Werbe
4 years ago
MLE-301 is now dead. PPS seems to be baked in already?
Millendo Therapeutics, Inc. (the “Company”), a Delaware corporation, together with its subsidiaries, is a clinical stage biopharmaceutical company primarily focused on developing novel treatments for endocrine diseases where current therapies do not exist or are insufficient. The Company seeks to leverage its understanding of recent biological discoveries in endocrinology to continue to advance and build its pipeline in order to improve the lives of patients.
The Company has a selective neurokinin 3 receptor (NK3R) antagonist (MLE-301) in its research and development pipeline, which it is developing as a potential treatment of vasomotor symptoms (“VMS”), commonly known as hot flashes and night sweats, in menopausal women. The Company is also actively pursuing additional pipeline assets in treatment areas where it has knowledge and experience in developing drug product candidates. The Company seeks to identify assets that complement its current portfolio.
The Company had been developing livoletide (AZP-531) as a potential treatment for Prader-Willi syndrome (“PWS”), a rare and complex genetic endocrine disease characterized by hyperphagia, or insatiable hunger. The Company discontinued the development of livoletide as a potential treatment for PWS in April 2020 based upon results from its Phase 2b trial. All costs, including estimated closeout costs associated with the livoletide program were recognized during the second quarter, which resulted in the Company recording $3.1 million in the second quarter of 2020. The Company recorded additional expense in the third quarter of 2020 related to the livoletide program, which reflects changes to estimated closeout costs. The Company does not expect to incur future material expenses related to this program.
In an effort to streamline costs after discontinuing the PWS program, the Company eliminated employee positions representing approximately 30% of its prior headcount, which were completed in the second quarter of 2020. The Company recorded one-time costs of $1.1 million in the form of termination benefits related to this plan in the second quarter of 2020.
The Company had also been developing nevanimibe (ATR-101) as a potential treatment for patients with classic congenital adrenal hyperplasia, (“CAH”), a rare, monogenic adrenal disease that requires lifelong treatment with exogenous cortisol, often at high doses. The Company elected to cease investing in the development of nevanimibe as a potential treatment for CAH in June 2020 based on an interim review of data from its Phase 2b trial. All costs, including estimated closeout costs associated with the nevanimibe program for the treatment of CAH were recognized during the second quarter of 2020. The Company recorded additional expense in the third quarter of 2020 related to the nevanimibe program, which reflects changes to estimated close out costs. The Company does not expect to incur future material expenses related to this program.
Werbe
4 years ago
3 research operations killed now. SVB Leerink and them have been planning something IMO. I grabbed some 1.6s
ANN ARBOR, Mich., January 5, 2021 – Millendo Therapeutics, Inc. (Nasdaq: MLND), announced today that its Board of Directors has decided to discontinue further investment in MLE-301, a selective neurokinin 3 receptor (NK3R) antagonist for the treatment of menopausal vasomotor symptoms (VMS), based on an analysis of the pharmacokinetic and pharmacodynamic data from the ongoing single ascending dose portion of the Phase 1 study being conducted in healthy male volunteers. While MLE-301 was generally well-tolerated, the data do not support moving forward with its development in the target population of peri- and post-menopausal women, especially with the evolving dynamics of a highly competitive NK3R antagonist market.
Given the Company’s limited expected financing options, Millendo’s Board of Directors has determined that it is in the best interests of the Company’s shareholders to explore an expanded range of strategic alternatives that include, but are not limited to, the potential sale or merger of the Company or its assets. Millendo will continue working with SVB Leerink to assist in its ongoing strategic process.
Carol Gallagher, Chairman of the Board, commented, "We would like to acknowledge and thank all of our employees for their hard work in supporting Millendo’s mission of pursuing novel therapies to alleviate patient suffering due to endocrine diseases. The Board has continued to support the Company’s ongoing plans and execution efforts; however, at this time the Board believes that it is in the best interest of the Company and its shareholders to actively seek a broad range of strategic alternatives, including a sale or merger of the Company in order to maximize shareholder value.”
To conserve cash, Millendo intends to review its operating costs and may plan for a reduction in its workforce in order to focus its resources on essential business activities.
DMOST
5 years ago
Millendo Therapeutics to Participate in September Investor Conferences
Millendo Therapeutics, Inc. (MLND), a clinical-stage biopharmaceutical company developing novel treatments for orphan endocrine diseases, today announced that senior management will present company overviews and conduct one-on-one investor meetings at the following healthcare investor conferences:
Citi’s 14th Annual Biotech Conference
Date: Thursday, September 5, 2019 (one-on-one meetings only)
Location: Boston, MA
Oppenheimer Fall Summit Focused on Specialty Pharma & Rare Disease Companies
Date: Monday, September 23, 2019 (one-on-one meetings only)
Location: New York, NY
Ladenburg Thalmann 2019 Healthcare Conference
Date/Time: Tuesday, September 24, 2019 at 11:00 a.m. EDT
Location: New York, NY
A live webcast of the Ladenburg Thalmann presentation will be available on the Investors & Media section of Millendo’s website at http://investors.millendo.com. A replay of the webcast will be archived on Millendo’s website for 30 days following the presentation.
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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20190829005139/en/
GO MLND
"PEACE"
DMOST
5 years ago
Millendo Therapeutics Appoints Tamara Joseph as General Counsel and Ryan Zeidan as Chief Development Officer
ANN ARBOR, Mich.--(BUSINESS WIRE)--
–Strengthens leadership team to support continued advancement of novel therapeutics for rare and serious endocrine diseases–
Millendo Therapeutics, Inc. (MLND), a clinical-stage biopharmaceutical company primarily focused on developing novel treatments for orphan endocrine diseases with significant unmet needs, announced today the appointments of Tamara Joseph, JD, LLM, as General Counsel and Corporate Secretary and Ryan Zeidan, PhD, as Chief Development Officer. Ms. Joseph succeeds Jeffery M. Brinza who announced his retirement in March.
"We are pleased to welcome Tamara to our company and executive leadership team," said Julia C. Owens, PhD, President and Chief Executive Officer of Millendo Therapeutics. "As we continue to advance our portfolio of novel endocrine therapeutics, Tamara’s broad experience across public companies and the global biopharmaceutical industry, particularly in rare diseases, makes her an ideal addition to the Millendo team. We thank Jeff for his four years of service to the company and wish him well in his retirement.
“I am also excited to announce Ryan’s promotion to Chief Development Officer, recognizing the significant impact he has made since joining our company last year. Tamara and Ryan’s deep expertise and leadership will be critical to Millendo as we continue to build our development and commercial capabilities,” Dr. Owens added.
The company is currently conducting a pivotal Phase 2b/3 clinical study for its lead program, livoletide for the treatment of Prader-Willi syndrome, and a Phase 2b study of nevanimibe for the treatment of classic congenital adrenal hyperplasia. MLE-301, a preclinical asset for the treatment of vasomotor symptoms associated with menopause, is advancing toward the clinic.
“I was drawn to Millendo for its promising science, talented team, notable progress to date and the opportunity to bring therapies to patients suffering from serious endocrine diseases,” said Ms. Joseph. “I am thrilled to be joining Millendo at this exciting point in its lifecycle, and I look forward to working with Julia, Ryan and the entire team.”
Ms. Joseph joins Millendo with more than 20 years of leadership roles in multiple biotechnology companies, overseeing legal, compliance, public and government affairs, and risk management. She most recently served as General Counsel at Enzyvant Therapeutics and previously served as General Counsel at InVivo Therapeutics, Cubist Pharmaceuticals, Mayne Pharma, and Transkaryotic Therapies (TKT). She led Mayne Pharma’s team and advised its Board of Directors during the company’s acquisition by Hospira and advised TKT’s Board on that company’s acquisition by Shire. She also established and led the ex-US operations of the Biogen Idec legal and public affairs departments. Ms. Joseph received her bachelor’s degree in economics from Duke University, her JD from the University of Michigan Law School and her LLM degrees from the College of Europe in Belgium and the University of Paris.
Dr. Zeidan has served as Senior Vice President of Development at Millendo since joining the company in 2018. In this role he has overseen critical R&D functions including clinical operations, project management, CMC and regulatory affairs. Prior to Millendo, Dr. Zeidan was with Celgene, where he oversaw the development and advancement of two late-stage oncology assets to Phase 3 registration studies, and with Novartis Oncology, where he served as Executive Director, Global Strategy and Operations. Earlier, he worked at the Boston Consulting Group and Calando Pharmaceuticals. Dr. Zeidan holds a Ph.D. in chemistry and chemical engineering from the California Institute of Technology, and bachelor’s degrees in chemistry and chemical engineering from the Massachusetts Institute of Technology.
Inducement Equity Awards
On August 19, 2019, the Compensation Committee of the Board of Directors approved, effective as of August 19, 2019, the grant of an inducement stock option to purchase 130,000 shares of the Company’s common stock to Ms. Joseph. The stock option awarded to Ms. Joseph has an exercise price of $7.27 per share, the closing price per share of the Company’s common stock on August 19, 2019, and will vest and become exercisable over four years, with 25% of the shares vesting on August 19, 2020, the one-year anniversary of the vesting commencement date, and the remaining shares vesting ratably over the subsequent 36 months, subject to Ms. Joseph’s continued service with the Company. The stock option is subject to acceleration upon a change in control. The stock option has a ten-year term and is subject to the terms and conditions of the stock option agreement pursuant to which the option was granted.
The options were granted as inducements material to Ms. Joseph entering into employment with the Company in accordance with NASDAQ Listing Rule 5635(c)(4).
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 communication regarding matters that are not historical facts, are forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995, known as the PSLRA. These include statements regarding the transition of the general counsel office and management’s intentions, plans, beliefs, expectations or forecasts for the future, and, therefore, you are cautioned not to place undue reliance on them. No forward-looking statement can be guaranteed, and actual results may differ materially from those projected. Millendo undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise, except to the extent required by law. We use words such as “anticipates,” “believes,” “plans,” “expects,” “projects,” “future,” “intends,” “may,” “will,” “should,” “could,” “estimates,” “predicts,” “potential,” “continue,” “guidance,” and similar expressions to identify these forward-looking statements that are intended to be covered by the safe-harbor provisions of the PSLRA. Such forward-looking statements are based on our 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, but not limited to, risks related to changes in the composition of our management team and related transition. New factors emerge from time to time and it is not possible for us to predict all such factors, nor can we 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 release are based on information available to Millendo as of the date of this release. Millendo disclaims any obligation to update such forward-looking statements to reflect events or circumstances after the date of this release, except as required by applicable law.
View source version on businesswire.com: https://www.businesswire.com/news/home/20190820005214/en/
Contact:
Millendo Investor Contact:
Stephanie Ascher
Stern Investor Relations
212-362-1200
stephanie.ascher@sternir.com
Millendo Media Contact:
Betsy Yates
MacDougall
781-235-3094
byates@macbiocom.com
https://finance.yahoo.com/news/millendo-therapeutics-appoints-tamara-joseph-123000515.html
GO MLND
"PEACE"
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