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.

On November 10, 2020 Histogen Inc. (NASDAQ: HSTO), a clinical-stage therapeutics company focused on developing potential first-in-class restorative therapeutics that ignite the body’s natural process to repair and maintain healthy biological function, reported financial results for the third quarter ended September 30, 2020 and provided an update on its clinical pipeline and other corporate developments (Press release, Conatus Pharmaceuticals, NOV 10, 2020, View Source [SID1234570491]).

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Key Third Quarter 2020 Highlights and Subsequent Updates

Received $2M Grant Award from DoD to support the HST-003 Trial for Cartilage Regeneration in the Knee. In September, Histogen was awarded a $2 million grant by the Peer Reviewed Orthopedic Research Program (PRORP) of the U.S. Department of Defense (DoD) to help fund a Phase 1/2 clinical trial of HST-003 for regeneration of cartilage in the knee. Histogen expects to start the trial in the first quarter of 2021. The Phase 1/2 clinical trial is designed to evaluate HST-003 in combination with a microfracture procedure in 15 civilian and military patients with recent focal cartilage defects in the knee caused by injury. Patients will be enrolled at three clinical sites: OasisMD in San Diego, CA, The Steadman Clinic in Vail, CO and Walter Reed Medical Center in Bethesda, MD. In addition to safety parameters, endpoints will include traditional scores for pain and joint function from The Knee Injury and Osteoarthritis Outcome Scores (KOOS) and The International Knee Documentation Committee (IKDC), as well as an MRI to quantify cartilage regeneration. The U.S. Army Medical Research Acquisition Activity, 820 Chandler Street, Fort Detrick, MD 21702, is the awarding and administering acquisition office. The views expressed in this press release are those of Histogen and may not reflect the official policy or position of the Department of the Army, Department of Defense, or the U.S. Government.

Topline Data for HST-001 Phase 1b/2a Trial for Androgenic Alopecia in Men on Track for 4Q20. Histogen announced in October that it completed dosing for week 12, the last of three dosing timepoints, in our HST-001 trial, and we remain on track to announce top line data results in the fourth quarter of this year.

Appointed Moya Daniels as Head of Regulatory, Quality and Clinical Operations. In October, Ms. Daniels joined Histogen as its Executive Vice President and Head of Regulatory, Quality and Clinical Operations. Moya brings over 30 years of experience in regulatory, quality and development in the life sciences industry to Histogen. Ms. Daniels most recently served as Senior Vice President of GMP Quality at SanBio and prior to SanBio, she held the position of Senior Vice President of Regulatory Affairs and Global Quality Assurance at Orchard Therapeutics.

Entered into a Collaborative Development and Commercialization Agreement with Amerimmune LLC to jointly develop emricasan, an orally active caspase inhibitor, for the treatment of COVID-19. Under the terms of the collaboration, Histogen will retain ownership and oversight over emricasan and responsibility for all regulatory filings and maintaining its existing caspase inhibitor patent portfolio. Amerimmune, in collaboration with Histogen, will fund and lead the emricasan development efforts and maintain its own portfolio of patents for caspase inhibition and immunotherapy. Additionally, Amerimmune has been granted an option to commercialize emricasan under certain conditions for the sole purpose of supporting future third-party partnering transactions. Should any such partnering transaction emerge, Histogen and Amerimmune will share profits equally. The parties will manage the collaboration under a joint development and partnering committee governance structure.

Received IND Approval from FDA to Initiate a Phase 1 Study of Emricasan in Mild-COVID-19 Patients. Histogen received IND approval from the FDA in October. Histogen’s partner Amerimmune will lead the development efforts for emricasan and has selected clinical sites at two major medical centers in the New York City metropolitan area to conduct the study. Amerimmune is pursuing non-dilutive funding in order to support the clinical program and anticipates initiating the Phase 1 study as early as the end of 2020.
"With our continued successful transition into a public company during the third quarter, we believe we remain on track to achieve our key strategic objectives in the fourth quarter of 2020, notably, the sharing of top-line results from our HST-001 Phase 1a/2b trial for androgenic alopecia in men, submitting the IND for HST-003, and supporting our partner, Amerimmune, in preparing for a Phase 1 study of emricasan as a potential therapeutic for the treatment of mild COVID-19 patients" said Richard W. Pascoe, Histogen’s President and Chief Executive Officer.

Financial Highlights for the Third Quarter 2020

Revenues for the three months ended September 30, 2020 and 2019, we recognized product and service revenues of $0.5 million and $0.3 million, respectively. The year-over-year increase of $0.2 million was primarily due to the fulfillment of supply orders of CCM to Allergan.

Cost of revenues for the three months ended September 30, 2020 and 2019, we recognized cost of product revenue of $0.3 million and $0.1 million, respectively. The increase of $0.2 million for the three months ended September 30, 2020 as compared to the three months ended September 30, 2019 was commensurate with the increase in product sales to Allergan.

Research and development expenses for the three months ended September 30, 2020 and 2019 were $1.5 million and $0.7 million, respectively. The increase of $0.8 million for the three months ended September 30, 2020 as compared to the three months ended September 30, 2019 was primarily due to increases related to expanded development costs of our product candidates and increases in personnel related expenses due to changes in duties and responsibilities of existing personnel.

General and administrative expenses for the three months ended September 30, 2020 and 2019 were $2.0 million and $1.2 million, respectively. The $0.8 million increase for the three months ended September 30, 2020 as compared to the three months ended September 30, 2019 was primarily due to increases in insurance, rent and legal and accounting fees, offset by decreases in personnel related expenses due to changes in duties and responsibilities of existing personnel.

Cash and cash equivalents as of September 30, 2020 were $6.6 million. The $6.6M is exclusive of any DOD grant funding which will be received only as budgeted expenses under the grant are incurred by Histogen. Histogen believes that its existing cash and cash equivalents and cash inflow from operations will be sufficient to meet Histogen’s anticipated cash needs into the second quarter of 2021.