Presented Final Data from Phase 1b/2 Trial of
AU-011 in Choroidal Melanoma at the American Academy of
Ophthalmology’s Annual Meeting
Completed Initial Public Offering to Fund
Pivotal Program for AU-011 in Choroidal Melanoma and Earlier Stage
Oncology Pipeline
Aura Biosciences Inc. (NASDAQ: AURA), a clinical-stage
biotechnology company developing a novel class of virus-like drug
conjugate (VDC) therapies for multiple oncology indications
including ocular and urologic cancers, today announced financial
results for the third quarter ended September 30, 2021.
“We recently completed a successful initial public offering,
placing us in a solid financial position to advance our lead VDC,
AU-011, through pivotal development for our first indication in the
ocular oncology franchise,” said Elisabet de los Pinos, Ph.D.,
Chief Executive Officer of Aura. “We are very encouraged with the
final data from the Phase 1b/2 trial with intravitreal
administration that was presented by Dr. Carol Shields at the AAO
annual meeting last week, as well as the continued favorable safety
and tolerability profile of the ongoing Phase 2 study with
suprachoroidal administration. These data support our plan to move
into the pivotal program in 2022 with the goal to develop the first
targeted therapy for patients with indeterminate lesions and small
choroidal melanoma.
Dr. Pinos continued: “We are also excited to work toward
unlocking the broad oncology potential of the VDC platform and plan
to initiate clinical development in non-muscle invasive bladder
cancer during the second half of next year. Supporting the
advancement of our programs, we have a robust balance sheet and a
strong team, which we recently built out with several key additions
to our management team and Board of Directors.”
Recent Pipeline Developments
- AU-011 is being developed for the first line treatment of
indeterminate lesions and small choroidal melanoma, a life
threatening and rare disease with no approved drugs. Data from two
clinical trials were recently presented at the American Academy of
Ophthalmology (AAO) 2021 Annual Meeting.
- Final Phase 1b/2 Data with Intravitreal (IVT)
Administration. Data from the completed Phase 1b/2 trial using
IVT administration were presented by Dr. Carol Shields, Director,
Ocular Oncology Service at Wills Eye Hospital and Professor of
Ophthalmology at Thomas Jefferson University. The data demonstrated
a statistically significant reduction in tumor growth rate (-0.483
mm/yr, p = 0.018), a 64% tumor control rate, and a visual acuity
preservation rate of 71%, which is a dramatic improvement compared
to the current standard of care with radiotherapy. These three
endpoints have been agreed upon with FDA and will be used in the
pivotal program.
- Interim Phase 2 Safety Data with Suprachoroidal (SC)
Administration. Preliminary results presented by Dr. Hakan
Demirci, Professor of Ophthalmology at Kellogg Eye Center,
University of Michigan, demonstrate a favorable safety and
tolerability profile for AU-011 with SC administration. The data
showed no treatment-related serious adverse events, dose limiting
toxicities, or grade 3/4 adverse events. Aura plans to present 6-12
months safety and efficacy data from this trial in 2022.
- Aura plans to select the route of administration and treatment
regimen to initiate the pivotal program in the second half of
2022.
- Leveraging the broad tumor targeting capabilities of the VDC
platform, Aura is planning to pursue clinical development of AU-011
in non-muscle invasive bladder cancer (NMIBC).
- NMIBC is an area of high unmet need with no approved targeted
therapies. The AU-011 mechanism of action supports the opportunity
for use as a first-line treatment either following initial
diagnosis and/or Bacillus Calmette-Guerin, BCG, refractory disease.
The data from preclinical Investigational New Drug (IND)-enabling
studies of AU-011 demonstrated robust efficacy, supporting its
clinical development as a single agent or in combination with
checkpoint inhibitors. The planned Phase 1a trial will evaluate the
safety and early proof of mechanism in the setting, exploring local
necrosis and evidence of immune activation, and Aura expects to
initiate the trial in the second half of 2022.
Recent Corporate Updates
- Completed Initial Public Offering (IPO). In November
2021, Aura closed a successful IPO of 6,210,000 shares of its
common stock, which included the full exercise of the underwriters’
option, at a public offering price of $14.00 per share. The
aggregate gross proceeds to Aura from the IPO were approximately
$86.9 million, before deducting underwriting discounts and
commissions and other estimated offering expenses. Aura’s common
stock commenced trading on the Nasdaq Global Market on October 29,
2021 under the ticker symbol “AURA”.
- Antony Mattessich Appointed to the Board of Directors in
September 2021. Mr. Mattessich is currently the Chief Executive
Officer at Ocular Therapeutix. Prior to Ocular Therapeutix, he was
Managing Director of Mundipharma International, based in Cambridge,
England. Prior to his time at Mundipharma, Mr. Mattessich ran the
U.S. respiratory, dermatology and pediatrics group at
Novartis.
- Chris Primiano, J.D., Appointed Chief Business Officer in
September 2021. Mr. Primiano joined Aura from Karyopharm
Therapeutics Inc., where he most recently served as Executive Vice
President, Chief Business Officer, General Counsel and Secretary.
Mr. Primiano played an important role in transitioning Karyopharm
Therapeutics Inc. from 40 employees in a preclinical and early
clinical development setting to 400 employees, commercializing
XPOVIO® (selinexor) across multiple indications.
Third Quarter 2021 Financial Results
- As of September 30, 2021, Aura had cash and cash equivalents
totaling $81.8 million. Aura raised $86.9 million in gross proceeds
from the IPO. Aura believes its current cash and cash equivalents
are sufficient to fund the Company’s operations into 2024.
- Research and development expenses increased to $6.4 million for
the three months ended September 30, 2021 from $2.9 million for the
three months ended September 30, 2020, primarily due to progression
of clinical trials and ongoing manufacturing development costs for
AU-011. In addition, research and development expenses related to
personnel increased from growing headcount due to the progression
of clinical trials.
- General and administrative expenses increased to $2.5 million
for the three months ended September 30, 2021 from $0.8 million for
the three months ended September 30, 2020. General and
administrative expenses include $0.4 million and $0.1 million of
stock-based compensation for the three months ended September 30,
2021 and 2020, respectively. The increase was primarily related to
an increase in personnel expenses due to an increase in headcount,
as well as general increases in audit, legal, consulting and
facilities expenses in anticipation of becoming a public
company.
- Net loss for the three months ended September 30, 2021, was
$8.8 million, compared to $3.6 million for the three months ended
September 30, 2020.
About Aura Biosciences
Aura Biosciences, Inc. is a clinical-stage biotechnology company
developing a novel class of virus-like drug conjugate (VDC)
therapies for multiple oncology indications including ocular and
urologic cancers. Aura’s technology utilizes VDCs to target and
destroy cancer cells selectively while activating the immune system
to create long lasting anti-tumor immunity. The company has the
goal of developing this technology in multiple cancer indications
with an initial focus in ocular oncology, life-threatening eye
cancers, the majority of which have no approved drugs available for
treatment. Aura’s lead product candidate belzupacap sarotalocan
(AU-011) is currently in Phase 2 development for the first line
treatment of indeterminate lesions and small choroidal melanoma, a
vision- and life-threatening form of eye cancer where standard of
care radioactive treatment leaves patients with major vision loss
and severe comorbidities. AU-011 was well tolerated in a Phase 1b/2
trial, demonstrating a statistically significant growth rate
reduction in patients with prior active growth and high levels of
tumor control with visual acuity preservation in a majority of
patients. We believe these data provide the potential to introduce
a new standard of care in choroidal melanoma and treat patients
with early-identified lesions for whom no treatments are currently
available. Future clinical development for AU-011 is planned
throughout ocular oncology, including in choroidal metastases where
Aura expects to file an IND during the second half of 2022. The
unique mechanism of action of Aura’s HSPG-targeting VDCs also
enables development of AU-011 as a platform broadly across multiple
solid tumors; the first clinical trial of AU-011 outside ocular
oncology is planned for the second half of 2022 in non-muscle
invasive bladder cancer, a high unmet medical need where patients
have poor treatment options and tumor progression leads to
cystectomy (bladder removal) and a high risk of metastases. Future
pipeline growth is expected to include additional drug conjugates
for broad oncology applications. Aura is headquartered in
Cambridge, MA.
Forward Looking Statement
This press release may contain forward-looking statements and
information within the meaning of The Private Securities Litigation
Reform Act of 1995 and other federal securities laws. Any
statements that are not statements of historical fact may be deemed
to be forward looking statements. Words such as “may,” “will,”
“could”, “should,” “expects,” “intends,” “plans,” “anticipates,”
“believes,” “estimates,” “predicts,” “projects,” “seeks,”
“endeavor,” “potential,” “continue” or the negative of such words
or other similar expressions that can be used to identify
forward-looking statements. These forward looking statements
include express or implied statements regarding Aura’s future
expectations, plans and prospects, including, without limitation,
statements regarding expectations and plans for presenting clinical
data, including of Phase 2 safety and efficacy data of AU-011 in SC
administration, projections regarding Aura’s long-term growth,
including having a cash runway into 2024, the anticipated timing of
Aura’s clinical trials and regulatory filings, including for
initiation of a pivotal program of AU-011 in indeterminate lesions
and choroidal melanoma and of a Phase 1a trial of AU-011 in
non-muscle invasive bladder cancer, the development of Aura’s
product candidates and advancement of Aura’s clinical programs.
The express or implied forward-looking statements included in
this press release are only predictions and are subject to a number
of risks, uncertainties and assumptions, including, without
limitation: uncertainties inherent in clinical trials and in the
availability and timing of data from ongoing clinical trials;
whether interim results from a clinical trial, including the Phase
2 SC administration trial, will be predictive of the final results
of the trial; whether results from pre-clinical studies or earlier
clinical studies will be predictive of the results of future
trials, including regarding AU-011’s ability to offer vision
preserving therapy for the first line treatment of choroidal
melanoma; the expected timing of the expansion phase of the Phase 2
SC administration trial; the expected timing for submissions for
regulatory approval or review by governmental authorities; whether
Aura will receive regulatory approvals to conduct trials or to
market products; whether Aura’s cash resources will be sufficient
to fund its foreseeable and unforeseeable operating expenses and
capital expenditure requirements; risks, assumptions and
uncertainties regarding the impact of the continuing COVID-19
pandemic on Aura’s business, operations, strategy, goals and
anticipated timelines; Aura’s ongoing and planned pre-clinical
activities; Aura’s ability to initiate, enroll, conduct or complete
ongoing and planned clinical trials, Aura’s timelines for
regulatory submissions; and Aura’s financial position. These and
other risks and uncertainties are described more fully in the
section titled “Risk Factors” set forth in Aura’s filings with the
Securities and Exchange Commission. In light of these risks,
uncertainties and assumptions, the forward-looking events and
circumstances discussed in this press release may not occur and
actual results could differ materially and adversely from those
anticipated or implied in the forward-looking statements. You
should not rely upon forward-looking statements as predictions of
future events. Although Aura believes that the expectations
reflected in the forward-looking statements are reasonable, it
cannot guarantee that the future results, levels of activity,
performance or events and circumstances reflected in the
forward-looking statements will be achieved or occur. Moreover,
except as required by law, neither Aura nor any other person
assumes responsibility for the accuracy and completeness of the
forward-looking statements included in this press release. Any
forward-looking statement included in this press release speaks
only as of the date on which it was made. Aura undertakes no
obligation to publicly update or revise any forward-looking
statement, whether as a result of new information, future events or
otherwise, except as required by law.
Aura Biosciences, Inc.
Condensed Statement of Operations (in thousands, except share and
per share amounts)
Three Months Ended September
30,
Nine Months Ended September
30,
2021
2020
2021
2020
Operating Expenses:
Research and development
$
6,365
$
2,850
$
17,182
$
14,499
General and administrative
2,530
781
6,441
2,798
Total operating expenses
8,895
3,631
23,623
17,297
Total operating loss
8,895
3,631
23,623
17,297
Other income (expense):
Change in fair value of warrant
liability
-
-
1
-
Change in fair value of derivative
liability
52
-
-
-
Interest income (expense), including
amortization of discount
5
-
8
(2)
Loss from disposal of assets
-
-
(3)
-
Total other income (expense)
57
-
6
(2)
Net loss and comprehensive loss
$
(8,838)
$
(3,631)
$
(23,617)
$
(17,299)
Net loss attributable to common
stockholders— basic and diluted
$
(12,506)
$
(5,579)
$
(33,244)
$
(23,101)
Net loss per share attributable to common
stockholders— basic and diluted
(28.33)
(14.81)
(77.93)
(63.69)
Weighted average common stock outstanding—
basic and diluted
441,448
376,738
426,604
362,735
Aura Biosciences, Inc.
Condensed Balance Sheets (in thousands, except share and per share
amounts)
As of
September 30, 2021
December 31, 2020
Assets
Current assets:
Cash and cash equivalents
$
81,829
$
17,393
Restricted cash and deposits
20
19
Prepaid expenses and other current
assets
1,609
1,043
Total current assets
83,458
18,455
Restricted cash and deposits, net of
current portion
125
75
Right of use assets - operating lease
1,096
-
Property and equipment, net
4,442
3,574
Deferred offering costs
1,583
-
Total Assets
$
90,704
$
22,104
Liabilities, Convertible Preferred
Stock, and Stockholders’ Deficit
Current liabilities:
Accounts payable
1,736
611
Current portion of operating lease
liabilities
607
-
Accrued expenses and other current
liabilities
3,488
2,050
Total current liabilities
5,831
2,661
Deferred rent
-
8
Operating lease liabilities, net of
current portion
513
-
Warrant liability
71
72
Total Liabilities
6,415
2,741
Commitments and Contingencies (Note
12)
Series A convertible preferred stock,
$0.00001 par value, 1,701,141 shares authorized, issued and
outstanding at September 30, 2021 and December 31, 2020,
respectively, and a liquidation preference of $3,403 at September
30, 2021 and December 31, 2020, respectively
3,368
3,368
Series A-1 convertible preferred stock,
$0.00001 par value, 3,298,732 shares authorized, issued, and
outstanding at September 30, 2021 and December 31, 2020,
respectively, and a liquidation preference of $8,196 at September
30, 2021 and December 31, 2020, respectively
7,837
7,837
Series A-2 convertible preferred stock,
$0.00001 par value, 4,325,021 shares authorized, and 4,324,998
shares issued and outstanding at September 30, 2021 and December
31, 2020, respectively, and a liquidation preference of $5,373 at
September 30, 2021 and December 31, 2020, respectively
5,373
5,373
Series B convertible preferred stock,
$0.00001 par value, 22,705,646 shares authorized, and 22,531,819
shares issued and outstanding at September 30, 2021 and December
31, 2020, respectively, and a liquidation preference of $38,894 and
$37,429 at September 30, 2021 and December 31, 2020,
respectively
20,806
20,806
Series C-1 convertible preferred stock,
$0.00001 par value, 58,109,711 shares authorized, issued and
outstanding at September 30, 2021 and December 31, 2020,
respectively, and a liquidation preference of $37,736 and $36,150
at September 30, 2021 and December 31, 2020, respectively
29,353
29,353
Series C-2 convertible preferred stock,
$0.00001 par value, 33,218,192 shares authorized, issued and
outstanding at September 30, 2021 and December 31, 2020,
respectively, and a liquidation preference of $15,332 and $14,697
at September 30, 2021 and December 31, 2020, respectively
11,746
11,746
Series D-1 convertible preferred stock,
$0.00001 par value, 57,878,742 shares authorized, issued and
outstanding at September 30, 2021 and December 31, 2020,
respectively, and a liquidation preference of $46,003 and $43,908
at September 30, 2021 and December 31, 2020, respectively
39,686
39,686
Series D-2 convertible preferred stock,
$0.00001 par value, 24,598,481 shares authorized, and 24,598,481
and 14,469,710 issued and outstanding at September 30, 2021 and
December 31, 2020, respectively, and a liquidation preference of
$17,982 and $10,176 at September 30, 2021 and December 31, 2020,
respectively
16,889
9,907
Series E convertible preferred stock,
$0.00001 par value, 102,671,041 shares authorized, issued and
outstanding at September 30, 2021, and a liquidation preference of
$83,525 at September 30, 2021; no shares authorized, issued or
outstanding at December 31, 2020, respectively
80,246
-
Stockholders’ Deficit:
Common stock, $0.00001 par value,
470,183,383 and 232,697,999 authorized at September 30, 2021 and
December 31, 2020, and 442,717 and 381,123 shares issued and
outstanding at September 30, 2021 and December 31, 2020,
respectively
-
-
Additional paid-in capital
9,488
8,173
Accumulated deficit
(140,503)
(116,886)
Total Stockholders’ Deficit
(131,015)
(108,713)
Total Liabilities, Convertible
Preferred Stock, and Stockholders’ Deficit
$
90,704
$
22,104
View source
version on businesswire.com: https://www.businesswire.com/news/home/20211124006204/en/
Investor and Media Contact: Matthew DeYoung Argot
Partners 212-600-1902 | aura@argotpartners.com
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