- Lumos Pharma has initiated Phase 2b OraGrowtH210 Trial evaluating oral LUM-201 in pediatric growth hormone deficiency (PGHD) patients with data read-out anticipated mid-year 2022
AUSTIN, TX, USA I November 10, 2020 ILumos Pharma, Inc. (NASDAQ:LUMO), a clinical-stage biopharmaceutical company focused on therapeutics for rare diseases, announced financial results for the third quarter ended September 30, 2020 and provided an update on clinical activities.
“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 Lumos Pharma. “We are thrilled to advance our LUM-201 program and look forward to building upon this momentum as we continue our efforts to expand our business and pipeline.”
Corporate Updates
- Initiation of Phase 2b OraGrowtH210 Trial – Lumos Pharma announced 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 million from the total $60 million due to the Company from the PRV sale and anticipates the receipt of the second tranche of $26 million in 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 Pharma prior to its merger with NewLink Genetics cash 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 million in clinical trial expenses, $0.2 million in personnel-related and stock compensation expenses, $0.2 million in supplies and other expenses and $0.1 million in legal expenses, offset by a decrease of $0.3 million in 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 million in personnel-related and stock compensation expenses and $1.1 million in 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 (U.S.) or (484) 756-4268 (international). The conference call will be webcast live and a link to the webcast can be accessed through the Lumos Pharma website at www.lumos-pharma.com in the “Investors & Media” section under “Events and Presentations” or through this link: https://edge.media-server.com/mmc/p/upsndx4s. To ensure a timely connection, it is recommended that users register at least 10 minutes prior to the scheduled webcast. A replay of the call will be available approximately two hours after the completion of the call and can be accessed by dialing (855) 859-2056 (U.S.) or (404) 537-3406 (international) and using the passcode 1076873. The replay will be available for two weeks from the date of the call.
About Lumos Pharma
Lumos Pharma, Inc. is a clinical stage biopharmaceutical company focused on the development and commercialization of therapeutics for rare diseases. Lumos Pharma was founded and is led by a management team with longstanding experience in rare disease drug development and received early funding from leading healthcare investors, including Deerfield Management, a fund managed by Blackstone Life Sciences, Roche Venture Fund, New Enterprise Associates (NEA), Santé Ventures, and UCB. Lumos Pharma’s lead therapeutic candidate is LUM-201, an oral growth hormone stimulating small molecule for the treatment of Pediatric Growth Hormone Deficiency (PGHD). If approved by the FDA, LUM-201 would provide an orally administered alternative to daily injections that current PGHD patients endure for many years of treatment. LUM-201 has received Orphan Drug Designation in both the US and EU. For more information, please visit www.lumos-pharma.com.
SOURCE: Lumos Pharma
Post Views: 78
- Lumos Pharma has initiated Phase 2b OraGrowtH210 Trial evaluating oral LUM-201 in pediatric growth hormone deficiency (PGHD) patients with data read-out anticipated mid-year 2022
AUSTIN, TX, USA I November 10, 2020 ILumos Pharma, Inc. (NASDAQ:LUMO), a clinical-stage biopharmaceutical company focused on therapeutics for rare diseases, announced financial results for the third quarter ended September 30, 2020 and provided an update on clinical activities.
“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 Lumos Pharma. “We are thrilled to advance our LUM-201 program and look forward to building upon this momentum as we continue our efforts to expand our business and pipeline.”
Corporate Updates
- Initiation of Phase 2b OraGrowtH210 Trial – Lumos Pharma announced 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 million from the total $60 million due to the Company from the PRV sale and anticipates the receipt of the second tranche of $26 million in 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 Pharma prior to its merger with NewLink Genetics cash 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 million in clinical trial expenses, $0.2 million in personnel-related and stock compensation expenses, $0.2 million in supplies and other expenses and $0.1 million in legal expenses, offset by a decrease of $0.3 million in 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 million in personnel-related and stock compensation expenses and $1.1 million in 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 (U.S.) or (484) 756-4268 (international). The conference call will be webcast live and a link to the webcast can be accessed through the Lumos Pharma website at www.lumos-pharma.com in the “Investors & Media” section under “Events and Presentations” or through this link: https://edge.media-server.com/mmc/p/upsndx4s. To ensure a timely connection, it is recommended that users register at least 10 minutes prior to the scheduled webcast. A replay of the call will be available approximately two hours after the completion of the call and can be accessed by dialing (855) 859-2056 (U.S.) or (404) 537-3406 (international) and using the passcode 1076873. The replay will be available for two weeks from the date of the call.
About Lumos Pharma
Lumos Pharma, Inc. is a clinical stage biopharmaceutical company focused on the development and commercialization of therapeutics for rare diseases. Lumos Pharma was founded and is led by a management team with longstanding experience in rare disease drug development and received early funding from leading healthcare investors, including Deerfield Management, a fund managed by Blackstone Life Sciences, Roche Venture Fund, New Enterprise Associates (NEA), Santé Ventures, and UCB. Lumos Pharma’s lead therapeutic candidate is LUM-201, an oral growth hormone stimulating small molecule for the treatment of Pediatric Growth Hormone Deficiency (PGHD). If approved by the FDA, LUM-201 would provide an orally administered alternative to daily injections that current PGHD patients endure for many years of treatment. LUM-201 has received Orphan Drug Designation in both the US and EU. For more information, please visit www.lumos-pharma.com.
SOURCE: Lumos Pharma
Post Views: 78
