Full Press Release Details
Moleculin Biotech, Inc. Reports Financial
Results for the First Quarter Ended March 31, 2017
HOUSTON - May 15, 2017 - Moleculin
Biotech, Inc., (NASDAQ: MBRX) ("Moleculin" or the "Company"), a preclinical pharmaceutical company focused
on the development of anti-cancer drug candidates, some of which are based on license agreements with The University of Texas System
on behalf of the M.D. Anderson Cancer Center ("MD Anderson"), today announced its financial and operating results for
the first quarter ended March 31, 2017 and other recent developments.
First Quarter & Recent Highlights
Planned Activities and Upcoming Potential
| Anticipated Milestone | Potential Timeframe |
| Announcement that our IND for Annamycin has become effective and that we may begin clinical trials | End of July 2017 |
| IRB (Institutional Review Board) approvals and site initiations of various clinical sites participating in our Phase I/II clinical trial of Annamycin | Second Half of 2017 |
| Establishment of a new MTD for Annamycin | Second Half of 2017 |
| A clinician sponsored IND for WP1066 for treatment of adult brain tumors moving forward | Second Half of 2017 |
| Announcement of Phase II data for Annamycin | 2018 |
| Announcement of further benefits of our sponsored research agreement with MD Anderson | 2018 |
Walter Klemp, Chairman and CEO of Moleculin
stated: "We remain focused on developing the CMC data needed to submit our IND to move forward with the FDA by the end of
July and to allow for clinical trials to begin. Additionally, we are pleased to have Theradex
Systems as our CRO for our planned Phase I/II clinical trial for Annamycin. As we transition from a preclinical to a clinical
stage company, we will continue to provide updates on our upcoming key milestones.
We believe we have sufficient funds to pursue our planned operations into the first quarter of 2018."
Unaudited Financial Results for the
Quarter Ended March 31, 2017
Research and development (R&D) expense
was $0.68 million and $0.02 million for the three months ended March 31, 2017 and 2016, respectively. The increase of approximately
$0.66 million is mainly due to the Company becoming fully operational post its June 1, 2016 Initial Public Offering ("IPO").
The difference mainly consists of increases of $0.15 million in sponsored research and research consultants, $0.13 million in employee
related costs, $0.14 million in manufacturing and stability costs associated with the Company's IND application, $0.1 million
in regulatory counsel, $0.07 million in costs associated with the Company's licenses, and $0.07 million of other costs. This
increased activity represents the Company's efforts in obtaining Orphan Drug designation for Annamycin and its associated
IND application with the FDA.
General and administrative ("G&A")
expense was $0.85 million and $0.31 million for the three months ended March 31, 2017 and 2016, respectively. The expense increase
of approximately $0.54 million is mainly due to the Company becoming fully operational post its June 1, 2016 IPO. Specifically,
these increases were attributable to $0.25 million associated with added headcount and associated payroll costs, $0.23 million
in legal, auditing, and accounting costs, and $0.06 million in other G&A costs.
The Company recorded a gain of $1.06 million
in the first quarter of 2017 for the change in fair value on revaluation of its warrant liability associated with the warrants
issued in conjunction with its stock offering on February 14, 2017. The Company is required to revalue certain of its 2017 warrants
at the end of each reporting period and reflect in the statement of operations a gain or loss from the change in fair value of
the warrant in the period in which the change occurred. A gain results principally from a decline in the Company's share
price during the period and a loss results principally from an increase in the Company's share price.
During the period, the Company settled
a previously incurred expense utilizing shares of its common stock with an attributed value of $3.00 per share. The gain of $0.15
million reflects the difference in the Company's share price in the open market as of the settlement date and $3.00 per share.
Interest expense includes expense accrued
on convertible promissory notes issued in 2015 and 2016 bearing interest at the rate of 8% per annum.
The net loss for the three months ended
March 31, 2017 was $0.33 million, which included the non-cash gains mentioned above aggregating to $1.21 million. Excluding this
amount, the net loss for the period was $1.54 million, which is an increase of $1.21 million over the previous years' $0.33
million net loss. Included in both net loss numbers for the three months presented was $0.11 million and $0.00 million for the
2017 and 2016, respectively, in stock based compensation.
As of March 31, 2017, the Company had $8.88
million of cash and cash equivalents compared to $5.00 million at December 31, 2016. In February 2017, Moleculin completed a public
offering of its common stock and warrants, pursuant to which it received approximately $4.5 million in net proceeds, after deducting
underwriting discounts and commissions and estimated offering expenses. Additionally, during the three months ended March 31, 2017,
$0.80 million in cash was received due to warrants being exercised. Cash used in operations was $1.39 million for the first quarter
of 2017. The Company believes that its existing cash and cash equivalents as of March 31, 2017 continues to be sufficient to fund
planned operations into the first quarter of 2018.
About Moleculin Biotech, Inc.
Moleculin Biotech, Inc. is a preclinical
stage pharmaceutical company focused on the development of anti-cancer drug candidates, some of which are based on discoveries
made at M.D. Anderson Cancer Center. Our lead product candidate is Annamycin, an anthracycline for the treatment of relapsed or
refractory acute myeloid leukemia, more commonly referred to as AML. We also have two preclinical small molecule portfolios, one
of which is focused on the modulation of hard-to-target tumor cell signaling mechanisms and the recruitment of the patient's own
immune system. The other portfolio targets the metabolism of tumors.
For more information about the Company,
please visit http://www.moleculin.com.
Forward-Looking Statements
Some of the statements in this release
are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange
Act of 1934 and the Private Securities Litigation Reform Act of 1995, which involve risks and uncertainties. These statements relate
to future events, future expectations, plans and prospects. Forward looking statements in this press release include our IND for
Annamycin becoming effective so that we may begin clinical trials, our ability to receive the necessary IRB approvals to initiate
our Phase I/II clinical trial of Annamycin, our ability to establish a new MTD for Annamycin, the ability of MD Anderson to move
forward with an IND for WP1066 for treatment of adult brain tumors, our ability to announce grant funding for a clinical trial
of WP1066 for treatment of rare childhood brain tumors, and our ability to announce Phase II data for Annamycin. Although Moleculin
believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may
prove to have been materially different from the results expressed or implied by such forward-looking statements. Moleculin has
attempted to identify forward-looking statements by terminology including "believes," "estimates," "anticipates,"
"expects," "plans," "projects," "intends," "potential," "may," "could,"
''might," "will," "should," "approximately" or other words that convey uncertainty of future
events or outcomes to identify these forward-looking statements. These statements are only predictions and involve known and unknown
risks, uncertainties, and other factors, including those discussed under Item 1A. "Risk Factors" in our most recently
filed Form 10-K filed with the Securities and Exchange Commission ("SEC") and updated from time to time in our Form
10-Q filings and in our other public filings with the SEC. Any forward-looking statements contained in this release speak only
as of its date. We undertake no obligation to update any forward-looking statements contained in this release to reflect events
or circumstances occurring after its date or to reflect the occurrence of unanticipated events.
Chief Operating Officer
Moleculin Biotech, Inc.
(in thousands except for par and share amounts)
| March 31, 2017 | December 31, 2016 | |||||||
| (Unaudited) | ||||||||
| Assets | ||||||||
| Current Assets: | ||||||||
| Cash and cash equivalents | $ | 8,881 | $ | 5,007 | ||||
| Prepaid expenses | 269 | 215 | ||||||
| Total current assets | 9,150 | 5,222 | ||||||
| Long-Term Assets: | ||||||||
| Furniture and equipment, net of accumulated depreciation of $10 and $6, respectively | 19 | 23 | ||||||
| Intangible assets | 11,148 | 11,148 | ||||||
| Total Assets | $ | 20,317 | $ | 16,393 | ||||
| Liabilities and Stockholders' Equity | ||||||||
| Current Liabilities: | ||||||||
| Accounts payable and accrued expenses | $ | 858 | $ | 1,069 | ||||
| Convertible notes payable | 108 | 276 | ||||||
| Warrant liability - current portion | 1,238 | - | ||||||
| Total current liabilities | 2,204 | 1,345 | ||||||
| Warrant liability | 1,846 | - | ||||||
| Long-term deferred compensation - related party | 125 | 88 | ||||||
| Total Liabilities | 4,175 | 1,433 | ||||||
| Commitments and contingencies | ||||||||
| Stockholders' Equity: | ||||||||
| Preferred stock, $0.001 par value; 5,000,000 authorized, no shares issued and outstanding | - | - | ||||||
| Common stock, $0.001 par value; 75,000,000 authorized, 17,756,862 and 12,164,852 shares issued and outstanding, respectively | 18 | 12 | ||||||
| Additional paid-in capital | 21,128 | 19,623 | ||||||
| Accumulated deficit | (5,004 | ) | (4,675 | ) | ||||
| Total Stockholders' Equity | 16,142 | 14,960 | ||||||
| Total Liabilities and Stockholders' Equity | $ | 20,317 | $ | 16,393 |
Moleculin Biotech, Inc.
Statements of Operations
(in thousands, except
for share and per share amounts)
| Three Months Ended March 31, | ||||||||
| 2017 | 2016 | |||||||
| Revenue | $ | - | - | |||||
| Operating expenses: | ||||||||
| Research and development | 683 | 15 | ||||||
| General and administrative | 848 | 306 | ||||||
| Depreciation | 4 | _ | ||||||
| Total Operating Expenses | 1,535 | 321 | ||||||
| Loss from operations | (1,535 | ) | (321 | ) | ||||
| Other income (expense): | ||||||||
| Gain from change in fair value of warrant liability | 1,059 | - | ||||||
| Gain from settlement of liability | 149 | - | ||||||
| Other expense | (1 | ) | ||||||
| Interest expense | (1 | ) | (11 | ) | ||||
| Net loss | $ | (329 | ) | $ | (332 | ) | ||
| Net loss per common share - basic and diluted | $ | (0.02 | ) | $ | (0.05 | ) | ||
| Weighted average common shares outstanding - basic and diluted | 14,590,220 | 6,717,767 |