Biora Therapeutics, Inc. (Nasdaq: BIOR), the biotech company that
is reimagining therapeutic delivery, today provided a corporate
update and reported financial results for the fourth quarter
and year ended December 31, 2023.
“We are thrilled by the results from the single ascending dose
(SAD) portion of our clinical trial for BT-600. The data indicate
exactly what we had hoped: NaviCap devices consistently delivered
tofacitinib directly to the colon, resulting in systemic drug
levels three to four times lower than conventional oral delivery.
This demonstrates the NaviCap platform’s unique ability for
targeted delivery to the colon, and is consistent with potentially
higher drug levels in colon tissue at the site of the disease,”
said Adi Mohanty, Chief Executive Officer of Biora
Therapeutics.
“We eagerly anticipate the conclusion of the multiple ascending
dose (MAD) portion of the trial during the second quarter of 2024,
which will provide additional insight into the performance of
BT-600. We are working to create a new treatment paradigm that
leads to better outcomes for patients suffering from ulcerative
colitis, and we are encouraged by the data so far,” stated Mr.
Mohanty.
“Meanwhile, our BioJet platform is progressing well. We just
completed animal studies with another collaborator molecule, and we
remain focused on our planned goal of progressing to partnerships
this year,” continued Mr. Mohanty.
Fourth Quarter and Full-Year 2023 and Recent
Highlights
NaviCap™ Targeted Oral Delivery Platform and BT-600 in
ulcerative colitis
- Completion of SAD Portion of
Phase 1 Clinical Trial for BT-600. Results from the
single-ascending dose (SAD) portion of the trial were consistent
with desired performance targets:
- NaviCap devices were well tolerated by
study subjects in the SAD cohort.
- All participants who received devices
containing active drug showed systemic drug absorption, indicating
that the NaviCap devices released and delivered drug as
intended.
- Measurable tofacitinib in blood
was first observed at approximately six hours, with maximal
concentrations at approximately eight hours post ingestion, which
is indicative of drug delivery and absorption in the colon, as
intended.
- Plasma levels of tofacitinib were
approximately 3-4 times lower than what is observed with
conventional oral tofacitinib at the same doses, which is a
positive sign consistent with passage of drug through the colonic
tissue and into systemic circulation.
- Dose-proportional pharmacokinetics were
also observed, with consistently lower plasma drug concentrations
with the 5 mg dose than the 10 mg dose.
BioJet™ Systemic Oral Delivery Platform preclinical
development
- BioJet Research
Collaborations. Biora has now successfully performed
animal studies with peptides, antibodies, and nucleic acids,
exceeding its performance target of 15% bioavailability compared to
IV administration, and achieving 30-40% bioavailability with its
most recent studies. The company recently completed animal studies
with another large pharma research collaborator; final study data
is anticipated during Q2.
Capital Markets
- Optimization of Capital
Structure. During 2023, Biora reduced its outstanding
notes by more than $80 million, resulting in a 75% reduction in net
debt. With an additional note exchange in March 2024, the company
has brought in a total of $19.8 million in new investment through
these transactions, demonstrating continued support from
institutional investors.
- Resolution of Legacy
Matters. Biora recently monetized its investment in
Enumera Molecular, Inc., generating $3 million in non-dilutive
capital, and also reached an agreement in principle to resolve a
legacy securities litigation matter. The company believes that
remaining legacy issues will have minimal impact on Biora going
forward.
Anticipated Milestones
NaviCap™ Targeted Oral Delivery Platform and BT-600 in
ulcerative colitis
- Conclusion of the Phase 1 clinical
trial of BT-600 is anticipated. The company expects to receive
final SAD/MAD data, including colon tissue biopsy results, during
Q2 2024 and plans to present topline data from the trial shortly
afterward.
- A clinical study in active ulcerative
colitis patients is planned during the second half of 2024.
BioJet™ Systemic Oral Delivery Platform development
- The company expects data from a
recently completed animal study with its newest large
pharmaceutical collaborator during Q2.
- An update on data from recent animal
studies will be shared at the Next Gen Peptide Formulation &
Delivery Summit in June 2024.
- Biora anticipates continued progress
toward a partnership agreement for the BioJet platform.
Fourth Quarter and Full-Year 2023 Financial
Results |
Comparison of Three Months Ended December 31, 2023
and September 30, 2023
Operating expenses were $13.3 million for the three months ended
December 31, 2023, compared to $23.3 million for the three
months ended September 30, 2023. The decrease was primarily
attributable to a one-time stock-based compensation non-cash charge
of approximately $9.0 million related to vesting of employees'
restricted stock units (RSUs) in Q3 2023.
Net loss was $15.4 million and net loss per share was $0.62 for
the three months ended December 31, 2023, compared to a net
loss of $73.5 million and net loss per share of $4.89 for the three
months ended September 30, 2023. Q4 2023 includes non-cash charges
of $6.4 million attributable to the December convertible notes
exchange and $3.0 million impairment on equity investments. Q3 2023
includes non-cash charges to stock-based compensation expense of
$9.0 million noted above and a non-cash charge of $53.2 million
attributable to the convertible notes exchange implemented by the
company in September 2023.
Net gain from discontinued operations was $0.2 million and net
gain per share was $0.01 for the three months ended
December 31, 2023. There was no gain or loss from
discontinued operations for the three months ended September 30,
2023.
Comparison of Three Months Ended December 31, 2023
and 2022
Operating expenses were $13.3 million for the three months ended
December 31, 2023, compared to $13.8 million for the three
months ended December 31, 2022.
Net loss was $15.4 million and net loss per share was $0.62 for
the three months ended December 31, 2023, compared to a net
loss of $13.7 million and net loss per share of $1.64 for the three
months ended December 31, 2022.
Net gain from discontinued operations was $0.2 million and net
gain per share was $0.01 for the three months ended December 31,
2023 compared to net loss from discontinued operations of $0.3
million and net loss per share of $0.03 for the three months ended
December 31, 2022.
Comparison of Full-Year Ended December 31, 2023 and
2022
Operating expenses were $67.1 million for the year ended
December 31, 2023, compared to $62.1 million for the year
ended December 31, 2022.
Net loss was $124.1 million and net loss per share was $7.87 for
the year ended December 31, 2023, compared to a net loss of
$38.2 million and net loss per share of $5.00 for the year ended
December 31, 2022. This includes non-cash charges to
stock-based compensation expense of $9.0 million related to vesting
of employees' restricted stock units (RSUs) in Q3 2023, a non-cash
charge of $53.2 million attributable to the convertible notes
exchange implemented by the company in September 2023, an
extinguishment loss on the convertible notes exchange implemented
by the company in December 2023, and an impairment loss on equity
investments.
Net gain from discontinued operations was $0.2 million and net
gain per share was $0.01 for the year ended December 31, 2023,
compared to net gain from discontinued operations of $10.7 million
and net gain per share of $1.40 for the year ended December 31,
2022.
Conference Call and Webcast Information
Date: |
|
Tuesday, March 26, 2024 |
Time: |
|
4:30 PM Eastern time / 1:30 PM Pacific time |
Conference Call: |
|
Domestic 1-877-423-9813 International 1-201-689-8573 Conference ID
13744533Call me for instant telephone access |
Webcast: |
|
https://investors.bioratherapeutics.com/events-presentations |
About Biora Therapeutics
Biora Therapeutics is reimagining therapeutic delivery. By
creating innovative smart pills designed for targeted drug delivery
to the GI tract, and systemic, needle-free delivery of
biotherapeutics, the company is developing therapies to improve
patients’ lives.
Biora is focused on development of two therapeutics platforms:
the NaviCap™ targeted oral delivery platform, which is designed to
improve outcomes for patients with inflammatory bowel disease
through treatment at the site of disease in the gastrointestinal
tract, and the BioJet™ systemic oral delivery platform, which is
designed to replace injection for better management of chronic
diseases through needle-free, oral delivery of large molecules.
For more information, visit bioratherapeutics.com or follow the
company on LinkedIn or Twitter.
Safe Harbor Statement or Forward-Looking
Statements
This press release contains “forward-looking statements” within
the meaning of the “safe harbor” provisions of the Private
Securities Litigation Reform Act of 1995, which statements are
subject to substantial risks and uncertainties and are based on
estimates and assumptions. All statements, other than statements of
historical facts included in this press release, including
statements concerning the progress and future expectations and
goals of our research and development, preclinical, and clinical
trial efforts including our phase 1 trial execution and data
timelines, are forward-looking statements. In some cases, you can
identify forward-looking statements by terms such as “may,”
“might,” “will,” “objective,” “intend,” “should,” “could,” “can,”
“would,” “expect,” “forward,” “believe,” “design,” “estimate,”
“predict,” “potential,” “plan,” “target,” or the negative of these
terms, and similar expressions intended to identify forward-looking
statements. These statements reflect our plans, estimates, and
expectations, as of the date of this press release. These
statements involve known and unknown risks, uncertainties and other
factors that could cause our actual results to differ materially
from the forward-looking statements expressed or implied in this
press release. Such risks, uncertainties, and other factors
include, among others, our ability to innovate in the field of
therapeutics, our ability to make future filings and initiate and
execute clinical trials on expected timelines or at all, our
ability to obtain and maintain regulatory approval or clearance of
our products on expected timelines or at all, our plans to
research, develop, and commercialize new products, the
unpredictable relationship between preclinical study results and
clinical study results, our expectations regarding allowed patents
or intended grants to result in issued or granted patents, our
expectations regarding opportunities with current or future
pharmaceutical collaborators or partners, our ability to raise
sufficient capital to achieve our business objectives, and those
risks described in “Risk Factors” and “Management’s Discussion and
Analysis of Financial Condition and Results of Operations” in our
Annual Report on Form 10-K for the year ended December 31, 2022
filed with the SEC and other subsequent documents, including
Quarterly Reports, that we file with the SEC.
Biora Therapeutics expressly disclaims any obligation to update
any forward-looking statements whether as a result of new
information, future events or otherwise, except as required by
law.
Investor ContactChuck PadalaManaging Director,
LifeSci AdvisorsIR@bioratherapeutics.com(646) 627-8390
Media Contactmedia@bioratherapeutics.com
Biora Therapeutics, Inc.Condensed
Consolidated Statements of
Operations(Unaudited)(In
thousands, except share and per share amounts) |
|
|
Three Months Ended |
|
|
December 31,2023 |
|
|
September 30,2023 |
|
Revenues |
$ |
— |
|
|
$ |
— |
|
Operating expenses: |
|
|
|
|
|
Research and development |
|
6,118 |
|
|
|
10,547 |
|
Selling, general and administrative |
|
7,226 |
|
|
|
12,774 |
|
Total operating expenses |
|
13,344 |
|
|
|
23,321 |
|
Loss
from operations |
|
(13,344 |
) |
|
|
(23,321 |
) |
Interest expense, net |
|
(1,840 |
) |
|
|
(2,592 |
) |
Gain on warrant liabilities |
|
12,733 |
|
|
|
4,568 |
|
Other expense, net |
|
(13,276 |
) |
|
|
(52,108 |
) |
Loss before income taxes |
|
(15,727 |
) |
|
|
(73,453 |
) |
Income
tax (benefit) expense |
|
(95 |
) |
|
|
1 |
|
Loss from continuing operations |
|
(15,632 |
) |
|
|
(73,454 |
) |
Gain from discontinued operations |
|
219 |
|
|
|
— |
|
Net loss |
$ |
(15,413 |
) |
|
$ |
(73,454 |
) |
Net loss
per share from continuing operations, basic and diluted |
$ |
(0.63 |
) |
|
$ |
(4.89 |
) |
Net gain
per share from discontinued operations, basic and diluted |
$ |
0.01 |
|
|
$ |
— |
|
Net loss
per share, basic and diluted |
$ |
(0.62 |
) |
|
$ |
(4.89 |
) |
Weighted
average shares outstanding, basic and diluted |
|
24,810,923 |
|
|
|
15,024,726 |
|
|
|
|
|
|
|
|
|
Biora Therapeutics, Inc.Condensed
Consolidated Statements of
Operations(Unaudited)(In
thousands, except share and per share amounts) |
|
|
Three Months
EndedDecember 31, |
|
|
Year Ended December 31, |
|
|
2023 |
|
|
2022 |
|
|
2023 |
|
|
2022 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenues |
$ |
— |
|
|
|
14 |
|
|
$ |
4 |
|
|
$ |
305 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
6,118 |
|
|
|
5,767 |
|
|
|
29,838 |
|
|
|
24,049 |
|
Selling, general and administrative |
|
7,226 |
|
|
|
8,023 |
|
|
|
37,309 |
|
|
|
38,037 |
|
Total operating expenses |
|
13,344 |
|
|
|
13,790 |
|
|
|
67,147 |
|
|
|
62,086 |
|
Loss
from operations |
|
(13,344 |
) |
|
|
(13,776 |
) |
|
|
(67,143 |
) |
|
|
(61,781 |
) |
Interest expense, net |
|
(1,840 |
) |
|
|
(2,685 |
) |
|
|
(9,815 |
) |
|
|
(10,990 |
) |
Gain on warrant liabilities |
|
12,733 |
|
|
|
5,458 |
|
|
|
18,004 |
|
|
|
20,904 |
|
Other (expense) income, net |
|
(13,276 |
) |
|
|
(2,207 |
) |
|
|
(65,470 |
) |
|
|
2,617 |
|
Loss before income taxes |
|
(15,727 |
) |
|
|
(13,210 |
) |
|
|
(124,424 |
) |
|
|
(49,250 |
) |
Income
tax (benefit) expense |
|
(95 |
) |
|
|
259 |
|
|
|
(90 |
) |
|
|
(420 |
) |
Loss from continuing operations |
|
(15,632 |
) |
|
|
(13,469 |
) |
|
|
(124,334 |
) |
|
|
(48,830 |
) |
Gain (loss) from discontinued operations |
|
219 |
|
|
|
(253 |
) |
|
|
219 |
|
|
|
10,673 |
|
Net loss |
$ |
(15,413 |
) |
|
$ |
(13,722 |
) |
|
$ |
(124,115 |
) |
|
$ |
(38,157 |
) |
Net loss
per share from continuing operations, basic and diluted |
$ |
(0.63 |
) |
|
$ |
(1.61 |
) |
|
$ |
(7.88 |
) |
|
$ |
(6.40 |
) |
Net gain
(loss) per share from discontinued operations, basic and
diluted |
$ |
0.01 |
|
|
$ |
(0.03 |
) |
|
$ |
0.01 |
|
|
$ |
1.40 |
|
Net loss
per share, basic and diluted |
$ |
(0.62 |
) |
|
$ |
(1.64 |
) |
|
$ |
(7.87 |
) |
|
$ |
(5.00 |
) |
Weighted
average shares outstanding, basic and diluted |
|
24,810,923 |
|
|
|
8,349,844 |
|
|
|
15,773,297 |
|
|
|
7,635,107 |
|
Biora Therapeutics, Inc.Condensed
Consolidated Balance
Sheets(Unaudited)(In
thousands) |
|
|
December 31, |
|
|
2023 |
|
|
2022 |
|
|
|
|
|
|
|
Assets |
|
|
|
|
|
Current
assets: |
|
|
|
|
|
Cash, cash equivalents and restricted cash |
$ |
15,211 |
|
|
$ |
30,486 |
|
Income tax receivable |
|
830 |
|
|
|
828 |
|
Prepaid expenses and other current assets |
|
3,030 |
|
|
|
4,199 |
|
Current assets of disposal group held for sale |
|
— |
|
|
|
2,603 |
|
Total current assets |
|
19,071 |
|
|
|
38,116 |
|
Property
and equipment, net |
|
1,156 |
|
|
|
1,654 |
|
Right-of-use assets |
|
1,614 |
|
|
|
1,482 |
|
Other
assets |
|
3,302 |
|
|
|
6,201 |
|
Goodwill |
|
6,072 |
|
|
|
6,072 |
|
Total assets |
$ |
31,215 |
|
|
$ |
53,525 |
|
Liabilities and Stockholders' Deficit |
|
|
|
|
|
Current
liabilities: |
|
|
|
|
|
Accounts payable |
$ |
2,843 |
|
|
$ |
3,606 |
|
Accrued expenses and other current liabilities |
|
17,319 |
|
|
|
16,161 |
|
Warrant liabilities |
|
40,834 |
|
|
|
3,538 |
|
Related party senior secured convertible notes, current
portion |
|
1,976 |
|
|
|
— |
|
Total current liabilities |
|
62,972 |
|
|
|
23,305 |
|
Convertible notes, net |
|
9,966 |
|
|
|
127,811 |
|
Senior
secured convertible notes, net |
|
14,591 |
|
|
|
— |
|
Related
party senior secured convertible notes, net |
|
19,179 |
|
|
|
— |
|
Derivative liabilities |
|
22,899 |
|
|
|
— |
|
Other
long-term liabilities |
|
3,029 |
|
|
|
4,696 |
|
Total liabilities |
$ |
132,636 |
|
|
$ |
155,812 |
|
Stockholders' deficit: |
|
|
|
|
|
Common stock |
|
25 |
|
|
|
8 |
|
Additional paid-in capital |
|
868,591 |
|
|
|
743,626 |
|
Accumulated deficit |
|
(950,958 |
) |
|
|
(826,843 |
) |
Treasury stock |
|
(19,079 |
) |
|
|
(19,078 |
) |
Total stockholders' deficit |
|
(101,421 |
) |
|
|
(102,287 |
) |
Total liabilities and stockholders' deficit |
$ |
31,215 |
|
|
$ |
53,525 |
|
|
|
|
|
|
|
|
|
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