Achillion Reports Third Quarter 2018 Financial Results
- Completed enrollment of Phase 2 clinical trial of ACH-4471 in PNH as monotherapy -
- Interim data and strategic update planned for
“In my first full quarter as CEO, our priorities have been to strengthen the leadership team, improve clinical execution and create a data-driven, patient-centric portfolio strategy. This quarter we added several experienced executives including,
“In the third quarter we completed enrollment in our Phase 2 PNH monotherapy trial of ACH-4471, initiated ten additional clinical trial sites to support our C3G development program, and commenced development of a comprehensive portfolio strategy that we plan to communicate to investors in
Truitt continued, “Additionally, after 18 years with Achillion,
“Achillion has talented employees, a robust balance sheet and exciting prospects in its clinical development programs, and I look forward to its continued success,” said Fenton. “I am also excited to explore new opportunities in the next phase of my career.”
Third Quarter Financial Results
For the three months ended
For the three months ended
Non-cash stock compensation expense totaled
Nine Month Financial Results
For the nine months ended
General and administrative expenses were
Non-cash stock compensation expense totaled
The Company expects that research and development expense during the fourth quarter of 2018 will increase slightly as a result of increased clinical trial activity, and that general and administrative expenses during the fourth quarter of 2018 will be consistent with prior 2018 quarters. Annual total research and development expense is expected to be in the range of
ACH-4471, Complement Factor D Inhibitor for PNH and C3G
Achillion’s first generation oral factor D inhibitor, ACH-4471 is being evaluated for safety and efficacy with Phase 2 clinical programs in both paroxysmal nocturnal hemoglobinuria (PNH) and C3 glomerulopathy (C3G).
The PNH program consists of two trials: A Phase 2 clinical trial in untreated PNH patients where ACH-4471 is being assessed as a monotherapy; the second trial is Phase 2 clinical trial evaluating ACH-4471 in patients who are inadequately controlled or sub-optimally responding to eculizumab, which is a therapy for patients with PNH.
The C3G program consists of three currently recruiting Phase 2 clinical trials: a 14-day biomarker study, a six-month blinded, placebo-controlled study, and a 12-month open label study.
More information is available at http://www.achillion.com/patients-and-clinicians/
ACH-5228 and ACH-5548, Complement Factor D Inhibitors
ACH-5228 and ACH-5548 are next-generation oral factor D inhibitors currently in Phase 1 clinical trials. In preclinical studies, these compounds demonstrated enhanced potency as well as improved pharmacokinetic properties that may allow for a reduced dosing frequency.
Achillion plans to provide interim data on all open-label ACH-4471 clinical trials as well as Phase 1 safety and pharmacokinetics interim data from the single ascending dose trials of its next-generation factor D compounds, ACH-5228 and ACH-5548, on
Cautionary Note Regarding Forward-Looking Statements
This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other important factors that could cause actual results to differ materially from those indicated by such forward-looking statements. Achillion may use words such as “expect,” “anticipate,” “project,” “target,” “intend,” “plan,” “aim,” “believe,” “seek,” “estimate,” “can,” “could” “focus,” “will,” “look forward,” “goal,” “may,” “potential,” and similar expressions to identify such forward-looking statements. These forward-looking statements also include statements about: the potential benefits of factor D inhibition as a treatment for complement-mediated diseases; the potential benefits of, and indications for, Achillion’s compounds that inhibit factor D, including ACH-4471, ACH-5228 and ACH-5548; Achillion’s belief that its portfolio of compounds could expand factor D portfolio opportunities, provide strategic optionality or create significant value; Achillion’s expectations regarding the advancement of, and timeline for reporting results from, clinical trials of its product candidates as well as its ability to advance additional compounds; and other statements concerning Achillion’s strategic goals, efforts, plans, and prospects. Among the important factors that could cause actual results to differ materially from those indicated by such forward-looking statements are risks relating to, among other things, Achillion’s ability to: demonstrate in any current and future clinical trials the requisite safety, efficacy and combinability of its product candidates; advance the preclinical and clinical development of its complement factor D inhibitors under the timelines it projects in current and future preclinical studies and clinical trials; obtain and maintain patent protection for its product candidates and the freedom to operate under third party intellectual property; obtain and maintain necessary regulatory approvals, and the granting of orphan designation does not alter the standard regulatory requirements and process for obtaining such approval; establish commercial manufacturing arrangements; identify, enter into and maintain collaboration and other commercial agreements with third-parties; compete successfully in the markets in which it seeks to develop and commercialize its product candidates and future products; manage expenses; manage litigation; raise the substantial additional capital needed to achieve its business objectives; and successfully execute on its business strategies. These and other risks are described in the reports filed by Achillion with the
In addition, any forward-looking statement in this press release represents Achillion's views only as of the date of this press release and should not be relied upon as representing its views as of any subsequent date. Achillion disclaims any duty to update any forward-looking statement, except as required by applicable law.
|Investors & Media:
Brian Di Donato
Vice President, Investor Relations and
Achillion Pharmaceuticals, Inc.
Tel. (215) 709-3032
-- Financial Tables Attached --
|ACHILLION PHARMACEUTICALS INC. (ACHN)|
|Statements of Operations|
|(Unaudited, in thousands, except per share amounts)|
|Three Months Ended||Nine Months Ended|
|September 30,||September 30,|
|Research and development||13,137||15,620||39,279||49,368|
|General and administrative||4,152||4,843||16,560||15,853|
|Total operating expenses||17,364||20,463||57,739||65,221|
|Loss from operations||(17,364||)||(20,463||)||(57,739||)||(65,221||)|
|Other income (expense):|
|Net loss per share - basic and diluted||$||(0.12||)||$||(0.14||)||$||(0.39||)||$||(0.45||)|
|Weighted average shares outstanding - basic and diluted||138,586||137,375||138,344||136,947|
|(Unaudited, in thousands)|
|September 30,||December 31,|
|Cash, cash equivalents, marketable securities and interest receivable||$||283,138||$||331,845|
|Total stockholders' equity||280,506||324,515|
Source: Achillion Pharmaceuticals, Inc.