BeyondSpring Announces Second Quarter 2021 Financial Results and Provides a Corporate Update

Rhea-AI Summary

BeyondSpring reported its Q2 2021 financial results, showing strong advancements in its cancer therapy, plinabulin, particularly in treating non-small cell lung cancer (NSCLC). Key data from the DUBLIN-3 study highlighted significant overall survival improvements when plinabulin was combined with docetaxel versus docetaxel alone. The company has partnered with Hengrui for plinabulin's commercial launch in Greater China. However, net loss has increased to $19.3 million, with cash reserves at $76.3 million, indicating a need for ongoing funding as developmental costs rise.

Positive

• Achieved significant survival benefits in Q2 2021 DUBLIN-3 trial for plinabulin in NSCLC.
• Secured exclusive commercialization partnership with Hengrui in Greater China.
• Total cash, cash equivalents, and short-term investments of $76.3 million as of June 30, 2021.

Negative

• Net loss increased to $19.3 million for Q2 2021, up from $12.8 million in Q2 2020.
• General and administrative expenses rose to $9.0 million, significantly impacting overall financial position.

- Management to host a call today at 8:00 am ET

NEW YORK, Sept. 10, 2021 (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 for the second quarter ended June 30, 2021 and provided an update on recent corporate events.

“We had a very productive first half of 2021. Importantly, we were thrilled to announce positive data from our registrational trial of plinabulin in 2^nd/3^rd line NSCLC, which showed significant improvement in overall survival, especially the doubling of 2-year and 3-year survival in the plinabulin and docetaxel arm vs. docetaxel alone. This underscores plinabulin’s immune durable anti-cancer benefit, which could be the gateway for its development in multiple cancer indication in triple IO combos. With the significant survival benefit and significant reduction in severe neutropenia of chemotherapy, we expect that plinabulin’s optimum profile for patient’s need is just beginning to be revealed. These data set the stage for multiple near-term catalysts over the next 6-12 months,” said Dr. Lan Huang, co-founder, chairwoman and chief executive officer of BeyondSpring.

“Our commercial teams are very busy preparing for the potential near-term commercial launch of plinabulin in our first indication in the U.S. At the same time, we have strategically positioned plinabulin for commercial success in Greater China by partnering with Hengrui, the leading oncology R&D and commercial company in China with great synergy in its pipeline with plinabulin. We believe we are truly on the cusp of unlocking the tremendous potential of plinabulin to help many patients in need,” Dr. Huang continued.

Recent Clinical and Corporate Highlights

• DUBLIN-3 Study (2^nd/3^rd line NSCLC - EGFR wild type, a global, single-blinded randomized active controlled registrational study, Plinabulin + Docetaxel vs. Docetaxel alone, primary endpoint: Overall Survival):
  Announced positive topline results of plinabulin in combination with docetaxel for the treatment of 2^nd/3^rd line non-small cell lung cancer (NSCLC) with EGFR wild type.
  • The data showed that, compared to docetaxel alone, the combination met the primary endpoint of increasing overall survival (mean OS, p=0.03; OS log-rank, p<0.04).
  • It also met key secondary endpoints, including significantly improving ORR, PFS, and 24- and 36-month OS (double OS rate vs. docetaxel) rates, and significant reduction in the incidence of Grade 4 neutropenia.
  • OS rate for 48 months is at 10.6% for plinabulin + docetaxel vs. 0% for docetaxel alone.

• Greater China Partnership on Plinabulin with Hengrui, leading R&D and commercialization company in oncology products in China:
  Announced an exclusive commercialization and co-development agreement between Jiangsu Hengrui Pharmaceuticals Co., Ltd. (or “Hengrui”) and Wanchunbulin, BeyondSpring’s China subsidiary, for plinabulin in Greater China, the key terms of which are outlined below:
  • The NDA filing for plinabulin in China has been accepted with Priority Review for prevention of CIN.
  • Hengrui receives exclusive commercialization and co-development rights to plinabulin in all indications in Greater China.
  • BeyondSpring retains global rights outside of Greater China.
  • Wanchunbulin retains manufacturing rights and is entitled to receive the full amount of sales proceeds, and will pay Hengrui a pre-determined percentage of the net sales of plinabulin in Greater China.
  • Wanchunbulin to receive up to 1.3B RMB (est. US$200M), including an upfront payment of 200M RMB (est. US$30M) and regulatory and sales milestones of up to 1.1B RMB (est. US$170M).
  • Hengrui to pay all commercialization costs, and will pay 50% of clinical development costs for future indications after CIN and NSCLC.
  • Hengrui will make an equity investment of 100M RMB (est. US$15M) into Wanchunbulin at a pre-money valuation of 3.6B RMB (est. US$560M).

• Plinabulin Triple IO combo in severe cancer indications (Phase 1 and phase 2 IIT Studies):
  
  • SCLC phase 1 data (plinabulin + Nivolumab + Ipilimumab) presented at ASCO (patients from US sites): 46% ORR for all 2^nd/3^rd line patients, and 43% for PD-L1 inhibitor failed patients (with long duration of treatment as long as 18 months).
  • Patients with 7 solid tumor types that failed PD-1/PD-L1 inhibitor at MD Anderson: first patient enrolled in June 2021. These 7 cancers include bladder cancer, melanoma, Merkel cell cancer, MSI-H Cancers (of any histology), NSCLC, renal cell cancer, and SCLC.
• Added Board Member to strengthen commercial readiness for plinabulin
  Strengthened its Board of Directors with the addition of Mr. Brendan Delaney, bringing significant expertise in commercial oncology drug launches.
  • Mr. Delaney currently serves as the Chief Commercial Officer of Constellation Pharma. Prior to this, he was the Chief Commercial Officer of Immunomedics, where he led the buildout of the marketing, sales, market access, and commercial operations teams.

Upcoming Milestones

• September 20, 2021: ESMO Late-breaking oral presentation on DUBLIN-3
  
  
• November 30, 2021: PDUFA date for plinabulin in CIN prevention
  
  
• 1H 2022: NDA Submission for plinabulin in NSCLC
  
  
• 2022: (Big Ten Cancer Research Consortium, Investigator Initiated study): Phase 2 Data expected in plinabulin + nivolumab + ipilimumab in checkpoint inhibitor-resistant SCLC.
  
  
• 2022: (MD Anderson investigator led study): Phase 1 Data expected in plinabulin + PD-1/PD-L1 inhibitors + radiation in patients with seven cancer types that failed PD-1/PD-L1.

Second Quarter Financial Results

• Research and development (“R&D”) expenses were $11.3 million for the quarter ended June 30, 2021, compared to $11.0 million for the quarter ended June 30, 2020. The increase was primarily due to higher personnel and non-cash stock-based compensation expenses, which were partially offset by lower clinical development expenses.  
• General and administrative (“G&A”) expenses were $9.0 million for the quarter ended June 30, 2021, compared to $2.6 million for the quarter ended June 30, 2020. The $6.4 million increase was primarily due to higher personnel costs, non-cash stock-based compensation expense, and costs associated with plinabulin pre-commercialization activities. 
• Net loss attributable to the Company was $19.3 million for the quarter ended June 30, 2021, compared to $12.8 million for the quarter ended June 30, 2020.
• As of June 30, 2021, the Company had cash, cash equivalents, and short-term investments of $76.3 million. The Company believes it has sufficient cash to support its ongoing clinical programs over the next year, including its immuno-oncology pipeline, and to prepare for a potential launch of plinabulin in CIN in early 2022.

Year-to-Date Financial Results

• R&D expenses were $22.6 million for the six-month period ended June 30, 2021, compared to $24.7 million for the six-month period ended June 30, 2020. The $2.1 million decrease was primarily due to lower clinical development, regulatory and non-cash stock-based compensation expenses that were partially offset by higher personnel costs. 
• G&A expenses were $15.4 million for the six-month period ended June 30, 2021, compared to $5.5 million for the six-month period ended June 30, 2020. The $9.9 million increase was primarily due to higher personnel costs, non-cash stock-based compensation expense, as well as costs associated with plinabulin pre-commercialization activities. 
• Net loss attributable to the Company was $36.3 million for the six-month period ended June 30, 2021, compared to $28.8 million for the six-month period ended June 30, 2020.

Second Quarter 2021 Results Conference Call and Webcast Details
The management of BeyondSpring will host a conference call and webcast for the investment community today, September 10, 2021, at 8:00 am ET. The conference call can be accessed by dialing 877-451-6152 (U.S. and Canada) or +1-201-389-0879 (International). The passcode for the conference call is 13722968 To access the live webcast or subsequent archived recording, click here or visit the “investors” section of the BeyondSpring website at www.beyondspringpharma.com. The webcast will be recorded and available for replay on the company’s website for 90 days.

About BeyondSpring
Headquartered in New York City, BeyondSpring is a global biopharmaceutical company focused on developing innovative cancer therapies to improve clinical outcomes for patients who have high unmet medical needs. BeyondSpring’s first-in-class lead asset plinabulin, is being developed as a “pipeline in a drug” in various cancer indications as direct anti-cancer agent and to prevent chemotherapy induced neutropenia (CIN). Plinabulin and G-CSF combination has filed for approval and has received breakthrough designation and Priority Review in the U.S. and China for the prevention of CIN with a PDUFA date of November 30, 2021, in the U.S.  In DUBLIN-3 study, a global, randomized, active controlled Phase 3 study, plinabulin and docetaxel combination has met the primary endpoint of extending overall survival compared to docetaxel alone, in 2^nd/3^rd line NSCLC (EGFR wild type). Additionally, it is being broadly studied in combination with various immuno-oncology regimens that could boost the efficacy of PD-1/PD-L1 antibodies in seven different cancers. In addition to plinabulin, BeyondSpring’s extensive pipeline includes three pre-clinical immuno-oncology assets and a subsidiary, SEED Therapeutics, which is leveraging a proprietary targeted protein degradation drug discovery platform.

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.

Investor Contact:
Ashley R. Robinson
LifeSci Advisors, LLC
+1 617-430-7577
arr@lifesciadvisors.com

Media Contact:
Darren Opland, Ph.D.
LifeSci Communications
+1 646-627-8387
darren@lifescicomms.com

BEYONDSPRING INC.
AUDITED CONSOLIDATED BALANCE SHEET AS OF DECEMBER 31, 2020 AND
UNAUDITED INTERIM CONDENSED CONSOLIDATED BALANCE SHEET AS OF JUNE 30, 2021
(Amounts in thousands of U.S. Dollars (“$”), except for number of shares and per share data)
	December 31,	June 30,
	2020	2021
	$	$
Assets
Current assets:
Cash and cash equivalents	109,537	51,306
Short-term investments	-	25,000
Advances to suppliers	3,505	2,255
Prepaid expenses and other current assets	358	1,281
Total current assets	113,400	79,842
Noncurrent assets:
Property and equipment, net	184	169
Operating lease right-of-use assets	2,174	1,127
Other noncurrent assets	1,280	1,396
Total noncurrent assets	3,638	2,692
Total assets	117,038	82,534
Liabilities, mezzanine equity and equity
Current liabilities:
Accounts payable	2,216	2,153
Accrued expenses	5,607	7,212
Current portion of operating lease liabilities	787	486
Deferred revenue	1,350	1,350
Long-term loans, current portion	-	2,184
Other current liabilities	3,806	3,186
Total current liabilities	13,766	16,571
Noncurrent liabilities:
Long-term loans, noncurrent portion	2,167	-
Operating lease liabilities	1,359	578
Deferred revenue	7,925	7,249
Other noncurrent liabilities	-	341
Total noncurrent liabilities	11,451	8,168
Total liabilities	25,217	24,739
Commitments and contingencies
Mezzanine equity
Contingently redeemable noncontrolling interests	5,196	5,258
Equity
Ordinary shares ($0.0001 par value; 500,000,000 shares authorized; 39,141,913 and 39,115,208 shares issued and outstanding as of December 31, 2020 and June 30, 2021, respectively)	4	4
Additional paid-in capital	366,451	369,784
Accumulated deficit	-277,818	-314,114
Accumulated other comprehensive loss	-297	-366
Total BeyondSpring Inc.’s shareholders’ equity	88,340	55,308
Noncontrolling interests	-1,715	-2,771
Total equity	86,625	52,537
Total liabilities, mezzanine equity and equity	117,038	82,534
The accompanying notes are an integral part of these unaudited interim condensed consolidated financial statements.

BEYONDSPRING INC.
UNAUDITED INTERIM CONDENSED CONSOLIDATED STATEMENTS OF
COMPREHENSIVE LOSS FOR THE THREE AND SIX MONTHS ENDED JUNE 30, 2020 AND 2021
(Amounts in thousands of U.S. Dollars (“$”), except for number of shares and per share data)
	Three months ended June 30,			Six months ended June 30,
	2020	2021		2020	2021
	$	$		$	$
Revenue	-	338		-	676
Operating expenses
Research and development	-11,028	-11,332		-24,732	-22,643
General and administrative	-2,589	-8,985		-5,517	-15,432
Loss from operations	-13,617	-19,979		-30,249	-37,399
Foreign exchange gain (loss), net	9	75		-65	44
Interest income	28	29		92	61
Interest expense	-21	-22		-42	-46
Other income	2	3		3	3
Loss before income tax	-13,599	-19,894		-30,261	-37,337
Income tax benefit	-	-		-	-
Net loss	-13,599	-19,894		-30,261	-37,337
Less: Net loss attributable to noncontrolling interests	-846	-586		-1,424	-1,041
Net loss attributable to BeyondSpring Inc.	-12,753	-19,308		-28,837	-36,296
Net loss per share
Basic and diluted	-0.46	-0.49		-1.04	-0.93
Weighted-average shares outstanding
Basic and diluted	27,921,026	39,010,855		27,826,737	39,007,749
Other comprehensive loss, net of tax of nil:
Foreign currency translation adjustment gain (loss)	-2	-148		51	-75
Comprehensive loss	-13,601	-20,042		-30,210	-37,412
Less: Comprehensive loss attributable to noncontrolling interests	-848	-615		-1,430	-1,047
Comprehensive loss attributable to BeyondSpring Inc.	-12,753	-19,427		-28,780	-36,365
The accompanying notes are an integral part of these unaudited interim condensed consolidated financial statements.

FAQ

What were BeyondSpring's earnings results for Q2 2021?

BeyondSpring reported a net loss of $19.3 million for Q2 2021, compared to $12.8 million in Q2 2020.

What is the significance of the DUBLIN-3 trial results for BYSI?

The DUBLIN-3 trial showed significant improvements in overall survival for patients receiving plinabulin in combination with docetaxel, offering a potential advancement in treatment options.

What partnership did BeyondSpring announce regarding plinabulin?

BeyondSpring entered an exclusive commercialization and co-development agreement with Hengrui Pharmaceuticals for plinabulin in Greater China.

What are the projected financial expectations for BeyondSpring?

The company has sufficient cash reserves at $76.3 million to support ongoing clinical programs but faces increasing operating expenses.

When is the PDUFA date for plinabulin's review in CIN prevention?

The PDUFA date for plinabulin in preventing chemotherapy-induced neutropenia is November 30, 2021.