Lumos Pharma Reports First Quarter 2021 Financial Results and Provides Clinical and Corporate Updates
- Newly released PK/PD data from prior study in PGHD support endogenous LUM-201 MOA and use of Predictive Enrichment Markers (PEMs) to identify patients likely to respond to LUM-201
- Data presented at ENDO 2021 differentiate LUM-201 from standard GH secretagogues and show its potential to stimulate greater GH secretion
“The first quarter of 2021 was notable for data published further supporting the differentiated mechanism of action of LUM-201 and its potential for efficacy in patients with pediatric growth hormone deficiency identified by our Predictive Enrichment Marker strategy,” commented
- PK/PD Data for LUM-201 in PGHD Presented by Investigator at KOL Event – Newly released data from a prior PK/PD trial evaluating LUM-201 in PGHD patients was presented in April by Dr.
Fernando Cassorlaat a KOL event hosted by Lumos Pharma. These data on three PGHD patients demonstrate the potential for Predictive Enrichment Markers of baseline IGF-1 levels and peak stimulated GH levels to identify patients likely to respond to LUM-201. These data further illustrate the potential for LUM-201 to augment the pulsatile secretion of GH for 24 hours, and induce a substantial increase in height velocity, over six-months of treatment in PEM-positive patients.
- Poster Presented at ENDO 2021 Differentiates LUM-201 from Standard GH Secretagogues – The poster entitled, “LUM-201 Elicits Greater GH Response than Standard GH Secretagogues in Pediatric Growth Hormone Deficiency,“ was presented at the
Endocrine Society2021 Annual Meeting, March 20th-23rd. These data showed GH responses to single oral doses of LUM-201 were substantially higher than those elicited by standard GH secretagogues in two stimulation tests and that the difference in responses increased with higher baseline IGF-1 and higher GH stimulation test results.
- Phase 2b OraGrowtH210 Trial Continues to Advance – The Phase 2b OraGrowtH210 Trial initiated in Q4 2020 continues to add clinical sites and enroll patients. Over 50% of the trial sites are currently open with additional sites to open more imminently as we advance toward our target of 40-50 sites. This trial will evaluate orally administered LUM-201 in approximately 80 patients diagnosed with PGHD. The purpose of the OraGrowtH210 Trial will be to prospectively confirm both the repeatability of our selected Predictive Enrichment Markers (PEMs) and the validity of our PEM strategy, and to identify the optimal dose of LUM-201 to be used in a Phase 3 registration trial. The Company continues to anticipate data read-out for the OraGrowtH210 Trial mid-year 2022.
- Initiation of PK/PD OraGrowtH212 Trial of LUM-201 in PGHD Anticipated Q2 2021 – This study will evaluate the PK/PD effects of LUM-201 in PGHD patients at two dose levels to confirm prior clinical data illustrating the increased pulsatile release of endogenous growth hormone unique to LUM-201 and its potential for efficacy in a sizable PGHD patient population identified by Predictive Enrichment Markers (PEMs). We continue to anticipate the initiation of this trial in Q2 2021.
- Final Tranche of Funds from PRV Sale Received – In
January 2021, Lumos received the second and final tranche of $26.0 millionfrom the total $60.0 milliondue to the Company from the PRV sale. We anticipate these funds will serve as additional capital to support the expansion of the Company’s pipeline through its business development efforts.
Financial Results for the Quarter Ended
- Cash Position –
Lumos Pharmaended the first quarter on March 31, 2021, with cash and cash equivalents totaling $114.1 millioncompared to $98.7 millionon December 31, 2020. The Company expects an average cash use of approximately $8.0to $9.0 millionper quarter through 2021. Cash on hand as of the end of Q1 is expected to support operations through OraGrowtH210 readout and completion of the OraGrowtH212 Trial.
- R&D Expenses – Research and development expenses increased by
$2.8 millionfor the three months ended March 31, 2021compared to the same period in 2020 primarily due to increases of $1.6 millionin personnel-related and stock compensation expenses, $1.3 millionin clinical trial and contract manufacturing expenses, $0.2 millionin supplies and other expenses and $0.1 millionin legal expenses, offset by a decrease of $0.4 millionin expensed IPR&D.
- G&A Expenses – General and administrative expenses increased by
$0.6 millionfor the three months ended March 31, 2021as compared to the same period in 2020 primarily due to increases of $0.9 millionin personnel-related and stock compensation expenses and $0.5 millionin operating expenses for insurance, rent, supplies, and depreciation expenses, offset by a decrease of $0.8 millionin legal and consulting.
- Net Loss – The net loss for the first quarter ended
March 31, 2021was $8.6 millioncompared to net income of $0.3 millionfor the same period in 2020. Lumos Pharmaended Q1 2021 with 8,332,193 shares outstanding.
Conference Call and Webcast Details
The Company has scheduled a conference call and webcast for
Access to the live conference call is available five minutes prior to the start of the call by dialing (855) 469-0612 (
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements of
Investor & Media Contact:
Lumos Pharma Investor Relations
|Condensed Consolidated Statements of Operations|
|(In thousands, except share and per share amounts)
|Three Months Ended
|Licensing and collaboration revenue||$||—||$||21|
|Research and development||4,660||1,905|
|General and administrative||3,957||3,331|
|Total operating expenses||8,617||5,236|
|Loss from operations||(8,617||)||(5,215||)|
|Other income and expense:|
|Other income, net||20||136|
|Other (expense) income, net||(14||)||92|
|Net loss before taxes||(8,631||)||(5,123||)|
|Income tax benefit||—||5,463|
|Net (loss) income||$||(8,631||)||$||340|
|Accretion of preferred stock to current redemption value||—||(651||)|
|Net loss attributable to common shareholders||$||(8,631||)||$||(311||)|
|Net loss per share of common stock|
|Basic and diluted||$||(1.04||)||$||(0.14||)|
|Weighted average number of common shares outstanding|
|Basic and diluted||8,316,888||2,189,758|
|Condensed Consolidated Balance Sheets|
|(In thousands, except share and per share amounts)
|Cash and cash equivalents||$||114,101||$||98,679|
|Prepaid expenses and other current assets||5,306||3,506|
|Income tax receivable||115||115|
|Total current assets||119,601||128,449|
|Property and equipment, net||100||335|
|Total non-current assets||461||584|
|Liabilities and Stockholders' Equity|
|Current portion of lease liability||261||319|
|Total current liabilities||4,984||6,461|
|Royalty obligation payable to
|Total long-term liabilities||6,106||6,000|
|Commitments and contingencies:|
|Undesignated preferred stock, $— par value: Authorized shares - 5,000,000 at
|Additional paid-in capital||183,555||182,480|
|Total stockholders' equity||108,972||116,572|
|Total liabilities and stockholders' equity||$||120,062||$||129,033|
Source: Lumos Pharma, Inc.