Lumos Pharma Reports Full Year 2022 Financial Results, Provides Clinical Development Updates
-- Patient Enrollment Completed in OraGrowtH210 and OraGrowtH212 Trials --
-- Primary Outcome Data for both OraGrowtH Trials Expected Q4 2023 --
-- Additional Data from OraGrowtH Trials to be Presented at IMPE 2023 --
-- Conference Call Scheduled for Today at
“We are pleased with the progress we made in 2022 advancing two Phase 2 OraGrowtH Trials evaluating our oral therapeutic candidate, LUM-201, in idiopathic PGHD,” said
- Patient Enrollment Completed in Two Phase 2 OraGrowtH Trials Evaluating Oral LUM-201 in Idiopathic (moderate) PGHD. The last subjects have been randomized in our OraGrowtH210 and OraGrowtH212 Trials, and we now expect primary outcome data on 82 subjects in the OraGrowtH210 Trial and 22 subjects in the PK/PD OraGrowtH212 Trial in the fourth quarter of 2023.
- Interim analyses for Phase 2 OraGrowtH210 and PK/PD OraGrowtH212 Trials announced
November 2022. Data from the interim analysis of our OraGrowtH210 Trial showed LUM-201 met growth expectations, showed durable response and was well-tolerated. Data support the selection of 1.6 mg/kg/day as the optimal dose for our pivotal Phase 3 trial. The control arm for this interim analysis included outliers with growth greater than prior data precedents, the impact of which we expect to diminish with full enrollment. Interim data from our OraGrowtH212 Trial were supportive of the OraGrowtH210 Trial data.
- Key Opinion Leaders encouraged by interim OraGrowtH Trials data. We hosted a webinar featuring Drs.
Andrew Dauberand Fernando Cassorla, distinguished opinion leaders in the field of pediatric endocrinology, for a discussion of the interim data from our Phase 2 OraGrowtH210 and PK/PD OraGrowtH212 Trials. A replay of the event is available in the “Events & Presentations” section under “Investors & Media” on our website.
- Pilot Investigator-Initiated Trial evaluating LUM-201 in NAFLD supported by prior data. As previously announced, we entered into a clinical collaboration with Dr.
Laura Dichteland Massachusetts General Hospitalto explore the potential of LUM-201 in Nonalcoholic Fatty Liver Disease (NAFLD) in an investigator sponsored pilot study. Encouraging data presented by Dr. Dichtelat ENDO 2022 (abstract) evaluating injectable growth hormone in NAFLD supported the assessment of oral LUM-201 in the same indication. Enrollment in the trial is ongoing.
- Additional Data on LUM-201 OraGrowtH Trials to be presented in an oral and a poster presentation at the 2023 International Meeting of Pediatric Endocrinology (IMPE) in
Buenos Aires, Argentina March 4-7, 2023. We are pleased to have two abstracts accepted for presentation at the upcoming IMPE meeting. Details are as follows:
- Oral Presentation - Dose-dependent Increase in GH AUC0-12h with LUM-201 in Idiopathic Pediatric GH Deficiency (iPGHD) from the Interim Analysis Data of the OraGrowtH212 Trial
- Poster Presentation - Baseline Demographics of the OraGrowtH210 Trial Studying LUM-201 in Idiopathic Pediatric Growth Hormone Deficiency (iPGHD) Interim Analysis Data
- Formulation patent for LUM-201 filed
November 2022. In November 2022, we filed a patent application PCT/US22/050700 titled “Compactable Oral Formulations of Ibutamoren.” The application is currently pending and contains claims directed to certain improved formulations we intend to utilize in our Phase 3 trial and ultimately commercialize. If granted, this patent would provide composition of matter protection through November 2042for the commercialized version of LUM-201.
Financial Results for the Year Ended
- Cash Position –
Lumos Pharmaended the year on December 31, 2022, with cash, cash equivalents, and short-term investments totaling $67.4 million compared to $94.8 million on December 31, 2021. The Company expects an average cash use of approximately $9.5to $10.5 millionper quarter through 2023. Cash on hand as of December 31, 2022is expected to support operations into the third quarter of 2024.
- R&D Expenses – Research and development expenses were
$17.9 million, an increase of $1.6 million for the year ended December 31, 2022compared to the same period in 2021, primarily due to increases of $1.1 millionin clinical trial and contract manufacturing expenses, $0.5 millionin consulting expenses and $0.3 millionin personnel-related expenses, offset by decreases of $0.2 millionin stock compensation expenses and $0.1 millionin operating expenses for supplies, depreciation and rent.
- G&A Expenses – General and administrative expenses were
$15.7 million, an increase of $0.4 million for the year ended December 31, 2022compared to the same period in 2021, primarily due to increases of $0.9 millionin royalty expenses, $0.4 millionin travel expense and $0.3 millionin other expenses, offset by decreases of $0.4 millionin personnel-related expenses, $0.4 millionin stock compensation expenses, $0.3 millionin consulting expenses and $0.1 millionin operating expenses for supplies, depreciation and rent.
- Net Loss – The net loss for the year ended
December 31, 2022, was $31.1 million compared to a net loss of $30.4 millionfor the same period in 2021. Lumos Pharmaended Q4 2022 with 8,267,968 shares outstanding.
About Lumos Pharma’s Clinical Trials
Phase 2 OraGrowtH210 Trial of Oral LUM-201 in PGHD
The OraGrowtH210 Trial is a multi-site, global trial evaluating orally administered LUM-201 at three dose levels (0.8, 1.6, 3.2 mg/kg/day) against a standard dose of injectable rhGH in approximately 80 subjects diagnosed with idiopathic (moderate) PGHD, which is less severe than organic PGHD. The objective of this trial is to identify the optimal dose of LUM-201 to be used in a Phase 3 registration trial, based on annualized height velocity from a 6-month dataset, and to prospectively confirm the preliminary validation of our Predictive Enrichment Marker (PEM) strategy. The complete set of 6-month, primary outcome data for 82 subjects is anticipated in the fourth quarter of 2023. Subjects will be dosed for a total of 24 months.
OraGrowtH212 Trial Evaluating PK/PD and Pulsatility of Oral LUM-201 in PGHD
The OraGrowtH212 Trial is a single site, open-label trial evaluating the pharmacokinetic (PK) and pharmacodynamic (PD) effects of oral LUM-201 in up to 24 PGHD subjects at two dose levels, 1.6 and 3.2 mg/kg/day. The primary objective of the OraGrowtH212 Trial is to confirm prior clinical data demonstrating the amplified pulsatile release of endogenous growth hormone from LUM-201 therapy, contributes to its efficacy in PGHD. The primary endpoint for this trial is 6 months of PK/PD (pulsatility) and height velocity data in the randomized subjects. Subjects will be allowed to remain on treatment until they reach a bone age of 14 for females and 16 for males reflecting near-adult height. Primary data readout in 22 subjects is anticipated in the fourth quarter of 2023.
Switch Study, OraGrowtH213 Trial, Evaluating LUM-201 in OraGrowtH210 Subjects Previously on rhGH
The OraGrowtH213 Trial is an open-label, multi-center, Phase 2 study evaluating the growth effects and safety of LUM-201 following 12 months of daily rhGH in up to 20 idiopathic PGHD patients who have completed the OraGrowtH210 Trial. Subjects will be administered LUM-201 at a dose level of 3.2 mg/kg/day for up to 12 months.
Lumos Pharma Collaboration with Massachusetts General Hospital Evaluating LUM-201 in NAFLD
Conference Call and Webcast Details
The Company has scheduled a conference call and webcast for
Investors and the general public are invited to listen to the conference call. To access the call by phone, please click on this Registration Link, complete the form and you will be provided with dial-in details and a PIN. To avoid delays, we encourage participants to dial in to the conference call ten minutes ahead of the scheduled start time. The webcast may be accessed through this Webcast Link and may also be found in the “Investors & Media” section of the
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements of
We are passionate about our business - including LUM-201 and the potential it may have to help patients in the clinic. This passion feeds our optimism that our efforts will be successful and bring about meaningful change for patients. Please keep in mind that actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements that we make.
We have attempted to identify forward-looking statements by using words such as “projected,” "upcoming," "will," “would,” "plan," “intend,” "anticipate," "approximate," "expect," “potential,” “imminent,” and similar references to future periods or the negative of these terms. Not all forward-looking statements contain these identifying words. Examples of forward-looking statements include, among others, statements we make regarding the encouraging growth response in our LUM-201 trials, progress in our clinical efforts including the timing of expected results on our trials and our ability to continue advancing our trials, 1.6 mg/kg/day as the optimal dose for our Pivotal Phase 3 trial, that the control arm for this interim analysis included outliers with growth greater than prior data precedents and that the impact of which we expect to diminish with full enrollment, encouraging data presented by
We wish we were able to predict the future with 100% accuracy, but that just is not possible. Our forward-looking statements are neither historical facts nor assurances of future performance. You should not rely on any of these forward-looking statements and, to help you make your own risk determinations, we have provided an extensive discussion of risks that could cause actual results to differ materially from our forward-looking statements including risks related to the final results of our LUM-201 Trials being different than our interim results, the effects of pandemics, other widespread health problems or military conflicts including the
We anticipate that subsequent events and developments will cause our views to change. We may choose to update these forward-looking statements at some point in the future, however, we disclaim any obligation to do so. As a result, you should not rely on these forward-looking statements as representing our views as of any date subsequent to the date of this press release.
Investor & Media Contact:
Lumos Pharma Investor Relations
|Consolidated Statements of Operations and Comprehensive Loss|
|(In thousands, except share and per share amounts)
|Licensing and collaboration revenue||$||—||$||10|
|Research and development||17,857||16,246|
|General and administrative||15,706||15,331|
|Total operating expenses||33,563||31,577|
|Loss from operations||(32,040||)||(31,347||)|
|Other income and expense:|
|Other income, net||91||269|
|Other income, net||965||281|
|Net loss before taxes||(31,075||)||(31,066||)|
|Income tax benefit||13||636|
|Net loss per share of common stock|
|Basic and diluted||$||(3.71||)||$||(3.65||)|
|Weighted average number of common shares outstanding|
|Basic and diluted||8,373,821||8,334,516|
|Other comprehensive loss|
|Unrealized loss on short-term investments||$||(9||)||$||—|
|Total comprehensive loss||$||(31,071||)||$||(30,430||)|
|Consolidated Balance Sheets|
|(In thousands, except share and per share amounts)
|Cash and cash equivalents||$||56,007||$||94,809|
|Prepaid expenses and other current assets||4,427||4,740|
|Total current assets||72,009||99,677|
|Property and equipment, net||53||79|
|Total non-current assets||283||635|
|Liabilities and Stockholders' Equity|
|Current portion of lease liability||233||352|
|Total current liabilities||6,708||5,130|
|Royalty obligation payable to
|Total long-term liabilities||6,000||6,205|
|Commitments and contingencies:|
|Undesignated preferred stock,
|Additional paid-in capital||187,164||185,429|
|Accumulated other comprehensive loss||(9||)||—|
|Total stockholders' equity||59,584||88,977|
|Total liabilities and stockholders' equity||$||72,292||$||100,312|
Source: Lumos Pharma, Inc.