[Form 4] Eyenovia, Inc. Insider Trading Activity

Rhea-AI Filing Summary

On July 8, 2025, Longeveron Inc. (Nasdaq: LGVN) filed a Form 8-K announcing a U.S. FDA clearance of its Investigational New Drug (IND) application for laromestrocel, an allogeneic mesenchymal stem cell therapy derived from young, healthy donor bone marrow. The clearance authorizes the Company to initiate a Phase 2 clinical trial in pediatric dilated cardiomyopathy (DCM), a life-threatening heart condition with limited treatment options. No start-date, enrollment targets, or financial terms were included in the filing. The event represents a key regulatory milestone that advances Longeveron’s lead asset into mid-stage development and broadens its clinical program into the pediatric arena. Aside from the attached press release (Exhibit 99.1), the 8-K contains no additional financial statements, earnings data, or transactional disclosures.

Positive

• FDA clearance of IND enables initiation of Phase 2 trial for laromestrocel in pediatric DCM, marking a significant pipeline advancement.

Negative

• No financial guidance or trial parameters were provided, limiting investors’ ability to assess cost, timeline, and near-term dilution risk.

Insights

Biotechnology Analyst

TL;DR: FDA IND clearance lets LGVN advance laromestrocel into Phase 2 for pediatric DCM—a positive pipeline catalyst, but still early-stage.

The FDA’s go-ahead removes a major regulatory gate, validating pre-clinical data and manufacturing readiness for laromestrocel. Moving into Phase 2 increases asset value because pediatric DCM is an orphan indication with high unmet need, potentially enabling expedited paths such as Rare Pediatric Disease designation. However, the filing lacks trial design details or cash runway information, so investors cannot gauge budget impact or timeline. Overall, this milestone should be viewed as incrementally positive for sentiment and option value of LGVN’s stem-cell platform.

Portfolio Manager

TL;DR: Regulatory milestone raises LGVN’s strategic optionality; financial materiality limited until efficacy data emerge.

From a portfolio perspective, the IND clearance is noteworthy because it de-risks regulatory risk for laromestrocel and positions LGVN for potential partnership discussions. Yet, without disclosed cost estimates or funding plans, the news does not immediately change cash-flow projections. Risk-adjusted valuation moves modestly higher, but the investment case still hinges on forthcoming Phase 2 data quality and capital strategy. I categorize the development as impactful but not transformative at this stage.

SEC Form 4

FORM 4

UNITED STATES SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549

STATEMENT OF CHANGES IN BENEFICIAL OWNERSHIP

Filed pursuant to Section 16(a) of the Securities Exchange Act of 1934
or Section 30(h) of the Investment Company Act of 1940

OMB APPROVAL

OMB Number:			3235-0287
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Check this box if no longer subject to Section 16. Form 4 or Form 5 obligations may continue. See Instruction 1(b).

Check this box to indicate that a transaction was made pursuant to a contract, instruction or written plan for the purchase or sale of equity securities of the issuer that is intended to satisfy the affirmative defense conditions of Rule 10b5-1(c). See Instruction 10.

1. Name and Address of Reporting Person^*

Strahlman Ellen R

(Last) (First) (Middle)

C/O HYPERION DEFI, INC.

23461 SOUTH POINT DRIVE, SUITE 390

(Street)

LAGUNA HILLS CA 92653

(City) (State) (Zip)

2. Issuer Name and Ticker or Trading Symbol
HYPERION DEFI, INC. [ HYPD ]

5. Relationship of Reporting Person(s) to Issuer
(Check all applicable)

X	Director		10% Owner
	Officer (give title below)		Other (specify below)

3. Date of Earliest Transaction (Month/Day/Year)
06/13/2025

4. If Amendment, Date of Original Filed (Month/Day/Year)

6. Individual or Joint/Group Filing (Check Applicable Line)

X	Form filed by One Reporting Person
	Form filed by More than One Reporting Person

Table I - Non-Derivative Securities Acquired, Disposed of, or Beneficially Owned
1. Title of Security (Instr. 3)	2. Transaction Date (Month/Day/Year)	2A. Deemed Execution Date, if any (Month/Day/Year)	3. Transaction Code (Instr. 8)		4. Securities Acquired (A) or Disposed Of (D) (Instr. 3, 4 and 5)			5. Amount of Securities Beneficially Owned Following Reported Transaction(s) (Instr. 3 and 4)	6. Ownership Form: Direct (D) or Indirect (I) (Instr. 4)	7. Nature of Indirect Beneficial Ownership (Instr. 4)
			Code	V	Amount	(A) or (D)	Price
Common Stock, par value $.0001	06/13/2025		A		5,000(1)	A	$0	6,706	D

Table II - Derivative Securities Acquired, Disposed of, or Beneficially Owned (e.g., puts, calls, warrants, options, convertible securities)
1. Title of Derivative Security (Instr. 3)	2. Conversion or Exercise Price of Derivative Security	3. Transaction Date (Month/Day/Year)	3A. Deemed Execution Date, if any (Month/Day/Year)	4. Transaction Code (Instr. 8)		5. Number of Derivative Securities Acquired (A) or Disposed of (D) (Instr. 3, 4 and 5)		6. Date Exercisable and Expiration Date (Month/Day/Year)		7. Title and Amount of Securities Underlying Derivative Security (Instr. 3 and 4)		8. Price of Derivative Security (Instr. 5)	9. Number of derivative Securities Beneficially Owned Following Reported Transaction(s) (Instr. 4)	10. Ownership Form: Direct (D) or Indirect (I) (Instr. 4)	11. Nature of Indirect Beneficial Ownership (Instr. 4)
				Code	V	(A)	(D)	Date Exercisable	Expiration Date	Title	Amount or Number of Shares

Explanation of Responses:

1. These grants vested in full upon the closing of the Company's private placement financing on June 20, 2025.

	/s/ Ellen Strahlman	07/09/2025
	** Signature of Reporting Person	Date
Reminder: Report on a separate line for each class of securities beneficially owned directly or indirectly.
* If the form is filed by more than one reporting person, see Instruction 4 (b)(v).
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FAQ

What did Longeveron (LGVN) announce in its July 8 2025 8-K?

The company disclosed FDA clearance of its IND to start a Phase 2 trial of laromestrocel in pediatric dilated cardiomyopathy.

What is laromestrocel?

Laromestrocel is an allogeneic mesenchymal stem cell product sourced from bone marrow of young, healthy adult donors.

Which indication will the new Phase 2 trial target?

The trial will evaluate laromestrocel as a potential treatment for pediatric dilated cardiomyopathy (DCM).

Were any financial results or guidance included in the filing?

No; the 8-K did not contain earnings figures, budgets, or cash-runway information.

Is this milestone likely to impact LGVN’s near-term revenue?

Not immediately; the clearance only permits trial initiation and does not generate revenue until later clinical stages.