NB: this is a summary translation of the press release original drafted in Japanese for the disclosure required in compliance with the TSE regulations.

Non-consolidated Financial Results

for the Three Months Ended March 31, 2021

[Japanese GAAP]

May 7, 2021

Company name: Oncolys BioPharma Inc.

Stock exchange listing: Tokyo Stock Exchange

Code number: 4588

URL: http://www.oncolys.com

Representative: Yasuo Urata, President & CEO

Contact: Keiji Yoshimura, Vice President & Accounting

Email: oncolys_information@oncolys.com

Scheduled date of filing quarterly securities report: May 7, 2021

Scheduled date of commencing dividend payments: ―

Availability of supplementary briefing material on quarterly financial results: No

Schedule of quarterly financial results briefing session: No

(Amounts of less than one million yen are rounded down.)

1. Financial Results for the Three Months Ended March 31, 2021 (January 1, 2021 to March 31, 2021)

(1) Operating Results

(% indicates changes from the previous corresponding period.)

Net sales

Operating profit

Ordinary profit

Profit

Three months ended

Million yen

%

Million yen

%

Million yen

%

Million yen

%

March 31, 2021

62

(10.9)

(349)

-

(349)

-

(350)

-

March 31, 2020

70

45.2

(287)

-

(285)

-

(286)

-

Basic earnings

Diluted earnings

per share

per share

Three months ended

Yen

Yen

March 31, 2021

(22.36)

-

March 31, 2020

(19.96)

-

(2) Financial Position

Total assets

Net assets

Equity ratio

Million yen

Million yen

%

As of March 31, 2021

5,463

4,768

87.1

As of December 31, 2020

2,796

2,003

71.4

(Reference) Equity: As of March 31, 2021: ¥4,761 million As of December 31, 2020: ¥1,995 million

2. Dividends

Annual dividends

1st

2nd

3rd

Year-end

Total

quarter-end

quarter-end

quarter-end

Fiscal year ended

Yen

Yen

Yen

Yen

Yen

-

0.00

-

0.00

0.00

December 31, 2020

Fiscal year ending

-

December 31, 2021

Fiscal year ending

December 31, 2021

0.00

-

0.00

0.00

(Forecast)

(Note) Revision to the forecast for dividends announced most recently: No

3. Financial Results Forecast for the Fiscal Year Ending December 31, 2021 (January 1, 2021 to December 31, 2021)

(% indicates changes from the previous corresponding period for the full year.)

Net sales

Operating profit

Ordinary profit

Profit

Basic earnings

per share

Million yen

%

Million yen

%

Million yen

%

Million yen

%

Yen

350

111.4

(2,000)

(2,000)

(2,000)

(136.59)

Fiscal year

~

~

~

-

~

-

~

-

~

700

222.9

(1,650)

(1,650)

(1,650)

(112.69)

(Note) Revision to the financial results forecast announced most recently: No

* Notes:

  1. Accounting policies adopted specially for the preparation of quarterly financial statements: No
  2. Changes in accounting policies, accounting estimates and retrospective restatement
    1. Changes in accounting policies due to the revision of accounting standards: No
    2. Changes in accounting policies other than 1) above: No
    3. Changes in accounting estimates: No
    4. Retrospective restatement: No
  3. Total number of issued shares (common shares)
    1. Total number of issued shares at the end of the period (including treasury shares):

March 31, 2021: 17,328,600 shares

December 31, 2020: 14,641,900 shares

  1. Total number of treasury shares at the end of the period: March 31, 2021: 19,462 shares
    December 31, 2020: 14,462 shares
  2. Average number of shares during the period:

Three months ended March 31, 2021: 15,677,731 shares

Three months ended March 31, 2020: 14,330,099 shares

  • These quarterly financial results are outside the scope of quarterly review by certified public accountants or an audit corporation.
  • Explanation of the proper use of financial results forecast and other notes

(Note regarding forward-looking statements, etc.)

The earnings forecasts and other forward-looking statements herein are based on information available to the Company at the time of the release of these materials and certain assumptions deemed reasonable, and do not represent a commitment from the Company that they will be achieved. In addition, actual financial results, etc. may differ significantly due to a wide range of factors. For the assumptions used in forecasting financial results and notes regarding the use of financial forecasts, etc., please see "1. Qualitative Information on Quarterly Financial Results for the Period under Review (3) Explanation of Financial Results Forecast and Other Forward- looking Information" on page 3 of the supplementary material.

Table of Contents

1. Qualitative Information on Quarterly Financial Results for the Period under Review ..................................

2

(1)

Explanation of Business Results ................................................................................................................

2

(2)

Explanation of Financial Position ..............................................................................................................

2

(3)

Explanation of Financial Results Forecast and Other Forward-looking Information ................................

3

2. Quarterly Financial Statements and Primary Notes..........................................................................................

4

(1)

Quarterly Balance Sheets ...........................................................................................................................

4

(2)

Quarterly Statements of Income .................................................................................................................

6

Three Months Ended March 31....................................................................................................................

6

(3)

Notes to Quarterly Financial Statements......................................................................................................

7

(Notes on going concern assumption) ........................................................................................................

7

(Notes in the case of significant changes in shareholders' equity) ............................................................

7

(Segment information, etc.) ........................................................................................................................

7

3. Supplemental Information ................................................................................................................................

8

(1)

Research and development activities .........................................................................................................

8

1

1. Qualitative Information on Quarterly Financial Results for the Period under Review

(1) Explanation of Business Results

The Japanese economy during the three months ended March 31, 2021 saw the government declare a state of emergency again due to the spread of COVID-19, which has left a significant impact on economic activities. While the Nikkei Stock Average exceeded the ¥30 thousand mark for the first time in approximately 30 years, the outlook is expected to remain uncertain.

Amid these circumstances, Oncolys BioPharma Inc. (hereinafter "the Company") endeavored to increase management efficiency and actively expanded its research, development, and licensing activities in the drug discovery business. For details of the Company's activities, please refer to "3. Supplemental Information (1) Research and development activities."

The Company was previously composed of two reportable segments classified as the "pharmaceutical business" and the "diagnostic business." However, since more than 99% of net sales of the Company are from the pharmaceutical business and the trend is expected to continue, the company changed the method of performance management and changed to a single segment of the "drug discovery business" from the first quarter of the fiscal year under review. Information by segment is therefore omitted.

In the drug discovery business during the three months ended March 31, 2021, Chugai Pharmaceutical Co., Ltd. (hereinafter "Chugai"), the licensee, began administration of Telomelysin virotherapy for cancer to the first patient in the clinical trial for hepatocellular cancer, following the trial for esophageal cancer. Furthermore, Chugai has started recruiting patients for the clinical trial in combination with chemoradiotherapy for esophageal cancer. With regards to clinical trials in the U.S. led by the Company, patient recruitment has started for the clinical trial in combination with chemoradiotherapy for esophageal cancer and the clinical trial for head and neck cancer, and administration to the first patient is expected to take place in the first half of 2021. For OBP-2011 for the treatment of COVID-19, the Company decided to commission GMP manufacturing of active pharmaceutical ingredients for investigational drugs to Iwaki Seiyaku and promoted activities with a view to applying in 2022 to conduct clinical trials. The Company also promoted clinical research with Juntendo University for TelomeScan, a cancer detection drug.

As a result, for the three months ended March 31, 2021, net sales were ¥62,603 thousand (net sales of ¥70,274 thousand in the same period of the previous year), and operating loss was ¥349,453 thousand (operating loss of ¥287,690 thousand in the same period of the previous year). In addition, the Company recorded interest income of ¥131 thousand, foreign exchange gains of ¥25,702 thousand, and other items as non-operating income and interest expenses of ¥932 thousand, amortization of restricted stock remuneration of ¥14,220 thousand, share issuance costs of ¥10,905 thousand, and other items as non-operating expenses. As a result, ordinary loss was ¥349,626 thousand (ordinary loss of ¥285,059 thousand in the same period of the previous year), and loss was ¥350,567 thousand (loss of ¥286,022 thousand in the same period of the previous year).

(2) Explanation of Financial Position

Status of Assets, Liabilities and Net Assets

Assets at the end of the first quarter of the fiscal year under review were ¥5,463,183 thousand (95.4% increase compared with the end of the previous fiscal year), owing partly to an increase in cash and deposits. Specifically, the increase was mainly due to financing through issuance and exercise of share acquisition rights to develop a commercially viable manufacturing method for Telomelysin and for research and development expenses for next generation Telomelysin OBP-702 and OBP-2011, as well as through taking out long-term loans from Kobe Shinkin Bank. Liabilities were ¥694,343 thousand (12.5% decrease compared with the end of the previous fiscal year), owing partly to repayment of accounts payable - other. Net assets were ¥4,768,839

2

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Oncolys BioPharma Inc. published this content on 07 May 2021 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 07 May 2021 09:04:06 UTC.