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ProMIS Neurosciences Announces Second Quarter 2019 Results

On August 13, 2019 ProMIS Neurosciences, Inc. (TSX: PMN) (OTCQB: ARFXF), a biotechnology company focused on the discovery and development of antibody therapeutics targeting toxic oligomers implicated in the development of neurodegenerative diseases, reported its operational and financial results for the three and six months ended June 30, 2019 (Press release, ProMIS Neurosciences, AUG 13, 2019, View Source [SID1234538627]).

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"Over the course of the first half of 2019, the breadth and depth of our unique discovery and development platform was further evidenced as ProMIS made considerable progress in expanding its portfolio of opportunities in neurodegenerative diseases," stated Eugene Williams, ProMIS’ Executive Chairman. "In the second quarter of this year, we were able to identify novel antibodies for Alzheimer’s disease (AD) with selectivity for the neurotoxic form of tau. This is in addition to the prior identification of antibody candidates selectively targeting toxic forms of alpha-synuclein (α-syn) for Parkinson’s disease (PD) and toxic, aggregated forms of TDP43 for amyotrophic lateral sclerosis (ALS)."

Narrated updates relating to ProMIS’ unique approach and capabilities can be found on the ProMIS website by clicking on the links below:

Click here for Chief Medical Officer Dr. James Kupiec’s update on demonstrating early proof-of-concept with biomarkers and focused patient populations
Click here for Chief Scientific Officer Dr. Neil Cashman’s overview of ProMIS’ unique capability to design and develop antibodies selectively targeting toxic misfolded proteins that are a root cause of neurodegenerative diseases
Click here for Chief Development Officer, Dr. Johanne Kaplan’s podium presentation at the Alzheimer’s Association International Conference (AAIC) 2019 showing selective targeting of toxic oligomers by PMN310, a monoclonal antibody rationally designed for greater therapeutic potency in AD
Corporate Highlights

In June 2019, the Company completed a private placement of 4,680,000 common share units at a price of $0.25 per unit resulting in gross proceeds of approximately $1,170,000 ($1,093,492 net of share issuance costs). Each unit consisted of one common share and one common share warrant. The common shares are subject to a four-month hold period from the date of issuance. Each warrant is exercisable into one common share at a price of $0.35 per share at any time for five years.
In May 2019, ProMIS announced the identification of novel antibodies for AD with selectivity for the neurotoxic form of tau. ProMIS leveraged its proprietary drug discovery and development platform to identify several novel antibodies that selectively bind toxic oligomers of tau. The platform produced antibodies that meet a key success factor for a viable Alzheimer’s disease therapy: the ability to selectively target the neurotoxic form of a protein, while sparing the normal forms of the protein, a challenge that has contributed to recent late-stage clinical trial failures. The platform not only generates high-quality antibody candidates, it delivers powerful, validated candidates in months versus years. Used in combination with new biomarkers for Alzheimer’s disease, researchers could dramatically improve the success and speed of future therapy development efforts.
In June 2019, ProMIS presented key data on monoclonal antibody PMN310 for AD at the Keystone Symposium on Neurodegenerative Diseases: New Insights and Therapeutic Opportunities. For nearly fifty years, the conference has attracted the world’s most accomplished researchers in neurodegenerative diseases to discuss future directions in therapy and care. ProMIS Chief Development Officer Dr. Johanne Kaplan presented data showing that PMN310 possesses superior selectivity for amyloid beta toxic oligomers and improved therapeutic potential compared with other amyloid beta-directed antibodies.
Scientific Advisory Board Appointment
In June 2019, the Company appointed C. Warren Olanow, MD, FRCPC, FAAN, FRCP(Hon) to its scientific advisory board (SAB). Dr. Olanow has dedicated his career to the study of neurodegeneration, particularly Parkinson’s disease, through his work in academia, scientific research, clinical trials and professional societies. He is the previous Henry P. and Georgette Goldschmidt Professor and Chairman of the Department of Neurology at the Mount Sinai School of Medicine in New York City and is presently Professor Emeritus in the Department of Neurology and in the Department of Neuroscience. He also serves as Chief Executive Officer of CLINTREX, a pharmaceutical advisory firm that has designed numerous clinical trials in neurodegenerative disease for the pharmaceutical industry.

Financial Results

Results of Operations – Three months ended June 30, 2019 and 2018

Net loss for the three months ended June 30, 2019 was $1,858,530, compared to a net loss of $2,214,861 for the three months ended June 30, 2018, respectively. Included in the net loss amount for the three months ended June 30, 2019 were non-cash expenses of $153,461, representing share-based compensation and amortization of an intangible asset, compared to $173,544 for the three months ended June 30, 2018. The decrease in the net loss in the three months ended June 30, 2019 reflects a decrease in costs associated with external contract research organizations for internal programs, patent costs and share-based compensation offset by increased consultant salaries and associated costs and general corporate expenditures.

Research and development expenses for the three months ended June 30, 2019 were $1,042,618, as compared to $1,531,075 in the three months ended June 30, 2018. The decrease in research and development expense for the three months ended June 30, 2019 is primarily attributed to decreased costs associated external contract research organizations for internal programs and patent costs offset by higher contracted research salaries and associated costs, and higher share-based compensation.

General and administrative expenses for the three months ended June 30, 2019 were $815,937, as compared to $683,786 in the three months ended June 30, 2018. The increase in general and administrative expense for the three months ended June 30, 2019 is primarily attributable to increased consultant salaries and associated costs and general corporate expenditures offset by decreased share-based compensation.

Results of Operations – Six months ended June 30, 2019 and 2018

Net loss for the six months ended June 30, 2019 was $4,305,107, compared to a net loss of $3,771,733 for the six months ended June 30, 2018, respectively. Included in the net loss amount for the six months ended June 30, 2019 were non-cash expenses of $417,334, representing share-based compensation and amortization of an intangible asset, compared to $502,555 for the six months ended June 30, 2018. The increase in the net loss in the six months ended June 30, 2019 reflects the costs associated with operating the Company’s AD therapeutics program, increased contracted research and consultant salaries and associated costs and general corporate expenditures.

Research and development expenses for the six months ended June 30, 2019 were $2,813,271, as compared to $2,229,082 in the six months ended June 30, 2018. The increase in research and development expense for the six months ended June 30, 2019 is primarily attributed to increased spending on external contract research organizations for internal programs, higher contracted research salaries and associated costs, and higher share-based compensation offset by reduced patent costs.

General and administrative expenses for the six months ended June 30, 2019 were $1,491,861, as compared to $1,542,656 in the six months ended June 30, 2018. The decrease in general and administrative expense for the six months ended June 30, 2019 is primarily attributable to decreased share-based compensation offset by increased consultant salaries and associated costs, general corporate expenditures and foreign exchange.

Outlook

The Company will continue to build on its unique, proprietary discovery and development platform to further characterize the potential benefits of its programs selectively targeting toxic aggregates of TDP43 and SOD1 in ALS, toxic forms of α-syn in PD and other α-syn-related disorders, and toxic forms of tau and amyloid beta in AD and other dementias to further support ongoing pharmaceutical partnering discussions.

CStone announces first patient dosed in China with BLU-667 for the global Phase I registrational study

On August 13, 2019 CStone Pharmaceuticals ("CStone", HKEX: 2616) reported the dosing of the first patient in China for the Phase I registrational study of BLU-667, which was discovered by the company’s partner Blueprint Medicines (Press release, CStone Pharmaceauticals, AUG 13, 2019, View Source [SID1234538606]). This clinical trial is a part of the ongoing, global Phase I ARROW trial that is designed to evaluate the overall response rate (ORR), duration of response, pharmacokinetics, pharmacodynamics and safety of BLU-667 in patients with RET-altered non-small cell lung cancer (NSCLC), medullary thyroid cancer (MTC) and other advanced solid tumors.

Among all malignant tumors, lung cancer has the highest incidence and mortality rates in the world. Due to heightened risk factors such as pollution and the prevalence of smoking in China, there are approximately 730,000 new cases of lung cancer and 610,000 lung cancer-related deaths reported in China each year[1]. NSCLC accounts for 80-85% of all lung cancers and RET fusions occur in approximately 1-2% of all NSCLC cases. Both platinum-based chemotherapy, the standard first-line treatment for RET-fusion NSCLC, and the second-line treatment of cytotoxic drugs or immune checkpoint inhibitor-based monotherapies offer limited efficacy. As a result, patients experience significant physical and psychological burdens and a lower quality of life.

Thyroid cancer is the most common type of endocrine cancer, and has shown rising incidence rates in recent years. There are approximately 90,000 new cases of thyroid cancer and 6,800 thyroid cancer-related deaths in China each year[1]. MTC accounts for 2-5% of all thyroid cancers, and RET mutations occur in nearly all hereditary MTC patients and approximately 50% of all sporadic MTC patients[2]. Currently there is no effective standard of care treatment approved for MTC patients in China.

BLU-667 is an orally available, highly selective and potent RET inhibitor. In June 2018, CStone obtained exclusive rights from Blueprint Medicines to develop and commercialize three therapeutic candidates, including BLU-667, in Mainland China, Hong Kong, Macau and Taiwan. Blueprint Medicines retains development and commercial rights to the three therapeutic candidates in the rest of the world.

In June 2019, Blueprint Medicines reported updated results from the ARROW clinical trial. BLU-667 showed durable anti-tumor activity regardless of RET-altered tumor type and was well-tolerated. As of the data cutoff date of April 28, 2019:

In 35 evaluable patients previously treated with platinum-based chemotherapy[3]. BLU-667 demonstrated an ORR of 60% (one complete response and 20 partial responses (PR); all responses were confirmed) and a disease control rate (DCR) of 100%.
In 16 evaluable RET-mutant MTC patients previously treated with cabozantinib or vandetanib, BLU-667 demonstrated an ORR of 63% (nine confirmed PRs, one PR pending confirmation) and a DCR of 94%[4] .
These patients with RET-fusion NSCLC and RET-mutant MTC received a starting dose of 400 mg once daily, which is the recommended Phase 2 dose. Across all patients, BLU-667 was well-tolerated and most adverse events reported by investigators were Grade 1 or 2.
Dr. Frank Jiang, Chairman and CEO of CStone, commented: "In China, lung cancer has the highest incidence rate and mortality rate among all malignancies. BLU-667 is an agent with great potential, and it could address the existing treatment gap for RET-fusion NSCLC and other RET-altered tumors in this country. I am pleased that through our dedicated efforts, we have successfully carried out the dosing of the first patient in China as a part of the ongoing, global registrational study."

"Precision medicines such as BLU-667 may be highly effective in treating genomically defined cancers and bring significant clinical benefit to patients. The global ARROW study has thus far produced promising clinical data. I am confident that with CStone’s effective execution, we can efficiently accelerate this clinical trial in China so that Chinese patients with RET-altered tumors can access this therapy as soon as possible," noted Dr. Jason Yang, CStone’s Chief Medical Officer.

[1]. Chen W, et al. Cancer statistics in China, 2015. CA Cancer J Clin 2016; 66(2): 115-32.

[2]. Priya SR, et al. Targeted Therapy for Medullary Thyroid Cancer: A Review. Front. Oncol. 7:238.

[3]. Justin F. Gainor, et al. Clinical activity and tolerability of BLU-667, a highly potent and selective RET inhibitor, in patients (pts) with advanced RET-fusion+ non-small cell lung cancer (NSCLC). 2019 ASCO (Free ASCO Whitepaper) Abstract 9008.

[4]. Matthew H. Taylor, et al. Activity and tolerability of BLU-667, a highly potent and selective RET inhibitor, in patients with advanced RET-altered thyroid cancers. 2019 ASCO (Free ASCO Whitepaper) Abstract 6018.

About BLU-667

BLU-667 is an investigational, once-daily oral precision therapy specifically designed for highly potent and selective targeting of oncogenic RET alterations. Blueprint Medicines is developing BLU-667 for the treatment of patients with RET-altered NSCLC, MTC and other solid tumors. The U.S. Food and Drug Administration has granted Breakthrough Therapy Designation to BLU-667 for the treatment of RET-fusion positive NSCLC that has progressed following platinum-based chemotherapy, and RET-mutation positive MTC that requires systemic treatment and for which there are no acceptable alternative treatments.

BLU-667 was designed by Blueprint Medicines’ research team, leveraging the company’s proprietary compound library. In preclinical studies, BLU-667 consistently demonstrated sub-nanomolar potency against the most common RET fusions, activating mutations and predicted resistance mutations. In addition, BLU-667 demonstrated markedly improved selectivity for RET compared to pharmacologically relevant kinases, including approximately 90-fold improved potency for RET versus VEGFR2. By suppressing primary and secondary mutants, BLU-667 has the potential to overcome and prevent the emergence of clinical resistance. Blueprint Medicines believes this approach will enable durable clinical responses across a diverse range of RET alterations, with a favorable safety profile.

APOLLO ENDOSURGERY, INC. ANNOUNCES CLOSING OF $20 MILLION PRIVATE PLACEMENT OF CONVERTIBLE DEBENTURES

On August 12, 2019 Apollo Endosurgery, Inc. ("Apollo") (Nasdaq:APEN), a global leader in less invasive medical devices for gastrointestinal and bariatric procedures, reported that it has closed its previously announced private placement of $20 million of unsecured convertible debentures to accredited and institutional investors (Press release, Lpath, AUG 12, 2019, View Source [SID1234538836]).

Interest on the debentures is payable semi-annually in common stock, or in kind in certain situations, at a rate per annum of 6.0%. At any time prior to maturity, the debentures are convertible into shares of Apollo’s common stock at a conversion price of $3.25, subject to certain customary adjustments. Upon the satisfaction of price and other conditions, Apollo has the right to force the conversion of the debentures. The debentures are unsecured and rank junior in right of payment to Apollo’s existing senior indebtedness. The outstanding principal and accrued interest on the debentures is due on the five-year anniversary of the issuance date. Apollo intends to use the proceeds from the sale of debentures for working capital and general corporate purposes.

Craig-Hallum Capital Group acted as the exclusive placement agent in connection with this transaction.

The securities sold in the private placement have not been registered under the Securities Act of 1933, as amended, or state securities laws and may not be offered or sold in the United States absent registration with the Securities and Exchange Commission (SEC) or an applicable exemption from such registration requirements. Apollo has agreed to file a registration statement with the SEC registering the resale of the shares of common stock underlying the convertible debentures.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful.

Prometic reports financial results for second quarter 2019

On August 12, 2019 Prometic Life Sciences Inc. (TSX: PLI) (OTCQX: PFSCF) ("Prometic" or "Company"), a biopharmaceutical company focused on developing novel therapeutics to treat unmet needs in patients with liver, respiratory and kidney disease, primarily in rare or orphan diseases, reported financial results for its fiscal 2019 second quarter ended June 30th 2019 (Press release, ProMetic Life Sciences, AUG 12, 2019, https://resources.prometic.com/latest-content/prometic-reports-financial-results-for-second-quarter-2019 [SID1234538645]). All amounts are in thousands of Canadian dollars and adjusted to reflect the reverse share consolidation, except where otherwise noted.

"During the second quarter, we were able to complete a series of financial transactions to stabilize and improve our financial situation at Prometic, and we will look to strengthen our balance sheet further in 2019 as our ongoing business development activities are brought to a conclusion," said Kenneth Galbraith, Prometic’s Chief Executive Officer. "We are now focused on progressing the development of our novel products, Ryplazim, PBI-4050 and PBI-4547 to address serious unmet patient needs in life threatening diseases. We look forward to sharing more about our progress in clinical development throughout 2019 and 2020."

Management Appointments

Effective September 1, 2019, Ms. Murielle Lortie, currently Vice President – Finance, will be promoted to Chief Financial Officer of the Company and Ms. Marie Iskra, currently Associate General Counsel, will be promoted to General Counsel for the Company. Mr. Patrick Sartore and Mr. Bruce Pritchard will continue to focus on their roles as Chief Operating Officer, North America and Chief Operating Officer, International, respectively.

"I am very pleased to welcome Murielle and Marie to the leadership team as I have been impressed by their contributions to the Company during my tenure as CEO, and look forward to their increased role in driving growth for Prometic in the years ahead. Their appointments will also allow Patrick and Bruce to increase their focus on the achievement of the key goals to drive shareholder value in both the near-term and long-term", said Mr. Galbraith.

Second Quarter Financial Results – Overview

Prometic’s cash position in the second quarter of 2019 substantially improved as a result of a series of related arrangements to restructure Prometic’s outstanding indebtedness, reduce its interest and certain other payment obligations, and raise sufficient cash to build a robust balance sheet to fund the next phase of Prometic’s development (collectively the "Refinancing Transactions"):

$114.4 million (US$87 million) aggregate gross proceeds were raised through a combination of a private placement offering of Common Shares led by Consonance Capital Management ("Consonance") and a concurrent equity rights offering ("Rights Offering") to shareholders of Prometic at a price of $15.21 per Common Share (the "Transaction Price");
Approximately $228.9 million (US$173 million) of the outstanding debt owned by Structured Alpha LP ("SALP") was converted into Common Shares at the Transaction Price, comprising all but $10 million of SALP’s outstanding debt;
The adjustment of the per warrant exercise price of certain outstanding Common Share purchase warrants of Prometic held by SALP to the Transaction Price (the "Warrant Repricing"); and
A share consolidation on the basis of one post-consolidation Common Share for every one thousand pre-consolidation Common Shares was completed on July 5, 2019 in anticipation of a filing for listing of the Company’s Common Shares on NASDAQ.
Current near-term priorities for the Company’s leadership team are as follows:

Completing the necessary manufacturing and related activities to allow for submission in H1-2020 to the FDA of an amendment to the Company’s BLA seeking regulatory approval for Ryplazim .
The filing and approval of an Investigational New Drug application ("IND") to enable the commencement of pivotal phase 3 clinical studies of PBI-4050 in patients with Alström Syndrome.
Continuing to work with external advisors, Lazard, on opportunities to partner or monetize assets and businesses outside of the Company’s small molecule therapeutics business.
Initiation of Phase 1 clinical studies for PBI-4547.
Completing the process to list the Company’s common shares for trading on NASDAQ.

2019 Second Quarter Results

Revenues

Total revenues for the quarter ended June 30, 2019 were $8.8 million compared to $20.2 million during the comparative period of 2018 which represents a decrease of $11.4 million.

Revenues from the sale of goods were $8.4 million during the quarter ended June 30, 2019 compared to $19.7 million during the corresponding period of 2018, representing a decrease of $11.3 million. The decrease is due to the decrease in sales of excess normal source plasma inventory and was partially offset by increases in sales from our Bioseparation products by $2.3 million.

Cost of sales and other production expenses

Cost of sales and other production expenses were $3.9 million during the quarter ended June 30, 2019 compared to $16.4 million for the corresponding period in 2018, representing a decrease of $12.5 million. The decrease in cost of sales and other production expenses, is mainly driven by changes in the volume of sales of goods.

Research and Development ("R&D")

R&D expenses were $24.2 million during the quarter ended June 30, 2019 compared to $24.0 million for the corresponding period in 2018, representing a slight increase of $0.2 million.

R&D expenses include the cost to manufacture plasma-derived therapeutics and small molecule therapeutics for use in clinical trial studies, to supply clinical trial patients until commercially approved product is available, and the cost for the development of our production processes of Ryplazim in preparation of filing an amended BLA to the FDA. The manufacturing and purchase cost of these therapeutics was $11.8 million during the quarter ended June 30, 2019 compared to $10.9 million during the quarter ended June 30, 2018.

Administration, Sales & Marketing

Administration, selling and marketing expenses were $18.6 million during the quarter ended June 30, 2019 compared to $6.9 million for the corresponding period in 2018, representing an increase of $11.6 million. This increase is mainly attributable to the $9.4 million increase in share-based payments expense due to significant changes in stock options and restricted stock units driven by the Refinancing Transactions.

Share-based payments expense

Share-based payments expense represents the expense recorded as a result of stock options and restricted stock units issued to employees and directors.

Share-based payments expense were $14.9 million during the quarter ended June 30, 2019 compared to $0.7 million during the corresponding period of 2018, representing an increase of $14.2 million.

In conjunction with the Refinancing Transactions, the Company made significant changes to its long-term equity incentive plans to ensure alignment with performance and building shareholder value, and attraction and retention of key employees to drive the Company’s future growth. The following important changes were made:

the cancellation of the outstanding options for employees in return for the issuance of new options;
the modification of the outstanding performance-based restricted share units ("RSU") into time-vesting RSU, and discontinuation of the RSU plan for any future grants; and
the issuance of the new stock options to employees and directors with vesting consistent with industry norms and tied to long-term increases in shareholder value.
Certain of these changes triggered an immediate or accelerated recognition of share-based compensation expense during the quarter ended June 30, 2019, causing a substantial increase in the non-cash share-based compensation expense during the quarter.

Finance Costs

Finance costs were $3.6 million for the quarter ended June 30, 2019 compared to $5.3 million during the corresponding period of 2018, representing a decrease of $1.8 million. The decrease is mainly due to lower level of debt in the quarter ended June 30, 2019 compared to the same period of 2018 due to the debt restructuring completed as of April 23, 2019.

The adoption of the new lease standard, IFRS 16, Leases ("IFRS 16"), at the beginning of 2019, under which lease liabilities are recognized for the discounted value of the future lease payments at initial adoption and with interest expense recognized over the term of each lease, is contributing to increasing finance costs in 2019. The new standard was adopted using the modified retrospective approach and as such, the 2018 figures are not restated. Previously, the embedded interest component in each lease payment was recognized as part of the lease expense included in the various functions presented in the statement of operations such as cost of sales and other production expenses, R&D and administration, selling and marketing. The interest expense over the lease liabilities was $1.8 million and $3.6 million for the quarter and the six months ended June 30, 2019, respectively.

Non-cash loss on extinguishment of liabilities

Loss on extinguishments of liabilities were $92.3 million for the quarter ended June 30, 2019 principally as a result of the Company concluding a debt restructuring agreement on April 23, 2019 with its major creditor, SALP. The debt was reduced to $10.0 million plus accrued interest due, in exchange for the issuance of 15,050,312 post-consolidation Common Shares. The difference between the adjustment to the carrying value of the loan of $141.5 million and the amount recorded for the shares issued of $228.9 million was recorded as a loss on extinguishment of a loan of $87.4 million. This amount represents the immediate recognition of the accreted interest that would have otherwise been recognized as finance costs over the years until the maturity of the long-term debt. Legal fees related to the debt restructuring and the value of the Warrant Repricing were also recognized as part of the loss on extinguishment of liabilities.

Net Loss

The Company incurred a net loss of $133.7 million during the quarter ended June 30, 2019 compared to a net loss of $33.1 million for the corresponding period of 2018, representing an increase in the net loss of $94.9 million. This is mainly driven by the impact of the loss on extinguishment of liabilities caused by the debt restructuring of $92.3 million that occurred during the second quarter and the increase in the share-based compensation expense of $14.2 million.

Subsequent Events

On July 2, 2019, In anticipation of filing a listing application for trading the Company’s Common Shares on NASDAQ, Prometic announced the consolidation of the Company’s issued and outstanding common shares on the basis of one (1) post-consolidation Common Share for every one thousand (1000) pre-consolidation Common Shares (the "Consolidation"). This consolidation was approved at the special meeting of the common shareholders of the Company held on June 19, 2019 and commenced trading on the TSX on a post-consolidation basis at the open of trading on July 5, 2019.

NGM Bio Provides Pipeline Update and Reports Second Quarter 2019 Financial Results

On August 12, 2019 NGM Biopharmaceuticals, Inc. (Nasdaq: NGM), a clinical stage biotechnology company focused on developing transformative therapeutics for patients, reported second quarter 2019 financial results for the period ending June 30, 2019 (Press release, NGM Biopharmaceuticals, AUG 12, 2019, View Source [SID1234538637]).

"Our initiation of a Phase 1 clinical study of NGM621 to treat dry AMD demonstrates our continued progress in executing on our goal to operate one of the industry’s most productive R&D engines," said David J. Woodhouse, Ph.D., chief executive officer of NGM. "We have made important progress advancing NGM282 as a potential treatment for NASH, having advanced this program into Phase 2b clinical development earlier this year. With our R&D roots firmly established and continuing to grow in the metabolic and liver spaces, we are actively building a robust pipeline that also includes novel product candidates for additional therapeutic areas, including oncology and ophthalmic diseases. This strategy positions us to tackle a spectrum of significant unmet needs, leveraging fully our in-house biology and biologics expertise."

Second Quarter 2019 and Recent Highlights

Completed enrollment of Cohort 4 of the Phase 2 clinical study of NGM282 (aldafermin) in non-alcoholic steatohepatitis (NASH) patients with F2-F3 fibrosis. Cohort 4 has enrolled 78 patients with biopsy-confirmed NASH and stage F2-F3 liver fibrosis and will assess the efficacy, safety and tolerability of aldafermin 1 mg compared to placebo. An interim analysis of the non-invasive measures of efficacy, including liver fat content as measured by MRI-PDFF, liver transaminases and exploratory fibrosis biomarkers, will be conducted in approximately half the subjects after 24 weeks of treatment. NGM expects to report these interim data in the fourth quarter of 2019. Topline results of the full Cohort 4, which will include an assessment of the effect of 24 weeks of treatment on liver histology, are anticipated in early 2020. NGM plans to report preliminary results on ALPINE 2/3, an ongoing Phase 2b study of aldafermin in NASH patients with F2-F3 fibrosis, by the end of 2020.

Dosed first patient in Phase 1 clinical study of NGM621 for the treatment of geographic atrophy, an advanced form of dry AMD. NGM621 is an antibody binding an undisclosed target that has supportive human genetics data to suggest that inhibition of this pathway can effectively slow the progression of vision loss in patients with dry AMD. Currently, there are no approved therapies to treat dry AMD, a disease that is prevalent in approximately one million adults in the United States and progresses to permanent loss of central vision. The primary objective of the Phase 1 clinical study is to evaluate the safety, tolerability and pharmacokinetics of up to two intravitreal doses of NGM621 in patients with geographic atrophy.

Completed Phase 1 clinical study of NGM120. NGM is evaluating the potential of NGM120, an antagonistic antibody binding GFRAL, as a potential treatment of cancer anorexia-cachexia syndrome (CACS). The primary objective of the Phase 1 double blind, placebo-controlled single ascending dose and multiple ascending dose study was to evaluate the safety, tolerability and pharmacokinetics of NGM120 (single doses up to 400 mg and three monthly doses of up to 200 mg) in healthy adult subjects. Preliminary results demonstrate that NGM120 was well-tolerated at all doses studied and the pharmacokinetics support once-monthly dosing. Later this year, NGM plans to initiate a Phase 1a/1b clinical study to further evaluate the safety, tolerability and pharmacokinetics of NGM120, and to gather preliminary evidence of anti-cancer and anti-CACS activity in patients with select solid tumors, including pancreatic cancer.

Second Quarter Financial Results

Related party revenue for the second quarter of 2019 was $25.3 million, compared to $22.1 million for the same period in 2018.

Research and development expenses for the second quarter of 2019 were $28.8 million, compared to $22.8 million for the same period in 2018. The increase in research and development expenses was primarily attributable to increases in unallocated research and development expenses associated with personnel-related expenses, external research and development expenses associated with the advancement of NGM’s growing pipeline and aldafermin program expenses due to ongoing Phase 2 and Phase 2b clinical trials.

General and administrative expenses for the second quarter 2019 were $6.2 million, compared to $3.5 million for the same period in 2018. The increase in general and administrative expenses was primarily attributable to personnel-related expenses and an increase in legal and professional service expenses required to support NGM’s ongoing operations as a public company.

For the second quarter of 2019, NGM reported a net loss of $7.7 million, compared to a net loss of $3.2 million for the same period in 2018.

Cash, cash equivalents and short-term marketable securities were $362.2 million as of June 30, 2019, compared to $206.6 million as of December 31, 2018. The increase of $155.6 million was primarily attributable to net cash proceeds of $173.7 million from the Company’s initial public offering and concurrent private placement offset by cash used in operations over the period.