8-K
Rafael Holdings, Inc. (RFL)
UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
8-K
CURRENT
REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): November 21, 2021
RAFAEL
HOLDINGS, INC.
(Exactname of registrant as specified in its charter)
| Delaware | 1-38411 | 82-2296593 |
|---|---|---|
| (Stateor other jurisdictionof Incorporation) | (Commission File Number) | (IRSEmployerIdentification No.) |
| 520 Broad Street<br><br> <br>Newark, New Jersey | 07102 | |
| --- | --- | |
| (Address of principal executive offices) | (Zip Code) |
Registrant’s
telephone number, including area code: 212 658-1450
Not
Applicable
(Formername or former address, if changed since last report.)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):
| ☐ | Written<br>communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
|---|---|
| ☐ | Soliciting<br>material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| --- | --- |
| ☐ | Pre-commencement<br>communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| --- | --- |
| ☐ | Pre-commencement<br>communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
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Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company ☒
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Securities registered pursuant to Section 12(b)-2 of the Exchange Act:
| Title of each class | Trading Symbol | Nameof each exchange on which registered |
|---|---|---|
| Class<br> B common stock, par value $0.1 per share | RFL | New<br> York Stock Exchange |
Item 5.02 Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements ofCertain Officers.
(b) On November 21, 2021, Ameet Mallik resigned as Chief Executive Officer of Rafael Holdings, Inc. (the “Company”), effective January 31, 2022. Mr. Mallik will remain as a director of the Company and will chair the newly-established Transition Committee of the Board of Directors.
On November 21, 2021, the Board of Directors decided that William Conkling will depart as the Company’s Chief Commercial and Business Officer, effective January 31, 2022.
(c) On November 21, 2021, the Company’s Board of Directors (i) elected Howard Jonas, the Company’s Chairman of the Board, as the Company’s Chief Executive Officer, effective February 1, 2022 and (ii) elected Patrick Fabbio, the Company’s Chief Financial Officer, as President in addition to his role as the Chief Financial Officer.
Mr. Jonas, age 65, has served as Chairman of the Board of Directors of the Company since August 17, 2017, and served as Chief Executive Officer from March 8, 2018 through April 30, 2021. Mr. Jonas has been a director of Rafael Pharmaceuticals, Inc. since April 2013 and served as its Chairman of the Board from April 2016 through June 2021. Mr. Jonas founded IDT Corporation (“IDT”) in August 1990, and has served as Chairman of its Board of Directors since its inception. Mr. Jonas served as Chief Executive Officer of IDT from October 2009 through December 2013. Mr. Jonas has served as Chairman of the Board of Directors of Genie Energy Ltd. since January 2011 and served as its Chief Executive Officer from January 2014 until November 2017. Mr. Jonas served as the Chairman of the Board of Zedge, Inc., from June 2016 to November 2016, and as its Vice Chairman of Zedge since November 2016. Mr. Jonas also serves as Chairman of the Board of IDW Media Holdings, Inc., and served as its Chief Executive Officer from February 2019 through April 2020. Mr. Jonas is also the founder and has been President of Jonas Media Group (f/k/a Jonas Publishing) since its inception in 1979. Mr. Jonas received a B.A. in Economics from Harvard University.
Mr. Fabbio, age 54, has served as Chief Financial Officer of the Company since September 2021. Mr. Fabbio has more than 25 years of financial, operational and transactional leadership experience in both publicly traded and privately held life science and pharmaceutical companies. Prior to joining Rafael Holdings, Mr. Fabbio was Chief Financial Officer of WindMIL Therapeutics Inc. (from March 2020 to September 2021). Previously he served as the Chief Financial Officer of Progenics Pharmaceuticals, Inc. (from November 15 to March 2020), electroCore Medical, LLC; Vice President of Finance at NPS Pharmaceuticals, Inc.; Vice President of Finance, Innovation and Growth at Catalent Pharma Solutions Inc.; and Chief Financial Officer at Ikano Therapeutics. His other prior financial positions include roles at Sanofi, UniPath Diagnostics, BioMatrix and Coopers & Lybrand. Mr. Fabbio is a board member of BeyondSpring Therapeutics, Inc.
On March 26, 2018, IDT spun off the Company. In connection with the spin-off, IDT and the Company entered into a Transition Services Agreement, dated March 26, 2018 (the “TSA”), pursuant to which IDT, for which Howard S. Jonas serves as the Chairman of the Board, provides certain services to the Company. Trusts for the benefit of Howard Jonas’ nine children, if aggregated together, own a controlling interest in each of the Company and IDT. The services provided by IDT under the TSA include, but are not limited to: administrative, tax and legal. IDT billed the Company a total of $415,316 under the TSA during Fiscal 2021 and $16,840 for invoices paid by IDT on the Company’s behalf. In addition, during Fiscal 2021, the Company billed IDT $57,506 for real estate advisory services provided to IDT. As of July 31, 2021, the Company owed IDT $182,257.
IDT leases space from the Company at 520 Broad Street, Newark, NJ and in Jerusalem, Israel. IDT leases approximate 80,000 square feet of office space plus parking spaces occupied by IDT at 520 Broad Street, Newark, NJ and approximately 3,600 square feet of office space in Jerusalem, Israel. IDT paid the Company $1.7 million for office rent and parking during Fiscal 2021. As of July 31, 2021, IDT owed the Company $189,053 for office rent and parking.
1
Genie Energy, Ltd. (“Genie”), for which Howard S. Jonas serves as the Chairman of the Board, leases office space from the Company at 520 Broad Street. Trusts for the benefit of Howard Jonas’ nine children, if aggregated together, own a controlling interest in Genie and the Company. Billings for such services totaled approximately $226,199 in Fiscal 2021. The Company charges Genie $26.21 per square foot annually for approximately 8,631 square feet of space. As of July 31, 2021, Genie had no amounts due to the Company.
RafaelPharmaceuticals, Inc.
The Company owns 51% of the outstanding capital stock of Rafael Pharmaceuticals, Inc. (“Rafael Pharma”) (41% of the capital stock on a fully diluted basis (excluding the remainder of the warrants to purchase Rafael Pharma stock held by the Company and its affiliates)). Howard S. Jonas owns an equity interest in Rafael Pharma and Ameet Mallik serves as Chairman of the Board of Rafael Pharma. The following transactions have taken place between the Company and Rafael Pharma:
| ● | The<br>Company provides Rafael Pharma with administrative, finance, accounting, tax and legal services. The Company billed Rafael Pharma $480,000<br>during Fiscal 2021. As of July 31, 2021, Rafael Pharma owed the Company $600,000. |
|---|---|
| ● | Effective<br> September 24, 2021, the Company entered into a Line of Credit Loan Agreement (“Line<br> of Credit Agreement”) with Rafael Pharma, which provides for loan commitments in the<br> amount of $25,000,000. The funds loaned under the Line of Credit Agreement are to be used<br> by Rafael Pharma in accordance with the budget that has been approved by the Company. Of<br> the aggregate amount, $1.9 million was advanced on September 24, 2021 and the remaining amount<br> was funded on October 1, 2021. |
| --- | --- |
| ● | In<br> June 2021, the Company entered into an Agreement and Plan of Merger (the “Merger Agreement”)<br> with RH Merger I, Inc., a Delaware corporation and a wholly-owned subsidiary of the Company,<br> RH Merger II, LLC, a Delaware limited liability company and a wholly-owned subsidiary of<br> the Company and Rafael Pharma, whereby Rafael Pharma will become our wholly-owned limited<br> liability subsidiary. |
| --- | --- |
| ● | On<br> December 7, 2020, the Company entered into a Securities Purchase Agreement (the “SPA”)<br> for the sale of 567,437 shares of the Company’s Class B common stock at a price per<br> share of $22.91 (which was the closing price for the Class B common stock on the New York<br> Stock Exchange on December 4, 2020, the trading day immediately preceding the date of the<br> SPA) for an aggregate purchase price of $13 million. In connection with the purchases, each<br> purchaser was granted warrants to purchase an additional twenty percent (20%) of the shares<br> of Class B common stock purchased by such purchaser. The warrants have an exercise price<br> of $22.91 per share and expire on June 6, 2022. The Company issued warrants to purchase an<br> aggregate of 113,487 shares of Class B common stock. Under the SPA, Genie and IDT, two entities<br> on whose boards of directors Howard Jonas serves, each purchased 218,245 shares of Class<br> B common stock and received warrants to purchase an additional 43,649 shares of Class B Common<br> Stock for an aggregate consideration of $10 million. |
| --- | --- |
| ● | On<br> August 19, 2021, the Company entered into a Securities Purchase Agreement with I9Plus, LLC,<br> an entity affiliated with Howard Jonas, whereby the Company agreed to sell to I9Plus, LLC,<br> an aggregate of 112,561 shares of the Company’s Class B common stock at a purchase<br> price equal to $44.42 per share, which was equal to the closing price of the Company’s<br> Class B Common Stock on the New York Stock Exchange on August 19, 2021, resulting in aggregate<br> gross proceeds to the Company of approximately $5.0 million. |
| --- | --- |
In connection with Mr. Fabbio’s election as President, the Company’s Board of Directors and its Compensation Committee approved an amendment (the “Amended Letter Agreement”) to the Letter Agreement with Mr. Fabbio, dated September 10, 2021 and previously filed with the Securities and Exchange Commission on Form 8-K on September 14, 2021 (the “Original Letter Agreement”), which provides, among other things, the following: (i) all of the options granted to Mr. Fabbio will vest on September 30, 2026; (ii) if Mr. Fabbio’s employment is terminated without cause (as such term is defined the Original Letter Agreement) or resigns for good reason (as such term is defined in the Original Letter Agreement) and upon other conditions set forth in the Amended Letter Agreement, Mr. Fabbio will be entitled to severance in the amount of his base salary for 6 months; and (iii) in the event of termination without cause or resignation with good reason within six months following a Change of Control, Mr. Fabbio will be entitled to severance in the amount of his base salary for 12 months.
2
In addition, subject to approval by the stockholders of the Company’s 2021 Equity Incentive Plan at the Company’s annual meeting of stockholder to be held on January 19, 2022, the Company will grant Mr. Fabbio 363,103 restricted shares of the Company’s Class B Common Stock which shall vest as follows: as to 21.5% on December 21, 2022 (the “Initial Vesting Date”), as to 21.5% in four substantially equal amounts on the first through fourth quarterly anniversaries of the Initial Vesting Date and as to the remaining 57% in eight substantially equal amounts on or about each of the fifth through twelfth quarterly anniversaries of the Initial Vesting Date.
The foregoing summary of the Amended Letter Agreement is qualified in its entirety by reference to the Amended Letter Agreement, a copy of which is filed as Exhibit 10.01 to this report and is incorporated herein by reference.
(e) In connection with Mr. Conkling’s departure, the Company entered into a Termination Agreement providing that Mr. Conkling will receive a bonus of $90,000 in accordance with his employment agreement and a severance payment of $225,000 representing six months of his current base salary.
A copy of the November 22, 2021, press release relating to the above events is attached hereto as Exhibit 99.1 and is incorporated herein by reference.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits.
| Exhibit No. | Document |
|---|---|
| 10.01 | Amended Letter Agreement dated November 22, 2021, between the Company and Patrick Fabbio. |
| 99.1 | Press Release, dated November 22, 2021. |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) |
3
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| RAFAEL HOLDINGS, INC. | ||
|---|---|---|
| By: | /s/ Ameet Mallik | |
| Name: | Ameet Mallik | |
| Title: | Chief Executive Officer |
Dated: November 22, 2021
4
EXHIBIT
INDEX
| Exhibit Number | Document |
|---|---|
| 10.01 | Amended Letter Agreement dated November 22, 2021, between the Company and Patrick Fabbio. |
| 99.1 | Press Release, dated November 22, 2021. |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) |
5
Exhibit 10.01
520 Broad Street
Newark, NJ 07102
November 21, 2021
VIA EMAIL
Patrick Fabbio
Patrick.fabbio@rafaelholdings.com
Dear Pat,
As you are aware, you and Rafael Holdings, Inc. (“Rafael” or the “Company”) entered into a letter agreement dated September 10, 2021 (the “Letter Agreement”) related to your employment by the Company. The purpose of this letter (the “Amendment”) is to amend the Letter Agreement and your terms of employment, effective as of November 21, 2021 (the “Effective Date”), as follows:
As of the Effective Date, you will be the President and Chief Financial Officer of the Company, which shall be an executive officer position with the Company, and in that role you will be responsible for business and financial aspects of the operations of the company and its subsidiaries and controlled affiliates.
The third sentence of Section 5 (Equity) of the Letter Agreement shall be amended to read in its entirety:
The vesting schedule shall be as follows: all Options will vest on September 30, 2026.
- Section 7(c) of the Letter Agreement shall be amended to read in its entirety:
(c) Termination without Cause. Your employment at the Company may be terminated by the Company without Cause upon five (5) business days’ written notice to you in accordance with Section 7(e) below. In the event of the your termination by the Company without Cause: (i) you shall receive the Base Salary and all eligible benefits, in each case through the Date of Termination, (ii) the Company shall have the right to determine whether or not you will actively work for the Company during the notice period, and (iii) provided that you execute and deliver a separation and release agreement in a form acceptable to the Company within twenty-one (21) days after the Date of Termination (unless applicable law requires a longer time period, in which case this date will be extended to the minimum time required by applicable law and such 21-day or extended period, as applicable, the “Release Execution Period”) and do not revoke such agreement, you will receive, as severance pay (A) if your Date of Termination is not within six months following a Change of Control, continuation of your Base Salary for six (6) months or (B) if your Date of Termination is within six months following a Change of Control, continuation of your Base Salary for twelve (12) months, in each case payable, subject to Section 11 hereof, on a prorated basis in accordance with the Company’s regular payroll schedule. You shall not be entitled to any other amounts or benefits from the Company other than as set forth in this Section 7(c).
520 Broad Street, Newark NJ 07102
520 Broad Street
Newark, NJ 07102
- The first paragraph of Section 7(d) of the Letter Agreement shall be amended to read in its entirety:
(d) Resignation by You for Good Reason. Your employment at the Company may be terminated by you for Good Reason if (x) you have given written notice to the Company of the existence of Good Reason no later than thirty (30) days after its initial existence, (y) the Company has not remedied such Good Reason in all material respects within thirty (30) days after its receipt of such written notice, and (z) you provide written notice of your resignation to the Company in accordance with Section 7(e) hereunder within seventy-five (75) days following the initial existence of such Good Reason. In the event of your termination of your employment for Good Reason: (i) you shall receive the Base Salary and all benefits as generally eligible, in each case through the Date of Termination, (ii) the Company shall have the right to determine whether or not you will actively work for the Company during any notice period, and (iii) provided that you execute and deliver a separation and release agreement in a form acceptable to the Company within the Release Execution Period (and do not revoke such agreement), you will receive, as severance pay (A) if your Date of Termination is not within six months following a Change of Control, continuation of your Base Salary for six (6) months or (B) if your Date of Termination is within six months following a Change of Control, continuation of your Base Salary for twelve (12) months, in each case payable, subject to Section 11 hereof, on a prorated basis in accordance with the Company’s regular payroll schedule. You shall not be entitled to any other amounts or benefits from the Company other than as set forth in this Section 7(d).
Except as set forth above, all terms of the Letter Agreement and the schedules thereto, shall remain as written and unchanged.
Restricted Stock. In addition to the foregoing, within thirty (30) days of the approval by the stockholders of the Company of the 2021 Equity Incentive Plan, the Company will grant to you, under such plan, 363103 shares (“Shares”) of Restricted Class stock of the Company. Twenty-one and one half percent (21.5%) of the Shares will vest on December 21, 2022 (the “Initial Vesting Date”). An additional twenty-one and one half percent (21.5%) of the Shares will vest in four substantially equal amounts on or near each of the first through the fourth quarterly anniversaries of the Initial Vesting Date, and the remainder of the Shares will vest in eight substantially equal amounts on or near each of the fifth through the twelfth quarterly anniversaries of the Initial Vesting Date, provided that vesting will be timed to coincide with expected open trading windows under the Company’s Insider Trading policy.
Nothing herein changes the at-will nature of your employment with the Company.
If these terms are acceptable to you, please sign and date this Amendment below and return it to Ameet Mallik at ameet.mallik@rafaelholdings.com
| Very truly yours, | |
|---|---|
| /s/ Ameet Mallik | |
| Chief Executive Officer | |
| AGREED TO AND ACCEPTED BY: | /s/ Patrick Fabbio |
| --- | --- |
| Patrick Fabbio |
DATE: 11/21/21
520 Broad Street, Newark NJ 07102
Exhibit 99.1
Rafael Holdings Realigns Leadership Team to Support Earlier Stage Pipeline Focus
- Ameet Mallik to Transition CEO Role to Chairman, Howard Jonas, and Will Remain a Highly Engaged Member of the Company’s Board of Directors and Chair Newly Established Transition Committee -
- Patrick Fabbio, Chief Financial Officer, to Assume the Additional Role of President -
- Dr. Mimi Huizinga, Chief Medical Officer, to Assume the Additional Role of Head of Research and Development –
NEWARK, NJ – November 22, 2021 (GLOBE NEWSWIRE) -- Rafael Holdings, Inc., (NYSE: RFL), a company focused on developing novel cancer and immune metabolism therapeutics through its Barer Institute and investment in Rafael Pharmaceuticals, Inc. today announced several changes to its leadership team. Ameet Mallik will transition his Chief Executive Officer responsibilities to Chairman, Howard Jonas, as of February 1, 2022, and will remain highly engaged as a member of the Board of Directors of Rafael Holdings. Patrick Fabbio will assume the position of President, in addition to continuing as Chief Financial Officer, with the responsibility to lead the operations and finances of the business. Dr. Mimi Huizinga will continue as Chief Medical Officer and assume additional responsibilities as the Head of Research and Development. She will lead the company’s research, development and medical strategy and operations. To oversee the management transition and the organization’s evolution, the Board has established a Transition Committee, which Ameet will chair.
“I joined Rafael Holdings to recruit a top-tier leadership team to evolve the company into a fully integrated commercial organization. While the recent results of Rafael Pharmaceuticals’ two Phase 3 clinical trials for CPI-613^®^ (devimistat) in metastatic pancreatic cancer and relapsed or refractory acute myeloid leukemia are disappointing, I am proud of and grateful for the team’s significant contributions,” said Ameet Mallik, outgoing CEO and continuing member of the Board. “We are fortunate to have an early-stage pipeline backed by world class scientific advisors, which we believe has great potential. I would like to congratulate Mimi and Pat on their expanded roles, and I have the utmost confidence in their ability to move the company forward.”
With the change in company focus, Rafael Holdings also announced the planned departures of: William Conkling, Chief Commercial and Business Officer; Ashok David Marin, Chief Legal Officer; Brandi Robinson, Chief Corporate Affairs Officer; and Melissa Lozner, Chief Compliance and Ethics Officer. These transitions will take place by the end of January 2022.
“I would like to thank Ameet and the current leadership team for enhancing the capabilities of the company,” said Howard Jonas, Chairman of the Board, Rafael Holdings. “I look forward to Ameet continuing as a member of the Rafael Holdings Board of Directors and to working with Pat and Mimi to advance our research and development efforts. I’m excited about the future of Rafael Holdings and what we will accomplish together.”
Patrick Fabbio most recently served as Chief Financial Officer of the Company and has more than 25 years of financial, operational, and transactional leadership experience in both publicly traded and privately held life science and pharmaceutical companies. Prior to joining Rafael Holdings, Patrick was Chief Financial Officer of WindMIL Therapeutics Inc. Previously he served as the Chief Financial Officer of Progenics Pharmaceuticals, Inc., electroCore Medical, LLC; Vice President of Finance at NPS Pharmaceuticals, Inc.; Vice President of Finance, Innovation and Growth at Catalent Pharma Solutions Inc.; and Chief Financial Officer at Ikano Therapeutics. His other prior financial positions include roles at Sanofi, UniPath Diagnostics, BioMatrix and Coopers & Lybrand. Patrick is a board member of BeyondSpring Therapeutics, Inc.
Dr. Huizinga recently served as Chief Development and Medical Officer of the Company. Prior to joining Rafael Holdings, she was the Head of US Oncology Medical for Novartis, overseeing the clinical development and medical affairs activities of the Novartis oncology portfolio in the US. Before leading the medical function, Dr. Huizinga built and led the strategic data and digital function in the US Oncology business unit at Novartis. The strategic data and digital function included real-world evidence, healthcare economics and clinical and value evidence liaisons in addition to supporting digital marketing and constructing a data strategy and platform. During her time at Novartis, Dr. Huizinga participated in more than a dozen product and indication launches. Prior to Novartis, she was the Chief Health Information Officer at Premier, Inc, where she also led the Applied Sciences division partnering with several pharmaceutical companies around evidence generation needs. Dr. Huizinga has previously served as the VP of Quality at Lifepoint Health, an associate at McKinsey & Company and an Assistant Professor at the Johns Hopkins University. Dr. Huizinga holds an MD and MPH from Vanderbilt University and is a fellow of the American College of Physicians.
About Rafael Holdings, Inc.
Rafael Holdings is focused on the development of novel cancer and immune metabolism therapeutics. The company owns the Barer Institute, Inc. and is a significant investor in two clinical stage oncology companies, Rafael Pharmaceuticals, Inc., and LipoMedix Pharmaceuticals Ltd. Through the Barer Institute, the company is developing a pipeline of compounds focused on the regulation of cancer and immune metabolism. On June 21, 2021, the company announced that it has entered into a merger agreement to acquire full ownership of Rafael Pharmaceuticals, Inc. For more information, visit www.rafaelholdings.com.
About Rafael Pharmaceuticals, Inc.
Rafael Pharmaceuticals is focused on the growing field of cancer metabolism. The company is developing a new category of metabolic oncology therapeutic candidates that are designed to attack hard-to-treat cancers by targeting the metabolic processes that these cancers need to survive, grow, and proliferate. Rafael Pharmaceuticals’ lead compound, CPI-613^®^ (devimistat), is an investigational anti-cancer agent that is being evaluated in ongoing Phase 1, 2 and 3 clinical trials. The Company’s investors include Rafael Holdings, Inc. (NYSE: RFL). On June 21, 2021, Rafael Pharmaceuticals announced that it has entered into a merger agreement with Rafael Holdings, Inc. to create a publicly traded late-stage clinical oncology company focused on cancer metabolism-based therapeutics. For more information, please visit www.rafaelpharma.com.
Forward Looking Statements
This 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 regarding the further evaluation of 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^®^), 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 views to change.
Contact:
Barbara Ryan
Barbara.ryan@rafaelholdings.com
(203) 274-2825