false 0001641631 0001641631 2024-11-11 2024-11-11 iso4217:USD xbrli:shares iso4217:USD xbrli:shares

 

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

 

FORM 8-K

 

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the

Securities Exchange Act of 1934

 

Date of report (Date of earliest event reported): November 11, 2024

 

Beyond Air, Inc.

(Exact Name of Registrant as Specified in Charter)

 

Delaware   001-38892   47-3812456

(State or Other Jurisdiction

of Incorporation)

 

(Commission

File Number)

 

(I.R.S. Employer

Identification No.)

 

900 Stewart Avenue, Suite 301

Garden City, NY 11530

(Address of Principal Executive Offices and Zip Code)

 

(516) 665-8200

Registrant’s Telephone Number, Including Area Code

 

(Former Name or Former Address, if Changed Since Last Report)

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

 

  Written communication pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
     
  Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
     
  Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
     
  Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

Securities registered pursuant to Section 12(b) of the Act:

 

Title of each class   Trading Symbol(s)   Name of each exchange on which registered
Common Stock, par value $.0001 per share   XAIR   The Nasdaq Stock Market LLC

 

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (17 CFR §230.405) or Rule 12b-2 of the Securities Exchange Act of 1934 (17 CFR §240.12b-2).

 

Emerging growth company

 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

 

 

 

 
 

 

Item 2.02. Results of Operations and Financial Condition.

 

On November 11, 2024, Beyond Air, Inc. (the “Company”) issued a press release announcing financial results for its fiscal quarter ended September 30, 2024. A copy of the press release is attached hereto as Exhibit 99.1, and is incorporated herein by reference.

 

This information, including the exhibit 99.1 attached hereto, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, except as shall be expressly set forth by specific reference in such filing.

 

Item 9.01 Financial Statements and Exhibits.

 

(d) Exhibits.

 

Exhibit

No.

  Description
99.1   Press Release from Beyond Air, Inc., dated as of November 11, 2024.
104   Cover Page Interactive Data File (embedded within the inline XBRL document).

 

 
 

 

SIGNATURES

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

  BEYOND AIR, Inc.
     
Date: November 18, 2024 By: /s/ Steven A. Lisi
  Name: Steven A. Lisi
  Title Chief Executive Officer

 

 

 

Exhibit 99.1

 

 

Beyond Air® Reports Fiscal Second Quarter 2025 Financial Results and Provides Corporate Update

 

Revenues increased 17% compared to the previous quarter ended June 30, 2024

 

Strengthened balance sheet is expected to provide sufficient cash runway through June 2026

 

Completed a $20.6 million private placement offering with multiple healthcare-focused institutional funds and Company insiders

 

Retired $17.5 million in debt from Avenue Capital and entered into a $11.5 million loan agreement with an insider-led investor group

 

Conference call scheduled for 4:30 p.m. ET today, November 11th

 

Garden City, NY, November 11, 2024 Beyond Air, Inc. (NASDAQ: XAIR) (“Beyond Air” or the “Company”), a commercial stage medical device and biopharmaceutical company focused on harnessing the power of nitric oxide (NO) to improve the lives of patients, today announced its financial results for the fiscal second quarter ended September 30, 2024, and provided a corporate update.

 

“Our commercial strategy continued to drive results throughout the quarter with our total number of customers increasing by over 60%,” said Steve Lisi, Chairman and Chief Executive Officer of Beyond Air. “We believe this is just the beginning of a pivotal year for our Company as we leverage our expanding network of reference customers that have implemented LungFit PH in their hospitals. We have a strong foundation of customer success stories that speak to the cost savings, workflow improvements and additional value our technology delivers in a real-world setting, compared to traditional cylinder-based systems. In addition, since joining our team four months ago, our new Chief Commercial Officer, David Webster, has won key partners to rapidly accelerate our topline growth, including TrillaMed, Healthcare Links and Business Asia Consultants, among others, resetting our commercial strategy and reorganizing our sales, marketing and support teams.”

 

Lisi added: “Our executive team and board of directors have taken decisive actions this year to enhance the Company’s financial health and commercial execution as we continue accelerating our revenue growth. We recently implemented a capital conservation strategy to preserve cash, executed a series of financial transactions that increased our capital resources and eliminated approximately $12 million in debt-related payments through mid-2026. We are confident that these strategic initiatives, in conjunction with projected revenue growth, will extend our cash runway to support our current operating plans through June 2026.”

 

 
 

 

Recent Commercial Execution, Portfolio Highlights and Upcoming Milestones

 

LungFit® PH

 

Commercial Execution

 

Increased commercial demand for LungFit PH, as evidenced by:

 

§A 17% increase in revenue for the quarter ended September 30, 2024, compared with the previous quarter ended June 30, 2024
§The number of hospital contracts increased by 60% over the course of the second fiscal quarter of 2025
§Announced the U.S. Naval Hospital Guam has deployed the LungFit PH system in its mission to provide top-tier neonatal care
§Annualized contracted revenue was $3.5 million on October 1, 2024; with an additional four hospitals slated to start later in fiscal 3Q 2025 further increasing the annualized run rate

 

Entered a strategic partnership with Healthcare Links, a renowned healthcare advisory and contracting firm, that will focus on expanding access to the LungFit® PH system by streamlining entry into Group Purchasing Organizations (GPOs) and Integrated Delivery Networks (IDNs) across the United States
Partnered with Business Asia Consultants, Inc. - an international sales, marketing and business development consulting company with extensive experience in Europe, the Pacific Rim and Latin America - to help accelerate the global expansion of the LungFit PH
Partnered with TrillaMed, a premier provider of medical supplies and technologies to government and healthcare systems globally, to bring LungFit PH to the U.S. Veterans Administration and Department of Defense hospitals

 

Pipeline Highlights

 

Cardiac surgery PMA supplement review ongoing at FDA

 

§Currently no FDA approved nitric oxide system is labeled for cardiac surgery
§Approval would increase LungFit PH’s rate of market penetration and support long-term revenue growth

 

A decision on CE Mark for LungFit PH in Europe expected before year-end 2024
LungFit PH transport-ready PMA supplement submission to FDA anticipated in CY 1Q 2025

 

2
 

 

Beyond Cancer - Solid Tumor Program

 

Clinical Development Execution

 

Ultra-high concentration Nitric Oxide (UNO) therapy is in an ongoing Phase 1a trial evaluating advanced, relapsed or refractory unresectable, primary or metastatic cutaneous and subcutaneous solid tumors

 

§Promising preclinical data presented in two posters at the Society for Immunotherapy of Cancer (SITC) Annual Meeting 2024 showed the efficacy of low volume (LV) UNO – less than 10% of the UNO dose that showed an acceptable safety profile in the ongoing Phase 1a study – when combined with immune checkpoint inhibitors. In a study using MAT B III tumor-bearing rats, LV UNO combined with anti-rPD-L1 doubled the tumor growth inhibition rate and led to improved survival outcomes compared to anti-rPD-L1 alone. Based on these data, the Beyond Cancer team believes LV UNO may positively influence PD-1 progressors and broaden the pool of patients who could benefit from immunotherapy, including those previously ineligible for treatment
§Upon clearance from regulators in Israel, expected shortly, a Phase 1b trial is planned to enroll up to 20 subjects with prior exposure to anti-PD-1 antibody that have either progressed, not achieved a response, or have prolonged stable disease (≥ 12 weeks) on single agent anti-PD-1 without radiographic evidence of continued tumor reduction. Subjects enrolled in the Phase 1b trial will be treated with UNO + anti-PD-1 combination

 

Beyond Cancer intends to seek additional capital to perform human studies in addition to the planned Phase Ib trial

 

Recent Corporate Updates

 

Completed a private placement offering for gross proceeds of approximately $20.6 million, which included participation by multiple healthcare-focused institutional funds, as well as Company insiders
Retired $17.5 million in Avenue Capital debt, eliminating approximately $12 million in debt-related payments through June 2026. In addition, Avenue Capital invested $3.35 million in the private placement offering
Entered into an $11.5 million loan agreement with an insider-led investor group, which utilizes an 8% royalty on net sales beginning in July 2026 to repay the loan. The royalty would cease upon complete loan repayment

 

3
 

 

Financial Results for the Fiscal Second Quarter Ended September 30, 2024

 

Revenues for the fiscal quarter ended September 30, 2024 were $0.8 million compared to $0.2 million for the fiscal quarter ended September 30, 2023 and $0.7 million for the previous quarter ended June 30, 2024. Cost of revenue of $1.9 million was recognized for the three months ended September 30, 2024, compared to $0.4 million for the three months ended September 30, 2023. Cost of revenue exceeded revenue primarily driven by depreciation of LungFit devices and one-time upgrade costs to systems.

 

Research and development expenses for the three months ended September 30, 2024, were $4.6 million as compared to $7.1 million for the three months ended September 30, 2023. The decrease of $2.5 million was primarily attributed to a decrease in salaries, stock-based compensation and pre-clinical studies expenses.

 

Selling, general and administrative expenses for the three months ended September 30, 2024 and September 30, 2023 were $7.2 million and $10.2 million, respectively. The decrease of $3.0 million was attributed primarily to a reduction in stock-based compensation cost.

 

Other income and expense for the three months ended September 30, 2024 was a loss of $1.2 million compared to a gain of $0.1 million for the three months ended September 30, 2023. The decrease of $1.3 million was mainly due to the impact of the partial retirement of the Avenue Capital debt. Cash burn in the fiscal quarter ended September 30, 2024, excluding financing and one-time items was $11.5 million.

 

As of September 30, 2024, the Company reported cash, cash equivalents, and marketable securities of $28.4 million, and total debt outstanding of $12.5 million. Due to the timing of cash settlements associated with the aforementioned financial transactions that were completed subsequent to September 30, 2024, pro forma cash was $18.5 million, and pro forma outstanding debt was $11.5 million. The Company’s strengthened balance sheet, along with our cash conservation strategy and anticipated revenue growth, is expected to provide sufficient cash runway to support current operating plans through June 2026.

 

Conference Call & Webcast

 

Monday, November 11th @ 4:30 PM ET

 

Domestic:1-877-407-0784
International:1-201-689-8560
Conference ID: 13749670
Webcast:A webcast of the live conference call can be accessed by visiting the Events section of the Company’s website (click here) or directly (click here). An online replay will be available on the Company’s website or via the direct link an hour after the call.

 

4
 

 

About Beyond Air®, Inc.

 

Beyond Air is a commercial stage medical device and biopharmaceutical company dedicated to harnessing the power of endogenous and exogenous nitric oxide (NO) to improve the lives of patients suffering from respiratory illnesses, neurological disorders, and solid tumors. The Company has received FDA approval for its first system, LungFit® PH, for the treatment of term and near-term neonates with hypoxic respiratory failure. Beyond Air is currently advancing its other revolutionary LungFit systems in clinical trials for the treatment of severe lung infections such as viral community-acquired pneumonia (including COVID-19), and nontuberculous mycobacteria (NTM) among others. Also, the Company has also partnered with The Hebrew University of Jerusalem to advance a pre-clinical program dedicated to the treatment of autism spectrum disorder (ASD) and other neurological disorders. Additionally, Beyond Cancer, Ltd., an affiliate of Beyond Air, is investigating ultra-high concentrations of NO with a proprietary delivery system to target certain solid tumors in the pre-clinical setting. For more information, visit www.beyondair.net.

 

About LungFit®*

 

Beyond Air’s LungFit is a cylinder-free, phasic flow generator and delivery system and has been designated as a medical device by the U.S. Food and Drug Administration (FDA). The ventilator compatible version of the device can generate NO from ambient air on demand for delivery to the lungs at concentrations ranging from 1 ppm to 80 ppm. The LungFit system could potentially replace large, high-pressure NO cylinders providing significant advantages in the hospital setting, including greatly reducing inventory and storage requirements, improving overall safety with the elimination of NO2 purging steps, and other benefits. LungFit can also deliver NO at concentrations at or above 80 ppm for potentially treating severe acute lung infections in the hospital setting (e.g. COVID-19, bronchiolitis) and chronic, refractory lung infections in the home setting (e.g. NTM). With the elimination of cylinders, Beyond Air intends to offer NO treatment in the home setting.

 

* Beyond Air’s LungFit PH is approved for commercial use only in the United States of America to treat term and near-term neonates with hypoxic respiratory failure. Beyond Air’s other LungFit systems are not approved for commercial use and are for investigational use only. Beyond Air is not suggesting NO use over 80 ppm or use at home.

 

About PPHN

 

Persistent pulmonary hypertension of the newborn (PPHN) is a lethal condition and secondary to failure of normal circulatory transition at birth. It is a syndrome characterized by elevated pulmonary vascular resistance (PVR) that causes labile hypoxemia due to decreased pulmonary blood flow and right-to-left shunting of blood. Its incidence has been reported as 1.9 per 1000 live births (0.4–6.8/1000 live births) with mortality rate ranging between 4–33%. This syndrome complicates the course of about 10% of infants with respiratory failure and remains a source of considerable morbidity and mortality. NO gas is a vasodilator, is approved in dozens of countries to improve oxygenation and reduces the need for extracorporeal membrane oxygenation (ECMO) in term and near-term (>34 weeks gestation) neonates with hypoxic respiratory failure associated with clinical or echocardiographic evidence of pulmonary hypertension in conjunction with ventilator support and other appropriate agents.

 

5
 

 

About Beyond Cancer, Ltd.

 

Beyond Cancer, Ltd., an affiliate of Beyond Air, Inc., is a development-stage biopharmaceutical and medical device company utilizing (UNO via a proprietary delivery platform to treat primary tumors and prevent metastatic disease. Nitric oxide at ultra-high concentrations has been reported to show anticancer properties and to potentially serve as a chemosensitizer and radiotherapy enhancer. A first-in-human study is underway in patients with solid tumors. The Company is conducting preclinical studies of UNO in multiple solid tumor models to inform additional treatment protocols.

 

For more information, visit www.beyondcancer.com.

 

Forward Looking Statements

 

This press release contains “forward-looking statements” concerning the potential safety and efficacy of inhaled nitric oxide and the ultra-high concentration nitric oxide product candidate, as well as its therapeutic potential in a number of indications; and the potential impact on patients and anticipated benefits associated with inhaled nitric oxide and the ultra-high concentration nitric oxide product candidate. Forward-looking statements include statements about expectations, beliefs, or intentions regarding product offerings, business, results of operations, strategies or prospects. You can identify such forward-looking statements by the words “appears,” “expects,” “plans,” “anticipates,” “believes” “expects,” “intends,” “looks,” “projects,” “goal,” “assumes,” “targets” and similar expressions and/or the use of future tense or conditional constructions (such as “will,” “may,” “could,” “should” and the like) and by the fact that these statements do not relate strictly to historical or current matters. Rather, forward-looking statements relate to anticipated or expected events, activities, trends or results as of the date they are made. Because forward-looking statements relate to matters that have not yet occurred, these statements are inherently subject to risks and uncertainties that could cause actual results to differ materially from any future results expressed or implied by the forward-looking statements. These forward-looking statements are only predictions and reflect views as of the date they are made with respect to future events and financial performance. Many factors could cause actual activities or results to differ materially from the activities and results anticipated in forward-looking statements, including risks related to the ability to raise additional capital; the timing and results of future pre-clinical studies and clinical trials; the potential that regulatory authorities, including the FDA and comparable non-U.S. regulatory authorities, may not grant or may delay approval for our product candidates; the approach to discover and develop novel drugs, which is unproven and may never lead to efficacious or marketable products; the ability to fund and the results of further pre-clinical studies and clinical trials of our product candidates; obtaining, maintaining and protecting intellectual property utilized by products; obtaining regulatory approval for products; competition from others using similar technology and others developing products for similar uses; dependence on collaborators; and other risks, which may, in part, be identified and described in the “Risk Factors” section of Beyond Air’s most recent Annual Report on Form 10-K and other of its filings with the Securities and Exchange Commission, all of which are available on Beyond Air’s website. Beyond Air and Beyond Cancer undertake no obligation to update, and have no policy of updating or revising, these forward-looking statements, except as required by applicable law.

 

CONTACTS:

 

Investor Relations contacts

Corey Davis, Ph.D.

LifeSci Advisors, LLC

Cdavis@lifesciadvisors.com

(212) 915-2577

 

6
 

 

BEYOND AIR, INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED BALANCE SHEETS

(amounts in thousands, except share and per share data)

 

   September 30, 2024   March 31, 2024 
   (Unaudited)     
ASSETS          
Current assets          
Cash and cash equivalents  $28,447   $11,378 
Marketable securities   -    23,090 
Restricted cash   230    230 
Accounts receivable   556    319 
Inventory, net   2,527    2,127 
Other current assets and prepaid expenses   6,275    6,792 
Total current assets   38,036    43,936 
Licensed right to use technology   1,325    1,427 
Right-of-use lease assets   1,897    2,121 
Property and equipment, net   11,648    9,364 
Other assets   105    113 
TOTAL ASSETS  $53,010   $56,961 
           
LIABILITIES AND STOCKHOLDERS’ EQUITY          
Current liabilities          
Accounts payable  $1,490   $1,948 
Accrued expenses and other current liabilities   4,470    8,402 
Operating lease liability, current portion   381    418 
Loans payable, current portion   258    800 
Total current liabilities   6,599    11,567 
           
Operating lease liability, net   1,690    1,898 
Long-term debt, net   10,940    14,721 
Long term liability, related party   4,427    - 
Warrant Liability   60    275 
Derivative liability   -    1,314 
Total liabilities   23,716    29,775 
           
Stockholders’ equity          
Preferred Stock, $0.0001 par value per share: 10,000,000 shares authorized, 0 shares issued and outstanding   -    - 
Common Stock, $0.0001 par value per share: 100,000,000 shares authorized, 72,187,636 and 45,900,821 shares issued and outstanding as of September 30, 2024 and March 31, 2024, respectively   7    5 
Treasury stock   (25)   (25)
Additional paid-in capital   293,391    264,780 
Accumulated deficit   (265,255)   (239,697)
Accumulated other comprehensive income (loss)   9    (15)
Total stockholders’ equity attributable to Beyond Air, Inc   28,127    25,048 
Non-controlling interest   1,167    2,138 
Total equity   29,294    27,186 
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY  $53,010   $56,961 

 

7
 

 

BEYOND AIR, INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS

(amounts in thousands, except share and per share data)

(UNAUDITED)

 

   For the Three Months Ended   For the Six Months Ended 
   September 30,   September 30, 
   2024   2023   2024   2023 
                 
Revenues  $798   $239   $1,481   $298 
                     
Cost of revenues   1,882    432    2,897    735 
                     
Gross loss   (1,084)   (193)   (1,416)   (437)
                     
Operating expenses:                    
                     
Research and development   (4,585)   (7,130)   (10,594)   (11,826)
Selling, general and administrative   (7,163)   (10,211)   (14,402)   (21,147)
Total Operating expenses   (11,748)   (17,342)   (24,995)   (32,972)
                     
Loss from Operations   (12,833)   (17,535)   (26,412)   (33,410)
                     
Other income (expense)                    
Dividend/interest income   150    641    511    1,050 
Interest and finance expense   (927)   (914)   (1,891)   (1,072)
Change in fair value of warrant liability   (4)   324    214    647 
Change in fair value of derivative liability   256    500    1,314    1,012 
Foreign exchange gain/ (loss)   74    (42)   (72)   (34)
Loss on extinguishment of debt   (624)   -    (624)   - 
Loss on disposal of fixed assets   (171)   -    (171)   - 
Estimated liability for contingent loss   -    (400)   -    (598)
Other income / (expense)   49    -    48    (77)
Total other income/ (expense)   (1,196)   109    (671)   929 
                     
Net loss before income taxes  $(14,029)  $(17,426)  $(27,083)  $(32,481)
                     
Provision for income taxes   -    -    -    - 
                     
Net loss  $(14,029)  $(17,426)  $(27,083)  $(32,481)
                     
Less : net loss attributable to non-controlling interest   (671)   (1,205)   (1,525)   (2,165)
                     
Net loss attributable to Beyond Air, Inc.   (13,358)   (16,220)   (25,559)   (30,315)
                     
Foreign currency translation loss   (79)   (35)   24    (9)
Comprehensive loss attributable to Beyond Air, Inc.  $(13,438)  $(16,255)  $(25,535)  $(30,325)
                     
Net basic and diluted loss per share attributable to Beyond Air, Inc.  $(0.28)  $(0.51)  $(0.55)  $(0.96)
                     
Weighted average number of shares, outstanding, basic and diluted   47,118,535    31,800,492    46,513,005    31,592,880 

 

8

v3.24.3
Cover
Nov. 11, 2024
Cover [Abstract]  
Document Type 8-K
Amendment Flag false
Document Period End Date Nov. 11, 2024
Entity File Number 001-38892
Entity Registrant Name Beyond Air, Inc.
Entity Central Index Key 0001641631
Entity Tax Identification Number 47-3812456
Entity Incorporation, State or Country Code DE
Entity Address, Address Line One 900 Stewart Avenue
Entity Address, Address Line Two Suite 301
Entity Address, City or Town Garden City
Entity Address, State or Province NY
Entity Address, Postal Zip Code 11530
City Area Code (516)
Local Phone Number 665-8200
Written Communications false
Soliciting Material false
Pre-commencement Tender Offer false
Pre-commencement Issuer Tender Offer false
Title of 12(b) Security Common Stock, par value $.0001 per share
Trading Symbol XAIR
Security Exchange Name NASDAQ
Entity Emerging Growth Company false

Beyond Air (NASDAQ:XAIR)
Historical Stock Chart
From Nov 2024 to Dec 2024 Click Here for more Beyond Air Charts.
Beyond Air (NASDAQ:XAIR)
Historical Stock Chart
From Dec 2023 to Dec 2024 Click Here for more Beyond Air Charts.