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8-K

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

 

FORM 8-K

 

 

CURRENT REPORT

Pursuant to Section 13 or 15(d)

of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): January 7, 2019

 

 

FibroGen, Inc.

(Exact name of registrant as specified in its charter)

 

 

 

Delaware   001-36740   77-0357827

(State or other jurisdiction

of incorporation)

  

(Commission

File Number)

  

(IRS Employer

Identification No.)

FibroGen, Inc.

409 Illinois Street

San Francisco, CA 94158

(Address of principal executive offices, including zip code)

(415) 978-1200

(Registrant’s telephone number, including area code)

Not Applicable

(Former name or former address, if changed since last report.)

 

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

 

☐

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

☐

Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

☐

Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

☐

Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Indicate by check mark whether the registrant is an emerging growth company as defined in as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging growth company  ☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.  ☐

 

 

 

Item 7.01 Regulation FD Disclosure

Beginning January 7, 2019, FibroGen, Inc. (the Company) intends to conduct meetings with existing and prospective investors and analysts in which its corporate slide presentation will be presented. A copy of the presentation materials, including a slide setting forth certain cautionary statements intended to qualify the forward-looking statements therein, is attached as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.

The information in this Item 7.01 is being furnished, not filed, pursuant to Regulation FD. Accordingly, the information in Item 7.01 of this report will not be incorporated by reference into any registration statement filed by the Company under the Securities Act of 1933, as amended, unless specifically identified therein as being incorporated therein by reference. The furnishing of the information in this report is not intended to, and does not, constitute a determination or admission by the Company that the information in this report is material or complete, or that investors should consider this information before making an investment decision with respect to any security of the Company.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits

 

Exhibit
No.		   

Description

99.1    FibroGen, Inc. Presentation Materials dated January 7, 2019.

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

    FIBROGEN, INC.
Dated: January 7, 2019     By:           /s/ Michael Lowenstein
              Michael Lowenstein
              Chief Legal Officer
EX-99.1

Slide 1

FibroGen, Inc. Corporate Presentation January 2019 Exhibit 99.1

Slide 2

This presentation contains “forward-looking” statements that involve substantial risks and uncertainties. All statements other than statements of historical facts contained in this presentation, including statements regarding our future financial condition, business strategy, and plans, and objectives of management for future operations, are forward looking statements. These forward-looking statements can generally be identified by terminology such as “believe,” “will,” “may,” “estimate,” “continue,” “anticipate,” “contemplate,” “intend,” “target,” “project,” “should,” “plan,” “expect,” “predict,” “could,” “or potentially,” or by the negative of these terms or other similar expressions. Forward-looking statements appear in a number of places throughout this presentation and include statements regarding our intentions, beliefs, projections, outlook, analyses, or current expectations concerning, among other things, our ongoing and planned development and clinical trials, the timing of and our ability to make regulatory filings and obtain and maintain regulatory approvals for roxadustat, pamrevlumab, and our other product candidates, the potential safety, efficacy, reimbursement, convenience, or clinical and pharmaco-economic benefits of our product candidates, including in China, the potential markets for any of our product candidates, our ability to develop commercial functions, or our ability to operate in China, expectations regarding clinical trial data, our results of operations, cash needs, spending of proceeds from our public offerings, financial condition, liquidity, prospects, growth, and strategies, the industry in which we operate, and the trends that may affect the industry or us. Forward-looking statements involve known and unknown risks, uncertainties, assumptions, and other factors that may cause our actual results, performance, or achievements to be materially different from any future results, performance, or achievements expressed or implied by the forward-looking statements. Forward-looking statements represent our management’s beliefs and assumptions only as of the date of this presentation. Except as required by law, we assume no obligation to update these forward-looking statements publicly, or to update the reasons why actual results could differ materially from those anticipated in the forward-looking statements, even if new information becomes available in the future. Forward-Looking Statements

Slide 3

2019: A Transformational Year >5 Anemia associated with CKD Approved in China for dialysis in 2018 NDA approval decisions expected in 2019: Japan for dialysis China for non-dialysis NDA submissions expected in 2019: U.S., EU, other territories Anemia Associated with MDS One U.S./EU Phase 3, one China Phase 2/3 trial ongoing ROXADUSTAT TWO FIRST-IN-CLASS PRODUCT PLATFORMS ADDRESSING MAJOR MARKETS WITH SIGNIFICANT PATIENT NEED 1 PAMREVLUMAB IPF Phase 3 study starting in 2019 Pancreatic Cancer Phase 3 study starting in 2019 DMD Phase 2 trial ongoing 1 2

Slide 4

Product Portfolio HIF-PHI PRECLINICAL PHASE 1 PHASE 2 PHASE 3 APPROVED Roxadustat CKD Anemia United States, Europe China1 Japan2 Roxadustat MDS Anemia United States, Europe China (Phase 2/3) ANTI-CTGF PRECLINICAL PHASE 1 PHASE 2 PHASE 3 Pamrevlumab Idiopathic Pulmonary Fibrosis Pancreatic Cancer Duchenne Muscular Dystrophy Wholly Owned Partnered 1Dialysis-dependent NDA approved; non-dialysis dependent NDA filed in China 2Dialysis-dependent NDA filed in Japan; non-dialysis dependent trials are ongoing

Slide 5

Corporate and Financial 465 employees worldwide 310 U.S. 155 ex-U.S. San Francisco headquarters with subsidiary in Beijing Appointed Maykin Ho, Ph.D., to Board of Directors in December 2018 Well-managed financial position No debt Year-end cash balance projection of $720M to $730M $722M cash as of September 30, 2018; no debt

Slide 6

Roxadustat Anemia

Slide 7

Roxadustat: An Innovative Approach to Addressing Anemia *First approved in China for anemia associated with CKD in dialysis-dependent patients on December 17, 2018. ROXADUSTAT HAS BEEN SHOWN TO BE MORE THAN AN ORAL ALTERNATIVE TO ESAs Overcomes suppressive effects of inflammation on erythropoiesis Coordinate iron mobilization, hepcidin reduction Erythropoietin levels within or near physiological range Superiority to ESAs has been shown in hemoglobin change from baseline and reduction in risk of blood cell transfusion + >> INTERNALLY ADVANCED BY FIBROGEN FROM DISCOVERY THROUGH LATE-STAGE CLINICAL DEVELOPMENT AND APPROVAL* Dialysis-dependent and non-dialysis-dependent CKD patients Anemia associated with MDS PARTNERED WITH ASTRAZENECA AND ASTELLAS Astellas: Europe, Middle East, CIS, South Africa, Japan AstraZeneca: U.S./ROW; China

Slide 8

Roxadustat: The Leader in Oral HIF-PHI Anemia Therapeutics Anemia in CKD Patients U.S./EU Positive Phase 3 results from five trials announced by FibroGen and AstraZeneca December 2018 Positive Phase 3 topline results announced by Astellas from first EU study All Phase 3 studies supporting U.S. NDA and EU MAA completed MACE pooled analysis readouts (DD, NDD) anticipated in 1H 2019 U.S. NDA submission planned for 1H 2019 China NDA approved by the NMPA for dialysis-dependent patients in December 2018 NDA approval anticipated for non-dialysis in 1H 2019 Launch planned for 2H 2019 Japan NDA for dialysis-dependent patients submitted to PMDA in September, 2018 Astellas completed 1 of 2 CKD non-dialysis dependent Phase 3 studies needed for sNDA Anemia Associated with MDS U.S. Phase 3 and China Phase 2/3 studies underway

Slide 9

Roxadustat in China FIRST APPROVAL China is the first country to approve a HIF-PHI FIRST TO MARKET Commercialization Activities FibroGen and AstraZeneca China working closely to prepare for 2H 2019 launch FibroGen China to lead: Medical Affairs Pharmacovigilance Regulatory Affairs Commercial Manufacturing Post-Approval Clinical Development AstraZeneca China to lead: Marketing Market Access Sales Commercial Operations

Slide 10

U.S. and China CKD Anemia Market Opportunity ADDRESSING UNDERSERVED, GROWING, AND EMERGENT PATIENT POPULATIONS 1United States Renal Data System (USRDS) estimate as of 2016 UNITED STATES CHINA >35M CKD patients Linked to diabetes and hypertension Hepcidin modulation may benefit broader CKD anemia population > 500K Dialysis patients1 AZ leads marketing, sales, and distribution with strong presence in diabetes and hypertension markets >500K CKD dialysis patients Double-digit Y/Y growth rate Large DD population significantly undertreated “Severe disease” reimbursement classification AZ leads marketing and sales with strong and established presence

Slide 11

CL-314 ESA naive, non-dialysis, open label 100 CL-310 ESA conversion, non-dialysis, vs. darbepoetin ~325 Japan Non-Dialysis Total N ~425 Global Registration Programs: Enrollment Summary GLOBAL PHASE 3 STUDIES FOR U.S. NDA, EU MAA DD-CKD Studies N Population, Comparator HIMALAYAS (FibroGen) 063 1,043 Incident dialysis, vs. epoetin α SIERRAS (FibroGen) 064 741 Stable/Incident dalysis, vs. epoetin α ROCKIES (AstraZeneca) 002 2,133 Stable/Incident dialysis, vs. epoetin α PYRENEES (Astellas) CL-613 838 Stable dialysis, vs. epoetin α or darbepoetin Dialysis Total N 4,755 NDD-CKD studies N Population, Comparator ANDES (FibroGen) 060 922 Non-dialysis, vs. placebo OLYMPUS (AstraZeneca) 001 2,782 Non-dialysis, vs. placebo ALPS (Astellas) CL-608 597 Non-dialysis, vs. placebo Non-Dialysis Total 4,301 DOLOMITES (Astellas) CL-610 616 Non-dialysis, vs. darbepoetin, for EU reimbursement JPN Studies Population, Comparator N CL-307 ESA conversion, hemodialysis, vs. darbepoetin 303 CL-312 ESA conversion long-term, hemodialysis, open label 164 CL-308 ESA naïve, hemodialysis, open label 75 CL-302 Peritoneal dialysis, open label 56 Japan Dialysis Total N 598 Completed China Phase 3 Studies Support China NDA Approval Completed Japan Phase 3 Dialysis Studies, NDA (DD) Submitted Sept’18 China Studies Population, Comparator N 806 Dialysis, vs. epoetin α 304 808 Non-dialysis, vs. placebo 151 China Phase 3 Total N 455 Japan Phase 3 CKD-NDD Studies for sNDA (NDD) Studies Completed

Slide 12

ANDES Roxadustat Phase 3 CKD-NDD Study(060) Randomized, double-blind, placebo-controlled study in U.S., APAC, S. America Chronic kidney disease (Stages 3, 4, or 5) not on dialysis, no prior ESA use N=922; roxadustat (n=616) vs. placebo (n=306) Treatment Duration: up to 4.5 years, mean=1.7 years U.S. Primary Endpoint Mean Hb change from baseline to the average over wks 28-52 (g/dL) EU Primary Efficacy Endpoint (U.S. Secondary Endpoint) % Hb Responders: 86.0% (roxadustat) vs. 6.6% (placebo), p=0.0007 Secondary Endpoints Time to first use of a rescue therapy (blood transfusion, ESA, or IV iron) in the first 52 weeks: 81% reduction in risk of rescue use (HR=0.19), p<0.0001 Time to first blood transfusion during the first 52 weeks: 74% reduction in blood transfusion risk (HR=0.26), p<0.0001 Safety: An overall safety profile consistent with the results observed in prior roxadustat studies. The adverse events reported are consistent with those expected in these study populations with similar background diseases g/dL P=0.0001 Mean (±SE) Hemoglobin (g/dL) (FAS)

Slide 13

HIMALAYAS Roxadustat Phase 3 Incident Dialysis Study (063) Randomized, open-label, active-controlled global study (U.S., Asia Pacific, Europe, Russia, S. America) Anemic incident dialysis patients with baseline Hb <10 g/dL, minimal to no prior ESA use N=1043; roxadustat (n=522) vs. epoetin alfa (n=521) Treatment Duration: up to 4.4 years, mean=1.8 years U.S. Primary Endpoint Mean Hb change from baseline to the average over Weeks 28-52 Non-inferior: LS-means (LSM) difference=0.18; lower bound of the 95% CI of (0.08, 0.29) ≥ 0.75 g/dL (NI margin); Superiority to epoetin alfa, p=0.0005 EU Primary Efficacy Endpoint (U.S. secondary endpoint) % Hb Responder: 88.2% (roxadustat) vs. 84.5% (epoetin alfa) Non-inferior: lower bound of the 95% CI (-0.9%, 7.6%) of the treatment difference is >-15% (NI margin)  Safety: An overall safety profile consistent with the results observed in prior roxadustat studies. The adverse events reported are consistent with those expected in these study populations with similar background diseases Mean (±SE) Hemoglobin (g/dL) (FAS)

Slide 14

SIERRAS Roxadustat Phase 3 Conversion Study in Dialysis Patients (064) Randomized, open-label, active-controlled U.S. study N=741; roxadustat (n=370) vs. epoetin alfa (n=371) Stable dialysis patients with baseline Hb 9 - 12 g/dL, on stable doses of ESA Newly initiated dialysis patients with baseline Hb 8.5 - 12 g/dL Treatment Duration: up to 3.5 years, mean=1.9 years U.S. Primary Endpoint Mean Hb change from baseline to the average over Weeks 28-52 Non-inferior to epoetin alfa: LSM difference = 0.48 g/dL Lower bound of the 95% CI of (0.37, 0.59) ≥0.75 g/dL (NI margin) Superiority over epoetin alfa, p<0.0001 EU Primary Efficacy Endpoint (U.S. Secondary Endpoint) Mean Hb change from baseline to the average over Wks 28-36 Non-inferior LSM difference = 0.53 g/dL Lower bound of the 95% CI of (0.39, 0.67) ≥0.75 g/dL (NI margin) Superiority over epoetin alfa, p<0.0001   Secondary Endpoint Time to first blood transfusion during the first 52 weeks: 33% reduction in blood transfusion risk (HR=0.67), p=0.0337 p<0.0001 Hb Change (g/dL) Safety: An overall safety profile consistent with the results observed in prior roxadustat studies. The adverse events reported are consistent with those expected in these study populations with similar background diseases Mean (±SE) Hemoglobin (g/dL) (FAS)

Slide 15

Olympus Phase 3 CKD-NDD Study Double-blind, placebo-controlled study in 26 countries CKD patients, non-dialysis (Stages 3, 4 or 5) with baseline Hb <10 g/dL N=2,781; randomized 1:1, roxadustat or placebo Primary Efficacy Endpoint The trial met its primary efficacy endpoint by demonstrating a statistically significant and clinically meaningful improvement in mean change from baseline in Hb levels averaged over Weeks 28 to 52 vs. placebo Rockies Phase 3 CKD-DD Study Open-label, active-controlled study in 18 countries ESRD patients, dialysis-dependent N=2,133; randomized 1:1, roxadustat or epoetin alfa Primary Efficacy Endpoint The trial met its primary efficacy endpoint by demonstrating a statistically significant improvement in mean change from baseline in Hb levels averaged over Weeks 28 to 52 vs. epoetin alfa Roxadustat Phase 3 Clinical Studies Topline Result (AstraZeneca Sponsored)

Slide 16

U.S. / EU Phase 3 MDS Study Patient population: transfusion-dependent, ESA-naïve, lower risk MDS patients Open-label lead-in: N up to 24 Starting doses (8 each): 1.5 mg/kg, 2.0 mg/kg, 2.5 mg/kg Double-blind, placebo-controlled: N=160 3:2 randomization, roxadustat vs. placebo Primary endpoint at 28 weeks: Cumulative % patients achieved transfusion independence (over at least 8 weeks) Safety exposure: up to 52 weeks Sites in U.S., EU, APAC Roxadustat Ongoing Pivotal MDS Anemia Studies China Phase 2/3 MDS Study Patient population: non-transfusion dependent with baseline Hb of 6 to 10 g/dL, lower risk MDS patients Open-label: N up to 40 Double-blind, placebo-controlled: N=135 2:1 randomization, roxadustat vs. placebo Primary endpoints at 26 weeks: % patients with Hb increased by 1.5 g/dL from baseline Treatment duration: 26 weeks ~30 sites in China

Slide 17

Pamrevlumab

Slide 18

Idiopathic Pulmonary Fibrosis (IPF) FDA Fast Track designation Phase 3 study planned to start in Q1 2019 Randomized placebo-controlled, double-blind study similar to PRAISE Phase 2b study design Primary endpoint will be change in forced vital capacity (FVC) from baseline Pancreatic Cancer (LAPC) FDA Fast Track and Orphan Drug Designation Phase 3 study planned to start in Q1 2019 Randomized double-blind, placebo-controlled study evaluating pamrevlumab in combination with gemcitabine and nab-paclitaxel as neoadjuvant treatment Assess resectability and resection rates with the primary endpoint of overall survival Duchenne Muscular Dystrophy (DMD) Phase 2 trial fully enrolled All patients will have completed first of three years on trial in Q1 2019 Initial data anticipated at end of Q1 2019 Pamrevlumab: Three High-Value, High-Need Indications

Slide 19

Pamrevlumab: Potential Innovative Treatment for Fibrosis and Fibroproliferative Diseases

Slide 20

Pamrevlumab Idiopathic Pulmonary Fibrosis

Slide 21

IPF Patients Need New Therapeutic Options 1 Raghu 2006 and United Nations Population Division 2 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3848422/ Slow pulmonary function loss Modest effect on slowing disease progression No demonstration of reversal Require side effect management ~$1.8B 2017 sales U.S. prevalence of ~44,000 to 135,0001 U.S. incidence of ~21,000 to 52,0001 cases per year Incident and mortality are on the rise, and prevalence is expected to increase with the aging population2 PROGRESSIVE Leads to irreversible loss of lung function with high morbidity and mortality rates Median survival of 3-5 years following diagnosis ORPHAN DISEASE CURRENT TREATMENTS !

Slide 22

Patient Population IPF patients who are not being treated with approved therapies IPF diagnosis according to ATS/ERS/JRS/ALAT guidelines* Study Design Placebo-controlled, double-blind Similar to PRAISE Phase 2b study Enroll ~500 patients Randomization 3:2 pamrevlumab or placebo Primary Endpoint Change in forced vital capacity (FVC) from baseline Secondary Endpoints Composite clinical outcome of disease progression Patient reported outcomes Quantitative changes in lung fibrosis volume from baseline Others Pamrevlumab IPF Phase 3 Study Design   *Raghu, 2018

Slide 23

PRAISE Phase 2 double-blind, placebo-controlled study (n=103) Met primary endpoint of change in FVC % predicted from baseline to Week 48 Average decline in FVC by Week 48 was significantly less in pamrevlumab arm Significantly smaller proportion of patients in the pamrevlumab arm experienced disease progression (FVC % predicted decline ≥10% or death) Statistically significant attenuation of fibrosis change by qHRCT vs. placebo at Weeks 24 and 48 Strong trends for improvement in health-related quality of life (HRQoL) relative to placebo Pamrevlumab IPF Program: Positive Phase 2 Results

Slide 24

Pamrevlumab Pancreatic Cancer

Slide 25

LAPC Patient Population Lacks Treatment Options 1 2018 Estimates: http://seer.cancer.gov/statfacts/html/pancreas.html ADDRESSING UNDERSERVED, GROWING, AND EMERGENT PATIENT POPULATIONS new U.S. patients Dx annually1 Clinical significance of resection 55K ~27,700 (50%) present with no detectable metastases ~9,700 (15-20%) classified as resectable ~18,000 (30-35%) with locally advanced disease that precludes resection Locally advanced disease 50% survive 8-12 months ~8% survive 5 years Survival rate similar to metastatic disease Borderline and resectable disease 50% survive 17-27 months ~20% survive 5 years

Slide 26

Patient Population Locally advanced, unresectable pancreatic cancer ECOG 0-1 No prior therapy Study Design Double-blind, placebo-controlled Enroll ~260 subjects at 40-60 sites globally Randomization 1:1 pamrevlumab + gemcitabine/nab-paclitaxel or placebo + gemcitabine/nab-paclitaxel 6 cycles of neoadjuvant treatment followed by evaluation for surgical eligibility and possible resection Long-term follow-up for survival in all subjects Primary Endpoint: Overall survival (OS) Interim Analysis: After 6 months treatment, if pamrevlumab arm shows improved resection rate over placebo arm, we may request FDA meeting to discuss Accelerated Approval Secondary Endpoints: Progression-free survival, patient reported outcomes, and others LAPC Pivotal Phase 3 Study Design

Slide 27

Pancreatic Cancer Program: Positive Clinical Results Reported from Phase 1/2 Studies STUDY 069 IN LOCALLY ADVANCED UNRESECTABLE PANCREATIC CANCER* Resection results: Higher proportion of patients in pamrevlumab arm: Eligible for surgical exploration 70.8% vs.15.4% (pamrevlumab vs. control, respectively) Achieved tumor resection 33.3% vs. 7.7% (pamrevlumab vs. control) Survival results: Statistically significant improvement of median survival in those who undergo resection Median survival for patients with non-resected tumors was 18.6 months Median survival for patients with resected tumors was >40 months (median not reached) *069 study ongoing

Slide 28

Pamrevlumab Duchenne Muscular Dystrophy

Slide 29

Affects ~1 in every 5,000 newborn boys About 20,000 children are diagnosed with DMD globally each year The fatal disease is caused by genetic mutations leading to the absence or defect of dystrophin, a protein necessary for normal muscle function. The absence of dystrophin results in muscle weakness, muscle loss, fibrosis, and inflammation Patients with DMD are often non-ambulatory before the age of 12, and their progressive muscle weakness may lead to serious medical problems relating to diminished function of respiratory and cardiac muscles DMD Background

Slide 30

Design Open-label, single-arm study in 21 non-ambulatory boys, 12 years of age and older Objective Efficacy, safety and tolerability, and PK Endpoints Change from baseline in: Pulmonary function tests Upper body muscle function tests Muscle and cardiac fibrosis by MRI imaging Study Status Fully enrolled and treatment is ongoing One-Year Data Anticipated in Q1 2019 Pamrevlumab DMD Program

Slide 31

CKD Anemia U.S. / ROW Pooled MACE safety data analysis (dialysis, non-dialysis) anticipated in the first half of 2019 NDA submission to FDA for the treatment of anemia in dialysis-dependent and non-dialysis-dependent CKD patients anticipated in the first half of 2019 CKD Anemia China Regulatory approval for CKD non-dialysis anticipated in the first half of 2019 Roxadustat launch in CKD dialysis-dependent and non-dialysis dependent anticipated in the second half of 2019 Upcoming Roxadustat Milestones

Slide 32

Idiopathic Pulmonary Fibrosis Plan to commence Phase 3 clinical study in the first quarter of 2019 Locally Advanced Unresectable Pancreatic Cancer Initiate Phase 3 clinical study in the first quarter of 2019 Duchenne Muscular Dystrophy Anticipate completing first year of treatment and reporting topline data in the first quarter of 2019 Upcoming Pamrevlumab Milestones

Slide 33

Thank you