Lumos Pharma Reports Full Year 2020 Financial Results and Provides Update on OraGrowtH Trials in PGHD
- Data published in the
Journal of Endocrine Societyand accepted for presentation at ENDO 2021 demonstrate distinct mechanism of action and potential efficacy of LUM-201 in subset of pediatric growth hormone deficiency (PGHD) patients
- Final tranche of
$26 millionnon-dilutive funds from PRV sale received in January 2021
“The fourth quarter and full year 2020 were marked by significant achievements for Lumos Pharma,” commented
- LUM-201 Data Published in
Journal of Endocrine Society(JES) – The manuscript, “Development of a Predictive Enrichment Marker for Oral GH Secretagogue LUM-201 in Children with Growth Hormone Deficiency,” by Bright, G., MD, et al, was published in the Journal of Endocrine Societylate February. This peer-reviewed analysis of data from prior studies of LUM-201 in pediatric growth hormone deficiency (PGHD) supports the utility of specific predictive enrichment markers (PEMs) in identifying PGHD patients likely to respond to LUM-201. The two PEMs identified after a single dose of LUM-201, baseline IGF-1 cut-off level > 30 ng/ml and peak GH level ≥ 5 ng/mL, are being used to qualify PGHD patients for enrollment in our OraGrowtH210 Trial.
- Predictive Enrichment Markers Define Subset of Moderate Growth Hormone Deficiency – The manuscript, “Corroboration Between Prediction Enrichment Markers for Height Velocity to rhGH and an Oral GH Secretagogue Treatment in Children with Moderate GHD,” by
Blum, W., PhD, et al, was published in the Journal of Endocrine Societylate February. This peer-reviewed analysis of data on children with growth hormone deficiency (GHD) in a large legacy database (GeNeSIS data) corroborates that approximately 60% of the total pediatric GHD patient population meet the definition of moderately GHD deficient (PEM-positive) and are likely to respond to a growth hormone secretagogue.
- Poster to be Presented at ENDO 2021 – The poster entitled, “LUM-201 Elicits Greater GH Response than Standard GH Secretagogues in Pediatric Growth Hormone Deficiency,“ (abstract 7102) will be presented at the
Endocrine Society2021 Annual Meeting, March 20th-23rd.
- Phase 2b OraGrowtH210 Trial Advances – The Phase 2b OraGrowtH210 Trial initiated in Q4 2020 continues to advance. This global Phase 2b trial will evaluate orally administered LUM-201 in approximately 80 patients diagnosed with PGHD. 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 Phase 3 registration trial. The Company continues to anticipate data read-out for the OraGrowtH210 Trial mid-year 2022.
- OraGrowtH212 Trial (PK/PD study) of LUM-201 in PGHD Initiation Anticipated Q2 2021 - This study will evaluate the pharmacokinetic and pharmacodynamic (PK/PD) effects of two dose levels of LUM-201 (1.6 and 3.2 mg/kg/day) in approximately 24 PGHD patients at a single specialized clinical site. The purpose of this study will be to confirm prior preclinical and clinical data supporting the increased pulsatile release of endogenous growth hormone peaks that characterizes the unique mechanism of action of LUM-201. Recently we were informed of a fire at the
San Borja Arriaran Hospitalin Santiago, Chile, which is the location of the OraGrowtH212 trial. While we had originally expected to initiate this trial in Q1 2021, we now anticipate the initiation of the OraGrowtH212 Trial to occur in Q2 2021 due to potential delays as the hospital addresses this incident. Our investigator’s clinic was not directly involved in the fire, and we continue to work with our local contacts to advance the trial. As we have previously stated, this trial is not on the critical path for regulatory approval of LUM-201, and we do not anticipate the fire will cause any delays to our previously stated regulatory approval timeline. We are exploring alternate sites to conduct the trial in the event that the original site is unable to proceed in a timely manner.
- OraGrowtH211 Trial, a Long-Term Extension Study, is Announced –
Lumos Pharmaannounced the OraGrowtH211 Trial, an extension study to determine the long-term safety, PK/PD markers and growth outcomes attributable to LUM-201 administered to children with growth hormone deficiency. The OraGrowtH211 Trial will be open to all eligible PGHD patients who have completed OraGrowtH210, OraGrowtH212 or other subsequent LUM-201 trials.
- Business Development – The Company continues to pursue opportunities to expand our rare disease pipeline through the in-licensure or acquisition of another novel therapeutic candidate for those suffering from rare diseases.
- Received Final Tranche of Funds from PRV Sale – 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 Guidance for 2021 – The Company anticipates average cash use of approximately
$8.0to $9.0 millionper quarter through 2021.
- Management Changes – As previously disclosed,
Eugene Kennedy, MD, Chief Medical Officer (CMO), departed Lumos Pharma March 4, 2021to join a privately held company focused on developing therapeutics for patients suffering from cancer. Lumos Pharmawill conduct a search for his replacement. John McKew, PhD, COO and CSO together with George Bright, MD, VP, Clinical Development and a pediatric endocrinologist, will cover all CMO responsibilities in the interim.
- Appointed New Board Member with Rare Disease Background –
February 16, 2021, Lumos Pharmaannounced the appointment of new Board member, An van Es-Johansson, M.D., with a wealth of experience in rare diseases. Dr. van Es-Johanssonrecently served as the Chief Medical Officer and Head of Development for AlzeCure Pharma, a Swedish pharmaceutical company with a primary focus on Alzheimer’s disease, where she now serves as a senior advisor. Dr. van Es-Johansson’searly work in the life science industry focused on the clinical development of recombinant human growth hormone (rhGH) therapeutics for Turner Syndrome and other endocrine disorders at both Eli Lily and Pharmacia Upjohn. Since then, Dr. van Es-Johanssonhas held leadership roles at several large and small biopharmaceutical companies and currently serves on the Board of Directors at Medivir AB, Savara Pharmaceuticals, PLUS Therapeutics, and Agendia BV. Dr. van Es-Johanssonreceived a M.D. from Erasmus University, Rotterdam, The Netherlands.
Financial Results for the Year Ended
- Cash Position –
Lumos Pharmaended the year on December 31, 2020, with cash and cash equivalents totaling $98.7 millioncompared to $5.0 millionon December 31, 2019and pro forma December 31, 2019cash 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 year ended
December 31, 2020were $9.2 million, an increase of $3.5 millionfrom $5.7 millionfor the same period in 2019. The increase is primarily due to increases of $2.4 millionin clinical trial expenses, $1.4 millionin personnel-related and stock compensation expenses, $0.8 millionin supplies and other expenses and $0.4 millionin write-off of the acquired NewLink’s in-process research and development costs, offset by a decrease of $1.5 millionin contract manufacturing expense.
- G&A Expenses – General and administrative expenses for the year ended
December 31, 2020were $17.3 million, an increase of $13.1 millionfrom $4.2 millionfor the same period in 2019. The increase was due primarily to increases of $7.0 millionin personnel-related and stock compensation expenses, $4.2 millionin operating expenses for insurance, rent, supplies, and depreciation expenses, $1.6 milliondue to the Merger related expenses and $0.6 millionin legal and consulting expenses, offset by a decrease of $0.3 millionin travel expenses.
- Net Loss – The net loss for the year ended
December 31, 2020was $5.7 millioncompared to a net loss of $9.7 millionfor the same period in 2019. Lumos Pharmaended Q4 2020 with 8,305,269 shares outstanding.
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Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements of
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|Consolidated Statements of Operations|
|(In thousands, except share and per share amounts)
|Licensing and collaboration revenue||$||168||$||—|
|Research and development||9,206||5,669|
|General and administrative||17,265||4,147|
|Total operating expenses||26,471||9,816|
|Loss from operations||(26,303||)||(9,816||)|
|Other income and expense:|
|Other income, net||6,467||37|
|Other income, net||6,667||111|
|Net loss before taxes||(19,636||)||(9,705||)|
|Income tax benefit||13,973||—|
|Accretion of preferred stock to current redemption value||(651||)||(3,040||)|
|Net loss attributable to common shareholders||$||(6,314||)||$||(12,745||)|
|Net loss per share of common stock|
|Basic and diluted||$||(0.93||)||$||(9.79||)|
|Weighted average number of common shares outstanding|
|Basic and diluted||6,777,932||1,302,390|
|Consolidated Balance Sheets|
|(In thousands, except share and per share amounts)
|Cash and cash equivalents||$||98,679||$||4,952|
|Prepaid expenses and other current assets||3,506||82|
|Income tax receivable||115||—|
|Total current assets||128,449||5,069|
|Property and equipment, net||335||84|
|Total non-current assets||584||457|
|Liabilities, Redeemable Convertible Preferred Stock and Stockholders' Equity (Deficit)|
|Current portion of lease liability||319||189|
|Total current liabilities||6,461||1,263|
|Royalty obligation payable to
|Total long-term liabilities||6,000||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, $— par value: Authorized shares - 5,000,000 at
|Additional paid-in capital||182,480||202|
|Total stockholders' equity (deficit)||116,572||(59,463||)|
|Total liabilities, redeemable convertible preferred stock and stockholders' equity||$||129,033||$||5,526|
Source: Lumos Pharma, Inc.