Krystal Biotech announces financial results for the first quarter of 2022 and reports updates on operational progress

Krystal Biotech announces financial results for the first quarter of 2022 and reports updates on operational progress

Kristal Biotech, Inc.

  • Organic product license application for B-VEC continues to apply in the US in Q2 2022 and EU marketing authorization pending in second half of 2022

  • FDA permits home dosing of a patient in B-VEC’s open-label extension study for treatment of DEB

  • Phase 1 positive clinical efficacy results (Pearl-1 study) for KB301 reported by Jeune Aesthetics, Inc., a subsidiary of Krystal Biotech

  • Strong balance sheet, ending the quarter with $ 468.0 million in cash, cash equivalents and investments

PITTSBURGH, 09 May 2022 (GLOBE NEWSWIRE) – Kristal Biotech, Inc.(the “Company”) (NASDAQ: KRYS), a leader in ridosable gene therapy, today released its financial results and key operational progress updates for the first quarter ending March 31, 2022.

“Our primary goal in 2022 is to prepare for the potential approval and launch of B-VEC in the United States,” said Krish S. Krishnan, president and chief executive officer. “We also remain focused on our global B-VEC regulatory documents and advance our strong pipeline and are fortunate to have a team with unwavering commitment and the financial strength to do so.”

Highlights from the program and upcoming events:

B-VEC (beremagene geperpavec) for dystrophic epidermolysis bullosa (“DEB”)

  • On track to file an Organic Product License (“BLA”) application with the US Food and Drug Administration (“FDA”) in Q2 2022 and a Marketing Authorization Application with the European Agency for medicines (“EMA”) in the second half of 2022.

  • New GEM-3 Phase 3 results for B-VEC were presented at the 2022 American Academy of Dermatology Annual Meeting.

  • Following feedback from the FDA, the Company plans to offer DEB patients enrolled in the open label extension study GEM-3 the option to be dosed at home by a healthcare professional. Further details on the study can be found at www.clinicaltrials.gov under the NCT identifier NCT04917887.

  • The results of the Phase 1 and 2 study of B-VEC for the treatment of DEB have been published in Medicine of Nature who provided a comprehensive analysis of the data showing that repeated topical applications of B-VEC were associated with durable wound closure, full-length cutaneous type VII collagen (COL7) expression, and assembly anchoring fibril with minimal reported adverse events.

KB407 for the treatment of cystic fibrosis (“CF”)

  • Phase 1 clinical trial of inhaled KB407 in CF patients in Australia is expected to commence in Q2 2022. Phase 1 study details are available at www.clinicaltrials.gov under the NCT identifier NCT05095246.

  • Anticipate the submission of an investigational application for a new drug (“IND”) and the launch of a Phase 1 clinical trial program in the United States in the second half of 2022.

KB105 for the treatment of autosomal recessive congenital ichthyosis (“ARCI”)

  • The next cohort dosing in the ongoing Phase 1/2 clinical trial of KB105 for the treatment of TGM1-deficient ARC is on track to resume in 2022 and the details of the Phase 1/2 study can be found at www.clinicaltrials.gov under the NCT identifier NCT04047732.

KB104 for Netherton’s syndrome

KB301 for aesthetic indications

  • Jeune Aesthetics, Inc., the wholly owned subsidiary of the Company, announced Positive evidence-of-concept efficacy data from PEARL-1 study cohort 2 on KB301, with study subjects transitioning to enrollment in a durability study to seek duration of effect and long-term safety monitoring term.

  • The complete results of the safety-focused cohort 1 were presented at the 2021 Society for Investigative Dermatology Annual Meeting.

  • Details of the Phase 1 study are available at www.clinicaltrials.gov under the NCT identifier NCT04540900.

Company highlights:

  • Jeune Estetica, Inc. announced its formation and installation of a scientific advisory board, composed of industry leaders to serve as strategic advisors who assist in program strategy and clinical development.

  • In January 2022, Jing Marantz, MD, PhD, MBA resigned from the Board of Directors to accept the position of Chief Business Officer at the Company and E. Rand Sutherland, MD, MPH was named a member of the Board of Directors.

Financial results for the quarter ended March 31, 2022:

  • Cash, cash equivalents and investments amounted to $ 468.0 million as of March 31, 2022.

  • Research and development expenses for the first quarter ending March 31, 2022 were $ 9.3 million, compared to $ 6.2 million in the first quarter of 2021.

  • General and administrative expenses for the first quarter ended March 31, 2022 were $ 15.9 million, compared to $ 8.2 million in the first quarter of 2021.

  • Net losses for the quarters ended March 31, 2022 and 2021 were $ 50.0 million and $ 15.8 million, or $ (1.99) and $ (0.74), respectively, per common share (base and diluted).

  • For more information on the Company’s financial results for the first quarter ending March 31, 2022, please refer to Form 10-Q filed with the SEC.

About Kristal Biotech, Inc.
Krystal Biotech, Inc. (NASDAQ: KRYS) is a critical stage gene therapy company that leverages its proprietary, rideable gene therapy platform and in-house manufacturing capabilities to develop life-changing drugs for patients with severe disease , including rare diseases of the skin, lung and other areas. For more information please visit http://www.krystalbio.comand follow @KrystalBiotech on LinkedIn And Twitter.

About Jeune Aesthetics, Inc.
Jeune Aesthetics, Inc., a 100% subsidiary of Krystal Biotech, Inc., is a biotech company that leverages a clinically validated gene delivery platform to develop products to fundamentally address – and reverse – the biology of aging and / or damaged skin. For more information please visit http://www.jeuneinc.com.

Forward-Looking Statements
Any statements contained in this press release about the expectations, plans and future prospects for Krystal Biotech, Inc., including statements about the clinical utility of B-VEC, the home dosing, the timing of the Company’s submission of the BLA, and the EMA Marketing Authorization Application, the timing of the KB407 Phase 1 clinical trial program in Australia and the United States, the dosing timing of the next cohort in the ongoing Phase 1/2 clinical trial on KB105, the timing of an IND request for KB104 and other statements containing the words “anticipate”, “believe”, “estimate”, “expect”, “intend”, “may”, “plan”, “foresee”, “project”, “target”, “potential”, “probable”, “would”, “would,” “could”, “should”, “continue” and similar expressions constitute forward-looking statements under the Private Securities Litigation Reform Act of 1995. The results actual may differ substantially from those indicated by such forward-looking statements as a result of various important factors, including: uncertainties associated with regulatory review of clinical trials and marketing approval applications, the availability or commercial potential of candidate products, including the B-VEC, the adequacy of cash resources and the need for additional funding and other important factors noted in the caption “Risk Factors” in the Company’s annual and quarterly reports filed with the US Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent the views of the Company as of the date of this release. The Company expects that subsequent events and developments will result in a change in its views. However, although the Company may decide to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing the views of the Company at any time after the date of this release.

CONTACTS:
Investors and media:
Meg Dodge
Biotechnological Crystal
mdodge@krystalbio.com

Source: Kristal Biotech, Inc.

Consolidated balance sheet data:

(In thousands)

31 March
2022

December 31st
2021

Balance sheet data:

Cash and cash equivalents

$

269.303

$

341.246

short-term investments

165,329

96,850

Long-term investments

33,339

64,371

Total assets

616.874

626.295

Total passivity

68.320

32,719

Total equity

$

548.554

$

593.576

Consolidated income statement:

Three months ended March 31st

(In thousands, excluding shares and data per share)

2022

2021

Modify

Expenses

Research and development

$

9,314

$

6.201

$

3.113

General and administrative

15.908

8.152

7,756

Settlement of the dispute

25,000

25,000

Total operating costs

50.222

14,353

35,869

Loss from operations

(50.222

)

(14,353

)

(35,869

)

Other income (expenses)

Interest and other income, net

257

33

224

Passive interests

(1,492

)

1,492

Total other income (expenses)

257

(1,459

)

1,716

Net loss

$

(49.965

)

$

(15,812

)

$

(34.153

)

Net loss per ordinary share: Basic and diluted

$

(1.99

)

$

(0.74

)

Weighted average ordinary shares
exceptional: basic and diluted

25,114,453

21.253.508

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