On November 9, 2021 FibroGen, Inc. (NASDAQ: FGEN) reported financial results for the third quarter 2021 and provided an update on the Company’s recent developments (Press release, FibroGen, NOV 9, 2021, View Source [SID1234594894]).

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"We and our partner Astellas are excited to be making Evrenzo available to patients in Europe," said Enrique Conterno, Chief Executive Officer, FibroGen. "In addition to continuously looking at opportunities to maximize the value of our portfolio of assets, following the complete response letter for roxadustat in the U.S., we are implementing a comprehensive plan which includes a cost reduction effort that will enable us to focus on our strategic priorities of development of pamrevlumab, roxadustat, and advancing our pipeline."

Recent Key Events and Other Developments

Regulatory:

The European Commission approved EVRENZO (roxadustat) for the treatment of adult patients with symptomatic anemia associated with chronic kidney disease (CKD). Astellas has launched in Germany, the United Kingdom, Netherlands, and Austria.
The U.S. Food and Drug Administration (FDA) issued a complete response letter regarding the New Drug Application (NDA) for roxadustat for the treatment of anemia of CKD.
Clinical:

Announced positive topline results from WHITNEY, the Company’s Phase 2 clinical study of roxadustat, for the treatment of chemotherapy-induced anemia (CIA). The results of the study will be presented at an upcoming medical meeting.
China:

Roxadustat net transfer price from sales to the distribution entity (JDE) jointly owned by FibroGen and AstraZeneca was $19.1 million for the third quarter. From the net transfer price, FibroGen defers a certain portion for revenue recognition purposes under US GAAP. FibroGen reported $13.4 million in roxadustat net product revenue for the quarter.
Total roxadustat net sales in China of $57.8 million by FibroGen and the distribution entity jointly owned by FibroGen and AstraZeneca, compared to $22.7 million in the third quarter of 2020.
Clinical Presentations / Publications:

FibroGen and its partners presented 15 presentations at the American Society of Nephrology (ASN) Kidney Week 2021 Virtual Conference.
One additional roxadustat Phase 3 manuscripts on the treatment of anemia of CKD was published in a peer-reviewed medical journal, bringing the total to 8:
Roxadustat for the Maintenance Treatment of Anemia in Patients with End-Stage Kidney Disease on Stable Dialysis: A European Phase 3, Randomized, Open-Label, Active-Controlled Study (PYRENEES) Advances in Therapy
Upcoming Data Milestones:

Topline data from the Phase 3 MATTERHORN study of roxadustat in anemia of myelodysplastic syndromes (MDS) expected 2H 2022 / 1H 2023.
Interim analysis of event free survival of Phase 3 LAPIS study of pamrevlumab in locally advanced pancreatic cancer (LAPC) expected in 2H 2022.
Topline data from the Phase 3 LELANTOS-1 study of pamrevlumab in non-ambulatory Duchenne muscular dystrophy (DMD) expected 1H 2023.
Topline data from the Phase 3 ZEPHYRUS-1 study of pamrevlumab in idiopathic pulmonary fibrosis (IPF) expected mid-2023.
Corporate

Appointed Juan Graham as Chief Financial Officer.
Implemented a plan to reduce our projected expenses by approximately $100 million per year, for each of the next 3 years.
Financial:

Total revenue for the third quarter of 2021 was $156.0 million, as compared to $44.0 million for the third quarter of 2020. To highlight, current quarter revenue includes $120 million of milestone payments from Astellas related to the EU approval of roxadustat.
Net income for the third quarter of 2021 was $49.8 million, or $0.54 net income per basic and diluted share, compared to a net income of $33.0 million, or $0.36 net income per basic and $0.35 per diluted share one year ago.
At September 30, FibroGen had $665.0 million in cash, cash equivalents, investments, and accounts receivable.
Based on our latest forecast, we estimate our 2021 ending balance of cash, cash equivalents, investments, and accounts receivable to be in the range of $580-610 million.
Conference Call and Webcast Details
FibroGen will host a conference call and webcast today, Tuesday, November 9, 2021, at 5:00 p.m. Eastern Time (2:00 p.m. Pacific Time) to discuss financial results and provide a business update. A live audio webcast of the call may be accessed in the investor section of the Company’s website, www.fibrogen.com. To participate in the conference call by telephone, please dial 1 (877) 658-9081 (U.S. and Canada) or 1 (602) 563-8732 (international), reference the FibroGen third quarter 2021 financial results conference call, and use confirmation number 1747879. A replay of the webcast will be available shortly after the call for a period of 7 days. To access the replay, please dial 1 (855) 859-2056 (domestic) or 1 (404) 537-3406 (international), and use passcode 1747879.

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 also in clinical development for anemia of chronic kidney disease (CKD) and anemia associated with myelodysplastic syndromes (MDS), and for chemotherapy-induced anemia (CIA).

Roxadustat is approved in European Union (EU) member states, including the European Economic Area (EEA) countries, as well as in Japan, China, Chile, and South Korea 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. FibroGen and AstraZeneca are collaborating on the development and commercialization of roxadustat for the potential treatment of anemia in the U.S., China, other markets in the Americas, in Australia/New Zealand, and Southeast Asia.

About Pamrevlumab
Pamrevlumab is a first-in-class antibody developed by FibroGen that inhibits the activity of connective tissue growth factor (CTGF), an important biological mediator in fibrotic and proliferative disorders. Pamrevlumab is in Phase 3 clinical development for the treatment of idiopathic pulmonary fibrosis (IPF), locally advanced unresectable pancreatic cancer (LAPC), and Duchenne muscular dystrophy (DMD). For information about pamrevlumab studies currently recruiting patients, please visit www.clinicaltrials.gov.

On November 9, 2021 Bolt Biotherapeutics, Inc. (NASDAQ: BOLT) a clinical-stage biotechnology company pioneering a new class of immuno-oncology agents that combine the targeting precision of antibodies with the power of both the innate and adaptive immune systems, reported financial results for the third quarter ended September 30, 2021 and provided an update on recent business highlights (Press release, Bolt Biotherapeutics, NOV 9, 2021, View Source [SID1234594893]).

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"This quarter was notable for the significant progress we made across our entire pipeline of novel ISACs and with successful partnering of Bolt’s pioneering technology. We continued robust enrollment of the dose escalation portion of the BDC-1001 Phase 1/2 trial and we anticipate initiation of the combination dose escalation with Opdivo by year-end," said Randall C. Schatzman, Ph.D., Chief Executive Officer of Bolt Biotherapeutics. "We look forward to providing an update on our progress with BDC-1001 at the ESMO (Free ESMO Whitepaper) Immuno-Oncology Congress in December."

Recent Business Highlights and Anticipated Milestones

Progress in the BDC-1001 Phase 1/2 trial in HER2-expressing solid tumors, with a monotherapy interim update in Q4 2021 – Interim data from more than 50 patients treated at increasing exposure levels will be presented in December at the ESMO (Free ESMO Whitepaper) Immuno-Oncology Congress 2021. The presentation will provide further details of the continued favorable safety and tolerability profile along with insights from data on phamacokinetics, tumor and serum biomarkers and early signs of clinical activity. The positive data support continued investigation of an optimal dosing regimen and Phase 2 initiation in 2022.

R&D collaboration with Innovent Biologics to develop up to three anti-cancer ISAC candidates – In August 2021, Bolt Biotherapeutics announced an R&D collaboration to apply Innovent’s proprietary therapeutic antibody portfolio and discovery capability and Bolt’s ISAC platform technology and myeloid biology expertise with the goal of creating up to three new cancer treatments with the potential to provide significant benefit to patients. Bolt Biotherapeutics received an upfront payment of $5.0 million in cash from Innovent at signing and a possible future equity investment of up to $10.0 million, as well as milestones and royalties. Bolt Biotherapeutics retains the option to license global rights outside of Greater China for one program and North American rights for another program.

Clinical collaboration and supply agreement with Bristol Myers Squibb to investigate BDC-1001 in combination with Opdivo (nivolumab) – In September 2021, Bolt Biotherapeutics announced a clinical collaboration and supply agreement with Bristol Myers Squibb Company (BMS) to investigate BDC-1001 in combination with BMS’ PD-1 checkpoint inhibitor Opdivo. BMS will provide Opdivo for the combination dose escalation and combination dose expansion portions of the Phase 1/2 clinical trial in patients with HER2-expressing solid tumors, including breast, gastroesophageal and colorectal. The combination portion of the trial is expected to start in the fourth quarter of 2021.

IND-enabling studies with BDC-2034 (CEA-targeting ISAC) remain on track. GLP toxicology studies are expected to commence in first quarter of 2022 and IND filing in mid-2022.

Cash, cash equivalents, and marketable securities of $290.5 million as of September 30, 2021, plus the $5.0 million upfront payment received in October 2021 for the R&D collaboration with Innovent Biologics, is expected to fund operations and the advancement of the company’s product pipeline to achieve multiple key milestones through the end of 2023.
Upcoming Events

At the 2021 Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting, company scientists will be presenting data on three proprietary, early-stage oncology pipeline programs, including two Boltbody ISAC candidates and a novel agonist antibody targeting Dectin-2 (previously known as TAM1). Information about these presentations can be found below and on the 2021 SITC (Free SITC Whitepaper) Annual Meeting website. All poster presentations will take place from 7:00 a.m. – 8:30 p.m. ET on Saturday, November 13, 2021.
William G. Mallet, Ph.D., will present a poster entitled "BDC-2034: Discovery of a CEA-targeting Immune-Stimulating Antibody Conjugate (ISAC) for Solid Tumors."
Justin A. Kenkel, Ph.D., will present a poster entitled "Dectin-2, a novel target for tumor macrophage reprogramming in cancer immunotherapy."
Marcin Kowanetz, Ph.D., will present a poster entitled "PD-L1-targeted ISAC combines myeloid cell activation, immune-checkpoint inhibition and ADCP to improve anti-tumor efficacy over anti-PD-L1 antibodies in preclinical models."
At the Stifel 2021 Virtual Healthcare Conference, management will participate in a virtual fireside chat and be available for meetings with the investment community on Tuesday, November 16, 2021.
At the ESMO (Free ESMO Whitepaper) Immuno-Oncology Congress 2021, interim results will be presented from the monotherapy dose-escalation portion of a Phase 1/2 study of BDC-1001 for the treatment of patients with advanced HER2-expressing solid tumors, including breast, gastroesophageal and colorectal cancer. ESMO (Free ESMO Whitepaper) I/O is being held in Geneva, Switzerland in person and virtually from December 8-11, 2021.

Title: Preliminary results from a phase 1/2 study of BDC-1001, a novel HER2 targeting TLR7/8 immune-stimulating antibody conjugate (ISAC), in patients (pts) with advanced HER2-expressing solid tumors
Presenter: Manish R. Sharma, M.D., Associate Director of Clinical Research, START Midwest
Presentation Number: 164P
Details: December 8-11, 2021, ePoster presentation
Third Quarter 2021 Financial Results

Cash Position – Cash, cash equivalents, and marketable securities were $290.5 million as of September 30, 2021, compared to $310.9 million as of June 30, 2021. Bolt Biotherapeutics expects this cash balance to fund operations through the end of 2023.

Collaboration Revenue – Revenue was $0.8 million for the quarter ended September 30, 2021, compared to zero for the same quarter in 2020. Revenue in 2021 was generated from services performed under the R&D collaboration with Genmab.

Research and Development Expenses – R&D expenses were $19.3 million for the quarter ended September 30, 2021, compared to $9.5 million for the same quarter in 2020, with the largest two increases due to manufacturing expenses related to BDC-1001 and BDC-2034 and personnel expenses relating to an increase in headcount.

General and Administrative (G&A) Expenses – G&A expenses were $4.9 million for the quarter ended September 30, 2021, compared to $2.9 million for the same quarter in 2020, with the largest increase due to personnel expenses relating to an increase in headcount.

Loss from Operations – Loss from operations was $23.5 million for the quarter ended September 30, 2021, compared to $12.4 million for the same quarter in 2020.

Opdivo is a trademark of Bristol-Myers Squibb Company.

On November 9, 2021 Alkermes plc (Nasdaq: ALKS) announced today that management will participate in a fireside chat at the Stifel Virtual Healthcare Conference on Tuesday, Nov. 16, 2021 at 9:20 a.m. ET (2:20 p.m. GMT) (Press release, Alkermes, NOV 9, 2021, View Source [SID1234594892]). The presentation may be accessed under the Investors tab on www.alkermes.com and will be archived for 14 days.

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On November 9, 2021 Asgard Therapeutics AB ("Asgard"), a private biotech company pioneering in vivo cell reprogramming approaches to elicit potent anti-cancer immune responses, reported the completion of a EUR 6 million seed financing round (Press release, Asgard Therapeutics, NOV 9, 2021, View Source [SID1234594891]). The financing was co-led by Novo Holdings, Boehringer Ingelheim Venture Fund and Industrifonden.

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Asgard is developing a paradigm-shifting cancer immunotherapy approach, based on its proprietary TrojanDC technology, to reinstate cancer immunogenicity. TrojanDC is a gene therapy that reprograms cancer cells into type-1 conventional dendritic cells, allowing the presentation of their own antigens to the immune system, thereby eliciting potent anti-cancer immune responses. Designed as an off-the-shelf gene therapy, TrojanDC induces a personalized immune response, and overcomes many of the logistic and manufacturing hurdles of conventional cell-based therapies.

The Company originated from Lund University’s Cell Reprogramming and Immunity lab, led by Professor Filipe Pereira PhD, who is also Asgard’s Co-Founder and Head of Innovation. Cristiana Pires PhD and Fábio Rosa PhD established the seminal work describing direct reprogramming of somatic cells published in the prestigious science journal Science Immunology .

Cristiana Pires, PhD, Co-Founder and Chief Executive Officer of Asgard Therapeutics, said: "At Asgard, we are committed to surpassing the challenges of current cancer immunotherapies, making them available for every patient. The support we have received from such a strong syndicate of life science investors, is a strong endorsement to the potential of our TrojanDC technology. The financing will enable us to expand our pipeline of preclinical assets and build on our commitment to making personalized cancer immunotherapies optimized to each unique patient."

João Ribas from Novo Seeds commented: "We are very pleased to co-lead this financing and support the translation of the founders’ scientific research at Lund University. While reprogramming approaches have been mainly restricted to regenerative medicine, the work of Filipe, Cristiana and their team opens exciting opportunities to merge the fields of cell reprogramming and cancer immunotherapy that can be applied to several cancers, representing a platform technology with enormous potential. We look forward to working with the Asgard team as they pioneer a new generation of cancer immunotherapy".

Philipp Müller from Boehringer Ingelheim Venture Fund commented: "We are excited to support Asgard Therapeutics and its founder team as co-lead of this seed investment. The seminal work conducted at Lund University by Cristiana Pires, Filipe Pereira, and Fábio Rosa enables the direct conversion of non-related somatic cells into antigen presenting cells with a completely novel cellular identity. We believe this approach holds the potential to significantly impact the way cancer immunotherapy will evolve in the future and to bring new treatment options with true breakthrough potential to cancer patients in need."

Bita Sehat from Industrifonden said: "Asgard’s novel gene therapy approach to reprogram cancer cells into antigen-presenting cells holds great promise to open up new avenues within the immune-oncology space. We are pleased to co-lead this round and look forward to partnering with this strong group of investors and distinguished scientists as the co-founding team to advance what we believe will be a broadly applicable new cancer treatment platform."

Asgard Therapeutics has received support from LU Innovation and several translational grants, including from the Novo Nordisk Foundation, the European Commission’s Horizon 2020 and the Swedish Innovation Agency Vinnova. Asgard Therapeutics is also supported by the BioInnovation Institute in Copenhagen, and a member of the Nordic Mentor Network for Entrepreneurship (NOME) mentoring program. Being a SmiLe incubator company, Asgard is now setting up a new lab at SmiLe, Medicon Village, and will be expanding its research and drug development teams.

As part of the transaction, Søren Møller (Novo Holdings), Philipp Müller (BIVF) and Jonas Jendi (Industrifonden) join current Board Members Filipe Pereira and Lars Hedbys. João Ribas (Novo Holdings) and Fábio Rosa (Asgard Therapeutics) will also join as Board Observers.

On November 9, 2021 Eli Lilly and Company (NYSE: LLY) reported that it will participate in the Wolfe Research Virtual Healthcare Conference on Thursday, Nov. 18, 2021 (Press release, Eli Lilly, NOV 9, 2021, View Source [SID1234594890]). Jacob Van Naarden, CEO of Loxo Oncology at Lilly and president, Lilly Oncology; Mark Mintun, senior vice president, research and development – neuroscience, and president, Avid Radiopharmaceuticals; and David Hyman, M.D., chief medical officer, Lilly Oncology, will participate in a fireside chat at 10:30 a.m., Eastern time .

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A live audio webcast will be available on the "Webcasts & Presentations" section of Lilly’s Investor website at View Source A replay of the presentation will be available on this same website for approximately 90 days.