On November 6, 2023 Immix Biopharma, Inc. (Nasdaq: IMMX) ("ImmixBio", "Company", "We" or "Us"), a clinical-stage biopharmaceutical company pioneering personalized therapies for oncology and immunology, reported that updated NXC-201 relapsed/refractory multiple myeloma clinical data has been selected for presentation at the upcoming 65th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting to be held in San Diego, California, December 9-12, 2023 (Press release, Immix Biopharma, NOV 6, 2023, View Source [SID1234637028]).

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"75% of patients on multiple myeloma CAR-T waiting lists at U.S. hospitals do not receive the CAR-T therapy. As CAR-Ts are expected to be approved for earlier lines of treatment, we believe demand is likely to increase," said Ilya Rachman, MD PhD, Chief Executive Officer of Immix Biopharma. "We are working tirelessly to make NXC-201 an option for these patients waiting for multiple myeloma CAR-Ts."

"Today, only 5% of U.S. hospitals offer multiple myeloma CAR-Ts due to toxicities," said Gabriel Morris, Chief Financial Officer of Immix Biopharma. "Our N-GENIUS technology platform, which we believe overcomes neurotoxicity, aims to allow the remaining 95% of U.S. hospitals, including community hospitals, to offer our CAR-T NXC-201."

ASH Presentation Details (NXC-201 Multiple Myeloma):

Event 65th ASH (Free ASH Whitepaper) Annual Meeting and Exposition, San Diego, CA
Title "Safety and Efficacy of a Locally Produced Novel Anti-BCMA Chimeric Antigen Receptor T-Cell (CART) (HBI0101) for the Treatment of Relapsed and Refractory Multiple Myeloma"
Presentation
Date/Time (Pacific Time)
Publication #4852
Session Date: Monday, December 11, 2023
Session Name: 704. Cellular Immunotherapies: Early Phase and Investigational Therapies: Poster III
Session Time: 6:00 PM – 8:00 PM
Presentation Time: San Diego Convention Center, Halls G-H
About NXC-201

NXC-201 (formerly HBI0101) is a BCMA-targeted investigational chimeric antigen receptor T (CAR-T) cell therapy that is being studied in a comprehensive clinical development program for the treatment of patients with relapsed/refractory AL amyloidosis and relapsed/refractory multiple myeloma.

About NEXICART-1

NEXICART-1 (NCT04720313) is an ongoing Phase 1b/2a, open-label study evaluating the safety and efficacy of NXC-201 (formerly HBI0101), in adults with relapsed/refractory multiple myeloma and relapsed/refractory AL amyloidosis.

The primary objective of the Phase 1b portion of the study was to characterize the safety and confirm the recommended Phase 2 dose (RP2D) and Phase 2 dose of NXC-201. The Phase 2 portion of the study will evaluate the efficacy and safety of NXC-201 in relapsed/refractory Multiple Myeloma according to the International Myeloma Working Group (IMWG) Uniform Response Criteria and in relapsed/refractory AL Amyloidosis according to consensus recommendations.

The Phase 1b portion of the ongoing Phase 1b/2a clinical trial has been successful in determining the recommended Phase 2 dose (RP2D) of 800 million CAR+T cells. ImmixBio plans to submit an IND application to the FDA for a Phase 1b/2 of NXC-201 in relapsed/refractory multiple myeloma and relapsed/refractory AL amyloidosis in order to expand the ongoing clinical trial to the U.S. The expected primary endpoint for the Phase 2 portion of the ongoing Phase 1b/2a clinical trial of NXC-201 in relapsed/refractory multiple myeloma is overall response rate and duration of response. ImmixBio plans to submit data to the FDA in relapsed/refractory multiple myeloma once 100 patients are treated with NXC-201. The expected primary endpoint for NXC-201 in relapsed/refractory AL Amyloidosis is overall response rate. ImmixBio plans to submit data to the FDA in relapsed/refractory AL amyloidosis once 30-40 patients are treated with NXC-201.

About Multiple Myeloma

Multiple myeloma ("MM") is an incurable blood cancer of plasma cells that starts in the bone marrow and is characterized by an excessive proliferation of these cells. Despite initial remission, unfortunately, most patients are likely to relapse. There are 35,730 patients in the United States diagnosed with MM each year. Prognosis for patients who do not respond to or relapse after treatment with standard therapies, including protease inhibitors and immunomodulatory agents remains poor. The $13.9 billion Multiple Myeloma market in 2017 is expected to reach $28.7 billion in 2027 according to Wilcock, et al. Nature Reviews.

On November 6, 2023 Halozyme Therapeutics, Inc. (NASDAQ: HALO) ("Halozyme" or the "Company") reported its financial and operating results for the third quarter ended September 30, 2023 and provided an update on its recent corporate activities and outlook (Press release, Halozyme, NOV 6, 2023, View Source [SID1234637027]).

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"I am delighted that our strong operating performance and expense management throughout the year have resulted in an increase to EBITDA and non-GAAP EPS guidance. Today, we also announced an acceleration into this year of the remaining $250 million under the current approved $750 million share repurchase plan, authorized in 2021. This action is part of our disciplined and balanced approach to capital allocation and reflects our assessment that share repurchases today are a strong return on investment opportunity," said Helen Torley, president and CEO of Halozyme. "Supporting our conviction in long-term revenue growth and durability, the third quarter was remarkable, with multiple, meaningful, de-risking events and progress for our upcoming series of Wave 3 potential product launches, projected for 2023-2025. I am also pleased with the progress in the quarter in advancing discussions on development of our HVAI."

Recent Corporate Highlights:
•Announced an acceleration, into this year, of the remaining $250 million under the current approved $750 million share repurchase plan authorized in 2021. The Company intends to execute the $250 million share repurchase by entering into an accelerated share repurchase ("ASR") transaction with a financial Institution, immediately, subject to market conditions.
•In August 2023, the Company announced positive results of a clinical study with its high-volume auto-injector demonstrating SC administration of 10 mL of a representative biologic product co-formulated with our ENHANZE drug delivery technology in approximately 30 seconds. The results were presented at the 13th annual Partnership Opportunities in Drug Delivery ("PODD") conference in October 2023.

Recent Partner Highlights:

•In November 2023, Halozyme and Acumen entered into a global collaboration and non-exclusive license agreement that provides Acumen access to ENHANZE technology for a single target. Acumen intends to explore the potential use of ENHANZE for ACU193, Acumen’s clinical stage monoclonal antibody candidate to target Amyloid-β Oligomers for the treatment of early Alzheimer’s disease.
•In October 2023, Bristol Myers Squibb reported positive topline results from the Phase 3 CheckMate-67T trial evaluating a SC formulation of Opdivo (nivolumab) with ENHANZE in patients with advanced or metastatic clear cell renal cell carcinoma ("ccRCC") who have received prior systemic therapy. The study met its co-primary pharmacokinetics ("PK") endpoints and a key secondary endpoint.
•In September 2023, Chugai Pharmaceuticals, a member of the Roche Group, announced that it had obtained regulatory approval for Phesgo from the Ministry of Health, Labour and Welfare ("MHLW") in Japan. Halozyme is entitled to receive royalties for Phesgo sales in Japan under its agreement with Roche.
•In September 2023, argenx announced the Committee for Medicinal Products for Human Use ("CHMP") of the European Medicines Agency ("EMA") has recommended European Commission ("EC") approval of the SC injectable formulation of efgartigimod as an add on to standard therapy for the treatment of adult patients with generalized myasthenia gravis ("gMG") who are anti-acetylcholine receptor ("AChR") antibody positive. The EC is expected to make a decision on the argenx marketing authorization application within approximately 67 days following the CHMP recommendation.
•In September 2023, Zai Lab limited (argenx commercial partner for China) announced the Center for Drug Evaluation ("CDE") of the National Medical Products Administration ("NMPA") granted Breakthrough Therapy Designation for efgartigimod alfa injection (SC injection) (efgartigimod SC) for the treatment of patients with chronic inflammatory demyelinating polyneuropathy ("CIDP"). The Breakthrough Therapy Designation for efgartigimod SC was supported by data from both global and Chinese patients enrolled in the ADHERE study.
•In September 2023, Roche informed the Company that there will be a delay in the projected launch timing for Tecentriq SC in the U.S. as a result of Roche’s need to update chemistry, manufacturing, and controls ("CMC") processes for Tecentriq SC. Roche expects these updates to be completed in 2023 to support a potential launch of Tecentriq SC in the U.S. in 2024. There is no expected impact on ex-U.S. filings for Tecentriq SC.
•In August 2023, Roche announced the approval of Tecentriq SC with ENHANZE by the Medicines and Healthcare products Regulatory Agency ("MHRA") in Great Britain, triggering an $8.0 million milestone payment to Halozyme and the right to receive royalties on net product sales.
•In August 2023, ViiV initiated a Phase 2b study to evaluate the efficacy, safety, PK and tolerability of VH3810109 (N6LS) administered subcutaneously with ENHANZE in combination with cabotegravir.
•In August 2023, ViiV achieved a development milestone, which triggered a $5 million milestone payment to Halozyme.
•In July 2023, argenx reported positive data from the ADHERE study evaluating VYVGART Hytrulo with ENHANZE in adults with CIDP. The study met its primary endpoint resulting in a 61% reduction in risk of relapse compared to placebo.
•In July 2023, Roche announced that the Phase III OCARINA II trial evaluating OCREVUS (ocrelizumab) with ENHANZE as a twice a year 10-minute SC injection met its primary and secondary endpoints in patients with relapsing forms of multiple sclerosis ("MS") or primary progressive MS ("RMS" or "PPMS").

Third Quarter 2023 Financial Highlights:
•Revenue was $216.0 million compared to $209.0 million in the third quarter of 2022. The 3% year-over-year increase was driven by growth in ENHANZE revenue streams with an increase in royalty revenue and an increase in product sales as a result of an increase in bulk rHuPH20 sales driven by partner demand and continued growth in XYOSTED, partially offset by in the timing of milestone revenue. Revenue for the quarter included $114.4 million in royalties, an increase of 15% compared to $99.6 million in the prior year period, primarily attributable to increases in revenue of subcutaneous DARZALEX (daratumumab) and Phesgo.
•Cost of sales was $54.8 million, compared to $47.3 million in the third quarter of 2022. The increase was driven by growth in proprietary product sales and bulk rHuPH20 demand.
•Amortization of intangibles expense was $20.3 million, compared to $27.2 million in the third quarter of 2022. The decrease was due to a remeasurement period adjustment of our acquired intangible assets recorded in the fourth quarter of 2022, partially offset by an impairment charge of $2.5 million to fully impair the TLANDO product rights intangible asset as a result of the license agreement termination notice provided to Lipocine in September 2023.
•Research and development expense was $17.3 million, compared to $16.7 million in the third quarter of 2022. Selling, general and administrative expense was $35.3 million, compared to $34.5 million in the third quarter of 2022. The increases were primarily due to an increase in compensation expense.
•Operating income was $88.3 million, compared to operating income of $83.3 million in the third quarter of 2022.
•Net Income was $81.8 million, compared with net income of $61.6 million in the third quarter of 2022.
•EBITDA was $124.6 million, compared with EBITDA of $109.8 million in the third quarter of 2022. Adjusted EBITDA was $114.9 million, compared with Adjusted EBITDA of $110.2 million in the third quarter of 2022.1
•Earnings per Share: GAAP diluted earnings per share was $0.61, compared with $0.44 in the third quarter of 2022. Non-GAAP diluted earnings per share was $0.75, compared with $0.74 in the third quarter of 2022.1
•Cash, cash equivalents and marketable securities were $483.3 million on September 30, 2023, compared to $362.8 million on December 31, 2022. The increase was primarily due to the cash provided by operating activities, partially offset by repurchase of common stock for $150.0 million in the first quarter of 2023.

Financial Outlook for 2023

The Company is raising its EBITDA and non-GAAP EPS guidance ranges to reflect strong expense management. For the full year 2023, the Company now expects:

•Total revenue of $825 million to $845 million, representing growth of 25% to 28% over 2022 total revenue primarily driven by continued strength in Wave 2 products, including DARZALEX SC and Phesgo utilizing ENHANZE, as well as full year auto-injector royalty and product contribution. The Company expects revenue from royalties of $445 million to $455 million, representing growth of 23% to 26%.
•EBITDA of $430 million to $445 million, representing growth of >30% over 2022. EBITDA excludes the impact of amortization costs related to the Antares Pharma acquisition.1
•Non-GAAP diluted earnings per share of $2.70 to $2.80, representing growth of 22% over 2022.1 The Company’s earnings per share guidance does not consider the impact of potential future share repurchases.

On November 6, 2023 Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company focused on helping conquer cancer globally through use of its proprietary tests, vast data sets and advanced analytics, reported financial results for the quarter ended September 30, 2023 (Press release, Guardant Health, NOV 6, 2023, View Source [SID1234637026]).

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Third Quarter 2023 Financial Highlights
•Revenue of $143.0 million for the third quarter of 2023, an increase of 22% over the third quarter of 2022
•Reported 43,900 tests to clinical customers and 7,500 tests to biopharmaceutical customers in the third quarter of 2023, representing increases of 35% and 11%, respectively, over the third quarter of 2022

Recent Operating Highlights

•Presented first results of the PEGASUS MRD de-escalation trial at the European Society for Medical Oncology, ESMO (Free ESMO Whitepaper), with data suggesting Guardant Reveal may help guide adjuvant treatment of colon cancer
•Received coverage for Guardant Reveal from Geisinger Health Plan
•Surpassed 200 million covered lives for TissueNext
•Launched Guardant360 for clinical use in Japan and biopharma use in China
•Received regulatory approval in Japan for Guardant360 CDx as a companion diagnostic to ENHERTU for treatment of non-small cell lung cancer patients with HER2 mutations
•Published the first paper for Shield demonstrating utility of blood-based CRC screening in Annals of Oncology
"We ended the third quarter with revenue growth of 22%, driven by strong year-over-year growth in clinical volume. We are starting to see the impact of coverage decisions on Guardant360, with uplifts in ASPs and additional tailwinds further strengthening the financial profile of our Therapy Selection business," said Helmy Eltoukhy, co-founder and co-CEO. "We recently presented exciting MRD data, further demonstrating the clinical utility of our Reveal blood test. We look forward to a strong finish to the year."
"We are continuing to make steady progress in our screening business with our Shield blood test," said AmirAli Talasaz, co-founder and co-CEO. "At our recent investor day, we shared some promising new clinical validation data on the next generation of our Shield test. We are also advancing our progress in lung and other indications as we develop Shield into a multi-cancer early detection test."
Third Quarter 2023 Financial Results
Revenue was $143.0 million for the three months ended September 30, 2023, a 22% increase from $117.4 million for the three months ended September 30, 2022. Precision oncology revenue grew 31%, driven predominantly by an increase in clinical testing volume and biopharma sample volume, which grew 35% and 11%, respectively, over the prior year period. In addition, our clinical testing revenue for the three months ended September 30, 2023 includes a payment of $3.6 million from Medicare related to a successful appeal for claims dated between 2018 and 2020. Development services and other revenue decreased by 37%, primarily due to the timing and amount of milestones related to our partnership agreements and companion diagnostics collaboration projects with biopharmaceutical customers, as well as a reduction in royalty revenue during the three months ended September 30, 2023.
Gross profit, or total revenue less cost of precision oncology testing and cost of development services and other, was $85.4 million for the third quarter of 2023, an increase of $8.5 million from $76.9 million for the corresponding prior year period. Gross margin, or gross profit divided by total revenue, was 60%, as compared to 66% for the corresponding prior year period. Precision oncology gross margin was 60% in the third quarter of 2023, as compared to 61% in the prior year period. The reduction is primarily due to changes in product mix. Development services and other gross margin was 59% in the third quarter of 2023, as compared to 93% in the prior year period. The change is primarily due to the inclusion of the cost of processing Shield LDT samples as part of our screening market development activities, for which we are currently booking minimal revenue.
Operating expenses were $199.0 million for the third quarter of 2023, as compared to $221.5 million for the corresponding prior year period. Non-GAAP operating expenses were $177.3 million for the third quarter of 2023, as compared to $200.5 million for the corresponding prior year period.

Net loss was $86.1 million for the third quarter of 2023, as compared to $162.0 million for the corresponding prior year period. Net loss per share was $0.73 for the third quarter of 2023, as compared to $1.58 for the corresponding prior year period. The year-over-year reduction in net loss is primarily due to a $31.1 million year-over-year improvement in our loss from operations, a $29.9 million positive change in unrealized gains and losses, and a $9.9 million increase in interest income.
Non-GAAP net loss was $79.2 million for the third quarter of 2023, as compared to $120.8 million for the corresponding prior year period. Non-GAAP net loss per share was $0.67 for the third quarter of 2023, as compared to $1.18 for the corresponding prior year period.
Adjusted EBITDA loss was $79.7 million for the third quarter of 2023, as compared to a $112.8 million loss for the corresponding prior year period.
Free cash flow for the third quarter of 2023 was negative $80.2 million. Cash, cash equivalents and marketable debt securities were $1.2 billion as of September 30, 2023.
2023 Guidance
Guardant Health now expects full year 2023 revenue to be in the range of $553 to $556 million, representing growth of 23% to 24% compared to full year 2022. Guardant Health continues to expect full year 2023 operating expenses to be below full year 2022, driven by efficiency measures and continued leverage of its existing infrastructure, and free cash flow to be approximately negative $350 million in 2023.
Webcast Information
Guardant Health will host a conference call to discuss the third quarter and full year 2023 financial results after market close on Monday, November 6, 2023 at 1:30 pm Pacific Time / 4:30 pm Eastern Time. A webcast of the conference call can be accessed at View Source The webcast will be archived and available for replay for at least 90 days after the event.

On November 6, 2023 GT Biopharma, Inc. (NASDAQ: GTBP), a clinical stage immuno-oncology company focused on developing innovative therapeutics based on the Company’s proprietary natural killer (NK) cell engager, TriKE platform, reported positive preclinical data in highlighting GTB-5550’s potential in prostate cancer (Press release, GT Biopharma, NOV 6, 2023, View Source [SID1234637025]). Martin Felices, PhD, Associate Professor of Medicine at the University of Minnesota, presented these data on Saturday, November 4th at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting 2023, which is being held in San Diego, California November 1-5.

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Natural killer (NK) cells are being increasingly explored in clinical trials due to their safety profile and ability to mediate tumor killing without prior priming. However, lack of antigen-specific targeting, decreased numbers, and suppressive signals from the tumor microenvironment (TME) of Prostate Cancer (PCa), can negatively impact NK cell efficacy. GTB-5550 was specifically designed as a novel tri-specific killer engager (TriKE) molecule with three components: an arm that engages with CD16, an activating receptor of NK cells, an arm that binds to tumor antigens expressed in prostate cancer (PSMA or B7H3), and an interleukin (IL)-15 moiety that is essential for NK cell survival, proliferation, priming and motility.

"These preclinical findings provide additional support for our TriKE technology and the specific mechanism of action for this construct in promoting NK-specific proliferation, effective killing of target cells and ability to bypass the myeloid-derived suppressor cells (MDSC)-induced suppression of NK cells," stated Dr. Jeffrey Miller*, MD, GT Biopharma’s Consulting Chief Medical Officer and Consulting Chief Scientific Officer. "All of this bodes well as we progress this specific TriKE towards the clinic with the goal of an eventual indication in prostate cancer."

Key findings demonstrated that normal donor and prostate cancer patient NK cells displayed better, specific, degranulation against prostate cancer cell lines in the presence of PSMA or B7H3 TriKEs. NK cell cytotoxicity was also improved, even in the presence of enzalutamide resistant lines, hypoxia, or MDSCs. The TriKE molecules displayed improved tumor control, compared to IL-15 control or no treatment, in xenogeneic models of prostate cancer.

Society For Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 2023 Annual Meeting – November 1-5, 2023

Poster Title: Maximizing NK Cell Immunotherapy in Prostate Cancer vis TriKEs
Abstract: 1180
Date: Saturday, November 4, 2023
Time: 2:55 pm -4:25 pm & 10:00 pm – 11:30 pm ET
Presenter: Martin Felices*, PhD, Associate Professor of Medicine, University of Minnesota
*Drs Jeff Miller (consultant CMO) and Martin Felices are consultants for GT Biopharma and hold equity.

On November 6, 2023 FibroGen, Inc. (NASDAQ: FGEN) reported financial results for the third quarter 2023 and provided an update on the Company’s recent developments (Press release, FibroGen, NOV 6, 2023, View Source [SID1234637024]).

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"Today, we reported another quarter of strong roxadustat volume growth in China, achieving the highest ever value share, at 42%, in the anemia of CKD category," said Thane Wettig, Chief Executive Officer, FibroGen. "The continued strength of our China business, sooner than expected realization of our corporate cost reduction efforts and our strong balance sheet provide us a cash runway into 2026. Over the next 12 months, we will obtain data read-outs from our two late-stage pancreatic cancer trials, start a Phase 2 metastatic castrate-resistant prostate cancer trial, and file two immuno-oncology INDs. 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."

Recent Developments and Key Events of Third Quarter 2023:

•
Appointed Thane Wettig as Chief Executive Officer.
•
Supplemental New Drug Application (sNDA) accepted by the China Health Authority for roxadustat for the treatment of patients with chemotherapy-induced anemia (CIA). Expect approval decision of CIA in China in mid-2024.
•
Successful implementation of cost reduction plan, now resulting in an expected reduction of total annualized expenses of $120 million.
•
Reported negative topline results from the LELANTOS-2 Phase 3 study of pamrevlumab for the treatment of ambulatory patients with Duchenne muscular dystrophy (DMD).
•
Presented Phase 3 data of roxadustat for CIA in patients with non-myeloid malignancies in an oral presentation at the European Society for Medical Oncology Congress 2023.
•
FibroGen and its partners presented five roxadustat abstracts, including four poster presentations and one late-breaker poster presentation, at the recent American Society of Nephrology (ASN) Kidney Week 2023 conference.
•
Presented preclinical data for the FG-3165 anti-Gal9 antibody program at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting 2023.

China Performance:

•
Achieved third quarter net product revenue under U.S. GAAP from the sale of roxadustat in China of $29.4 million compared to $17.4 million in the third quarter of 2022, an increase of 69% year over year.
•
Achieved third quarter total roxadustat net sales in China1 by FibroGen and the distribution entity (JDE) jointly owned by FibroGen and AstraZeneca of $77.1 million, compared to $59.0 million in the third quarter of 2022, an increase of 31% year over year, driven by 37% growth in volume.
•
Roxadustat continues to be the number one brand based on value share in the anemia of chronic kidney disease market in China. Total roxadustat net sales in China includes sales made by the distribution entity as well as FibroGen China’s direct sales, each to its own distributors. The distribution entity jointly owned by AstraZeneca and FibroGen is not consolidated into FibroGen’s financial statements.

Upcoming Milestones:

Pamrevlumab

•
Topline data from the LAPIS Phase 3 study of pamrevlumab in locally advanced unresectable pancreatic cancer (LAPC) expected in 1Q 2024.
•
Topline data from the PanCAN Precision PromiseSM Phase 2/3 study of pamrevlumab in metastatic pancreatic cancer expected in 1H 2024.
Oncology Pipeline

•
Expect topline clinical trial results from Phase 1 monotherapy trial of FG-3246, a first-in-class antibody-drug conjugate (ADC) targeting a novel epitope on CD46 for metastatic castration-resistant prostate cancer (mCRPC) by 1Q 2024.
•
Anticipate the initiation of a Phase 2 trial of FG-3246 for 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 2H 2024.

Financial:

•
Total revenue for the third quarter of 2023 was $40.1 million, as compared to $15.7 million for the third quarter of 2022, an increase of 155% year over year.
•
Net loss for the third quarter of 2023 was $63.6 million, or $0.65 net loss per basic and diluted share, compared to a net loss of $91.7 million, or $0.98 net loss per basic and diluted share one year ago.
•
Restructuring charge for the third quarter of 2023 was $12.6 million, or $0.13 impact to net loss per basic and diluted share, resulting from the reduction in U.S. workforce announced in July 2023.
•
At September 30, 2023, cash – defined as cash, cash equivalents, investments, and accounts receivable – was $283.0 million.
•
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, November 6, 2023, 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 in to 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. FibroGen and AstraZeneca are collaborating on the development and commercialization of roxadustat for the potential treatment of anemia in the U.S., China, and other markets not licensed to Astellas.