On November 10, 2020 Cumberland Pharmaceuticals Inc. (NASDAQ: CPIX), a specialty pharmaceutical company, reported a company update and third quarter 2020 financial results (Press release, Cumberland Pharmaceuticals, NOV 10, 2020, View Source [SID1234570496]). Net revenues from continuing operations during the quarter were $9.3 million. The company also recorded an additional $750,000 in revenue during the third quarter associated with divested product rights for two brands it is no longer distributing.

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The Company’s financial position included $96 million in total assets – with $27 million in cash, $48 million of total liabilities, and $48 million of shareholders’ equity at the end of the quarter.

"As we move to the close of 2020, we recognize that it has been a particularly difficult year with the pandemic impacting all our daily lives," said A.J. Kazimi, Chief Executive Officer of Cumberland Pharmaceuticals. "Overall, our third quarter was quite successful, given all the challenges of operating a business in the wake of the pandemic. We were able to generate solid financial performance and advance on important initiatives."

RECENT COMPANY DEVELOPMENTS:

Vibativ

Cumberland’s Vibativ product is being used to help COVID-19 patients who develop bacterial infections in their lungs. Vibativ is a patented, FDA-approved injectable anti-infective for the treatment of certain serious bacterial infections including hospital-acquired and ventilator-associated bacterial pneumonia that can result from COVID-19, flu, and other infections. It addresses a range of Gram-positive bacterial pathogens, including those that are considered difficult-to-treat and multidrug-resistant.

RediTrex Launch

The Company is now finalizing plans for the launch of its newly FDA-approved RediTrex product line. Cumberland will initially implement a soft launch during the fourth quarter of 2020 and intends to follow with a full commercial launch of the brand next spring. The Company believes that RediTrex will be a valuable addition to the portfolio and help further diversify and grow its business.

RediTrex is approved for patients with severe, active rheumatoid arthritis and polyarticular juvenile idiopathic arthritis who have difficulty tolerating or responding to orally delivered methotrexate. It is also approved for symptomatic control of severe, recalcitrant, disabling psoriasis in adults who are not adequately responsive to other forms of therapy.

Caldolor Clinical Manuscripts

During the third quarter, Cumberland announced a study published in the Journal of Orthopedic Trauma, evaluating the efficacy of Caldolor administration in the management of acute pain in orthopedic trauma patients. The study also measured Caldolor’s ability in minimizing opioid use. This single-center, randomized, double-blind, placebo-controlled study found that Caldolor (ibuprofen) Injection reduced the quantity of opioids required to manage pain after a traumatic injury with fracture. In addition, the time to first narcotic medication was longer in the Caldolor group than with hospital standard of care. Pain was also managed better in the Caldolor group compared to standard of care narcotics.

Additionally, the results of a review of nine clinical studies evaluating Caldolor was announced. The comprehensive review was published in the journal, Clinical Therapeutics, and involved over 1,000 adult patients, with over 750 receiving Caldolor and another 300 receiving placebo or a comparator medication. The data noted that the use of Caldolor improved post-surgery recovery, decreased surgical stress, and reduced the use of opioids and over-the-counter medication. The study review determined that patients given Caldolor experienced less postoperative pain and decreased opioid use. Study authors also concluded that the rapid administration and preemptive use of Caldolor should be considered in Enhanced Recovery After Surgery protocols for the management of postoperative pain including that of traumatic origin.

Revolving Credit Loan Agreement

In October 2020, Cumberland entered into a Third Amendment to the Revolving Credit Note and Fourth Amendment ("Fourth Amendment") to the Revolving Credit Loan Agreement with Pinnacle Bank (the "Pinnacle Agreement"). The original Pinnacle Agreement was dated July 31, 2017. The Fourth Amendment provides for a principal available for borrowing of up to $15 million and Cumberland has the ability to request an increase of up to an additional $5 million, upon the satisfaction of certain conditions and approval by Pinnacle Bank. If fully expanded, the Fourth Amendment would provide a maximum principal available for borrowing of up to $20 million, which was also the maximum aggregate principal available for borrowing under the previously amended Pinnacle Agreement.

The Fourth Amendment extends the maturity date of the Pinnacle Agreement through October 1, 2022.

Ifetroban Phase II Clinical Programs

Enrollment in Cumberland’s clinical studies significantly slowed during 2020 due to the COVID-19 pandemic. While enrollment of new patients was limited, the Company ensured that patients already entered into a trial continued to receive their study drug.

During the third quarter, some of Cumberland’s clinical study sites reopened and resumed screening of patients for potential enrollment into the Company’s studies.

Cumberland has completed a pilot Phase II study involving ifetroban in patients suffering from aspirin-exacerbated respiratory disease, a severe form of asthma. A follow-up Phase II study is currently underway for this asthma indication.

The Company is also currently evaluating ifetroban in two pilot Phase II studies in 1) patients with systemic sclerosis or scleroderma, a debilitating autoimmune disorder characterized by diffuse fibrosis of the skin and internal organs and 2) patients with cardiomyopathy associated with Duchenne Muscular Dystrophy. This rare, fatal, genetic neuromuscular disease results in deterioration of the skeletal, heart and lung muscles.

Cumberland is awaiting further study results before deciding on the best path for approval for ifetroban, its first new chemical entity.

FINANCIAL RESULTS:

Net Revenues: For the three months ended September 30, 2020, net revenues from ongoing operations were $9.3 million, compared to $6.9 million for the prior year period. The company also recorded an additional $750,000 in revenue during the third quarter associated with divested product rights.

Net revenue by product for the three months ended September 30, 2020, included $3.6 million for Kristalose, $2.8 million for Vibativ, $1.4 million for Caldolor, $0.2 million for Acetadote (including the brand and Company’s Authorized Generic), $0.5 million for Omeclamox-Pak, and $0.4 million for Vaprisol

For the nine months ended September 30, 2020, net revenues were $27.2 million, up 8.4% from $25.1 million for the prior year period.

Operating Expenses: Total operating expenses for the three months ended September 30, 2020 were $10.5 million, compared to $10.1 million during the prior year period.

Total operating expenses for the first nine months of 2020 were $31.8 million compared to $31.0 million for the nine months ended September 30, 2019.

Earnings: Net income (loss) for the third quarter 2020 was $(0.5) million or $(0.03) a share, compared to $(2.0) million or $(0.13) a share for the prior year period.

Adjusted Earnings (loss) for the third quarter were $0.2 million or $0.02 per diluted share, compared to $(1.7) million or $(0.11) per diluted share for the prior year period.

Balance Sheet: At September 30, 2020, Cumberland had $96.0 million in total assets including $26.6 million in cash and cash equivalents. Total liabilities were $48.2 million, including $17.0 million outstanding on the Company’s revolving line of credit, resulting in total shareholders’ equity of $47.9 million.

Conference Call and Webcast

A conference call and live internet webcast will be held on Tuesday, November 10, at 4:30 p.m. Eastern Time to discuss the results. To participate in the call, please dial 877-303-1298 (for U.S. callers) or 253-237-1032 (for international callers). A rebroadcast of the teleconference will be available for one week and can be accessed by dialing 855-859-2056 (for U.S. callers) or 404-537-3406 (for international callers). The Conference ID for the rebroadcast is 4484046. The live webcast and rebroadcast can be accessed via Cumberland’s website at View Source

On November 10, 2020 Phio Pharmaceuticals Corp. (Nasdaq: PHIO), a biotechnology company developing the next generation of immuno-oncology therapeutics based on its proprietary self-delivering RNAi (INTASYL) therapeutic platform, reported its financial results for the quarter ended September 30, 2020 and provided a business update (Press release, Phio Pharmaceuticals, NOV 10, 2020, View Source [SID1234570495]).

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"During the quarter, we continued to execute on the development of our INTASYL RNAi technology as a cancer immunotherapy platform for innovative therapeutics. Promising new in vivo data was recently presented at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) annual meeting. This data showed that our INTASYL compounds targeting PD-1, PD-L1 or TIGIT inhibited tumor growth, and that such antitumoral effect can be significantly improved by combining different INTASYL compounds without having a negative impact on the tolerability of the treatment," said Dr. Gerrit Dispersyn, President and CEO of Phio. "Immune checkpoint therapy with systemic antibodies can result in dose limiting toxicities, especially when used in combination. With our INTASYL platform, we can easily combine multiple targets in a single therapeutic. Our data suggest that local administration with INTASYL compounds, even when used in combination, may provide a safer and more cost-effective alternative to antibody-based immune checkpoint therapy. Based upon these exciting results, we look forward to finalizing our IND-enabling studies and to moving our INTASYL compounds into the clinical phase of development in the near future."

Quarter in Review and Recent Corporate Updates

Presented data at the AACR (Free AACR Whitepaper) Virtual Annual Meeting II on PH-804, an INTASYL compound targeting TIGIT, inhibiting tumor growth and conferring an inflammatory tumor microenvironment.
Presented data at SITC (Free SITC Whitepaper) 2020 showing that the antitumoral efficacy of our PH-762, PH-790 and PH-804 INTASYL compounds can be further improved by combining them in a single drug treatment.
Collaborated on poster presentations featuring INTASYL RNAi technology by two development partners, AgonOx, Inc. and the Helmholtz Zentrum München that were presented at SITC (Free SITC Whitepaper) 2020.
Attended and presented at the H.C. Wainwright 22nd Annual Global Investment Conference.
Conducted preclinical work to support the planned initiation of clinical trials with PH-762.
Ended the quarter with total cash of approximately $16.9 million as of September 30, 2020.
Financial Results

Cash Position

At September 30, 2020, the Company had cash of $16.9 million as compared with $6.9 million at December 31, 2019. The Company expects its cash will be sufficient to fund currently planned operations for at least the next 12 months.

Research and Development Expenses

Research and development expenses were approximately $1.3 million for the quarter ended September 30, 2020, compared to approximately $1.0 million for the quarter ended September 30, 2019. The increase is primarily due to an increase in the use of third-party service providers to conduct preclinical research studies to support the development of the Company’s pipeline programs as compared to the prior year period offset by a decrease in the use of an outside interim temporary labor consultant in the prior year period.

General and Administrative Expenses

General and administrative expenses were relatively steady at $1.1 million for the three-month periods ended September 30, 2020 and 2019.

Net Loss

Net loss was $2.3 million, or $0.40 per share, for the quarter ended September 30, 2020, compared with $2.1 million, or $4.53 per share, for the quarter ended September 30, 2019. The increase in net loss was primarily attributable to an increase in research and development expenses, as discussed above. The change in net loss per share was primarily due to an increase in the number of shares outstanding as a result of our capital raise activities as compared to the prior year period.

On November 10, 2020 Lumos Pharma, Inc. (NASDAQ:LUMO), a clinical-stage biopharmaceutical company focused on therapeutics for rare diseases, reported financial results for the third quarter ended September 30, 2020 and provided an update on clinical activities (Press release, NewLink Genetics, NOV 10, 2020, View Source [SID1234570494]).

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"This past quarter was marked by significant achievements leading to the initiation of our Phase 2b OraGrowtH210 Trial evaluating oral LUM-201 in pediatric growth hormone deficiency patients and the previously announced sale of our PRV in July," commented Rick Hawkins, Chairman, CEO and President of Lumos Pharma. "We are thrilled to advance our LUM-201 program and look forward to building upon this momentum as we continue our efforts to expand our business and pipeline."

Corporate Updates

Initiation of Phase 2b OraGrowtH210 Trial – Lumos Pharma announced the initiation of its Phase 2b OraGrowtH210 trial evaluating oral LUM-201 in pediatric growth hormone deficiency (PGHD) patients. The trial will evaluate three dose levels of LUM-201 in PGHD patients against a comparator arm of standard-of-care injectable growth hormone therapy. Dosing will be administered over six months, with annualized growth height velocity as the primary clinical outcome measure. The purpose of this trial will be to prospectively confirm our Predictive Enrichment Marker (PEM) strategy and to identify the optimal dose of LUM-201 to be used in a registration trial. The Company anticipates data read out for the OraGrowtH210 Trial mid-year 2022.
Received First Tranche of PRV Sale Funds – Lumos received the first tranche of $34 million from the total $60 million due to the Company from the PRV sale and anticipates the receipt of the second tranche of $26 million in Q1 2021. We anticipate these funds will serve as additional capital to support the expansion of the Company’s pipeline through the licensure of another novel therapeutic candidate for those suffering from rare diseases.
Pharmacokinetic/Pharmacodynamic OraGrowtH212 Trial of LUM-201 in PGHD Remains on Track – The Company continues to prioritize the initiation of its second concurrent trial of LUM-201 in PGHD and remains on track to initiate the OraGrowtH212 Trial in Q1 2021.
Financial Results for the Three-Month Period Ended September 30, 2020

Cash Position: Lumos Pharma ended the quarter on September 30, 2020, with cash and cash equivalents totaling $105.6 million compared to Lumos Pharma prior to its merger with NewLink Genetics cash of $5.0 million December 31, 2019 and pro forma December 31, 2019 cash of $95.5 million, inclusive of NewLink Genetics. The Company expects its cash on hand is sufficient to fund current operations through the read-out of our Phase 2b OraGrowtH210 Trial and completion of the OraGrowtH212 Trial.
R&D Expenses: Research and development expenses for the three months ended September 30, 2020 were $2.1 million, an increase of $0.9 million from $1.2 million for the same period in 2019. The increase is primarily due to increases of $0.7 million in clinical trial expenses, $0.2 million in personnel-related and stock compensation expenses, $0.2 million in supplies and other expenses and $0.1 million in legal expenses, offset by a decrease of $0.3 million in contract manufacturing expense.
G&A Expenses: General and administrative expenses for the three months ended September 30, 2020 were $5.2 million, an increase of $3.7 million from $1.5 million for the same period in 2019. The increase was due primarily to increases of $2.6 million in personnel-related and stock compensation expenses and $1.1 million in operating expenses for insurance, rent, supplies, and depreciation expenses.
Net Income (Loss): The net income for the three months ended September 30, 2020 was $1.8 million compared to a net loss of $2.7 million for the same period in 2019.
Lumos Pharma ended Q3 2020 with 8,293,312 shares outstanding.
Conference Call and Webcast Details

The Company has scheduled a conference call and webcast for 4:30 p.m. ET today to discuss its financial results and to give an update on clinical and business development activities. There will also be a question and answer session following management’s prepared remarks.

Access to the live conference call is available five minutes prior to the start of the call by dialing (855) 469-0612 (U.S.) or (484) 756-4268 (international). The conference call will be webcast live and a link to the webcast can be accessed through the Lumos Pharma website at www.lumos-pharma.com in the "Investors & Media" section under "Events and Presentations" or through this link: View Source To ensure a timely connection, it is recommended that users register at least 10 minutes prior to the scheduled webcast. A replay of the call will be available approximately two hours after the completion of the call and can be accessed by dialing (855) 859-2056 (U.S.) or (404) 537-3406 (international) and using the passcode 1076873. The replay will be available for two weeks from the date of the call.

On November 10, 2020 Viela Bio (Nasdaq:VIE), a biotechnology company dedicated to the discovery, development and commercialization of novel treatments for autoimmune and severe inflammatory diseases, reported financial results and provided program highlights for the third quarter ended September 30, 2020 (Press release, Viela Bio, NOV 10, 2020, View Source [SID1234570493]).

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"Several months into UPLIZNA’s launch, we have gained valuable insights into how to meet our customer’s needs, which continue to evolve during the COVID-19 pandemic. We are encouraged by the increasing product uptake and our commercial team remains nimble in how we engage with individual practitioners and centers of excellence across the U.S.," said Bing Yao, Ph.D., Chief Executive Officer at Viela Bio. "As we and our partners await the potential approval of UPLIZNA in several Asian countries, we continue to expand its development in the U.S. in various diseases, including myasthenia gravis and IgG4-related disease, where we believe it could have a significant clinical benefit over existing therapies."

Added Dr. Yao: "While we pursue the potential expansion of UPLIZNA to additional patient populations, we continue to make solid progress across our entire pipeline. Recently, we presented data from our Phase 1b study of VIB7734 in an oral presentation at ACR Convergence 2020, confirming its potential to reduce lesions in lupus patients and have selected systemic lupus erythematosus for our planned Phase 2 trial. Additionally, we continue to enroll new patients into our ongoing trials with VIB4920, which include mid-stage studies in Sjögren’s syndrome, rheumatoid arthritis and kidney transplant rejection and are planning to submit an IND for a new preclinical candidate by the end of this year."

PROGRAM HIGHLIGHTS

UPLIZNA (inebilizumab-cdon)
UPLIZNA is a CD19-directed cytolytic antibody indicated for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4) antibody positive.

As part of its commercialization strategy for UPLIZNA, Viela continues to focus on both centers of excellence and community neurologists throughout the U.S. To date, UPLIZNA has been prescribed to a mix of newly diagnosed patients and those experiencing an inadequate response to their current maintenance regimen.
Viela recently initiated a Phase 3 trial with inebilizumab in patients with myasthenia gravis, a chronic, rare autoimmune neuromuscular disorder which affects about 56,000 people in the U.S.
Viela initiated a Phase 3 trial in patients with IgG4-related disease, a group of disorders marked by tumor-like swelling and fibrosis of affected organs.
The Phase 2 trial for kidney transplant desensitization remains voluntarily paused due to the COVID-19 pandemic.
Regulatory applications have been filed in several Asian countries based on results from the N-MOmentum study. If approved, Mitsubishi Tanabe Pharma Corporation (MTPC) and Hansoh Pharma—Viela’s partners in Asia—will be responsible for commercializing inebilizumab in their respective territories, and Viela will be eligible for payments based on certain commercial milestones, as well as royalties on sales revenue.
VIB4920
VIB4920 is an investigational fusion protein designed to bind to CD40L on activated T cells, blocking their interaction with CD40-expressing B cells.

Viela is currently conducting a Phase 2b trial with VIB4920 in Sjögren’s syndrome in addition to Phase 2 trials in patients with kidney transplant rejection and rheumatoid arthritis. Due to the COVID-19 pandemic, new patient enrollment in the Sjögren’s syndrome and kidney transplant rejection trials had been voluntarily paused, but has recently resumed in both trials.
VIB7734
VIB7734 is designed to target and bind to ILT7, a cell surface molecule specific to pDCs, leading to their depletion. This depletion may also decrease other inflammatory cytokines such as TNF-alpha and IL-6, which are critical to the pathogenesis of a number of autoimmune diseases.

Viela recently reported the final data from its Phase 1b trial with VIB7734 in an oral presentation during a late-breaking session at the American College of Rheumatology (ACR) Convergence 2020—a premiere medical conference for inflammatory disease research. The results confirmed previously reported data, demonstrating that VIB7734 effectively reduced blood and skin plasmacytoid dendritic cells, leading to reduced type I Interferon levels in the blood and inflamed skin of patients with cutaneous lupus erythematosus (CLE). More CLE subjects treated with VIB7734 than placebo had a clinically significant improvement in CLASI-A scores—a scale that quantifies skin disease activity. Rates of adverse events were similar between VIB7734 and placebo groups.
Based on results from the Phase 1b study, Viela has selected systemic lupus erythematosus (SLE) as the lead indication of a planned Phase 2 trial, anticipated to initiate in H1 2021.
Viela is currently enrolling patients into its Phase 1 study with VIB7734 for the treatment of COVID-19-related acute lung injury. Results from this study are anticipated in H1 2021, at which time the Company will decide whether to pursue additional clinical trials in this indication.
FINANCIAL RESULTS

Total net product sales for the third quarter of 2020 were $2.3 million, resulting from sales of UPLIZNA. The company did not generate product sales in the third quarter of 2019.
For the third quarter of 2020, Viela reported a net loss of $37.6 million, compared to a net loss of $48.4 million for the third quarter of 2019. As of September 30, 2020, Viela had $387.5 million in cash, cash equivalents, and investments and no outstanding debt. Research and development expenses were $26.0 million for the third quarter of 2020, which include $1.4 million of non-cash stock-based compensation expenses.
Selling, general and administrative expenses were $14.0 million for the third quarter of 2020, which include $2.0 million of non-cash stock-based compensation expenses.
Total operating expenses for the third quarter of 2020 totaled $38.2 million, compared to $48.9 million for the third quarter of 2019. Non-cash share-based compensation expenses totaled $3.4 million for the third quarter of 2020, compared to $0.9 million for the third quarter of 2019.
Conference Call and Webcast
The Company will host a live webcast and conference call to discuss financial results and program highlights for the third quarter of 2020 today at 5:00 p.m. EST.

The webcast will be accessible on the Events & Presentations page of Viela Bio’s website. Individuals can participate in the conference call by dialing (877) 783-8848 (domestic) or (631) 350-0960 (international) and referring to conference ID #: 1237908.

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

On November 10, 2020 Pliant Therapeutics, Inc. (Nasdaq: PLRX) (the Company), a clinical stage biotechnology company focused on discovering and developing novel therapeutics for the treatment of fibrosis, reported third quarter 2020 financial results (Press release, Pliant Therapeutics, NOV 10, 2020, View Source [SID1234570492]).

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"Reflecting back on the first three quarters of 2020, I’m proud of the progress we’ve made despite the challenges related to the COVID-19 pandemic," said Bernard Coulie, M.D., Ph.D., Chief Executive Officer and President of Pliant Therapeutics. "We closed a successful IPO, took important steps in advancing our clinical programs across four indications, and further strengthened our leadership team. Looking ahead, with a strong cash position to advance our robust pipeline, we remain deeply committed to bringing novel treatments to people with fibrotic diseases."

Recent Highlights

Enrollment of Phase 2a 12-week trials of PLN-74809 in idiopathic pulmonary fibrosis (IPF) and primary sclerosing cholangitis (PSC) progressing. After resuming enrollment earlier in the year, Pliant has remained in close coordination with its global trial sites in order to facilitate enrollment in both Phase 2a trials. The Company also continues to open additional trial sites as COVID-19 related restrictions are eased. The hybrid approach to clinical trial participation utilizing home-health solutions to maximize patient safety is expected to aid in trial recruitment.
Phase 2a PET imaging trial of PLN-74809 in IPF is enrolling. The Phase 2a PET trial will evaluate safety, tolerability, and target engagement of PLN-74809 in IPF patients. We expect to report preliminary data by the first half of 2021.
Completed dosing of an extended Phase 1 dose escalation trial of PLN-74809 in healthy volunteers. PLN-74809 has completed dosing multiple ascending dose cohorts of 120mg and 160mg once daily in an extended dose escalation trial. The pharmacokinetic profile remains in line with previous cohorts, and PLN-74809 remains generally well tolerated with no drug related severe adverse events or serious adverse events reported in either cohort.
Phase 2a trial of PLN-74809 treatment of COVID-19 related acute respiratory distress syndrome (ARDS) has been initiated. The Company initiated a Phase 2a trial evaluating safety, tolerability and pharmacokinetics (PK) of PLN-74809, as well as exploratory clinical outcome measures in patients hospitalized with severe and critical COVID-19.
Phase 1 trial of PLN-1474 in healthy volunteers is nearing completion. The Phase 1 trial is designed to evaluate safety and tolerability, as well as PK of PLN-1474 in approximately 100 healthy volunteers across a dose range compared to placebo. After resuming enrollment following delays related to COVID-19, the trial remains on track to deliver topline data by the first quarter of 2021. PLN-1474 is partnered with Novartis.
COVID-19 Preparedness

Pliant continues to develop policies and procedures to enable the Company to operate safely and productively during the COVID-19 pandemic. The Company has experienced delays in clinical trial operations which have impacted, and may further impact the expected timing of data readouts. Pliant is working closely with clinical sites to continue site initiation and operation activities in compliance with study protocols while observing government and institutional guidelines. The Company intends to provide more specific guidance regarding clinical trial progress and the timing of data readouts as the impacts of the pandemic become better understood.

Third-Quarter 2020 Financial Results

Related party revenue was $4.8 million, as compared to none for the prior-year quarter.
Research and development expenses were $16.9 million, as compared to $10.8 million for the prior-year quarter. The increase was due primarily to higher costs related to the advancement of several programs and ongoing Phase 1/2 clinical trials.
General and administrative expenses were $4.6 million, as compared to $2.6 million for the same period in 2019. The increase was due to higher personnel-related and professional services expenses.
Net loss of $16.5 million as compared to a net loss of $13.3 million for the prior-year quarter.
As of September 30, 2020, Pliant had cash, cash equivalents and short-term investments of $294.0 million, compared to $312.5 million as of June 30, 2020. Pliant believes it has sufficient funds to meet its operating and capital requirements into 2023.