On August 7, 2020 Orgenesis Inc. (NASDAQ: ORGS) ("Orgenesis" or the "Company"), a pioneering, global biotech company committed to accelerating commercialization and transforming the delivery of cell and gene therapies (CGTs), reported a business update for the second quarter ended June 30, 2020 (Press release, Orgenesis, AUG 7, 2020, View Source [SID1234563158]).

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Vered Caplan, CEO of Orgenesis, stated, "We continue to implement our Point of Care (POCare) cell and gene therapy strategy, including the expansion of our network, as evidenced by the expected revenue growth. Revenue for the second quarter of 2020 increased 55% to $1.7 million compared to $1.1 million for the second quarter of 2019. We have also maintained a solid balance sheet with over $97.5 million of cash and cash equivalents as of June 30, 2020. Our true progress can be seen in the advancement of our POCare Therapeutics pipeline, including immuno-oncology, metabolic, and anti-viral therapies. Our mission is to make these therapies available to large numbers of patients at reduced costs using the point-of-care model. Our POCare Network also continues to grow via new partnerships with leading hospitals and research institutes around the world."

"We have made progress towards our goal of adapting our cell-based and antiviral technologies to address the COVID-19 pandemic. First, we are focused on advancing our cell-based vaccine platform in order to target COVID-19, as well as other potential existing and emerging viral diseases. Second, we recently launched our BioShield Program, which is designed to potentially accelerate discovery and set up a first line of defense against the spread of viral pathogens, such as COVID-19. And finally, we are engaging with industry partners for the development of Ranpirnase for the potential treatment of COVID-19, as well as other viruses."

The Company remained active through the second quarter and into the third quarter of 2020, reporting the following recent advances:

Entered into a Collaboration Agreement with Educell Ltd., a premier European cell therapy company, to conduct clinical validation of the POCare Technologies for the expansion of T-cells in a whole cell-based vaccine platform for use in cancer immunotherapies.
Entered into a Clinical Study Agreement with The Edith Wolfson Medical Center, a leading public hospital in Israel, to conduct a joint clinical study to validate the partnered POCare Technologies.
Advanced development of a novel cell-based vaccine platform targeting COVID-19 and other existing and emerging viral diseases; plans to commence animal testing trials with human testing expected to follow pending clearance from the FDA and/or other non-US regulatory bodies.
Launched the BioShield Program to accelerate the potential discovery and validation of neutralizing human antibodies as an affordable solution to contain the spread of a viral pathogen or new emerging outbreaks.
Signed a preliminary agreement with Leidos, a FORTUNE 500 science and technology leader, to develop, and potentially obtain, FDA marketing approval of Ranpirnase for the systemic treatment of patients suffering from SARS-CoV-2, the virus that causes COVID-19.
The Company’s complete financial results are available in the Company’s Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on August 6, 2020, which is available at www.sec.gov and on the Company’s website.

On August 7, 2020 Arvinas, Inc. (Nasdaq: ARVN), a clinical-stage biotechnology company creating a new class of drugs based on targeted protein degradation, reported that Ron Peck, M.D., Chief Medical Officer, will participate in a fireside chat at the 2020 Wedbush PacGrow Virtual Healthcare Conference on Tuesday, August 11 at 10:20 a.m. ET (Press release, Arvinas, AUG 7, 2020, View Source [SID1234563157]).

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A live audio webcast of the presentation will be available here and on the Company’s website at www.arvinas.com. A replay of the webcast will be archived on the Arvinas website for 30 days following the presentation

On August 7, 2020 Replimune Group, Inc. (NASDAQ: REPL), a biotechnology company developing oncolytic immuno-gene therapies derived from its Immulytic platform, reported financial results for the fiscal first quarter ended June 30, 2020 and provided a business update (Press release, Replimune, AUG 7, 2020, View Source [SID1234563156]).

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"In the past few months, we have made important progress in demonstrating the power of our Immulytic platform to deliver meaningful new treatment options for a range of cancers," said Philip Astley-Sparke, CEO of Replimune. "In June, we provided an interim update from the Phase 2 portion of the Phase 1/2 clinical trial of RP1 in combination with Opdivo, establishing clinical proof of principle for RP1 in immune-responsive tumor types, including in patients with anti-PD1 refractory disease. In particular, we believe the data generated bode well for our registration directed programs already underway with RP1 in CSCC and anti-PD1 refractory melanoma. Following a successful follow-on offering, Replimune is now well-financed to advance and expand our pipeline with many exciting milestones ahead of us. We look forward to providing an initial data readout from RP2 later this year, as well as initiating clinical development with RP3 as we seek to establish our products more broadly, beyond immune-responsive tumor types, as a cornerstone of immuno-oncology."

Recent Events and Corporate Updates

Presented interim clinical data from the Phase 2 portion of the Phase 1/2 clinical trial of RP1 in combination with Opdivo in non-melanoma and melanoma skin cancers that continue to support the clinical programs in both cutaneous squamous cell carcinoma (CSCC) and anti-PD1 refractory melanoma.

In CSCC, six of seven evaluable patients demonstrated ongoing response, with four of these six patients having ongoing complete responses (CRs).

Provided interim data evaluating treatment with RP1 in combination with Opdivo in 16 patients with anti-PD1 refractory cutaneous melanoma. Five of the 16 patients at the data cut-off had met the formal criteria for response, including four who had previously failed both anti-PD1 and anti-CTLA4 therapies, providing for a final response rate from this cohort of at least 31%.

Announced promising data of RP1 in combination with Opdivo in patients with anti-PD1 naïve cutaneous melanoma, mucosal melanoma and uveal melanoma.

Announced plans to enroll a new 30 patient cohort of anti-PD1 refractory NSCLC patients into the Phase 2 portion of the clinical trial of RP1 combined with Opdivo.

A link to the data presented can be found here.

Strengthened management team with the appointment of Andrea Pirzkall, M.D. as Chief Medical Officer. Dr. Pirzkall brings to Replimune a track record of drug development success in the biotechnology and pharmaceutical industry, particularly in immuno-oncology, together with multi-disciplinary clinical experience at the intersection of radiology and oncology. Dr. Pirzkall previously served as Executive Director of Clinical Development at BeiGene, Ltd., a publicly traded commercial-stage biotechnology company with responsibility for the development of tislelizumab (anti-PD1) and led successful pivotal trials in squamous and non-squamous cell lung cancer, prior to which Dr. Pirzkall spent 10 years at Genentech in roles of increasing responsibility.

Extended anticipated cash runway to mid-2023. In June 2020, the Company raised gross proceeds of $115 million through a public offering of common stock and pre-funded warrants. The Company believes that the existing cash and cash equivalents and short-term investments, along with a limited use of debt, will enable the Company to fund additional studies and the overall operating plan to mid-2023.

COVID-19 potential impact on milestones: Enrollment into our clinical trials, such as the Company’s clinical trial of RP1 in solid organ transplant patients with CSCC, representing a highly immunocompromised patient population, has been slower than expected, which the Company attributes to the global pandemic. As the clinical sites continue to evaluate their capacity to treat patients, the Company could see additional impact in the second half of 2020 across its programs. The Company has not yet experienced delays that would require an update to previous guidance.
Program Highlights

Replimune is currently developing three oncolytic immuno-gene therapies derived from its Immulytic platform. The Company’s first clinical product candidate, RP1, is a proprietary new strain of herpes simplex virus armed with a gene encoding a potent fusogenic protein (GALV-GP-R), intended to enhance tumor killing potency, immunogenic cell death and the activation of systemic anti-tumor immune responses and a gene encoding the cytokine GM-CSF. In addition to expressing GALV-GP-R and GM-CSF, the Company’s second clinical candidate, RP2, also expresses a genetically encoded anti-CTLA-4 antibody-like molecule intended to block the inhibition of the initiation of immune response caused by CTLA-4. RP3 is a further armed oncolytic immuno-gene therapy which additionally expresses two immune co-stimulatory activating ligands – CD40L and 4-1BBL – together with anti-CTLA-4 and GALV-GP-R. CD40L activates CD40, with the goal of achieving broad activation of both innate and adaptive immunity, and 4-1BBL activates 4-1BB (CD137), intended to promote the expansion of cellular and memory immune responses.

RP1 in combination with Libtayo in cutaneous squamous cell carcinoma (CSCC): The Company is actively enrolling patients into the 240-patient registration-directed Phase 2, randomized, controlled clinical trial in the US and Australia, with clinical trial sites in Canada and Europe expected to open later in the year.

RP1 in combination with Opdivo in melanoma, non-melanoma skin cancers, and MSI-H/dMMR tumors: The clinical trial remains on track with enrollment and accrual of the initial melanoma cohort completing in the first half of 2020 and patients expected to be fully accrued from the non-melanoma skin cancer (NMSC) cohort by the end of 2020. The Company is accumulating data from the MSI-H/dMMR cohort to inform a decision as to whether to pursue MSI-H/dMMR tumors into registration-directed development in 2021.

RP1 in combination with Opdivo in anti-PD-1 refractory melanoma: The Company initiated recruitment into a new registration-directed 125-patient cohort in the Phase 2 clinical trial of RP1 in combination with Opdivo in February 2020 and is currently enrolling patients.

RP1 in anti-PD1 refractory patients with non-small cell lung cancer (NSCLC): In June 2020, the Company announced its plans to add a 30 patient cohort of anti-PD1 refractory patients with NSCLC to the RP1 combined with Opdivo clinical trial. The Company plans to initiate enrollment into this cohort later this year.

RP1 as monotherapy in solid organ transplant recipients with CSCC: The Company initiated enrollment into a 30 patient Phase 1b clinical trial to assess the safety and efficacy of RP1 in liver and kidney transplant recipients with recurrent CSCC in May 2020.

RP2 alone and in combination with Opdivo: The Company plans to present initial safety and efficacy data from the ongoing Phase 1 clinical trial evaluating RP2 alone and in combination with Opdivo by the end of 2020.

RP3 alone and in combination with anti-PD-1 therapy: The Phase 1 clinical trial of RP3 alone and in combination with anti-PD-1 therapy remains on track to initiate in 2020.
Financial Highlights

Cash Position: As of June 30, 2020, cash, cash equivalents and short-term investments were $261.8 million, as compared to $168.6 million as of March 31, 2020. This increase was primarily related to $109.5 million in net proceeds from financing activities offset by cash utilized in fiscal quarter one operating activities largely associated with advancing our expanded clinical development plan.

The Company believes that the existing cash and cash equivalents and short-term investments, along with a limited use of debt, will enable the Company to fund additional studies and the overall operating plan to mid-2023.
R&D Expenses: Research and development expenses were $12.2 million for the first quarter ended June 30, 2020, as compared to $7.5 million for the first quarter ended June 30, 2019. This increase was primarily due to increased clinical and manufacturing expenses driven by the Company’s lead programs and increased personnel expenses. Research and development expenses included $1.0 million in stock-based compensation expenses for the first quarter ended June 30, 2020.

G&A Expenses: General and administrative expenses were $5.7 million for the first quarter ended June 30, 2020, as compared to $3.5 million for the first quarter ended June 30, 2019. The increase was primarily driven by personnel-related costs, professional fees, and facility expansion. General and administrative expenses included $1.5 million in stock-based compensation expenses for the first quarter ended June 30, 2020.

Net Loss: Net loss was $17.5 million for the first quarter ended June 30, 2020, as compared to a net loss of $9.5 million for the first quarter ended June 30, 2019.
About RP1

RP1 is Replimune’s lead Immulytic product candidate and is based on a proprietary new strain of herpes simplex virus engineered to maximize tumor killing potency, the immunogenicity of tumor cell death and the activation of a systemic anti-tumor immune response.

About RP2 & RP3

RP2 and RP3 are derivatives of RP1 that express additional proteins. RP2 expresses an anti-CTLA-4 antibody-like molecule and RP3 additionally expresses a pair of optimized immune co-stimulatory pathway ligands. These therapeutics are intended to provide targeted and potent delivery to the sites of immune response initiation in the tumor and draining lymph nodes, with the goal of focusing systemic immune-based efficacy on tumors and limiting off-target toxicity.

On August 7, 2020 Heat Biologics, Inc. ("Heat") (NASDAQ:HTBX), a clinical-stage biopharmaceutical company focused on developing first-in-class therapies to modulate the immune system, including multiple oncology product candidates and a novel COVID-19 vaccine, reportedfinancial, clinical and operational updates for the second quarter ended June 30, 2020 (Press release, Heat Biologics, AUG 7, 2020, View Source [SID1234563155]).

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Jeff Wolf, Chief Executive Officer of Heat Biologics, commented, "This quarter we achieved significant milestones in advancing our unique COVID-19 vaccine program, which we are developing in collaboration with researchers at University of Miami. Specifically, our latest pre-clinical studies demonstrated immunogenicity proof-of-concept, validating that the selected vaccine antigen may be appropriate for human testing. Preclinical testing demonstrated expansion of antibody-supporting CD4+, and virus killing CD8+ T-cells in the lungs of the animals, a major site for COVID-19 infection. We believe this platform may play an important role as a standalone vaccine or in combination with other antibody-generating vaccines to provide broad cellular T-cell and humoral protection against COVID-19, particularly for elderly patients and those with underlying health conditions who have an increased risk of complications and death from COVID-19."

"Additionally, we established a partnership with Waisman Biomanufacturing to manufacture our COVID-19 vaccine for anticipated Phase 1 trials in humans. We believe that the unique capabilities and previous expertise gained working with Waisman on our cancer programs, HS-110 and HS-130 that are based upon the same gp96 platform, will help shorten the development timeline for our COVID-19 vaccine."

"We recently presented our latest data for HS-110 in combination with Nivolumab in our Phase 2 lung cancer trial at the 2020 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting. Importantly, this data demonstrated a strong survival benefit in a cohort of previously treated checkpoint inhibitor (CPI) naïve patients with advanced non-small cell lung cancer (NSCLC) and further reinforced the potential utility of HS-110 in combination with a checkpoint inhibitor as a frontline treatment for NSCLC."

"We also continue to accelerate PTX-35, our potential first-in-class T-cell co-stimulatory antibody, through clinical development. Specifically, we announced patient enrollment in our first-in-human clinical trial in multiple solid tumors following FDA clearance of our Investigational New Drug (IND) application. This study is expected to enroll up to 30 patients with advanced solid tumors refractory to standard of care."

"We have continued to strengthen our balance sheet, and now have over $100 million in cash and short-term investments as of August 6, 2020, which should provide us with the resources to significantly advance our clinical programs," concluded Mr. Wolf.

Second Quarter 2020 Financial Results

Recognized $0.6 million of grant revenue for qualified expenditures under the CPRIT grant compared to $0.3 million for the quarter ended June 30, 2019. The increase in grant revenue in the current-year period primarily reflects the expected timing of completion of deliveries under the current phase of the contract. As of June 30, 2020, we had deferred revenue of $1.9 million for CPRIT proceeds received but for which the costs had not been incurred or the conditions of the award had not been met.
Research and development expenses decreased approximately 17.6% to $2.8 million for the three months ended June 30, 2020 compared to $3.4 million for the quarter ended June 30, 2019.
General and administrative expense was $1.8 million and $1.9 million for the quarters ending June 30, 2020 and 2019. General and administrative expenses primarily consist of personnel costs, including stock-based compensation expense, and consulting expenses to manage the business.
Net loss attributable to Heat Biologics was approximately $4.5 million, or ($0.05) per basic and diluted share for the quarter ended June 30, 2020 compared to a net loss of approximately of $4.8 million, or ($0.14) per basic and diluted share for the quarter ended June 30, 2019.
As of June 30, 2020, the Company had approximately $47 million in cash, cash equivalents and short investments.

On August 7, 2020 Aclaris Therapeutics, Inc. (NASDAQ: ACRS), a clinical-stage biopharmaceutical company focused on developing novel drug candidates for immuno-inflammatory diseases, reported its financial results for the second quarter of 2020 and provided research and development (R&D) and business highlights (Press release, Aclaris Therapeutics, AUG 7, 2020, View Source [SID1234563154]).

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"As the pandemic evolves, our team has continued to work hard to make the appropriate business adjustments, advance our pipeline and execute through these uncertain times," said Dr. Neal Walker, President and CEO of Aclaris. "In the second quarter, we dosed the first subject in our Phase 2a trial of ATI-450 as a potential treatment for moderate to severe rheumatoid arthritis. We are also proud to be participating in the effort to find effective therapeutics for COVID-19 by supporting an investigator-initiated clinical trial of ATI-450 for cytokine release syndrome in hospitalized patients with COVID-19 and the first subject has been dosed in this trial. In addition, we are progressing with the first-in-human trial of ATI-1777 in patients with moderate to severe atopic dermatitis. We look forward to continuing to execute on our clinical development plans."

R&D Highlights:
The global outbreak of COVID-19 continues to rapidly evolve and has caused and may continue to cause Aclaris to experience disruptions that could impact the timing of its regulatory and research and development activities listed below.

ATI-450, an investigational oral small molecule MK2 inhibitor compound:
ATI-450-RA-201: An ongoing Phase 2a trial to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of ATI-450 in subjects with moderate to severe rheumatoid arthritis.
This trial was initiated in March 2020. Due to the COVID-19 pandemic, Aclaris temporarily paused enrollment. Aclaris resumed enrolling subjects, and the first subject was dosed, in May 2020. At this time, Aclaris is actively recruiting for this trial. Given the continuing evolution of the COVID-19 pandemic, Aclaris now anticipates reporting data from this trial in the first half of 2021.
ATI-450-CAPS-201: Aclaris expects to initiate a Phase 2a clinical trial of ATI-450 in cryopyrin-associated periodic syndrome (CAPS), an IL1β-driven disease, in the second half of 2020.
IIT-2020-ATI-450-COVID-19: An ongoing investigator-initiated Phase 2a, randomized, double-blind, placebo-controlled clinical trial to investigate the safety and efficacy of ATI-450, when used in addition to standard of care therapy, as a potential treatment for cytokine release syndrome in 36 hospitalized patients with COVID-19. Aclaris is providing funding and clinical drug supply to the University of Kansas Medical Center (KUMC), the sponsor of the trial. The primary endpoint in this trial is the proportion of subjects who are free from respiratory failure by day 14.
The first subject was dosed in August 2020.
ATI-1777, an investigational topical "soft" Janus Kinase (JAK) 1/3 inhibitor compound:
Aclaris submitted an Investigational New Drug (IND) Application for ATI-1777 for the treatment of moderate to severe atopic dermatitis (AD) in June 2020 and now plans to progress to the first-in-human trial of ATI-1777 in subjects with moderate to severe AD.
ATI-1777-AD-201: Aclaris expects to initiate a Phase 1/2a multicenter, randomized, double-blind, vehicle-controlled trial to investigate the safety, tolerability, pharmacokinetics and efficacy of topically applied ATI-1777 in subjects with moderate to severe AD in the second half of 2020. The primary endpoint will assess efficacy at four weeks.
ATI-2138, an investigational oral ITK/TXK/JAK3 (ITJ) inhibitor compound:
Aclaris is developing ATI-2138 as a potential treatment for psoriasis and/or inflammatory bowel disease and expects to submit an IND for ATI-2138 in 2021.
Business Development Highlights:

Aclaris continues to pursue strategic alternatives, including seeking partners for:
A-101 45% Topical Solution: to obtain regulatory approval and commercialize A-101 45% Topical Solution, an investigational compound, as a potential treatment for common warts (verruca vulgaris);
ATI-501 & ATI-502: to further develop, obtain regulatory approval and commercialize ATI-501 (oral) and ATI-502 (topical), investigational JAK 1/3 inhibitor compounds, as potential treatments for alopecia; and
ESKATA: to commercialize ESKATA (hydrogen peroxide) topical solution, 40% (w/w).
Financial Highlights:

Liquidity and Capital Resources

As of June 30, 2020, Aclaris had aggregate cash, cash equivalents and marketable securities of $68.1 million compared to $75.0 million as of December 31, 2019. For the quarter and six months ended June 30, 2020, net cash used in operating activities was $10.8 million and $17.6 million, respectively. As of June 30, 2020, Aclaris had approximately 42.7 million shares of common stock outstanding.

Aclaris anticipates that its cash, cash equivalents and marketable securities as of June 30, 2020 will be sufficient to fund its operations through the first quarter of 2022, without giving effect to any potential business development transactions or financing activities.

Second Quarter 2020 and Year-to-Date Financial Results

The accompanying consolidated statements of operations and selected consolidated balance sheet data have been recast for all periods presented to reflect the assets, liabilities, revenue and expenses related to Aclaris’ commercial products as discontinued operations.
Net loss was $11.6 million for the second quarter of 2020, compared to $49.9 million for the second quarter of 2019, and was $27.2 million for the six months ended June 30, 2020, compared to $87.4 million for the six months ended June 30, 2019.
Total costs and expenses from continuing operations for the second quarter of 2020 were $13.4 million, compared to $44.5 million for the second quarter of 2019, and were $30.3 million for the six months ended June 30, 2020, compared to $72.8 million for the six months ended June 30, 2019.
Total costs and expenses in the second quarter of 2020 included non-cash stock-based compensation expense of $3.3 million, compared to $4.6 million in the prior year period.
Total costs and expenses for the six months ended June 30, 2020 included non-cash stock-based compensation expense of $6.8 million, compared to $8.9 million in the prior year period.
Recorded a non-cash goodwill impairment charge of $18.5 million for the quarter and six months ended June 30, 2019. There were no impairment charges in either period in 2020.
R&D expenses were $6.5 million and $15.9 million for the quarter and six months ended June 30, 2020, respectively, compared to $17.5 million and $37.2 million for the quarter and six months ended June 30, 2019, respectively.
The quarter-over-quarter decrease of $11.1 million was primarily the result of the substantial completion of Aclaris’ various Phase 2 clinical trials of ATI-501 and ATI-502 and two pivotal Phase 3 clinical trials of A-101 45% Topical Solution in 2019, and the corresponding reduction in personnel costs to support these programs.
General and administrative expenses were $5.6 million and $11.8 million for the quarter and six months ended June 30, 2020, respectively, compared to $7.5 million and $14.9 million for the quarter and six months ended June 30, 2019, respectively.
The quarter-over-quarter decrease of $1.9 million was primarily the result of lower personnel costs resulting from the Company’s decision to discontinue commercial operations in September 2019.
Loss from continuing operations was $11.6 million and $26.9 million for the quarter and six months ended June 30, 2020, respectively, compared to $43.7 million and $71.0 million for the quarter and six months ended June 30, 2019, respectively. Loss from discontinued operations was $27,000 and $0.3 million for the quarter and six months ended June 30, 2020, respectively, compared to $6.2 million and $16.5 million for the quarter and six months ended June 30, 2019, respectively.