On August 12, 2020 Beam Therapeutics Inc. (Nasdaq: BEAM), a biotechnology company developing precision genetic medicines through base editing reported pipeline updates, recent business highlights and second quarter 2020 financial results (Press release, Beam Therapeutics, AUG 12, 2020, View Source [SID1234563482]).

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"Throughout the first half of 2020, we made significant progress across all aspects of our business, culminating into naming the first two base editing development candidates from our portfolio. As we move closer to the clinic, we have also made the important strategic decision to establish a build-to-suit manufacturing facility, which will significantly enhance our capability to manufacture a wide range of base editing medicines," said John Evans, chief executive officer of Beam. "In addition, we continue to execute our strategy of establishing innovative partnerships to access new capabilities and to accelerate the development of base editors as a new class of precision genetic medicines for patients. Amidst the evolving COVID-19 situation, our team is performing well, and we remain on track to initiate IND-enabling studies in 2020 and file at least one Investigational New Drug application in 2021."

Giuseppe Ciaramella, Ph.D., president and chief scientific officer of Beam added, "Achieving our first development candidates with base editing is one of the most important milestones for our company yet. BEAM-101 and BEAM-102 are highly differentiated editing programs that may enable a one-time treatment option for patients with sickle cell disease. Both candidates are supported by promising preclinical data, and we are working to advance them to the next stage of development to assess the impact they could have in treating this devastating disease."

Base Editing Progress

First Base Editing Development Candidates Named for Treatment of Sickle Cell Disease: Beam is pursuing two differentiated base editing approaches to treat hemoglobinopathies and recently named the first two development candidates from its portfolio. Promising preclinical data from these two complementary editing programs were presented at the 23rd American Society of Gene and Cell Therapy (ASGCT) (Free ASGCT Whitepaper) Virtual Annual Meeting.
BEAM-101 is an adenine base editor (ABE) that reproduces single base changes observed in individuals with hereditary persistence of fetal hemoglobin, or HPFH, in which elevated levels of fetal hemoglobin protect these individuals from the effects of sickle cell disease or beta-thalassemia.

BEAM-102 is an ABE that directly corrects the causative mutation in sickle cell disease, converting it into a naturally-occurring human hemoglobin variant, Hb-G Makassar. Individuals with the Makassar variant have normal hematologic parameters and no evidence of hemoglobin polymerization or sickling of red blood cells.

Preclinical Non-Human Primate Data Validating Beam’s ABE Technology Presented by Verve Therapeutics: Verve Therapeutics presented preclinical proof-of-concept data in non-human primates, utilizing ABE technology licensed from Beam, that demonstrate the successful use of base editing to turn off a gene in the liver and thereby lower blood levels of either LDL cholesterol or triglyceride-rich lipoproteins. Beam and Verve previously announced a strategic collaboration, under which Verve has exclusive access to Beam’s base editing, gene editing and delivery technologies for human therapeutic applications against certain cardiovascular targets. After the completion of Phase 1 studies, Beam has the ability to participate in future development and commercialization, and share 50 percent of U.S. profits and losses, for any product directed against these targets.
Recent Business Highlights

Lease Agreement for Beam’s In-House Manufacturing Facility to Support Future Product Development: On August 11, 2020, Beam entered into a lease agreement with Alexandria Real Estate Equities, Inc. to build a 100,000 square foot current Good Manufacturing Practice (cGMP) compliant manufacturing facility in Research Triangle Park, North Carolina that will support a broad range of clinical programs. Beam will invest up to $83 million over a five-year period and anticipates that the facility will be operational by the first quarter of 2023. The project will be facilitated, in part, by a Job Development Investment Grant (JDIG) approved by the North Carolina Economic Investment Committee, which authorizes potential reimbursements to Beam based on new tax revenues generated through the project. The facility will be designed to support manufacturing for the company’s ex vivo cell therapy programs in hematology and oncology and in vivo non-viral delivery programs for liver diseases, with flexibility to support manufacturing of its viral delivery programs, and ultimately, scale-up to support potential commercial supply.

Collaboration Established with Magenta Therapeutics to Evaluate MGTA-117 as a Conditioning Regimen for Base Editing Therapies: In June 2020, Beam and Magenta Therapeutics announced a non-exclusive research and clinical collaboration agreement to evaluate the potential utility of MGTA-117, Magenta’s targeted antibody-drug conjugate, for conditioning of patients with sickle cell disease and beta-thalassemia receiving Beam’s base editing therapies.

Strategic Alliance with Boston Children’s Hospital to Accelerate Translational and Clinical Research in Gene Editing for Complex Conditions: Beam has entered into a strategic alliance agreement with Boston Children’s Hospital designed to facilitate the development of disease-specific therapies using Beam’s base editing technology. Under the terms of the agreement, Beam will sponsor multiple research programs at Boston Children’s Hospital to advance translation of Beam’s pipeline across certain therapeutic areas of interest, including programs in sickle cell disease and pediatric leukemias and exploration of new disease areas. Boston Children’s Hospital will also serve as a clinical site in the future to advance bench-to-bedside translation of Beam’s pipeline.

Research Collaboration Established with Institute of Molecular and Clinical Ophthalmology Basel (IOB) to Develop Gene Editing Programs for Ocular Diseases: Beam has established a research collaboration agreement with the IOB, under which the partners will leverage IOB’s expertise in the field of ophthalmology and Beam’s base editing technology to advance programs directed to the treatment of certain ocular diseases, including Stargardt disease. Through this collaboration, IOB will leverage insights from ProgStar, an international collaboration studying the natural history study of Stargardt disease progression and helping to determine clinical outcome measures that could be used in clinical trials of future therapies. Additionally, IOB has developed technology that images the retina and choroid with better quality and dimension, as well as living models of the retina, which can be used to study the therapeutic impact base editing could have on ocular diseases.
Second Quarter 2020 Financial Results

Cash Position: Cash, cash equivalents and marketable securities were $228.0 million as of June 30, 2020.

Research & Development (R&D) Expenses: R&D expenses were $19.4 million for the quarter ended June 30, 2020, compared to $12.7 million for the quarter ended June 30, 2019. This increase was primarily due to the growth in the number of research and development employees and their related activities, as well as the expense allocated to R&D related to Beam’s leased facilities.

General &Administrative (G&A) Expenses: G&A expenses were $6.9 million for the quarter ended June 30, 2020, compared to $5.0 million for the quarter ended June 30, 2019. This increase was primarily a result of increased personnel related costs due to an increase in general and administrative employees and the cost of being a public company.

Net Loss: Net loss attributable to common stockholders was $34.2 million, or $0.69 per share, for the quarter ended June 30, 2020, compared to $21.1 million for the quarter ended June 30, 2019.

On August 12, 2020 TCR2 Therapeutics Inc. (Nasdaq: TCRR), a clinical-stage immunotherapy company with a pipeline of novel T cell therapies for patients suffering from cancer, reported financial results for the second quarter ended June 30, 2020 and provided a corporate update (Press release, TCR2 Therapeutics, AUG 12, 2020, View Source [SID1234563481]).

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"The second quarter was incredibly strong for the Company as we continued to deliver significant progress in our clinical trials of TC-210 and TC-110 despite the pandemic. We are particularly pleased to update that, following the earlier announcement of five of our first five cancer patients showing tumor regression with TC-210, one patient is now a confirmed partial response based on independent central review and experienced further tumor regression from 42% to 75%," said Garry Menzel, Ph.D., President and Chief Executive Officer of TCR2 Therapeutics. "The initial data from TC-210 provide meaningful readthrough for our TRuC-T cell platform and we believe our robust preclinical pipeline supports our next phase of growth as we build a leading cell therapy company treating solid tumors. The strengthening of our balance sheet through our recent financing puts us in an excellent position to execute on our objectives and provide further clinical and scientific updates in 2020."

Recent Developments

TCR2 announced positive interim data from the first five patients treated in the Phase 1 portion of the TC-210 Phase 1/2 clinical trial for mesothelin-expressing solid tumors. All five patients showed tumor regression including two with RECIST partial response, one of which is now confirmed and two patients with stable disease through six months. Translational data further demonstrated TRuC-T cell expansion and activation. A manageable toxicity profile was observed with only one patient exhibiting TC-210-related non-hematologic grade >2 toxicity and no evidence of neurotoxicity or on-target, off-tumor toxicity.
TCR2 highlighted preclinical data at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Virtual Annual Meeting II of the Company’s proprietary T Cell Receptor Fusion Construct (TRuC) T cells that co-express a PD-1:CD28 switch receptor, which acts as a cell-intrinsic mechanism to overcome PD-L1/PD-L2 mediated immunosuppression. Upon repeated antigen stimulation, co-expression of the switch receptor in mesothelin-targeting TC-210 T cells enhanced TCR downstream signaling, prevented PD-L1-mediatied functional T-cell inhibition, significantly increased proliferation and augmented the production of growth and effector cytokines.
TCR2 announced the expansion of its leadership team with key business development and regulatory affairs cell therapy experts with the appointments of Gregg McConnell as Head of Business Development and Viera Muzithras as Vice President of Regulatory Affairs.
Anticipated Milestones

TCR2 anticipates an interim update from the Phase 1 portion of the TC-210 Phase 1/2 clinical trial for patients with mesothelin-expressing solid tumors in 2H20.
TCR2 anticipates an interim update from the Phase 1 portion of the TC-110 Phase 1/2 clinical trial for patients with CD19+ non-Hodgkin lymphoma or adult acute lymphoblastic leukemia in 2H20.
TCR2 anticipates certification of its manufacturing facility in Stevenage, UK, in 2H20.
TCR2 anticipates an IND filing for a third TRuC-T cell program in 2021.
Financial Highlights

Cash Position: TCR2 ended the second quarter of 2020 with $124.8 million in cash, cash equivalents, and investments compared to $158.1 million as of December 31, 2019. As a result of the recent equity offering, TCR2 raised an additional $134.6 million. Net cash used in operations was $16.0 million for the second quarter of 2020 compared to $10.2 million for second quarter of 2019. TCR2 continues to project net cash use of $60-70 million for 2020.

R&D Expenses: Research and development expenses were $12.9 million for the second quarter of 2020 compared to $8.8 million for the second quarter of 2019. The increase in R&D expenses is primarily related to increase in headcount, activities related to the Phase 1/2 clinical trial of TC-210 and activities related to the Phase 1/2 clinical trial of TC-110.

G&A Expenses: General and administrative expenses were $3.8 million for the second quarter of 2020 compared to $3.3 million for the second quarter of 2019. The increase in general and administrative expenses was primarily due to an increase in personnel costs and costs associated with operations as a public company.

Net Loss: Net loss was $16.2 million for the second quarter of 2020 compared to $11.1 million for the second quarter of 2019, driven predominantly by increased R&D expenses.
Upcoming Events

TCR2 Therapeutics management is scheduled to participate at the following upcoming conferences.

2020 Wedbush PacGrow Healthcare Virtual Conference: Ian Somaiya, Chief Financial Officer of TCR2 Therapeutics, will provide a company update using a virtual platform on Wednesday, August 12, 2020 at 10:55am ET
Cantor Fitzgerald Virtual Global Healthcare Conference: Garry Menzel, Ph.D., President and Chief Executive Officer of TCR2 Therapeutics, and Ian Somaiya, Chief Financial Officer of TCR2 Therapeutics, will provide a company update using a virtual platform on Wednesday, September 16, 2020 at 8:40am ET

On August 12, 2020 Vaccibody AS and Nektar Therapeutics (NASDAQ: NKTR) reported that the first patient has been dosed in the combination therapy of the Phase 1/2a study evaluating bempegaldesleukin (bempeg), Nektar’s CD122-preferential IL-2 pathway agonist, with VB10.NEO, Vaccibody’s personalized neoantigen cancer vaccine, in patients with advanced squamous cell carcinoma of the head and neck (SCCHN) (Press release, Vaccibody, AUG 12, 2020, View Source [SID1234563480]).

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"We’re pleased to advance our collaboration with Vaccibody to evaluate the potential of bempeg given with a personalized vaccine, VB10.NEO, in patients with advanced head and neck cancer," said Jonathan Zalevsky, Ph.D., Chief Research & Development Officer at Nektar. "The rationale for this clinical study is supported by our promising preclinical data which demonstrated how a personalized cancer vaccine and a T cell proliferator can work synergistically to induce maximal expansion of vaccine-induced T cell clones, provide deep and durable responses and, at the same time, offer specific anti-tumor immunity."

VB10.NEO is designed to specifically activate a patient’s immune system to tumor-specific antigens, called neoantigens, while bempeg is designed to expand and proliferate tumor antigen-specific T cells in the periphery and in the tumor microenvironment. Addition of bempeg to VB10.NEO is intended to drive maximal expansion of vaccine-induced neoantigen-specific T cells for the treatment of cancer.

At the 2019 Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting, Vaccibody presented interim data for VB10.NEO in a group of patients with various solid tumor types who had all received multiple lines of prior anti-cancer therapy and had been treated with at least one checkpoint inhibitor (CPI) (nivolumab or pembrolizumab) for a range of 5 to 32 months. The data presented showed that 50 percent (7/14) of patients treated with VB10.NEO achieved clinical responses, including four patients with SCCHN. Clinical response was defined as either >10% reduction in the target lesions (as identified at screening) or converting progressive lesions into stable lesions (<20% increase, up to 37 weeks follow-up).

"We are pleased that our initial data with VB10.NEO demonstrated that the vaccine induced strong neoantigen-specific T cell responses and clinical benefit, particularly in patients who did not respond to checkpoint inhibitor monotherapy," said Agnete Fredriksen, President and Chief Scientific Officer of Vaccibody and continued: "We believe combining bempeg, a T cell stimulator, with VB10.NEO can further drive the expansion of VB10.NEO elicited neoantigen-specific T cells and potentially deepen and broaden anti-tumor activity. Siri Torhaug, Chief Medical Officer of Vaccibody added, "We are happy to announce the first patient dosed with the combined therapy of VB10.NEO and bempegaldesleukin and look forward to seeing the first read outs from this unique approach in patients with head and neck cancer."

Preclinical studies evaluating the combination of VB10.NEO and bempeg demonstrated the synergy of the two mechanisms to elicit greater breadth and depth of neoantigen-specific T cell responses as compared to each agent individually. In preclinical models of solid tumors, the combination induced strong immunogenic CD8+ T cell responses, and when combined with anti-PD-1, induced rapid, complete and durable tumor regression of small tumors, and long-lasting disease control of large tumors.1

About VB10.NEO
VB10.NEO, is Vaccibody’s proprietary therapeutic DNA vaccine which uses the patient’s own neoantigens for the personalized treatment of cancer patients. A phase 1/2a neoantigen clinical trial is currently enrolling patients with locally advanced or metastatic melanoma, non-small cell lung carcinoma, clear renal cell carcinoma as well as urothelial cancer or squamous cell carcinoma of the head and neck. In clinical trials, VB10.NEO has demonstrated induction of strong neoantigen-specific immune responses which led to clinical responses in patients with locally advanced or metastatic disease.

About Bempegaldesleukin (NKTR-214)
Bempegaldesleukin is designed to stimulate cancer-killing immune cells in the body by targeting CD122 receptors found on the surface of these immune cells. CD122, which is also known as the Interleukin-2 receptor beta subunit, is a key signaling receptor that is known to increase proliferation of these effector T cells.2 In clinical and preclinical studies, treatment with bempegaldesleukin resulted in expansion of these cells and mobilization into the tumor micro-environment.3,4

On August 12, 2020 IDEAYA Biosciences, Inc. (Nasdaq: IDYA), an oncology-focused precision medicine company committed to the discovery and development of targeted therapeutics, reported financial results for the second quarter ended June 30, 2020 (Press release, Ideaya Biosciences, AUG 12, 2020, View Source [SID1234563479]).

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"This quarter was transformational for IDEAYA. We have cash runway into 2024, with quarter-end cash, cash equivalents and marketable securities of $172.0 million supplemented by $127.5 million aggregate gross proceeds received subsequently, including $100 million non-dilutive upfront cash and $20 million private placement equity investment from GSK. In addition, through our GSK strategic partnership and our Pfizer collaboration and supply agreement, we have established an attractive cost structure and retained significant future upside across our pipeline, while also creating opportunities for non-dilutive cash milestones of approximately $3 billion across three programs with GSK. We also nominated MAT2A development candidate IDE397, initiated the IDE196 and binimetinib Phase 1 combination, and met the criteria for IDE196 Phase 2 expansion in skin melanoma. As we celebrate our five-year anniversary, we have built a strong foundation to create the industry leading Synthetic Lethality-focused precision medicine oncology company," said Yujiro S. Hata, Chief Executive Officer and President of IDEAYA Biosciences.

GlaxoSmithKline Strategic Partnership

IDEAYA and GSK entered into a strategic partnership in Synthetic Lethality focused on IDEAYA’s MAT2A, Pol Theta, and Werner Helicase programs – each of which has a strong rationale for collaborating, including potential clinical combinations with GSK precision medicine therapeutics. The strategic partnership includes small molecule and protein degrader modalities.

IDEAYA retains all rights and interests in its other pipeline assets, including preclinical programs targeting PARG and a proprietary DNA Damage Target, as well as its clinical candidate IDE196 for patients having tumors harboring GNAQ or GNA11 hotspot mutations.

Program Updates

Key highlights for IDEAYA’s pipeline programs include:

MAT2A

IDEAYA’s lead synthetic lethality research program targets MAT2A for solid tumors with MTAP deletions, a patient population estimated to represent approximately 15% of solid tumors. IDEAYA continues to lead research and development on the MAT2A program through early clinical development. Subject to exercise of its option, GSK will lead later stage global clinical development. Highlights:

Designated MAT2A inhibitor IDE397 as a development candidate;
Demonstrated IDE397 in vivo dose-dependent efficacy and tumor regression (with >100% TGI, or tumor growth inhibition) as monotherapy in an endogenous non-small cell lung cancer MTAP-null PDX model;
Initiated good laboratory practice (GLP)-compliant toxicology studies with IDE397 in two species;
On track for IND submission to the FDA for IDE397 in the fourth quarter of 2020, subject to satisfactory completion of GLP toxicology studies;
Plan to initiate a Phase 1 clinical trial for clinical evaluation of IDE397 as monotherapy in the first half of 2021, subject to effectiveness of the IND; and
IDEAYA and GSK are evaluating a potential phase 1 combination clinical trial for IDEAYA’s MAT2A inhibitor (IDE397) and GSK’s Type I PRMT inhibitor (GSK3368715).
PARG

IDEAYA is advancing preclinical research for an inhibitor of poly (ADP-ribose) glycohydrolase, or PARG. PARG inhibitors have shown synthetic lethality with tumors harboring BRCA2 mutations, impaired base excision repair, or BER, and potentially other genetic and/or molecular signatures. Highlights:

Demonstrated in vivo proof of concept in a relevant animal model having a replication stress genetic signature;
Validating a potential synthetic lethality biomarker for identifying tumor cells having sensitivity to a PARG inhibitor;
Observed monotherapy PARG inhibitor in vivo efficacy in multiple PDX models, including tumor regression; and
Targeting to identify a PARG inhibitor development candidate in 2021
Pol Theta

IDEAYA’s Pol Theta program targets tumors with BRCA or other homologous recombination deficiency (HRD) mutations. IDEAYA and GSK will collaborate on ongoing preclinical research, including small molecules and protein degraders, and GSK will lead clinical development for the Pol Theta program. Subject to such preclinical studies, we are targeting to file an IND for a Pol Theta inhibitor in 2021. Highlights:

Demonstrated in vivo efficacy with tumor regression in BRCA2 -/- xenograft model with IDEAYA Pol Theta inhibitor in combination with niraparib, a GSK PARP inhibitor
Werner Helicase

IDEAYA is advancing preclinical research for an inhibitor targeting Werner Helicase for tumors with high microsatellite instability (MSI). IDEAYA and GSK will collaborate on ongoing preclinical research, and GSK will lead clinical development for the Werner Helicase program.

Expanding Synthetic Lethality Pipeline and Synthetic Lethality Platform

IDEAYA has initiated additional preclinical synthetic lethality research programs, including for a DNA Damage Target (DDT), for patients with solid tumors characterized by a proprietary biomarker or gene signature.

IDEAYA continues to build its Synthetic Lethality platform, investing in target identification, biomarker discovery and drug discovery, including small molecules and protein degraders, to create the industry leading Synthetic Lethality and DNA Damage based pipeline.

IDE196

IDEAYA continued to execute on its clinical trial, initiated in June 2019, to evaluate IDE196 in Metastatic Uveal Melanoma (MUM) and Non-MUM solid tumors harboring activating GNAQ/11 mutations. The clinical development strategy for IDE196 is focused on evaluating IDE196 combination therapy for the MUM indication, and evaluating IDE196 monotherapy in non-MUM GNAQ/11 hotspot mutation solid tumors, such as skin melanoma.

Combination Therapy

IDEAYA is enrolling MUM patients into a combination arm of the IDE196 Phase 1/2 clinical trial to evaluate safety and efficacy of IDE196 in combination with binimetinib, a MEK inhibitor. We may also evaluate IDE196 / binimetinib combination therapy in patients having other solid tumors with activating GNAQ/11 hotspot mutations, such as skin melanoma. The combination arm is being conducted under a clinical trial collaboration and supply agreement with Pfizer Inc., pursuant to which Pfizer supplies us with their MEK inhibitor, binimetinib; the companies established a Joint Development Committee with Pfizer to facilitate combination arm drug supply, trial initiation and ongoing development. Highlights:

First-Patient-In (FPI) of a MUM patient for IDE196 / binimetinib combination arm of the IDE196 clinical trial in June 2020;
Initiated dosing into a first cohort of the IDE196 / binimetinib dose escalation portion of combination arm; and
Interim data from evaluation of IDE196 / binimetinib combination therapy anticipated in late 2021 to early 2022.
Monotherapy

IDEAYA is actively enrolling into the IDE196 monotherapy Phase 2 tissue-type agnostic basket arm in Non-MUM solid tumors having GNAQ or GNA11 hotspot mutations, including skin melanoma. Highlights:

Clinical protocol criteria met for cohort expansion in cutaneous melanoma, or skin melanoma. Of 4 evaluable skin melanoma patients harboring GNAQ/11 hotspot mutations (out of 5 total enrolled; excluding 1 non-evaluable), a 100% Disease Control Rate was observed, and one confirmed partial response (cPR) was determined by RECIST 1.1 guidelines;
The skin melanoma patient with cPR observed an initial partial response (-31.1%) at 8 weeks, which was sustained at 20 weeks (-37%) with reduction in target liver lesion and inguinal lymph node. Treatment with IDE196 is ongoing as of August 1, 2020;
Dosed first leiomyosarcoma patient in the Phase 2 GNAQ/11 basket arm, expanding the tissue-agnostic approach to additional solid tumors;
Established a relationship with CARIS through which we are accessing their network of clinical trial sites into which we can enroll qualifying patients having tumors harboring GNAQ/11 hotspot mutations; and
Interim data from the monotherapy arm of the Phase 2 basket trial anticipated in first half of 2021.
General

IDEAYA completed IDE196 tablet formulation and successfully introduced the tablet in the ongoing clinical trial, including the IDE196 / binimetinib combination arm and the GNAQ/11 basket arm.

IDEAYA completed 13-week GLP-compliant toxicology studies in two species, with receipt of submission-ready audited draft reports.

IDEAYA continues to monitor Covid-19 and its potential impact on clinical trials and timing of clinical data results. Covid-19 infection rates have increased recently in several states in which our clinical trial sites are located. As such, ongoing monitoring of enrolled patients, including obtaining patient computed tomography (CT) scans, may be impacted, and new patient enrollment into the Phase 2 expansion arm for IDE196 as a monotherapy in non-MUM solid tumors having GNAQ or GNA11 hotspot mutations may be delayed; the specific impacts are currently uncertain.

Corporate Updates

IDEAYA anticipates that existing cash, cash equivalents, and short-term and long-term marketable securities of $172.0 million as of June 30, 2020, together with the additional aggregate gross proceeds of $127.5 million received from GSK as up-front cash payment and from equity investments subsequent to June 30, 2020, will be sufficient to fund planned operations into 2024, and through potential achievement of multiple preclinical and clinical milestones across multiple programs.

Our updated corporate presentation is available on our website, in the Presentations section of our Investor Relations page. See: View Source .

Financial Results

As of June 30, 2020, IDEAYA had cash, cash equivalents, and short-term and long-term marketable securities totaling $172.0 million. This compared to cash, cash equivalents and short-term marketable securities of $100.5 million at December 31, 2019. The increase was primarily due to $93.6 million in net proceeds from IDEAYA’s follow-on public offering through June 30, 2020.

Research and development (R&D) expenses for the three months ended June 30, 2020 totaled $8.6 million compared to $8.9 million for the same period in 2019. The decrease was primarily due to a decrease in R&D headcount and laboratory supply costs, offset by an increase in costs related to our IDE196 clinical trial and the advancement of IDE397 through preclinical studies.

General and administrative (G&A) expenses for the three months ended June 30, 2020 totaled $4.0 million compared to $2.4 million for the same period in 2019. The increase was primarily due to an increase in G&A headcount costs, director and officer insurance policy premiums, costs related to our shelf registration statement filing on Form S-3, and an increase in legal expenses.

The net loss for the three months ended June 30, 2020 was $12.4 million compared to $10.7 million for the same period in 2019. Total stock compensation expense for the three months ended June 30, 2020 was $0.8 million compared to $0.5 million for the same period in 2019.

On August 12, 2020 Paragon Biosciences reported the appointment of Kerensa Jimenez as the new chief executive officer of its capital markets group, Paragon Health Capital (PHC), a registered broker-dealer (Press release, Paragon Biosciences, AUG 12, 2020, View Source [SID1234563478]). With deep experience and a proven track record, Ms. Jimenez will spearhead all financings, mergers and acquisitions (M&A) advisory services, and capital planning for Paragon Biosciences’ portfolio of innovative life science companies.

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"Since 2017, Paragon Biosciences and its partners have invested or committed to invest more than $1 billion to build life science companies, and we expect ongoing investment of up to $500 million per year," said Jeff Aronin, founder, chairman and chief executive officer of Paragon Biosciences. "We have had the privilege of working closely with Kerensa for many years and believe her M&A and capital markets expertise will further enhance our capabilities as we continue on our mission of solving complex human and societal challenges by accelerating development of novel therapies and life science breakthroughs."

Ms. Jimenez brings more than 15 years of experience advising clients on M&A and financing transactions. Prior to joining Paragon Health Capital, she served as managing director of Octagon Capital Group, a top-tier merchant bank that has led numerous transactions for Paragon portfolio companies over the past several years. Earlier in her career, Ms. Jimenez was a director at Farlie Turner, a middle market investment bank, where she provided M&A advisory services to private equity clients and business owners in the healthcare, consumer, energy, and business services sectors. She received a Bachelor of Science in economics from the University of Pennsylvania’s Wharton School.

"Paragon Biosciences has an incredibly unique model to support focused, visionary companies with the long-term capital they need to further life science innovations including novel biopharmaceuticals, artificial intelligence-enabled life science products, and cutting-edge cell and gene therapies," said Ms. Jimenez. "I look forward to leading this important organization to support Paragon’s rapid growth."