BiomX Reports Third Quarter 2021 Financial Results and Provides Business Update
November 15 2021 - 6:00AM
BiomX Inc. (NYSE American: PHGE) (“BiomX” or the “Company”), a
clinical-stage microbiome company advancing novel natural and
engineered phage therapies that target specific pathogenic
bacteria, reported today financial results and provided a business
update for the third quarter ended September 30, 2021.
“In planning for the years ahead, BiomX has made the decision to
prioritize the development of our cystic fibrosis and atopic
dermatitis product candidates, as each has the potential to
generate proof-of-concept clinical data readouts in 2022. BiomX
will also discontinue development of its acne program,” said
Jonathan Solomon, Chief Executive Officer of BiomX. “We believe
that by focusing on the efficient use of BiomX’s capital on
selected programs that can generate clinically meaningful,
proof-of-concept data, will best position our company to drive
value creation for shareholders. With this decision, we intend to
also postpone our development efforts temporarily in inflammatory
bowel disease and colorectal cancer until 2023.
“Importantly, our new strategic focus will have a positive
impact on our balance sheet. This new focus may allow us to extend
our cash runway by up to 6 months, until at least the end of 2023,
and additional tranches that may become available to us under our
venture debt facility upon satisfaction of certain specified
milestones may further extend our cash runway to the first half of
2024.” We therefore believe that we remain well-positioned
financially through our expected clinical data readouts in cystic
fibrosis and atopic dermatitis.”
RECENT
CORPORATE HIGHLIGHTS
- In October 2021, BiomX reported
topline results of the cosmetic Phase 2 acne study showing
statistically significant improvement from baseline observed in the
appearance of acne-prone skin but with no meaningful difference
demonstrated for BX001 relative to vehicle.
- In October 2021, BiomX entered into
an agreement with Maruho Co. Ltd., Japan’s largest
dermatology-focused pharmaceutical company, for a right of first
offer to license BiomX’s atopic dermatitis product candidate,
BX005, in Japan. The right of first offer will commence following
the availability of results from the Phase 1/2 study of BX005
expected in 2022. Maruho also entered into a binding agreement for
an equity investment in BiomX, intended primarily to support the
Phase 1/2 study, of $3 million at a premium to the market share
price.
- In September 2021, BiomX was cleared
by the U.S. Food and Drug Administration (FDA) to initiate a Phase
1b/2a trial of BX004 in cystic fibrosis patients with chronic
respiratory infections caused by Pseudomonas aeruginosa.
- In August 2021, the Company
announced that it entered into a debt financing agreement of up to
$30 million with Hercules Capital, Inc. (NYSE:HTGC). In July 2021,
BiomX announced it raised $15 million in a registered direct
offering of common stock and warrants.
Clinical Program Updates
Cystic Fibrosis (“CF”) (BX004)
- BX004 is being developed for the
treatment of chronic respiratory infections caused
by Pseudomonas aeruginosa, a main contributor to
morbidity and mortality in patients with CF.
- In September 2021, BX004 was cleared
by the FDA to initiate a Phase 1b/2a trial in CF patients with
chronic respiratory infections caused by Pseudomonas
aeruginosa.
- The Phase 1b/2a trial is composed of
two parts and is expected to start imminently. Part 1 of the trial
will evaluate the safety, pharmacokinetics and
microbiologic/clinical activity of BX004 in eight CF patients in a
single ascending dose and multiple dose design, with results
expected in the second quarter of 2022. Part 2 of the trial will
evaluate the safety and efficacy of BX004 in 24 CF patients
randomized to a treatment or placebo cohort in a 2:1 ratio. Results
from Part 2 are expected by the third quarter of 2022.
Atopic Dermatitis
(“AD”)
(BX005)
- BX005 is designed to shift the skin
microbiome composition of AD patients to its “pre-flare” state by
reducing Staphylococcus aureusburden, potentially resulting in
clinical improvement.
- BX005 is currently in the final
stages of GMP production. Due to delays in communications with the
FDA attributable to COVID-related matters, the Company now expects
results from its Phase 1/2 proof-of-concept trial evaluating the
safety and efficacy of BX005 in the third quarter of 2022 instead
of the first half of 2022.
Inflammatory Bowel Disease
(“IBD”) and Colorectal
Cancer Programs
- Consistent with the new strategic
focus on CF and AD programs and the efficient deployment of BiomX
capital, the Company plans to temporarily pause its development
efforts in IBD and colorectal cancer until early 2023, as neither
program would otherwise be expected to yield proof-of-concept data
in patients through the end of 2022.
Acne-Prone Skin (BX001)
- Based upon the topline results of
the cosmetic Phase 2 acne trial previously announced in October
2021, the Company has now determined that it is discontinuing this
program to focus resources on the CF and AD programs.
Third Quarter 2021 Financial
Results
- Cash balance and short-term
deposits as of September 30, 2021,
were $68.3 million, compared to $57.1 million as of December 31,
2020. The increase was primarily due to net cash provided by
financing activities partially offset with net cash used in
operating activities. During the third quarter, the Company
completed a $15 million registered direct equity financing and debt
financing agreement of up to $30 million. Based upon the BiomX’s
new strategic focus on its cystic fibrosis and atopic dermatitis
programs, the Company now expects its existing cash, cash
equivalents and short-term deposits to be sufficient to fund the
Company’s current operating plan until the end of 2023. Additional
tranches that will become available to the Company under its
venture debt facility upon satisfaction of certain specified
milestones can further extend the Company’s cash runway to the
first half of 2024.
- Research and development (R&D) expenses,
net were $6.6 million for the three
months ended September 30, 2021, compared to $6.1 million for the
same period in 2020. The increase was primarily due to increased
expenses related to conducting pre-clinical and clinical trials of
our product candidates and an increase in stock-based compensation
and salaries and related expenses, mainly due to the growth in the
number of employees in R&D and clinical activities.
- General and administrative
expenses were $2.8 million for the
three months ended September 30, 2021, compared to $2.4 million for
the same period in 2020. The increase was primarily due to
increases in stock-based compensation and salaries and related
expenses, mainly due to the growth in the number of employees, due
to an increase in expenses associated with operating as a public
company, such as directors’ and officers’ insurance and due to
expenses resulted from moving into new premises.
- Net loss for the third
quarter of 2021 was $10.0 million, compared to $8.8 million for the
same period in 2020.
- Net cash used in operating
activities for the nine months ended September 30,
2021 was $18.5 million, compared to $17.3 million for the same
period in 2020.
Conference Call and Webcast Information
BiomX management will host a conference call and webcast today
at 8:00 am ET to report financial results and business updates for
the third quarter 2021 ended September 30, 2021. To participate in
the conference, please dial 1-877-407-0724 (U.S.), 1-809-406-247
(Israel), or 1-201-389-0898 (International). A live and archived
webcast of the call will be available on the Investors section of
the Company’s website at www.biomx.com.
About BiomX
BiomX is a clinical-stage microbiome company developing both
natural and engineered phage cocktails designed to target and
destroy bacteria in the treatment of chronic diseases, such as
cystic fibrosis, atopic dermatitis, inflammatory bowel disease,
primary sclerosing cholangitis, and colorectal cancer. BiomX
discovers and validates proprietary bacterial targets and
customizes phage compositions against these targets.
Additional information is available at www.biomx.com, the
content of which does not form a part of this press release.
Safe Harbor
This press release contains express or implied “forward-looking
statements” within the meaning of the “safe harbor” provisions of
the U.S. Private Securities Litigation Reform Act of 1995.
Forward-looking statements can be identified by words such as:
“target,” “believe,” “expect,” “will,” “may,” “anticipate,”
“estimate,” “would,” “positioned,” “future,” and other similar
expressions that predict or indicate future events or trends or
that are not statements of historical matters. For example, when
BiomX discusses its expectations regarding the sufficiency of cash,
cash equivalents and short-term deposits to fund the Company’s
current operating plan until at least the end of 2023, or even
later, the ability of its products to address unmet medical needs,
the potential to receive up to $15 million in additional loan
tranches if certain milestones are met, the design, aim, expected
timing and results of its preclinical and clinical trials and
studies, including resumption of certain development programs, as
well as its pipeline and the potential of its product candidates,
BiomX is making forward-looking statements. Forward-looking
statements are neither historical facts nor assurances of future
performance. Instead, they are based only on BiomX management’s
current beliefs, expectations and assumptions. Because
forward-looking statements relate to the future, they are subject
to inherent uncertainties, risks and changes in circumstances that
are difficult to predict and many of which are outside of BiomX
control. Actual results and outcomes may differ materially from
those indicated in the forward-looking statements. Therefore,
investors should not rely on any of these forward-looking
statements and should review the risks and uncertainties described
under the caption “Risk Factors” in BiomX’s Annual Report on Form
10-K filed with the Securities and Exchange Commission (the “SEC”)
on March 31, 2021 and additional disclosures BiomX makes in its
other filings with the SEC, which are available on the SEC’s
website at www.sec.gov. Forward-looking statements are made as
of the date of this press release, and except as provided by law
BiomX expressly disclaims any obligation or undertaking to update
forward-looking statements.
BIOMX INC.
CONDENSED CONSOLIDATED STATEMENTS OF
OPERATIONS (unaudited)
USD in thousands, except share and per
share data
|
|
|
|
Three Months Ended September 30,
|
|
|
Nine Months Ended September 30,
|
|
|
|
Note
|
|
2021
|
|
|
2020
|
|
|
2021
|
|
|
2020
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development (“R&D”) expenses, net
|
|
|
|
|
6,608
|
|
|
|
6,056
|
|
|
|
16,102
|
|
|
|
13,302
|
|
Amortization of intangible assets
|
|
|
|
|
380
|
|
|
|
380
|
|
|
|
1,139
|
|
|
|
1,139
|
|
General and administrative expenses
|
|
|
|
|
2,845
|
|
|
|
2,394
|
|
|
|
8,436
|
|
|
|
6,749
|
|
Operating loss
|
|
|
|
|
9,833
|
|
|
|
8,830
|
|
|
|
25,677
|
|
|
|
21,190
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Financial expenses (income), net
|
|
|
|
|
188
|
|
|
|
5
|
|
|
|
76
|
|
|
|
248)
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss before tax
|
|
|
|
|
10,021
|
|
|
|
8,835
|
|
|
|
25,753
|
|
|
|
20,942
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Tax expenses
|
|
|
|
|
10
|
|
|
|
-
|
|
|
|
16
|
|
|
|
-
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net Loss
|
|
|
|
|
10,031
|
|
|
|
8,835
|
|
|
|
25,769
|
|
|
|
20,942
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted loss per share of Common Stock
|
|
6
|
|
|
0.37
|
|
|
|
0.38
|
|
|
|
1.03
|
|
|
|
0.91
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average number of shares of Common Stock outstanding,
basic and diluted
|
|
|
|
|
27,077,903
|
|
|
|
23,150,253
|
|
|
|
25,120,037
|
|
|
|
23,013,790
|
|
BIOMX INC.
CONDENSED CONSOLIDATED BALANCE
SHEETS (unaudited)
USD in thousands
|
|
|
|
As of
|
|
|
|
Note
|
|
September 30,2021
|
|
|
December 31, 2020
|
|
ASSETS
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Current assets
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents
|
|
|
|
|
67,346
|
|
|
|
36,477
|
|
Restricted cash
|
|
|
|
|
985
|
|
|
|
763
|
|
Short-term deposits
|
|
|
|
|
-
|
|
|
|
19,851
|
|
Other current assets
|
|
|
|
|
1,467
|
|
|
|
3,576
|
|
Total current assets
|
|
|
|
|
69,798
|
|
|
|
60,667
|
|
|
|
|
|
|
|
|
|
|
|
|
Property and equipment, net
|
|
|
|
|
5,863
|
|
|
|
2,228
|
|
Intangible assets, net
|
|
|
|
|
1,899
|
|
|
|
3,038
|
|
Operating lease right-of-use assets
|
|
|
|
|
4,239
|
|
|
|
4,430
|
|
Total non-current assets
|
|
|
|
|
12,001
|
|
|
|
9,696
|
|
|
|
|
|
|
81,799
|
|
|
|
70,363
|
|
|
|
|
|
As of
|
|
|
|
Note
|
|
September 30,2021
|
|
|
December 31,2020
|
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS’ EQUITY
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Current liabilities
|
|
|
|
|
|
|
|
|
Trade account payables
|
|
|
|
|
1,879
|
|
|
|
2,320
|
|
Other account payables
|
|
|
|
|
6,321
|
|
|
|
3,978
|
|
Current portion of operating lease liabilities
|
|
|
|
|
799
|
|
|
|
863
|
|
Total current liabilities
|
|
|
|
|
8,999
|
|
|
|
7,161
|
|
|
|
|
|
|
|
|
|
|
|
|
Non-current liabilities
|
|
|
|
|
|
|
|
|
|
|
Long-term debt
|
|
4
|
|
|
14,225
|
|
|
|
-
|
|
Operating lease liabilities, net of current portion
|
|
|
|
|
4,728
|
|
|
|
5,032
|
|
Other liabilities
|
|
|
|
|
420
|
|
|
|
701
|
|
Total non-current liabilities
|
|
|
|
|
19,373
|
|
|
|
5,733
|
|
|
|
|
|
|
|
|
|
|
|
|
Commitments and Collaborations
|
|
3
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stockholders’ equity
|
|
5
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Preferred Stock, $0.0001 par value; Authorized - 1,000,000
shares as of September 30, 2021 and December 31, 2020. No shares
issued and outstanding as of September 30, 2021 and December 31,
2020.
|
|
|
|
|
-
|
|
|
|
-
|
|
Common Stock, $0.0001 par value; Authorized - 60,000,000 shares
as of September 30, 2021 and December 31, 2020. Issued – 28,206,229
shares as of September 30, 2021 and 23,270,337 shares as of
December 31, 2020. Outstanding – 28,200,529 shares as of September
30, 2021 and 23,264,637 shares as of December 31, 2020.
|
|
|
|
|
3
|
|
|
|
2
|
|
|
|
|
|
|
|
|
|
|
|
|
Additional paid in capital
|
|
|
|
|
151,451
|
|
|
|
129,725
|
|
Accumulated deficit
|
|
|
|
|
(98,027
|
)
|
|
|
(72,258
|
)
|
Total stockholders’ equity
|
|
|
|
|
53,427
|
|
|
|
57,469
|
|
|
|
|
|
|
81,799
|
|
|
|
70,363
|
|
BiomX, Inc.Anat PrimovichCorporate Project
Manager+972506977228anatp@biomx.com
Source: BiomX Inc
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