On April 30, 2020 ANI Pharmaceuticals, Inc. (NASDAQ: ANIP) reported that the Company plans to release its first quarter 2020 financial results on Thursday, May 7, 2020, before the opening of the U.S. financial markets (Press release, ANI Pharmaceuticals, APR 30, 2020, View Source [SID1234556877]). The earnings press release will be accessible through the Investor Relations section of the Company’s website, www.anipharmaceuticals.com.

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Arthur S. Przybyl, President and Chief Executive Officer, and Stephen P. Carey, Vice President, Finance, and Chief Financial Officer, also plan to host a conference call to review those results starting at 10:30am Eastern Time on Thursday, May 7, 2020. The call will be open to the public and can be accessed through a conference line by dialing (866) 776-8875. The conference ID is 5243607.

A recording of the conference call will be available within two hours of the completion of the call and will remain accessible for a period of seven days following the call. To access the replay, dial (800) 585-8367. The access code for the replay is 5243607.

On April 30, 2020 ViewRay, Inc. (Nasdaq: VRAY) reported financial results for the first quarter ended March 31, 2020 (Press release, ViewRay, APR 30, 2020, View Source [SID1234556876]).

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First Quarter 2020 Highlights:

Total revenue of $14.3 million, primarily from three revenue units including one system upgrade, compared to $20.3 million, primarily from four revenue units including one system upgrade, in the first quarter of 2019.
Received four new orders for MRIdian systems totaling $22.6 million, compared to seven new orders totaling $42.8 million in the first quarter of 2019.
Total backlog was $230.8 million as of March 31, 2020, compared to $237.5 million as of March 31, 2019.
Cash and cash equivalents were $190.2 million as of March 31, 2020.
The Company is withdrawing its 2020 guidance, provided on March 12, 2020, as the full impact of COVID-19 remains unknown.
The Company announced Zach Stassen as Chief Financial Officer.
"As we manage in this challenging environment, we are focused on what we can control. Value creation lies in driving our clinical, innovation and commercial pipeline while enhancing efforts to conserve capital," said Scott Drake, President and CEO. "On another important note, we are excited to welcome Zach Stassen as our Chief Financial Officer. Zach has an excellent track record as an operator and CFO in the medical technology space. I’d like to thank our Interim-CFO, Brian Knaley, for his work to drive the business forward over the last several quarters."

First Quarter 2020 Financial Results:

Total revenue for the three months ended March 31, 2020 was $14.3 million compared to $20.3 million for the same period last year.

Total cost of revenue for the three months ended March 31, 2020 was $16.4 million compared to $25.6 million for the same period last year. Total cost of revenue in the first quarter of 2019 was impacted by approximately $7.0 million of charges, primarily driven by higher than anticipated installation costs related to historical upgrade commitments.

Total gross profit (loss) for the three months ended March 31, 2020 was $(2.1) million, compared to $(5.4) million for the same period last year.

Total operating expenses for the three months ended March 31, 2020 were $27.9 million, compared to $25.0 million for the same period last year.

Net loss for the three months ended March 31, 2020 was $27.5 million, or $0.19 per share, compared to $33.4 million, or $0.34 per share, for the same period last year.

ViewRay had total cash and cash equivalents of $190.2 million at March 31, 2020.

Financial Guidance

Given the existing uncertainty related to COVID-19 globally, the Company is withdrawing 2020 guidance, issued on March 12, 2020, as the full impact of coronavirus remains unknown.

Conference Call and Webcast

ViewRay will hold a conference call to discuss results on Thursday, April 30, 2020 at 4:30 p.m. ET / 1:30 p.m. PT. The dial-in numbers are (844) 277-1426 for domestic callers and (336) 525-7129 for international callers. The conference ID number is 8982097. A live webcast of the conference call will be available on the investor relations page of ViewRay’s corporate website at www.viewray.com.

After the live webcast, a replay of the webcast will remain available online on the investor relations page of ViewRay’s corporate website, www.viewray.com, for 14 days following the call. In addition, a telephonic replay of the call will be available until May 7, 2020. The replay dial-in numbers are (855) 859-2056 for domestic callers and (404) 537-3406 for international callers. Please use the conference ID number 8982097.

On April 30, 2020 PTC Therapeutics, Inc. (NASDAQ: PTCT) reported a corporate update and reported financial results for the first quarter ending March 31, 2020 (Press release, PTC Therapeutics, APR 30, 2020, View Source [SID1234556875]).

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"PTC continued to execute on our strategic priorities including the development and commercial fronts in the first quarter highlighted by DMD franchise revenue growth and strong risdiplam results," said Stuart Peltz, Ph.D., CEO of PTC Therapeutics. "The breadth of positive clinical risdiplam data reinforces the global commercial competitive profile of this therapy, which has the potential to be the first and only at-home SMA treatment, a critical advantage in the COVID-19 environment. We look forward to a number of potential value-creating catalysts including the risdiplam PDUFA date, and multiple clinical milestones in the upcoming months."

Key First Quarter and Other Corporate Updates:

Total net product revenues were $68.2 million across our commercial portfolio in the first quarter of 2020 representing 28% year over year growth. Translarna (ataluren) net product revenues were $40.5 million for the first quarter of 2020 and Emflaza (deflazacort) net product revenues were $27.5 million for the first quarter of 2020.
PTC announced the appointments of Matthew Klein, M.D., to Chief Development Officer and Eric Pauwels to Chief Business Officer.
Due to the uncertainty of the duration and severity of the COVID-19 impact, PTC is withdrawing financial guidance for the 2020 fiscal year.
Compelling Data Across Patients with Type 1, 2 & 3 SMA

The FIREFISH Part 2 data in type 1 Spinal muscular atrophy (SMA) patients demonstrated achievement of motor milestones and motor function improvements not observed in natural history. The study met its primary endpoint (p<0.0001), with 12 of 41 patients sitting, and all of its key secondary endpoints. Safety data was consistent with the known safety profile. There were no new safety signals and risdiplam was generally well tolerated.
The clinical data from Part 2 of the pivotal SUNFISH study evaluating risdiplam in people aged 2-25 years with non-ambulatory type 2 and type 3 SMA demonstrated statistically significant results in primary and key secondary endpoints. Safety for risdiplam was consistent with its known safety profile and no new safety signals were identified.
Risdiplam clinical studies are ongoing, including RAINBOWFISH and JEWELFISH. When necessary, patients are receiving drug through contactless home delivery to ensure study compliance.
Earlier this year, Roche opened early access programs in the United States (U.S.) and European countries for type 1 SMA patients. Recently, Roche announced that the program will be expanded to include patients with type 2 SMA in countries where applicable, at the moment of filing of the regulatory application for risdiplam. In addition, in response to requests received as well as to the unique pressures of the COVID-19 pandemic, Roche has decided to amend the programs for type 1 and type 2 patients whose current treatment have been interrupted as a direct consequence of the COVID-19 pandemic. The Prescription Drug User Fee Act (PDUFA) date for risdiplam is now August 24, 2020, following the submission of additional data including SUNFISH Part 2.
Advancing Gene Therapy Platform

PTC now expects to file the biologics license application (BLA) submission with the U.S. Food and Drug Administration (FDA) in the second half of 2020 for its gene therapy program for Aromatic L-amino acid decarboxylase (AADC) deficiency. The study of the use of the commercial cannula in young patients has been delayed due to COVID-19.
The Marketing Authorization Application (MAA) process in the European Union (EU) for the AADC deficiency program is ongoing and PTC expects to receive the Committee for Medicinal Products for Human Use (CHMP) final opinion by the end of 2020.
For our Friedreich ataxia (FA) and Angelman syndrome gene therapy programs, COVID-19 has impacted multiple investigational new drug application (IND) enabling activities. Therefore, we now anticipate the IND filings will be delayed by at least one quarter and we will provide an update on timing as we better understand the impact of COVID-19.
Due to COVID-19, PTC has deferred certain capital expenditures related to our leased biologics facility in Hopewell Township, New Jersey and now anticipates that GMP manufacturing of clinical material at this facility will begin in early 2021.
Updates in PTC’s Diverse Product Pipeline

PTC now anticipates results from the U.S. Translarna dystrophin study in the third quarter of 2020. Due to COVID-19, the study site is currently closed to elective procedures, which includes those required to complete the dystrophin study.
The Huntington disease program remains on track to be in healthy volunteers prior to the end of 2020. A development candidate has been chosen and IND toxicology studies are ongoing.
PTC now expects to initiate potential registrational trials in its Bio-e platform with PTC743 in refractory mitochondrial epilepsy in the third quarter of 2020 and in Friedreich ataxia in the fourth quarter of 2020. The initiation of these studies has been delayed due to COVID-19.
The Phase 1 trial of PTC857, which is being developed for GBA Parkinson’s disease, remains on track to start in the third quarter, with no current delays due to COVID-19.
In the interest of the health and safety of employees and guests, PTC has postponed the Analyst Day previously scheduled for mid-June. We plan to host virtual deep dives on our platforms throughout the year.
Financial Highlights:

Total revenues were $68.3 million for the first quarter of 2020, compared to total revenues of $53.6 million for the first quarter of 2019.
Translarna net product revenues were $40.5 million for the first quarter of 2020, compared to $35.3 million for the first quarter of 2019. These results reflect an increase in net product sales in existing markets as well as continued geographic expansion into new territories.
Emflaza net product revenues were $27.5 million for the first quarter of 2020, compared to $17.8 million for the first quarter of 2019. These results reflect new patient growth driven in part by diagnostic and educational efforts as well as ongoing operational improvements.
Generally accepted accounting principles in the United States (GAAP) research and development (R&D) expenses were $90.1 million for the first quarter of 2020, compared to $52.6 million for the first quarter of 2019. The increase in R&D expenses reflects costs associated with advancing the gene therapy and Bio-e platforms and increased investment in research programs as well as advancements of the clinical pipeline.
Non-GAAP R&D expenses were $81.9 million for the first quarter of 2020, excluding $8.2 million in non-cash stock-based compensation expense, compared to $47.9 million for the first quarter of 2019, excluding $4.7 million in non-cash stock-based compensation expense.
GAAP selling, general and administrative (SG&A) expenses were $58.2 million for the first quarter of 2020, compared to $40.6 million for the first quarter of 2019, reflecting continued investment to support our commercial activities including our expanding commercial portfolio.
Non-GAAP SG&A expenses were $51.2 million for the first quarter of 2020, excluding $7.0 million in non-cash stock-based compensation expense, compared to $36.0 million for the first quarter of 2019, excluding $4.6 million in non-cash stock-based compensation expense.
Change in the fair value of deferred and contingent consideration was $0.9 million for the first quarter of 2020, compared to $21.2 million for the first quarter of 2019. The change in fair value of deferred and contingent consideration is related to the fair valuation of potential future consideration to be paid to former equity holders of Agilis Biotherapeutics, Inc. (Agilis) in connection with PTC’s acquisition of Agilis, which closed in August 2018.
In discussions with certain former shareholders of Agilis, PTC has agreed to exchange their pro rata share of specific future cash milestone payments in the aggregate amount of $225 million for a mixture of cash and equity. Under this agreement, which the former shareholders and PTC entered into on April 29th, PTC has pre-paid 94% of time-based cash milestones due in August 2020, and has agreed to issue 2,821,176 shares of common stock in exchange for 94% of future cash milestones for the AADCd BLA approval by the FDA and the receipt of a Priority Review Voucher in connection with that approval.
Net loss was $112.7 million for the first quarter of 2020, compared to net loss of $72.1 million for the first quarter of 2019.
Cash, cash equivalents and marketable securities totaled $595.9 million at March 31, 2020, compared to $686.6 million at December 31, 2019.
Shares issued and outstanding as of March 31, 2020 were 62,758,520.
Due to the uncertainty with respect to the duration, nature and extent of impacts of the COVID-19 pandemic and responsive measures relating thereto, we cannot be certain that the pandemic will not cause us to experience further delays to the timelines set forth above or other negative additional impacts.

Today’s Conference Call and Webcast Reminder:
Today’s conference call will take place at 4:30 pm (ET) and can be access by dialing (877) 303-9216 (domestic) or (973) 935-8152 (international) five minutes prior to the start of the call and providing the passcode 8267466. A live, listen-only webcast of the conference call can be accessed on the investor relations section of the PTC website at www.ptcbio.com. The accompanying slide presentation will be posted on the investor relations section of the PTC website. A webcast replay of the call will be available approximately two hours after completion of the call and will be archived on the company’s website for 30 days following the call.

On April 30, 2020 CryoLife Reported that First Quarter 2020 Financial Results (Press release, CryoLife, APR 30, 2020, View Source [SID1234556874])

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First Quarter and Recent Business Highlights:

Achieved total revenues of $66.4 million in the first quarter 2020 versus preliminary first quarter 2020 revenues of $65.5 million
Total revenues decreased 2% and decreased 1% on a constant currency basis versus first quarter 2019
Excluding TMR, total revenues increased 1% and increased 2% on a constant currency basis versus first quarter of 2019
Received CE Mark for our Frozen Elephant Trunk E-vita OPEN NEO
Received renewed CE Mark status for our AAP Ascending Aortic Prosthesis
Secured Credit Facility Covenant Modification to Enhance Liquidity
CryoLife, Inc. (NYSE: CRY), a leading cardiac and vascular surgery company focused on aortic disease, announced today its financial results for the first quarter ended March 31, 2020.

"During these challenging times, we are focused on protecting our employees’ health and safety while continuing to supply our customers and patients who depend on our life saving and life sustaining products," commented Pat Mackin, Chairman, President, and Chief Executive Officer. "Our business is well suited to weather the impact of this global pandemic given the nature of the procedures in which our products are used. Our manufacturing facilities have been running at near capacity and our supply chain remained largely intact. We have continued to fund R&D programs related to products that could deliver revenue in 2021 and 2022, including our U.S. PerClot PMA, BioGlue China and PROACT Mitral. Further, we renegotiated our Credit Facility covenant to have greater financial flexibility, if necessary. Given our recent device approvals, and the ongoing progress made on our key growth initiatives, we expect 2021 to be a strong year for CryoLife."

First Quarter 2020 Financial Results
Total revenues for the first quarter of 2020 were $66.4 million, reflecting a decrease of (2%), and (1%) on a non-GAAP constant currency basis, both compared to the first quarter of 2019. Growth in tissue processing and On-X revenues was offset by decreases in BioGlue and JOTEC revenues.

Net loss for the first quarter of 2020 was ($6.7) million, or ($0.18) per fully diluted common share, compared to a net loss of ($297,000), or ($0.01) per fully diluted common share for the first quarter of 2019. Non-GAAP net loss for the first quarter of 2020 was ($3.0) million, or ($0.08) per fully diluted common share, compared to non-GAAP net income of $1.5 million, or $0.04 per fully diluted common share for the first quarter of 2019. Net loss on both a GAAP and non-GAAP basis reflects a $3.7 million pretax loss primarily related to non-cash unrealized foreign currency losses on intercompany payable balances.

2020 Financial Outlook
As previously reported on April 1, 2020, the Company has withdrawn its 2020 financial guidance due to uncertainties resulting from the COVID-19 pandemic.

All numbers are presented on a GAAP basis except where expressly referenced as non-GAAP. The Company does not provide GAAP income per common share on a forward-looking basis because the Company is unable to predict with reasonable certainty business development and acquisition-related expenses, purchase accounting fair value adjustments, and any unusual gains and losses without unreasonable effort. These items are uncertain, depend on various factors, and could be material to results computed in accordance with GAAP.

The Company’s financial performance for 2020 is subject to the risks identified below.

Non-GAAP Financial Measures
This press release contains non-GAAP financial measures. Investors should consider this non-GAAP information in addition to, and not as a substitute for, financial measures prepared in accordance with U.S. GAAP. In addition, this non-GAAP financial information may not be the same as similar measures presented by other companies. The Company’s non-GAAP net income and non-GAAP EBITDA results exclude (as applicable) business development and integration expenses, amortization expense, inventory basis step-up expense, loss on foreign currency revaluation, stock-based compensation expense, and corporate rebranding expenses. The Company believes that these non-GAAP presentations provide useful information to investors regarding unusual non-operating transactions; the operating expense structure of the Company’s existing and recently acquired operations, without regard to its on-going efforts to acquire additional complementary products and businesses and the transaction and integration expenses incurred in connection with recently acquired and divested product lines; and the operating expense structure excluding fluctuations resulting from foreign currency revaluation and stock-based compensation expense. The Company believes it is useful to exclude certain expenses because such amounts in any specific period may not directly correlate to the underlying performance of its business operations or can vary significantly between periods as a result of factors such as acquisitions, or non-cash expense related to amortization of previously acquired tangible and intangible assets. The Company has excluded the impact of changes in currency exchange from certain revenues to evaluate growth rates on a constant currency basis. The Company does, however, expect to incur similar types of expenses and currency exchange impacts in the future, and this non-GAAP financial information should not be viewed as a statement or indication that these types of expenses will not recur.

Webcast and Conference Call Information
The Company will hold a teleconference call and live webcast later today, April 30, 2020 at 4:30 p.m. ET to discuss the results followed by a question and answer session. To listen to the live teleconference, please dial 201-689-8261. A replay of the teleconference will be available through May 7, 2020 and can be accessed by calling (toll free) 877-660-6853 or 201-612-7415. The Conference ID for the replay is 13702193.

The live webcast and replay can be accessed by going to the Investor Relations section of the CryoLife website at www.cryolife.com and selecting the heading Webcasts & Presentations.

On April 30, 2020 Viking Therapeutics, Inc. (Viking) (NASDAQ: VKTX), a clinical-stage biopharmaceutical company focused on the development of novel therapies for metabolic and endocrine disorders, reported its financial results for the first quarter ended March 31, 2020, and provided an update on its clinical pipeline and other corporate developments (Press release, Viking Global Investors, APR 30, 2020, View Source [SID1234556873]).

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Highlights from the Quarter Ended March 31, 2020:

"During the first quarter, we made continued progress on our Phase 2b VOYAGE clinical trial evaluating VK2809 in patients with biopsy-confirmed NASH and fibrosis," stated Brian Lian, Ph.D., chief executive officer of Viking Therapeutics. "We have been proactive in implementing steps to mitigate the potential impact of the coronavirus pandemic, and are closely monitoring this evolving challenge. We are encouraged that enrolled patients continue to receive treatment, new patients continue to enroll, and clinical site activations remain ongoing. That said, the pandemic has disrupted each of these activities on some level. We currently anticipate completion of enrollment in VOYAGE in the first half of 2021. In the first quarter, we also made progress with our second thyroid hormone receptor beta agonist, VK0214, for the treatment of X-linked adrenoleukodystrophy. We currently expect to submit an IND for VK0214 this summer and initiate clinical studies with this candidate in the third quarter. Finally, we remain vigilant in managing our balance sheet and ended the quarter with $269 million in cash and cash equivalents, which we believe provides sufficient runway to accomplish multiple development milestones."

Pipeline and Corporate Highlights

Enrollment continues in Phase 2b VOYAGE study evaluating VK2809 in biopsy-confirmed non-alcoholic steatohepatitis (NASH) and fibrosis. VK2809 is an orally available small molecule agonist of the thyroid hormone receptor that possesses selectivity for liver tissue, as well as the beta receptor subtype, and has demonstrated promising therapeutic potential in a range of lipid disorders, including NASH. In September 2018, the company announced positive results from a 12-week Phase 2 trial of VK2809 in patients with hypercholesterolemia and non-alcoholic fatty liver disease (NAFLD). Patients receiving VK2809 in this study demonstrated potent reductions in liver fat content and plasma lipids compared with patients receiving placebo.

In 2019, the company initiated the Phase 2b VOYAGE trial. This trial is a randomized, double-blind, placebo-controlled, multicenter study designed to assess the efficacy, safety and tolerability of VK2809 in patients with biopsy-confirmed NASH and fibrosis ranging from stages F1 to F3. The study is targeting enrollment of approximately 340 patients across five treatment arms: 1.0 mg daily; 2.5 mg daily; 5.0 mg every other day; 10.0 mg every other day; and placebo.

The primary endpoint of the study will evaluate the relative change in liver fat content, as assessed by magnetic resonance imaging, proton density fat fraction (MRI-PDFF) from baseline to Week 12 in subjects treated with VK2809, as compared to placebo. Secondary objectives include evaluation of histologic changes assessed by hepatic biopsy after 52 weeks of dosing. Enrollment is continuing at U.S. sites, with ex-U.S. sites expected to open later this year.

Additional data from VK2809 Phase 2 trial to be highlighted in podium presentation at EASL. An abstract describing additional data from the company’s completed 12-week Phase 2 trial of VK2809 in patients with NAFLD and hypercholesterolemia has been selected for oral presentation at the 2020 International Liver Congress, hosted by the European Association for the Study of the Liver (EASL). Due to the COVID-19 pandemic, this event has been postponed until August 25-28, 2020.

IND-enabling work near completion for VK0214 for the treatment of X-ALD – IND filing expected mid-year. VK0214 is being evaluated as a potential treatment for X-linked adrenoleukodystrophy (X-ALD), a devastating disease for which there is currently no therapeutic treatment. X-ALD is caused by a defect in the ABCD1 peroxisomal transporter. This defect can result in an accumulation of very long chain fatty acids in plasma and tissue, which is believed to contribute to the severe cerebral and motor neuron toxicities that are characteristic of the disease.

To date, findings from in vitro and in vivo studies have demonstrated that administration of VK0214 results in a significant reduction of very long chain fatty acids in both plasma and tissue, potentially leading to a therapeutic benefit. These promising results were achieved through the company’s ongoing collaboration with the Kennedy Krieger Institute – one of the world’s leading X-ALD research centers. The company plans to file an IND in mid-2020 and initiate clinical studies in the third quarter.

Balance sheet remains strong with approximately $270 million in cash. Viking completed the first quarter of 2020 with $269.2 million in cash, cash equivalents and short-term investments.

Upcoming investor events. Viking management will participate in the following upcoming investor events:
6th Annual SunTrust Robinson Humphrey Life Science Summit
Date: May 5- 6, 2020
Virtual Format

UBS Global Healthcare Conference
Dates: May 18 – 20, 2020
Virtual Format

Jefferies Global Healthcare Conference
Dates: June 2 –4, 2020
Virtual Format

Raymond James Healthcare Conference
Dates: June 16 – 17, 2020
Virtual Format

Q1 2020 Financial Highlights

Research and development expenses for the three months ended March 31, 2020 were $8.0 million compared to $4.5 million for the same period in 2019. The increase was primarily due to increased expenses related to our clinical studies, with the initiation of the Phase 2b VOYAGE study in November 2019, pre-clinical studies, and manufacturing for our drug candidates, partially offset by decreased expenses related to services provided by third-party consultants.

General and administrative expenses for the three months ended March 31, 2020 were $3.0 million compared to $2.3 million for the same period in 2019. The increase was primarily due to increased expenses related to stock-based compensation, legal expenses, and salaries and benefits, partially offset by decreased expenses related to services provided by third-party consultants and professional fees.

For the three months ended March 31, 2020, Viking reported a net loss of $9.7 million, or $0.13 per share, compared to a net loss of $4.9 million, or $0.07 per share, in the corresponding period in 2019. The increase in net loss and net loss per share for the three months ended March 31, 2020 was primarily due to increased research and development and general and administrative expenses noted previously, as well as decreased interest income due to the decline in interest rates throughout the first quarter of 2020 as compared to prevailing interest rates during the first quarter of 2019.

Balance Sheet as of March 31, 2020

At March 31, 2020, Viking held cash, cash equivalents and short-term investments totaling $269.2 million and had 72,562,863 shares of common stock outstanding.

Conference Call

Management will host a conference call to discuss the company’s first quarter 2020 financial results today at 4:30 pm Eastern. To participate in the conference call, please dial (844) 850-0543 from the U.S. or (412) 317-5199 from outside the U.S. In addition, following the completion of the call, a telephone replay will be accessible until May 7, 2020 by dialing (877) 344-7529 from the U.S. or (412) 317-0088 from outside the U.S. and entering conference ID # 10141875. Those interested in listening to the conference call live via the internet may do so by visiting the Investor Relations section of Viking’s website at www.vikingtherapeutics.com. An archive of the webcast will be available for 30 days on the company’s website at www.vikingtherapeutics.com.