On February 26, 2024 IN8bio, Inc. (Nasdaq: INAB), a leading clinical-stage biopharmaceutical company focused on innovative gamma-delta T cell therapies, reported that William Ho, CEO and Co-founder, will present at the following investor conferences in March (Press release, In8bio, FEB 26, 2024, View Source [SID1234640453]):

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

TD Cowen 44th Annual Health Care Conference
Company presentation
Monday, March 4, 2024, at 9:50 am ET

2nd Annual H.C. Wainwright Cell Therapy Virtual Conference
Virtual company presentation
Tuesday, March 26, 2024

A live webcast and replay will be available under "Events and Presentations" in the News & Presentations section of the IN8bio website at View Source

On February 26, 2024 iBio, Inc. (NYSEA:IBIO) ("iBio" or the "Company"), an AI-driven innovator of precision antibody immunotherapies, reported that it has entered into an asset purchase agreement ("Agreement") with Otsuka Pharmaceutical Co., Ltd. ("Otsuka"), pursuant to which Otsuka acquired iBio’s assets related to its early-stage programmed cell death protein 1 ("PD-1" ) agonist program (Press release, iBioPharma, FEB 26, 2024, View Source [SID1234640452]). The transaction closed on February 25, 2024.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Under the terms of the Agreement, iBio will receive an upfront payment of $1.0 million in cash at closing. iBio will also be eligible to receive additional contingent cash payments totaling up to $52.5 million upon the achievement of certain pre-specified clinical development and commercial milestones.

PD-1 is a pivotal checkpoint in the immune system, acting as a type of "off switch" that helps keep the cells from attacking other cells in the body. By agonizing or enhancing the signaling of PD-1, it is possible to temper the immune response, making it particularly valuable in the treatment of autoimmune diseases. In conditions where the immune system mistakenly wages war on the body’s own cells, such as in autoimmune diabetes or lupus, therapies that target PD-1 can potentially reduce the severity of these autoimmune reactions. However, unlike PD-1 antagonists used in immuno-oncology, PD-1 agonists, like the one iBio is selling to Otsuka, are difficult to find.

"We believe this is an important transaction for iBio, and a win-win for both companies," said iBio’s Chief Executive Officer and Chief Scientific Officer, Martin Brenner, DVM, Ph.D. "The deal provides iBio with a potential significant new source of non-dilutive capital if all of the milestones are satisfied; further validates the ability of our precision-driven and deeply integrated technology stack to efficiently deliver antibody candidates against challenging targets, including the development of complex antibody modalities such as agonistic antibodies; and allows us to focus our resources squarely on the continued development of our proprietary immuno-oncology pipeline and AI-based drug discovery platform. At the same time, it provides a path forward for the PD-1 agonist program via further development by Otsuka."

On February 26, 2024 GlycoMimetics, Inc. (Nasdaq: GLYC) reported that Harout Semerjian, Chief Executive Officer, will participate in the Leukemia Panel at the Cowen 44th Annual Health Care Conference in Boston, MA on Monday, March 4, 2024 at 12:50 p.m. ET (Press release, GlycoMimetics, FEB 26, 2024, View Source [SID1234640451]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

A live webcast of the panel presentation will be available on the GlycoMimetics website at View Source An archived recording will be available for 30 days following the event.

On February 26, 2024 FibroGen, Inc. (NASDAQ: FGEN) reported financial results for the fourth quarter and full year 2023 and provided an update on the company’s recent developments (Press release, FibroGen, FEB 26, 2024, View Source [SID1234640449]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"We are extremely excited about the company’s prospects in 2024," said Thane Wettig, Chief Executive Officer, FibroGen. "In this year alone, we will obtain data read-outs from our two late-stage pancreatic cancer trials, start a Phase 2 metastatic castration-resistant prostate cancer trial, file an immuno-oncology IND, and potentially receive approval for roxadustat in chemotherapy-induced anemia in China. Furthermore, the continued strength of our China business, accelerated realization of our corporate cost reduction program, and our strong balance sheet provide us a cash runway into 2026. These unique and exciting programs, combined with the quality of our talented colleagues, provide a strong foundation to create significant value for shareholders relative to our current valuation."

Upcoming Milestones:

Pamrevlumab

Topline data from the PanCAN Precision Promise℠ Phase 2/3 study of pamrevlumab in metastatic pancreatic cancer expected in 2Q 2024.
Topline data from the LAPIS Phase 3 study of pamrevlumab in locally advanced unresectable pancreatic cancer (LAPC) expected in 2Q 2024.
Roxadustat

Expect approval decision for roxadustat in chemotherapy-induced anemia (CIA) in China in mid-2024. If approved, FibroGen will receive a $10M milestone payment from AstraZeneca.
Oncology Pipeline

Additional data from Phase 1 monotherapy study of FG-3246 in metastatic castration-resistant prostate cancer (mCRPC) expected in 1Q 2024.
Anticipate the initiation of a Phase 2 study of FG-3246 in mCRPC in 2H 2024.
Anticipate the filing of two INDs: FG-3165 (anti-Gal9 antibody) in 1Q 2024 and FG-3175 (anti-CCR8 antibody) in 2025.
Recent Developments and Key Highlights of 2023:

Pamrevlumab

Announced graduation and completion of the pamrevlumab arm in Precision Promise℠, Pancreatic Cancer Action Network’s Phase 2/3 adaptive platform trial for metastatic pancreatic cancer.
Pamrevlumab, in Stage 1 of the trial, achieved a protocol pre-specified ≥ 35% predictive probability of success for the primary endpoint of overall survival at the completion of the trial.
Roxadustat

Regained all rights to roxadustat from AstraZeneca in the United States and other AstraZeneca territories, except China and South Korea.
Presented data from Phase 3 MATTERHORN study of roxadustat in patients with anemia of lower risk transfusion-dependent myelodysplastic syndromes at American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting.
Corporate

Thane Wettig appointed Chief Executive Officer.
Successful execution of cost reduction plan, resulting in a reduction of total annualized expenses of $120 million.
China:

Fourth quarter FibroGen’s net product revenue under U.S. GAAP from the sale of roxadustat in China was $23.5 million compared to $23.4 million in the fourth quarter of 2022.
Full year 2023 FibroGen’s net product revenue under U.S. GAAP from the sale of roxadustat in China was $100.9 million compared to $82.9 million in the full year 2022, an increase of 22%.
Fourth quarter total roxadustat net sales in China¹ by FibroGen and the distribution entity jointly owned by FibroGen and AstraZeneca (JDE) was $66.5 million, compared to $53.1 million in the fourth quarter of 2022, an increase of 25%.
Full year 2023 total roxadustat net sales in China¹ by FibroGen and the JDE was $284.1 million, compared to $208.8 million in the full year 2022, an increase of 36%, driven by over 41% growth in volume.
Roxadustat continues to be the number one brand based on value share in the anemia of CKD market in China and has secured renewal on the National Reimbursement Drug List.
For 2024, we anticipate FibroGen’s full year net product revenue under U.S. GAAP to range between $120 million to $135 million, representing full year roxadustat net sales in China¹ by FibroGen and the JDE to range between $300 million to $340 million.
Financial:

Total revenue for the fourth quarter of 2023 was $27.1 million, as compared to $34.4 million for the fourth quarter of 2022. Reduction primarily driven by the change in net product revenue assumptions under U.S. GAAP and drug product revenue shipment timing.
Total revenue for full year 2023 was $147.8 million as compared to $140.7 million in 2022.
Net loss for the fourth quarter of 2023 was $56.2 million, or $0.57 net loss per basic and diluted share, compared to a net loss of $66.2 million, or $0.70 net loss per basic and diluted share one year ago.
Net loss for the year was $284.2 million, or $2.92 net loss per basic and diluted share, compared to a net loss of $293.7 million, or $3.14 net loss per basic and diluted share one year ago.
At December 31, 2023, FibroGen had $248.1 million in cash – defined as cash, cash equivalents, investments, and accounts receivable.
We expect our cash, cash equivalents, investments, and accounts receivable to be sufficient to fund our operating plans into 2026.
Conference Call and Webcast Details

FibroGen will host a conference call and webcast today, Monday, February 26, 2024, at 5:00 PM Eastern Time to discuss financial results and provide a business update. Interested parties may access a live audio webcast of the conference call via the "Investor Relations" page of the Company’s website at www.fibrogen.com. To access the call by phone, please go to this link (registration link), and you will be provided with dial in details. To avoid delays, we encourage participants to dial into the conference call fifteen minutes ahead of the scheduled start time. A replay of the webcast will also be available for a limited time at the following link (webcast replay).

About Pamrevlumab

Pamrevlumab is a potential first-in-class antibody being developed by FibroGen to inhibit the activity of connective tissue growth factor (CTGF). Pamrevlumab is in Phase 3 clinical development for the treatment of locally advanced unresectable pancreatic cancer (LAPC) and in Phase 2/3 for the treatment of metastatic pancreatic cancer. The U.S. Food and Drug Administration has granted Orphan Drug Designation, and Fast Track designation to pamrevlumab for the treatment of patients with LAPC. Pamrevlumab has demonstrated a safety and tolerability profile that has supported ongoing clinical investigation in LAPC and metastatic pancreatic cancer. Pamrevlumab is an investigational drug and not approved for marketing by any regulatory authority. For information about our pamrevlumab studies please visit www.clinicaltrials.gov.

About Roxadustat

Roxadustat, an oral medication, is the first in a new class of medicines comprising HIF-PH inhibitors that promote erythropoiesis, or red blood cell production, through increased endogenous production of erythropoietin, improved iron absorption and mobilization, and downregulation of hepcidin. Roxadustat is in clinical development for chemotherapy-induced anemia (CIA) and a Supplemental New Drug Application (sNDA) has been accepted by the China Health Authority.

Roxadustat is approved in China, Europe, Japan, and numerous other countries for the treatment of anemia of CKD in adult patients on dialysis (DD) and not on dialysis (NDD). Several other licensing applications for roxadustat have been submitted by partners, Astellas and AstraZeneca, to regulatory authorities across the globe, and are currently under review. Astellas and FibroGen are collaborating on the development and commercialization of roxadustat for the potential treatment of anemia in territories including Japan, Europe, Turkey, Russia, and the Commonwealth of Independent States, the Middle East, and South Africa. AstraZeneca and FibroGen continue to collaborate on the development and commercialization of roxadustat in China.

On February 26, 2024 Fate Therapeutics, Inc. (NASDAQ: FATE), a clinical-stage biopharmaceutical company dedicated to bringing a first-in-class pipeline of induced pluripotent stem cell (iPSC)-derived cellular immunotherapies to patients with cancer and autoimmune disorders, reported business highlights and financial results for the fourth quarter and full year ended December 31, 2023 (Press release, Fate Therapeutics, FEB 26, 2024, View Source [SID1234640448]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"We have started the year with strong momentum across our iPSC product platform in oncology and autoimmunity, including the award of a grant by the California Institute of Regenerative Medicine to support Phase 1 clinical investigation of our off-the-shelf FT819 CAR T-cell program in systemic lupus erythematosus," said Scott Wolchko, President and Chief Executive Officer of Fate Therapeutics. "We have also treated the first patient with FT522, our off-the-shelf CAR NK cell program targeting CD19+ B cells, which is our first product candidate to incorporate our proprietary Alloimmune Defense Receptor technology that is designed to reduce or eliminate the need for administration of intense chemotherapy conditioning to patients. In addition, we have initiated the Phase 1 study of our FT825 / ONO-8250 CAR T-cell program in solid tumors, which incorporates seven synthetic controls of cell function including a novel cancer-specific binding domain targeting HER2. We are well positioned to generate initial clinical data across these off-the-shelf programs during 2024."

FT819 iPSC-derived CAR T-cell Program

CLIN2 Grant Awarded by CIRM to Fund FT819 Phase 1 Autoimmunity Study in SLE. In February, the Company was awarded $7.9 million by the California Institute for Regenerative Medicine (CIRM) to support clinical investigation of FT819 in patients with systemic lupus erythematosus (SLE). FT819 is the Company’s off-the-shelf CAR T-cell product candidate that incorporates several novel synthetic controls of cell function, including the integration of a novel CD19-targeted 1XX chimeric antigen receptor (CAR) construct into the T-cell receptor alpha constant (TRAC) locus that is intended to promote uniform CAR expression, enhance T-cell potency, and prevent graft-versus-host disease (GvHD). The multi-center, Phase 1 clinical trial for SLE is designed to evaluate the safety, pharmacokinetics, and anti-B-cell activity of a single dose of FT819 administered following a standard three-day chemotherapy conditioning regimen. The Company is currently conducting study start-up activities at multiple U.S. clinical sites.
Dose Escalation Ongoing in Phase 1 Study for B-cell Lymphoma. The Company’s landmark clinical trial of FT819 for the treatment of relapsed / refractory B-cell malignancies is the first-ever clinical investigation of a T-cell product candidate manufactured from a clonal master iPSC line. The Company is currently enrolling patients in single-dose treatment cohorts at 540 million cells and at 1.08 billion cells using a standard three-day chemotherapy conditioning regimen. Any further clinical development of FT819 for the treatment of B-cell malignancies will be determined by the Company based on safety and activity at these higher dose levels. Clinical data previously presented by the Company from the first 11 patients with relapsed / refractory B-cell lymphoma treated with a single dose of FT819 at up to 360 million cells showed anti-tumor activity including three complete responses and one partial response, CAR T-cell expansion that peaked in the peripheral blood between Days 8 and 11, and a favorable safety profile with no dose-limiting toxicities, no events of any grade of immune effector-cell associated neurotoxicity syndrome (ICANS) or GvHD, and no events of Grade 3 or greater cytokine release syndrome (CRS).
FT825 / ONO-8250 iPSC-derived CAR T-cell Program

Phase 1 Study Initiated with HER2-targeted CAR T-cell for Advanced Solid Tumors. In January, the Company initiated enrollment of a multi-center, Phase 1 clinical trial of FT825 / ONO-8250 under its collaboration with Ono Pharmaceutical Co., Ltd. (Ono). Designed using the Company’s iPSC product platform, FT825 / ONO-8250 incorporates seven synthetic controls of cell function including a novel cancer-specific H2CasMab-2 CAR targeting human epidermal growth factor receptor 2 (HER2). Preclinical data of FT825 / ONO-8250 presented at the 2023 Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting demonstrated that the profile of its novel HER2-targeted antigen binding domain is unique and differentiated from that of trastuzumab, exhibiting similar potency with greater specificity for cancer cells expressing HER2. The Phase 1 study is designed to assess the safety, pharmacokinetics, and activity of a single dose of FT825 / ONO-8250 as monotherapy and in combination with monoclonal antibody therapy in patients with advanced solid tumors.
FT522 iPSC-derived CAR NK Cell Program

First Patient Treated with ADR-armed, CD19-targeted CAR NK Cell Product Candidate. FT522 is the Company’s first product candidate incorporating its proprietary Alloimmune Defense Receptor (ADR) technology, which is designed to reduce or eliminate the need for administration of intense chemotherapy conditioning to patients receiving cell therapies. The multi-center, Phase 1 clinical trial of FT522 in patients with relapsed / refractory B-cell lymphoma is currently enrolling patients in the first three-dose cohort at 300 million cells per dose of Regimen A, which includes administration of chemotherapy conditioning. Subject to clearance of dose-limiting toxicities at this first dose level of Regimen A, enrollment is expected to commence in the first three-dose cohort at 300 million cells per dose of Regimen B without administration of chemotherapy conditioning.
Preclinical Studies Ongoing to Support Expansion into Autoimmunity. The Company is conducting a preclinical assessment of the potential for FT522 to induce CD19+ B-cell depletion across a range of autoimmune diseases, including without administration of intense chemotherapy conditioning to patients. In a disseminated Nalm6 leukemia model comprised of CD19+ target cells resistant to T-cell killing, ADR-armed, CD19-targeted CAR NK cells exhibited robust killing in vivo of CD19+ target cells in the presence of alloreactive T cells, suggesting that FT522 has the potential to deplete CD19+ B cells without administration of intense chemotherapy conditioning to patients. Additional preclinical studies are ongoing with FT522 in combination with monoclonal antibody therapy to assess the potential depletion of both CD19+ B-cell and CD38+ plasma-cell autoantibody-producing lineages.
FT576 iPSC-derived CAR NK Cell Program

Dose Escalation Ongoing in Phase 1 Multiple Myeloma Study. The Company’s multi-center, Phase 1 clinical trial of FT576, its BCMA-targeted CAR NK cell product candidate, is currently accruing patients with relapsed / refractory multiple myeloma in three-dose treatment cohorts as monotherapy as well as in combination with CD38-targeted monoclonal antibody. Using a standard three-day chemotherapy conditioning regimen, the Company has treated six patients at 1 billion cells per dose, with no dose-limiting toxicities and no reports of any grade of CRS, ICANS or GvHD. The study is currently enrolling patients at 2.5 billion cells per dose. Any further clinical development of FT576 for the treatment of multiple myeloma will be determined by the Company based on safety and activity at these higher dose levels.
Fourth Quarter 2023 Financial Results

Cash & Investment Position: Cash, cash equivalents and investments as of December 31, 2023 were $316.2 million.
Total Revenue: Revenue was $1.7 million for the fourth quarter of 2023, which was derived from the Company’s conduct of preclinical development activities for a second collaboration candidate targeting an undisclosed solid tumor antigen under its collaboration with Ono.
Total Operating Expenses: For the fourth quarter of 2023, GAAP operating expenses were $49.8 million, including research and development expenses of $31.8 million and general and administrative expenses of $17.9 million. Such amounts included $9.5 million of non-cash stock-based compensation expense.
Shares Outstanding: Common shares outstanding were 98.6 million, and preferred shares outstanding were 2.8 million, as of December 31, 2023. Each preferred share is convertible into five common shares.
Today’s Conference Call and Webcast
The Company will conduct a conference call today, Monday, February 26, 2024 at 5:00 p.m. ET to review financial and operating results for the quarter and full year ended December 31, 2023. In order to participate in the conference call, please register using the conference link here. The live webcast can be accessed under "Events & Presentations" in the Investors section of the Company’s website at www.fatetherapeutics.com. The archived webcast will be available on the Company’s website beginning approximately two hours after the event.