Lumos Pharma Reports First Quarter 2022 Financial Results and Clinical Development Updates
--Phase 2 OraGrowtH210 Trial Reached 50% Randomization Milestone – Interim Data from Phase 2 and PK/PD OraGrowtH Trials Anticipated by End of 2022--
--FDA Permits Treatment with LUM-201 Beyond 12 Months and Lifts Partial Clinical Hold--
--Clinical Collaboration Initiated with
“To date, 2022 has been a productive period for Lumos, with encouraging enrollment trends in both of our OraGrowtH210 and OraGrowtH212 trials evaluating orally administered LUM-201 in pediatric growth hormone disease (PGHD) and our announcement of planned interim data analyses by the end of this year,” said
- Phase 2 OraGrowtH210 Trial exceeds 50% randomization – Interim analyses for OraGrowtH210 and PK/PD OraGrowtH212 Trials by end of 2022. OraGrowtH210 has now exceeded the 50% randomization milestone, and subject enrollment in both the OraGrowtH210 and OraGrowtH212 Trials is progressing sufficiently for us to confirm our plan to conduct interim analyses of data from both trials by the end of 2022. We believe the interim data should provide an early indication of efficacy and safety of oral LUM-201 versus standard of care daily rhGH injections in PGHD. We continue to anticipate primary outcome data on 80 subjects from our OraGrowtH210 Trial in the second half of 2023.
- FDA lifts partial clinical hold on treatment beyond 12 months after review of preliminary data from OraGrowtH trials. In
July 2021, we announced that the U.S. Food & Drug Administration(FDA) had restricted treatment with LUM-201 to no more than 12 months. Based on a review of preliminary safety and efficacy data from both OraGrowtH trials in progress the FDA has lifted the partial hold and will now permit treatment with LUM-201 beyond twelve months. As a result, the OraGrowtH210 Trial will be extended to 24 months to allow subjects to continue LUM-201 therapy uninterrupted. Additionally, we plan to extend the duration of the OraGrowtH212 Trial.
- Peer-reviewed journal publication demonstrates LUM-201’s potency as GH secretagogue. A peer-reviewed article illustrating LUM-201’s greater potency over standard growth hormone secretagogues was published
March 30, 2022, in the journal, Hormone Researchin Paediatrics. The article, co-authored by George Bright, MD and Michael Thorner, MB, BS, entitled “A GH Secretagogue Receptor Agonist (LUM-201) Elicits Greater GH Responses than Standard GH Secretagogues in Subjects of a Pediatric GH Deficiency Trial,” further supports prior data suggesting LUM-201’s therapeutic potential when administered to pediatric subjects with idiopathic growth hormone deficiency. Lumos Pharmacollaborates with Massachusetts General to evaluate LUM-201 in NAFLD. The Company 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-initiated pilot study. While we remain focused on our core LUM-201 program in PGHD, the Company is pleased to support Mass General’s exploration of LUM-201’s potential in this indication, a condition estimated to be prevalent in approximately 25% of adults worldwide. NAFLD can often advance to the more serious liver disease non-alcoholic steatohepatitis ( NASH) with fibrosis, and NASH-associated liver failure is one of the leading causes of liver transplants in the United States.
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 interim analysis will evaluate the safety and annualized height velocity of the three dose levels of LUM-201 against a standard dose of injectable recombinant human growth hormone (rhGH) in a minimum of 40 subjects at six months on therapy. The complete set of 6-month, primary outcome data for 80 patients is anticipated in the second half 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 objective of the OraGrowtH212 Trial is to confirm prior clinical data demonstrating the amplified pulsatile release of endogenous growth hormone from LUM-201 therapy differentially contributes to its efficacy in PGHD. The primary endpoint for this trial is six months of PK/PD and height velocity data in up to 24 subjects. Subjects will be dosed for a total of 12 months, with a plan to extend the duration of the trial. Interim data on a minimum of 10 subjects is anticipated by the end of 2022.
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
Financial Results for the Quarter Ended
- Cash Position –
Lumos Pharmaended the quarter on March 31, 2022with cash and cash equivalents totaling $86.8 millioncompared to $94.8 millionon December 31, 2021. The Company expects an average cash use of approximately $8.5to $9.5 millionper quarter through 2022. Cash on hand as of March 31, 2022is expected to support operations through the primary outcome data readout from the OraGrowtH210 Trial anticipated in the second half of 2023 and the OraGrowtH212 Trial.
- R&D Expenses – Research and development expenses were
$4.2 million for the quarter ended March 31, 2022, a decrease compared to $4.7 millionfor the same period in 2021, primarily due to decreases of $0.5 millionin personnel-related expenses, $0.3 millionin stock compensation expenses and $0.1 millionin legal and consulting expenses, offset by an increase of $0.5 millionin clinical trial and contract manufacturing expenses.
- G&A Expenses – General and administrative expenses were
$3.6 millionfor the quarter ended March 31, 2022, a decrease compared to $4.0 millionfor the same period in 2021, primarily due to decreases of $0.3 millionin legal and consulting expenses, $0.2 millionin stock compensation expenses, and $0.1 millionin depreciation expenses, offset by increases of $0.1 millionin licensing expenses and $0.2 millionin other expenses.
- Net Loss – The net loss for the quarter ended
March 31, 2022was $7.7 millioncompared to net loss of $8.6 millionfor the same period in 2021. Lumos Pharmaended the first quarter 2022 with 8,358,625 shares outstanding.
Conference Call and Webcast Details
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Access to the live conference call is available five minutes prior to the start of the call by dialing (855) 469-0612 (
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 progress in our clinical efforts including comments concerning screening and enrollment for our trials, momentum building in our LUM-201 program for PGHD, anticipated timing of interim analyses of trials, our belief that the interim data should provide an early indication of efficacy and safety of oral LUM-201 versus standard of care daily rhGH injections in PGHD, LUM-201's therapeutic potential when administered to pediatric subjects with idiopathic growth hormone deficiency, expecting the primary outcome data readout for our trials, the potential to expand our LUM-201 platform into other indications, anticipated market reception to our treatment regimen for PGHD and other indications, plans related to initiation and execution of clinical trials; plans related to moving additional indications into clinical development; future financial performance, results of operations, cash position, cash use rate and sufficiency of capital resources to fund our operating requirements through the primary outcome data readout from the OraGrowtH210 and OraGrowtH212 Trials, and any other statements other than statements of historical fact.
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 in the "Risk Factors" section and elsewhere in Lumos Pharma’s Annual Report on Form 10-K for the year ended
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.
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|Condensed Consolidated Statements of Operations|
|(In thousands, except share and per share amounts)
|Three Months Ended
|Research and development||4,221||4,660|
|General and administrative||3,621||3,957|
|Total operating expenses||7,842||8,617|
|Loss from operations||(7,731||)||(8,617||)|
|Other income and expense:|
|Other income, net||6||20|
|Other (expense) income, net||11||(14||)|
|Net loss per share:|
|Basic and diluted||$||(0.92||)||$||(1.04||)|
|Weighted average number of common shares outstanding:|
|Basic and diluted||8,357,969||8,316,888|
|Condensed Consolidated Balance Sheets|
|(In thousands, except share and per share amounts)
|Cash and cash equivalents||$||86,758||$||94,809|
|Prepaid expenses and other current assets||5,753||4,740|
|Income tax receivable||134||128|
|Total current assets||92,645||99,677|
|Property and equipment, net||69||79|
|Total non-current assets||545||635|
|Liabilities and Stockholders' Equity|
|Current portion of lease liability||345||352|
|Total current liabilities||5,242||5,130|
|Royalty obligation payable to
|Total long-term liabilities||6,131||6,205|
|Commitments and contingencies:|
|Undesignated preferred stock,
|Additional paid-in capital||$||185,994||$||185,429|
|Total stockholders' equity||81,817||88,977|
|Total liabilities and stockholders' equity||$||93,190||$||100,312|
Source: Lumos Pharma, Inc.