ALLR Allarity Therapeutics Inc

 

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): July 21, 2023

 

ALLARITY THERAPEUTICS, INC.

(Exact name of registrant as specified in our charter)

 

Delaware		001-41160		87-2147982
(State or Other Jurisdiction of Incorporation)		(Commission File Number)		(IRS Employer Identification No.)

 

210 Broadway, Suite 201 Cambridge, MA		02139
(Address of Principal Executive Offices)		(Zip Code)

 

(401) 426-4664

(Registrant’s telephone number, including area code)

 

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 communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

☐

Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

☐

Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

☐

Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

Securities registered pursuant to Section 12(b) of the Act:

 

Title of each class		Trading Symbol(s)		Name of each exchange on which registered
Common Stock, par value $0.0001 per share		ALLR		The Nasdaq Stock Market LLC

 

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. ☐

 

 

Item 3.01 Notice of Delisting or Failure to Satisfy a Continued Listing Rule or Standard; Transfer of Listing.

 

(b) The information set forth under Item 5.02 below is incorporated by reference into this Item 3.01.

 

As disclosed below, the Board of Directors (the “Board”) of Allarity Therapeutics, Inc. (the “Company”) has appointed three (3) new independent directors, which will be effective as of August 1, 2023. Upon the effective of such appointments, the Company’s Board will consist of six (6) directors, four (4) of whom are independent, the Audit Committee will consist of three (3) members, all of whom are independent, and the Compensation Committee will consist of three (3) members, all of whom are independent.

 

As disclosed below, on July 21, 2023, Dr. David Roth resigned as a director of the Company and, as a result of his resignation, the Company as of such date had only one independent director on each of the Company’s Board, Audit Committee and Compensation Committee. The Company believes that upon the effectiveness of the appointment of the three (3) new independent directors on August 1, 2023, discussed above and below, such appointments will bring the Company into compliance with Nasdaq Listing Rules 5606(b), 5605(c)(2) and 5605(d)(2).

 

Item 5.02 Departure of Directors or Certain Officers; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers.

 

(b) On July 21, 2023, the Board of the Company received the resignation of Dr. David Roth as director of the Company, effective immediately. Dr. Roth’s resignation is for personal reasons and not due to any disagreement with the Company’s management team or the Company’s Board on any matter relating to the operations, policies or practices of the Company or any issues regarding the Company’s accounting policies or practices.

 

(d) On July 21, 2023, the Board increased the fixed number of authorized directors on the Board from five (5) to seven (7). To fill the vacancies, the Board appointed the following individuals as a director of the Company, effective as of August 1, 2023 (the “New Directors”):

 

Class I Director: Mr. Joe Vazzano, whose term will expire at the Company’s 2026 annual meeting of stockholders or until his respective successors are duly elected and qualified.

 

Class II Director: Dr. Laura Benjamin, whose term will expire at the Company’s 2024 annual meeting of stockholders or until her respective successors are duly elected and qualified.

 

Class III Director: Mr. Robert Oliver, whose term will expire at the Company’s 2025 annual meeting of stockholders or until his respective successors are duly elected and qualified.

 

In connection with the appointment of the New Directors to the Board, the Board has determined that each of the New Directors qualifies as an independent director under the applicable rules of the NASDAQ listing standards and within the meaning of Rule 10A-3(b)(1) of the Securities Exchange Act of 1934, as amended. In addition, concurrent upon their appointment to the Board, Messrs. Vazzano and Oliver were appointed as members of the Board’s Audit Committee and Compensation Committee, and Mr. Oliver and Dr. Benjamin were appointed as members of the Board’s Nominating and Corporate Governance Committee.

 

 

Below are summaries of each of the New Directors’ business experience:

 

Laura Benjamin, Ph.D. Dr. Benjamin is the Founder and currently serves as Chief Executive Officer of OncXerna Therapeutics, Inc. Prior to this role, Dr. Benjamin was a Vice President in Oncology at Eli Lilly, where she led cancer discovery and translational discovery teams in New York and Indianapolis. She worked closely with the clinical teams to support multiple clinical programs, most notably the ramucirumab program from Phase 2 to commercial launch in colorectal, gastric, and non-small cell lung cancers. Additionally, she helped build the cross-functional initiative to discover, test and advance biomarker development in oncology clinical trials across the portfolio. Prior to joining Lilly, Dr. Benjamin spent 10 years as a tenure track professor in the Department of Pathology at Harvard Medical School. During this time, she supported and mentored Ph.D., postdoctoral, and medical students with NIH and foundation grants. When she left Harvard in 2009, Dr. Benjamin was an Associate Professor and was co-Director of the Vascular Biology Center at the Beth Israel Deaconess Medical Center. Both Dr. Benjamin’s postdoctoral work and academic research at Harvard focused on cellular and molecular mechanisms driving cancer, with a particular interest in the role of the microenvironment on cancer progression and response to targeted therapies. Dr. Benjamin received a B.A. in Biology from Barnard College, Columbia University and a Ph.D. in Molecular Biology from the University of Pennsylvania.

 

Robert (Bob) Oliver, M.B.A. Mr. Oliver most recently served as President and CEO of Otsuka America Pharmaceutical, Inc., (OAPI). He was responsible for overseeing OAPI’s diverse and growing product portfolio across the neuroscience, cardiovascular, oncology, and medical device markets. Prior to joining Otsuka, Mr. Oliver was Vice President and Global Business Manager for Oncology at Wyeth (now Pfizer.) In his roles there, Mr. Oliver also provided leadership to the Vaccines Division and Primary Care while eventually assuming responsibility for U.S. Commercial Operations, including Puerto Rico and the Caribbean. He began his career in pharmaceuticals with Johnson & Johnson, holding positions of increasing responsibility in sales, marketing, business operations and corporate management. Mr. Oliver also serves as a member of the Board for Academic Fellows at Eastern University, where he mentors doctoral candidates. Mr. Oliver has extensive board experience in the biopharmaceutical industry, currently serving on boards for Exelixis, PysBio Therapeutics, and Hyalo Technologies. He previously served as Board Chairman for Otsuka Canada Pharmaceutical. Mr. Oliver received a bachelor’s degree from Rutgers University and an M.B.A. degree in Marketing from the Haub School of Business at Saint Joseph’s University, where he now sits on the Pharma Board of Advisors.

 

Joseph Vazzano, CPA. Mr. Vazzano joined Abeona Therapeutics, Inc. (Nasdaq: ABEO) as Chief Financial Officer in March 2022. While at Abeona, Mr. Vazzano has secured multiple equity raises including private placements, a registered direct offering, and at the market transactions. Before joining Abeona, Mr. Vazzano worked at Avenue Therapeutics, Inc. (Nasdaq: ATXI) from August 2017 to January 2022, most recently serving as Avenue’s Chief Financial Officer. During his tenure at Avenue, Mr. Vazzano secured multiple equity financings and served in a leadership role for signing a complex, two-stage acquisition of Avenue with future contingent value rights. Previously, Mr. Vazzano served as Assistant Corporate Controller at Intercept Pharmaceuticals, Inc. (Nasdaq: ICPT) from October 2016 to July 2017, where he helped grow the finance and accounting department during the company’s transition from a development-stage company to a fully integrated commercial organization. Prior to Intercept, Mr. Vazzano has held various finance and accounting roles at Pernix Therapeutics, Inc. and NPS Pharmaceuticals. Mr. Vazzano began his career at KPMG, LLP and has a Bachelor of Science degree in Accounting from Lehigh University and is a Certified Public Accountant in the State of New Jersey.

 

In connection with their appointment as directors of the Company, the New Directors will enter into the Company’s standard form of indemnification agreement. As compensation for the New Directors’ services as an independent director, which is in accordance with the Company’s standard arrangements for non-employee directors, the New Directors will receive an annual retainer fee of $50,000, payable in cash. In addition, each director will be eligible to receive $7,500 for serving as a member of the Audit Committee, $5,000 for serving as a member of the Compensation Committee, $4,500 for serving as a member of the Nominating and Corporate Governance Committee. In addition, the Board will also grant each New Director options to purchase 2,300 shares of common stock a new equity incentive plan at an exercise equal to the closing price of the Company’s common stock on the date of receipt of stockholder approval of a new equity incentive plan, and will be subject to vesting.

 

Except as disclosed in this Current Report on Form 8-K, there are no arrangements or understandings with any other person pursuant to which the New Directors were appointed as a director of the Company. There are also no family relationships between the New Directors and any of the Company’s directors or executive officers. Except as disclosed in this Current Report on Form 8-K, each of the New Directors has no direct or indirect material interest in any transaction required to be disclosed pursuant to Item 404(a) of Regulation S-K.

 

A copy of the Company’s press release announcing the appointment of the New Directors is attached as Exhibit 99.1 to this Current Report on Form 8-K.

 

 

Item 9.01 Financial Statements and Exhibits

 

(d) Exhibits

 

Exhibit		Exhibit Description
99.1		Press Release dated July 24, 2023
104		Cover Page Interactive Data File (embedded within the Inline XBRL document)

 

 

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.

 

	Allarity Therapeutics, Inc.
	By:	/s/ James G. Cullem
		James G. Cullem
		Chief Executive Officer
Dated: July 27, 2023

 

 

 

 

 

 

 

 

 

 

Exhibit 99.1

 

 

Allarity Therapeutics Strengthens Board of Directors with Appointment of Three Accomplished Biotechnology Executives

 

-

New appointments bring therapeutic development expertise and proven leadership to support continued progress of Allarity’s multiple oncology clinical programs

 

BOSTON (July 24, 2023) — Allarity Therapeutics, Inc. (Allarity or the Company), a clinical-stage pharmaceutical company developing novel oncology therapeutics together with drug-specific DRP^® companion diagnostics for personalized cancer care, today announced the appointment of three seasoned biotechnology executives, Laura Benjamin, Ph.D., Robert Oliver, M.B.A., Joseph Vazzano, C.P.A., to its Board of Directors, effective August 1, 2023.

 

The appointment of these new Board Directors, which fills existing vacancies, completes the Company’s restructuring of its Board, following listing on NASDAQ in late 2021. Additionally, the appointment of these independent Directors is expected to bring the Company back into compliance with the Nasdaq Stock Market’s continued listing requirements relating to Board and Committee independence.

 

"We are thrilled to welcome Dr. Benjamin, Mr. Oliver, and Mr. Vazzano to our Board of Directors," said Jerry McLaughlin, Allarity's Chairman of the Board. "Their combined expertise, industry knowledge, and diverse backgrounds will strengthen our Board's strategic guidance for Allarity. Their appointment results in the assembly of a highly qualified and experienced Board to support the Company’s development efforts towards clinical, and ultimately commercial, success."

 

Laura Benjamin, Ph.D.

 

Laura is the Founder and currently serves as Chief Executive Officer of OncXerna Therapeutics, Inc. Prior to this role, Laura was a Vice President in Oncology at Eli Lilly, where she led cancer discovery and translational discovery teams in New York and Indianapolis. She worked closely with the clinical teams to support multiple clinical programs, most notably the ramucirumab program from Phase 2 to commercial launch in colorectal, gastric, and non-small cell lung cancers. Additionally, she helped build the cross-functional initiative to discover, test and advance biomarker development in oncology clinical trials across the portfolio. Prior to joining Lilly, Laura spent 10 years as a tenure track professor in the Department of Pathology at Harvard Medical School. During this time, she supported and mentored Ph.D., postdoctoral, and medical students with NIH and foundation grants. When she left Harvard in 2009, Laura was an Associate Professor and was co-Director of the Vascular Biology Center at the Beth Israel Deaconess Medical Center. Both Laura’s postdoctoral work and academic research at Harvard focused on cellular and molecular mechanisms driving cancer, with a particular interest in the role of the microenvironment on cancer progression and response to targeted therapies. Laura received a B.A. in Biology from Barnard College, Columbia University and a Ph.D. in Molecular Biology from the University of Pennsylvania.

 

 

Robert (Bob) Oliver, M.B.A.

 

Bob most recently served as President and CEO of Otsuka America Pharmaceutical, Inc., (OAPI). He was responsible for overseeing OAPI’s diverse and growing product portfolio across the neuroscience, cardiovascular, oncology, and medical device markets. Prior to joining Otsuka, Bob was Vice President and Global Business Manager for Oncology at Wyeth (now Pfizer.) In his roles there, Bob also provided leadership to the Vaccines Division and Primary Care while eventually assuming responsibility for U.S. Commercial Operations, including Puerto Rico and the Caribbean. He began his career in pharmaceuticals with Johnson & Johnson, holding positions of increasing responsibility in sales, marketing, business operations and corporate management. Bob also serves as a member of the Board for Academic Fellows at Eastern University, where he mentors doctoral candidates. Bob has extensive board experience in the biopharmaceutical industry, currently serving on boards for Exelixis, PysBio Therapeutics, and Hyalo Technologies. He previously served as Board Chairman for Otsuka Canada Pharmaceutical. Bob received a bachelor’s degree from Rutgers University and an M.B.A. degree in Marketing from the Haub School of Business at Saint Joseph’s University, where he now sits on the Pharma Board of Advisors.

 

Joseph Vazzano, CPA

 

Joseph (Joe) Vazzano joined Abeona Therapeutics, Inc. (Nasdaq: ABEO) as Chief Financial Officer in March 2022. While at Abeona, Mr. Vazzano has secured multiple equity raises including private placements, a registered direct offering, and at the market transactions.  Before joining Abeona, Mr. Vazzano worked at Avenue Therapeutics, Inc. (Nasdaq: ATXI) from August 2017 to January 2022, most recently serving as Avenue’s Chief Financial Officer. During his tenure at Avenue, Mr. Vazzano secured multiple equity financings and served in a leadership role for signing a complex, two-stage acquisition of Avenue with future contingent value rights. Previously, Mr. Vazzano served as Assistant Corporate Controller at Intercept Pharmaceuticals, Inc. (Nasdaq: ICPT) from October 2016 to July 2017, where he helped grow the finance and accounting department during the company’s transition from a development-stage company to a fully integrated commercial organization. Prior to Intercept, Mr. Vazzano has held various finance and accounting roles at Pernix Therapeutics, Inc. and NPS Pharmaceuticals.  Mr. Vazzano began his career at KPMG, LLP and has a Bachelor of Science degree in Accounting from Lehigh University and is a Certified Public Accountant in the State of New Jersey.

 

About Allarity Therapeutics 

 

Allarity Therapeutics, Inc. (Nasdaq: ALLR) develops drugs for personalized treatment of cancer guided by its proprietary and highly validated companion diagnostic technology, the DRP^® platform. The Company has a mature portfolio of three drug candidates: stenoparib, a PARP inhibitor in Phase 2 development for ovarian cancer, and in Phase 1 development for advanced solid tumors in a combination treatment with dovitinib, a pan-tyrosine kinase inhibitor (pan-TKI) that has previously been developed through Phase 3 in renal cancer; and IXEMPRA^® (Ixabepilone), a microtubule inhibitor approved in the U.S. and marketed by R-PHARM U.S. for the treatment of second-line metastatic breast cancer, currently in Phase 2 development in Europe for the same indication. Additionally, the Company has rights in two secondary assets: 2X-111, a liposomal formulation of doxorubicin for metastatic breast cancer and/or glioblastoma multiforme (GBM), which is the subject of discussions for a restructured out-license to Smerud Medical Research International AS; and LiPlaCis^®, a liposomal formulation of cisplatin and its accompanying DRP^®, being developed via a partnership with CHOSA Oncology AB for late-stage metastatic breast cancer. The Company is headquartered in the United States and maintains an R&D facility in Hoersholm, Denmark. For more information, please visit the Company’s website at www.Allarity.com.

 

 

About the Drug Response Predictor – DRP^® Companion Diagnostic 

 

Allarity uses its drug-specific DRP^® to select those patients who, by the genetic signature of their cancer, are found to have a high likelihood of responding to the specific drug. By screening patients before treatment, and only treating those patients with a sufficiently high DRP^® score, the therapeutic response rate can be significantly increased. The DRP^® method builds on the comparison of sensitive vs. resistant human cancer cell lines, including transcriptomic information from cell lines combined with clinical tumor biology filters and prior clinical trial outcomes. DRP^® is based on messenger RNA from patient biopsies. The DRP^® platform has proven its ability to provide a statistically significant prediction of the clinical outcome from drug treatment in cancer patients in 37 out of 47 clinical studies that were examined (both retrospective and prospective), including ongoing, prospective Phase 2 trials of Stenoparib and IXEMPRA^®. The DRP^® platform, which can be used in all cancer types and is patented for more than 70 anti-cancer drugs, has been extensively published in peer-reviewed literature.

 

Follow Allarity on Social Media

 

LinkedIn: https://www.linkedin.com/company/allaritytx/

 

Twitter: https://twitter.com/allaritytx

 

Forward-Looking Statements 

 

This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements provide Allarity’s current expectations or forecasts of future events. The words “anticipates,” “believe,” “continue,” “could,” “estimate,” “expect,” “intends,” “may,” “might,” “plan,” “possible,” “potential,” “predicts,” “project,” “should,” “towards,” “would” and similar expressions may identify forward-looking statements, but the absence of these words does not mean that a statement is not forward-looking. These forward-looking statements include, but are not limited to, statements related to the expected availability of capital to fund its anticipated clinical trials, statements related to advancing dovitinib in combination with stenoparib or another therapeutic candidate or other approved drug, any statements related to ongoing clinical trials for stenoparib as a monotherapy or in combination with another therapeutic candidate for the treatment of advanced ovarian cancer, or ongoing clinical trials (in Europe) for IXEMPRA^® for the treatment of metastatic breast cancer, statements relating to the effectiveness of the Company’s DRP^® companion diagnostics platform in predicting whether a particular patient is likely to respond to a specific drug, and statements related to the Company’s ability to maintain compliance with the Nasdaq Listing Rule. Any forward-looking statements in this press release are based on management’s current expectations of future events and are subject to multiple risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to, the risk that the Company is not able to raise sufficient capital to support its current and anticipated clinical trials, the risk that results of a clinical study do not necessarily predict final results and that one or more of the clinical outcomes may materially change following more comprehensive reviews of the data, and as more patient data become available, the risk that results of a clinical study are subject to interpretation and additional analyses may be needed and/or may contradict such results, the receipt of regulatory approval for dovitinib or any of our other therapeutic candidates or, if approved, the successful commercialization of such products, the risk of cessation or delay of any of the ongoing or planned clinical trials and/or our development of our product candidates, the risk that the results of previously conducted studies will not be repeated or observed in ongoing or future studies involving our therapeutic candidates, and the risk that the current COVID-19 pandemic will impact the Company’s current and future clinical trials and the timing of the Company’s preclinical studies and other operations. For a discussion of other risks and uncertainties, and other important factors, any of which could cause our actual results to differ from those contained in the forward-looking statements, see the section entitled “Risk Factors” in our Form 10-K annual report on file with the Securities and Exchange Commission, available at the Securities and Exchange Commission’s website at  www.sec.gov , and as well as discussions of potential risks, uncertainties and other important factors in the Company’s subsequent filings with the Securities and Exchange Commission. All information in this press release is as of the date of the release, and the Company undertakes no duty to update this information unless required by law.

 

###

Company Contact:
investorrelations@allarity.com

 

U.S. Media Contact:
        Mike Beyer
        Sam Brown, Inc.
        +1 (312) 961-2502
        mikebeyer@sambrown.com
        
EU Media Contact:
        Thomas Pedersen
        Carrotize PR & Communications
        +45 6062 9390

 

 

v3.23.2

Cover	Jul. 21, 2023
Cover [Abstract]
Document Type	8-K
Amendment Flag	false
Document Period End Date	Jul. 21, 2023
Entity File Number	001-41160
Entity Registrant Name	ALLARITY THERAPEUTICS, INC.
Entity Central Index Key	0001860657
Entity Tax Identification Number	87-2147982
Entity Incorporation, State or Country Code	DE
Entity Address, Address Line One	210 Broadway
Entity Address, Address Line Two	Suite 201
Entity Address, City or Town	Cambridge
Entity Address, State or Province	MA
Entity Address, Postal Zip Code	02139
City Area Code	(401)
Local Phone Number	426-4664
Written Communications	false
Soliciting Material	false
Pre-commencement Tender Offer	false
Pre-commencement Issuer Tender Offer	false
Title of 12(b) Security	Common Stock, par value $0.0001 per share
Trading Symbol	ALLR
Security Exchange Name	NASDAQ
Entity Emerging Growth Company	true
Elected Not To Use the Extended Transition Period	false

---