Antibe Reports 2023 Year-End Results and Business Highlights
29 Juin 2023 - 1:30PM
Business Wire
- Completed transition to otenaproxesul’s new
formulation; tablet manufacturing underway - PK/PD study results
expected in calendar Q4 2023 with Phase II initiation in Q1 2024 -
Ended year with $38.9 million in cash and equivalents
Antibe Therapeutics Inc. (TSX: ATE, OTCQX: ATBPF), a
clinical-stage company leveraging its hydrogen sulfide platform to
develop next-generation therapies to target inflammation, has filed
its financial and operating results for the fiscal year ended March
31, 2023.
“We made excellent progress in the year, much of it behind the
scenes,” commented Dan Legault, Antibe’s CEO. “Foremost is the
successful transition to otenaproxesul’s faster-absorbing
formulation, a significant step that involved launching a new
production process in a new plant. With comprehensive liver safety
modeling in hand, we’re making final preparations for a short PK/PD
study to finalize dose selection for the Phase II bunionectomy
trial. We also completed candidate selection and a patent
application filing for our IBD program and identified a new family
of promising anti-inflammatory compounds. With our strong balance
sheet, we’re poised to deliver shareholder value in the coming
year.”
Business Highlights and Operational Update
The following covers fiscal 2023 and subsequent events:
Progress for otenaproxesul on formulation, IP and commercial
potential
- Transitioned to faster-absorbing formulation, including
manufacturing scale up; new formulation accelerates onset of
action, also enabling lower drug doses; patent application filed,
strengthening IP protection to 2043
- Finalized study design and selected CRO for upcoming
pharmacokinetic/pharmacodynamic ("PK/PD") study in healthy
volunteers to confirm the dosing regimens for the Phase II
bunionectomy trial
- Received results from DILIsym, a sophisticated software model
widely used to predict liver safety, suggesting that all envisioned
acute pain treatment regimens of the new formulation are liver-safe
for five-day treatment durations (including a ten day
post-treatment follow up)
- Embarked on a DILIsym program with the new formulation to
explore potential chronic treatment regimens
- Completed third-party commercial assessment, projecting strong
market adoption rates and peak annual sales exceeding US$1 billion
for U.S. market alone; pricing and reimbursement were favorable,
with minimal reimbursement hurdles expected
- Concluded a comprehensive strategic positioning assessment for
acute pain in the U.S. market, identifying a compelling commercial
strategy and validating the drug’s best-in-class positioning in a
market with few novel therapies in development
- Delivered poster presentation at the PAINWeek National
Conference outlining clinical data supporting otenaproxesul’s acute
pain efficacy
Emerging discovery program progressing
- Selected lead and back-up candidates for IBD program, currently
undergoing evaluation in animal efficacy models; filed patent
application, providing protection to 2043
- Selected lead and back-up candidates for a family of new
anti-inflammatory compounds with effectiveness demonstrated in two
animal models; comprehensive announcement expected in the upcoming
quarter
Corporate
- Closed the previously announced sale of Citagenix subsidiary in
an all-cash transaction involving a guaranteed $3.5 million,
divided into four equal payments over three years, with the
remaining $4.0 million subject to Citagenix achieving sales
milestones over four years
- Appointed Robert E. Hoffman as new Board Chair; former Chair,
Walt Macnee, and Antibe’s founder, Dr. John L. Wallace, appointed
as corporate Vice Chairs
- Appointed Scott Curtis to the new position of Chief Operating
Officer; since joining Antibe in 2016, Mr. Curtis has played a
growing role in corporate development and strategic
initiatives
- Completed in-person arbitration proceeding with Nuance Pharma;
decision expected in calendar Q3 2023
Upcoming Milestones
The following summarizes the Company’s estimated timeline for
its key upcoming milestones:
- Complete clinical PK/PD study for otenaproxesul – calendar Q4
2023
- Initiate Phase II bunionectomy trial of otenaproxesul –
calendar Q1 2024
- Deliver Phase II bunionectomy top-line data of otenaproxesul –
calendar Q2 2024
Financial Results
Cash Position: As of March 31, 2023, the Company had
available cash balance and term deposits totaling $38.9 million,
compared to $54.8 million as at March 31, 2022.
Net Loss: For the year ended March 31, 2023, Net Loss and
Comprehensive Loss totaled $19.5 million ($0.37 per share), a
decrease of $5.6 million compared to $25.1 million ($0.50 per
share) in fiscal 2022.
Research and Development Expenses: Research and
development expenses for the year, net of research tax credits,
amounted to $11.3 million, compared to $14.4 million for fiscal
2022.
General and Administrative Expenses: General and
administrative expenses were $6.1 million, compared to $5.4 million
in fiscal 2022.
The Company’s audited fiscal 2023 consolidated financial
statements, MD&A and AIF are available on SEDAR.
About Antibe Therapeutics Inc.
Antibe is a clinical-stage biotechnology company leveraging its
proprietary hydrogen sulfide platform to develop next-generation
therapies to target inflammation arising from a wide range of
medical conditions. The Company’s current pipeline includes assets
that seek to overcome the gastrointestinal (“GI”) ulcers and
bleeding associated with nonsteroidal anti-inflammatory drugs
(“NSAIDs”). Antibe’s lead drug, otenaproxesul, is in clinical
development as a safer alternative to opioids and today’s NSAIDs
for acute pain. Antibe’s second pipeline drug, ATB-352, is being
developed for a specialized pain indication. The Company’s next
target is inflammatory bowel disease (“IBD”), a condition long in
need of safer, more effective therapies. Learn more at
antibethera.com.
Forward Looking Information
This news release includes certain forward-looking statements
under applicable securities laws, which may include, but are not
limited to, the amounts, timing and receipt of the portion of the
Citagenix sale price that is subject to the achievement of sales
milestones, the anticipated scope, timing, duration and completion
of certain of the Company’s clinical trial programs and studies and
the anticipated timing for seeking market approval for certain of
the Company’s drugs and therapies for certain additional
indications. Any statements contained herein that are not
statements of historical facts may be deemed to be forward-looking,
including those identified by the expressions “will”, “anticipate”,
“believe”, “plan”, “estimate”, “expect”, “intend”, “propose” and
similar wording. Forward-looking statements involve known and
unknown risks and uncertainties that could cause actual results,
performance, or achievements to differ materially from those
expressed or implied in this news release. Factors that could cause
actual results to differ materially from those anticipated in this
news release include, but are not limited to, Citagenix not
achieving sales milestones, the Company’s inability to timely
execute on its business strategy and timely and successfully
complete its clinical trials and studies, the Company’s inability
to obtain the necessary regulatory approvals related to its
activities, risks associated with drug and medical device
development generally and those risk factors set forth in the
Company’s public filings made in Canada and available on sedar.com.
The Company assumes no obligation to update the forward-looking
statements or to update the reasons why actual results could differ
from those reflected in the forward-looking statements except as
required by applicable law.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20230629703637/en/
Antibe Therapeutics Inc. Christina Cameron VP Investor Relations
+1 416-577-1443 christina@antibethera.com
Antibe Therapeutics (TSX:ATE)
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