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 and
full year ended December 31, 2021. Management is hosting an
earnings call today at 4:30 p.m. ET.
The fourth quarter and full year 2021 was marked by meaningful
corporate, financial and clinical progress.
2021 and early 2022 Highlights:
- Agreed to acquire
Cancer Prevention Pharmaceuticals, Inc. (CPP) setting the stage for
a combined entity with an expanded pipeline addressing an estimated
$5 billion aggregated market opportunity upon closing.
- Initiated our
ASPIRE trial - a global, randomized, double-blind, placebo
controlled Phase II/III 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.
- Abstracts for
SBP-101 were accepted for poster presentations at both the American
Society of Clinical Oncology (ASCO) Gastrointestinal Cancers
Symposium in January 2022 and the ASCO Annual Meeting in June 2021;
Median overall survival of 12.53 months for the phase 1 first line
metastatic pancreatic trial reached shortly after the January
poster presentation.
- Announced issuance
of key U.S. Patent for claims of a novel, more efficient,
manufacturing process for the production of SBP-101.
- Closed a $10.0
million bought deal public offering of common stock on July 2,
2021.
- Joined the Russell
Microcap® Index.
- Formed a research
agreement with the Johns Hopkins University School of Medicine to
further development of Panbela’s investigative agent SBP-101,
including activity in cell lines outside of pancreatic cancer,
biomarkers informing diagnostics and potential combination with
checkpoint inhibitors.
“2021 and this year to date has been a transformative period of
significant value creation for Panbela. Most recently, we entered
into a definitive agreement to acquire CPP. The combined company
will have an expanded pipeline addressing an estimated $5 billion
aggregate market opportunity,” said Jennifer K. Simpson, PhD, MSN,
CRNP, President & Chief Executive Officer of Panbela. A few
highlights of the transaction include adding a lead asset with a
fully funded registration trial targeting familial adenomatous
polyposis (FAP) that is scheduled to begin this year. The
acquisition also adds an ongoing Phase III trial, the PACES trial,
in colon cancer survivors that is funded by National Cancer
Institute in collaboration with the Southwest Oncology Group
(SWOG). Additionally, CPP has clinical trials in neuroblastoma,
gastric cancer, and early-onset type-1 diabetes underway, each in
collaboration with various cooperative groups.
“Organically, Panbela has advanced our pancreatic cancer program
into a Phase II/III trial. Due to its rigor, we are optimistic that
the ASPIRE trial results, if positive, could support our
registration efforts. Additionally, we’ve expanded SBP-101 into
ovarian cancer based on positive preclinical results. We also
completed pre-clinical work for our neoadjuvant
investigator-initiated trial (IIT). Through pending M&A and
organic execution, Panbela is well positioned to treat more
patients and increase stockholder value,” continued Dr.
Simpson.
Upcoming Milestones:
For the first half of 2022, we expect to announce:
- Satisfaction of conditions and closing the CPP transaction
- First patient enrolled in our ASPIRE trial as well as expansion
outside the US
- We will host a Research call to review the ovarian cancer data
and ovarian cancer treatment standards
- Availability of Final Data – Phase I first- line metastatic
pancreatic cancer
- Initiation of SBP-101 development efforts in ovarian
cancer
Also, during the second half of 2022, we expect to announce the
opening of the Neoadjuvant Pancreatic Cancer IIT. With the expected
closing of the CPP transaction, we anticipate that additional
milestones for 2022 will reflect the increased flow of planned
development activity and data.
Fourth Quarter ended December 31, 2021 Financial
Results
General and administrative expenses were $1.3 million in the
fourth quarter of 2021, compared to $0.9 million in the fourth
quarter of 2020. The change is due to expenses, including legal and
financial advisory fees, associated with the acquisition of
CPP.
Research and development expenses were $2.0 million in the
fourth quarter of 2021, compared to $0.7 million in the fourth
quarter of 2020. The change is due primarily to an increase in
spending on our clinical studies as we prepared to launch the
ASPIRE clinical trial, as well as manufacturing expenses for
product and placebo required for this trial.
Net loss in the fourth quarter of 2021 was $3.5 million, or
$0.26 per diluted share, compared to a net loss of $0.9 million, or
$0.09 per diluted share, in the fourth quarter of 2020.
Total cash was $11.9 million as of December 31, 2021. Total
current assets were $12.3 million and current liabilities were $2.7
million as of the same date. The company had no debt as of December
31, 2021.
Conference Call Information
To participate in this event, dial approximately 5 to 10 minutes
before the beginning of the call.
Date: March 24, 2022Time: 4:30 PM Eastern TimeToll Free:
888-506-0062; Access Code: 461101International: 973-528-0011;
Access Code: 461101
Webcast: https://www.webcaster4.com/Webcast/Page/2556/44452
Conference Call Replay Information
Toll Free: 877-481-4010International: 919-882-2331Replay
Passcode: 44452
Webcast replay: Webcast:
https://www.webcaster4.com/Webcast/Page/2556/44452
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: “believe,” “could,” “expect,” “feel,”
“intend,” “may,” “plan,” “positioned,“ and “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
December 31, |
|
Year ended December
31, |
|
|
|
2021 |
|
|
|
2020 |
|
|
Percent Change |
|
|
2021 |
|
|
|
2020 |
|
|
Percent Change |
Operating
expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
General and administrative |
|
$ |
1,272 |
|
|
$ |
901 |
|
|
41.2 |
% |
|
$ |
4,587 |
|
|
$ |
3,249 |
|
|
41.2 |
% |
Research and development |
|
|
2,049 |
|
|
|
700 |
|
|
192.7 |
% |
|
|
5,423 |
|
|
|
2,505 |
|
|
116.5 |
% |
Operating loss |
|
|
(3,321 |
) |
|
|
(1,601 |
) |
|
107.4 |
% |
|
|
(10,010 |
) |
|
|
(5,754 |
) |
|
74.0 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
Other income
(expense): |
|
|
|
|
|
|
|
|
|
|
|
|
Interest expense |
|
|
(2 |
) |
|
|
(5 |
) |
|
-60.0 |
% |
|
|
(11 |
) |
|
|
(17 |
) |
|
-35.3 |
% |
Gain on debt forgiveness |
|
|
- |
|
|
|
103 |
|
|
-100.0 |
% |
|
|
- |
|
|
|
103 |
|
|
-100.0 |
% |
Other income (expense) |
|
|
2 |
|
|
|
550 |
|
|
-99.6 |
% |
|
|
(602 |
) |
|
|
605 |
|
|
-199.5 |
% |
Total other income (expense) |
|
|
- |
|
|
|
648 |
|
|
-100.0 |
% |
|
|
(613 |
) |
|
|
691 |
|
|
-188.7 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss before
income tax benefit |
|
|
(3,321 |
) |
|
|
(953 |
) |
|
248.5 |
% |
|
|
(10,623 |
) |
|
|
(5,063 |
) |
|
109.8 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
Income tax
benefit |
|
|
(218 |
) |
|
|
73 |
|
|
-398.6 |
% |
|
|
488 |
|
|
|
295 |
|
|
65.4 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
Net
loss |
|
|
(3,539 |
) |
|
|
(880 |
) |
|
302.2 |
% |
|
|
(10,135 |
) |
|
|
(4,768 |
) |
|
112.6 |
% |
Foreign
currency translation adjustment (loss) |
|
|
(50 |
) |
|
|
(525 |
) |
|
-90.5 |
% |
|
|
517 |
|
|
|
(688 |
) |
|
-175.1 |
% |
Comprehensive Loss |
|
$ |
(3,589 |
) |
|
$ |
(1,405 |
) |
|
155.4 |
% |
|
$ |
(9,618 |
) |
|
$ |
(5,456 |
) |
|
76.3 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted net loss per share |
$ |
(0.26 |
) |
|
$ |
(0.09 |
) |
|
188.9 |
% |
|
$ |
(0.87 |
) |
|
$ |
(0.62 |
) |
|
40.3 |
% |
Weighted
average shares outstanding - basic and diluted |
|
|
13,436,980 |
|
|
|
9,650,742 |
|
|
39.2 |
% |
|
|
11,709,035 |
|
|
|
7,732,882 |
|
|
51.4 |
% |
Panbela Therapeutics, Inc.Consolidated
Balance Sheets (unaudited)(In thousands, except share
amounts)
|
|
|
|
|
|
|
|
December 31, 2021 |
|
December 31, 2020 |
|
ASSETS |
|
|
|
|
|
Current
assets: |
|
|
|
|
|
Cash and cash equivalents |
|
$ |
11,867 |
|
|
$ |
9,022 |
|
|
Prepaid expenses and other current assets |
|
|
91 |
|
|
|
412 |
|
|
Income tax receivable |
|
|
321 |
|
|
|
323 |
|
|
Total
current assets |
|
|
12,279 |
|
|
|
9,757 |
|
|
Other
noncurrent assets |
|
|
593 |
|
|
|
56 |
|
|
Total
assets |
|
$ |
12,872 |
|
|
$ |
9,813 |
|
|
|
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS' EQUITY |
|
|
|
|
|
Current
liabilities: |
|
|
|
|
|
Accounts payable |
|
$ |
640 |
|
|
$ |
554 |
|
|
Accrued expenses |
|
|
2,020 |
|
|
|
811 |
|
|
Total
current liabilities |
|
|
2,660 |
|
|
|
1,365 |
|
|
Total
liabilities |
|
|
2,660 |
|
|
|
1,365 |
|
|
|
|
|
|
|
|
Stockholders' equity: |
|
|
|
|
|
Preferred stock, $0.001 par value; 10,000,000 authorized; no shares
issued or outstanding as of December 31, 2021 and December 31,
2020 |
|
|
- |
|
|
|
- |
|
|
Common stock, $0.001 par value; 100,000,000 authorized; 13,443,722
and 9,664,427 shares issued and outstanding, as of December 31,
2021 and December 31, 2020, respectively |
|
|
13 |
|
|
|
10 |
|
|
Additional paid-in capital |
|
|
66,227 |
|
|
|
54,848 |
|
|
Accumulated deficit |
|
|
(56,161 |
) |
|
|
(46,026 |
) |
|
Accumulated comprehensive income (loss) |
|
|
133 |
|
|
|
(384 |
) |
|
Total
stockholders' equity |
|
|
10,212 |
|
|
|
8,448 |
|
|
Total
liabilities and stockholders' equity |
|
$ |
12,872 |
|
|
$ |
9,813 |
|
|
|
|
|
|
|
|
Panbela Therapeutics, Inc.Consolidated
Statements of Cash Flows (unaudited)(In thousands)
|
|
|
|
|
|
|
Year Ended December 31, |
|
|
|
2021 |
|
|
|
2020 |
|
Cash
flows from operating activities: |
|
|
|
|
Net
loss |
|
$ |
(10,135 |
) |
|
$ |
(4,768 |
) |
Adjustments to reconcile net loss to net cash used in operating
activities: |
|
|
Stock-based compensation |
|
|
1,287 |
|
|
|
1,205 |
|
Forgiveness of Paycheck Protection Program loan |
|
|
- |
|
|
|
(103 |
) |
Changes in operating assets and liabilities: |
|
|
|
|
Income tax receivable |
|
|
51 |
|
|
|
(2 |
) |
Prepaid expenses and other current assets |
|
|
247 |
|
|
|
67 |
|
Accounts payable |
|
|
631 |
|
|
|
(747 |
) |
Accrued liabilities |
|
|
1,215 |
|
|
|
494 |
|
Net cash used in operating activities |
|
|
(6,704 |
) |
|
|
(3,854 |
) |
Cash
flows from investing activities: |
|
|
|
|
Deposits held by Contract Research Organizations |
|
|
(540 |
) |
|
|
- |
|
Net cash used in investing activities |
|
|
(540 |
) |
|
|
- |
|
Cash
flows from financing activities: |
|
|
|
|
Proceeds from sale of common stock and warrants net of offering
costs of $2 |
|
|
- |
|
|
|
1,746 |
|
Proceeds from public offering of common stock and warrants net of
underwriters discount and offering costs of $1,165 |
|
|
- |
|
|
|
9,335 |
|
Proceeds from public offering of common stock net of underwriters
discount and offering costs of $946 |
|
|
9,054 |
|
|
|
- |
|
Proceeds from exercise of warrants |
|
|
1,041 |
|
|
|
120 |
|
Proceeds from Paycheck Protection Program loan |
|
|
- |
|
|
|
103 |
|
Repayments of demand note |
|
|
- |
|
|
|
(743 |
) |
Repayments of term debt |
|
|
- |
|
|
|
(117 |
) |
Net cash provided by financing activities |
|
|
10,095 |
|
|
|
10,444 |
|
Effect of
exchange rate changes on cash |
|
|
(6 |
) |
|
|
(17 |
) |
Net change
in cash |
|
|
2,845 |
|
|
|
6,573 |
|
Cash and
cash equivalents at beginning of period |
|
|
9,022 |
|
|
|
2,449 |
|
Cash and
cash equivalents at end of period |
|
$ |
11,867 |
|
|
$ |
9,022 |
|
Supplemental disclosure of cash flow
information: |
|
|
|
|
Cash paid during period for interest |
|
$ |
12 |
|
|
$ |
8 |
|
Supplemental disclosure of non-cash
transactions: |
|
|
|
|
Warrants issued for future services |
|
$ |
- |
|
|
$ |
228 |
|
Warrants issued to underwriter |
|
$ |
- |
|
|
$ |
353 |
|
Amortization of warrants as offering costs |
|
$ |
- |
|
|
$ |
114 |
|
|
|
|
|
|
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