On August 6, 2020 Intellia Therapeutics, Inc. (NASDAQ:NTLA), a leading genome editing company focused on developing curative therapeutics using CRISPR/Cas9 technology both in vivo and ex vivo, reported operational highlights and financial results for the second quarter ended June 30, 2020 (Press release, Intellia Therapeutics, AUG 6, 2020, View Source [SID1234563133]).

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"We are very pleased to announce our first regulatory submission to initiate a Phase 1 study of NTLA-2001, which is an important milestone as we deliver on our mission to develop curative, CRISPR/Cas9-based treatments for severe diseases. Our CTA keeps us on track to dose our first ATTR patient by year-end and is a critical step in executing our global development strategy for the first systemically delivered CRISPR-based therapy to enter clinical trial," said Intellia President and Chief Executive Officer, John Leonard, M.D. "With our recently expanded collaboration with Regeneron and subsequent financing, we are well-capitalized to advance our initial wave of development programs and continue our work developing innovative modular platform capabilities."

Second Quarter 2020 and Recent Operational Highlights

ATTR Program: Intellia announced today it has submitted its first Clinical Trial Application (CTA) to the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) to initiate a Phase 1 study of NTLA-2001 for the treatment of transthyretin amyloidosis (ATTR). Based on the Company’s in vivo liver knockout approach, NTLA-2001 is a potential single-course therapy for patients living with ATTR. Pending CTA authorization and subject to the impact of COVID-19, the Company is on track to dose its first patient by the end of 2020 with the first systemically delivered CRISPR/Cas9-based therapy to enter the clinic. The Company is submitting additional regulatory applications to enable enrollment in other countries as part of its global development strategy. NTLA-2001 is part of a co-development/co-promotion agreement between Intellia, the lead development and commercialization party, and Regeneron Pharmaceuticals, Inc. (Regeneron).
AML Program: NTLA-5001 is a wholly owned, T cell receptor (TCR)-T cell therapy development candidate targeting the Wilms’ Tumor 1 (WT1) antigen for the treatment of acute myeloid leukemia (AML). The Company’s approach aims to develop a broadly applicable treatment for AML patients, regardless of the mutational subtypes of the cancer. At the American Society of Gene and Cell Therapy (ASGCT) (Free ASGCT Whitepaper) Annual Meeting, held from May 12-15, 2020, Intellia presented data on its proprietary T cell engineering process in support of NTLA-5001. The data showed that the Company’s proprietary process enables multiple, highly efficient, sequential edits in T cells, whether knocking out or inserting genes. This technology yields engineered cells with high anti-tumor activity and favorable attributes, including a desired memory phenotype, which is associated with longer-lasting treatment effects. Importantly, chromosomal translocations (i.e., undesired chromosomal rearrangements) were similar to background levels in untreated cells. Intellia continues to advance Investigational New Drug application (IND)-enabling activities and remains on track to submit an IND or IND-equivalent for NTLA-5001 in the first half of 2021. Additional efforts are underway to evaluate potential use of the WT1-targeted TCR construct to treat solid tumors.
HAE Program: NTLA-2002 is a wholly owned, in vivo development candidate for the treatment of hereditary angioedema (HAE). Building on Intellia’s modular lipid nanoparticle (LNP) delivery system, NTLA-2002 is designed to knock out the prekallikrein B1 (KLKB1) gene in the liver after a single course of treatment, which is expected to prevent improperly regulated bradykinin production and therefore, reduce HAE attacks. In a non-human primate (NHP) study of its lead LNP formulation for NTLA-2002, the knockout of KLKB1 resulted in a therapeutically relevant reduction of serum kallikrein levels and activity following a single dose. Consistent with the durability achieved in earlier NHP studies for its lead in vivo program, the Company has now demonstrated sustained kallikrein activity reduction for 10 months in an ongoing study. Based on these results, Intellia believes NTLA-2002 could be efficacious and durable in preventing HAE attacks following a single course of treatment. Intellia continues to progress IND-enabling activities and is on track to submit an IND or IND-equivalent for NTLA-2002 in the second half of 2021.
Modular Platform: Intellia continues to make significant progress across its platform technologies, broadening the in vivo and ex vivo application of genome editing. This includes developing innovative CRISPR/Cas9-mediated targeted transgene insertion and allogeneic cell solutions. Additionally, to supplement its ex vivo capabilities, the Company established research collaborations and license agreements with TeneoBio and GEMoaB GmbH to develop engineered cell therapies for immuno-oncology and autoimmune diseases. Intellia’s broad platform innovations and expanded capabilities will drive the next wave of in vivo and ex vivo clinical candidates.
Regeneron Collaboration: In June 2020, Intellia and Regeneron announced an expansion of their existing collaboration to co-develop potential products for the treatment of hemophilia A and B. The collaboration expansion builds upon the jointly-developed targeted transgene insertion capabilities designed to durably restore a missing protein and to overcome the limitations of traditional gene therapy. The collaboration also provides Regeneron with rights to develop products for additional in vivo CRISPR/Cas9-based therapeutic liver targets. Under the expansion, the term of the collaboration has been extended until April 2024, at which point Regeneron has an option to renew for an additional two years. In addition, the expansion grants Regeneron a royalty-bearing, non-exclusive license to certain Intellia intellectual property to develop and commercialize up to 10 ex vivo CRISPR/Cas9 products in defined cell types. Intellia received $100 million through an upfront payment of $70 million and an additional $30 million equity investment from Regeneron at $32.42 per share.
Financing: In June 2020, Intellia closed an underwritten public offering of 6,301,370 shares of common stock, including the exercise in full of the underwriters’ option to purchase additional shares, at the public offering price of $18.25 per share. Intellia received aggregate gross proceeds of approximately $115 million, before underwriting discounts and commissions and offering expenses.
Upcoming Events

The Company will participate in the following events during the third quarter of 2020:

Wedbush PacGrow Healthcare Conference, August 11, Virtual
Baird Healthcare Conference, September 9, Virtual
Upcoming Milestones

The Company has set forth the following for pipeline progression:

ATTR: Plan to dose first patient by end of 2020
AML: Submit an IND or IND-equivalent for NTLA-5001 in 1H 2021
HAE: Submit an IND or IND-equivalent for NTLA-2002 in 2H 2021
Second Quarter 2020 Financial Results

Cash Position: Cash, cash equivalents and marketable securities were $436.8 million as of June 30, 2020, compared to $284.5 million as of December 31, 2019. The increase was driven by net proceeds of $107.7 million from the June follow-on public offering, $100.0 million upfront payment from the Regeneron collaboration expansion, which included a $30.0 million equity investment, $14.7 million of net equity proceeds raised from the Company’s "At the Market" (ATM) agreement, $14.4 million of funding received under existing collaborations with Regeneron and Novartis and $2.1 million in proceeds from employee-based stock plans. These increases were offset in part by cash used to fund operations of approximately $86.5 million.
Collaboration Revenue: Collaboration revenue increased by $5.1 million to $16.3 million during the second quarter of 2020, compared to $11.1 million during the second quarter of 2019. The increase in collaboration revenue in 2020 was mainly driven by an $8.4 million one-time cumulative catch-up adjustment related to the extension of the Regeneron collaboration.
R&D Expenses: Research and development expenses increased by $12.3 million to $37.8 million during the second quarter of 2020, compared to $25.5 million during the second quarter of 2019. This increase was primarily driven by IND-enabling activities related to our lead programs, research personnel growth to support these programs, and the expansion of the development organization.
G&A Expenses: General and administrative expenses decreased by $1.6 million to $11.5 million during the second quarter of 2020, compared to $13.1 million during the second quarter of 2019. This decrease was primarily driven by a decrease in legal expenses, which were principally related to a decrease in certain activities related to intellectual property matters.
Net Loss: The Company’s net loss was $32.4 million for the second quarter of 2020, compared to $25.7 million during the second quarter of 2019.
Financial Guidance

Intellia expects that its cash, cash equivalents and marketable securities as of June 30, 2020 will enable the Company to fund its anticipated operating expenses and capital expenditure requirements at least through the next 24 months. This expectation excludes any strategic use of capital not currently in the Company’s base-case planning assumptions.

Conference Call to Discuss Second Quarter 2020 Earnings

The Company will discuss these results on a conference call today, August 6, 2020, at 8 a.m. ET.

To join the call:

U.S. callers should dial 1-877-317-6789 and international callers should dial +1-412-317-6789, approximately five minutes before the call.
All participants should ask to be connected to the Intellia Therapeutics conference call.
A replay of the call will be available through the Events and Presentations page of the Investors & Media section on Intellia’s website at www.intelliatx.com, beginning on August 6, 2020 at 12 p.m. ET.

On August 6, 2020 Selecta Biosciences, Inc. (NASDAQ: SELB), a clinical-stage biotechnology company focused on unlocking the full potential of biologic therapies based on its immune tolerance platform, ImmTOR, reported financial results for the second quarter ended June 30, 2020 and provided corporate updates (Press release, Selecta Biosciences, AUG 6, 2020, View Source [SID1234563132]).

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"This is a transformational time for Selecta, as we reinforce our position as a leader in immune tolerance. The strategic licensing agreement with Sobi puts us in a financial position that allows us to maximize efforts to unlock the full potential of the ImmTOR immune tolerance platform, by optimizing the efficacy and safety of biologics, enabling re-dosing of life saving gene therapies, and creating novel immunotherapies for autoimmune diseases," said Carsten Brunn, Ph.D., President and CEO of Selecta. "We remain committed to the development of SEL-212, and look forward to the initiation of the Phase 3 clinical program with Sobi in the third quarter of this year and the topline data readout from the Phase 2 COMPARE trial, also in the third quarter. We also look forward to advancing our gene therapy program in MMA to the clinic in the first half of 2021, and for the submission of an IND for our autoimmune diseases program, also in 2021."

Recent Highlights and Anticipated Upcoming Milestones:

Closed Strategic Licensing Agreement with Sobi for SEL-212, the Company’s Phase 3-ready Novel Treatment for Chronic Refractory Gout: The Company announced the closing of a strategic licensing agreement with Sobi for SEL-212, the Company’s lead product candidate leveraging the ImmTOR immune tolerance platform. Sobi assumes responsibility for all development, regulatory, and commercial activities, and expenses in all markets outside China, while Selecta will run the Phase 3 study on behalf of Sobi, at Sobi’s expense. Selecta will also maintain manufacturing of ImmTOR, for which Sobi will reimburse Selecta for activities relating to SEL-212. The initial payments to Selecta total $100 million. Sobi must pay $75 million in cash as an upfront license fee within 45 days of the effective date and has paid $25 million in cash in a private placement of Selecta common stock at $4.62 per share. Selecta is also eligible to receive potential development, regulatory, and commercial milestone payments of up to $630 million, and tiered double-digit royalties on net sales.

Entered into Research License and Option Agreement with Sarepta for the Use of ImmTOR in Certain Neuromuscular Diseases: Selecta and Sarepta reached an agreement which provides Sarepta with the option to license the rights to develop and commercialize the ImmTOR platform for use in select neuromuscular diseases; Duchenne muscular dystrophy (DMD) and certain limb-girdle muscular dystrophies (LGMDs). Sarepta will evaluate its investigational gene therapies in combination with ImmTOR to mitigate the formation of neutralizing antibodies. Sarepta has made an initial payment to Selecta, and Selecta is eligible to receive certain pre-clinical milestone fees.

Two Key Clinical Milestones for SEL-212: Selecta and Sobi anticipate initiating the Phase 3 clinical program in the third quarter of 2020. Selecta will take the lead running the Phase 3 program, at Sobi’s expense. The Phase 3 clinical program will consist of two double blinded, placebo-controlled trials of SEL-212. Each trial is expected to enroll 105 patients and have 35 patients receiving 0.1 mg/kg of ImmTOR and 0.2 mg/kg of pegadricase, 35 patients receiving 0.15 mg/kg of ImmTOR and 0.2 mg/kg of pegadricase, and 35 patients receiving placebo. The primary endpoint of the Phase 3 clinical trials is the maintenance of serum uric acid (SUA) levels of <6mg/dL at six months. One of the trials will have a six-month extension. In addition, the Company expects topline results from the Phase 2 COMPARE clinical trial in Q3 2020. This head-to-head study of a once-monthly dose of SEL-212 (ImmTOR + pegadricase) compared to biweekly doses of pegloticase is expected to read out on schedule. The primary endpoint of the COMPARE trial is the maintenance of serum uric acid (SUA) levels of <6mg/dL at three and six months.

Timeline for Gene Therapy and Autoimmune Diseases Programs Confirmed: The Company’s gene therapy program in methylmalonic acidemia, or MMA, in collaboration with AskBio, is expected to enter the clinic in the first half of 2021, with preliminary data expected in 2H 2021. In addition, Selecta intends to submit its Investigational New Drug Application (IND) for its autoimmune disease program in 2021. The first indication will be IgA nephropathy, a kidney disease that occurs when an antibody called immunoglobulin A (IgA) accumulates in the kidneys. The second indication is expected to be primary biliary cholangitis, or PBC, an autoimmune disease that causes progressive destruction of the bile ducts. Both diseases have well-defined target antigens, significant unmet medical need, and are well suited to the application of Selecta’s ImmTOR immune tolerance platform.

Appointed Peter G. Traber, MD, to the Position of Chief Medical Officer: Dr. Traber, who has been serving in the same position in an interim capacity, joined the Company full-time as of August 1, 2020. Dr. Traber has a broad range of experience in large pharma, biotech, and academia, and will oversee medical affairs, program management, and all aspects of clinical development and strategy, as well as provide scientific and clinical guidance for potential business development initiatives.
Second Quarter 2020 Financial Results:

Cash Position: Selecta had $61.4 million in cash, cash equivalents, and restricted cash as of June 30, 2020, which compares to cash, cash equivalents, and restricted cash of $91.6 million as of December 31, 2019. Selecta believes its available cash, cash equivalents, and restricted cash as of June 30, 2020, together with the $25 million payment received from Sobi under the Sobi Private Placement in July and the expected payment from Sobi of $75 million under the Sobi License, which is due 45 days after the effective date, will enable Selecta to fund operating expenses and capital expenditure requirements into the first quarter of 2023.

Net cash used in operating activities was $23.5 million for the six months ended June 30, 2020, as compared to $27.4 million for the same period in 2019.

Research and Development Expenses: Research and development expenses for the second quarter 2020 were $10.7 million, which compares with $12.1 million for the same period in 2019. The decrease in costs was primarily the result of reduced expense for the Phase 2 COMPARE trial for SEL-212 offset by increases for the gene therapy program in collaboration with AskBio, and salaries and benefits.

General and Administrative Expenses: General and administrative expenses for the second quarter 2020 were $5.6 million, which compares with $4.1 million for the same period in 2019. The increase in costs was the result of expenses incurred for salaries, legal and professional fees offset by decreased travel expense.

Net Loss: For the second quarter 2020, Selecta reported a net loss of $24.1 million, or $0.25 per share, compared to a net loss of $16.4 million, or $0.37 per share, for the same period in 2019.
Conference Call and Webcast Reminder:
Selecta management will host a conference call at 8:30 a.m. ET today to provide a corporate update and review the company’s second quarter 2020 financial results. Individuals may participate in the live call via telephone by dialing (844) 845-4170 (domestic) or (412) 717-9621 (international) and may access a teleconference replay for one week by dialing (877) 344-7529 (domestic) or (412) 317-0088 (international) and using confirmation code 10138605. Investors and the public can access the live and archived webcast of this call via the Investors & Media section of the company’s website, www.selectabio.com.

On August 6, 2020 Agenus Inc. (NASDAQ: AGEN), an immuno-oncology company with an extensive pipeline of checkpoint antibodies, cell therapy, adjuvants, and vaccines designed to activate immune response to cancers and infections, reported financial results for the second quarter of 2020 (Press release, Agenus, AUG 6, 2020, View Source [SID1234563131]).

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Balstilimab BLA filing to be initiated in current quarter
Balstilimab granted FTD and eligible for priority review
Combo trial with zali completes accrual & required follow-up; BLA planning underway
Zalifrelimab actives responses in PD-1 refractory tumors (1CR, 3PRs)
Ph2 expansion trial in angiosarcoma underway; additional cancers to follow
AGEN1181 combo w bali achieves CR with both primary and metastatic tumors confirmed by PET scan
Updated Ph1 achieves a total of 2 CRs & clinical benefit (CR/PR/SD) in ~65% patients
Expansion cohorts in NSCLC, MSS tumors, melanoma, and RCC launched
AGEN2373 achieves durable SD in ovarian, lung, sarcoma
No liver toxicity observed
AGEN2373 advancing to combo with balstilimab
Production of QS-21 from a renewable source achieved and equivalence to QS-21 Saponin demonstrated
High-yield process development underway
Bioequivalence to first-generation demonstrated
Enhanced antibody responses achieved in SARS-CoV-2 models
Completed partnership with Betta Pharmaceuticals; $15M upfront, $20M equity investment, $100M in milestones & royalties
Rights to balstilimab and zalifrelimab for Greater China
Clinical development in major cancers being planned
First Quarter Financial Results
We ended the second quarter of 2020 with a cash balance of $79 million as compared to $62 million at December 31, 2019. Subsequent to the quarter end we received $35 million related to our Betta partnership. With this and other anticipated cash inflows, based on our current plans and projections our cash position will be sufficient to support our operations into the third quarter of 2021.

For the second quarter ended June 30, 2020, our cash used in operations was $37 million and we reported a net loss of $48 million or $0.28 per share. This compares to cash used in operations for the same period in 2019 of $36 million and a net loss of $52 million or $0.38 per share.

Our cash used in operations for the six months ended June 30, 2020 was $72 million with a net loss of $94 million or $0.59 per share compared to cash provided by operations of $41 million and a net loss for the same period in 2019 of $34 million or $0.24 per share.

For the six-month period ended June 30, 2020, we recognized revenue of $42 million which includes revenue related to the upfront license fee from our transaction with Betta in addition to non-cash royalties earned. For the same period in 2019 we recorded revenue of $96 million which includes revenue related to the upfront license fee from our transaction with Gilead in addition to non-cash royalties earned.

Call Access

To access the live call, dial 1-844-492-3727 (U.S.) or 1-412-317-5118 (International) and ask to be joined into the Agenus call. The call will also be webcast and will be accessible from the Company’s website at View Source or via View Source A replay will be available approximately two hours after the call and will remain available until November 7, 2020.

On August 6, 2020 TG Therapeutics, Inc. (NASDAQ: TGTX), reported that a conference call will be held on Monday August 10, 2020 at 8:30 AM ET to discuss results for the second quarter of 2020 and provide a business outlook for the remainder of the year (Press release, TG Therapeutics, AUG 6, 2020, https://ir.tgtherapeutics.com/news-releases/news-release-details/tg-therapeutics-host-conference-call-second-quarter-2020 [SID1234563130]). Michael S. Weiss, Executive Chairman and Chief Executive Officer, will host the call.

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In order to participate in the conference call, please call 1-877-407-8029 (U.S.), 1-201-689-8029 (outside the U.S.), Conference Title: TG Therapeutics Second Quarter 2020 Business Update Call. A live webcast of this presentation will be available on the Events page, located within the Investors & Media section, of the Company’s website at www.tgtherapeutics.com. An audio recording of the conference call will also be available for replay at www.tgtherapeutics.com, for a period of 30 days after the call.

TG Therapeutics will announce its financial results for this period in a press release to be issued prior to the call.

On August 6, 2020 BioCryst Pharmaceuticals, Inc. (Nasdaq:BCRX) reported financial results for the second quarter ended June 30, 2020, and provided a corporate update (Press release, BioCryst Pharmaceuticals, AUG 6, 2020, View Source [SID1234563129]).

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"BioCryst is currently in an exciting transformation from a company primarily focused on R&D to one that is about to launch its first oral drug to patients with HAE (ORLADEYO) this year, generating meaningful revenue starting next year, with global peak sales potential of greater than half a billion dollars. In parallel, we plan to fill our pipeline with a single molecule, BCX9930, by investing to accelerate this program across multiple rare disease indications based on the proof of concept data we have," said Jon Stonehouse, president and chief executive officer of BioCryst.

"We expect to end the year with ORLADEYO approved in the U.S. and Japan, additional data at 200 mg and 400 mg with BCX9930 in PNH patients, and clinical data from galidesivir in COVID-19 patients," Stonehouse added.

Program Updates and Key Milestones

Hereditary Angioedema (HAE) Program – ORLADEYO: Oral, once-daily treatment for prevention of HAE attacks
BioCryst expects three regulatory approvals for ORLADEYO in Q4 2020 and early 2021.

The U.S. Food and Drug Administration (FDA) is reviewing a new drug application for ORLADEYO and has set an action date of December 3, 2020, under the Prescription Drug User Fee Act (PDUFA).

In Japan, ORLADEYO is being reviewed under Sakigake designation. The Pharmaceutical and Medical Devices Agency (PMDA) has confirmed their regulatory review schedule and the company expects an approval decision in December 2020.

On March 30, 2020, the company announced that the European Medicines Agency (EMA) had validated its marketing authorization application (MAA) submission for ORLADEYO and begun its formal review of the MAA under the centralized procedure. The company expects an opinion from the Committee for Medicinal Products for Human Use (CHMP) within approximately 12 months from MAA validation.

BioCryst has completed significant preparations to support the launch of ORLADEYO in the U.S.

The company has attracted an accomplished U.S. rare disease sales team, which averages 20 years in pharmaceutical sales and nearly a decade of rare disease experience.

The company is well-positioned in terms of product supply and inventory on-hand to support the launch and anticipated global demand for ORLADEYO.

On June 9, 2020, the company announced that it had established an expanded access program with ORLADEYO for patients with HAE in the United States. Through this program, physicians may be able to request ORLADEYO for HAE patients who do not have access to the product through a clinical trial.

On June 6, at the European Academy of Allergy and Clinical Immunology (EAACI) Digital Congress, the company presented new data highlighting the burden of therapy faced by HAE patients taking currently available injectable prophylactic medication. Patients taking oral, once daily ORLADEYO experienced sustained decreases in their attack frequency and improvements in quality of life scores over 48 weeks. ORLADEYO was also safe and generally well-tolerated over 48 weeks in both the APeX-2 and APeX-S clinical trials.
"Our ongoing dialogue and research with HAE patients and physicians continue to reinforce their strong demand for an oral, once-daily medicine that is safe and provides the significant and sustained attack reduction we are seeing with ORLADEYO in our clinical program. Nearly half of patients in our APeX-2 and APeX-S trials have prior experience with injectable or infused therapies and most have chosen to remain on ORLADEYO," said Charlie Gayer, chief commercial officer of BioCryst.

Complement Oral Factor D Inhibitor Program – BCX9930

On August 3, 2020, the company announced that the FDA has granted Fast Track designation for BCX9930 for the treatment of paroxysmal nocturnal hemoglobinuria (PNH). According to the FDA, the purpose of the Fast Track designation is to get important new drugs to the patient earlier by facilitating the development, and expediting the review of, drugs to treat serious conditions and fill an unmet medical need.

On May 6, 2020, the company reported proof of concept data for BCX9930 in three treatment-naïve PNH patients in the lowest dose cohort of 50 mg (14 days) and 100 mg (14 days) twice-daily. BCX9930 inhibited complement and was safe and generally well tolerated.

Based on the investigators’ assessment, three patients receiving 50 mg and 100 mg twice daily experienced clinical benefit, continued on therapy and are now receiving BCX9930 therapy at higher doses. An additional treatment-naïve PNH cohort, which starts at 200 mg (14 days) followed by 400 mg (14 days) twice-daily, has also begun enrollment. The company expects to report data from treatment-naïve PNH patients receiving 200 mg / 400 mg twice daily in Q3 2020.

The company plans to report data from PNH patients who are poor responders to C5 inhibitors receiving 200 mg / 400 mg twice daily by the end of 2020.

Based on the safety and proof-of-concept data generated to date in PNH patients, the company is working closely with key opinion leaders in hematology and nephrology to map the development strategy across a broad set of indications.
"We plan to meet with regulators later this year to confirm our advanced development plan for BCX9930 in PNH. Because the alternative pathway of complement is also directly related to several complement-mediated diseases, we plan to broaden and accelerate the BCX9930 program to patients in multiple disease areas as quickly as possible," said Dr. William Sheridan, chief medical officer of BioCryst.

Coronavirus Antiviral Program – Galidesivir (BCX4430)

In response to the COVID-19 pandemic, the company is conducting a randomized, double-blind, placebo-controlled clinical trial (NCT03891420) in Brazil to assess the safety, clinical impact and antiviral effects of galidesivir in COVID-19 patients. The company expects to provide information from Part 1 of this ongoing clinical trial by the end of Q3 2020.

The galidesivir program is being substantially funded by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, and the Biomedical Advanced Research and Development Authority (BARDA). The goal of the galidesivir clinical program is to evaluate clinical activity that would support additional government investment and advanced development of galidesivir, including additional drug supply.
Additional Updates

The company remains on track to report data in 2H 2020 from its ongoing Phase 1 clinical trial of BCX9250, an oral ALK-2 kinase inhibitor for treatment of fibrodysplasia ossificans progressiva (FOP), in healthy subjects.
Second Quarter 2020 Financial Results

For the three months ended June 30, 2020, total revenues were $2.9 million, compared to $1.4 million in the second quarter of 2019. The increase was primarily due to an increase in collaboration revenue under U.S. government development contracts.

Research and development (R&D) expenses for the second quarter of 2020 were $27.5 million, similar to $27.7 million in the second quarter of 2019. During the second quarter of 2020, R&D spending increased on the company’s complement-mediated diseases and galidesivir programs, which was offset by a reduction in spend on the ORLADEYO program as the company approaches commercial launch.

Selling, general and administrative (SG&A) expenses for the second quarter of 2020 increased to $13.9 million, compared to SG&A expenses of $8.7 million in the second quarter of 2019. The increase was primarily due to increased spending on commercial activities and medical affairs to support the U.S. commercial launch of ORLADEYO in 2020.

Interest and other income were $2.8 million in the second quarter of 2020, compared to $0.5 million in the second quarter of 2019. The increase was primarily due to recognition of income from our arbitration proceedings.

Interest expense was $2.9 million in the second quarter of 2020, compared to $3.0 million in the second quarter of 2019.

Net loss for the second quarter of 2020 was $38.6 million, or $0.24 per share, compared to a net loss of $37.6 million, or $0.34 per share, for the second quarter of 2019.

Cash, cash equivalents and investments and restricted cash totaled $191.6 million at June 30, 2020, and reflect an increase from $137.8 million at December 31, 2019 and $114.6 million at March 31, 2020. Operating cash use for the second quarter of 2020 was $31.8 million.

Financial Outlook for 2020

With the additional capital raised in Q2 and the safety and proof-of concept data generated to-date with BCX9930 in PNH patients, the company is investing in accelerated development of BCX9930 and expects full year 2020 net operating cash use to be in the range of $150 to $165 million, and its operating expenses to be in the range of $180 to $195 million. The company’s operating expense range excludes equity-based compensation expense due to the difficulty in reliably projecting this expense, as it is impacted by the volatility and price of the company’s stock, as well as by the vesting of the company’s outstanding performance-based stock options.

Conference Call and Webcast

BioCryst management will host a conference call and webcast at 8:30 a.m. ET today to discuss the financial results and provide a corporate update. The live call may be accessed by dialing 877-303-8027 for domestic callers and 760-536-5165 for international callers and using conference ID # 5142479. A live webcast of the call and any slides will be available online at the investors section of the company website at www.biocryst.com. A telephone replay of the call will be available by dialing 855-859-2056 for domestic callers or 404-537-3406 for international callers and entering the conference ID # 5142479.