate milestone. The company continues to expect initial safety, PK and single agent activity data in 2022.
Preclinical data presented at the recent AACR (Free AACR Whitepaper) meeting demonstrated that bi-steric mTORC1-selective inhibitors drive significant anti-tumor activity as monotherapy and in combination with KRASG12C inhibitors in genetically-defined preclinical models of human cancers.
The company intends to evaluate RMC-5552 in combination with RAS inhibitors for the treatment of tumors driven by co-occurring RAS mutations and genomic activation of the mTORC1 pathway.

RMC-5845 (SOS1 Inhibitor) – RMC-5845 is a potent, selective, oral inhibitor of SOS1, a major switch in the cycling of RAS(OFF) to RAS(ON).

The company remains on track to submit an IND in the second half of 2021 to enable an initial monotherapy dose escalation study and intends to evaluate RMC-5845 for treatment of certain genetically defined RAS-dependent cancers.
Corporate Highlights

Completed upsized financing to strengthen balance sheet and support advancement of expanding pipeline – Public offering of common stock in February 2021 raised net proceeds of $281 million, enabling the company to advance its pipeline, including RAS(ON) Inhibitors RMC-6291 and RMC-6236, through early Phase 1 signal-seeking clinical studies.

Flavia Borellini, Ph.D. joins existing board members Elizabeth McKee Anderson and Neil Exter as Class I director nominee – Dr. Borellini has more than 25 years of executive management experience in the pharmaceutical and biotechnology industry, with a particular focus on global development of targeted oncology drugs, from preclinical to commercial stage.
First Quarter 2021 Financial Highlights

Cash Position: Cash, cash equivalents and marketable securities were $681.6 million as of March 31, 2021, compared to $440.7 million as of December 31, 2020. The increase was primarily due to proceeds from the company’s equity public offering in February 2021.

Revenue: Total revenue, consisting of revenue from the company’s collaboration agreement with Sanofi, was $10.1 million for the quarter ended March 31, 2021, compared to $11.5 million for the quarter ended March 31, 2020. The decrease was due to lower reimbursed research and development services for RMC-4630 resulting from lower manufacturing costs.

R&D Expenses: Research and development expenses were $40.9 million for the quarter ended March 31, 2021, compared to $27.5 million for the quarter ended March 31, 2020. The increase was primarily due to an increase in research expenses associated with the company’s pre-clinical research portfolio, an increase in personnel-related expenses related to additional headcount, and an increase in stock-based compensation.

G&A Expenses: General and administrative expenses were $6.7 million for the quarter ended March 31, 2021, compared to $5.2 million for the quarter ended March 31, 2020. The increase was primarily due to an increase in personnel-related expenses related to additional headcount, and an increase in stock-based compensation.

Net Loss: Net loss was $37.2 million for the quarter ended March 31, 2021, compared to net loss of $19.5 million for the quarter ended March 31, 2020.

2021 Financial Guidance

Revolution Medicines continues to expect full year 2021 GAAP net loss to be between $170 million and $190 million, which includes estimated non-cash stock-based compensation expense of $20 million to $25 million.

On May 10, 2021 Pieris Pharmaceuticals, Inc. (NASDAQ:PIRS), a clinical-stage biotechnology company advancing novel biotherapeutics through its proprietary Anticalin technology platform for respiratory diseases, cancer and other indications, reported that it will host a first quarter 2021 investor call on Monday, May 17, 2021 at 8:00 AM EDT to discuss financial results and provide a corporate update (Press release, Pieris Pharmaceuticals, MAY 10, 2021, View Source [SID1234579596]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

To access the call, participants may dial 877-407-8920 (Toll Free US & Canada) or 412-902-1010 (International) at least five minutes prior to the start of the call. Alternatively, a listen-only audio webcast of the call can be accessed here.

For those unable to participate in the conference call or listen to the webcast, a replay will be available on the Investors section of the Company’s website, www.pieris.com.