Biora Therapeutics, Inc. (Nasdaq: BIOR), the biotech company that
is reimagining therapeutic delivery, today provided a corporate
update and reported financial results for the third quarter ended
September 30, 2023.
“We took a big step in advancing our NaviCap platform toward the
clinic, with the filing of our IND and a planned phase 1 trial for
BT-600 on track for initiation in December,” said Adi Mohanty,
Chief Executive Officer of Biora Therapeutics. “We’re excited about
the NaviCap platform’s potential to improve outcomes for ulcerative
colitis patients who still have significant unmet needs. With our
proprietary technology, we have unique potential to achieve higher
drug levels in the diseased tissue without systemic toxicity,”
continued Mr. Mohanty.
“The third quarter was also marked by accelerating development
of our BioJet™ platform. We progressed our three existing pharma
collaborations during the quarter and are actively negotiating with
a potential fourth pharma collaborator. The BioJet platform has
demonstrated not only category-leading bioavailability, but the
potential to enable liver-targeted, oral delivery of large
molecules,” stated Mr. Mohanty.
Third Quarter 2023 and Other Recent
Highlights
NaviCap™ Targeted Oral Delivery Platform and BT-600 in
ulcerative colitis
- BT-600 IND Filing.
Biora filed an IND application with the FDA for BT-600 in September
2023. The company responded to agency questions and filed an
updated IND in late October to provide additional time for
regulatory review.
- NaviCap Patent for Targeted
Delivery of JAK Inhibitors to the GI Tract. The USPTO
recently allowed a new patent regarding the novel treatment
paradigm of the BT-600 program, which provides targeted delivery of
a JAK inhibitor to the GI tract.
BioJet™ Systemic Oral Delivery Platform preclinical
development
- EASD Presentation of BioJet 2
Data. New data was presented at the European Association
for the Study of Diabetes, demonstrating that the BioJet 2 device
met its performance targets. Across three studies in a porcine
model, 96% of animals showed semaglutide in systemic circulation at
clinically relevant levels, and oral bioavailability averaged
20.5%.
- Liver-Targeted Delivery of
Large Molecules. Early collaborator data indicates the
BioJet platform could provide a unique advantage for
liver-targeted, oral delivery of large molecules through its
proprietary liquid jet injection into the small intestine, where
the hepatic portal system provides optimal delivery to the
liver.
- BioJet Research
Collaborations. Biora received data analysis from animal
studies with one pharma collaborator; completed studies with a
second collaborator and awaits sample analysis; and is initiating
new studies with a third collaborator. Active negotiations are
underway with a fourth potential pharma collaborator.
Capital Markets
- Optimization of Capital
Structure. Biora materially reduced its convertible notes
balance by $50 million through a notes exchange agreement during
the third quarter and raised more than $5.5 million through various
sources including monetization of legacy business assets and direct
capital investments.
Anticipated Milestones
NaviCap™ Targeted Oral Delivery Platform and BT-600 in
ulcerative colitis
- FDA response to IND application for
BT-600 is anticipated, with Phase 1 trial initiation expected
before the end of 2023, followed by execution in Q1 2024, and final
data assessment in Q2 2024
BioJet™ Systemic Oral Delivery Platform development
- Potential new collaboration and
progress with existing collaborators
- Ongoing preclinical data generation
through animal studies with multiple collaborators’ molecules
anticipated during Q4 2024
Third Quarter 2023 Financial Results
Comparison of Three Months Ended September 30, 2023
and June 30, 2023
Operating expenses were $23.3 million for the three months ended
September 30, 2023, compared to $14.9 million for the three
months ended June 30, 2023. The increase 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).
Net loss was $73.5 million and net loss per share was $4.89 for
the three months ended September 30, 2023, compared to a net
loss of $17.8 million and net loss per share of $1.47 for the three
months ended June 30, 2023. This 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.
Comparison of Three Months Ended September 30, 2023
and 2022
Operating expenses were $23.3 million for the three months ended
September 30, 2023, compared to $14.0 million for the three
months ended September 30, 2022. The increase was primarily
attributable to a $9.0 million one-time stock-based compensation
non-cash charge related to vesting of employees' RSUs.
Net loss was $73.5 million and net loss per share was $4.89 for
the three months ended September 30, 2023, compared to a net
loss of $5.1 million and net loss per share of $0.68 for the three
months ended September 30, 2022. This 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 note exchange implemented by the company in September
2023.
Conference Call and Webcast
Information |
Date: |
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Monday, November 13, 2023 |
Time: |
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4:30 PM Eastern time / 1:30 PM Pacific time |
Conference
Call: |
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Domestic 1-877-423-9813International 1-201-689-8573Conference
ID 13741259Call me for instant telephone access |
Webcast: |
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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 and clinical efforts
including phase 1 trial readiness and execution timeline, FDA
acceptance, and trial commencement, 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,” “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
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, 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 |
|
|
|
September 30, 2023 |
|
June 30, 2023 |
|
Revenues |
|
$ |
— |
|
|
$ |
2 |
|
|
Operating
expenses: |
|
|
|
|
|
Research and development |
|
|
10,547 |
|
|
|
5,983 |
|
|
Selling, general and administrative |
|
|
12,774 |
|
|
|
8,953 |
|
|
Total operating expenses |
|
|
23,321 |
|
|
|
14,936 |
|
|
Loss from
operations |
|
|
(23,321 |
) |
|
|
(14,934 |
) |
|
Interest expense, net |
|
|
(2,592 |
) |
|
|
(2,703 |
) |
|
Gain (loss) on warrant liabilities |
|
|
4,568 |
|
|
|
(161 |
) |
|
Other expense, net |
|
|
(52,108 |
) |
|
|
(5 |
) |
|
Loss before income taxes |
|
|
(73,453 |
) |
|
|
(17,803 |
) |
|
Income tax
expense |
|
|
1 |
|
|
|
4 |
|
|
Net loss |
|
$ |
(73,454 |
) |
|
$ |
(17,807 |
) |
|
Net loss per
share, basic and diluted |
|
$ |
(4.89 |
) |
|
$ |
(1.47 |
) |
|
Weighted
average shares outstanding, basic and diluted |
|
|
15,024,726 |
|
|
|
12,143,108 |
|
|
|
|
|
|
|
|
Biora
Therapeutics, Inc.Condensed Consolidated
Statements of
Operations(Unaudited)(In
thousands, except share and per share amounts) |
|
|
|
Three Months Ended September 30, |
|
|
|
|
2023 |
|
|
|
2022 |
|
|
Revenues |
|
$ |
— |
|
|
$ |
80 |
|
|
Operating
expenses: |
|
|
|
|
|
Research and development |
|
|
10,547 |
|
|
|
5,820 |
|
|
Selling, general and administrative |
|
|
12,774 |
|
|
|
8,147 |
|
|
Total operating expenses |
|
|
23,321 |
|
|
|
13,967 |
|
|
Loss from
operations |
|
|
(23,321 |
) |
|
|
(13,887 |
) |
|
Interest expense, net |
|
|
(2,592 |
) |
|
|
(2,773 |
) |
|
Gain on warrant liabilities |
|
|
4,568 |
|
|
|
2,044 |
|
|
Other expense, net |
|
|
(52,108 |
) |
|
|
(100 |
) |
|
Loss before income taxes |
|
|
(73,453 |
) |
|
|
(14,716 |
) |
|
Income tax
expense |
|
|
1 |
|
|
|
158 |
|
|
Loss from continuing operations |
|
|
(73,454 |
) |
|
|
(14,874 |
) |
|
Gain from discontinued operations |
|
|
— |
|
|
|
9,760 |
|
|
Net loss |
|
$ |
(73,454 |
) |
|
$ |
(5,114 |
) |
|
Net loss per
share from continuing operations, basic and diluted |
|
$ |
(4.89 |
) |
|
$ |
(1.99 |
) |
|
Net gain per
share from discontinued operations, basic and diluted |
|
$ |
— |
|
|
$ |
1.30 |
|
|
Net loss per
share, basic and diluted |
|
$ |
(4.89 |
) |
|
$ |
(0.68 |
) |
|
Weighted
average shares outstanding, basic and diluted |
|
|
15,024,726 |
|
|
|
7,478,150 |
|
|
|
|
|
|
|
|
Biora Therapeutics, Inc.Condensed
Consolidated Balance
Sheets(Unaudited)(In
thousands) |
|
|
|
September 30, 2023 |
|
December 31, 2022 |
|
|
|
|
|
|
(1) |
|
|
Assets |
|
|
|
|
|
Current
assets: |
|
|
|
|
|
Cash, cash equivalents and restricted cash |
|
$ |
12,569 |
|
|
$ |
30,486 |
|
|
Income tax receivable |
|
|
818 |
|
|
|
828 |
|
|
Prepaid expenses and other current assets |
|
|
3,351 |
|
|
|
4,199 |
|
|
Current assets of disposal group held for sale |
|
|
2,509 |
|
|
|
2,603 |
|
|
Total current assets |
|
|
19,247 |
|
|
|
38,116 |
|
|
Property and
equipment, net |
|
|
1,236 |
|
|
|
1,654 |
|
|
Right-of-use
assets |
|
|
1,834 |
|
|
|
1,482 |
|
|
Other
assets |
|
|
6,314 |
|
|
|
6,201 |
|
|
Goodwill |
|
|
6,072 |
|
|
|
6,072 |
|
|
Total assets |
|
$ |
34,703 |
|
|
$ |
53,525 |
|
|
Liabilities and Stockholders' Deficit |
|
|
|
|
|
Current
liabilities: |
|
|
|
|
|
Accounts payable |
|
$ |
3,905 |
|
|
$ |
3,606 |
|
|
Accrued expenses and other current liabilities |
|
|
24,314 |
|
|
|
16,161 |
|
|
Warrant liabilities |
|
|
41,325 |
|
|
|
3,538 |
|
|
Total current liabilities |
|
|
69,544 |
|
|
|
23,305 |
|
|
Convertible
notes, net |
|
|
80,378 |
|
|
|
127,811 |
|
|
Other
long-term liabilities |
|
|
3,567 |
|
|
|
4,696 |
|
|
Total liabilities |
|
$ |
153,489 |
|
|
$ |
155,812 |
|
|
Stockholders' deficit: |
|
|
|
|
|
Common stock |
|
|
21 |
|
|
|
8 |
|
|
Additional paid-in capital |
|
|
835,817 |
|
|
|
743,626 |
|
|
Accumulated deficit |
|
|
(935,545 |
) |
|
|
(826,843 |
) |
|
Treasury stock |
|
|
(19,079 |
) |
|
|
(19,078 |
) |
|
Total stockholders' deficit |
|
|
(118,786 |
) |
|
|
(102,287 |
) |
|
Total liabilities and stockholders' deficit |
|
$ |
34,703 |
|
|
$ |
53,525 |
|
|
|
|
|
|
|
|
(1) The condensed consolidated balance sheet data as of December
31, 2022 has been derived from the audited consolidated financial
statements
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