Full Press Release Details
Holdings Reports Fourth Quarter and Full Year Fiscal 2021 Financial and Operating Results and Provides Business Update
expect Rafael Pharmaceuticals to report top line data from its AVENGER 500 Phase 3 registrational clinical trial in metastatic pancreatic
cancer this calendar year
expect to submit our previously announced merger with Rafael Pharmaceuticals to our stockholders for a vote this calendar year
second and final interim futility analysis of Rafael Pharmaceuticals' Phase 3 clinical trial in AML is planned for this calendar
August 24, 2021, we closed a private investment in public equity (PIPE) financing and received net proceeds of approximately $97.8
NEWARK, NJ - October 18, 2021 (GLOBE
NEWSWIRE) - Rafael Holdings, Inc., (NYSE: RFL), is focused on developing novel cancer metabolism therapeutics through its Barer Institute,
investment in Rafael Pharmaceuticals, Inc. ("Rafael Pharmaceuticals"), a privately held, late-stage clinical oncology company
focused on cancer metabolism-based therapeutics, and other early-stage companies, today reported its financial results for the three and
twelve months ended July 31, 2021, and provided a business update.
are pleased to have attracted a team of high caliber experienced senior pharmaceutical executives to lead the critical operational functions
as we prepare for the top line data readout of Rafael Pharmaceuticals' Phase 3 registrational clinical trial for its lead investigational
agent, CPI-613 (devimistat), for the treatment of metastatic pancreatic cancer,
and if results warrant, prepare for an NDA submission," said Ameet Mallik, Chief Executive
Officer of Rafael Holdings, Inc. "We are pleased with the progress across the pipeline, including the ongoing and planned Rafael
Pharmaceuticals' clinical trial programs across multiple indications as well as our early-stage pipeline at the Barer Institute.
Holdings, Inc. (the "Company") Updates
Rafael Pharmaceuticals, Inc. Updates
Holdings, Inc. Fourth Quarter 2021 Financial Results
As of July 31, 2021, we had cash, and cash equivalents of approximately
$7.9 million and a balance in Investments - Hedge Funds valued at $5.3 million.
For the three months ended July 31, 2021, we incurred
a net loss of approximately $12.5 million, a loss of $0.75 per share, which includes approximately $5.6 million in non-cash stock-based
compensation. For the same period in the prior year, we incurred a net loss of approximately $5.5 million, or $0.34 per share, which includes
approximately $0.1 million in non-cash stock-based compensation.
revenues for the fourth quarter of fiscal 2021 amounted to approximately $1 million, compared to revenues of approximately $1.2 million
in the fourth quarter of fiscal 2020.
and development expenses were approximately $1.6 million for the three months ended July 31, 2021. For the same period in the prior year,
R&D expenses were approximately $1.1 million.
selling, general and administrative expenses were approximately $12.1 million for the three months ended July 31, 2021, which includes
$5.6 million in non-cash stock-based compensation expense. For the same period in the prior year, SG&A expenses were approximately
$2.8 million. The increase was primarily driven by an increase in non-cash stock-based compensation expense, increased payroll expense
as we started to build our management team, as well as an increase in legal and professional fees.
Holdings, Inc. Full Year Fiscal 2021 Financial Results
For the twelve months ended July 31, 2021, we incurred
a net loss of $24.8 million, a loss of $1.49 per share, which includes approximately $6.6 million in non-cash stock-based compensation.
For the same period in the prior year, we incurred a net loss of $10.8 million, or $0.66 per share, which includes approximately $0.7
million in non-cash stock-based compensation.
research and development expenses were approximately $4.9 million for the twelve months ended July 31, 2021. For the same period in the
prior year, R&D expenses were approximately $2.4 million. The year over year increase in R&D expenses of approximately $2.5 million
was driven primarily by increased activity at the Barer Institute.
Our selling, general and administrative expenses were approximately
$20.4 million for the twelve months ended July 31, 2021. For the same period in the prior year, SG&A expenses were approximately $9.1
million. The year over year increase of approximately $11.3 million was primarily driven by an increase in non-cash stock-based compensation
expense of $5.9 million, increased payroll expense as we started to build our management team, as well as an increase in legal and professional
Rafael Holdings, Inc.
Holdings is focused on the development of novel cancer therapies. The company owns the Barer Institute and is a significant investor
in two clinical stage oncology companies, Rafael Pharmaceuticals, Inc., and LipoMedix Pharmaceuticals Ltd. Through its wholly owned Barer
Institute subsidiary, the company is developing a pipeline of compounds focused on the regulation of cancer metabolism. On June
21, 2021, we announced that it has entered into a merger agreement to acquire full ownership of Rafael Pharmaceuticals, Inc. For more
information, visit www.rafaelholdings.com.
Rafael Pharmaceuticals, Inc.
Rafael Pharmaceuticals is a clinical-stage oncology
company focused on selectively targeting cancer metabolic pathways while simultaneously harnessing the immune system to attack hard-to-treat
cancers. The Company's lead drug, CPI-613 (devimistat), is being evaluated in multiple clinical studies including
two Phase 3 registrational clinical trials for metastatic pancreatic cancer and r/r acute myeloid leukemia. Multiple Phase 1/2 clinical
trials are ongoing or planned in Biliary, r/r Burkitt, r/r Clear Cell Sarcoma, r/r T-cell lymphoma, r/r MDS, and Colorectal cancer. The
Company's investors include Rafael Holdings, Inc. (NYSE: RFL). For more information, please visit www.rafaelpharma.com.
press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements
contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including
without limitation statements regarding our expectations surrounding the potential, safety, efficacy, and regulatory and clinical progress
of our product candidates; plans and timing for the release of additional clinical data; and the potential of our pipeline, including
our internal cancer metabolism research programs. These statements are neither promises nor guarantees, but involve known and unknown
risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different
from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited
to, the following: the impact of public health threats, including COVID-19, on our business and operations; we depend heavily on the
success of Rafael Pharmaceuticals and the future success of its lead product candidate devimistat (CPI-613 (devimistat)),
and clinical trials of the product candidate may not be successful; our pharmaceutical companies may not be able to develop any medicines
of commercial value; our pharmaceutical companies may not be successful in their efforts to identify or discover potential product candidates;
the manufacturing and manufacturing development of our products and product candidates present technological, logistical and regulatory
risks, each of which may adversely affect our potential revenue; potential unforeseen events during clinical trials could cause delays
or other adverse consequences; risks relating to the regulatory approval process; interim, topline and preliminary data may change as
more patient data become available, and are subject to audit and verification procedures that could result in material changes in the
final data; our product candidates may cause serious adverse side effects; ongoing regulatory obligations; effects of significant competition;
unfavorable pricing regulations, third-party reimbursement practices or healthcare reform initiatives; product liability lawsuits; failure
to attract, retain and motivate qualified personnel; the possibility of system failures or security breaches; risks relating to intellectual
property and significant costs as a result of operating as a public company. These and other important factors discussed under the caption
"Risk Factors" in our Annual Report on Form 10-K for the year ended July 31, 2021, and our other filings with the SEC could
cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such
forward-looking statements represent management's estimates as of the date of this press release. While we may elect to update
such forward-looking statements at some point in the future, we disclaim any obligation to do so, even if subsequent events cause our
RAFAEL HOLDINGS, INC.
CONSOLIDATED BALANCE SHEETS
(audited, in thousands, except share and per share data)
| July 31, | July 31, | |||||||
| 2021 | 2020 | |||||||
| ASSETS | ||||||||
| CURRENT ASSETS | ||||||||
| Cash and cash equivalents | $ | 7,854 | $ | 6,206 | ||||
| Restricted cash | 5,000 | - | ||||||
| Trade accounts receivable, net of allowance for doubtful accounts of $193 and $218 at July 31, 2021 and 2020, respectively | 235 | 267 | ||||||
| Due from Rafael Pharmaceuticals | 600 | 118 | ||||||
| Prepaid expenses and other current assets | 1,075 | 273 | ||||||
| Assets held for sale | 0 | 2,968 | ||||||
| Total current assets | 14,764 | 9,832 | ||||||
| Property and equipment, net | 43,238 | 44,433 | ||||||
| Equity investment - RP Finance | 575 | 192 | ||||||
| Due from RP Finance LLC | 7,500 | - | ||||||
| Investments - Rafael Pharmaceuticals | 79,141 | 70,018 | ||||||
| Investments - Other Pharmaceuticals | 477 | 1,201 | ||||||
| Investments - Hedge Funds | 5,268 | 7,510 | ||||||
| Deferred income tax assets, net | 0 | 6 | ||||||
| In-process research and development and patents | 1,575 | 1,575 | ||||||
| Other assets | 1,517 | 1,580 | ||||||
| TOTAL ASSETS | $ | 154,055 | $ | 136,347 | ||||
| LIABILITIES AND EQUITY | ||||||||
| CURRENT LIABILITIES | ||||||||
| Trade accounts payable | $ | 1,160 | $ | 921 | ||||
| Accrued expenses | 1,227 | 1,191 | ||||||
| Amount due for purchase of membership interest | - | 3,500 | ||||||
| Due to related parties | 136 | - | ||||||
| Notes payable, net of debt issuance costs | 14,528 | - | ||||||
| Other current liabilities | 252 | 115 | ||||||
| Total current liabilities | 17,303 | 5,727 | ||||||
| Other liabilities | 48 | 92 | ||||||
| TOTAL LIABILITIES | 17,351 | 5,819 | ||||||
| COMMITMENTS AND CONTINGENCIES EQUITY | ||||||||
| Class A common stock, $0.01 par value; 35,000,000 shares authorized, 787,163 shares issued and outstanding as of July 31, 2021 and July 31, 2020, respectively | 8 | 8 | ||||||
| Class B common stock, $0.01 par value; 200,000,000 shares authorized, 16,947,066 issued and 16,936,864 outstanding as of July 31, 2021, and 15,034,598 issued and 15,028,536 outstanding as of July 31, 2020 | 169 | 149 | ||||||
| Additional paid-in capital | 159,136 | 129,136 | ||||||
| Accumulated deficit | (40,799 | ) | (16,255 | ) | ||||
| Accumulated other comprehensive income related to foreign currency translation adjustment | 3,772 | 3,762 | ||||||
| Total equity attributable to Rafael Holdings, Inc. | 122,286 | 116,800 | ||||||
| Noncontrolling interests | 14,418 | 13,728 | ||||||
| TOTAL EQUITY | 136,704 | 130,528 | ||||||
| TOTAL LIABILITIES AND EQUITY | $ | 154,055 | $ | 136,347 |
CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except share and per share data)
| (unaudited) | (audited) | |||||||||||||||
| For the three months ended | For the twelve months ended | |||||||||||||||
| 7/31/2021 | 7/31/2020 | 7/31/2021 | 7/31/2020 | |||||||||||||
| Revenues | $ | 969 | $ | 1,240 | $ | 3,971 | $ | 4,910 | ||||||||
| SG&A Expenses | 12,051 | 2,775 | 20,416 | 9,118 | ||||||||||||
| R&D Expenses | 1,562 | 1,064 | 4,907 | 2,391 | ||||||||||||
| Depreciation and amortization | 381 | 453 | 1,460 | 1,866 | ||||||||||||
| Impairment - Altira | - | - | 7,000 | - | ||||||||||||
| Operating Loss | (13,025 | ) | (3,052 | ) | (29,812 | ) | (8,465 | ) | ||||||||
| Unrealized gain on investments | 587 | 1,893 | 4,758 | 2,385 | ||||||||||||
| Other, net | 100 | 505 | 77 | 836 | ||||||||||||
| Loss before Incomes Taxes | (12,538 | ) | (1,664 | ) | (25,131 | ) | (6,916 | ) | ||||||||
| Taxes | (5 | ) | (5 | ) | (18 | ) | (29 | ) | ||||||||
| Impairment of equity method in Altira | - | (4,000 | ) | - | (4,000 | ) | ||||||||||
| Equity in Earnings of RP Finance | 95 | 139 | 383 | 192 | ||||||||||||
| Net loss | (12,448 | ) | (5,530 | ) | (24,766 | ) | (10,753 | ) | ||||||||
| Net loss attributable to noncontrolling interests | (68 | ) | (125 | ) | (222 | ) | (338 | ) | ||||||||
| Net loss attributable to Rafael Holdings, Inc. | $ | (12,380 | ) | $ | (5,405 | ) | $ | (24,544 | ) | $ | (10,415 | ) | ||||
| Loss Per Share | $ | (0.75 | ) | $ | (0.34 | ) | $ | (1.49 | ) | $ | (0.66 | ) | ||||
| Weighted average shares in calculation | 16,522,686 | 15,764,829 | 16,522,686 | 15,764,829 |