On August 12, 2020 Viela Bio (Nasdaq:VIE), a biotechnology company dedicated to the discovery, development and commercialization of novel treatments for autoimmune and severe inflammatory diseases, reported financial results and provided program highlights for the second quarter ended June 30, 2020 (Press release, Viela Bio, AUG 12, 2020, View Source [SID1234563512]).

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"Viela had another productive quarter marked by the U.S. FDA approval of UPLIZNA—also known as inebilizumab—in the U.S.," said Bing Yao, Ph.D., Chief Executive Officer at Viela Bio. "In parallel, we continue to advance the development of inebilizumab in the U.S. in additional indications such as myasthenia gravis and IgG4-related disease."

Added Dr. Yao: "Beyond UPLIZNA, we continue to make progress throughout our entire pipeline. We recently reported positive interim Phase 1b data from our ongoing trial with VIB7734 and selected systemic lupus erythematosus as our area of focus for a Phase 2 trial. Separately, we are planning to initiate a Phase 1 trial with this product candidate in patients with COVID-19-related acute lung injury. Looking toward our objectives for the rest of the year and beyond, we are well-positioned having recently raised gross proceeds of approximately $169 million in an underwritten public offering, which will support our clinical and commercial execution and extends our cash runway into 2023."

PROGRAM HIGHLIGHTS

UPLIZNA (inebilizumab-cdon)

UPLIZNA Commercial Launch Underway
On June 11, the U.S. Food and Drug Administration (FDA) approved UPLIZNA for the treatment of adult patients with neuromyelitis optica spectrum disorder (NMOSD) who are anti-AQP4 antibody positive as a twice-a-year maintenance regimen following initial doses. UPLIZNA is the first and only treatment designed to deplete B cells that is approved by the FDA for this patient population. Commercial launch activities are currently underway, with focus on both centers of excellence and community neurologists throughout the U.S.

Viela Preparing for Additional Clinical Trials with Inebilizumab
Phase 3 trials of inebilizumab in myasthenia gravis and IgG4-related disease are projected to initiate in Q4 2020. The Company is also conducting a Phase 2 trial for kidney transplant desensitization, which due to the COVID-19 pandemic, remains voluntarily paused.
VIB4920

Viela Resumes New Patient Enrollment in Ongoing Trial with VIB4920
Viela is currently conducting a Phase 2b trial with VIB4920 in Sjögren’s syndrome as well as a Phase 2 trial in patients with kidney transplant rejection. Due to the COVID-19 pandemic, new patient enrollment in both trials had been voluntarily paused, but has recently resumed in the kidney transplant rejection trial, with enrollment in the Sjögren’s trial anticipated to resume in Q4 2020. The Company continues to explore other potential indications associated with the CD40/CD40L co-stimulatory pathway for potential additional clinical studies.
VIB7734

Company Reports Interim Results from Phase 1b trial with VIB7734 and Selects SLE for Phase 2 Trial
In May, the Company reported positive interim data from a Phase 1b study with VIB7734, its novel anti-ILT7 therapy. Interim findings indicated safety and tolerability comparable to placebo control across all cohorts with the final data analysis expected to be completed in Q3 2020. Based on the positive interim results, as well as additional efficacy and biomarker data from cohort 3, the Company has selected systemic lupus erythematosus (SLE) as the lead indication of a planned Phase 2 trial.
Viela Prepares for New Study in COVID-19-Related Acute Lung Injury
Viela is planning to initiate a Phase 1 study in Q3 2020 with VIB7734 in patients with COVID-19-related acute lung injury. Results from this study are anticipated in Q1 2021, at which time the Company will decide whether to pursue additional clinical trials in this indication.
FINANCIAL RESULTS

For the second quarter of 2020, Viela reported a net loss of $38.9 million, compared to a net loss of $5.5 million for the second quarter of 2019. As of June 30, 2020, Viela had $448.4 million in cash, cash equivalents, and investments and no outstanding debt. In June 2020, Viela completed an underwritten public offering of its common stock and issued and sold 3,600,000 shares of common stock, at a public offering price of $47.00 per share, for aggregate gross proceeds of $169.2 million.

Research and development expenses were $25.4 million for the second quarter of 2020, which include $1.4 million of non-cash stock-based compensation expenses.

General and administrative expenses were $14.4 million for the second quarter of 2020, which include $1.7 million of non-cash stock-based compensation expenses.

Total operating expenses for the second quarter of 2020 totaled $39.8 million, compared to $6.1 million for the second quarter of 2019. Non-cash share-based compensation expenses totaled $3.1 million for the second quarter of 2020, compared to $0.6 million for the second quarter of 2019.
Conference Call and Webcast
The Company will host a live webcast and conference call to discuss financial results and program highlights for the second quarter of 2020 today at 5:00 p.m. EDT.

The webcast will be accessible on the Events & Presentations page of Viela Bio’s website. Individuals can participate in the conference call by dialing (877) 783-8848 (domestic) or (631) 350-0960 (international) and referring to conference ID #: 4945969

The archived webcast will be available for replay on the Viela Bio website approximately two hours after the event.

On August 12, 2020 Cyclacel Pharmaceuticals, Inc. (NASDAQ: CYCC, NASDAQ: CYCCP; "Cyclacel" or the "Company"), a biopharmaceutical company developing innovative medicines based on cancer cell biology, reported its financial results for the second quarter 2020 and business highlights, including an update on its progress with fadraciclib, Cyclacel’s novel CDK2/9 inhibitor (Press release, Cyclacel, AUG 12, 2020, View Source [SID1234563511]).

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The Company’s net loss applicable to common shareholders for the three months ended June 30, 2020 was $2.2 million. As of June 30, 2020, cash and cash equivalents totaled $25.3 million. Based on current spending, the Company estimates it has sufficient resources to fund planned operations, including research and development, through the end of 2022.

"We believe fadraciclib is establishing a leadership position among MCL1 suppressing compounds in development. Our recent, peer-reviewed publication elaborates the mechanistic rationale for fadraciclib as an anti-cancer therapy signifying the benefits of inhibiting CDK2 and CDK9, two complementary cancer pathways," said Spiro Rombotis, President and Chief Executive Officer. "We continue to be encouraged by observations of deep partial response and prolonged stable disease with tumor shrinkage as an intravenously administered monotherapy in patients with advanced solid tumors and antileukemic activity in combination with venetoclax. In parallel with evaluating fadraciclib in certain leukemias, we are executing a precision medicine strategy to evaluate the compound in patients with solid tumors with study enrollment expected to begin by the first quarter of 2021. As the global pandemic continues to unfold, our priorities are to ensure patient and employee safety and support efforts to stem COVID-19 disease as part of our corporate social responsibility. Despite the challenges we remain committed to our strategy of building an innovative pipeline addressing the rising problem of cancer resistance and achieving our clinical milestones to drive shareholder value."

Key Corporate Highlights

Announced publication of a peer-reviewed study of fadraciclib, in PLOS ONE. The publication, authored by scientists from Cyclacel and The Institute of Cancer Research, London, describes the discovery of fadraciclib and shows its ability to target CDK2 and CDK9, leading to broad therapeutic potential.

CYC065-01 Phase 1 part 2 single agent i.v. – As previously reported a heavily pretreated patient with MCL1 amplified endometrial cancer achieved a radiographically confirmed partial response (PR) after a month and a half on fadraciclib at 213mg. This patient continues on therapy for more than a year and reduction in her target tumor lesions is 83%. An additional patient with cyclin E amplified ovarian cancer achieved stable disease with 29% tumor shrinkage after approximately four months at 213mg. We have submitted data for publication at a cancer conference later in the year.

Based on data thus far, we are designing a Phase 1/2 precision medicine study to further evaluate fadraciclib as monotherapy and in combinations in patients with advanced solid tumors.

CYC065-01 Phase 1 part 3 single agent p.o. – Initial data from an oral capsule formulation of fadraciclib given once daily to four patients with advanced solid tumors demonstrated a predictable pharmacokinetic profile closely overlapping the intravenous form with encouraging exposure levels.

CYC065-03 Phase 1 fadraciclib i.v. and venetoclax p.o. in AML/MDS – We have dosed 11 heavily pretreated patients with relapsed/refractory (R/R) AML in five dose levels up to 200 mg/m2 of fadraciclib in combination with venetoclax. Evidence of anticancer activity has been observed in four out of eleven patients treated. Preclinical data in AML suggest that targeting both MCL1 and BCL2 may be more beneficial than inhibiting either protein alone.

CYC065-02 Phase 1 fadraciclib i.v. and venetoclax p.o. in CLL – We have dosed 5 patients with R/R CLL in four dose levels up to 150 mg/m2 of fadraciclib in combination with venetoclax. Evidence of anticancer activity has been observed in two patients who achieved MRD negativity on the combination. Preclinical data suggest that targeting both BCL2 and MCL1 in CLL may be more beneficial than single agent treatment in this setting as well.

CYC682-11 Phase 1 part 2 sapacitabine p.o. and venetoclax p.o. – We have enrolled 12 patients in a dose escalation study in our DNA Damage Response (DDR) program evaluating an oral combination of sapacitabine and venetoclax in patients with R/R AML/MDS. Two patients, previously treated with combination therapies including hypomethylating agents, have achieved 5 and 6 cycles of treatment respectively. Sapacitabine is a nucleoside analogue that is active in AML and MDS R/R to prior therapy such as cytarabine or hypomethylating agents. Preclinical data demonstrated synergy of sapacitabine with BCL2 inhibition, which may offer an effective, oral treatment regimen for patients who have failed front-line therapy.

CYC140-01 Phase 1 CYC140 i.v. – We have enrolled 6 patients in our first-in-human, dose escalation study evaluating CYC140 in patients with advanced leukemias. CYC140 is a small molecule, selective polo-like-kinase 1 (PLK1) inhibitor that has demonstrated potent and selective target inhibition and high activity in xenograft models of human cancers. In addition to hematological malignancies we are evaluating studies of CYC140 in solid tumors.
More information on our clinical trials can be found here.

Key Business Objectives

Report updated fadraciclib Phase 1 safety and efficacy data with frequent i.v. dosing schedule in patients with advanced solid cancers;
Report initial safety and PK data from Phase 1 study of fadraciclib oral formulation;
Treat first patient in fadraciclib Phase 1/2 precision medicine study;
Report initial data from fadraciclib-venetoclax Phase 1 study in R/R AML/MDS & CLL;
Report initial data from sapacitabine-venetoclax Phase 1 study in R/R AML/MDS;
Report initial data from CYC140 Phase 1 first-in-human study in R/R leukemias; and
Report data from Phase 1b/2 sapacitabine-olaparib IST in BRCA mutant metastatic breast cancer when reported by the investigators.
Financial Highlights

As of June 30, 2020, cash and cash equivalents totaled $25.3 million, compared to $11.9 million as of December 31, 2019. The increase of $13.4 million was primarily due to net proceeds of $18.3 million from an equity financing in April 2020 and net cash used in operating activities of $4.7 million. There were no revenues for each of the three months ended June 30, 2020 and 2019.

Research and development expenses were $1.2 million for each of the three months ended June 30, 2020 and 2019. Research and development expenses relating to transcriptional regulation increased by approximately $0.2 million for the three months ended June 30, 2020 as we continue to progress the clinical evaluation of fadraciclib.

General and administrative expenses for the three months ended June 30, 2020 were $1.3 million, compared to $1.2 million for the same period of the previous year.

Total other income, net, for the three months ended June 30, 2020 was $20,000, compared to $0.2 million for the same period of the previous year. The decrease of approximately $0.2 million for the three months ended June 30, 2020 is primarily related to income received under an Asset Purchase Agreement with Thermo Fisher Scientific Inc.

United Kingdom research & development tax credits were $0.3 million for each of the three months ended June 30, 2020 and 2019.

Net loss for the three months ended June 30, 2020 was $2.2 million compared to $1.8 million for the same period in 2019.

The Company estimates that cash resources of $25.3 million as of June 30, 2020 will fund currently planned programs through 2022.

Conference call information:

US/Canada call: (877) 493-9121 / international call: (973) 582-2750

US/Canada archive: (800) 585-8367 / international archive: (404) 537-3406

Code for live and archived conference call is 2477369.

For the live and archived webcast, please visit the Corporate Presentations page on the Cyclacel website at www.cyclacel.com. The webcast will be archived for 90 days and the audio replay for 7 days.

On August 12, 2020 Onconova Therapeutics, Inc. (NASDAQ: ONTX), a Phase 3 stage biopharmaceutical company focused on discovering and developing novel products to treat cancer, with an initial focus on myelodysplastic syndromes (MDS), reported financial results for the quarter ended June 30, 2020, and provided a business update (Press release, Onconova, AUG 12, 2020, View Source [SID1234563510]).

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"With INSPIRE recently meeting the number of survival events required by the study’s statistical analysis plan, we anticipate reporting topline data by the end of the current quarter," said Steven M. Fruchtman, M.D., President and Chief Executive Officer. "If the data readout demonstrates a significant prolongation of survival for patients randomized to intravenous rigosertib, we believe this could represent a significant medical advancement for patients with higher-risk MDS. Following such data readout, we anticipate submitting a New Drug Application to the FDA to seek approval to commercially launch rigosertib."

Second Quarter 2020 Developments and Recent Highlights

Pivotal Phase 3 INSPIRE trial reached the required number of survival events for data analysis
Initiation of and first patient enrollment in a Phase 1/2a study exploring an oral rigosertib plus nivolumab combination in KRAS+ lung cancer patients
Applications submitted for rigosertib to participate in federally funded human studies in COVID-19 disease based on early-stage preclinical evidence of rigosertib inhibition of SARS-COV-2 replication
Election of life sciences industry veteran Terri Shoemaker to the Company’s Board of Directors
Nasdaq compliance regained with achievement of dollar bid price listing requirement
Recent Presentations and Scientific Publications

Presentation of updated aggregated baseline genomic data from HMA-failure patients screened and randomized for the INSPIRE trial, in e-poster form, at the virtual 25th Annual European Hematology Association (EHA) (Free EHA Whitepaper) Congress
Publication in Molecular Cell of preclinical data supporting rigosertib’s mechanism of action as a targeted anticancer agent
Publication of Phase 1 results in Leukemia Research for oral rigosertib in combination with azacitidine in higher-risk (HR)-MDS and acute leukemia
Additional Expected Company Milestones

Announcement of topline INSPIRE results by the end of the third quarter of 2020, with data presentation at a major medical meeting later in the year
FDA review of Phase 2/3 trial protocol of oral rigosertib plus azacitidine in hypomethylating agent (HMA) naïve HR-MDS
Federal funding agencies review of applications for clinical trials with rigosertib in SARS-COV-2 disease
Virtual presentation at the 2nd Annual RAS-Targeted Drug Development Summit September 14-16, 2020
US IND submission planned for 4Q 2020 for next generation CDK 4/6 + ARK5 inhibitor, ON 123300, with first in-human Phase 1 trial anticipated in 1Q 2021, and Phase 1 study commencement in China planned for 2H 2020
Anticipated launch of Early Access Program with Inceptua Medicines Group in 2H 2020
Expansion of rigosertib investigator-initiated development program to encompass additional RAS-driven cancers
Second Quarter 2020 Financial Results
Cash and cash equivalents as of June 30, 2020, totaled $27.2 million, compared to $22.7 million as of December 31, 2019. Exercises of common stock warrants from our financing transactions in November and December 2019 have added $9.8 million to our balance sheet since January 1, 2020, and as of August 12, 2020, we have 183,578,267 common shares outstanding. Of the 12.6 million common stock warrants which remain outstanding at August 12, 2020, 80% were in-the-money. Based on current projections, the Company expects that its cash and cash equivalents will be sufficient to fund ongoing trials and operations into the fourth quarter of 2021.

Net loss was $7.4 million for the quarter ended June 30, 2020, compared to $3.6 million for the quarter ended June 30, 2019. Research and development expenses were $4.8 million for the quarter ended June 30, 2020 and $3.9 million for the comparable period in 2019. General and administrative expenses were $2.6 million for the quarter ended June 30, 2020 and $1.8 million for the comparable period in 2019.

Conference Call and Webcast Information
The Company will host a conference call today, August 12, 2020, at 4:30 p.m. Eastern Time. Interested parties who wish to participate in the conference call may do so by dialing (855) 428-5741 for domestic and (210) 229-8823 for international callers and using conference ID 2875654.

To facilitate an on-time conference call start, Onconova recommends that participants dial in 15 minutes before the 4:30 p.m. ET start time.

Those interested in listening to the conference call via the internet may do so by visiting the investors and media page on the company’s website at www.onconova.com and clicking on the webcast link. In addition to the live webcast, a replay will be available on the Onconova website for 90 days following the call.

On August 12, 2020 Salarius Pharmaceuticals, Inc. (Nasdaq: SLRX), a clinical-stage biotechnology company targeting cancers caused by dysregulated gene expression, reported its corporate and financial results for the second quarter ended June 30, 2020 (Press release, Salarius Pharmaceuticals, AUG 12, 2020, View Source [SID1234563509]).

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Financial Highlights:

$6.2 million gross proceeds in underwritten public offering closed August 3, 2020
Three-month period ended June 30, 2020 net loss per common share – basic and diluted – of $0.13, compared to $0.30 for the same period ended June 30, 2019
Total cash and cash equivalents of $7.2 million as of June 30, 2020
o Up to $9.10 million remains available under the Cancer Prevention and Research Institute of Texas (CPRIT) Contract, subject to meeting certain requirements or approvals
Recent Business and Corporate Highlights:

Ewing sarcoma clinical trial expanded to include Ewing-related sarcomas supported by clinical observations including observation of seclidemstat activity in a patient with refractory Ewing sarcoma
Ewing sarcoma phase 1/2 clinical trial and advanced solid tumor (AST) phase 1/2 clinical trial continue to enroll patients during COVID-19
Salarius presented seclidemstat data to Pediatric Oncology Subcommittee of the FDA’s Oncologic Drugs Advisory Committee (ODAC)
European Patent Office (EPO) issued Patent EP2744330 for seclidemstat
"The second quarter of 2020 and recent weeks have proven to be a period of substantial progress for Salarius, highlighted by several events that we believe affirm the company’s growth strategy and demonstrate the value of seclidemstat as a potential treatment for Ewing sarcoma and other cancers," said David Arthur, President and CEO of Salarius. "These highlights included a new EU patent for seclidemstat, our data presentation at ODAC and the ongoing progress of our clinical trials in advanced solid tumors and Ewing sarcoma; the latter of which is now being expanded to include Ewing-related sarcomas where seclidemstat has potential to demonstrate activity."

Mr. Arthur concluded, "Patient enrollment in our clinical trials for seclidemstat in Ewing sarcoma and advanced solid tumors continue and we expect to reach important development milestones this year and in 2021. These milestones support our ultimate goal to maximize the potential of seclidemstat and bring hope to patients and their families fighting rare, pediatric and other cancers. To that end, we believe Salarius remains well-capitalized including up to $9.1 million in non-dilutive funding that remains available from the CPRIT award."

Three-Month Financial Results:

For the three-month period ended June 30, 2020, Salarius’ reported net loss was $1.8 million, or $0.13 per basic and diluted share, compared to a net loss of $0.9 million, or $0.30 per basic and diluted share for the same period in 2019. The loss before other income for the three-month period ended June 30, 2020 increased by $1.0 million compared to the loss before other income for the same time span last year, which was primarily due to an increase of $0.6 million in research and development expenses resulting from increased clinical trial expenses and drug manufacturing costs. Salarius also reported a net increase of $0.7 million in general and administrative costs resulting from Salarius’ transformation into a public company and increased personnel expenses during the current quarter.

As of June 30, 2020, total cash, cash equivalents and restricted cash were $7.2 million, compared to $3.7 million at year-end 2019. Increases in cash balances result from the Company’s public offering of stock in the first quarter 2020.

$6.2 Million Underwritten Public Offering

On August 3, 2020, Salarius completed an underwritten public offering with total gross proceeds of approximately $6.2 million, prior to deducting underwriting discounts and commissions and offering expenses payable by Salarius. Salarius intends to use the net proceeds from the offering to fund the expansion of the Ewing sarcoma clinical trial and ongoing company operations.

Ewing Sarcoma Clinical Trial Expanded

On July 29, 2020, Salarius announced the expansion of its ongoing Phase 1/2 clinical trial of seclidemstat in Ewing sarcoma to include additional select sarcomas that share a similar biology to Ewing sarcoma, also known as Ewing-related sarcomas. Sarcomas of interest include myxoid liposarcoma, desmoplastic round cell tumors and other sarcomas that harbor similar FET family gene rearrangements to Ewing sarcoma, i.e. Ewing-related sarcomas.

These Ewing-related sarcomas were chosen based on their underlying biology as well as preclinical data and early clinical observations involving seclidemstat that suggest the drug may demonstrate activity and may have applicability in several sarcomas that share key characteristics of Ewing sarcoma.

The planned amendment to the ongoing trial will allow up to 30 patients with Ewing-related sarcomas to enroll in the trial’s upcoming dose-expansion phase, which is in addition to the 20 Ewing sarcoma patients also planned to be treated in the dose-expansion phase.

Conference Call Information:

Salarius Pharmaceuticals will host a conference call and live audio webcast on Wednesday, August 12, 2020, at 4:30 p.m. ET, to discuss its corporate and financial results for the second quarter 2020. Interested participants and investors may access the conference call by dialing either:

(833) 423-0481 (U.S.)
(918) 922-2375 (international)
Conference ID:9367616
An audio webcast will be accessible via the Investors Events and Presentations section of the Company’s website View Source An archive of the webcast will remain available for 90 days beginning at approximately 5:30 p.m. ET, on August 12, 2020.

On August 12, 2020 NGM Biopharmaceuticals, Inc. (NGM) (Nasdaq: NGM), a biotechnology company focused on discovering and developing transformative therapeutics for patients, reported financial results for the period ending June 30, 2020 (Press release, NGM Biopharmaceuticals, AUG 12, 2020, View Source [SID1234563508]).

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"We continue to progress across our clinical-stage programs spanning liver, retinal and metabolic diseases as well as cancer, despite the ongoing challenges presented by the COVID-19 pandemic, thanks to the dedication and tireless efforts of our team, and the ongoing support and commitment from our clinical collaborators," said David J. Woodhouse, Ph.D., Chief Executive Officer at NGM. "We’re thrilled to have achieved our most recent clinical milestone, the advancement of NGM621 into Phase 2 development for the treatment of patients with GA. GA is a highly prevalent and progressive retinal degenerative disease that can have a devastating, irreversible impact on patients’ vision and quality of life. Based on NGM621’s novel profile as a complement C3 inhibitory monoclonal antibody, we believe it has the potential to be an important treatment option for this significantly underserved patient population. It is gratifying to now have two programs in Phase 2 clinical development in two distinct therapeutic areas, both for the treatment of serious unmet needs."

Dr. Woodhouse further commented, "Within the diverse NASH development landscape, we are pleased with the impressive and highly consistent clinical performance of aldafermin to date, with robust, placebo-controlled data demonstrating statistically significant dual activity in reversing fibrosis and resolving NASH. Our Phase 2b ALPINE 2/3 and ALPINE 4 clinical studies remain on track, and we are hard at work on Phase 3 readiness in anticipation of an ALPINE 2/3 topline data readout in the first half of next year."

Key Second Quarter and Recent Highlights

Liver and metabolic disease

Continued enrollment in Phase 2b ALPINE 2/3 study of aldafermin in NASH. NGM has continued enrollment in the Phase 2b ALPINE 2/3 clinical study of aldafermin in patients with biopsy-confirmed NASH and stage 2 or 3 (F2-F3) liver fibrosis. The 24-week study is designed to enroll approximately 150 patients and will assess the efficacy, safety and tolerability of 0.3 mg, 1 mg and 3 mg doses of aldafermin compared to placebo. Enrollment activities have increased since our first quarter update, and we reiterate our expectation of announcing topline data from the study in the first half of 2021.

Continued enrollment in Phase 2b ALPINE 4 study of aldafermin in NASH patients with compensated cirrhosis. NGM has continued enrollment in the Phase 2b ALPINE 4 study of aldafermin in patients with biopsy-confirmed compensated NASH cirrhosis (F4). The 48-week study is designed to enroll approximately 150 patients and will assess the efficacy, safety and tolerability of 0.3 mg, 1 mg and 3 mg doses of aldafermin compared to placebo.

Data from 24-week double‑blind, randomized, placebo-controlled Phase 2 study (Cohort 4) of aldafermin in NASH patients published in Gastroenterology. Comprehensive findings and analysis from the 24-week Cohort 4 reported by NGM in February 2020 were published this month in the journal Gastroenterology. The 24-week double-blind, randomized, placebo-controlled Phase 2 clinical study demonstrated statistically significant dual activity in reversing fibrosis and resolving NASH. In the study, aldafermin continued to demonstrate a favorable tolerability profile. Cohort 4 was the final reported cohort from NGM’s adaptive Phase 2 clinical study of aldafermin in NASH, and the results observed in Cohort 4 were consistent with data from the three previous cohorts.

Continued enrollment in Phase 1 study of NGM395 in overweight and obese healthy adults. NGM has continued to enroll patients in a Phase 1 single ascending dose clinical study evaluating the safety, tolerability and pharmacokinetics of NGM395, a long-acting growth differentiation factor 15 (GDF15) analog, in overweight and obese but otherwise healthy adults.

Completed Phase 1 study of NGM217 in adults with autoimmune diabetes. We recently completed a Phase 1 study of NGM217, an antibody binding an undisclosed target, which assessed the safety, tolerability and pharmacokinetics of NGM217 in adults with autoimmune diabetes. The study demonstrated that NGM217 was well tolerated. However, as NGM continues to advance multiple clinical‑stage programs and anticipates advancing earlier-stage discovery programs into clinical development, the company has decided to suspend activities related to NGM217 to concentrate its resources on the development of other product candidates.
Retinal disease

Initiated Phase 2 CATALINA study of NGM621 in patients with GA. As announced in July 2020, NGM initiated the Phase 2 CATALINA study, a multicenter, randomized, double-masked, sham-controlled clinical trial to evaluate the safety and efficacy of intravitreal injections (IVT) of NGM621 in patients with GA secondary to age-related macular degeneration (AMD). Dysregulated activation of the complement system, a key component of the immune system, has been implicated in the onset and progression of GA. NGM621 is a humanized IgG1 monoclonal antibody engineered to potently inhibit activity of complement C3 with the treatment goal of reducing disease progression in patients with GA, and with the potential for extended every eight week dosing without PEGylation. Designed as a Phase 3-enabling study, the Phase 2 CATALINA study is expected to enroll 240 patients diagnosed with GA in one or both eyes.

NGM also successfully completed a first-in-human open-label Phase 1 study in which treatment with single- and multiple-dose IVT injections of NGM621 in patients with GA was well tolerated, supporting advancement to the Phase 2 CATALINA study. NGM plans to present the data from the Phase 1 study at the American Academy of Ophthalmology (AAO) 2020 Virtual Annual Meeting from November 13-15, 2020. In addition, NGM presented NGM621 preclinical findings at The Association for Research in Vision and Ophthalmology Annual Meeting, held virtually in June 2020. The presentations are available on NGM’s website.
Cancer

Continued enrollment in Phase 1a/1b study of NGM120 in patients with cancer anorexia/cachexia syndrome (CACS) and cancer. NGM continues to enroll patients in a Phase 1a/1b clinical study to evaluate NGM120, a first-in-class antagonistic antibody that binds glial cell-derived neurotrophic factor receptor alpha-like (GFRAL), and inhibits GDF15 signaling, for the potential treatment of CACS and cancer. CACS is the uncontrolled wasting of both skeletal muscle and fat that is a common co-morbidity of cancer and is associated with shortened survival in cancer patients.
Corporate

Expanded leadership with key management team and board appointments. NGM announced the appointment of a new executive team member, Siobhan Nolan Mangini, as Chief Financial Officer effective July 13, 2020 and announced the appointment of Carole Ho, M.D. to its Board of Directors. Dr. Ho currently serves as Chief Medical Officer and Head of Development at Denali Therapeutics.
Merck Collaboration

Merck has a one-time option to license NGM pipeline programs, other than NGM’s wholly-owned programs aldafermin and NGM395, following human proof-of-concept trials under the terms of the companies’ ongoing strategic collaboration. Upon exercising any such option, Merck would lead global product development and commercialization for the resulting products, if approved. Prior to Merck initiating a Phase 3 study for a licensed program, NGM may elect to either receive milestone and royalty payments or, in certain cases, to co-fund development and participate in a global cost and revenue share arrangement of up to 50%. The agreement also provides NGM with the option to participate in the co-promotion of any co-funded program in the United States. In January 2019, Merck exercised its first option under the collaboration to license NGM313, also referred to as MK‑3655.

Second Quarter Financial Results

For the quarter ended June 30, 2020, NGM reported a net loss of $25.6 million compared to a net loss of $7.7 million for the corresponding period in 2019.

Related party revenue from our collaboration with Merck for the quarter ended June 30, 2020 was $19.8 million compared to $25.3 million for the corresponding period in 2019. The decrease in related party revenue was primarily attributable to the completion of all remaining obligations associated with the upfront payment at the conclusion of the initial five-year term of the Merck collaboration.

Research and development expenses for the quarter ended June 30, 2020 were $38.5 million compared to $28.8 million for the corresponding period in 2019. The increase in research and development expenses was mainly attributable to increases in external research and development expenses associated with the advancement of NGM’s growing pipeline, primarily expenses related to our aldafermin, NGM621 and NGM395 programs, and personnel-related expenses driven by increased headcount.

General and administrative expenses for the quarter ended June 30, 2020 were $6.8 million compared to $6.2 million for the corresponding period in 2019. The increase in general and administrative expenses was primarily attributable to increases in personnel-related expenses driven by increased headcount and legal expenses to support our operations as a public company.

Cash, cash equivalents and short-term marketable securities were $312.1 million as of June 30, 2020, compared to $344.5 million as of December 31, 2019.