On August 10, 2020 Allakos Inc. (the "Company") (Nasdaq: ALLK), a biotechnology company developing AK002 for the treatment of eosinophil and mast cell-related diseases, reported financial results for the second quarter ended June 30, 2020 and provided an update of its ongoing development activities (Press release, Allakos, AUG 10, 2020, View Source [SID1234563285]).

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Business Updates

Patient enrollment was initiated in a randomized, double-blind, placebo-controlled Phase 3 study of AK002 in patients with eosinophilic gastritis (EG) and/or eosinophilic duodenitis (EoD). Topline data are expected in the second half of 2021.

Patient enrollment was initiated in a randomized, double-blind, placebo-controlled Phase 2/3 study of AK002 in patients with eosinophilic esophagitis (EoE). Topline data are expected in the second half of 2021.

The Phase 1 safety, tolerability and pharmacokinetics study of the subcutaneous formulation of AK002 is fully enrolled. Results are expected in the second half of 2020.

The non-interventional study examining the prevalence of EG, EoD, and mast cell gastrointestinal disease (MGID) in patients with chronic functional gastrointestinal disease is fully enrolled. Results are expected in the second half of 2020.

Announced positive clinical safety and efficacy results from a six-month, open-label Phase 1 study of AK002 in patients with MGID in March 2020.

Announced positive interim safety and efficacy results from the open-label, long-term extension component of the ENIGMA study with AK002 in patients with EG and/or EoD. The results were accepted for oral presentation and presented virtually at the Digestive Disease Week (DDW) Annual Meeting in May 2020.

The nonproprietary (generic) name of AK002 was changed from antolimab to lirentelimab as a result of trademark issues identified outside of the United States. Lirentelimab has been adopted by the United States Adopted Names (USAN) Council and World Health Organization (WHO) International Nonproprietary Names (INN) Program.

Second Quarter 2020 Financial Results

Research and development expenses were $28.3 million in the second quarter of 2020 as compared to $14.1 million in the same period in 2019, an increase of $14.2 million.

General and administrative expenses were $12.1 million in the second quarter of 2020 as compared to $5.9 million in the same period in 2019, an increase of $6.2 million.

Allakos reported a net loss of $39.3 million in the second quarter of 2020 as compared to $19.1 million in the same period in 2019, an increase of $20.2 million. Net loss per basic and diluted share was $0.80 for the second quarter of 2020 compared to $0.44 in the same period in 2019.

Allakos ended the second quarter of 2020 with $454.9 million in cash, cash equivalents and marketable securities.

On August 10, 2020 Momenta Pharmaceuticals, Inc. (Nasdaq: MNTA), a biotechnology company focused on discovering and developing novel biologic therapeutics to treat rare immune-mediated diseases, reported its financial results for the second quarter ended June 30, 2020 (Press release, Momenta Pharmaceuticals, AUG 10, 2020, View Source [SID1234563284]).

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"Momenta has made meaningful progress advancing our novel drug portfolio for auto- and alloimmune diseases, including a substantial data update from our lead program, nipocalimab," said Craig A. Wheeler, President and Chief Executive Officer of Momenta Pharmaceuticals. "In particular, we achieved proof of concept for nipocalimab, establishing a linear and highly statistically significant correlation between rapid and durable IgG reduction and efficacy in MG. We are preparing to engage with regulators on the design for a Phase 3 study in MG and look forward to reporting full results from Vivacity-MG in the fourth quarter of 2020, as we advance ongoing studies of nipocalimab in other indications.

Additionally, we were very pleased to receive rare pediatric disease designation for nipocalimab in hemolytic disease of the fetus and newborn (HDFN), which emphasizes the need for non-invasive, safe and effective treatment options for pregnant women with alloimmune diseases. Importantly, our data and FDA’s action supports nipocalimab as a best-in-class investigational FcRn-inhibitor for dosing precision and flexibility and its utility across IgG-mediated diseases.

Lastly, with M254, we recently completed enrollment in Part B of our multi-part Phase 1/2 clinical trial in idiopathic thrombocytopenic purpura (ITP) and look forward to sharing the study results later this quarter."

Second Quarter 2020 Highlights, Recent Events and Anticipated Upcoming Milestones

Novel Therapeutics Pipeline:

Nipocalimab (M281): a fully human anti-neonatal Fc receptor (FcRn) aglycosylated immunoglobulin G (IgG1) monoclonal antibody (mAb) candidate

·In June 2020, Momenta announced positive topline data from an interim analysis of Vivacity-MG, the Company’s Phase 2 study of nipocalimab in generalized myasthenia gravis (gMG). The results demonstrated that nipocalimab induced a rapid and durable response in the myasthenia gravis activities of daily living score (MG-ADL) at all doses and met the study’s primary efficacy endpoint, demonstrating a linear and highly statistically significant (p<0.0001) relationship between Immunoglobulin G (IgG) reduction and MG-ADL clinical benefit. Nipocalimab was also observed to be well-tolerated, with no adverse events leading to discontinuation. The study is expected to be completed in the third quarter of 2020, and the Company plans to present the full 16-week data in the fourth quarter of 2020. Additionally, Momenta has begun preparations to conduct an end of Phase 2 meeting with the U.S. Food and Drug Administration (FDA) before the end of 2020 and anticipates initiating a Phase 3 study in the first quarter of 2021.
·Unity, Momenta’s global multi-center Phase 2 clinical study of nipocalimab in hemolytic disease of the fetus and newborn (HDFN), continues to enroll patients at sites where they can be safely accommodated. FDA recently granted Rare Pediatric Disease Designation and Orphan Drug Designation for nipocalimab in HDFN.
·Momenta continues to activate sites globally for the Energy Study, the Company’s adaptive Phase 2/3 clinical study of nipocalimab in warm autoimmune hemolytic anemia (wAIHA). Patient enrollment was temporarily suspended due to the COVID-19 pandemic but is expected to resume in the fourth quarter 2020. Momenta has amended the study protocol to facilitate remote monitoring procedures.

M254 (hsIgG): a hypersialylated immunoglobulin candidate designed as a high potency alternative for intravenous immunoglobulin (IVIg)

·Patient enrollment is complete in Part B of the Company’s Phase 1 / 2 study in idiopathic thrombocytopenic purpura (ITP), which is evaluating M254 in a single ascending dose cohort of ITP patients, followed by 1,000 mg/kg of IVIg. The Company intends to release results from this study in the third quarter of 2020 and has initiated patient enrollment in Part Cof the study.
·The Company’s planned Phase 2 study of M254 in chronic inflammatory demyelinating polyneuropathy (CIDP) is expected to initiate in 2021.

M230 (CSL730): a recombinant Fc multimer candidate being developed in collaboration with CSL

·Momenta’s collaboration partner, CSL, plans to introduce a subcutaneous formulation into the Phase 1 program later this year.

M267: a SIFbody candidate targeting CD38, designed to combine multiple Fc’s with antibody fabs to optimally activate Fc, complement effector function and effectively deplete target cells.

·IND-enabling studies are ongoing, and the Company expects to submit an IND for M267 in 2021.

Necuparanib (M402): The Company is currently exploring the utility of necuparanib (M402), a former novel oncology candidate, as a potential therapy for treating COVID-19. The Company has confirmed the ability of necuparanib (M402) to bind to the SARS-Cov2 spike protein and is assessing the potential to block viral infection of respiratory epithelial cells. As multiple respiratory viruses are believed to utilize binding to heparin sulfate glycoproteins on cells to facilitate infection, the Company is assessing the ability of necuparanib to block cell infection by other coronavirus and respiratory viruses. The Company anticipates completing the initial cell infection studies in the coming weeks.

Legacy Products:

GLATOPA 20 mg and 40 mg: U.S. Food and Drug Administration (FDA) approved generic versions of COPAXONE 20 mg and 40 mg, developed and commercialized in collaboration with Sandoz

·In the second quarter of 2020, Momenta recorded $6.6 million in product revenue from Sandoz’s sales of GLATOPA products.

M710: a proposed biosimilar to EYLEA (aflibercept) candidate being developed in collaboration with Mylan

·Mylan continues its pivotal clinical trial in patients with diabetic macular edema to compare safety, efficacy and immunogenicity of M710 with EYLEA. Mylan expects to target U.S. submission in 2021, while monitoring and navigating potential COVID-19 issues.

Second Quarter 2020 Financial Results

Revenue:

In the second quarter of 2020, the Company recorded $6.6 million in product revenue from Sandoz’s sales of GLATOPA, compared to $3.3 million for the same period in 2019. The increase in product revenue from the prior year period was primarily due to higher net sales of GLATOPA, driven by volume increases.

Research and development revenue for the second quarter of 2020 was less than $0.1 million, compared to $1.8 million for the same period in 2019. The decrease in research and development revenue of $1.8 million, or 99%, was primarily due to lower reimbursement revenue for GLATOPA expenses and lower revenue recognized from Mylan’s upfront payment associated with the biosimilar collaboration.

Total revenue for the second quarter of 2020 was $6.6 million compared to $5.2 million for the same period in 2019.

Operating Expenses:

Research and development expenses for the second quarter of 2020 were $38.8 million, compared to $32.1 million for the same period in 2019. The increase of $6.7 million, or 21%, was primarily due to an increase in manufacturing and clinical trial costs for nipocalimab and M254 and an increase in share-based compensation expense, offset in part by lower lease costs.

General and administrative expenses for the second quarter of 2020 were $25.3 million, compared with $46.6 million for the same period in 2019. The decrease of $21.3 million, or 46%, was primarily due to a payment of $21.0 million in June 2019 reflecting the Company’s portion of a settlement payment; lower legal fees and lower depreciation and rent costs due to the modification to the Bent Street lease in 2019; partially offset by an increase in share-based compensation expense.

Other operating expenses in the second quarter of 2019 included a $42.9 million charge to be paid between the end of 2020 and 2022, related to Momenta’s manufacturing agreement with GSK, the supplier of M923. Following the Company’s decision to cease development activity relating to M923, Momenta incurred these charges for canceled manufacturing runs scheduled through 2020 and may not use manufacturing runs scheduled for 2021 and 2022.

Total GAAP operating expenses were $64.0 million in the second quarter of 2020. Second quarter 2020 non-GAAP operating expense was $44.6 million. Non-GAAP operating expense is total operating expenses, less stock-based compensation expense, restructuring expense and collaborative reimbursement revenue. See "Non-GAAP Financial Information and Other Disclosures" and the table below entitled "Reconciliation of GAAP Results to Non-GAAP Financial Measures" for a reconciliation of GAAP operating expense to non-GAAP operating expense.

Net Loss:

The Company reported a net loss of $57.0 million, or $0.48 per share for the second quarter of 2020 compared to a net loss of $114.0 million, or $1.16 per share for the same period in 2019.

Liquidity:

At June 30, 2020, Momenta had $450.6 million in cash, cash equivalents, and marketable securities. This compares to $545.1 million at December 31, 2019 in cash, cash equivalents, and marketable securities.

2020 Financial Guidance

Momenta provides non-GAAP operating expense guidance, which it believes can enhance an overall understanding of its financial performance when considered together with GAAP financial measures. Refer to the section of this press release below entitled "Non-GAAP Financial Information and Other Disclosures" for further discussion of this subject.

Non-GAAP operating expense is total operating expenses, less stock-based compensation expense, restructuring expense and collaborative reimbursement revenues. Due to lower clinical trial enrollment trends as a result of the COVID-19 pandemic, Momenta anticipates its full-year non-GAAP operating expenses will be in the range of $200 to $220 million.

Non-GAAP Financial Information and Other Disclosures

Momenta uses a non-GAAP financial measure, non-GAAP operating expense, to provide operating expense guidance. Momenta believes this non-GAAP financial measure is useful to investors because it provides greater transparency regarding Momenta’s operating performance as it excludes non-cash stock compensation expense, restructuring expense and collaborative reimbursement revenue. This non-GAAP financial measure should not be considered a substitute or an alternative to GAAP total operating expense and should not be considered a measure of Momenta’s liquidity. Instead, non-GAAP operating expense should only be used to supplement an understanding of Momenta’s operating results as reported under GAAP. Momenta has not provided GAAP reconciliation for its forward-looking non-GAAP annual or quarterly operating expense because Momenta cannot reliably predict without unreasonable efforts the timing or amount of the factors that substantially contribute to the projection of stock compensation expense, which is excluded from the forward-looking non-GAAP financial measure. The Company does not expect restructuring expense and collaboration reimbursement revenue to be material.

Conference Call Information

Management will host a conference call and webcast today at 8:30 am ET to discuss these results and provide an update on the Company. A live webcast of the conference call may be accessed on the "Investors" section of the Company’s website, www.momentapharma.com. Please go to the site at least 15 minutes prior to the call in order to register, download, and install any necessary software. An archived version of the webcast will be posted on the Momenta website approximately two hours after the call.

To access the call, you may also dial (888) 349-0106 (domestic) or (412) 902-0131 (international) prior to the scheduled conference call time and provide the access code 9178486.

On August 10, 2020 Radius Health, Inc. ("Radius" or the "Company") (Nasdaq: RDUS), reported its financial and operating results for the second quarter ended June 30, 2020 and provided a business update (Press release, Radius, AUG 10, 2020, View Source [SID1234563283]).

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"Completing the elacestrant transaction was an important step forward for the company, centering our clinical and regulatory strategy while strengthening ourselves from a financial perspective," said Kelly Martin, CEO of Radius Health. Martin commented further that "in the near-term, our focus will include completing our Phase 3 pivotal trial enrollments while adjusting our commercial and marketing efforts to focus on high-risk osteoporosis patients."

Business Update

Commercial

Second quarter 2020 U.S. net sales of TYMLOS were $50.1 million, a 22% increase over the second quarter of 2019.

Business Development

In July, Radius entered into an exclusive global license agreement for development and commercialization of elacestrant with Menarini Group. Under the agreement, Menarini Group will be responsible for worldwide commercialization of elacestrant, after the completion of EMERALD Phase 3 study and, assuming positive results, successful registration of elacestrant.

Radius will continue to be responsible for the conduct and completion of the Phase 3 EMERALD study through NDA filing. The Company expects over $100 million of expenses associated with this activity will be reimbursed by Menarini.

As part of the agreement, Radius received an upfront payment of $30 million, and is eligible to receive up to $20 million on the achievement of certain development and regulatory milestones and up to $300 million on the achievement of certain sales milestones. Menarini Group will make tiered, low to mid-teen percentage royalty payments to Radius Health on global net sales.

Clinical Development Update

Abaloparatide-patch

The wearABLe Phase 3 study with abaloparatide-patch in postmenopausal osteoporosis continues to advance its enrollment globally. Completion of enrollment remains on track for the later part of third quarter of 2020.

Abaloparatide-SC

The ATOM Phase 3 Study, which is assessing the efficacy and safety of abaloparatide-SC in men with osteoporosis, is expected to complete recruitment this week with the enrollment of one more patient.

Teijin Pharma Limited, Radius’ partner for abaloparatide-SC in Japan, submitted a New Drug Application for abaloparatide-SC in Japan for the treatment of osteoporosis in patients who are at high risk for fractures, based on the positive results of their Phase III study. The study achieved its efficacy endpoint and showed an acceptable safety profile. Detailed results of this trial are planned to be presented at a global medical conference in the second half of this year.

Elacestrant

The EMERALD Phase 3 study is on schedule to complete target recruitment in the fourth quarter of 2020.

Second Quarter 2020 Financial Results

Three Months Ended June 30, 2020

For the three months ended June 30, 2020, Radius reported a net loss of $43.9 million, or $0.95 per share, compared to a net loss of $35.5 million, or $0.77 per share, for the three months ended June 30, 2019.

For the three months ended June 30, 2020, non-GAAP adjusted net loss, which excludes expenses related to stock-based compensation, restructuring plans, depreciation, non-cash interest obligations under debt obligations, impairment of operating lease right of use assets, and amortization of intangible assets, was $31.2 million, or $0.67 per share, compared to non-GAAP adjusted net loss of $25.4 million, or $0.55 per share, for the three months ended June 30, 2019.

For the three months ended June 30, 2020, TYMLOS net product revenues were $50.1 million compared to approximately $41.0 million for the three months ended June 30, 2019.

For the three months ended June 30, 2020, research and development expense was $44.9 million compared to $27.2 million for the three months ended June 30, 2019, an increase of $17.7 million, or 65%. This increase was primarily driven by a $13.9 million increase in abaloparatide-patch program costs, a $5.2 million increase in elacestrant program costs, a $0.2 million increase in abaloparatide-SC program costs, and a $0.2 million increase in compensation expenses. These increases were offset by a decrease of $0.8 million in RAD140 program cost, a $0.4 million decrease in occupancy and depreciation, a $0.4 million decrease in travel and entertainment expense, a $0.1 million decrease in professional fees, and a $0.1 million decrease in other operating costs.

For the three months ended June 30, 2020, selling, general and administrative expense was $38.2 million compared to $40.1 million for the three months ended June 30, 2019, a decrease of $1.9 million, or 5%. This decrease was primarily the result of a $2.0 million decrease in travel and entertainment expenses, a $1.1 million decrease in professional support costs, a $0.3 million decrease in occupancy and depreciation costs, and a $0.3 million decrease in other operating costs. These decreases were partially offset by a $1.8 million increase in compensation costs.

Six Months Ended June 30, 2020

For the six months ended June 30, 2020, Radius reported a net loss of $81.5 million, or $1.76 per share, compared to a net loss of $78.2 million, or $1.70 per share, for the six months ended June 30, 2019.

For the six months ended June 30, 2020, non-GAAP adjusted net loss, which excludes expenses related to stock-based compensation, restructuring plans, depreciation, non-cash interest obligations under debt obligations, impairment of operating lease right of use assets, and amortization of intangible assets, was $58.6 million, or $1.26 per share, compared to non-GAAP adjusted net loss of $57.2 million, or $1.25 per share, for the six months ended June 30, 2019.

For the six months ended June 30, 2020, TYMLOS net product revenues were $98.0 million compared to approximately $70.9 million for the six months ended June 30, 2019.

For the six months ended June 30, 2020, research and development expense was $83.9 million compared to $50.4 million for the six months ended June 30, 2019, an increase of $33.5 million, or 66%. This increase was primarily driven by a $25.0 million increase in abaloparatide-patch project costs, a $8.7 million increase in project costs for elacestrant, a $0.6 million increase in abaloparatide-SC project costs, a $0.8 million increase in professional fees services, and a $0.4 million increase in compensation expenses. These increases were partially offset by a $1.0 million decrease in RAD140 project costs, a $0.3 million decrease in occupancy and depreciation costs, and a $0.7 million decrease in travel and entertainment expenses.

For the six months ended June 30, 2020, selling, general and administrative expense was $74.7 million compared to $81.3 million for the six months ended June 30, 2019, a decrease of $6.6 million, or 8%. This decrease was primarily the result of a $4.0 million decrease in professional fees, a $2.5 million decrease in travel and entertainment expenses, a $0.8 million decrease in occupancy and depreciation costs and a $0.2 million decrease in other operating expense. These decreases were offset by a $0.8 million increase in compensation related expenses.

As of June 30, 2020, Radius had $126.3 million in cash, cash equivalents, restricted cash, and marketable securities. Based upon our cash, cash equivalents and marketable securities balance as of June 30, 2020, we believe that, prior to the consideration of potential proceeds from partnering and/or collaboration activities, we have sufficient capital to fund our development plans, U.S. commercial and other operational activities for at least twelve months from the date of this press release.

Webcast and Conference Call

In connection with today’s reporting of Second Quarter 2020 Financial Results, Radius will host a conference call and live audio webcast at 8:30 a.m. ET today, August 10, 2020, to review the commercial, research and development, and financial highlights and provide a Company update.

Conference Call Information:

Date: August 10, 2020

Time: 8:30 a.m. ET

Domestic Dial-in Number: (866) 323-7965

International Dial-in Number: (346) 406-0961

Conference ID: 6334188

Live webcast: View Source

A live audio webcast of the call can be accessed from the Investors section of the Company’s website, www.radiuspharm.com. The full text of the announcement and financial results will also be available on the Company’s website.

For those unable to participate in the conference call or webcast, a replay will be available on Thursday, August 10, 2020 at 11:30 a.m. ET and will be archived on the Company’s website for 90 days. To access the replay, dial (855) 859-2056 for U.S. or (404) 537-3406 for International, using conference ID number 6334188.

On August 10, 2020 Allakos Inc. (the "Company") (Nasdaq: ALLK), a biotechnology company developing AK002 for the treatment of eosinophil and mast cell-related diseases, reported financial results for the second quarter ended June 30, 2020 and provided an update of its ongoing development activities (Press release, Allakos, AUG 10, 2020, View Source [SID1234563282]).

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Business Updates

Patient enrollment was initiated in a randomized, double-blind, placebo-controlled Phase 3 study of AK002 in patients with eosinophilic gastritis (EG) and/or eosinophilic duodenitis (EoD). Topline data are expected in the second half of 2021.

Patient enrollment was initiated in a randomized, double-blind, placebo-controlled Phase 2/3 study of AK002 in patients with eosinophilic esophagitis (EoE). Topline data are expected in the second half of 2021.

The Phase 1 safety, tolerability and pharmacokinetics study of the subcutaneous formulation of AK002 is fully enrolled. Results are expected in the second half of 2020.

The non-interventional study examining the prevalence of EG, EoD, and mast cell gastrointestinal disease (MGID) in patients with chronic functional gastrointestinal disease is fully enrolled. Results are expected in the second half of 2020.

Announced positive clinical safety and efficacy results from a six-month, open-label Phase 1 study of AK002 in patients with MGID in March 2020.

Announced positive interim safety and efficacy results from the open-label, long-term extension component of the ENIGMA study with AK002 in patients with EG and/or EoD. The results were accepted for oral presentation and presented virtually at the Digestive Disease Week (DDW) Annual Meeting in May 2020.

The nonproprietary (generic) name of AK002 was changed from antolimab to lirentelimab as a result of trademark issues identified outside of the United States. Lirentelimab has been adopted by the United States Adopted Names (USAN) Council and World Health Organization (WHO) International Nonproprietary Names (INN) Program.
Second Quarter 2020 Financial Results

Research and development expenses were $28.3 million in the second quarter of 2020 as compared to $14.1 million in the same period in 2019, an increase of $14.2 million.

General and administrative expenses were $12.1 million in the second quarter of 2020 as compared to $5.9 million in the same period in 2019, an increase of $6.2 million.

Allakos reported a net loss of $39.3 million in the second quarter of 2020 as compared to $19.1 million in the same period in 2019, an increase of $20.2 million. Net loss per basic and diluted share was $0.80 for the second quarter of 2020 compared to $0.44 in the same period in 2019.

Allakos ended the second quarter of 2020 with $454.9 million in cash, cash equivalents and marketable securities.

On August 10, 2020 Galectin Therapeutics Inc. (NASDAQ: GALT), the leading developer of therapeutics that target galectin proteins, reported financial results and provided a business update for the quarter ended June 30, 2020 (Press release, Galectin Therapeutics, AUG 10, 2020, View Source [SID1234563281]). These results are included in the Company’s Quarterly Report on Form 10-Q, which has been filed with the U.S. Securities and Exchange Commission and is available at www.sec.gov.

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Harold H. Shlevin, Ph.D., President and Chief Executive Officer of Galectin Therapeutics, said, "We are excited to have initiated the NASH-RX trial, having enrolled our first patient in June and continuing to enroll patients at several of our sites in our clinical trial of belapectin targeting cirrhotic NASH patients. If the results of the NASH-RX trial are compelling, there could be the potential for accelerated FDA approval and/or partnership opportunity with a pharmaceutical company. Later this quarter, we plan to host a conference call with the Investment Community for a more thorough discussion of the NASH-RX trial, its current status, our updated strategy, and to take questions."

Richard E. Uihlein, Chairman of the Board, added, "The protocol of the NASH-RX trial has been designed to provide belapectin with the best chance to demonstrate efficacy and safety, and I am very pleased this trial is now underway. Belapectin is targeting NASH cirrhosis patients, those who can no longer expect to benefit from increased exercise or an improved diet as may benefit many of those with earlier stages of NASH. And, belapectin (formerly known as GR-MD-02) is the first drug that has been shown to prevent the development of esophageal varices in patients with compensated NASH cirrhosis. If confirmed, these results would constitute a significant benefit for patients. Consequently, we believe our drug targets NASH at a very critical point of its development, as it represents an opportunity to prevent the progression of liver damage, and thereby save lives."

The NASH-RX trial will use an adaptive design to confirm dose selection and reaffirm the efficacy data observed in the NASH-CX trial and, with pre-planned adaptations, inform the larger Phase 3 trial component. In June 2020, we enrolled our first patients in the NASH-RX trial. NASH-RX is expected to enroll approximately 315 NASH patients in the Phase 2b part of the trial at approximately 130 sites in 12 countries in North America, Europe, Asia and Australia.

Galectin plans to host a conference call with the investment community in the third quarter to provide a more comprehensive description and update on the status of the trial and to take questions. The date and time of the call and how to participate will be published in advance of the planned call.

Financial Results

For the three months ended June 30, 2020, the Company reported a net loss applicable to common stockholders of $6.2 million, or ($0.11) per share, compared to a net loss applicable to common stockholders of $3.1 million, or ($0.06) per share for the three months ended June 30, 2019. The increase is due to 2020 research and development expense related to the Company’s NASH-RX trial.

Research and development expense for the three months ended June 30, 2020 was $4.7 million compared with $1.5 million for the three months ended June 30, 2019. The increase was primarily due to costs related to our NASH-RX clinical trial, along with preparations and some preclinical activities incurred in support of the clinical program, such as development and reproductive toxicity studies, clinical supplies and other supportive activities. General and administrative expenses for the three months ended June 30, 2020, were $1.4 million, down from $1.5 million for the three months ended March 31, 2019, primarily due to a decrease in stock-based compensation expenses.

As of June 30, 2020, the Company had $40.8 million of cash and cash equivalents. The Company also has a $10 million unsecured line of credit, under which no borrowings have been made to date. The Company believes it has sufficient cash, including availability under the line of credit, to fund currently planned operations and research and development activities through at least September 30, 2021.

The Company expects that it will require more cash to fund operations after September 30, 2021 and believes it will be able to obtain additional financing as needed. The total cost to obtain the interim analysis data of the planned trial, including general overhead, is currently estimated to be approximately $90 million. These costs will require additional funding. There can be no assurance that we will be successful in obtaining financing to support our operations beyond September 30, 2021, or, if available, that any such financing will be on terms acceptable to us.

About Belapectin (GR-MD-02)

Belapectin (GR-MD-02) is a complex carbohydrate drug that targets galectin-3, a critical protein in the pathogenesis of fatty liver disease and fibrosis. Galectin-3 plays a major role in diseases that involve scarring of organs including fibrotic disorders of the liver, lung, kidney, heart and vascular system. The drug binds to galectin proteins and disrupts their function. Preclinical data in animals have shown that belapectin has robust treatment effects in reversing liver fibrosis and cirrhosis.

About Fatty Liver Disease with Advanced Fibrosis and Cirrhosis

Non-alcoholic steatohepatitis (NASH) has become a common disease of the liver with the rise in obesity and other metabolic diseases. NASH is estimated to affect up to 28 million people in the U.S. It is characterized by the presence of excess fat in the liver along with inflammation and hepatocyte damage (ballooning) in people who consume little or no alcohol. Over time, patients with NASH can develop excessive fibrosis, or scarring of the liver, and ultimately liver cirrhosis. It is estimated that as many as 1 to 2 million individuals in the U.S. will develop cirrhosis as a result of NASH, for which liver transplantation is the only curative treatment available. Approximately 8,890 liver transplants are performed annually in the U.S. There are no drug therapies approved for the treatment of liver fibrosis or cirrhosis.