Lumos Pharma, Inc. (NASDAQ:LUMO), a biopharmaceutical company
advancing an oral therapeutic candidate for Pediatric Growth
Hormone Deficiency (PGHD) through Phase 2 clinical trials, today
announced financial results for the second quarter ended June 30,
2023.
“We are pleased to confirm our expectation for
primary data readout from our two Phase 2 OraGrowtH Trials
evaluating LUM-201 in idiopathic PGHD in the fourth quarter of
2023,” said Rick Hawkins, Chairman and CEO of Lumos Pharma. “The
primary endpoint for these trials is annualized height velocity at
six months on treatment with LUM-201. Given the encouraging data
and new analysis presented at ENDO and highlighted in the Key
Opinion Leader (KOL) webinar we hosted in June, our convictions are
further reinforced that at least one of the LUM-201 dose cohorts
will meet growth expectations based on historical averages, and
that the LUM-201 mechanism of action and potency can elicit
sustained improvements in growth in the moderate PGHD patient
population. We look forward to additional analysis of LUM-201 data
to be presented at the upcoming ESPE conference in September, and
to continuing to advance our LUM-201 clinical program for
potentially the first oral therapeutic for PGHD.”
Recent Highlights
- Company reiterates Q4 2023
timing for primary outcome data readout of OraGrowtH210 &
OraGrowtH212 Trials
- Primary endpoint is annualized
height velocity (AHV) at 6 months on treatment with the prediction
of growth of 8.3 to 8.6 cm/yr based on historical data for this
moderate idiopathic PGHD population
- Other objectives of the
OraGrowtH210 Trial are to confirm the utility of the predictive
enrichment marker (PEM) strategy and determine the optimal dose for
a Phase 3 trial
- Up to 82 subjects (approximately 20
per cohort) were enrolled in the OraGrowtH210 Trial
- Up to 22 subjects (approximately 11
per cohort) were enrolled in the OraGrowtH212 Trial
- AHV data at 12 months on treatment
is expected for up to 12 subjects per OraGrowtH210 cohort and up to
7 subjects per OraGrowtH212 cohort, for a total of up to 62
subjects from both trials
- Additional AHV data at 18 and 24
months on treatment are also expected for a small number of
subjects
- As with all Phase 2 trials in PGHD,
OraGrowtH210 is not powered to show non-inferiority of AHV between
LUM-201 and the control; these Phase 2 data will support the safety
profile and the selection of a LUM-201 dose for Phase 3 wherein
non-inferiority to a control rhGH arm of < 2 cm should determine
success based on historical approvals
- Data abstract accepted for
oral presentation at upcoming European Society of
Pediatric Endocrinology (ESPE) annual meeting,
September 21-23, 2023, in The Hague, Netherlands
- Late-breaking
abstract—Deconvolution Analysis: GH secretagogue (LUM-201) enhances
growth in individuals with moderate idiopathic Pediatric Growth
Hormone Deficiency (iPGHD) by enhancing endogenous GH secretion and
increasing IGF-1, (Fernando Cassorla, MD)—accepted for oral
presentation Saturday, September 23 (9:30-10:30 AM CET)
- Positive results from
Massachusetts General Hospital (MGH) study of injectable growth
hormone in NAFLD published in Journal of Clinical Endocrinology and
Metabolism – Data support MGH pilot trial evaluating oral LUM-201
in same indication
- Growth Hormone Administration
Improves Nonalcoholic Fatty Liver Disease in Overweight/Obesity: A
Randomized Trial—Dichtel, et al.
- Investigators hypothesized that
growth hormone may reduce hepatic steatosis in obese subjects with
NAFLD
- Subjects were randomly assigned to
a treatment group (27 GH; 26 placebo), with 41 completers (20 GH
and 21 placebo) at 6 months.
- Reduction in absolute %
Intrahepatic Lipid (IHL) content by proton magnetic resonance
spectroscopy was significantly greater in the GH vs placebo
cohorts
- Investigators concluded that GH
reduces liver fat without commensurate weight loss; data support
evaluation of oral LUM-201 in the same indication (NAFLD)
- The LUM-201 pilot trial in NAFLD
continues to enroll; the Company’s primary near-term focus remains
on advancing LUM-201 in PGHD
- New LUM-201 data and
analysis presented at ENDO 2023, highlighted in KOL
webinar
- Data from two oral presentations
presented at ENDO were highlighted by two distinguished KOLs in a
webinar held on June 21, 2023. Details included:
- New data from the OraGrowtH212
Trial showed an increase in IGF-1 levels on LUM-201 at 6 months
that remained within normal range, an increase in IGF-1 SDS to >
0, and a durable growth response after 12 months of LUM-201
administration; clear evidence of potential drug effect for LUM-201
was also observed in consistent improvement in AHV over
baseline
- New analysis of combined
OraGrowtH210 and OraGrowtH212 trial data at the 1.6 mg/kg/day and
3.2mg/kg/day dose levels (15 subjects from OraGrowtH212, 20
subjects from OraGrowtH210): results continue to demonstrate that
there is a durable response to LUM-201 from 6 to 12 months
- A replay of the webinar is here and
the presented slides are available here
Financial Results for the Quarter Ended
June 30, 2023
Cash Position – Lumos Pharma
ended the quarter on June 30, 2023 with cash, cash equivalents
and short-term investments totaling $50.9 million compared to
$67.4 million on December 31, 2022. The Company expects
an average cash use of approximately $9.5 to $10.5 million per
quarter through 2023. Cash on hand as of June 30, 2023 is
expected to support operations for at least 12 months following the
date of the filing of our second quarter 2023 financial
statements.
R&D Expenses – Research and
development expenses increased by $1.4 million for the three months
ended June 30, 2023 compared to the same period in 2022 primarily
due to increases of $1.1 million in contract manufacturing
expenses, $0.4 million in clinical trial expenses and $0.1 million
in personnel-related expenses, offset by a $0.2 million decrease in
consulting expenses.
G&A Expenses – General and
administrative expenses increased by $0.5 million for the three
months ended June 30, 2023 compared to the same period in 2022
primarily due to increases of $0.2 million in personnel-related
expenses, $0.1 million in stock compensation expenses, $0.1 million
in travel expenses and $0.1 million in royalty expenses.
Net Loss – The net loss for the
quarter ended June 30, 2023 was $8.9 million compared to
a net loss of $7.8 million for the same period in 2022.
Lumos Pharma ended Q2 2023 with 8,041,345 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 programs. There will also be a
question-and-answer session following management’s prepared
remarks.
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 into 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 Lumos Pharma website, under “Events
& Presentations.” A replay of the call will be available after
the date of the call and may be accessed through the same link
above or found on our website.
About Lumos Pharma’s Clinical
Trials
Phase 2 OraGrowtH210 Trial of Oral LUM-201 in
PGHD
The OraGrowtH210 Trial is a multi-site, global
trial evaluating orally administered LUM-201 at three dose levels
(0.8, 1.6, 3.2 mg/kg/day) against a standard dose of injectable
rhGH in approximately 80 subjects diagnosed with idiopathic
(moderate) PGHD, which is less severe than organic PGHD. The
objective of this trial is to identify the optimal dose of LUM-201
to be used in a Phase 3 registration trial, based on annualized
height velocity from a 6-month dataset, and to prospectively
confirm the preliminary validation of our Predictive Enrichment
Marker (PEM) strategy. The complete set of 6-month, primary outcome
data for 82 subjects is anticipated in the fourth quarter of 2023.
Subjects will be dosed for a total of 24 months.
OraGrowtH212 Trial Evaluating PK/PD and
Pulsatility of Oral LUM-201 in PGHD
The OraGrowtH212 Trial is a single site,
open-label trial evaluating the pharmacokinetic (PK) and
pharmacodynamic (PD) effects of oral LUM-201 in up to 24 PGHD
subjects at two dose levels, 1.6 and 3.2 mg/kg/day. The primary
objective of the OraGrowtH212 Trial is to confirm prior clinical
data demonstrating the amplified pulsatile release of endogenous
growth hormone from LUM-201 therapy, contributes to its efficacy in
PGHD. The primary endpoint for this trial is 6 months of PK/PD
(pulsatility) and height velocity data in the randomized subjects.
Subjects will be allowed to remain on treatment until they reach a
bone age of 14 for females and 16 for males reflecting near-adult
height. Primary data readout in 22 subjects is anticipated in the
fourth quarter of 2023.
Switch Study, OraGrowtH213 Trial, Evaluating
LUM-201 in OraGrowtH210 Subjects Previously on rhGH
The OraGrowtH213 Trial is an open-label,
multi-center, Phase 2 study evaluating the growth effects and
safety of LUM-201 following 12 months of daily rhGH in up to 20
idiopathic PGHD patients who have completed the OraGrowtH210 Trial.
Subjects will be administered LUM-201 at a dose level of 3.2
mg/kg/day for up to 12 months.
Lumos Pharma Collaboration with Massachusetts
General Hospital Evaluating LUM-201 in NAFLD
Lumos Pharma has entered a collaboration with
Massachusetts General Hospital (MGH) to evaluate LUM-201 in
patients with nonalcoholic fatty liver disease (NAFLD). GH is a
critical stimulator of lipolysis, and shows anti-inflammatory
effects, and preclinical data suggest that amplifying GH secretion
has the potential to reduce hepatic steatosis and prevent NAFLD
progression. Interestingly, enhancing the natural pulsatile release
of GH has been shown clinically in short-term studies to be more
efficacious in inducing lipolysis than continuous infusions of GH.
This MGH investigator-initiated trial is a single-site, 6-month,
open-label pilot study of daily oral LUM-201 in adults with NAFLD.
The trial will evaluate a dose of 25 mg/day of LUM-201 in 10
subjects with NAFLD and relative IGF-1 deficiency. The primary
endpoints will be to determine the reduction in liver lipid
content, inflammation, and fibrosis in these subjects administered
LUM-201 compared to each subject’s baseline.
About Lumos Pharma
Lumos Pharma, Inc. is a clinical stage
biopharmaceutical company focused on the development and
commercialization of therapeutics for rare diseases. The Company
was founded and is led by a management team with longstanding
experience in rare disease drug development. Lumos Pharma’s lead
therapeutic candidate, LUM-201, is a novel, oral growth hormone
(GH) secretagogue, seeking to transform the $4.5B global GH market
from injectable to oral therapy. LUM-201 is currently being
evaluated in multiple Phase 2 clinical studies in Pediatric Growth
Hormone Deficiency (PGHD) and has received Orphan Drug Designation
in both the US and EU. For more information, please visit
https://lumos-pharma.com/.
Cautionary Note Regarding
Forward-Looking Statements
This press release contains forward-looking
statements of Lumos Pharma, Inc. 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. A law that, in part,
gives us the opportunity to share our outlook for the future
without fear of litigation if it turns out our predictions were not
correct.
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 therapeutics that are safe, efficacious,
and offer a 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, progress in our clinical efforts
including the timing of expected results on our LUM-201 trials and
our ability to continue advancing our trials, encouraging interim
data and new analysis presented, that our convictions are further
reinforced that at least one of the LUM-201 dose cohorts will meet
growth expectations based on historical averages, that the LUM-201
mechanism of action and potency can elicit sustained improvements
in growth in the moderate PGHD patient population, looking forward
to additional analysis of LUM-201 data to be presented at the
upcoming ESPE conference, continuing to advance our LUM-201
clinical program for potentially the first oral therapeutic for
PGHD, that growth hormone may reduce hepatic steatosis in obese
subjects with NAFLD, future financial performance, results of
operations, our expected average cash use per quarter through 2023
and that cash on hand as of June 30, 2023 is expected to support
operations for the next 12 months and any other statements other
than statements of historical fact.
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 final results of our
LUM-201 Trials being different than our interim results, the
outcome of our future interactions with regulatory authorities, the
timing and ability of Lumos to raise additional equity capital as
needed to fund our Phase 3 Trial or for other purposes, our ability
to project future cash utilization and reserves needed for
contingent future liabilities and business operations, the ability
to obtain and maintain the necessary patient enrollment for our
product candidate in a timely manner, the ability to successfully
develop our product candidate, the effects of pandemics, other
widespread health problems or military conflicts including the
Ukraine-Russia conflict and other risks that could cause actual
results to differ materially from those matters expressed in or
implied by such forward-looking statements including information in
the "Risk Factors" section and elsewhere in Lumos Pharma’s Annual
Report on Form 10-K for the year ended December 31, 2022, as well
as other reports filed with the SEC. All of these documents are
available on our website. Before making any decisions concerning
our stock, you should read and understand those documents.
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:
Lisa MillerLumos Pharma Investor
Relations512-792-5454ir@lumos-pharma.com
Lumos Pharma, Inc. |
Condensed Consolidated Statements of Operations and
Comprehensive Loss |
(unaudited) |
(In thousands, except share and per share
amounts) |
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended June 30, |
|
Six Months Ended June 30, |
|
|
|
2023 |
|
|
|
2022 |
|
|
|
2023 |
|
|
|
2022 |
|
Revenues: |
|
|
|
|
|
|
|
|
Royalty revenue |
|
$ |
527 |
|
|
$ |
403 |
|
|
$ |
1,218 |
|
|
$ |
514 |
|
Total revenues |
|
|
527 |
|
|
|
403 |
|
|
|
1,218 |
|
|
|
514 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
Research and development |
|
|
6,024 |
|
|
|
4,645 |
|
|
|
10,393 |
|
|
|
8,866 |
|
General and administrative |
|
|
4,146 |
|
|
|
3,682 |
|
|
|
8,503 |
|
|
|
7,303 |
|
Total operating expenses |
|
|
10,170 |
|
|
|
8,327 |
|
|
|
18,896 |
|
|
|
16,169 |
|
Loss from operations |
|
|
(9,643 |
) |
|
|
(7,924 |
) |
|
|
(17,678 |
) |
|
|
(15,655 |
) |
Other income and expense: |
|
|
|
|
|
|
|
|
Other income, net |
|
|
124 |
|
|
|
6 |
|
|
|
243 |
|
|
|
12 |
|
Interest income |
|
|
559 |
|
|
|
74 |
|
|
|
1,129 |
|
|
|
79 |
|
Other income, net |
|
|
683 |
|
|
|
80 |
|
|
|
1,372 |
|
|
|
91 |
|
Net loss before taxes |
|
|
(8,960 |
) |
|
|
(7,844 |
) |
|
|
(16,306 |
) |
|
|
(15,564 |
) |
Income tax benefit |
|
|
29 |
|
|
|
— |
|
|
|
29 |
|
|
|
— |
|
Net loss |
|
$ |
(8,931 |
) |
|
$ |
(7,844 |
) |
|
$ |
(16,277 |
) |
|
$ |
(15,564 |
) |
|
|
|
|
|
|
|
|
|
Net loss per share: |
|
|
|
|
|
|
|
|
Basic and diluted |
|
$ |
(1.09 |
) |
|
$ |
(0.94 |
) |
|
$ |
(1.98 |
) |
|
$ |
(1.86 |
) |
|
|
|
|
|
|
|
|
|
Weighted average number of
common shares outstanding: |
|
|
|
|
|
|
|
|
Basic and diluted |
|
|
8,164,603 |
|
|
|
8,366,445 |
|
|
|
8,205,625 |
|
|
|
8,361,907 |
|
|
|
|
|
|
|
|
|
|
Other comprehensive loss: |
|
|
|
|
|
|
|
|
Unrealized loss on short-term investments |
|
|
(6 |
) |
|
|
— |
|
|
|
(2 |
) |
|
|
— |
|
Total comprehensive loss |
|
$ |
(8,937 |
) |
|
$ |
(7,844 |
) |
|
$ |
(16,279 |
) |
|
$ |
(15,564 |
) |
Lumos Pharma, Inc. |
Condensed Consolidated Balance Sheets |
(In thousands, except share and per share
amounts) |
|
June 30, |
|
December 31, |
|
|
2023 |
|
|
|
2022 |
|
|
(unaudited) |
|
|
Assets |
|
|
|
Current assets: |
|
|
|
Cash and cash equivalents |
$ |
37,862 |
|
|
$ |
56,007 |
|
Short-term investments |
|
12,989 |
|
|
|
11,352 |
|
Prepaid expenses and other current assets |
|
4,899 |
|
|
|
4,427 |
|
Other receivables |
|
233 |
|
|
|
223 |
|
Total current assets |
|
55,983 |
|
|
|
72,009 |
|
Non-current assets: |
|
|
|
Property and equipment, net |
|
45 |
|
|
|
53 |
|
Right-of-use asset |
|
345 |
|
|
|
230 |
|
Total assets |
$ |
56,373 |
|
|
$ |
72,292 |
|
Liabilities and
Stockholders' Equity |
|
|
|
Current liabilities: |
|
|
|
Accounts payable |
$ |
279 |
|
|
$ |
275 |
|
Accrued expenses |
|
6,087 |
|
|
|
6,200 |
|
Current portion of lease liability |
|
179 |
|
|
|
233 |
|
Total current liabilities |
|
6,545 |
|
|
|
6,708 |
|
Long-term liabilities: |
|
|
|
Royalty obligation payable to Iowa Economic Development
Authority |
|
6,000 |
|
|
|
6,000 |
|
Lease liability |
|
167 |
|
|
|
— |
|
Total liabilities |
|
12,712 |
|
|
|
12,708 |
|
Commitments and
contingencies: |
|
|
|
Stockholders' equity: |
|
|
|
Undesignated preferred stock, $0.01 par value: Authorized shares -
5,000,000 at June 30, 2023 and December 31, 2022; issued
and outstanding shares - 0 at June 30, 2023 and
December 31, 2022 |
|
— |
|
|
|
— |
|
Common stock, $0.01 par value: Authorized shares - 75,000,000 at
June 30, 2023 and December 31, 2022; issued 8,061,920 and
8,283,708 at June 30, 2023 and December 31, 2022,
respectively and outstanding shares - 8,041,345 and 8,267,968 at
June 30, 2023 and December 31, 2022, respectively |
|
80 |
|
|
|
82 |
|
Treasury stock, at cost, 20,575 and 15,740 shares at June 30,
2023 and December 31, 2022, respectively |
|
(187 |
) |
|
|
(170 |
) |
Additional paid-in capital |
|
187,539 |
|
|
|
187,164 |
|
Accumulated deficit |
|
(143,760 |
) |
|
|
(127,483 |
) |
Accumulated other comprehensive loss |
|
(11 |
) |
|
|
(9 |
) |
Total stockholders' equity |
|
43,661 |
|
|
|
59,584 |
|
Total liabilities and
stockholders' equity |
$ |
56,373 |
|
|
$ |
72,292 |
|
|
|
|
|
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