KRINGLE PHARMA, INC. This is a translation of the original document in Japanese prepared for the convenience of readers outside Japan. The
original in Japanese shall prevail in the event of any discrepancies between the translation and the original.
Financial Results for the Nine Months Ended June 30, 2021
[Japanese GAAP] (Non-consolidated)
August 13, 2021
Company name: Kringle Pharma, Inc.
Stock exchange listing: Tokyo Stock Exchange
Code number: 4884
URL: https://www.kringle-pharma.com/en/
Representative: Kiichi Adachi, President & CEO
Contact: Yutaka Matsuura, Member of the Board, Director of Corporate Planning Management
Phone: +81-72-641-8739
Scheduled date of filing quarterly securities report: August 13, 2021
Scheduled date of commencing dividend payments: -
Availability of supplementary explanatory materials on quarterly financial results: Available
Schedule of quarterly financial results briefing session: Scheduled
(Amounts of less than one million yen are rounded down.) | ||||||||||||||||||||||||
1. Financial Results for the Nine Months Ended June 30, 2021 (October 1, 2020 - June 30, 2021) | ||||||||||||||||||||||||
(1) Operating Results | (% indicates changes from the previous corresponding period.) | |||||||||||||||||||||||
Net sales | Operating profit | Ordinary profit | Profit | |||||||||||||||||||||
Nine months ended | Million yen | % | Million yen | % | Million yen | % | Million yen | % | ||||||||||||||||
June 30, 2021 | 117 | 91.4 | (304) | ― | (245) | ― | (246) | ― | ||||||||||||||||
June 30, 2020 | 61 | ― | (222) | ― | (166) | ― | (167) | ― | ||||||||||||||||
Basic earnings | Diluted | |||||||||||||||||||||||
earnings | ||||||||||||||||||||||||
per share | ||||||||||||||||||||||||
per share | ||||||||||||||||||||||||
Nine months ended | Yen | Yen | ||||||||||||||||||||||
June 30, 2021 | (60.13) | ― | ||||||||||||||||||||||
June 30, 2020 | (160.57) | ― | ||||||||||||||||||||||
Note: Although potential shares existed, diluted earnings per share are not shown, as a net loss per share was | ||||||||||||||||||||||||
recorded. | ||||||||||||||||||||||||
(2) Financial Position | ||||||||||||||||||||||||
Total assets | Net assets | Equity ratio | ||||||||||||||||||||||
Million yen | Million yen | % | ||||||||||||||||||||||
As of June 30, 2021 | 2,619 | 2,557 | 97.6 | |||||||||||||||||||||
As of September 30, 2020 | 2,350 | 2,188 | 93.1 | |||||||||||||||||||||
Reference: Equity: As of | June 30, 2021: ¥2,557 | million | ||||||||||||||||||||||
As of September 30, 2020: ¥2,188 million | ||||||||||||||||||||||||
2. Dividends | ||||||||||||||||||||||||
Annual dividends | ||||||||||||||||||||||||
1st quarter-end | 2nd quarter-end | 3rd quarter-end | Year-end | Total | ||||||||||||||||||||
Fiscal year ended | Yen | Yen | Yen | Yen | Yen | |||||||||||||||||||
― | ― | ― | 0.00 | 0.00 | ||||||||||||||||||||
September 30, 2020 | ||||||||||||||||||||||||
Fiscal year ending | ― | ― | 0.00 | |||||||||||||||||||||
September 30, 2021 | ||||||||||||||||||||||||
Fiscal year ending | ||||||||||||||||||||||||
September 30, 2021 | 0.00 | 0.00 | ||||||||||||||||||||||
(Forecast) | ||||||||||||||||||||||||
Note: Revision to the | dividend forecast | announced most recently: None |
3. Financial Results Forecast for the Fiscal Year Ending September 30, 2021 (October 1, 2020 - September 30, 2021)
(% indicates changes from the previous corresponding period.)
Net sales | Operating profit | Ordinary profit | Profit | Basic earnings | |||||
per share | |||||||||
Full year | Million yen | % | Million yen | % | Million yen | % | Million yen | % | Yen |
227 | (40.7) | (388) | ― | (328) | ― | (330) | ― | (80.67) |
Note: Revision to the financial results forecast announced most recently: Yes
* Notes:
(1) Accounting methods adopted particularly for the preparation of quarterly financial statements: None
(2) Changes in accounting policies, changes in accounting estimates and retrospective restatement 1) Changes in accounting policies due to the revision of accounting standards: None
2) Changes in accounting policies other than 1) above: None
3) Changes in accounting estimates: None
4) Retrospective restatement: None
(3) Total number of issued and outstanding shares (common shares)
1) Total number of issued and outstanding shares at the end of the period (including treasury shares):
As of June 30, 2021: | 4,320,700 shares |
As of September 30, 2020: | 3,647,700 shares |
2) Total number of treasury shares at the end of the period: | |
As of June 30, 2021: | ― shares |
As of September 30, 2020: | ― shares |
3) Average number of shares during the period: | |
For the nine months ended June 30, 2021: | 4,095,854 shares |
For the nine months ended June 30, 2020: | 1,041,060 shares |
Note: We conducted a 20-for-1 share split on November 12, 2020. Total number of issued and outstanding shares, total number of treasury shares, and average number of shares are calculated as if the share split had taken place at the beginning of fiscal year ended September 30, 2020.
- These quarterly financial results are outside the scope of quarterly review by certified public accountants or an audit firm.
-
Explanation of the proper use of financial results forecast and other notes
The earnings forecasts and other forward-looking statements herein are based on information currently available to the Company and certain assumptions deemed reasonable at the time of the release of these materials. Actual results may differ significantly from these forecasts due to various factors.
Table of Contents - Attachments | ||
1. Qualitative Information on Quarterly Financial Results ......................................................................... | 2 | |
(1) | Explanation of Operating Results ....................................................................................................... | 2 |
(2) | Explanation of Financial Position ....................................................................................................... | 4 |
(3) | Explanation of Financial Results Forecast and Other Forward-looking Information ........................... | 4 |
2. Quarterly Financial Statements and Principal Notes ............................................................................... | 5 | |
(1) | Quarterly Balance Sheets .................................................................................................................... | 5 |
(2) | Quarterly Statements of Income .......................................................................................................... | 6 |
(3) | Notes to Quarterly Financial Statements ............................................................................................. | 7 |
Notes on going concern assumption ............................................................................................... | 7 | |
Notes in case of significant changes in shareholders' equity ......................................................... | 7 | |
Significant subsequent events ........................................................................................................ | 7 |
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1. Qualitative Information on Quarterly Financial Results
-
Explanation of Operating Results
The forward-looking statements herein are based on the judgments of Kringle Pharma, Inc. (the "Company") as of the end of the third quarter under review.
1. Drug development activities
(a) Acute spinal cord injury (SCI)
The Company conducted a Phase I/II clinical trial with Professor Masaya Nakamura of the Department of Orthopaedic Surgery, Keio University School of Medicine as a coordinating investigator and obtained results that confirmed the safety and indicated the efficacy of the drug. The Company designed the next Phase III clinical trial to verify the proof of concept (POC; a preliminary evidence of efficacy detected in human with a new drug candidate under development) obtained in the Phase I/II clinical trial. On June 9, 2020, the Company submitted a clinical trial notification for the Phase III study to the Pharmaceuticals and Medical Devices Agency (PMDA).
In July 2020, the Company started the Phase III study at Spinal Injuries Center, Hokkaido Spinal Cord Injury Center, and Murayama Medical Center. With the addition of Japanese Red Cross Kobe Hospital and Aijinkai Rehabilitation Hospital in March 2021, the phase III clinical trial is now ongoing at the five medical facilities where patients are being enrolled.
In order to submit marketing authorization application for the treatment of acute SCI, the Company is conducting various tests related to the process of manufacturing recombinant human HGF. Trial manufacturing (process validation) is currently underway for the drug substance, which is required for the submission, using the same process as commercial manufacturing.
For the purpose of identifying more effective administration methods and schedule with recombinant human HGF for SCI, the Company launched a new joint research program with Keio University School of Medicine in February 2021 to investigate possible combination with the transplantation technique for iPS cell- derived neural progenitor cells.
In June 2021, the APSS Congress Best Clinical Research Award was given for the presentation on Phase I/II clinical trial for acute SCI at the 13th Combined Meeting of Asia Pacific Spine Society & Asia Pacific Paediatric Orthopaedic Society (APSS-APPOS 2021; held from June 9 to 12, 2021 at Kobe International Conference Center).
(b) Amyotrophic lateral sclerosis (ALS)
The investigator-initiated Phase II clinical trial started in May 2016 at Tohoku University Hospital and Osaka University Hospital by Professor Masashi Aoki of the Department of Neurology, Tohoku University. In November 2020, the enrollment of patients completed and the administration of the investigational drug is now continuing. The Company engages in the trial by supplying the investigational drug, supporting clinical trial operations, and performing the drug stability tests which were conducted during the nine months ended June 30, 2021.
In addition, during the nine months ended June 30, 2021, the Company continued to support the clinical trial financially mainly covering the cost for contract research organization (CRO), in order to avoid a delay of the study due to the termination of subsidies provided by Japan Agency for Medical Research and Development (AMED) in March 2021.
(c) Vocal fold scarring (VFS)
For VFS, a disorder in which the vocal fold mucosa hardens and degenerates (fibrosis), an investigator- initiated Phase I/II clinical trial confirmed safety of intracordal administration of the recombinant human HGF. It also detected signals of efficacy showing functional recovery of the vocal cord with some patients (J Tissue Eng Regen Med. 2017; 1-8.). Preliminary consultation meeting with PMDA was conducted in July 2019, based on which discussion is ongoing with Kyoto Prefectural University of Medicine to design details of the next
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phase trial (double-blind,placebo-controlled comparative study) aimed at obtaining POC. The Company has also continued to try acquiring grants or subsidies to fund the trial.
(d) Supply of drug substance to Claris Biotherapeutics, Inc.
The Company concluded a license and supply agreement with Claris Biotherapeutics, Inc. of the U.S. in April 2020 to supply HGF drug substance for clinical development by Claris Biotherapeutics to treat ophthalmologic diseases in the U.S. During the nine months ended June 30, 2021, the Company's supply of HGF drug substance to Claris Biotherapeutics was continued for use in manufacturing the investigational product and conducting preclinical studies. Claris Biotherapeutics filed an investigational new drug (IND) application* in May 2021 to initiate a Phase I/II clinical trial utilizing the various preclinical and clinical information related to HGF provided by the Company.
- Clinical trial application filed with the U.S. Food and Drug Administration (FDA)
2. Business development activities
During the nine months ended June 30, 2021, the Company had business development discussion with potential business partners to expand development of acute SCI outside Japan. In an effort to promote development of VFS, the Company also investigated a possibility to fund the project through partnership and/or subsidies.
As a result of these efforts, during the nine months ended June 30, 2021, net sales amounted to ¥117,825 thousand, while the Company recorded an operating loss, ordinary loss and loss of ¥304,865 thousand, ¥245,177 thousand, and ¥246,295 thousand, respectively.
Since the Company operates in a single segment of pharmaceutical development business, segment information is omitted.
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Kringle Pharma Inc. published this content on 20 August 2021 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 20 August 2021 06:43:03 UTC.
