Panbela Therapeutics, Inc. (Nasdaq:
PBLA), a clinical stage company developing disruptive therapeutics
for the treatment of patients with cancer, today provides a
business update and reports financial results for the quarter ended
March 31, 2022. Management is hosting an earnings call today at
4:30 p.m. ET.
The first quarter was marked by meaningful progress.
Q1 and Recent Highlights:
- Agreed to acquire Cancer Prevention Pharmaceuticals, Inc.
(CPP). The combined entity would target an estimated $5 billion
aggregated market opportunity upon closing.
- Hosted a virtual R&D Day on the company’s investigational
drug, SBP-101, as a polyamine metabolism modulator in ovarian
cancer.
- Poster presentation highlighting the results for SBP-101 as a
polyamine metabolism modulator in ovarian cancer at the American
Association for Cancer Research (AACR) in April 2022. The work
reflects the company’s ongoing collaboration with Johns Hopkins
University School of Medicine.
- Initiated our ASPIRE trial - a global, randomized,
double-blind, placebo controlled clinical trial of SBP-101 in
combination with Gemcitabine and Nab-Paclitaxel versus Gemcitabine,
Nab-paclitaxel and placebo in patients with untreated metastatic
pancreatic ductal adenocarcinoma.
- Announced a new development program in ovarian cancer expected
to start in the first half 2022 as the result of positive
preclinical data supporting the activity of SBP-101 in ovarian
cancer cell lines.
- Poster presentation of abstract for SBP-101 at the American
Society of Clinical Oncology (ASCO) Gastrointestinal Cancers
Symposium in January 2022.
- Median overall survival of 12.53 months for the phase 1 first
line metastatic pancreatic trial was reached shortly after the
January poster presentation.
“Q1 and year to date have represented a transformational time of
value creation for Panbela. During the quarter, we signed a
definitive agreement to acquire CPP, presented ovarian cancer data
at AACR and initiated our global randomized trial in pancreatic
cancer,” said Jennifer K. Simpson, PhD, MSN, CRNP, President &
Chief Executive Officer of Panbela. “Through the pending
acquisition and organic execution, Panbela is better positioned to
be able to treat more patients, and drive shareholder value.”
Milestones:
We announced:
- The ASCO GI poster presentation in January, and
- The research day to review the ovarian cancer data and ovarian
cancer treatment standards.
Additionally in the first half, we anticipate:
- First patient enrolled in our ASPIRE trial as well as expansion
outside the US.
- Satisfaction of conditions and closing of the CPP
acquisition.
- Final data from our Phase I untreated metastatic pancreatic
cancer study.
- Initiation of the ovarian cancer clinical program for SBP-101
mid-year.
In addition, during the second half of 2022, we expect to
announce the opening of a neoadjuvant pancreatic cancer
investigator initiated trial. Subject to closing the CPP
transaction, we anticipate announcing additional milestones for
2022 that will reflect the increased flow of planned development
activity and data.
First Quarter ended March 31, 2022 Financial
Results
General and administrative expenses were $1.8 million in the
first quarter of 2022, compared to $1.1 million in the first
quarter of 2021. The change is due primarily to expenses, including
legal and financial advisory fees, associated with the acquisition
of CPP.
Research and development expenses were $2.2 million in the first
quarter of 2022, compared to $1.1 million in the first quarter of
2021. The change is due primarily to an increase in spending on our
clinical studies as we launched the global ASPIRE clinical
trial.
Net loss in the first quarter of 2022 was $3.7 million, or $0.27
per diluted share, compared to a net loss of $2.3 million, or $0.23
per diluted share, in the first quarter of 2021.
Total cash was $7.4 million as of March 31, 2022. Total current
assets were $7.9 million and current liabilities were $4.5 million
as of the same date. Also at March 31, 2022, total noncurrent
assets, consisting of cash deposits held by our contract research
organization, were $3.2 million. The company had no debt as of
March 31, 2022.
Conference Call Information
To participate in this event, dial approximately 5 to 10 minutes
before the beginning of the call.
Date: May 12, 2022Time: 4:30 PM Eastern TimeToll Free:
888-506-0062; Access Code: 824126International: 973-528-0011;
Access Code: 824126
The call will also be available over the Internet and accessible
at: https://www.webcaster4.com/Webcast/Page/2556/45171
Conference Call Replay Information
Toll Free: 877-481-4010International: 919-882-2331Replay
Passcode: 44452
Webcast replay available until May 26, 2022:
https://www.webcaster4.com/Webcast/Page/2556/45171
About: SBP-101SBP-101 is a proprietary
polyamine analogue designed to induce polyamine metabolic
inhibition (PMI) by exploiting an observed high affinity of the
compound for pancreatic ductal adenocarcinoma, ovarian cancer and
other tumors. The molecule has shown signals of tumor growth
inhibition in clinical studies of US and Australian metastatic
pancreatic cancer patients, demonstrating a median overall survival
(OS) of 12.53 months, which is now final, and an objective response
rate (ORR) of 48%, both exceeding what is seen typically with the
standard of care of gemcitabine + nab-paclitaxel suggesting
potential complementary activity with the existing FDA-approved
standard chemotherapy regimen. In data evaluated from clinical
studies to date, SBP-101 has not shown exacerbation of bone marrow
suppression and peripheral neuropathy, which can be
chemotherapy-related adverse events. Serious visual adverse events
have been evaluated and patients with a history of retinopathy or
at risk of retinal detachment will be excluded from future SBP-101
studies. The safety data and PMI profile observed in the current
Panbela sponsored clinical trial provides support for continued
evaluation of SBP-101 in a randomized clinical trial. For more
information, please
visit https://clinicaltrials.gov/ct2/show/NCT03412799.
About PanbelaPanbela Therapeutics, Inc. is a
clinical-stage biopharmaceutical company developing disruptive
therapeutics for patients with urgent unmet medical needs. The
company’s initial product candidate, SBP-101, is for the treatment
of patients with metastatic pancreatic ductal adenocarcinoma, the
most common type of pancreatic cancer. Panbela Therapeutics, Inc.
is dedicated to treating patients with pancreatic cancer, ovarian
cancer, and exploring SBP-101’s potential for efficacy in
combination with other agents in other cancer indications. Further
information can be found
at www.panbela.com. Panbela
Therapeutics, Inc. common stock is listed on The Nasdaq Stock
Market LLC under the symbol PBLA.
Cautionary Statement Regarding Forward-Looking
StatementsThis press release contains “forward-looking
statements,” including within the meaning of the Private Securities
Litigation Reform Act of 1995. Forward-looking statements can be
identified by words such as: “anticipate,” “believe,” “could,”
“expect,” “feel,” “intend,” “may,” “plan,” “positioned,“
“scheduled,” and “will.” Examples of forward-looking statements
include statements we make regarding our potential expanded
pipeline and upcoming milestones. All statements other than
statements of historical fact are statements that should be deemed
forward-looking statements. Forward-looking statements are neither
historical facts nor assurances of future performance. Instead,
they are based only on our current beliefs, expectations, and
assumptions regarding the future of our business, future plans and
strategies, projections, anticipated events and trends, the economy
and other future conditions. 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 our control. Our actual results
and financial condition may differ materially and adversely from
the forward-looking statements. Therefore, you should not rely on
any of these forward-looking statements. Important factors that
could cause our actual results and financial condition to differ
materially from those indicated in the forward-looking statements
include, among others, the following: (i) risks related to the
consummation of the mergers, including the risks that (a) the
mergers may not be consummated within the anticipated time period,
or at all, (b) failure of our stockholders to approve the issuance
of shares contemplated by the merger agreement, (c) other
conditions to the consummation of the mergers under the merger
agreement may not be satisfied, and (d) the significant limitations
on remedies contained in the merger agreement may limit or entirely
prevent Panbela from specifically enforcing CPP’s obligations under
the merger agreement or recovering damages for any breach; (ii)
approval of the combined company’s application to list its shares
on Nasdaq; (iii) no assurance that future developments affecting
CPP will occur as anticipated; (iv) the effects that any
termination of the merger agreement may have on Panbela or its
business, including risk that the price of Panbela common stock may
decline significantly if the mergers are not completed; (v) the
effects that the announcement or pendency of the mergers may have
on Panbela and its operations, including the risks that as a result
(a) operating results or stock price of Panbela may suffer, (b) its
current plans and operations may be disrupted, (c) the ability of
Panbela to retain or recruit key employees may be adversely
affected, (d) its business relationships (including, clinicians,
CROs and suppliers) may be adversely affected, or (e) management
and employee attention may be diverted from other important
matters; (vi) the effect of limitations that the merger agreement
places on Panbela’s ability to operate its business or engage in
other transactions during the pendency of the transaction; (vii)
the nature, cost and outcome of future litigation and other legal
proceedings, including any such proceedings relating to the
transactions and instituted against Panbela and others; (viii) the
risk that the transaction may involve unexpected costs, liabilities
or delays; (ix) other economic, business, competitive, legal,
regulatory, and/or tax factors; (x) our ability and the combined
company’s ability to obtain additional funding to complete clinical
trials; (xi) progress and success of our Phase 1 clinical trial;
(xii) the impact of the current COVID-19 pandemic on our ability to
complete monitoring and reporting in our current clinical trial and
procure the active ingredient; (xiii) our ability to demonstrate
the safety and effectiveness of our SBP-101 product candidate;
(xiv) our ability to obtain regulatory approvals for our SBP-101
product candidate in the United States, the European Union or other
international markets; (xv) the market acceptance and level of
future sales of our SBP-101 product candidate; (xvi) the cost and
delays in product development that may result from changes in
regulatory oversight applicable to our SBP-101 product candidate;
(xvii) the rate of progress in establishing reimbursement
arrangements with third-party payors; (xviii) the effect of
competing technological and market developments; (xix) the costs
involved in filing and prosecuting patent applications and
enforcing or defending patent claims; and (xx) such other factors
as discussed in Part I, Item 1A under the caption “Risk Factors” in
our most recent Annual Report on Form 10-K, any additional risks
presented in our Quarterly Reports on Form 10-Q and our Current
Reports on Form 8-K. Any forward-looking statement made by us in
this press release is based on information currently available to
us and speaks only as of the date on which it is made. We undertake
no obligation to publicly update any forward-looking statement or
reasons why actual results would differ from those anticipated in
any such forward-looking statement, whether written or oral,
whether as a result of new information, future developments or
otherwise.
Contact Information:
Investors:James CarbonaraHayden IR(646)
755-7412james@haydenir.com
Media:Tammy GroenePanbela Therapeutics, Inc.(952) 479-1196 ext.
170IR@panbela.com
|
Panbela Therapeutics, Inc.Consolidated
Statements of Operations and Comprehensive Loss
(unaudited)(In thousands, except share and per share
amounts) |
|
|
|
Three months ended March 31, |
|
|
|
2022 |
|
|
|
2021 |
|
|
Percent Change |
Operating expenses: |
|
|
|
|
|
|
General and administrative |
|
$ |
1,796 |
|
|
$ |
1,149 |
|
|
56.3 |
% |
Research and development |
|
|
2,208 |
|
|
|
1,099 |
|
|
100.9 |
% |
Operating loss |
|
|
(4,004 |
) |
|
|
(2,248 |
) |
|
78.1 |
% |
|
|
|
|
|
|
|
Other income (expense): |
|
|
|
|
|
|
Interest income |
|
|
1 |
|
|
|
- |
|
|
- |
|
Interest expense |
|
|
(3 |
) |
|
|
(3 |
) |
|
0.0 |
% |
Other income (expense) |
|
|
311 |
|
|
|
(122 |
) |
|
-354.9 |
% |
Total other income (expense) |
|
|
309 |
|
|
|
(125 |
) |
|
-347.2 |
% |
|
|
|
|
|
|
|
Loss before income tax benefit |
|
|
(3,695 |
) |
|
|
(2,373 |
) |
|
55.7 |
% |
|
|
|
|
|
|
|
Income tax benefit |
|
|
29 |
|
|
|
116 |
|
|
-75.0 |
% |
|
|
|
|
|
|
|
Net loss |
|
|
(3,666 |
) |
|
|
(2,257 |
) |
|
62.4 |
% |
Foreign currency translation adjustment |
|
|
(299 |
) |
|
|
99 |
|
|
-402.0 |
% |
Comprehensive Loss |
|
$ |
(3,965 |
) |
|
$ |
(2,158 |
) |
|
83.7 |
% |
|
|
|
|
|
|
|
Basic and diluted net loss per share |
|
$ |
(0.27 |
) |
|
$ |
(0.23 |
) |
|
17.4 |
% |
Weighted average shares outstanding - basic and diluted |
|
|
13,445,732 |
|
|
|
9,887,578 |
|
|
36.0 |
% |
Panbela Therapeutics, Inc.Consolidated
Balance Sheets (unaudited)(In thousands, except share
amounts) |
|
|
|
March 31, 2022 |
|
December 31, 2021 |
ASSETS |
|
(Unaudited) |
|
|
Current assets: |
|
|
|
|
Cash and cash equivalents |
|
$ |
7,386 |
|
|
$ |
11,867 |
|
Prepaid expenses and other current assets |
|
|
182 |
|
|
|
91 |
|
Income tax receivable |
|
|
365 |
|
|
|
321 |
|
Total current assets |
|
|
7,933 |
|
|
|
12,279 |
|
Deposits held for clinical trial costs |
|
|
3,155 |
|
|
|
593 |
|
Total assets |
|
$ |
11,088 |
|
|
$ |
12,872 |
|
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS' EQUITY |
|
|
|
|
Current liabilities: |
|
|
|
|
Accounts payable |
|
$ |
3,986 |
|
|
$ |
640 |
|
Accrued expenses |
|
|
521 |
|
|
|
2,020 |
|
Total current liabilities |
|
|
4,507 |
|
|
|
2,660 |
|
|
|
|
|
|
Stockholders' equity: |
|
|
|
|
Preferred stock, $0.001 par value; 10,000,000 authorized; no shares
issued or outstanding as of March 31, 2022 and December 31,
2021 |
|
|
- |
|
|
|
- |
|
Common stock, $0.001 par value; 100,000,000 authorized; 13,449,117
and 13,443,722 shares issued and outstanding as of March 31, 2022
and December 31, 2021, respectively |
|
|
13 |
|
|
|
13 |
|
Additional paid-in capital |
|
|
66,561 |
|
|
|
66,227 |
|
Accumulated deficit |
|
|
(59,827 |
) |
|
|
(56,161 |
) |
Accumulated comprehensive (loss) income |
|
|
(166 |
) |
|
|
133 |
|
Total stockholders' equity |
|
|
6,581 |
|
|
|
10,212 |
|
Total liabilities and stockholders' equity |
|
$ |
11,088 |
|
|
$ |
12,872 |
|
Panbela Therapeutics, Inc.Consolidated
Statements of Cash Flows (unaudited)(In thousands) |
|
|
|
Three Months Ended March 31, |
|
|
|
2022 |
|
|
|
2021 |
|
Cash flows from operating activities: |
|
|
|
|
Net loss |
|
$ |
(3,666 |
) |
|
$ |
(2,257 |
) |
Adjustments to reconcile net loss to net cash used in operating
activities: |
|
|
|
|
Stock-based compensation |
|
|
334 |
|
|
|
252 |
|
Changes in operating assets and liabilities: |
|
|
|
|
Income tax receivable |
|
|
(33 |
) |
|
|
(113 |
) |
Prepaid expenses and other current assets |
|
|
(89 |
) |
|
|
100 |
|
Deposits held for clinical trial costs |
|
|
(2,561 |
) |
|
|
- |
|
Accounts payable |
|
|
3,030 |
|
|
|
334 |
|
Accrued liabilities |
|
|
(1,498 |
) |
|
|
(281 |
) |
Net cash used in operating activities |
|
|
(4,483 |
) |
|
|
(1,965 |
) |
Cash flows from financing activities: |
|
|
|
|
Proceeds from exercise of stock purchase warrants |
|
|
- |
|
|
|
1,042 |
|
Net cash provided by financing activities |
|
|
- |
|
|
|
1,042 |
|
|
|
|
|
|
Effect of exchange rate changes on cash |
|
|
2 |
|
|
|
(1 |
) |
|
|
|
|
|
Net change in cash |
|
|
(4,481 |
) |
|
|
(924 |
) |
Cash and cash equivalents at beginning of period |
|
|
11,867 |
|
|
|
9,022 |
|
Cash and cash equivalents at end of period |
|
$ |
7,386 |
|
|
$ |
8,098 |
|
|
|
|
|
|
Supplemental disclosure of cash flow
information: |
|
|
|
|
Cash paid during period for interest |
|
$ |
3 |
|
|
$ |
3 |
|
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