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Achaogen Reports Fourth Quarter and Full Year 2018 Financial Results and Provides Corporate Update
-- ZEMDRI’s once-daily 30-minute infusion facilitating usage in the outpatient setting --
-- Company’s recent restructuring aimed at conserving capital to continue assessment of strategic alternatives --
-- Conference call today at
“The team continues to make progress on our launch objectives including gaining formulary access, contracting with physician-owned outpatient infusion centers, and driving ZEMDRI adoption in key markets,” said
- ZEMDRI® (plazomicin) Launch: The commercial organization continues to focus on areas of promising initial sales uptake and building a foundation to support adoption of ZEMDRI. Leading indicators such as the number of formulary reviews and approvals, contracts signed with physician-owned outpatient infusion centers, and adoption of antibiotic susceptibility testing and therapeutic drug management continue to trend positively. To date, 75 percent of ZEMDRI use has been in the outpatient setting.
- Plazomicin Marketing Authorization Application (MAA): The Company has received the Day 120 List of Questions from the
European Medicines Agency(EMA) as part of the centralized review process of the MAA for plazomicin.
- C-Scape Oral Antibiotic Program: The Company’s second antibacterial candidate is ready to enter a new Phase 1 human pharmacology study based on in vitro and in vivo experiments with a revised drug product. C-Scape is designed for infections due to ESBL-producing Enterobacteriaceae.
- Review of Strategic Alternatives and Corporate Restructuring: The Company remains focused on the review of strategic alternatives and, to support this, recently initiated a further restructuring to reduce quarterly cash operating expenses to
$15 million to $17 millionper quarter, starting in the second quarter of 2019.
Fourth Quarter and Year 2018 Financial Results
Cash Position: At
Research and Development (R&D): R&D expenses in the fourth quarter of 2018 were
Selling, General and Administrative (SG&A): SG&A expenses in the fourth quarter of 2018 were
Restructuring Expenses: Restructuring expenses in the fourth quarter of 2018 were
Warrants and Derivative Liabilities: Change in warrant and derivative liabilities for the fourth quarter of 2018 was a
The Company will host a conference call and webcast today at
ZEMDRI is an aminoglycoside with once-daily dosing that has activity against certain Enterobacteriaceae. Achaogen's EPIC clinical trial successfully evaluated the safety and efficacy of ZEMDRI in adult patients with cUTI, including pyelonephritis. ZEMDRI was engineered to overcome aminoglycoside-modifying enzymes, the most common aminoglycoside-resistance mechanism in Enterobacteriaceae, and has in vitro activity against ESBL-producing, aminoglycoside-resistant, and carbapenem-resistant isolates. The Centers for Disease Control and Prevention has characterized ESBL-producing Enterobacteriaceae as a “serious threat” and carbapenem-resistant Enterobacteriaceae (CRE) as “nightmare bacteria,” which is an immediate public health threat that requires urgent and aggressive action.
Indications & Usage
ZEMDRI (plazomicin) is indicated in patients 18 years of age or older for the treatment of complicated urinary tract infections (cUTI), including pyelonephritis caused by the following susceptible microorganism(s): Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, and Enterobacter cloacae.
As only limited clinical safety and efficacy data for ZEMDRI are currently available, reserve ZEMDRI for use in cUTI patients who have limited or no alternative treatment options.
To reduce the development of drug-resistant bacteria and maintain effectiveness of ZEMDRI and other antibacterial drugs, ZEMDRI should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible microorganisms.
Important Safety Information
BOXED WARNINGS: NEPHROTOXICITY, OTOTOXICITY, NEUROMUSCULAR BLOCKADE AND FETAL HARM
- Nephrotoxicity has been reported with ZEMDRI. The risk of nephrotoxicity is greater in patients with impaired renal function, the elderly, and in those receiving concomitant nephrotoxic medications. Assess creatinine clearance in all patients prior to initiating therapy and daily during therapy. Therapeutic Drug Monitoring (TDM) is recommended for complicated urinary tract infection (cUTI) patients with CLcr less than 90 mL/min to avoid potentially toxic levels.
- Ototoxicity, manifested as hearing loss, tinnitus, and/or vertigo, has been reported with ZEMDRI. Symptoms of aminoglycoside-associated ototoxicity may be irreversible and may not become evident until after completion of therapy. Aminoglycoside-associated ototoxicity has been observed primarily in patients with a family history of hearing loss, patients with renal impairment, and in patients receiving higher doses and/or longer durations of therapy than recommended.
- Aminoglycosides have been associated with neuromuscular blockade. During therapy with ZEMDRI, monitor for adverse reactions associated with neuromuscular blockade, particularly in high-risk patients, such as patients with underlying neuromuscular disorders (including myasthenia gravis) or in patients concomitantly receiving neuromuscular blocking agents.
- Aminoglycosides, including ZEMDRI, can cause fetal harm when administered to a pregnant woman.
Contraindications: ZEMDRI is contraindicated in patients with known hypersensitivity to any aminoglycoside.
Additional Warnings and Precautions
- Nephrotoxicity: Reported with the use of ZEMDRI. Most serum creatinine increases were ≤ 1 mg/dL above baseline and reversible. Assess CLcr in all patients prior to initiating therapy and daily during therapy with ZEMDRI, particularly in those at increased risk of nephrotoxicity, such as those with renal impairment, the elderly and those receiving concomitant potentially nephrotoxic medications. In the setting of worsening renal function, the benefit of continuing ZEMDRI should be assessed. Adjust the initial dosage regimen in cUTI patients with CLcr ≥ 15 mL/min and < 60 mL/min. For subsequent doses, TDM is recommended for patients with CLcr ≥ 15 mL/min and < 90 mL/min.
- Ototoxicity: Reported with ZEMDRI (manifested as hearing loss, tinnitus, and/or vertigo). Symptoms of aminoglycoside-associated ototoxicity may be irreversible and may not become evident until after completion of therapy. Aminoglycoside-associated ototoxicity has been observed primarily in patients with a family history of hearing loss (excluding age-related hearing loss), patients with renal impairment, and in patients receiving higher doses and/or for longer periods than recommended. The benefit-risk of ZEMDRI therapy should be considered in these patients.
- Neuromuscular Blockade: Aminoglycosides have been associated with exacerbation of muscle weakness in patients with underlying neuromuscular disorders, or delay in recovery of neuromuscular function in patients receiving concomitant neuromuscular blocking agents. During therapy with ZEMDRI, monitor for adverse reactions associated with neuromuscular blockade, particularly in high-risk patients, such as patients with underlying neuromuscular disorders (including myasthenia gravis) or those patients concomitantly receiving neuromuscular blocking agents.
- Fetal Harm: Aminoglycosides, including ZEMDRI, can cause fetal harm when administered to a pregnant woman. Patients who use ZEMDRI during pregnancy, or become pregnant while taking ZEMDRI should be apprised of the potential hazard to the fetus.
- Hypersensitivity Reactions: Serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported in patients receiving aminoglycoside antibacterial drugs. Before therapy with ZEMDRI is instituted, careful inquiry about previous hypersensitivity reactions to other aminoglycosides should be made. Discontinue ZEMDRI if an allergic reaction occurs.
- Clostridium difficile-Associated Diarrhea (CDAD): Reported for nearly all systemic antibacterial drugs and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial drugs alters the normal flora of the colon and may permit overgrowth of C. difficile. Careful medical history is necessary. If CDAD is suspected or confirmed, antibacterial drugs not directed against C. difficile may need to be discontinued.
- Development of Drug-Resistant Bacteria: Prescribing ZEMDRI in the absence of a proven or strongly suspected bacterial infection is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.
Please click here to see the full Prescribing Information, including BOXED WARNINGS, for additional Important Safety Information.
You may report side effects to the
Achaogen is a biopharmaceutical company passionately committed to the discovery, development, and commercialization of innovative antibacterial treatments for MDR gram negative infections. Achaogen’s first commercial product is ZEMDRI, for the treatment of adults with complicated urinary tract infections, including pyelonephritis. The Achaogen ZEMDRI program was funded in part with federal funds from the Biomedical Advanced Research and Development Authority (BARDA). The Company is currently developing C-Scape, an orally administered beta-lactam/beta-lactamase inhibitor combination, which is also supported by BARDA. C-Scape is investigational, has not been determined to be safe or efficacious, and has not been approved for commercialization. For more information, visit the
This press release contains forward-looking statements. All statements other than statements of historical facts contained herein are forward-looking statements reflecting the current beliefs and expectations of management made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to,
© 2019 Achaogen, Inc. All Rights Reserved.
|Consolidated Statements of Operations|
|(in thousands except share and per share data)|
|Three Months Ended||Twelve Months Ended|
|December 31,||December 31,|
|Product revenue, net||$||492||$||—||$||783||$||—|
|Cost of sales||20||-||31||-|
|Research and development||13,386||29,485||102,959||95,598|
|Selling, general and administrative||16,901||14,488||71,385||41,903|
|Total operating expenses||45,881||43,973||197,893||137,501|
|Loss from operations||(43,856||)||(42,103||)||(189,165||)||(126,326||)|
|Change in warrant and derivative liabilities||2,143||5,885||9,053||1,928|
|Loss on debt extinguishment||—||—||(819||)||—|
|Loss on redeemable common stock settlement||(5,179||)||—||(5,179||)||—|
|Other income, net||147||522||1,710||1,635|
|Net loss per common share:|
|Weighted-average shares used to compute net loss per common share|
|Consolidated Balance Sheets|
|December 31, 2018||December 31, 2017|
|Cash and cash equivalents||$||30,956||$||145,219|
|Trade and contract receivables, net||1,861||1,357|
|Assets held for sale||1,509||—|
|Prepaids and other current assets||1,412||6,367|
|Total current assets||61,253||178,406|
|Property and equipment, net||2,471||14,810|
|Non-current restricted cash||530||3,855|
|Other long-term assets||9,190||—|
|Liabilities, contingently redeemable common stock and stockholders’ equity (deficit)|
|Loan payable, current portion||49,784||12,500|
|Total current liabilities||78,451||36,903|
|Loan payable, long-term||—||9,457|
|Derivative liability, long-term||—||686|
|Contingently redeemable common stock||—||10,000|
|Stockholders’ equity (deficit)||(6,287||)||121,962|
|Total liabilities, contingently redeemable common stock and stockholders’ equity (deficit)||$||82,290||$||197,071|
Media and Investor Contact
Denise T. Powell Red House Consulting, LLCdenise@redhousecomms.com
Source: Achaogen, Inc.