Lumos Pharma Announces the Initiation of Phase 2b OraGrowtH210 Trial and Reports Third Quarter 2020 Financial Results
Lumos Pharmahas initiated Phase 2b OraGrowtH210 Trial evaluating oral LUM-201 in pediatric growth hormone deficiency (PGHD) patients with data read-out anticipated mid-year 2022
“This past quarter was marked by significant achievements leading to the initiation of our Phase 2b OraGrowtH210 Trial evaluating oral LUM-201 in pediatric growth hormone deficiency patients and the previously announced sale of our PRV in July,” commented Rick Hawkins, Chairman, CEO and President of
- Initiation of Phase 2b OraGrowtH210 Trial -
Lumos Pharmaannounced the initiation of its Phase 2b OraGrowtH210 trial evaluating oral LUM-201 in pediatric growth hormone deficiency (PGHD) patients. The trial will evaluate three dose levels of LUM-201 in PGHD patients against a comparator arm of standard-of-care injectable growth hormone therapy. Dosing will be administered over six months, with annualized growth height velocity as the primary clinical outcome measure. The purpose of this trial will be to prospectively confirm our Predictive Enrichment Marker (PEM) strategy and to identify the optimal dose of LUM-201 to be used in a registration trial. The Company anticipates data read out for the OraGrowtH210 Trial mid-year 2022.
- Received First Tranche of PRV Sale Funds - Lumos received the first tranche of
$34 millionfrom the total $60 milliondue to the Company from the PRV sale and anticipates the receipt of the second tranche of $26 millionin Q1 2021. We anticipate these funds will serve as additional capital to support the expansion of the Company’s pipeline through the licensure of another novel therapeutic candidate for those suffering from rare diseases.
- Pharmacokinetic/Pharmacodynamic OraGrowtH212 Trial of LUM-201 in PGHD Remains on Track - The Company continues to prioritize the initiation of its second concurrent trial of LUM-201 in PGHD and remains on track to initiate the OraGrowtH212 Trial in Q1 2021.
Financial Results for the Three-Month Period Ended September 30, 2020
- Cash Position: Lumos Pharma ended the quarter on September 30, 2020, with cash and cash equivalents totaling $105.6 million compared to
Lumos Pharmaprior to its merger with NewLink Geneticscash of $5.0 million December 31, 2019 and pro forma December 31, 2019 cash of $95.5 million, inclusive of NewLink Genetics. The Company expects its cash on hand is sufficient to fund current operations through the read-out of our Phase 2b OraGrowtH210 Trial and completion of the OraGrowtH212 Trial.
- R&D Expenses: Research and development expenses for the three months ended September 30, 2020 were $2.1 million, an increase of $0.9 million from $1.2 million for the same period in 2019. The increase is primarily due to increases of
$0.7 millionin clinical trial expenses, $0.2 millionin personnel-related and stock compensation expenses, $0.2 millionin supplies and other expenses and $0.1 millionin legal expenses, offset by a decrease of $0.3 millionin contract manufacturing expense.
- G&A Expenses: General and administrative expenses for the three months ended September 30, 2020 were $5.2 million, an increase of $3.7 million from $1.5 million for the same period in 2019. The increase was due primarily to increases of
$2.6 millionin personnel-related and stock compensation expenses and $1.1 millionin operating expenses for insurance, rent, supplies, and depreciation expenses.
- Net Income (Loss): The net income for the three months ended September 30, 2020 was $1.8 million compared to a net loss of $2.7 million for the same period in 2019.
- Lumos Pharma ended Q3 2020 with 8,293,312 shares outstanding.
Conference Call and Webcast Details
The Company has scheduled a conference call and webcast for 4:30 p.m. ET today to discuss its financial results and to give an update on clinical and business development activities. There will also be a question and answer session following management’s prepared remarks.
Access to the live conference call is available five minutes prior to the start of the call by dialing (855) 469-0612 (
About Lumos Pharma
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements of Lumos Pharma, Inc. (the “Company”) that involve substantial risks and uncertainties. All such statements contained in this press release are forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. The words “forecast,” “projected,” "guidance," "upcoming," "will," “would,” "plan," “intend,” "anticipate," "approximate," "expect," “potential,” “imminent,” or the negative of these terms or other similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These forward-looking statements include, among others, our intent to initiate a Pharmacokinetic/Pharmacodynamic OraGrowtH212 study of LUM-201 in PGHD in 2021, anticipated monetization of our priority review voucher, that cash on hand is expected to fund current operations through the read-out of our Phase 2b OraGrowtH210 Trial and completion of the OraGrowtH212 Trial, that we are engaging in activities that we hope will lead to the expansion of our pipeline through the licensure of other rare disease assets, that we believe Lumos Pharma is well positioned to execute on our clinical and business development plans, the potential of an orally administered treatment regimen for PGHD and other indications, plans related to 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 its operating requirements; and any other statements other than statements of historical fact. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements that the Company makes due to a number of important factors, including the effects of pandemics or other widespread health problems such as the ongoing COVID-19 pandemic, the outcome of our future interactions with regulatory authorities, the outcome of our Phase 2b OraGrowtH210 Trial for LUM-201, our ability to project future cash utilization and reserves needed for contingent future liabilities and business operations, the availability of sufficient resources for our operations and to conduct or continue planned clinical development programs, the ability to obtain the necessary patient enrollment for our product candidate in a timely manner, the ability to successfully develop our product candidate, the risks associated with the process of developing, obtaining regulatory approval for and commercializing drug candidates such as LUM-201 that are safe and effective for use as human therapeutics, the timing and ability of Lumos to monetize its priority review voucher and raise additional equity capital as needed and other risks that could cause actual results to differ materially from those matters expressed in or implied by such forward-looking statements as discussed in "Risk Factors" and elsewhere in Lumos Pharma’s Quarterly Report on Form 10-Q for the quarter ended
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|Condensed Consolidated Statements|
|(In thousands, except share and per share amounts)|
|Three Months Ended||Nine Months Ended|
|Licensing and collaboration revenue||$||74||$||—||$||128||$||—|
|Research and development||2,075||1,202||6,743||4,538|
|General and administrative||5,156||1,496||12,634||2,893|
|Total operating expenses||7,231||2,698||19,377||7,431|
|Loss from operations||(7,157||)||(2,698||)||(19,249||)||(7,431||)|
|Other income and expense:|
|Other income, net||6,322||—||6,482||23|
|Other income, net||6,490||29||6,680||88|
|Net loss before taxes||(667||)||(2,669||)||(12,569||)||(7,343||)|
|Income tax benefit||2,432||—||9,321||—|
|Net income (loss)||$||1,765||$||(2,669||)||$||(3,248||)||$||(7,343||)|
|Accretion of preferred stock to current redemption value||—||(766||)||(651||)||(2,274||)|
|Net income (loss) attributable to common shareholders||$||1,765||$||(3,435||)||$||(3,899||)||$||(9,617||)|
|Net income (loss) per share of common stock|
|Weighted average number of common shares outstanding|
|Condensed Consolidated Balance Sheets|
|(In thousands, except share and per share amounts)|
|Cash and cash equivalents||$||105,575||$||4,952|
|Prepaid expenses and other current assets||3,230||82|
|Income tax receivable||174||—|
|Total current assets||135,155||5,069|
|Property and equipment, net||594||84|
|Total non-current assets||1,033||457|
|Liabilities, Redeemable Convertible Preferred Stock and Stockholders' Equity (Deficit)|
|Current portion of lease liability||535||189|
|Total current liabilities||6,965||1,263|
|Royalty obligation payable to
|Deferred tax liability||4,653||—|
|Total long-term liabilities||10,688||191|
|Commitments and contingencies:|
|Redeemable convertible preferred stock:|
|Series A redeemable convertible preferred stock,
|Series B redeemable convertible preferred stock,
|Stockholders' equity (deficit):|
|Undesignated preferred stock,
|Additional paid-in capital||182,028||202|
|Total stockholders' equity (deficit)||118,535||(59,463||)|
|Total liabilities, redeemable convertible preferred stock and stockholders' equity||$||136,188||$||5,526|
Source: Lumos Pharma, Inc.