Panbela Therapeutics, Inc. (Nasdaq: PBLA), a
clinical stage company developing disruptive therapeutics for the
treatment of patients with urgent unmet medical needs, today
provides a business update and reports financial results for the
quarter ended June 30, 2022. Management is hosting an earnings
conference call today at 4:30 p.m. ET.
The second quarter was marked by meaningful progress.
Q2 and Recent Highlights:
- First Patient
Enrolled in its Aspire Trial.
- Received approval
from the Australian Human Research Ethics Committee (HREC) to
expand the company’s global clinical trial to Australia.
- Closed on the
acquisition of Cancer Prevention Pharmaceuticals, Inc. (CPP).
- Hosted a virtual
R&D Day on the company’s investigational drug, ivospemin
(SBP-101), as a polyamine metabolism modulator in ovarian
cancer.
- Poster
presentation highlighting the results for ivospemin (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.
“Through the second quarter we significantly increased our
addressable market at Panbela. First, during the quarter we closed
on our definitive agreement to acquire CPP. The combined entity
targets an estimated $5 billion aggregated market opportunity.
Additionally, we presented ovarian cancer data at AACR, supporting
SBP-101’s potential use beyond our first indication, pancreatic
cancer,” said Jennifer K. Simpson, PhD, MSN, CRNP, President &
Chief Executive Officer of Panbela. “Via our acquisition of CPP and
organic operational advancements, Panbela now has a diversified
pipeline, with an ability to hit multiple targets. The development
programs now consists of the randomized, double-blind, placebo
controlled trial in first line metastatic pancreatic cancer
patients, and a Phase III clinical trial funded by the National
Cancer Institute (the “NCI”) for the study of colon cancer risk
reduction and colon adenoma therapy (“CAT”). Additional programs
are evaluating a single agent tablet eflornithine (CPP-1X) or high
dose powder eflornithine sachet (CPP-1X-S) for several indications
including prevention of gastric cancer and treatment of high risk
refractory neuroblastoma. As we now have programs
ranging from pre-clinical to registration studies, including a lead
asset with a fully funded registration trial scheduled to begin in
early 2023, we expect a steady flow of achievements.”
During the second half of 2022, we expect to announce final data
from our Phase I untreated metastatic pancreatic cancer study, and
the opening of a neoadjuvant pancreatic cancer
investigator-initiated trial with ivospemin (SBP-101). With the
closing of the CPP transaction, we also anticipate achieving
additional milestones during the remainder of 2022 that will
reflect the increased flow of planned development activity and
data. These milestones include initiation of a Phase I/II program
in non-small cell lung cancer and a Phase II study in Type I onset
Diabetes.
Second quarter ended June 30, 2022 Financial
Results
General and administrative expenses were $1.3 million in the
second quarter of 2022, compared to $1.2 million in the second
quarter of 2021. The change is due primarily to legal fees,
associated with the acquisition of CPP.
Research and development expenses were $20.0 million in the
second quarter of 2022, inclusive of a one-time, non-cash expense
of $17.7 million. This expense was the write-off of in process
research and development (or IPR&D). The company has accounted
for the acquisition of CPP as an asset purchase. IPR&D
represents the asset purchased and asset acquisition accounting
requires writing off this asset immediately after the acquisition.
The remaining R&D expense in the quarter of approximately $2.3
million compares to $1.0 million in the second quarter of 2021.
This is related to an increase in spending on our clinical
studies.
Net loss in the second quarter of 2022 was $21.1 million, or
$1.51 per diluted share, compared to a net loss of $2.2 million, or
$0.22 per diluted share, in the second quarter of 2021.
Total cash was $2.5 million as of June 30, 2022. Total current
assets were $3.5 million and current liabilities were $6.2 million
as of the same date. Also at June 30, 2022, total noncurrent
assets, consisting of cash deposits held by our contract research
organization, were $3.1 million. New notes payable on the balance
sheet, the result of the acquisition of CPP, totaled approximately
$6.9 million. Current portion of the notes payable plus accrued
interest totaled approximately $1.7 million.
Conference Call Information
To participate in this event, dial approximately 5 to 10 minutes
before the beginning of the call.
Date: August 15, 2022Time: 4:30 PM Eastern TimeToll Free:
888-506-0062; Access Code: 429849International: 973-528-0011;
Access Code: 429849Webcast Link:
https://www.webcaster4.com/Webcast/Page/2556/45649
Conference Call Replay Information
Toll Free: 877-481-4010International: 919-882-2331Replay
Passcode: 45649
Replay Webcast Link:
https://www.webcaster4.com/Webcast/Page/2556/45649
About our Pipeline
The pipeline consists of assets currently in clinical trials
with an initial focus on familial adenomatous polyposis (FAP),
first-line metastatic pancreatic cancer, neoadjuvant pancreatic
cancer, colorectal cancer prevention and ovarian cancer. The
combined development programs have a steady cadence of news flow
with programs ranging from pre-clinical to registration
studies.
SBP-101
SBP-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 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 14.6 months which is 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
Flynpovi™
Flynpovi is a combination of CPP-1X (eflornithine) and sulindac
with a dual mechanism inhibiting polyamine synthesis and increasing
polyamine export and catabolism. In a Phase 3 clinical trial in
patients with sporadic large bowel polyps, the combination
prevented > 90% subsequent pre-cancerous sporadic adenomas
versus placebo. Focusing on FAP patients with lower
gastrointestinal tract anatomy in the recent Phase 3 trial
comparing Flynpovi to single agent eflornithine and single agent
sulindac, FAP patients with lower GI anatomy (patients with an
intact colon, retained rectum or surgical pouch), Flynpovi showed
statistically significant benefit compared to both single agents
(p≤0.02) in delaying surgical events in the lower GI for up to four
years. The safety profile for Flynpovi did not significantly differ
from the single agents and supports the continued evaluation of
Flynpovi for FAP.
CPP-1X
CPP-1X (eflornithine) is being developed as a single agent
tablet or high dose power sachet for several indications including
prevention of gastric cancer, treatment of neuroblastoma and recent
onset Type 1 diabetes. Preclinical studies as well as Phase 1 or
Phase 2 investigator-initiated trials suggest that CPP-1X treatment
is well tolerated and has potential activity.
About Panbela
Panbela Therapeutics, Inc. is a clinical-stage biopharmaceutical
company developing disruptive therapeutics for patients with urgent
unmet medical needs. The company’s lead assets are SBP-101 and
Flynpovi. Further information can be found
at https://panbela.com. Panbela
Therapeutics, Inc. common stock is listed on The Nasdaq Stock
Market LLC under the symbol PBLA.
Cautionary Statement Regarding Forward-Looking
Statements
This 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,” “design,” “expect,” “feel,”
“intend,” “may,” “plan,” “scheduled,” and “will.” Examples of
forward-looking statements include statements we make regarding
results of collaborations with third parties, future milestones,
and future studies. 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) our ability to
obtain additional funding to execute our business and clinical
development plans; (ii) progress and success of our clinical
development program; (iii) the impact of the current COVID-19
pandemic on our ability to conduct our clinical trials; (iv) our
ability to demonstrate the safety and effectiveness of our product
candidates: SBP-101 and eflornithine (v) our reliance on a third
party for the execution of the registration trial for our product
candidate Flynpovi; (vi) our ability to obtain regulatory approvals
for our product candidates, ivospemin (SBP-101) and eflornithine
(CPP-1X) in the United States, the European Union or other
international markets; (vii) the market acceptance and level of
future sales of our product candidates, ivospemin (SBP-101) and
eflornithine (CPP-1X); (viii) the cost and delays in product
development that may result from changes in regulatory oversight
applicable to our product candidates, ivospemin (SBP-101) and
eflornithine (CPP-1X); (ix) the rate of progress in establishing
reimbursement arrangements with third-party payors; (x) the effect
of competing technological and market developments; (xi) the costs
involved in filing and prosecuting patent applications and
enforcing or defending patent claims; and (xii) such other factors
as discussed 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)
479-1196IR@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, |
|
Six months ended June 30, |
|
|
2022 |
|
2021 |
|
Percent Change |
|
2022 |
|
2021 |
|
Percent Change |
Operating
expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
General and administrative |
|
$ |
1,258 |
|
|
$ |
1,241 |
|
|
1.4 |
% |
|
$ |
3,053 |
|
|
$ |
2,391 |
|
|
27.7 |
% |
Research and development |
|
|
20,028 |
|
|
|
985 |
|
|
1933.3 |
% |
|
|
22,236 |
|
|
|
2,084 |
|
|
967.0 |
% |
Operating loss |
|
|
(21,286 |
) |
|
|
(2,226 |
) |
|
856.2 |
% |
|
|
(25,289 |
) |
|
|
(4,475 |
) |
|
465.1 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
Other income
(expense): |
|
|
|
|
|
|
|
|
|
|
|
|
Interest income |
|
|
2 |
|
|
|
0 |
|
|
- |
|
|
|
2 |
|
|
|
- |
|
|
- |
|
Interest expense |
|
|
(16 |
) |
|
|
(4 |
) |
|
300.0 |
% |
|
|
(20 |
) |
|
|
(7 |
) |
|
185.7 |
% |
Other income (expense) |
|
|
(848 |
) |
|
|
(148 |
) |
|
473.0 |
% |
|
|
(536 |
) |
|
|
(269 |
) |
|
99.3 |
% |
Total other income (expense) |
|
|
(862 |
) |
|
|
(152 |
) |
|
467.1 |
% |
|
|
(554 |
) |
|
|
(276 |
) |
|
100.7 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss before
income tax benefit |
|
|
(22,148 |
) |
|
|
(2,378 |
) |
|
831.4 |
% |
|
|
(25,843 |
) |
|
|
(4,751 |
) |
|
443.9 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
Income tax
benefit |
|
|
18 |
|
|
|
192 |
|
|
-90.6 |
% |
|
|
47 |
|
|
|
308 |
|
|
-84.7 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
Net
loss |
|
|
(22,130 |
) |
|
|
(2,186 |
) |
|
912.4 |
% |
|
|
(25,796 |
) |
|
|
(4,443 |
) |
|
480.6 |
% |
Foreign
currency translation adjustment |
|
|
813 |
|
|
|
140 |
|
|
480.7 |
% |
|
|
514 |
|
|
|
239 |
|
|
115.1 |
% |
Comprehensive Loss |
|
$ |
(21,317 |
) |
|
$ |
(2,046 |
) |
|
941.9 |
% |
|
$ |
(25,282 |
) |
|
$ |
(4,204 |
) |
|
501.4 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and
diluted net loss per share |
|
$ |
(1.51 |
) |
|
$ |
(0.22 |
) |
|
586.4 |
% |
|
$ |
(1.84 |
) |
|
$ |
(0.44 |
) |
|
318.2 |
% |
Weighted
average shares outstanding - basic and diluted |
|
|
14,654,102 |
|
|
|
10,092,995 |
|
|
45.2 |
% |
|
|
14,049,910 |
|
|
|
9,989,705 |
|
|
40.6 |
% |
Panbela Therapeutics, Inc.Consolidated
Balance Sheets (unaudited)(In thousands, except share
amounts)
|
|
June 30, 2022 |
|
December 31, 2021 |
ASSETS |
|
(Unaudited) |
|
|
Current
assets: |
|
|
|
|
Cash and cash equivalents |
|
$ |
2,530 |
|
|
$ |
11,867 |
|
Prepaid expenses and other current assets |
|
|
567 |
|
|
|
91 |
|
Income tax receivable |
|
|
359 |
|
|
|
321 |
|
Total
current assets |
|
|
3,456 |
|
|
|
12,279 |
|
Deposits
held for clinical trial costs |
|
|
3,101 |
|
|
|
593 |
|
Total
assets |
|
$ |
6,557 |
|
|
$ |
12,872 |
|
|
|
|
|
|
LIABILITIES
AND STOCKHOLDERS' (DEFICIT) EQUITY |
|
|
|
Current
liabilities: |
|
|
|
|
Accounts payable |
|
$ |
3,211 |
|
|
$ |
640 |
|
Accrued expenses |
|
|
1,274 |
|
|
|
2,020 |
|
Accrued interest payable |
|
|
66 |
|
|
|
- |
|
Notes payable |
|
|
650 |
|
|
|
- |
|
Debt, current portion |
|
|
1,000 |
|
|
|
- |
|
Total
current liabilities |
|
|
6,201 |
|
|
|
2,660 |
|
|
|
|
|
|
Debt, net of current portion |
|
|
5,194 |
|
|
|
- |
|
Total non
current liabilities |
|
|
5,194 |
|
|
|
- |
|
|
|
|
|
|
Total
liabilities |
|
|
11,395 |
|
|
|
2,660 |
|
|
|
|
|
|
Stockholders' (deficit) equity: |
|
|
|
|
Preferred stock, $0.001 par value; 10,000,000 authorized; no shares
issued or outstanding as of June 30, 2022 and December 31,
2021 |
|
|
- |
|
|
|
- |
|
Common stock, $0.001 par value; 100,000,000 authorized; 20,774,045
and 13,443,722 shares issued and outstanding as of June 30, 2022
and December 31, 2021, respectively |
|
|
21 |
|
|
|
13 |
|
Additional paid-in capital |
|
|
76,451 |
|
|
|
66,227 |
|
Accumulated deficit |
|
|
(81,957 |
) |
|
|
(56,161 |
) |
Accumulated comprehensive income |
|
|
647 |
|
|
|
133 |
|
Total
stockholders' (deficit) equity |
|
|
(4,838 |
) |
|
|
10,212 |
|
Total
liabilities and stockholders' (deficit) equity |
|
$ |
6,557 |
|
|
$ |
12,872 |
|
Panbela Therapeutics, Inc.Consolidated
Statements of Cash Flows (unaudited)(In thousands)
|
|
Six Months Ended June 30, |
|
|
2022 |
|
2021 |
Cash
flows from operating activities: |
|
|
|
|
Net loss |
|
$ |
(25,796 |
) |
|
$ |
(4,443 |
) |
Adjustments to reconcile net loss to net cash used in operating
activities: |
|
|
|
Write off of in process research and development (IPR&D) |
|
|
17,737 |
|
|
|
- |
|
Stock-based compensation |
|
|
627 |
|
|
|
616 |
|
Non-cash interest expense |
|
|
13 |
|
|
|
- |
|
Changes in operating assets and liabilities: |
|
|
|
|
Income tax receivable |
|
|
(33 |
) |
|
|
(251 |
) |
Prepaid expenses and other current assets |
|
|
(219 |
) |
|
|
130 |
|
Deposits held for clinical trial costs |
|
|
(2,561 |
) |
|
|
- |
|
Accounts payable |
|
|
2,483 |
|
|
|
484 |
|
Accrued liabilities |
|
|
(931 |
) |
|
|
(194 |
) |
Net cash used in operating activities |
|
|
(8,680 |
) |
|
|
(3,658 |
) |
Cash
flows from investing activities: |
|
|
|
|
Investment in IPR&D |
|
|
(659 |
) |
|
|
- |
|
Cash acquired in merger |
|
|
4 |
|
|
|
- |
|
Net cash used in investing activities |
|
|
(655 |
) |
|
|
- |
|
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 |
|
|
(9,337 |
) |
|
|
(2,617 |
) |
Cash and
cash equivalents at beginning of period |
|
|
11,867 |
|
|
|
9,022 |
|
Cash and
cash equivalents at end of period |
|
$ |
2,530 |
|
|
$ |
6,405 |
|
|
|
|
|
|
Supplemental disclosure of cash flow
information: |
|
|
|
|
Cash paid during period for interest |
|
$ |
7 |
|
|
$ |
7 |
|
|
|
|
|
|
Supplemental Disclosure of non-cash
transactions: |
|
|
|
|
Fair value of common stock, stock options and stock warrants issued
as consideration for asset acquisition |
|
$ |
9,605 |
|
|
$ |
- |
|
|
|
|
|
|
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