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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
Date of report (Date of earliest event reported): June 11, 2025
HARMONY BIOSCIENCES HOLDINGS, INC.
(Exact name of registrant as specified in its charter)
Delaware |
001-39450 |
82-2279923 |
(State or other jurisdiction |
(Commission |
(IRS Employer |
of incorporation) |
File Number) |
Identification No.) |
630 W. Germantown Pike, Suite 215
Plymouth Meeting, PA 19462
(Address of principal executive offices) (Zip Code)
(484) 539-9800
(Registrant’s telephone number, including area code)
N/A
(Former name or former address, if changed since last report.)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
☐ |
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
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Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
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Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities registered pursuant to Section 12(b) of the Act:
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Trading |
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Name of each exchange |
Title of each class |
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Symbol(s) |
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on which registered |
Common Stock, $0.00001 par value per share |
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HRMY |
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The Nasdaq Global Market |
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company ☐
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Item 7.01. Regulation FD Disclosure.
On June 11, 2025, Harmony Biosciences Holdings, Inc. (the Company) issued a press release announcing the Company’s new preclinical pharmacological effect data for BP1.15205, an investigational, highly potent, and potentially best-in-class orexin 2 receptor (OX2R) agonist, which demonstrated significant wake-promoting and cataplexy-suppressing effects in a standard transgenic mouse model of narcolepsy type 1. The full text of the press release in connection with this announcement is being furnished as Exhibit 99.1 to this Current Report on Form 8-K.
Additionally, on June 11, 2025, the Company will present this new preclinical pharmacological effect data for BP1.15205 in a presentation during the 39th Annual Meeting of the Associated Professional Sleep Societies.
The Company also announced that an Investigational Medicinal Product Dossier application with the European Medicines Agency is being completed for BP1.15205. A first-in-human study is planned to begin in the second half of 2025 with topline data anticipated in 2026. Additionally, an Investigational New Drug application for BP1.15205 will be filed with the U.S. Food and Drug Administration.
The information contained in Item 7.01 of this Current Report (including Exhibit 99.1 attached hereto) shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly provided by specific reference in such a filing.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits.
Exhibit |
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No. |
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Description |
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99.1* |
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104 |
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Cover Page Interactive Data File (embedded within the Inline XBRL document). |
* |
This Exhibit is furnished herewith and will not be deemed “filed” for purposes of Section 18 of the Exchange Act or deemed to be incorporated by reference into any filing under the Exchange Act or the Securities Act except to the extent that Harmony Biosciences Holdings, Inc. specifically incorporates it by reference. |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
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HARMONY BIOSCIENCES HOLDINGS, INC. |
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Date: June 11, 2025 |
By: |
/s/ Christian Ulrich |
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Christian Ulrich |
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SVP and General Counsel |
Harmony Biosciences Presents Preclinical Data Demonstrating Significant Wake-Promoting and Cataplexy-Suppressing Effects of BP1.15205 in Narcolepsy at SLEEP 2025
BP1.15205 is a potentially best-in-class OX2R agonist being investigated in narcolepsy and other central disorders of hypersomnolence
A first-in-human study is planned to start in 2H 2025; topline clinical data is anticipated in 2026
PLYMOUTH MEETING, Pa., June 11, 2025 /Business Wire/ -- Harmony Biosciences Holdings, Inc. (Nasdaq: HRMY) today announced the presentation of preclinical pharmacological effect data for BP1.15205, an investigational, highly potent, and potentially best-in-class orexin 2 receptor (OX2R) agonist, which demonstrated significant wake-promoting and cataplexy-suppressing effects in a standard transgenic mouse model of narcolepsy type 1. The data will be presented at the 39th Annual Meeting of the Associated Professional Sleep Societies (APSS) “SLEEP” on Wednesday, June 11, 2025, at 10:00 AM PDT in Seattle.
“We are encouraged by the robust preclinical data being presented at SLEEP, highlighting BP1.15205 as a potentially best-in-class OX2R agonist,” said Kumar Budur, MD, MS, Chief Medical and Scientific Officer at Harmony Biosciences. “BP1.15205 is a new and unique chemical scaffold optimized for high potency that demonstrated statistically significant wake-promoting effects at very low doses administered orally in the standard transgenic mouse model. These findings are supportive of dosing flexibility to potentially treat all three central disorders of hypersomnolence at low doses, which could offer an optimized benefit / risk profile. The 3-month GLP toxicity study in two species revealed no concerning adverse events and supports a favorable safety and tolerability profile.”
An Investigational Medicinal Product Dossier (IMPD) application with the European Medicines Agency (EMA) is being completed for BP1.15205. A first-in-human study is planned to begin in 2H 2025 with topline data anticipated in 2026. Additionally, an Investigational New Drug (IND) application for BP1.15205 will be filed with the U.S. Food and Drug Administration (FDA).
“We are very excited to advance our potentially best-in-class OX2R program and support the strategic expansion of our sleep-wake franchise. We are dedicated to investigating this potential new solution further with the hope of bringing a novel treatment to market that can help even more people with narcolepsy and other central disorders of hypersomnolence,” Budur added.
The poster entitled, “BP1.15205, a Novel Orexin-2 Receptor Agonist, Demonstrates Pharmacological Effects in a Mouse Model of Narcolepsy,” will be presented at P-38; Poster Board Number 1; on June 11, 2025, at 10:00 AM PDT.
KEY FINDINGS FROM THE STUDIES INCLUDE:
In Vitro Orexin Receptor Functional Studies:
| ● | BP1.15205 is a highly potent agonist at OX2R receptors: EC50 = 0.015 nM. |
| ● | BP1.15205 is highly selective for human OX2R receptors: >600-fold selectivity over human OX1R receptors. |
| ● | Minimal interspecies difference in agonist functional properties was observed between human and mouse orexin-2 receptors. |
In Vivo Pharmacology Studies:
| ● | Single oral dose administration of BP1.15205 in transgenic mice at the beginning of the 12-hour dark period of a 24-hour light/dark cycle produced significant and dose-dependent increases in total wakefulness time and sleep latency at every dose tested beginning at 0.03 and 0.1 mg/kg, respectfully, as compared to vehicle-treated animals. |
| ● | Significant and dose-dependent decreases in the total number and duration of cataplexy-like episodes were measured following single dose, oral administration |
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| of BP1.15205 beginning at 1mg/kg, as compared to vehicle. |
About Narcolepsy
Narcolepsy is a rare, chronic, debilitating neurological disease of sleep-wake state instability that impacts approximately 170,000 Americans and is primarily characterized by excessive daytime sleepiness (EDS) and cataplexy – its two cardinal symptoms – along with other manifestations of REM sleep dysregulation (hallucinations and sleep paralysis), which intrude into wakefulness. EDS is the inability to stay awake and alert during the day and is the symptom that is present in all people living with narcolepsy. In most patients, narcolepsy is caused by the loss of hypocretin/orexin, a neuropeptide in the brain that supports sleep-wake state stability. This disease affects men and women equally, with typical symptom onset in adolescence or young adulthood; however, it can take up to a decade to be properly diagnosed.
About Harmony Biosciences
Harmony Biosciences is a pharmaceutical company dedicated to developing and commercializing innovative therapies for patients with rare neurological diseases who have unmet medical needs. Driven by novel science, visionary thinking, and a commitment to those who feel overlooked, Harmony Biosciences is nurturing a future full of therapeutic possibilities that may enable patients with rare neurological diseases to truly thrive. Established by Paragon Biosciences, LLC, in 2017 and headquartered in Plymouth Meeting, Pa., we believe that when empathy and innovation meet, a better future can begin; a vision evident in the therapeutic innovations we advance, the culture we cultivate, and the community programs we foster. For more information, please visit www.harmonybiosciences.com.
Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including statements regarding our full year 2025 net product revenue, expectations for the growth and value of WAKIX, plans to submit an sNDA for pitolisant in idiopathic hypersomnia; our future results of operations and financial position, business strategy, products, prospective products, product approvals, the plans and objectives of management for future operations and future results of anticipated products.
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These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, the following: our commercialization efforts and strategy for WAKIX; the rate and degree of market acceptance and clinical utility of pitolisant in additional indications, if approved, and any other product candidates we may develop or acquire, if approved, including ZYN002 and EPX-100; our research and development plans, including our plans to explore the therapeutic potential of pitolisant in additional indications; our ongoing and planned clinical trials; our ability to expand the scope of our license agreements with Bioprojet Société Civile de Recherche (“Bioprojet”); the availability of favorable insurance coverage and reimbursement for WAKIX; the timing of, and our ability to obtain, regulatory approvals for pitolisant for other indications as well as any other product candidates; our estimates regarding expenses, future revenue, capital requirements and additional financing needs; our ability to identify, acquire and integrate additional products or product candidates with significant commercial potential that are consistent with our commercial objectives; our commercialization, marketing and manufacturing capabilities and strategy; significant competition in our industry; our intellectual property position; loss or retirement of key members of management; failure to successfully execute our growth strategy, including any delays in our planned future growth; our failure to maintain effective internal controls; the impact of government laws and regulations; volatility and fluctuations in the price of our common stock; the significant costs and required management time as a result of operating as a public company; the fact that the price of Harmony's common stock may be volatile and fluctuate substantially; statements related to our intended share repurchases and repurchase timeframe; and macroeconomic effects and changes in market conditions, including the impact of tariffs, inflation and the risk of recession. These and other important factors discussed under the caption "Risk Factors" in our Annual Report on Form 10-K filed with the Securities and Exchange Commission (the "SEC") on February 25, 2025, and our other filings with the SEC could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management's estimates as of the date of this press release. While we may elect to update such forward-looking statements at some point in the future, we disclaim any obligation to do so, even if subsequent events cause our views to change.
Harmony Biosciences Investor Contact:
Brennan Doyle
484-539-9700
bdoyle@harmonybiosciences.com
Harmony Biosciences Media Contact:
Cate McCanless
202-641-6086
cmccanless@harmonybiosciences.com
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