[8-K] Krystal Biotech, Inc. Reports Material Event

Rhea-AI Filing Summary

On July 7, 2025, Helius Medical Technologies, Inc. (NASDAQ: HSDT) received formal notice from The Nasdaq Stock Market LLC confirming that it has regained compliance with Nasdaq Listing Rule 5550(b)(1), which requires minimum stockholders’ equity of $2.5 million. The company had already restored compliance with the minimum bid-price rule 5550(a)(2) on June 3, 2025. As a result, Helius now meets all criteria necessary to maintain its listing on the Nasdaq Capital Market.

Under Nasdaq Listing Rule 5815(d)(4)(B), HSDT will be subject to a Mandatory Panel Monitor until July 7, 2026. If the company falls out of equity compliance during this one-year period, it will receive an immediate delist determination without the usual cure period, although it may request a new hearing.

No additional financial results, transactions, or operational updates were provided in this Form 8-K.

Positive

• Regained compliance with Nasdaq’s $2.5 million stockholders’ equity requirement, securing continued listing
• Previously restored compliance with minimum bid-price rule, fully meeting Nasdaq Capital Market standards

Negative

• Company placed under one-year Mandatory Panel Monitor; any future equity shortfall will prompt immediate delisting proceedings
• Filing does not disclose the exact stockholders’ equity figure, limiting visibility into compliance buffer

Insights

Financial Analyst

TL;DR: Listing compliance restored; delisting risk deferred but one-year probation increases vigilance.

Helius’s confirmation of equity compliance removes an immediate overhang that threatened liquidity and institutional ownership constraints. Regaining both the equity and bid-price standards keeps the shares tradable on Nasdaq, a net positive for market perception and access to capital. However, the Mandatory Panel Monitor until July 2026 means any dip below the $2.5 million equity threshold will trigger a delist determination with no grace period, underscoring the company’s limited margin for error. Investors should monitor forthcoming balance-sheet disclosures to ensure equity remains comfortably above the floor. Overall impact is positive, but sustainability of compliance remains a key risk factor.

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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 9, 2025

KRYSTAL BIOTECH, INC.

(Exact name of registrant as specified in its charter)

Delaware

001-38210

82-1080209

(State or other jurisdiction of incorporation)

(Commission File Number)

(IRS Employer Identification Number)

2100 Wharton Street, Suite 701

Pittsburgh, Pennsylvania 15203

(Address of principal executive offices, including Zip Code)

Registrant’s telephone number, including area code: (412) 586-5830

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

KRYS

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 7.01    Regulation FD Disclosure

On July 9, 2025, Krystal Biotech, Inc. (the “Company”) issued a press release announcing the first patient dosed in the Company’s Phase 1/2 trial of KB801 for the treatment of neurotrophic keratitis. In addition, the Company announced in the press release that it would host a conference call and webcast at 8:30 a.m. ET on July 9, 2025, to discuss neurotrophic keratitis, the Company’s KB801 program, and the clinical study design. For purposes of the call and webcast, the Company provided a slide presentation, which is available on the “Investors” section of the Company’s website at www.krystalbio.com. Copies of the press release and the slide presentation are attached hereto as Exhibit 99.1 and Exhibit 99.2, respectively, and are incorporated by reference herein.

The information in this Item 7.01 of this Current Report on Form 8-K and in Exhibits 99.1 and 99.2 attached hereto shall not be (i) deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that section, or (ii) incorporated into any registration statement or other document filed with the Securities and Exchange Commission by the Company, whether made before or after the date hereof, regardless of any general incorporation language in such filing, except as shall be expressly set forth by specific reference in such filing.

Item 9.01    Financial Statements and Exhibits.

(d) Exhibits.

Exhibit No.						Description
99.1						Press Release, dated July 9, 2025
99.2						Slide Presentation, dated July 2025
104						Cover Page Interactive Data file (embedded within the Inline XBRL document)

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

Date: July 9, 2025

KRYSTAL BIOTECH, INC.

By:

/s/ Krish S. Krishnan

Name:

Krish S. Krishnan

Title:

Chairman and Chief Executive Officer

FAQ

What did Helius Medical Technologies (HSDT) announce on July 7, 2025?

The company received confirmation from Nasdaq that it has regained compliance with the $2.5 million stockholders’ equity requirement.

Which Nasdaq rules has HSDT now satisfied?

It meets Listing Rule 5550(b)(1) for equity and had previously met Rule 5550(a)(2) for minimum bid price.

How long will HSDT be monitored by Nasdaq?

The company will be under a Mandatory Panel Monitor until July 7, 2026.

What happens if HSDT falls below the equity requirement during the monitor period?

Nasdaq will issue an immediate delist determination letter without a cure period, though HSDT can request a hearing.

Does this 8-K include any earnings or financial results?

No. The filing only addresses Nasdaq listing compliance; no earnings or other financial data were provided.