Phase 3 clinical trial evaluating F351 for the treatment of CHB-associated liver fibrosis in the PRC remains on track with data anticipated by early 2025
Acquired the rights to complementary assets relating to nintedanib through
Cash and cash equivalents totaled
“Supported by sales of our market-leading IPF drug, ETUARY, Gyre is well-positioned to advance multiple pipeline programs addressing organ fibrosis, including our Phase 3 clinical trial of F351 in CHB-associated liver fibrosis in the PRC that is on track to report data by early 2025,” said
First Quarter 2024 Business Highlights and Upcoming Milestones
ETUARY (Pirfenidone capsules) Sales Update
- Generated sales of
$26.9 million in Q1 of 2024. For the quarter endedMarch 31, 2024 ,Beijing Continent Pharmaceuticals Co., Ltd. (d/b/aGyre Pharmaceuticals ), Gyre’s majority indirectly owned subsidiary inthe People's Republic of China (“PRC”), generated$26.9 million in sales of ETUARY, representing an increase of 10% from the same period in 2023, driven by enhanced marketing and sales initiatives in regions of the PRC where sales were previously lower in the first quarter of fiscal year 2023.
Clinical Development Updates
F351 (Hydronidone):
- Phase 3 trial evaluating F351 for the treatment of Chronic Hepatitis B (“CHB”)-associated liver fibrosis remains on track with topline data expected by early 2025. In
October 2023 ,Gyre Pharmaceuticals completed enrollment of its Phase 3 trial in patients with CHB-associated liver fibrosis in the PRC. The trial is evaluating 248 patients with a primary endpoint of the reduction of the liver fibrosis score (Ishak Scoring System) by at least one grade after taking F351 in combination with entecavir.Gyre Pharmaceuticals expects to report topline data by early 2025. - Plans to initiate a Phase 2a clinical trial in Non-Alcoholic Steatohepatitis (“NASH”)-associated liver fibrosis in 2025. Gyre expects to file an investigational new drug (“IND”) application with the
U.S. Food and Drug Administration (“FDA”) by the end of 2024. Pending FDA review and the results from the PRC Phase 3 trial in CHB-associated liver fibrosis, Gyre intends to initiate a Phase 2a proof-of-concept clinical trial to evaluate F351 for the treatment of NASH-associated liver fibrosis in 2025.
F573:
- Ongoing Phase 2 trial in the PRC.
Gyre Pharmaceuticals is conducting a randomized, double-blind, placebo-controlled Phase 2 clinical trial in the PRC to assess the safety and efficacy of F573, a caspase inhibitor for the treatment of acute/acute on-chronic liver failure (“ALF/ACLF”).
Preclinical Development Updates
- F230: F230 is a selective endothelin receptor agonist.
Gyre Pharmaceuticals is evaluating F230 in the PRC for the treatment of pulmonary arterial hypertension (“PAH”) in preclinical studies. InMarch 2024 ,Gyre Pharmaceuticals submitted an IND application for F230 in the PRC. - F528: F528 is a novel anti-inflammation agent that targets the inhibition of multiple inflammatory cytokines and has the potential to modify the progression of chronic obstructive pulmonary disease (“COPD”) with low toxicity in vivo.
Gyre Pharmaceuticals is evaluating F528 in preclinical studies as a potential first-line therapy for the treatment of COPD in the PRC.
Corporate Updates
- In
May 2024 ,Gyre Pharmaceuticals executed a comprehensive agreement withJiangsu Wangao Pharmaceuticals Co., Ltd. to acquire the rights to complementary assets and know-how relating to nintedanib, a kinase inhibitor for the treatment of idiopathic pulmonary fibrosis. The agreement is intended to enableGyre Pharmaceuticals to provide patients more choices and benefits, improve patient access to nintedanib through its PRC nationwide sales network, and further enhance Gyre Pharmaceuticals’ competitiveness with respect to treatments for pulmonary fibrosis.
Financial Results
Cash Position
As of
Financial Results for the Quarter Ended
- Revenues: For the three months ended
March 31, 2024 , revenues were$27.2 million as a result of Gyre’s indirect controlling interest inGyre Pharmaceuticals . For the three months endedMarch 31, 2023 , revenues were$24.9 million . The increase was driven by a$2.2 million increase in sales of pharmaceuticals products as a result of enhanced marketing and sales initiatives in regions of the PRC where sales were previously lower in the first quarter of 2023. - Cost of Revenues: For the three months ended
March 31, 2024 , cost of revenues was$1.0 million as a result of Gyre’s indirect controlling interest inGyre Pharmaceuticals . For the three months endedMarch 31, 2023 , cost of revenues was$1.1 million . The decrease was primarily driven by a$0.1 million decrease in raw materials mainly due to the stoppage loss that occurred at the Cangzhou factory in 2023. - Selling & Marketing Expense: For the three months ended
March 31, 2024 , selling and marketing expense was$12.5 million , compared to$12.8 million for the same period in 2023. The decrease was primarily driven by a$1.8 million decrease in conference costs due to a decrease in conference activity, offset by a$1.5 million increase in staff costs due to an increase in staff headcount. - R&D Expense: For the three months ended
March 31, 2024 , research and development expense was$2.2 million , compared to$2.6 million for the same period in 2023. The decrease was primarily attributable to a$0.5 million decrease in clinical trial expenses and a$0.1 million decrease in pre-clinical research expenses. The latter is a result of several research and development projects advancing to the clinical trials stage or reaching the application phase in 2023. This overall decrease was partially offset by a$0.2 million increase in research and development payroll costs due to increased headcount. - G&A Expense: For the three months ended
March 31, 2024 , general and administrative expense was$3.4 million , compared to$1.7 million for the same period in 2023. The increase was primarily attributable to a$1.2 million increase in payroll expenses and a$0.6 million increase in miscellaneous expenses mainly related to IT and computer as well as office consumables expenses. - Income from Operations: For the three months ended
March 31, 2024 , income from operations was$8.1 million , compared to$6.7 million in income from operations for the same period in 2023. - Net Income: For the three months ended
March 31, 2024 , net income was$9.9 million , compared to$4.2 million in net income for the same period in 2023. - Net Income Attributable to Common Stockholders: For the three months ended
March 31, 2024 , net income attributable to common stockholders was$7.5 million , compared to$2.2 million in net income attributable to common stockholders for the same period in 2023.
Use of Non-GAAP Financial Measures by
Gyre reports financial results in accordance with accounting principles generally accepted in
About Hydronidone (F351)
F351 is a structural analogue of the approved anti-fibrotic (IPF) drug Pirfenidone and has been shown to inhibit in vitro both p38γ kinase activity and TGF-β1-induced excessive collagen synthesis in hepatic stellate cells (“HSCs”), which are recognized as critical event in the development and progression of fibrosis in the liver. This is further supported by its anti-proliferative effects on the HSCs in the liver. In vitro anti-fibrotic effects of F351 were also confirmed in several established in vivo models of liver fibrosis such as CCI4-induced liver fibrosis mouse model, DMN-induced liver fibrosis rat model, and HSA-induced liver rat model, as well as mouse model of NASH fibrosis (CCI4+Western High Fat Diet).
About
About Gyre Therapeutics
Gyre Therapeutics is a biopharmaceutical company headquartered in
Forward-Looking Statements
This press release contains “forward-looking statements” within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995, which statements are subject to substantial risks and uncertainties and are based on estimates and assumptions. All statements, other than statements of historical facts included in this press release, are forward-looking statements, including statements concerning: the expectations regarding Gyre’s research and development efforts, timing of expected clinical readouts, including timing of topline data from Gyre Pharmaceuticals’ Phase 3 clinical trial evaluating F351 for the treatment of CHB-associated liver fibrosis in the PRC, the
Gyre expressly disclaims any obligation to update any forward-looking statements whether as a result of new information, future events or otherwise, except as required by law.
For Investors:
stephen@gilmartinir.com
Condensed Consolidated Statements of Operations (Unaudited) (In thousands, except share and per share amounts) | |||||||
Three Months Ended | |||||||
2024 | 2023 | ||||||
Revenues | $ | 27,172 | $ | 24,931 | |||
Operating expenses: | |||||||
Cost of revenues | 979 | 1,125 | |||||
Selling and marketing | 12,542 | 12,768 | |||||
Research and development | 2,182 | 2,635 | |||||
General and administrative | 3,398 | 1,739 | |||||
Total operating expenses | 19,101 | 18,267 | |||||
Income from operations | 8,071 | 6,664 | |||||
Other income (expense), net: | |||||||
Interest income, net | 328 | 184 | |||||
Other income | 109 | 66 | |||||
Change in fair value of warrant liability | 4,288 | — | |||||
Other expenses | (315 | ) | (643 | ) | |||
Income before income taxes | 12,481 | 6,271 | |||||
Provision for income taxes | (2,546 | ) | (2,054 | ) | |||
Net income | 9,935 | 4,217 | |||||
Net income attributable to noncontrolling interest | 2,403 | 1,973 | |||||
Net income attributable to common stockholders | $ | 7,532 | $ | 2,244 | |||
Net income per share attributable to common stockholders: | |||||||
Basic | $ | 0.09 | $ | 0.04 | |||
Diluted | $ | 0.03 | $ | 0.03 | |||
Weighted average shares used in calculating net income per share attributable to common stockholders: | |||||||
Basic | 83,265,879 | 63,588,119 | |||||
Diluted | 102,594,197 | 78,921,366 | |||||
Condensed Consolidated Balance Sheets (Unaudited) (In thousands, except share and per share amounts) | |||||||
(Unaudited) | |||||||
Assets | |||||||
Current assets: | |||||||
Cash and cash equivalents | $ | 29,785 | $ | 33,509 | |||
Short-term bank deposits | 7,567 | $ | — | ||||
Accounts and note receivables, net | 15,458 | 15,552 | |||||
Other receivables from GNI | 1,287 | 1,287 | |||||
Inventories, net | 4,939 | 4,281 | |||||
Prepaid assets | 1,790 | 1,547 | |||||
Other current assets | 1,897 | 1,045 | |||||
Total current assets | 62,723 | 57,221 | |||||
Property and equipment, net | 23,564 | 23,288 | |||||
Long-term receivable from GCBP | 4,780 | 4,722 | |||||
Intangible assets, net | 196 | 205 | |||||
Right-of-use assets | 359 | 489 | |||||
Land use rights, net | 1,480 | 1,493 | |||||
Deferred tax assets | 5,000 | 4,695 | |||||
Long-term certificates of deposit | 23,106 | 23,431 | |||||
Other assets, noncurrent | 802 | 995 | |||||
Total assets | $ | 122,010 | $ | 116,539 | |||
Liabilities, convertible preferred stock, and equity | |||||||
Current liabilities: | |||||||
Accounts payable | $ | 330 | $ | 355 | |||
Deferred revenue | 35 | 39 | |||||
Due to related parties | 1,362 | 1,369 | |||||
CVR excess closing cash payable | 422 | 1,085 | |||||
Accrued expenses and other current liabilities | 10,767 | 11,935 | |||||
Income tax payable | 6,470 | 5,054 | |||||
Operating lease liabilities, current | 100 | 210 | |||||
Total current liabilities | 19,486 | 20,047 | |||||
Operating lease liabilities, noncurrent | 175 | 199 | |||||
Deferred government grants | 203 | 213 | |||||
CVR derivative liability, noncurrent | 4,780 | 4,722 | |||||
Warrant liability, noncurrent | 8,547 | 12,835 | |||||
Other noncurrent liabilities | 48 | 49 | |||||
Total liabilities | 33,239 | 38,065 | |||||
Convertible Preferred Stock, | — | 64,525 | |||||
Stockholders’ equity: | |||||||
Common stock, | 85 | 77 | |||||
Additional paid-in capital | 133,199 | 68,179 | |||||
Statutory reserve | 3,098 | 3,098 | |||||
Accumulated deficit | (78,006 | ) | (85,538 | ) | |||
Accumulated other comprehensive loss | (1,736 | ) | (1,644 | ) | |||
Total Gyre stockholders’ equity (deficit) | 56,640 | (15,828 | ) | ||||
Noncontrolling interest | 32,131 | 29,777 | |||||
Total equity | 88,771 | 13,949 | |||||
Total liabilities, convertible preferred stock, and equity | $ | 122,010 | $ | 116,539 | |||
Reconciliation of GAAP to Non-GAAP Financial Measures (Unaudited) (In thousands) | ||||||
Three Months Ended | ||||||
2024 | 2023 | |||||
Net income | $ | 9,935 | $ | 4,217 | ||
Gain from change in fair value of warrants (1) | (4,288 | ) | — | |||
Stock-based compensation | 11 | — | ||||
Provision for income taxes | 2,546 | 2,054 | ||||
Non-GAAP adjusted net income | $ | 8,204 | $ | 6,271 |
(1) Reflects adjustments for fair value of warrants based on the Black-Scholes option pricing model.
Source:
2024 GlobeNewswire, Inc., source