BEYONDSPRING INC.

BYSI
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BeyondSpring : 2020 First Quarter Financial Report

06/25/2020 | 02:49pm

EX-99.1 2 ex99_1.htm EXHIBIT 99.1

Exhibit 99.1

BeyondSpring Reports First-Quarter 2020 Financial Results and Operational Update

- PROTECTIVE-2 (Study 106) Phase 3 Interim Analysis This Month to Evaluate Superiority in CIN -

- PROTECTIVE-2 Phase 2 Shows Positive Results in Chemotherapy Optimization with Potentially Better Clinical Outcomes -

- DUBLIN-3 (Study 103 Phase 3) Second Interim Analysis for NSCLC Received DSMB's Recommendation to Continue Without

Modification -

NEW YORK, June 11, 2020 - BeyondSpring Inc. (the "Company" or "BeyondSpring") (NASDAQ: BYSI), a global biopharmaceutical company focused on the development of innovative cancer therapies, announced today its financial results and provided an operational update for the three months ended March 31, 2020.

"During the first quarter, we continued to make progress in the two lead indications for Plinabulin for both the prevention of chemotherapy-induced neutropenia (CIN) and treatment of non-small cell lung cancer (NSCLC)," said Dr. Lan Huang, Co-Founder, Chairman and Chief Executive Officer. "Our recent data from PROTECTIVE-2 Phase 2 showed Plinabulin combined with G-CSF improves chemotherapy compliance compared to G-CSF alone, which potentially leads to better clinical outcomes. The Plinabulin-G-CSF combination's potential to prevent infection and hospitalization becomes even more important to the physicians, patients and the healthcare system in the COVID-19 pandemic. We expect to reach the pre-specified interim analysis for PROTECTIVE-2 Phase 3 this month to evaluate superiority in CIN, which has the potential to mark the first significant enhancement in preventing neutropenia in 30 years."

"With over 1,200 patients enrolled to date for Plinabulin clinical programs, we believe we are well-positioned to capitalize on our upcoming regulatory milestones with multiple New Drug Application (NDA) filings followed by near term commercial opportunities. Looking ahead, we continue to advance our clinical studies to support our view of Plinabulin as a 'pipeline in a drug' and believe its potential in improving standard of care in CIN prevention and cancer treatments will help many patients in need globally."

Select First-Quarter 2020 and Recent Operational Highlights

Chemotherapy-Induced Neutropenia (CIN)

PROTECTIVE-2 Phase 2 for Chemotherapy-Induced Neutropenia Shows Positive Results in Chemotherapy Optimization with Potentially Better Clinical Outcomes

In June 2020, BeyondSpring announced that PROTECTIVE-2 Phase 2 superiority trial for CIN shows that Plinabulin in combination with Neulasta (pegfilgrastim), a long-lasting G-CSF, which is a predominant therapy to treat CIN, enables more cancer patients to receive the optimal chemotherapy dose and regimen, which potentially leads to better clinical outcomes.

  • • In breast cancer patients treated with docetaxel, doxorubicin and cyclophosphamide (TAC, a high-risk chemotherapy) with 20mg/m2 of Plinabulin combined with 6mg of Neulasta (n=16) compared with 6mg of Neulasta alone (n=22), Plinabulin + G-CSF improved compliance with targeted chemotherapy

  • • Dose reduction (over 15 percent): only 6.3 percent of patients in the Plinabulin-Neulasta combination arm versus 22.7 percent in Neulasta arm - a 72 percent improvement

  • • Downgraded regimen (from TAC, to docetaxel and cyclophosphamide, or TC): No (0 percent) patients in the Plinabulin + G-CSF arm downgraded chemotherapy from the TAC regimen to the TC regimen versus 18.2 percent in the Neulasta arm - p < 0.05

Plinabulin's Mechanism of Action Complements Neulasta in Cancer Treatment

In May 2020, two Company abstracts were presented at this year's American Society of Clinical Oncology (ASCO) Virtual Scientific Program, evaluating Plinabulin alongside Neulasta.

  • • BeyondSpring's e-publication, titled, "Comparison of CD34+ mobilization effects of standard dose pegfilgrastim (Peg) versus low-dose peg combined with plinabulin (Plin)," demonstrates the efficacy of Plinabulin-Neulasta combination in increasing CD34+ counts for patients, with fewer adverse events

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  • • Additionally, BeyondSpring's poster presentation, titled, "Head-to-head comparison of the non-G-CSF small molecule single agent (SA) plinabulin with SA pegfilgrastim for the prevention of docetaxel chemotherapy (chemo)-induced neutropenia (CIN) in the protective-1 trial," compares Plinabulin versus Neulasta as an effective monotherapy for CIN prevention

Non-Small Cell Lung Cancer (NSCLC)

DSMB Recommends DUBLIN-3 Phase 3 NSCLC to Continue Without Modification

In June 2020, BeyondSpring reported it had reached the pre-specified second interim analysis for DUBLIN-3 for NSCLC treatment with Plinabulin.

  • • Upon reviewing the efficacy and safety data of over 500 patients at an approximately 300-patient death event, DSMB advised BeyondSpring to continue the study without any modifications

  • • DUBLIN-3 is a global Phase 3 trial for Plinabulin, in combination with docetaxel versus docetaxel alone, for the treatment of second- / third-line EGFR wild-type NSCLC

  • • Thus far, over 600 cancer patients have been dosed with Plinabulin, which has demonstrated good tolerability and satisfies the safety database standard of both the U.S. Food and Drug Administration (FDA) and China's National Medical Products Administration (NMPA)

Intellectual Properties

BeyondSpring Granted U.S. Patent for Plinabulin to Treat Severe CIN from Taxane in Cancer Patients

  • • In May 2020, the U.S. Patent and Trademark Office (USPTO) granted BeyondSpring a new patent for methods of treating severe CIN in cancer patients treated with taxane with protection through 2033. This patent establishes Plinabulin's beneficial effects in reducing CIN associated with taxane, one of the most commonly used chemotherapies

  • • The Company currently owns 76 patents, including 17 issued U.S. patents, for Plinabulin and its analogs with protection through 2036

Financial Results for the Three Months Ended March 31, 2020

Research and development ("R&D") expenses were $13.7 million for the quarter ended March 31, 2020, compared to $6.3 million for the quarter ended March 31, 2019. The $7.4 million increase was largely attributable to an increase of $4.4 million in clinical trial expenses and an increase of $3.0 million in non-cash share-based compensation.

Selling, general and administrative ("SG&A") expenses were $2.9 million for the quarter ended March 31, 2020, compared to $1.6 million for the quarter ended March 31, 2019. The $1.3 million increase was mainly due to a $0.6 million increase in commercial and marketing expense, a $0.3 million increase in salary, wages and benefits expense, and a $0.4 million increase in other expenses.

Net loss attributable to the Company was $16.1 million for the quarter ended March 31, 2020, compared to $7.3 million for the quarter ended March 31, 2019.

As of March 31, 2020, the Company had a cash balance of $24.9 million. The Company believes currently available financial resources will be sufficient to support its clinical trials and submit NDAs in the U.S. and China for Plinabulin for the CIN and NSCLC indications, as well as to advance its immuno-oncology pipeline and ubiquitination protein degradation research platform.

Anticipated Milestones

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

  • • Interim topline data readout for PROTECTIVE-2 Phase 3 for CIN - June 2020

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  • • Final data readout for PROTECTIVE-2 Phase 3 for CIN - H2 2020

  • • Final data readout for PROTECTIVE-1 Phase 3 for CIN - H2 2020

  • • NDA submission for Plinabulin for CIN in the U.S. - H2 2020

  • • Final data readout for DUBLIN-3 for NSCLC - H2 2020

  • • NDA submission for Plinabulin for NSCLC in China - H2 2020

  • • NDA submission for Plinabulin for NSCLC in the U.S. - H1 2021

About BeyondSpring

BeyondSpring is a global clinical-stage biopharmaceutical company focused on the development of innovative immuno-oncology cancer therapies. BeyondSpring's lead asset, first-in-class agent Plinabulin, is in a Phase 3 global clinical trial as a direct anticancer agent in the treatment of non-small cell lung cancer (NSCLC) and two Phase 3 clinical programs in the prevention of chemotherapy-induced neutropenia (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 ubiquitination degradation pathway. 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, the impact of widespread health developments, including the recent COVID-19 pandemic, and the responses thereto, which could materially and adversely affect, among other things, enrollment of patients in our clinical trials and our expected timeline for data readouts of our clinical trials and certain regulatory filings for our product candidates, unexpected changes to estimates of our expenses, future revenues and capital requirements, 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.

Contacts

Scott Eckstein / Caitlin Kasunich KCSA Strategic Communications 212.896.1210 / 212.896.1241 seckstein@kcsa.com / ckasunich@kcsa.com

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BEYONDSPRING INC.

AUDITED CONSOLIDATED BALANCE SHEET AS OF DECEMBER 31, 2019 AND

UNAUDITED INTERIM CONDENSED CONSOLIDATED BALANCE SHEET AS OF MARCH 31, 2020

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

Assets

Current assets:

December 31, March 31,Note

2019 2020 $ $

(Unaudited)

Cash and cash equivalents

35,933

24,917

Advances to suppliers

4,519

4,384

Prepaid expenses and other current assets

410

452

Total current assets

40,862

29,753

Noncurrent assets:

Property and equipment, net

3

209

203

Operating lease right-of-use assets

2,538

2,607

Other noncurrent assets

946

941

Total noncurrent assets

3,693

3,751

Total assets

44,555

33,504

Liabilities and equity

Current liabilities:

Accounts payable

2,537

5,140

Accrued expenses

5,861

4,697

Due to related parties

5

29

42

Current portion of operating lease liabilities

537

643

Other current liabilities

11

1,089

1,685

Total current liabilities

10,053

12,207

Noncurrent liabilities:

Long-term loans

4

1,436

1,413

Operating lease liabilities

1,935

1,892

Total noncurrent liabilities

3,371

3,305

Total liabilities

13,424

15,512

Equity:

Ordinary shares ($0.0001 par value; 500,000,000 shares authorized; 27,885,613 shares

and 27,888,906 shares issued and outstanding as of December 31, 2019 and March

31, 2020, respectively)

7

3

3

Additional paid-in capital

7

246,979

250,417

Accumulated deficit

7

(216,845)

(232,929)

Accumulated other comprehensive income

7

140

197

Total BeyondSpring Inc.'s shareholder's equity

30,277

17,688

Noncontrolling interests

7

854

304

Total equity

31,131

17,992

Total liabilities and equity

44,555

33,504

The accompanying notes are an integral part of these unaudited interim condensed consolidated financial statements.

Disclaimer

BeyondSpring Inc. published this content on 11 June 2020 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 25 June 2020 18:48:02 UTC

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