Lumos Pharma Reports Full Year 2023 Financial Results and Provides Clinical Development Update
End of Phase 2 Meeting to Occur in Q2 2024, Initiation of LUM-201 Phase 3 Trial Expected in Q4 2024
Previously Announced Topline Data from Phase 2 OraGrowtH210 and OraGrowtH212 Trials of LUM-201 in Moderate PGHD Met All Primary and Secondary Endpoints
Pisit “Duke” Pitukcheewanont, MD, Appointed Chief Medical Officer
Conference Call Today at
“The past year was a highly successful one for Lumos, culminating in the announcement of topline results from our Phase 2 OraGrowtH210 and OraGrowtH212 trials, which met all of their primary endpoints and provided substantial support for the advancement of LUM-201 toward a registrational Phase 3 trial in moderate PGHD,” said
Upcoming Milestones
- Full 12-month data from OraGrowtH210 Trial to be presented in Q2 2024 at major medical meeting
- End of Phase 2 Meeting to occur in Q2 2024
- Company expects to initiate Phase 3 pivotal trial of LUM-201 in Q4 2024
Recent Highlights
- Topline Data from Phase 2 OraGrowtH210 and OraGrowtH212 Trials of LUM-201 in PGHD Met All Primary and Secondary Endpoints
- OraGrowtH210 results showed LUM-201 dose of 1.6 mg/kg achieved annualized height velocities (AHV) of 8.2 cm/yr at 6 months and 8.0 cm/yr at 12 months, similar to growth rates for moderate PGHD population
- Delta at 6 and 12-month AHV between optimal LUM-201 dose of 1.6 mg/kg and rhGH comparator arm was within the non-inferiority margin (< 2 cm/yr) suggested by FDA for recent approvals
- Initial 24-month LUM-201 data from combined OraGrowtH210 and OraGrowtH212 Trials demonstrated a sustained AHV effect from Year 1 to Year 2
- OraGrowtH212 demonstrated that, with only 20% of the GH concentration of injectable rhGH, LUM-201 achieved similar AHV, illustrating the greater efficiency of LUM-201’s unique pulsatile mechanism of action
- OraGrowtH210 Trial met pre-specified primary endpoint of validation of Predictive Enrichment Marker (PEM) test and secondary endpoint demonstrating 100% reproducibility of PEM-Positive classification
- No safety signal to date for LUM-201
- Pisit “Duke” Pitukcheewanont, MD Appointed Chief Medical Officer
Dr. Duke as he is known was promoted to the position of CMO effectiveJanuary 1, 2024 . In this role,Dr. Duke will provide his leadership in Lumos Pharma’s efforts to hone its clinical and regulatory strategy and will continue to oversee medical affairs as the Company prepares to initiate a pivotal Phase 3 trial evaluating oral LUM-201 as a therapeutic for moderate PGHD.
Financial Results for the Year Ended
- Cash Position –
Lumos Pharma ended the year onDecember 31, 2023 , with cash, cash equivalents, and short-term investments totaling$36 .1 million compared to$67 .4 million onDecember 31, 2022 . Cash on hand as ofDecember 31, 2023 , is expected to support operations through the third quarter of 2024. - R&D Expenses – Research and development expenses were
$22 .1 million, an increase of$4 .2 million for the year endedDecember 31, 2023 , compared to the same period in 2022, primarily due to increases of$3.3 million in clinical trial expenses,$0.9 million in contract manufacturing expenses,$0.2 million in consulting expenses and$0.2 million in other expenses, partially offset by a$0.4 million decrease in personnel-related expenses. - G&A Expenses – General and administrative expenses were
$16 .6 million, an increase of$0 .9 million for the year endedDecember 31, 2023 , compared to the same period in 2022, primarily due to increases of$0.5 million in personnel-related expenses,$0.4 million in royalty expenses and$0.1 million in travel expenses, partially offset by a$0.1 million decrease in other expenses. - Net Loss – The net loss for the year ended
December 31, 2023 , was$34 .0 million compared to a net loss of$31.1 million for the same period in 2022. Lumos Pharma ended Q4 2023 with 8,102,555 shares outstanding.
Conference Call and Webcast Details
The Company has scheduled a conference call and webcast for
Investors and the general public are invited to listen to the conference call. To access the call by phone, please click on this Registration Link, complete the form and you will be provided with dial-in details and a PIN. To avoid delays, we encourage participants to dial in to the conference call ten minutes ahead of the scheduled start time. The webcast may be accessed through this Webcast Link and may also be found in the “Investors & Media” section of the
About
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 the advancement of oral LUM-201 to Phase 3, the expected timing of trial data presentations and FDA meetings, substantial support for the advancement of LUM-201 toward a registrational Phase 3 trial in moderate PGHD, that we expect to present full twelve-month and longer-term data in a subset of patients from these trials at a medical meeting in the second quarter of this year, that next steps for this program are on track, that we expect to be in position to initiate this registrational trial in the fourth quarter, that there is broad support among the pediatric endocrinology community for our novel approach to treating growth hormone disorders, that we remain confident in this asset’s potential to become the first oral therapeutic for the treatment of PGHD, that cash on hand as of
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 including risks related to the continued analysis of data from our LUM-201 Trials, the timing and outcome of our future interactions with regulatory authorities including our end of Phase 2 meeting with the FDA, the timing and ability of Lumos to raise additional equity capital as needed to fund our Phase 3 Trial, our ability to project future cash utilization and reserves needed for contingent future liabilities and business operations, the ability to structure our Phase 3 trial in an effective and timely manner, the ability to successfully develop our product candidate, the effects of pandemics, other widespread health problems or military conflicts including the
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
512-792-5454
ir@lumos-pharma.com
| Consolidated Statements of Operations and Comprehensive Loss | ||||||||
| (unaudited) | ||||||||
| (In thousands, except share and per share amounts) |
||||||||
| Year Ended |
||||||||
| 2023 | 2022 | |||||||
| Revenues: | ||||||||
| Royalty revenue | $ | 2,051 | $ | 1,523 | ||||
| Total revenues | 2,051 | 1,523 | ||||||
| Operating expenses: | ||||||||
| Research and development | 22,096 | 17,857 | ||||||
| General and administrative | 16,569 | 15,706 | ||||||
| Total operating expenses | 38,665 | 33,563 | ||||||
| Loss from operations | (36,614 | ) | (32,040 | ) | ||||
| Other income and expense: | ||||||||
| Other income, net | 683 | 91 | ||||||
| Interest income | 1,868 | 874 | ||||||
| Other income, net | 2,551 | 965 | ||||||
| Net loss before taxes | (34,063 | ) | (31,075 | ) | ||||
| Income tax benefit | 29 | 13 | ||||||
| Net loss | $ | (34,034 | ) | $ | (31,062 | ) | ||
| Net loss per share of common stock | ||||||||
| Basic and diluted | $ | (4.18 | ) | $ | (3.71 | ) | ||
| Weighted average number of common shares outstanding | ||||||||
| Basic and diluted | 8,145,155 | 8,373,821 | ||||||
| Other comprehensive income (loss): | ||||||||
| Unrealized loss on short-term investments | 9 | (9 | ) | |||||
| Total comprehensive loss | $ | (34,025 | ) | $ | (31,071 | ) | ||
| Consolidated Balance Sheets | ||||||||
| (unaudited) | ||||||||
| (In thousands, except share and per share amounts) |
||||||||
| 2023 | 2022 | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 35,078 | $ | 56,007 | ||||
| Short-term investments | 999 | 11,352 | ||||||
| Prepaid expenses and other current assets | 3,748 | 4,427 | ||||||
| Other receivables | 210 | 223 | ||||||
| Total current assets | 40,035 | 72,009 | ||||||
| Non-current assets: | ||||||||
| Property and equipment, net | — | 53 | ||||||
| Right-of-use asset | 603 | 230 | ||||||
| Total assets | $ | 40,638 | $ | 72,292 | ||||
| Liabilities and Stockholders' Equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 890 | $ | 275 | ||||
| Accrued expenses | 5,858 | 6,200 | ||||||
| Current portion of lease liability | 282 | 233 | ||||||
| Total current liabilities | 7,030 | 6,708 | ||||||
| Long-term liabilities: | ||||||||
| Royalty obligation payable to |
6,000 | 6,000 | ||||||
| Lease liability | 303 | — | ||||||
| Total liabilities | 13,333 | 12,708 | ||||||
| Commitments and contingencies: | ||||||||
| Stockholders' equity: | ||||||||
| Undesignated preferred stock, |
— | — | ||||||
| Common stock, |
81 | 82 | ||||||
| (196 | ) | (170 | ) | |||||
| Additional paid-in capital | 188,937 | 187,164 | ||||||
| Accumulated deficit | (161,517 | ) | (127,483 | ) | ||||
| Accumulated other comprehensive loss | — | (9 | ) | |||||
| Total stockholders' equity | 27,305 | 59,584 | ||||||
| Total liabilities and stockholders' equity | $ | 40,638 | $ | 72,292 | ||||
Source: Lumos Pharma, Inc.