"Following positive topline results from the primary analysis of the ROCKstar pivotal trial of belumosudil in cGVHD announced in
Upcoming Milestones:
Belumosudil (KD025)
- Submit New Drug Application (NDA) for belumosudil in chronic graft-versus-host disease (cGVHD) to the
U.S. Food and Drug Administration (FDA) in Q4 2020; the FDA has accepted belumosudil for review under its Real-Time Oncology Review (RTOR) pilot program, which aims to explore a more efficient review process to ensure safe and effective treatments are available to patients as early as possible - Continue ongoing discussions with the
European Medicines Agency (EMA) to determine a regulatory path forward for belumosudil in cGVHD; the Company plans to share 12-month data from the ROCKstar pivotal trial with the EMA, which will include key secondary endpoints such as Overall Survival and Failure-Free Survival; the Company expects to share an update on the path forward for belumosudil inEurope in 1H 2021 - Continue enrollment in ongoing placebo-controlled Phase 2 clinical trial in diffuse cutaneous systemic sclerosis (KD025-209); enrollment is delayed due to the COVID-19 pandemic
- Initiate small (12-15 patient), open-label Phase 2 clinical trial of belumosudil in patients with diffuse cutaneous systemic sclerosis in Q1 2021
KD033
- Continue enrollment in ongoing dose-escalation Phase 1 clinical trial of KD033, Kadmon's anti-PD-L1/IL-15 fusion protein, in patients with metastatic or locally advanced solid tumors
KD045
- Continue ongoing Investigational New Drug Application (IND)-enabling activities of KD045, Kadmon's next-generation ROCK inhibitor for the treatment of fibrotic diseases
Financial Results
Second Quarter 2020 Results
Loss from operations for the three and six months ended
The decrease in loss from operations for the six months ended
The increase in loss from operations for the three months ended
Liquidity and Capital Resources
At
About ROCKstar
ROCKstar (KD025-213) is an ongoing open-label trial of belumosudil (KD025) in adults and adolescents with cGVHD who have received at least two prior lines of systemic therapy. Patients were randomized to receive belumosudil (KD025) at 200 mg QD or 200 mg BID, enrolling 66 patients per arm. The primary endpoint of the study is Overall Response Rate (ORR). Statistical significance is achieved if the lower bound of the 95% CI of ORR exceeds 30%. The ORR endpoint was met at the interim analysis, conducted two months after completion of enrollment. At the study's primary analysis, conducted six months after completion of enrollment, belumosudil achieved ORRs of 73% and 74% in the respective arms. Kadmon plans to submit results from the ROCKstar primary analysis for presentation at an upcoming scientific meeting.
About Belumosudil (KD025)
Belumosudil (KD025) is a selective oral inhibitor of Rho-associated coiled-coil kinase 2 (ROCK2), a signaling pathway that modulates inflammatory response. The FDA has granted Breakthrough Therapy Designation for belumosudil for the treatment of patients with cGVHD who have received at least two prior lines of systemic therapy. The FDA has also granted Orphan Drug Designation to belumosudil for the treatment of cGVHD. The FDA has accepted belumosudil for review under its Real-Time Oncology Review (RTOR) pilot program, which aims to explore a more efficient review process to ensure safe and effective treatments are available to patients as early as possible. Belumosudil is also being studied in an ongoing Phase 2 clinical trial in adults with diffuse cutaneous systemic sclerosis (KD025-209).
About Kadmon
Kadmon is a clinical-stage biopharmaceutical company that discovers, develops and delivers transformative therapies for unmet medical needs. Our clinical pipeline includes treatments for immune and fibrotic diseases as well as immuno-oncology therapies.
Forward Looking Statements
This press release contains forward-looking statements. Such statements may be preceded by the words "may," "will," "should," "expects," "plans," "anticipates," "could," "intends," "targets," "projects," "contemplates," "believes," "estimates," "predicts," "potential" or "continue" or the negative of these terms or other similar expressions. Forward-looking statements involve known and unknown risks, uncertainties and other important 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. We believe that these factors include, but are not limited to, (i) the initiation, timing, progress and results of our preclinical studies and clinical trials, and our research and development programs; (ii) our ability to advance product candidates into, and successfully complete, clinical trials; (iii) the impact of the COVID-19 pandemic on our business, workforce, patients, collaborators and suppliers, including delays in anticipated timelines and milestones of our clinical trials and on various government agencies who we interact with and/or are governed by; (iv) our reliance on the success of our product candidates; (iv) the timing or likelihood of regulatory filings and approvals, especially in light of the COVID-19 pandemic; (v) our ability to expand our sales and marketing capabilities; (vi) our ability to expand our sales and marketing capabilities; (vii) the commercialization, pricing and reimbursement of our product candidates, if approved; (viii) the implementation of our business model, strategic plans for our business, product candidates and technology; (ix) the scope of protection we are able to establish and maintain for intellectual property rights covering our product candidates and technology; (x) our ability to operate our business without infringing the intellectual property rights and proprietary technology of third parties; (xi) costs associated with defending intellectual property infringement, product liability and other claims; (xii) regulatory developments in
Consolidated Statements of Operations - Unaudited
(in thousands, except share and per share data)
|
Three Months Ended | Six Months Ended | ||||||||||||||
|
||||||||||||||||
|
2020 | 2019 | 2020 | 2019 | ||||||||||||
Revenues
|
||||||||||||||||
Net sales
|
$ | 299 | $ | 47 | $ | 888 | $ | 114 | ||||||||
Other revenue
|
149 | 179 | 6,295 | 353 | ||||||||||||
Total revenue
|
448 | 226 | 7,183 | 467 | ||||||||||||
Cost of sales
|
162 | 45 | 490 | 76 | ||||||||||||
Write-down of inventory
|
622 | 932 | 906 | 932 | ||||||||||||
Gross profit
|
(336 | ) | (751 | ) | 5,787 | (541 | ) | |||||||||
Operating expenses:
|
||||||||||||||||
Research and development
|
16,516 | 15,108 | 29,390 | 30,099 | ||||||||||||
Selling, general and administrative
|
10,068 | 8,981 | 19,434 | 16,927 | ||||||||||||
Total operating expenses
|
26,584 | 24,089 | 48,824 | 47,026 | ||||||||||||
|
||||||||||||||||
Loss from operations
|
(26,920 | ) | (24,840 | ) | (43,037 | ) | (47,567 | ) | ||||||||
Total other (expense) income
|
(232 | ) | 34,000 | (13,412 | ) | 60,319 | ||||||||||
Income tax expense
|
- | - | - | - | ||||||||||||
Net (loss) income
|
$ | (27,152 | ) | $ | 9,160 | $ | (56,449 | ) | $ | 12,752 | ||||||
Deemed dividend on convertible preferred stock
|
518 | 508 | 1,035 | 1,023 | ||||||||||||
Net (loss) income attributable to common stockholders
|
$ | (27,670 | ) | $ | 8,652 | $ | (57,484 | ) | $ | 11,729 | ||||||
|
||||||||||||||||
Basic net (loss) income per share of common stock
|
$ | (0.17 | ) | $ | 0.07 | $ | (0.36 | ) | $ | 0.09 | ||||||
Diluted net (loss) income per share of common stock
|
$ | (0.17 | ) | $ | 0.07 | $ | (0.36 | ) | $ | 0.09 | ||||||
Weighted average basic shares of common stock outstanding
|
162,416,059 | 129,080,221 | 161,101,923 | 127,713,099 | ||||||||||||
Weighted average diluted shares of common stock outstanding
|
162,416,059 | 129,090,983 | 161,101,923 | 127,750,765 | ||||||||||||
Condensed Consolidated Balance Sheets - Unaudited
(in thousands)
|
||||||||
|
2020 | 2019 | ||||||
|
||||||||
Cash and cash equivalents
|
$ | 169,803 | $ | 139,597 | ||||
Other current assets
|
3,151 | 3,010 | ||||||
Investment, equity securities
|
12,492 | 41,997 | ||||||
Right of use lease asset
|
17,902 | 19,651 | ||||||
Other noncurrent assets
|
9,896 | 10,543 | ||||||
Total assets
|
$ | 213,244 | $ | 214,798 | ||||
|
||||||||
Current liabilities
|
30,138 | 28,742 | ||||||
Lease liability - noncurrent
|
17,689 | 19,759 | ||||||
Other long term liabilities
|
2,160 | 562 | ||||||
Total liabilities
|
49,987 | 49,063 | ||||||
Total stockholders' equity
|
163,257 | 165,735 | ||||||
Total liabilities and stockholders' equity
|
$ | 213,244 | $ | 214,798 | ||||
Contact Information
646.490.2989
ellen.cavaleri@kadmon.com
SOURCE:
accesswire.com
https://www.accesswire.com/600625/Kadmon-Provides-Business-Update-and-Reports-Second-Quarter-2020-Financial-Results