Millendo Therapeutics Reports Third Quarter 2019 Operating and Financial Results
ANN ARBOR, Mich.--(BUSINESS WIRE)--Nov 13, 2019--
Millendo Therapeutics, Inc. (Nasdaq: MLND), a clinical-stage biopharmaceutical company primarily focused on developing novel treatments for orphan endocrine diseases with significant unmet needs, today provided a corporate update and reported financial results for the quarter ended September 30, 2019.
“With the Phase 2b portion of our ZEPHYR pivotal Phase 2b/3 clinical study of livoletide in PWS patients now fully recruited for patients ages 8 to 65, we look forward to reporting topline results in the first half of 2020,” said Julia C. Owens, President and Chief Executive Officer of Millendo Therapeutics. “We are excited about the potential for livoletide to treat hyperphagia and other food-seeking behaviors that lead to morbidity and mortality in these patients, as well as significant caregiver burden.
“In addition, our Phase 2b clinical study of nevanimibe in CAH is continuing recruitment across its two cohorts, providing us with further insights on the activity of nevanimibe over longer treatment periods and in CAH patients where steroid doses are reduced. We expect to report topline results from the study’s first cohort in the second half of 2020.”
Third Quarter 2019 and Recent Highlights
Third Quarter 2019 Financial Results
Cash Position: Cash, cash equivalents, marketable securities and restricted cash were $48.3 million at September 30, 2019, compared to $78.2 million at December 31, 2018.
Research and Development (R&D) Expenses: R&D expenses were $7.3 million for the third quarter of 2019, as compared to $3.9 million for the same period in 2018. The increase in R&D expenses was primarily driven by increased spending on the company’s pivotal Phase 2b/3 study of livoletide in PWS and higher compensation expenses as a result of increased headcount.
General and Administrative (G&A) Expenses: G&A expenses were $4.4 million for the third quarter of 2019, as compared to $3.9 million for the same period in 2018. The increase in G&A expenses was primarily driven by higher compensation expense as a result of increased headcount and increased expenses to support ongoing business operations and obligations associated with being a publicly traded company.
Net Loss: The company’s net loss for the quarter ended September 30, 2019 was $11.6 million as compared to $7.9 million for the same period in 2018.
2019 Financial Guidance
Millendo expects that its cash, cash equivalents, marketable securities and restricted cash will support the company’s capital needs through the fourth quarter of 2020, beyond the readout for the topline results of the Phase 2b portion of the pivotal Phase 2b/3 study of livoletide in PWS, which is expected in the first half of 2020. This cash runway guidance is based on the company’s current operational plans and excludes any additional funding or business development activities.
Livoletide is an unacylated ghrelin analogue in late-stage clinical development for the treatment of Prader-Willi syndrome (PWS), a rare genetic disease characterized by hyperphagia, a chronic unrelenting hunger, that leads to obesity, metabolic dysfunction, reduced quality of life and early mortality. In a previous randomized, double-blind, placebo-controlled Phase 2 clinical trial in 47 patients with PWS, administration of livoletide once daily for two weeks was associated with a clinically meaningful improvement in hyperphagia, as well as a reduction in appetite. Millendo has received both Orphan Drug Designation and Fast Track Designation for livoletide for the treatment of PWS from the U.S. Food and Drug Administration (FDA) and Orphan Drug Designation from the European Medicines Agency (EMA). For more information about Millendo’s pivotal study of livoletide (ZEPHYR) please visit www.clinicaltrials.gov ( NCT03790865 ) or the Patients and Families portion of our website.
About the ZEPHYR study
The ZEPHYR study is a two-part, randomized, double-blind, placebo-controlled pivotal Phase 2b/3 study. The first part is a Phase 2b study that includes a three-month double-blind, placebo-controlled core period in which patients receive one of two doses of livoletide or placebo followed by a nine-month extension period in which all patients receive livoletide. The Phase 2b portion of the study, one of the largest global PWS studies ever conducted, has completed recruitment for patients ages 8 to 65 with over 150 patients across 38 clinical sites in the United States, Europe and Australia. Millendo continues to implement a protocol amendment globally adding an additional cohort of PWS patients ages four to seven. Sites that recruit pediatric patients will continue to actively recruit patients for this cohort. The second part is a Phase 3 study that will consist of a six-month double-blind, placebo-controlled core period in which patients will receive livoletide or placebo followed by a six-month extension period in which all patients receive livoletide. The study’s primary endpoint measures the change in food-related behaviors using the validated Hyperphagia Questionnaire for Clinical Trials (HQ-CT) during each core period. ZEPHYR is a pivotal study and the results of the Phase 2b portion of the study may be sufficient to support a new drug application (NDA) for livoletide.
Nevanimibe decreases adrenal steroidogenesis through the inhibition of ACAT1 and is being studied for the treatment of classic congenital adrenal hyperplasia (CAH). CAH is a rare, monogenic adrenal disease that requires lifelong treatment with exogenous cortisol, often at high doses, which can make it difficult for physicians to appropriately treat CAH without causing adverse consequences. In a Phase 2 proof-of-concept clinical trial in patients with CAH, Millendo observed nevanimibe to be associated with clear signs of clinical activity in seven of 10 treated patients. A Phase 2b trial of nevanimibe in CAH ( NCT03669549 ) is ongoing.
About Millendo Therapeutics, Inc.
Millendo Therapeutics is a late-stage biopharmaceutical company primarily focused on developing novel treatments for orphan endocrine diseases where current therapies do not exist or are insufficient. As a leading orphan endocrine company, Millendo creates distinct and transformative treatments where there is a significant unmet medical need. The company is currently advancing livoletide for the treatment of Prader-Willi syndrome, nevanimibe for the treatment of classic congenital adrenal hyperplasia and MLE-301 for the treatment of vasomotor symptoms associated with menopause. For more information, please visit www.millendo.com.
Cautionary Statement Regarding Forward-Looking Statements
Certain statements contained in this press release regarding matters that are not historical facts, are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended and Section 21E of the Securities Exchange Act of 1934, as amended. These include statements regarding Millendo’s expectations regarding the potential for an NDA submission for livoletide, the timing for its clinical trials, including the timing of topline data from the Phase 2b portion of its ZEPHYR trial and timing of topline data from the first cohort from the Phase 2b clinical study of nevanimibe in CAH, and Millendo’s expectations regarding its cash runway, and, therefore, you are cautioned not to place undue reliance on them. In some cases, you can identify forward-looking statements by the words “may,” “might,” “will,” “could,” “would,” “should,” “expect,” “intend,” “plan,” “objective,” “anticipate,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue” and “ongoing,” or the negative of these terms, or other comparable terminology intended to identify statements about the future. Such forward-looking statements are based on Millendo’s expectations and involve risks and uncertainties; consequently, actual results may differ materially from those expressed or implied in the statements due to a number of factors, including that Millendo has incurred significant losses since inception, Millendo has a limited operating history and has never generated any revenue from product sales, Millendo will require additional capital to finance its operations, Millendo’s future success is dependent on the successful clinical development, regulatory approval and subsequent commercialization of livoletide, nevanimibe and any future product candidates, preclinical studies or earlier clinical trials are not necessarily predictive of future results and the results of Millendo’s clinical trials may not support Millendo’s livoletide or nevanimibe claims, Millendo may encounter substantial delays in its clinical trials or Millendo may fail to demonstrate safety and efficacy to the satisfaction of applicable regulatory authorities, enrollment and retention of patients in clinical trials is an expensive and time-consuming process and could be made more difficult or rendered impossible by multiple factors outside Millendo’s control, Millendo’s product candidates may cause undesirable side effects or have other properties that could delay or prevent their regulatory approval, or limit their commercial potential and Millendo faces substantial competition. You should refer to the risk factor disclosure set forth in the periodic reports and other documents we file with the Securities and Exchange Commission available at www.sec.gov, including our Quarterly Report on Form 10-Q for our fiscal quarter ended September 30, 2019 and subsequent reports that we file with the Securities and Exchange Commission.
New factors emerge from time to time and it is not possible for Millendo to predict all such factors, nor can Millendo assess the impact of each such factor on the business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements. Forward-looking statements included in this press release are based on information available to Millendo as of the date of this press release. Millendo disclaims any obligation to update such forward-looking statements to reflect events or circumstances after the date of this press release, except as required by applicable law.
Millendo Therapeutics, Inc.
Condensed Statements of Operations
(in thousands except share and per share amounts)
|Three Months Ended||Nine Months Ended|
|September 30,||September 30,|
|Research and development|
|General and administrative|
|Loss from operations|
|Other (income) expense, net|
|Net loss attributable to noncontrolling interest|
|Net loss attributable to common stockholders|
|Net loss per share of common stock, basic and diluted|
|Weighted-average shares of common stock outstanding, basic and diluted|
|Millendo Therapeutics, Inc.|
|Condensed Balance Sheet Data|
|September 30,||December 31,|
|Cash, cash equivalents, marketable securities and restricted cash|
|Total stockholders' equity|
|Total liabilities and stockholders' equity|
View source version on businesswire.com:https://www.businesswire.com/news/home/20191113005135/en/
CONTACT: Millendo Investor Contact:
Stern Investor Relations
Millendo Media Contact:
KEYWORD: UNITED STATES NORTH AMERICA MICHIGAN
INDUSTRY KEYWORD: BIOTECHNOLOGY PHARMACEUTICAL HEALTH CLINICAL TRIALS
SOURCE: Millendo Therapeutics
Copyright Business Wire 2019.
PUB: 11/13/2019 08:30 AM/DISC: 11/13/2019 08:31 AM