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): April 27, 2021
| LUMOS PHARMA, INC. | ||||||||
| (Exact name of registrant as specified in its charter) | ||||||||
| Delaware | 001-35342 | 42-1491350 | ||||||
| (State or other jurisdiction | (Commission | (IRS Employer | ||||||
| of incorporation) | File Number) | Identification No.) | ||||||
| 4200 Marathon Blvd., Suite 200 Austin, TX | 78756 | |||||||
| (Address of principal executive offices) | (Zip Code) | |||||||
Registrant's telephone number, including area code: (512) 215-2630 | ||||||||
| (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 (see General Instruction A.2. below):
[ ] Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
[ ] Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
[ ] Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
[ ] 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:
| Title of each class | Trading Symbol(s) | Name of each exchange on which registered | ||||||
| Common Stock | LUMO | The Nasdaq Stock 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). ☐
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 ☐
Section 8 - Other Events
Item 8.01. Other Events.
On April 27, 2021, Lumos Pharma, Inc. issued a press release titled “Newly Released Data on Three PGHD Patients Treated with LUM-201 in Prior Phase 2 Study To Be Presented in Lumos Pharma Key Opinion Leader Webinar.”
A copy of the press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference.
Section 9 - Financial Statements and Exhibits
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits.
| Exhibit Number | Description | |||||||
| 99.1 | Press Release, dated April 27, 2021, entitled “Newly Released Data on Three PGHD Patients Treated with LUM-201 in Prior Phase 2 Study To Be Presented in Lumos Pharma Key Opinion Leader Webinar” | |||||||
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.
Dated: April 27, 2021
| LUMOS PHARMA, INC., a Delaware corporation | |||||
| By: | /s/ Richard J. Hawkins | ||||
| Richard J. Hawkins | |||||
| Its: | Chief Executive Officer | ||||
Exhibit 99.1
FOR IMMEDIATE RELEASE
Newly Released Data on Three PGHD Patients Treated with LUM-201 in Prior Phase 2 Study To Be Presented in Lumos Pharma Key Opinion Leader Webinar
Virtual KOL Event is scheduled for Today, April 27th @ 10:30 AM ET
AUSTIN, TX, April 27, 2021 (GLOBE NEWSWIRE) – Lumos Pharma, Inc. (NASDAQ:LUMO), a clinical-stage biopharmaceutical company focused on therapeutics for rare diseases, today announced that new data highlights from three patients with pediatric growth hormone deficiency (PGHD) previously treated with the company’s lead asset LUM-201 will be presented during a virtual key opinion leader (KOL) event to be held today, April 27, 2021, at 10:30am ET.
The webinar will feature presentations by KOLs Bradley S. Miller, M.D., Ph.D., University of Minnesota, and Fernando Cassorla, M.D., University of Chile, who will discuss the current treatment and unmet medical need in PGHD. Drs. Miller and Cassorla will be available to answer questions following the formal presentations. In today’s webinar, the Lumos management team will also give a corporate update and discuss their leading pipeline candidate LUM-201 in PGHD.
This never previously released data from Merck’s 020 study will be presented by Dr. Cassorla as part of his overview of the key aspects of LUM-201’s mechanism of action. This subgroup of the Merck 020 trial specifically examined the effect LUM-201 had on the pulsatile secretion of growth hormone (GH) over 24 hours in patients with PGHD after 6 months of treatment with LUM-201, compared to that patient’s baseline GH secretion. As has been previously disclosed in adults, LUM-201 increased the pulsatile release of growth hormone for 24 hours in Predictive Enrichment Marker (PEM) Positive subjects (N=2). GH area under the curve (AUC) increases of less than 2-fold in these PEM-Positive subjects resulted in sizable increases in height velocity after 6 months of treatment. The importance of PEM selection is demonstrated with one PEM-Negative subject showing no increase in GH AUC over the 24-hour monitoring period nor an increase in height velocity after 6 months of treatment with LUM-201. These data support the mechanism of action of LUM-201, augmented pulsatile release of GH, and further support the use of PEMs to identify patients likely to respond to LUM-201. These results are also consistent with data published recently in the Journal of the Endocrine Society (JES) and presented at the Endocrine Society 2021 Annual Meeting.
To register for the webinar, please click here.
Investors and the general public are invited to listen to a live audio webcast of the conference call, which may be accessed five minutes prior to the start of the call by dialing (855) 469-0612 (U.S.) or (484) 756-4268 (international) or through the link, https://edge.media-server.com/mmc/p/dvreqx64. The link to the live webcast may also be found in the “Investors & Media” section of the Lumos Pharma website, under “Events & Presentations.” A replay of the call will be available for two weeks from the date of the call and may be accessed through the same link above or by dialing (855) 859-2056 (U.S.) or (404) 537-3406 (international) and using the passcode: 5863619.
About Pediatric Growth Hormone Deficiency and LUM-201
Growth hormone (GH) deficiency is the consequence of inadequate secretion of growth hormone from the pituitary gland that results in low GH in the body, insufficient production of downstream signaling molecules required for growth, and the subsequent lack of growth. In children, this rare disorder is called pediatric growth hormone deficiency (PGHD). LUM-201, also known as ibutamoren, is an orally administered small molecule that promotes the secretion of GH from the pituitary gland and represents an opportunity for appropriately selected patients to avoid the daily or weekly injections involved with current or forthcoming therapies. LUM-201 has been observed to increase the amplitude of endogenous pulsatile GH secretion, which mimics the natural pattern of GH secretion.
Exhibit 99.1
About Lumos Pharma
Lumos Pharma, Inc. is a clinical-stage biopharmaceutical company focused on the development and commercialization of therapeutics for rare diseases. Lumos Pharma was founded and is led by a management team with longstanding experience in rare disease drug development and received early funding by leading healthcare investors, including Deerfield Management, a fund managed by Blackstone Life Sciences, Roche Venture Fund, New Enterprise Associates (NEA), Santé Ventures, and UCB. Lumos Pharma’s lead therapeutic candidate is LUM-201, an oral growth hormone stimulating small molecule, currently being evaluated in a Phase 2b clinical trial, the OraGrowtH210 Trial, for the treatment of Pediatric Growth Hormone Deficiency (PGHD). If approved by the FDA, LUM-201 would provide an orally administered alternative to daily injections that current PGHD patients endure for many years of treatment. LUM-201 has received Orphan Drug Designation in both the US and EU. For more information, please visit www.lumos-pharma.com.
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Investor & Media Contact:
Lisa Miller
Lumos Pharma Investor Relations
512-792-5454
ir@lumos-pharma.com
Corey Davis, PhD
LifeSci Advisors
cdavis@lifesciadvisors.com
LifeSci Advisors
cdavis@lifesciadvisors.com
.