Lumos Pharma Reports Full Year 2021 Financial Results and Announces Plan to Perform Interim Analyses of OraGrowtH Trials
“We are excited to announce that we plan to conduct interim analyses on two of our OraGrowtH Trials evaluating orally administered LUM-201 in PGHD,” commented
Clinical and Business Updates
- Phase 2 OraGrowtH210 Trial of Oral LUM-201 in PGHD – Approaching 50% Enrollment, Interim Analysis Planned
- We are approaching the 50% enrollment milestone for the OraGrowtH210 Trial, and as a result we anticipate reporting top line data from an interim analysis by the end of 2022. The interim analysis will evaluate the safety and annualized height velocity at three dose levels of LUM-201 against a standard dose of injectable recombinant human growth hormone (rhGH) in 40 subjects at six months on therapy.
- The Phase 2 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 PGHD, which is less severe than organic PGHD, when fully enrolled. 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.
- Due to the ongoing conflict between
Ukraineand Russiaand the resulting uncertainty in the region, we are unable to enroll patients in Ukraine, and all of our clinical sites in both Ukraineand Russiaare suspended until further notice. No patients had been randomized to treatment in the clinical trial at any of our nine sites in Ukraineand Russia. Given the encouraging screening and enrollment trajectory at our other clinical sites, we continue to anticipate the 6-month primary outcome data on all 80 subjects in the second half of 2023. The ongoing conflict may, however, adversely impact our business in the future, and it remains too early to evaluate the potential effects of this crisis.
- OraGrowtH212 Trial to Evaluate PK/PD and Pulsatility of Oral LUM-201 in PGHD – Interim Analysis Planned
- The OraGrowtH212 Trial continues to enroll, with an interim analysis to evaluate the safety and height velocity data anticipated by the end of 2022. Enrollment in the trial is approaching the minimum number of 10 patients for the interim analysis.
- The OraGrowtH212 Trial is a single site, open-label trial evaluating the pharmacokinetic (PK) and pharmacodynamic (PD) effects of LUM-201 in up to 24 PGHD patients 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 unique to LUM-201 and its potential for this mechanism of action to contribute to efficacy in PGHD. The primary endpoint is six months of PK/PD and height velocity data, with a total of 12 months of height velocity data to be captured.
- Switch Study, OraGrowtH213 Trial, in PGHD – Initiated
- We initiated our OraGrowtH213 Trial, an open-label, multi-center, Phase 2 study evaluating the growth effects and safety of orally administered LUM-201 following 12 months of daily injectable rhGH in up to 20 PGHD subjects 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.
Financial Results for the Year Ended
- Cash Position –
Lumos Pharmaended the year on December 31, 2021, with cash and cash equivalents totaling $94.8 millioncompared to $98.7 million on December 31, 2020. The Company expects an average cash use of approximately $8.5to $9.5 millionper quarter through 2022. Cash on hand as of year-end 2021 is expected to support operations through the primary outcome data readout from our OraGrowtH210 and OraGrowtH212 Trials anticipated in the second half of 2023.
- R&D Expenses – Research and development expenses were
$16.2 million, an increase of $7.0 million for the year ended December 31, 2021compared to the same period in 2020, primarily due to increases of $5.5 million in clinical trial and contract manufacturing expenses, $2.0 million in personnel-related expenses and $0.7 million in stock compensation expenses, offset by decreases of $0.3 million in legal and consulting expenses, $0.4 millionin operating expenses for supplies, depreciation, and rent, and $0.5 million in other expenses.
- G&A Expenses – General and administrative expenses were
$15.3 million, a decrease of $1.9 million for the year ended December 31, 2021, as compared to the same period in 2020, primarily due to decreases of $1.9 million in legal and consulting expenses, which were higher in 2020 due to merger-related expenses, $1.1 million in personnel-related expenses, and $0.5 million in operating expenses for rent, supplies, and depreciation, offset by increases of $1.0 million in stock compensation expense and $0.6 million in traveling, licensing, and other expenses.
- Net Loss – The net loss for the year ended
December 31, 2021was $30.4 millioncompared to a net loss of $5.7 millionfor the same period in 2020. Lumos Pharmaended Q4 2021 with 8,357,391 shares outstanding.
Conference Call and Webcast Details
The Company has scheduled a conference call and webcast for
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 screening and enrollment for both our OraGrowtH210 and OraGrowtH212 Trials progressing well, anticipating interim analyses of OraGrowtH210 and OraGrowtH212 Trials by the end of 2022, that the interim sample size should be adequate to provide an initial indication of LUM 201’s impact, expecting the primary outcome data readout for our OraGrowtH210 Trial in the second half of 2023, the potential to expand our LUM-201 platform into other indications, future financial performance, results of operations, cash usage and cash position and sufficiency of our cash resources to fund our operating requirements through the primary outcome data readout from 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. In addition to other considerations referenced in this paragraph, the recent conflict between
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.
Investor & Media Contact:
Lumos Pharma Investor Relations
|Consolidated Statements of Operations|
|(In thousands, except share and per share amounts)
|Licensing and collaboration revenue||$||10||$||168|
|Research and development||16,246||9,206|
|General and administrative||15,331||17,265|
|Total operating expenses||31,577||26,471|
|Loss from operations||(31,347||)||(26,303||)|
|Other income and expense:|
|Other income, net||269||6,467|
|Other income, net||281||6,667|
|Net loss before taxes||(31,066||)||(19,636||)|
|Income tax benefit||636||13,973|
|Accretion of preferred stock to current redemption value||—||(651||)|
|Net loss attributable to common shareholders||$||(30,430||)||$||(6,314||)|
|Net loss per share of common stock|
|Basic and diluted||$||(3.65||)||$||(0.93||)|
|Weighted average number of common shares outstanding|
|Basic and diluted||8,334,516||6,777,932|
|Consolidated Balance Sheets|
|(In thousands, except share and per share amounts)
|Cash and cash equivalents||$||94,809||$||98,679|
|Prepaid expenses and other current assets||4,740||3,506|
|Income tax receivable||128||115|
|Total current assets||99,677||128,449|
|Property and equipment, net||79||335|
|Total non-current assets||635||584|
|Liabilities and Stockholders' Equity|
|Current portion of lease liability||352||319|
|Total current liabilities||5,130||6,461|
|Royalty obligation payable to
|Total long-term liabilities||6,205||6,000|
|Commitments and contingencies:|
|Undesignated preferred stock,
|Additional paid-in capital||185,429||182,480|
|Total stockholders' equity||88,977||116,572|
|Total liabilities and stockholders' equity||$||100,312||$||129,033|
Source: Lumos Pharma, Inc.