On May 6, 2021 Cardiff Oncology, Inc. (Nasdaq: CRDF), a clinical-stage biotechnology company developing onvansertib to treat cancers with the greatest medical needs for new treatment options, including KRAS-mutated colorectal cancer, pancreatic cancer and castrate-resistant prostate cancer, reported recent company highlights and financial results for the first quarter ended March 31, 2021 (Press release, Cardiff Oncology, MAY 6, 2021, View Source [SID1234579336]). The Company is issuing this press release in lieu of conducting a conference call.

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"We are off to a strong start in 2021 thanks in large part to our successful financing late last year, which has allowed us to advance our clinical development programs, more fully leverage onvansertib combination trials across multiple cancer indications, and work towards strengthening company leadership," said Dr. Mark Erlander, chief executive officer of Cardiff Oncology. "As presented at ASCO (Free ASCO Whitepaper)-GI in January and our KOL Event in early April, our KRAS-mutated metastatic colorectal cancer (mCRC) trial continues to generate consistent and encouraging data, with a robust overall response rate and median progression free survival that compare favorably to historical controls. These data also provide a strong scientific rationale for our Phase 2 trial in pancreatic ductal adenocarcinoma (PDAC), an indication where approximately 95% of patients have a KRAS mutation. We recently activated our first sites for this trial, which, similar to our mCRC trial, will treat patients with onvansertib in combination with irinotecan and 5-FU."

Dr. Erlander continued, "The progress in our KRAS-mutated cancer programs is complemented by promising data from our Phase 2 trial in metastatic castrate-resistant prostate cancer (mCRPC), which continues to demonstrate durable disease control in patients showing initial abiraterone resistance and highlights onvansertib’s ability to disrupt or inhibit additional tumor-promoting pathways. In parallel, in vitro studies in mCRPC indicate that onvansertib and abiraterone can synergistically interact by upregulating a mitosis related gene signature and disrupting mitotic spindle orientation. We are currently testing this prospectively in our ongoing trial to assess whether the presence of this signature in the tumor can predict which patients are most likely to respond to onvansertib-abiraterone combination therapy. We look forward to the continued progression of this trial as well as our other clinical programs, which together are expected to drive increased value throughout 2021."

Program highlights for the quarter ended March 31, 2021, along with recent developments, include:

KRAS-mutated Metastatic Colorectal Cancer (mCRC) Program:

Announced updated data from the Phase 1b/2 trial evaluating onvansertib plus FOLFIRI/bevacizumab that continues to demonstrate robust response to treatment and progression-free survival in KRAS-mutated mCRC

Updated data from Cardiff Oncology’s Phase 1b/2 mCRC trial were presented in conjunction with the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Gastrointestinal Cancers Symposium (ASCO-GI) in January and as part of a separate Key Opinion Leader webinar in April. Results from the trial continue to show robust patient response and progression-free survival when onvansertib is combined with standard-of-care therapy in second line KRAS-mutated mCRC. Data highlights from the Phase 1b trial, as of April 4, 2021, include:

7 of 18 (39%) evaluable patients achieved a partial response (PR); 4 patients had a confirmed PR with 1 patient going on to curative surgery; 1 patient with a non-confirmed PR went off study following PR prior to confirmatory scan due to a treatment-unrelated adverse event; 2 patients with non-confirmed PRs await confirmatory scans and results
Evaluable patients have a median progression free survival (mPFS) of 9.4 months (95% confidence interval: 7.85 months – not reached), more than double the historical 4.5-month mPFS from analysis of 23 randomized trials in second-line metastatic colorectal cancer (data from ~10,800 patients)¹
7 patients remain on treatment
Clinical responses were observed across different KRAS mutations, including the 3 most common in colorectal cancer (G12D, G12V, G13D)
The greatest decreases in plasma KRAS mutant allelic frequency (MAF) after 1 cycle of treatment were observed in patients achieving a PR
Onvansertib in combination with FOLFIRI/bevacizumab has been well tolerated with no major or unexpected toxicities attributed to onvansertib
Enrollment of patients in the Phase 1b segment of the trial concluded in December 2020 and the first patient in the Phase 2 segment of the trial had their first treatment in February 2021. Phase 2 is rapidly accruing the approximately 26 patients needed to complete the study across 7 trial sites: USC Norris Comprehensive Cancer Center, Mayo Clinic Cancer Centers (Arizona, Rochester and Jacksonville), Kansas University Medical Center, CARTI Cancer Center and Inova Schar Cancer Institute.

Presented findings from the Expanded Access Program (EAP) for onvansertib in KRAS-mutated mCRC highlighting the clinical benefit of onvansertib in heavily pretreated patients

Findings from Cardiff Oncology’s EAP were presented at ASCO (Free ASCO Whitepaper)-GI in January and at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2021 in April. The EAP has enrolled participants who failed or progressed on multiple lines of standard-of-care treatment and uses the same combination regimen (onvansertib 15 mg/m2 + FOLFIRI/bevacizumab) and dosing schedule as the ongoing Phase 1b/2 mCRC clinical trial. In the most recent update at the AACR (Free AACR Whitepaper) Annual Meeting, the Company presented findings from 20 evaluable participants who were heavily pre-treated (median of 3 prior lines of treatment). Highlights from the AACR (Free AACR Whitepaper) presentation included:

15 of 20 (75%) evaluable participants received an irinotecan-based regimen as their last therapy prior to enrolling in the EAP.
13 of 20 (65%) evaluable participants were progressing prior to enrolling in the EAP
Median progression free survival (mPFS) was 5.6 months (95% confidence interval: 2.7 months – not reached), which is significantly greater than historical controls (2-3 months)2
62.5% of participants had a greater than 50% decrease in KRAS MAF after one cycle of treatment and continue to show a durable response and have not reached mPFS
11 of 20 of evaluable participants remain on treatment
Onvansertib in combination with FOLFIRI/bevacizumab has been well tolerated with no serious adverse events (SAEs) reported
Hosted a Key Opinion Leader (KOL) webinar highlighting the findings from the onvansertib Phase 1b/2 trial and EAP

The call featured KOLs Daniel H. Ahn, D.O., M.S. (Mayo Clinic Arizona), and Manish R. Sharma, M.D. (START Midwest). In addition to highlighting the latest data and findings from the onvansertib Phase 1b/2 mCRC trial and EAP, the call also included an overview of the current treatment landscape in KRAS-mutated mCRC and a discussion of the response rates and progression free survival historically achieved with the current second-line standard of care. You may access a replay of the event by clicking here.

Metastatic Castrate-Resistant Prostate Cancer (mCRPC) Program:

Announced updated Phase 2 data showing a two-fold increase in efficacy with an optimized onvansertib dosing schedule

Updated data from a Phase 2 trial evaluating the all-oral combination of onvansertib, abiraterone and prednisone in patients showing initial abiraterone resistance were featured in a virtual oral poster presentation at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Genitourinary Cancers Symposium (ASCO-GU). These data showed that increasing the number of days of treatment with onvansertib from 5 to 14 in a 21-day cycle was associated with a greater than two-fold increase (29% to 63%) in disease control rate (DCR) at 12 weeks, the trial’s primary efficacy endpoint. Across all cohorts, the DCR at 12 weeks is 35% (13/37), indicating the trial is on track to meet the stated criteria for success on the primary efficacy endpoint (30% DCR at 12 weeks). Additional highlights from the ASCO (Free ASCO Whitepaper)-GU presentation included:

The optimized dosing schedule of cohort C shows a greater than two-fold improvement in disease control rate compared to cohorts A and B, with 63% (5/8) of cohort C patients achieving the primary efficacy endpoint compared to 29% (5/17) and 25% (3/12) of cohort A and B patients, respectively
75% (6/8) of evaluable patients in cohort C had radiographic stable disease (SD) at 12 weeks, compared to 53% (9/17) in cohort A, 42% (5/12) in cohort B and 54% (20/37) across all cohorts
All cohort C patients achieving the primary efficacy endpoint remain on treatment
Data show that the combination of onvansertib and abiraterone is well tolerated across all dosing cohorts.
Additional information on the trial and dosing cohorts can be found here.

Identified an androgen-independent mechanism of synergy between onvansertib and abiraterone in mCRPC

Collaborative studies with the Massachusetts Institute of Technology featured in a virtual oral poster presentation at the AACR (Free AACR Whitepaper) Annual Meeting 2021 suggest that the androgen receptor signaling inhibitor abiraterone sensitizes certain prostate cancer cells to onvansertib via the induction of a mitosis related gene signature and disruption of mitotic spindle orientation. These results are consistent with previous findings showing that onvansertib and abiraterone synergize in an androgen receptor-independent manner in vitro and in vivo. Data from the studies also suggest that the identified mitosis related gene signature may be predictive of patient response to onvansertib-abiraterone combination therapy, a hypothesis that is being further assessed in the ongoing Phase 2 mCRPC trial.

Metastatic Pancreatic Ductal Adenocarcinoma (PDAC) Program:

Opened enrollment for a Phase 2 trial of onvansertib in metastatic PDAC

Cardiff Oncology recently activated the first clinical sites for its Phase 2 clinical trial of onvansertib in metastatic PDAC, which is now open for enrollment. The trial is designed to assess the safety and preliminary efficacy of onvansertib in combination with nanoliposomal irinotecan (Onivyde), leucovorin and fluorouracil (5-FU) as a second-line treatment in patients with metastatic PDAC who have failed first-line gemcitabine-based therapy. Onvansertib’s potential in PDAC, where ~95% of patients have a KRAS mutation, is supported by the promising clinical data seen in KRAS-mutated mCRC patients treated with the combination of onvansertib, irinotecan and 5-FU (FOLFIRI).

Sale of Common Stock to Institutional Investor:

On May 5, 2021, the Company agreed to sell 2.0 million shares of its Common Stock to a healthcare institutional investor for gross proceeds of $20.0 million under the Sales Agreement with Jeffries LLC.

First Quarter 2021 Financial Results:

As of March 31, 2021, Cardiff Oncology had approximately $125.6 million in cash, cash equivalents and short-term investments.

Total operating expenses were approximately $5.5 million for the three months ended March 31, 2021, an increase of $1.3 million from $4.2 million for the same period in 2020. The increase in operating expenses is attributed to advancing onvansertib drug development activities, additional clinical studies and increased outside services for legal fees mainly related to the expansion of our patent portfolio and recruiting fees.

Net cash used in operating activities in the first quarter of 2021 was $5.9 million, an increase of $2.5 million from $3.4 million for the same period in 2020. The increase is attributed to expanding and advancing drug development and clinical program activities, and net changes in assets and liabilities.

Research and development expenses increased by approximately $0.6 million to $3.3 million for the three months ended March 31, 2021, from $2.7 million for the same period in 2020. The increase in research and development expenses was primarily due to advancing the onvansertib clinical and preclinical programs.

Selling, general and administrative expenses increased by approximately $0.7 million to $2.2 million for the three months ended March 31, 2021, from $1.5 million for the same period in 2020. The increase is primarily due to increased outside services for legal fees mainly related to the expansion of our patent portfolio and recruiting fees.

On May 6, 2021 Coherus BioSciences, Inc. ("Coherus" or the "Company", Nasdaq: CHRS), reported financial results for the quarter ended March 31, 2021 (Press release, Coherus Biosciences, MAY 6, 2021, View Source [SID1234579335]). The Company also provided a progress update on its anti-PD-1 antibody, toripalimab, its lead immuno-oncology candidate for the potential treatment of various solid tumors, as well as other late-stage pipeline product candidates including CHS-201, a biosimilar Lucentis (ranibizumab), CHS-1420, a wholly owned biosimilar Humira (adalimumab), and CHS-305, a biosimilar Avastin (bevacizumab).

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"Over the next two years, we project four additional Coherus product candidates will be approved in the United States, including three biosimilars and our anti-PD-1 antibody, toripalimab," said Denny Lanfear, CEO of Coherus. "We believe this diversified product portfolio has the potential to generate significant revenue growth and fuel our investments in novel immuno-oncology therapies with the potential to improve care and outcomes for cancer patients."

"With significant new clinical data and the first U.S. BLA submission underway, toripalimab is already exceeding our expectations," Lanfear continued. "During a rigorous multi-year evaluation of the global checkpoint inhibitor landscape, we defined the preclinical and clinical properties required for our investment in a PD-1 blocking antibody. Toripalimab’s demonstrated potency, unique molecular properties and advanced pivotal clinical development program in numerous cancer types surpassed our stringent criteria. It is gratifying to see the accumulating external validation for toripalimab including selection for ASCO (Free ASCO Whitepaper)’s plenary session, Breakthrough Therapy Designation from the FDA for nasopharyngeal carcinoma, and the additional recent approvals in China. We believe these developments and the external interest we have already received to evaluate potential toripalimab combinations positions this product candidate as a significant potential growth driver for Coherus for many years."

FIRST QUARTER 2021 FINANCIAL HIGHLIGHTS

GAAP net loss of $173 million for the first quarter of 2021 was primarily driven by the $145 million upfront payment to Junshi Biosciences for U.S. and Canada rights to the anti-PD-1 antibody toripalimab and one-time charges associated with the termination of the CHS-2020 biosimilar program as part of the strategic realignment of research and development resources toward immuno-oncology.
Non-GAAP net income for the first quarter of 2021 was $0.4 million, or $0.01 per share.
Cash flow from operations was $1.4 million.
Net product revenue, consisting of net sales of UDENYCA (pegfilgrastim-cbqv) was $83 million for the first quarter of 2021. With approximately 20% share of the overall pegfilgrastim market, UDENYCA maintains its position as the leading pegfilgrastim biosimilar.
Coherus had cash, cash equivalents and marketable securities of $400 million at March 31, 2021.
In April 2021, the Company received $50 million from Junshi Biosciences’ acquisition of 2,491,988 shares of Coherus stock at a price per share of $20.06.
PIPELINE HIGHLIGHTS

Toripalimab, a PD-1 blocking antibody product candidate, in collaboration with Junshi Biosciences:

Junshi Biosciences initiated the rolling submission of the biologics license application ("BLA") with the U.S. Food and Drug Administration ("FDA") for toripalimab for the treatment of recurrent or metastatic nasopharyngeal carcinoma ("NPC"). The FDA has granted toripalimab Breakthrough Therapy Designation for this indication. The BLA submission is expected to be completed mid-year 2021, with potential approval in the first half of 2022.
Results of JUPITER-02, a randomized, double-blind, placebo-controlled, multi-center, Phase 3 clinical trial evaluating toripalimab for first-line NPC, will be featured in the plenary session and in the official press program of the 2021 ASCO (Free ASCO Whitepaper) Annual Meeting in early June.
In JUPITER-06, a randomized, double-blind, placebo-controlled, multi-center, Phase 3 clinical trial with 514 patients enrolled, toripalimab in combination with paclitaxel/cisplatin as first-line treatment for patients with advanced esophageal squamous cell carcinoma ("ESCC") achieved the pre-specified primary endpoints of progression free survival ("PFS") and overall survival ("OS") at the interim analysis. Data from the study are expected later in 2021.
Coherus and Junshi Biosciences plan to file additional toripalimab BLA supplements with the FDA over the next three years for multiple rare and highly prevalent tumor types, including non-small cell lung cancer ("NSCLC"). An ongoing Phase 3 clinical study of toripalimab in combination with standard chemotherapy as the first-line treatment of patients with advanced NSCLC reached its primary endpoint of PFS at the interim analysis in December 2020. Top-line results are expected later in 2021.
CHS-201, a biosimilar Lucentis (ranibizumab) product candidate in collaboration with Bioeq AG:

Bioeq AG expects to file the CHS-201 BLA mid-year 2021, following a supportive pre-BLA meeting with the FDA earlier in the first quarter of 2021. Bioeq reviewed new manufacturing data with the FDA, which the agency requested last year, as well as other elements of the BLA filing.
CHS-1420, a wholly owned biosimilar Humira (adalimumab) product candidate:

The FDA accepted for review the BLA for CHS-1420 and assigned a target action date in December 2021. The FDA has completed the on-site portion of the pre-approval drug substance CMC inspection, with no Form 483s being issued. Coherus plans to launch CHS-1420 on or after July 1, 2023, if approved.
CHS-305, a biosimilar Avastin (bevacizumab) product candidate in collaboration with Innovent Biologics (Suzhou) Co. Ltd:

Coherus initiated the three-way pharmacokinetic study to facilitate the potential BLA submission. Recruitment into the study has been slower than expected as a result of the COVID-19 pandemic, and Coherus now expects data from this study around year end 2021.
Coherus is planning an analyst day event in the fourth quarter of 2021.

FIRST QUARTER 2021 FINANCIAL RESULTS

Net product revenue, consisting of net sales of UDENYCA, was $83 million for the first quarter of 2021. Net Product revenue declined in comparison to the prior quarter and the first quarter of 2020 due to an increase in discounts and allowances, as well as a reduction in ex-factory units sold due to seasonal fluctuations in wholesale inventory levels in the fourth quarter of 2020 and the first quarter of 2021.

Research and development (R&D) expenses for the first quarter of 2021 were $203.5 million, compared to $33.1 million for the same period in 2020. The increase was mainly due to the $145 million upfront payment to Junshi Biosciences upon the closing of the collaboration agreement in March, the $11.5 million charge related to the termination of the CHS-2020 program, and higher development costs in support of the advancement of toripalimab and the biosimilar pipeline product candidates.

Selling, general and administrative (SG&A) expenses were $39.4 million in the first quarter of 2021 as compared to $35.4 million in the year ago quarter. The increase was primarily driven by an increase in stock based compensation expense.

Net loss for the first quarter of 2021 was $172.9 million, or $2.37 per share on a diluted basis, compared to a net income of $35.6 million, or $0.48 per share on a diluted basis for the same period in 2020.

Non-GAAP net income for the first quarter of 2021 was $0.4 million, or $0.01 per share on a diluted basis, compared to non-GAAP net income of $49.8 million, or $0.67 per share on a diluted basis for the same period in 2020. See "Non-GAAP Financial Measures" below for a discussion on how Coherus calculates non-GAAP net income and a reconciliation to the most directly comparable GAAP measures.

Cash, cash equivalents and investments in marketable securities were $399.5 million as of March 31, 2021, compared to $541.2 million at year end 2020. Subsequent to quarter end, Coherus received $50 million from Junshi Biosciences’ acquisition of 2,491,988 shares at a price per share of $20.06.

2021 FINANCIAL OUTLOOK

Coherus expects UDENYCA revenue and market penetration to rise in the second half of 2021, assuming the COVID-19 pandemic recedes and treatment patterns normalize, and subject to pricing trends in the overall pegfilgrastim market.

Excluding the $145 million upfront payment made to Junshi Biosciences in the first quarter, Coherus projects full year R&D and SG&A expenses in a range of $370 million to $400 million. External R&D spending is focused on manufacturing-related activities in preparation for the potential launch of toripalimab and CHS-1420, if approved, and development activities for CHS-305 and for additional presentations of UDENYCA. Increases in SG&A spending in 2021 are primarily driven by marketing activities and headcount to support UDENYCA and the potential launches in 2022 of toripalimab and CHS-201 (Lucentis biosimilar).

This financial guidance excludes the effects of any potential future strategic acquisitions, collaborations or investments, the exercise of rights or options related to collaboration programs, and any other transactions or items not yet identified or quantified. This guidance is subject to a number of risks and uncertainties. See Forward-Looking Statements described in the section below and the section titled "Risk Factors" in the Company’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2021 to be filed with the Securities & Exchange Commission on May 6, 2021.

Conference Call Information

When: Thursday, May 6, 2021 starting at 4:30 p.m. ET

Dial-in: (800) 446-2782 (Toll-Free U.S. and Canada) or (847) 413-3235 (International)

Conference ID: 50149707

Webcast: View Source

Please join the conference call at least 10 minutes early to register. The webcast will be archived on the Coherus website.

On May 6, 2021 Corcept Therapeutics Incorporated (NASDAQ: CORT), a commercial-stage company engaged in the discovery and development of drugs to treat severe metabolic, oncologic and psychiatric disorders by modulating the effects of cortisol, reported positive results from its 178-patient, controlled, Phase 2 trial of relacorilant plus nab-paclitaxel in patients with recurrent platinum-resistant ovarian cancer (Press release, Corcept Therapeutics, MAY 6, 2021, https://ir.corcept.com/news-releases/news-release-details/addition-relacorilant-nab-paclitaxel-improves-progression-free [SID1234579334]).

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Women with platinum resistant ovarian cancer (n=60) who received 150 mg of relacorilant the day before, the day of and the day after their weekly nab-paclitaxel infusion exhibited a statistically significant improvement in progression free survival (hazard ratio 0.66, p-value 0.038) compared to women (n=60) who received nab-paclitaxel monotherapy; their median progression free survival was 1.8 months longer (5.6 vs 3.8 months). Safety data and tolerability data for the two groups were comparable. (See Figure 1)

A photo accompanying this announcement is available at View Source

A third cohort of patients (n=58) received a daily dose of relacorilant (100 mg per day, with titration to 150 mg per day at the investigator’s discretion) in addition to nab-paclitaxel. These patients’ median progression-free survival increased 1.5 months compared to the control arm, to 5.3 months, but this improvement did not reach statistical significance (hazard ratio 0.83).

"It’s impressive how this therapy extends the benefits of taxanes," said Professor Pamela Munster, MD, Director of the University of California San Francisco’s Early Phase Clinical Trials Unit and Co-leader of its Center for BRCA Research. "Patients with platinum-resistant ovarian cancer have few good treatment options. A therapy that significantly extends time to tumor progression without additional side effect burden would be an important advance."

Corcept has begun planning a pivotal Phase 3 trial.

About the Trial

This controlled, multi-center, Phase 2 trial enrolled 178 patients with platinum-resistant ovarian cancer in one of three study arms. Sixty patients received 150 mg relacorilant the day before, the day of and the day after their infusion of nab-paclitaxel. Fifty-eight patients received 100 mg relacorilant every day, with titration up to 150 mg permitted at the investigator’s discretion. The sixty patients in the control arm received nab-paclitaxel alone. All patients received nab-paclitaxel on Days 1, 8 and 15 of each 28-day cycle. Patients in the control arm received 100 mg/m2 of nab-paclitaxel. Because relacorilant increases nab-paclitaxel plasma levels, the nab-paclitaxel dose in patients receiving relacorilant was 80 mg/m2. The trial’s primary endpoint was progression free survival. Secondary endpoints include overall survival, objective response rate and duration of response. The trial is being conducted at 28 sites in the United States and Europe. Additional information about the study (NCT03776812) can be obtained at www.ClinicalTrials.gov.

About Relacorilant

Relacorilant is a non-steroidal, selective modulator of the glucocorticoid receptor that does not bind to the body’s other hormone receptors. Corcept is studying relacorilant in a variety of serious disorders, including ovarian, pancreatic and castration-resistant prostate cancer and Cushing’s syndrome. Relacorilant is proprietary to Corcept and is protected by composition of matter and method of use patents. It has received orphan drug designation in the United States for the treatment of Cushing’s syndrome and pancreatic cancer.

On May 6, 2021 Acorda Therapeutics, Inc. (Nasdaq: ACOR) reported its financial results for the first quarter 2021 (Press release, Acorda Therapeutics, MAY 6, 2021, View Source [SID1234579333]).

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"We were pleased to see the increase in INBRIJA net sales in the first quarter of 2021 over the same quarter of 2020. In addition, our organic growth, measured by the increase in dispensed cartons, was 25% compared to the first quarter of 2020 and also an acceleration versus last quarter. This is an encouraging sign that we may be starting to see the impact of a receding pandemic on our business," said Ron Cohen, M.D., Acorda’s President and Chief Executive Officer. "We continue to see renewed interest in ex-US commercial partnerships for INBRIJA, owing to the reduced cost of goods that resulted from the sale of our manufacturing operations to Catalent earlier this year, as well as clarity from the GBA in Germany indicating that an early benefit assessment would not be required. We are in active discussions with several parties for commercialization both in Europe and around the world."

"We were also pleased to see stable year-over-year quarterly sales for AMPYRA for the first time since it went generic in September 2018 and believe this is due to the strategies we have executed to maintain the brand. The strength of the AMPYRA brand is an important contributor to Acorda’s financial stability and to our goal of becoming cash-flow neutral by the end of 2022," Cohen continued. "We also plan to address our $69 million convertible debt payment that is coming due in June of 2021."

First Quarter 2021 Financial Results

For the quarter ended March 31, 2021, the Company reported INBRIJA net revenue of $5 million, compared to $4.4 million for the same quarter in 2020.

For the quarter ended March 31, 2021, the Company reported AMPYRA net revenue of $20.3 million compared to $20.1 million for the same quarter in 2020. In September 2018, AMPYRA lost its exclusivity and generics entered the market. Consequently, the Company expects AMPYRA revenue to continue to decline.

Research and development (R&D) expenses for the quarter ended March 31, 2021 were $4.7 million, including $0.2 million of share-based compensation compared to $7.7 million, including $0.4 million of share-based compensation for the same quarter in 2020.

Sales, general and administrative (SG&A) expenses for the quarter ended March 31, 2021 were $34.0 million, including $0.5 million of share-based compensation compared to $41.1 million, including $1.5 million of share-based compensation for the same quarter in 2020.

Change in fair value of derivative liability for the quarter ended March 31, 2021 was $0.2 million compared to $(26.5) million for the same quarter in 2020.

Benefit from income taxes for the quarter ended March 31, 2021 was $3.2 million compared to a benefit from income taxes of $7.0 million for the same quarter in 2020.

The Company reported a GAAP net loss of $33.5 million for the quarter ended March 31, 2021, or $3.53 per diluted share. GAAP net loss in the same quarter of 2020 was $6.5 million, or $0.81 per diluted share.

Non-GAAP net loss for the quarter ended March 31, 2021 was $23.3 million, or $2.46 per diluted share. Non-GAAP net loss in the same quarter of 2020 was $24.4 million, or $3.06 per diluted share. This quarterly non-GAAP net loss measure, more fully described below under "Non-GAAP Financial Measures," excludes share-based compensation charges, non-cash interest charges on our debt, changes in the fair value of acquired contingent consideration, asset impairment charges, changes in the fair value of derivative liability related to our 2024 convertible senior secured notes, and expenses that pertain to non-routine corporate restructurings. A reconciliation of the GAAP financial results to non-GAAP financial results is included with the attached financial statements.

At March 31, 2021, the Company had cash, cash equivalents, short-term investments, and restricted cash of $148.4 million, compared to $102.9 million at year end 2020. Restricted cash includes $31.1 million in escrow related to the 6% semi-annual interest portion, payable in cash or stock, of the 2024 convertible senior secured notes. If the Company elects to pay interest due in stock, the restricted cash will be released from escrow.

Financial Guidance

For the full-year 2021, Acorda continues to expect AMPYRA net revenue to be $75 – $85 million, and operating expenses to be $130 – $140 million. The operating expense guidance is a non-GAAP projection that excludes restructuring costs and share-based compensation as more fully described below under "Non-GAAP Financial Measures."
Webcast and Conference Call

The Company will host a conference call and webcast in conjunction with its first quarter 2021 update and financial results today at 4:30 p.m. EDT.

To participate in the Webcast/Conference Call, please note there is a new pre-registration process.

To register for the Webcast, use the link below:
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To register for the Conference Call, use the link below:
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**When registering please type your phone number with no special characters**

Once you have registered, you will receive a confirmation email with Webcast/Conference Call details. For the Webcast you will receive an email 2 hours prior to the start of the call with the link to join. The presentation will be available on the Investors section of www.acorda.com.

A replay of the call will be available from 7:30 p.m. EDT on May 6, 2021 until 11:59 p.m. EDT on June 3, 2021. To access the replay, please dial (800) 585-8367 (domestic) or (416) 621-4642 (international); reference code 2996776. The archived webcast will be available in the Investor Relations section of the Acorda website at www.acorda.com.

On May 6, 2021 Amgen (NASDAQ:AMGN) reported that it will present at the 2021 Bank of America Merrill Lynch Virtual Healthcare Conference at 11:00 a.m. ET on Tuesday, May 11, 2021 (Press release, Amgen, MAY 6, 2021, View Source [SID1234579328]). David M. Reese, M.D., executive vice president of Research and Development, Murdo Gordon, executive vice president of Global Commercial Operations and Peter H. Griffith, executive vice president and chief financial officer at Amgen, will present at the conference. Live audio of the conference call will be broadcast over the internet simultaneously and will be available to members of the news media, investors and the general public.

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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

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The webcast, as with other selected presentations regarding developments in Amgen’s business given at certain investor and medical conferences, can be accessed on Amgen’s website, www.amgen.com, under Investors. Information regarding presentation times, webcast availability and webcast links are noted on Amgen’s Investor Relations Events Calendar. The webcast will be archived and available for replay for at least 90 days after the event.