ESSA Pharma Provides Corporate Update and Reports Financial Results for Fiscal Second Quarter Ended March 31, 2020

On May 7, 2020 ESSA Pharma Inc. ("ESSA", or the "Company") (NASDAQ: EPIX, TSX-V: EPI), a pharmaceutical company focused on developing novel therapies for the treatment of prostate cancer, reported financial results for the fiscal second quarter ended March 31, 2020 (Press release, ESSA, MAY 7, 2020, View Source [SID1234557387]). All references to "$" in this release refer to United States dollars, unless otherwise indicated.

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"This past quarter has seen ESSA achieve a significant milestone as we filed the IND for EPI-7386 on time, and subsequently received allowance from the FDA to proceed with the Phase I clinical trial of EPI-7386," stated David Parkinson, MD, President and CEO of ESSA. Dr. Parkinson continued, "We are currently working with clinical sites in the US and Canada so we can begin enrollment of patients as soon as possible, ensuring compliance with COVID-19 risk management guidance as provided by the FDA."

Recent Corporate Highlights

The Investigational New Drug ("IND") application for EPI-7386 was filed and accepted by the Food and Drug Administration ("FDA"), and a clinical trial application ("CTA") was subsequently filed with Health Canada. The clinical trial is expected to enroll approximately 18 patients at multiple medical institutions in a standard 3+3 trial design with an approximate 10 additional patients enrolled in the dose expansion cohort.
Entered into an Open Market Sale Agreement (the "ATM Sales Agreement") with Jefferies LLC, effective as of April 13, 2020. Under the ATM Sales Agreement, ESSA may sell its common shares in the capital of the Company from time to time for up to US$35.0 million in aggregate sales proceeds in "at-the-market" transactions.
The Company will present posters with preclinical data on EPI-7386 at both the American Urological Association Annual Meeting to be held virtually on May 18, 2020 and the AACR (Free AACR Whitepaper) Virtual Annual Meeting II held from June 22-24th. The poster presentations will include new gene expression data for EPI-7386, enzalutamide and the combination of the two in prostate cancer models.
The ESSA management team will participate in Jefferies Virtual Healthcare Conference from June 2-4, 2020.
Summary Financial Results

Net Income (Loss). ESSA recorded a net loss of $9.4 million ($0.45 loss per common share based on 20,819,572 weighted average common shares outstanding) for the quarter ended March 31, 2020, compared to a net loss of $3.4 million ($0.54 loss per common share based on 6,311,098 weighted average common shares outstanding) for the quarter ended March 31, 2019. This included non-cash share-based payments of $3.6M for the quarter ended March 31, 2020 compared to $316,407 for the quarter ended March 31, 2019, recognized for stock options granted and vesting.

Research and Development ("R&D") expenditures. R&D expenditures for the quarter ended March 31, 2020 were $4.6 million compared to $1.5 million for the quarter ended March 31, 2019. The increase in R&D expenditures for the quarter were primarily related to preparing the IND application for EPI-7386, preparatory clinical costs, manufacturing and chemistry costs, and non-cash costs related to share-based payments ($1.03M for quarter ending March 31, 2020 compared to $92,851 for quarter ended March 31, 2019). R&D costs in the comparative period were primarily related to preclinical research of the Company’s next-generation aniten compounds.

General and administration ("G&A") expenditures. G&A expenditures for the quarter ended March 31, 2020 were $4.9 million compared to $1.8 million for the quarter ended March 31, 2019. The increase in the quarter is primarily due to non-cash share-based payments. ($2.55M for the quarter ending March 31, 2020 compared to $223,556 for the quarter ending March 31, 2019.)
Liquidity and Outstanding Share Capital

Cash on hand at March 31, 2020 was $39.9 million, with working capital of $39.7 million, reflecting the aggregate gross proceeds of the August 2019 financing of $36 million and the acquisition of Realm Therapeutics plc which provided the Company with $22.2 million in cash, less operating expenses in the intervening period.

As of March 31, 2020, the Company had 20,824,339 common shares issued and outstanding.

In addition, as of March 31, 2020 there were 12,331,127 common shares issuable upon the exercise of warrants and broker warrants. This includes 11,919,404 prefunded warrants at an exercise price of $0.0001 that were issued in lieu of common shares in the August 2019 financing, and 411,723 other warrants at a weighted average exercise price of $38.93. There are 5,310,000 common shares issuable upon the exercise of outstanding stock options at a weighted-average exercise price of $3.41 per common share.

Bridge Biotherapeutics Announces the IND Clearance of BBT-176, an EGFR TKI for NSCLC, in South Korea

On May 7, 2020 Bridge Biotherapeutics Inc.(KOSDAQ: 288330), a clinical stage biotech company headquartered in Seongnam, Republic of Korea, reported that the Investigational New Drug (IND) application of BBT-176 submitted to South Korea’s Ministry of Food and Drug Safety (MFDS) was officially cleared on May 7th (Press release, BridgeBio, MAY 7, 2020, View Source [SID1234557364]).

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BBT-176, a novel epidermal growth factor receptor-tyrosine kinase inhibitor (EGFR-TKI) is designed to inhibit the signaling pathway of EGFR with C797S mutations, which arise as Tagrisso (osimertinib) resistant mutations following Tagrisso treatment in non-small cell lung cancer (NSCLC). The mutation results in a cysteine to serine change in the 797 position of the kinase domain sequence of the EGFR. During pre-clinical studies, BBT-176 exhibited strong anti-tumor efficacy in C797S triple mutations. Additionally, BBT-176 displayed markedly enhanced efficacy when combined with anti-EGFR antibodies.

On IND clearance in South Korea, Bridge Biotherapeutics plans to initiate a dose escalation study as the first part of the phase I/II study in Korea to find the maximum tolerable dose (MTD), the recommended phase 2 dose (RP2D) and to observe safety, tolerability and the anti-tumor efficacy of BBT-176 in a group of patients with advanced NSCLC. After completing the dose escalation study, a dose expansion study will be initiated in both the U.S. and South Korea. During this study, the company will assess the safety, tolerability and efficacy along with the RP2D of the drug candidate.

Under the study protocol, approximately 90 patients are expected to be included in the Phase I/II study of BBT-176. The company will also observe detailed anti-tumor efficacy in the combination therapy of BBT-176 with anti-EGFR antibodies.

"We are greatly encouraged by the IND clearance of BBT-176 in South Korea," and "Bridge will continue to focus on bringing new treatment options for patients in need of a novel NSCLC therapy," said James Lee, CEO of Bridge Biotherapeutics.

BBT-176 was discovered by the Korea Research Institute of Chemical Technology (KRICT), a Korean government research institute. The global exclusive rights for further development was licensed to Bridge Biotherapeutics in December 2018. Since the US FDA cleared the IND application of BBT-176 in January 2020, Bridge Biotherapeutics has been in continuous discussions with global and local pharmaceuticals and biotech companies regarding potential business alliance opportunities.

Lung cancer is the leading cause of cancer death, accounting for about one-fifth of all cancer deaths. It is divided into NSCLC and small cell lung cancer (SCLC) and NSCLC accounts for approximately 85% of all lung cancers. Overall, across the 8 major countries including the U.S., 5 EU countries, China and Japan, the total NSCLC population as of 2015 is assumed 2 million and the incidence of NSCLC is expected to increase at an annual growth rate of 3.1% from 2015 to 2025.[i]

Cryoport Revenue Grows 47% for First Quarter 2020

On May 7, 2020 Cryoport, Inc. (NASDAQ: CYRX) (NASDAQ: CYRXW) ("Cryoport"), a global leader in life sciences solutions, reported financial results for the three-month period ended March 31, 2020 (Press release, Cryoport, MAY 7, 2020, View Source [SID1234557363]).

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"We reported revenue of $9.8 million for the First Quarter of 2020, an increase of 47% from the First Quarter of 2019," said Jerrell Shelton, Chief Executive Officer of Cryoport. "This was driven largely by record revenue from our commercial agreements supporting Gilead’s YESCARTA and Novartis’ KYMRIAH which contributed $2.9 million to the First Quarter of 2020, representing an increase of 110% compared with the First Quarter of 2019. In the first quarter, we experienced minimal disruption of our commercial portfolio resulting from the COVID-19 pandemic and are working closely with our partners to ensure eligible patients continue to have access to these life-saving therapies.

"In April, Gilead’s Kite Pharma renewed its agreement with Cryoport, which cover its entire portfolio of therapies in development as well as YESCARTA. The ongoing rollouts of both YESCARTA and KYMRIAH to patients in the Americas, EMEA and APAC are expected to drive a continued ramp in activity related to our agreements supporting these commercial products. Revenue from our agreement with bluebird bio to support its commercial launch of ZYNTEGLO is expected to commence in the second half of 2020."

"Our revenue growth in the First Quarter was also attributable to Cryogene, our Houston based Bioservices operation, which contributed revenue of $1.3 million. Cryogene specializes in the long-term secure storage of biological specimens, materials and samples for research purposes and is expected to continue to operate with some, but relatively minimal, impact from the COVID-19 pandemic.

"We are very pleased to report strong clinical trial growth for the quarter as we added a net total of 29 clinical trials, bringing the total number of clinical trials supported by Cryoport to a record 465.

"As providers of mission-critical logistics solutions to the healthcare industry, we are actively monitoring the spread of COVID-19 and continue to operate our Global Logistics Center Network with minimal impact on our ability to conduct day-to-day operations for our life sciences clients. While a meaningful number of the clinical trials we support have been suspended temporarily, none of these trials, to our knowledge, have been terminated as a result of COVID-19. These suspensions did impact our clinical trial revenue in late First Quarter and that impact continues into the Second Quarter of 2020. For trials that are ongoing, we are supporting our clients’ needs effectively and with business continuity plans in place to limit disruption and minimize any potential risk to our employees. We believe the structural shift that is underway in the biopharma market toward large-molecule treatments plays to our strengths as these therapies require much more rigorous, specialized and temperature sensitive logistics and storage solutions that meet exacting requirements. We think these requirements and our ever-increasing competency in tailored information technology will ensure the continued medium- and long-term expansion of our business despite the near-term headwinds we are experiencing from COVID-19.

Two Cryoport supported therapies filed for commercial approval during the First Quarter of 2020, and a third filed subsequent to the quarter end. We continue to expect a further six Cryoport supported MAA’s and BLA’s to be filed in 2020, based on internal information and forecasts from the Alliance for Regenerative Medicine, although the timing of some of these may be impacted by COVID-19.

"We are the life sciences industry leader in temperature-controlled logistics and biostorage of life-saving advanced cell and gene therapies, vaccines and other fragile and high value commodities, providing essential and highly specialized solutions to the Biopharma market. With research into COVID-19 moving at a relatively rapid pace, we have been selected to support six clinical trials for potential COVID-19 treatments and vaccines. We are proud to use our expertise to contribute to the fight against the spread of COVID-19 and are working closely with our clients to assure the security of their products as they advance the trials of these much-needed therapies.

"The Reproductive Medicine market was impacted by COVID-19 imposed restrictions and, consequently, for the First Quarter of 2020 contributed revenue of $0.8 million. Upon the lifting of these restrictions, we will resume our services and believe we will be well-positioned to drive revenue growth in this market. One example that gives us confidence is our new multi-year agreement with Inception Fertility, LLC, a Houston-based company which operates The Prelude Network, the largest and fastest growing network of fertility centers in the United States.

Mr. Shelton concluded by saying, "Our strong balance sheet and liquidity position, along with long-term agreements with an exceptionally loyal client base and successfully implemented business mitigation plans, gives us confidence in our ability to navigate the uncertainties caused by the pandemic. We are confident in our future and continue to execute on our plans to support the anticipated expansion in demand for our cutting-edge supply chain solutions. This entails building out our infrastructure, including software, competencies, and further expanding our Global Supply Chain Network, with new Global Supply Chain Centers in Morris Plains, New Jersey and Houston, Texas. We also continue to evaluate potential M&A opportunities that are complementary, accretive and expand our solutions offerings and total addressable market."

Market Highlights:

Global Logistics Solutions

Biopharma

Biopharma revenue increased by 33% in the three-months ended March 31, 2020 compared to the same period in 2019.
Commercial revenue increased $1.5 million, or 110%, to $2.9 million for the three months ended March 31, 2020, as compared to $1.4 million for the same period in 2019.
Cryoport is now supporting a net total of 465 clinical trials as of March 31, 2020 compared with 383 as of March 31, 2019. The number of trials in Phase III grew to 62, compared with 49 as of March 31, 2019. Of the 465 total trials Cryoport supports, 384 are in the Americas, 65 in EMEA (Europe, the Middle East and Africa) and 16 in APAC (Asia Pacific). This compares to 338 in the Americas and 45 in EMEA as of March 31, 2019.
Gilead Sciences, Inc.’s subsidiary, Kite Pharma ("Kite"), renewed its agreement with Cryoport for an additional three years with evergreen provisions. The agreement covers all therapies in Kite’s portfolio, including the continued commercial rollout of its lead chimeric antigen receptor (CAR) T-cell therapy for the treatment of aggressive Non-Hodgkin Lymphoma, YESCARTA, all ongoing clinical programs as well as any new commercial product launches.
Selected by Cellular Biomedicine Group, Inc. (Nasdaq: CBMG), a developer of proprietary cell therapies for the treatment of cancer and degenerative diseases, to support two of its immuno-oncology and stem cell clinical trials in China.
Animal Health

Animal Health revenue remained flat at $0.2 million for both the three months ended March 31, 2020 and the three-months ended March 31, 2019; however, we are building a strong pipeline of potential clients and expect to grow Animal Health revenue in 2020.
Reproductive Medicine

As a result of the impact of COVID-19, Reproductive Medicine revenue remained relatively flat at $0.8 million for both the three months ended March 31, 2020 and the three months ended March 31, 2019.
Cryoport entered into a multi-year agreement with Inception Fertility, LLC, a Houston-based company which operates The Prelude Network, the largest and fastest growing network of fertility centers in the United States.
Global Bioservices

Bioservices revenue was $1.3 million for the three-month period ended March 31, 2020 resulting from the acquisition of Cryogene consummated in May 2019.
Financial Highlights:

Revenue increased 47% to $9.8 million for the three-month period ended March 31, 2020, compared with the same period in the prior year.
Excluding revenue from the Cryogene acquisition in May of 2019, revenue grew 28% for the three-month period ended March 31, 2020, compared with the same period in the prior year.
Gross margin for the three-months ended March 31, 2020 was 54%, compared to 52% for the same period in the prior year.
Operating costs and expenses increased by $3.2 million for the three-month period ended March 31, 2020, compared to the same period in the prior year, as a result of continued investments in software development, which will provide a platform for continuing the scaling of our business; engineering initiatives, which includes the development of revolutionary packaging and monitoring and communications resources and the build out competencies in support of advancing our infrastructure and the growing demand for Cryoport’s solutions.
Adjusted EBITDA for the three-month period ended March 31, 2020 was ($1.7 million), compared with ($0.4 million) in the same period in the prior year.
Net loss for the three-month period ended March 31, 2020 was $3.9 million, or $0.11 per share, compared to a net loss of $2.4 million, or $0.08 per share in the same period in 2019.
Cryoport reported $97.4 million in cash, cash equivalents and short-term investments as of March 31, 2020, compared with $94.3 million as of December 31, 2019.
Further information on Cryoport’s financial results is included on the attached condensed consolidated balance sheets and statements of operations, and additional explanations of Cryoport’s financial performance are provided in Cryoport’s annual report on Form 10-Q for the three months ended March 31, 2020, which will be filed with the Securities and Exchange Commission ("SEC") on or about May 8, 2020. The full report will be available on the SEC Filings section of the Investor Relations section of Cryoport’s website at www.cryoport.com.

Earnings Conference Call Information

IMPORTANT INFORMATION: A document titled "Cryoport First Quarter 2020 in Review", providing a review of Cryoport’s recent financial and operational performance and a general business update, will be issued at 4:05 pm ET on Thursday, May 7, 2020. The document is designed to be read by investors before the questions and answers conference call and can be accessed at http://ir.cryoport.com/events-and-presentations.

Cryoport management will host a conference call at 5:00 pm ET on May 7, 2020. The conference call will be in the format of a questions and answers session and will address any queries investors have regarding the Company’s reported results.

Conference Call Information

Date:

May 7, 2020

Time:

5:00 p.m. ET

Dial-in numbers:

+1 (855) 327-6837 (U.S.), +1 (631) 891-4304 (International)

Confirmation code:

Request the "Cryoport Call"

Live webcast:

‘Investor Relations’ section at www.cryoport.com or at this link. Please allow 10 minutes prior to the call to visit this site to download and install any necessary audio software.

Questions and answers will be recorded and available approximately three hours after completion of the live event on the Investor Relations section of the Company’s website at www.cryoport.comfor a limited time. To access the replay of the questions and answers, please follow this link. A dial-in replay of the call will also be available, to those interested, until May 14, 2020. To access the replay, dial +1 (844) 512-2921 (United States) or +1 (412) 317-6671 (International) and enter replay pin number: 10009027.

GRAIL to Participate in BofA Securities 2020 Health Care Conference

On May 7, 2020 GRAIL, Inc., a healthcare company whose mission is to detect cancer early, when it can be cured, reported executives will be speaking at the BofA Securities 2020 Health Care Conference (Press release, Grail Bio, MAY 7, 2020, View Source [SID1234557362]).

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Hans Bishop, Chief Executive Officer, and Joshua Ofman, MD, MSHS, Chief Medical Officer and External Affairs, will provide an overview of the company at the virtual conference on Wednesday, May 13, 2020, at 5:00 p.m. ET.

A live and archived audio webcast of the event may be accessed at the link below.

http://www.veracast.com/webcasts/bofa/healthcare2020/id17109109.cfm

Verastem Oncology Reports First Quarter 2020 Financial Results and Highlights Recent Company Progress

On May 7, 2020 Verastem, Inc. (Nasdaq:VSTM) (also known as Verastem Oncology), a biopharmaceutical company committed to developing and commercializing new medicines for patients battling cancer, reported financial results for the three months ending March 31, 2020, and provided an overview of recent corporate highlights (Press release, Verastem, MAY 7, 2020, View Source [SID1234557361]).

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"The early part of 2020 was marked most importantly by the strategic in-licensing of the novel RAF/MEK inhibitor VS-6766 which is being investigated in combination with defactinib, our lead FAK inhibitor, in KRAS mutant tumors," commented Brian Stuglik, Chief Executive Officer of Verastem Oncology. "The encouraging preliminary Phase 1 results from the investigator-initiated FRAME study recently reported at AACR (Free AACR Whitepaper) in KRAS mutant low-grade serous ovarian cancer (LGSOC) will form the basis of our upcoming discussions with the U.S. Food and Drug Administration (FDA) and other regulatory authorities. We look forward to identifying the path forward for this novel combination and to embarking on a registration-directed clinical trial in LGSOC as rapidly as possible."

RAF/MEK and FAK Inhibition in KRAS Mutant Solid Tumors

Presented Preliminary Results from investigator-initiated Phase 1 FRAME Study Investigating the Combination of VS-6766 and Defactinib in KRAS Mutant Solid Tumors at AACR (Free AACR Whitepaper) 2020 Virtual Meeting I. In a virtual poster presentation, Udai Banerji, MBBS, MD, DNB, PhD, FRCP, NIHR, Professor of Molecular Cancer Pharmacology at The Institute of Cancer Research and Honorary Consultant in Medical Oncology at The Royal Marsden NHS Foundation Trust, highlighted data from this ongoing, open-label, dose-escalation and expansion investigator-initiated study investigating the combination of VS-6766, Verastem Oncology’s RAF/MEK inhibitor, with defactinib, the Company’s FAK inhibitor, in patients with KRAS mutant advanced solid tumors, including LGSOC and non-small cell lung cancer (NSCLC).

The VS-6766/defactinib combination was well tolerated by the patients in the trial. The recommended Phase 2 dose has now been established. In the patients with KRAS mutant LGSOC (n=6), 4 patients responded for an overall response rate (ORR) of 67%. The median time on treatment for these 4 patients was 20.5 months. In the patients with KRAS mutant NSCLC (n=10), 1 patient responded (partial response) for an ORR of 10% and a total of 8 patients achieved disease control for a disease control rate (DCR) of 80%. Additionally, in patients with KRAS mutant NSCLC, 8 remained on therapy for at least 12 weeks and 3 remained on therapy for at least 24 weeks. Expansion cohorts remain ongoing in LGSOC and NSCLC.

Verastem Oncology plans to initiate discussions with the FDA during second quarter of 2020, with the goal of commencing a registration-directed clinical trial investigating the VS-6766/defactinib combination in patients with LGSOC by the end of 2020.

Subsequent Analysis

Based on an observation of higher response rates seen in patients with KRASG12V mutations in the investigator-initiated Phase 1 combination study, Verastem Oncology conducted a post-hoc combined analysis with data from the combination study and the prior single-agent study that utilized a twice-weekly dosing schedule of VS-6766 to get a more complete picture of activity in KRASG12V mutations. This analysis showed early signals of activity in patients with KRASG12V mutated NSCLC. The Company plans to evaluate this finding further in a prospective NSCLC clinical trial.
New Strategic Direction. Verastem Oncology recently licensed exclusive global development and commercialization rights to VS-6766 (CH5126766), a unique and promising inhibitor of the RAF/MEK signaling pathway. The Company then announced its plans to accelerate development of VS-6766 in combination with defactinib for the treatment of KRAS mutant solid tumors. The rationale for investigating the combinations of VS-6766 and defactinib is supported by single-agent Phase 1 and Phase 2 studies which investigated defactinib in KRAS mutant NSCLC1 and VS-6766 in KRAS mutant NSCLC and LGSOC2.
COPIKTRA (Duvelisib)

First Patient Dosed in Chinese Study Evaluating Duvelisib in Patients with Relapsed or Refractory Follicular Lymphoma (FL). Verastem Oncology’s partner, CSPC Pharmaceutical Group Limited, has dosed the first patient in a single-arm, open-label, multi-center pivotal study designed to evaluate the antitumor activity and safety of duvelisib in patients with relapsed or refractory FL. This study is expected to serve as a bridging study based on the efficacy and safety observed in Verastem Oncology’s Phase 2 DYNAMO study. The results of this study will form the basis of a regulatory submission for duvelisib for the treatment of relapsed or refractory FL in China.
Ongoing U.S. Commercial Rollout of COPIKTRA. COPIKTRA, the Company’s marketed oral inhibitor of phosphoinositide 3-kinase (PI3K), and the first FDA-approved dual inhibitor of PI3K-delta and PI3K-gamma generated $5.0 million in net product revenues during the first quarter of 2020, a 194% increase over the first quarter of 2019 and a 39% increase over the fourth quarter of 2019.
Corporate and Financial

Strengthened the Balance Sheet Through a Private Placement with Premier Life Science Investors. On March 3, 2020, Verastem Oncology completed a private placement offering of approximately 46.5 million shares of its common stock to certain institutional investors, including RA Capital Management, Vivo Capital, Venrock Healthcare Capital Partners, Farallon Capital Management, Acuta Capital, EcoR1 Capital LLC, Avidity Partners and Logos Capital at a price of $2.15 per share, a 12.6% premium to the February 27, 2020 closing price. The gross proceeds to Verastem Oncology were $100 million. After deducting the underwriting discounts and commissions and other estimated offering expenses, net proceeds to the Company were approximately $93.8 million.
Convertible Senior Second Lien Notes (2019 Notes) Fully Converted to Common Stock. During the first quarter of 2020, all of the remaining 2019 Notes were converted into shares of common stock. As of March 31, 2020, the Company had approximately $63.3 million in outstanding debt.
Appointed John H. Johnson to the Board of Directors. In April, Verastem Oncology announced the appointment of John H. Johnson to its Board of Directors. Mr. Johnson’s career spans multiple executive management roles at leading global corporations where he was responsible for overseeing oncology and immunology drug development initiatives and commercialization. Mr. Johnson will serve on the Compensation and Nominating and Governance Committees.
First Quarter 2020 Financial Results

Net product revenue for the three months ending March 31, 2020 (2020 Quarter) was $5.0 million, compared to $1.7 million for the three months ending March 31, 2019 (2019 Quarter). COPIKTRA demand units for the 2020 Quarter increased 178% compared to the 2019 Quarter. License and collaboration revenue for the 2020 Quarter was less than $0.1 million. There was no license and collaboration revenue for the 2019 Quarter. 2020 Quarter license and collaboration revenue was comprised of duvelisib shipments to our partner, CSPC Pharmaceutical Group Limited.

Total operating expenses for the 2020 Quarter were $31.4 million, compared to $36.3 million for the 2019 Quarter. Included within operating expenses for the 2020 Quarter is a non-recurring charge of $3.0 million related to an up-front non-refundable payment to Chugai Pharmaceutical Co. Ltd. (Chugai) for the VS-6766 license, $1.8 million of severance expense and $1.4 million of non-cash stock-based compensation expense.

Research and development (R&D) expense for the 2020 Quarter was $10.9 million, compared to $9.8 million for the 2019 Quarter. The increase of $1.1 million, or 11%, was primarily related to the up-front non-refundable payment of $3.0 million to Chugai for the VS-6766 license. This was partially offset by a decrease of $1.3 million in contract research organization costs and a decrease of $0.6 million in costs for clinical supply, drug substance and drug product.

Selling, general and administrative (SG&A) expense for the 2020 Quarter was $19.6 million, compared to $26.0 million for the 2019 Quarter. The decrease of $6.4 million, or 25%, primarily resulted from a decrease of $2.8 million in consulting and professional fees, principally related to the support of commercial launch activities in the 2019 Quarter, a decrease of $2.3 million in personnel related costs, including non-cash stock-based compensation as a result of reduced headcount, and a decrease of $1.3 million in reduced travel and other costs.

Net loss for the 2020 Quarter was $38.0 million, or $0.35 per share (basic and diluted), compared to $38.1 million, or $0.52 per share (basic and diluted), for the 2019 Quarter. The 2020 Quarter includes $8.1 million of non-cash interest expense related to conversions of Convertible Senior Notes into shares of common stock.

For the 2020 Quarter, non-GAAP adjusted net loss was $21.3 million, or $0.20 per share (diluted), compared to non-GAAP adjusted net loss of $33.8 million, or $0.46 per share (diluted), for the 2019 Quarter. Please refer to the GAAP to Non-GAAP Reconciliation attached to this press release.

Verastem Oncology ended the first quarter of 2020 with cash, cash equivalents and short-term investments of $170.7 million.

Financial Guidance for Fiscal 2020

As a result of its new strategic direction, Verastem Oncology expects to reduce its operating expenses by approximately 40% for 2020 compared to 2019. Based on its current operating plans, the Company expects its R&D and SG&A expenses for the full year 2020 to be in the range of $70 million to $85 million. The company is guiding that 2020 COPIKTRA revenues may be approximately $16 million.