BiomX Inc. (NYSE American: PHGE) (“BiomX” or the “Company”), a
clinical-stage microbiome company advancing novel natural and
engineered phage cocktails that target specific pathogenic
bacteria, today reported financial results and provided a business
update for the second quarter ended June 30, 2021.
“BiomX is approaching several important potential inflection
points, with expected Phase 1b/2a or Phase 2 data readouts in four
distinct indications by mid-2022, including a first readout from
our Phase 2 acne study of BX001 expected in October,” said Jonathan
Solomon, Chief Executive Officer of BiomX. “Following our $15
million equity financing in July, which included participation by
all of the members of our Board of Directors, and an up to $30
million venture debt agreement, BiomX is well-funded through these
clinical data readouts, and to at least mid-2023. Entering a
data-rich period for our company, we believe BiomX remains uniquely
positioned at the forefront of developing precision medicines that
target pathogenic bacteria to address the significant unmet medical
need remaining in indications such as cystic fibrosis, atopic
dermatitis, acne-prone skin, and inflammatory bowel disease.”
RECENT HIGHLIGHTS AND KEY UPCOMING
MILESTONES
Completion of a Registered Direct Financing in July
Raising Gross Proceeds of $15 Million
On July 26, 2021, BiomX announced a registered direct
offering of the Company’s common stock and warrants for gross
proceeds of $15 million, before fees and expenses and assuming that
none of the warrants are exercised. The offering closed on July 28,
2021.
$30 Million Venture Debt Financing Agreement
with Hercules Capital
BiomX also announced today that it has entered into a $30
million debt financing agreement with Hercules Capital, Inc.
(NYSE: HTGC) ("Hercules"), a leader in customized debt
financing for companies in life sciences and technology-related
markets.
The first $15 million tranche is available upon closing. Two
subsequent tranches of $10 million and $5 million will become
available upon the achievement of certain milestones. The loan is
for a term of 48 months and, during the first 18 months, BiomX is
expected to pay only interest on the principal. The loan term and
the interest only period may be extended to up to 60 and 30 months,
respectively, upon satisfaction of certain milestones. No
warrants were issued in connection with the debt financing.
Clinical Program Updates
Acne-Prone Skin (BX001)
- In May 2021, BiomX announced completion of enrollment in its
Phase 2 cosmetic clinical study of BX001. BX001 is a topical gel
that includes a combination of naturally occurring phage that
specifically target Cutibacterium acnes. The study is
evaluating reduction in Cutibacterium acnes burden as
well as improvement in the appearance of acne-prone skin in 140
subjects with mild-to-moderate acne vulgaris. The trial is a
12-week randomized, single center, double-blind, placebo-controlled
study.
- Topline results from Study BMX-001-007 were on track to be
reported following the 8- and 12-week treatment periods in the
third and fourth quarters of 2021, respectively. Because enrollment
in this study was completed two weeks ahead of schedule, a decision
was made to forego the interim 8-week analysis, continue the
blinded status of the study until study completion, and conduct all
analyses (8-week and 12-week) at the same time. Hence, we expect
the full study readout will be available at end of October, only a
few weeks after the planned interim analysis.
Inflammatory Bowel Disease (“IBD”) and Primary
Sclerosing Cholangitis (“PSC”) (BX003)
- On May 26, 2021, BiomX hosted a Key Opinion Leader (“KOL”)
webinar focusing on BX003, the Company’s microbiome-based
therapeutic, for IBD. The event featured KOL, Ryan Balfour Sartor,
M.D., who discussed the IBD treatment landscape as well as the
unmet medical need for these patients. Dr. Sartor was also joined
by BiomX management, who provided updates on the BX003 program for
IBD and PSC.
- Based on the previous promising results from the Phase 1a trial
of BX002, which showed that orally administered BX002 was safe,
well-tolerated and met its key objective of delivering viable phage
at high concentrations to the lower gut, BiomX plans to initiate a
Phase 1b/2a study to evaluate the safety, tolerability, and
activity of BX003 in 60 subjects. The goal of this study is to
demonstrate reduction of the target bacteria, Klebsiella
pneumoniae, as measured in stool of target bacteria carriers.
Results from this study are expected in the second quarter of 2022.
Cystic Fibrosis (“CF”) (BX004)
- In June 2021, at the 44th European Cystic Fibrosis Conference,
BiomX presented preclinical data highlighting in vitro results
showing that BX004 was able to penetrate biofilm and was
efficacious in significantly reducing levels of embedded
Pseudomonas aeruginosa , as compared to two
different antibiotics. 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 May 2021, BiomX updated its CF clinical trial design and
timelines by advancing BX004 into a two-part Phase 1b/2a trial in
CF patients with chronic respiratory infections caused
by Pseudomonas aeruginosa. 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 first quarter of 2022.
Part 2 of the trial will evaluate the safety and efficacy of BX004
in 21 CF patients randomized to a treatment or placebo cohort in a
2:1 ratio. Results from Part 2 are expected by the second quarter
of 2022.
Atopic Dermatitis (BX005)
- In June 2021, preclinical results with BX005 for atopic
dermatitis were presented at the Revolutionizing Atopic Dermatitis
2021 Virtual Conference and the International Conference on Phage
Therapy and Bacteriophages. BX005 demonstrated broad target
bacteria host range and efficient eradication
of Staphylococcus aureus (S. aureus) strains with no
emergence of resistant mutants for 24 hours in vitro, By
reducing S. aureus burden, BX005 is designed to shift the
skin microbiome composition of atopic dermatitis patients to its
“pre-flare” state to potentially result in clinical
improvement.
- The Company expects results from a Phase 2 proof-of-concept
trial evaluating the safety and efficacy of BX005 in atopic
dermatitis patients in the first half of 2022.
Colorectal Cancer
- BiomX is exploring phage-mediated delivery of therapeutic
payloads, such as immune-stimulating proteins, GM-CSF and IL-15,
for the treatment of colorectal cancer, by targeting Fusobacterium
nucleatum bacteria, which are present within a majority of
colorectal tumors.
- BiomX expects to report results from preclinical in
vivo studies evaluating the use of phage therapy for
colorectal cancer in the fourth quarter of 2021.
Second Quarter 2021 Financial Results
- Cash balance and short-term
deposits as of June 30, 2021, were
$47.3 million, compared to $57.1 million as of December 31, 2020.
The decrease was primarily due to net cash used in operating
activities. Not yet included in the $47.3 million cash balance are
financings completed after June 30, 2021, namely the completed $15
million registered direct equity financing and the initial $15
million tranche of the venture debt financing agreement. Including
the net proceeds from these two offerings, the Company expects
existing cash, cash equivalents and short-term deposits to be
sufficient to fund the Company’s current operating plan until at
least mid-2023.
- Research and
development (R&D) expenses,
net were $3.8 million for the three
months ended June 30, 2021, compared to $3.7 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, partially
offset by an increase in IIA grants that were recorded during the
period.
- General and
administrative expenses were $3.1
million for the three months ended June 30, 2021, compared to $2.3
million for the same period in 2020. The increase was primarily due
to an increase 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 from moving into new premises.
- Net
loss for the second quarter of 2021
was $7.3 million, compared to $6.2 million for the same period in
2020.
- Net cash
used in operating activities for the six months ended
June 30, 2021 was $12.8 million, compared to $11.4 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 second quarter 2021 ended June 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 that affect the appearance of skin, as well as
target bacteria in the treatment of chronic diseases, such as
inflammatory bowel disease, primary sclerosing cholangitis, cystic
fibrosis, atopic dermatitis 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 mid-2023, the ability of its
products to address unmet medical needs, the potential for up to
$15 million in additional loan tranches if certain milestones are
met, the potential for extensions of the loan term and interest
periods if certain milestones are met, the capabilities of the BOLT
platform, the design, aim, expected timing and results of its
preclinical and clinical trials, readouts and studies, 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 June 30, 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 EndedJune 30, |
|
|
Six Months EndedJune 30, |
|
|
|
2021 |
|
|
2020 |
|
|
|
2021 |
|
|
|
2020 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development (“R&D”) expenses, net |
|
|
3,824 |
|
|
|
3,717 |
|
|
|
|
9,494 |
|
|
|
|
7,246 |
|
|
Amortization of intangible
assets |
|
|
380 |
|
|
|
380 |
|
|
|
|
759 |
|
|
|
|
759 |
|
|
General and administrative
expenses |
|
|
3,098 |
|
|
|
2,297 |
|
|
|
|
5,591 |
|
|
|
|
4,355 |
|
|
Operating loss |
|
|
7,302 |
|
|
|
6,394 |
|
|
|
|
15,844 |
|
|
|
|
12,360 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Financial expenses (income),
net |
|
|
31 |
|
|
|
(188 |
) |
|
|
|
(112 |
) |
|
|
|
(253 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss before
tax |
|
|
7,333 |
|
|
|
6,206 |
|
|
|
|
15,732 |
|
|
|
|
12,107 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Tax expenses |
|
|
3 |
|
|
|
- |
|
|
|
|
6 |
|
|
|
|
- |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net Loss |
|
|
7,336 |
|
|
|
6,206 |
|
|
|
|
15,738 |
|
|
|
|
12,107 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted loss per
share of Common Stock |
|
|
0.30 |
|
|
|
0.27 |
|
|
|
|
0.65 |
|
|
|
|
0.53 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average number of
shares of Common Stock outstanding, basic and diluted |
|
|
24,320,259 |
|
|
|
22,969,075 |
|
|
|
|
24,134,065 |
|
|
|
|
22,944,482 |
|
|
BIOMX INC.
CONDENSED CONSOLIDATED BALANCE
SHEETS (unaudited)
USD in thousands
|
|
As of |
|
|
|
June 30, 2021 |
|
|
December 31, 2020 |
|
ASSETS |
|
|
|
|
|
|
|
|
|
|
|
|
|
Current
assets |
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
|
46,271 |
|
|
|
36,477 |
|
Restricted cash |
|
|
982 |
|
|
|
763 |
|
Short-term deposits |
|
|
- |
|
|
|
19,851 |
|
Other current assets |
|
|
2,585 |
|
|
|
3,576 |
|
Total current assets |
|
|
49,838 |
|
|
|
60,667 |
|
|
|
|
|
|
|
|
|
|
Property and equipment,
net |
|
|
5,122 |
|
|
|
2,228 |
|
Intangible assets, net |
|
|
2,279 |
|
|
|
3,038 |
|
Operating lease right-of-use
assets |
|
|
4,410 |
|
|
|
4,430 |
|
Total non-current assets |
|
|
11,811 |
|
|
|
9,696 |
|
|
|
|
|
|
|
|
|
|
|
|
|
61,649 |
|
|
|
70,363 |
|
|
|
As of |
|
|
|
June 30, 2021 |
|
|
December 31, 2020 |
|
|
|
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS’ EQUITY |
|
|
|
|
|
|
|
|
|
|
|
|
|
Current liabilities |
|
|
|
|
|
|
Trade account payables |
|
1,769 |
|
|
2,320 |
|
Other account payables |
|
5,199 |
|
|
3,978 |
|
Current portion of operating lease liabilities |
|
791 |
|
|
863 |
|
Total current liabilities |
|
7,759 |
|
|
7,161 |
|
|
|
|
|
|
|
|
Non-current liabilities |
|
|
|
|
|
|
Operating lease liabilities, net of current portion |
|
4,879 |
|
|
5,032 |
|
Contingent considerations |
|
419 |
|
|
701 |
|
Total non-current liabilities |
|
5,298 |
|
|
5,733 |
|
|
|
|
|
|
|
|
Commitments and Contingent Considerations |
|
|
|
|
|
|
|
|
|
|
|
|
|
Stockholders’ equity |
|
|
|
|
|
|
|
|
|
|
|
|
|
Preferred stock, $0.0001 par value; Authorized - 1,000,000 shares
as of June 30, 2021 and December 31, 2020. No shares issued and
outstanding as of June 30, 2021 and December 31, 2020. |
|
- |
|
|
- |
|
Common stock, $0.0001 par value; Authorized - 60,000,000 shares as
of June 30, 2021 and December 31, 2020. Issued – 24,434,776 shares
as of June 30, 2021 and 23,270,337 shares as of December 31, 2020.
Outstanding – 24,429,076 shares as of June 30, 2021 and 23,264,637
shares as of December 31, 2020. |
|
2 |
|
|
2 |
|
|
|
|
|
|
|
|
Additional paid in capital |
|
136,586 |
|
|
129,725 |
|
Accumulated deficit |
|
(87,996 |
) |
|
(72,258 |
) |
Total stockholders’ equity |
|
48,592 |
|
|
57,469 |
|
|
|
61,649 |
|
|
70,363 |
|
BiomX, Inc. Assaf Oron Chief Business Officer +972 (54) 222-8901
assafo@biomx.com
Source: BiomX Inc
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