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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 10, 2022
ANEBULO PHARMACEUTICALS, INC
(Exact name of Registrant as Specified in Its Charter)
| Delaware | 001-40388 | 85-1170950 | ||
|
(State or Other Jurisdiction of Incorporation) |
(Commission File Number) |
(IRS Employer Identification No.) |
|
Anebulo Pharmaceuticals, Inc. 1415 Ranch Road 620 South, Suite 201 Lakeway, TX |
78734 | |
| (Address of Principal Executive Offices) | (Zip Code) |
Registrant’s Telephone Number, Including Area Code: (512) 598-0931
Not Applicable
(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:
| ☐ | Written communications 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, $.0.001 par value per share | ANEB | The Nasdaq Global Market |
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).
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 10, 2022, Anebulo Pharmaceuticals, Inc., a Delaware corporation (the “Company”), issued a press release announcing its financial results for the quarter ended September 30, 2022 and providing a business update. A copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K.
The information in this Current Report on Form 8-K (including Exhibit 99.1) shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such a filing.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits
|
Exhibit Number |
Description | |
| 99.1 | Press Release dated November 10, 2022 | |
| 104 | Cover Page of 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.
| ANEBULO PHARMACEUTICALS, INC. | ||
| Date: November 10, 2022 | By: | /s/ Simon Allen |
| Simon Allen | ||
| Chief Executive Officer (Principal Executive Officer) | ||
Exhibit 99.1
Anebulo Pharmaceuticals Reports First Quarter Fiscal Year 2023 Financial Results and Recent Updates
AUSTIN, Texas (November 10, 2022) – Anebulo Pharmaceuticals, Inc. (Nasdaq: ANEB), a clinical-stage biopharmaceutical company developing novel solutions for people suffering from acute cannabinoid intoxication and substance abuse (the “Company” or “Anebulo”), today announced financial results for the three months ended September 30, 2022 and recent updates.
First Quarter Fiscal Year 2023 and Subsequent Highlights:
| ● | Announced positive interim data for ANEB-001 from Part B of its Phase 2 clinical trial for Acute Cannabinoid Intoxication in September, 2022 |
| ● | Announced $6.6 million private placement financing in September, 2022 |
| ● | Announced the appointment of Nat Calloway, Ph.D. to Board of Directors |
| ● | Company Executives are scheduled to participate in the following investor conferences: |
| ○ | Benchmark Discovery Conference, December 1, 2022 |
| ○ | J.P. Morgan 41st Annual Healthcare Conference 2023, January 9-12, 2023 |
| ○ | BIO CEO and Investor Conference, February 6-9, 2023 |
Management Commentary
“We remain very pleased that Part B of our ongoing Phase 2 clinical trial is progressing on schedule and we look forward to announcing additional results in the near future,” stated Simon Allen, Chief Executive Officer of Anebulo. “Preparations are ongoing for an observational study in ACI subjects in the emergency department setting to further support the PK/PD model and ANEB-001 development.”
Financial Results for the three months ended September 30, 2022
| ● | Operating expenses in the first quarter of fiscal 2023 were $2.6 million compared with $1.6 million in the same period in fiscal 2022. | |
| ● | Net loss in the first quarter of fiscal 2023 was $2.6 million, or $(0.11) per share, compared with a net loss of $1.6 million, or $(0.07) per share, in the first quarter of fiscal 2022. | |
| ● | Cash burn in the first quarter of fiscal 2023 was $2.0 million. | |
| ● | Cash was $19.2 million as of September 30, 2022. |
About Anebulo Pharmaceuticals, Inc.
Anebulo Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company developing novel solutions for people suffering from acute cannabinoid intoxication and substance abuse. Its lead product candidate, ANEB-001, is intended to reverse the negative effects of acute cannabinoid intoxication within one hour of administration. ANEB-001 is a competitive antagonist at the human cannabinoid receptor type 1 (CB1). For further information about Anebulo, please visit www.anebulo.com.
Forward-Looking Statements
This press release contains forward-looking statements as defined in Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These forward-looking statements, along with terms such as “anticipate,” “expect,” “intend,” “may,” “will,” “should” and other comparable terms, involve risks and uncertainties because they relate to events and depend on circumstances that will occur in the future. Those statements include statements regarding the intent, belief or current expectations of Anebulo Pharmaceuticals and members of its management, as well as the assumptions on which such statements are based. Prospective investors are cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties, including risks attendant to developing, testing and commercializing the company’s product candidates, and those described in Anebulo Pharmaceutical’s most recent annual report on Form 10-K and in other periodic reports filed with the SEC, and that actual results may differ materially from those contemplated by such forward-looking statements. Except as required by federal securities law, Anebulo Pharmaceuticals undertakes no obligation to update or revise forward-looking statements to reflect changed conditions.
CONTACTS:
Anebulo Pharmaceuticals, Inc.
Scott Anderson
Head of Investor Relations and Public Relations
(858) 229-7063
scott@anebulo.com
Rex Merchant
Chief Financial Officer
(512) 598-0931
IR@anebulo.com
Condensed Balance Sheet Data
| September 30, | June 30, | |||||||
| 2022 | 2022 | |||||||
| Cash | $ | 19,213,697 | $ | 14,548,471 | ||||
| Total assets | 19,815,365 | 15,579,431 | ||||||
| Total liabilities | 698,179 | 512,531 | ||||||
| Total stockholders’ equity | 19,117,186 | 15,066,900 | ||||||
Condensed Statements of Operations
| Three Months Ended September 30, | ||||||||
| 2022 | 2021 | |||||||
| Research and development | $ | 1,223,776 | $ | 715,098 | ||||
| General and administrative | 1,388,271 | 839,826 | ||||||
| Total operating expenses | 2,612,047 | 1,554,924 | ||||||
| Loss from operations | (2,612,047 | ) | (1,554,924 | ) | ||||
| Other income, net | 212 | 1,529 | ||||||
| Net loss | $ | (2,611,835 | ) | $ | (1,553,395 | ) | ||
| Weighted average common shares outstanding, basic and diluted | 23,416,495 | 23,344,567 | ||||||
| Net loss per share, basic and diluted | $ | (0.11 | ) | $ | (0.07 | ) | ||