MLND Millendo Therapeutics Inc.

1.66
-0.02  -1%
Previous Close 1.68
Open 1.71
52 Week Low 1.26
52 Week High 12
Market Cap $31,539,504
Shares 18,999,701
Float 18,893,368
Enterprise Value $-22,199,503
Volume 438,660
Av. Daily Volume 1,726,156
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Drug Pipeline

Drug Stage Notes
Nevanimibe
Congenital adrenal hyperplasia (CAH)
Phase 2b
Phase 2b
Phase 2b interim review completed. Development to be discontinued - June 23, 2020.
MLE-301
Vasomotor symptoms (VMS)
Phase 1
Phase 1
Phase 1 trial to commence 3Q 2020.
Livoletide
Prader-Willi syndrome (PWS)
Phase 2b
Phase 2b
Phase 2b data did not meet primary endpoint - April 6, 2020.

Latest News

  1. – MLE-301, a selective neurokinin 3 receptor (NK3R) antagonist, advancing with first-in-human trials expected to initiate in 3Q20 –

    – Further investment in nevanimibe for congenital adrenal hyperplasia (CAH) not planned following interim data review –

    – Strategic evaluation in place to determine future corporate strategy –

    Millendo Therapeutics, Inc. (NASDAQ:MLND), a biopharmaceutical company primarily focused on developing novel treatments for endocrine diseases with significant unmet needs, announced today that it has taken steps forward in its evaluation of strategic options to determine the company's future direction. As part of these efforts, Millendo has engaged SVB Leerink to support the strategic review process. The company finished…

    – MLE-301, a selective neurokinin 3 receptor (NK3R) antagonist, advancing with first-in-human trials expected to initiate in 3Q20 –

    – Further investment in nevanimibe for congenital adrenal hyperplasia (CAH) not planned following interim data review –

    – Strategic evaluation in place to determine future corporate strategy –

    Millendo Therapeutics, Inc. (NASDAQ:MLND), a biopharmaceutical company primarily focused on developing novel treatments for endocrine diseases with significant unmet needs, announced today that it has taken steps forward in its evaluation of strategic options to determine the company's future direction. As part of these efforts, Millendo has engaged SVB Leerink to support the strategic review process. The company finished Q1 2020 with $58.9 million in cash, cash equivalents and restricted cash.

    "Our board of directors and leadership team recognize the importance of conducting a comprehensive and strategic review. We are aligned in our focus on evaluating our pipeline and its potential, beginning with the advancement of MLE-301," said Julia C. Owens, President and Chief Executive Officer of Millendo Therapeutics. "Our objective is to come away from this process with an actionable plan that leverages our assets, capital and capabilities in a way that maximizes shareholder value."

    MLE-301, a selective neurokinin 3 receptor (NK3R) antagonist, continues to advance to first-in-human trials: An IND has been filed to study MLE-301 for the treatment of vasomotor symptoms (VMS), also known as hot flashes and night sweats, in menopausal women. VMS currently impact 70% of peri/post-menopausal women, representing over 20 million women in the US. Phase 1 clinical studies are expected to initiate in 3Q20.

    Interim review of nevanimibe open-label Phase 2b study in CAH completed: Results from 10 subjects, nine from cohort 1 and one from cohort 2, with at least 12 weeks of treatment with nevanimibe in this open-label, continuous dose escalation study showed that one patient (10%) met the primary endpoint of achieving 17-hydroxyprogesterone (17-OHP) levels less than or equal to 2-times the upper limit of normal (ULN). Treatment under the amended protocol with dose titration starting at 500 mg BID improved tolerability of nevanimibe. However, based on the observed level of nevanimibe activity and the changing competitive environment, no further investment in the program is currently planned.

    About MLE-301

    MLE-301 is a neurokinin 3 receptor (NK3R) antagonist that is being developed as a potential treatment of vasomotor symptoms (VMS), commonly known as hot flashes and night sweats, in menopausal women. NK3R plays a key role in regulating the activity of KNDy (kisspeptin/NKB/dynorphin) neurons, which are believed to participate in the generation of VMS. By inhibiting the NK3R signaling on the KNDy neurons and potentially other NK3R-expressing neurons that propagate heat dissipation signals through the hypothalamus, MLE-301 aims to reduce the effects of hyperactive KNDy neurons and thereby address vasomotor symptoms.

    About Nevanimibe

    Nevanimibe decreases adrenal steroidogenesis through the inhibition of acyl coenzyme A: cholesterol acyltransferase 1, or 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. These chronic high doses of cortisol can result in side effects that include diabetes, obesity, hypertension and psychological problems. An interim review of data from the Phase 2b trial of nevanimibe in CAH (NCT03669549) was conducted; results from 10 subjects with at least 12 weeks of treatment with nevanimibe in the open-label, continuous dose escalation study showed that one patient (10%) met the primary endpoint of achieving 17-hydroxyprogesterone (17-OHP) levels less than or equal to 2-times the upper limit of normal (ULN).

    About Millendo Therapeutics, Inc.

    Millendo Therapeutics is a biopharmaceutical company primarily focused on developing novel treatments for endocrine diseases where current therapies do not exist or are insufficient. Millendo seeks to create distinct and transformative treatments where there is a significant unmet medical need. The company is currently advancing 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. 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. These include statements with respect Millendo's strategic review and results thereof, Millendo's financial condition, Millendo's future capital needs, the impact of Millendo's plan to not further invest in the nevanimibe program, Millendo's timeline for the continued development of MLE-301 for menopausal vasomotor symptoms, and, therefore, you are cautioned not to place undue reliance on them. 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 current 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 product candidate 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, Millendo faces substantial competition and Millendo's business, preclinical studies and clinical development programs and timelines, its financial condition and results of operations could be materially and adversely affected by the current COVID-19 pandemic. You should refer to the risk factor disclosure set forth in the periodic reports and other documents Millendo files with the Securities and Exchange Commission available at www.sec.gov, including without limitation Millendo's Quarterly Report on Form 10-Q for the fiscal quarter ended March 31, 2020.

    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.

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  2. Millendo Therapeutics, Inc. (NASDAQ:MLND), a clinical stage biopharmaceutical company primarily focused on developing novel treatments for endocrine diseases with significant unmet needs, today provided a corporate update and reported financial results for the quarter ended March 31, 2020.

    "As we wind down activities related to the livoletide program, we have moved quickly to streamline costs and redeploy development efforts to our other portfolio programs, nevanimibe for congenital adrenal hyperplasia and MLE-301 for menopausal vasomotor symptoms," said Julia C. Owens, President and Chief Executive Officer of Millendo Therapeutics. "We are currently evaluating our business strategy, taking into consideration our existing pipeline assets…

    Millendo Therapeutics, Inc. (NASDAQ:MLND), a clinical stage biopharmaceutical company primarily focused on developing novel treatments for endocrine diseases with significant unmet needs, today provided a corporate update and reported financial results for the quarter ended March 31, 2020.

    "As we wind down activities related to the livoletide program, we have moved quickly to streamline costs and redeploy development efforts to our other portfolio programs, nevanimibe for congenital adrenal hyperplasia and MLE-301 for menopausal vasomotor symptoms," said Julia C. Owens, President and Chief Executive Officer of Millendo Therapeutics. "We are currently evaluating our business strategy, taking into consideration our existing pipeline assets, assessing the evolving impact of the global COVID-19 pandemic and leveraging the deep development expertise of our leadership team to investigate potential strategic additions to our portfolio."

    First Quarter 2020 and Recent Highlights

    • Discontinuation of the livoletide program in Prader-Willi syndrome (PWS): Topline data from the Phase 2b ZEPHYR study of livoletide in PWS were announced on April 6, 2020, and showed that treatment with livoletide did not result in a statistically significant improvement in hyperphagia and food-related behaviors compared to placebo, as measured by the Hyperphagia Questionnaire for Clinical Trials. As a result, the company discontinued the program and initiated staffing reductions. Final data tables and listings are currently being reviewed but are not anticipated to alter the topline conclusions of the study.
    • Interim review of data expected by 3Q20 for ongoing Phase 2b study of nevanimibe in patients with classic congenital adrenal hyperplasia (CAH): Due to the continued global COVID-19 pandemic, new patients are not being actively enrolled in the open-label, Phase 2b nevanimibe study in CAH at this time, as is the case for many clinical studies worldwide. The company expects to conduct an interim review of the current dataset for enrolled patients by 3Q20.
    • MLE-301 expected to initiate Phase 1 clinical trials in 2H20 as planned: A selective neurokinin 3 receptor (NK3R) antagonist, MLE-301 is intended for the treatment of vasomotor symptoms (VMS), commonly known as hot flashes and night sweats, in menopausal women. Due to the well-established role of NK3R in VMS, MLE-301 may have meaningful potential in an area of high unmet medical need.

    First Quarter 2020 Financial Results

    Cash Position: Cash, cash equivalents and restricted cash were $58.9 million at March 31, 2020, compared to $63.5 million at December 31, 2019.

    Research and Development (R&D) Expenses: R&D expenses were $7.5 million for the first quarter 2020, as compared to $6.2 million for the same period in 2019. The increase in R&D expenses was primarily driven by increased spending on the company's Phase 2b study of livoletide in PWS, which has since been discontinued.

    General and Administrative (G&A) Expenses: G&A expenses were $4.6 million for the first quarter 2020, as compared to $4.5 million for the same period in 2019. The increase in G&A expenses was primarily driven by increased costs related to employee compensation offset by lower professional fees as compared to the prior period.

    Net Loss: The company's net loss for the quarter ended March 31, 2020 was $12.0 million as compared to $10.4 million for the same period in 2019.

    2020 Financial Guidance

    Millendo expects that its cash, cash equivalents and restricted cash will support the company's current development and operational plans into 2022.

    About Nevanimibe

    Nevanimibe decreases adrenal steroidogenesis through the inhibition of acyl coenzyme A: cholesterol acyltransferase 1, or 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. These chronic high doses of cortisol can result in side effects that include diabetes, obesity, hypertension and psychological problems. Millendo has received Orphan Drug Designation for nevanimibe for the treatment of CAH from the U.S. Food and Drug Administration and the European Medicines Agency. In a Phase 2a 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 MLE-301

    MLE-301 is a neurokinin 3 receptor (NK3R) antagonist that is being developed as a potential treatment of VMS, commonly known as hot flashes and night sweats, in menopausal women. NK3R plays a key role in regulating the activity of KNDy (kisspeptin/NKB/dynorphin) neurons, which are believed to participate in the generation of VMS. By inhibiting the NK3R signaling on the KNDy neurons and potentially other NK3R-expressing neurons that propagate heat dissipation signals through the hypothalamus, MLE-301 aims to reduce the effects of hyperactive KNDy neurons and thereby address the excessive heat dissipation signaling associated with VMS. MLE-301 is currently in preclinical studies designed to enable first-in-human clinical studies.

    About Millendo Therapeutics, Inc.

    Millendo Therapeutics is a clinical stage biopharmaceutical company primarily focused on developing novel treatments for endocrine diseases where current therapies do not exist or are insufficient. Millendo seeks to create distinct and transformative treatments where there is a significant unmet medical need. The company is currently advancing 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. 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. These include statements with respect to the impact of the COVID-19 pandemic on Millendo's business, preclinical studies and clinical development programs and timelines, Millendo's financial condition and results of operations, Millendo's future capital needs, the impact of Millendo's discontinuation of the PWS program, Millendo's plans to potentially in-license, acquire and develop additional product candidates and the timelines for the continued development of nevanimibe for congenital adrenal hyperplasia and MLE-301 for menopausal vasomotor symptoms, and, therefore, you are cautioned not to place undue reliance on them. 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 current 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 product candidate 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, Millendo faces substantial competition and Millendo's business, preclinical studies and clinical development programs and timelines, its financial condition and results of operations could be materially and adversely affected by the current COVID-19 pandemic. You should refer to the risk factor disclosure set forth in the periodic reports and other documents Millendo files with the Securities and Exchange Commission available at www.sec.gov, including without limitation Millendo's Annual Report on Form 10-K for the fiscal year ended December 31, 2019, Millendo's Current Report on Form 8-K filed on April 6, 2020 and Millendo's Quarterly Report on Form 10-Q for the fiscal quarter ended March 31, 2020.

    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
    (Unaudited)    
    (in thousands except share and per share amounts)
       
      Three Months Ended
      March 31,
     

    2020

     

    2019

    Operating Expenses    
    Research and development  

     $

            7,540

     

     

     $

            6,204

    General and administrative  

     

               4,595

     

     

     

               4,453

    Loss from operations  

     

             12,135

     

     

     

             10,657

     

       
    Other (income) expense, net  

     

                (137

    )

     

     

                (291

    )

    Net loss  

     $

         (11,998

    )

     

     $

         (10,366

    )

    Net loss per share of common stock, basic and diluted  

     $

            (0.65

    )

     

     $

            (0.78

    )

    Weighted-average shares of common stock outstanding, basic and diluted  

     

      18,448,507

     

     

     

      13,357,999

     

       
       
    Millendo Therapeutics, Inc.
    Condensed Balance Sheet Data
    (Unaudited)    
    (in thousands)
       
      March 31,   December 31,
     

    2020

     

    2019

    Cash, cash equivalents and restricted cash  

     $

          58,877

     

     

     $

          63,512

     

    Other assets  

     

               9,168

     

     

     

             11,458

     

    Total assets  

     $

          68,045

     

     

     $

          74,970

     

       
    Total liabilities  

     $

          13,406

     

     

     $

          15,099

     

    Total stockholders' equity  

     

             54,639

     

     

     

             59,871

     

    Total liabilities and stockholders' equity  

     $

          68,045

     

     

     $

          74,970

     

     

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  3. –Topline results from pivotal Phase 2b study of livoletide in patients with Prader-Willi syndrome (PWS) expected in early 2Q20–

    –Topline results from first cohort of Phase 2b study of nevanimibe in patients with classic congenital adrenal hyperplasia (CAH) expected in 2H20–

    –Successful financings strengthen financial position, extending cash runway into 2022–

    Millendo Therapeutics, Inc. (NASDAQ:MLND), a late-stage biopharmaceutical company primarily focused on developing novel treatments for orphan endocrine diseases, today provided a corporate update and reported financial results for the year ended December 31, 2019.

    "In 2019 we achieved critical milestones for our lead asset livoletide, including completing enrollment of the pivotal…

    –Topline results from pivotal Phase 2b study of livoletide in patients with Prader-Willi syndrome (PWS) expected in early 2Q20–

    –Topline results from first cohort of Phase 2b study of nevanimibe in patients with classic congenital adrenal hyperplasia (CAH) expected in 2H20–

    –Successful financings strengthen financial position, extending cash runway into 2022–

    Millendo Therapeutics, Inc. (NASDAQ:MLND), a late-stage biopharmaceutical company primarily focused on developing novel treatments for orphan endocrine diseases, today provided a corporate update and reported financial results for the year ended December 31, 2019.

    "In 2019 we achieved critical milestones for our lead asset livoletide, including completing enrollment of the pivotal Phase 2b ZEPHYR study in patients with PWS and building a foundation for our commercial leadership in our new office in Lexington, Massachusetts," said Julia C. Owens, President and Chief Executive Officer of Millendo Therapeutics. "In addition, we made progress on our Phase 2b study of nevanimibe for patients with CAH, where we are expecting cohort 1 topline data in the second half of 2020, and expanded our pipeline with the addition of MLE-301 for the treatment of menopausal vasomotor symptoms, with first-in-human studies expected to begin in the second half of this year.

    "The year 2020 will be an exciting one for Millendo as we continue to advance and build our pipeline of novel treatments for endocrine diseases. With an important topline data readout for livoletide from our pivotal ZEPHYR study in PWS expected in early second quarter, we look forward to building an integrated commercial organization to support future plans for what could be the first pharmacological treatment to address hyperphagia in patients with PWS."

    Fourth Quarter 2019 and Recent Highlights

    • 3-month core period of the pivotal Phase 2b study of livoletide in patients with PWS has been completed: 158 patients were randomized across 38 clinical trial sites worldwide, with an average baseline HQ-CT score of approximately 20. A total of 156 patients completed the 3-month core period with 2 subjects (~1%) discontinuing; all 156 patients have moved into the nine-month extension. The company expects to report topline data from the pivotal Phase 2b ZEPHYR study in early 2Q20. The Phase 2b study has the potential to support a New Drug Application (NDA) for livoletide.
    • Continued to advance Phase 2b clinical study of nevanimibe in patients with CAH: The Phase 2b study is ongoing with two separate cohorts of patients. Topline data from the first cohort of the study is expected in 2H20 and includes patients with elevated levels of 17-hydroxyprogesterone (17-OHP) greater than or equal to 4-times the upper limit of normal (ULN). The second cohort is continuing enrollment and includes patients with high exogenous cortisol doses and a baseline 17-OHP level of less than 4-times the ULN.
    • New pipeline asset MLE-301 expected to enter clinical trials in 2H20: MLE-301, a selective neurokinin 3 receptor (NK3R) antagonist, is intended for the treatment of vasomotor symptoms (VMS), commonly known as hot flashes and night sweats, in menopausal women. MLE-301 is currently in preclinical studies designed to enable first-in-human clinical studies, which the company expects to initiate in the second half of 2020.
    • Strengthened Company Leadership: Christophe Arbet-Engels, MD, PhD, was appointed Chief Medical Officer in February 2020, building upon the expanded Millendo leadership team including the appointments of Thomas Hoover as Chief Commercial Officer, Tamara Joseph as General Counsel and Ryan Zeidan, PhD, as Chief Development Officer. In addition, Geoff Nichol, MB, ChB, MBA, Chief Medical Officer of BioMarin, joined Millendo's board of directors.

    Anticipated 2020 Milestones

    • Report topline data from the pivotal Phase 2b study of livoletide in patients with PWS early in the second quarter of 2020.
    • Report topline data from the first cohort of the Phase 2b study of nevanimibe in patients with CAH in the second half of 2020.
    • Begin first-in-human studies of MLE-301 in the second half of 2020.

    "With an additional $34.7 million in gross proceeds from our successful financing in December 2019 as well as sales under our ATM facility, we are pleased that our current cash position is expected to support our capital needs into 2022," commented Louis J. Arcudi III, Chief Financial Officer.

    Full Year 2019 Financial Results

    Cash Position: Cash, cash equivalents, marketable securities and restricted cash were $63.5 million at December 31, 2019, compared to $78.2 million at December 31, 2018.

    Research and Development (R&D) Expenses: R&D expenses were $27.8 million for 2019, as compared to $14.4 million for the same period in 2018. The increase in R&D expenses was primarily driven by support of the company's Phase 2b clinical study of livoletide and increased headcount.

    General and Administrative (G&A) Expenses: G&A expenses were $17.6 million for 2019, as compared to $8.7 million for the same period in 2018. The increase in G&A expenses was primarily driven by increased costs related to employee compensation and professional fees to support ongoing business operations and compliance with obligations associated with being a publicly traded company.

    Net Loss: The company's net loss for the year ended December 31, 2019 was $44.6 million compared to $27.2 million for the year ended December 31, 2018.

    2020 Financial Guidance

    Millendo expects that its cash, cash equivalents, marketable securities and restricted cash will support the company's capital needs into 2022. This cash runway guidance is based on the company's current operational plans and excludes any additional funding that may be received or business development or commercialization activities that may be undertaken.

    About Livoletide

    Livoletide is an unacylated ghrelin analogue in late-stage clinical development for the treatment of hyperphagia in Prader-Willi syndrome (PWS). This rare genetic disease is characterized by hyperphagia, a chronic unrelenting hunger, that leads to obesity, metabolic dysfunction, reduced quality of life and early mortality. Livoletide may provide the first treatment for hyperphagia in patients with PWS by addressing the underlying hormone dysregulation that contributes to the disease. In a previous randomized, double-blind, placebo-controlled Phase 2a 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 hyperphagia in 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 pivotal 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 study enrolled 158 patients across 38 clinical sites in the United States, Europe and Australia. 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 study may be sufficient to support a new drug application (NDA) for livoletide.

    About Nevanimibe

    Nevanimibe decreases adrenal steroidogenesis through the inhibition of acyl coenzyme A: cholesterol acyltransferase 1, or 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. These chronic high doses of cortisol can result in side effects that include diabetes, obesity, hypertension and psychological problems. Millendo has received Orphan Drug Designation for nevanimibe for the treatment of CAH from the FDA and the EMA. In a Phase 2a 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 MLE-301

    MLE-301 is a neurokinin 3 receptor (NK3R) antagonist that is being developed as a potential treatment of VMS, commonly known as hot flashes and night sweats, in menopausal women. NK3R plays a key role in regulating the activity of KNDy (kisspeptin/NKB/dynorphin) neurons, which are believed to participate in the generation of VMS. By inhibiting the NK3R signaling on the KNDy neurons and potentially other NK3R-expressing neurons that propagate heat dissipation signals through the hypothalamus, MLE-301 aims to reduce the effects of hyperactive KNDy neurons and thereby address the excessive heat dissipation signaling associated with VMS. MLE-301 is currently in preclinical studies designed to enable first-in-human clinical studies.

    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. Millendo seeks to create distinct and transformative treatments where there is a significant unmet medical need. The company is currently advancing livoletide for the treatment of hyperphagia in 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 our plans to develop and commercialize our product candidates and the progress and timing of our ongoing and planned clinical trials for our product candidates and the sufficiency of our current capital resources, 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 without limitation, in the section entitled "Risk Factors" in our Annual Report on Form 10-K for our fiscal year ended December 31, 2019 and subsequent reports that we file with the Securities and Exchange Commission including our Annual Report on Form 10-K for the fiscal year ended December 31, 2019.

    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)
     
    Year Ended
    December 31,

     

    2019

     

     

    2018

     

    Operating Expenses
    Research and development

    $

    27,843

     

    $

    14,425

     

    General and administrative

     

    17,556

     

     

    8,691

     

    Other general expenses

     

    -

     

     

    3,758

     

    Loss from operations

     

    45,399

     

     

    26,874

     

     
    Other (income) expense, net

     

    (831

    )

     

    303

     

    Net loss

     

    (44,568

    )

     

    (27,177

    )

    Net loss attributable to noncontrolling interest

     

    -

     

     

    (15

    )

    Net loss attributable to common stockholders

    $

    (44,568

    )

    $

    (27,192

    )

    Net loss per share of common stock, basic and diluted

    $

    (3.25

    )

    $

    (17.58

    )

    Weighted-average shares of common stock outstanding, basic and diluted

     

    13,706,744

     

     

    1,547,051

     

     
     
    Millendo Therapeutics, Inc.
    Condensed Balance Sheet Data
    (in thousands)
     
    December 31, December 31,

     

    2019

     

     

    2018

     

    Cash, cash equivalents, marketable securities and restricted cash

    $

    63,512

     

    $

    78,155

     

    Other assets

     

    11,458

     

     

    5,919

     

    Total assets

    $

    74,970

     

    $

    84,074

     

     
    Total liabilities

    $

    15,099

     

    $

    10,952

     

    Total stockholders' equity

     

    59,871

     

     

    73,122

     

    Total liabilities and stockholders' equity

    $

    74,970

     

    $

    84,074

     

     

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  4. Millendo Therapeutics, Inc. (NASDAQ:MLND), a late-stage biopharmaceutical company primarily focused on developing novel treatments for orphan endocrine diseases, announced today that Julia C. Owens, Ph.D., President and Chief Executive Officer, and company management will participate in the following healthcare investor conferences:

    32nd Annual ROTH Conference

    Panel Presentation

    Date and Time: March 16, 2020 at 12:00 p.m. PST

    Location: Dana Point, CA

    Oppenheimer & Co. 30th Annual Healthcare Conference

    Corporate Presentation

    Date and Time: March 18, 2020 at 2:45 p.m. EST

    Location: New York, NY

    A live webcast of the Oppenheimer presentation will be available on the Investors & Media section of Millendo's website at http://investors.millendo.com

    Millendo Therapeutics, Inc. (NASDAQ:MLND), a late-stage biopharmaceutical company primarily focused on developing novel treatments for orphan endocrine diseases, announced today that Julia C. Owens, Ph.D., President and Chief Executive Officer, and company management will participate in the following healthcare investor conferences:

    32nd Annual ROTH Conference

    Panel Presentation

    Date and Time: March 16, 2020 at 12:00 p.m. PST

    Location: Dana Point, CA

    Oppenheimer & Co. 30th Annual Healthcare Conference

    Corporate Presentation

    Date and Time: March 18, 2020 at 2:45 p.m. EST

    Location: New York, NY

    A live webcast of the Oppenheimer 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 seeks to create 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 Full Article Hide Full Article
  5. Millendo Therapeutics, Inc. (NASDAQ:MLND), a late-stage biopharmaceutical company primarily focused on developing novel treatments for orphan endocrine diseases, announced today that Julia C. Owens, Ph.D., President and Chief Executive Officer, will present at the 9th Annual SVB Leerink Global Healthcare Conference in New York City on Wednesday, February 26, 2020 at 2:00 p.m. EST.

    A live webcast of the 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…

    Millendo Therapeutics, Inc. (NASDAQ:MLND), a late-stage biopharmaceutical company primarily focused on developing novel treatments for orphan endocrine diseases, announced today that Julia C. Owens, Ph.D., President and Chief Executive Officer, will present at the 9th Annual SVB Leerink Global Healthcare Conference in New York City on Wednesday, February 26, 2020 at 2:00 p.m. EST.

    A live webcast of the 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 seeks to create 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 Full Article Hide Full Article
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