Lumos Pharma Reports Third Quarter 2021 Financial Results and Provides Clinical Updates
- Majority of OraGrowtH210 Trial sites are open with recent and imminent openings representing historically high enrollment sites
- Six-month primary outcome data readout from OraGrowtH210 expected 2H 2023
“During our third quarter we continued to advance our LUM-201 program for the treatment of pediatric growth hormone deficiency (PGHD), with the opening of a number of new OraGrowtH210 Trial sites,” said
OraGrowtH210 Trial of LUM-201 in PGHD
Enrollment in the Phase 2 OraGrowtH210 Trial of LUM-201 in PGHD continues, with the majority of the approximately 50 planned sites activated and open for enrollment. OraGrowtH210 is a global clinical trial and is evaluating orally administered LUM-201 in approximately 80 patients diagnosed with PGHD. The objective of the trial is to identify the optimal dose of LUM-201 based on annualized height velocity to be used in a Phase 3 registration trial and to prospectively confirm the preliminary validation of our Predictive Enrichment Marker (PEM) strategy. The Company continues to anticipate six-month data read-out for the OraGrowtH210 Trial in the second half of 2023, with additional 12-month data to be collected.
OraGrowtH212 Trial of LUM-201 in PGHD Initiated Q2 2021
The OraGrowtH212 Trial was initiated in June and is also continuing to enroll patients. OraGrowtH212 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. Given the open-label design of this trial, the Company has the ability to perform an interim analysis at its discretion. The objective of OraGrowtH212 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 additional 12-month data to be captured.
LUM-201 Life-Cycle Management
Injectable recombinant human growth hormone (rhGH) and derivative products are currently approved for multiple indications, including PGHD. LUM-201, through its unique mechanism of promoting increased secretion of endogenous GH, may have the potential to be efficacious in many of these indications.
Financial Results for the Quarter Ended
- Cash Position –
Lumos Pharmaended the third quarter on September 30, 2021, with cash and cash equivalents totaling $100.7 millioncompared to $98.7 millionon December 31, 2020. Cash on hand as of the end of Q3 2021 is expected to support operations through the primary outcome data readout from OraGrowtH210 and OraGrowtH212 Trials.
- R&D Expenses – Research and development expenses were
$4.1 million, an increase of $2.0 millionfor the three months ended September 30, 2021compared to the same period in 2020, primarily due to increases of $1.8 millionin clinical trial and contract manufacturing expenses, $0.4 millionin personnel-related expenses and $0.1 millionin stock compensation expenses, offset by a decrease of $0.3 millionin supplies and other expenses.
- G&A Expenses – General and administrative expenses were
$3.4 million, a decrease of $1.8 millionfor the three months ended September 30, 2021, as compared to the same period in 2020, primarily due to decreases of $1.3 millionin personnel-related expenses, $0.3 millionin legal, consulting and other expenses and $0.2 millionin operating expenses for insurance, rent, supplies, and depreciation.
- Net Loss – The net loss for the third quarter ended
September 30, 2021was $7.5 millioncompared to net income of $1.8 millionfor the same period in 2020. Lumos Pharmaended Q3 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, 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, 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 and sufficiency of capital 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. 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.
Investor & Media Contact:
Lumos Pharma Investor Relations
|Condensed Consolidated Statements of Operations|
|(In thousands, except share and per share amounts)
|Three Months Ended
||Nine Months Ended
|Licensing and collaboration revenue||—||74||10||128|
|Research and development||4,112||2,075||12,885||6,743|
|General and administrative||3,385||5,156||11,903||12,634|
|Total operating expenses||7,497||7,231||24,788||19,377|
|Loss from operations||(7,497||)||(7,157||)||(24,778||)||(19,249||)|
|Other income and expense:|
|Other income, net||7||6,322||19||6,482|
|Other (expense) income, net||9||6,490||(11||)||6,680|
|Net loss before taxes||(7,488||)||(667||)||(24,789||)||(12,569||)|
|Income tax benefit||—||2,432||—||9,321|
|Net income (loss)||$||(7,488||)||$||1,765||$||(24,789||)||$||(3,248||)|
|Accretion of preferred stock to current redemption value||—||—||$||—||(651||)|
|Net income (loss) attributable to common shareholders||$||(7,488||)||$||1,765||$||(24,789||)||$||(3,899||)|
|Net income (loss) per share of common stock|
|Basic and diluted||$||(0.90||)||$||0.21||$||(2.97||)||$||(0.62||)|
|Weighted average number of common shares outstanding|
|Condensed Consolidated Balance Sheets|
|(In thousands, except share and per share amounts)
|Cash and cash equivalents||$||100,650||$||98,679|
|Prepaid expenses and other current assets||4,988||3,506|
|Income tax receivable||116||115|
|Total current assets||105,754||128,449|
|Property and equipment, net||75||335|
|Total non-current assets||711||584|
|Liabilities and Stockholders' Equity|
|Current portion of lease liability||349||319|
|Total current liabilities||6,053||6,461|
|Royalty obligation payable to
|Total long-term liabilities||6,288||6,000|
|Commitments and contingencies:|
|Undesignated preferred stock,
|Additional paid-in capital||$||184,935||$||182,480|
|Total stockholders' equity||94,124||116,572|
|Total liabilities and stockholders' equity||$||106,465||$||129,033|
Source: Lumos Pharma, Inc.