Form 8-K - Current report

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): August 7, 2023

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, 39^th 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 ☒

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 2.02 Results of Operations and Financial Condition.

On August 7, 2023, Passage Bio, Inc. (the “Company”) issued a press release (the “Earnings Press Release”) announcing its financial results for the quarter ended June 30, 2023. A copy of the Earnings Press Release is attached as Exhibit 99.1 to this report.

The information in this Item 2.02, including Exhibit 99.1 to this report, 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 7.01 Regulation FD Disclosure.

On August 7, 2023 the Company will host a conference call to discuss interim clinical data from its Imagine-1 Study (the “GM1 Conference Call”) at 8:30AM Eastern Time, and a live webcast of the GM1 Conference Call will be available through the Investor page of the Company’s website.

The information furnished in this Item 7.01 shall not be deemed “filed” for purposes of Section 18 of the Exchange Act, or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference into any other filing under the Securities Act except as expressly set forth by specific reference in such a filing.

Item 8.01 Other Events.

On August 7, 2023, the Company also issued a press release (the “GM1 press release”) and presented a scientific presentation (the “GM1 Presentation”) regarding interim clinical data from its Imagine-1 Study during its GM1 Conference Call. Copies of the GM1 Press Release and GM1 Presentation are attached as Exhibit 99.2 and Exhibit 99.3, respectively, to this report. The GM1 Presentation will also be available on the Company’s website in the Events and Presentations section at www.passagebio.com.

Item 9.01 Financial Statements and Exhibits.

(d)Exhibits


Exhibit No.		Description
99.1		Press release issued by Passage Bio, Inc. regarding its financial results for the quarter ended June 30, 2023, dated August 7, 2023.
99.2		Press release issued by Passage Bio, Inc. regarding interim clinical data from its Imagine-1 Study, dated August 7, 2023.
99.3		Scientific presentation regarding its Imagine-1 Study, dated August 7, 2023.
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 7, 2023	By:	/s/ Kathleen Borthwick
		Kathleen Borthwick
		Interim Chief Financial Officer

Passage Bio Reports Second Quarter 2023 Financial Results and Provides Recent Business Highlights

●

Reported promising interim data from Cohorts 1-4 in the Imagine-1 clinical trial for GM1 gangliosidosis (GM1); PBGM01 continued to have a favorable safety profile and dose-dependent effects on key CSF biomarkers

●

Dose 2 of PBGM01 was able to achieve healthy control levels of CSF β-Gal activity and GM1 gangliosides, with response durable up to 12 months

●

Treated first patient at Dose 3 in Imagine-1 clinical trial in July 2023; initial safety and biomarker data from Dose 3 patients expected by mid-2024

●

Expect to present initial safety and biomarker data from Cohort 1 in global Phase 1/2 upliFT-D trial of PBFT02 for the treatment frontotemporal dementia (FTD) with granulin mutations (GRN) in Q4 2023

●

Execution supported by strong balance sheet, with cash runway to fund operations extended into Q4 2025 following organizational restructuring

PHILADELPHIA – August 7, 2023 – Passage Bio, Inc. (Nasdaq: PASG), a clinical-stage genetic medicines company focused on developing transformative therapies for central nervous system (CNS) disorders, today reported financial results for the second quarter ended June 30, 2023 and provided recent business highlights.

“We continued to make steady progress advancing our lead clinical programs in the second quarter and further improved our financial strength, extending our cash runway into the fourth quarter of 2025. By extending our operating runway, we can continue to focus on strong execution of our GM1 and FTD programs and delivering meaningful clinical data from each program over the coming quarters,” said William Chou, M.D., president and chief executive officer of Passage Bio. “In GM1, we are encouraged by the promising data shared from Cohorts 1 through 4, further validating the potential of PBGM01 as a transformative therapy in both early and late infantile GM1 gangliosidosis. Additionally, we are thrilled to have already dosed the first patient at Dose 3, demonstrating effective execution across the program. In FTD, we are excited by emerging data from initial treated patients, which indicates translation from preclinical models into the clinic. We are experiencing strong momentum in the FTD program with six clinical trial sites in Brazil, Canada, and the United States now initiated, and several GRN positive patients undergoing evaluation for study eligibility. We remain dedicated to progressing our two lead clinical programs in our mission to bring transformative therapies to those affected by devastating CNS disorders.”

Recent Highlights

●

Reported promising interim safety, biomarker and survival data from Cohorts 1-4 of Imagine-1 study: Interim data from eight patients treated in Cohorts 1-4 showed that PBGM01 continued to be well-tolerated and exhibited a favorable safety and immunological profile at both doses tested in early and late infantile GM1. Administration of PBGM01 led to durable and dose-dependent increases in CSF
β-Gal activity, with Dose 2 increasing enzyme activity in three of four patients treated, exceeding average levels seen in healthy controls. Dose 2 PBGM01 also demonstrated the ability to achieve normal levels of CSF GM1 gangliosides at twelve months after treatment (based on a healthy adult reference sample). Additionally, Imagine-1 study participants showed initial evidence of improved survival relative to natural history data.

●

Treated first patient at highest dose level (Dose 3) in Imagine-1 study in July: The company is actively recruiting additional patients in Imagine-1 study to be treated at the highest dose, Dose 3, of PBGM01 in Cohorts 5 (late infantile) and 6 (early infantile). The amended study protocol has been approved at several clinical trial sites in multiple countries, including Brazil, Turkey and the United States. Dosing of patients in Cohorts 5 and 6 may occur concurrently, and the company expects to report initial biomarker and safety data from Dose 3 by mid-2024.

●

Experiencing strong momentum in global Phase 1/2 upliFT-D trial of PBFT02 for the treatment of patients with frontotemporal dementia (FTD) with granulin mutations (GRN): The company continues to experience strong momentum across the FTD program, with six clinical trial sites now initiated across Brazil, Canada, and the United States. Patient enrollment is advancing globally with multiple GRN+ patients identified and being evaluated for eligibility. Initial safety and biomarker data from Cohort 1 patients is expected in Q4 2023.

●

Cash runway extended into Q4 2025: Following an organizational restructuring in July and implementation of prudent cash management strategies, the company significantly extended its cash runway into the fourth quarter of 2025. This provides the company with ample resources to deliver on meaningful clinical data from its two ongoing clinical trials.

●

Appointed Dolan Sondhi, Ph.D. to the company’s board of directors: In July 2023, the company announced the appointment of Dolan Sondhi, Ph.D., Professor of Research in the Department of Genetic Medicine at Weill Cornell Medicine, to its board of directors and her appointment to the Nominating and Corporate Governance Committee. Dr. Sondhi is a highly accomplished research scientist with expertise in the development and translation of adeno-associated virus (AAV) gene therapies for genetic disorders, with a particular emphasis on the CNS, including lysosomal storage diseases and neurodegenerative conditions.

Anticipated Upcoming Milestones

●

Present initial safety and biomarker data for Cohort 1 in upliFT-D clinical trial for FTD in Q4 2023.

●

Present initial safety and biomarker data for Dose 3 in Imagine-1 clinical trial for GM1 gangliosidosis by mid-2024.

Second Quarter 2023 Financial Results

●

Cash Position: Cash, cash equivalents and marketable securities were $151.5 million as of June 30, 2023, as compared to $239.3 million as of June 30, 2022. The Company expects current cash, cash equivalents and marketable securities to fund operations into the fourth quarter of 2025.

●

Research and Development (R&D) Expenses: R&D expenses were $17.3 million for the quarter ended June 30, 2023, as compared to $26.8 million as of June 30, 2022.

●

General and Administrative (G&A) Expenses: G&A expenses were $8.1 million for the quarter ended June 30, 2023, as compared to $13.0 million as of June 30, 2022.

●

Net Loss: Net loss was $23.9 million, or a net loss of $0.44 per basic and diluted share, for the quarter ended June 30, 2023, compared to $39.5 million, or a net loss of $0.73 per basic and diluted share, for the same quarter in 2022.

About PBGM01

PBGM01 is an AAV-delivery gene therapy currently being developed for the treatment of infantile GM1, in which patients have mutations in the GLB1 gene causing little or no residual beta-galactosidase enzyme activity and subsequent neurodegeneration. PBGM01 utilizes a next-generation AAVhu68 capsid administered through the cisterna magna to deliver a functional GLB1 gene encoding beta-galactosidase to the brain and peripheral tissues. By increasing beta-galactosidase activity, PBGM01 has the potential to reduce accumulation of toxic GM1 gangliosides and reverse neuronal toxicity, thereby restoring developmental potential. In preclinical models, PBGM01 has demonstrated broad brain distribution and high levels of expression of the beta-galactosidase enzyme in both the CNS and critical peripheral organs, suggesting potential treatment for both the CNS and peripheral manifestations of GM1.

About GM1

GM1, a rare monogenic lysosomal storage disease, is caused by mutations in the GLB1 gene, which encodes the lysosomal enzyme beta-galactosidase (β-gal). Reduced β-gal activity results in the accumulation of toxic levels of GM1 gangliosides in neurons throughout the brain, causing rapidly progressive neurodegeneration. GM1 accumulation also results in progressive damage to other tissues including the heart, liver, and bones and manifests with hypotonia (reduced muscle tone), progressive CNS dysfunction, seizures, and rapid developmental regression. Life expectancy for infants with GM1 ranges from 2-10 years, and infantile GM1 represents approximately 60 percent of the global GM1 incidence of 0.5 to 1 in 100,000 live births.

About Passage Bio

Passage Bio (Nasdaq: PASG) is a clinical stage genetic medicines company on a mission to provide life-transforming therapies for patients with CNS diseases with limited or no approved treatment options. Our portfolio spans pediatric and adult CNS indications, and we are currently advancing clinical programs in GM1 gangliosidosis and frontotemporal dementia and our preclinical pipeline, including programs in amyotrophic lateral sclerosis and Huntington’s disease. Based in Philadelphia, PA, our company has established a strategic collaboration and licensing agreement with the renowned University of Pennsylvania’s Gene Therapy Program to conduct our discovery and IND-enabling preclinical work. Through this collaboration, we have enhanced access to a broad portfolio of gene therapy candidates and future gene therapy innovations that we then pair with our deep clinical, regulatory, manufacturing and commercial expertise to rapidly advance our robust pipeline of optimized gene therapies. As we work with speed and tenacity, we are always mindful of patients who may be able to benefit from our therapies. More information is available at www.passagebio.com.

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 progress of clinical trials and the availability of clinical data from such trials; our expectations about our collaborators’ and partners’ ability to execute key initiatives; our expectations about manufacturing plans and strategies; our expectations about cash runway; and the ability of our lead product candidates to treat their respective target monogenic 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 caused by the coronavirus pandemic; 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.

Passage Bio, Inc.

Balance Sheets


	(Unaudited)
(in thousands, except share and per share data)	June 30, 2023		December 31, 2022
Assets
Current assets:
Cash and cash equivalents	$	30,291	$	34,601
Marketable securities		121,189		155,009
Prepaid expenses and other current assets		1,230		926
Prepaid research and development		915		6,508
Total current assets		153,625		197,044
Property and equipment, net		20,225		22,515
Right of use assets - operating leases		19,413		19,723
Other assets		433		4,267
Total assets	$	193,696	$	243,549
Liabilities and stockholders’ equity
Current liabilities:
Accounts payable	$	3,383	$	4,065
Accrued expenses and other current liabilities		13,161		11,011
Operating lease liabilities		3,326		3,275
Total current liabilities		19,870		18,351
Operating lease liabilities - noncurrent		23,412		23,832
Total liabilities		43,282		42,183

Stockholders’ equity:
Common stock, $0.0001 par value: 300,000,000 shares authorized; 54,745,680 shares issued and outstanding at June 30, 2023 and 54,614,690 shares issued and outstanding at December 31, 2022		5		5
Additional paid-in capital		701,349		694,733
Accumulated other comprehensive income (loss)		(340)		(966)
Accumulated deficit		(550,600)		(492,406)
Total stockholders’ equity		150,414		201,366
Total liabilities and stockholders’ equity	$	193,696	$	243,549

Passage Bio, Inc.

Statements of Operations and Comprehensive Loss

(Unaudited)


	Three Months Ended June 30,				Six Months Ended June 30,
(in thousands, except share and per share data)	2023		2022		2023		2022
Operating expenses:
Research and development	$	17,324	$	26,821	$	34,160	$	53,034
Acquired in-process research and development		—		—		—		1,500
General and administrative		8,064		12,991		27,111		28,090
Loss from operations		(25,388)		(39,812)		(61,271)		(82,624)
Other income (expense), net		1,532		270		3,077		271
Net loss	$	(23,856)	$	(39,542)	$	(58,194)	$	(82,353)
Per share information:
Net loss per share of common stock, basic and diluted	$	(0.44)	$	(0.73)	$	(1.06)	$	(1.52)
Weighted average common shares outstanding, basic and diluted		54,683,817		54,386,318		54,651,488		54,331,340
Comprehensive loss:
Net loss	$	(23,856)	$	(39,542)	$	(58,194)	$	(82,353)
Unrealized gain (loss) on marketable securities		87		(244)		626		(1,165)
Comprehensive loss	$	(23,769)	$	(39,786)	$	(57,568)	$	(83,518)

For further information, please contact:

Investors:

Stuart Henderson

Passage Bio

267.866.0114

shenderson@passagebio.com

Media:

Mike Beyer
Sam Brown Inc. Healthcare Communications
312.961.2502
MikeBeyer@sambrown.com

Passage Bio Announces Promising Interim Clinical Data from First Eight Patients with GM1 Gangliosidosis in Imagine-1 Study

–Interim safety data up to 28 months showed Dose 1 and 2 of PBGM01 were well tolerated and had a favorable safety and immunological profile

–Dose 2 resulted in substantial improvements in key CSF biomarkers and was able to achieve normal levels of CSF β-Gal activity and GM1 gangliosides, similar to healthy controls

–Dose 2 biomarker responses demonstrated durability up to 12 months after treatment

–Imagine-1 study participants showed initial evidence of improved survival relative to natural history data

–Treated first patient at highest dose level, Dose 3, in July; initial safety and biomarker data from Dose 3 expected by mid-2024

–Management to host a conference call and webcast today at 8:30 a.m. ET

PHILADELPHIA, August 7, 2023 — Passage Bio, Inc. (Nasdaq: PASG), a clinical-stage genetic medicines company focused on developing transformative therapies for central nervous system (CNS) disorders, today announced new interim safety, biomarker, and survival data from cohorts 1-4 in the Imagine-1 clinical study. Imagine-1 is a Phase 1/2, global, open-label, dose-escalation study of the AAVhu68 gene therapy PBGM01 delivered by intra-cisterna magna (ICM) injection in six cohorts of pediatric subjects with early and late infantile GM1 Gangliosidosis (GM1). GM1 is a rare, fatal lysosomal storage disease in which mutations in the GLB1 gene result in very low activity of the enzyme beta-galactosidase (β-Gal).

"We are highly encouraged by the compelling data emerging from our Imagine-1 study, with results underscoring the potential of PBGM01 to be a transformative therapy for GM1 patients,” said William Chou, M.D., president and chief executive officer of Passage Bio. “Updated data from the first eight treated patients show that PGBM01 continues to have a favorable safety profile, is well tolerated and shows initial evidence of improved survival relative to what is predicted by the natural history of the disease. Furthermore, Dose 2 of PBGM01 has shown the ability to achieve healthy control levels of β-Gal activity and GM1 gangliosides in CSF, with durability up to 12 months after treatment.”

“Our momentum in the Imagine-1 study continues to be strong as the program progresses to evaluate its highest dose level, Dose 3, in patients with early and late infantile GM1,” Dr. Chou continued. “We are excited to share that we have treated the first patient at Dose 3, and we are actively recruiting additional patients at clinical trial sites across multiple countries. We look forward to sharing initial data from Dose 3 patients by mid-2024 and want to express our deepest gratitude for the dedication and collaboration demonstrated by the families and investigators who have participated in our Imagine-1 trial.”

Topline interim results from cohorts 1-4 of the Imagine-1 study

Safety (patient follow-up ranged from 8 to 28 months)

●

No treatment-related serious adverse events (SAEs)

●

All treatment-related adverse events (AEs) were mild to moderate in severity

●

No clinically significant changes in liver function requiring intervention

●

No evidence of dorsal root ganglion (DRG) toxicity in nerve conduction studies

●

No complications related to ICM administration

●

Favorable immunological profile with no clinically significant immune response

Survival

●

Imagine-1 study patients showed initial evidence of improved survival relative to natural history data

o

Natural history data from a meta-analysis of 154 GM1 infants with symptom onset <12 months of age indicates mean survival for infantile GM1 of 18.9 months and no survival beyond 35 monthsⁱ

o

Infantile GM1 patients receiving PBGM01 showed a survival benefit, with one hundred percent survival beyond 20 months of age (n=3)

Biomarkers

●

Dose 2 of PBGM01 resulted in robust and durable increases in CSF β-Gal activity

o

In 3 of 4 children, Dose 2 of PBGM01 resulted in a 4.7-16.1x increase in CSF β-Gal activity at 30 days post-treatment relative to baseline, exceeding average levels seen in healthy adults and GM1 Natural History Study (NHSⁱⁱ)

o

Increased CSF β-Gal activity was able to be sustained for up to 12 months

●

Dose 2 of PBGM01 decreased CSF GM1 ganglioside levels and demonstrated the ability to achieve normal adult levels at one-year post-dose

o

GM1 ganglioside levels continued to decline over time in all patients treated with Dose 2

●

Effects on CSF β-Gal activity and GM1 gangliosides were dose-dependent, with Dose 1 of PBGM01 exhibiting modest effects

The company has treated the first patient at Dose 3 and is actively recruiting additional patients in the Imagine-1 study for Cohort 5 (late infantile) and Cohort 6 (early infantile). The amended study protocol has been approved at several clinical trial sites, including in Brazil, Canada, Turkey and the United States. Dosing of patients in Cohorts 5 and 6 may occur concurrently, and the company expects to report initial safety and biomarker data from Dose 3 by mid-2024.

Conference Call Details

Passage Bio will host a conference call and webcast today at 8:30 a.m. ET. To register for the event, please use the following link. A live audio webcast of the event will be available on the Investors & News section of Passage Bio’s website at investors.passagebio.com. The archived webcast will be available on Passage Bio's website approximately two hours after the completion of the event and for 30 days following the call.

About Imagine-1

Imagine-1 is a Phase 1/2, global, open-label, dose-escalation study of PBGM01 administered by a single injection into the cisterna magna in pediatric subjects with early and late infantile GM1. The clinical program consists of six patient cohorts, with separate dose-escalation cohorts for late infantile GM1 and early infantile GM1. The primary goal of the study is to first assess safety and tolerability and then efficacy of PBGM01 in patients. The U.S. Food and Drug Administration (FDA) has granted PBGM01 Fast Track, Orphan Drug, and Rare Pediatric Disease designations. PBGM01 has also received an Orphan designation from the European Commission.

To learn more about the clinical trial program, please visit ClinicalTrials.gov: NCT04713475.

About PBGM01

About GM1

About Passage Bio

Passage Bio (Nasdaq: PASG) is a clinical-stage genetic medicines company on a mission to provide life-transforming therapies for patients with CNS diseases with limited or no approved treatment options. Our portfolio spans pediatric and adult CNS indications, and we are currently advancing clinical programs in GM1 gangliosidosis and frontotemporal dementia and our preclinical pipeline, including programs in amyotrophic lateral sclerosis and Huntington’s disease. Based in Philadelphia, PA, our company has established a strategic collaboration and licensing agreement with the renowned University of Pennsylvania’s Gene Therapy Program to conduct our discovery and IND-enabling preclinical work. Through this collaboration, we have enhanced access to a broad portfolio of gene therapy candidates and future gene therapy innovations that we then pair with our deep clinical, regulatory, manufacturing and commercial expertise to rapidly advance our robust pipeline of optimized gene therapies. As we work with speed and tenacity, we are always mindful of patients who may be able to benefit from our therapies. More information is available at www.passagebio.com.

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 progress of the Imagine-1 clinical trial and the availability of clinical data from the trial; our expectations about our collaborators’ and partners’ ability to execute key initiatives; our expectations about manufacturing plans and strategies; our expectations about cash runway; and the ability of our lead product candidates to treat their respective target monogenic 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 caused by the coronavirus pandemic; 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:

Investors:

Stuart Henderson

Passage Bio

267.866.0114

shenderson@passagebio.com

Media:

Mike Beyer
Sam Brown Inc. Healthcare Communications
312.961.2502
MikeBeyer@sambrown.com

ⁱ Lang, F. M., Korner, P., Harnett, M., Karunakara, A., & Tifft, C. J. (2020). The natural history of Type 1 infantile GM1 gangliosidosis: A literature-based meta-analysis. Molecular genetics and metabolism, 129(3), 228-235.

ⁱⁱ Based on preliminary data from University of Pennsylvania’s ODC Natural History Study (NHS) (NCT04041102); value range (0.3-1.81 nmol/mL/3hr)

Exhibit 99.3

PBGM01 Study in Infantile GM1 Gangliosidosis Interim Clinical Results from Cohorts 1-4 and Program Update of Imagine-1 Clinical Study August 7, 2023

2 Forward-Looking Statements This presentation includes “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 progress of the Imagine-1 clinical study and the availability of clinical data from the study; our expectations about our collaborators’ and partners’ ability to execute key initiatives; our expectations about manufacturing plans and strategies; our expectations about cash runway; and the ability of our lead product candidates to treat their respective target monogenic 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 caused by the coronavirus pandemic; 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.

3 Executive Summary Mark Forman, M.D., Ph.D.

4 Welcome & Agenda Welcome Will Chou, M.D. Executive Summary Mark Forman, M.D., Ph.D. Imagine-1 Interim Clinical Results and Program Update Samiah Al-Zaidy, M.D. Closing Remarks Will Chou, M.D. Q&A Will Chou, M.D. Chief Executive Officer, Passage Bio Mark Forman, M.D., Ph.D. Chief Medical Officer, Passage Bio Samiah Al-Zaidy, M.D. Vice President, Clinical Development Passage Bio

5 PBGM01 is a Potentially Transformative Therapy for GM1 Gangliosidosis, a Rare, Underserved Disorder GM1 GANGLIOSIDOSIS • Inherited lysosomal storage disease that leads to progressive damage to both the CNS and peripheral tissues • Caused by loss-of-function mutations in the GLB1 gene • No approved disease-modifying therapies OUR APPROACH – PBGM01 • Next-generation, proprietary AAVhu68 capsid • Delivers functional GLB1 transgene encoding β-Gal enzyme to the brain and peripheral tissues through ICM delivery

6 GM1 Gangliosidosis Disease Continuum GM1 Gangliosidosis is a Continuum Disease Severity Residual Enzyme Activity (Serum) Focus of Imagine-1 Trial Negligible to 5% ~ 1– 5% ~ 3 – 10% Type 1 (Early Infantile) Onset <6 months • Hypotonia • Neurodegeneration • Developmental regression • Seizures • Skeletal dysplasia • Survival: <2 years without supportive care Type 2a (Late Infantile) Onset 6–24 months • Developmental plateau, followed by regression • Impaired ambulation • Impaired cognition • Seizures • Survival: 5 to 10 years Type 2b (Juvenile) Onset 2–5 years • Impaired ambulation • Dysarthria • Variable skeletal disease • Decreased cognition • Survival into 2nd decade Disease severity inversely related to residual b-Gal enzyme activity Brunetti-Pierri N., Scaglia F. Mol Genet Metab. 2008;94(4):391-396. Jarnes JR, et al. Mol Genet Metab. 2017;121(2):170-179. Lang FM, et al. Mol Genet Metab. 2020;129(3):228-235. Regier DS, Tifft CJ. Rothermel CE. GLB1-related disorders. In: Adam MP, Ardinger HH, Pagon RA, et al, eds. GeneReviews® [Internet].

7 Key Objectives for Imagine-1 Study Establish Safety Profile of PBGM01 Determine Optimal Dose for Therapeutic Effect Understand PBGM01 Benefit Across Infantile GM1 Patient Populations

8 Promising Interim Data from First 8 Treated Patients Favorable safety profile and well-tolerated Initial evidence of improved survival in study participants Dose-dependent increase in CSF β-Gal activity, with increase sustained up to 12-months post-dose Dose-dependent decrease in β-Gal substrate (GM1 ganglioside) in CSF, with Dose 2 able to achieve healthy control levels

9 Imagine-1 Interim Clinical Results Samiah Al-Zaidy, M.D.

10 Imagine-1: Global Phase 1/2 Trial with PBGM01 COHORT 4 Early Infantile n = 2 DOSE 2 (1.1e11 GC/g)* DOSE 1 (3.3e10 GC/g)* COHORT 2 Late Infantile n = 2 COHORT 3 Early Infantile n = 2 COHORT 1 Late Infantile n = 2 60 days between subject enrollment IDMC review Dosing complete * Genome copies per gram of estimated brain weight Completed dosing of initial four cohorts evaluating two doses in early and late infantile GM1 Trial Design Phase 1/2, multi-center, open-label, dose escalation and confirmatory study Route of Administration Intra-cisterna magna (ICM) Vector AAVhu68 Immunosuppression Low dose steroids for 4 weeks then taper Duration Two years, with rollover into long-term follow-up study Primary Endpoints • Safety and tolerability • Efficacy (confirmatory cohort) Biomarkers • β-Gal activity (CSF & serum) • GM1 gangliosides (CSF) • Other exploratory biomarkers

11 Imagine-1 Baseline Patient Characteristics Patient 1 Patient 2 Patient 3 Patient 4 Patient 5 Patient 6 Patient 7 Patient 8 Diagnosis Late Onset Late Onset Early Onset Late Onset Early Onset Late Onset Early onset Early onset Dose level received Dose 1 Dose 1 Dose 1 Dose 2 Dose 1 Dose 2 Dose 2 Dose 2 Cohort 1 1 3 2 3 2 4 4 Gender Male Male Female Female Male Male Female Male Onset of symptoms (months) 14 12 5 13 birth 12 4 birth Chronological age at baseline (months) 14 31 15 18 6 17 7 6 DBS β-Gal activity (nmol/ml/hr)(1) 0.0 0.2 0.0 0.0 0.1 0.0 0.4 0 Genotype c.601C>T, c.601C>T c.601C>T, c.1733AA>G c.694dupC, c.694dupC c.1370G>A, c.168C>G c.1577dup, c.1577dup c.1733A>G, c.802G>C c.765G>C, c.841C>T c.176G>A, c.176G>A DBS, dry blood spot. 1Lower limit of normal: <5.0 nmol/mL/h..

12 Imagine-1 Study: Cohorts 1-4 Safety & Tolerability No treatment-related serious adverse events (SAEs) All treatment-related adverse events (AEs) were mild-to-moderate in severity No clinically significant changes in liver function requiring intervention No evidence of DRG toxicity, as measured by nerve conduction studies No complications related to ICM administration Favorable immunological profile with no clinically significant immune responses1 PBGM01 was well tolerated and had a favorable safety profile at interim analysis* *Patient follow-up ranges from 8 to 28 months post-dosing as of a data cutoff of June 26, 2023 1 No patients required adjustment to immunosuppression regimen.

13 Initial Evidence of Improved Survival Among Study Participants vs. Natural History * From Lang FM, et al. Mol Genet Metab. 2020;129(3):228-235. Lang et al meta-analysis defined GM1 Type I as disease onset <12 months of age (n=154) 0.0 0.2 0.4 0.6 0.8 1.0 0 10 20 30 40 50 60 Probability of Overall Survival Age (months) Infantile GM1 Survival: Imagine-1 vs. Natural History PBGM01 Natural History* Number of subjects at risk Natural History* 154 139 82 4 0 0 0 Imagine-1 6 6 3 1 1 1 0 Infantile GM1 Natural History: • Mean survival: 18.9 months • No survival beyond 35 months Imagine-1: • 100% survival in subjects > 20 months of age (n=3) that received PBGM01 Key Points

14 Dose 1 Exhibited Modest Effects on Key CSF Biomarkers 0 500 1,000 1,500 2,000 2,500 3,000 3,500 4,000 0 30 60 90 120 150 180 210 240 270 300 330 360 390 420 450 Gangliosides, apparent nM Time (days) Dose 1 GM1 Ganglioside, CSF P1 Late Infantile P2 Late Infantile P3 Early Infantile P5 Early Infantile Late Infantile: Circle Early Infantile: Square Healthy adult mean CSF= Cerebrospinal Fluid 0 1 2 3 4 5 6 0 30 60 90 120 150 180 210 240 270 300 330 360 390 420 450 β-Gal, nmol/mL/3hr Time (days) Dose 1 β-galactosidase, CSF P1 Late Infantile P2 Late Infantile P3 Early Infantile P5 Early Infantile Healthy adult mean GM1 NHS mean b-Gal • Dose 1 PBGM01 resulted in modest (1.5 to 4.8x) increase in CSF b-Gal activity relative to baseline at day 30 • No patients maintained a normal adult level of b-Gal activity Gangliosides • Dose 1 PBGM01 did not result in reduction of GM1 gangliosides • Patient 3 (modest increase in b-Gal activity): increased GM1 ganglioside levels were associated with clinical worsening Key Points – Dose 1

15 Dose 2 Resulted in Robust Increases in CSF b-Gal Activity and Decreases in GM1 Gangliosides 0 200 400 600 0 30 60 90 120 150 180 210 240 270 300 330 360 Gangliosides, apparent nM Time (days) Dose 2 GM1 Ganglioside, CSF P4 Late Infantile P6 Late Infantile P7 Early Infantile P8 Early Infantile β-Gal • In 3 of 4 children, Dose 2 PBGM01 resulted in CSF β-Gal exceeding average levels seen in healthy adults and GM1 Natural History Study (NHS)* − 4.7x to 16.1x increase in CSF β-Gal activity vs. baseline at day 30 (n=3) • Increased CSF β-Gal activity can be sustained for up to 12 months Gangliosides • GM1 gangliosides achieved normal adult levels at 1-year post-dose − Gangliosides continue to decline over time in all patients Healthy adult mean 1. Lang FM et al., Mol Genet Metab.2020;129:228-235; CSF= Cerebrospinal Fluid *Based on preliminary data from University of Pennsylvania’s ODC Natural History Study (NHS) (NCT04041102); value range (0.3-1.81 nmol/mL/3hr) GM1 gangliosides hypothesized to mediate CNS manifestations of disease1 0 1 2 3 4 5 6 0 30 60 90 120 150 180 210 240 270 300 330 360 β-Gal, nmol/mL/3hr Time (days) Dose 2 β-galactosidase, CSF P4 Late Infantile P6 Late Infantile P7 Early Infantile P8 Early Infantile Healthy adult mean GM1 NHS mean Key Points – Dose 2 Late Infantile: Circle Early Infantile: Square

16 Summary AEs=adverse events; ICM=intra-cisterna magna *Based on preliminary data from University of Pennsylvania’s ODC Natural History Study (NHS) (NCT04041102). SAFETY & CLINICAL DATA PBGM01 continues to have a favorable safety profile in both early and late infantile GM1 • No serious AEs related to study treatment • No evidence of DRG toxicity • No complications related to ICM injection PBGM01 shows initial evidence of improved survival vs. historical controls BIOMARKER DATA PBGM01 can achieve healthy control levels of missing enzyme and deleterious substrate • In 3 of 4 patients, Dose 2 resulted in CSF β-Gal activity that exceeded average levels seen in healthy adults and GM1 Natural History Study* • Reduction in GM1 gangliosides following Dose 2 has ability to achieve normal adult levels PBGM01 has demonstrated durability up to 12 months after treatment Dose-dependent pharmacodynamic effects

17 Program Update Samiah Al-Zaidy, M.D.

18 Preclinical Rationale for Dose Escalation • Expectation of further increase in b-Gal activity and improved lysosomal function • Dose 3 (2.2 x 1011 GC/g) maintains safety window to maximum dose tested in NHP toxicology study Advancing Program to Evaluate Higher Dose (Dose 3) Potential for an incremental benefit with dose escalation GLB1 -/- Mice Minimum Effective Dose Study1 ICV Dose (GC): 4.4 x 109 1.3 x 1010 4.4 x 1010 1.3 x 1011 Elevated b-Gal activity – Brain (Fold increase vs normal control*) 0.6 0.8 2.6 3.8 Elevated b-Gal activity – CSF (Fold increase vs normal control*) 1.4 1.4 4.1 6.8 Improved lysosomal function – Brain Reduced LAMP1 staining X ✓ ✓✓ ✓✓✓ GC/g Brain Mass Equivalent 1.1 x 1010 (MED) 3.3 x 1010 1.1 x 1011 3.3 x 1011 Dose 1 Dose 2 Dose 3 *Normal control = age-matched, vehicle-treated GLB1 +/- littermate 1 Assays evaluated at 150 and/or 300 days post-dose Abbreviations: b-Gal, beta-galactosidase; CSF, cerebrospinal fluid; d, day; GC, genome copies; GLB, galactosidase beta-1 gene; ICV, intra-cerebroventricular; MED, minimum effective dose; NHP, non-human primate; NT, not tested Clinical Rationale for Dose Escalation • Absence of dose-limiting toxicities in both Early and Late Infantile GM1 • Dose-dependent increase in CSF b-Gal • Dose-dependent decrease in CSF GM1 gangliosides • Achievement of normal adult levels required 1 year Drug Product Supply • Additional cohorts can leverage existing product inventory Imagine-1 Dose

19 PBGM01 – Amended Protocol Addition of 2 cohorts to explore dose 2x higher than Dose 2 • Concurrent dosing of Early and Late Infantile GM1 • Updated Inclusion/Exclusion Criteria to enroll children with earlier stage of disease Early Infantile: − Decreased age at enrollment from 4-24 months to 1-12 months Late Infantile: − Decreased upper age limit at enrollment from 36 months to 24 months − Added requirement of minimum function of sitting without support • Amended protocol approved in multiple countries including United States, Canada, Brazil and Turkey • Treated first patient at Dose 3 in July, with multiple additional patients being evaluated for study eligibility Cohorts 5 & 6 (Dose 3) Status Update COHORT 4 Early Infantile n = 2 DOSE 2 (1.1e11 GC/g)* DOSE 1 (3.3e10 GC/g)* COHORT 6 Early Infantile (n=3) COHORT 5 Late Infantile (n=3) COHORT 2 Late Infantile n = 2 COHORT 3 Early Infantile n = 2 COHORT 1 Late Infantile n = 2 IDMC review Recruiting Dosing complete 60 days between subject enrollment within a Cohort DOSE 3 (2.2e11 GC/g)*

20 Closing Remarks Will Chou, M.D.

21 Imagine-1 Progressing Well Against Key Study Objectives Establish Safety Profile of PBGM01 Determine Optimal Dose for Therapeutic Effect Understand PBGM01 Benefit Across Infantile GM1 Patient Populations ✓ Favorable safety and immunological profile at Dose 1 & 2 − No SAEs related to study treatment − No evidence of DRG toxicity − No complications related to ICM injection ✓ Dose 2 able to achieve healthy control levels of CSF β-Gal activity and GM1 gangliosides ✓ Biomarker changes were durable for up to 12 months ✓ Dose-dependent preclinical effect translated into clinic Dose 3 has potential to further improve biomarker response and therapeutic effect ✓ PBGM01 shows initial evidence of improved survival vs. historical controls Recent study modifications target patients earlier in disease progression, thereby maximizing the potential for clinical benefit

22 PBGM01 Program Anticipated Next Steps • Treated first patient at Dose 3 in July • Plan to share initial safety and biomarker data from Dose 3 by mid-2024 Complete enrollment of Cohorts 5 and 6 • Analyze data from Cohorts 1-6 to establish safety/tolerability profile and therapeutic potential of each dose Determine optimal dose for confirmatory study • Continued interactions with regulatory authorities as data set matures to align on design of confirmatory study and pathway to Biologics License Application Continue engagement with regulatory authorities

Q&A

Document and Entity Information	Aug. 07, 2023
Cover [Abstract]
Document Type	8-K
Document Period End Date	Aug. 07, 2023
Securities Act File Number	001-39231
Entity Registrant Name	PASSAGE BIO, INC.
Entity Incorporation, State or Country Code	DE
Entity Tax Identification Number	82-2729751
Entity Address, Address Line One	One Commerce Square
Entity Address, Address Line Two	2005 Market Street, 39th Floor
Entity Address, City or Town	Philadelphia
Entity Address, State or Province	PA
Entity Address, Postal Zip Code	19103
City Area Code	267
Local Phone Number	866-0311
Written Communications	false
Soliciting Material	false
Pre-commencement Tender Offer	false
Pre-commencement Issuer Tender Offer	false
Title of 12(b) Security	Common Stock, $0.0001 Par Value Per Share
Trading Symbol	PASG
Security Exchange Name	NASDAQ
Entity Emerging Growth Company	true
Entity Ex Transition Period	false
Entity Central Index Key	0001787297
Amendment Flag	false

N-2	Aug. 07, 2023
Cover [Abstract]
Entity Central Index Key	0001787297
Amendment Flag	false
Securities Act File Number	001-39231
Document Type	8-K
Entity Registrant Name	PASSAGE BIO, INC.
Entity Address, Address Line One	One Commerce Square
Entity Address, Address Line Two	2005 Market Street, 39th Floor
Entity Address, City or Town	Philadelphia
Entity Address, State or Province	PA
Entity Address, Postal Zip Code	19103
City Area Code	267
Local Phone Number	866-0311
Entity Emerging Growth Company	true
Entity Ex Transition Period	false

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