On November 10, 2020 Prelude Therapeutics Incorporated ("Prelude", "the Company", "we") (Nasdaq: PRLD), a clinical-stage precision oncology company, reported its financial results for the third quarter ended September 30, 2020 and provided an update on recent developments (Press release, Prelude Therapeutics, NOV 10, 2020, View Source [SID1234570506]).

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"Prelude has evolved substantially to become a clinical-stage precision oncology company with multiple small molecule oral agents currently advancing through clinical trials," said Kris Vaddi, PhD, Chief Executive Officer, Prelude Therapeutics. "We continue to make great progress in advancing the clinical development of our lead PRMT5 inhibitors, PRT543 and PRT811, and believe we are well-positioned for continued success with the execution of these programs. We look forward to sharing additional data from each program in 2021."

Dr. Vaddi added, "Beyond our PRMT5 program, we recently advanced our third product candidate, MCL1 inhibitor PRT1419, into the clinic for patients with hematologic malignancies, while our discovery engine continues to generate a diverse and robust pipeline. On the heels of our recent initial public offering resulting in gross proceeds of $181.9 million, we look forward to achieving additional clinical and regulatory milestones in the coming quarters."

Clinical Program Highlights

PRT543

Dose Expansion Portion of Phase 1 Trial to Commence by Year-End. The Company remains on track to commence the expansion portion of its Phase 1 trial of its lead product candidate, PRT543, which is designed to be a potent, selective, and oral inhibitor of PRMT5, in select solid tumor cohorts during the fourth quarter of 2020 and in select myeloid malignancy cohorts in early 2021. The expansion cohorts will include patients with adenoid cystic carcinoma (ACC), myelofibrosis (MF), genomically-selected myelodysplastic syndrome (MDS), and homologous recombination deficient positive (HRD+) tumors. Preliminary data from the dose escalation portion of the trial demonstrated early signs of clinical activity and tolerability, including a durable confirmed complete response (CR) in a patient with HRD+ high grade serous ovarian cancer who had received seven prior lines of therapy. The Company anticipates obtaining initial clinical data from these expansion cohorts in the first half of 2021 and presenting these data at medical meetings in 2021.
PRT811

Dose Escalation Ongoing in Phase 1 Trial in Patients with Advanced Solid Tumors and Recurrent High-Grade Gliomas. The dose escalation portion of the Company’s Phase 1 trial of its second clinical product candidate, PRT811, which is designed to be a potent, selective, and brain penetrant PRMT5 inhibitor, in patients with advanced solid tumors, including glioblastoma multiforme (GBM) and primary central nervous system lymphomas (PCNSL), remains ongoing. To date, the trial has demonstrated early signs of clinical activity and tolerability. The previously disclosed refractory GBM patient whose tumor had demonstrated a 66% reduction on monotherapy PRT811 has subsequently undergone a follow-up MRI at week 16 confirming a partial response (PR) per RANO (response assessment in neuro-oncology) criteria. The Company expects to commence the dose expansion portion of the trial in the first half of 2021, with data expected by the end of 2021.
PRT1419

Dosed First Patient in Phase 1 Trial of MCL1 Inhibitor PRT1419 for the Treatment of Relapsed/Refractory Hematologic Malignancies. In September 2020, Prelude announced dosing of the first patient in its first-in-human Phase 1 open-label, multicenter, dose-escalation study of PRT1419 in patients with relapsed/refractory hematologic malignancies. PRT1419, the Company’s third clinical candidate, is designed to be an orally available, potent, and selective MCL1 inhibitor.
Corporate Update

Completed Initial Public Offering (IPO). In September 2020, Prelude closed its IPO of 9,573,750 shares of common stock, including the full exercise of the underwriters’ option to purchase up to 1,248,750 additional shares of common stock, at a public offering price of $19.00 per share. Aggregate gross proceeds to Prelude were approximately $181.9 million, before deducting underwriting discounts and commissions and other offering expenses of $15.3 million.
Strengthened Board of Directors with Two New Appointments. In August 2020, the Company announced the appointment of Mardi C. Dier and Victor Sandor, M.D., both highly accomplished industry veterans, to its Board of Directors.
Third Quarter 2020 Financial Results

Cash and cash equivalents: Cash and cash equivalents as of September 30, 2020 were $234.8 million.
Research and Development (R&D) Expenses: For the third quarter of 2020, R&D expenses increased by $9.8 million to $15.3 million compared to $5.5 million for the third quarter of 2019. The increase was mainly due to increased clinical research costs for the PRT543 and PRT811 clinical trials and increased costs associated with the initiation of the clinical trial for PRT1419, which began in the third quarter of 2020. Prelude also incurred an increase in chemistry, manufacturing, and other costs for those trials.
General and Administrative (G&A) Expenses: For the third quarter of 2020, G&A expenses increased by $1.5 million to $2.9 million compared to $1.4 million for the third quarter of 2019. The increase was primarily due to an increase in personnel related expense due to increases in employee headcount and an increase in professional fees as Prelude expanded its operations to support its research and development efforts and incurred additional costs to operate as a public company.
Net Loss: For the third quarter of 2020, net loss was $16.8 million, or $5.25 per share, compared to a net loss of $6.7 million, or $3.93 per share, for the third quarter of 2019.

On November 10, 2020 Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL) reported that Raul Rodriguez, the company’s president and chief executive officer, is scheduled to present a company overview at the Jefferies Virtual London Healthcare Conference on Tuesday, November 17, 2020 at 12:00 p.m. Eastern Time (Press release, Rigel, NOV 10, 2020, View Source [SID1234570505]).

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To access the live and subsequently archived webcast, go to the Investor Relations section of the company’s website at www.rigel.com. Please connect to Rigel’s website several minutes prior to the start of the live webcast to ensure adequate time for any software download that may be necessary.

On November 10, 2020 Fusion Pharmaceuticals Inc. (Nasdaq: FUSN), a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines, reported financial results for the third quarter ended September 30, 2020 and provided an update on clinical and corporate developments (Press release, Fusion Pharma, NOV 10, 2020, View Source [SID1234570504]).

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"We are pleased with the results of the single-dose portion of our Phase 1 study of FPI-1434 that support our ability to move into the multi-dosing portion, and with trial sites now open, we continue to expect to dose our first patient in the fourth quarter," said Chief Executive Officer John Valliant, Ph.D. "Additionally, Fusion’s scalable platform can support a robust pipeline of next-generation radiopharmaceuticals using our precision medicine approach. We recently executed a collaboration agreement with AstraZeneca that allows us to retain commercial rights to our existing products while expanding our pipeline. We are well-positioned with the resources and robust manufacturing and supply chain capabilities to execute on our plans, grow our business and develop potent new cancer treatments for patients in need."

Recent Highlights and Future Milestones

Corporate Updates

On November 2, Fusion announced that the Company entered into a collaboration with AstraZeneca to develop and commercialize next-generation alpha-emitting radiopharmaceuticals and combination therapies for the treatment of cancer. The collaboration leverages Fusion’s Targeted Alpha Therapies (TATs) platform and expertise in radiopharmaceuticals with AstraZeneca’s leading portfolio of antibodies and cancer therapeutics, including DNA Damage Response Inhibitors (DDRis). Under the terms of the agreement, the companies will jointly discover, develop and commercialize novel TATs, which will utilize Fusion’s Fast-Clear linker technology platform with antibodies in AstraZeneca’s oncology portfolio. In addition, the companies will explore combination strategies between TATs (including Fusion’s lead candidate FPI-1434) and AstraZeneca therapeutics, for the treatment of various cancers. Both companies will retain full rights to their respective assets.
FPI-1434 Monotherapy

Fusion convened a Safety Review Committee (SRC) meeting in the third quarter of 2020 to evaluate the safety of the single-dose cohort of 40kBq/kg (cohort three). The SRC determined the safety data of cohort three allowed Fusion to begin the multi-dosing portion of the study at the next higher planned dose level. The Company expects to dose the first patient in the multi-dosing portion of the study in the fourth quarter of 2020, assuming no delays due to the spread of COVID-19.
The available safety, dosimetry, pharmacokinetic and biodistribution data from the single dose escalation portion of the study provided justification for the initiation of FPI-1434 multi-dosing at 75 kBq/kg. Both FPI-1434, and the imaging analogue FPI-1547, have been well tolerated. No dose limiting toxicities or serious adverse events related to study treatment were reported.
Fusion anticipates reporting Phase 1 multiple-dose safety and imaging data, and the recommended Phase 2 dose/schedule, approximately nine to eighteen months after commencing this portion of the study.
FPI-1434 Combination Therapy

Fusion has evaluated FPI-1434 in preclinical studies in combination with approved checkpoint and DNA damage response inhibitors, including PARP inhibitors, and believes the synergies observed could expand the addressable patient populations for FPI-1434 and allow for potential use in earlier lines of treatment.
Fusion anticipates the initiation of a Phase 1 combination study with FPI-1434 to occur six to nine months following determination of the recommended Phase 2 dose of FPI-1434 monotherapy.
FPI-1966

FPI-1966 is designed to target and deliver Actinium-225 to tumors expressing FGFR3, a protein that is overexpressed in head and neck and bladder cancers. Following the completion of pre-clinical studies, the Company expects to submit an IND for FPI-1966 in the first half of 2021.
Third Quarter 2020 Financial Results

Cash and Investments: As of September 30, 2020, Fusion held cash, cash equivalents and investments of $303.1 million, compared to cash of $65.3 million as of December 31, 2019. Fusion expects its cash, cash equivalents and investments as of September 30, 2020 will enable the Company to fund its operations into 2024.
R&D Expenses: Research and development expenses for the third quarter of 2020 were $4.5 million, compared to $2.2 million for the same period in 2019. The increase was primarily due to costs related to our Phase 1 clinical trial of FPI-1434, as well as other development and personnel-related costs.
G&A Expenses: General and administrative expenses for the third quarter of 2020 were $5.8 million, compared to $1.9 million for the same period in 2019. The increase was primarily due to an increase in professional fees, personnel-related costs and other costs including general corporate, insurance and facilities costs.
Net Loss: For the third quarter of 2020, Fusion reported a net loss of $10.0 million, or $0.24 per share, compared with a net loss of $0.6 million, or $0.31 per share, for the same period in 2019. On a non-GAAP basis, excluding a change in fair value of preferred share tranche right liability, net loss was $4.1 million for the third quarter of 2019.
Upcoming Events

Fusion will participate in a virtual "fireside chat" presentation at the Jefferies Virtual London Healthcare Conference on Thursday, November 19 at 1:30pm GMT / 8:30am EST.
Impact of COVID-19

Fusion is closely monitoring how the spread of COVID-19 is affecting the Company’s employees, business, preclinical studies and clinical trials. In response to the COVID-19 pandemic, certain employees have transitioned to working remotely and travel has been restricted. Fusion’s research labs are operating but with reduced capacity.

While Fusion has completed enrollment, dosing and the DLT evaluation period for the third patient cohort in the ongoing Phase 1 clinical trial of FPI-1434, the Company may not be able to enroll additional patient cohorts on the planned timeline due to disruptions at clinical trial sites. Additionally, while certain preclinical activities have restarted, Fusion is currently unable to predict when the Company will fully resume all preclinical activities.

Although the single dose Phase 1 clinical trial has not been materially affected by the COVID-19 pandemic as of September 30, 2020, at this time, there is significant uncertainty relating to the trajectory of the pandemic and whether or not it may cause a delay in the dosing of the first patient in the multi-dosing portion of the study. The impact of related responses and disruptions caused by the COVID-19 pandemic may result in difficulties or delays in initiating, enrolling, conducting or completing the planned and ongoing trials and the incurrence of unforeseen costs as a result of disruptions in clinical supply or preclinical study or clinical trial delays. The impact of COVID-19 on future results will largely depend on future developments, which are highly uncertain and cannot be predicted with confidence.

On November 10, 2020 Galera Therapeutics, Inc. (Nasdaq: GRTX), a clinical-stage biopharmaceutical company focused on developing and commercializing a pipeline of novel, proprietary therapeutics that have the potential to transform radiotherapy in cancer, reported financial results for the third quarter ended September 30, 2020, and provided business updates (Press release, Galera Therapeutics, NOV 10, 2020, View Source [SID1234570503]).

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"We continue to make great strides advancing the clinical development of our small molecule superoxide dismutase mimetics’ ability to address radiation toxicities and augment the anti-cancer efficacy of radiation," said Mel Sorensen, M.D., President and CEO of Galera. "We are delighted with the encouraging data from our placebo-controlled trial of GC4419 in combination with stereotactic body radiation therapy (SBRT) for patients with locally advanced pancreatic cancer (LAPC), which were presented during a late-breaker session at the American Society for Radiation Oncology (ASTRO) 2020 Annual Meeting. The findings are the first clinical evidence supporting our extensive preclinical science that showed synergy of our dismutase mimetics with SBRT. In this first trial with the addition of a dismutase mimetic to SBRT in patients, we observed better tumor responses, saw more patients succeed in going to surgical resection, and are particularly pleased by the initial signal in survival. With these promising early activity results in hand, coupled with the preliminary safety findings of the combination, we look forward to continuing to advance the potential of our dismutase mimetics to enhance the anti-cancer efficacy of SBRT and improve outcomes for cancer patients. We have initiated the GRECO-1 Phase 1/2 trial of GC4711 with SBRT in non-small cell lung cancer (NSCLC), and also anticipate initiating a Phase 2b trial of GC4711 with SBRT in pancreatic cancer (GRECO-2) in the first half of 2021. Our most advanced program, the ROMAN Phase 3 trial, continues to enroll well and we look forward to reporting topline results in the second half of 2021."

Third Quarter 2020 and Recent Corporate Highlights

In October, presented interim efficacy and safety data from the randomized, double-blind, multicenter, placebo-controlled pilot Phase 1/2 clinical trial of avasopasem manganese (GC4419) in combination with SBRT in patients with LAPC at ASTRO. In the analysis of the intent-to-treat population, multiple endpoints to date show a positive trend in favor of improved anti-cancer efficacy with avasopasem compared to placebo. While many of the patients are early in their follow-up post treatment, addition of the dismutase mimetic to SBRT appears to improve overall survival (OS) versus placebo (HR=0.4, 95% CI: 0.12-1.11; median OS not yet reached for avasopasem vs. 38.7 weeks for placebo; p=0.06). Best overall response within the SBRT field was partial response, according to modified RECIST criteria, or better in 33% of avasopasem patients versus 17% of placebo patients. Five patients in the avasopasem arm and two in the placebo arm were surgically resected. Among the resected avasopasem patients, all five achieved clear margins (R0), compared to only one of the two in the placebo arm. Progression-free survival hazard ratio as of the cut-off date also appears to favor the avasopasem arm (HR=0.6, 95% CI: 0.23-1.56; p=0.29). Toxicity was comparable across both treatment arms, with no significant differences in overall or Grade 3 GI toxicity post-SBRT. The data presented included all patients followed for a minimum of three months and 19 for more than one year, with data through August 24, 2020. The Company plans to provide an update on this trial with at least one year of follow-up on all patients in the second half of 2021.

In October, announced that the first patient had been dosed in the Phase 1/2 GRECO-1 trial of GC4711 in combination with SBRT in patients with central or large peripheral NSCLC tumors. GC4711 is Galera’s second highly selective small molecule superoxide dismutase mimetic candidate and is being developed specifically for use in combination with SBRT. Following a safety run-in cohort, up to 66 NSCLC patients with locally advanced disease will receive GC4711 with SBRT or placebo with SBRT over five consecutive weekdays in a first stage of the randomized, double-blind, placebo-controlled Phase 2 portion of the GRECO-1 trial. A second stage is planned to add a checkpoint inhibitor to the SBRT combination. The GRECO-1 trial is supported in part by a recently awarded Small Business Innovation Research grant (4R44CA206795-02) from the National Cancer Institute of the National Institutes of Health. The Company anticipates reporting topline data from the first stage of this trial in the first half of 2022.

In October, hosted a virtual Key Opinion Leader (KOL) event featuring Sarah Hoffe, M.D., Section Head of GI Radiation Oncology and Senior Member at Moffitt Cancer Center. Dr. Hoffe provided an overview of the management of patients with localized pancreatic cancer, including the current clinical treatment paradigm and the use of SBRT.

In September, announced the first patient had been dosed in a pilot Phase 2 clinical trial of avasopasem to evaluate its ability to improve 28-day mortality in hospitalized patients who are critically ill with COVID-19. The Company anticipates reporting topline data from this trial in the first half of 2021.

Continued enrollment in multiple clinical trials of avasopasem for radiation-induced toxicities, including the Phase 3 ROMAN trial to assess its ability to reduce the incidence and severity of severe oral mucositis induced by radiotherapy in patients with locally advanced head and neck cancer (HNC), the Phase 2a EUSOM multi-center trial in Europe assessing the safety of avasopasem in patients with HNC undergoing standard-of-care radiotherapy, as well as the AESOP Phase 2a trial to assess its ability to reduce the incidence of esophagitis induced by radiotherapy in patients with lung cancer. The Company remains on track to announce topline data from the ROMAN trial in the second half of 2021.
Third Quarter 2020 Financial Highlights

Research and development expenses were $12.1 million in the third quarter of 2020, compared to $11.0 million for the same period in 2019. The increase was primarily attributable to avasopasem development costs due to increased expenses in the Phase 3 ROMAN trial, additional clinical trials including the Phase 2a trial for the treatment of esophagitis in patients with lung cancer and the Phase 2a multi-center trial in Europe assessing the safety of avasopasem in patients with HNC. In addition, employee-related costs also increased due to increased headcount and share-based compensation expense. The increases were partially offset by decreased avasopasem preclinical spend and decreased GC4711 development expenses.

General and administrative expenses were $3.9 million in the third quarter of 2020, compared to $1.8 million for the same period in 2019. The increase was primarily the result of employee-related costs from increased headcount and share-based compensation expense, and increased insurance, professional fees and other operating costs as a result of becoming a public company.

Galera reported a net loss of $(17.1) million, or $(0.69) per share, for the third quarter of 2020, compared to a net loss of $(13.4) million, or $(51.43) per share, for the same period in 2019.

As of September 30, 2020, Galera had cash, cash equivalents and short-term investments of $89.2 million. Galera expects that its existing cash, cash equivalents and short-term investments, together with the expected payments from Blackstone in the amount of $57.5 million upon the achievement of certain clinical enrollment milestones in the ROMAN trial and the anti-cancer program in combination with SBRT under the amended royalty agreement, will enable Galera to fund its operating expenses and capital expenditure requirements into the second half of 2022.

On November 10, 2020 Precision BioSciences, Inc. (Nasdaq: DTIL) a clinical-stage biotechnology company dedicated to improving life with its novel and proprietary ARCUS genome editing platform, reported financial results for the third quarter ended September 30, 2020 and provided a business update (Press release, Precision Biosciences, NOV 10, 2020, View Source [SID1234570502]).

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"Our achievements from this past quarter reflect increasing momentum with the ARCUS genome editing platform to develop a novel pipeline of allogeneic CAR T and in vivo gene correction therapeutic candidates," said Matt Kane, CEO and co-founder of Precision BioSciences. "For our clinical portfolio, we expanded our existing partnership with Servier by adding four new targets, including two solid tumor and two hematologic programs, and entered a new clinical collaboration with SpringWorks Therapeutics for our multiple myeloma study. The PTAB issued judgements in our favor in both of the patent interferences involving our patented single-step CAR knock-in/T cell receptor (TCR) knock-out approach, which underscores the novelty of this precise editing process for allogeneic CAR T cell therapies as part of the emerging landscape in oncology."

Recent Developments and Upcoming Milestones:

Allogeneic CAR T Portfolio:

Expanded Development Collaboration with Servier: In September 2020, Precision announced, in collaboration with Servier, that the companies had added two additional hematological cancer targets beyond CD19 and two new solid tumor targets to its existing CAR T development and commercial license agreement. With the addition of these new targets, Precision expects to receive milestone payments in the remainder of 2020 and in 2021. Precision may also be eligible to receive option fees, as well as clinical, regulatory and sales milestone payments in addition to royalties on product sales.

PBCAR0191: In August 2020, Precision announced that the U.S. Food and Drug Administration (FDA) granted Fast Track Designation to PBCAR0191 for B-ALL. Precision also holds Orphan Drug Designation from the FDA for this program in mantle cell lymphoma (MCL), an aggressive subtype of non-Hodgkin lymphoma (NHL). PBCAR0191 is being developed in collaboration with Servier. Precision expects to present updated interim clinical data from both the NHL and B-ALL cohorts of this trial before year-end 2020 via a Company-sponsored event.

PBCAR269A: In September 2020, Precision announced that the FDA granted Fast Track Designation for PBCAR269A, Precision’s wholly-owned investigational allogeneic CAR T candidate targeting B-cell maturation antigen (BCMA), for the treatment of R/R multiple myeloma. PBCAR269A was also previously granted Orphan Drug Designation for this indication by the FDA.

Also, in September 2020, Precision announced a clinical collaboration with SpringWorks Therapeutics to evaluate PBCAR269A in combination with nirogacestat, SpringWorks’ investigational gamma secretase inhibitor. The companies have formed a joint steering committee to oversee the combination arm of Precision’s Phase 1/2a clinical study, which is expected to commence in the first half of 2021, pending discussions with regulators.

PBCAR020A: Precision continues to enroll patients in the PBCAR020A, a wholly-owned investigational allogeneic anti-CD20 CAR T therapy, in patients with R/R NHL including patients with R/R chronic lymphocytic leukemia or R/R small lymphocytic lymphoma.

In Vivo Gene Correction Portfolio:

PH1 Program: Pre-clinical research has continued to progress for Precision’s wholly-owned primary hyperoxaluria type 1 (PH1) gene correction program, which is designed to use ARCUS to knock-out the HAO1 gene as a potential one-time treatment for this rare genetic disease. The Company expects to provide an update on this program in the first half of 2021.

Corporate:

Intellectual Property Protection: Precision continued to expand its intellectual property portfolio which, to-date, includes over 65 issued patents in the U.S. and other countries directed to the ARCUS platform and its uses. Precision has recently been issued several patents relating to its CAR T programs, including a U.S. patent with composition of matter claims for Precision’s proprietary Novel 6 (N6) co-stimulatory domain used in its CAR T cell candidates. Precision also prevailed in two patent interference proceedings before the Patent Trial and Appeal Board (PTAB) at the U.S. Patent and Trademark Office involving certain CAR T patents owned by Precision. Specifically, the involved patents relate to allogeneic CAR T cells produced by inserting a gene encoding a CAR into the TCR alpha chain locus, as well as methods of using those cells for cancer immunotherapy. In the interference proceedings, a third party argued that it had invented the technology in 2012. The PTAB, however, found that the third-party patent application did not satisfy the written description requirement and rejected these claims, while maintaining the claims in all of Precision’s involved patents.

Alex Kelly Appointed Chief Corporate Affairs Officer: Mr. Kelly joined Precision in October 2020 with extensive leadership experience in communications for biopharmaceutical companies. Most recently he was Executive Vice President, Corporate Affairs and Chief Communications Officer at Allergan where he was also President of the Allergan Foundation. He will oversee all investor relations and corporate communications activities at Precision.

Elo Life Systems:

Alec Hayes, Ph.D. Appointed Vice President of Technology and Products at Elo Life Systems: Dr. Hayes joined Elo in September 2020 from the Coca-Cola Company, where he was Technical Director of Agricultural Technologies, and brings 20 years of technical leadership and industry experience in translational agriculture. He is responsible for Elo’s research and development pipeline and strategic expansion of capabilities to accelerate product development.

Quarter Ended September 30, 2020 Financial Results:

Cash and Cash Equivalents: As of September 30, 2020, Precision had approximately $104.1 million in cash and cash equivalents. The Company expects that existing cash, cash equivalents, expected operational receipts, and available credit will be sufficient to fund operating expenses and capital expenditure requirements into 2022.

Revenues: Total revenues for the quarter ended September 30, 2020 were $7.4 million, compared to $4.9 million for the quarter ended September 30, 2019. The increase of $2.5 million in revenue was primarily the result of an increase in collaboration revenue with Servier, offset by a decrease in collaboration revenue from Gilead.

Research and Development Expenses: Research and development expenses were $24.9 million for the quarter ended September 30, 2020, as compared to $19.8 million for the same period in 2019. The increase of $5.1 million was primarily due to increases in direct research and development expenses related to our ongoing CD19 clinical program as well as increases in employee-related costs associated with increased headcount to support our technology platform development and manufacturing capabilities.

General and Administrative Expenses: General and administrative expenses were $8.5 million for the quarter ended September 30, 2020, as compared to $7.1 million for the same period in 2019. The increase of $1.4 million was primarily due to costs associated with the Company’s growing infrastructure needs.

Net Loss: Net loss was $26.0 million, or $(0.50) per share, for the quarter ended September 30, 2020, compared to a net loss of $20.7 million, or $(0.41) per share, for the same period in 2019.