On August 10, 2020 Cellectar Biosciences, Inc. (NASDAQ: CLRB), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of drugs for the treatment of cancer, reported financial results for the second quarter ended June 30, 2020 and provided a corporate update (Press release, Cellectar Biosciences, AUG 10, 2020, View Source [SID1234563316]).

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Second Quarter and Recent Corporate Highlights

·Received Fast Track Designation for CLR 131 in lymphoplasmacytic lymphoma (LPL)/ Waldenstrom’s macroglobulinemia (WM) from the U.S. Food and Drug Administration (FDA);

·Received Small and Medium-Sized Enterprise (SME) status from the European Medicines Agency’s (EMA) Micro, Small and Medium-sized Enterprise office. SME status allows Cellectar to participate in significant financial incentives and be eligible to obtain EMA certification of quality and manufacturing data prior to review of clinical data;

·Expanded IP coverage in Europe with the receipt of two composition of matter and use patents. The first patent expands protection for the company’s proprietary PLE targeted delivery vehicle analogs in combination with a broad range of chemotherapeutics such as paclitaxel, gemcitabine, and other classes of small molecule chemotherapeutic agents. The second patent covers the treatment and/or diagnosis of cancer and cancer stem cells with CLR 131;

·Strengthened the management team with the appointment of Dr. John Friend, chief medical officer; and

·Completed an underwritten public offering for gross proceeds of $20 million

"We continue to enroll relapsed/refractory multiple myeloma and LPL/WM patients in the Phase 2b portion of our ongoing CLOVER-1 study and prepare for the initiation of our pivotal study expected in Q4 of 2020 while advancing our Phase 1 pediatric study " said James Caruso, president and CEO of Cellectar. "We also successfully executed on other key fronts. The FDA granted CLR 131 Fast Track Designation in LPL/WM; we expanded our IP portfolio with two new European patents and significantly strengthened our balance sheet with the recent financing."

Second Quarter 2020 Financial Highlights

·Cash and Cash Equivalents: As of June 30, 2020, the company had cash and cash equivalents of $22.5 million compared to $10.6 million at December 31, 2019. Cash used in operating activities was approximately $6.6 million during the six months ended June 30, 2020 as compared to $5.5 million during the six months ended June 30, 2019.

·Research and Development Expense: R&D expense for the three months ended June 30, 2020 was $2.5 million, compared to $1.8 million for the three months ended June 30, 2019. The cumulative R&D spending for the first six months of 2020 was $5.1 million as compared to $4.1 million for the first six months of 2019. The increase in R&D expense year-to-date in 2020 was primarily a result of general R&D cost from personnel related expenses and clinical project costs. Manufacturing and related costs decreased and the costs of preclinical studies were relatively consistent.

·General and Administrative Expense: G&A expense for the three months ended June 30, 2020 was $1.2 million compared to $1.4 million for the three months ended June 30, 2019. The cumulative G&A spending for the first six months of 2020 were of $2.5 million as compared to $2.7 million for the first six months of 2019. The decrease in G&A expense year-to-date in 2020 was primarily a result of lower stock-based compensation expense.

Net Loss: The net loss attributable to common stockholders for the three months ended June 30, 2020 was ($3.6) million, or ($0.26) per share, compared to ($3.2) million, or ($0.46) per share, in 2019. Net loss attributable to common stockholders for the six months ended June 30, 2020 was ($7.6) million, or ($0.65) per share, compared to ($6.8) million, or ($1.15) per share, in 2019.

On August 10, 2020 AnaptysBio, Inc. (Nasdaq: ANAB), a clinical-stage biotechnology company developing first-in-class antibody product candidates focused on emerging immune control mechanisms applicable to inflammation and immuno-oncology indications, reported operating results for the second quarter ended June 30, 2020 and provided pipeline updates (Press release, AnaptysBio, AUG 10, 2020, View Source [SID1234563315]).

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"While we are disappointed with the recent interim analysis results from our ongoing ECLIPSE trial, we look forward to additional Phase 2 clinical trial readouts anticipated over the upcoming quarters," said Hamza Suria, president and chief executive officer of AnaptysBio. "We remain focused on the continued discovery and development of novel antibodies using our capital-efficient business model which has already advanced 7 internally-generated antibodies to the clinic to date. We also anticipate significant milestone and royalty revenues from the FDA approval of dostarlimab under our GSK partnership."

Etokimab (ANB020 Anti-IL-33) Program
•In an interim analysis at week 8 of the ongoing ECLIPSE Phase 2 trial of etokimab in chronic rhinosinusitis with nasal polyps, patients dosed with etokimab every four (q4w) or eight weeks (q8w) failed to achieve statistically significant improvement in their bilateral nasal polyps score (NPS), an endoscopic measure of nasal occlusion, and their sino-nasal outcome test (SNOT-22), a patient reported quality-of-life assessment, versus placebo at the week 8 timepoint. Both endpoints demonstrated statistically significant improvement over baseline levels of NPS and SNOT-22. Blood eosinophil levels, which are a biomarker of etokimab’s mechanism, demonstrated statistically significant reduction relative to baseline in both etokimab treatment arms. The Company intends to decide on a path forward for the etokimab program after reviewing week 16 primary endpoint data by year-end 2020.

Imsidolimab (Anti-IL-36 Receptor) Program
•In July we announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation for imsidolimab, the company’s proprietary anti-interleukin-36 receptor (IL-36R) antibody, for the treatment of patients with GPP. Treatment of GPP by imsidolimab is being evaluated in the GALLOP Phase 2 trial, where additional clinical data and a regulatory update is anticipated in the fourth quarter of 2020.
•The Company is also conducting a randomized, placebo-controlled, multi-dose Phase 2 trial in 50 patients with palmoplantar pustulosis, or PPP, also known as the POPLAR trial, with topline data anticipated in the first quarter of 2021, following COVID-19-related site closures that impacted enrollment in POPLAR during the second quarter.
•We anticipate expanding the imsidolimab program in two new indications based upon human translational data that suggests each of these conditions are mediated by dysregulated signaling through the IL-36 pathway:
◦Treatment of solid tumors with inhibitors of epidermal growth factor (EGFRi) and MAPK/ERK kinase (MEKi) is frequently limited by the occurrence of skin toxicities. These toxicities, which can lead to dose reduction and discontinuation of treatment, have been reported to occur as a result of excess IL-36 signaling, leading to IL-8-mediated cutaneous neutrophilia and acneiform rash. Based on existing claims data, approximately 60,000 patients are prescribed EGFRi and/or MEKi treatments annually, and the vast majority of these patients experience dermatological toxicity. Current standard-of-care treatments are generally ineffective in patients with the most severe grades of EGFRi and/or MEKi mediated acneiform rash. During the fourth quarter of 2020, we anticipate initiating a Phase 2 trial of imsidolimab, in combination with EGFRi/MEKi inhibitors, to assess its efficacy in the treatment of this indication.
◦Ichthyosis is a family of rare, inherited, dermatological disorders characterized by dry, scaling and thickened skin. Approximately 6,000 patients in the United States are affected with moderate-to-severe levels of ichthyosis and no approved therapies are available for this disease. Recent translational data supports the role of IL-36 signaling in ichthyosis, and we anticipate initiating a Phase 2 trial of imsidolimab in this indication during the fourth quarter of 2020.

ANB030 (Anti-PD-1 Agonist) Program
•ANB030 is a wholly-owned antibody that binds PD-1 in an agonistic manner, leading to reduced T cell activity and anti-inflammatory effects in vivo. Genetic mutations in the PD-1 pathway are associated with increased susceptibility to various inflammatory conditions and we believe ANB030 has the potential to suppress inflammatory diseases by restoring insufficient PD-1-mediated negative signaling on activated T cells. The Company plans to focus future clinical development of ANB030 on certain autoimmune diseases where PD-1 checkpoint receptor function may be under-represented. Preclinical translational data using ANB030 was presented in March 2020 at the Festival of Biologics Meeting. We initiated a Phase 1 healthy volunteer clinical trial, designed to assess the safety, pharmacokinetics and pharmacodynamics of ANB030 in single and multiple ascending dose cohorts, during the first half of 2020, and top-line data from this trial is anticipated in mid-2021.

ANB032 (Anti-BTLA Modulator) Program
•Our fourth wholly-owned program is an anti-BTLA modulator antibody, known as ANB032, which is broadly applicable to human inflammatory diseases associated with lymphoid and myeloid immune cell dysregulation. Mutations in the BTLA signaling pathway are associated

with human inflammatory disease, and we believe ANB032 silences pro-inflammatory signaling by modulating BTLA binding to HVEM. We anticipate filing an IND for ANB032 in the fourth quarter of 2020.
Dostarlimab (Anti-PD-1 Antagonist) Program Partnered with GSK
•In the first quarter of 2020, the FDA accepted the first Biologics License Application (BLA) filing for dostarlimab, an AnaptysBio-generated PD-1 antagonist antibody under partnership with GSK, for the treatment of advanced or recurrent deficient mismatch repair (dMMR) endometrial cancer. AnaptysBio received a $10.0 million cash milestone payment upon this acceptance, and anticipates an additional $20.0 million cash milestone payment upon first FDA approval of dostarlimab during the second half of 2020. Also in the first quarter of 2020, the EMA accepted GSK’s Marketing Authorization Application (MAA) for approval of dostarlimab in the EU for endometrial cancer, for which AnaptysBio has received a $5.0 million milestone payment and anticipates an additional $10.0 million cash milestone payment upon EMA approval.
•AnaptysBio also expects to receive milestone payments from GSK during 2021 for acceptance and approval by the FDA of dostarlimab in dMMR pan-tumor cancer. All milestone payment amounts for this second indication for dostarlimab will be the same as the corresponding milestone payment amounts for the first indication.
•Including additional cash milestones due upon future development and commercialization of dostarlimab, GSK4069889A, an AnaptysBio-generated TIM-3 antibody, and GSK4074386, an AnaptysBio-generated LAG-3 antibody, AnaptysBio can potentially receive a total of $1.1 billion in aggregate milestone payments under this GSK partnership. In addition, AnaptysBio is due a 4% to 8% royalty from GSK, tiered upon global sales, for each of the aforementioned programs.
Second Quarter Financial Results
•Cash, cash equivalents and investments totaled $392.2 million as of June 30, 2020 compared to $428.5 million as of December 31, 2019, for a decrease of $36.3 million. The decrease relates primarily to cash used for operating activities.
•Collaboration revenue was zero and $15.0 million for the three and six months ended June,30 2020, which related to milestone payments for successful BLA and MAA filings for dostarlimab by GSK, compared to $5 million for both the three and six months ended June 30, 2019.
•Research and development expenses were $17.9 million and $38.9 million for the three and six months ended June 30, 2020, compared to $27.4 million and $48.0 million for the three and six months ended June 30, 2019. The decrease was due primarily to reduced outside services for manufacturing expenses based on the timing of projects.
•General and administrative expenses were $4.7 million and $9.0 million for the three and six months ended June 30, 2020, compared to $4.3 million and $8.4 million for the three and six months ended June 30, 2019. The increase was due primarily to increased legal and insurance expenses.
•Net loss was $21.5 million and $29.8 million for the three and six months ended June 30, 2020, or a net loss per share of $0.79 and $1.09, compared to a net loss of $24.0 million and $46.0 million for the three and six months ended June 30, 2019, or a net loss per share of $0.89 and $1.70.
Financial Guidance
AnaptysBio expects its net cash burn in 2020 will be approximately $60.0 million, and that its cash, cash equivalents and investments will fund its current operating plan at least into 2023.

On August 10, 2020 OncoSec Medical Incorporated (NASDAQ: ONCS) (the "Company" or "OncoSec"), a company developing late-stage intratumoral cancer immunotherapies, reported that Daniel J. O’Connor, President and Chief Executive Officer will present at the BTIG Virtual Biotechnology Conference 2020 on Tuesday, August 11, 2020 (Press release, OncoSec Medical, AUG 10, 2020, View Source [SID1234563288]).

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The OncoSec presentation will begin at 12:30 PM ET and will available via webcast at View Source

In addition, the Company will be available for virtual one-on-one meetings on August 10th and 11th. Interested parties should register for the conference via View Source

On August 10, 2020 Aeglea BioTherapeutics, Inc. (NASDAQ:AGLE), a clinical-stage biotechnology company developing a new generation of human enzyme therapeutics as innovative solutions for rare and other high-burden diseases, reported its second quarter 2020 financial results, and provided recent corporate and program highlights (Press release, Aeglea BioTherapeutics, AUG 10, 2020, View Source [SID1234563287]).

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"Despite the operating challenges posed by the global pandemic, we continued to advance our pegzilarginase program in the first half of the year. The presentation of long-term data showing sustained lowering of arginine levels and durable clinical response with pegzilarginase treatment, as well as progress in our patient identification efforts, reinforce our belief in its potential as a life-changing therapy for those with Arginase 1 Deficiency and lay a strong foundation for the commercial launch of pegzilarginase," said Anthony Quinn, M.B Ch.B, Ph.D., president and chief executive officer of Aeglea. "Additionally, we initiated our Phase 1/2 clinical trial of ACN00177 for Homocystinuria in the second quarter. We are continuing our patient identification activities and look forward to dosing the first patient once the clinical sites are able to begin screening patients."

Recent Highlights and Updates

Pegzilarginase in Arginase 1 Deficiency

In May, Aeglea presented results from its 56 week analysis from the Company’s completed Phase 1/2 clinical trial and ongoing open-label extension study during a late-breaking oral presentation at the 6th Congress of the European Academy of Neurology. Key results include:
Treatment with pegzilarginase resulted in a significant reduction in plasma arginine from baseline with all 13 patients achieving plasma arginine levels within the target range (<200 µM).
85% (11 of 13) of patients were clinical responders based on mobility improvements evaluated using three assessments: 6MWT (6 Minute Walk Test), GMFM (Gross Motor Function) Part D (standing) and Part E (walking, running, and jumping).
Pegzilarginase was shown to have a favorable safety profile with more than 750 doses administered.
To date, Aeglea has identified more than 240 Arginase 1 Deficiency patients. The number of identified patients represents more than 50% and 30% of the estimated genetic prevalence patient population in the U.S. and key European markets (France, Germany, Spain, Italy and the United Kingdom), respectively.
ACN00177 in Homocystinuria

Aeglea initiated its Phase 1/2 clinical trial for ACN00177, a novel engineered human enzyme therapy designed to treat Homocystinuria, a serious metabolic disorder characterized by elevated plasma homocysteine which leads to a wide range of life-altering complications and reduced life expectancy.
Corporate

Eric Bradford, M.D., M.Sc., M.B.A. has been promoted to Chief Development Officer. Dr. Bradford will oversee the clinical programs for pegzilarginase and ACN00177 as well as shape the clinical development strategy for future programs from the Company’s platform of novel human enzymes.
Chief Medical Officer Ravi M. Rao, M.B BChir, Ph.D., will depart the company to pursue other opportunities. Dr. Rao will continue to support Aeglea in a medical advisor role through a transitional period.
"Ravi has been a valued and impactful member of the Aeglea team. While we are disappointed by his planned departure, we wish him the best as he returns to his roots in immunology research and development," said Dr. Quinn. "I look forward to working more closely with Eric as we continue to strengthen our capabilities and advance pegzilarginase towards potential approval and launch."

Upcoming Events
Aeglea will be attending the following virtual investor conferences in the coming quarter.

Wells Fargo Securities Healthcare Conference, September 9-10
H.C. Wainwright Healthcare Conference, September 13-15
Cantor Fitzgerald Global Healthcare Conference, September 15-17
Further, Aeglea’s leadership looks forward to participating in dialogue about the Company’s enzyme therapeutics platform during the following industry events, with additional details to be announced.

World Orphan Drug Congress USA 2020, August 24-26
Child Neurology Society Annual Meeting-International Child Neurology Congress 2020, October 19-23
Second Quarter 2020 Financial Results

As of June 30, 2020, Aeglea had available cash, cash equivalents, marketable securities and restricted cash of $159.2 million. Based on Aeglea’s current operating plans, management believes it has sufficient capital resources to fund anticipated operations through 2022.

Research and development expenses totaled $16.9 million for the second quarter of 2020 and $14.8 million for the second quarter of 2019. The increase was primarily associated with investing in manufacturing and pre-commercial activities for Aeglea’s lead product candidate, pegzilarginase; ramp-up in manufacturing activities for ACN00177 in Homocystinuria; and personnel-related expenses offset by decreasing clinical development expenses as a result of completing a Phase 1/2 clinical trial in patients with Arginase 1 Deficiency and closing out cancer trials.

General and administrative expenses totaled $4.7 million for the second quarter of 2020 and $3.8 million for the second quarter of 2019. This increase was primarily due to additional employee headcount, ramping up commercial capabilities, and additional facilities to support company growth.

Net loss totaled $21.4 million and $18.0 million for the second quarter of 2020 and 2019, respectively, with non-cash stock compensation expense of $1.6 million and $1.2 million for the second quarter of 2020 and 2019, respectively.

About Pegzilarginase in Arginase 1 Deficiency

Pegzilarginase is an enhanced human arginase that enzymatically lowers levels of the amino acid arginine. Aeglea is developing pegzilarginase for the treatment of patients with Arginase 1 Deficiency (ARG1-D), a rare debilitating, progressive disease presenting in childhood with persistent hyperargininemia, spasticity, developmental delay, intellectual disability, seizures and early mortality. Pegzilarginase is intended for use as an enzyme therapy to reduce elevated blood arginine levels in patients with ARG1-D. Aeglea’s Phase 1/2 and Phase 2 open-label extension data for pegzilarginase in patients with ARG1-D demonstrated clinical improvements and sustained lowering of plasma arginine. The Company’s single, global pivotal Phase 3 PEACE trial is designed to assess the effects of treatment with pegzilarginase versus placebo over 24 weeks with a primary endpoint of plasma arginine reduction.

About ACN00177 in Homocystinuria

Aeglea is developing ACN00177 for the treatment of patients with cystathionine beta synthase (CBS) deficiency, also known as Classical Homocystinuria. Homocysteine accumulation plays a key role in multiple progressive and serious disease-related complications, including thromboembolic vascular events, skeletal abnormalities including severe osteoporosis, developmental delay, intellectual disability, lens dislocation and severe near-sightedness. ACN00177 has been designed as a novel recombinant human enzyme, which degrades the amino acid homocysteine and its related homocystine dimer. With this mechanism, ACN00177 is intended to lower the abnormally high blood levels of homocysteine in patients with Homocystinuria. Preclinical data demonstrated that ACN00177 improved important disease-related abnormalities and survival in a mouse model of Homocystinuria. The Company initiated a Phase 1/2 trial in the second quarter of 2020 and continues patient identification and administrative activities. The timing of first patient dosing in this Phase 1/2 trial will depend on determinations by individual sites as they adjust to impacts from COVID-19.

On August 10, 2020 Rubius Therapeutics, Inc. (Nasdaq:RUBY), a clinical-stage biopharmaceutical company that is genetically engineering red blood cells to create an entirely new class of cellular medicines, reported second quarter 2020 financial results and provided an overview of operational progress (Press release, Rubius Therapeutics, AUG 10, 2020, View Source [SID1234563286]).

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"Rubius Therapeutics is making excellent progress in advancing our pipeline of Red Cell Therapeutics, including the completion of dosing of the second cohort in the RTX-240 Phase 1/2 solid tumor clinical trial with no observed adverse events to date attributed to RTX-240. As we enter the higher-level dose cohorts, we expect to see the biological effects of RTX-240 on innate and adaptive immunity, including activation and increased numbers of NK cells and T cells. We are continuing to leverage virtual capabilities to engage our clinical trial sites with a concentration on oncology-focused centers, which have been less impacted than hospitals by the ongoing pandemic. Ensuring patient, clinician and employee safety remains our top priority," said Pablo J. Cagnoni, M.D., chief executive officer of Rubius Therapeutics. "During the second quarter, we presented preclinical data supporting our lead artificial antigen-presenting cell program, RTX-321, at the American Association of Cancer Research and American Society of Gene and Cell Therapy Virtual Annual Meetings. Taken together, these data suggest that RTX-321 may lead to durable responses in patients with HPV 16-positive cancers. We are on track to file an Investigational New Drug application for RTX-321 for the treatment of HPV-positive cancers by year-end."

Second Quarter Highlights and Upcoming Milestones

·Dosing of the first two cohorts completed in the Phase 1/2 solid tumor clinical trial with no adverse events observed to date that were attributed to RTX-240.

oAs Rubius enters higher-level dose cohorts, it expects to see the biological effects of RTX-240 on innate and adaptive immunity, including activation and increased numbers of NK cells and T cells.

The Company continues to leverage virtual capabilities to engage clinical trial sites and is concentrating on oncology-focused centers to enroll patients during the pandemic, while ensuring that patient and clinician safety is a top priority.

oRubius’ fully owned manufacturing facility in Smithfield, RI, continues to successfully manufacture clinical supply of RTX-240.

·Rubius highlighted preclinical data for RTX-321 at the American Association of Cancer Research (AACR) (Free AACR Whitepaper) Virtual Annual Meeting II and the American Society of Gene and Cell Therapy (ASGCT) (Free ASGCT Whitepaper) 23rd Annual Meeting, supporting its lead artificial antigen-presenting cell program, RTX-321, for the treatment of HPV 16-positive tumors.

oAt AACR (Free AACR Whitepaper), the preclinical data suggested that RTX-321 may promote epitope spreading, meaning that RTX-321 may induce the expansion of an immune response to secondary epitopes, or antigens, that are not expressed on RTX-321. This finding is important because it suggests that RTX-321 may create a broad and effective immune response against multiple tumor antigens. Additionally, the preclinical surrogate of RTX-321 induced tumor-specific memory, potentially enabling the body to remember a cancer’s identity, which is critical to providing long-term protection from recurrence of the tumor.

oAt ASGCT (Free ASGCT Whitepaper), preclinical in vitro data demonstrated that RTX-321 can expand the different cell populations – effector and long-lived memory CD8+ cells – that are critical for delivering and maintaining long-term, anti-tumor responses in patients.

Second Quarter Financial Results

Net loss for the second quarter of 2020 was $37.9 million or $0.47 per common share, compared to $39.4 million or $0.50 per common share in the second quarter of 2019.

In the second quarter of 2020, Rubius invested $26.1 million in research and development (R&D) related to its novel RED PLATFORM and towards expanding and advancing its product pipeline, as compared to $27.5 million in the second quarter of 2019. The year-over-year decrease was driven by a $7.0 million reduction in costs following the deprioritization of our rare disease pipeline in March 2020. The decrease in rare disease program expenses was offset by $8.8 million in incremental spend to advance our cancer programs, including costs associated with our Phase 1/2 clinical trial for RTX-240 for the treatment of solid tumors as well as costs associated with preclinical and IND-enabling activities for RTX-321. In addition, R&D expenses not allocated to programs decreased by $3.2 million driven by a $2.2 million reduction in laboratory supplies, research materials and contract research as pilot-scale manufacturing and discovery activities shifted to support clinical programs. Other costs not allocated to programs also decreased resulting primarily from a decrease in stock-based compensation expense.

G&A expenses were $11.6 million during the second quarter of 2020, as compared to $13.8 million for the second quarter of 2019. The lower costs were principally driven by a reduction in stock-based compensation expense.

Six Month Financial Results

Net loss for the first six months of 2020 was $86.3 million or $1.07 per common share, compared to $72.0 million or $0.92 per common share in the first six months of 2019.

In the six months ended June 30, 2020, Rubius invested $62.3 million in R&D related to its novel RED PLATFORM and towards expanding and advancing its product pipeline, as compared to $48.4 million in the first six months of 2019. The year-over-year increase was driven by $18.7 million of incremental costs to advance our cancer programs, including costs incurred for our Phase 1/2 clinical trial for RTX-240 for the treatment of solid tumors as well as costs of preclinical and IND-enabling activities for RTX-321. The increase in cancer program costs was offset by a $5.3 million decrease in expenses related to our rare disease pipeline following the deprioritization of these programs in March 2020. Additionally, costs not allocated to programs increased by $0.5 million, primarily driven by R&D headcount growth.

G&A expenses were $24.3 million during the first six months of 2020, as compared to $27.3 million for the same period in 2019. The lower costs were principally driven by a reduction in stock-based compensation expense.

Cash Position

As of June 30, 2020, cash, cash equivalents and investments were $236.5 million as compared to $283.3 million as of December 31, 2019, providing Rubius with a cash runway into 2022. During 2020, the Company used $68.6 million of cash to fund operations and $3.9 million to fund capital expenditures, consisting mostly of payments for assets purchased in 2019. In addition, during the second quarter, the Company drew down the third and final tranche of $25.0 million pursuant to its $75.0 million loan agreement with Solar Capital.