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 second quarter ended June 30, 2023 and provided business
highlights.
“The Acrivon team has made significant progress during the
second quarter, both on the clinical and preclinical development
fronts, as well as with the expansion of our board and executive
leadership team with strategic additions,” said Peter Blume-Jensen,
M.D., Ph.D., chief executive officer, president, and founder of
Acrivon. “We are delighted to welcome Chuck Baum to our board and
Adam Levy as our head of investor relations and corporate affairs.
They both share the passion for our vision to revolutionize
precision medicine with our proteomics-based AP3 patient selection
platform, including our proprietary drug-specific OncoSignature
test, a first-of-its-kind companion diagnostic to identify patients
likely to respond to treatment. We remain focused on the successful
execution of our ongoing registrational-intent Phase 2 study of
ACR-368, our potentially first-in-class CHK1/2 inhibitor, in
patients with platinum-resistant ovarian cancer, endometrial
adenocarcinoma, and urothelial cancers, based on predicted
sensitivity using our OncoSignature test. We look forward to
sharing initial clinical data on this clinical study later in the
second half of this year. Based on previously reported data that
ACR-368 induced deep and durable responses in a proportion of
patients with platinum-resistant ovarian cancer and squamous cell
cancers, as well as prospectively-designed, blinded preclinical
studies using pretreatment tumor biopsies and patient-derived
xenograft models to demonstrate the ability of OncoSignature to
enrich for responders, we are energized by the significant
potential we have to transform the cancer treatment landscape for
patients. As a further example of the broad and actionable utility
of our AP3 platform, we are also using it together with
co-crystallography for optimal drug design to rapidly advance our
preclinical pipeline against two critical cell cycle targets, WEE1
and PKMYT1, and are on track for development candidate nomination
and the initiation of IND-enabling studies in the second half of
this year.”
Recent Highlights
- Continued to expand key scientific capabilities in areas like
data science and augmented the board of directors and executive
team with two seasoned biopharma leaders
- Appointed Charles (Chuck) Baum, M.D., Ph.D., to the board of
directors. Dr. Baum brings over 30 years of senior executive
expertise, including as a precision oncology drug developer who led
or significantly contributed to the development of six approved
medicines
- Appointed Adam Levy, Ph.D., M.B.A., as senior vice president
and head of investor relations and corporate affairs. Dr. Levy
brings 25 years of industry experience with proven leadership in
investor relations and corporate strategy
- Continued to enroll patients in a multicenter,
registrational-intent Phase 2 study based on
OncoSignature-predicted sensitivity to ACR-368 (also known as
prexasertib), a selective small molecule inhibitor targeting CHK1
and CHK2
- Patients with locally advanced or metastatic, recurrent
platinum-resistant ovarian cancer, endometrial adenocarcinoma, or
urothelial cancers are eligible
- Approximately 40 clinical sites now activated in the U.S. with
additional sites expected to be added on an ongoing basis
- Granted two Fast Track designations by the U.S. Food and Drug
Administration for the development of ACR-368 for patients with
OncoSignature-positive platinum-resistant ovarian cancer and
endometrial cancer
- Continued to advance multiple lead series for our two pipeline
programs targeting critical nodes in the DNA Damage Response and
cell cycle regulation pathways based on Acrivon Predictive
Precision Proteomics (AP3) profiling and co-crystallography
- WEE1, a protein serine/threonine kinase, and PKMYT1, a closely
related kinase
- Hosted an investor event in May that featured the power of
Acrivon’s AP3 platform, which has the ability to match a drug’s
mechanism of action with relevant tumor-driving pathways, and
identify new indications, resistance mechanisms, and rational drug
combinations, as well as be applied for optimal drug selectivity
profiling
Anticipated Upcoming Milestones
- Report initial clinical readouts from the Phase 2 multicenter,
open-label ACR-368 trial in patients with platinum-resistant
ovarian, endometrial, and urothelial cancers during the second half
of 2023
- Option to initiate one or more clinical trials under the same
or a similar trial protocol design in patients with one or more of
three additional cancer types, including human papilloma
virus-positive squamous cell carcinomas, such as squamous cell
cancer of the head and neck, anal, and cervical cancers
- Advance one or both of our WEE1 and PKMYT1 inhibitor programs
targeting critical nodes in the DNA Damage Response pathways into
IND-enabling studies during 2023
Second Quarter 2023 Financial Results
Net loss for the quarter ended June 30, 2023 was $13.9 million
compared to a net loss of $5.8 million for the same period in
2022.
Research and development expenses were $10.5 million for the
quarter ended June 30, 2023 compared to $4.1 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 our earlier-stage research
programs.
General and administrative expenses were $5.0 million for the
quarter ended June 30, 2023 compared to $1.8 million for the same
period in 2022. The difference was primarily due to increased
personnel costs inclusive of non-cash stock-compensation related
expense, as well as the higher cost of operating as a public
company.
As of June 30, 2023, the company had cash, cash equivalents and
marketable securities of $151.0 million, which is expected to fund
operations into 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 enables 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. 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 targeting two critical nodes in the DNA Damage
Response, or DDR, including WEE1, a protein serine/threonine
kinase, and the closely related PKMYT1.
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
Levyalevy@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 June 30, |
|
Six Months Ended June 30, |
|
|
2023 |
|
|
|
2022 |
|
|
|
2023 |
|
|
|
2022 |
|
Operating expenses: |
|
|
|
|
|
|
|
Research and development |
$ |
10,521 |
|
|
$ |
4,077 |
|
|
$ |
20,279 |
|
|
$ |
10,145 |
|
General and administrative |
|
4,999 |
|
|
|
1,848 |
|
|
|
9,634 |
|
|
|
2,992 |
|
Total operating expenses |
|
15,520 |
|
|
|
5,925 |
|
|
|
29,913 |
|
|
|
13,137 |
|
Loss from operations |
|
(15,520 |
) |
|
|
(5,925 |
) |
|
|
(29,913 |
) |
|
|
(13,137 |
) |
Other income (expense): |
|
|
|
|
|
|
|
Other income, net |
|
1,606 |
|
|
|
105 |
|
|
|
3,243 |
|
|
|
97 |
|
Total other income, net |
|
1,606 |
|
|
|
105 |
|
|
|
3,243 |
|
|
|
97 |
|
Net loss |
$ |
(13,914 |
) |
|
$ |
(5,820 |
) |
|
$ |
(26,670 |
) |
|
$ |
(13,040 |
) |
Net loss per share - basic and
diluted |
$ |
(0.63 |
) |
|
$ |
(3.29 |
) |
|
$ |
(1.22 |
) |
|
$ |
(7.37 |
) |
Weighted-average common stock
outstanding - basic and diluted |
|
21,971,032 |
|
|
|
1,769,561 |
|
|
|
21,945,940 |
|
|
|
1,769,561 |
|
Comprehensive loss: |
|
|
|
|
|
|
|
Net loss |
$ |
(13,914 |
) |
|
$ |
(5,820 |
) |
|
$ |
(26,670 |
) |
|
$ |
(13,040 |
) |
Other comprehensive loss: |
|
|
|
|
|
|
|
Unrealized loss on available-for-sale investments, net of tax |
|
(436 |
) |
|
|
- |
|
|
|
(332 |
) |
|
|
- |
|
Comprehensive loss |
$ |
(14,350 |
) |
|
$ |
(5,820 |
) |
|
$ |
(27,002 |
) |
|
$ |
(13,040 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Note: The share count for 2022 excludes preferred shares. Upon
the closing of the Company’s IPO on November 17, 2022, all
outstanding shares of preferred stock converted into 11,140,262
shares of common stock.
Acrivon Therapeutics,
Inc.Condensed Consolidated Balance
Sheets(unaudited, in thousands)
|
|
June 30, 2023 |
|
|
|
December 31, 2022 |
|
|
|
|
|
|
|
|
|
Assets |
|
|
|
Cash and cash equivalents |
$ |
38,074 |
|
|
$ |
29,519 |
|
Short-term investments |
|
112,880 |
|
|
|
98,232 |
|
Long-term investments |
|
- |
|
|
|
41,881 |
|
Other assets |
|
9,095 |
|
|
|
11,594 |
|
Total assets |
$ |
160,049 |
|
|
$ |
181,226 |
|
Liabilities and
Stockholders' Equity |
|
|
|
Liabilities |
|
10,865 |
|
|
|
10,751 |
|
Stockholders' Equity |
|
149,184 |
|
|
|
170,475 |
|
Total Liabilities and Stockholders' Equity |
$ |
160,049 |
|
|
$ |
181,226 |
|
|
|
|
|
|
|
|
|
Grafico Azioni Acrivon Therapeutics (NASDAQ:ACRV)
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