On February 25, 2021 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 fourth quarter and year ended December 31, 2020 and provided pipeline updates (Press release, AnaptysBio, FEB 25, 2021, View Source [SID1234575663]).

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"We made progress in advancing AnaptysBio’s pipeline during 2020 and look forward to multiple clinical readouts from our wholly-owned programs in 2021. Imsidolimab will continue to be our key focus going forward as we anticipate GPP Phase 3 initiation and Phase 2 topline readouts from five other immune-dermatology indications through 2021 and 2022. We also anticipate commercial launch of dostarlimab this year and meaningful milestone and royalty revenue to AnaptysBio under our GSK partnership," said Hamza Suria, president and chief executive officer of AnaptysBio. "Our strategy is to continue advancing first-in-class immunology-focused therapeutic antibodies through key clinical data catalysts using a capital-efficient business model."

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, our proprietary anti-interleukin-36 receptor (IL-36R) antibody, for the treatment of patients with GPP.
In October, we announced positive topline data from an interim analysis of our imsidolimab GALLOP Phase 2 trial in GPP. Six of 8 patients achieved the primary endpoint of disease improvement upon Day 29, while erythema with skin pustules, which clinically defines GPP, decreased by 94% on Day 29 relative to baseline. We plan to report 16-week data from the GALLOP trial at a medical conference in 2021.
We anticipate initiation of a Phase 3 trial for imsidolimab in GPP during mid-2021 following completion of protocol alignment, and review of 16-week data from the Phase 2 GALLOP trial, with the FDA.
We are also conducting a randomized, placebo-controlled, multi-dose Phase 2 trial in 59 patients with palmoplantar pustulosis, or PPP, also known as the POPLAR trial, with topline data anticipated in Q1 2021.
We have expanded our imsidolimab program into third and fourth new clinical indications, EGFRi-mediated skin toxicities and ichthyosis, with interim top-line data from Phase 2 trials anticipated at the end of 2021 and in 2022, respectively, and we are also expanding the imsidolimab program into fifth and sixth new clinical indications, hidradenitis suppurativa and acne, with initiation of Phase 2 trials in these indications anticipated in Q2 2021.
We initiated a worldwide registry of GPP and PPP patients, named RADIANCE, in Q1 2021, to improve understanding of the patient journey and support enrollment of future trials.
ANB030 (Anti-PD-1 Agonist) Program

We anticipate topline data from our ongoing Phase 1 healthy volunteer clinical trial of ANB030, our wholly-owned PD-1 agonist antibody, designed to assess the safety, pharmacokinetics and pharmacodynamics of ANB030 in single and multiple ascending dose cohorts in mid-2021.
Preclinical translational data using ANB030 was presented in March 2020 at the Festival of Biologics Meeting.
We anticipate initiating Phase 2 trials of ANB030 in alopecia areata and vitiligo in Q4 2021.
ANB032 (Anti-BTLA Modulator) Program

We filed a Clinical Trial Notification ("CTN") in Australia for ANB032, our wholly-owned BTLA modulator antibody, during the first quarter of 2021 and anticipate initiating a healthy volunteer Phase 1 trial in the first half of 2021 upon clearance of the CTN.
We presented preclinical data regarding ANB032 at the 2020 Federation of Clinical Immunology Societies (FOCIS) Virtual Annual Meeting in October 2020.
Etokimab (ANB020 Anti-IL-33) Program

We discontinued further development of etokimab, our anti-IL-33 antibody previously referred to as ANB020, following review of topline week 16 data from the approximately 100-patient ECLIPSE trial in chronic rhinosinusitis with nasal polyps (CRSwNP), where patients dosed with etokimab every four (q4w) or eight weeks (q8w) failed to achieve statistically significant over placebo on either co-primary endpoint.
Dostarlimab (Anti-PD-1 Antagonist) Program Partnered with GSK

In October 2020, we amended our immuno-oncology collaboration with GSK resulting in increased financial consideration to AnaptysBio. Royalties due to AnaptysBio for dostarlimab were increased to 8-25% of global net sales, where AnaptysBio will receive 8% of annual global net sales below $1 billion, and 12-25% of net sales above $1 billion. The $1.1 billion in cash milestone payments due under the collaboration agreement remain unchanged, and AnaptysBio anticipates receiving $75 million in such cash milestones over the next 18 months as dostarlimab obtains FDA and EMA regulatory approval for the first two indications. An additional $165 million in sales milestones is anticipated by AnaptysBio upon achievement of certain dostarlimab annual sales revenues. GSK also agreed, starting January 1, 2021, to pay AnaptysBio a 1% royalty on all of GSK’s global net sales of Zejula. In addition, GSK paid AnaptysBio a one-time cash payment of $60 million in Q4 2020. In exchange, AnaptysBio provided GSK with freedom to conduct development and commercialization of Zejula in combination with third-party molecules and settled the dispute between AnaptysBio and GSK.
US BLA and European Union EMA approvals for dostarlimab are anticipated for endometrial cancer in H1 2021, which will result in $20 million and $10 million milestone payments, respectively. The FDA recently accepted a subsequent US BLA for dostarlimab in pan-deficient mismatch repair tumors and we anticipate receiving a $10 million payment from GSK in Q1 2021 as a result of this milestone.
Board of Directors

In January 2021, the Company appointed Dr. Magda Marquet to its board of directors. She is the co-founder of AltheaDx, a commercial stage, precision medicine company, and co-founded Althea Technologies and as its co-CEO led the company to become a highly profitable, commercial company. Prior to starting Althea Technologies, Dr. Marquet held several positions in pharmaceutical development in companies such as Vical and Amylin Pharmaceuticals. She currently serves on the Board of Directors of Arcturus Therapeutics, Micronoma, Matrisys Biosciences and ProciseDx.
Fourth Quarter Financial Results

Cash, cash equivalents and investments totaled $411.2 million as of December 31, 2020 compared to $428.5 million as of December 31, 2019, for a net decrease of $17.3 million. The decrease relates primarily to cash used for operating activities partially offset by an increase in collaboration revenue of $67.0 million.
Collaboration revenue was $60.0 million and $75.0 million for the three and twelve months ended December 31, 2020, which related to milestone payments for successful BLA and MAA filings for dostarlimab and the $60.0 million amendment related payment from GSK, compared to $3.0 million and $8.0 million for the three and twelve months ended December 31, 2019.
Research and development expenses were $21.6 million and $80.0 million for the three and twelve months ended December 31, 2020, compared to $21.4 million and $99.3 million for the three and twelve months ended December 31, 2019. The annual decrease was due primarily to reduced outside services for manufacturing and clinical activities based on the timing of projects.
General and administrative expenses were $5.1 million and $18.9 million for the three and twelve months ended December 31, 2020, compared to $3.8 million and $16.1 million for the three and twelve months ended December 31, 2019. The increase was due primarily to increased legal and insurance expenses.
Net income was $33.6 million for the three months ended December 31, 2020, or a net income per share of $1.23 and a net loss of $19.9 million for the twelve months ended December 31, 2020, or a net loss per share of $0.73, compared to a net loss of $20.3 million and $97.3 million for the three and twelve months ended December 31, 2019, or a net loss per share of $0.75 and $3.60.
Financial Guidance

AnaptysBio expects its net cash burn in 2021 will be close to $100 million. We anticipate that our cash, cash equivalents and anticipated revenues will fund our current operating plan at least into 2024.

On February 25, 2021 Caladrius Biosciences, Inc. (Nasdaq: CLBS) ("Caladrius" or the "Company"), a clinical-stage biopharmaceutical company dedicated to the development of cellular therapies designed to reverse disease, reported financial results for the three and twelve months ended December 31, 2020 (Press release, Caladrius Biosciences, FEB 25, 2021, View Source [SID1234575662]).

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"Despite the continued headwinds of the global pandemic, we are pleased to report continued progress of our development programs as well as an improved financial situation during the fourth quarter and full year of 2020, which reflect the resiliency, creativity and strength of our team and the growing optimism associated with our CD34+ cell technology-based clinical programs," stated David J. Mazzo, Ph.D., President and Chief Executive Officer of Caladrius. "We ended 2020 in a strong financial and strategic position and have set the stage for key clinical enrollment milestones this year.

"Importantly, we have continued the operational momentum into 2021 with an even further strengthened balance sheet, giving us the confidence and means to expand program development and execute on our business priorities," Dr. Mazzo concluded.

Product Development and Financing Highlights

CLBS16 for the treatment of coronary microvascular dysfunction

Caladrius reported in May 2020 the compelling positive results of its ESCaPE-CMD Phase 2a study of CLBS16 for the treatment of coronary microvascular dysfunction ("CMD"), a disease that continues to be underdiagnosed and potentially afflicts millions annually – a vast majority of whom are female – with no current treatment options. The Company is committed to raising awareness of this growing women’s health crisis and finding an effective treatment for it. Consequently, Caladrius recently initiated a rigorous 105-subject Phase 2b clinical trial (the FREEDOM trial), which, to our knowledge, is the first controlled regenerative medicine trial in CMD, and, which is currently recruiting and treating patients and is targeted to complete enrollment by the end of 2021 with top line data anticipated for the third quarter of 2022. This double-blind, randomized, placebo-controlled Phase 2b trial will evaluate the efficacy and safety of delivering autologous CD34+ cells in subjects with CMD and without obstructive coronary artery disease. In support of the FREEDOM trial, the Company is engaging with the American Heart Association for a variety of initiatives around Heart Health Month (February) and the "Go Red for Women" campaign to help raise awareness of CMD.

HONEDRA (CLBS12) for the treatment of critical limb ischemia

The Company’s open-label, registration-eligible study of SAKIGAKE-designated HONEDRA in Japan for the treatment of critical limb ischemia ("CLI") and Buerger’s Disease (an orphan-sized subset of CLI) has shown strong results to date. The initial responses observed in the subjects who have reached an endpoint in this study are consistent with a therapeutic effect and safety profile reported by previously published clinical trials in Japan and the USA. Although the study’s enrollment has been slowed by the pandemic’s impact in Japan, the Company is encouraged by the patient pre-screening pipeline and hopes to conclude trial enrollment during the second quarter of 2021. While the final outcome of the trial will depend on all data from all subjects, the data to date is very encouraging (~60% of subjects in the completed Buerger’s Disease cohort have reached a positive "CLI-free" endpoint, despite a natural history of such patients predicting continuing disease progression to amputation).

CLBS201 for the treatment of pre-dialysis chronic kidney disease

Our most recently proposed development program, CLBS201, is designed to assess the safety and efficacy of CD34+ cell therapy as a treatment for chronic kidney disease ("CKD") in patients not yet requiring dialysis. Based on a wealth of published preclinical and early clinical data, it appears that the innate ability of CD34+ cells to promote the growth of new microvasculature could be a means to attenuate the progression of the disease or even reverse the course of CKD. Caladrius plans to file an IND for this program in the second quarter of 2021 and to initiate a Phase 1/2 proof-of-concept study of CLBS201 in a moderate to severe CKD population shortly thereafter. Chronic Kidney Disease remains a largely unmet medical need, especially as the general population ages and the incidence of diabetes and hypertension increases.

OLOGO for the treatment of no option refractory disabling angina ("NORDA")

We acquired the rights to data and regulatory filings for a CD34+ cell therapy program for NORDA that had been advanced to Phase 3 by a previous sponsor. Based on the clinical evidence from the completed studies that a single administration of OLOGO reduces mortality, improves angina and increases exercise capacity in patients with otherwise untreatable angina, this product received Regenerative Medicine Advanced Therapy ("RMAT") designation from the FDA. We remain in discussion with the FDA regarding the size and scope of a phase 3 trial which, in combination with previously filed Phase 1, 2 and 3 data, will be considered for the registration of OLOGO. Notably, the RMAT designation affords the product a 6-month review time for a biologics license application ("BLA"), once submitted.

Closed on an additional $90.0 million in funding

In January 2021, the Company announced that it had closed on a $25.0 million capital raise through the sale of its common stock to several institutional and accredited investors in a private placement priced at-the-market under Nasdaq rules. In February 2021, the Company announced that it closed a $65.0 million capital raise through the sale of its common stock to several institutional and accredited investors in two registered direct offerings priced at-the-market under Nasdaq rules.

Fourth Quarter and Full Year 2020 Financial Highlights

Research and development expenses for the fourth quarter of 2020 were $2.9 million, a 5% increase compared with $2.8 million for the fourth quarter of 2019, and $9.3 million for the year ended December 31, 2020 compared to $10.8 million for the year ended December 31, 2019, representing a decrease of approximately 14%. Research and development in both the current year and prior year periods focused on the advancement of our ischemic repair platform and related to:

Expenses associated with exploration of our concept program, CLBS119, a CD34+ cell therapy for repair of COVID-19 induced lung damage targeting patients with severe SARS-CoV-2 infection that required ventilatory support due to respiratory failure (this program has since been indefinitely postponed due to the continuous evolution of the targeted patient population);

Ongoing expenses for HONEDRA in critical limb ischemia in Japan, whereby we continue to focus spending on patient enrollment and Japanese NDA preparation (enrollment completion is now targeted for 2Q21 based on the impact of the COVID-19 pandemic in Japan);

Expenses associated with the proof-of-concept study for CLBS16 in coronary microvascular dysfunction, for which study enrollment was completed in the second quarter of 2019 and full results reported in May 2020 and continuing efforts to advance CLBS16 into a Phase 2b study (the FREEDOM trial) in the second half of 2020; and
Expenses associated with the ongoing dialogue with FDA regarding design and execution of confirmatory Phase 3 study of OLOGO in NORDA.
General and administrative expenses, which focus on general corporate related activities, were $2.5 million for the three months ended December 31, 2020, compared to $2.3 million for the three months ended December 31, 2019, and $9.9 million for the year ended December 31, 2020, compared to $9.3 million for the year ended December 31, 2019, representing an increase of 6%.

Overall, net losses were $8.1 million and $19.4 million for the years ended December 31, 2020 and 2019, respectively.

Balance Sheet Highlights

As of December 31, 2020, Caladrius had cash, cash equivalents and marketable securities of $34.6 million and, following the previously mentioned capital raises in January and February 2021, the Company has cash, cash equivalents and marketable securities of approximately $116 million as of February 25, 2021. Based on existing programs and projections, the Company remains confident that its current cash balances will fund its operations for the next several years, notably, through study completion for the Phase 2b for CLBS16, through the registration-eligible study completion for HONEDRA and through the Phase 1/2 Proof-of-Concept study for CLBS201 while still providing capital to explore additional pipeline expansion opportunities.

Conference Call

Caladrius will hold a conference call on Thursday, February 25, 2021, at 4:30 p.m. Eastern time to discuss the financial results, provide a business update and answer questions. To join the conference call, please refer to the dial-in information provided below. The conference call will also be webcast live under the Investors section on the Company’s website at www.caladrius.com.

For those unable to participate in the live conference call, an audio replay will be available approximately two hours after the call has concluded until March 4, 2021, by dialing 855-859-2056 (domestic) or 404-537-3406 (international) and referencing conference ID / passcode: 7372695. A webcast recording of the call will also be archived for 90 days under the Investors section of the Company’s website at www.caladrius.com.

On February 25, 2021 Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a late-stage biotechnology company developing novel T cell-based cancer immunotherapies (tumor-infiltrating lymphocyte, TIL, and peripheral-blood lymphocyte, PBL), today reported fourth quarter and full year 2020 financial results and corporate updates (Press release, Iovance Biotherapeutics, FEB 25, 2021, View Source [SID1234575661]).

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Dr. Maria Fardis, Ph.D., President and Chief Executive Officer of Iovance, stated, "During 2020 we continued to advance our TIL cell therapies in metastatic melanoma, cervical, head and neck, and non-small cell lung cancers. We believe that the growing body of TIL clinical data across multiple late-stage indications in cancer, coupled with combination of TIL and checkpoint inhibitors in earlier stages of disease, validate the significant potential for TIL as a treatment option in multiple solid tumors and stages of cancer. In 2021, our top priority is to continue the dialogue with FDA regarding our potency assays to support a potential BLA submission for lifileucel. We are excited about many opportunities to further strengthen the Iovance leadership in development of TIL cell therapy, manufacturing, and potential commercialization."

Full Year 2020 Highlights and Recent Corporate Updates

Clinical:

TIL therapy, lifileucel, in melanoma: as of a January 2021 corporate update, median duration of response has not been reached at 28.1 months of median study follow up in metastatic melanoma patients from Cohort 2 in the C-144-01 clinical study. Available care for Cohort 2 patients is chemotherapy, with an overall response rate of four to ten percent and overall survival of only seven to eight months.
TIL therapy, lifileucel, in cervical cancer: The C-145-04 study of lifileucel, formerly LN-145, is intended to support a BLA submission for metastatic cervical cancer. Inclusion of both pivotal cohort 1 (post-chemotherapy) and cohort 2 (post-anti-PD-1/PDL-1) in the BLA may strengthen the potential label and reflect the expected upcoming treatment landscape in cervical cancer. Enrollment in both Cohorts 1 and 2 has been completed.
TIL therapy in non-small cell lung cancer (NSCLC): H. Lee Moffitt Cancer Center presented data for Moffitt’s TIL from a Phase 1 lung cancer trial at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Virtual Annual Meeting I. Iovance initiated a potential registration-directed study, IOV-LUN-202, to investigate LN-145 in patients with recurrent or metastatic NSCLC, without driver mutations, who previously received a single line of approved systemic therapy (combined checkpoint inhibitor (CPI) plus chemotherapy). The company continues to investigate LN-145 in several additional NSCLC populations with unmet need across three cohorts in the IOV-COM-202 basket study, including a recently added cohort for LN-145 in combination with ipilimumab/nivolumab.
TIL therapy LN-145 in head and neck squamous cell carcinoma (HNSCC): Initial data for TIL in combination with pembrolizumab in earlier lines of therapy were presented for the first time at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting. Patients from Cohort 2A in the IOV-COM-202 study with HNSCC who received LN-145 in combination with pembrolizumab showed an overall response rate (ORR) of 44% and median duration of response had not been reached at 8.6 months of median study follow up (n=9). The company subsequently expanded enrollment in Cohort 2A to gather data in additional patients. In study C-145-03, target enrollment was achieved, and the study was closed to enrollment.
TIL clinical study enrollment updates: To date, over 400 patients have been dosed with Iovance TIL products with more than a 90 percent manufacturing success rate. Recruitment continues in C-145-04 study in cervical cancer, the IOV-COM-202 study in solid tumors, the IOV-LUN-202 study in NSCLC and the IOV-CLL-01 study in CLL/SLL. The COVID-19 pandemic may impact the pace of enrollment and site activities in ongoing clinical studies, particularly in cohorts with earlier line patients. Recruitment may improve as the COVID-19 pandemic abates.
Regulatory

Potency assays for lifileucel: during a Type B meeting in the fourth quarter of 2020, Iovance and the U.S. Food and Drug Administration (FDA) did not reach agreement on the potency assays to define TIL. FDA and Iovance reached agreement on duration of follow up for the pivotal cohort for the planned BLA for lifileucel in metastatic melanoma. Additional work and dialogue with FDA continue regarding current and new potency assays in support of the BLA. The BLA submission is anticipated during 2021. Resolution of the potency assay for lifileucel in melanoma is also a key step towards BLA submission plans in cervical cancer.
Manufacturing:

Iovance Cell Therapy Center (iCTC): construction is advancing as planned at the Navy Yard in Philadelphia. Construction of the clean rooms were completed in late 2020 and activities in support of clinical manufacturing are expected to initiate in the coming weeks. Commercial manufacturing is on track for start in 2022.
Generation 3 (Gen 3) manufacturing: a shorter 16-day third generation manufacturing process will be explored in a cohort of metastatic melanoma patients in the IOV-COM-202 study as well as a cohort of NSCLC patients in the IOV-LUN-202 study.
Corporate:

Cash position of $635.0 million on December 31, 2020 is expected to be sufficient into 2023 to deliver on our pipeline programs.
A strong organization of nearly 250 employees, of which 76 percent have more than a year of cell therapy experience, is in place to advance research, development, manufacturing, and commercial launch preparations.
Iovance continues to expand its intellectual property portfolio and currently owns more than 20 granted or allowed U.S. and international patents for compositions and methods of treatment in a broad range of cancers relating to the Gen 2 manufacturing process. Iovance’s portfolio also includes patent applications and granted patents directed towards Gen 3 manufacturing, selected TIL products, stable and transient genetic TIL modifications, and combinations of checkpoint inhibitors and TIL products.
Fourth Quarter and Full Year 2020 Financial Results

Iovance held $635.0 million in cash, cash equivalents, short-term investments and restricted cash at December 31, 2020 compared to $312.5 million at December 31, 2019. The current cash position includes net proceeds of $567.0 million from a common stock public offering in June 2020. The company anticipates that the year-end balance of cash, cash equivalents, short-term investments and restricted cash will be sufficient into 2023.

Jean-Marc Bellemin, Chief Financial Officer, stated, "I am confident that Iovance is in a strong position to continue to execute our operating plan and advance our portfolio in 2021. Our healthy balance sheet will help us deliver on our commitments, both to patients and to our shareholders."

Net loss for the fourth quarter ended December 31, 2020, was $68.4 million, or $0.47 per share, compared to a net loss of $63.6 million, or $0.50 per share, for the fourth quarter ended December 31, 2019. Net loss for full year ended December 31, 2020, was $259.6 million, or $1.88 per share, compared to a net loss of $197.6 million, or $1.59 per share, for the full year ended December 31, 2019.

Research and development expenses were $52.4 million for the fourth quarter ended December 31, 2020, a decrease of $1.8 million compared to $54.2 million for the fourth quarter ended December 31, 2019. Research and development expenses were $201.7 million for the 12 months ended December 31, 2020, an increase of $35.7 million compared to $166.0 million for the full year ended December 31, 2019.

The decrease in research and development expenses in the fourth quarter 2020 over the prior year period was primarily attributable to a decrease in manufacturing and clinical costs following the completion of enrollment in the pivotal cohorts for melanoma and cervical cancer. The increase in research and development expenses in the full year 2020 over the prior full year period was primarily attributable to higher clinical costs, licensing fees and growth of the internal research and development team.

General and administrative expenses were $16.1 million for the fourth quarter ended December 31, 2020, an increase of $5.2 million compared to $10.9 million for the fourth quarter ended December 31, 2019. General and administrative expenses were $60.2 million for the full year ended December 31, 2020, an increase of $19.3 million compared to $40.9 million for the same period ended December 31, 2019.

The increases in general and administrative expenses in the fourth quarter and full year of 2020 compared to the prior year periods were primarily attributable to growth of the internal general and administrative team and higher stock-based compensation expenses.

Webcast and Conference Call

Iovance will host a conference call today at 4:30 p.m. ET to discuss the fourth quarter and year-to-date 2020 financial results and to provide a corporate update. The conference call dial-in numbers are 1-844-646-4465 (domestic) or 1-615-247-0257 (international). The conference ID access number for the call is 9075827. The live webcast can be accessed in the Investors section of the company’s website at View Source The archived webcast will be available for a year in the Investors section at www.iovance.com.

On February 25, 2021 Atreca, Inc. (Atreca) (NASDAQ: BCEL), a clinical-stage biotechnology company focused on developing novel therapeutics generated through a unique discovery platform based on interrogation of the active human immune response, reported financial results for the fourth quarter and full year ended December 31, 2020, and provided an overview of recent developments (Press release, Atreca, FEB 25, 2021, View Source [SID1234575660]).

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"2020 was a successful year for Atreca marked by several key milestones, including the initiation of our first-in-human study of ATRC-101 and the signing of multiple strategic collaborations to both enhance our discovery platform and build our development pipeline," said John Orwin, Chief Executive Officer. "Preclinical data that we presented on ATRC-101 throughout the year highlighted its novel target and mechanism of action, as well as its potential as a combination therapy both with checkpoint inhibitors targeting the PD-1/PD-L1 axis and with chemotherapy. This year we look forward to reporting initial summary data from our Phase 1b trial, initiating combination studies with a checkpoint inhibitor and chemotherapy, and providing an update on our early-stage pipeline."

Recent Developments and Highlights

To date, 10 clinical trial sites have been initiated in the Phase 1b trial evaluating ATRC-101 in multiple solid tumor cancers. Three patients have been enrolled in the fourth dose cohort (10mg/kg) of the dose escalation portion of the trial. Patient enrollment in the fifth and final dose cohort (30mg/kg) is planned to begin following the protocol-specified dose-limiting toxicity assessment period. Atreca expects to announce initial summary data from the study in 2Q 2021.
As allowed by the study protocol, up to three additional patients are being backfilled into the previously cleared third dose cohort (3mg/kg) due to continued interest in the study and in order to collect supplemental data. The dose expansion portion of the study is also being opened with an additional 3mg/kg cohort expected to enroll up to 12 patients. Further cohorts to evaluate ATRC-101 in combination with a PD-1 inhibitor and in combination with a chemotherapeutic agent are planned to begin in 2Q 2021 and 2H 2021, respectively.
Fourth Quarter and Full Year 2020 Financial Results

As of December 31, 2020, cash and cash equivalents and short-term investments totaled $240.1 million.

Research and development expenses for the year ended December 31, 2020 were $62.0 million, including non-cash share-based compensation expense of $5.9 million. Research and development expenses for the three months ended December 31, 2020 were $16.8 million, including non-cash share-based compensation expense of $1.4 million.

General and administrative expenses for the year ended December 31, 2020 were $26.8 million, including non-cash share-based compensation expense of $6.6 million. General and administrative expenses for the three months ended December 31, 2020 were $6.6 million, including non-cash share-based compensation expense of $1.7 million.

Atreca reported a net loss of $86.3 million, or basic and diluted net loss per share attributable to common stockholders of $2.70, for the year ended December 31, 2020. The Company reported a net loss of $23.0 million, or basic and diluted net loss per share attributable to common stockholders of $0.63, for the three months ended December 31, 2020.

On February 25, 2021 Exelixis, Inc. (Nasdaq: EXEL) reported that Michael M. Morrissey, Ph.D., the company’s President and Chief Executive Officer will participate in fireside chats at the following virtual investor conferences in March (Press release, Exelixis, FEB 25, 2021, View Source [SID1234575659]):

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Cowen 41st Annual Healthcare Conference: Exelixis is scheduled to present at 2:40 PM EST / 11:40 AM PST on Monday, March 1, 2021.
Barclays Global Healthcare Conference 2021: Exelixis is scheduled to present at 11:30 AM EST / 8:30 AM PST on Tuesday, March 9, 2021.
Oppenheimer 31st Annual Healthcare Conference: Exelixis is scheduled to present at 11:20 AM EDT / 8:20 AM PDT on Tuesday, March 16, 2021.
To access the webcast links, log onto www.exelixis.com and proceed to the News & Events / Event Calendar page under the Investors & Media heading. Please connect to the company’s website at least 15 minutes prior to the presentations to ensure adequate time for any software download that may be required to listen to the webcasts. Replays will also be available at the same location for 14 days.