On November 4, 2021 ImmunityBio, Inc. (NASDAQ: IBRX), a clinical-stage immunotherapy company, reported that Founder, Executive Chairman and Global Chief Scientific and Medical Officer Dr. Patrick Soon-Shiong, M.D., will deliver a company presentation at the 2021 Jefferies London Healthcare Conference, which is being held November 16-18, 2021 (Press release, NantKwest, NOV 4, 2021, View Source [SID1234594371]). Dr. Soon-Shiong will present updates on ImmunityBio’s infectious disease and oncology programs. Management will be available during the conference for virtual one-on-one meetings.

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Presentation Details:

Date: November 18, 2021

Format: The webcast will be available to all conference attendees, on-demand beginning on Thursday, November 18 at 8:00 am GMT/3:00 am EDT through Friday, November 19. The presentation slides will be available in the Investor Relations section of the ImmunityBio website, ir.immunitybio.com, on November 18, 2021.

On November 4, 2021 TG Therapeutics, Inc. (NASDAQ: TGTX), reported the release of six abstracts that will be presented at the upcoming 63rd American Society of Hematology (ASH) (Free ASH Whitepaper) annual meeting and exposition, to be held December 11 – 14, 2021, virtually and also live at the Georgia World Congress Center in Atlanta, Georgia (Press release, TG Therapeutics, NOV 4, 2021, View Source [SID1234594399]). Abstracts are now publicly available online via the ASH (Free ASH Whitepaper) meeting website at www.hematology.org.

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Michael S. Weiss, Chairman and Chief Executive Officer, stated, "We are looking forward to a live ASH (Free ASH Whitepaper) annual meeting this year where we will be sharing six presentations, including three oral presentations. Specifically, we are pleased to share new data from the UNITY-NHL Phase 2b trial showing the U2 combination in patients with relapsed or refractory marginal zone lymphoma and diffuse large b-cell lymphoma. We are also excited to share two novel analyses from the UNITY-CLL Phase 3 trial. One highlighting the outcomes of U2 treated patients who had comorbidities or required certain concomitant medications, both of which represent areas of high unmet need as these patients may be poor candidates for BTK therapy. The other presentation sharing the efficacy and safety of U2 by CLL pre-treatment status, that is, comparing the treatment naïve cohort with the previously treated cohort. Finally, we will also share two presentations from studies evaluating U2 triplet regimens with a BTK, namely TG-1701 and ibrutinib. We believe these presentations showcase the strength of our combination B-cell platform, which has the potential to produce multiple product opportunities in the future."

ASH Presentation Details:

Oral Presentations:
Oral Presentation Title: The Combination of Umbralisib Plus Ublituximab Is Active in Patients with Relapsed or Refractory Marginal Zone Lymphoma (MZL): Results from the Phase 2 Global Unity-NHL Trial

Session Date/Time: Saturday, December 11, 2021 / 10:00 AM ET
Session Name: 623. Mantle Cell, Follicular, and Other B-Cell Lymphomas: Clinical and Epidemiological: Targeted Therapy in Low Grade Lymphoma
Room: Georgia World Congress Center, A411-A412
Lead Author: Julio Chavez, MD, MS, Moffitt Cancer Center, Tampa, FL
Oral Presentation Title: Efficacy and Safety of Umbralisib, Ublituximab (U2), and U2 Plus Bendamustine in Patients with Relapsed or Refractory Diffuse Large B-Cell Lymphoma (DLBCL)

Session Date/Time: Sunday, December 12, 2021 / 5:30 PM ET
Session Name: 626. Aggressive Lymphomas Prospective Therapeutic Trials: Novel Agents and Combinations
Room: Georgia World Congress Center, Thomas Murphy Ballroom 1-2
Lead Author: John Burke, MD, Rocky Mountain Cancer Centers / US Oncology Research, Aurora, CO
Oral Presentation Title: A Phase 2 Study Evaluating the Addition of Ublituximab and Umbralisib (U2) to Ibrutinib in Patients with Chronic Lymphocytic Leukemia (CLL): A Minimal Residual Disease (MRD)-Driven, Time-Limited Approach

Session Date/Time: Sunday, December 12, 2021 / 10:30 AM ET
Session Name: 642. Chronic Lymphocytic Leukemia: Clinical and Epidemiological I
Room: Georgia World Congress Center, B401-B402
Lead Author: Lindsey E. Roeker, MD, CLL Program, Leukemia Service, Division of Hematologic Oncology, Memorial Sloan-Kettering Cancer Center, New York, NY
Poster Presentations:
Poster Presentation Title: The Selective Bruton Tyrosine Kinase (BTK) Inhibitor TG-1701 As Monotherapy and in Combination with Ublituximab and Umbralisib (U2) in Patients with B-Cell Malignancies

Date/Time: Saturday, December 11, 2021 / 5:30 PM – 7:30 PM ET
Session Name: 642. Chronic Lymphocytic Leukemia: Clinical and Epidemiological: Poster I
Location: Georgia World Congress Center, Hall B5
Lead Author: Chan Y. Cheah, MBBS, DMSc, Linear Clinical Research, Nedlands, Australia; Medical School, University of Western Australia, Perth, Australia; and Department of Haematology, Sir Charles Gairdner Hospital, Perth, Australia
Poster Presentation Title: Favorable Outcomes for Patients Treated with U2 with Co-Morbidities or Concomitant Medications: A Retrospective Analysis of Unity-CLL Phase 3 Trial

Date: Monday, December 13, 2021 / 6:00 PM – 8:00 PM
Session Name: 642. Chronic Lymphocytic Leukemia: Clinical and Epidemiological: Poster III
Location: Georgia World Congress Center, Hall B5
Lead Author: Javier Pinilla-Ibarz, MD, Lymphoma Section Head, Director of Immunotherapy, Malignant Hematology Division at the H. Lee Moffitt Cancer Center in Tampa, Florida
Poster Presentation Title: Efficacy and Safety of Ublituximab in Combination with Umbralisib (U2) in Patients with Chronic Lymphocytic Leukemia (CLL) By Treatment Status: A Sub-Analysis of the Phase 3 Unity-CLL Study

Date/Time: Monday, December 13, 2021 / 6:00 PM – 8:00 PM
Session Name: 642. Chronic Lymphocytic Leukemia: Clinical and Epidemiological: Poster III
Location: Georgia World Congress Center, Hall B5
Lead Author: Ryan Jacobs, MD, Department of Hematology, Lymphoma Division, Assistant Professor of Medicine, Levine Cancer Institute/Atrium Health, Charlotte, NC
Abstracts are now publicly available via the ASH (Free ASH Whitepaper) meeting website at www.hematology.org. Final presentations will be accessible at the above dates/times via the publications page of TG corporate website at View Source

On November 4, 2021 Adagene Inc. ("Adagene") (Nasdaq: ADAG), a platform-driven, clinical-stage biopharmaceutical company committed to transforming the discovery and development of novel antibody-based immunotherapies, reported publication of two abstracts featuring preclinical data from its expanding pipeline in advance of the 63rd ASH (Free ASH Whitepaper) Annual Meeting & Exposition (Press release, Adagene, NOV 4, 2021, View Source [SID1234594415]).

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The preclinical results show compelling differentiation of ADG153, an anti-CD47 SAFEbody and ADG152, a CD20xCD3 POWERbody integrating the company’s proprietary bispecific T-cell engager (TCE) platform with SAFEbody masking technology. The full abstracts will be available on the ASH (Free ASH Whitepaper) Annual Meeting and Exposition website in anticipation of poster presentations at the hybrid meeting being held virtually and in Atlanta, Georgia from December 11-14, 2021.

Details for the poster presentations during ASH (Free ASH Whitepaper) 2021 include:

Title: ADG153, an Anti-CD47 Monoclonal Antibody Prodrug, Has Strong In Vivo Anti-Tumor Activity, Minimal RBC-Related and Antigen Sink Liabilities, and Extended Half Life in Comparison with Benchmark Clinical Antibodies of the Same IgG Subclass
Publication Number: 3342
Date: Monday, December 13, 2021
Poster Session III: 9:00 a.m. – 8:00 p.m. ET
Location & Time (for in-person participants): Hall B5 from 6:00 p.m. – 8:00 p.m. ET

Title: ADG152, a Novel CD20xCD3 T Cell Engager Prodrug with Enhanced Therapeutic Index, Demonstrates Strong Anti-Tumor Activity with Improved Safety
Publication Number: 1204
Date: Saturday, December 11, 2021
Poster Session I: 9:00 a.m. – 7:30 p.m. ET
Location & Time (for in-person participants): Hall B5 from 5:30 p.m. – 7:30 p.m. ET
"We are excited to share the first preclinical results from our ongoing evaluation of ADG152 and ADG153, which are two novel programs emerging from our deep, broad, and differentiated pipeline," said Peter Luo, Ph.D., Co-founder, Chief Executive Officer and Chairman of Adagene. "The known challenges of targeting CD47 — specifically, the need for a Fc dependent efficacious antibody without triggering on-target off tumor liabilities, including binding to red blood cells or showing significant antigen sink in healthy cells — and those of bispecific CD3 TCEs — a clinically validated, powerful modality with cytokine release syndrome limiting their utility — are the ideal problems for our AI-powered platform and antibody engineering teams to overcome in a tailor-made manner."

Dr. Luo continued, "We look forward to presenting more detailed results during the ASH (Free ASH Whitepaper) sessions, including new data from our ADG153 program, with one of the first ever anti-CD47 antibodies of the IgG1 isotype on track for clinical development. Additionally, ADG152 is the first novel bispecific TCE that incorporates our SAFEbody anti-CD3 antibody which has a low binding affinity and demonstrates strong anti-tumor activity while maintaining an impressive control of cytokine release in vivo, an outstanding issue facing many TCEs in clinical development. We are extremely encouraged by the data supporting differentiation of these candidates, which collectively showcase how we are on the forefront of antibody discovery and development to address patient needs."

The preclinical findings also reflect the advantages of the company’s AI-driven antibody discovery and development platform, which integrates the dynamic properties of antibody-based therapeutics into structure and design. Specifically, by targeting novel epitopes and introducing conditionally-activated masking technology, Adagene develops antibody candidates with tailor-made safety and efficacy profiles. When applied to powerful antibody-based modalities such as bispecific TCEs and antibody-drug conjugates, these therapeutic candidates are designed to reach beyond the therapeutic potency of traditional monospecific antibodies, while maintaining patient safety. These transformative technologies are known as NEObody, SAFEbody and POWERbody.

Both ADG152 and ADG153 are potential Investigational New Drug candidates from Adagene’s growing portfolio of preclinical discovery programs, five of which are in IND-enabling studies.

On November 4, 2021 NGM Biopharmaceuticals, Inc. (NGM) (Nasdaq: NGM), a biotechnology company focused on discovering and developing transformative therapeutics for patients, reported financial results for the quarterly period ended September 30, 2021 (Press release, NGM Biopharmaceuticals, NOV 4, 2021, View Source [SID1234594432]).

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"This quarter we made notable progress advancing NGM’s oncology portfolio, now four assets strong, all generated by our in-house discovery engine and wholly owned by NGM," said David J. Woodhouse, Ph.D., Chief Executive Officer at NGM. "We reported the first preliminary human data from our NGM120 trial at ESMO (Free ESMO Whitepaper) 2021 and also unveiled our third myeloid reprogramming program, NGM831. Over the past 12 months, we have pulled back the curtain on the intensive discovery work in oncology that has been underway at NGM for several years. Leveraging integrated world-class target discovery research and protein engineering, we’ve created multiple oncology product candidates each with the potential to become next-generation treatment options to help patients mobilize their own immune systems to fight cancer more effectively. We strongly believe myeloid cell reprogramming can be an important additional approach to augment anti-tumor immunity and our portfolio of product candidates provide multiple opportunities to harness that biology."

Key Third Quarter and Recent Highlights

Cancer

Presented preliminary findings from ongoing Phase 1a/1b dose escalation study of NGM120, a first-in-class anti-GDNF family receptor alpha like (GFRAL) antagonist antibody, in patients with advanced solid tumors at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Virtual Congress. Preliminary results showed that treatment with the drug was well tolerated with no dose-limiting toxicities. All six evaluable metastatic pancreatic cancer patients in the Phase 1b combination cohort (NGM120 in combination with gemcitabine + Nab-paclitaxel) demonstrated disease control at 16 weeks, with three partial responses (PR) and three stable disease (SD). Four metastatic pancreatic cancer patients in the Phase 1b cohort continued to exhibit PR/SD beyond 36 weeks at the July 26 data cut-off, compared to the historic median progression-free survival in metastatic pancreatic cancer of 22 weeks1. As of September 16, 2021, three of those four patients remained on drug, with two patients exhibiting PR and one patient exhibiting SD beyond 44 weeks.
Continued enrollment in a Phase 2 placebo-controlled component of the ongoing Phase 1/2 PINNACLES study, with the Phase 2 component testing NGM120 as a first-line treatment in combination with gemcitabine and Nab-paclitaxel in patients with metastatic pancreatic cancer. In March 2021, NGM initiated a multi-center, randomized, single-blind (sponsor unblinded), placebo-controlled component of NGM120 in combination with gemcitabine and Nab-paclitaxel as a first-line treatment in patients with metastatic pancreatic cancer as part of the ongoing Phase 1/2 trial. The Phase 2 component of the study is designed to enroll approximately 60 patients and will assess the efficacy, safety and tolerability of NGM120 or placebo in combination with gemcitabine and Nab-paclitaxel against both cancer and cancer-related cachexia endpoints.
Initiated the Phase 1 component of a Phase 1/2 Study of NGM707, a novel dual antagonist antibody that inhibits the Immunoglobulin-like Transcript 2 (ILT2) and Immunoglobulin-like Transcript 4 (ILT4) receptors, for the treatment of patients with advanced solid tumors. The Phase 1 portion (n≅60) of the study includes a monotherapy dose escalation arm (Part 1a) and a dose-finding arm in combination with KEYTRUDA (pembrolizumab) (Part 1b). The Phase 2 portion (n≅120) of the study will employ a basket design that will include expansion cohorts of patients treated with NGM707 monotherapy (Part 2a) or NGM707 in combination with KEYTRUDA (Part 2b) in a variety of selected solid tumor types.
Disclosed fourth oncology development candidate, NGM831, coinciding with a publication on the ILT3-fibronectin pathway in Cancer Immunology Research. In August 2021, NGM disclosed its fourth oncology development candidate, NGM831, an antagonist antibody designed to block the interaction of Immunoglobulin-like transcript 3 (ILT3) with fibronectin, a key component of tumor stroma, as well as with other ligands. ILT3-fibronectin interactions within the tumor microenvironment may form a stromal checkpoint that actively suppresses myeloid cell function and inhibits tumor activity. NGM plans to advance NGM831 into a Phase 1 study in the first half of 2022. NGM831 joins NGM438 to become the second program in the Company’s oncology portfolio being studied for the potential to impact the tumor microenvironment by releasing stromal checkpoints.
Retinal disease

Completed enrollment in the Phase 2 CATALINA study of NGM621 in patients with geographic atrophy. NGM completed enrollment in the Phase 2 CATALINA study, a multi-center, randomized, double-masked, sham-controlled clinical trial to evaluate the safety and efficacy of intravitreal, or IVT, injections of NGM621 every four weeks or every eight weeks in 320 patients with geographic atrophy in one or both eyes secondary to age-related macular degeneration. The primary efficacy endpoint is the rate of change in geographic atrophy lesion area, as measured by fundus autofluorescence imaging over 52 weeks of treatment. NGM anticipates reporting topline data from the CATALINA study in the second half of 2022. Upon completion of a proof-of-concept study in humans, Merck has a one-time option to license NGM621 and its related molecules or to license NGM621 and its related molecules together with all other ophthalmology compounds included within the scope of our ongoing collaboration with Merck.
Liver and metabolic diseases

Continued enrollment in Phase 2b ALPINE 4 study of aldafermin in patients with compensated non-alcoholic steatohepatitis (NASH) cirrhosis (liver fibrosis stage 4, or F4). The 48-week study is designed to assess the efficacy, safety and tolerability of 0.3 mg, 1 mg and 3 mg doses of aldafermin compared to placebo.
Merck continued enrollment in its Phase 2b study of MK-3655 in patients with NASH and liver fibrosis stage 2 or 3 (F2 or F3). In November 2020, Merck initiated a global Phase 2b multicenter study of MK-3655 for the treatment of patients with F2 or F3 NASH. The 52-week randomized, double-blind study is designed to enroll approximately 320 patients and will assess the efficacy, safety and tolerability of 50 mg, 100 mg and 300 mg once monthly doses of MK-3655 compared to placebo. The primary objective of the Phase 2b study is NASH resolution without worsening of fibrosis after 52 weeks. Merck licensed MK-3655 following NGM’s completion of a proof-of-concept study. NGM retains an option, at the initiation of the first Phase 3 clinical trial for MK-3655, to either receive milestone and royalty payments or to co-fund development and participate in a global cost and revenue sharing arrangement of up to 50%.
Third Quarter 2021 Financial Results

NGM reported a net loss of $28.9 million for the quarter ended September 30, 2021, compared to a net loss of $29.8 million for the same period in 2020.
Related party revenue from our collaboration with Merck was $18.6 million for the quarter ended September 30, 2021, compared to $23.5 million for the same period in 2020. Related party revenue decreased $4.9 million in the quarter ended September 30, 2021 as compared to the prior year period, primarily due to a decrease in research and development revenue.
R&D expenses were $38.7 million for the quarter ended September 30, 2021, compared to $47.0 million for the same period in 2020. R&D expenses decreased $8.3 million in the quarter as compared to the prior year period, primarily due to decreases in expenses for our manufacturing activities and our clinical trials of aldafermin.
General and administrative expenses were $8.9 million for the quarter ended September 30, 2021, compared to $6.5 million for the same period in 2020. The $2.4 million increase in general and administrative expenses in 2021 was primarily attributable to increases in personnel-related expenses driven by increased headcount, as well as external expenses to support our operations.
Cash, cash equivalents and short-term marketable securities were $383.4 million as of September 30, 2021, compared to $295.2 million as of December 31, 2020.

On November 4, 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 third quarter ended September 30, 2021 and provided pipeline updates (Press release, AnaptysBio, NOV 4, 2021, View Source [SID1234594448]).

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"Our wholly-owned pipeline continues to make progress with the recent initiation of our imsidolimab GEMINI-1 Phase 3 trial in GPP and anticipated initiation of our rosnilimab AZURE alopecia areata Phase 2 trial during the remainder of 2021," said Hamza Suria, president and chief executive officer of AnaptysBio. "We believe the recent royalty monetization transaction with Sagard validates the future revenue stream anticipated from JEMPERLI sales and further supports AnaptysBio’s capital-efficient business model."

Imsidolimab (Anti-IL-36 Receptor) Program

Following an end-of-Phase 2 meeting with the FDA in Q2 2021, we publicly disclosed Phase 3 trial designs for imsidolimab in generalized pustular psoriasis (GPP), GEMINI-1 and GEMINI-2. The primary endpoint of our GEMINI-1 Phase 3 trial is the proportion of patients achieving a score of clear (0) or almost clear (1) skin on the Generalized Pustular Psoriasis Physician’s Global Assessment (GPPPGA) at week 4 in 45 patients randomized against placebo. GEMINI-2 will assess 6 months of monthly subcutaneous dosing and safety follow-up of those same patients. GEMINI-1 was initiated in Q3 2021.
Full data from the Phase 2 GALLOP trial in GPP, including efficacy and safety of imsidolimab treatment through week 16, was disclosed in an oral presentation by Dr. Johann Gudjonsson, professor of Dermatology at the University of Michigan, at the European Academy of Dermatology and Venereology (EADV) Congress on October 2nd, 2021. Imsidolimab demonstrated rapid and sustained efficacy with 6 of 8 (75%) GPP patients achieving the primary endpoint at week 4 and 16. We also observed early reduction of erythema with pustules by 60% at week 1, 94% reduction at week 4, 98% reduction at week 16, each versus baseline.
We anticipate top-line data from the ACORN Phase 2 trial of imsidolimab in moderate-to-severe acne in H1 2022 and from the HARP Phase 2 trial in moderate-to-severe hidradenitis suppurativa in H2 2022.
Rosnilimab (Anti-PD-1 Agonist) Program

We anticipate top-line data in Q4 2021 from our ongoing Phase 1 healthy volunteer trial of rosnilimab, our wholly-owned PD-1 agonist antibody, designed to assess the safety, pharmacokinetics and pharmacodynamics of rosnilimab in single and multiple ascending dose cohorts.
We plan to initiate a randomized, placebo-controlled Phase 2 clinical trial of rosnilimab in alopecia areata in Q4 2021.
ANB032 (Anti-BTLA Modulator) Program

We are advancing ANB032, our wholly-owned BTLA modulator antibody, in a healthy volunteer Phase 1 single and multiple ascending dose clinical trial where top-line data is anticipated during the first half of 2022.
GSK Partnered Programs

JEMPERLI (dostarlimab), our proprietary anti-PD-1 antagonist antibody under an immune-oncology partnership with GSK, was approved in a second clinical indication by the FDA in August 2021 for the treatment of pan-deficient mismatch repair tumors. We received $20 million from GSK upon this approval.
We announced the signing of a royalty monetization agreement with Sagard Healthcare Royalty Partners where AnaptysBio will receive a $250 million payment upon closing in exchange for JEMPERLI royalties due to AnaptysBio on annual commercial sales below $1 billion and certain future milestones starting October 2021. The aggregate JEMPERLI royalties and milestones to be received by Sagard under this Agreement is capped at certain fixed multiples of the upfront payment. The closing of the transaction is subject to the satisfaction of customary closing conditions and is anticipated by year-end 2021.
Third Quarter Financial Results

Cash, cash equivalents and investments totaled $389.3 million as of September 30, 2021, compared to $411.2 million as of December 31, 2020, for a decrease of $21.9 million. The decrease relates primarily to cash used for operating activities.
Collaboration revenue was $20.9 million and $62.2 million for the three and nine months ended September 30, 2021. The $20.9 million earned during the third quarter primarily relates to milestone and royalty revenue for the US approval of JEMPERLI (dostarlimab), compared to zero and $15.0 million of milestone revenue for the three and nine months ended September 30, 2020.
Research and development expenses were $22.2 million and $71.7 million for the three and nine months ended September 30, 2021, compared to $19.5 million and $58.5 million for the three and nine months ended September 30, 2020. The increase was due primarily to continued advancement of the Company’s clinical programs.
General and administrative expenses were $5.4 million and $16.1 million for the three and nine months ended September 30, 2021, compared to $4.8 million and $13.8 million for the three and nine months ended September 30, 2020. The increase was due primarily to personnel-related expenses, including share-based compensation.
Net loss was $6.7 million and $25.3 million for the three and nine months ended September 30, 2021, or a net loss per share of $0.24, and $0.92, compared to a net loss of $23.8 million and $53.6 million for the three and nine months ended September 30, 2020, or a net loss per share of $0.87 and $1.96.
Financial Guidance

Following the anticipated closing of the Sagard royalty monetization transaction by the end of 2021, we anticipate ending 2021 with approximately $600 million in cash and will continue to operate in a capital-efficient manner.