Acrivon Therapeutics Reports Third Quarter 2023 Financial Results and Business Highlights
09 Novembre 2023 - 2:01PM
Acrivon Therapeutics, Inc. (“Acrivon” or “Acrivon Therapeutics”)
(Nasdaq: ACRV), a clinical stage biopharmaceutical company
developing precision oncology medicines that it matches to patients
whose tumors are predicted to be sensitive to each specific
medicine by utilizing its proprietary proteomics-based patient
responder identification platform, today reported financial results
for the third quarter ended September 30, 2023 and provided
business highlights.
“Acrivon remains committed to being science and data-driven as
we continue advancing our clinical and preclinical pipeline of
precision oncology medicines, enabled by our highly differentiated
Acrivon Predictive Precision Proteomics (AP3) platform,” said Peter
Blume-Jensen, M.D., Ph.D., chief executive officer, president, and
founder of Acrivon. “Our recent presentations at the AACR-NCI-EORTC
International Conference on Molecular Targets and Cancer
Therapeutics further demonstrate the unique and broad capabilities
of AP3 and our drug-specific OncoSignature assays. As part of our
third quarter highlights, we are also pleased to provide initial
clinical readouts for ACR-368 and plan to present more mature data
at a major medical conference during the first half of 2024. We are
also very excited about the advancement of our novel,
internally-discovered development candidate ACR-2316, a dual
WEE1/PKMYT1 inhibitor specifically designed by AP3 for superior,
single agent activity, as demonstrated in preclinical studies
compared to benchmark clinical compounds. We plan to submit an IND
for ACR-2316 in the fourth quarter of 2024.”
Recent Highlights
- Continued enrollment of patients in
the multicenter, registrational-intent Phase 2 study based on
OncoSignature-predicted sensitivity to ACR-368 in patients with
locally advanced or metastatic, recurrent platinum-resistant
ovarian cancer, as well as endometrial adenocarcinoma or urothelial
cancer, two tumor types predicted to be sensitive to ACR-368
through OncoSignature screening and not previously evaluated in
past clinical trials. Initial clinical observations are encouraging
and support the ongoing trials.
- Consistent with the overall
favorable tolerability profile previously observed in multiple past
single-arm trials conducted at recommended Phase 2 dose (RP2D),
drug-related adverse events were primarily hematological,
reversible, and manageable
- In the limited number of patients
evaluated by imaging to date, preliminary evidence of clinical
activity was observed in OncoSignature-positive patients across all
three tumor types treated with single agent ACR-368 at RP2D
- Consistent with AP3-predicted tumor
sensitivity to the combination of ACR-368 and low dose gemcitabine
(LDG) in OncoSignature-negative patients, early imaging-based
evidence of clinical activity across all three tumor types was also
observed in patients treated with ACR-368 at RP2D and LDG during
the dose escalation phase
- Presentation of two posters
demonstrating the broader capabilities of the AP3 platform,
including unbiased characterization of clinically actionable
ACR-368-induced phosphoproteome alterations and extensive
evaluation of the ACR-368 OncoSignature assay for patient responder
identification at the AACR-NCI-EORTC International Conference on
Molecular Targets and Cancer Therapeutics
- The poster titled “Identification of
Biomarkers Predictive of Sensitivity to the CHK1/2 Inhibitor
ACR-368 Using High-Resolution Phosphoproteomics and Development of
an ACR-368-Tailored Patient Responder Identification 3-Marker Test,
ACR-368 OncoSignature” showed data leveraging the company’s AP3
approach, including ultra-high resolution, quantitative mass
spectrometry-based phosphoproteomics profiling combined with
proprietary approaches to identify three classes of functionally
orthogonal candidate biomarkers specifically predictive of
sensitivity to ACR-368. The company’s ACR-368-specific
OncoSignature assay accurately predicted sensitivity to ACR-368 in
genetically non-modified ovarian cancer patient-derived xenograft
(PDX) models with an area under the curve (AUC) of 0.9 (95%
confidence interval: 0.71 to 1; p-value = 0.025). These data
support the use of the company’s ACR-368 OncoSignature assay in its
ongoing registrational-intent Phase 2 clinical trials, and
demonstrate the distinctive, practical application of the company’s
AP3 platform.
- The poster titled “Validation of the
OncoSignature Assay, an ACR-368-Tailored Response-Predictive
Quantitative Multiplexed Immunofluorescent Assay for Prediction of
Sensitivity to the CHK1/2 Inhibitor ACR-368 in Individual Patients
with Cancer” provided data validating the ability of the
AP3-derived ACR-368-specific OncoSignature assay to predict tumor
response to ACR-368 in multiple blinded, prospectively-designed
preclinical studies, including two separate studies on pretreatment
tumor biopsies from past Phase 2 clinical trials in patients with
ovarian cancer and in tumor types predicted sensitive to ACR-368,
including endometrial cancer. In the two pretreatment tumor biopsy
studies, the ACR-368 OncoSignature test was overall able to
segregate responders from non-responders with high accuracy and
enrich for responders, achieving an overall response rate of 47%
and 58% with strong statistical significance. Additionally,
endometrial and bladder cancers were identified as new tumor types
predicted sensitive to ACR-368 in 30-40% of cases.
- Continued advancement of
IND-enabling studies for ACR-2316, the company’s internally
discovered, selective dual WEE1 and PKMYT1 inhibitor, specifically
designed using the AP3 platform and rational drug design based on
co-crystallography to achieve potent single agent activity. The
company anticipates IND submission in the fourth quarter of 2024
and plans to then initiate clinical monotherapy development in
tumor types predicted sensitive to ACR-2316 through ongoing
AP3-based indication finding and subsequent treatment of patients
based on OncoSignature-predicted sensitivity.
Anticipated Upcoming Milestones
- Company plans to present more
mature clinical data from the ongoing Phase 2 ACR-368 monotherapy
single-arm trials and the Phase 1b/2 ACR-368 and LDG combination
single-arm trials at a major medical conference during the first
half of 2024
- Completion of IND-enabling studies
for ACR-2316 to support IND submission for this novel drug
candidate in the fourth quarter of 2024
Third Quarter 2023 Financial Results
Net loss for the quarter ended September 30, 2023 was $14.5
million compared to a net loss of $9.2 million for the same period
in 2022.
Research and development expenses were $10.3 million for the
quarter ended September 30, 2023 compared to $7.9 million for the
same period in 2022. The difference was primarily due to the
continued development of ACR-368, inclusive of progression of the
ongoing clinical trial, as well as increased personnel costs to
support these development activities and costs associated with our
preclinical programs, including ACR-2316.
General and administrative expenses were $5.9 million for the
quarter ended September 30, 2023 compared to $1.6 million for the
same period in 2022. The difference was primarily due to the
increased cost of operating as a public company, inclusive of
increased personnel costs and non-cash stock compensation
expense.
As of September 30, 2023, the company had cash, cash equivalents
and marketable securities of $142.1 million, which is expected to
fund operations into the second half of 2025.
About Acrivon Therapeutics
Acrivon is a clinical stage biopharmaceutical
company developing precision oncology medicines that it matches to
patients whose tumors are predicted to be sensitive to each
specific medicine by utilizing Acrivon’s proprietary
proteomics-based patient responder identification platform, Acrivon
Predictive Precision Proteomics, or AP3. The AP3 platform is
engineered to measure compound-specific effects on the entire tumor
cell protein signaling network and drug-induced resistance
mechanisms in an unbiased manner. These distinctive capabilities
enable AP3’s direct application for drug design optimization for
monotherapy activity, the identification of rational drug
combinations, and the creation of drug-specific proprietary
OncoSignature companion diagnostics that are used to identify the
patients most likely to benefit from Acrivon’s drug candidates.
Acrivon is currently advancing its lead candidate, ACR-368, a
selective small molecule inhibitor targeting CHK1 and CHK2 in a
potentially registrational Phase 2 trial across multiple tumor
types. The company has received Fast Track designation from the
Food and Drug Administration, or FDA, for the investigation of
ACR-368 as monotherapy based on OncoSignature-predicted sensitivity
in patients with platinum-resistant ovarian or endometrial cancer.
Acrivon’s ACR-368 OncoSignature test, which has not yet obtained
regulatory approval, has been extensively evaluated in preclinical
studies, including in two separate, blinded, prospectively-designed
studies on pretreatment tumor biopsies collected from past
third-party Phase 2 trials in patients with ovarian cancer treated
with ACR-368. In addition to ACR-368, Acrivon is also leveraging
its proprietary AP3 precision medicine platform for developing its
internally-discovered preclinical stage pipeline programs,
consisting of its development candidate, ACR-2316, a selective,
dual WEE1/PKMYT1 inhibitor, and additional programs targeting these
two critical nodes in the DNA Damage Response, or DDR,
pathways.
Forward-Looking Statements
This press release includes certain disclosures that contain
“forward-looking statements” within the meaning of the Private
Securities Litigation Reform Act of 1995 about us and our industry
that involve substantial risks and uncertainties. All statements
other than statements of historical facts contained in this press
release, including statements regarding our future results of
operations or financial condition, business strategy and plans and
objectives of management for future operations, are forward-looking
statements. In some cases, you can identify forward-looking
statements because they contain words such as “anticipate,”
“believe,” “contemplate,” “continue,” “could,” “estimate,”
“expect,” “intend,” “may,” “plan,” “potential,” “predict,”
“project,” “should,” “target,” “will,” or “would” or the negative
of these words or other similar terms or expressions.
Forward-looking statements are based on Acrivon’s current
expectations and are subject to inherent uncertainties, risks and
assumptions that are difficult to predict. Factors that could cause
actual results to differ include, but are not limited to, risks and
uncertainties that are described more fully in the section titled
“Risk Factors” in our reports filed with the Securities and
Exchange Commission. Forward-looking statements contained in this
press release are made as of this date, and Acrivon undertakes no
duty to update such information except as required under applicable
law.
Investor and Media Contacts: Adam D. Levy,
Ph.D., M.B.Aalevy@acrivon.com
Alexandra Santos asantos@wheelhouselsa.com
Acrivon
Therapeutics, Inc. Condensed Consolidated Statements of Operations
and Comprehensive Loss (unaudited, in thousands, except
share and per share data) |
|
|
|
Three Months Ended September 30, |
|
Nine Months Ended September 30, |
|
|
|
|
|
2023 |
|
|
|
2022 |
|
|
|
2023 |
|
|
|
2022 |
|
|
|
Operating
expenses: |
|
|
|
|
|
|
|
|
|
|
Research and development |
|
$ |
10,267 |
|
|
$ |
7,942 |
|
|
$ |
30,546 |
|
|
$ |
18,087 |
|
|
|
General and administrative |
|
|
5,870 |
|
|
|
1,633 |
|
|
|
15,504 |
|
|
|
4,625 |
|
|
|
Total operating expenses |
|
|
16,137 |
|
|
|
9,575 |
|
|
|
46,050 |
|
|
|
22,712 |
|
|
|
Loss from
operations |
|
|
(16,137 |
) |
|
|
(9,575 |
) |
|
|
(46,050 |
) |
|
|
(22,712 |
) |
|
|
Other income
(expense): |
|
|
|
|
|
|
|
|
|
|
Other income, net |
|
|
1,671 |
|
|
|
377 |
|
|
|
4,914 |
|
|
|
474 |
|
|
|
Total other income, net |
|
|
1,671 |
|
|
|
377 |
|
|
|
4,914 |
|
|
|
474 |
|
|
|
Net
loss |
|
$ |
(14,466 |
) |
|
$ |
(9,198 |
) |
|
$ |
(41,136 |
) |
|
$ |
(22,238 |
) |
|
|
Net loss per
share - basic and diluted |
|
$ |
(0.66 |
) |
|
$ |
(5.17 |
) |
|
$ |
(1.87 |
) |
|
$ |
(12.55 |
) |
|
|
Weighted-average common stock outstanding - basic and diluted |
|
22,081,162 |
|
|
|
1,778,255 |
|
|
|
21,991,509 |
|
|
|
1,772,491 |
|
|
|
Comprehensive loss: |
|
|
|
|
|
|
|
|
|
|
Net
loss |
|
$ |
(14,466 |
) |
|
$ |
(9,198 |
) |
|
$ |
(41,136 |
) |
|
$ |
(22,238 |
) |
|
|
Other
comprehensive loss: |
|
|
|
|
|
|
|
|
|
|
Unrealized gain (loss) on available-for-sale investments, net of
tax |
|
|
125 |
|
|
|
(133 |
) |
|
|
(207 |
) |
|
|
(133 |
) |
|
|
Comprehensive loss |
|
$ |
(14,341 |
) |
|
$ |
(9,331 |
) |
|
$ |
(41,343 |
) |
|
$ |
(22,371 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
Acrivon Therapeutics, Inc. Condensed Consolidated
Balance Sheets(unaudited, in thousands) |
|
|
|
September 30, 2023 |
|
December 31, 2022 |
|
Assets |
|
|
|
|
|
Cash and cash equivalents |
|
$ |
29,859 |
|
$ |
29,519 |
|
Short-term investments |
|
|
112,231 |
|
|
98,232 |
|
Long-term investments |
|
|
- |
|
|
41,881 |
|
Other assets |
|
|
9,002 |
|
|
11,594 |
|
Total assets |
|
$ |
151,092 |
|
$ |
181,226 |
|
Liabilities and Stockholders' Equity |
|
|
|
|
|
Liabilities |
|
|
12,943 |
|
|
10,751 |
|
Stockholders' Equity |
|
|
138,149 |
|
|
170,475 |
|
Total Liabilities and Stockholders' Equity |
$ |
151,092 |
|
$ |
181,226 |
|
|
|
|
|
|
Grafico Azioni Acrivon Therapeutics (NASDAQ:ACRV)
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