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November 17, 2020

BeyondSpring Announces Third Quarter 2020 Financial Results and Provides Business Updates

Announced SEED Therapeutics Inc.(“SEED”)’s collaboration with Eli Lilly and Company(“Lilly”)

NEW YORK, Nov. 17, 2020 (GLOBE NEWSWIRE) -- BeyondSpring Inc. (the “Company” or “BeyondSpring”) (NASDAQ: BYSI), a global biopharmaceutical company focused on the development of innovative cancer therapies, today announced its financial results and provided an operational update for the three months ended September 30, 2020.

We were thrilled to announce positive top-line data in our pivotal Phase 3 study demonstrating plinabulin in combination with pegfilgrastim (peg) provides superior benefits for patients in preventing chemotherapy-induced neutropenia (CIN) compared with peg alone. Results show combination plinabulin + peg’s ability to reduce infection and hospitalization rates after chemotherapy, allowing for the potential for patients to continue receiving life-saving treatments. This means patients may potentially receive more stable doses, longer sustained cycles and the strongest regimens possible resulting in potential survival benefit,” said Dr. Lan Huang, co-founder, chairperson and chief executive officer of BeyondSpring. “We expect to file a New Drug Application (NDA) for CIN, plinabulin’s first indication, in the U.S. in early 2021, soon followed by an NDA submission in China and look forward bringing this important therapy to market.

Select Third Quarter 2020 and Recent Business Highlights

Recent Clinical Highlights

Breakthrough Therapy Designation

Received Breakthrough Therapy Designation for plinabulin in CIN from both the U.S. FDA and China’s Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA). FDA’s Breakthrough Therapy designation is intended to expedite the development and review of a drug candidate that is planned to treat a serious or life- threatening disease or condition in which clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints.

Recent Corporate Highlights

SEED’s collaboration with Lilly

Announced a research collaboration and license agreement and a share purchase agreement between SEED and Lilly in the area of targeted protein degradation (TPG), or “molecular glue”, SEED will receive a $10 million upfront payment, up to $10 million investment and up to approximately $780 million in milestones related to preclinical, clinical, regulatory and commercial milestones, plus royalties on net sales of products that result from the collaboration.

BeyondSpring Appoints Elizabeth Czerepak as Chief Financial Officer

Announced the appointment of Elizabeth Czerepak to the role of chief financial officer. Ms. Czerepak brings to BeyondSpring more than 30 years of senior finance and leadership experience, including Board and venture capital experience. Ms. Czerepak most recently served as CFO and chief business officer of Genevant Sciences. Simultaneously, the Company announced the appointment of Edward Liu as chief financial officer to SEED focused on a targeted protein degradation platform to attack previously believed undruggable targets.

Financial Results for the Three Months Ended September 30, 2020

Research and development (“R&D”) expenses were $8.6 million for the quarter ended September 30, 2020, compared to $7.2 million for the quarter ended September 30, 2019. The $1.4 million increase was largely attributable to higher clinical trial costs and NDA preparation costs.

General and administrative (“G&A”) expenses were $6.7 million for the quarter ended September 30, 2020, compared to $2.5 million for the quarter ended September 30, 2019. The $4.2 million increase was primarily due to an increase of $2.0 million related to pre-launch commercialization costs for plinabulin, and an increase of $1.9 million in G&A employees’ compensation.

Net loss attributable to the Company was $14.5 million for the quarter ended September 30, 2020, compared to $9.4 million for the quarter ended September 30, 2019.

As of September 30, 2020, the Company had cash and cash equivalents of $30.9 million on hand. The Company believes with the implementation of a cost reduction plan it has sufficient cash to support its clinical trials and the preparation of NDA submissions in the U.S. and China for plinabulin for the CIN and NSCLC indications, as well as to advance its immuno- oncology pipeline and protein degradation research platform.

Anticipated Milestones

The following outlines the Company’s anticipated upcoming milestones and projected timelines:

  • NDA submission for plinabulin for CIN in the U.S. – Early 2021
  • NSCLC phase 3 data readout – H1 2021
  • Rolling NDA submission for plinabulin for NSCLC in China – H1 2021

About BeyondSpring
BeyondSpring is a global, clinical-stage biopharmaceutical company focused on the development of innovative cancer therapies. BeyondSpring’s lead asset, plinabulin, a first-in-class agent as an immune and stem cell modulator, is in a Phase 3 global clinical trial as a direct anticancer agent in the treatment of non-small cell lung cancer (NSCLC) and Phase 3 clinical programs in the prevention of CIN. BeyondSpring has strong R&D capabilities with a robust pipeline in addition to plinabulin, including three immuno-oncology assets and a drug discovery platform using the protein degradation pathway, which is being developed in a subsidiary company, Seed Therapeutics, Inc. The Company also has a seasoned management team with many years of experience bringing drugs to the global market. BeyondSpring is headquartered in New York City.

Cautionary Note Regarding Forward-Looking Statements
This press release includes forward-looking statements that are not historical facts. Words such as "will," "expect," "anticipate," "plan," "believe," "design," "may," "future," "estimate," "predict," "objective," "goal," or variations thereof and variations of such words and similar expressions are intended to identify such forward-looking statements. Forward-looking statements are based on BeyondSpring's current knowledge and its present beliefs and expectations regarding possible future events and are subject to risks, uncertainties and assumptions. Actual results and the timing of events could differ materially from those anticipated in these forward-looking statements as a result of several factors including, but not limited to, difficulties raising the anticipated amount needed to finance the Company's future operations on terms acceptable to the Company, if at all, unexpected results of clinical trials, delays or denial in regulatory approval process, results that do not meet our expectations regarding the potential safety, the ultimate efficacy or clinical utility of our product candidates, increased competition in the market, and other risks described in BeyondSpring’s most recent Form 20-F on file with the U.S. Securities and Exchange Commission. All forward-looking statements made herein speak only as of the date of this release and BeyondSpring undertakes no obligation to update publicly such forward-looking statements to reflect subsequent events or circumstances, except as otherwise required by law.

BEYONDSPRING INC.

AUDITED CONSOLIDATED BALANCE SHEET AS OF DECEMBER 31, 2019 AND

UNAUDITED INTERIM CONDENSED CONSOLIDATED BALANCE SHEET AS OF SEPTEMBER 30, 2020

(Amounts in thousands of U.S. Dollars (“$”), except for number of shares and per share data)

 

 

 

 

 

 

 

 

 

December 31,

 

 

September 30,

 

 

 

 

2019

 

 

2020

 

 

 

 

$

 

 

$

 

 

 

 

 

 

(Unaudited)

 

Assets

 

 

 

 

 

 

 

 

 

 

 

Current assets:

 

 

 

 

 

Cash and cash equivalents

 

35,933

 

 

30,874

 

 

Advances to suppliers

 

4,519

 

 

4,328

 

 

Prepaid expenses and other current assets

 

410

 

 

485

 

 

Total current assets

 

40,862

 

 

35,687

 

 

 

 

 

 

 

 

Noncurrent assets:

 

 

 

 

 

Property and equipment, net

 

209

 

 

189

 

 

Operating lease right-of-use assets

 

2,538

 

 

2,340

 

 

Other noncurrent assets

 

946

 

 

1,180

 

 

Total noncurrent assets

 

3,693

 

 

3,709

 

 

 

 

 

 

 

 

Total assets

 

44,555

 

 

39,396

 

 

 

 

 

 

 

 

 

 

Liabilities and equity

 

 

 

 

 

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

Accounts payable

 

2,537

 

 

2,191

 

 

Accrued expenses

 

5,861

 

 

8,380

 

 

Due to related parties

 

29

 

 

-

 

 

Current portion of operating lease liabilities

 

537

 

 

697

 

 

Other current liabilities

 

1,089

 

 

1,551

 

 

Total current liabilities

 

10,053

 

 

12,819

 

 

 

 

 

 

 

 

 

 

Noncurrent liabilities:

 

 

 

 

 

Long-term loans

 

1,436

 

 

2,108

 

 

Operating lease liabilities

 

1,935

 

 

1,546

 

 

Total noncurrent liabilities

 

3,371

 

 

3,654

 

 

 

 

 

 

 

 

 

 

Total liabilities

 

13,424

 

 

16,473

 

 

 

 

 

 

 

 

 

 

Equity:

 

 

 

 

 

Ordinary shares ($0.0001 par value; 500,000,000

 

 

 

 

 

shares authorized; 27,885,613 and 30,516,401 shares

 

 

 

 

 

issued and outstanding as of December 31,

 

 

 

 

 

2019 and September 30, 2020, respectively)

 

3

 

 

3

 

 

Additional paid-in capital

 

246,979

 

 

284,310

 

 

Accumulated deficit

 

(216,845

)

 

(260,222

)

 

Accumulated other comprehensive income (loss)

 

140

 

 

(47

)

 

Total BeyondSpring Inc.’s shareholders’ equity

 

30,277

 

 

24,044

 

 

Noncontrolling interests

 

854

 

 

(1,121

)

 

Total equity

 

31,131

 

 

22,923

 

 

 

 

 

 

 

 

Total liabilities and equity

 

44,555

 

 

39,396

 

 

 

 

 

 

 

 

 



BEYONDSPRING INC.

UNAUDITED INTERIM CONDENSED CONSOLIDATED STATEMENTS OF

COMPREHENSIVE LOSS FOR THE THREE AND NINE MONTHS ENDED SEPTEMBER 30, 2019 AND 2020

(Amounts in thousands of U.S. Dollars (“$”), except for number of shares and per share data)

(Unaudited)

 

 

 

Three months ended

 

Nine months ended

 

 

 

September 30,

 

September 30,

 

 

 

2019

 

 

2020

 

 

2019

 

 

2020

 

 

 

 

$

 

 

$

 

 

$

 

 

$

 

 

 

 

 

 

 

 

 

 

 

 

Revenue

 

-

 

 

-

 

 

-

 

 

-

 

 

 

 

 

 

 

 

 

 

 

 

Operating expenses

 

 

 

 

 

 

 

 

 

Research and development

 

(7,230

)

 

(8,637

)

 

(18,762

)

 

(33,369

)

 

General and administrative

 

(2,474

)

 

(6,710

)

 

(6,260

)

 

(12,227

)

 

 

 

 

 

 

 

 

 

 

 

Loss from operations

 

(9,704

)

 

(15,347

)

 

(25,022

)

 

(45,596

)

 

Foreign exchange (loss) gain, net

 

(131

)

 

174

 

 

(127

)

 

109

 

 

Interest expense

 

(46

)

 

(21

)

 

(186

)

 

(63

)

 

Interest income

 

57

 

 

10

 

 

64

 

 

102

 

 

Other income

 

-

 

 

-

 

 

-

 

 

3

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Loss before income tax

 

(9,824

)

 

(15,184

)

 

(25,271

)

 

(45,445

)

 

Income tax benefit

 

-

 

 

-

 

 

-

 

 

-

 

 

 

 

 

 

 

 

 

 

 

 

Net loss

 

(9,824

)

 

(15,184

)

 

(25,271

)

 

(45,445

)

 

Less: Net loss attributable to

 

 

 

 

 

 

 

 

 

noncontrolling interests

 

(457

)

 

(644

)

 

(1,259

)

 

(2,068

)

 

Net loss attributable to

 

 

 

 

 

 

 

 

 

BeyondSpring Inc.

 

(9,367

)

 

(14,540

)

 

(24,012

)

 

(43,377

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net loss per share

 

 

 

 

 

 

 

 

 

Basic and diluted

 

(0.37

)

 

(0.48

)

 

(1.01

)

 

(1.51

)

 

Weighted-average shares outstanding

 

 

 

 

 

 

 

 

 

 

 

 

 

Basic and diluted

 

25,309,776

 

 

30,303,093

 

 

23,819,453

 

 

28,658,215

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Other comprehensive loss, net of tax of nil:

 

 

 

 

 

 

 

 

 

 

Foreign currency translation

 

 

 

 

 

 

 

 

 

adjustment gain (loss)

 

113

 

 

(277

)

 

144

 

 

(226

)

 

Comprehensive loss

 

(9,711

)

 

(15,461

)

 

(25,127

)

 

(45,671

)

 

Less: Comprehensive loss attributable to

 

 

 

 

 

 

 

 

 

noncontrolling interests

 

(494

)

 

(677

)

 

(1,298

)

 

(2,107

)

 

Comprehensive loss attributable to

 

 

 

 

 

 

 

 

 

BeyondSpring Inc.

 

(9,217

)

 

(14,784

)

 

(23,829

)

 

(43,564

)

© 2020 BeyondSpring Inc. All rights reserved.