SAN FRANCISCO, March 17, 2025 (GLOBE NEWSWIRE) -- FibroGen, Inc. (NASDAQ: FGEN) today reported financial results for the fourth quarter and full year 2024 and provided an update on the company’s recent developments.
“We entered 2025 optimistic about our future, highlighted by the planned initiation of the Phase 2 monotherapy trial of FG-3246, our first-in-class ADC targeting CD46 for the treatment of mCRPC, by mid-2025,” said Thane Wettig, Chief Executive Officer. “Through the successful implementation of our cost reduction plan, and upon the closing of our recently announced sale of FibroGen China, we will be a leaner and more focused organization, with a stronger financial position and a cash runway that takes us into 2027, with multiple potential value-creating milestones in sight.”
Recent Developments and Key Highlights of 2024:
Upcoming Milestones:
FG-3246 (CD46 Targeting ADC) and FG-3180 (CD46 Targeting PET Imaging Agent)
Roxadustat
Financial:
Conference Call and Webcast Presentation
The FibroGen management team will host a conference call and webcast presentation to discuss the financial results and provide a business update. A live Q&A session will follow the brief presentation. Interested parties may access a live audio webcast of the conference call here. To access the call by phone, please register here, and you will be provided with dial in details. A replay of the webcast will also be available for a limited time on the Events & Presentations page on FibroGen’s website.
About FG-3246
FG-3246 (FOR46) is a potential first-in-class fully human antibody-drug conjugate (ADC), exclusively in-licensed from Fortis Therapeutics, and is being developed by FibroGen for metastatic castration-resistant prostate cancer and potentially other tumor types. FG-3246 binds to an epitope of CD46, a cell receptor target, that induces internalization upon antibody binding, is present at high levels in prostate cancer and other tumor types and demonstrates very limited expression in most normal tissues. FG-3246 is comprised of an anti-CD46 antibody, YS5, linked to the anti-mitotic agent, MMAE, which is a clinically and commercially validated ADC payload. FG-3246 has demonstrated anti-tumor activity in both preclinical and clinical studies.
FG-3246 is currently in an ongoing Phase 1b/2 study being conducted at UCSF as an investigator-sponsored trial to evaluate FG-3246 in combination with enzalutamide. An additional investigator-sponsored radiopharmaceutical marker trial using a zirconium-89 positron emission tomography (PET) tracer for CD46 that utilizes the YS5 antibody is also underway at UCSF. The initiation of the Phase 2 monotherapy dose optimization trial for FG-3246 in metastatic castration-resistant prostate cancer is anticipated by mid-2025. FG-3246 is an investigational drug and not approved for marketing by any regulatory authority.
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). FibroGen has the sole rights to roxadustat in the United States, Canada, Mexico, and in all markets not held by AstraZeneca or licensed to Astellas. Astellas and FibroGen are collaborating on the commercialization of roxadustat for the treatment of anemia in territories including Japan, Europe, Turkey, Russia, and the Commonwealth of Independent States, the Middle East, and South Africa.
About FibroGen
FibroGen, Inc. is a biopharmaceutical company focused on development of novel therapies at the frontiers of cancer biology and anemia. Roxadustat (爱瑞卓®, EVRENZO™) is currently approved in China, Europe, Japan, and numerous other countries for the treatment of anemia in chronic kidney disease (CKD) patients on dialysis and not on dialysis. The Company continues to evaluate a development plan for roxadustat in anemia associated with lower-risk myelodysplastic syndrome (LR-MDS) in the U.S. FG-3246 (also known as FOR46), a first-in-class antibody-drug conjugate (ADC) targeting CD46 is in development for the treatment of metastatic castration-resistant prostate cancer. This program also includes the development of FG-3180, an associated CD46-targeted PET biomarker. For more information, please visit www.fibrogen.com.
Forward-Looking Statements
This release contains forward-looking statements regarding FibroGen’s strategy, future plans and prospects, including statements regarding its commercial products and clinical programs and those of its collaboration partners Fortis and UCSF. These forward-looking statements include, but are not limited to, statements regarding the efficacy, safety, and potential clinical or commercial success of FibroGen products and product candidates, statements under the caption “Upcoming Milestones”, the net cash portion of the purchase price and closing of the sale of FibroGen China as well as the payoff of the Morgan Stanley Tactical Value term loan, statements regarding cash, such as the expectation that cash, cash equivalents and accounts receivable will be sufficient to fund FibroGen’s operating plans into 2027, and statements about FibroGen’s plans and objectives. These forward-looking statements are typically identified by use of terms such as “may,” “will”, “should,” “on track,” “could,” “expect,” “plan,” “anticipate,” “believe,” “estimate,” “predict,” “potential,” “continue” and similar words, although some forward-looking statements are expressed differently. FibroGen’s actual results may differ materially from those indicated in these forward-looking statements due to risks and uncertainties related to the continued progress and timing of its various programs, including the enrollment and results from ongoing and potential future clinical trials, and other matters that are described in FibroGen’s most recent Annual Report on Form 10-K and Quarterly Report on Form 10-Q, each as filed with the Securities and Exchange Commission (SEC), including the risk factors set forth therein. Investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release, and FibroGen undertakes no obligation to update any forward-looking statement in this press release, except as required by law.
Condensed Consolidated Balance Sheets
(In thousands)
| December 31, 2024 | December 31, 2023 | |||||||
| (Unaudited) | ||||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 50,482 | $ | 81,553 | ||||
| Short-term investments | — | 121,898 | ||||||
| Accounts receivable, net | 481 | 5,121 | ||||||
| Inventory | 3,155 | 17,173 | ||||||
| Prepaid expenses and other current assets | 31,542 | 40,038 | ||||||
| Current assets held for sale | 110,849 | 65,776 | ||||||
| Total current assets | 196,509 | 331,559 | ||||||
| Restricted time deposits | — | 1,658 | ||||||
| Property and equipment, net | — | 4,785 | ||||||
| Operating lease right-of-use assets | — | 64,939 | ||||||
| Other assets | 1,405 | 2,538 | ||||||
| Long-term assets held for sale | 16,611 | 18,050 | ||||||
| Total assets | $ | 214,525 | $ | 423,529 | ||||
| Liabilities, stockholders’ equity and non-controlling interests | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 5,064 | $ | 15,778 | ||||
| Accrued and other liabilities | 62,035 | 132,987 | ||||||
| Deferred revenue | 27,290 | 12,740 | ||||||
| Operating lease liabilities, current | — | 12,647 | ||||||
| Current liabilities held for sale | 38,917 | 43,516 | ||||||
| Total current liabilities | 133,306 | 217,668 | ||||||
| Product development obligations | 17,012 | 17,763 | ||||||
| Deferred revenue, net of current | 114,708 | 157,555 | ||||||
| Operating lease liabilities, non-current | — | 65,033 | ||||||
| Senior secured term loan facilities, non-current | 73,092 | 71,934 | ||||||
| Liability related to sale of future revenues, non-current | 58,864 | 51,413 | ||||||
| Other long-term liabilities | 822 | 2,858 | ||||||
| Long-term liabilities held for sale | 356 | 1,504 | ||||||
| Total liabilities | 398,160 | 585,728 | ||||||
| Redeemable non-controlling interests | 21,480 | 21,480 | ||||||
| Total stockholders’ deficit attributable to FibroGen | (225,602 | ) | (204,166 | ) | ||||
| Nonredeemable non-controlling interests | 20,487 | 20,487 | ||||||
| Total deficit | (205,115 | ) | (183,679 | ) | ||||
| Total liabilities, redeemable non-controlling interests and deficit | $ | 214,525 | $ | 423,529 |
Condensed Consolidated Statements of Operations
(In thousands, except per share data)
| Three Months Ended December 31, | Years Ended December 31, | |||||||||||||||
| 2024 | 2023 | 2024 | 2023 | |||||||||||||
| (Unaudited) | ||||||||||||||||
| Revenue: | ||||||||||||||||
| License revenue | $ | — | $ | — | $ | — | $ | 9,649 | ||||||||
| Development and other revenue | 416 | 2,575 | 1,948 | 18,401 | ||||||||||||
| Drug product revenue, net | 2,720 | 1,052 | 27,673 | 18,753 | ||||||||||||
| Total revenue | 3,136 | 3,627 | 29,621 | 46,803 | ||||||||||||
| Operating costs and expenses: | ||||||||||||||||
| Cost of goods sold | (5,845 | ) | 1,201 | 15,561 | 3,962 | |||||||||||
| Research and development | 6,870 | 48,710 | 95,692 | 266,473 | ||||||||||||
| Selling, general and administrative | 8,345 | 16,378 | 49,330 | 86,483 | ||||||||||||
| Restructuring charge | 900 | — | 19,454 | 12,606 | ||||||||||||
| Total operating costs and expenses | 10,270 | 66,289 | 180,037 | 369,524 | ||||||||||||
| Loss from operations | (7,134 | ) | (62,662 | ) | (150,416 | ) | (322,721 | ) | ||||||||
| Interest and other, net: | ||||||||||||||||
| Interest expense | (2,217 | ) | (2,175 | ) | (8,247 | ) | (8,095 | ) | ||||||||
| Interest income and other income (expenses), net | 688 | 2,314 | 5,296 | 7,594 | ||||||||||||
| Total interest and other, net | (1,529 | ) | 139 | (2,951 | ) | (501 | ) | |||||||||
| Loss from continuing operations before income taxes | (8,663 | ) | (62,523 | ) | (153,367 | ) | (323,222 | ) | ||||||||
| Benefit from income taxes | 2 | 10 | (269 | ) | (252 | ) | ||||||||||
| Loss from continuing operations | (8,665 | ) | (62,533 | ) | (153,098 | ) | (322,970 | ) | ||||||||
| Income from discontinued operations, net of tax | 26,647 | 6,301 | 105,519 | 38,738 | ||||||||||||
| Net income (loss) | $ | 17,982 | $ | (56,232 | ) | $ | (47,579 | ) | $ | (284,232 | ) | |||||
| Loss from continuing operations per share – basic and diluted | $ | (0.08 | ) | $ | (0.63 | ) | $ | (1.53 | ) | $ | (3.32 | ) | ||||
| Income from discontinued operations per share – basic and diluted | 0.26 | 0.06 | 1.05 | 0.40 | ||||||||||||
| Net income (loss) per share – basic and diluted | $ | 0.18 | $ | (0.57 | ) | $ | (0.48 | ) | $ | (2.92 | ) | |||||
| Weighted average number of common shares used to calculate net income (loss) per share – basic and diluted | 100,830 | 98,496 | 100,044 | 97,303 |
For Investor Inquiries:
David DeLucia, CFA
Senior Vice President and Chief Financial Officer
ir@fibrogen.com