PASG Passage Bio 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 26, 2024

 

 

PASSAGE BIO, INC.

(Exact name of registrant as specified in its charter)

 

 

Delaware	001-39231	82-2729751
(State or other jurisdiction of incorporation)	(Commission File Number)	(IRS Employer Identification No.)

 

One Commerce Square 2005 Market Street, 39th Floor Philadelphia, PA	19103
(Address of principal executive offices)	(Zip Code)

 

(267) 866-0311

(Registrant’s telephone number, including area code)

 

N/A

(Former name 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:

 

¨	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, $0.0001 Par Value Per Share	PASG	The Nasdaq Stock Market LLC (Nasdaq Global Select Market)

 

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 x

 

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 1.01.

Entry into Material Definitive Agreement.

 

On July 31, 2024, Passage Bio, Inc. (the “Company”) entered into a series of sublicense agreements (the “Gemma Sublicenses”) with Gemma Biotherapeutics, Inc. (“Gemma”), a newly formed genetic medicines company co-founded by Dr. James Wilson, who also serves as a consultant to the Company as Scientific Advisor, for the outlicense of PBGM01 for the treatment of GM1 gangliosidosis, PBKR03 for the treatment of Krabbe disease, and PBML04 for the treatment of metachromatic leukodystrophy (collectively, the “Outlicensed Programs”). Pursuant to the Gemma Sublicenses, the Company will receive (i) initial payments of $10 million for the purchase of clinical product supply; (ii) up to an additional $10 million contingent on the completion by Gemma of certain business milestones; (iii) up to an additional $114 million in development and commercial milestone payments; and (iv) single digit royalties as a percentage of annual worldwide net sales in exchange for sublicenses to relevant intellectual property, transfer of regulatory dossiers and transfer of clinical trial materials and product supply related to the Outlicensed Programs. Pursuant to the Gemma Sublicenses, Gemma will also be responsible for all payments due to the Trustee of the University of Pennsylvania (“Penn”) under the Company’s research, collaboration and licensing agreement with Penn, as amended (the “Penn Agreement”), related to the Outlicensed Programs. The Company also entered into a transition services agreement with Gemma (the “Transition Services Agreement”), pursuant to which, the Company will provide transitional services at cost to Gemma for a period of up to six months from the effective date, and be entitled to reimbursement for transitional services performed retroactively from March 1, 2024, related to the transfer of the Outlicensed Programs.

 

The Company also entered into a research, collaboration and license agreement with Gemma (the “Gemma Collaboration Agreement”), pursuant to which (i) Gemma will conduct certain preclinical and IND-enabling work for the Company’s active research program in Huntington’s disease and a currently paused research program in Temporal Lobe Epilepsy, which were previously being conducted by Penn under the Penn Agreement, and (ii) Gemma will grant the Company options to conduct new research programs in four new central nervous system (“CNS”) indications.

 

As a result of these agreements, the Company and Penn also amended and restated the Penn Agreement, as of July 31, 2024 (as amended, the “Amended Penn Agreement”) to (i) terminate the Company’s funding of discovery research; (ii) terminate the research and exploratory research programs being conducted by Penn; (iii) terminate the remaining options the Company had to select new research programs in the CNS field; and (iv) terminate the transaction fee due to Penn as a result of certain corporate transactions.

 

The foregoing descriptions of the Gemma Sublicenses, Gemma Collaboration Agreement, Transition Services Agreement and the Amended Penn Agreement are qualified in their entirety by reference to each of the Gemma Sublicenses, the Gemma Collaboration Agreement, the Transition Services Agreement and the Amended Penn Agreement, copies of which the Company intends to file as an exhibit to the Company’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2024.

 

Item 2.02 Results of Operations and Financial Condition.

 

On August 1, 2024, the Company issued a press release announcing the information described in Item 1.01 above. In addition, the preliminary, unaudited amount of the Company’s cash, cash equivalents and marketable securities position as of June 30, 2024, is approximately $91.8 million, which the Company expects, together with the initial payments to be received from the Gemma Sublicenses, will enable it to fund its operating expenses and capital expenditure requirements to the end of the second quarter of 2026. This amount is preliminary, unaudited and may change, was prepared by management and is based on the most current information available to management, and is subject to completion by management of the financial statements as of and for the six months ended June 30, 2024, including completion of the review procedures, final adjustments and other developments that may arise between now and the time the financial results for this period are finalized, and completion of the audit of such financial statements.

 

The information in this Item 2.02, including Exhibit 99.1 to this Current Report on Form 8-K, shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section or Sections 11 and 12(a)(2) of the Securities Act of 1933, as amended (the “Securities Act”). The information contained in this Item 2.02 and in the accompanying Exhibit 99.1 shall not be incorporated by reference into any other filing under the Exchange Act or under the Securities Act, except as shall be expressly set forth by specific reference in such filing.

 

 

Item 5.02.

Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers.

 

On July 26, 2024, Mark Forman, M.D., Ph.D., notified the Company of his decision to resign from his position as the Company’s Chief Medical Officer, effective as of August 2, 2024. Dr. Forman’s decision was not the result of any disagreement with the Company on any matter relating to its operations, policies or practices. The Company has initiated a search for a new Chief Medical Officer.

 

Item 7.01.

Regulation FD Disclosure.

 

On August 1, 2024, the Company announced the appointments of Susan Browne, Ph.D. as Chief Scientific Officer of the Company and Stuart Henderson as Chief Business Officer of the Company, each effective as of August 1, 2024. Dr. Browne has been with the Company since June 2021 and was formerly Senior Vice President, Research & Development. In her recent tenure, she has brought scientific leadership to the clinical and preclinical portfolio. Mr. Henderson has been with the Company since February of 2021 and was formerly our Senior Vice President, Investor Relations and Corporate Development. In this role, Mr. Henderson has forged the Company’s agreements with Gemma and has developed relationships for the company with the investment and financial community. With the contributions of Dr. Browne and Mr. Henderson, the Company has executed a pivot in strategy, focusing on exploring the benefits of elevated progranulin in multiple adult neurodegenerative disorders. 

 

The information in this Item 7.01 shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section or Sections 11 and 12(a)(2) of the Securities Act of 1933, as amended (the “Securities Act”). The information contained in this Item 7.01 shall not be incorporated by reference into any other filing under the Exchange Act or under the Securities Act, except as shall be expressly set forth by specific reference in such a filing.

 

Item 9.01

Financial Statements and Exhibits.

 

(d) Exhibits

 

Exhibit No.		Description
99.1		Passage Bio, Inc. press release dated August 1, 2024
104		Cover Page Interactive Data File (formatted as Inline XBRL).

 

 

SIGNATURE

 

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.

 

	PASSAGE BIO, INC.
Date: August 1, 2024	By:	/s/ Kathleen Borthwick
		Kathleen Borthwick
		Chief Financial Officer

 

 

 

Exhibit 99.1

 

 

 

Passage Bio Out-licenses Three Pediatric Gene Therapy Programs to GEMMA Biotherapeutics and Enters New Research Collaboration

 

Granted exclusive, worldwide rights for the development and commercialization of PBGM01 for GM1 gangliosidosis, PBKR03 for Krabbe disease, and PBML04 for metachromatic leukodystrophy to GEMMA Biotherapeutics, a new company co-founded by Dr. James M. Wilson

 

Entered new strategic research and collaboration agreement with GEMMA Biotherapeutics to advance genetic medicines for CNS indications, including Huntington’s disease

 

Transaction expected to extend operating cash runway to the end of Q2 2026

 

PHILADELPHIA – August 1, 2024 – Passage Bio, Inc. (NASDAQ: PASG), a clinical-stage genetic medicines company focused on improving the lives of patients with neurodegenerative diseases, today announced that it has entered into a series of agreements to out-license its three clinical-stage pediatric lysosomal storage disease programs to GEMMA Biotherapeutics, Inc. (GEMMABio), a newly formed company co-founded by James M. Wilson, M.D., Ph.D. Through the transaction, the company granted GEMMABio exclusive, worldwide rights for the development and commercialization of PBGM01 for the treatment of GM1 gangliosidosis, PBKR03 for the treatment of Krabbe disease, and PBML04 for the treatment of metachromatic leukodystrophy.

 

Under the terms of the out-license agreements, the company will receive initial payments of $10 million for the purchase of clinical product supply and up to an additional $10 million contingent on completion of certain GEMMABio business milestones. The company is also eligible to receive up to an additional $114 million in development and commercial milestones as well as future royalties in exchange for sublicenses to relevant intellectual property and the transfer of clinical trial materials and product supply related to the licensed programs. GEMMABio will assume all remaining financial obligations owed to the University of Pennsylvania for the licensed programs. Passage Bio will also provide certain services in support of the transition of the programs to GEMMABio at cost pursuant to a transition services agreement.

 

"We are excited to have out-licensed our pediatric lysosomal storage disease programs to a company deeply committed to advancing these promising therapies for underserved patient communities,” said Will Chou, M.D., president and chief executive officer of Passage Bio. “This transaction is a key initiative in fulfilling our strategy to focus on advancing our lead asset, PBFT02, in multiple adult neurodegenerative diseases while continuing our preclinical research in high potential CNS indications. We have further extended our cash runway, providing us critical time and resources to continue to generate meaningful clinical data for PBFT02 and explore its potential in additional patient populations.”

 

Additionally, the company entered a new strategic research, collaboration, and license agreement with GEMMA Biotherapeutics. Under this agreement, GEMMABio will undertake specific preclinical and IND-enabling activities for the company’s research program including for Huntington’s disease, which was previously managed by the University of Pennsylvania’s Gene Therapy Program. Furthermore, GEMMABio will provide Passage Bio with options to initiate new research programs in four novel central nervous system (CNS) indications.

 

 

 

 

"By establishing GEMMA Biotherapeutics, we are able to further development of promising genetic medicines for rare patient populations, and we are thrilled to advance the three therapies from Passage Bio, each of which targets a devastating pediatric disease,” said James M. Wilson, M.D., Ph.D. “We also look forward to continuing our research and collaboration efforts with Passage Bio, which will leverage our combined expertise to explore new frontiers in CNS research. Together, we are poised to make a profound impact on the lives of patients around the world.”

 

In connection with the agreements with GEMMABio, Passage Bio amended its strategic collaboration with the University of Pennsylvania’s Gene Therapy Program to discontinue its preclinical research programs, terminate its remaining options to future CNS research programs, and terminate its funding of the discovery research program, effective July 31, 2024.

 

Overall, the net impact of the transaction is expected to extend the company’s operating cash runway to the end of Q2 2026.

 

About Passage Bio

 

Passage Bio (Nasdaq: PASG) is a clinical stage genetic medicines company on a mission to improve the lives of patients with neurodegenerative diseases. Our primary focus is the development and advancement of cutting-edge, one-time therapies designed to target the underlying pathology of these conditions. Passage Bio’s lead product candidate, PBFT02, seeks to treat neurodegenerative conditions, including frontotemporal dementia, by elevating progranulin levels to restore lysosomal function and slow disease progression.

 

To learn more about Passage Bio and our steadfast commitment to protecting patients and families against loss in neurodegenerative conditions, please visit: www.passagebio.com.

 

About GEMMA Biotherapeutics

 

GEMMA Biotherapeutics (“GEMMABio”), a new therapeutics company, will serve as a research and innovation company to speed the research of and global access to life-changing advanced therapies for those living with rare diseases.

 

 

 

 

Forward-Looking Statements

 

This press release contains “forward-looking statements” within the meaning of, and made pursuant to the safe harbor provisions of, the Private Securities Litigation Reform Act of 1995, including, but not limited to: our expectations about timing and execution of anticipated milestones, including the receipt of future payments under the GEMMABio agreements; our expectations about GEMMABio’s ability to execute key initiatives; our expectations about cash runway; and the ability of our product candidates to treat their respective target CNS disorders. These forward-looking statements may be accompanied by such words as “aim,” “anticipate,” “believe,” “could,” “estimate,” “expect,” “forecast,” “goal,” “intend,” “may,” “might,” “plan,” “potential,” “possible,” “will,” “would,” and other words and terms of similar meaning. These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements, including: our ability to develop and obtain regulatory approval for our product candidates; the timing and results of preclinical studies and clinical trials; risks associated with clinical trials, including our ability to adequately manage clinical activities, unexpected concerns that may arise from additional data or analysis obtained during clinical trials, regulatory authorities may require additional information or further studies, or may fail to approve or may delay approval of our drug candidates; the occurrence of adverse safety events; the risk that positive results in a preclinical study or clinical trial may not be replicated in subsequent trials or success in early stage clinical trials may not be predictive of results in later stage clinical trials; failure to protect and enforce our intellectual property, and other proprietary rights; our dependence on collaborators and other third parties for the development and manufacture of product candidates and other aspects of our business, which are outside of our full control; risks associated with current and potential delays, work stoppages, or supply chain disruptions; and the other risks and uncertainties that are described in the Risk Factors section in documents the company files from time to time with the Securities and Exchange Commission (SEC), and other reports as filed with the SEC. Passage Bio undertakes no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise.

  

For further information, please contact:

 

Passage Investors:

Stuart Henderson 

Passage Bio 

267.866.0114

shenderson@passagebio.com

 

Passage Bio Media:
Mike Beyer
Sam Brown Inc. Healthcare Communications
312.961.2502
mikebeyer@sambrown.com

 

GEMMA Biotherapeutics: 

Kristen Love

klove@briancom.com

 

 

 

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