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Intellia Therapeutics Announces First Quarter 2020 Financial Results

On May 7, 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 first quarter ended March 31, 2020 (Press release, Intellia Therapeutics, MAY 7, 2020, View Source [SID1234557316]).

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"At Intellia, our mission is to develop curative, CRISPR/Cas9-based treatments for severe diseases. I am grateful to our team for remaining steadfast in our commitment to patients and putting us in the position to deliver on our goals despite the challenging circumstances presented by the global COVID-19 pandemic," said Intellia President and Chief Executive Officer John Leonard, M.D. "We look forward to advancing NTLA-2001 into clinical testing and dosing ATTR patients with the first systemically delivered CRISPR/Cas9-based therapy in the second half of 2020. Additionally, we continue to advance our full-spectrum pipeline, including IND-enabling activities for NTLA-5001, our engineered TCR-T cell therapy candidate for AML, and the nomination of NTLA-2002 as our development candidate for the treatment of HAE."

First Quarter 2020 and Recent Operational Highlights

ATTR Program: Intellia’s lead candidate, NTLA-2001, is designed to apply its in vivo liver knockout approach for the treatment of transthyretin amyloidosis (ATTR) in a single course of treatment. The Company has manufactured clinical-scale materials for a Phase 1 study of NTLA-2001 and remains on track to submit an Investigational New Drug application (IND) or IND-equivalent for this program in mid-2020. NTLA-2001 is anticipated to be the first systemically delivered CRISPR/Cas9 therapy to enter the clinic. Subject to the impact of COVID-19, the Company plans to dose the first patient in the second half of 2020. NTLA-2001 is part of a co-development/co-promotion (Co/Co) agreement between Intellia, which is the lead development and commercialization party, and Regeneron Pharmaceuticals, Inc. (Regeneron).
AML Program: NTLA-5001 for the treatment of acute myeloid leukemia (AML) is Intellia’s first T cell receptor (TCR)-T cell development candidate, which targets the Wilms’ Tumor 1 (WT1) antigen. The Company’s approach aims to develop a broadly applicable treatment for AML patients, regardless of mutational subtypes of a patient’s leukemia. As presented at Keystone Symposia’s Engineering the Genome Conference in February 2020, Intellia demonstrated that its CRISPR/Cas9-enabled approach results in an engineered T cell product capable of specific and potent killing of primary AML blasts. Intellia is continuing to advance IND-enabling activities, including process development to support clinical T cell manufacturing. The Company is on track to submit an IND or IND-equivalent for NTLA-5001 in the first half of 2021. Additional efforts are underway to evaluate the potential use of the WT1-targeted TCR construct to treat solid tumors.
HAE Program: Intellia has nominated its third development candidate, NTLA-2002 for the treatment of hereditary angioedema (HAE). Building on the modular lipid nanoparticle (LNP) delivery system developed for the ATTR program, NTLA-2002 is designed to knock out the prekallikrein B1 (KLKB1) gene in the liver after a single course of treatment. As part of an ongoing durability study of its lead LNP formulation in support of NTLA-2002, Intellia has now demonstrated six months of sustained therapeutically relevant reduction of serum kallikrein levels and activity following a single dose in non-human primates. Intellia expects to submit an IND or IND-equivalent for NTLA-2002 in the second half of 2021. NTLA-2002 is subject to an option by Regeneron to enter into a Co/Co agreement, which must be exercised within a limited time period after development candidate selection. Intellia would be the lead party if the option is exercised.
Modular Platform: Intellia continues to advance its differentiated genome editing and delivery strategies, including targeted insertion and consecutive editing, across its in vivo and ex vivo efforts. These platform capabilities enable the removal and/or restoration of a gene’s function in developing treatments for life-threatening diseases. The in vivo research builds on data previously shared by the Company demonstrating the first CRISPR-mediated, targeted transgene insertion in the liver of non-human primates, which generated circulating human FIX protein at or above normal levels. At the upcoming American Society of Gene and Cell Therapy (ASGCT) (Free ASGCT Whitepaper) Annual Meeting, taking place virtually from May 12 – 15, 2020, the Company will present preclinical data related to certain programs and ex vivo platform capabilities. This will include an oral presentation featuring Intellia’s enhanced CRISPR/Cas9-based T cell engineering platform capable of highly efficient editing of multiple genes with levels of translocations indistinguishable from background levels, and favorable cell product attributes including high viability and expansion potential. This improved T cell engineering process has been incorporated into the NTLA-5001 program.
Novartis Collaboration: As announced in March 2020, the U.S. Food and Drug Administration (FDA) has accepted the IND application submitted by Novartis Institutes for BioMedical Research (Novartis), for a CRISPR/Cas9-based engineered cell therapy for the treatment of sickle cell disease (SCD) developed under collaboration with Intellia. The Phase 1/2 clinical trial will begin investigating OTQ923 in adult patients with severe complications of SCD. Novartis’ IND application triggered a milestone payment to Intellia, and the Company is eligible to receive additional downstream success-based milestones and royalties.
Upcoming Events

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

ASGCT 23rd Annual Meeting, May 12 – 15, Virtual
Jefferies Global Healthcare Conference, June 3, Virtual
Upcoming Milestones

The Company has set forth the following for pipeline progression:

ATTR:
Submit an IND or IND-equivalent for NTLA-2001 in mid-2020
Subject to the impact of COVID-19, plan to dose first patient in 2H 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
Modular Platform Advancements:
Present preclinical data at upcoming ASGCT (Free ASGCT Whitepaper) Annual Meeting
First Quarter 2020 Financial Results

Cash Position: Cash, cash equivalents and marketable securities were $250.3 million as of March 31, 2020, compared to $284.5 million as of December 31, 2019. The decrease was driven by cash used to fund operations of approximately $40.1 million, which was offset in part by $4.5 million of net equity proceeds raised from the Company’s "At the Market" (ATM) agreement, $1.0 million of funding received under the Novartis collaboration, and $0.3 million in proceeds from employee-based stock plans.
Collaboration Revenue: Collaboration revenue increased by $2.5 million to $12.9 million during the first quarter of 2020, compared to $10.4 million during the first quarter of 2019. The increase in collaboration revenue in 2020 was mainly driven by the $5.0 million milestone payment earned from Novartis for the IND submission of OTQ923.
R&D Expenses: Research and development expenses increased by approximately $10.9 million to $34.7 million during the first quarter of 2020, compared to $23.7 million during the first quarter of 2019. This increase was primarily driven by the advancement of our lead programs, research personnel growth to support these programs, as well as the expansion of the development organization.
G&A Expenses: General and administrative expenses increased by $0.8 million to $11.3 million during the first quarter of 2020, compared to $10.5 million during the first quarter of 2019. This increase was primarily driven by an increase in intellectual property related expenses due to increased patent-related activity.
Net Loss: The Company’s net loss was $31.8 million for the first quarter of 2020, compared to $21.9 million during the first quarter of 2019.
Financial Guidance

Intellia expects that its cash, cash equivalents and marketable securities as of March 31, 2020 will enable the Company to fund its anticipated operating expenses and capital expenditure requirements at least through the end of 2021. This expectation excludes any strategic use of capital not currently in the Company’s base-case planning assumptions.

Conference Call to Discuss First Quarter 2020 Earnings

The Company will discuss these results on a conference call today, May 7, 2020, at 8 a.m. ET.

To join the call:

U.S. callers should dial 1-877-317-6789 and use conference ID# 10141541, approximately five minutes before the call.
International callers should dial 1-412-317-6789 and use conference ID# 10141541, approximately five minutes before the 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 May 7, 2020 at 12 p.m. ET.

Magenta Therapeutics Reports Recent Business Highlights and First Quarter Financial Results

On May 7, 2020 Magenta Therapeutics (Nasdaq: MGTA), a clinical-stage biotechnology company developing novel medicines to bring the curative power of immune reset to more patients, reported recent business highlights and financial results for the first quarter ended March 31, 2020 (Press release, Magenta Therapeutics, MAY 7, 2020, View Source [SID1234557315]).

"The first quarter of 2020 has shown Magenta to be well-positioned to advance our programs and to weather unexpected obstacles. Magenta continues to execute and progress our pipeline, and we remain committed wholeheartedly to our patients, their families, our employees and our business partners," said Jason Gardner, D.Phil., President and Chief Executive Officer, Magenta. "In this first quarter, Magenta has showcased significant clinical and preclinical results, and we are building on these results to advance quickly."

Recent Business Highlights:

MGTA-117 lead clinical candidate for conditioning for stem cell transplant and gene therapy demonstrates broad therapeutic index; advancing MGTA-117 to deliver initial clinical data in 2021. Data presented at the Transplant and Cellular Therapies (TCT) conference in February 2020 demonstrated that MGTA-117’s optimized linker payload resulted in potent depletion of stem and progenitor cells with an improved therapeutic index of 30 (range for approved ADCs at this stage of development has been two- to six- fold). The ADC is advancing in GMP manufacture. Magenta will also present data in an oral presentation at the upcoming American Society of Gene & Cell Therapy (ASGCT) (Free ASGCT Whitepaper) annual conference, to be held May 12-15, demonstrating that a single dose of CD117-ADC enables hematopoietic stem cell (HSC)-based gene therapy in non-human primates.

The Company is scaling up manufacturing of MGTA-117 and expects to complete investigational new drug (IND)-enabling studies in 2020. This program is on track to complete GLP toxicology studies and progress GMP manufacturing in 2020, as well as to deliver initial clinical data in 2021.

Announced research and clinical collaboration agreement with AVROBIO to evaluate potential utility of MGTA-117 targeted ADC for conditioning patients with one or more AVROBIO lentiviral gene therapies. The collaboration will combine Magenta’s leadership in ADC-based conditioning with AVROBIO’s expertise in lentiviral gene therapies and will further the two companies’ shared mission to allow patients to live free from disease. Under the collaboration, Magenta and AVROBIO will jointly evaluate MGTA-117 in conjunction with one or more of AVROBIO’s investigational gene therapies. Magenta will retain all commercial rights to MGTA-117. AVROBIO will retain all commercial rights to its gene therapies and will be responsible for the clinical trial costs related to the evaluation of MGTA-117 with AVROBIO’s gene therapies.

The Phase 1 trial of MGTA-145, Magenta’s first-line stem cell mobilization therapy, met all primary and secondary endpoints, demonstrating rapid, same-day first line stem cell mobilization and collection in healthy volunteers, and enrollment in the renal pharmacokinetic study is complete. At TCT in February, Magenta presented data showing MGTA-145 was safe and well tolerated as a single agent and in combination with plerixafor and demonstrated rapid, same-day mobilization and collection of sufficient numbers of stem cells to enable a successful transplant.

Based on the results of the Phase 1 study, Magenta intends to initiate multiple Phase 2 trials of MGTA-145 which may be staggered over the course of this year due to clinical trial impacts from COVID-19. The Phase 2 trials will include both allogeneic and autologous transplant settings and will evaluate mobilization and collection of functional cells and engraftment of the cells after transplant to rebuild the immune system. There is potential for the Company to present initial Phase 2 data on MGTA-145 in 2020.

At the upcoming ASGCT (Free ASGCT Whitepaper) conference, Magenta will present two sets of preclinical data on MGTA-145. In one study, MGTA-145 plus plerixafor was shown to be a rapid, reliable, efficient and G-CSF-free method to obtain high numbers of HSCs, including HSCs that were gene-modified with robust and durable engraftment, which could be used to improve HSC collection and autologous gene therapy outcomes for a variety of therapeutic indications. In a separate preclinical study, MGTA-145 plus plerixafor was shown to serve as an efficient same-day mobilization regimen for in vivo gene therapy of HSCs, which could be applicable in patients with sickle cell disease and other genetic disorders.

IND-enabling work on CD45-ADC for immune system reset will progress in 2020, with lead antibody identified. Magenta is developing targeted ADCs designed to precisely remove the disease-causing cells in the body without the need for chemotherapy or radiation. Magenta’s CD45-ADC program targets CD45, a protein expressed on immune cells and stem cells and is designed to remove the cells that cause autoimmune diseases in order to enable curative immune reset.

Enrollment timelines for the MGTA-456 Phase 2 trial in inherited metabolic disorders have been shifted into 2021, due to COVID-19-related impacts. The trial remains open with seven of 12 patients enrolled and continued longer term follow-up on these patients will be conducted. Sixteen patients have been enrolled in the Phase 2 trial of MGTA-456 in patients with blood cancers at the University of Minnesota, and this trial is currently expected to complete enrollment in 2020.

Expanded senior leadership team. In February 2020, Magenta announced it had expanded its senior leadership with two new strategic hires, Kristen Stants as Chief People Officer, and Li Malmberg, Ph.D., as Senior Vice President, Head of Manufacturing. In April 2020, Magenta announced the promotion of John Davis Jr., M.D., M.P.H., M.S. to Head of Research and Development and Chief Medical Officer.

COVID-19-related operational changes. Magenta has taken important steps to help ensure the safety of employees and their families and to reduce the spread of COVID-19 in the Cambridge community. In early March, Magenta created an internal, cross-functional COVID-19 response team, focused on employee safety and business continuity, to monitor closely the evolving situation and advise on the Company’s response. Magenta has established a work-from-home policy for all employees, other than those performing or supporting business-critical laboratory-based experiments, such as certain members of the Company’s laboratory and facilities staff. For those employees, Magenta has implemented stringent safety measures designed to comply with applicable federal, state and local guidelines instituted in response to the COVID-19 pandemic. Magenta has also maintained frequent communication with its partners and clinical sites as the COVID-19 situation has progressed.

Financial Results:

Cash Position: Cash, cash equivalents and marketable securities as of March 31, 2020, were $130.4 million, compared to $145.7 million on December 31, 2019. Magenta anticipates that its cash, cash equivalents and marketable securities will be sufficient to fund operations and capital expenditures into the first quarter of 2022.

Research and Development Expenses: Research and development expenses were $14.0 million in the first quarter of 2020, compared to $10.5 million in the first quarter of 2019. The increase was driven primarily by investments in manufacturing related to our conditioning programs and MGTA-456, increases in personnel to support the Company’s operations as a clinical-stage company and certain clinical activities for MGTA-145.

General and Administrative Expenses: General and administrative expenses were $7.3 million for the first quarter of 2020, compared to $5.8 million for the first quarter of 2019. The increase was primarily due to an increase in personnel and facilities associated with the growth of the Company, in addition to consulting work related to pre-commercialization activities.

Net Loss: Net loss was $20.0 million for the first quarter of 2020, compared to net loss of $14.8 million for the first quarter of 2019.

Conference Call Details:

To access the call, please reference the dial-in details below. In addition, a live webcast will be available, and a playback of the call will be available on the Magenta Therapeutics website at View Source for 90 days following the call.

Kura Oncology to Present at BofA Securities Virtual Health Care Conference 2020

On May 7, 2020 Kura Oncology, Inc. (Nasdaq: KURA), a clinical-stage biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer, reported its participation at the BofA Securities Virtual Healthcare Conference 2020 (Press release, Kura Oncology, MAY 7, 2020, View Source [SID1234557314]). Troy Wilson, Ph.D., J.D., President and Chief Executive Officer, is scheduled to present an overview of the company on Tuesday, May 12, 2020 at 3:40 p.m. ET / 12:40 p.m. PT. The virtual conference will be held from May 12-14, 2020.

A live audio webcast of the presentation will be available in the Investors section of Kura’s website at www.kuraoncology.com, with an archived replay available for 30 days following the event.

Selecta Biosciences Reports First Quarter 2020 Financial Results

On May 7, 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 first quarter ended March 31, 2020 (Press release, Selecta Biosciences, MAY 7, 2020, View Source [SID1234557313]).

"To date, Selecta has been able to navigate many of the challenges presented by the COVID-19 pandemic, and as such, the ongoing COMPARE clinical trial of SEL-212 in chronic refractory gout is still on schedule, and we continue to expect to announce topline data in the third quarter of this year. However, we continue to recognize the inherent unpredictability of this ongoing situation. During this time, we have made the health and safety of our patients and healthcare providers the top priority, and we continue to work with our CRO and clinical sites to ensure that any risk posed to a patient or provider coming in for visits is properly mitigated," said Carsten Brunn, Ph.D., President and CEO of Selecta. "We have also continued to advance our operations in other critical areas, including preparations for the commencement of the Phase 3 trial of SEL-212, and collaborating with AskBio to advance our gene therapy program. We remain on track to enter the clinic under this collaboration by the end of the year."

Recent Highlights and Anticipated Upcoming Milestones:

Topline Results from COMPARE Clinical Trial Expected in the Third Quarter of 2020: The head-to-head COMPARE study of Selecta’s lead product candidate, SEL-212 (ImmTOR + pegadricase), vs. pegloticase is expected to readout on schedule, as the Company continues to work closely with the CRO and clinical sites to monitor patient follow-up in light of the COVID-19 pandemic. The trial is evaluating a once-monthly dose of SEL-212 compared to biweekly doses of pegloticase, with the primary endpoint of the maintenance of serum uric acid (SUA) levels of <6mg/dL at three and six months. The trial completed enrollment in December 2019, and as of April 2020, half of the patients had completed the study and all patients had reached three months of treatment.

Gene Therapy Program Expected to Enter the Clinic by the End of 2020: Selecta and its partner AskBio are jointly developing a broad portfolio of next-generation AAV gene therapies. This partnership will leverage the unique proprietary technology platforms of both companies with a human proof of concept trial to validate this portfolio of products and their potential for re-dosing in patients, which could represent a significant advancement in the gene therapy field. Selecta and AskBio anticipate entering the clinic by the end of 2020. Additionally, Selecta intends to advance its proprietary program in Ornithine Transcarbamylase (OTC) deficiency.
First Quarter 2020 Financial Results:

Cash Position: Selecta had $74.3 million in cash, cash equivalents, and restricted cash as of March 31, 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 will be sufficient to meet its operating requirements into the first quarter of 2021.

Net cash used in operating activities was $11.7 million for the first quarter of 2020, as compared to $20.2 million for the same period in 2019.

Research and Development Expenses: Research and development expenses for the first quarter 2020 were $14.7 million, which compares with $7.4 million for the same period in 2019. The increase in costs was primarily the result of expenses incurred for our Phase 2 COMPARE trial for SEL-212 and for our gene therapy program in collaboration with AskBio.

General and Administrative Expenses: General and administrative expenses for the first quarter 2020 were $4.1 million, which compares with $4.5 million for the same period in 2019. The reduction in costs was the result of reduced salaries, consulting and professional fees offset by increased stock compensation expense.

Net Loss: For the first quarter 2020, Selecta reported a net loss of $19.6 million, or $0.21 per share, compared to a net loss of $12.1 million, or $0.31 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 first 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 10138607. 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

MEI Pharma Reports Fiscal Third-Quarter 2020 Results and Recent Corporate Highlights

On May 7, 2020 MEI Pharma, Inc. (NASDAQ: MEIP) ("MEI"), a late-stage pharmaceutical company focused on advancing new therapies for cancer, reported results for its third quarter ended March 31, 2020 and highlighted recent corporate progress (Press release, MEI Pharma, MAY 7, 2020, View Source [SID1234557312]).

"Entering our fiscal fourth quarter, MEI is well positioned as we continue progress across our business, as highlighted by the recent grant of Fast Track designation by FDA for ME-401 and our newly announced global alliance with Kyowa Kirin," said Daniel P. Gold, Ph.D., president and chief executive officer of MEI Pharma. "These key achievements advance our efforts to optimize ME-401 to benefit patients across multiple B-cell malignancies inside and outside the U.S. and, importantly, the $100 million upfront payment from Kyowa Kirin helps extend our cash runway through at least 2023, including the ramp-up of MEI’s commercial activities and the potential launch of ME-401 in the U.S."

Dr. Gold continued: "With respect to the COVID-19 pandemic, all companies conducting clinical trials are facing a unique and challenging situation, and I’d like to thank all health care workers and other essential workers on the frontlines that are caring for the sick and keeping our society functioning. MEI will continue to be proactive in order to minimize the impact to our business, particularly the ongoing ME-401 TIDAL study. While the situation remains fluid, we will continue to focus on keeping the impact on TIDAL modest as we remain in close contact with all our sites to maintain patients on study and keep enrollment ongoing, even if at a somewhat reduced rate."

Recent Highlights

In April 2020, the Company entered a global license, development and commercialization agreement to further develop and commercialize MEI’s ME-401.
MEI and Kyowa Kirin will co-develop and co-promote ME-401 in the U.S.
MEI to book U.S. sales on 50-50 profit and cost sharing.
$100 million in an upfront cash payment to MEI.
$582.5 million in potential development, regulatory and commercial milestones
Kyowa Kirin obtains exclusive commercialization rights ex-U.S.
MEI to receive escalating tiered royalty payments from mid-teens on ex-U.S. sales.
In April 2020, Cheryl L. Cohen, former chief commercial officer of Medivation, Inc. and a product launch and commercialization veteran with over 25 years of service in the pharmaceutical and biotechnology industry, joined the Board of Directors.
In March 2020, the Company was granted Fast Track designation by the U.S. FDA for ME-401 for the treatment of adult patients with relapsed or refractory follicular lymphoma.
Fiscal Third-Quarter Fiscal Year 2020 Financial Results

As of March 31, 2020, MEI had $92.8 million in cash, cash equivalents and short-term investments, with no outstanding debt. Giving effect to the KKC Agreement, our cash, cash equivalents and short-term investments would have been $192.8 million.
For the three months ended March 31, 2020, cash used in operations was $10.3 million, compared to $11.3 million for the same period in 2019. For the nine months ending March 31, 2020, cash used in operations was $34.9 million, compared to $31.4 million for 2019. The increase primarily relates to costs associated with our clinical development programs.
Research and development expenses were $9.0 million for the quarter ended March 31, 2020, compared to $9.1 million for 2019. The decrease was primarily related to decreased drug manufacturing costs associated with ME-401, offset by increased clinical trial costs for the ME-401 TIDAL study and increased personnel and legal patent costs.
General and administrative expenses were $3.9 million for the quarter ended March 31, 2020, compared to $3.6 million for 2019. The increase primarily relates to increased headcount to support our activities.
Revenue was $1.2 million for the quarter ended March 31, 2020, compared to revenue of $1.2 million for the same period in 2019. Revenue resulted from the recognition of fees allocated to research and development activities related to the Helsinn and Kyowa Kirin Japan License Agreements.
Net loss was $4.3 million, or $0.04 per share, for the quarter ended March 31, 2020, compared to net loss of $17.4 million, or $0.24 per share for the same period in 2019. Net loss decreased primarily as a result of a non-cash gain in the current quarter and a non-cash expense in the prior quarter related to changes in the fair value of the warrant liability associated with the May 2018 financing. The Company had 105,998,677 shares of common stock outstanding as of March 31, 2020, compared with 71,280,660 shares as of March 31, 2019.
The adjusted net loss for the quarter ended March 31, 2020, excluding a non-cash gain related to changes in the fair value of the warrants (a non-GAAP measure), was $12.1 million, compared to an adjusted net loss of $12.2 million for 2019.