On November 9, 2020 HUYA Bioscience International (HUYABIOTM), the leader in accelerating global development of China’s pharmaceutical innovations, reported the presentation of results from an ongoing Phase II study evaluating the efficacy and safety of HBI-8000 in combination with nivolumab in patients with advanced metastatic melanoma (Press release, HUYA Bioscience, NOV 9, 2020, View Source [SID1234570508]). The results were presented at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s virtual 35th Anniversary Annual Meeting (SITC 2020; Abstract # 797).

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"Data from this combination study are very encouraging," said lead investigator, Nikhil I. Khushalani, MD, Vice Chair and Senior Member of the Department of Cutaneous Oncology at Moffitt Cancer Center in Tampa, Florida. "As standard of care, patients with metastatic melanoma are routinely treated with a PD-1 inhibitor such as nivolumab or pembrolizumab.

When nivolumab was combined with HBI-8000, it appears the efficacy was enhanced while safety profile remains quite acceptable. The patients on the study are being followed for long- term outcomes. A Phase III study to further investigate the efficacy and safety of this combination of therapy is now planned."

Dr. Mireille Gillings, CEO & Executive Chair of HUYABIO, said, "These data further demonstrate the promise of HBI-8000 in cancer therapy. This builds on the momentum from our October 2020 regulatory submission to the Japanese Pharmaceuticals and Medical Devices Agency for HBI-8000 monotherapy for relapsed or refractory (R/R) adult T-cell leukemia/lymphoma (ATL)."

In a Phase Ib/II trial in patients with melanoma, renal and non-small cell lung cancer, the recommended Phase II dose of HBI-8000 was 30 mg orally twice weekly combined with nivolumab administered at the approved dosing schedule. The SITC (Free SITC Whitepaper) 2020 presentation described the safety profile of this combination in melanoma patients and showed signs of clinical benefit relative to historic controls who were receiving nivolumab for the first time.

Forty-nine patients (32 anti-PD1 naïve, 17 with prior anti-PD1 therapy) were treated with HBI- 8000 in combination with nivolumab. The median age was 63 years (range 28-84). The most common all grade treatment related adverse events (AEs) were fatigue (n=25), diarrhea (n=24), abdominal pain (n=14), and lymphopenia (n=13). Although HBI-8000 related thrombocytopenia (n=25) and neutropenia (n=15) were common, clinically significant bleeding or febrile neutropenia were not seen. Twelve patients discontinued treatment due to AEs. Among 31 anti- PD1 naïve patients evaluable for response, there were 23 objective responses (74%), five with stable disease (disease control rate 90%), and three with progressive disease. Median time to response was 1.9 months. At a median follow-up for this cohort of 8.9 months (range, 0.9-35.5 months), the median duration of response and median progression-free survival had not yet been reached.

About HBI-8000
HBI-8000 is an epigenetic immunomodulator approved for the treatment of lymphoma and metastatic breast cancer in China. This oral agent targets class I histone deacetylase causing cell cycle arrest and tumor cell death as the mechanism underlying its single agent activity against lymphoma. The drug also is immunomodulatory, increasing the efficacy of checkpoint inhibitors in preclinical animal models through its role in sustaining acetylation and nuclear transport of PD-L1.

On November 9, 2020 I-Mab (the "Company") (Nasdaq: IMAB), a clinical stage biopharmaceutical company committed to the discovery, development and commercialization of novel biologics, reported initial results from its U.S. phase 1 clinical trial (NCT03934814) evaluating lemzoparlimab (also known as TJC4) for the treatment of relapsed or refractory solid tumors and lymphoma (Press release, I-Mab Biopharma, NOV 9, 2020, View Source [SID1234570497]). The results were released in a poster entitled "A first-in-patient study of lemzoparlimab, a differentiated anti-CD47 antibody, in subjects with relapsed/refractory malignancy: initial monotherapy results" at the 2020 Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting, on November 9, 2020 (Abstract #385).

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Lemzoparlimab is a unique CD47 antibody that exerts strong anti-tumor activity while exhibiting a minimal binding to red blood cells. It is designed to avoid severe anemia — a common toxicity of CD47 antibodies of the same class.

"Lemzoparlimab was originally discovered and developed by I-Mab as a globally competitive CD47 antibody and has been uniquely designed to overcome the toxicity associated with this drug target," said Jingwu Zang, M.D., Ph.D., Founder, Honorary Chairman and Director of I-Mab. "The initial clinical results are consistent with the key differentiation of lemzoparlimab in terms of drug safety and the PK profile. These clinical advantages put lemzoparlimab in a highly competitive position among CD47 antibodies of the same class."

The phase 1 study is an open-label, multi-center, multiple dose study conducted in two parts. The first part is comprised of a single agent dose escalation followed by two separate combination regimens in an escalating dose range (Part 1b with pembrolizumab; Part 1c with rituximab). The second part is a dose expansion study in the combination therapies.

The data to be presented at SITC (Free SITC Whitepaper) include the initial results from the single agent therapy (N=20), which is designed to determine the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and anti-tumor activity of lemzoparlimab. The key findings include:

Lemzoparlimab was well tolerated up to 30 mg/kg on a weekly basis without priming dosing strategy. No dose-limiting toxicity and no clinical or laboratory evidence of hemolytic anemia were observed throughout.

Lemzoparlimab PK appears to be linear at mid to high dose levels following a single dose with no significant "sink effect".

One confirmed Partial Response (PR) was observed in the 30 mg/kg monotherapy cohort (N=3). The patient had failed prior treatments with checkpoint inhibitors.

"We are very encouraged by the safety and tolerability data that have emerged from the phase 1 trial," said Jordan Berlin, M.D. from Vanderbilt University, the principal investigator of the trial. "It shows the promise of lemzoparlimab as a differentiated CD47 antibody for multiple cancers, and we look forward to advancing the development of lemzoparlimab for patients with advanced solid tumors and hematologic malignancies." Dr. Berlin will present the data during the virtual poster sessions on November 11, 2020 5:15-5:45 p.m. EST and November 13, 2020 4:40-5:10 p.m. EST.

Recruitment of patients for the dose escalation study of lemzoparlimab in combination with pembrolizumab or rituximab is ongoing. Additional information on the clinical trial (NCT03934814) is available on www.clinicaltrials.gov.

In September 2020, I-Mab and AbbVie entered into a global strategic partnership to develop and commercialize lemzoparlimab. Subject to pre-closing conditions, both companies will be collaborating to further advance the clinical development of lemzoparlimab for the treatment of multiple cancers globally and in China.

I-Mab Conference Call and Webcast Information

Investors and analysts are invited to join the conference call today at 8:30 a.m. ET using the following dial-in information:

A live webcast and an archived replay of the conference call can be accessed on the Company’s investor relations website at View Source

A telephone replay will be available approximately two hours after the conclusion of the call by dialing +1-877-344-7529 (U.S.), 1-412-317-0088 (International). The conference ID number for the replay is 10149942. The replay will be available through November 16, 2020.

About CD47 and Lemzoparlimab

CD47 is a cell surface protein over-expressed in a wide variety of cancers and can act to protect tumors by delivering a "don’t eat me" signal to otherwise tumor-engulfing macrophages. CD47 antibody blocks this signal and enables macrophages to attack tumor cells, making it a potentially promising cancer drug. However, development of CD47 antibody as a cancer therapy is hampered by its hematologic side effects, such as severe anemia, caused by natural binding of CD47 antibody to red blood cells. In a scientific breakthrough, scientists at I-Mab have discovered a unique CD47 antibody, lemzoparlimab, that works efficiently to target tumor cells while exerting minimal untoward effect on red blood cells, thus avoiding severe anemia.

Lemzoparlimab’s hematologic safety advantage and superb anti-tumor activities have been demonstrated previously in a series of robust pre-clinical studies. The results of the phase 1 clinical trial have provided further, clinical validation of this differentiation in patients with cancer. I-Mab continues to advance a combination study of lemzoparlimab with Keytruda for the treatment of solid tumors and with Rituxan for the treatment of patients with lymphoma in the U.S., in addition to an ongoing clinical trial with patients with AML/MDS in China.

In September 2020, I-Mab and AbbVie entered into a global strategic partnership to develop and commercialize lemzoparlimab, including to design and conduct further clinical trials to evaluate lemzoparlimab in multiple cancers globally and in China. The collaboration is subject to certain pre-closing conditions.

On November 9, 2020 Morphic Therapeutic (Nasdaq: MORF), a biopharmaceutical company developing a new generation of oral integrin therapies for the treatment of serious chronic diseases, reported corporate highlights and third quarter 2020 financial results (Press release, Morphic Therapeutic, NOV 9, 2020, View Source [SID1234570467]).

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"During the third quarter, Morphic made the most noteworthy progress yet in our mission to deliver the first generation of oral medicines targeting integrin receptors. In September, we announced that the first healthy volunteers received MORF-057 in a phase 1 clinical trial designed to generate safety and pharmacokinetic data, as well as to measure levels of α4β7 receptor occupancy, a key potential proof-of-concept biomarker in inflammatory bowel disease," said Praveen Tipirneni, M.D., president and chief executive officer of Morphic Therapeutic. "MORF-057 is the first in our pipeline of selective integrin inhibitor candidates generated by the MInT Platform to enter clinical trials. Further, AbbVie recently exercised its option to exclusively license our αvβ6 integrin inhibitor program for the treatment of fibrotic diseases. AbbVie’s decision further validates the MInT Platform and our team’s ability to generate high quality small molecule integrin inhibitors and to design and execute rigorous discovery and development programs."

Morphic is developing MORF-057 as a selective, oral small molecule inhibitor of the α4β7 integrin, a target for the treatment of inflammatory bowel disease (IBD) with an initial focus on moderate-to-severe ulcerative colitis (UC). The mechanism of α4β7 inhibition to treat IBD has been clinically validated by the approved infused antibody therapy, vedolizumab.

Third quarter and recent corporate highlights:

Initiated a phase 1 clinical trial of MORF-057 in healthy volunteers
The randomized, double-blind, placebo-controlled, single and multiple ascending dose study in healthy adults will evaluate the safety, tolerability, pharmacokinetic and pharmacodynamic properties of MORF-057; a concurrent food effect study will also be conducted
The full data set from the trial is expected to be presented at a major medical conference by mid-2021 with potential release of initial single-ascending dose cohort results in first quarter 2021, including key safety and receptor occupancy data

Announced AbbVie exercised its option to exclusively license the αvβ6 integrin inhibitor program for fibrotic diseases

AbbVie paid Morphic a license fee of $20.0 million, with future potential regulatory and commercial milestones and royalties from the sales of any commercialized candidates
The exclusive license covers Morphic’s αvβ6 integrin specific program, including the compounds MORF-720 and MORF-627, discovered from the MInT Platform, Morphic’s proprietary platform for the discovery of oral integrin drugs

Presented additional preclinical data on the MORF-057 program at United European Gastroenterology (UEG) Week Virtual 2020

The UEG data reinforce the high potency and selectivity of MORF-057 for its integrin target, α4β7, through ex vivo human translational biomarkers
These data further reinforce the potential for MORF-057 to act through the same clinically validated mechanism as the approved injectable, infused antibody, vedolizumab, but using a potentially more convenient oral small molecule
Notably, these data also validated a novel physiologically relevant assay to measure α4β7 receptor occupancy in human whole blood, a key pharmacodynamic marker being studied in the ongoing phase 1 clinical trial of MORF-057
Financial Results for Third Quarter 2020

Net income for the quarter ended September 30, 2020 was $5.4 million or $0.17 per share, diluted compared to a net loss of $8.9 million or $0.30 per share, basic and diluted for the same quarter last year.

Revenue was $25.8 million for the quarter ended September 30, 2020 compared to $5.7 million for the same quarter last year. The increase was primarily due the receipt of a $20.0 million payment triggered by AbbVie exercising their option to Morphic’s αvβ6 program
Research and development expenses were $16.0 million for the quarter ended September 30, 2020, compared to $12.6 million in the same quarter last year. The $3.4 million increase year-over-year reflects clinical, development and manufacturing costs associated with our lead wholly owned α4β7 clinical program; and increased personnel-related costs to support continued progress with the company’s pipeline
General and administrative expenses were $4.8 million for the quarter ended September 30, 2020, compared to $2.9 million in the same quarter last year. The $1.9 million increase year-over-year was primarily attributable to increased headcount and higher professional fees to operate as a public company along with consulting fees associated with ongoing business development activities
As of September 30, 2020, Morphic had cash, cash equivalents, and marketable securities of $213.1 million, compared to $237.0 million at the end of 2019. Through utilization of at-the-market (ATM) offerings during the third quarter of 2020, Morphic raised net proceeds of $6.3 million. Morphic believes its cash, cash equivalents, and marketable securities balance as of September 30, 2020 will be sufficient to fund operating expenses and capital expenditure requirements into at least the end of 2022.

On November 9, 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 September 30, 2020 (Press release, Galectin Therapeutics, NOV 9, 2020, View Source [SID1234570466]). 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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Joel Lewis, Chief Executive Officer and President of Galectin Therapeutics, said, "With the June launch of our innovative NASH-RX clinical trial, we now have one of the very few, if not only, active late stage trial of patients with compensated NASH-cirrhosis, where the medical need is greatest. Continuing our progress, the first patient was randomized in August and we are enrolling patients and adding sites to this global clinical trial of belapectin, our proprietary galectin-3 inhibiting compound. We believe our innovative trial design, experienced medical and clinical teams and clear primary endpoint provide a strong foundation for success. A positive result will be very clinically relevant. If the trial shows that belapectin is effective and safe, it will be a medical breakthrough for patients with NASH cirrhosis."

"As I close out my first quarter as the head of Galectin Therapeutics, I want to reiterate how excited I am to be leading this team," concluded Lewis. "I also want to thank the investigators and patients who will participate in our NASH-RX trial. Without your commitment, there is no way the company would be where we are today nor would we have a future."

Richard E. Uihlein, Chairman of the Board, added, "Galectin Therapeutics is competitively well-positioned in the industry, and we are fortunate to have Joel leading these efforts. I am also glad to welcome Mr. Richard Zordani and Dr. Elissa Schwartz to our Board of Directors, both seasoned professionals that will strengthen our financial and clinical capabilities, respectively."

"Success in NASH cirrhosis potentially opens new treatment possibilities for belapectin’s use in other types of liver cirrhosis and in other forms of organ fibrosis affecting kidney, lung, as well as other organs. More research is warranted to expand our understanding of galectins and the role that a galectin-3 inhibitor like belapectin may play in preventing and treating disease. Thus, our NASH-RX trial will set the stage for realizing the full potential of our proprietary compound, belapectin."

Summary of Key Development Programs and Updates

On June 30 announced that we had enrolled our first patients in the NASH-RX trial. NASH-RX is an international, seamless, adaptively-designed Phase 2b/3 trial of our galectin-3 inhibitor belapectin (GR-MD-02), the company’s lead compound, in nonalcoholic steatohepatitis (NASH) cirrhosis patients who have clinical signs of portal hypertension and are at risk of developing esophageal varices. Belapectin had previously been shown that it could prevent the development of new varices in this patient population in the Phase 2 NASH-CX clinical trial (Gastroenterology 2020;158:1334–1345 or View Source).

Announced the appointment of current board member, Joel Lewis, to the position of Chief Executive Officer (CEO) and President. In this position, Mr. Lewis will set corporate strategy and oversee operations, most importantly the Company’s global NASH-RX adaptively-designed trial for the prevention of varices in NASH cirrhosis patients using its proprietary galectin-3 inhibiting compound, belapectin (GR-MD-02).

Engaged Dr. Harold Shlevin, who retired from the CEO position, to a consulting agreement through which he has agreed to devote significant effort to advancing the NASH-RX trial and will remain a member of the Board of Directors.

Enhanced its Board of Directors with the addition of two additional directors, Mr. Richard Zordani and Dr. Elissa Schwartz. Mr. Zordani is a seasoned financial executive with extensive public accounting and Family Office experience and has assumed the role of Audit Committee Chairman. Dr. Schwartz has extensive experience in epidemiology and clinical research, biomathematics, and biostatistics, which complements the Company’s clinical development capabilities.

Hosted a virtual conference call and webinar with the investment community on September 29th that provided a comprehensive description and update on the status of the NASH-RX trial and introduced our new CEO, Joel Lewis.
A replay of the Investor Call can be accessed at this link: View Source
About the NASH-RX Trial

The NASH-RX trial will use a seamless, adaptive design to confirm dose selection and reaffirm the observed efficacy of belapectin to prevent the development of esophageal varices in the NASH-CX trial. Pre-planned adaptations will inform the larger Phase 3 trial component. NASH-RX is expected to enroll approximately 315 NASH cirrhotic patients in the Phase 2b part of the trial at approximately 130 sites in 12 countries in North America, Europe, Asia and Australia.
Financial Results

For the three months ended September 30, 2020, the Company reported a net loss applicable to common stockholders of $5.955 million, or ($0.10) per share, compared to a net loss applicable to common stockholders of $2.819 million, or ($0.05) per share for the three months ended September 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 September 30, 2020 was $4.780 million compared with $1.503 million for the three months ended September 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 September 30, 2020, were $1.146 million, down from $1.360 million for the three months ended September 30, 2019, primarily due to a decrease in stock-based compensation expenses.

As of September 30, 2020, the Company had $32.6 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 December 31, 2021.

The Company expects that it will require more cash to fund operations after December 31, 2021 and believes it will be able to obtain additional financing as needed. Currently, we expect to require an additional approximately $40 million to cover costs of the trial to reach the planned interim analysis estimated to occur in the second quarter of 2023 along with drug manufacturing and other scientific support activities and general and administrative costs. These costs will require additional funding. There can be no assurance that we will be successful in obtaining financing to support our operations beyond December 31, 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 NASH 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. Belapectin binds to galectin-3 and disrupts its function. Preclinical data in animals have shown that belapectin has robust treatment effects in reversing liver fibrosis and cirrhosis. Galectin-3 has a significant role in cancer and the Company is supporting a Phase 1 study in combined immunotherapy of belapectin and Keytruda in treatment of advanced melanoma and in head and neck cancer.

About Non-alcoholic steatohepatitis (NASH) with Advanced Fibrosis and Cirrhosis
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 currently the only curative treatment available. There are no drug therapies approved for the treatment of liver fibrosis or cirrhosis.

On November 9, 2020 Verrica Pharmaceuticals Inc. ("Verrica") (Nasdaq: VRCA), a dermatology therapeutics company developing medications for skin diseases requiring medical interventions, reported financial results for the third quarter ended September 30, 2020 (Press release, Verrica Pharmaceuticals, NOV 9, 2020, View Source [SID1234570465]).

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"We are encouraged by our recent Type A meeting with the FDA in which we discussed the steps required for resubmission of the NDA for VP-102, our lead product candidate, for the treatment of molluscum," said Ted White, Verrica’s President and Chief Executive Officer. "We have also received feedback from the FDA on our Human Factors study protocol, and believe we have clear alignment on the path forward to resubmit the NDA, which we anticipate in the first quarter of 2021. In addition, we have continued to engage with Torii as they evaluate the option to exclusively license VP-102 in Japan for the treatment of molluscum contagiosum and common warts. We also strategically expanded our product portfolio into dermatologic cancers, with an initial focus on non-melanoma skin cancers, one of the most common disease states in dermatology."

Business Highlights and Recent Developments

In October 2020, Verrica participated in a Type A meeting with the FDA to discuss issues raised in the Complete Response Letter for the NDA for VP-102 for the treatment of molluscum. Verrica expects to receive the minutes from the meeting in the coming weeks, followed by resubmission of the NDA pursuant to the statutory 505(b)(1) regulatory pathway in the first quarter of 2021.

The positive results from the Company’s two pivotal Phase 3 CAMP studies evaluating the safety and efficacy of VP-102 in children and adults with molluscum were published in the Journal of the American Medical Association (JAMA) Dermatology on September 23, 2020. The results were previously presented at the 2019 American Academy of Dermatology (AAD) annual meeting in a late-breaking oral presentation.

In August 2020, Verrica was granted a United States utility patent (US 10,745,413) protecting synthetic methods for manufacturing cantharidin. Also in August 2020, a U.S. design patent application protecting the design of Verrica’s VP-102 applicator device received an allowance from the United States Patent and Trademark Office (USPTO). The resulting United States design patent (US D900,312) was granted in October 2020.
Financial Results

Third Quarter 2020 Financial Results

Verrica reported a net loss of $10.5 million for the third quarter of 2020, compared to a $6.1 million net loss for the same period in 2019.
Research and development expenses were $5.0 million in the third quarter of 2020, compared to $3.0 million for the same period in 2019. The increase was primarily attributable to increased CMC (Chemistry, Manufacturing, and Controls) costs related to Verrica’s development of VP-102 for molluscum contagiosum and increased compensation costs, partially offset by decreased clinical costs related to Verrica’s development of VP-102 for molluscum contagiosum, external genital warts, and common warts.
General and administrative expenses were $4.6 million in the third quarter of 2020, compared to $3.5 million for the same period in 2019. The increase was primarily a result of expenses related to increased headcount, an increase in insurance, professional fees and other operating costs, and an increase in expenses related to pre-commercial activities for VP-102.
Year-to-Date September 2020 Financial Results

Verrica reported a net loss of $29.7 million for the nine months ended September 30, 2020, compared to a $20.6 million net loss for the same period in 2019.
Research and development expenses were $13.4 million for the nine months ended September 30, 2020, compared to $11.5 million for the same period in 2019. The increase was primarily attributable to increased CMC costs related to Verrica’s development of VP-102 for molluscum contagiosum and increased compensation costs, partially offset by decreased clinical costs related to Verrica’s development of VP-102 for molluscum contagiosum.
General and administrative expenses were $14.7 million for the nine months ended September 30, 2020, compared to $10.6 million for the same period in 2019. The increase was primarily a result of expenses related to increased headcount, an increase in insurance, professional fees and other operating costs, and an increase in expenses related to pre-commercial activities for VP-102.
As of September 30, 2020, Verrica had aggregate cash, cash equivalents, and marketable securities of $71.9 million, which the Company believes will be sufficient to support planned operations at least through the fourth quarter of 2021.